A quick heads-up: Nature weighs in on the flap over the Kirsch SSRI study that found antidepressants no more effective than placebo. I’ve given a lot of attention to the placebo issue. Nature stresses another point: That the Kirsch study underscores the need for clinical trial data to be public. At present it is not, as the drug companies have persuaded the FDA that releasing all trial data might reveal trade secrets. Nature argues — as have many — that what’s being hidden is not proprietary trade secrets but information vital to public health:
No more scavenger hunts
The recent media flap over antidepressants highlights the need for data to be transparent %u2014 and for a mandatory database of all clinical trials.
It was not the media’s finest hour. When a study was released last week challenging the effectiveness of several popular antidepressant drugs, some news outlets, particularly in the United Kingdom, responded with headlines blaring ‘the drugs don’t work’ %u2014 even though the drugs often do work. Yes, the study showed that the drugs often performed no better than a placebo. But what many of the media missed was that the placebo effect can be remarkably strong in psychological and neurological disorders, especially in mild depression. Doctors scrambled to assure patients that they should not abandon treatment.
Almost buried in the hubbub, though, was a more important story. To access the data needed for this study %u2014 a meta-analysis of 35 clinical trials %u2014 the researchers had to file a Freedom of Information Act request with the US Food and Drug Administration. And the information they finally received was incomplete: crucial data were missing for several studies that failed to find a significant benefit of the drug compared with the placebo. The missing data limited the analysis, and forced the researchers to abandon their investigation of two drugs altogether.
Such data chaos has become all too familiar in the world of clinical trials. And that fact, combined with recent scandals about antidepressants, diabetes drugs and cholesterol medications, has spurred an outcry to make clinical-trial registries mandatory.