There is a ”turf war for human subjects” as pharmaceutical clinical trials increased 16 times in low-income settings such as Africa, the Microbicides 2006 conference in Cape Town heard on Wednesday.
This is according to Professor Ames Dhai, head of Bioethics at the University of the Witwatersrand Medical School.
Scientists are in a race, albeit tortoise-slow, to see who can get the most effective microbicide, a gel that could prevent HIV transmission in women and that could raise billions of dollars for the first effective product and possibly even a Nobel prize for the winning researchers.
Close to 10 000 women are involved in microbicide trials, most of them in Africa, with dangerous products often being used, including lemon juice by Australian researchers on Nigerian women — which was found to be extremely damaging to the vagina.
Dr Benoit Masse of the Statistical Centre of HIV and Aids Research and Prevention in Washington, United States, said an effective microbicide could be ready in as early as one year, or as late as
five years.
He said true efficacy could be measured in trials involving 100 000 women, but this exceeded by ten times the number of women involved in trials globally.
Dhai raised questions about whether the patients’ rights were always paramount. She observed that clinical trials tend to be focused in ”geo-areas of political and economic instability with unequal social context”.
This highly lucrative field for doctors and medical researchers see them ”battle over who gets these patients so they can say to the sponsor ‘I can line up 500 patients tomorrow’.”
Dhai said ”international standards of ethics have starkly failed to deal with local contexts and experience shows ethical imperialism”.
She emphasised that this not only failed to protect patients adequately but also saw Northern countries display this ethical imperialism over doctors in resource-poor, but information-rich settings.
”We see this involving medical journals.” She gave the example of a study around male circumcision and the fact that those circumcised seem to be at lower risk of HIV transmission than uncircumcised men.
”The researchers gave the evidence to a leading peer review journal and were turned down because they said research patients had not been informed of their HIV-positive status and referred for treatment.
”However, the researchers had told patients of their right to go for voluntary counselling and testing (VCT), with the emphasis on voluntary, and there was a VCT site not more than 200m from the researchers. At that time too there were no antiretrovirals available for patients in South Africa.
”There is also no evidence that informing an HIV-positive patient of his status will lead to an increased likelihood of him practising safe sex.” — Sapa