Joel Kupersmith, M.D.
Mr. Chairman and members of the Subcommittee, thank you for the invitation to appear before you today to discuss the Department of Veterans Affairs (VA) medical and prosthetic research program. I appreciate this opportunity to discuss the vital role VA research and development has in ensuring the health and well-being of our Nation’s veterans. With me are Dr. Timothy O’Leary, Director of Biomedical Laboratory and Clinical Science Research and Development, and Dr. Michael Selzer, Director of Rehabilitation Research and Development.
Let me first say that the future of medicine is determined by research. Just as the advances in medicine that save and improve lives today would not have occurred without yesterday’s research, the advances in medicine that we have all grown to expect will not occur without today’s and tomorrow’s research.
Dating back more than 80 years, VA research has been a valuable investment with remarkable and lasting returns for veterans and the Nation as a whole. I am sure that you are familiar with the many awards won by VA investigators—3 Nobel prizes, 6 Lasker awards, and many others. But what is more important is the large number of treatments and procedures that have been developed and effectively proven by VA investigators. VA research has taken special advantage of its connection to clinical care and is replete with examples of how it has improved care, including:
- Developing numerous advances in prosthetics, including better-fitting and lighter artificial limbs, prosthetics that can sense, artificial hands that are capable of very fine motion, a biomechanical foot, and the Seattle foot—a great early example of these advances;
- Pioneering understanding of and treatment for post-traumatic stress disorder (PTSD), including exciting new treatment advances proving the effectiveness of prolonged exposure therapy and a drug to significantly reduce trauma nightmares and other sleep disturbances in PTSD;
- Identifying genes associated with Alzheimer’s disease and premature aging;
- Laying the groundwork for the development of the computerized axial tomography (CAT) scan;
- Pioneering research efforts leading to new home dialysis techniques;
- Developing the nicotine patch and other therapies to help smokers quit;
- Developing the cardiac pacemaker and many other advances for abnormalities of heart rhythm, high blood pressure, and coronary artery disease; and,
- Developing a system that decodes brain waves and translates them into computer commands that allow tetraplegics to perform simple tasks like turning on lights and opening e-mails by using only their minds.
VA’s Cooperative Studies Program deserves special mention. It has received national media attention for its groundbreaking work improving treatment for a host of critical medical conditions, including:
- A series of studies that established the cornerstone for treatment of hypertension;
- One of the first studies to ascertain 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 that showed aspirin reduces deaths and heart attacks in patient with unstable chest pain;
- A vaccine for shingles;
- New innovative drugs and therapies to treat PTSD; and
- A study that showed balloon angioplasty plus stenting did little to improve outcomes for patients with stable coronary artery disease who also received optimal drug therapy and underwent lifestyle changes.
But past success is never enough. Research must be future-oriented. 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 occur together under one roof. For this reason, VA 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 improve the care of veterans. Embedding research within an integrated health care 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 ensuring VA’s continued leadership in health care.
Additionally, VA research has a unique program, the Quality Enhancement Research Initiative (QUERI), which creates durable partnerships between VA researchers, clinicians, and policy-makers to accelerate the implementation of research evidence into routine practice. Allow me to give you one example of this innovative program— administration of influenza and pneumococcal vaccine to individuals with spinal cord injury. People with spinal cord injury are at higher risk for influenza and pneumonia. To increase these patients’ rates of vaccination, VA QUERI investigators partnered with VA clinical leaders in spinal cord injury. Working together, they increased the rate of influenza vaccination from 28 to 61 percent, and the rate of pneumonia vaccination from 40 to 79 percent. These improvements continued even after the initiative ended, with the vaccination rates reaching 72 and 86 percent, respectively, when last measured.
This advance for veterans with spinal cord injury can be attributed to researchers working within VA’s health delivery system to improve 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.
