UPDATE: An Esteemed MD Has Called The Biogen Approval We Mentioned This Week “The Worst He’s Seen” — So, He Resigned.

And now a total of three FDA Advisory Panel members have resigned in protest over the approval which ignored the nearly unanimous medical panel’s advice, according to the New York Times.

I may have to write more — again, here over a decade later — on these rather appalling so-called “accelerated” approvals at the Commission level — ones that do not require any actual proof of clinical benefit, just post market studies (to gauge whether there is any).

That is precisely the story of Vytorin®, as well.

Onward — be excellent to one another.

नमस्ते

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