KHOPOTSO: For Dr Wendy Orr, Director of the Transformation and Employment Equity Project at Wits University, in Johannesburg, two things are critical about the Rath clinical trial.

Dr WENDY ORR:

I think they have both been sacrificed ‘€“ ethics and scientific validity. And that’€™s deeply worrying because it means that people are being exposed to a process which is potentially damaging to them and which is not likely to give any benefit.

KHOPOTSO:   Last week, the chairperson of the research ethics committee of the University of Limpopo’€™s medical faculty, Medunsa campus, revealed that since August last year it has refused approval of a research proposal for a clinical study in HIV patients using Dr Rath’€™s nutrients. Among a list of concerns the committee raised is that the substances being tested are not registered with the Medicines Control Council. Quite simply, this means that the products in question are medicines. And when testing medicines for curative purposes certain rules need to be followed. Professor Wim du Plooy is the chairperson of the Medunsa campus’€™s research ethics committee.

Prof WIM DU PLOOY:

In any clinical study you must tell patients that they have alternatives. In other words, if I’€™m the researcher and I go to the patient and I say ‘€˜look, I have this wonderful compound that will help you’€™, then I must also tell that patient, ‘€˜look, if you’€™re not willing to take my compound, you can go to your clinic and they will be able to give you your antibiotics or antiviral or whatever medication’€™. I cannot withhold that option if that option is available’€¦ We are quite adamant about that.

KHOPOTSO: However, Professor du Plooy declines to say if that option was included in the research proposal using Rath’€™s products.

Prof WIM DU PLOOY:

No, I don’€™t want to divulge that information. I’€™m doing this not on purpose, but we also have to protect the intellectual property right of researchers.

KHOPOTSO: Dr Rath, however, makes no bones about the curative qualities of his multivitamins while his foundation claims in pamphlets that antiretrovirals are toxic.

An article on Rath’€™s website reads thus: ‘€œWe conducted a clinical pilot study in HIV positive patients with advanced AIDS. The goal of the study was to show that vitamins and other micronutrients alone reverse the course of AIDS, even in its advanced stage. Thus, it was essential that none of the patients had received any antiretroviral drugs before or during this nutritional programme’€.      

This kind of research, concurs Prof Thadeus Metz, an ethics expert at Wits University, is unethical practice.

Prof. THADEUS METZ:

If he’€™s trying to test what he thinks is a new therapy to cure or treat HIV/AIDS then, standard international best practice is to compare that new therapy with the best available therapy known at the time, which would be antiretroviral treatment’€¦ because for all we know right now ART is the most effective treatment and to take that away from people or not give it to them or not even inform them about it’€¦ that’€™s putting their lives at risk.

KHOPOTSO: His colleague, Dr Wendy Orr, adds that there are a number of actions that Rath had to take before he could run his trial.

Dr WENDY ORR:

First of all, the multivitamins should have been registered for that purpose with the Medicines Control Council’€¦ You cannot just take any medication and say ‘€˜I want to give this for AIDS’€™. You have to prove that there’€™s a chance that it will, indeed, be effective. Animal studies should have been done’€¦ His trial research proposal should then have gone for checking of its scientific validity’€¦ And then, finally, to an ethics committee for ethics approval. So, there are three processes that he should have gone through and he has done none of them.

KHOPOTSO: Since the necessary procedures before conducting a clinical trial were disregarded, it’€™s not clear what interest Dr Rath seeks to serve. For Dr Mark Sonderup, spokesperson of the South African Medical Association on HIV and AIDS, the trial makes no sense.

Dr MARK SONDERUP:

The problem is that no self-respecting publication or journal would publish your work for peer review when there’€™s been no research ethics approval of your protocol. So, I have no idea what he’€™s going to do with the outcomes of his work, suffice to say that what he is doing is completely unethical. And, in fact, it’€™s an abuse of people who clearly are desperate and he is victimising them. This is an untenable situation.            

E-mail Khopotso Bodibe