6 ms·

Just as an example: 9% of the cases of Idiosyncratic Drug-induced Liver Injury is self-harm caused by people taking non-regulated dietary supplements: https://

by badsock 10y ago

Just as an example: 9% of the cases of Idiosyncratic Drug-induced Liver Injury is self-harm caused by people taking non-regulated dietary supplements: https://www.ncbi.nlm.nih.gov/pubmed/18955056 https://www.ncbi.nlm.nih.gov/pubmed/18955056 You have a theory that the average person will wisely assume the responsibility to vet the health effects of what they consume, but empirical reality disagrees with your theory. Right now people are injuring themselves with products at the margin of regulation. There's a societal cost for lots of people injuring themselves, and offloading the responsibility of researching safety to the average consumer will cause fear and superstition, limiting people's willingness to try new products, and I would argue that that reduces innovation. Regulation in this area has been a net societal benefit.

azinman2 10y ago
Don't forget that marketing budgets for pharmaceuticals are also huge. The average person has no chance. The constant bombardment already means people go to their doctor asking for Rx by name even without understanding the medical need or if they're right for it. Now remove regulation... the warnings basically just blur into the background. Already we get so many warnings on prescriptions that they just turn into nothing because people become so habituated to them. It's identical to the paradox that is windows/browser security -- the more you warn, the more people just click through and ignore.
- RangerScience 10y ago
  Hmm. Could you then disallow any advertising of drug while you're still without FDA endorsement? Like how you're not allowed to advertise cigarettes. I suspect this line of thinking just leads to too many problems, however.
  - frisco 10y ago
    Not too many problems, that's in general exactly how it works today. FDA approvals are generally marketing approvals: what you're allowed to advertise your drug for and to who. Physicians can do more or less whatever they want in terms of prescribing things. (Drugs which aren't approved for marketing for anything yet are a little different, but can still be made available as an "investigational" drug, which is a much lower, primarily safety, bar.)
  - deleted 10y ago
    [deleted]
  - teddyh 10y ago
    Yes, it’s possible to do this. You may be surprised to hear that the USA is one of only two countries on the entire planet which it’s even legal to advertise drugs. All others outlaw it completely.
    - Sacho 10y ago
      Indeed, that was surprising to hear, and a quick google search found me many countries in Europe where advertising drugs is legal, within some restrictive framework. Examples: Spain http://uk.practicallaw.com/0-618-5403#a202338 http://uk.practicallaw.com/0-618-5403#a202338 France http://uk.practicallaw.com/2-618-6699 http://uk.practicallaw.com/2-618-6699 )
      - comex 10y ago
        Both of those links say that there's a total ban on advertising prescription drugs to consumers, which is more specific than what the parent said but still very broad.
        teddyh 10y ago
        I’m sorry, yes, I should have specified prescription drugs, as that is what I meant. In context, though, this was what was discussed by the grandparent post: “[…] people go to their doctor asking for Rx by name […]”.
    - pessimizer 10y ago
      Before 1997 it was impractical to advertise them, though. You couldn't mention both the name of the drug and what it was for in an ad without including the entire warning label text. The deregulation was another Clinton thing, and its main beneficiary was the SSRIs.
      - azinman2 10y ago
        I believe that's still the case -- which is why we get all those commercials with happy people having family moments while a voice in the background quickly announces "if you have experience any of the following symptoms head to the ER immediately."
- baddox 10y ago
  Don't forget that lobbying budgets for pharmaceuticals are also huge. I'd rather pharmaceuticals spend money to show me ads while I still get to make my own choices than spend money to buy laws that restrict my choices.
- paulryanrogers 10y ago
  "Don't forget that marketing budgets for pharmaceuticals are also huge" Why is it advertising regulated drugs to uninformed consumers is legal?
zdean 10y ago
The issue with non-regulated dietary supplements may well be caused by the current state of regulation (this is strictly my own opinion/observation). In the current state of things, we've grown accustomed to seeing warnings when the government thinks there is a potential danger with a particular FDA regulated drug. So perhaps the lack of warnings with supplements is giving people a false sense of security about the dietary supplements...ie, "if they were dangerous, surely there'd be a warning". If, as the parent comment suggests, the paradigm shifts so that the government's position is one of several factors to consider, perhaps then people would look at supplements with a greater degree of caution and suspicion. In other words, changing the paradigm may change people's behavior in terms of how they approach both drugs and supplements.
spqr0a1 10y ago
Idiosyncratic Drug-induced Liver Injury (DILI) is only 13-20% of all DILI. The other ~80% being pharmacological. About 40% of all acute liver failure is caused by acetaminophen. http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.html http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.... Meaning a single FDA approved over-the-counter drug is responsible for over 20 times as much liver failure as all dietary supplements. Some regulation may be beneficial but the current policies are clearly suboptimal.
- ejstronge 10y ago
  Acetaminophen is a interesting example - it's a very (centuries) old drug that predates the regulatory framework we have today. Some scholars (see ref. 1 for some history) suggest that it would not be approved by today's FDA. It's thus a poor selection if one wishes to discredit the FDA's efficacy; indeed, some other widely-used therapeutics (e.g., aspirin) came into use before drug efficacy was required for new drug approval. At the same time, there are numerous examples of drugs either not approved by the FDA or withdrawn from the US market by the FDA. It's not clear how less regulation would achieve this type of nation-wide safety benefit. [1] http://s3.documentcloud.org/documents/793731/mcneil-history-by-students.pdf http://s3.documentcloud.org/documents/793731/mcneil-history-...
dcosson 10y ago
I've been thinking recently about government regulations like this and about where it should end. Why are we so sure that we can't trust people to make an educated decision about an experimental drug or any of the many other things we regulate, many of which only impact themselves and don't put the general public at risk in any way. Yet one of our most deeply held values is trusting them to make an educated decision about who should run the country. It's certainly not any less complex of a topic when you consider all of the policy areas that there are to evaluate politicians across.
baddox 10y ago