Priorities of VA Research
Each year we re-evaluate our priorities based on the changing needs of the veterans we serve, and strive to fund the highest quality science that meets those priorities. The following are some of the current priority areas for VA research:
- Research related to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans and deployment health;
- Mental health;
- Personalized medicine;
- Chronic diseases;
- Access to care;
- Long-term care; and
- Women’s health.
Details about these priority areas are given below.
Research Related to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) 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 health care services, and address the full range of health issues of OEF/OIF 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.
Specific areas of focus in OEF/OIF and deployment health related research include:
- Traumatic Brain Injury (TBI) and Other Neurotrauma
Although Kevlar helmets and improved body armor save lives, they do not protect against blasts and impacts to the head, face, and cervical region of the spinal cord. Those that survive blast force and impacts may suffer injuries to internal organs, limb loss, sensory loss, paralysis, cognitive loss, chronic pain, and psychological disorders.
To advance the treatment and rehabilitation of soldiers returning with these types of injuries, VA issued a request for research proposals that focus on TBI; cervical spinal cord injury (SCI); co-morbid conditions such as PTSD and trauma to extremities; screening and diagnostic tools related to mild TBI, especially field-based; and continuity of care between the Department of Defense (DoD) and VA. Applicants were asked to pay special attention to cooperative projects with DoD.
Many exciting projects have emerged from this solicitation and other funding mechanisms to help veterans suffering from TBI, including: (1) studying neural repair after brain injury to build a better understanding of cognitive rehabilitation, as well as find potential targets for practical treatments that enhance quality of life; (2) developing a project exploring community re-integration for service-members with TBI (to promote seamless transition between service members currently being treated, or who will one day be treated, in both DoD and VA medical facilities); and (3) several studies assessing the relationship between TBI and PTSD and their impact on health outcomes.
In addition, several VA scientists with expertise in neuroimaging and neuropsychology are turning their efforts to further understanding the brain changes that occur in TBI. This is important because following TBI there may be subtle or distinct brain damage that results in memory, attention, thinking, and personality changes that are difficult to diagnose and treat with current knowledge. A new study will start this year combining state-of-the-art imaging techniques (e.g., three-dimensional brain imaging and diffuser tensor imaging to examine white matter changes) with comprehensive neuropsychological assessments to fully characterize patients with TBI compared to other types of brain damage such as stroke. Knowledge from this study will help inform rehabilitation and diagnostic strategies.
VA researchers are also studying many ways to help veterans with SCI. Investigators are developing practical functional electrical stimulation systems that may allow individuals with incomplete SCI to walk. VA researchers are also preparing to conduct clinical studies of a neuroprosthetic system for restoration of hand–arm function in veterans with a cervical level SCI. It is hypothesized that users will demonstrate significant improvements in their pinch strength, range of motion, and their ability to perform grasp-release tasks with their hands and also show better control of their forearms and elbows. VA investigators are also testing microstimulators to recreate breathing and coughing patterns that will avoid respiratory complications which are currently the leading cause of death in SCI patients. Further, VA researchers are continuing to improve the mobility and function of veterans with SCI and other disabilities through innovative engineering for wheelchairs and other assistive technologies.
In one exciting study, VA researchers and others recently demonstrated that a neuromotor prosthesis (NMP) could enable a tetraplegic to operate an artificial hand, robotic arm, computer, or television by using only his thoughts (Nature. 2006; 442(7099):164-171). A NMP is a brain-computer interface that helps replace or restore lost movement in paralyzed patients. This technology uses an electrode that picks up brain signals and sends them to a computer for decoding. The brain signals are translated into commands to power electronic or robotic devices, including prosthetics.
One of the most common conditions in returning OEF/OiF veterans due to blast exposure is tinnitus (ringing noise in the ear). VA researchers are developing a diagnostic test to identify this condition, which is currently done by self-report. In collaboration with DoD, VA investigators are planning a study to determine which auditory processing disorders are more often associated with exposure to high-explosive blasts, whether there is spontaneous recovery of auditory function after blast exposure, how much recovery may be expected, and how rapidly it occurs.
