3 ms·

People are, perhaps understandably, very eager to advance at a faster pace, always a faster pace. Nowhere is that more evident than in the case of people facing

People are, perhaps understandably, very eager to advance at a faster pace, always a faster pace. Nowhere is that more evident than in the case of people facing death regardless, but in addition to the issues you raised (early failures can lead to even worse delays) there are other ethical concerns. Terminally ill people are often understandably desperate, and I would be too in their position, no doubt about it. Their families are desperate, often their doctors are desperate. That doesn't mean that their remaining life doesn't have value though, or that cutting it weeks, months or years short isn't a problem. I think that's often lost on people, and in a more frightening way, people who are all-to-eager to use the terminally ill as ultimately disposable test subjects for unproven treatments. If it was JUST down to safety then I could see the point to an extent, but as you said efficacy is a big open question too. Of course if you're facing death then you may well want to roll the dice, but the question there too is how well you really understand the odds. The understandable implication in a lot of the discussions around this issue is that if only regulators were a bit faster, people like the author wouldn't die. The reality is grim though, most of these experimental drugs and therapies are not effective, regardless of whether or not they're safe.

causality0 3y ago
We let people have assisted-suicide for reasons from homelessness to hearing loss, twenty thousand people a year. Why do we respect their self-ownership when they're trying to die but not when they're trying not to die? Why do we get to decide what is and isn't worth the risk?
- EA-3167 3y ago
  Because they're trying to die, they're literally getting what they want, guaranteed. Having said that I don't agree with assisted suicide for the reasons you listed. Either way it's not as though people seeking death are being mislead as to the odds, are engaging in desperate reasoning that they'll be the lucky ones who get to live a bit longer. You offer someone death, they get death. This is about people desperate for cures and treatments that probably won't work, and may well give them the opposite outcome from what they hope for. There is a difference in kind.
  - causality0 3y ago
    Either way it's not as though people seeking death are being mislead as to the odds, are engaging in desperate reasoning that they'll be the lucky ones who get to live a bit longer This applies just as much to approved treatments as unapproved, for the same reasons, and has the exact same solutions such as having a third party with no vested interests explain to the patient. In fact it has those problems less than approved treatments because the companies are being paid by the insurance company for the approved treatments but not the experimental ones.
    - EA-3167 3y ago
      The key is that the approved treatments are proven to have the requisite efficacy, the risks that come with that are an acceptable tradeoff. The unapproved, often largely untested world of early breakthroughs doesn't have that guarantee of potential efficacy, it often JUST has risks.
      - tux3 3y ago
        It may help to not view the options as a binary choice between drugs approved under the current process and any drug not currently approved. What constitutes the acceptable tradeoff is the heart of the matter. On the one hand, even the current approval process does not always guarantee efficacy (Aduhelm to mention it by name). Medical trials work with considerable uncertainty, and the risk/benefit tradeoff is always a question of probabilities. Even with the current process, there is no certainty or guarantee. It is possible to take those probabilities and to talk about the expected number needed to treat (NNT) for a medication, the expected side effect profile, how many people might live and how many might die. Things that may sound cold, but that are already routinely done today. It is hard to know where the tradeoff should be, how much margin of error is the right amount before something is approved, knowing that there is uncertainty even in large trials, but it's not a choice between the totally unapproved and the status quo. (Better yet, we should not model the choice as a single parameter that goes from more choice & more snake oil to less choice & more safety. It's also often possible to improve one aspect of a bureaucracy without it being a zero-sum game.)
- civilitty 3y ago
  > Why do we get to decide what is and isn't worth the risk? It's not their risk to take. Getting a drug to market is a complex process that can be derailed by any number of mistakes ranging from the mundane like improper blood draw during clinical trials to the tragic like accidental deaths that puts public pressure on the FDA to shut it down or spook away investors. Any hiccup in this process can kill it and once a patent expires, the chances of someone bringing that drug to market is almost zero, regardless of its efficacy. The vast majority of drugs and therapies are developed via private investment and many companies go public before they make even a cent of revenue to fund the clinical trials. Public sentiment is the driving force behind their stock prices because they're literally forbidden from making money until the FDA approves their drug. Lots of them go bankrupt every year before finishing clinical trials or releasing a product and rushing the process is quick ticket there. Patients don't get to put at risk the decades of good a drug can do because they're desperate and afraid of dying.
  - thedragonline 3y ago
    I'm not sure removing options from the desperate and dying is a good idea. Those with means will just ignore your concerns and the rest will have _nothing to lose_.
    - EA-3167 3y ago
      I can't find it anymore, but there was a paper or maybe study looking into the question of healthcare outcomes for just such "people of means." Iirc there was some interesting data which showed being able to afford doctor shopping and concierge service was sometimes correlated with poor outcomes compared to the standard of care overall. I think it makes sense, the patient can demand what they want and then get it, but they're not necessarily armed with the knowledge or perspective to make the informed decision. If they can afford to find a doctor who values a lot of money over anything else though, they can get it, and that might not work out so well for them. Michael Jackson, Joan Rivers and Lisa-Marie Presley for example would probably all still be alive if they didn't have the money to simply buy the healthcare they wanted, damn the consequences and cost.

