Pills! Placebos! Payoffs!
The body is a temple. But there's no reason it can't double as a perfectly adequate for-profit research facility.Take Jessica Karasek, a University of Pittsburgh junior who hopes to become a physical therapist. How does she manage to make ends meet? Well, she's a healthy specimen, and she utilizes this asset. On a regular basis, Jessica rents herself out to help ensure that certain pharmaceuticals will be safe for use by other humans. Tipped off by local newspaper ads seeking subjects for such studies, she started when she was a freshman. A regular destination was a place called Novum, where Jessica tried out hydrocortisone skin cream. After a preliminary health screening, Jessica would show up on a Friday evening at Novum's headquarters, get some cream put on her arm, and then hang out all weekend with other subjects while medical people monitored her skin tone. She slept in a bunk bed and lounged on the couches in a big living area, with its pool table and her meals brought in. "All we did was watch videos all day," Jessica says. "I used to do that every month my freshman and sophomore year," says Jessica. "It paid my rent all two years." The take: $170.Since then, business has only gotten better. The best deal was a cold study conducted this past spring by Children's Hospital. Jessica and about 60 other subjects, mostly students, were put up in a hotel and infected with an upper respiratory virus. All they had to do for seven days -- school was out, so it was no problem -- was blow their noses and save the tissues so researchers could weigh them. As Jessica remembers it, they were technically all quarantined, but nobody actually got very sick. Subjects could visit one another's rooms; drinking was not forbidden. "It was really fun. It was just a blast," says Jessica. "By the end of the study we were having parties ... We got a couple of the doctors drunk. I'd do it again in a heartbeat." The take: $800.For enterprising young people like Jessica, the opportunities are endless. There's been a psychological study at the VA Medical Center: $110 for eight hours of playing computer games. There was even a couple hundred bucks for study at Western Psychiatric Hospital where all you had to do was sleep. Jessica estimates she makes up to $2,500 a year hanging around labs. Her roommates are doing it, too, and so is her boyfriend. Once, when she told her dad she was considering a study that would require five blood draws an hour, he gave her the money so she wouldn't have to do it. The take: $300. Jessica knows of many other students who share her enthusiasm for this sort of scientific endeavor -- including her roommates and her boyfriend -- and leaves little doubt it beats life in the fast-food lane. "It's better than working," she says. "I could make a living off this if I didn't have other things to do." Guinea-pigging is big business. The pharmaceuticals industry is huge and lucrative, and every product it develops must pass U.S. Food and Drug Administration muster before it can go on the market. For new drugs and medical devices and procedures, people studies are preceded by animal studies: according to the government, for instance, in 1995 precisely 333,370 actual, four-legged guinea pigs were subjected to biomedical research. No comprehensive records, however, are kept on how many humans had the same privilege."It's majorly enormous" is how Bob Helms describes the human guinea pig field. "It's hundreds of thousands of people." Helms, a Philadelphia-based guinea pig, keeps an eye on the industry through his self-published 'zine, Guinea Pig Zero: A Journal for Human Pharmaceutical Research Subjects.. Practicing or aspiring guinea pigs learn of opportunities through newspaper ads and word-of-mouth. In Pittsburgh, they ply their trade at research hospitals (especially those in the University of Pittsburgh Medical Center family) and a handful of privately run facilities including Novum, Inc. and Clinical Studies, Ltd.Studies range from low-paying multiple short visits to lengthy, uninterrupted stays of several weeks paying thousands of dollars. Researchers usually want subjects ages 18 and older, with opportunities petering out for those past 40. Helms says only a tiny minority of subjects actually guinea-pig professionally. But in his three years of pigging out, he's seen a wide range of volunteers. One segment includes "very interesting, intelligent people" who live frugally on odd jobs and guinea-pigging. "They'll just be living pretty much out of a knapsack to get out of the rent cycle," says Helms. Another group, more economically desperate, seems to have less choice. Helms classifies them as "not necessarily insane, but not major achievers. Kind of on a dead-end track. I've met a lot of them."Mr. X does not want his name published. He is an administrator at Pitt, in his early 40s, who first guinea-pigged some 20 years ago, undergoing an early testing of ultrasound technology. Researchers ran a catheter through his arm to his heart. "That was pretty insane," says Mr. X. (The take: $125.) He didn't volunteer again for another eight or nine years, but now averages $400 to $500 annually as a creature of the lab. He peaked a couple of years ago, at $1,100, when he did the Children's Hospital's cold study, but he didn't have nearly as much fun as Jennifer Karasek. "I never get sick, but I got sick. I got a cold," says Mr. X. "I had to stay in a Holiday Inn, and that wasn't any fun either."Because he works full-time, he can't participate in as many studies as he'd like. But the extra money, which is handy at Christmas and when bills come due, is enough to induce him to use vacation time for the occasional longer study. In fact, he used one Christmas break to participate in a sleep-deprivation study. But there are all sorts of benefits. "You do get a lot of physicals," says Mr. X. "I can say for a fact there's probably nothing wrong with me in terms of anything major." Mr. X also enjoys the community of his fellows. "It's sort of like a clique of