Malignant is a somewhat atypical book in the cancer space, as Prasad admits in his introduction. It reads a lot more like a combination of investigative journalism and outraged policy wonk (perhaps The Weeds podcast would like him on?) than my preconception of the 'typical' cancer book, which, according to
Would one way to tackle some of this would be to enforce follow up survival trials or other proper confirmatory trials, in a reasonable timeframe and to enforce delisting of a drug if it fails. I was interested to read your take on the reputational capital concerns of the FDA and would be interested in your views on the latest Alzheimer’s approval.
Yeah the FDA is theoretically supposed to do that, but in practice doesn't enforce it very consistently.
Also, companies still make a ton of $ in the meantime, at least in the US. Other countries healthcare systems are less willing to pay full $ for those drugs.
I'm working on Aduhelm post but overall, very bad decision. Surrogate with a history of not working, likely no benefit, if there is one it's marginal, inconsistent with prev Amyloid drugs, etc.
I will let you review the cost/ benefit, QALY etc on Adu but I think seeing the FDA through the Carpenter lens of reputation has enhanced my understanding on these decisions. The second order impact that no one has really reviewed (and maybe it is too hard) - has that it has/will accelerate development of phase 1/2 drugs as bio pharma reads this as a positive signal and lowers perceived regulatory risk. Stock prices reacted. There may be a similar effect in cancer. While I don’t dispute some cancer drugs are very marginal at the median (but not in some tails) it has accelerated research into this area and esp. as some lower hanging fruit has been harvested it seems likely to need much more £ and research to make further gains. That said some of the these drugs are marginal and doctors themselves don’t take them.
There's a risk research $ gets misdirected into the amyloid dead end. That would be a tragedy, esp bc the field was beginning to move away from it more towards Tau, mitochondria, neuroinflammation more broadly, etc.
So there's some downstream 2nd order effects that could be /worse/ than the short term fiscal waste.
I think it is true that more £ will be spent on aBeta ideas, my impression is that scientists are still debating the area though AB was falling out of favour, and if it truly turns out to be a dead end then it will be somewhat wasted. Somewhat - because at least the pathway would be fully explored and because I think investment in all areas are accelerated by this. That said there would probably be other less costly ways to accelerate development. And also less costly potential therapies (eg who is going to do a deep trial on intermittent fasting or intensity exercise Alzh prevention ? I don’t see work being done there ). Anyway so I agree money will/could be wasted in aBeta but I think the field will benefit from more £ generally. As an aside, do you have a view on the current patent system ?
Would one way to tackle some of this would be to enforce follow up survival trials or other proper confirmatory trials, in a reasonable timeframe and to enforce delisting of a drug if it fails. I was interested to read your take on the reputational capital concerns of the FDA and would be interested in your views on the latest Alzheimer’s approval.
Yeah the FDA is theoretically supposed to do that, but in practice doesn't enforce it very consistently.
Also, companies still make a ton of $ in the meantime, at least in the US. Other countries healthcare systems are less willing to pay full $ for those drugs.
I'm working on Aduhelm post but overall, very bad decision. Surrogate with a history of not working, likely no benefit, if there is one it's marginal, inconsistent with prev Amyloid drugs, etc.
I will let you review the cost/ benefit, QALY etc on Adu but I think seeing the FDA through the Carpenter lens of reputation has enhanced my understanding on these decisions. The second order impact that no one has really reviewed (and maybe it is too hard) - has that it has/will accelerate development of phase 1/2 drugs as bio pharma reads this as a positive signal and lowers perceived regulatory risk. Stock prices reacted. There may be a similar effect in cancer. While I don’t dispute some cancer drugs are very marginal at the median (but not in some tails) it has accelerated research into this area and esp. as some lower hanging fruit has been harvested it seems likely to need much more £ and research to make further gains. That said some of the these drugs are marginal and doctors themselves don’t take them.
There's a risk research $ gets misdirected into the amyloid dead end. That would be a tragedy, esp bc the field was beginning to move away from it more towards Tau, mitochondria, neuroinflammation more broadly, etc.
So there's some downstream 2nd order effects that could be /worse/ than the short term fiscal waste.
I think it is true that more £ will be spent on aBeta ideas, my impression is that scientists are still debating the area though AB was falling out of favour, and if it truly turns out to be a dead end then it will be somewhat wasted. Somewhat - because at least the pathway would be fully explored and because I think investment in all areas are accelerated by this. That said there would probably be other less costly ways to accelerate development. And also less costly potential therapies (eg who is going to do a deep trial on intermittent fasting or intensity exercise Alzh prevention ? I don’t see work being done there ). Anyway so I agree money will/could be wasted in aBeta but I think the field will benefit from more £ generally. As an aside, do you have a view on the current patent system ?
No strong views on patents