WRITTEN STATEMENT OF
JOEL KUPERSMITH, MD
CHIEF RESEARCH AND DEVELOPMENT OFFICER
DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE
HOUSE COMMITTEE ON APPROPRIATIONS
SUBCOMMITTEE ON MILITARY CONSTRUCTION, VETERANS' AFFAIRS AND RELATED AGENCIES

March 14, 2007

*

Mr. Chairman and members of the Subcommittee, thank you for the opportunity to appear before you today to discuss the Department of Veterans Affairs (VA) medical and prosthetic research program's fiscal year ( FY) 2008 budget request. I appreciate this invitation to discuss the important work of VA research. With me are Dr. Timothy O'Leary, Director of Biomedical Laboratory and Clinical Science Research and Development, and Dr. Robert Ruff, Acting Director of Rehabilitation Research and Development. I would like to take this opportunity to give an overview of VA's research program.

Let me first say that the future of medicine is determined by research. The advances in medicine that we have all grown to expect will not occur without research, just as many of the medical advances of the past 50 years brought about by VA would certainly not have occurred without research. I am sure that you are familiar with the many awards won by VA investigators - 3 Nobel prizes, 6 Lasker awards, and others. But what is more important is the large number of treatments and procedures that have been developed and proven by VA investigators. VA research has been a highly valuable investment with very substantial returns for veterans first and the Nation as a whole.

Introduction

VA's research program was developed as part of the post-World War II effort to discover knowledge and create innovations that advance health and healthcare for veterans and the Nation. VA research has taken special advantage of its connection to clinical care and is replete with examples of how VA investigators have improved care, including:

• Numerous advances in prosthetics, including better-fitting and lighter artificial limbs, prosthetics that can sense, artificial hands that are capable of very fine motion, the Seattle foot, a great early example of these advances, and many others,
• Pioneering understandings of post traumatic stress disorder (PTSD) and improving the treatment of PTSD to significantly reduce trauma nightmares and other sleep disturbances, including most recently prolonged exposure therapy, which holds great promise,
• Identifying genes associated with Alzheimer's disease, schizophrenia, and premature aging,
• Developing computer software that led to computerized axial tomography (CAT scan),
• Pioneering research efforts leading to new home dialysis techniques,
• Developing the nicotine patch and other therapies to help smokers give up the habit,
• Implanting the first cardiac pacemaker, and many other advances for abnormalities of heart rhythm, high blood pressure, and coronary artery disease,
• Developing a system that decodes brain waves and translates them into computer commands that allow quadriplegics to perform simple tasks like turning on lights and opening e-mails by using only their minds, and
• Numerous other advances in improving care and its delivery.

• A series of hypertension studies which form the cornerstone for treatment of this condition,
• One of the first studies to determine the long-term effects of coronary artery bypass surgery,
• An investigative study on the use of cortisone to treat patients with septic shock,
• A landmark study showing that aspirin reduces deaths and heart attacks in patient with unstable chest pain,
• A vaccine for shingles, and
• New treatments for PTSD.

But past success is not enough. Research must always be future-oriented. We must look at how we practice healthcare today and ask: how can we do better? VA's research program builds on its past by identifying and confronting the important questions and challenges of today and conducting the hard work to find solutions for the future.

VA Research as a Unique Laboratory

A particular advantage of VA research is that it is an intramural program where clinical care and research are under one roof. For this reason, it has the capacity to bring scientific discovery from the patient's bedside to the laboratory bench and then back to the care of patients, making this program one of VA's most effective tools to continue improving the care of veterans. Embedding research within an integrated healthcare system with a state-of-the-art electronic health record creates a national laboratory for the discovery of new medical knowledge and the translation of that knowledge into improved health. Furthermore, the opportunity to conduct research assists VA in recruiting outstanding clinicians and creates a culture of continuous learning and innovation that helps VA maintain its position of leadership.

Additionally, VA research has a unique program, the Quality Enhancement Research Initiative (QUERI), which creates durable partnerships between VA researchers, policy-makers, and clinicians to accelerate the implementation of research evidence into routine practice. Allow me to give you one example of this fine program - administration of influenza and pneumococcal vaccine to individuals with spinal cord injury. It had been found that the rate of vaccination in these individuals was unacceptably low. To address this, QUERI investigators formed a partnership with VA's spinal cord injury leaders and were able to increase the vaccination rate from 28% and 40% to 61% and 79% for influenza and pneumococcal vaccine, respectively. After three years, this QUERI initiative was stopped. As all of you are aware, some research efforts create only temporary improvements that are lost once the project terminates. However, in this case, the vaccination rates did not decline after termination of the initiative, and in fact increased even further to 65% and 82%, respectively. This occurred because VA researchers worked within VA's health delivery system to make lasting changes in the process of care. I think this exemplifies the value of having research and clinical care under one roof, working together to improve the delivery of care.

