Obama’s precision medicine initiative catches up to, spurs cancer research

Before President Barack Obama announced a precision medicine initiative in his State of the Union address last week, many Americans were probably unfamiliar with the term. Not cancer researchers.

“Oncology has been on the leading edge of precision medicine,” said Dr. Gary Gilliland, president and director of Fred Hutchinson Cancer Research Center and an expert in cancer genetics. Much of his career has centered on precision medicine, which focuses on targeted treatments for patients.  

Gilliland and other top cancer researchers praised the initiative Friday when the Obama administration released additional details, including plans to amass genetic and health data on more than a million American volunteers to better understand genetic causes of disease and streamline drug discovery. 

“It’s tremendous that the president recognizes that precision medicine is going to ultimately dominate how we take care of patients and how we make decisions in clinical care,” Gilliland said. “We’ve been doing this in oncology for years — identifying [genetic] mutations that we can target with specific therapies — and are realizing the value of that both from the perspective of the patient and from the perspective of third-party payers.”

At a briefing in the White House, President Obama called the $215 million initiative “one of the biggest opportunities for breakthroughs in medicine that we have ever seen.” The initiative would provide:

• $130 million to the National Institutes of 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 to scale up efforts to identify genomic drivers in cancer and develop more effective treatments.  
• $10 million to the U.S. Food and Drug Administration to overhaul its regulatory structure and streamline drug approvals.
• $5 million to address communication across databases and the secure exchange of information.

The funding, in the president’s budget for the 2016 Fiscal Year beginning Oct. 1, is subject to congressional approval.

More specific details of the initiative are still being developed. But rather than establishing a single biobank or database, federal officials described the effort as a research consortium that would link existing efforts around the country.

Dr. Eric Holland, senior vice president and director of the Human Biology Division at Fred Hutch and director of Solid Tumor Translational Research, is the overseer of the very kind of genetic and clinical database that the Obama administration wants to engage.  Hutch Integrated Data Repository and Archive, or HIDRA, which is currently under construction, will combine clinical records with tumor genetics and molecular data with the aim of eventually helping doctors choose the best targeted treatment.

“I would definitely hope we could figure out how to integrate our efforts into a more national effort to achieve the kind of things we want to do,” said Holland, senior vice president at Fred Hutch.

Precision medicine means different things to different people, Holland explained. At its simplest, it involves testing an individual’s tumor to identify mutations, then seeing whether drugs that target that particular mutation are either available or in clinical trials. Or it might involve identifying mutations in the tumors of patients who respond unusually well to certain drugs in order to find other patients with the same mutation who might also benefit.

HIDRA takes these efforts a step further by linking a patient’s clinical data — diagnosis, treatment, response to treatment — with his or her tumor’s genetic data, and then integrating this with information from thousands of patients. Ultimately, when someone is diagnosed, a physician will be able to enter the patient’s information and see which treatments were most effective for others with similar cancers.

“Our ability to predict responses will increase dramatically by having lots of examples,” said Holland. “That’s why it should be driven by the government: It’s for the whole population of the nation.”

Gilliland cited research by Holland and others as positioning Fred Hutch as one of the leaders in precision medicine.

“Most major cancer centers have the capacity to identify the common, actionable mutations that occur in a significant proportion of cancer patients,” Gilliland said. “We have the capacity to do that, but in addition to that, we are part of the engine that drives the discovery of these new gene mutations, and that may help with drug development.”

If such personalized treatment sounds expensive, it actually holds the potential of both improving patient care and holding costs down, Gilliland said.

For starters, the cost of DNA sequencing — analyzing the full set of a person’s genes, or their genome — has dropped sharply, to about $1,000. In addition, precisely targeted therapy has the ability to save money, said Scott Ramsey, a health economist and co-director of the Hutchinson Institute for Cancer Outcomes Research (HICOR).

“When we identify tests that will better identify people who will respond to therapy, it could reduce the cost of care or provide more cost-effective care,” he said.

Identifying what won’t work is as important as identifying what will. About a third of patients who get cancer therapy don’t respond to it, Ramsey said. Knowing which tumors are unlikely to respond would allow patients to avoid futile and often harsh treatment and also to seek other treatment.

“If we can avoid exposing people to toxic drugs that are very expensive when we know they won’t work, that’s a big benefit,” he said.