Pii: s0140-6736(01)06254-7

Direct-to-consumer advertisements for prescription drugs: whatare Americans being sold? Steven Woloshin, Lisa M Schwartz, Jennifer Tremmel, H Gilbert Welch prescription drug appeared in Reader’s Digest in 1981 billion on direct-to-consumer advertisements for prescription drugs in 1999. Our aim was to establish what advertisements were published, and the US Food and messages are being communicated to the public by these Drugs Administration (FDA) became worried that little was known about the potential effect of suchadvertisements on the public. Consequently, in 1983, Methods We investigated the content of advertisements, the FDA initiated an advertising moratorium while it which appeared in ten magazines in the USA. We examined seven issues of each of these published between July, options.2,3 Although they concluded that “direct to the public prescription advertising was not in thepublic interest,”3 the FDA lifted the moratorium in Findings 67 advertisements appeared a total of 211 times 1985 because of concerns about freedom of speech during our study. Of these, 133 (63%) were for drugs to ameliorate symptoms, 54 (26%) to treat disease, and 23 in place were sufficient to protect the consumer.4 (11%) to prevent illness. In the 67 unique advertisements, promotional techniques used included emotional appeals (45, 67%) and encouragement of consumers to consider medical causes for their experiences (26, 39%). More specifically, that they presented true and balanced advertisements described the benefit of medication with vague, qualitative terms (58, 87%), than with data (9, 13%). However, half the advertisements used data to The FDA monitors compliance with these criteria.
describe side-effects, typically with lists of side-effects that However, prior approval of drug advertisements is not generally occurred infrequently. None mentioned cost.
Reaction to direct-to-consumer advertisements for Interpretation Provision of complete information about the prescription drugs is mixed. Proponents argue that it benefit of prescription drugs in advertisements would serve provides consumers with information about treatment the interests of physicians and the public.
options, and might help to increase public awareness,and consequently treatment, of serious diseases such as diabetes, hypertension, or depression.6 Opponents,however, advertisements might inappropriately increase patientdemand for specific, and generally costly, agents, andthat this demand might have a negative effect onmedical Over the past few years, investment in direct-to- consumer advertising in this field has risen, and nowexceeds US$1·8 billion (figure 1).12 Concurrently,many pharmaceutical companies have reduced theamount which suggests a tactical shift in their focus fromphysicians to patients. Last year, for example, drugcompanies newspapers and popular magazines than they did inmedical respectively) (www.imshealth.com accessed on Aug25, 1999).
VA Outcomes Group, Department of Veterans Affairs Medical physicians has been researched,13–17 but those aimed Center, White River Junction, VT 05009, USA (L M Schwartz MD, at patients has received less attention.18,19 S Woloshin MD, H G Welch MD); Center for the Evaluative Clinical was to establish what messages are being received Sciences, Dartmouth Medical School, Hanover, NH (L M Schwartz, S Woloshin, H G Welch); Norris Cotton Cancer Center, Lebanon, NH (L M Schwartz, S Woloshin); and Department of Medicine, Dartmouth Hitchcock Medical Center, Lebanon, NH American experience might be of relevance in the THE LANCET • Vol 358 • October 6, 2001 For personal use. Only reproduce with permission from The Lancet Publishing Group.
read or understand it.24–26 We entered codes directly into a computer database (FileMaker Pro, version 5.0, SantaClara, CA, USA). The codes allowed us to measure several factors: (1) type of product—we categorised theindications for every medication and then grouped these indications into those intended to ameliorate symptoms,to treat disease, and to prevent disease; (2) descriptionof benefit and side-effects—we noted whether the benefit of the product was described with qualitativelanguage (eg, it works) or with quantitative statements (eg, it lowers the chance of dying by 30%). We codedthe presentation of the product’s side-effects in muchthe same way. We also coded four other aspects of the presentation of benefit: what studies were cited to support this benefit, whether the benefit was compared to that of other similar medications, the use of personal Figure 1: Amount spent by pharmaceutical companies on testimonials about benefit, and whether the widespread use of the drug was mentioned (eg, most prescribed *Television, print, and other. Amount spent in 1999 was projected on the medication); (3) emotional appeal—we coded whether basis of data from first 9 months of the year. the advertisements appealed to the reader’s desire toavoid a feared outcome (ie, cancer or death) or to get back to normal (ie, suggest a return to some normal degree of functioning or being able to do usual daily We selected ten popular magazines with large distribution and varied readership in the USA.23 The advertisements that provided a list of symptoms, or magazines fell into one of three readership categories: suggested that a particular symptom implied a specific those largely read by women (Ͼ70%), by men (Ͼ70%), diagnosis, as encouraging self diagnosis; and finally (5) and by the general population (50% women and 50% cost—we noted whether the cost of the drug was men) (table 1).24 In terms of circulation, every magazine mentioned, whether a free trial was offered, and whether was in the top five in its category. To create a sample a financial rebate was proffered in the advertisement with equal numbers of issues of every magazine, and to Two investigators (SW, JT) independently coded 21 avoid seasonal differences in advertising, we examined elements of the content of every advertisement. Inter- the first issue of every magazine in every other month rater agreement was good for coding the benefit and between July, 1998, and July, 1999. Thus, we assessed potential harms of the drugs (average kappa 0·81).27 As seven issues of every magazine. We found 211 direct-to- expected, kappa was lower for the more subjective consumer advertisements for prescription drugs.
