July 8, 2021 | The New York Times
In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug
From the New York Times:
Under fire for approving a questionable drug for all Alzheimer’s patients, the Food and Drug Administration on Thursday greatly narrowed its previous recommendation and is now suggesting that only those with mild memory or thinking problems should receive it.
The reversal, highly unusual for a drug that has been available for only a few weeks, is likely to reduce the approximate number of Americans who are eligible for the treatment to 1.5 million from six million.
“The revision of this label is yet another piece of evidence that should cause the American public to be concerned about how F.D.A. is practicing its regulatory science,” said Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center (and professor of Medical Ethics & Health Policy).