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Showing posts with label Carl Elliott. Show all posts
Showing posts with label Carl Elliott. Show all posts

Sunday, February 3, 2008

Fast cash: Adverse effects of drug trials on human guinea pigs

Journalist Carl Elliott interviewed several human guinea pigs for a story in the New Yorker. One Iraqi man, living in Canada, began doing trials when he emigrated to Canada. He was living in a hostel and needed money to buy a car. A friend told him, "This is fast cash." When he enrolled in an immuno-suppressant trial at a Montreal-based subsidiary of SFBC, he found himself in bed next to a subject who was coughing up blood. Despite his complaints, he was not moved to a different bed for nine days. He and eight other subjects later tested positive for tuberculosis.

A human guinea pig in another drug trial had an even grimmer outcome. Traci Johnson, a previously healthy 19-year old student, committed suicide in a safety study of Eli Lilly's antidepressant Cymbalta in January, 2004. (Lilly denies its product was to blame.)

Alan Milstein, a lawyer in Philadelphia who has represented several human subjects, says about human guinea pigging: "This is not something you or I do. This is something the poor do so that the rich can get better drugs."

Advice to human guinea pigs: Read the fine print carefully to learn your rights.


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

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

Friday, January 18, 2008

The Animal House of drug research units: Human subjects – guinea pigs

On Sept. 11, 2001, James Rockwell was camped out in a clinical-research unit on the 11th floor of a Philadelphia hospital, where he had enrolled as a subject in a high-paying drug study. As a rule, studies that involved 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 cold examine their gastrointestinal tracts.

James 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 James calls it. "I'm standing in the hallway juggling," he says. "I'm up at 5:00 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," James says. "This one guy was putting them in the ceiling tiles." James 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 am on Cheez Doodles."

On the morning of Sept. 11, nearly a month into the five-week study, the subjects gathered around a TV and watched the news of the terrorist attack through a drug-induced haze. "We were all high on Versed after getting endoscopies," James 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!'" James recalls. "No one's going home, everything’s fine!" James stayed until the end of the study and was paid $7,500. He used the money to make a down payment on a house.

Over the years, James has enrolled in more than 20 studies for money. Today, fees as high as he received aren't unusual. Some people enroll in one drug study after another. For them, "guinea pigging" has become a job.

Browse for similar stories in our index at the very bottom of this page, or read another human guinea pig story.

Thanks to Carl Elliott for the source story In the Jan. 7 issue of the New Yorker.

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.