Update on Direct-to-Consumer Advertising of Prescription Drugs

Up ate 0 irect-to-Consumer Advertising of Prescription Drugs by Sophia Feisullin, MBA, and Robert B. Sause, PhD

Advertising prescription drugs to consumers raises concerns about misinterpretation of uses despite promises of a better-educated consumer. irect-to-consumer (DTC) advertising of prescription drugs has been increasing in recent years. Manufacturers face intense competition, and perhaps feel the need to build brand recognition among consumers for prescription drugs that might eventually be converted to nonprescription status. Thus pharmaceutical marketers are no longer relying exclusively on persuasiveness of physician-journal advertising.1 DTC ads are appearing more frequently in both print and broadcast media. The reasons for the growth, as well as the positive and negative effects on both the consumer and the medical community, are varied. The community pharmacist, as the most accessible health care practitioner and recognized "drug expert," can expect to receive many questions from patients regarding the information in these ads. Consequently, pharmacists should be aware of the development and future direction ofDTC ads.

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Early History One of the first experiences with DTC advertising of a prescription drug occurred in England with the product Naprosyn (naproxen), manufactured by Syntex. At the time of its introduction, N aprosyn was a new anti-inflammatory agent used in the treatment of arthritis. The drug had also become the subject of broadcast talk shows where both the benefits and risks of using the drug were discussed. Syntex management soon realized that the drug's intensive but brief exposure to the public had dramatically reduced the length of its introductory stage by accelerating its use by physicians. The product was pushed to a high sales volume in just a few short months. Patients learned of N aprosyn early and their requests apparently turned their physicians into early users.2 In the United States, Merck, Sharp & Dohme (MSD) adopted a public advertising campaign of its

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pre cription drug, Pneumovax, a vaccine for the prevention of pneumococcal di ea e. MSD' adverti ement were unique because they targeted healthy, elderly con umer who were potential user of the vaccine. The Pneumovax experience exemplifie the benefits of DTC ads to both the public and the industry. When healthy elderly consumers remain healthy they are not very likely to visit a physician; thus mass media advertising and wordof-mouth communication were essential for this target group to learn about the vaccine. 2 However, the physician is still in control of product selection. In the United States, an intense advertising campaign by Boots Pharmaceuticals for Rufen (a nonsteroidal anti-inflammatory drug), in which the product was the subject of many talk shows, commercials, and newspaper and magazine ads, did not result in increased prescription sales. Therefore, it seems that higher consumer awareness, stimulating some patients to discuss the product with their physicians, may not be enough to boost sales. 2 In some instances, Food and Drug Administration (FDA) regulations may hinder the ability to advertise a specific drug. For an ad that identifies a prescription drug by name to be placed in a medium directed toward the general public, it must give information about the use of the drug, including all side effects. This, obviously, goes well beyond the limits of a 30- or 60-second broadcast commercial. 3

loday's DlC Ads Ads with no specific reference to a generic or brand-name product have recently become more common. Many of the recent advertisements basically describe a health problem, then name the pharmaceutical company and urge the consumer to visit his or her physician. The Pharmaceutical Manufacturers Association noted that some of its members are choosing to use this type of advertising while others are not. 4 Recently, the research-based drug companies have been chang-

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ing their marketing strategies. For orne companies, the change has been to whom they market. For others, it is how they market. 5 Pharmaceutical companies have found that traditional methods of influencing physicians' choice of drugs are less effective in today's changing environment. Brandname drugs are now being advertised directly to the physician on Lifetime Cable Network. Pharmaceutical companies that once relied on personal sales calls, direct mail, and medical journal ads are now using such marketing techniques as "peer-influence" sessions, interactive computers, and increased promotion to pharmacists and consumers. It is hoped that these techniques will help protect companies from heightened competition,

