Polen, Hyla H; Khanfar, Nile M; Clauson, Kevin A
The pharmaceutical industry spends billions of dollars annually on direct-to-consumer advertising (DTCA). Patient perspectives on the impact of televised DTCA on health-related behaviors and issues were assessed by means of a 68-question survey. 58.6% of respondents believed that DTCA allowed consumers to have a more active role in managing their health. However, 27.6% felt DTCA caused confusion, and an alarming 17.8% of respondents stopped taking their medication because of concerns about serious side effects mentioned in DTCA. Overall, participants believed DTCA plays a useful role in health self-management; however, a considerable percentage thought that the cost outweighs the benefits.
Suh, Hae Sun; Lee, Donghyun; Kim, Sang Yong; Chee, Dong Hyun; Kang, Hye-Young
To examine consumers' attitudes toward direct-to-consumer advertising (DTCA) for prescription drugs in Korea. We conducted a survey of 350 patients visiting community pharmacies to fill their prescriptions. Consumers' attitudes toward DTCA were assessed in terms of whether they felt DTCA was necessary, their trust in the information provided by DTCA, and their intention to use the information provided by DTCA. We examined consumers' preferences regarding the regulation of DTCA and their expectations of the effects of DTCA. About 60% of the respondents responded that DTCA is necessary and that they intended to use the information from DTCA. Less than half of the respondents reported that they would trust DTCA information. About 70% of the participants expressed the need for prior vetting of the DTCA content. Respondents had the highest expectation on the effect of DTCA as an information source for patients. Positive consumer expectations regarding the effects of DTCA were significantly associated with positive consumer attitudes toward DTCA (odds ratio=4.70, 95% confidence interval: 2.25-9.82). This study provides evidence that consumers in South Korea generally have positive attitudes toward DTCA. However, most of the respondents wanted a prior examination system of DTCA content to ensure that the information conveyed to them via DTCA was trustworthy. Policy-makers should be cautious and well-prepared if they decide to introduce DTCA in Korea. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
Ju, Ilwoo; Park, Jin Seong
This study addresses a void in the literature on direct-to-consumer prescription drug advertising (DTCA) with a theory-based content analysis. The findings indicate that Taylor's communication strategy wheel provides insight into what and how pharmaceutical marketers communicate with consumers by means of DTCA. Major findings are summarized as follows: (a) In most DTC ads, informational and transformational message themes and creative approaches were simultaneously used, indicating a combination strategy; (b) DTCA message themes were associated with creative strategies in alignment with Taylor's framework; and (c) message themes and creative strategies varied across therapeutic categories and DTCA categories with different levels of ad spending. Theoretical and practical implications of the findings are discussed.
Ju, Ilwoo; Park, Jin Seong
The literature shows that the prominence of risk disclosure influences consumer responses to direct-to-consumer advertising of prescription drugs. However, little is known about the psychological process whereby disclosure prominence exerts its influences on health beliefs and behavior. Based on a review of the literature on health cognition and behavior, the current study proposed and tested a model to show that risk disclosure prominence affects consumers' drug choice intention through the mediating roles of awareness of drug adverse reactions (ARs), perceived control over ARs, and perceived risk of ARs. The findings were discussed in terms of their theoretical and managerial implications.
Advertising and promotion of Food and Drug Administration (FDA)-approved medical products has been one of the most controversial and bitterly litigated areas in food and drug law in the U.S. for more than a decade. Hundreds of newspaper articles and dozens of law review articles have been written on the subject of the risks and benefits of direct to consumer advertising (DTCA) of medical products, but until very recently virtually all of this literature and commentary has focused exclusively on prescription and over-the-counter drugs. Even when FDA has sponsored public hearings to address the issue of DTCA of all medical products, as it did in 2005, review of the content of the speakers' presentations reveals that almost all of the subject matter, nearly all of the data, and the majority of comments concerned DTCA of drugs. Not a single law review article has ever been devoted exclusively to the subject of advertising and promotion of medical devices to consumers--until now.
Abstract. Ethiopia prohibited direct-to-consumer advertising (DTCA) for any drug product since the early 1980s. This total drug advertising prohibition is rare, and possibly unique, in the world. The purpose of this study was to determine the knowledge and perceptions of health professionals on issues regarding DTCA.
van de Pol, P.K.C.; de Bakker, F.G.A.
Direct-to-consumer advertising (DTCA) of prescription drugs has been a heavily contested issue over the past decade, touching on several issues of responsibility facing the pharmaceutical industry. Much research has been conducted on DTCA, but hardly any studies have discussed this topic from a
Frosch, Dominick L; Grande, David
In 2007, the pharmaceutical industry spent more than $4.9 billion on direct-to-consumer advertising (DTCA) of prescription drugs in the U.S. Controversy over DTCA has grown since the Food and Drug Administration liberalized its regulations in 1997. Proponents claim that such advertising educates consumers, promotes patient participation in clinical decisions, and improves patient adherence to medication instructions. Opponents argue that such advertising is meant to persuade, not educate, and that it promotes inappropriate use of prescription drugs, or diverts consumers from better alternatives. This Issue Brief summarizes the evidence about the effects of DTCA, and proposes guidelines for improving the utility of prescription drug advertising.
Wu, Min H; Bartz, Deborah; Avorn, Jerry; Seeger, John D
Despite much speculation about the role of direct-to-consumer advertising (DTCA) in increasing demand for prescription contraceptives in the United States, there is little published research on this topic. We sought to quantify the prevalence and magnitude of DTCA for prescription contraceptives over the last decade. Using cross-sectional data from January 2005 through December 2014, we performed descriptive analyses on trends in DTCA expenditure for prescription contraceptives. We also quantified the amount of DTCA according to contraceptive method category and individual brand. During the study period, pharmaceutical companies spent a total of US$1.57 billion in the United States on DTCA of prescription contraceptives. Annual expenditure for contraceptive DTCA reached a peak value of US$260 million in 2008, with a progressive decline to a nadir of US$69 million by 2013. Of the contraceptive methods, oral contraceptive pills (OCPs) have been the most heavily promoted, with Yaz (drospirenone/ethinyl estradiol) - the most advertised brand - accounting for US$347 million of cumulative DTCA expenditure. However, DTCA spending on OCPs peaked in 2007 and was overtaken in 2012 by the DTCA of long-acting reversible contraceptives (LARCs), the contraceptive method now receiving the largest amount of DTCA promotion. DTCA is a major form of promotion for prescription contraceptives. Recent trends in DTCA expenditure indicate a shift from promotion of the OCPs to the LARCs. DTCA's effect on provider and patient utilization of various contraceptive methods has yet to be determined. This study provides the first quantitative evaluation of DTCA of prescription contraceptive methods and reveals DTCA's importance as a form of promotion. Recent DTCA trends indicate increased promotion of LARCs, coinciding with greater uptake of LARC methods by patients and prescribers. Copyright © 2016 Elsevier Inc. All rights reserved.
Adeoye, Sanjo; Bozic, Kevin J
Physicians, health plans, hospitals, pharmaceutical companies, and medical device manufacturers have all recognized the benefits of marketing their products and services directly to the end user. As a result, there has been tremendous growth of direct-to-consumer advertising (DTCA), illustrated by the increase in spending on DTCA related to prescription drugs from an estimated $55 million in 1991 to $3.2 billion in 2003. This increase in DTCA has sparked vigorous debate among the major stakeholders in healthcare over the benefits and drawbacks of advertising directly to the healthcare consumer. Issues with DTCA include its impact on the doctor-patient relationship, patient education, inappropriate resource utilization, healthcare costs, healthcare quality, and overall patient wellbeing. Orthopaedic surgery is no longer insulated from this expanding trend in DTCA, as orthopaedic surgeons and hospitals are responsible for a substantial portion of DTCA related to orthopaedic devices and procedures. The Food and Drug Administration has a limited regulatory role and limited power related to DTCA due to considerable inefficiencies in its review and disciplinary processes. Therefore, physicians, including orthopaedic surgeons, must take a leadership role on this issue to ensure the integrity of information provided to patients and to protect the sanctity of the doctor-patient relationship.
Gellad, Ziad F; Lyles, Kenneth W
Since the US Food and Drug Administration (FDA) released new guidelines on broadcast direct-to-consumer advertising in 1997, the prevalence of direct-to-consumer advertising of prescription drugs has increased exponentially. The impact on providers, patients, and the health care system is varied and dynamic, and the rapid changes in the last several years have markedly altered the health care landscape. To continue providing optimal medical care, physicians and other health care providers must be able to manage this influence on their practice, and a more thorough understanding of this phenomenon is an integral step toward this goal. This review will summarize the history of direct-to-consumer drug advertisements and the current regulations governing them. It will summarize the evidence concerning the impact of direct-to-consumer advertising on the public, providers, and the health care system, and conclude with observations regarding the future of direct-to-consumer advertising.
Mackey, Tim K.; Cuomo, Raphael E.; Liang, Bryan A.
Background Pharmaceutical marketing is undergoing a major shift in the United States, in part due to new transparency regulations under the healthcare reform act. Changes in pharmaceutical marketing practices include a possible shift from more traditional forms of direct-to-consumer advertising towards emerging use of Internet-based DTCA (?eDTCA?) given the growing importance of digital health or ?eHealth.? Though legally allowed only in the U.S. and New Zealand, eDTCA poses novel regulatory ...
Liu, Yifei; Doucette, William R
In the United States, direct-to-consumer advertising (DTCA) has grown rapidly to promote prescription medications, including analgesics. Few studies in the literature directly examine the association between DTCA and patients' choice of pain medications. This article discusses how DTCA affects such choice from a behavioral perspective, because DTCA-prompted behaviors are important indicators of DTCA's influence. After DTCA exposure, patients may request prescriptions, seek further medication information, and ask about advertised conditions. Patients who suffer from pain may seek more communication with their health care providers because they are cautious about the information quality of DTCA, mainly because of the recall of rofecoxib (Vioxx; Merck, Whitehouse Station, NJ). However, the availability and DTCA of over-the-counter analgesics complicate their treatment choice. Patients could use DTCA as a tool to launch health communication and make an informed treatment choice with the guidance of their health care providers.
Full Text Available There is growing international concern about the risks posed by direct-to-consumer advertising (DTCA of prescription pharmaceuticals, including via the internet. Recent trade agreements negotiated by the United States, however, incorporate provisions that may constrain national regulation of DTCA. Some provisions explicitly mention DTCA; others enable foreign investors to seek compensation if new regulations are seen to harm their investments. These provisions may thus prevent countries from restricting DTCA or put them at risk of expensive legal action from companies seeking damages due to restrictions on advertising. While the most recent example, the Trans-Pacific Partnership Agreement (TPP, collapsed following US withdrawal in January 2017, early indications of the Trump Administration’s trade policy agenda signal an even more aggressive approach on the part of the United States in negotiating advantages for American businesses. Furthermore, the eleven remaining TPP countries may decide to proceed with the agreement in the absence of the United States, with most of the original text (including the provisions relevant to DTCA intact.
Gleeson, Deborah; Menkes, David B
There is growing international concern about the risks posed by direct-to-consumer advertising (DTCA) of prescription pharmaceuticals, including via the internet. Recent trade agreements negotiated by the United States, however, incorporate provisions that may constrain national regulation of DTCA. Some provisions explicitly mention DTCA; others enable foreign investors to seek compensation if new regulations are seen to harm their investments. These provisions may thus prevent countries from restricting DTCA or put them at risk of expensive legal action from companies seeking damages due to restrictions on advertising. While the most recent example, the Trans-Pacific Partnership Agreement (TPP), collapsed following US withdrawal in January 2017, early indications of the Trump Administration's trade policy agenda signal an even more aggressive approach on the part of the United States in negotiating advantages for American businesses. Furthermore, the eleven remaining TPP countries may decide to proceed with the agreement in the absence of the United States, with most of the original text (including the provisions relevant to DTCA) intact. © 2018 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Weissman, Joel S; Blumenthal, David; Silk, Alvin J; Newman, Michael; Zapert, Kinga; Leitman, Robert; Feibelmann, Sandra
We surveyed a national sample of 643 physicians on events associated with visits during which patients discussed an advertised drug. Physicians perceived improved communication and education but also thought that direct-to-consumer advertising (DTCA) led patients to seek unnecessary treatments. Physicians prescribed the advertised drug in 39 percent of DTCA visits but also recommended lifestyle changes and suggested other treatments. Referring to visits when the DTCA drug was prescribed, 46 percent said that it was the most effective drug, and 48 percent said that others were equally effective. Prescribing DTCA drugs when other effective drugs are available warrants further study.
William Encinosa; Chad Meyerhoefer; Samuel Zuvekas; Dongyi Du
Direct-to-consumer advertising (DTCA) for drugs has increased from US$200 million in 1997 to US$4 billion in 2011. While studies show that DTCA impacts the patient-physician relationship, little is known of the effect of DTCA on health insurance markets. We test whether DTCA raises the costs in these markets or makes the markets more efficient in drug pricing. Across 212 markets, we examine the impact of DTCA on insurers’ negotiated prices for 166 drugs. Controlling for unobserv...
Atherly, Adam; Rubin, Paul H
In this paper we use published information to analyze the economic value of Direct to Consumer Advertising (DTCA). The reviewed research finds that DTCA leads to increased demand for the advertised drug and that the effect of the drug tends to be class-wide rather than product specific. There is weak evidence that DTCA may increase compliance and improve clinical outcomes. However, there is little research on the effect of DTCA on inappropriate prescribing or on the characteristics of patients who respond to treatment. On net, if the advertised drugs are cost effective on average and the patients using the drugs in response to the advertisement are similar to other users, DTCA is likely cost effective. Overall, the literature to date is consistent with the idea that DTCA is beneficial, but further research is needed before definitive conclusions can be drawn.
Mackey, Tim K; Cuomo, Raphael E; Liang, Bryan A
Pharmaceutical marketing is undergoing a major shift in the United States, in part due to new transparency regulations under the healthcare reform act. Changes in pharmaceutical marketing practices include a possible shift from more traditional forms of direct-to-consumer advertising towards emerging use of Internet-based DTCA ("eDTCA") given the growing importance of digital health or "eHealth." Though legally allowed only in the U.S. and New Zealand, eDTCA poses novel regulatory challenges, as it can cross geopolitical boundaries and impact health systems and populations outside of these countries. We wished to assess whether changes in DTCA and eDTCA expenditure trends was occurring using publicly available pharmaceutical marketing data. DTCA data was analyzed to compare trends in aggregate marketing expenditures and to assess if there were statistically significant differences in trends and magnitudes for data sources and DTCA sub-categories (including eDTCA). This was accomplished using regression lines of DTCA trend data and conducting pairwise comparisons of regression coefficients using t-tests. Means testing was utilized for comparing magnitude of DTCA expenditure. Data from multiple data sources indicate that aggregate DTCA expenditures have slightly declined during the period from 2005-2009 and are consistent with results from other studies. For DTCA sub-categories, television remained the most utilized form of DTCA, though experienced trends of declining expenditures (-13.2 %) similar to other traditional media platforms such as radio (-30.7 %) and outdoor ads (-12.1 %). The only DTCA sub-category that experienced substantial increased expenditures was eDTCA (+109.0 %) and it was the only medium that had statistically significant differences in its marketing expenditure trends compared to other DTCA sub-categories. Our study indicates that traditional DTCA marketing may be on the decline. Conversely, the only DTCA sub-category that experienced
Law, Michael R; Soumerai, Stephen B; Adams, Alyce S; Majumdar, Sumit R
Direct-to-consumer advertising (DTCA) is assumed to be a major driver of rising pharmaceutical costs. Yet, research on how it affects costs is limited. Therefore, we studied clopidogrel, a commonly used and heavily marketed antiplatelet agent, which was first sold in 1998 and first direct-to-consumer advertised in 2001. We examined pharmacy data from 27 Medicaid programs from 1999 through 2005. We used interrupted time series analysis to analyze changes in the number of units dispensed, cost per unit dispensed, and total pharmacy expenditures after DTCA initiation. In 1999 and 2000, there was no DTCA for clopidogrel; from 2001 through 2005, DTCA spending exceeded $350 million. Direct-to-consumer advertising did not change the preexisting trend in the number of clopidogrel units dispensed per 1000 enrollees (P = .10). However, there was a sudden and sustained increase in cost per unit of $0.40 after DTCA initiation (95% confidence interval, $0.31-$0.49; P consumer advertising was not associated with an increase in clopidogrel use over and above preexisting trends. However, Medicaid pharmacy expenditures increased substantially after the initiation of DTCA because of a concomitant increase in the cost per unit. If drug price increases after DTCA initiation are common, there are important implications for payers and for policy makers in the United States and elsewhere.
Weissman, Joel S; Blumenthal, David; Silk, Alvin J; Zapert, Kinga; Newman, Michael; Leitman, Robert
We conducted a national telephone survey about health care experiences associated with direct-to-consumer advertising (DTCA) of prescription drugs. Among the 35 percent of our sample who had a physician visit during which DTCA was discussed, 25 percent received a new diagnosis, of which 43 percent were considered high priority according to authoritative sources. More than half also reported actions taken by their physician other than prescribing the advertised drug. Despite concerns about DTCA's negative consequences, we found no differences in health effects between patients who took advertised drugs and those who took other prescription drugs.
Ball, Jennifer Gerard; Manika, Danae; Stout, Patricia
Direct-to-consumer pharmaceutical advertising (DTCA) studies have typically focused on older adults or a general population of adults. However, college students are viable targets for DTCA and are receiving more research attention in this area. In this article, we compare college students with two adult age segments. Our findings indicate all age groups had relatively high awareness of DTCA and similar attitudes and behavioral responses to the ads. However, there were significant differences in media use and health characteristics as well as the factors predicting DTCA ad trust, attitudes, and behavioral intentions. Implications and future research suggestions are discussed.
Elizabeth A Almasi
Full Text Available Only two industrialized countries, the United States and New Zealand, allow direct-to-consumer advertising (DTCA of prescription medicines, although New Zealand is planning a ban. The challenge for these governments is ensuring that DTCA is more beneficial than harmful. Proponents of DTCA argue that it helps to inform the public about available treatments and stimulates appropriate use of drugs for high-priority illnesses (such as statin use in people with ischemic heart disease. Critics argue that the information in the adverts is often biased and misleading, and that DTCA raises prescribing costs without net evidence of health benefits.
Almasi, Elizabeth A; Stafford, Randall S; Kravitz, Richard L; Mansfield, Peter R
Only two industrialized countries, the United States and New Zealand, allow direct-to-consumer advertising (DTCA) of prescription medicines, although New Zealand is planning a ban. The challenge for these governments is ensuring that DTCA is more beneficial than harmful. Proponents of DTCA argue that it helps to inform the public about available treatments and stimulates appropriate use of drugs for high-priority illnesses (such as statin use in people with ischemic heart disease). Critics argue that the information in the adverts is often biased and misleading, and that DTCA raises prescribing costs without net evidence of health benefits.
Park, Jin Seong
This study examined whether seniors' exposure to direct-to-consumer advertising (DTCA) for Alzheimer's disease (AD) medicine contributes to his or her subjective and objective knowledge of AD. A self-administered survey was conducted with a sample of 626 US seniors who were registered for an online consumer research panel. The study found that (1) exposure to DTCA for AD medicine was positively related to seniors' subjective knowledge of AD, (2) DTCA exposure had no significant relationship with overall objective knowledge of AD, and (3) DTCA exposure might influence knowledge of specific features of AD. Although DTCA for AD medicine may induce people to "feel" knowledgeable about AD, it may not result in an equivalent increase in actual knowledge. Therefore, to enhance doctor-patient interactions, both patients and doctors should be aware that although DTCA delivers important and potentially useful health information, it does not necessarily enhance actual knowledge. © The Author(s) 2014.
DeLorme, Denise E; Huh, Jisu
This study provides insight into seniors' perceptions of and responses to direct-to-consumer prescription drug advertising (DTCA) usefulness, examines support for DTCA regulation as a type of uncertainty management, and extends and gives empirical voice to previous survey results through methodological triangulation. In-depth interview findings revealed that, for most informants, DTCA usefulness was uncertain and this uncertainty stemmed from 4 sources. The majority had negative responses to DTCA uncertainty and relied on 2 uncertainty-management strategies: information seeking from physicians, and inferences of and support for some government regulation of DTCA. Overall, the findings demonstrate the viability of uncertainty management theory (Brashers, 2001, 2007) for mass-mediated health communication, specifically DTCA. The article concludes with practical implications and research recommendations.
Spence, Michele M; Teleki, Stephanie S; Cheetham, T Craig; Schweitzer, Stuart O; Millares, Mirta
Spending on direct-to-consumer advertising (DTCA) of prescription drugs has increased dramatically in the past several years. An unresolved question is whether such advertising leads to inappropriate prescribing. In this study, the authors use survey and administrative data to determine the association of DTCA with the appropriate prescribing of cyclooxygenase-2 (COX-2) inhibitors for 1,382 patients. Treatment with either a COX-2 or a traditional nonsteroidal anti-inflammatory drug (NSAID) was defined as appropriate or not according to three different definitions of gastrointestinal risk. Patients who saw or heard a COX-2 advertisement and asked their physician about the advertised drug were significantly more likely to be prescribed a COX-2 (versus a NSAID, as recommended by evidence-based guidelines) than all other patients. Findings also suggest that some patients may benefit from DTCA. The authors discuss the need for balanced drug information for consumers, increased physician vigilance in prescribing appropriately, and further study of DTCA.
Bozic, Kevin J; Smith, Amanda R; Hariri, Sanaz; Adeoye, Sanjo; Gourville, John; Maloney, William J; Parsley, Brian; Rubash, Harry E
Direct-to-consumer advertising (DTCA) has become an influential factor in healthcare delivery in the United States. We evaluated the influence of DTCA on surgeon and patient opinions and behavior in orthopaedics by surveying orthopaedic surgeons who perform hip and knee arthroplasties and patients who were scheduled to have hip or knee arthro-plasty. Respondents were asked for their opinions of and experiences with DTCA, including the influence of DTCA on surgeon and patient decision making. Greater than 98% of surgeon respondents had experience with patients who were exposed to DTCA. The majority of surgeon respondents reported DTCA had an overall negative impact on their practice and their interaction with patients (74%), and their patients often were confused or misinformed about the appropriate treatment for their condition based on an advertisement (77%). Fifty-two percent of patient respondents recalled seeing or hearing advertisements related to hip or knee arthroplasty. These patients were more likely to request a specific type of surgery or brand of implant from their surgeon and to see more than one surgeon before deciding to have surgery. Direct-to-consumer advertising seems to play a substantial role in surgeon and patient decision making in orthopaedics. Future efforts should be aimed at improving the quality and accuracy of information contained in consumer-directed advertisements related to orthopaedic implants and procedures.
Semin, Semih; Aras, Sahbal; Guldal, Dilek
While several major problems concerning drugs occur in the world, the attempts to direct-to-consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives' work efficiency; drug reimbursement restrictions; and the escalating role of the Internet in the consumer market. Some of the main disadvantages of the DTCA are: increasing drug expenditures, unnecessary drug consumption and adverse effect risks. Even though the influence of pharmaceuticals on health services and the economy hold the same importance in the developed and developing countries, its negative consequences have increased by encompassing developing countries in its grip. Therefore, in this review, using Turkey as an example, the situation of direct-to-consumer advertisements in developing countries is analysed in relation with developed countries.
Every-Palmer, Susanna; Duggal, Rishi; Menkes, David B
The last decade has seen increasing measures aimed at regulating the influence of 'Big Pharma' following a number of scandals relating to unethical marketing. Despite these international trends, New Zealand continues to tolerate direct-to-consumer advertising (DTCA) of prescription medication, a controversial pharmaceutical marketing strategy that has been prohibited in all but two countries in the industrialised world. While the pharmaceutical industry asserts that DTCA is informational and empowers consumers, in this viewpoint article we argue that DTCA is a heavily biased source of health information that favours representation of benefits over harms, and is associated with unnecessary prescribing, iatrogenic harm and increased costs to the taxpayer. In this paper, we show that DTCA provides unbalanced information to consumers who may misconstrue DTCA as public health messages, and fail to recognise inherent commercial bias. We describe how DTCA has been linked with inappropriate prescribing and overtreatment, with evidence indicating that patients request and receive specific medications in response to DTCA, even when treatment is not clinically indicated. This exposes patients to unnecessary adverse effects and iatrogenic harm, and increases costs for the health-care sector through the prescription of expensive branded medication. We use local examples to illustrate these points. New Zealand remains an outlier in allowing DTCA to continue which, in our view, is a controversial and harmful practice. The available evidence suggests that consumers and health care professionals are generally opposed to DTCA. Therefore, we believe that the New Zealand government should review its stance on DTCA.
Liang, Bryan A; Mackey, Timothy K
Direct-to-consumer advertising (DTCA), linked to inappropriate medication use and higher health care expenditures, is the fastest growing form of pharmaceutical marketing. DTCA is legal only in the United States and New Zealand. However, the advent of online interactive social media "Web 2.0" technologies-that is, eDTCA 2.0-may circumvent DTCA legal proscriptions. The purpose of this study was to assess the prevalence of DTCA of leading pharmaceutical company presence and drug product marketing in online interactive social media technologies (eDTCA 2.0). We conducted a descriptive study of the prevalence of eDTCA 2.0 marketing in the top 10 global pharmaceutical corporations and 10 highest grossing drugs of 2009. All pharmaceutical companies reviewed (10/10, 100%) have a presence in eDTCA 2.0 on Facebook, Twitter/Friendster, sponsored blogs, and really simple syndication (RSS) feeds. In addition, 80% (8/10) have dedicated YouTube channels, and 80% (8/10) developed health care communication-related mobile applications. For reviewed drugs, 90% (9/10) have dedicated websites, 70% (7/10) have dedicated Facebook pages, 90% (9/10) have health communications-related Twitter and Friendster traffic, and 80% (8/10) have DTCA television advertisements on YouTube. We also found 90% (9/10) of these drugs had a non-corporate eDTCA 2.0 marketing presence by illegal online drug sellers. Pharmaceutical companies use eDTCA 2.0 to market themselves and their top-selling drugs. eDTCA 2.0 is also used by illicit online drug sellers. Regulators worldwide must take into account the current eDTCA 2.0 presence when attempting to reach policy and safety goals.
Arney, Jennifer; Street, Richard L; Naik, Aanand D
Direct-to-consumer advertising (DTCA) is ubiquitous in media outlets, but little is known about the ways in which consumers' values, needs, beliefs, and biases influence the perceived meaning and value of DTCA. This article aims to identify the taxonomy of readership categories that reflect the complexity of how health care consumers interact with DTCA, with particular focus on individuals' perceptions of print DTCA in popular magazines. Respondent-driven sampling was used to recruit 18 male and female magazine readers and 18 male and female prescription medication users aged 18-71 years. Semi-structured, in-depth interviews with consumers about their attentiveness, motivations, perceived value, and behavioral responses to DTCA were conducted. The analyses were guided by principles of grounded theory analysis; four categories that vary in consumers' attentiveness, motivations, perceived value, and behavioral responses to DTCA were identified. Two categories - the lay physician and the informed shopper - see value in information from DTCA and are likely to seek medical care based on the information. One category - the voyeur - reads DTCA, but is not likely to approach a clinician regarding advertised information. The fourth category - the evader - ignores DTCA and is not likely to approach a clinician with DTCA information. Responses to DTCA vary considerably among consumers, and physicians should view patients' understanding and response to DTCA within the context of their health-related needs. Patients' comments related to DTCA may be used as an opportunity to engage and understand patients' perspectives about illness and medication use. Clinicians may use information about these categories to facilitate shared understanding and improve communication within the doctor-patient relationship.
Liang, Bryan A
Background Direct-to-consumer advertising (DTCA), linked to inappropriate medication use and higher health care expenditures, is the fastest growing form of pharmaceutical marketing. DTCA is legal only in the United States and New Zealand. However, the advent of online interactive social media “Web 2.0” technologies—that is, eDTCA 2.0—may circumvent DTCA legal proscriptions. Objective The purpose of this study was to assess the prevalence of DTCA of leading pharmaceutical company presence and drug product marketing in online interactive social media technologies (eDTCA 2.0). Methods We conducted a descriptive study of the prevalence of eDTCA 2.0 marketing in the top 10 global pharmaceutical corporations and 10 highest grossing drugs of 2009. Results All pharmaceutical companies reviewed (10/10, 100%) have a presence in eDTCA 2.0 on Facebook, Twitter/Friendster, sponsored blogs, and really simple syndication (RSS) feeds. In addition, 80% (8/10) have dedicated YouTube channels, and 80% (8/10) developed health care communication-related mobile applications. For reviewed drugs, 90% (9/10) have dedicated websites, 70% (7/10) have dedicated Facebook pages, 90% (9/10) have health communications-related Twitter and Friendster traffic, and 80% (8/10) have DTCA television advertisements on YouTube. We also found 90% (9/10) of these drugs had a non-corporate eDTCA 2.0 marketing presence by illegal online drug sellers. Conclusion Pharmaceutical companies use eDTCA 2.0 to market themselves and their top-selling drugs. eDTCA 2.0 is also used by illicit online drug sellers. Regulators worldwide must take into account the current eDTCA 2.0 presence when attempting to reach policy and safety goals. PMID:21880574
Arney, Jennifer; Street, Richard L; Naik, Aanand D
Direct-to-consumer advertising (DTCA) is ubiquitous in media outlets, but little is known about the ways in which consumers’ values, needs, beliefs, and biases influence the perceived meaning and value of DTCA. This article aims to identify the taxonomy of readership categories that reflect the complexity of how health care consumers interact with DTCA, with particular focus on individuals’ perceptions of print DTCA in popular magazines. Respondent-driven sampling was used to recruit 18 male and female magazine readers and 18 male and female prescription medication users aged 18–71 years. Semi-structured, in-depth interviews with consumers about their attentiveness, motivations, perceived value, and behavioral responses to DTCA were conducted. The analyses were guided by principles of grounded theory analysis; four categories that vary in consumers’ attentiveness, motivations, perceived value, and behavioral responses to DTCA were identified. Two categories – the lay physician and the informed shopper – see value in information from DTCA and are likely to seek medical care based on the information. One category – the voyeur – reads DTCA, but is not likely to approach a clinician regarding advertised information. The fourth category – the evader – ignores DTCA and is not likely to approach a clinician with DTCA information. Responses to DTCA vary considerably among consumers, and physicians should view patients’ understanding and response to DTCA within the context of their health-related needs. Patients’ comments related to DTCA may be used as an opportunity to engage and understand patients’ perspectives about illness and medication use. Clinicians may use information about these categories to facilitate shared understanding and improve communication within the doctor–patient relationship. PMID:23378746
Naik, Rupali K; Borrego, Matthew E; Gupchup, Gireesh V; Dodd, Melanie; Sather, Mike R
To assess pharmacy students' knowledge, attitudes, and evaluation of direct-to-consumer advertising (DTCA). A cross sectional, self-administered, 106-item survey instrument was used to assess first, second, and third professional year pharmacy students' knowledge about DTCA regulations, attitudes toward DTCA, and evaluation of DTC advertisements with different brief summary formats (professional labeling and patient labeling) and in different media sources (print and television). One hundred twenty (51.3%) of the 234 students enrolled participated in the study. The mean percentage knowledge score was 48.7% +/- 12.5%. Based on the mean scores per item, pharmacy students had an overall negative attitude toward DTC advertisements. Students had an overall negative attitude toward television and print advertisements using the professional labeling format but an overall positive attitude toward the print advertisement using the patient labeling format. Lectures discussing DTC advertising should be included in the pharmacy curriculum.
Chaar, Betty; Kwong, Kenelm
Direct-to-consumer advertising (DTCA) of over-the-counter or prescribed medicines is a highly controversial issue relating to public health care. Advocates highlight the advantages of DTCA in terms of patient awareness and autonomy. Opponents voice concerns about safety and patients' best interests. The views of physicians and consumers about DTCA have been widely investigated. There has been little research, however, in relation to pharmacists' experiences with DTCA and the impact of DTCA on pharmacy practice. The aim of this study was therefore to explore pharmacists' perceptions of DTCA in Australia and its impact on pharmacy practice. A semi-structured in-depth interview was conducted with a purposive convenience sample of retail pharmacists in Sydney, Australia. Interviews were recorded, transcribed ad verbatim and continued until data saturation. Emerging themes were extracted and analysed according to the grounded theory approach. Pharmacists participating in this study reported concern about potential harm to patient health and well-being as a result of the influence of DTCA. DTCA was seen to impede pharmacists in the discharge of their fundamental ethical responsibilities, leading to a strong sense of disempowerment. Pharmacists' gate-keeping role was challenged by DTCA encouraging consumers to self-medicate and inducing a range of drug-seeking behaviours. Although pharmacists acknowledged that DTCA may have a role in promoting patient autonomy, in practice DTCA compromised their role in safeguarding consumers from inappropriate use of medicines. This study highlighted that the impact of DTCA is not restricted to prescription medicines, but extended also to over-the-counter, pharmacist-only and other pharmacy-related products. Pharmacists perceived that DTCA disempowered them, compromising their role in safeguarding the community from inappropriate medicine use.
DeLorme, Denise E; Huh, Jisu; Reid, Leonard N
This study investigates advertising skepticism in the context of consumers' prescription drug information seeking behavior. Results of a telephone survey found that: (a) the overall level of direct-to-consumer advertising (DTCA) skepticism among consumers was neutral; (b) DTCA skepticism was unrelated to age, positively related to education and income, and varied by race; (c) however, when all the antecedent variables were considered concurrently, only education emerged as a significant predictor (consumers with higher education were more skeptical of DTCA); (d) DTCA skepticism was not significantly related to perceived importance of prescription drug information; (e) DTCA skepticism was not associated with use of advertising and interpersonal sources of prescription drug information; and (f) DTCA skepticism was negatively related to perceived usefulness of advertising sources but unrelated to perceived usefulness of professional interpersonal sources (i.e., physicians and pharmacists). The article concludes with a discussion of findings and directions for future research.
McRoy, Luceta; Weech-Maldonado, Robert; Bradford, W David; Menachemi, Nir; Morrisey, Michael; Kilgore, Meredith
Asthma medication adherence is low, particularly among Medicaid enrollees. There has been much debate on the impact of direct-to-consumer advertising (DTCA) on health care use, but the impact on medication use among children with asthma has been unexamined. The study sample included 180,584 children between the ages of 5 and 18 with an asthma diagnosis from a combined dataset of Medicaid Analytic eXtract and national advertising data. We found that DTCA expenditure during the study period was significantly associated with an increase in asthma medication use. However, the effectiveness declined after a certain level.
Arney, Jennifer; Lewin, Benjamin
The rise of direct-to-consumer advertising (DTCA) has mirrored, if not facilitated, the shift toward more active health care consumers. We used content analysis to identify models of physician-patient interaction in DTCA from the 1997 to 2006 issues of a broad sample of women's, men's, and common readership magazines. We also conducted 36 in-depth interviews to examine the ways consumers receive and regard advertising messages, and to explore their preferences for clinical communication and decision making. We identified four models of physician-patient relationships that vary in their locus of control (physician, patient, or shared) and the form of support sought or obtained in the relationship (emotional or instrumental). Whereas consumer interviews reflected references to all four models of interaction, only two appeared in DTCA. The limited range of interactions seen in these advertisements creates a lack of congruity between interaction styles found in advertisements vs. styles reported by actual consumers.
Dhaval Dave; Henry Saffer
Expenditures on prescription drugs are one of the fastest growing components of national health care spending, rising by almost three-fold between 1995 and 2007. Coinciding with this growth in prescription drug expenditures has been a rapid rise in direct-to-consumer advertising (DTCA), made feasible by the Food and Drug Administration's (FDA) clarification and relaxation of the rules governing broadcast advertising in 1997 and 1999. This study investigates the separate effects of broadcast a...
Lipsky, M S; Taylor, C A
The use of direct-to-consumer advertising (DTCA) by pharmaceutical companies is increasing. Our study examines the opinions and experiences of family physicians concerning DTCA. A survey instrument designed to elicit the opinions, experiences, and perceptions of family physicians about DTCA was sent to a 2% (N = 880) systematic sampling of active physician members of the American Academy of Family Physicians. Descriptive statistics were used to analyze responses with t tests and chi 2 tests for independence used to examine subgroup response differences. Four hundred fifty-four (52%) physicians responded to the survey. Most physicians (95%) had encountered DTCA personally, and had been approached by an average of 7 patients over the previous 6 months with requests for specific prescription drugs. Prescription antihistamines and antihypertensive drugs were the most commonly requested. Overall, 80% of the physician respondents believed that print DTCA was not a good idea, while 84% expressed negative feelings about television and radio advertising. Both groups cited "misleading biased view" and "increased costs" as the most common disadvantages. Some reported benefits included "better informed patients" and "promoting physician-patient communication." Overall, the study group physicians had negative feelings about DTCA in both print and electronic media. Studies directly examining patient perspectives, as well as cost benefits, are necessary to test the validity of the physicians' perceptions about DTCA.
Corrigan, Patrick W; Kosyluk, Kristin A; Fokuo, J Konadu; Park, Jin Hee
Stigma interferes with life goals of people with mental illness. Direct-to-consumer advertising (DTCA) may impact stigmatizing attitudes. The purpose of this study is to examine the effects of psychiatric medication DTCA on the stigmatizing and affirming attitudes of the general population versus individuals self-identified with mental illness. Participants (n = 272) were randomly assigned to watch a DTCA about Cymbalta, an antidepressant, embedded in two other advertisements for non-pharmaceutical products. Participants completed measures of stigmatizing and affirming attitudes before and after viewing this DTCA. Results indicate that the Cymbalta DTCA worsened the attitudes of the general public. These participants were less likely to offer help, endorse recovery, and agree with self-determination attitudes towards people with mental illness following viewing the DTCA. The self-identified group reported less blame, less dangerousness, less social avoidance, more pity, and greater willingness to help after viewing the DTCA. Moreover, there was significant improvement in their endorsement of recovery. Results suggest that DTCAs about psychiatric medication may increase the public's stigma towards people with mental illness but reduce stigma among individuals who identify as having a mental illness. Findings are somewhat limited by selection biases and self-report. Implications for further development of DTCAs are considered.
Kontos, Emily Z; Viswanath, K
The direct-to-consumer advertising (DTCA) phenomenon has received attention because of its attempt to reach out to consumers by bypassing important gatekeepers such as physicians. The emergence of new information platforms and the introduction of genetic tests directly to the consumer have heightened the concern with DTCA and its potential consequences. These effects of DTCA are particularly important given the communication inequalities among social groups, with class, race and ethnicity influencing how people access, seek, process and act on information. This Science and Society article reviews the major issues regarding general and cancer-related DTCA and also offers data from a national survey in the United States as an example of the communication inequalities in genetic testing awareness.
Datti, Balaji; Carter, Mary W
Although older adults are frequent consumers of prescription drugs and increasingly the intended audience of direct-to-consumer advertising (DTCA) marketing efforts, little is known about the effect of DTCA on older adults' prescription drug-seeking behaviour. In response, the objective of this study is to examine factors associated with requesting a prescription drug from a physician following exposure to DTCA among older adults, and whether the drug or other medical treatment was prescribed during the encounter. A secondary data analysis of the "Public Health Impact of Direct-to-Consumer Advertising of Prescription Drugs", a data set publicly available through the Inter-university Consortium for Political and Social Research (ICPSR 3687), was conducted. For the purposes of this study, only those respondents who indicated that they had been exposed to DTCA (n = 2601) were included in the study sample. Using a two-step weighted logistic regression approach, separate models were estimated to examine first, whether a request for the advertised drug was made following exposure to DTCA and secondly, the outcomes of any patient-physician encounters that occurred following exposure to DTCA. Descriptive analysis of the outcome variables revealed that, among respondents exposed to DTCA, 31% (n = 801) requested a prescription drug from their physician. Approximately 5% of those who made a request were > or =75 years of age. Among respondents requesting a prescription drug, 69% (n = 556) received a prescription in response to their request, of whom, approximately 5% were > or =75 years of age. Multivariate findings suggest that although adults > or =75 years of age are less likely to request a prescription drug following exposure to DTCA (odds ratio [OR] = 0.58; p = 0.032), when they do approach their physicians, they are more likely to receive recommendations for further treatment, with ORs indicating a 250% (OR = 3.507; p = 0.002) increase in the odds of further referral
Brown, Seth A
Despite widespread use, little is known about how video direct-to-consumer-advertising (DTCA) influences beliefs about or stigma towards mental illness. The purpose of this study was to examine the effects of a medication advertisement on beliefs and stigma towards one mental disorder-bipolar disorder. A total of 424 participants were randomly assigned to view a medication or automobile advertisement and completed measures of beliefs and stigma towards bipolar disorder before and immediately after the advertisement. The medication advertisement did not lead to changes in perception of biological etiology, but did lead to increases in perception of prevalence, treatability, and controllability. No substantive changes were noted in stigma. In contrast to previous research and speculation, DTCA did not have an immediate, substantial impact on stigma or contribute to the "medicalization" of mental disorders.
Harrington, Amanda R; Desselle, Shane P; Apgar, David A; Hesselbacher, Elizabeth; Pié, Aaron; Quesnel, Aimee; Warholak, Terri L
Direct-to-consumer advertisement (DTCA) of prescription medications has become an important informational source for health care consumers. As future health care professionals on the front line of potential communication and dispensing of products emerging from DTCA, it is important to elicit the attitudes of student-pharmacists. This study aims to (1) evaluate the validity of the DTCA attitudinal questionnaire using Rasch rating scale analysis and (2) investigate the attitudes of pharmacy students toward DTCA and determine whether these attitudes were associated with years of pharmacy education and demographic characteristics. This investigation used a cross-sectional print-based questionnaire to evaluate the attitudes of pharmacy students toward DTCA of prescription medications. The 16-item questionnaire included items addressing the attitudes of pharmacy students toward DTCA with respect to patients' knowledge of medications, pharmacists' interaction with patients, and overall consumer judgment of medical prescriptions. Analyses included Rasch analysis and a multiple linear regression. A total of 243 students submitted usable questionnaires (85% response rate). Item response categories were collapsed from 5 categories to 3, and 4 items were removed to achieve acceptable Rasch model fit. Pharmacy students demonstrated little difficulty in agreeing with the statements suggesting that DTCA helps patients take a more active role in health care and had the most difficulty in agreeing with items suggesting that DTCA may lead to inappropriate prescribing to satisfy patient requests. Students' overall support for DTCA was the only variable that predicted the questionnaire score (P<.001). In conclusion, the Rasch analysis evaluated the psychometric properties of the instrument and identified the necessity to adapt the questionnaire from previous iterations to adequately fit the student population. Future research should examine factors that contribute to the variance in
Hwang, Monica J; Young, Henry N
The educational value of direct-to-consumer advertising (DTCA) of prescription drugs hinges on its ability to convey important benefit and risk information to consumers. However, the literacy level required to understand some of the information presented in print advertisements may hinder DTCA's ability to educate consumers. The objective of this study was to compare the comprehension and retention of benefit and risk information between consumers who viewed an original print DTCA and those who viewed an advertisement modified according to health literacy principles. An experimental design was used to conduct the study. Participants were randomly assigned to view a modified print advertisement (experimental group) or the original print advertisement (control group) for an antidepressant medication. Study participants were recruited from the University of Wisconsin Kidney Clinic. Ten true-false and 10 multiple-choice questions were developed to assess participants' comprehension and retention of benefit and risk information. A total of 120 participants were randomized to view either the original or the modified version of the advertisement. Regarding the comprehension and retention of only the benefit information, no significant differences were observed between the 2 groups. Significant differences were observed for comprehension and retention of only the risk information. The experimental group had significantly higher scores in comprehension (U = 1224; P advertisement were successful in enhancing both consumers' comprehension and their retention of information presented in a print DTCA. This was especially apparent for the risk information. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
Block, Adam E
Direct-to-consumer advertising (DTCA) is legal in the US and New Zealand, but illegal in the rest of the world. Little or no research exists on the social welfare implications of DTCA. To quantify the total costs and benefits associated with both appropriate and inappropriate care due to DTCA, for the case of depression. A cost-benefit model was developed using parameter estimates from available survey, epidemiological and experimental data. The model estimates the total benefits and costs (year 2002 values) of new appropriate and inappropriate care stimulated by DTCA for depression. Uncertainty in model parameters is addressed with sensitivity analyses. This study provides evidence that 94% of new antidepressant use due to DTCA is from non-depressed individuals. However, the average health benefit to each new depressed user is 63-fold greater than the cost per treatment, creating a positive overall social welfare effect; a net benefit of >72 million US dollars. This analysis suggests that DTCA may lead to antidepressant treatment in 15-fold as many non-depressed people as depressed people. However, the costs of treating non-depressed people may be vastly outweighed by the much larger benefit accruing to treated depressed individuals. The cost-benefit ratio can be improved through better targeting of advertisements and higher quality treatment of depression.
Folsom, Craig; Fesperman, Susan F; Tojuola, Bayo; Sultan, Shahnaz; Dahm, Philipp
To investigate direct-to-consumer advertising (DTCA) of prescription drugs that are relevant to urological conditions. Evidence suggests that DTCA of prescription drugs increase pharmaceutical sales. Concern about such advertising methods has recently increased owing to the market withdrawal of heavily marketed drugs that were found to have serious health risks. Three consecutive issues of 26 popular magazines during a 3-month period were screened for urology-related DTCA. Advertisements were abstracted using a standardized evaluation form that was pilot-tested in a separate sample of nonurological advertisements. Variables analyzed included the type of advertisement, claims of effectiveness, references of research studies, inducements, and use of tables, figures, and pictures. We identified 8 unique DTCA in 4 different magazines (Ladies Home Journal, Golf Digest, Sports Illustrated, and Good Housekeeping). All advertisements were disease-specific and targeted patients with benign prostatic hyperplasia-related symptoms (n = 3), incontinence (n = 3), or erectile dysfunction (n = 2). The median number of claims made per DTCA was 3 (range, 2-6). None of the claims made were supported by research data, as presented in tables or figures, or referenced peer-reviewed publications. The most common types of appeals addressed symptom control (8/8), lifestyle improvement (7/8), effectiveness (4/8), and dependability (3/8), while none addressed drug safety. DTCA of prescription drugs for urological conditions are found in select journals and focus on few highly prevalent conditions. None of the advertisement claims identified in this study were supported by research data. There seems to be significant room for improvement in the quality of information provided by urological advertisements. Copyright 2010 Elsevier Inc. All rights reserved.
Mackey, Tim K; Yagi, Nozomi; Liang, Bryan A
Pharmaceutical marketing in the United States had undergone a shift from largely exclusively targeting physicians to considerable efforts in targeting patients through various forms of direct-to-consumer advertising ("DTCA"). This includes the use of DTCA in prescription drug coupons ("PDCs"), a new form of DTCA that offers discounts and rebates directly to consumers to lower costs of drug purchasing. Our examination of PDCs reveals that the use and types of PDC programs is expanding and includes promotion of the vast majority of top grossing pharmaceuticals. However, controversy regarding this emerging form of DTCA has given rise to health policy concerns about their overall impact on prescription drug expenditures for consumers, payers, and the health care system, and whether they lead to optimal long-term utilization of pharmaceuticals. In response to these concerns and the growing popularity of PDCs, what we propose here are clearer regulation and regulatory guidance for PDC DTCA use. This would include review for appropriate disclosure of marketing claims, increased transparency in PDC use for pharmaceutical pricing, and leveraging potential positive benefits of PDC use for vulnerable or underserved patient populations. Copyright © 2014 Elsevier Inc. All rights reserved.
Full Text Available Jennifer Arney,1–3 Richard L Street Jr,2–4 Aanand D Naik2,31Department of Sociology, University of Houston – Clear Lake, 2Houston VA Health Services Research and Development Center of Excellence, Michael E DeBakey Department of Veterans Affairs Medical Center, 3Section on Health Services Research, Baylor College of Medicine, Houston, 4Department of Communication, Texas A&M University, College Station, TX, USAAbstract: Direct-to-consumer advertising (DTCA is ubiquitous in media outlets, but little is known about the ways in which consumers' values, needs, beliefs, and biases influence the perceived meaning and value of DTCA. This article aims to identify the taxonomy of readership categories that reflect the complexity of how health care consumers interact with DTCA, with particular focus on individuals' perceptions of print DTCA in popular magazines. Respondent-driven sampling was used to recruit 18 male and female magazine readers and 18 male and female prescription medication users aged 18–71 years. Semi-structured, in-depth interviews with consumers about their attentiveness, motivations, perceived value, and behavioral responses to DTCA were conducted. The analyses were guided by principles of grounded theory analysis; four categories that vary in consumers' attentiveness, motivations, perceived value, and behavioral responses to DTCA were identified. Two categories – the lay physician and the informed shopper – see value in information from DTCA and are likely to seek medical care based on the information. One category – the voyeur – reads DTCA, but is not likely to approach a clinician regarding advertised information. The fourth category – the evader – ignores DTCA and is not likely to approach a clinician with DTCA information. Responses to DTCA vary considerably among consumers, and physicians should view patients' understanding and response to DTCA within the context of their health-related needs. Patients' comments
Conrad, Peter; Leiter, Valerie
The medicalisation of life problems has been occurring for well over a century and has increased over the past 30 years, with the engines of medicalisation shifting to biotechnology, managed care, and consumers. This paper examines one strand of medicalisation during the last century: direct-to-consumer advertising (DTCA) of pharmaceuticals. In particular, it examines the roles that physicians and the Food and Drug Administration (FDA) have played in regulating DTCA in the US. Two advertising exemplars, the late 19(th) century Lydia E. Pinkham's Vegetable Compound (for 'women's complaints') and contemporary Levitra (for erectile dysfunction) are used to examine the parallels between the patent medicine era and the DTCA era. DTCA re-establishes the direct and independent relationship between drug companies and consumers that existed in the late 19(th) century, encouraging self-diagnosis and requests for specific drugs. The extravagant claims of Lydia Pinkham's day are constrained by laws, but modern-day advertising is more subtle and sophisticated. DTCA has facilitated the impact of the pharmaceutical industry and consumers in becoming more important forces in medicalisation.
Lexchin, Joel; Mintzes, Barbara
Since the mid 1990's, Canada has introduced partial direct-to-consumer advertising (DTCA) of prescription drugs through administrative policy shifts. Little documentation exists on how regulation occurs in practice. To evaluate Health Canada's response to complaints about DTCA. We use case studies about DTCA spanning from 2000 to 2011 to examine the stringency of regulation by Health Canada. The aim was to identify key themes in Health Canada's approach to regulation from a public health perspective. All of the material related to the cases was independently read by each of the authors and any disagreements in interpretation were resolved through discussion. We identified six weaknesses in how Health Canada deals with DTCA: failure to act on concerns about promotion for unapproved "off-label" uses, possible financial inducements to use a product, advertisements perceived to stimulate unwarranted fear about disease risks, and advertising of products with serious safety concerns identified in Health Canada safety advisories; ineffective enforcement actions undertaken by Health Canada; and lack of transparency in Health Canada's decision-making. There is an astonishing degree of discordance between public health priorities and regulation of DTCA in Canada. The current approach to enforcement is notable both for its lack of teeth and lack of accountability and transparency.
