Dr. Rees told me that new legislation governing the ethics of clinical trials was now in draft form, and had been under negotiation for more than two years. It would be presented to Parliament soon, she said. I wondered whether the legislation had not come too late for the patients at Kalafong. Clearly it would be important to have such legislation in place before clinical trials of drugs that the government itself alleges can be toxic should be allowed to proceed. As it turns out, the ethical guidelines currently in force were drafted in the 1960s, a time when high ethical standards did not prevail in South Africa. This only deepened my suspicion that the Ministry of Health might have been distracted by the AIDS dissidents and was failing to expedite far more important issues.
On the airplane, I found myself sitting next to a young white South African who worked as a salesman for a Pretoria company that sold CAT scanning machines. He followed the controversies over AIDS pretty closely in the South African newspapers. “It’s all political,” he said. “Everything is political in South Africa.”
I told the CAT scanner salesman about my baffling interview with Dr. Rees, and the extreme evasiveness of so many people in government and other scientific institutions. “You see,” he said, “these people aren’t used to journalists asking questions. During the struggle, they only had to speak to reporters on their own side. Now when a reporter challenges them they think ‘she’s on the wrong side’ and they’ll do anything to avoid you.” I realized that so much of my information about the trial, and about AIDS in South Africa in general, had come from one side only, that of activists like Gazi and de Lille in the PAC, and the lapsed priest, Viljoen. This was why I had not been able, in the three weeks I was in South Africa, to figure out with any certainty what had happened at Kalafong. I had been trapped in a hall of mirrors, and many of them reflected only a particular political agenda.
When I returned to New York, I called the American pharmaceutical company that had sponsored the clinical trial in South Africa and asked them to tell me how many patients died at the Kalafong site. I was surprised to learn that, contrary to what I had heard in South Africa, only one patient on the trial had died at Kalafong. Viljoen had given me the names of the patients whose families said they had died after being enrolled on the trial by Dr. Steenkamp. I called Dr. Steenkamp in South Africa, and she told me that none of these patients were, in fact, on the trial. She would say nothing about the patients who were sick but still alive because, she said, that would violate their privacy. When I told Dr. Steenkamp that all of these patients seemed to think they were on a trial, according to signed testimonies given to me by Viljoen, and all of them claimed to have come regularly to receive drugs from her, Dr. Steenkamp told me she had certainly been treating some of those patients, but she would not say whether they had been on a trial. What on earth was going on?
My first thought was that some of the patients might have been screened for the trial, but because they were already sick with AIDS, they were not eligible. Dr. Steenkamp may have given them some medication, but the patients may have misunderstood and thought they were actually on the trial. Perhaps these people became much sicker right after their appointment with Dr. Steenkamp, simply because the disease was taking its course. When they died, their families blamed the doctor.
The HIV/AIDS epidemic came late to South Africa, but since 1993, the virus has been spreading very fast. Today, 15 percent of South African adults are HIV-positive, but most people were infected recently, in the last seven years. People may live perfectly healthy lives with HIV for a decade, so the great wave of death from AIDS in South Africa is now beginning to break. Perhaps these five deaths were an early swell of this great wave. Perhaps five people died of AIDS and another six got sick. Could it be that the sick ones and the relatives of the dead ones could not accept what was happening, and were looking for a culprit? Perhaps whispers circulated in the townships about a doctor at Kalafong. Hysteria may have ensued, perhaps fueled by reports of the controversy in the President’s office over whether AZT and other anti-retroviral drugs were part of a Western plot and might even be the cause of AIDS. In the eyes of the surviving patients and the families of the dead, Dr. Steenkamp may have been seen as some sort of witch.
But details of the story that just didn’t fit together still perplexed me. Why would six patients and the families of five others think they were all on a clinical trial if they had not been? Why did Professor Falkson, who was admittedly weak on details, tell me that five patients had died on the Kalafong trial if in fact there was only one death there? Why did one of the patients tell Viljoen that after she and the others had received their trial drugs from Dr. Steenkamp, they all sat around together in the lunchroom at the Motivation and Educational Trust, unwrapping their parcels of pills, only to discover that not everybody got the same kinds of pills? Some people got two bottles, some four, and the pills looked different. The American trial was placebo-controlled and blinded, which means everybody should have received exactly the same thing. Why did one of the patients who received drugs from Dr. Steenkamp write in her testimony, “[Steenkamp]â€Śtold me not to talk to anybody else about [the trial] because it was our secret”? When I called Dr. Steenkamp from New York, she insisted that she had not been conducting any other clinical trials with AIDS patients at the time she was working on the American drug trial.
