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Fiscal Year 2007 Budget

Director's Statement: Fiscal Year 2007 Budget Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

Fiscal Year 2007 Budget Request

Witness appearing before the

House Subcommittee on Labor-HHS-Education Appropriations

Richard J. Hodes, M.D.

National Institute on Aging

March 16, 2006

Mr. Richard J. Turman, Deputy Assistant Secretary, Budget

 Mr. Chairman and Members of the Committee:

The NIA is requesting an FY 2007 budget of $1,039,828,000, a decrease of $6,803,000, or .6 percent below the FY 2006 enacted level. 

Thank you for this opportunity to participate in today’s hearing.  I am Dr. Richard Hodes, Director of the National Institute on Aging, and I am pleased to be here today to tell you about our progress making and communicating scientific discoveries that will improve the health and well-being of older Americans.

There are today approximately 35 million Americans ages 65 and over, according to the U.S. Bureau of the Census, and this number is expected to rise dramatically in the coming decades as members of the Baby Boom generation reach retirement age.  These older Americans are more likely than at any other time in history to enjoy good health and an active lifestyle: Data from the National Long Term Care Survey (NLTCS) indicate that the rate of disability among older Americans dramatically declined from the 1980s through the mid 1990s, even among the “oldest old,” people age 85 and older.  At the same time, however, the downward trend in disability among the elderly may be in danger of reversal.  Data from the National Health Interview Survey show that, over the same period, the disability rate actually rose significantly for people ages 18-59, with the growing prevalence of obesity an important factor in this trend.  Now, in fact, some demographers are forecasting a complete leveling-off of the disability decline in the coming decade.[1]

The mission of the National Institute on Aging (NIA) is to improve the health and well-being of older Americans through research.  In support of its mission, the Institute conducts and supports an extensive program of research on all aspects of aging, from the basic cellular and molecular changes that occur as we age, to the prevention and treatment of common age-related conditions, to the behavioral and social aspects of growing older, including the demographic and economic implications of an aging society.  In addition, the NIA is the lead Federal agency for research related to the all-important effort to prevent and treat Alzheimer’s disease (AD).  Finally, our education and outreach programs provide vital information to older people across the Nation on a wide variety of topics, including living with chronic conditions, maintaining optimal health, and caregiving.

ALZHEIMER’S DISEASE AND THE NEUROSCIENCE OF AGING

Alzheimer’s disease is a devastating condition with a profound impact on individuals, families, the health care system, and society as a whole. Approximately 4.5 million Americans are currently battling AD, with annual costs for the disease estimated to exceed $100 billion.[2] Moreover, the rapid aging of the American population threatens to increase this burden significantly in the coming decades: By 2050, the number of Americans with AD could rise to some 13.2 million, an almost three-fold increase.[3]

Dr. Zerhouni has told this Committee about the NIH’s new paradigm for biomedical research that is “predictive, personalized, and preemptive.”  This vision greatly informs the NIA’s comprehensive program of Alzheimer’s disease research.  NIA-supported investigators conduct research on topics across the spectrum of AD-related inquiry, from basic brain biology to clinical trials of potential interventions.  Through these studies, we are uncovering new predictors of individual risk for AD, and using this information, along with a greater understanding of specific pathways mediating disease processes, we are developing new approaches to prevention and treatment.

Risk Factors and Early Diagnosis. Population studies suggest that conditions affecting the circulatory system may be associated with higher risk for dementia, or that the presence of vascular disease may influence the progression of AD.  One recent report indicated that AD dementia may be exacerbated by other cerebrovascular problems such as small strokes, while another linked untreated high blood pressure in mid-life with increased risk of dementia in later life.  The possible association of diabetes, insulin resistance, and AD is garnering increased attention as well; recent findings from at least four long-term studies link diabetes with decline in cognitive function.  The NIA recently funded two clinical trials to examine directly whether diabetes-related interventions might be effective in preventing or delaying cognitive decline or development of Alzheimer’s disease.

