You probably recall that nearly a year ago an FDA advisory committee voted almost unanimously not to license the new drug Aduhelm for Alzheimer’s dementia. Then FDA, with Janet Woodcock at its helm, gave the drug a license anyway.
The data showed the drug was not helpful and probably harmful. Three members of the committee quit loudly and independently, when FDA’s decision became known. Their actions, and the publicity over this decision, are probably what sunk Janet Woodcock’s promotion to Commissioner of FDA; she has been acting Commissioner since the start of the Biden administration, and faces a required termination in that position next month. Otherwise she would probably have been a perfect pick: an MD, a female, and a completely unscrupulous bureaucratic player who was willing to do anything she was instructed to do, even if it gave the agency a tarred reputation.
Now a bit more information has become available, and microscopic bleeding occurred in 19% of those on the drug. It looks like a disaster. Another remdesivir?