• April 18, 2014

Inside the Risky World of Drug-Trial 'Guinea Pigs'

Human volunteers in university research may not realize the dangers they face, an anthropologist has found

Inside the Risky World of Drug-Trial 'Guinea Pigs' 2

Sarah Bones for The Chronicle

Roberto Abadie, an anthropologist who studies human volunteers in drug research, at Thomas Jefferson University Hospital, in Philadelphia, where some of his subjects volunteer.

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."

Comments

1. darkroomjames - July 12, 2010 at 11:24 am

Darkroomjames 11:13am 7/12/10

On the TV series "House", a long term multiple drug-trial subject
had complications due to a "bezore" (phonetic spelling) that was spitting out small amounts of partially-dissolved pills from previous drug trials.

Of course the biggest risks of a person who compromises the temple of the soul (the body) are the various and possible threats to one's future health, and even to one's future intentional or unintentional offspring.

An inferiority complex that allows a kamakaze disregard for one's safety and quality of life is a form of pseudo-suicide with a nobility bullet, the nobility bullet being the promise of taking a bullet so that someone else doesn't have to. Of course, all teenagers and young adults have much to be humble about until they acheive a good education or worthy experience wisdom. Any lasting damage from a drug study can scar them for life, if not accidentally kill them.

Inferiority complexes don't last forever, and indeed, the loss of one's inferiority complex is what marks the beginning of one's happiness or sense of accomplishment in life.

2. ellenhunt - July 12, 2010 at 05:04 pm

Bezoar. It's an undigestible mass. Most commonly in humans, it's primarily hair that gets stuck in the stomach. Some people that eat hair have had huge bezoars removed.

Following protocol is not enough. What is really important is that there be mechanisms for grad students, post-docs and others working on a trial to voice their concerns that is NOT under the control of the university of institution running the trial. Usually someone has a clue there are problems, most often several people, but those are not listened to because of the medieval heirarchical organization of medical research.

A more egregious case is the Jolee Mohr death. I have studied the materials and I am quite certain it was the therapy that killed her, and that this is so obvious any good immunology grad student should be able to explain it.

The problem is not just death, the problem is the coverups that happen afterward. We are having a lot of them.

3. performance_expert2 - July 12, 2010 at 08:50 pm

I volunteers for a drug study, no compensation. In retrospect, the support side of the experiement was de-emphasized. For me, the drug trial experiment went wrong and I got very unexpected side effects and was, in effect, sick. I called for help but it was not to the drug study which was one person in an office. I am certain we all know the likelyhood of successful unscheduled calling one person in an office. I turned to a health professional I knew for help. They immediately took charge and instructed me what to do, including drinking lots of gatorade to try and flush the drug out of my system. (?) For me the study ended with me providing feedback of my experience however I received no immediate help from the study when things went badly.

I am suggesting it is possible to require or otherwise regulate a clearly stated method to support the study participant when things go badly. As far as I could tell, for practical purposes I was on my own. I guess I could have gone to an ER or called an ambulance but this was not addressed in the drug study from a very professional person in a very professional office / building at a very professional medical university.

4. jenniferbard - July 13, 2010 at 01:54 pm

I'm a law professor writing about dangers to human subjects in drug trials and ways to reduce them. If anyone wants to share anecdotes or stories of what happened to the them with me I'd be happy to hear them.
Sincerely,
Jennifer Bard
Professor of Law
Texas Tech University School of Law
Jennifer.Bard@ttu.edu

5. rodriguezfeo - July 14, 2010 at 06:06 pm

Does Dr. Abadie have information concerning non consensual experimentation that goes on here in the US? The cases of interrogation and torture in Guantanamo indicate that MK Ultra type subprojects continued after they were supposedly abandoned in the 1970s.

The internet is filled with disinformation about these projects - they fill the bill of grand conspiracy theories. It seems that a lot of the disinformation posted is intentional. In addition, there has been a focus on "Manchurian Candidate" or RSA which leaves out the fact that most of the experimentation was along the lines of "behavior modification" (some use the more exotic term, "Mind Control") and interrogation.

There are lucid sites describing the use of directed energy weapons, microwave weapons and psychological harassment on innocent persons here and abroad. This might be non consensual experimentation (expecially in the cases where there is a great degree of social engineering in addition to the harassment). We won't know what it is or who is behind it/involved until someone properly investigates. Most of the victims today do not fit the bill of a schizophrenic claiming the CIA is transmitting signals via a tooth implant and some of the victims have collected various forms of evidence for their harassment.

Why haven't these cases been investigated? We know that the technologies exist, but how will we ever prove they are being deployed? If we should be horrified at the negative effects of "consenting" experimentees, what will be the reaction be to innocent citizens' non consensual and life threatening experimentation?

My internet itself is hacked and sometimes censored so it's hard for me to look into it properly. Also, this isn't really my area of research. Hopefully someone will step up to the plate.

6. performance_expert2 - July 14, 2010 at 11:49 pm

#5., Regarding the state pharmacologically abusing people, please look up "Cipro injury." Federal workers were ordered to take this drug as a "preventitive."

If anyone at CHE is flinching about covering these topics, you better straighten up and start caring about things directly around you. There is no need to restrict the discussion addressing abuses from big power. Here at CHE is an important forum for professionals to communicate in an interactive environment different than single-direction commercial media. I saw a cartoon stating "Truth is No Defense!" You get the idea.

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