Research suggests that the earliest AD pathology begins to develop in the brain long before clinical symptoms yield a diagnosis; the ability to make an accurate early diagnosis of AD would be highly beneficial.  Improvements in brain imaging, coupled with the development of more sensitive cognitive tests, are enabling us to diagnose AD in the research setting with greater precision than ever before. Imaging techniques may become important for a number of other reasons, particularly in helping investigators understand events unfolding in specific regions of the brain in the very early stages of Alzheimer’s disease and in assessing the effectiveness of potential therapeutic strategies.  To speed both the development of imaging techniques and the discovery of biological markers to detect Alzheimer’s disease, the National Institute on Aging and other Federal partners, in conjunction with nine pharmaceutical/biotech companies, the Institute for the Study of Aging, and the Alzheimer’s Association, announced the Alzheimer’s Disease Neuroimaging Initiative in October 2004. The study will test whether serial MRI, PET, or other biological markers can be used in conjunction with clinical and neuropsychological assessment to measure earlier and with greater sensitivity the development and progression of mild cognitive impairment (MCI) and early Alzheimer’s disease. This major public-private partnership could help researchers and clinicians develop new treatments and monitor their effectiveness as well as lessen the time and cost of clinical trials. The study, which is taking place at approximately 50 sites across the U.S. and Canada, began recruitment in late 2005; approximately 800 people ages 55 to 90 will participate over the five years of the study.

Prevention and Treatment.  Results of a growing number of studies are suggesting that diet and exercise may have significant benefits on not only physical but also cognitive health.  For example, in one recent study, researchers related fruit and vegetable consumption among 13,388 older women over a 10-16 year period to subsequent cognitive performance and found that women consuming the most green leafy vegetables experienced slower decline than women consuming the least amount.  Long-term epidemiologic studies now also suggest that exercise may have a specific influence on aspects of cognitive decline, and researchers are hoping that clinical trials will be able to directly test the therapeutic value of exercise and diet for improved cognitive performance and, eventually, for reduced risk of AD.  Small clinical trials currently are ongoing to test the effects of exercise on cognitive decline, both in older adults with normal cognition and in persons with mild cognitive impairment with memory decline; a larger trial that would include a cognitive component is in the planning stages.  In addition, the planned Lifestyle Interventions and Independence for Elders (LIFE) study, which has been designed to determine whether physical exercise is effective for preventing major mobility disability or death, will include a cognitive component.  Clinical trials are also ongoing to test the effects of a variety of dietary supplements, including antioxidants and alpha-lipoic acid, on cognition.  

Investigators are also searching for drugs that will be effective in stopping the progression of AD or, ultimately, preventing the disease altogether. Recently, investigators announced the discovery of the first agent shown to delay the clinical diagnosis of Alzheimer’s in people with amnestic mild cognitive impairment, an MCI subtype strongly correlated with the later development of AD.  The investigators found that individuals who took the drug donepezil (Aricept®) were at reduced risk of progressing to a diagnosis of Alzheimer’s disease during the first year of the trial, but by the end of the three-year study there was no benefit from the drug. Although donepezil’s effects were limited, the results are nonetheless encouraging.  And although too little is known about donepezil’s long-term effects to support a recommendation for its routine use to forestall the diagnosis of AD in people with mild cognitive impairment, these findings do suggest that chemoprevention of AD is possible and support our hope that future clinical studies will lead to more significant progress.

OTHER AGING-RELATED RESEARCH

Diseases of aging continue to affect many older men and women, seriously compromising their quality of life.  Diseases and conditions currently under study at the NIA include:

Obesity. Overweight and obesity are widespread in the United States and are associated with an array of health problems, including heart disease, stroke, osteoarthritis, adult-onset diabetes, certain types of cancer and physical disability.  NIH has assigned a high priority to research on obesity.   

These activities range from basic research on the genetic and biological mechanisms of overweight and obesity to human intervention studies.  For example, recent studies of C. elegans, tiny worms frequently used for genetic studies, are providing important insights about fat regulation and storage that may that may be applicable in humans.  NIA-supported researchers used RNA interference (RNAi), a technique in which genes are inactivated one at a time to determine their function, to screen the worm’s genome and found some 417 genes involved with fat regulation and storage.  Many of the genes they found have human counterparts, a number of which had not been previously implicated in the regulation of fat storage.  The genes identified in C. elegans may ultimately suggest new targets for treating human obesity and its associated diseases.

Research has also shown that many of the disabling conditions affecting older people could be diminished through regular exercise and that fitness affects mortality risk regardless of an individual’s body fat.  One study, which followed men 30-83 years of age for an average of eight years, found that within each category of body fatness,“fit” men - as measured by exercise testing - were at a lower risk of death.  In addition, among fit men, obesity was not significantly related to risk of death.  In another study, low fitness increased mortality risk in men approximately fivefold for cardiovascular disease and threefold for all-cause mortality.  Low fitness was associated with higher mortality in all weight groups.

