For the past six months, I've been talking with guinea pigs. Two-legged guinea pigs, that is. The kind who sell their bodies to science. There are guinea-pig musicians, librarians, restaurant workers, teachers and union organizers in our midst. Some are regular recruits for studies at local universities, while others routinely offer themselves as paid volunteers for investigations by private labs.
As a quick scan of the want ads shows, the Triangle has become a major hub for aspiring scientific "volunteers" because of those private labs. Fifty-three of the state's 63 contract research organizations--firms that conduct studies for big pharmaceutical and biotechnology companies--are located in the Triangle. The size of their local work force has tripled in the last four years to an estimated 3,000.
To attract a steady supply of human guinea pigs, the industry has polished its image. With labs that look like hotel rooms and Web sites touting "friendly, courteous and professional staff," companies like Morrisville's PPD Inc. and Durham's Applied Analytical Industries have helped move guinea-pigging into the mainstream. Or closer to it.
My interest in clinical pioneers was sparked last May when federal regulators ordered a weeklong halt to research involving human subjects at Duke University. The feds had discovered that some protocols for patient safety were not being followed. The problems identified at Duke were mostly paperwork failures, although there were reports of one patient who suffered a case of decompression sickness during a NASA-sponsored study there. Overall, the lapses were serious enough to raise official eyebrows and force the university to tighten its procedures.
Duke's short-lived punishment was a dramatic move in a field that's still surprisingly unregulated. Federal safety rules cover only those studies funded by government grants--and even then, federal agencies keep no systematic tally of "adverse reactions" experienced by test subjects. That's been left to the research units themselves.
The circumstances made me curious about the habitual guinea pigs in our midst. What sort of people willingly offer themselves for experiments? And what do their experiences tell us about the dark side of progress, about what Robert Helms, a guinea-pig advocate from Philadelphia, Pa., calls "the disposability of plebeian life"?
Officials at PPD, the firm most popular with the research subjects I talked to, were of little help in finding answers. They declined to share information about the number of human test subjects they use, the type of studies they conduct or how many "adverse reactions" have occurred under the company's watch. PPD spokeswoman Nancy Zeleniak warned that she would "neither confirm nor deny the existence of any volunteer subjects who say they have worked for us" because of strict confidentiality agreements with corporate sponsors. She also made it clear that not everyone can be a guinea pig for PPD.
"Volunteers go through a rigorous screening process, a physical exam, medical history and an interview," Zeleniak said crisply. "We ascertain key factors for their inclusion or exclusion for a specific study. Those factors are set up by the sponsor."
I thought about enrolling in a study myself, but deep-seated anxieties about needles, closed doors and other aspects of scientific intervention held me back. In the end, I went the same route as the research labs--I advertised for volunteers. I offered anonymity to my subjects so they could speak freely, without fear of retaliation by companies or researchers they might describe in less-than-glowing terms. In return, I asked for details of their adventures in the field. Here, then, are some their stories.
I'm huddled at a table at Third Place coffee shop in Raleigh, nursing a cappuccino as I await the arrival of Guinea Pig J. That muscular guy with the vaguely South African accent looks promising. Or could it be the rail-thin man in the plaid shirt and jeans? My reverie is broken when a lean young man with pierced eyebrows and spiky reddish hair appears and introduces himself as the person I'm looking for.
J. is 21 and has been guinea-pigging since 1994, when he answered a newspaper ad for a generic drug study that paid $500 for four weekends of testing. "I realize now that was a terrible study," he says. "I rank studies on the number of days per the cash you get."
Many novice test subjects fail to calculate how the flat fees offered by research companies translate into dollars an hour, J. says. A fee of $1,500 or $3,000 seems lucrative at first, until you factor in the number of required stays in the lab. (If you do the math assuming a seven-hour workday, J.'s first study paid a modest $8 an hour). Fees for studies at contract research organizations usually top those offered by universities. In one especially active year, J. earned $18,000 from guinea-pigging. "The only reason I got a real job is that I was bored during the week," he says.
