Indigenous Knowledge Systems [Health] Indigenous Knowledge Systems [Health]

Medical Research Council – South AfricaMedical Research Council – South Africa

Dr Motlalepula G. MatsabisaDr Motlalepula G. Matsabisa

Portfolio Committee of Science and Technology PresentationPortfolio Committee of Science and Technology Presentation

June 14June 14thth 2005 2005

Our Mission and Vision

To promote and advance indigenous knowledge systems through research and development by making it a valued health model in the global environment and to redress health traditions, which until now have neglected health research priorities and issues.

To be a centre of excellence in traditional medicines research regionally and to be competitive globally

CEO

Research Directorate

IKS Lead ProgrammeDirector Dr MG Matsabisa

IKS Knowledge Management

IKS Research and Development

IKS Utilization SBU

IKS Laboratory IKS Resource Centre

IKS Production Facility & QC Laboratory

DELFT: MRC’s Core IKS Facilities

Drug Discovery

Clinical Trials

Toxicity

New Research Methodologies

DatabasesNational Reference CentreHealth PromotionPolicyAdvocacyHealer Liaison

Poverty Eradication Programmes

Pilot Farms

Horticulture

Production GMP

Malaria

Hypertension

HIV and AIDS

Tuberculosis

Cancer

Pain

Diabetes

IK Policy

ABS

IKS Research Guidelines

IP Policy

MCC – ATMC

NRCFATM

Databases

Tramed III

GIS TDrs

Monographs

Claims for cures

Special projects

IKS SBU

Delft Community Centre

Medicinal garden

Resource centre

TDr Training Program

School outreach programs

Poverty Alleviation

Manufacturing

Clinical Trial Platforms

New Research Methodology Development

Toxicology

Metabolism

Drug-Herb Interactions studies

Antimutagenicity studies

System Biology studies

Genomics

Proteomics

Metabolomics

Drug targets

Scale up methodologies

AgreementsAgreements Signed between TDr, Individuals and MRC on Collaborative ResearchSigned between TDr, Individuals and MRC on Collaborative Research

Traditional Immune Boosters

-Eastern Cape (2)Eastern Cape (2)- North West- North West

-- KwaZulu/Natal- KwaZulu/Natal

-- Gauteng (3)- Gauteng (3)- Limpopo- Limpopo

Antihypertensive

- North West- North West

Metabolism - UFS in vitroin vitro & & in vivoin vivo

Antimutagenicity - UL in vitroin vitro

Anti HIV - NM Med. Sch in vitroin vitro

Breast Cancer-GautengGauteng-Limpopo Limpopo

Anti- TB-North WestNorth West-Gauteng Gauteng

Antidiarrhoeal-KwaZulu-Natal KwaZulu-Natal

Antimalarial-Free StateFree State-KwaZulu-Natal KwaZulu-Natal

Antidiabetic-Gauteng Gauteng

International AgreementsTanzania Tanzania UgandaUgandaNigeriaNigeriaUS, Rutgers UniversityUS, Rutgers UniversityKenyaKenyaBotswanaBotswanaIndia India

Approaches in Drug DevelopmentApproaches in Drug Development – – Traditional Traditional MedicinesMedicines

Ethno botanical approach – Traditional knowledgeEthno botanical approach – Traditional knowledge Chemotaxonomic approachChemotaxonomic approach Random screening Random screening

Extraction Extraction [Hexane, DCM & H[Hexane, DCM & H22O]O]

Toxicology testingToxicology testing Pharmacological testing Pharmacological testing

Isolation & characterizationIsolation & characterizationClinical trialsClinical trialsPhase 1 – Phase II/IIIPhase 1 – Phase II/III Pharmacological testing Pharmacological testing [Registration with MCC][Registration with MCC]

[Manufacturing & commercialization][Manufacturing & commercialization]

