Momentum Builds for National Plan for Precision Medicine

During President Barack Obama’s State of the Union Address, he announced a nationwide Precision Medicine Initiative that would help cure diseases such as cancer and diabetes. On Jan. 30, he built on his announcement and outlined a $215 million plan to help develop precision medicine nationwide.

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

The President’s 2015 fiscal year budget request will include $215 million for the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the National Coordinator for Health Information Technology (ONC), to support and foster the goals of precision medicine.

The administration will provide $70 million of the funds to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.

“We want to use that knowledge to develop new and more effective approaches to help people beat this disease,” the President said.

President Obama also mentioned that the administration would work together with the FDA to develop new approaches for evaluating next generation genetic tests by approving $10 million to acquire additional expertise.

“The way we approve a new gene sequencing technology is going to be different than the way we approve a new pacemaker or prosthetic device,” he said.

The NIH will receive $130 million to develop a voluntary national research cohort of 1 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.

“Just like analyzing our DNA teaches us more about who we are than ever before, analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” he said.

The administration will also make sure that patient privacy remains a top priority, he stressed.

The ONC will receive $5 million to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.

The President mentioned that patient rights advocates will be hands-on in assisting with designing this part of the initiative.

He also called on hospitals, researchers, and privacy experts to join in the initiative and for entrepreneurs and nonprofits to help create tools “that give patients the chance to get involved as well.”

Because we want every American ultimately to be able to securely access and analyze their own health data so that they can make the best decisions for themselves and for their families,” the President said. “This has the possibility of not only helping us find new cures, but it also helps us create a genuine healthcare system as opposed to just a disease care system.”

Advances in these technologies mean that the breakthroughs we’ve already made are just the beginning, the President said.

When Francis S. Collins, MD, PhD, the director of the NIH, first sequenced the first human genome, it cost about $100 million. Now, it costs less than $2000, the President said.

But behind the cost, is the real goal the President said:

“We’re here to harness what is most special about America, and that is our spirit of innovation, our ability to dream, to take risks, to tinker and try new things. And as a result of that, not only improve our economy, but improve the lives of men and women and children of generations to come.”

Carl Harrington, president of the International Waldenstrom’s Macroglobulinemia Foundation (IWMF), can attest to the success of personalized medicine in WM, a rare and slow-growing type of non-Hodgkin lymphoma. On Jan. 29, Imbruvica (ibrutinib) became the first FDA-approved therapy for the disease.

“Personalized medicine or precision medicine certainly plays a role in WM,” he says. “Ninety percent of us have this MYD88 mutation, and then another 28 to 30 percent of us have another mutation called CXCR4.” Research of WM has discovered that patients with CXCR4 mutations may not respond as well to Imbruvica.

“These mutations highly respond to medicines, but it depends upon which of these mutations we might have,” Harrington says.

While Imbruvica is not a cure, it’s definitely a success for WM and for personalized medicine, he says. “We’ve never had as many clinical trials as we do now and we’re grateful for that.”

Benefits Beyond Cancer Treatment

An initiative to improve personalized medicine not only has a benefit to improve treatment, better understanding on genetics will help cancer survivors.

"When we're done with the focus of fighting this cancer and we're moving on to 'What do I need to do next,' taking a really careful look at the family history...might help identify what other health problems survivors should be aware of," says Joy Larsen-Haidle, a genetic counselor at the Humphrey Cancer Center and the President of the National Society of Genetic Counselors.

For families that include an individual who was diagnosed at a young age or who had more than one cancer, or if three individuals on one side of the family are diagnosed with the same or related cancer, meeting with a genetic counselor could be helpful in identifying a potential hereditary risk.

Because the focus for a patient is treatment at the time of diagnosis, meeting with a genetic counselor may not have been recommended at the onset.

"Meeting with a genetic counselor [after treatment] may help a patient feel empowered when they are thinking of next steps and planning for the future," she says.

Because of advances in genetic research, scientists are doing a much better job not only helping patients survive that initial cancer, but also reduce the chance of getting a new cancer down the road.

"You can be in control and be empowered, the cancer doesn't have to be in control," she says. ​