Just looking from the outside the Aduhelm approval just seems kinda insane. Approving a drug that failed its primary trials based on a biomarker that is under serious doubt just doesn't make any sense. And it's not like this is a harmless drug, it does have quite serious potential side effects.

This drug was largely responsible for the giant increase in Medicare Part B premiums for 2022, which is now being considered for a partial rollback.

https://www.cnbc.com/2022/01/10/government-may-scale-back-me...

Free-market folks could argue: what's the point of the FDA here? The organizations that bear the cost of the medicine have decided that there isn't enough evidence of benefit from Aduhelm and further clinical evidence is required.

Perhaps the FDA's involvement should stop at Phase 2? Allow the free market to decide whether the clinical trial and efficacy results are sufficiently positive. The current setup encourages Pharma companies to design trials for the purpose of gaming the FDA.

“this is safe and doesn’t work” is batshit insane; aduhelm never should have been approved, but at least a fail-safe worked and it’ll never be widely used.

Remember the stories by reporters saying this drug would bankrupt the US because it would cost $500B per year?

This outcome was entirely predictable based on Medicare’s NCD process.

A sad thing is the FDA dragged its feet on approving the covid vaccine for all age groups, taking 14 months. And vaccine makers/CDC had hard data vaccination would cut the 10,000 weekly death toll by 85%.

Here they approve a costly drug with almost no track record. FOLLOW THE MONEY!