By Sarah Fenske
By Danny Wicentowski
By Lindsay Toler
By Danny Wicentowski
By Danny Wicentowski
By Jessica Lussenhop
By Lindsay Toler
By Lindsay Toler
Alecia Hoyt does it for the cash. The 25-year-old social worker says she was paid $450 to $850 apiece for four studies, each of which required two overnight stays. She uses the money to pay off her student loans, to make payments on her computer and for recreation. "My last one paid for a trip to Hawaii, where my boyfriend lives," says the St. Charles native and resident.
Lacking the luxury of boyfriends, 25-year-old Danette Wilson and her 23-year-old roommate Amber Powers of University City participated in a study in order to meet guys.
"During the screening we're seeing all these very attractive men walk out, all these college guys," Wilson says, recalling her first visit to the clinic, when staffers drew a blood sample and measured her height and weight. But it wasn't to be.
"We showed up to our test and we were like: Where did all the attractive guys go? Where was everybody's teeth?" says Wilson, who blames the dearth of hunks on the fact that the study permitted smokers among its participants. Hoyt even found herself having to fend off the advances of one unacceptable would-be Romeo. "He wanted to cuddle on the couch," she notes ruefully.
One chap -- let's call him "Ben" -- did it for journalism. That is, he attempted to do it for journalism.
Beyond the first obstacle (abject fear) lurked the screening process. "We test for marijuana going back six months," a Gateway staffer says ominously when Ben calls to inquire about upcoming studies at the 50,000-square-foot facility, located just off Highway 370 in St. Charles. Nevertheless, Ben is inclined to push forward. (The $500 payment for participation is a factor.)
But first he pumps Hoyt for more information.
"You check in at 7 p.m., and then lockdown begins," the blue-eyed, curly-haired blonde imparts. "I hate to call it 'lockdown,' but you're unable to leave. You can leave, but then you forfeit your money.
"'No hanky-panky to be happening,' is explained when you check in,'" she continues. "And they also basically say 'no making out on the couches' and have a 'no laying down on the couch' rule."
But you deal with it.
"They have two big-screen TVs, satellite and 500 movies to pick from. Usually one of the TVs has sports, and the other has a movie," Hoyt says. You can play pool on the center's bright red table, bring your PS2, headphones, laptop, board games, homework, magazines, whatever you want, she adds -- except pornography or your own videotapes. There's also a "quiet" room, a smoking lounge and private showers.
The bad part comes when you take the drug -- which in Hoyt's case was delivered as pills or a syrup. Generally, Gateway tests generic versions of drugs that have already been approved by the United States Food and Drug Administration (FDA) for conditions such as Parkinson's disease, depression, heart trouble or ulcers. Ingestion is followed by four hours of sitting in one place and a barrage of blood draws. In one study, Hoyt recounts, blood samples were taken 42 times over two sessions. "You get a needle stuck in your arm every fifteen minutes -- it kind of sucks," she says. "I usually switch arms halfway through. Whenever I go to the doctor now, I say, 'I just want you to know, I'm not a heroin addict.'"
But it doesn't have to be all bad. You might get lucky and get a fun drug. Once Hoyt got hydrocodone, the soothing painkiller found in Vicodin that Brett Favre and William S. Burroughs both took a fancy to. At any rate, Hoyt says that knowing the substances have already been fully approved for use on humans makes her feel safer about her participation than she would otherwise.
Then you pass out.
"The beds are comfortable. The staff give you extra blankets -- they're really nice."
An expert of sorts, Hoyt participates in clinical trials as often as she can. If she has any advice, it's to be kind to your phlebotomist friend.
"If you're nice to them, they're nice to you. Otherwise they'll kick you out. You always want to be nice to somebody who's drawing your blood," she advises. "I saw them mark on someone's file who was arguing with one of the phlebotomists that he'd never be able to participate in one of the studies again. They have 6,000 people in their database, I've overheard, and in the past year they've doubled, so they're not hurting."
As a warm-up exercise for the Gateway sleepovers, "Ben" responds to an ad for a smallpox study at the Center for Vaccine Development at Saint Louis University. One little vaccination, and only a dozen or so blood draws over the course of the next few months -- how bad could it be? Besides, when all is said and done, he'll be able to withstand a bio-terror attack while his unvaccinated buddies perish before his eyes!
