A Dangerous Sales Pitch? Hawking Drugs Directly to Patients
It's a routine-looking magazine ad: a smiling young woman, surrounded by flowers, gazes out past the camera. Below her the headline reads "Feel like yourself again," and several paragraphs of copy tell readers about the product that has apparently helped this happy woman do just that.But it is an ad that could not have existed just 16 years ago. Why? Because the product advertised, an allergy medication called Zyrtec, is available only by prescription, yet the advertisement -- in a recent issue of Parade, the magazine that comes with some 37 million Sunday newspapers -- is directed at consumers, not physicians.These "direct-to-consumer" ads for prescription drugs have become so common in recent years that it seems hard to believe they didn't even exist until 1980. Back then there seemed to be no point in hawking such medicines to consumers: only a doctor could prescribe them, after all, and it was assumed that lay people lacked the knowledge and medical background needed to interpret advertising for these powerful and sometimes dangerous drugs.Many consumer advocacy groups still feel that way and sharply criticize the new ads. For example, Dr. Sidney Wolfe, director of the consumer group Public Citizen, argues for a complete moratorium on prescription-drug advertising until the Food and Drug Administration devises new regulations. But the flood tide of direct-to-consumer marketing continues to grow despite the opposition. According to Competitive Media Reporting, a New York marketing research firm, the amount spent on direct- to-consumer prescription-drug advertising rose from $35 million in 1987 to $357 million in 1995. For just the first six months of 1996 the figure topped $323 million. If that pace continues throughout the year, prescription drugs will leap onto the list of top 20 advertised product categories, surpassing tobacco products ($504 million in 1995) and soaps/cleaners/polishes ($596 million in 1995).A glance at the Sept. 22 Parade tells the story even more dramatically: the 32-page magazine contains more than seven pages of prescription-drug ads, far more than for any other type of product.Clearly the pharmaceutical industry is convinced this form of advertising works, and research suggests they are right. Anthony Cox, associate professor of marketing at the University of Indiana School of Business, cites a 1995 survey in which 93 percent of doctors reported that some patients had requested drugs by name -- a sharp increase over previous years.In marketing terms this is what is known as a "pull strategy," Cox explains. Advertising gets potential users to ask doctors for a product, "pulling" it through the distribution chain. The strategy may be an attempt to counter the growing influence of managed-care plans, which often require doctors to prescribe from limited formularies. "Drug companies are spending a lot more attention trying to get on formularies," Cox said, and direct-to-consumer ads are one way of generating pressure from consumers to add specific drugs.But does that pressure come at the expense of patients' health? Some think it does, including Julie Zito, Ph.D., associate professor of pharmacy practice and science at the University of Maryland in Baltimore. Zito helped draft the resolution calling for closer FDA scrutiny of direct-to-consumer prescription-drug ads; the resolution was adopted last year by the American Public Health Association.There are "serious downsides" to these ads, Zito argues, especially when marketers move out of such relatively mild realms as allergy relief and hawk drugs for more complex and life-threatening problems like seizure disorders and AIDS. In an article soon to be published in the journal Medical Care, Zito and Lynette R. Bradley argue, "Fundamentally, the principles of marketing are not synonymous with patient education, despite the adoption of this rationale as a justification by pharmaceutical firms. When consumers are faced with a complex technology that is beyond their formal education, limited information may lead to confusion and heightened expectations about a medication and result in demands for inappropriate treatment or an unnecessary risk." Further, such ads "may promote unnecessary drug consumption by consumers and foster naive expectations that there is a 'pill for every ill.' "Martin Delaney, founding director of the AIDS-treatment information and advocacy group Project Inform, agrees. "The people who read [these ads] have no idea if they need [the drugs] or if it's the right product for them or what the drug interactions are, etc.," he said. "I'm speaking as one who believes big-time in patient empowerment, but I don't believe marketing departments create patient empowerment."Not surprisingly, the industry disagrees. Jeffrey Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers Association, argues against increased regulation of direct-to- consumer ads because "it's a matter of free speech. Pharmaceutical companies are conveying important information, information the consumer should have. It makes the consumer a more knowledgeable person."BREAKING THE TABOOWhen the first direct-to-consumer ads appeared in 1980, the Food and Drug Administration, which regulates all prescription-drug advertising, on the theory that such advertising constitutes an extension of product labelling, was not pleased. The agency asked for and received a voluntary moratorium on such ads, and it stayed in place until 1985. FDA Commissioner Dr. Arthur Hull Hayes was quoted in a 1988 New England Journal of Medicine article as saying that "direct-to- consumer prescription advertising was not in the public interest."What the agency did not do, however, was impose any specific rules or guidelines governing the content of the ads. Instead, it concluded that existing rules -- written to regulate ads directed at doctors and other health professionals -- were sufficient. In recent years the agency has begun to revisit the question, but it appears to be nowhere near making any changes.In the late '80s the regulatory atmosphere began to thaw. According to University of Kentucky professor of pharmacy Joseph L. Fink III, an industry that had lived in fear that pitching prescription drugs to consumers would prompt a government crackdown "began to get signals from the FDA that it was OK." Soon, with no formal change in rules or procedures, the floodgate