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The Educational Potential Of Direct-To-Consumer Prescription Drug Advertising

Abstract

 
Food and Drug Administration (FDA) regulations for direct-to-consumer (DTC) prescription drug advertising allow broadcast advertisements with incomplete risk information if the ads refer consumers to physicians, pharmacists, and supplemental information sources. New research reveals several problems with both television advertisements and supplemental text materials that might compromise their ability to meet the FDA’s requirement for "fair balance" in the presentation of risks and benefits. In response, we make several recommendations to improve the educational quality of DTC advertising, which can be implemented through either voluntary agreements or revised FDA regulations.

FDA policies. According to U.S. Food and Drug Administration (FDA) regulations, prescription drug ads cannot be false or misleading, cannot omit facts that are material to representations made in the advertisement, and must have "fair balance" in the presentation of risks and benefits.³ DTC ads in print formats must include information in "brief summary" about side effects, contraindications, and effectiveness.⁴ This requirement is often met by including the complete risk-related sections of the FDA-approved professional product labeling, which is generally intended for physicians, pharmacists, nurses, and other health care professionals.⁵

Broadcast DTC ads have somewhat different requirements. Those ads that mention the name and use of a specific drug and have efficacy and safety claims—called product-specific ads—must include a "major statement" of chief adverse effects and contraindications.⁶ These ads must also include either the brief summary or "adequate provision" for dissemination of the drug’s approved product labeling.⁷

In a guidance finalized in 1999, the FDA suggested that broadcast DTC ads could meet the "adequate provision" requirement by referring consumers to physicians and pharmacists and to more detailed product information available through a Web site, a toll-free telephone number, and a concurrently running DTC print ad.⁸ The guidance also stated that "consumer-friendly language" should be used to present information on indications and the major statement of chief adverse effects and contraindications.

In 2002 an estimated 6,000 pieces of promotional material aimed at consumers were submitted to the FDA, including 486 broadcast ads.⁹ FDA approval of materials prior to dissemination is generally not required; ads are submitted for approval as they go out to the public.¹⁰ In practice, a majority of companies voluntarily submit draft broadcast ads to reduce the likelihood of later enforcement action.¹¹ Although advertisers are not obligated to follow FDA advice regarding draft submissions, this gives the FDA influence over content prior to dissemination.

Given the volume of submitted material, the FDA concentrates on pieces such as television ads and widely circulated print ads.¹² Upon finding that an ad violates regulations, the FDA sends a regulatory letter to the company. Only a small percentage of advertisements have been so cited. The FDA has yet to employ more severe remedies, such as initiating court action to seize products for which there is false or misleading advertising.¹³

DTC advertising controversy. DTC advertising is the subject of intense debate. Proponents argue that it can educate consumers about new treatments, increase treatment for underdiagnosed conditions, and help patients make better-informed health care decisions.¹⁴ Opponents contend that it could interfere with the physician-patient relationship; raise health care costs; and increase consumption of new, more costly products over older, cheaper, and safer alternatives.¹⁵ Opponents also argue that DTC ads oversimplify complex issues and may confuse consumers who lack specialized medical knowledge.¹⁶

Three Studies Of DTC Advertising

Top Three Studies Of DTC... Policy Implications Recommendations Conclusions Editor's Notes NOTES

 
FDA regulations allow broadcast DTC advertisements with incomplete risk information if the ads meet the adequate provision requirement. This raises a number of important questions, including whether consumers can understand the brief risk presentations included in broadcast DTC ads and the more complete information found in supplemental text materials. These questions are of particular importance for adults with limited literacy.

With colleagues Lawren Daltroy and Rima Rudd, we addressed these questions with a series of three studies. We summarize these studies below, followed by a discussion of policy implications.

Content analysis of television ads. We conducted a descriptive content analysis of twenty-three product-specific DTC television ads, focusing on how information was presented.¹⁷ The ads were broadcast on one of the three major network affiliates in Boston, in February or March 2001. The twenty-three ads were for twenty-two different indications.

