This letter to The Times points out the folly of making regulations that do not require any demonstration that the product works. Can you imagine a regulation for television sets that required only that they do no harm, but did not specify that they should show a picture?
|From Professor D. Colquhoun, FRS
Sir, Congratulations on your report on the deficiencies found in complementary medicine practitioners (Body & Soul, January 10).
In the face of such evidence it is natural to ask for more effective regulation of this very profitable industry. But the question is quis custodiet ipsos custodes? This question has serious implications for the universities as well as for the public (and the industry).The House of Lords report and the Government’s response to it, pointed out that the first step was to find out whether the complementary treatment worked (better than a placebo). They recommended that the Department of Health should fund research on complementary medicine, the first priority being to find out whether each therapy worked. The problem is that you cannot regulate properly an area when it is not, in most cases, known whether the product being offered has no effect above that of wishful thinking.
This raises a serious question for universities, because it leads, naturally enough, to demands for better training. But how can a university run a course on a subject about which there is so little hard evidence? Tragically (for their own reputation), some of the new universities are running three-year BSc courses in such subjects as complementary therapies. I’m quite happy to believe that nice smells produce good placebo effects, but aromatherapy is not, by any stretch of the imagination, science, and in my view it is not honest to award Bachelor of Science degrees in it.The effect of such courses will be not to promote better regulation, but to give spurious respectability to an industry that, according to the Government, should (but does not) have, as its first priority, to find out what works and what doesn’t.
A. J. Clark Professor of Pharmacology,
Both the House of Lords report on Complementary and Alternative Medicine, and the Government’s response to it, state clearly “. . . we recommend that three important questions should be addressed in the following order:”. (1) does the treatment offer therapeutic benefits greater than placebo? (2) the treatment safe? (3) how does it compare, in medical outcome and cost-effectiveness, with other forms of treatment?
These recommendations seem admirable, but they have not been followed. The money has gone, almost (if not completely) to projects that address the second and third questions, before it has been established that the treatments have anything other than a placebo effect. This interesting case is debated in Debate: UK government funds CAM research (Focus on Alternative and Complementary Therapies , 8, 397-401 (DC’s bit, pp 400-401)).
[Get PDF of whole debate]
Both the House of Lords report and the Government response to it, state clearly “… we recommend that three important questions should be addressed in the following order: . . .
These aims seem admirable, but to what extent do the projects that have been funded match these recommendations?
The answer, sad to say, is that they do not seem to follow the recommended order of priorities at all.
None of the studies in the first initiative (Tovey, Corner and Shaw) appears to address the question that the recommendations specify should be done first. With the possible exception of White, none of those in the second phase (Shaw, Barry, Weatherley-}ones, White and MacPherson) do. (Dr White, like most other recipients, has declined to provide any information about his project so it is impossible to be sure.) None really addresses ,the second priority directly. The third recommendation is worded much more vaguely than the first two, but it is
The rationalisation given by some of the applicants for uncontrolled, or ‘pragmatic’ trials is that they are conducted under real clinical conditions and tell you what the patient actually thinks. It is quite true that, from the point of view of the patient, it does not matter in the least whether they feel better because of a placebo effect or because of a specific effect of the treatment. That is an important consideration but it is not the only one.
If the first priority had been addressed first (which it has not) it is quite possible that the outcome could be that the entire effect could be a placebo effect. Such a possibility has been envisaged by no less a luminary of the CAM world than Peter Fisher (ref 1). If that were to turn out to be the case it might matter little to the patient but it would matter a great deal to universities, which are under continual pressure from CAM people to run degree courses (though only a few have acquiesced).
If the whole effect were placebo, it follows that the ‘principles’ of homoeopathy, reflexology, etc. are mere mambo jumbo and so not appropriate for teaching in universities (or, indeed, anywhere else). The question of courses and ‘training’ cannot be considered until the first question is answered because, until then, we do not know if there is anything real to train people about. That is why it is the first priority. There would however, be a dilemma for clinical practice. The placebo effect does appear to be useful, so the question would then become how best to produce a good. placebo effect without too much intellectual dishonesty. Perhaps that is a question that deserves more research.
The fact of the matter is that the Department of Health has ended up spending £1.3 million of public money in a way that directly contravenes the recommendations of the House of Lords and of the government (with one possible exception). They claim that this happened because very few applications were received that addressed the government’s first priority. That alone says something about the extent to which the CAM world is interested in tests against placebo hardly surprising since a negative result would destroy their livelihood. But, arguably, if few applications were received that addressed the first priority, then the funding should have been postponed until appropriate applications were forthcoming. The reason that this did not happen is, I fear, only too obvious. The judging panel was dominated by CAM people who clearly share the lack of interest shown by the rest of the CAM community in answering the most important question first. If such research must be done, because of public demand for it, it should have been organised by the Medical Research Council using the same criteria they would use for any other treatment.
1 Fisher P, Scott DL. A randomized controlled trial