was open.Nancy Ostrove, public health analyst at the FDA's Division of Drug Marketing and Advertising, acknowledges that the agency has softened its stand somewhat. "We've realized it's not necessarily an inherently bad thing," she said. "It depends on how it's implemented."There, of course, is the rub. And plenty of people are questioning whether the FDA is doing enough to make sure drug advertising is being implemented properly.The agency's rules for prescription-drug ads stem from two key requirements. The first, "fair balance," calls for the description of a drug's potential side effects or dangers to be given equal weight with the descriptions of its benefits. The second requirement is that ads must include directions for use of the product and a "brief summary" of contraindications, warnings, and precautions.But because the rules were drafted to regulate materials directed at doctors, there is no requirement that the disclosures in prescription-drug ads be written in language ordinary people can comprehend. The industry has usually met the "brief summary" requirement by reproducing substantial sections of any given drug's FDA-approved labelling, known as the "package insert" and written in language so technical as to be impenetrable to the nonscientist.The result is a mass of tiny type, usually adjacent to the body of the ad. (Because of this requirement broadcast ads are usually just bare-bones reminders that a product is available; the disclosure requirement applies only if an ad makes claims about a drug's benefits.) The Zyrtec ad, for example, informs readers that potential side effects include tachycardia, hypertension, hyperkinesia, myelitis, and ulcerative stomatitis; that the drug is classed in "pregnancy category B"; and that it was found "nonteratogenic in mice, rats, and rabbits." Technically accurate as such disclosures may be, many consumer advocates argue that they are useless to the average person.Critics also question whether the FDA has enough staff to enforce even the current rules. Though the agency does not review ads in advance, it is charged with reviewing all drug advertising after it appears. Public Citizen's Wolfe thinks the agency is in over its head. "They do not have adequate resources to police the much simpler area of advertising to physicians," he said -- much less the far more difficult, and rapidly expanding, area of direct-to-consumer advertising.A graduate student of Zito's who interned at the FDA last summer came away with same impression, reporting to the professor that "they do not have the manpower they need."According to Ostrove, the agency has 10 staffers who review all advertising and promotional materials for prescription drugs. When asked if 10 was enough, Ostrove became diplomatically vague: "Well, it's better than the four we used to have. Is it enough to do everything we're asked to do? I'd better not take an agency stand."ACCURATE -- BUT MISLEADING?A major concern of critics of direct-to-consumer prescription-drug ads is that advertisements may be truthful in a technical sense but may be misleading to consumers who lack the specialized knowledge necessary to evaluate the information.Project Inform's Delaney cites Hoffmann LaRoche's ads for its anti-HIV drug, Invirase, as a prime example. The ads, which have appeared in the gay press and in magazines such as POZ, which is directed at HIV-positive readers, feature dramatic graphics the depict the drug blocking the HIV enzyme known as protease. The ads tout Invirase (also known as saquinavir) as "the first HIV protease inhibitor."This is accurate, Delaney acknowledges, as is the ad's detailed description of the drug's mode of action. But, he argues, "it tells you nothing about the qualitative value of the drug" -- specifically, that Invirase is by far the weakest of the three protease inhibitors now available. And there is some concern -- though research has not yielded a definitive answer yet -- that using Invirase before using the other protease drugs may help breed HIV that is more resistant to those drugs.Hoffmann LaRoche, Delaney argues, is "riding on the reputation of protease inhibitors," which have gotten much press in recent months, in a way that is misleading and potentially dangerous. "It's the weakest of the drugs, but it's the most heavily promoted," he said. "It just shouldn't be done this way."Laurent Fischer, MD, Hoffmann LaRoche medical director for HIV products, notes that the company has used the same Invirase ad in both consumer and professional publications, though a new consumer-specific ad will debut shortly. "I don't think it is misleading," he said, adding that "it certainly doesn't say it is superior [to the other protease inhibitors]."According to Ostrove, the FDA's current rules don't allow it to require inclusion of the sort of information Delaney would like to see in Hoffmann LaRoche's ads, because official product labelling does not compare drugs.And not everyone is as worried as Delaney is about the dangers of potentially confusing or misleading drug ads. "The important thing to bear in mind is that consumers do not have unfettered access to these drugs," Professor Fink said. "They still must see somebody with a license to prescribe them."But a slowly growing chorus of voices agrees that with the volume of direct-to-consumer ads exploding, the FDA has some catching up to do. The agency began that process with a public hearing last year, but it has no firm timetable for action. "The agency is hoping to do this as quickly as possible," Ostrove said, "but it has a lot of things on its plate."The biggest thing on the FDA's plate, of course, is its effort to step up regulation of tobacco advertising. Fink believes that issue is taking up so much of the FDA's resources that "just about everything else is on hold" for now.In the meantime, Zito and others say, consumers should approach these advertisements with a healthy dose of caution. The drugs that are promoted most heavily, after all, tend to be new, high-profit products that the company may be anxious to sell but that may or may not be right for any individual patient. Consumers need to seek out objective sources of information and develop a strong, open, communicative relationship with their doctor."People may assume that someone has checked these ads, but right now the burden is on the public," Zito warned. "We don't have a whole cadre of Ralph Naders out there."