The Body Hunters (17 page)

When the apartheid regime finally fell to the African National Congress (ANC) in 1994, the problem of AIDS remained off the official agenda. ANC loyalists suspected that racist Western researchers had exaggerated the problem. Back in the 1980s NIH researchers had in fact circulated grossly inflated reports of HIV infections in African countries—Robert Gallo had reported that two-thirds of schoolchildren in Uganda were infected; National Cancer Institute researcher Robert Biggar, that between a quarter and one-half of the Kenyan population hosted the virus
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—based entirely on faulty assays.
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Hasty conclusions about HIV originating in Haiti had crippled that impoverished nation's tourism industry.
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When Kenyan leader Daniel arap Moi condemned AIDS as
nothing more than some “new form of hate campaign” against African economies,
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many ANC supporters agreed. “It seemed far-fetched that a disease would conveniently kill fags, prostitutes, drug users
and
blacks,” recalls one South African ANC loyalist. “It was a Reaganite wet dream!”
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The comforting illusion that AIDS was an overhyped nonproblem wouldn't remain intact for long. By the mid-1990s the virus's rampage on the continent had become all too clear. But the Western AIDS establishment once again appeared unhinged from African realities. Many now proclaimed that Africans were too backward for combination antiretroviral therapy, suggesting a vicious indifference to the plight of impoverished Africans.

