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VA RESEARCH ON ALZHEIMER’S DISEASE,

PARKINSON’S DISEASE, AND DIABETES

HEARING

BEFORE THE

SUBCOMMITTEE OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON VETERANS’ AFFAIRS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

APRIL 28, 2004

Printed for the use of the Committee on Veterans’ Affairs

Serial No. 108–38

(
COMMITTEE ON VETERANS’ AFFAIRS 

CHRISTOPHER H. SMITH, New Jersey, Chairman 

MICHAEL BILIRAKIS, Florida 

TERRY EVERETT, Alabama 

STEVE BUYER, Indiana 

JACK QUINN, New York 

CLIFF STEARNS, Florida 

JERRY MORAN, Kansas 

RICHARD H. BAKER, Louisiana 

ROB SIMMONS, Connecticut 

HENRY E. BROWN, JR., South Carolina 

JEFF MILLER, Florida 

JOHN BOOZMAN, Arkansas 

JEB BRADLEY, New Hampshire 

BOB BEAUPREZ, Colorado 

GINNY BROWN-WAITE, Florida 

RICK RENZI, Arizona 

TIM MURPHY, Pennsylvania 

LANE EVANS, Illinois 

BOB FILNER, California 

LUIS V. GUTIERREZ, Illinois 

CORRINE BROWN, Florida 

VIC SNYDER, Arkansas 

CIRO D. RODRIGUEZ, Texas 

MICHAEL H. MICHAUD, Maine 

DARLENE HOOLEY, Oregon 

TED STRICKLAND, Ohio 

SHELLEY BERKLEY, Nevada 

TOM UDALL, New Mexico 

SUSAN A. DAVIS, California 

TIM RYAN, Ohio

PATRICK E. RYAN, Chief Counsel and Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

STEPHEN E. BUYER, Indiana, Chairman 

MICHAEL BILIRAKIS, Florida 

TERRY EVERETT, Alabama 

JOHN BOOZMAN, Arkansas 

DARLENE HOOLEY, Oregon 

LANE EVANS, Illinois 

BOB FILNER, California 

TOM UDALL, New Mexico

(II) 
(III)

C O N T E N T S 

April 28, 2004

Page

VA Research on Alzheimer’s Disease, Parkinson’s Disease, and Diabetes ......... 1

Chairman Buyer ...................................................................................................... 1

Hon. Darlene Hooley ............................................................................................... 3

Hon. Tom Udall ....................................................................................................... 4

Hon. Lane Evans ..................................................................................................... 4

WITNESSES 

Ferrante, Robert J., Director, Experimental Neuropathology Program, Geriatric Research, Education and Clinical Center, Bedford VA Medical Center, 

Department of Veterans Affairs .......................................................................... 13

Prepared statement of Dr. Ferrante ............................................................... 58

Kussman, Michael J., M.D., Acting Deputy Under Secretary for Health, Veterans Health Administration, Department of Veterans Affairs, accompanied 

by Timothy J. O’Leary, M.D., Director, Biomedical Laboratory R&D Services, Office of Chief Research and Development Officer, Veterans Health 

Administration, Department of Veterans Affairs .............................................. 9

Prepared statement of Dr. Kussman .............................................................. 46

Salerno, M.D., Judith A., Deputy Director, National Institute on Aging, National Institutes of Health, accompanied by Diane D. Murphy, Program 

Director, Neurodegeneration, National Institute on Neurological Disorders 

and Stroke, National Institutes of Health; Judith Fradkin, M.D., Director, 

Division of Diabetes, Endocrinology and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes 

of Health; Marcelle Morrison-Bogorad, Associate Director, Neuroscience and 

Neuropsychology of Aging Program, National Institute on Aging, National 

Institutes of Health .............................................................................................. 6

Prepared statement of Dr. Salerno ................................................................. 33

Sano, Mary, Associate Chief of Staff for Research, Bronx VA Medical Center, 

Department of Veterans Affairs .......................................................................... 14

Prepared statement of Dr. Sano ...................................................................... 61

Zieve, Franklin J., M.D., Associate Chief of Staff for Research, Richmond 

VA Medical Center, Department of Veterans Affairs ....................................... 11

Prepared statement of Dr. Zieve ..................................................................... 55

MATERIAL SUBMITTED FOR THE RECORD 

Statement: 

Kathleen A. Gold, RN, MSN, CDE, Diabetes Research and Wellness 

Foundation ..................................................................................................... 65

Written committee questions and their responses: 

Chairman Buyer to National Institute of Aging ............................................ 77

Chairman Buyer to National Institute of Health .......................................... 80

Chairman Buyer to Department of Veterans Affairs .................................... 82

Chairman Buyer to Dr. Kussman ................................................................... 89

(1)

VA RESEARCH ON ALZHEIMER’S DISEASE, 

PARKINSON’S DISEASE, AND DIABETES 

WEDNESDAY, APRIL 28, 2004

U.S. HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON VETERANS’ AFFAIRS, Washington, DC 

The subcommittee met, pursuant to notice, at 10 a.m., in room 

334, Cannon House Office Building, Hon. Steve Buyer (chairman of 

the subcommittee) presiding. 

Present: Representatives Buyer, Hooley, Evans, Boozman, and 

Udall. 

OPENING STATEMENT OF CHAIRMAN BUYER 

Mr. BUYER. Good morning. 

The Subcommittee on Oversight and Investigations of the Committee on Veterans’ Affairs will come to order. 

Today’s VA hearing of this subcommittee will focus on the VA research on Alzheimer’s disease, Parkinson’s disease, and diabetes. 

The date is April 28, 2004. 

By way of opening, I would like to commend the President. 

Yesterday he was in Baltimore, and his proposal to provide 100 

million in IT grants is welcomed. It is an important step in advancing the electronic medical records. Electronic medical records will 

increase patient safety, provide cost savings, and ensure greater efficiencies. 

This subcommittee has held numerous hearings on this issue, 

and I believe that the VA can be at the forefront of leading our 

medical industries with IT and how we can best serve patients in 

this country. 

I have not had the opportunity to read the President’s executive 

order that he signed in its entirety here. I look forward to reading 

it after the hearing. The executive order regards the incentives for 

the use of information technology in establishing a position of the 

National Health Information Technology Coordinator, and this is a 

very, very good initiative, and the President not only looking to the 

VA but then turning to Health and Human Services to begin to 

move the country to the forefront and utilize technologies. 

This is a good thing. 

Today’s hearing will review biomedical research being conducted 

by the VA and the NIH on Alzheimer’s disease, Parkinson’s disease, and diabetes. It will also provide us with an opportunity to 

learn about collaborative efforts between the VA and NIH in these 

fields of research. 
2

I think most of us have the same questions when the subject of 

Alzheimer’s, diabetes, and Parkinson’s is brought up. I believe we 

would all like to know what are the root causes of these diseases, 

what are the risk factors in developing these diseases, and what 

treatments are available. 

Many of us in this room have family members or know friends 

or neighbors or colleagues afflicted by these life-changing diseases. 

The VA and NIH have been making tremendous strides in these 

areas. For instance, several generic markers have been identified 

for Alzheimer’s, but the cause of the disease is still unknown. 

Alzheimer’s may be genetic in nature. In fact, three major genes 

for early onset AD and one of the major risk factors genes of late 

onset AD have been identified. 

Other possible links include elevated levels of certain amino 

acids called homocysteine, and inflammation in the brain. 

In the case of Parkinson’s disease, many researchers believe that 

the combination of oxidative damage, environmental toxins, genetic 

predispositions, and accelerated aging are responsible for the development of this disease. 

Researchers are still searching for the cause or causes of diabetes. While Type 1 diabetes usually occurs in childhood and adolescence, it is also found in adults. Type 2 diabetes, usually associated 

with older, overweight individuals, is now also manifesting itself in 

young adults and children. 

Treatment of Type 1 diabetes is through daily insulin injections. 

Type 2 diabetes is usually monitored and treated through diet and 

exercise and in some case with a combination of diet, exercise, and 

medication. 

Approximately 4.5 million Americans are estimated to have Alzheimer’s, and the VA treated approximately 103,800 veterans with 

Alzheimer’s in 2003. Alarmingly, the number of people with Alzheimer’s is projected to rise to 7 million by 2020 and 14 million by 

2050. 

Thenational cost of Alzheimer’s disease is estimated to be in excess of $100 billion. AD is the eighth leading cause of death in the 

United States, 53,852 in 2001, the latest statistics that were available from CDC. 

Diabetes affects more than 18 million and is the sixth leading 

cause of death, in excess of 200,000 individuals per year. The 

estimatednational cost of diabetes to our society is $132 billion a 

year. 

Parkinson’s disease strikes about 50,000 people a year. The total 

number of people afflicted with Parkinson’s is estimated to be between 500,000 to 1 million. It is estimated that 42,000 veterans 

suffer from Parkinson’s. The cost to the Nation is estimated in excess of $5.6 billion annually. 

At the present time, there is no cure for any of these diseases. 

Treatment is also limited, and many of the medications given to alleviate the symptoms often have serious side effects. 

I look forward to hearing from our witnesses about the research 

being conducted by the departments and any new developments in 

these specific areas of research. 

One of the areas that I am most hopeful to hear from the witnesses is that the Congress is beginning to be more focused on pre-
3

vention rather than treatment on the back end. So, I am most 

hopeful that we can have part of that discussion here today. 

At this time, I will yield to the ranking member for any comments she may have. 

Ms. Hooley, you are now recognized. 

OPENING STATEMENT OF HON. DARLENE HOOLEY 

Ms. HOOLEY. Thank you, Mr. Chair. 

I am pleased that this subcommittee will hear testimony today 

regarding the progress of treating Parkinson’s, Alzheimer’s, and diabetes. As our chairman said, I think we all know family and 

friends that have been diagnosed with one of these diseases, and 

I know my mother, who died of cancer, the disease she was most 

afraid of was Alzheimer’s. 

Our witnesses represent some of the brightest leaders in research on this subject of anywhere in the world. So I am very excited to hear what you have to say today. Thank you for being here 

and informing this subcommittee of both your progress and your 

prognosis for the future regarding these diseases. 

I understand that some collaborative research involves VA medical centers and utilizes staff facilities and patients from the Department of Veterans Affairs. I also understand that these collaborative efforts have yielded state-of-the-art treatments, treatments 

that may substantially reduce the potential devastating impact of 

these debilitating diseases. 

My home state of Oregon is host to a collaborative research effort 

involving the Oregon Health Science University and the Portland 

VA Center and other institutions to create a Center of Excellence 

in Oregon to improve care for people with Parkinson’s disease. The 

Parkinson’s Center of Oregon is anationally recognized leader in a 

broad spectrum of research on Parkinson’s and related neurological 

disorders. 