You didn't show any evidence of the FDA being a net benefit. You only showed that the FDA probably could have reduced that specific type of liver injury by regulating those specific supplements. But the government is not magic, and the FDA almost certainly has also caused injuries by overly or erroneously regulating other things. I have no idea what the net effect is, but you certainly haven't shown it to be positive.
- ejstronge 10y ago
  I'm curious about your assertion of 'overly' regulating things leading to a net negative effect. Are there specific examples you're considering?
  - baddox 10y ago
    Marijuana would be the most obvious example.
    - ejstronge 10y ago
      Sorry to reply so late. I think we would do well to separate concerns about recreational drugs from the FDA's regulation of pharmaceuticals. I totally agree that our regulation of marijuana (when compared to similar substances like cigarettes) has been problematic. Are there examples of pharmaceuticals you were considering?
      - baddox 10y ago
        I meant medical marijuana.
oh_sigh 10y ago
What dietary supplements can cause liver injury?
- ageofwant 10y ago
  Vitamin A, typically. Or more generally fat-soluble vitamins. The label usually warns you.
  - oh_sigh 10y ago
    Oh, duh. People don't know that? That's why I refuse to eat polar bear liver.
lend000 10y ago
And people will also choose to eat potato chips, not exercise, smoke, and drink heavily. You can't protect people from themselves, and even if it was an ethical government job to do so, i.e. take away people's freedoms because the government says it knows better, like with marijuana (I am REALLY humoring you, if you can't tell), there is no practical argument either. How much do you think your high estimate of X% who get sick by their own incompetence (which of course goes down significantly when people realize that they shouldn't blindly trust everything in our markets -- that blind, oft-misguided trust is another side effect of the FDA/USDA) will be DWARFED by the percentage of people saved by life saving drugs that make it to market faster/would otherwise be blocked. Do you know how many people the FDA has sentenced to die directly by rejecting appeals from terminally ill patients to get access to experimental drugs/procedures? Not to mention the indirect damage of delaying medicinal progress...
- djsumdog 10y ago
  True, there are always people who will do that. I try to eat very low-carb and it's helped my heath dramatically, but even I occasionally will have a burger or real pasta. The issue is education. It's very difficult to tell what is healthy and what isn't. There is a lot of research coming out that shows us sugar and starches are very bad for us. The stress from those carbs can damage our arteries and is what allows cholesterol to build. The industry has a vested interest in people not knowing/believing in that. Sugar and HF Corn Syrup is a massive industry. Soda companies have been losing money as people finally move away and now we start to see the tides change. Regardless, we need good education about what is and isn't health. Otherwise people struggle with weight and just get frustrated and resolve themselves to eat unhealthy because nothing seems to help reduce their weight or cravings.
  - kyriakos 10y ago
    How's a burger carbs btw? Unless you mean the bun and not the actual patty.
    - kyriakos 10y ago
ageofwant 10y ago
These kind of context-less banding about of figures always serve the point the bander is trying to make, and rarely the truth. It leaves out the fact, for example, that regulated medicine is responsible for the rest. If we exclude approved regulated alcohol, the liver damage caused by unregulated 'medicine' is almost noise.
Veratyr 10y ago
> You have a theory that the average person will wisely assume the responsibility to vet the health effects of what they consume, but empirical reality disagrees with your theory. Right now people are injuring themselves with products at the margin of regulation. I know this is an incredibly callous opinion but isn't this natural selection at work? People even go further and knowingly partake of substances known to be harmful (cigarettes). We don't stop them from that, why should we stop them from consuming medication that hasn't yet been deemed safe? Educating and providing support for those that need it I agree with but if people freely and knowingly choose to act in a self destructive manner with a sound mind, I'm not convinced it benefits society or themselves to forcibly preserve their life.
- darpa_escapee 10y ago
  Isn't murder survival of the fittest? We as a society have decided that, generally, profiting from causing harm to others incentives bad things. I don't want cough medicine that might stop my breathing, but heroin was regularly sold as just that before the FDA. History has shown that without regulation the quality, efficacy, composition, safety and side-effect profile of drugs might stray from reality because of market incentives. The unfortunate truth is that sometimes it is more profitable if those five things are ignored and people get hurt or die. Hence, regulation. > People even go further and knowingly partake of substances known to be harmful (cigarettes). Tobacco products are heavily regulated. One could argue that because of lobbying and the amounts of wealth involved, that tobacco companies have been spared some of the stronger regulations they could have faced.
  - Veratyr 10y ago
    > Isn't murder survival of the fittest? Murder is bad for society, as people who can benefit society through say their knowledge of medicine or physics aren't adept at self defence. A similar argument could be made that people who aren't very good at taking care of themselves are valuable to society somehow and should be protected from idiotic self-harm but I believe a person's autonomy trumps society's interest in preserving whatever value they have. > I don't want cough medicine that might stop my breathing, but heroin was regularly sold as just that before the FDA. Heroin was sold as cough medicine that might stop your breathing? If it tells you you might die and you choose to ingest it, that's on you. If you choose to play Russian Roulette, nobody's stopping you. In case it wasn't sold with a warning that it might stop your breathing, you could have chosen to verify that it did what you expected before ingesting it. The modern FDA could also warn of the dangers without forbidding the sale of the substance. > Tobacco products are heavily regulated. They may be regulated but any adult can still choose to partake of however much they like regardless of the damage to their health.
BurningFrog 10y ago
From your link: RESULTS: DILI was caused by a single prescription medication in 73% of the cases, by dietary supplements in 9%, and by multiple agents in 18%. More than 100 different agents were associated with DILI; antimicrobials (45.5%) and central nervous system agents (15%) were the most common. CONCLUSIONS: DILI is caused by a wide array of medications, herbal supplements, and dietary supplements. Antibiotics are the single largest class of agents that cause DILI. So FDA approved drugs cause 73% of these liver injuries, while unregulated supplements cause 9%. I don't understand how that is an argument for FDA regulation?

