Washington, D.C., is championing precision medicine push
By AMERICAN HEART ASSOCIATION NEWS
Precision medicine is generally supported by all political groups and getting personal attention from the top government levels, which is why leading advocates were encouraged to seize the chance to push that agenda at a summit this week.
“This is a topic amazingly of interest to Democrats, Republicans and the President all at the same time. As far as I know, it’s the only topic which pretty much they have agreement,” the Food and Drug Administration’s Robert Califf, M.D., said Wednesday at the American Heart Association’s inaugural Thought Leader Summit on precision cardiovascular medicine.
Califf said President Obama has made personal phone calls to help facilitate his push for precision medicine, a topic he championed earlier this year with a $215 million proposal.
“This is really a time for you to apply the elbow grease because, regardless of everything else, if the president gives you a personal phone call, I notice that things do tend to get done,” said Califf, FDA’s deputy commissioner for medical products and tobacco.
Precision medicine is a fast-growing approach to medicine that sets up a tailored approach to patient care, as opposed to a one-size-fits-all approach. The goal is to provide precise disease treatment and prevention by factoring in data related to a person’s genetics, environment and lifestyle habits.
Earlier this year, President Obama rolled out a precision medicine initiative that focused primarily on cancer.
At Wednesday’s conference, a wide-ranging group of representatives from academic medicine, information technology, government, pharmaceutical, and health organizations discussed how best to set the precision medicine agenda – and overcome hurdles – when it comes to cardiovascular disease.
“Our task is to try to sort out how we can define a given disease in a given person as precisely as possible, thereby giving us more insight into specific kinds of therapies with minimal toxicities,” said the summit’s chairman, Joseph Loscalzo, M.D., Ph.D.
A large goal behind precision medicine has been the collection of massive amounts of health data from individuals that researchers can crunch and analyze for genetic patterns that might identify specific ways to diagnose and treat individuals.
But that has raised ethical concerns over personal privacy.
Some summit participants wondered whether developments in precision medicine could provide an opening to revamp the federal privacy rule known as the Health Insurance Portability and Accountability Act to address those concerns.
Others raised questions about the reliability of the data being analyzed, mainly because of a wide range of collection methods, a lack of uniform taxonomy and loose disease modeling.
“It’s not that we’ve figured all this out,” Susan Autry, executive director of AHA’s new Institute for Precision Cardiovascular Medicine, told conference participants.
“We’re hoping you’re going to help us design and develop this. The questions around ‘Who’s the consumer? Who are the users?’ are important in designing this. Just to be clear – we don’t have the design written out. We’re hoping you will help contribute to the design of it. Where should we be focusing?”
The medical and clinical research communities increasingly have embraced precision medicine since the 2003 scientific breakthrough of the sequencing of the human genome. That milestone allowed experts to design specific medical treatments based on the DNA sequence of individuals.
AHA has committed $30 million to support the Institute and its efforts, with a tentative pledge to commit another $30 million within another five years and employ an aggressive fundraising campaign.
Conference participants encouraged AHA to play a role in both encouraging and educating scientists and the general public in contributing to clinical trials that would support the mission of precision medicine. They also expressed support in having AHA, as a neutral “trusted broker and trusted brand,” oversee the creation of a portal where data could be amassed.
The National Institutes of Health is working on the world’s largest study of how genes influence disease prevention and treatment. It has already collected the genomic sequencing of tens of thousands of individuals.