Felbatol

A Content Analysis of Conditions, Targets, Inducements, and Appeals

BACKGROUND * We conducted a content analysis of consumer-targeted prescription drag advertisements to explore trends in prevalence, shifts in the medical conditions for which drugs are promoted, reliance on financial and nonmonetary inducements, and appeals used to attract public interest.

METHODS * We collected the drag advertisements appearing in 18 consumer magazines from 1989 through 1998. Two judges independently coded each advertisement and placed it in a category pertaining to the target audience, use of inducements, and product benefits (mean [Kappa]=0.93). We employed descriptive statistics, cross-tabulations, and curve estimation procedures.

RESULTS * A total of 320 distinct advertisements were identified, representing 101 brands and 14 medical conditions. New advertisement and brand introductions increased dramatically during this decade. Advertisements for drugs used for dermatologic, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), and obstetric/gynecologic conditions were most common. Almost all of the advertisements were aimed at the potential user of the drug, not third-party intermediaries such as parents and spouses. Although most advertisements were gender-neutral, women were more likely to be exclusively targeted. One eighth of the advertisements offered a monetary incentive (eg, a rebate or money-back guarantee), and one third made an offer of additional information in printed or audio/video form. The most common appeals used were effectiveness, symptom control, innovativeness, and convenience.

CONCLUSIONS * consumer-directed prescription drug advertising has increased dramatically during the past decade. The pharmaceutical industry is turning to this type of advertising to generate interest in its products. Our data may be useful to physicians who want to stay abreast of the treatments that are being directly marketed to their patients.

KEYWORDS * Prescriptions, drug; advertising; direct-to-consumer promotion [non-MESH]. (J Fam Pract 2000; 49:329-335)

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals in the United States is a fast-growing, much-heralded, and important phenomenon. The purpose of this type of advertising is to induce consumers to request prescriptions from their physicians, usually from their primary care physician.[1] The amount of money the pharmaceutical industry spends annually on DTC advertising is expected to quadruple current levels during the next few years and may approach $7.5 billion by 2005.[2,3] Regulatory oversight of this form of advertising has been the responsibility of the US Food and Drug Administration (FDA) since 1962.[4] Historically, the industry's advertising has been placed in medical journals. However, in the early 1980s several companies began to promote their drugs directly to consumers. The FDA obtained a voluntary moratorium on this type of advertising in 1983, which was then lifted in 1985.[5]

Despite the FDA's green light, the industry did not resume advertising to consumers in earnest until 1990. Regulations have dictated that a DTC advertisement must include a brief summary of indications, side effects, and contraindications.[6] As a result, advertisements were initially placed primarily in magazines and newspapers, because it was difficult to fulfill the brief summary requirement in a broadcast advertisement.[7] This requirement was relaxed in 1997, leading to the recent emergence of DTC advertisements on television.[8]

Members of the medical profession have editorialized on the promise[9,10] and pitfalls[11] of DTC advertising. Disputes have focused on issues such as whether this type of advertising simultaneously informs and influences consumers,[12] enhances or worsens health outcomes,[13,14] leads to the treatment of underserved patients or to an overmedicated society,[15] improves or hurts the physician-patient relationship,[16] and educates or confuses the consumer.[17] We seek to improve the quality of this policy debate through a descriptive analysis of the content of prescription drug promotions that have appeared in popular US magazines from 1989 to 1998.

Our study addresses 4 sets of concerns. First, we examine trends in the breadth of DTC advertising to augment available data on advertising expenditures. We also profile the medical conditions for which advertising has been used, because viewpoints about the appropriateness of DTC promotion sometimes have as their premise assumptions about the seriousness of the conditions for which drugs are advertised.[18] Second, we examine the intended target of these advertisements to better understand the promotional strategies of the drug industry. Third, we describe the inducements offered to readers to promote demand for drugs. Fourth, we document the advertising appeals used to enhance a patient's interest in the drugs, including selling points pertaining to the promoted drug's effectiveness, socialpsychological benefits, safety, and ease of use. In all likelihood, these appeals provide patients with motivation to request prescriptions and with arguments to present to the family physician.

