The Body Hunters (16 page)

But more important, they were threatened. A whole body of research was in jeopardy. If known effective treatments were always provided to test subjects, researchers would only be able to garner useable data when their experimental drugs and methods were as good or better than the stuff already known to work. It was a dangerous idea, as Halsey and others detailed in a flurry of articles in the medical press. How would researchers ever be able to discover affordable interventions like oral rehydration, or micronutrient supplementation, or low-cost surgical techniques if they had to compare them to the standard of care in the cash-flush, technology-rich West? These techniques were, indeed, less effective than the Western standard of care—but more relevant for saving the lives of people with little access to health facilities and inadequate budgets.
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“There is a global obligation to diminish the worldwide disparities in health care,” leading HIV researchers and bioethicists allowed in a joint 1999
Lancet
paper. But “to expect this profound global injustice to be rectified soon is unrealistic.”
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In March 1999, CDC scientists announced results from their placebo-controlled trials. The short course of AZT halved the transmission of HIV, compared to placebo. In Bangkok and Abidjan thousands of HIV-infected pregnant women had jostled for entry into the trials, where the white-coated docs might—or
might not—dole out drugs to save their babies from infection. Over three hundred of those who made it into the trials did not receive AZT, but rather sugar pills. Nearly seventy of their babies came into the world infected with HIV.
⁵¹

The top AIDS researchers and bioethicists who defended the studies wrote a bold “consensus statement” that accompanied the CDC results. The statement began by arguing that these kinds of trials were important and necessary, despite breaching the ethical principle of assuring research subjects the best care. They said the ethical principles themselves had been misinterpreted. According to the statement, placebo treatment of people who couldn't afford to buy effective medicines was the de facto best standard of care. Researchers, no matter how richly endowed with NIH grants, owed such patients no more than that. “You don't want to deny treatment to anyone who would otherwise get the treatment,” said Sommer. But “you're going into Africa where nobody gets anything because the drug is too expensive.”
⁵²

The statements' authors argued that it was “ethically permissible” to administer placebos to HIV-infected pregnant women in countries where antiretrovirals were unavailable. Researchers should provide only the “highest standard of care practically attainable in the host country,” they opined. “There is no obligation to provide study participants with the highest standard of care attainable elsewhere in the world.”
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UNAIDS agreed, in a guidance document released the following year.
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As for Lurie, he had found himself out of a job within two months of the publication of his
New England Journal
paper. His employers at the Center for AIDS Prevention Studies held a major international conference on HIV prevention and failed to even invite Lurie to speak. Enraged and hurt, Lurie quit. “I was furious! I felt incredibly betrayed!” he says passionately, years later. According to Lurie, his former boss had spoken to the surgeon general and the head of the NIH about Lurie's activities. He hasn't worked in AIDS prevention research since.
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* * *

VaxGen's trials of its gp120 vaccine in five thousand gay men in the United States and twenty-five hundred intravenous drug users in Thailand commenced in 1999. Several AIDS researchers took exception to VaxGen's bypassing the NIH decision by moving forward with the Thais. “Majority scientific opinion,” said AIDS researcher John P. Moore, had condemned the gp120 vaccines as failures, but still VaxGen and others “cling to their investments.” Furthermore, they had seduced desperate health ministers and scientists from developing countries with false hope, then paraded their newfound supporters at international conferences to back them up. “I despise . . . Don Francis and all the evil corporate politics you stand for,” railed Moore. “Trying to make money out of the dying is pretty pathetic, really.” VaxGen was “abusing the Thai people for selfish reasons,” he said. Aaron Diamond AIDS Research Center's David Ho agreed. During a visit to Bangkok Ho warned, “For me as part of the Asian minority in the U.S., I feel it's important for the Thai people to be aware of the possibility of exploitation. . . . If a product is rejected elsewhere, why should you take it? . . . It's wrong for some U.S., European, and other researchers to look at this only as an opportunity to develop a product.”
⁵⁶

Providing treatment for the subjects who did become infected in the trial was another sticking point. The VaxGen vaccine was unlikely to protect anyone from an infection, researchers knew, but it might slow the course of the disease. If they treated infected subjects with the lifesaving drugs, it might be difficult to tell if the vaccine had any such effect. Drug treatment could “make . . . it impossible to design a scientifically valid [vaccine] trial,” worried one Johns Hopkins vaccine researcher. It would also burden the vaccine trials with huge drug bills. “This is a monstrous responsibility,” sputtered another clinician. Wouldn't it be unethical, anyway? If they
did
provide the drugs, then people—as yet uninfected with the virus—might sign up just to get the free treatment.
⁵⁷

A compromise solution was found in the design of the trial. In the U.S. arm, for every subject who received a placebo, two would receive the vaccine. They'd also get triple-drug therapy should they become infected with the virus. In Thailand, things would be different. There'd be one placebo given for every active shot. If subjects became infected, they'd get therapies, but not triple-drug therapy, just double-drug therapy. “It works,” said Lurie with disgust, “but not too good.”
⁵⁸

After the CDC's placebo-controlled trials proved that short-course AZT cut HIV transmission nearly as well as the long course, pressure was stepped up on Jackson to drop the placebo group in his trial in Uganda, code-named HIVNET 012, as well. Now that researchers knew beyond a shadow of a doubt that even an affordable short course of AZT—around three weeks worth, given during pregnancy—would help, there could be no decent rationale to withhold the drug from any HIV-infected pregnant woman, CDC advisers told Jackson.

