Glaxo Faces Criminal
Action In UK Over
'Suicide' Pills - Paxil

From Dr. Ann Blake Tracy, PhD
This is a newsletter that just went out to our Drugawareness E-group and I knew you would all be interested in this late breaking news on the antidepressant front as well.
Also, if any of you carried the story last Wednesday on Prozac being good for children you should know that both Dr. Emslie and Dr. March have major confilcts of interest and therefore, never should have been allowed to do this study. On top of that, in reading the results of the study there was NO evidence that Prozac was beneficial unless you call what they found as beneficial: a DOUBLING of the suicide rate and a suicide attempt rate FIVE TIMES GREATER on Prozac than placebo. So, I ask again, where was the evidence of any benefit? And why was none of that reported to the public?
For additional information contact:
Ann Blake Tracy, Ph.D. Executive Director, International Coalition For Drug Awareness Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio tape on safe withdrawal: "Help! I Can't Get Off My Antidepressant!"
Order Number: 800-280-0730
Office Number: 801-282-5282
Cell: 801-209-1800
Four days ago I sent you the news that the NY Attorney General had filed a suit against GlaxoSmithKline over Paxil and in that message I made the following statement: "United Kingdom has been considering criminal charges against this company for almost a year for this same exact reason. With this action by the state of New York will we see them now act on that as well?"
And today we have that answer in VERY bold headlines stating it the way it is: "Glaxo may face prosecution over antidepressant" or "Glaxo faces criminal action in Britain over 'suicide' pills" - exactly what I have said for 15 years, although "murder/suicide pills" may have been a better fit.
Paxil was the worst of the SSRIs until Celexa hit the market - as if you can pick one out as one's worst poison? They all work the same way and they all produce the same results - some may take a day or two longer is all. But I predict that Effexor will be the next to bite the dust because it is such a nasty drug. When they marketed it as "Prozac with a kick" they were not kidding!
Anyway I don't think anyone would want to be in the shoes of Glaxo spokeswoman Mary Ann Rhyne right now. The end of May Italian police announced they want 4000 doctors and 273 Glaxo employees put on trial. Then the NY Attorney General last week, Canada issued their strong warning against this group of drugs a day or two later, and now Britian plans to file criminal charges. Talk about a public relations nightmare! They are being hit from the four corners of the earth!
Considering how many lives I have seen lost to this drug, or lives destroyed as a result, or people addicted to it in terrible withdrawal, I have no compassion for Glaxo. The old saying, "You reap what you sow" certainly applies in this case.
Ann Blake Tracy, Ph.D.
Executive Director, International Coalition For Drug Awareness Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio tape on safe withdrawal: "Help! I Can't Get Off My Antidepressant!"
Order Number: 800-280-0730
Glaxo Faces Criminal Action In Britain Over 'Suicide' Pills
By Paul Durman and Dominic Rushe
Times Online - UK
GLAXO SMITH KLINE is facing a potential criminal prosecution for allegedly failing to inform British health regulators about the suicide risks associated with Seroxat, its blockbuster anti-depressant. Officials at the Medicines and Healthcare Products Regulatory Agency (MHRA) launched an investigation into Glaxo because of concerns that Britain's biggest pharmaceutical group had withheld important data from clinical trials.
This showed that Seroxat could cause an increased risk of suicide and " self-harm" if prescribed to depressed teenagers.
The MHRA and the Committee on Safety of Medicines only received full details of the trials in May last year. Within two weeks, the MHRA announced a ban on giving Seroxat to children under 18 - the first regulator in the world to take such a step. Shortly afterwards, the US Food and Drug Administration issued similar, though less categorical, advice to doctors.
The MHRA investigation is expected to report its findings shortly. This weekend the MHRA said it "treats very seriously any failure to comply with the law. Last year, the MHRA announced that it would investigate Glaxo to make sure the company had complied with its legal obligations under UK and European law."
Drug companies are obliged to report new evidence that changes the balance of risks and benefits of using their products.
Depending on its findings, the MHRA could choose to prosecute either Glaxo as a company or go after named individuals. If found guilty, the penalties could include fines or imprisonment.
The MHRA action comes when Glaxo is still reeling from allegations last week that it had "engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose" important information about the safety and efficacy of Seroxat, which is known as Paxil in America. The company must defend itself against a lawsuit from Eliot Spitzer, the New York attorney-general who first came to prominence after taking on the abuses of Wall Street banks during the technology boom.
Jean-Pierre Garnier, Glaxo's chief executive, insisted the firm had provided regulators with all trial data. "We are a high-integrity company," he said. " We know what the rules are and we follow them. We have a policy of publishing our negative data to the authorities."
The British case rests on some of the same evidence as that of the New York lawsuit.
Garnier said it could be dangerous to change medical advice based on a single clinical study. "Sometimes you have to wait for all studies to come in before you have some sort of conclusion.",,8209-1135320,00.html
Glaxo May Face Prosecution Over Anti-Depressant
LONDON (Reuters) - GlaxoSmithKline may face prosecution for allegedly not informing health authorities about suicide risks associated with its antidepressant Seroxat, The Sunday Times has reported.
Europe's largest drugmaker is already facing charges by New York Attorney General Eliot Spitzer over the use of the drug, sold in the United States as Paxil, on children.
The Sunday Times said the Medicines and Healthcare Products Regulatory Agency (MHRA) had begun an investigation because of fears that Glaxo held back important information from clinical trials.
The information indicated that Seroxat may cause a greater risk of suicide and "self-harm" if given to depressed teenagers, the paper said.
A spokeswoman for MHRA -- the government's watchdog on drug safety -- confirmed it was investigating Glaxo on the Seroxat issue.
"The MHRA treats very seriously any failure to comply with the law. Last year, MHRA announced that they would investigate (Glaxo) to establish whether they had complied with their legal obligations under UK and European law," she said.
"The investigation is ongoing and will report shortly," she added. She did not elaborate.
A Glaxo spokesman declined to comment.
The use of Seroxat and other similar drugs to treat children is under medical scrutiny because of worries about higher suicide risks, leading U.S. and British regulators to issue warnings against using it for patients under the age of 18.
Spitzer filed a lawsuit against Glaxo on Wednesday over charges that it fraudulently concealed studies showing that the antidepressant may not work when used to treat children and could lead to suicidal behaviour.
"The company suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increase risk of suicidal thinking and acts," Spitzer said. This amounted to "repeated and persistent fraud," he said.
Glaxo spokeswoman Mary Ann Rhyne said on Wednesday that the company disseminated information about all its trials either in medical journals or at public scientific meetings as well as to regulatory agencies.
The Sunday Times said the MHRA may choose to prosecute Glaxo or go after specific individuals at the company.



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