(STAT News) – What Bauman couldn’t have known was that roughly one year earlier, the Mount Sinai brain biopsies had set off alarm bells at the Food and Drug Administration, whose review had been triggered when a device manufacturer wrote to the agency in April 2019. The manufacturer requested approval to modify an electrode Mount Sinai was using in its Living Brain Project, in order to briefly record certain brain activity. In late 2013, the FDA had conditionally approved the biopsies as a part of an early feasibility study, which it limited to six patients at the medical center who were getting DBS for treatment-resistant depression.

The FDA’s months-long internal examination of the LBP yielded a series of documents seen by STAT, including a lengthy review, completed in August 2019, of the Mount Sinai study. The review, which lists consultations with 16 different FDA officials, was scathing. It determined that the Mount Sinai doctors had been using a “false justification” to obtain patient consent to take the biopsies. (Read More)