by badsock 10y ago

azinman2 10y ago

Don't forget that marketing budgets for pharmaceuticals are also huge. The average person has no chance. The constant bombardment already means people go to their doctor asking for Rx by name even without understanding the medical need or if they're right for it. Now remove regulation... the warnings basically just blur into the background. Already we get so many warnings on prescriptions that they just turn into nothing because people become so habituated to them. It's identical to the paradox that is windows/browser security -- the more you warn, the more people just click through and ignore.

RangerScience 10y ago
Hmm. Could you then disallow any advertising of drug while you're still without FDA endorsement? Like how you're not allowed to advertise cigarettes. I suspect this line of thinking just leads to too many problems, however.
- frisco 10y ago
  Not too many problems, that's in general exactly how it works today. FDA approvals are generally marketing approvals: what you're allowed to advertise your drug for and to who. Physicians can do more or less whatever they want in terms of prescribing things. (Drugs which aren't approved for marketing for anything yet are a little different, but can still be made available as an "investigational" drug, which is a much lower, primarily safety, bar.)
- deleted 10y ago
  [deleted]
- teddyh 10y ago
  Yes, it’s possible to do this. You may be surprised to hear that the USA is one of only two countries on the entire planet which it’s even legal to advertise drugs. All others outlaw it completely.
  - Sacho 10y ago
    Indeed, that was surprising to hear, and a quick google search found me many countries in Europe where advertising drugs is legal, within some restrictive framework. Examples: Spain http://uk.practicallaw.com/0-618-5403#a202338 http://uk.practicallaw.com/0-618-5403#a202338 France http://uk.practicallaw.com/2-618-6699 http://uk.practicallaw.com/2-618-6699 )
    - comex 10y ago
      Both of those links say that there's a total ban on advertising prescription drugs to consumers, which is more specific than what the parent said but still very broad.
      - teddyh 10y ago
        I’m sorry, yes, I should have specified prescription drugs, as that is what I meant. In context, though, this was what was discussed by the grandparent post: “[…] people go to their doctor asking for Rx by name […]”.
  - pessimizer 10y ago
    Before 1997 it was impractical to advertise them, though. You couldn't mention both the name of the drug and what it was for in an ad without including the entire warning label text. The deregulation was another Clinton thing, and its main beneficiary was the SSRIs.
    - azinman2 10y ago
      I believe that's still the case -- which is why we get all those commercials with happy people having family moments while a voice in the background quickly announces "if you have experience any of the following symptoms head to the ER immediately."
baddox 10y ago
Don't forget that lobbying budgets for pharmaceuticals are also huge. I'd rather pharmaceuticals spend money to show me ads while I still get to make my own choices than spend money to buy laws that restrict my choices.
paulryanrogers 10y ago
"Don't forget that marketing budgets for pharmaceuticals are also huge" Why is it advertising regulated drugs to uninformed consumers is legal?

