Indecisive over Avandia, FDA risks lives

The FDA is at it again.  The bungling agency’s primary responsibility is to ensure that prescription drugs, like Avandia, are EFFECTIVE and SAFE.  Are we asking too much for an agency that is essentially the DMV with doctors?  I think so. The FDA was built on the noble premise that corporations are honest and forthcoming with their information.  And like small town folks that go to the big city for the first time, the FDA gets taken for all their worth. The unfortunate part is that they keep going back for more.

I sat down on Saturday morning with my coffee and New York Times and right on the front page was an article that should have shocked me but didn’t. The article on the front page described a “fierce debate within the [FDA]” concerning whether or not the prescription drug Avandia is safe. For those of you that don’t know, Avandia is a drug used to treat type 2 diabetes by lowering the amount of sugar in the blood. According to the article, there seems to be some sort of civil war within the FDA where one faction wants to recall Avandia and another that thinks the drug should remain on the market.

Type 2 diabetics already have an increased risk of developing cardiovascular disease. Avandia received black box warnings about the increased risk of heart attack 8 years after it was approved in 1999. That is 8 years of type 2 diabetics suffering from deadly heart attacks that may have been prevented if they never received Avandia.  The question is why would the FDA allow this drug to remain on the market when it increases the risk of heart attack in an already susceptible population? Nobody seems to know the answer to this question. Avandia is not unique and, as the New York Times article reports, there is a drug within the same family called Actos that seems to have better safety record.

Is there any good news from this?  Yes. The good news is that because of this controversy doctors started to abandon the product. I am sure that more people will stop using Avandia after this article on the front page of the New York Times. The bad news is that more people will die while the FDA engages in a “fierce debate” with itself. More bungling from an agency charged with keeping us all safe from the bottom line interests of large corporations.

If your where injured by Avandia write your representative.