Glaxo hides yet more trial data

I wonder, can you see a pattern forming here?

This time it’s not Seroxat but Avandia – read on from the Chicago Tribune:

GlaxoSmithKline PLC, Europe’s largest drugmaker, failed to properly disclose studies of Avandia, the diabetes pill linked to potentially deadly side effects, U.S. regulators said.

The violations “are serious and may be symptomatic of underlying post-marketing safety reporting failures,” the Food and Drug Administration said in a letter posted on its Web site. The agency said it was never told about nine studies, and an additional 11 weren’t included in required annual reports from 2001 to 2007.

Avandia sales plunged last year after a May 21 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks, prompting U.S. and European regulators to strengthen warnings on its prescribing information. The FDA found unreported research while inspecting paperwork at London-based Glaxo’s offices in Research Triangle Park, N.C., from August to November, according to the letter.

Meanwhile, Glaxo said 247 lawsuits have been filed in the U.S. over Avandia.

And just one other thing – I thought’d read somewhere that Glaxo proudly boasts it places all clinical trial data on the internet… well, almost all it seems.

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4 Responses to “Glaxo hides yet more trial data”

  1. ROGER GREINER Says:

    REQUIP HAS DESTROYED MY LIFE BY CAUSING ME TO HAVE UNCONTROABLE URGES TO DRINK ALCAHOL GAMBLE AND SPEND MONEY I HAVE BEEN IN PRISON 10 TIMES IN 3 YEARS AND LOST DRIVERS LICENCE MY HOME WIFE CHILDREN JOB
    I WAS A SUCCESFUL INS AGENT OF 30 YEARS DID NOT DRINK OR GAMBLE 1 TRAFFIC TICKET IN 20 YEARS WENT TO
    CHURCH 3 TIMES A WEEK GSK MUST PAY FOR THIS ROGER G

  2. Lynn Says:

    very nice

  3. truthman30 Says:

    The violations “are serious and may be symptomatic of underlying post-marketing safety reporting failures”

    Basically what the FDA are saying is GSK makes a habit of not disclosing information on its drugs after they are approved. (we have seen thats true with Myodil, Paxil and now Avandia)
    These drugs have caused much death and suffering to hundreds of thousands of people due to suppression of data, something GSK does a lot of according to the FDA..

    This is well beyond a pattern..
    This is complusive, intent and purposeful policy directed from the top down..

    One incident like this with one drug should be enough for the federal government, the FDA and the UK government and the MHRA to simply deny GSK and further drug licences …
    But no..
    They continue to pass drugs from a drug company which consitently fails to comply with the ethical, lawful and moral duties it is dutied to uphold..
    Unbelievable…


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