Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official

Yep it’s official, GlaxoSmithKline failed you and me by hiding damaging data from Seroxat drug trials.

Naughty Glaxo.

Naughty, naughty Glaxo. There – you’ve been told off – now go and sit in the corner.

And that’s it. That’s about all that is going to happen to Glaxo – a bit of a telling-off.
After a four-year investigation and examining 1 million pages of evidence, the UK’s Medicines and Healthcare products Regulatory Agency has decided not to pursue criminal charges against the drugmaker, although the agency did chastise Glaxo for failing to release more quickly clinical trial data about suicidal risk in youngsters.

The prospect of obtaining a criminal conviction wasn’t “realistic,” because the legislation in force in 2003 – when the investigation began – wasn’t clear enough, especially concerning the disclosure of data and off-label use, the MHRA said in a statement. Glaxo and individual Glaxo employees declined “invitations to attend interviews,” the MHRA says, but did provide three written witness statements – two on behalf of the drugmaker and one on behalf of an unnamed employee.

Glaxo provided the MHRA with data from clinical trials confirming that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat/Paxil, than if they received a placebo; and that Seroxat was ineffective in treating depression in kids. The probe began after disclosure that Glaxo withheld clinical trial info.

“I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients and should report any adverse data signals to us as soon as they discover them,” Kent Woods, MHRA’s ceo, says in the statement. “This investigation has revealed important weaknesses in the drug safety legislation in force at the time.”

Laws have subsequently been changed to require drugmakers to report adverse reactions in any clinical trial, though these rules don’t apply outside of Europe – and most of Glaxo’s Seroxat trials were conducted in the US. The MHRA plans to press for change in law in the UK and eventually Europe to force drugmakers to report adverse clinical data no matter where trials are conducted.

“Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards. I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsbility now needs to be insisted upon by the unambiguous force of law,” Woods wrote Glaxo CEO JP Garnier.

7 Responses to “Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official”

  1. squirrel Says:

    Totally disgusted ! There is no justice in this country, big money pharma can do whatever the please and get away with it.There is no one to protect us! and no one accountable!

  2. Lynn Says:

    This sounds like the crime “endangering the welfare of a minor”. There are laws on the books in the U.S which state that teachers and doctors have a legal obligation to report suspected chilld abuse. Someone such as these Glaxo people knowingly hurting children should and maybe could be considered a criminal by that standard. I’m sure some American lawmaker will pick up on that point if Senator Grassley and Dr. Glenmullen make enough noise. This has got to be considered a crime against children, no matter what the actual laws on the books were when it happened.

  3. Willow Says:

    It’s appalling. – As Squirrel says, “There is no justice in this country, big money pharma can do whatever the please and get away with it.There is no one to protect us! and no one accountable!”

    Members of the MHRA are useless at their supposed task. Many seem to have been in the pocket of the drug companies. The MHRA should be disbanded. Any replacement body should be forbidden by law from having the slightest financial connection with any of the drug companies.

    I believe that the drug-pushers (i.e. the doctors) should have their prescribing rights severely restricted. Prescription drugs do far far FAR more harm than good, especially anti-depressants and steroids.

  4. truthman30 Says:

    Its official ..

    GSK can commit corporate crimes and get away with it..
    (in the UK at least)

    What GSK has done by holding back the Seroxat suicide data is basically commit corporate manslaughter and possibly corporate murder..
    The MHRA and the UK government should be vehemently condemning these criminal actions and so should doctors, GP’s and psychiatrists…
    Just because there was no conviction here does not mean a crime of immense immoral and unethical magnitude was not commited…

    The MHRA are claiming “The prospect of obtaining a criminal conviction wasn’t “realistic,” because the legislation in force in 2003 – when the investigation began – wasn’t clear enough, especially concerning the disclosure of data and off-label use, the MHRA said in a statement”.

    I find this completely absurd and ridiculous, surely the MHRA would have known 5 years ago before they began this investigation that there was little chance of obtaining a prosecution if that was the law at the time? So to come out 5 years later and use this “loophole” to let GSK off the hook is an awfully pathetic and insulting excuse. A public apology to the families of the children who died from Seroxat would have been appropriate but GSK or the MHRA were never going to admit accountability (or liability) were they?

    The MHRA never had any intention of prosecuting GSK because prosecuting them for this would have meant instigating criminal charges at the highest executive level of GSK, including summoning the CEO and the executive board etc.

    JP Garnier serves on UK prime minister Gordon Browns “business council” , GSK is a UK industry cash cow through its influence in health, the NHS, stocks and shares etc. GSK pays licincing fees to the MHRA , which relies on the industry to pay its executive wages. Former employees of Glaxo work for the MHRA . The real reason why this investigation was never going to make it to a level of criminal conviction is the MHRA and the UK government knows better than to “bite the hand which feeds it”..

    It doesn’t seem to matter that the grubby fingers of the “hand” dabbles in fraud, corruption and the manslaughter of patients..
    As long as the other hand continues to “pass the buck”..
    Its business as usual..
    Corporations can kill kids and get away with it..
    What a a disturbing world we live in..

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