6 ms·

70% of Phase 2 trials fail and 50% of Phase 3 trials fail[1]. Why should the default to be to approve drugs in the early stage of human experimentation? Here a

70% of Phase 2 trials fail and 50% of Phase 3 trials fail[1]. Why should the default to be to approve drugs in the early stage of human experimentation? Here are some interesting case studies of drugs graduating from Phase 2 trials only to fail Phase 3 trials on efficacy and safety grounds: https://www.fda.gov/media/102332/download https://www.fda.gov/media/102332/download [1] https://www.parexel.com/application/files_previous/5014/7274/5573/ACT_Article.pdf https://www.parexel.com/application/files_previous/5014/7274...

rzz3 4y ago
Because (at least) for people with a high risk of dying, and operating under well-informed consent, that decision should be between patients and their doctors alone.
- photonic31 4y ago
- sumedh 4y ago
  > Because (at least) for people with a high risk of dying and who decides that? Can a drug company give "gifts" to doctor who then recommend the patient use that company's drugs when he/she is dying?
- hp48fan 4y ago
  Because it would degenerate into pharmaceuticals selling false hope in exchange for lab rats that are too far along to be saved even if the drugs work. That being said I disagree with prescription pads. I should buy antibiotics for my kid without waiting four, five hours to be seen and processed
  - pastacacioepepe 4y ago
    > I should buy antibiotics for my kid without waiting four, five hours to be seen and processed Disagree. Antibiotics should not be taken lightly, especially by kids. Doctors have been far too liberal in prescribing them even when unnecessary and this has caused people to think antibiotics are to be taken like vitamins. This antibiotic abuse causes issues that are out of scope to discuss here.
    - hp48fan 4y ago
      Which is why I get annoyed when Dr. prescribe them more liberally than I would; for things that they'll admit are probably viral. But when a girl with a history of UTI is screaming in pain they come back with "Id rather wait for the cultures to come back" No. Bugger off and give me the meds. I know my kid. I know what she has. And the culture confirms it three days layer every time.
  - Wowfunhappy 4y ago
    The more we use antibiotics, the more opportunities there are for bacteria to evolve resistance.
    - hp48fan 4y ago
      So Ive been told. And yet the Dr gives them out in exactly the same circumstances as I would if I could. Perhaps more liberally, since Im far more concerned about the consequences to my kids of destroying their gut flora.
      - scoopertrooper 4y ago
        It seems like you want to create a general rule entirely based on your own personal experience.
        hp48fan 4y ago
        You are correct. I arrive at conclusions based on my life experiences and what I've learned along the way. We literally give industrial quantities of antibiotics to animals. So antibiotic preservation is not an honest reason to lock them up Tylenol and Advil can very quickly mess up your kid's liver and kidneys if you misdose. Yet, they're over the counter. So safety does not appear to be an honest reason either. Ironically, statistically considering the forum, most ppl who are against me on this thread believe in drug liberalization including opiates; the one class for drugs I would keep behind the pharmacist's counter. Btw, antibiotics are available over the counter in Europe. The ones Id use and feel comfortable using
        Wowfunhappy 4y ago
        > We literally give industrial quantities of antibiotics to animals. So antibiotic preservation is not an honest reason to lock them up We desperately need to stop doing that too, but at least it optimizes for bacteria that infects animals rather than humans. I don't think you (and most other people) are anywhere near scared enough of returning to a world without antibiotics.
- scoopertrooper 4y ago
  There's definitely a case to be made for early access to drugs for certain terminal illnesses in cases where there is compelling evidence that the drugs will pass Phase 3 trials. But, that should hardly be the 'default' as OP suggests.
- snowwrestler 4y ago
