Lee Hyejung, KMD, Ph.D President of Korea Institute of Oriental Medicine

October 22, 2017

2017 Taiwan Global Health Forum

1

Table of Contents

Introduction to Integrative Medicine 02

Integrative Medicine for Elder Care 03

R&D Strategies for IM 04

KIOM Strategies for Elder Care 05

Overview of Aging Issues in S. Korea 01

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3

Korea's population is aging rapidly

- There are 6.6 million people aged over 65 years, representing 13.2% of the population in

2015. This number is expected to reach 40.1% in 2060 (Statistics Korea, 2016).

- Korea's total birthrate was 1.25 in 2016, which is the lowest among the OECD members.

※ The total birthrate refers to the average number of children that a woman has or chooses to have over her lifetime

Aging Korea

4

Unpleasant Paradox of Aging in Korea

Longevity

Fragile

health (disease

burden)

Poverty (medical cost

burden)

5

Rapid increase in life expectancy in S. Korea

- By 2030, Korean women can expect to live to 91 years of age. Korea is likely to become the

first country where life expectancy will exceed 90 years.(Nature, 2017)

Source: Am J Public Health, 2010

Korean men

Korean women

Long life

6

Elderly in poverty

- S. Korea has the highest poverty rate for elderly citizens

among the OECD members

※ Almost half (48.6%) of South Korea’s population over 65 years lives

in relative poverty (the Guardian, 2017).

- S. Korea has one of the lowest net pension replacement rates

(45.2%), falling well below the OECD average of 65.9%

- An estimated 74% of poverty-stricken elderly Koreans live alone

- Many seniors decide to take their own lives to avoid becoming a burden to their families

※ High levels of isolation and depression have led to a dramatic rise in elderly suicide

No family support

Poverty and Social Exclusion

(source: the Guardian, 2017)

S. Korea USA Japan OECD

< % of elderly poverty, 2010 >

(source: OECD, 2011)

7

Disease burden in the elderly population

- Older adults are at high risk for developing illnesses.

- Major health concerns for seniors include:

• Dementia and mental health concerns

• Diabetes and obesity

• Heart disease

• Cancer

- Elderly medical expenses accounted for 36.8% in 2015.

- The annual per capita medical cost by elderly (₩3,433K) is 3-fold larger than the average

(₩1,150K)

Source: Korean Journal of Pediatrics, 2002

Injury

Muscular-skeletal disease

Digestive disease

Respiratory disease

Cardiovascular disease

Neuro-psychiatric conditions

Diabetes

Cancer

<Cause of prevalent disease by age group in Korea>

Pre

va

len

t p

er

10

0,0

00

Fragile Health Condition

(Source: National Health Insurance Korea)

Medical

expenses Medical expenses

for elderly over age 65

medical expenses, Per

Capita,

by elderly over age 65

(Unit: ₩, hundred million)

(Unit: ₩, thousand)

Average annual

medical expenses for

65+ in S. Korea

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Aging is a multidimensional process encompassing all aspects of the mind

and body

Integrative medicine (IM) may be an

appropriate solution to prevent many diseases

related to aging - it considers all factors that influence health, wellness and

disease, coupled with body, mind, spirit and community

IM helps improve quality of life for aging

individuals

Integrative Medicine is the Solution

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Origin of Integrative Medicine (IM)

Origin of Integrative Medicine

- Originally, the term IM was born in an attempt to develop an educational course, “The

Program in Integrative Medicine” at the Univ. of Arizona. As part of the program, the

“Integrative Medicine Clinic” was established for the first time in 1994. (Tracy W., 1998)

3100 BC 2500 BC

Egyptian medicine

Ayurveda, Unani medicine

1600 BC

Traditional Chinese Medicine

800 BC

Greek medicine

Roman medicine

27 BC

Arabic medicine

622 AD

Thoth, ancient Egyptian god often depicted as an ibis-headed man.

Front cover of the book “The Nectar of Instruction 1st edition” by A.C. Bhaktivedanta Swami

Yin Yang Symbol

Hippocrates

Muhammed ibn Zakariya al-Razi

Western medicine

17th AD

Integrative medicine

20th AD

(Pan W. et al., 2013)

(Richard P et al., 2015)

History of Medicines

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What is Integrative Medicine ?