At a 2004 NIA and Centers for Medicare and Medicaid Services(CMS) sponsored workshop, researchers used published findings and trends to postulate that if the United States were able to prevent obesity until a person reaches 65 years of age by adjusting the[4]body mass index for all cohorts entering Medicare, we could realize a significant decline in the percent with heart disease and diabetes, a significant increase in the percent without disability, and a cost savings to Medicare on the order of $10 billion annually over the subsequent 30 years.

Heart disease.  Each year over one million Americans undergo angioplasty[5], a procedure in which a long, thin tube attached to a tiny balloon is used to access and widen a blood vessel at the site of narrowing or blockage.  However, a significant number of these individuals go on to experience restenosis, or gradual narrowing of the artery at the site of the blockage; this condition is aggravated by the implanting of stents (tiny metal scaffolds placed inside the artery to hold it open). Restenosis usually occurs within six months of angioplasty and results from the migration of cells from the middle of the arterial wall into the inner layer of the artery, where they multiply and block normal blood flow.  Recognizing that cell division is crucial to the development of restenosis, NIA scientists tested the anticancer drug paclitaxel (Taxol®), which arrests cell division, as a means of preventing the tissue growth that leads to vessel narrowing, and found that stents coated with paclitaxel can delay restenosis both safely and effectively. The investigators obtained a patent for these paclitaxel-coated stents, and a cooperative research and development agreement was established with private industry partners to begin clinical testing.  Today, paclitaxel is one of only two drugs that, when applied to stents, have been shown to safely reduce the incidence of restenosis in humans. FDA approval of paclitaxel-coated stents was granted in March 2004, and currently over 70 percent of the drug-eluting stents used worldwide are paclitaxel-coated. Approximately 1.8 million patients worldwide have received paclitaxel-coated stents to date.

Diabetes.  NIH investigators searching for potential treatments for type 2 diabetes conducted a study of the compound exendin-4, an analog of a hormone that is naturally released after eating and that can lower blood sugar in people with diabetes. The investigators found that exendin-4 is safe and effective, and in April 2004, the Food and Drug Administration approved exenatide (ByettaTM), a synthetic derivation of exendin-4, for the treatment of type 2 diabetes.

HEALTH COMMUNICATIONS AND PROMOTION

The NIHSeniorHealth website continues to be a major initiative that enables the growing number of “wired seniors” to find credible aging-related health information in an online format that is compatible with their cognitive and visual needs, as evidenced by NIH-supported research.  Conceived by NIA and jointly developed with the National Library of Medicine (NLM), the website now includes 26 health topics developed by eleven NIH Institutes.  Each month, 52,000 unique visitors browse over a half a million pages.  NIHSeniorHealth serves as a model for web designers seeking to make sites accessible to older adults.  To increase the number of older adults skilled in searching for health information online, NIA has developed and is evaluating a senior-friendly Internet training curriculum geared around NIHSeniorHealth and NLM’s MedlinePlus web site for those who train older individuals to use computers.

Changes in public health policy may necessitate the development of new communications strategies and techniques targeted at older Americans, as was demonstrated with the passage of Medicare Part D, the “prescription drug benefit” for U.S. seniors.  NIA-supported researchers are currently using established datasets to rapidly collect information and analyze patterns of use under Medicare Part D; their findings have been communicated to the CMS on an ongoing basis and will inform the creation of new strategies for tailored communications that will assist older Americans in understanding and maximizing use of this important new program.

Thank you for the opportunity to testify before this Subcommittee.  I would be happy to answer any questions you may have.

[1]Goldman DP et al.  Consequences of Health Trends and Medical Innovations for the Future Elderly.  Health Affairs online special issue “Health and Spending of the Future Elderly.”  R5-R17, 2005.

[2]Data from the Alzheimer’s Association.  See also Ernst, RL; Hay, JW. “The U.S. Economic and Social Costs of Alzheimer’s Disease Revisited.” American Journal of Public Health 1994; 84(8): 1261 – 1264. This study cites figures based on 1991 data, which were updated in the journal’s press release to 1994 figures.

[3]Hebert, LE et al. “Alzheimer Disease in the U.S. Population: Prevalence Estimates Using the 2000 Census.” Archives of Neurology August 2003; 60 (8): 1119 – 1122.

[4]Lakdawalla, DN et al. The Health and Cost Consequences of Obesity Among the Future Elderly.  Health Affairs online special issue “Health and Spending of the Future Elderly.”  R30-41.

[5]Data from the National Heart, Lung, and Blood Institute.