Temple University is one of the latest to join the NIH?s All of Us program. Learn about the clinical and business reasons behind the precision medicine move, and what you need to think about before doing something similar.
The All of Us Research Program is gaining momentum. All of Us is a National Institutes of Health (NIH)-sponsored precision medicine effort aimed at advancing individualized prevention, treatment, and care by learning more about how lifestyle, environment, and biological factors influence health.
Temple University is one of the latest to join, and be the first in its region. But to Susan G. Fisher, MS, PhD, who is the All of Us Co-Lead Investigator at Temple, it wasn’t primarily about being first in Philadelphia. “While we are thrilled to be the [first] Philadelphia representative in this study, the fact is we are the right [institution],” explained Fisher, who is Professor and Chair of the Department of Clinical Sciences at Temple’s Lewis Katz School of Medicine (LKSOM). “It is especially important for individuals who identify as members of minority groups to be included in this study.”
All of Us aims to enroll one million individuals who will voluntarily share information about themselves, including environmental, physiologic, and health data, as well as biospecimens. Participants will come from all walks of life, including minorities who traditionally are underrepresented in such efforts. Temple is located in the heart of North Philadelphia. “We think it is so important to have residents in this area included,” said Fisher.
Susan G. Fisher, MS, PhD (left above), and Arthur M. Feldman, MD, PhD (right above), lead the All of Us Research Program at Temple University’s Lewis Katz School of Medicine. They say joining the precision medicine initiative intends to help address specific health disparities in their community. (Photos courtesy of Lewis Katz School of Medicine at Temple University)
Tangible Community Benefits of Joining All of Us
Listening to Fisher and her colleague speak, it becomes apparent why it is important. Arthur M. Feldman, MD, PhD, who is Temple’s All of Us Lead Investigator, provided two tangible reasons why participation in All of Us is important for the health of their community.
- Earlier diagnosis. Feldman–who is also a Laura H. Carnell Professor of Medicine at LKSOM–specializes in researching dilated cardiomyopathy that is not caused by a prior heart attack, a common form of heart failure. Six in every 10 who experience the disorder have a genetic mutation in a single gene. Moreover, evidence shows that different ethnic and racial groups can have unique genetic variants. In fact, individuals of African ancestry who have heart failure have unique variants that are not found in individuals of European ancestry, several of which are associated with nearly a two-fold risk of experiencing worsening heart failure or death. “We’re very interested in the genetics of heart muscle disease in the population that we care for in North Philadelphia, but genotyping has been a challenge because until recently neither private insurance companies nor the federal government would pay for the tests and they are expensive,” Feldman explained. “Getting involved with All of Us is a way to address this specific health disparity.”
- Personalized healthcare treatments. Feldman said he looks forward to the day when gene therapy can be used in individuals with cardiovascular disease. “We want to do the same things [in patients with heart disease] that oncologists are doing today-treat people based on genotyping.” For instance, today, patients with heart failure are treated first with a beta-blocker, then an angiotensin enzyme inhibitor, followed by a diuretic. “We know that beta-blockers work in only about 20% of [people in] this group, but we don?t know which ones. With genotyping, we will know which particular drug is best.”
Genotyping and Looking Past the Short Term
Feldman acknowledged the effort will take time. “This isn’t a hundred-yard dash, it’s a marathon.” He noted that Temple is genotyping individuals of all ages, all races, and all ethnicities. For younger participants, questions will come up about their risks and best treatments when they are in their 50s and 60s that All of Us will aim to answer. “It’s a long-term journey.” Feldman also pointed out that the All of Us study is sponsored by the NIH through participating universities and not through health systems. However, health systems are also looking at efforts to genotype their populations to improve the healthcare that they deliver.
In an era where quick return on investment often rules the day, smart health system executives are looking past the short term and looking at the bigger picture. Temple gets it, said James M. Crawford, MD, PhD, who chaired the Precision Medicine Institute’s 2019 conference for hospital and health system executives.
“To be a healthcare provider in a regional market and not be involved in precision medicine is to move backwards by staying in place,” offered Crawford, who is Professor and Chair, Department of Pathology and Laboratory Medicine at the Zucker School of Medicine at Hofstra University/Northwell. “It’s incumbent for a health system to at least stay abreast of precision medicine and potentially take a leadership role.”
For health system executives considering a stepped-up precision medicine effort, Crawford suggested answering these questions first:
- What resources are required to participate in a precision medicine initiative? Think about skill sets and talent you will need to participate effectively.
- How is your relationship with the community you serve? “Remember, you are establishing a more intimate relationship in your regional community. People are sharing more than just blood work and molecular data,” explained Crawford. “They are sharing personal information that addresses socioeconomic determinants of health. Health systems have to step up their relationship with the community when they enter a program like this.”
- How will a precision medicine initiative benefit your community? This is important because the ultimate payoff may be a long way off. Be prepared to preach patience, but also recognize the potential for short-term benefit. For example, if a potentially life-changing mutation is discovered in a patient, mechanisms should be in place to bring this information immediately into their ongoing healthcare.
Temple is now recruiting volunteers and collecting blood samples, the latter of which are being sent to a central data repository. The team is working toward enrolling 50 participants per week through various initiatives, including advertising outreach.
Besides improving healthcare, a key goal of precision medicine is to lower costs. “The best way to do that is to keep people healthy,” Crawford said.