Presumably, the screening process filters out the unhealthy. "For the most part it's adequate, but it's not always thoroughly done," concedes an FDA official who requested anonymity. "The screening is very minimal."
While the FDA theoretically oversees the drug-development process from test tube to pharmacy, the highly competitive industry operates behind a veil of secrecy. In such an atmosphere, even the most basic information is jealously guarded. In refusing repeated requests to comment for this story, some clinic directors cited confidentiality agreements with their sponsors. Time conflicts were another issue, as was public perception. "There have been articles in the past and things haven't been too favorable," confides an administrator at Peninsular Testing. "Articles have used the words 'guinea pigs' and other things. It just didn't sound right."
After taking part in about 25 studies during the past half-dozen years, John Mains is ready to retire from the ranks of the human guinea pigs. Speaking by phone from South Florida Bioavailability Clinic, where he is in the midst of an experiment, he says he entered the trade "thinking it would be a good way to save money and get a nest egg together." At that he has had limited success, managing in the best of times to pull in only about $6000 annually.
Over the years, Mains has swallowed experimental aspirin, ingested a new heart medication, even helped try out a synthetic opium painkiller. He says he was once involved in a study in which clinicians "put a tube up my nose and down into my stomach. They had a little camera looking around; it was kinda rough getting in and out. It was for some kind of stomach medicine. I didn't keep really close tabs on it. Something to do with the stomach lining." His participation earned him $300 for two days' work.
During the lulls between studies, Mains would visit relatives in St. Louis, scrape together some day labor, and "try to make a go of it" A by which he means he'd seek more permanent employment and a life out of the labs. He also saw a lot of Thoroughbred racing. And inevitably, he found himself back in a clinic waiting room, paging through a consent form. "My first goal is to get a car, then get a job," he says. "I've been an accounting clerk before, but basically speaking, I've just been doing studies."
Experts in the field generally agree that the U.S. now has an adequate system for safeguarding test subjects. Mistakes and illegalities are kept in check by existing regulations, they assert, and, equally important, by a fear of costly disaster.
"The press and the political process make sure this is done in an ethical way, make sure that the regulations are stringent and applied. And these concerns are set off against monetary forces," says UM's Robert Rubin. "Drug companies are so scared about somebody getting sick and suing for $100 million -- the risk on the negative side is greater than the benefit on the positive side. They're the ultimate deep pocket, so they're scared shitless."
It's no surprise that pharmaceutical industry representatives would concur heartily. But Pharmaceutical Research and Manufacturers of America spokesman Steve Berchem goes so far as to say that many of the association's member companies are complaining that stringent FDA regulations, old and new, are forcing them to pursue their experiments elsewhere.
"Working with the FDA for phase-one trials is so burdensome and expensive that they're shifting overseas, where the research can be done in far less time and with far less paperwork," he says. At the same time, Berchem contends, increased competition has prevented pharmaceutical companies from raising prices to compensate for the higher costs of securing approval for new drugs. According to Berchem, research and development among private pharmaceutical companies is growing at its slowest rate in twenty years.
Of course, as long as experimentation -- with its attendant remuneration -- continues stateside, researchers aren't likely to lack for cooperative bodies to inject and examine. "I don't know what I'm taking," says Joe, the homeless-shelter cook, in the midst of yet another blood-pressure medication experiment. "All I know is that it's high-blood-pressure pills and I'm still alive and I'm going to get paid cash
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