The Body Hunters (27 page)

Alarmed, the Cambodian prime minister shut down the trial.
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Four months later, Thai AIDS activists starting making noises about the tenofovir trials in Thailand as well. Drug users in Thailand suffered an HIV infection rate of 50 percent and were violently oppressed by the government. How could researchers possibly protect their best interests, as required by the Declaration of Helsinki? They couldn't even provide clean needles, the single best known measure of HIV prevention for intravenous drug users, a “particularly egregious departure” from Helsinki standards requiring researchers to provide all experimental subjects with the “best current” methods.
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A month later, ACT UP Paris surrounded the Cameroon embassy in France, condemning the Cameroon tenofovir trial as unethical too.
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By February 2005, the Cameroon Ministry of Health had suspended the study.
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In
March 2005, researchers themselves canceled the tenofovir trial in Nigeria.
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The AIDS research community was roiling. “It's a disgraceful day for AIDS activism,” said Mark Harrington, an AIDS activist with the New York–based Treatment Action Group.
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“These forces threaten to derail future trials,” complained two AIDS-vaccine NGOs, Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition, in a statement. “The cost is paid in people's lives—the lives of those who might benefit from new technologies or treatments.”
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Sure the experiments entailed some risk, but look at the benefits, they said. Tenofovir prophylaxis is “perhaps the single greatest near-term hope for the prevention of AIDS,” the
Wall Street Journal
reported.
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If tenofovir worked, it could “revolutionise AIDS prevention,” echoed the
Financial Times
.
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But for whom?

Researchers hadn't determined whether sex workers in Cameroon really would pop a prescription pill every day for the rest of their working lives, or if so, whether they would be able to afford it. “Would it be a sustainable preventive tool? We don't know enough about that,” allowed Mitchell Warren of the AIDS Vaccine Advocacy Coalition.
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Maybe it would be. Western researchers had thought Africans wouldn't take ARVs or use condoms, but they did. On the other hand, it wasn't peevish to suggest that maybe it wouldn't. Gilead announced that it would sell the drug at cost in poor countries—85¢ compared to $12 per pill in the United States
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—but according to Médecins Sans Frontières spokespeople, the company had neglected to apply for marketing approval in poor countries, making the nice-sounding offer “a virtual one.”
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What's more, the most obvious precedent—antimalarial pills to prevent malaria—had done little to prevent millions of people in developing countries from that scourge. Those drugs are enjoyed almost exclusively by Western travelers, not by people who live in malarial regions.

It isn't that quantifying the potential benefits lies beyond the ken of science. In fact, researchers had already delved into the
questions of how the drug, if proven effective, could be administered and to whom; what clinicians might do if the drug were not fully effective; how subjects might afford to buy sufficient quantities of the drug; whether they were likely to take them faithfully or not; and what would happen to them if they didn't. The only problem was, that analysis had been conducted for California.
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Meanwhile, the risks of the trial appeared to build. In February 2005, CDC scientists revealed that all the monkeys they had dosed with tenofovir had gotten infected with simian HIV anyway.
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The AIDS Vaccine Advocacy Coalition continued to tout the benefits of the trial to developing countries as an article of faith. “It could be used by millions of people,” the group wrote in defense of the besieged trials. “The world loves biomedical answers.”
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Could activists in developing countries be blamed for wondering: which part of the world?

Fully realizing the promise of medical research, whether inflated or not, requires a gargantuan effort for which researchers can't, on their own, bear responsibility. They just provide the data. Patients, clinicians, health care companies, and national governments, among other entities, are the ones who have to translate scientific results into action. But there are other benefits of clinical trials—more limited in scope but more tangible—that investigators can easily facilitate, such as making sure that trial subjects have access to the study drug (if proven effective) after trials end.

