5 ms·

Can other countries conduct trials for these treatments at the patient's own risk?

2Gkashmiri 2y ago
i find this funny. what do you mean "patient's own risk?" that has always been the case. you go for a minor surgery, you sign a waiver. you go to a doctor, they are supposed to give reasonable care. No one can guarantee success. the same with lawyers or drivers or mechanics or technicians. basically anytime you go to someone for assistance, they can't guarantee anything. the person is themselves always responsible for everything.
- adastra22 2y ago
  With the FDA rules they are not legally allowed to offer such services, however.
  - dahart 2y ago
    Not sure what you’re talking about. In general the FDA does not regulate medical “services” or procedures.
- dahart 2y ago
  Of course there’s always some risk with any drug or medical procedure. But - obviously - not all risk is equal. Unapproved treatments are riskier because they haven’t been proven effective, and they haven’t been well tested for side effects. There is an uncountably large list of cases throughout history of people willing to sell ineffective and/or actively harmful treatments, which is the whole reason the FDA exists. Look up people who died taking ivermectin for Covid [1], or just pick any ailment and do some research on fake treatments, perhaps cancer for example [2]. The UN says half a million people in Africa alone are being killed every year by fake medicine today, currently [3]. [1] https://www.unmc.edu/healthsecurity/transmission/2023/03/14/an-ivermectin-influencer-died-now-his-followers-are-worried-about-their-own-severe-symptoms/ https://www.unmc.edu/healthsecurity/transmission/2023/03/14/... [2] https://en.wikipedia.org/wiki/List_of_unproven_and_disproven_cancer_treatments https://en.wikipedia.org/wiki/List_of_unproven_and_disproven... [3] https://www.un.org/africarenewal/magazine/february-2023/fake-medicines-kill-almost-500000-sub-saharan-africans-year-unodc-report-0 https://www.un.org/africarenewal/magazine/february-2023/fake...
  - adastra22 2y ago
    History is also full of examples of treatments that do work under unknown (at the time) circumstances and were standardized into common practice through trial and error. This includes most over the counter medication and procedures today. Most of that advancement stopped with the introduction of the FDA and its equivalents in other countries. The story of efficacy trials falls apart when you consider the complex reality of the human body and pharmaceutical action. There are many medical procedures and drugs which we know work on certain patients some of the time, but we are prevented from giving to new patients because the high standards of Phase III efficacy haven’t been met.
    - dahart 2y ago
      So what? The U.S. food and drug laws aren’t protecting against things that accidentally work, they are protecting against things that don’t work. These laws are hard won and represent many people lost to both ignorance and greed. If something has efficacy, then trials will eventually prove it, it’s just a matter of time. You just made a case that the process works. If efficacy can’t be shown, then it’s very risky for people to try the treatment, riskier than using something with known outcomes, and potentially riskier than doing nothing at all. Either way this is all irrelevant to your bogus claim at the top that the FDA has anything to do with the perception that treatments aren’t improving. The top comment’s hypothesis is incorrect, which adds to the multiple reasons your proposed explanation is wrong.
      - adastra22 2y ago
