Why do some people volunteer for clinical trials? Are they aware of the risks? Are they treated properly? What kind of follow up should take place? These are among the issues that Roberto Abadie, a visiting scholar in the health-sciences program at the Graduate Center of the City University of New York and a PhD in anthropology, explored in a new book, ‘The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects.’ He would like to see Phase 1 volunteers be recognized legally as workers, which would offer them protection under labor laws. And he favors the creation of a national registry of Phase 1-trial participants, which prevent people from participating in too many trials and help researchers identify long-term adverse effects associated with certain trials. We chatted with Abadie about his thoughts and observations…

Pharmalot: Why did you pursue this?
Abadie: I think it was 2001. There was a young volunteer for a Phase I asthma study at Johns Hopkins and she got seriously, went into a coma and she dies. That got me thinking about how much we knew about risk, how much we care, issues of financial compensation. I was just beginning to go for my Phd and thinking about my research. And I realized anthropologistss and social scientists didn’t know anything about healthy paid subjects and drug safety in trials in America. Who are they? What are there motivations? We didnt’ know how they think about the trials and the risks involved or how much they care about the trials. My big question was since they are paid – maybe $300 or $400 a day for a trial that may last a couple of weeks or more – do we have any idea how money influenced their understanding of the risks and what that means for the entire process?

Pharmalot: So you went to Philadelphia and then what?
Abadie: I went there because It’s a hotbed of clinical trial activity. Glaxo shutdown then, but AstraZeneca opened. Wyeth, Merck, Bristol-Myers were there as well. And some small companies, most of these people volunteer for the big ones. And you have the med schools – Penn, Thomas Jefferson. Those are the main ones. And there are a lot of people who are willing partipicants. It’s a big city with a lot of poverty. I was there in 2003 and 2004. There’s a website called Guineapigzero.com that was started by Bob Helms and it’s because it shows experiences and views and voices from the guinea pigs. He introduced me to people and I lived with one professional subject and that was great, because I could follow him. I would go to the trial site with him, his name was Michael. I couldn’t enter the facility. I’d just wait outside and ask questions – What did you take? How did it feel? They all told me the same thing – it’s very boring. There are frequent blood draws for toxicity. Sometimes, urine tests. The facilities look like hospital rooms…

Pharmalot: You used the word ‘professional’ to describe them. Why?
Abadie: Money. Until the ‘70’s, trials were done on prisoners – they were convenient, and they were paid to do it. But in the ‘70’s, people started worrying about issues of consent, so the practice was outlawed. Industry now had this problem. They couldn’t shut down their pipelines and move to China or Mexico. They had to find new volunteers. So they put ads in papers…Anyway, they call themselves professional guinea pigs. They feel it’s their job and the clinical trial is a business. That’s how they talk about it – I’m an independent contractor wit h the industry. And they may do it for a living, although they do other things on the side – messengers, painting, construction. They just move back and forth between jobs and clinical trials. They become addicted to the easy money. They’re supposed to pay taxes, by the way, but they don’t. And some people (interviewed) did 80 to 100 trials, even more in maybe five. Most probably do eight to 10 a year. And there was a lot of competition among trial sties for volunteers.

Pharmalot: Is it really that easy for them?
Abadie: They tell me different things. Some say it’s like a vacation. Some say it’s better than working at a McDonalds. Excepts for the pills and blood draws, it’s like a vacation. But others call it a mild torture economy. They staff doesn’t care about them, that it’s dehumanizing, the orders you have to follow. They complain about the bad things they see, maybe conditions, painful blood draws. But they also tell me there’s involved in everything. They think most trials are not very risky – there’s a moderate risk level. They do fear psychotropic drug trials. They think these are riskier than others.

Pharmalot: Which ones did they like?
Abadie: Painkillers and acid reflux and gastritis and artrithis….Drugs already on the market…They don’t like HIV or cancer drugs because they feel these are very toxic….But there are so many trials, they can afford to choose..

Pharmalot: Did you see anyone seriously harmed?
Abadie: Serious side effects are actually very rare. They don’t happen every day. So in that sense, they may be right that it’s easy money. I became aware of maybe 20 instances over one year. Some fainted during a trial, maybe someone had low blood pressure. But there is potential for abuse, taking advantage of some participants. I know because some cases elsewhere made it into the press, cases where poor, homeless people had been recruited into clinical trials…In this economy today, the issue is about how volunteers are recruited, paid, the compliance. I used it as a lens to describe and reflect on situation of professional paid subjects in the US.

Pharmalot: What do the volunteers think of the drugmakers?
Abadie: I talked to them about the industry and trust and the results. Some don’t care. Sometimes, someone would take food into the trials or don’t’ always take the med. They’ll say ‘we don’t trust the industry and we don’t care. If something comes of it, we don’t care, but this is our job and we do whatever to get in and stay in the trials. But generally, there’s not too much they can do to mess with the data, because there are blood draws.

Pharmalot: Why create a registry?
Abadie: We need to know who they are, how often do they enroll, frequency of participation… For instance, they’re supposed to wait 30 days between trials in case of side effects…A trial registry has nothing to do with access to medical records. It’s just recording the trial site, the place, the date, the length of participation, the drug tested, expected side effects and any actual adverse reactions. Knowing more about the participants would help the industry – if you have people doing multiple trials and don’t have a track record, it may challenge the integrity or validity of the data…But my concern is mostly with volunteers – protect them from doing more trials than they should be doing.

The ethics really worries me. Money is used to ensure compliance, but participation is supposed to be free and uncoerced The assumption is they’re free to leave at any time, but the way industry uses money is really coercive. Sa a trial has two legs and there’s a break of two weeks. They don’t pay half now and half later. They want to make sure you finish, so they pay at the end. I find that problematic.

But there are no easy answers, because we need to test drug safety and somebody has to do it. We can’t just go from an animal model to humans. And people won’t do these things out of the goodness of their hearts. What we have now is not perfect, but my recommendations are pragmatic. What I want to do is make sure protections and oversight are in place and they have the best deal possible and a centralized registry would help. I worry about a person many years later after they’ve quit trials and what we don’t know about the long term toxicity and the effects of being a professional subject. We should do research. It would be expensive and a long-term project, but it’s a serious question and we owe it to them.