Researchers inject the mentally ill with dangerous impurities after warnings from FDA: Sunday news and blogs

  • Studies Halted at Brain Lab Over Impure Injections — NYT — Injecting tpeople labeled with mental illness with impure substance. Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities. — The investigations found that the center — regarded by experts as the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research — repeatedly violated Food and Drug Administration regulations over a four-year period.
  • More coverage of the above story at AHRP (Alliance for Human Research Protection) — In December 2008, the FDA warned Columbia that “failure to promptly correct these violations may result in legal action without further notice.” Columbia administrators ignored the warning. Thereby validating the claim made by an employee in his letter of resignation (2009): “These are not actions of a rogue, but instead are systematic forgeries condoned and approved by the lab director.” —The investigation found “at least 10 batches” of drugs had been “released and injected into human subjects” with impurities that exceeded the level the lab had agreed to set. At least four injections “had impurity masses that more than doubled the maximum limit implemented.The researchers undermined both patient safety and the scientific validity of the research–rendering the Columbia’s PET research invalid and unethical. — Inasmuch as Columbia is a major recipient of federal research monies, a Congressional investigation is called for.

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