  Such patients have opportunities to access experimental drugs, either in clinical trials, or through compassionate use waivers. https://www.cancer.gov/about-cancer/treatment/drugs/access-experimental https://www.cancer.gov/about-cancer/treatment/drugs/access-e...
- isitmadeofglass 4y ago
  If we allowed any type of experimentation on dying patients as long as there was consent, dying patients would end up getting used as a Guineapigs by companies trying to get a lucky indication. It would certainly benefit the families left behind financially, but it would not be pretty. “Here’s a million bucks, please take these 40 drugs that will certainly kill you, but we’ll learn which one we should continue with”. And why even do toxicity studies or phase 1 and 2 trials? It’s cheaper to pay of poor people who are on the verge of dying and just pushing them over the edge. The decision should be just because a patient and a doctor, because the consequences of such decisions are more far reaching than just those two. We have a well established framework for what a drug needs to prove before they can reasonable be allowed to be given to any human being, no matter their situation, and that barrier of entry is there for a multitude of good reasons. Discarding it just because a specific patient is at risk of dying or because you can get consent is not helping patients.
  - tim333 4y ago
    If I was dying I'd rather be able to make a choice to my benefit rather than worrying about that it'd "be pretty" for onlookers.
    - evandijk70 4y ago
      You might be able to make an informed decision. Most people (and most doctors, for that matter), are not qualified to accurately judge the many uncertainties, biases and trade-offs present in drugs only tested in early stage clinical trials.
      - isitmadeofglass 4y ago
        And to add on top of that. If pharmaceuticals could buy out dying patients at a fraction of a cost of even the pre clinical trials to get first human dose there would no longer be such a thing as “early stage clinical trials”
    - isitmadeofglass 4y ago
      There are certain choices we as a society do not want to allow you to make even if both you and the other party concents. Just because your dying and for instance would be ok with being hunted for sport in a Netflix special in return for a million dollar payout to your family does not mean we should forgoe all morals, logic and law and just accept it. Allowing dying patients to make those sorts of deals with pharmaceuticals is just as horrible in the grander scale of things, they just stand to save a lot more costs and gain a lot more profits than Netflix would in a “Running Man” scenario.
BurningFrog 4y ago
After Phase 2, the drug has been proven safe. In a sane and humane system, sick people would then be allowed to try it.
- josho 4y ago
  Pharma would market a phase 2 trial drug as a “potential revolution in treatment. Only a select few can receive this treatment and as a result it costs 10x more than existing drugs. Ps. We don’t guarantee results.” Is that really the outcome you want?
  - BurningFrog 4y ago
    What I want is fewer people to die while waiting for the FDA to take years to approve already existing drugs. You seem to care more about marketing than people's lives. We all have different priorities.
    - deleted 4y ago
      [deleted]
    - kradeelav 4y ago
      (Not the OP) In a macro sense, I'd agree with you; no stranger to having to weigh the risks/rewards of experimental drugs. But at the same time, I do get why extensive approval is needed - deaths can and often do occur from allergic reactions and/or side effects to medicines, and the idea is to hopefully lower the ratio of that happening. At some point more people "will" die from allergic reactions/side effects than the time it takes to get approval.
      - BurningFrog 4y ago
        What people usually miss is the cost in lives of delays in approving or developing cures: https://marginalrevolution.com/marginalrevolution/2021/01/the-invisible-graveyard-is-invisible-no-more.html https://marginalrevolution.com/marginalrevolution/2021/01/th...
stjohnswarts 4y ago
I mean if they've already tried everything else and nothing on the horizon and I just heard 12 of 12 people with same cancer as me had gone into remission after treatment? I'd probably be more than happy to become #13