The insinuation that Africans couldn't be trusted with antiretroviral drugs outraged South African nationalists such as shaggy-haired activist physician Costa Gazi. Gazi had spent two years in prison during apartheid, and says he feels the same way about the fight against AIDS as he did the struggle to end apartheid. “Diabetics living in rural areas get tested once a month; we don't say let's not treat them!” Gazi says.
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When at last in 1997 South African legislators amended the country's Medicines Act to allow the health minister to make HIV medicines affordable by breaking patents and buying cheap generics, Western interests appeared once again committed to blocking Africans from accessing the lifesaving meds. Though the measure only applied during health emergencies or when patented medicines were unaffordable, thirty-nine major drug companies marched into court to prevent the law's implementation. “The law is arbitrary and gives the health minister too many powers,” Mirryena Deeb of the trade group Pharmaceutical Research and Manufacturers of America (PhRMA) complained. “The minister can make a decision that a drug is too expensive and the drug companies have no right to defend themselves.” The Clinton administration promptly placed South Africa on its “watch list” of patent pirates.
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With earlier suspicions about the Western medical establishment thus reinforced, ANC officials set about finding an African solution
to the problem. In 1997, Thabo Mbeki, then a prominent ANC official, believed he had found one such solution in a drug called Virodene. Virodene was cheap and, according to its University of Pretoria developers, remarkably effective against AIDS. The South African Press Association accepted the developers' claims as they were presented to President Mandela's cabinet. “South African researchers find a cure for AIDS for fifty rand a month,” local headlines blared.
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Within days the fact that data supporting Virodene had not undergone standard peer review and stemmed from a single trial involving twelve people emerged, and apartheid's ruling party, the National Party, was calling for the ANC health minister to be sacked for supporting the drug. By April 1998, German researchers established that Virodene was an industrial solvent that caused severe liver damage and had no effectiveness against AIDS.
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When the mostly white media and white medical establishment lambasted Mbeki for his error, ANC supporters took it as an affront. “If they had their way, we would all die of AIDS,” the health minister muttered.
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It may not have bothered Mbeki that Virodene had been rejected by drug regulatory officials in the country, because as he would later expound, such officials along with much of the rest of South Africa's medical establishment were still dangerously biased against Africans. The South African Medical and Dental Council had retained most of their senior staff from the years of apartheid. The council hadn't investigated reports of medical negligence, fraud, or human rights violations committed by doctors under apartheid. According to a scathing report by Physicians for Human Rights, the “vast majority” of South African doctors accused of abusing patients during the apartheid era still practiced medicine, in some cases holding top positions in the government, universities, and other institutions.
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By the time Mbeki took the helm of the South African government in 1999, his antipathy toward the Western AIDS establishment had gone rigid. According to Mbeki, received truths from
Western AIDS experts were a mix of lies and half truths. The idea, promoted by Western AIDS researchers, that HIV came from Africa was “wild and insulting,” he said. They claimed that the disease could only be tamed by expensive, Western-made antiretroviral drugs, despite what he called a “large volume of scientific literature” that deemed the drugs “a danger to health.” In fact, according to Mbeki, HIV was harmless and the condition called AIDS was simply a new name for malnutrition and other diseases of poverty. By then, about one-quarter of all pregnant women in South Africa appeared to be carrying the virus, according to annual antenatal surveys, but the government refused to pick up the tab for any antiretroviral drugs to treat the women or prevent the virus from infecting their infants.
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In desperation, physicians like Gazi had taken to smuggling in bags of nevirapine pills from the United States to provide to their pregnant HIV-positive patients. Mining companies such as Anglo-American, realizing that they could lose nearly one-fifth of their miners to the disease, offered to provide antiretroviral combination therapy to their employees. But the overwhelming majority of AIDS sufferers in the country went untreated, and the virus continued its passage from mother to child unimpeded. By 2003, South Africa was home to the greatest number of HIV infected people on earth. Most had never swallowed a single antiretroviral pill, a decade after the approval of AZT and years after combination antiretroviral therapy had transformed the disease in the West.
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These demographics did not go unnoticed by drugmakers and CROs casting about for new test subjects to service the $5 billion AIDS-drug market, one projected to mushroom to nearly $15 billion by 2007.
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CROs flocked to the country to conduct trials on untreated South Africans, and cash-starved medical facilities welcomed them with open arms. At institutions like the University of Stellenbosch drug companies would soon be proposing over sixty new trials every year.
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Industry researchers struggled to discern the effect of their new drugs in Western patients who already had dozens of other
meds coursing through their veins. “You want relatively clean patients, with no other disease states and no other treatment,” explained Simon Yaxley of MDS Pharma, a company that recruits experimental subjects in Eastern Europe, South Africa, Latin America, and China for multinational drug companies. “Then you can say relatively clearly that whatever happens to that patient is from the drug.” For testing new AIDS drugs, he said, “South Africa is a great country. . . . There are a lot of individuals [with AIDS] who are not treated.”
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Indeed, echoed a PhRMA spokesperson, “treament-naive patients”—those who have never been exposed to any drug treatments—are “a very important group.”
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For former Genentech marketing executive Richard Hollis experimental access to South Africa's med-deprived masses would prove crucial. A squat, richly suited man with closely cropped hair, Hollis had left Genentech to “create a new Eden on earth,” by selling miracle cures through his new start-up drug company, Hollis-Eden.
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In 1994, Hollis had acquired rights to a steroidal hormone that he hoped might help prevent the onset of AIDS in HIV-infected people. The trouble was that his scientists could only measure the drug's effects in HIV-infected people if they weren't already taking antiretroviral drugs. Powerful antiretroviral therapy would mask the weak effects of the humble steroid as an espresso would a cup of chamomile tea.

The drug, Immunitin, could nevertheless be worthwhile, Hollis said. “If we're correct in our approach, we could potentially help more than 1 billion people,” he proclaimed. After all, “you can't go to third-world countries with $10,000 therapies,” he said. “You have to produce drugs that are inexpensive to manufacture and easy to administer.”
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In 1998, the CRO Quintiles helped the company arrange a short, three-month trial of Immunitin on forty untreated HIV-positive patients in South Africa. According to the disgruntled local press, “the firm want[ed] to avoid the expense of satisfying US regulators until SA guinea pigs have proved that the investment is worthwhile.”
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(Six months later the company did start a trial of
the drug in American patients but there the FDA insisted that the company only enroll patients whose antiretroviral drugs had stopped working.
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)