Jackson was aghast. Left with just one group of women taking nevirapine and another taking an even more abbreviated course of AZT—just a couple of pills during labor and delivery—Jackson worried that he might be left with uninterpretable results. “If they had turned out to be similar, we wouldn't have known if neither of them worked or both of them worked,” he recalls. Such inconclusive results, while surely suggestive, would be less likely to find their way into a top-tier journal. Journal editors frown upon fuzzy results, and Jackson knew it. “At the time, I tell you, it was like, this is crazy!” he says. “If we drop this placebo, chances are we won't be able to say anything!” He had received a very large grant to look at an interesting question and had jumped through many administrative hoops in order to get his study started. To then not be able to publish any papers would clearly have been disastrous. Plus, his earlier argument, that withholding the best methods was permissible since the women wouldn't have gotten
better care anyway, still held, he said in 2003. “They said, well, the short course is effective and everybody should just implement it. Well, here we are six years later and nobody is getting it! And we knew that! People knew afterwards that this was wishful thinking. We knew that the standard of care would still be nothing for years to come.”
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But in the end, the aborted placebo arm in Jackson's trial didn't disrupt the study. In September 1999, Jackson and his team published results from HIVNET 012. The nevirapine had worked even better than the ultra–short course of AZT they had administered—and was easier and cheaper. Of the placebo babies born before the placebo group was dropped 36 percent contracted HIV, as did 20 percent of the babies who got the ultra-short course of AZT. Of the nevirapine babies, only 7 percent came down with HIV.

The public response was tremendous. In Uganda the results were announced by the Ugandan minister of health; in the United States, Vice President Al Gore did the honors. “It was a big deal, one of the highlights of my career,” Jackson remembers. “It was high risk, but it was also high return. For me, it's personally been very satisfying. . . . We struck gold with nevirapine.”
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Within a few years Jackson would single-handedly command one of the biggest medical research budgets available to any investigator in the world: nearly $30 million in federal and private grants for AIDS research.
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While Jackson basked in the glory of his results, Lallemant's active-controlled trial was still enrolling patients. Although conceived in 1994, Lallemant's trial didn't commence until 1997. The Harvard researcher had spent over a year convincing skeptical NIH advisers that he didn't need a placebo group.
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And now hundreds of thousands of babies could be saved with cheap, easy, single doses of nevirapine. Jackson had a suggestion to make it even easier, which he and his team outlined in a paper accompanying his results. Why not just give a nevirapine pill to
every
pregnant woman in countries where HIV ran rampant? It
would be easier and cheaper than testing and counseling each one to figure out which ones had the virus. It wasn't as if the women really wanted to know whether they had the virus or not, since antiretroviral treatment was still prohibitively expensive anyway. This way, even if the mothers dropped dead, clueless as to what killed them, their babies might survive. Critics wondered whether such universal drug dosing would suck up vital foreign exchange in poor countries while dismantling vitally important counseling and testing programs that supported Ugandan families of HIV-positive women—the people who would likely care for the women's orphaned children—in a myriad of other ways. Jackson responded with a popular refrain, which he'd repeat in papers and interviews on the subject: “don't make the best the enemy of the good.”
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Charity groups quickly started distributing nevirapine in their clinics in poor countries. But strangely, some of the worst-hit countries in the world remained stubbornly resistant to the drug's wonders.

Most Americans' lives are so intertwined with the ministrations of Western medicines from childbirth to daily aspirin that belief in its healing prowess is nearly an article of faith. But this isn't so in most of the rest of the world. About 80 percent of people living in developing countries—together comprising 64 percent of the total world population—rely on traditional healers, not Western biomedicine, according to University of California pharmacologist Mannfred Hollinger.
¹
And in parts of the world where Western medicine's foothold is flimsy at best, shoddy clinical trials can fuel a corrosive mistrust that undermines allopathic medicine more generally, with potentially devastating results.

Nowhere has this phenomenon been more apparent than in South Africa, where periodic controversies over flimsy subject protections in clinical trials ignited a volatile mix of racial resentments and mistrust accumulated over nearly fifty years of apartheid.

Between 1948 and 1994 the white minority in South Africa, descendants of Dutch, German, and French immigrants, doled out rights and privileges according to a schizoid system of racial apartness, “apartheid” in Afrikaans, the Dutch-like language they originated.
²
When AIDS first emerged in the mid-1980s white conservatives in the country rejoiced openly. “If AIDS stops black population growth,” one said, “it would be like Father Christmas.”
³

Apartheid had already started a slow genocide among black Africans in the country. Between 1960 and 1983 South African police had forcibly relocated over three million nonwhite South Africans from their homes into racially segregated “townships”
and “homelands,” isolating them from the rest of society. While the government devoted 97 percent of its health care budget to high-tech specialized care, culminating in a revolutionary heart transplant in Cape Town's Groote Schur Hospital in 1967,
⁴
blacks were suffering forty-eight times more typhoid fever than whites and their children were dying from easily preventable diseases such as measles. In the townships tens of thousands of people might share a single water spigot. Conditions such as kwashiorkor, a severe form of malnutrition, raged, but the health department failed to take even minimal control measures. Black patients died waiting for ambulances to pick them up, while those reserved for whites idled nearby; those who survived the wait sometimes perished outside empty white hospitals that refused to let them enter.
⁵

Notwithstanding notable exceptions, the mostly white South African medical establishment complied with apartheid's strictures. Some medical researchers openly studied the supposed inferiority of blacks and new bacteria that might selectively injure or kill them. The South African Medical and Dental Council extolled the physician's right to “decide to whom he or she wanted to render a service in non-emergency situations.” Doctors worked for the security police, witnessing whippings and other torture, and signed off on fraudulent reports that those who succumbed were victims of accidents or suicides.
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