In addition, VA investigators are developing behavioral strategies to cope with conditions of low vision and blindness. VA researchers also continue to make progress on the development of an artificial retina for those who have lost vision due to retinal damage. As reported in one recent publication, the threshold electrical current needed to stimulate the retina of a rabbit in which the device was implanted was very low (Journal of Neural Engineering. 2005; 2(1):S48-S56). This was encouraging because using lower currents would reduce the chance of damage to surrounding eye tissue. Analogous approaches may prove useful in combat-related vision loss.
- Combat-related Mental Health
Among active duty Army and Marine Corps personnel who participated in combat during OEF/OIF, 11.2 – 17 percent reportedly met screening criteria for major depression, generalized anxiety disorder, or PTSD. These areas of readjustment mental health disorders are actively being pursued in ongoing VA research.
In a landmark ongoing 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 afterwards, to identify possible changes that occurred in emotions or thinking following their combat duty in Iraq and to identify predisposing factors to PTSD as well as other health conditions. To date, researchers have already reported that troops who had served in Iraq showed mild deficits in some tasks of learning, memory, and attention, but scored better on a test of reaction time, compared with non-deployed troops. The researchers have proposed longitudinal follow-up studies to determine if these neuropsychological effects might fade over time, or be a precursor to PTSD (Journal of the American Medical Association. 2006; 296(5):519–529). An additional goal for this research is to examine the neuropsychological associations of TBI with the development of PTSD at long-term follow-up.
Veterans with PTSD commonly experience nightmares and sleep disturbances, which can seriously impair their mood, daytime functioning, relationships, and overall quality of life. In an exciting new treatment development, VA investigators have found that prazosin, an inexpensive generic drug already used by millions of Americans for high blood pressure and prostate problems, improved sleep and reduced trauma nightmares in a small number of veterans with PTSD (Biological Psychiatry. 2007; 61(8):928–934). Plans are underway for a large, multi-site trial to confirm the drug’s effectiveness.
One of the more interesting recent findings in PTSD research being pursued in the field now is the idea that traumatic memories may be “extinguished” or weakened with a medication administered as the memory is “replayed” or reactivated under controlled circumstances. A small clinical trial is being conducted to determine whether the drug, propranolol, is more effective than a placebo in reducing PTSD symptoms such as hyper-arousal, re-experiencing, or avoidance when a distressing memory is reactivated. Research participants will be veterans of the Iraq or Afghanistan conflicts.
In addition, VA investigators are currently conducting the first ever clinical trial of a medication to treat military service-related chronic PTSD. It will also be the largest placebo controlled, double-blind study of its kind ever conducted, meaning that it is the most rigorous type of clinical trial. It will involve 400 veterans diagnosed with military-related chronic PTSD from 20 VA medical centers (VAMCs) nationwide. The main objective of the study is to determine if risperidone is effective in veterans with chronic PTSD who continue to have symptoms despite receiving standard medications used for this disorder.
Risperidone is being studied since it has been shown to be safe and has received the most study in the treatment of PTSD patients.
Veterans from all eras may experience chronic pain related to traumatic injuries. Accordingly, VA has issued a solicitation for research proposals that seek to develop novel approaches for the treatment and management of chronic pain associated with TBI, SCI, amputation, and burn injury that may result from OEF/OIF deployment as well as multiple sclerosis and other disorders.
Excruciating pain is experienced by more than 50 percent of patients after SCI. VA investigators have identified a particular form of sodium channel (of which there are more than 10) responsible for conveying pain signals to the brain (Nature. 2006; 444(7121):831-832). VA researchers are now exploiting this finding to develop a new pain treatment.
In addition, VA and DoD are jointly funding a study to examine the short- and long-term benefits of implementing early advanced regional anesthesia techniques for pain control following major traumatic injuries to extremities encountered during OEF/OIF combat. It is hoped that these techniques will result in a significant reduction in pain disability as well as in the incidence and severity of mental health disorders due to early pain intervention on the battlefield.
