HOUSE COMMITTEE ON VETERANS’ AFFAIRS
MAY 5, 2010
STATEMENT OF JOEL KUPERSMITH, M.D.
CHIEF RESEARCH AND DEVELOPMENT OFFICER,
VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS
May 5, 2010
Mr. Chairman, Mr. Ranking Member, and Members of the Committee: Thank you for the opportunity to appear today to discuss the Department of Veterans Affairs’ (VA) progress in conducting the National Vietnam Veterans Longitudinal Study (NVVLS) and the illnesses associated with exposure to Agent Orange. I am accompanied by Victoria Anne Cassano, MD, MPH, Director, Radiation and Physical Exposures; and Acting Director, Environmental Agents Service, VHA. My testimony today will discuss the history of the NVVLS, VA’s current plans for a comprehensive, longitudinal study of Vietnam Veterans, other research relevant to Vietnam Veterans, and our health care programs specifically tailored to the needs of Vietnam Veterans.
History of the National Vietnam Veterans Longitudinal Study
In 1983, Congress mandated that VA conduct a study on post-war psychological problems among Vietnam Veterans. VA contracted with an external entity, the Research Triangle Institute, to conduct the National Vietnam Veterans Readjustment Study (NVVRS). The study, completed in 1988, provided an extensive report of disabilities, including post-traumatic stress disorder (PTSD), in Vietnam-era Veterans, and is considered to be a landmark study of PTSD and its consequences in Vietnam Veterans. Based on the diagnostic approach used in the study, it was determined that 15 percent of male Vietnam Veterans experienced PTSD within the previous 6 months and an estimated 31 percent would experience PTSD during their lifetime. Prevalence rates for PTSD in female Vietnam Veterans were similar but somewhat lower. Subsequent reanalysis of the original NVVRS data by other scientists has estimated a somewhat lower prevalence of PTSD that is more in line with other studies of PTSD in Vietnam Veterans.
In 2000, Congress passed and the President signed the Veterans Benefits and Health Care Improvement Act of 2000, which became Public Law (P.L.) 106-419. Section 212 of this legislation directed VA to contract for a follow-up study of Vietnam Veterans in the original 1988 NVVRS. In 2001, VA entered into a contract with the same contractor for a follow-up called the National Vietnam Veterans Longitudinal Study (NVVLS). However, delays, escalating costs, and concerns about contracting practices prompted suspension of the study and cancellation of the contract before data collection began. A VA Office of Inspector General (OIG) audit report, released September 30, 2005, confirmed ineffective planning, contracting, and project management.
In 2008, the Senate Appropriations Committee included a requirement in Senate Report 110-428 directing VA to fulfill the requirements of section 212 of P.L. 106-419. In January 2009, VA informed the Chairs and Ranking Members of the House and Senate Veterans’ Affairs and Appropriations Committees of concerns that the NVVLS approach would not adequately or substantively address questions about the mental or physical health status of the Vietnam Veteran population or about the course and consequence of PTSD. VA had, in the interim, initiated a broad portfolio of scientifically rigorous studies dedicated to addressing the needs of the Vietnam Veteran population and offered two of these as alternatives to restarting the NVVLS. Specifically the Department has funded several major research efforts, including a longitudinal follow-up study entitled, “A Twin Study of the Course and Consequences of Post Traumatic Stress Disorder (PTSD) in the Vietnam Era Veterans,” based upon the well-studied Vietnam Era Twins Registry (VET-R), together with a second study, “Determining the Physical and Mental Health Status of Women Vietnam Veterans.”
The House Committee on Veterans’ Affairs concluded in June 2009 that these two studies did not adequately address the law and directed that NVVLS be completed. In September 2009, the Secretary of Veterans Affairs announced that the agency planned to award a contract to an external entity to conduct the NVVLS.
Current Plans for NVVLS
VA understands that Veterans and Congress are still concerned about the long-term effects of military service in Vietnam; VA shares that concern as well. This is why VA continues to support programs and efforts addressing the needs of the Vietnam Veteran population. VA also has reinstituted the process to contract for the completion of NVVLS, paying close attention to prior OIG recommendations and the intent of P.L. 106-419. VA’s Office of Research and Development (ORD) is managing the project and has completed a number of necessary steps.
