Ethical DTC Advertising

Journal of Health Politics, Policy and Law Advance Publication, published on February 15, 2013
Prescription Drugs and Administrative Costs
The Politics and Strategy of Industry Self- Regulation: The Pharmaceutical Industrys Principles for Ethical Direct-to-Consumer Advertising as a Deceptive Blocking Strategy
Denis G. Arnold University of North Carolina, Charlotte James L. Oakley Montana State University
Abstract As the pharmaceutical industry lobbies European regulators to permit
direct- to- consumer advertising (DTCA) of prescription drugs in the European Union, developed and - promulgated we found that five leading companies violated industry- 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 industrys 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.
Companies in the health care industry enhance or harm the well- being of nearly all citizens in industrialized nations. Regulators confront trade- offs between inhibiting corporate efficiency and protecting patient well- being in determining health care regulation. Self- regulation is one potenThe authors gratefully acknowledge financial support for this project provided by the Jule and Marguerite Surtman Foundation and the Belk College of Business, University of North Carolina at Charlotte. The authors would like to thank the University of North Carolina at Chapel Hill for providing access to the TNS Media Ad$pender Database, and we thank AC Nielsen for provision of the Nielsen Monitor- Plus data. The authors would also like to thank Jennifer Burnham, Rebecca Glavin, Marta Gomez- Jordana Ariz, and William Brandon for research assistance. Thanks also to editor Colleen Grogan and two anonymous reviewers for their constructive feedback in the review process. Journal of Health Politics, Policy and Law, Vol. 38, No. 3, June 2013 DOI 10.1215/03616878-2079496 2013 by Duke University Press
Copyright 2013 by Duke University Press
506 Journal of Health Politics, Policy and Law
tial industry strategy for protecting patient well- being while minimizing the inefficiencies that can arise with the introduction of new regulations. Industry self- regulation proponents point to its potential effectiveness and efficiency (LaBarbera 1983; Rotfeld, Abernethy, and Parsons 1990). Critics of industry self- regulation point out that it may be used as a duplicitous means of placating stakeholders without substantively altering behavior (Brownell and Warner 2009). In this article we empirically assess pharmaceutical industry compliance with one self- regulatory scheme. We utilize this research to provide a novel theoretical account of firms public affairs strategies and to provide insight into pharmaceutical industry behavior for policy makers and other interest groups in the United States, New Zealand, the European Union, and elsewhere.
Direct-to-Consumer Advertising
In 1997 the US Food and Drug Administration (FDA) relaxed its policy to- on pharmaceutical marketing efforts, effectively permitting direct- consumer prescription pharmaceutical advertising via television commercials (Pines 1999). Presently, direct- to- consumer advertising (DTCA) of prescription pharmaceuticals is permitted only in the United States and New Zealand. However, European leaders have been confronted by repeated waves of pharmaceutical industry lobbying to allow the 500 million residents of the European Union to be targeted by DTCA (Geyer 2011). Total pharmaceutical industry spending on direct- to- consumer television and print advertising in the United States has risen from $985 million in 1996 to a high of $4.8 billion in 2007 before settling back to an estimated $4.4 billion in 2008, $4.7 billion in 2009, and $4.3 billion in 2010 (table 1). The pharmaceutical industry and other supporters have consistently argued that DCTA is an effective way to educate consumers about diseases and appropriate treatments in the interest of patient welfare (Calfee 2002; Holmer 1999, 2002; PhRMA 2004, 2008). On the other hand, since the practice began, direct- to- consumer television advertising has been criticized for providing poor- quality information and for undermining physician- patient relationships (Hollon 1999; Lexchin and Mintzes 2002; Wolfe 2002). In recent years criticism of direct- to- consumer television advertising has become more widespread and acute. This type of advertising has been criticized for failing to provide consumers with adequate information on the health risks and benefits of pharmaceuticals (Friedman and Gould 2007; Kaphingst and DeJong 2004), for encouraging overmedi-
Arnold and Oakley n Politics and Strategy of Industry Self- Regulation 507
Table 1 Direct- to- Consumer Media Spending for Prescription Pharmaceuticals (in millions of dollars) Year DTC Spending
1996 $985 1997 $1,301 1998 $1,578 1999 $2,166 2000 $2,798 2001 $2,954 2002 $2,864 2003 $3,478 2004 $4,160 2005 $4,237 2006 $4,741 2007 $4,838 2008 $4,416 2009 $4,716 2010 $4,328
Source: TNS/Kantar Media Intelligence Ad$pender
cation rather than lifestyle changes to promote health (Woloshin et al. 2001; Vogt 2005; Frosch et al. 2007), for increasing medicalization in the United States where previously nonmedical problems are identified and treated as medical issues (Conrad and Leiter 2004), for altering the countervailing powers in the marketplace to one where pharmaceutical manufacturers and marketers have greater influence relative to medical providers (Hartley and Coleman 2007), and for manipulating consumers by using low cognitive elaboration persuasive techniques rather than engaging in genuine education (Arnold 2009; Royne and Myers 2008). It has also been argued that DCTA unnecessarily drives up health care spending by increasing the cost of medication to cover large marketing budgets (Abramson 2004; Avorn 2004; Dave and Saffer 2010; Law et al. 2009) and by increasing demand for brand- name drugs that do not perform better than generic alternatives or nonpharmacological therapies (Angell 2004). In addition, as popular prescription drugs find their way into black markets or other unregulated channels of distribution, prevalent DTCA may inadvertently encourage nonprescription or illegal drug acquisition and consumption (Myers, Royne, and Deitz 2011). Considerations such as these have prompted discussion of greater restrictions for direct- to- consumer broadcast advertising (Shuchman 2007). Partly in response
to such criticism, the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group based in Washington, DC, announced in 2005 that it would self- regulate pharmaceutical television advertising to facilitate health care education via its PhRMA Guiding Principles and a reporting mechanism for violations (Saul 2005). Many pharmaceutical companies have certified that they are in compliance with these guidelines. Since industry self- regulation may be regarded as a substitute for governmental regulation of DCTA (Davies, Steinberg, and Goldfarb 2005), it is important to know whether individual pharmaceutical company practices are actually in compliance with the guiding principles. If pharmaceutical companies are not adhering to principles that they themselves developed and promulgated in conjunction with PhRMA, then governmental regulation may turn out to be a more suitable response to criticisms of pharmaceutical advertising than industry self- policing.
Organizational Theory and Self- Regulation
When addressing self- regulation, health policy scholars have typically focused on the medical professions (Arrow 1963; Havinghurst 1995; Hammer et al. 2003) or federally mandated self- regulatory schemes composed of physicians and intended to ensure that government funds are being spent wisely, such as the US Professional Standards Review program (Stone 1977). However, little attention has been paid to health care industry self- regulation. Our study of pharmaceutical industry self- regulation draws on three areas of organization theory and business ethics research to provide a theoretical framework for our analysis: public affairs regulation. strategies, executive commitment, and self- Corporate public affairs strategies have previously been characterized by Fennel and Alexander (1987) and Meznar and Nigh (1995) as falling into two categories: buffering and bridging. Organizations buffer themselves against external pressures by augmenting internal structures or resources to better cope with external constraints; by engaging in political activity such as lobbying, political contributions, and advocacy advertising; or by creating or enhancing peripheral structures, such as industry trade groups, to interface with the sources of environmental pressures (Meznar and Nigh 1995). Through buffering, organizations resist or attempt to control external pressures. An alternative strategy is bridging, in which firms take the proactive internal measures necessary to meet external expectations. As noted by Meznar and Nigh (1995), this might
be accomplished by meeting and exceeding regulatory requirements or by voluntarily implementing self- regulatory standards within an industry. Consistent with a bridging strategy, PhRMA member companies pledged to adhere to fifteen guiding principles for direct- to- consumer advertising, effective January 1, 2006 (PhRMA 2005). In addition, PhRMA created an Office of Accountability to receive and process public comments about company compliance with the principles. In December 2008 PhRMA revised and expanded these principles, and the new set of eighteen principles became effective March 2, 2009 (see table 2 for original and revised principles). The revised principles require com panies to certify that they are in compliance with the guiding principles. This is accomplished when a company commits to internal processes to ensure compliance with the principles, completes an annual certification of compliance with the principles, and submits a document to PhRMA signed by the chief executive and the chief compliance officer attesting to compliance with the principles (PhRMA 2008, n.d.). Top management commitment to an ethics program has been shown to have significant influence over formal control systems that standardize the behavior of employees within an organization and facilitate compliance with ethics codes and standards (Weaver, Trevio, and Cochran 1999). When top management is committed to a set of values or principles, organizational practices are more likely to be aligned with those practices than when top management is not committed to the values or principles. Assuming that competent management teams are in place, theory predicts that in a case in which top management has publicly committed to adhering to specific values or principles and certified that internal compliance measures have been incorporated into organizational management, a firm will adhere to the corresponding values or principles. Since the PhRMA Guiding Principles require that the chief compliance officers and chief executive officers formally affirm that the principles are being followed and that control structures are in place within their companies, existing theory predicts that signatory companies are in compliance with the principles via a bridging strategy. However, previous research on industry self- regulation has found that its primary purpose is to reduce reputational risk and potential sanctions by engaging in outreach and communication to stakeholders rather than to serve as a means of substantially improving the ethical behavior of companies (King and Lenox 2000; Nash, Howard, and Ehrenfeld 2000). Without external oversight and explicit sanctions for violating self- regulatory norms, such as expulsion from the trade group, compliance has
Table 2 PhRMA DTC Guiding Principles
Risks vs. Benefits
Empirically Original Guidelines Revised Guidelines Shorthand Assessable
2 10 Identical (4)
In accordance with FDA regulations, all DTC information Identical + Accordingly, companies should Accuracy Y should be accurate and not misleading, should make continue to base promotional claims on and claims only when supported by substantial evidence, FDA approved labeling and not promote Balance should reflect balance between risks and benefits, and medicines for off- label uses, including in should be consistent with FDA approved labeling. (2) DTC advertisements. (2) DTC television advertising that identifies a product by Identical (13) Conditions Y name should clearly state the health conditions for which and Risks the medicine is approved and the major risks associated with the medicine being advertised. (10) Prescription Labeling and Nonprescription Treatment Options Prescription Y
