The NIH launched its precision medicine initiative ‘All of Us’ on May 6th with the goal of enrolling more than one million people, serving as a research platform of diverse data to improve health through precision medicine. Precision Medicine has been defined as ‘the right [drug] treatment for the right patient at the right time’. This effort resembles initiatives such as the Million Veterans Program (MVP) at the VA.
Recent biological and technological revolutions such as the human genome project, big data initiatives, and electronic medical records (EMR) have changed our approaches to treating diseases. Cardon and Harris define the modern approach as: ‘prevention and treatment that takes individual variability into account.’
What is Precision Medicine Really?
Precision medicine is not new; we have been matching individual blood groups in transfusions for decades – and that is precision medicine. We have been customizing eye glasses to individual’s needs also for many decades – that again is precision medicine. However, we were unable to extend this to many common diseases until recent advances in genomic medicine, big data capabilities and EMRs. As Cardon and Harris also point out, “precision medicine has moved beyond the early phase of hope and hyperbole to a practical reality.”
‘The Precision Medicine Initiative’ [PMI] announced by former President Obama in 2015 advanced the possibilities of precision medicine and its potential to save lives and improve the life quality. We believe that it will also help prevent diseases and improve the health of populations.
The Call to Action for the Federal Health Community
Careful planning is needed to implement the ideas of using precision medicine to prevent cancer. At least eight steps are recognized in implementing health care policies:
1. Describe the problem – This article is the first step in that direction and you can read more below about specific cases.
2. Assess readiness for policy development – It has been 40 years since former President Nixon started the National Cancer Institute. Since then, efforts are focused on improving cancer treatment and management of cancer. Only today, through the technologies we have referenced, are we able to individualize cancer prevention and control efforts. NIH should lead efforts by examining current strategies around cancer and determine how it can be focused on its prevention. However, there are many barriers that need to be overcome, including unwillingness of researchers to share data, confidentiality of data, and cultural biases against the use of genomic medicine (e.g. the Tuskegee syphilis trial). Understanding these challenges informs various aspects of policy that need to be addressed.
3. Develop goals, objectives, and policy options – This will be the next step. First, we must determine the gaps between current policy and the policy that is needed for cancer prevention. The gaps will then be converted into ideas for new policy. An expert panel must be convened to develop these goals, objectives and policy options.
The Healthcare industry is currently designed around treating ailments and should focus more on prevention. The Federal Health community, along with agencies, can work to create a definition of patient-centered care that focuses on prevention. With the adoption of such policies, we should expect to see an overall reduction in Healthcare costs. Policies should be aimed at driving value in Healthcare. The industry can come together to influence policy to improve the quality and experience of care and reduce costs.
4. Identify decision‐makers and influencers – These include:
i. Genomic Medicine Scientists – from NIH and academic medical centers, cancer centers
ii. EHR Experts – Electronic health records (EHR) can also make an impact on the future of medicine, including prevention medicine. While many people are talking about EMRs – which track patient data over time to help coordinate care, we prefer to think about EHRs, such as CMS’ MyHealtheData, which allows data to flow more freely and be more readily available outside of a single Healthcare facility.
The real potential of the EHR is in its ability to contribute to the prevention of diseases, as well as the promotion of health and its contribution to population health research, through the flow of information into and out of the EHR from and to multiple data sources. In a cluster randomized controlled trial in primary care centers of Barcelona, Spain, for instance, an alert in EHR led to an increase in colorectal screening. There are many potential opportunities to leverage the EHR for prevention and outcomes research. So where are we with cancer?
To make initiatives like ‘All of Us’ successful, the NIH Clinical Center needs to be able to partner with academic medical centers and share data effectively to support advanced research in areas such as cancer. To do so, they will also need an interoperability strategy to ensure that data is able to be shared in a standardized way; as well as an advanced analytics strategy that is aligned to specific research goals and outcomes. Careful considerations must be made to ensure that the new EHR will effectively support clinical trials, translational research and prevention and be able to leverage big data and genomic medicine to do so.
iii. Big Data Analysts – New technologies and research have led to the beneficial utilization of big data in many spheres of human endeavors. Data management and analytics in other industries have resulted in greater efficiency and productivity. About 80% of data exists in unstructured format and techniques to make them useful will pay dividends. Although the Healthcare industry was ahead regarding the use of scientific, evidence-based ways to make decisions before other non-health-related industries, it has lagged behind in using big data to its advantage to benefit improving human health. A few reasons for the lack of adoption are concerns over patient privacy and data sharing, interoperability, cost, incentive structure, resilience to change. Focus on policy gaps, like secure data sharing through EHR, modifying the incentive-based structure to bridge these gaps, and well-defined standards for interoperability, will pave the path for value-based care.
iv. Precision Medicine Oncologists – from NCI, cancer centers, and the pharmaceutical industry.
v. Public Health Policy Implementation Experts – includes HHS, FDA, NIH, CDC, genomic epidemiologists.
vi. Representatives from the National Cancer Institute.
vii. Representatives from the Institute of Medicine.
