Brandon L., 30, spent a good part of the summer of 2007 in a sterile research facility. He shared a sparse dormitory room with a semiretired prison guard, a massage therapist who liked to tell S&M stories, and a man with a taste for sappy, made-for-TV movies. Despite the little the four men had in common, they got along well, except for the occasional squabble over the TV remote. Brandon, the guard, and bondage boy would want to watch "Cops," but the sappy guy preferred Lifetime.
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Every day started and ended the same way: lights on at 5 a.m. and off at midnight. In the intervening hours, the medical staff delivered three meals and took away blood, urine, and fecal samples.
It wasn't some ultracontagious disease that kept these men in quarantine; their confinement was self-imposed. In fact, Brandon and his roommates were professional guinea pigs who volunteered to take part in a medical trial at Ohio State University to determine how an experimental antinausea pill would interact with an existing antifungal medication. In exchange for allowing themselves to be used as human pincushions, they each received $3,000.
In the past 18 months, Brandon has traveled throughout Michigan, Indiana, and Texas to submit himself to medical experimentation. He has earned roughly $25,000. Not bad for a man whose previous career trajectory consisted of being fired from one part-time, minimum-wage job after another.
"This is the longest I've ever done anything," says Brandon. "I don't plan on doing it forever, but it sure beats the heck out of working at a regular job."
Every year, millions of Americans loan their bodies to science. Some are desperate to find a cure for what ails them. Others who are healthy just participate in the occasional study for some extra cash. But many are like Brandon: They're healthy, and they dump low-paying jobs for a career as a professional lab rat. In exchange for undergoing trial treatments, they receive hundreds and sometimes thousands of dollars. The more time and inconvenience involved, the more money they stand to earn. One 4-month NASA study in Galveston, Texas, paid $17,200. So what if you couldn't get out of bed for 90 days?
But the problem arises from the other things a career guinea pig will do for money. In a Johns Hopkins survey of research volunteers published last spring in Clinical Pharmacology & Therapeutics, 10 percent of the sampled group admitted to participating in more than one study at a time — most likely without the knowledge of the researchers.
In any other line of work this would be called moonlighting, but in clinical trials it's Russian roulette. Consider this scenario: A man decides he can secretly juggle his role as a rat for a new headache medicine with his position as pincushion for an STD vaccine. On the surface, there's no harm. But inside the man's body, the two drugs interact in completely unpredictable ways. Maybe nothing will happen. Or maybe he'll experience life-threatening side effects, some of which will hit him immediately and others of which may take years to show up. Ultimately, the cost to his health will be as random as the spin of a gun cylinder.
So why should you care that some folks are willing to turn their bodies into test tubes to make a buck? Because these guinea pigs may be gambling with your life, too.
The results of clinical trials are used to help researchers (and later the FDA) determine if a drug is safe and effective for the general population. If those results are skewed by a significant number of volunteers enrolling in multiple studies, it's possible that either a worthy drug will be kept out of people's hands, or a dangerous and/or ineffective med will be allowed to enter the market. In the latter case, you the consumer become the guinea pig.
Since 2000, some highly touted drugs, including Rezulin, Baycol, Bextra, and Vioxx, have been recalled by the FDA or pulled from the market by their manufacturers following reports of serious side effects or patient deaths. It's impossible to know if any of those recalls were the result of tainted trials, but the possibility exists.
"If these professional patients don't disclose that they're taking a drug [in another study] that is contraindicated with the new experimental medicine, consumers can end up having drug interactions, which kill 100,000 people every year," says Richard Gabriel, CEO of DNAPrint Genomics, a drug-development company focused on gene-based pharmaceuticals.
Nancy Kass, Sc.D., the lead author of the Johns Hopkins study, agrees. "This is the kind of thing researchers worry about a lot, because it affects the research and can endanger volunteers," she says. "In one institution, it's easy to keep track of who's in what study. But if you go to Duke one week and the University of North Carolina the next week, who would know?"
Not a soul, in part because the double-dippers have federal regulations on their side. "The government requires that personal information that could identify research participants be kept confidential," says Kass. As a result, there's little chance of catching volunteers who skirt the rules, and that includes people who keep quiet about past or current physical conditions that have the potential to skew study results.
Abuse of system often overlooked
Remember Brandon? When he applies for a clinical trial, he never tells researchers about his bout of chlamydia or a concussion he had in his teens. "Everybody lies about their medical history, drug-abuse history, and sexual history," he says emphatically. "You have to. The ones who say they don't are full of shit."
