A national consumer advocacy group said University City-based Avid Radiopharmaceuticals helped write a misleading paper about an imaging agent it is developing to help identify plaque in the brain.
A January study in the Journal of the American Medical Association, with authors from Avid, did not include information on how well different doctors were able to spot the plaque highlighted by the dye.
The group Public Citizen said that made the imaging agent seem more effective than it really is at detecting the plaque, which can be a sign of Alzheimer’s.
“A substantial number of people could be incorrectly diagnosed as having these brain abnormalities on the scans, when they in fact don’t,” said Dr. Michael Carome, with the group’s health research arm. “Other patients could be told that they don’t have this abnormality when they, in fact, do.”
Avid’s Dr. Chris Clark said the study was designed only to determine if the imaging agent worked in making brain plaques visible on a scan, compared against findings of an autopsy.
“It was not designed, and never intended to, and cannot be used to determine how likely it is that one physician would interpret a scan as positive and negative and a second physician would come to either that conclusion or a different conclusion,” Clark said.
Individual reader score data was submitted to the Food and Drug Administration before the study was published. Earlier this year an FDA panel did not recommend the dye for approval, but said if doctor training efforts could be developed and proved effective at making the scan analysis more accurate, it may.
Eli Lilly bought Avid in November for $300 million.