It is well-known that limb trauma causing fractures and/or nerve injuries can lead to the development of a disorder called complex regional pain syndrome (CRPS). To address this issue, VA researchers have developed a rat fracture model resembling CRPS. Using molecular approaches, the investigators will attempt to characterize chronic changes in key mediators such as cytokine signaling after limb trauma, which will demonstrate the feasibility of promising new treatments for post-traumatic pain and inflammation. This work could potentially be an important step towards the ultimate goal of improving clinical efficacy and safety in the pharmacologic management of CRPS.
- Prosthetics and Amputation Health Care
While nearly two-thirds of adult amputations may arise due to peripheral vascular disease of the lower extremity, they are complemented by those necessitated by trauma, in the present case, the trauma related to high explosive blasts or through other combat scenarios. High-impact explosive trauma from improvised explosive devices has become the signature injury of the OEF/OIF theaters.
Tendon losses are common in military trauma and in degenerative diseases such as rheumatoid arthritis and osteoarthritis. In mutilating injuries, a tendon grafted from another part of the individual’s body may improve function; however, only a limited supply of these tendon grafts exists. VA investigators are working to create biocompatible tissue-engineered tendon grafts, which will have wide applicability in improved reconstruction of extremities for veterans.
In addition, joint cartilage may be lost or degenerated as a result of trauma, disease, or aging, which leads to reduction in mobility and quality of life. VA investigators are using tissue engineering methods to develop an implant that can help regenerate cartilage.
The care of the wounds following amputations has been the subject of extensive research. This type of wound care is particularly challenging, owing more to the conditions surrounding the original injury than those of the surgery. VA researchers are investigating three management strategies in current standard of care for residual limbs after surgery: (1) soft dressings, (2) rigid plaster dressing, and (3) commercial prefabricated rigid prostheses. Studies of this nature are critical to a better understanding of wound care in a variety of settings extending from the “dirty” wound characteristic of a roadside bombing all the way to the healing capacities in an elderly diabetic veteran. These kinds of studies can potentially improve outcomes of amputations and burns. Most critically, improved wound healing methodologies actually have the potential to minimize the need for amputation itself.
VA researchers are also developing improved materials and designs of prostheses. In addition, VA investigators are gathering information about how prosthetic devices are used, amputee satisfaction, comparisons of selected prosthetic devices, associated costs, and various prosthetic procurement alternatives, so VA can better match technology to an individual veteran’s needs.
Another project that is underway involves building a new flexible externally powered two-degree-of-freedom prosthetic wrist for use in upper-extremity prostheses. This will provide prosthetic users with electric–powered prosthetic components that interact with objects in a more lifelike fashion and devices that will be more robust and less prone to mechanical failure.
Currently available prostheses for trans-tibial (below the knee) amputees do not help promote normal walking; in fact, their “passive” design can result in balance difficulties and slow walking speed. VA has funded research that addresses this problem by developing a powered ankle–foot prosthesis that promises to help restore amputees’ ability to walk normally. A preliminary study involving three trans-tibial amputees confirmed the benefits of the new prototype: the patients expended less energy during walking, had fewer balance problems, and walked 15 percent faster. This device has recently received significant media attention.
As a result of new modes of injury (improvised explosive devices), improved body armor, and surgical stabilization at the front-line of combat, more soldiers are returning with complex, multiple injuries (“polytrauma”), including amputations, brain and spinal cord injuries, eye injuries, musculoskeletal injuries, vision and hearing loss, burns, nerve damage, infections, and emotional adjustment problems.
In response, VA has established a Polytrauma and Blast-Related Injury (PT/BRI) QUERI coordinating center to promote the successful rehabilitation, psychological adjustment, and community reintegration of these veterans. Two priorities have been identified: (1) TBI with polytrauma, and (2) traumatic amputation with polytrauma. The primary target is OEF/OIF VA patients, many of whom remain on active duty during their initial course of treatment in VA. However, the center’s activities will benefit all VA patients with complex injuries, regardless of service era and mechanism of injury.