Information Technology (IT) Security and Privacy

It is important to note our efforts in IT security and privacy protections. The following are among the steps VA research has taken, in close collaboration with the Office of Information and Technology, to strengthen IT security and privacy:

• Mandatory, new checklist assuring IT security for all research files, certified by the Information Security Officer and Medical Center Director,
• Mandatory, new IT security and privacy courses for all research personnel,
• Implementation of the Department's approved data security technologies/solutions for laptops, removable storage media, mobile devices, and transmission of VA protected information that traverses the VA network,
• Deferment of research at health services Research Enhancement Award Program (REAP) centers,
• Creation of a Web site and e-mail address for policy directives, frequently asked questions concerning research IT policies, checklists, and other items,
• National teleconferences to reinforce the importance of IT security and privacy,
• Initiation of a process for Performance Measures concerning IT security and privacy, and
• Discussions and data use agreements with other federal agencies, as well as the Association of American Medical Colleges, concerning collaborative research IT files.

In addition, VA has implemented rigorous technical and administrative controls to protect the security and privacy of patient information used in the course of approved research projects. Every researcher seeking access to protected information must receive specific approval to access that information from a VHA Privacy Officer. The Privacy Officer works closely with the Office of Research and Development to ensure that access is granted or denied in accordance with federal law - including the Privacy Act, the Federal Information Security Management Act (FISMA), and the Health Insurance Portability and Accountability Act (HIPAA) - and further, that access is restricted to the minimum information necessary to support the approved research protocol.

Funding Priorities of VA Research

VA research focuses on the special healthcare needs of veterans. To accomplish the VA research mission, the President's 2008 budget request includes $411 million to support VA's medical and prosthetic research program. This amount will fund nearly 2,100 high-priority research projects to expand knowledge in areas critical to veterans' healthcare needs. The VA medical care appropriations also include an additional $411 million for research activities. In addition to VA appropriations, VA researchers compete for and receive funds from other federal and non-federal sources. Through a combination of VA resources and funds from outside sources, the total research budget in 2008 will be almost $1.8 billion.

The following highlights some of the current funding priorities for VA research.

Research Related to Returning Operation Iraqi Freedom and Operation Enduring Freedom ( OIF/ OEF) Veterans and Deployment Health. VA has implemented a comprehensive research agenda to develop new treatments and tools for clinicians to ease physical and psychological pain, improve access to VA healthcare services, and address the particular health issues of OIF/ OEF veterans. This research also has direct relevance for veterans of other conflicts, as well as for civilians suffering from disability due to injury or disease.

It is important to note that last week the President created an Interagency Task Force on Returning Global War on Terror Heroes (Heroes Task Force), chaired by the Secretary of Veterans Affairs, to respond to the immediate needs of returning Global War on Terror service members. The Heroes Task Force, which had its first meeting last week, will work to identify and resolve any gaps in service for service members. As Secretary Nicholson said, no task is more important to VA than ensuring our heroes receive the best possible care and services. VA research is helping to ensure that our heroes do receive the best possible care.

Specific areas of focus in OIF/ OEF and deployment health related research include:

Neurotrauma (including traumatic brain injury and spinal cord injury). Although Kevlar helmets and improved body armor save lives, they do not protect the head, face, and cervical spinal cord from blast and impact injuries. Accordingly, traumatic brain injury (TBI) and spinal cord injury (SCI) account for a significant number of the combat casualties sustained by our soldiers in OIF/OEF.

In 2005, VA issued a solicitation for research in combat casualty neurotrauma. This research initiative seeks to advance treatment and rehabilitation for veterans who suffer traumas from improvised explosive devices and other blasts. The solicitation is still active and applicants are asked to pay special attention to cooperative projects in TBI with the Department of Defense ( DoD), co-morbid conditions with TBI such as PTSD and trauma to extremities, screening and diagnostic tools related to mild TBI, especially field-based, and continuity of care between DoD and VA. Neurotrauma studies underway span the full spectrum of VA supported research and include those in neurobiology, protection and prevention of injury, drug treatments, and treatments to enhance attention and cognition.