judgments, but remained moderate to substantial (0·52 Recommended international non-proprietary names and for encouraging self diagnosis, and 0·62 and 0·53 for manufacturer details for all drugs mentioned are shown emotional appeals relating to fear and getting back to normal, respectively). Inter-rater agreement was lessthan moderate (<0·4) in only three of the 21 items coded: if the advertisement suggested anyone who cared We identified 67 different advertisements and coded about themselves would use the product, whether the their content. We did not include in our analysis the product was life-enhancing, and the overall focus of the content of the brief summary written in small print on advertisement. To focus on our most reliable findings, the advertisement. This text must be present for the we excluded these three items from analysis. In all other advert to conform with FDA regulations, but is designed instances, wherever the coders disagreed, a third for use by healthcare professionals and few consumers researcher (LS) did an independent assessment. Wethen resolved disagreements by consensus.
We compared the median number of advertisements per issue across the three types of magazines with Kruskal- Wallis tests. This comparison was two-sided and was judged significant at p<0·05. For all analyses we used STATA version 6.0 (College Station, TX, USA).
During the 1 year study, we identified 211 direct-to- consumer pharmaceutical advertisements in 70 issues of selected magazines (median 2.5 advertisements per 42 000 issue, range 0–12). 59 (84%) issues contained at least 42 000 one advertisement. Advertisements for products designed for symptom relief were most frequent (133,63%). Drugs for symptoms of allergies and those related 57 000 to menopause (eg, hot flashes and vaginal dryness) 49 000 accounted for most of the advertisements in this 55 000 category. Those for treatment of urinary incontinence, Table 1: Description of 10 popular magazines studied24 hair loss, Alzheimer’s-related memory loss, erectile THE LANCET • Vol 358 • October 6, 2001 For personal use. Only reproduce with permission from The Lancet Publishing Group.
Oestrogen/medroxyprogesterone Wyeth-Ayerst, St David, PA, USA Boehringer Ingelheim, Ridgefield, CT, USA Symptoms of benign dysfunction, and wrinkles all appeared ten or more hypercholesterolaemia (three Lipitor), and Lyme disease times. Other symptoms targeted included migraines (five), heartburn (five), motion sickness (four), being Figure 2 shows that advertisements appeared more often overweight (three), and bedwetting (one). in magazines targeting women (median 4.5, 25%-75% 3–7) The second most frequently advertised medications were than men (2, 0–3) or a general readership (1, 1–2) those to treat a diagnosed disease (54, 26%), including (p=0·0001). Figure 2 also shows that the advertisements Alzheimer’s (ten Aricept), diabetes mellitus (seven differed by readership category, with advertisements for hair Glucophage, three humalog insulin, and two Rezulin), loss the most popular in men’s magazines and those for HIV-1 (seven Crixivan, one Combivir), otitis media in allergies most popular in the other two categories. children (six Zithromax), depression (four Prozac), fungalinfections (two Lamisil, one Diflucan), arthritis (two Synvisc), and hypertension (one Cardizem CD).
Furthermore, 24 (11%) advertisements promoted drugs as advertisements. Table 2 shows some examples of the preventive medicines, including those for prevention of headlines from 15 advertisements; few explicitly osteoporosis (six Evista), smoking (four Zyban, three described the benefits of a product. Instead, most (58, Nicotrol inhalers), breast cancer (four Nolvadex), 87%) described the benefit of a medication in vague, THE LANCET • Vol 358 • October 6, 2001 For personal use. Only reproduce with permission from The Lancet Publishing Group.
Overactive bladder is a treatable medical condition.
2 Crixivan, HIV disease3 Claritin, allergy Everyday they are learning more about estrogen loss. That's why I'm glad I take my Premarin.