The Oregon Center and other Parkinson’s centers of excellence 

investigate the effects of various treatment methods involving 

medication, mobility, exercise, training, and surgery-based solutions that provide deep brain stimulation. 

Diabetes is characterized in witness statements as a major and 

escalating public health problem affecting some 18 million Americans. It is a problem with cost—financial cost, human cost. One in 

every six veterans has diabetes. Its prevalence in the general population is growing at an alarming rate. In two decades, one-tenth of 

our population will be afflicted. 

VA must be ready for increasing numbers of patients with the 

disease in the out-years, anticipating that those patients will place 

an increased burden on our resources. 

Beyond necessitating lifestyle change in those who are afflicted, 

the disease carries with it an increased risk of coronary artery disease and stroke, as well as microvascular complications that may 

result in blindness or amputation. 

Alzheimer’s disease is also growing in prevalence in the United 

States general population as it gains longevity. Alzheimer’s begins 

with mild memory loss and progresses until even simple tasks cannot be performed. Alzheimer’s changes the wiring in the brain 
4

through an inexorable buildup of plaques and tangles which result 

in the loss of connections among nerve cells involved with memory. 

Currently, about 4.5 million people have Alzheimer’s. Forecasts 

paint a bleak future if remedies are not found. 

Research has yielded an increased understanding of disease 

mechanisms for each topic area at today’s hearings. I look forward 

to hearing what’s been accomplished in each area and what the future holds. 

Thank you, and I yield back. 

Mr. BUYER. Mr. Udall, would you like an opening statement? 

Mr. UDALL. Yes. Thank you, Mr. Chairman. 

Mr. BUYER. You are now recognized. 

OPENING STATEMENT OF HON. TOM UDALL 

Mr. UDALL. I would like to thank the chairman and ranking 

member for holding a hearing on this important topics. 

Alzheimer’s, Parkinson’s, and diabetes strike a very personal 

chord for millions of Americans, including me. My uncle, Morris 

Udall, affectionately known by many members of Congress as ‘‘Mo,’’ was diagnosed with Parkinson’s disease in 1979, after serving as 

a member of the House of Representatives for 18 years. Even after 

his diagnosis, he remained an active Member of Congress until 

1991. 

In 1997, the President signed a bill called the Morris K. Udall 

Parkinson’s Disease Research Act, which helped establish 11 Udall 

Centers of Excellence for Parkinson’s disease research at medical 

institutions around the country. These centers conduct research in 

an effort to improve diagnosis and treatment of those with Parkinson’s and other neurodegenerative disorders. 

I have seen firsthand the devastating effects of this disease. I 

know the hardships it causes for 50,000 Americans who are diagnosed with Parkinson’s each year. The approximately 42,000 veterans who suffer from Parkinson’s need to know that NIH and the 

VA are doing—what they are doing to research this condition and 

to work towards a cure. 

I look forward to hearing from our panelists on this topic. I also 

look forward to hearing from our panelists about efforts to combat 

Type 2 diabetes in veterans and in the general population. 

The figures showing how much this disease costs the Nation each 

year, approximately 132 billion, are startling. Educating our Nation on preventive health measures and helping those who are 

most at risk of this disease is critical on many levels. 

I think we all agree that health care for our Nation’s veterans 

should be the best of the best. This hearing presents the perfect opportunity to flesh out how this goal is being accomplished through 

the NIH and the VA and the collaboration between them, and I 

thank you, Mr. Chairman, and yield back. 

Mr. BUYER. Ranking member of the full committee for an opening statement, Mr. Evans, you are now recognized. 

OPENING STATEMENT OF HON. LANE EVANS 

Mr. EVANS. Thank you, Mr. Chairman. 

I, along with 500,000 of my fellow Americans, live with Parkinson’s every day. I personally understand the challenge of physical 
5

activities that once were second nature. I used to play basketball 

in the old days. 

I commend the VA’s initiation and implementation of six specialized research areas. VA has partnered with these agencies to create 

centers of excellence for Parkinson’s and many other diseases, as 

well. 

As the veteran population gets older, it is important the VA target the age-specific issues we have before us today. Research holds 

the promise that a cure exists for victims of those diseases and that 

a cure is just over the horizon. 

I will vouch for the fact that there are significant quality of life 

issues at stake in achieving a cure. 

Mr. Chairman, again, I appreciate your holding this hearing and 

look forward to working with you on these issues and others in the 

near future. 

Thank you very much. 

Mr. BUYER. Thank you, Mr. Evans. You are a living reminder 

and example to a lot of us of having to go through Parkinson’s, and 

no differently than Mr. Udall’s uncle, who ended up here in a VA 

hospital and was well cared for here in Washington, DC. 

We are really proud of you, Lane, because your mind is as sharp 

as it was on the basketball court and as it was as a United States 

Marine, but the body is not keeping up, and the more we are able 

to learn about the human physiology and the body, it is extremely 

important. We are proud of you for sustaining yourself in an institution that can be very difficult and highly dynamic. You are a 

good reminder to a lot of us that our bad day is really one of your 

good days, and I am proud of you for that. I am glad you are here 

today, and you will be an excellent participant in this hearing 

today. 

Dr. Salerno, I am going to open up by saying I am also very 

proud of you. 

Anybody that can go through Harvard and then take on a commission and serve as a lieutenant commander—you are a mentor 

to many Harvard graduates, some of whom I know, and I will yield 

to you first—only Dr. Kussman, because she pulls rank on you, too, 

but please, Dr. Salerno, you are now recognized for an opening 

statement. 

If you have a written statement, it shall be entered into the 

record. 

You are now recognized for five minutes. 
6

STATEMENTS OF JUDITH A. SALERNO, M.D., DEPUTY DIRECTOR, NATIONAL INSTITUTE ON AGING, NATIONAL 

INSTITUTES OF HEALTH, ACCOMPANIED BY DIANE D. MURPHY, PROGRAM DIRECTOR, NEURODEGENERATION, NATIONAL INSTITUTE ON NEUROLOGICAL DISORDERS AND 

STROKE, NATIONAL INSTITUTES OF HEALTH; JUDITH 

FRADKIN, M.D., DIRECTOR, DIVISION OF DIABETES, ENDOCRINOLOGY AND METABOLIC DISEASES, NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES, 

NATIONAL INSTITUTES OF HEALTH; MARCELLE MORRISONBOGORAD, ASSOCIATE DIRECTOR, NEUROSCIENCE AND 

NEUROPSYCHOLOGY OF AGING PROGRAM, NATIONAL INSTITUTE ON AGING, NATIONAL INSTITUTES OF HEALTH; MICHAEL J. KUSSMAN, M.D., ACTING DEPUTY UNDER SECRETARY FOR HEALTH, VETERANS HEALTH ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED 

BY TIMOTHY J. O’LEARY, M.D., DIRECTOR, BIOMEDICAL LABORATORY R&D SERVICES, OFFICE OF CHIEF RESEARCH AND 

DEVELOPMENT OFFICER, VETERANS HEALTH ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS; FRANKLIN J. 

ZIEVE, M.D., ASSOCIATE CHIEF OF STAFF FOR RESEARCH, 

RICHMOND VA MEDICAL CENTER, DEPARTMENT OF VETERANS AFFAIRS; ROBERT J. FERRANTE, DIRECTOR, EXPERIMENTAL NEUROPATHOLOGY PROGRAM, GERIATRIC RESEARCH, EDUCATION AND CLINICAL CENTER, BEDFORD VA 

MEDICAL CENTER, DEPARTMENT OF VETERANS AFFAIRS; 

AND MARY SANO, ASSOCIATE CHIEF OF STAFF FOR RESEARCH, BRONX VA MEDICAL CENTER, DEPARTMENT OF 

VETERANS AFFAIRS 

STATEMENT OF JUDITH A. SALERNO 

Dr. SALERNO. Thank you. 

Thank you, Chairman Buyer. 

I am pleased to be here today to discuss three conditions of great 

importance to the health and well-being of millions of Americans—

Alzheimer’s disease, Parkinson’s disease, and diabetes. 

I am deputy director of the National Institute on Aging, the lead 

Federal agency for Alzheimer’s research. I’m accompanied by my 

colleagues today, Dr. Diane Murphy of the National Institute of 

Neurologic Disorders and Stroke; Dr. Judith Fradkin of the National Institute of Diabetes and Digestive and Kidney Diseases; 

and my NIA colleague, Dr. Marcelle Morrison-Bogorad. 

With the rising number of older Americans, the prevention and 

treatment of these diseases has become an urgent public health 

priority, because these diseases disproportionately affect the older 

population. Nowhere is this more important than in the veteran 

population, where 37 percent are elderly, compared to 13 percent 

of the total U.S. population. 

It is our hope that ournational investment in research will result 

in dramatic gains in our ability to understand, diagnose, treat, and 

ultimately prevent these devastating diseases. 

Our efforts have been greatly enhanced through the involvement 

of veterans who participate in our research studies and the collaboration of many research scientists in VA. 
7

Alzheimer’s is a progressive neurodegenerative disorder that 

starts with mild memory loss but is relentlessly progressive until 

it destroys all cognitive function. About 4.5 million Americans, as 

you have heard, currently have AD at a cost of about $100 billion 

a year. 

While National Institute of Health’s Alzheimer’s research program is quite broad, I’d like to highlight one area of our portfolio, 

the identification of those at highest risk for developing the disease, so that we can target early interventions. 

In the past decade, we have identified three major gene 

mutations, as you also have heard, and I might add that one of 

these was identified by a VA investigator who was jointly funded 

by the NIH, and these genes were associated with the early onset 

form of the disease, and we have also found another gene, ApoE4, 

which is a major risk factor for the more common late onset form, 

and scientists have recently uncovered a set of genes that may influence not whether but when a person develops Alzheimer’s. 

In addition to age, epidemiologic studies have identified heart 

disease, high blood pressure, stroke, and Type 2 diabetes as risk 

factors for Alzheimer’s, and through research using powerful imaging techniques such as positron emission tomography and magnetic 

resenance imaging or MRI’s, we are opening new windows into the 

living brain as we move toward more sensitive and accurate tools 

for the early diagnosis of Alzheimer’s. 

I would like to also mention that we are currently supporting 25 

Alzheimer’s prevention and treatment trials, a number of which 

are conducted at VA medical centers, yet another way that our 

partnership has strengthened AD research. 

I would like to turn now to Parkinson’s disease, another debilitating neurologic disorder. 

