Hogan's Alley

Tuesday, May 22, 2007

Another Failure By The FDA

The New England Journal of Medicine has published a meta-analysis of the available data linking the diabetes drug Avandia and myocardial infarctions, or heart attacks. Its authors conclude that the evidence of a connection is significant enough to require a total review and new studies. They conclude, "Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes."

This follows on similar findings for the drugs Vioxx and Celebrex, which are used for osteoarthritis.

In all these cases our beloved Food and Drug Administration approved these drugs as safe and effective for human use, and they were wrong. What is going on at FDA? Is this just another example of the inability of Bush appointees to run agencies well? Are they underfunded and understaffed? Have they suddenly decided to hire idiots with advanced degrees?

I don't know the answer, but I'm beginning to take it personally. I have taken all of these drugs. So far I have not had a heart attack. I count myself as lucky.

But I shouldn't have to depend on luck. I should be able to trust that my government, having decided to monitor and control the introduction and use of all medicines, would not leave me so recklessly unprotected. This must become a priority for the Congress. We can not afford to wait for post-Bush improvements. Lives hang in the balance.

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