Healthy Males Needed For Research Study," beckons the tiny announcement in the Miami Herald classifieds. "Ages 18-45; 5 days confinement; 18 clinic visits." Then, in slightly larger type: "We Pay You $1100."
A call to the listed phone number yields a curt female receptionist and an address on NW 22nd Avenue in Miami's Allapattah neighborhood, where interested parties are instructed to stop by for a checkup. There, in the bleak waiting room of an ordinary-looking medical clinic, candidates are handed an eleven-page form describing the research study, which involves an "investigational new drug" for the treatment of high blood pressure.
The confinement consists of a 36-hour inpatient stayover at the clinic, followed by nine brief daily checkups, whereupon the process is repeated. The form warns that clinicians will extract blood from each participant 50 times and that in a past experiment involving the same drug, some people experienced side effects including headaches, diarrhea, and abnormalities in liver enzymes. A similar class of drugs has caused, among other side effects, nausea, low white blood cell counts, excessively low blood pressure, and kidney damage.
Tucked away on the form's third page is another warning: "The investigator shall inform you of all known risks, however, you must consent to take part in this study with full knowledge that there may be adverse physical, mental or genetic results which the investigator has no way of anticipating."
For some, such a disclaimer might provoke deep reflection about the nature of human mortality. For Jim Farrell, self-described "professional lab rat," it's barely a distraction. "I guess you never know what might happen -- side effects and all," shrugs Farrell, who by his own count has participated in about eight clinical drug trials during the past three years. "I figure considering the shit I put in my system from the 1960s to the present, the shit they're putting in me won't make a difference."
At a little before noon on this midwinter morning, the 54-year-old Farrell is hunched over the counter at Wolfie's on South Beach, clutching a Heineken A his lunch. Two weeks earlier, he completed a seven-week inpatient-outpatient study at a northeast Dade facility testing the interaction of four prostate and blood-pressure drugs. He practically bounded out of the clinic that morning carrying a small suitcase, his manual typewriter, and his salary of $2400, full of plans to rent a cheap room for a few days, then head north to work at a friend's business in Palm Beach County. "I think I'm going to have a bloody mary, call up the ex, and see if I can get my life back together again," he declared at the time.
Indeed, Farrell needed such a plan. A native of Massachusetts and a former bank robber who has spent a considerable block of time behind bars, Farrell has had a disastrous two years. The hurricane blew his wife and him out of their home and into a FEMA trailer park. On three different occasions, he was admitted to the psychiatric ward of the Veterans Administration Medical Center, and once entered a substance abuse center to treat alcoholism. He divorced and spent long periods of time living on the street, sleeping in parks, at the Salvation Army, or, as he says, "anyplace I could find that was halfway safe and dry."
It was during this period of desperation that Farrell became involved in clinical drug studies. "I wouldn't say I got hooked on them, but I will say they sure come in useful," he observes.
Each year thousands of people in Miami participate in drug trials. Many suffer from the illnesses the drugs are supposed to combat. But in the competitive world of drug research and development, there's also a need for a pool of healthy volunteers to serve as blank slates on which the markings of a new drug can be observed. This need has given rise to a population of professional subjects who regularly rent out their bodies, not for the betterment of mankind, but for the money.
The lab rats are a mercurial band of unskilled laborers far removed from the frontiers of modern medicine they're helping to chart. Many live on the margins of society, indigent and in need of cash, homeless or nearly homeless. They're alcoholics who have drained their last penny or gamblers who've bet theirs away, low-rent travelers looking to move on or layabouts who can't motivate themselves. A few are elderly citizens who could use the financial boost. Most don't look to clinical studies as their sole source of income; many say they're only a study or two away from their last A if only they can build up enough savings this time to buy a car and find more gainful employment somewhere else. But a substantial number return to sign another consent form, ingest another set of mysterious pills, and submit to more prodding and probing.
Despite his intentions to put his life on an even keel, Farrell didn't leave Dade when he got out of the seven-week study. A day after taking a room in a cheap Miami Beach hotel, he hailed a taxi and instructed the cabbie to turn off the meter. The two of them, in Farrell's words, "hit every titty bar from here to North Miami." By the next morning he was broke. "Bad judgment," he concludes, draining his beer.