We observed that the ads gave an average of 30 percent fewer benefit facts per second than risk facts per second. Eighty-three percent of the ads presented risk information in one continuous segment, rather than interspersing the information throughout the ad. During the presentation of risk information, only positive or neutral visual images were shown; images were never negative. Most ads (91 percent) did not use techniques such as changes in speed, tone, or volume to distinguish the risk information from the rest of the ad.

Seventy percent of the ads used both medical and lay terms to convey medical ideas, and 70 percent did not provide any information about risk factors or symptoms that might raise awareness among undiagnosed people. Only 34 percent informed consumers that the drug might not work for everyone.

More than four-fifths of the ads told consumers to talk to their doctors about the advertised drug, but only one ad directed consumers to seek information about the portrayed indication. References to additional sources of product information (such as Web sites, print ads, and toll-free numbers) were presented exclusively in text, usually without explaining what would be found there.

Consumers’ comprehension of television ads. We also directly assessed comprehension of DTC television ads among a sample of adults with limited literacy.¹⁸ We selected three DTC television ads from the content analysis sample: Nasacort AQ (for allergies), Singulair (for asthma), and Zocor (for high cholesterol). We conducted individual interviews with fifty adults recruited from adult education centers in Massachusetts. After viewing each ad, participants answered a series of orally administered true/false questions focused on key content. At the end of the interview, participants answered sociodemographic and health-related questions. The measure of health literacy was the Rapid Estimate of Adult Literacy in Medicine (REALM), which assesses ability to read and pronounce sixty-six common medical and health-related terms.¹⁹

Participants correctly answered an average of 59 percent of the true/false questions. A multivariate analysis showed that the odds of a correct answer were lower for risk information than other types of information (odds ratio =0.28, 95 percent confidence interval: 0.20, 0.40) and lower if the information had been given in text, with or without accompanying audio, rather than in audio only (OR =0.64, 95 percent CI: 0.44, 0.93), controlling for place of birth, literacy level, health status, family history, the ad to which the question referred, and the order in which the ad was shown.

Reading difficulty of text materials. In our third study we examined the supplemental sources of information cited in the twenty-three television ads from the content analysis—in each case, a DTC magazine ad, a Web site, and a brochure obtained through a toll-free number.²⁰ We used the SMOG readability formula to estimate the reading difficulty of the materials.²¹ We also applied the Suitability Assessment of Materials (SAM) instrument to examine specific features that might contribute to reading difficulty.²² The SAM includes twenty-two variables organized into six categories: content, literacy demand, graphics, layout and typography, learning stimulation and motivation, and cultural appropriateness. We assessed the required brief summary section separately from the main body of the material.

All of the materials except one had SMOG scores for both the main body and brief summary sections that exceeded the maximum eighth-grade reading level recommended for materials used with the general public.²³ College-level reading ability would be needed to read the average brief summary section.

The SAM results indicated specific features of the materials that increased reading difficulty, including (1) presentation of extensive information not essential for consumers (for example, pharmacokinetic data); (2) lack of key idea summaries; (3) use of passive voice, complex sentence structure, and technical vocabulary; (4) lack of illustrations for key ideas; (5) lack of visual and typographic cues to highlight key content; (6) use of small type, long line lengths, and crowded layout; and (7) presentation of text without subdivisions.

Policy Implications

Top Three Studies Of DTC... Policy Implications Recommendations Conclusions Editor's Notes NOTES

 
Television ads. Fair balance. Our content analysis suggested several reasons to question whether DTC television ads provide balance in the presentation of risks and benefits. First, the ads gave consumers about 30 percent less time to absorb facts about risks than about benefits. Clearly, fair balance cannot be achieved if statements about benefits are more fully explicated than those about risks.

