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> 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 s

> 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.

elcritch 3y ago
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?
- local_crmdgeon 3y ago
  [flagged]
  - Grimblewald 3y ago
    I trust the sceince just fine, i dont trust corporate interests and how heavily and deeply coporate rot has penetrated into our institutions. I activly expect dishonesty on the part of corporate interest, and corporate interest is increasingly if not already entierly, government interest.
    - jussij 3y ago
      Do you have any examples of how the FDA is starting to put corporate interest ahead of public interest?
      - elcritch 3y ago
        I’d say corporate and good-old-boy senior researcher clubs: https://www.nbcnews.com/news/amp/rcna63662 https://www.nbcnews.com/news/amp/rcna63662
        jussij 3y ago
        It's very difficult for any major institution to not have problems similar to this, as there will always be individuals in positions of power who take it upon themselves to make decisions that can be construed as corrupt. However, the fact this issue was revealed to the public, reported widely and also found to be a highly dubious shows the institute is working fine. They appear to have systems and processes in place to help stop these kinds of dubious decisions, and because of the blowback from this rather poor decision, I'm certain the people at the FDA working the next round of approvals will make sure they hold up to scrutiny, which will be stronger than ever.
        elcritch 3y ago
        Of course major institutions will always face these sorta problems. However your comment seems to assume the FDA self-corrected. They faced a lot of external criticism and eventually partially capitulated. Even then they just restricted its listed audience. > They appear to have systems and processes in place to help stop these kinds of dubious decisions Except that it was external pressure that forced changes, not internal processes. The congressional report found that the FDA violated their own processes. Thankfully we still have a fairly transparent government and the incident was made public. Though congress seems to have just given them a slap in the wrist. No officials were fired AFAICT, why wouldn't other FDA officials do the same in the future? Based on the parent article it might still be happening.
      - financltravsty 3y ago
        FDA Warning Letters: your pharmaceutical manufacturing plant was found to have adulteration and QA issues (again). Your medication actually has other medications or precursor/intermediate chemicals in it (again). FDA's response: a wag of the finger (again). So you "fix" the issue the next time the FDA Boy Scout comes around. All set. Rinse and repeat.
    - elcritch 3y ago
      Same here. I also think it’s “we the people’s” fault to a large degree as well. These institutions require citizens to elect leaders who will put them in check. We don’t do that. The system largely works so people don’t really care that much, myself included.
      - autoexec 3y ago
        Considering all the literal poison and bacteria infested shit in our food I'm not even convinced it mostly works. The FDA simply isn't doing their job.
    - readthenotes1 3y ago
      And yet, modern science involves humans, human interests, and human failings. Science practice is as flawed as the people that do it.
      - Grimblewald 3y ago
        Yes, but the pay is shit, the social recognition is non existent, etc. So its not going to attract as many of the dark triad types like law or upper managment would.
        readthenotes1 3y ago
        I'd ask for proof of that assertion but...
        elcritch 3y ago
        Hmmm that’s an important factor. It’s one reason I still “trust in scientific process”. While it’s corruptible, imperfect, etc enough scientists still believe in the ideals of science. Otherwise why do it at all? Still at a top institution like the FDA will attract the grafters and dark triad types in the field. Some of the most conceited self-centered types I’ve ever met are top researchers / academics and I’ve met a handful of VC CEOs. Look at the disdain for the “average joe” that leaks out of the emails between Dr Fauci and Dr Collins when they wanted to squash scientific debate on Covid (1). 1: https://www.wsj.com/articles/fauci-collins-emails-great-barrington-declaration-covid-pandemic-lockdown-11640129116 https://www.wsj.com/articles/fauci-collins-emails-great-barr...
  - taylorius 3y ago
    Yes, but Not the People.
- Symmetry 3y ago
  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.
jseliger 3y ago
The FDA is often bad: https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/ 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.
- hypercube33 3y ago
  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.
- autoexec 3y ago
  Any luck with that federal Right To Try angle?
- inglor_cz 3y ago
  Hello Jake, I just wanted to tell you that I admire your fighting spirit. Best of luck to you and your wife.
erellsworth 3y ago
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.
Symmetry 3y ago
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.

