Steve Halasey, chief editor, CLP

With a single sentence in his State of the Union Address for 2015, President Obama has set the federal wheels in motion on a new path with significant implications for the clinical laboratory community.

“Tonight,” the President said, “I’m launching a new precision medicine initiative to bring us closer to curing diseases like cancer and diabetes—and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

Federal officials wasted little time before beginning to flesh out the initial details of the initiative. In a blog post on January 30, Margaret A. Hamburg, MD, FDA commissioner, drew out the implications of the precision medicine initiative in relation to the agency’s emerging regulatory policies for diagnostic applications of next-generation sequencing (NGS), which will be the subject of a public meeting on February 20. “Reliable and accurate NGS technologies promise to accelerate ‘personalized’ or ‘precision’ medicine, the tailoring of medical treatment to the individual characteristics of each patient,” she wrote. “But they also pose some novel issues for FDA in carrying out our mission of protecting and promoting public health.”

Writing in January 30 edition of the New England Journal of Medicine, Francis S. Collins, MD, PhD, director of the National Institutes of Health (NIH), and Harold Varmus, MD, director of the National Cancer Institute (NCI), argued that recent advances in research methods, biologics databases, and data analytics have “dramatically improved” the prospects for the success of a precision medicine strategy. “What is needed now,” they wrote, “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.”

On the same day, President Obama hosted an event attended by clinicians, scientists, and industry leaders to outline details of the initiative as they will be expressed in his proposed budget for 2016. All told, the initiative will provide $215 million to federal agencies, including:

  • $130 million to NIH, to develop a national genomic research cohort of a million or more volunteers.
  • $70 million to NCI to identify genomic drivers of 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 curated databases to support the regulatory structure for precision medicine.
  • $5 million to the Office of the National Coordinator for Health Information Technology to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.

But not quite everyone is ready to leap on the federal precision medicine train. In an op-ed published in the January 28 New York Times, Mayo Clinic anesthesiologist and physiologist Michael J. Joyner, MD, warned that, “Unfortunately, precision medicine is unlikely to make most of us healthier.” Instead, he suggested, federal agencies would do better to target their funding at known and controllable healthcare targets:

Like most “moonshot” medical research initiatives, precision medicine is likely to fall short of expectations. Medical problems and their underlying biology are not linear engineering exercises, and solving them is more than a matter of vision, money, and will.

We would be better off directing more resources to understanding what it takes to solve messy problems about how humans behave as individuals and in groups. Ultimately, we almost certainly have more control over how much we exercise, eat, drink, and smoke than we do over our genomes.

Also conspicuously absent from the discussion about diagnostics for precision medicine has been any inkling of a new approach to aligning existing reimbursement policies with the goals of the initiative. In seeking out the involvement of the laboratory community, it would be a good idea for federal agencies to start the conversation with a willingness to pay appropriately for clinical laboratory testing, including the new tools that will be developed under the initiative. The lab community has been waiting many years for that conversation to take place. Perhaps now is the time to make it a reality.

Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199