Chang, Hsien-Yen; Murimi, Irene; Daubresse, Matthew; Qato, Dima M; Emery, Sherry L; Alexander, G Caleb
The value of direct-to-consumer advertising (DTCA) of prescription drugs is widely debated, as is the effect of DTCA on prescription sales and health care utilization. We examined the association between DTCA intensity for statin medications and prescription sales and cholesterol-related health care utilization. We conducted an ecological study for 75 designated market areas from 2005 to 2009 in the United States using linked data regarding televised DTCA volume, non-DTCA marketing and promotion, retail, mail order and long-term care prescription drug sales, prescription drug and ambulatory care health care utilization, and contextual factors such as health care density and socioeconomic status. Main outcomes and measures were volume of sales, number of dispensed prescriptions, and high cholesterol-related outpatient visits. Analyses were conducted in 2016. The intensity of rosuvastatin and atorvastatin ad exposures per household varied substantially across designated market areas. After adjustment for socioeconomic, demographic, and clinical characteristics, each 100-unit increase in advertisement viewership was associated with a 2.22% [95% confidence interval (CI), 0.30%-4.19%] increase in statin sales. Similar patterns were observed between DTCA and statin dispensing among the commercially insured. DTCA was associated with increases in high cholesterol-related outpatient visits among adults 18-45 years of age (3.15% increase in visits per 100-unit increase in viewership, 95% CI, 0.98%-5.37%) but not among those 46-65 years of age (0.51%, 95% CI, -1.49% to 2.55%). DTCA for statins is associated with increases in statin utilization and hyperlipidemia-related outpatient visits, especially for young adults.
Mackey, Tim K.; Liang, Bryan A.
Pharmaceutical marketing is undergoing a transition as the business, delivery, and consumption of health care have increasingly become part of a growing digital landscape. Changes in pharmaceutical promotion also coincide with federal “sunshine” regulations newly implemented under the Affordable Care Act that require disclosure of certain marketing and industry payments to physicians. Collectively, these trends could lead to fundamental shifts in physician-directed and direct-to-consumer advertising (DTCA) that have yet to be adequately identified or explored. In response, we advocate for greater DTCA transparency, especially in the emerging digital forms of DTCA, to complement forthcoming sunshine transparency data. This will allow more robust study and understanding of changes in overall pharmaceutical marketing trends and their impact on health care consumption and behavior. This can also lead to more targeted state and federal policy interventions leveraging existing federal transparency regulations to ensure appropriate marketing, sales, and consumption of pharmaceutical products. PMID:25583897
Mackey, Tim K; Liang, Bryan A
Pharmaceutical marketing is undergoing a transition as the business, delivery, and consumption of health care have increasingly become part of a growing digital landscape. Changes in pharmaceutical promotion also coincide with federal "sunshine" regulations newly implemented under the Affordable Care Act that require disclosure of certain marketing and industry payments to physicians. Collectively, these trends could lead to fundamental shifts in physician-directed and direct-to-consumer advertising (DTCA) that have yet to be adequately identified or explored. In response, we advocate for greater DTCA transparency, especially in the emerging digital forms of DTCA, to complement forthcoming sunshine transparency data. This will allow more robust study and understanding of changes in overall pharmaceutical marketing trends and their impact on health care consumption and behavior. This can also lead to more targeted state and federal policy interventions leveraging existing federal transparency regulations to ensure appropriate marketing, sales, and consumption of pharmaceutical products. © 2015 Annals of Family Medicine, Inc.
Ball, Jennifer G; Manika, Danae; Stout, Patricia A
Age is an important factor that can influence processing of and response to health messages. Many studies examining evaluations of and responses to direct-to-consumer prescription drug advertising (DTCA) have incorporated age as a predictor variable, moderating variable, or sample criterion. However, findings have been inconsistent. This study attempts to add clarity to this body of research by assessing age differences in the antecedent factors of various DTCA outcomes. A multigroup structural equation modeling analysis revealed several significant differences in variable relationships between older (50+) and younger (behavioral intentions among older adults while showing a straightforward positive association with attention among younger adults. Further analysis indicated that health status accounted for some but not all of the age differences. It is suggested that younger adults are more open to seeking additional information following DTCA exposure, whereas older adults remain ambivalent.
Daubresse, Matthew; Hutfless, Susan; Kim, Yoonsang; Kornfield, Rachel; Qato, Dima M.; Huang, Jidong; Miller, Kay; Emery, Sherry L.
Rationale: The United States is one of only two countries that permit direct-to-consumer advertising (DTCA) of prescription drugs, and many questions remain regarding its effects. Objectives: To quantify the association between asthma-related DTCA, pharmacy sales, and healthcare use. Methods: This was an ecological study from 2005 through 2009 using linked data from Nielsen (DTCA television ratings), the IMS Health National Prescription Audit (pharmacy sales), and the MarketScan Commercial Claims data (healthcare use) for 75 designated market areas in the United States. We used multilevel Poisson regression to model the relationship between DTCA and rates of prescriptions and use within and across designated market areas. Main outcome measures include (1) volume of total, new, and refilled prescriptions for advertised products based on pharmacy sales; (2) prescription claims for asthma medications; and asthma-related (3) emergency department use, (4) hospitalizations, and (5) outpatient encounters among the commercially insured. Measurements and Main Results: Four Food and Drug Administration–approved asthma medicines were advertised during the period examined: (1) fluticasone/salmeterol (Advair), (2) mometasone furoate (Asmanex), (3) montelukast (Singulair), and (4) budesonide/formoterol (Symbicort). After adjustment, each additional televised advertisement was associated with 2% (incident rate ratio, 1.02; 95% confidence interval, 1.01–1.03) higher pharmacy sales rate from 2005 through 2009, although this effect varied across the three consistently advertised therapies examined. Among the commercially insured, DTCA was positively and significantly associated with emergency room visits related to asthma (incident rate ratio, 1.02; 95% confidence interval, 1.01–1.04), but there was no relationship with hospitalizations or outpatient encounters. Conclusions: Among this population, DTCA was associated with higher prescription sales and asthma-related emergency
Daubresse, Matthew; Hutfless, Susan; Kim, Yoonsang; Kornfield, Rachel; Qato, Dima M; Huang, Jidong; Miller, Kay; Emery, Sherry L; Alexander, G Caleb
The United States is one of only two countries that permit direct-to-consumer advertising (DTCA) of prescription drugs, and many questions remain regarding its effects. To quantify the association between asthma-related DTCA, pharmacy sales, and healthcare use. This was an ecological study from 2005 through 2009 using linked data from Nielsen (DTCA television ratings), the IMS Health National Prescription Audit (pharmacy sales), and the MarketScan Commercial Claims data (healthcare use) for 75 designated market areas in the United States. We used multilevel Poisson regression to model the relationship between DTCA and rates of prescriptions and use within and across designated market areas. Main outcome measures include (1) volume of total, new, and refilled prescriptions for advertised products based on pharmacy sales; (2) prescription claims for asthma medications; and asthma-related (3) emergency department use, (4) hospitalizations, and (5) outpatient encounters among the commercially insured. Four Food and Drug Administration-approved asthma medicines were advertised during the period examined: (1) fluticasone/salmeterol (Advair), (2) mometasone furoate (Asmanex), (3) montelukast (Singulair), and (4) budesonide/formoterol (Symbicort). After adjustment, each additional televised advertisement was associated with 2% (incident rate ratio, 1.02; 95% confidence interval, 1.01-1.03) higher pharmacy sales rate from 2005 through 2009, although this effect varied across the three consistently advertised therapies examined. Among the commercially insured, DTCA was positively and significantly associated with emergency room visits related to asthma (incident rate ratio, 1.02; 95% confidence interval, 1.01-1.04), but there was no relationship with hospitalizations or outpatient encounters. Among this population, DTCA was associated with higher prescription sales and asthma-related emergency department use.
Yang, Yi; Gourley, Dick R; Gourley, Greta A; Faris, Richard J; Womeodu, Robin J; Yang, Jun; Likens, Carol C
Previous research on direct-to-consumer advertising (DTCA) has not focused exclusively on the African American population. The purpose of this study was to explore African Americans' attitudes toward proactive health behaviors following exposure to DTCA of atorvastatin calcium (Lipitor, Pfizer Inc). One-hundred fifty African American patients participated in the study. Participants' functional health literacy and health locus of control were assessed. The participants were asked to view a DTCA of Lipitor, followed by face-to-face interviews. After watching the DTCA of Lipitor, 89.4% of participants agreed that they would talk to their physician about their cholesterol, 88.6% agreed that they would ask their physician to test their cholesterol level, and 47.3% agreed that they would ask their physician to write them a prescription for Lipitor. Those who had a history of high cholesterol were more likely to agree to ask their physician to test their cholesterol levels. Low household income, having public health insurance, and prior experience with taking Lipitor were significant positive predictors of patients agreeing to ask their physician to write a prescription of the advertised drug. African American patients showed favorable attitudes toward proactive health behaviors after exposure to DTCA of Lipitor.
Green, Charee E; Mojtabai, Ramin; Cullen, Bernadette A; Spivak, Amethyst; Mitchell, Melissa; Spivak, Stanislav
This study explored the association of exposure to direct-to-consumer advertising (DTCA) with medication nonadherence among individuals with serious mental disorders. Results of an anonymous survey administered at an inner-city mental health clinic were examined by using logistic regression. Nonadherence was defined as not taking prescribed medications for at least two out of seven days. Of 246 respondents, 48% reported DTCA exposure and 43% reported nonadherence. Sixty-one percent of those exposed to DTCA reported nonadherence, compared with 26% of those not exposed (adjusted odds ratio=4.96, 95% confidence interval=2.64-9.33, preporting nonadherence, 59% reported changing medication-taking behaviors or stopping prescribed medications because of side effect information in advertisements. Only a minority communicated with providers before becoming nonadherent. This study found an association between self-report of DTCA exposure and self-reported nonadherence. These results support further research on DTCA as a possible risk factor for nonadherence.
Abel, Gregory A; Burstein, Harold J; Hevelone, Nathanael D; Weeks, Jane C
Although cancer-related direct-to-consumer advertising (CR-DTCA) is prevalent, little is known about cancer patients' experiences with this controversial medium of medical communication. We administered a 41-item, mailed questionnaire to consecutive patients with breast and hematologic malignancies who were undergoing active treatment at our institution. We assessed awareness of CR-DTCA within the prior year, perceptions of CR-DTCA, and CR-DTCA-prompted patient and provider behaviors. We received 348 completed questionnaires (response rate, 75.0%). Overall, 86.2% reported being aware of CR-DTCA, most frequently from television (77.7%). Awareness did not vary with clinical or sociodemographic factors except that patients were more likely to be aware of CR-DTCA for products specific to their cancer types (P advertised medication, although less than one fifth of those reported receiving a prescription for the advertised medication. The patients in our cohort were highly aware of CR-DTCA. CR-DTCA was found to be accessible and useful; however, it decreased some patients' confidence in their providers' judgment. CR-DTCA prompted a modest amount of patient-provider discussion but infrequent patient-reported changes in therapy.
Bell, Robert A; Kravitz, Richard L; Wilkes, Michael S
OBJECTIVE Drug manufacturers are intensely promoting their products directly to consumers, but the impact has not been widely studied. Consumers' awareness and understanding of, attitudes toward, and susceptibility to direct-to-consumer (DTC) drug advertising were examined. DESIGN Random-digit dialing telephone survey with a random household member selection procedure (completion and response rates, 58% and 69%, respectively). SETTING Respondents were interviewed while they were at their residences. PARTICIPANTS Complete data were obtained from 329 adults in Sacramento County, California. MEASUREMENTS AND MAIN RESULTS Outcome measures included awareness of advertisements for 10 selected drugs, misconceptions about DTC advertising, attitudes toward DTC ads, and behavioral responses to such promotions. The influence of demographic characteristics, health status, attitudes, beliefs, and media exposure on awareness and behaviors was examined. On average, respondents were aware of advertisements for 3.7 of the 10 drugs; awareness varied from 8% for Buspar (buspirone) to 72% for Claritin (loratadine). Awareness was associated with prescription drug use, media exposure, positive attitudes toward DTC advertising, poorer health, and insurance status. Substantial misconceptions were revealed; e.g., 43% thought that only “completely safe” drugs could be advertised. Direct-to-consumer advertisements had led one third of respondents to ask their physicians for drug information and one fifth to request a prescription. CONCLUSIONS Direct-to-consumer advertisements are reaching the public, but selectively so, and affecting their behaviors. Implications for public policy are examined. PMID:10571712
Bell, R A; Kravitz, R L; Wilkes, M S
Drug manufacturers are intensely promoting their products directly to consumers, but the impact has not been widely studied. Consumers' awareness and understanding of, attitudes toward, and susceptibility to direct-to-consumer (DTC) drug advertising were examined. Random-digit dialing telephone survey with a random household member selection procedure (completion and response rates, 58% and 69%, respectively). Respondents were interviewed while they were at their residences. Complete data were obtained from 329 adults in Sacramento County, California. Outcome measures included awareness of advertisements for 10 selected drugs, misconceptions about DTC advertising, attitudes toward DTC ads, and behavioral responses to such promotions. The influence of demographic characteristics, health status, attitudes, beliefs, and media exposure on awareness and behaviors was examined. On average, respondents were aware of advertisements for 3.7 of the 10 drugs; awareness varied from 8% for Buspar (buspirone) to 72% for Claritin (loratadine). Awareness was associated with prescription drug use, media exposure, positive attitudes toward DTC advertising, poorer health, and insurance status. Substantial misconceptions were revealed; e.g., 43% thought that only "completely safe" drugs could be advertised. Direct-to-consumer advertisements had led one third of respondents to ask their physicians for drug information and one fifth to request a prescription. Direct-to-consumer advertisements are reaching the public, but selectively so, and affecting their behaviors. Implications for public policy are examined.
Applequist, Janelle; Ball, Jennifer Gerard
In 2015, the American Medical Association called for a ban of direct-to-consumer advertising (DTCA) for prescription drugs. Yet, the pharmaceutical industry spends more than ever on broadcast advertisements, with national health care costs largely driven by drug spending. An evaluation of these ads is critical, as these advertisements can impact the frequency which patients ask their doctors about medications. A content analysis of prime-time direct-to-consumer ads was conducted across 4 major cable television networks. The ad content (n = 61) was coded for factual claims made regarding target conditions, appeals used, portrayal of medications, and lifestyle characteristics shown. We found a substantial decrease in the percentage of ads that conveyed information about the conditions being targeted, such as risk factors (16%) and prevalence (16%). Positive emotional appeals (94%) continued to be emphasized; yet there was decreased use of negative emotional appeals (51%), pointing to an overall more positive portrayal of a patient's experience with a medication. The lifestyles portrayed in the sample largely featured how products can enable more recreational activities (69%) and fewer ads (7%) presented alternatives to product use. Direct-to-consumer advertising continued to promote prescription drugs above educating the population. Improvement in the educational value of DTCA is likely to require regulatory action rather than reliance on self-regulation by the pharmaceutical industry. © 2018 Annals of Family Medicine, Inc.
Abel, Gregory A; Chen, Kun; Taback, Nathan; Hassett, Michael J; Schrag, Deborah; Weeks, Jane C
Little is known about the impact of direct-to-consumer advertising (DTCA) on appropriate versus inappropriate prescribing. Aromatase inhibitor (AI) therapy for breast cancer provides an ideal paradigm for studying this issue, because AIs have been the focus of substantial DTCA, and because they should only be used in postmenopausal women, age can serve as a simple surrogate marker of appropriateness. Data regarding national DTCA spending for the AIs were obtained from TNS Multimedia; hormonal therapy prescription data were obtained from IMS Health. Time series analyses were performed to characterize the association between monthly changes in DTCA spending for the AIs and monthly changes in the proportion of all new hormonal therapy prescriptions represented by the AIs from October 2005 to September 2007. Analyses were stratified by age, considering prescriptions for women ≤ 40 (likely premenopausal) to be inappropriate and those for women > 60 (likely postmenopausal) to be appropriate. Monthly dollars spent on AI-associated DTCA varied considerably ($118,600 to $22,019,660). Time series analysis revealed that for every million dollars spent on DTCA for the AIs, there was an associated increase 3 months later in the new AI prescription proportion of 0.15% for all ages (P 60 years (P < .0001), but no significant change for those ≤ 40 at any time from 0 to 6 months. DTCA for the AIs was associated with increases in appropriate prescriptions with no significant effect on inappropriate prescriptions, suggesting that DTCA may not foster inappropriate medication use for certain drug classes. Copyright © 2012 American Cancer Society.
Avery, Rosemary J; Eisenberg, Matthew D; Simon, Kosali I
We examine whether exposure to direct-to-consumer advertising (DTCA) for antidepressant drugs affects individual use of these medications among those suffering from depression. Prior studies have almost exclusively relied on making connections between national or market-level advertising volume/expenditures and national or individual-level usage of medications. This is the first study to: estimate the impact of individual-level exposure to DTCA on individual-level use of antidepressants; estimate the impact of individual-level exposure to television DTCA on individual-level use in any drug class; consider the relative and interactive impact of DTCA in two different media in any drug class; and, consider the heterogeneity of impact among different populations in an econometric framework in the antidepressant market. There are also important limitations to note. Unlike prior market level studies that use monthly data, we are limited to aggregated annual data. Our measures of potential advertising exposure are constructed assuming that media consumption patterns are stable during the year. We are also not able to study the impact of advertising on use of antidepressants for conditions other than depression, such as anxiety disorders. We find that: DTCA impacts antidepressant use in a statistically and economically significant manner; that these effects are present in both television and magazine advertising exposure but do not appear to have interactive effects; are stronger for women than for men in the magazine medium, but are about equally strong for men and women in the TV medium; and, are somewhat stronger for groups suffering from more severe forms of depression. The overall size of the effect is a 6-10 percentage point increase in antidepressant use from being exposed to television advertising; the corresponding magazine effects are between 3 and 4 percentage points. Copyright © 2012 Elsevier B.V. All rights reserved.
Young, Henry N; Lipowski, Earlene E; Cline, Rebecca J W
Previous research describing consumers' communication behaviors in response to direct-to-consumer advertising (DTCA) suggests a social cognitive rationale to explain DTCA-related communication behavior. Guided by social cognitive theory, the objective of this study was to explore outcome expectancy and self-efficacy beliefs as predictors of individuals' intentions to communicate with their physicians about an advertised drug. One hundred and seven female college students completed a questionnaire, read an advertisement for an oral contraceptive drug, and completed a second questionnaire. The questionnaires assessed participants' self-efficacy and outcome expectancy beliefs, intended communication behavior, and demographic information. Pearson product-moment correlation analyses showed that outcome expectancy (r=0.75, Pbehavior (B=1.56, Padvertised drug [t(106)=14.75, Pconsumers' plans for interacting with physicians in response to DTCA. Health care providers can use these results to guide communication with patients regarding DTCA and meet patients' drug-related informational expectations.
Schommer, Jon C; Hansen, Richard A
The objectives of this article are to (1) identify key methodological issues related to investigating the effects of direct-to-consumer advertising (DTCA) for prescription drugs, (2) highlight opportunities and challenges that these issues pose, and (3) provide suggestions to address these challenges and opportunities from a social and administrative pharmacy perspective. Through a review of existing literature and consultation with research colleagues, we identified 3 broad issues regarding the study of DTCA for prescription drugs: (1) the importance of problem formulation, (2) the role of health behavior and decision-making perspectives, and (3) data collection and data analysis challenges and opportunities. Based upon our findings, we developed recommendations for future research in this area. Clear problem formulation will be instructive for prioritizing research needs and for determining the role that health behavior and decision-making perspectives can serve in DTCA research. In addition, it appears that cluster bias, nonlinear relationships, mediating/moderating effects, time effects, acquiescent response, and case mix are particularly salient challenges for the DTCA research domain. We suggest that problem formulation, selection of sound theories upon which to base research, and data collection and data analysis challenges are key methodological issues related to investigating the effects of DTCA for prescription drugs.
Mackey, Tim K.
The adoption and use of digital forms of direct-to-consumer advertising (also known as "eDTCA") is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the "disruptive" qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored. PMID:27239871
Crawley, LaVera M; Hisaw, Lisa; Illes, Judy
If direct-to-consumer advertising (DTCA) increases consumer participation in healthcare, then it may provide a useful strategy for addressing health disparities, in part, where patient-level barriers have contributed to such disparities. However, this presumes equitable access to DTCA. Using mixed methods, we explored advertisement patterns in matched African American and general audience magazines across a range of genres and ad types. Results suggest no significant differences in ad frequencies by race. However other meaningful categorical and qualitative differences were found, suggesting that advertisers may fall short in maximizing DTCA as an adjunctive strategy for empowering populations at risk for health disparities.
Niederdeppe, Jeff; Byrne, Sahara; Avery, Rosemary J; Cantor, Jonathan
While statin drugs are recommended for secondary prevention of coronary heart disease (CHD), there is no medical consensus on whether or not a statin should be added to lifestyle change efforts for primary prevention of CHD. Previous research suggests that exposure to direct-to-consumer advertising (DTCA) increases drug demand among those at comparatively low risk. Research has yet to examine whether individual-level DTCA exposure may influence statin use among men and women at high, moderate, or low risk for future cardiac events. To determine the relationship between estimated exposure to DTCA for statin drugs and two clinical variables: diagnosis with high cholesterol and statin use. We used logistic regression to analyze repeated cross-sectional surveys of the United States population, merged with data on the frequency of DTCA appearances on national, cable, and local television, between 2001 and 2007. American adults (n=106,685) aged 18 and older. Levels of exposure to statin DTCA, based on ad appearances and TV viewing patterns; self-reports of whether or not a respondent has been diagnosed with high cholesterol, and whether or not a respondent took a statin in the past year. Adjusting for potential confounders, we estimate that exposure to statin ads increased the odds of being diagnosed with high cholesterol by 16 to 20 %, and increased statin use by 16 to 22 %, among both men and women (p<0.05). These associations were driven almost exclusively by men and women at low risk for future cardiac events. There was also evidence of a negative association between DTCA exposure and statin use among high-risk women (p<0.05) CONCLUSIONS: This study provides new evidence that DTCA may promote over-diagnosis of high cholesterol and over-treatment for populations where risks of statin use may outweigh potential benefits.
Schulz, Steven A; Broekemier, Gregory M; Burkink, Tim J
Even with many changes in regulation in recent years, direct-to-consumer advertising (DTCA) of pharmaceutical drugs remains a complicated and contentious issue. Many in our society argue for increased legislation of DTCA while others believe that DTCA serves a useful purpose and should not be overregulated. This study was designed to compare attitudes and beliefs regarding DTCA held by two key stakeholder groups, physicians and pharmaceutical sales representatives. A questionnaire was created, pretested, and administered to 30 physicians and 30 pharmaceutical sales representatives to investigate these issues. Significant differences between these two groups were found and implications for DTCA are discussed.
Montoya, Isaac D; Lee-Dukes, Gwen; Shah, Dhvani
The escalating growth in the development of pharmaceutical drugs has caused the pharmaceutical industry to market drugs directly to consumers. Direct-to-consumer (DTC) advertising has increased immensely in the past 15 years and continues to grow each year. The advantages of DTC advertising include an increase in consumer knowledge, patient autonomy, and possibly providing physicians and pharmacists with up-to-date information about the recent trends in the marketplace. However, there is also an equally notable list of disadvantages, which include concerns about the quality of information provided, loss in physician productivity due to time spent convincing patients that what they want is not in their best interest, and increases in the reimbursement expenditure of the insurers. Because of these conflicting outcomes, the issue of DTC advertising has become controversial. This report offers an overview of DTC advertising and focuses on its effects on physicians, pharmacists, consumers, insurers, the government, and pharmaceutical manufacturers.
Nathenson, Robert; Richards, Michael R
Direct-to-consumer advertising (DTCA) for prescription drugs is a relatively unique feature of the US health care system and a source of tens of billions of dollars in annual spending. It has also garnered the attention of researchers and policymakers interested in its implications for firm and consumer behavior. However, few economic studies have explored the DTCA response to public policies, especially those mandating coverage of these products. We use detailed advertising expenditure data to assess if pharmaceutical firms increase their marketing efforts after the implementation of relevant state and federal health insurance laws. We focus on mental health parity statutes and related drug therapies-a potentially ripe setting for inducing stronger consumer demand. We find no clear indication that firms expect greater value from DTCA after these regulatory changes. DTCA appears driven by other considerations (e.g., product debut); however, it remains a possibility that firms respond to these laws through other, unobserved channels (e.g., provider detailing).
Direct-to-consumer advertising (DCTA) of prescription-only medicines is currently only permitted in the USA and New Zealand. While proponents of DCTA argue that it allows patients to make more informed choices about available treatment options, opponents claim that marketing inevitably presents a biased viewpoint of pharmaceutical products. Frank Auton, senior lecturer in marketing and business strategy at the University of Westminster, UK, presents his case in favor of advertising pharmaceuticals directly to patients.
Liang, Bryan A
Background Illicit or rogue Internet pharmacies are a recognized global public health threat that have been identified as utilizing various forms of online marketing and promotion, including social media. Objective To assess the accessibility of creating illicit no prescription direct-to-consumer advertising (DTCA) online pharmacy social media marketing (eDTCA2.0) and evaluate its potential global reach. Methods We identified the top 4 social media platforms allowing eDTCA2.0. After determining applicable platforms (ie, Facebook, Twitter, Google+, and MySpace), we created a fictitious advertisement advertising no prescription drugs online and posted it to the identified social media platforms. Each advertisement linked to a unique website URL that consisted of a site error page. Employing Web search analytics, we tracked the number of users visiting these sites and their location. We used commercially available Internet tools and services, including website hosting, domain registration, and website analytic services. Results Illicit online pharmacy social media content for Facebook, Twitter, and MySpace remained accessible despite highly questionable and potentially illegal content. Fictitious advertisements promoting illicit sale of drugs generated aggregate unique user traffic of 2795 visits over a 10-month period. Further, traffic to our websites originated from a number of countries, including high-income and middle-income countries, and emerging markets. Conclusions Our results indicate there are few barriers to entry for social media–based illicit online drug marketing. Further, illicit eDTCA2.0 has globalized outside US borders to other countries through unregulated Internet marketing. PMID:23718965
Mackey, Tim Ken; Liang, Bryan A
Illicit or rogue Internet pharmacies are a recognized global public health threat that have been identified as utilizing various forms of online marketing and promotion, including social media. To assess the accessibility of creating illicit no prescription direct-to-consumer advertising (DTCA) online pharmacy social media marketing (eDTCA2.0) and evaluate its potential global reach. We identified the top 4 social media platforms allowing eDTCA2.0. After determining applicable platforms (ie, Facebook, Twitter, Google+, and MySpace), we created a fictitious advertisement advertising no prescription drugs online and posted it to the identified social media platforms. Each advertisement linked to a unique website URL that consisted of a site error page. Employing Web search analytics, we tracked the number of users visiting these sites and their location. We used commercially available Internet tools and services, including website hosting, domain registration, and website analytic services. Illicit online pharmacy social media content for Facebook, Twitter, and MySpace remained accessible despite highly questionable and potentially illegal content. Fictitious advertisements promoting illicit sale of drugs generated aggregate unique user traffic of 2795 visits over a 10-month period. Further, traffic to our websites originated from a number of countries, including high-income and middle-income countries, and emerging markets. Our results indicate there are few barriers to entry for social media-based illicit online drug marketing. Further, illicit eDTCA2.0 has globalized outside US borders to other countries through unregulated Internet marketing.
Full Text Available The increasing prominence of new Internet and social media technologies and their growing importance as a source of health information are pushing the pharmaceutical industry towards digital channels. This paper explores the potential impacts of the pharmaceutical industry’s increasing interest in online marketing and considers how the existing regulatory framework in Canada translates into the social media sphere. Direct-to-consumer advertising (DTCA of prescription drugs is prohibited in Canada, as it is in most industrialized countries. Although Health Canada has reaffirmed that the existing DTCA regulations apply to new Internet and social media technologies, new dynamics such as user-generated content, consumer propagation, and targeted marketing make applying the existing regulations an uncertain process. Moreover, certain problems often associated with DTCA may be exacerbated in the social media context. Finally, there is skepticism around whether government regulators have the resources or political will to effectively monitor new digital media. As such, this paper considers not only the role of direct government regulation in monitoring and enforcing the regulation of DTCA, but also the role of third party oversight and industry self-regulation—both of which may play an important role in filling the gaps in the regulation of the Internet and social media.
Womack, Catherine A
Arguments for and against direct-to-consumer drug advertising (DTCA) center on two issues: (1) the epistemic effects on patients through access to information provided by the ads; and (2) the effects of such information on patients' abilities to make good choices in the healthcare marketplace. Advocates argue that DTCA provides useful information for patients as consumers, including information connecting symptoms to particular medical conditions, information about new drug therapies for those conditions. Opponents of DTCA point out substantial omissions in information provided by the ads and argue that the framing of the ads may mislead patients about the indications, uses, and effectiveness of the drugs advertised. They also suggest that DTCA has a number of potentially negative effects on the doctor-patient relationship. The standard arguments appear to assume a simplistic correlation-more information means more agency for patients. However, empirical studies on medical decision making suggest that this relationship is much more complex and nuanced. I examine recent research on ways in which patients are vulnerable with respect to DTCA. In order to address the complex issues of information acquisition and consumer decision-making in the health care marketplace, the focus should not be simply on what information patients need in order to make medical decisions, but also on the conditions under which patients actually are able to make medical decisions requiring complex medication information. This requires examining both the cognitive limitations of patients with respect to drug information and investigating patients' preferences and needs in a variety of medical contexts.
Park, Jin Seong; Ju, Ilwoo; Kim, Kenneth Eunhan
Although exposure to direct-to-consumer prescription drug advertising (DTCA) is reported to influence the public's beliefs about diseases, no research has investigated how DTCA may affect the extent of consumers' optimistic bias about the future risk of diseases. Based on a survey with members of an online consumer panel (n = 699), the current study revealed that: (a) Consumers exhibited a tendency to believe they were at less risk of developing clinical depression in the future than their peers, demonstrating an optimistic bias. (b) Exposure to antidepressant DTCA acted to reduce the extent of such bias, especially when consumers were less skeptical of prescription drug advertising. When consumers were highly skeptical, DTCA exposure did not significantly relate to the extent of optimistic bias. (c) Once formed, the extent of optimistic bias negatively related to consumers' intention to seek information about depression. Implications of the research for the theory and practice of DTCA were discussed.
Mintzes, Barbara; Barer, Morris; Lexchin, Joel; Bassett, Ken L
Canada is strongly influenced by US cross-border direct-to-consumer advertising (DTCA) and has held consultations to discuss introduction of DTCA since 1996. This article describes a survey of Canadian drug policy experts carried out in 2001, during one such legislative review. The survey results are compared to more recent DTCA policy developments. We recruited key informants on pharmaceutical policy to complete a faxed questionnaire that queried their opinions on DTCA information quality, effects on drug and health care use, and regulatory issues. Respondents were asked about the evidence they had used to back their opinions. Analysis was descriptive. Of 79 identified potential participants, 60 (76%) participated, 40% of whom were from federal and provincial government; 3% were private insurers; 18%, 15%, and 8% were from health professional groups, consumer groups, and patient groups, respectively; 8% and 7% were from pharmaceutical and advertising industries, respectively. Opinions were highly polarized on the effects of DTCA on drug and health care use. Advertising and pharmaceutical industry respondents were generally positive, public sector, health professional and consumer groups generally negative. Over 80% believed DTCA leads to higher private and public drug costs and more frequent physician visits. Fewer judged billboards or television to be appropriate media for DTCA than magazines or the Internet, and most believed that children and adolescents should not be targeted. Given the polarization observed within this survey, we examined how DTCA policy has evolved in Canada since 2001. The federal government has legislative authority over DTCA, but bears few of the additional costs potentially incurred through policy change. These fall to the provinces, which provide an eroding patchwork of public coverage for prescription drugs in the face of rapidly increasing costs. No new federal legislation has been tabled since 2001. However, considerable shifts in
Khanfar, Nile M; Polen, Hyla H; Clauson, Kevin A
A 68-question Internet survey was used to determine the impact of televised direct-to-consumer advertising (DTCA) on consumer-initiated medication changes for the treatment of gastroesophageal reflux disease (GERD) and social anxiety disorder (SAD). Of the 427 respondents, 10% that viewed DTCA for GERD and 6% that viewed DTCA for SAD reported that they subsequently initiated a conversation with their physician. Nearly half of respondents, 47.4% for GERD and 40% for SAD, reported that a change in therapy occurred as a direct result of these discussions. Televised DTCA for these two drug classes can have a significant impact on patient-initiated prescription requests.
Full Text Available The issues surrounding Direct-To-Consumer Advertising of pharmaceuticals are ripe for scrutiny through the lens of Human Rights analysis. Among the human rights most decisively engaged by DTCA is the right to autonomy in health-related decision making, which in turn incorporates right of access to health-related information. The latter incorporates, in part, right of access to reliable and beneficial information through the avenues of commercial speech among others. Another crucial human right is the right not to be harmed by unsafe consumer products through corporate malfeasance or negligence. The most commonly invoked policy options in the context of DTCA are either an outright ban or strengthening regulatory oversight in combination with voluntary guidelines. Banning Direct-To-Consumer Advertising risks being both over inclusive and under inclusive as a policy option. A wholesale ban risks being over inclusive in that it could deprive consumers of information about medications with a positive benefit-risk profile, ones that could enhance their quality of health and well being. Thus it risks being overly paternalistic. Banning DTCA, by itself, is under inclusive in that it is insufficient to address the ways that unadvertised drugs can pose significant risks to consumers. Other policy measures would be most optimal to deal with the very serious deficits in the processes by which prescription drugs undergo clinical trials, and garner regulatory approval prior to their promotion in the marketplace. A more finely tuned approach to regulatory oversight is endorsed, one involving a proactive and precautionary approach reliant upon prior approval. Such an approach could help to address the very serious concerns about potential infringements of the human right not to be harmed by unsafe consumer products through corporate malfeasance or negligence.
Kannan, S; Gowri, S; Tyagi, V; Kohli, S; Jain, R; Kapil, P; Bhardwaj, A
Direct to physician advertisements and direct to consumer advertisement (DTCA) is a well-known marketing strategy of pharmaceutical companies. Studies from the West and also from the Indian sub-continent revealed several lacunae in such advertisements. The present study was carried out to understand the international and national scenario regarding the lacunae in drug advertisements and the opinion of both physicians and patients regarding DTCA. The present study was conducted after obtaining approval from the institutional ethics committee. Warning letters (WLs) issued to pharmaceutical companies by United States Food and Drug Administration (USFDA) and Therapeutic Goods Administration (TGA) due to discrepancies in the advertisements were analyzed for reasons that were grouped into one of the following categories: overstatement of efficacy; unapproved indication; lack of adequate directions to use; omission of adverse effects; misleading claims; advertisement made for an unapproved drug (investigational new product). Drug advertisements in Current Index of Medical Specialties (CIMS) April-July 2014 issue was also analyzed for lacunae depending on categories as mentioned above. Physicians and patients in a tertiary care medical college and hospital were administered a validated questionnaire exploring their views about crucial aspects of DTCA. Descriptive statistics was used for each of the categories. A total of 93 WLs issued by USFDA and 36 by TGA were assessed. Majority of the WLs by USFDA were issued for omission of adverse effects (61/93, 65.6%) followed by misleading claims (54/93, 58.1%). Similarly, WLs by TGA were also mainly issued for the presence of misleading claims (35/36, 97.2%) followed by overstatement of efficacy (26/36, 72.2%) and CIMS evaluation had revealed that 78/92 (84.8%) advertisements omitted adverse effects, 20/92 (21.7%) had misleading claims, 9/92 (9.8%) had unapproved indications and 7/92 (7.6%) overstated the efficacy. With regard to
Barker, Kristin K; Vasquez Guzman, Cirila Estela
Hispanic Americans use prescription medications at markedly lower rates than do non-Hispanic whites. At the same time, Hispanics are the largest racial-ethnic minority in the USA. In a recent effort to reach this underdeveloped market, the pharmaceutical industry has begun to create Spanish-language direct-to-consumer advertising (DTCA) campaigns. The substantive content of these campaigns is being tailored to appeal to the purported cultural values, beliefs and identities of Latino consumers. We compare English-language and Spanish-language television commercials for two prescription medications. We highlight the importance of selling medicine to a medically under-served population as a key marketing element of Latino-targeted DTCA. We define selling medicine as the pharmaceutical industry's explicit promotion of medicine's cultural authority as a means of expanding its markets and profits. We reflect on the prospects of this development in terms of promoting medicalisation in a US subgroup that has heretofore eluded the pharmaceutical industry's marketing influence. Our analysis draws on Nikolas Rose's insights concerning variations in the degree to which certain groups of people are more medically made up than others, by reflecting on the racial and ethnic character of medicalisation in the USA and the role DTCA plays in shaping medicalisation trends. A video abstract of this article can be found at: https://www.youtube.com/watch?v=ZabCle9-jHw&feature=youtu.be. © 2015 Foundation for the Sociology of Health & Illness.
Murray, Elizabeth; Lo, Bernard; Pollack, Lance; Donelan, Karen; Lee, Ken
The objective of the study was to determine physicians' views of the effects of Direct-to-Consumer Advertising (DTCA) on health service utilization, quality of care, and the doctor-patient relationship. Cross-sectional survey of a nationally representative sample of US physicians to determine their perceptions of the effects of patients discussing information from DTCA on time efficiency; requests for specific interventions; health outcomes; and the doctor-patient relationship. Physicians reported that more than half (56%) of patients who discussed information from DTCA in a visit did so because they wanted a specific intervention, such as a test, change in medication, or specialist referral. The physician deemed 49% of these requests clinically inappropriate. Physicians filled 69% of requests they deemed clinically inappropriate; 39% of physicians perceived DTCA as damaging to the time efficiency of the visit, and 13% saw it as helpful. Thirty-three percent of physicians thought discussing DTCA had improved the doctor-patient relationship; 8% felt it had worsened it. The effect on the relationship was strongly associated with doing what the patient wanted. DTCA can have good and bad effects on quality of care, the doctor-patient relationship, and health service utilization. The benefits might be maximized, and the harms minimized, by increasing the accuracy of information in advertisements; enhancing physicians' communication and negotiation skills; and encouraging patients to respect physicians' clinical expertise.
Abel, G. A.; Neufeld, E. J.; Sorel, M; Weeks, J. C.
OBJECTIVE In the United States, the Food and Drug Administration (FDA) requires that all direct-to-consumer advertising (DTCA) contain both an accurate statement of a medication’s effects (“truth”) and an even-handed discussion of its benefits and risks/adverse effects (“fair balance”). DTCA for medications to treat rare diseases such as bleeding disorders is unlikely to be given high priority for FDA review. METHODS We reviewed all DTCA for bleeding disorder products appearing in the patient-directed magazine HemeAware from January, 2004 to June, 2006. We categorized the information presented in each advertisement as benefit, risk/adverse effect, or neither, and assessed the amount of text and type size devoted to each. We also assessed the readability of each type of text using the Flesch Reading Ease Score (FRES, where a score of ≥ 65 is considered of average readability), and assessed the accuracy of the advertising claims utilizing a panel of five bleeding disorder experts. RESULTS A total of 39 unique advertisements for 12 products were found. On average, approximately twice the amount of text was devoted to benefits as compared to risks/adverse effects, and the later was more difficult to read (FRES of 20.45 for risks/adverse effects versus 32.08 for benefits; difference of 11.56 [95% CI: 4.52, 18.60]). Only about two-thirds of the advertising claims were considered by a majority of the experts to be based on at least low-quality evidence. CONCLUSION As measured by our methods, print DTCA for bleeding disorders may not reach the FDA’s standards of truth and fair balance. PMID:18647231
Abel, G A; Neufeld, E J; Sorel, M; Weeks, J C
In the United States, the Food and Drug Administration (FDA) requires that all direct-to-consumer advertising (DTCA) contain both an accurate statement of a medication's effects ('truth') and an even-handed discussion of its benefits and risks/adverse effects ('fair balance'). DTCA for medications to treat rare diseases such as bleeding disorders is unlikely to be given high priority for FDA review. We reviewed all DTCA for bleeding disorder products appearing in the patient-directed magazine HemeAware from January 2004 to June 2006. We categorized the information presented in each advertisement as benefit, risk/adverse effect, or neither, and assessed the amount of text and type size devoted to each. We also assessed the readability of each type of text using the Flesch Reading Ease Score (FRES, where a score of >or=65 is considered of average readability), and assessed the accuracy of the advertising claims utilizing a panel of five bleeding disorder experts. A total of 39 unique advertisements for 12 products were found. On average, approximately twice the amount of text was devoted to benefits as compared with risks/adverse effects, and the latter was more difficult to read [FRES of 32.0 for benefits vs. 20.5 for risks/adverse effects, a difference of 11.5 (95% CI: 4.5-18.5)]. Only about two-thirds of the advertising claims were considered by a majority of the experts to be based on at least low-quality evidence. As measured by our methods, print DTCA for bleeding disorders may not reach the FDA's standards of truth and fair balance.
This study content analyzed online direct-to-consumer advertisements (DTCA) for prescription drug treatments to explore whether ads for prescription treatments for psychiatric conditions, which are commonly untreated, differ from other drug advertisements. Coded variables included the presence of interactive technological components, use of promotional incentives, and the social contexts portrayed in images shown on each site. Statistical analysis revealed ads for psychiatric medications contained fewer interactive website features, financial incentives, and calls to action than other types of prescription drug advertisements. Implications for health communication researchers are discussed.
Rainone, Nicolette; Oodal, Reshma; Niederdeppe, Jeff
This study tests the effect of pharmaceutical Direct-to-Consumer Advertising (DTCA) for antidepressants on perceived stigma surrounding mental disorders. We randomly assigned participants into one of three experimental conditions: antidepressant DTCA with portrayals of discrimination, cognitive separation, and stereotyping (DCSS), antidepressant DTCA without these representations, or a no-exposure control. Contrary to study hypotheses, participants who viewed ads containing portrayals of DCSS were significantly less likely to want to socially distance themselves from those with mental illnesses than those assigned to the no-exposure control condition, even when controlling for demographics and personal experience with mental illness. We discuss plausible explanations for the unexpected pattern of effects and resulting implications for future research on the topic.
Khanfar, Nile M.; Clauson, Kevin A.; Polen, Hyla H.; Shields, Kelly M.
Background: Direct-to-consumer advertising (DDTCA) of medications, a marketing tool used by the pharmaceutical industry to increase patient awareness of products, affects both consumer behavior and, ultimately, physician prescribing practices. Billions of dollars are budgeted each year for DTCA, and its influence is far-reaching. However, little information is available about patient-initiated physician interactions in which television-bbased DTCA has played a role in consumer behavior.
Kruger, Christopher; Niederdeppe, Jeff; Byrne, Sahara; Avery, Rosemary J
Pharmaceutical direct-to-consumer advertising (DTCA) is widely prevalent on US television. This study tests the relationship between estimated exposure to DTCA for statin drugs, which often feature mixed messages about the efficacy of diet and exercise in reducing risk of cholesterol and heart disease, and guilty feelings regarding food and exercise. A series of repeated cross-sectional surveys of the US population between 2001 and 2007 (N=106,859 adults aged 18 and older) were combined with data on the frequency of DTCA appearances on national, cable, and local television during the same time period. Adjusting for potential confounders with ordinary least squares (OLS) regression, increased potential exposure to statin DTCA was associated with increased food guilt (in a dose-response pattern) and exercise guilt (in a threshold pattern). This study provides new evidence that DTCA has potential to influence emotional well-being as well as direct behavioral responses emphasized in previous academic research. Health practitioners should be prepared to encounter and counsel patients who are prompted by DTCA to feel guilty about their food and exercise behaviors, feelings which may impact the likelihood of adherence to prescribed behavioral modification for weight management. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Tim K. Mackey
The adoption and use of digital forms of direct-to-consumer advertising (also known as "eDTCA") is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing...
Huh, Jisu; DeLorme, Denise E; Reid, Leonard N; An, Soontae
Direct-to-consumer advertising has changed the way prescription drugs are marketed in the United States. This article traces the history of direct-to-consumer advertising of prescription and over-the-counter medications and describes how drug advertising is regulated and by whom. It also discusses the controversies that surround direct-to-consumer marketing of prescription drugs.
Lee, Mina; Whitehill King, Karen; Reid, Leonard N
Using a model developed from the research literature, the authors compared consumers' attitudinal and behavioral responses to direct-to-consumer prescription drug advertising (DCTA) and over-the-counter nonprescription drug advertising (OTCA) of drugs. Adults 18 years of age and older who had taken any prescription drugs in the past 6 months completed online survey questionnaires. Variables measured included demographics (age, gender, race, education, and income), health-related characteristics (health status, prescription and over-the-counter drug use, health consciousness, and involvement with prescription or over-the-counter drugs), perceived amount of attention and exposure to DTCA and OTCA, attitudinal outcomes (skepticism toward DTCA/OTCA and attitude toward DTCA/OTCA), and behavioral outcomes triggered by DTCA and OTCA. The findings indicate that exposure to drug advertising is one of the most significant predictors of attitudinal and behavioral outcomes. Some audience factors such as health status, involvement with drugs, health consciousness, drug use, income, and age also were differentially associated with consumer responses to drug advertising.
Kim, Yoonsang; Kornfield, Rachel; Shi, Yaru; Vera, Lisa; Daubresse, Matthew; Alexander, G Caleb; Emery, Sherry
Televised direct-to-consumer advertising (DTCA) for prescription drugs is controversial, especially for tobacco cessation products such as varenicline, given safety concerns that arose only after its market approval. We aim to quantify the extent to which DTCA influenced varenicline use. We linked monthly DTCA television ratings with monthly prescription data from IMS Health's National Prescription Audit across top 75 media markets in 2006-2009. We used Poisson models with Generalized Estimating Equations to analyze effects of exposures to DTCA for both varenicline and nicotine replacement therapies on rate of dispensed varenicline prescriptions among smokers, controlling for population characteristics and varenicline-related events. Varenicline prescriptions increased dramatically following DTCA launch and declined sharply after safety risks were publicized and US Food and Drug Administration (FDA) issued an advisory. DTCA had significant impact on new prescription dispensing in the subsequent month: before the FDA advisory, one additional exposure to varenicline DTCA was associated with a 1.8% (rate ratio [RR] = 1.018 [1.015-1.021]) higher rate of new prescriptions; no effect was observed after the advisory (RR = 1.000 [0.997-1.003]). Prior to the advisory, cross-product effects of nicotine replacement therapy advertising on varenicline prescribing were negligible (RR = 1.002 [0.999-1.004]); after the advisory, effects were positive (RR = 1.015 [1.012-1.019]). DTCA for varenicline had a significant impact on varenicline prescribing when the drug's safety profile was not well characterized, supporting arguments to limit DTCA for newly approved products whose real-world safety is unclear. We examined the fluctuations in varenicline use in association with DTCA for varenicline and other tobacco cessation aids. To our knowledge this is the first study to quantify the effects of televised DTCA for varenicline and other tobacco cessation aids on varenicline
Prescription drug direct-to-consumer advertising (DTCA) has been a subject of controversy in recent years. Though government regulations require equivalent prominence of risks and benefits, there is concern about the ability of consumers with limited health literacy to fully comprehend the risks and benefits associated with drug use. Evaluating…
Full Text Available Direct-to-consumer advertising (DTCA of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow 'reminder' advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. 'Reminder' advertising is prohibited in the US for drugs that have 'black box' warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising.Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib, which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings.Branded 'reminder' advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for
Mintzes, Barbara; Morgan, Steve; Wright, James M
Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow 'reminder' advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. 'Reminder' advertising is prohibited in the US for drugs that have 'black box' warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising. Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings. Branded 'reminder' advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for compromise
Mintzes, Barbara; Morgan, Steve; Wright, James M.
Background Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow ‘reminder’ advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. ‘Reminder’ advertising is prohibited in the US for drugs that have ‘black box’ warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising. Methodology/Principal Findings Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings. Conclusions/Significance Branded ‘reminder’ advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have
Manika, Danae; Ball, Jennifer G; Stout, Patricia A
This quantitative study explored young women's response to direct-to-consumer pharmaceutical advertising (DTCA) for a human papillomavirus (HPV) vaccine. In particular, the study examined (a) the association of factors stemming from consumer research with actual and intended behavioral responses to DTCA for HPV and (b) key elements drawn from commonly used health-related theories to determine the strongest associations with behavioral intentions regarding the HPV vaccine. Survey findings showed that vaccinated women indicated that DTCA played a role in their decision to get vaccinated against HPV more so than those who were not vaccinated. Trust in DTCA for an HPV vaccine brand was significantly related to intentions to seek more information about the vaccine. Also, perceived barriers had the only significant association with behavioral intentions when taking into account perceived threat and response efficacy. These results provide practical implications for key industry decision makers and health communication professionals on the design of effective theory-based health communication message content for an HPV vaccine brand with consequent social implications.
Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".
Mackey, Tim K
The adoption and use of digital forms of direct-to-consumer advertising (also known as "eDTCA") is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA) notices of violations (NOVs) and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the "disruptive" qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored. © 2016 by Kerman University of Medical Sciences.
Tan, Andy S L
Cancer-related direct-to-consumer advertising (DTCA) is controversial because cancer treatment is complex and entails more risks and costs than typical treatments that are advertised for other conditions. Drawing from the Structural Influence Model of Communication, this study explores communication inequalities in DTCA exposure across social determinants among a population-based sample of 2013 patients diagnosed with breast, prostate, or colorectal cancers. Three survey items assessed patients' frequency of encountering ads concerning treatment alternatives for cancer, dealing with side effects of treatment, and doctors or hospitals offering services for cancer following their diagnosis. The analysis showed that overall exposure to DTCA in this study population was modest (median was once per week). Breast cancer patients reported significantly higher exposure to all three ad categories and overall DTCA exposure than prostate and colorectal cancer patients. Older patients consistently reported lower overall exposure to DTCA across the three cancer types. Other significant correlates included ethnicity (higher exposures among African American prostate cancer patients vs. White; lower exposures in Hispanic colorectal cancer patients vs. White) and cancer stage (higher exposures in Stage IV prostate cancer patients vs. Stages 0-II). Education level did not predict patients' DTCA exposure. The implications of these observed inequalities in DTCA exposure on cancer outcomes are discussed.
