Guess what was the most popular message in President Obama's State of the Union address? Believe it or not, tracking polls showed Obama's announcement of a $215 million precision medicine initiative was the highest-rated statement of the entire speech.
“We couldn’t tell if people were reacting to the idea or to [Obama’s] enthusiasm,” says Duke University patient engagement director Bray Patrick-Lake, who participated on a working group that is helping to shape the initiative. “My experience with this is he is just so passionate and knowledgeable about this, and so engaged.”
The President is also committed to getting the initiative “solidly under way before leaving the White House,” says his Deputy Director for Science, Outreach and Policy Kathy Hudson. For the experts working on this, there is real urgency and clarity of purpose, she says.
Passion and clarity of purpose notwithstanding, there are a lot of ethical, privacy, technological and logistical hurdles to surmount before realizing the promise of precision medicine. Speaking Saturday at the Association of American Medical Colleges’ annual conference in Baltimore, Hudson and Patrick-Lake reported on progress being made on the initiative and development of its foundational 1 million-person research cohort.
The cohort must be large and diverse enough to be representative of the population, yet easily query-able, says Hudson. “We decided to build a longitudinal cohort…with electronic health record data, a biospecimen survey and baseline exam.”
It’s a “de-novo” cohort, and open to participation by anyone who wants to participate, though much of the data and specimens will come from large health systems, Hudson says. In order to adequately reflect traditionally underrepresented groups, there are also talks of collecting data from consenting patients of federally qualified health centers, 60 percent of whom live in poverty.
Data will be centralized and kept securely in keeping with existing data standards, and all health organizations will have their own sets so they can do federalized queries. “What’s been interesting in this process for me is how much this initiative, and the president’s priority of it, has pushed some of the meaningful use efforts. There’s been a real effort to work with electronic health record vendors on interoperability,” Hudson says.
In order to ensure broad access to the data while also keeping identifiable information secure, there will likely be tiered levels of access. Privacy issues such as this and the question of how to impose penalties on people who misuse data, may require new policies or intervention by Congress, Hudson says.
In a country our size, a one-million-person database may seem small. But participants could be given the opportunity to consent for other studies.
“If done right, this could become a national research movement,” Patrick-Lake says. “This is the future of research on this country.”
Kirsten Stewart is a senior writer for University of Utah Health Sciences