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Journal of Clinical Oncology, Vol 25, No 10 (April 1), 2007: pp. 1267-1271 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.09.5968 Direct-to-Consumer Advertising in Oncology: A Content Analysis of Print Media
From the Center for Outcomes and Policy Research, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA; and the Fred Hutchinson Cancer Research Center, Seattle, WA Address reprint requests to Jane C. Weeks, MD, MSc, Center for Outcomes and Policy Research, Department of Medical Oncology, Dana-Farber Cancer Institute, 44 Binney St, Smith 271, Boston, MA 02115; e-mail: jane_weeks{at}dfci.harvard.edu
Purpose Content analysis of cancer-related direct-to-consumer advertising (DTCA), with a focus on how benefit and risk/adverse effect information is presented, is essential to understanding its potential impact on oncology outcomes.
Methods We reviewed all oncology DTCA appearing in three patient-focused cancer magazines and a sample of selected popular magazines from January 2003 to June 2006. We determined the Flesch reading ease score (FRES) for the text in each advertisement (a score Results Of 284 advertisements identified, 49 were unique. Oncology-related DTCA was rare in the popular magazines, and appeared mostly in those aimed at female readership. About equal amounts of text were devoted to benefits and risks/adverse effects, and all text was difficult to read. The mean FRES for benefit text was 39.71; for risk/adverse effect text, it was 38.22, a difference of 1.49 (95% CI, –4.02 to 7.00). The largest font size for benefits was 4.60 mm on average; for risks/adverse effects, it was 2.38 mm, a difference of 2.22 mm (95% CI, 1.35 to 3.09). Appeals to medication effectiveness were frequent (95%) and often made with clinical trial data (61%). Conclusion Oncology print DTCA is prevalent in cancer-related, patient-directed magazines, and infrequent in the popular press. The information presented is considerably difficult to read, raising important questions about the appropriateness of direct-to-consumer marketing for oncologic medications.
Direct-to-consumer advertising (DTCA) is a promotional effort by a pharmaceutical company or other provider of medical services to present information about medications or medical services to the public in the lay media.1 Appearing as television, radio, internet, newspaper and magazine advertisements, billboards, and direct mailings, DTCA is becoming more prevalent. In the year 2000, $2.5 billion was spent on advertisements targeting potential patients2; by 2005, spending had increased to $4.2 billion.3 Venues for DTCA of medications are increasing. For example, whereas there was only one nationally distributed patient-directed cancer magazine featuring DTCA in 1996, now there are four. Such is the perceived impact of DTCA on patients and physicians that the American Medical Association recently proposed that the US Food and Drug Administration (FDA) institute a waiting period for direct-to-consumer marketing after a medication's initial approval4; a recent Institute of Medicine report on drug safety proposed the same.5 Indeed, DTCA likely has a significant effect in oncology. For example, a survey of 221 oncology nurse practitioners found that 94% reported a request for a medication by a patient who had seen an advertisement, with 40% experiencing one to five requests per week.6 DTCA may have several benefits. These include educating patients about new medications, perhaps empowering them to seek medical care for undiagnosed conditions, and possibly even facilitating patient-provider communication. For example, advertisements for medications to ameliorate the adverse effects of chemotherapy may prompt patients to discuss their symptoms more openly with providers.7 On the other hand, DTCA can be misleading, and has the potential to undermine a patient's trust in his or her clinician. It may also lead to inappropriate prescriptions, especially in cases in which scientific data about the harm-adjusted benefit of a medication is not conclusive. This may be of particular concern in cancer medicine, where there are currently few highly effective treatments, and adverse effects can be significant. All advertising for medications, including DTCA, is regulated by the FDA. In addition to monitoring false advertising claims, the agency also aims to ensure that advertisements achieve "fair balance"; that is, an evenhanded discussion of benefits as well as risks and adverse effects.8 To this end, all medical advertisements must be submitted to the FDA simultaneously with their appearance in the media; pharmaceutical companies have the option to submit them beforehand, but that is not required. If an advertisement is found to be objectionable, the FDA can issue either an "untitled letter"—which asks the company to simply pull the advertisement—or a "warning letter," which requests a corrective campaign.9 To understand the potential impact of cancer-related DTCA, it is essential to determine how widespread it is, and then investigate how representative advertisements comparatively present a medication's benefits and risks/adverse effects. Building on prior studies that have analyzed general print DTCA,10-13 our objective was to perform a content analysis of oncology print DTCA. We first aimed to determine its prevalence in the popular press as well as in patient-directed magazines. Next, we aimed to assess the advertisements’ readability, with a focus on how the benefit and risk/adverse effect information is presented, as well as several other characteristics that might influence their comprehensibility (such as the size and placement of text). Given the dread associated with cancer diagnoses and the limited effectiveness of many cancer medications, we also aimed to assess the types of advertising appeals (for example, social-psychological v medication effectiveness) that are made in this increasingly prevalent medium of medical communication.
