President Barack Obama is asking Congress for $215 million to fund what he calls a precision medicine initiative that would aim to move away from one-size-fits-all treatments and instead tailor them to an individual’s genetic makeup, the White House announced Friday.
Scientists hope to assemble databases using about a million volunteers to study their genetics — and other factors such as their environments and the microbes that live in their bodies — for the project.
“You can match a blood transfusion to a blood type. That was an important discovery,” Obama said Friday during a speech at the White House about the initiative. “What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine were as simple as taking our temperature? That’s the promise of precision medicine.”
Precision medicine figured into the president’s recent State of the Union address, in which he said that he wanted the United States "to lead a new era of medicine, one that delivers the right treatment at the right time."
Early efforts to achieve breakthroughs in the emerging field of precision medicine have included patients with certain cancers who undergo molecular testing in choosing which drug is their best match. Also, people with a rare form of cystic fibrosis can now choose a drug designed specifically to target the genetic defect causing their illness. Some medical centers, such as the Mayo Clinic, have opened "individualized medicine clinics."
Until recently, the cost of genomic sequencing has been too high, and the computer power of medicine insufficient, to make it possible for large-scale pursuit of the approach, Francis Collins, director of the National Institutes of Health (NIH), told reporters during a conference call on Thursday.
The hope is to "harness the power of science to find individualized health solutions," Collins said.
In the short term, precision medicine holds the most promise for treating cancer because scientists already know a lot about the molecular signatures of different tumors, Collins added.
The NIH will lead the genetic database initiative, and though details are still being worked out, the agency plans to use some large genomic studies already under way as well as new volunteers to create the pool of 1 million people, he said.
In his Friday speech, Obama touted economic benefits that he said the investment would bring about. He cited one study about the Human Genome Project, the government-planned research initiative that kicked off in 1990 and found that every dollar spent to map the human genome returned $140 (PDF) to the economy — though that conclusion has been contested.
“There’s a huge economic stake in us tapping into this innovation,” Obama said.
Of the $215 million in Obama’s 2016 budget for the initiative, $130 million would go to the NIH to fund the research cohort and $70 million to NIH's National Cancer Institute to intensify efforts to identify molecular drivers of cancer and apply that knowledge to drug development.
A further $10 million would go to the Food and Drug Administration (FDA) to develop databases upon which to build an appropriate regulatory structure. Another $5 million would go to the Office of the National Coordinator for Health Information Technology to develop privacy standards and ensure the secure exchange of data.
The effort may raise alarm bells for privacy rights advocates, who in the past have questioned the government's ability to guarantee that DNA information is kept anonymous. They have expressed fear that participants may become identifiable or face discrimination.
Also, the funding is likely not enough to sequence 1 million genomes from scratch. Whole-genome sequencing, though plummeting in price, still costs about $1,000 per genome, Collins said, meaning this component alone would cost $1 billion.
Instead, he said, the national cohort would be assembled both from new volunteers interested in "an opportunity to take part in something historic," and from existing cohorts that are already linking genomic data to medical outcomes.
Perhaps the most audacious effort in human genome mapping already underway is by the nonprofit organization Human Longevity, headed by geneticist Craig Venter. In 2013 it launched a privately funded project to sequence 1 million genomes by 2020.
"We're happy to work with them to help move the science," Venter told Reuters in an interview, referring to the administration's initiative.
But because of the many regulations surrounding medical privacy and human volunteers, he said, "we can't just mingle databases. It sounds like a naive assumption" if the White House expects existing cohorts to merge into its million-genomes project.
Venter raced the government-funded Human Genome Project to a draw in 2000, sequencing the entire human genome using private funding in less time than it took the public effort.
Collins conceded that mingling the databases would be a challenge, but he insisted it is doable.
"It is something that can be achieved, but obviously there is a lot that needs to be done," he said.
Collating, analyzing and applying all this data to the development of new drugs will require changes to how products are reviewed and approved by health regulators.
Margaret Hamburg, the FDA's commissioner, said during the conference call that the emerging field of precision medicine "presents a set of new issues for us at FDA." The agency is discussing new ways to approach the review process for personalized medicines and tests, she said.
Al Jazeera and wire services