Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show By Katherine Eban May 1, 2024

https://www.statnews.com/2024/05/01/brain-biopsies-mount-sinai-fda-review/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--TD3kXabGKCzUDua1eRmgQZfEtnCvWajzQfZgfaLFhpNo3qBDjg7CBjZVJDrDFsy58ktMmPY6H0HgFoNUCNrTOto6UNQ&_hsmi=305080140&utm_content=305080140&utm_source=hs_email Peter Bauman was desperate to ease the symptoms of his early onset Parkinson’s disease when he decided to undergo deep brain stimulation, a procedure in which an electrode is inserted into the brain and emits electrical impulses. In March 2020, as he prepared to undergo the procedure at Mount Sinai in Manhattan, he was invited to participate in a research study. During the operation, he agreed, a neurosurgeon would take up to a 1 cubic centimeter piece of tissue from each side of his brain. His sample would go toward the Living Brain Project, which aims to be the largest-ever molecular study of the living human brain (most brain research is conducted on postmortem tissue). “I don’t remember them mentioning anything that it would hinder or harm,” Bauman said. But more than 3,500 pages of federal agency documents, dozens of pages of internal Mount Sinai documents, and interviews with over 60 sources suggest that patients like Bauman may have been given a “false justification,” as determined by an FDA review, for the removal of brain tissue. Read the story from STAT contributor Katherine Eban about the still-ongoing project, and why federal regulators were concerned. You can also read all the questions STAT sent to Mount Sinai about the research, along with the institution’s answers. https://www.statnews.com/2024/05/01/living-brain-project-mount-sinai-responses-stat-questions/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_dgV6xlTQaunA4yg6D-jA83iAAzJZ7LEFt_J-WBG6p1WpPc79toZwlw-18Ppj-3a67nHa4M9h8uWWEHDIlJAq1S0qJzg&_hsmi=305080140&utm_content=305080140&utm_source=hs_email