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Drug Ads After a Decade: Are Direct to Consumer Messages Still a Good Idea?
By Alan Klein, Donald B. Parks, M.D., and Jenna Evans
Open a magazine today -- virtually any magazine -- and you will find ads for prescription pharmaceuticals. Channel surf your TV and perhaps every fourth or fifth commercial will promote a drug. Pharmaceutical advertising is big business. But have the targets of these ads -- consumers and the only people licensed to prescribe the advertised drugs, their doctors -- benefited from the onslaught of pharma direct-to-consumer advertising (DTCA)?
The issue of direct to consumer marketing is quite complex and one with which doctors grapple on a daily basis. All patients, regardless of their socioeconomic status, are aware of the newest drugs that are advertised on TV, periodicals, sports venues, etc. Thus, doctors are forced to specifically address the pros and cons of medications, and remind patients that sometimes the advertisements they see on television do not adequately reflect the narrow range of patients for whom such drugs may be appropriate. Doctors are trained or learn in practice how to handle DTCA queries from patients.
Beginning in 1997, when the FDA issued new rules to govern DTCA in the drug business, patients were increasingly brought into a conversation that previously had occurred exclusively between drug manufacturers and physicians. With regulations designed to standardize the look and content of drug ads, and the threat of sanctions against manufacturers who fail to comply, the FDA has approved what today seems routine in the patient-physician relationship. How well have these ads served their intended purposes, and what lessons have we learned?
Drug Advertising Is Focused and Expensive
In 2004, pharmaceutical companies spent an estimated $4.15 billion in DTC advertising in both print and broadcast media. These expenditures were used to advertise about 147 of the approximately 50,000 drugs included in the National Drug Code Directory. Of these, the ten most frequently advertised -- Nexium, Crestor, Cialis, Levitra, Zelnorm, Prevacid, Flonase, Singulair, Lipitor, and Plavix -- accounted for over one-third of the total expenditures. Some of the most widely advertised drugs address such important concerns as diabetes, high cholesterol, hypertension, and respiratory illness, not mere "lifestyle" concerns, as critics sometimes contend.
Recently, too, certain pharma manufacturers have begun special advertising campaigns highlighting health concerns without naming specific pharmaceuticals.
Broadening the Patient-Physician Dialogue
In reviewing an impressive volume of articles on DTC advertising from its inception to the present, one is struck by the range and differences of opinion on the subject. Most concede that advertising drugs directly to the public leads to more prescriptions; but it also often results in the treatment of diseases not previously diagnosed. DTCA motivates patients to become more involved in their healthcare decision-making, but it may also create patient confusion regarding whether an advertised drug is appropriate for them. Although many doctors believe that DTCA leads to better discussions with patients about their health and the appropriateness of specific advertised pharmaceuticals, other doctors express concern about misconceptions patients have about these drugs.
Do Drug Ads Lead to Overprescribing?
Nearly half of doctors in one study said they felt pressured to prescribe a drug, even if it's not the advertised drug. In a telephone survey of 3,000 patients and 600 physicians, and an online survey of other patients, nearly three-quarters of the patients responding who discussed an advertised drug during a DTCA-prompted office visit (about a third) were prescribed a drug. For half, the patient received the advertised drug. Half of those who were not prescribed the advertised drug reported that their physicians told them that the advertised drug was not right for them. In other instances, the physician told the patient that a prescription medication was unnecessary or that another drug, or an over-the-counter medication, was more suitable. Other physicians recommended and prescribed a less expensive drug or advised the patient against switching from his or her current drug therapy.
In another study conducted in partnership with Harvard Medical School, among the respondents who had seen or heard a drug ad within the preceding year, one-fifth improved their diets and became more conscientious in taking prescribed medication. The same proportion received a diagnosis for a previously undiagnosed medical condition as a result of a doctor's office visit prompted by DTCA. Among the new diagnoses, over a third were for serious diseases. In this study, among those patients who switched drugs because of the office visit, those who switched to DTC-advertised drugs were more likely than those who switched to non-advertised drugs to report a reduction in the severity of side effects relative to their prior medications.
Do Patients Who Ask About Advertised Drugs Receive Better Care?
Another study appearing in the Journal of the American Medical Association sought to determine the influence of patient requests for medication on the quality of medical care. Researchers conducted a randomized, controlled trial using middle-aged women, most with professional acting experience, to simulate patients with emotional features of depression and an adjustment disorder. The "patients" visited physicians and were trained to request specific advertised medications, or to request medication generally, or to make no request. Doctor notes and written assessments of these office visits were reviewed by physicians in a blinded evaluation to classify medical diagnoses, identify prescribing patterns, and make recommendations for follow up treatment.
Among the findings was that patient requests for medication -- either brand-specific advertised drugs or a generalized request for medication -- resulted in dramatically increased prescribing. However, the quality of medical care for those patients feigning major depression, measured by both initial care and follow up treatment, was significantly better for patients requesting an advertised drug and those making a general request for medication than for patients making no such requests.
