Why the FDA approved a controversial Alzheimer’s drug

Pam Belluck, The New York Times:

Well, what they said was, they actually acknowledged that there was not clear evidence of clinical benefit, that there was some kind of murkiness in the evidence about whether this will actually help patients slow down their memory and thinking problems.

But what they said is, there is some suggestion of that. And one thing that everybody on all sides agree that the drug does do is that it attacks a key protein in Alzheimer’s disease. This is a protein called amyloid. And it is the protein that clumps into plaque in the brains of people who have Alzheimer’s.

So, they said, well, we are going to approve this drug because it does can attack the biology of the disease. We have some signal that there might be some benefit for patient symptoms, and we are going to tell the company that they need to do another clinical trial. And if the results of that trial do not show benefit, then the FDA might revoke the approval, and it could end up being that those trials don’t show benefit at all.

The issue with that is that the clinical trial takes three or four, five years. And so this drug will be on the market, patients will be using it without actually being certain that it has the ability to help them.

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