people that do this all the time." He knows of some who guinea-pig for a living, traveling to other states. A certain camaraderie can develop with the researchers, who'll actively recruit reliable -- and reliably drug-free -- volunteers, and who themselves become familiar faces. "You get to know the nurses. You know, 'She's good, she's gonna find a vein right away.'"While many studies are "plain old boring," some are also unpleasant. A muscle biopsy, for instance, hurts. (The take: $200.) Other procedures are less troublesome than you'd think. "I've had a spinal tap done. But that was like nothing," says Mr. X. "I don't think I even noticed them doing it." And while he was initially worried about needle sticks, "Now I don't even think about it." Despite this inurement, he worries sometimes about having guinea-pigged for so long, especially in the drug studies. He knows each study is low-risk, but believes there might be a cumulative impact. "Even nurses who work in these places say you don't want to do too many of these things," says Mr. X. Like any old pro, he's become more circumspect. "After a while, you evaluate the money versus what they're going to do to you," he says. "There's certain experiments you'll do and certain ones you won't." And while his brother knows about his contributions to science -- along with friends who have gone on to their own lab careers -- another thing Mr. X won't do is tell his mom. She might take it the wrong way. "Most people think I'm pretty crazy."Before participating in a study, a guinea pig must sign a document acknowledging his or her "informed consent." This principle is derived from the Nuremberg Code and from federal rules enacted after the 1974 disclosure of the infamous Tuskeegee study, in which the U.S. government withheld treatment for a group of black men with syphilis in Alabama, without their knowledge. "Informed consent" means subjects must be told what a study involves, including risks (such as side effects) and potential benefits, and that as volunteers (whether paid or unpaid), they have the right to withdraw at any timeOr at least, that's the way it's supposed to work. Over the past decade or so, the medical testing that was once solely the province of universities has not only grown, but also moved into the private sector. Thanks to loopholes in federal law, privately funded research is not bound by the same rules. "There is unchecked human experimentation taking place," Dr. Gary B. Ellis, director of the Federal Office for Protection from Research Risks, says in the May 14, 1997, New York Times. In some cases, test subjects and their families have attributed death and disability to alleged research abuses, but had no recourse to criminal sanction. "It's dramatically underregulated," says Bob Helms of Guinea Pig Zero "The laws do not even come down on [researchers] unless they defraud the sponsoring company and give them bad information on purpose."By federal law, human research studies must be reviewed and approved by an Institutional Review Board (IRB), an ethics committee designed to ensure the rights of subjects, including informed consent. Some express concern that anyone can set up an IRB, and that some IRBs are run as for-profit ventures. Dennis Swanson, administrative vice chair of Pitt's IRB, oversees approval of up to 3,000 human research studies annually (not all of which are carried out).Swanson says the problem isn't so-called commercial IRB's -- he served for two years on Novum's IRB, and says, "I think they do a good job" -- but that there are two distinct sets of rules: one that applies to federally funded research, and another for everything else. Research (like Pitt's) that receives federal funds must have a locally based IRB, which Swanson says is preferable; studies not receiving federal funds can have an IRB anywhere in the country. "There ought to be one set of standards," he says.Long before most of today's guinea pigs were born, back in the 1950s, Charlotte Love was doing psychology experiments. She liked it. "It's an escape, it's like marijuana," says Charlotte, who's 74. "You get paid for it." Charlotte is married, with two adult children, and has spent the past 18 years working as a secretary for the Pittsburgh Public Schools. She volunteers at the Jewish Community Center in her Squirrel Hill neighborhood; she guinea-pigs for fun and health benefits as well as profit. "The stuff I did on medical experiments, it would cost you $5,000." One study on macular degeneration scored her a free eye checkup. "It's fantastic." She adds, "I have a picture of my spine that's unbelievable." Other freebies included peppy little pills. "I like the vitamins they give you. They're like the fountain of youth," she says. "I told them, 'These pills are great.'"While Charlotte's age makes her perfect for some studies, like one at UPMC that looked at senior's cardio-vascular health, it disqualifies her from others. So she's not picky: She's done so many she can't remember them all in detail. "I put stuff up my nose I remember for something." "Any research [advertised] in the paper, I do," says Charlotte. "If somebody wants it and I can help, I'll do it." She especially enjoyed an Alzheimer's study at Carnegie Mellon University where she was tested on her memory of flash cards. "I've got that number stuff down pat. I've done it so many times." Charlotte, who also earns money baby-sitting, recruits other seniors as guinea pigs and seems to especially enjoy the social aspect of medical research. One polyp study gave her the opportunity to join in group meetings where she learned all about nutrition. In general, she gives the impression that life as a guinea pig could not be better for her health. Even the potential side effects of pharmaceuticals don't worry her. Her husband (who's done a sleep study himself) doesn't like her taking extraneous drugs, but Charlotte says, "I don't care, I'm my own person."Bob Helms -- "Guinea Pig Zero" is his sometime nom de plume as well as the name of his 'zine -- acknowledges