The New England Journal of Medicine issued a report that said a third of FDA-registered studies on popular antidepressants went unpublished. Researchers compared unpublished data via the FDA, unpublished studies from their colleagues, and using the Freedom of Information Act (FOIA). But for most of us who don’t have time to FOIA federal databases, research summarized in unpublished studies remains effectively a secret.
Though PhRMA Deputy Vice President Alan Goldhammer said the study is outdated, the new report is actually the “most thorough to date” according to the New York Times, with 74 trials involving 12 drugs. “…[S]ince then we’ve put to rest the myth that companies have anything to hide,” said Goldhammer. The Consumerist posted this funny timeline, before and after.
Not good according to then New York Attorney General Eliot Spitzer. In fact, he filed a lawsuit against Paxil maker GlaxoSmithKline, saying they failed to demonstrate the drug’s effectiveness in treating children and adolescents. Safety and effectiveness should be an issue, since this report found that out of 38 “positive” trials, 37 were published, but only 14 of 36 “unconvincing” trials were.
The study’s lead author, Dr. Erick H. Turner, a psychiatrist and former FDA reviewer, said:
The bottom line for people considering an antidepressant, I think, is that they should be more circumspect about taking it, and not be so shocked if it doesn’t work the first time and think something’s wrong with them.
Added Dr. Jeffrey M. Drazen, The New England Journal editor in chief: “[Y]ou wouldn’t buy a stock if you only knew a third of the truth about it.”