Miami – Oscar Cabanerio has been waiting in an experimental-drug testing center since 7:30 a.m. The 41-year-old undocumented immigrant says he’s desperate for cash to send to his wife and four children in Venezuela.
Cabanerio is one of many regulars who gather at SFBC International Inc.’s test center, which, with 675 beds, is the largest for-profit drug-testing center in North America.
Most of the people lining up at SFBC to rent their bodies to medical researchers are poor immigrants from Latin America, drawn to this five-story test center in a converted Holiday Inn motel.
Inside, the brown paint and linoleum is gouged and scuffed. A bathroom with chipped white tiles reeks of urine; its floor is covered with muddy footprints and used paper towels. The volunteers, who are supposed to be healthy, wait for the chance to get paid for ingesting chemicals that may make them sick.
They are testing compounds that the world’s largest pharmaceutical companies hope to develop into best-selling medicines.
Cabanerio, who has a mechanical drafting degree from a technical school, says he left Venezuela because he lost his job as a union administrator. For him, the visit to SFBC is a last resort.
“I’m in a bind,” Cabanerio says in Spanish. “I need the money.”
Every year, Big Pharma, as the world’s largest drugmakers are called, spends $14 billion to test experimental drugs on humans. In the U.S., 3.7 million people have been human guinea pigs.
Few doctors dispute that testing drugs on people is necessary. No amount of experimentation on lab rats will reliably show how a chemical will affect people.
But medical success stories mask a clinical drug-trial industry that is poorly regulated, riddled with conflicts of interest – and sometimes deadly.
Drug companies distance themselves from the human experiments by outsourcing most of their trials to private test centers, says Daniel Federman, a doctor who is a senior dean of Harvard Medical School in Boston.
The U.S. Food and Drug Administration is the principal federal agency charged with policing the safety of human drug testing. But it has farmed out much of that responsibility to a network of private companies and groups called institutional review boards. These IRBs are paid by Big Pharma – just like the testing centers they’re supposed to be regulating.
The drug-experiment companies and the private-oversight firms have more incentive to satisfy pharmaceutical companies wanting speedy results than to ensure the safety of participants or integrity of research data, says Marcia Angell, editor in chief of the New England Journal of Medicine from 1999 to 2000.
The consent forms that people in tests sign – some of which say participants may die during the trial – are written in complicated and obscure language. Many participants interviewed say they barely read them.
SFBC chief executive Arnold Hantman says his center diligently meets all regulations.
“We take very seriously our responsibilities to regulatory authorities, trial participants, clients, employees and shareholders,” Hantman, 56, says.
