Register or Perish

Looking to make the downside of therapies known


When Bjorn Olsen of Harvard Medical School began work on the Journal of Negative Results in Biomedicine, some assumed the project was a gag. The peer-reviewed journal publishes serious research; it is just that its vision runs counter to traditional medical publishing, which tends to hide negative findings, such as a drug study that turns up adverse side effects but no measurable improvement. This publication bias is troubling because decisions based on a skewed sense of relative risks and benefits can be a matter of life or death. That was the problem in the Paxil case, in which the State of New York sued GlaxoSmithKline for suppressing data showing that the antidepressant increased teens' risk of suicide.

Now, thanks largely to the Paxil case, two recent moves are tackling the problem of publication bias. First, a group of leading journal editors announced in September a policy, effective July 2005, requiring all clinical trials to be registered from the get-go to be considered for publication in their journals. The editors expect this policy to reduce the bias toward favorable results, because researchers will have gone on the record before they know how the study will turn out. Then, in October, six Democratic lawmakers introduced House and Senate bills that would require drug companies to register clinical trials and report results in a public database ( Registration in this National Institutes of Health database is already mandatory for research on "serious and life-threatening" diseases, but lax enforcement has led up to half of all such trials to go unregistered.

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