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Member of FDA’s expert panel resigns over Alzheimer’s therapy approval:
Following the Food and Drug Administration's polarizing authorization of the Alzheimer's therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug's approval has resigned.
Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA's expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday "due to this ruling by the FDA without further discussion with our advisory committee."
The advisory committee, which convened in November, couldn't have been more openly skeptical of the drug, also known as aducanumab. Ten of the 11 panelists found that there was not enough evidence to show it could slow cognitive decline. The 11th voted "uncertain."
(Score: 0) by Anonymous Coward on Friday June 11 2021, @04:26PM
I'm not an expert, but to confirm my understanding (and maybe make it more illustrative), maybe this would be an appropriate analogy?
Somebody finds diamonds in ThirdWorldIstan (the AB malfunctions). Then lots of prospectors go flooding in and commence stripmining, leading to lots of pollution (AB piles up in big heaps). The pollution kills the herbivores in the local ecology (AB damages T), which devastates the food chain (T damages M). So we have a wrecked ecology (dementia).
This drug would remove all the stripminers (remove the piles of AB), but doesn't actually fix the fundamental problem of the herbivores and the food chain being dead (T and M are still damaged), hence the ecology is still ruined (dementia still exists).
Is that roughly what you were saying?