The PT/BRI QUERI is working closely with VA Polytrauma Rehabilitation Centers (PRCs) to identify needs and gaps in care, as well as best practices. For example, one needs assessment study found that PRC patients are demographically and clinically different from inpatient rehabilitation patients treated before OEF/OIF. The systems of care, facilities, and individual health care teams are rapidly changing to meet the needs of these unique patients.
VA also recently issued a special solicitation for research projects on the long-term care and management, including family and community reintegration, of veterans with polytrauma, blast-related injuries, or TBI.
- Gulf War Veterans’ Illnesses
While there were few visible casualties associated with the 1990–1991 Gulf War, many individuals returned from this conflict 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 causes and successful treatment of GWVI remain illusive. VA continues to expand its efforts to understand and treat GWVI.
There is also persistent concern that Gulf War veterans may be at increased risk for amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease), multiple sclerosis (MS), and brain cancer, as a result of their service. In addition to the studies that examine the causes and treatment of these diseases in the general veteran population, VA is funding studies to examine them specifically in Gulf War veterans. Accordingly, VA is supporting a broad research portfolio composed of studies dedicated to understanding chronic multi-symptom illnesses, long-term health effects of potentially hazardous substances to which Gulf War veterans may have been exposed to during deployment, and conditions or symptoms that may be occurring with higher prevalence in Gulf War veterans.
Beyond OEF/OIF and deployment health related research, VA’s research priorities include several areas affecting the larger veteran population, including:
Mental Health Research.
In addition to combat-related mental health, VA continues to support a strong behavioral and psychiatric disorders research portfolio focused on further understanding and treating mental health problems in veterans. Investigations are directed toward substance abuse, PTSD, adjustment and anxiety disorders, psychotic disorders, dementia and memory disorders, and related brain damage. Many laboratory studies are being conducted to better understand the changes that take place when someone is suffering from adjustment problems or mental illness. Clinical trials are underway to test novel drug and therapy treatments specifically targeted to help veterans. Additionally, VA has a strong program for developing and implementing better mental health care, including enhancing collaborative care models, improving access to mental health care through innovations such as telemedicine and the Internet, and reducing barriers to veterans seeking mental health care. Several ongoing projects are investigating how veterans with mental illness might benefit from rehabilitation approaches, including vocational rehabilitation, skills training, and cognitive therapy to improve everyday functioning and work performance. Future research will enable VA to determine how to care for veterans with mental illness so that they can return to their highest level of functioning.
Personalized medicine means tailoring care to the individual, in this case the veteran. In 2006, VA launched the Genomic Medicine Program as part of its Personalized Medicine Initiative. Genomic medicine is the direction for health care in the twenty-first century. It could allow VA to provide care that is tailored specifically to the genetic makeup of individual veterans, increasing the effectiveness and safety of health care and disease prevention efforts. Currently, VA is funding over 140 research projects related to genomics. These include studying the complete set of DNA of many people to determine what genetic changes are associated with a certain disease (genome-wide scans), the role of specific genes, and genetic determinants of variable responses to drugs (pharmacogenomics). These studies are investigating the role of genetics in many diseases of importance to veterans—including psychiatric disorders (e.g., schizophrenia, depression, PTSD, and anxiety); cancers of the prostate, breast, colon, lung, and bladder; heart disease; diabetes; Alzheimer’s disease; stroke; Parkinson’s disease; autoimmune disorders, including rheumatoid arthritis and lupus; GWVI; and chronic viral infections such as HIV.
VA investigators recently conducted a genome-wide search for schizophrenia susceptibility genes. The study included 166 families with more than two affected individuals, from seven VAMCs. There are 216 affected sibling pairs in these families, comprising the largest North American sample of schizophrenic sibling pairs to date. Preliminary data from the researchers’ genome scan suggest the involvement of a small region on chromosome 18. The team will continue to narrow the search by fine-mapping this region and seeking specific genes.
