The best steelman I’ve heard for the approval is that the FDA just created a multi-billion dollar market for Alzheimer drugs. Once people are paying 50k/year for this drug, other companies will have enormous incentives to try to get a piece of the market, which will create better treatments over the long run. So yes, right now there’s gonna be a lot of money wasted on an ineffective treatment, but here the FDA might actually be incentivizing more innovation.
This decision made it harder to bring new Alzheimer drugs to market as one of the people who resigned from the FDA’s advisory panel explains on CNN.
Companies already knew beforehand that Alzheimer drugs are a multi-billion dollar market.
The fact that the FDA approved the drug based on reducing amyloid beta plaques, suggest that other companies are incentivied to develop drugs that target amyloid beta plaques as well instead of going for something that’s actually promising.
Previous discussion of why targeting amyloid beta plaques likely isn’t a good idea can be found at the recent LessWrong post Core Pathways of Aging.
Companies already knew beforehand that Alzheimer drugs are a multi-billion dollar market.
But they didn’t know how willing the FDA was to approve placebo-like drugs.
Cassava Sciences, whose Alzheimer drug candidate doesn’t target beta amyloid, rose in response to that approval. I doubt that many people will be satisfied enough with this drug to deter signups for new trials.
I don’t know what the net effect will be on the development of good drugs, and I doubt that anyone else does either.
The drug isn’t just an inert sugar pill. Placebo’s don’t cause bleeding in more then 10% of the patients. Additionally it does change a metric in the right direction. It’s just not a metric that’s clinically beneficial.
That suggests that other drugs that also target metrics that aren’t clinically benefitial might get approved.
I doubt that many people will be satisfied enough with this drug to deter signups for new trials.
It results in trials being more work because they now have to make an argument about how their treatment relates to the “state of the art”. That might mean having a control group that takes expensive aducanumab.
The best steelman I’ve heard for the approval is that the FDA just created a multi-billion dollar market for Alzheimer drugs. Once people are paying 50k/year for this drug, other companies will have enormous incentives to try to get a piece of the market, which will create better treatments over the long run. So yes, right now there’s gonna be a lot of money wasted on an ineffective treatment, but here the FDA might actually be incentivizing more innovation.
This decision made it harder to bring new Alzheimer drugs to market as one of the people who resigned from the FDA’s advisory panel explains on CNN.
Companies already knew beforehand that Alzheimer drugs are a multi-billion dollar market.
The fact that the FDA approved the drug based on reducing amyloid beta plaques, suggest that other companies are incentivied to develop drugs that target amyloid beta plaques as well instead of going for something that’s actually promising.
Previous discussion of why targeting amyloid beta plaques likely isn’t a good idea can be found at the recent LessWrong post Core Pathways of Aging.
But they didn’t know how willing the FDA was to approve placebo-like drugs.
Cassava Sciences, whose Alzheimer drug candidate doesn’t target beta amyloid, rose in response to that approval. I doubt that many people will be satisfied enough with this drug to deter signups for new trials.
I don’t know what the net effect will be on the development of good drugs, and I doubt that anyone else does either.
The drug isn’t just an inert sugar pill. Placebo’s don’t cause bleeding in more then 10% of the patients. Additionally it does change a metric in the right direction. It’s just not a metric that’s clinically beneficial.
That suggests that other drugs that also target metrics that aren’t clinically benefitial might get approved.
It results in trials being more work because they now have to make an argument about how their treatment relates to the “state of the art”. That might mean having a control group that takes expensive aducanumab.
Crappy drugs that only slow the decline a bit might need an aducanumab comparison, but why would a drug that reverses the decline need that?
See Cassava’s trial results.
See also this clinical trial of Bredesen’s approach (press release here).