Second, we observed that some risk statements lacked important contextual information. For example, with a statement such as "Tell your doctor what other medications you are taking," a consumer might not know the unspoken contextual message that other medications could interact with the advertised drug and cause adverse effects. Such assumed background knowledge might be particularly problematic with consumers who have limited literacy.²⁴ The FDA has reported that it monitors DTC advertising to ensure that adequate contextual and risk information is presented in understandable language, but consumers’ limited background knowledge must be considered in this assessment.²⁵

Third, most of the ads presented risk information in one continuous segment. FDA studies show that consumers perceive ads in which risk information is given in one continuous segment by a different announcer as emphasizing risks to a lesser extent than ads in which that information is interspersed.²⁶ The impact of having the same announcer present risk information in one continuous segment has not been studied. Benefit information is typically interspersed throughout DTC ads.

Fourth, closer examination of the visual images shown during the risk segment is also warranted. An ad with contradictory visual and audio messages that minimizes risk information compared with benefit information fails to provide fair balance.²⁷

Our study assessing comprehension of DTC television ads among adults with limited literacy showed that the ads were less successful in communicating risk information than other information, which is consistent with previous research.²⁸ Our content analysis suggests reasons why comprehension of risk information might be lower, but additional research is needed to evaluate the effects of specific ad features.

Consumer-friendly language. An additional concern arises from our finding that a majority of the DTC television ads used some medical vocabulary. Consumers’ understanding of medical terms should not be assumed, particularly among people with limited literacy.²⁹ Use of medical terminology should be carefully scrutinized to ensure that it does not obscure key information.

Adequate provision. Our research also has implications for the adequate-provision requirement. We found that in the television ads, complete references to supplemental information sources were presented exclusively in text. This may be problematic for many consumers, including those with low literacy. Importantly, a previous study found limited recall of sources of additional information cited in DTC television ads.³⁰

Research indicates that relatively few consumers are using supplemental text information sources.³¹ In one study, consumers who had looked for more information as a result of a DTC ad seldom consulted toll-free numbers (15 percent), the Internet (38 percent), or magazines (18 percent), but 89 percent consulted a physician. These consumers most often reported looking for side-effect information.³² More research is needed to investigate whether low consumer recall of the availability of these sources explains their limited use or if other factors are involved.

Text materials. The adequate-provision requirement is meant to ensure that consumers have access to detailed product information, particularly the risk information that is incompletely presented in television DTC ads. However, our assessment of these written materials suggested that they are too difficult to be used by the general public. The average reading difficulty scores of the materials were well above the reading ability of the average adult American.³³

The brief summary sections containing detailed risk information were often particularly difficult. Some of these sections included many unexplained medical terms and extensive clinical research data drawn directly from the approved professional labeling. The FDA has recognized that such information might be difficult for consumers to understand and recently suggested alternatives, such as FDA-approved patient labeling that addresses a drug’s most serious and common risks.³⁴ The FDA recognizes that information intended for consumers should optimally be communicated in language understandable to lay readers and presented in easily readable formats, but the agency only encourages such approaches and does not require them.³⁵

Recommendations

Top Three Studies Of DTC... Policy Implications Recommendations Conclusions Editor's Notes NOTES

 
Based on our analysis, we have developed recommendations for DTC television ads and supplemental sources of information. Improving ads’ educational quality will increase their usefulness to consumers and better meet the spirit of the FDA regulations. These recommendations can be implemented through either voluntary agreements or additional FDA regulations.

Balance risk and benefit information more effectively in television ads. Many different aspects of information presentation should be considered: (1) how fully explicated benefit statements are, compared with risk statements; (2) whether presentation of risk information in a single continuous segment gives the information less prominence than the more interspersed benefit information; (3) whether visual images shown during the risk presentation reinforce benefit rather than risk messages; and (4) whether more difficult vocabulary is used for risk statements than for benefit statements.