The loss of nerve cells that control movement and that produce 

the neurotransmitter dopamine leads to tremors, rigidity, and slowing of movement along with other symptoms. This affects about 

500,000 Americans. 

Many patients can be treated successfully with the drug L-dopa, 

but for some, the effect might not be long-lasting. 

However, research has led to new opportunities for the improved 

treatment of Parkinson’s patients. In the year 2000, the NIH developed a five-year plan, the Parkinson’s disease research agenda, to 

capitalize on these emerging opportunities. 

In mid–2002, in the second phase of this plan, a summit of outstanding scientists in the field was convened, and their meeting resulted in the development of a matrix which outlined short to longrange and low-risk to high-risk goals that address ways we can get 

around the road blocks to progress in Parkinson’s research. 

Clinical testing of promising treatments is a high priority at 

NIH. 

As part of this effort, the NINDS has developed the neuro-protection exploratory trial, or NET-PD, which is expediting the selection 

and then testing compounds through use of a network of clinical 

sites around the country, and a collaboration of VA and NIH has 

led to the largest trial of surgical therapy to date, a study of deep 

brain stimulation with implanted electrodes. 
8

Additionally, ongoing testing of gene therapy strategies and animal models of Parkinson’s disease will guide us on the path toward 

new opportunities in human gene therapy. 

The third condition I’ve been asked to discuss, diabetes, is an escalating public health problem in the U.S., sixth leading cause of 

death. 

It lowers life expectancy up to 15 years and leads to kidney failure, lower limb amputations, blindness, and heart disease. 

As you also have heard, 6 percent of the population, or some 18.2 

million Americans, have diabetes. Ninety to 95 percent of those 

have Type 2, what was formerly known as adult onset diabetes, 

and nearly one-third of those with diabetes are unaware that they 

have the disease and therefore are not taking the steps proven effective in reducing its complications. 

Prevention is the key to controlling the diabetes epidemic. The 

recently published results of the NIH’s Diabetes Prevention Program showed that sedentary, overweight individuals at risk for diabetes including older individuals participating in the study could 

prevent or delay the disease onset through lifestyle interventions. 

The NIDDK and the Centers for Disease Control are actively 

supporting translation of these important results into real health 

gains. They have recently launched the firstnational diabetes prevention program, Small Steps, Big Rewards. Its message is that, 

through moderate weight loss, 5 to 7 percent of body weight, 30 

minutes of physical activity five days a week, and a healthy diet, 

diabetes can be prevented of delayed. 

The NIH also coordinates the Diabetes Mellitus I inter-agency 

Coordinating Committee, which harmonizes diabetes activities 

across all Federal agencies. As an example of our collaboration, 

NIDDK and VA have jointly funded research on specialized footwear to prevent diabetic foot ulcers. Both agencies are also working 

together on thenational diabetes quality improvement alliance to 

improve adult diabetes care. 

As our population rapidly ages, it is important that we continue 

to work with our Federal partners to find ways to effectively address these diseases that are associated with advanced age. 

While we are making great strides, much work remains so that 

we can fulfill the promise of healthy old age for our veterans and 

for all Americans. 

It is difficult to do justice in five minutes to all the exciting research that is occurring with Federal support, but I hope that I 

have conveyed to you some of the great excitement and hope with 

which we view our work. 

I would be happy to take questions, as would my colleagues. 

Thank you. 

Prepared statement of Dr. Salerno appears on p. 33.] 

Mr. BUYER. Dr. Salerno, will you please introduce the staff that 

you brought with you by their name and title, and please have 

them stand. 

Dr. SALERNO. Dr. Diane Murphy from NINDS, who is our expert 

in Parkinson’s disease; Dr. Judith Fradkin from NIDDK—who is 

our expert in diabetes; and Dr. Marcelle Morrison-Bogorad, who 

runs the NIA research program in Alzheimer’s disease. 
9

Mr. BUYER. All three are here and prepared to answer any questions that any of the subcommittee members may have? 

Dr. SALERNO. Yes. 

Mr. BUYER. Great. Thank you very much. 

Dr. Kussman, those of us who control the ground and move the 

caissons, along with our comrades, the Marines, generals, I appreciate your opportunity to throw a bone to the lieutenant commander of the Navy. You have got to do that every once in a while. 

So, sir, you are now recognized for five minutes. 

STATEMENT OF MICHAEL J. KUSSMAN 

Dr. KUSSMAN. Well, good morning, Sir. Good morning, Mr. Chairman and Members of the committee. I had no problem of your pulling rank, Sir. 

I appreciate this opportunity to appear before you to discuss VA 

research into Alzheimer’s disease, diabetes, and Parkinson’s disease. 

VA research is committed to better understanding the causes and 

developing treatments and preventive measures for these diseases. 

With me today, besides the other distinguished witnesses here at 

the table, is Dr. Timothy J. O’Leary, Director of the VA’s Biomedical Laboratory Research and Development Services. 

Parkinson’s disease is a slowly progressive disorder that results 

from the degeneration of nerve cells in a small area of the 

midbrain. 

The prevalence of the disease, which afflicts over 500,000 Americans, increases with age. It affects 1 percent of the U.S. population 

over age 60 and 3.4 percent over age 74. 

VA medical centers treat over 40,000 Parkinson’s disease patients every year. 

Over the past five years, VA funding for Parkinson’s disease research has nearly doubled, with $10.1 million allocated for projects 

in fiscal year 2004. Since fiscal year 1999, non-VA funding has 

more than doubled. 

Funded projects focus on various aspects of research, including 

the role of neurotransmitters, advances in neuro imaging technologies, gene therapy and animal models, mechanisms of damage 

to nerve cells, non-motor aspects of Parkinson’s disease, rehabilitative strategies, and clinical trials of surgical treatment. 

With the development of six Parkinson’s Disease Research, Education, and Clinical Centers, or PADRECCs, VA took a major step 

toward improving patient care and outcomes while, over the longer 

term, pursuing a cure for Parkinson’s disease. 

Operating as anational consortium, the PADRECCs conduct research covering basic biomedicine, rehabilitation, health services 

delivery, and clinical trials. 

They are also implementing a prospective patient care registry as 

a means of monitoring the care of veterans. The anticipated benefits are the improvement of clinical care by tracking the clinical 

status and interventions of veterans with Parkinson’s disease. 

Diabetes is a leading cause of disability and death in the United 

States. Complications include blindness, end stage renal disease, 

and amputation. Middle-age persons with diabetes have two to four 
10

times the risk of coronary artery disease and stroke as do similar 

persons without diabetes. 

Approximately 18 million people have diabetes mellitus, and 

each year, over one million more people over the age of 20 develop 

the disease. 

Diabetes affects nearly 20 percent of veterans receiving care in 

the VA health care system, and veterans with diabetes account for 

nearly 25 percent of all pharmacy costs and for more than 1.7 million hospital days of care annually. 

Over the past five years, VA funding for diabetes research has 

increased to over $16.8 million in fiscal year 2004. Since fiscal year 

1999, non-VA funding has grown by more than $13 million. 

Some of the areas of research include diabetes-related complications in aging and effects of exercise and diet, regulation of glucose 

transporters and gene transcription by insulin and glucose, pathogenesis and genetics of diabetic neuropathy and diabetic retinopathy, linkage analysis and genetic studies of type 2 diabetes, and 

rehabilitative strategies. 

We have seen great improvements in the quality of care and 

health outcomes of veterans with diabetes as a result of the VA’s 

Diabetes Mellitus Quality Enhancement Research Initiative. 

This initiative will help identify and evaluate diabetes care practices, current gaps in care, and interventions to improve patient 

care outcomes. 

It will facilitate the implementation of interventions and care 

processes that are most likely to produce substantial improvements 

in the quality and length of life for many veterans with diabetes. 

Alzheimer’s disease is a complex illness that causes the gradual 

loss of brain cells. It is the leading cause of dementia. Nearly 4.5 

million Americans have this disease. It is a major cause of morbidity and mortality among veterans. 

VA supports a broad array of studies on Alzheimer’s disease. 

Over the past five years, VA funding for Alzheimer’s disease research has increased to over $6.3 million in fiscal year 2004. Since 

fiscal year 1999, non-VA funding has increased by over $12 million. 

Some of the areas of research include vaccine development, advances in neuroimaging technologies, gene therapy in animal models, mechanisms of damage to nerve cells, inflammatory mechanisms, gene-environment interactions, and therapeutic interventions. 

VA has recently funded several significant studies on the quality 

of care and outcomes of veterans with Alzheimer’s disease. 

Investigators have demonstrated that veterans with dementia 

who receive appropriate interventions from care givers might be 

able to remain at home longer in environments that promote maximum independence for both caregivers and patients. 

Researchers have also revealed a significant relationship between 

discomfort and agitation among nursing home residents with dementia, suggesting that agitated behaviors may be associated with 

increased pain. Accordingly, better quality of life for long-term care 

residents may result from regularly scheduled pain management. 

We are very proud of the VA’s accomplishments in Parkinson’s 

disease, diabetes, and Alzheimer’s disease research, and we remain 
11

committed to maintaining the highest quality research in the country to best serve the needs of our Nation’s veterans. 

Mr. Chairman, this concludes my opening statement. My formal 

statement has been submitted for the record. 

Dr. O’Leary and I will now be happy to answer any questions 

that you might and other members of the subcommittee might 

have. 

Thank you. 

Prepared statement of Dr. Kussman appears on p. 46.] 

Mr. BUYER. Thank you, Dr. Kussman. 

I now recognize Dr. Franklin Zieve, the Associate Chief of Staff 

for Research, Richmond VA Medical Center. 

STATEMENT OF FRANKLIN ZIEVE 

Dr. ZIEVE. Thank you, Mr. Chairman. 

I speak to you today in a dual role. For 27 years, I have been 

associate chief of staff for research at Richmond, and I also am director of our diabetes health center. I am going to confine my remarks strictly to what is going on in Richmond, but I think virtually every VA medical center would have a comparable story. 

I am not going to tell you that diabetes is getting more common, 

because you have already heard that three times, but I can give 

you a quick reason as to why: a year from now, all of us will be 

one year older and, on the average, will weigh a pound-and-a-half 

more than we do today, and a larger fraction of us will have diabetes. 

Well over half of the heart attacks in this country occur in people 

who have either diabetes or its precursor, which is variously known 

as pre-diabetes or the metabolic syndrome, and most heart attacks, 

like all other complications of diabetes, are preventable. The problem with Type 2 diabetes is that there are so many of them that 

technically doing the prevention becomes very difficult. Any of us 

could give great care to 50 diabetics, but we have 6,000 of them in 

Richmond alone. 

