From STAT: “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.
Mount Sinai’s far-reaching efforts to defend its study, the Living Brain Project, included collecting statements from patients who effusively praised their medical care and objected to how they were quoted or described by STAT, despite the fact that they had confirmed those characterizations in interviews prior to publication. One of the patients Mount Sinai contacted, Peter Bauman, told STAT that the study’s lead neurosurgeon, Brian Kopell, prodded him to help seek a retraction and that he was ‘really freaked out’ by the exchange. As he recalled thinking, ‘I’m just wondering why he was really so worried about it if he didn’t do something wrong.’
Then, in early June, Mount Sinai attempted to quiet fallout from STAT’s reporting at the biennial meeting of the American Society for Stereotactic and Functional Neurosurgery (ASSFN), a premier professional society for neurosurgeons who treat movement-related and other quality-of-life disorders.
As the group’s members gathered in Nashville, its board of directors deliberated on whether to issue a statement about the Living Brain Project disclosures that would specify that standard DBS does not routinely involve removal of brain tissue, according to several sources who learned of the discussions. The statement threatened to undercut Mount Sinai’s justification for the study.
The board members were unified in agreeing that DBS — in which an electrode connected to an external battery is inserted into the brain and emits electrical impulses — does not involve the intentional removal of tissue, said the sources, who like others spoke on condition of anonymity. But the board’s discussions were influenced by the belief that Mount Sinai had made ‘very thinly veiled’ threats of legal action against the group if it released a statement that was harmful to the research study, as one of the sources put it.
‘The implication was, ASSFN couldn’t afford the lawyers to fight Sinai,’ said another of the sources.”
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