5. Build support for the policy through the Expert Panel
6. Draft and revise the policy
7. Implement the policy – One of the major challenges will be funding.
8. Evaluate and monitor the policy.
Joining the Fight Against Cancer
Cancer is a genetic [mutational] disease; a complex, multifactorial disease; a spectrum of diseases; can be a chronic disease; a disease of aging; and it needs multidisciplinary care. As such, cancer is best dealt with if we use all the modern tools listed above: Genomic medicine, big data-based interventions and EHR-linked tools – for prevention, early detection, treatment and ongoing surveillance to improve outcomes. All of these will enable patient access to (1) data about their personal cancer experience to enhance care coordination and reduce errors in their medical records and (2) data about emerging trends in cancer survival rates relevant to patients’ diagnoses and treatments. Such trend data is imperative to help patients stay informed and equipped to catch future cancer diagnoses early. With more than 15 million cancer survivors in the United States, the aggregation of genomic testing, big data analytics and EHR-linked tools can synthesize trending data to empower providers and patients to work together in preventing, detecting, treating and monitoring future cancer diagnoses. And because many survivors only see their oncologists as needed, more focus should be placed on directly providing trending data to patients as it becomes available so the patients can be proactive in managing and monitoring their health in between visits with providers. Such data access and personalization of cancer prevention and cancer care will yield great dividends. “Cancer prevention requires a broad perspective stretching from the submicroscopic to the macropolitical, recognizing the importance of molecular profiling and multisectoral engagement across urban planning, transport, environment, agriculture, economics, etc., and applying interventions that may just as easily rely on a legislative measure as on a molecule.” Detailing all the items is beyond the scope of this article. However, this article is a starting point for how we can get to “precision oncology.”
Individual patient’s tumors show unique molecular signatures and profiles, thus making traditional histopathological diagnoses to be irrelevant in the future. New molecular, diagnosis-based tumor taxonomy will emerge. “To supplement the site-specific, histology-driven diagnosis with genomic, proteomic and metabolomics information, a paradigm shift in diagnosis and treatment of patients is required.” Genomic and proteomic tests designed to assess the chemotherapeutic benefit of particular drugs for patients can reveal incompatibility of the drugs with patient populations at the genetic level – meaning patients could receive little to no benefit from the prescribed treatment. If providers are unable to recommend alternative treatments, the test data is unactionable and likely unable to produce better outcomes for the patient. The following steps will help enable the beneficial use of genetic test data:
- Reduce barriers to proactive patient adoption of genomic and proteomic testing
- Implement clinical trials of new therapies, as well as trials for various drug combinations and dosing titrations of existing chemotherapy and radiation therapy protocols
- Provide and interpret large data with high data quality
- Develop novel mathematical models to investigate the genomic hierarchy in individual patient’s cancer
- Design new combination therapies based on genomic/other omics pathway determinations
Each one of these steps outlined requires the concepts we have enlisted in this article: genomic medicine, big data and EHRs. Once those concepts are accepted and incrementally implemented in the therapeutic clinical trials, it is conceivable to apply them to the cancer prevention paradigms.
It is predicted that these ideas, if implemented successfully, will lead to sizeable benefits – decrease in cancer incidences, improvement in the cancer outcomes and quality of life, and a positive economic impact on Healthcare costs by reducing the overall cancer burden. The pharma industry spends in excess of $8B, per year. Research suggests that nearly 80,000 patients per year in the U.S. alone could benefit from precision therapies.
Our focus in this article has been to break down a very complex problem into manageable next steps. We look forward to working with the Federal Health community to make this dream a reality!
The full document with references and citations is available here:
About the Authors:
Sanjay “Sonny” Sarma has advised more than 20 leading Healthcare organizations and is a recognized Healthcare thought leader. He has blogged for HIMSS, taught at Harvard Medical School, and been a guest speaker at conferences at MIT. His perspectives on the future of Healthcare were published in 2017 in the book The World Health Strategy. He is the Co-founder of Prosperata, a team of Healthcare and data analytics experts that helps the healthcare industry achieve value through the “Quadruple Aim.”
Srinivasan Vijayakumar, M.D. “Dr. Vijay” is an internationally recognized oncologist, Professor and the Chair of Radiation Oncology at the University of Mississippi Medical Center. He has received numerous grants and has written over 200 scholarly papers and articles in peer-reviewed journals, including the Lancet. Dr. Vijay previously worked at the Cleveland Clinic, the University of Chicago, and the University of California, Davis. He is currently pursuing an MPH from George Washington University to address the cancer burden globally.
Kym is the President of 360 Degree Insights LLC, a woman-owned management consulting firm focused on health information technology strategy, product and service market validation, business development, meeting facilitation, and keynote speaking. Kym leverages her professional expertise as a business development leader and personal experience as a Hodgkin’s lymphoma, melanoma (twice!) and breast cancer survivor to inform healthcare and technology leaders about patient- and consumer-centered approaches designed to address gaps in care, solve complex care delivery challenges and empower healthcare consumers.
Sneha Kavalloor is a physician with 7 years of experience in the field of Homoeopathy. She has cured several acute and chronic ailments as an independent physician and continues to contribute to the field of Homoeopathy. Author of articles for the daily newspaper – ‘Vashi Times’ titled: ”Benefits of Homoeopathy for Children” , “Scope of Homoeopathy in treating Women’s Ailments” and “Role of Homoeopathy in Diabetes Mellitus”. She is currently pursuing her Master’s in Health Informatics from George Mason University. Her current job experiences include working as a qualitative research assistant at George Mason University, analyzing several healthcare initiatives and their outcomes for better future implementations and as Research and Strategy Analyst for Prosperata.