4 ms·

Why is it that so many people need to die in the name of safety?

by px43 2y ago

pompino 2y ago
Because you can't honestly presume to know the outcome of a clinical trial of an untested product.
- FeepingCreature 2y ago
  So run the clinical trial, advertise the product as untested and dangerous-to-lethal in the meantime, and let people make their own choices?
  - bartekrutkowski 2y ago
    Smoking is already advertised as dangerous-to-lethal and look how effective it is in preventing people from smoking. In huge oversimplification some crazy or fraudulent people will claim it cures blindness or cold sores, some other people will believe them and will have to deal with the real danger-to-lethal consequences, with the rest of society paying for their medical care afterwards.
    - defrost 2y ago
      > Smoking is already advertised as dangerous-to-lethal and look how effective it is in preventing people from smoking. Pretty effective. In Australia throwing a few diseased lungs on the packs and increasing public awareness has seen usage drop from 35% of the population in 1980 to 11% today. Not all the drop is purely related to advertising, price increases and restricting sale to out of sight locked access in shops have also helped. https://www.tobaccoinaustralia.org.au/chapter-1-prevalence/1-3-prevalence-of-smoking-adults https://www.tobaccoinaustralia.org.au/chapter-1-prevalence/1...
      - mewpmewp2 2y ago
        From another perspective it took massive change in generations and over 40 years of campaigning and it is still a problem for the 11 percent.
        defrost 2y ago
        Knocking back smoking by two thirds has saved billions for the national health system. On the books, totally worth it.
        mewpmewp2 2y ago
        Sure, but imagine doing the same effort that likely requires critical mass for actual adaption on small obscure medicines and illnesses.
        FeepingCreature 2y ago
        Are they addictive? Then regulate them as addictive drugs. Are they not addictive? Then it seems a stretch to compare them to cigarettes.
        b800h 2y ago
        And cost billions in state pensions. I'm not suggesting that's any sort of counterargument but the costs should possibly be offset against other types of end-of-life care.
        defrost 2y ago
        It's been discussed. The balance has so far fallen on the side of anti smoking policy. Australia is a democracy with many small parties and several quasi independant larger party (three main large parties) members, there's been scope for almost anyone to campaign to repeal anti-smoking policy by either running directly or by lobbying their local of federal rep. People have campaigned for hunting, for cannabis, for many things .. so far no one, to my knowledge, has campaigned to repeal the anti smoking policies.
  - jddj 2y ago
    I have a new drug. It's called aceite deserpiente. It's a cure for lyme disease, impotence, ALS, chronic fatigue, cancer and aging. Trials are pending but what are you waiting for, do you want to die for lack of trying? 10k/dose.
    - ben_w 2y ago
      > aceite deserpiente Nice name choice for your example; I was thinking of paracetamoxyfrusebendroneomycin myself, yours is better.
    - FeepingCreature 2y ago
      See, the thing is, I can just choose not to buy it.
      - ben_w 2y ago
        Would you know not to? My mum bought into a lot of homeopathy and Bach flower remedies. Thought she was doing me and dad a favour by getting both, and even "secretly" gave dad doses of the latter (and I was a kid so didn't have much say), so I was fortunate both categories were basically nothing. But her and dad? One of the Bach flower remedies was "for memory"… she got Alzheimer's about 20 years younger than her mother. When my dad was dying of cancer, there was some mineral he thought he was short of (magnesium?), and he didn't realise the homeopathic pills labelled "magnesium" didn't actually contain any magnesium.
        FeepingCreature 2y ago
        Sure, but look at homeopathy. It's like a virus - you don't optimize for killing the user, because a dead user can't buy more meds, and also you might get sued. Instead you optimize for having as purely placebo an effect as you can. (It's also cheaper.) For that reason, I suspect the scam market is already saturated. Will some people get scammed into taking dangerous chemicals? Sure, but that's already the case cause those aren't regulated as medications. IMO, prevent use of addictive ingredients, but beyond that inform, don't forbid.
  - evandijk70 2y ago
    This already happens, it's called 'compassionate use' https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compassionate-use https://www.ema.europa.eu/en/human-regulatory-overview/resea...
- hackerlight 2y ago
  You've proposed a nonsensical epistemic framework. Knowing isn't binary. You should have a probability distribution over possibilities, based on your experience with similar drugs, expert hunches and animal trials. You then use that to estimate risks and benefits. Then compare this risk-reward profile with the risks of doing nothing -- in this case, near certain death from brain cancer. This "can't presume to know" framework is just sophistry. And I think deep down you know that, if you had a death sentence from brain cancer you'd be begging them to let you in the trial even if they "couldn't presume to know".
  - pompino 2y ago
    Maybe the person calling the FDA "nonsensical" should be someone who has actually researched, manufactured, and sold a pharmaceutical product, not some rando on HN. People who dismiss patient safety cannot be taken seriously in my worldview - which thankfully every developed country's regulatory body shares.
  - haldujai 2y ago
    You’re missing that we have treatments with known risk/benefits vs research treatment X with undefined risk and reward. It’s extremely challenging if not impossible to obtain informed consent in this situation. We’ve been through this before where a fancy new treatment with promising early/lab results usurped conventional therapy only to later be found inferior. Earlier TKIs and NSCLC are a recent example that comes to mind.
    - hackerlight 2y ago
      It's not undefined, though. That's the point I'm getting at. There is no binary of known and unknown. A tentative picture exists based on animal trials and expert judgment. That tentative picture informs an estimation of the risk to reward profile which is then the basis for an informed decision. This is decision making under uncertainty. It's bad practice to say that uncertainty always means "don't do it".
      - pompino 2y ago
nickpp 2y ago
Because nobody's counting deaths from "not doing stuff". Everybody counts deaths from actions done (things built, products sold, meds taken) but nobody's counting losses from things (like meds) simply missing. In effect we regulated doing stuff so much in the name of safety that we ended up in an infinite "analysis paralysis" mode where the you have to absolutely prove zero harm from new products/services while completely ignoring the harm the current status quo does. See current debates over AI, self-driving cars, and of course, meds.
- tga_d 2y ago
  What do you mean "nobody's counting"? Excess mortality from delayed or denied treatments are measured all the time in medical research. How do you think these drugs get made in the first place? We just had a pandemic where a calculated decision was made that the small risk of myocarditis was massively outweighed by the benefits of mass vaccination. When was the last time you saw a drug ad that didn't list potentially fatal or debilitating side effects? "We need something to solve problem X even if it carries risk Y" is absolutely par for the course.