He rises from the Wolfie's counter and weaves to the sidewalk. Out of money, he has to move out of his hotel room today. Next stop: the state social services office on Sixth Street for his allotment of food stamps. Then the street A to find a place to sleep. "The party's over," he mumbles, half to himself. "Here I go again."
According to an acquaintance with whom he irregularly keeps in touch, Farrell isn't down and out for long. Within a month, he will have found his way back to the relative shelter of another clinical drug trial.
The big business of drug development is marked by failure. Pharmaceutical Research and Manufacturers of America, a Washington, D.C.-based trade organization, estimates that of every five thousand chemicals studied, five will be tested on humans, and only one will reach pharmacy shelves. On average, says spokesman Steve Berchem, it takes twelve years for a new drug to make it from lab to market, at a cost of about $400 million. "Which is what it costs to build two-and-a-half football stadiums," Berchem adds.
The U.S. Food and Drug Administration (FDA) is responsible for approving new drugs and medical devices. But before it gives the okay, the agency requires that pharmaceutical manufacturers submit evidence that the drug under review is safe and effective. The drug makers conduct the tests in test tubes, animals, and people in order to supply this proof. For the human component, pharmaceutical companies arrange with physicians and hospitals to conduct studies, which generally are done in three phases. The first phase, usually involving fewer than 100 subjects, is intended to measure the safety of a drug and what happens to it in the human body. Phases two and three require anywhere from several hundred to thousands of test subjects and are designed to show whether a drug is effective in treating the disease or condition for which it is intended. For obvious reasons, the latter two phases almost always utilize test subjects who suffer from the ailment in question. For phase-one tests, though, clinicians need healthy bodies, and it is for these studies that professional lab rats usually volunteer.
In Miami drug experiments involving humans are performed in hospitals and medical schools, private laboratories, and medical clinics. At any given time, the University of Miami/Jackson Memorial Medical Center alone is the site of more than 2000 clinical drug trials, making it one of the busiest research facilities in the world, according to Robert Rubin, vice provost for research and deputy dean for research and graduate studies at UM's School of Medicine. The experiments are supported by grants from pharmaceutical companies, foundations, and the federal government.
A majority of the studies involve sick patients, Rubin says, adding that there's usually no need to pay subjects because the facility has a ready pool of patients who suffer from the illnesses the drugs are meant to combat. "We service all of South Florida -- we have more than a million patient days a year -- and we use that population who are motivated to help science and to help themselves," he explains.
Though UM/Jackson also conducts phase-one clinical drug trials in which participants are paid, professional lab rats in Miami say they prefer to hopscotch chiefly between three private drug-testing clinics A Clinical Pharmacology Associates in Allapattah; South Florida Bioavailability Clinic, Inc. on Biscayne Boulevard in northeast Dade; and Peninsular Testing Corporation in North Dade. These for-profit clinics frequently contract with pharmaceutical companies to test drugs and, according to veteran volunteers, typically pay more than the university A as much as $100 a day for experiments requiring inpatient participation. (Despite repeated requests, officials at the three clinics refused to be interviewed for this article.)
Besides the fact that UM's rates usually don't compete with what the clinics offer, the university doesn't do much outside advertising or recruiting. Lab rats are on intimate terms with the "announcements" portion of the Herald classifieds, known among veterans simply by its section number: 147. The clinics also go a more direct route, according to veteran volunteers and others. A clerk at the Tropics Hotel, a Miami Beach inn frequented by backpacking foreigners, says clinics have called trying to track down specific veteran participants to take part in certain trials.
Experiments vary in length and intensity, depending on the compound being tested. Some may require as few as two or three outpatient visits involving basic, noninvasive tests. Others may call for inpatient confinement of more than a month, and frequent drawing of blood.
Human subjects interviewed for this article say they've tested substances from toothpastes to synthetic opium. Though their recollections of the studies can be quite vague, one detail invariably remains fresh in their memories: the amount of payment.
"Zbig" recalls that he once was involved in a study at Clinical Pharmacology in which he lost six pounds in nine days. "I think it was some blood-pressure thing," he says. "It was a tough one." And worth the $900 he was paid. "Jay" volunteered for a three-day experiment at Peninsular that paid $560. One day the drug he was given rendered him utterly inert. "You couldn't move; you were almost comatose," he remembers. (Some people interviewed for this story agreed to have their full names used, while others gave only their first names or made up pseudonyms; wherever pseudonyms appear, they are enclosed in quotation marks. Also, because clinic operators declined to talk to New Times, no payments or other details could be verified.)
