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The remedy for this insane injustice is to eliminate the FDA’s monopoly on medical regulation and allow the non-fraudulent production and sale of medical device

The remedy for this insane injustice is to eliminate the FDA’s monopoly on medical regulation and allow the non-fraudulent production and sale of medical devices and drugs to consenting adults. No single group has ultimate authority on what constitutes efficacy and the appropriate amount of risk. So long as they are not violating our consent by lying about their regulatory process, no group has a right to conclude for us what we choose to use and consume to better our health. Until the point that we are free to think for ourselves, we are all subject to the fumbling incompetence and cynical malfeasance of the regulatory cartel. The FDA’s mandate is morally equivalent to the mandate present on every street corner in every hood in America: “Nobody but me and my gang sells drugs on my block.” Hence nobody is surprised when their cocaine is laced with baking soda and sold at 5000% profit margins. Multiply this across all of medicine and it becomes clear why medicine in America is a schlerotic disaster. Meanwhile the political parties are only divided on whether or not the taxpayer should foot the bill...

AnimalMuppet 7y ago
How many people know enough to "think for themselves" in this area? How many are going to know anything beyond what the manufacturers' advertisements say? > Until the point that we are free to think for ourselves, we are all subject to the fumbling incompetence and cynical malfeasance of the regulatory cartel. I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them. > The FDA’s mandate is morally equivalent to the mandate present on every street corner in every hood in America: “Nobody but me and my gang sells drugs on my block.” You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers.
- ibeckermayer 7y ago
  > How many people know enough to "think for themselves" in this area? How many are going to know anything beyond what the manufacturers' advertisements say? For one thing, the fact that other people might not be competent enough to think for themselves is not a justification for banning those who are from doing so. For another, I agree that we need regulatory bodies to ensure our medicine is safe and effective -- just that every individual has a right to decide for themselves which regulatory body to give authority to. Science is premised on the providing logic and evidence for one's claims; a scientific regulatory body would provide logic and evidence for why we should trust their judgement. Using threats (legislative or otherwise) to force everybody in the country to trust their judgements is anti-science -- "because I fucking said so" is not a replacement for logic and evidence. Additionally, as I stated, the standard I'm proposing includes a justified use of force for those defrauding others via false advertising claims. If it can be transparently proven that such claims are unjustified or need further qualification, then providers can rightfully be forced to change their advertising. > I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them. I'm speaking in broad generalities, of course in any enforced institution there will be good and bad actors, and the whole spectrum in between. What I'm railing against is the corrupt political system that allows this sort of tyranny to stifle human freedom without answering probing philosophical questions such as "why am I not allowed to disagree with your determinations?" > You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers. I've already qualified my position that such criminals should be held accountable in the court of law, and in this comment qualified it further in stating that it is reasonable to set up regulatory institutions with processes to ensure safety; they simply can't justifiably be enforced.
  - JohnFen 7y ago
    > For one thing, the fact that other people might not be competent enough to think for themselves is not a justification for banning those who are from doing so. Who is banning anyone from doing their own research or thinking? Not the FDA, as near as I can tell.
    - ibeckermayer 7y ago
      > Who is banning anyone from doing their own research or thinking? Did you read the article? If I think that an insulin pump that automatically regulates insulin levels is a good idea, I'm not allowed to buy or sell it without the FDA's approval. The Loop project can't even buy pre-approved unsecured pumps, augment them, and sell them to people or they will be shut down by force.
      - JohnFen 7y ago
        > Did you read the article? Yes, I did. > I'm not allowed to buy or sell it without the FDA's approval. Yes, but you're talking about commerce there, not the FDA preventing you from thinking for yourself. The FDA can't stop you from developing (or even using the knowledge of others) and building your own medical devices and treatment plans that you use on yourself. You just aren't allowed to put others at risk.
        ibeckermayer 7y ago
        Sure, if you want to say that "I can think whatever I want, I just can't act on it" then they're not preventing me from thinking for myself. Neither is any authoritarian regime for that matter, since they can't stop people from thinking a certain way, just from acting on it. Action follows from thought, infringement on action prevents individuals from thinking and concluding for themselves.
        JohnFen 7y ago
        > if you want to say that "I can think whatever I want, I just can't act on it" As I specifically pointed out, you can act on it. You can make any medical device, or engage in any medical practice, for and to yourself. You just can't sell or distribute it to others.
