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Thursday, January 20, 2011

Seroxat Toilet Paper?


Calls for the infamous 'Seroxat in adolescents' published papers to be withdrawn is gathering momentum.

Jon Jureidini and Leemon McHenry are calling for the controversial 2001 paper in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) that concluded that Seroxat was “generally well tolerated and effective” for treatment of major depression in adolescents.

The paper misled healthcare professionals that read it as it showed impressive results treating adolescents with Seroxat.

Many lawsuits in the US have showed that the paper was way off skew with its claims. In items of disclosure presented in US courts documents show that company employees and public relations advisers also saw the trial data as having failed to prove that the drug worked in adolescents.

They all kept quiet.

Worryingly, JAACAP’s editors maintain there are no grounds for its withdrawal.

Jureidini and McHenry believe that journal editors are too reluctant to retract papers when the extent of this influence is revealed. Editors are “jeopardising their scientific standing and moral responsibility to prescribers and patients,” by failing to retract, they argue.

Study 329, a study of 275 adolescents, was one of three clinical trials conducted by SmithKline Beecham (as GSK was then known) in the 1990's. Results showed that Seroxat was no more effective than the placebo.

Bad news for Glaxo but great news for their spin team who turned the findings full circle to show that Seroxat was indeed effective in the treatment of adolescent depression.

It was a this point that SmithKline Beecham hired the services of Scientific Therapeutics Information, a medical communications company, of which Sally Laden was an employee. It was Laden who drew up the first 'spinning' draft.

Laden's manuscript was then sent to the Journal of the American Medical Association, which rejected it after peer reviewers highlighted problems.

The paper was rewritten and sent back to the JAACAP. Despite showing that the results did not “clearly demonstrate efficacy for paroxetine”, the JAACAP published it.

The paper is synonymous with ghostwriting. Martin Keller and some of the other 22 listed authors had previously worked for GSK or had received funding from them, but this was not declared. Sally Laden was listed as providing “editorial assistance.”

Both Jon Jureidini and Leemon McHenry called for the article’s retraction in December 2009, accusing GSK of intending to deceive by concealing negative data.

GSK, in typical fashion, denied this and threw out the tried and tested safety net line, “GSK remains firm in the belief that we acted properly and responsibly in the conduct of our clinical trials programme, documentation and submission of results from studies of paroxetine to regulators, and in communicating important safety information.”

Despite overwhelming evidence that shows the published paper to be false and misleading, editors at the JAACAP refuse to retract it.

Question is...why?

More on the study at the excellent Healthy Skepticism website

SOURCE - Neuroskeptic Blog



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