Always use consumer-friendly language. As stated by the FDA, it is particularly important that indications and risk information be provided in simple language.³⁶ Ads directed at consumers should use lay terminology wherever possible. If medical terms must be used, they should be defined or examples provided. The background knowledge and vocabulary of consumers with limited literacy should be taken into account.

Sources of additional information should be given in both audio and visual channels. This step is necessary to ensure that consumers, especially those with limited literacy, can find additional information. The ads should also state what information consumers could find in these sources.

Text materials should be prepared according to "plain language" guidelines. These materials should have a reading difficulty score no higher than the reading level of the average adult American—about eighth grade.³⁷ Other plain language guidelines include the following: (1) present only essential information; (2) summarize key ideas; (3) use the active voice, simple sentence structure, and common words and definitions; (4) illustrate key ideas; (5) highlight key content with visual and typographic cues; (6) use at least twelve-point type, short line lengths, and adequate white space; and (7) subdivide the text with headings and subheadings.³⁸ The FDA could outline such guidelines as strategies to make DTC print materials more useful to consumers. Consumers’ understanding of materials with and without such changes should be compared in future research. In addition, our findings indicate that the FDA should require, not simply recommend, the use of consumer-friendly language in DTC print ads, mailed brochures, and Web sites.

DTC advertising should provide more information about the portrayed indication. If the purpose of DTC advertising is to educate consumers and increase treatment for underdiagnosed conditions, as claimed by the pharmaceutical industry, then DTC ads should provide information about symptoms and risk factors. Our findings are consistent with a prior content analysis of DTC magazine advertisements, which showed that few advertisements provided information about causes, risk factors, and prevalence of conditions or clarified common misconceptions.³⁹ DTC advertisements should also provide information on the efficacy of the drug, alternative treatments, and nonpharmacological approaches.⁴⁰

Continued research is needed to evaluate consumers’ comprehension of DTC advertising. Several studies have assessed topics that consumers remember being included in DTC ads, but few have directly tested what consumers actually recall and comprehend.⁴¹ Studies testing comprehension of both print and broadcast ads are needed. Such studies should include participants with a range of literacy skills. Further research should explore how confusion about risk information affects consumers’ attitudes and perceptions of risk. Future studies should also evaluate specific ad features that affect consumers’ comprehension of risk information.

Require prior approval of ads. The current post hoc review of advertisements allows for widespread communication of potentially misleading information. A 2002 report by the U.S. General Accounting Office (GAO) indicated a number of problems with the current system.⁴² First, the FDA cannot verify that it receives all newly disseminated ads from drug companies. Second, a policy change requiring legal review of regulatory letters has increased the time it takes to issue the letters, which can extend consumers’ exposure to misleading ads before the FDA takes regulatory action. This is particularly problematic because the number of FDA enforcement actions against false or misleading ads continued to decline in 2003, while enforcement delays increased.⁴³ Furthermore, while drug companies have complied with FDA requests to stop dissemination of misleading DTC ads, some companies have made misleading claims in subsequent ads. Requiring approval prior to dissemination can help to ensure that misleading information does not reach consumers.

Conclusions

Top Three Studies Of DTC... Policy Implications Recommendations Conclusions Editor's Notes NOTES

 
The results of our research suggest that consumers would have a difficult time learning risk information from DTC television ads and the supplemental text materials linked to those ads. Our recommendations for improving the educational quality of DTC advertising are intended for policymakers, reviewers, and advertisers, as well as for researchers, health care providers, and consumer advocacy groups interested in monitoring DTC advertising.

A central question remains, however: Can DTC advertising truly educate consumers? Some have argued that drug makers are well poised to provide educational information about prescription drugs because of their greater resources and incentive to advertise.⁴⁴ Critics have countered that such education is too important to be relegated to promotions intended to sell pharmaceutical products.⁴⁵

As a first step, we recommend that drug companies implement our proposed policy changes, either voluntarily or through revised FDA regulations. If consumers continue to be exposed to misleading or confusing ads, then we propose the development of alternative, neutral sources of information that could compare different pharmacological and nonpharmacological treatments. In the end, governments and third-party payers might need to work with the medical and public health communities to provide consumers with the information they need to make truly educated decisions.

