Re-Analysis of Medical Study Reverses Conclusions -- Paxil Unsafe For Teenagers

An anonymous reader writes: The NY Times is covering a new paper in the journal BMJ which re-analyzed data from a 2001 paper, coming to the opposite conclusions of the earlier study. The BMJ paper covers the effectiveness and safety of two antidepressant drugs for adolescent use, and the authors were able to re-analyze the original data after the release of previously confidential documents. The BMJ editors call into question some of the integrity of previous publishing, noting that none of the authors listed on 2001 paper actually wrote the original manuscript, and call for results of clinical trials to be made freely available so the science community can verify and self-correct results. The BMJ has released the study and provided an accompanying press release (PDF).

Comments

Re:Why do teens *need* all these drugs???

[gstoddart]

Sure, but if fabricating science to sell a product for an application not approved or supported by the science really needs to be the kind of thing which leads to very significant legal action and penalties.

Essentially they fabricated a study to support a use of a drug, and the conclusions in that study were not founded .. because it wasn't a real study.

Sorry, but that's pretty much a criminal activity in my books.

Re:Why do teens *need* all these drugs???

[gstoddart]

Troll?? Really?? This is from the last link in the summary:

Results The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.7 (least squares mean) (95% confidence interval 9.1 to 12.3), 9.0 (7.4 to 10.5), and 9.1 (7.5 to 10.7) points, respectively, for the paroxetine, imipramine and placebo groups (P=0.20). There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.

Conclusions Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.

Unless you work for GSK or are one of the original authors, my summary of the conclusions is pretty damned accurate: they fucking lied about badly done science.