rzz3 4y ago

Because (at least) for people with a high risk of dying, and operating under well-informed consent, that decision should be between patients and their doctors alone.

photonic31 4y ago
sumedh 4y ago
> Because (at least) for people with a high risk of dying and who decides that? Can a drug company give "gifts" to doctor who then recommend the patient use that company's drugs when he/she is dying?
hp48fan 4y ago
Because it would degenerate into pharmaceuticals selling false hope in exchange for lab rats that are too far along to be saved even if the drugs work. That being said I disagree with prescription pads. I should buy antibiotics for my kid without waiting four, five hours to be seen and processed
- pastacacioepepe 4y ago
  > I should buy antibiotics for my kid without waiting four, five hours to be seen and processed Disagree. Antibiotics should not be taken lightly, especially by kids. Doctors have been far too liberal in prescribing them even when unnecessary and this has caused people to think antibiotics are to be taken like vitamins. This antibiotic abuse causes issues that are out of scope to discuss here.
  - hp48fan 4y ago
    Which is why I get annoyed when Dr. prescribe them more liberally than I would; for things that they'll admit are probably viral. But when a girl with a history of UTI is screaming in pain they come back with "Id rather wait for the cultures to come back" No. Bugger off and give me the meds. I know my kid. I know what she has. And the culture confirms it three days layer every time.
- Wowfunhappy 4y ago
  The more we use antibiotics, the more opportunities there are for bacteria to evolve resistance.
  - hp48fan 4y ago
    So Ive been told. And yet the Dr gives them out in exactly the same circumstances as I would if I could. Perhaps more liberally, since Im far more concerned about the consequences to my kids of destroying their gut flora.
    - scoopertrooper 4y ago
      It seems like you want to create a general rule entirely based on your own personal experience.
      - hp48fan 4y ago
        You are correct. I arrive at conclusions based on my life experiences and what I've learned along the way. We literally give industrial quantities of antibiotics to animals. So antibiotic preservation is not an honest reason to lock them up Tylenol and Advil can very quickly mess up your kid's liver and kidneys if you misdose. Yet, they're over the counter. So safety does not appear to be an honest reason either. Ironically, statistically considering the forum, most ppl who are against me on this thread believe in drug liberalization including opiates; the one class for drugs I would keep behind the pharmacist's counter. Btw, antibiotics are available over the counter in Europe. The ones Id use and feel comfortable using
        Wowfunhappy 4y ago
        > We literally give industrial quantities of antibiotics to animals. So antibiotic preservation is not an honest reason to lock them up We desperately need to stop doing that too, but at least it optimizes for bacteria that infects animals rather than humans. I don't think you (and most other people) are anywhere near scared enough of returning to a world without antibiotics.
scoopertrooper 4y ago
There's definitely a case to be made for early access to drugs for certain terminal illnesses in cases where there is compelling evidence that the drugs will pass Phase 3 trials. But, that should hardly be the 'default' as OP suggests.
snowwrestler 4y ago
Such patients have opportunities to access experimental drugs, either in clinical trials, or through compassionate use waivers. https://www.cancer.gov/about-cancer/treatment/drugs/access-experimental https://www.cancer.gov/about-cancer/treatment/drugs/access-e...
isitmadeofglass 4y ago
If we allowed any type of experimentation on dying patients as long as there was consent, dying patients would end up getting used as a Guineapigs by companies trying to get a lucky indication. It would certainly benefit the families left behind financially, but it would not be pretty. “Here’s a million bucks, please take these 40 drugs that will certainly kill you, but we’ll learn which one we should continue with”. And why even do toxicity studies or phase 1 and 2 trials? It’s cheaper to pay of poor people who are on the verge of dying and just pushing them over the edge. The decision should be just because a patient and a doctor, because the consequences of such decisions are more far reaching than just those two. We have a well established framework for what a drug needs to prove before they can reasonable be allowed to be given to any human being, no matter their situation, and that barrier of entry is there for a multitude of good reasons. Discarding it just because a specific patient is at risk of dying or because you can get consent is not helping patients.
- tim333 4y ago
  If I was dying I'd rather be able to make a choice to my benefit rather than worrying about that it'd "be pretty" for onlookers.
  - evandijk70 4y ago
    You might be able to make an informed decision. Most people (and most doctors, for that matter), are not qualified to accurately judge the many uncertainties, biases and trade-offs present in drugs only tested in early stage clinical trials.
    - isitmadeofglass 4y ago
      And to add on top of that. If pharmaceuticals could buy out dying patients at a fraction of a cost of even the pre clinical trials to get first human dose there would no longer be such a thing as “early stage clinical trials”
  - isitmadeofglass 4y ago
    There are certain choices we as a society do not want to allow you to make even if both you and the other party concents. Just because your dying and for instance would be ok with being hunted for sport in a Netflix special in return for a million dollar payout to your family does not mean we should forgoe all morals, logic and law and just accept it. Allowing dying patients to make those sorts of deals with pharmaceuticals is just as horrible in the grander scale of things, they just stand to save a lot more costs and gain a lot more profits than Netflix would in a “Running Man” scenario.

BurningFrog 4y ago

After Phase 2, the drug has been proven safe. In a sane and humane system, sick people would then be allowed to try it.

josho 4y ago
Pharma would market a phase 2 trial drug as a “potential revolution in treatment. Only a select few can receive this treatment and as a result it costs 10x more than existing drugs. Ps. We don’t guarantee results.” Is that really the outcome you want?
- BurningFrog 4y ago
  What I want is fewer people to die while waiting for the FDA to take years to approve already existing drugs. You seem to care more about marketing than people's lives. We all have different priorities.
  - deleted 4y ago
    [deleted]
  - kradeelav 4y ago
    (Not the OP) In a macro sense, I'd agree with you; no stranger to having to weigh the risks/rewards of experimental drugs. But at the same time, I do get why extensive approval is needed - deaths can and often do occur from allergic reactions and/or side effects to medicines, and the idea is to hopefully lower the ratio of that happening. At some point more people "will" die from allergic reactions/side effects than the time it takes to get approval.
    - BurningFrog 4y ago
      What people usually miss is the cost in lives of delays in approving or developing cures: https://marginalrevolution.com/marginalrevolution/2021/01/the-invisible-graveyard-is-invisible-no-more.html https://marginalrevolution.com/marginalrevolution/2021/01/th...

stjohnswarts 4y ago

I mean if they've already tried everything else and nothing on the horizon and I just heard 12 of 12 people with same cancer as me had gone into remission after treatment? I'd probably be more than happy to become #13