Guinea-pigging.(clinical trials)

On September 11, 2001, James Rockwell was camped out in a clinical-research unit on the eleventh floor of a Philadelphia hospital, where he had enrolled as a subject in a high-paying drug study. As a rule, studies that involve invasive medical procedures are more lucrative--the more uncomfortable, the better the pay--and in this study subjects had a fibre-optic tube inserted in their mouths and down their esophaguses so that researchers could examine their gastrointestinal tracts.

Rockwell had enrolled in many previous studies at corporate sites at places like Wyeth and GlaxoSmithKline. But the atmosphere there felt professional, bureaucratic, and cold. This unit was in a university hospital, not a corporate lab, and the staff had a casual attitude toward regulations and procedures. "The Animal House of research units" is what Rockwell calls it. "I'm standing in the hallway juggling," he says. "I'm up at five in the morning watching movies." Although study guidelines called for stringent dietary restrictions, the subjects got so hungry that one of them picked the lock on the food closet. "We got giant boxes of cookies and ran into the lounge and put them in the couch," Rockwell says. "This one guy was putting them in the ceiling tiles." Rockwell has little confidence in the data that the study produced. "The most integral part of the study was the diet restriction," he says, "and we were just gorging ourselves at 2 A.M. on Cheez Doodles."

On the morning of September 11th, nearly a month into the five-week study, the subjects gathered around a television and watched the news of the terrorist attacks through a drug-induced haze. "We were all high on Versed after getting endoscopies," Rockwell says. He and the other subjects began to wonder if they should go home. But a mass departure would have ruined the study. "The doctors were, like, 'No, no!' " Rockwell recalls. " 'No one's going home, everything's fine!' " Rockwell stayed until the end of the study and was paid seventy-five hundred dollars. He used the money to make a down payment on a house.

Rockwell is a wiry thirty-year-old massage-therapy student with a pierced nose; he seems to bounce in his seat as he speaks, radiating enthusiasm. Over the years, he estimates, he has enrolled in more than twenty studies for money. The Philadelphia area offers plenty of opportunities for aspiring human subjects. It is home to four medical schools and is part of a drug-industry corridor that stretches into New Jersey. Bristol-Myers Squibb regularly sends a van to pick up volunteers at the Trenton train station.

Today, fees as high as the one that Rockwell received aren't unusual. The best-paying studies are longer, in-patient trials, where subjects are often required to check into a research facility for days or even weeks at a time, so that their diet can be controlled, their blood and urine checked regularly, and their medical status carefully monitored. Occasionally, they also undergo invasive procedures, like a bronchoscopy or a biopsy, or something else unpleasant, such as being deprived of sleep, wearing a rectal probe, or having allergens sprayed in their faces. Because such studies require a fair amount of time in a research unit, the subjects are usually people who need money and have a lot of time to spare: the unemployed, college students, contract workers, ex-cons, or young people living on the margins who have decided that testing drugs is better than punching a clock with the wage slaves. In some cities, like Philadelphia and Austin, the drug-testing economy has produced a community of semi-professional research subjects, who enroll in one study after another. Some of them do nothing else. For them, "guinea-pigging," as they call it, has become a job. Many of them say that they know people who have been travelling around the country doing studies for fifteen years or longer. "It's crazy and it's sad," one drug-trial veteran told me. "For me, this is not a life. But it is a life for a lot of these people."

Most drug studies used to take place in medical schools and teaching hospitals. Pharmaceutical companies developed the drugs, but they contracted with academic physicians to carry out the clinical testing. According to The New England Journal of Medicine, as recently as 1991 eighty per cent of industry-sponsored trials were conducted in academic health centers. Academic health centers had a lot to offer pharmaceutical companies: academic researchers who could design the trials, publications in academic journals that could help market the products, and a pool of potential subjects on whom the drugs could be tested. But, in the past decade, the pharmaceutical industry has been testing more drugs, the trials have grown more complex, and the financial pressure to bring drugs to market swiftly has intensified. Impatient with the slow pace of academic bureaucracies, pharmaceutical companies have moved trials to the private sector, where more than seventy per cent of them are now conducted.

This has spurred the growth of businesses that specialize in various parts of the commercial-research enterprise. The largest of the new businesses are called "contract research organizations," and include Quintiles, Covance, Parexel, and P.P.D. (Pharmaceutical Product Development), a company that has operations in thirty countries, including India, Israel, and South Africa. (About fifty per cent of clinical trials are now conducted outside the United States and Western Europe.) These firms are hired to shepherd a product through every aspect of its development, from subject recruitment and testing through F.D.A. approval. Speed is critical: a patent lasts twenty years, and a drug company's aim is to get the drug on the shelves as early in the life of the patent as possible. When, in 2000, the Office of the Inspector General of the Department of Health and Human Services asked one researcher what sponsors were looking for, he replied, "No. 1--rapid enrollment. No. 2--rapid enrollment. No. 3--rapid enrollment." The result has been to broaden the range of subjects who are used and to increase the rates of pay they receive.