Should Paxil be banned? The only ‘evidence’ of effectiveness was ghostwritten by Glaxo Smith Kline’s public relations firm
(NaturalNews) In 2001, a study was published in the Journal of the American Academy of Child and Adolescent Psychiatry, showing that the SSRI antidepressant paroxetine – sold under the names Paxil, Aropax and Seroxat – was safe, well tolerated and effective for the treatment of depression, obsessive-compulsive disorder, post-traumatic stress disorder and social anxiety in adults and teenagers.
However, a recent reanalysis of the same data, published in the British Medical Journal (BMJ), reports that the opposite is true. It is the first reanalysis of a drug trial by a collaboration of researchers called RIAT (Restoring Invisible and Abandoned Trials). Their aim is to correct abandoned or misreported studies to ensure that doctors and patients are given the most accurate information.
The original study, known as Study 329, was authored by Dr. Martin Keller, et. al., but it was actually ghostwritten by Sally Laden, who was hired by the drug manufacturer Glaxo Smith Kline (GSK). Severe adverse effects of the drug were vaguely described and deliberately left out of the report. GSK used Study 329 to promote the use of Paxil in depressed teenagers.
While drug companies aren’t allowed to promote drugs for unapproved uses, doctors took the results for granted, and prescription of these unapproved drugs for off-label use skyrocketed over the years.
The drug brought in $11.6 billion between 1997 and 2006. By 2007, it was one of the most prescribed antidepressant drugs in the U.S., with more than 18 million annual prescriptions.
Suicidal thoughts and behavior
In the years after Study 329 was published, doctors and concerned parents worldwide reported signs of suicidal thoughts and behavior among teens who were prescribed paroxetine to treat depression. For years, small groups of patients and doctors have voiced their fears about SSRIs such as Paxil. However, many clinicians and drug companies disagreed, relying heavily on the findings published in Study 329.
In 2002, the U.S. Food and Drug Administration (FDA) was finally alarmed, and began researching the potential dangers. The results were clear, but instead of taking the drug off the market, they only advised doctors not to prescribe it to teens suffering from depression.
In 2004, an FDA panel voted that manufacturers be required to include a black box warning on every package. It should clearly state that taking Paxil or other SSRI drugs increases the risk of suicidal thinking and behavior in children, young adults and adolescents. The warning also states that anyone who takes SSRI’s to treat depression should be closely watched for significant changes in their behavior.
Despite rising concerns and evidence regarding the lack of safety and effectiveness, Study 329 lived on. It was never questioned, retracted or edited – until now.
Reanalysis reveals alarming results
After years of trying to access GSK’s data, researchers from the RIAT finally got their hands on more than 77,000 pages of patients’ information.
According to author Dr. Jon Jureidini, professor and research leader of critical and ethical mental health at the University of Adelaide, the authors of the original Study 329, “deliberately misrepresented the outcomes of the study,” and changed the protocols of the study without following the proper procedures to do so.
He further notes that adverse events were not reported in the correct way. While studying the patient-level files, they found suicide attempts that were severe enough to require hospitalization. However, these findings were vaguely labeled as “emotional liability.”
The RIAT’s reanalysis shows that our medical system is flawed, and that doctors do not have access to enough unbiased information to make the right decisions for their patients.
In a press release, Dr. Fiona Godlee, The BMJ Editor-in-Chief, stresses the need for independent clinical trials by third parties, rather than relying on the papers funded and written by the drug industry itself.
More resources should be allocated to alternative treatments that are effective and safe. Mindfulness based cognitive therapy, for instance, has shown some great results in treating depression, anxiety and stress. If you are interested in natural treatments and want to learn more, check out the Natural Medicine, Healing & Wellness Summit here.
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