Partnership Facts
The Lilly MDR-TB Partnership is a unique public-private
health initiative, the aim of which is to gain
control of, and ultimately end, the scourge of
multi-drug-resistant tuberculosis.
As part of this philanthropic initiative, Lilly
has made its manufacturing technology for its
two MDR-TB drugs, capreomycin (Capastat®)
and cycloserine (Seromycin®), available to
pharmaceutical companies in some of the countries
with the highest MDR-TB burdens: China, India,
Russia, and South Africa. As a vital element of
this transfer of technology, Lilly and Purdue
University in the U.S. are working together to
provide training and expertise to help ensure
the quality and sustainability of the manufacture
of these drugs. Lilly has invested in its own
facilities to enable us to double our production
of capreomycin. Lilly is happy to be able to provide
both drugs at a fraction of their cost to World
Health Organization-approved programs around the
world.
Each partner of the Lilly MDR-TB Partnership
seeks to improve health care worldwide by establishing
a model for bringing together public and private
organizations in order to address global public
health threats. A vital aspect of this collaboration
is to engage the involvement and support of private
health care providers. Without this partnership,
tens of thousands more people would become infected
with MDR-TB in the coming years, increasing the
risk of it spreading, as well as the development
of new MDR-TB ”super strains” like
XDR-TB, which have already begun to appear.
Eli Lilly and Company’s partners in the
fight against MDR-TB are:
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Critical Components
of the Lilly MDR-TB Partnership
Increasing drug supply
- Lilly continues to supply both Capastat and
Seromycin at discounted prices to WHO-approved
DOTS-Plus (Directly Observed Treatment short
course, for MDR-TB) programs around the world
through the Green Light Committee. In 2006,
1.2 million capsules of Seromycin and 280,000
vials of Capastat were shipped through the WHO
for distribution to these programs.
- An expansion of Lilly's manufacturing facility
in Speke, south of Liverpool in the United Kingdom,
has allowed us to double our capacity for producing
the capreomycin active ingredient.
- To support this increased capacity, as well
as the growing need for the final forms of both
drugs, Lilly has added sub-contractors—Human
Serum Production and Medicine Manufacturing
Company in Hungary for Capastat, and Vianex
in Greece for Seromycin.
Transfer of Technology
(click
here for a map of existing and future sites)
Lilly has transfer-of-technology agreements
with companies in the four countries with the
highest MDR-TB burdens—South Africa (Aspen
Pharmacare), China (Hisun Pharmaceutical), India
(Shasun Chemicals and Drugs), Russia (SIA International)—as
well as a partnership with Purdue University in
the U.S. In addition to supplying the necessary
manufacturing know-how and expertise to produce
cycloserine and capreomycin, Lilly’s two
MDR-TB drugs, Lilly provides financial assistance
for the purchase of equipment and conversion of
manufacturing facilities, and technical training
for the different steps in the manufacturing process.
These projects are increasing the supply of two
much-needed MDR-TB antibiotics where they are
needed most.
- Aspen
Pharmacare in South Africa sold its first
batch of cycloserine to Botswana in 2005, and
is now producing cycloserine in a brand new
facility with a capacity of 4 billion capsules
per year. Aspen is working with the WHO to begin
supply to countries approved by the Green Light
Committee. Aspen has also begun construction
of a facility to produce vials of capreomycin
by early 2008.
- Hisun
Pharmaceutical in China produced its first
batch of the capreomycin active ingredient in
May 2006. Hisun is also building another facility
to produce vials of the capreomycin final drug.
- Shasun
Chemicals and Drugs dispatched its first
order of cycloserine to Aspen Pharmacare, which
will formulate the drug, in February 2006. Shasun
has also received registration approval for
the cycloserine active ingredient in the U.K.,
and is working with Purdue University to develop
a plan for approval by the U.S. Food and Drug
Administration. Shasun has partnered with a
local hospital and Rotary International to develop
a TB screening program.
- SIA
International is one of Russia’s largest
pharmaceutical companies, and Lilly’s
newest transfer-of-technology partner (since
May 2006). SIA will produce both capreomycin
and cycloserine. After equipment upgrades, production
is expected to start in late 2007.
