The Obama administration’s push to sign up one million Americans for a long-term health study will start in New York, Pittsburgh, Chicago, and Tucson, AZ, top health officials said today.
National Institutes of Health director Francis Collins (pictured) and FDA commissioner Rob Califf spoke on a call this afternoon to update the Precision Medicine Initiative, or PMI, which President Obama unveiled in early 2015.
The overarching goal is to spur treatments of individuals and health practices based on a deeper understanding of how their individual genes, proteins, and cells interact with their habits and environment. “In medicine, ‘one size fits all’ is often far from an optimal strategy,” Collins said.
The government’s vision dovetails with many in the health field who are already running long-term studies and analyzing, or preparing to analyze, massive amounts of data. The federal initiative is expected to generate a trove of health information, to be gathered from what Collins called “a rich diversity” of volunteers across the country.
Collins said it would take at least three or four years to recruit one million people, with plans to follow them for years after that. Some participants would be recruited through community health centers, and some would be added through healthcare plans or other long-term studies already underway.
To kickstart recruitment, the NIH is initially handing out $55 million in grants. Columbia University in New York, The University of Pittsburgh (PA), Northwestern University near Chicago, and the University of Arizona, in Tucson, will work with local hospitals. The money will also help with outreach at community health centers in six cities, including Knoxville, TN, and San Ysidro, CA—part of the administration’s goal of enrolling people across economic strata. And the NIH will work with the Department of Veterans Affairs to open the PMI to veterans. (The VA is running its own long-term study with nearly half a million participants so far.)
In addition to people sharing blood and tissue samples—which will be housed in a biobank run by the Mayo Clinic—the NIH wants to open the study to people who share personal information and health information, perhaps transmitted via wearable devices. A center led by the Scripps Research Institute in San Diego will work on ways for those individuals to participate.
If all goes well, the first participants could sign up in November. “We’re curious to know whether we’ll be deluged or have to work harder to get the word out,” said Collins.
To coordinate all the data, a center run by Vanderbilt University, Verily (formerly known as Google Life Sciences), and the Broad Institute will build the infrastructure. One goal is for the information to be two-way: Collins emphasized that participants in the study should have access to their own data and to the study results.
For its part, the FDA is taking steps to change the way it regulates next-generation genomic sequencing. Califf announced what he called a new “streamlined” approach to its oversight of the field. Part of the proposed changes will let test makers use public stores of data, such as this one dedicated to genetic variations, to speed up the development of new products. The FDA is releasing drafts of its proposed changes for three months of public comment.
While Collins said PMI participants should have “swift” access to their data, he did not specifically address whether they should be able to benefit financially if, say, researchers use the study’s database to create new medicines or diagnostics. (He and Califf did, however, appeal to the “patriotism” of reporters on the call, asking them to sign up for the study.)
But the question not only of sharing data but also sharing revenues will only become more relevant. Just as tech companies now traffic in user data, for-profit entities such as 23andMe, Helix, Arivale, and Invitae are basing parts or all of their business on personal health data.
For example, 23andMe, which sells “spit kits” that give people a look at their genetic ancestry or potential for passing along certain diseases, also shares aggregated customer data with drug companies for a fee. 23andMe also plans to develop drugs on its own using insights gleaned from those data.
Randy Scott, the CEO of San Francisco genetic testing firm Invitae (NASDAQ: NVTA), told Xconomy last year he also wants to repackage and sell customer data. In doing so, however, he said he would offer customers a slice of the revenues, saying it would give him a competitive advantage. “If… every time an advertiser was pinging you on a social network, the network made money and you also got a piece of the action, would you still stay in a network where they’re taking your private information and making money off you?”