7 ms·

> Clinical implications: While more research will be needed before trials in humans can begin Why? Seriously, think about it. Most people with pancreatic can

• snapcaster 9mo ago
  Yeah putting myself in the shoes of someone with this disease or a loved one with this disease I would be so incredibly angry that we weren't allowed to try something when the alternative is certain death
  • reg_dunlop 9mo ago
    It's the prisoner's dilemma. Or more succinctly: Take something and possibly live, or take nothing and certainly die.
    • bobbylarrybobby 9mo ago
      That's not what the prisoner’s dilemma is.
      • petcat 9mo ago
        Yeah this is more like a Pascalian Gamble [1]. If you try nothing, then you are assured to die as God wanted. If you try something, then you might live, but then God hates you. [1] https://en.wikipedia.org/wiki/Pascal%27s_wager https://en.wikipedia.org/wiki/Pascal%27s_wager
        • deleted 9mo ago
          [deleted]
        • Liquix 9mo ago
          It is like Pascal's Wager but has nothing to do with "what God wanted" or "God hating you"... It's more "if it doesn't work the outcome is the same anyway" (eternal oblivion in Pascal's case, certain death in this case), therefore why not give it a shot in case it does work.
          • gverrilla 9mo ago
            Warning to anyone reading this: Pascal was NOT a self-help writer.
  • fiddlerwoaroof 9mo ago
    I think you could mitigate some of the problems by making the drug company pay for the treatment before approval.
  • kulahan 9mo ago
    There is a lot of money to be made selling snake oil to the desperate, so we definitely want regulation…
    • DennisP 9mo ago
      So don't let people sell the drugs at a profit, at early stages.
      • Induane 9mo ago
        Ding ding ding this is the way. Sell at cost. Real cost, like cost of making. NOT a cost that includes R&S amortized across the batch.
        • vibrio 9mo ago
          Not even cost plus? Not sure how that works, from the viewpoint of economic incentives.
          • ulfw 9mo ago
            It's literally free data for efficacy / later sales.
            • vibrio 9mo ago
              So charging patients/insurance companies at cost to fund the clinical studies?
              • DennisP 9mo ago
                Clinical studies today are funded entirely by the pharma companies, keep that. Selling at cost of production would be something extra, for patients who want the drugs but aren't enrolled in an actual study. The company doesn't get solid data it can use for regulatory approval, so making them donate the drugs in that case seems excessive. A downside would be that for drugs that don't cost much to produce, patients might be less willing to enroll in the studies, given the chance of getting a placebo. That could be handled by shutting down the informal access while the study is enrolled, for anyone who's eligible. I'm sure there are other wrinkles that would need to be considered too.
• phoronixrly 9mo ago
  Ethics is a topic I would never trust HN on.
• John23832 9mo ago
  There are already many "compassionate use" exceptions out there already. I've family friends be grated that. It helps the pharma company as well as the patient. I'm sure that will happen here.
• huhkerrf 9mo ago
  Things are, at least, getting better with the passage of right to try laws: https://en.wikipedia.org/wiki/Right-to-try_law https://en.wikipedia.org/wiki/Right-to-try_law These drugs seem to all be only allowed after Phase 1 trials, so still not quite at the level you're describing here.
• WinstonSmith84 9mo ago
  I had a relative who died from this around 20 years ago. 50yo slim, sportive and healthy and after going to a diagnostic as she didn't feel good, she was gone within a few months .. So yeah, if there is even a slight chance it works, this should be tried and that'd save people :(
• dylan604 9mo ago
  > what's the worst that can happen? The patient dies from complications of the drug's use before the cancer.
  • post_break 9mo ago
    If I had 6 months to live, and had no other options, I wouldn't care if a drug killed me in 10 days. Give me the option.
    • dylan604 9mo ago
      bigPharma doesn't care about that. They care about the publicity of their drug killing someone faster than the cancer.
      • ineedaj0b 9mo ago
        No. No no no. Big Pharma needs good data. And they have annoying FDAs/whatever-regulations-body slowing them down. If you have a serious disease they might not mind you taking it. But if you have a serious disease plus your kidneys have already shutdown - w/e drug won’t save you. The death counts as a negative. “Let me take it anyway” well fine but it’s not some huge conspiracy.