Current definition of IM

The practice of medicine that reaffirms the importance of the relationship

between the practitioner and patient focuses on the whole person, is

informed by evidence, and makes use of all appropriate therapeutic

approaches, forms of healthcare and disciplines to achieve optimal health

and healing

(Developed and Adopted by The Consortium, May 2004 Edited May 2005, May 2009 and November 2009)

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“Integrative” vs “integrated”

- In Europe, it is called ‘integrated’ medicine and in the US ‘integrative’ medicine

“Alternative” vs “Complementary” vs “Integrative”

- Alternative medicine

Instead of, or at the exclusion of, conventional approaches (currently for non-evidence based approaches)

- Complementary medicine

alongside with, or as an adjunct to, conventional approaches (collaborative)

- Integrative medicine

combining CAM, traditional, and conventional approaches in synergy

(combines all medical therapies, using optimum evidence and optimum research methodology)

Terminology Differences

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In fact, there is no standard IM definition

- It differs among countries, practitioners and scientists depending on medical

practices or cultural backgrounds.

- There are debates over what integrative care is and the nature of the

transformation of service.

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Difference by Country

In China, IM always refers to the Integration of TCM and WM (ITCWM)

- ITCWM is actively practiced in Chinese medicine departments in Western medicine-based

hospitals, all departments of Chinese medicine hospitals, and departments of IM hospitals

for various conditions

The integrative healthcare system in China was purposely created by Mao Zedong in 1956 “to integrate

the knowledge of Chinese medicine with the knowledge of Western medicine and pharmacology, to

create unique new medicine and pharmacology”

Conventional medicine

J Integr Med. (2013) 11(2):135-139

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Difference by Medical Providers

Difference in Viewpoints b/w KM and WM stakeholders

- (KM stakeholders) IM makes use of all of the advantages of current medicines on the

basis of KM (IM is the concept of the expansion of KM’s medical boundaries)

- (WM stakeholders) IM combines conventional mainstream practices with CAM

Complementary

medicine

Western

medicine

“supportive”

“collaborative”

Korean

medicine

Western

medicine

Other traditional

medicines Complementary

medicine

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General Characteristics

Patient-centered

Selective

Holistic

Natural

Disease is understood to be the result of physical, emotional, spiritual, social and environmental imbalance. Therefore, healing takes place naturally when these aspects of life are brought into proper balance.

IM customizes treatment recommendations and decision-making in response to patients’ preferences and beliefs. IM focuses on physical, psychological, spiritual,

social and lifestyle issues.

IM provides a greater range of therapeutic options to patients.

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Principles of IM

Donald Berwick a former Administrator of the Centers for

Medicare and Medicaid Services.

President and Chief Executive Officer of the

Institute for Healthcare Improvement

1. Place the patient in the center

2. Individualize care

3. Welcome family and loved ones

4. Maximize healing influences within care

5. Maximize healing influences outside of care

6. Rely on sophisticated, disciplined evidence

7. Use all of the relevant capacities—waste nothing

8. Connect helping influences with each other

Berwick’s Model

(Source: Topics in Integrative Health Care, 2010)

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Patients and practitioners are partners in the healing process

IM depends on a partnership between the patient and doctor, where the goal is to treat the mind, body, and spirit at the same time.

All factors that influence health, wellness, and disease are taken into consideration, including mind, spirit, and community, as well as body. Patients want to be considered whole human beings in the context of their world.

Appropriate use of both conventional and alternative methods (KM, CAM) facilitates the body’s innate healing response. IM recognizes the body’s profound healing mechanisms and seeks to mitigate barriers to healing by using nutrition, activity, mind-body medicine, and where appropriate, conventional and alternative therapies

Effective interventions that are natural and less invasive should be used whenever possible. IM orders therapies ranking those that have the greatest potential for benefit with the least potential for harm first (acupuncture, nutrition, exercise, etc.)

Good medicine is based on good science. It is inquiry-driven and open to new paradigms Practical and pragmatic research models that evaluate systems of care and investigate the interaction of multiple health influences are needed.

Practitioners of integrative medicine should exemplify its principles and commit themselves to self-exploration and self-development

Alongside the concept of treatment, the broader concepts of health promotion and prevention of illness are paramount. IM addresses the mind, body, and spirit with an emphasis on supporting balance, maintaining health, and promoting longevity

Integrative medicine neither rejects conventional medicine nor accepts alternative therapies uncritically

Weil’s Model

Andrew Weil Clinical professor of medicine

at the University of Arizona

Principles of IM

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20

Advanced

Cost-effective

Integrative

Medicine

IM is Balanced

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Why… IM for Elder Care ? (1/4)

The elderly often suffer from a mixture of acute and chronic medical

problems as well as functional disabilities.