And yet, anecdotal evidence suggests that both industry and academic researchers are generally reluctant to take on the responsibility. That's the government's job, not theirs, they say. “It is hard to ask the sponsor of the trial to make up for the fact that the country isn't providing treatment,” says the FDA's Robert Temple. CROs wash their hands of the entire affair. “It has to do with the commitments the companies can make, which varies from trial to trial,” says Wurzlemann, adding, tepidly, that “it is a matter of concern among everyone.”
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Academic researchers are among the most reluctant to fulfill such obligations. Jay Brooks Jackson is one of the best-funded researchers at Johns Hopkins University. “We ship tons of stuff every week” to clinical sites overseas, he says. “Test kits, reagents, software, I mean it is just endless, it is endless.” But Jackson does not provide antiretroviral drugs to the patients in his prevention studies who become infected with HIV while he is studying them. “We refer them for symptomatic care and that sort of thing; it is sort of like what you would do in 1985 [in the United States]. . . . Over time, when you've worked in these countries, you just realize that this is sort of the way it is,” he says.
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Academic researchers worry that if they insist on providing study drugs to the subjects of their trials, their funders will lose interest in footing the bill for the trial. They also contend that promising patients drugs after trials end might be too good of a deal: patients would throw caution to the winds and join the trial regardless of the risks. Better, in that case, not to make any promises. “Only governments can provide long-term care guarantees,” AIDS vaccine researcher and advocate Seth Berkley argued.
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Anyway, FDA officials, CRO execs, and industry researchers who run trials abroad argue, just looking at the potential benefits of the drug in a trial is too simplistic a way to evaluate all the benefits that might accrue to the participants and their society from taking on a clinical trial. Even when experimental subjects don't benefit from the study drug, they likely benefit from the extra medical attention they'd be bound to receive in a trial aimed at getting a drug approved by the FDA. “You see, patients are very cared for in trials,” said Nadeem Rais, a diabetes specialist who conducts industry trials in Mumbai, India. And these medical services are not only free; in many trials, subjects are even paid to participate.
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A 1999 study, for instance, found that patients enrolled in randomized controlled clinical trials survive better and with fewer complications than those getting care outside research protocols.
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“Companies need to do clinical trials in developing countries, because the trials bring benefits to the patients,” says HIV
researcher Arthur Ammann, who has tried to convince companies to do more trials in developing countries. “They get special attention. . . . And they provide potential therapy for those patients.”
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“Patients who go into these trials are getting really, really good care,” said Macé Schuurmans, a lung specialist who has conducted industry trials in Switzerland and at South Africa's Stellenbosch University. He says his South African patients are very grateful to him for conducting these trials on them. “In an affluent country, you give the patient the best treatment you know of, and it is usually available. Here, [in South Africa], you have to decide if you can do five chemotherapies, and you've got twenty patients. Which five will get that chemotherapy? . . . If you see the queues in hospitals . . . they'll wait the whole day. People go there, they cough, and maybe cross-infect themselves. They have to wait to see the doctor, they have to queue to get the medicines. [But if they get into an industry trial], if they wait for the doctor at all, they get tea, they get to look at television and it is quite nice. . . . The patient is really very happy. They say, ‘Gosh, I'm really happy this happened to me.'”
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There are intangible benefits that accrue to the facility running the trial, too, which may eventually help local patients in other ways, Schuurmans and others say. Sometimes poorly equipped clinics will get a new machine or two for use during the trial and to keep afterward. Clinicians might get specialized training that they can later use to treat patients. During its Trovan test, Pfizer upgraded facilities at Kano Infectious Disease Hospital with high-tech equipment.
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The company even doubled one lab technician's salary for helping with the trial, the
Washington Post
reported.
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“It generates quite a lot of hard-earned money,” says Schuurmans, money that can be used to treat patients or conduct public health–oriented research.
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“We got some equipment, and they didn't ask for it back,” after an industry-sponsored trial ended, says Mumbai-based cardiologist Yash Lokhandwala. “Per patient recruited for the trial, they give a sum that goes to the hospital; it is, like, 15,000 rupees per patient, so if you get one hundred
patients, that comes to fifteen lakhs of rupees [around $33,000] for the hospital.”
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Doctors and nurses might learn about cutting-edge new drugs and the latest techniques. After all, “distribution of wealth and knowledge is unequal,” Wurzlemann, the CRO doc, said. “Sharing that knowledge helps make the world more fair.” It is unlikely that American doctors and patients would tolerate such trade-offs, but elsewhere clinicians profess gratitude. The placebo-controlled trial of nitazoxanide, which resulted in thirteen deaths in Lusaka's University Teaching Hospital in 2000–2001 and failed to ensure a later supply of an approved drug, “was a good experience for Zambia,” affirmed University Teaching Hospital clinician Mary Ngoma.
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For others, a few token machines and payments do not always compensate for the diversion of precious health care resources away from treating patients. Lokhandwala conducted clinical trials for multinational drug companies while working at an over-burdened public hospital in Mumbai. He recalls: “For these trials, everything has to be maintained, documented, kept in the cupboard for three years. The fridge has to be maintained at the same temperature. If the temperature goes a little bit more or less, you have to immediately alert them, and you have to stop the trials until the repairman comes, and so on. Suppose you break an ampule, you have to keep that broken part, to make sure you keep it for the study monitors to show that you had two or three. Who is going to do all this? I had my usual duties and, in addition, this trial was a big headache for me. . . . Here in clinical work everyone is overworked, and then you tell someone to spend their time on paperwork!”
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Clearly, reading the scale on risks and benefits is no straightforward task. It depends on whom you ask, when, and in what context. “The idea that one can pronounce on the ethics of something today and that will be correct forever,” says Benatar, “would seem to suggest that ethics is like a cookery book. If you want to make cookies, you can make them with a recipe and they will
always look and taste the same. The ethics of international research are infinitely more complicated than that.”
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The clinical research establishment manages the complexity by essentially leaving it to the experts. “There is sensitivity in some parts around who can speak on ethical issues,” affirms South African human rights activist and physician Leslie London. The general idea is that the appropriate venue for discussing risks and benefits of clinical trials is not the front page but cloistered ethics-committee meeting rooms and the pages of academic journals, where bioethicists and researchers delve into the complexities of a single trial at a time. It's a piecemeal, microscopic approach that isn't particularly well-equipped to grapple with how trials, in the aggregate, may exploit subjects' poverty, undermine human rights, or misallocate resources. “You get sort of ‘well you balance this and you balance that and this is important,'” says London.

“And you never get a straight answer.”
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Listen long enough to biomedical researchers, as I recently did at a multidisciplinary scientific conference, and you will doubtless hear admiring commentary about human experiments of days past, when daring trials free of onerous regulation produced spectacular results. Such experimentation, the research scientist will say, is unfortunately no longer possible “due to ethical concerns.”

Due to ethical concerns
. I heard the phrase at least a few times over the course of a single week-long conference. It is an interesting construction, which seems to be almost exclusively reserved for biomedical transgressions. It's hard to imagine anyone talking about indentured labor, or oil spills, or corporate embezzlement as not being possible “due to ethical concerns.” Those things are simply considered morally wrong and socially illegitimate, and are punishable by law. But when clinical researchers deceive patients, exploit their poverty, or divert scarce resources away from their care, it isn't considered an unalloyed bad. The main business of medical research—improving health, saving lives—overshadows it. The exploitation and human rights violations are just side effects.