There's also the 600 bucks.
The vaccination is painless, the blood draws mundane. "I took a bath with an HIV-positive pregnant woman with eczema last night," Ben cheerfully informs a nurse -- knowing full well he's supposed to keep the vaccination site tightly bandaged and stay away from anyone whose immune system might be vulnerable.
She raises her eyebrows.
"Just kidding," he says, unaware that he'll be called in for a surprise EKG the following week and spend an entire night fretting that his heart is failing.
"You're fine," the nurse tells him afterward. "The person who did this last time must have done it wrong."
Rising from a maze of west-county highways whose digits all end in "70," the unassuming mass of Gateway Medical Center squats at the northern edge of St. Charles on Fountain Lakes Commerce Center Boulevard, neighbored by a Sleep Inn, a few sleepy-looking warehouses and, apparently, very little commerce. In addition to medical tests conducted each week on hundreds of volunteers at six clinics on these grounds, Gateway provides consulting services and helps design protocols for pharmaceutical companies looking to move their drugs to market.
"Ben," who has come for an initial screening, has been fasting all morning. The empty bird feeder and spent suet dispenser near the entrance bring to mind only one thing: food.
Summoning him promptly to the screening area, a genial phlebotomist pulls a few vials of blood and gives Ben a cup to pee into. That mission accomplished, he sets the uncovered receptacle on a countertop and receives a cold can of Vess Up, presumably for replenishment purposes. Then it's on to a quick tour of the facilities. The dorms -- one for women, and a much larger one for men -- are impeccably clean. The white sheets and symmetrical rows of bunk beds bring to mind a German youth hostel.
In the course of his research, Ben has learned that Gateway was founded in 1987 and moved to this greatly expanded facility in 2002. A multimillion-dollar, privately owned company, it's the only testing facility of its kind in St. Louis. Of course, that's just a drop in the approximately $6 billion-per-year domestic drug-testing bucket. Even when America is in a recession, the clinical-trial business balloons by about 10 percent each year. Estimates vary, but it's likely that tens of thousands of trials, involving millions of people, are currently taking place. Participants include the sick and the healthy, the young and the old, the rich and the poor.
Of course, drug trials aren't only about money. "The clinical trials of today are going to be helping the people of tomorrow," says Joe Muehlenkamp, spokesman for Saint Louis University. "Diseases for which there is no cure today, we're gonna have a cure, and new treatments tomorrow. This is a good thing. Medicine is getting better. We're coming up with new and better treatments for a variety of diseases -- cancer, infectious diseases, everything -- and it's because of these clinical trials we conduct."
Though trials for the healthy were by and large limited to adult men as recently as the early 1990s, beginning in 1993 the federal Food and Drug Administration instituted regulations designed to encourage the participation of as large a demographic as possible.
"Unless the drug is sex- or age-specific -- you're not going to study an Alzheimer's drug on kids, for example -- the FDA wants to see a broad population representation in clinical trials," explains Dr. Alan Goldhammer, associate vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, a Washington, D.C.-based trade association.
Goldhammer estimates that it takes twelve to fifteen years to bring a new drug to market, at a cost of more than $800 million. "About one out of every five thousand compounds that's looked at in the laboratory ends up getting to the marketplace," he notes, explaining that before a drug even reaches the clinical-trial phase, it must be experimented on in animal and human cells, and then extensively on animals.
"But the most expensive part of it is when you start the human clinical trials," says Goldhammer.
Typically, trials are conducted in three phases. Phase One studies usually involve only a few dozen healthy volunteers and focus on a drug's intended and unintended effects on the body. According to the FDA, about 70 percent of drugs are deemed safe and move on to Phase Two, where their effects are compared to those of patients who are given placebos. Phase Three aims to study a drug's effectiveness on the sick patients it's intended to help, and to identify adverse reactions. After completing the third phase of testing, a pharmaceutical company may request FDA approval.
Saint Louis University's Health Sciences Center and Washington University's School of Medicine are the human-clinical-trial behemoths in the area, operating trials in phases One, Two and Three. Unlike the medical schools, which are bankrolled in part by the National Institutes of Health, Gateway's studies are entirely privately funded. And because they involve generic versions of drugs that have already received FDA approval, they're considered to have gone beyond the three-phase process.
