Pharmalot – By Ed Silverman // February 15th, 2012 // 12:11 pm.
Last month, a series of studies published in BMJ reported various problems with clinical trial data. More specifically, there is a lot that goes unpublished. Although the Food and Drug Administration Amendments Act requires mandatory reporting of summary clinical trial results within one year of completion on ClinicalTrials.gov, one BMJ paper found that only 22 percent adhered to the mandate (back story).
And so a trio of House Democrats – Henry Waxman, Ed Markey and Diana DeGette – has written FDA commish Margaret Hamburg and National Institutes of Health director Francis Collins to ask what these agencies are doing to enforce the mandate. The NIH is responsible for maintaining the public database of trial results, while the FDA is responsible for enforcing statutory reporting requirements.
The law “was enacted in response to similar reporting failures that contributed to dangerous or ineffective drugs remaining on the market far longer than they should have. For example, results of clinical trials for Vioxx and Avandia – which revealed that the drugs posed significant safety risks – were not made public until long after their completion, resulting in these drugs being prescribed to far more patients than likely otherwise would have occurred. The new study suggests this underreporting is continuing today,” they write (here is the FDA letter and the NIH letter).
The reason for the mandate should be clear. By registering trials with ClinicalTrials.gov, drugmakers would presumably find it more difficult to cherry pick data in order to bolster favorable study outcomes and journal editors can more easily verify protocols. Theoretically, this process should also make life easier for researchers who want to gaze at raw data when compiling a meta-analysis. But if only a minority of trials are registered then, of course, the system is failing. Read Full Article