PatientsPatients

MalariaMalaria

Preclinical studiesPreclinical studies In vitroIn vitro studies studies

CQ sensitive and InsensitiveCQ sensitive and Insensitive

MFQ sensitive and InsensitiveMFQ sensitive and Insensitive

Resistance reversal studiesResistance reversal studies

Clinical studiesClinical studies Toxicology – VervetToxicology – Vervet

Efficacy – Efficacy – P. falciparumP. falciparum baboon model baboon model

Phase I – Phase IV studies Phase I – Phase IV studies

Resistance Modulators

Cancer

Antibiotics

TB

Malaria – e.g. bis-benzyl alkaloids & CQ

HIV and AIDS – e.g. Acemannan & AZT

Uptake studies & Efflux studies

Non-human models

AnticancerAnticancer

MAS1 aqueous

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HeLa

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HeLa

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HeLa

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Antidiabetic Antidiabetic

Toxicity assay on Chang liver cells

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Toxicity assay on C2C12 muscle cells

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HIV and AIDS ResearchHIV and AIDS Research

Assessment of Traditional Assessment of Traditional Claims for curesClaims for cures

Safety, Efficacy studiesSafety, Efficacy studies

Value additionValue addition

Education and TrainingEducation and Training

Capacity DevelopmentCapacity Development

60%

40%None CAM users

General adult population

CAM users

22%

78%

Use of CAM by PLWA in the USA ( WHO, 2002)

Traditional Medicines Use in USA

18%

34%

48%

TM as good as placebo

TM has benefit better than placebo

TM results not conclusive due to

methodology flaws

Clinical Evidence for TM

Based on 50 RCTs evaluating 10 TM for 18 indications (Therapeutics Letter, Issue 25, June – July 1998)

Clinical TrialsClinical Trials

EthicsEthicsEthics:Ethics: Informed consent for screeningInformed consent for screening Informed consent for HIV testingInformed consent for HIV testing Informed consent for participation in the studyInformed consent for participation in the study Information leaflet for the screeningInformation leaflet for the screening Information leaflet for participation in the studyInformation leaflet for participation in the study Counseling:Counseling:

Integrated approach: To whole familyIntegrated approach: To whole family

Pre-screening HIV counselingPre-screening HIV counseling

1 post screening counseling (referral of those that are HIV+, but not meeting the inclusion criteria to 1 post screening counseling (referral of those that are HIV+, but not meeting the inclusion criteria to appropriate & accredited centres for support) appropriate & accredited centres for support)

Ethical approval: Ethical approval: (scientific and ethical merits)(scientific and ethical merits)

Protocols are peer-reviewedProtocols are peer-reviewed Submitted to MRC & MCC’s Clinical Trials Committee (CTC) for ethical evaluationSubmitted to MRC & MCC’s Clinical Trials Committee (CTC) for ethical evaluation

ToxicologyToxicology

90-day sub chronic study on a non-human 90-day sub chronic study on a non-human primate modelprimate model

Clinical Human TrialsClinical Human Trials

Both Phase I and II/III Both Phase I and II/III Are double blind, randomized, placebo controlled Are double blind, randomized, placebo controlled

dose elevation parallel group studiesdose elevation parallel group studies

IKS TechnologiesIKS Technologies

R&D Technologies forR&D Technologies for

Analytical systemsAnalytical systems

Quality ControlQuality Control

ManufacturingManufacturing

Rational Drug DesignRational Drug Design

Systems Biology – Mechanisms of Systems Biology – Mechanisms of Action & Drug TargetsAction & Drug Targets

ProteomicsProteomics

GenomicsGenomics

MetabolomicsMetabolomics

Drug Metabolism and Drug-herb interactionsDrug Metabolism and Drug-herb interactions

Cytochrome P450Cytochrome P450 1a21a2 2a2a 2c19 2c19 2d62d6 2c82c8 2c92c9 2e12e1 3a43a4

Antimutagenicity and mutagenicity

HIV and AIDS TrainingHIV and AIDS Training

TrainingTraining

City Health DepartmentCity Health Department

TB, HIV and AIDSTB, HIV and AIDS

School OutreachSchool Outreach

Community PartnershipsCommunity Partnerships

Capacity developmentCapacity development

Medicinal Herb GardenMedicinal Herb Garden

MRC Delft Community Project

• Provide enabling environment for healers and scientists to interact

• Formal structure for healers to interact, develop policy and develop communication products

