Recently, President Obama outlined his Precision Medicine Initiative, which generated a lot of buzz. If successful, the plan will move medical research toward personalized treatment options that are based on people’s genetics, environment, lifestyle, and individual preferences. I’m excited that the White House is recognizing and committing funding towards an approach to health care research that FORCE has been endorsing for 16 years. Since 1999, FORCE has been a leader in promoting personalized medicine research, and increasing access to advances resulting from this research. We’ve helped thousands of people make informed healthcare decisions surrounding hereditary cancer risk, prevention, detection, and treatment. We will offer our expertise and lessons learned over the past 16 years to assist the National Institutes of Health and other government agencies in the implementation of this initiative.
Highlights of the President’s plan, which correspond closely with much of FORCE’s longtime work and our future goals include:
- Developing new cancer treatments based on genetic information
Experts know that hereditary cancers develop and behave differently than sporadic cancers; they use this knowledge to develop new approaches to preventing and treating these cancers. FORCE has championed research of PARP inhibitors and other novel approaches against HBOC-related cancers. We continue to mobilize
patients to enroll in clinical trials, and urge the FDA to facilitate development and approval of new therapies to fight hereditary cancers. This past December, our efforts were rewarded: the FDA approved Lynparza (olaparib), a PARP inhibitor therapy, to treat advanced hereditary ovarian cancer caused by BRCA1 or BRCA2 mutation in women who have received prior chemotherapy.
- Identifying and addressing privacy issues associated with genetic medicine
FORCE worked as a member of the Coalition for Genetic Fairness throughout its 13-year effort to ensure passage of the Genetic Information Nondiscrimination Act (GINA). Signed into law in 2008, GINA prohibits genetic discrimination in health insurance and employment. Throughout the legislative process, we regularly updated our community about the issues, what we were doing, and what our members could do to hasten the passage of GINA. Even after the law was passed, we continued to educate with a survey to assess consumer knowledge about genetic discrimination. In 2009, we presented our findings, which were later published in a scientific journal, at the annual meeting of the American Society of Human Genetics. Our efforts to support GINA continue. We inform consumers about GINA laws, and are currently working on legislative protections against genetic discrimination in life and disability insurance.
- Working with the FDA to establish a regulatory framework that includes genetic information
In 2009, FORCE submitted testimony to the Secretary’s Advisory Committee on Genetics Health and Society (SACGHS) objecting to the lack of a regulatory body to monitor certain aspects of genetic testing for consumers and health care providers. We have urged regulators to establish federal oversight of marketing of genetic tests, tracking of adverse events, and monitoring providers’ adherence to pre-testing genetic counseling requirements. As a direct result of our testimony, the FDA implemented a system to track adverse outcomes of testing. In ongoing communications, we encourage the FDA to consider the unique aspects of hereditary cancers in an effort to expedite development and approval of drugs specifically targeted to these diseases.
- Empowering patients in the era of personalized medicine
Following delays of PARP inhibitor research, FORCE mobilized HBOC stakeholders to educate and inform health care providers and consumers to strategically increase enrollment in critical HBOC targeted therapy clinical trials. We continue to empowerindividuals to advocate for themselves and family members, and to participate fully in their healthcare decision making based on their own unique circumstances. FORCE provides straightforward, easy-to-understand material on all aspects of hereditary cancer, and timely medical, scientific, and genetic information from highly trained experts. We offer easily accessible peer-to-peer support—both in-person and virtually. FORCE also participates in many alliances; collaborating with academic institutions, other advocacy groups, and industry to facilitate better outcomes for our community members.
- Creating a million-person, patient-powered research network
FORCE is making impressive progress towards this goal. Our ABOUT Network is the only patient-powered research network built and governed by and for the HBOC community. One of only 29 networks participating in the development of the National Patient-Centered Clinical Research Network (PCORnet), ABOUT will connect health information and outcomes with the electronic health records of 70 million Americans. This highly innovative database is a government-funded initiative. According to Joe Selby, MD, MPH, Executive Director of the Patient-Centered Outcomes Research Institute, PCORnet will, “harness the power of health data from millions of patients, properly safeguarded, to conduct research more efficiently.” As part of PCORnet, ABOUT is well positioned to participate in the Precision Medicine Initiative. In fact, the Precision Medicine Initiative highlighted stories that demonstrate the power of personalized medicine. FORCE member and patient advocate Melanie Nix, who serves on the ABOUT Network Steering Committee was featured in the Precision Medicine Initiative blog (you can read more about Melanie’s story and why she joined ABOUT in our recent
newsletter). To achieve our research goals quickly, ABOUT is seeking to enroll as many Americans as possible into the registry. By collecting real-world health care experiences, our research will drive improvements in the quality of health services; highlight best practices for preventing, diagnosing, and treating hereditary cancer; and ultimately improve future outcomes.
As pioneers and supporters of personalized medicine, FORCE will work hard to assure that this initiative will incentivize research, prioritize global access to quality care, and improve outcomes for people affected by HBOC. Along the way we will engage stakeholders to make sure that our efforts are responsive and representative by:
- training members of our community to participate in research advocacy through our FRAT program
- connecting trainees to opportunities where they can represent the HBOC community on research advisory boards and panels.
- enlisting trained FRAT advocates to participate in our ABOUT Network governance and work groups to help determine how the research will be conducted.
- using community input to generate unanswered questions needed to make informed medical decisions through our ABOUT Generator And Percolator (GAP) Tools.
- collaborating with partners that can help us engage people from underrepresented populations.
- providing members the opportunity to help prioritize research.
- disseminating research findings to consumers and health care providers.
We look forward to working with our community, policymakers, government agencies, advocates, medical experts, and biotechnology companies to advance the conversation around personalized and precision medicine, while making sure that the interests and concerns of people with HBOC remain at the forefront of this initiative. Stay tuned!