3 ms·
US approval follows the path of one treatment for one ailment. so if something was useful for 100 ailments, it needs 100 different approvals, and a company wil
by yieldcrv 3y ago
US approval follows the path of one treatment for one ailment.
so if something was useful for 100 ailments, it needs 100 different approvals, and a company willing to attempt doing that
what more likely happens is one treatment is denied for the one ailment the company thought they were tackling, and that one treatment is never pursued again
so there's a lot of waste in this particular approach to protecting the public. I'm not familiar with other approaches.
- boppo1 3y agoSeems like there's a lot of opportunity with those unused treatments, if you can get the right arrangement of capital. If the company gives up on pursuit, perhaps the'd sell it for less than the R&D cost. Someone could go scoop up 'losers' and find a better way to match them to ailments.
- s1artibartfast 3y agoThis happens. Drug companies sell off IP and technology quite often. The bottle neck is you need someone with a better use hypothesis, and a billion dollars to test that. Drug Trials and development are obscenely expensive.
- ackbar03 3y agoWhy doesn't the company pursue it for other purposes? Sounds extremely narrow, as per the comment above. There may be related stuff where it works as a treatment depending on the endpoint?
- s1artibartfast 3y agoBecause it is extremely expensive and complex to pursue each each use. At some point of diminishing returns, it makes sense to let the medical community lead the process of finding and testing uses.
- yieldcrv 3y agobecause there is always lower hanging fruit at that point. Even if this was the most altruistic, non-profit funded goal to solve an obscure ailment, once that inevitably fails - and statistically it is inevitably - all capital has been expended, your team's reputation has been spent. You go to something that has more consensus instead of your alchemy concoction nobody's ever head of and wasn't good for the one thing you made it for.
- s1artibartfast 3y agoOne other facet to consider is that it is already legal to for doctors to the medicine for any of those 100 approvals. those trials serve three purposes, 1) to generate high quality data to support doctor choice, 2) provide defense for medical malpractice suits against doctors, and 3) support insurance reimbursement. Doctors already have discretion to prescribe Tagrisso for the common flu. However, a doctor that does so will struggle to get insurance to cover it, and will have a harder defense if the patient sues.
- instagraham 3y agoOh this is interesting. Basically any "unproven" remedy or treatment can be called upon by any doctor, if they're willing to forego insurance and some legal protection. I was under the impression that patients having to "wait" for approvals would be missing out. But in theory you could get a lot of experimental treatments if you're willing to take the risk?