The main reason I am still in the VA after 33 years of Federal 

service is that I feel that VA is a uniquely favorable place for giving good diabetes care. One of our advantages you mentioned, Mr. 

Chairman, in your initial statement, our computerized patient 

record, which is just a tremendous advantage which enables us to 

see when we are doing things poorly, and the biggest advantage we 

have is the veterans themselves, who I think are uniquely rewarding and good patient population to work with. 

I would like to address how research fits into our clinical operation. The VA research program covers a wide spectrum of studies 

ranging from cloning genes to how you structure the delivery of 

care, but all of these have in common that they are patient-focused. 

The most basic VA projects grow out of what we see clinically 

every day. For example, the fundamental driver of the increased 

prevalence of diabetes is our society’s epidemic of obesity, and my 

colleague, Dr. Jim Levy, runs our weight management program 

and finds, as does every weight management program, that getting 

people to lose weight is easy. The problem is they regain it promptly, and this led him to study the regulation of leptin, which is the 

hormone from adipose tissue which regulates both appetite and en-
12

ergy expenditure, and his studies in rodents have produced some 

unexpected findings. 

For example, he found when rats were fed omega-3 fatty acids 

in the form of fish oil, they tremendously increased their energy expenditure. I do not know how many of us would have thought of 

feeding fish oil to rats—rats, incidentally, love fish oil; they just lap 

it up—but the idea came from some patients with the metabolic 

syndrome who we treated with fish oil for their high plasma 

triglycerides and unexpectedly found that their fatty livers went 

away. 

So this is an example of basic research flowing directly from clinical care. 

Dr. Kussman mentioned the VA diabetes trial in which we are 

a site, and I will not talk about it further other than to point that 

however this turns out, it is going to establish an international 

standard of care on a rather important issue. 

I will talk briefly about our research that addresses therapies 

that we know work but that are hard to apply in clinical practice. 

For example, I mentioned that well over half the heart attacks in 

this country happen to people who have either the metabolic syndrome or diabetes. 

Most of these could be prevented if everything that we know 

works were implemented maximally—lifestyle changes, cholesterol 

and triglyceride lowering, blood pressure control, aspirin, beta 

blockers, ACE inhibitors, you name it. The problem is how to apply 

these effective therapies to the large numbers of patients who 

would benefit from them. 

So our current health care delivery research at Richmond involves a pilot metabolic syndrome clinic in which a group of these 

veterans who have such high heart attack risk has six monthly visits in which we gang tackle their cardiac risk factors. 

Five hundred veterans have completed the full sequence as of 

last week. 

One of our patients referred to this program as boot camp, but 

all of us have been very impressed with its effectiveness. Over 70 

percent of the patients have achieved their very stringent lipid and 

blood pressure goals. 

Everything we do in this clinic has long been known to reduce 

coronary risk, but in the country as a whole, most people at high 

risk do not fully benefit from these therapies, because it is hard to 

apply them to the numbers involved. 

This is an example of how VA can function as a laboratory for 

finding the best ways of taking therapies which we know work and 

applying them in real life. 

Mr. Chairman, I have tried to give a few examples of the spectrum of diabetes research in Richmond and to show how it all flows 

directly from VA medical care, which is our primary focus, and I 

will be happy to answer any questions. 

Prepared statement of Dr. Zieve appears on p. 55.] 

Mr. BUYER. Thank you. 

I now recognize Dr. Robert Ferrante, the Director of Experimental Neuropathological Program, Geriatric Research, Education, 

Clinical Center, Bedford VA Medical Center. 
13

STATEMENT OF ROBERT J. FERRANTE 

Dr. FERRANTE. Thank you, Mr. Chairman, members of the subcommittee. I am pleased to appear before the committee to discuss 

Parkinson’s disease research within the VA and as it pertains to 

the Bedford VA Medical Center. 

The broad goals of the VA health care system remain constant 

in the mission to treat, cure, and if possible, to prevent disease 

while providing the best possible health care to veterans. As part 

of this mission, the VA has developed a well regarded medical and 

scientific research program. 

Brain diseases have a devastating impact upon veterans. As the 

veteran population ages, the incidence of these neurological conditions will substantially increase. The VA has made a serious commitment to improving patient care and identifying a cure for brain 

diseases, particularly Parkinson’s disease. 

Parkinson’s disease, or PD, as it is called, is the second most 

common neurodegenerative disorder, affecting more than half a 

million Americans. It is projected to surpass cancer as the second 

most common cause of death among the elderly by the year 2040. 

PD results in a loss of specific neurons in the midbrain, causing 

tremors, slow movement, stiffness, and gait problems. The disease 

is highly debilitating, interfering with employment and normal activities of daily living. 

There are approximately 50,000 new cases diagnosed each year. 

The VA medical centers treat at least 40,000 PD patients each 

year, and despite the many advances in therapy, no drug treatment 

appears to slow or prevent disease progression. 

While the specific cause of PD is unknown, a number of hypothetical causes have been suggested, with evidence for a role of 

both environmental and genetic causes. Studies have suggested 

that PD is associated with exposure to pesticides and industrial 

chemicals. Other investigations have clearly identified genetic 

mutations that contribute to PD. 

The VA has played a significant role in the current understanding of Parkinson’s disease, as evidenced by the large public 

action record of VA clinical and scientific investigators. The VA research has helped to describe the fundamental clinical, pathological, and molecular features of Parkinson’s disease and related disorders. 

The VA is now at the forefront of developing a therapy for PD. 

In 1999, the VA and the National Parkinson’s Disease Foundation 

established an alliance dedicated to finding a cure for the disease, 

confirming the VA’s commitment to understanding Parkinson’s disease. 

In 2001, as Dr. Kussman reported, the VA announced an innovative health care delivery model for veterans with Parkinson’s disease by opening six new Parkinson’s disease research, education, 

and clinical centers, PADRCC’s, as they are called, specializing in 

Parkinson’s disease research, education, and clinical care. 

Each PADRCC is involved in basic bio-medical research, rehabilitation, health services delivery, and specialized clinical trials. 

In 2003, the VA developed anational consortium network for dispersed VA clinicians to resource the VA’s expertise in PD through 
14

the PADRCC’s. The consortium is now comprised of 150 multi-disciplinary clinicians. 

I direct a research program at the Bedford VA developing therapies for neurodegenerative disorders that are particularly focused 

upon finding a treatment for Parkinson’s disease, Lou Gehrig’s disease, and Huntington’s disease. We use scientific models of Parkinson’s disease to test the effects of drug compounds to prevent the 

cell loss that may result in the clinical and pathological picture of 

Parkinson’s disease. 

Once these drugs are found to work in neurological models, 

human clinical trials are begun through the VA clinical trials program. 

We now have a number of very promising drug therapies to slow 

the progress of PD and other like brain disorders such as Lou 

Gehrig’s disease. 

The VA is an excellent and productive training ground for future 

investigators in Parkinson’s disease. The influence of the VA extends well beyond its boundaries. The success of the VA research 

program in PD is based upon strong institutional commitments by 

the medical service and a cohesive community of scientists and 

clinical investigators. 

The VA will build upon these past accomplishments and will continue to conduct research that will ultimately help in the search for 

a cure for Parkinson’s disease. The VA is positioned and ready to 

meet this challenge. 

That concludes my statement, and I would be pleased to answer 

any of your questions. 

Thank you very much. 

Prepared statement of Dr. Ferrante appears on p. 58.] 

Mr. BUYER. Thank you. 

We now recognize Dr. Mary Sano, associate chief of staff of research, the Bronx VA Medical Center. 

STATEMENT OF MARY SANO 

Dr. SANO. Thank you, Mr. Chairman and members of the subcommittee. 

Though new to the VA, I have been a researcher in Alzheimer’s 

disease for nearly 20 years, with a primary interest in developing 

strategies for the treatment and prevention of the disease. 

Currently, I am a director of a multi-center clinical trial to determine if lipid-lowering drugs can slow the progression of Alzheimer’s 

disease. This is run with a consortium of Alzheimer’s centers 

around the country and includes several other VA sites. 

The Alzheimer’s Disease Research Center, located at the Bronx 

VA Medical Center and the Mt. Sinai School of Medicine in New 

York City, which I direct, provides an infrastructure to use stateof-the-art clinical assessments of patients and to offer patients the 

opportunity to participate in cutting edge research. 

One of the most valuable resources at our medical center is the 

brain bank for Alzheimer’s disease and other cognitive disorders. 

This resource permits us to conduct clinical neuropathological correlations to determine the changes that occur in the brain with 

aging and disease. 
15

Because of the careful clinical diagnosis and electronic recordkeeping of the VA medical centers, we are able to maximize the 

very generous contribution of the volunteer veterans to compare detailed information from their medical records with subtle and microscopic changes at the cellular level and to get a clearer picture 

of the biology of Alzheimer’s disease. 

For example, the area of the brain known as the entorhinal cortex and the hippocampus appear to deteriorate very early. These 

brain areas are involved in memory and learning, and we now 

know that serious impairments in memory may predict AD several 

years before the disease can be diagnosed. 

VA has a long history of research in Alzheimer’s disease. The 

very first multi-center study for an approved treatment for Alzheimer’s was published in the New England Journal under the 

leadership of a VA physician, the former chief of psychiatry at the 

Bronx VA. This work made a longstanding contribution in that it 

provided the methodology for conducting multi-center studies for 

testing new treatments for Alzheimer’s disease. That methodology 

is still used effectively today. 

In particular, the very test used to determine drug efficacy in dementia in nearly all pivotal studies is the Alzheimer’s disease assessment scale, which was developed at the Bronx VA. Though this 

test was published nearly two decades ago, it remains the most 

commonly used assessment in clinical trials for Alzheimer’s disease 

in the United States and around the world. 

Many renowned VA AD research colleagues who have been in the 

field for many years have made important contributions from bench 

to bedside. 

This is the challenge for VA research, and it is met, for example, 

through pioneering work examining fiber-blasts and other cell 

types which have led to the first clinical trials in gene therapy for 

patients with Alzheimer’s disease. 

While finding cures and prevention are important, even our best 

efforts will leave many patients with this disease. VA researchers 

have done cutting edge work to define and maximize patient independence and comfort. This rigorous research lays the foundation 

for determining the best way to evaluate a patient’s ability to participate in clinical and research decisions. 

In summary, the success of AD research in the VA is a result of 

a series of partnerships. 

These partnerships begin with the generous spirit of the veterans 

who volunteer to participate. They include the melding of clinical 

resources such as the electronic medical records system and centralized databases, with the outstanding curiosity of the VA researchers, and it would not be possible without the research resources to make the best use of these scientific opportunities and 

the commitment to deliver the best of care. 