Layton, J Bradley; Kim, Yoonsang; Alexander, G Caleb; Emery, Sherry L
Testosterone initiation increased substantially in the United States from 2000 to 2013, especially among men without clear indications. Direct-to-consumer advertising (DTCA) also increased during this time. To investigate associations between televised DTCA and testosterone testing and initiation in the United States. Ecologic study conducted in designated market areas (DMAs) in the United States. Monthly testosterone advertising ratings were linked to DMA-level testosterone use data from 2009-2013 derived from commercial insurance claims. Associations between DTCA and testosterone testing, initiation, and initiation without recent baseline tests were estimated using Poisson generalized estimating equations. Monthly Nielsen ratings for testosterone DTCA in the 75 largest DMAs. (1) Rates of new serum testosterone testing; (2) rates of testosterone initiation (in-office injection, surgical implant, or pharmacy dispensing) for all testosterone products combined and for specific brands; and (3) rates of testosterone initiation without recent serum testosterone testing. Of 17 228 599 commercially insured men in the 75 DMAs, 1 007 990 (mean age, 49.6 [SD, 11.5] years) had new serum testosterone tests and 283 317 (mean age, 51.8 [SD, 11.3] years) initiated testosterone treatment. Advertising intensity varied by geographic region and time, with the highest intensity seen in the southeastern United States and with months ranging from no ad exposures to a mean of 13.6 exposures per household. Nonbranded advertisements were common prior to 2012, with branded advertisements becoming more common during and after 2012. Each household advertisement exposure was associated with a monthly increase in rates of new testosterone testing (rate ratio [RR], 1.006; 95% CI, 1.004-1.008), initiation (RR, 1.007; 95% CI, 1.004-1.010), and initiation without a recent test (RR, 1.008; 95% CI, 1.002-1.013). Mean absolute rate increases were 0.14 tests (95% CI, 0.09-0.19), 0.05 new
Mintzes, Barbara; Mangin, Dee
Direct-to-consumer advertising of prescription-only medicines is currently only permitted in the USA and New Zealand. Barbara Mintzes and Dee Mangin provide their case against direct-to-consumer advertising of prescription medicines, arguing that its wider introduction would lead to a 'Pharma-knows-best' culture.
Winston, Clifford; Calfee, John E.; Stempski, Randolph
In August 1997, the Food and Drug Administration (FDA) reinterpreted its advertising regulations to ease limits on the use of broadcast media when advertising prescription drugs directly to consumers. We estimate the effect of direct-to-consumer advertising on demand, using 1995-2000 data from the market for the statin class of cholesterol-reducing drugs. We find no statistically significant effect from any form of advertising and promotion on new statin prescriptions or renewals and no evide...
Still the Great Debate - "Fair Balance" in Direct-to-Consumer Prescription Drug Advertising Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".
Rollins, Brent L
The above titled paper examined the Food and Drug Administration's (FDA's) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing? © 2016 by Kerman University of Medical Sciences.
Still the Great Debate – “Fair Balance” in Direct-to-Consumer Prescription Drug Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Brent L. Rollins
Full Text Available The above titled paper examined the Food and Drug Administration’s (FDA’s warning letters and notice of violations (NOV over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing?
Congressional Budget Office
Concerns about direct-to-consumer advertising of prescription drugs have spurred recent proposals for a moratorium on advertising brand-name prescription drugs to consumers during the first two years following a drug's approval by the Food and Drug Administration. This Congressional Budget Office brief examines some of the effects of such a moratorium, drawing on data documenting direct-to-consumer advertising and other promotional activities used by pharmaceutical producers as well as academ...
Hall, Danika V; Jones, Sandra C
This study aimed to elicit and compare the responses of Australian consumers towards New Zealand (NZ) direct-to-consumer-advertisements (DTCA) for prescription medicines and matched pharmaceutical company-sponsored advertisements from Australia. A survey questionnaire was mailed to a random sample of residents in a metropolitan area in NSW. Potential participants were randomised to receive one of four different advertisements: two for weight loss and two for Alzheimer's disease. A total of 413 responses were received and analysed. Participants reported that they were not likely to ask for a prescription from their doctor as a result of seeing any of the advertisements in the study. The Australian disease awareness advertisement that did not refer to a medicinal treatment was perceived as more valuable than the NZ DTCA or other Australian advertisement. Overall, participants found it easier to make sense of the more informational advertisements, and felt that there was insufficient information regarding the disease/condition and treatments in the more emotive and transformational advertisements. While there is concern over potential negative effects of pharmaceutical-sponsored disease awareness advertisements, this study found that Australian consumers perceived an informational advertisement with a list of disease symptoms to be valuable. These findings contribute to debate in New Zealand and Australia regarding DTCA and disease awareness advertising, and have the potential to inform guidelines relevant to the advertising of prescription medicine in each country.
Dens, Nathalie; Eagle, Lynne C; De Pelsmacker, Patrick
Patients', doctors', and pharmacists' attitudes toward direct-to-consumer advertising (DTCA) for medication and their perceptions of its impact on patient self-reported behavior in terms of request for, and consumption of, advertised medication were investigated. Data were obtained in New Zealand, 1 of only 2 countries that allow mass-media DTCA for prescription medication, and in Belgium, which does not. Attitudes were relatively negative in both countries, but significantly more positive in New Zealand than in Belgium. The impact of DTCA (both in a positive and a negative sense) on self-reported patient behavior and patient interaction with doctors and pharmacists was limited in both countries. Although -- as already established in previous work -- the informativeness and reliability of DTCA can be much improved, and the attitude of medical professionals toward DTCA is negative in both countries, from the point of view of medical professionals and patients, DTCA does not harm the self-reported relationship between doctors, pharmacists, and patients.
Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Tim K. Mackey
Full Text Available The adoption and use of digital forms of direct-to-consumer advertising (also known as “eDTCA” is on the rise. At the same time, the universe of eDTCA is expanding, as technology on Internet-based platforms continues to evolve, from static websites, to social media, and nearly ubiquitous use of mobile devices. However, little is known about how this unique form of pharmaceutical marketing impacts consumer behavior, public health, and overall healthcare utilization. The study by Kim analyzing US Food and Drug Administration (FDA notices of violations (NOVs and warning letters regarding online promotional activities takes us in the right direction, but study results raise as many questions as it does answers. Chief among these are unanswered concerns about the unique regulatory challenges posed by the “disruptive” qualities of eDTCA, and whether regulators have sufficient resources and oversight powers to proactively address potential violations. Further, the globalization of eDTCA via borderless Internet-based technologies raises larger concerns about the potential global impact of this form of health marketing unique to only the United States and New Zealand. Collectively, these challenges make it unlikely that regulatory science will be able to keep apace with the continued rapid evolution of eDTCA unless more creative policy solutions are explored.
Wood, Kelly S; Cronley, Maria L
This study examines changes over a 10-year period in consumer reports of communication with health care providers about direct-to-consumer advertised (DTCA) medications. Two rounds of survey data were collected in 2003 and 2012 using repeated cross-sectional procedures to examine consumer willingness to discuss DTCA medications, content and tone of those conversations, and attitudes about the advertisements. In total, 472 surveys were analyzed. Generally, we found physician-patient conversations, attitudes, and behaviors regarding DTCA have changed. Consumers in 2012 reported talking significantly less about the names of the advertised drug, comparing the advertised drug with their current medication, and sharing general information than consumers in 2003. Attitudes toward the advertisements were significantly more negative in 2012 compared to 2003. Of those who specifically asked for a prescription, the proportion of patients who received the prescription was significantly lower in 2012, despite research suggesting increased rates of prescriptions. These results are interpreted in light of previous research about the lack of research examining the actual communication between physicians and patients on this topic. Limitations of the study are provided along with directions for future research about DTCA and physician-patient communication.
Gilbody, S; Wilson, P; Watt, I
Direct to consumer advertising is increasingly used by the pharmaceutical industry, but its benefits and harms have yet to be summarised in a comprehensive and rigorous manner. A systematic review was conducted of robust evaluations of the impact (positive and negative) of direct to consumer advertising. A broad range of databases and data sources (including Cinahl, Embase, HMIC, HSRProj, Medline, PsycInfo, and the internet) were searched from inception to 2004. From 2853 citations only four reports were found that met the strict inclusion criteria and provided usable results. Direct to consumer advertising is associated with increased prescription of advertised products and there is substantial impact on patients' request for specific drugs and physicians' confidence in prescribing. No additional benefits in terms of health outcomes were demonstrated. Direct to consumer advertising is banned in most countries, and the research evidence tends to support the negative impact that is feared by those who support a legislative ban. Further research is needed into the clinical and economic impact of direct to consumer advertising in healthcare systems.
Donohue, Julie M; Cevasco, Marisa; Rosenthal, Meredith B
Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert underuse of medicines and leads to potential overuse. Concern about such advertising has increased recently owing to the withdrawal from the market of heavily advertised drugs found to carry serious risks. Moreover, the Food and Drug Administration (FDA) has been criticized for its weak enforcement of laws regulating such advertising. We examined industry-wide trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotion to physicians during the past decade. We characterized the drugs for which such advertising is used and assessed the timing of advertising after a drug is introduced. Finally, we examined trends in the FDA's regulation of drug advertising. Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006. Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it. Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices. Copyright 2007 Massachusetts Medical Society.
Alperstein, Neil M
This study examines awareness and knowledge of and attitudes toward direct-to-consumer (DTC) prescription drug advertising among young adults between 18 and 24 years of age. The study finds that young adults are not as aware of prescription drug advertising as older consumers, however, they are aware of specific heavily advertised drugs, especially those for allergy medications, birth control, and sleep aids. Young adults hold mixed to negative views about advertising in general, and they do not view DTC prescription drug advertising as a beneficial source of information, nor do they believe such advertising serves to educate consumers.
Kiernicki, Kristen; Helme, Donald W
Although direct-to-consumer (DTC) prescription drug advertising is regulated by the U.S. Food and Drug Administration, content analyses suggest advertisers may not disclose drug risks in the same way they describe drug benefits. This study tests the relationship between image congruency in televised DTC advertisements, recall of risks/benefits, and perceived persuasiveness. Advertisements for Nasonex, Advair, and Lunesta were shown to college students in either their original (image incongruent) or modified (image neutral) form. Risks were easier to recall with image-neutral advertisements. Gender also had a significant interaction effect, suggesting that males and females process DTC advertisement differently.
Bradford, W David; Kleit, Andrew N; Nietert, Paul J; Steyer, Terrence; McIlwain, Thomas; Ornstein, Steven
Concern about the potential pernicious effect of direct-to-consumer (DTC) drug advertising on physicians' prescribing patterns was heightened with the 2004 withdrawal of Vioxx, a heavily advertised treatment for osteoarthritis. We examine how DTC advertising has affected physicians' prescribing behavior for osteoarthritis patients. We analyzed monthly clinical information on fifty-seven primary care practices during 2000-2002, matched to monthly brand-specific advertising data for local and network television. DTC advertising of Vioxx and Celebrex increased the number of osteoarthritis patients seen by physicians each month. DTC advertising of Vioxx increased the likelihood that patients received both Vioxx and Celebrex, but Celebrex ads only affected Vioxx use.
Murray, Elizabeth; Lo, Bernard; Pollack, Lance; Donelan, Karen; Lee, Ken
To determine public perceptions of the effect of direct-to-consumer advertising (DTCA) of prescription medications on health behaviors, health care utilization, the doctor-patient relationship, and the association between socioeconomic status and these effects. Cross-sectional survey of randomly selected, nationally representative sample of the US public using computer-assisted telephone interviewing. numbers and proportions of respondents in the past 12 months who, as a result of DTCA, requested preventive care or scheduled a physician visit; were diagnosed with condition mentioned in advertisement; disclosed health concerns to a doctor; felt enhanced confidence or sense of control; perceived an effect on the doctor-patient relationship; requested a test, medication change, or specialist referral; or manifested serious dissatisfaction after a visit to a doctor. As a result of DTCA, 14% of respondents disclosed health concerns to a physician, 6% requested preventive care, 5% felt more in control during a physician visit; 5% made requests for a test, medication change, or specialist referral, and 3% received the requested intervention. One percent of patients reported negative outcomes, including worsened treatment, serious dissatisfaction with the visit, or that the physician acted challenged. Effects of DTCA were greater for respondents with low socioeconomic status. DTCA has positive and negative effects on health behaviors, health service utilization, and the doctor-patient relationship that are greatest on people of low socioeconomic status. The benefits of DTCA in terms of encouraging hard-to-reach sections of the population to seek preventive care must be balanced against increased health care costs caused by clinically inappropriate requests generated by DTCA.
Arnold, Denis G; Oakley, James L
As the pharmaceutical industry lobbies European regulators to permit direct-to-consumer advertising (DTCA) of prescription drugs in the European Union, we found that five leading companies violated industry-developed and -promulgated standards for ethical advertising in the United States. Utilizing multiple data sources and methods, we demonstrate a consistent failure by companies that market erectile dysfunction drugs to comply with the industry's guiding principles for ethical DTCA over a four-year period despite pledges of compliance by company leaders. Noncompliance resulted in children being exposed to sexually themed promotional messages more than 100 billion times. We argue that the guidelines are a coordinated effort by the industry to prevent unwanted federal regulation, and we introduce the concept of a blocking strategy to explain company behavior and to advance theoretical understanding of firms' public affairs strategies. We recommend policy responses to prevent deceptive practices, protect children from adult content, and promote genuine health care education.
Background The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. Objective This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. Methods A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug’s risks and side effects or of a “major statement” identifying the drug’s major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of “fair balance,” the FDA’s requirement that prescription drug ads balance information relating to the drug’s risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Results Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug’s risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and
The current direct-to-consumer advertising (DTCA) guidelines were developed with print, television, and radio media in mind, and there are no specific guidelines for online banner advertisements. This study evaluates how well Internet banner ads comply with existing Food and Drug Administration (FDA) guidelines for DTCA in other media. A content analysis was performed of 68 banner advertisements. A coding sheet was developed based on (1) FDA guidance documents for consumer-directed prescription drug advertisements and (2) previous DTCA content analyses. Specifically, the presence of a brief summary detailing the drug's risks and side effects or of a "major statement" identifying the drug's major risks, and the number and type of provisions made available to consumers for comprehensive information about the drug were coded. In addition, the criterion of "fair balance," the FDA's requirement that prescription drug ads balance information relating to the drug's risks with information relating to its benefits, was measured by numbering the benefit and risk facts identified in the ads and by examining the presentation of risk and benefit information. Every ad in the sample included a brief summary of risk information and at least one form of adequate provision as required by the FDA for broadcast ads that do not give audiences a brief summary of a drug's risks. No ads included a major statement. There were approximately 7.18 risk facts for every benefit fact. Most of the risks (98.85%, 1292/1307) were presented in the scroll portion of the ad, whereas most of the benefits (66.5%, 121/182) were presented in the main part of the ad. Out of 1307 risk facts, 1292 were qualitative and 15 were quantitative. Out of 182 benefit facts, 181 were qualitative and 1 was quantitative. The majority of ads showed neutral images during the disclosure of benefit and risk facts. Only 9% (6/68) of the ads displayed positive images and none displayed negative images when presenting risks
Becker, Sara J; Midoun, Miriam M
To systematically analyze the effects of direct-to-consumer advertising (DTCA) on patient requests for medication and physician prescribing across psychiatry-relevant studies. MEDLINE, PsycINFO, Thomson Reuters' ISI Web of Knowledge, and Google Scholar were searched (1999-2014) using variations of the terms direct-to-consumer advertising and psychiatric. Reference lists and an online repository of DTCA manuscripts were also scrutinized. English-language studies collecting data at the point of service, focusing on or including psychiatric medication, and assessing the effects of DTCA on patient and/or physician behavior were included. Of 989 articles identified, 69 received full-text review. Four studies across 5 manuscripts met inclusion criteria. Data were extracted on participants, study design, methodological quality, and results. Methodological quality of individual studies was assessed using adapted criteria from the Effective Public Health Practice Project. Confidence in conclusions across studies was determined using principles from the well-established GRADE system. Due to lack of replication across strong randomized controlled trials (RCTs), no conclusions merited high confidence. With moderate confidence, we concluded that DTCA requests (1) are granted most of the time (1 RCT, 3 observational), (2) prompt higher prescribing volume (1 RCT, 1 observational), (3) promote greater adherence to minimally acceptable treatment guidelines for patients with depression (1 RCT), and (4) stimulate overprescribing among patients with an adjustment disorder (1 RCT). Findings suggest that DTCA requests are typically accommodated, promote higher prescribing volume, and have competing effects on treatment quality. More methodologically strong studies are needed to increase confidence in conclusions. © Copyright 2016 Physicians Postgraduate Press, Inc.
Tan, Andy S L
Spillover effects of exposure to direct-to-consumer advertising (DTCA) of cancer treatments on patients' general inquiry about their treatments and managing their illness are not well understood. This study examines the effects of cancer patients' exposure to cancer-related DTCA on subsequent health information seeking behaviors from clinician and non-clinician sources (lay media and interpersonal contacts). Using a longitudinal survey design over 3 years, data was collected from cancer survivors diagnosed with colorectal, breast, or prostate cancer who were randomly sampled from the Pennsylvania Cancer Registry. Study outcome measures include patients' information engagement with their clinicians and information seeking from non-medical sources about cancer treatment and quality of life issues, measured in the second survey. The predictor variable is the frequency of exposure to cancer-related DTCA since diagnosis, measured at the round 1 survey. The analyses utilized lagged-weighted multivariate regressions and adjusted for round 1 levels of patient-clinician engagement, information seeking from nonmedical sources, and confounders. Exposure to cancer-related DTCA is associated with increased levels of subsequent patient-clinician information engagement (B = .023, 95% CI = .005-.040, p = .012), controlling for confounders. In comparison, exposure to DTCA is marginally significant in predicting health information seeking from non-clinician sources (B = .009, 95% CI = -.001-.018, p = .067). Cancer-related DTCA has potentially beneficial spillover effects on health information seeking behaviors among cancer patients. Exposure to DTCA predicts (a little) more patient engagement with their physicians.
Tan, Andy SL
Spillover effects of exposure to direct-to-consumer advertising (DTCA) of cancer treatments on patients’ general inquiry about their treatments and managing their illness are not well understood. This study examines the effects of cancer patients’ exposure to cancer-related DTCA on subsequent health information seeking behaviors from clinician and non-clinician sources (lay media and interpersonal contacts). Using a longitudinal survey design over three years, data was collected from cancer survivors diagnosed with colorectal, breast, or prostate cancer who were randomly sampled from the Pennsylvania Cancer Registry. Study outcome measures include patients’ information engagement with their clinicians and information seeking from non-medical sources about cancer treatment and quality of life issues, measured in the second survey. The predictor variable is the frequency of exposure to cancer-related DTCA since diagnosis, measured at the round 1 survey. The analyses utilized lagged weighted multivariate regressions and adjusted for round 1 levels of patient-clinician engagement, information seeking from non-medical sources, and confounders. Exposure to cancer-related DTCA is associated with increased levels of subsequent patient-clinician information engagement (B=.023, 95%CI=.005 to .040, p=.012), controlling for confounders. In comparison, exposure to DTCA is marginally significant in predicting health information seeking from non-clinician sources (B=.009, 95%CI=−.001 to .018, p=.067). Cancer-related DTCA has potentially beneficial spillover effects on health information seeking behaviors among cancer patients. Exposure to DTCA predicts (a little) more patient engagement with their physicians. PMID:24254248
Mackert, Michael; Love, Brad
Direct-to-consumer (DTC) pharmaceutical advertisements have been analyzed in many ways, but richer conceptualizations of health literacy have been largely absent from this research. With approximately half of U.S. adults struggling to understand health information, it is important to consider consumers' health literacy when analyzing DTC advertisements. This project, framed by the health belief model, analyzed 82 advertisements. Advertisements provided some kinds of educational content (e.g., drugs' medical benefits) but typically failed to offer other useful information (e.g., other strategies for dealing with conditions). Issues likely to be barriers to low health literate consumers, such as nonstandard text formatting, are common.
Spake, Deborah F; Joseph, Mathew; Megehee, Carol M
This study explores the connection between perceptions of direct-to-consumer (DTC) advertising based on where people live and shop. Urban consumers were found to be more skeptical of DTC advertising, but more likely to believe that physicians select pharmaceuticals based on the efficacy of the product. Those living in rural areas were more motivated to visit a doctor and more likely to feel an equal doctor-patient relationship after exposure to DTC advertising. Interaction effects among gender, income, and education were detected, as well as an interaction effects between location and income on views of DTC advertising.
Martinez, Lourdes S; Lewis, Nehama
This study investigated the impact of exposure to prescription drug advertisements for antidepressants and antianxiety medications on public opinion regarding preferred treatment options for youth suffering from depression or anxiety. The study randomly recruited a nationally representative adult sample (N = 402) through the 2007 Annenberg National Health Communication Survey. The study examined the distribution of public support for the use of antidepressant drugs to treat depression and anxiety disorders in youth. The analysis adjusted for the effects of demographic characteristics, prior knowledge about prescription drugs, and personal and familial drug history. Attitude toward direct-to-consumer advertising (DTCA, for all products) moderated the effect of exposure to ads for these drug treatments on support for their use among youth as a preferred treatment. Among respondents with negative attitude toward direct-to-consumer advertising (for all products), with increased exposure to ads for antidepressants and antianxiety medications, support for the use of these drugs to treat youth decreased. Among this group, with high levels of exposure to advertisements, the predicted probability of support decreased from 0.68 (95% CI: 0.61 to 0.76) to 0.46 (95% CI: 0.38 to 0.56). No effect was found among respondents with positive attitudes toward DTCA (for all products). The implications of the findings are discussed.
Avery, Rosemary J; Eisenberg, Matthew; Simon, Kosali I
The authors evaluated fair balance in the presentation of risks and benefits in a large sample of direct-to-consumer advertising for prescription antidepressant medications appearing in magazines (1995-2006) and television (1999-2007) to assess how well they meet U.S. Food and Drug Administration guidelines. Using content analysis to capture relevant dimensions of the ads, results indicated that (a) considerably less attention is given to risks relative to benefits and (b) implicit ad content favors communication of drug benefits over risks, but that fair balance in direct-to-consumer ads has improved over time. The authors discuss policy implications and explore future research directions.
Fogel, Joshua; Novick, Daniel
This study sought data on the impact of direct-to-consumer (DTC) advertisements and both intentions and frequency to seek more information about the drug being advertised. Data were collected from 498 college students regarding intention to seek and how frequently they obtained more information about prescription medications. For intentions, grocery or pharmacy and radio advertisements were associated with lesser intentions. For frequency, Internet advertisements were associated, while newspaper and spam e-mail advertisements were not. Types of sources associated with seeking additional information were doctor, Internet, and 1-800 information numbers. A significant interaction existed for seeing Internet advertisements for drugs and then seeking additional information from a doctor and not from the Internet. In conclusion, Internet advertising is associated with seeking additional information from a reliable source such as a doctor.
Direct-to-consumer (DTC) advertising saturates popular health magazines, communicating persuasive messages to readers that may influence attitudes and behaviors. This research used a two-prong approach to investigate the visual elements used in DTC advertising and their influence on consumers' understanding of a disease and its treatment options. An analysis was conducted of DTC advertisements (N = 62) from a population sample of Arthritis Today magazine, 2000-2010. Three panels of people with arthritis were used to validate the findings and discuss implications for health literacy. Pharmaceutical companies have an opportunity to communicate tailored messages to readers of niche publications and improve disease management.
Calfee, John E
Two papers, by Joel Weissman and colleagues and by Robert Dubois, add to our limited knowledge of the effects of direct-to-consumer (DTC) advertising of prescription drugs. Their results reinforce the largely positive findings from consumer surveys, while adding valuable new data and insights. These suggest that DTC ads probably improve patients' health outcomes and do not tend to lead to inappropriate prescribing. DTC advertising is emerging as a positive force in health care markets, consistent with what is known about the effects of advertising in many other markets.
Viale, Pamela Hallquist
To describe the marketing strategies of direct-to-consumer (DTC) advertising and the risks, benefits, and potential influence on the prescribing practices of nurse practitioners (NPs). Journal articles, media sources, and clinical experience. The effect of DTC advertising of prescription medications on NPs has not been well studied. Although there are studies that examine the effects of DTC advertising on physician prescribing as well as the effects of this practice on the consumer, opinions on the benefits of DTC advertising are varied. NPs need to recognize the potential influence of DTC advertising and to be prepared to guide patients toward appropriate medication choices by participating in a partnership with patients. Health care providers, including NPs, need to work with the pharmaceutical industry to encourage accountability of DTC advertising, thus improving dissemination of correct information and promoting positive outcomes for health consumers and patients.
Taylor, Laramie D; Bell, Robert A; Kravitz, Richard L
This study examines the evidence for a third- person effect (TPE) in the reactions of individuals affected by depression to direct-to-consumer (DTC) advertisements for antidepressants. TPE predicts that people will perceive the self to be less vulnerable to such advertisements than others. Previous research has identified such an effect, but did so in general population surveys. Past Previous research has also found a link between depression and diminished self-serving biases; whether this would be the case for TPE is unknown. An online questionnaire was administered to 148 participants in an Internet depression support group to investigate their perceptions of the influence of direct-to-consumer (DTC) advertisements for antidepressants. Consistent with expectations derived from third-person effect TPE research, participants, although relatively neutral in their attitudes toward such advertisements, nevertheless perceived other individuals with depression as more influenced than themselves. Positive attitudes towards DTC advertisements and depressive symptoms at the time of the survey were each negatively associated with this third-person perception (TPE). Individuals who have been diagnosed with depression and who participated in an online depression support group believe that they are less vulnerable to the influence of DTC advertisements than the typical person with a history of depression. This is moderated by attitudes towards DTC advertisements as well as by depressive symptoms, each of which is associated with a weakened TPE. © 2010 Wiley-Liss, Inc.
Niederdeppe, Jeff; Avery, Rosemary J; Kellogg, Maxwell D; Mathios, Alan
This study examines whether exposure to direct-to-consumer advertising (DTCAs) for statin drugs is associated with non-pharmaceutical behaviors to prevent cardiovascular disease. We focus on the relationship between statin drug DTCA exposure and the frequency of (a) visits to fast-food restaurants and (b) exercise. We combine data on the televised broadcast availability of statin drug DTCAs in large media markets in the United States with 18 waves of the Simmons National Consumer Survey (NCS; n = 120, 229) from 2001 to 2009. We find that statin drug DTCA exposure is associated, in a dose-response pattern, with modest increases in the frequency of exercise and large increases in the frequency of fast-food-restaurant visits. The relationship between statin DTCA exposure and fast-food-restaurant visits were largely consistent in direction but differed in magnitude between those without a previous diagnosis of high cholesterol and those treating high cholesterol with a statin. We conclude with a discussion of the implications of these results for future research on pharmaceutical DTCA and population health.
Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza
The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.
A recent addition to the debate about the benefits and harms of direct-to-consumer (DTC) advertising of medicines and pharmaceuticals is a growing critique of DTC marketing and sale of genetic tests. Academic and policy literatures exploring this issue have, however, tended to focus on the sale of genetic tests, paying rather less attention to the particular implications of advertising. The globalization of broadcast media and ever increasing access to the Internet mean that public exposure to advertising for medical technologies is a reality that national regulatory bodies will be hard pressed to constrain. Working through a case study detailing Myriad Genetics' 2002 pilot advertising campaign for their BRACAnalysis genetic susceptibility test for hereditary breast and ovarian cancer, this paper highlights some of the diverse and often overlooked and unregulated approaches to DTC advertising, and the associated social, ethical and policy implications.
Frosch, Dominick L; May, Suepattra G; Tietbohl, Caroline; Pagán, José A
Direct-to-consumer advertising (DTCA) of prescription drugs is the most common form of health communication Americans are exposed to. The effects of DTCA on prescription requests and utilization are well established, but little is known about the effects of advertisements on health behaviors. Many advertisements, especially those promoting drugs to prevent or treat cardiovascular disease, refer to lifestyle change as a way to improve health. However, no studies have examined how consumers interpret these frequently ambiguous messages. We used in-depth interviews with 45 participants, recruited in Los Angeles, USA between April 2007 and July 2008, to explore perceptions of 5 advertisements for drugs that prevent or treat cardiovascular disease (Lipitor(®), Vytorin(®), Zetia(®), Caduet(®), Plavix(®)). We found that participants interpreted advertising messages within their own life context and identified four trajectories for enacting behavior change versus taking prescription drugs: Negotiators, Avoiders, Embracers and Jumpstarters. Underlying these four typologies were beliefs about whether lifestyle change was something an individual could do or was willing to do. Our results also show how an advertisement narrative could potentially shift perceptions of causality by suggesting that high cholesterol is primarily hereditary, thereby obviating the need for lifestyle change. Some participants stated that they would prefer lifestyle change to a particular prescription drug, but felt that others would be more likely to embrace taking a prescription drug. This "Third Person Effect" may be masking participants' intentions by identifying a more socially desirable route to therapeutic change. These findings raise questions about how the typologies are distributed in the population and how advertising may shift consumers' beliefs over time, thereby contributing to new forms of medicalization. Effective regulation of DTCA may require expanding scrutiny beyond the
Skeldon, Sean C; Kozhimannil, Katy B; Majumdar, Sumit R; Law, Michael R
Direct-to-consumer advertising (DTCA) remains a controversial issue, with concerns that it leads to unnecessary and inappropriate prescribing. Whether DTCA shifts prescribing from first-line (guideline-recommended) therapy to second-line drugs has not been studied. The purpose of this study was to determine the impact of sequential DTCA campaigns for two drugs used to treat benign prostatic hyperplasia (BPH): one newer agent, dutasteride (Avodart(®)), and one older first-line agent, tamsulosin (Flomax(®)). Interrupted time series analysis was used to assess the impact of each DTCA campaign using data on consumer "response" from Google Trends and dispensed prescriptions from IMS Health. We analyzed data for the United States from January 2003 to December 2007. DTCA for dutasteride and tamsulosin commenced on July, 2005 and April, 2006, respectively. Monthly Internet search volume (scaled from 0 to 100) for the advertised trade name of each drug and monthly U.S. prescription rates per 1,000 population were analyzed. The dutasteride campaign was associated with an increase in Internet searches for both "Avodart" (level change +31.3 %, 95 % CI: 27.2-35.4) and "Flomax" (level change +8.3 %, 95 % CI: 0.9-15.7), whereas the tamsulosin campaign was associated with increased "Flomax" searches (level change +25.3 %, 95 % CI: 18.7-31.8). The dutasteride campaign was associated with an increase in the prescription of dutasteride (trend = 0.45/month, 95 % CI: 0.33-0.56), but a larger impact was observed with tamsulosin prescriptions (trend = 0.76/month, 95 % CI: 0.02-1.50). Similarly, the tamsulosin campaign was associated with an immediate fourfold increase in the prescribing of tamsulosin (level change +5.76 units, 95 % CI: 1.79-9.72) compared to dutasteride (level change +1.47 units, 95 % CI: 0.79-2.14). DTCA was associated with the utilization of drugs to treat symptomatic BPH. However, both campaigns were associated with greater increases in the use of the guideline
Bhutada, Nilesh S; Rollins, Brent L
To assess the relationship between disease-specific direct-to-consumer (DTC) advertising, via traditional advertising effectiveness measures, and consumers' self-reported medication-taking behavior. Data were gathered for 514 respondents (age 18 and above) using an online survey panel. Participants were exposed to a disease-specific (i.e., nonbranded) DTC advertising for depression. The advertising stimulus created for the study was based on the Food and Drug Administration guidelines for disease-specific DTC advertising and modeled after current print disease-specific DTC advertising. Participants reviewed the advertising stimulus through the online program and then responded to a questionnaire containing closed-ended questions assessing the constructs. Data were analyzed using chi-square tests. All tests were interpreted at an a priori alpha of 0.05. Significantly more respondents who were highly involved, paid more attention to the advertisement, and were responsive to DTC advertisements in the past indicated that the disease-specific DTC advertising stimulus reminded them to take their depression and other medications. These exploratory results show disease-specific DTC advertising can help people remember to take their prescription medication when viewed, which may lead to more positive medication-taking behavior and increased medication adherence. Additionally, given the fair balance and legal issues surrounding product-specific DTC advertising, disease-specific DTC advertising can serve as an effective component of the marketing mix for pharmaceutical manufacturers. Future research should attempt to study the impact of disease-specific DTC advertising on consumers' actual medication adherence using standardized adherence measures such as prescription records.
Hansen, Richard A; Droege, Marcus
Numerous studies have focused on the impact of direct-to-consumer (DTC) prescription drug advertising on consumer behavior and health outcomes. These studies have used various approaches to assess exposure to prescription drug advertising and to measure the subsequent effects of such advertisements. The objectives of this article are to (1) discuss measurement challenges involved in DTC advertising research, (2) summarize measurement approaches commonly identified in the literature, and (3) discuss contamination, time to action, and endogeneity as specific problems in measurement design and application. We conducted a review of the professional literature to identify illustrative approaches to advertising measurement. Specifically, our review of the literature focused on measurement of DTC advertising exposure and effect. We used the hierarchy-of-effects model to guide our discussion of processing and communication effects. Other effects were characterized as target audience action, sales, market share, and profit. Overall, existing studies have used a variety of approaches to measure advertising exposure and effect, yet the ability of measures to produce a valid and reliable understanding of the effects of DTC advertising can be improved. Our review provides a framework for conceptualizing DTC measurement, and can be used to identify gaps in the literature not sufficiently addressed by existing measures. Researchers should continue to explore correlations between exposure and effect of DTC advertising, but are obliged to improve and validate measurement in this area.
...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29, 2010 (75 FR 15376), to establish standards that would be considered in determining whether the major statement in direct-to-consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. FDA is announcing that it has added a document to the docket for the proposed rulemaking concerning a study entitled: ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to- Consumer Prescription Drug Television Advertisements'' (Distraction Study). This study was designed to investigate some advertising factors that could influence consumers' understanding of a drug's risks. This document reopens the comment period for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards.
Maya B. Mathur
Full Text Available Background: Direct-to-consumer (DTC prescription drug advertisements are thought to induce boomerang effects, meaning they reduce the perceived effectiveness of the alternative option: non-pharmaceutical treatment via lifestyle change. Past research has observed such effects using artificially created, text-only advertisements that may not adequate capture the complex, conflicting portrayal of lifestyle change in real television advertisements. Research in other risk domains has found that individual problem status often moderates boomerang effects, such that subjects who currently engage in the risky behavior exhibit the strongest boomerang effects. Objectives: We aimed to assess whether priming with real direct-to-consumer (DTC television advertisements elicited boomerang effects on perceptions of lifestyle change and whether these effects, if present, were moderated by individual problem status. Methods: We assembled a sample of real, previously aired DTC television advertisements in order to naturalistically capture the portrayal of lifestyle change in real advertisements. We randomized 819 adults in the United States recruited via Amazon Mechanical Turk to view or not view an advertisement for a prescription drug. We further randomized subjects to judge either lifestyle change or drugs on three measures: general effectiveness, disease severity for a hypothetical patient, and personal intention to use the intervention if diagnosed with the target health condition. Results: Advertisement exposure induced a statistically significant, but weak, boomerang effect on general effectiveness (p = 0.01, partial R2 = 0.007 and did not affect disease severity score (p = 0.32, partial R2 = 0.0009. Advertisement exposure elicited a reverse boomerang effect of similar effect size on personal intentions, such that advertisement-exposed subjects reported comparatively higher intentions to use lifestyle change relative to drugs (p = 0.006, partial R2 = 0
Liu, Yifei; Farris, Karen B; Doucette, William R
The objective of this study was to investigate appraisal of means (ie, self-efficacy, outcome expectancy, and affect) in predicting patients' goal-directed behaviors of direct-to-consumer advertising (DTCA)-prompted drug-information search from physicians and the internet. One thousand patients were randomly selected from a nationwide sample frame of 3000 osteoarthritis patients. A self-administered survey assessed exposure to DTCA, drug-information search as goal, self-efficacy, outcome expectancy, affect, and osteoarthritis pain. After 6 weeks, another survey measured the behavior of drug-information search for respondents to the first survey. Study subjects were those who were exposed to DTCA in the previous month, and who set drug-information search as their goal. For each information source, a multiple regression analysis was conducted in which drug-information search was the dependent variable, and self-efficacy, outcome expectancy, affect, and osteoarthritis pain were the independent variables. Among 454 patients who were exposed to DTCA, 174 patients set drug-information search as their goal and were the study subjects. The regression for physicians was not statistically significant. The regression for the internet was significant, accounting for 15% of behavior variance. Self-efficacy was a strong predictor of goal-directed drug-information search from the internet. Appraisal of means was useful to predict the goal-directed behavior of DTCA-prompted drug-information search from the internet. For patients who set drug-information search as a goal, actions to promote drug-information search from the internet need to focus on self-efficacy.
Khanfar, Nile M; Clauson, Kevin A; Polen, Hyla H; Shields, Kelly M
Direct-to-consumer advertising (DDTCA) of medications, a marketing tool used by the pharmaceutical industry to increase patient awareness of products, affects both consumer behavior and, ultimately, physician prescribing practices. Billions of dollars are budgeted each year for DTCA, and its influence is far-reaching. However, little information is available about patient-initiated physician interactions in which television-bbased DTCA has played a role in consumer behavior. The objective of this study was to explore the influence of television-based DTCA on treatment changes in patient-initiated medication use. A 68-item survey instrument consisting of dichotomous, multiple-choice, and open-ended questions was constructed and sent to a convenience sample of US residents during 3 consecutive months ending in February 2005. The survey, which was accessed through an Internet link provided in the e-mail, was designed to capture data about patient perceptions and behaviors regarding television-based DTCA of prescription medications used for seasonal allergy and asthma as well as demographic information. Inferential and descriptive analyses were performed. Key tests included Crosstabs analysis and normal approximation to the binomial test with the z score. Surveys were sent to 2500 individuals. A total of 427 valid surveys were returned for a 17.1% response rate. Of the 402 respondents (94.1%) who stated that they had seen DTCA for seasonal allergy medication, 50 (12.4%) said they had discussed the advertised medication with their physician and 22 of those discussions (44.0%) resulted in a change in treatment. Three hundred forty-two respondents (80.1%) stated that they had viewed DTCA for prescription asthma medications, and 23 of those respondents (6.7%) said that they had discussed the brand of asthma medication viewed on television with their physician. Those discussions resulted in a change in treatment for 9 respondents (39.1%). Within th his limited, self
Delbaere, Marjorie; Smith, Malcolm C
This research develops a framework for understanding how consumers process health-related information and interact with their caregivers. The context is direct-to-consumer (DTC) advertising by pharmaceutical companies in North America. This theoretical research presents a research framework and focuses on the presentation of information in advertisements, consumer-learning processes, consumer utilization of health care knowledge, and bias in perceived risk. The paper proposes that consumers who lack expertise with prescription drugs learn from DTC ads differently than those with expertise. Further, it is proposed that consumers also process the information in DTC ads differently depending on the perceived effectiveness of the drug being advertised, and ultimately utilize the knowledge taken from the ads in many different ways, some of which may appear irrational to health care providers. By understanding how consumers interpret and learn from DTC ads, health care organizations and providers may be able to improve health care delivery and consumer outcomes.
...The Food and Drug Administration (FDA) is reopening the comment period on specific data related to a proposed rule published in the Federal Register of March 29,, to establish standards that would be considered in determining whether the major statement in direct-to- consumer (DTC) television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner. In the Federal Register of January 27, 2012, FDA announced that it had added a document to the docket for the proposed rulemaking concerning a study entitled ``Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements'' (Distraction Study) and the public was given until February 27, 2012, to comment on this study as it relates to the proposed standards. FDA is reopening the comment period for the rulemaking proceeding in response to a request for more time to submit comments to the Agency.
Bhutada, Nilesh S; Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew
Online surveys were conducted to determine the impact of endorser credibility, endorser effectiveness, and consumers' involvement in direct-to-consumer advertising. In a randomized posttest only study, using the elaboration likelihood model, survey participants (U.S. adults) were either exposed to a fictitious prescription drug ad with a celebrity or a noncelebrity endorser. There was no significant difference in credibility and effectiveness between the celebrity and the noncelebrity endorser. High involvement consumers viewed the ad more favorably and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, consumers' involvement did not moderate the effect of celebrity endorser.
Rollins, Brent L; King, Karen; Zinkhan, George; Perri, Matthew
Recently, pharmaceutical manufacturers have increased the amount of nonbranded, disease-education focused, direct-to-consumer advertisements. A comparison to branded, product-specific, ads was examined through a series of survey questions measuring consumer attitudes and the role of involvement. Nonbranded ads compared favorably to branded ads and should remain a viable part of the marketing mix. Consumers' level of disease state involvement was the strongest determinant of attitudes overall and within the two ad groupings, as highly involved consumers had significantly more positives attitudes regarding the nonbranded ads. Regardless of involvement level, however, nonbranded ads maintained positive attitude levels.
Mathur, Maya B; Gould, Michael; Khazeni, Nayer
Background: Direct-to-consumer (DTC) prescription drug advertisements are thought to induce "boomerang effects," meaning they reduce the perceived effectiveness of a potential alternative option: non-pharmaceutical treatment via lifestyle change. Past research has observed such effects using artificially created, text-only advertisements that may not adequate capture the complex, conflicting portrayal of lifestyle change in real television advertisements. In other risk domains, individual "problem status" often moderates boomerang effects, such that subjects who currently engage in the risky behavior exhibit the strongest boomerang effects. Objectives: We aimed to assess whether priming with real DTC television advertisements elicited boomerang effects on perceptions of lifestyle change and whether these effects, if present, were moderated by individual problem status. Methods: We assembled a sample of real, previously aired DTC television advertisements in order to naturalistically capture the portrayal of lifestyle change in real advertisements. We randomized 819 adults in the United States recruited via Amazon Mechanical Turk to view or not view an advertisement for a prescription drug. We further randomized subjects to judge either lifestyle change or drugs on three measures: general effectiveness, disease severity for a hypothetical patient, and personal intention to use the intervention if diagnosed with the target health condition. Results: Advertisement exposure induced a statistically significant, but weak, boomerang effect on general effectiveness ( p = 0.01, partial R 2 = 0.007) and did not affect disease severity score ( p = 0.32, partial R 2 = 0.0009). Advertisement exposure elicited a reverse boomerang effect of similar effect size on personal intentions, such that advertisement-exposed subjects reported comparatively higher intentions to use lifestyle change relative to drugs ( p = 0.006, partial R 2 = 0.008). Individual problem status did not
Majumdar, Sumit R; Soumerai, Stephen B
Objective To assess the impact of direct to consumer advertising of prescription drugs in the United States on Canadian prescribing rates for three heavily marketed drugs—etanercept, mometasone, and tegaserod. Design Controlled quasi-experimental study using interrupted time series analysis. Population Representative sample of 2700 Canadian pharmacies and prescription data from 50 US Medicaid programmes. Main outcome measures Differences in number of filled prescriptions per 10 000 population per month between English speaking and French speaking (control) Canadian provinces before and after the start of direct to consumer advertising in the United States. Results Spending on direct to consumer advertising for study drugs ranged from $194m to $314m (£104m-£169m; €131m-€212m) over the study period. Prescription rates for etanercept and mometasone did not increase in English speaking provinces relative to French speaking controls after the start of direct to consumer advertising. In contrast, tegaserod prescriptions increased 42% (0.56 prescriptions/10 000 residents, 95% confidence interval 0.37 to 0.76) in English speaking provinces immediately after the start of US direct to consumer advertising. Uncontrolled analysis of US Medicaid data showed a larger 56% increase in tegaserod prescriptions. However, this increase did not persist over time in either country, despite continued advertising. Conclusions Exposure to US direct to consumer advertising transiently influenced both Canadian and US prescribing rates for tegaserod, a drug later withdrawn owing to safety concerns. The impact of direct to consumer advertising on drug use seems to be highly variable and probably depends on the characteristics of the advertised drug, the level of exposure to direct to consumer advertising, and the cultural context. PMID:18765444
Law, Michael R; Majumdar, Sumit R; Soumerai, Stephen B
To assess the impact of direct to consumer advertising of prescription drugs in the United States on Canadian prescribing rates for three heavily marketed drugs-etanercept, mometasone, and tegaserod. Controlled quasi-experimental study using interrupted time series analysis. Representative sample of 2700 Canadian pharmacies and prescription data from 50 US Medicaid programmes. Differences in number of filled prescriptions per 10,000 population per month between English speaking and French speaking (control) Canadian provinces before and after the start of direct to consumer advertising in the United States. Spending on direct to consumer advertising for study drugs ranged from $194m to $314m ( pound104m- pound169m; euro131m-euro212m) over the study period. Prescription rates for etanercept and mometasone did not increase in English speaking provinces relative to French speaking controls after the start of direct to consumer advertising. In contrast, tegaserod prescriptions increased 42% (0.56 prescriptions/10,000 residents, 95% confidence interval 0.37 to 0.76) in English speaking provinces immediately after the start of US direct to consumer advertising. Uncontrolled analysis of US Medicaid data showed a larger 56% increase in tegaserod prescriptions. However, this increase did not persist over time in either country, despite continued advertising. Exposure to US direct to consumer advertising transiently influenced both Canadian and US prescribing rates for tegaserod, a drug later withdrawn owing to safety concerns. The impact of direct to consumer advertising on drug use seems to be highly variable and probably depends on the characteristics of the advertised drug, the level of exposure to direct to consumer advertising, and the cultural context.
While direct-to-consumer (DTC) prescription drug advertising has been the subject of ongoing debate, to this point the perspective of the advertising professionals engaged in creating these ads has been absent from the discussion. This study, consisting of in-depth interviews with advertising professionals (N = 22), was an initial investigation focused on these individuals. The primary purpose of this study was to explore advertising professionals' understanding of health literacy-consumers' ability to obtain, process, and act on health information; with that context in place, participants' views on the role of DTC advertising, industry regulations, and the future of the industry were also investigated. While some participants knew nothing about health literacy or had a relatively simple conceptualization (e.g., grade level of written materials), others exhibited more nuanced understanding of health literacy (e.g., the need to pair relevant images with text to enhance understanding). Participants spoke of the potential public health benefit of DTC advertising in educating consumers about health issues, but were realistic that such efforts on the part of pharmaceutical companies were driven primarily by business concerns-educational messages need to be tied directly to an advertised medication and its benefits. These professionals spoke of industry regulations as presenting additional barriers to effective communication and suggested that industry trends toward more niche products will necessitate more patient education about less well-known health issues. Directions for future research are considered, as more investigation of this understudied group is necessary to enrich the DTC prescription drug advertising debate.
Pinto, M B
The past decade has seen a steady rise in expenditures for direct-to-consumer pharmaceutical advertising. While total revenues across all media are approaching the $1 billion dollar mark, surprisingly little is known about the effectiveness of these types of advertisements, including the appropriateness of various forms of emotional and informational appeal. A content analysis of direct-to-consumer advertising in 24 popular magazines shows that these advertisements are found in every category of magazine, the advertisements employ a mix of informational and emotional appeals, all types of emotional appeals are used, and to date, the type of appeal (emotional and/or informational) tends not to be based on the type of drug advertised. Implications of this content analysis are considered and directions for research on appeals used in direct-to-consumer advertising are suggested.
Fahim, Germin; Toscani, Michael; Barone, Joseph A; Wang, Chris; Gandhi, Shivani
The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. Lack of consistency exists between risks versus benefit proportions among different drug products.
Lee, Annisa Lai
This study tracks the changes of the effects of 4 information sources for direct-to-consumer drug advertising on patients' requests for prescription drugs from physicians since the inception of the "Guidance for Industry about Consumer-directed Broadcast Advertisements." The Guidance advises pharmaceuticals to use four information sources for consumers to seek further information to supplement broadcast drug advertisements: small-print information, the Internet, a toll-free number, and health-care providers (nurses, doctors, and pharmacists). Logistic models were created by using survey data collected by the Food and Drug Administration in 1999 and 2002. Results show that throughout the years, health-care providers remain the most used and strongest means associated with patients' direct requests for nonspecific and specific prescription drugs from doctors. The small-print information source gains power and changes from an indirect means associated with patients' discussing drugs with health-care providers to a direct means associated with patients' asking about nonspecific and specific drugs from their doctors. The Internet is not directly related to drug requests, but the effect of its association with patients seeking information from health-care providers grew 11-fold over the course of the study. The toll-free number lost its power altogether for both direct request for a prescription drug and further discussion with health-care providers. Patient demographics will be considered for specific policy implications.
Lovett, Kimberly M; Mackey, Timothy K; Liang, Bryan A
Unsupervised online direct-to-consumer (DTC) access to medical services has rapidly expanded to medical screening tests, which have not been critically evaluated for their evidence basis. The objective of this study is to identify the scope of online-advertised DTC screening tests, outline the evidence for use of available DTC testing and suggest regulatory reform to address the relevant issues. An observational study of website advertisements, testing services and counselling/follow-up services for DTC testing was conducted. Data were collected from websites between 4 April and 1 June 2011. Each website was assessed for tests offered, advertised indications and availability of counselling/follow-up services. Advertised testing indications were compared with US Preventive Services Task Force recommendations and/or specialty guidelines and categorized as Supported, Against, Insufficient Evidence or No Guidance. Of 20 companies identified as offering DTC screening tests, 95% (19/20) do not clearly offer pretest counselling, post-test counselling and/or test follow-up. One hundred and twenty-seven different tests were identified. Only 19/127 (15%) could be Supported for screening in a target group selected for testing; 38/127 (30%) were given recommendations to avoid use in specific target group(s) selected for testing ('Against recommendations'); 29/127 (23%) had Insufficient Evidence of value, and for 64/127 (50%) No Guidance could be given. Only 4/127 (3%) tests were Supported for general screening use. Virtually all identified medical tests advertised and offered DTC are not recommended for use in screening by evidence-based guidelines. Limited oversight may lead to inaccurate self-diagnosis, treatment and wasted health resources.
In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.
Ogunwale, B; Clarke, J; Young, D; Mohammed, A; Patil, S; Meek, R M D
With increased use of the internet for health information and direct to consumer advertising from medical companies, there is concern about the quality of information available to patients. The aim of this study was to examine the quality of health information on the internet for hip resurfacing. An assessment tool was designed to measure quality of information. Websites were measured on credibility of source; usability; currentness of the information; content relevance; content accuracy/completeness and disclosure/bias. Each website assessed was given a total score, based on number of scores achieved from the above categories websites were further analysed on author, geographical origin and possession of an independent credibility check. There was positive correlation between the overall score for the website and the score of each website in each assessment category. Websites by implant companies, doctors and hospitals scored poorly. Websites with an independent credibility check such as Health on the Net (HoN) scored twice the total scores of websites without. Like other internet health websites, the quality of information on hip resurfacing websites is variable. This study highlights methods by which to assess the quality of health information on the internet and advocates that patients should look for a statement of an "independent credibility check" when searching for information on hip resurfacing.
O'Donoghue, Amie C; Sullivan, Helen W; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J
We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drug's benefits and, if so, which numerical format is most helpful. We conducted a randomized, controlled study of individuals diagnosed with high cholesterol (n=2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual's knowledge of a drug's efficacy, which may improve patient-provider communication and promote more informed decisions. Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs. Published by Elsevier Ireland Ltd.
