HEADLINES Published April13, 2015 By Bernadette Strong

FDA Warns Researchers on Claims for CTE Detecting Drug

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The FDA, part of the Department of Health and Human Services, has issued a warning letter to two researchers over apotential test for CTE.
(Photo : Manny Ceneta, Getty Images)

Last week came news that researchers at the University of California at Los Angeles may have created a test to detect chronic traumatic encephalopathy (CTE) using a biomarker that they had created. Now comes news that the U.S. Food and Drug Administration has issued a letter warning them that they may have improperly marketed the biomarker, which FDA considers to be an investigational drug, and overstated its potential effectiveness.

The biomarker is called FDDNP and it is used with a PET scan to identify deposits in the brain of a protein called tau. The researchers, Dr. Gary Small and Dr. Jorge Barrio, have just published a study that compared PET scan results of 14 professional football players with those of 24 patients with Alzheimer's disease and 28 healthy people with no significant cognitive problems. They found that the tau deposits in the brains of the football players were distinctly different and could be a marker for CTE.

The FDA had no problem with the release of this news, but Small and Barrio are partners in Taumark, a company that will be making FDDNP if it is ever approved. Taumark's website, which has been disabled, had made what the FDA deemed to be marketing, with claims about the usefulness and effectiveness of FDDNP in detecting CTE. Several pro football players have publicly said that they have CTE based on having had PET scans with FDDNP.

"Thus, these claims and presentations suggest in a promotional context that FDDNP, an investigational new drug, is safe or effective for such uses, when FDA has not approved FDDNP for any use," the agency's letter said.

CTE is a degenerative condition due to cumulative damage to the brain caused by repeated traumatic brain injury such as concussions. It is still not known why some people who have had concussions develop CTE and some do not.

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