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Comment by phero_cnstrcts | Hacker News Reader

> The FDA demanded a study of 100 subjects, all of whom had to be “age 18-30, with removable dentures, living alone and far from school zones”. Hillman wasn’t sure there even were 100 young people with dentures, but the FDA wouldn’t budge from requiring this impossible trial. Hillman gave up and switched to other projects

Interesting that the FDA can request such things. Would be a good way to block disruptive products that larger companies wouldn’t like.

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The FDA is often bad: https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-ce....

It is good at "protecting" people from things that might help them. Like many others, I'm being protected from treatments that might harm me, so the cancer I've got can kill me instead.

Any luck with that federal Right To Try angle?

Hello Jake, I just wanted to tell you that I admire your fighting spirit. Best of luck to you and your wife.

It's wild we aren't digging into bacteria phages and instead roll down the antibiotics road while it's ok to use them for sandwich meats. Yes they are living and adapt but so does bacteria.

Somehow I keep loosing confidence in the FDA. That basically sounds like a special interest group giving unreasonable requirements to prevent it succeeding.

What’s the chance that some of the FDA personnel were linked to companies in dental or dental care products? Perhaps some national association of dentists?

It's actually a lot better than it used to be. You wouldn't see a situation where beta blockers were available in Europe a decade ahead of the US nowadays.

I worked for a place that recruited people to test stuff like toothpaste, mouthwash, and other personal care products way back in mid 00s. We worked with a lot of big-name companies, and one of them was trying to get approval for a very similar product. The criteria were very similar to what's described here, where the person had to be perfectly healthy and also wear dentures. I think it took us about a year to recruit like 3 people before they just gave up and dropped the whole thing.

In 2020 the FDA wanted people developing tests for Covid-19 to get some SARS to make sure their test didn't accidentally show a false positive when SARS was present. But of course there was no way the CDC was going to hand out SARS to random research labs.

I'm pretty sure this is just someone at the FDA trying to be diligent in their own way. Mostly this is downstream of powerful companies being able to sue the FDA for allowing things if the FDA doesn't follow procedure, which the FDA wants to avoid.

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