Why is it that so many people need to die in the name of safety?

by px43 2y ago

Why is it that so many people need to die in the name of safety?

pompino 2y ago

Because you can't honestly presume to know the outcome of a clinical trial of an untested product.

FeepingCreature 2y ago
So run the clinical trial, advertise the product as untested and dangerous-to-lethal in the meantime, and let people make their own choices?
- bartekrutkowski 2y ago
  Smoking is already advertised as dangerous-to-lethal and look how effective it is in preventing people from smoking. In huge oversimplification some crazy or fraudulent people will claim it cures blindness or cold sores, some other people will believe them and will have to deal with the real danger-to-lethal consequences, with the rest of society paying for their medical care afterwards.
  - defrost 2y ago
    > Smoking is already advertised as dangerous-to-lethal and look how effective it is in preventing people from smoking. Pretty effective. In Australia throwing a few diseased lungs on the packs and increasing public awareness has seen usage drop from 35% of the population in 1980 to 11% today. Not all the drop is purely related to advertising, price increases and restricting sale to out of sight locked access in shops have also helped. https://www.tobaccoinaustralia.org.au/chapter-1-prevalence/1-3-prevalence-of-smoking-adults https://www.tobaccoinaustralia.org.au/chapter-1-prevalence/1...
    - mewpmewp2 2y ago
      From another perspective it took massive change in generations and over 40 years of campaigning and it is still a problem for the 11 percent.
      - defrost 2y ago
        Knocking back smoking by two thirds has saved billions for the national health system. On the books, totally worth it.
        mewpmewp2 2y ago
        Sure, but imagine doing the same effort that likely requires critical mass for actual adaption on small obscure medicines and illnesses.
        FeepingCreature 2y ago
        Are they addictive? Then regulate them as addictive drugs. Are they not addictive? Then it seems a stretch to compare them to cigarettes.
        b800h 2y ago
        And cost billions in state pensions. I'm not suggesting that's any sort of counterargument but the costs should possibly be offset against other types of end-of-life care.
        defrost 2y ago
        It's been discussed. The balance has so far fallen on the side of anti smoking policy. Australia is a democracy with many small parties and several quasi independant larger party (three main large parties) members, there's been scope for almost anyone to campaign to repeal anti-smoking policy by either running directly or by lobbying their local of federal rep. People have campaigned for hunting, for cannabis, for many things .. so far no one, to my knowledge, has campaigned to repeal the anti smoking policies.
- jddj 2y ago
  I have a new drug. It's called aceite deserpiente. It's a cure for lyme disease, impotence, ALS, chronic fatigue, cancer and aging. Trials are pending but what are you waiting for, do you want to die for lack of trying? 10k/dose.
  - ben_w 2y ago
    > aceite deserpiente Nice name choice for your example; I was thinking of paracetamoxyfrusebendroneomycin myself, yours is better.
  - FeepingCreature 2y ago
    See, the thing is, I can just choose not to buy it.
    - ben_w 2y ago
      Would you know not to? My mum bought into a lot of homeopathy and Bach flower remedies. Thought she was doing me and dad a favour by getting both, and even "secretly" gave dad doses of the latter (and I was a kid so didn't have much say), so I was fortunate both categories were basically nothing. But her and dad? One of the Bach flower remedies was "for memory"… she got Alzheimer's about 20 years younger than her mother. When my dad was dying of cancer, there was some mineral he thought he was short of (magnesium?), and he didn't realise the homeopathic pills labelled "magnesium" didn't actually contain any magnesium.
