|President Barack Obama|
President Obama has made the creation of a huge, technically challenging database the centerpiece of his precision medicine proposal. The initiative will draw on existing resources and new studies to gather data on the biology, behavior and health of more than 1 million people.
Writing in the New England Journal of Medicine, the directors of the National Institutes of Health (NIH) and the National Cancer Institute (NCI) outlined their vision for the database. Researchers will take a deep dive into the biology of each participant, characterizing their cell populations, proteins, metabolites, RNA and DNA, performing whole-genome sequencing when money permits. These data will be paired with behavioral details and linked to electronic health records. While some have doubts about the utility of such a database, many view it as having huge potential to improve drug discovery.
However, technical and financial challenges must be overcome before there is a database capable of settling the debate. The NIH is in line to receive $130 million for its 1 million-person database. As a comparison, the United Kingdom has committed $150 million to its 100,000 Genomes Project. The NIH plans to stretch the $130 million by making use of data from existing studies. Piggybacking on other projects will prevent duplication in the data gathering stage, but create its own set of problems. NIH director Francis Collins has acknowledged interoperability is potentially a stumbling block.
Obama's budget proposal includes $5 million for the development of interoperability standards and data security systems. The NCI and the FDA are also set to receive $70 million and $10 million, respectively, bringing the total budget for the precision medicine proposal up to $215 million. NCI will use its money to study the genomic drivers of cancer, while the FDA is tasked with developing a new approach to regulation of next-generation sequencing (NGS) technologies.