Why did the patients who became ill report such strange symptoms? When Andrew described his symptoms to me, they sounded a lot like Stevens-Johnson syndrome, a potentially fatal, but rare, side effect of one of the anti-retroviral drugs on the trial sponsored by the American pharmaceutical company. But when I spoke to the pharmaceutical company representative, he told me that no cases of Stevens-Johnson syndrome at the Kalafong site had been reported to him. If any cases had occurred there, he assured me he would have known. So if Andrew’s symp-toms were not drug-associated Stevens- Johnson syndrome, what were they?
Molly’s testimony said she was put on a “drug trial,” but she had tuberculosis, which would have excluded her from the American trial. Why, after Molly got sick, was she prevented from looking at her own medical file by the authorities at Kalafong? A friend of Viljoen’s had sneaked into the hospital disguised as a nun and had stolen the file, but when it was opened, Viljoen told me, the most recent three months of notes were missing. And why did Molly say she went temporarily blind? I have spoken to a number of AIDS researchers who have long experience with anti-retroviral drugs, and temporary blindness is not a known side effect of any of them. Blindness does occur in AIDS patients, but it does not get better.
Clinical trials are often surrounded by secrecy. South African politics and evasion obscure matters even further. In early June, I was leafing through old copies of The Lancet in the library and I came across an editorial criticizing Mbeki’s anti-AZT policy.23 “Is there some other agenda,” the author speculated, “such as the promotion of locally developed drugs?” Perhaps South Africa’s paranoia was beginning to affect me too, but I thought of the unauthorized clinical trials of Virodene, and of Mbeki’s interest in the African Renaissance and in finding African solutions to African problems. I also thought of Dr. Makgoba’s reluctance to tell me about South African research into traditional African medicine for AIDS. I began to wonder whether some accident might not have occurred at Kalafong. This seemed unlikely; but what did happen remains unexplained.
President Mbeki arrived in the United States on the same day I did. On Tuesday, May 23, he was interviewed on The NewsHour with Jim Lehrer, and he was asked specifically about his controversial AIDS policies. His replies were a series of evasions. He claimed that he had never said that HIV was not the cause of AIDS, but he did not deny that he had questioned the link between them. Nor did he explain why, if he did not question this link, he had invited Duesberg and his followers to present their views to the presidential AIDS panel. When he was asked why he refused to make AZT available in public maternity wards for the prevention of HIV transmission from mother to newborn child, he answered that the state could not afford to make anti-retroviral drugs available for life to all HIV-positive people in South Africa. But he was not answering the question that had been put to him. He had not been asked why he didn’t provide all HIV-positive South Africans with anti-retroviral therapy for life. He had been asked why he didn’t provide it only to HIV-positive women for a month, or perhaps only a week, around the time they give birth. This would cost about $50 million a year, which the Health Ministry could well afford, especially in view of the fact that it will cost many times more to treat the children who might have been spared HIV infection when they eventually come down with AIDS.
Nevertheless, Mbeki and his government continue to argue that providing these women with anti-retroviral therapy is too expensive and the drugs are too toxic. His critics, meanwhile, continue to argue that the drugs are not too expensive, and that their prices are falling anyway, and that they are very unlikely to be toxic in the short doses used to prevent infection during childbirth.
This issue may be clarified at the upcoming Thirteenth International AIDS Conference in Durban in early July. A group of researchers working at Chris Hani-Baragwanath Hospital in Soweto have been testing a cheaper anti-retroviral drug called nevirapine, to see how well it protects babies born to HIV-positive women from HIV. There is already evidence that it does.24 The government has quietly approved nevirapine pilot projects in public maternity wards, and there is hope that the results of the Baragwanath trials will be encouraging enough for these projects to be approved by the Medicines Control Council.
The science and politics of AIDS can seem complicated, and even illusory, to those who aren’t familiar with them. Like some mystical Hebrew text, it may seem as though they can be interpreted in many different ways. As I watched Mbeki on television dodging every direct question, I felt that he wasn’t being straight with his American audience, or with his own people. He seemed to be hiding something.
The anti-apartheid struggle never quite erupted into a real war, but there is nevertheless a vaguely postwar atmosphere in South Africa, in the self-imposed curfew, the corruption and crime, the drug shortages, the shifty-eyed officials, and in the sense that something terrible has happened there, in a nation haunted by death and ruined lives, with a visionary ruler who has not adequately confronted the most deadly threat facing his country.
"Politicisation of Debate on HIV Care in South Africa," The Lancet, April 29, 2000, p. 1473.↩
Laura A. Guay et al., "Intrapartum and neonatal single dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda," The Lancet, September 4, 1999, pp. 795- 802.↩
“Politicisation of Debate on HIV Care in South Africa,” The Lancet, April 29, 2000, p. 1473.↩
Laura A. Guay et al., “Intrapartum and neonatal single dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda,” The Lancet, September 4, 1999, pp. 795- 802.↩