>>>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.

Perhaps the confusion is in the word treatment, which in this context includes doing procedures, following protocol and giving drugs. we also have to acknowledge that rules might be different from country to country.

As long as it does not have to do with drugs, you do not need clinical trials for procedures using different techniques. Things are different again for equipment which might need e.g. FDA approval or CE certification. That is where it gets a bit fuzzy to me. As you described before, if a patient can be treated with a new technique, not done before there aren't any regulations that I know off. A friends daughter was saved as a infant using a new cardiac surgery technique that was never tried before. It simply was a matter of life and death. That is also true for e.g. stereotactic radiation techniques which were just applied without any regulations. Many breakthroughs in medical science were just achieved NOT to go through any such extensive clinical trails. When lives are at stake you often do not have much choice.

>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.

Again, this is largely related when treatments are largely related to drugs. For procedures there isn't such thing AFAIK.

>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.

There are still rules that patients have to sign consent or otherwise have to agree with the proposed treatment.

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

Not really, just taking that as an example that double blind studies are not always possible.

>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. ;-)

That always is the problem, even in a regulated environment. Results are often related to the skills of the surgeon and population of your patients.

But again it comes down to the word "Regulated". It does not mean that a procedures are not being done in peer reviews to get a certain procedure accepted in medical science. It also does not mean that a physician can do whatever they want... it probably needs to be approved in a committee. But take for example the news that one physician wants to do a head transplantation for a Russian IT consultant. What kind of regulations are in place for that?

Walter,

Take for example IVF. There was no form of regulation when louise brown was born. At the end of the 70-ties and 80-ties, everyone was experimenting with human embryos without any regulation. The regulation came later but still left plenty of room for new procedures and techniques, which of course are still happening today.