4 9 Identical (12)
DTC television and print advertising of prescription drugs should clearly indicate that the medicine is a prescription drug to distinguish such advertising from other advertising for nonprescription products. (4) DTC television and print advertising should include info mation about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition. (9)
Alternatives
Table 2 (continued )
Promotion of Health and Disease Awareness Disease Awareness Uninsured Y Y
14 15
Companies are encouraged to promote health and disease Identical (17) awareness as part of their DTC advertising. (14) Companies are encouraged to include information in all Identical (18) DTC advertising, where feasible, about help for the uninsured and underinsured. (15) Educational Value
Educate
3 DTC television and print advertising which is designed Identical + During the development of new to market a prescription drug should also be designed to DTC television advertising campaigns, responsibly educate the consumer about that medicine and, companies should seek and consider feedback where appropriate, the condition for which it may be from appropriate audiences, such as health prescribed. (3) care professionals and patients, to gauge the educational impact for patients and consumers. (3) 11 DTC television and print advertising should be designed to DTC television and print advertising should achieve a balanced presentation of both the benefits and the be designed to achieve a balanced presentation risks associated with the advertised prescription medicine. of both the benefits and the risks associated Specifically, risks and safety information in DTC television with the advertised prescription medicine. advertising should be presented in clear, understandable Specifically, risks and safety information, language, without distraction from the content, and in a including the substance of relevant boxed manner that supports the responsible dialogue between warnings, should be presented with reasonably patients and health care professionals. (11) comparable prominence to the benefit
Clear and Understandable
(continued)
Table 2 PhRMA DTC Guiding Principles (continued )
information, in a clear, conspicuous and neutral manner, and without distraction from the content. In addition, DTC television advertisements should support responsible patient education by directing patients to health care professionals as well as to print advertisements and/or websites where additional benefit and risk information is available. (14) Age-Appropriate Audience
13 In terms of content and placement, DTC television and print In terms of content and placement, DTC Audience advertisements should be targeted to avoid audiences that are television and print advertisements should be Composition not age appropriate for the messages involved. (13) targeted to avoid audiences that are not age appropriate for the messages involved. In Advertisements containing content that may be inappropriate particular, DTC television and print advertise for children should be targeted to programs or publications ments containing content that may be inap that are reasonably expected to draw an audience of approxi- propriate for children should be placed in mately 80 percent adults (18 years or older). Companies will programs or publications that are reasonably be individually responsible for examining reliable, up- to- date expected to draw an audience of approxi audience composition data, to the extent that information is mately 90 percent adults (18 years or older). available, to determine whether a particular program or publi- (16) cation is reasonably likely to attract an audience that is age appropriate for a particular advertisement.
Unable to Assess Empirically Preamble N
Responsible Communication
Y*
1 These Principles are premised on the recognition that DTC Identical (1) advertising of prescription medicines can benefit the public health by increasing awareness about diseases, educating patients about treatment options, motivating patients to con tact their physicians and engage in a dialogue about health concerns, increasing the likelihood that patients will receive appropriate care for conditions that are frequently under- diagnosed and under- treated, and encouraging compliance with prescription drug treatment regimens. (1) 5 DTC television and print advertising should foster responsible Identical (5) communications between patients and health care professionals to help patients achieve better health and a more complete appreciation of both the health benefits and the known risks associated with the medicine being advertised. (5) 6 In order to foster responsible communication between patients Identical (6) and health care professionals, companies should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign. In deter mining what constitutes an appropriate time, companies should take into account the relative importance of informing
Detailing
(continued)
Table 2 PhRMA DTC Guiding Principles (continued )
Safety Risk
FDA Submission Serious MedWatch
Y** Y***
patients of the availability of a new medicine, the complexity of the risk- benefit profile of that new medicine and health care professionals knowledge of the condition being treated. Companies should continue to educate health care profes sionals as additional valid information about a new medicine is obtained from all reliable sources. (6) 7 Working with the FDA, companies should continue to Identical (7) responsibly alter or discontinue a DTC advertising campaign should new and reliable information indicate a serious pre viously unknown safety risk. (7) 8 Companies should submit all new DTC television advertise- Identical (8) ments to the FDA before releasing these advertisements for broadcast. (8) 12 All DTC advertising should respect the seriousness of the Identical (15) health conditions and the medicine being advertised. (12) DTC print advertisements for prescription medicines should include FDAs toll- free MedWatch telephone number and website for reporting potential adverse events. DTC tele vision advertisements for prescription medi cines should direct patients to a print adver tisement containing FDAs toll- free MedWatch telephone number and website, and/or should provide the companys toll- free telephone number. (9)
L1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
Y*** Companies that choose to feature actors in the Actors roles of health care professionals in a DTC television or print advertisement that identifies a particular product should acknowledge in the advertisement that actors are being used. Likewise, if actual health care professionals appear in such advertisements, the advertisement should include an acknowledgement if the health care professional is compensated for the appearance. (10) Where a DTC television or print advertisement Endorsers features a celebrity endorser, the endorsements should accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies should maintain verification of the basis of any actual or implied endorsements made by the celebrity endorser in the DTC advertisement, including whether the endorser is or has been a user of the product if applicable. (11) N***
* Principle 5 is likely assessable empirically, but doing so is beyond the scope of the present study. ** Principle 12 is a subjective judgment that we did not assess, although in theory compliance might be assessed. *** In the revised guiding principles (PhRMA 2008), principles 9, 10, and 11 are likely to be empirically assessable. However, these principles were not introduced until March 2, 2009, and the bulk of the content data contained in the present study does not allow for the assessment of compliance with these three new principles.
been found to be unreliable, even in the presence of powerful peer organizations and self- regulatory institutions (King and Lenox 2000). The legal environment strongly influences the prospect that organizations will carry out the self- regulatory commitments. That is, without legally enforceable sanctions for failures in compliance, self- regulatory systems are unlikely to be effective, especially with organizations that have a history of poor compliance with previous regulations (Short and Toffel 2010). Abraham (2009) argues that the market power and political influence of pharmaceutical organizations effectively limit or delay new national policies regulating the pharmaceutical industry. Since no formal sanctions for violations of the guiding principles exist, theory predicts poor compliance. Given the conflicting theoretical predictions of company behavior that emerge from studies of firms public affairs strategies, executive commitment, and self- regulation, further investigation is warranted.
Methods
We build a new theoretical account of self- regulatory public affairs strategies by analyzing the case of compliance with the guiding principles by five pharmaceutical firms. This inductive method of analysis is particularly appropriate for developing novel theory in light of conflicting or paradoxical evidence (Eisenhardt 1989).
Sample Selection
We obtained copies of the original and revised guiding principles from the PhRMA Office of Accountability website. The original fifteen guiding principles were announced on August 2, 2005 (Saul 2005), and in effect from January 1, 2006, to March 1, 2009. The revised guiding principles, which include three additional principles, went into effect on March 2, 2009, and remain in effect as of this writing (table 2 has been provided to facilitate the tracking of individual principles). To select companies to study, we first settled on a class of pharmaceuticals based on the following criteria. First, the pharmaceuticals in the class were approved by the FDA for use in the United States prior to January 1, 2006. Second, pharmaceuticals in that class were heavily advertised on television and in print during the study period (January 1, 2006 December 31, 2009). It must be noted that DTCA is utilized for only a small number of prescription drugs, with most prescription drugs not receiving any DTCA efforts (Capella et al. 2009). Third, all the guiding principles applied to
Table 3 Direct- to- Consumer Media Spending for Erectile Dysfunction Drugs, and Total Ad Spending and Television Spending for the Three ED Brands (in millions of dollars) ED Category Viagra Cialis Levitra
Year Total TV Total TV Total TV Total TV 2006 2007 2008 2009 2010 $200.3 $130.2 $101.2 $34.8 $44.3 $43.1 $54.8 $52.3 $237.2 $210.7 $64.5 $43.4 $126.4 $124.9 $46.3 $42.4 $313.8 $279.1 $121.1 $89.2 $144.1 $143.0 $48.6 $46.9 $337.6 $267.8 $128.0 $92.9 $174.7 $141.7 $34.9 $33.2 $324.3 $230.0 $101.7 $62.1 $217.2 $167.9 $5.4 $0.0
Source: TNS/Kantar Media Intelligence Ad$pender
pharmaceuticals in the class. Because principle 13 (audience composition) from the original guiding principles applies only to pharmaceuticals for which there is an audience that is age appropriate for the messages involved, we focused on pharmaceuticals whose advertisements had content inappropriate for children. Such content includes programming that promotes alcohol consumption, smoking, and sexual activity and does not warn of the risks of pregnancy or sexually transmitted diseases (American Academy of Pediatrics Committee on Communication 2006; Strasburger 2004). A commonly marketed class of pharmaceuticals that meets these criteria is for the treatment of erectile dysfunction. Each of the three erectile dysfunction pharmaceuticals currently on the market was approved by the FDA prior to 2006 and was heavily advertised utilizing direct- to- consumer channels throughout the entire period of our study (see table 3 for details on DTCA spending for the three erectile dysfunction drugs). Furthermore, according to the American Academy of Pediatrics, Ads for ED drugs give children and teens inappropriate messages about sex and sexuality at a time when they are not being taught well in school sex education programs (American Academy of Pediatrics Committee on Communication 2006). For this reason, erectile dysfunction pharmaceuticals fall under the scope of principle 13 and have an age- appropriate audience. Other drugs considered for analysis were birth control pills and drugs for treating sexually transmitted diseases such as herpes and human papillomavirus. During the period under study (January 1, 2006 December 31, 2009), advertisements for the Bayer birth control medication Yaz (drospirenone/ethinyl estradiol) were deemed misleading by the FDA in a warning letter, and the company was ordered to disseminate truth-