VA has established a Genomic Medicine Program Advisory Committee (GMPAC) comprised of the nation’s leading clinicians, scientists, administrators, as well as veteran representatives. The committee has recommended the establishment of several working groups. It has also discussed issues such as who should have access to data generated by this program, assessment of veterans’ attitudes towards genomic medicine, and establishing veterans’ trust.
An Ethics Advisory Working Group, which will report through the GMPAC, has also been established. Members of this working group include bioethicists, a member of the clergy, and veterans. The first meeting of this group was in May 2007. Topics of discussion included the ethics of the informed consent document, special populations (e.g., those with mental illness), and the role of group vs. one-on-one discussions for educating veterans about the program.
In addition, last week VA held the first meeting of its PTSD Genetics Working Group to explore and define a research program to identify the genes that are important in how an individual responds to the experience of deployment, especially their response following combat exposure. By carefully characterizing those affected by combat-related PTSD and conducting genetic analyses, VA will be in a position to identify genetic variants that contribute to PTSD and other post-deployment adjustment disorders such as major depression. Once this program is established, this resource will be available for continued research including studying the genetic relationship to treatment response.
Promoting good health and managing chronic conditions remain high priorities for VA health care and VA research, especially in the aging veteran population. The following are examples of efforts by VA investigators to discover how to prevent and treat chronic diseases.
Nearly a quarter of the veterans receiving care from VA have diabetes, and a far greater number (73 percent) are at risk due to overweight or obesity. VA researchers are studying innovative strategies and technologies—including group visits, telemedicine, peer counseling, and Internet-based education and case management—to improve access to effective diabetes care and outcomes. In addition, VA investigators have initiated studies to identify and define the impact of traditional rehabilitation treatment for veterans who have diabetes, and to develop innovative treatments to prevent and improve diabetes outcomes in special populations such as the elderly, amputees, minorities, and spinal cord injured veterans. VA is also supporting major clinical trials on treating kidney disease and coronary artery disease in diabetic patients.
It has been long known that type 2 diabetes runs in families and that certain populations are at a higher risk than others (e.g., Hispanic veterans and American Indian veterans). However, it was not until the recent advances in genetic technologies that researchers began to investigate associations between specific genes and diabetes.
VA investigators have been honing in on genes that boost the risk for type 2 diabetes and obesity. Working with Mexican-American families enrolled in the Veterans Administration Genetic Epidemiology Study, VA investigators have compared small differences in the DNA of people with and without the disease. Earlier work by members of the group had suggested that a specific region of chromosome 6 was involved. This region contained several hundred genes, and initially it was not clear which gene played a role in causing disease. But using recent advances in genome-sequencing, the researchers have combed through the region and narrowed their search to seven genes. The precise functions of these genes are still unknown. Two are involved in metabolic pathways not previously connected with diabetes or obesity. The remaining five appear to be “master regulators” that can alter the expression of hundreds of other genes. Ongoing research is aimed at determining how these genes raise the risk of diabetes and obesity.
The VA patient population, like that of the U.S. in general, is experiencing an epidemic of overweight and obesity. In terms of treatment options, recent findings from VA investigators indicate that surgical treatment is more effective than diet and medications for weight loss in severely obese patients. Weight loss was maintained for up to 10 years or longer, and it was accompanied by significant improvements in diabetes, hypertension, and high cholesterol (Annals of Internal Medicine. 2005; 142(7):547–559; Annals of Internal Medicine. 2005; 142(7):532–546).
Ongoing VA studies are seeking to identify and define the impact of traditional rehabilitation treatment for overweight and obese veterans, and also to develop unique treatment measures to prevent and improve obesity outcomes. In addition, VA researchers are investigating the influence of obesity on the quality of care that veteran patients receive. VA investigators are also focusing on unique populations at risk for obesity, such as patients with spinal cord injury.
