AIMS Implementation

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The Merck Mectizan? Donation Program
River Blindness (Onchocerciasis)
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What is River Blindness?

• A parasitic worm (Onchocerca volvulus) that
  breeds in fast-flowing rivers
• Transmitted by the bite of an infected black fly
• Adult worms produce millions of offspring. The
  offspring move throughout the human body causing
• intense itching (lack of sleep, concentration)
• skin lesions (Leopard skin)
• sight impairment and eventual blindness

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River Blindness Oncho
Black fly
Leopard Skin
Itching
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Nodules
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Effects of the Disease

• Disfigurement, Debilitating, Blindness
• Abandonment of Fertile Plains Near Rivers
• Negative Economic and Social Effects

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Quality of Life Consequences

• Life expectancy
• blind persons life may be shortened by 13 years
• Productivity
• coffee plantation workers were 15 less
  productive
• forced migration to less fertile lands
• constant, intense itching reduces ability to
  work, study suicide
• School attendance
• child is twice as likely to drop out of school
• girls are affected more than boys
• Social stigmitization
• effects on marriage, social interaction
• Source WHO WHO Expert Committee on
  Onchocerciasis. WHO Technical Report Series No.
  752, WHO, Geneva, 1987

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Where is River Blindness?
Africa - 28 countries
Latin America - 6 countries

• West Africa - 11 countries
• Central Africa - 11 countries
• East Africa - 6 countries

• Brazil
• Colombia
• Ecuador
• Guatemala
• Mexico
• Venezuela

• Middle East - 1 Country
• Yemen

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Worldwide Burden of Disease

• 18 million people infected world-wide
• 80 - 120 million people at-risk for infection
• A leading cause of blindness
• 270,000 blind
• 800,000 visually impaired
• 9 million people with significant skin disease
• 99 of disease in Africa

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Development of Mectizan

• 1975 - evaluation of soil samples from Japan
  produced sample with surprising antiparasitic
  activity
• 1978 - sample evaluated in animals - effective
  against Onchocerca cervicalis, closely related to
  O. volvulus (microfilarie that causes human river
  blindness)
• 1978/79 - Dr. Roy Vagelos, head of Merck
  Research, approves continued research
• 1981 - 7 years of clinical trials in humans begin
• 1987 - Decision made to donate Mectizan

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What is Mectizan??

• an antiparasitic derived from the avermectins
• the first well-tolerated and effective medicine
  for community-wide treatment of onchocerciasis
• works by paralyzing the microfilariae that cause
  itching, skin lesions, sight impairment and
  eventual blindness
• can prevent blindness and slow production of new
  microfilariae for up to one year
• effective with one annual dose

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Commitment

• Recognizing that Mectizan was an advance in
  medicine needed by large populations
• Recognizing that the target population could not
  afford to pay for the medicine at any price
• Merck announced in October 1987 that it would
  donate Mectizan for as long as needed, wherever
  needed to eliminate onchocerciasis (river
  blindness) as a public health problem

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Challenges

• River Blindness is primarily a rural disease
• Weak infrastructure / lack of resources
• Political and civil unrest
• Logistics
• drug importation and distribution problems
• Distribution sustainability
• Competing public health priorities
• River blindness not a top health care priority

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Mectizan Expert Committee (MEC)

• Independent committee of experts for application
  review and approval
• Established and fully funded by Merck
• Comprised of Chairperson and 6 experts in
  tropical disease, ophthalmology and/or public
  health
• WHO, World Bank, CDC, Merck, APOC, OEPA, NGDO
  Group serve as non-voting liaison members

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Role of the MEC

• Develop application procedures and guidelines to
  assure responsible use and distribution of drug
• Review applications for Mectizan for
  community-based treatment programs
• Review program strategies operations, capacity
  skills of program staff and ability to deliver,
  administer Mectizan
• Advise requesting governments, organizations and
  assist in establishment of treatment programs
• Monitor progress of treatment programs and
  overall program

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The Mectizan? Donation Program Partnership
Mectizan Expert Committee/ MDP (Atlanta)
Local Communities
World Health Org.
River Blindness
Non-Governmental Organizations
Merck
World Bank
Local Health Care Workers
Local Ministries of Health
Donor Community
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Evolution of Distribution