Pharmaceutical companies that once relied on sales calls, direct mail, and medical journal ads are now using 'peer-influence' sessions, interactive computers, and increased promotion to pharmacists and consumers. rapidly changing medical technology, and shifting responsibility for prescription order fulfillment. 5 elBA-Geigy, Lilly, Marion Merrell Dow, Burroughs-W ellcome, and Pfizer are some of the drug companies that have taken their advertising directly to the consumer in recent years. Some companies have used ads in public service formats that suggest the need for a drug product without mentioning the drug specifically. A Marion Merrell Dow spokesperson indicates physicians would not appreciate consumers coming in and telling the physician the drug products they want. Yet, these ads could also induce people to seek medical help who otherwise would not. For example, statistics show

that only one in four people who have ulcer-related symptoms actually go see a doctor,3 although help is available.

Attitudes Toward DTC Advertising Richard L. Casey, president and chief executive officer of California Biotechnology, believes that there will be a massive swing toward DTC advertising for both ethical and nonprescription medications in the coming years. DTC advertising will become another pharmaceutical marketing tool for reaching physicians as well as other health care professionals and consumers.6 Additionally, the traditional "activity-passivity" model of the practitioner-patient relationship, in which the patient unquestioningly accepts the physician's advice, seems to be changing to a relationship of mutual participation. In the new model, the physician and patient have equal power and, if the relationship is to continue, their behaviors must be mutually satisfying. "Doctor-shopping" research found that as patients become more involved in their health care, they tend to seek physicians who are willing and able to accommodate their desires for increased participation in the process. 2 One study of consumer awareness of DTC advertising found that pharmaceutical ads provide information that consumers want and feel they have a right to know. Consumers believe that the information should come from their physician or pharmacist, but they also believe that the professional may not always be well-informed. 2 These findings suggest that consumers may be willing to act on information they receive through advertising and ask their physician about the drugs advertised. Given the substantial proportion of respondents indicating their intent to discuss specific drug therapy with their physician as a result of seeing a DTC ad, the generally favorable attitudes, and the concern about underinformed health care providers, consumers seem willing to accept this new form of advertising. 2

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DTC ads have been the subject of much controversy and debate within the industry, FDA and other regulatory agencies, and practitioners. Although many are generally positive about DTC advertising, others voice concerns (see table, p. 50).

The Government Congress may perceive prescription drug advertisements as a problem. Worried that consumers will soon regard prescription drugs as just another product they can buy, several congressmen have written the three major Medical studies reveal. .. networks to discourage the The earlier you use Rogaine, use of these commercials. the better your Staff members for the U.S. House committees involved in chances of growing hair. this issue say there are no plans for legislation to change the situation at this time, but any commercial will be watched closely. One reason Congress may be avoiding action is fear that .. any ban on the commercials Send in the coupon or call 1 800 772-0033 ext. 671 would violate the First for your $10 certiJicate. Soon. Amendment. 4 In the past, in:~~~¥~~,~~.i~ ~ formation disseminated in a I ~..;."':'4lJ~~:~~;,,~~~7'~*:';~7~~';~ I commercial context, such as I ~.WI_~~~.::~~;;;!;~~=;;:!'i:::;'~~~ I I '...... I 1'······-··----1 advertising, was considered I..... --- [ 1 (" ."'.;''''__.____ .•.... _ _ _ . _ 1 mercantile and not subject to ...................._.... _ _ " , _ 1 L..::.::.:. __ _ _ ..:.-::...-.J First Amendment protection , -,. as are other forms of expres· §pg~n~ sion. The U.S. Supreme The only product proven to grow hair. Court modified the "mercantile" standard significantly Direct-to-consumer ads, such as the Upjohn when it declared that just beCompany's Rogaine, must include a summary of cause a speech appears in warnings and side effects for the consumer (not commercial form does not shown). deny it First Amendment protection. 7 A citizens' petition submitted to FDA in 1989 argued that the agency did not follow prescribed rulemaking procedures and, therefore, their regulations regarding DTC ads are not legal. The petition states that the 1962 Kefauver Act, on which current regulations are based, was not intended to be applied to consumer advertising of prescription drugs. 8 \\jUR.~Jnt" v.wk for~"

