How Safe Are Drug Trials for Participants?

ByABC News via logo
November 2, 2005, 7:33 AM

Nov. 2, 2005 — -- Nearly 4 million Americans each year become human guinea pigs when they volunteer to be subjects in drug trials. Universities used to handle most of these trials, but now they're mostly done by private, profit-driven testing centers. Every year, human testers get sick or die during these drug trials, but no one knows how many because nobody tracks that number, explains GMA consumer correspondent Elisabeth Leamy.

Gary Polsgrove, an ex-Marine, was one of those who died. He was enrolled in a trial of a generic schizophrenia drug at the Fabre Research Clinic in Houston.

"I think, you know, he was truly mistreated," said Nancy Gatlin, Polsgrove's older sister.

Polsgrove was homeless and unemployed when he enrolled in the study, but was physically healthy. He signed up to get a bed and some cash. He was kept on the drug even after he developed adverse reactions, and died of heart swelling after 23 days in the clinic.

IVAX, the company that sponsored the drug trial in which Polsgrove died, points out the Food and Drug Administration took no action against it.

"The consent form disclosed the cardiovascular risk," the company said in a statement. "IVAX believes we have fully complied with all applicable rules and regulations."

Almost three years after Polsgrove died, the FDA sent the Fabre clinic a letter accusing it of violating the rules to conduct proper drug trials. Clinic owner Dr. Louis Fabre denied wrongdoing but shut down the clinic in April. Fabre did not respond to ABC's request for comment.

The FDA says the drug trial system is safe.

"We believe the system is safe human subject experiments always carry a small degree of risk," said a spokesman for the FDA.

But Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, believes drug trials are filled with conflicts of interest.

"The ethics of clinical research has become grim," Caplan said. "I'm actually frightened about it."

Bloomberg News reports that pharmaceutical companies most often hire private clinics or doctors to do their trials. The drug companies also pay private independent review boards to monitor the studies.

"If you think about it, how can you trust someone to look out for your best interests if the person who's paying them is the sponsor of the study?" Caplan said.

Suggested reforms to the system include giving clear explanations to volunteers of exactly what the risks are, as well as a public national registry of drug trials with the results and the participants.