Prof WIM DU PLOOY: No, we have not approved it.

KHOPOTSO: When did you receive the application?

Prof WIM DU PLOOY: If my memory serves me correct, round about August last year.

KHOPOTSO: Why have you not approved the application?

Prof WIM DU PLOOY: Normally, when an application is submitted we go through a whole process of review and peer review of the application and then, some of the enquiries or the concerns must be addressed by the researchers before we approve it. And up to now the concerns that we had have not been done yet.

KHOPOTSO: What concerns did you have? What is it that you required?

Prof WIM DU PLOOY: I cannot divulge the exact detail because the protocol is always regarded as confidential. So, I cannot tell you what is still outstanding.

KHOPOTSO: Professor du Plooy did, however, confirm this one important fact.

Prof WIM DU PLOOY: In this case, MCC approval has not been submitted to us yet.   We normally look out for, in the protocol, whether it should get MCC approval or not. And this one should get MCC approval.

KHOPOTSO: The admission ends lengthy speculation as to who could have approved the Rath Foundation trial that Dr Rath refers to in an article in his website if the Medicines Control Council didn’€™t. In the article, titled: ‘€œClinical Proof: Micronutrients Reverse the Course of AIDS!’€ Rath writes that his Foundation ‘€œconducted a clinical pilot study (in Khayelitsha, a township in the Western Cape) in HIV positive patients with advanced AIDS’€. The fact that Rath went ahead and conducted a clinical pilot study without approval of the MCC or Medunsa, the academic institution through which he had sought approval of his trial, says Professor du Plooy, is an unethical approach to a clinical research study.

Prof WIM DU PLOOY: No. Researchers are not allowed to start, even with a pilot study, without research ethics approval. They are not allowed to start. There are quite a number of regulations that we have to follow.

The latest one is what is called the ‘€œEthics in Health Research Principles, Structures and Processes’€™. This was published this year. It’€™s also part of the Health Act. There are the Helsinki Declarations. We have what is called the ‘€œGood Clinical Practice in Research Trials, and so on’€. It’€™s an unethical trial.

KHOPOTSO: What ethics are we talking about here that they are flouting?

Prof WIM DU PLOOY: The main purpose of a research ethics committee is to make sure that the rights and the welfare of the participants are protected. If they do not have   approval it means that there is no way that we can at least try and protect that dignity, welfare, and rights of the participants’€¦ I can just give you an example and this does not mean that what I’€™ve said now is specific for this Rath protocol, as we call it now. Issues that we look at are, for example, if a clinical trial is done: What harms are there? Are there benefits to the patients? What will happen once they have conducted the study? We look at things like the informed consent. Will the patients understand what they are consenting to? Is it in the proper language? We must ensure that the patients understand that they are taking part in research (1) and (2) that there might not be even any benefits for them in it.    

KHOPOTSO: The application for approval ‘€“ submitted with the title: ‘€œClinical Pilot study in Immunocompromised Patients Including HIV Positive Individuals with Dr Rath Cellular Programme’€ – has as its Principal Investigator one of Medunsa’€™s own employees, Professor Sam Mhlongo, head of the Department of Family Medicine. Mhlongo is well-known for his unconventional views on HIV and AIDS. It’€™s perhaps unsettling for Prof du Plooy and Medunsa’€™s research ethics committee that a pilot study involving a member of their own has been conducted without the necessary approval.

Prof WIM DU PLOOY: Because one of the researchers works at Medunsa, we then expect that researcher to get ethics approval from us if he is going to use the name of the university, regardless (of) where that protocol is carried out. If he wants to go to Alaska and do it there we must still give approval if he works for the university.

KHOPOTSO: Any direction from the MCC about this?

Prof WIM DU PLOOY: All I heard from them is that they want to investigate it, that’€™s all. They haven’€™t asked me for a report, nothing’€¦

KHOPOTSO: You haven’€™t personally spoken to them or reported anything to them?

Prof WIM DU PLOOY: It was just through a e-mail that they intend to investigate the matter. Not even with an official letter to say that they will or that they intend to investigate the matter.

KHOPOTSO: The Medicines Control Council confirmed in April that it is investigating the activities of Dr Rath and his foundation.

When contacted for comment this week, registrar of the MCC Dr Humphrey Zokufa, failed to say what form the investigation was taking. All he could say was that ‘€œa final report will be ready in six weeks’€™ time’€. Further queries into the approval of the Rath nutrients’€™ trial have revealed that no other South African medical universities or private research ethical committees, have ever received an application from the Rath Foundation nor gave any approval for the trial to take place.    

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