6 ms·

On the other hand, it does prevent snake oil sales from screwing over people who aren’t as savvy as you might be. I worked in medical devices and for the most p

by ok_dad 5y ago

On the other hand, it does prevent snake oil sales from screwing over people who aren’t as savvy as you might be. I worked in medical devices and for the most part the regulations are good, if a bit overzealous at times. Personally, I think several changes could be made to make medical devices both safe and effective, and also available to those who want to tinker and test out things on their own.

jcims 5y ago
> On the other hand, it does prevent snake oil sales from screwing over people who aren’t as savvy as you might be. 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.
- ok_dad 5y ago
  > We have other mechanisms to remedy fraudulent or substantively anti-social behavior. 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.
  - BurningFrog 5y ago
    There are two types of errors the FDA can do. Both will cause deaths. 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.
    - netizen-936824 5y ago
      Oddly enough we do have current day examples of people drinking bleach after being told it would help with COVID. The numbers weren't quite that high, though
      - cperciva 5y ago
        Perhaps some cases, but the increase in bleach related poisonings was associated with accidental consumption by young children after parents started sanitizing surfaces more early in the pandemic.
        shakna 5y ago
        And adult Americans [0] lost to conspiracies and the insanity we've seen popping up around the last couple years. [0] https://www.dallasobserver.com/news/dallas-qanon-cult-members-are-drinking-toxic-chemicals-en-masse-13038506 https://www.dallasobserver.com/news/dallas-qanon-cult-member...
      - BurningFrog 5y ago
        Do we really have documented cases?
    - Retric 5y ago
      You’re vastly overestimating the rate of progress and these delays to come up with millions of deaths. The delay isn’t decades for any one medical treatment and the delay also regularly saves lives. 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.
      - jcims 5y ago
        I’d wager that the numbers in cancer treatment alone are much higher than that. From my personal experience as an advocate for a patient, most doctors seem to be scared to death to get off the ‘standard of care’ rails and *definitely* aren’t comfortable suggesting an alternate treatment plan once the primary doctor has started one. 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.
  - jcims 5y ago
    I understand the position, I guess I’m just not as sympathetic to it as I used to be. It used to be ’think of the children’, now it’s becoming ’think of the morons’.
  - Dylan16807 5y ago
    But the bleach thing is happening anyway, despite lack of approval. And bleach certainly isn't on the list of what would get through if approval was loosened some.
roenxi 5y ago
Is there evidence that these snake oil people: 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.
- ok_dad 5y ago
  Read the history of the FDA, my friend. They’re here for a reason. I’m not going to educate you on something you can Google (but probably won’t).
  - ahmedalsudani 5y ago
    There's no reason to be this snarky. https://en.wikipedia.org/wiki/Food_and_Drug_Administration#History 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.
    - ok_dad 5y ago
      Did you read it? Literally the FDA was created in response to snake oil remedies killing and injuring people. > 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.
user_7832 5y ago
I'd like to add on to your comment with 2 more points as a Type-1 diabetic: 1. People might be tempted to treat high sugars with insulin/metformin - both of which should be only used on a doctor's prescription, and insulin can outright be (very easily) fatal if you don't know what you're doing. 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.
- nradov 5y ago
  High blood sugar is now also commonly treated with prescription SGLT2 inhibitors. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/sodium-glucose-cotransporter-2-sglt2-inhibitors https://www.fda.gov/drugs/postmarket-drug-safety-information...
- BobbyJo 5y ago
  1) People chase therapies like Metformin without seeing their blood sugar. 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.
- loeg 5y ago
  > People might be tempted to treat high sugars with insulin/metformin - both of which should be only used on a doctor's prescription, and insulin can outright be (very easily) fatal if you don't know what you're doing. Insulin, sure. But why do you think Metformin is dangerous?
spurgu 5y ago
So what's the argument against selling perfectly functioning equipment to people? Why not oversee/regulate the market and allow good products while disallowing snake oil?
- ok_dad 5y ago
  For one, manufacturing is limited for these products and selling them to people who don’t need it, especially right now, prevents actual diabetics from getting the life saving devices they need.
  - spurgu 5y ago
    Wait, weren't we discussing 70's, 80's and 2017 devices as mentioned in the OP? 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?
    - ok_dad 5y ago
      The more I read comments here the more it cements my opinions that people need the FDA even with its foibles; you’re not even reading what I’m actually saying, please stop arguing in bad faith and twisting my words. I’m done here.
      - spurgu 5y ago
        You seem to be missing my points as well. I also said the FDA is needed, but just that regulating "snake oil" is a slippery slope and not really viable in a lot of cases. Like if you try to regulate audiophiles you're going to end up in a downwards spiral of bureaucracy that will never end and will only cause damage and distract from things that would be actually worthwhile regulating.
eru 5y ago
Alas, there seems to be plenty of snake oil in medicine left. How do we know whether those regulations really help (or not)?
pdonis 5y ago
If you prevent me from having access to devices, tests, etc. because you're afraid other people might not be as savvy as me, you're punishing me for other people's failings. That is not only unfair, it's counterproductive; the savvier people are exactly the ones who are going to be the most helpful in breaking new ground and figuring out new things. Forbidding them to try because other people are less savvy just means everybody loses.