• ? Prevention of Blindness NGDOs
• Mobile teams treat communities
• ? Ministry of Health NGDOs
• NOTFs partnerships between all stakeholders
• ? Community Directed Treatment with Ivermectin
  (CDTI)
• Community management/ownership

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CDTI Principles of Mectizan Distribution in
RuralAfrican Communities

• Community involvement in design of distribution
  systems
• Flexibility as indicated by local conditions,
  needs, experience
• Availability of Mectizan from central source
• Availability and selection of credible
  distributors
• Leadership to facilitate effective functioning of
  distribution system
• Integration with the local health system
• Social and political stability of the community
• Perceived benefits of Mectizan
• Availability of local resources to maintain system

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CDTI -- Testimonial (Cameroon)
The head of a health center used to go for
immunization in the villages of his health area.
When he arrives in a village, he waits in front
of the Chiefs house for the parents to bring the
children for immunization. He would wait a whole
day only to vaccinate 20 children, and thus spent
more than 15 days to cover his health area to
obtain a treatment coverage of 23. Today,
with the implementation of CDTI in the province,
the same nurse obtains a treatment coverage of
almost 61. He arrives in a village, contacts
the community distributor who is in charge of the
census register and then goes from one household
to another where there are children aged 0 to 5
years. In one day, he can make a round of 10
villages Source WHO Year 2001 Progress
Report - APOC
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Worldwide Effort

• Onchocerciasis Control Program (OCP)
• 11 West African countries
• African Programme for Onchocerciasis Control
  (APOC)
• 17 sub-Saharan countries outside of W. Africa
• Onchocerciasis Elimination Program of the
  Americas (OEPA)
• 6 countries in Latin America

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September 2002 The Village of Bombani

• Mectizan Donation Program, after 15 years, is
  reaching over 30 million people annually in 33 of
  35 endemic countries
• In September -- in the remote village of Bombani,
  Tanzania -- program experts, health leaders, the
  VP and MOH of Tanzania and Merck CEO Ray
  Gilmartin gathered to administer the 250
  millionth dose of Mectizan
• A local crowd of more than 2000 gathered to
  commemorate this milestone event

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Results To Date

• Active programs in 33 of 35 endemic countries
• More than 30 million persons treated annually
• More than 250 million cumulative treatments since
  1987
• More than 850 Million tablets donated since
  inception

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Benefits to Society

• Control of Onchocerciasis as a Public Health
  Problem
• Prevention of Blindness
• Improved Health
• Strengthened Health Systems
• Improved Environment for Economic Development
• Enhanced Social Environment

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Accomplishments

• Direct Health Benefits
• OCP -- Number of infected near zero 1.5 million
  who were infected no longer have trace of disease
• 40 million people protected from disease 18
  million children spared risk of infection in W.
  Africa
• 600,000 cases of blindness prevented by 2002
• Within 5 years in APOC countries, 40,000 cases of
  blindness prevented annually (WHO, 2001)
• 80 reduction in new cases of optic nerve
  disease
• Source Benton (2001), The Onchocerciasis
  (River Blindness) Programmes Visionary
  Partnerships, World Bank Africa Region, Findings
  No. 174 (January)
• Source Annals of Tropical Medicine
  Parasitology APOC at Mid-Point, March 2002

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Accomplishments

• Direct Health Benefits (continued)
• 45 reduction in incidence of further visual
  field deterioration in individuals with optic
  nerve atrophy
• 50 decline in prevalence of severe itching
  improvements in reactive skin lesions
• Distribution / Infrastructure
• CDTI increased coverage, community ownership,
  enhanced community responsibility
• 61,000 communities involved in planning
  managing Mectizan distribution
• 89,000 community distributors trained in Mectizan
  administration
• Source Annals of Tropical Medicine
  Parasitology APOC at Mid-Point, March 2002
• Source WHO Year 2001 Progress Report on
  APOC(CDTI - Community-directed treatment with
  ivermectin)

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Accomplishments

• Distribution / Infrastructure (continued)
• Evidence-based, participatory, use of
  pre-existing health structure and personnel
• First time health intervention involving mass
  treatment is being successfully directed by
  communities
• Duplication of activities avoided, use of limited
  resources optimized.
• Impact on Health Systems
• General strengthening of health systems in remote
  areas
• Helped MOHs in 14 APOC countries to build
  administrative and technical capacity in health
  delivery
• of communities receiving health education has
  increased from 18,616 (1996) to 49,000
  communities (2000)
• Source Annals of Tropical Medicine
  Parasitology APOC at Mid-Point, March 2002

