Testifying before a U.S. House subcommittee on March 3, National Institutes of Health Director Francis Collins, M.D., credited the advent of electronic health record systems with providing the big data necessary for President Obamas new $215 million Precision Medicine Initiative.
Collins told a hearing on NIHs fiscal year 2016 budget request, held by the House Subcommittee on Labor, Health and Human Services and Education, that information about the interaction between genes and environment that results in disease has been elusive to date.
Yet, with electronic health records now becoming the norm, the NIH director asserted thats why this is the right time to initiate a program of this sort whose aim is groundbreaking and historic. Collins commented that without advances in EHRs, environmental sensors, and DNA analysis at an increasingly affordable cost we couldnt have probably done it 10 years ago, but now we can.
According to Collins, scientific advances also are accelerating progress toward a new era of precision medicine. Historically, doctors have been forced to base their recommendations for treatment on the expected response of the average patient, he explained. But recent advances, including the plummeting costs of DNA sequencing, now make possible a more precise approach to disease management and prevention that takes into account individual differences in genes, environments, and lifestyles.
NIH is taking a lead role in the multi-agency Precision Medicine Initiative that also includes the Food and Drug Administration and Office of the National Coordinator for Health IT. While NIH would receive $200 million under the initiative, FDA is earmarked to get $10 million to modernize the regulatory framework to aid the development and use of molecular diagnostics in precision medicine, while ONC would spend $5 million to help develop technology and define standards and certification criteria to enable the exchange of genomic data.
Collins told lawmakers that in the near-term the Precision Medicine Initiative will focus on cancer and efforts aimed at understanding why cancers develop drug resistance using non-invasive methods to track therapeutic responses and exploring new treatments targeted to the genetic profiles of a wide range of adult and pediatric cancers.
In the longer term, he said that the goal of the initiative is for NIH to launch a national research cohort of 1 million or more volunteers who will play an active role in how their genetic and environmental information is used to prevent and manage a broad array of diseases, including diabetes, heart disease, and Alzheimer's disease. We havent really had a sufficiently large study with appropriate patient participation, Collins added. With a million people, youre going to have enough events that you should really begin to be able to dissect what the biomarkers were that warned this might happen and what were the environmental factors that played a role.
By collecting data for a million Americans, the NIH director said the agency will be able to harness the unprecedented power that comes from having critical information about their medical experiences, DNA, and environmental exposures. We havent had that kind of power before and we aim to get it, he said.
A project of this magnitude will lay the groundwork for new prevention strategies and novel therapeutics, Collins argued. Theres no better time than now to embark on this enterprise to revolutionize medicine and move this precise personal approach into everyday clinical practice.
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