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FDA may screen diabetes drugs more carefully

Last Wednesday, an FDA panel voted overwhelmingly (14-2) that new diabetes drugs in the pipeline should undergo longer studies to confirm they do not increase the risk of heart problems.

Remember GlaxoSmithKline's Avandia nightmare from last year? This diabetes drug was approved by the FDA in 1999, but wasn't slapped with a black box warning for potential heart risks until late in 2007. The FDA currently doesn't screen diabetes drugs for associated heart risks -- it currently looks at a drug's ability to lower blood sugar.

As the famous Avandia whistleblower, Dr. Steven Nissen, recently pointed out, this criterion is of little value if drugs simultaneously increase heart problems.

Thank you Dr. Nissen for standing up to the FDA and Big Pharma regarding Avandia, and now future diabetes drug approvals! I just love this guy. I blogged about the unfolding Avandia story last year over at The Diabetes Blog -- Dr. Nissen stuck his neck out and won.

The FDA tends to listen to its panels -- I hope they follow the advice of this one.  A majority of the panel said drug companies could begin safety testing before they submit to the FDA, then finish studies after drugs hit the market. Makes sense to this layperson. These longer studies take an estimated 5-7 years -- if there is a heart risk with a new drug, I sure wouldn't want it out on the market before a long term study has even begun.

As Dr. Clifford J. Rosen shared in the New England Journal of Medicine during the Avandia mess last August, "with regard to diabetes drugs, we are certain to be in the same position five years from now that we are now: we will again find ourselves in possession of a new wonder drug that is designed to treat a devastating chronic disease but that may do more harm than good." Hey FDA, no more wonder drugs without a careful look at heart risks and lifespan, okay? I don't care how much it costs Big Pharma.

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