> I think the article touches upon this, but it's a little more nuanced than 'regulatory changes', because with this technique there is no time for informed consent, and doctors understandably want to avoid a situation carrying out this procedure on a patient who then subsequently died but could have survived were another treatment approach taken.
Sure, i don't argue on that. What I mean is that even if their first trial is widely successful (they save 50% of patients instead of the standard 7%), how long will it take and how many trials will be needed for the FDA to recognize this as a new clinical practice? It will be years - and in this period how many persons who could have been saved by this kind of procedure will die? That's what I was referring to.
If we could tell, just from a single trial, whether a particular drug was safe and effective, then it's true that the subsequent FDA trials would be a huge waste of time. Sadly, history has told us time and again that we can't.
>how long will it take and how many trials will be needed for the FDA to recognize this as a new clinical practice? It will be years - and in this period how many persons who could have been saved by this kind of procedure will die?
what prevents doctors from doing it today? Nothing. Like in that case with brain cooled by groceries, doctors seems to be doing it when they can. Other thing is mass-training of doctors for some procedure - that requires that procedure should be developed to some "packaged" level. This is what FDA approval is part of and seems to be a reasonable part.
Are you advocating that medical regulations NOT be based on scientific evidence? Or are you simply saying that the FDA's standards for new procedures are too conservative?
Sure, i don't argue on that. What I mean is that even if their first trial is widely successful (they save 50% of patients instead of the standard 7%), how long will it take and how many trials will be needed for the FDA to recognize this as a new clinical practice? It will be years - and in this period how many persons who could have been saved by this kind of procedure will die? That's what I was referring to.