In an effort to make the current "one-size-fits-all" approach to medicine a thing of the past, the Obama administration has unveiled details about its Precision Medicine Initiative, an exciting and ambitious approach to personalizing the way we treat an assortment of diseases.
Obama announced the initiative during his recent State of the Union address, saying he wants to "bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier."
Precision medicine is a targeted approach to healthcare in which biotechnology and medical records will be used to segment groups of individuals according to their unique medical needs. To make it happen, researchers will be called upon to collect the personal health information of millions of volunteers to study their genetics and other data, including personal microbial and environmental factors. Instead of giving the same treatment to everyone, precision medicine will involve precise diagnoses and the delivery of more personalized — and, it stands to reason, more effective — medical treatments.
To that end, Obama is going to ask Congress for $215 million. Here's how he's going to spend it:
- $130 million to NIH [National Institutes for Health] for development of a voluntary national research cohort of a million or more volunteers to propel our understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing.
- $70 million to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.
- $10 million to FDA to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health.
- $5 million to ONC to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.
The big winners: The NIH and cancer research.
The NIH will need its new money to conduct the biomedical research and to study the millions of people required to create an accurate database. An absolute ton of outreach is going to be required to recruit the millions of people needed to contribute their health data. To that end, patients and participants will need to be told that (1) their medical records will be secure and (2) that their participation in these efforts will result in new treatments and improved health outcomes.
As for the Initiative's objectives, they were described by the White House as follows:
- More and better treatments for cancer: "NCI will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national 'cancer knowledge network' that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions. "
- Creation of a voluntary national research cohort: "NIH, in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research."
- Commitment to protecting privacy: "To ensure from the start that this Initiative adheres to rigorous privacy protections, the White House will launch a multi-stakeholder process with HHS and other Federal agencies to solicit input from patient groups, bioethicists, privacy, and civil liberties advocates, technologists, and other experts in order to identify and address any legal and technical issues related to the privacy and security of data in the context of precision medicine."
- Regulatory modernization: "The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its critical privacy and participant protection framework."
- Public-private partnerships: "The Obama Administration will forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics, and to launch a voluntary million-person cohort."
The initiative also aims to establish a single, cohesive database linking the genetic and microbial profiles of millions of people.
The White House plans to call upon academic medical centers, researchers, foundations, privacy experts, medical ethicists, and medical product innovators to, in the worlds of NIH Director Francis Collins, "help us put real specifics into what is now an exciting but somewhat general plan."
The proposed initiative has two main components: a near-term focus on cancers and a longer-term aim to generate knowledge applicable to the whole range of health and disease. Both components are now within our reach because of advances in basic research, including molecular biology, genomics, and bioinformatics. Furthermore, the initiative taps into converging trends of increased connectivity, through social media and mobile devices, and Americans' growing desire to be active partners in medical research.
Exciting stuff! It's been a long time coming, but the era of personalized medicine may finally be at hand.
[ WhiteHouse.gov ]
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