Obama Plans $215 Million Precision Medicine Effort for Cures

How Big Data May Revolutionize U.S. Health Care

President Barack Obama said he will ask Congress for $215 million to fund his vision for a million-strong cohort of volunteers whose genetic and health data will be used to develop personalized medicine.

“Precision medicine -- in some cases, people call it personalized medicine -- gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen,” Obama said Friday at the White House, where he announced the initiative.

The White House proposal will be part of the fiscal 2016 budget that Obama plans to submit to lawmakers on Feb. 2. The National Institutes of Health, with $130 million, will spearhead the development of the national cohort, while the National Cancer Institute will get $70 million to focus on genomic drivers in cancer.

“Precision medicine is a game-changer,” said Jo Handelsman, associate director for science at the White House office of science and technology policy. “It holds the potential to revolutionize the way we approach health in this country.”

Precision medicine holds promise because the cost of genomic sequencing has fallen dramatically, from hundreds of millions of dollars to about $1,000 per patient. The lower costs, in conjunction with advances in scientific understanding of the disease, has led drugmakers to pursue more personalized therapies for cancers and numerous genetic disorders.

Patient Access

The study across 1 million patients will differ from traditional research as the NIH seeks to engage patients and let them have access to their own data, NIH Director Francis Collins said Thursday at a press conference.

“People who participate are true partners -- not subjects, not patients, but true partners,” Collins said. He said he hopes participants will be motivated to be part of a project “for the nation, for their children and grandchildren.”

The volunteers will be drawn in part from existing groups of patients, such as those in a study by Kaiser Permanente that is testing women and their partners for mutations that could cause serious diseases in children.

To facilitate the flow of data between participants and researchers, the Office of the National Coordinator for Health Information Technology will have $5 million to develop standards to address privacy and security of health data. The U.S. Food and Drug Administration will use the remaining $10 million to develop ways to regulate precision medicine testing.

Congressional Support

The funding request is subject to approval by Congress, where Republicans who hold majorities in the House and Senate have resisted many of the president’s spending priorities. Obama said that while investments in basic research don’t always pay off, there is support from both political parties for the idea. “There’s a huge economic stake” for the U.S. in tapping such innovations, he said.

Obama’s proposed funding may not be enough to support the project.

“I think the polite way to say it is that it’s a good start,” said Gianrico Farrugia, chief executive officer of Mayo Clinic’s Florida campus and former director of Mayo’s Center for Individualized Medicine.

Kick Start

“It is certainly really encouraging that there is alignment between the NIH and the White House, and it kick starts the thing we need to do, but it’s an initial investment just to start things,” Farrugia said by telephone.

Even at the relatively low price of about $1,000 per genome, sequencing 1 million volunteers would cost $1 billion, 10-fold than what is being allocated for the project.

In comparison, the government spent $1.3 billion on a National Children’s Study that sought dietary and environmental explanations for childhood diseases. The project was scrapped in December after only enrolling 5,700 children, half of the originally planned number.

“Of course, we would love to have the whole genome sequence on all the participants but the expense has to be considered,” Collins said at the press conference. He said he hoped that the cost of sequencing would continue to fall as the NIH worked on assembling the patients.

Data Issues

As the group is put together, the NIH will likely face challenges in getting all the data on the same page, even though drawing from existing populations is necessary to speed up the process, said Vertex Pharmaceuticals Inc. Chief Executive Officer Jeffrey Leiden. Vertex’s drug Kalydeco for patients with cystic fibrosis was given a nod from Obama during his State of the Union speech as an example of the type of personalized medicine he hopes the initiative can produce.

“There’s a practical issue here,” Leiden said by telephone. “When you put multiple databases together, you need to make sure that the components are the same, that you’re using the same definitions, the same phenotyping” -- information about a patient’s characteristics, such as eye color.

Kalydeco is the first drug for cystic fibrosis that addresses the underlying cause of the disease. Patients have a genetic mutation that results in buildup of sticky mucus in their lungs, which causes damage and usually leads to death by their mid-20s.

The initiative could also encourage standardization in data gathering at hospitals around the country, according to Charles Baum, CEO of cancer drugmaker Mirati Therapeutics Inc.

“The way genotypic and phenotypic analysis is performed is different at different hospitals, and we don’t always know if the results can be compared across all patients,” Baum said in an e-mail.

Obama will present the proposed funding to Congress on Feb. 2 as part of his fiscal budget for the year.

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