Senate Report Ties Diabetes Medicine to Heart Attacks

The discussion of the Linus Pauling vitamin C/lysine invention for chronic scurvy

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Ralph Lotz
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Senate Report Ties Diabetes Medicine to Heart Attacks

Post Number:#1  Post by Ralph Lotz » Sat Feb 20, 2010 12:30 pm

(Feb. 20) -- The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, a Senate committee report released Saturday says......

http://www.aolnews.com/health/article/s ... 2F19366673
"Unless we put medical freedom into the constitution...medicine will organize into an undercover dictatorship..force people who wish doctors and treatment of their own choice to submit to only what..dictating outfit offers." Dr. Benjamin Rush

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Re: Senate Report Ties Diabetes Medicine to Heart Attacks

Post Number:#2  Post by godsilove » Sat Feb 20, 2010 4:54 pm

Ralph Lotz wrote:(Feb. 20) -- The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, a Senate committee report released Saturday says......

http://www.aolnews.com/health/article/s ... 2F19366673


Steve Nissen (who was one of the first to draw attention to the cardiovascular risk of Vioxx) published a meta-analysis of Avandia trials in 2007 showing that there was an increased risk of MIs. GSK, of course, denied the conclusions at first but a later trial to evaluate this showed a non-significant increase in MIs, and a significant increase in heart failure. I'm curious as to how early GSK allegedly knew of a link.

I think the main problem here is that Avandia was approved without showing that it actually improves survival or reduces the rate of clinically important outcomes. The FDA needs to re-evaluate its policies as far as acceptance of surrogate outcomes is concerned - especially in areas where there are already established treatment options. This should have been the case with Avandia, and also with Zetia. Merck is running a trial that will evaluate cardiovascular outcomes, but the results of those will only be out in a few years' time - in the meantime, Zetia is being fairly widely prescribed without any evidence that it is reducing the risk of cardiovascular events. There are some cases where surrogate outcomes may be acceptable, but I think as far as diabetes meds are concerned, trials for new drugs should be designed to allow for an evaluation of cardiovascular outcomes and diabetes-related complications. It would make trials a lot more expensive, but considering the possible rewards for a drug that meets such endpoints, it's only fair.


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