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The Professions A resolution of the American Medical Association disapproved of DTC advertising because this type of promotional effort is viewed as an

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unnecessary health care expenditure. 9 AMA also indicated concern that DTC advertising could confuse and mislead consumers, compromise the physician-patient relationship, lead to demands or requests for medically unnecessary use of drugs, and result in reduced compliance with prescribed drug regimens, particularly by elderly patients.lO The American Pharmaceutical Association, on the other hand, supports regulations that permit companies to use prescription drug advertising that informs patients of conditions the drugs will treat, provided there is no specific reference to a generic or brand name. 4

The Industry Drug manufacturers, however, indicate their consumer-targeted ads are well-received by physicians. For example, the Seldane campaign creates a marketplace for a prescription drug for allergies, which many people would treat with nonprescription products. The DTC ad campaign sends patients to the physician's office.5 One study demonstrates that DTC ads tend not to offend physicians; only 20% of nearly 700 physicians surveyed had negative attitudes about DTC ads. Generally, the negative reaction stemmed from ads that specified a product name, made misleading claims, or stressed cost.1l When MSD introduced its anticholesterol drug Mevacor, it began a cholesterol awareness campaign in Raleigh and Seattle. A spokesperson indicated that the company has maintained all along that it will not get into brand advertising because it interferes with the physician-patient relationship. SmithKline Beecham has gone well beyond this in its campaign for Tagamet, a drug for ulcers. Television commercials on all three networks do not mention their product but urge viewers to "go see your doctor and ask about available treatment programs sponsored by SmithKline Beecham, the ulcer experts."4 What sets the Tagamet program apart is that when a company does this type of advertising, it usually

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owns the market, but in this case there are other H2-receptor antagonists on the market. Both Tagamet and Zantac (from Glaxo) are billion-dollar drugs worldwide. Glaxo is running a similar campaign for its product. 4 Mickey Smith, professor of health care administration at the University of Mississippi, believes that advertising of this kind will be for products that treat widespread conditions, such as ulcer preparations and antihistamines. However, an analysis by the CBS network shows that the drugs most likely to be advertised are those for cardiovascu1ar' antiarthritic, digestive/urinary, respiratory, diabetes, and glaucoma conditions. 4 But Ken Feather, acting director of FDA's drug advertising division, is concerned that an ad may attempt to tell a person whether a diuretic or beta blocker or some other drug is right for a hypertensive patient. Such messages might be appropriate for some conditions, such as hayfever, or antismoking campaigns, but not for something more complicated.12 CBS has been a major force in the effort to bring about DTC advertising of ethical pharmaceuticals by issuing proposals and research on this subject since 1984. The focus of the research is to define what drugs would be appropriately advertised directly to the consumer. This includes drugs used in non-lifethreatening situations-drugs that might eventually be approved for nonprescription sales. 4 Bill Castagnoli, president for North America at D'Arcy Masius Benton & Bowles Index Medicus Unit, advises using non-product-specific consumer campaigns only for ethical drugs that are leaders in their categories and are still on patent, to avoid benefiting the competition. 5 Some drug manufacturers want FDA to allow brand-name advertising on broadcast television. So far, this type of advertising has appeared only on physician-oriented programming on the Lifetime Cable Network. However, many of these firms tend not to want to "rock the boat" in Washington at this point. 4 By viewing drug advertising on