Williams, Pamela A; O'Donoghue, Amie C; Sullivan, Helen W; Willoughby, Jessica Fitts; Squire, Claudia; Parvanta, Sarah; Betts, Kevin R
Drug efficacy can be measured by composite scores, which consist of two or more symptoms or other clinical components of a disease. We evaluated how individuals interpret composite scores in direct-to-consumer (DTC) prescription drug advertising. We conducted an experimental study of seasonal allergy sufferers (n=1967) who viewed a fictitious print DTC ad that varied by the type of information featured (general indication, list of symptoms, or definition of composite scores) and the presence or absence of an educational intervention about composite scores. We measured composite score recognition and comprehension, and perceived drug efficacy and risk. Ads that featured either (1) the composite score definition alone or (2) the list of symptoms or general indication information along with the educational intervention improved composite score comprehension. Ads that included the composite score definition or the educational intervention led to lower confidence in the drug's benefits. The composite score definition improved composite score recognition and lowered drug risk perceptions. Adding composite score information to DTC print ads may improve individuals' comprehension of composite scores and affect their perceptions of the drug. Providing composite score information may lead to more informed patient-provider prescription drug decisions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Williams, Bethan; Brown, David
To evaluate a sample of Internet sites advertising statins for sale to the general public. A simulated customer search and evaluation of retrieved sites using evaluation tools focussing on quality (Q) and safe medicine use (SMU). Sites retrieved on 17 November 2010 were systematically analysed from 19 November to 23 December 2010. One hundred eighty-four sites met the inclusion criteria: 40 each for atorvastatin, pravastatin, rosuvastatin, and simvastatin and 24 for fluvastatin. Sites originated from 17 different countries. Most sites scored less than half the maximum Q score (26; range 5-17). Mean total SMU scores for each statin group were lower than 50% of the maximum (45; range of 0-28). There were no statistically significant differences between statins. General contraindications were absent in 92.4% of sites and contraindicated medicines in 47.3%. Key warnings on the appearance of symptoms associated with myopathy, liver disease, hypersensitivity, and pancreatitis were absent in 37, 48.4, 91.3, and 96.2% of sites, respectively. Most websites presented a chaotic and incomplete list of known side effects; just 13 (7.1%) presented a list compatible with current prescribing information. Only two-thirds (65.8%) attempted to describe any in lay language. A potential purchaser of statins is likely to encounter websites from a wide geographical base and of generally poor quality. This has potentially serious implications for the safety of purchasers who may not be aware of the problems associated with ordering medicines online or the actual medication, which they receive. Direct to consumer advertising websites need tighter controls. Copyright © 2012 John Wiley & Sons, Ltd.
Morgan, Steven; Mintzes, Barbara; Barer, Morris
According to economic theory, one might expect that the informational content of direct-to-consumer advertising of prescription-only drugs would improve consumers' welfare. However, contrasting the models of consumer and market behaviour underlying this theory with the realities of the prescription-only drug market reveals that this market is distinct in ways that render it unlikely that advertising will serve an unbiased and strictly informative function. A review of qualitative evidence regarding the informational content of drug advertising supports this conclusion. Direct-to-consumer prescription drug advertising concentrates on particular products, and features of those products, to the exclusion of others, and the information provided has frequently been found to be biased or misleading in regulatory and academic evaluations. Governments that have so far resisted direct-to-consumer advertising should invest in independent sources of evidence that could help consumers and professionals to better understand the risks and benefits of treating disease with alternative drug and non-drug therapies, rather than permitting direct-to-consumer prescription drug advertising.
Full Text Available Kim’s overview of Food and Drug Administration (FDA regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved (“off-label” use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges.
Kim's overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved ("off-label") use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges. © 2016 by Kerman University of Medical Sciences.
Rollins, Brent L; Ramakrishnan, Shravanan; Perri, Matthew
Direct-to-consumer (DTC) advertising of predictive genetic tests (PGTs) has added a new dimension to health advertising. This study used an online survey based on the health belief model framework to examine and more fully understand consumers' responses and behavioral intentions in response to a PGT DTC advertisement. Overall, consumers reported moderate intentions to talk with their doctor and seek more information about PGTs after advertisement exposure, though consumers did not seem ready to take the advertised test or engage in active information search. Those who perceived greater threat from the disease, however, had significantly greater behavioral intentions and information search behavior.
Limbu, Yam; Torres, Ivonne M
This article examines consumers' attitudes toward Direct-to-Consumer (DTC) advertising of prescription drugs that are influenced by the use different types of DTC ads and product involvement. Our findings suggest that product involvement and the type of DTC ad are significant predictors of consumers' attitudinal responses toward DTC advertising. High involvement consumers have more favorable attitudes toward the drug's price, DTC ad and brand name, and a higher intention to ask a doctor about the advertised drug than low involvement consumers. In contrast to Informational and Reminder DTC ads, Persuasive ads have more favorable effects on consumers' reactions to DTC prescription drug advertising.
Granada Guzmán, Natalia Alexandra
Este proyecto se origina en el interés de analizar las estrategias actuales de promoción de productos farmacéuticos, en el marco del debate sobre el efecto persuasivo o informativo que la publicidad directa tiene sobre los consumidores. El objetivo es determinar el efecto de las estrategias de promoción directa para consumidores (Direct to Consumer Advertising [DTCA]) sobre el comportamiento de compra de pacientes y las prescripciones que formulan los médicos en el mercado de productos bajo r...
Hansen, Richard A; Schommer, Jon C; Cline, Richard R; Hadsall, Ronald S; Schondelmeyer, Stephen W; Nyman, John A
Previous research on the impact of various cost-sharing strategies on prescription drug use has not considered the impact of direct-to-consumer (DTC) advertising. To explore the association of cost-containment strategies with prescription drug use and to determine if the association is moderated by DTC prescription drug advertising. The study population included 288 280 employees and dependents aged 18 to 65 years with employer-sponsored health insurance contributing to the MEDSTAT MarketScan administrative data set. Person-level enrollment and claims data were obtained for beneficiaries enrolled continuously during July 1997 through December 1998. Direct-to-consumer advertising data were obtained from Competitive Media Reporting and linked to the MEDSTAT enrollment files. Localized DTC advertising expenditures for one class of medication were evaluated and matched with prescription claims for eligible MEDSTAT contributors. The association of various types and levels of cost-sharing incentives with incident product use was evaluated, controlling for the level of DTC advertising, health status, and other demographic covariates. The relationship of cost-sharing amounts with drug use was modified by the level of DTC advertising in a geographic market. This relationship was dependent on the type of cost-sharing, distinguishing between co-payments for provider visits and co-payments for prescription drugs. Compared with low-advertising markets, individuals residing in markets with high levels of advertising and paying provider co-payments of $10.00 or more were more likely to use the advertised product. In the same markets, higher prescription drug co-payments were associated with a decreased likelihood of using the advertised product. A similar relationship was not observed for the nonadvertised competitor. Among insured individuals, response to cost-sharing strategies is moderated by DTC prescription drug advertising. The relative ability of cost-sharing strategies to
The potential for both positive and negative effects arising from direct-to-consumer advertising of prescription medicines challenges health policymakers to develop regulatory schemes which selectively capture the positive aspects of the practice. Australia has dealt with this quandary by banning the practice, while New Zealand and the United States permit it. However, in recent times pharmaceutical companies have been increasingly successful in introducing promotional materials into the Australian market. This article demonstrates that the Australian ban is consistent with striving for the major policy goal of quality use of medicines, thus providing the basis for arguing that solutions to strengthen the ban against the identified threats ought to be implemented. Quality use of medicines can be most effectively achieved via the combined effect of the strengthened ban and the mimicking of the limited positive aspects of direct-to-consumer advertising by government provision of non-promotional information to consumers.
Byrne, Sahara; Niederdeppe, Jeff; Avery, Rosemary J; Cantor, Jonathan
Previous research suggests that direct-to-consumer (DTC) advertisements for pharmaceutical drugs have the potential to influence consumers' perceptions of whether symptoms should be treated medically and/or through behavior change. However, the relative frequency of messages emphasizing these approaches in pharmaceutical advertising remains largely unknown. A content analysis of print and television advertisements for cholesterol management medication between 1994 and 2005 (for print) and between 1999 and 2007 (for television) was conducted. First, the extent to which established theoretical constructs drawn from health communication scholarship are depicted in the content of DTC cholesterol advertisements is quantified. Second, specific claims about behavior change inefficacy when a pharmaceutical alternative is available are identified. Findings indicate that DTC ads offer many mixed messages about the efficacy of diet and exercise in reducing cholesterol and risk of heart disease. Theoretical and practical implications of this work are discussed.
Khalil Zadeh, Neda; Robertson, Kirsten; Green, James A
The factors determining individuals' self-reported behavioural responses to direct to consumer advertising of prescription drugs were explored with an emphasis on 'at-risk' individuals' responses. Nationally representative cross-sectional survey. Community living adults in New Zealand. 2057 adults (51% women). Self-reported behavioural responses to drug advertising (asking a physician for a prescription, asking a physician for more information about an illness, searching the internet for more information regarding an illness and asking a pharmacist for more information about a drug). Multivariate logistic regressions determined whether participants' self-reported behavioural responses to drug advertising were predicted by attitudes towards advertising and drug advertising, judgements about safety and effectiveness of advertised drugs, self-reported health status, materialism, online search behaviour as well as demographic variables. Identifying as Indian and to a less extent Chinese, Māori and 'other' ethnicities were the strongest predictors of one or more self-reported responses (ORs 1.76-5.00, Ps advertising (ORs 1.34-1.61, all Psadvertising and may make uninformed decisions accordingly. The outcomes raise significant concerns relating to the ethicality of drug advertising and suggest a need for stricter guidelines to ensure that drug advertisements provided by pharmaceutical companies are ethical. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Vogel, Ronald J; Ramachandran, Sulabha; Zachry, Woodie M
The pharmaceutical industry employs a variety of marketing strategies that have previously been directed primarily toward physicians. However, mass media direct-to-consumer (DTC) advertising of prescription drugs has emerged as a ubiquitous promotional strategy. This article explores the economics of DTC advertising in greater depth than has been done in the past by using a 3-stage economic model to assess the pertinent literature and to show the probable effects of DTC advertising in the United States. Economics literature on the subject was searched using the Journal of Economic Literature. Health services literature was searched using computer callback devices. Spending on DTC advertising in the United States increased from $17 million in 1985 to $2.5 billion in 2000. Proponents of DTC advertising claim that it provides valuable product-related information to health care professionals and patients, may contribute to better use of medications, and helps patients take charge of their own health care. Opponents argue that DTC advertising provides misleading messages rather than well-balanced, evidence-based information. The literature is replete with opinions about the effects of prescription drug advertising on pharmaceutical drug prices and physician-prescribing patterns, but few studies have addressed the issues beyond opinion surveys. The economic literature on advertising effects in other markets, however, may provide insight. DTC advertising indirectly affects the price and the quantity of production of pharmaceuticals via its effect on changes in consumer demand.
Viale, Pamela Hallquist; Sanchez Yamamoto, Deanna
To obtain information about the knowledge and attitudes of oncology nurse practitioners (ONPs) concerning the effect of direct-to-consumer (DTC) advertising of prescription medications on prescribing patterns. Exploratory survey. Oncology Nursing Society Nurse Practitioner Special Interest Group members in the United States. 221 of 376 ONPs completed the survey (58%). Researcher-developed 12-question postal survey. Knowledge and attitudes of ONPs on DTC advertising effects on prescribing patterns. The findings were similar to those of previous studies of physicians regarding the number of visits when patients requested DTC-advertised medications. Major differences were the positive attitudes of ONPs toward potentially longer patient visits to explain and educate patients regarding medication requests based on DTC advertising and smaller percentages of ONPs who felt "pressured" to prescribe requested medications. ONPs have mixed opinions regarding the practice of DTC advertising but do not believe that they are influenced heavily by advertising with regard to prescriptive practices. ONPs consider patient encounters for education purposes as appropriate and include information about requested DTC-advertised medications in their approach to patient care. This is an exploratory survey of a specialty group of ONPs. More research is needed to further explore the practice of DTC advertising and potential influences on the prescribing patterns of ONPs. DTC advertising of prescription medications is increasing; ONPs need to increase their knowledge base about the potential for influences of prescriptive practices.
Robinson, Andrew R; Hohmann, Kirsten B; Rifkin, Julie I; Topp, Daniel; Gilroy, Christine M; Pickard, Jeffrey A; Anderson, Robert J
Previous studies have shown that direct-to-consumer (DTC) pharmaceutical advertising can influence consumer behavior and that many physicians have negative views of these advertisements. Physician and public opinions about these advertisements and how they may affect the physician-patient relationship are not well established. Mail survey of 523 Colorado physicians and 261 national physicians and telephone survey of 500 Colorado households asking respondents to rate their agreement with statements about DTC advertising. Most physicians tended to view DTC advertisements negatively, indicating that such advertisements rarely provide enough information on cost (98.7%), alternative treatment options (94.9%), or adverse effects (54.8%). Most also believed that DTC advertisements affected interactions with patients by lengthening clinical encounters (55.9%), leading to patient requests for specific medications (80.7%), and changing patient expectations of physicians' prescribing practices (67.0%). Only 29.0% of public respondents agreed that DTC advertising is a positive trend in health care and 28.6% indicated that advertisements make them better informed about medical problems; fewer indicated that advertisements motivated them to seek care (10.5%) or led them to request specific medications from their physicians (13.3%). Most physicians have negative views of DTC pharmaceutical advertising and see several potential effects of these advertisements on the physician-patient relationship. Many public respondents have similarly negative views, and only a few agree that they change their expectations of or interactions with physicians. While these advertisements may be influencing only a few consumers, it seems that the impact on physicians and their interactions with patients may be significant.
Tsai, Wan-Hsiu Sunny; Lancaster, Alyse R
This exploratory study applies Taylor's (1999) six-segment message strategy wheel to direct-to-consumer (DTC) pharmaceutical television commercials to understand message strategies adopted by pharmaceutical advertisers to persuade consumers. A convenience sample of 96 DTC commercial campaigns was analyzed. The results suggest that most DTC drug ads used a combination approach, providing consumers with medical and drug information while simultaneously appealing to the viewer's ego-related needs and desires. In contrast to ration and ego strategies, other approaches including routine, acute need, and social are relatively uncommon while sensory was the least common message strategy. Findings thus recognized the educational value of DTC commercials.
Price, Rebecca Anhang; Frank, Richard G; Cleary, Paul D; Goldie, Sue J
Both clinical guidelines and direct-to-consumer (DTC) advertising influence the use of new health care technologies, but little is known about their relative effects. The introduction of a cervical cancer screening test in 2000 offered a unique opportunity to assess the 2 strategies. To evaluate the effects of clinical guidelines and a targeted DTC advertising campaign on overall and appropriate use of human papillomavirus (HPV) DNA tests. Quasi-experimental study using difference-in-differences analysis. Data were MarketScan private insurance claims for 500,000 women aged 21 to 64 enrolled at least 12 consecutive months from January 2001 through December 2005. Both clinical guidelines and DTC advertising were associated with increases in overall HPV DNA test use. DTC advertising was associated with a statistically significant increase in HPV DNA test use in 2 groups of DTC cities (+5.57%, P advertising was associated with comparable increases in the probability of appropriate and inappropriate use of the HPV DNA test in primary screening. Clinical guideline releases from the American College of Obstetricians and Gynecologists, and by a cosponsored panel, were associated with greater increases in HPV DNA tests for appropriate primary screening than for inappropriate primary screening (β = 0.3347, P advertising was associated with increased overall use of a cervical cancer screening test, whereas clinical guidelines were differentially associated with increased appropriate use. These findings suggest distinct influences of consumer marketing and professional guidelines on the use of health care products and services.
Sullivan, Helen W; O'Donoghue, Amie C; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J
To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. Individuals diagnosed with high cholesterol (n=2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. Adding visual aids to DTC advertising may increase the public's knowledge of how well prescription drugs work. Published by Elsevier Ireland Ltd.
Fogel, Joshua; Teichman, Chaim
This study examines variables associated with seeking information from doctors, the Internet, and a combination of both doctors and Internet after exposure to direct-to-consumer advertisements. Data were analyzed from 462 college students. Younger age, women, and health insurance were associated with greater odds for doctor; women, subjective norms, intentions, and greater time since seen doctor were associated with greater odds for Internet; and African American, Hispanic, subjective norms, intentions, and health insurance were associated with greater odds for both doctor and Internet. Marketers of direct-to-consumer advertisements can use these findings for tailoring and targeting direct-to-consumer advertisements.
Sumpradit, Nithima; Ascione, Frank J; Bagozzi, Richard P
Direct-to-consumer (DTC) advertising of prescription drugs is a widely discussed issue in health care. However, little is known about the characteristics of the motivational themes used in this type of advertising. The aim of this study was to investigate the concurrent presentation of motivational themes in DTC print and television advertisements. The content analyses focused on advertisements of 2 targeted drug classes (cyclooxygenase-2 enzyme inhibitors and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) in magazines and on television. Targeted print advertisements (for celecoxib, rofecoxib, atorvastatin, pravastatin, and simvastatin) from September to December 2001 and targeted television advertisements (for celecoxib, rofecoxib, and simvastatin) from November 2001 were investigated. The motivational themes were assessed using a theoretical framework based on self-regulatory focus theory and cultural orientation. Self-regulatory focus was examined in terms of goal orientation (promotion vs prevention) and emotional aspects, (e.g., cheerfulness, dejection, quiescence, agitation). The cultural orientation was examined in terms of individualism versus collectivism. The visual-verbal match was categorized as direct if the audio and visual information was semantically redundant, as partial if it was partially related, and as no match at all if it was different or conflicting. Twelve print advertisements in 10 magazines and 4 television advertisements on 4 television networks were examined; the interrater reliability scores from 3 independent, trained judges ranged from 0.93 to 0.99. The score was low (0.57) in the visual-verbal match measurement for television advertisements. Products in the same category appeared to be promoted using different self-regulatory foci. For example, celecoxib and atorvastatin advertisements tended to be promotion oriented, whereas pravastatin advertisements tended to be prevention oriented. Motivational themes were found
Somes Grant W
Full Text Available Abstract Background Direct-to-consumer (DTC marketing of pharmaceuticals is controversial, yet effective. Little is known relating patterns of medication use to patient responsiveness to DTC. Methods We conducted a secondary analysis of data collected in national telephone survey on knowledge of and attitudes toward DTC advertisements. The survey of 1081 U.S. adults (response rate = 65% was conducted by the Food and Drug Administration (FDA. Responsiveness to DTC was defined as an affirmative response to the item: "Has an advertisement for a prescription drug ever caused you to ask a doctor about a medical condition or illness of your own that you had not talked to a doctor about before?" Patients reported number of prescription and over-the-counter (OTC medicines taken as well as demographic and personal health information. Results Of 771 respondents who met study criteria, 195 (25% were responsive to DTC. Only 7% respondents taking no prescription were responsive, whereas 45% of respondents taking 5 or more prescription medications were responsive. This trend remained significant (p trend .0009 even when controlling for age, gender, race, educational attainment, income, self-reported health status, and whether respondents "liked" DTC advertising. There was no relationship between the number of OTC medications taken and the propensity to discuss health-related problems in response to DTC advertisements (p = .4. Conclusion There is a strong cross-sectional relationship between the number of prescription, but not OTC, drugs used and responsiveness to DTC advertising. Although this relationship could be explained by physician compliance with patient requests for medications, it is also plausible that DTC advertisements have a particular appeal to patients prone to taking multiple medications. Outpatients motivated to discuss medical conditions based on their exposure to DTC advertising may require a careful medication history to evaluate for
Dieringer, Nicholas J; Kukkamma, Lisa; Somes, Grant W; Shorr, Ronald I
ABSTRACT: BACKGROUND: Direct-to-consumer (DTC) marketing of pharmaceuticals is controversial, yet effective. Little is known relating patterns of medication use to patient responsiveness to DTC. METHODS: We conducted a secondary analysis of data collected in national telephone survey on knowledge of and attitudes toward DTC advertisements. The survey of 1081 U.S. adults (response rate = 65%) was conducted by the Food and Drug Administration (FDA). Responsiveness to DTC was defined as an affirmative response to the item: "Has an advertisement for a prescription drug ever caused you to ask a doctor about a medical condition or illness of your own that you had not talked to a doctor about before?" Patients reported number of prescription and over-the-counter (OTC) medicines taken as well as demographic and personal health information. RESULTS: Of 771 respondents who met study criteria, 195 (25%) were responsive to DTC. Only 7% respondents taking no prescription were responsive, whereas 45% of respondents taking 5 or more prescription medications were responsive. This trend remained significant (p trend .0009) even when controlling for age, gender, race, educational attainment, income, self-reported health status, and whether respondents "liked" DTC advertising. There was no relationship between the number of OTC medications taken and the propensity to discuss health-related problems in response to DTC advertisements (p = .4). CONCLUSION: There is a strong cross-sectional relationship between the number of prescription, but not OTC, drugs used and responsiveness to DTC advertising. Although this relationship could be explained by physician compliance with patient requests for medications, it is also plausible that DTC advertisements have a particular appeal to patients prone to taking multiple medications. Outpatients motivated to discuss medical conditions based on their exposure to DTC advertising may require a careful medication history to evaluate for therapeutic
Krezmien, Elyse; Wanzer, Melissa Bekelja; Servoss, Timothy; LaBelle, Sara
In this study, 384 respondents provided quantitative and descriptive information about direct-to-consumer (DTC) pharmaceutical advertisements and factors related to message reception and drug adoption. The authors applied M. Booth-Butterfield's ( 2008 ) Standard Model to explain how DTC advertising is used in getting individuals to talk to their doctors about pharmaceutical drugs. The researchers predicted that individuals who talked with their physicians about a pharmaceutical drug (referred to as talkers) would differ from those who did not talk with their physicians (referred to as nontalkers) in a number of meaningful ways. Findings from this data set indicate that individuals who talked with their physician about a specific medication were more likely to be female, older, higher in need for cognition, and reported higher physician satisfaction. Total number of channels (TV, radio, newspaper, magazines, and the Internet) was negatively associated with talking to a physician about a specific medication, as was exposure to DTC advertisement on television. The authors offer explanations for these findings along with descriptive accounts of how talkers and nontalkers differed in their recall of DTC advertisement information. Copyright © Taylor & Francis Group, LLC
In a direct-to-consumer (DTC) medical advertisement an advertiser aims to convince consumers to use a medical product, such as a dietary supplement, a freely obtainable pain killer or a prescription drug. Such advertisements sometimes feature endorsers who claim to have experienced the desirable
Frosch, Dominick L.; Krueger, Patrick M.; Hornik, Robert C.; Cronholm, Peter F.; Barg, Frances K.
PURPOSE American television viewers see as many as 16 hours of prescription drug advertisements (ads) each year, yet no research has examined how television ads attempt to influence consumers. This information is important, because ads may not meet their educational potential, possibly prompting consumers to request prescriptions that are clinically inappropriate or more expensive than equally effective alternatives. METHODS We coded ads shown during evening news and prime time hours for factual claims they make about the target condition, how they attempt to appeal to consumers, and how they portray the medication and lifestyle behaviors in the lives of ad characters. RESULTS Most ads (82%) made some factual claims and made rational arguments (86%) for product use, but few described condition causes (26%), risk factors (26%), or prevalence (25%). Emotional appeals were almost universal (95%). No ads mentioned lifestyle change as an alternative to products, though some (19%) portrayed it as an adjunct to medication. Some ads (18%) portrayed lifestyle changes as insufficient for controlling a condition. The ads often framed medication use in terms of losing (58%) and regaining control (85%) over some aspect of life and as engendering social approval (78%). Products were frequently (58%) portrayed as a medical breakthrough. CONCLUSIONS Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health. PMID:17261859
Frosch, Dominick L; Krueger, Patrick M; Hornik, Robert C; Cronholm, Peter F; Barg, Frances K
American television viewers see as many as 16 hours of prescription drug advertisements (ads) each year, yet no research has examined how television ads attempt to influence consumers. This information is important, because ads may not meet their educational potential, possibly prompting consumers to request prescriptions that are clinically inappropriate or more expensive than equally effective alternatives. We coded ads shown during evening news and prime time hours for factual claims they make about the target condition, how they attempt to appeal to consumers, and how they portray the medication and lifestyle behaviors in the lives of ad characters. Most ads (82%) made some factual claims and made rational arguments (86%) for product use, but few described condition causes (26%), risk factors (26%), or prevalence (25%). Emotional appeals were almost universal (95%). No ads mentioned lifestyle change as an alternative to products, though some (19%) portrayed it as an adjunct to medication. Some ads (18%) portrayed lifestyle changes as insufficient for controlling a condition. The ads often framed medication use in terms of losing (58%) and regaining control (85%) over some aspect of life and as engendering social approval (78%). Products were frequently (58%) portrayed as a medical breakthrough. Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health.
Klara, Kristina; Kim, Jeanie; Ross, Joseph S
Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.
S. Stremersch (Stefan); V. Schwartz-Landsman (Vardit); S. Venkataraman (Sriram)
textabstractPatients increasingly request their physicians to prescribe specific brands of pharmaceutical drugs. A popular belief is that requests are triggered by direct-to-consumer advertising (DTCA). We examine the relationship between DTCA, patient requests, and prescriptions for statins. We
Background Both clinical guidelines and direct-to-consumer (DTC) advertising influence use of new health care technologies, but little is known about their relative effects. The introduction of a cervical cancer screening test in 2000 offered a unique opportunity to assess the two strategies. Objective To evaluate the effects of clinical guidelines and a targeted DTC advertising campaign on overall and appropriate use of human papillomavirus (HPV) DNA tests. Research Design Quasi-experimental study using difference-in-differences analysis. Data were MarketScan private insurance claims for 500,000 women ages 21 to 64 enrolled at least 12 consecutive months from January 2001 through December 2005. Results Both clinical guidelines and DTC advertising were associated with increases in overall HPV DNA test use. DTC advertising was associated with a statistically significant increase in HPV DNA test use in two groups of DTC cities (+5.57 percent, padvertising was associated with comparable increases in the probability of appropriate and inappropriate use of the HPV DNA test in primary screening. Clinical guideline releases from the American College of Obstetricians and Gynecologists, and by a co-sponsored panel, were associated with greater increases in HPV DNA tests for appropriate primary screening than for inappropriate primary screening (β=0.3347, padvertising was associated with increased overall use of a cervical cancer screening test, while clinical guidelines were differentially associated with increased appropriate use. These findings suggest distinct influences of consumer marketing and professional guidelines on the use of health care products and services. PMID:21150798
Bhutada, Nilesh S; Rollins, Brent L; Perri, Matthew
A randomized, posttest-only online survey study of adult U.S. consumers determined the advertising effectiveness (attitude toward ad, brand, company, spokes-characters, attention paid to the ad, drug inquiry intention, and perceived product risk) of animated spokes-characters in print direct-to-consumer (DTC) advertising of prescription drugs and the moderating effects of consumers' involvement. Consumers' responses (n = 490) were recorded for animated versus nonanimated (human) spokes-characters in a fictitious DTC ad. Guided by the elaboration likelihood model, data were analyzed using a 2 (spokes-character type: animated/human) × 2 (involvement: high/low) factorial multivariate analysis of covariance (MANCOVA). The MANCOVA indicated significant main effects of spokes-character type and involvement on the dependent variables after controlling for covariate effects. Of the several ad effectiveness variables, consumers only differed on their attitude toward the spokes-characters between the two spokes-character types (specifically, more favorable attitudes toward the human spokes-character). Apart from perceived product risk, high-involvement consumers reacted more favorably to the remaining ad effectiveness variables compared to the low-involvement consumers, and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, the moderating effect of consumers' involvement was not observed (nonsignificant interaction effect between spokes-character type and involvement).
Lee, Annisa Lai
A popular perception holds that physicians prescribe requested drugs to patients influenced by mass mediated direct-to-consumer prescription drug advertising. The phenomenon poses a serious challenge to the two-step flow model, which emphasizes the influence of opinion leaders on their followers and their legitimating power over the informing power of the mass media. This study investigates a 2002 Food and Drug Administration (FDA) survey and finds that patients searching for drug information through mass and hybrid media in newspapers and magazines' small print, the Internet, and toll-free numbers are more likely to seek information through interpersonal communication channels like health care providers. Patients using small print, toll-free numbers, one's own physician, and other physicians are associated with influencing their physicians with various drug-requesting behaviors. But physicians only prescribe requested drugs to patients who are influenced by other health care providers, such as pharmacists and other physicians, not the mass media. The influence of expert opinion leaders of drugs is so strong that the patients even would switch from their own unyielding physicians who do not prescribe drugs as advised by the pharmacists. Physicians and patients all are influenced more by other expert opinion leaders of drugs than by the mass media and therefore still uphold the basic tenet of the two-step model.
O'Donoghue, Amie C; Williams, Pamela A; Sullivan, Helen W; Boudewyns, Vanessa; Squire, Claudia; Willoughby, Jessica Fitts
Although pharmaceutical companies cannot make comparative claims in direct-to-consumer (DTC) ads for prescription drugs without substantial evidence, the U.S. Food and Drug Administration permits some comparisons based on labeled attributes of the drug, such as dosing. Researchers have examined comparative advertising for packaged goods; however, scant research has examined comparative DTC advertising. We conducted two studies to determine if comparative claims in DTC ads influence consumers' perceptions and recall of drug information. In Experiment 1, participants with osteoarthritis (n=1934) viewed a fictitious print or video DTC ad that had no comparative claim or made an efficacy comparison to a named or unnamed competitor. Participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In Experiment 2, participants with high cholesterol or high body mass index (n=5317) viewed a fictitious print or video DTC ad that had no comparative claim or made a comparison to a named or unnamed competitor. We varied the type of comparison (of indication, dosing, or mechanism of action) and whether the comparison was accompanied by a visual depiction. Participants who viewed print and video ads with named competitors had greater efficacy perceptions than participants who viewed unnamed competitor and noncomparative ads. Unlike Experiment 1, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drug's efficacy and risk; therefore, caution should be used when presenting
Leader, Amy E; Cashman, Rebecca; Voytek, Chelsea D; Baker, Jillian L; Brawner, Bridgette M; Frank, Ian
When the human papillomavirus (HPV) vaccine was approved in 2006, an extensive direct-to-consumer (DTC) advertising campaign raised awareness and promoted vaccination. This study explores adolescents' exposure to and understanding of the messages in these advertisements. Sixty-seven African American females participated in a focus group about DTC advertising for the HPV vaccine. Virtually all adolescents had seen an HPV vaccine DTC advertisement, but most did not understand the health information contained in it. If DTC advertising is to be an effective source of health information for adolescents in the future, it must take into account the unique features of an adolescent audience.
Curtis, Jeffrey R; Chen, Lang; Higginbotham, Phillip; Nowell, W Benjamin; Gal-Levy, Ronit; Willig, James; Safford, Monika; Coe, Joseph; O'Hara, Kaitlin; Sa'adon, Roee
Social media may complement traditional data sources to answer comparative effectiveness/safety questions after medication licensure. The Treato platform was used to analyze all publicly available social media data including Facebook, blogs, and discussion boards for posts mentioning inflammatory arthritis (e.g. rheumatoid, psoriatic). Safety events were self-reported by patients and mapped to medical ontologies, resolving synonyms. Disease and symptom-related treatment indications were manually redacted. The units of analysis were unique terms in posts. Pre-specified conditions (e.g. herpes zoster (HZ)) were selected based upon safety signals from clinical trials and reported as pairwise odds ratios (ORs); drugs were compared with Fisher's exact test. Empirically identified events were analyzed using disproportionality analysis and reported as relative reporting ratios (RRRs). The accuracy of a natural language processing (NLP) classifier to identify cases of shingles associated with arthritis medications was assessed. As of October 2015, there were 785,656 arthritis-related posts. Posts were predominantly US posts (75%) from patient authors (87%) under 40 years of age (61%). For HZ posts (n = 1815), ORs were significantly increased with tofacitinib versus other rheumatoid arthritis therapies. ORs for mentions of perforated bowel (n = 13) were higher with tocilizumab versus other therapies. RRRs associated with tofacitinib were highest in conditions related to baldness and hair regrowth, infections and cancer. The NLP classifier had a positive predictive value of 91% to identify HZ. There was a threefold increase in posts following television direct-to-consumer advertisement (p = 0.04); posts expressing medication safety concerns were significantly more frequent than favorable posts. Social media is a challenging yet promising data source that may complement traditional approaches for comparative effectiveness research for new medications.
Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E
While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. © 2011 The Authors; Internal Medicine Journal © 2011 Royal Australasian College of Physicians.
Bélisle-Pipon, Jean-Christophe; Williams-Jones, Bryn
Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising (DTCA). However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information (DTCI) campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA.
Park, Jin Seong; Ahn, Ho-Young Anthony
Based on a survey with members of an online consumer panel (N= 699), this study revealed that: (a) a substantial percentage of consumers held misperceptions about the chemical imbalance theory of depression; (b) personal and interpersonal experiences with depression positively related to such misperceptions; (c) overall, exposure to direct-to-consumer (DTC) antidepressant advertising did not significantly relate to misperceptions; and (d) DTC exposure magnified misperceptions when consumers were highly trustful of DTC advertising, whereas exposure diluted misperceptions when consumers were highly skeptical. Theoretical and practical implications of the research are discussed, especially in light of the social responsibility of DTC advertising.
Toshiaki Iizuka; Ginger Zhe Jin
We examine the effect of direct-to-consumer advertising (DTCA) of drug treatment on an important health habit, physical exercise. By learning the existence of a new drug treatment via DTCA, rational consumers may become careless about maintaining healthy lifestyles. Using the National Health Insurance Survey (NHIS) and MSA-level DTCA data, we find that the DTCA related to four chronic conditions -- diabetes, high cholesterol, over weight, and hypertension -- reduce the likelihood of engaging ...
Bell, R A; Kravitz, R L; Wilkes, M S
We conducted a content analysis of consumer-targeted prescription drug advertisements to explore trends in prevalence, shifts in the medical conditions for which drugs are promoted, reliance on financial and nonmonetary inducements, and appeals used to attract public interest. We collected the drug advertisements appearing in 18 consumer magazines from 1989 through 1998. Two judges independently coded each advertisement and placed it in a category pertaining to the target audience, use of inducements, and product benefits (mean kappa=0.93). We employed descriptive statistics, cross-tabulations, and curve estimation procedures. A total of 320 distinct advertisements were identified, representing 101 brands and 14 medical conditions. New advertisement and brand introductions increased dramatically during this decade. Advertisements for drugs used for dermatologic, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), and obstetric/gynecologic conditions were most common. Almost all of the advertisements were aimed at the potential user of the drug, not third-party intermediaries such as parents and spouses. Although most advertisements were gender-neutral, women were more likely to be exclusively targeted. One eighth of the advertisements offered a monetary incentive (eg, a rebate or money-back guarantee), and one third made an offer of additional information in printed or audio/video form. The most common appeals used were effectiveness, symptom control, innovativeness, and convenience. Consumer-directed prescription drug advertising has increased dramatically during the past decade. The pharmaceutical industry is turning to this type of advertising to generate interest in its products. Our data may be useful to physicians who want to stay abreast of the treatments that are being directly marketed to their patients.
Lemanski, Jennifer L; Villegas, Jorge
Since 1997, when the U.S. Food and Drug Administration first allowed prescription drug companies to release ads directly targeting the public, direct-to-consumer (DTC) advertising has become an integral part of the pharmaceutical industry marketing toolkit, reaching over $4 billion in 2005. In an experiment where cognitive load, a task that requires the investment of a subject's memory in an unrelated task; source credibility; and advertising appeal type (affective or cognitive) were manipulated, attitude toward the ad was measured for a print DTC meningitis vaccine ad. Main effect results for source credibility and advertising appeal type on attitude toward the ad were found, and interactions between manipulated variables were apparent when the individual difference variables related to a specific illness (vaccination history, living in a dorm, family members or friends who had suffered the illness) were taken into account.
Bradford, W David; Kleit, Andrew N; Nietert, Paul J; Ornstein, Steven
Although highly controversial, directto-consumer (DTC) television advertising for prescription drugs is an established practice in the US health care industry. While the US Food and Drug Administration is currently reexamining its regulatory stance, little evidence exists regarding the impact of DTC advertising on patient health outcomes. The objective of this research was to study the relationship between heavy television promotion of 3 major hydroxymethylglutaryl coenzyme A reductase inhibitors ("statins") and the frequency with which patients are able to attain low-density lipoprotein cholesterol (LDL-C) blood-level goals after treatment with any statin. We used logistic regression to determine achievement of LDL-C goals at 6 months after statin treatment, using electronic medical record extract data from patients from geographically dispersed primary care practices in the United States. We identified LDL-C blood levels as being at or less than goal, as defined by risk-adjusted guidelines published by the National Heart, Lung, and Blood Institute from the Adult Treatment Panel III (ATP III) data. A total of 50,741 patients, identified from 88 practices, were diagnosed with hyperlipidemia and had begun therapy with any statin medication during the 1998-2004 time period. In addition, total dollars spent each month on television advertising at the national and local levels for atorvastatin, pravastatin, and simvastatin were obtained. DTC advertising data were merged by local media market where the physician practice was located and by the month in which the patient was first prescribed a statin. The models were run for all patients who initiated therapy, and also on a subsample of patients who continued to receive prescriptions for the drugs for at least 6 months. Logistic regressions were used to predict the likelihood that each patient attained the ATP III LDL-C blood-level goals as a function of DTC advertising and other factors. High levels of national DTC
Objectives The factors determining individuals’ self-reported behavioural responses to direct to consumer advertising of prescription drugs were explored with an emphasis on ‘at-risk’ individuals’ responses. Design Nationally representative cross-sectional survey. Setting Community living adults in New Zealand. Participants 2057 adults (51% women). Primary outcome measures Self-reported behavioural responses to drug advertising (asking a physician for a prescription, asking a physician for more information about an illness, searching the internet for more information regarding an illness and asking a pharmacist for more information about a drug). Methods Multivariate logistic regressions determined whether participants’ self-reported behavioural responses to drug advertising were predicted by attitudes towards advertising and drug advertising, judgements about safety and effectiveness of advertised drugs, self-reported health status, materialism, online search behaviour as well as demographic variables. Results Identifying as Indian and to a less extent Chinese, Māori and ‘other’ ethnicities were the strongest predictors of one or more self-reported responses (ORs 1.76–5.00, Psmaterialism (ORs 1.02–1.03, Ps<0.01) also predicted one or more self-reported responses. Conclusions Taken together, the findings suggest individuals, especially those who are ‘at-risk’ (ie, with poorer self-reported health status, older, less educated, lower income and ethnic minorities), may be more vulnerable to drug advertising and may make uninformed decisions accordingly. The outcomes raise significant concerns relating to the ethicality of drug advertising and suggest a need for stricter guidelines to ensure that drug advertisements provided by pharmaceutical companies are ethical. PMID:29217723
Rosenberg, Benjamin D; Siegel, Jason T
Scholars across multiple domains have identified the presence of inconsistency-arousing information in direct-to-consumer prescription drug advertisements and have suggested that these appeals, which highlight differences between people's actual and desired lives, may create psychological disequilibrium. However, experimental assessment of the distinct influence of inconsistency-arousing information in this domain is rare. Guided by goal disruption theory-a framework that outlines people's reactions to goal expectation violations-we created direct-to-consumer advertisements designed to make people's life inconsistencies salient. The influence of these ads on people's perceptions of, and intentions to use, prescription drugs was then assessed. Results from a structural equation modeling analysis supported the proposed model, indicating that compared to a control ad, an ad containing a goal expectation violation manipulation resulted in higher levels of psychological disequilibrium; in turn, psychological disequilibrium led to positive evaluations of the ad and the drug, positive outcome expectations of the drug, increased purposive harm endurance, and increased usage intentions. The current results suggest a psychological pathway that begins with a negative goal expectation violation and ends with increased usage intentions and a greater willingness to endure harm to make use possible.
Full Text Available In the face of drugs advertising, what can we do? Is Direct-to-Consumer Advertising (DTCA designed to be beneficial by objectively presenting a product or are they rather seeking to convince us that their product is patently good? Through this song, the goal is to live the experience of a patient who is subject to drug advertising, by integrating into the stanzas the main ethical issues raised by advertising.
Wilkinson, Jack; Vail, Andy; Roberts, Stephen A
To establish how medically assisted reproduction (MAR) clinics report success rates on their websites. Websites of private and NHS clinics offering in vitro fertilisation (IVF) in the UK. We identified clinics offering IVF using the Choose a Fertility Clinic facility on the website of the Human Fertilisation and Embryology Authority (HFEA). Of 81 clinics identified, a website could not be found for 2, leaving 79 for inclusion in the analysis. Outcome measures reported by clinic websites. The numerator and denominator included in the outcome measure were of interest. 53 (67%) websites reported their performance using 51 different outcome measures. It was most common to report pregnancy (83% of these clinics) or live birth rates (51%). 31 different ways of reporting pregnancy and 9 different ways of reporting live birth were identified. 11 (21%) reported multiple birth or pregnancy rates. 1 clinic provided information on adverse events. It was usual for clinics to present results without relevant contextual information such as sample size, reporting period, the characteristics of patients and particular details of treatments. Many combinations of numerator and denominator are available for the purpose of reporting success rates for MAR. The range of reporting options available to clinics is further increased by the possibility of presenting results for subgroups of patients and for different time periods. Given the status of these websites as advertisements to patients, the risk of selective reporting is considerable. Binding guidance is required to ensure consistent, informative reporting. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Kon, Rachel H; Russo, Mark W; Ory, Bridget; Mendys, Phil; Simpson, Ross J
Statins are commonly used to reduce the risk of heart attacks and strokes. Despite the benefit and limited risks in properly identified patients, clinicians are often challenged by patient acceptance and adherence to these medications. To assess if patients and physicians may have unfounded safety concerns about hepatotoxicity from these medications, we surveyed physicians and patients. We found inconsistent liver function-monitoring practices as well as exaggerated fears of statin-induced hepatotoxicity. Patients who received risk information from their physician were more likely to accurately estimate hepatotoxic risk than patients receiving such information from other sources. We believe these misperceptions about the relative risk and benefits of statin therapy are propagated by direct-to-consumer advertising, which may emphasize potential adverse events relative to treatment benefits. These perceptions are likely to adversely affect statin adherence, and may be addressed by patient education.
Bhutada, Nilesh S; Rollins, Brent L
Direct-to-consumer (DTC) advertising is still a controversial topic for pharmaceutical manufacturers' and researchers, and while numerous studies have examined the DTC phenomenon, little research has examined the effect of gender, particularly gender of the endorser and consumer. The objective of this research was to assess the impact of the endorser (celebrity vs. expert vs. non-celebrity) and gender - both gender of the endorser and gender of the consumer - on consumers' attitudes and behaviors in response to a print disease-specific direct-to-consumer advertisement. Using Qualtrics consumer panel, data were obtained for 514 US adults (age 18 years and above) who demonstrated at least minimal symptoms of depression and need for monitoring based on the Patient Health Questionnaire (PHQ) score. Data were analyzed using a 3 (Endorser Type: Celebrity/Expert/Non-Celebrity) × 2 (Endorser Gender: Male/Female) × 2 (Consumer Gender: Male/Female) full factorial between subjects multivariate analysis of variance (MANOVA) and necessary univariate analysis. Only the type of the endorser (celebrity vs. expert vs. non-celebrity) used in the ad had a significant main effect on the dependent variables. Further univariate analyses revealed that, of the several dependent variables, endorser type had a significant influence only on attitude towards the ad, attention paid to the ad, and endorser credibility, with gender being non-significant in all cases. Expert endorser generated significantly more favorable levels of attitude towards the ad, and endorser credibility compared to the non-celebrity endorser. Celebrity endorser attracted more consumer attention towards the ad and generated favorable endorser credibility perceptions compared to the non-celebrity endorser. However, celebrity and expert endorsers did not significantly differ from each other on the abovementioned ad effectiveness variables. Lastly, endorser gender and consumer gender did not have a significant influence
Hansen, Richard A; Shaheen, Nicholas J; Schommer, Jon C
Switching from one proton pump inhibitor (PPI) to another is common, and may be related to factors other than efficacy and tolerability. The purposes of this study were to describe the incidence of therapeutic switching among PPI users, quantify direct ambulatory medical costs of switching, and characterize the relationship between product switching and variables hypothesized to influence a switch (eg, direct-to-consumer [DTC] advertising, structure of insurance coverage, disease diagnosis). This was a retrospective cohort study of health plans using 1998 data. The subjects were employees and dependents with employer-sponsored health insurance contributing to the Medstat Market-Scan administrative dataset. Using a commercially available database to quantify DTC advertising by marketing area, market-specific expenditures were matched to eligible subjects. Among PPI users, we identified those who switched from one product to another (switchers) and compared their utilization and spending with nonswitchers. We then evaluated the relationship between drug use and variables hypothesized to affect switching: DTC advertising, insurance characteristics, patient diagnosis, diagnostic procedures, comorbidities, age, and sex. The analysis used data for 396,500 individuals from 47 unique markets that were geographically well distributed, with population density similar to that of the United States overall. The sample was also comparable with US census estimates for age and sex among working adults and their dependents. Only 620 (6.3%) of PPI users switched products during the 1998 calendar year. Annual diagnostic and drug costs were >US $400 higher for switchers than nonswitchers. Subjects in areas with high levels of DTC advertising were 43% more likely to switch from lansoprazole to omeprazole than those in the low-expenditure areas. Additionally, patients paying prescription drug copayments >US $5 were 12% less likely to switch from lansoprazole to omeprazole than patients
Osinga, Ernst C.; Leeflang, Peter S. H.; Srinivasan, Shuba; Wieringa, Jaap E.
Marketing managers increasingly recognize the need to measure and communicate the impact of their actions on shareholder returns. This study focuses on the shareholder value effects of pharmaceutical direct-to-consumer advertising (DTCA) and direct-to-physician (DTP) marketing efforts. Although DTCA
Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew; Zinkhan, George M
The proliferation of both manufacturer-controlled and independent medication-related websites has aroused concern among consumers and policy-makers concerning the trustworthiness of Web-based drug information. The authors examine consumers' trust in on-line prescription drug information and its influence on information search behavior. The study design involves a retrospective analysis of data from a 1998 national survey. The findings reveal that trust in drug information from traditional media sources such as television and newspapers transfers to the domain of the Internet. Furthermore, a greater trust in on-line prescription drug information stimulates utilization of the Internet for information search after exposure to prescription drug advertising.
The pharmaceutical sector is one of the main markets in the European Union. The consumption of medicines is high and steadily increasing. However, the pharmaceutical market is subject to a wider range of restrictions than almost any other sector. The restrictions mainly apply to information provision and advertising practice within the community. One of the main features in pharmaceutical regulation is the ban on direct-to-consumer advertising (DTCA) of prescription medicines. However, an abolition of the ban is controversial in the European Community, especially as the pharmaceutical industry keeps pleading for its ability to use the highly effective marketing strategy of DTCA to promote prescription medicines to the general public. Such advertising is only allowed in two jurisdictions in the world, New Zealand and the United States. In both systems the impact of DTCA on the consumer and the economy has been subject to research. The outcome of these studies is outlined in this article. Since the European Commission has provided a new proposal to amend the current information practice regarding prescription medicines in 2008 (European Commission, Proposal for a Directive of the European Parliament and of the Council Amending, as Regards Information to the General Public on Medicinal Products Subject to Medical Prescription, Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, COM/2008/0663 final) it is time to examine different options to regulate the provision of information and discuss the need for a ban of DTCA.
The paper by Joel Weissman and colleagues addresses the increasingly important topic of the effects of direct-to-consumer advertising (DTCA) by pharmaceutical companies. The authors claim that their results should be reassuring to "those concerned about potential adverse health care consequences of DTCA". However, the study and analysis of the data are marred by several flaws that diminish the importance and relevance of the findings, including weakness in design, overgenerous interpretations, and failure to address key questions. Rather than informing the debate, the study amounts to little more than an advertisement for drug advertisements.
Full Text Available Background For the purpose of understanding the Food and Drug Administration’s (FDA’s concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs and warning letters issued by the FDA to pharmaceutical manufacturers. Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014 regarding online promotional activities, were content-analyzed. Results Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the
For the purpose of understanding the Food and Drug Administration's (FDA's) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. The FDA's warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of
Babar, Zaheer-Ud-Din; Siraj, Ashna Medina; Curley, Louise
Direct-to-consumer advertising (DTCA) has been present in some countries for nearly two decades. Its success and ramifications have been examined but not yet cataloged recently in a comprehensive manner. To review existing literature studies on the topic of DTCA techniques to provide an analysis of the current methods considered by drug marketers to enhance the effect of pharmaceutical product promotion and its success, as well as examine ramifications on the drug use process. A search of 7 electronic databases including MEDLINE and SCOPUS was conducted in December 2015, and updated until February 2016. A scientific review of literature (2008-2015) was performed to identify and collate information from relevant, peer reviewed original study articles investigating various DTCA techniques commonly employed in pharmaceutical promotion. A thematic analysis was undertaken to categorize categories of drug promotion, or techniques, and the saliency and impact of these. Nineteen original study articles were included in this review. All articles were based in the U.S. and New Zealand, where DTCA is legal. After reviewing all the articles, 4 themes with 11 subcategories were generated. These themes included disease mongering and medicalization, drug references, advertisement strategies and eDTCA. The themes describe different categories of techniques used to augment DTC advertisements to increase their impact and overall success in promoting a pharmaceutical product. Many DTCA techniques utilized by pharmaceutical marketers are beneficial to the success of DTC promotion of a drug. These techniques include the use of drug efficacy information, comparative claims, non-branded help seeking advertisements, formatted risks information, celebrity or expert endorsers and website trust factors. Through their use, public perception of the drug is made more favorable, increased attention is drawn to the advertisement, and the pharmaceutical product gains greater credibility and
Brooks, Eleanor; Geyer, Robert
Between 2001 and 2011 the pharmaceutical industry, supported by DG Enterprise, was engaged in an ongoing campaign to repeal/amend the European Union (EU) ban on direct-to-consumer advertising of prescription drugs (DTCA-PD). As it became increasingly clear that the ban would not be repealed, DTCA-PD supporters tried to shift the debate away from advertising and towards the provision of 'patient information' and the rights of patients to access such information. Meanwhile, a variety of national and European health organizations, supported by DG SANCO, sought to maintain the ban and oppose the industry-supported 'patient information' campaign. Instead, they promoted a concept of 'health information' that included all aspects of citizens' health, not just pharmaceuticals. This article aims to analyse the transition from DTCA-PD to patient information to health information and examine its implications for EU health policy as a complex policy space. The article examines the emergence and development of EU health policy and the evolution of the DTCA-PD debate through the lens of complexity theory. It analyses the nature of the semantic, political and policy transition and asks why it occurred, what it tells us about EU health policy and future EU health legislation and how it may be understood from a complexity perspective. The article concludes that the complexity framework is ideally suited for the field of public health and, in particular, the DTCA-PD debate. Having successfully shifted the policy-focus of the debate to patients' rights and health information, opponents of the legislation are likely to face their next battle in the realm of cyberspace, where regulatory issues change the nature of advertising. © 2012 Blackwell Publishing Ltd.
How Affiliation Disclosure and Control Over User-Generated Comments Affects Consumer Health Knowledge and Behavior: A Randomized Controlled Experiment of Pharmaceutical Direct-to-Consumer Advertising on Social Media.
