Monday, October 30, 2006

Is Big Pharma burying bad data?

There is growing criticism of Big Pharma for failing to disclose results of clinical studies; especially studies that provide information about the safety or effectiveness of medicines being taken by consumers.

The charges became especially heated during the recent debate about the safety of antidepressants and the withdrawal of the once-popular painkiller Vioxx, which spurred accusations that, in some cases, side-effect data were suppressed.

The issue has prompted scrutiny from some members of Congress and calls by the editors of several leading medical journals to require greater, and quicker, disclosure of clinical trials.

Take the case of GSK and two trials of Valtrex vs Famvir, in genital herpes.

The trials finished in 1998, but the were only published last month.

The lead researcher for the studies complained she was never given a satisfactory explanation, and noted the drugmaker responsible for the delay also owns the medicine that fared poorly.

"I was given all sorts of reasons," said Anna Wald, a professor of medicine at the University of Washington, whose work comparing the two drugs was recently published in the journal Sexually Transmitted Diseases.

"It took years to receive any material," she said. "They should have moved faster."

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