Joni Westerhouse, spokeswoman for Wash. U.'s School of Medicine, says that in 2003 the school had approximately 3,400 studies under way. She's unable to estimate the number of participants, but she says any given study might involve anywhere from one to one thousand subjects. SLU's Muehlenkamp says he is unable to gauge how many studies are under way there.
Back at Gateway, Ben's tour ends and the phlebotomist hands him a packet of papers that lay out the details -- and the do's and don'ts -- of the study he's signed up for.
Two weeks beforehand: no prescription medication. One week beforehand: no over-the-counter meds, and no herbal dietary supplements. One day beforehand: no caffeine, alcohol, chocolate, grapefruit or poppy seeds.
On the next page, entitled "Study profile," matters get more serious:
Description of Drug: Used for the treatment of Parkinson's Disease.
Most Commonly Reported Side Effects: Abnormal liver function; occasional reduction of white blood cell count, or red blood cell volume; loss of appetite, nausea, vomiting, abdominal pain, dry mouth, weakness, headache, dizziness, numbness, confusion, hallucinations, fatigue, anxiety, difficulty swallowing, taste disturbance, unusual movements, disturbance of blood clotting, diarrhea, constipation, back pain, sleepiness.
After musing about the difference between sleepiness and fatigue and wondering what 'taste disturbance' and 'unusual movements' might be, Ben concludes that at the very least, the diarrhea and constipation will cancel each other out.
No. of [blood] Samples: 18 per period.
Draw Times: 5:30 a.m., 7:30 a.m., 7:45 a.m., 8:00 a.m., 8:15 a.m., 8:30 a.m., 9:00 a.m., 9:30 a.m., 10 a.m., 10:30 a.m., 11:00 a.m., 12 p.m., 1 p.m., 2 p.m., 3 p.m., 5 p.m., 7 p.m. and 10 p.m.
Other miscellaneous notes:
Subjects #17-32 who do not eat the entire FDA High Fat Breakfast in the time allotted will be dropped.
This is underlined.
Subjects who experience vomiting within 12 hours after dosing may be dropped.
An instructional interlude: Want to participate in a paid medical study? Who wouldn't?
A quick way to learn about studies in your area is to dial up www.centerwatch.org/patient/trials.html, a national database maintained by Thomson CenterWatch, a Boston-based information-services company. Also on the site are resources for would-be clinical trial participants, including a nice FAQ section that provides the basics on human trials. You can even sign up to be notified by e-mail when new studies are available.
In fact, if you're willing to travel and you have an ailment that fills the bill, CenterWatch allows you to check out studies that are actively recruiting patients at centers around the nation in fields such as "Dermatology/Plastic Surgery," "Musculoskelatal," "Otolaryngology" and "Psychiatry/Psychology."
A quick browse of this last category shows current studies available for patients beset by disorders ranging from "Kleptomania" to "Binge Eating," "Oppositional Defiant Disorder (ODD)," "Restless Legs" and "Social Anxiety Disorder (SAD)." One study solicits with a single simple question: "Menopause...has it changed your sexual life?"
CenterWatch is the fastest method for finding out about studies at WU and SLU (for the latter, you can also visit http://solutions.slu.edu/). The easiest way to volunteer at Gateway is to fill out an application at the company's Web site, www.gatewaymedical.com. If accepted, you're in the database, which means you can call in weekly to find out about new studies.
Eric Carter is a semi-professional lab rat. "I was messed up, man," the scraggly-goateed 23-year-old confides over a beer at Brandt's. Carter refers to a study he participated in last May, which netted him $800. "They hopped me up on OxyContin and let me do whatever -- walk around the hospital," he says. The drug, revealed last year as Rush Limbaugh's narcotic of choice, is known as "hillbilly heroin" in some circles. "Every hour I had to check in and give a blood sample, but for eight hours a day for four days, I basically had nothing to do except watching The Price Is Right, reading magazines, listening to music."
Carter picks up his Guinness, revealing the letters "SSS" -- for "South Side Saboteurs," he explains -- tattooed on the knuckles of his left fist. His expression takes on a nostalgic cast, the sort of fond faraway look one might display when recalling the senior prom. "I was in outer space," he says. "I loved it."
