Here's a study guaranteed to put almost every drugmaker on the defensive. Researchers analyzed every antidepressant study they could get their hands on--including a bunch of unpublished data obtained via the U.S. Freedom of Information Act--and concluded that, for most patients, SSRI antidepressants are no better than sugar pills. Only the most severely depressed get much real benefit from the drugs, the study found.
That's quite a conclusion, considering that antidepressants are among the world's top-selling meds, accounting for billions in revenues every year. Manufacturers rushed to defend their products, saying that regulators in many countries had reviewed the data and concluded the drugs were effective. GlaxoSmithKline, for instance, said that this new study only looked at "a small subset of the total data available."
But the study didn't come as a surprise to some, including one U.K. expert who's published research showing that drug companies only tend to publish data that shows their products in good light. The new paper, published today in the journal PLoS Medicine, breaks new ground, according to The Guardian, because the researchers got access for the first time to an apparently full set of trial data for four antidepressants: Prozac (fluoxetine), Paxil (paroxetine), Effexor (venlafaxine), and Serzone (nefazodone). And the data said..."the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance." Ouch.
The study could have a ripple effect, affecting prescribing guidelines and even prompting questions about how drugs are approved. "This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported," one of the researchers said. In other words, all trial data needs to be made public.
- read the coverage from the BBC
- see this article and column in The Guardian
- see this Q&A about the study in The Telegraph