US senator seeks FDA probe of Glaxo’s Paxil data – was safety information withheld in the USA?

U.S. Sen. Charles Grassley asked U.S. regulators on Thursday to investigate whether drugmaker GlaxoSmithKline Plc withheld data about a risk of suicide linked to its anxiety disorder drug Paxil.

Grassley, a Republican from Iowa, said in a letter that a British regulatory agency had found Glaxo knew Paxil was associated with a higher risk of suicidal behavior in adolescents as far back as 1998.

“I would like you to take a look at the information that agency gathered and determine if the company has withheld safety information here as well,” Grassley wrote in the letter to the heads of the U.S. Department of Health and Human Services and the Food and Drug Administration.

Grassley also asked the FDA to review a report by a Harvard psychiatrist who has submitted information as part of several lawsuits. The report found Glaxo “had to know of Paxil’s suicide risk when it sought FDA approval for the drug,” a statement from the senator said.

The senator has long been critical of both the FDA’s and the pharmaceutical industry’s handling of drug safety information, digging into various cases since Merck and Co Inc’s withdrawal of its pain drug Vioxx in 2004.
Antidepressants, including Paxil, have stirred particular concern after studies showed an increased risk of suicidal thoughts and actions in children and young adults taking the drugs. The FDA called for new warnings in 2004.

Paxil, known generically as paroxetine hydrochloride, is a type of antidepressant known as a selective serotonin reuptake inhibitor and is sold in Britain as Seroxat.

FDA spokeswoman Sandy Walsh said the agency would review Grassley’s request and respond to him.
Grassley asked Glaxo in February when it knew of Paxil’s risks. Glaxo has said it provided the FDA a variety of information on suicidal risk in Paxil patients.

“We do feel like we gave Senator Grassley a full and fair response,” company spokeswoman Mary Anne Rhyne told Reuters on Thursday.

3 Responses to “US senator seeks FDA probe of Glaxo’s Paxil data – was safety information withheld in the USA?”

  1. truthman30 Says:

    I sincerely hope that the American authorities have bigger balls than the MHRA in dealing with this.

    Not to long ago the MHRA CEO Kent Woods sent JP Garnier a rather scathing letter about the investigation into GSK suppressing data on Seroxat suicidality. He didn’t even get a personal reply back, he got a corporate mantra which bordered on being a cheeky “piss off” …If i was Kent Woods I would have been highly insulted, but then again I am not Kent Woods, and my salary does not depend on keeping the rabid pharmaceutical dogs well fed and happy…

    Personally I think GSK was not prosecuted in the UK because it is a UK based stock company, with the power it yields in government and UK institutions and markets it was never going to happen. I sincerely hope the situation in the US is different, and I believe that it could well be.

    What it boils down to is, if a UK multinational bases itself in the UK and brings in huge revenues to the UK economy, then it’s ok to commit corporate crime and get away with it. Would Pfizer , and American monolithic monster of pharma get away with such dispicable crimes against UK citizens? I doubt it..
    Would Lundbeck, A smaller danish based Pharma company get away with it? I doubt it..

    Doctor Joespeh Glenmullen ( An esteemed and highly respected Harvard psychiatrist) has been saying for years that GSK doctored the original Paxil data to show the drug in a more favourable light. How long does it take before people begin to listen? How many people have to die and suffer the consequences of being prescribed a defective and dangerous drug like Paxil before something will be done?

    GSK would never have the integrity to pull any over their drugs which cause harm, they have an apparant and constant policy of denial, and it is a policy which works for them because they continue to get away with crimes that would be unacceptable in any other situation. It is therefore up to the regulators and governments to make sure that dangerous drugs like Paxil do not make it to the market. And when they do slip devously through the net, it is up to teh regulators to address the situation. Unfortunately we have spineless regulators like the MHRA whose own leadership is absolutely out of touch with patients concerns. They too operate within a system of denial , for their ultimate fear is being held accountable and responsible for the Seroxat Scandal.

    Senator Grassely is a brave man, for the forces of which he is questioning are very sinister and ruthless. These forces hold profit above all else on their altar of devotion and worship. With this being the ultimate corrupter of ethics , humility and humanity and with this being the beast which he is challenging, Senator Grassely is to be admired.

    Senator Grassely is threading on the grounds of “the constant gardener”… I wish him luck ..🙂

    • Andrew Harris Founder of www.triamazon.com Says:

      URGENT…CALL THE FBI AND FORWARD ON THIS INFO
      Kent Woods, is the head of the MHRA (The regulatory body for all of the large Pharmaceutical companies.)
      And yet Kent Woods had previously worked for GlaxoSmithKline (a major Pharmaceutical company) for 27 years.
      SURELY THIS IS A CONFLICT OF INTEREST?
      THIS WAS NEVER DISCLOSED TO SEROXAT INVESTIGATIONS
      See what Paul Flynn M. P. for Newport West, has to say about it by visiting this link http://www.paulflynnmp.co.uk/seroxat04.htm

      ALSO TELL THE FBI ABOUT THIS OTHER MUPPET BELOW
      The Chief Medical Officer (CMO), Professor Sir Liam Donaldson, is the UK Government’s principal medical adviser and the Un-professional head of all medical staff in England.

      Liam Donaldson CMO approved Mercury & Sualene “banned substance” to be in the injection to be given to pregnant women & children, he is also the chair of the WHO (World Health Organization).

      For further information please visit http://tpuc.org/taxonomy/term/5

  2. Lynn Says:

    Amen, amen.


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