Most seniors have a past medical history and presenting conditions

※ The elderly usually present multimorbidity due to chronic illnesses that are intermittently

aggravated by acute disease and exacerbated by pre-existing chronic illnesses

※ Approximately 80% of all people aged >65 years in the U.S. have at least one chronic condition,

and 50% have 2 or more (Ageing Res Rev, 2011)

-IM combines state-of-the-art conventional medicine with safe and effective

complementary therapies that are carefully selected.

-IM team care is provided by interdisciplinary collaboration in an attempt to

find the best combination of therapies for the needs of the elderly

IM offers a comprehensive, evidence-based, team-based, and well-

coordinated healthcare modality.

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IM offers gentler and safer approaches to address common health

conditions of seniors

-

The elderly are more susceptible to pharmaceutical adverse effects than

the younger population.

Seniors suffer more from side effects and complications, in part

because of their poor metabolism or excretion ability.

The health status of elderly individuals changes frequently and

dramatically, with those receiving care today potentially not receiving it

in the subsequent year, and vice versa.

- IM combines non-pharmacological or less invasive interventions when

appropriate.

Why… IM for Elder Care ? (2/4)

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IM offers patient-centered care

Healthcare providers are certainly aware of the differences between

medical problems of the young and old.

- Distinguished medical interventions for older patients are often ignored,

leading to inappropriate or incomplete treatment.

Older people are consistently excluded from clinical trials, even though

they are the largest users of approved drugs

Older patients deserve respect, but are neglected in reality.

- IM pursues optimized healthcare by treating patients with respect, courtesy,

and dignity

- Individual preferences and values are factored into the care plan, and all care

is aligned with patient preferences.

Why… IM for Elder Care ? (3/4)

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IM is actually “cost-effective”

- IM approaches can decrease the use of medications, resulting in substantial cost

savings for hospitals in regard to patient care.

※ Cost savings are achieved by reducing hospitalization and lowering the use of expensive medical

interventions. Instead, IM facilitates mind-body therapies, exercise, and nutritional approaches.

S. Korea has had the highest senior poverty rate in terms of income

among OECD member countries for several years

Cost is the most important factor in selecting medical options for the

elderly

(source: BJM Open, 2017) (source: EXPLORE: The Journal of Science and Healing, 2010)

Why… IM for Elder Care ? (4/4)

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Opportunities for IM for Elder Care

WE

LL-T

IME

D

INNOVATIVE

The conventional health care system is in crisis

IM is an innovative medical paradigm

IM use is constantly rising Older people are in favor of non-conventional

medicine (ex. Korean Medicine)

Senior dissatisfaction with

conventional medicine led to

the rise of IM approaches to

healthcare

The medical paradigm is shifting

from treatment-centered therapy

to disease prevention-centered

therapy.

68.7% of the population aged 60

and over use KM therapies in S.

Korea (BMC CAM, 2017)

69% of S. Koreans have received

KM, and those who receive both

WM and KM are currently

increasing in numbers

EMERGENT

EN

CO

UR

AG

ING

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Common Barriers of IM Practice

• “The vast majority of studies have shown IM to be no different from placebo.”

(Tom Delbanco, MD, a Harvard Medical School professor)

• Many people have the impression that IM creates substantial add-on costs

Skeptical or negative attitude

toward IM

Not enough standardization

Not enough scientific evidence

• The absence of a standardized terminology and lack of a shared conceptual

framework is problematic.

• Due to differences between countries and manuscripts published in different

languages, extensive work is required to identify search terms and synthesize

findings

• The study of IM is costly, time-consuming, and methodologically challenging

(Maizes et al, 2002)

• Aging results from a number of causes. Despite extensive research, there is

no way to prevent aging.

• Many seniors use dietary supplements concurrently with medications. There

are raising concerns about harmful drug interactions.

Not enough collaboration

• Little collaboration occurs between conventional- and non-conventional

practitioners

• Building trust and acknowledging different approaches are central to IM

practice

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Arnold S. Relman

Former editor-in-chief emeritus of the New

England Journal of Medicine

Professor emeritus of medicine and social

medicine at Harvard Medical School

Andrew Weil Clinical professor of medicine

at the University of Arizona

“IM is not an advance, but a return to the past. I cannot

see how such an integration, even if it were possible,

would improve medical care or further the cause of human

health. Most alternative systems of treatment are based on

irrational or fanciful thinking and false or unproven factual

claims. Their theories often violate basic scientific

principles and are at odds….”

