Jeremy Sherr and the ethics of CAM

As a geologist, I don't tend to have to worry about the ethics of research involving humans; I usually only deal with rocks. But in medical research, ethics are crucially important. In CAM research, the ethical dimension often seems to be lacking, which brings me to the case of Jeremy Sherr.

Jeremy Sherr is a prominent homeopath who claims to treat AIDS patients in Tanzania with homeopathy, based on the usual poor quality anecdotal evidence and wishful thinking. He recently caused a stir in the badscience blogosphere, with a blog entry in which he mused about conducting a trial of homeopathy in AIDS patients. The mooted trial is transparently unethical, as pointed out by a number of sceptical bloggers (notably in the comments on Sherr's blog, and at Gimpy's blog, here and here, and The Lay Scientist, here and here), and as we'll see below. Now, Sherr likes to edit his blogposts and delete comments, but let's have a look at what Sherr had to say about the trial.

I am happy to go for a simple trial initially, treating AIDS patients who are not taking ARVs. There is no shortage of patinets who, although they have been offered ARVs, have chosen not to take them, usually because of the serious and debilitating side effects. There are plenty of statistics on ARV treatment and patients with no treatment at all that we can compare to.

Why is this unethical? I would say for three reasons. Firstly, it is a general principle of medical ethics that patients in a clinical trial should not be denied proven treatments for their condition. Clearly, in this trial AIDS patients would be denied ARVs. Sherr seems to think that this is OK because his patients have decided not to take ARVs themselves, but this is, I think, irrelevant. You would still be running a trial in which the subjects are not receiving the best possible standard of care. The issue of informed consent is again critical here; patients would need to be informed that not taking ARVs could be severely damaging to their health.

Secondly, the trial as mooted will not provide any useful information, because there is no control group. Whatever happens in the trial, it is impossible to say that it happened because of homeopathy, rather than sources of bias in the trial design. Since the trial could not provide any usable information, it would be unethical.

Thirdly, I would say we have enough evidence and knowledge about homeopathy to say that it is not going to cure AIDS. Given that there is no likelihood of a true positve result, it is unethical to involve patients in a clinical trial. Informed consent comes into play again here: patients in the trial ought to be told that the current evidence shows that there's essentially no chance of homeopathy having any beneficial effects beyond placebo.

Sherr says, in the recent blog post in which he calls the waaaaambulance over the criticism he has received, that "Any research I may undertake will be subject to rigorous ethical review of the highest standard". Hopefully that will in fact happen, in which case the mooted trial will surely not go ahead. What is disturbing is that Sherr has stated in the past, referring to research protocols and ethics review, that "You have to find willing partners and get a protocol through an ethics committee, and you need to talk their language. I hope it will work but if not, I will just go and do it on a small scale myself - I am determined to do that". This is the most telling comment, I think: it makes it clear that Sherr is not really interested in medical ethics, except as a hoop he must reluctantly jump through in order to experiment on terminally ill patients. And if he can't get ethics approval, he'll just do it anyway.

So much for Sherr. Disturbingly, however, he seems not to be anomalous in CAM circles in his total lack of any sense of ethics. A review of a book "Complementary and Alternative Medicine: Ethics, the Patient, and the Physician” has just been posted on the Science Based Medicine blog. The reviewer comments that "We do not read a word about how to approach a patient who has suffered damage due to CAM, or how to approach those who have stopped their regular treatment" [emphasis mine]. One would have thought that this would be a key issue for any book purporting to address ethics in CAM.

As one of the commenters to the Science Based Medicine piece astutely points out, CAM is a "deprofessionalization phenomenon". Researchers in the field of CAM seem to have no idea about research ethics, and no idea about the linked issue of how to conduct good research. If a text on ethics in CAM is so careless of these important ethical questions, how can we expect CAM practitioners to be any more careful?

UPDATE: There is now an excellent and comprehensive post on the Sherr saga at Respectful Insolence...