fucking_tragedy 7y ago
We tried this and got snake oil and Bayer heroin.
- ibeckermayer 7y ago
  If somebody is fraudulently selling snake oil then prove it transparently in court. If somebody is using heroin then its none of your business.
  - fucking_tragedy 7y ago
    > If somebody is fraudulently selling snake oil then prove it transparently in court. I'd rather not live in a society where it takes hundreds, thousands or millions of people becoming sick, injured or dead to eventually bring a class action lawsuit against an entity that was allowed to openly sell snake oil to sick and desperate people for long periods of time. > If somebody is using heroin then its none of your business. It's society's business when a drug with a relatively low LD50 that has fatal interactions with alcohol and many common prescription drugs is sold on drug store shelves as a panacea. Again, we tried this and got Radithor[1] and children's laudanum[2]. [1] https://en.wikipedia.org/wiki/Radithor https://en.wikipedia.org/wiki/Radithor [2] https://wellcomecollection.org/articles/WckzzigAACe3DJPD https://wellcomecollection.org/articles/WckzzigAACe3DJPD
Consultant32452 7y ago
I agree with you here, and go much further to include any drug that is not a systemic risk. A systemic risk might be things like antibiotics, because antibiotic resistant bacteria are a systemic risk. My daughter's asthma inhaler and grandma's heart medication are certainly not. Let me buy these things off the shelf without anyone's permission. Hopefully once we get pot legalized everywhere for recreational use, we can move on to everything else.
- ibeckermayer 7y ago
  Sure, there are difficult cases in this domain that require more complex moral reasoning. But as you say, for drugs that are simply an individual putting something into their own body without infringing on others, there is no justification for one group having monopoly authority to decide whether that's "safe".
bediger4000 7y ago
I'm going to argue against this. Safe food and medicine have been an enormous benefit to everybody: we don't have to risk having food poisoning if we choose the wrong grocery store. Besides that, if we don't regulate the oligopolistic markets we have in everything today (how many pharma companies are there?) we are in enormous danger of everyone losing confidence in food and medicine supplies. Nobody wants that. Instead, I'm going to argue that the entire problem here is a combination of regulatory capture and monopoly power. The onerous regulation is bad for innovation, sure, but it's also great for any participants already in an oligopolistic market. The participants don't have to worry about innovators, who can't possible comply with ridiculous procedures, entering the market and decreasing profits. This is not unlike the defence industry. Boeing, Lockheed-Martin and Raytheon dominate. The bizarre security clearance and DoD procurement process keep out everybody else.
- ibeckermayer 7y ago
  > we don't have to risk having food poisoning if we choose the wrong grocery store Yet we still have food poisoning outbreaks. So this is false, no single institution is omnipotent and without error. This is a soluble problem - force institutions to justify their existence, rather than forcing individuals to abide by their rulings. > if we don't regulate the oligopolistic markets we have in everything today (how many pharma companies are there?) we are in enormous danger of everyone losing confidence in food and medicine supplies. Nobody wants that. Indeed it is an oligopoly, because of the enforced regulatory regime. So your argument is circular - we need enforced regulation because of the oligopoly caused by enforced regulation. Pragmatically, I agree that it would be mayhem if the FDA was simply abolished tomorrow. My solution is to abolish their enforced regulatory power and allow individuals to decide for themselves whether they want to give authority to the FDA exclusively or instead heed the judgements of other bodies that might be more competent.
  - bediger4000 7y ago
    Yes, we still have food poisoning outbreaks. No institution is all-powerful or all-knowing. I'm 100% positive we have fewer food poisonings with the FDA than we'd have without it. Your "this is false" assertion is, while technically true, fairly obviously a case of asking for perfection before doing anything. Given that the Trump administration is scaling regulation of pork products way back (https://www.specialtyfood.com/news/article/trump-administration-increase-self-regulation-pork-industry/ https://www.specialtyfood.com/news/article/trump-administrat...) we get to be part of an experimental test of this! I disagree with you about oligopoly because of regulations. If we enforced sensible anti-trust laws as we did from about 1900-1960, we wouldn't be in the dilemma of having 3 pharma companies, or 3 grocery store companies, or 1 ISP. Yes, the regulatory environment is a result of capture and oligopoly, but without the regulation, the oligopolies, which have close to zero market forces to check them, would really abuse the consumers. Asserting that this is circular is kind of like saying that without ticks, rabbits wouldn't have need of blood. Ticks, (and/or similar blood suckers) co-evolve with their hosts. Regulatory environments, particularly when the agency has been captured, and I'm sure we can agree that the FDA has been captured, co-evolve.
doesnt_know 7y ago
Anti-vax is what happens when people "think for themselves". Medical regulation doesn't solve every problem, but it solves many problems that we would have in addition to our current ones.