- Purdue
University in Indiana, USA, assists in the
transfer-of-technology process, and trains partner
companies in good manufacturing and business
practices. Purdue will also produce cycloserine
in its new plant, the Chao Center for Industrial
Pharmacy, in West Lafayette. Purdue has submitted
its official request to manufacture this drug
to the U.S. Food and Drug Administration. Purdue
and Lilly are also working with the government
of Kazakhstan to train drug inspectors in good
manufacturing practices in order to improve
the quality of pharmaceuticals there.”
Lilly has negotiated agreements with the companies
that receive our manufacturing technology, including
limitations on how much these companies may charge
for products to be used in WHO-sponsored programs.
Training, Treatment, and Surveillance
- The
International Council of Nurses (ICN) has
launched a global TB/MDR-TB project to equip
nurses around the world with the knowledge and
tools for detection, treatment, and management
of the disease. ICN has developed “TB
Guidelines for Nurses in the Care and Control
of Tuberculosis and Multi-Drug-resistant Tuberculosis,”
and has established a web-based "Global
TB/MDR-TB Resource Centre” for the 13
million nurses working worldwide. In 2005, ICN
launched its TB/MDR-TB "training of trainers"
program for nurses in South Africa and the Philippines.
ICN has now also implemented the program in
Swaziland, Malawi, and Russia. More than 200
nurses have been trained in these five countries.
The nurses who take part in these programs in
turn train other nurses. ICN has also developed
an anti-stigma toolkit, “TB and Stigma:
A Double Burden.”
- The
International Hospital Federation (IHF)
has developed a comprehensive TB and MDR-TB-control
training manual for hospital managers that will
be disseminated to IHF’s 40,000 public
and private hospital and clinic members. The
goal of the manual is to provide much-needed
support to hospital staff—who not only
diagnose, treat, and manage TB and MDR-TB, but
also need to ensure that patients receive adequate
attention. The manual, which was pilot-tested
in South Africa in 2006, will also serve as
a valuable guide for infection control for patients
and staff, helping to fight a growing health
threat in hospitals and clinics in developing
countries.
- Harvard
Medical School and Partners
in Health (PIH) have established a Center
of Excellence for MDR-TB treatment and training
in Tomsk, Russia. Several hundred doctors, nurses,
and healthcare workers from cities all over
Russia and the former Soviet Union have already
been trained how to prevent, detect, and treat
the illness. New research produced at this Center
is used globally to improve patient management
and clinical effectiveness.
In a milestone achievement, PIH and Russia’s
five Tuberculosis Research Institutes (TBRIs)
have been working together since 2006 to develop
national MDR-TB training standards. PIH has
also established an MDR-TB Advisory Board in
Russia, consisting of public health officials,
international organizations, and members of
academia. Russian doctors have been sent to
the Harvard School of Public Health to participate
in Clinical Effectiveness Programs and learn
more about health care measurement and research
design. PIH is also working on an anti-alcohol
campaign in Russia because alcoholism is a major
factor in non-compliance with the treatment
regimen.
PIH founders Paul Farmer and Jim Yong Kim were
included in U.S. News and World Report’s
2005 list of America’s 25 best leaders
for their vision of how to fight TB, AIDS, malaria,
and other infectious diseases.
- The
U.S. Centers for Disease Control (CDC) has
developed a cutting-edge laboratory information
management system for MDR-TB, which will soon
be implemented in Russia. This new system will
enable counting, monitoring, and reporting of
confirmed TB cases, including drug-resistant
strains, much faster, more easily, and more
accurately than traditional methods. Currently,
30,000 TB lab reports are processed by hand
every year in any given region in Russia. The
system could also be used by other countries
to standardize TB data collection and analysis
methods.
- One of the most critical elements
of tuberculosis management is the World
Health Organization’s (WHO) DOTS-Plus
program (Directly Observed Treatment short course
, for MDR-TB). Under DOTS-Plus, specific policies
and strategies must be in place to ensure the
best possible way to control the spread of resistant
strains and misuse of drugs. This requires a
supervisor to observe the patients taking their
medication for the entire duration of their
treatment. This strategy is the cornerstone
of the global fight against the MDR-TB pandemic.
