Summary of the Institute for Functional Medicine White Paper

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IFM's white paper, 21st Century Medicine: A New Model for Medical Education and Practice

In an effort to convey the intention of the lengthy white paper submitted by the Institute for Functional Medicine, the Foundation for Alternative and Integrative Medicine (FAIM) has produced the following summary.

The doctor of the future

The doctor of the future will be an integrative healer whose practice differs in many ways from that of today's typical physician. The doctor of the future will provide care that is patient-centered and comprehensive (body, mind, and spirit), care that is both high-tech (using genomic prediction tools, systems biology, and functional medicine, for example) and high-touch. Care will focus more extensively on preventing disease and injury. The practice of the future will be provided by smoothly working teams that will include primary care physicians, complementary and alternative health practitioners, health coaches, and wellness mentors, as well as medical specialists, allied health and nursing practitioners.

Putting the patient in the driver's seat allows representatives from any number of disciplines to serve as navigator through the healthcare system, helping people sort through conflicting data as well as the many difficult choices they must make during their lives in times of both wellness and illness. Tomorrow's physicians will consistently assess new evidence, to ensure that their practices meet the highest standards of quality and patient outcomes.

To a great degree, the body has the capacity to heal itself; this concept, in some ways, opposes the mechanical model in which doctors act as fixers. One goal of future practitioners will be to guide and empower patients toward self-healing.

Integrative Medicine is defined as the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing.

The transformation of 21st century medicine from the prevailing acute-care model to a far more effective chronic-disease model will succeed only if we attack the underlying drivers of the epidemic -- the complex, lifelong interactions among lifestyle, environment, and genetics.

1. Personalized medicine

Under the rubric of personalized medicine lie many other complex issues relevant to biochemical, physiological, genetic and environmental individuality that must also be attended to if we hope to reverse the modern epidemic of chronic disease and assist patients toward healthier lives. This broader model of personalized care has already become an explicit component of systems biology and prospective health care, and it is implicit in the chronic-care model and integrative medicine as well. Personalized medicine is critical to the future of health care.

What is it?

"Nutritional genomics" or, as commonly used, nutrigenomics: The study of how different foods may interact with specific genes to increase the risk of common chronic diseases such as type 2 diabetes, obesity, heart disease, stroke and certain cancers. Nutrigenomics also seeks to provide a molecular understanding of how common chemicals in the diet affect health by altering the expression of genes and the structure of an individual's genome. The premise underlying nutrigenomics is that the influence of diet on health depends on an individual's genetic makeup. (From MedicineNet.com)

"Pharmacogenomics" includes identifying candidate genes and polymorphisms, correlation of polymorphisms with therapies, prediction of drug response and clinical outcomes, reduction in adverse events, and selection and dosing of drugs based on genotype." (Issa, 2007)

"Proteomics": The study of the proteome, the complete set of proteins produced by a species, using the technologies of large-scale protein separation and identification. The term proteomics was coined in 1994 by Marc Wilkins who defined it as "the study of proteins, how they're modified, when and where they're expressed, how they're involved in metabolic pathways and how they interact with one another." (From MedicineNet.com)

"Metabolomics/Metabonomics: The study of metabolic responses to drugs, environmental changes and diseases. Metabonomics is an extension of genomics (concerned with DNA) and proteomics (concerned with proteins). Following on the heels of genomics and proteomics, metabonomics may lead to more efficient drug discovery and individualized patient treatment with drugs, among other things. (From MedicineNet.com)

It will be necessary, therefore, to ensure that whatever transformative model is used, it will allow clinicians to integrate new and useful information from personalized medicine as and when it becomes available, and will also empower them to respond effectively now to the urgent need for improved prevention and management of complex, chronic disease.

2. Prospective health care

A relatively new concept introduced in 2003, prospective medicine is a descriptive rather than a prescriptive term, encompassing "personalized, predictive, preventive, and participatory medicine." prospectively examining individual risks and developing comprehensive preventive strategies based on the best available evidence at the time.

