by Russell Jaffe, MD, PhD, CCN, and Jayashree Mani, MS, CCN
Too many people sacrifice their health to gain wealth. Then they sacrifice their wealth to regain their health, so often living in the past and the future rather than in the moment that when they pass they barely have lived.
Predictive biomarkers can speed the transition from the current sick care system, which is unsustainable, to a more promising healthcare. A heavy lift, agreed, yet an attainable objective.
Predictive Biomarkers – Selection and Significance
Predictive biomarkers (PB) are defined here as the specific subset of tests that, when referenced to best outcome goal values rather than usual or normal statistical ranges, predict ten-year survival. Standards are rigorous for inclusion as a PB. To qualify, each test must predict all-cause mortality. This means the test has been performed and observed in every region, socioeconomic group, and with sufficient tracking of tests results over time to confirm ten-year predictive value. Each PB covers an aspect of epigenetics, lifestyle choices, and habits of daily living.
For the first time, interpretation of these functional PB tests can include a lifestyle action plan based on quantitative risk reduction. Functional goals listed here cover all of epigenetics. Epigenetics includes the 92% of lifetime health determined by habits of daily living. This aspect of personalized medicine is proving effective in cost and outcome in studies to date. When compared to current best standards of care, a million lives lost prematurely and at high medical expense can be prevented at lower costs. The net result is to enrich society and reduce resource drain. This loss of life is predicted by modifiable epigenetic habits of daily living that can add life to years and years to life at high value to clients and communities and low human and financial costs.
This proactive approach is evidence based and has been shown to lower costs while enhancing individual outcomes, reducing risks, and adding ‘years to life and life to years.’ This also helps to fulfill the triple aim of better health, better care, and lower costs.
This systems biology application of PB is the first conceptual advancement in lab medicine since sensitivity, specificity, and predictive index were introduced a generation ago. Integrative, comprehensive, personalized medicine now has evidence-based, objective, predictive biomarkers to determine and quantify both risk and response to therapy.
Usual (Statistical; ‘Normal’) Test Results vs. Predictive (Best Outcome; Anticipatory) Goal Value Results
Conventional clinical lab tests provide information about “usual” or “normal” statistical ranges for a particular item analyzed. They are useful for population studies yet not individually predictive.
PB tests provide information that delivers ‘feel the difference results’ within a few months of implementing individual habit changes based on the PB tests results.
The goal values recommended here for each predictive biomarker are designed to achieve the least risk or highest gain for each physiologic function measured. When predictive biomarker tests are at their goal value, all cause morbidity and mortality are at their best outcome value; quality of life and lifespan are optimized; net costs of care are reduced. PB goal values are not age adjusted because the interpretations of the tests results reported here are based on “least risk, best outcome” healthier goal values. Healthy people at all ages have the same lab ranges. As people accumulate age, there are more unhealthy people in each progressive decade. What we call aging is not only dependent on our genetic destiny but also on habits of daily living. While chronology is fixed, functional age is a choice. This is a reason why using predictive biomarkers based on goal values is an advancement compared to the previous statistical normality approach. The predictive goal values for the PB explained here are also based on evidence from many studies covering all ethnic groups over long periods of time in regard to all cause morbidity and mortality, that is, life expectancy. The probability of living ten plus years for these predictive biomarkers is also based on large scale, long-term community-based outcome studies.