The saga continues.

Theresa GarneroBy Theresa Garnero, APRN, BC-ADM, MSN, CDE

Who is being harmed by Avandia?

If you listen to the arguments of Dr. Nissen, the Food and Drug Administration (FDA), and the late night attorney ads, you may think Avandia has hurt lots of people. After all, it has to be serious if the FDA is involved, as their mission is to protect and promote your health.

The concern about Avandia's potential harm made headlines after the New England Journal of Medicine (NEJM) published a meta-analysis on the topic. Even the authors admitted that small changes in the classification of events, like self-reported as opposed to clinically-observed chest pain (angina), would have dramatically changed the statistics and thus outcomes of this retrospective study. Maybe the problem was that GlaxoSmithKline, the makers of Avandia, did too good of a job studying it extensively. It is rare to have such a database of accessible pharmacological research from which to do a meta-analysis. Maybe that is why we don't see similar articles on the safety of other oral diabetes drugs that may cause heart issues for high-risk populations (especially given new research about the risk when glucose levels fall too low).

The media took the Avandia meta-analysis results and blew them out of context. People ditched their Avandia without consulting their healthcare professionals, as witnessed by those of us in the trenches of diabetes care and education.

Avandia is risky for a small sub-group of people. So is over-the-counter aspirin. Does that mean we should throw them away? No! People need to be informed consumers and not make decisions based on fear. This is not to minimize the impact on the families of those who had adverse outcomes.

The truth is, Avandia helped a lot of people. Once the weak statistics hit the media, the concern for safety actually hurt many more than it helped. Countless people who were in control of their diabetes suddenly stopped taking their Avandia, or the combination drugs containing it (Avandamet and Avandaryl). They'd come in saying, "I stopped my Avandia—it was bad for my heart," only to have their glucose values return to a dangerously high level, ironically putting them at risk for a heart attack.

What happened to the utilitarian approach to medicine—do the most amount of good for the most amount of people? Isn't that why the FDA exists? Extensive research goes into each drug to establish a track record of safety and effectiveness. By the time a drug is born, an average of 12 years drug development and $800 million are invested in the process. Out of every 5,000 compounds evaluated in pre-clinical testing, only 1 makes it from the lab to the pharmacy. Granted, it isn't a perfect system.


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Last Modified Date: June 19, 2013

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