    • WJW 9mo ago
      It's not just those two choices though. It could be "6 months in relative comfort" and "10 days begging each minute to die but you can't because you're borderline unconscious". Or anything in between. Just saying. Medical guidelines are there for a reason and are often, as they say in the military, "written in blood".
      • tw04 9mo ago
        > "10 days begging each minute to die but you can't because you're borderline unconscious" They aren’t going to know if it does that until they give it to a human in the first place. The only difference in giving it now is they lack a control group.
• wat10000 9mo ago
  We might take it too far, but the fear of quack medicine is extremely rational.
  • standeven 9mo ago
    Every time I see homeopathic medicine on the shelves in a pharmacy, I think we’re not taking it far enough.
    • Scoundreller 9mo ago
      Every time I see homeopathic medicine on the shelves in a pharmacy, I think we’re going to need 100000x more
• zen928 9mo ago
  IMO, if you view your question from the ethical framework of "do no harm" i.e. the hippocratic oath instead of "move fast and break things", I can clearly see reason for the apprehension. The standards aren't positioned to catch "quack medicine" but to require full understanding before asking someone else to put something in their bodies. It's somewhat of an entitled stance that youd be okay with other people possibly needlessly dying in any circumstance for something experimental, and not one I'd ever want taken as an official stance by a regulated medical body.
  • A_D_E_P_T 9mo ago
    Consider what the oath actually says. > I will not give poison to anyone though asked to do so, nor will I suggest such a plan. Similarly I will not give a pessary to a woman to cause abortion. But in purity and in holiness I will guard my life and my art. Now consider that doctors in Canada and Europe are literally administering MAID as we speak. In other words, administering poison with intent to kill. Further, consider that doctors have participated in administering lethal injections, etc. I could go on all day. But you'd invoke the Hippocratic Oath to deny people with fatal diseases access to potentially curative treatments, though admittedly experimental? That's a funny view of the oath you've got there, and either an uninformed or very funny take on medical ethics, as well.
    • Nursie 9mo ago
      That's not an oath that many modern doctors will have sworn though - (From wikipedia) As of 2018, all US medical school graduates made some form of public oath but none used the original Hippocratic Oath. I imagine the story is similar elsewhere.
• deleted 9mo ago
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• yieldcrv 9mo ago
  good news, are current FDA has many ways of fast tracking a treatment and a willingness to do so
• dyauspitr 9mo ago
  That’s because we have a system that financially punishes fraud and mismanagement which is what we want and should keep. There should be a way for terminal cases to volunteer for early trials and I believe there is already legislation that provides that but it’s not used and funded enough.
• bsder 9mo ago
  > Our society's morbid, irrational fear of quack medicine It is not an irrational fear. Brandolini's Law applies: "The amount of energy needed to refute bullshit is an order of magnitude bigger than that needed to produce it." The only way to prevent quackery is to cut it off hard before it gets started. Wakefield demonstrated the disaster that happens when you don't. (And if you have been reading this site for very long, you know the experimental treatments are already around--we're not currently lacking for possible cancer treatments. The problem is finding the trial. Then the problem is getting people through the process and then getting them to the trial. See: "Please be dying, but not too quickly": https://bessstillman.substack.com/p/please-be-dying-but-not-too-quickly https://bessstillman.substack.com/p/please-be-dying-but-not-...)
  • A_D_E_P_T 9mo ago
    Even if I grant that argument, what I've described isn't even quackery. It is legitimate medical research and experimentation, and what doctors in olden times would call a "heroic" intervention -- but, sadly, now this sort of thing has become collateral damage in the war between medicine and quackery. And patients are the ones who die and suffer because of it.
