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Anand Kumar, M.D.

# President

Dan Blazer, M.D., M.P.H., Ph.D.

# President-Elect

Joel Streim, M.D.

# Past President

Gary Moak, M.D.

# Secretary/Treasurer

Bruce Pollock, M.D., Ph.D.

# Secretary/Treasurer-Elect

## Members of the Board

Allan Anderson, M. D.

Peter Aupperle, M.D., M.P.H.

Karen Blank, M.D.

James Greene, M.D.

Helen Lavretsky, M.D.

Susan Lieff, M.D.

Benjamin Liptzin, M.D.

Thomas Oxman, M.D.

Kenneth M. Sakauye, M.D.

Susan Schultz, M.D.

Christine M. deVries

# Executive Director

Annual Meeting:

# March 3-6, 2005

Publications:

*American Journal of*

*Geriatric Psychiatry* and

*Geriatric Psychiatry News*

7910 Woodmont Avenue, Suite 1050, Bethesda, MD 20814-3004 Phone: (301)
654-7850 Fax: (301) 654-4137 Email: main@aagponline.org

We suggest the following specific priorities for research in this area:

HHS and its partners should create data systems that include both
Medicare (Parts A and B) and pharmacy claims data as well as those that
include both Minimum Data Set information from nursing homes and ongoing
records of medication use to support the evaluation of treatment
outcomes and surveillance for adverse effects that emerge specifically
in the elderly. Findings from these data systems could serve to guide
clinical care, and to identify specific questions of clinical, economic,
and public health importance that could only be answered by clinical
trials. These data systems and support for analyses should be made
available to investigators in academic settings as well as to those in
relevant governmental agencies.

The FDA should conduct or facilitate analyses of the safety and clinical
effectiveness of neuropsychiatric medications in the elderly from the
data that is available to it. These analyses should extend from
antipsychotic medications to the other classes of psychiatric
treatments, including antidepressants and anti-dementia medications.

HHS should establish Geriatric Neuropsychopharmacology Research Units in
academic settings to provide the infrastructure needed to conduct
clinical trials (including comparative studies as well as tests of
efficacy and effectiveness) of medications in the elderly, especially
those who are among the oldest-old, and the frail elderly. These
urgently needed units would be similar to the Research Units on
Pediatric Psychopharmacology supported by the National Institute of
Mental Health, and would collaborate with both public and private
partners to implement specific trials.

Because Medicare is now a payor for both pharmacy costs and professional
services, HHS should support comparative studies and clinical
demonstrations evaluating the extent to which disease management
strategies can improve the efficiency and value of pharmacological
treatments for the elderly. It should also support studies of the
comparative effectiveness and value of pharmacological and time limited
behavioral treatments. Recent findings from the NIMH-supported PROSPECT
study and the Hartford Foundation-supported IMPACT study demonstrate the
effectiveness of disease management strategies for major depression for
elderly primary care patients. With the changes in the scope of
Medicare, further research on these and related strategies that combine
clinical services and medications could point the way to major
improvements in the quality, value, and efficiency of care for the
elderly.

HHS and Medicare should support the NIH in extending clinical trials of
psychopharmacological treatments to the elderly. NIMH has a highly
productive program of geriatrics interventions research that has
supported the acquisition of much of the current evidence base in this
area. However, given the scope of the problem, the costs, and the risks
of treating older people with unvalidated medications tested in younger
individuals, this program is grossly under-funded.

If you should have comments or questions on this letter, please contact
Christine deVries, AAGP Executive Director, at 301-654-7850 x101;
cdevries@aagponline.org.

Thank you for your consideration of these comments.

Sincerely,

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Anand Kumar, MD

President