By Merlin Goldman, Ph.D., M.B.A.

For decades, prescription drug makers promoted their products exclusively to healthcare professionals who were expected to interpret drug information for their patients. But about 15 years ago, partly because of the increase in the number of patients making their own healthcare decisions, some manufacturers began to produce ads targeted to consumers. More than five years after FDA set rules governing this advertising, the marketing of prescription medications directly to consumers remains the focus of considerable debate. However, direct-to-consumer advertising (DTCA) is now established as one of a range of popular promotional tools used by pharmaceutical manufacturers:

• Sampling (55% of spending) is the free drug samples that pharmaceutical representatives provide to office-based physicians. Samples are also being made available through DTCA venues like TV, newspapers, and the Internet.
• Detailing (29% of spending) is the sales activities of drug representatives directed toward physicians.
• DTCA (14% of spending) includes advertisements targeted toward consumers through magazines, newspapers, television, radio, and outdoor advertising.
• Medical journal advertising (2% of spending) is the value of professional journal advertisements.

FDA oversees the advertising of prescription drug products under the Federal Food, Drug, and Cosmetic Act and related regulations. That means the agency must ensure that prescription drug information provided by drug firms is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both health professionals and consumers. There are 3 types of prescription drug advertisements aimed at the public:

• 1. product claim advertisements, which include both the product name and specific therapeutic claims;
• 2. reminder advertisements, which provide the name of a product without stating its use; and
• 3. help-seeking advertisements, which inform consumers of new but unspecified treatment options for diseases or conditions.

All 3 forms of advertising are permitted in the U.S. The advertising of prescription drugs directed at patients is only allowed in the U.S. and New Zealand. On the rationale that such advertising provides important information to consumers and patients who may benefit from advertised products, pharmaceutical manufacturers have campaigned in the E.U. and Canada for the relaxing of current regulatory restrictions.

Market Impact
U.S. spending on DTCA grew rapidly during the 1990s, reaching $2.47 billion in 2000. The dramatic increase in investment by the U.S. pharmaceutical industry is evidence of an expected effect on sales according to Mintzes et al. (BMJ. 2002;324:278-279) who studied the influence of DTCA and patients' requests on prescribing decisions. They found that patients requested prescriptions in 12% of surveyed visits and of these requests, 42% were for products advertised to consumers. In response, physicians prescribed the requested drugs to 9% of patients and requested advertised drugs to 4% of patients. The prescribing rate was similar for advertised and non-advertised drugs (about 74%), but, importantly, patients who requested a prescription were more likely to receive one.
Another study by researchers at Harvard and M.I.T. found that, on average, a 10% increase in DTC advertising of drugs within a therapeutic drug class resulted in a 1% increase in sales of the drugs in that class. Applying this result to the 25 largest drug classes in 2000, the study found that every $1 the pharmaceutical industry spent on DTCA in that year yielded an additional $4.20 in drug sales. DTCA was responsible for 12% of the increase in prescription drugs sales, or an additional $2.6 billion, in 2000. DTCA did not appear to affect the relative market share of individual drugs within their drug class. Additional work by Mintzes et al. (CMAJ. 2003;169(5):405-12) found that more advertising led to more requests for advertised medicines and more prescriptions, as shown in Figure 1. If DTCA opens a conversation between patients and physicians, that conversation is highly likely to end with a prescription, often despite physician ambivalence about treatment choice.

Figure 1: Proportion of patients who requested DTCA drugs by the number of listed products they remembered having seen advertised

Doctor-Patient Relationship
The public has certainly become more aware of DTCA in recent years--the percent saying they had seen or heard an ad for a prescription medication grew from 63% in 1997 to 85% in 2002. But 58% agreed strongly that DTC ads make the drugs seem better than they really are. These ads have also altered the consumer-physician relationship. Nearly a third (30%) of adults say they have talked to their doctor about a drug they saw advertised, and 44% of those who talked to their doctor received a prescription for the medication they asked about.
This means that 13% of Americans have received a specific prescription in response to seeing a drug ad. Murray et al. (J Am Board Fam Pract. 2003;16:513-24) found that physicians reported that more than half (56%) of patients who discussed information from DTCA in a visit did so because they wanted a specific intervention, such as a test, change in medication, or specialist referral. The physician deemed 49% of these requests clinically inappropriate. Physicians filled 69% of requests they deemed clinically inappropriate; 39% of physicians perceived DTCA as damaging to the time efficiency of the visit, and 13% saw it as helpful. Thirty-three percent of physicians thought discussing DTCA had improved the doctor-patient relationship; 8% felt it had worsened it. The effect on the relationship was strongly associated with doing what the patient wanted.

Many critics of DCTA site the pressure exerted on physicians as evidence of its permissive influence. While DTCA remains a relatively small part of overall industry promotion, its rapid spending growth in recent years (increasing an average of 28% annually from 1996-2001), frequent presence on television and in magazines, and extensive use in promoting newer, more expensive medications, have attracted the attention of critics who worry that it encourages patients to demand high-cost prescriptions for ailments that could be treated effectively with lower cost options. Patients' requests for medicines are a powerful driver of prescribing decisions. In most cases, physicians prescribed requested medicines but were often ambivalent about the choice of treatment. If physicians prescribe requested drugs despite personal reservations, sales may increase, but appropriateness of prescribing may suffer.

Concerns about the value of opening up the regulatory environment to permit DTCA in the E.U. and Canada are justified according to critics. Proponents argue that DTCA informs consumers about important, treatable health conditions and encourages doctor- patient communication, while critics say that this type of advertising contributes to rising drug costs and leads people to demand unnecessary or inappropriate medications. The Pharmaceutical Research and Manufacturers of America (PhRMA) believe that the purpose of DCTA is to educate consumers about diseases, about the symptoms that may help them identify the diseases, and about the available therapies developed to treat them. Undoubtedly, the progress of DCTA throughout the rest of the world will be watched with interest by all parties.

This update on the impact of direct-to-consumer advertising on patients, doctor-patient relationships, and physicians' prescribing patterns was written by Merlin Goldman, Ph.D., MBA.

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