But HIVNET 012 was certainly flawed; NIH itself acknowledges as much. In 2004, the agency therefore requested an evaluation of the trial results from the Institute of Medicine (IOM), an independent, quasi–academic body that advises government agencies and researchers. The IOM concluded that HIVNET 012’s conclusions were valid. It agreed that investigators’ files had been messy (in part because the hospital in Kampala flooded during the investigation) and that some adverse events had gone unreported (both in patients taking nevirapine and in those taking AZT). But the IOM determined that the data on rates of HIV infection and survival did indicate the benefit of the nevira-pine regimen to the newborns.
In any case, HIVNET 012’s flaws are not relevant. At least five other studies have now confirmed the safety and benefits of the drug. Indeed, as a group of renowned AIDS experts, including Robert Gallo, the codiscoverer of the HIV virus, wrote recently in response to Farber’s article, “Not a single life-threatening event related to short-course nevirapine has been recorded in mother or child in tens of thousands of such uses around the world.” Ultimately, Farber’s contentions are skewed by her assumptions. To someone who believes HIV is benign, what would be a good anti-HIV drug or trial?
Jennifer Kahn’s Wired story poses different and less easily answered questions about clinical trials in the poor world. Her account of drug trials in India indulges in its own kind of excess: she claims that “India, the brilliant hub of outsourced labor, was positioning itself in a newly lucrative role: guinea pig to the world.” But Kahn’s piece is genuinely thought-provoking. It profiles a quiet doctor named S. P. Kalantri who works in Sevagram, a town in the -middle of India, in order to ask whether clinical trials in the poor world are inescapably morally compromised.
Kalantri explains that he and his hospital are receiving a growing number of requests from pharmaceutical companies looking for test sites for drugs in their development pipelines. On the one hand, he notes, impoverished patients enrolling in these trials can receive a “health care windfall,” including regular physical exams and access to medication that may help them. But the problem, Kalantri says, is that patients are often quite passive and tend not to question their doctors’ recommendations, making it harder to ensure uncoerced, informed consent. And regrettably, the drugs being tested in India often have little relevance to their recipients’ most pressing medical problems. For instance, -Kalantri’s hospital is currently part of a trial to determine whether a drug called Aggrenox can help to forestall second strokes. Arguably, many other potential thera-pies would be more helpful to the people of Sevagram. And even those that are helpful may turn out to be too expensive for them.
In “A Nation of Guinea Pigs,” Kahn worries that payments to hospitals and doctors, which are meant to cover the costs of running and overseeing a trial, sometimes serve as bribes, encouraging improper human experimentation. She questions whether trials in remote areas receive proper oversight, from either the Indian government or foreign institutions. (Indeed, pharmaceutical trials that do not receive government funding are overseen by commercial institutional review boards, which are paid by the companies they are supposed to be monitoring – an obvious conflict of interest.) Kahn does not demonstrate specific wrongdoing or scandal. But she clearly explains the perverse incentives that might encourage unethical behavior.