Emerging sciences of genomics, proteomics, metabolomics, medical technologies and informatics are revolutionizing the capability to predict events and enable intervention before damage occurs. Personalized risk prediction and strategic health-care planning will facilitate a new form of care, which we have called "prospective health care."

Including the same four elements as systems biology (prediction, prevention, personalization, and participation), prospective health care offers a much broader perspective, describing structural and procedural transformations that must also occur in reimbursement, research, risk management assessment, record keeping, and the delivery of care.26 The thrust of these changes is "toward managing disease risk and providing personalized care for chronic and acute disease."

One example is Navigenics Health Compass, offering "A scan of your whole genome, carried out by a government-certified laboratory, that captures data on 1.8 million of your genetic risk markers." For $2500, individuals can obtain an analysis of their "genetic predisposition for a variety of common health conditions, and the information, support and guidance to know what steps you can take to prevent, detect or diagnose them early." For $250 per year, they will have a subscription that entitles them to regular updates.

Biomarkers can be assessed through an analysis of 250 serum proteins ($3400). According to the company's Web site: "Biophysical250... measures 250 different biomarkers that may indicate the presence of diseases and conditions often before symptoms appear. Unlike standard physicals that measure only up to 40 biomarkers, Biophysical250 simultaneously assesses hundreds of biomarkers used by 12 different medical specialties."

The big missing piece in prospective medicine (at least as described thus far in the literature) lies in the absence of a clear, practical, and systematic method for altering clinical practice. Thus, it is an important step forward, but it still lacks a robust, consistent architecture for clinical applications.

3. Chronic-care model

The full chronic-care model (CCM), first conceived in 1993, was formally presented in a 2001 publication by Wagner et al. CCM has in common with prospective health care a strong emphasis on redesigning the systems that support and shape clinical practice. Both have explicit emphases on a team approach to chronic care, the necessity of patient self-management, and the urgent need to involve community resources and attract the attention of policymakers.

The primary focus of this model is to include "...the essential elements of a healthcare system that encourage high-quality chronic disease care..., the community, the health system, self management support, delivery system design, decision support and clinical information systems.

The CCM advances our knowledge of how to improve the structure or process of care for chronic disease using standard approaches, but it does not advance our ability to select more effective strategies for actually improving both treatment and prevention. Still lacking is a robust, consistent architecture for selecting the most effective clinical applications for each unique patient.

4. Evidence-based medicine

Evidence-based medicine (EBM) is "the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research." Ideally, it can be used to increase practitioner effectiveness if its strengths are appropriately utilized and its limitations are clear: "The methods of EBM do not supply 'correct' answers but rather information that can improve clinical judgment." Ultimately, the appropriate use of EBM relies on a more precise definition of what constitutes relevance and best evidence for each individual patient encounter.

Unfortunately, there are very few studies available as yet that tell us whether EBM improves overall patient health over a period of years. EBM fails at the same point where the research itself fails—in its inability to account for unique patient geno/phenotypes, multiple co morbidities, and personalized approaches to care that include multiple interventions for complex, chronic disease. Such multifaceted interventions may include dietary, nutraceutical, pharmaceutical and/ or surgical recommendations, as well as many options from the natural medicine world (e.g., botanical medicine, acupuncture and oriental medicine, body/mind practices).

5. Systems Biology

Systems biology as currently pursued focuses primarily, as does personalized medicine, on genetic mechanisms in drug responses, but given a broad vision—and the will and funding to execute on that vision -- it could become the scientific engine driving clinical medicine toward the model we are proposing.

Although there is not yet a universally recognized definition of systems biology, the National Institute of General Medical Services (NIGMS) at NIH provides the following explanation: "A field that seeks to study the relationships and interactions between various parts of a biological system (metabolic pathways, organelles, cells, and organisms) and to integrate this information to understand how biological systems function."