J., who now works full time in another local coffee shop, has "volunteered" for trials of generic painkillers, heart medications and drugs designed to ease symptoms of Parkinson's disease. "At the start, you get a manila folder that describes all the potential effects," he says. "I won't do studies where the side effects are too crazy."
He's passed out once, during a study of a blood-thinning medication. "I was on a couch and I woke up and then woke up again," J. says. The only other memorable side effect was a temporary loss of concentration. "That was kind of fun. You'd start to read a book and ... " His voice trails off as his eyes settle on a spot near the ceiling.
Aside from the occasional lab technician who's not particularly good with needles, J. says most studies involve nothing scarier than being confined to a dormlike series of rooms with a bunch of strangers for hours or days at a time. The more prosperous research labs feature televisions, comfortable furniture, video games and quiet rooms. Meals are catered, since some foods can interfere with the medications being studied, and vigorous exercise is discouraged for the same reason.
Still, because of the potential risks, guinea- pigging does require steelier-than-average nerves. That's evident from the stripped-down shorthand J. uses to talk about his work. Studies that require overnight or weekend stays are "lockdowns." The required 30-day waiting periods between experiments are "washouts."
The bravado is more than verbal. Some of the bolder guinea pigs have gotten around the waiting periods by working out or using herbal remedies to disguise the presence of medications in their systems, J. says. Others have learned how to take advantage of the one-time bonus payments some companies offer for referrals, by claiming to know strangers who show up for the same studies. Still others have lied about their age or have smuggled contraband into the "dorms." There are tales of people doing LSD in the cushy confines of corporate research units. "One dude smuggled in a gun, piece by piece," J. tells me, with an admiring shake of his head.
But overall, guinea-pigging just isn't that glamorous, he says. And despite parents and friends who clip headlines for him about clinical trials gone wrong, J. remains confident that the vast majority of studies are safe. "You just have to trust the company," he says. "This is really pretty mainstream."
Shared guinea-pig lore is full of wild and crazy tales. One local filmmaker calls to tell me he's had a guinea-pig experience "right out of Frankenstein." But he says he can't share the experience publicly because he's copyrighting it for future use in Hollywood.
I get luckier with an e-mail from Guinea Pig B., who's says he's eager to divulge his "iron man stories" from the early 1980s, when researchers at UNC-Chapel Hill were studying the effects of marijuana and other drugs on human subjects.
As a chemistry major at UNC, B. was expected to sign up for research studies for academic credit. He soon discovered that some of those gigs paid money as well. "As a healthy, active male who showed up on time, I was called back frequently," he says. "At $5 to $10 a donation, I would bleed on command. It was better than many part-time jobs."
Then, one summer, he landed his dream assignment: taking "recreational" drugs for money. Researchers at UNC were paying $300 to volunteer users of marijuana, cocaine and amphetamines to see how they metabolized the drugs. Although the tests involved multiple lab visits, blood draws and being hooked up to an IV, they had their up side, too. "Hey! Free drugs," B. says. "And the place where they did the studies was set up more like a hospital room than a lab. Just a relaxing place where you could stay until you came back to your senses."
Aside from feeling "a little lethargic," B. says he suffered few unpleasant after-effects. One narcotic he was given intravenously made him throw up, but that turned out to be because the dosage was too high. There were other small disappointments. "The marijuana they had wasn't very good," B. says. "It came from a government lab somewhere in Alabama."
He didn't shrink from more intimate assignments. During his years as a graduate student, B. and his wife signed up for a study of a now-outdated plastic condom. It was like wearing a baggy during sex, he says. But that didn't interfere with their scientific zeal. B. and his wife ended up "setting a record" by completing the required seven sexual encounters in a week, instead of the typical month. "We laughed our heads off," he recalls. "It was the most fun we've had in the bedroom."
