Biogen Inc (BIIB)

[tradeherpete]

The fallout has already been widespread. So far, three members of the FDA’s advisory committee have resigned, one of them calling the process a “sham.” Doctors who helped run Biogen’s clinical studies are speaking out, and others are penning editorials that they won’t be prescribing Aduhelm until they see evidence of effectiveness. But no one should hold their breath. When the FDA greenlit Aduhelm for use, it told Biogen it had nine years to run the confirmatory studies necessary to prove Aduhelm’s effectiveness. Nine years of people taking this drug that existing data suggests might not do anything meaningful. With Aduhelm poised to become among the biggest blockbuster drug in history—analysts estimate annual revenues could peak at $10 billion—Biogen probably isn’t in a hurry. But they might not even have to collect that extra data at all (for its part, Biogen said in an email to Slate, “We are working diligently to initiate the confirmatory trial”). Ross, the Yale FDA regulatory expert, looked at FDA approvals from 2005–12, and found that post-market confirmatory studies—ones that truly verified the clinical value of a surrogate outcome—only took place about 10 percent of the time. Despite this dismal compliance rate, according to Ross, the FDA has never fined a company for failing to do a confirmatory study and rarely uses its power to withdraw a drug later shown to be clinically ineffective. In an email to Slate, the FDA did not offer comment on whether it would use its power to withdraw Aduhelm should the drug ultimately prove clinically ineffective but “will carefully monitor trial progress and support efforts to complete this trial in the shortest possible timeline.”

https://slate.com/technology/2021/06/alzheimers-drug-aduhelm-fda-outcomes-plaques.amp