by ok_dad 5y ago

jcims 5y ago

> On the other hand, it does prevent snake oil sales from screwing over people who aren’t as savvy as you might be. 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.

ok_dad 5y ago
> We have other mechanisms to remedy fraudulent or substantively anti-social behavior. 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.
- BurningFrog 5y ago
  There are two types of errors the FDA can do. Both will cause deaths. 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.
  - netizen-936824 5y ago
    Oddly enough we do have current day examples of people drinking bleach after being told it would help with COVID. The numbers weren't quite that high, though
    - cperciva 5y ago
      Perhaps some cases, but the increase in bleach related poisonings was associated with accidental consumption by young children after parents started sanitizing surfaces more early in the pandemic.
      - shakna 5y ago
        And adult Americans [0] lost to conspiracies and the insanity we've seen popping up around the last couple years. [0] https://www.dallasobserver.com/news/dallas-qanon-cult-members-are-drinking-toxic-chemicals-en-masse-13038506 https://www.dallasobserver.com/news/dallas-qanon-cult-member...
    - BurningFrog 5y ago
      Do we really have documented cases?
  - Retric 5y ago
    You’re vastly overestimating the rate of progress and these delays to come up with millions of deaths. The delay isn’t decades for any one medical treatment and the delay also regularly saves lives. 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.
    - jcims 5y ago
      I’d wager that the numbers in cancer treatment alone are much higher than that. From my personal experience as an advocate for a patient, most doctors seem to be scared to death to get off the ‘standard of care’ rails and *definitely* aren’t comfortable suggesting an alternate treatment plan once the primary doctor has started one. 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.
- jcims 5y ago
  I understand the position, I guess I’m just not as sympathetic to it as I used to be. It used to be ’think of the children’, now it’s becoming ’think of the morons’.
- Dylan16807 5y ago
  But the bleach thing is happening anyway, despite lack of approval. And bleach certainly isn't on the list of what would get through if approval was loosened some.

roenxi 5y ago

Is there evidence that these snake oil people: 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.

ok_dad 5y ago
Read the history of the FDA, my friend. They’re here for a reason. I’m not going to educate you on something you can Google (but probably won’t).
- ahmedalsudani 5y ago
  There's no reason to be this snarky. https://en.wikipedia.org/wiki/Food_and_Drug_Administration#History 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.
  - ok_dad 5y ago
    Did you read it? Literally the FDA was created in response to snake oil remedies killing and injuring people. > 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.

user_7832 5y ago

I'd like to add on to your comment with 2 more points as a Type-1 diabetic: 1. People might be tempted to treat high sugars with insulin/metformin - both of which should be only used on a doctor's prescription, and insulin can outright be (very easily) fatal if you don't know what you're doing. 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.

nradov 5y ago
High blood sugar is now also commonly treated with prescription SGLT2 inhibitors. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/sodium-glucose-cotransporter-2-sglt2-inhibitors https://www.fda.gov/drugs/postmarket-drug-safety-information...
BobbyJo 5y ago
1) People chase therapies like Metformin without seeing their blood sugar. 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.
loeg 5y ago
> People might be tempted to treat high sugars with insulin/metformin - both of which should be only used on a doctor's prescription, and insulin can outright be (very easily) fatal if you don't know what you're doing. Insulin, sure. But why do you think Metformin is dangerous?

spurgu 5y ago

So what's the argument against selling perfectly functioning equipment to people? Why not oversee/regulate the market and allow good products while disallowing snake oil?

ok_dad 5y ago
For one, manufacturing is limited for these products and selling them to people who don’t need it, especially right now, prevents actual diabetics from getting the life saving devices they need.
- spurgu 5y ago
  Wait, weren't we discussing 70's, 80's and 2017 devices as mentioned in the OP? 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?
  - ok_dad 5y ago
    The more I read comments here the more it cements my opinions that people need the FDA even with its foibles; you’re not even reading what I’m actually saying, please stop arguing in bad faith and twisting my words. I’m done here.
    - spurgu 5y ago
      You seem to be missing my points as well. I also said the FDA is needed, but just that regulating "snake oil" is a slippery slope and not really viable in a lot of cases. Like if you try to regulate audiophiles you're going to end up in a downwards spiral of bureaucracy that will never end and will only cause damage and distract from things that would be actually worthwhile regulating.

eru 5y ago

Alas, there seems to be plenty of snake oil in medicine left. How do we know whether those regulations really help (or not)?

pdonis 5y ago

If you prevent me from having access to devices, tests, etc. because you're afraid other people might not be as savvy as me, you're punishing me for other people's failings. That is not only unfair, it's counterproductive; the savvier people are exactly the ones who are going to be the most helpful in breaking new ground and figuring out new things. Forbidding them to try because other people are less savvy just means everybody loses.