Thank you for allowing me to make this statement. I will be glad 

to answer questions. 

Prepared statement of Dr. Sano appears on p. 61.] 

Mr. BUYER. Dr. Kussman, I was taking note of the Office of Research and Development’s budget from fiscal year 1999 through fiscal 2003. The numbers that I have show the budget increased on 

research from 300—these are appropriated dollars—from 300—I 
16

am using approximate—309 million in 1999, increased to 392 million in 2003. I do not have the 2004–2005 with me, but there has 

been an acceleration in the budget. 

Would you please tell us about what the total—what is the total 

research dollars to the VA, not just our appropriated, but when you 

include the private companies and foundations, and if you know 

what they are for the top subject areas. 

Dr. KUSSMAN. Yes, sir. The total is about 1.1 billion. 

Mr. BUYER. About $1.1 billion? 

Dr. KUSSMAN. Yes, sir. 

Mr. BUYER. Would you have a breakout? 

Dr. KUSSMAN. The $392 million that you mentioned are the appropriate dollars. The other $700 million is about half and half between——

Mr. BUYER. When you take the $1.1, the $1.2 billion and put that 

into areas of research, would you have a breakout of how you are 

spending the money? 

Dr. KUSSMAN. We can get you that, sir. 

Mr. BUYER. I will tell you what. I will give your staff about 10 

minutes to figure that out. We will come back and ask that question. 

Dr. KUSSMAN. I have the list here of the top 10 conditions that 

we are doing. 

Mr. BUYER. There you go. Please. 

Dr. KUSSMAN. In mental health, the total number is $220 million; cancer, $157.3 million; heart disease, $81.9 million; aging, 

$71.2 million; substance abuse, $59.4 million; AIDS, $54 million; 

Alzheimer’s, $51.5 million; neurodegenerative disease, $51.2 million; diabetes, $48.8 million; and prostate disease, $41.3 million. 

Those are the top 10 conditions. 

Mr. BUYER. Of diabetes, do you know what the approximate cost 

is to the VA with regard to treatment of diabetes? About how much 

percent of your health budget is diabetes-related? 

Dr. KUSSMAN. I believe, as I mentioned to you, that about 20 percent of the patients have diabetes, and I believe about 27 percent 

of the budget is spent on diabetes. 6.8 percent of the medical care 

dollars go to the care in diabetes. 

Mr. BUYER. Wait a minute. Time out. I did not make this number up, but I read somewhere that somebody wrote that approximately 25 percent of the VA cost is diabetes-related with regard to 

health care? Is that accurate? 

Dr. KUSSMAN. Yes, sir. The total amount of dollars, because there 

is multi-factorial of the patients with diabetes have heart disease 

and other—hypertension and other things, and so, the total amount 

of the budget, as I understand it related to the full spectrum of patients with diabetes and other related costs, comes to about the 25 

percent of the total budget. 

Mr. BUYER. Would it be fair to say sometimes it is hard to determine. 

Dr. KUSSMAN. Yes, sir. 

Mr. BUYER (continuing). Doctors use testimony that half of all 

heart attacks are some form of diabetes-related or precursors, and 

so, it is relatively hard to say the exact number. 
17

Dr. Salerno, I recall testimony on the subcommittee of the commerce committee that about one-third of your Medicare expenditures is diabetes-related. Is that still accurate? 

Dr. SALERNO. I am not certain about that. 

Dr. FRADKIN. I am Judy Fradkin from the National Institute of 

Diabetes and Digestive and Kidney Diseases. The answer depends 

on whether you consider all health care costs of people with diabetes or costs that are directly related to care of diabetes itself. You 

also have to consider that illnesses that a patient with diabetes develops cost more to treat. 

For example, if a patient with diabetes has a heart attack or has 

pneumonia, they spend longer in the hospital and the cost of taking 

care of the pneumonia and the heart attack is greater for a person 

with diabetes than if the same condition occurred in a patient without diabetes. So, when we consider the costs, we are considering 

both the costs of diabetes and the added cost of conditions that 

occur in patients with diabetes that could be attributed to the diabetes. 

Mr. BUYER. Often here we look at how we leverage dollars, and 

I note that simple math here, Dr. Kussman, is that your diabetes 

research is 4.6 percent of the whole. So, what we have here are 

very limited dollars going to research in diabetes where, in fact, we 

are spending a lot of money on the back end. 

I just want to let you know we note that. 

I also understand that you have a three-minute video that shows 

some very impressive results with regard to deep brain stimulation 

with regard to the VA’s Parkinson’s research. 

Would you please share with us your video? 

Mr. KAPLAN. Roger Kaplan, special assistant chief research and 

development officer. 

This is footage of a participant prior to his DBS surgery, Mr. 

Chairman, and he is walking to a pre-selected spot which will also 

be seen in the following video. He has been off of medications for 

approximately 12 hours. 

Dr. FERRANTE. Deep brain stimulation involves exciting certain 

parts of the motor pathway in patients, so that there is constant 

stimulation as dopamine would normally do. 

Dopamine, the neurochemical that helps in movement transmission, is lost in Parkinson’s disease patients, and this helps actually as a symptomatic treatment. 

It is not a curative treatment but a symptomatic treatment, helping patients in regard to their movement disability. 

Typically, an electrode is placed in parts of the different connections over the motor system that is within the brain and constantly 

stimulates or activates that particular system, so it equilibrates the 

system, as if it would if there were normal dopamine levels. 

There is a second part to this apparatus. The apparatus is controlled by an element that is placed in the chest in order to continually stimulate the brain. 

That particular piece can be changed after a number of years, 

two to four years, depending upon the life of the system, and there 

are, in some instances, in very small instances, where relocation of 

the electrode needs to be placed and reoriented within the brain. 
18

Mr. KAPLAN. Mr. Chairman, the last video took approximately 

two minutes, 48 seconds for the veteran to stand, walk, turn 

around, return to his chair and sit down. We will now show you 

footage of the same veteran following his DBS surgery. 

[Videotape is played.] 

Mr. BUYER. That is remarkable. 

Mr. KAPLAN. Approximately 20 seconds, Mr. Chairman. 

Mr. BUYER. How long does this surgery take, the procedure? 

I mean tell us a little bit about how long—how difficult—and the 

cost. 

Dr. FERRANTE. Usually, deep brain stimulation, in the past, was 

used primarily when other pharmacologic treatments were no 

longer working. 

Typically, some of the symptomatic treatments using L-dopa and 

combinations of L-dopa had difficulty in their clinical use after five 

to six years, and deep brain stimulation was used primarily for patients having difficulty with symptomatic drug treatment. 

We now understand or have an understanding that DBS may be 

used well in symptomatic treatment in many PD patients. Surgical treatment is relatively expensive. It costs $20,000 per 

patient. 

The implantation requires in-patient neurosurgery. Again, there 

is an electrode that is placed from the top of the skull and placed 

within certain parts or a single part of the motor system that helps 

to control it. In some events, two electrodes are placed in the 

brain—one in both sides, so that there is bilateral implantation of 

electrodes, and the system is operated via a connection from under 

the skin and back into the chest. 

Mr. BUYER. Who has the patent on this? Was this done based on 

VA research dollars, and if so, was there a cooperative technology 

administration agreement with the founders? 

Dr. KUSSMAN. Mr. Chairman, I’m not sure I can answer the 

question about who has a patent, but right now, it is approved by 

the FDA. 

We have a cooperative study going on now, and our patients basically have the option of participating in the study or getting the 

deep brain stimulation off study, because it has been approved by 

the FDA as an acceptable therapy. 

My understanding of the study is that it is one of the largest 

studies going on in the country to look at more than one site of the 

stimulation in the brain and compare it to the medical therapy. 

We are about halfway through that cooperative study, and we 

hope to have some exciting results from that. 

Mr. BUYER. If I could ask for tolerance from my colleagues for 

just a follow-up question, what I am trying to ask here is, for a 

long time, the VA and NIH, both, but particularly the VA, we have 

invested a lot of money, and we are trying to seek our patent rights 

from the government, because we invest the taxpayers’ dollars and 

these universities and others then reap benefits, and from the VA, 

we want those benefits to come back to the VA. 

So, I was just curious, and if you do not have the answer today, 

if you could get us for the record whether or not any VA research 

dollars were part of this, and if so, was there a cooperative agreement with regard to patents. 
19

I now yield to Ms. Hooley for any questions she may have. 

Dr. KUSSMAN. We will have to get back to you. 

(See p. 89.) 

Mr. BUYER. Okay. Thank you. 

Ms. HOOLEY. Thank you, Mr. Chair. 

The subcommittee selected those three disease that are prevalent 

in the aging population. 

Dr. Salerno, what other diseases are out there that you think 

will be a serious threat to the aging population in the future? 

Dr. SALERNO. The diseases that affect the main causes of death 

and disability in the country—cancer, heart disease, stroke—are 

also, diseases of aging, and the costs associated with it are because 

people are also living longer with these diseases as we have been 

able to increase survival. 

Ms. HOOLEY. What disease do you think will be the most costly 

in the future? 

Dr. SALERNO. Well, it is hard to speculate, because it really depends on how well we do with finding effective interventions. 

For instance, the cost of caring for an Alzheimer’s patient for one 

year is over $30,000, and as the population ages, unless we find effective interventions, it will be at a cost of hundreds of billions of 

dollars to the health care system. 

Ms. HOOLEY. In your testimony, you talked about the sharp increase in the number of patients with Alzheimer’s and that it is increasing and there will be a threefold increase by 2050. Do you 

foresee some kind of—a cure or help or preventative measures that 

can happen in the next 40 years? 

Dr. SALERNO. Well, I began in Alzheimer’s research in the late 

1980s, and the words ‘‘prevention’’ and even ‘‘treatment’’ were not 

in our vocabulary then. I think that the pace of the science in the 

last 15 years has been remarkable. 

We now understand more about the disease, about the basic biology of the disease. We are now understanding—getting closer to 

being able to make a more definitive diagnosis in living human 

beings. 

We have remarkable technology that helps us image the living 

brain, and all of these things, I think, have really pointed us in a 

direction where we are very optimistic that, while we cannot predict when we see cures or more effective treatments but that we 

are certainly headed in the right direction, and I think that this 

is a testimony to the payoff from the great Federal investment in 

research in this area. 

Ms. HOOLEY. To any members of the panel, is there anything—

we talked about—in diabetes, we talked a lot about what we can 

do to prevent diabetes. I mean it is lifestyle, it is weight, it is exercise, those sorts of things. 

