Could Desperate Parents’ Pleas Sway The FDA To Approve A Drug Even If Evidence It Works Is Lacking?

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Publish Date:
April 24, 2016
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Forbes
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Summary

You don’t usually hear people compare Food and Drug Administration advisory committee meetings to a world-class sporting event, but this is how Brian Denger described the one set for Monday:

“For the Duchenne community, this is going to be more like the Super Bowl,” Denger, a supermarket manager from Biddeford, Maine, told me.

“FDA should be influenced little, if at all, by patient wishes but a lot by the risks of the disease–and it is,” Henry Greely, director of Stanford Law School’s Center for Law and the Biosciences, told me. For example, he said, “pancreatic cancer drugs can be much less safe and effective than acne medication.”

“I’m sure FDA is taking the fact that DMD is untreatable and awful into account,” Greely said. “But it still must, by law, and should (emphasis Greely’s), by ethics and policy, approve only drugs that are proven sufficiently safe and effective.”

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