We've heard a fair amount this year about negative drug studies that go unpublished. And now there's more. A research team at University of California-San Francisco is accusing drugmakers of distorting the results of their clinical trials in medical journals. That distortion makes it difficult for physicians to judge whether to prescribe new drugs, the team said, which means patients may take meds prescribed on the basis of inadequate information.
As you know, drugmakers have to hand over all their trial data to the FDA when they submit a drug for approval. The researchers looked at 164 of those trials conducted over a two-year period, tracking the publications that emerged. They discovered that "really important information from the official trial reports that were either not published at all or that stressed mostly the positive results of trials in the published versions," one of the investigators told the San Francisco Chronicle.
Responding to the Chronicle, PhRMA said doctors can find all the prescribing info they need in each drug's FDA-approved labeling. But it's not just the UCSF researchers who've been finding unpublished trials. University of Washington doctors reported in Oncology that only one in five cancer trials is ever disclosed. And SUNY reviewed 1,385 research articles from four journals, finding that a third of them never even mentioned side effects.
It's true that new rules require basic info on clinical trials to be registered on ClinicalTrials.gov, an NIH website. And basic outcomes info has to be disclosed, too. So there's hope of new transparency in drug data.