>>>>Tamar,
>>>>
>>>>There is a clear difference between regulations and studies. Studies happen after a certain procedure has been coined for treatment of a certain issue and already have been applied to significant number of patients. In-vitro and animal trails are not very useful and double blind peer reviews neither. The regulations that are in place for FDA approval of drugs are (largely?) not applicable to these kind of procedures.
>>>>
>>>
>>>I don't think that's right. I don't think a doctor can just try a new radiation protocol because he feels like it. At least not in any reputable hospital. At a minimum, the hospital's Institutional Review Board will have to approve it.
>>
>>It would and should be the norm that any new procedure should be discussed and approved within a professional committee. But that does not mean that those procedures are regulated in the same strict, nation wide manner as is applicable with drugs. Again, if a physician decides to do a head transplantation there really is nothing in the law that requires an approval process with in-vitro, double blind trails and animal results with in the end approval from the FDA.
>
>As I said, an Institutional Review Board isn't likely to approve it.

You'd be surprised of what gets through that. See
http://www.newscientist.com/article/mg22530103.700-first-human-head-transplant-could-happen-in-two-years.html#.VTENFZM9rDY

>Beyond that, in this country, insurance isn't likely to pay for it, and in other countries with national health systems, I presume payment is also an issue.

Well, just like 'most' of the procedures in the US ;-) as with drugs.

Walter,