What can the average person do to help prevent Alzheimer’s and 

Parkinson’s? If I went out and said, you know, if you do this, it will 

help delay it, it will not come on as fast, what are those preventative measures a person could do? 

Dr. SANO. Because we have a disease that occurs so late in life, 

it is difficult to answer these questions. However, we do have epidemiology studies that have suggested to us that many of the 

things that keep one’s heart healthy also may keep their brain 
20

healthy. There is evidence that control of weight and lipids may be 

important. There is evidence that keeping oneself active is also important, both cognitively active and physically active. 

These are not guarantees, but there seems to be a strong connection between taking care of your general health and keeping your 

cognition high for as long as possible. 

Ms. HOOLEY. Anybody else? 

I have one other question. Actually, I have a whole bunch of 

other questions, but when you look at research dollars from VA, 

NIH, do you look at putting more money into those areas that are 

the most costly? I mean when we talk about how much it costs to 

treat a person, for example, with diabetes and all the other related 

problems, or how much it costs to treat somebody with Alzheimer’s, 

do we ever match the research dollars with those diseases that 

are—affect more people and that cost more? I mean is that ever 

done? 

Any one of you. 

Dr. SALERNO. At the NIH, each individual institute is given a 

separate appropriation by Congress, but within that, we all develop 

strategies for our investment to maximize—for instance, in the National Institute on Aging, about 50 percent of our budget, about 

half a billion dollars, goes to Alzheimer’s research, because it is one 

of the most pressing public health issues that we are facing. 

Ms. HOOLEY. So within the aging budget, 50 percent. 

Dr. SALERNO. Yes. 

Ms. HOOLEY. What percent of the budget is for aging for NIH? 

Dr. SALERNO. Well, again, it is difficult to tease that out specifically. 

We have some idea by diseases. For instance, all of Alzheimer’s 

research is about $650 million across the NIH, but there are diseases of aging that affect almost every organ system, and so, we 

try to leverage, just the way there is leverage with the VA research 

dollars, we try to leverage our investment so that, for example, we 

invest in putting an aging focus in comprehensive cancer centers 

to—to cut across all of the areas that are important. 

Dr. O’LEARY. This is Dr. O’Leary. From the VA perspective, we 

are actually currently reviewing the portfolio allocations to better 

understand the relationships, but it is a combination of things that 

goes into decisions. 

Certainly, much of our research is driven by the patient population that we see, because that is reflected by the clinician population that develops good ideas that should be funded. 

In addition, though, there are areas that are sometimes targets 

of opportunity, which seem to be a little bit more ripe for research 

investment. The presence of targets of opportunity also has an influence on the way research dollars are invested. Finally, as mentioned just a moment ago, the leveraging opportunities not only 

with other groups that can fund, but also opportunities within a 

particular research project. In many cases research, particularly 

our basic research is not really just devoted to a single disease but, 

in fact, can have implications for treatment of a number of different diseases and conditions, and so, the portfolio is kind of hard 

to match one-to-one with a disease. 
21

Ms. HOOLEY. I know there is probably not a one-to-one match, 

but what are—I mean as you are looking at the diseases, the opportunities in that relationship, what do you see on the horizon? 

Dr. O’LEARY. Well, there are a variety of things. 

First of all, we have military-unique things to consider, things 

that are affecting our veterans as they come immediately off active 

duty, particularly now, and this is getting into an area of very high 

attention and priority. Certainly, areas like diabetes, mental 

health, and the neurodegenerative diseases have all been areas in 

which there are targets of opportunity. Infectious diseases have 

been targets of opportunity. 

The delivery of health services, the way to most effectively use 

our resources in order to get veterans the care they need is also 

part of our research focus. Finally, there is a very special emphasis 

in VA on rehabilitation research and particularly things that have 

to do with spinal cord injury, which has been one of the great success stories of VA research. 

Ms. HOOLEY. Thank you. 

Mr. BUYER. Mr. Evans, you are recognized? 

Mr. EVANS. Thank you, Mr. Chairman. 

On this issue of the deep brain stimulation, why isn’t it more 

prevalent? I think it has not been utilized particularly, and if that 

is true, what, if any, of the effects would be helped by deep brain 

stimulation? 

Since every Parkinson’s disease patient has different symptoms, 

how do we determine what is a success? Is it elimination of all 

those different symptoms? 

Dr. FERRANTE. There are a number of treatment therapies, and 

those that currently work best are the symptomatic therapies. 

Deep brain stimulation is considered to be a symptomatic therapy. 

As with any of the pharmacological treatments, a patient needs 

to be closely monitored and watched, and that equally occurs with 

deep brain stimulation in regard to the constant pulsing of certain 

parts of the brain. 

It is thought that dopamine constantly pulses the motor system 

to keep it in balance, and it is the use of this particular technique, 

deep brain stimulation, that provides symptomatic relief. 

You are absolutely correct, sir, that each patient is, in large degree, going to be treated individually, and it is important that 

there be continued assessment of the progress in regards to their 

motor abilities with this particular symptomatic treatment. 

Dr. KUSSMAN. Sir, maybe I could add just a little bit to that response, if I might. 

We have a quality indicators project going on, looking at what 

the quality indicators would be for outcomes related to patients 

with Parkinson’s disease, and these have been established by subject matter experts, and so, we can try to assess the different 

therapies with the different symptom complexes, looking at these 

quality indicators, and then follow the patient appropriately. 

So that’s one of our projects. 

Mr. EVANS. From my understanding, the VA is not giving the 

stimulation at this point for veterans, or is that not a problem? 

What is the eligibility of a veteran for getting these treatments? 
22

In other words, what I am asking is who is going to determine 

who gets the expensive treatment? We have 40,000 veterans, as 

one of you had testified. If we had that many, how much would 

that cost, or is the VA actually not doing the deep brain stimulation? Are they just doing research at this point? 

Dr. KUSSMAN. No, sir. We are doing it—as I mentioned earlier, 

I think—two processes—one is the research project, but we are also 

doing it for patients on a routine basis, if you can ever say it is 

routine, because it is an accepted, approved FDA modality of therapy for Parkinson’s disease. 

So you do not have to be part of the research project if you don’t 

want to. 

Mr. EVANS. Okay. All right. 

Thank you, Mr. Chairman. 

Mr. BUYER. Mr. Boozman, do you have any questions? 

Dr. Salerno, on page 2 of your testimony, you state that ‘‘Partnerships with VA researchers have strengthened our search for 

ways to delay and ultimately to prevent the devastation of Alzheimer’s.’’

Could you elaborate on the partnerships that are involved? 

Dr. SALERNO. Certainly. 

The 29 Alzheimer’s disease centers from across the country have 

multiple interactions with VA sites, and in fact, there is an overlap 

with places like Bedford and the Bronx. 

Dr. Sano is a VA researcher, and she is also funded by National 

Institute on Aging in her Alzheimer’s work, and she is part of the 

Alzheimer’s disease center consortium group for research. 

So there is considerable overlap, and in the centers where there 

is co-located GRECC, as well, there is a lot of opportunity for interactions, and it is a seamless interaction, since I have been on the 

VA side and the NIH side, and I can attest to that, and there are 

a number of GRECC researchers, too, the Geriatric Research Education Clinic Centers, who are perhaps not involved in the ADC 

centers but are also funded, and again, the—I think it has been 

very fruitful in terms of leveraging the opportunities and the resources and maximizing the investment from both sides. 

Mr. BUYER. Dr. Sano, what would be your views on the collaborative effort? 

Dr. SANO. Well, the collaboration really permits a wide range of 

benefits. The opportunity for the VA physicians to work closely 

with the researchers in the local affiliate is a strong method for 

strengthening the research environment. It is also an advantage to 

the patient population, since together they can get the most opportunities to participate in the cutting edge of the most recent research. 

Mr. BUYER. Dr. Salerno, what are the top 10 funding priorities 

in research at NIH? Do you know? 

Dr. SALERNO. For the entire NIH? 

I can probably—I cannot speak for all the other institutes, but 

I can speak to one major priority, and that is our director Dr. 

Zerhouni’s road map, and that is where we are looking at issues 

and opportunities which cannot be accomplished by one institute 

alone, that we need to invest in new scientific pathways, re-engineering the clinical research enterprise, and developing the re-
23

search teams of the future so that we will be poised to take advantage of those opportunities, and those are really cross-cutting, and 

the grant funds available from our road map activities are available for all researchers across all disciplines and all areas of interest. 

So that is really, I think, what we are doing to really make sure 

that we can rapidly not only find discoveries—make these discoveries but disseminate them so that they translate into real health 

gains for the U.S. population. 

Mr. BUYER. Ma’am, if you could, for the record, let us know what 

are the top 10 funding priorities in research at NIH, I would appreciate that. 

I also recognize in the director’s comments that he made about 

his road map that fingers without a palm does not make a hand—

I thought that was a pretty good analogy, and just as here in the 

VA we are trying to eliminate these stove pipes and have greater 

interaction and operabilities and the sharing of information between different agencies—you have how many, 17? No, you have 

27? 

Dr. SALERNO. Twenty-seven different institutes and centers. 

Mr. BUYER. You all cannot talk to each other. It just blows my 

mind. 

Dr. SALERNO. We are trying. 

Mr. BUYER. I know. You are getting there. We want to help you 

in that endeavor. 

On page 11 of your testimony, you talked about a new program 

called MOVE, an acronym for Managing Overweight and Obesity 

Among Veterans Everywhere, which was developed by the VA National Prevention Center with assistance from NIH scientists and 

is being piloted at 17 facilities. 

How long will this pilot last, and how many individuals will be 

involved? 

Dr. SALERNO. Could I ask Dr. Fradkin to respond to that? 

Mr. BUYER. Yes. 

Dr. SALERNO. She’s been involved in that effort. 

Dr. FRADKIN. We just heard a presentation about this at our Diabetes Mellitus Interagency Coordinating Committee. This is a Congressionally established committee that is now in its 30th year 

which addresses this whole stove piping issue that you were just 

talking about. It brings together 23 different components of the 

government to work together on diabetes. 

The MOVE program was developed with assistance from NIDDK 

scientists who have been directly involved with the obesity research 

effort and are very familiar with best practices that have been developed with NIH resources. They then worked with VA scientists 

to develop a program that could be implemented in the VA. 

I believe that it is being piloted now at the VA, and then based 

on the results of those pilots, the VA will make a decision as to future deployment of resources. I think the VA, rather than the NIH, 

would be best able to speak to what the VA’s plans are for that program. 

Mr. BUYER What tools are you using for measurable outcomes? 

