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FDA considers halting GSK drug Avandia safety trial

Posted April 19, 2010

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— The three-year debate about the safety of GlaxoSmithKline’s diabetes drug Avandia may be reaching a climax.

According to The Wall Street Journal, the U.S. Food and Drug Administration is “weighing whether to halt” the study. Such a decision “could also determine whether the drug stays on the U.S. market.”

In a letter sent to Iowa Senator Charles Grassley (R-Iowa), and reproduced at The WSJ Web site, the FDA Commissioner Margaret Hamburg said:

“FDA is concerned about the potential risk. In July, the Agency will present assessments of all available evidence on the cardiovascular safety of Avandia to a joint meeting of the Endocrinologic and metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This session will give a meaningful opportunity for all views to be heard and will lead to an assessment and decision by the Agency.”

Glaxo (NYSE: GSK), which maintains its U.S. headquarters in Research Triangle Park, has aggressively defended the safety of Avandia.

Grassley is among Avandia’s harshest critics.

The safety debate dates to 2007 when the risk of heart attack by Avandia users was stressed in a study. The FDA approved a trial comparing the safety of Avandia to another product called Actos.

“Some scientists inside and outside the FDA have said it is unethical to compare a drug with known cardiac risks with a seemingly safer alternative,” the WSJ said. “They also say Avandia should be pulled from the market.”

In a statement, GSK is quoted by the newspaper as saying that it "welcomes additional scientific information that could help guide decisions around clinical trials and ultimately patient safety."

14 Comments

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  • froggytroat Apr 19, 2010

    "Do you actually think they would push putting a drug on the market if it killed people?"

    Do you actually believe they wouldn't?

  • davidgnews Apr 19, 2010

    And remember, when the pharmco tells you their med was 70% better in tests with placebo, it worked _better than nothing_.

    Sometimes nothing can be a better alternative.

  • seankelly15 Apr 19, 2010

    timbo 2.0 - You have very little understanding of the issues with Avandia. The real issue is that the population that they tested excluded people with a history of cardiovascular disease. And, given the relationship between diabetes and cardiovascular disease this 'oversight' was major. Okay, fine; they didn't (or did) do it deliberately. But, when the independent research began to build, indicating a greater than expected death rate among cardiovascular patients taking Avandia, GSK did nothing other than to ask the FDA to keep the drug in production while they conducted the safety studies (studies that should have been done before bringing the drug into the marketplace).

  • davidgnews Apr 19, 2010

    "Do you actually think they would push putting a drug on the market if it killed people?

    Vioxx comes to mind. The problems were so egregious that it had to be pulled.

    Don't you think it would be very obvious if the drug was fatal and it would open that company up to untold litigation?"

    Not when congresscritters write legislation to keep them off the hook for lawsuits, which they've done.

  • timbo 2.0 Apr 19, 2010

    "Yes, if there is any way to do that without putting the company at too much risk of litigation."

    Well, I'm not sure how people who believe those companies will purposely kill people actually believe a politician has our best interest at heart.

  • kenshi Apr 19, 2010

    Timbo 2.0 said:
    "What experts? Don't you think the drug company has it's own experts?"

    Yes they do, and they are paid to support and sell products

    "Do you actually think they would push putting a drug on the market if it killed people?"

    Yes, if there is any way to do that without putting the company at too much risk of litigation.

    "Don't you think it would be very obvious if the drug was fatal and it would open that company up to untold litigation?"

    No, correlations between risk are sometimes very complex.

    "Do you think they sit in a room and say "You know, it's okay to kill several 100 people, as long as we can make 10 million dollars. Let's do it!!!?"

    yes, after having working in the pharmaceutical industry for 20 years, yes I do believe those conversations come up.

  • timbo 2.0 Apr 19, 2010

    "Timbo 2.0, Study a little history. Before the FDA came into being it was a regular occurrance that dangerous or completely ineffective drugs were sold to the public."

    Don't need to study history, as my statement doesn't contradict yours.

    Again, it appears the FDA is more concerned about politics, than to correctly evaluating drugs on the market.

    Otherwise, why are they sending letters to a congressman?

  • wildervb Apr 19, 2010

    "To be honest, I don't trust the FDA to scientifically evaluate drugs because they appear more concerned with political issues than good science and what's good for consumers."

    Timbo 2.0, Study a little history. Before the FDA came into being it was a regular occurrance that dangerous or completely ineffective drugs were sold to the public.

  • timbo 2.0 Apr 19, 2010

    "It's not different than a court case where a juror makes a decision based on evidence and testemony presented by experts."

    There's no parallel with a jury. There's no trial. Don't be absurd.

    What experts? Don't you think the drug company has it's own experts?

    Do you actually think they would push putting a drug on the market if it killed people?

    Don't you think it would be very obvious if the drug was fatal and it would open that company up to untold litigation?

    Do you think they sit in a room and say "You know, it's okay to kill several 100 people, as long as we can make 10 million dollars. Let's do it!!!"?

    I don't trust *any* politician with my health care; nor do I trust them to scientifically evaluate drugs that are on the market or going to market.

    To be honest, I don't trust the FDA to scientifically evaluate drugs because they appear more concerned with political issues than good science and what's good for consumers.

  • A_Patriot Apr 19, 2010

    Except that I would expect a bit of sense in the juror - I have no such expectations of Grassley.

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