- Human immunodeficiency virus/Acquired immune deficiency syndrome (HIV/AIDS)
VA is the largest single provider of HIV care in the U.S., with nearly 20,000 patients with the disorder treated annually. Accordingly, VA 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.
VA investigators recently showed that people with a below-average number of copies of a particular immune-response gene have a greater likelihood of acquiring HIV and, once infected, of progressing to full-blown AIDS. Researchers examined blood samples from 4,308 HIV-positive and HIV-negative volunteers of various geographical ancestries. Depending on the study sub-population, each copy of the gene CCL3L1 decreased the risk of HIV infection by 4.5 to 10.5 percent. These findings, cited as one of the top articles published in the eminent journal Science in 2005, have important implications for the treatment and prevention of HIV infection and AIDS, and possibly other infectious diseases as well (Science. 2005; 307:1434–1440).
The same group has gone on to show that a person’s genetic makeup—in this case, the genes CCL3L1 and CCR5—could be a more accurate predictor of disease progression than currently used laboratory markers, such as CD4+ T cell counts and viral loads. The researchers also demonstrated that the combination of laboratory and genetic markers captures a broader spectrum of AIDS risk than either set of markers alone (Journal of Immunology. 2007; 178:5668–5681).
- Heart Disease
Heart failure is the most common diagnosis causing hospitalization of veterans, with resulting high costs and resource utilization over time. VA researchers recently found that the use of an implanted defibrillator reduced the risk of dying and improved quality of life for veterans with heart failure (Journal of the American College of Cardiology. 2005; 45(9):1474–1481). VA researchers are also studying non-invasive care for heart failure. In addition, nurse researchers are preparing to link biochemical markers of heart failure with patterns of depression to aid in earlier screening and treatment for depression in patients with heart failure. Nurse researchers are also exploring the role patients can play in their own heart failure care.
Coronary artery disease, a narrowing of the arteries that supply blood to the heart muscle, is the leading cause of death in both men and women. More than half a million Americans die each year from coronary artery disease.
A U.S.-Canadian trial sponsored in part by VA’s Cooperative Studies Program found that balloon angioplasty plus stenting did little to improve outcomes for patients with stable coronary artery disease who also received optimal drug therapy and underwent lifestyle changes. The researchers concluded that if a patient with heart disease is doing well on medical therapy alone, there is no added preventive benefit to angioplasty and stenting (New England Journal of Medicine. 2007; 356:1503–1516).
Access to Care.
VA has a prominent and unique role in meeting the health care needs of veterans and ensuring equitable access to quality care for the most recent veterans, veterans from previous service eras, vulnerable populations who rely on VA for health care, and future veterans. The VA health care system continues to strengthen efforts to improve health care to veterans by identifying barriers to care and assessing and implementing system improvements to improve access to quality care. VA research supports and guides these system improvements through a diverse range of studies that analyze factors and interventions impacting access to the VA health care system. VA research identifies system-wide gaps in care to veterans; assesses specific access issues and barriers to care for special populations; assesses the impact of new programs, practice structures, and organizations of care on access and quality of care; and develops and evaluates the impact of quality improvement efforts, organizational and management interventions, implementation initiatives, and new technologies on improved access and health care to veterans.
Over the past decade, VA has added to the number of Community-Based Outpatient Clinics (CBOCs) to increase access to primary care for veterans. CBOCs have been an integral part of VA’s transition from an inpatient-oriented system to an outpatient-oriented system. A VA study compared inpatient and outpatient utilization and expenditures of veterans seeking primary care in 108 CBOCs and 72 affiliated VAMCs in fiscal years 2000 and 2001. Findings show that CBOCs provided veterans with improved access to primary care and other services, but costs were contained because they had fewer health care visits and hospital stays than veterans receiving care at VAMCs. These results held even after adjusting for demographics, patient risk, and distance from care. CBOC patients had significantly lower odds of having specialty, mental health, or ancillary (e.g., radiology, laboratory, other outpatient) visits than VAMC patients. CBOC patients also were less likely to be hospitalized (BioMed Central Health Services Research; 7(1):56).