zdean 10y ago

The issue with non-regulated dietary supplements may well be caused by the current state of regulation (this is strictly my own opinion/observation). In the current state of things, we've grown accustomed to seeing warnings when the government thinks there is a potential danger with a particular FDA regulated drug. So perhaps the lack of warnings with supplements is giving people a false sense of security about the dietary supplements...ie, "if they were dangerous, surely there'd be a warning". If, as the parent comment suggests, the paradigm shifts so that the government's position is one of several factors to consider, perhaps then people would look at supplements with a greater degree of caution and suspicion. In other words, changing the paradigm may change people's behavior in terms of how they approach both drugs and supplements.

spqr0a1 10y ago

Idiosyncratic Drug-induced Liver Injury (DILI) is only 13-20% of all DILI. The other ~80% being pharmacological. About 40% of all acute liver failure is caused by acetaminophen. http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.html http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.... Meaning a single FDA approved over-the-counter drug is responsible for over 20 times as much liver failure as all dietary supplements. Some regulation may be beneficial but the current policies are clearly suboptimal.

ejstronge 10y ago
Acetaminophen is a interesting example - it's a very (centuries) old drug that predates the regulatory framework we have today. Some scholars (see ref. 1 for some history) suggest that it would not be approved by today's FDA. It's thus a poor selection if one wishes to discredit the FDA's efficacy; indeed, some other widely-used therapeutics (e.g., aspirin) came into use before drug efficacy was required for new drug approval. At the same time, there are numerous examples of drugs either not approved by the FDA or withdrawn from the US market by the FDA. It's not clear how less regulation would achieve this type of nation-wide safety benefit. [1] http://s3.documentcloud.org/documents/793731/mcneil-history-by-students.pdf http://s3.documentcloud.org/documents/793731/mcneil-history-...

dcosson 10y ago

I've been thinking recently about government regulations like this and about where it should end. Why are we so sure that we can't trust people to make an educated decision about an experimental drug or any of the many other things we regulate, many of which only impact themselves and don't put the general public at risk in any way. Yet one of our most deeply held values is trusting them to make an educated decision about who should run the country. It's certainly not any less complex of a topic when you consider all of the policy areas that there are to evaluate politicians across.

baddox 10y ago

You didn't show any evidence of the FDA being a net benefit. You only showed that the FDA probably could have reduced that specific type of liver injury by regulating those specific supplements. But the government is not magic, and the FDA almost certainly has also caused injuries by overly or erroneously regulating other things. I have no idea what the net effect is, but you certainly haven't shown it to be positive.

ejstronge 10y ago
I'm curious about your assertion of 'overly' regulating things leading to a net negative effect. Are there specific examples you're considering?
- baddox 10y ago
  Marijuana would be the most obvious example.
  - ejstronge 10y ago
    Sorry to reply so late. I think we would do well to separate concerns about recreational drugs from the FDA's regulation of pharmaceuticals. I totally agree that our regulation of marijuana (when compared to similar substances like cigarettes) has been problematic. Are there examples of pharmaceuticals you were considering?
    - baddox 10y ago
      I meant medical marijuana.

oh_sigh 10y ago

What dietary supplements can cause liver injury?

ageofwant 10y ago
Vitamin A, typically. Or more generally fat-soluble vitamins. The label usually warns you.
- oh_sigh 10y ago
  Oh, duh. People don't know that? That's why I refuse to eat polar bear liver.

