I’ve written before, both here and in print, about how FDA policy and drug company practices have allowed drug makers to publish (and the FDA to base approval on) only the most flattering drug-trial results while keeping less-flattering studies in the drawer. Today a New England Journal of Medicine report shows how things change when you include the results from the drawer: The effectiveness of many SSRIs dives to near placebo-level. This despite that the companies design and conduct most of these trials in a way calculated to produce positive results.
When I wrote on this for Scientific American Mind a couple years ago, UCSF professor and Journal of the American Medical Association editor Drummond Rennie, told me, “If a company does ten trials on a drug and two show it helps but eight show it works no better than Rice Krispies, I’m not exactly getting a scientific view if they publish only the two positive studies…. How can we practice sophisticated medicine if the drug companies are hiding their results? That’s not science. That’s marketing.”
The problem remains. Depressing. I recommend a good run.
Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.