Would it matter all that much @ArtirKel, if we made ageing a disease at the FDA?
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Replying to @WillRinehart @ArtirKel
short answer, no. long answer, FDA is open to aging as a disease, you just need to define how you are measuring it. Barzilai got the agency to accept his measure in TAME. There's a dozen other approaches, some more modern. If you want to run a trial, the agency won't stop you.
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Replying to @WillManidis @WillRinehart
Indeed, there are a bunch of clinical trials with 'aging' as the disease they target, like https://clinicaltrials.gov/ct2/show/NCT04488601 … . It's all about the measurement problem, and defining aging is hard (https://nintil.com/what-is-aging/ )
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The FDA cares about health ultimately, so one has to say that the drug is curing in a tangible way various things. 'aging' is too abstract a process. One can have multiple composite endpoints (like TAME), the FDA has long allowed that
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Maybe what would rather need to change the way some of these therapies are accessed. Let's say TAME succeeds. What happens next, will MDs prescribe metformin for longevity to everyone? They don't have to. Will insurers reimburse it? And so forth
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ive been harping on this for years-- but this all is downstream of running a single damn trial. the agency will bend their will to you if you can design, enroll, and complete a trial. No one in this space has meaningfully gotten past design, one wonders why.
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