Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show

This two-year investigation was produced in collaboration with students at the Craig Newmark Graduate School of Journalism at the City University of New York who have since graduated. Audrey Carleton, Bruce Gil, Emily Nadal, and Zachary Smith contributed to this report.

N EW YORK — By the time Peter Bauman considered deep brain stimulation, he was desperate. Early onset Parkinson’s disease, diagnosed at age 49, had disabled him, ended his bartending career, and led him to consider suicide.

He hoped that the treatment, known as DBS, in which an electrode connected to an external battery is inserted into the brain and emits electrical impulses, would ease his Parkinson’s tremors.

In March 2020, as Bauman was preparing to undergo the surgery at a Mount Sinai medical facility in midtown Manhattan, he said he was invited to participate in a research study — one only open to patients already committed to undergo DBS at Mount Sinai. Over the course of two DBS procedures, a neurosurgeon would take up to a 1-cubic-centimeter piece of tissue from both the left and right sides of the brain, to use for research. In study documents, Mount Sinai doctors said the biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized.

Referred to at Mount Sinai as the Living Brain Project (LBP), the research aims to be the largest-ever molecular study of the living human brain, according to a National Institutes of Health grant application. While most research on the human brain is conducted on postmortem tissue, the researchers behind the LBP say the study of living tissue can help revolutionize our understanding of human brain biology.

Leave a Comment