elcritch 3y ago

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?

local_crmdgeon 3y ago
[flagged]
- Grimblewald 3y ago
  I trust the sceince just fine, i dont trust corporate interests and how heavily and deeply coporate rot has penetrated into our institutions. I activly expect dishonesty on the part of corporate interest, and corporate interest is increasingly if not already entierly, government interest.
  - jussij 3y ago
    Do you have any examples of how the FDA is starting to put corporate interest ahead of public interest?
    - elcritch 3y ago
      I’d say corporate and good-old-boy senior researcher clubs: https://www.nbcnews.com/news/amp/rcna63662 https://www.nbcnews.com/news/amp/rcna63662
      - jussij 3y ago
        It's very difficult for any major institution to not have problems similar to this, as there will always be individuals in positions of power who take it upon themselves to make decisions that can be construed as corrupt. However, the fact this issue was revealed to the public, reported widely and also found to be a highly dubious shows the institute is working fine. They appear to have systems and processes in place to help stop these kinds of dubious decisions, and because of the blowback from this rather poor decision, I'm certain the people at the FDA working the next round of approvals will make sure they hold up to scrutiny, which will be stronger than ever.
        elcritch 3y ago
        Of course major institutions will always face these sorta problems. However your comment seems to assume the FDA self-corrected. They faced a lot of external criticism and eventually partially capitulated. Even then they just restricted its listed audience. > They appear to have systems and processes in place to help stop these kinds of dubious decisions Except that it was external pressure that forced changes, not internal processes. The congressional report found that the FDA violated their own processes. Thankfully we still have a fairly transparent government and the incident was made public. Though congress seems to have just given them a slap in the wrist. No officials were fired AFAICT, why wouldn't other FDA officials do the same in the future? Based on the parent article it might still be happening.
    - financltravsty 3y ago
      FDA Warning Letters: your pharmaceutical manufacturing plant was found to have adulteration and QA issues (again). Your medication actually has other medications or precursor/intermediate chemicals in it (again). FDA's response: a wag of the finger (again). So you "fix" the issue the next time the FDA Boy Scout comes around. All set. Rinse and repeat.
  - elcritch 3y ago
    Same here. I also think it’s “we the people’s” fault to a large degree as well. These institutions require citizens to elect leaders who will put them in check. We don’t do that. The system largely works so people don’t really care that much, myself included.
    - autoexec 3y ago
      Considering all the literal poison and bacteria infested shit in our food I'm not even convinced it mostly works. The FDA simply isn't doing their job.
  - readthenotes1 3y ago
    And yet, modern science involves humans, human interests, and human failings. Science practice is as flawed as the people that do it.
    - Grimblewald 3y ago
      Yes, but the pay is shit, the social recognition is non existent, etc. So its not going to attract as many of the dark triad types like law or upper managment would.
      - readthenotes1 3y ago
        I'd ask for proof of that assertion but...
      - elcritch 3y ago
        Hmmm that’s an important factor. It’s one reason I still “trust in scientific process”. While it’s corruptible, imperfect, etc enough scientists still believe in the ideals of science. Otherwise why do it at all? Still at a top institution like the FDA will attract the grafters and dark triad types in the field. Some of the most conceited self-centered types I’ve ever met are top researchers / academics and I’ve met a handful of VC CEOs. Look at the disdain for the “average joe” that leaks out of the emails between Dr Fauci and Dr Collins when they wanted to squash scientific debate on Covid (1). 1: https://www.wsj.com/articles/fauci-collins-emails-great-barrington-declaration-covid-pandemic-lockdown-11640129116 https://www.wsj.com/articles/fauci-collins-emails-great-barr...
- taylorius 3y ago
  Yes, but Not the People.
Symmetry 3y ago
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.

jseliger 3y ago

The FDA is often bad: https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/ 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.

hypercube33 3y ago
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.
autoexec 3y ago
Any luck with that federal Right To Try angle?
inglor_cz 3y ago
Hello Jake, I just wanted to tell you that I admire your fighting spirit. Best of luck to you and your wife.

erellsworth 3y ago

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.

Symmetry 3y ago

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.