“In this country and throughout the world, patients in

unprecedented numbers are going outside of conventional

medicine to look for help. Why are people doing this?

Clearly, there is dissatisfaction with conventional medicine.

Dr. Relman has dismissed whole fields of medicine and

thousands of years of cultural tradition, such as Chinese

medicine….”

A Debate Between Arnold S. Relman and Andrew Weil

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Strengths Weaknesses

Opportunities

Threats

Finding robust scientific

evidence

Standardizing diagnostic

criteria

Establishing a definite

concept for IM

Standardizing R&D eligibility

criteria

Setting priorities for the IM

research agenda

Optimizing the appropriate

IM research framework

SWOT Analysis (General IM strategies)

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① Establishing the IM Definition

Establishment of a Concept for Integrative Medical Treatment

- It is necessary to reach an agreement on a conceptual definition of IM

- A consensus concept is essential for IM development

R&D Strategy for Elder Care

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② Setting Priorities for Research Agenda

Prioritization criteria should be established and addressed due to limited

R&D resources.

Considerable elements to determine the IM research priority

Those that impose a heavy burden of suffering on individuals, families or the community either because of their

severity

chronicity

prevalence

And for which current mainstream therapies are unacceptable or insufficient because of

lack of proven efficacy

substantial side effects

cost

lack of availability

And for which integrative health offers a reasonable likelihood of being helpful based on

proven safety in animal models

lengthy historical use or compelling results from case reports, case series, epidemiologic studies, case-control trials or cohort studies, or clear scientific rationale

And for which widespread use by families and/or clinicians already occurs.

Criteria for conditions, diseases, and risky health behaviors with a high priority for integrative

health research (Explore 2010; 6:143-158)

R&D Strategy for Elder Care

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Quantity and quality of available preliminary data to facilitate determination

Public health importance of the disease being treated

Cost of research

Extent of use by the public

Appropriate type of research (low complexity of design, repeatability of the research design, availability of the clinical research infrastructure, etc.)

(widespread and enduring use by large segments of the population)

Recommended IM research criteria

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Documentation and description of an unconventional treatment

Preliminary evaluation of safety and efficacy on a small group of subjects with a defined indication

Comparative evaluation of safety, effectiveness and transferability

Research on the efficacy and mechanism of action

Surveillance after acceptance in anew clinical setting either as an additional option for patients or an integrated part of conventional clinical practice

(Surveys, case studies or review of the available literature)

(Observational, prospective, pragmatic pilot study)

(Pragmatic multicenter RCT versus conventional treatment or no treatment)

(Explanatory RCT, basic science research)

(Long term follow up, pharmacological surveillance, risk-benefit studies)

③ Optimizing the Research Framework R&D Strategy for Elder Care

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- Rational sequences of IM research are different from conventional and traditional medicine.

Step Conventional medicine Traditional medicine Integrative medicine

(1) Strong physio-pathological basis (‘‘it could work’’)

Widespread and enduring use in clinical practice (‘‘it seems to work’’)

Strong requirements for consideration of complete safety, efficacy and better cost—benefit (‘‘it needs something to work better’’)

(2) Evaluation of safety and efficacy (‘‘does it work in experimental settings?’’)

Pragmatic evaluation of safety and effectiveness (‘‘does it work in clinical practice?’’)

Comprehensive evaluation of safety and efficacy in synergy (‘‘does it work better in experimental settings?’’)

(3) Introduction in clinical practice; evaluation of effectiveness (‘‘does it work in clinical practice?’’)

Evaluation of efficacy; research on the mechanism (‘‘Does it have specific actions? why and how does it work?’’)

Introduction in clinical practice; evaluation of effectiveness (‘‘how effective is it in whole person care?’’)

(Modified from Cardini F. et al., Complementary Therapies in Medicine (2006) 14, 282—287

Difference in the rational sequence between IM and Western medicine

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④ Finding Robust Scientific Evidence

- It is particularly important to illuminate which therapy helps and which does not

- Even identifying which one does not work can be valuable.

UCSC Research showed that saw palmetto did not improve benign prostate hyperplasia, a noncancerous enlargement of the prostate gland. More than 2 million men in the U.S. take saw palmetto as an alternative to drugs. (The New England Journal of Medicine)

- Develop a leading medical treatment technology that overcomes the limitations of IM

practice and research

- Cutting-edge technology helps to better understand the comprehensive effects of integrative

therapies.

