Mount Sinai, a leading hospital network in New York City, has mounted an extraordinary behind-the-scenes campaign to blunt the fallout over revelations about its controversial research project in which brain biopsies are taken from patients undergoing deep brain stimulation, STAT has learned. That has included not only enlisting its own patients to defend the research but also seeking to stop a professional society of neurosurgeons from issuing a statement that could have jeopardized the research.
The campaign began after a STAT investigation disclosed that a Food and Drug Administration review concluded that Mount Sinai researchers were misleading patients and using a false justification to obtain the biopsies.
Mount Sinai researchers had claimed, in a patient consent form and in documents submitted to the FDA and the National Institutes of Health, that patients in the study do not lose any additional tissue than they would during standard DBS, a procedure used to ease the symptoms of certain neurological conditions. But a number of neurosurgeons consulted by both the FDA and STAT disputed that claim.
