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View Diary: Did GlaxoSmithKline know Avandia could cause heart trouble? (62 comments)

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  •  It would be helpful to have just a tad more (2+ / 0-)
    Recommended by:
    JeffW, greengemini

    information . . .

    It also contains a study conducted by FDA reviewers David Graham and Kate Gelperin, which found Avandia is linked to 500 more heart attacks and 300 more heart failures than its main competitor.

    For example, if this drug was given to 100 million people v. 100 thousand for the other drug, and saved the lives of many of these, the deaths may be "worth the price" as Madeline Albright would say . . .

    Or, we could just shut down the entire health care enterprise based on accumulating evidence that it does more harm than good . ..

    •  Avandia (3+ / 0-)
      Recommended by:
      gooderservice, deMemedeMedia, majii

      Is used for type 2 diabetes.  There are safer drugs on the market and people with type 2 diabetes can improve their health by exercise and changes in their diet.  Avandia didn't save more lives.

      •  It seems like the bigger problem here is (1+ / 0-)
        Recommended by:
        majii

        that the company who's selling the product is expected to report on problems with the product . . . that smacks of huge conflict of interest concerns and a simply unworkable way of doing things.

        Of course, since the Republicans ensure that "the public" (aka the FDA) is not sufficiently funded to do the testing, it is not clear how to improve the situation.

        •  Testing costs hundreds of millions of dollars. (1+ / 0-)
          Recommended by:
          greengemini

          The FDA requires companies to use third party research organizations to do the research. All results, good or bad are to be made accessible to the FDA and the public.

          There are many gray areas in this process.  Even independent organizations can be reluctant to expose the sponsors of their research. Studies are designed to accentuate the advantages of the drug, not the deficiencies. This said, the system works quite well.

          There will always be errors. Some side effects can only be detected when you have literally millions of people using a drug. 500 heart attacks sounds like a huge number, but it is a tiny, tiny fraction of people using Avandia and people with type 2 diabetes are a group at high risk of heart attack.

          I'm not trying to defend Glaxo. If they had this information and withheld it they should be punished severely, both criminally and civilly.

          God has no religion. - Gandhi

          by OIL GUY on Tue Feb 23, 2010 at 04:12:07 PM PST

          [ Parent ]

          •  You're saying after market studies (0+ / 0-)

            cost hundreds of millions?  That's hard to believe.

            "Centrist" refers to a politician who takes money from corporations, and then votes for those companies to become richer.

            by gooderservice on Tue Feb 23, 2010 at 04:54:36 PM PST

            [ Parent ]

            •  The FDA requires extensive 'Phase 4' studies. (0+ / 0-)

              These are done after the drug is on the market. They involve tens of thousands of patients and thousands of physicians. They also enable the pharma to establish the safety and effectiveness of its new drug on a larger population.

              God has no religion. - Gandhi

              by OIL GUY on Wed Feb 24, 2010 at 08:02:17 AM PST

              [ Parent ]

      •  Exactly. (2+ / 0-)
        Recommended by:
        greengemini, majii

        Type 2 can be pretty much cured by proper diet. The Zone diet, for one, not only helps with cardiovascular health, but it "cures" diabetes as well.
        People are too anxious for a quick fix. They don't want to have to eat better, exercise etc if they can take a pill. Even if that pill might kill them.

        Electing conservatives is like hiring a carpenter who thinks hammers are evil.

        by MA Liberal on Tue Feb 23, 2010 at 04:02:33 PM PST

        [ Parent ]

        •  It's not that simple. (4+ / 0-)
          Recommended by:
          VA Breeze, JeffW, greengemini, majii

          Diet and excercise can improve type 2 diabetes. That works for some people, but not everyone. Diabetes is a dangerous disease and it is vitally important to get a person's blood glucose levels under controll through whatever means are effective. In this case there are other drugs - particularly metformin - which are as effective as Avandia and have been used safely for a number of years. Metformin is also much less expensive as it is a deneric drug.

          God has no religion. - Gandhi

          by OIL GUY on Tue Feb 23, 2010 at 04:17:39 PM PST

          [ Parent ]

          •  Deneric drug? Sounds cool ;) (0+ / 0-)

            "Centrist" refers to a politician who takes money from corporations, and then votes for those companies to become richer.

            by gooderservice on Tue Feb 23, 2010 at 04:55:49 PM PST

            [ Parent ]

          •  Sorry to disagree... (0+ / 0-)

            ...but diet has everything to do with Type 2.
            Consume too many high glycemic carbohydrates and you become insulin resistant and end up, in many cases, with diabetes.
            Americans just like their drugs so they don't have to think about diet. It's why so many take that little "Purple Pill" for "Acid Reflux Disease." They don't care as long as they can take a pill, even if it might screw up their system in the long run, or why so many obese people (and I'm not talking about people who are grossly overweight, like 600 lbs, but more like those who are just above the 100 lb overweight threshold) decide to cut out their stomachs rather than go on a diet.
            Everyone wants a quick fix.

            Electing conservatives is like hiring a carpenter who thinks hammers are evil.

            by MA Liberal on Wed Feb 24, 2010 at 01:01:19 PM PST

            [ Parent ]

        •  Please share the data that says that. (1+ / 0-)
          Recommended by:
          JeffW

          Just one link would be great.

          "Centrist" refers to a politician who takes money from corporations, and then votes for those companies to become richer.

          by gooderservice on Tue Feb 23, 2010 at 04:55:20 PM PST

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          •  Read up on the Zone Diet (0+ / 0-)

            The first book is especially good in laying out, in simple terms, how it works to lower cholesterol, prevent heart attacks and control, and in many cases cure, Type II diabetes.
            It really is fascinating.

            Electing conservatives is like hiring a carpenter who thinks hammers are evil.

            by MA Liberal on Wed Feb 24, 2010 at 01:04:45 PM PST

            [ Parent ]

        •  Well, no. (1+ / 0-)
          Recommended by:
          gooderservice

          Usually (at least in my communities - Indian), it's diagnosed too late for prevention.  So much damage is already done that diet and exercise won't control it anymore.  To have a situation in which Type II "can be pretty much cured by proper diet," we'd have to have a complete overhaul of 1) diagnosis and prevention within the medical fields; and 2) a complete overhaul of this country's approach to making healthy foods accessible to the poorest.  Not gonna happen; everyone else is too comfortable with the way it is.

          Authentic Native American silverwork, jewelry, photography, and other art here.

          by Aji on Tue Feb 23, 2010 at 05:46:28 PM PST

          [ Parent ]

          •  That's true too (0+ / 0-)

            It would be great if our medical system would work on proper diet instead of relying on pills. We should have a system where we can catch things before they become a real problem.
            Unfortunately, in our system, they only know drugs and surgery.

            Electing conservatives is like hiring a carpenter who thinks hammers are evil.

            by MA Liberal on Wed Feb 24, 2010 at 01:02:44 PM PST

            [ Parent ]

    •  NYT: GSK allegedly threatened doctors... (7+ / 0-)

      This was the page 1 headline story in the NYT on Feb. 19th. Here are the last paragraphs. Talk about burying the lede...

      The Senate inquiry concludes that the company threatened doctors who suggested in public that Avandia might have serious risks.

      In 1999, for instance, Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania.

      GlaxoSmithKline said that it “does not condone any effort to silence” scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation “could have been handled differently.”

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