While confidentiality rules give guinea pigs the cover they need to straddle multiple studies, those guinea pigs also benefit from a testing system that increasingly overlooks — and sometimes even encourages — abuse.
Two decades ago, 80 percent of drug-company trials were conducted at medical centers with academic ties. By the turn of the century, that number had fallen to less than 40 percent, notes Harvard medical school's Marcia Angell, M.D., in her book "The Truth About the Drug Companies: How They Deceive Us and What to Do About It." In an effort to streamline operations and increase profit, the vast majority of pharmaceutical firms have outsourced their trials to third-party, for-profit testing centers known as contract research organizations (CROs).
It's this shift from science-oriented settings to those propelled by profits and losses that has watchdogs worried. Consider Covance, a CRO headquartered in Princeton, New Jersey, with annual revenues exceeding $1.4 billion and operations in more than 20 countries. Covance's Web site offers a glimpse into the business philosophy that has helped the company become one of the largest and most comprehensive clinical test centers in the world.
Covance knows the significant pressures pharmaceutical and biotechnology companies of all sizes face in developing and launching drugs backed by strong data ... Covance is dedicated to helping bring your miracles to market sooner.
And the most time-consuming part of any study? Finding volunteers. "These CROs are paid to recruit physicians, whose pay, in turn, depends on the number of patients they recruit," says Peter Lurie, M.D., the deputy director of Public Citizen's Health Research Group. He claims this focus leads some of their screeners to take on volunteers they may suspect are participating in simultaneous studies, as well as those with complicating health conditions.
"The abuses are in overlooking factors that would exclude certain people from certain trials, such as being too fat, too thin, or having blood pressure that is too high or too low," says Dr. Lurie.
Kenneth Goodman, Ph.D., co-director of the University of Miami's ethics programs, witnessed a host of such abuses when he visited the Miami testing facility run by SFBC International, at one time the largest for-profit clinical-trials testing facility in North America. "It was a bazaar. I saw people asking 'What do you have for $2,500?' while others were allowed to choose from a menu of ongoing experiments," he recalls. "If the rules were followed scrupulously in letter and in spirit, it would cost more money. They'd have to spend more time talking to people, and they'd have to tell some of them, 'Sorry, you can't be on this study.' "
In 2005, Bloomberg Markets ran a report that featured SFBC's Miami facility. It described overcrowded conditions, confusing and potentially misleading consent forms, and volunteers so desperate for money that they didn't think twice about enrolling in more than one study at a time. It also prompted a 2006 class-action lawsuit (and a reported $28.5 million settlement agreement late last year) on behalf of angry investors who not only accused the company of securities fraud but also charged that trial payments were delayed to keep volunteers from reporting adverse events. Latin American volunteers who were immigrants reportedly were threatened with deportation if they didn't retract their statements to the press.
Struggling immigrants, the chronically unemployed, cash-strapped college students — anyone who's financially needy is fodder for a CRO-run study and more likely to be a professional guinea pig. CROs located in urban centers or near college campuses have easy access to pools of potential, and vulnerable, volunteers.
"The enterprise of nonacademic drug research requires volunteers who are willing to run the risks of the experiments," says Goodman. "They are often incentivized with money, which can lead to unintended consequences. Does being poor cause someone to set aside the risks? Sure it does. Does this kind of drug research rest on the backs of poor people? In many respects, yes."
Professional lab rats
Paul Clough, 29, began making a living as a professional lab rat more than 3 years ago. He had washed out as a bus driver and was working as a day laborer in Kansas City when he learned he could make $600 for a 3-night study. Within a year, he'd moved to Austin — lab rats consider it the mecca for clinical trials in the United States — and has been supporting himself with research studies ever since. He has earned about $75,000 participating in two dozen studies but says he lives from check to check.
Clough knows that most professional guinea pigs cheat but he insists he doesn't. He is the man behind jalr.org (just another lab rat), one of several Web sites people visit to find information about ongoing and upcoming clinical trials.
"After my first study, I researched all the clinics and created the site to start preaching the cardinal rules — like telling the truth and waiting the right amount of time between studies. As long as your lab tests are in range, a clinic has no way to verify you're doubling up unless you flat out tell them."
Registrants at jalr.org share information about the facilities — everything from rooming arrangements to catering and food services to entertainment amenities (TV, rec rooms, Wi-Fi). Other sites, such as gpgp.net (guinea pigs get paid), clinicaltrials.gov, and biotrax.com, list drug trials, but pro guinea pigs laud jalr.org as the best.