Among the most demanding of the 30-plus trials he has undergone, says veteran rat John Mains, was a monthlong confinement to test what he recalls was "a heart medicine." He endured 100 blood draws, sometimes at the rate of once per hour throughout the night. His participation earned him $3000. In terms of stamina, Mains says nothing in his drug-trial career compares with a 60-day inpatient test he underwent at a local clinic: "I can't remember the drug, per se, but I remember 60 days straight through."
Almost all the volunteers who spoke to New Times say they have never second-guessed their decision to participate and have no fear about the possible effects of the drugs they're testing. While some assert that they choose their experiments carefully, others trust the doctors who run the studies. "The drugs have been on the market for years; there's nothing new," imparts Joe, a sometime-cook at a homeless shelter downtown who has been participating in drug studies for three years. That faith is shared by Nick, a "laborer-masoner-roofer-whatever" interviewed by phone while undergoing his first study, involving "a drug for nerves or something," as he puts it. "There can't be anything life-threatening about this," he reports from Clinical Pharmacology. "The insurance would be too high if it was dangerous," he reasons.
"Jay" says he heard through the volunteer grapevine that a clinic in Connecticut was conducting an experiment wherein investigators would sever a volunteer's little toe, then attempt to surgically reattach it to the foot. "It paid $20,000," he notes brightly. "I tried to get into that one." (Other veteran volunteers say this experiment is purely apocryphal, a part of guinea pig lore.)
John Mains recounts a prank he orchestrated to test the daring of his colleagues: He and some fellow pranksters posted a notice on a clinic's bulletin board, soliciting volunteers for a fictional study. "We said that the chance of dying was only ten percent, only as a joke. We said it paid $5000 in two weeks," he recalls. "Half a dozen people signed on almost immediately."
Tales of experiments gone awry are rare but sobering. One volunteer, a manager at a South Beach grocery store, took part in a test a couple of years ago involving a drug for diabetes. "I knew it as 'Wag-99'; it has something to do with insulin users to bring up their heart rate," he remembers. Before he submitted to the experiment, which paid $1000 and involved a lot of lying in bed, he consulted with the investigating doctor, whom he knew socially. "I sat down with him. I wanted to know exactly how it was going to affect me," he says. At one point during the nine-day trial, he began to pass out. "The [clinicians] were all in a panic, they were there so quickly," he remembers. "It was scary." The investigator took him off the medication for a couple of days, then resumed lower dosages. "It was only nine days, but it was like a lifetime for me."
As a result of his experience, the unfortunate volunteer says, he will never participate in a medical experiment again. "When I see some of the people who have been doing it for a while, there seems to be a change in them from a couple of years ago," he notes. "They definitely look older, and I'm sure that mentally, along the way, something's happened."
"Jay" is a little hazy about the experiments he's volunteered for. His first was at a pharmaceutical research facility in his home state of New Jersey. "I don't exactly remember what it was about. You'd take a pill but there were a lot of blood draws," says the 27-year-old, sitting on a Miami Beach barstool and staring into the dim brown glass of a Bud longneck. Dressed in black jeans and a white T-shirt, he has the blond, bland good looks of roughly half the population of the Beach. What he does recollect about his first study is that after about three weeks, he left with $2700 in his pocket. "It was cool," he concludes.
So cool that he signed up for a few more, in New Jersey and here. He stopped two years ago when he found work at a resort, but since quitting that job he has been thinking about going back in for more quick cash. "That's one of the reasons I came to Miami," he explains. Until he gets admitted to an experiment, he has taken a part-time job as a busboy at a restaurant and is living at a Beach youth hostel. "This is for big money. That's the only reason why I do it," he says of the drug trials. "But this will be my last."
He reaches into his back pocket and pulls out a well-creased list of drug research centers around the U.S. Some guy was selling copies of the list at a study he did back in New Jersey, five dollars a pop. The margins are scrawled with Jay's own notations A payouts, names of clinic contacts, starting dates of experiments. Several variations of the list circulate throughout the Miami community of human guinea pigs. "I like to carry it around so I can fall back on it.
