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Britain’s largest pharmaceutical company concealed clinical test results that suggested Paxil unsafe, says BBC

Wednesday, January 31, 2007 by: Beau Hodai
Tags: paxil, drug side effects, GlaxoSmithKline

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(NewsTarget) The BBC television series Panorama accused pharmaceutical giant GlaxoSmithKline this week of covering test results that link the antidepressant, Paxil, with increased suicidal tendencies in teens.

Paxil, Seroxat or Paroxetine, as the drug is generically known, is a selective serotonin reuptake inhibitor (SSRI), and has been available on the U.S. market since 1992. Paxil was once GSK’s most profitable product- grossing $1.9 billion in 2005 alone.

In 2004, GSK was faced with numerous class-action lawsuits in the both Europe and the United States on behalf of parents and children who claimed that the pharmaceutical company covered up evidence from clinical trials that suggested that Paxil was ineffective and even unsafe for juvenile use.

An internal document leaked earlier that year revealed that GSK had been warned about the potential ill effects of the drug’s application to children. The company was advised that it would be “commercially unacceptable” to release the data because it could “undermine the profile” of the drug.

As a result of a lawsuit filed by New York Attorney General Elliot Spitzer, GSK agreed to release all clinical data pertaining to the antidepressant and pay $2.5 million in restitution.

Panorama also claimed that GSK utilized ghostwriters to skew the reports of ‘independent’ academics.

Child psychiatrist Dr. Neal Ryan of the University of Pittsburgh, was one such ghostwriter employed by GSK. Study 329 was one of several studies conducted on Paxil between 1993 and 2003. Dr. Ryan was one of the co-authors of the study.

Study 329 revealed that, out of 190 patients between the ages of 12 and 18 years, 11 children on Paxil displayed elements of suicidal behavior, versus only two on placebo.

“Even when they have negative studies that show that this drug Seroxat is going to harm some kids they still spin that study as remarkably effective and safe for children,” said Karen Barth Menzies, a partner in the law firm of Baum Hedlund, representing several families in a U.S. class action lawsuit against GSK.

Menzies provided legal council, pro bono, to Christopher Pittman, who, in 2005 at age 12, killed both of his grandparents while under the influence of Zoloft (Sertaline, manufactured by Pfizer), another SSRI antidepressant.

“Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results,” read an internal GSK email discovered amongst the thousands of documents released by GSK pursuant to the 2004 Spitzer settlement. “Essentially, the study did not really show it was effective in treating adolescent depression, which is not something we want to publicize,” said the email.

In a press release Monday, GSK said: “In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients, including those under the age of 18, who suffer from depression and we refute any allegation that we have failed in this duty.

“GSK utterly rejects any suggestion that it has improperly withheld drug trial information. Results from its pediatrics studies were documented and submitted to regulators in accordance with regulatory requirements.”

“This kind of scientific fraud is routine,” said Mike Adams, author of"Natural Health Solutions."

"Drug companies engage in censorship, bribery, corruption, fraud, suppression of negative studies and all varieties of unscrupulous tactics to prevent the public from knowing the truth. I’ve documented numerous examples in my book that show both drug companies and the FDA engaging in deliberate scientific fraud,” said Adams.


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