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My view is that people should be allowed to opt out of FDA regulation if they wish to do so. It's my body; I should be allowed to put anything I want into it.

My view is that people should be allowed to opt out of FDA regulation if they wish to do so. It's my body; I should be allowed to put anything I want into it. It took 10 years for the first beta blockers to be approved in the US after they were in use in Europe. In that amount of time, thousands of Americans died for lack of the drugs. It's hard to distinguish this from mass murder, or at least mass manslaughter.

earl 16y ago
And Thalidomide wasn't approved in the US whereas it was approved in Europe and Canada. So... your point is stupid.
- deleted 16y ago
  [deleted]
- jsn 16y ago
  No, it's not, but your point definitely is irrelevant. You see, it's my body, so I can put whatever I want in it, be it aspirin, heroin, thalidomide or cyanide. And yeah, I may wish to make an educated choice about that, but then again, I don't have to.
  - pyre 16y ago
    True, but when you're talking medicines, you may not have a choice in the matter. e.g. You come into the emergency room unconscious, what medicines should the doctors be allowed to use?
    - jsn 16y ago
      Basically, if someone is going to make a decision affecting my body while I'm unconscious, I'd rather have someone I picked for that job to do it (like, I don't know, my doctor or my wife or my dad or my friend or even my insurance company) than some bureaucrat in FDA. But that's not quite the issue in question, eh? My understanding is, you can't get the unapproved anti-venom even if you are conscious and you are about to die without it anyway, by doctors opinion.
      - pyre 16y ago
        I realize that you still can't get it when you are conscious. I'm just saying that 'personal choice' isn't the only weighing factor here. If you come into the emergency room and you are unconscious, who says that you are with someone (wife,friend,etc) or that there is enough time to try and get in touch with your doctor? I personally think that the FDA approval process is bogus too. I'm just trying to expand the discussion a bit.
        jsn 16y ago
        I was just trying not to drift too much into complicated parts of the problem, since the society is obviously unable to fix even the most obvious and simple parts of it. Yeah, maybe there should be some rules about corner cases like that (what to do with you if you are unconscious and there is nobody to ask about what you'd want to be done to you). And maybe one way to get those rules written and enforced is to have people on government payroll for that. Or maybe we should just leave it to the ER folks. But, frankly, I think it would be nice to fix the obvious big wrongs first, and worry about all this stuff later.
  - nitrogen 16y ago
    Since you include heroin and cyanide, would you have some kind of provision that prohibits people from taking certain substances if they've demonstrated by their behavior that those substances would cause them to harm other members of society? In other words, should we allow susceptible people to become junkies if they end up doing something really really bad while they're under the influence?
    - jsn 16y ago
      I'm not sure there is a one-size-fits-all solution to that. But, in general, I think that what matters is the real damage done. I mean, if you do harm others, you should be punished/restricted, and if you do harm others repeatedly under the influence of some substance (be it snorted cocaine or internally produced adrenaline), you should perhaps be punished/restricted more. But the punishment/restriction should always be a response to the harm done to others, not to whatever the person does to her own body.
- Alex3917 16y ago
  Millions of people have died because the government has banned certain drugs. Whereas the number of people who have died because of a drug not being banned is zero. It seems like a clear tradeoff to me.
  - pyre 16y ago
    > Whereas the number of people who have died because of a drug not being banned is zero. I'm sure this is a debatable 'fact'/statistic.
  - prodigal_erik 16y ago
    http://en.wikipedia.org/wiki/Fen-phen http://en.wikipedia.org/wiki/Fen-phen had a body count before it was banned. Such cases are rare, but that means the system is doing at least part of its job.
    - Alex3917 16y ago
      People died because they took a dangerous drug. They didn't die because the drug wasn't illegal. If you want to cut down the number of people taking dangerous drugs, ban doctors from prescribing non FDA-approved drugs and ban companies from marketing them. However, I have only contempt for people who want to put their fellow citizens in jail for making their own medical decisions.
      - devinj 16y ago
