Public Citizen is charging that Eli Lilly purposefully withheld data which demonstrated the unreliability of Amyvid, its experimental new imaging drug for Alzheimer's, when it submitted a study to the Journal of the American Medical Association. According to the consumer advocacy group, which has been harshly critical of the pharma industry over the years, Lilly excluded data--which was given to the FDA--which demonstrated that the ability to properly interpret brain scans varied from one physician to the next.
"FDA analyses of these data show substantial interreader variability among independent, extensively trained readers of the florbetapir-PET scans for individuals in the autopsy cohort," wrote Dr. Michael Carome and Sidney Wolfe, "emphasizing that florbetapir-PET imaging fails to provide an accurate and reliable assessment of amyloid burden."
Analysts have been paying close attention to Amyvid's fate. Eli Lilly bought Avid Radiopharmaceuticals for $300 million to obtain control of the Alzheimer's test. CEO John Lechleiter has vowed to gain full regulatory approval of Amyvid, which has been called a groundbreaking new approach to diagnosing Alzheimer's. Reuters reports that Lilly flatly denied doing anything improper.
"By withholding important information, the authors misled the journal and its readers to believe that this test for identifying brain abnormalities was more reliable than it actually is," noted Carome, deputy director of Public Citizen's Health Research Group, in a letter published in JAMA. "Given what is known about Alzheimer's disease and the lack of effective treatments, any proposed test for diagnosing this disease must be proven to be highly accurate in large, rigorously conducted studies before it is approved by the FDA for marketing."