VA’s Million Veteran Program (MVP) holds the potential for revolutionizing the way research is conducted and medicine practiced. Launched in May 2011, MVP will result in a mega database of genetic, health, lifestyle, and military exposure data that helps researchers better address conditions specifically affecting veterans (such as post-traumatic stress disorder and traumatic brain injury) as well as more common chronic illnesses affecting the general population (e.g., heart disease, diabetes). It also will bring us closer to realizing personalized medicine – an approach that helps us better understand why some individuals develop certain conditions and diseases, and others do not; aid in the early detection of post-deployment health issues; and lead to customized treatments.
Further, MVP exemplifies what makes the VA research program unique among other federal research programs: it’s veteran-centric, it’s closely aligned with the Veterans Health Administration (VHA) healthcare system, and it draws upon the VA research program’s substantial track record conducting large, multisite clinical trials.
It also will bring us closer to realizing personalized medicine – an approach that helps us better understand why some individuals develop certain conditions and diseases, and others do not; aid in the early detection of post-deployment health issues; and lead to customized treatments.
What is meant by “veteran-centric”? It means that VA research studies focus entirely on veterans’ healthcare needs, and that we partner with veterans during many study aspects; from learning directly about their specific healthcare concerns to enrolling them as (volunteer) study participants. In fact, none of the VA research program’s numerous breakthroughs and discoveries would have been possible without our veteran volunteers.
For MVP, our partnership with veterans began well before the initiative’s launch. As a first and fundamental step, we engaged in extensive consultations with key Veterans Service Organizations and directly solicited veterans’ opinions regarding genomic research via focus groups. VA also commissioned a survey of veterans’ attitudes regarding genomics, research, and privacy issues that was conducted by the Genetics and Public Policy Center of Johns Hopkins University. As noted in the interview opening this section, 83 percent of respondents endorsed the program. Further, 71 percent indicated they’d participate in MVP, and 84 percent said they thought the database would lead to better treatments.
As this commentary goes to press, more than 200,000 veterans have enrolled in MVP, making it the largest single study ever conducted by the VA research program. As such, MVP is also an outstanding example of the highly altruistic nature of the veteran population: They regard study participation as another form of service. They know that their participation in a given study may not directly benefit their health or health condition, but will improve the lives of others. As VA Secretary Eric K. Shinseki observed when MVP enrolled its 100,000th volunteer in late 2012, “Veterans nationwide are helping to create a database that has the potential to help millions around the country – veteran and non-veteran alike. They are continuing to serve the nation well beyond the time they stopped wearing the uniform.”
It is also important to note that protecting veteran privacy and confidentiality in MVP – like all VA research studies – is paramount, and numerous mechanisms have been implemented to safeguard MVP enrollees’ personal information. First, veterans’ samples and data are stored in a secure, state-of-the-art biorepository with restricted access. The only information that appears on the label is a code, and only a few authorized VA personnel have access to the code’s link. (Even the researchers approved to analyze this information do not receive the name, address, date of birth, and social security number of participating veterans.) Second, veterans’ data are stored behind the VA firewall in a secure database called GenISIS (Genomic Information System for Integrative Science). The only way for researchers to analyze the data is within the GenISIS environment (in other words, the data will not be sent to them outside the firewall).
Additionally, the program’s alignment with VHA patient care means the ability to access (with an MVP enrollee’s signed permission) the VA electronic healthcare record, which provides a long-term picture of a patient’s care over time.
Managing an initiative like MVP, whose scope and implications are both far-reaching, requires an exceptional blend of experience, infrastructure, and expertise. VA is uniquely qualified to lead MVP, and for many reasons. For more than 85 years, VA has been conducting research that improves veterans’ lives. VA conducted the first ever large-scale clinical trial for evaluating treating tuberculosis. This in turn led to establishment of the VA’s Cooperative Studies Program (CSP), which today is responsible for the planning and conduct of large multicenter clinical trials and epidemiological studies.
Further (and as I mentioned during the interview), the VA research program is embedded within one of the nation’s largest healthcare systems, VHA. More than 60 percent of VA researchers are clinicians who care for – and thereby directly hear from – patients about their healthcare needs. Additionally, the VHA patient population constitutes a diverse group, including a growing number of women veterans. Additionally, the program’s alignment with VHA patient care means the ability to access (with an MVP enrollee’s signed permission) the VA electronic healthcare record, which provides a long-term picture of a patient’s care over time.
Why is this important? The relationships between genes, lifestyle, environment, and other factors change over time. Researchers must therefore have the means to follow a veteran’s health history over many years. In other words, for MVP to generate the types of findings that will help improve healthcare, researchers must be able to study these relationships over time. The VA electronic health record, which has now been in place for 15 years, contains information from the first day that a veteran receives healthcare from VA. This is one of the unique characteristics that sets MVP apart from other large database efforts studying genomic information. (It is also the reason why only veterans receiving their healthcare from VHA can participate in MVP.)
With MVP, VA not only aspires to an even higher level of healthcare for our nation’s veterans, but leads the way toward personalized medicine and does so by examining the diseases that veterans have. Veterans can learn more about the program by contacting their local VA medical center. From there, veterans will be asked to complete surveys on health, health-related behavior, and military exposure, and provide a blood sample. Finally, veterans who consent to participate allow (secure) access to VA and VA-linked medical and health information (past and future). Enrollment sites are listed at www.research.va.gov/mvp along the right-hand margin.
Dr. Joel Kupersmith is the former Chief Research and Development Officer (CRADO) for the Veterans Health Administration (VHA), U.S. Department of Veterans Affairs (VA), and is now the CEO of Kupersmith Associates, a medical research and healthcare consulting firm.
This article first appeared in the The Year in Veterans Affairs & Military Medicine 2013-2014 Edition