If your heartburn medicine works so well, why do you Is it just forgetfulness . . . or Alzheimer's disease? Why cheat? When now, it's OK to dose and eat! If you are HIV+, Crixivan may help you live a longer, Your son has another bacterial ear infection. He may need an antibiotic, and remember, he has to Cardizem CD and CardiSense may help you live well.
If you're trying to lower your cholesterol, but your numbers still come up high. Ask your doctor for "I got Lyme disease last spring and I'm being treated for serious health problems. I couldn't Figure 2: Direct-to-consumer advertisements for prescription qualitative terms. For example, “Help your child out of If you care about breast cancer, care more about the jungle of allergies”, “Naturally, the response has been positive”, and “If your diabetes is uncontrolled . . .
*Advertisement message that appears in the largest font.
Glucophage can help”. We identified three other Table 2: Headlines of 15 selected advertisements techniques used to imply the benefit of a product: 12(18%) advertisements appealed to the drug’s widespread cited in the Combivir advertisement was published; the use (eg, “more than 1000 000 people have begun using Zyrtec advertisements cited unpublished studies done by Rezulin to help manage diabetes”), 16 (24%) used phrases such as clinically proven, proven relief, or By contrast with details about the benefit of a drug, proven effective, and 8 (12%) used personal testimonials from ordinary people not experts (eg, medication’s side-effects (in compliance with FDA “taking Premarin is something I do for myself every day” and “John wanted to tell you about Accolate for asthma . . . but he’s off to the park”). quantitative data about their frequency. Statements Even when the benefit was explicit, only nine (13%) of typically consisted of a list of side-effects, some qualitative the advertisements actually provided any evidence to judgment about their frequency or severity, and a support their claims. Advertisements for two products, comparison of the occurrence of side-effects with the drug Propecia and Detrol, presented absolute rates of the and the placebo (or sugar pills). For example, “[Side- relevant clinical outcomes for patients taking the drug effects] which occurred about as often as they did with compared with those on placebo, thereby allowing the placebo. Most common were headache occurring in 12% readers to judge for themselves whether the product of people, drowsiness 8%” and “Like all prescription works. None of the other advertisements provided such products, Propecia may cause side effects. A very small complete or balanced information. For example, an number of men experienced certain side effects, such as: advertisement for Renova provided rates for various less desire for sex, difficulty in achieving an erection, and a outcomes for patients on the drug, but did not provide decrease in the amount of semen. Each of these side effects occurred in less than 2% of men”.
advertisement for Diflucan presented data that suggested 45 (67%) advertisements made one of two emotional that the drug was as effective as one of its competitors appeals to readers. The most common appeal (40, (Monistat), but did not define what clinical cure means.
60%) was to the desire to get back to normal (eg, “a Furthermore, advertisements for Prempro and Lipitor pill that helps men with erectile dysfunction respond presented only relative risk reductions (in hip or wrist again”). Less frequent, were advertisements (5, 7%) fractures and cholesterol concentrations, respectively) that focused on a feared outcome (eg, “if you care without specifying the base rate—a presentation format about breast cancer, care more about being a 1·7 than a 36B”). 26 (39%) advertisements encouraged advertisement for Lipitor told readers by what proportion their LDL cholesterol might fall, but never mentioned experiences. These messages ranged from symptom that it was unknown at the time of the advertisement whether Lipitor reduced rates of myocardial infarction or bladder) to the labelling of a specific symptom. Typical death from myocardial infarction. Additionally, an statements encouraging self-diagnosis were: “Is it just advertisement for Crixivan quoted data on intermediate forgetfulness, or is it Alzheimer’s?”, and “If your endpoints only (HIV-1 viral load) despite its focus on a heartburn is persistent and occurs on 2 or more days a long life. Finally, three advertisements (two for Zyrtec and week, you probably don’t have ordinary heartburn. You one for Combivir) referenced studies that appeared in the may have a potentially serious condition called acid text in a footnote. These advertisements did not, however, reflux disease (also known as gastroesophageal reflux provide any data from the studies cited. Only the study THE LANCET • Vol 358 • October 6, 2001 For personal use. Only reproduce with permission from The Lancet Publishing Group.