Mental Health and PTSD Research. VA's combat-related mental health research portfolio includes studies about addictive disorders (including nicotine dependence), the behavioral consequences of TBI, PTSD, and depression. In addition, VA health system studies are focusing on how to integrate mental health services into primary care, thereby improving access to needed care as well as reducing the stigma associated with mental illness.

VA investigators are working to understand the course of the readjustment experience and to identify PTSD risk factors and treatment response for veterans returning from OIF/ OEF as well as from other conflicts.

In one study, VA researchers collaborating with DoD are collecting risk factor and health information from military personnel prior to their deployments to Iraq. These soldiers will be reassessed upon their return and several times after that to identify possible changes that occurred in emotions or thinking as a result of their combat exposures and to identify predisposing factors to PTSD as well as other health conditions.

In addition, in 2006, VA initiated a new center-based program of research to examine biological mechanisms and potential treatments for PTSD complicated by secondary drug abuse. Such dual-diagnosis patients have proven difficult to treat in the past.

VA investigators are also examining new treatments of PTSD, including the very promising prolonged exposure therapy and various kinds of drug treatments in refractory cases.

VA supports a broad research portfolio on depression, including investigations of cognitive behavioral therapy and new types of drug treatments. VA is unique in its ability to use research to design and test new ways of delivering care to veterans, such as collaborative care models in which professional mental healthcare is integrated into VA primary care practices, thereby increasing the effectiveness of mental healthcare, and tele-health, which uses Internet-based technologies to bring state-of-the-art care into veterans' homes and communities.

Prosthetic Devices and Amputation Healthcare Research. VA research continues to expand its support of multidisciplinary research and examination of enabling technologies to ease the physical and psychological impacts of limb loss. A primary goal is to generate rigorous data that can drive policy and shape clinical care guidelines.

While traditional prosthetic and amputation healthcare research has focused on mechanical limb prostheses, VA is expanding its focus to include novel approaches such as tissue engineering and surgical treatment for residual limb lengthening, joint replacement and attachment of prostheses, as well as incorporating advanced materials, microelectro-mechanics, and nanotechnologies into current prosthetic designs. One innovative approach has involved investigating the control of prostheses through direct brain activity. The overarching goal of all these initiatives is to maximize the functional recovery and well-being of veterans who have compromised limb function as a result of combat injury.

VA is also partnering with DoD to compare prosthetic designs, define standards of function, evaluate psychological issues faced by returning service personnel, determine psychosocial issues that challenge successful reintegration, and conduct longitudinal outcome studies.

Polytrauma. Improvements in body armor and battlefield medicine have resulted in higher survival among wounded soldiers, but also, in some cases, new combinations of multiple injuries, including head injuries, sensory loss, nerve damage, infections, emotional problems, amputation, and/or SCI. This is a new challenge for VA and VA research is working to develop the knowledge base to manage these conditions over the lifetime of the veteran.

In 2006, VA established a Polytrauma and Blast-Related Injury Quality Enhancement Research Initiative (PT/BRI QUERI) coordinating center to use the results of research to promote the successful rehabilitation, psychological adjustment, and community reintegration of these veterans. The PT/BRI QUERI links VA investigators with VA's Polytrauma system of care, including the four lead centers located in Minneapolis, Richmond, Tampa, and Palo Alto. The Polytrauma QUERI has two particular emphases: to accelerate the diffusion and use of new knowledge generated by VA research in the areas of neurotrauma, sensory loss, prosthetics, and amputation, and to identify and address the needs of informal caregivers such as spouses or parents in order to allow veterans to remain in home and community-based settings.

Gulf War Veterans' Illnesses. Many individuals returned from the 1990-1991 Persian Gulf War with unexplained medical symptoms and illnesses. Nonspecific symptoms such as fatigue, weakness, gastrointestinal difficulties, cognitive dysfunction, sleep disturbances, headaches, skin rashes, respiratory problems, and mood changes that often occur together in a constellation have been termed Gulf War veterans' illnesses (GWVI). Despite a large number of studies and considerable funding over the past decade, the etiology and successful treatment of GWVI remains elusive. VA research continues to expand its efforts to understand and improve the treatment for Persian Gulf War Veterans.