        "guns don't kill people, the pauli exclusion principle kills people"
  - alaithea 16y ago
    http://en.wikipedia.org/wiki/Rofecoxib#Adverse_cardiovascular_events http://en.wikipedia.org/wiki/Rofecoxib#Adverse_cardiovascula...
- jerf 16y ago
  When you measure only the costs of one side and only the benefits of the other, the conclusion is predetermined, and of no value. How about you engage the question of whether the costs and benefits of our current policy outweigh the costs and benefits of a looser policy directly, instead of just tossing a rhetorical hand grenade into the debate ("look! mangled babies!") and running away? It would look something like this: "The number of thalidomide birth defects estimates range from 10,000 to 20,000 according to Wikipedia. Given the rate of cancer death in this country, a net one year delay applied across all effective therapies compounded across many years almost certainly outweighs your one example. Excessively liberal medicine policy may kill and maim, but so does excessively conservative policy; it's not a pure win by any means. Are you so sure that our policy is really the best policy?" This isn't a question you can actually determine the best answer to with a series of anecdotes. You have to actually do a statistical analysis. I have not done this statistical analysis, so all I can say is something like "I'd bet money we're being too conservative", or "My libertarian leanings lead me to say we should have a more liberal acceptance policy on the grounds of personal freedom", but just screaming about deformed babies with no other analysis like this is an emotional tactic that should be replaced with something better. Too many people's lives are on the line for this debate to be shut down with "won't someone please think of the babies?"
  - pyre 16y ago
    It's also effectively a non-issue. Why not slap a big "THIS IS NOT TESTED TO BE SAFE FOR PREGNANT WOMEN" label on the thing? I mean doctors don't recommend ibuprofen for pregnant women, but mostly because there are no studies on the effects of ibuprofen on unborn babies. We don't out-right ban ibuprofen just because we don't know how it will effect women/babies during pregnancy.
    - infinite8s 16y ago
      If there was no FDA, you'd basically need to slap a label on that said - "This is not tested to be safe for anything", since it's the FDA that mandates all the safety testing.
  - Retric 16y ago
proee 16y ago
It's not that simple. If they allow the sale of non regulated drugs then you'll have a 10x increase in commercials on TV trying to sell you an untested and unregulated "purple pill". The fine print will say "this drug has not been tested and is not approved by the FDA. It may cause death or create an uncontrolled viral outbreak..." The drug will sell like hotcakes though because the commercials will have lots of happy-smiley people and the distributor will get a healthy 80% profit margin on the sales. There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption.
- elidourado 16y ago
  If that's really your concern, then why not at least let college graduates opt out? Or people holding PhDs? My suspicion is that many people would oppose this because it disadvantages the uneducated, but of course you can't have it both ways. Either regulation is good for the uneducated or it is not.
  - eru 16y ago
    > Or people holding PhDs? In which fields? You are entering a mine field. > Either regulation is good for the uneducated or it is not. There could be different kinds of regulation.
- xiaoma 16y ago
  The US already has that situation in the supplements industry and while heavily-advertised weight-loss/muscle/hair supplements are annoying, it's not that bad. The cost of not getting valuable drugs is underestimated since people only hear about it in rare cases such as this one, whereas dangerous treatments generate a lot of media coverage.
  - carbocation 16y ago
    Right, weight loss supplements are OK because hypertension and cardiomyopathy (along with the occasional sudden death) are no problem? At the end of the day, the FDA needs to carefully regulate the market not because dumb people need them to, but because smart people such as most HNers do.
RyanMcGreal 16y ago
>It took 10 years for the first beta blockers to be approved in the US after they were in use in Europe. Yet Europe has drug regulation. Maybe the problem isn't regulation as such, but the way regulation works in the US.
nooneelse 16y ago
"It's my body; I should be allowed to put anything I want into it." It is my understanding that many drugs are not entirely metabolized/naturalized by the first person they enter. So the presupposition you are working with isn't entirely true.
varjag 16y ago
OK, who will give you prescriptions for non-FDA drugs then? Your physician, only to be sued into oblivion when you die? Or would you rather prescribe them yourself too?