Patients Who See a Drug Ad Seek Additional Information
Many of the published papers on DTCA express a concern that physicians may be pressured by patients aggressively seeking a prescription for an advertised drug. In an interesting survey to determine how DTCA affects patient behavior, women college students of child-bearing age were recruited and exposed to a fictitious ad for an oral contraceptive medication. The purpose of the study was to determine whether the cohort, after viewing the advertisements for the drug, were inclined to seek additional information from their physician or to request a prescription for the advertised drug. Over 90% of the participants in the study were more likely to seek information about the drug than a prescription. Only about 4% of the respondents were more likely to seek a prescription than information. The proposed inquiries of the physician by the women participating in the study focused primarily on the effectiveness of the drug, its side effects and appropriateness for the patient.
In an interesting survey designed to determine how the public responds to prescription drug advertising and the extent to which specific ads are likely to encourage people to seek medical treatment or obtain additional information, as well as their effectiveness in communicating information about drug side effects, the Henry J. Kaiser Family Foundation found that by and large drug ads prompt many people to speak with their doctor about advertised drugs. Confirming other studies on the subject, the Foundation also found that a small but significant minority of persons who have seen a drug ad receive prescriptions for the advertised drug as a result of a DTCA-motivated office visit. Those with the greatest health needs -- the elderly and those who report they are in fair to poor health -- are more likely to talk with their doctor about an advertised medicine, although not more likely to receive a prescription for the particular drug.
In analyzing whether drug ads raise awareness of health problems and treatments, or likely side effects, the study showed mixed results. Interestingly, most of those who had seen a drug ad, although not always able to recall specific side effects, were more likely than those who had not viewed the ad to perceive a drug's side effects as "serious."
Consumer Recall of Advertised Drug Benefits and Risks
One of the longest running series of studies of direct-to-consumer drug ads has been the annual surveys conducted since 1998 by Prevention magazine with technical assistance from the FDA's Division of Drug Marketing, Advertising, and Communications (the latest iteration being sponsored by Prevention, Men's Health, and Women's Health). The surveys find that a large percentage of those seeing a drug ad on television, 79%, remember seeing or hearing the risk information, and a slightly smaller percentage 75%, the benefit information. Consumer attention, therefore, appears to be greater for risk information than benefit information; and about 21% of consumers exposed to pharmaceutical television advertising use toll-free phone numbers or access Internet sites identified in the ad to obtain more information about the advertised medicine.
The current Prevention magazine survey found that notwithstanding increasing prescription medicine advertising expenditures by drug companies, the proportion of consumers who talk with their doctors about an advertised drug has remained relatively stable over time, approximately one-third. Fewer, however, now ask their doctor for a prescription for the advertised drug, only 21% in 2005 down from a high of 30% in 2002. Of those requesting a prescription for the advertised pharmaceutical, two-thirds today actually receive a prescription for that drug, down significantly from a high of 84% only a year earlier. More doctors are also prescribing medications other than the advertised drug (21% in 2004 vs. 7% in 2003).
The Role of the Internet in Consumer Awareness of Drug Safety
Seven in ten consumers use the Internet each year to find information about prescription drugs -- or about 41 million consumers. Half of those going online seeking such information spoke with their doctor about the drug, 18% asked for a prescription for the drug, and a little over 40% of those received the medicine (but a little under 60% did not). Twenty-six percent of those patients asking for a specific advertised drug were prescribed another medication, and about a third were not given any prescription at all.
Pharma Regulates Its Own Advertising
The pharmaceutical industry itself is taking significant steps to regulate the content and accuracy of DTCA and ensure the ongoing safety of consumers. Last year, one of the industry's primary trade groups, Pharmaceutical Research and Manufacturers of America, adopted formal guidelines with respect to DTCA. These guidelines, which became effective in January of 2006 and are actually more stringent than similar regulations promulgated by the FDA, seek to ensure accuracy in pharmaceutical advertising and the education of both consumers and health care professionals on drug health and safety issues. Individual companies have also taken steps to encourage customers to make sensible use of DTCA. Last year, for example, Pfizer announced plans that include an effort to educate physicians about new medications prior to doing DTCA and then including language in the DTCA informing patients that their physicians might recommend alternative treatments.
The Main Message
DTCA not only helps to educate patients about particular treatment options and motivates them to seek treatment, but also educates patients generally about their health and leads to a more open and productive dialogue between patients and their doctors. However, in order to ensure that DTCA continues to have a positive impact on patient health, drug companies must continue to educate doctors honestly about the risks and benefits of the medications they market, and doctors must remain guardians and stewards of the health of their patients by providing their patients with honest, informed advice and remaining both vigilant and courageous enough to counsel them against the use of drugs inappropriate for the patients' medical needs.
Alan Klein is a partner and Jenna Evans an associate at the firm of Duane Morris, which has defended pharmaceutical firms and others in tort cases. Donald B. Parks, M.D., practices at Parkstone Medical Associates and is an associate professor of community medicine at Temple University. See also: Dr. Gilbert Ross, ACSH Medical and Executive Director, addressing direct to consumer drug ads on TCSDaily.com, and ACSH's brochure and full report on weighing the benefits and risks of drugs. 
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