Alison Bass: Psychiatric journal refused to retract flawed antidepressant study

The Journal of the American Academy of Child and Adolescent Psychiatry has refused to retract a study finding that the antidepressant Paxil was safe and effective in adolescents despite evidence of fabrication, plagiarism and failure to disclose conflicts of interest on the part of its authors, according to two academic researchers.

In a paper published yesterday in the journal Accountability in Research, Jon Jureidini and Leemon McHenry recount the myriad flaws of study 329, the same clinical trial that prompted a New York State Attorney General's lawsuit against Paxil's maker, GlaxoSmith Kline, in 2004. The story of that lawsuit and how it helped propel reforms in the way drugs are tested and marketed is the subject of Side Effects. In that book, I exposed how the authors of study 329 failed to fully disclose their lucrative financial ties with GlaxoSmithKline and how they misrepresented the data in the study to make Paxil look safer and more effective than it really was. I've also written about the study's extensive flaws in my blog here and here.

In this week's paper, Jureidini and McHenry concluded that study 329 violated JAACAP's written policy in several ways:

1. Failure to disclose conflicts of interest of "authors."
2. GSK concealed commercially damaging data (about the study).
3. Fabrication (creation of a strong false impression that one primary outcome measure was positive by deliberately confusing it with another measure).
4. Falsification (post hoc changes to secondary outcome measures and misrepresentation of severe adverse effects).
5. Plagiarism (submittting a ghostwritten manuscript).

via alison-bass.blogspot.com

Posted via email from Jack's posterous