METHODS

Sampling Procedure

Advertisements were collected from 18 diverse magazines. Based on the annual reports of the market research firm CMR, leading American consumer magazines were ranked in terms of the average number of advertising pages sold from 1989 through 1996 (the last year for which data were available at the commencement of our project). The magazines were then stratified according to the classifications reported in Magazines for Libraries.[19] The highest-ranked publication within each of the following 13 categories was selected for inclusion in our sample: business (Business Week), fishing/hunting/guns (Field & Stream), food/wine (Gourmet), home (Better Homes and Gardens), men (GQ), music (Rolling Stone), news and opinion (Time), parenting (Parents), personal finance (Money Magazine), sports (Sports Illustrated), tabloid/general editorial (Reader's Digest), women (Vogue), and medicine/health (Prevention). To these magazines we added 5 publications targeted to narrower segments of the population defined by ethnicity (Ebony and Hispanic), age (Modern Maturity and New Choices for Best Years), and sexual orientation (The Advocate). With the exception of promotions for HIV treatments, which usually appeared in The Advocate, most of the advertisements in these supplemental publications were also found in the primary sample of magazines.

All product-specific prescription drug advertisements appearing in these magazines from January 1989 through December 1998 were photocopied. We excluded disease education messages that did not mention a specific drug and advertisements for medical devices and veterinary drugs. Advertisements for the same brand often differed in nonsubstantive ways and were coded as a single case.(*)

Two judges independently coded each advertisement. To maximize reliability, almost all codes involved a determination of the presence or absence of a word or phrase in the advertisement. The mean kappa across all classifications reported here was .93 (range=0.90-1.0).

Classifications

Medical conditions. We classified each drug brand into 1 of 14 medical condition categories (Table 1). In most cases, this was a straightforward process; however, when a drug was promoted for more than one indication it was classified according to the indication for which it was most extensively advertised.

TABLE 1 An Inventory of Prescreption Drug Brands Advertised in Consumer Magazines, 1989-1998

HIV denotes human immunodeficiency virus; AIDS, acquired immune deficiency syndrome.

Inducements. The advertisements were coded for the presence or absence of an offer of each of the following inducements: patient support services (eg, assistance in helping the reader find a local support group for smoking cessation), additional information about the drug or condition in print or audiotape/video form, and monetary incentives (rebate, discount coupon, money-back guarantee, or free product trial).

Advertising appeals. Each advertisement was coded for the presence or absence of a number of inductively derived claims about the drug's effectiveness, social-psychological benefits, ease of use, and safety. We looked at whether each of 42 adjectives, adjectival phrases, or adverbs was used to describe the drug's nature or impact. We initially coded for the presence or absence of each of these terms or phrases and then collapsed across related claims to create more general product attribute variables as shown in Table 2. For instance, to create the attribute category "Innovative," we coded for the terms "advancement," "breakthrough," "a first," the "only" drug of kind, "innovative," "novel," and "new" and then recoded each advertisement for whether at least one of these descriptors was used to depict the drug.

TABLE 2 Taxonomy of Advertising Appeals

Statistical Analyses

We employed 2 units of analysis. In most instances, the unit of analysis was the advertisement, with descriptive statistics serving as the primary analytic tool. Use of the advertisement as the unit of analysis, however, is inappropriate when inferential tests such as the chi square are used. Doing so would violate the assumption of independence of observations, because most advertisements for a brand represent modifications of previously placed advertisements. We thus relied on the brand as the unit of analysis when using inferential statistical procedures. Specifically, each brand was treated as a single case by giving each advertisement for the brand a weight of 1/n, when n .represents the number of advertisements for that brand. For instance, if 5 advertisements were found for a particular brand, each advertisement was given a weight of 0.2 in these analyses. This approach allows for fractional values on the coded variables. For example, if half the advertisements for a brand provided a monetary incentive, the value for the brand on that variable would be 0.5. Thus, each brand contributed equally to the analyses regardless of the extent to which it was advertised. This is appropriate, because the objective of content analysis is to describe message content, not the effects of that content. In 2 analyses, trends in the frequency with which advertisements and brands were introduced during the decade were examined using the Statistical Package for Social Sciences curve fit procedure.[20]

RESULTS

After aggregating essentially identical advertisements, 320 remained for analysis, covering 101 brands (Table 1). Sixty-eight percent of the brands were oral medications; 17% were topicals or transdermals; 7% required injections; 5% were inhalants; 2% were implants; and one brand (less than 1%) was a suppository.

Trends in DTC Advertising

The first set of research questions pertained to trends in DTC advertising. As shown in Table 1, the most common brands advertised were for dermatologic conditions, HIV/AIDS, cardiovascular disease, and obstetrical/gynecological conditions. Treatments for allergies, gastrointestinal conditions, musculoskeletal ailments, psychiatric/neurologic disorders, and urological conditions were also well represented. Brands for cancer, diabetes, infectious/non-HIV diseases, respiratory conditions, and tobacco addiction were less common.

