Another case of promoting a drug with “incorrect reporting and distorted data”

There is a Catch 22 situation here.

Clinical trials for new drugs are all funded – of necessity – by the pharmaceutical companies. It is only to be expected that negative results are downplayed and positive results are highlighted. Positive results get published. Negative results for drugs not yet approved are rarely published. Those conducting clinical trials are looking to enhance their lists of publications. Furthermore there is an incentive to invent “medical conditions” which can be “treated” by otherwise useless – or even damaging – compounds. My perception is that the pharmaceutical companies sometimes discover compounds unintentionally or by accident or as a compound which fails its originally intended purpose. Then – by defining (or inventing) new medical disabilities – they try and find a use for these compounds.

So how many of the new, psychiatric drugs are really of no benefit? And how many of the supposed “illnesses” – which can only be diagnosed by subjective methods – and which these new drugs are supposed to to treat – are really medical conditions?

A University of Adelaide led study has found that a psychiatric drug – paroxetine – which was claimed to be a safe and effective treatment for depression in adolescents is actually ineffective and associated with serious side effects is published today in the BMJ.

Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ, 2015 DOI: 10.1136/bmj.h4320

there is also an editorial in the BMJ:

No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

UofAdelaide press releaseProfessor Jon Jureidini, from the University of Adelaide’s newly created Critical and Ethical Mental Health Research Group (CEMH) at the Robinson Research Institute, led a team of international researchers who re-examined Study 329, a randomised controlled trial which evaluated the efficacy and safety of paroxetine (Aropax, Paxil, Seroxat) compared with a placebo for adolescents diagnosed with major depression.

Study 329, which was funded by SmithKline Beecham (now GlaxoSmithKline), was reported in 2001 as having found that paroxetine was effective and safe for depression in adolescents. However, Professor Jureidini’s reanalysis showed no advantages associated with taking paroxetine and demonstrated worrying adverse effects.

“Although concerns had already been raised about Study 329, and the way it was reported, the data was not previously made available so researchers and clinicians weren’t able to identify all of the errors in the published report,” says Professor Jureidini. “It wasn’t until the data was made available for re-examination that it became apparent that paroxetine was linked to serious adverse reactions, with 11 of the patients taking paroxetine engaging in suicidal or self-harming behaviours compared to only one person in the group of patients who took the placebo,” he says. “Our study also revealed that paroxetine was no more effective at relieving the symptoms of depression than a placebo.”  ……

……. “Study 329 was one of the trials identified as in need of restoration, and because the original funder was not interested in revisiting the trial, our research group took on the task. 
“Our reanalysis of Study 329 came to very different conclusions to those in the original paper,” he says. “We also learnt a lot about incorrect reporting and the considerable fall out that can be associated with distorted data.”

If all doctors treating patients were truly independent the system would be self-correcting. Overhyped and unnecessary drugs would wither away. But many doctors have a vested interest in the continued use of the drugs they prescribe. (And note that even some members of the WHO panels who recommend mass vaccination programs have been found to have vested interests).

As the editorial in the BMJ writes:

But in the case of Study 329 no epistemological acrobatics would seem able to reconcile the differences between the 2001 JAACAP paper and the RIAT republication. They cannot both be right. …

Such stark differences between the original paper and the rewrite are bound to put particular pressure on Andrés Martin, Yale University professor and current editor in chief of JAACAP. Martin has been under pressure to retract the paper for years, including from within his own society. Last October, Martin was compelled to address the academy’s assembly about Study 329. According to the minutes, members heard how Martin had investigated the matter thoroughly by consultation with the authors, the Committee on Publication Ethics (COPE), clinical experts, “a whole range of attorneys, and more.” Martin’s assessment, completed in July 2010, concluded that no further action was necessary. A follow-up inquiry, again by Martin, in 2012, after GSK was fined $3bn, similarly concluded “no basis found for editorial action against the article.” ……

It has proved no easier to get the professional society to talk. Several of the authors of the JAACAP paper are members of the American Academy of Child and Adolescent Psychiatry (AACAP). The BMJ sent four requests for comment to the academy’s president, Paramjit Joshi, and past president Martin Drell, but received no response.

Scientists behaving badly and psychiatrists behaving very badly. A can of worms no doubt.

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