5 ms·

Isn't the answer simply: My body my choice?

by 908B64B197 3y ago

krick 3y ago
It should be. It isn't. The usual situation.
- asdfman123 3y ago
  One complexity is that patients might not be in a good place to evaluate whether a drug is truly viable or it's what they actually want, and they might face pressure from doctors or drug companies. But I generally agree that it should be the patient's choice.
  - zhivota 3y ago
    Right, also the state has a vested interest here, because patients bankrupting themselves on snake oil will result in more public money being spent on treatment.
  - Spivak 3y ago
    We already have a process for this called informed consent. * Medication must be prescribed by and supervised by an MD. * Doctor has to give you paperwork explaining everything about the drug, that it's not approved and experimental, what the known side effects are and personally go through it with you allowing you to ask questions. It's not currently required but you could also mandate a short cooling off period to avoid rash decisions. In an odd twist of fate the political faction that would love to eliminate the FDA also wants to eliminate informed consent because people are getting medical care they don't approve of. How dare the FDA tell you what you can and can't do with your body -- only we should be allowed to do that lololol
bequanna 3y ago
Right, but consider that this is a group of people that is vulnerable and desperate. They are ripe for being taken advantage of.
- pixl97 3y ago
  Hold up, you're forgetting the whole libertarian model... "My body, my choice, except when you take advantage of me and then I turn the full strength of the taxpayer funded law enforcement apparatus against you"
paxys 3y ago
Do you agree with the existence of the FDA at all then? Their entire job is to tell you what you can or cannot put in your body.
- JimtheCoder 3y ago
  "Their entire job is to tell you what you can or cannot put in your body." Isn't their job to tell businesses what they can or cannot sell to you to put in your body? Sorta different...
  - paxys 3y ago
    And in this case they are telling a drug company that they cannot sell an unapproved drug. Are you okay with that?
    - JimtheCoder 3y ago
      I'm not a fan of the FDA at all and the current clinical trial process. I was just commenting that I thought your statement as to what their responsibility was is incorrect.
    - hanniabu 3y ago
      Offer it for free, problem solved
      - JimtheCoder 3y ago
        How many pages would that legal liability waiver have to be...
- randyrand 3y ago
  I thought it was primarily to ensure standardized testing, labeling, etc.
- derefr 3y ago
  Technically, the FDA regulates precisely one thing: labelling. They regulate what can be marketed as a name with a conventional meaning ("cheese" or "beef") or what claims can be made about a product in its marketing ("treats headaches", etc.) The FDA audit for adulteration because e.g. "beef with high levels of thyroid hormone in it" isn't what people expect to be getting if they buy something called "beef." If you label the product as "beef with high levels of thyroid hormone in it", then it's fine! (Same reason "Cheez Whiz" isn't legally able to market itself as "cheese" — it doesn't contain what people expect "cheese" to conventionally contain.) The FDA audit for drug safety and efficacy because you can't say "makes your headache go away" if it actually doesn't; and you can't leave out "causes cancer in 1/10th of people who take it" if it does. (And for a novel substance, you can't know what claims you're able to make or leave out, without first doing a trial; so any claims you make are considered invalid by default without such a trial.) If you don't make any claims, you don't have to prove safety or efficacy. Supplements are just drugs that don't make any claims. This is also why there are products on the market that contain the active ingredients of prescription-only drugs, but are freely purchasable — these aren't marketed as being for human consumption. (GBL, a recreational drug related to GHB, is sold on the open market as a "brake-drum cleaning fluid." And it actually does work as a brake-drum cleaning fluid, so it's not like the FDA can challenge that.) If you're wondering about making drugs illegal: the FDA doesn't (and can't) do that. The DEA does that. If you're wondering about making drugs "controlled substances": Congress does that. Then the DEA and the FDA both enforce those rules — the DEA by preventing importation; and the FDA by preventing drugs from being marketed for sale that contain that active ingredient — basically treating it as an adulterant regardless of labelling. (Note that these are both commercial trade activities that are being restricted. Any chemical, no matter its controlled status, can be created, possessed, handled, and consumed within the confines of a secure facility — "secure" meaning that the facility takes measures to ensure that the substances won't leave the premises. This is how e.g. MDMA trials are able to continue at some universities, despite MDMA being a controlled substance.) If you're wondering about making drugs prescription-only: the FDA does determine this, but only kinda. More like, the Act of Congress that defines the FDA into existence, also defines the rules for whether a drug should be prescription-only. Drug companies are aware of the rules, and so they usually just make the drug prescription-only when it should be. The FDA is charged with catching violations, where a drug that should be prescription-only was marketed OTC. (What is the rule itself? It basically boils down to "if the necessary claims made by the drug are arcane and/or subtle enough, that a non-medically-trained lay-person couldn't reasonably be expected to evaluate their own safety in taking the drug, without a medical professional to act as an interpreter — then lay-people should only be able to access the drug through a scrip from such a qualified medical interpreter." It's still fundamentally about claims and labelling!)