AnimalMuppet 7y ago

How many people know enough to "think for themselves" in this area? How many are going to know anything beyond what the manufacturers' advertisements say? > Until the point that we are free to think for ourselves, we are all subject to the fumbling incompetence and cynical malfeasance of the regulatory cartel. I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them. > The FDA’s mandate is morally equivalent to the mandate present on every street corner in every hood in America: “Nobody but me and my gang sells drugs on my block.” You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers.

ibeckermayer 7y ago
> How many people know enough to "think for themselves" in this area? How many are going to know anything beyond what the manufacturers' advertisements say? For one thing, the fact that other people might not be competent enough to think for themselves is not a justification for banning those who are from doing so. For another, I agree that we need regulatory bodies to ensure our medicine is safe and effective -- just that every individual has a right to decide for themselves which regulatory body to give authority to. Science is premised on the providing logic and evidence for one's claims; a scientific regulatory body would provide logic and evidence for why we should trust their judgement. Using threats (legislative or otherwise) to force everybody in the country to trust their judgements is anti-science -- "because I fucking said so" is not a replacement for logic and evidence. Additionally, as I stated, the standard I'm proposing includes a justified use of force for those defrauding others via false advertising claims. If it can be transparently proven that such claims are unjustified or need further qualification, then providers can rightfully be forced to change their advertising. > I've worked for FDA-regulated medical device manufacturers twice. I didn't enjoy the experience, and no one would call them efficient, but they do not deserve the venom you are pouring on them. I'm speaking in broad generalities, of course in any enforced institution there will be good and bad actors, and the whole spectrum in between. What I'm railing against is the corrupt political system that allows this sort of tyranny to stifle human freedom without answering probing philosophical questions such as "why am I not allowed to disagree with your determinations?" > You rather badly need to re-calibrate your moral compass. Their mandate is "Nobody gets to poison people on my block. Nobody gets to create junk devices that kill people on my block." That is in no way morally equivalent to a gang of drug dealers. I've already qualified my position that such criminals should be held accountable in the court of law, and in this comment qualified it further in stating that it is reasonable to set up regulatory institutions with processes to ensure safety; they simply can't justifiably be enforced.
- JohnFen 7y ago
  > For one thing, the fact that other people might not be competent enough to think for themselves is not a justification for banning those who are from doing so. Who is banning anyone from doing their own research or thinking? Not the FDA, as near as I can tell.
  - ibeckermayer 7y ago
    > Who is banning anyone from doing their own research or thinking? Did you read the article? If I think that an insulin pump that automatically regulates insulin levels is a good idea, I'm not allowed to buy or sell it without the FDA's approval. The Loop project can't even buy pre-approved unsecured pumps, augment them, and sell them to people or they will be shut down by force.
    - JohnFen 7y ago
      > Did you read the article? Yes, I did. > I'm not allowed to buy or sell it without the FDA's approval. Yes, but you're talking about commerce there, not the FDA preventing you from thinking for yourself. The FDA can't stop you from developing (or even using the knowledge of others) and building your own medical devices and treatment plans that you use on yourself. You just aren't allowed to put others at risk.
      - ibeckermayer 7y ago
        Sure, if you want to say that "I can think whatever I want, I just can't act on it" then they're not preventing me from thinking for myself. Neither is any authoritarian regime for that matter, since they can't stop people from thinking a certain way, just from acting on it. Action follows from thought, infringement on action prevents individuals from thinking and concluding for themselves.
        JohnFen 7y ago
        > if you want to say that "I can think whatever I want, I just can't act on it" As I specifically pointed out, you can act on it. You can make any medical device, or engage in any medical practice, for and to yourself. You just can't sell or distribute it to others.

fucking_tragedy 7y ago

We tried this and got snake oil and Bayer heroin.

