NRC for Women & Families responds to the FDA’s decision on Avandia for diabetes

Diana Zuckerman, President of the National Research Center for Women & Families

September 23, 2010

In an ideal world, this compromise decision might work, but the FDA does not have an impressive track record for restricting access to prescription drugs.  And physicians don’t have a great track record of advising patients about the risks and benefits of treatment alternatives – and many diabetes patients will not be able to understand their doctors’ explanations, especially those who are very elderly.  This is a problem of communication on the part of the physicians as well as limitations in understanding on the part of patients.  I’d be glad to talk to you about this.

This is clearly a compromise between warring factions in the FDA.  Europe has taken Avandia off the market, which is what the FDA should have done.  For FDA to say they can manage this restriction seems overly optimistic, not evidence-based.  And it will take months for these restrictions to be put in place.  Sometimes a compromise is needed, but this compromise will result in the deaths of patients who could have been saved by other drugs.  I say this as a public health expert, consumer advocate, and on a personal level – my Dad was on Avandia until I asked his doctor to take him off the drug.