Specifically, in September 2009, VA convened a scientific panel and other experts (legal, administrative and contracting) as part of an Integrated Project Team (IPT) to develop requirements for the NVVLS. The Scientific Panel consisted of subject matter experts from within and outside of VA. This Panel was asked to establish the scientific requirements and propose a valid approach to serve as the basis for the contract. They identified several challenges to reopening the NVVLS:
The data from the initial contractor regarding NVVRS must be transferred safely and securely to the new contractor for NVVLS.
There may be difficulties in getting the original cohort of Veterans to participate in the new NVVLS. Of those not already enrolled in the VA system, it is not known how many would be located and agree to participate in a new study, or even how many are still alive. Thus it is unclear if the sample size will be large enough to yield statistically significant findings, particularly for questions involving subgroups.
Methods for diagnosing PTSD have evolved over the 25 years since the NVVRS. The design of the NVVLS will need to strike a balance between repeating methodologies using in NVVRS, for the sake of longitudinal consistency, and incorporation of new diagnostic strategies for contemporary validity.
The NVVRS was not designed to accommodate a follow-up study and there is a potential for statistical bias that the contractor will need to consider.
As part of re-opening the NVVLS, the IPT also developed a Performance Work Statement and Acquisition Package during 2009. In early March 2010, the IPT forwarded the Package to the VA Contract Review Board. This Package contains:
A Performance Work Statement, which describes the background of NVVLS, public law mandates, the study objectives, the specific mandatory tasks (organized by study phase) and associated deliverables, and VA security and data use and ownership requirements;
An Acquisition Plan, which describes the statement of need, schedule constraints, current estimated cost, desired capability of offers, risks, plan of action, and milestones. The plan of action also describes the evaluation factors for source selection;
An Independent Government Cost Estimate, which describes the methodology and assumptions in calculating the best estimate of the cost of the contract;
A Market Research Report, which describes the outcome of market analysis, including a request for information along with online searches for capabilities of potential offers under social-economic considerations; and
A certificate of a potential Contract Officer Technical Representative (COTR).
Once the Acquisition Package has been approved, VA will solicit bids and evaluate proposals; we expect this will be completed this summer. VA will then award the contract and begin the study in the early fall. VA has established a project management structure to ensure: the project reaches its objectives; a COTR in ORD will monitor the contractor’s performance and ensure that the contractor adheres to study performance requirements, cost, reporting schedule, and timeliness; and reports any unexpected events in the course of the study. The IPT has determined milestones for the study and the COTR will use performance metrics to monitor progress.
Between 2011 and 2013, the awarded contractor will obtain Institutional Review Board (IRB) and Office of Management and Budget (OMB) approvals for the project and initiate the study under VA monitoring. By 2014, the data should be available for analysis and we anticipate the results will be available shortly thereafter for publication in a scientific journal.
The new NVVLS will consist of the following four phases:
Feasibility Phase: Establish how many individuals from the original National Vietnam Veterans Readjustment Study (NVVRS) cohort are available and potentially willing to participate in the NVVLS;
Start-Up Phase: Prepare the assessment and data collection materials, finalize protocol and obtain IRB and OMB approval.
Implementation Phase: Recruit and enroll participants, conduct assessments on all participants.
Close-Out Phase: Analyze data, prepare final reports, and deliver data to VA.
VA is committed to the success of the NVVLS and will continue to keep Congress apprised of any significant developments.
Other Research on Vietnam Veterans
The U.S. Air Force made a commitment to Congress and the White House in 1979 to conduct an epidemiologic study of the military personnel that were likely to have been the most highly exposed U.S. Servicemembers to Agent Orange herbicide in Vietnam, in Operation Ranch Hand missions. The “Ranch Hand” study’s assets include an electronic database and biospecimens such as serum, urine, adipose tissue and semen. These have been maintained and managed by the Medical Follow-Up Agency of the Institute of Medicine of the National Academies (IOM) as directed by P.L. 110-389, the Veterans’ Benefits Improvement Act of 2008. This act authorizes IOM during fiscal years 2009 through 2012 to conduct additional research on the assets to develop a better understanding of the health determinants and wellness promotion among Veterans. The law also requires an IOM report to Congress assessing the feasibility and advisability of conducting additional research on such assets after the end of fiscal year 2012. To accomplish this goal, VA is contracting with IOM; to date, VA has met with IOM and has enlisted the assistance of VA’s Office of General Counsel and a contracting specialist. Ultimately, funds will be transferred from VA to the U.S. Air Force for the maintenance of the biospecimens using a Military Interdepartmental Purchase Request.
