Swapna Prabhakaran
Pregnant women undergoing controversial Aids drug trials at the Chris Hani Baragwanath Hospital are fully aware that they stand a one-in-four chance of receiving a placebo.
Despite this, the women this week gave their full support to the programme which has been slated by a top United States medical journal for being unethical.
The New England Journal of Medicine criticised a string of similar trials in the developing world for denying some of their volunteers access to treatment which had become standard procedure in the US. Instead, those volunteers receive placebos.
But the local volunteers insist they know exactly what they are getting into and fear that coverage of the US criticism could threaten the programme.
Dr Glenda Gray, who works on the programme, says all volunteers get a full explanation about the research beforehand, to ensure informed consent. If they do not speak English, a translator is brought in to make things clear.
We tell them about the placebo, we call it a spaza-drug or a chuff-chuff [pretend] drug. They do recognise that its somehow unfair, but theyre willing to take the chance.
She says some volunteers specifically request not to be given the placebo. They say they dont want to be on the spaza- drug, but its just a lucky dip. You have to take your chances. Most of them realise the odds are quite good that theyll get an active drug.
The women volunteers at the project say they are upset that the research they are participating in may be seen as unethical.
One volunteer, using the pseudonym Zodwa, says the details of the research and the placebo were fully explained to her before she signed up. I am in this study because I want it to go on. I know about this chuff-chuff … It is helping us. We signed the forms so we know about it.
She says the chance to participate in the study even if it is by taking a placebo is what is most important for her. I am doing this for the coming generations, not for myself.
Similar trials are being run at the King Edward Hospital in Durban.
The Mail & Guardian reported last week that The New England Journal of Medicine accused the study of unethical practices because placebo-control testing would be unacceptable in the US as AZT is easily available there. But local doctors say there is no similar situation in developing countries like South Africa.
Lucy Blamey of the Aids Law Project rejected the journals claims as highly spurious.
AZT is not available to women in South Africas public health system because of cost and lack of infrastructure needed to administer the drug.
The trials conducted at Chris Hani Baragwanath and King Edward hospitals which comply with international ethical standards represent the first attempt to make AZT available to pregnant women in this country, Blamey said.
Head of the research unit at Baragwanath, Dr James McIntyre, said: It [AZT-control testing] is not viable financially or logistically in South Africa.
The researchers are trying to determine whether a short-course treatment of AZT- which is usually administered for long periods during pregnancy can reduce mother-to-child transmission of the virus.
The study uses four arms: three out of every four of the women receive different levels of the active drug and one of every four is given a placebo.
The placebo, which looks exactly like the real drug, acts as a control against which the other results are measured. Neither the doctors nor the patients know which of the volunteers are receiving the placebo.