Many of the same obstacles discussed earlier in this chapter vis-à-vis personalized medicine and Pharmacogenomics are inherently shared by systems biology. In addition to barriers of cost, complexity, equipment, ethics, and education, "the evidence and importance of most pharmacogenomics associations are not sufficient to overcome the barriers to clinical implementation…. It is likely that complementary technologies, such as metabonomics, will be able to compensate for some limitations of genotype phenotype association."

Systems biology illuminates the science that will support a new model of health care -- one that is based on an intimate understanding of complex human systems interacting with complex environments and unique genetic inheritances.190 In order to achieve its greatest potential, it must broaden its scope far beyond pharmacogenomics, which represents a very small portion of what we need to know about preventing and treating complex, chronic disease.

6. Integrative medicine

Their definition of integrative medicine is: ...the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing.

We must transform our system of health care through new models for medical education, acute and chronic disease management, research, health insurance, and fiscal responsibility.

We know with steadily increasing confidence and knowledge that the primary driver of chronic disease is the interaction among genes, activities of daily living (lifestyle), and the environment.

The Central Hub of 21st Century Medicine

Clinicians must develop the knowledge and skills to deliver individually tailored care. They must be able (and willing) to incorporate the science of systems biology, the emerging discipline of personalized care, and a much broader array of assessment, therapeutic, and preventive strategies into a new therapeutic relationship.

Near the end of the 20th century, however, the reality of the web-like, chaotic, nonlinear and complex nature of life (and health)—exposed by advances in the systems-oriented life sciences—began to erode this reassuring sense of certainty. Twenty-first century medicine has now come face-to-face with the practical implications of uncertainty—a problem that flummoxed many mid-20th century physicists (including the great Albert Einstein, who ultimately rejected what is now an accepted principle) when they first confronted Heisenberg's articulation of the principle of uncertainty in physics. Fortunately, once the seriousness of this issue is consciously acknowledged, management strategies can be developed. First, however, we have to stop denying the presence and power of uncertainty in medicine.

The first problem that has impeded the successful application of EBM to patient care is the complex nature of the translation of research studies to the individual patient's unique clinical problem(s)—what Larry Weed called knowledge coupling.

Despite these sobering facts, physician education, training, and reimbursement, as well as research designs for clinical studies that physicians depend upon for effective decision making, continue to be focused primarily on an acute-care model that emphasizes pharmacologic solutions for complex, chronic problems, leaving the discerning clinician without the evidence and tools needed for addressing their patients' complex needs.

A Science-Using Profession

How do we transition from an EBM-based, guideline-driven, prescriptive clinical practice to an individualized, patient-centered approach that captures both the science and the art of medicine?

Clinicians must use science; it is a powerful tool. But they should be in charge of how and when to use it, not dominated and intimidated by it.

Because clinical reasoning is very often grounded in heuristics (simplified models that guide evaluation and treatment at an unconscious level of awareness), we argue that to change the outcome, we must change the model. The ability to utilize heuristics when time and information are limited and outcomes are uncertain is a very special cognitive trait -- an evolutionary breakthrough in adaptive cognition. To understand and refine clinical reasoning and clinical practice -- to ultimately improve outcome -- a deeper understanding of these adaptive skills must be understood and consciously applied.

Insight

Solving questions requiring insight generates activity that starts in the prefrontal cortex and eventually extends throughout the cortex and deeper structures, searching for possible experiential information that contributes to the emergence of a pattern. It is the appearance of that pattern that sparks the "aha" or "Eureka!" experience in the connotative language centers of the right brain.

The functional medicine heuristic, on the other hand, requires a carefully nurtured and protected partnership between the clinician and the patient to illuminate the underlying mechanisms of the patient's illness(es). The FM heuristic requires an iterative, cooperative process that yields a more complete narrative story. From a thorough investigation of the antecedents, triggers and mediators of the patient's condition, emerge information and insights that can help to shape a deeper and more comprehensive therapeutic response.

