One of the most significant initiatives undertaken by Merck to help improve access to medicines in developing countries is the Merck MECTIZAN^® (ivermectin) Donation Program.

Established 25 years ago, the MECTIZAN Donation Program is the longest-running disease-specific drug donation program and public-private partnership of its kind, and is widely regarded as one of the most successful public-private health collaborations in the world.

In 1987, Merck announced that it would donate MECTIZAN, our breakthrough medicine for the treatment of onchocerciasis, to all who needed it, for as long as needed. More commonly known as “river blindness,” onchocerciasis is transmitted through the bite of black flies and can cause intense itching, disfiguring dermatitis, eye lesions and, eventually, blindness. The disease is one of the leading causes of preventable blindness worldwide.

MECTIZAN relieves the agonizing itching that accompanies the disease and halts progression toward blindness—two characteristics of the disease that dramatically affect the quality of life. With only one annual dose, MECTIZAN is well suited for distribution in remote areas by community health workers. It is the only well-tolerated drug known to halt the development of river blindness.

To facilitate the donation and delivery of MECTIZAN, and eliminate river blindness as a public health problem, Merck established a multisectoral partnership involving the World Health Organization (WHO), the World Bank and UNICEF, as well as ministries of health, nongovernmental development organizations and local communities. At the program’s inception in 1988, Merck also established the MECTIZAN Donation Program Secretariat, housed at the Task Force for Global Health. The Secretariat works with the independent MECTIZAN Expert Committee to provide medical, technical and administrative oversight of the donation of MECTIZAN. In 1991, Merck, the Secretariat and the WHO established the Non-Governmental Development Organization (NGDO) Coordination Group for Onchocerciasis Control; NGDOs play a critical role in MECTIZAN distribution through their work with ministries of health, their expertise in program management and their financial support. They have also played an important role in developing communication strategies that are helping to achieve high coverage and compliance with treatment. This balanced governance and organizational structure continues to support and facilitate the donation of MECTIZAN.

In 1998, Merck expanded the Merck MECTIZAN Donation Program to include the prevention of lymphatic filariasis (LF) in African countries where the disease coexists with river blindness. LF is a devastating parasitic infection spread by mosquitoes. It is caused by threadlike parasitic worms that damage the human lymphatic system. The disease is currently estimated to infect more than 120 million people, with more than 40 million incapacitated or disfigured with swelling of the limbs and breasts (lymphoedema) and genitals (hydrocele). Swollen limbs often develop dramatically thickened, hard, rough and fissured skin (elephantiasis).

In lymphatic filariasis, parasitic filarial worms are transmitted by a mosquito and lodge in the lymphatic system. Those affected may develop kidney damage caused by blockage of the lymphatic system.

Merck has made a long-term commitment to donate as much MECTIZAN as necessary to treat river blindness and to prevent lymphatic filariasis. The goal is to eliminate both diseases as public health problems.

In December 2007, Merck announced a donation of $25 million over eight years as part of an initiative with the World Bank to raise approximately $50 million to help eliminate river blindness in Africa. With this funding, many community-directed treatment with ivermectin CDTI (community-directed treatment with ivermectin) programs are able to implement at least one other health intervention in addition to MECTIZAN delivery, while helping countries and their partners to improve healthcare by expanding other health programs to hard-to-reach communities.

"Twenty-five years after the donation of MECTIZAN through the MECTIZAN Donation Program, we are now close to eliminating river blindness from the Western Hemisphere. This remarkable achievement is also considered feasible in parts of Africa where we once hoped only to control the disease. Thanks to this donation and to the commitment of endemic countries, nongovernmental organizations (NGOs), UN agencies, and the donor community, we can now envision a world free of this blinding and disfiguring skin disease."

Dr. Margaret Chan
Director-General, World Health Organization

Adverse Experience Reporting

While side effects following treatment with MECTIZAN are rare, Merck has developed a rigorous program for monitoring and reporting any adverse experiences (AEs) in the field. With the help of local nongovernmental development organizations (NGDOs), all field-based community distributors are trained in AE reporting; all AEs must be reported to Merck, which then reports them to drug safety and regulatory agencies in the United States and internationally.

The MECTIZAN Expert Committee, ministries of health and the WHO also play a key role in making sure best practices are applied for surveillance of AEs at the community level. The AE reporting form itself has been revised several times during the more than 20-year history of the program to incorporate feedback from clinicians and public health administrators in the field.

Since the inception of the Merck MECTIZAN^® Donation Program (MDP) in 1987, Merck has donated more than 4 billion tablets of MECTIZAN (ivermectin) for river blindness, with nearly 1 billion treatments approved since 1987.

In 2011, 140 million treatments were approved for river blindness and 130 million treatments were approved for LF (with 37 million of those being for both river blindness and LF). To date, Merck has invested approximately $50 million in direct financial support for the MECTIZAN Donation Program, in addition to donating 1 billion treatments of MECTIZAN.

The donation of MECTIZAN also has led to the development of CDTI (community-directed treatment with ivermectin) programs, through which trained community volunteers distribute medicines, a critical element to effective mass treatment programs in remote areas that often lack trained healthcare workers. CDTI programs currently exist in more than 146,000 communities in 28 countries in Africa; CDTI programs for lymphatic filariasis exist in 16 countries in Africa and in Yemen. The CDTI strategy has enabled other health and social services—such as vitamin A distribution, cataract identification, immunization campaigns, training programs for community health workers, and census-taking—to be introduced in often remote communities. Close to 60 percent of MECTIZAN community distributors have assumed the added responsibility of at least one additional health intervention.

Impact

• In 2002, the OPEC Fund estimated that the Merck MECTIZAN Donation Program prevented 40,000 cases of river blindness annually, and that a direct result of this would be a gain of 7.5 million years of productive adult labor
• In the 19 countries of the African Program for Onchocerciasis Control (APOC), more than 3 million disability-adjusted life years have been saved since 1995, and the prevalence of itching and skin lesions due to onchocerciasis has been reduced by 80 percent
• The impact of the MECTIZAN Donation Program extends beyond the immediate health benefits; estimates show that investments in river blindness control programs (e.g., MECTIZAN treatment and aerial spraying to control black fly populations) are helping people live not only healthier but also more productive lives
• In 2011 Colombia applied to the World Health Organization for the certification that river blindness was eliminated, becoming the first country to achieve that milestone. By 2016 it is expected that all six formerly affected countries in the Western Hemisphere (Brazil, Colombia, Ecuador, Guatemala, Mexico, Venezuela) will have achieved certification that river blindness has been eliminated.
• In 2009, Togo became the first sub-Saharan Africa country to stop treatment for LF; continuing surveillance confirms that transmission of the disease was successfully interrupted
• In 2009, the World Health Organization released a study showing evidence that elimination of onchocerciasis is feasible in Africa using currently available tools