Precision Medicine Initiative: New Challenges for 2015 and beyond

President Obama’s Precision Medicine Initiative is already on the table and offers $215 million to support the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and ONC.

Precision, or personalized, medicine (as opposed to a “one size fits all” vision of the “average patient”) isn’t new. Blood typing, genetic sequencing, and other scores of database organized information has been used to share research and information over a century. However, this initiative is based on the broadening of this concept:

                 “The prospect of applying this concept broadly has been dramatically improved by the recent development of large-scale biologic databases (such as the human genome sequence), powerful methods for characterizing patients (such as proteomics, metabolomics, genomics, diverse cellular assays, and even mobile health technology), and computational tools for analyzing large sets of data. What is needed now is a broad research program to encourage creative approaches to precision medicine, test them rigorously, and ultimately use them to build the evidence base needed to guide clinical practice.” A New Initiative on Precision Medicine Francis Collins and Harold Varmus

The goal is simple, but definitely not easy: scientists will assemble databases of about a million volunteers to study their genetics and other factors such as environments and microbes in hopes of using that information to combat cancer. The data sets will allow scientists, physicians and other public and private sector organizations to “study and improve health outcomes, fuel the development of new treatments, and catalyze a new era of data-based” medical treatment. (White House Fact Sheet: President Obama’s Precision Medicine Initiative)

Investments and Scope of the Initiative

This proposed initiative, then, will focus on several key investments:

“Complementing robust investments to broadly support research, development, and innovation, the President’s 2016 Budget will provide a $215 million investment for the National Institutes of Health (NIH), together with the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) to support this effort, including:

  • $130 million to NIH for development of a voluntary national research cohort of a million or more volunteers to propel our understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing.
  • $70 million to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.
  • $10 million to FDA to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health.
  • $5 million to ONC to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.

FACT SHEET: President Obama’s Precision Medicine Initiative

Challenges Ahead

This initiative will prove challenging to the Department of Health and Human Services, as well as to the Medicare Program because accountable care comprises “an estimated 20% of total Medicare payments.” Kyle Murphy, on EHR Intelligence wrote in an op-ed for EHR Intelligence, stated today. He goes on, “Meanwhile, the House Committee on Energy & Commerce is moving forward with the discussion phase of its 21st Century Cures initiative which aims at speeding along patient-centered regulation and supporting medical researchers, clinical data sharing, clinical research, and product regulation.”

We can add this to our growing trends in healthcare list, and can safely say that the first quarter of 2015 will be one of the most significant chapters in the advancement and transformation of healthcare in the United States.

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