DeAndrea, David Christopher; Vendemia, Megan Ashley
More people are seeking health information online than ever before and pharmaceutical companies are increasingly marketing their drugs through social media. The aim was to examine two major concerns related to online direct-to-consumer pharmaceutical advertising: (1) how disclosing an affiliation with a pharmaceutical company affects how people respond to drug information produced by both health organizations and online commenters, and (2) how knowledge that health organizations control the display of user-generated comments affects consumer health knowledge and behavior. We conducted a 2×2×2 between-subjects experiment (N=674). All participants viewed an infographic posted to Facebook by a health organization about a prescription allergy drug. Across conditions, the infographic varied in the degree to which the health organization and commenters appeared to be affiliated with a drug manufacturer, and the display of user-generated comments appeared to be controlled. Affiliation disclosure statements on a health organization's Facebook post increased perceptions of an organization-drug manufacturer connection, which reduced trust in the organization (point estimate -0.45, 95% CI -0.69 to -0.24) and other users who posted comments about the drug (point estimate -0.44, 95% CI -0.68 to -0.22). Furthermore, increased perceptions of an organization-manufacturer connection reduced the likelihood that people would recommend the drug to important others (point estimate -0.35, 95% CI -0.59 to -0.15), and share the drug post with others on Facebook (point estimate -0.37, 95% CI -0.64 to -0.16). An affiliation cue next to the commenters' names increased perceptions that the commenters were affiliated with the drug manufacturer, which reduced trust in the comments (point estimate -0.81, 95% CI -1.04 to -0.59), the organization that made the post (point estimate -0.68, 95% CI -0.90 to -0.49), the likelihood of participants recommending the drug (point estimate -0.61, 95% CI -0
Biegler, Paul; Vargas, Patrick
The risk that direct-to-consumer advertising of prescription pharmaceuticals (DTCA) may increase inappropriate medicine use is well recognized. The U.S. Food and Drug Administration addresses this concern by subjecting DTCA content to strict scrutiny. Its strictures are, however, heavily focused on the explicit claims made in commercials, what we term their "propositional content." Yet research in social psychology suggests advertising employs techniques to influence viewers via nonpropositional content, for example, images and music. We argue that one such technique, evaluative conditioning, is operative in DTCA. We further argue that evaluative conditioning fosters unjustified beliefs about drug safety and efficacy, antagonising the autonomy of viewers' choices about advertised medicines. We conclude that current guidelines are deficient in failing to account for evaluative conditioning, and that more research and debate are needed to determine the permissibility of this and other forms of nonpropositional persuasion.
Grenard, Jerry L; Uy, Visith; Pagán, José A; Frosch, Dominick L
To conduct a pilot study exploring seniors' perceptions of direct-to-consumer advertising (DTCA) of prescription drugs and how the advertisements might prepare them for making informed decisions with their physicians. We interviewed 15 seniors (ages 63-82) individually after they each watched nine prescription drug advertisements recorded from broadcast television. Grounded Theory methods were used to identify core themes related to the research questions. Four themes emerged from the interviews about DTCA: (1) awareness of medications was increased, (2) information was missing or misleading and drugs were often perceived as more effective than clinical evidence would suggest, (3) most seniors were more strongly influenced by personal or vicarious experience with a drug - and by their physician - than by DTCA, and (4) most seniors were circumspect about the information in commercial DTCA. DTCA may have some limited benefit for informed decision making by seniors, but the advertisements do not provide enough detailed information and some information is misinterpreted. Physicians should be aware that many patients may misunderstand DTCA, and that a certain amount of time may be required during consultations to correct these misconceptions until better advertising methods are employed by the pharmaceutical industry. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
Direct-to-consumer advertising (DTCA) of prescription drugs in the United States is controversial. Underlying the debate are disagreements over the role of consumers in medical decision making, the appropriateness of consumers engaging in self-diagnosis, and the ethics of an industry promoting potentially dangerous drugs. Drug advertising and federal policy governing drug advertising have both responded to and reinforced changes in the consumer's role in health care and in the doctor-patient relationship over time. This article discusses the history of DTCA in the context of social movements to secure rights for health care patients and consumers, the modern trend toward consumer-oriented medicine, and the implications of DTCA and consumer-oriented medicine for contemporary health policy debates about improving the health care system. PMID:17096638
Direct-to-consumer advertising (DTCA) of prescription drugs in the United States is controversial. Underlying the debate are disagreements over the role of consumers in medical decision making, the appropriateness of consumers engaging in self-diagnosis, and the ethics of an industry promoting potentially dangerous drugs. Drug advertising and federal policy governing drug advertising have both responded to and reinforced changes in the consumer's role in health care and in the doctor-patient relationship over time. This article discusses the history of DTCA in the context of social movements to secure rights for health care patients and consumers, the modern trend toward consumer-oriented medicine, and the implications of DTCA and consumer-oriented medicine for contemporary health policy debates about improving the health care system.
Park, Jin Seong; Ju, Ilwoo
This study aims to broaden the scope of knowledge on the role of direct-to-consumer prescription drug advertising (DTCA) in the construction of consumers' optimistic bias regarding health issues and their intentions for coping actions. Based on an online survey of U.S. adults aged 65 years or older (N = 622), this study revealed that (a) respondents were optimistically biased in estimating their future risk of Alzheimer's disease (AD); (b) exposure to DTCA for AD medicine related negatively to optimistic bias when respondents had a low level of knowledge about AD, while the relationship disappeared when knowledge was high; (c) optimistic bias was negatively associated with intentions to seek information about AD and professional help to discuss it; and (d) optimistic bias mediated the relationship between the DTCA exposure × AD knowledge interaction and information- and help-seeking intentions. Implications for the theory and practice of DTCA are discussed.
... consumer genetic testing? What kinds of direct-to-consumer genetic tests are available? What is genetic ancestry testing? What are the benefits and risks of direct-to-consumer genetic testing? ...
Vreugdenburg, Thomas D; Laurence, Caroline O; Willis, Cameron D; Mundy, Linda; Hiller, Janet E
To describe the nature and frequency of information presented on direct-to-consumer websites for emerging breast cancer imaging devices. Content analysis of Australian website advertisements from 2 March 2011 to 30 March 2012, for three emerging breast cancer imaging devices: digital infrared thermal imaging, electrical impedance scanning and electronic palpation imaging. Type of imaging offered, device safety, device performance, application of device, target population, supporting evidence and comparator tests. Thirty-nine unique Australian websites promoting a direct-to-consumer breast imaging device were identified. Despite a lack of supporting evidence, 22 websites advertised devices for diagnosis, 20 advertised devices for screening, 13 advertised devices for prevention and 13 advertised devices for identifying breast cancer risk factors. Similarly, advertised ranges of diagnostic sensitivity (78%-99%) and specificity (44%-91%) were relatively high compared with published literature. Direct comparisons with conventional screening tools that favoured the new device were highly prominent (31 websites), and one-third of websites (12) explicitly promoted their device as a suitable alternative. Australian websites for emerging breast imaging devices, which are also available internationally, promote the use of such devices as safe and effective solutions for breast cancer screening and diagnosis in a range of target populations. Many of these claims are not supported by peer-reviewed evidence, raising questions about the manner in which these devices and their advertising material are regulated, particularly when they are promoted as direct alternatives to established screening interventions.
Kornfield, Rachel; Alexander, G Caleb; Qato, Dima M; Kim, Yoonsang; Hirsch, Jan D; Emery, Sherry L
TV accounts for more than half of pharmaceutical direct-to-consumer advertising (DTCA) spending in the U.S. The purpose of this study is to quantify average household exposure to branded and non-branded (help-seeking) televised prescription drug advertisements and describe variation over time and according to medication indication and geography. In 2013, Nielsen TV ratings were compiled for prescription pharmaceutical advertising that aired between 2003 and 2011 for the top 75 U.S. media markets. All advertisements were coded as branded or help-seeking. Advertisements were further coded for one of eight prevalent indications (allergies, arthritis, asthma, erectile dysfunction, high cholesterol, smoking cessation, depression, and sleep disorder) or as "other." Televised DTCA exposure increased from 2003 to 2007 and then declined 43% by 2011, to 111 monthly prescription drug advertisements per household. The examined indications were associated with varying amounts and patterns of exposure, with greatest declines among medications for allergies and sleep disorders. Help-seeking advertisements comprised 10% of total exposure, with substantial variation by indication. Considerations of DTCA's effects on health care should take into account the shifting concentration of advertising across indications. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
... consumer genetic testing. Additional information about direct-to-consumer marketing of genetic tests and related research questions are ... for Links Data Files & API Site Map Subscribe Customer Support USA.gov Copyright Privacy Accessibility FOIA Viewers & ...
A prime is a cue that makes associated concepts, behaviors, and goals more psychologically accessible to people, influencing their responses in subsequent related environments. I build a case that Direct to Consumer Advertising of Prescription Pharmaceuticals (DTCA) operates as a prime that causes some viewers to prefer and pursue the advertised drug. Drawing on literature from social psychology I show that people subject to priming are mostly unaware of its influence and liable to misattribute the reasons for their primed actions. Misattribution typically includes heightened appraisals of the value of a primed goal. Consistent with this account, I argue that viewers primed by DTCA hold favorable, yet false beliefs about the safety and efficacy of the advertised drug. I further argue that, because those drug properties are material to viewers with the relevant illness, priming in DTCA can undermine the autonomy of their medicine choices. The threat to autonomy posed by priming in DTCA suggests it warrants attention from both regulators and the wider research community. It also adds further reason to be sceptical about the permissibility of this form of advertising.
The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy--but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach? This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing. DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," it can provide medical information as an incidental finding. 23andMe currently purports to be the
Ganz, Ollie; Teplitskaya, Lyubov; Cantrell, Jennifer; Hair, Elizabeth C; Vallone, Donna
Although cigar use and sales have increased in the United States over the past decade, little is known about how these products are promoted. Direct-to-consumer (DTC) advertising is a common method used to promote tobacco products and may be a potential channel through which cigars are advertised. Comperemedia (Mintel) was used to acquire opt-in direct mail and email advertising for the top 10 cigar brands in the United States between January 2013 and July 2014. The advertisement and corresponding data on brand, advertising spend, and mail volume were downloaded and summarized. Promotions such as coupons, giveaways, and sweepstakes were also examined. A total of 92 unique advertisements met the search criteria and included two brands: Black & Mild (n = 77) and Swisher Sweets (n = 15). Expenditures on direct mail advertising during this period totaled $12 809 630. Black & Mild encompassed 80% of total direct mail volume and 78% of direct mail advertising expenditures. Almost all advertisements contained at least one promotion (88%) and included a URL to the product website (85%). The results suggest that Black & Mild and Swisher Sweets are the primary cigar brands using DTC advertising. Promotional offers were nearly ubiquitous among the advertisements, which may appeal to price-sensitive populations. Future studies should continue to examine cigar advertising via direct mail and email, in addition to other channels, such as the point-of-sale. Although cigar use and sales have increased in the United States over the past decade, there is limited data on cigar advertising. This article provides a snapshot of expenditures, volume, and promotional content of DTC cigar advertising in the United States between January 2013 and July 2014. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: firstname.lastname@example.org.
Lau, Darren; Ogbogu, Ubaka; Taylor, Benjamin; Stafinski, Tania; Menon, Devidas; Caulfield, Timothy
Despite the immature state of stem cell medicine, patients are seeking and accessing putative stem cell therapies in an "early market" in which direct-to-consumer advertising via the internet likely plays an important role. We analyzed stem cell clinic websites and appraised the relevant published clinical evidence of stem cell therapies to address three questions about the direct-to-consumer portrayal of stem cell medicine in this early market: What sorts of therapies are being offered? How are they portrayed? Is there clinical evidence to support the use of these therapies? We found that the portrayal of stem cell medicine on provider websites is optimistic and unsubstantiated by peer-reviewed literature.
Marketing of genetic testing, although similar to direct-to-consumer advertising of prescription drugs, raises additional concerns and considerations. These include issues of limited knowledge among patients and health care providers of available genetic tests, difficulty in interpretation of genetic testing results, lack of federal oversight of companies offering genetic testing, and issues of privacy and confidentiality. Until all of these considerations are addressed, direct or home genetic testing should be discouraged because of the potential harm of a misinterpreted or inaccurate result.
Christiansen, Camilla Worm; Gerdes, Anne-Marie Axø
Direct-to-consumer genetic tests are sold over the internet to consumers all over the world - including Denmark. No regulation of these tests has been introduced neither in Denmark nor in Europe, even though they have been on the market since 2007. Such tests have several advantages, but indeed also a long list of potential disadvantages, which are most often ignored, and among these is insufficient training of general practitioners in performing the necessary counselling but also the risk of increased expenses to unnecessary follow-up consultations.
Ries, Nola M; Castle, David
A growing variety and number of genetic tests are advertised and sold directly to consumers (DTC) via the Internet, including nutrigenomic tests and associated products and services. Consumers have more access to genetic information about themselves, but access does not entail certainty about the implications of test results. Potential personal and public health harms and benefits are associated with DTC access to genetic testing services. Early policy responses to direct-to-consumer (DTC) genetic testing often involved calls for bans, and some jurisdictions prohibited DTC genetic tests. Recent policy responses by oversight bodies acknowledge expansion in the range of DTC tests available and suggest that a "one-size-fits-all" regulatory approach is not appropriate for all genetic tests. This review discusses ethical and regulatory aspects of DTC genetic testing, focusing particularly on nutrigenomic tests. We identify policy options for regulating DTC genetic tests, including full or partial prohibitions, enforcement of existing truth-in-advertising laws, and more comprehensive information disclosure about genetic tests. We advocate the latter option as an important means to improve transparency about current evidence on the strengths and limits of gene-disease associations and allow consumers to make informed purchasing decisions in the DTC marketplace.
Chao, Blenda A
The educational content of direct-to-consumer (DTC) fulfillment materials was evaluated. A list of prescription drug products advertised to consumers via broadcast media from August 1997 through April 20, 2002, was obtained from the Food and Drug Administration (FDA). The prescription products were categorized by disease state on the basis of their FDA-approved indications. Eight disease states were selected for analysis purposes and included acne, allergic rhinitis, depression, diabetes, hypercholesterolemia, migraine, overactive bladder, and osteoporosis. A total of 31 products were advertised directly to consumers for the eight targeted disease states, 26 of which met the inclusion criteria. The educational content of the advertisements for these 26 products was assessed by analyzing the materials' consistency, instructiveness, and consumer orientation. Two of the 26 materials analyzed contained claims that potentially broadened a drug's indication from that listed in the FDA-approved labeling. The majority of materials listed the condition name (92%), symptom information (77%), the drug's mechanism of action (65%), the drug's time to onset of action (54%), and supportive behaviors (62%). Twenty of 24 DTC fulfillment materials (83%) were not written at the reading level of eighth grade or lower. Fifteen of the 26 mailings contained educational diagrams, 52% of which met the criteria for necessity, and a greater percentage met the criteria for suitability (90%), familiarity (86%), overall layout (88%), single concept (86%), and lack of distracting elements (100%). DTC fulfillment materials appear to have more educational content than DTC print advertisements but are still overwhelmingly deficient in meeting the recommended sixth to eighth-grade reading level.
Geransar, Rose; Einsiedel, Edna
Commercialization of genetic technologies is expanding the horizons for the marketing and sales of genetic tests direct-to-consumers (DTCs). This study assesses the information provision and access requirements that are in place for genetic tests that are being advertised DTC over the Internet. Sets of key words specific to DTC genetic testing were entered into popular Internet search engines to generate a list of 24 companies engaging in DTC advertising. Company requirements for physician mediation, genetic counseling arrangements, and information provision were coded to develop categories for quantitative analysis within each variable. Results showed that companies offering risk assessment and diagnostic testing were most likely to require that testing be mediated by a clinician, and to recommend physician-arranged counseling. Companies offering enhancement testing were less likely to require physician mediation of services and more likely to provide long-distance genetic counseling. DTC advertisements often provided information on disease etiology; this was most common in the case of multifactorial diseases. The majority of companies cited outside sources to support the validity of claims about clinical utility of the tests being advertised; companies offering risk assessment tests most frequently cited all information sources. DTC advertising for genetic tests that lack independent professional oversight raises troubling questions about appropriate use and interpretation of these tests by consumers and carries implications for the standards of patient care. These implications are discussed in the context of a public healthcare system.
Full Text Available We examine how consumers react to direct-to-consumer advertising (DTCA by investigating the role of goal compatibility between motivation to process advertisements and consumer self-concept. Specifically, we examine the interaction between self-regulatory (prevention versus promotion focus and self-construal orientation (independent versus interdependent and find that prevention (versus promotion focused consumers form stronger intentions to speak with physicians and are more likely to discuss an advertised drug, when the ad uses an interdependence self-construal theme, whereas promotion (versus prevention focused consumers form stronger intentions to speak with physicians and are more likely to discuss an advertised drug, when the ad uses an independent self-construal theme. The above two-way interaction was further found to be governed by attitudes toward DTCA. Under goal compatibility, consumers who had positive or neutral attitudes toward DTCA (versus negative had stronger (a intentions to speak with physicians about the advertised drug, (b stronger intentions to speak with physicians about high cholesterol, (c greater likelihood of discussing the drug with health professionals, and (d greater likelihood of requesting a prescription, yet did not differ in perceptions of drug benefits and risks. Hypotheses were tested on a sample of 197 female staff and retirees (aged 40–80 years at a large university.
Since the global withdrawal of rofecoxib (Vioxx) in 2004, concerns about public health effects of direct-to-consumer advertising (DTCA) have grown. A systematic review of the research evidence on behavioral, health, and cost effects, published in 2005, found four studies meeting inclusion criteria, which showed that DTCA increases prescribing volume and patient demand, and shifts prescribing. From 2005 to 2010, nine studies met similar criteria. These largely confirm previous results. Additional effects include a shift to less appropriate prescribing, differential effects by patient price sensitivity and drug type, switches to less cost-effective treatment, and sustained sales despite a price increase. Claimed effects on adherence do not stand up to scrutiny and are based mainly on negative trials. There is no evidence of improved treatment quality or early provision of needed care. If policy is to be informed by evidence, the strength of research methods and ability to assess causality need to be considered.
Lamoril, Jérôme; Bogard, Marc
Since the development of new human genome sequencing technologies at the beginning of the 2000, commercial companies have developped direct to consumer genomic services, which means without medical prescription. From 2007 to 2013, many companies have offered services assesing associated risk with human public health in the world especially in the United States. This kind of company is forbidden in France. From 2009 to 2013, in United States, under the pressure of national or state health administrations, these companies have been progressively forbidden. However, in certain parts of the world, companies are still offering such services. The latter raise many different questions such as ethical, juridical, medical, scientific, educative, professional one. Many studies and debates have demonstrated their limit and the lack of usefulness and advantage in the field of human health for the time being. The commercialization of this type of services has arrived all too soon et is not yet ripe. In our time of globalization, with the lack of international rules controlling direct access to genetic services in the field of human health, there is an urgent need to regulate. International administrations and politicians must act fast. Inevitably, under the pressure of lobbies and citizens, companies (multinational or not) will develop especially as 1) new sequencing technologies evolve rapidly, 2) are cheaper from year to year, 3) scientific and medical knowledges are progressing quickly, 4) services are spreading faster through the web and other networks.
Lippi, G; Favaloro, E J; Plebani, M
As a result of incessant genetic discoveries and remarkable technological advancements, the availability and the consequent consumer's request for genetic testing are growing exponentially, leading to the development of a 'parallel' market, i.e. the direct-to-consumer (DTC) testing, also known as 'direct access testing' (DAT). Analogous to the traditional laboratory diagnostics, drawbacks of DTC testing might arise from any step characterising the total testing process, and include poor control of both appropriateness and preanalytical requirements, potential operation outside national or international regulation for in vitro diagnostic testing, little evidence of quality as well as the risk of transfer of genetic materials from the companies to other entities. Another important issue is the test panels offered to consumers, which are often based on preliminary, speculative or unsupported scientific information. Finally, the potential of this type of testing to generate anxiety or false reassurance should also be carefully considered. Although DTC testing carries some theoretical advantages (e.g. greater consumer autonomy and empowerment), solid clinical studies and costs vs. benefit analyses are needed to definitely establish whether DTC testing might be effective for decreasing the burden of diseases, delay their onset or modify their progression and therefore the clinical outcome. © 2011 Blackwell Publishing Ltd.
Hollon, Matthew F
In the US and New Zealand, the past decade has seen tremendous growth in the marketing of prescription drugs directly to patients. The pharmaceutical industry has applied pressure in other countries to relax regulations governing such marketing although this has not yet been successful. While we still have much to learn about the potential impact on the public's health of direct-to-consumer (DTC) marketing, some data are available. This article summarises the current literature on the benefits and risks of DTC marketing. This marketing strategy has grown substantially in the US, but only select drugs are advertised. Whether there is net benefit or harm to the public's health as a result of DTC marketing depends critically on which drugs are advertised and the quality of the information provided in promotional material. Critical reviews of this promotional material suggest the information is of poor quality. Notably, 18% of the 50 drugs advertised most intensively in the US were medications used to treat psychiatric and neurological disorders. The impairments in decisional capacity often seen in psychiatric and neurological illness leave patients vunerable to the controlling influence of DTC marketing and, thus, undermine the patient autonomy that is said to be promoted by this marketing strategy. If there is any benefit from DTC marketing it is for significantly undertreated conditions. International restrictions on DTC marketing should remain in place until further evidence of net benefit or harm emerges from the DTC marketing experiment that is taking place in the US and New Zealand.
Findlay, S D
Spending on outpatient prescription drugs in the US is accelerating rapidly. Although numerous factors are driving this trend, attention has recently focused on the role played by the marketing, promotion and advertising of pharmaceuticals, in particular direct-to-consumer (DTC) advertising. In 1997, the US Food and Drug Administration (FDA) issued a 'guidance' on such mass media promotion. The guidance altered existing FDA rules and effectively permitted pharmaceutical companies to promote prescription drugs on television and radio without giving detailed or even summary information on indications, efficacy or potential adverse effects. Since then, television commercials, in particular, and print advertisements in consumer magazines and newspapers have proliferated rapidly. Pharmaceutical companies spent $US1.8 billion on DTC advertising in 1999, a 40% increase over 1998. This spending in 1999 was heavily concentrated on about 50 drugs. Evidence is growing that DTC promotion of prescription drugs is: (i) alerting consumers to the existence of new drugs and the conditions they treat; (ii) increasing consumer demand for many drugs; (iii) contributing increasingly to the recent sharp increase in the number of prescriptions being dispensed; (iv) raising sales revenues; and, thus, (v) contributing to the higher pharmaceutical costs of health insurers, government and consumers. The public policy issues surrounding DTC advertisements centre on the following questions: (i) are the advertisements leading to the inappropriate clinical use of some drugs? (ii) are the advertisements inducing both consumers and physicians to choose more costly new brand-name drugs over less expensive, but equally effective, older brand or generic drugs? (iii) do television advertisements for prescription drugs contain a balanced amount of information on benefits versus potential adverse effects? and (iv) will the revenue benefits generated by DTC advertising cause pharmaceutical companies to
Direct-to-consumer (DTC) genetic services have generated enormous controversy from their first emergence. A dramatic recent manifestation of this is the Food and Drug Administration's (FDA) cease and desist order against 23andMe, the leading provider in the market. Critics have argued for the restrictive regulation of such services, and even their prohibition, on the grounds of the harm they pose to consumers. Their advocates, by contrast, defend them as a means of enhancing the autonomy of those same consumers. Autonomy emerges as a key battle-field in this debate, because many of the ‘harm’ arguments can be interpreted as identifying threats to autonomy. This paper assesses whether DTC genomic services are a threat to, or instead, an enhancement of, personal autonomy. It deploys Joseph Raz's account of personal autonomy, with its emphasis on choice from a range of valuable options. It then seeks to counter claims that DTC genomics threatens autonomy because it involves manipulation in contravention of consumers’ independence or because it does not generate valuable options which can be meaningfully engaged with by consumers. It is stressed that the value of the options generated by DTC genomics should not be judged exclusively from the perspective of medical actionability, but should take into consideration plural utilities. Finally, the paper ends by broaching policy recommendations, suggesting that there is a strong autonomy-based argument for permitting DTC genomic services, and that the key question is the nature of the regulatory conditions under which they should be permitted. The discussion of autonomy in this paper helps illuminate some of these conditions. PMID:24797610
Fogel, Alexander L; Teng, Joyce; Sarin, Kavita Y
Direct-to-consumer teledermatology is radically changing the way some patients obtain dermatologic care. Many direct-to-consumer teledermatology services offer care to patients younger than 18 years, but policies and standards are nonuniform. For pediatric patients, direct-to-consumer teledermatology is a substantial departure from in-person care. More consensus, standards, and guidelines are necessary. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Vrecar, Irena; Peterlin, Borut; Teran, Natasa; Lovrecic, Luca
Over the last few years, many private companies are advertising direct-to-consumer genetic testing (DTC GT), mostly with no or only minor clinical utility and validity of tests and without genetic counselling. International professional community does not approve provision of DTC GT and situation in some EU countries has been analysed already. The aim of our study was to analyse current situation in the field of DTC GT in Slovenia and related legal and ethical issues. Information was retrieved through internet search, performed independently by two authors, structured according to individual private company and the types of offered genetic testing. Five private companies and three Health Insurance Companies offer DTC GT and it is provided without genetic counselling. Available tests include testing for breast cancer, tests with other health-related information (complex diseases, drug responses) and other tests (nutrigenetic, ancestry, paternity). National legislation is currently being developed and Council of Experts in Medical Genetics has issued an opinion about Genetic Testing and Commercialization of Genetic Tests in Slovenia. Despite the fact that Slovenia has signed the Additional protocol to the convention on human rights and biomedicine, concerning genetic testing for health purposes, DTC GT in Slovenia is present and against all international recommendations. There is lack of or no medical supervision, clinical validity and utility of tests and inappropriate genetic testing of minors is available. There is urgent need for regulation of ethical, legal, and social aspects. National legislation on DTC GT is being prepared.
... management time at $134 per hour, 40 to 80 hours of marketing management time at a cost of $88 per hour, and... Management and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section of this document..., or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630...
Sewak, Saurabh S; Wilkin, Noel E; Bentley, John P; Smith, Mickey C
Recent attempts to propose criteria for judging the quality of pharmaceutical and healthcare Web sites do not distinguish between attributes of Web site design related to content and other attributes not related to the content. The Elaboration Likelihood Model from persuasion literature is used as a framework for investigating the effects of Web site design on consequents like attitude and knowledge acquisition. A between-subjects, 2 (high or low involvement)x2 (Web site designed with high or low aspects of visual appeal) factorial design was used in this research. College students were randomly assigned to these treatment groups yielding a balanced design with 29 observations per treatment cell. Analysis of variance results for the effects of involvement and Web site design on attitude and knowledge indicated that the interaction between the independent variables was not significant in both analyses. Examination of main effects revealed that participants who viewed the Web site with higher visual appeal actually had slightly lower knowledge scores (6.32) than those who viewed the Web site with lower visual appeal (7.03, F(1,112)=3.827, P=.053). Results of this research seem to indicate that aspects of Web site design (namely aspects of visual appeal and quality) may not play a role in attaining desired promotional objectives, which can include development of favorable attitudes toward the product and facilitating knowledge acquisition.
Wade, Christopher H; Wilfond, Benjamin S
Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society. Published 2006 Wiley-Liss, Inc.
Zaitsu, Masayoshi; Yoo, Byung-Kwang; Tomio, Jun; Nakamura, Fumiaki; Toyokawa, Satoshi; Kobayashi, Yasuki
Direct-to-consumer information (DTCI) campaign is a new medium to inform and empower patients in their decision-making without directly promoting specific drugs. However, little is known about the impact of DTCI campaigns, expanding rapidly in developed countries, on changes in prescription patterns. We sought to determine whether a DTCI campaign on overactive bladder increases the prescription rate for overactive bladder treatment drugs. We performed a 3-year retrospective cohort study of 1332 participants who were diagnosed overactive bladder but not prescribed treatment drugs prior to the examined DTCI campaign (exposure), using the health insurance claims dataset of the Japan Medical Data Center (November 19, 2010 to November 18, 2013). The DTCI campaign for overactive bladder included television, Internet, and print advertising (November 19, 2011 to December 22, 2011). We divided the study period into Pre-Campaign Year (2010-2011), Year 1 (2011-2012), and Year 2 (2012-2013). Each year began on November 19 and included Period 1 (weeks 1-5) through Period 10 (weeks 46-50). The main outcome was first-time prescription of the treatment drug for each patient, measured by 5-week periods. Using Period 10 in the Pre-Campaign Year as the referent period, we applied the Cox proportional hazard model for each period. Additionally, we performed the interrupted time series analysis (ITSA) for the first-time prescription rate per 5-week period. Following the DTCI campaign, patients were about seven times more likely to receive a first prescription of a treatment drug during Period 4 in Year 1 (hazard ratio 7.09; 95% CI, 2.11-23.8; p-valueimpact on the level of prescription rate (one-time increase in the regression-intercept) that increased by 1128.1 [per standardized 100,000 persons] (p < .05) during Period 4 in Year 1. The examined DTCI campaign appeared to increase the prescription rate among patients with overactive bladder for 15 weeks with a 15-week delay. Clinical
Jalnawala, Nekshan; Wilkin, Noel E
Direct-to-consumer advertising (DTCA) has an influence on patients' perceptions, awareness, and behaviors. Inoculation theory and the model of belief processing provide insights into cognition that stand to increase our understanding of how patients process the information presented in these advertisements and form beliefs about medications. This study was conducted to evaluate the effect of sidedness of appeals and argument types in understanding beliefs that are formed after exposure to advertisements. DTCA and negative experiences were used to study these constructs. A 2 (1-sided vs 2-sided appeals) x 2 (causal vs authoritative arguments) factorial study design was used. A total of 263 undergraduate students were assigned to view 1 of the 4 mock flu-medication advertisements and complete a questionnaire. Subjects were then presented with a negative scenario and were asked to fill out a questionnaire based on the information in the ad and in the negative scenario. The dependent measures included belief change, change in intent to inquire, and standardized price change. Data were analyzed using 2-way analysis of variance. Subjects exposed to 2-sided appeals showed lower belief change, standardized price change, and change in intent to inquire following a negative experience than subjects exposed to 1-sided appeals (Pappeal and argument type on initial belief and initial intent to inquire. Some support for aspects of inoculation theory and theory of belief formation was found. The findings suggest that complying with the "fair-balance" requirement may be beneficial to pharmaceutical marketers as 2-sided appeals increase the tenacity of consumers' beliefs. Higher initial belief and intent to inquire when causal arguments are used in 2-sided promotional messages suggest that use of data to substantiate claims in advertisements may result in enhanced beliefs about the merits of advertised medication.
Apathy, Nate C; Menser, Terri; Keeran, Lindsay M; Ford, Eric W; Harle, Christopher A; Huerta, Timothy R
Direct-to-consumer genetic tests for inherited disease risks have gained recent approvals from the Food and Drug Administration, and interest in these tests has continued to grow. Broad use of these tests coupled with planning and discussion with health providers regarding genetic risks and potential protective behavior changes have been proposed as preventive tools to reduce health disparities and improve equity in health outcomes. However, awareness of direct-to-consumer genetic testing has historically demonstrated differences by education, income, and race; these disparities could jeopardize potential benefits by limiting access and use. The national survey data from the Health Information National Trends Survey was analyzed to understand how overall awareness of direct-to-consumer genetic testing and disparities in awareness across sociodemographic groups have changed since 2007. The findings showed persistent disparities, as well as a widening gap in awareness between Hispanics and non-Hispanic whites (OR 2007 =1.52, OR 2014 =0.58, p change =0.0056), despite overall increases in awareness over time. Given these findings, policies regulating direct-to-consumer genetic tests should prioritize equitable distribution of benefits by including provisions that counteract prevailing disparities in awareness. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
In direct-to-consumer (DTC) genetic testing, laboratory-based genetic services are offered directly to the public without an independent healthcare professional being involved. The committee of the Southern African Society for Human Genetics (SASHG) appeals to the public and clinicians to be cautious when considering ...
Harris, A.; Kelly, S.; Wyatt, S.
Individuals now have access to an increasing number of internet resources offering personal genomics services. As the direct-to-consumer genetic testing (DTC GT) industry expands, critics have called for pre- and post-test genetic counseling to be included with the product. Several genetic testing
Full Text Available Background: Personal genomic tests (PGT offered directly-to-consumers (DTC for complex disease risk assessment have raised several concerns regarding their potential adverse impact. To mitigate worries continuing professional education has been advocated and the central gatekeeper role of family physicians has been highlighted. Nevertheless, to date, only few studies have been published on awareness, involvement and attitudes of primary healthcare providers on DTC marketing of PGT and, to the best of our knowledge, none in Italy.Methods: An exploratory survey to achieve information about knowledge and attitudes towards DTC-PGT of a selected group of family physicians participating to courses on predictive medicine and public health genomics was conducted. Results: A total amount of 114 partially or fully filled questionnaires was obtained. The majority of the primary care providers (68,4% expressed that they are unaware that companies are selling genomic tests directly to consumers, while 31,6% was aware. In terms of attitudes toward testing 61,1% of the aware respondents deemed the DTC-PGT for chronic complex diseases to be ‘‘not clinically useful.’’ The overwhelming majority of our respondents (95,6% felt unprepared to answer patients’ questions on DTC-PGT. If only aware respondents are considered this percentage results obviously lower (86,1%, though still very high. Conclusion: The low percentage of aware respondents suggests that DTC advertising in the realm of genomic testing is still limited in Italy. Should DTC-PGT become more widely used, a comprehensive education program may be necessary to increase family physicians’ awareness and help them discuss testing with their patients.
Schaper, Manuel; Schicktanz, Silke
Commercial genetic testing offered over the internet, known as direct-to-consumer genetic testing (DTC GT), currently is under ethical attack. A common critique aims at the limited validation of the tests as well as the risk of psycho-social stress or adaption of incorrect behavior by users triggered by misleading health information. Here, we examine in detail the specific role of advertising communication of DTC GT companies from a medical ethical perspective. Our argumentative analysis departs from the starting point that DTC GT operates at the intersection of two different contexts: medicine on the one hand and the market on the other. Both fields differ strongly with regard to their standards of communication practices and the underlying normative assumptions regarding autonomy and responsibility. Following a short review of the ethical contexts of medical and commercial communication, we provide case examples for persuasive messages of DTC GT websites and briefly analyze their design with a multi-modal approach to illustrate some of their problematic implications. We observe three main aspects in DTC GT advertising communication: (1) the use of material suggesting medical professional legitimacy as a trust-establishing tool, (2) the suggestion of empowerment as a benefit of using DTC GT services and (3) the narrative of responsibility as a persuasive appeal to a moral self-conception. While strengthening and respecting the autonomy of a patient is the focus in medical communication, specifically genetic counselling, persuasive communication is the normal mode in marketing of consumer goods, presuming an autonomous, rational, independent consumer. This creates tension in the context of DTC GT regarding the expectation and normative assessment of communication strategies. Our analysis can even the ground for a better understanding of ethical problems associated with intersections of medical and commercial communication and point to perspectives of analysis of
Niemiec, Emilia; Kalokairinou, Louiza; Howard, Heidi Carmen
A variety of health-related genetic testing is currently advertized directly to consumers. This article provides a timely overview of direct-to-consumer genetic testing (DTC GT) and salient ethical issues, as well as an analysis of the impact of the recently adopted regulation on in vitro diagnostic medical devices on DTC GT. DTC GT companies currently employ new testing approaches, report on a wide spectrum of conditions and target new groups of consumers. Such activities raise ethical issues including the questionable analytic and clinical validity of tests, the adequacy of informed consent, potentially misleading advertizing, testing in children, research uses and commercialization of genomic data. The recently adopted regulation on in vitro diagnostic medical devices may limit the offers of predisposition DTC GT in the EU market.
Ducournau, Pascal; Gourraud, Pierre-Antoine; Rial-Sebbag, Emmanuelle; Bulle, Alexandre; Cambon-Thomsen, Anne
We probably did not anticipate all the consequences of the direct to consumer genetic tests on Internet, resulting from the combined skills of communication and genomic advances. What are the commercial strategies used by the companies offering direct-to-consumer genetic tests on Internet and what are the different social expectations on which they focus? Through a quantitative and qualitative analysis of the web sites offering such tests, it seems that these companies target a triple market based on: the "healthism" which raises health and hygiene to the top of the social values; the contemporary demands of the users to become actual actors of health decisions; and finally on the need for bio-social relationships. These three commercial strategies underlie various ethical and societal issues justifying a general analysis.
Manchaiah, Vinaya; Taylor, Brian; Dockens, Ashley L; Tran, Nicole R; Lane, Kayla; Castle, Mariana; Grover, Vibhu
Background This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1) personal sound amplification products (PSAPs), 2) direct-mail hearing aids, and 3) over-the-counter (OTC) hearing aids. Method A literature review was conducted using EBSCOhost and included the databases CINAHL, MEDLINE, and PsycINFO. After applying prior agreed inclusion and exclusion criteria, 13 reports were included in the review. Results Included studies fell into three domains: 1) electroacoustic characteristics, 2) consumer surveys, and 3) outcome evaluations. Electroacoustic characteristics of these devices vary significantly with some meeting the stringent acoustic criteria used for hearing aids, while others producing dangerous output levels (ie, over 120-dB sound pressure level). Low-end (or low-cost) devices were typically poor in acoustic quality and did not meet gain levels necessary for most adult and elderly hearing loss patterns (eg, presbycusis), especially in high frequencies. Despite direct-mail hearing aids and PSAPs being associated with lower satisfaction when compared to hearing aids purchased through hearing health care professionals, consumer surveys suggest that 5%–19% of people with hearing loss purchase hearing aids through direct-mail or online. Studies on outcome evaluation suggest positive outcomes of OTC devices in the elderly population. Of note, OTC outcomes appear better when a hearing health care professional supports these users. Conclusion While some direct-to-consumer hearing devices have the capability to produce adverse effects due to production of dangerously high sound levels and internal noise, the existing literature suggests that there are potential benefits of these devices. Research of direct-to-consumer hearing devices is limited, and current published studies are of weak quality. Much
Full Text Available Vinaya Manchaiah,1–4 Brian Taylor,5 Ashley L Dockens,1 Nicole R Tran,1 Kayla Lane,1 Mariana Castle,1 Vibhu Grover1 1Department of Speech and Hearing Sciences, Lamar University, Beaumont, TX, USA; 2The Swedish Institute for Disability Research, Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden; 3Audiology India, Mysore, 4Department of Speech and Hearing, School of Allied Health Sciences, Manipal University, Manipal, India; 5Taylor Audio LLC, Minneapolis, MN, USA Background: This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1 personal sound amplification products (PSAPs, 2 direct-mail hearing aids, and 3 over-the-counter (OTC hearing aids.Method: A literature review was conducted using EBSCOhost and included the databases CINAHL, MEDLINE, and PsycINFO. After applying prior agreed inclusion and exclusion criteria, 13 reports were included in the review.Results: Included studies fell into three domains: 1 electroacoustic characteristics, 2 consumer surveys, and 3 outcome evaluations. Electroacoustic characteristics of these devices vary significantly with some meeting the stringent acoustic criteria used for hearing aids, while others producing dangerous output levels (ie, over 120-dB sound pressure level. Low-end (or low-cost devices were typically poor in acoustic quality and did not meet gain levels necessary for most adult and elderly hearing loss patterns (eg, presbycusis, especially in high frequencies. Despite direct-mail hearing aids and PSAPs being associated with lower satisfaction when compared to hearing aids purchased through hearing health care professionals, consumer surveys suggest that 5%–19% of people with hearing loss purchase hearing aids through direct-mail or online. Studies on outcome evaluation suggest positive
Howard, Heidi Carmen; Borry, Pascal
Over the last couple of years, many commercial companies, the majority of which are based in the USA, have been advertising and offering direct-to-consumer (DTC) genetic testing services outside of the established health care system, and often without any involvement from a health care professional. In the last year, however, a number of DTC genetic testing companies have changed their provision model such that consumers must now contact a health care professional before being able to order the genetic testing service. In discussing the advent of this new model of service provision, this article also reviews the ethical and social issues surrounding DTC genetic testing and addresses the potential motivations for change, some barriers to achieving truly appropriate medical supervision and the present reality of DTC genetic testing for some psychiatric and neurological disorders. Since the advent of these commercial activities, critics have pointed a finger at the lack of medical supervision surrounding these services. The discussion herein, however, reveals how difficult it may be, despite the addition of a physician, to actually achieve adequate medical supervision within the present context of DTC genetic testing.
Mahon, Suzanne M
Using direct-to-consumer genetic testing (DTCGT), individuals can order a genetic test, collect and submit a saliva sample, and obtain results about their genetic risk for a variety of traits and health conditions without involving a healthcare provider. Potential benefits of DTCGT include personal control over genetic information and health management decisions, whereas potential risks include misinterpretation of results, psychosocial distress, and lack of informed consent. Oncology nurses can provide education, support, and advocacy to enable patients to truly understand the positives and negatives associated with DTCGT. .
Caulfield, Timothy; McGuire, Amy L
Direct-to-consumer (DTC) genetic testing has attracted a great amount of attention from policy makers, the scientific community, professional groups, and the media. Although it is unclear what the public demand is for these services, there does appear to be public interest in personal genetic risk information. As a result, many commentators have raised a variety of social, ethical, and regulatory issues associated with this emerging industry, including privacy issues, ensuring that DTC companies provide accurate information about the risks and limitations of their services, the possible adverse impact of DTC genetic testing on healthcare systems, and concern about how individuals may interpret and react to genetic risk information.
Egilman, David; Druar, Nicholas M
We describe the emerging issues related to warnings with respect to pharmaceutical company use of the internet as a vehicle for direct-to-consumer marketing (DTC) and market research. We describe the various techniques pharmaceutical companies have used to exploit this new communications medium which permits two way exchange of information. The Food and Drug Administration (FDA) has not issued any specific regulations to control internet based misbranding. We describe some examples of the FDA's application of historic regulations to pharmaceutical company use of this new medium and suggest.
Master, Z; Fu, W; Paciulli, D; Sipp, D
The direct-to-consumer marketing of unproven stem cell interventions (SCIs) is a serious public health concern. Regulations and education have had modest impact, indicating that different actors must play a role to stop this unfettered market. We consider the role of the biotech industry in tackling unproven SCIs. Grounded in the concept of corporate social responsibility, we argue that biotech companies should screen consumers to ensure that products and services are being used appropriately and educate employees about unproven SCIs. © 2017 ASCPT.
Friedberg, Robert D; Bayar, Hasan
The emergence of evidence-based psychological treatments (EVPTs) is a scientific success story, but unfortunately the application of these empirically supported procedures has been slow to gain ground in treatment-as-usual settings. This Open Forum commentary argues that direct-to-consumer (DTC) marketing, which has worked well in communicating the advantages of various medicines, should perhaps be considered for use in social marketing of EVPTs. DTC marketing of pharmaceuticals is a long-standing advertising strategy in the United States. In fact, DTC marketing of psychotropic medicines is quite a success story. The authors recommend various strategies for using marketing science to devise DTC advertising of EVPTs, discuss previous research on DTC campaigns, and describe initiatives launched in the United Kingdom and Europe to promote EVPTs. Suggestions for evaluating and regulating DTC marketing of EVPTs are included. Finally, the potential for DTC marketing of EVPTs to increase mental health literacy and reduce health disparities is explored.
Lee, Sandra Soo-Jin; Vernez, Simone L; Ormond, K E; Granovetter, Mark
Little is known about how consumers of direct-to-consumer personal genetic services share personal genetic risk information. In an age of ubiquitous online networking and rapid development of social networking tools, understanding how consumers share personal genetic risk assessments is critical in the development of appropriate and effective policies. This exploratory study investigates how consumers share personal genetic information and attitudes towards social networking behaviors. Adult participants aged 23 to 72 years old who purchased direct-to-consumer genetic testing from a personal genomics company were administered a web-based survey regarding their sharing activities and social networking behaviors related to their personal genetic test results. 80 participants completed the survey; of those, 45% shared results on Facebook and 50.9% reported meeting or reconnecting with more than 10 other individuals through the sharing of their personal genetic information. For help interpreting test results, 70.4% turned to Internet websites and online sources, compared to 22.7% who consulted their healthcare providers. Amongst participants, 51.8% reported that they believe the privacy of their personal genetic information would be breached in the future. Consumers actively utilize online social networking tools to help them share and interpret their personal genetic information. These findings suggest a need for careful consideration of policy recommendations in light of the current ambiguity of regulation and oversight of consumer initiated sharing activities.
I sketch a libertarian argument for the right to test in the context of 'direct to consumer' (DTC) genetic testing. A libertarian right to genetic tests, as defined here, relies on the idea of a moral right to self-ownership. I show how a libertarian right to test can be inferred from this general libertarian premise, at least as a prima facie right, shifting the burden of justification on regulators. I distinguish this distinctively libertarian position from some arguments based on considerations of utility or autonomy, which are sometimes labelled 'libertarian' because they oppose a tight regulation of the direct to consumer genetic testing sector. If one takes the libertarian right to test as a starting point, the whole discussion concerning autonomy and personal utility may be sidestepped. Finally, I briefly consider some considerations that justify the regulation of the DTC genetic testing market, compatible with the recognition of a prima facie right to test. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Full Text Available Little is known about how consumers of direct-to-consumer personal genetic services share personal genetic risk information. In an age of ubiquitous online networking and rapid development of social networking tools, understanding how consumers share personal genetic risk assessments is critical in the development of appropriate and effective policies. This exploratory study investigates how consumers share personal genetic information and attitudes towards social networking behaviors. Methods: Adult participants aged 23 to 72 years old who purchased direct-to-consumer genetic testing from a personal genomics company were administered a web-based survey regarding their sharing activities and social networking behaviors related to their personal genetic test results. Results: 80 participants completed the survey; of those, 45% shared results on Facebook and 50.9% reported meeting or reconnecting with more than 10 other individuals through the sharing of their personal genetic information. For help interpreting test results, 70.4% turned to Internet websites and online sources, compared to 22.7% who consulted their healthcare providers. Amongst participants, 51.8% reported that they believe the privacy of their personal genetic information would be breached in the future. Conclusion: Consumers actively utilize online social networking tools to help them share and interpret their personal genetic information. These findings suggest a need for careful consideration of policy recommendations in light of the current ambiguity of regulation and oversight of consumer initiated sharing activities.
Gray, Kathleen; Stephen, Remya; Terrill, Bronwyn; Wilson, Brenda; Middleton, Anna; Tytherleigh, Rigan; Turbitt, Erin; Gaff, Clara; Savard, Jacqueline; Hickerton, Chriselle; Newson, Ainsley; Metcalfe, Sylvia
This paper uses consumer health informatics as a framework to explore whether and how direct-to-consumer personal genomic testing can be regarded as a form of information which assists consumers to manage their health. It presents findings from qualitative content analysis of web sites that offer testing services, and of transcripts from focus groups conducted as part a study of the Australian public's expectations of personal genomics. Content analysis showed that service offerings have some features of consumer health information but lack consistency. Focus group participants were mostly unfamiliar with the specifics of test reports and related information services. Some of their ideas about aids to knowledge were in line with the benefits described on provider web sites, but some expectations were inflated. People were ambivalent about whether these services would address consumers' health needs, interests and contexts and whether they would support consumers' health self-management decisions and outcomes. There is scope for consumer health informatics approaches to refine the usage and the utility of direct-to-consumer personal genomic testing. Further research may focus on how uptake is affected by consumers' health literacy or by services' engagement with consumers about what they really want.
Three to four million individuals struggle with obsessive-compulsive disorder (OCD) in the United States at any given time. OCD can be a debilitating disorder associated with significant quality-of-life and occupational impairment. First-line treatments for OCD (selective serotonin reuptake inhibitors and exposure and response prevention therapy) have been shown to be effective; yet, many individuals suffering from OCD experience multiple barriers to accessing these treatments. In fact, it can take as many as 17 years from onset of symptoms to effective treatment. Given the need to increase access to and utilization of effective treatments, direct-to-consumer marketing in the context of OCD appears crucial. The International OCD Foundation (formerly the Obsessive Compulsive Foundation) was established as a nonprofit organization with a mission to educate the public and mental health professionals about appropriate practice guidelines, raise awareness of the disorder, and ensure that individuals looking for treatment find the necessary resources. This paper reviews the obstacles those struggling with OCD face in their attempts to alleviate suffering, as well as the direct-to-consumer strategies and tactics used by the International OCD Foundation to improve access to empirically supported, effective treatment. Copyright Â© 2011. Published by Elsevier Ltd.
Gollust, Sarah E; Wilfond, Benjamin S; Hull, Sara Chandros
PURPOSE The increasing use of the Internet to obtain genetics information and to order medical services without a prescription, combined with a rise in direct-to-consumer marketing for genetic testing, suggests the potential for the Internet to be used to sell genetic services. METHODS A systematic World Wide Web search was conducted in May 2002 to assess the availability of genetic services sold directly to consumers on the Internet. RESULTS Out of 105 sites that offered genetic services directly, most offered non-health-related services, including parentage confirmation testing (83%), identity testing (56%), and DNA banking (24%); however, health-related genetic tests were offered through 14 sites (13%). The health-related genetic tests available ranged from standard tests, such as hemochromatosis and cystic fibrosis, to more unconventional tests related to nutrition, behavior, and aging. Of these 14 sites, 5 described risks associated with the genetic services and 6 described the availability of counseling. CONCLUSIONS The availability of direct sales of health-related genetic tests creates the potential for inadequate pretest decision making, misunderstanding test results, and access to tests of questionable clinical value.
Mirkin, Joshua N; Lowrance, William T; Feifer, Andrew H; Mulhall, John P; Eastham, James E; Elkin, Elena B
Robotic surgery to remove a cancerous prostate has become a popular treatment. Internet marketing of this surgery provides an intriguing case study of direct-to-consumer promotions of medical devices, which are more loosely regulated than pharmaceutical promotions. We investigated whether the claims made in online promotions of robotic prostatectomy were consistent with evidence from comparative effectiveness studies. After performing a search and cross-sectional analysis of websites that mentioned the procedure, we found that many sites claimed benefits that were unsupported by evidence and that 42 percent of the sites failed to mention risks. Most sites were published by hospitals and physicians, which the public may regard as more objective than pages published by manufacturers. Unbalanced information may inappropriately raise patients' expectations. Increasing enforcement and regulation of online promotions may be beyond the capabilities of federal authorities. Thus, the most feasible solution may be for the government and medical societies to promote the production of balanced educational material.
Varga, Elizabeth A
As a genetic counselor, I had mixed opinions when my mother told me of her intent to undergo genomewide, SNP-based direct-to-consumer (DTC) genetic testing. I cautioned her that results could be misleading, could increase anxiety and were often of limited clinical validity or utility. I warned of the possibility of learning unintended health information and expressed concerns about how the information might be used by a private company. I told her about the variability in results among companies. Yet, she persisted in her desire, reminding me that she was an informed consumer. After reviewing her goals and understanding of the information she might receive, she elected to proceed. Despite my insistence that I would not be her personal genetic counselor, when the results came back, I found myself immersed in her genetic data. In this manuscript, I will examine how this personal experience challenged my perceptions of DTC testing.
Mirkin, Joshua N.; Lowrance, William T.; Feifer, Andrew H.; Mulhall, John P.; Eastham, James E.; Elkin, Elena B.
