The article "Alzheimer Diagnosis Possible With Scan" published in the print edition of the Wall Street Journal Monday April 9
Majia here: When I saw this headline I was rather surprised because injecting radionuclides into brains doesn't sound like a good idea, even for the purposes of diagnosing a terrible disease such as Alzheimers.
Presently there is no treatment for Alzheimers so a diagnosis does not have clinical implications while injecting radionuclides into the brain can cause cancer or perhaps cause a stroke.
When I googled the injection this is what i found:
Letter Urging Rejection of Florbetapir F18 Injection (Amyvid)
February 21, 2011
Janet Woodcock, M.D.
Center for Drug Evaluation and Research
Food and Drug Administration
Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Dr. Woodcock:
These comments from Public Citizen Health Research Group are being submitted in response to Avid Pharmaceuticals’ New Drug Application (NDA), # 202-008, for florbetapir F18 injection (AmyvidTM), which was considered by the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee on January 20, 2011.
(1) We strongly oppose FDA approval of Avid Pharmaceuticals’ NDA for florbetapir F18 injection.
(2) Given the significant inter-reader variability that was seen in the single phase 3 clinical trial evaluating the performance of florbetapir positron emission tomographic (PET) imaging, such PET scans would have little clinical utility in the evaluation of patients presenting with cognitive deficits or early dementia and suspected of having Alzheimer’s disease (AD)....
Michael A. Carome, M.D.
Sidney M. Wolfe, M.D.
Health Research Group