Drug companies distorting trial information, says UCSF study

January 1, 2009

Investigators at University of California, San Francisco, examined 164 drug trials and their reports. Published reports tended to be more favorable than information reviewed by FDA. Bias is suspected.

Key Points

A team of medical investigators at the University of California, San Francisco, has accused drug companies of bias by distorting the results of their trials in medical journals, which many physicians rely on to determine whether to prescribe new drugs. As a result, the researchers say, patients may sometimes be taking medications they don't need or that have unwanted side effects, which their physicians have prescribed on the basis of inadequate information.

The UCSF team, led by Lisa A. Bero of the medical center's Institute for Health Policy Studies, probed the details of 164 drug trials involving as many as 1,500 patients over a two-year period and then examined reports on those trials that were published in medical journals, as well as those that remained unpublished.

Discrepancies discovered between the trial information reviewed by the FDA and information found in published trials tended to lead to more favorable presentations of the NDA drugs in the publications. Thus, the study concluded, the information in the scientific literature that is readily available to healthcare professionals is incomplete and potentially biased. Study results were published in the current issue of PLoS Medicine, an online medical journal.