Health Minister Manto Tshabalala-Msimang on Monday voiced concern about the ethics of current clinical trials on microbicides.
The recruitment and compensation of candidates who suffer complications from clinical trials in developing countries needed further discussion, the minister said at the start of a three-day international microbicides conference in Cape Town.
Researchers say vaginal microbicides, hailed as a potentially powerful tool in the fight against HIV/Aids, typically take the form of a gel that kills or inactivates HIV cells during sex.
Tshabalala-Msimang said there were several potential microbicides being tested globally, with five out of six products in an advanced stage of being tested in South Africa and elsewhere in the world.
”In a community that is poor, providing financial compensation could prove to be perverse incentives. As we know, the poor may become desperate to receive these incentives despite risk. Therefore, informed consent becomes even more critical,” Tshabalala-Msimang told delegates.
Tshabalala-Msimang said research participants needed to receive the necessary care for the management of conditions they may be exposed to by addressing issues such as adequate insurance.
”The type of insurance that is available for research participants in developed countries should be extended to participants in developing countries. It is unethical that participants in one multi-country study should have unequal levels of protection,” Tshabalala-Msimang said in a speech prepared for delivery.
She said South Africa provided a unique environment for research, with increasing research activity, competition and an attractive research environment possibly contributing to unethical practices.
Tshabalala-Msimang touched on the debate surrounding the use of nanoxynol-9 or ”N9”, saying she was pleased it was being discussed at the conference because ”when I first heard about the results of the N9 study conducted in South Africa I was very concerned”.
According to the Global Campaign for Microbicides website, N9 is the same active ingredient found in over-the-counter birth control products, and is still found in some sexual lubricants and on spermicidally lubricated condoms.
A call to discontinue rectal use N9 — widely thought on the street to provide added protection for safer sex — was made with studies in humans and mice suggesting an increased susceptibility to contracting HIV/Aids.
”As a health minister, it is my responsibility to ensure that the health of citizens of our country, particularly women, is not adversely affected in the process of research. Let us reflect on the lessons learnt in the N9 study and plan future studies with these lessons in mind to avoid similar problems.”
She said the development and marketing of effective microbicides would have a great impact on the wellbeing of women and their children.
Tshabalala-Msimang said the invention of an effective microbicide would ensure that the health of women in relation to sexually transmitted infections would no longer depend on their ability to negotiate safer sex and the ”balance of power” in their relationships with men.
”As you know, while condoms remain an effective intervention in the prevention of sexually transmitted infections and unwanted pregnancies, their effective use remains very much dependent on the cooperation of men.
”Therefore, microbicides represent empowerment for many women who need to protect themselves from the risks associated with unprotected sex,” she said. — Sapa