We reviewed all DTCA for oncology-related medications appearing in a sample of 10 popular magazines (first issue available of every January and June) and in every issue of three patient-focused cancer magazines from January of 2003 to June of 2006. The popular publications, a sample of magazines with wide readership in the United States that had been used in a prior content analysis,11 were Gentleman's Quarterly, Men's Health, Sports Illustrated, Better Homes & Gardens, Family Circle, Good Housekeeping, Ladies’ Home Journal, Newsweek, People, and Time. The cancer magazines were identified by contacting the patient libraries at the 19 National Comprehensive Cancer Network member institutions and inquiring as to which patient-focused magazines they regularly received. The top three were CURE, Coping with Cancer, and MAMM: Women, Cancer & Community. Advertisements were selected for analysis based on the following criteria: presented a medication intended to directly treat cancer or to mitigate chemotherapy adverse effects, spanned at least one page, and was either a "reminder" (included the name of the drug without a description of its use) or "product-specific" advertisement (included both the name of the drug and a description of its use).9 "Health-seeking" advertisements, which are sponsored by pharmaceutical companies but include only general disease information without mention of a drug, were excluded. The text of each advertisement was scanned, converted to a Microsoft Word file of continuous text, and proofread for consistency with the original. Benefit and risk/adverse effect assignments were made for the text using two methods. In method 1, each sentence of the advertisement's text was designated as "benefit," "risk/adverse effect," or "neither" according to its specific content. In method 2, a less strict schema, each sentence of the text was designated as "benefit" or "risk/adverse effect" according to its own content or its contribution to other statements about benefits or risk/adverse effects. Text designated as either "benefit" or "risk/adverse effect," according to the two methods described in the preceding paragraph was then grouped and analyzed. We assessed the proportion of total text they each comprised, the text placement (first and/or final third), and the largest font size devoted to each. We then assessed the readability of the two types of text using the two methods of text categorization as described. This analysis was done using Microsoft Word 2000 to determine the Flesch reading ease score, calculated with the formula [206.835 –(1.015 x average sentence length) –(84.6 x average syllables per word)].14 Ranging from 0 to to 100, a Flesch reading ease score of 65 or higher is considered understandable for the average person. We next assessed the nature of the appeals made in each advertisement. An advertisement was considered to include data if it had graphs, charts, or numbers/percentages of patients experiencing an outcome or adverse effect, or if the advertisement mentioned findings from clinical trials. The presence of the image of a celebrity, as well as the presence of an image of an apparent patient or physician was also catalogued. Patient testimonials were considered present if an advertisement contained a picture of an apparent patient with accompanying text suggesting an endorsement from this individual in favor of the medication. Finally, we assessed for the presence of competitor comparisons. We evaluated the content of each advertisement's appeals using the method of Bell, Kravitz, and Wilkes.10 Such appeals include claims about the drug's effectiveness, social-psychological benefits, ease of use, and safety. We determined the presence or absence of Bell and associates’ complete set of 60 terms used to describe a drug's nature or impact, and added 12 others specific for medications intended to treat cancer or to mitigate chemotherapy adverse effects (eg, we added "remission" under the effectiveness category). We also catalogued the presence of Bell et al's common inducements, coding each for offers of the following: patient support services, additional information about the drug or condition, and monetary incentives.