Summary

The Institute for Functional Medicine's model of comprehensive care and primary prevention for complex, chronic illnesses is grounded in both science (the Functional Medicine Matrix Model; evidence about common underlying mechanisms and pathways of disease; evidence about effective approaches to the environmental and lifestyle sources of disease) and art (the healing partnership and the search for insight in the therapeutic encounter). These two cornerstones of clinical medicine must be integrated into our teaching and practice in order to achieve what we owe to our patients and ourselves -- a more effective response to the epidemic of chronic disease. We assert that this can be done.

What is Functional Medicine?

With functional medicine, we begin to define a model of patient care that seeks to identify underlying chronic dysfunctions associated with altered physiological processes and to maximize functionality at all levels of body, mind, and spirit. It first addresses the patient's core clinical imbalances, fundamental physiological processes, environmental inputs, and genetic predispositions. Diagnosis, of course, is part of the functional medicine model, but the emphasis is on understanding and improving the functional core of the human being as the starting point for intervention.

Functional medicine clinicians focus on restoring balance to the dysfunctional systems by strengthening the fundamental physiological processes that underlie them, and by adjusting the environmental and lifestyle inputs that nurture or impair them. This approach leads to therapies that focus on restoring health and function, rather than simply controlling signs and symptoms.

Principles

Seven basic principles characterize the functional medicine paradigm:

  1. Acknowledging the biochemical individuality of each human being, based on the concepts of genetic and environmental uniqueness;
  2. Incorporating a patient-centered rather than a disease-centered approach to treatment;
  3. Seeking a dynamic balance among the internal and external factors in a patient's body, mind, and spirit;
  4. Addressing the web-like interconnections of internal physiological factors;
  5. Identifying health as a positive vitality—not merely the absence of disease -- and emphasizing those factors that encourage a vigorous physiology;
  6. Promoting organ reserve as a means of enhancing the health span, not just the life span, of each patient; and
  7. Functional medicine is a science-using profession.

Environmental Inputs

  • Diet (type and quantity of food, food preparation, calories, fats, proteins, carbohydrates)
  • Nutrients (both dietary and supplemental)
  • Air
  • Water
  • Microorganisms (and the general condition of the soil in which food is grown)
  • Physical exercise
  • Trauma
  • Psychosocial and spiritual factors (including family, work, community, economic status, stress, and belief systems)
  • Xenobiotics
  • Radiation

Fundamental Physiological Processes

  1. Communication
    • outside the cell
    • inside the cell
  2. Bioenergetics/Energy Transformation
  3. Replication/Repair/Maintenance/Structural Integrity
  4. Elimination of Waste
  5. Protection/Defense
  6. Transport/Circulation

Core Clinical Imbalances

Common underlying pathways of disease are reflected in a few basic clinical imbalances:

  • Immune/inflammatory imbalance
  • Energy imbalance/mitochondrial dysfunction
  • Digestive/absorptive and microbiological imbalance
  • Detoxification/biotransformation/excretory imbalance
  • Imbalance in structural, boundary, and membrane integrity
  • Hormonal and neurotransmitter imbalances
  • Imbalance in mind-body-spirit integration

Constructing the Model

  1. Whole body (the "macro" level)
  2. Organ system
  3. Metabolic or cellular
  4. Sub cellular/mitochondrial
  5. Sub cellular/gene expression
The Healing Partnership -- A Synthesis of the Art and Science of Medical Practice

A healing partnership forms to heal the patient through the integrated application of both the art of medicine (insight driven) and the science of medicine (evidence driven). The starting point for creating a healing partnership is the patient's experience: People, not diseases, can heal.

  • Allow patients to express, without interruption
  • After focusing on the main complaint, encourage the patient's narrative regarding their
    present illness(es).
  • Next, convey to the patient in the simplest terms possible that to achieve lasting solutions to the problem(s) for which he/she has come seeking help, a few fundamental questions must be asked and answered in order to understand the problem in the context of the patient's personal life.
  • Explaining the structure of the next step helps the patient participate in a journey of exploration about their illness—and their search for health.

See the Institute for Functional Medicine Resources web page for links to the White Paper and additional resources.