lend000 10y ago

And people will also choose to eat potato chips, not exercise, smoke, and drink heavily. You can't protect people from themselves, and even if it was an ethical government job to do so, i.e. take away people's freedoms because the government says it knows better, like with marijuana (I am REALLY humoring you, if you can't tell), there is no practical argument either. How much do you think your high estimate of X% who get sick by their own incompetence (which of course goes down significantly when people realize that they shouldn't blindly trust everything in our markets -- that blind, oft-misguided trust is another side effect of the FDA/USDA) will be DWARFED by the percentage of people saved by life saving drugs that make it to market faster/would otherwise be blocked. Do you know how many people the FDA has sentenced to die directly by rejecting appeals from terminally ill patients to get access to experimental drugs/procedures? Not to mention the indirect damage of delaying medicinal progress...

djsumdog 10y ago
True, there are always people who will do that. I try to eat very low-carb and it's helped my heath dramatically, but even I occasionally will have a burger or real pasta. The issue is education. It's very difficult to tell what is healthy and what isn't. There is a lot of research coming out that shows us sugar and starches are very bad for us. The stress from those carbs can damage our arteries and is what allows cholesterol to build. The industry has a vested interest in people not knowing/believing in that. Sugar and HF Corn Syrup is a massive industry. Soda companies have been losing money as people finally move away and now we start to see the tides change. Regardless, we need good education about what is and isn't health. Otherwise people struggle with weight and just get frustrated and resolve themselves to eat unhealthy because nothing seems to help reduce their weight or cravings.
- kyriakos 10y ago
  How's a burger carbs btw? Unless you mean the bun and not the actual patty.
  - kyriakos 10y ago

ageofwant 10y ago

These kind of context-less banding about of figures always serve the point the bander is trying to make, and rarely the truth. It leaves out the fact, for example, that regulated medicine is responsible for the rest. If we exclude approved regulated alcohol, the liver damage caused by unregulated 'medicine' is almost noise.

Veratyr 10y ago

> You have a theory that the average person will wisely assume the responsibility to vet the health effects of what they consume, but empirical reality disagrees with your theory. Right now people are injuring themselves with products at the margin of regulation. I know this is an incredibly callous opinion but isn't this natural selection at work? People even go further and knowingly partake of substances known to be harmful (cigarettes). We don't stop them from that, why should we stop them from consuming medication that hasn't yet been deemed safe? Educating and providing support for those that need it I agree with but if people freely and knowingly choose to act in a self destructive manner with a sound mind, I'm not convinced it benefits society or themselves to forcibly preserve their life.

darpa_escapee 10y ago
Isn't murder survival of the fittest? We as a society have decided that, generally, profiting from causing harm to others incentives bad things. I don't want cough medicine that might stop my breathing, but heroin was regularly sold as just that before the FDA. History has shown that without regulation the quality, efficacy, composition, safety and side-effect profile of drugs might stray from reality because of market incentives. The unfortunate truth is that sometimes it is more profitable if those five things are ignored and people get hurt or die. Hence, regulation. > People even go further and knowingly partake of substances known to be harmful (cigarettes). Tobacco products are heavily regulated. One could argue that because of lobbying and the amounts of wealth involved, that tobacco companies have been spared some of the stronger regulations they could have faced.
- Veratyr 10y ago
  > Isn't murder survival of the fittest? Murder is bad for society, as people who can benefit society through say their knowledge of medicine or physics aren't adept at self defence. A similar argument could be made that people who aren't very good at taking care of themselves are valuable to society somehow and should be protected from idiotic self-harm but I believe a person's autonomy trumps society's interest in preserving whatever value they have. > I don't want cough medicine that might stop my breathing, but heroin was regularly sold as just that before the FDA. Heroin was sold as cough medicine that might stop your breathing? If it tells you you might die and you choose to ingest it, that's on you. If you choose to play Russian Roulette, nobody's stopping you. In case it wasn't sold with a warning that it might stop your breathing, you could have chosen to verify that it did what you expected before ingesting it. The modern FDA could also warn of the dangers without forbidding the sale of the substance. > Tobacco products are heavily regulated. They may be regulated but any adult can still choose to partake of however much they like regardless of the damage to their health.

BurningFrog 10y ago

From your link: RESULTS: DILI was caused by a single prescription medication in 73% of the cases, by dietary supplements in 9%, and by multiple agents in 18%. More than 100 different agents were associated with DILI; antimicrobials (45.5%) and central nervous system agents (15%) were the most common. CONCLUSIONS: DILI is caused by a wide array of medications, herbal supplements, and dietary supplements. Antibiotics are the single largest class of agents that cause DILI. So FDA approved drugs cause 73% of these liver injuries, while unregulated supplements cause 9%. I don't understand how that is an argument for FDA regulation?