Editor's Notes

Top Three Studies Of DTC... Policy Implications Recommendations Conclusions Editor's Notes NOTES

 
Kim Kaphingst (Kimberly_Kaphingst{at}dfci.harvard.edu) is a postdoctoral fellow at the Dana-Farber Cancer Institute in Boston, Massachusetts, and a research associate in the Department of Society, Human Development, and Health at the Harvard School of Public Health. Bill DeJong is a professor in the Department of Social and Behavioral Sciences at the Boston University School of Public Health.

This research was supported by the National Center for the Study of Adult Learning and Literacy, funded by Educational Research Development Center Program Award no. R309B002, as administered by the Office of Educational Research and Improvement. The authors thank Lawren Daltroy and Rima Rudd for their valuable contributions to the research studies.

NOTES

Top Three Studies Of DTC... Policy Implications Recommendations Conclusions Editor's Notes NOTES

 

1. J.C. Schommer, W.R. Doucette, and B.H. Mehta, "Rote Learning after Exposure to a Direct-to-Consumer Television Advertisement for a Prescription Drug," Clinical Therapeutics 20, no. 3 (1998): 617–632[CrossRef][ISI][Medline]; and U.S. General Accounting Office, Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations, Pub. no. GAO-03-177 (Washington: GAO, 2002).
2. R.G. Frank et al., Trends in Direct-to-Consumer Advertising of Prescription Drugs (Menlo Park, Calif.: Henry J. Kaiser Family Foundation, 2002); and GAO, Prescription Drugs.
3. M. Baylor-Henry and N.A. Drezin, "Regulation of Prescription Drug Promotion: Direct-to-Consumer Advertising," Clinical Therapeutics 20, Supp. C (1998): C86–C95; T. Nordenberg, "Direct to You: TV Drug Ads That Make Sense," FDA Consumer 32, no. 1 (1998): 7–10; and GAO, Prescription Drugs.
4. D.A. Kessler and W.L. Pines, "The Federal Regulation of Prescription Drug Advertising and Promotion," Journal of the American Medical Association 264, no. 18 (1990): 2409–2415[Abstract]; and U.S. Food and Drug Administration, "Frequently Asked Questions (FAQs)," 28 May 2003, www.fda.gov/cder/ddmac/FAQS.htm (26 March 2004).
5. L.R. Bradley and J.M. Zito, "Direct-to-Consumer Prescription Drug Advertising," Medical Care 35, no. 1 (1997): 86–92[CrossRef][ISI][Medline]; Nordenberg, "Direct to You"; and FDA, "Draft Guidance for Industry—Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements," January 2004, www.fda.gov/cder/guidance/5669dft.pdf (19 April 2004).
6. C.R. Talley, "Direct-to-Consumer Prescription Drug Advertising," American Journal of Health-System Pharmacy 54, no. 19 (1997): 2181; and Baylor-Henry and Drezin, "Regulation of Prescription Drug Promotion."
7. Bradley and Zito, "Direct-to-Consumer Prescription Drug Advertising"; and Nordenberg, "Direct to You."
8. Talley, "Direct-to-Consumer Prescription Drug Advertising"; and FDA, "Guidance for Industry: Consumer-Directed Broadcast Advertisements," August 1999, www.fda.gov/cder/guidance/1804fnl.pdf (19 April 2004).
9. Janet Woodcock, director, FDA Center for Drug Evaluation and Research, statement before the Senate Special Committee on Aging, 22 July 2003, www.fda.gov/ola/2003/AdvertisingofPrescriptionDrugs0722.html (19 April 2004).