ibeckermayer 7y ago
If somebody is fraudulently selling snake oil then prove it transparently in court. If somebody is using heroin then its none of your business.
- fucking_tragedy 7y ago
  > If somebody is fraudulently selling snake oil then prove it transparently in court. I'd rather not live in a society where it takes hundreds, thousands or millions of people becoming sick, injured or dead to eventually bring a class action lawsuit against an entity that was allowed to openly sell snake oil to sick and desperate people for long periods of time. > If somebody is using heroin then its none of your business. It's society's business when a drug with a relatively low LD50 that has fatal interactions with alcohol and many common prescription drugs is sold on drug store shelves as a panacea. Again, we tried this and got Radithor[1] and children's laudanum[2]. [1] https://en.wikipedia.org/wiki/Radithor https://en.wikipedia.org/wiki/Radithor [2] https://wellcomecollection.org/articles/WckzzigAACe3DJPD https://wellcomecollection.org/articles/WckzzigAACe3DJPD

Consultant32452 7y ago

I agree with you here, and go much further to include any drug that is not a systemic risk. A systemic risk might be things like antibiotics, because antibiotic resistant bacteria are a systemic risk. My daughter's asthma inhaler and grandma's heart medication are certainly not. Let me buy these things off the shelf without anyone's permission. Hopefully once we get pot legalized everywhere for recreational use, we can move on to everything else.

ibeckermayer 7y ago
Sure, there are difficult cases in this domain that require more complex moral reasoning. But as you say, for drugs that are simply an individual putting something into their own body without infringing on others, there is no justification for one group having monopoly authority to decide whether that's "safe".

bediger4000 7y ago

I'm going to argue against this. Safe food and medicine have been an enormous benefit to everybody: we don't have to risk having food poisoning if we choose the wrong grocery store. Besides that, if we don't regulate the oligopolistic markets we have in everything today (how many pharma companies are there?) we are in enormous danger of everyone losing confidence in food and medicine supplies. Nobody wants that. Instead, I'm going to argue that the entire problem here is a combination of regulatory capture and monopoly power. The onerous regulation is bad for innovation, sure, but it's also great for any participants already in an oligopolistic market. The participants don't have to worry about innovators, who can't possible comply with ridiculous procedures, entering the market and decreasing profits. This is not unlike the defence industry. Boeing, Lockheed-Martin and Raytheon dominate. The bizarre security clearance and DoD procurement process keep out everybody else.

ibeckermayer 7y ago
> we don't have to risk having food poisoning if we choose the wrong grocery store Yet we still have food poisoning outbreaks. So this is false, no single institution is omnipotent and without error. This is a soluble problem - force institutions to justify their existence, rather than forcing individuals to abide by their rulings. > if we don't regulate the oligopolistic markets we have in everything today (how many pharma companies are there?) we are in enormous danger of everyone losing confidence in food and medicine supplies. Nobody wants that. Indeed it is an oligopoly, because of the enforced regulatory regime. So your argument is circular - we need enforced regulation because of the oligopoly caused by enforced regulation. Pragmatically, I agree that it would be mayhem if the FDA was simply abolished tomorrow. My solution is to abolish their enforced regulatory power and allow individuals to decide for themselves whether they want to give authority to the FDA exclusively or instead heed the judgements of other bodies that might be more competent.
- bediger4000 7y ago
  Yes, we still have food poisoning outbreaks. No institution is all-powerful or all-knowing. I'm 100% positive we have fewer food poisonings with the FDA than we'd have without it. Your "this is false" assertion is, while technically true, fairly obviously a case of asking for perfection before doing anything. Given that the Trump administration is scaling regulation of pork products way back (https://www.specialtyfood.com/news/article/trump-administration-increase-self-regulation-pork-industry/ https://www.specialtyfood.com/news/article/trump-administrat...) we get to be part of an experimental test of this! I disagree with you about oligopoly because of regulations. If we enforced sensible anti-trust laws as we did from about 1900-1960, we wouldn't be in the dilemma of having 3 pharma companies, or 3 grocery store companies, or 1 ISP. Yes, the regulatory environment is a result of capture and oligopoly, but without the regulation, the oligopolies, which have close to zero market forces to check them, would really abuse the consumers. Asserting that this is circular is kind of like saying that without ticks, rabbits wouldn't have need of blood. Ticks, (and/or similar blood suckers) co-evolve with their hosts. Regulatory environments, particularly when the agency has been captured, and I'm sure we can agree that the FDA has been captured, co-evolve.

doesnt_know 7y ago

Anti-vax is what happens when people "think for themselves". Medical regulation doesn't solve every problem, but it solves many problems that we would have in addition to our current ones.