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Accomplishments

• Impact on Health Systems (continued)
• 67,188 CDD and 13,795 health workers trained in
  community mobilization, census taking, dosing,
  managing side effects, record keeping and drug
  stock management
• Development of innovative approaches to health
  education
• Training -- most visible and enduring
  achievement
• Transportation facilities made available for
  Mectizan distribution have supported other
  programs
• Local capacity-building in drug stock management,
  supervision of distribution and handling of
  adverse effects
• Source Annals of Tropical Medicine
  Parasitology APOC at Mid-Point, March 2002

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Accomplishments

• Social Economic Impact
• 25 million hectares of land freed within OCP
  region -- enough to feed 17 million people
• Investments in programs yielded economic returns
  of nearly 20 primarily from increased
  agricultural output
• APOC currently undergoing assessment
• Partnership
• Sustenance of diverse web of interactions of
  partners
• Strengthening of collaboration at national level
  (NOTFs) and among national and international
  partners in support of health development beyond
  oncho control
• Source Benton (2001), The Onchocerciasis
  (River Blindness) Programmes Visionary
  Partnerships, World Bank Africa Region, Findings
  No. 174 (January)
• Source Hopkins Richards (1997), Visionary
  Campaign Eliminating River Blindness, Medical
  and Health Annual, Chicago, IL Encyclopedia
  Britannica.

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Accomplishments

• Other Accomplishments
• Integration of delivery of Mectizan into primary
  healthcare systems
• CDTI as entry point for other health services
• Johns Hopkins-Bloomberg School of Public Health
  Impact Study
• Targeted release Fall 2003
• Source Annals of Tropical Medicine
  Parasitology APOC at Mid-Point, March 2002

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Impact.much more than River Blindness

• Multi-sectorial partnership of organizations and
  communities with critical comparative advantages
• Empowering communities to manage their own
  well-being and enhance medical access (through
  CDTI)
• Avenue for diagnosing / treating additional
  diseases
• Vitamin A deficiency, Malaria, Cataract,
  Trachoma, LF, Polio immunization, nutrition and
  water protection (Source WHO Year 2001 Progress
  Report APOC)
• Providing critical census information for
  regional/national health care planning
• Integrating drug delivery into national health
  system

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Lessons Learned

• Focus resources on feasible targets of clear
  public health significance
• Importance of partnerships among private and
  public sector organizations to control a dreadful
  disease
• Essential role of distribution mechanisms and
  healthcare infrastructure in ensuring that
  medicines like Mectizan get to those who need
  them

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Lessons LearnedPartnerships

• Complexity of the issues beyond the ability of
  any single organization or country alone
• Based on principle that people most directly
  affected should determine their own needs and
  priorities
• Based on clear objectives, trust, transparency,
  complementary expertise and mutual benefit
• Continuing need for coordination, communication
  and commitment from all stakeholders

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Lessons Learned Infrastructure and
Sustainability

• Cost is not the only barrier to care and
  treatment -- without adequate infrastructure
  medicines do not reach the people who need them
  most
• Commitment to sustainability is as critical as
  promise to supply product
• Importance of integration into a countrys
  healthcare system

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The Mectizan Donation ProgramA Model for
Broader Health Interventions

• Donation programs as one mechanism for improving
  access to care and treatment
• MDP as a model
• Pfizer and the International Trachoma
  Initiative GlaxoSmithKline and lymphatic
  filariasis African Comprehensive HIV/AIDS
  Partnership
• Even when medicines are free, access depends on
  infrastructure, distribution, logistics,
  partnership and sustainability

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1998 Merck Announces a Major Expansion of its
Mectizan? Donation Program

• to include the prevention of lymphatic filariasis
  (LF), or elephantiasis, within Africa where
  onchocerciasis and lymphatic filariasis co-exist
• an estimated 300 million Africans are at risk of
  LF
• to use experience gained from the river blindness
  program to effectively attack, and hopefully
  halt, the transmission of LF

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MDP Lymphatic Filariasis

• Collaboration with GSK, WHO, other organizations
• In Africa Utilizing same system developed for
  onchocerciasis treatment
• Year-End 2002 15 million people in 8 African
  countries treated

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Bringing Hope in Sight