Precision Medicine

Credit: NHGRI

White House fleshes out Obama’s $215 million plan for precision medicine

The White House today revealed a price tag and other details of the precision medicine initiative announced in President Barack Obama’s State of the Union address last week. As expected, much of the $215 million proposed to launch the multiagency initiative in the 2016 fiscal year, which begins in October, will support building a cohort of 1 million American volunteers for genomics and other biomedical research. Another chunk of money will fund efforts to understand the genomes of cancer cells. (Click here for a White House fact sheet on the plan and here for a National Cancer Institute [NCI] fact sheet.)

Precision medicine, a term for tailoring treatments to an individual’s genetic makeup, microbiome, and other factors, is “a game changer” that “holds the potential to revolutionize the way we approach health in this country and ultimately around the world,” said Jo Handelsman, associate director for science in the White House Office of Science and Technology Policy, in a call with reporters yesterday to discuss the initiative. The $215 million will be new money added to agencies' budgets, not funds redirected from existing programs, added National Institutes of Health (NIH) Director Francis Collins. 

As ScienceInsider previously reported, the centerpiece of the initiative—funded with $130 million in 2016—will be a longitudinal research cohort consisting of at least 1 million volunteers. Such large cohort studies of both healthy and sick people that represent the general population—often referred to as biobanks—are already established in countries such as the United Kingdom and Japan.

The U.S. cohort will be assembled by linking existing cohort studies. There are at least 200, ranging from the Framingham Heart Study to a genetic and medical patient database at Kaiser Permanente in northern California, that could be invited to join, Collins said. The initiative may also recruit new volunteers to “fill gaps” and ensure diversity, Collins said.

Besides drawing on existing information—such as electronic medical records—and analyzing patients’ genomes, the study may have participants wear devices to monitor their health and activity, such as Fitbits. And in a departure from conventional cohort studies, patients will be actively involved in designing the study and controlling use of their data, officials said. (These features make it “more than a biobank,” Collins said.) A blue ribbon panel will plan the study, advised by working groups—one made up of lawyers, ethicists, and others is already forming to look at protecting privacy, Handelsman said.

Another $70 million will go to cancer genomics at NIH’s NCI. NCI is winding up a 9-year project called the Cancer Genome Atlas that has cataloged mutations that appear to drive the growth of cancer cells, and has several trials under way to treat patients based on their tumor’s mutations. This area is “the leading edge of precision medicine,” Collins said; many patients, such as those with breast cancer, already receive genetic or other molecular tests to determine the best drug.

The new money will allow the agency to expand trials of genetically tailored treatments, explore cancer biology, and set up a “cancer knowledge network” for sharing this information with researchers and oncologists treating patients.

The Food and Drug Administration (FDA) will receive $10 million for hiring experts to help evaluate tests based on sequencing large parts of a patient’s genome, and to build databases of disease mutations, such as one used to review two new tests for cystic fibrosis genes, explained FDA Commissioner Margaret Hamburg.

Another $5 million will go to the Office of the National Coordinator for Health Information Technology to develop ways to securely exchange and preserve the privacy of patient data.

President Obama is expected to unveil details of the initiatives at 11 a.m. ET today at the White House before an audience of researchers, drug company executives, and others. Congress will have to ultimately approve the spending on the initiative, which will be part of the 2016 budget request the White House is expected to unveil on Monday.

Click here to see all of our Budget 2016 coverage.

*Update, 30 January, 2:55 p.m.: A statement that had been erroneously attributed to Dr. Collins has been corrected. 

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