Streams

Sour Economy Increases Appeal of Drug Trials

Monday, January 05, 2009

More and more people looking for work are selling not their skills or their experience, but their bodies – to science, that is, for paid drug trials. The practice isn’t new, but it’s expanded as pharmaceutical companies have widened the quest for the next blockbuster medication. WNYC’s Fred Mogul reports.

REPORTER: Jennifer prides herself on being a self-supporting artist, not a struggling one. She owns her apartment and a very un-hip minivan. Over the last year, though . . .

JENNIFER: . . . everybody’s on TV telling people to stop buying things they don’t need. But I’m making a living selling people things they don’t need, which is art work. And so it’s a little bit of a slow time

REPORTER: So, she was more open than she might have been to a pitch by a firm called Clinilabs, which runs drug trials for pharmaceutical companies and specializes in mental and neurological conditions. At a health fair, Clinilabs tested Jennifer’s cholesterol and blood pressure.

JENNIFER: Then I saw a listing for them on Craigslist and because I had already heard of them and knew they were legitimate, I responded to them .

REPORTER: Now, Jennifer – who asked not to use her real name – will spend eight days quarantined in Clinilabs’ midtown office building, testing a possible sleep drug. When awake, She’ll do various tests to see if the medication (or placebo) has affected her. And while asleep, trial monitors will observe her brain waves, breathing and more, through electrodes she’s plugged into.

JENNIFER: I would not have agreed to do it, if you couldn’t make phone calls and have your computer and watch TV, because there’s no way I could do it, no matter how much they paid you, because I would go insane.

REPORTER: And Jennifer can walk away at any time. For three 8-day immersions, she will get 5,600 very helpful dollars. Gary Zammit, the founder and CEO of Clinilabs, says many of the drug trial participants aren’t 9-to-5 workers. They’re artists, writers, students, actors and actresses, waiters and waitresses.

ZAMMIT: More recently as unemployment has gone up we have found that people are out there who have more flexibility in their schedules. They’re also interested in the compensation that is provided in the study. So they’re calling with inquiries about the studies that we’re doing.

REPORTER: Zammit says many people participate, because they sincerely want to help advance scientific knowledge; because they want to benefit from potentially cutting-edge drug technology; because they’re uninsured and want some of the healthcare that participating in a trial provides. I talked to dozens of people who’ve done this, at Clinilabs and elsewhere, and I asked what motivated them. Most said. . . well, what you think they would . . .

VOICES:

- I needed some money...

- I have bills to pay...

- It seemed like a pretty easy way to make a significant amount of money . . .

REPORTER: Most said they were well-informed by the trial supervisors. Ruth Macklin, a bio-ethicist at Albert Einstein College of Medicine, says it’s important to keep an eye out for inducement. She and other ethicists get concerned when those who’re economically vulnerable take on higher risks.

MACKLIN: The question comes down to whether or not people who have lost their jobs are in a position to be exploited or perhaps influenced unduly to be a research subject. Is it, in fact, a risk most people would not undergo, but for the money?

REPORTER: One-time trial participant David Butanski didn’t think he was taking on an especially high risk a few years ago when he went into a four-week trial to evaluate the safety of a possible stomach ulcer drug.

BUTANSKI: I went in not so concerned, because for some reason, the stomach seemed to be kinda – whoah, I got a tough stomach. I can deal with it. I need five grand.

REPORTER: Butanski spent two weeks sequestered at an office park in New Jersey, taking the drug and staying out of the way of his more disagreeable fellow participants. He got only an hour a day outside, and nurses monitored him constantly. Butanski wrote an entire screenplay – even as he was painfully constipated for days at a time. When he returned for the next phase of the drug trial, it was aborted on the second day. Everyone got paid the full fee.

BUTANSKI: They were, like, “You signed this contract, and we promised you if we found a side effect, we weren’t prepared to see, we’d end the study, but if you want to continue, you also have that option.” And we looked at each other, and we were like, “Yeah, right!”

REPORTER: The FDA in theory oversees patient safety at these companies. But in practice, they mainly make sure firms have set up and followed ethics boards. Doug Peddicord, the head of the Association of Contract Research Organizations, says patient safety is paramount in drug trials.

PEDDICORD: They are conducted by licensed healthcare professionals, so the physicians, nurses and others are regulated in the same way as any other physician or nurse is.

REPORTER: That’s true when drug trials are conducted in hospitals, clinics and doctors’ offices – largely because state health department inspectors monitor those institutions. But self-contained drug trial centers such as Clinilabs are subject only to their own ethics panels and audits by the F.D.A. Dr. Marcia Angell says these Institutional Review Boards, or I.R.B’s, have no interest in challenging the drug companies that pay them.

ANGELL: So you have a chain of actors each of which is paid by another element in the chain. You have the drug companies paying the I.R.B’s. The conflicts of interest pervade the system.

REPORTER: Angell takes issue with firms like Clinilabs, which are part of the 15-to-20-billion-dollar Contract Research Organization industry. The former editor-in-chief of the New England Journal of Medicine and senior lecturer at Harvard says that until C.R.O.’s emerged about 20 years ago, pharmaceutical companies relied on academic medical centers to run drug trials.

ANGELL: They just gave grants to medical schools for the use of the faculty to do the research and then stepped back and hoped their drugs looked good. They didn’t have control over the design of the trials. They didn’t analyze the data. They didn’t write the papers. They didn’t tell researchers whether they could publish the papers and under what circumstances.

REPORTER: Angell says using contract research organizations lets pharmaceutical companies design studies that make their drugs look good. And they can suppress bad test results, with little or no any objection from federal law. She’d like to abolish C.R.O.’s and make drug companies once again use academic medical centers exclusively. Doug Peddicord, the head of the Association of Contract Research Organizations, says this would stymie innovation.

PEDDICORD: We think that a combination of scientific discovery and entrepreneurial drive combined with oversight by the FDA and other regulatory bodies around the world is the best path to a consumer-centered healthcare system.

REPORTER: The pharmaceutical industry can expect change from the Obama administration, concerning the future of drug testing, approval and marketing. In the meantime, given the economy, people looking for cash will continue to cruise craigslist for drug trials.

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