"I think people get trapped in it," he goes on. "I hope this is the last one. I want to get my act together. At least for me it's not an act of desperation; it's something to get me back on my feet. A three- to four-week stay in the hospital, you can get your thoughts together, plan your next move. When you get out, you got a clean head and money in your pocket." He sighs, fixes his eyes on his bottle. "I don't think less of myself because I do these tests. Maybe sometimes I do, I guess."
In a federally funded research project that began in the early 1930s in Macon County, Alabama, researchers allowed impoverished black men infected with syphilis to remain untreated in order to learn more about the disease. The so-called Tuskegee study continued through the early 1970s, well after penicillin became a known cure. (President Clinton's nominee for Surgeon General, Henry W. Foster, Jr., is under attack for his alleged involvement in the study.)
From the late 1950s until the early 1970s, doctors fed live hepatitis viruses to residents at the Willowbrook State School for the Retarded in New York. The lead researcher, Dr. Saul Krugman, became the chairman of the pediatrics department at New York University and went on to win the most-coveted awards for research in the U.S.
In the early 1960s, doctors at the Jewish Chronic Disease Hospital in Brooklyn injected elderly patients with live cancer cells in a study of immune response. The patients were not told what the injections were. The study was stopped soon after it began and none of the patients got cancer.
At about that same time, disgracing revelations about thalidomide testing were making headlines: Doctors in Europe had been giving the sedative to pregnant women in an effort to prevent miscarriages, and physicians stateside were evaluating the compound for approval here. When thalidomide was linked to a widespread incidence of fetal deformities, testing in the U.S. ceased. Amid Congressional hearings regarding stiffer drug approval regulations, however, Americans learned that some patients who had been given thalidomide in the U.S. hadn't known they'd been involved in an experiment. Equally alarming was the shoddy record-keeping of doctors and pharmaceutical companies alike -- it was impossible to get an accurate count of participants or to discern their identities.
All four scandals are now widely regarded as black marks in the annals of U.S. clinical drug trials, infamous instances in which doctors failed to inform and protect human subjects. Such flagrant disregard for people's rights and welfare is far less likely today, but the regulatory system of laws and oversight designed to protect volunteers is still far from perfect, and there's no guarantee of immunity from carelessness or unlawful procedures or from the unpredictable side effects of experimental drugs.
Just three years ago, an investigation into a promising drug to combat hepatitis B ended in tragedy: A toxic reaction to the substance killed five out of the fifteen volunteers participating in the National Institutes of Health study in Maryland; two others survived only after receiving liver transplants. A federal investigation into earlier trials of the same drug later revealed at least five other deaths and five hospitalizations that might have been caused by the medication.
Over the past few decades, federal regulators have codified the right of a subject to be told of the benefits, risks, and purpose of the research for which he or she is volunteering. The FDA also has written rules to guide the testing of drugs, medical devices, and other products. By law, whenever testing involves humans, a research protocol must first be developed to plot the course of the years-long trial. Researchers must submit the protocol to a panel of experts at the facility where they will conduct the trials. The panel, known as an institutional review board (IRB), has one concern: the welfare of test subjects. To this end, the IRB evaluates the ethics, efficacy, and safety of the study and ensures that the selection of subjects is fair, equitable, and representational of the drug's target population.
(Clinical trials in Miami are often age- and gender-specific. Until recently, all volunteers in phase-one clinical drug trials were men: old federal rules prohibited women of child-bearing age from participating. But new FDA guidelines passed in 1993 mandate that most investigational drugs be evaluated equally on both sexes, as well as on all target ages and races. According to one FDA official, while some drug companies have been extremely compliant, others have been slow to follow the new guidelines. Though phase-one clinical trials involving women frequently are undertaken in Miami, nearly all the volunteers New Times encountered were men. Bruce Netter, disaster-response coordinator for Catholic Community Services and a member of the board of the Dade County Homeless Trust, suggests one possible cause for the discrepancy: "From my experience, there is a much larger population of homeless men on the streets than women.")
The main focus of the IRB's review is the consent form, which is given to each prospective volunteer and is intended to describe the nature of the experiment and to spell out the potential benefits and risks of the test. The cornerstone of the consent form is the notion of "informed consent," a condition for participation in a clinical drug trial. Seemingly straightforward A does the subject agree to take part in the trial? A the issue is profoundly knotty, particularly when it involves pregnant women, children, the mentally handicapped, prisoners, or indigents.
