January 1, 1970 (Vol. , No. )
Michael S. Koeris
Most studies that are submitted to the FDA never make it into medical journals that doctors consult to evaluate drugs’ overall safety and effectiveness, a study found. Shocking news to say the least.
All tongue-in-cheek aside, though, it’s clear there is a disparity that the FDA needs to address. Researchers looked at medicines approved between 1998 and 2000, and found that 394 out of a total of 909 studies submitted to FDA were published (they cut off their search at five years after approval). That’s 43%, i.e. for those of us who think more big picture: less than half.
Studies with statistically significant findings and, not surprisingly, typically those that show a drug is better than placebo—THOSE were the ones more likely to be published than studies with insignificant findings. And so-called pivotal trials, the big studies on which approval often hinges, were published 76% of the time.
A law passed in 2007 will change the landscape of what’s publicly available, i.e. starting Saturday, drug makers will be required to post study outcomes on the online trial registry clinicaltrials.gov.
The study, by researchers at UCSF, is published in PLoS Medicine.