earl 16y ago

And Thalidomide wasn't approved in the US whereas it was approved in Europe and Canada. So... your point is stupid.

deleted 16y ago
[deleted]
jsn 16y ago
No, it's not, but your point definitely is irrelevant. You see, it's my body, so I can put whatever I want in it, be it aspirin, heroin, thalidomide or cyanide. And yeah, I may wish to make an educated choice about that, but then again, I don't have to.
- pyre 16y ago
  True, but when you're talking medicines, you may not have a choice in the matter. e.g. You come into the emergency room unconscious, what medicines should the doctors be allowed to use?
  - jsn 16y ago
    Basically, if someone is going to make a decision affecting my body while I'm unconscious, I'd rather have someone I picked for that job to do it (like, I don't know, my doctor or my wife or my dad or my friend or even my insurance company) than some bureaucrat in FDA. But that's not quite the issue in question, eh? My understanding is, you can't get the unapproved anti-venom even if you are conscious and you are about to die without it anyway, by doctors opinion.
    - pyre 16y ago
      I realize that you still can't get it when you are conscious. I'm just saying that 'personal choice' isn't the only weighing factor here. If you come into the emergency room and you are unconscious, who says that you are with someone (wife,friend,etc) or that there is enough time to try and get in touch with your doctor? I personally think that the FDA approval process is bogus too. I'm just trying to expand the discussion a bit.
      - jsn 16y ago
        I was just trying not to drift too much into complicated parts of the problem, since the society is obviously unable to fix even the most obvious and simple parts of it. Yeah, maybe there should be some rules about corner cases like that (what to do with you if you are unconscious and there is nobody to ask about what you'd want to be done to you). And maybe one way to get those rules written and enforced is to have people on government payroll for that. Or maybe we should just leave it to the ER folks. But, frankly, I think it would be nice to fix the obvious big wrongs first, and worry about all this stuff later.
- nitrogen 16y ago
  Since you include heroin and cyanide, would you have some kind of provision that prohibits people from taking certain substances if they've demonstrated by their behavior that those substances would cause them to harm other members of society? In other words, should we allow susceptible people to become junkies if they end up doing something really really bad while they're under the influence?
  - jsn 16y ago
    I'm not sure there is a one-size-fits-all solution to that. But, in general, I think that what matters is the real damage done. I mean, if you do harm others, you should be punished/restricted, and if you do harm others repeatedly under the influence of some substance (be it snorted cocaine or internally produced adrenaline), you should perhaps be punished/restricted more. But the punishment/restriction should always be a response to the harm done to others, not to whatever the person does to her own body.
Alex3917 16y ago
Millions of people have died because the government has banned certain drugs. Whereas the number of people who have died because of a drug not being banned is zero. It seems like a clear tradeoff to me.
- pyre 16y ago
  > Whereas the number of people who have died because of a drug not being banned is zero. I'm sure this is a debatable 'fact'/statistic.
- prodigal_erik 16y ago
  http://en.wikipedia.org/wiki/Fen-phen http://en.wikipedia.org/wiki/Fen-phen had a body count before it was banned. Such cases are rare, but that means the system is doing at least part of its job.
  - Alex3917 16y ago
    People died because they took a dangerous drug. They didn't die because the drug wasn't illegal. If you want to cut down the number of people taking dangerous drugs, ban doctors from prescribing non FDA-approved drugs and ban companies from marketing them. However, I have only contempt for people who want to put their fellow citizens in jail for making their own medical decisions.
    - devinj 16y ago
      "guns don't kill people, the pauli exclusion principle kills people"
- alaithea 16y ago
  http://en.wikipedia.org/wiki/Rofecoxib#Adverse_cardiovascular_events http://en.wikipedia.org/wiki/Rofecoxib#Adverse_cardiovascula...
jerf 16y ago
When you measure only the costs of one side and only the benefits of the other, the conclusion is predetermined, and of no value. How about you engage the question of whether the costs and benefits of our current policy outweigh the costs and benefits of a looser policy directly, instead of just tossing a rhetorical hand grenade into the debate ("look! mangled babies!") and running away? It would look something like this: "The number of thalidomide birth defects estimates range from 10,000 to 20,000 according to Wikipedia. Given the rate of cancer death in this country, a net one year delay applied across all effective therapies compounded across many years almost certainly outweighs your one example. Excessively liberal medicine policy may kill and maim, but so does excessively conservative policy; it's not a pure win by any means. Are you so sure that our policy is really the best policy?" This isn't a question you can actually determine the best answer to with a series of anecdotes. You have to actually do a statistical analysis. I have not done this statistical analysis, so all I can say is something like "I'd bet money we're being too conservative", or "My libertarian leanings lead me to say we should have a more liberal acceptance policy on the grounds of personal freedom", but just screaming about deformed babies with no other analysis like this is an emotional tactic that should be replaced with something better. Too many people's lives are on the line for this debate to be shut down with "won't someone please think of the babies?"
- pyre 16y ago
  It's also effectively a non-issue. Why not slap a big "THIS IS NOT TESTED TO BE SAFE FOR PREGNANT WOMEN" label on the thing? I mean doctors don't recommend ibuprofen for pregnant women, but mostly because there are no studies on the effects of ibuprofen on unborn babies. We don't out-right ban ibuprofen just because we don't know how it will effect women/babies during pregnancy.
  - infinite8s 16y ago
    If there was no FDA, you'd basically need to slap a label on that said - "This is not tested to be safe for anything", since it's the FDA that mandates all the safety testing.
- Retric 16y ago

