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by mmkhd 2238 days ago
> they will let their patients and colleagues die first.

No! They will definitively not let their patients and colleagues die firs! They will prevent you from killing them!

You might believe in youRe therapy, but the vast amount if novel therapies will have (novel) adverse effects and you will haVe to supply the prove that your therapy will do less harm than doing the conventional thing. We have clinical trials to administer new therapies in a controlled and ethical way to cause the least harm. Just trying things will kill more people than it helps. The vast amount of new ideas do more harm than they help. Look at chloroquine and what a shit show it is, because everybody just tried it willy nilly. The side effect of harming Lupus patients who could not get their medicine alone caused tremendous unintended harm. And that wasn’t even harming because if administering a useless therapy with serious side effects. Move fast, fail fast and fail often aren great principles for developing software but they have no place in developing therapies. (I actually wanted to hurl swear words at you. But that helps nobody. It is true that medical research is overregulated and could be improved Bit there are reasons for that. Throwing all regulations away is just Trumpish behavior.)

1 comments

Please explain to me the risks of nebulized ethyl alcohol, which is what I am proposing? Ad hoc dismissals without the consideration of scientific literature reviews of alcohol inhalation - which there are several review papers published - demonstrates a serious lack of critical thought in medicine. Obviously to compare it to chloroquine is absurd.

Your point about supplying the safety data is exactly where the roadblock is found. I’ll update you when the device is approved by the FDA and voila these objections mysteriously disappear ;)

An ad hoc (fallacy) dismissal would be one that doesn't actually address the central question or finds an excuse that is not generalizable to similar circumstance without supporting evidence for the exception. Even if you think the GP's reasoning was wrong, the GP comment did provide specific reasons for their argument, which was itself an argument generalized to medical practice & research. Not ad hoc.

Further, if the GP had prior assumptions about these possible treatments being wrong, you commit the same error in the opposite direction with your casual assumption that your approach is right, that the FDA will not only approve the thing, but that the objections will also lose all validity. Even if approved, the objections may still have merit. The objection need not be completely wrong in order for the FDA to decide the balance of risk weighed in favor of approval.

Finally, the idea of using nebulized ethyl alcohol is interesting! I hope it works. It is, however, extremely easy to find information on the dangers of inhaling alcohol fumes. If it is a viable treatment path, patients are likely to be extremely sensitive to dosing levels. Recipients would also, by definition, be high-risk, making the safety issues more uncertain. It is not, on it's face, unduly obstructionist to be highly skeptical of such a treatment without a decent amount of evidence.

Edit: I even partly agree with your sentiment that this is a time when some (very careful) risks may need to be taken that ordinarily wouldn't be. But your comment conveys a strong sense of arrogance, of unassailable certitude. I hope I am wrong in that assessment: Someone looking to take these sorts of risk right now should be approaching them with the utmost humility. This makes your tone very disturbing.

Thank you for your reply, but I never claimed an ad hoc fallacy? Nor did I claim infallibility? I am insinuating the disregard for novel therapies in a pandemic because there is no data conceived (ad hoc dismissal or excuse), and not because of an intuitively perceived judgment on its harm, which is readily discernible from the collection of scientific literature on alcohol inhalation I have found and can share, is a testimony to healthcare bureaucratization.

For instance, the banning of nebulization in hospitals for fear of viral aerosolization published in a faulty NEJM letter[1] is preposterously cautious. By this logic, Lysol disinfectant sprays ought to be banned too, even though it’s recommended by the CDC. So this “arrogance” you sense is probably because it is apparent to me I am hungrier to save lives than (many) doctors and hospital administrators who won’t take a chance to even measure the risk to accumulate much needed experimental evidence; even if their patients are willing! Hippocratic Oath is the retort.

Frankly, “no data no dice” does not cut it when confronting such a global humanitarian challenge. The medical profession appears to be just that - licensed occupational employees motivated about retaining their jobs. Hence my snarky expectation that this will be an easier, ie quicker, sale if/when the nebulizer has been rubber stamped by the FDA. No one was ever fired for buying IBM

[1] https://www.nejm.org/doi/full/10.1056/NEJMc2007942

Also, thank you for a thoughtful response. I can appreciate your eagerness to save lives too, but I would not so easily cast doctors as any less eager. A doctor that avoids experimental treatment is doing so precisely because they believe they are acting in a patient's best interests.

Front-line doctors simple have a different perspective: There are many prospective treatments that might show promise. Most will not work. Many may have their own catastrophic effects. At the same time, doctors must make immediate decisions on how to treat patients, without the luxury of time to review all prospective experimental treatments, most of which lack sufficient data to make a rapid determination of their risk. And remember their foundational, ancient oath: "First, do no harm". If that oath engenders a certain amount of conservatism in treatment choices, you should not berate the doctors themselves as deficient: Your issue is with the fundamental philosophy of medical practice.

I am glad you are hungry to save lives. But remember humility: Any number of significant failures that cost lives can be found will minimal searching, and undoubtedly most involved were eager to save lives as well. The drug combo FenFen comes to mind: I'm sure the researchers involved were eager to save lives and improve the health of obese people, but they're efforts caused serious heart problems in up to 30% of those taking the drug. Medical history is littered with failures and death. You must remember that. If doctors are conservative in their treatment choices, they have good reason, and should not be condemned for it. You'll win no people to your cause if you vilify those you seek to convince, all you will do is attract people who are already inclined to agree with you.

My apologies, when you said "ad hoc dismissal", I assumed you meant the fallacy. Your phrasing was an appropriate way to state that someone had committed that fallacy.
> I’ll update you when the device is approved by the FDA and voila these objections mysteriously disappear ;)

You know a proper FDA approval takes years, right? Not the emergency do-whatever-you-want approval, a proper approval. By all means, please do post.

That’s for pharma trials. Medical devices flow through the CDRH.