Now 38 and working at a biomedical company in Maryland, B. sees guinea-pigging as part of his duty as a scientist. He's aware of the risks and can cite the latest accounts of deaths during clinical trials. (In one recent case reported by The Associated Press, 53 patients died during a study of an experimental heart drug for Indianapolis-based Eli Lilly & Co. The tests, which were being conducted at research labs around the world, were discontinued by the company.) But they haven't discouraged him from being a research subject.
B. even wonders whether--despite slip-ups such as those found at Duke--some of the rules for patient safety have become too rigid. "You have to sign three pieces of paper now just to donate blood," he quips. "In some ways I think that's a good idea because there are, in fact, risks. You could get a bruise."
I'm beginning to wonder whether present-day guinea-pigging is the purview of extroverts, rugged young men and self-described science geeks. Then I get a call from Guinea Pig S.
We meet at a diner in Johnston County. She drives up in a light blue truck that has seen better days. She wears an ace bandage on one freckled arm, a T-shirt and blue jeans. Her strawberry blonde hair is swept up in a loose knot on top of her head. With S. is an elderly woman who gets down gingerly from the truck and sinks into a wheelchair, which S. then rolls briskly across the pavement to the restaurant door.
Talking with S. dispels my residual guinea-pig stereotypes. She's a 48-year-old mother of three, trained years ago as an emergency medical technician. In the Triangle, she's worked in factories, as a substitute teacher, for a temp agency, and as a home health-care aide (her elderly friend is a current client). Her husband works in a local lumberyard.
At the start of the year, S. sits down with a calendar and plots the number of clinical studies she can comfortably squeeze into her schedule. She usually qualifies for four or five, which, counting the required "washouts," fill up most of the year. She's enrolled in a long-term AIDS study at a university clinic (she's part of a healthy control group) and several drug trials at PPD. Most recently, she answered an ad for a marketing study of support hose for people with poor circulation. "I had to wear those two or three times a week. And two of them, I definitely would not buy," she says. "In the end, I got to keep the stockings and $20. Pretty cool."
S. got into the field four years ago at the urging of a friend whose employment mantra was "try studies, studies are the way." Her first guinea-pig job was a one-day test for a medicine designed to soothe heartburn. Lunch was included.
Since then, S. has pedaled bikes, had gallons of blood drawn, even tolerated MRIs for the greater good. One study involved a muscle biopsy where they cut "about a quarter of an inch" out of her right thigh. "They told me I could go back to work, but I didn't tell them that I had a stand-up job in a factory at the time," S. says. "By the next morning, I had big blue blotches all over my thigh."
She likes meeting new people and "rambling around and learning what's new in the medical field." Her EMT training gives her an edge when it comes to understanding lab procedures and interpreting consent forms. As for the people she encounters, "They are totally, totally different," S. says. "At a weekend lockdown, I met a student, a doctor, a model, a girl who'd been married to a millionaire, a lady with a screen-print business and a kid from Fayetteville whose dad dropped him off at the clinic. It's a total cross section."
While she may joke about being a guinea pig with fellow test subjects, S. rejects any suggestion that she's being exploited. "When you sign that consent form you're saying I am responsible even if my insides fall out," she says. "And you know if you want to do the next study you have to stay good and healthy. It keeps you on your toes."
How long will she keep this up?
"As long as I can fit a profile," S. says.
When I reach Robert Helms at his home in Philadelphia, he has a four-hour-old needle mark in his arm from one of his latest jobs. A former union organizer who now works almost full time as a human test subject, Helms is a leading champion of guinea-pig rights--a firm believer in the collective power of this oppressed class.
Many of his views on the profession can be found in Guinea Pig Zero, an occasional "jobzine" Helms has been publishing since 1996. In the pages of GPZ, parallels abound between guinea-pigging and prostitution, another fringe occupation where workers put their bodies on the line. People who volunteer for psychological experiments are called "brain sluts" and those who sign up for physical studies are "bio sluts." A feature on a Texas research lab mentions nearby strip clubs that also employ healthy young people who can produce the required ID. "Selling yourself is so primal," writes a contributor to Issue No. 6.
