The “Precision Medicine Initiative†that was briefly mentioned by President Barack Obama during his State of the Union Address last week will require a $215 million initial investment, with the goal of discovering cures for diseases such as cancer and diabetes.
The “Precision Medicine Initiative” that was briefly mentioned by President Barack Obama during his State of the Union Address last week will require a $215 million initial investment, with the goal of discovering cures for diseases such as cancer and diabetes.
“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 2016 budget request will include $215 million for the National Institutes of Health (NIH), the 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’s 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.”And while every investment doesn’t always pan out, every $1 spent on the Human Genome Project so far, which helps support the innovation of precision medicine, has already returned $140 to the economy.
“There’s a huge economic stake in us tapping in to this innovation,” the President said. “But as anyone who has watched a loved one battle with an illness, particularly a life threatening illness . . . the most important impact these investments can have can’t be measured in dollars.”
President Obama went on to say that precision medicine “gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen.”
And for a small subset of patients, the promise of precision medicine is already here.
Physicians and researchers have realized for some time now that a “one-size-all” approach wasn’t going to work anymore. And in the field of cancer, a growing understanding of the disease and accompanying genetic mutations have led to earlier detections and more targeted therapies to treat certain cancers.
“We live in an extraordinary time when the scientific opportunities and our ability to translate this new knowledge into ways to both save and improve the quality of life of patients are simply astounding,” Margaret Foti, PhD, MD (hc), chief executive officer of the American Association of Cancer Research, said in a statement. “This is why we are so excited about today’s event at the White House and specifically about President Obama’s major investment in the enormous potential of precision medicine, which is in the very early stages of transforming health care.”
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.”But even with costs lowering for genomic testing, integrating those tests and results into practice is still going to take time.
“With whole genome or whole exome testing, you can go into the test with one goal in mind, but more information is gathered on other health risks as a result of the test,” Joy Larsen-Haidle, MS, CGC, a genetic counselor at the Humphrey Cancer Center and the President of the National Society of Genetic Counselors , said in a phone interview.
“It’s going to be really important for patients to understand what the test is going to tell them, how they’re going to use it in their medical care, and to participate in that informed consent process so that they’re ready to hear that information.”
Haidle feels that there are changes that can be done now that can help impact access to genetic services.
“Some of the things that we might think about today are how do we improve access to genetic experts, such as a genetic counselor,” she said. “One of those ways, from our perspective, is if we can get genetic counselors recognized as providers under CMS, that decreases an access barrier for our senior citizens and also for some other patients that are covered by a third-party payer.”
Haidle said there is also a need for standardization of how much family history is collected and better utilization of electronic medical records to help physicians and providers keep track of family history.
And with studies showing that some physicians are uncomfortable with ordering genomic testing because they do not know how to interpret the results, practices are going to have to start developing a more team-based approach that includes genetic counselors.
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