A native of Washington, D.C., Carter came to St. Louis a year and a half ago and now stays at the so-called Bolozone housing collective, an anarchists' nexus in south city that made news when several of its residents were arrested in advance of the World Agricultural Forum's convocation last year in St. Louis. He estimates the three test studies and one survey he took part in last year, all undertaken at Washington U.'s School of Medicine, accounted for half his annual income.
Carter, who works at a friend's guitar-assembly plant when he's not brimming with experimental drugs, says he tries to get into paid medical studies whenever possible. "The best part about them are the free STD screenings," he says.
But they haven't all been pleasant. The worst, he says, was an alcohol-and-tobacco study. Carter decided to participate in it partly because he'd heard through the lab-rat rumor mill that it required little more than sitting around smoking and getting drunk. Alas, the "smoking" involved unpleasant puffs from a nicotine nasal inhaler, while the "drinking" entailed rapid ingestions of an apple juice-like substance.
"They just give you four cups and say, 'Drink all four,'" he recounts. "You don't know which ones have alcohol in them, if any of them have alcohol in them. I did that three times, pretty much on an empty stomach. It was very disorienting. I was in a hospital, I wasn't moving around or anything, just sitting there reading magazines. I didn't know how drunk I was."
Compared to the experience related by "Timothy," a twenty-year-old anarchist punk who preferred that his real name not appear in print, Carter's adventure sounds like a walk in the park. A resident of Lawrence, Kansas, Timothy says he once participated in a study where he was given (and subsequently cured of) gonorrhea.
"It kinda sucked," understates the unkempt, semi-professional lab rat, who can't remember precisely how many studies he's taken part in but estimates the number at somewhere between eight and ten. The way Timothy tells it, he was informed at the outset of the study that the odds he'd actually contract the sexually transmitted disease were one in four, with the others being control cases.
"I was the one," he says, wrinkling his brow. Clearly the painful memories remain. "It burned when I peed," he says.
Veteran lab rat Robert Helms estimates he has participated in between 60 and 80 studies. The strangest one, Helms says, involved swallowing a capsule that contained a tiny object. "We ate the capsule, and then it dissolved inside the stomach, all except for a tiny piece of plastic -- or some cement material -- that your stomach couldn't dissolve," Helms recounts.
The study, which Helms underwent in the winter of 2002-03 in his hometown of Philadelphia, sought to measure how long it took the object to pass through a subject's digestive system. "We had to collect all our feces, and the nurse had to go through it with a little spatula -- a little ice-cream-stick kind of thing, and find that thing," says Helms.
The real booty was the pay: Helms says he was paid about $4,000 for the study, which lasted about six weeks.
Facilities that conduct paid medical trials aren't inclined to share information, so it's difficult to verify the tales told by human guinea pigs. Still, Helms probably serves as a pretty decent bullshit detector. For the past eight years, he has chronicled lab rats' painful and bizarre stories for his zine and Web site, Guinea Pig Zero (www.guineapigzero.com). In the process he has heard every test-study urban legend in the book. "You've got the one where they cut your toe off and they pay you 5,000 bucks, or the one where they stop your heart for 10,000 bucks," offers the 42-year-old writer, who's living in a Paris suburb while he writes a book about early Philadelphia anarchists. "Or they put you under general anesthesia for nine hours and pull you back out and pay you whatever. Some of them are probably just extended half-truths, some of them are totally fiction, some were more likely to happen in the former Soviet Union or some rogue operation in the Third World."
As for "Timothy" and his purported dose of the clap, Helms isn't buying. "I'm pretty skeptical of that," he says. "Why would they give him gonorrhea? Why wouldn't they find a guy who already had gonorrhea? I don't see it."
He got so sick of people's banal urban legends, says Helms, that he made up one of his own, which he tells to people he meets at studies. It goes like this:
"They're getting guys to eat the end of a cable coated with Teflon -- keep eating it until it comes out the rectum. Then it gets sterilized by the nurse. Then the next guy has to eat it, until ten guys are connected. They're using it to develop new methods of prisoner control, to keep people from running away."