Some of that is just guinea-pig humor. But Helms does see distinct similarities between work in the sex industry and in the research labs: "It's physically invasive, the payment is as high as it is because it's got a certain social stigma attached to it, and it puts the worker into a confused or blurry role in relation to the purpose of the work and those buying the services."
For one thing, neither sex-trade workers nor guinea pigs can afford to be completely honest with their employers. "If I'm asked, 'Have you experienced any discomforts, have you avoided all caffeine beverages during this study?,' I will give the expected, correct answers or I will become less employable as a guinea pig," Helms says. "Compare this with, 'You feeling sweet tonight, honey? Does that feel good?' And you'll see the patterns emerge."
Safety is another blurry element, since the risks of guinea-pigging are hard to quantify. Like the airline industry, universities and contract research organizations can accurately claim that the vast majority of studies are performed safely. But such claims are cold comfort when this turns out to be the rare flight that goes down.
Helms is unwilling to cede the safety issue to federal regulators or laboratory spokespersons. "Rest assured, every time there's a mishap, there's a cover-up, or at least the vigorous attempt at one," he says.
GPZ's mission is to expose dangerous episodes and "near misses" by any means necessary. An early issue of the zine was dedicated to a 19-year-old woman from Rochester, N.Y., who received a fatal dose of an anesthetic during a study on smoking and air pollution. Her pay was $150. Recent issues feature articles on how psychiatric patients were misled about the side effects of drugs they were being asked to test, and on the gruesome procedures performed on women donating eggs to fertility clinics.
The zine also issues regular "report cards" for research units across the country that rate their policies on pay, recruitment, security and patient consent. One such review landed Helms in court when a facility that had earned an F, Allegheny-Medical College of Pennsylvania in Philadelphia, sued for libel. The case was settled by Allegheny and Harper's Magazine, which had published excerpts of the critical report. (GPZ has yet to publish a report card for a Triangle-based research unit.)
With the increasing commercialization of scientific research and a rapid rise in the number of new clinical studies being proposed, regulators have been giving more weight to questions raised by Helms and other advocates about the treatment of human test subjects. In the past two years, Congress, a presidential Bioethics Advisory Commission and the federal Office for Protection from Research Risk (OPRR) have all been re-examining what goes on at public and private research units. The head of the OPRR, Gary Ellis, was an early subscriber to Guinea Pig Zero. "It's an interesting perspective," he told a writer for The Associated Press.
Helms welcomes the attention, but so far, he's unimpressed with the results. "There have been a few shutdowns of research operations," he notes. "But that's just political theater."
Safety issues aside, the use of human guinea pigs raises ethical questions that aren't easily addressed by government regulations. "The bottom line is, existing laws do not protect people from being lied to," Helms says. "There are terrible penalties for defrauding a research sponsor. But the doctor who lies to a patient or a patient's family--who says, 'I'm going to give you a new treatment' and the new treatment is really an experiment--nobody is going to be locked up or lose their medical license for that" because chances are, no one will ever find out.
So what is to be done? Helms says that better pay and safer working conditions for guinea pigs would help ensure that scientific advances aren't made at the expense of people who lack money and clout. Because while research units have worked to clean up their image, they still prey on the vulnerable. "For some of the more risky studies, the only people who could possibly be interested in doing that have got to be derelicts off the street," he says. "It's the same as the drunk selling plasma for hooch."
A little respect would also be nice, advocates say. Guinea-pigging may look like a fringe occupation, but would we have AIDS cocktails or asthma drugs without it? As Helms writes in GPZ's "statement of purpose," if we allow research subjects to be mistreated in the name of progress, "we may fall victim to the evil uses devised for us by scientists who forget that we and they are of the same species."
To subscribe to GPZ: write to P.O. Box 42531 Philadelphia, PA 19101 or e-mail: firstname.lastname@example.org. Subscriptions are $5 per issue or $15 for four.