Randomized controlled trials (RCTs) may have lots of problems, but they remain the “gold standard” to determine whether a drug or treatment works. A recent study published in the BMJ, again raises concerns about trusting clinical trial results. The situation is outlined in an article in the New York Times about the antidepressant drug Paxil (paroxetine) and its safety in teens. The original study was published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) and the authors concluded that Paxil is “generally well tolerated and effective” for adolescents with major depression. However, since that time, experts have questioned whether the data really supports this conclusion and whether Paxil is really safe in young adults with depression.
In the recent BMJ analysis, the authors looked at the data from the original 2001 study and also some additional data they were able to get from the drug company that makes Paxil, GlaxoSmithKline. They concluded that Paxil is neither safe nor effective in adolescents with depression.