10. Ibid.; and M.T. Gahart et al., "Examining the FDA’s Oversight of Direct-to-Consumer Advertising," Health Affairs, 12 February 2003, content.healthaffairs.org/cgi/content/abstract/hlthaff.w3.120 (19 April 2004).
11. Statement by Janet Woodcock.
12. GAO, Prescription Drugs; and Gahart et al., "Examining the FDA’s Oversight."
13. GAO, Prescription Drugs.
14. A. Masson and P.H. Rubin, "Matching Prescription Drugs and Consumers," New England Journal of Medicine 313, no. 8 (1985): 513–515[ISI][Medline]; J. Whyte, "Direct Consumer Advertising of Prescription Drugs," Journal of the American Medical Association 268, no. 25 (1993): 146, 150; Bradley and Zito, "Direct-to-Consumer Prescription Drug Advertising"; A.F. Holmer, "Direct-to-Consumer Prescription Drug Advertising Builds Bridges between Patients and Physicians," Journal of the American Medical Association 281, no. 4 (1999): 380–382[Free Full Text]; and T.V. Terzian, "Direct-to-Consumer Prescription Drug Advertising," American Journal of Law and Medicine 25, no. 1 (1999): 149–167.
15. E. ’t Hoen, "Direct-to-Consumer Advertising: For Better Profits or for Better Health," American Journal of Health-System Pharmacy 55, no. 6 (1998): 594–597; J.R. Hoffman and M. Wilkes, "Direct to Consumer Advertising of Prescription Drugs: An Idea Whose Time Should Not Come," British Medical Journal 318, no. 7194 (1999): 1301–1302[Free Full Text]; and M.S. Wilkes, R.A. Bell, and R.L. Kravitz, "Direct-to-Consumer Prescription Drug Advertising: Trends, Impact, and Implications," Health Affairs 19, no. 2 (2000): 110–128.[Abstract]
16. Committee on Drugs, "Prescription Drug Advertising Direct to the Consumer," Pediatrics 88, no. 1 (1991): 174–175[Abstract/Free Full Text]; Bradley and Zito, "Direct-to-Consumer Prescription Drug Advertising"; and Terzian, "Direct-to-Consumer Prescription Drug Advertising."
17. K.A. Kaphingst et al., "A Content Analysis of Direct-to-Consumer Television Prescription Drug Advertisements," Journal of Health Communication (forthcoming); and K.A. Kaphingst, Examining the Educational Potential of Direct-to-Consumer Prescription Drug Advertising (Boston: Harvard School of Public Health, 2002).
18. K.A. Kaphingst et al., "Comprehension of Information in Direct-to-Consumer Television Prescription Drug Advertisements among Adults with Limited Literacy" (Unpublished paper, Harvard School of Public Health, 2004); and Kaphingst, Examining the Educational Potential.
19. T.C. Davis et al., "Rapid Estimate of Adult Literacy in Medicine: A Shortened Screening Instrument," Family Medicine 25, no. 6 (1993): 391–395.[Medline]
20. K.A. Kaphingst et al., "Literacy Demands of Product Information Intended to Supplement Television Direct-to-Consumer Prescription Drug Advertisements," Patient Education and Counseling (forthcoming); and Kaphingst, Examining the Educational Potential.
21. G. McLaughlin, "SMOG Grading—A New Readability Formula," Journal of Reading 12, no. 8 (1969): 639–646.
22. C.C. Doak, L.G. Doak, and J.H. Root, Teaching Patients with Low Literacy Skills (Philadelphia: J.B. Lippincott Company, 1996).
23. J. Root and S. Stableford, "Easy-to-Read Consumer Communications: A Missing Link in Medicaid Managed Care," Journal of Health Politics, Policy and Law 24, no. 1 (1999): 1–26.
24. D.W. Baker et al., "Inadequate Functional Health Literacy" (letter), Journal of the American Medical Association 275, no. 11 (1996): 840.[CrossRef][ISI][Medline]
