What is all the Fuss About Precision Medicine?

precisionmedicineOn January 20, 2015, as part of his State of the Union address, President Obama announced the upcoming launch of the White House’s Precision Medicine Initiative.(1) The Initiative will allocate $215 million in 2016 for work to collect and use genomic, lifestyle and other clinical data to further research into precision medicine.(2) The response to the Initiative has been rapid and significant: in the short time since its announcement, a two-day workshop on the Initiative has been held, with working papers and presentations from multiple stakeholders, and an advisory committee has been formed to help develop and implement a significant portion of the Initiative. The initiative is another example of the current trends and challenges related to health technologies, data privacy and security. It also provides insight into the future of data-driven medicine.

The term precision medicine has been popularized recently  as a way to more accurately emphasize molecular-level information aiding patient diagnosis and treatment decisions.(3) Precision medicine starts with the basic idea that an individual’s genetic makeup, environment, lifestyle and other patient-specific information may be predictive not only to the individual’s future health, but also to their responsiveness to treatment options.(4) For example, a precision medicine approach to treating a patient might involve genetic testing to help a provider determine which of several available therapeutic agents for a given condition will result in the best patient response.

In support of the initiative, President Obama’s 2016 budget proposes to distribute the allocated funds to three different agencies: $130 million to the National Institutes of Health (NIH) to aid in the development of the national research cohort; $70 million to the National Cancer Institute (part of NIH) to aid the research and application of the genomic drivers of cancer; $10 million to the FDA to support the development and regulation of databases and next generation sequencing technologies; and $5 million to the Office of the National Coordinator for Health Information Technology (ONC), which helps to coordinate federal data privacy policy, to develop interoperability standards addressing the privacy and security of sharing research data.

These allocations require congressional approval, and there have been early signs of bipartisan support for the Initiative.(5) This funding is part of an overall research funding package proposal (including a nearly $1 billion increase in funding to the NIH) that reflects the Obama administration’s intention to invest in biomedical research innovations.(6) In context, the Initiative is also important because it shows a growing interest in data sharing, aggregation and utilization on a very large scale.

  1. Fact Sheet, The White House, Office of the Press Sec’y, President Obama’s Precision Medicine Initiative (Jan. 30, 2015). (link: http://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative)
  2. Office of Mgmt. & Budget, Exec. Office of the President, Budget of the United States Government, Fiscal Year 2016, 19 (2015). (link: http://www.whitehouse.gov/sites/default/files/omb/budget/fy2016/assets/budget.pdf)
  3. Alla Katsnelson, Momentum Grows to Make ‘Personalized’ Medicine More ‘Precise,’ 19 Nature Med. 249, 249 (Mar. 2013).
  4. Lindsay Holst, The Precision Medicine Initiative: Data-Driven Treatments as Unique as Your Own Body, White House Blog (Jan. 30, 2015, 9:19 AM). (link: http://www.whitehouse.gov/blog/2015/01/30/precision-medicine-initiative-data-driven-treatments-unique-your-own-body
  5. Press Release, U.S. Senate Chairman’s Press, Alexander to Meet with White House on Precision Medicine Initiative (Jan. 30, 2015)  (link:http://www.help.senate.gov/newsroom/press/release/?id=9ecc098f-c428-4f73...)
  6. Jeannie Baumann, New NIH Advisory Panel will Develop Million Person Cohort for Obama Plan, 9 Bloomberg BNA Life Sci. L. & Indus. Rep. 225 (Feb. 13, 2015)

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