Dr. KUSSMAN. Yes, sir. 
24

The MOVE project has been led by the VA center in Durham for 

the prevention and—it is being piloted. It is a very aggressive program, and we are very excited about helping people in the whole 

spectrum of exercise and wellness and the purposes related to 

weight issues in the whole spectrum of diseases. 

There are a set of criteria—and we will be happy to give you a 

official report on that that looks at the program and sets up the 

performance standards and things that we will be happy to report 

back to you. 

(See p. 89.) 

Mr. BUYER. Thank you. 

Ms. Hooley, you are now recognized. 

Ms. HOOLEY. Thank you, Mr. Chair. 

Anyone on the panel, does it make any difference if you have 

early diagnosis of Parkinson’s or Alzheimer’s, and what tests do 

you use to diagnose people early for those two diseases? 

Dr. SALERNO. Well, I can speak to the Alzheimer’s early diagnosis. 

That is a key element of our research strategy right now, because 

we believe that the changes occur in the brain at least a decade 

before there is any clinical symptoms and that since it is a disease 

of aging that even delaying the onset of symptoms by five years 

would have a remarkable impact on the incidence of the disease 

and also the quality of good cognitive life. 

So we do not have a definitive way to diagnose at this point, but 

we have a multi-prong effort for research to help us develop the 

early diagnostic tools. 

Ms. HOOLEY. So if you diagnose them early and you say you can, 

you know, delay the onset for five years, how do you delay the 

onset? What do you do with that early diagnosis? 

Dr. SALERNO. Well, that is our hope, that some of the interventions, some of which look promising and are in clinical trials now 

in early Alzheimer’s patients, that if we can put them into—if we 

can use them before there are any symptoms, that since we know 

these diseases slow the progression, it may slow them enough for 

a long enough period of time so that you will be in a clinically disease-free state for longer periods of time. 

Ms. HOOLEY. One of the tests I want to ask about—research have 

recently developed the first radio-tracers, including a molecule 

called Pittsburgh compound B, that facilitate visualization of depositions in living AD patients using PET scans. Do you use that? Is 

that procedure used in the VA? 

Dr. SALERNO. This is a very new research finding, just came out 

within the past few months——

Ms. HOOLEY. Okay. 

Dr. SALERNO (continuing). And it needs to be confirmed and we 

need far more data, but it is the first time that there are clues that 

we can visualize the pathologic changes in the brain of an Alzheimer’s—of a person early in the disease. So, this is—these kinds 

of things are where we hope to see the payoff so that we can really 

define the diagnostic techniques that will lead to the early interventions. 

Ms. HOOLEY. Has this been used at the VA? 
25

Dr. KUSSMAN. Not that I am aware of, because it is considered 

a research project right now, and as it evolves and if it turns out 

to be something that would be appropriate therapy, obviously we 

would use it as we do all other types of appropriate therapy. 

Ms. HOOLEY. What do you use to diagnose Alzheimer’s right 

now? I mean if you talk about early detection—I mean why would 

a person go and say, gee, you know, I need to be tested? Is it because you have parents, family members? Is it hereditary? Why 

would I go and get an early diagnosis for Alzheimer’s or Parkinson’s, I mean either one of those? 

Dr. SANO. In the case of Alzheimer’s disease, one of the earliest 

detections is memory impairment, and it is particularly when memory problems are noted by someone in the family of the patient, by 

a loved one, who notices a change. 

The value of doing that early is that one can make the most use 

of the current treatments, but it is also to ensure the safest environment that they can live in while they have even these early 

symptoms and can allow them the maximum freedom if they know 

limitations very early on. 

Ms. HOOLEY. What do you use to diagnose it? 

Dr. SANO. The diagnosis is based on documenting the memory 

impairment, the functional loss, and the potential behavioral problems and ruling out any other medical conditions that might contribute to those kind of problems. 

Ms. HOOLEY. What do you use to diagnose Parkinson’s, and is it 

important to also get to that early? 

Dr. FERRANTE. Well, again, it is a clinical diagnosis, and as with 

many of the neurodegenerative disorders and neurologic diseases, 

there is some specificity in that regard. 

There is an issue with Parkinson’s disease. There is a phenomenon referred to as Parkinsonism, that results in Parkinson’s 

disease-like conditions, and so it is important, as Dr. Sano has indicated, to clearly differentiate which is idiopathic Parkinsonism, 

which we are talking about here today, versus other disorders. 

I think one of the very important partnerships that have recently 

developed between NIH and the VA is the translational program, 

identifying bio-markers and a variety experimental models to characterize those bio-markers, as well as to identify selective neuroprotective therapies. 

Ms. HOOLEY. Is it important to have an early diagnosis? Does it 

make a difference if you have an early diagnosis of Parkinson’s or 

not? 

Dr. FERRANTE. Yes, it does in regard to the patient’s clinical care. 

However, one of the issues is that we still do not know the causal 

event of Parkinson’s disease. 

Ms. HOOLEY. So we cannot postpone that if we know it early. 

Dr. FERRANTE. Yes, we can. We can slow the desease process 

with neuro-protective drug compounds, and as I was saying, the 

partnership between VA and NIH is currently identifying drug 

treatments that will slow or prevent continued neuron loss in the 

brain. 

Ms. HOOLEY. Okay. Thank you. 

Mr. BUYER. Mr. Evans, you are now recognized. 

Mr. EVANS. Thank you, Mr. Chairman. 
26

Do we know how many veterans have been given the brain stimulus treatment in the VA in the last year or so? 

Dr. KUSSMAN. A hundred and thirty-eight. 

Mr. EVANS. Okay. 

Thank you, Mr. Chairman. 

Mr. BUYER. Mr. Boozman? 

Mr. BOOZMAN. Yes. 

Mr. Zieve, in your presentation, you talk about the problems related to diabetes in relation to heart disease, and yet, you know, 

when we hear others testify in other settings, the main concern 

seems to be with blindness and kidney failure. 

Is there a reason that you have kind of hit the heart disease 

harder? 

Dr. ZIEVE. In people who present with diabetes at an early age, 

blindness and kidney failure, the microvascular complications, are 

the biggest problem they run into, and these are preventable. 

In the adult age group, the VA age group, and the majority of 

people with new diabetes today, they are not going to go blind from 

their diabetes, because they are going to die of a coronary first. 

We actually wish that we had more of a problem with preserving 

vision, but we have to get by this tremendous vascular incidence 

first, and I think probably what has happened is, number one, diabetes is being a little better controlled so the people are living 

longer, and number two, because of the increased prevalence of 

obesity in our society, the diabetic is a little heavier, he is a little 

more insulin resistant, he is going to be at a little more heart attack risk. Coronary disease is the big blight on Type 2 diabetics 

today, and this is going to become an increasing problem at younger ages, because the obese teenagers who are presenting with diabetes at age 15 are going to present with their coronaries at age 

35 or 40. 

Mr. BOOZMAN. So, this really is kind of a change that you are 

seeing a little bit with the, like you said, increase in diabetes and 

just the poor health to begin with. 

Dr. ZIEVE. Yes. 

Mr. BOOZMAN. Good enough. 

You mentioned the metabolic syndrome several times, and this 

really was not something that we had heard about until the last 

few years. Now we have a whole clinic, you know, devoted to it. 

What is the deal with that? 

Dr. ZIEVE. Actually, this has an interesting history. I think you 

could probably trace the concept back to the Bronx VA hospital in 

1958 when Berson and Yallow developed the ability to assay the 

plasma insulin level and for which Yallow later got the Nobel 

Prize—Berson had died prematurely of a coronary before that—and 

they took a group of Type 1 diabetics and found that their circulating insulin level was zero. 

They took a group of Type 2 diabetics, expecting it to be low, and 

found that their insulin level was higher than it was in normals. 

So, obviously, insulin was not working right. 

That was the first indication that there was a problem with insulin resistance, and subsequently, over the last several years, as 

obesity has become more of a problem, as diabetes has become 

more of a problem, it has become recognized that the pre-diabetic 
27

state is also a group of people who are at tremendously high coronary event risk, and that is a group that is getting bigger every 

year. 

So both the NIH, the National Cholesterol Education Project, and 

the World Health Organization, within the past five years, have defined criteria for identifying the metabolic syndrome people, and 

our feeling is these are the people who have the heart attacks, that 

is where our prevention efforts ought to be focused. 

Mr. BOOZMAN. One other thing. I know in the—I am from Arkansas, and the VA in Little Rock has a really good program where 

they have the ability to screen retinas, you know, from other—in 

other words, you know, a practitioner can see something that they 

are really not sure about. Rather than make that person take a 

trip to Little Rock, you know, they can scan the image, you know, 

retinal photography, and then somebody there read all of those. 

Is that the type of thing that we need to be doing more of in the 

VA system? 

Dr. ZIEVE. Yes. Yes, I think it is, and in the general community, 

too, but it is going to be easier to do it in the VA because of telemedicine hookups that are possible. I think this sort of thing is tremendously valuable in picking up early disease, because basically 

nobody should ever go blind from diabetic retinopathy. 

First of all, with meticulous control from the start, the retinopathy is preventable, and even when you get it, laser surgery is tremendously effective at preserving vision if you know about it early 

enough. 

Mr. BOOZMAN. Thank you very much. 

Mr. BUYER. It is kind of unusual to go to a third round. I still 

have questions. 

Ms. HOOLEY. I have just one. 

Mr. BUYER. Go ahead, Ms. Hooley. 

Ms. HOOLEY. No, go ahead. You are first. 

Mr. BUYER. No, go ahead. You are eager. You are ready to go. 

Ms. HOOLEY. All right. 

Are there any applications of the deep brain stimulation that we 

use for Parkinson’s that can be used in treating Alzheimer’s patients? Is there any research on that? Anyone of you, anyone in the 

room. I do not care. 

Dr. SANO. Many of the areas that we know are important in Alzheimer’s disease for better neuron communication are also areas 

that have potential for having seizures, and so, the model of brain 

stimulation in Alzheimer’s disease is not really well developed, for 

that reason, because those many cortical areas are areas that, if 

stimulated, are more likely to be associated with side effects, such 

as seizure. 

Ms. HOOLEY. Okay. Thanks. 

Dr. FERRANTE. I think equally important is that there is primarily one brain area involved in Parkinson’s disease, where it is 

multi-factorial in Alzheimer’s, with many sub-cortical as well as 

cortical areas that are involved in Alzheimer’s disease. So, in order 

to select out one in Alzheimer’s disease would be very difficult to 

do. 

