6 ms·

Why is the FDA "clearing" something that is completely innocuous like a blood test?

komon 23d ago
I think you need FDA clearance to be able to market a test as actually being effective for treatment/prevention etc. For exactly the same reason woo-woo supplements must disclaim that they aren't intended for that purpose
forestrywat 23d ago
Because tests aren't completely innocuous? Because tests lead people to make significant medical decisions? Look at the supplements world, where grifters are shilling chemicals that cause harm and make radical claims for absurd markups. Or gas station pills. You want those companies making Alzheimer's tests? People going in to a 7-11 and buying a "all illness test card" that tells people they do or don't have degenerative diseases? No, it's very very important to ensure tests are actually indicative and ensure they are well made. To do that, a regulating body needs to be involved.
- willmadden 23d ago
  Their doctor should be qualified to make that judgment without a government bureaucracy evaluating the efficacy of the test on their behalf, unless you want to completely destroy the rate of medical breakthroughs. If there's no potential harm from the procedure itself, the government shouldn't be involved at all. Imagine if every new AI model had to be "cleared" by a government regulator. The role of government in healthcare evaluation needs to be simplified and streamlined. The liability needs to be shifted to doctor, and if it's a case of charlatanism, that liability should include a lengthy prison sentence.
  - forestrywat 23d ago
    There is potential harm. That's the point.
  - lesuorac 23d ago
    So we should just let companies flood doctors with potential treatments and then hope they have enough time to figure out whats relevant for their patients? Seems much better use of time and money to have people developing tests meet a pre-defined standard and after that point they're allowed to flood doctors with marketing for the tests. What use is future medical advancements if it can't meet low bars like proving it works?
    - willmadden 23d ago
      The problem is the FDA's pathetic throughput times. It takes them decades to approve drugs. Blood tests take 1-2 years on average. It's a huge bottleneck. If they could turn these things around faster and work iteratively, it would be different.
      - lesuorac 23d ago
        October[1] to August[2] isn't even a single year. Definitely longer than I'd expect for "cleared" considering everybody involved should have to be licensed and pretty sure you pay a fee to the FDA so that should cover the cost of FDA hiring employees to just call each person involved to verify the submission is accurate. Although IIUC, they were already allowed to do 50yr+ people and the recent clearance is just for 40yr+ so I'm not actually sure how uh impactful this is (a bit more confused why it takes 10 months to drop the age by 10 years). [1]: https://precivityad.com/news/c2n-submits-us-fda-regulatory-filing-for-its-alzheimers-disease-blood-test https://precivityad.com/news/c2n-submits-us-fda-regulatory-f... [2]: https://c2n.com/news-releases/bg2ziqcz39o3wxf5uc04u279ziw0yv https://c2n.com/news-releases/bg2ziqcz39o3wxf5uc04u279ziw0yv
  - BugsJustFindMe 23d ago
    > "If there's no potential harm from the procedure itself" There is potential harm from the procedure itself because of https://en.wikipedia.org/wiki/Opportunity_cost https://en.wikipedia.org/wiki/Opportunity_cost and https://en.wikipedia.org/wiki/Budget_constraint https://en.wikipedia.org/wiki/Budget_constraint and because sticking needles in people and drawing blood carries inherent medical risks.
  - dabinat 23d ago
    Some doctors absolutely would abuse this. I used to date someone whose sister was an endodontist and there was another endodontist in the building who was making over $1m a year. She ended up seeing one of that endodontist’s patients and realized that the other doctor had been making all that money by giving people medical procedures they absolutely did not need. But only another medical professional would know that; the patients were completely oblivious. I said she should blow the whistle but she “didn’t want to rock the boat”. It definitely changed how I feel about doctors. There’s a massive level of trust there, which most doctors will honor but a few will exploit.
    - willmadden 23d ago
      As long as we make examples out of the few that exploit, it will be a-ok.
      - forestrywat 22d ago
        Citation very much needed. Society today is full of people in power who exploit others. Cops, ceos, spouses, etc. Very rarely are they "made an example of", and when they are it doesn't seem to change the intuitions.
  - staticman2 23d ago
    > Their doctor should be qualified to make that judgment without a government bureaucracy This is like saying AI developers should be qualified to evaluate the effacy of a model without testing the model.
  - geraldcombs 23d ago
    You're assuming that everyone has access to a doctor, and that people who do have doctors will visit them instead of just looking at their phone.
deleted 23d ago
[deleted]
tantalor 23d ago
Google "what did theranos do" to find out why.
- willmadden 23d ago
  Google "how was theranos caught" to find out that an investigative journalist uncovered the fraud, and the FDA missed it.
  - xboxnolifes 23d ago
    Ah, so you are aware then.
snarf21 23d ago
It is largely about insurance reimbursement. Your health insurance won't likely cover something the FDA hasn't cleared.
- willmadden 23d ago
  Right, it's paperwork. I get it. Horribly inefficient paperwork.
  - stubish 23d ago
    It would be more efficient for every single insurance company to evaluate every single treatment and decide if they will cover it?