Robotic surgery to remove a cancerous prostate has become a popular treatment. Internet marketing of this surgery provides an intriguing case study of direct-to-consumer promotions of medical devices, which are more loosely regulated than pharmaceutical promotions. We investigated whether the claims made in online promotions of robotic prostatectomy were consistent with evidence from comparative effectiveness studies. After performing a search and crosssectional analysis of websites that mentioned the procedure, we found that many sites claimed benefits that were unsupported by evidence and that 42 percent of the sites failed to mention risks. Most sites were published by hospitals and physicians, which the public may regard as more objective than pages published by manufacturers. Unbalanced information may inappropriately raise patients’ expectations. Increasing enforcement and regulation of online promotions may be beyond the capabilities of federal authorities. Thus, the most feasible solution may be for the government and medical societies to promote the production of balanced educational material. PMID:22492893
Santucci, Lauren C; McHugh, R Kathryn; Barlow, David H
The dissemination and implementation of evidence-based psychological interventions (EBPIs) to service provision settings has been a major challenge. Most efforts to disseminate and implement EBPIs have focused on clinicians and clinical systems as the consumers of these treatments and thus have targeted efforts to these groups. An alternative, complementary approach to achieve more widespread utilization of EBPIs is to disseminate directly to patients themselves. The aim of this special section is to explore several direct-to-consumer (i.e., patient) dissemination and education efforts currently underway. This manuscript highlights the rationale for direct-to-patient dissemination strategies as well as the application of marketing science to dissemination efforts. Achieving greater access to EBPIs will require the use of multiple approaches to overcome the many and varied barriers to successful dissemination and implementation. Copyright Â© 2011. Published by Elsevier Ltd.
Roberts, J Scott; Gornick, Michele C; Carere, Deanna Alexis; Uhlmann, Wendy R; Ruffin, Mack T; Green, Robert C
To describe the interests, decision making, and responses of consumers of direct-to-consumer personal genomic testing (DTC-PGT) services. Prior to 2013 regulatory restrictions on DTC-PGT services, 1,648 consumers from 2 leading companies completed Web surveys before and after receiving test results. Prior to testing, DTC-PGT consumers were as interested in ancestry (74% very interested) and trait information (72%) as they were in disease risks (72%). Among disease risks, heart disease (68% very interested), breast cancer (67%), and Alzheimer disease (66%) were of greatest interest prior to testing. Interest in disease risks was associated with female gender and poorer self-reported health (p decisions. © 2017 S. Karger AG, Basel.
Huang, Yi; Labiner-Wolfe, Judith; Huang, Hui; Choiniere, Conrad J; Fein, Sara B
Infant formula is marketed by health professionals and directly to consumers. Formula marketing has been shown to reduce breastfeeding, but the relation with switching formulas has not been studied. Willingness to switch formula can enable families to spend less on formula. Data are from the Infant Feeding Practices Study II, a United States national longitudinal study. Mothers were asked about media exposure to formula information during pregnancy, receiving formula samples or coupons at hospital discharge, reasons for their formula choice at infant age 1 month, and formula switching at infant ages 2, 5, 7, and 9 months. Analysis included 1,700 mothers who fed formula at infant age 1 month; it used logistic regression and longitudinal data analysis methods to evaluate the association between marketing and formula choice and switching. Most mothers were exposed to both types of formula marketing. Mothers who received a sample of formula from the hospital at birth were more likely to use the hospital formula 1 month later. Mothers who chose formula at 1 month because their doctor recommended it were less likely to switch formula than those who chose in response to direct-to-consumer marketing. Mothers who chose a formula because it was used in the hospital were less likely to switch if they had not been exposed to Internet web-based formula information when pregnant or if they received a formula sample in the mail. Marketing formula through health professionals may decrease mothers' willingness to switch formula. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.
Sydney is Australia’s advertising capital and the relationship between the city and the advertising industry stretches back to the earliest years of European settlement. Advertising helped propel commercial activity in Sydney and the advertising industry has been no less active in shaping Sydney, illuminating the city’s skyline and streetscape, and influencing the lives of all Sydneysiders – from suburban consumers to esteemed artists. Moreover, advertising has promoted the city itself as a ...
Covolo, Loredana; Rubinelli, Sara; Ceretti, Elisabetta; Gelatti, Umberto
Direct-to-consumer genetic tests (DTC-GT) are easily purchased through the Internet, independent of a physician referral or approval for testing, allowing the retrieval of genetic information outside the clinical context. There is a broad debate about the testing validity, their impact on individuals, and what people know and perceive about them. The aim of this review was to collect evidence on DTC-GT from a comprehensive perspective that unravels the complexity of the phenomenon. A systematic search was carried out through PubMed, Web of Knowledge, and Embase, in addition to Google Scholar according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist with the key term "Direct-to-consumer genetic test." In the final sample, 118 articles were identified. Articles were summarized in five categories according to their focus on (1) knowledge of, attitude toward use of, and perception of DTC-GT (n=37), (2) the impact of genetic risk information on users (n=37), (3) the opinion of health professionals (n=20), (4) the content of websites selling DTC-GT (n=16), and (5) the scientific evidence and clinical utility of the tests (n=14). Most of the articles analyzed the attitude, knowledge, and perception of DTC-GT, highlighting an interest in using DTC-GT, along with the need for a health care professional to help interpret the results. The articles investigating the content analysis of the websites selling these tests are in agreement that the information provided by the companies about genetic testing is not completely comprehensive for the consumer. Given that risk information can modify consumers' health behavior, there are surprisingly few studies carried out on actual consumers and they do not confirm the overall concerns on the possible impact of DTC-GT. Data from studies that investigate the quality of the tests offered confirm that they are not informative, have little predictive power, and do not measure genetic risk
Shaer, Orit; Nov, Oded; Okerlund, Johanna; Balestra, Martina; Stowell, Elizabeth; Ascher, Laura; Bi, Joanna; Schlenker, Claire; Ball, Madeleine
In recent years, people who sought direct-to-consumer genetic testing services have been increasingly confronted with an unprecedented amount of personal genomic information, which influences their decisions, emotional state, and well-being. However, these users of direct-to-consumer genetic services, who vary in their education and interests, frequently have little relevant experience or tools for understanding, reasoning about, and interacting with their personal genomic data. Online interactive techniques can play a central role in making personal genomic data useful for these users. We sought to (1) identify the needs of diverse users as they make sense of their personal genomic data, (2) consequently develop effective interactive visualizations of genomic trait data to address these users' needs, and (3) evaluate the effectiveness of the developed visualizations in facilitating comprehension. The first two user studies, conducted with 63 volunteers in the Personal Genome Project and with 36 personal genomic users who participated in a design workshop, respectively, employed surveys and interviews to identify the needs and expectations of diverse users. Building on the two initial studies, the third study was conducted with 730 Amazon Mechanical Turk users and employed a controlled experimental design to examine the effectiveness of different design interventions on user comprehension. The first two studies identified searching, comparing, sharing, and organizing data as fundamental to users' understanding of personal genomic data. The third study demonstrated that interactive and visual design interventions could improve the understandability of personal genomic reports for consumers. In particular, results showed that a new interactive bubble chart visualization designed for the study resulted in the highest comprehension scores, as well as the highest perceived comprehension scores. These scores were significantly higher than scores received using the
Rubinelli, Sara; Ceretti, Elisabetta; Gelatti, Umberto
Background Direct-to-consumer genetic tests (DTC-GT) are easily purchased through the Internet, independent of a physician referral or approval for testing, allowing the retrieval of genetic information outside the clinical context. There is a broad debate about the testing validity, their impact on individuals, and what people know and perceive about them. Objective The aim of this review was to collect evidence on DTC-GT from a comprehensive perspective that unravels the complexity of the phenomenon. Methods A systematic search was carried out through PubMed, Web of Knowledge, and Embase, in addition to Google Scholar according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist with the key term “Direct-to-consumer genetic test.” Results In the final sample, 118 articles were identified. Articles were summarized in five categories according to their focus on (1) knowledge of, attitude toward use of, and perception of DTC-GT (n=37), (2) the impact of genetic risk information on users (n=37), (3) the opinion of health professionals (n=20), (4) the content of websites selling DTC-GT (n=16), and (5) the scientific evidence and clinical utility of the tests (n=14). Most of the articles analyzed the attitude, knowledge, and perception of DTC-GT, highlighting an interest in using DTC-GT, along with the need for a health care professional to help interpret the results. The articles investigating the content analysis of the websites selling these tests are in agreement that the information provided by the companies about genetic testing is not completely comprehensive for the consumer. Given that risk information can modify consumers’ health behavior, there are surprisingly few studies carried out on actual consumers and they do not confirm the overall concerns on the possible impact of DTC-GT. Data from studies that investigate the quality of the tests offered confirm that they are not informative, have little predictive
Borry, Pascal; van Hellemondt, Rachel E; Sprumont, Dominique; Jales, Camilla Fittipaldi Duarte; Rial-Sebbag, Emmanuelle; Spranger, Tade Matthias; Curren, Liam; Kaye, Jane; Nys, Herman; Howard, Heidi
An increasing number of private companies are now offering direct-to-consumer (DTC) genetic testing services. Although a lot of attention has been devoted to the regulatory framework of DTC genetic testing services in the USA, only limited information about the regulatory framework in Europe is available. We will report on the situation with regard to the national legislation on DTC genetic testing in seven European countries (Belgium, the Netherlands, Switzerland, Portugal, France, Germany, the United Kingdom). The paper will address whether these countries have legislation that specifically address the issue of DTC genetic testing or have relevant laws that is pertinent to the regulatory control of these services in their countries. The findings show that France, Germany, Portugal and Switzerland have specific legislation that defines that genetic tests can only be carried out by a medical doctor after the provision of sufficient information concerning the nature, meaning and consequences of the genetic test and after the consent of the person concerned. In the Netherlands, some DTC genetic tests could fall under legislation that provides the Minister the right to refuse to provide a license to operate if a test is scientifically unsound, not in accordance with the professional medical practice standards or if the expected benefit is not in balance with the (potential) health risks. Belgium and the United Kingdom allow the provision of DTC genetic tests.
Hawkins, Alice K; Ho, Anita
Over the last several years, direct to consumer(DTC) genetic testing has received increasing attention in the public, healthcare and academic realms. DTC genetic testing companies face considerable criticism and scepticism,particularly from the medical and genetic counseling community. This raises the question of what specific aspects of DTC genetic testing provoke concerns, and conversely,promises, for genetic counselors. This paper addresses this question by exploring DTC genetic testing through an ethic allens. By considering the fundamental ethical approaches influencing genetic counseling (the ethic of care and principle-based ethics) we highlight the specific ethical concerns raised by DTC genetic testing companies. Ultimately,when considering the ethics of DTC testing in a genetic counseling context, we should think of it as a balancing act. We need careful and detailed consideration of the risks and troubling aspects of such testing, as well as the potentially beneficial direct and indirect impacts of the increased availability of DTC genetic testing. As a result it is essential that genetic counselors stay informed and involved in the ongoing debate about DTC genetic testing and DTC companies. Doing so will ensure that the ethical theories and principles fundamental to the profession of genetic counseling are promoted not just in traditional counseling sessions,but also on a broader level. Ultimately this will help ensure that the public enjoys the benefits of an increasingly genetic based healthcare system.
Sullivan, Helen W; Aikin, Kathryn J; Poehlman, Jon
Direct-to-consumer (DTC) television ads for prescription drugs are required to disclose the product's major risks in the audio or audio and visual parts of the presentation (sometimes referred to as the "major statement"). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks' severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.
Webborn, Nick; Williams, Alun; McNamee, Mike; Bouchard, Claude; Pitsiladis, Yannis; Ahmetov, Ildus; Ashley, Euan; Byrne, Nuala; Camporesi, Silvia; Collins, Malcolm; Dijkstra, Paul; Eynon, Nir; Fuku, Noriyuki; Garton, Fleur C; Hoppe, Nils; Holm, Søren; Kaye, Jane; Klissouras, Vassilis; Lucia, Alejandro; Maase, Kamiel; Moran, Colin; North, Kathryn N; Pigozzi, Fabio; Wang, Guan
The general consensus among sport and exercise genetics researchers is that genetic tests have no role to play in talent identification or the individualised prescription of training to maximise performance. Despite the lack of evidence, recent years have witnessed the rise of an emerging market of direct-to-consumer marketing (DTC) tests that claim to be able to identify children's athletic talents. Targeted consumers include mainly coaches and parents. There is concern among the scientific community that the current level of knowledge is being misrepresented for commercial purposes. There remains a lack of universally accepted guidelines and legislation for DTC testing in relation to all forms of genetic testing and not just for talent identification. There is concern over the lack of clarity of information over which specific genes or variants are being tested and the almost universal lack of appropriate genetic counselling for the interpretation of the genetic data to consumers. Furthermore independent studies have identified issues relating to quality control by DTC laboratories with different results being reported from samples from the same individual. Consequently, in the current state of knowledge, no child or young athlete should be exposed to DTC genetic testing to define or alter training or for talent identification aimed at selecting gifted children or adolescents. Large scale collaborative projects, may help to develop a stronger scientific foundation on these issues in the future. PMID:26582191
Bollinger, Juli Murphy; Green, Robert C; Kaufman, David
The first regulatory rulings by the U.S. Food and Drug Administration on direct-to-consumer (DTC) genetic testing services are expected soon. As the process of regulating these and other genetic tests moves ahead, it is important to understand the preferences of DTC genetic testing customers about the regulation of these products. An online survey of customers of three DTC genetic testing companies was conducted 2-8 months after they had received their results. Participants were asked about the importance of regulating the companies selling DTC genetic tests. Most of the 1,046 respondents responded that it would be important to have a nongovernmental (84%) or governmental agency (73%) monitor DTC companies' claims to ensure the consistency with scientific evidence. However, 66% also felt that it was important that DTC tests be available without governmental oversight. Nearly, all customers favored a policy to ensure that insurers and law enforcement officials could not access their information. Although many DTC customers want access to genetic testing services without restrictions imposed by the government regulation, most also favor an organization operating alongside DTC companies that will ensure that the claims made by the companies are consistent with sound scientific evidence. This seeming contradiction may indicate that DTC customers want to ensure that they have unfettered access to high-quality information. Additionally, policies to help ensure privacy of data would be welcomed by customers, despite relatively high confidence in the companies.
Harris, Anna; Kelly, Susan E.; Wyatt, Sally
Despite a growing personal genomics market, little is known about how people engage with the possibilities offered by direct-to-consumer (DTC) genetic testing. In order to help address this gap, this study deploys narrative analysis of YouTube videos posted by individuals who have purchased DTC genetic testing for disease. Genetic testing is said to be contributing to new states of illness, where individuals may become “patients-in-waiting.” In the videos analyzed, we found a new form of storytelling about this ambiguous state of illness, which we refer to as autobiology. Autobiology – the study of, and story about, one's own biology – concerns narratives of sense-making through forms of biological practice, as well as wayfaring narratives which interweave genetic markers and family histories of disease. These autobiologies – part of a broader shift toward public stories about genetics and other healthcare technologies – exhibit playfulness, as well as being bound with consumerist practices. PMID:24772003
Zawati, Ma'n H; Borry, Pascal; Howard, Heidi Carmen
Genetic research gained new momentum with the completion of the Human Genome Project in 2003. Formerly centered on the investigation of single-gene disorders, genetic research is increasingly targeting common complex diseases and in doing so is studying the whole genome, the environment and its impact on genomic variation. Consequently, biobanking initiatives have emerged around the world as a tool to sustain such progress. Whether they are small scale or longitudinal, public or private, commercial or non-commercial, biobanks should consider the possibility of closure. Interestingly, while raising important ethical issues, this topic has hardly been explored in the literature. Indeed, ethical issues associated with sale, insolvency, end of funding, or transfer of materials to other entities (which are all issues either related to or possible consequences of closure) are seldom the subject of discussion. In an attempt to fill this gap, this paper will discuss-using population and direct-to-consumer (DTC) genetic testing companies' biobanks as case studies-(1) international and national normative documents addressing the issue of closure and (2) the internal policies of population biobanks and DTC genetic testing companies. The analysis will inform the debate on biobank closure and elucidate the underlying ethical issues, which include, but are not limited to informed consent, storage and privacy.
Martinez-Martin, Nicole; Kreitmair, Karola
This paper focuses on the ethical challenges presented by direct-to-consumer (DTC) digital psychotherapy services that do not involve oversight by a professional mental health provider. DTC digital psychotherapy services can potentially assist in improving access to mental health care for the many people who would otherwise not have the resources or ability to connect with a therapist. However, the lack of adequate regulation in this area exacerbates concerns over how safety, privacy, accountability, and other ethical obligations to protect an individual in therapy are addressed within these services. In the traditional therapeutic relationship, there are ethical obligations that serve to protect the interests of the client and provide warnings. In contrast, in a DTC therapy app, there are no clear lines of accountability or associated ethical obligations to protect the user seeking mental health services. The types of DTC services that present ethical challenges include apps that use a digital platform to connect users to minimally trained nonprofessional counselors, as well as services that provide counseling steered by artificial intelligence and conversational agents. There is a need for adequate oversight of DTC nonprofessional psychotherapy services and additional empirical research to inform policy that will provide protection to the consumer. ©Nicole Martinez-Martin, Karola Kreitmair. Originally published in JMIR Mental Health (http://mental.jmir.org), 23.04.2018.
Bowen, D J; Harris, J; Jorgensen, C M; Myers, M F; Kuniyuki, A
Direct-to-consumer marketing of genetic tests is beginning to appear in select markets, and little independent evaluation has been conducted on the effects of this marketing on consumer attitudes or behavior. The purpose of this paper is to identify the effects of socioeconomic status on women's reactions to such a campaign, including knowledge of the test, perceptions of personal risk, communications with others about the test, and interest in pursuing the test. The only United States provider of genetic testing for breast and ovarian cancer susceptibility (BRCA1/2 testing) conducted a pilot marketing campaign that targeted women aged 25-54 and their health care providers in 2 cities, Atlanta, Ga., and Denver, Colo. The design for the evaluation was a post campaign consumer survey, based on a cross-sectional stratified random sample of women in the 2 intervention sites and 2 comparison sites. The campaign had no differential impact by socioeconomic status. However, there was a consistent relationship between socioeconomic status and several outcome variables, including knowledge of the test, beliefs about the test, and desire to know about genetic risk. These data indicate that socioeconomic status may play a role in uptake of genetic services, regardless of response to a media campaign. Copyright 2009 S. Karger AG, Basel.
Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H; Clarke, Roberta N; Antony, Martin M
Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Participants (N = 344; 75.0% female, mean age = 18.6 years, 48.5% non-Hispanic White) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were a PT campaign, a PT informing about medication side effects campaign, a medication campaign, and a neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. (c) 2015 APA, all rights reserved).
Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H
Progress disseminating and implementing evidence-based psychological treatments (EBPTs) for the anxiety disorders has been gradual. To date, the dominant approach for promoting the uptake of EBPTs in clinical settings has been to target the education and training of mental health providers, with many consumers remaining unaware of the potential benefits of EBPTs for anxiety disorders. Direct-to-consumer (DTC) marketing may be a promising vehicle for increasing EBPT utilization rates in the treatment of anxiety disorders. This paper provides an overview of the rationale and important considerations for applying DTC efforts to promote evidence-based care in the treatment of anxiety disorders, and reviews current DTC efforts in this area, including resources on the Internet and other media and in-person events. We conclude with recommendations for future efforts in the DTC marketing of EBPTs for the anxiety disorders, including the need for increased funding and grassroots efforts to inform consumers about anxiety disorders and their most effective treatments. Copyright © 2013 Elsevier Ltd. All rights reserved.
Uscher-Pines, Lori; Mulcahy, Andrew; Cowling, David; Hunter, Gerald; Burns, Rachel; Mehrotra, Ateev
Direct-to-consumer (DTC) telemedicine serves millions of patients; however, there is limited research on the care provided. This study compared the quality of care at Teladoc ( www.teladoc.com ), a large DTC telemedicine company, with that at physician offices and compared access to care for Teladoc users and nonusers. Claims from all enrollees 18-64 years of age in the California Public Employees' Retirement System health maintenance organization between April 2012 and October 2013 were analyzed. We compared the performance of Teladoc and physician offices on applicable Healthcare Effectiveness Data and Information Set measures. Using geographic information system analyses, we compared Teladoc users and nonusers with respect to rural location and available primary care physicians. Of enrollees offered Teladoc (n = 233,915), 3,043 adults had a total of 4,657 Teladoc visits. For the pharyngitis performance measure (ordering strep test), Teladoc performed worse than physician offices (3% versus 50%, p located within a healthcare professional shortage area (odds ratio = 1.12, p = 0.10) or rural location (odds ratio = 1.0, p = 0.10). Teladoc providers were less likely to order diagnostic testing and had poorer performance on appropriate antibiotic prescribing for bronchitis. Teladoc users were not preferentially located in underserved communities. Short-term needs include ongoing monitoring of quality and additional marketing and education to increase telemedicine use among underserved patients.
Paquin, Ryan S; Richards, Adam S; Koehly, Laura M; McBride, Colleen M
Varying perspectives exist regarding the implications of genetic susceptibility testing for common disease, with some anticipating adverse effects and others expecting positive outcomes; however, little is known about the characteristics of people who are most likely to be interested in direct-to-consumer genetic testing. To that end, this study examines the association of individual dispositional differences with health risk perceptions and online information seeking related to a free genetic susceptibility test. Healthy adults enrolled in a large health maintenance organization were surveyed by telephone. Eligible participants (N = 1,959) were given access to a secure website that provided risk and benefit information about a genetic susceptibility test and given the option to be tested. Neuroticism was associated with increased perceptions of disease risk but not with logging on. Those scoring high in conscientiousness were more likely to log on. We found no evidence that neuroticism, a dispositional characteristic commonly linked to adverse emotional response, was predictive of online genetic information seeking in this sample of healthy adults.
Direct-to-consumer genetic testing (DTC-GT) has sparked much controversy and undergone dramatic changes in its brief history. Debates over appropriate health policies regarding DTC-GT would benefit from empirical research on its benefits, harms, and limitations. We review the recent literature (2011-present) and summarize findings across (1) content analyses of DTC-GT websites, (2) studies of consumer perspectives and experiences, and (3) surveys of relevant health care providers. Findings suggest that neither the health benefits envisioned by DTC-GT proponents (e.g., significant improvements in positive health behaviors) nor the worst fears expressed by its critics (e.g., catastrophic psychological distress and misunderstanding of test results, undue burden on the health care system) have materialized to date. However, research in this area is in its early stages and possesses numerous key limitations. We note needs for future studies to illuminate the impact of DTC-GT and thereby guide practice and policy regarding this rapidly evolving approach to personal genomics. PMID:24058877
In June 2016, Korea permitted direct-to-consumer genetic testing (DTC-GT) on 42 genes. However, both the market and industry have not yet been fully activated. Considering the aforementioned context, this study provides important insights. The Korean DTC-GT policy assessment is based on consumer preference analysis using a discrete choice experiment. In August 2016, a web-based survey was conducted to collect data from 1,200 respondents. The estimation results show that consumers prefer a DTC-GT product that is cheap, tests various items or genes, offers accurate test results, and guarantees the confidentiality of all information. However, consumers are not entirely satisfied by current DTC-GT products due to the existence of insufficient and/or inadequate policies. First, the permitted testing of 42 genes is insufficient to satisfy consumers' curiosity regarding their genes. Second, the accuracy of the DTC-GT products has not been fully verified, assessed, and communicated to consumers. Finally, regulatory loopholes that allow information leaks in the DTC-GT process can occur. These findings imply that DTC-GT requires an improvement in government policy-making criteria and the implementation of practical measures to guarantee test accuracy and genetic information. © 2017 S. Karger AG, Basel.
Fabius, A Mariette; Cheung, Ka-Chun; Rijcken, Cristianne J F; Vinkers, Christiaan H; Talsma, Herre
Investigation of the current application of direct-to-consumer (DTC) communication on prescription only medicines via the Intemet in the Netherlands. Questionnaires were sent by e-mail to 43 Dutch innovative pharmaceutical industries and 130 Patient Association and Support Groups (PASGs). In this pilot study, the response of the pharmaceutical industry was rather low but the impression is that they were willing to invest in DTC communication. The majority of the websites of PASGs did not link to websites of pharmaceutical companies. The PASGs had no opinion whether patients can make a good distinction between DTC advertising and information on websites of the pharmaceutical industry nor about the quality. PASGs did not think unambiguously about the impact on the patient-doctor relationship. The impact of DTC communication on prescription only medicines via the internet is not yet clear in the Netherlands.
de Paor, Aisling
With rapid scientific and technological advances, the past few years has witnessed the emergence of a new genetic era and a growing understanding of the genetic make-up of human beings. These advances have propelled the introduction of companies offering direct to consumer (DTC) genetic testing, which facilitates the direct provision of such tests to consumers, (for example, via the internet). Although DTC genetic testing offers benefits by enhancing consumer accessibility to such technology, promoting proactive healthcare and increasing genetic awareness, it presents a myriad of challenges, from an ethical, legal and regulatory perspective. As DTC genetic testing usually eliminates the need for a medical professional in accessing genetic tests, this lack of professional guidance and counselling may result in misinterpretation and confusion regarding results. In addition, an evident concern relates to the scientific validity and quality of these tests. A further problem arising is the lack or inadequacy of regulation in this field. Despite the increasing accessibility of DTC genetic testing, this legislative vacuum is apparent in Ireland, where there is no concrete legislation. This article explores the main ethical, legal and regulatory issues arising with the advent of rapid advances in DTC genetic testing in Ireland. Further, with inevitable future advances in genetic science, as well as increasing internet accessibility, the challenges presented are likely to become more amplified. In consideration of the ethical and legal challenges, this paper highlights the regulation of DTC genetic testing as a growing concern in Ireland, recognising its importance to both the scientific community as well as in respect of enhancing consumer confidence in such technologies.
Bonython, Wendy Elizabeth; Arnold, Bruce Baer
Loi recently proposed a libertarian right to direct to consumer genetic testing (DTCGT)- independent of autonomy or utility-reflecting Cohen's work on self-ownership and Hohfeld's model of jural relations. Cohen's model of libertarianism dealt principally with self-ownership of the physical body. Although Loi adequately accounts for the physical properties of DNA, DNA is also an informational substrate, highly conserved within families. Information about the genome of relatives of the person undergoing testing may be extrapolated without requiring direct engagement with their personal physical copy of the genome, triggering rights and interests of relatives that may differ from the rights and interests of others, that is, individual consumers, testing providers and regulators. Loi argued that regulatory interference with exercise of the right required justification, whereas prima facie exercise of the right did not. Justification of regulatory interference could include 'conflict with other people's rights', 'aggressive' use of the genome and 'harming others'. Harms potentially experienced by relatives as a result of the individual's exercise of a right to test include breach of genetic privacy, violation of their right to determine when, and if, they undertake genetic testing and discrimination. Such harms may justify regulatory intervention, in the event they are recognised; motives driving 'aggressive' use of the genome may also be relevant. Each of the above criteria requires clarification, as potential redundancies and tensions exist between them, with different implications affecting different groups of rights holders. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
McGrath, Scott P; Coleman, Jason; Najjar, Lotfollah; Fruhling, Ann; Bastola, Dhundy R
The aim of this study was to evaluate current direct-to-consumer (DTC) genetic customers' ability to interpret and comprehend test results and to determine if honest brokers are needed. One hundred and twenty-two customers of the DTC genetic testing company 23andMe were polled in an online survey. The subjects were asked about their personal test results and to interpret the results of two mock test cases (type 2 diabetes and multiple sclerosis), where results were translated into disease probability for an individual compared to the public. When asked to evaluate the risk, 72.1% correctly assessed the first case and 77% were correct on the second case. Only 23.8% of those surveyed were able to interpret both cases correctly. x03C7;2 and logistic regression were used to interpret the results. Participants who took the time to read the DTC test-provided supplemental material were 3.93 times (p = 0.040) more likely to correctly interpret the test results than those who did not. The odds for correctly interpreting the test cases were 3.289 times (p = 0.011) higher for those who made more than USD 50,000 than those who made less. Survey results were compared to the Health Information National Trends Survey (HINTS) phase 4 cycle 3 data to evaluate national trends. Most of the subjects were able to correctly interpret the test cases, yet a majority did not share their results with a health-care professional. As the market for DTC genetic testing grows, test comprehension will become more critical. Involving more health professionals in this process may be necessary to ensure proper interpretations. © 2016 S. Karger AG, Basel.
Corpas, Manuel; Valdivia-Granda, Willy; Torres, Nazareth; Greshake, Bastian; Coletta, Alain; Knaus, Alexej; Harrison, Andrew P; Cariaso, Mike; Moran, Federico; Nielsen, Fiona; Swan, Daniel; Weiss Solís, David Y; Krawitz, Peter; Schacherer, Frank; Schols, Peter; Yang, Huangming; Borry, Pascal; Glusman, Gustavo; Robinson, Peter N
We describe the pioneering experience of a Spanish family pursuing the goal of understanding their own personal genetic data to the fullest possible extent using Direct to Consumer (DTC) tests. With full informed consent from the Corpas family, all genotype, exome and metagenome data from members of this family, are publicly available under a public domain Creative Commons 0 (CC0) license waiver. All scientists or companies analysing these data ("the Corpasome") were invited to return results to the family. We released 5 genotypes, 4 exomes, 1 metagenome from the Corpas family via a blog and figshare under a public domain license, inviting scientists to join the crowdsourcing efforts to analyse the genomes in return for coauthorship or acknowldgement in derived papers. Resulting analysis data were compiled via social media and direct email. Here we present the results of our investigations, combining the crowdsourced contributions and our own efforts. Four companies offering annotations for genomic variants were applied to four family exomes: BIOBASE, Ingenuity, Diploid, and GeneTalk. Starting from a common VCF file and after selecting for significant results from company reports, we find no overlap among described annotations. We additionally report on a gut microbiome analysis of a member of the Corpas family. This study presents an analysis of a diverse set of tools and methods offered by four DTC companies. The striking discordance of the results mirrors previous findings with respect to DTC analysis of SNP chip data, and highlights the difficulties of using DTC data for preventive medical care. To our knowledge, the data and analysis results from our crowdsourced study represent the most comprehensive exome and analysis for a family quartet using solely DTC data generation to date.
Lu, Mengfei; Lewis, Cathryn M; Traylor, Matthew
Rapid advances in scientific research have led to an increase in public awareness of genetic testing and pharmacogenetics. Direct-to-consumer (DTC) genetic testing companies, such as 23andMe, allow consumers to access their genetic information directly through an online service without the involvement of healthcare professionals. Here, we evaluate the clinical relevance of pharmacogenetic tests reported by 23andMe in their UK tests. The research papers listed under each 23andMe report were evaluated, extracting information on effect size, sample size and ethnicity. A wider literature search was performed to provide a fuller assessment of the pharmacogenetic test and variants were matched to FDA recommendations. Additional evidence from CPIC guidelines, PharmGKB, and Dutch Pharmacogenetics Working Group was reviewed to determine current clinical practice. The value of the tests across ethnic groups was determined, including information on linkage disequilibrium between the tested SNP and causal pharmacogenetic variant, where relevant. 23andMe offers 12 pharmacogenetic tests to their UK customers, some of which are in standard clinical practice, and others which are less widely applied. The clinical validity and clinical utility varies extensively between tests. The variants tested are likely to have different degrees of sensitivity due to different risk allele frequencies and linkage disequilibrium patterns across populations. The clinical relevance depends on the ethnicity of the individual and variability of pharmacogenetic markers. Further research is required to determine causal variants and provide more complete assessment of drug response and side effects. 23andMe reports provide some useful pharmacogenetics information, mirroring clinical tests that are in standard use. Other tests are unspecific, providing limited guidance and may not be useful for patients without professional interpretation. Nevertheless, DTC companies like 23andMe act as a powerful
Webborn, Nick; Williams, Alun; McNamee, Mike; Bouchard, Claude; Pitsiladis, Yannis; Ahmetov, Ildus; Ashley, Euan; Byrne, Nuala; Camporesi, Silvia; Collins, Malcolm; Dijkstra, Paul; Eynon, Nir; Fuku, Noriyuki; Garton, Fleur C; Hoppe, Nils; Holm, Søren; Kaye, Jane; Klissouras, Vassilis; Lucia, Alejandro; Maase, Kamiel; Moran, Colin; North, Kathryn N; Pigozzi, Fabio; Wang, Guan
The general consensus among sport and exercise genetics researchers is that genetic tests have no role to play in talent identification or the individualised prescription of training to maximise performance. Despite the lack of evidence, recent years have witnessed the rise of an emerging market of direct-to-consumer marketing (DTC) tests that claim to be able to identify children's athletic talents. Targeted consumers include mainly coaches and parents. There is concern among the scientific community that the current level of knowledge is being misrepresented for commercial purposes. There remains a lack of universally accepted guidelines and legislation for DTC testing in relation to all forms of genetic testing and not just for talent identification. There is concern over the lack of clarity of information over which specific genes or variants are being tested and the almost universal lack of appropriate genetic counselling for the interpretation of the genetic data to consumers. Furthermore independent studies have identified issues relating to quality control by DTC laboratories with different results being reported from samples from the same individual. Consequently, in the current state of knowledge, no child or young athlete should be exposed to DTC genetic testing to define or alter training or for talent identification aimed at selecting gifted children or adolescents. Large scale collaborative projects, may help to develop a stronger scientific foundation on these issues in the future. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
The considerable advances of genome sequencing over the past decades have had a profound impact on our daily life and opened up new avenues for the public to have access to their genetic information and learn more about their ancestry, genealogy and other traits that make each of us unique individuals. A very large number of individual single nucleotide polymorphisms (SNPs) have been associated to diseases whereas others have no known phenotype. For example, among the SNPs mapped within ccn1(cyr61), ccn2(ctgf), ccn3(nov), ccn4(wisp-1), ccn5(wisp-2) and ccn6 (wisp-3), only mutations within ccn4 were associated to PPD (the autosomal recessive skeletal disorder Progressive Pseudorheumatoid Dysplasia). On the occasion of this JCCS special issue on the roles of hormetic responses in adaptation, and response of living species to the modifications of their environment, it appeared that it was a good time to briefly review a topic that has been the subject of passionate discussions for the past few years, that is Direct to Consumer genetic tests (DTC GT). Based on the use of DNA analysis and identification of polymorphisms, DTC GT have been developed by several companies in the USA and in countries where there was no legal obstacle for customers to have direct access to their genetic information and manage their healthcare. Problems that arose and decisions that have been taken by regulatory agencies are presented and discussed in this editorial. The « freeze » of health-oriented DTC GT in the USA neither implies the end of DNA analysis nor « fun » applications, which are not aimed at providing risks estimates for particular illnesses. As shown in the example which is discussed in this editorial, DTC GT for cosmetic applications might be considered a fun application of great interest for companies such as L'Oréal, who recently developed the Makeup Genius mobile application. Other fun applications of DTC GT are discussed but there is no doubt that nothing will stop
Nielsen, Daiva Elena; Carere, Deanna Alexis; Wang, Catharine; Roberts, J Scott; Green, Robert C
The impacts of direct-to-consumer personal genomic testing (PGT) on health behaviors such as diet and exercise are poorly understood. Our investigation aimed to evaluate diet and exercise changes following PGT and to determine if changes were associated with genetic test results obtained from PGT. Customers of 23andMe and Pathway Genomics completed a web-based survey prior to receiving PGT results (baseline) and 6 months post-results. Fruit and vegetable intake (servings/day), and light, vigorous and strength exercise frequency (days/week) were assessed. Changes in diet and exercise were examined using paired t-tests and linear regressions. Additional analyses examined whether outcomes differed by baseline self-reported health (SRH) or content of PGT results. Longitudinal data were available for 1,002 participants. Significant increases were observed for vegetable intake (mean Δ = 0.11 (95% CI = 0.05, 0.17), p = 0.0003) and strength exercise (Δ = 0.14 (0.03, 0.25), p = 0.0153). When stratified by SRH, significant increases were observed for all outcomes among lower SRH participants: fruit intake, Δ = 0.11 (0.02, 0.21), p = 0.0148; vegetable intake, Δ = 0.16 (0.07, 0.25), p = 0.0005; light exercise, Δ = 0.25 (0.03, 0.47), p = 0.0263; vigorous exercise, Δ = 0.23 (0.06, 0.41), p = 0.0097; strength exercise, Δ = 0.19 (0.01, 0.37), p = 0.0369. A significant change among higher SRH participants was only observed for light exercise, and in the opposite direction: Δ = -0.2468 (-0.06, -0.44), p = 0.0111. Genetic results were not consistently associated with any diet or exercise changes. The experience of PGT was associated with modest, mostly positive changes in diet and exercise. Associations were independent of genetic results from PGT.
Palmer, Jessica Elizabeth
Should consumers be able to obtain information about their own bodies, even if it has no proven medical value? Direct-to-consumer ("DTC") genomic companies offer consumers two services: generation of the consumer's personal genetic sequence, and interpretation of that sequence in light of current research. Concerned that consumers will misunderstand genomic information and make ill-advised health decisions, regulators, legislators and scholars have advocated restricted access to DTC genomic services. The Food and Drug Administration, which has historically refrained from regulating most genetic tests, has announced its intent to treat DTC genomic services as medical devices because they make "medical claims." This Article argues that FDA regulation of genomic services as medical devices would be counterproductive. Clinical laboratories conducting genetic tests are already overseen by a federal regime administered by the Centers for Medicare and Medicaid Services. While consumers and clinicians would benefit from clearer communication of test results and their health implications, FDA's gatekeeping framework is ill-suited to weigh the safety and efficacy of genomic information that is not medically actionable in traditional ways. Playing gatekeeper would burden FDA's resources, conflict with the patient-empowering policies promoted by personalized medicine initiatives, impair individuals' access to information in which they have powerful autonomy interests, weaken novel participatory research infrastructures, and set a poor precedent for the future regulation of medical information. Rather than applying its risk-based regulatory framework to genetic information, FDA should ameliorate regulatory uncertainty by working with the Federal Trade Commission and Centers for Medicare and Medicaid Services to ensure that DTC genomic services deliver analytically valid data, market and implement their services in a truthful manner, and fully disclose the limitations of their
Fears, R.; Boccia, S.; Cornel, M.C.; Delpech, M.; Estivill, X.; Hansson, M.; Karalis, K.; Metspalu, A.; Nothen, M.; Propping, P.; Sequeiros, J.; Zimmem, R.; ter Meulen, V.
Direct-to-consumer (DTC) genetic testing services raise scientific, regulatory and ethical questions. A report was prepared by consultation with an expert Working Group and published by the academies of science (European Academies of Science Advisory Council, EASAC) and medicine (Federation of
Soneji, Samir; Ambrose, Bridget K; Lee, Won; Sargent, James; Tanski, Susanne
We assess exposure to direct-to-consumer tobacco marketing and its association with ever having tried smoking, smoking within past 30 days (current), and smoking ≥100 cigarettes in lifetime (established) among adolescents and young adults. We surveyed a U.S. telephone sample of 3,342 15- to 23-year-olds and 2,541 respondents subsequently completed a web-based survey. Among respondents completing both the telephone and web-based surveys (N = 2,541 [75%]), we assessed their exposure to direct-to-consumer tobacco marketing (receiving direct mail from tobacco companies and seeing tobacco company websites) and their associations with ever having tried smoking, current smoking, and established smoking. Overall, 12% of 15- to 17-year-olds and 26% of 18- to 23-year-olds were exposed to direct-to-consumer tobacco marketing. Racial/ethnic minority nonsmoking respondents were more likely to see tobacco websites than nonsmoking whites. Respondents exposed to either form of direct-to-consumer tobacco marketing were more likely to currently smoke (adjusted odds ratio 2.2, 95% confidence interval 1.3-3.8), while those exposed to both forms of marketing experienced even higher odds of currently smoking (adjusted odds ratio 2.7, 95% confidence interval 1.1-6.6). We observed similar relationships for ever having tried smoking and established smoking. Direct-to-consumer tobacco marketing reaches adolescent and young adult nonsmokers and is associated with smoking behavior. Copyright © 2014 Society for Adolescent Health and Medicine. All rights reserved.
Soneji, Samir; Ambrose, Bridget K.; Lee, Won; Sargent, James; Tanski, Susanne
Objective We assess exposure to direct-to-consumer tobacco marketing and its association with ever having tried smoking, smoking within past 30 days (‘current’), and smoking ≥100 cigarettes in lifetime (‘established’) among adolescents and young adults. Methods We surveyed a U.S. telephone sample of 3,342 15–23 year olds and 2,541 respondents subsequently completed a web-based survey. Among respondents completing both the telephone and web-based surveys (N=2,541 [75%]), we assessed their exposure to direct-to-consumer tobacco marketing (receiving direct mail from tobacco companies and seeing tobacco company websites) and their associations with ever having tried smoking, current smoking, and established smoking. Results Overall, 12% of 15–17 year olds and 26% of 18–23 year olds were exposed to direct-to-consumer tobacco marketing. Racial/ethnic minority non-smoking respondents were more likely to see tobacco websites than non-smoking Whites. Respondents exposed to either form of direct-to-consumer tobacco marketing were more likely to currently smoke (adjusted odds ratio[AOR]: 2.2; 95% CI 1.3–3.8), while those exposed to both forms of marketing experienced even higher odds of currently smoking (AOR: 2.7; 95% CI 1.1–6.6). We observed similar relationships for ever having tried smoking and established smoking. Conclusions Direct-to-consumer tobacco marketing reaches adolescent and young adult non-smokers and is associated with smoking behavior. PMID:24661738
Aikin, Kathryn J; Sullivan, Helen W; Dolina, Suzanne; Lynch, Molly; Squiers, Linda B
US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages
Semin, Semih; Aras, Şahbal; Guldal, Dilek
While several major problems concerning drugs occur in the world, the attempts to direct‐to‐consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives’ work efficiency; drug reimbursement restrictions; and t...
Borry, Pascal; Howard, Heidi C; Sénécal, Karine; Avard, Denise
More and more companies are advertising and selling genetic tests directly to consumers. Considering the ethical, legal, and psychological concerns surrounding genetic testing in minors, a study of companies' websites was performed in order to describe and analyze their policies with respect to this issue. Of the 29 companies analyzed, 13 did not provide any information about this matter, eight companies allowed genetic testing upon parental request, four companies stated that their website is not directed to children under 18 years, and four companies suggested that in order to be tested, applicants should have reached the age of legal majority. If private companies offer genetic tests which are also offered in a clinical setting, can they be expected to adhere to the existing clinical guidelines with regard to these tests? If so, a certain ambiguity exists. Many companies are emphasizing in their disclaimers that their services are not medical services and should not be used as a basis for making medical decisions. Nonetheless, it remains debatable whether genetic testing in minors would be appropriate in this context. In line with the Advisory Committee on Genetic Testing, the Human Genetics Commission addressed the problem of non-consensual testing and recommended not to supply genetic testing services directly to those under the age of 16 or to those not able to make a competent decision regarding testing.
Salloum, Ramzi G; George, Thomas J; Silver, Natalie; Markham, Merry-Jennifer; Hall, Jaclyn M; Guo, Yi; Bian, Jiang; Shenkman, Elizabeth A
Access to direct-to-consumer genetic testing services has increased in recent years. However, disparities in knowledge and awareness of these services are not well documented. We examined awareness of genetic testing services by rural/urban and racial/ethnic status. Analyses were conducted using pooled cross-sectional data from 4 waves (2011-2014) of the Health Information National Trends Survey (HINTS). Descriptive statistics compared sample characteristics and information sources by rural/urban residence. Logistic regression was used to examine the relationship between geography, racial/ethnic status, and awareness of genetic testing, controlling for sociodemographic characteristics. Of 13,749 respondents, 16.7% resided in rural areas, 13.8% were Hispanic, and 10.1% were non-Hispanic black. Rural residents were less likely than urban residents to report awareness of genetic testing (OR = 0.74, 95% CI = 0.63-0.87). Compared with non-Hispanic whites, racial/ethnic minorities were less likely to be aware of genetic testing: Hispanic (OR = 0.68, 95% CI = 0.56-0.82); and non-Hispanic black (OR = 0.74, 95% CI = 0.61-0.90). Rural-urban and racial-ethnic differences exist in awareness of direct-to-consumer genetic testing. These differences may translate into disparities in the uptake of genetic testing, health behavior change, and disease prevention through precision and personalized medicine.
Chokoshvili, Davit; Vears, Danya F; Borry, Pascal
Since the introduction of out-of-hospital health-related genetic tests more than a decade ago, the landscape of genetic testing services has grown in complexity. Although initially most genetic tests for health purposes were offered as direct-to-consumer services, that is, without the mediation of a medical professional, currently many commercial providers require that their tests be ordered by a licensed physician. At the same time, some commercially developed health-related genetic tests are gaining support from the professional medical community and are finding their way into clinical practice. Therefore, we differentiated between three types of genetic testing offers: direct-to-consumer, physician-mediated, and clinic-based genetic testing. Expanded carrier screening tests for recessive disorders are currently available through all the three models of genetic testing. Herein, we review the present landscape of expanded carrier screening offers by highlighting the distinct issues associated with each of the three types of genetic testing. Copyright © 2017. Published by Elsevier Ltd.
Singleton, Amanda; Erby, Lori Hamby; Foisie, Kathryn V; Kaphingst, Kimberly A
An informed choice about health-related direct-to-consumer genetic testing (DTCGT) requires knowledge of potential benefits, risks, and limitations. To understand the information that potential consumers of DTCGT services are exposed to on company websites, we conducted a content analysis of 23 health-related DTCGT websites. Results revealed that benefit statements outweighed risk and limitation statements 6 to 1. The most frequently described benefits were: 1) disease prevention, 2) consumer education, 3) personalized medical recommendations, and 4) the ability to make health decisions. Thirty-five percent of websites also presented at least one risk of testing. Seventy-eight percent of websites mentioned at least one limitation of testing. Based on this information, potential consumers might get an inaccurate picture of genetic testing which could impact their ability to make an informed decision. Practices that enhance the presentation of balanced information on DTCGT company websites should be encouraged.
Lowery, Jan T; Byers, Tim; Axell, Lisen; Ku, Lisa; Jacobellis, Jillian
To assess the impact of direct-to-consumer marketing for genetic testing among women of varying genetic risk for breast and ovarian cancer. Telephone surveys were conducted with 315 women in Denver, Colorado, one target audience for the Myriad BRACAnalysis ad campaign. Genetic risk was determined from personal and family history and grouped by probability of having a BRCA1/2 mutation (low or =10%). High-risk women were more knowledgeable about BRACAnalysis and more likely to recall the media ads than were low-risk women (60 vs. 39%, P audience. Concern about breast cancer was not appreciably increased. A large percentage of low-risk women (not candidates for testing) expressed interest in testing, suggesting the campaign was too broad. A campaign targeted at high-risk women, who may benefit from testing might be preferred.
Messner, Donna A
Health-related direct-to-consumer (DTC) genetic testing has been a controversial practice. Especially problematic is predictive testing for Alzheimer disease (AD), since the disease is incurable, prevention is inconclusive, and testing does not definitively predict an individual's future disease status. In this paper, I examine two contrasting cases of subjects who learn through genetic testing that they have an elevated risk of developing AD later in life. In these cases, the subject's emotional response to the result is related to how well prepared she was for the real-life personal implications of possible test results. Analysis leads to the conclusion that when groups of health-related genetic tests are offered as packages by DTC companies, informed consumer choice is rendered impossible. Moreover, I argue, this marketing approach contravenes U.S. Federal Trade Commission policies for non-deceptive commercial communications. I conclude by suggesting ways to improve the prospects for informed consumer choice in DTC testing.
Khatamian, Yasha Borna; Fahoum, Firas; Gotman, Jean
Two-dimensional temporal clustering analysis (2D-TCA) is a relatively new functional MRI (fMRI) based technique that breaks blood oxygen level dependent activity into separate components based on timing and has shown potential for localizing epileptic activity independently of electroencephalography (EEG). 2D-TCA has only been applied to detect epileptic activity in a few studies and its limits in detecting activity of various forms (i.e. activation size, amplitude, and frequency) have not been investigated. This study evaluated 2D-TCA's ability to detect various forms of both simulated epileptic activity and EEG-fMRI activity detected in patients. When applied to simulated data, 2D-TCA consistently detected activity in 6min runs containing 5 spikes/run, 10 spikes/run, and one 5s long event with hemodynamic response function amplitudes of at least 1.5%, 1.25%, and 1% above baseline respectively. When applied to patient data, while detection of interictal spikes was inconsistent, 2D-TCA consistently produced results similar to those obtained by EEG-fMRI when at least 2 prolonged interictal events (a few seconds each) occurred during the run. However, even for such cases it was determined that 2D-TCA can only be used to validate localization by other means or to create hypotheses as to where activity may occur, as it also detects changes not caused by epileptic activity. Copyright © 2011 Elsevier B.V. All rights reserved.
Egglestone, Corin; Morris, Anne; O'Brien, Ann
Direct-to-consumer (DTC) genetic tests can be purchased over the internet. Some companies claim to provide relative genetic risks for various diseases and thus encourage healthy behaviour. There are concerns that exposure to such information may actually discourage healthy behaviour or increase health anxiety. An online survey was conducted (n = 275). Respondents were composed of individuals who had purchased a DTC genetic test and received their results (consumers, n = 189), as well as individuals who were either awaiting test results or considering purchasing a test (potential consumers, n = 86). Consumers were asked if their health behaviour or health anxiety had changed after receiving their results. Respondents' current health behaviour and health anxiety were queried and compared. In total, 27.3 % of consumers claimed a change in health behaviour, all either positive or neutral, with no reported cessation of any existing health behaviour. A change in health anxiety was claimed by 24.6 % of consumers, 85.3 % of which were a reduction. Consumers had significantly better health behaviour scores than potential consumers (p = 0.02), with no significant difference in health anxiety. This study points towards an association between receipt of DTC genetic test results and increased adoption of healthy behaviours for a minority of consumers based on self-report, with more mixed results in relation to health anxiety.
Mavroidopoulou, Vasiliki; Xera, Ellie; Mollaki, Vasiliki
Direct-to-consumer genetic testing (DTCGT) is now offered by numerous companies. The present survey aimed to explore awareness, interest, reasons to take and refuse DTCGT, and understanding of results amongst 725 higher education students in Greece. A third of the responders were aware of DTCGT and interest was dependent on cost. More than 60% of the participants would undergo DTCGT to learn more about their health, to warn their children, so that their doctor can monitor their health and change their lifestyle. Nevertheless, they would prefer to consult their doctor first and expressed concerned about their personal data. After receiving results from a hypothetical DTC genetic test predicting higher risk for colon cancer, 59.5% of the responders thought that they could understand the results but 46.1% believed that the results have diagnostic value. In total, 83.6% of the participants would ask their doctor to explain the results and 70.4% would discuss results with their family. In conclusion, the majority of higher education students in Greece appreciate the benefits of genetic testing but with the involvement of their doctor. A physician's participation in the process and informing the public about the true value of genetic testing, are crucial to avoid misinterpretation of DTCGT results.
Increasing numbers of donor-conceived individuals (and/or parents) are seeking individuals genetically related through donor conception. One route is through 'direct-to-consumer' (DTC) DNA testing, prompting calls for fertility services to alert donors and prospective parents to the increasing unsustainability of anonymity and secrecy. The complexity of interpreting DNA results in this context has also been discussed, including their lack of absolute certainty, as has the need for professional and peer support. This commentary highlights a different 'threat', from individuals learning of their donor-conception origins through the use of such tests by themselves or relatives for such purposes as genealogy or health checks. It illustrates the personal complexities faced by three older women and their families on learning not only of their genetic relationship to each other but also to 15 more donor-related siblings. DTC DNA services are a growing feature of modern life. This commentary raises ethical questions about their responsibilities towards those inadvertently learning of donor conception origins and the responsibilities of fertility services to inform prospective parents and donors of this new phenomenon. Considerations of how and when parents should tell their children of their donor-conception origins here instead become how and when children should inform their parents.