Searching for solid evidence is key

Application of advanced medical technology

R&D Strategy for Elder Care

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⑤ Standardizing IM R&D Approaches

Research evidence of the effectiveness of IM should be built using a

standardized methodology and implemented using formal terminology

- Scientists should develop protocols to guide collaborative practices among different types of

practitioners and clarify their respective roles and responsibilities

- Single or shared clinical recording guidelines for accurate and rigorous reporting.

- Standardized clinical/critical pathways should be developed in each practice setting.

R&D Strategy for Elder Care

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KIOM (Korea Institute of Oriental Medicine)

KIOM: A government-supported research institute as a KM R&D hub

1994 Established in Seoul, S. Korea

2004 Moved to Daejeon, S. Korea

2009 Constructed the Guam-building(Laboratory)

2011 Designated as WHO Collaborating Centre for Traditional Medicine

2012 Established Korean Medicine Standard Center

2015 Establishment of KM Application Center in Daegu, S. Korea

KIOM History

Main functions - R&D on KM and establishment of infrastructure for KM technologies - Implementation of its role as a national stronghold for KM

Development of herbal medicine for aging-related diseases

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Development of KM-

based prevention and

management system of

diseases

Development of drugs

for the prevention and

treatment of geriatric,

chronic, and intractable

diseases

Establishment of evidence for

the efficacy and safety of KM

clinical practice

Illumination of the

scientific basis of

KM theories and

principles

Procurement of KM

knowledge resources for its

practical utilization

Technology development

for disease prevention

and treatment for

centenarians

Technology development

for promotion of the value

of KM demands in the

clinical field

Establishment and

implementation of

sustainable KM

healthcare services

KIOM R&D Strategies & IM Assignments

KIOM’s particular R&D approach KIOM R&D

strategy

Research and development for the concomitant administration and combinatory effects of herbal and WM

IM’s Infra-Establishing Research for Acquiring Evidence on Postoperative Care

Related assignments

Development of sophisticated

technology for further

utilization of medicinal herbs

Procurement of KM

knowledge resources for its

practical utilization

Technology

development for

securing herbal

medicinal

resources

Development and mechanistic studies of herbal medicine for senile cognitive disorder improvement

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Development of herbal medicine for aging-related diseases

•Development of drugs for skin aging control

•Efficacy evaluation of herbal medicine for NAFLD (nonalcoholic fatty liver disease)

•Research on biological activity based on the mode of action

Technology transfer

Upfront 260,000$

Running 3.3%

NOVAKMED (subsidiary company)

NOVAREX (mother company)

41

Development and mechanistic studies of herbal medicine for senile cognitive disorder improvement

• Tremendous demand to cope with the expansion of the drug market for senile cognitive disorders

owing to the aging society

•Development of KM-based drugs for senile cognitive disorders, such as Alzheimer’s disease

• MoA (Mode of Action) identification of KM for senile cognitive disorders

Inhibition of amyloid-β

aggregation

Neuroprotective effect Ameliorating effect on

memory impairment

Neuronal marker expression in

Alzheimer’s disease animal model

In vitro In vivo

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Integrative Medicine Infra-Establishing Research for Acquiring Evidence on Postoperative Care

•Clinical evaluation of IM clinical studies for postoperative care

•Development of clinical pathways for IM based on KM and WM

•Efficacy evaluation of KM for postoperative care

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Research and Development for Concomitant Administration of the Combinatory Effect of Herbal and WM

•Symptom relievers, such as common cold drugs, have been prescribed by both WM

and herbal doctors in Korea. Unfortunately, the best case scenarios have not been

studied due to concerns about the harm or risk caused by herb-drug interactions.

•The KIOM challenges the beneficial side of herb-drug interactions, such as the synergy

or sparing effect, which are worthy of study under the country’s guidelines of fixed-dose

combinations.

• Herbal medicine, but not MTX, showed distinctive inhibitory

activities toward TNF-alpha, IL-1, and PGE2.

• They could be presented as independent mechanism

between the two. • The optimal combination ratio and dose range were

found

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Holistic

Therapies

Energy

Medicine

Alternative

Medicine

Korean

Medicine

Complementary

Medicine

Manipulative

Therapies

Surgery

Functional

Medicine

Pharmaceutical

Drug Mind/body

Medicine

IM is Real Advanced Medicine

Thank you! Hyejung Lee

hjlee@kiom.re.kr

+82-42-868-9402