Nick Pesa, a fourth-year medical student at Cleveland's Case Western Reserve University, takes a more low-tech approach to finding trials. He and fellow classmates Nikolai Sopko and Jason Snyder scour the newspapers and bulletin boards at Case Western, University Hospitals, and the Cleveland Clinic. In 5 years, they've earned roughly $20,000 each, along with the campus nickname "guinea pig gang."
"From a medical student's perspective, it's interesting," says Pesa, "because you refer patients to these procedures but you never know what the process is like until you've been through it."
Doubling up on studies or skirting the guidelines is tough for them, because the institutions where they're tested keep good records and share detailed information about study participants. But Sopko admits that he recently lied about being a runner in order to be in a microgravity study for NASA. The three men have each experienced the occasional bad reaction — like when Sopko couldn't sleep, eat, or focus for a week after testing an anti-inflammatory steroid.
"You had to take a pill and didn't know if it was the steroid or a placebo," he says. "Right after I stopped taking it, I had a chemistry test and bombed it. I couldn't concentrate. I was on the real thing."
Given that the FDA relies on the results of clinical trials to decide if a drug is safe and effective for public consumption, one would expect the agency to be invested in ensuring the quality of those trials. And in fact the FDA does oversee all clinical trials. It just doesn't do a very good job.
Poor government oversight
Last September, a report from the inspector general of the U.S. Department of Health and Human Services concluded that FDA officials had no system for identifying all ongoing clinical trials. The report also noted that the FDA had checked fewer than 1 percent of the nation's estimated 350,000 testing sites, which isn't all that surprising when you consider that there are only 223 inspectors.
It gets worse. Most of the inspections focused on verifying data after a clinical trial had been completed, and just one in four looked at trials in progress. What's more, 68 percent of the serious problems inspectors identified as needing official corrective action were later downgraded, mostly to voluntary compliance, by other FDA officials. In those cases, the FDA isn't required to follow up to see if the problems were addressed.
"The agency agrees with the report and is already acting on all of its recommendations," the FDA said in a prepared statement. "Volunteers play a critical role in making treatments available that help millions of patients, and the FDA is committed to ensuring strong oversight to protect participants."
The government is not much better at monitoring its own studies. The Office for Human Research Protections (OHRP), the agency responsible for overseeing federally funded clinical trials, is also understaffed and swamped. "Before an organization can receive funding from Health and Human Services, they have to register with our office," says one OHRP spokeswoman, Pat El-Hinnawy. "There are, at last count, some 9,000 of those type of agreements; our office comprises about 38 people."
Still, in theory, any problems missed by the OHRP or the FDA would be caught by an institutional review board, or IRB. Before any clinical trial can proceed, an IRB evaluates the study plan to make sure the testing is ethical and that participants' rights are protected. Formation of these oversight committees was mandated in 1974 after details came to light about the Tuskegee Institute study that left black men untreated for syphilis for four decades. Today, however, many IRBs are run for profit, creating an incentive to rule favorably on studies so that CROs won't take their business elsewhere.
"Rather than have the government review the study, the institutions conducting the research select people to review their research," says Dr. Lurie. "There's an obvious conflict of interest."
Even the drug-testing industry's strongest critics concede that the work is necessary and beneficial to society, and they don't want to see it stopped. What they want is better safeguards, more honest reporting, and more stringent oversight. In the end, this could mean less money for the drug companies and the professional guinea pigs.
One possible solution: DNAPrint has developed PharmaID, a bar-coding system designed specifically to prevent volunteers from scamming the system. Each participant is assigned a bar code, based on his or her DNA, that is entered into a central system. If that bar code shows up in another trial within a time interval deemed inappropriate, that person could be excluded from the study without having his or her identity or medical information disclosed. This safeguard would add about $300 per patient to the cost of the study, which might explain why it has generated lukewarm interest so far.
In the meantime, the broken system will continue to draw the professional guinea pigs — guys like Robbin Stewart. After he was laid off from his warehouse job in Indianapolis, he discovered that he could make a decent living by participating in clinical trials. He met his modest goal of $10,000 annually within the first few months by traveling to different clinics in the Midwest. "I pay very little attention to what the drug is about," says Stewart. "I worry more about having a highway accident than something happening in a study."
As for Brandon L., he continues to scour the Internet for upcoming trials, although reaching them is a bit of a problem since his license was suspended and his '99 Chevy Prizm padlocked after he racked up his fourth DUI. He plans to move to Austin, which has enough testing facilities to keep him busy.
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