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television, consumers may be highly likely to follow through by requesting specific brand-name products from their physicians or pharmacists. A major problem is that current advertising by prescription drug manufacturers is plagued by low consumer recall of the actual message. Thus, some observers have recommended that advertising should become more like that of other consumer goods, both in frequency and in use of the product name. Relatively high consumer recall, however, was influenced by experience with the affliction involved. 13 FDA's Ken Feather has stated that advertising agencies should not promote prescription products in the same way that they are promoting Chevrolets, dog food, or a political candidate. FDA is trying to educate both ad agencies and manufacturers to focus on the societal aspects of promoting a prescription drug14 (see sidebar, p. 51). FDA recently investigated the extent to which it was possible to convey risk information about prescription products in consumer advertisements. The results indicate that it is possible to communicate this type of information to consumers. There is, however, some evidence of misinterpretation of ad information. Benefit information tends to be recalled more frequently than risk information. 2 Proponents argue that if learning takes place on the part of the consumer, the result could be a more intelligent patient who knows preventive health care measures and methods for proper use ofmedications, and even how to better choose health care providers, protecting oneself from underinformed practitioners. Direct advertising may simply provide consumers with information they desire. 2 FDA's position on this matter has been to neither discourage nor encourage DTC advertising of prescription drugs.1 5 Still, many pharmaceutical industry executives remain skeptical about the feasibility and value of promoting a product to consumers that is prescribed by physicians. Colford et al. contend that it will be

Reasons For and Against the Use of DTC Ads Reasons for Use Rise in generiC substitution Increased competition Need to develop brand loyalty Patients' taking a more active role in their care Better informed patients Both consumers and physicians can be reached directly through the media Existing channels of communication possibly inadequate Reasons Against Use Inappropriate prescribing Increase in brand-name drug prices Increased use of brand-name products Decreased use of generic products Patient confusion Stimulated drug use in an over-medicated society Adapted from Reference 4.

rare when a DTC ad can meet all of FDA's requirements for disclosure of side effects and other warnings. 16 However, recent ads in print (Upjohn's Rogaine, Riker's Minitran, CIBA-Geigy's Estraderm) provide detailed summaries for the consurner. Mary Doug Tyson, a consumer safety officer in FDA's Division of Drug Advertising and Labeling, claims that consumer-directed marketing has not caught on, partially because the so-called ''brief summary" of information that FDA requires for product-specific ads would make advertising in consumer media unfeasibly long and expensive. A Squibb spokesperson comments that a state of flux exists in terms of what approaches FDA and the pharmaceutical industry consider appropriate in communicating to the public. 5

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J. Douglas Archer, advertising manage and associate director of creative services for MSD, has stated that the company wants to determine if it is necessary to run paid health information spots when publicity and public service announcements about high cholesterol may suffice. l l The ads currently aired are similar to public service announcements. CBS, NBC, and several ad agencies are funding a study to determine whether televised brandname prescription-drug advertising is cost-effective. 17 If found to be cost-effective, this type of advertising could grow tremendously.

Some Concerns Clearly, there exists a risk that consumers could be misled through advertising. Deception could occur even if standards are well designed. These are disturbing questions since advertising, by its nature, embellishes strengths and masks weaknesses. FDA and the industry must ensure that this does not happen. Another problem is that it is ex-

pensive to make an impression on a person's consciousness. DTC advertising may reduce competition because of the size of the advertising budgets of the larger versus the smaller pharmaceutical manufacturers. We believe this is unlikely since the amount of advertising that would occur may not be large enough for this to happen. It is also questionable whether any amount of advertising alone can create brand loyalty, especially in the pharmaceutical market. Some opponents fear that direct ads would raise drug prices because these ads will supplement and not replace present advertising expenditures. Some proponents, however, contend that the increase in competition will lower drug prices and promote the use of lower-cost generic equivalents. 2 Another concern is that physicians may be caught off guard. They may be questioned about drugs and therapies with which they are not familiar. On the other hand, this type of advertising may save lives when someone recognizes their symptoms in an adver-

