Don't damage our health, Mrs Z

The audacious decision of health minister Dr Nkosazana Zuma to abolish the Medicines Control Council, the public’s watchdog for medicines, has taken the scientific community's breath away. Reasons given for the closure by the investigating task team include poor communications and “conflict of interests”. In truth it is more likely that the government was furious with the council for blocking testing of the so-called Aids drug, Virodene, on humans because of fears about its toxicity. Virodene, which contains an industrial solvent, kills HIV in vitro but then so do other substances — bleach, for instance.

The Democratic Party alleges that the ANC stood to gain financially from the commercial manufacture of the drug, though this has been strenuously denied. Hitting back in a lengthy article that appeared in Sunday newspapers on March 8, deputy president Thabo Mbeki accused the MCC of denying the possibility of a mercy treatment to Aids patients. He concluded: “The cruel games of those who do not care should not be allowed to set the agenda.”

While we await the Public Protector’s report on the DP allegations, no doubt the testing of Virodene on humans will get the green light. No one will object to this if the correct procedures — expressly designed by the international scientific community to protect the public from useless and/or harmful drugs — are followed. Drugs often have harmful as well as beneficial effects and these need to be carefully balanced and assessed. For the benefit of Mrs Zuma and her future new medicines regulators, Refocus sets out those procedures here:

First, a protocol, specifying exactly how the drug in question is to be tested, must be approved by a medical ethics committee. This is to ensure that subjects enter the trial willingly and understanding what it involves, including any possible risks. After approval is secured, trials can begin and these are usually done in three stages.

In Phase I a small sample of healthy people is given the drug to ensure that there are no immediate adverse side effects.

If the results are satisfactory, Phase II trials are conducted on patients to see if they respond to the drug and further safety tests are also carried out. If the drug appears to be safe and if there is reason to believe that it might be effective, it goes to Phase III “double blind” trials.

In Phase III a much larger number of patients (from several hundred to a thousand) receive the drug and a similar number — the control group — are given a placebo. Neither the staff administering the drug, nor the clinicians examining people for disease, know which patients get which. When the trial has run for a year or more, the code is broken and the data are analysed.

The testing of Virodene so far has fallen somewhat short of these rigorous standards. It seems that a trial was done on 11 people, without ethical approval, of whom five were lost to follow-up. Even if a drug was highly effective, a trial involving six people with no control group would not be able to establish its efficacy.

Without the MCC, can the government assure us that desperate Aids patients will be protected from another Kemron-type scandal? This “cruel game” was played in Kenya in 1988, when the Kenyan Medical Research Institute announced that a drug called Kemron was a cure for Aids. It was not initially subjected to proper clinical trials but very quickly became available on the streets of Nairobi. Ten years later we know that Kemron has no therapeutic value in the treatment of HIV infection, and that tens of thousands of people in East Africa and elsewhere had their hopes raised and cruelly dashed. Oh yes, and the people who manufactured the drug made a fortune.