Evidence-based practices designed for large urban clinics are not necessarily transportable into small rural practices. Implementing collaborative care for depression in small rural primary care clinics presents unique challenges because often on-site mental health specialists cannot be hired. The Telemedicine-Enhanced Antidepressant Management (TEAM) study evaluated a collaborative care model adapted for small rural VA CBOCs using telemedicine technologies (interactive video equipment for mental health and no on-site psychiatrists/psychologists). Participants in the intervention had better medication adherence, were more likely to respond to treatment, and were more likely to experience a remission than those with usual care. Patients also had better quality of life and higher satisfaction. These findings suggest that collaborative care models can be successfully adapted using telemedicine to address rural disparities (General Hospital Psychiatry. 2006; 28(1):18-26; Psychiatric Services. 2006; 57(12):1731-7).
In addition, VA is beginning a new access to care research initiative for OEF/OIF veterans that will build on the body of VA research examining access to care issues and innovations. This research is expected to enhance OEF/OIF veterans’ access to practices that improve well-being and function after physical injury sustained in war, that mitigate suffering due to chronic medical conditions, and that are effective for the treatment needed by veterans returning from the wars in Iraq and Afghanistan. It is hoped that VA’s OEF/OIF access research initiative will help facilitate improved access to care for eligible veterans and more efficient and effective systems of care that meet the health care needs of the OEF/OIF veteran population.
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 reach 1.3 million by 2012. In addition, a younger population of veterans with different long-term and care coordination needs is emerging as a result of the OEF/OIF 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 assistance. Caregiving can also 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 has initiated several efforts to understand and support the needs of caregivers. These include special efforts to survey the needs of caregivers of blast injury and TBI patients, as well as a research initiative focused on developing new approaches to community-based long-term care.
In addition, VA is funding several projects to assess the effectiveness of telemedicine technologies for rehabilitation of veterans who are older, disabled, and/or in difficult to reach, rural areas as compared to home visits by health care personnel and usual care. Tele-rehabilitation may be particularly useful for older and disabled veterans with long-term care needs because it empowers them to take responsibility for their own health by providing ongoing communication with the VA health care system and may allow them to remain independent in their homes as long as possible.
In response to the increasing number of women veterans, documented expansion of the number of women in the military, and special health care needs of female veterans, VA has focused additional attention on women’s health research. VA research efforts are aimed at better understanding the general health care needs and service utilization of women veterans; examining the unique experiences of women veterans regarding risks, treatment, and health care outcomes related to military traumas; and assessing VA’s organization of care for women veterans and the implications for improved quality of care.
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.
In the largest randomized clinical trial to date involving women veterans with PTSD, VA investigators and colleagues found that prolonged-exposure therapy—a type of cognitive behavioral therapy—was effective in reducing PTSD symptoms and that such reductions remained stable over time. Women who received prolonged-exposure therapy—in which therapists helped them recall their trauma memories under safe, controlled conditions—had greater reductions of PTSD symptoms than women who received only emotional support and counseling focused on current problems (Journal of the American Medical Association. 2007;297(8):820–830). Together with a strong mental health research program, VA research is well positioned to continue to enhance health care for women veterans.
Because more than 70 percent of VA researchers are also clinicians caring for veterans, VA is uniquely positioned to move scientific discoveries from investigators’ laboratories into 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 youngest soldier who returns with injuries from recent conflicts to the aging veteran, and to use research findings proactively to benefit the future veteran. VA takes great pride in the research that keeps it at the forefront of modern medicine and health care and expects to see further remarkable discoveries in the coming decades.
Mr. Chairman, that concludes my statement. I am pleased to respond to any questions you or the Subcommittee members may have.