Direct-to-consumer advertising of prescription drugs

These ads present both perils and opportunities

The pharmaceutical industry has long relied on marketing to move drugs from manufacturers' laboratories to consumers' medicine cabinets. From 1938, with the passage of the Food, Drug and Cosmetic Act, until the mid-1980s, the industry focused its efforts almost entirely on physicians. Correctly recognizing physicians as their principal customer, drug manufacturers deployed large armies of sales representatives who marched into physicians' offices bearing promotional materials, drug samples, coffee mugs, “continuing education” dinner invitations, and baseball tickets.

Relying solely on promotion to physicians made sense when they exercised uncontested control over prescribing, but changing times have meant changing strategies. In recent years, the phenomenon known generically as “managed care” has sparked the widespread proliferation of drug formularies, utilization review systems, and pharmaceutical risk-sharing agreements. As a result, physicians cannot just prescribe whatever seems reasonable and appropriate following a delicious drug company—sponsored scampi dinner. They must sometimes be pushed to prescribe and to insist—in the face of resistance from group medical directors and chairs of formulary committees—on the brand name drug over the generic, the new drug over the old, and the profitable drug over the unprofitable. And who better to provide the pushing than the patient, now an enlightened “health care consumer”?

Drawing on these insights, the pharmaceutical industry has altered its marketing strategy to include direct-to-consumer advertising. The Food and Drug Administration, after a long moratorium, decided that these ads required no new regulation beyond the “fair balance provision” of the 1962 Kefauver-Harris amendments, which requires that manufacturers truthfully present a fair balance of risks—side effects and contraindications—and effectiveness. Expenditure for this advertising currently comprises 15% to 20% of total drug marketing costs and is projected to increase to $7.5 billion by 2005.

The arguments for and against direct-to-consumer advertising are already becoming a little tiresome, even to one who has been actively engaged in the debate.^1,2 In general, proponents claim that “by greatly increasing the likelihood that patients will seek help for their medical problems and receive a safe and effective prescribed medicine, DTC advertising will... play a very real role in enhancing public health.”³

Critics counter that

extending the scope of already ubiquitous promotions about “post-nasal drip,” “unsightly rashes,” or “cures” for baldness has little to do with educating patients or relieving suffering. It will, however, inevitably drain healthcare dollars, dramatically increase unnecessary prescribing, and strain patient-doctor relationships.⁴

With nothing less than the health of the public at stake, not to mention billions of dollars, it is no wonder that the debate has veered toward acrimony. Each side has tended to overstate its case. Yes, these ads may prompt some patients to seek care for previously undiagnosed and untreated conditions. And, yes, they may spur other patients to make unnecessary visits to the doctor and to incur the risk of medication side effects while gaining little benefit. However, the net benefits and risks of direct-to-consumer promotion are unknown. The research required to make these assessments is difficult.

The net public health gain or loss of this advertising will be determined by 3 things: the current prevalence of undertreatment (the number of patients not receiving drug therapy who should be), the amount of inappropriate or harmful prescribing that might be stimulated by such ads, and the degree of harm accruing to undertreated compared with overtreated patients. Until substantial resources are allocated to this research agenda, we will not know which side is right. In practical terms, however, it may not matter. Direct-to-consumer advertising is here to stay. The real question is how it should be delivered so as to maximize the benefits while minimizing potential harms.

Here is my prescription. Drug manufacturers should do more educating and less selling. This means focusing on conditions rather than drugs; assisting patients with home-based triage and self-care; presenting information on treatment alternatives, including nonpharmacologic therapies; helping patients who decide on medication to optimize adherence; and promoting partnerships with physicians. As an example of partnership, drug firms should alert physicians before launching direct-to-consumer ad campaigns and help them prepare for questions their patients are likely to ask. Government should, in the words of an American College of Physicians' position paper, “impose serious limits on the pharmaceutical industry to ensure that consumers receive complete and nonconfusing information.”⁵ The FDA's current policy of retrospective review is inadequate. Government should also fund research to ensure that in 5 years we will know more about the true benefits and risks of this advertising. The medical profession should partner with government, foundations, and the news media to create sources of objective consumer drug information, such as a “Medical Letter” to consumers, and public service announcements alerting consumers of undertreated conditions, like depression and hyperlipidemia. In the meantime, physicians should brace themselves for growing hordes of patients bearing ads.