Friday, 2 January 2009

Two meetings


The first meeting was with professor Zakaria H Mbwambo at the Institute of Traditional Medicine, Muhimbili University College of Health
Sciences. I had spoken to Doctor Mbwambo one year previously regarding the possibility of research into the homoeopathic treatment of AIDS, and he was very opening and encouraging. We now had a follow up meeting in the presence of professor Flora. Professor Flora is a learned and charming lady, and is a professor of anatomy and physiology at a nearby university, as well as a practicing homoeopath. She is going to lend her clinic to the trial, which is great news. We schedule further meetings, but it is clear I will have to raise some more funds to make this happen. The university can only give seed money. The most important thing for me is to get initial lab reports and statistics treating a small number of AIDS patients. I can then use this to push for funds and larger trials.

When I was in South Africa 5 years ago, we had designed a very complex trial together with the Nelson Mandela hospital in Durban. This trial had three arms; patients with homoeopathy and without ARV treatment, patients with homoeopathy and ARV treatment, and patients with ARVs alone (Placebo treatment is considered unethical in AIDS). It was a very comprehensive and well designed trial and it covered all the bases. And once the dean of the hospital resigned to go into the private sector, it was also a very dead trial. So I am happy to go for a simple trial initially, with one arm of AIDS patients with homoeopathy and no ARV. There are plenty of statistics on ARV treatment and patients with no treatment at all that we can compare to. If we can prove that homoeopathy has any positive effect at all, we can move on to bigger and better things.


The second meeting was at the Kibosho hospital near Moshi. Father Patrick organized a talk on homoeopathy to the staff. Sigsbert and I arrived thinking we would be talking to one or two doctors, but it turned out that the whole staff of about 40 doctors and nurses were eagerly waiting to hear about homoeopathy. All were dressed in white uniforms, and as always in Tanzania were very polite and courteous. When they enter the room they bow or curtsy and introduce themselves. Sigs explained about the Tanzanian law that support homoeopathy and other traditional medicines; Traditional and Alternative Medicine Act No. 23 of 2002. You can read it on

http://www.lrct.or.tz/documents/23-2002_The%20Traditional%20and%20Alternative%20Medicines%20Act,%202002.pdf

Sigs has been the main force behind this law, and he made sure that it was done properly and safeguards homoeopathy and just about every other major alternative medicine. It is a major achievement. This law is very important, because without legal backing from the government nobody wants to know. But once it is clear that we have government backing the staff is very interested. And once Sigs tells them about his clinic treating up to 100,000 patients a year, mostly for malaria, they are also very impressed.

I give a short talk on the principles of homeopathy. To my surprise everyone understands English, so I don't need translation. I hammer it home, short and sweet. After 29 years, I know how to do this quite well, and it hits the mark. The staff ask various questions, always politely and respectfully, and occasionally with the usual skeptical undertones. We set them straight.

After the talk many come over for a chat. It turns out that some of the nurses have actually been to Sigs’ clinic, which is a long way away, to treat their malaria. They all did well so they are believers. In fact, wherever we go we seem to be meeting patients who have been treated at the clinic.

Our aim is to set up a malaria trial here at the hospital, as well as an AIDS clinic. It seems we are on the way.

16 comments:

Liz said...

Dear Jeremy:

I am following your progress and all that you are accomplishing with much interest, as well as thinking about what I can do to support you in your mission from here in the U.S. Keep up the good work; you are doing a fantastic job.

All the best,
Liz Dickey

ben goldacre said...

"I am happy to go for a simple trial initially, with one arm of AIDS patients with homoeopathy and no ARV. There are plenty of statistics on ARV treatment and patients with no treatment at all that we can compare to."

this is a frighteningly poor quality research plan with no adequate control group to compare against. many people hold the view that it is unethical to perform incompetent research on human subjects, largely on grounds of wasted opportunity, and the issues around deceiving patients that they are participating in a meaningful research exercise.

performing a fair test of homeopathy is no more expensive than performing a flawed one. your plan makes me very sad.

GingerAle said...

I second ben goldacre's comments. You need to reconsider your ethical standards.

theholyllama said...

"Placebo treatment is considered unethical in AIDS"

"I am happy to go for a simple trial initially, with one arm of AIDS patients with homoeopathy and no ARV"

My irony meter has just broken.

jonhw said...

"Placebo treatment is considered unethical in AIDS"

And a trial of an implausible remedy that lacks good evidence of any benefit over placebo - and which is being given to patients who are not receiving ARV treatment - is ethical? Not to mention that the poor trial design means that you will not generate useful results - so you have the added ethical problem of wasting the time and energy of patients (and of the medics etc. who are working on the trial).

If you want to conduct a trial, wouldn't it be more ethical to use e.g. patients who are receiving ARV in a proper RCT? You could provide one arm with 'real' homoeopathic pills, and the second arm with 'placebo' homoeopathic pills.