    • bsder 9mo ago
      The general public, as a group, cannot identify quackery. People died from bleach and horse dewormer to prove this. The continuing career of Mehmet Oz also demonstrates this. There will always be more malevolent actors looking to take advantage of people than there are benevolent actors able to protect them. Standard rules and laws are an attempt to at least protect the majority of the people the majority of the time. Like anything, rules are never perfect, and you have to weigh the limitations against with the benefits. As someone who has literally trawled the cancer trial databases for people, lack of trials is not the main problem--finding the appropriate trials, on the other hand, is terribly difficult. If you really want to help people, apply AI to help common people search all the public cancer trial filings to connect up the patients and the doctors. That would do far more good, far faster than changing laws and rules around last ditch experimental treatments. You won't become rich, but you'll help medical science a lot, and you might even save a life here or there.
• jmward01 9mo ago
  The ethics of life and death are murky at best. When is it acceptable? 6 months to live? 1 year to live? 5 years? What is the cut point? The answer is, there isn't a clear answer. Yes, that is a cop out, but it is also true. I agree with allowing people of sound mind to make informed healthcare decisions towards the end of their lives that involve high risk. but I would be wary of weakening the process too much. We should have a push-back because people in these positions are exceptionally vulnerable and therefore easy to take advantage of and, even worse, likely to be unable to defend against abuse for very long. Weakening this process would likely lead to drug companies doing what they always do, abuse their position for money. Why even go to expensive traditional trials? Just give some promising, cherry picked, results in a press release and now people are coming to you signing every waiver and paying their last penny to live next to the trial that will kill them because the drug wasn't even close to ready. I would likely feel very different if I was near death, but that is the point isn't it? Again, I'm not saying this shouldn't be an option. I just think it needs a lot of scrutiny and a high level of skepticism.
• boogrpants 9mo ago
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• draw_down 9mo ago
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• tansey 9mo ago
  Somebody has to pay for the trial. Drugs are expensive and the amount needed to dose a single person is orders of magnitude more than mice. So who funds the study? If it's the government or philanthropic fund, you have to put in a grant and show that it's competitive in terms of preliminary results etc. If it's the drug companies, you have to deal with lots of complicated things with combination therapies. Drug companies don't like their drug paired with other drugs that aren't in their portfolio. They also need to see a way to make a profit on it, which means they need to evaluate whether this is the most likely successful trial, assess bang for buck etc. If you want to go compassionate use, then you need to get the pharma to donate the drugs or insurance to cover it. This is spain, so I guess insurance is just the government since they have universal healthcare. I have no idea how that works but I am guessing it doesn't move fast.
  • aorloff 9mo ago
    > So who funds the study? The End Users !!!! This is why medicine is too important to leave to drug companies, governments, or philanthropic funds. What we need is an open source medical trial system with some bona fides
• vibrio 9mo ago
  Knowing whether drugs work isn’t trivial. Patients are typically very heterogeneous in their responses to drugs. For example, pembrolizumab (the most successful cancer drug ever) typically only works in, say 30% of patients depending of the cancer type. Just throwing therapeutic ideas out there and letting physicians sort out how to use them and in which patients, isn’t a panacea. Looking at clinical data can be like star gazing even in planned studies. Structured, statistically powered studies, and costly rigorous assays on biomarkers and correlative studies are essential for understanding how and in what patients drugs are working. I’m all for expanding access to drugs, and there is abundant waste and greed in big Pharma and venture, but there are also people doing hard expensive science, medicine and manufacturing. Im not sure I have the answer. A “yelp for medicine” won’t improve immediate outcomes, nor longer term understanding and progress. A great and excruciating read about the tension there is a real-time blog (the story’s story) that was written by Jake Seliger unt he passed in 2023.
• jjk166 9mo ago
  If nothing else, it's not the only hail mary you could potentially go out on. Would you give up the potential of being part of a trial for a drug that has actually done the work and demonstrated real promise in various pre-trial tests just to take a gamble on this alternative which hasn't even had the initial test replicated yet? Further there is the potential for a false negative. If they don't understand enough about how the drug would work in humans, they may trial inappropriate doses or delivery methods. If those don't help or make things worse, it could be mistaken for the drug being ineffective and lead to the whole line of inquiry being abandoned. Then not only do you die, but countless others are potentially harmed by an effective version not being developed. Finally, cancer treatments aren't just for the terminal. Drugs which primarily help during the early stages by necessity need to be trialed on people who still have a chance, maybe even a decent one, going with other, well established treatment options.