        Where did I make the case of process works? It doesn’t. there are hundreds of examples of promising medication that will never be approved because there is no money or will to do phase 3 trials. Often because those drugs fell out of patent protection during some normal, typical snag in the testing process.
        dahart 2y ago
        It doesn’t work? So no new medications are being approved? I suspect that’s not quite correct. ;) Is it possible the examples you’re thinking of simply don’t have enough backing because they’re either not effective, or they have serious side effects? What drugs specifically do you believe are being overlooked? It is true that regulating drugs and having an approval process causes new drugs to take time, causes some to be rejected, and that people who could use them don’t get them until approved. It is true that some people could die waiting for drugs to be approved that will be shown effective. I lost a friend this year to a cancer that had an experimental treatment that he wasn’t eligible for, and it’s incredibly frustrating. Yet this has been thoroughly debated for hundreds of years, and what we have is a system that is fairly effective at minimizing harm and maximizing effectiveness given the science we have at hand. Your argument so far has completely ignored: - The FDA’s Investigational Drug program. - The Right To Try Act, and all the preceding debate and legislation. - The fact that most new drugs developed are not effective and some have very serious consequences. - The fact that unscrupulous actors exist, and there are widespread and serious problem with fake medicines. You have nothing to say about the data I linked to on the distribution of fake drugs currently killing children by the hundreds of thousands??? If you can’t even acknowledge the basis on which the FDA was founded (regulating drugs was made a requirement by Congress) or the fact that they are balancing competing public health benefits, then your argument will get nowhere and is not being made in good faith. If you want to demonstrate why drugs should be unregulated and why we should suffer the harm that would cause, or make the case for relaxing the regulations more than the New Investgational Drug program allows and spell out how it would lead to more benefit than harm, I’m all ears! You might not be considering the possibility that relaxing drug testing and regulations could backfire and make it harder for effective drugs to reach the market. Maybe it’s worth researching the history of this debate a bit more? https://jnm.snmjournals.org/content/59/10/1492 https://jnm.snmjournals.org/content/59/10/1492
adastra22 2y ago
Trials? No. There are various other countries you can go to in order to have these unapproved treatments performed, at great personal cost because there are no economies of scale. But there largely aren't countries performing trials that would count as an FDA Phase II or Phase III trial.
- reverius42 2y ago
  > at great personal cost because there are no economies of scale I didn’t realize the USA was the only Economy of Scale
  - adastra22 2y ago
    I’m talking about treatments that aren’t approved anywhere.
    - reverius42 2y ago
      You specifically mentioned the FDA as being a problem; are you suggesting that approval in general is the problem, and no approval should be required anywhere?
      - adastra22 2y ago
        Yes.
        dahart 2y ago
        Those who cannot remember the past are condemned to repeat it.
  - NemoNobody 2y ago
    The US is the Primary economy of scale as it is the primary economy in general.