causality0 3y ago

We let people have assisted-suicide for reasons from homelessness to hearing loss, twenty thousand people a year. Why do we respect their self-ownership when they're trying to die but not when they're trying not to die? Why do we get to decide what is and isn't worth the risk?

EA-3167 3y ago
Because they're trying to die, they're literally getting what they want, guaranteed. Having said that I don't agree with assisted suicide for the reasons you listed. Either way it's not as though people seeking death are being mislead as to the odds, are engaging in desperate reasoning that they'll be the lucky ones who get to live a bit longer. You offer someone death, they get death. This is about people desperate for cures and treatments that probably won't work, and may well give them the opposite outcome from what they hope for. There is a difference in kind.
- causality0 3y ago
  Either way it's not as though people seeking death are being mislead as to the odds, are engaging in desperate reasoning that they'll be the lucky ones who get to live a bit longer This applies just as much to approved treatments as unapproved, for the same reasons, and has the exact same solutions such as having a third party with no vested interests explain to the patient. In fact it has those problems less than approved treatments because the companies are being paid by the insurance company for the approved treatments but not the experimental ones.
  - EA-3167 3y ago
    The key is that the approved treatments are proven to have the requisite efficacy, the risks that come with that are an acceptable tradeoff. The unapproved, often largely untested world of early breakthroughs doesn't have that guarantee of potential efficacy, it often JUST has risks.
    - tux3 3y ago
      It may help to not view the options as a binary choice between drugs approved under the current process and any drug not currently approved. What constitutes the acceptable tradeoff is the heart of the matter. On the one hand, even the current approval process does not always guarantee efficacy (Aduhelm to mention it by name). Medical trials work with considerable uncertainty, and the risk/benefit tradeoff is always a question of probabilities. Even with the current process, there is no certainty or guarantee. It is possible to take those probabilities and to talk about the expected number needed to treat (NNT) for a medication, the expected side effect profile, how many people might live and how many might die. Things that may sound cold, but that are already routinely done today. It is hard to know where the tradeoff should be, how much margin of error is the right amount before something is approved, knowing that there is uncertainty even in large trials, but it's not a choice between the totally unapproved and the status quo. (Better yet, we should not model the choice as a single parameter that goes from more choice & more snake oil to less choice & more safety. It's also often possible to improve one aspect of a bureaucracy without it being a zero-sum game.)
civilitty 3y ago
> Why do we get to decide what is and isn't worth the risk? It's not their risk to take. Getting a drug to market is a complex process that can be derailed by any number of mistakes ranging from the mundane like improper blood draw during clinical trials to the tragic like accidental deaths that puts public pressure on the FDA to shut it down or spook away investors. Any hiccup in this process can kill it and once a patent expires, the chances of someone bringing that drug to market is almost zero, regardless of its efficacy. The vast majority of drugs and therapies are developed via private investment and many companies go public before they make even a cent of revenue to fund the clinical trials. Public sentiment is the driving force behind their stock prices because they're literally forbidden from making money until the FDA approves their drug. Lots of them go bankrupt every year before finishing clinical trials or releasing a product and rushing the process is quick ticket there. Patients don't get to put at risk the decades of good a drug can do because they're desperate and afraid of dying.
- thedragonline 3y ago
  I'm not sure removing options from the desperate and dying is a good idea. Those with means will just ignore your concerns and the rest will have _nothing to lose_.
  - EA-3167 3y ago
    I can't find it anymore, but there was a paper or maybe study looking into the question of healthcare outcomes for just such "people of means." Iirc there was some interesting data which showed being able to afford doctor shopping and concierge service was sometimes correlated with poor outcomes compared to the standard of care overall. I think it makes sense, the patient can demand what they want and then get it, but they're not necessarily armed with the knowledge or perspective to make the informed decision. If they can afford to find a doctor who values a lot of money over anything else though, they can get it, and that might not work out so well for them. Michael Jackson, Joan Rivers and Lisa-Marie Presley for example would probably all still be alive if they didn't have the money to simply buy the healthcare they wanted, damn the consequences and cost.