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Brain biopsies on vulnerable patients at Mount Sinai set off alarm bells at FDA, documents obtained by grantees show

Mike Reddy for STAT

Researchers at Mount Sinai medical center used a false justification for taking brain tissue from vulnerable patients, according to a two-year investigation by STAT News, with support from the Fund. FDA reviewers determined in an internal report that “investigator-physicians are abusing or exploiting the trust of their patients,” the investigation found. The brain biopsies were taken from living patients undergoing deep brain stimulation in order to make research discoveries. The STAT News investigation began as a research project led by Katherine Eban with her investigative health students at the Craig Newmark Graduate School of Journalism at CUNY. The investigation was based on more than 3,500 pages of documents from multiple federal agencies, obtained through Freedom of Information litigation.