i find this funny. what do you mean "patient's own risk?" that has always been the case. you go for a minor surgery, you sign a waiver. you go to a doctor, they are supposed to give reasonable care. No one can guarantee success. the same with lawyers or drivers or mechanics or technicians. basically anytime you go to someone for assistance, they can't guarantee anything. the person is themselves always responsible for everything.

adastra22 2y ago
With the FDA rules they are not legally allowed to offer such services, however.
- dahart 2y ago
  Not sure what you’re talking about. In general the FDA does not regulate medical “services” or procedures.
dahart 2y ago
Of course there’s always some risk with any drug or medical procedure. But - obviously - not all risk is equal. Unapproved treatments are riskier because they haven’t been proven effective, and they haven’t been well tested for side effects. There is an uncountably large list of cases throughout history of people willing to sell ineffective and/or actively harmful treatments, which is the whole reason the FDA exists. Look up people who died taking ivermectin for Covid [1], or just pick any ailment and do some research on fake treatments, perhaps cancer for example [2]. The UN says half a million people in Africa alone are being killed every year by fake medicine today, currently [3]. [1] https://www.unmc.edu/healthsecurity/transmission/2023/03/14/an-ivermectin-influencer-died-now-his-followers-are-worried-about-their-own-severe-symptoms/ https://www.unmc.edu/healthsecurity/transmission/2023/03/14/... [2] https://en.wikipedia.org/wiki/List_of_unproven_and_disproven_cancer_treatments https://en.wikipedia.org/wiki/List_of_unproven_and_disproven... [3] https://www.un.org/africarenewal/magazine/february-2023/fake-medicines-kill-almost-500000-sub-saharan-africans-year-unodc-report-0 https://www.un.org/africarenewal/magazine/february-2023/fake...
- adastra22 2y ago
  History is also full of examples of treatments that do work under unknown (at the time) circumstances and were standardized into common practice through trial and error. This includes most over the counter medication and procedures today. Most of that advancement stopped with the introduction of the FDA and its equivalents in other countries. The story of efficacy trials falls apart when you consider the complex reality of the human body and pharmaceutical action. There are many medical procedures and drugs which we know work on certain patients some of the time, but we are prevented from giving to new patients because the high standards of Phase III efficacy haven’t been met.
  - dahart 2y ago
    So what? The U.S. food and drug laws aren’t protecting against things that accidentally work, they are protecting against things that don’t work. These laws are hard won and represent many people lost to both ignorance and greed. If something has efficacy, then trials will eventually prove it, it’s just a matter of time. You just made a case that the process works. If efficacy can’t be shown, then it’s very risky for people to try the treatment, riskier than using something with known outcomes, and potentially riskier than doing nothing at all. Either way this is all irrelevant to your bogus claim at the top that the FDA has anything to do with the perception that treatments aren’t improving. The top comment’s hypothesis is incorrect, which adds to the multiple reasons your proposed explanation is wrong.
    - adastra22 2y ago
      Where did I make the case of process works? It doesn’t. there are hundreds of examples of promising medication that will never be approved because there is no money or will to do phase 3 trials. Often because those drugs fell out of patent protection during some normal, typical snag in the testing process.
      - dahart 2y ago
        It doesn’t work? So no new medications are being approved? I suspect that’s not quite correct. ;) Is it possible the examples you’re thinking of simply don’t have enough backing because they’re either not effective, or they have serious side effects? What drugs specifically do you believe are being overlooked? It is true that regulating drugs and having an approval process causes new drugs to take time, causes some to be rejected, and that people who could use them don’t get them until approved. It is true that some people could die waiting for drugs to be approved that will be shown effective. I lost a friend this year to a cancer that had an experimental treatment that he wasn’t eligible for, and it’s incredibly frustrating. Yet this has been thoroughly debated for hundreds of years, and what we have is a system that is fairly effective at minimizing harm and maximizing effectiveness given the science we have at hand. Your argument so far has completely ignored: - The FDA’s Investigational Drug program. - The Right To Try Act, and all the preceding debate and legislation. - The fact that most new drugs developed are not effective and some have very serious consequences. - The fact that unscrupulous actors exist, and there are widespread and serious problem with fake medicines. You have nothing to say about the data I linked to on the distribution of fake drugs currently killing children by the hundreds of thousands??? If you can’t even acknowledge the basis on which the FDA was founded (regulating drugs was made a requirement by Congress) or the fact that they are balancing competing public health benefits, then your argument will get nowhere and is not being made in good faith. If you want to demonstrate why drugs should be unregulated and why we should suffer the harm that would cause, or make the case for relaxing the regulations more than the New Investgational Drug program allows and spell out how it would lead to more benefit than harm, I’m all ears! You might not be considering the possibility that relaxing drug testing and regulations could backfire and make it harder for effective drugs to reach the market. Maybe it’s worth researching the history of this debate a bit more? https://jnm.snmjournals.org/content/59/10/1492 https://jnm.snmjournals.org/content/59/10/1492

adastra22 2y ago

Trials? No. There are various other countries you can go to in order to have these unapproved treatments performed, at great personal cost because there are no economies of scale. But there largely aren't countries performing trials that would count as an FDA Phase II or Phase III trial.

reverius42 2y ago
> at great personal cost because there are no economies of scale I didn’t realize the USA was the only Economy of Scale
- adastra22 2y ago
  I’m talking about treatments that aren’t approved anywhere.
  - reverius42 2y ago
    You specifically mentioned the FDA as being a problem; are you suggesting that approval in general is the problem, and no approval should be required anywhere?
    - adastra22 2y ago
      Yes.
      - dahart 2y ago
        Those who cannot remember the past are condemned to repeat it.
- NemoNobody 2y ago
  The US is the Primary economy of scale as it is the primary economy in general.