Two judges independently evaluated each advertisement. In all cases in which the judges did not concur, a third judge performed an independent assessment, and disagreements were resolved by consensus. Inter-rater reliability for the two main judges (before resolution by consensus) was assessed on a sample of 15 advertisements (average kappa [
In 136 issues of the selected magazines (56 cancer-related, 80 popular press), we identified 284 cancer-related, direct-to-consumer advertisements. All issues of the patient-directed cancer magazines contained at least one direct-to-consumer advertisement. Cancer-related advertisements were much less prevalent in popular magazines, with predominance in magazines aimed at female readership. No cancer-related direct-to-consumer advertisements were found in any of the men's magazines, although a few were found in the general interest magazines. The advertisements promoted chemotherapy, hormonal agents, targeted therapies, and cancer-related supportive agents such as antiemetics, laxatives, analgesics, and hematopoietic growth factors. We did not find any advertisements for chemotherapy in the popular press (Table 1).
After eliminating duplicates, there were 49 unique advertisements for 22 products. Five of these were reminder advertisements (made no specific appeal), and thus were excluded from benefit versus risk/adverse effect analysis as well as analysis of the nature and content of appeals. The ratio of the amount of text devoted to benefit information versus risk/adverse effect information was close to 1, irrespective of how these were defined (0.87 using method 1, 1.20 using method 2). Benefit information was likely to be present in the first third of text; risk/adverse effect information in the final third. Although the advertisements were hard to read overall, there was only a modest difference in readability between benefit and risk/adverse effect text using the looser definition (method 2). The largest type size devoted to benefit information was, on average, several millimeters larger than the largest type devoted to risk/adverse effect information, irrespective of the definition used (Table 2).
The nature and content of the advertisements’ appeals and the presence of inducements are summarized in Table 3. Clinical trial data were presented in a majority of the advertisements, and most contained an image of a patient. Appeals to medication effectiveness were very frequent. About half of the advertisements made social-psychological appeals—often with the idea of "getting back to normal"—and almost half made appeals to the ease of use of medication, such as infrequent dosing requirements. Almost all the advertisements offered more information, most often through a Web site.
We found that DTCA for oncology medications is common in patient-directed cancer magazines. Oncology-related advertisements are much less prevalent in popular magazines, but when they do appear, they tend to be in magazines that target female readers. Although some of the medications advertised in the popular press are for gender-specific treatments (eg, Arimidex [anastrozole; AstraZeneca, Wilmington, DE] for breast cancer), the majority are for supportive treatments that are appropriate for either sex (eg, Procrit [epoetin alfa; Ortho Biotech, Bridgewater, NJ] for chemotherapy-associated anemia). This predilection on the part of pharmaceutical companies to attempt to influence female consumers may reflect an awareness that women tend to be medical decision makers. In a recent study of 298 outpatients asked to designate a health care agent,15 Lipkin found that those subjects who chose their parent were five times more likely to choose their mother than their father. Those who chose a child chose a daughter three times as often as a son, and those who chose a sibling chose a sister twice as often as a brother. Indeed, a societal perception of females as medical decision makers may also have influenced the creation of the patient-directed cancer magazines: of the four widely-circulated magazines, two (MAMM: Women, Cancer, and Community, and Women and Cancer) focus on women's cancers, and none target malignancies affecting only men. Our finding that oncology-related DTCA is difficult to read overall is consistent with prior studies. For example, a study of the educational content of medication brochures sent to patients by pharmaceutical companies found that only 17% were written at a reading level of eighth grade or lower.16 Moreover, in a content analysis of DTCA from popular magazines, Bell et al found that of 14 disease categories, advertisements for cancer medications were the hardest to understand, providing the least information about the underlying condition (tied with HIV-related advertisements), and having the least educational value.17 On the basis of prior analyses of television and internet advertising,18,19 we had expected that benefit information might be easier to read than