ilc 3y ago
If you have good information, and your facilities to make a good decision... yes. Alas, the FDA and friends exist for a reason. Snake Oil, or even things that are downright harmful are out there, that people will sell as cures, or great things. To strawman: People say all natural is great. I remind them hemlock is all natural, but you probably don't want to digest it.
- ChainOfFools 3y ago
  cancer is all natural too, as are influenza and literally every biological pathogen.
- Spivak 3y ago
  And if the FDA played an advisory role certifying products but not outlawing unapproved goods and informed consent was required for an MD to dispense unapproved drugs I really don't see how we're worse off.
  - fzeroracer 3y ago
    > informed consent was required for an MD to dispense unapproved drugs How do you define this, exactly? A family member gets wind of this radical new treatment for their terminal cancer, let's call it HemWick. They talk to their doctor and say they really want to take it, so they have no choice but to sign off on it. They spend $50,000 on a four week regiment and by week two they're feeling a lot better and week four they're dead. Now you're probably thinking 'Hemlock is obviously poisonous', except the reason why these regulations exist is because people were selling literal poison as cures for diseases and profiting immensely.
    - Spivak 3y ago
      Sure, but that's the informed part of informed consent. Before you can start a treatment like this you have to have all the risks and benefits spelled out for you plainly by a real medical professional. Informed consent doesn't mean no rules at all and you regulate the messaging. "This drug is known to be poisonous and at the prescribed dosage it would be lethal. There is no no success of this drug treating any disease including cancer." I can't imagine anyone signing up after that.
Jun8 3y ago
Very interesting question, touched on famously in The Hitchiker’s Guide (https://hitchhikers.fandom.com/wiki/Ameglian_Major_Cow https://hitchhikers.fandom.com/wiki/Ameglian_Major_Cow). Some thoughts to consider: * the person giving consent may not be fully aware of consequence or may not have the faculties to make an informed decision * even if they are, they may be forced by circumstances, eg. a father selling his kidney for his son’s education * even if the above two are satisfied, the act may be morally deplorable to (parts of) society, eg. https://en.m.wikipedia.org/wiki/The_Ones_Who_Walk_Away_from_Omelas https://en.m.wikipedia.org/wiki/The_Ones_Who_Walk_Away_from_... (however, note that society is generally Ok with bodily sacrifice in wars)
- hinkley 3y ago
  The negative consequences of their choices impact all their loved ones or everyone in their social circle. Also if you work in the hospital you may have to deal with some very disturbing shit if things go badly. People don’t just turn into smoke when they die, and anyone who lived through the Pandemic should remember what a horror show a not dead patient can be. I had a running argument with a friend who was terrible at money management who got very grumpy when anyone addressed the issue of money. It was his choice and none of our business. Except group activities are affected by one party being broke all the time and bringing up money problems. People who care about you are affected by your decisions. You getting defensive about it is all about you, not us. See also our friend with health problems who would stay up late the night before or not eat well/prepare for an event and result in us having to manage them or bail out in the middle. That gets old really fuckin quickly.
Zigurd 3y ago
No. For the simple reason that there are both legitimate investigative drugs and treatments, and there are quacks and hucksters preying on the desperate. Your body is not your choice when it gives quacks publicity, never mind revenue, to victimize others and spread disinformation. There is a lot to be dissatisfied with re conventional pharma and medical practice. But opening the door to cranks is not an improvement. You might be asking "How can you tell which is which?" One of these has publications, has trials planned, etc. The other has the usual signs of quackery.
civilitty 3y ago
Your body, your cutting edge personal pharmaceutical manufacturing facility - then yes, your choice. The FDA regulates the manufacturing and distribution of the drugs, not what you put in your body.
nitwit005 3y ago
The problem tends to be the giant army of people and businesses that will happily lie to people about medical treatments. People believe the lies, get ill or die, and the swindlers walk away richer. There's a long, sad history of it. If you do have a terminal illness though, the government agrees with your premise: https://research.uci.edu/human-research-protections/clinical-research/drugs-and-biologics-used-in-clinical-research/right-to-try-drugs-biologics/ https://research.uci.edu/human-research-protections/clinical...
P_I_Staker 3y ago
No. You don't get to decide the medications you get put on. This is a human and civil rights catastrophe.

