7 ms·

This has been a common complaint for decades. We always want to try rush experimental drugs/procedures that “show promise”. How often do these drugs, etc turn

• EA-3167 3y ago
  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.)
• appplication 3y ago
  > we’ll know that we at least we made significant effort, and gave everyone a better chance, rather than settle for a “Hail Mary” drug near the end. I think this is a sensible take for someone who is not facing their own imminent mortality. But no matter what we do, the game theory of terminal diagnoses means there will always be incentive to go for a Hail Mary in the end.
• fallingknife 3y ago
  3 years ago we wanted to rush the COVID vaccine and it probably saved millions. I don't understand why we can't let people make risk reward judgments. Yes probably more people will die, but they were not forced.
  • torstenvl 3y ago
    I agree. Dying in anguish at the hands of your own government is far worse than dying having tried everything you could.
  • EatingWithForks 3y ago
    The COVID vaccine already had an existing model to work from that was already ready to go and approved in the SARS-COV-1 vaccine nearly a decade earlier.
  • inhumantsar 3y ago
    I agree with you but I also understand the argument that being given the choice between certain death and uncertain death is a form of coercion
    • fallingknife 3y ago
      And I'm sure that those people dying are saying to themselves "well at least I wasn't coerced"
  • lucianbr 3y ago
    Did you never experience the situation where someone you care about is making a choice you think is wrong, and you want to protect them from themselves? I'm not saying this is the right thing to do. I'm just trying to explain how it happens. People don't make good risk judgements in general, and other people think that it is good to do good by force. This is why seat belts are mandatory, smoking is discouraged, drugs are illegal, public companies traded on exchanges are strongly regulated, and so on and so forth. > Yes probably more people will die You really don't understand why we choose the option where less people die? We value life, I guess.
• sleight42 3y ago
  Just "invest more"? Who does the investing? Not "The Market". The incentive isn't to cure but to treat. The Market wants (repeat) customers. The government? At least, in the US, we've been dismantling the government's ability to do this since at least Reagan. Even our so-called Liberals aren't pushing hard here. You'd have to look to the "fringe" Progressives within the Democratic Party to even come close. And why? Because "fuck you, I've got mine" may as well be the national motto of the USA at this point. People will bristle at this, certainly. Look at Biden: he's done so much! Biden is no FDR. We need a real social safety net in this country. And, yes, we need a "right to try", even if it means waiving malpractice rights in those cases.
  • GuB-42 3y ago
    > The incentive isn't to cure but to treat. The Market wants (repeat) customers. I am fed up with this argument. Compared to a recurring treatment, a cure will: - destroy the competing recurring treatment - sell particularly well initially, when you still have the patent, potentially at a high price - not stop the influx of repeat customers, since as long as people are alive, they will need medicine, and people who are now healthy because you cured them will be more likely to have a well paying job that will pay for expensive drugs If that argument was true, no one would do vaccines, especially considering that most vaccines are not particularly expensive.
    • sleight42 3y ago
      Vaccines aren't a cure. They require repeat customers. You're making my argument for me.
      • haldujai 3y ago
        Most vaccines only require 1-3 injections. This example is poorly chosen for a different reason explained in my comment. Alternatively, we can look at novel curative intent therapies for cancer like focal ablation or stereotactic radiation. The recurring customer alternative of chemo/immunotherapy or the conventional surgical option are at least an order of magnitude more expensive. You won’t find much novel systemic therapy that’s curative intent because it’s really hard (?impossible) to do, not because the system wants to make more money slowly killing patients.
• matteoraso 3y ago
  >How often do these drugs, etc turn out to effective? This is a big point a lot of people ignore. I feel terrible for the author, but if there hasn't been a single drug invented so far that has any real chance of curing him, it's extremely unlikely that this one out of reach drug is going to be the drug that can save his life. I don't really know much about medicine, but I'm pretty sure that progress is usually incremental as well, so you start out with drugs that cure some patients and work from there instead of having some massive breakthrough.
• jasode 3y ago
  >I think the solution is to invest more into medical research now, The author is arguing that terminally ill people (with a few months left to live) -- like him -- would be willing participants in trials to help medical research. They already know that mRNA drug or whatever likely won't cure them. It's possible some new scientific knowledge of the drugs' effects can still be gained even when it doesn't cure them. Given the realistic odds, the primary purpose (from society's perspective) of letting of terminal patients participating in unproven drug trials would be medical research rather than "Hail Mary cures". From the patient's perspective, of course they hope it improves their health.
  • mlyle 3y ago
    There's a lot of problems with it, though. Even if advancing medical research was the main goal-- ad hoc use in dying patients provides unclear data. Medical research wants clear inclusion criteria, metrics, reduced statistical noise from similar patients, predeclared outcome measures, and economies of scale in running trials. We already let terminal patients participate in medical research, but only inviting patients at times and meeting criteria that optimizes the research. Also, only where IRBs have found it to be ethical-- this means not replacing a drug with proven benefit with an experimental treatment with unknown benefit recklessly. But terminally-ill patients push for inclusion beyond this: to be dosed when there is not an active trial, or to be dosed when they are so sick that the outcome would be difficult to interpret or compare, etc. This isn't for medical research, this is for self-preservation.
    • jasode 3y ago
      >There's a lot of problems with it, though. [...] Medical research wants clear inclusion criteria, [...] , but only inviting patients at times and meeting criteria that optimizes the research [...] But terminally-ill patients push for inclusion beyond this: to be dosed when there is not an active trial, [...] Your objections are sensible but that's beyond the scope of this author's argument. I'm just taking author's following comment at face value: ">The FDA was loathe to approve initial mRNA human trials, even when those trials would have been full of people like me: those who are facing death sentences anyway." If it's the drug researchers who don't want the author as a test subject, that's understandable. But he's arguing the _FDA_ shouldn't be the one blocking his participation. For the situations where there's "no active trial" caused by the FDA not greenlighting the experiments, then of course, the complaint will be that "terminally ill patients want to participate in trials that don't exist". That's sort of a circular argument -- caused by the FDA. Again, if there's no active trial because the medical researchers themselves are not yet ready, that's understandable. But if the drug scientists are ready but the FDA is not, that's a different issue and it's the focus of the author's essay. All that said, I don't know how much scientific progress the FDA holds back because of "safety". I'm just trying to explain the author's position.