Transcript 050614iks - Amazon Web Services

Indigenous Knowledge Systems [Health]
Medical Research Council – South Africa
Dr Motlalepula G. Matsabisa
Portfolio Committee of Science and Technology Presentation
June 14th 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 Programme
Director Dr MG Matsabisa
IKS Research and
Development
IKS Knowledge
Management
Clinical Trial Platforms
Drug Discovery
Malaria
New
Research Methodology Development
Clinical Trials
Hypertension
Toxicology
Toxicity
HIV and AIDS
Metabolism
New Research Methodologies
Tuberculosis
Drug-Herb Interactions studies
Cancer
Antimutagenicity
studies
Pain Biology
IKS Laboratory
System
studies
Diabetes Genomics
Databases
IKDatabases
Policy
National Reference Centre
Health Promotion
ABS
Tramed
III
Policy
Advocacy
IKS
Research Guidelines
GIS
HealerTDrs
Liaison
IPMonographs
Policy
MCC
– ATMC
Claims
for cures
IKS
Resource
NRCFATM
Centre
Drug targets
Scale up methodologies
Poverty Eradication
Programmes
Special
projects
Pilot Farms
IKS
SBU
Horticulture
Delft
Community Centre
Production GMP
Medicinal garden
Resource centre
TDr Training Program
IKS Production
Facility School
& outreach programs
QC Laboratory
Poverty Alleviation
Proteomics
Metabolomics
IKS Utilization
SBU
DELFT: MRC’s Core IKS Facilities
Manufacturing
Agreements
Signed between TDr, Individuals and MRC on Collaborative Research
Metabolism - UFS
in vitro & in vivo
Breast Cancer
-Gauteng
-Limpopo
Antimalarial
-Free State
-KwaZulu-Natal
Antimutagenicity - UL
in vitro
-Eastern Cape (2)
- North West
Antidiarrhoeal
-KwaZulu-Natal
Anti HIV - NM Med. Sch
in vitro
Antidiabetic
-Gauteng
Traditional Immune Boosters
Anti- TB
-North West
-Gauteng
-- KwaZulu/Natal
-- Gauteng (3)
- Limpopo
International Agreements
Tanzania
Uganda
Nigeria
US, Rutgers University
Kenya
Botswana
India
Antihypertensive
- North West
Approaches in Drug Development
Medicines
– Traditional
Ethno botanical approach – Traditional knowledge
Chemotaxonomic approach
Random screening
Extraction [Hexane, DCM & H2O]
Toxicology testing
Pharmacological testing
Isolation & characterization
Clinical trials
Phase 1 – Phase II/III
[Registration with MCC]
[Manufacturing & commercialization]
Patients
Pharmacological testing
Malaria
 Preclinical studies
In vitro studies
CQ sensitive and Insensitive
MFQ sensitive and Insensitive
Resistance reversal studies
 Clinical studies
Toxicology – Vervet
Efficacy – P. falciparum baboon model
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
Anticancer
MAS3 aqueous
MAS1 aqueous
100
80
HT29
HeLa
MCF7
60
40
20
% Inhibition
% Inhibition
100
0
0.025
0.25
2.5
25
80
60
40
20
0
HT29
HeLa
MCF7
0.025
250
2.5
25
250
micrograms/ml
micrograms/ml
MAS3 methanol
MAS2 aqueous
100
80
HT29
HeLa
MCF7
60
40
20
% Inhibition
100
% Inhibition
0.25
80
HT29
HeLa
MCF7
60
40
20
0
0
0.025
0.25
2.5
25
micrograms/ml
250
0.025
0.25
2.5
25
micrograms/ml
250
Antidiabetic
Toxicity assay on C2C12 muscle
cells
Toxicity assay on Chang liver
cells
0.8
A540nm
A540nm
0.8
0.6
0.4
0.6
0.4
0.2
0.2
0
50
100
0
150
100
150
[Extract] (ug/ml)
[Extract] (ug/ml)
Glucose utilisation in C2C12 muscle cells
Glucose utilisation in Chang liver cells
180
180
120
Acute
100
80
Chronic
60
% of control
160
140
160
140
% of control
50
120
Acute
100
80
Chronic
60
40
20
40
20
0
0
Control
Insulin
Extract
Metformin
Control
Insulin
Extract
Metformin
HIV and AIDS Research
 Assessment of Traditional
Claims for cures
 Safety, Efficacy studies
 Value addition
 Education and Training
 Capacity Development
Traditional Medicines Use in USA
CAM users
40%
None CAM users
60%
General adult population
22%
78%
Use of CAM by PLWA in the USA ( WHO, 2002)
Clinical Evidence for TM
TM as good as
placebo
18%
TM results not
conclusive due to 48%
methodology flaws
34%
TM has benefit better
than placebo
Based on 50 RCTs evaluating 10 TM for 18 indications (Therapeutics Letter, Issue 25, June – July 1998)
Clinical Trials
 Ethics
Ethics: Informed consent for screening

Informed consent for HIV testing

Informed consent for participation in the study

Information leaflet for the screening

Information leaflet for participation in the study
 Counseling:
Integrated approach: To whole family
Pre-screening HIV counseling
1 post screening counseling (referral of those that are
HIV+, but not meeting the inclusion criteria to appropriate
& accredited centres for support)
Ethical approval: (scientific and ethical merits)