ful, non- m isleading, and complete corrective messages (US Food and Drug Administration 2008: 6), resulting in the dissemination of corrective advertisements and other altered marketing efforts for this drug and the entire category. As for drugs designed to treat or prevent STDs, we were unable to identify a category of drugs heavily advertised by multiple manufacturers during the period under study. Drugs intended for the treatment of erectile dysfunction, however, are heavily advertised to consumers, and the category contains three competitive brands that have been utilizing DTCA channels throughout the entire period of our study. This class of pharmaceuticals consists of phosphodiesterase inhibitors intended for the treatment of impotence or erectile dysfunction. These include sildenafil citrate, manufactured and marketed as Viagra in the United States by Pfizer; tadalafil, manufactured and marketed as Cialis in the United States by Eli Lilly; and vardenafil, manufactured by Bayer Healthcare and jointly marketed as Levitra in the United States by Bayer Healthcare, GlaxoSmithKline, and Schering Plough/Merck (Schering- Plough merged with Merck on November 3, 2009). We consulted the PhRMA Office of Accountability website to verify that Pfizer, Eli Lilly, Bayer Healthcare, GlaxoSmithKline, Schering Plough, and Merck were signatory companies and that each company certified its compliance with the guiding principles (PhRMA 2009). To assess company compliance with the original and revised guiding principles, we selected principles for which publicly available information suitable for determining compliance could be acquired and undertook multidimensional data collection and analysis (see table 2 for details on which of the guiding principles are empirically assessable). The selection of pharmaceutical consumer advertisements for erectile dysfunction is also significant because the three drugs are marketed by five of the largest global pharmaceutical companies as measured by revenues (Fortune 2009 ; see table 3 for details on the marketing expenditures of the organizations under study). An understanding of the spending levels of the brands under study provides useful context for assessing DTCA and compliance with the guiding principles. While total industry spending on direct- to- consumer media has declined slightly since 2007, annual spending on direct- to- consumer erectile dysfunction media during the period in which the PhRMA guidelines have been in effect has increased to $324.3 million in 2010 from $200.3 million in 2006 (table 3). In addition, Pfizer (maker of Viagra) has increased its overall DTCA spending from $960.1 million in 2006 to $1.25 billion in 2010, and Eli Lilly (maker of Cialis) has doubled its
spending since the introduction of the PhRMA guidelines, from $230 million in 2006 to $478.3 million in 2010. To assess whether an organization is in full compliance with guidelines that it has formally pledged to adhere to would require that researchers evaluate compliance with each principle. However, to establish a pattern of noncompliance with guidelines by an organization, it is sufficient to assess compliance with a subset of the principles. If consistent and significant violations by an organization are found, a pattern of noncompliance will be established for that organization. Determining whether a pattern of noncompliance with the guiding principles by these companies exists will provide one way to assess industrywide practices.
Selection of Principles
The present study investigates the original guiding principles that allowed for independent verification of compliance. Principle 1 is a prefatory statement about the public health value of direct- to- consumer advertisements and does not require specific actions, so assessing compliance is not feasible. Of the fourteen remaining principles, nine allowed for independent verification of compliance through the methods described below. For this study we were able to independently assess compliance with principles2, 3, 4, 9, 10, 11, 13, 14, and 15 (see table 2). Information about our inability to assess the remaining five principles is provided here. Principle 5 (Responsible Communication) states that DTCA should encourage communication between patients and doctors to achieve better health and an appreciation of both the benefits and risks associated with the medicine being advertised. Assessing compliance with this principle would entail in- depth interviews and surveys with target consumers and health practitioners, which, while practicable, is beyond the scope of the present research. In addition, there has already been empirical research doctor relationships (Datti and on the effect of DTCA on consumer- Carter 2006; Mintzes et al. 2003; Weissman et al. 2003, 2004). Principle 6 (detailing) requires that companies spend an appropriate amount of time educating health professionals about new medicines before beginning DTCA. To assess compliance, researchers would need to independently track direct- to- physician marketing by companies at the time the companies introduce new drugs, a task that would require substantial resources and company cooperation. Both for this reason and because DTCA for all three erectile dysfunction drugs had commenced at the time
of our study, there was no way to assess compliance with this principle. Principle 7 (safety risk) requires companies to voluntarily alter or discontinue advertisements when serious safety risks are discovered. This is an existing statutory requirement, Code of Federal Regulations 2006 21 CFR 314.70(a)(4), overseen by the FDAs Office of Prescription Drug Promotion (OPDP) (formerly Division of Drug Marketing, Advertising, and Communications), rather than a strictly voluntary principle of conduct. Because OPDP works with companies to facilitate compliance but does not track and report whether companies initiate the changes or do so only in response to FDA directives, it is not possible to assess compliance with this principle (personal communication, US Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, July 28, 2010). Principle 8 (FDA submission) requires companies to submit all new direct- to- consumer advertisements to the FDA prior to broadcasting the advertisements. The FDA reports that it does not have the resources to track whether companies submit advertisements prior to initial broadcast (personal communication, Administration, Division of Drug Marketing, Advertising, and Communications, July 22, 2010). Because data are not available to assess compliance with principle 8, we did not attempt to assess compliance with this principle. Principle 12 (serious) requires that advertisements respect the seriousness of the health conditions and the medicine being advertised. This is a subjective judgment that we did not evaluate, although in theory compliance might be assessed.
Data Collection
To determine spending on DTCA for erectile dysfunction medications we consulted the TNS Media Intelligence Ad$pender database (tables 1, 3). The Ad$pender database contains data obtained through the tracking of local and national advertising campaigns covering television, print, radio, and online advertising (see also Donohue, Cevasco, and Rosenthal 2007). To evaluate erectile dysfunction television advertising compliance with PhRMA Guiding Principles requiring specific content (principles 2, 3, 4, 9, 10, 14, and 15), we purchased all available product advertisements (Kolsarici and Vakratsas 2010) for Viagra, Cialis, and Levitra that aired in the United States between January 1, 2006, and December 31, 2009, from USA TV Ads, which records national television advertising via satellite and cable television. Time- stamped audio and video transcripts were produced for each of the twenty- four, sixty- second commer-
cials recorded: seven for Viagra, twelve for Cialis, and five for Levitra. Each of the twenty- four commercials referred reviewers to a magazine print advertisement, website, or phone number for more detailed patient information. We obtained samples of fifteen Viagra, ten Cialis, and three Levitra print advertisements from issues of magazines published during the period of study. Some of the advertisements in this sample contained the same text, thus leaving ten unique Viagra examples, five unique Cialis examples, and two unique Levitra examples for analysis. We also obtained patient information from company websites and by mail in response to telephone requests. To evaluate compliance with PhRMA principle 13, about age appropriateness of the viewing audience, Nielsen Monitor- Plus data were purchased from AC Nielsen for the four complete calendar years, 2006 through 2009. The Nielsen Monitor- Plus dataset reports gross rating points for National Cable, Broadcast, and Syndication occurrences of all television advertisements. Specifically, the report identified all occurrences of Viagra, Cialis, and Levitra television spots, along with audience composition as measured by Nielsen.
Data Analysis
Principle 2 (accuracy and balance) requires a balanced presentation of risks and benefits. According to FDA guidelines, balanced presentation should include an even distribution of time devoted to risks and benefits (US Food and Drug Administration 2009). To evaluate compliance with these principles, we conducted dual- rater content analysis of the entire audio transcripts of all twenty- four television advertisements aired during the four- year period. Since the coding was based on a continuous measure (i.e., the amount of time per commercial airing), inter- rater reliability was assessed using the intraclass correlation coefficient resulting in a 92 percent coefficient of reliability (Kassarjian 1977). Coding disagreements between the researchers were minor and thus were resolved by consensus. To evaluate principle 4 (prescription), which requires a clear indication that the medication requires a prescription, principle 9 (alternatives), which requires the provision of information about options other than medication for treatment of the condition, principle 10 (conditions and risks), which requires a clear statement of the condition for which the medication is approved and the health risks associated with the medicine, principle 14 (disease awareness), which encourages companies to promote health and disease awareness in their advertisements, and principle 15 (unin-
sured), which encourages companies to provide information about help for the uninsured and underinsured in their advertisements, we utilized literal textual analysis. As other researchers have argued, not all analysis of text requires formal content analysis to produce significant data (Harwood and Garry 2003, Neuendorf 2002). For this study we were able to examine the complete text of all advertisements and supporting materials, not just samples from that material, thereby providing comprehensive analysis of content. We used literal textual analysis to examine all text in the television advertisement audio and video transcripts for language literally consistent with the principles (including synonymous language). In cases where we did not find such content in the television advertisement transcripts, we conducted literal textual analysis of the supplemental materials mentioned in the television advertisements. These included print advertisements, websites, and responses mailed to consumers who made toll- free telephone number requests. In all cases, all text was reviewed and verified independently by two researchers to confirm the findings. No disagreements occurred among the researchers using this method. To support the assessment of principle 3 (educate) and principle 11 (clear and understandable), readability analysis was conducted on several different forms of media, including twenty- four unique television advertisements (Viagra [7], Cialis [12], and Levitra [5]), seventeen unique print advertisements (Viagra [10], Cialis [5], and Levitra [2]), and the patient information for each of the three brands. Following previous researchers in this area (Kaphingst and DeJong 2004), all materials were analyzed using the SMOG readability formula, which estimates the number of years of education required to understand written information (McLaughlin 1969). Print advertisements were divided into two categories for evaluation: the main body and the required brief summary section on side effects, contraindications, and effectiveness that is a statutory requirement in the United States (Code of Federal Regulations 2005 21 CFR 202.1(e)(5)). Finally, to evaluate audience composition relative to principle 13 (audience composition), the gross rating point audience composition data were compared with Nielsens population universal estimates to determine the number of viewers, by age, for each advertisement occurrence.
