The Obama administration is set to reveal Friday that it will earmark $215 million in the 2016 budget to power the Precision Medicine Initiative that the president first introduced in his recent State of the Union address.
Precision medicine is the concept of using personalized information--often related to a patient's genetic profile--to tailor treatments to specific individuals, a departure from the traditional one-size-fits-all approach to treating diseases.
"I want the country that eliminated polio and mapped the human genome to lead a new era of medicine--one that delivers the right treatment at the right time," Obama said in his address.
While the use of precision medicine is not yet mainstream, it has already been in use for a number of years in tailoring personalized treatment for cancer patients, FierceHealthcare reported.
To achieve its goal of bringing precision medicine to the masses, the White House released the following details about several organizations' role in the initiative:
The National Institutes of Health (NIH) is slated to receive $130 million so it can recruit "a million or more" volunteers to share their health data in order for researchers to increase their understanding of health and disease.
The National Cancer Institute would get $70 million to identify genomic drivers in cancer and use that knowledge to develop better treatment.
The Food and Drug Administration (FDA) would receive $10 million to support the regulatory structure needed to advance innovation in precision medicine while protecting public health.
The Office of the National Coordinator for Health Information Technology would get $5 million to implement interoperability and privacy standards for the health data involved.
"I believe that precision medicine is a game changer," Jo Handelsman, associate director for science at the White House Office of Science and Technology Policy said on a conference call with reporters Thursday. "It holds the potential to revolutionize how we approach [healthcare] in this country … and ultimately around the world."
Now is the perfect time to ambitiously pursue developments in precision medicine, NIH Director Francis Collins said during the conference, in part because the cost of sequencing a human genome has fallen exponetially since the process was first introduced. The first human genome cost $400 million to sequence, he said, and now the price hovers around $1,000.
There has been speculation that the main goal of the Precision Medicine Initiative would be to create a national, centralized "biobank" containing patients' genetic information. But Handelsman said the initiative will instead try to gather and add to genomic data from a variety of previously existing "cohorts" such as those used by facilities already practicing precision medicine.
The effort will be aided by the prevalence of electronic health records, Collins noted, but "as we all know, it's not trivial to figure out how to glue them together."
Such a large-scale collection of private health data also raises privacy issues, a concern not lost on the initiative's backers.
Participants' privacy will be "rigorously protected," Handelsman said. To that end, her office has started to assemble "privacy working groups" composed of bioethicists and lawyers to offer guidance throughout the effort to develop precision medicine.
The FDA also will tailor its regulations to accomodate the initiative, according to Director Margaret Hamburg, adding that "we must be confident that these [genomic data sequencing] platforms are capable of producing reliable and accurate results" that are also meaningful for both provider and patient. The agency will also revamp its regulations that are currently around a "one-test, one-disease paradigm," she said.
Regardless of the many practical hurdles facing the initiative, Handelsman said she believes the field of healthcare can only stand to gain from expanding precision medicine.
"We are far from unlocking its full potential," she said.
To learn more:
- check out the White House fact sheet
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