The WHO helps countries develop national programs
within the approved treatment guidelines by
training health-policy consultants and TB specialists,
and through Drug Resistance Surveillance (DRS)
programs to monitor the evolution and spread
of the disease.
The WHO is a member of the Green Light Committee
(GLC), an independent group of TB experts that
evaluates the quality of DOTS-Plus programs
around the world and provides a platform for
purchasing second-line medicines at reduced
prices. So far, about 26,000 patients have enrolled
in DOTS-Plus programs in 41 GLC-approved countries.
Lilly’s offer of its two MDR-TB drugs
at highly subsidized prices to the WHO and Médecins
Sans Frontières (Doctors Without Borders)
originally facilitated the creation of the Green
Light Committee, and helped the WHO begin implementation
of its DOTS-Plus programs.
The WHO provides technical assistance and training,
including in the appropriate use of antibiotics,
to countries that are developing their own DOTS-Plus
programs. The WHO also helps countries such
as Armenia, Azerbaijan, Russia, the Ukraine,
and Uzbekistan to strengthen their laboratory
capacity.
In 2004, WHO developed software in order to
standardize data collection of patient outcomes
at WHO-approved treatment sites around the world.
Strengthening of data management will help to
improve logistics, training, and drug management
so that WHO can better forecast drug requirements
at treatment sites.
Lilly supports the
Stop TB Partnership’s “Global
Plan to Stop TB”—the goal of which
is to save 14 million people from TB and MDR-TB
by 2015.
- The
World Medical Association is developing
an online MDR-TB learning course for physicians,
available free of charge on the Internet, which
gives doctors around the world access to the
latest international protocols for MDR-TB prevention,
treatment, and management. This Internet course,
which will provide links to relevant international
policy and clinical guidelines, also aims to
facilitate Internet self-study. In addition
to English, the course will also be available
in Spanish, Chinese, and Russian. The WMA is
joined in this effort by the South Africa Medical
Research Council, the Foundation for Professional
Development, and the Norwegian Medical Association,
which will provide accreditation for Continuing
Medical Education (CME).
Community Support, Patient Advocacy,
and Workplace Awareness
- The
International Federation of Red Cross and Red
Crescent Societies (IFRC) implements TB-patient-support
programs aimed at the most vulnerable, such
as homeless people, alcoholics, and drug addicts.
The programs include public awareness and anti-stigma
campaigns, community outreach, psychological
support and food supplements, and are currently
implemented in Kazakhstan, Romania, and, most
recently, Uzbekistan. IFRC volunteers have a
long tradition of working with the most at-risk
population groups in poor countries.
- TB
Alert /TB Survival Project :U.K.-based charity
TB Alert, which is focused on patient advocacy
and creating public awareness of TB, has joined
forces with Paul Thorn, an HIV-positive MDR-TB
survivor and author of The TB Survival Handbook,
to launch
www.tbsurvivalproject.org, an advocacy website
designed to engage MDR-TB and TB patients worldwide.
The website provides information and patient
resources, and lets patients connect with each
other. When it comes to HIV, Thorn recalls that
he “learned more from other HIV patients
than from any book.” But since TB patients
must be isolated, Thorn’s idea is to provide
a virtual meeting room for those affected by
TB or MDR-TB. The website receives 1,000 hits
per month.
- In an effort to raise awareness and improve
early detection of TB, and in recognition of
the crucial role that business communities can
play in public health matters, the
World Economic Forum (WEF) spearheaded the
creation of the Business Alliance to Stop TB
in India, in order to help both employers and
employees understand the early signs of infection,
know where to go for diagnosis, seek timely
treatment, and realize that with proper treatment,
TB and MDR-TB patients need not lose their jobs
or be stigmatized. The WEF’s Global Health
Initiative has developed a “toolkit”
for businesses, with guidelines and case studies,
to help employers understand how to deal with
TB in the workplace. The global template of
this business awareness toolkit was developed
in collaboration with Lilly and the International
Council of Nurses. The Indian version is available
in English and Hindi (the WEF’s first
TB document in Hindi). Mindful of country variations,
the toolkit content will be adapted for China,
and South Africa.
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