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Thursday 3 January 2008

Guinea-Pig Ethics

09:31
Carl Elliott’s excellent article on “Guinea-Pigging” in the forthcoming January 7 New Yorker (only the abstract is available on-line) educated me about a topic I should have known about already – the inner workings of pharmaceutical contract research organizations.

Over the past decade, pharmaceutical companies have increasingly outsourced the conduct of clinical trials to contract research organizations. CROs are big business. Revenues are estimated at close to $18 billion. The largest 10 firms enrolled more then 640,000 subjects in trials in 2004.

“Guinea-Pigging” is the insider term for the job of research subject in a CRO project. This isn’t volunteering from altruistic motives as patients of mine with HIV and cancer have done to contribute to scientific progress in an area they care about. It is a job, and not an elevated one. A guinea pig for a sleep study described the work as a form of prostitution – “I would sell my body not to slobbering johns who assail the street whore with their unkempt organs, but to slick, white coated neuropsychologists who use thrice sterilized catheters, electrodes…and invasive thermometers to get what they want.”

Readers who, like me, do not yet know in any detail about the recruitment of healthy subjects for CRO studies can visit Guinea Pig Zero, defined as a "jobzine for people who are used as medical or pharmaceutical research subjects." And, as well, websites for large CROs, such as Pharmaceutical Product Development, Charles River Laboratories, and Covance.

CROs are at the heart of the development of new treatments, but they have largely been under the radar in terms of recognizing just how important they have become. Subject recruitment is becoming a worldwide industry. I look forward to learning more about the area in the next few months. We owe Carl Elliott thanks for bringing questions about the ethics of the role -- safety, compensation, and non-exploitation, to the fore.

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