5 ms·

We are getting somewhat closer with "Right-to-try" laws: https://en.wikipedia.org/wiki/Right-to-try_law https://en.wikipedia.org/wiki/Right-to-try_law Jake Sel

We are getting somewhat closer with "Right-to-try" laws: https://en.wikipedia.org/wiki/Right-to-try_law https://en.wikipedia.org/wiki/Right-to-try_law Jake Seliger (RIP) wrote about his frustrations with it also: https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/ https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-ce... https://jakeseliger.com/2023/08/02/if-youre-involved-in-drug-development-and-have-first-hand-knowledge-of-the-fdas-torpor-get-in-touch/ https://jakeseliger.com/2023/08/02/if-youre-involved-in-drug...

directevolve 2y ago
https://en.wikipedia.org/wiki/Right_to_repair https://en.wikipedia.org/wiki/Right_to_repair
bsder 2y ago
Jake Seliger's problems weren't really "Right-to-try". The first problem was finding the damn trial in the first place since nobody wants to share information as it might tell their competitors something. And then he had to pass the prerequisites for the trial. The problem there was navigating the US health system that moves like a glacier and either couldn't get a test run fast enough or wouldn't take a test from somewhere else. Finally, after all that, then you reached the "Right-to-try" level where there were different questions of whether to subject him to the treatment based upon whether the doctor thought it might or might not be effective. And through it all, he and his wife understood that the odds were very, very bad. To me, the counterargument to "Right-to-try" are the Alzheimer's drugs. The underlying Amyloid hypothesis appears to be broken and fraudulent and all the drugs based on it have failed miserably. And, yet, one got through FDA approval because the consumer push is so huge and everybody wants something--even if it doesn't work. There is big money behind pushing the boundaries--be very careful about eroding them.
- spott 2y ago
  To me, the Alzheimer’s drug story is an argument for right to try laws. If the drug is available to the desperate, then the push by the public to shortcut the process goes away and the process can be done correctly. Those who are desperate can try, with the understanding that it might not work. The process can continue unmodified because there isn’t a pressure to get the drug out to the public because it is available.
  - bsder 2y ago
    Except that the drug has negative side effects and does not work-not even with the most optimistic interpretations. If you allow that, you're back to HCQ for Covid territory. Or all the autism "treatments". The problem is that most people think of medical outcomes as having 2 results when there are 4. The 2 everybody thinks about are "drug given->patient gets better" and "drug not given->patient gets worse". But there are two more cases. "drug not given->patient gets better" is wonderful in the super-rare cases when it happens and is totally unproblematic. The problem is that the case "drug given->patient gets worse" is common--doubly so for experimental treatments--exponentially so for experimental cancer treatments. And the problem is that it can be due to either the disease or the drug or both. This case is the one that you can't explain in a soundbite. And it's one of the big hurdles in drug discovery. The vast majority of people simply will never get this. We know this. We watched it play out in real time--multiple times. Sure, if you made everybody pass a Bayesian statistics exam before they could get their treatment, that would work. But then you'd be "gatekeeping a cure". Stupidity is the norm, not the exception, and greedy, evil bastards are not unrare. Your rules have to, sadly, take that into account.
    - solatic 2y ago
      That doesn't sound like an argument against the right to try, that sounds like an argument for requiring specific, intentionally frightening language around informed consent. The thing is, probability is a bitch, and emotionally filtered probability is the devil. An experimental treatment for a terminal illness can be 99% likely to result in a quicker or more painful death, but is it really right to deny the 1% chance to someone who understands the statistical choice in front of them?
      - amanaplanacanal 2y ago
        Another facet of this is: should insurance pay for it? Or should the patient bear the financial burden when they want to try a shake-oil cure? Especially in this case when the drug is now FDA approved?
    - mcherm 2y ago
Mockapapella 2y ago
I remember this being posted. It's a bit surreal to read now.

directevolve 2y ago

https://en.wikipedia.org/wiki/Right_to_repair https://en.wikipedia.org/wiki/Right_to_repair

bsder 2y ago

Jake Seliger's problems weren't really "Right-to-try". The first problem was finding the damn trial in the first place since nobody wants to share information as it might tell their competitors something. And then he had to pass the prerequisites for the trial. The problem there was navigating the US health system that moves like a glacier and either couldn't get a test run fast enough or wouldn't take a test from somewhere else. Finally, after all that, then you reached the "Right-to-try" level where there were different questions of whether to subject him to the treatment based upon whether the doctor thought it might or might not be effective. And through it all, he and his wife understood that the odds were very, very bad. To me, the counterargument to "Right-to-try" are the Alzheimer's drugs. The underlying Amyloid hypothesis appears to be broken and fraudulent and all the drugs based on it have failed miserably. And, yet, one got through FDA approval because the consumer push is so huge and everybody wants something--even if it doesn't work. There is big money behind pushing the boundaries--be very careful about eroding them.

spott 2y ago
To me, the Alzheimer’s drug story is an argument for right to try laws. If the drug is available to the desperate, then the push by the public to shortcut the process goes away and the process can be done correctly. Those who are desperate can try, with the understanding that it might not work. The process can continue unmodified because there isn’t a pressure to get the drug out to the public because it is available.
- bsder 2y ago
  Except that the drug has negative side effects and does not work-not even with the most optimistic interpretations. If you allow that, you're back to HCQ for Covid territory. Or all the autism "treatments". The problem is that most people think of medical outcomes as having 2 results when there are 4. The 2 everybody thinks about are "drug given->patient gets better" and "drug not given->patient gets worse". But there are two more cases. "drug not given->patient gets better" is wonderful in the super-rare cases when it happens and is totally unproblematic. The problem is that the case "drug given->patient gets worse" is common--doubly so for experimental treatments--exponentially so for experimental cancer treatments. And the problem is that it can be due to either the disease or the drug or both. This case is the one that you can't explain in a soundbite. And it's one of the big hurdles in drug discovery. The vast majority of people simply will never get this. We know this. We watched it play out in real time--multiple times. Sure, if you made everybody pass a Bayesian statistics exam before they could get their treatment, that would work. But then you'd be "gatekeeping a cure". Stupidity is the norm, not the exception, and greedy, evil bastards are not unrare. Your rules have to, sadly, take that into account.
  - solatic 2y ago
    That doesn't sound like an argument against the right to try, that sounds like an argument for requiring specific, intentionally frightening language around informed consent. The thing is, probability is a bitch, and emotionally filtered probability is the devil. An experimental treatment for a terminal illness can be 99% likely to result in a quicker or more painful death, but is it really right to deny the 1% chance to someone who understands the statistical choice in front of them?
    - amanaplanacanal 2y ago
      Another facet of this is: should insurance pay for it? Or should the patient bear the financial burden when they want to try a shake-oil cure? Especially in this case when the drug is now FDA approved?
  - mcherm 2y ago

Mockapapella 2y ago

I remember this being posted. It's a bit surreal to read now.