Would it matter all that much @ArtirKel, if we made ageing a disease at the FDA?
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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in the mid 2000s, a lot of the grifters in the space decided that strawmanning "FDA doesn't consider aging a disease" was the best way to raise donor dollars. the simple truth is FDA doesn't consider anything that you can't define an endpoint for a disease, until you define it.
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I have a feeling I know who these people are ;)
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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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My read of the work so far puts me in this camp. I found some NIH papers claiming a declaration would direct more pharma money it’s way but I’m skeptical.
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