Results Risks versus Benefits
Principle 2 (accuracy and balance) requires that product claim advertisements be accurate and reflect a balance between risks and benefits consistent with FDA- approved labeling. Principle 10 (conditions and risks) requires that the health condition be identified and that major risks be identified in all television advertisements. According to the Oxford English Dictionary, major is defined as unusually important, serious, or significant. One objective method of evaluating the comparative benefits and risks presented in an advertisement is to assess whether advertisements that include benefits claims also include statements of known major risks. To assess compliance with these two principles, we identified the known major risks of the pharmaceuticals under study. Utilizing the FDA updated labeling for Viagra, Cialis, and Levitra on July 8, 2005, we identified the following common major risks: cardiac risk for preexisting cardiovascular problems that make sexual activity unsafe; risk of unsafe drop in blood pressure for patients taking nitrates; erections lasting more than four hours; and sudden vision loss (US Food and Drug Administration 2005). On October 18, 2007, FDA updated the labels to warn of the major risk of sudden hearing loss (US Food and Drug Administration 2007). All Viagra, Cialis, and Levitra television advertisements broadcast from January 1, 2006, through December 31, 2009, were examined for statements about preexisting cardiovascular problems, risk to patients taking nitrates, erections lasting more than four hours, and sudden vision loss. All advertisements broadcast from January 1, 2008, through December 31, 2009, were examined for statements about sudden hearing loss. All Viagra advertisements for this period were in compliance with the requirement that major risks be included. Twelve of twelve of Cialis advertisements were in compliance with the requirements that preexisting cardiac conditions, nitrate contraindication, and erections lasting longer than four hours be identified. Eleven of twelve Cialis advertisements were in compliance with the requirement that vision loss be identified as a major risk. Six of six Cialis advertisements were in compliance with the requirement that hearing loss be identified as a major risk. For Levitra, five of five advertisements were in compliance with the requirements that preexisting cardiac conditions, nitrate contraindication, and erections lasting longer than four hours be identified. Four of five advertisements were in compliance with the requirement that vision loss be identified as a major risk,
while one of two Levitra advertisements broadcast during the period of study were in compliance with the requirement that hearing loss be identified as a major risk.
Prescription Labeling and Nonprescription Treatment Options
Principle 4 (prescription) requires that television and print advertisements clearly identify the drug as requiring a prescription. All television advertisements for Viagra, Cialis, and Levitra during the four- year period of study provided this information via on- screen text rather than through audible communication. Principle 9 (alternatives) requires companies to provide information about other options for treating health conditions in television and print advertisements. According to the National Kidney and Urologic Diseases Information Clearinghouse, a service of the National Institute of Diabetes and Digestive and Kidney Diseases, options other than prescription medication that can be used to treat erectile dysfunction include quitting smoking, reducing alcohol consumption, losing excess weight, increasing physical activity, reducing or replacing prescription medicines that might be causing erectile dysfunction, and psychotherapy (National Kidney and Urologic Diseases Information Clearinghouse 2006). No television or print advertisement, no patient information sent by mail, and no websites identified in television commercials for Viagra, Cialis, or Levitra provided information about these alternative options for treatment (Pfizer 2010; Lilly USA 2010; and Bayer Pharmaceuticals Corporation, GlaxoSmithKline, and Schering Corporation 2010). Pfizer did, however, indicate surgery as an alternative to the use of Viagra in the treatment section of its website.
Promotion of Health and Disease Awareness and Help for the Uninsured
Principle 14 (disease awareness) encourages companies to promote health and disease awareness as a part of their direct- to- consumer advertising. Erectile dysfunction is recognized by the National Institute of Diabetes and Digestive and Kidney Diseases as a symptom of diseases such as diabetes, high blood pressure, nerve disease or nerve damage, multiple sclerosis, atherosclerosis, and heart disease (National Kidney and Urologic Diseases Information Clearinghouse 2006). All the television advertisements we examined for Viagra, Cialis, or Levitra identified a pharma-
cological treatment for erectile dysfunction. However, none of the seven television advertisements for Viagra and none of the twelve television advertisements for Cialis included disease awareness information. Three of five television advertisements for Levitra explained the relationship between erectile dysfunction and disease. None of the Viagra or Cialis print advertisements included disease awareness information, while only one of the three Levitra print advertisements included disease awareness information. The websites, however, for Viagra, Cialis, and Levitra did effectively provide information about the diseases that may cause erectile dysfunction. Principle 15 (uninsured) encourages companies to provide informato- tion about help for the uninsured or underinsured in all their direct- consumer advertising. No television advertisements for Viagra, Cialis, or Levitra included such information. Neither the print advertisements, nor the information mailed to patients, nor the websites for Cialis or Levitra included such information. However, seven of ten Viagra print advertiseyear period of study did include informaments published during the four- tion for the uninsured. In addition, information about help for the uninsured was provided in the information Pfizer mails to patients and on Pfizers Viagra website.
Educational Value
Readability analysis utilizing the SMOG readability formula was conducted to assess compliance with principle 3 (educate), which requires television and print advertisements to responsibly educate consumers, and principle 11 (clear and understandable) requires that companies pre sent their information in a clear and understandable manner. The SMOG results indicate a consistent reading- level expectation of high school completion (see table 4), with magazine advertisement summary information scoring even higher (12.6213.62). In general, these reading levels significantly exceed recommendations for consumer legibility of patient materials (Doak, Doak, and Root 1996; Root and Stableford 1999). In the United States the average reading level for adult Americans is at the eighth-to ninth- grade level, approximately 20 percent of adults read at the fifth- grade level or below, and for those sixty- five and older, nearly 40 percent read at a level lower than fifth grade (Doak, Doak, and Root 1996).
Table 4 Readability Analysis SMOG Analysis Results Drug Ad Medium SMOG Analysis*
Viagra Magazine ads Main (n = 8) 11.38 (0.59) Summary (n = 1) 12.57 TV ads (n = 7) 9.03 (0.60) Inserts (n = 1) 11.50 Levitra Magazine ads Main (n = 2) 11.12 (0.71) Summary (n = 1) 12.62 TV ads (n = 5) 10.11 (0.59) Inserts (n = 1) 11.50 Cialis Magazine ads Main (n = 5) 11.23 (0.69) Summary (n = 1) 13.62 TV ads (n = 12) 9.00 (0.4) Inserts (n = 1) 11.40
* Mean (standard deviation)
Age-Appropriate Audiences
Principle 13 (audience composition) in the original 2006 PhRMA Guiding Principles in effect from January 1, 2006, to March 1, 2009, requires that audience composition be 80 percent adult (eighteen years and older) for advertisements with adult- oriented content. For the revised guiding principles that took effect on March 2, 2009, according to principle 16, audience composition was required to be 90 percent adult (eighteen years and older) for advertisements with adult messages. Erectile dysfunction advertisements are sexually themed and include statements about sexual activity and erections lasting longer than four hours, making them adult oriented and subject to this principle. Table 5 and figure 1 display the results of the audience composition analysis and include compliance information for both guideline levels (80 percent and 90 percent), by quarter, for each brand (note: the revised guiding principles were implemented on March 2, 2009, occurring partway through the first quarter of 2009 hence, this quarter is represented by two rows in the table, one before and one after the implementation of the revised principles). Under the 80 percent guideline, Viagra displayed reasonable initial compliance, with a rate of violation of only 8.1 percent in the second quar-
Table 5 Audience Composition for Television Occurrences for ED Category and Individual Brands # < 80% % < 80% # < 90% % < 90% # Violations % Violations
Quarter
Brand
Total Ads
Q1 2006 Total 3,645 410 11.1% 2,104 57.7% 410 11.1% Viagra Levitra 755 76 10.1% 507 67.2% 76 10.1% Cialis 2,890 334 11.6% 1,597 55.3% 334 11.6% Q2 2006 Total 3,647 513 14.1% 2,035 55.8% 513 14.1% Viagra 496 40 8.1% 249 50.2% 40 8.1% Levitra 1,207 138 11.4% 665 57.7% 138 11.4% Cialis 1,944 335 17.2% 1,121 42.3% 335 17.2% Q3 2006 Total 6,658 959 14.4% 3,677 55.2% 959 14.4% Viagra 2,290 258 11.3% 1,184 51.7% 258 11.3% Levitra 2,472 523 21.2% 1,632 66.0% 523 21.2% Cialis 1,896 178 9.4% 861 45.4% 178 9.4% Total 5,631 674 12.0% 2,744 48.7% 674 12.0% Q4 2006 Viagra 865 109 12.6% 394 45.5% 109 12.6% Levitra 2,202 313 14.2% 1,276 57.9% 313 14.2% Cialis 2,564 252 9.8% 1,074 41.9% 252 9.8% Year 2006 Total 19,581 2,556 13.1% Viagra 3,651 407 11.1% Levitra 6,636 1,050 15.8% Cialis 9,294 1,099 11.8% Q1 2007 Total 5,348 766 14.3% 2,515 47.0% 766 14.3% Viagra 1,229 246 20.0% 626 50.9% 246 20.0% Levitra 1,826 283 15.5% 947 51.9% 283 15.5% Cialis 2,293 237 10.3% 942 41.1% 237 10.3% (continued)
Table 5 Audience Composition for Television Occurrences for ED Category and Individual Brands (continued) # < 80% % < 80% # < 90% % < 90% # Violations % Violations
Quarter
Brand
Total Ads
Q2 2007 Q3 2007 Q4 2007 Year 2007 Q1 2008 Q2 2008
Total 8,345 Viagra 1,851 Levitra 3,668 Cialis 2,826 Total 10,652 Viagra 2,733 Levitra 4,808 Cialis 3,111 Total 7,111 Viagra 1,207 Levitra 3,750 Cialis 2,154 Total 31,456 Viagra 7,020 Levitra 14,052 Cialis 10,384 Total 9,132 Viagra 3,177 Levitra 3,455 Cialis 2,500 Total 7,445 Viagra 2,033 Levitra 2,866 Cialis 2,546
1,116 13.4% 4,145 49.7% 1,116 13.4% 325 17.6% 877 47.4% 325 17.6% 638 17.4% 2,200 60.0% 638 17.4% 153 5.4% 1,068 37.8% 153 5.4% 1,397 13.1% 5,598 52.6% 1,397 13.1% 600 22.0% 1,709 62.5% 600 22.0% 651 13.6% 2,577 53.6% 651 13.6% 146 4.7% 1,312 42.2% 146 4.7% 798 11.2% 3,586 50.4% 798 11.2% 155 12.8% 631 52.3% 155 12.8% 520 13.9% 1,900 50.7% 520 13.9% 123 5.7% 1,055 49.0% 123 5.7% 4,077 13.0% 1,326 18.9% 2,092 14.9% 659 6.3% 1,291 14.1% 4,982 54.6% 1,291 14.1% 657 20.7% 2,000 63.0% 657 20.7% 558 16.2% 2,023 58.6% 558 16.2% 76 3.0% 959 38.4% 76 3.0% 836 11.2% 4,222 56.7% 836 11.2% 214 10.5% 1,057 52.0% 214 10.5% 471 16.4% 1,927 67.2% 471 16.4% 151 5.9% 1,238 48.6% 151 5.9%