risk/adverse effect information. We found instead that all of the information was hard to read. The absence of a clear distinction in readability between the two types of information is reassuring in terms of the FDA's requirement for "fair balance." The overall poor score on readability is more difficult to interpret. On the one hand, these advertisements clearly have minimal educational value. On the other, because they make their arguments and appeals in language that is hard to follow, patients may be more likely to ask providers to explain the information before committing to a decision about whether or not they want to be treated. The poor readability may, thus, ironically act to reinforce the provider's position as the ultimate decision maker. The speculation herein underscores a main limitation of our study: content analysis is limited to assessing the content of media, but cannot determine the media's ultimate effect. It is possible that the poor readability of oncology-related DTCA does not affect consumer behavior at all, or that there are other variables that are more important to the advertisements’ comprehensibility. For example, the type of information itself (benefit v risk/adverse effect) might ameliorate poor readability. Kaphingst et al20 found that subjects answered an average of 59% of comprehension questions about television DTCA correctly. Subjects got fewer answers wrong, however, on questions relating to risk rather than other types of information (odds ratio = 0.28; P < .0001). It is also important to emphasize that readability is only one dimension of the presentation of information that may affect comprehension. We chose items such as readability and font size for their face validity, but we did not analyze other items that may aid comprehension (but are more subjective to evaluate), such as summarizing key ideas, using the active voice, and subdividing text with headings and subheadings.21 Also, although we found that benefits were more likely to be presented earlier than risks/adverse effects, we cannot predict definitively the effect of text placement because we do not know the order in which the advertisements are actually read. The most common appeals made in the oncology DTCA were to medication efficacy (95%). This is possibly an oncology-specific effect, because results from clinical trials are especially influential in determining clinical practice in cancer medicine. In their analysis of 320 advertisements from 18 magazines, Bell et al found significant associations between the condition for which a medication was indicated and the type of appeal made10; for example, oncologic and cardiovascular medications were more likely to claim longer life as a benefit (100% and 20%, respectively) than the total sample (only 6%). In contrast, in her content analysis of DTCA from 24 popular magazines, Pinto22 found that the advertisements employed a mix of appeals ("informational" v "emotional") and that the type of appeal did not vary systematically with the type of medication advertised. In summary, oncology print DTCA is prevalent, is often aimed at female readership, makes frequent appeals to medication efficacy, and is considerably difficult to read. Our results raise important questions about the appropriateness of DTCA for cancer-related products. What makes many oncology providers uncomfortable with DTCA is the suspicion that, rather than representing responsive marketing that is simply "finding and filling needs," current campaigns have evolved into so-called need-shaping marketing, introducing products that "nobody asked for" or could "even conceive of."23 Although such a development would be unfortunate—especially if it results in costly, superfluous, or even harmful treatments—it is not a foregone conclusion. An important next step will be to determine exactly how the characteristics of oncology-related DTCA interact with those of cancer patients and providers to determine outcomes such as medication requests and prescriptions.
The authors indicated no potential conflicts of interest.
Conception and design: Gregory A. Abel, Stephanie J. Lee, Jane C. Weeks Administrative support: Gregory A. Abel, Stephanie J. Lee, Jane C. Weeks Provision of study materials or patients: Gregory A. Abel, Jane C. Weeks Collection and assembly of data: Gregory A. Abel, Jane C. Weeks Data analysis and interpretation: Gregory A. Abel, Stephanie J. Lee, Jane C. Weeks Manuscript writing: Gregory A. Abel, Stephanie J. Lee, Jane C. Weeks Final approval of manuscript: Gregory A. Abel, Stephanie J. Lee, Jane C. Weeks
We thank Marie-Adele Sorel, Harvard Medical School class of 2009, for her assistance with this project.
Supported by a US Department of Health and Human Services Public Health Services Training Grant (G.A.A.). Presented in part at the 42nd Annual Meeting of the American Society of Clinical Onoclogy, June 2-6, 2006, Atlanta, GA. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.
