Ethics of Zambian ‘Microbicides research’ questioned

Talent Ng’andwe
16 February, 2010
As debate intensifies on the failed microbicides research in Mazabuka, southern Zambia, the scientific community should come out and declare a moratorium on the allegedly unethical behavior during failed clinical trial of the anti-AIDS virus gel, microbicide PRO 2000.

The reason given by the University of Zambia Biomedical Research Ethics Committee (Unzarec) chairperson James Munthali to clarify that the 46 women in Mazabuka who participated in the research on Microbicide Development Programme trial 301 were not infected with HIV/AIDS as a result of the research, leaves much to be desired.

Munthali puts it in his statement that there was no cause to believe that the 46 women out of the 1,332 who were enrolled during the research were infected because of their participation in the research and his position was in line with results obtained from the same research conducted in South Africa , Tanzania and Uganda .

“We will continue to ensure that the lives and health of Zambians participating in research are safeguarded through vigorous review and monitoring of any research to be conducted in Zambia,”Muntali said.

He further said after all ethical requirements, researchers were granted approval on April 5, 2005 to start the research and the evolution of the study was documented.

But Zambian scientist should develop standards to guide research on microbicides — substances that kill or block the HIV virus?

The aim of the guidelines would be to prevent unethical clinical trials and to minimise health risks to women taking part in them.

The Southern African Aids Trust in one of its reports puts it that, throughout Africa , there are concerns that women participating in clinical trials risk becoming infected with HIV during the testing of microbicides if they have sex with men who have the virus.

Little support is given to women participating in the trials, and few attempts are made to protect their rights in the event of them suffering side-effects.

The transparency and accountability of researchers running clinical trials should also be subjected to scrutiny.

Fears grow that the low literacy level of many women in rural areas of Africa countries means they would have difficulty understanding and information provided and the contract they are asked to sign.

Sisonke Msimang, a South African HIV/AIDS and gender activist, says that an effective microbicide would not help tackle HIV/AIDS on its own. Women would also need to be consulted about how they would use such drugs, to develop a practical product that is safe, effective and affordable.

Researchers will need to investigate ways to enable women to discuss with their partners currently taboo topics such as sexuality and contraception, so that the subject of microbicides is easier to broach, said Msimang.

The importance of tackling the socio-economic difficulties facing African women was highlighted in the 2004 report from the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The agency states that almost half of the 37.2 million adults who have HIV worldwide are women — a stark contrast from the start of the AIDS epidemic when most infected individuals were men. According the report, in sub-Saharan Africa almost 60 per cent (13.3 million) of adults with HIV are women.

Women are biologically more susceptible to the virus than men, but they also have less power than men over the measures they are able to take to prevent infection, says the UNAIDS report.

As UNAIDS's deputy director Kathleen Cravero explained at one of her press conferences in London that, cultural norms and taboos prevent women from asking their husbands or sexual partners to use condoms or to take HIV tests.

In response to the UNAIDS report, Zeda Rosenberg of the International Partnership for Microbicides called on the world's governments to boost investment in microbicide research and development. She added that "the pharmaceutical industry must also continue to make new antiviral agents available for testing as microbicides".

Funding is crucial, Rosenburg points out. "With an additional global investment of US$1 billion, microbicides could be in the hands of women in developing countries within the next five to ten years, potentially saving 2.5 million lives over three years."