- BIOETHICS FORUM ESSAY
Tracking Professional Guinea Pigs
More than ten years ago I was an occasional guinea pig testing drugs for money in Canada. The industry ads looking for young healthy males with flexible schedules willing to be “paid volunteers” were displayed everywhere on campus, city weekly magazines, buses and were even announced on radio. Their message: “financial compensation provided for your time and travel expenses.”
Unsure about whether a foreign student could join this trial economy, I held out for months but I finally called them. I went through a phone screening and later a medical checkup before enrolling. The trials were a bit uncomfortable, boring, but uneventful, and at the time I didn’t think much of them. A few years later Ellen Roche, a young healthy volunteer, died in an asthma study conducted at Johns Hopkins University. It was then that I realized that although bioethicists have been discussing the ethics of paying subjects to test drug safety, we didn’t know who the healthy paid subjects were, what motivated them or how did they made decisions about joining a trial, or the effects money had in the way they perceived and dealt with risk.
To answer these questions in 2003 to 2004 I conducted an ethnography of a group of self-defined professional guinea pigs making a living by continuously participating in the trial economy in Philadelphia, a hotbed of clinical trials activity. Financial incentives play a big role in recruiting and retaining healthy paid subjects. Usually, they volunteer in eight to ten trials a year (assuming they follow guidelines that prevent them from participating in more than one trial at a time and that they wait 30 days after the trial is over to enroll in other one). They can make up to $20,000. If they do more than one trial simultaneously or don’t wait in between trials they can make even more.
I realized that financial payment to subjects went beyond the first phase of drug development. For comparative purposes, I studied a group of HIV patients testing different drugs or drug regimes in Phases II and III. While money was important to them, they volunteered to gain knowledge about disease, track the virus load and take an active participation in their treatment. These trials can last for years and involve monthly or even more spaced visits. Every visit patients would receive a bus token or two and around $30.
One focus of my research was the informed consent form and process because it is the main way in which prospective research subjects are informed of the goals, risks, and benefits of the trial they intend to join. I followed professional guinea pigs doing drug safety trials to their trial appointments, read the informed consent form with them right after they had signed it, and asked questions throughout the trial about their experiences.
Professional guinea pigs feel that trials have only a moderate risk level because adverse drug reactions are rare and most trials involve bioequivalence tests on drugs that are already on the market. A bioequivalence drug test for a painkiller, for example, would be one of their favorites. In contrast, “first in man” trials testing new, experimental drugs are perceived as riskier, especially if they involve psychotropic drugs because they “involve the mind.”
Subjects seem to be relatively well informed of the key elements contained in the consent forms, but they are not fully aware of risks when they sign the forms. At that point they had already made the decision to enter the trial and see the consent form as something they have to get out of the way. By the end of the trial they come to understand more completely the procedures, goals, and risks. Over the years efforts have been made to improve the readability of consent forms, adapting the language to a less technical and more accessible format for lay publics. Font size and additional video or print materials have also been tested. Still, the same barriers remain.
Prospective volunteers systematically underestimate the risks and overestimate the benefits. And for all the efforts, informed consent forms still read like subprime mortgage contracts because the consent form is designed to protect research subjects but also, research institutions, the pharmaceutical industry, federal regulators, and IRB’s. It is a legal document, and that makes it very difficult to eliminate the legalese. Even if that were possible, some problems would remain. Healthy paid subjects would continue to overlook the consent form because they are convinced that risks are tolerable and because they need the money. Patients in later phases of clinical trials research would continue to have trouble making a careful, rational decision about risks and benefits because they are affected by serious and often life-threatening conditions and are in search of a trial that would deliver a “medical miracle” despite all odds.
This is not to imply that patients are irrational, but instead that they evaluate risks and benefits not in the abstract way supposed by some ethicists, scientists, and IRB’s, but in a way that takes into consideration their knowledge, disease experience, hopes and aspirations. To make things even harder, I recently learned that poor sick patients sometimes volunteer for more than one Phase II/III at a time or just one immediately after the other to maximize financial gain. This is disturbing because these patients are frequently very vulnerable and simultaneous trial participation might expose them to serious, life-threatening risk. Of course, these patients are probably unlikely to look at the consent form at all; they look mainly at the few dollars that an additional trial would bring.
The tendency for poor sick people to enroll in multiple trials is perhaps the most troubling developments of the extension of financial compensation into the therapeutic phases of clinical trials research. And since there is no centralized registry of clinical trial participants nobody knows how serious the problem is. Creating such a registry would help put this issue on the table. Implementing such a registry and banning simultaneous participation for research subjects, from Phase I to Phases II and III, would protect them more effectively while also enhancing the validity and legitimacy of trials research whose data might be otherwise compromised.
Roberto Abadie is a visiting ethnographer at City University of New York and author of the new book,The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects
Published on: October 15, 2010
Published in: Clinical Trials and Human Subjects Research