1. Wilkes MS, Bell RA, Kravitz RL: Direct-to-consumer prescription drug advertising: Trends, impact, and implications. Health Aff (Millwood) 19:110-128, 2000[Abstract] 2. Fintor L: Direct-to-consumer marketing: How has it fared? J Natl Cancer Inst 94:329-331, 2002 3. Report to Congressional Requesters: Prescription drugs: Improvement needed in FDA's oversight of direct-to-consumer advertising. Report GAO-07-54, US Government Accountability Office. Washington DC, November 2006, p 13 4. American Medical Association Newsroom, Releases and Statements: AMA calls for temporary moratorium on direct-to-consumer advertising of new prescription drugs. http://www.ama-assn.org/ama/pub/category/16467.html 5. Institute of Medicine Report: The future of drug safety: Promoting and protecting the health of the public. http://www.iom.edu/CMS/3793/26341/37329.aspx 6. Viale PH, Sanchez Yamamoto D: The attitudes and beliefs of oncology nurse practitioners regarding direct-to-consumer advertising of prescription medications. Oncol Nurs Forum 31:777-783, 2004[Medline] 7. Abel GA, Penson RT, Joffe S, et al: Direct-to-consumer advertising in oncology. Oncologist 11:217-226, 2006 8. Lyles A: Direct marketing of pharmaceuticals to consumers. Annu Rev Public Health 23:73-91, 2002[CrossRef][Medline] 9. Berhman RE: Testimony before the Senate Special Committee on Aging. http://aging.senate.gov/public/index.cfm?Fuseaction=Hearings.Detail&HearingID=72 10. Bell RA, Kravitz RL, Wilkes MS: Direct-to-consumer prescription drug advertising, 1989-1998: A content analysis of conditions, targets, inducements and appeals. J Fam Pract 49:329-335, 2000[Medline] 11. Woloshin S, Schwartz LM, Tremmel J, et al: Direct-to-consumer advertisements for prescription drugs: What are Americans being sold? Lancet 358:1141-1146, 2001[CrossRef][Medline] 12. Welch Cline RJ, Young HN: Marketing drugs, marketing health care relationships: A content analysis of visual cues in direct-to-consumer prescription drug advertising. Health Commun 16:131-157, 2004[CrossRef][Medline] 13. Sumpradit N, Ascione FJ, Bagozzi RP: A cross-media content analysis of motivational themes in direct-to-consumer prescription drug advertising. Clin Ther 26:135-154, 2004[CrossRef][Medline] 14. Kincaid JP, Fishburne RP, Rogers RL, et al: Derivation of New Readability Formulas (Automated Reliability Index, Fog Count and Flesch Reading Ease Formula) for Navy Enlisted Personnel. Millington, TN, Naval Air Station, Branch Report, 1975, pp 8-75 15. Lipkin KM: Brief report: Identifying a proxy for health care as part of a routine medical inquiry. J Gen Intern Med 21:1188-1191, 2006[CrossRef][Medline] 16. Chao BA: Evaluating the educational content of direct-to-consumer fulfillment materials. Am J Health Sys Pharm 62:620-625, 2005 17. Bell RA, Wilkes MS, Kravitz RL: The educational value of consumer-targeted prescription drug print advertising. J Fam Pract 49:1092-1098, 2000[Medline] 18. Kaphingtst KA, Dejong W, Rudd RE, et al: A content analysis of direct-to-consumer television prescription drug advertisements. J Health Commun 9:515-528, 2004[CrossRef][Medline] 19. Macias W, Stavchansky Lewis, L: How well do direct-to-consumer DTC, prescription drug websites meet the FDA guidelines and public policy concerns? Health Mark Q 22:45-71, 2005[Medline] 20. Kaphingtst KA, Rudd RE, Dejong W, et al: Comprehension of information in three direct-to-consumer television prescription drug advertisements among adults with limited literacy. J Health Commun 10:609-619, 2005[CrossRef][Medline] 21. Kaphingst KA, Dejong W: The educational potential of direct-to-consumer prescription drug advertising. Health Aff 23:143-150, 2004 22. Pinto MB: On the nature and properties of appeals used in direct-to-consumer advertising of prescription drugs. Psychol Rep 86:597-607, 2000[Medline] 23. Kotler P: Kotler on Marketing. New York, NY, The Free Press, 1999, pp 23-24 Submitted October 17, 2006; accepted December 20, 2006.
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
65 is readable for the average person). We also assessed the proportion, type size, and placement of benefits and risks/adverse effects, as well as the nature and content of advertising appeals. 
] = 0.87). As would be expected, 
