>>As Bruce pointed out, for treatment as a whole protocol (procedures and drugs) there are no regulations. A physician can experiment with procedures, including radiation, without regulations. Double blind studies are often not possible as both the patient and the physician knows e.g. whether they received radiation rather than medications.

Wow. Walter, it simply isn't correct that physicians can experiment freely as you describe. It is true that double blind trials may be impossible where it's obvious to patients and physicians that treatment was given. Double blind trials also are unethical if there's a body of evidence showing definite benefit for one of the options- you simply cannot withhold such treatment to prove a point and if during a trial significant benefit is shown for one of the arms, ethically you are supposed to terminate the trial.

For treatments not amenable to double blind you'd need to start with animal trials where possible (and face protest from activists who seem not to be considering the alternative) or in vitro tests if the cells are amenable to it, and then seek very serious ethical and peer audit before human trials even can be contemplated for your new treatment.

Then there's the patient who is not a sack of wheat on which practitioners can do as they please, at a minimum she is allowed to choose whether to be part of a trial and a physician who conducts experimental treatment without ethical committee approval or patient consent can expect to be struck off.

>>Things are different with drugs where placebo's are often practical. But not always. For example the use of smoking pot for the treatment of brain cancer: How do you envision to do a double blind study on that?

I assume you're referring to this advisory that was updated in December: http://www.cancer.gov/cancertopics/pdq/cam/cannabis/healthprofessional/page4

I see animal studies and in vitro human cell studies. So does this apply to humans? The problem with trying to "prove" it is that some patients have been undertaking their own trial for years and it may simply be impossible to devise any sort of meaningful research. ;-)