VA Testimony of JOEL KUPERSMITH before Congress on July 30, 2009

United States Department of Veterans Affairs

STATEMENT FOR THE RECORD
JOEL KUPERSMITH, MD
CHIEF RESEARCH AND DEVELOPMENT OFFICER
VETERANS HEALTH ADMINISTRATION
DEPARTMENT OF VETERANS AFFAIRS
COMMITTEE ON VETERANS’ AFFAIRS
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATION
U.S. HOUSE OF REPRESENTATIVES

July 30, 2009

Thank you for the invitation to discuss the Department of Veterans Affairs’ (VA) research and development program, and specifically its work on Gulf War Veterans’ Illness. I appreciate the opportunity to discuss the vital role VA research has in ensuring the health and well-being of our Nation’s Veterans.

My testimony will provide an overview of VA’s research programs, describe our process for allocating funding based on scientific merit, report on our current allocation of funds for Gulf War Veterans’ Illness research, and describe some of the current challenges and considerations associated with the science involved in this field of study.

Overview of VA Research

For more than 80 years, VA’s Office of Research and Development (ORD) has been improving the lives of Veterans and all Americans through health care discovery and innovation. Because more than 70 percent of VA researchers are also clinicians who provide direct patient care, VA is uniquely positioned to move scientific discovery from investigators’ laboratories to patient care. In turn, VA clinician-investigators identify new research questions for the laboratory at the patient’s bedside, making the research program one of VA’s most effective tools to improve the care of Veterans. Our fundamental goals are to address the needs of the entire Veteran population from the young recruit who returns from combat with injuries to the aging Veteran, and to use research findings proactively to benefit the future Veteran. Data generated by VA researchers are used not only in current projects but also form the foundation for future projects as well.

VA research is an intramural program that is also fully integrated with the larger biomedical research community through VA’s academic affiliations and collaborations with other organizations. VA scientists partner with colleagues and foster dynamic collaborations with other Federal agencies, academic medical centers, nonprofit organizations and private industry nationwide, further expanding the reach and scope of VA research. This is often a channel for new and emerging technologies to be introduced into VA; as devices or equipment are approved by the Food and Drug Administration, VA researchers are among the first to bring them into the mainstream clinical environment, while teaching others how to use them.

While VA research is principally focused on benefiting current and future Veterans, it also impacts Veteran families and caregivers, VA health care providers, Veterans Service Organizations, other components of the Federal research establishment, academic health centers, and practitioners of health care across the country. VA research is a valuable investment with remarkable and lasting returns.

Merit Review Process

VA ensures the best research programs receive funding and support through its merit review process. A VA Office of Research and Development (ORD) program manager with specific subject matter expertise in the proposal’s field reviews each submission and refers it to a Peer Review Committee for evaluation. This Committee is composed of highly qualified and senior scientists with extensive backgrounds without conflicts of interest with the proposals they review. Each member critiques and scores the proposal; funding selections are made based upon this review. If a research proposal is not selected, the Committee’s critique is provided to the researcher so that he or she can develop a better proposal for the future.

Additionally, VA’s Cooperative Studies Program (CSP) within ORD supports research that will be ongoing for several years and involve multiple VA medical centers and patients. To apply for CSP support, study proponents develop a letter of intent; if this letter describes a proposal with strong scientific and clinical significance, the letter is then reviewed by a CSP Study planning group and the five Coordinating Centers that would participate in the research. This group and the Coordinating Centers work with the study proponent to further refine the project and address logistical and scientific issues. A separate reviewing body then considers the proposal to ensure all potential concerns are fully addressed before the study begins.

All studies funded by ORD that involve patients receive the highest level of scrutiny to ensure the safety of the patient and the most certainty that the study will contribute to better health care for Veterans.

Current Allocation of Funds for Gulf War Veterans’ Illness Research

During Fiscal Year (FY) 2008, VA allocated more than $20 million for research related to Gulf War Veteran’s illnesses. This research supports a range of programs and clinical areas, including research into the prevalence of brain cancer among Gulf War Veterans, the prevalence of multiple sclerosis in Gulf War Veterans, and a $15 million per year contract involving the Dallas VA Medical Center and the University of Texas Southwestern Medical Center (UTSW) to support Gulf War research. The UTSW research is investigating multi-symptom illnesses among Gulf War Veterans and the contract is renewable at VA’s discretion on a year-to-year basis until September 30, 2011.