None of the advertisements mentioned cost, two expenditures increased by almost 19% from 1998 to (Imitrex and Nasonex) offered free trials, and 16 (24%) 1999. Prescriptions for the top 25 drugs directly offered a rebate of some sort ($5 for Claritin, Zyban, marketed to consumers rose by 34% during this time, Flomax, Flonase, Nasocort, Zomig; $10 for Renova; compared with 5·1% for all other prescription drugs.32 Direct-to-consumer advertisements for prescription drugs undoubtedly help to educate consumers about available options. At the same time they encourage The results of our study suggest that direct-to-consumer consumers to believe that a problem might exist (where advertisements are common in popular magazines, they previously would not) and that a pharmacological particularly in those aimed at women. Furthermore, solution is the appropriate way to deal with it. These they all share a similar structure: they link the advertised characteristics are shared by advertisements for over- product with its target condition and invite consumers the-counter drugs. What is unique in this case, however, to share in their own health management. Although is that consumers are also being asked to see their most advertisements addressed the relief of common doctor. Does consumer drug advertising therefore symptoms that many consumers would normally treat promote the medicalisation of an ordinary experience? themselves with over-the-counter remedies (eg, runny Our findings suggest that most prescription drugs nose), a substantial number targeted more complex advertised to consumers target common symptoms (eg, treatment decisions usually made by physicians (eg, sneezing, hair loss, being overweight), which many choice of antibiotic or type of insulin). Additionally, patients would have managed without a physician.
many of the advertisements presented quantitative data Although a pharmacological approach might be about potential side-effects, but very few provided any appropriate for some, the danger is that by turning ordinary experiences into diagnoses—by designating a Our study had three limitations. First, we only looked runny nose as allergic rhinitis—the boundaries of at popular magazines, and did not assess television, medicine might become unreasonably broad. That the radio, or newspaper advertisements. Our results might advertised medications require a prescription have differed for advertisements in these other media.
automatically validates the process of medicalisation. If We chose to focus on magazine advertisements for you have to see the doctor to get a prescription, the several reasons. Logistically, the systematic sampling experience is officially recognised as a symptom of and analysis of such advertisements is easier than with disease, and the affected person is now a patient. In those that are broadcast. For example, whereas there addition to the difficulties of labelling,33 this process can might be much discussion about which phrase stood out result in harm, by exposure of people to medication in a radio spot, there was no ambiguity about the side-effects and by starting other medical processes in headline for a magazine advertisement, which was motion (ie, testing). When the symptoms being treated simply defined as the words with the largest font.
are obvious to patients, and they do not need a doctor to Consequently, we believe that our results are more ascertain whether the medication helped, the problem of reliable than they would have been had we examined medicalisation could be mitigated by reclassification of other media. Moreover, several studies suggest that many prescription drugs to over-the counter status.
magazines provide the most effective format for direct- Our results indicate that few advertisements present to-consumer advertising, since consumers find any quantitative data to support claims of benefit.
advertisements for prescription drugs in magazines the Findings of a study by Moynihan and colleagues34 most memorable and are more likely to ask physicians suggest that news media coverage about medications about products advertised in magazines than in other also frequently lacked information about benefit.
Although the lack of detail is less of a concern for Second, content analysis involves subjective products intended to ameliorate symptoms, since judgments. We tried to make our study as reproducible patients are reasonably well positioned to judge the as possible through development of an explicit coding medication’s effectiveness after a brief trial, it is a major instrument to characterise the advertisements.
concern for those products meant to treat established Furthermore, two authors independently coded the disease, such as diabetes, or prevent them. Because the advertisements, and we restricted our analyses to relevant outcomes (eg, end-stage renal disease, characteristics for which inter-rater agreement had a development of cancer, myocardial infarction, or dying) are rare and occur in the distant future, patients have no Finally, we do not know to what extent consumers way to judge a medication’s effectiveness for themselves.
were actually affected by the advertisements. However, The judgment instead requires quantitative data we do know that pharmaceutical advertisements in obtained from randomised trials and, ideally, informed general succeed in reaching consumers. In a nationally representative survey,31 two thirds of adult Americans To address this difficulty, the FDA might consider a recalled seeing a prescription advertised, and about 10% standardised presentation of benefits and side-effects in asked their doctor for that prescription (of these, 73% advertisements. The format might be one with which said the prescription was made). In another survey,29 consumers are already familiar—ie, a prescription facts about 70% of respondents said that they had seen at box similar to the nutrition facts box required on food least one prescription drug advertisement in the past products.35 Although the precise structure would require 3 months (on average, respondents reported seeing input from many sources, three basic areas might be five such advertisements in that time frame). Results addressed. First, is the setting. This section would of a study of physicians31 showed that about 80% of address the questions: What illness is this medication dermatologists, cardiologists, internists, and for? and who should consider taking it? Second, what is obstetricians or gynaecologists, and 97% of allergists, the potential benefit? This section would include a reported that patients had requested at least one brand standard presentation of data (preferably absolute event name medication. Sales figures also suggest that direct- rates) for both treatment and control groups. Clinical to-consumer advertisements work. Total US drug endpoints would be required (or explicit statements that THE LANCET • Vol 358 • October 6, 2001 For personal use. Only reproduce with permission from The Lancet Publishing Group.