Several studies have shown that Persian Gulf War veterans have up to a two-fold greater risk of developing amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, than those not deployed to the Gulf. ALS is a tragic condition characterized by progressive muscle wasting and weakness. The diagnosis of ALS is based on the patient's history and clinical findings. There is currently no single test that is specific for ALS, so it may take up to two years to confirm the diagnosis.

VA investigators recently identified three proteins that were significantly lower in concentration in the cerebrospinal fluid from patients with ALS than in normal subjects. The combination of these three proteins correctly identified patients with ALS with 95% accuracy from normal subjects. The change in content of these three proteins may help identify patients with ALS early in the course of the disease.

Beyond OIF/ OEF and deployment health related research, VA's research funding priorities include several areas affecting the larger veteran population, including:

Mental Health Research. Mental health research is spread throughout many parts of the VA's research portfolio. The scope of VA's mental health research includes studies about:

• Addictive Disorders,
• PTSD/Adjustment Disorders,
• Schizophrenic Disorders,
• Dementias,
• Neural Mechanisms of Brain Disorders,
• Mood Disorders,
• Mental Disorders Following Brain Damage,
• Mental Healthcare Service,
• Sleep Disorders, and
• Anxiety Disorders.

Examples of VA mental health research projects currently underway include multi-site cooperative studies such as "Improving Outcomes among Patients with Co-Occurring Depression and Diabetes," studies about TBI and its behavioral consequences, and research centers in the areas of addictive disorders and serious mental illness.

Genomic Medicine. Genomic medicine is the direction for healthcare in the twenty-first century. Genomic medicine could allow VA to provide care that is tailored specifically to the genetic makeup of individual veterans, increasing the effectiveness and safety of healthcare and disease prevention efforts, while protecting privacy. VA is uniquely situated to combine the research and clinical application of genomics because of VA's large patient population that is stable, diverse, and treated in a variety of settings; healthcare system with outstanding investigators and an integrated research network; and, unrivaled electronic health record. Taking advantage of these factors inherent in VA, VA intends to develop a genomic medicine program that could considerably improve the care of veterans.

In March 2006, VA research took the first step toward establishing a genomic medicine program by impaneling a Genomic Medicine Program Advisory Committee of internationally recognized scientists and veterans' advocates to help lay the groundwork for future development of a comprehensive genomic medicine program in VA.

Specifically, the genomic medicine program will help VA:

• Prevent adverse drug reactions - already proven in treatment of certain cancers where low levels of a genetically determined specific enzyme called thiopurine S-methyltransferase can cause life-threatening drug-induced suppression of blood cell production;
• Personalize clinical care - for example, there are genes related to blood clotting that are very important in patients undergoing surgery for trauma and other conditions or immobilized for long periods of time;
• Customize drug treatments - for example, some antipsychotic drugs have rare and severe adverse effects that are likely to be genetically determined. Identification of these genetic dispositions will greatly improve screening and the use of these drugs; and,
• Improve care - genetic analysis is now part of standard care of treatment for many cancers including leukemias, lymphomas, brain tumors, colon cancer, and breast cancer. It is used for screening, diagnosis, and to determine responsiveness to chemotherapy and radiation.

Chronic Diseases. Promoting good health and managing chronic conditions remain high priorities for VA healthcare and VA research. The following are examples of efforts by VA investigators to discover how to prevent and treat chronic disease.

Diabetes. Nearly a quarter of the veterans receiving care from VA have diabetes, and an even greater number (73%) are at risk due to overweight or obesity. VA investigators have completed the first study to compare the quality of diabetes care among patients in VA and commercial managed care organizations. Quality of care measures were compared for seven diabetes processes of care, three diabetes intermediate outcomes, and four dimensions of satisfaction. Results from this study showed that VA patients had better scores than commercial managed care patients on all assessed quality of care measures. VA patients also had better lipid control and were slightly more satisfied with the overall quality of diabetes care at VA. All of this is considerably enhanced by the electronic health record that enables precise evaluation and follow-up of diabetic patients.

Obesity. The VA patient population, like that of the U.S. in general, is experiencing an epidemic of overweight and obesity. Obesity contributes to increased heart disease, diabetes and sleep apnea, and other health conditions. Examples of VA obesity research include studies about traditional and new approaches to prevent and treat obesity such as comparing lower extremity functional electrical stimulation (FES) on obesity and associated co-morbidities to upper extremity aerobic exercise for persons with paraplegia; assessing the impact of walking aids on quality of life and physical activity in overweight and obese veterans with osteoarthritis; and exploring drug therapies.

