How VA’s Million Veteran Program is supporting the precision medicine movement

April 25, 2016 Dr. David Shulkin

Bloomberg Government regularly publishes insights, opinion and best practices from our community of senior leaders and decision-makers. This column is written by Dr. David Shulkin, Under Secretary for Health at the U.S. Department of Veterans Affairs. Dr. Shulkin will speak at Bloomberg Government’s Building the Big Data Economy: Personalized Care and Cancer Treatment In the Age of Big Data on April 26. 

This fall, the Department of Veterans Affairs expects to mark a major milestone in our effort to collect DNA and health data from 1 million Veterans when we enroll the 500,000th volunteer in our Million Veteran Program, making it one of the world’s largest genomic cohorts. We expect to reach our enrollment goal in the next few years.

This program’s database links genetic, clinical, lifestyle, and military-exposure information from our patients to help researchers learn more about the role of genes in health and disease. It is already enabling innovative research on the genomics of PTSD, chronic kidney disease, multi-substance abuse and more.

MVP will yield new knowledge about which genes put people at risk for certain diseases, and which ones affect how people respond to treatment. This knowledge could eventually lead to better ways of treating and even preventing many common diseases, including cancer.

Veterans who volunteer to partner with us in this program enroll at one of 50 VA medical centers across the country by donating blood—from which DNA is extracted—and completing surveys about their health, lifestyle, and military experiences.

They also grant access to their electronic health records, and agree to be contacted about participating in future research. We keep all genetic information and health data collected from Veterans secure and de-identified. Samples and data are coded, with no names, birthdates, or social security numbers shared.

The blood samples are processed at a state-of-the-art, robotic-enabled biorepository that processes about 100,000 blood samples a year and sends out DNA for genomic analysis. Our Genomic Information System for Integrated Science (GenISIS) monitors enrollment, serves as the data warehouse, and provides a secure scientific environment for research. Our Veterans Informatics and Computing Infrastructure (VINCI) serves up the electronic health record data for research.

Veterans view enrollment in MVP as an opportunity to continue their service and help other Veterans. And now, MVP is playing an important role in the federal government’s Precision Medicine Initiative and National Cancer Moonshot Initiative, which will give these Veterans an opportunity to help not only their fellow Veterans, but all Americans.

Precision medicine has the greatest potential to transform the way we diagnose, treat, and prevent cancer. About 32 percent of the more than 472,000 Veterans currently enrolled in MVP have reported a cancer diagnosis, and that data offers researchers a potentially rich resource for genetic exploration and analysis.

We’re working with the Department of Defense and National Institutes of Health to develop interagency agreements that will allow us to collaborate and share data. The agreement with DoD would enable us to enroll active duty service members in MVP, while the agreement with NIH would enable enrollment of Veterans in the Precision Medicine Initiative Cohort Program.

VA’s Precision Oncology Program is paving the way for incorporating the results of genetic diagnostic testing to customize medical decision making and treatment for individual cancer patients. This program is based in Boston and is supported by the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC).

Through our Cooperative Studies Program, we conduct multi-center clinical trials using the electronic health records shared among all VA medical centers. One study set the standard for early colorectal cancer screening by showing the efficacy of colonoscopy over sigmoidoscopy. Another study now underway is comparing colonoscopy with fecal immunochemical testing in colorectal cancer screening. Other studies are underway for prostate, skin and lung cancers.

The goal of precision medicine is to develop the knowledge that allows us to deliver the right treatment to the right patient at the right time. Today, if you have cancer, your oncologist might recommend a treatment for you based on clinical studies that could involve several hundred or even thousands of patients.

It’s a good bet that most of those patients aren’t like you—they may differ in age, race, gender, lifestyle, or genetic makeup. They may also differ in what is most important to them. For instance, living as long as possible may be most important to some, while for others it may be maintaining quality of life through treatment.

Big data refers to the ability to combine clinical and genetic data across hospitals and health systems so we can learn not from the few thousand patients who receive treatment in a clinical trial, but from the tens or hundreds of thousands who receive that treatment in regular care. That will allow us to determine what works best for whom.

VA research has long been distinguished by the fact that our patients are eager to help their fellow Veterans by volunteering for studies. Their altruism, combined with the lifelong care we provide and a standard electronic health record system, make VA an ideal partner in the precision medicine movement. We’re committed to making precision medicine a reality for Veterans and all Americans.

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