June 30, 2003
April 30, 2001
Ms. Jane Axelrad, J.D.
Associate Director of Policy
Center for Drugs Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Ms. Axelrad:
On behalf of the Society of Nuclear Medicine, I would like to offer our strong support for the addition of Alzheimer's disease as an FDA approved (and ultimately HCFA reimbursable) indication for a FDG-PET (positron emission tomography) scan.
As you know, the standard wisdom is that there is no definitive way to diagnosis Alzheimer's disease other than autopsy. The information compiled by Dr. Jorge Barrio, from studies all over the United States strongly supports the value of PET as a diagnostic tool for this devastating condition. There are a number of compelling reasons PET is a valuable tool for physicians-and for families trying to learn whether the memory lapses and difficult behaviors of their loved ones are due to Alzheimer's or to some other disease.
Right now more than 19 million Americans are estimated to be caring for someone with Alzheimer's disease-and home care for a person whose disease has progressed is estimated to cost about $47,000 per year. By the middle of this century, as many as 14 million of today's baby boomers could have Alzheimer's disease. Providing families and physicians with the tool that can help keep those with the disease functioning independently would seem a most cost-effective approach to care.
We urge you agree with the many researchers whose work is outlined in Dr. Barrio's materials, and add Alzheimer's disease to the list of FDA approved and reimbursable indications for PET.
Jonathan Links, PhD
Society of Nuclear Medicine