clinical endpoints are unknown). Finally, what are the 10 Lipsky M, Taylor C. The opinions and experiences of family potential harms? These should be prioritised. For physicians regarding direct-to-consumer advertising. J Fam Pract example, side-effects might be separated into life- 1997; 45: 495–99.
threatening and less serious, and might only list the two 11 Wilkes MS, Bell RA, Kravitz RL. Direct-to-consumer prescription drug advertising: trends, impact, and implications. Health Aff 2000; most frequent (or bothersome) side-effects in each 19: 110–28.
category. For new drugs, a special warning should alert 12 IMS HEALTH report. US Pharmaceutical promotional spending patients that FDA approval is based on limited data, and reached record $13.9 billion in 1999: direct-to-consumer spending that the most compelling evidence of safety is a drug’s up 40 percent year-over-year, to $1.8 billion.
track record over time. The recall of Propulsid, Rezulin, www.imshealth.com/public/structure/dispcontent/1,2779,1000–1000–75077,00.html (accessed on March 21, 2001).
and Baycol, three heavily advertised drugs, should serve 13 Lexchin J, Holbrook A. Methodologic quality and relevance of to temper the public’s enthusiasm about new references in pharmaceutical advertisements in a Canadian medical journal. Can Med Assoc J 1994; 151: 47–54.
Consumers are increasingly exposed to direct-to- 14 Herxheimer A, Lundborg CS, Westerholm B. Advertisements for consumer advertisements for prescription products. In medicines in leading medical journals in 18 countries: a 12-month turn, physicians are increasingly confronted with survey of information content and standards. Int J Health Serv 1993;
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content of direct-to-consumer advertisements. Our 16 Stryer D, Bero L. Characteristics of materials distributed by drug findings indicate that these advertisements rarely companies: an evaluation of appropriateness. J Gen Intern Med 1996;
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quantify a medication’s expected benefit, and instead 17 Hueston WJ, Mainous AG. A comparison of the numbers of make an emotional appeal. This strategy probably leaves pharmaceutical advertising pages in family medicine research many readers with the perception that the drug’s benefit journals and journals in other medical disciplines. Acad Med 1997; is large and that everyone who uses the drug will enjoy 72: 804–06.
the benefit. In view of the fact that FDA standards focus 18 Bell RA, Wilkes MS, Kravitz RL. The educational value of on truth and balance, but do not address whether or consumer-targeted prescription drug print advertising. J Fam Pract
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how data should be presented, our results are not 19 Anon. Drug advertising: is this good medicine? Consumer Reports surprising. The provision of complete information about 1996; 61: 62–63.
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21 Ferriman A. Selling drugs to consumers. BMJ 1999; 319: 1208.
Steven Woloshin and Lisa Schwartz conceived and designed the study, 22 Timmins N. GP’s plan talks on drug adverts. Financial Times, July coordinated data collection, created the coding instrument, coded 20, 200: 2.
advertisements, did statistical analyses, interpreted results, and wrote Mediamark research magazine total audiences report (M1) the report. They are the joint first authors of the paper and the order of their names is arbitrary. Jennifer Tremmel helped create the coding 24 Anon. Pushing ethical pharmaceuticals direct to the public. Lancet instrument, coded advertisements, interpreted data, and edited the 1998; 351: 921.
manuscript. H Gilbert Welch helped to design the study, do analyses, 25 Anon. Comments of the staff of the Bureau of Consumer Protection interpret results, and was closely involved in writing the report.
and the Bureau of Economics of the Federal Trade Commission inthe matter of Direct-to-Consumer Promotion; Public Hearing SW and LMS are supported by Veterans Affairs Career DevelopmentAwards in Health Services Research and Development, by a New 26 Hoffman J, Wilkes M. Direct to consumer advertising of Investigator Award from the Department of Defense Breast Cancer prescription drugs. BMJ 1999; 318: 1301–02.
Research Program (DAMD17–96–MM-6712), and a grant from the 27 Landis R, Koch G. The measurement of observer agreement for National Cancer Institute (CA9 1052–01). The views expressed herein categorical data. Biometrics 1977; 33: 159–74.
do not necessarily represent those of the Department of Veterans Affairs 28 Hux J, Naylor C. Communicating the benefits of chronic preventive therapy: does the format of efficacy data determine
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Source: http://vaoutcomes.net/papers/DTC_ads.pdf