When it comes to the clinical-trial industry, truth can be as harrowing as fiction -- from the infamous Tuskegee syphilis study, in which hundreds of black participants were allowed to get sick and even die despite the availability of a cure, to more recent tragedies.
In February a nineteen-year-old Pennsylvania woman hanged herself inside a testing center while testing an experimental antidepressant. She was attempting to pay her way through Bible college. Closer to home, a twenty-month-old girl died while taking experimental chemotherapy drugs in a Washington University clinical trial at Children's Hospital in 2002. Three other children died of the same side effect at other hospitals. Believing that their daughter Daniella could have survived if they'd been more accurately informed of the study's risks, John and Oksana Rogers set up a Web site (www.daniellarogers.org) devoted to educating parents of children who participate in drug trials. Last year the federal Office of Human Research Protection found that Washington U. should have done a more thorough job of warning about potential complications.
"In fact," John Rogers asserts, "there are more rights for animals than there are for children when it comes to research."
Rogers declines to discuss his dealings with Washington University; Joni Westerhouse, spokeswoman for Wash. U.'s School of Medicine, says the university's legal counsel instructed her not to comment about the matter.
Also in 2002, Saint Louis University courted controversy during a trial on a herpes vaccine. In recruiting test subjects, the university sought women who were sexually active or planning to become sexually active but who were not involved in monogamous relationships. The method so enraged SLU neurology professor William Burke that he penned an angry letter to the St. Louis Post-Dispatch, complaining that "in this case being a good subject means agreeing to repeatedly perform acts that are considered seriously immoral by the Catholic university that sponsors the experiment."
The following year the study's parameters were changed to allow monogamous women. Says SLU spokesman Joe Muehlenkamp: "The older parameters led to some confusion over just who was eligible for the trial -- which led to the misperception that we were looking for 'promiscuous women,' which we are not. We found that this unfortunate misperception discouraged some women from enrolling who otherwise were good candidates. So we made the changes to clear up the false perception."
The drug trials themselves present even more potential for perilous misperception, according to activists at the New York-based watchdog group Alliance for Human Research Protection. Vera Hassner Sharav, president of the alliance, argues that the drug-testing industry is fraught with lies and conflicts of interest. Often, Sharav contends, sick participants are "misled and told that [an experimental drug] is the only way to survive. They're told that this trial is state-of-the-art, that you get the best treatment. In fact, you do not get individual treatment in most clinical trials."
Healthy people may also be deceived, she argues. "Consent forms never disclose as fully as they're supposed to the risks involved," Sharav says. "They never tell you the truth."
Guinea Pig Zero's Robert Helms concurs. "It's routine to withhold information from test subjects -- it's the basic plan of action," he says. "They do not publish the results of studies that tell them something negative about their drug. They only publish the ones that help get the drug on the market."
That said, the industry is heavily regulated, with Institutional Review Boards (known as IRBs) composed of scientists, physicians and lay members of the community such as lawyers and priests overseeing each and every trial under the aegis of the FDA.
"They bring a collective wisdom to the evaluation of a research proposal, with an eye toward not only the quality of the science, but specifically with respect to the protection of the participants," says Dr. Greg Koski, a former director of the Office for Human Research Protections, an arm of the Department of Health and Human Services, which oversees all federally funded human clinical trials.
But Koski, who is now a professor at Harvard Medical School and serves as vice president for ethics and professional conduct for the American Academy of Pharmaceutical Physicians, acknowledges that IRBs aren't as effective as they should be. "There has been a huge growth in the numbers of IRBs over the years, but one of the problems is that there has been no system for keeping track of all of them. This raises some concern, because if in fact this board is appointed by an institution [performing the tests] and supported by an institution -- does that set up a situation in which the objectivity of the group could be compromised? Are they there to protect the interests of the institution, or of the participants?"
Washington University, Saint Louis University and Gateway each has its own IRBs -- and each organization maintains that its boards are committed to safe protocols and patient advocacy. "All research that involves people must be reviewed and approved by the IRB," asserts SLU's Muehlenkamp. "The purpose of the IRB is to assure the protection and welfare of volunteers in research projects. These IRBs are not contracted privately."
