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mmkhd | 5 years ago
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.)
achillesheels|5 years ago
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 ;)
ineedasername|5 years ago
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.
arcticbull|5 years ago
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.