Isn't the answer simply: My body my choice?

krick 3y ago

It should be. It isn't. The usual situation.

asdfman123 3y ago
One complexity is that patients might not be in a good place to evaluate whether a drug is truly viable or it's what they actually want, and they might face pressure from doctors or drug companies. But I generally agree that it should be the patient's choice.
- zhivota 3y ago
  Right, also the state has a vested interest here, because patients bankrupting themselves on snake oil will result in more public money being spent on treatment.
- Spivak 3y ago
  We already have a process for this called informed consent. * Medication must be prescribed by and supervised by an MD. * Doctor has to give you paperwork explaining everything about the drug, that it's not approved and experimental, what the known side effects are and personally go through it with you allowing you to ask questions. It's not currently required but you could also mandate a short cooling off period to avoid rash decisions. In an odd twist of fate the political faction that would love to eliminate the FDA also wants to eliminate informed consent because people are getting medical care they don't approve of. How dare the FDA tell you what you can and can't do with your body -- only we should be allowed to do that lololol

bequanna 3y ago

Right, but consider that this is a group of people that is vulnerable and desperate. They are ripe for being taken advantage of.

pixl97 3y ago
Hold up, you're forgetting the whole libertarian model... "My body, my choice, except when you take advantage of me and then I turn the full strength of the taxpayer funded law enforcement apparatus against you"

paxys 3y ago

Do you agree with the existence of the FDA at all then? Their entire job is to tell you what you can or cannot put in your body.

JimtheCoder 3y ago
"Their entire job is to tell you what you can or cannot put in your body." Isn't their job to tell businesses what they can or cannot sell to you to put in your body? Sorta different...
- paxys 3y ago
  And in this case they are telling a drug company that they cannot sell an unapproved drug. Are you okay with that?
  - JimtheCoder 3y ago
    I'm not a fan of the FDA at all and the current clinical trial process. I was just commenting that I thought your statement as to what their responsibility was is incorrect.
  - hanniabu 3y ago
    Offer it for free, problem solved
    - JimtheCoder 3y ago
      How many pages would that legal liability waiver have to be...
randyrand 3y ago
I thought it was primarily to ensure standardized testing, labeling, etc.
derefr 3y ago
Technically, the FDA regulates precisely one thing: labelling. They regulate what can be marketed as a name with a conventional meaning ("cheese" or "beef") or what claims can be made about a product in its marketing ("treats headaches", etc.) The FDA audit for adulteration because e.g. "beef with high levels of thyroid hormone in it" isn't what people expect to be getting if they buy something called "beef." If you label the product as "beef with high levels of thyroid hormone in it", then it's fine! (Same reason "Cheez Whiz" isn't legally able to market itself as "cheese" — it doesn't contain what people expect "cheese" to conventionally contain.) The FDA audit for drug safety and efficacy because you can't say "makes your headache go away" if it actually doesn't; and you can't leave out "causes cancer in 1/10th of people who take it" if it does. (And for a novel substance, you can't know what claims you're able to make or leave out, without first doing a trial; so any claims you make are considered invalid by default without such a trial.) If you don't make any claims, you don't have to prove safety or efficacy. Supplements are just drugs that don't make any claims. This is also why there are products on the market that contain the active ingredients of prescription-only drugs, but are freely purchasable — these aren't marketed as being for human consumption. (GBL, a recreational drug related to GHB, is sold on the open market as a "brake-drum cleaning fluid." And it actually does work as a brake-drum cleaning fluid, so it's not like the FDA can challenge that.) If you're wondering about making drugs illegal: the FDA doesn't (and can't) do that. The DEA does that. If you're wondering about making drugs "controlled substances": Congress does that. Then the DEA and the FDA both enforce those rules — the DEA by preventing importation; and the FDA by preventing drugs from being marketed for sale that contain that active ingredient — basically treating it as an adulterant regardless of labelling. (Note that these are both commercial trade activities that are being restricted. Any chemical, no matter its controlled status, can be created, possessed, handled, and consumed within the confines of a secure facility — "secure" meaning that the facility takes measures to ensure that the substances won't leave the premises. This is how e.g. MDMA trials are able to continue at some universities, despite MDMA being a controlled substance.) If you're wondering about making drugs prescription-only: the FDA does determine this, but only kinda. More like, the Act of Congress that defines the FDA into existence, also defines the rules for whether a drug should be prescription-only. Drug companies are aware of the rules, and so they usually just make the drug prescription-only when it should be. The FDA is charged with catching violations, where a drug that should be prescription-only was marketed OTC. (What is the rule itself? It basically boils down to "if the necessary claims made by the drug are arcane and/or subtle enough, that a non-medically-trained lay-person couldn't reasonably be expected to evaluate their own safety in taking the drug, without a medical professional to act as an interpreter — then lay-people should only be able to access the drug through a scrip from such a qualified medical interpreter." It's still fundamentally about claims and labelling!)

ilc 3y ago

If you have good information, and your facilities to make a good decision... yes. Alas, the FDA and friends exist for a reason. Snake Oil, or even things that are downright harmful are out there, that people will sell as cures, or great things. To strawman: People say all natural is great. I remind them hemlock is all natural, but you probably don't want to digest it.