Table 5 (continued) # < 80% % < 80% # < 90% % < 90% # Violations % Violations
Quarter
Brand
Total Ads
Q3 2008 Total 6,525 774 11.9% 3,809 58.4% 774 11.9% Viagra 2,659 346 13.0% 1,611 60.6% 346 13.0% Levitra 1,749 301 17.2% 1,120 64.0% 301 17.2% Cialis 2,117 127 6.0% 1,078 50.9% 127 6.0% Q4 2008 Total 4,106 375 9.1% 2,156 52.5% 375 9.1% Viagra 2,085 285 13.7% 1,143 54.8% 285 13.7% Levitra 182 17 9.3% 94 51.6% 17 9.3% Cialis 1,839 73 4.0% 919 50.0% 73 4.0% Year 2008 Total 27,208 3,276 12.0% Viagra 9,954 1,502 15.1% Levitra 8,252 1,347 16.3% Cialis 9,002 427 4.7% Q1 2009 Total 3,806 497 13.1% 2,083 54.7% 497 13.1% (JanMar 1) Viagra 1,427 345 24.2% 478 66.5% 345 24.2% Levitra 1,116 107 9.6% 526 52.9% 107 9.6% Cialis 1,263 45 3.6% 719 43.1% 45 3.6% Total 2,086 250 12.0% 1,112 53.3% 1,112 53.3% Q1 2009 Viagra 1,049 187 17.8% 676 64.4% 676 64.4% (Mar 231) Levitra 376 51 13.6% 213 56.6% 213 56.6% Cialis 661 12 1.8% 223 33.7% 223 33.7% Q2 2009 Total 5,510 455 8.3% 2,949 53.5% 2,949 53.5% Viagra 1,974 224 11.3% 1,156 58.6% 1,156 58.6% Levitra 1,106 121 10.9% 697 63.0% 697 63.0% Cialis 2,430 110 4.5% 1,096 45.1% 1,096 45.1% (continued)
Table 5 Audience Composition for Television Occurrences for ED Category and Individual Brands (continued) # < 80% % < 80% # < 90% % < 90% # Violations % Violations
Quarter
Brand
Total Ads
Q3 2009 Q4 2009 Total 2009 Total Original Guidelines Total New Guidelines Total 20062009
Total 5,375 531 9.9% 3,006 55.9% 3,006 55.9% Viagra 1,874 252 13.4% 1,066 56.9% 1,066 56.9% Levitra 857 122 14.2% 619 72.2% 619 72.2% Cialis 2,644 157 5.9% 1,321 50.0% 1,321 50.0% Total 4,800 500 10.4% 2,878 60.0% 2,878 60.0% Viagra 2,043 300 14.7% 1,266 62.0% 1,266 62.0% Levitra 758 92 12.1% 499 65.8% 499 65.8% Cialis 1,999 108 5.4% 1,113 55.7% 1,113 55.7% Total 21,577 10,442 48.4% Viagra 8,367 4,509 53.9% Levitra 4,213 2,135 50.7% Cialis 8,997 3,798 42.2% Total 82,051 10,406 12.0% Viagra 22,052 3,580 16.2% Levitra 30,056 4,596 15.3% Cialis 29,943 2,230 7.4% Total 17,771 9,945 56.0% Viagra 6,940 4,164 60.0% Levitra 3,097 2,028 65.5% Cialis 7,734 3,753 48.5% Total 99,822 20,351 20.4% Viagra 28,992 7,744 26.7% Levitra 33,153 6,624 20.0% Cialis 37,677 5,983 15.9%
From 2006 through March 1, 2009, the target audience expectations were 80% of the viewing audience aged 18+. On March 2, 2009, new guidelines were introduced, shifting the target audience expectations from 80% to 90%.
Figure 1. Percent Television Occurrences in Violation of Target Audience 18+) for531 ED n Politics and Strategy of Industry Self- Arnold andof Oakley R(Age egulation Category and Individual Brands
Figure 1 Percent of Television Occurrences in Violation of Target Audience (Age 18+) for ED Category and Individual Brands
ter of 2006 (Viagra did not run any television advertisements in the first quarter of 2006). However, Viagra is found to have engaged in the highest rate of violation at 24.2 percent in the first quarter of 2009 (January 1 March 1, 2009), with 345 occurrences (out of 1,427 total occurrences) having an audience composition of less than 80 percent aged eighteen years and older. Cialis showed improvement over the three years under the original PhRMA Guiding Principles, starting at 11.6 percent in the first quarter of 2006 before rising to 17.2 percent in the second quarter of 2006, but falling to a level below 10 percent consistently from the third quarter of 2006 through the first quarter of 2009, where the rate of violation ranged from 3.0 percent to 10.3 percent. Levitra was consistently in the middle, ranging from 9.3 percent to 21.2 percent violations. According to the new guidelines, it is now expected that 90 percent of the audience for these advertisements will be eighteen years or older. As shown in table 5, at no point have the three brands in this category successfully complied with this guideline at a rate better than 50 percent for the total category. Cialis has consistently been the most compliant of the three brands, with rates of violation ranging from 33.7 percent to 55.7
percent (though the trend shows an increasing rate of violation over time). Viagras rate of violation has ranged from 56.9 percent to 64.4 percent, and Levitra has ranged from 56.6 percent to 72.2 percent. Clearly, the change in the guiding principles did not result in a change in behavior for the three brands under study, with the category displaying an overall 56.0 percent rate of violation from March 2 to December 31, 2009. Over the four- year period from January 1, 2006, to December 31, 2009, American consumers were exposed to 99,822 television advertisements for erectile dysfunction, with 31,456 being the most in a single year (2007). From the nearly 100,000 total advertising occurrences, we estimate close to 500 billion total advertising impressions (based on an average audience size of 5 million per occurrence over the 99,822 total occurrences), of which over 100 billion impressions were to consumers under the age of eighteen. Impressions represent a single exposure to an advertisement or advertising message, and are frequently utilized as a measure of advertising effectiveness (Danaher, Lee, and Kerbache 2010; Roth and Malkewitz 2008). We estimate that Viagra commercials were viewed by children approximately 30 billion times, Cialis approximately 38 billion times, and Levitra approximately 34 billion times during the four- year period we studied. In total, children were exposed to a total of over 100 billion erectile dysfunction impressions via television commercials during the period of study.
Reporting Violations
While not part of the specific DTCA guiding principles, the PhRMA Office of Accountability provides consumers, health care professionals, and other interested parties the opportunity to provide comments on company compliance with the guiding principles via conventional mail or facsimile. The PhRMA website provides a form as well as instructions for submitting it. The Office of Accountability states that comments will be forwarded to individual companies (PhRMA 2006). To determine how companies track compliance with principle 13, we attempted to file comments with the Office of Accountability for each erectile dysfunction pharmaceutical brand. We sought clarification about the manner by which individual companies have confirmed compliance with principle 13 (audience composition). We submitted comments by mail on March 22, 2010. After six weeks and no response, we resubmitted our comments by mail and obtained confirmation of delivery on May 6, 2010, by the US Postal Service. We also made repeated efforts to submit comment
Table 6 Summary of Compliance Results for Television and Print Advertisements Compliance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Shorthand Preamble Accuracy and Balance Educate Prescription Patient-Doctor Communication Detailing Safety Risk FDA Submission Alternatives Conditions and Risks Clear and Understandable Serious Audience Composition Disease Awareness Uninsured Assessed Viagra Levitra Cialis N Y Y P P Y N N N Y Y Y Y N N N N Y N N N Y Y P P Y N N N N Y N N N Y N P N Y P N N
Key: Y = Yes, N = No, P = Partial
forms by facsimile beginning in May 2010, but the incoming calls at the number provided by PhRMA were not picked up by a facsimile machine on different days and at different times. We continued this effort until July 23, 2010, when on the eleventh attempt a facsimile was confirmed as delivered. In the meantime, comments were again mailed to the PhRMA Office of Accountability on July 13, 2010. No response to any of these comments was ever received from PhRMA or from Bayer Healthcare, Eli Lilly, GlaxoSmithKline, Schering Plough, Merck, or Pfizer as of December 27, 2012.
Summary
Violations of the Pharmaceutical Research and Manufacturers of Americas Guiding Principles for Direct to Consumer Advertising for Prescription Medicines by Pfizer, Eli Lilly, Bayer Healthcare, GlaxoSmithKline, and Schering Plough/Merck were routine during the four- year period of our study. Of the nine principles we assessed for compliance (our results are summarized in table 6), there was a consistent pattern of noncompliance among the direct- to- consumer advertising for all three brands under
study. The Pharmaceutical Research and Manufacturers of America does not make public the violations of its guiding principles, nor does it sanction members for violation of the principles, nor did it respond to comments that were filed. During the four- year period of study, none of the companies provided consumers with information about the nondrug, nonsurgical options for treatment recommended by the National Institute of Diabetes and Digestive and Kidney Diseases, in contravention of principle 9 (alternatives), and few advertisements provided information about the relationship between diseases and erectile dysfunction, in contravention of principle 14 (disease awareness). Instead, the advertisements contained substantial nonmedical information. Each drug is presented in advertisements as the most appropriate first- stage treatment for impotence despite known risks such as priapism and sudden loss of vision or hearing. Furthermore, the risks of vision and hearing loss were not always provided in the tele vision advertisements, in contravention of principle 7 (safety risk). What information was provided was often done at a level not comprehensible to average Americans, and especially to those over sixty- five. This finding is consistent with previous research undertaken on the literacy demands of earlier advertising campaigns for pharmaceuticals (Kaphingst et al. 2004). Cumulatively our data show that erectile dysfunction marketing campaigns fail to responsibly educate consumers about health conditions and appropriate treatments, in breach of principle 3 (educate). Our findings are consistent with research on DTCA undertaken prior to the period in which the guiding principles were introduced. Such research concluded that DTCA is intended to convince consumers to request specific products from physicians rather than to provide public health education (Frosch et al. 2007; Kaphingst and DeJong 2004; Main, Argo, and Huhmann 2004). There are two core interests at stake in direct- to- consumer pharmaceutical marketing: (1) the interest of pharmaceutical companies to increase sales of drugs that they bring to the marketplace, especially those that remain under patent protection; and (2) the publics interest in health education and patient welfare. Pharmaceutical industry self- regulation has the potential to enhance public health via public health education while reducing transactions costs for individual companies. Such a code could be produced in consultation with leading public health educators and governmental agencies and would carry serious sanctions for code violations to ensure compliance. Since all signatory companies would be subject to the same standards, no company would gain competitive advantage from engaging in persuasive marketing at the expense of health educa-
tion. While current industry guidelines on DTCA may be imperfect, if the guidelines were consistently followed by signatory companies, they have the potential to better balance these competing interests. Prior to the implementation of the PhRMA Guiding Principles, some health policy scholars argued that pharmaceutical company self- regulation might by itself result in high- quality public health education via television and print advertisements (Kaphingst and DeJong 2004). The results of our study show that the principles have not achieved this aim in the case of erectile dysfunction advertisements.
Self- Regulation as a Collective Blocking Strategy
