FDA forces UCLA researchers to stop touting experimental dementia scan
The federal government has forced two UCLA researchers to stop making promotional claims about an experimental brain scan they hope to commercialize as a test for Alzheimer’s disease, long-term damage from traumatic brain injuries and other neurological conditions.
The website for their fledgling company, Taumark, suggested that injecting patients with FDDNP — an experimental, short-lived radioactive compound — and scanning their brains could offer early detection of concussions and various forms of dementia.
The site featured photographs of football players, a soldier and an elderly couple. One caption read: “Protecting our athletes who want to know about the consequences of concussive brain injuries.”
The U.S. Food and Drug Administration found that the claims violated a law against promoting unapproved drugs, in this case, FDDNP. In a Feb. 20 letter to Dr. Gary Small, a UCLA psychiatrist and partner in Taumark, the agency ordered the university — which holds the federal approval needed to conduct clinical trials using the drug — to remove the material.
In response, the company pared down the website to one sentence about “an experimental imaging probe” and links to scientific papers. On Friday, the site was not functional.
Small, who studies memory and aging, is the author of self-help books on brain health. His research and business partner, Jorge Barrio, is a UCLA biochemist and imaging expert.
Neither responded to requests for comment.
The researchers made news this week with a study of 14 retired National Football League players whose brain scans using FDDNP showed protein deposits that were consistent with chronic traumatic encephalopathy, or CTE, a poorly understood condition at the center of controversy over the dangers of contact sports.
CTE involves cognitive and psychiatric difficulties and appears to be caused by repeated blows to the head in combination with other unknown factors.
The brains of victims are riddled with tangled deposits of the protein tau, which can only be identified with certainty under a microscope after death.
In February 2013, after a team led by Small and Barrio published a study of brain scans, using FDDNP, of five ex-NFL players, the researchers were flooded with requests for scans from other former professionals as well as parents of high-school athletes.
Taumark was incorporated the next month.
The partners also include Dr. Bennet Omalu, a pathologist who identified the first case of CTE in a deceased NFL player, and Robert Fitzsimmons, a West Virginia lawyer who represented that player and is a co-author on the new study. The player was former Pittsburgh Steeler Mike Webster.
In 2014, the researchers received a publicity boost when Tony Dorsett, a former star NFL running back, announced that a scan showed he has CTE.
Outside experts have cautioned that the test remains unproven with no clear value outside of research. Autopsies show that protein tangles are sometimes present in people without cognitive or psychiatric symptoms, and there is no recommended course of action for people with worrisome scans.
The researchers themselves described the results as preliminary. But the website for Taumark suggested otherwise.
“Despite the devastating consequence of traumatic brain injury and the large number of athletes, military personnel and other head trauma victims at risk, until now, no method has been developed for early detection or tracking of the brain pathology associated with these injuries,” it said.
The website seemed geared toward attracting investors. It does not appear that the test has been used outside of research protocols.
While some language on the website suggested that the technique was still in development, the FDA letter to Small called the promotional elements “concerning from a public health perspective.”
In a March 27 response to the agency, a UCLA lawyer said that the university had “instructed Taumark to refrain from any activities that would constitute impermissible commercialization.”
A spokesperson for UCLA said the university is not currently pursuing disciplinary action.
The technique relies on the ability of FDDNP to cling to protein deposits in the brain. The molecule is injected into a patient’s arm and travels throughout the body. A positron emission tomography — or PET — scan measures the accumulation of radioactivity in the brain to pinpoint the proteins.
Small, Barrio and other researchers developed and patented FDDNP more than a decade ago with the hope of commercializing it as a “probe” for beta-amyloid, which forms the hallmark plaques in the brains of Alzheimer’s patients.
But the molecule adhered to too many other types of proteins as well. The researchers eventually recast FDDNP as a broader marker.
In patients with a history of head trauma, researchers deduced that the deposits are mainly tau.
In the paper published this week, the researchers found scan patterns in the 14 former football players were distinct from those in 24 patients with Alzheimer’s disease. Subjects without cognitive impairment had a different pattern.
Experts not involved in the research said the work advanced the 2013 paper but at best was a small step toward developing diagnostic scans for conditions that currently can only be seen in autopsies.
“The whole field is in a very early state since we don’t even know what CTE is,” said Dr. Douglas Smith, a traumatic brain injury researcher at the University of Pennsylvania. “Instead of having everybody in a mad dash to get a scan, we need to vet these tests so they are validated.”
At least two other molecules targeting tau are currently being tested in clinical trials.
In 2012, the FDA approved a radioactive probe for beta-amyloid. It is used mainly to identify people who may be at risk for dementia for inclusion in clinical trials — not to diagnose patients — and is not covered by Medicare.
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