25. Nancy M. Ostrove, deputy director, Division of Drug Marketing, Advertising, and Communications, FDA Center for Drug Evaluation and Research, statement before the Senate Subcommittee on Consumer Affairs, Foreign Commerce, and Tourism, 24 July 2001, www.fda.gov/ola/2001/drugpromo0724.html (26 March 2004).
26. L.A. Morris et al., "Consumer Attitudes about Advertisements for Medicinal Drugs," Social Science and Medicine 22, no. 6 (1986): 629–638.
27. K.N. Reeves, "Direct-to-Consumer Broadcast Advertising: Empowering the Consumer or Manipulating a Vulnerable Population?" Food and Drug Law Journal 53, no. 4 (1998): 661–679.[ISI][Medline]
28. Henry J. Kaiser Family Foundation, Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising (Menlo Park, Calif.: Kaiser Family Foundation, 2001).
29. Baker et al., "Inadequate Functional Health Literacy"; E.J. Mayeaux et al., "Improving Patient Education for Patients with Low Literacy Skills," American Family Physician 53, no. 1 (1996): 205–211[ISI][Medline]; and A.E. Cunningham and K.E. Stanovich, "What Reading Does for the Mind," American Educator 22, nos. 1–2 (1998): 8–15.
30. Kaiser Family Foundation, Understanding the Effects.
31. Prevention Magazine, "Fifth Annual Survey: Consumer Reaction to DTC Advertising of Prescription Medicines" (Emmaus, Pa.: Rodale Inc., 2002).
32. K.J. Aikin, "Direct-to-Consumer Advertising of Prescription Drugs: Patient Survey Results," 19 September 2002, www.fda.gov/cder/ddmac/presentations/kitHMCC2002out/index.htm (20 April 2004).
33. Doak et al., Teaching Patients with Low Literacy Skills.
34. FDA, "Draft Guidance for Industry: Brief Summary."
35. Ibid.
36. FDA, "Guidance for Industry: Consumer-Directed Broadcast Advertisements."
37. Root and Stableford, "Easy-to-Read Consumer Communications."
38. Doak et al., Teaching Patients with Low Literacy Skills.
39. R.A. Bell, M.S. Wilkes, and R.L. Kravitz, "The Educational Value of Consumer-Targeted Prescription Drug Print Advertising," Journal of Family Practice 49, no. 12 (2000): 1092–1098.
40. Wilkes et al., "Direct-to-Consumer Prescription Drug Advertising."
41. Aikin, "Direct-to-Consumer Advertising of Prescription Drugs"; and Kaiser Family Foundation, Understanding the Effects.
42. GAO, Prescription Drugs.
43. U.S. House of Representatives, Committee on Government Reform—Minority Staff, "FDA Enforcement Actions against False and Misleading Prescription Drug Advertisements Declined in 2003," January 2004, www.house.gov/reform/min/inves_prescrip/index_drug_ads_2003.htm (13 February 2004).
44. R.W. Dubois, "Pharmaceutical Promotion: Don’t Throw the Baby Out with the Bathwater," Health Affairs, 26 February 2003, content.healthaffairs.org/cgi/content/abstract/hlthaff.w3.96 (20 April 2004).
45. B. Mintzes, Blurring the Boundaries: New Trends in Drug Promotion, 1998, www.haiweb.org/pubs/blurring/blurring.intro.html (26 March 2004); S.M. Wolfe, "Direct-to-Consumer Advertising—Education or Emotion Promotion?" New England Journal of Medicine 346, no. 7 (2002): 524–526[Free Full Text]; and J. Avorn, "Advertising and Prescription Drugs: Promotion, Education, and the Public’s Health," Health Affairs, 21 April 2003, content.healthaffairs.org/cgi/content/abstract/hlthaff.w3.104 (20 April 2004).

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