ChainOfFools 3y ago
cancer is all natural too, as are influenza and literally every biological pathogen.
Spivak 3y ago
And if the FDA played an advisory role certifying products but not outlawing unapproved goods and informed consent was required for an MD to dispense unapproved drugs I really don't see how we're worse off.
- fzeroracer 3y ago
  > informed consent was required for an MD to dispense unapproved drugs How do you define this, exactly? A family member gets wind of this radical new treatment for their terminal cancer, let's call it HemWick. They talk to their doctor and say they really want to take it, so they have no choice but to sign off on it. They spend $50,000 on a four week regiment and by week two they're feeling a lot better and week four they're dead. Now you're probably thinking 'Hemlock is obviously poisonous', except the reason why these regulations exist is because people were selling literal poison as cures for diseases and profiting immensely.
  - Spivak 3y ago
    Sure, but that's the informed part of informed consent. Before you can start a treatment like this you have to have all the risks and benefits spelled out for you plainly by a real medical professional. Informed consent doesn't mean no rules at all and you regulate the messaging. "This drug is known to be poisonous and at the prescribed dosage it would be lethal. There is no no success of this drug treating any disease including cancer." I can't imagine anyone signing up after that.

Jun8 3y ago

Very interesting question, touched on famously in The Hitchiker’s Guide (https://hitchhikers.fandom.com/wiki/Ameglian_Major_Cow https://hitchhikers.fandom.com/wiki/Ameglian_Major_Cow). Some thoughts to consider: * the person giving consent may not be fully aware of consequence or may not have the faculties to make an informed decision * even if they are, they may be forced by circumstances, eg. a father selling his kidney for his son’s education * even if the above two are satisfied, the act may be morally deplorable to (parts of) society, eg. https://en.m.wikipedia.org/wiki/The_Ones_Who_Walk_Away_from_Omelas https://en.m.wikipedia.org/wiki/The_Ones_Who_Walk_Away_from_... (however, note that society is generally Ok with bodily sacrifice in wars)

hinkley 3y ago
The negative consequences of their choices impact all their loved ones or everyone in their social circle. Also if you work in the hospital you may have to deal with some very disturbing shit if things go badly. People don’t just turn into smoke when they die, and anyone who lived through the Pandemic should remember what a horror show a not dead patient can be. I had a running argument with a friend who was terrible at money management who got very grumpy when anyone addressed the issue of money. It was his choice and none of our business. Except group activities are affected by one party being broke all the time and bringing up money problems. People who care about you are affected by your decisions. You getting defensive about it is all about you, not us. See also our friend with health problems who would stay up late the night before or not eat well/prepare for an event and result in us having to manage them or bail out in the middle. That gets old really fuckin quickly.

Zigurd 3y ago

No. For the simple reason that there are both legitimate investigative drugs and treatments, and there are quacks and hucksters preying on the desperate. Your body is not your choice when it gives quacks publicity, never mind revenue, to victimize others and spread disinformation. There is a lot to be dissatisfied with re conventional pharma and medical practice. But opening the door to cranks is not an improvement. You might be asking "How can you tell which is which?" One of these has publications, has trials planned, etc. The other has the usual signs of quackery.

civilitty 3y ago

Your body, your cutting edge personal pharmaceutical manufacturing facility - then yes, your choice. The FDA regulates the manufacturing and distribution of the drugs, not what you put in your body.

nitwit005 3y ago

The problem tends to be the giant army of people and businesses that will happily lie to people about medical treatments. People believe the lies, get ill or die, and the swindlers walk away richer. There's a long, sad history of it. If you do have a terminal illness though, the government agrees with your premise: https://research.uci.edu/human-research-protections/clinical-research/drugs-and-biologics-used-in-clinical-research/right-to-try-drugs-biologics/ https://research.uci.edu/human-research-protections/clinical...

P_I_Staker 3y ago

No. You don't get to decide the medications you get put on. This is a human and civil rights catastrophe.