COVID Vaccine, Anduhelm, and the FDA Approval process

This is from TDAmeritrade discussing Anduhelm (an Alzheimer’s medication) and the FDA approval process.

" Yesterday’s U.S. Food and Drug Administration (FDA) approval of Biogen’s (BIIB) Aducanumab (brand name Aduhelm) wasn’t just the first time the FDA has approved a new drug for Alzheimer’s disease since 2003. It also might imply some ripples for the entire U.S. pharmaceutical industry.

Two of the FDA’s key thresholds for drug approval are safety and efficacy. Meaning data from clinical trials must show not just that a drug is safe to use, but also that it really works. That’s a stricter standard than the European Medicines Agency (EMA), which gives the green light “if the benefits of the medicine are greater than its risks,” as the EMA says on its internet site. Going into the Aduhelm decision, there was mixed data on the drug’s efficacy, with two studies in direct conflict. An FDA panel of outside experts actually advised the FDA to reject the drug based on questions over efficacy.

In its approval, the FDA said Aduhelm “consistently and very convincingly reduced the level of amyloid plaques in the brain” in both studies. A reduction in those plaques is “reasonably likely to predict important benefits to patients,” the agency added. Let’s play that tape again: “Reasonably likely to predict” isn’t the same as “effective,” so maybe the FDA is taking a slightly different approach here—with the caveat that the FDA will require BIIB to conduct post-approval studies to show clinical benefit and could pull approval if those fail. The other change from normal protocol was the FDA overruling its advisory committee, which is rare. All this could get people thinking about what it means for future drug approvals."

With this approval, and government-sanctioned rapid deployment the Covid Vaccine*, are we entering a new era of Big Pharma irresponsibility?

*I get WHY the for the Covid deployment, just wondering the precedent it may help enable…