President Details $215 Million 'Precision Medicine Initiative'

The 'precision medicine initiative' will require an initial investment of $215 million and the consent from 1 million volunteers, with the potential goal of discovering cures for patients with cancer, explained President Barack Obama at a White House event held January 30, 2015.

Of the total funds detailed in the President’s 2016 budget request, $70 million will go directly to the National Cancer Institute (NCI), part of National Institutes of Health (NIH), to scale up efforts to identify genomic drivers in cancer and apply that knowledge to the development of more effective approaches to cancer treatment.

“We have the possibility of leading an entirely new era of medicine that makes sure that new jobs and new industries and new lifesaving treatments for diseases are created right here in the United States,” the President said. “We want to use that knowledge to develop new and more effective approaches to help people beat this disease.”

The NIH will specifically receive $130 million to develop a voluntary national research cohort of 1 million or more volunteers for data collection and analysis. Funds from the initiative will also go toward the FDA and the National Coordinator for Health Information Technology (ONC).

“Just like analyzing our DNA teaches us more about who we are than ever before, analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” the President said.

President Obama also mentioned that the administration would work together with the FDA to develop new approaches for evaluating next-generation genetic tests by approving $10 million to acquire additional expertise.

 

“The way we approve a new gene sequencing technology is going to be different than the way we approve a new pacemaker or prosthetic device,” he said.

Additionally, the ONC will receive $5 million to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.

“Because we want every American ultimately to be able to securely access and analyze their own health data so that they can make the best decisions for themselves and for their families,” the President explained. “This has the possibility of not only helping us find new cures, but it also helps us create a genuine healthcare system as opposed to just a disease care system.”

Moreover, investment into genetic research helps stimulate the economy. For every $1 spent on the Human Genome Project so far, $140 is returned to the economy.

“There’s a huge economic stake in us tapping in to this innovation,” the President said. “But as anyone who has watched a loved one battle with an illness, particularly a life-threatening illness . . . the most important impact these investments can have can’t be measured in dollars.”

When Francis S. Collins, MD, PhD, the director of the NIH, sequenced the first human genome, it cost about $100 million. Now, it costs less than $2000, the President said. However, even with costs declining, integrating these tests and results into practice is still going to take time.

Physicians and researchers have realized for some time now that a “one-size-all” approach wasn’t going to work anymore. In the field of cancer, a growing understanding of the disease and accompanying genetic mutations have led to earlier detections and more targeted therapies to treat certain cancers.

“With whole genome or whole exome testing, you can go into the test with one goal in mind, but more information is gathered on other health risks as a result of the test,” Joy Larsen-Haidle, MS, CGC, a genetic counselor at the Humphrey Cancer Center and the President of the National Society of Genetic Counselors, said in an interview with OncLive. “It’s going to be really important for patients to understand what the test is going to tell them, how they’re going to use it in their medical care, and to participate in that informed consent process so that they’re ready to hear that information.”

Several barriers still face the integration of precision medicine. There is a need for family history collection standardization and better utilization of electronic medical records. Additionally, studies have shown that many physicians are uncomfortable with ordering genomic testing because they do not know how to interpret the results.

“[These barriers] highlight the importance of different kinds of providers, such as oncology nurses and physicians and genetic counselors, all working together to make the optimum care plan for the patient,” Larsen-Haidle believes. "From our perspective, if we can get genetic counselors recognized as providers under CMS, that decreases an access barrier for our senior citizens and also for some other patients that are covered by a third-party payer.”