I don’t think you’re taking this on as your own but I’ve lost all empathy for that position. We have other mechanisms to remedy fraudulent or substantively anti-social behavior.
I was actually in the same boat as the previous commenter but my daughter has Type 1 diabetes so hardware scarcity wasn’t the limiting factor. Actually nothing was. I was able to monitor my blood glucose level continuously for a month and it answered my questions. I’ll likely do it again in a few months.
Well maybe for a lemon car, but literally the FDA was started because people would take medications and medical advice from scammers and die. Like I said, they can be overzealous and I’m not arguing that certain things should be allowed (like glucose monitors, probably), but you also have to realize that for every one of you who understand what the monitor does, there’s probably 50 people who would drink bleach solution to cure cancer and 50 more who would sell those 50 the bleach solution.
Type 1: FDA approves something that ends up killing people. Many die. Type 2: FDA doesn't approve something that would cure disease. Many die.
The FDA, and public discourse is only about Type 1, and it is the one FDA is very focused on minimizing. As a result, many Americans - probably millions over the decades - die from Type 2 errors.
> you also have to realize that for every one of you who understand what the monitor does, there’s probably 50 people who would drink bleach solution to cure cancer
If you honestly think 98% of Americans would drink bleach for their health, I understand why you favor a strict approach.
The numbers weren't quite that high, though
[0] https://www.dallasobserver.com/news/dallas-qanon-cult-member...
It’s possible to get ~50,000 lives lost over the last 80 years assuming your overly pessimistic when running the numbers, but that generally assumes people can speed things up without any negative consequences from less stringent procedures. In practice the FDA is likely moving to fast rather than to slow and would save significantly more lives long term by requiring more data.
Basically if someone gets a terminal illness and doesn’t seek medical attention, then the disease is blamed for their death.
If that same person does seek medical attention and dies anyway, it’s still the disease that killed them as long as the doc followed the FDAs runbook.
BUT if the doc tried anything new and the patient dies, well then obviously the doc killed them and they should lose their license and die bankrupt.
Clearly just letting docs go cowboy isn’t likely to have great outcomes either, but something in the middle may.
The rules are very loose for studies on terminal people, but allowing random treatments without being part of a study has minimal utility. Something might prolong someone’s life but you have no way to verify and cancer treatment very often kills people before the cancer.
Of course, that's the point I'm trying to make. Doctors have very limited opportunity to replace the runbook with a specific treatment plan because, at least based on my limited observation, they are not allowed to create specific treatment plans without the runbook.
>The rules are very loose for studies on terminal people,
The patient I was working with was terminal and the only rule that was loose seemed to be the ability to abandon a treatment plan early when it stopped showing promise.
>but allowing random treatments without being part of a study has minimal utility. Something might prolong someone’s life but you have no way to verify and cancer treatment very often kills people before the cancer.
Minimal utility to medicine maybe, but not to the individual. If a person invests hundreds or thousands of hours investigating adjuvant therapies, reviewing trial outcomes and talking to PI, researchers, clinicians and trial coordinators, I'm of the opinion their primary oncologist should at least entertain a suggestion, not just dismiss the conversation with 'that's not standard of care'.
Anyway, I'm not going to change anything here on HN. Thanks for your time.
That killed 10,000 Americans a year, 170,000 total.
That's just one drug, that finally got approved.
Atenolol is actually vastly less effective than other beta blockers and it’s continued use has cost many lives. The FDA not approving it would have been a net benefit.
2. Something I've seen other T1s talk about - the scarcity of hardware, specifically given the current silicon shortage. While I'm not sure how much this directly affects, I do know that the Freestyle Libre sensor got significantly more expensive between 2019 till 2021 (from about $25ish to $60). But take this with caution as I moved countries and haven't continuously being using it.
https://www.fda.gov/drugs/postmarket-drug-safety-information...
2) You can treat high blood sugar with diet. You have to know you have high blood sugar though.
3) More demand generally means lower prices in the long run unless some specific component is constrained, which I doubt is the case for these sensors.
Insulin, sure. But why do you think Metformin is dangerous?
1. Exist as a significant force?
2. Are being stopped by these restrictions?
3. Would do more harm than the FDA promoting ignorance of blood glucose levels?
Because from a comfortable position in an armchair, that perspective seems to be extremely pessimistic about people's ability to make basic life choices. Pessimistic to the point where I don't see how society could function if it is in line with reality.
https://en.wikipedia.org/wiki/Food_and_Drug_Administration#H...
I took you up on it regardless, and it doesn't have much to do with snake oil salesmen according to the Wikipedia article.
Either way, nobody is arguing for the abolition of the FDA. The paternalistic attitude and restrictions are what the parent commenters have an issue with.
> By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.
> President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act into law on June 24, 1938.
But again, the issue is not deciding what's safe and what's effective. It's finding that something is effective and then telling citizens they can't use effective treatments (or even tests) arbitrarily.
I'm glad the FDA is testing the safety and effectiveness of tests and cures. That doesn't mean the grandparent commenter who wants to monitor their blood glucose levels should be dismissed.
I'm sure that someone could injure themselves really badly with a glucose monitor, but the risk profile probably isn't that different from the wide range of garden implements we let people run around with (like ladders or hedge clippers).
2. Not stopped from selling stuff which efficacy is not proven. Still stopped from selling stuff which is known dangerous.
3. FDA is just enforcing a CYA policy here. It shifts all decisions to doctors who can decide to prescribe a device or a drug, and are personally accountable for malpractice. No administration wants to lose political points and votes because it allowed something obscure, that something led to an accident, and the accident was turned into a national-level scandal by rage-hungry media.
Pregnancy/HIV/diabetes tests however should be rather easy to define baseline requirements/tolerances for.
And drugs are somewhere in between.
Audiophiles salesmen want to believe just as much as the customers.
Disclaimer: Built speakers and amplifiers in a previous life and never understood how people would fret so much about cables.
Consequences of any output from audiophile gear are normally not that serious. For a pregnancy test, it could be literally life and death: say, a murder from jealosy, or a suicide from guilt. This makes a strong case for regulation of what can have words "pregnancy test" and synonyms.
I'm fine with people being able to buy stuff that can kill them, be it a gun, a rope, or a substance. But I stand for clear and enforced labeling of such things, regulated proper packaging that prevents accidents, and other such measures that make sure the consumer has plenty of warning, and acts by deliberate choice.
With substances, it's much harder to assess if the thing in hand can kill you, than with a shotgun or a scythe.
Dietary supplements, homeopathic "medicine", chiropractic, essential oils, Goop and similar new age stuff ... Snake oil business is thriving and expanding if anything.
Why not oversee/regulate the market and allow good products while disallowing snake oil?
What are you even saying? We should restrict selling fish to only those who actually need omega-3 and vitamin-D? Or that we've been fishing too much for the past 50 years that the seas are dry? Or that we should restrict selling fish to those who really need it (how do you define that and who is you)?
Apologies for the fish analogy but you managed to sidetrack me from the beginning.
If there's short supply of home tests the US, the government as far as I'm aware is able to authorize production solely for a specific cause. No FDA intervention needed. But if there's no urgent need then a company can manufacture a product, and FDA can within reasonable (this is what is being argued) parameters decide who gets to sell what and to whom.
The issue outlined in the OP is that the FDA seems to be hellbent on having a monopoly on testing, whatever the testing is about. Are you able to refute that? Is there a shortage of testing going on right now?