"There are three components to informed consent," explains Kenneth Goodman, director of UM's Forum for Bioethics and Philosophy. "Number one: sufficient information. You've got to tell me what are the risks, what are the benefits, what are the alternatives. Number two: competence. If I'm drunk or insane or under the influence of drugs, my consent will be tainted. And number three: absence of coercion. For example, you can't say I won't get medical treatment if I'm not in your experiment."
Indigent people are particularly vulnerable because they may be susceptible to the coercive influence of money. "You don't want poor people putting themselves at risk when they're doing something only for the money," asserts Goodman, who sits on IRBs at UM, the Veterans Administration Medical Center, Baptist Hospital of Miami, and Vitas Healthcare, a local hospice. "How much money invalidates free choice? The answer is not clear."
The torturously vague FDA regulations certainly don't provide it. "An investigator shall seek [informed consent] only under circumstances that provide the prospective subject... sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence," the guidelines read in part.
"It's a very thorny issue, because investigators maintain they can't do their studies without so-called normals," says Joan Rachlin, executive director of Public Responsibility in Medicine and Research, a nonprofit advocacy and education initiative based in Boston. "And more often than not, the people who are available to go into a three-day sleep study are not gainfully employed. You're hitting people who need money, need health care. These are people who are extremely likely to rely on this money for their basic survival." Further complicating matters is the fact that the same sum might be viewed as a fortune by one person and peanuts by another.
Most industry experts agree that the ideal alternative -- altruism-motivated volunteers -- is unlikely to arise in a market-driven economy. "It's a lovely concept," Rachlin agrees. "But people don't do anything without reimbursement. Clearly, if the federal government saw in its wisdom to outlaw remuneration for participation, investigators would have to rely on employees or relatives of patients who would have a vested interest in the tests." Rachlin says some hard-liners argue that in place of healthy humans, researchers should implement more in vitro testing, studies on sick people, and computer simulations.
At the University of Houston, administrators have instituted a policy to not pay human subjects for taking part in painful procedures such as bronchoscopies (in which tissue is removed from the interior of the lung) or bone marrow biopsies. According to Paula Knudson, executive coordinator for the IRB at the University of Texas Health Science Center at Houston, the policy ensures that no one subjects himself to the most invasive procedures for monetary gain alone. "An eligible subject would have to be someone who has a personal interest in the research, maybe a family member of the patient who is infected by the disease the investigator is looking at," says Knudson, who notes that the policy hasn't inhibited the course of research at the institution.
While the burden of sorting out the definition of informed consent is largely left to the IRBs, they aren't acting entirely on their own. Federal law requires the FDA to review each of the nation's approximately 2000 IRBs once every five years. Paul Goebel, chief of the Institutional Review Branch at the FDA's Center for Drug Evaluation and Research in Rockville, Maryland, says Dade's $100-per-day average for inpatient studies seems "about right" when compared with other major metropolitan areas. While he acknowledges that it's "a fair amount of money," he says that considering the inconvenience and pain typically involved, "we have not seen something that's obviously overpayment to the extent we would second-guess the IRB."
Of course, informed consent also depends on the ability A not to mention the willingness A of potential volunteers to read and understand the consent form. Industry experts conjecture that the rate of partial or full illiteracy among the human guinea pig population is high, but according to UM's Kenneth Goodman, "Most of the protocols are written so badly and so inscrutably you have to be a physiologist to understand them. A couple of years ago, a study found that the average consent form was written at the level of a very sophisticated literary magazine. And many test subjects don't know how to read a daily newspaper!"
Even if the volunteers are able to read the consent forms they eventually sign, they often don't bother. Several human lab rats interviewed for this story admitted as much. "I try to read it. I try to be a little conscious of it, but I guess not," concedes "Jay." He adds, "A lot of the mentality [among volunteers] is, 'It can't kill you.' I think these tests are a minor risk."
"When I first heard about it, I was scared," 46-year-old "Zbig" admits. He's sitting outside a Miami Beach cafe sipping cheap wine out of a plastic cup, his tan face and blond curls giving him a youthful appearance that belies his age. "Then I saw people doing it on a regular basis, and they looked pretty healthy. So I decided to do it."