As we explained above, corporate public affairs strategies have previously been characterized as falling into two categories: buffering and bridging (Fennel and Alexander 1987; Meznar and Nigh 1995). Here we introduce a third strategy for corporate public affairs, which we call blocking, in order to provide a theoretical explanation for our findings. A blocking strategy occurs when a firm publicly characterizes itself as engaged in bridging activity but is in reality engaged in activity that blocks unwanted external constraints on its activities. When a firm engages in a blocking strategy, it represents itself as responding proactively to social expectations about firm behavior in a manner consistent with a bridging strategy but does not implement the internal measures necessary to ensure that the bridging strategy is implemented. For example, an individual firm might produce and publicize an ethics policy without providing corresponding employee ethics training or holding employees accountable for following the policy. Within an industry, firms might collectively utilize a trade group to write and promulgate industry standards that are violated without sanction. We suggest that industry self- regulation may be utilized not merely to enhance relationships with stakeholders but as a political mechanism to deflect external stakeholder criticism and block new governmental oversight or regulation. A blocking strategy is similar to a buffering strategy in that its goal is to minimize the impact of external pressure on firm behavior, and it is similar to a bridging strategy in its development and stated use of pro active measures to meet external expectations. However, it differs from both buffering and bridging in being deceptive, whereby bridging techniques are not utilized authentically with the intention of altering firm or industry behavior to meet social expectations but are instead a ruse or smokescreen
intended to disguise the actual intentions of the firm or industry. When a blocking strategy is being utilized, top management commitment to a set of values or principles is a feature of the deceptive strategy rather than a manifestation of organization commitment to the values or principles. A collective blocking strategy has the following components: (1) it is facilitated by an industry trade group via an industrywide code of conduct, (2) it is a response to the perceived threat of additional regulatory oversight, (3) the code of conduct is routinely violated by companies that have agreed to follow the code, and (4) the code of conduct is not enforced by the trade group. Recall that all five of the companies examined in our study have committed to internal processes to ensure compliance with the principles, have certified compliance with the principles, and have had their chief executive and the chief compliance officer attest to compliance. Our data provide evidence to support the conclusion that the Pharmaceutical Research and Manufacturers of America trade association is facilitating a collective blocking strategy regarding the regulation of direct- to- consumer marketing in the United States. To further support this explanation of trade group and company behavior, it is useful to examine the history of one recently proposed regulation for erectile dysfunction advertisements. In March 2005 US representatives Jim Moran of Virginia and John J. Duncan Jr. of Tennessee introduced the Families for ED Decency Advertising Act (H.R. 1420) in the 109th Congress in response to the advertising of erectile dysfunction advertisements on television. The act would have restricted the hours during which erectile dysfunction advertising may be broadcast to between 10:00 p.m. and 6:00 a.m. (Moran 2005). When PhRMAs guiding principles were initially introduced, it was reported in the media that the self- regulatory effort was designed to prevent stricter federal regulation (Pear 2005; Saul 2005). H.R. 1420 was allowed to die in subcommittee after Representative Moran received a commitment from pharmaceutical company executives to self- regulate these advertisements (Moran 2009). The PhRMA principles on audience composition (principles 13 and 16 in the revised guidelines) currently requires that advertisements with adult content be broadcast when 90 percent of the viewing audience is eighteen or older. This principle recognizes that children may be adversely affected by exposure to explicit discussions of certain medical conditions or sexual activity. All erectile dysfunction advertisements refer to erections lasting longer than four hours. Parents and other viewers concerned about objectionable language believe that such content should be restricted to later broadcast hours (Pew Research Center for People and
the Press 2005).1 The Families for ED Advertising Decency Act (H.R. 2175) was reintroduced in the US House of Representatives in April 2009. At that time, Representative Moran stated in an open letter to the heads of Eli Lilly, Pfizer, and GlaxoSmithKline that the verbal agreement to tone down advertisements and limit their airing before 10 p.m. had been violated (Moran 2009). The public responses of both Eli Lilly and GlaxoSmithKline to H.R. 2175 stated that federal regulation is not needed because the companies advertise only during programming in which the viewing audience is 90 percent adult, consistent with the guiding principles, while Pfizer stated that it was in compliance with industry policies (Berman, Shaylor, and Ibanga 2009). H.R. 2175 died in subcommittee. Our data show that Pfizer, Eli Lilly, Bayer Healthcare, GlaxoSmithKline, and Merck have not complied with the PhRMA principle put in place to protect children for any quarter during the four- year period we studied. Rather, our results show that the advertising efforts for ED drugs resulted in approximately 100 billion advertising impressions reaching children year period under study. under eighteen during the four- regulation Our conclusions provide evidence to support the idea that self- can be utilized as a way to prevent new governmental regulations while allowing companies to engage in practices consonant with their independent strategic aims through a collective blocking strategy. The idea that the pharmaceutical industry utilizes a collective blocking strategy is also consistent with the findings of Devlin and her colleagues in the United Kingdom (Devlin et al. 2007).2 This demonstrates that a failure to adhere regulatory codes in the pharmaceutical industry is not restricted to to self- a particular type of marketing or to a particular national market.3
1. Parents who restrict their children from watching adult programming cannot prevent them from seeing advertisements for erectile dysfunction pharmaceuticals when they are aired during sporting events, news broadcasts, and other programming commonly viewed by families. Reference to sexual activity in erectile dysfunction advertisements is unlikely to be regarded as patently offensive by contemporary community standards; thus these advertisements do not currently fall under the jurisdiction of the Federal Communications Commission. 2. In the UK, prescription- only medicines cannot be marketed directly to the public, and marketing to health professionals is self- regulated by the Association of the British Pharmaceutical Industrys (ABPI) Code of Practice. Devlin and her colleagues found that the ABPI Code of Practice was seriously violated by GlaxoSmithKline, AstraZeneca, Pfizer, Eli Lilly, and Wyeth in the marketing of nine different pharmaceuticals. They argue that policy changes are needed to ensure the integrity of pharmaceutical company marketing to physicians (Devlin et al. 2007). 3. A similar strategy may be practiced in other industries that affect public health, such as food or tobacco (for discussion of self- regulation in these industries, see Brownell and Warner 2009 and Mello 2010).
Policy Recommendations
Pharmaceutical industry claims to engage in self- regulation for DTCA should be regarded with skepticism by stakeholders and policy makers. There are several possible public policy responses to a failure of industry to self- regulate DTCA. First, in jurisdictions such as the European Union that permit bans on DTCA, such bans can be retained. Second, in the United States or New Zealand, more robust regulatory regimes may be put in place. Such regulations might, for example, seek to ensure that children are protected from non- age- appropriate messages consistent with the Families for ED Advertising Decency Act. They might also require that nonpharmacological treatment options and comparative treatment costs be addressed and that FDA approval of advertisements take place before advertisements are broadcast for the first time. Companies might also be assessed a fee for each DTCA broadcast to enable the National Library of Medicine to produce and widely distribute plain- language information about the benefits, harms, and cost of the drugs advertised as well as information about the condition and nonpharmacological treatment options.4 In New Zealand, some of these changes might be introduced via amendments to the existing Code for Therapeutic Advertising by the Advertising Standards Authority, while others could be introduced by the Ministry of Health. In the United States, the ability of Congress and the FDA to implement such regulatory changes will be subject to the evolving role of the Supreme Court in assessing what constraints may be placed on commercial speech. However, Congress might empower existing agencies or departments to penalize firms for making false claims about their advertising. Third, within existing regulatory frameworks additional resources should be provided to regulatory agencies for more rigorous enforcement of statutory requirements. The ultimate goal of these recommendations is to better balance the interests of pharmaceutical companies and the public.
4. The idea is to obtain the total number of times individual companies broadcast advertisements in a given year from Nielsen or another source and to assess a fee per broadcast. One payment would be made annually to the federal government, and those resources would fund the work of the National Library of Medicine. The library would provide more detailed information than Medline Plus currently provides, including the estimated costs of each available medication. The information would be published on the Internet and made available to individuals in brochures obtained via telephone requests. Significantly, all this information should be provided in plain language accessible to someone with an eighth- grade reading level. More detailed information for more sophisticated readers could also be made available. Consumers Union does something similar at present on its Consumer Reports Best Buy Drugs website, but our suggested model is more comprehensive and would provide a consistent long- t erm funding source.
Limitations
As with all empirical research, our study is not without limitations. As noted at the beginning of the article, PhRMA principles 6, 7, and 8 do not allow for independent verification, so compliance was not evaluated. In addition, while principle 5 is measurable, it is beyond the scope of the present article. It is possible that companies complied with one or more of these principles during the period of our study. In evaluating the readability of the advertisements themselves, the advertisements evaluated were those airing or in print during 2006 2009. While every effort was made to identify and obtain all active advertisements during this time frame, there may have been additional executions that were not identified and thus not analyzed. In addition, our study focuses on a particular class of pharmaceuticals, and the five companies that produce and market those products. Research that assessed compliance with the guiding principles for other pharmaceuticals marketed by both these companies and other pharmaceutical companies would offer additional insight into company compliance with PhRMAs guiding principles. In particular, additional empirical evidence both from the analysis of additional pharmaceutical advertising campaigns and from internal corporate and marketing agency communications would prove useful in assessing the validity of our explanation of company behavior.
References
Abraham, John. 2009. Partial Progress: Governing the Pharmaceutical Industry 2008. Journal of Health Politics, Policy and Law 34, no. 6: and the NHS, 1948 93177. Abramson, John. 2004. Overdosed America. New York: HarperCollins. American Academy of Pediatrics Committee on Communication. 2006. Children, 69. Adolescents, and Advertising. Pediatrics 118, no. 6: 2563 Angell, Marcia. 2004. The Truth about the Drug Companies. New York: Random House. Arnold, Denis G. 2009. The Ethics of Direct to Consumer Advertising. In Ethics and the Business of Biomedicine, edited by Denis G. Arnold, 131 49. Cambridge: Cambridge University Press. Arrow, Kenneth J. 1963. Uncertainty and the Welfare Economics of Medical Care. 73. American Economic Review 53, no. 5: 941 Avorn, Jerry. 2004. Powerful Medicines. New York: Random House.
