Last week the New York Times and LA Times reported violations of FDA mandated dosage levels in the chemicals used in clinical PET (positron emission tomography) studies at a major lab, the Kreitchman PET Center, at the Columbia University Medical Center.
Most people who participate in experimental studies of drug treatments are vulnerable–either via poverty, mental illness, other disability, race–and while they consent to participate. That consent carries with it an acknowledgment of a higher risk, but it’s also based on the basic trust that the studies are at least in accord with federal and other regulations (e.g., university research ethics boards approvals, when done in university environments).
The practice of chasing “willing subjects” to all corners of the globe became widespread as these approvals onshore became harder to gain for domestic populations, a story told in The Constant Gardener that had at least one kind of less-than-fully-evil outcome, as reported last year by The Independent.
So what is going on at Columbia University? (apart from damage control by their administration) Below the fold is the LA Times article; here’s the link to the original article, and here’s a h/t link to the AHRP blog post by Vera on this story. Continue reading
