South African Research Body Defends Ethics of AIDS Gel Project

[Guest guest]

[south African Parliament's portfolio committee on health questioned

the chief of South African Medical Research Council (MRC) on AIDS gel

research which was stopped early after 35 women developed HIV. It

would have been shocking and beyond belief, if the standing

committee on health and family welfare, under the chairmanship of Mr.

Amar Singh. M.P (general secretary Samajwadi Party) summons Indian

Council of Medical Research (ICMR) chief to explain, what happened to

the similar research in Chennai and Bangalore. Moderator]

South Africa: Research Body Head Defends Ethics of AIDS Gel Project

Tamar Kahn Cape Town

Medical Research Council (MRC) president Bewu yesterday

sought to reassure Parliament that the organisation's work on the

international Ushershell microbicide trial, which was stopped early

after 35 women developed HIV, had been conducted to the highest

scientific and ethical standards.

With one of the world's 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 don't 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 MRC's 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 department's 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 Parliament's 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.

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