Wasson, Katherine; Cook, E David; Helzlsouer, Kathy
The development of genetic tests marketed and sold direct-to-consumers (DTC) via the internet raises moral concerns and debate about their appropriateness and ethical and clinical significance. These tests are offered for a wide range of diseases and conditions, and the mutations have variable penetrance and associated risk. A number of these tests lack data on their accuracy and reliability, making interpretation of results difficult. DTC genetic testing is undertaken outside the context of the physician-patient relationship and may lack appropriate individual and family genetic counseling, leaving the consumer vulnerable to potential harms, such as misinterpretation of results, including false positive or false reassurance, with limited or no benefits. Beauchamp and Childress's four principles of biomedical ethics provide a framework for analyzing the ethical issues raised by DTC genetic testing. We argue that the potential harms outweigh the potential benefits of such tests, that respect for autonomy should be limited in light of potential harm from DTC testing, and that the availability of genetic testing over the internet may be considered unfair and unjust and affect resource allocation by placing an unfair burden on primary care physicians. In light of the moral issues posed by these tests, practical responses are suggested in the areas of consumer education, medical education, and interaction with commercial companies.
Bansback, Nick; Sizto, Sonia; Guh, Daphne; Anis, Aslam H
Numerous websites offer direct-to-consumer (DTC) genetic testing, yet it is unknown how individuals will react to genetic risk profiles online. The objective of this study was to determine the feasibility of using a web-based survey and conjoint methods to elicit individuals' interpretations of genetic risk profiles by their anticipated worry/anxiousness and health-seeking behaviors. A web-based survey was developed using conjoint methods. Each survey presented 12 hypothetical genetic risk profiles describing genetic test results for four diseases. Test results were characterized by the type of disease (eight diseases), individual risk (five levels), and research confidence (three levels). After each profile, four questions were asked regarding anticipated worry and health-seeking behaviors. Probabilities of response outcomes based on attribute levels were estimated from logistic regression models, adjusting for covariates. Overall, 319 participants (69%) completed 3828 unique genetic risk profiles. Across all profiles, most participants anticipated making doctor's appointments (63%), lifestyle changes (57%), and accessing screening (57%); 40% anticipated feeling more worried and anxious. Higher levels of disease risk were significantly associated with affirmative responses. Conjoint methods may be used to elicit reactions to genetic information online. Preliminary results suggest that genetic information may increase worry/anxiousness and health-seeking behaviors among consumers of DTC tests. Further research is planned to determine the appropriateness of these affects and behaviors.
Rutten, L. J. F.; Gollust, S. E.; Naveed, S.; Moser, R. P.
Uncertainty around the value of and appropriate regulatory models for direct-to-consumer (DTC) genetic testing underscores the importance of tracking public awareness of these services. We analyzed nationally representative, cross-sectional data from the Health Information National Trends Survey in 2008 (n=7, 674) and 2011 (n=3, 959) to assess population-level changes in awareness of DTC genetic testing in the U.S. and to explore socio demographic, health care, Internet use, and population density correlates. Overall, awareness increased significantly from 29% in 2008 to 37% in 2011. The observed increase in awareness from 2008 to 2011 remained significant (OR=1.39) even when adjusted for socio demographic variables, health care access, Internet use, and population density. Independent of survey year, the odds of awareness of DTC genetic tests were significantly higher for those aged 50-64 (OR=1.64), and 65-74 (O R=1.60); college graduates (OR=2.02 ); those with a regular source of health care (OR=1.27); those with a prior cancer diagnosis (OR=1.24); those who use the Internet (OR=1.27); and those living in urban areas ( OR=1.25). Surveillance of awareness-along with empirical data on use of and response to genetic risk information-can inform public health and policy efforts to maximize benefits and minimize risks of DTC genetic testing.
Lila J. Finney Rutten
Full Text Available Uncertainty around the value of and appropriate regulatory models for direct-to-consumer (DTC genetic testing underscores the importance of tracking public awareness of these services. We analyzed nationally representative, cross-sectional data from the Health Information National Trends Survey in 2008 (n=7,674 and 2011 (n=3,959 to assess population-level changes in awareness of DTC genetic testing in the U.S. and to explore sociodemographic, health care, Internet use, and population density correlates. Overall, awareness increased significantly from 29% in 2008 to 37% in 2011. The observed increase in awareness from 2008 to 2011 remained significant (OR=1.39 even when adjusted for sociodemographic variables, health care access, Internet use, and population density. Independent of survey year, the odds of awareness of DTC genetic tests were significantly higher for those aged 50–64 (OR=1.64, and 65–74 (OR=1.60; college graduates (OR=2.02; those with a regular source of health care (OR=1.27; those with a prior cancer diagnosis (OR=1.24; those who use the Internet (OR=1.27; and those living in urban areas (OR=1.25. Surveillance of awareness—along with empirical data on use of and response to genetic risk information—can inform public health and policy efforts to maximize benefits and minimize risks of DTC genetic testing.
Finney Rutten, Lila J; Gollust, Sarah E; Naveed, Sana; Moser, Richard P
Uncertainty around the value of and appropriate regulatory models for direct-to-consumer (DTC) genetic testing underscores the importance of tracking public awareness of these services. We analyzed nationally representative, cross-sectional data from the Health Information National Trends Survey in 2008 (n = 7, 674) and 2011 (n = 3, 959) to assess population-level changes in awareness of DTC genetic testing in the U.S. and to explore sociodemographic, health care, Internet use, and population density correlates. Overall, awareness increased significantly from 29% in 2008 to 37% in 2011. The observed increase in awareness from 2008 to 2011 remained significant (OR = 1.39) even when adjusted for sociodemographic variables, health care access, Internet use, and population density. Independent of survey year, the odds of awareness of DTC genetic tests were significantly higher for those aged 50-64 (OR = 1.64), and 65-74 (OR = 1.60); college graduates (OR = 2.02); those with a regular source of health care (OR = 1.27); those with a prior cancer diagnosis (OR = 1.24); those who use the Internet (OR = 1.27); and those living in urban areas (OR = 1.25). Surveillance of awareness-along with empirical data on use of and response to genetic risk information-can inform public health and policy efforts to maximize benefits and minimize risks of DTC genetic testing.
Wasson, Katherine; Cherny, Sara; Sanders, Tonya Nashay; Hogan, Nancy S; Helzlsouer, Kathy J
Direct-to-consumer genetic testing (DTCGT) offers risk estimates for a variety of complex diseases and conditions, yet little is known about its impact on actual users, including their decisions about sharing the information gleaned from testing. Ethical considerations include the impact of unsolicited genetic information with variable validity and clinical utility on relatives, and the possible burden to the health care system if revealed to physicians. The qualitative study explored primary care patients' views, attitudes, and decision making considerations regarding DTCGT. This article focuses on the disclosure decisions participants made regarding participation, testing, and results of DTCGT, a topic which arose as a secondary aim of the study. Through four longitudinal interviews (pre-test, results, 3 and 12 months post-test) we examined twenty primary care patients' decisions, expressed intentions, and actions regarding disclosure to immediate and extended family, friends and coworkers, and physicians about participation in and results of DTCGT. Individual interviews were analyzed using qualitative content analysis and a summative approach to describe the global themes. Most participants disclosed to some immediate family; less than half disclosed to extended family; approximately half talked to friends. Most participants stated they would or might disclose to physicians about DTCGT and a few did. Conceptual themes that emerged from the data analysis include ambivalence about disclosure, consistency between intention and actual disclosure behavior and decisions, and conditional information sharing. Participants' intentional and actual disclosure patterns offer insight into how they view DTCGT, weigh results, and the potential impact of DTCGT.
Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N
Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.
Boeldt, D L; Schork, N J; Topol, E J; Bloss, C S
Individuals who undergo multiplex direct-to-consumer (DTC) genomic testing receive genetic risk results for multiple conditions. To date, research has not investigated the influence of individual differences in disease perceptions among consumers on testing outcomes. A total of 2037 participants received DTC genomic testing and completed baseline and follow-up surveys assessing disease perceptions and health behaviors. Participants were asked to indicate their most feared disease of those tested. Perceived seriousness and controllability of the disease via lifestyle or medical intervention were assessed. Participants most frequently reported heart attack (19.1%) and Alzheimer's disease (18.6%) as their most feared disease. Perceived seriousness and control over the feared disease both influenced response to DTC genomic testing. Greater perceived seriousness and diminished perceived control were associated with higher, but not clinically significant levels of anxiety and distress. In some cases these associations were modified by genetic risk. No significant associations were observed for diet, exercise and screening behaviors. Individual differences in disease perceptions influence psychological outcomes following DTC genomic testing. Higher perceived seriousness may make a consumer more psychologically sensitive to test results and greater perceived control may protect against adverse psychological outcomes. Findings may inform development of educational and counseling services. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Francesca Renee Dillman Carpentier
Full Text Available This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media.
Carpentier, Francesca Renee Dillman
This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim's article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim's rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA's attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media. © 2016 by Kerman University of Medical Sciences.
Like all interventions in health care, direct-to-consumer (DTC) advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-undemonstrated benefits of the advertising.
Su, Yeyang; Borry, Pascal; Otte, Ina C; Howard, Heidi C
Various companies are currently advertising or selling genetic tests over the internet using a model of provision referred to as 'direct-to-consumer' (DTC). This commercial offer of DTC genetic testing (GT) has fueled a number of scientific, ethical and policy debates. To date there have been few studies published regarding the users' perspective. This study aimed to obtain information regarding the issues raised by individuals who signed a petition in support of DTC GT and the 'unrestricted' access to their genetic information. We conducted qualitative content analysis of comments written by individuals who signed a public online petition initiated by DIYgenomics (CA, USA) to support "personal access to genetic information". Of the 523 individuals who signed the petition sponsored by DIYgenomics, 247 individuals also wrote individual comments. A content analysis of these comments reveals that petitioners raised six main issues in support of unrestricted access to DTC GT: that their ownership of their DNA should allow them to have unrestricted access to their genomic information; that they should have the right to their genomic information; that the government has no place in (further) regulating DTC GT; that healthcare professionals should not be placed as intermediaries when purchasing DTC GT services; that many petioners who had already obtained DTC GT had positive experiences with this model of provision; and that genealogy or ancestry DNA testing is one of the main activities petitioners wish to have 'unrestricted' or 'direct' access. These results give insight into why individuals may support unrestricted access to their genomic information and confirm some of the motivations of users for purchasing DTC GT. Our analysis also brings to the forefront themes that have been raised less often in empirical studies involving motivations to purchase DTC GT services; these include the strongly held beliefs of some petitioners that, since they own their DNA, they
Breast and ovarian cancer are the second and fifth leading causes of cancer death, respectively, among women in the United States. One in eight women will have breast cancer during their lifetimes, and one in 70 will have ovarian cancer. Mutations in two genes, BRCA1 and BRCA2 (BRCA1/2), are associated with predisposition for inherited breast and ovarian cancer and are identified in 5%-10% of women with breast or ovarian cancer (BOC). Since 1996, genetic testing for these mutations has been available clinically; however, population-based screening is not recommended because of the complexity of test interpretation and limited data on clinical validity and utility. Despite the test's limited applicability in the general population, the U.S. provider of clinical BRCA1/2 testing (Myriad Genetic Laboratories, Inc., Salt Lake City, Utah) conducted a pilot direct-to-consumer (DTC) marketing campaign in two cities (Atlanta, Georgia, and Denver, Colorado) during September 2002-February 2003. Although DTC advertisements have been used to raise consumer awareness about pharmaceuticals, this was the first time an established genetic test was marketed to the public. To assess the impact of the campaign on consumer behaviors and health-care provider practices, CDC and the respective state health departments for the pilot cities and two comparison cities (Raleigh-Durham, North Carolina, and Seattle, Washington) surveyed consumers and providers. This report summarizes results of those surveys, which indicated that consumer and provider awareness of BRCA1/2 testing increased in the pilot cities and that providers in these cities perceived an impact on their practice (e.g., more questions asked about testing, more BRCA1/2 tests requested, and more tests ordered). However, in all four cities, providers often lacked knowledge to advise patients about inherited BOC and testing. These findings underscore the need for evidence-based recommendations on appropriate use of genetic tests
Horner, Claire; Tenenbaum, Evelyn; Sipp, Douglas; Master, Zubin
The sale of unproven stem cell interventions (SCIs) by commercial entities has proliferated in highly developed countries, most notably in the USA. Yet, there have been few criminal prosecutions and regulatory enforcement actions against providers who have violated laws and best practice standards due to the lack of resources and legal ambiguity. While the stem cell research community has invested much in protecting patients and preventing the growth of this industry, some patients are seeking remedies under civil law to hold stem cell clinics responsible for fraudulent practices. Several patients have filed lawsuits against providers demanding compensation for physical injuries caused by unproven treatments and financial losses due to fraud and false advertising. Lawsuits can be used as a tool not only to compensate plaintiffs but also to achieve positive public health and policy outcomes. In this paper, we explore the value of a public health litigation strategy as a countermeasure against the exploitative practices of the unproven SCI industry by analyzing stem cell lawsuits and comparing them with other major public health litigation efforts. We argue that stem cell lawsuits complement other approaches to reining in unsafe practices. In particular, stem cell lawsuits could intensify publicity and raise awareness of the harms of unproven treatments, set legal precedent, reshape the media narrative from one focused on the right to try or practice to one highlighting the need for adequate safety and efficacy standards, and encourage authorities to turn their attention to policy reform and enforcement.
Hyosun Kim’s report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it PMID:27239884
Hall, Danika; Jones, Sandra; Iverson, Don
In Australia, where direct to consumer advertising of prescription medicines is prohibited, pharmaceutical companies can sponsor disease awareness advertising targeting consumers. This study examined the impact of disease awareness advertising exposure on older women's reported behavioural intentions. Women were approached in a shopping centre and randomly assigned mock advertisements for two health conditions. Disease information and sponsors were manipulated. Two hundred and forty-one women responded to 466 advertisements. Almost half reported an intention to ask their doctor for a prescription or referral as a result of seeing the advertisement, but more reported they would talk to their doctor and ask about treatments and tests. Participants were more likely to report an intention to ask for prescriptions if they perceived the health condition to be severe and themselves susceptible or if they had viewed advertisements containing limited information on the disease. Disease awareness advertising may stimulate demand for prescription medicine products. This has serious implications for general practitioners and regulators.
Kamenica, Emir; Naclerio, Robert; Malani, Anup
We conducted randomized clinical trials to examine the impact of direct-to-consumer advertisements on the efficacy of a branded drug. We compared the objectively measured, physiological effect of Claritin (Merck & Co.), a leading antihistamine medication, across subjects randomized to watch a movie spliced with advertisements for Claritin or advertisements for Zyrtec (McNeil), a competitor antihistamine. Among subjects who test negative for common allergies, exposure to Claritin advertisements rather than Zyrtec advertisements increases the efficacy of Claritin. We conclude that branded drugs can interact with exposure to television advertisements. PMID:23878212
In this paper, I investigate ethical and policy aspects of the genetic services and web-rhetoric of companies offering genetic information direct to consumer, and I do so with a special focus on genetic risk information. On their websites, the companies stress that genetic risk testing for multifactorial complex medical conditions such as cardiovascular disease and cancer may empower the consumer and provide valuable input to personal identity. Critics maintain, on the other hand, that testing can be psychologically harmful, is of limited clinical and preventive value, and vulnerable to misinterpretation. I stress the importance of empirical studies in assessing the pros and cons of direct-to-consumer testing and point out that recent empirical studies indicate that this testing is neither as harmful as feared by critics nor as empowering as promised by the companies. However, the testing is not entirely harmless. Remaining problems include testing of third parties without consent and ownership of genotypic and phenotypic information. Moreover, the testing, although not particularly empowering, may still provide input to self-understanding that some people find valuable. Regarding policy-making, I suggest that self-regulation in terms of best practice guidelines may play an important role, but I also stress that national and international regulation may be necessary.
Becker, Sara J
The overall chasm between those who need treatment for mental health and substance abuse (M/SU) and those who receive effective treatment consists of two, interrelated gaps: the research-to-practice gap and the treatment gap. Prior efforts to disseminate evidence-based practice (EBP) for M/SU have predominantly targeted the research-to-practice gap, by focusing efforts toward treatment providers. This article introduces direct-to-consumer (DTC) marketing that targets patients and caregivers as a complementary approach to existing dissemination efforts. Specific issues discussed include: rationale for DTC marketing based on the concept of push versus pull marketing; overview of key stakeholders involved in DTC marketing; and description of the Marketing Mix planning framework. The applicability of these issues to the dissemination of EBP for M/SU is discussed.
Becker, Sara J.
The overall chasm between those who need treatment for mental health and substance abuse (M/SU) and those who receive effective treatment consists of two, interrelated gaps: the research-to-practice gap and the treatment gap. Prior efforts to disseminate evidence-based practice (EBP) for M/SU have predominantly targeted the research-to-practice gap, by focusing efforts toward treatment providers. This article introduces direct-to-consumer (DTC) marketing that targets patients and caregivers as a complementary approach to existing dissemination efforts. Specific issues discussed include: rationale for DTC marketing based on the concept of push versus pull marketing; overview of key stakeholders involved in DTC marketing; and description of the Marketing Mix planning framework. The applicability of these issues to the dissemination of EBP for M/SU is discussed. PMID:25937710
Stewart, Kelly F J; Wesselius, Anke; Schreurs, Maartje A C; Schols, Annemie M W J; Zeegers, Maurice P
It has been hypothesised that direct-to-consumer genetic tests (DTC-GTs) could stimulate health behaviour change. However, genetic testing may also lead to anxiety and distress or unnecessarily burden the health care system. The aim is to review and meta-analyse the effects of DTC-GT on (1) behaviour change, (2) psychological response and (3) medical consumption. A systematic literature search was performed in three databases, using "direct-to-consumer genetic testing" as a key search term. Random effects meta-analyses were performed when at least two comparable outcomes were available. After selection, 19 articles were included involving 11 unique studies. Seven studies involved actual consumers who paid the retail price, whereas four included participants who received free genetic testing as part of a research trial (non-actual consumers). In meta-analysis, 23% had a positive lifestyle change. More specifically, improved dietary and exercise practices were both reported by 12%, whereas 19% quit smoking. Seven percent of participants had subsequent preventive checks. Thirty-three percent shared their results with any health care professional and 50% with family and/or friends. Sub-analyses show that behaviour change was more prevalent among non-actual consumers, whereas sharing was more prevalent among actual consumers. Results on psychological responses showed that anxiety, distress and worry were low or absent and that the effect faded with time. DTC-GT has potential to be effective as a health intervention, but the right audience needs to be addressed with tailored follow-up. Research is needed to identify consumers who do and do not change behaviour or experience adverse psychological responses.
Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better? Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".
Hyosun Kim's report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it. © 2016 by Kerman University of Medical Sciences.
Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better?; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Full Text Available Hyosun Kim’s report “Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters”aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it.
Howard, Heidi Carmen; Avard, Denise; Borry, Pascal
The genetic testing of minors within the direct-to-consumer (DTC) genetic testing (GT) context has been given relatively little attention. The issue of testing healthy children for diseases that would only develop in adulthood raises many important ethical, legal and social issues. As genetic testing is now available outside of the traditional health care system, often without even the intermediate of a health care professional, we surveyed 37 DTC GT companies regarding their policies for testing in children. Although the response rate is relatively low (35%, 13/37), our findings reveal that a clear majority of companies do perform genetic testing in minors. As such, companies testing for adult onset diseases are acting in contradiction of established professional guidelines, which state, among others, that, for predictive genetic testing, the availability of therapeutic or preventive measures is necessary for testing to be performed in asymptomatic minors. The community of stakeholders in children's health care and genetic testing should, therefore, decide which standards need to be upheld by DTC GT companies and ensure that these are met. PMID:21629297
Myers, Melanie F; Chang, Man-Huei; Jorgensen, Cynthia; Whitworth, William; Kassim, Sidibe; Litch, James A; Armstrong, Lori; Bernhardt, Barbara; Faucett, W Andrew; Irwin, Debra; Mouchawar, Judy; Bradley, Linda A
To assess the impact of direct-to-consumer marketing of genetic testing for risk of breast and ovarian cancer by a biotechnology company on: 1) physicians' knowledge; 2) reasons given when asking questions about the test; and 3) physicians' practice patterns in two pilot cities where the campaign took place and two control cities. Survey of randomly selected family physicians, internists, obstetrician-gynecologists, and oncologists from May 1-May 21, 2003. Physicians' knowledge did not differ between pilot and control cities. Significant differences (pilot versus control cities) were seen in the reasons patients gave for asking questions about testing. More physicians in pilot cities (14%) than control cities (7%) reported an increase in the number of times they ordered genetic testing for breast and ovarian cancer risk in the previous 6 months (adjusted odds ratio 1.9, 95% confidence interval, 1.2-3.1). Awareness of professional guidelines and being in a practice with a policy on genetic testing for risk of breast and ovarian cancer were associated with physicians' behaviors and interest among patients in testing. Given the complexity and limitations of genetic testing for risk of breast and ovarian cancer, the development and broad dissemination of clinical guidelines and education of physicians are needed.
Howard, Heidi Carmen; Avard, Denise; Borry, Pascal
The genetic testing of minors within the direct-to-consumer (DTC) genetic testing (GT) context has been given relatively little attention. The issue of testing healthy children for diseases that would only develop in adulthood raises many important ethical, legal and social issues. As genetic testing is now available outside of the traditional health care system, often without even the intermediate of a health care professional, we surveyed 37 DTC GT companies regarding their policies for testing in children. Although the response rate is relatively low (35%, 13/37), our findings reveal that a clear majority of companies do perform genetic testing in minors. As such, companies testing for adult onset diseases are acting in contradiction of established professional guidelines, which state, among others, that, for predictive genetic testing, the availability of therapeutic or preventive measures is necessary for testing to be performed in asymptomatic minors. The community of stakeholders in children's health care and genetic testing should, therefore, decide which standards need to be upheld by DTC GT companies and ensure that these are met.
van Hellemondt, Rachèl; Hendriks, Aart; Breuning, Martijn
The legal framework of the European Union (EU) for regulating access to and supply of direct-to-consumer (DTC) genetic tests is very liberal compared to the legal and regulatory framework for (internet) medicines. Nevertheless, both health related products can cause equally serious damage to the well being of individuals. In this contribution we examine whether the legal framework of the EU for the safety and responsible use of (internet) medicines could be an example for regulating access to and supply of DTC genetic tests. The EU laws governing medicines can, notwithstanding their shortcomings, serve as an example for (central) authorising the marketing of DTC genetic tests on the internal market in accordance with strict criteria regarding predictive value and clinical usefulness. Furthermore, a legal framework controlling DTC genetic tests also should introduce system supervision as well as quality criteria with respect to the information to be provided to consumers in order to enhance health protection. However, DTC genetic tests purchased through online ordering are difficult to supervise by any agency. Adequately protecting individuals against questionable testing kits calls for international vigilance and comprehensive measures by the international community. For Europe, it is important to rank the regulation of DTC genetic tests on the European regulatory agenda.
Direct-to-consumer (DTC) genetic tests have aroused controversy. Critics have argued many of the tests are not backed by scientific evidence, misguide their customers and should be regulated more stringently. Proponents suggest that finding out genetic susceptibilities for diseases could encourage healthier behaviours and makes the results of genetics research available to the public. This paper reviews the state of play in DTC genetic testing, focusing on tests identifying susceptibilities for lifestyle-related diseases. It will start with mapping the market for the tests. The paper will review (1) research on the content of the online marketing of DTC tests, (2) studies on the effects of DTC genetic tests on customers and (3) academic and policy proposals on how to regulate the tests. Current studies suggest that the marketing of DTC genetic tests often exaggerates their predictive powers, which could misguide consumers. However, research indicates that the tests do not seem to have major negative effects (worry and confusion) but neither do they engender positive effects (lifestyle change) on current users. Research on regulation of the tests has most commonly suggested regulating the marketing claims of the companies. In conclusion, the risks and benefits of DTC genetic tests are less significant than what has been predicted by critics and proponents, which will be argued reflects broader historical trends transforming health and medicine.
Goddard, K A B; Robitaille, J; Dowling, N F; Parrado, A R; Fishman, J; Bradley, L A; Moore, C A; Khoury, M J
Recent years have seen increased concern about direct-to-consumer (DTC) genetic testing (i.e., the sale and use of genetic tests without involving a health care provider). Numerous professional organizations have developed policies in this area. However, little systematic evidence exists to inform public policy about these tests. We conducted a systematic search to identify genetic tests that are sold DTC without involving a health care provider. We evaluated the practices of companies offering DTC genetic tests for risk of thrombosis using criteria from multiple sources and a minimal set of key practices. We identified 84 instances of currently available health-related DTC genetic tests sold on 27 Web sites; the most common were for pharmacogenomics (12), risk of thrombosis (10), and nutrigenomics (10). For the DTC genetic tests for risk of thrombosis, we found low adherence to recommendations. Online information was frequently incomplete and had low agreement with professional recommendations. Our findings document the rapid growth in the availability of health-related DTC genetic tests and highlight the need to improve the delivery of DTC genetic tests. A major implication of this study is the need for the scientific and medical community to develop consistent recommendations to increase their impact. Copyright 2008 S. Karger AG, Basel.
Hall, Taryn O; Renz, Anne D; Snapinn, Katherine W; Bowen, Deborah J; Edwards, Karen L
To determine if awareness of, interest in, and use of direct-to-consumer (DTC) genetic testing is greater in a sample of high-risk individuals (cancer cases and their relatives), compared to controls. Participants were recruited from the Northwest Cancer Genetics Network. A follow-up survey was mailed to participants to assess DTC genetic testing awareness, interest, and use. One thousand two hundred sixty-seven participants responded to the survey. Forty-nine percent of respondents were aware of DTC genetic testing. Of those aware, 19% indicated interest in obtaining and testing. Additional information supplied by respondents who reported use of DTC genetic tests indicated that 55% of these respondents likely engaged in clinical genetic testing, rather than DTC genetic testing. Awareness of DTC genetic testing was greater in our sample of high-risk individuals than in controls and population-based studies. Although interest in and use of these tests among cases in our sample were equivalent to other population-based studies, interest in testing was higher among relatives and people who self-referred for a registry focused on cancer than among cases and controls. Additionally, our results suggest that there may be some confusion about what constitutes DTC genetic testing.
Gunter, Barrie; Dickinson, Roger; Matthews, Julian; Cole, Jennifer
Purpose: In the UK, advertising of infant formula products direct to consumers is not permitted. These products must be used on the recommendation of suitably qualified health or medical professionals. The aim of this study is to examine formula manufacturers' web sites to ascertain whether these are used as alternative forms of advertising that…
Becker, Sara J
Fewer than one in 10 adolescents with substance use disorders (ASUDs) will receive specialty treatment, and even fewer will receive treatment designated as evidence-based practice (EBP). Traditional efforts to increase the utilization of EBP by ASUDs typically focus on practitioners-either in substance use clinics or allied health settings. Direct-to-consumer (DTC) marketing that directly targets parents of ASUDs represents a potentially complementary paradigm that has yet to be evaluated. The current study is the first to evaluate the relevance of a well-established marketing framework (the Marketing Mix) and measurement approach (measurement of perceived service quality [PSQ]) with parents of ASUDs in need of treatment. A mixed-methods design is employed across three study phases, consistent with well-established methods used in the field of marketing science. Phase 1 consists of formative qualitative research with parents (and a supplementary sample of adolescents) in order to evaluate and potentially adapt a conceptual framework (Marketing Mix) and measure of PSQ. Phase 2 is a targeted survey of ASUD parents to elucidate their marketing preferences, using the adapted Marketing Mix framework, and to establish the psychometric properties of the PSQ measure. The survey will also gather data on parents' preferences for different targeted marketing messages. Phase 3 is a two-group randomized controlled trial comparing the effectiveness of targeted marketing messages versus standard clinical information. Key outcomes will include parents' ratings of PSQ (using the new measure), behavioral intentions to seek out information about EBP, and actual information-seeking behavior. The current study will inform the field whether a well-established marketing framework and measurement approach can be used to increase demand for EBP among parents of ASUDs. Results of this study will have the potential to immediately inform DTC marketing efforts by professional organizations
Wasson, Katherine; Sanders, Tonya Nashay; Hogan, Nancy S; Cherny, Sara; Helzlsouer, Kathy J
Little is known about the decisions and perspectives of participants undergoing direct-to-consumer genetic testing (DTCGT). The aims of this study were to examine the views, attitudes and decision-making factors of primary care patients regarding DTCGT. Their experience of and reactions to testing also emerged during the study. In this longitudinal, qualitative study, 20 primary care patients participated in DTCGT and individual interviews: (1) prior to testing after the informed consent session, (2) after receiving results, (3) 3 months post-test, and (4) 12 months post-test. Interviews included open-ended questions and all transcripts were analyzed using grounded theory, constant comparison methods. Five key themes emerged from data analysis as participants underwent DTCGT and reflected on their decision over time: (1) limited concerns about DTCGT, (2) motivations for testing, (3) expectations of testing, (4) understanding of results, and (5) impact of testing and results. While a few participants expressed concerns before testing, participants were motivated to test by curiosity, gaining actionable knowledge, and altruism. Most were uncertain of what to expect from DTCGT and needed assistance in understanding results. While many reported testing had no significant impact on them, being relieved or pleased after testing was the most common emotional effect. Notably, a few participants made positive health changes in response to testing. Given the paucity of information about primary care patients and DTCGT, this study adds more in-depth information to the emerging research on how such participants' view, make decisions about, experience and react to DTCGT over time. Because uncertainty remains about the accuracy of DTCGT, the response of primary care patients to this testing requires further investigation.
Agurs-Collins, Tanya; Ferrer, Rebecca; Ottenbacher, Allison; Waters, Erika A; O'Connell, Mary E; Hamilton, Jada G
Although the availability of direct-to-consumer (DTC) genetic testing has increased in recent years, the general public's awareness of this testing is not well understood. This study examined levels of public awareness of DTC genetic testing, sources of information about testing, and psychosocial factors associated with awareness of testing in the USA. Data were obtained from the nationally representative 2013 U.S. Health Information National Trends Survey. Guided by a social-cognitive conceptual framework, univariable and multivariable logistic regressions were conducted to identify factors associated with awareness of DTC genetic tests. Of 3185 participants, 35.6% were aware of DTC genetic tests, with the majority learning about these tests through radio, television, and the Internet. In the final adjusted model, participants with annual incomes of $99,999 or less had lower odds of being aware of DTC genetic testing (ORs ranging from 0.46-0.61) than did those participants with incomes of $100,000 or more. The odds of awareness of DTC genetic tests were significantly higher for those who actively seek cancer information (OR=1.91, 95% CI=1.36-2.69), use the Internet (OR=1.81, 95% CI=1.05-3.13), and have high numeracy skills (OR=1.67, 95% CI=1.17-2.38). It will be critical for healthcare researchers and practitioners to understand predictors and consequences of the public's awareness of DTC genetic tests, as well as how such awareness may translate into DTC genetic testing uptake, health behavior change, and ultimately disease prevention.
This commentary discusses pertinent issues from Hyosun Kim's paper on online prescription drug promotion. The study is well-designed and the findings highlight some of the consequences of the Food and Drug Administration's (FDA's) decision to deregulate online advertising of prescription drugs. While Kim's findings confirm some of the early concerns, they also provide a perspective of implementation challenges in the ever-changing technological environment. © 2016 by Kerman University of Medical Sciences.
Schenker, Yael; Arnold, Robert M; London, Alex John
Advertising by health care institutions has increased steadily in recent years. While direct-to-consumer prescription drug advertising is subject to unique oversight by the Federal Drug Administration, advertisements for health care services are regulated by the Federal Trade Commission and treated no differently from advertisements for consumer goods. In this article, we argue that decisions about pursuing health care services are distinguished by informational asymmetries, high stakes, and patient vulnerabilities, grounding fiduciary responsibilities on the part of health care providers and health care institutions. Using examples, we illustrate how common advertising techniques may mislead patients and compromise fiduciary relationships, thereby posing ethical risks to patients, providers, health care institutions, and society. We conclude by proposing that these risks justify new standards for advertising when considered as part of the moral obligation of health care institutions and suggest that mechanisms currently in place to regulate advertising for prescription pharmaceuticals should be applied to advertising for health care services more broadly.
Serour, G I; Dickens, B M
This article presents findings and recommendations of an international conference held in Cairo, Egypt in 2003 concerning issues of ethical practice in how information is provided to and by medical practitioners. Professional advertising to practitioners and the public is necessary, but should exclude misrepresentation of qualifications, resources, and authorship of research papers. Medical institutions are responsible for how staff members present themselves, and their institutions. Medical associations, both governmental licensing authorities and voluntary societies, have powers and responsibilities to monitor professional advertisement to defend the public interest against deception. Medical journals bear duties to ensure authenticity of authorship and integrity in published papers, and the scientific basis of commercial advertisers' claims. A mounting concern is authors' conflict of interest. Mass newsmedia must ensure accuracy and proportionality in reporting scientific developments, and product manufacturers must observe truth in advertising, particularly in Direct-to-Consumer advertising. Consumer protection by government agencies is a continuing responsibility.
Rubin, P H
Pharmaceutical companies have greatly increased their level of "direct-to-consumer" (DTC) advertising in recent years. For 1998, estimates are that over $1.1 billion was spent on this form of advertising, increased from $850 million in 1997 and $600 million in 1996. In 1998, 84 separate drugs were advertised to consumers. The impetus was a decision in August of 1997 by the Food and Drug Administration to reduce the restrictions on DTC advertising on television. As a result, such ads have become very common on TV, and 32 products were advertised on TV in 1998. Pharmaceutical companies advertise because they think that advertising will make money for them. But how will this make money? It will make money by providing consumers with the information they need to make proper decisions about medication. That is, DTC advertising is profitable exactly because it empowers consumers and enables them to purchase useful drugs. The goals of advertising companies and consumers are both for consumers to have information about the most beneficial drug for particular conditions, and so advertising is beneficial both to manufacturers and to consumers. This article describes emerging trends in DTC within the context of the life sciences sector.
Semin, Semih; Aras, Şahbal; Guldal, Dilek
Abstract While several major problems concerning drugs occur in the world, the attempts to direct‐to‐consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives’ work efficiency; drug reimbursement restrictions; and the escalating role of the Internet in the consumer market. Some of the main disadvantages of the DTCA are: increasing drug expenditures, unnecessary drug consumption and adverse effect risks. Even though the influence of pharmaceuticals on health services and the economy hold the same importance in the developed and developing countries, its negative consequences have increased by encompassing developing countries in its grip. Therefore, in this review, using Turkey as an example, the situation of direct‐to‐consumer advertisements in developing countries is analysed in relation with developed countries. PMID:17324191
Advertising agencies are the most significant organizations in the development of advertising and marketing worldwide. An advertising agency is an independent service company, composed of business, marketing and creative people, who develop, prepare, and place advertising in advertising media...... for their clients, the advertisers, who are in search of customers for their goods and services. Agencies thus mediate between three different but interlocking social groups: industry, media, and consumers. The history of advertising is largely the history of the advertising agencies that have served the needs....... This article is concerned with the origins, early developments, organization, compensation arrangements, and accounts of contemporary full-service advertising agencies....
Park, Jin Seong; Ahn, Ho-Young Anthony; Haley, Eric John
Based on a survey of prescription drug users (N = 408), this study revealed that: (a) the frequency of consumers' personal experience of prescription medicine adverse reactions negatively related to the extent of their optimistic bias about the chances of such events, (b) consumers' perceived personal control over adverse reactions positively related to optimistic bias, and (c) optimistic bias related more negatively to intentions to seek risk information when consumer skepticism toward direct-to-consumer advertising was high. When skepticism was low to average, optimistic bias did not inhibit such intentions. Implications and recommendations for the practice of direct-to-consumer advertising are provided.
Full Text Available The last several years have seen an increase inthe number of direct to consumer advertisements by pharmaceutical companies.Direct to Consumer advertisements (DTC means targeting the end consumerthrough advertisements on television, radio, in newspapers, magazines, and theInternet. The qualitative study presents data and supports the need for a future quantitative study toask physicians and consumers their opinions on whether pharmaceutical companiesshould be allowed to advertise directly to the end consumer. This article reviewsthe literature on this controversial topic, supporting the need to explore thereserach questions in greater detail. A review of the literature suggests thereis financial motivation on the part of the pharmaceutical companies to increasetheir sales by advertsing directly to the end consumer as opposed to performingan educational service to the consumer.
Shapiro, M F
As Dr. Joel Lexchin makes painfully obvious in this issue (see pages 351 to 356), regulatory processes governing pharmaceutical advertising in Canada and elsewhere are seriously compromised. However, the remedial measures Lexchin proposes are not sufficient. Financial sanctions against improper advertising are likely to be regarded by manufacturers as the cost of doing business, and any regulatory body that includes drug industry representatives or individuals receiving financial support from the drug industry cannot be genuinely independent. Moreover, manufacturers are now using promotional strategies that are particularly difficult to regulate. These include providing drugs at lower than the usual cost to ensure their inclusion in managed-care formularies, and using direct-to-consumer advertising to take advantage of the public's lack of sophistication in interpreting scientific evidence. Our best hope of counteracting the power and influence of the drug industry lies in regulation by government agencies, whose interest is the protection of the public.
Mongiovi, Jennifer; Clarke Hillyer, Grace; Basch, Corey H.; Ethan, Danna; Hammond, Rodney
Background: Although prescriptions are dispensed at discretion of medical professionals, many pharmaceutical companies use direct-to-consumer (DTC) advertising to increase sales. Over-the-counter (OTC) medications are similarly marketed. Methods: We examined the content of advertisements in 38 issues of 9 popular US women’s fashion magazines. We evaluated target audience, health condition, product availability, message appeal, target to females, and mention of potential...
History of internet advertising, types of internet advertising. Banner advertising, methods of payment for banner advertising, formats and technologies. Internet media market in Czech Republic, portals, servers, media agents, media agencies, SPIR association. Banner campaign, its planning, execution and evaluation. Videobanner campaign Nivea For Men, searching for the most effective format for videoadvertising on the internet.
Goldfarb, Avi; Tucker, Catherine Elizabeth
This chapter explores what makes online advertising different from traditional advertising channels. We argue that online advertising differs from traditional advertising channels in two important ways: measurability and targetability. Measurability is higher because the digital nature of online advertising means that responses to ads can be tracked relatively easily. Targetability is higher because data can be automatically tracked at an individual level, and it is relatively easy to show di...
Zamanzadeh, Ben; Ashish, Naveen; Ramakrishnan, Cartic; Zimmerman, John
We present the concept of Semantic Advertising which we see as the future of online advertising. Semantic Advertising is online advertising powered by semantic technology which essentially enables us to represent and reason with concepts and the meaning of things. This paper aims to 1) Define semantic advertising, 2) Place it in the context of broader and more widely used concepts such as the Semantic Web and Semantic Search, 3) Provide a survey of work in related areas such as context matchi...
Misleading advertising The topic of this rigorous thesis is "Misleading advertising". The theme of the thesis is current and attractive, because everybody comes across the advertising all the time and thus the advertisement influents each of our lives. One of the motives for writing this rigorous thesis was to mediate understanding of problems concerning with the misleading advertising and the unfair competition. The rigorous thesis is divided into six chapters. The first chapter deals with t...
The data presented by Joel Weissman and colleagues and by Robert Dubois do not justify the conclusions that the effects of pharmaceutical promotion are beneficial. Among consumers of direct-to-consumer advertising (Weissman and colleagues), those heavily influenced by such promotion were no more likely than others were to have new conditions diagnosed or confirmed and were much less likely to have laboratory studies ordered or lifestyle changes recommended. A second study (Dubois) arguing that drug advertising improves the appropriateness of prescribing relies on unconvincing ecological arguments. A greater presence of noncommercial, public health-oriented communication would make a more useful and cost-effective impact on the nation's health.
Larson, Robin J; Schwartz, Lisa M; Woloshin, Steven; Welch, H Gilbert
Many academic medical centers have increased their use of advertising to attract patients. While the content of direct-to-consumer pharmaceutical advertisements (ads) has been studied, to our knowledge, advertising by academic medical centers has not. We aimed to characterize advertising by the nation's top academic medical centers. We contacted all 17 medical centers named to the US News & World Report 2002 honor roll of "America's Best Hospitals" for a semistructured interview regarding their advertising practices. In addition, we obtained and systematically analyzed all non-research-related print ads placed by these institutions in their 5 most widely circulating local newspapers during 2002. Of the 17 institutions, 16 reported advertising to attract patients; 1 stated, "We're just word of mouth." While all 17 centers confirmed the presence of an institutional review board process for approving advertising to attract research subjects, none reported a comparable process for advertising to attract patients. We identified 127 unique non-research-related print ads for the 17 institutions during 2002 (mean, 7.5; range, 0-39). Three ads promoted community events with institution sponsorship, 2 announced genuine public services, and 122 were aimed at attracting patients. Of the latter group, 36 ads (29.5%) promoted the medical center as a whole, while 65 (53.3%) promoted specific clinical departments and 21 (17.2%) promoted single therapeutic interventions or diagnostic tests. The most commonly used marketing strategies included appealing to emotions (61.5%), highlighting institution prestige (60.7%), mentioning a symptom or disease (53.3%), and promoting introductory lectures or special offers likely to lead to further business (47.5%). Of the 21 ads for single interventions, most were for unproved (38.1%) or cosmetic (28.6%) procedures. While more than half of these ads presented benefits, none quantified their positive claims and just 1 mentioned potential harms
Sergei Kovbasyuk; Marco Pagano
Speculators often advertise arbitrage opportunities in order to persuade other investors and thus accelerate the correction of mispricing. We show that in order to minimize the risk and the cost of arbitrage an investor who identifies several mispriced assets optimally advertises only one of them, and overweights it in his portfolio; a risk-neutral arbitrageur invests only in this asset. The choice of the asset to be advertised depends not only on mispricing but also on its "advertisability" ...
The aim of this project was to get an understanding of how companies adopt mobile as an advertising medium. The literature review aided in framing a draft of the factors that affect mobile advertising adoption and possible forms of mobile advertising. Considering the scope of the thesis work, branding strategy, service costs, personalization and privacy and platform were considered to be the factors that could affect the mobile advertising adoption. A few possible forms on mobile device we...
von Tigerstrom, Barbara
There are widespread concerns with the ways in which 'unproven' stem cell therapies are advertised to patients. This article explores the potential and limits of using laws that regulate advertising and promotion as a tool to address these concerns. It examines general consumer protection laws and laws and policies on advertising medical products and services, focusing on the USA, Canada and Australia. The content of existing laws and policies covers most of the marketing practices that cause concern, but several systemic factors are likely to limit enforcement efforts. Potential reforms in Australia that would prevent direct-to-consumer advertising of autologous cell therapies are justified in principle and should be considered by other jurisdictions, but again face important practical limits to their effectiveness.
Bradford, W David; Kleit, Andrew N
Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.
Kopp, S W; Bang, H K
As pharmaceutical companies began to advertise prescription drugs directly to consumers as well as to physicians, understanding the impact of benefit and risk information in drug advertising on physicians and consumers has become more critical. This paper reviews previous empirical studies that examined the content of benefit and risk information in drug advertising and its potential effects on physicians' subsequent prescribing behaviors. It also reviews studies that investigated how consumers process information on a drug's efficacy and side effects. Based on the findings of these studies, implications are discussed for effective marketing information development as well as for government regulation.
This paper clarifies advertising systems unique to Japan. As typical of Japanese advertising systems, advertising expression tend to adopt soft sell and transformational type. The advertising expression is explained not only by the cultural value but also marketing behavior of advertisers and the characteristics of Advertising transactions. As to marketing behavior channel-oriented marketing behavior has an impact on advertising expressions. As to characteristics of Advertising transactions, ...
Illes, Judy; Kann, Dylan; Karetsky, Kim; Letourneau, Phillip; Raffin, Thomas A; Schraedley-Desmond, Pamela; Koenig, Barbara A; Atlas, Scott W
Self-referred imaging is one of the latest health care services to be marketed directly to consumers. Most aspects of these services are unregulated, and little is known about the messages in advertising used to attract potential consumers. We conducted a detailed analysis of print advertisements and informational brochures for self-referred imaging with respect to themes, content, accuracy, and emotional valence. Forty print advertisements from US newspapers around the country and 20 informational brochures were analyzed by 2 independent raters according to 7 major themes: health care technology; emotion, empowerment, and assurance; incentives; limited supporting evidence; popular appeal; statistics; and images. The Fisher exact test was used to identify significant differences in information content. Both the advertisements and the brochures emphasized health care and technology information and provided assurances of good health and incentives to self-refer. These materials also encouraged consumers to seek further information from company resources; virtually none referred to noncomplying sources of information or to the risks of having a scan. Images of people commonly portrayed European Americans. We found statistical differences between newspaper advertisements and mailed brochures for references to "prevalence of disease" (Padvertisements (n = 15) and 25% of the brochures (n = 5). Direct-to-consumer marketing of self-referred imaging services, in both print advertisements and informational brochures, fails to provide prospective consumers with comprehensive balanced information vital to informed autonomous decision making. Professional guidelines and oversight for advertising and promotion of these services are needed.
Simon P. Anderson; Régis Renault
Empirical evidence suggests that most advertisements contain little direct informa- tion. Many do not mention prices. We analyze a firm'ss choice of advertising content and the information disclosed to consumers. A firm advertises only product informa- tion, price information, or both; and prefers to convey only limited product information if possible. Extending the "persuasion" game, we show that quality information takes precedence over price information and horizontal product information.T...
Rhodes, Andrew; Wilson, Chris M
There is widespread evidence that some firms use false advertising to overstate the value of their products. We consider a model in which a policymaker is able to punish such false claims. We characterize an equilibrium where false advertising actively influences rational buyers, and analyze the effects of policy under different welfare objectives. We establish precise conditions where policy optimally permits a positive level of false advertising, and show how these conditions vary intuitive...
Future Challenges and Opportunities in Online Prescription Drug Promotion Research; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
Brian G. Southwell
Full Text Available Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions.
Future Challenges and Opportunities in Online Prescription Drug Promotion Research Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".
Southwell, Brian G; Rupert, Douglas J
Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. © 2016 by Kerman University of Medical Sciences.
Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues).
Genomic population research increases the possibility of finding genetic coding anomalies that are not the primary object of research but may have significance for the current and future medical care of research participants and progeny. The December 2013 Report of the Presidential Commission for the Study of Bioethical Issues (Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (http://bioethics.gov/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf)) recommends that a researcher anticipate these findings and make a plan that addresses which findings will be communicated to research participants and how. Following these recommendations will be disruptive for both investigators and institutional review boards (IRBs) until the research community reaches consensus, or a mechanism for evolving consensus, on which results should be returned to research participants. A protocol-by-protocol approach, though laborious, makes sense for both investigators and IRBs as the research community thinks through the implications of genomic research. Epidemiologists will note that discussion of the return of results and the plan for communicating findings should be included in both the participant consent agreement and the research protocol submitted to the IRB. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: email@example.com.
Miller, Sandra K.
The individualized learning package for secondary consumer education deals with consumer buying as influenced by advertising. The teacher's section of the package contains a statement of purpose and instructional objectives. Equipment and materials (specific textbooks, audiovisual aids, and sources for sample post-test advertisements) needed for…
Advertising should be viewed as a sales-building investment and not simply an element of business outlay that actually is a completely controllable expense. Suggestions deal with the sales budget, profiling the store and its customers, advertising media, promotional ideas, and consumer protection. (LBH)
A heavily illustrated discussion of the ways in which men and women are portrayed in advertisements is presented. The three essays which precede the 56 pages of illustrations discuss gender expressions, characteristics of public and private pictures, and gender commercials. The author notes that advertisements do not depict how men and women…
Glinert, Lewis H; Schommer, Jon C
Considerable attention has been afforded to analyzing the content of and assessing consumers' reaction to print direct-to-consumer drug ads, but not so for televised ads. To determine whether advertisements with different risk severity and risk presentation would significantly affect viewers' (1) recall of information contained in the advertisement, (2) evaluation of the advertisement, and (3) perceptions of the advertised product's risks. Data were collected from a sample of 135 first-year pharmacy students at a Midwestern college of pharmacy. After viewing 1 of the 6 advertisements designed for this study, participants were asked to complete a self-administered survey. Chi-square and analysis of variance were used to analyze the data. A 2x3 between subjects design was used to test the effects of 2 levels of risk severity (high- vs low-risk severity) and 3 levels of risk presentation (original ad containing integrated risk message, deintegrated risk message/dual modality using male voice-over, deintegrated risk message/dual modality using female voice-over). Results of analysis of variance procedures revealed that deintegrating risk information by placing it at the end of the advertisement and the use of captions in addition to oral messages (dual modality) (1) improved the recall of general and specific side effect information, (2) led to a perception that the advertisement had greater informational content, (3) resulted in lower Advertisement Distraction, and (4) lessened cognitive and affective aspects of information overload for the advertisement containing the high-risk severity medication. However, this pattern of findings was not found for the low-risk severity medication. Alternative methods for presenting risk information in direct-to-consumer ads affected some aspects of information recall and advertisement evaluation, but were not shown to affect risk perceptions regarding the advertised products.
Bell, Robert A.; Taylor, Laramie D.; Kravitz, Richard L.
Objective To examine how online depression support group members respond to direct-to-consumer (DTC) antidepressant advertising. Methods Survey of 148 depression forum members, administered via an online questionnaire. Results Chronicity was high, as 79.1% had received a diagnosis of depression 3 or more years earlier. Respondents reported seeing advertisements for an average of 4.3 of 7 brands investigated. A majority rated the information quality of these advertisements as “poor” or “fair.” Attitudes toward antidepressant advertisements were neutral (mean: 2.96 on a 5-point scale). More than half (52.4%) visited official websites provided in these advertisements, 39.9% had talked with a doctor after seeing an advertisement, 20.3% made an advertisement-induced prescription request, and 25.7% said these advertisements reminded them to take their antidepressants. Amount of attention given to these advertisements correlated positively with belief in the brain chemical imbalance causal model, but belief in this model did not predict prescription requests. Conclusion Awareness of DTC antidepressant advertisements is high among individuals with depression, but so is skepticism. Practice Implications Among members of an on-line support group, these advertisements encourage patient-doctor dialogue, prescription requests, and adherence, but might also reduce the acceptability of psychotherapy and encourage doctor switching in a small number of patients. PMID:20176456
Norris, Rebecca L; Bailey, Rachel L; Bolls, Paul D; Wise, Kevin R
This experiment explored how the emotional tone and visual complexity of direct-to-consumer (DTC) drug advertisements affect the encoding and storage of specific risk and benefit statements about each of the drugs in question. Results are interpreted under the limited capacity model of motivated mediated message processing framework. Findings suggest that DTC drug ads should be pleasantly toned and high in visual complexity in order to maximize encoding and storage of risk and benefit information.