Bayer Pharmaceuticals Corporation, GlaxoSmithKline, and Schering Corporation. 2010. Levitra (vardenafil HCI). www.levitra.com/ (accessed June 30, 2010). Berman, John, Jay Shaylor, and Imaeyen Ibanga. 2009. Are Erectile Dysfunction Ads Too Sexy? ABCNews.com, May 15. http://abcnews.go.com/GMA/story ?id=7591580&page=1. Brownell, Kelly D., and Kenneth E. Warner. 2009. The Perils of Ignoring History: Big Tobacco Played Dirty and Millions Died. How Similar Is Big Food? Milbank 94. Quarterly 87, no. 1: 259 to- Consumer Advertising of Calfee, John E. 2002. Public Policy Issues in Direct- 93. Prescription Drugs. Journal of Public Policy and Marketing 21, no. 2: 174 Capella, Michael L., et al. 2009. Do Pharmaceutical Marketing Activities Raise Prices? Evidence from Five Major Therapeutic Classes. Journal of Public Policy 61. and Marketing 28, no. 2: 146 Conrad, Peter, and Valerie Leiter. 2004. Medicalization, Markets, and Consumers. 76. Journal of Health and Social Behavior 45 (suppl.): 158 Danaher, Peter J., Janghyuk Lee, and Laoucine Kerbache. 2010. Optimal Internet 47. Media Selection. Marketing Science 29, no. 2: 336 to- Consumer AdvertisDatti, Balaji, and Mary W. Carter. 2006. The Effect of Direct- ing on Prescription Drug Use by Older Adults. Drugs and Aging 23, no. 1: 71 81. to- Consumer AdverDave, Dhaval M., and Henry Saffer. 2010. The Impact of Direct- tising on Pharmaceutical Prices and Demand. NBER Working Paper No. w15969. Cambridge, MA: National Bureau of Economic Research. Davies, Peter, Brian Steinberg, and Zachery A. Goldfarb. 2005. Drug Makers Scramble to Respond to Ad Curbs. Wall Street Journal, July 5. Devlin, Elinor, et al. 2007. Pharmaceutical Marketing: A Question of Regulation. Journal of Public Affairs 7, no. 2: 135 47. Doak, Cecilia C., Leonard G. Doak, and Jane H. Root. 1996. Teaching Patients with Low Literacy Skills. 2nd ed. Philadelphia: J. B. Lippincott. Donohue, Julie M., Marisa Cevasco, and Meredith B. Rosenthal. 2007. A Decade of to- Consumer Advertising of Prescription Drugs. New England Journal of Direct- 81. Medicine 357, no. 7: 673 Eisenhardt, Kathleen M. 1989. Building Theories from Case Study Research. Acad 50. emy of Management Review 14, no. 4: 532 Fennel, Mary L., and Jeffrey A. Alexander. 1987. Organizational Boundary Spanning in Institutionalized Environments. Academy of Management Journal 30, no. 3: 45676. Fortune. 2009. Fortune Global 500 2009 Pharmaceutical Industry. http://money.cnn .com/magazines/fortune/fortune500/2009/industries/21/index.html. Friedman, Michael, and James Gould. 2007. Attitudes and Opinions of Pharmacists to- Consumer Prescription Drug Marketing. Journal of Pharmaceutoward Direct- 97. tical Finance, Economics, and Policy 16, no. 3: 85 Frosch, Dominick L., et al. 2007. Creating a Demand for Prescription Drugs: A Content Analysis of Television Direct- to- Consumer Advertising. Annals of Family 13. Medicine 5, no. 1: 6 Geyer, Robert. 2011. The Politics of EU Health Policy and the Case of Direct- to-
Consumer Advertising for Prescription Drugs. British Journal of Politics and International Relations 13: 586602. Hammer, Peter J., et al., eds. 2003. Uncertain Times: Kenneth Arrow and the Changing Economics of Health Care. Durham, NC: Duke University Press. Lou Coleman. 2007. News Media Coverage of Direct- Hartley, Heather, and Cynthia- to- Consumer Pharmaceutical Advertising: Implications for Countervailing Powers Theory. Health 12, no. 1: 107 32. Harwood, Tracy G., and Tony Garry. 2003. An Overview of Content Analysis. Mar 98. keting Review 3, no. 4: 479 Havinghurst, Clark C. 1995. Health Care Choices: Private Contracts as Instruments of Health Reform. Washington, DC: American Enterprise Institute. to- Consumer Marketing of Prescription Drugs: CreHollon, Matthew F. 1999. Direct- ating Consumer Demand. Journal of the American Medical Association 281, no. 4: 38284. to- Consumer Prescription Drug Advertising Builds Holmer, Alan F. 1999. Direct- Bridges between Patients and Physicians. Journal of the American Medical Asso 82. ciation 281, no. 4: 380 to- Consumer Advertising: Strengthening Our Health Holmer, Alan F. 2002. Direct- Care System. New England Journal of Medicine 346, no. 7: 526 88. Kaphingst, Kimberly A., et al. 2004. Literacy Demands of Product Information to- Consumer Prescription Drug AdverIntended to Supplement Television Direct- 300. tisements. Patient Education and Counseling 55, no. 2: 293 Kaphingst, Kimberly A., and William DeJong. 2004. The Educational Potential of to- Consumer Prescription Drug Advertising. Health Affairs 23, no. 4: 14350. Direct- Kassarjian, Harold H. 1977. Content Analysis in Consumer Research. Journal of 18. Consumer Research 4, no. 1: 8 Regulation without King, Andrew A., and Michael J. Lenox. 2000. Industry Self- Sanctions: The Chemical Industrys Responsible Care Program. Academy of Man 716. agement Journal 43, no. 4: 698 L evel Kolsarici, Ceren, and Demetrios Vakratsas. 2010. Category-versus Brand- Advertising Messages in a Highly Regulated Environment. Journal of Marketing Research 47, no. 6: 1078 89. LaBarbera, Priscilla A. 1983. The Diffusion of Trade Association Advertising Self- Regulation. Journal of Marketing 47, no. 4: 58 67. Law, Michael R., et al. 2009. Costs and Consequences of Direct- to- Consumer Advertising for Clopidogrel in Medicaid. Archives of Internal Medicine 169, no. 21: 196974. to- Consumer Advertising of PreLexchin, Joel, and Barbara Mintzes. 2002. Direct- scription Drugs: The Evidence Says No. Journal of Public Policy and Marketing 21, no. 2: 194 201. Lilly USA. 2010. Cialis (Tadalafil) Tablets. www.cialis.com/Pages/index.aspx (accessed June 30, 2010). Main, Kelly J., Jennifer J. Argo, and Bruce A. Huhmann. 2004. Pharmaceutical Advertising in the USA: Information or Influence? International Journal of Advertising 23, no. 1: 119 42.
McLaughlin, G. Harry. 1969. SMOG Grading a New Readability Formula. Journal of Reading 12, no. 8: 639 46. Mello, Michelle M. 2010. Federal Trade Commission Regulation of Food Advertising to Children: Possibilities for a Reinvigorated Role. Journal of Health Politics, 76. Policy and Law 35, no. 2: 227 Meznar, Martin B., and Douglas Nigh. 1995. Buffer or Bridge? Environmental and Organizational Determinants of Public Affairs Activities in American Firms. 96. Academy of Management Journal 38, no. 4: 975 to- Consumer Advertising (DTCA) Mintzes, Barbara, et al. 2003. How Does Direct- Affect Prescribing? A Survey in Primary Care Environments with and without 12. Legal DTCA. Canadian Medical Association Journal 169, no. 5: 405 Moran, James P. 2005. Congressional Record, vol. 151, pt. 4, March 17, 5430. Moran, James P. 2009. Letter, May 19, http://moran.house.gov/list/press/va08_moran /EDads.shtml. to- Consumer Myers, Susan D., Marla B. Royne, and George D. Deitz. 2011. Direct- Advertising: Exposure, Behavior, and Policy Issues. Journal of Public Policy and 18. Marketing 30, no. 1: 110 Nash, Jennifer, Jennifer A. Howard, and John Ehrenfeld. 2000. Standard or Smokescreen? Implementation of a Voluntary Environmental Code. California Management Review 42, no. 2: 63 82. National Kidney and Urologic Diseases Information Clearinghouse, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health of the US Department of Health and Human Services. 2006. Erectile Dysfunction, June, Pub. No. 093923. Neuendorf, Kimberly A. 2002. The Content Analysis Guidebook. Thousand Oaks, CA: Sage. Pear, Robert. 2005. Drug Industry Is Said to Work on an Ad Code. New York Times, May 16. Pew Research Center for People and the Press. 2005. Support for Tougher Indecency Measures, but Worries about Government Intrusiveness. April 19. http://people -press.org/reports/pdf/241.pdf. Pfizer. 2010. Viagra (Sildenafil Citrate) Tablet. www.viagra.com/index.aspx (accessed June 30, 2010). Pharmaceutical Research and Manufacturers of America (PhRMA). 2004. Pharmaceutical Marketing and Promotion Q&A: Tough Questions, Straight Answers. Washington, DC: PhRMA. Pharmaceutical Research and Manufacturers of America (PhRMA). 2005. PhRMA Guiding Principles: Direct to Consumer Advertisements about Prescription Medicines. November. Washington, DC: PhRMA. Pharmaceutical Research and Manufacturers of America (PhRMA). 2006. PhRMA Statement on DTC Office of Accountability. July 7. Washington, DC. Pharmaceutical Research and Manufacturers of America (PhRMA). 2008. PhRMA Guiding Principles: Direct to Consumer Advertisements about Prescription Medicines. December. Washington, DC: PhRMA. Pharmaceutical Research and Manufacturers of America (PhRMA). 2009. PhRMA Guid-
ing Principles: Direct to Consumer Advertisements about Prescription Medicines Signatory Companies. www.phrma.org/sites/default/files/106/signatory_companies _dtc_principles_080610.pdf. Pharmaceutical Research and Manufacturers of America (PhRMA). n.d. PhRMA Direct to Consumer Advertising PrinciplesAnnual Certifications. www.phrma.org /sites/phrma.org/files/attachments/050310_2010_Certifications_DTC_Principles .pdf (accessed June 30, 2010). Pines, Wayne L. 1999. A History and Perspective on Direct- to- Consumer Promotion. Food and Drug Law Journal 54, no. 4: 489 518. Root, Jane, and Sue Stableford. 1999. Easy- to- Read Consumer Communications: A Missing Link in Medicaid Managed Care. Journal of Health Politics, Policy and Law 24, no. 1: 1 26. Rotfeld, Herbert J., Avery M. Abernethy, and Patrick R. Parsons. 1990. Self- Regulation and Television Advertising. Journal of Advertising 19, no. 4: 18 26. Roth, Ulrich R., and Keven Malkewitz. 2008. Holistic Package Design and Consumer Brand Impressions. Journal of Marketing 72, no. 3: 64 81. Royne, Marla B., and Susan D. Myers. 2008. Recognizing Consumer Issues in DTC Pharmaceutical Advertising. Journal of Consumer Affairs 42, no. 1: 60 80. Saul, Stephanie. 2005. Drug Makers to Police Consumer Campaigns. New York Times, August 3. Short, Jodi L., and Michael W. Toffel. 2010. Making Self- Regulation More Than Merely Symbolic: The Critical Role of the Legal Environment. Administrative Science Quarterly 55: 36196. Shuchman, Miriam. 2007. Drug Risks and Free Speech: Can Congress Ban Consumer Drug Ads? New England Journal of Medicine 356, no. 22: 2236 39. Stone, Deborah. 1977. Professionalism and Accountability: Controlling Health Services in the United States and West Germany. Journal of Health Politics, Policy and Law 2, no. 1: 32 47. Strasburger, Victor C. 2004. Children, Adolescents, and the Media. Current Problems in Pediatric and Adolescent Health Care 34, no. 2: 54 113. US Food and Drug Administration. 2005. FDA Updates Labeling for Viagra, Cialis, and Levitra for Rare Post- Marketing Reports of Eye Problems. July 8. www.fda.gov /NewsEvents/Newsroom/PressAnnouncements/2005/ucm108458.htm. US Food and Drug Administration. 2007. FDA Announces Revisions to Labels for Cialis, Levitra, and Viagra. October 18. www.fda.gov/NewsEvents/Newsroom /PressAnnouncements/2007/ucm109012.htm. US Food and Drug Administration. 2008. Warning Letter for YAZ (Drospirenone and Ethinyl Estradiol) Tablets. October 3. www.fda.gov/downloads/Drugs /GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm 053993.pdf. US Food and Drug Administration. 2009. Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion. May. Vogt, Donna. 2005. Direct- to- Consumer Advertising of Prescription Drugs. Report No. RL32853, March 25. Washington, DC: US Congressional Research Service.
Weaver, Gary R., Linda Klebe Trevio, and Philip L. Cochran. 1999. Corporate Ethics Programs as Control Systems: Influences of Executive Commitment and Envi 57. ronmental Factors. Academy of Management Journal 42, no. 1: 41 Weissman, Joel S., et al. 2003. Consumers Reports on the Health Effects of Direct- to- Consumer Drug Advertising. Health Affairs W3, January: 82 95. Weissman, Joel S., et al. 2004. Physicians Report on Patient Encounters Involving 33. Direct-to-Consumer Advertising. Health Affairs W4, April: 219 to- Consumer Advertising: Education or Emotion ProWolfe, Sidney M. 2002. Direct- 26. motion? New England Journal of Medicine 346, no. 7: 524 to- Consumer Advertisements for Prescription Woloshin, Steven, et al. 2001. Direct- 46. Drugs: What Are Americans Being Sold? Lancet 358, no. 9288: 1141

