February 2001
It Is Time for Canada to Rethink its Ban on Direct-to-Consumer Advertising of Prescription Drugs
by John E. Calfee
Among the many differences between health care in Canada and that in the United States is the regulation of prescription drug advertising. Canada prohibits the advertising of prescription drugs directly to consumers, as does the UK, the rest of the EU, and indeed virtually all developed nations (New Zealand notably excepted). In the US, however, direct-to-consumer (DTC) advertising has been permitted in print media since the mid-1980s, and on radio and television since August 1997, with the requirement that ads must present a fair balance of risks and benefits, be non-deceptive, and refer to sources of additional information.
Canadian law on prescription drug advertising to consumers is explicit and sweeping: the Food and Drugs Act prohibits any advertising on the use of drugs to prevent or cure disease, and specifically states that the rule applies to the treatment of serious conditions such as cancer, diabetes, and heart disease—even if the advertising is neither deceptive nor misleading. This policy is supported by a regulatory system dedicated to discovering infractions and bringing them to a halt, with little or no regard for the actual effects that advertising might have.
Clearly, we are in the middle of a natural experiment in which one of world's most economically advanced nations prohibits DTC advertising while its neighbour, also a member of that envied club, permits DTC ads to the tune of some US$3 billion annually. This experiment has begun to yield some useful results, and one suspects that those results are quite different from what most Canadians expect.
The most fruitful source of information comes from a series of well-designed consumer surveys on DTC advertising, one commissioned by the FDA in 1999, and several commissioned by Prevention Magazine in the past few years.1 These surveys have told us a lot about what DTC advertising does and, equally important, what it does not do.
One thing the ads do is draw people's attention to the fact that important medical conditions can be treated, or treated better than before. Twenty-seven percent of the FDA survey respondents said that DTC ads had prompted them to discuss a medical condition with their doctor for the very first time. This is an extremely important finding. A long series of professional consensus reports have documented that all sorts of serious illnesses and conditions—including depression and other mental disorders, coronary heart disease, hypertension, diabetes, and obesity—remain undertreated or even undiagnosed despite the promulgation of detailed practice guidelines designed to resolve the undertreatment problems. A recent example is the November 1999 US Surgeon General's report on mental health treatment, but that is simply one of many authoritative statements to document the persistent tendency for consumers and patients to suffer needlessly while effective treatments remain unused.2
Under-treated medical conditions are the focus of a large proportion of DTC ads; good examples are ads for Lipitor® and Zocor® and other cholesterol-reducing drugs. The result is familiar to advertising scholars: DTC advertising is filling an informational void, reaching out to consumers and patients and their families to provide essential information and urge them to talk to their physicians (which is, of course, the only way to obtain the advertised drugs). The fact that DTC advertising works this way is hardly a surprise, because research has demonstrated similar benefits from advertising in markets ranging from foods to legal services.
The consumer surveys also found that DTC ads tend to highlight risk information. In fact, FDA and Prevention survey respondents said they actually read a lot of the risk information in ads, especially when the ads are about a drug they are taking or might want to take.
At the same time, DTC ads tend to make patients feel more comfortable with their medicines, so they are more likely to obtain refills and otherwise comply with the therapeutic regimes specified by their doctors. In effect, advertising is helping to solve one of the oldest and most serious problems in medicine, which is getting patients to comply with their drug therapy.
One could go on at length about what DTC ads do, but it is just as important to understand what they do not do. FDA rules ensure that ads do not emphasize benefits while pushing risks aside. On the whole, the two kinds of information (risks and benefits) are equally prominent in the eyes of FDA survey respondents. Of course, anyone paying attention to DTC ads, with their voluminous fine print and lengthy TV voiceovers, could hardly remain ignorant of the simple fact that even the best prescription drugs involve side-effects. The FDA and Prevention surveys actually found that DTC ads provide heightened awareness of risks, as well as benefits, from prescription drugs.
A crucial finding, much to the FDA's pleasure, was that consumer surveys strongly indicate that DTC ads do not disrupt patient-physician relationships. Large majorities of survey respondents—easily two-thirds or more—found DTC ads to be useful. Overwhelming majorities reported no adverse experiences when they discussed advertised drugs with their doctors. In fact, doctors treated questions about drugs and advertising as a normal part of their discussions with patients.
The practical implications of these emerging data are of great importance. In August 1999, after reviewing some of these same survey results, the FDA reaffirmed its August 1997 decision to permit DTC advertising on radio and television. The agency specifically noted that the "FDA is unaware of any data supporting the assertion that the public health or animal health is being harmed, or is likely to be harmed, by the Agency's actions in facilitating consumer-directed broadcast advertising."
Perhaps it is time for Canada to perform a similar reassessment of its own position on DTC advertising. With physicians spending less and less time with patients, especially in conversations about drug therapies and their effects, there can be no doubt that advertising is providing or provoking the dissemination of essential drug information that otherwise would reach patients more slowly or not at all.
What DTC advertising does is harness market incentives in the service of consumers and health. When people suffer because they fail to avail themselves of valuable medical therapies—simply because they know too little about them—the manufacturers of those therapies are often among the very few parties with a financial stake in bridging that information gap. Think about what happens when a prescription drug ad encourages a middle-aged man to see his doctor for a blood cholesterol check, followed by serious discussions about diet, exercise, and maybe (but only maybe) a prescription for a statin-class cholesterol-reducing drug. The advertiser may have done a little to help its financial bottom line, but it has done much more to help the millions of men who routinely ignore years of earnest advice from spouses, friends, and public health pundits. A ban on DTC advertising gets in the way of some of the most useful work that can ever be done by marketing.
There is more. The ability to market valuable therapies increases the incentives to create those therapies in the first place. Some of the most important medical cures will remain useless unless there is a way to communicate their benefits directly to consumers. One thinks of drugs for such notoriously hard-to-reach groups as those suffering from depression or type II diabetes. Limitations on the ability to promote new and better cures translate into limitations on the ability to develop cures. Surely, Canadians would be better off with fewer restrictions and better medicines.
Notes
1 The FDA survey is available at www.fda.gov/cder/ddmac/dtcindex.htm. The Prevention survey is found in Prevention Magazine (1999), "A National Survey of Consumer Reactions to Direct-to-Consumer Advertising."
2 The mental health report is US Public Health Service (1999), Mental Health: A Report of the Surgeon General. Washington, D.C.: GPO. An interesting article from the American Medical Association on the failure of physicians to comply with practice guidelines is American Medical News, December 27, 1999, "Not-in-Practice Guidelines." For many more examples of authoritative consensus statements on widespread under-diagnosis and under-treatment of serious medical conditions, see pp. 24-25 of John E. Calfee (2000) Prices, Markets, and the Pharmaceutical Revolution. American Enterprise Institute, Washington, D.C.
John E. Calfee, Ph.D. is a Resident Scholar at the American Enterprise Institute in Washington, D.C., and the author of Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000) and Fear of Persuasion (Agora Press, North American distribution by the American Enterprise Institute).
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