Díaz Pinedo, Edilfredo Eliot
Intelligent Advertisement diseña e implementa un sistema de publicidad para dispositivos móviles en un centro comercial, donde los clientes reciben publicidad de forma pasiva en sus dispositivos mientras están dentro.
Cornière (de), Alexandre
Search engines enable advertisers to target consumers based on the query they have entered. In a framework with horizontal product differentiation, imperfect product information and in which consumers incur search costs, I study a game in which advertisers have to choose a price and a set of relevant keywords. The targeting mechanism brings about three kinds of efficiency gains, namely lower search costs, better matching, and more intense product market price-competition. A monopolistic searc...
The thesis concerns itself with alcohol advertising. Alcohol is the most widespread habit-forming substance, yet its consumption is permitted in most countries all around the world, possibly restricted by the age of consumers only. Drinking alcohol cannot be either regulated or prohibited today. It has become commonplace for the majority of our lives. Being aware of its apparent risks, however, there is an effort to regulate at least alcohol advertising. The main objective of this work was to...
According to Kotler’s definition, advertising is “any paid form of non-personal presentation and promotion of ideas, goods and services through mass media such as newspapers, magazines, television or radio by an identified sponsor”.
Mongiovi, Jennifer; Clarke Hillyer, Grace; Basch, Corey H; Ethan, Danna; Hammond, Rodney
Background: Although prescriptions are dispensed at discretion of medical professionals, many pharmaceutical companies use direct-to-consumer (DTC) advertising to increase sales. Over-the-counter (OTC) medications are similarly marketed. Methods: We examined the content of advertisements in 38 issues of 9 popular US women's fashion magazines. We evaluated target audience, health condition, product availability, message appeal, target to females, and mention of potential side effects and benefits. Results: Sixty total medication advertisements were identified, 58.3% (95% CI: 45.8, 70.8) for prescription products. In magazines targeted to non-Hispanic Whites, >65% of advertisements were for OTC medications whereas 80% (95% CI: 66.7, 94.5) of advertisements found in Black/Latina magazines were for prescription medications. The rational appeal was used most commonly in non-Hispanic White magazines (75.9%; 95% CI: 60.3, 91.5). Emotional appeal was featured more often in prescription advertisements magazines (60.0; 95% CI:43.8, 76.2) compared to OTC (8.0; 95% CI: -2.6, 18.6). Conclusion: Although emotional appeal may be effective for selling medication to women, it often does not completely inform consumers of potential risks.
Culture, Product Advertising, and Advertising Agency Operations. ... As a means of telling the market about a new product, advertising persuades and reminds the audience of their continuous support of the ... AJOL African Journals Online.
Kalokairinou, Louiza; Borry, Pascal; Howard, Heidi Carmen
Direct-to-consumer (DTC) genetic tests (GT) have provoked criticism over their potential adverse impact on public health. The European Parliament called for a ban on DTC advertising of GT during the debate for the adoption of a European Regulation on in vitro diagnostic medical devices. This proposal, however, was not ultimately retained in the final text. Instead, the regulation includes an article prohibiting misleading claims for this kind of advertising. These two different approaches raise questions about the optimal degree of regulation. Herein, we provide an overview of the ways GT have been advertised and related ethical issues. Subsequently, the laws regulating the advertising of GT at the European Union and national level are examined. Finally, recent regulatory developments are discussed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Advertising has come a long way today. More and more new medium is being explored each day to make a successful advertising campaign. Internet that has in recent times picked up as advertising medium has become the favorite of the advertiser in no time. Online advertisement, also called internet advertising uses the internet to deliver promotional marketing messages to consumers. It includes email marketing, search engine marketing, social media marketing, many types of display advertising (i...
S, venkatesh; N, senthilkumar
In global advertising ‘humor’ is the most effective emotion used in advertising compared to other emotional appeals. Advertisers and researchers more interested in Humor in advertising for more than 100 years. But there is no review paper for Impact of humor in advertising till twenty two years of time, in between period there was lot of research outcomes published about humor in advertising. The purpose of this paper to get detailed review about Impact of humor in advertising for 40 years an...
Vater, Laura B; Donohue, Julie M; Arnold, Robert; White, Douglas B; Chu, Edward; Schenker, Yael
Although critics have expressed concerns about cancer center advertising, analyses of the content of these advertisements are lacking. To characterize the informational and emotional content of direct-to-consumer cancer center advertisements. Content analysis. Top U.S. consumer magazines (n = 269) and television networks (n = 44) in 2012. Types of clinical services promoted; information provided about clinical services, including risks, benefits, costs, and insurance availability; use of emotional advertising appeals; and use of patient testimonials were assessed. Two investigators independently coded advertisements using ATLAS.ti, and κ values ranged from 0.77 to 1.00. A total of 102 cancer centers placed 409 unique clinical advertisements in top media markets in 2012. Advertisements promoted treatments (88%) more often than screening (18%) or supportive services (13%). Benefits of advertised therapies were described more often than risks (27% vs. 2%) but were rarely quantified (2%). Few advertisements mentioned coverage or costs (5%), and none mentioned specific insurance plans. Emotional appeals were frequent (85%), evoking hope for survival (61%), describing cancer treatment as a fight or battle (41%), and inducing fear (30%). Nearly one half of advertisements included patient testimonials, which were usually focused on survival, rarely included disclaimers (15%), and never described the results that a typical patient may expect. Internet advertisements were not included. Clinical advertisements by cancer centers frequently promote cancer therapy with emotional appeals that evoke hope and fear while rarely providing information about risks, benefits, costs, or insurance availability. Further work is needed to understand how these advertisements influence patient understanding and expectations of benefit from cancer treatments. National Institutes of Health.
Sandage, C. H.; Fryburger, Vernon
The social and economic functions of advertising, its role in business, how it works, and how it is planned and created are the subject of this textbook. Sections include basic values and functions, background for planning advertising strategy, the advertising message, advertising media, testing advertising effectiveness, and the advertising…
Pharmaceutical companies use social media such as Facebook and Twitter more and more to advertise their products. Advertising of medicinal products especially in social media is a critical issue confronting patient protection, competition law and ethical concerns in direct-to-consumer advertising. Advertising in the World Wide Web must take into account national and international regulations, depending on which user from which country will have access to the information posted. Different legal requirements, if any, regulate the advertising of medicinal products. This paper discusses, challenges and compares the requirements and regulations of advertising medicinal products in social media, such as Facebook, in the United States on a federal level and the European Union with Germany as a reference Member State. Social media are very active and fast moving. Therefore, it is challenging and necessary at the same time to set guidelines and regulations for the use of social media in drug advertising. This paper is a first step toward promoting an international, consistent approach when talking about regulating advertising of medicinal products in social media.
Harper, Joseph; And Others
Presents a mathematical model for simulating a newspaper financial system. Includes the effects of advertising and circulation for predicting advertising linage as a function of population, income, and advertising rate. (RL)
The Bachelor Thesis Humour in advertisement is focused on creating humorous advertisements. The Thesis is divided into theoretical and practical part. The theoretical part is about advertisement, psychology of advertisement, emotions and emotional appeals that are used in advertising, primarily appeal humour. The practical part includes analysis of the survey focused on the effectiveness of humour in advertisements, analysis of selected campaign and the results of own survey.
DeLorme, Denise E; Huh, Jisu; Reid, Leonard N
This study was conducted to provide additional evidence on how consumers behave following direct-to-consumer (DTC) advertising exposure and to determine if there are differences in ad-prompted acts (drug inquiry and drug requests) between different age groups (i.e., older, mature, and younger adults). The results suggest that younger, mature, and older consumers are all moved to act by DTC drug ads, but that each age group behaves in different ways. Somewhat surprisingly, age was not predictive of ad-prompted behavior. DTC advertising was no more effective at moving older consumers to behave than their younger counterparts. These results suggest that age does not matter that much when it comes to the "moving power" of prescription drug advertising, even though research indicates that older consumers are more vulnerable to the persuasive effects of communication.
Jugenheimer, Donald W.
States that although many advertisers have intentions of utilizing the Internet for advertising, which can provide specific audience targeting and buyer/seller interactivity, few have been successful. Explains advantages and disadvantages of using the Internet for advertising purposes. Cites special problems with Internet advertising and successes…
Accompanied with the widespread commerce,the advertisement translation unavoidably will be a hot spot again.This paper will discuss usage and translation of pun in the advertisement translation.It will explain the definition of advertisement as well as pun and then give examples about the usage of pun in advertisement.
Accompanied with the widespread commerce,the advertisement translation unavoidably will be a hot spot again. This paper will discuss usage and translation of pun in the advertisement translation.It will explain the definition of advertisement as well as pun and then give examples about the usage of pun in advertisement.
Keisuke Hattori; Keisaku Higashida
This paper builds a model of strategic misleading advertising in duopolistic markets with horizontal product differentiation and advertising externality between firms. We investigate the effects of regulating misinformation on market competition, behaviour of firms, and social welfare. We show that the degree of advertising externality and the magnitude of advertising costs are crucial for determining the welfare effects of several regulations, including prohibiting misleading advertising, ed...
The article replies to the question, whether the advertisement can exist without ethical principles or ethics should be the basis of the advertisement. One can say that the ethical opinion of the advertisement does not depend on content and the form of advertising content exclusively, but also on recipientís consciousness. The advertisement appeals to the emotions more than to the intellect, thus restricting the area of conscious and based on rational premises choice, so it is morally bad. It...
Matthew N. O. Sadiku*, Shumon Alam, Sarhan M. Musa
Internet advertising (IA) is using the Internet to market products and services to a large audience. In the current era of Internet commerce, companies have chosen to use Internet advertising and the trend is irreversible. The goal of Internet advertising is to drive customers to your website. Understanding some key concepts of Internet advertising is crucial to creating a strategy that will suit one’s business. This paper provides a brief introduction to Internet or online advertising.
Full Text Available The article replies to the question, whether the advertisement can exist without ethical principles or ethics should be the basis of the advertisement. One can say that the ethical opinion of the advertisement does not depend on content and the form of advertising content exclusively, but also on recipients consciousness. The advertisement appeals to the emotions more than to the intellect, thus restricting the area of conscious and based on rational premises choice, so it is morally bad. It is not that the moral evil immanently underlines the advertisement, but it concerns the mechanisms which cause that the advertisement turns out to be effective. The only admissible form of the advertisement would be the reliable full information about the advantages and flaws of the concrete advertised product. The only admissible form of the advertisement would be the reliable full information about the advantages and defects of the concrete advertised product. The most serious difficulty connected with the ethical opinion of the advertisement is the fact that the advertisement is the indispensable link of the present economy, and everyone who accepts the free market and perceives the positives of the economic growth, should also accept the advertisement. The advertisement constitutes the element of the economic activity, so in consequence the responsibility first of all lies with enterprises for its far-reaching results.
Burkitt, Jennifer A; Saucier, Deborah M; Thomas, Nicole A; Ehresman, Crystal
Portraits typically exhibit leftward posing biases, with people showing more of their left cheek than their right. The current study investigated posing biases in print advertising to determine whether the product advertised affects the posing bias. As the posing bias may be decreasing over time, we also investigated changes in posing biases over a span of more than 100 years. The current investigation coded 2664 advertisements from two time periods; advertisements were coded for target group of advertisement (men, women, both) and posing bias (rightward, leftward, or central). Unlike other studies that typically observe a leftward posing bias, print advertisements exhibit a rightward posing bias, regardless of time-frame. Thus, print advertisements differ greatly from portraits, which may relate to the purpose of advertisements and the role of attractiveness in advertising.
YAKOUBI Mohamed Lamine
We will try to demonstrate, through the display of the various advertising creation strategies and their evolution, how the advertising communication passed from of a vision or a strategy focused on the product, to a vision focused on the brand. The first advertising strategy that was applied by advertising agencies is the＂Unique Selling Proposition＂;it focused only on the product advantages and its philosophy dominated the advertising world, throughout its various evolutions, till the nineties but this is without counting the introduction of the new advertising strategies that brought a more brand oriented philosophy to the ground.
The Bachelor Paper contains proposal and realization advertising campaign, including make charge for cost amount. The advertising campaign is made for chosen product of firm. Advertising campaign is planning by the medium of broadsheet and advertising on the Internet.
Mongiovi, Jennifer; Clarke Hillyer, Grace; Basch, Corey H.; Ethan, Danna; Hammond, Rodney
Background: Although prescriptions are dispensed at discretion of medical professionals, many pharmaceutical companies use direct-to-consumer (DTC) advertising to increase sales. Over-the-counter (OTC) medications are similarly marketed. Methods: We examined the content of advertisements in 38 issues of 9 popular US women’s fashion magazines. We evaluated target audience, health condition, product availability, message appeal, target to females, and mention of potential side effects and benefits. Results: Sixty total medication advertisements were identified, 58.3% (95% CI: 45.8, 70.8) for prescription products. In magazines targeted to non-Hispanic Whites, >65% of advertisements were for OTC medications whereas 80% (95% CI: 66.7, 94.5) of advertisements found in Black/Latina magazines were for prescription medications. The rational appeal was used most commonly in non-Hispanic White magazines (75.9%; 95% CI: 60.3, 91.5). Emotional appeal was featured more often in prescription advertisements magazines (60.0; 95% CI:43.8, 76.2) compared to OTC (8.0; 95% CI: -2.6, 18.6). Conclusion: Although emotional appeal may be effective for selling medication to women, it often does not completely inform consumers of potential risks. PMID:28058239
Kimball, Suzanne H.
An individual over age 18 can purchase a hearing aid online or through mail order if they sign a waiver declining a medical evaluation, while those under 18 are required to be seen by a physician to obtain medical consent. However, in many states there is nothing to prevent a parent or caregiver from purchasing hearing aids for their child from a…
Kochmann, Matthias; Locatis, Craig
Background: Since 2012, “Direct to Consumer” mobile teledermatology apps have become more available, relinquishing many data collection tasks normally done by healthcare professionals directly to patients. Introduction: To determine user friendliness, diagnostic quality, and service of commercially available mobile teledermatology apps. Materials and Methods: All mobile teledermatology apps available at the Apple App Store were reviewed. The two most popular mobile teledermatol...
Wright, Caroline F; Gregory-Jones, Shelley
There has been enormous interest in the recent development of consumer genomics services, but very little is known about their impact. Using publicly available information, we estimate that the market for genetic susceptibility tests for complex diseases is much smaller than previously suggested, and hence consider that regulation through restrictive statutory legislation may be excessive.
There is a large, poorly regulated international market of putative stem cell products, including transplants of processed autologous stem cells from various tissues, cell processing devices, cosmetics, and nutritional supplements. Despite the absence of rigorous scientific research in the form of randomized clinical trials to support the routine use of such products, the market appears to be growing and diversifying. Very few stem cell biologics have passed regulatory scrutiny, and authorities in many countries, including the United States, have begun to step up their enforcement activities to protect patients and the integrity of health care markets.
The question addressed in this review is whether aggregate alcohol advertising increases alcohol consumption among college students. Both the level of alcohol-related problems on college campuses and the level of alcohol advertising are high. Some researchers have concluded that the cultural myths and symbols used in alcohol advertisements have powerful meanings for college students and affect intentions to drink. There is, however, very little empirical evidence that alcohol advertising has any effect on actual alcohol consumption. The methods used in this review include a theoretical framework for evaluating the effects of advertising. This theory suggests that the marginal effect of advertising diminishes at high levels of advertising. Many prior empirical studies measured the effect of advertising at high levels of advertising and found no effect. Those studies that measure advertising at lower, more disaggregated levels have found an effect on consumption. The results of this review suggest that advertising does increase consumption. However, advertising cannot be reduced with limited bans, which are likely to result in substitution to other available media. Comprehensive bans on all forms of advertising and promotion can eliminate options for substitution and be potentially more effective in reducing consumption. In addition, there is an increasing body of literature that suggests that alcohol counteradvertising is effective in reducing the alcohol consumption of teenagers and young adults. These findings indicate that increased counteradvertising, rather than new advertising bans, appears to be the better choice for public policy. It is doubtful that the comprehensive advertising bans required to reduce advertising would ever receive much public support. New limited bans on alcohol advertising might also result in less alcohol counteradvertising. An important topic for future research is to identify the counteradvertising themes that are most effective with
Offers suggestions to high school newspaper staffs for designing effective advertisements for local businesses and then selling them to the businesses. Notes that carefully planned advertisements can increase the appeal and value of a publication. (GW)
Alina Irina GHIRVU
This paper proposes a model of advertising competition based on the Cournot oligopoly model using a dynamic system, the equilibrium points of which can be determined analytically. We consider several cases for explaining the way in which firms will adapt their own advertising volume, depending on the number and the advertising volume of their competitors, in the context of an online video game used for advertising purposes. The dynamic setup is given by online Internet connection ...
Michael P. Stone
Attorney advertising routinely targets tort victims. In this paper, a theoretical model is developed which incorporates advertising intensity, litigation costs, and an endogenous number of lawsuits. Since advertising induces victims to bring suit, it increases the level of injurer care. However, litigation costs are also incurred. At the optimum, the marginal benefit of deterrence equals the sum of the marginal costs of litigation and advertising. It is shown that even though blanket prohibit...
Egli, Alain (Autor/in)
Firms face a prisoner's dilemma when advertising in a competitive environment. In a Hotelling framework with persuasive advertisingfirms counteract this prisoner's dilemma with targeting. The firms even solve the prisoner's problem if targeted advertising is effective enough. Advertising turns from wasteful competition into profits. This is in contrast to wasteful competition as argument for regulations. A further result is maximum advertising differentiation: thefirms target their advertisin...
Пурчельянова, Н. Ю.
The essence of successful advertising is to convince people that a product is meant for them. By purchasing it, they will receive some benefit (lifestyle, status, convenience, etc.). However, when an advertising campaign is taken abroad different values as to what enhances status or gives convenience exist. These differences make the original advertising campaign defunct. It is therefore critical to any cross cultural advertising campaign that an understanding of a particular culture is acqui...
Muhlestein, David B; Wilks, Chrisanne E A; Richter, Jason P
Consumer-directed policies, including health savings accounts, have been proposed and implemented to involve individuals more directly with the cost of their health care. The hope is this will ultimately encourage providers to compete for patients based on price or quality, resulting in lower health care costs and better health outcomes. To evaluate American hospital websites to learn whether hospitals advertise directly to consumers using price or quality data. Structured review of websites of 10% of American hospitals (N=474) to evaluate whether price or quality information is available to consumers and identify what hospitals advertise about to attract consumers. On their websites, 1.3% (6/474) of hospitals advertised about price and 19.0% (90/474) had some price information available; 5.7% (27/474) of hospitals advertised about quality outcomes information and 40.9% (194/474) had some quality outcome data available. Price and quality information that was available was limited and of minimal use to compare hospitals. Hospitals were more likely to advertise about service lines (56.5%, 268/474), access (49.6%, 235/474), awards (34.0%, 161/474), and amenities (30.8%, 146/474). Insufficient information currently exists for consumers to choose hospitals on the basis of price or quality, making current consumer-directed policies unlikely to realize improved quality or lower costs. Consumers may be more interested in information not related to cost or clinical factors when choosing a hospital, so consumer-directed strategies may be better served before choosing a provider, such as when choosing a health plan.
The article analyzes the new method of mobile advertising. Advertising in mobile applications - a subspecies of mobile marketing, where advertising is distributed using mobile phones and smartphones. Ad placement is going on inside of applications and games for smartphones. It has a high potential due to the large number of mobile phone users (over 6.5 billion in 2013).
Presents a lesson plan to help students understand that political advertisements often mislead, lie, or appeal to emotion. Suggests that the lesson will enable students to examine political advertisements analytically. Includes a worksheet to be used by students to analyze individual political advertisements. (DK)
I am concerned to make the case for the rights and liberties to communicate commercial advertising messages to children. Consequenlly, I am amused by the identification of advertising with witchcraft; witches ceased to be burned a long time ago. However, this comparison, illustrates the excessive concern shown about how strangely influential advertising is.
Examines the relationship between linguistic plurality and the rationale of advertising decisions. The article presents a simple model of sales to different language groups as a function of the level of advertising in each language, language attitudes, incomes, and an advertising response function. The model is intended as a benchmark, and several…
Business Advertisements Management System The main goal of the project was to create a business advertisements management system, where users could easily create and find business advertisements. To accomplish this goal exist- ing systems were analyzed as well as their limitations. The end result is a working system which is able to store and proccess huge amount of data.
On the grounds of theoretical and empirical studies, the article analyses some interaction between the advertisement agencies and advertisement provider during the development of creative advertisement strategy. The following assumptions justifying the importance of interaction have been developed: namely, the need to integrate the knowledge and competence of advertisement agencies and advertisement provider, creativity of advertisement agencies and possible objective approach to the business...
Aikin, Kathryn J; Southwell, Brian G; Paquin, Ryan S; Rupert, Douglas J; O'Donoghue, Amie C; Betts, Kevin R; Lee, Philip K
Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight-loss drug and produced corresponding direct-to-consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between-subjects factorial design. Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. These results
Graskemper, Joseph P
Advertising in dentistry has steadily increased since the 1970s to become a leading choice of many dentists to promote their practices. The manner in which advertising progresses within the profession affects all dentists and how patients perceive dentistry as a profession. This paper presents ethical concepts that should be followed when dentists are pursuing practice promotion through advertising. It also raises questions that, hopefully, will increase attention and discussion on dental advertising. The paper concludes that ethical advertising is easily achieved by promoting patient education while not placing the dentist's self-interests ahead of the patient's. With this approach, dentistry may continue to be one of the most trusted professions.
Alina Irina GHIRVU
Full Text Available This paper proposes a model of advertising competition based on the Cournot oligopoly model using a dynamic system, the equilibrium points of which can be determined analytically. We consider several cases for explaining the way in which firms will adapt their own advertising volume, depending on the number and the advertising volume of their competitors, in the context of an online video game used for advertising purposes. The dynamic setup is given by online Internet connection that allows interaction and communication and the high level of technology that permits nowadays real-time advertising insertions.
Full Text Available Advertising has reached new dimensions in incorporating and exploiting patterns of message transmission on certain products and services offered to the market. Therefore, advertising has become the subject of an important multidisciplinary approach, scientific analysis and research. Multiplying the cognition from different domains of human activity along with technical and scientific innovations, the advertisment has become one of the most intense communication codes which are realized in a constant interaction between an individual and the world. In order to be present in consumer's consciousness and subconsciousness, advertising simoulaneously uses our ethical, moral, mental, social communication and other cognition. The word and the language, as important media used in advertising, play an important role. The aim of this study is to analyze the linguistic code of an advertisment and language strategies of advertisers. The objective of linguistic analysis of advertisments is to confirm that the advertisment is a part of multimedial discourse which is not realized its linguistic code, but all other paralinguistic elements are present. The analysis will be carried out on a corpus consisting of advertisments published in daily newspapers from 2000-2002. The linguistic features will be analyzed as well as the relation of linguistic code with other paralinguistic codes used in advertising.
This article analyses the concept of advertising and the theoretical aspect of advertising strategy. Advertising can be defined as various means of dissemination of information on goods and services, promoting their use to potential users impersonally. Advertising strategies for selecting the location of a typical advertising plan diagram can be defined as decisions related to the target audience coverage, creative advertising message strategy selection and dissemination of the advertising st...
Donohue, Julie M; Berndt, Ernst R; Rosenthal, Meredith; Epstein, Arnold M; Frank, Richard G
We sought to examine the impact of direct-to-consumer advertising (DTCA) and pharmaceutical promotion to physicians on the likelihood that (1) an individual diagnosed with depression received antidepressant medication and that (2) antidepressant medication was used for the appropriate duration. A quasiexperimental design was used to examine treatment patterns of 30,621 depressed individuals whose insurance claims were included in the MarketScan database from 1997 through 2000. The main explanatory variables were spending on DTCA, detailing to physicians, and free samples for 6 antidepressant medications. Individuals diagnosed with depression during periods when class-level antidepressant DTCA spending was highest (cumulative spending more than US 18.5 million dollars) had 32% higher relative odds of initiating medication therapy compared with those diagnosed during periods when DTCA spending was lowest (P < 0.0001). Free samples of medications dispensed to physicians had no effect on odds of initiating antidepressant use. Class-level DTCA spending on antidepressants had a small positive effect on the duration of antidepressant use, whereas DTCA spending for the specific medication taken by an individual had no effect on treatment duration. Detailing spending at the class or product level had no significant effect on duration of treatment with an antidepressant medication. Our results suggest that DTCA of antidepressants was associated with an increase in the number of people diagnosed with depression who initiated medication therapy. DTCA was associated with a small increase in the number of individuals treated with antidepressants who received the appropriate duration of therapy. Promotion to physicians was not associated with either the initiation of treatment with an antidepressant or with the duration of therapy.
Jul 26, 2012 ... market about a new product, advertising persuades and reminds the audience ... The relevance of this topic can also be shown by the true story of the Gerber ... product was the product; people thought they were being.
Quercia, Daniele; Di Lorenzo, Giusy; Calabrese, Francesco; Ratti, Carlo
Television and newspapers sit at the top of many agency marketing plans, while outdoor advertising stays at the bottom. The reason for this is that it’s difficult to account for who views a billboard, so there is no way of consistently determining the effectiveness of outdoor advertising. As a result, agencies do not consider the medium and allocate their money elsewhere. To change this situation, one needs to create new credible audience measurements for the outdoor marketing industry. He...
Full Text Available Advertising is often critiqued for not respecting rules of ethics both in the process of advertisement design and in the way it influences society. The main concern of advertisers as representatives of companies that seek profit making is to increase sales, win new clients, increase the demand for the product they want to be presented in as nice and colorful advertisement as possible. They pretend that their product is the best, has unique qualities, better than their competitor´s, it has a better cost and brings much more benefits. That is the reason why the great challenge in advertising is to create sales efficient and at the same time moral and true advertising messages.
This communication reports the latest trends of advertising on social media. Social media advertising means to gain traffic or attention of online users through social media sites. Today, when a user thinks about buying something, he first comes to the internet, searches for that product, compares its price with other competing brands and takes a decision, which one to buy. In this write-up, author has discussed many aspects concerning advertising through social media, viz., what is social me...
This work is devoted to the Russian language advertising, which examines in an independent system. It aims are analyzing the text of Russian advertising in terms of its information and formal structure. It focuses on a specific aesthetic qualities of language, which the text uses. Work is further focused on the categorization of neologisms and neologisation of the Russian advertising. Next focus is on loanwords from the English language. Used research methods are descriptive and comparative. ...
This thesis examines advertisement in fashion blogs. The theoretical part of the research discusses blogs and the social media in general, analyzes the decision-making process of the fashion consumer, along with general consumer behavior, and then examines ethical issues and the various advertising and marketing tools used in blogs. The objective of this thesis is to ascertain how blog readers are reacting to the growing amount of advertisement currently present in fashion blogs and the ...
Andrea Galeotti; Jose Luis Moraga
textabstractWe present a strategic game of pricing and targeted-advertising. Firms can simultaneously target price advertisements to different groups of customers, or to the entire market. Pure strategy equilibria do not exist and thus market segmentation cannot occur surely. Equilibria exhibit random advertising --to induce an unequal distribution of information in the market-- and random pricing --to obtain profits from badly informed buyers--. We characterize a positive profits equilibrium...
A consistent advertising budget does not guarantee a successful advertising campaign. Two companies can spend the same amount of work and get results that completely different. Research demonstrates that creative messages may have greater importance for the success of advertising campaigns than money spent. No matter how big the budget, this activity can be successful only if the ads attract attention and effectively communicate messages.
Francisca Hanna , Febrianti
Advertising campaign merupakan serangkaian bentuk iklan melalui berbagai media dan berpusat pada satu tema dalam satu waktu. Tujuan utama advertising campaign adalah menyampaikan pesan dalam suatu tema yang diluncurkan kepada masyarakat sehingga tema tersebut menjadi ciri khas produk. Peluncuran tema campaign oleh Coca Cola dan Pepsi yang merupakan rival dalam kategori beverage merupakan obyek dari penelitian ini. Kesuksesan sebuah tema advertising campaign dilihat dengan menggunakan paramet...
This dissertation covers two areas of research that expand our knowledge on children’s advertising literacy (i.e., advertising-related knowledge). The first part addresses the development of children’s advertising literacy into adult-like levels. The second part focuses on the role of advertising literacy in reducing children’s susceptibility to advertising effects. In doing so, this dissertation not only deepens the existing theoretical and empirical insights on children’s advertising litera...
A. A. Sogorin
The basic directions of advertising studying as part of the research subject of separate social and humanitarian sciences. The definition of advertising is given. It’s considered as a holistic socioeconomic phenomenon, which consists of three basic components: advertising as a product, the final incarnation in the material and ideal forms of the customer’s ideas; advertising as an activity that is advertising as a profession; advertising as an integral part of the social space of the individ...
Cetin, Uzay; Bingol, Haluk O.
In the new digital age, information is available in large quantities. Since information consumes primarily the attention of its recipients, the scarcity of attention is becoming the main limiting factor. In this study, we investigate the impact of advertisement pressure on a cultural market where consumers have a limited attention capacity. A model of competition for attention is developed and investigated analytically and by simulation. Advertisement is found to be much more effective when the attention capacity of agents is extremely scarce. We have observed that the market share of the advertised item improves if dummy items are introduced to the market while the strength of the advertisement is kept constant.
Adina Claudia NEAMŢU
Full Text Available Campaign and especially advertising campaign represents one of the variables of the marketing mix, an important one, being difficult to separate its contribution from the one of the other elements. Irrespective of the specific object that is behind an advertising company, the investment will be retrieved only if the right information is transmitted to the right persons in the right way. This is difficult to accomplish if the advertising responsible in that firm do not understand appropriately: the market nature; the product nature; the distribution channels nature; the communication channels nature – available advertising supports and their features
This paper studies the effect of a change in the marginal costs of advertising on advertising expenditures of firms and consumer prices across industries. It makes use of a unique policy change that caused a decrease of the taxation on advertising expenditures in parts of Austria and a simultaneous increase in other parts. Advertising expenditures move immediately in the opposite direction to the marginal costs of advertising. Simultaneously the price reaction to advertising is negative in so...
Ulrich Doraszelski; Sarit Markovich
Can advertising lead to a sustainable competitive advantage? To answer this question, we propose a dynamic model of advertising competition where firms repeatedly advertise, compete in the product market, and make entry as well as exit decisions. Within this dynamic framework, we study two different models of advertising: In the first model, advertising influences the goodwill consumers extend towards a firm ("goodwill advertising"), whereas in the second model it influences the share of cons...
Duygu Aydın; Aşina Gülerarslan; Süleyman Karaçor; Tarık Doğan
Sharing motivations of viral advertisements by consumers and the impacts of these advertisements on the perceptions for brand will be questioned in this study. Three fundamental questions are answered in the study. These are advertisement watching and sharing motivations of individuals, criteria of liking viral advertisement and the impact of individual attitudes for viral advertisement on brand perception respectively. This study will be carried out via a viral advertise...
I compare the outcome when firms semicollude on advertising to the outcome in the Grossman and Shapiro (1984) model of informative advertising. I show that advertising is lower but prices and profits are higher under semicollusion on advertising. I also show that semicollusion on advertising is detrimental to welfare. Although firms earn higher profits when colluding on advertising, fewer consumers are informed, and as a result, welfare is lower. Compared to semicollusion on price, semicollus...
The majority of the media in the United States is funded through revenues derived from the sale of advertising space. The problem that arises from this situation is fundamentally an economic one: if advertisers are paying the bills for the media, how much control over content should they have? This report offers a review of instances in which…
This paper examines print advertisements in Malaysia to determine how advertisers seek to achieve their primary goal of persuading or influencing an audience by the use of both language and visuals. It describes the main component moves and rhetorical strategies used by writers to articulate the communicative purpose of the genre and the language…
G.L. Urban (Glen); G. Liberali (Gui); E. MacDonald (Erin); R. Bordley (Robert); J. Hauser (J.)
textabstractResearchers and practitioners devote substantial effort to targeting banner advertisements to consumers, but they focus less effort on how to communicate with consumers once targeted. Morphing enables a website to learn, automatically and near optimally, which banner advertisements to
A. Galeotti; J.L. Moraga-Gonzalez (José Luis)
textabstractWe present a strategic game of pricing and targeted-advertising. Firms can simultaneously target price advertisements to different groups of customers, or to the entire market. Pure strategy equilibria do not exist and thus market segmentation cannot occur surely. Equilibria exhibit
Moorman, M.; Belch, M.A.; Belch, G.E.
Most traditional advertising effect models are based on the premise that advertising is attended to and processed consciously. However, recent neuroscientific research shows that most information is unconsciously attended to, processed, and stored in memory. The concept of unconscious processing is
Full Text Available Advertising may be examined as a particular form of rhetoric the aims of which are the same as of rhetoric, namely to affect mind, will, feelings, and to persuade. The theory of rhetoric, the main object of which is discourse not only in narrow meaning (as verbal expression of ideas (i.e. to say text, but also in broad meaning – as a communicative act between the addresser and the addressee since its interdisciplinary nature provides the right tools to explore the advertising discourse. The theory of rhetoric is successfully applied in development of advertising discourse, because it helps to foresee the communicative act between the addresser and the addressee. Advertising and rhetoric are combined by many common elements, but the same goal is the most important: both, rhetoric and advertising seek for persuasion through verbal and non-verbal measures. The paper deals with the analysis of the inventive level of advertising discourse, i.e., eristic arguments, spread of ways of proofing / persuasion. Eristic argumentation is a dominant argumentation type in advertising. This method of persuasion is a way to create truth visibility although it is just superficial. The most typical schemes of eristic argumentation used in advertising are as follows: argumentum ad vanitatem (appeal to the vanity of the addressee, argumentum ad verecundiam (appeal to the authority, argumentum baculinum (method of “whip” argument, argumentum ad novitatem (appeal to novelty. The article shows the usage of eristic arguments in Lithuanian commercial ads.
Puntoni, S.; Hooge, de I.E.; Verbeke, W.J.M.I.
Abstract Consumer embarrassment is a concern for many advertisers. Yet little is known about ad-induced embarrassment. The authors investigate when and why consumers experience embarrassment as a result of exposure to socially sensitive advertisements. The theory distinguishes between viewing
Huertas, Melby Karina Zuniga; Campomar, Marcos Cortez
The Direct-to-Consumer (DTC) advertising of medicines encourages people to ask doctors for certain medicines and treatments that require medical prescription. In order to enhance their persuasive power, advertising models recommend matching the appeals (rational and/or emotional) to the consumer's attitude (cognitive and/ or affective) towards the product. This recommendation leads to controversies in the context of DTC advertising. Emotional appeals, although frequently used, would always be inadequate in that kind of advertising. In absence of empiric evidence of the consumer's perspective, a descriptive research was undertaken with the objective of evaluating: i) the components of the attitude toward medicines; ii) attitude and behavioral intentions in response to DTC ads (one appealing to reason and the other appealing to emotion). A prescription weight loss drug was chosen for this purpose. The results revealed a predominantly cognitive attitude toward the product and an attitude and behavioral intention more favorable to the rational ad. Negative cognition about the product played an outstanding role canceling the persuasive power of emotional appeals.
This dissertation covers two areas of research that expand our knowledge on children’s advertising literacy (i.e., advertising-related knowledge). The first part addresses the development of children’s advertising literacy into adult-like levels. The second part focuses on the role of advertising
Full text: Now in its fourth year, BNFL's advertising strategy continues to evolve and build upon the communication achievements of previous years. The case study this year will reflect upon progress so far and will concentrate specifically on the 1998 campaign development. It will begin by briefly reiterating the role we believe advertising plays in the communications mix and by recapping on the theoretical framework upon which the strategy continues to be based. Last year, I presented a case study on the development of BNFL's second television advertisement and supporting media. This year, I will present opinion research data which indicates that BNFL has, indeed, begun to detach itself from the contentious debate which surrounds the nuclear industry in general. Verbatim comments from respondents demonstrate that BNFL is now being perceived more widely within the UK as a successful corporate entity. The presentation will concentrate on the decision-making and research process which led us to select the content of our third advertising campaign. One key consideration being the impact of BNR:s merger with Magnox Electric plc and how their activity was incorporated into the overall advertising strategy. Having established key image characteristics through describing BNFL's scientific achievements and, more recently, BNFL's fuel recycling capabilities, the presentation will outline why this time we have opted for a total capability' advertisement whilst endeavouring to retain the five key image criteria which are at the heart of the strategy. Specific areas covered will include our clearance of the advertisement through the UK's advertising regulatory bodies (the Broadcast Advertising Clearance Centre (BACC) and the Independent Television Commission (ITQ). This in itself will demonstrate the importance of gaining detailed substantiation and legal clearance of the advertising claims made. Finally, we will share our experiences of each production phase, not least, the
Nilssen, Tore; Sørgard, Lars
We consider a model of strategic informative advertising where the advertising is done on TV and where the TV channels' advertising prices are endogenously determined. We discuss how these prices, and the advertising firms' advertising efforts, vary with the two key parameters of the model: the degree of product differentiation in the product market and a measure of the relative sizes of the TV channels' viewer bases. We find, in particular, that the larger the size difference among the TV ch...
Goldfarb, Avi; Tucker, Catherine Elizabeth
The authors examine whether the growth of the Internet has reduced the effectiveness of government regulation of advertising. They combine nonexperimental variation in local regulation of offline alcohol advertising with data from field tests that randomized exposure to online advertising for 275 different online advertising campaigns to 61,580 people. The results show that people are 8% less likely to say that they will purchase an alcoholic beverage in states that have alcohol advertising b...
Machovec, George S.
Discusses the growth of the Internet and the attitudes of users toward advertising, provides examples of kinds of advertising used on electronic networks, and lists several companies that help advertisers use the Internet. Fifteen guidelines are suggested to help advertisers use the Internet in a reasonable and appropriate way. (Contains 11…
Moraga-González, José Luis
We present a price signalling model with informative advertising. A costly advertisement informs of the good's quality directly and therefore the seller determines the fraction of informed buyers endogenously. We show that informative advertising only occurs in pooling equilibria. For an advertising
This article is based on the relationship of media and advertising creative for the report, Through the analysis of the nature and characteristics of various advertising media, from video, print, advertising, outdoor this four aspects explain the relationship between media and advertising creative. Fully understand the media for advertising creative, make the best combination of media and advertising, make advertising creative into real productivity.
Children are particularly interesting to the media and advertising, since they are more receptive to advertisement than adults during adolescence. The problem of advertising is mainly unhealthy food, but for child’s healthy growth and development a balanced diet and physical activity are most needed. The objectives of the thesis were to explore children's magazines and to determine the frequency of food advertising, and to present the phenomenon of food advertisements through different period...
At first, marketing practitioners and academics consider standardized approaches to marketing and advertising strategies in globalization, and then some studies proved that the standardization of advertising across culture is not valid. Therefore, cross cultural advertising takes local culture into account when conveying messages in advertisements. Cross cultural understanding is very important in order to produce successful localized advertising that would reflect the cultural values and nor...
Hassan Ali Al-Ababneh
The article is devoted to the study of one of the most important concepts and marketing events which is advertising. The author studies the history of the formation of modern advertising and covers the main interpretations of the concept of advertising. The article presents the data on the chronology of the formation of the key objectives of the advertising process and the basic classification of types of advertising, its purpose and place in the marketing mix. It sets out the ...
Yuxin Chen; Yogesh V. Joshi; Jagmohan S. Raju; Z. John Zhang
In mature markets with competing firms, a common role for advertising is to shift consumer preferences towards the advertiser in a tug-of-war, with no effect on category demand. In this paper, we analyze the effect of such “combative” advertising on market power. We show that, depending on the nature of consumer response, combative advertising can reduce price competition to benefit competing firms. However, it can also lead to a procompetitive outcome where individual firms advertise to incr...
Benedetto Molinari; Francesco Turino
This paper provides new empirical evidence of quarterly U.S. aggregate advertising expenditures, showing that advertising has a well defined pattern over the Business Cycle. To understand this pattern we develop a general equilibrium model where targeted advertising increases the marginal utility of the advertised good. Advertising intensity is endogenously determined by profit maximizing firms. We embed this assumption into an otherwise standard model of business cycle with monopolistic comp...
Moriarty, Sandra Ernst
Reviews advertising typography in general interest, special interest, and trade magazines and concludes that special interest magazine ads are making the most effort to be fashionable, but also have the greatest chance of having functional problems. (FL)
Martin, Susan E; Snyder, Leslie B; Hamilton, Mark; Fleming-Milici, Fran; Slater, Michael D; Stacy, Alan; Chen, Meng-Jinn; Grube, Joel W
This article presents the proceedings of a symposium at the 2001 Research Society on Alcoholism meeting in Montreal, Canada. The symposium was organized and chaired by Joel W. Grube. The presentations and presenters were (1) Introduction and background, by Susan E. Martin; (2) The effect of alcohol ads on youth 15-26 years old, by Leslie Snyder, Mark Hamilton, Fran Fleming-Milici, and Michael D. Slater; (3) A comparison of exposure to alcohol advertising and drinking behavior in elementary versus middle school children, by Phyllis L. Ellickson and Rebecca L. Collins; (4) USC health and advertising project: assessment study on alcohol advertisement memory and exposure, by Alan Stacy; and (5) TV beer and soft drink advertising: what young people like and what effects? by Meng-Jinn Chen and Joel W. Grube.
Jessen, Iben Bredahl; Graakjær, Nicolai Jørgensgaard
Sound seems to be a neglected issue in the study of web ads. Web advertising is predominantly regarded as visual phenomena–commercial messages, as for instance banner ads that we watch, read, and eventually click on–but only rarely as something that we listen to. The present chapter presents...... an overview of the auditory dimensions in web advertising: Which kinds of sounds do we hear in web ads? What are the conditions and functions of sound in web ads? Moreover, the chapter proposes a theoretical framework in order to analyse the communicative functions of sound in web advertising. The main...... argument is that an understanding of the auditory dimensions in web advertising must include a reflection on the hypertextual settings of the web ad as well as a perspective on how users engage with web content....
Rural community college presidential job advertisements that focus on geography, politics, and culture can improve the likelihood of a good fit between the senior leader and the institution. (Contains 2 figures.)
In time when internet is becoming one of the major channels for sales and spreading information, organizations, companies and individuals face challenges on how to present their websites to wider audience as well as attract new visitors. In this thesis we have presented paid online advertising, which can be used by any website owner, even individual, to drive visitors to their websites in an easy and fast way. We have also presented main advertising channels, major global and local players, t...
This article presents strategies for advertising the medical practice. The emphasis is on breaking out of the old rules of how one should advertise and delves into asking questions that lead to a true strategy unique to one's medical practice and offerings. The article discusses the myriad ways to think about and create a patient-centered approach, turning from "here is what we offer" to instead "what you want we offer." Copyright © 2010 Elsevier Inc. All rights reserved.
Denis Kislov, Yevgenia Horobei
Goal of the paper. The goal of this article is to define the nature, specific features and factors pertaining to the advertising agency marketing management. One of the tools is the use of non-standard approaches to management of advertising agencies, which under certain conditions makes it possible to improve the situation and to bring the agency to a new higher level as well as to improve the efficiency of its functioning in the conditions of transformational economy of Ukraine. Methodol...
Rosa Branca Esteves
This article is a first look at the dynamic effects of customer poaching in homogeneous product markets, where firms need to invest in advertising to generate awareness. When a firm can recognize customers with different past purchasing histories, it may send them targeted advertiseraents with different prices. It is shown that only the firm that advertises the highest price in the first period will engage in price discrimination, and that poaching clearly benefits the discriminating firm, Th...
Lovitskii, Vladimir; McCaffery, Colin; Thrasher, Michael; Traynor, David; Wright, Peter
Mobile advertising is a rapidly growing sector providing brands and marketing agencies the opportunity to connect with consumers beyond traditional and digital media and instead communicate directly on their mobile phones. Mobile advertising will be intrinsically linked with mobile search, which has transported from the internet to the mobile and is identified as an area of potential growth. The result of mobile searching show that as a general rule such search result exceed 1...
Ramona Olivia ŞTEFĂNESCU-MIHĂILĂ
Advertising industry is more and more often associated to brilliant minds in areas such as: psychology, sociology, anthropology, who turned a job into a full time task of “penetrating the collective public mind, (...) its manipulation, exploitation and control”. That is why, ever since its beginnings, the advertising industry was admonished by social critics for taking materialism to the highest levels; to replace inner happiness and intrinsic motivation with the wish to be productive in soci...
Bogdan ANASTASIEI; Raluca CHIOSA
Emotions can transcend cultural, linguistic, demographic, and social boundaries. Emotions affect information processing and create a positive attitude toward the ad, which becomes associated with the brand. Objectives. This study investigates the role of pleasure (P), arousal (A) and domination (D) emotions in mobile’s photo camera advertisement and how each of them is influencing consumer attitude towards the advertisement and brand. Prior Work. Holbrook and Batra (1987) develope...
Full Text Available Emotions can transcend cultural, linguistic, demographic, and social boundaries. Emotions affect information processing and create a positive attitude toward the ad, which becomes associated with the brand. Objectives. This study investigates the role of pleasure (P, arousal (A and domination (D emotions in mobile’s photo camera advertisement and how each of them is influencing consumer attitude towards the advertisement and brand. Prior Work. Holbrook and Batra (1987 developed their own emotional scale based on these three dimensions (PAD, showing that these emotions mediate consumer responses to advertising. Approach. A 1*4 factorial experiment design method was adopted in order to measure the impact of independent variables (emotion type on dependent variables (attitude toward ad, attitude toward brand. Results. The results revealed that emotions like Pleasure (loving, friendly, grateful and Arousal (active, interested, excited, entertained influence consumers' attitudes towards brand and advertising. Value. Marketers need to understand the role of pleasure and arousal emotions when making advertising campaign; an effective promotion leads to persuading consumers. The results indicate that marketing practitioners should measure affective responses when testing an advertisement, as long as this action would predict brand attitude.
Full Text Available Research has revealed that much of what happens in our minds as a result of language use is still hidden from our conscious awareness. Advertisers know this phenomenon better. They use the manipulation of language to suggest something about their products without directly claiming it to be true. Although the advertisers use colours, symbols, and imagery in advertisements, “the most direct way to study ads is through an analysis of the language employed” as all the other aspects are meant to reinforce the language message. Ads are designed to have an effect on consumers while being laughed at, belittle and all but ignored. Some modern advertisements appear to be almost dissuading consumers from the product – but this is just a modern technique. This paper is going to analyze a series of language techniques used by advertisers to arrest our attention, to arouse our interest, to stimulate desire for a product and ultimately to motivate us to buy it. Once we become familiar with the language strategies used in advertising messages we will be more able to make our own buying decisions.
Tom Coupe; Olena Gnezdilova
We use panel data on advertising expenditures to check the influence of tobacco advertising bans on the advertising industry. We find no clear evidence of a negative effect of tobacco bans on total per capita advertising expenditures.
Patrice de Rendinger
Full Text Available The fundamental concept is that public space is not a private property. So, a facade (the outer skin, the last millimeter belongs to the town, not to the owner of the building. Changing the rendering, a window, adding or removing anything from a facade requires a permission delivered by the town's authority.In places like Paris, Bordeaux, Marseilles, Lyon, Strasbourg… everywhere one can find a registrated building such as a cathedral, a castle, or a group of ancient buildings, a national administration is controlling this permission. This administration is called «historical monuments administration» and is locally lead by a specialized architect.In the late seventies, French government decided to reduce advertising on the roads and on the city walls. Advertising on the road was leading to a confusion reducing the efficacy of the roadsigns and direction signs, which is dangerous. The reduction was under control of a national administration: the ministry of equipment in charge of the roads design. Advertising on the walls with publicity boards was under control of the cities. Every city has a townplanning regulation. Many cities included forbidding advertisement boards on the walls in this regulation.A couple of firms, but mainly once (Decaux found clever to give a hand to the cities to control advertising. Decaux developed a line of bus stop shelters including advertisements and advertising panels and paid the cities the right to put rather smaller publicities on the public domain.Now Decaux is no more alone on this market and the cities are comparing offers.Marseille turned to a foreign advertising firm who pays three times the price Decaux paid… for half of the advertising surface. Freiburg erased totally the public domain advertisements, selling the tramways and bus coachwork as advertising spaces. Paris is reopening the advertising market before the end of Deacaux's contract and will pay Deacaux a huge amount
Salim, Ali; Alikhani, Nima
This report has been produced as a result of a Thesis assignment conducted at Ericsson. Itspurpose is to give an overview of the Mobile Advertising industry. In this report an overviewof mobile advertising is presented and thru which channels advertising could be used. Thenthree mobile advertising campaigns are shown and described with background, strategy andresults. The different global markets, the different actors in the value chain and how the onlinebehavior has changed are analyzed. The...
James D. Griffith
Full Text Available Female escorts represent an occupational group that charges a fee for sex, which can be regarded as an extreme form of short-term mating. The present study examined if the fees charged by escorts are related to traits typically associated with female short-term mate value. A total of 2,925 advertisements for female escorts offering sexual services in the United States were examined, as a customized software program was used to download all the advertisements from an online escort directory. The advertisement content was coded, and relationships between advertised physical characteristics and the hourly rate charged by female escorts were examined. The analyses showed that higher fees were associated with female escorts who advertised a waist-to-hip ratio near 0.7, lower weight and body mass index, younger age, and photographic displays of breast and buttocks nudity. The findings provide evidence that evolutionarily relevant traits associated with female short-term mate value are systematically related to fees charged for sexual services.
This thesis was written in order to develop advertising for the manor hotel Karolineburg, located in Kajaani, Finland, by using a social network as advertising media. This work also had for goal to show the possibility of social advertising and the benefits it can bring along. According to the situation of the company, findings and results revealed positive aspects of the work done.
Rozendaal, E.; Lapierre, M.A.; van Reijmersdal, E.A.; Buijzen, M.
It is widely assumed that advertising literacy makes children less susceptible to advertising effects. However, empirical research does not provide convincing evidence for this view. In this article, we explain why advertising literacy as it is currently defined (i.e., conceptual knowledge of
NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA MBA PROFESSIONAL REPORT NAVY ADVERTISING : TARGETING GENERATION Z December......study recommends improvements for Navy advertising efficiency by examining characteristics of recruits defined as Generation Z. Data gathered from five
@@ Definition of Advertising English Advertising is the nonpersonal communication of information usually paid for and usually persuasive in nature about products, service or ideas by identi- fied sponsors though various media (丁静, 2005:138 ).
Bagherjeiran, Abraham; Bhatt, Rushi P.; Parekh, Rajesh; Chaoji, Vineet
Online social networks offer opportunities to analyze user behavior and social connectivity and leverage resulting insights for effective online advertising. This chapter focuses on the role of social network information in online display advertising.
Full Text Available Many times, we have had a chance to hear that marketing communications are something that can move ahead of time. However, there are many areas in which they are moving slowly than time, without consideration of provided conditions. One of these areas is gender portraying, that is, accepted roles of women and men in the society. We cannot deny that gentle movements have been made towards their more realistic presentation, but a persistent claim that results from recent researches is that marketing communications and particularly advertising, as instrument that most directly reflects this theme, has remained rather resistant to changes in the society. Consequently values that have been built in brands with help of advertising are rather obsolete. Differently speaking, advertising has a showdown with stereotyping - as an assignment of a (usually negative label to certain groups of people based on a certain belief about how these people tend to behave in the society.