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Journal of Health Politics, Policy and Law Advance Publication, published on February 15, 2013

Prescription Drugs and Administrative Costs

Copyright 2013 by Duke University Press

506 Journal of Health Politics, Policy and Law

508 Journal of Health Politics, Policy and Law

Table 2 PhRMA DTC Guiding Principles

Risks vs. Benefits

Empirically Original Guidelines Revised Guidelines Shorthand Assessable

Promotion of Health and Disease Awareness Disease Awareness Uninsured Y Y

Empirically Original Guidelines Revised Guidelines Shorthand Assessable

Clear and Understandable

Table 2 PhRMA DTC Guiding Principles (continued )

Empirically Original Guidelines Revised Guidelines Shorthand Assessable

Unable to Assess Empirically Preamble N

Empirically Original Guidelines Revised Guidelines Shorthand Assessable

Table 2 PhRMA DTC Guiding Principles (continued )

Empirically Original Guidelines Revised Guidelines Shorthand Assessable

FDA Submission Serious MedWatch

Empirically Original Guidelines Revised Guidelines Shorthand Assessable

516 Journal of Health Politics, Policy and Law

Source: TNS/Kantar Media Intelligence Ad$pender

518 Journal of Health Politics, Policy and Law

520 Journal of Health Politics, Policy and Law

522 Journal of Health Politics, Policy and Law

Results Risks versus Benefits

524 Journal of Health Politics, Policy and Law

526 Journal of Health Politics, Policy and Law

Q2 2007 Q3 2007 Q4 2007 Year 2007 Q1 2008 Q2 2008

532 Journal of Health Politics, Policy and Law

Key: Y = Yes, N = No, P = Partial

534 Journal of Health Politics, Policy and Law

536 Journal of Health Politics, Policy and Law

538 Journal of Health Politics, Policy and Law

540 Journal of Health Politics, Policy and Law

542 Journal of Health Politics, Policy and Law

544 Journal of Health Politics, Policy and Law

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