White House Unveils Details of Precision Medicine Initiative
President Obama envisions the creation of a national research cohort to understand health and disease as well as expand the opportunities for research and application of the genetic markers of disease.
Following up on statements made during his State of the Union address, President Obama unveiled an investment of $215 million in his FY 2016 budget toward his Precision Medicine Initiative. The lion’s share of this funding would go to the National Institutes of Health (NIH), particularly the National Cancer Institute, with the aims of developing a national research cohort of a million volunteers and expanding research into the genetic markers of cancer.
In a perspective published in the New England Journal of Medicine, the directors of these two entities, Francis Collins, M.D., Ph.D., and Harold Varmus, M.D., respectively, noted that while the near-term focus is cancer, in the long run the initiative would “generate knowledge applicable to the whole range of health and disease.” (See more in infographic at right.)
Given the challenges involved in prescribing psychiatric medications, a federal focus on precision medicine—defined as getting the right treatment at the right time to the right person—should be welcome news for research on mental illness. But how much would such research benefit from this new initiative?
Bruce Cuthbert, Ph.D., director of the Division of Adult Translational Research at the National Institute of Mental Health (NIMH), acknowledged that mental illness might not reap the same rewards as other diseases.
“Genetic signatures are not as strongly influential for psychiatric illness as they are for disorders like cancer, diabetes, or cystic fibrosis,” he told Psychiatric News. “For mental health, so much risk comes from the surrounding environment and life experiences, which is known as the exposome.”
That’s not to say the White House initiative lacks value. Cuthbert noted that NIMH leadership is pleased with the announcement and on board with this new drive.
New Public-Private Partnership Aims to Bring Precision Medicine to Psychiatry
As part of a partnership among a health care provider, a pharmacy-services provider, and an academic institution, NHS Human Services is leading a 28-month research project to improve outcomes and reduce side effects of psychiatric medications. NHS will collaborate with CareKinesis Inc., a medication-therapy management services provider; Coriell Life Sciences, a pharmacogenomics testing vendor; and the Department of Human Genetics at the University of Pittsburgh, which will provide expertise in genetic testing and genetic counseling. The project, funded by a $350,000 grant from the Polk Foundation, will be a large-scale attempt at pharmacogenomics. The group will tailor personalized-medication regimens for study volunteers based on their genetic profiles. Volunteers will be selected from a pool of adults with mental illness served by NHS in Pennsylvania’s Allegheny, Beaver, Dauphin, and Lehigh counties.
More information is available here.
After all, given the prevalence of mental comorbidities among people with a chronic disease like cancer or diabetes, any improvements in the care of these patients and their outcomes will indirectly improve the mental health of millions of people.
This initiative also aligns with NIMH’s strategic goals, particularly in regard to its version of precision medicine—the Research Domain Criteria (RDoC) project.
The goal of RDoC is to reshape how research looks at mental illness by focusing on deficits in specific neural pathways, such as reward circuitry or working memory, instead of traditional diagnoses and their diagnostic criteria (Psychiatric News, May 2010). In turn, that better neurobiological understanding could lead to more targeted treatments.
For example, anhedonia (an inability to experience pleasure) cuts across mood, anxiety, and affective disorders, but not every depressed individual presents with this condition. But if researchers uncover the mechanisms in the reward circuitry that cause anhedonia, they might find a drug target that can help a wide range of people but not be needlessly used in others.
In this regard, Cuthbert believes that building a national research cohort that includes standard medical records along with genetic and lifestyle data would create an “information commons”—a concept first espoused by the Institute of Medicine in a 2011 report—that is critical in enabling researchers to rethink disease classification and develop more personalized treatments.
NIMH already has developed repositories like the National Database for Autism Research to facilitate these goals, but the new NIH cohort would provide a huge boost in data. “With a large-enough database, we can identify the right grain size we need for a particular disease,” Cuthbert said. “Effective treatment doesn’t necessarily have to always be at the level of the individual; we might be able to find features shared among a larger population subgroup.”
A national patient-powered research cohort will take a while to get up and running, so the benefits of that project are down the road. In the meantime, many researchers who work in the pharmacogenomics arena will likely applaud the $10 million that the Precision Medicine Initiative proposes for the Food and Drug Administration to ensure that the oversight of genomic applications does not stifle innovation and that the technology works and protects patient privacy. ■
More information about the Precision Medicine Initiative can be accessed here.
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Published online: 27 February 2015
Published in print: February 21, 2015 – March 6, 2015
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