HIV/AIDS. AIDS (acquired immunodeficiency syndrome) is caused by HIV (human immunodeficiency virus). VA is the largest single provider of HIV care in the U.S., with nearly 20,000 patients seen annually with the disorder. Accordingly, VA research funds a full range of studies from bench research aimed at elucidating the underlying mechanisms of HIV to implementation projects that improve VA's effectiveness in caring for this population.

A recent study by VA researchers found that routine HIV screening is cost-effective even in low prevalence populations, because early treatment with highly active antiretroviral therapy can reduce the degree of infectivity and transmission of the HIV virus, improve quality of life and increase life expectancy for the patient, and reduce healthcare costs for the system. Such research has helped shape VA policy for HIV care (e.g., implementation of rapid HIV testing) and also influenced the Centers for Disease Control and Prevention to recommend that HIV testing be offered to all adults.

Alzheimer's Disease. Alzheimer's disease is the most common form of dementia (loss of mental abilities) among older people. Alzheimer's disease involves the parts of the brain that control thought, memory, and language, and people with Alzheimer's disease have memory problems, may become lost in familiar places, and get disoriented about time and places. VA related studies include discovery of new links between diabetes and Alzheimer's disease, examination of dietary treatments, and many others.

Substance Abuse. Alcoholism and dependence on other drugs are a major problem in the VA patient population. While environmental stressors contribute to the development of alcoholism, a substantial part of an individual's risk for becoming an alcoholic is inherited.

A group of more than a dozen scientists at VA's Alcohol Research Center has been studying alcoholism for over 20 years. This group is recognized as one of the world leaders for behavioral genomics studies of alcoholism and substance abuse. The scientists have discovered a gene, the Mpdz gene, related to alcoholism and the methods they introduced for gene mapping have been widely adopted.

Women's Health. In response to the increasing number of women veterans, documented expansion of the number of women in the military, and special healthcare needs of female veterans, VA has focused additional attention on women's health research. VA has developed a comprehensive women's health research agenda including a new priority research solicitation on women's health. Examples of VA research studies relevant to women veterans' health include further understanding the cellular mechanisms underlying breast and cervical cancers, the role of hormones in stroke and aging, further characterizing basic neurobiological changes in women who have undergone severe trauma, and specific prosthetic designs for women. Together with a strong mental health research program, VA research is well positioned to continue to enhance healthcare for women veterans.

In 2006, VA investigators served as guest editors and prominent contributors to a special supplement of the Journal of General Internal Medicine that focused on VA women's health research. Articles describe research on the health and healthcare delivery of female veterans, including diabetes care, PTSD, and obesity, and highlight issues related to access to care, the quality of VA women's healthcare, and VA organization and policy.

Long-term Care. Meeting the long-term care needs of veterans is growing in importance as the number of veterans most in need of these services - those 85 years old and older - is expected to increase to 1.3 million by 2012. In addition, a new younger population of veterans with different long-term and care coordination needs is emerging as a result of the OIF/ OEF conflicts.

Many veterans prefer to receive long-term care in non-institutional settings, so they can stay connected with their community and loved ones. However, the success of such long-term care is critically dependent on the ability of veterans' family and friends to assist in their care. Caregiver burden is common and frequently limits the ability of family and friends to provide that assistance. Caregiving also can have significant negative consequences on the health and well-being of caregivers, yet little is known about how to ameliorate the impact of the burden of care. VA research has initiated several efforts aimed at understanding and supporting the needs of caregivers, including special efforts targeted through the QUERI program to survey the needs of caregivers of blast injury and TBI patients, and a new research initiative focused on developing new approaches to community-based long-term care.

Conclusion

Because over 70 percent of VA researchers are also clinicians who take care of patients, VA is uniquely positioned to move scientific discovery from investigators' laboratories directly to patient care. In turn, VA clinician investigators can identify new research questions for the laboratory at the patient's bedside, making research one of VA's most effective tools to continue improving the care of veterans. The fundamental goal is to address the concerns of the entire veteran population from the aging veteran to the young recruit who returns with injuries from recent conflicts. VA takes great pride in the research that keeps it at the forefront of modern medicine and healthcare and expects to see further remarkable discoveries in the coming decades. VA research has been a wonderful investment with remarkable returns.

Mr. Chairman, that concludes my statement. I am pleased to respond to any questions you or the Subcommittee members may have.

Thank you.