proee 16y ago

It's not that simple. If they allow the sale of non regulated drugs then you'll have a 10x increase in commercials on TV trying to sell you an untested and unregulated "purple pill". The fine print will say "this drug has not been tested and is not approved by the FDA. It may cause death or create an uncontrolled viral outbreak..." The drug will sell like hotcakes though because the commercials will have lots of happy-smiley people and the distributor will get a healthy 80% profit margin on the sales. There's some comfort in knowing that a non-profit agency is looking into the safety of a drug before it goes out to the public for consumption.

elidourado 16y ago
If that's really your concern, then why not at least let college graduates opt out? Or people holding PhDs? My suspicion is that many people would oppose this because it disadvantages the uneducated, but of course you can't have it both ways. Either regulation is good for the uneducated or it is not.
- eru 16y ago
  > Or people holding PhDs? In which fields? You are entering a mine field. > Either regulation is good for the uneducated or it is not. There could be different kinds of regulation.
xiaoma 16y ago
The US already has that situation in the supplements industry and while heavily-advertised weight-loss/muscle/hair supplements are annoying, it's not that bad. The cost of not getting valuable drugs is underestimated since people only hear about it in rare cases such as this one, whereas dangerous treatments generate a lot of media coverage.
- carbocation 16y ago
  Right, weight loss supplements are OK because hypertension and cardiomyopathy (along with the occasional sudden death) are no problem? At the end of the day, the FDA needs to carefully regulate the market not because dumb people need them to, but because smart people such as most HNers do.

RyanMcGreal 16y ago

>It took 10 years for the first beta blockers to be approved in the US after they were in use in Europe. Yet Europe has drug regulation. Maybe the problem isn't regulation as such, but the way regulation works in the US.

nooneelse 16y ago

"It's my body; I should be allowed to put anything I want into it." It is my understanding that many drugs are not entirely metabolized/naturalized by the first person they enter. So the presupposition you are working with isn't entirely true.

varjag 16y ago

OK, who will give you prescriptions for non-FDA drugs then? Your physician, only to be sued into oblivion when you die? Or would you rather prescribe them yourself too?