When the results of the 1998 trial turned out to be inconclusive, investors started getting snappish about the company's ability to get a drug on the market. “They may have the greatest thing since chopped liver, but no one is biting,” one wrote in 2000. “Investors aren't quite sure what is going on, if anything is going on.”
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The company quickly slapped defamation suits on one of its critical stockholders
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and launched a longer, more rigorous trial of Immunitin. This time, they'd test Immunitin in much sicker untreated AIDS patients.
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Twenty-five South Africans dying of AIDS—their CD4 cell counts numbered less than fifty, well below the two-hundred-count level considered dangerous—were duly enrolled. None were given antiretroviral drugs. Half were given Immunitin in the hope that it would protect them from opportunistic infections. The other half were given a placebo. Hollis-Eden tracked their deterioration for over a year. Eight months into the study, Richard Hollis donned an African-style tunic to have his picture snapped with Nelson Mandela.
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Later, data in hand, the company sighed contentedly. “We proved our point,” exulted one Hollis-Eden executive. The Immunitin had indeed slowed the deterioration of some of the patients, although the numbers were small. Whatever happened to the test subjects after the one-year trial, the company didn't really know. If they had wanted more Immunitin, they would have been out of luck. The company stopped providing the drug after the study ended.
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Finding few Western donors interested in paying for a non-antiretroviral agent for their AIDS programs and governments capable, if they wanted, of overriding the company's patent on Immunitin, in 2002 Hollis-Eden put its Immunitin development program “temporarily on hold,” according to its 2004 report to investors.
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Meanwhile, other clinical researchers in South Africa, even those conducting more patient-friendly protocols than Immunitin's year-long placebo trial, were getting caught coercing and misinforming their research subjects. “Many patients have no idea what their rights are as patients, even in a therapeutic setting,” says University of Stellenbosch bioethicist Keymanthri Moodley. “A lot of people get away with many things in South Africa!”
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In 1999, for example, Quintiles had helped a subsidiary of the $11 billion biotech company Gilead launch a five-hundred-patient trial of its new antiretroviral, Emtriva.
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Some subjects complained about the trial to Costa Gazi who, as the health spokesperson of the dissident Pan Africanist Congress Party, set off to investigate. According to Gazi, one patient was told neither that the drug therapy wasn't a cure nor that he was allowed to leave the study. Others added that the informed consent process consisted of a few minutes' long conversation and an instruction to “sign on the line to get a drug that will cure them.” Still others said they were never asked for any written consent at all.
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As for the ethics “committee,” it consisted of a single retired professor.
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When patients in the trial started perishing, mistrust between test subjects and investigators surged. After the sixth patient died the researcher in charge of the study site where the death occurred flatly denied the patient had been enrolled, or had even taken any AIDS drugs, despite the fact that reporters had acquired a copy of her consent form inducting her into the trial.
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But what had killed the test subjects? They were sick with AIDS, after all. And the regimen given to subjects, unlike in the Immunitin trial, was quite involved. Some were given Emtriva along with d4T and nevirapine; others lamivudine along with d4T and nevirapine.

According to Gilead's consulting scientist, University of the Witwatersrand's Ian Sanne, the liver failures that had contributed to some of the deaths stemmed from the nevirapine, a conclusion Sanne and other Gilead scientists later published in the
Journal of Infectious Diseases
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That is, the same drug that was just then being
recommended, thanks to Jackson's 012 study, for South African pregnant women and their newborns. True, in the Emtriva study patients sick with AIDS had taken nevirapine for months on end—to prevent infections in babies, only a single dose was necessary. Prescribed in this way, nevirapine had the potential to save thirty thousand South African babies from HIV infection every year.
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But to Mbeki such distinctions hardly impinged upon the facts as he saw them: “Our people are being used as guinea pigs and conned into using dangerous and toxic drugs,” he insisted.
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“It would be immoral and unethical for government, despite the numerous requests we are receiving . . . to attempt to make policy decisions regarding the use of nevirapine in our country,” Mbeki's health minister declared in 2000.
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