How to Fix Drug Ads

If you've ever had doubts about the power of advertising, take a look at a recent study appearing in the Journal of American Medical Association.1 Richard Kravitz, from the University of California, Davis, and colleagues found that when "standardized patient" actors portraying depression visited doctors and asked for Paxil, 27% of them walked out with a prescription for the drug, compared to just 3% of patients who described the same symptoms but did not ask for Paxil. That finding should be considered in the context of the fact that there are three other antidepressants in exactly the same class as Paxil and countless other treatments available, some of which don't involve any medication. Other surveys2 have found that about 40% of patients who asked for a specific drug left their doctor's offices with a prescription for it.It's no wonder, then, that direct to consumer (DTC) pharmaceutical advertising is a $4 billion industry, according to some unofficial estimates. Everyone wants a piece of this pie. The mass-market media, for example, are eager to create health sections and broadcasts that cater to this lucrative revenue stream.Still, despite benefiting from the world's most obliging DTC regulations, companies in the United States persist in pushing the envelope. In 2004, the Food and Drug Administration's division that monitors DTC ads sent 12 warning letters to companies whose ads they found misleading, reports Dana Wilkie on page 35 of this issue. That compares with an average of four or five letters in previous years, according to an FDA spokesperson, and is a sign of stepped up enforcement.Just last month, the agency warned Bayer Pharmaceuticals, Schering-Plough, GlaxoSmithKline and Pfizer for misleading ads. For Pfizer, it was the fourth such warning on the allergy medication Zyrtec. Moreover, Pfizer has just been censured for failing to include a warning about the risks of worsening depression or suicidal behavior in patients taking the antidepressant drug Zoloft.More scrutiny is likely ahead. Congress is looking into ways to ensure the accuracy of these advertisements, with some representatives suggesting that a certain period of time after approval of the drug, say three years, be required before such ads can appear.We'd like to suggest another weapon against irresponsibility: Toughen the penalties. Generally the FDA's warning letters threaten only that "failure to correct the violations ... may result in FDA regulatory action, including seizure or injunction, without further notice." Injunctions – a sort of "cease and desist" – can carry a fine, but we don't know of any cases in which the agency has ever actually sought an injunction for an advertising violation.What we would like to see is heavy fines replacing the warning letters. Otherwise, what is the incentive not to continue misleading ads? The upside of such ads is so tremendous, given the ads' efficacy, that the absence of fines is preposterous. Even light fines could be seen as just an acceptable cost of doing business. One valuable use for the collected fines would be in promotion of the FDA's own public health messages, for example, describing the health risks of drugs. In addition, FDA should compel companies to run corrective ads whenever a warning letter is issued.If any of these suggestions make drug companies uneasy, we refer them to the public face of their industry. The Pharmaceutical Research and Manufacturers of America's new president, Johnson & Johnson's CEO William Weldon, says other companies should follow J&J's lead by being more upfront about risks in their ads. That would be a good start.

How to Fix Drug Ads

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