Research body head defends ethics of AIDS gel project

With one of the worlds worst HIV epidemics, SA is at the forefront of international efforts to develop safe and effective microbicides, gels or creams that women can use to help reduce the risk of catching the virus from infected male partners.

The Ushershell trial was in its final stages but was halted after interim analysis of the data showed the cellulose sulphate gel might raise the risk of getting infected with HIV. 

The news triggered widespread media coverage, with one weekend newspaper describing the South African trial participants as guinea pigs. 

The MRC had consequently stepped up its efforts to inform the public that the Ushershell trial had been conducted to the highest international standards, said MBewu. 

There is a misconception that trials are undertaken to satisfy scientific curiosity or for money. People dont realise they should be done in SA, he said. Research should ideally include the population groups who would eventually use the products.

MBewu urged MPs to support the MRCs call for greater scrutiny of all clinical trials conducted in SA. Earlier this month the MRC suggested that the health department develop a clinical trials inspectorate working under the auspices of the National Health Research Ethics Committee. 

Although proposals to conduct clinical trials were carefully vetted by ethics committees at universities, and by the Medicines Control Council, there was little subsequent oversight by an independent authority, he said. 

However, the health departments new clinical trials registry was an important step towards providing the public with more information on the variety of research projects with human subjects, he said. The register, available on the internet, lists 159 clinical trials.

Two independent organisations oversaw the Ushershell research: the US-based health organisation Conrad was running trial sites in SA, Uganda, Benin and India while Family Health International ran two trial sites in Nigeria. Women were given a microbicide or a dummy gel, as well as condoms and regular counselling about safe sex neither they nor the researchers knew whether they were getting a placebo or the real product. A total of 1333 women were recruited by the Conrad trial, of whom 604 women were from SA 20 of the South African women had developed HIV, but researchers did not yet know whether or not they had used the microbicide, said MBewu. 

Eleven previous trials of the Ushershell microbicide had found no adverse effects, so researchers were puzzled as to why so many women in the trial had got HIV, he said. Scientists were unlikely to have an explanation for several more months, he said. 

Members of Parliaments portfolio committee on health questioned mBewu closely on the methods used to recruit participants for the Ushershell microbicide and whether the women had fully understood the risks and benefits involved in the research. 

MBewu said women were paid R150 for each visit to the research centre in Durban, but said this was not a perverse incentive as government policy required researchers to provide trial participants with a basic stipend to cover transport, lunch and lost income.