Study 329: Antidepressant trial's upended results show need for sharing all data
Key Excerpts from Article on Website of International Business Times
Posted: October 4th, 2015
In 2001, a "landmark" study published in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry purported to show the safety and effectiveness of using a common antidepressant to treat adolescents. The original published findings were biased and misleading. Known as Study 329, the randomised controlled trial ... was funded by SmithKline Beecham now GlaxoSmithKline (GSK) the manufacturer of paroxetine. The research has been repeatedly criticised, and there have been numerous calls for it to be retracted. To re-analyse the evidence of effectiveness and safety of paroxetine, we used documents posted online by GSK. We also had access to other publicly available documents and individual participant data. We found that paroxetine [Paxil] was no more effective than a placebo, which is the opposite of the claim in the original paper. We also found significant increases in harms with both paroxetine and imipramine, [another antidepressant]. Compared with the placebo group, the paroxetine group had more than twice as many severe adverse events, and four times as many psychiatric adverse events, including suicidal behaviours and self-harm. And the imipramine group had significantly more heart problems. Our re-analysis ... identified ten strategies used by researchers in this clinical trial to minimise apparent harms. More importantly, our findings show influential peer-reviewed research published in leading medical journals can be seriously misleading.
Note: We all know that clinical trial are skewed when they are sponsored by drug companies, but here is undeniable proof of this published in the UK's most respected medical journal. See this key study on the website of the British Medical Journal. Then don't miss that amazing documentary "Bought" available for free viewing.