A native of Canada and a former circus clown, "Zbig" has been wintering in Miami Beach since the mid-Eighties, doing odd jobs and living in low-rent hotels. He has bunked at a Collins Avenue youth hostel the past few years and has tried to get by on medical experiments only. But he has achieved only limited success and has been forced to pick up supplemental work where he can: "Anything that makes money. I'm kind of on a tight budget," he says.
He's selective about the experiments he does: no injections, only pills. Usually drugs to treat high blood pressure and prostate complications. His last experiment was in December. "It was some pill, one pill a day doing two things at once A for prostate cancer and also for...what was it doing? Some heart regulation at the same time." After less than a month, he walked out with a $2305 check. "It's $100 a day, doing nothing," he says with an impish smile.
He plans to do a couple of more studies, then buy a car. There's also a chance he'll head to New York this spring and help a friend repossess cars. "Actually, I'm not very good as a worker," he admits.
Amused by an afterthought, he blurts, "The few, the brave, the guinea pigs!"
As ethicists tangle with the meaning of the law on a high philosophical plane, the existence of financially motivated volunteers raises other questions that cast doubt on the accuracy of the tests and the safety of the subjects. For one, volunteers say they are frequently motivated to circumvent the commonly accepted rule among clinics that prohibits subjects from entering a new study within 30 days of participating in another one. In order to evade the 30-day moratorium or to gain admission to tests for which they are legally too old or too young, they carry fake IDs. One foreign volunteer says that during a pre-screening at a local clinic, he claimed to have lost his immigration papers and was permitted to sign an affidavit on which he simply lied about his identity.
To combat such deceit, several clinics in Austin, Texas, recently discussed the possibility of a group registry of volunteers, according to the FDA's Paul Goebel. The idea never got off the ground, Goebel says, presumably because the initiative would have required a degree of cooperation the competing clinics weren't prepared to give.
Many studies requiring supposedly healthy subjects prohibit people who smoke cigarettes. But "Zbig" estimates that 75 percent of the participants he has encountered are smokers. Once admitted, they continue to smoke behind the investigators' backs. Some volunteers even tell of colleagues sneaking alcohol into the clinics, and of sneaking themselves out during downtime. (Both, say the volunteers, are expressly forbidden at clinics.) Local homeless advocate Bruce Netter says that from what he knows, the population of professional lab rats is indeed wily. "Most of them know how long it takes to clean up for a screening test," he notes. "And many are abusing drugs and alcohol in that window of opportunity between testing."
Deception typically begins at the outset of an experiment, when clinicians evaluate candidates' medical histories. Professional guinea pigs say they rarely, if ever, admit to an illness or a pre-existing condition that may disqualify them from entering a study: Competition for acceptance into lucrative studies can be fierce, and diehard lab rats aren't likely to let an infection, a known adverse reaction to a certain drug, or an allergy get in the way. "You lie," reveals "Zbig" matter-of-factly. "You have to lie a lot. You always say 'no.'"
The slippery nature of this transient subculture may also inhibit investigators who attempt follow-up testing after a trial has been completed. Such monitoring is difficult when you're dealing with subjects who don't have fixed addresses. "It's one thing for people who have health-care insurance to be in contact with doctors once the trial is over," points out David Orentlicher, director of the ethics-standards department at the American Medical Association. "But if you have a population that's likely to fall out of the health-care system, it's a good argument for saying drug companies have to make sure they keep an eye out and follow up with these patients."
Bruce Netter suggests follow-up attention that goes beyond health care and incorporates social services to help indigent volunteers find apartments and jobs. "Unfortunately, because of the nature of the population that finds the money enticing, and without supportive services for people coming out of the study, it's money they blow through really fast," he says. "It certainly doesn't do anything to increase their self-esteem or to integrate them back into the community."
Finally, some medical experts question whether relying on the same general pool of people to participate in tests makes for good science. "It might lead to bias in the results," conjectures UM's Robert Rubin. "You might be skewing the data scientifically." Orentlicher goes a step further, noting that because high quality medical care isn't always accessible to the nation's poor, they can't be counted upon to be in the best of health. "People who do it for pay might not be that representative of the [general population]," he remarks.
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."
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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