3 ms·
You might be right, at least in that I'm probably too loose with the jargon. Specifically my complaint is on the "controlled clinical trials" being the "only wa
by Jach 8y ago
You might be right, at least in that I'm probably too loose with the jargon. Specifically my complaint is on the "controlled clinical trials" being the "only way", and thinking about it perhaps it's just focusing too much on a less than ideally precise statement from Lowe.
This ties back to the Right To Try stuff though. Suppose there's a new drug researchers have reason to believe might work, maybe it's even synthesized with an individual in mind, so they administer it to a patient after getting consent and (more importantly in the right-to-try discussion) legal approval. The patient either gets better, gets worse, has no change, or develops some new problems. Whatever the case, the data are recorded, it's a study of some sort. I might tend to see this as an observational study but I should probably use the more precise jargon and follow the split of only no-influence being observational and any-influence being "experimental", so maybe the best category is "field trial". Still, it's definitely not a (randomized double-blind gold standard) controlled clinical trial, but can we still learn anything from it? Did the drug work? Did the drug cause any state change? If another drug had been taken would the result have been the same? Causal inference people say you can make (qualified) claims from such data. But it seems that the regulatory mindset at least (which will lag practice, though I don't think practice has changed dramatically enough to influence regulation yet) is "we can't answer these questions at all" and so they require the very expensive (source of the majority of costs for new drugs) controlled clinical trial.
This reminded me of an old thread I keep bookmarked... https://news.ycombinator.com/item?id=3819346 https://news.ycombinator.com/item?id=3819346 "The entire thrust of our medical regulatory system ... is the belief that it's better for 1000 patients to die of neglect, than 1 from quackery. ... The entire process we call 'drug development' is an attempt to gain six-sigma confidence that we are not practicing quack medicine." My real complaint is with this sort of mindset, which I took Lowe to be spreading with his statement about controlled clinical trials.
- eesmith 8y agoI know only somewhat more than hearsay about clinical trials, so I'm not really qualified to have this discussion. I know that trials are not always between placebo/"no-influence" and "any-influence." They are sometimes between current best practice and possible new best practice. I believe the recent case of the woman treated for breast cancer, which I mentioned previously, is an example of your "suppose" case. Another might be the first trial of injectable penicillin was on Reserve Constable Albert Alexander. It was clear within 24 hours that it was effective. So certainly it doesn't require randomized double-blind trials. Then again, Lowe said "controlled clinical trials", which I suspect may include more than the 'gold standard' of clinical trials. There's an old joke about how there hasn't been a controlled trial about the effectiveness of parachutes. https://www.bmj.com/content/327/7429/1459 https://www.bmj.com/content/327/7429/1459 . I don't think the medical field as a whole agrees with "the most radical protagonists of evidence based medicine" (quoting from the abstract) to conclude that we therefore can't be certain about its effectiveness. I read the comment from 2012 that you pointed to. I think it is an opinion with only a tenuous basis in evidence. Other countries have different requirements for care. I pointed out elsewhere in this thread how people from the US go to Mexico for treatments which are illegal in the US. (Note: Mexico is not full of Nazis as moldbug exaggeratedly suggested must be the case for that to happen.) If it were so simple as closing the OODA loop, then we would expect amazing treatments to come out of these countries. Or as Lowe pointed out in the quote I gave earlier: > Many states have passed their own right-to-try laws (in various forms), and if there has been any decrease in human suffering or advance in medical knowledge through them, I have missed it. To get specific, when Colorado passed its own law in 2014, one of the first companies that announced plans to offer treatments under its provisions was a stem-cell company, Neuralstem. And guess what? None of their treatments ever worked. Most things don’t. Since the lower standard doesn't seem to help, why lower the standard? What evidence is there that 1000 or more patients die of neglect for every one which dies of quackery?