We examined trends in the breadth of DTC advertising in 2 ways. First, to examine changes in the introduction of new brands, each of the 101 brands was classified under the calendar year in which it first appeared in the sampled publications. These data are reported in the first data series in the Figure, which shows a tendency for new brand introductions to increase during the 10-year period. Although brand introductions leveled off in 1996, the overall trend is best modeled as a linear relationship (adjusted R2=.80; B=2.03; P=.0003). Second, we classified each of the 320 advertisements under the calendar year in which it first appeared. These data are displayed in the second data series in the Figure. The number of new advertisement introductions grew from only 3 in 1989 to 76 in 1998. The best-fitting trend line for this increase is provided by a linear model (adjusted [R.sup.2]=.91; B=7.45; P [is less than] .0001).

[Figure ILLUSTRATION OMITTED]

Target Audiences

Our second set of questions concerned the kinds of consumers to which these advertisements are directed. Approximately 98% of the advertisements were judged as directed at the potential user of the drug; the remaining advertisements were aimed at third-party intermediaries (ie, the parent, spouse, or adult child of the potential patient). With regard to the sex of the targeted reader, 23% of the advertisements (18% of the brands) were judged as directed exclusively at women; 9% of advertisements (10% of the brands) were targeted exclusively to men; and 68% of advertisements (72% of the brands) were directed at both sexes.

Inducements

Our third set of questions addressed the nature of the inducements extended to consumers to encourage demand for the advertised pharmaceuticals. We examined 3 types of: patient support, information, and financial inducements. Patient support services were extended in only 3% of advertisements and 4% of brands.

Readers Were offered additional printed information, such as free brochures or booklets in 34% of the advertisements (39% of brands). Audiotaped or videotaped information was available in 3% of the advertisements (6% of brand). Aggregating across format, 35% of advertisements (39% of brands) offered information in print or audio/video form. Offers of additional information were typically made available to the reader through a toll-free number.'

With regard to monetary incentives, 13% of advertisements (9% of brands) offered a rebate or discount coupon. Only 1% Of the advertisements provided a money-back guarantee; such a guarantee was extended at least once in the advertising campaigns for 3% of the brands. A total of 3% of the advertisements (4% of brands) offered a free sample of the product for the patient trial use. Of course, these inducements were available to patients through prescription only. Aggregating across these 3 monetary incentives, we found that 17% of the advertisements (17% of brands) offered at least one incentive.

Table 3 shows the percentage of advertisements that included patient support offers, information offers (in any format), and financial incentives (of any type) for each of the 14 medical condition categories. Virtually all patient support offers were extended in advertisements for tobacco cessation products.

Information offers were most likely to be found in advertisements for cancer and tobacco addiction but were also common in advertisements for treatments of allergies and conditions of a cardiovascular, dermatologic, obstetric/gynecologic, and urological nature. Monetary inducements were found primarily in advertisements for treatments of allergies, dermatologic problems, and respiratory conditions.

TABLE 3 Percentage of Advertisements Making Each of 3 Types of Inducements, by Medical Condition

HIV denotes human immunodeficiency virus; AIDS, acquired immune deficiency syndrome.

Advertising Appeals

Finally, we examined the nature of appeals used in DTC advertisements. We initially examined the frequency with which each appeal was used across the 320 advertisements. Beginning with the most common appeal, the frequencies were: "effective" (57% of advertisements), "controls symptoms" and "innovative" (41% each), "prevents" condition (16%), "powerful" (9%), "reduced mortality" (7%), "dependable" (4%), and "cures" (3%). The percentage of advertisements using each of the social-psychological benefits claims was: "psychological enhancement" (11%), "lifestyle enhancement" (6%), and "social enhancement" (3%). The ease of use appeals were: "convenience" (38%), "quick acting" (6%), "economical" (5%), and "easy on system" (3%). The safety-related appeals were: "nonmedicated" (14%), "safe" (11%), "natural" (7%), and "not addictive" (5%).

We expected that the use of particular appeals would vary across the medical conditions treated by the promoted drug. Using brand as the unit of analysis, 19 separate cross-tabulations were conducted, one for each appeal listed in Table 2 (therapeutic effectiveness, social-psychological benefits, ease of use, and safety-related), to examine the significance of association between medical condition category and the use of the appeal. Significant associations (P [is less than] .05) between the medical condition classification and appeal use were found for 7 of the appeals, for which adjusted standardized residuals were used to identify sources of significance. We organized these results around the medical condition categories for which an appeal was found to be significantly overrepresented or underrepresented.

