Frank Little (not his real name) is a 33-year-old political activist in Philadelphia. To help subsidize an itinerant life of rallies, food cooperatives, and independent publishing, Mr. Little volunteers a few times a year to participate in safety trials of new drugs. In exchange for two weeks of blood draws, boredom, and occasional side effects during these “Phase 1" trials, Mr. Little can pocket $3,000 or more.
“I try to mix it up,” Mr. Little says. “I sometimes do MRI studies and other psychology experiments, which only pay a hundred dollars or so. But two or three times a year I’ll do a Phase 1 trial, and there the payments are much higher.” (Mr. Little insisted on a pseudonym because he worries about compromising his ability to volunteer for future trials.)
Since 1980, when Phase 1 drug tests on prisoners were banned in the United States, university medical schools and pharmaceutical companies have depended on volunteers like Mr. Little to test the safety of new drugs. Bioethicists have devoted thousands of pages to debates about the system. Some fear that high payments for volunteers are an “undue inducement” that might tempt them to take risks against their better judgment. Others say that people like Mr. Little are consenting adults who are reasonably capable of assessing danger.
Most of those debates have been conducted in the abstract. But now an anthropologist has produced a study of several dozen medical volunteers, including Mr. Little. Roberto L. Abadie, a visiting scholar in the health-sciences program at the Graduate Center of the City University of New York, spent a year living in youth hostels and group houses in Philadelphia, trying to get a sense of why volunteers do what they do and how they understand their risks.
He offers his findings in The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Duke University Press, August). The book’s primary purpose is to offer a detailed description of medical volunteering and its contexts, not to weigh in on the ethics of clinical trials. But after his year in the field, Mr. Abadie does have opinions about policy: Volunteers underestimate their long-term risks, he says, and universities should do more to protect them.
“Philosophers and bioethicists are very logical, and they can construct strong arguments,” Mr. Abadie says. “But what they can’t do is to go in there and do what I did—to do an in-depth ethnographic analysis, spending weeks and months with volunteers. Knowing who they are, what their neighborhoods look like, how they go through the trials, how they think and talk about the risks they’re taking.”
A Mix of Motives
Mr. Abadie spent time with anarchist activists who are attracted to guinea-pigging because of the flexibility it offers. Between 1996 and 2002, that milieu was documented in Guinea Pig Zero, a Philadelphia zine published by and for activist medical volunteers.
But Mr. Abadie’s book also examines two other types of medical volunteer. First, he describes transient, economically struggling people who travel from place to place in search of lucrative trials. These volunteers are often less educated and more socially isolated than the anarchists.
Second, Mr. Abadie spent months at an HIV clinic where patients were participating in long-term trials to determine the effectiveness of new drug combinations. That environment is very different from the Phase 1 trials described elsewhere in the book. At the clinic, the HIV patients knew they had a personal stake in the development of new drugs, and the financial compensation they received was much smaller. Even though they were taking risks by participating in the drug studies, Mr. Abadie says, those volunteers seemed to reap psychological gains.
“They see the trials as an opportunity to empower themselves in their fight against the disease, a way to take control of their bodies and their lives,” he writes.
Mr. Abadie is more ambivalent about the wisdom of participating in Phase 1 trials. Most of the volunteers he spent time with tend to say—naïvely, in his view—that the drugs will “wash out” of their systems within a week after the experiments. That may be true in most cases, but some drugs can accumulate in the liver. There may also be unknown risks associated with participating in many trials over a lifetime.
“Almost my entire time there, volunteers said to me, ‘No, risk isn’t a problem,’” Mr. Abadie says. “It wasn’t until the end of the year that someone finally said, ‘OK, we don’t like to talk about it. Maybe it’s a coping mechanism.’”
A New Angle on Risk
People who use drugs are familiar territory to Mr. Abadie. He was born and raised in Uruguay, and he spent several years there working with heroin users at an HIV clinic before moving to Canada to study anthropology. “Throughout my life, I had been studying drug users and how they understand risk,” he says. “That’s what I thought I would do as a medical anthropologist.”
But when he entered the doctoral program at CUNY in 2001, Mr. Abadie became fascinated by the story of Ellen Roche, a staff member at the Johns Hopkins University who died while volunteering for a trial of a new asthma medication.
“When I first found this topic, I was so engaged with it that I couldn’t sleep,” he says.
Through an extended network of friends, Mr. Abadie made contact with Robert P. Helms, a self-taught historian and serial medical volunteer who was the editor of Guinea Pig Zero.
“When Roberto first came to Philadelphia, it was clear that he didn’t know very much,” Mr. Helms says. “But he’s a quick learner. He hung around, and he asked the right questions.”
Mr. Abadie would like to see Phase 1 volunteers be recognized legally as workers, bringing them under the umbrella of labor law. (Mr. Helms, an anarchist and a former labor organizer, is skeptical. “Roberto hasn’t had the horrible experiences I’ve had with American labor law,” he says.)
Mr. Abadie would also like to see the creation of a national registry of Phase 1-trial participants. A central database, he says, would prevent people from participating in too many trials, and might also help researchers identify long-term adverse effects associated with certain experiments.
Glen N. Gaulton, executive vice dean for research at the University of Pennsylvania School of Medicine, says he is open to such an idea, if it can be done efficiently and with enough privacy protections.
“Conceptually, it’s absolutely the right thing to do,” Mr. Gaulton says. “Especially in a city like Philadelphia, where there are so many medical centers. We ask subjects to disclose if they’re participating in other trials—but if someone wants to lie, I won’t necessarily know if they’re simultaneously doing a trial across town.”
But Mr. Gaulton disputes any suggestion that his university does a poor job of protecting research participants. After the death of Jesse Gelsinger, an 18-year-old patient who died during a gene-therapy experiment at Penn in 1999, the university created new systems for auditing clinical trials. “Our auditing office randomly visits trials to make sure that protocols are being followed,” he says. “Any institution that doesn’t do that is asking for trouble. The single biggest risk associated with clinical trials does not have to do with payments or volunteer recruitment, but with making sure that the experiment is actually being carried out in the way that the IRB was told it would be carried out.”
Is that really the single biggest risk? Mr. Abadie is not so sure. “I think the biggest way to reduce risks is to look at financial conflicts of interest,” he says. “When researchers have financial stakes in the outcome of a trial, that compromises safety, ethics, and the legitimacy of the entire thing.”