komon 23d ago

I think you need FDA clearance to be able to market a test as actually being effective for treatment/prevention etc. For exactly the same reason woo-woo supplements must disclaim that they aren't intended for that purpose

forestrywat 23d ago

Because tests aren't completely innocuous? Because tests lead people to make significant medical decisions? Look at the supplements world, where grifters are shilling chemicals that cause harm and make radical claims for absurd markups. Or gas station pills. You want those companies making Alzheimer's tests? People going in to a 7-11 and buying a "all illness test card" that tells people they do or don't have degenerative diseases? No, it's very very important to ensure tests are actually indicative and ensure they are well made. To do that, a regulating body needs to be involved.

willmadden 23d ago
Their doctor should be qualified to make that judgment without a government bureaucracy evaluating the efficacy of the test on their behalf, unless you want to completely destroy the rate of medical breakthroughs. If there's no potential harm from the procedure itself, the government shouldn't be involved at all. Imagine if every new AI model had to be "cleared" by a government regulator. The role of government in healthcare evaluation needs to be simplified and streamlined. The liability needs to be shifted to doctor, and if it's a case of charlatanism, that liability should include a lengthy prison sentence.
- forestrywat 23d ago
  There is potential harm. That's the point.
- lesuorac 23d ago
  So we should just let companies flood doctors with potential treatments and then hope they have enough time to figure out whats relevant for their patients? Seems much better use of time and money to have people developing tests meet a pre-defined standard and after that point they're allowed to flood doctors with marketing for the tests. What use is future medical advancements if it can't meet low bars like proving it works?
  - willmadden 23d ago
    The problem is the FDA's pathetic throughput times. It takes them decades to approve drugs. Blood tests take 1-2 years on average. It's a huge bottleneck. If they could turn these things around faster and work iteratively, it would be different.
    - lesuorac 23d ago
      October[1] to August[2] isn't even a single year. Definitely longer than I'd expect for "cleared" considering everybody involved should have to be licensed and pretty sure you pay a fee to the FDA so that should cover the cost of FDA hiring employees to just call each person involved to verify the submission is accurate. Although IIUC, they were already allowed to do 50yr+ people and the recent clearance is just for 40yr+ so I'm not actually sure how uh impactful this is (a bit more confused why it takes 10 months to drop the age by 10 years). [1]: https://precivityad.com/news/c2n-submits-us-fda-regulatory-filing-for-its-alzheimers-disease-blood-test https://precivityad.com/news/c2n-submits-us-fda-regulatory-f... [2]: https://c2n.com/news-releases/bg2ziqcz39o3wxf5uc04u279ziw0yv https://c2n.com/news-releases/bg2ziqcz39o3wxf5uc04u279ziw0yv
- BugsJustFindMe 23d ago
  > "If there's no potential harm from the procedure itself" There is potential harm from the procedure itself because of https://en.wikipedia.org/wiki/Opportunity_cost https://en.wikipedia.org/wiki/Opportunity_cost and https://en.wikipedia.org/wiki/Budget_constraint https://en.wikipedia.org/wiki/Budget_constraint and because sticking needles in people and drawing blood carries inherent medical risks.
- dabinat 23d ago
  Some doctors absolutely would abuse this. I used to date someone whose sister was an endodontist and there was another endodontist in the building who was making over $1m a year. She ended up seeing one of that endodontist’s patients and realized that the other doctor had been making all that money by giving people medical procedures they absolutely did not need. But only another medical professional would know that; the patients were completely oblivious. I said she should blow the whistle but she “didn’t want to rock the boat”. It definitely changed how I feel about doctors. There’s a massive level of trust there, which most doctors will honor but a few will exploit.
  - willmadden 23d ago
    As long as we make examples out of the few that exploit, it will be a-ok.
    - forestrywat 22d ago
      Citation very much needed. Society today is full of people in power who exploit others. Cops, ceos, spouses, etc. Very rarely are they "made an example of", and when they are it doesn't seem to change the intuitions.
- staticman2 23d ago
  > Their doctor should be qualified to make that judgment without a government bureaucracy This is like saying AI developers should be qualified to evaluate the effacy of a model without testing the model.
- geraldcombs 23d ago
  You're assuming that everyone has access to a doctor, and that people who do have doctors will visit them instead of just looking at their phone.

deleted 23d ago

[deleted]

tantalor 23d ago

Google "what did theranos do" to find out why.

willmadden 23d ago
Google "how was theranos caught" to find out that an investigative journalist uncovered the fraud, and the FDA missed it.
- xboxnolifes 23d ago
  Ah, so you are aware then.

snarf21 23d ago

It is largely about insurance reimbursement. Your health insurance won't likely cover something the FDA hasn't cleared.

willmadden 23d ago
Right, it's paperwork. I get it. Horribly inefficient paperwork.
- stubish 23d ago
  It would be more efficient for every single insurance company to evaluate every single treatment and decide if they will cover it?