Until this week, many U.S. government science agencies and programs seemed destined for a big haircut, plus the loss of a limb or two. That included the Precision Medicine Initiative, an ambitious long-term study with the goal of recruiting 1 million Americans to volunteer health data.
But in staving off a government shutdown, Congress pushed back hard against the White House’s funding proposal to cover the rest of the current fiscal year, which runs through September. Nothing’s a done deal until it has President Trump’s signature. But as things stand, the Precision Medicine Initiative, or PMI, could get as much as $230 million for the year, which would be nearly double the initiative’s 2016 budget. Some of that money comes from the 21st Century Cures Act, a wide-ranging law that aims to speed the review of new drugs and devices that President Obama signed just before he left office.
The timing is critical. The initiative is weeks away from recruiting its first volunteer. The goal is to sign up as many as 35,000 people through the fall before pausing to take stock. The NIH’s Eric Dishman, who runs the main part of the PMI, calls it a “beta phase” of recruitment. (Dishman spent 15 years at tech giant Intel before coming to the NIH.)
“If we don’t get above $130 million,” said Dishman, referring to the current budget negotiations, “it would delay significant elements of the program.”
Dishman’s group has lined up major health centers such as Massachusetts General Hospital and the University of Pittsburgh (PA) as well as smaller community centers around the country to help recruit a diverse range of Americans. Diversity, in fact, is paramount. “I’d rather they miss their overall numbers” than fail to recruit a diverse population, said Dishman. The long term goal is to have 75 percent of the volunteers from groups traditionally underrepresented in biomedical research. Extrapolating results from white European men and applying them to women or non-white groups “can cause harm,” said Dishman.
At first, volunteers will answer personal health and history surveys and submit blood and urine samples. Later, perhaps by the end of 2018, said Dishman, could come whole genome sequencing and daily data from participants’ wearable devices.
Both those elements will face cost and technology hurdles, however. The PMI has promised that all participants will have full access to their own data. The infrastructure to share vast amounts of personal information must be secure, and people receiving their own data must have the resources to interpret it. “There currently aren’t enough genetic counselors in the country to support what’s out there,” said Dishman.
The kickoff comes soon after the official launch of a long-term health study run by Verily, formerly known as Google Life Sciences. Verily’s Baseline study is aiming for 10,000 participants who would undergo a much deeper battery of tests that would require a couple days’ visit to a clinic.
“They’re very different strategies,” said Eric Topol, director of the Scripps Translational Science Institute in San Diego, which is building key pieces of the PMI—and who raised questions last year in a Nature paper about tech giants like Apple and Verily’s parent Alphabet gathering health data. (Verily is helping Vanderbilt University and the Broad Institute build the PMI data center, but its Baseline study is completely separate.)
“So much data about any given human has particular value for certain things. Like blood pressure data around the clock for 10,000 people, that’s far more than we have today.” But understanding disease states across diverse groups, such as different ages, or urban versus rural, “you can’t do it with just 10,000 people,” Topol said.
Verily unveiled a wrist-worn “Study Watch” that will record participants’ daily activities and vital signs. Unlike the PMI, Verily is not going to share all the data collects with the participants.
NIH director Francis Collins said last year recruitment for the PMI study, now renamed All of Us, would start in November 2016. That didn’t happen, says Dishman, because the NIH wanted to include urine and blood sample collection right out of the gate. The upcoming beta phase will ensure that the health centers are collecting and shipping samples properly to the study’s biobank run by the Mayo Clinic, he says.
All of Us recruiters, sensitive to people’s attitudes about giving the government personal data, will also report on the outreach methods that work during the beta, and those that don’t, according to Dishman.
Funding for 2018 and beyond is still up in the air. The White House has proposed a “skinny budget” for 2018 that slashes NIH funding 19 percent. With the pushback this week, future drastic cuts seem less likely. Dishman said that for All of Us to expand to 1 million participants in coming years and provide valuable data to researchers, the average budget beyond 2018 should be north of $400 million.
Photo of U.S. Capitol by Kevin Dooley via Creative Commons 2.0 license.