the creepy, science-fictional quality of people willingly selling themselves for medical testing. "It is weird," says Helms, who makes most of his living by painting houses when he isn't guinea-pigging or working on his 'zine. "Nothing I could ever say about it could stop it from being weird to most people." But Helms, a former professional labor organizer, views guinea-pigging as respectable employment, and he started the 'zine in part to document the work-culture of human lab rats. "It's easier than a lot of jobs you could compare with it," says Helms, who's been pigging for three years. "Usually you're just sitting around watching a video or reading, or on the phone conducting business ... If you want to earn money as a guinea pig [you can] do something else, as long as it doesn't require your body to be somewhere else." In today's low-wage, service-based economy, you'd think there'd be lots of people -- men, mostly, though there's an increasing number of studies open to women -- clamoring for this kind of work. Helms says you'd be right. "Now it's a lot more competitive," he says. "There's a lot of guys trying to get onto the good studies."Jeff McClung had high blood pressure all his life, and for the past two-and-a-half years the drug he'd been taking to control it wasn't working. Billboards and newspaper ads addressed to people with his condition led him to The Western Pennsylvania Hospital, where he signed up for a study where he'd take two blood-pressure drugs, not yet on the market, in combination. Jeff, who's 38 and works in a group home for the mentally retarded, didn't know whether the pills he was taking were placebos. Apparently they weren't; McClung's blood pressure stabilized, and he's been on the meds permanently for a year. During the first part of the study, he had to report to the hospital every few weeks for an hour or so; now he only goes every couple of months. (The take: $550 for two years.) Jeff, of Wilkinsburg, has nothing but kind words for the researchers. "The people there have been very helpful and very nice," he says.Guinea Pig Zero stirred up a fuss in Lab Land recently when excerpts from its "report cards" critical of Philadelphia research facilities were reprinted in the July 1997 Harper's magazine. In part, the report cards criticized Allegheny-Medical College of Pennsylvania (whose parent company owns Pittsburgh's Allegheny General Hospital) for lapses in informed-consent procedure. The hospital made national news when it demanded that Harper's withhold distribution of the issue, and the incident continues to reverberate in the research community. UPMC spokesperson Amy Kemp, in telling City Paper she couldn't locate a researcher who was willing to be interviewed for this article, partly blamed "the 'zine," saying, "It's been difficult getting someone to speak."The report cards are typical of editor Bob Helms's candid approach, which includes headlines such as "How the FDA Creates a Butcher-Friendly Research Environment." Helms doesn't hesitate to publish the names (and sometimes addresses and phone numbers) of research doctors he claims have done wrong by guinea pigs. He also takes on the issue of impoverished guinea pigs who volunteer for studies seeking free treatment for their ailments and wind up getting placebos: they may end up worse than they started. In his June 1997 issue, Helms reports that French law deals much more harshly with doctors who violate the human rights of research volunteers. In Congress, there's a movement afoot to toughen protections for research subjects, but Helms is skeptical it would counter the big money and influence of the research industry. "If [research] were any safer, it would start interfering with the researchers' business interests." Guinea Pig Zero has grown to more than 100 subscribers, including guinea pigs, nurses and researchers, and Helms -- who says he's lately been contacted by filmmakers interested in the guinea-pig phenomenon -- has less time for actual guinea-pigging. But his mission remains clear. "I'm just trying to value and demand respect for people who do it," he says. "The scientific process happens in our bodies, and that's our contribution."In July, Amy Manos was a 24-year-old nursing school graduate preparing to take her boards. The guinea pig life had beckoned a year before, when she did a Children's Hospital quit-smoking study that required carrying a beeper and call in to answer 10 questions about your habits and emotions each time it beeped. Amy, not fully accustomed to the rigors of research, lasted a week. "I got kicked out because I didn't answer all my beeps," she says, and one day accidentally left home without her beeper. The take: $50 (partial payment).But Amy persevered. A study to test insulin levels in nondiabetics required up to seven IV sticks nightly. (The take: $100 a night) Once, she rounded out a "normal brain" control group for a study about schizophrenics, making two trips on two separate days to wear electrodes on her head for a couple hours each time. (The take: $160.) Twice, she joined a 6-month-long Pitt study that required her to keep a journal detailing her sexual experiences: "You know, how it was and all that stuff." (The take: about $350 per study.) One July night, on the very eve of her nursing boards, Amy was weighing a study on whether adults immunized as children were still resistant to whooping cough. The study required injection with the virus, and Amy was "a little bit worried ... But I'm so broke right now." (The potential take: $75 a visit.)However, Amy passed her boards, and did just one more study -- an eight-hour assignment involving drugs that affect the liver (the take: $100) -- and soon after found work as a nurse. At Children's Hospital. Are there any more lab days and lab nights in her future? "No way," says Amy. "I have a good job now. Forget that."Bill O'Driscoll is City Paper's staff reporter. In 1992 he participated in an ulcer-medication study that required four overnight stays and dozens of blood draws. The take: $600.