Kessler's FDA Takes Firmer Stance on Advertising Direct-to-consumer advertising of prescription drug products is likely to be much more intensely regulated under David A Kessler, new commissioner of the Food and Drug Administration (FDA). In a break with the FDA approach of the 1980s, Kessler's FDA has become a watchdog, ferreting out advertising or promotional campaigns that mislead or confuse the public. The agency is expected to release regulations on direct-to-consumer ads shortly. In the meantime, Kessler has appointed Ann Witt as the new acting director of the Center for Drug Evaluation & Research Division of Drug Marketing. In an interview with the Pharmaceutical Manufacturers Association (PMA), Witt said PMA companies should prepare "for much more serious penalties. All traditional methods-seizures, injunctions, prosecutions-as well as preclearance" will be considered. Other examples of FDA's tougher stance on advertising include plans to establish a hot line that pharmacists and physicians can call to report "promotional abuses"; the seizure of several food products that make misleading claims on their labels such as "Fresh Choice" orange juice and Ragu "Fresh" Pasta Sauce; and the issuance of warning labels to mouthwash companies that are making the unsubstantiated claim that they reduce plaque and gingivitis. Kessler maintains that advertising plays an important role in educating the public. However, according to an article he co-wrote in the November 17, 1990, issue of the Journal of the American Medical Association, "if a perception develops that the increase in prescription drug advertising and promotion is resulting in inaccurate and misleading information, then more aggressive regulation may result."

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ti ment. The con umer and perhap the phy ician may become more educated about state-of-theart therapies. Advertising in the form of public relations is also a concern, as in the case of Retin-A. Media attention to the research regarding Retin-A's ability to reduce the aging effects associated with sun-damaged skin increased the demand for the drug. Patients came into their doctor's office asking for this drug as a "rejuvenating" cream. Physicians have a wide latitude to recommend approved drugs for whatever use they deem suitable.18 FDA recognizes that any investigator has the right to call a press conference and announce his findings and that the press may decide if they want to report it. However, Feather thinks that free speech on behalf of a commercial interest may differ from other First Amendment protection. It is not acceptable for a company to stage a campaign to promote an unapproved use of a drug; therefore, this type of activity may be viewed in the same way as an ad. 14 However, even with these restrictions it may still be possible to reach the consumer directly. Drug companies have also used well-known public figures to endorse their products. Mickey Mantle has been paid to praise the antiarthritic drug Voltaren on talk shows. 14 These types of endorsements have also been used in advertising Prozac and Oraflex to the public. The requirement for total disclosure of side effects, contraindications, and effectiveness in ads is difficult to meet since it is impossible to simply explain many products currently advertised. The consumer may become confused even when given information about treating relatively simple conditions such as a cold. Perhaps the major question in DTC advertising should not be whether advertising is used, but how an advertising program can be properly developed and executed. Rather than persuade, the goal of such advertising should generally be to inform. Advising consumers about drugs and therapies now

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available can only result in a more educated consumer.

The Role of the Phannacist AI?, a drug expert and advisor to the patient, the phannacist has an obligation to discuss drug therapy with the patient. With the widespread use of DTC advertisements, one may find the patient initiating these discussions with increasing frequency, seeking additional information on an ad either seen on television or in print. In fulfilling his or her professional obligation to advise the patient, the pharmacist must keep in mind, first, the specific needs of the patient and, second, the trust the patient has placed in the physician. The pharmacist must assume that the patient's existing therapy is correct, rational, and appropriate for the patient's current condition. When a patient questions the pharmacist about a specific DTC ad, the pharmacist is often placed in a sensitive situation. In providing useful and correct information to the patient, the pharmacist should not impede the physician-patient relationship. For the pharmacist, each and every patient interaction would be different depending on the individual patient's variables and the circumstances surrounding the patient's need for information. For example, the patient requesting information about the product Seldane may differ significantly from the patient seeking information about Procardia XL (nifedipine) for treating heart conditions. With a drug product like Seldane where most other antihistamines are nonprescription and the drug is used to control symptoms, the pharmacist may feel free to discuss all aspects of the drug. This may be especially true if the patient has already used several antihistamines or antihistamine-decongestant combinations. Providing the patient with all the necessary information, followed by a recommendation to discuss the usefulness of the product with the physician, is certainly appropriate. For questions resulting from DTC advertisements of a product