• Provide healers access to scientific infrastructure (Information, Library, Internet access, database, medicinal plant cultivation, drug discovery, Resource Centre)

• Provide a forum for structured health education and promotion (Herb garden)

• Develop skills in growing, processing, packaging and marketing of herbal products

Traditional Healer Training ProgramTraditional Healer Training Program

Module 1Module 1 - - Collaboration, trust and cooperation with traditional healers – Identifying “good” professional Collaboration, trust and cooperation with traditional healers – Identifying “good” professional traditional healerstraditional healers

Module 2Module 2 - - Record keeping, note taking, patient history taking, documentation and follow-ups. – DocumentationRecord keeping, note taking, patient history taking, documentation and follow-ups. – Documentation

Module 3Module 3 - - Adverse Drug Reaction Reporting SystemsAdverse Drug Reaction Reporting Systems – – for TDr andfor TDr and CommunitiesCommunities

Module 4Module 4 - - Traditional healers and Home Based Care – care for the elderly and terminally ill, drug abuse, Traditional healers and Home Based Care – care for the elderly and terminally ill, drug abuse, smoking, alcohol, women and children abusesmoking, alcohol, women and children abuse

Module 5Module 5 - - Patient Referral SystemPatient Referral System

Module 6Module 6 - - Traditional Healing, HIV/AIDS (opportunistic infections) and care for the Terminally Sick HIV/AIDS Traditional Healing, HIV/AIDS (opportunistic infections) and care for the Terminally Sick HIV/AIDS SufferersSufferers

Module 7Module 7 - - Principles of Drug Development from Traditional medicines. Assessment of traditional claims for Principles of Drug Development from Traditional medicines. Assessment of traditional claims for cures, Benefit-sharingcures, Benefit-sharing

Module 8Module 8 - - Assessment of the Training and ComplianceAssessment of the Training and Compliance

FactsFacts

74% of drugs developed from plants could be attributed to the use of 74% of drugs developed from plants could be attributed to the use of indigenous plants in traditional medicine by various communities indigenous plants in traditional medicine by various communities ((Wambembe, 1999Wambembe, 1999).).

The annual sales of drugs developed from traditional medicines The annual sales of drugs developed from traditional medicines amounted to US$43bn out of the US$130 000bn total sales of amounted to US$43bn out of the US$130 000bn total sales of pharmaceuticals in the 1980s (pharmaceuticals in the 1980s (Rural Advancement Fund Int. 1997Rural Advancement Fund Int. 1997).).

Less than 0.001% of profits from plant-based drugs from traditional Less than 0.001% of profits from plant-based drugs from traditional medicine knowledge accrued to the people who provided the leads for medicine knowledge accrued to the people who provided the leads for the research (the research (Posey, 1991Posey, 1991).).

Approximately 80% of the rural population use traditional medicines. Approximately 80% of the rural population use traditional medicines.

Medicinal Medicinal TTrade in South Africarade in South Africa

1988 – 19961988 – 1996 750 plant species used in 750 plant species used in Traditional MedicinesTraditional Medicines - 200 very infrequently traded- 200 very infrequently traded 24 000 sp of plants in SA24 000 sp of plants in SA 4 000 used in Traditional medicines 4 000 used in Traditional medicines

(used by approx. 12-15 million people) (used by approx. 12-15 million people)

20 000t 20 000t medicinal plants medicinal plants traded/yeartraded/year - - US US$$60million60million

1996 1996 4300t of wildlife medicinals trade4300t of wildlife medicinals tradedd in KwaZulu-Natal in KwaZulu-Natal - - USUS$$13.3million13.3million

19971997 750t traded in Mpumalanga750t traded in Mpumalanga – US$2.25million – US$2.25million

AIM OF THE PROJECTAIM OF THE PROJECT

AimAim

To promote the application of scientific research into To promote the application of scientific research into practical implementation of projects oriented to create practical implementation of projects oriented to create permanent sources of income, promote the development of permanent sources of income, promote the development of sustainable enterprises and their integration into the value sustainable enterprises and their integration into the value adding processes of industrial development and adding processes of industrial development and commercialization of products derived from medicinal commercialization of products derived from medicinal plants.plants.

