Mungo Soggot
An influential United States medical journal has accused South African doctors of endangering the lives of scores of babies to test new drug treatments for pregnant women infected with the HIV virus.
The New England Journal of Medicine says the drug trials which deny some of their human guinea pigs effective, available treatment violate established medical ethics.
In its September 18 issue, the magazine warns that the trials and 14 similar tests running in other developing countries will lead to hundreds of preventable HIV infections in infants.
Doctors carrying out the tests are furious about the slur, with one dubbing it a form of moral imperialism.
The South African trials are aimed at finding a cheaper, simpler way of giving drugs like AZT to pregnant, HIV-infected women a complicated, expensive treatment pioneered in the US. The local trials also use AZT, but over shorter periods, according to the Medical Research Council.
The South African tests involve giving some women placebos blank samples instead of comparing their findings with the expensive USAZT treatment.
But the journal says: Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo. When effective treatment exists, a placebo may not be used.
The New England Journal of Medicine compares the developing-country trials using placebos to the infamous Tuskegee study in which black Americans with untreated syphilis were denied penicillin after it became available.
It says justifications given for placebo- controlled trials are reminiscent of those for the Tuskegee study: women in the Third World would not receive [the] treatment anyway, so investigators are simply observing what would happen to the subjects infants if there were no study.
Professor Jerry Coovadia, who is running trials at the King Edward Hospital in Durban, says that at a recent conference on HIV in children, African researchers agreed their work should not be subjected to US opinion. It is an insult to South African institutions which have a very ethical history. Its moral imperialism. We have been through a major war against racism. It is amazing that they are preaching that we must consult them.
Coovadia disputes that the expensive US AZT treatment known as ACTG076 is the ultimate standard of care that should be applied. He says the treatment could be inappropriate for South Africa where, for example, many women breastfeed their children. Breastfeeding is one of the main ways of transferring the HIV virus between mother and child.
Coovadia, whose programme is funded by the United Nations Aids Programme (UNAid), says he is preparing a reply to the journal and hopes to secure the backing of the Ministry of Health.
He says UNAid is happy with the ethics of the programme. Doctors running a similar programme at Chris Hani Baragwanath Hospital in Soweto could not be reached for comment.
Professor Salim Abdool-Karim of the Medical Research Council, who is involved in both programmes, says most local experts agree that very complicated US treatments which can save the life of one of every seven babies born to HIV-infected women are too expensive and impractical for South Africa. He says they rely on pregnant women seeking treatment very early in their pregnancies, and their success hinges on a series of follow-ups.
Abdool-Karim adds it is too simplistic to say South Africa and other developing countries should simply adopt the US standard of care for HIV-positive pregnant women.
In South Africa, he says, there are two standards of care: for patients with medical aid and access to private hospitals, and for the majority of the rural poor, who are treated by the public health system.
He says most private South African hospitals offer patients the US treatment, whereas most rural hospitals do not. That means the minimum standard of care for pregnant HIV-infected women in South Africa is no treatment at all or a placebo.