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Saturday, March 14, 2009

Fraud in Medical Research - GSK Bribes Exposed

Source: Free Republic

Hat tip: The Truthman



FRAUD by Multinational pharmaceutical giant: GSK GlaxoSmithKline

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 (GlaxoSmithKline) 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


1] European Medicines Agency's (EMEA)
2] Committee for Medicinal Products for Human Use (CHMP)
3] U.S. Food and Drug Administration (FDA)
4] International Federation of Pharmaceutical
5] Manufacturers Associations (IFPMA)
6] Medicines and Healthcare products Regulatory Agency (MHRA)
7] Mental health charity Mind


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:



Reporter: Shelley Jofre
Producer: Ed Harriman
Director Gerry Troyna
Assistant Producer: Sarah O'Connell
Assistant Producer: Calum Walker
Editor: Mike Robinson

Comment left by reader:

"Suppressing negatives on a drug is on par with shipping salmonella contaminated peanut butter." Source





Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

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