Protocols are peer-reviewed
Submitted to MRC & MCC’s Clinical Trials Committee
(CTC) for ethical evaluation
 Toxicology
90-day sub chronic study on a non-human
primate model
 Clinical Human Trials
Both Phase I and II/III
Are double blind, randomized, placebo controlled
dose elevation parallel group studies
IKS Technologies
Systems Biology – Mechanisms of
Action & Drug Targets
R&D Technologies for

Analytical systems

Quality Control

Manufacturing

Proteomics

Genomics

Metabolomics
Drug Metabolism and Drug-herb interactions


Rational Drug Design
Cytochrome P450
1a2
2a
2c19
2d6
2c8
2c9
2e1
3a4
Antimutagenicity and mutagenicity
HIV and AIDS Training
 Training
City Health Department
TB, HIV and AIDS
 School Outreach
 Community Partnerships
 Capacity development
 Medicinal 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 Program
Module 1 - Collaboration, trust and cooperation with traditional healers – Identifying “good” professional
traditional healers
Module 2 - Record keeping, note taking, patient history taking, documentation and follow-ups. – Documentation
Module 3 - Adverse Drug Reaction Reporting Systems – for TDr and Communities
Module 4 - Traditional healers and Home Based Care – care for the elderly and terminally ill, drug abuse,
smoking, alcohol, women and children abuse
Module 5 - Patient Referral System
Module 6 - Traditional Healing, HIV/AIDS (opportunistic infections) and care for the Terminally Sick HIV/AIDS
Sufferers
Module 7 - Principles of Drug Development from Traditional medicines. Assessment of traditional claims for
cures, Benefit-sharing
Module 8 - Assessment of the Training and Compliance
Facts

74% of drugs developed from plants could be attributed to the use of
indigenous plants in traditional medicine by various communities
(Wambembe, 1999).

The annual sales of drugs developed from traditional medicines
amounted to US$43bn out of the US$130 000bn total sales of
pharmaceuticals in the 1980s (Rural Advancement Fund Int. 1997).

Less than 0.001% of profits from plant-based drugs from traditional
medicine knowledge accrued to the people who provided the leads for
the research (Posey, 1991).

Approximately 80% of the rural population use traditional medicines.
Medicinal Trade in South Africa

1988 – 1996
750 plant species used in Traditional Medicines
- 200 very infrequently traded
24 000 sp of plants in SA
4 000 used in Traditional medicines
(used by approx. 12-15 million people)
20 000t medicinal plants traded/year
- US$60million

1996
4300t of wildlife medicinals traded in KwaZulu-Natal US$13.3million

1997
750t traded in Mpumalanga –
US$2.25million
AIM OF THE PROJECT
 Aim
To promote the application of scientific research into
practical implementation of projects oriented to create
permanent sources of income, promote the development of
sustainable enterprises and their integration into the value
adding processes of industrial development and
commercialization of products derived from medicinal
plants.
BACKGROUND
 TARGET: Identified communities with high unemployment rate, and
identified as the poverty nodes by the president. Medicinal plants with
scientifically validated health claims and having existing economic
markets are grown for commercialization.
 Target: Rural women, single run households, orphans and PLWA
INSTITUTIONAL SUPPORT
 Different components in industrial viability
 COMMERCIAL VIABILITY
 TECHNICAL VIABILITY
 INSTITUTIONAL SUPPORT
 ENTREPRENEURIAL VIABILITY

(Alfaro, 2003).
IKS and Competiveness
 The programme is based on the production, industrialization
and commercial development of scientifically validated
medicinal plants as sources of competitive advantages for
entrepreneurial based projects.
 Competitive advantages: BASIC
OPERATIONAL MODEL: Partnerships
Supporting organizations:
Department of Science and Technology (DST)
Department of Health (DoH)
Municipalities and
Private sector.
Established companies
Partner municipalities:
Tsolwana Municipality (Eastern Cape)
Senqu Municipality (Eastern Cape)
Namakhoi Municipality (Northern Cape)
Mbombela Municipality (Mpumalanga)
Makhuduthamaga Municipality (Limpopo).
Anticipated Outputs

Anticipated Impact

Job creation - 200 permanent jobs over 3 years

Sustainable use of medicinal plants

Application of scientific research developed by the IKS Division

Capacity building for institutions (municipalities)

Training and promotion of the culture of entrepreneurship

The promotion of registered business ventures fully owned by emerging entrepreneurs

Horizontal and vertical integration of the area surrounding the projects.
Conclusions
 IKS as a source of competitive advantages
 Export orientation possibility
 Promotion of ownership and empowerment
 IKS as basis for value addition – science base, IK , fauna and flora
Barriers
 Entrepreneurial attitude
 Barriers to entry
 Institutional support
 Long term planning
 Short term solution
 Resource based approach
CAM funding in the USA
USA Funding for CAM
68.3
70
60
50
49.9
40
30
19.5
20
10
0
2
1992
2
1993
4
5.5
1994 1995
7.8
1996
11.5
1997
1998
1999 2000
National Center for Complementary and Alternative Medicines, 2000