Chapter One
The Guinea Pigs

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 fiber-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, 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 two a.m. on Cheez Doodles.”

On the morning of September 11, 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 has enrolled in more than twenty studies for money, he estimates. 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 from there 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 in 2001 aren’t unusual. The best-paying studies are longer, inpatient trials, where subjects are often required to check into a research facility for days or even weeks at a time so that their diets can be controlled, their blood and urine tested regularly, and their medical status carefully monitored. Occasionally, they also undergo invasive procedures, like bronchoscopies or biopsies, or suffer through 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 usual subjects are 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 semiprofessional 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 traveling 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.”

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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, 80 percent of industry-sponsored trials were conducted in academic health centers. Academic health centers had a lot to offer pharmaceutical companies: researchers who could design the trials, publications in reputable 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 or so, 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, which is where more than 70 percent of them were conducted in 2004.

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 (CROs) and include Quintiles, Covance, Parexel, and PPD (Pharmaceutical Product Development), a company that has operations in thirty countries, including India, Israel, and South Africa. These firms are hired to shepherd a product through every aspect of its development, from subject recruitment and testing through FDA 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. In 2000, when the Office of Inspector General of the Department of Health and Human Services asked one researcher what sponsors were looking for, he replied, “Number one—rapid enrollment. Number two—rapid enrollment. Number three—rapid enrollment.”

The result has been a broadening of the range of subjects who are used and an increase in the rates of pay they receive.

Most professional guinea pigs are involved in Phase I clinical trials, in which the safety of a potential drug is tested, typically by giving it to healthy subjects and studying any side effects that it produces. (Phase II trials aim to determine dosing requirements and demonstrate therapeutic efficacy; Phase III trials are on a larger scale and usually compare a new drug’s results with those of standard treatments.) The better trial sites offer such amenities as video games, pool tables, and wireless Internet access. If all goes well, a guinea pig can get paid to spend a week watching The Lord of the Rings and playing Halo with his friends in exchange for wearing a hep-lock catheter in one arm and eating institutional food. Nathaniel Miller, a Philadelphia drug-trial veteran who started doing studies in order to fund his political activism, was once paid fifteen hundred dollars in exchange for three days and two endoscopies at Temple University, where he was given a private room with a television. “It was like a hotel,” he says, “except that twice they came in and stuck a tube down my nose.”

The shift to the market has created a new dynamic. The relationship between testers and test subjects has become, more nakedly than ever, a business transaction. Guinea pigs are the first to admit this. “Nobody’s doing this out of the goodness of their heart,” Miller says. Unlike subjects in later-stage clinical trials, who are usually sick and might enroll in a study to gain access to a new drug, people in healthy-volunteer studies cannot expect any therapeutic benefit to balance the risks they take. As guinea pigs see it, their reason for taking the drugs is no different from that of the clinical investigators who administer them and who are compensated handsomely for their efforts. This raises an ethical question: what happens when both parties involved in a drug trial see the enterprise primarily as a way of making money?

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In May of 2006, Miami-Dade County ordered the demolition of a former Holiday Inn, citing various fire and safety violations. It had been the largest drug-testing site in North America, with six hundred and seventyfive beds. The operation had closed down earlier that year, shortly after the financial magazine Bloomberg Markets reported that the building’s owner, SFBC International, was paying undocumented immigrants to participate in drug trials under ethically dubious conditions.3 The medical director of the clinic had gotten her degree from a school in the Caribbean and was not licensed to practice. Some of the studies had been approved by a commercial ethical review board owned by the wife of an SFBC vice president. (The company, which has since changed its name to PharmaNet Development Group, says that it required subjects to provide proof of their legal status, and that the practice of medicine wasn’t part of the medical director’s duties. In August 2007 the company paid [...] million to settle a class-action lawsuit.4)

“It was a human-subjects bazaar,” says Kenneth Goodman, a bioethicist at the University of Miami who visited the site. The motel was in a downtrodden neighborhood; according to later reports, paint was peeling from the walls, and there were seven or eight subjects in a room. Goodman says that the waiting area was filled with potential subjects, mainly African American and Hispanic; administrative staff members worked behind a window, like gas-station attendants, passing documents through a hole in the glass.

The SFBC scandal was not the first of its kind. In 1996, the Wall Street Journal reported that at its testing site in Indianapolis, Eli Lilly and Company was...