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 nearly 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, over time, 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 and duration 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. In 1988, Merck established the MECTIZAN Donation Program Secretariat, housed at the Task Force for Global Health, 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, expertise in program management and financial support. They have also played an important role in developing communication strategies that are helping to achieve high coverage and compliance with treatment.

In 1998, Merck expanded the Merck MECTIZAN Donation Program to include the prevention of lymphatic filariasis (LF), commonly referred to as elephantiasis, in African countries where the disease coexists with river blindness. An estimated 300 million Africans are at risk, and another 40 million are infected by this disease.

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. The disease is commonly known as elephantiasis because it can lead to the disfiguring enlargement of the arms, legs and genitals. Through Merck's work with the Global Alliance to Eliminate Lymphatic Filariasis, nearly 120 million treatments of MECTIZAN were approved in 2010 for lymphatic filariasis in 18 African countries and Yemen.

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. The World Bank has raised the remaining $25 million, providing all the funding necessary for 28 African countries affected by river blindness to develop self-sustaining MECTIZAN distribution programs by 2015. With this funding many community-directed treatment with Ivermectin (CDTI) programs will also be 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.

"The unique and broad-based partnership that has evolved around onchocerciasis control is extremely important and helpful to the invermectin mass treatment efforts, bringing about results that no single party could achieve. Much of the experience gained in the development of ivermectin treatment can usefully be applied in the recent broader perspective of control of neglected tropical diseases."

B. Thylefors, M. M. Alleman and N.A.Y. Twum-Danso
"Operational Lessons from 20 years of the MECTIZAN Donation Program for the Control of Onchocerciais," Tropical Medicine and International Health 2008:13(5):689-696.

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 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 20+ year history of the program based on feedback from clinicians and public health administrators in the field.