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Tuesday, January 15, 2008

Managers threatened to have them deported: Human guinea pigs

The most notorious recent disaster affecting healthy human "guinea pigs" took place in March 2006, at a testing site run by Parexel at Northwick Park Hospital, outside London. Parexel offered human subjects 2,000 British pounds to enroll in a Phase I trial of a monoclonal antibody, a possible treatment for rheumatoid arthritis and multiple sclerosis. Six human subjects required care in the Intensive Care Unit (ICU) after suffering life-threatening reactions, e.g., severe inflammation and organ failure. They were hospitalized for weeks. One subject's fingers and toes had to be amputated. All of them have long-term disabilities.

It's not clear whether Parexel is paying for the required health care for the injured human subjects. At least some contract research organizations do not do so.

SFBC International offers one such example. It conducted a two-month study of the pain medicine Palladone, offering subjects $2,400. SFBC reserved the right to penalize subjects whom it dropped from the study because of the drug's side effects. SFBC (now known as PharmaNet Development Group) paid their human subjects most of their compensation only after they completed all four of the study's confinement periods. When its undocumented immigrant guinea pigs talked to the press, managers threatened to have them deported, according to Bloomberg Markets. PharmaNet settled a lawsuit for $29 million in August.

Advice to those considering whether to be human subjects in clinical drug trials: Read other guinea pigs' stories first.

Browse for related stories in the index at the very bottom of this page, or read a shocking story about a human guinea pig.

Thanks to Carl Elliott for the source article in the Jan. 7 issue of the New Yorker.

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