By Sam Levin
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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.
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