VA-funded epidemiological studies have proven instrumental in identifying the range of chronic symptoms and health problems reported by Gulf War Veterans. This research has found that these symptoms occurred at rates that exceed non-deployed era Veterans and that these symptoms persist. The most common symptoms include impaired cognition, attention, and memory; persistent headaches; diarrhea and gastrointestinal problems; skin rashes; extreme muscle weakness and fatigue; joint pain; and sleep disturbances. VA continues to monitor this population of Veterans for changes in mortality rates and incidence of cancers. In addition to these studies of unexplained symptoms, VA has funded investigations to assess the prevalence of other diseases, such as cancer, amyotrophic lateral sclerosis (ALS), and multiple sclerosis in Gulf War Veterans, since there is some evidence that these diseases may also occur at elevated rates in this population.

In October 2002, April 2004, and March 2005, VA issued a Request for Applications (RFA) to solicit new research projects focused on the long-term health effects of deployment in the Gulf War, the health effects of specific military occupational and environmental exposures, improvements in evaluation, diagnosis and treatment of Gulf War Veterans’ illnesses, prevalence of neurological disorders such as ALS and multiple sclerosis in Gulf War Veterans, and changes in the autonomic nervous system or immune system that may be associated with, or involved in the persistence of, unexplained symptoms or illnesses reported by Gulf War Veterans. VA recently announced a fourth RFA in May 2009 to specifically solicit proposals to study new treatments for ill Gulf War Veterans, including testing treatments that have previously been used for chronic fatigue syndrome and fibromyalgia, two conditions in the VA and general populations with similarities to Gulf War Veterans’ illnesses.

VA continues to support Gulf War Veterans research more broadly, and over the last 15 years, VA has spent almost $130 million on research directly related to Gulf War Veterans. These funds do not include the VA-funded research that may be related to health care concerns of Gulf War Veterans (i.e., ALS, multiple sclerosis, or cancer) but are not solely focused on the Gulf War Veteran population. The Departments of Defense and Health and Human Services have spent more than $235 million over the same time period, for a total of almost $365 million from the Federal government. VA is committed to building on what we have spent and to expand the foundation of available data to find relief for current illnesses while planning for the future. For example, VA is directing research into genomic studies, using state-of-the-art imaging techniques and correlation of tests of brain function, delineation of biomarkers, treatment trials and determinations of autonomic and motor function.

Scientific Challenges and Considerations

VA recognizes there are challenges to establishing scientific bases for clinical determinations about medical conditions associated with military combat. Necessary data are sometimes unavailable, control groups can be difficult to establish, participants may not be easily identified, and the sheer number of potential factors or variables renders a definitive conclusion elusive. However, our charge is to learn as much as we possibly can about those conditions, no matter the obstacles.

Another challenge is a perception by some Veterans that research data will be used to make determinations regarding VA benefits. As an assurance to Veterans, research data from participants has not been used by VA to affect benefits and ORD supports and enforces that policy. Similarly, VA researchers must also consider protections established by law, regulation and policy concerning patient confidentiality. Patient confidentiality is of utmost importance to VA and we take extraordinary steps to protect our Veterans. The Privacy Act and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) restrict how research data may be used. Patients understand that information they provide to a researcher is personal and potentially identifiable, and VA researchers are required to clearly explain this to research participants.

Even very personal information, such as a research participant’s genetic structure, can be protected, and Veterans are often enthusiastic about participating in this type of research. For example, VA research into genomic medicine has included questions asking participants about their feelings about this type of investigation. More than 70 percent of Veterans surveyed reported they would participate in genomic research; more than 80 percent of Veterans reported believing that participation in this research would help other Veterans; and more than 85 percent reported being curious about the influence of their genes on their health. This support for VA’s research program provides VA with critical data and insight, and in turn holds great potential for supporting the care and well-being of all Veterans, including Gulf War Veterans.

Conclusion

In conclusion, VA remains committed to funding scientifically meritorious research projects that improve our understanding of Gulf War Veterans illnesses and enhance our ability to diagnose and treat ill Gulf War Veterans. Moreover, the knowledge we gain from these efforts may improve our ability to prevent and treat illnesses affecting participants of current and future deployments. Your support of VA’s research programs is greatly appreciated and I look forward to your questions.