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From: werner@aecom.UUCP (Craig Werner)
Newsgroups: net.med
Subject: Re: Double Blind Studies.
Message-ID: <1686@aecom.UUCP>
Date: Sun, 26-May-85 21:59:48 EDT
Article-I.D.: aecom.1686
Posted: Sun May 26 21:59:48 1985
Date-Received: Wed, 29-May-85 02:25:50 EDT
Distribution: na
Organization: Albert Einstein Coll. of Med., NY
Lines: 48

> Will Martin asks:
> 
> If you are testing a truly effective medication, say for some serious
> disease or condition, and are conducting a blind or double-blind test
> where some participants get placebos and some the medication, and a
> number of the control group die because they got only placebos, while
> all the test subjects survive because this experimental medication was
> really effective, have you not violated the Hippocratic oath (and also
> laid yourself open for damages, no matter what you had the participants 
> sign), by denying this (admittedly experimental) medication to people
> who could possibly have been saved by it?

	This is a good point, and the paradox caused by it has in fact
really caused the demise of true double-blind studies. It is no longer
ethical to test a drug that has a known positive effect against a true
placebo, only against another drug and/or therapy.

	One example will suffice.  In the Multi-Risk F(?) Interventional
Trial (known affectionately as MR-FIT), a study was done to see if 
reducing high blood pressure would actually reduce death rate from
Stroke and/or Heart Attack.  Instead of dividing the group into treatment
and no-treatment, the study was divided into those who received intensive,
aggressive, regular, and free care, and those who were referred to their
normal doctor.
	This is how the dilemma Will Martin posed was circumvented in this
case:
	Just to go on about MRFIT itself:
	The data is still coming in, but it is clear that:
	1) Both groups experienced a drop in death rate as compared to the
US as a whole.
	2) The drop was not much greater in the Experimental group than in
the Referred Group. (This could just be an indication that people who went
to their physicians might have actually received the same treatment)
	3) The drop in death rate also occurred in causes of death totally
unrelated (at least so far) with high blood pressure.

	Incidentally, this study has been misused by Phillip-Morris in their
Anti-anti-smoking campaigns. They cite MRFIT as 'proof' that smoking isn't
really all that bad.  (The reason is that the experimental group in MRFIT
had to quit smoking if they did, but a look at the data will probably show
that a good percentage of the control did also -- and Phillip Morris doesn't
mention that fact.

	
-- 
				Craig Werner
				!philabs!aecom!werner
		"The world is just a straight man for you sometimes"