Time for a Drug Test Registry

The Washington Post ^ | August 13, 2004 | Marcia Angell

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Reports that the drug giant GlaxoSmithKline buried evidence that its top-selling antidepressant, Paxil, is not effective in children have stimulated calls for a public registry of company-sponsored research. It's about time. You might imagine that this was an isolated case of corporate misbehavior, but in fact suppressing unfavorable research results is fairly standard practice in the pharmaceutical industry.

Before drug companies are allowed to bring a new drug to market, they are required by the Food and Drug Administration to conduct clinical trials to show that the drug is safe and effective. They are supposed to provide the agency with the results of all the trials, not just some. But they don't have to publish or otherwise make the results available, and neither does the FDA. Moreover, the FDA may approve a drug on the basis of a few trials that make it look good, even though other trials may indicate it is not effective. The companies selectively publicize the most positive results, and legions of sales representatives then visit doctors to tout the positive findings.

Just as troubling as the outright suppression of unfavorable research is the bias in the research that is published. Clinical trials can be set up to make drugs look good, and that, too, has become common. Companies can, for example, enroll only young people as human subjects, even if the drug is likely to be used by older patients -- thereby lessening the chance that side effects will show up. Or they can compare a new drug with an older drug administered at too low a dose, which means the new drug is bound to look better.

[neverdem]

The writer is a former editor in chief of the New England Journal of Medicine and author of the forthcoming book, "The Truth About the Drug Companies."

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