Of course, there are still issues around informed consent etc. Are you going to make clear to prospective trial subjects that a) there is not good evidence that homoeopathy works any better than placebo and b) there is no scientifically plausible explanation for why homoeopathy might work better than placebo? And I trust that you will make very clear that homoeopathy is in no way an alternative to effective treatments such as ARV, or to lifestyle measures such as adequate nutrition.

phayes said...

“Sigs has been the main force behind this law, and he made sure that it was done properly and safeguards homoeopathy and just about every other major alternative medicine. It is a major achievement.”

Who cares about the ethics or quality of the research? First, do no harm to the evil lunacy that is homeopathy.

Utterly, outrageously, despicable.

William said...

The other posters are correct.

A substantial portion of the medical world believes, based on quite a lot of studies, that homeopathic remedies are placebos. So you at least have to acknowledge that as a possibility. In which case, your experiment is just as unethical as treating with known placebos.

For a human experiment on a fatal, transmissible disease to be even vaguely responsible, you must have a) substantial evidence that your remedy could be at least as good as the current proven treatments, and b) no other avenue to test your remedy. That means exhausting all possible lab and animal studies. Have you done that?

Because what it sounds to me like you are doing is testing an unproven cure (in a way that will not generate useful data) on poor and uneducated people whom, if you are wrong, will die after infect others who will also die.

I'm not a lawyer, but I believe that in the west, that would be criminal behavior.

Beacon Schuler said...

This is painfully absurd. Surely before you run a trial of this nature you should first run a trial where one arm is given conventional treatment plus placebo against an arm that is given conventional treatment plus homoeopathic remedies? Wouldn't that be more ethical than not supplying participants with a proven medicine based on a plausible mechanism?

Anonymous said...

Conducting medical research on patients with a lethal disease while denying them access to a well-proven and easily provided treatment? Swap HIV and ARVs for syphilis and penicillin, and it'll become painfully clear that what you're proposing is no trial, but instead another Tuskegee (google it).

Hugh Parker said...

Some of the comments above are quite harsh, but it seems clear that, as far as you're concerned, your work is legitimate, ethical, valid and scientific. To clear this up, could you say which legitimate, ethical, peer-reviewed scientific journal your research will be published in?

RJT said...

Why do you want to conduct poor quality trials in Africa that would never get ethics clearance in Europe? Is it
a) you don't know any better.
b) you know a double blind randomised control trial has only a 5% chance of giving the result you want
c) you want to try to beat Mbeki's tally of 300000 unnecessary deaths

The Biologista said...

Serious ethical issues in this trial, no question. A non-ARV group? Seriously? This is extremely disturbing.

gimpyblog said...

Hi,

I have to echo the previous concerns expressed by Ben Goldacre and others. I wrote about Mr Sherr's intentions and his cavalier attitude to ethics over a year ago on my blog and at the time emailed to ask him for comment. He did not reply, I also contacted the Society of Homeopaths as Mr Sherr holds a Fellowship with them and they told me that Fellows were not bound by their rules.

Anonymous said...

The sad thing is, that it would be perfectly possible to do one of a couple of trials that might even show a benefit of homoeopathy:

*** Trial 1: Randomised controlled trial of pre-ARV homeopathy ***

Study population: HIV+, treatment-naive people with a CD4 >350.

Comparison: Three arms. Homoepathy + CD4 & viral load monitoring vs Placebo + CD4 & viral load monitoring vs CD4 & viral load monitoring alone.

Endpoint: CD4 falls below 350, or followed up for n years (where n is defined before the study starts based on a power calculation).

Outcomes: Viral load, CD4 count, loss to follow-up

Justification: homoeopathy might either (a) have direct clinical benefits for controlling HIV infection, which could be resolved through a comparison of CD4 and viral load changes with the placebo group, or simply receiving something might encourage follow-up, which could be resolved through a comparison with the homoeopathy and placebo groups with the monitoring-only group. If the latter, this could be a serious benefit - many people don't come back for further monitoring if once told that they don't need anything "at the present time".

*** Trial 2: RCT of post-ARV homeopathy ***

As Trial 1, but looking at whether there is any benefit to adding homoeopathy or placebo to the standard ARV regimen in patients starting on ARVs. Same outcomes, plus mortality; endpoint n years or death. If you want to be fancy, you could even combine the two trials quite easily.

Jamie McPherson said...

Perhaps you should consider what you would think about a pharmaceutical company who conducted one armed trials of a therapy that has no evidence of efficacy, on AIDS sufferers, in the third world to escape ethics committees. I don't think you would be very complimentary about it, and for good reason. I emplore you to reconsider your trial design as people's lives undoubtedly depend on it, if you ever manage to go ahead with the trial.

Le Canard Noir said...

Jeremy - I think it might be worth pointing out that it would be no exaggeration to say that you are one of the main reasons why there are such intense attacks against homeopathy in the UK. The complete and utter lack of awareness of what you are doing, combined with the dishonesty and silence of organisations like the Society of Homeopaths makes the homeopathic trade a dangerous menace.

Were homeopaths to stick to what it is reasonable to assume that you could safely and competently achieve then there would be no quarrel. But your actions here show that homeopathy is not just pseudoscience, but a dangerous and unforgivable delusion.