FDA Memo Blasts Diabetes Medicine Avandia

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As the mainstream media have gradually exposed the scandal of unpublished drug-risk studies (for example, the Celebrex/Vioxx affair), the dangerous drugsconcept of risk-to-benefit analysis has entered public consciousness. While consumers are aware that all prescription drugs come with risks, few know how to weigh these risks vs. the benefits. But we are less likely to take chances with our health when we are educated about the potential dangers of using prescription drugs.

Avandia, a widely prescribed diabetes medication, was scrutinized by two FDA drug-safety reviewers, Dr. David Graham and Dr. Kate Gelperin, who wrote an October 2008 memo (yes, over a year ago!) in which they concluded that Avandia posed serious risks. Graham and Gelperin’s memo stated there was “strong evidence that (Avandia) confers an increased risk of “heart attack and heart failure when compared with Actos.” The researchers estimated that Avandia caused 500 more heart attacks and 300 more cases of heart failure per month than did Actos. In 2007 Dr. Graham had urged an FDA panel to pull Avandia from the market, but the panel voted 22-1 to advise the FDA to allow continued sales of the drug.

Sens. Grassley and Baucus, who serve on the Senate Finance Committee, released the Graham/Gelperin memo as part of a report showing that Glaxo “knew for several years prior to this study that there were possible cardiac risks associated with Avandia.” The FDA appears to serve the interests of corporations whose fees fund the agency’s activities and who employ many former FDA staff members. The Grassley/Baucus report should galvanize every American into action. As we have often written here, the FDA cannot be fixed; it must be fundamentally reformed from the ground floor up.

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  • Susan

    And believe it or not, I already had heart failure when Avandia was prescribed to me for diabetes in approximately late 2003 or 2004. Fortunately, I was only on it for several months because I gained 23 pounds in less than 3 months while on that drug! I shudder to think that I was on a drug that could cause more heart problems.

  • Regina Griffith

    So where are the indictments? Doesn’t this constitute manslaughter, or did I miss something?

    More people are being murdered by the pharmaceutical industry with their accomplices at the FDA than by “terrorists.”

    How many deaths does it take before any of these people are arrested?

  • KAY EICHNER

    Dear Sirs,
    I am one injured by Avandia. Avandia disabled me in 2000. I suffered HF, MI, luing disfunction, and lymphedema in both legs. I have not worked since, I am a RN. I will do all I can to stop this drug, drug companies, and the FDA.

    Kay Eichner, MS, BSN

    • Hi Kay,

      Do you know which drug doctors have replaced Avandia with, now?

      Did you gain weight, too? My friend is now obese. Actually several are. She too has lymphedemia in her legs. She keeps telling her doctor it is the medication. She is on 13 drugs. Horrible. Yesterday she told me she was going off all of them. That is not a good thing at one time, but I believe one could safely say she is being poisoned within with that drug cocktail. Have you written your senator and rep about your concerns?

      What are drugs are you on now? What are you doing to help yourself?

      Melanie Fisher

      • KAY EICHNER

        HI MELANIE, JUST NOW FOUND YOUR POST. YES, I GAINED NEARLY 70 LBS. ACTOS IS BEING USED BY SOME BUT IT IS NOT SAFE NOR IS METFORMIN. I TOO WAS ON MANY MEDS AND QUIT ALL OF THEM EXCEPT MY BLOOD PRESSURE MED AND INSULIN. I WAS ON BOTH WHEN I WAS PUT ON THE AVANDIA. AND BOTH MEDS WERE INCREASED WHILE ON THE AVANDIA. CURRENTLY MY HEALTH IS NOT GOOD BUT I’M STILL ALIVE AND KICKING AS HARD AS I CAN. LOL. I WISH YOUR FRIEND WELL AND HOPE SHE GETS IN ON THE CLASS ACTION CASE.

  • topogiego

    They should BAN this drug. It darn near killed my son…and I could shoot the doctor that gave it to him…giving him a taste of his own drug. Let him lay in the hospital with severe chest pain, instead of our children.

  • By necessity I started to research the Web in 2000 after being diagnosed with prostate cancer. To my amazement, disgust and then understanding, I discovered that we suffer a severely restrained medical system primarily focused at putting out the fire in our health house while having no real concern or training for preventing said fires from developing in the first place. I also discovered that a lot of excellent medical resources and treatments go by the way side because they do not fit the economic template of our medical/pharmaceutical system.
    The FDA has sold its sould to the system in order to survive. Not pretty, but necessary for its existence.
    Our health care is crippled by design… Who wants or could fix it? Very tough question

  • Allodds

    When compared with all the recent new coverage of the Toyota recalls, it leaves me wondering why the media does not make a big deal out of the Pharma failures ? Actually, this will never make it to mainstream media because the Pharma industry is one of the biggest funders of media. So, most Americans will never learn about this as they are kept mesmerized by the entertainment industry. The Big Pharma also heavily funds the elections and the Congress here, so there will never be any indictments. We, the democratic citizens of the largest democracy in the world, must simply live (or often times, die) to learn.

  • Thank you for publishing this story, along with the link to Senator Grassley’s work. He’s done a lot to expose fraudelent research and marketing of psychiatric drugs as well. Wish there were 99 more like him in the U.S. Senate…. Maybe Americans would finally wake up to the scam behind so much of our “medicine.”

    Duane

  • Sorry to hear that Melanie.

    I feel terrible for those who have use this drug and has gotten worse. I hope the victims will have justice and those guilty will be put behind bars.