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10/02/2007 18:53  - (SA)  
‘Guinea pig’ story on HIV prevention worrying ln id
MARK HEYWOOD and FRANCOIS VENTER    

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The article in City Press last Sunday (Women used as Aids guinea pigs) and the subsequent controversy around the ending of the Ushercell microbicide trial ­requires a response from South Africans concerned with preventing infectious disease and developing scientifically proven interventions.

In recent years, South Africa has been the victim of a large number of fraudsters who ignore scientific process, marketing unproven and potentially dangerous “cures” and interventions. People with chronic illnesses, especially serious ones such as HIV, are very vulnerable to claims about “miracle” treatments.

Recognising this, we support scientific research that strives to obtain answers in the most rigorous way possible, observing national and local ethics oversight committee guidance.

South Africa has a grave Aids epidemic. Consequently, we desperately need HIV-prevention technologies that work for vulnerable populations. Microbicides are theoretically very exciting as women are able to control their use. Indeed, even if a woman chooses to disclose the use of a microbicide to her partner, she would initiate the application (unlike a condom).

Obviously, HIV prevention trials require enrolment of people at risk for HIV, and we know that women and girls are disproportionately at risk. But in addition it is essential that trials are conducted in the communities where these products are most needed.

Internationally, we have learnt that communities that participate in HIV prevention trials, including trials for a vaginal microbicide, experience a decreasing HIV incidence. This is due to vigorous condom promotion, counselling on HIV risk reduction and HIV voluntary counselling and testing offered during the process when volunteers are recruited to these trials.

In this regard the City Press article is worrying. By characterising people as “guinea pigs”, it suggests that the women recruited for the study had no say in, and were ignorant about, their participation. Later in the article it is implied that payment for travel costs (at a rate set by the Medicines Control Council) is a dishonest method of persuading people in poverty to participate. The reference to “US funded” research suggests that external researchers are forcing their research agendas onto developing populations.

However, the facts are different:

. The department of health was consulted on the study, and supports the development of a microbicide for HIV prevention.

. The study is run by a respected local researcher, part of a South African research unit that is internationally renowned for quality and integrity.

. The researcher advised international leaders of the study on the study design.

. The study was conducted using a microbicides product that had already been tested extensively.

. The study was vetted by a very credible local ethics committee.

. Women participating were offered levels of care, counselling and treatment beyond those generally available in the public sector.

. The study is regularly evaluated by independent safety boards for the safety and ethical treatment of participants. Such an independent board recommended its termination.

. There are no reports to suggest the study was run poorly or unethically.

The fact that the product failed to protect women from HIV and, may possibly have made HIV transmission rates higher, is a tragedy. However, there is no other way of evaluating potentially valuable microbicides.

) Heywood is the director of the Aids Law Project and Dr Venter is president of The Southern African HIV Clinicians Society

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