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like Procardia XL that is used to treat a serious disease for which other alternative forms of therapy are available, the pharmacist needs to understand the basis of the patient's questions. The ad for Procardia XL focuses on those patients already taking Procardia, informing patients that the new form of the drug makes it "easy" to take. The ad is not intended to attract new users to Procardia, but at the same time, it may stimulate patients who see the ad to ask questions. If the patient is already taking a drug for a heart condition, it is assumed that the patient's physician has weighed the various treatment regimens and has decided upon the "best" drug availabl~which is the product the patient is currently taking. To voice an opinion that the drug featured in the DTC ad may be a "better" form of therapy for the condition may impede the trust the patient has placed in the physician. This may not be in the patient's best interest. However, providing information that would stimulate patient-physician dialog in a positive manner seems appropriate. Indicating that a drug product is available and describing how the drug may work, leaving the specifics of the patient's disease state to the physician's discussion with the patient, seems reasonable. As drug therapy continues to improve with newer drug products coming to the marketplace and as the patient becomes more educated, the pharmacist has an even greater challenge and obligation to share his knowledge with the patient. Certainly, DTC ads will affect the relationship between the pharmacist, patient, and physician. It is hoped that patients will become even more acutely aware of the knowledgeable person available to them at their pharmacy.

Acknowledgments The authors would like to thank William R. Good and Michael Kishbauch of CmA-Geigy Corp., and Virginia Galizia of St. John's University for their support and advice.

Sophia Feisullin, MBA, is employed by CIBA·Geigy Corp., Ardsley, N. Y., in the new product development area. Robert B. Sause, PhD, is an associate professor, Department of Pharmacy and Administrative Sciences, College of Pharmacy and Allied Health Professions, St. John's University, Jamaica, N. Y.

References

1. Hiestand M. Sandoz' Rx-drug ad hits newspapers. Ad Week/Marketing Week. September 21, 1987;28:6. 2. Perri M, et aI. An exploratory analysis of consumer recognition of direct-to-consurner advertising of prescription medications. J Health Care Marketing. March 1987;7:9. 3. Koenig R. SmithKline sets TV ads to boost sales of anti-ulcer drug Tagamet. Wall Street J. March 25, 1988; 28. 4. Rosenthal EM. Big ad revenues, big obstacles loom for prescription TV. Television/RadioAge. May 16,1988;35:35. 5. Neiman J. New prescriptions for marketing ethical drugs. Ad Week / Marketing Week. January 4, 1988;29:20. 6. Executive prophecies for the industry in the 21st century. Pharm Exec. February 1990;10:38. 7. Cohen D. Advertising and the First Amendment. J Marketing. July 1978;42:59. 8. The Pink Sheet. FDC Rep. T&G-8; December 4, 1989. 9. Resolution No 93. Adopted by the House of Delegates Proceedings. American Medical Association; June 1989. 10. Letter from James E. Sammons, Executive Vice President, American Medical Association, to Frank E. Young, Commissioner, Food and Drug Administration; October 18, 1985. 11. Winters P. Merck mulling ads for cholesterol drug. Advertising Age. April 11, 1988;59:12. 12. FDA becoming sensitive to anti-generic campaign. Drug Cosmetics Industry. August 1986;139:30. 13. New prescription for drug spots. Television/RadioAge. April 1987;34:63. 14. Feather KR. When is PR promotion? Med Marketing Media. August 1989;24:27. 15. FDA piqued by Lexis remarks. Med Marketing Media. May 1989;24:4. 16. Colford SW, et aI. CBS opens study, FDA nixes drug and review. Advertising Age. December 1987;58:33. 17. Miller A, et aI. Pitching to patients. Newsweek. May 8, 1989;40. 18. Vreeland LN. The selling of Retin-A. Money. April 1989;18:74. 19. Smith Me. Principles of PhaT7'lUlCeutical Marketing. Philadelphia: Lea and Febiger, 1983.

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