Malani on the FDA and Avandia

Avandia's Exception
Anup Malani
Forbes.com
July 27, 2010

The FDA's experience with Avandia is quite a saga. Two years ago a prominent study revealed that Avandia, a drug used to control blood sugar in diabetics, posed a risk of heart attacks. Then it came out that Avandia's producer, GlaxoSmithKline, hid other data about the risk of heart attacks from the FDA. Two weeks ago an advisory committee of the FDA voted to keep Avandia on the market despite its side effects, evoking sharp reactions from consumer groups and academics. And last week it came out that one of the advisory committee members was a paid speaker for GlaxoSmithKline and another was a paid speaker for its competitor Takeda Phamaceuticals. The FDA knew this but did not inform the committee.

You might naturally think this controversy is solely about misbehavior by drug companies, but there is a bigger issue lurking underneath. This issue has implications not just for diabetes medications but also for all drugs that the FDA regulates: Should the FDA evaluate a drug by comparing it with other drugs that serve the same purpose or should it be compared to a placebo, such as a sugar pill? The answer affects the price you pay for medications, whether you will have a choice of drugs to treat your sickness and how long it will take to develop new treatments.

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