Brands for allergy treatments were more likely to claim symptom control (100% of brands vs 41% of the total sample) and treatment without feelings of being medicated (88% vs 9%). Cancer and cardiovascular drugs were more likely to claim prolonged life as a benefit (100% and 20% of brands, respectively) than the total sample (6% of brands). In addition, cardiovascular treatments were more likely to offer economic benefits (40% of brands vs 6% for the entire sample), an effect largely attributable to comparative advertisements focusing on price. Three fourths of brands claiming to offer a powerful treatment fell into the HIV/AIDS category; 55% of those brands made such a claim compared with only 8% for all brands. HIV/AIDS brands were significantly less likely to claim symptom control as a benefit (9% of brands compared with 41% of all brands). Prevention was much more likely to be advanced in promotions for obstetric/gynecologic brands (60%, primarily contraceptives) and respiratory brands (67%) than the sample as a whole (17% of all brands). Respiratory brands were also more likely to claim symptom control as a benefit (100% vs 41% of the sample). Finally, respiratory treatments were more likely to make lifestyle-enhancement claims (67% vs 10% of all brands).

DISCUSSION

The results of our study inform policy discussions on the appropriateness of DTC prescription drug advertising. Although content analyses of drug advertisements appearing in medical journals have been reported, our investigation is the first systematic content analysis of DTC drug advertisements. Similar to previous reports on advertising expenditures, our study reveals that DTC pharmaceutical marketing has increased substantially over the years. Furthermore, DTC advertising has been used to promote drugs for serious conditions; 30% of brands represented in the sample were for such life-threatening conditions as asthma, cancer, cardiovascular disease, diabetes, and HIV infection.

This dramatic increase underscores the need for research on the effects of DTC advertising on drug costs. It is still unclear whether such expenditures are passed on to the consumer through higher prices or promote competition that lowers prices.[21,22] We suspect that advertising-induced increases in demand for a drug may raise costs substantially when alternative treatments are not available or are substantially less effective. Conversely, promotion may spur competition on the basis of price within therapeutic categories when several treatment options are available. Of course, even expensive drugs can lower total health care expenditures if they provide effective treatment for costly conditions.

Although the breadth of prescription treatments advertised to consumers is impressive, the vast majority of drugs have not been promoted in this manner. Clearly, treatments for certain kinds of conditions are more likely to be advertised to consumers. Most of the drugs advertised are for common chronic conditions (approximately three fourths of the brands in Table 1). Drugs for conditions that may not be recognized as pathologic or treatable by consumers (eg, toenail fungus), undertreated ailments (eg, hypertension, depression), and conditions not previously treatable with medication (eg, erectile dysfunction) are also well represented. Advertisements for treatments of acute conditions were rare (eg, antibiotics).

We also investigated the kind of inducements used to promote prescription drugs to consumers. The most common inducement, was the offer of additional information. More than one third of the advertisers extended an invitation to the reader to request further information about the drug or condition in print or audio/video form. DTC advertising has often been justified on the grounds that it offers a valuable opportunity to educate the public about diseases and treatments. Future research should determine if these brochures and tapes provide quality education or simply try to sell the product.

Slightly less than 1 in 5 advertisements offered a monetary incentive to the reader for using the promoted drug. We believe that such incentives may be inappropriate when issued to people who have not had a diagnosis of the indicated condition.[23] These inducements also create the potential for antagonism between the patient who feels denied a bargain and the physician who believes that the drug is not indicated.

Our final objective was to describe the types of appeals used to sell prescription drugs to consumers. This analysis highlights areas in which the industry's advertising requires careful monitoring. We are troubled, for instance, by the finding that two fifths of these advertisements made claims of "innovativeness." Since advertisers often use "new and improved" claims to sell consumer products, it is not surprising that this heuristic phrasing is used to market pharmaceuticals. In truth, when it comes to drugs, what is new is not necessarily better. Most new drugs offer few advantages over older drugs and have less understood safety profiles.

Also of concern is the infrequency with which appeals to cost savings are used. Such appeals were found in only 1 out of every 20 advertisements. The provision of price information, including comparisons of costs with competing drugs, has been mentioned as one mechanism by which price competition could be fostered. We question whether such comparisons would improve the economic and physical health of patients but believe it is disingenuous for proponents of DTC advertising to advance this argument when cost information is seldom provided.

Limitations

Our study has limitations. Most notably, content analysis by its very nature seeks to explicate message form and content, not message effects. Policy discussions must be based on careful analyses of what the drug industry is telling consumers, but such analyses need to be augmented with data that show the effects of DTC advertising on patients' drug information seeking, physicians' prescribing decisions, and ultimately on health outcomes. We also focused exclusively on the text of these advertisements; visual arguments are often used in advertising, including DTC drug advertising.[24] Finally, our sample was restricted to advertisements appearing in US magazines.