BACKGROUNDBACKGROUND

TARGET: TARGET: Identified communities with high unemployment rate, and Identified communities with high unemployment rate, and identified as the poverty nodes by the president. Medicinal plants with identified as the poverty nodes by the president. Medicinal plants with scientifically validated health claims and having existing economic scientifically validated health claims and having existing economic

markets are grown for commercialization.markets are grown for commercialization.

Target:Target: Rural women, single run households, orphans and PLWA Rural women, single run households, orphans and PLWA

INSTITUTIONAL SUPPORTINSTITUTIONAL SUPPORT

Different components in industrial viabilityDifferent components in industrial viability

COMMERCIAL VIABILITYCOMMERCIAL VIABILITY

TECHNICAL VIABILITYTECHNICAL VIABILITY

INSTITUTIONAL SUPPORTINSTITUTIONAL SUPPORT

ENTREPRENEURIAL VIABILITYENTREPRENEURIAL VIABILITY (Alfaro, 2003).(Alfaro, 2003).

IKS and CompetivenessIKS and Competiveness

The programme is based on the production, industrialization The programme is based on the production, industrialization and commercial development of scientifically validated and commercial development of scientifically validated medicinal plants as sources of competitive advantages for medicinal plants as sources of competitive advantages for entrepreneurial based projects.entrepreneurial based projects.

Competitive advantages: BASICCompetitive advantages: BASIC

OPERATIONAL MODEL: PartnershipsOPERATIONAL MODEL: Partnerships

Supporting organizations:Supporting organizations:Department of Science and Technology (DST)Department of Science and Technology (DST)Department of Health (DoH)Department of Health (DoH)Municipalities andMunicipalities and

Private sector.Private sector.

Established companiesEstablished companies

Partner municipalitiesPartner municipalities::

Tsolwana Municipality (Eastern Cape)Tsolwana Municipality (Eastern Cape)Senqu Municipality (Eastern Cape)Senqu Municipality (Eastern Cape)Namakhoi Municipality (Northern Cape)Namakhoi Municipality (Northern Cape)Mbombela Municipality (Mpumalanga)Mbombela Municipality (Mpumalanga)Makhuduthamaga Municipality (Limpopo).Makhuduthamaga Municipality (Limpopo).

Anticipated OutputsAnticipated Outputs

Anticipated ImpactAnticipated Impact

Job creation - 200 permanent jobs over 3 yearsJob creation - 200 permanent jobs over 3 years

Sustainable use of medicinal plantsSustainable use of medicinal plants

Application of scientific research developed by the IKS DivisionApplication of scientific research developed by the IKS Division

Capacity building for institutions (municipalities)Capacity building for institutions (municipalities)

Training and promotion of the culture of entrepreneurshipTraining and promotion of the culture of entrepreneurship

The promotion of registered business ventures fully owned by emerging entrepreneursThe promotion of registered business ventures fully owned by emerging entrepreneurs

Horizontal and vertical integration of the area surrounding the projects.Horizontal and vertical integration of the area surrounding the projects.

ConclusionsConclusions

IKS as a source of competitive advantagesIKS as a source of competitive advantages

Export orientation possibilityExport orientation possibility

Promotion of ownership and empowermentPromotion of ownership and empowerment

IKS as basis for value addition – science base, IK , fauna and floraIKS as basis for value addition – science base, IK , fauna and flora

BarriersBarriers

Entrepreneurial attitudeEntrepreneurial attitude

Barriers to entryBarriers to entry

Institutional supportInstitutional support

Long term planningLong term planning

Short term solutionShort term solution

Resource based approachResource based approach

2 2 4 5.5 7.811.5

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USA Funding for CAM

1992 1993 1994 1995 1996 1997 1998 1999 2000

CAM funding in the USA

National Center for Complementary and Alternative Medicines, 2000