Mr. BUYER. I would like to go back to the—with regard to VA 

research and the top 10 conditions—and I want to make sure 
28

whether or not this is fair or not for me—when I look at the list 

of the top 10 for which you had testified, is it fair to say that, when 

I look at the dollar amount and—if I were to put them in a declining scale on dollars, is it fair to say that this would then be the 

priority of the VA with regard to your research budget? So, when 

you say mental health, 220 million; cancer, 157 million; heart disease, 81.9 million; aging, 71.2 million; substance abuse, 59.4 million, etcetera, is it fair to say that I link dollars to priorities or not? 

Dr. KUSSMAN. I do not think there is necessarily a direct correlation with that, to be honest. 

Clearly, these are disease entities that are important to us in the 

treatment of the veterans, and so, clearly, as you can see from the 

numbers that were listed, mental health research was number one. 

It’s clearly serious, the mentally ill, and other—drug and alcohol 

and other issues related to that are very important to the VA, as 

well as cancer and heart disease and aging. 

So I don’t think it is a mistake that these are near the top, but 

I would not go so far to say that they were prioritized in any particular way that mental health was considered number one versus 

cancer or heart disease. 

Mr. BUYER. So it would not be fair to link a dollar amount with 

regard to a particular condition as a barometer with regard to your 

priorities? 

Dr. KUSSMAN. I believe that that would be a fair statement, sir. 

Mr. BUYER. Okay. 

Do you, within the research arena—do you prioritize? Do you say 

one through five or one through 10? 

Dr. O’LEARY. Unfortunately, Mr. Chairman, I am relatively new 

to this position, and I cannot speak to the history. What I can say 

is that we are actively reviewing the portfolios now to understand 

the relationships better. We have conducted some preliminary reviews, but we also remember as we are doing this that we have 

some special populations of veterans that we have been asked to 

give special consideration to in our research funding priorities, and 

these include things like prosthetics, spinal cord injury, rehabilitation, Gulf War research, and so, these kinds of things will have an 

influence because of the special role of VA in some of these areas 

that differs substantially from that of the NIH or others in making 

their funding allocations. 

Mr. BUYER. Thank you. 

This is only my opinion; it is not the opinion of others. When 

Congress doubled the NIH budget to push the bounds of science to 

betterment of our society, we recognize that you have been a great 

influence upon other research throughout the country. There is a 

multiplier effect of that and a stimulus that goes into the private 

sector, which then comes back around, it is almost circuitous. What 

I am most hopeful about is that that impact of that five-year investment does not de-focus the VA with regard to its veteran-centric research priorities. 

Now, that is just my opinion, so I cannot speak for the committee. So that is the reason I asked this particular question. 

So are you in discussions or have you also noticed to make sure 

that veteran-centric priorities with regard to all population is extremely important and that we are not de-focused, yet we recognize 
29

that our research can have attributes to the betterment of our society, but let us not de-focus the purpose of the VA research. Would 

you concur or not concur and comment, please? 

Dr. KUSSMAN. Yes, sir. I think that that is what Dr. O’Leary was 

alluding to, re-evaluating and assessing and being sure that we 

don’t lose focus on things that are particularly important to the 

veteran. 

As you know from the discussion and other things, there is a tremendous overlap with—things that are important to the VA are 

clearly important to society, as well, but as mentioned, there are 

some things that are fairly unique to the VA patient population 

that we would like to emphasize. 

Mr. BUYER. Something I thought was rather interesting, sort of 

a side note—one of the benefits of being on the health subcommittee of Commerce—Dr. Zerhouni, if I pronounced that 

right—when he came and testified and we talked about sexually 

transmitted diseases, there is a—I forgot the word he used to describe it—80 million Americans—80 million—80 million Americans 

have been exposed to sexually transmitted diseases in a country of 

300 million—oh, epidemic, a public health epidemic. It is pretty 

stunning when you think about, okay, all of our research and what 

we are doing and where we focused, yet with regard to sexually 

transmitted diseases—I am not talking strictly AIDS—venereal 

diseases and herpes, et cetera—but when I went and looked at the 

VA, then, in this whole question about centric research and veterans, interesting input from the VA—and you could comment or 

not, Dr. Kussman—is that, with regard to sexually transmitted diseases, total funding for fiscal year 2003 was 985,000 for 14 projects. 

In comparison, there were almost 8,200 total patient visits in fiscal year 2003 for sexually transmitted diseases out of almost 50 

million total patients’ visits. It is interesting. 

So here is a prime example of numerator and denominator, everything just all of a sudden flipping, society having a major problem, public health epidemic, with regard to NIH. 

Tell one of your comrades over there to open up their eyes—or 

colleagues—open up your eyes with regard to funding priorities for 

a public health epidemic. Yet, within our veterans population, we 

are not having the equivalent epidemic. 

So I only bring this up as we are trying to—I am trying to pay 

attention with regard to our population versus what is happening 

also in society’s population with regard to our limited dollars and 

how we invest. That is why we asked you to come here today with 

regard to aging diseases for the collaborative efforts, but yet we do 

not want to be de-focused. 

Do you see what I am trying to say? Do you concur with what 

I have just said, Dr. Kussman? 

Dr. KUSSMAN. Yes, sir. 

Mr. BUYER. All right. 

The last thing I have, with regard to the—Dr. Salerno, your experts who are here—if they could please provide some testimony 

right now—let us know what are the cutting edge project that you 

are working on, clinical trial that you are so excited about you cannot wait to get out of your chair and tell us about with regard to 

the three diseases. 
30

If you could slide over, Dr. Salerno, and let someone have a seat. 

Dr. MURPHY. I am Diane Murphy from the National Institute on 

Neurological Disorders and Stroke, and one of our more exciting 

trials you have already heard a lot about today, which is the collaborative trial on DBS between the Veterans Administration and 

our institute, but we have also started a trial to test 

neuroprotectants in early stages of Parkinson’s disease, and Ms. 

Hooley actually questioned a little bit about this earlier. 

The idea of the trial is to pilot some drugs that may delay the 

progression of disease or retard the progression of Parkinson’s disease so that patients can stay in a manageable state for much 

longer, and we have funded 51 sites around the country, and we 

are going to be testing—piloting right now drugs like creatine and 

co-enzyme Q, any drugs which have shown promise in acting as 

neuroprotectants, and at the end of this pilot period, one of those 

drugs will be selected for a large-scale clinical trial. 

Mr. BUYER. Next? We have six minutes to do this. 

Dr. FRADKIN. I think that there has been an explosion of knowledge—— Mr. BUYER. Identify yourself for the record. 

Dr. FRADKIN. I am Judy Fradkin from the National Institute of 

Diabetes and Digestive and Kidney Diseases. You heard from Dr. 

Zieve about some of the research that the Richmond VA Hospital 

have been doing on leptin. This is a piece of the larger explosion 

of research that has been going on with regard to understanding 

the biologic basis of appetite regulation, and of control of metabolism and responsiveness to insulin. All of these processes are integrated by a whole new series of chemical messengers that have 

really just begun to be identified. 

This creates tremendous opportunity in terms of developing targets for drug discovery and new therapeutics. 

As this hearing has emphasized, prevention is key for diabetes. 

Obesity is a major contributor to diabetes risk. We have, on the one 

side, a very successful trial of lifestyle interventions that have been 

shown to be very effective in preventing or developing development 

of diabetes. 

On the other hand for people who aren’t able to change activity 

and diet—and this is difficult in an environment that promotes 

obesity and a sedentary lifestyle—we now have a whole new series 

of potential biologic targets that may help us develop other kind of 

therapeutic interventions. 

Mr. BUYER. Thank you. 

Next? 

Dr. MORRISON-BOGORAD. One of the major things which I think 

is most promising in Alzheimer’s disease research is trying to stop 

cell death and stop the loss of connections between nerve cells that 

actually seems to relate most closely to loss of cognitive function, 

and there are a number of avenues of research that actually cross 

a number of neurodegenerative diseases which are focusing on the 

accumulation of the abnormal proteins in Alzheimer’s disease and 

Parkinson’s and how this can be stopped. 

There are a number of ways this is really being looked at, and 

one is in Alzheimer’s, to stop the accumulation of the amyloid protein and its deposition into plaques, and so, we have, through ge-
31

netic research and basic molecular research, a tremendous understanding how of the pathways through which plaques are generated, and there are perhaps six or eight targets, now that we 

know these pathways, where researchers are working to stop 

plaques being formed or to remove them once they have been 

formed. 

One avenue which took quite a setback a couple of years ago but 

which I think is extraordinarily promising is the vaccine approach 

that you probably heard about, where a clinical trial had a problem 

in that the vaccine of amyloid did create neurological complications 

in some of the people in the trials, and so, the trial was stopped, 

but what researchers are back doing now is to try to find a safer 

way of vaccinating the person against amyloid so that the plaques 

will be removed. 

Another very important line of research is perhaps a little bit 

simpler, and that is one of the essences of our approaches, is, one, 

to look at very complicated ways of stopping the disease, developing 

new drugs, developing new compounds. 

Another is to go back to epidemiology studies and see whether 

something as basic as antioxidants in the diet might help slow the 

development of the disease, as well as perhaps slow aging, as well, 

and we have a number of very promising studies in rodents and 

also in dogs which suggest that antioxidants really slow development of cognitive decline, and so, these perhaps are two of the most 

promising areas that I would like to tell you about. 

Mr. BUYER. That is great. Thank you very much. 

I would like to thank my colleagues for their contributions. I 

would like to thank NIH and the VA for being here. These are very 

important collaborative efforts which you have ongoing. 

Dr. Kussman, if I would note, the subcommittee held a hearing 

on September 19th of 2002 on VA research and research foundations. At the time, I had asked the Under Secretary how many affiliated universities had signed cooperative agreements in what is 

commonly called the cooperative technology administration agreements, which we had referred to earlier. At the time, Dr. Roswell 

stated that such notable universities as Yale, Duke, Emery, University of Michigan, had not established these agreements. I had 

asked for the funding stream over the last 10 years of the top universities. They ranged at close to $100 million between NIH and 

the VA. 

So I take, for example, Duke University. With regard to Duke, 

this effort to sign these agreements started in 2000, and we got a 

copy of a letter just signed yesterday to the committee from Duke 

University saying, well, we are still working on it. 

I would like for somebody to come over and brief the committee, 

this subcommittee, with regard to an update with regard to getting 

these agreements signed with these universities, all right? 

Dr. KUSSMAN. Yes, sir. 

Mr. BUYER. All right. Thank you very much. 

The hearing is now concluded. 

[Whereupon, at 12:00 p.m., the subcommittee was adjourned.] 

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CHAIRMAN BUYER TO DR. KUSSMAN
90Æ