VA’s Health Care and Benefits Programs for Vietnam Veterans
In addition to its research portfolio for Vietnam Veterans, VA has a number of health care programs specifically designed for this population. The most notable example of health effects related to military service from Vietnam are the health effects associated with exposure to herbicides such as “Agent Orange.” During the Vietnam War, the U.S. military used more than 19 million gallons of various herbicides for defoliation and crop destruction in the Republic of Vietnam. Veterans who served in Vietnam anytime during the period beginning January 9, 1962, and ending on May 7, 1975, are presumed to have been exposed to herbicides.
VA established the Agent Orange Registry to track the special health concerns of Veterans who may have been exposed to Agent Orange during their military service. This program includes a medical exam that is comprehensive (including exposure and medical histories, laboratory tests, and a physical exam). A VA health professional discusses the results with the Veteran in a face-to-face consultation and a follow-up letter. The exam is cost-free for Veterans and does not require enrollment in VA health care or VA’s benefits programs. Veterans who served in Vietnam or other areas where the herbicide Agent Orange was sprayed are eligible for the Agent Orange Registry examination. Veterans should ask to speak to their Environmental Health Coordinator or Patient Care Advocate at their local VA medical center for information about participating in an Agent Orange Registry health exam. VA also offers an array of resources to providers to inform them of health care concerns and treatment approaches related to Agent Orange exposure. We are currently in the process of updating the Veterans and Agent Orange Veterans Health Initiative (VHI). Now called “Caring for Vietnam Veterans,”this program will cover a range of issues including Agent Orange, infectious diseases, post-traumatic stress disorder (PTSD) and other psychological outcomes, as well as reproductive outcomes specifically related to the Vietnam War.
On March 25, 2010, VA published a proposed regulation to establish presumptions of service connection between exposure to herbicides in Vietnam anytime during the period beginning January 9, 1962, and ending on May 7, 1975, and
Parkinson’s disease, ischemic heart disease (IHD), and all B-Cell leukemias (which include Chronic Lymphocytic Leukemia, previously service connected, and hairy cell leukemia). This decision was based on an analysis of the findings from the Institute of Medicine’s seventh biennial update, “Veterans and Agent Orange: Update 2008.” As a result of this decision, an estimated 86,069 disability claimants who were previously denied benefits for one of those conditions will be eligible to receive retroactive payments for the new presumptive conditions in 2010. An estimated 32,606 Veterans who currently receive compensation for other service-connected conditions will become eligible for prospective benefits based on the new presumptions in 2010, which may increase their disability payments. An estimated 28,934 and 10,416 potential accessions are also expected in the same year for Veterans and survivors, respectively. VA estimates that the total impact on health care costs for this new determination will be $236 million in fiscal year (FY) 2010, $165 million in FY 2011, and $171 million in FY 2012. VA is requesting a supplemental 2010 appropriation of $13.4 billion to provide for the increased disability compensation and survivor benefits.
The new rule will bring the number of categories of illness presumed to be associated with herbicide exposure to 14 and significantly expand the current leukemia definition to include a much broader range of chronic B-cell leukemias beyond Chronic Lymphocytic Leukemia previously recognized by VA. VA has previously recognized a number of other illnesses as presumptively service connected for exposure to herbicides during the Vietnam War, including: AL Amyloidosis, Acute and Subacute Transient Peripheral Neuropathy, Chloracne or other Acneform Diseases consistent with Chloracne, Chronic Lymphocytic Leukemia, Diabetes Mellitus (Type 2), Non-Hodgkin’s Lymphoma, Porphyria Cutanea Tarda, Prostate Cancer, Respiratory Cancers, Soft Tissue Sarcoma (other than Osteosarcoma, Chondrosarcoma, Kaposi’s sarcoma, or Mesothelioma), and spina bifida in the children of exposed veterans. Veterans whose service in Vietnam qualifies them for presumptive service connection of a medical condition do not have to prove they were exposed to Agent Orange to receive VA health care benefits related to Agent Orange exposure. VA operates three War-Related Illness and Injury Study Centers (WRIISC) that provide clinical expertise for Veterans with deployment health concerns or difficult to diagnose illnesses. Any Veteran concerned about their exposure can seek a referral to a WRIISC from their primary care provider.
Mr. Chairman, Vietnam Veterans represent the largest portion of Veterans in terms of service era, and VA will continue to deliver them the quality health care and benefits they deserve. I thank you again for your support of our work in this area, and for the opportunity to appear before you today. I am now prepared to answer your questions.