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National Journal: Can the Information Age Deliver Medical Marvels? Congress Just Bet $200 Million It Can.

January 4, 2016
News Stories

National Journal - Rachel Roubein

Wristbands that track your daily activity. Kits that can purportedly analyze your genetics. Smartphone apps that track your daily intake of protein, sugar, and carbs.

It’s the age of “precision medicine,” as doctors and patients look to leverage vast amounts of individualized information available to fight diseases in a way they’ve never been able to before—with treatments that take into account environment, life-style, and even genes.

At least, that’s what the approach’s proponents have said they could deliver with the research support of the federal government.

The more than $1.1 trillion budget deal gave full funding to the National Institutes of Health for President Obama’s Precision Medicine Initiative. Congress appropriated $200 million for NIH ($70 million for the National Cancer Institute and $130 million to build a research cohort program).

A core part of the program involves recruiting volunteers to submit genetic data, biological samples, and information about their diet and lifestyle over the course of many years with the overall goal of expanding precision medicine to many diseases.

The funding comes after a year of uncertainty, starting on Jan. 20, when Obama announced his Precision Medicine Initiative in the State of the Union in just a few sentences:

“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time,” Obama said. “In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. So tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

Even before the State of the Union, Rep. Tom Cole—the newly appointed head of the subcommittee overseeing NIH’s budget—was gearing up for a tour of the NIH facility. Cole says he arrived before other members for a quick briefing with NIH Director Francis Collins on the soon-to-be-unveiled initiative.

It wasn’t hard to get on board with precision medicine, the Oklahoma Republican said in an interview. Among many proposed advancements, the initiative aims to help chronically ill Americans in a way that officials say they hope could reduce medical costs. This is something Cole says his party can support, as evidenced in the recently passed spending bill, which ended almost a year of relative uncertainty for the initiat-ive’s future and gave NIH the money needed to rev the program into high gear in 2016.

(NIH confirmed Cole’s visit on the day of the State of the Union, and said that while the conversation between Collins and Cole was confidential, NIH aims to give the Hill a heads-up on upcoming issues.)

The new appropriation comes as a relief for Collins. The initiative has two major parts: The National Cancer Institute (a part of NIH) will accelerate America’s knowledge of cancer genomics, and NIH will establish a cohort of a million or more people to submit their health information and participate in a national study of health. By the end of 2016, NIH hopes to have about 75,000 Americans signed up for the Precision Medicine Initiative Cohort Program, Collins said in an interview. (The overall goal of at least 1 million volunteers will likely take three or four years.)

Obama’s fiscal 2016 budget made clear what this would cost: $200 million would go to the NIH, $10 million to the Food and Drug Administration, and $5 million to the Office of the National Coordinator for Health Information Technology.

Initially, both the House and Senate seemed on board with funding the initiative, but when budget talks stalled, it appeared possible that Congress would opt for a continu-ing resolution—one that would provide no additional funding for precision medicine.

Meanwhile, NIH proceeded with planning, working to have the program ready to kick off in 2016 if Congress came through with the cash for it. Had NIH waited, Collins said, the cohort program wouldn’t have been ready in 2016.

“We’ve kind of been holding our breath but going full-speed ahead under the assump-tion that the dollars would be there,” Collins said in an interview.

At a Senate Appropriations subcommittee hearing in October, Collins voiced his con-cerns about what would happen if a new spending bill wasn’t passed: “A yearlong CR … would be simply devastating,” he said. “The Precision Medicine Initiative, for in-stance, would basically have to go into the freezer or on mothballs or whatever the appropriate discouraging metaphor would be. We would just be at the point of start-ing this effort to enroll a million Americans in this unprecedented study and carry out exciting new studies in cancer genomics, and those would basically have to go on hold, and that would be enormously disappointing.”

But in the end, Congress reached its deal, and now NIH will continue to prepare for the launch of the cohort program. By late summer, enrollment is expected to begin. And by the end of 2016, that’s when Collins hopes to have about 75,000 Americans signed up.

Beyond fiscal 2016, Cole said he hopes this year’s increase to NIH is the start of more to come. The congressman wants to give the agency a sense of stability, to know that Congress is invested in NIH’s work. “Precision medicine is one of the areas that we think is really promising in terms of being able to deliver tremendous medical break-throughs,” he said.

The White House is already touting how precision medicine has benefited a select number of Americans, offering a glimpse of what could happen if these cases of using advanced genetic information became the norm for treating all illnesses.

Beatrice Rienhoff’s father, a clinical geneticist, helped identify a variant responsible for the weakness of his daughter’s leg muscles and the fact that she couldn’t gain weight. Melanie Nix’s doctors found a gene mutation that led to the discovery that she had an aggressive form of breast cancer and that a bilateral mastectomy was her best option. And at 6 years old, according to the White House’s website, Emily Whitehead became leukemia-free after enrolling in an immunotherapy trial that collected and reengineered her own T cells.

Online: National Journal