Nevada Senator Dean Heller (R-NV) encouraged doctors at a Reno-based Veterans Affairs medical center to use an off-label transcranial magnetic stimulation technology marketed by a company with connections to his office, according to a new ProPublica report.
The company, called CereCare, markets a technology it says uses electrical scans of the brain and heart to detect an “intrinsic brainwave frequency” to identify areas of the brain “in need of restoration,” according the the report. The areas are then targeted with stimulation from a TMS system.
The meeting was arranged because two partners at CereCare had a connection to a senior aide to Heller in Reno, according to ProPublica. Heller went on to co-sponsor a bill looking to start a pilot program on CereCare’s procedure.
CereCare partner Jodi Kosterman, who labels themselves as “Dr.” on their business cards despite having no medical degree, reportedly joined in drafting the bill, describing themselves as an expert on the procedure.
In consideration of the procedure being off-label, CereCare partner Nino Pedrini suggested that “the thing we all have to get over is FDA approval on some things,” according to ProPublica.
“You’ve got to try things. We can’t get hung up on 20 years of the FDA trying to approve something because of the bureaucracy and red tape,” Pedrini said, according to the report.
The pilot, and other such attempts to use experimental and off-label procedures with the VA have met with push back from mental health professionals, who strongly support the use of treatments that are scientifically validated, according to ProPublica.
The pilot program never moved forward, due to issues with clearances, approvals and reviews, according to the report.
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