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Monday, 1 May 2017

Clinical Trial Study 329 Ghostwritten by GSK - reanalysis of review of Seroxat Paxil


Restoring Study 329 - The study that disproved anti-depressants’ efficacy

A major reanalysis of the infamous clinical trial, Study 329, has shown Paroxetine (also known as Paxil or Seroxat), one of the most commonly prescribed antidepressants, to be unsafe and no more effective than a placebo.

This new assessment directly contradicts the results of the clinical trial that claimed Seroxat to be “generally well tolerated and effective”, which was sponsored by and ghostwritten for GlaxoSmithKline, despite using the same original data.

The latest paper was published under the restoring invisible and abandoned trials (RIAT) initiative, in order to re-evaluate any conclusions drawn from evidence that had previously been hidden from public view.

Published in 2001, Study 329 generated a high level of controversy from patients and doctors after lawsuits were filed stating the side-effects were much more serious than those documented in the clinical trials.

Restoring Study 329, showed Paroxetine (Seroxat or Paxil) to have no significant reduction of depressive symptoms more than a placebo or previous anti-depressants, and gave users a higher chance of psychiatric side effects.

The original study came under intense scrutiny following revelations that it was ghost written by GSK authors and not those named on the study, and the primary data was not made publically available.

The findings of Study 329, originally published in 2001, was the first double blind patient study to report the efficacy of anti-depressants on adolescents.

It has allowed Seroxat to gain widespread approval by the healthcare industry, becoming the most widely prescribed anti-depressant in the US, with over 14 billion dolllars worth of sales between 1997 and 2004.

Following a decade of public and legal pressure, GSK finally released the original data to the public, making its reanalysis possible.

These devastating results overturning the original paper may come as no surprise to many who have already suffered loss and harm from the drug. In  2012 GSK were successfully sued $3 billion for fraudulently promoting Paroxetine to the public, and hiding key data in its study, such as reclassifying suicidal acts so that they would not count in the final analysis.

To this day however, GSK remain silent on the issue and continue to promote the drug to its customers, without any attempt to acknowledge the restoration of the study.

A personal note to our readers:

As we reveal these facts about Seroxat, we do not wish to condemn all use of anti-depressants nor encourage the immediate withdrawal from the medication.  It is important to obtain advice from responsible health professionals who can help to plan any reduction in drugs that may cause dependence. It is also important to inform those close to you when you plan to start, reduce or stop taking antidepressants and to obtain professional medical or support group assistance and advice. 

We wish to highlight the potential dangers and risks of Paroxetine and similar medication, and let readers understand that medical information to support the drug can be unreliable or biased.

Both starting and coming off anti-depressants is a serious undertaking and we strongly advise that users seek professional medical help as well as inform either close friends or family when doing so, as it can be a tough process which needs careful monitoring and support.

Dealing with life events can cause anxiety but may not be depression. We recommend considering talking therapy, possible CBT- cognitive behavioural therapy for those who have access to these services, as these have been shown to provide beneficial reductions of depression and anxiety with fewer and less serious side effects.

Specialised bereavement counselling is also of benefit as it is more difficult for some people to express grief when blocked by drug effects.

 

©JBforAPRIL

 

Further Reading

 

Article on Study 329


British Medical Journal Analysis of Study 329


David Healy’s website on the controversy of Study 329


Restored Study 329


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