Posted on 02/16/2009 9:46:15 AM PST by drashok
Systematic Consumer Fraud by GSK (GlaxoSmithKline)in conspiracy with researchers who were bribed to suppress or obscure suicide risk data during clinical trials of one of the highest selling medicines-Paroxetine.
(Excerpt) Read more at news.bbc.co.uk ...
DRUG BRAND NAMES:
In US, UK: Paxil, Seroxat
In India: Pexep, PaxidepCR
MEDICINE'S GENERIC NAME:
Paroxetine
ABOUT MEDICINE
Paroxetine is used is one of the world's biggest selling, most successful anti-depressants. The blockbuster drug Paroxetine generated about a tenth of GSK's entire revenue.
COURT EXPOSED GSK/RESEARCHERS FRAUD
The court documents released as a result of one of the lawsuits in October 2008 indicated that GSK "and/or researchers may have suppressed or obscured suicide risk data during clinical trials"
FRAUD IN MEDICINE RESEARCH
Legal discovery process uncovered evidence of deliberate, systematic suppression of unfavorable Paxil research results.
MISLEADING PUBLIC
For 10 years, GlaxoSmithKline's marketing of the drug stated that it was "not habit forming". In 2002, the U.S. Food and Drug Administration published a new product warning about the drug, and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) declared GSK guilty of misleading the public about paroxetine on US television.
WHAT WAS THE SUPPRESSED INFORMATION
SSRI discontinuation syndrome Legal documents say that GSK suppressed or obscured suicide risk data during clinical trials of paroxetine. The fact that Paroxetine can cause intolerable withdrawal symptoms of the kind that could lead to dependence is enormously important to patients, doctors, investors, and the company. GlaxoSmithKline has evaded the issue since it was granted a license for paroxetine over 10 years ago.
Data from three GSK pediatric clinical trials on depressed children and adolescents show that Seroxat could not be proven to work for teenagers. Also, one clinical trial indicated that adolescents were six times more likely to become suicidal after taking it. The data was available even before Seroxat was first licensed in 1990, the Norwegian researchers found.
GSK SAID:
“We will review this study carefully. However, these conclusions in no way reflect the picture that has been built up about the benefits and risks of paroxetine in adults through an extensive clinical trials programme involving 24,000 patients.”
GSK CAUGHT
In early 2004, GSK (GlaxoSmitheKline) agreed to settle charges of consumer fraud for $2.5 million (a tiny fraction of the over $2.7 billion in yearly Paxil sales at that time). The drug generated about a tenth of GSK's entire revenue.
BRIBE TO RESEARCHERS
In early October, Nemeroff resigned from Emory amid revelations that he had received over $960,000 from GSK in 2006, yet reported less than $35,000 to the school. Subsequent investigations revealed payments totaling more than $2.5 million from drug companies between 2000 and 2006, yet only a fraction was disclosed.
SLEUTHS WHO EXPOSED GSK
BBC Panorama Programme:
"Secrets of Seroxat"
Panorama spoke to Dr David Healy, an expert on the drug who has had access to confidential Seroxat studies in the GlaxoSmithKline archives.
Panorama: The Secrets of Seroxat shown on BBC
Production team:
FYI
Suppressing negatives on a drug is on par with shipping salmonella contaminated peanut butter.
thanks, bfl
I am for reasonable regulation and this is one area where reasonable regulation is warranted. Some, if not many, pharmaceutical companies have been pulling this kind of thing for over 20 years with little or no accountability.
Some may lambast the “Comparative-Effectiveness Research” portion of the stimulus bill but I think more than ever it is needed (though it could and should have passed separately on its own).
If the University research groups that test and verify safety and efficacy of these drugs are being paid off by the pharm companies then who is left to protect the consumer and even medical professionals from receiving fraudulent data?
This is absolutely no different than the financial ratings companies on Wall Street being paid exorbitant fees to put triple A’s on securitized junk. There is no one guarding the hen house and no incentive to do so.
We ignore common sense pragmatism at our own peril.
It’s also known as SSRI withdrawal syndrome. Patients may need to be switched to generic Prozac, i.e. fluoxetine, and weened slowly off of it to avoid it. Fluoxetine is used because it has the longest half-life of all the SSRIs.
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