There are lots of ways to make a buck, but becoming a human guinea pig for drug research has to be one of the oddest.
"We are selling our bodies, most definitely," says Paul Clough, who has taken part in more than 80 drug tests in the past 11 years. "Well, renting," might be more accurate, he concedes. Clough, who's 37, also runs a website that helps people find trials to sign up for.
Some are like the one he's doing right now, which stretches over three months and involves multiple stints living in a clinic with other volunteers, eating cafeteria food and showing up on time to get his vitals checked or to pop another pill.
"It's like summer camp," he says, then reconsiders, since in this trial he can't leave. "It's kind of like being in jail, except you don't get shanked in the shower."
Clough first heard about this line of work from a homeless man in Kansas City, Missouri or Kansas? Since then, he moved to Austin, Texas, to be closer to some of the big clinics that pay well. He says he can make thousands of dollars in just a few weeks. "Generally, the more procedures, the more perceived risk in a study, the more it's going to pay," he says.
The early tests, though usually safe, can carry unexpected hazards. In January, the test of an experimental pain drug in France was halted after several participants developed serious neurological problems. One man died.
"Every time you see a TV commercial for a drug and they rattle off all the reasons why you shouldn't take the drug — that's all information that they got from people like me," says Clough.
He may be overstating the case a bit. Larger trials of the potential new medicines in people with illnesses the drugs aim to treat are more likely to uncover a wide range of side effects, but there's no question that these early tests in humans help reveal the potential hazards of experimental medicines.
Those so-called phase 1 studies involve a small group of healthy people to determine the right dosage and to get a first look at what the side effects in humans might be. A drug that passes the first test will then move on to larger human studies where it is typically compared with a placebo or other treatment in patients suffering from the condition it's meant to help.
Clough says he'll do about eight or nine trials a year. It's enough to fund day-to-day life, plus travel. He's planning a trip to Alaska to photograph bears.
Like other serial participants in clinical trials, Clough knows that what he's doing could potentially help others down the line. But that's not the main drive for volunteers. "We need money," says Clough.
And for some people, especially those with a history of incarceration, clinical trials are a rare opportunity. "I can't get a regular job because I have a couple of legal problems in my background," he says. But when he signs up for a clinical trial, he says, "They're only looking at what your body does, not what you did."
Sociologist Jill Fisher, at the Center for Bioethics at University of North Carolina in Chapel Hill, says that's a perspective she's come across frequently in her research. She studies people who participate repeatedly in phase 1 clinical trials, including self-proclaimed professionals like Clough. "I think that says a lot about our system overall and what kind of opportunities we have for people in a period of post-incarceration," she says.
Until the 1970s, experimental medications were often tested in prisoners. Now, clinics rely on healthy volunteers, who get paid for taking the risk, typically around $200 a night spent in a facility.
For a lot of people, it's good money. But Fisher says there are a few things about phase 1 clinical research that are concerning.
For one, medical research trials in the later stages of drug development — usually involving patients who could gain something more than money from taking the experimental medication — tend not to involve enough minority participants. By contrast, in phase 1 research, she says, "The vast majority of participants are under-represented minorities." In the Northeast they're typically black men, and in the Southwest they're typically Hispanic men.
The drugs they're testing may go on to make billions of dollars for pharmaceutical companies, though the vast majority that manage pass phase 1 never make it to market.
"I am very concerned about the fact that we're using a segment of our population who might not ever be able to afford the drugs that they're part of testing, and not compensating them perhaps to the degree that we really should," she says.
Robert Biafore doesn't see it that way. He's a former car salesman who lost his job when the economy went sour in 2008. Biafore says he's participated in at least 50 trials in the last six years.
"My time will come to an end ... and I will go back to selling cars. But in the meantime, this is easy. And I'm getting full medical checks," says Biafore, who's uninsured. "Where else am I going to go and get labs done, physicals done, ECGs done, MRIs looked at and people are going to look at my body and tell me what is wrong with me before something's even wrong?"
He acknowledges that his line of work has risks. But Biafore says the worst that's happened to him was that he got a rash and vomited.
"It's all part of the game," he says. "You're letting scientists use your body to get data for clinical results, so they can get it approved by the [Food and Drug Administration]. It is what it is. You can't be afraid of it."
Every time someone picks up medicine from a pharmacy, or gets a prescription, they owe a debt to the human guinea pigs. "If it wasn't for people like us you wouldn't get that medication," Biafore says.
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