But increasingly, research is being outsourced overseas. Providence, Rhode Island-based Clinical Research Centers International (CRCI), for example, recently announced it was moving into Romania, joining overseas testing centers in India, Africa, South America and elsewhere around the globe.
Part of the reason the industry is moving abroad, Helms maintains, is to escape scrutiny.
"They're getting too much hassle from journalists, from doctors and families of people who are getting badly treated or killed in the U.S., and they're going places where populations are a softer target," the zine master says. "It's cheaper to do it in Eastern Europe, China, wherever, and they're under less pressure to follow the ethical guidelines."
An equally thorny aspect of the ethical issue involves the participants themselves. Even if all the potential dangers of a trial were clearly spelled out in consent forms, some participants would be at risk. Many lab rats who were interviewed for this story confessed that they don't always read their consent forms, and nearly all said they'd lied in order to be eligible to earn cash.
"They ask about your family history," says Alecia Hoyt. "The best thing to say is that everyone's okay and everyone's dandy, because that's what's going to get you into the study. If you start talking about mental-health issues and family issues, you likely won't be let into the study." [Editor's note: A correction ran concerning this paragraph; please see end of article.]
Alliance for Human Research Protection president Vera Hassner Sharav says she's particularly troubled by non-academic clinical settings such as Gateway. "Taking it into the commercial setting can only mean increased risk, fewer safeguards and skirting of safe methods," Sharav contends. "You can call them factories -- actually more like assembly-line studies."
Even worse, Sharav says, is the fact that some of these institutions rely heavily upon young people to fuel their studies. "Essentially they're exploiting students' lack of knowledge, lack of maturity, lack of skepticism," Sharav argues. "They're not wary. Students tend to be risk takers. The trouble is that this is their health, their bodies, and they don't know what some of the hidden risks may be."
Gateway president and founder Daniel R. Shipley did not return phone calls seeking comment for this story.
When "Ben" calls requesting information, he is directed to a spokeswoman for the company, who agrees to speak for the record only on the condition that her name not be published.
"No one has been significantly harmed from one of our studies," the spokeswoman says. She estimates that about one-third of those who participate in Gateway trials are students or people in their early twenties, but takes issue with the exploitative picture Sharav paints. "Number one, we don't have any hidden risks," she says. "Number two, we do not pinpoint that specific group. We just put the word out. We don't turn anybody away, unless of course they don't meet our criteria to do the studies. But we don't pinpoint that age."
Another subset of study participants, according to the Gateway spokeswoman, is the homeless. "That happens all the time and there's nothing we can do about it," she says. "I mean, their blood is just as good. That's why we do our screening process. We're not going to turn somebody away. I mean, it helps them out, it helps us out -- there's no harm in that as long as they pass our screening process."
And what about participants who use marijuana and other taboo substances? "Hopefully they'll weed themselves out [during the screening process]," she says, apparently oblivious to the pun. "Normally people who do drugs won't come in and do a drug screen."
Ben has pneumonia. Still, he has resolved to pursue the cash. (And the journalism, of course.)
But will Gateway's screeners permit a man with pneumonia to partake of Parkinson's medication?
Perhaps a better question is: Will a man with pneumonia be dumb enough to partake of Parkinson's medication?
A few minutes early, Ben slowly drives in circles around the facility's half-dozen clinics. Pulling over, he peers through Clinic 5's blinds, which are slightly askew. In the "quiet" room, two college joes are watching what appears to be a school-related video, while in the "smoking" room another handful of men blab and puff.
"I'm on antibiotics," Ben fesses up the instant a clipboard is placed in front of him by a smiling phlebotomist. She immediately retracts it and sends him to a stern-looking superior across the room.
The woman looks up from behind her desk. "What's wrong with you?" she asks accusingly.
Ben gulps. "I'm on antibiotics."
She shuffles papers for a minute, deliberating.
"I have pneumonia," he volunteers.
The nurse looks at Ben with an expression that makes it clear he has just set back the medical community several hundred years' worth of research.
"You can't participate," she declares, ignoring Ben's protestations -- "Can I get into another study sometime?" "I'm sorry!" -- and banishing him to the parking lot.
Correction published 5/19/04: The original version of this story contained a paraphrased statement about recreational drug use that was erroneously attributed to clinical-trial participant Alecia Hoyt. The above version reflects the retraction.