Delivering a disaster?
By Michael Day BY 2005, 61 out of every 1000 babies born in South Africa are expected to die before they reach their first birthday. Without AIDS, that figure would be 38 out of 1000. These latest statistics from UNAIDS, the UN agency responsible for tackling the disease, published in December, show that the spread of HIV is rapidly reversing years of steady improvement in child survival rates in sub-Saharan Africa. In the light of this, Tony Blair’s pledge this month that Britain would donate £100 million to the fight against HIV in the world’s worst-affected continent seems highly appropriate. The Prime Minister announced the aid package this month during his visit to South Africa, which will receive the largest proportion of the money. However, there are serious worries among international AIDS experts over South Africa’s ability to fight the AIDS epidemic. These concerns centre on the policies of the health minister, Nkosazana Zuma. Zuma has advocated use of an unproven, locally developed anti-HIV preparation called Virodene and blocked nationally funded trials of the drug AZT to prevent pregnant women with HIV passing the virus to their babies. This month, her policy ran into further trouble when South Africa’s Medicines Control Council for the second time rejected a proposal to subject Virodene to clinical trials. A huge weight of clinical data shows that giving AZT during pregnancy can slash the rate of transmission of HIV from mothers to their children by 50 to 70 per cent (see This Week, 19 September 1998, p 18). Experts say that trials are needed in South Africa to fine-tune how the drug should be distributed and administered to suit local conditions. But few are in any doubt that it is badly needed to treat the country’s growing numbers of AIDS babies. “It’s analogous to an AIDS vaccine for children,” says Kevin De Cock, head of the HIV and AIDS prevention unit at the US Centers for Disease Control and Prevention in Atlanta. He says the issue is more one of child health than AIDS prevention. “AIDS is already having a big impact and reversing gains in infant mortality.” Whatever their personal opinions, UNAIDS officials are reluctant to openly criticise national policies. “We would have preferred if the South African government had given the go-ahead [to AZT trials],” says David Miller, a UNAIDS policy adviser. “But we will go on working with the government to fight AIDS in South Africa.” Zuma’s spokesman, Khangelani Hlongwane, claims that Zuma’s policy is based on cost. He says the country cannot afford to fund the use of AZT. “We accept all the scientific findings but we don’t have the budget for it,” he told New Scientist. “We will use the money for AIDS awareness. We have to ask, how do we prevent the majority of the population who aren’t infected from contracting the disease?” He says it would be unfair if the government gave some pregnant women the drug and then found itself unable to continue supplying it once the trial had finished. This, he maintains, explains why Zuma turned down an offer by the French-based medical agency International Solidarity to pay for the trial. In neighbouring Botswana—which has a similar per capita GDP—the government has already decided to make the drug available to pregnant women who are HIV-positive. But Hlongwane says: “This is not Botswana, this is South Africa. They’ve been doing things in Botswana in terms of housing, health and infrastructure that we haven’t been able to because of the political situation here for so many years.” Nonetheless, leading medical researchers in South Africa, such as Glenda Gray, co-director of the University of Witwatersrand’s perinatal HIV research unit at the Chris Hani Baragwanath Hospital, are scathing of Zuma’s stance. “It’s the most absurd thing I’ve ever heard,” says Gray. “They’re spending money on paediatric AIDS treatment and there’s no limit on this spending, which is costing $100 a day per child.” Over five years, the government would make significant savings if it invested in AZT therapy to prevent children contracting HIV in the first place, she says. “Botswana did the costing and that’s why it’s offering the drug to every woman who wants it.” Some HIV researchers suggest that the South African government is trying to force Glaxo Wellcome, the manufacturer of AZT, to lower the price of the drug. But this seems unlikely given that the company has already cut the price of AZT for pregnant mothers by three-quarters. The cost to the South African government of a four-week course of AZT, normally enough to treat a pregnant woman, would be around $250. Gray believes that the real reason for the government’s stance is that it got its original financial calculations badly wrong and is sticking to its guns despite the plethora of evidence to the contrary. “I think they made their decision on misinformation and now they don’t want to backtrack.” John Moore, a British AIDS researcher who now works at the Aaron Diamond AIDS Research Center in New York, says the British government should be asking if its donation will be spent wisely by South Africa’s health ministry. He says Zuma has seriously disrupted AIDS research in South Africa in three ways: by blocking AZT therapy for pregnant women, by funding an AIDS awareness campaign that collapsed when the organisers squandered the money, and by promoting Virodene. Virodene was developed at the University of Pretoria and has been promoted since 1996 by a small spin-off company called Cryo-Preservation Technologies, which is run by the drug’s inventors. The active ingredient in Virodene is dimethylformamide, a highly toxic industrial solvent. According to the National Poisons Information Service at Guy’s Hospital in London, dimethylformamide is a liver poison and irritant that can cause stomach pains even on inhalation. It also affects the heart, kidney and nervous system. But Zuma has been keen to promote the drug as a home-grown breakthrough in AIDS care, openly encouraging the researchers and supporting them at press conferences. The manufacturers, who claim the drug has helped some patients, started clinical trials despite failing to get ethical approval from the University of Pretoria or South Africa’s Medicines Control Council. After the MCC refused to endorse the trials, Zuma replaced its members. Hlongwane says the sackings were the result of a review of the council that was already taking place. The new council this month issued a damning report on Virodene, rejecting yet again calls for clinical trials. Hlongwane says this verdict will be respected by the government. The Ministry of Health was, he says, simply keen to explore all avenues of AIDS research. But some AIDS researchers and activists are so angry about Zuma’s policies that they are even threatening to boycott an AIDS conference to be held in Durban next year. Senior officials from the International AIDS Society, which is organising the Durban conference, will meet Zuma to try to persuade her to change her mind on the use of AZT in pregnancy and head off controversy before the meeting. A more effective force for change might turn out to be South African women themselves. Despite Zuma’s freeze on state funding of AZT therapy, Western Cape province announced on 5 January that it had found the money to give AZT to pregnant mothers with HIV. So far, 98 per cent of pregnant women arriving at clinics in the vicinity of Cape Town’s Khayelitsha township have agreed to be tested for HIV and to receive AZT if they are infected. With such a high demand for the treatment,