The Obama administration has unveiled new details of its Precision Medicine Initiative, including a $215 million budget request to “pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.”
“Precision medicine” is a reminting of what most people have understood as “personalized medicine.” It has its roots in the U.S.-led international Human Genome Project which was completed in 2003 after 19 years of collaborative effort to find the sequence of chemical base pairs which make up human DNA, and to identify and map all of the genes of the human genome from both a physical and functional standpoint.
Fast-forward to now, and that historic breakthrough has spawned a White House fact sheet description of precision medicine as “an innovative approach to disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.”
In doing so, it says, clinicians will get “tools to better understand the complex mechanisms underlying a patient’s health, disease or condition, and to better predict which treatments will be most effective.”
Precision medicine’s potential to improve patient care and accelerate the development of new treatments has only just begun to be tapped, the fact sheet says. “Translating initial successes to a larger scale will require a coordinated and sustained national effort.”
Although $215 million isn’t a lot by today’s budgetary standards, it gets even bigger and better than that.
The White House says its Precision Medicine Initiative will rely on collaborative public and private efforts to “leverage advances in genomics, emerging methods for managing and analyzing large data sets while protecting privacy, and health information technology to accelerate biomedical discoveries. The initiative will also engage a million or more Americans to volunteer to contribute their health data to improve health outcomes, fuel the development of new treatments, and catalyze a new era of data-based and more precise medical treatment.”
Of the $215 million, $130 million would go to the National Institutes of Health to develop a voluntary national research cohort of a million or more volunteers to set the foundation for a new way of doing research through engaged participants and open, responsible data sharing, according to the fact sheet.
The National Cancer Institute would get $70 million to scale up efforts to identify genomic drivers in cancer and apply that knowledge to develop more effective approaches to treatment.
FDA would get $10 million to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure.
And the remaining $5 million would go to the Office of the National Coordinator for Health Information Technology to support the development of interoperability standards and requirements that address privacy and secure data exchange across systems.
In addition to accelerating the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, the initiative includes among its objectives commitments to protecting patient privacy and the development by FDA of “a new approach for evaluating next-generation sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.”
The initiative’s objectives seem more than ambitious for the money the White House is seeking from a Republican Congress, whose leaders quickly denounced the FY 2016 Obama budget upon which it will depend.
Perhaps that is a sly strategy the White House is using in the initiative: $215 million might be small enough to not be noticed by the budget slashers on Capitol Hill, who have slammed the overall document as “laughable” and “shamelessly panders to the Democratic base.”
The conservative American Enterprise Institute, whose scholars can usually be relied upon to be skeptical of government spending initiatives, harbored a caveat-sprinkled but cautiously encouraging response to this one.
Wrote David Shaywitz who attended patient- and medical expert-saturated White House launch event: “It’s difficult not to be struck by both the audacity and the difficulty of the President’s initiative. Developing effective cures for complex disease is generally far more complicated than identifying a single causative gene.”
He went on to offer cautious encouragement to the initiative’s biggest component — the integration of data from one million volunteers. “This project will presumably require three distinct components — creating, integrating, and analyzing complex datasets — each of which is hard but not impossible.”
Even House Energy and Commerce Committee chairman Fred Upton (R-MI) was quoted as saying the initiative “is a natural fit in the discussion about how to accelerate and improve the discovery, development and delivery of new cures and treatments. This is something we’ve been talking about for the past year.”
First called “personalized medicine” as far back as 2003 if not earlier, precision medicine may prove to have enough of a wholesome, public benefit aura about it as the nation tries to put abundant bad news behind its return to characteristic optimism, that it will escape the slashers’ axes.
There’s even talk that Republican lawmakers might want to put some of their own ideas into it.