by Leah Ramsay


For years the enormous power of the data created by the digital age has been harnessed by marketing agencies, to predict consumer preferences and purchases, and by political strategists to win elections. Healthcare is playing catch-up, and the government is leading the effort to utilize modern computing and data crunching to save and improve lives.


“Precision medicine” was the subject of a White House summit last week, and plans are moving forward for a historic 1 million-person research study, the largest in government-funded research study in U.S. history. Berman Institute Assistant Director for Science Programs Debra Mathews was in attendance, and captured video of President Obama making a significant statement about the future of medical care and research in the age of big data:



The concept of individuals owning their health data, as the President suggests in the video, is a significant one; one generation ago, there were no electronic health records or widely available genetic testing … or smart phones with health apps, online patient forums, and a whole host of other “digital breadcrumbs” relevant to health (or anything else). Now volumes of this data exist, and grow every day.


The White House notes that medical treatments have been designed for the “average patient.” As a result of this “one-size-fits-all-approach,” treatments can be very successful for some patients but not for others.  Precision medicine is beginning to change this with its innovative approach of taking into account individual differences in people’s genes, environments, and lifestyles.


However, the existence of this volume of health information where none previously existed leaves logistical and ethical holes in determining how it will be managed and utilized; meanwhile the knowledge base itself grows, and the technology and biological science continue to move forward rapidly.


With President Obama’s support, the National Institutes of Health (NIH) are diving into the emerging precision medicine trend and bolstering its development with the proposed $215 million Precision Medicine Initiative (PMI). The centerpiece is the PMI Cohort Program, which will use over half of the total PMI budget to build a national, large-scale research participant group of 1 million or more US citizens by 2019. The goal is to have 79,000 enrolled by the end of 2016.


Vanderbilt cardiac disease researcher Dan Roden gave Science an example of the need and potential benefit for having such a huge study group; the discovery of rare variants in a gene called PCSK9 that regulates cholesterol levels has led to a new class of potential drugs for lowering cholesterol. To study such extremely rare mutations requires “a very large denominator,” or huge numbers of subjects, Roden says.


Nancy Kass, the Berman Institute’s Deputy Director for Bioethics and Public Health, will chair the PMI Cohort’s central Institutional Review Board (IRB), which will oversee the research to be conducted with volunteers and ensure that ethical considerations are woven into the fabric of this massive undertaking.


“It’s really, really important to get this right,” Kass told Bloomberg BNA in an interview, adding, “This is the largest research enterprise that our government has ever invested in, and in that way [the cohort] has so much visibility for the American public.”


Kass notes that, in addition to the usual responsibilities of an IRB to protect human research participants, it will be particularly important to underscore to participants that they agree to be re-contacted for future research, and to provide public engagement opportunities and transparent information about the research process.

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Leah Ramsay

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