Precision medicine moves from promise to reality [Q&A]

President Barack Obama recently announced a landmark Precision Medicine Initiative, a proposed $215 million investment to advance precision or personalized medicine and use genomics to customize patient treatment.

To learn more about the latest developments and breakthroughs in precision medicine, its vast potential and the regulatory implications, FierceHealthcare spoke with Gregory R. Weidner, M.D., medical director of primary care innovation and proactive health at Carolinas HealthCare System, an innovative network of more than 900 locations including academic medical centers, hospitals, physician practices, surgical and rehabilitation centers and other facilities throughout North and South Carolina. 

With a background in quality, medical informatics and technology, Weidner is working with his team to design and develop new models of care delivery that leverage team-based, technology-enabled, person-centered care and that promote patient engagement and empowerment.

In an exclusive interview with FierceHealthcare, Weidner shared his insights into what healthcare leaders across diverse types of organizations should know about the emerging world of precision medicine.

FierceHealthcare: It sounds as though you view precision medicine as being about much more than genomics, as it's commonly associated with. What's the broader definition?

Greg Weidner, M.D.: At this point in the game, precision medicine is an evolving entity, with an opportunity for people to look at it from many vantage points. When most folks hear "precision medicine" or "personalized medicine," they go immediately to the genomic elements of it. That's a critical piece of the potential but it's certainly not the entirety of personalized or precision medicine.

What we're trying to do is individualize and personalize care based on a variety of factors, which would include their genomic profile as well as various elements of their environment, lifestyle, personal preferences, clinical data and other pieces of data that we know or could know about them.

While cancer care and research are two areas where precision medicine has a head start and incredible potential, there's also much potential in prevention and treatment of other disease states such as heart disease, diabetes and genetic disorders of metabolism. There's also opportunity for improving the health of populations through lifestyle modifications.

Broadly, we're trying to gather as many data points on as many people as we can to better inform how to prevent and treat disease.

FH: Speaking of all these pieces of data--do we have the tools now to track and use them?

GW: We can point to examples where new sources of data generated from patients or nontraditional sources of clinical data are helping to drive new models of care delivery and improve the outcomes for patients with a variety of conditions.

But the evolving understanding of data science, data stewardship and how we put this all together is still very much a work in progress. And obviously there are concerns about privacy, security, data ownership, data liquidity, interoperability--all of those things that will take shape over the next five to 10 years and help us get to a point where we can not only do this, but do this at scale.

FH: Another data-centric movement happening now is the push toward population health. How would you describe the relationship between precision medicine and population health?

GW: I think they should have a very symbiotic and mutually supportive relationship to one another, and that we will redefine each through the lens of the other.

There has been some controversy over the relative commitment to public health versus precision medicine, but I don't think they're mutually exclusive. As we know, the environmental, structural and social determinants of health are critical to improving the health of populations and for public health missions.

For example, if you're attempting to work with a patient to make a change to some aspect of their lifestyle, we have a potentially better chance of doing that if we can make it more personal to them--and answer the question, "Why does it matter to me?"

In the long run, the ability to leverage the best of both movements will allow us to do what we're capable of in terms of improving outcomes, reducing costs and improving access to care for all.

FH: You mentioned that data privacy and security were a concern. What are some of the other regulatory challenges and questions precision medicine presents?

GW: Cost is another issue, which includes the ethics of where to spend the money. The notion that we might know how to cure a condition that affects a small number of people but at substantial cost, and how to determine when and where to prioritize that versus a condition that may affect more people but be less impactful to the individual.

The Food and Drug Administration is working to address the notion that our current frameworks surrounding drug approval, device approval, oversight and privacy aren't designed for the type of fast-paced development environment we're in now.

Regulatory bodies are working hard to develop new frameworks that can encourage innovation while maintaining appropriate regulatory safeguards. There's active work going on in those realms, which needs to continue.

FH: Other than funding, research and updated regulations, what does precision medicine need to realize its potential?

GW: The critical piece is engaged and empowered patients and citizen scientists who are willing to share their data and participate in communities that will help us crowdsource answers to questions, find solutions and feed the data streams that ultimately will help us solve issues of health and disease.

The parallel to that is we need an evolving paradigm within the medical community where the idea of an empowered citizen scientist or patient is seen as a welcome partner in the journey toward health, as opposed to there being an adversarial relationship.

We need a very open, community oriented, collaborative approach to care that puts the patient in a position that we've not seen before, and gives them the opportunity to help lead the change.