The U.S. Food and Drug Administration recently instructed a pair of UCLA researchers to stop promoting an experimental brain scan that uses an unapproved drug to detect long-term neurological damage.
The website of the researchers’ company, TauMark, suggested brain scans could detect concussions, dementia and other neurological conditions in patients who were injected with a short-lived radioactive compound.
Gary Small, a UCLA psychiatrist, and Jorge Barrio, a UCLA biochemist and imaging expert, are partners in TauMark, which owns the rights to the unapproved radioactive compound FDDNP used in the scans.
The FDA ordered Small on Feb. 20 to remove promotional materials from the website, saying that they misrepresented FDDNP. In a letter, the agency cited several instances in which the company’s site made conclusive statements, calling the injection and brain scan “easy and safe,” though the compound lacks FDA approval.
Small and his research team published a study in the Proceedings of the National Academy of Sciences on April 6. Their findings suggested that a simple positron emission tomography scan could warn athletes early on of brain damage and its long-term consequences.
The research indicated that former football players who had abnormal deposits of tau, the protein the company is named for, had more extreme cognitive impairment.
The findings could allow for chronic traumatic encephalopathy, a neurodegenerative disease, to be diagnosed in live patients. In the past, the disease has only been recognizable in the deceased, according to the study.
TauMark’s site showed images of football players, a soldier and an elderly couple, with captions that suggested the use of FDDNP in brain scans would protect individuals from head injuries and memory loss. The pages on the site that the FDA said were in violation of the Federal Food, Drug and Cosmetic Act have since been removed.
Small did not immediately respond to phone or email requests for comment.
UCLA officials asked TauMark to stop promoting the product, the university said in an email statement.
Lane Dilg, UCLA’s lawyer representing the researchers, did not respond to a request for comment. Dale Tate, a UCLA spokeswoman for the UCLA Health System, said there is no reason for the university to pursue disciplinary action against the researchers.