Obama Lifts Curtain on 'Precision Medicine' Plan

By Rita Rubin
WebMD Health News

Reviewed by Michael W. Smith, MD

Jan. 30, 2015 – The "Precision Medicine Initiative," a move toward tailoring medical treatments to individuals, promises to improve the health of Americans as well as that of the economy, President Obama said Friday in a White House speech.

The promise of precision medicine, Obama said, is "delivering the right treatments at the right time, every time, to the right person."

Obama, who announced the plan in his State of the Union address, said he intends to ask Congress on Feb. 2 for $215 million to fund the program's first year. "There's bipartisan support for the idea... which makes me very happy," he said.

"We have the possibility of leading an entirely new era of medicine that makes sure new jobs and new industries and new lifesaving treatments for diseases are created right here in the United States."

Research has shown that for every dollar the U.S. spent on mapping the human genome, $140 has been added to the economy, Obama said. He was referring to a 13-year project to map all the genes of a human being for the first time. But he said that "the most important impact these investments can have can't be measured in dollars."

He cited William Elder, Jr., who was sitting in the audience and was a guest of Michelle Obama's at the State of the Union.

In 2012, Elder, diagnosed 20 years ago with cystic fibrosis, tried a new drug targeting the specific gene mutation that caused his disease. That gene change is found in 1 out of every 25 people with cystic fibrosis, Obama said. The morning after he took the drug, Elder noticed that he could breathe through his nose for the first time. Today, the 27-year-old is in medical school and believes he'll live to see his grandchildren, the president said.

Personalized Medicine

"Precision medicine means moving beyond the one-size-fits-all approach to medicine," Jo Handelsman, PhD, said in a press briefing on Jan. 29. She's the associate director for science at the White House Office of Science and Technology Policy.

Matching a patient's blood type for a transfusion is an early example of precision medicine, says National Institutes of Health Director Francis Collins, MD, PhD. "But for much of medicine, this kind of personalizing has just not been possible. We just didn't know enough," he said at the briefing.

It's possible now because of advances in data science, better computing power, and electronic medical records. It also costs less to do something called genome sequencing, which maps out every gene in your body. The cost to sequence an entire genome (your genetic makeup) has dropped to nearly $1,000 -- that's 100,000 times less than it cost 15 years ago, Collins said.

More than half of the funding for the initiative -- $130 million -- will go to the NIH to develop "one of the largest research populations ever assembled," a nationwide group of at least a million volunteers, Obama said.

Participants will benefit personally by having access to data collected by researchers, Collins said. For example, some people in the existing studies have already had their whole genome or exome sequenced. The exome is part of the genome and contains the blueprints for proteins and most of the known disease-causing gene changes.

Protecting Participants' Privacy

The White House is committed to protect the privacy and security of data collected by the initiative, Handelsman said.

It is putting together a privacy working group that will include lawyers, ethicists, and representatives of patient organizations. Another $5 million for the initiative will go toward the Office of the National Coordinator for Health Information Technology to set up standards to protect the data.

The second-largest share of the president's investment is $70 million for the National Cancer Institute. It will ramp up efforts to identify genes that drive cancer, with the goal of creating better treatments. Collins said the earliest successes in the initiative are expected to be in the field of cancer and in the study of how genes affect your response to medication, called pharmacogenomics.

"For a small but growing number of patients, that future is already here," Obama said. "Eight out of 10 people with one type of leukemia saw white blood cell counts return to normal with a new drug targeting a specific gene. Genetic testing for HIV patients helps doctors determine who will be helped by a new antiviral drug, and who will experience harmful side effects."

Of the remaining funds for the program, $10 million will go to the FDA to set up databases that help analyze and interpret the results.

The agency published a paper in late December about how to improve and quickly make available what it calls "next generation sequencing" diagnostic tests, said FDA Commissioner Margaret Hamburg, MD. The FDA will hold a public meeting on the subject Feb. 20.



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SOURCES: Press conference, President Barack Obama. Jo Handelsman, PhD, associate director for science at the White House Office of Science and Technology Policy. Francis Collins, MD, PhD, NIH director. Margaret Hamburg, MD, FDA commissioner. White House fact sheet. "Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests," an FDA publication.

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