5 ms·
And they're slow to avoid approving dangerous treatments, but that's absurd since the patients are already dying. The risk of not approving needs to be taken in
by jonny_eh 2y ago
And they're slow to avoid approving dangerous treatments, but that's absurd since the patients are already dying. The risk of not approving needs to be taken into account.
- WithinReason 2y agoIt's a real life Trolley Problem
- panosfilianos 2y agoRight to try makes this a variation of the Trolley Problem, because the person to pull the lever is the same person that's tied to the tracks.
- ImHereToVote 2y agoThe solution to the Trolley Problem is to perform a "slipping the switch" maneuver. The solution for terminal cancer patients is to let them use any experimental services they please. Next.
- simpaticoder 2y agoYes it's strange to tell a dying person "this drug is too dangerous to try because it may kill you".
- onlyrealcuzzo 2y agoOkay - but what happens when your doctor is getting bribed to say you're dying to get you to try expensive experimental drugs with no evidence of working? In the best case, you end up bankrupt. In the worst case, you end up bankrupt and dead. This is only a slightly more extreme version of the Sackler problem. Deregulation sounds great if you believe everyone is logical and has accurate information to make decisions for themselves. I'm sure there must be a much better solution than what we've got for the people who are dying. But I doubt the answer is to just let drug companies sell anything to anyone and make Medicare pay for it.
- ChrisMarshallNY 2y ago> but what happens when your doctor is getting bribed to say you're dying That was like Robert Stack, in Joe Versus the Volcano[0]. [0] https://www.youtube.com/watch?v=oAB9Y2CVqZU https://www.youtube.com/watch?v=oAB9Y2CVqZU
- krisoft 2y ago> what happens when your doctor is getting bribed to say you're dying We pay people to figure out that this is happening (the police), then we prosecute the doctor and if that is what happened we hit the doctor with the full force of law, and they never walk as a free person ever. We also do the same thing with those who bribed the doctor and they also never walk as a free person again. What you describe already crosses into criminal conduct. We do not need FDA approval process to prosecute it. In fact I’m not sure how the FDA approval of the drug prevents it in your opinion.
- dontlikeyoueith 2y ago> What you describe already crosses into criminal conduct. Does it? How many people from Purdue Pharma went to prison exactly? There are no consequences for the behavior you describe regardless of whether it's technically illegal.
- 2y ago
- pkaye 2y agoThere is the "right to try" act in the US. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try https://www.fda.gov/patients/learn-about-expanded-access-and...
- drewg123 2y agoIt seems like the drug maker needs to participate in the program. What is the rate of participation?
- adamredwoods 2y agoI believe patients need a doctor to advocate for them.
- w10-1 2y agoThere's another difficulty: to get the numbers needed to validate that a drug works, an equivalent large number of people need to enter the trial in the non-treatment arm, typically foregoing other treatment. Many people refuse to join trials for this reason, and that contributes to the delays in completing trials with sufficient power.
- smegger001 2y agoI get the why we in a ideal experiment would like to have a control group but these are human livesvnot rats in lab, so why does every trial need a new control group? If we already know what a baseline untreated group looks like why cant we just compare new drug test to a know control from previous trials thus reducing the need for more dying?
- jpeloquin 2y ago> If we already know what a baseline untreated group looks like There isn't really a single baseline untreated group. For a comparison between groups to be valid, all groups must be obtained by unbiased random sampling of the same population. In a clinical trial, that population is the patients served by the participating clinical center. Patient characteristics differ by time and place. You can try to retrospectively construct a control group using a case control study design, but then you're getting to pick what control group to use, so the results are less reliable (more opportunity for human bias). Unless a treatment is both miraculous in effect and works for everyone, it's hard to figure out if it works.
- mlyle 2y ago> Unless a treatment is both miraculous in effect and works for everyone, it's hard to figure out if it works. Yup. It's worth noting that "all or none" evidence is still considered category 1 evidence on many scales. (If you treat a group where all would be expected to die, and some survive... or a group where many would be expected to die, and all survive). It's only valid for the most dramatic effects, but you don't need randomization. During a safety trial you might come up with "all or none" evidence if your effect is strong enough. But otherwise, you're going to need to compare the treatment to something else. There's no ability to magically draw the exact same population from some earlier trial.
- drewg123 2y agoHas anybody ever just straight up stolen a drug from a clinical trial and had it save their life? If there was ever a case for jury nullification..
- deleted 2y ago[deleted]