      - FeepingCreature 2y ago
        Sure, but look at homeopathy. It's like a virus - you don't optimize for killing the user, because a dead user can't buy more meds, and also you might get sued. Instead you optimize for having as purely placebo an effect as you can. (It's also cheaper.) For that reason, I suspect the scam market is already saturated. Will some people get scammed into taking dangerous chemicals? Sure, but that's already the case cause those aren't regulated as medications. IMO, prevent use of addictive ingredients, but beyond that inform, don't forbid.
- evandijk70 2y ago
  This already happens, it's called 'compassionate use' https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compassionate-use https://www.ema.europa.eu/en/human-regulatory-overview/resea...
hackerlight 2y ago
You've proposed a nonsensical epistemic framework. Knowing isn't binary. You should have a probability distribution over possibilities, based on your experience with similar drugs, expert hunches and animal trials. You then use that to estimate risks and benefits. Then compare this risk-reward profile with the risks of doing nothing -- in this case, near certain death from brain cancer. This "can't presume to know" framework is just sophistry. And I think deep down you know that, if you had a death sentence from brain cancer you'd be begging them to let you in the trial even if they "couldn't presume to know".
- pompino 2y ago
  Maybe the person calling the FDA "nonsensical" should be someone who has actually researched, manufactured, and sold a pharmaceutical product, not some rando on HN. People who dismiss patient safety cannot be taken seriously in my worldview - which thankfully every developed country's regulatory body shares.
- haldujai 2y ago
  You’re missing that we have treatments with known risk/benefits vs research treatment X with undefined risk and reward. It’s extremely challenging if not impossible to obtain informed consent in this situation. We’ve been through this before where a fancy new treatment with promising early/lab results usurped conventional therapy only to later be found inferior. Earlier TKIs and NSCLC are a recent example that comes to mind.
  - hackerlight 2y ago
    It's not undefined, though. That's the point I'm getting at. There is no binary of known and unknown. A tentative picture exists based on animal trials and expert judgment. That tentative picture informs an estimation of the risk to reward profile which is then the basis for an informed decision. This is decision making under uncertainty. It's bad practice to say that uncertainty always means "don't do it".
    - pompino 2y ago

nickpp 2y ago

Because nobody's counting deaths from "not doing stuff". Everybody counts deaths from actions done (things built, products sold, meds taken) but nobody's counting losses from things (like meds) simply missing. In effect we regulated doing stuff so much in the name of safety that we ended up in an infinite "analysis paralysis" mode where the you have to absolutely prove zero harm from new products/services while completely ignoring the harm the current status quo does. See current debates over AI, self-driving cars, and of course, meds.

tga_d 2y ago
What do you mean "nobody's counting"? Excess mortality from delayed or denied treatments are measured all the time in medical research. How do you think these drugs get made in the first place? We just had a pandemic where a calculated decision was made that the small risk of myocarditis was massively outweighed by the benefits of mass vaccination. When was the last time you saw a drug ad that didn't list potentially fatal or debilitating side effects? "We need something to solve problem X even if it carries risk Y" is absolutely par for the course.