CONCLUSIONS

The pharmaceutical industry has turned to consumer-targeted prescription drug advertising to increase Americans' demand for many of its products. If the current trend continues, such advertising could become the major source of information through ,which consumers learn about prescription drugs. As such, it is imperative that family physicians take an occasional look at the magazines in their own offices to keep abreast of the specific drugs being promoted to their patients. If DTC advertising is to be regulated properly, there is much we will need to learn about how these advertisements are influencing consumers and what impact they have on the physician-patient relationship

ACKNOWLEDGMENTS

The authors wish to acknowledge the contributions made by Ronald Emerick, Robert LaGreca, Love Lord, and Sarah Shaw in the collection and coding of advertisements.

(*) Combination rules are available from the authors.

REFERENCES

[1.] Hollon MF. Direct-to-consumer marketing of prescription drugs: creating consumer demand. JAMA 1999; 281:382-4.

[2.] Burton TM, Oho Y. Campaign for Prozac targets consumers. Wall Street Journal July 1, 1997:B1, B6.

[3.] Growth seen in ads for direct-to-consumer drugs. AMA News April 27, 1998:16.

[4.] Drug Amendments of 1962. Pub L No. 87-781, 76 Stat 780 (1962).

[5.] Kessler DA, Pine WI,. The federal regulation of prescription drug advertising and promotion. JAMA 1990; 264:2409-15.

[6.] Bradley LR, Zito JM. Direct-to-consumer prescription drug advertising. Med Care 1997; 35:86-92.

[7.] T'Hoen E. Direct-to-consumer advertising: for better profits or for better health? Am J Health Syst Pharm 1998; 55:594-7.

[8.] Barrett A. Are drug ads a cure-all? Business Week March 30, 1998:59-60.

[9.] Holmer AF. Direct-to-consumer prescription drug advertising builds bridges between patients and physicians. JAMA 1999; 281:380-2.

[10.] Pushing ethical pharmaceuticals direct to the public. Lancet 1998; 351:921.

[11.] Hoffman JR, Wilkes M. Direct to consumer advertising of prescription drugs. BMJ 1999; 318:1301-2.

[12.] Ingram RA. Some comments on direct-to-consumer advertising. J Pharm Marketing Manage 1992; 7:67-74.

[13.] Masson A, Rubin PH. Matching prescription drugs and consumers. N Engl J Med 1985; 313:513-5.

[14.] Keith A. The benefits of pharmaceutical promotion: an economic and health perspective. J Pharm Marketing Manage 1992; 7:121-33.

[15.] Lober CW. Ethics in pharmaceutical advertising. Dermatol Clin 1993; 11:285-8.

[16.] Bell RA, Wilkes MS, Kravitz RL. Advertisement-induced prescription drug requests: patients' anticipated reactions to a physician who refuses. J Fam Pract 1999; 48:446-52.

[17.] Committee on Drugs. Prescription drug advertising direct to the consumer. Pediatrics 1991; 88:174-5.

[18.] Bernstein A. Prescription drugs: pitching directly to the patient. US News & World Report 1990; 108:46-7.

[19.] Katz WA. Magazines for libraries New Providence, NJ: R. R. Bowker; 1997.

[20.] SPSS. SPSS 9.0 regression models. Chicago, Ill: SPSS; 1999.

[21.] Wind Y. Pharmaceutical advertising: a business school perspective. Arch Fam Med 1994; 3:321-3.

[22.] Levy R. The role and value of pharmaceutical marketing. Arch Fam Med 1994; 3:327-32.

[23.] Kessler DA, Rose JL, Temple RJ, Schapiro R, Griffin JP. Therapeutic-class wars: drug promotion in a competitive marketplace. N Engl J Med 1994; 331:1350-3.

[24.] Ferner RE, Scott DK. Whatalotwegot: the messages in drug advertisements. BMJ 1994; 309:1734-8.

* Submitted, revised, December 15, 1999.

From the Department of Communication (R.A.B.) and the Division of General Medicine, Department of Internal Medicine, and the Center for Health Services Research in Primary Care, UC Davis Medical Center (R.L.K.), University of California, Davis; and the School of Medicine, University of California, Los Angeles (M.S.W.). Reprint requests should be addressed to Robert A. Bell, PhD, Department of Communication, University of California, Davis, CA 95616. E-mail: rabell@ucdavis.edu.

ROBERT A. BELL, PHD; RICHARD L. KRAVITZ, MD, MSPH; AND MICHAEL S. WILKES, MD, PHD Davis and Los Angeles, California

COPYRIGHT 2000 Appleton & Lange
COPYRIGHT 2001 Gale Group