Yet one more radically pointless homeopathy study

Generally, when the efficacy of a medical intervention is being assessed, you expect the quality of the trials and evidence available to increase through time. You might start out with uncontrolled case reports and observational studies, proceed through small-scale pilot studies, to large randomised placebo-controlled trials, and finally to systematic reviews and meta-analyses of the literature.

In CAM research this pattern is often not followed. Once systematic reviews and meta-analyses start to show that there is no evidence that the CAM treatment works, more small trials of poor methodology are conducted, many of which inevitably have (spurious) positive results. This allows CAM advocates to claim that there is lots of evidence in favour of their intervention, because they don't bother to account for study size and quality.

There is a fine example of this CAM tradition in the latest issue of Homeopathy. A systematic review, published in 2006, of homeopathy for treatment of allergic rhinitis concluded that "Some positive results were described in rhinitis with homeopathy in good-quality trials, but an equal number of negative studies counterbalance the positive ones. Therefore it is not possible to provide evidence-based recommendations for the use of homeopathy to treat allergic rhinitis, and further randomized controlled trials are needed". Well, perhaps: some would argue that the prior probability (close to nil) and currently existing evidence are enough to conclude that homeopathy does not work for allergic rhinitis (or, indeed, anything else). Be that as it may, it should be clear that the only useful new evidence would come from large and well-conducted RCTs. So what do Maria Goossens and a football team of colleagues do in the latest issue of Homeopathy? Why, publish a "prospective, open, non-comparative study" on homeopathy and allergic rhinitis, of course.

The methodology of the study consists of "treating" some patients suffering symptoms of allergic rhinitis with homeopathy, and getting them to fill in a quality of life questionaire at the start of the study, and after three weeks and four weeks. The physicians involved also assessed the severity of symptoms at baseline, three weeks, and four weeks. Unsurprisingly, the study found that people felt better with homeopathic treatment. But the methodological problems with this study are straightforward to point out. There is no control group. As a result, there can be no randomisation or blinding. Don't take my word for it; here's what the authors say in the discussion of their paper:

We did not distinguish between intermittent and persistent allergic rhinitis. All patients with intermittent allergic rhinitis (symptoms present less than four consecutive weeks a year) will be better after four weeks without any treatment. Patients who consult a homeopathic physician for allergic rhinitis usually have been suffering for a long time and from severe symptoms as the high level of the RQLQ score at baseline indicates. This study cannot be conclusive because there is no control group. Neither the physician, nor the patient was blinded. We cannot conclude that the degree of certainty of the physician about the appropriateness of the homeopathic prescription of a homeopathic remedy and the physician’s impression whether he had sufficient information about the patient’s condition influenced the outcome...it is not possible to draw a conclusion on the effect of the homeopathic treatment. This would require an RCT. To evaluate the effect of homeopathic treatment for allergic rhinitis an RCT should be performed.

So there you have it. The study cannot come to any useful conclusions. And, in the introduction to the paper, the authors write "This study was originally considered as a preliminary to a Randomized Clinical Trial (RCT) comparing standard conventional therapy with homeopathy (non-inferiority study). The RCT was never performed because sponsorship was withdrawn".

OK, that's life. Sometimes planned research funding fails to come off. These things happen. But why then publish the pilot study? Methodologically, it is useless, and it could never have added anything to the previously existing evidence from RCTs and systematic reviews. This study would never have been published anywhere other than a CAM journal, where scientific usefulness can take a back seat to an ideological desire to publish any evidence that looks as though it is in favour of homeopathy, no matter how methodologically weak it is, and in defiance of the higher level evidence that already exists.

Well, no-one is going to die from allergic rhinitis, so how much does it matter? The problem is that homeopaths don't stop at self-limiting conditions like hayfever. Some insist that homeopathy is a complete system of medicine and it can cure anything, including AIDS and malaria. Ben Goldacre's miniblog points to Jeremy Sherr's blog, for example, where Sherr is preparing to begin an unethical experiment on AIDS sufferers. This is a long road of madness, to be sure, but it begins where people believe they can cure hayfever through the use of magic sugar pills.