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Executive Summary

MERCK's MECTIZAN (IVERMECTIN) THIRD WORLD GIVEAWAY will be managed by an independent review committee that will be established to "evaluate applications for free drug supplies and to advise Merck concerning proposed programs," the company said in an Oct. 21 press release. The committee will discuss areas such as distribution, record keeping and early warning for possible adverse reactions. Merck announced the program at a Capitol Hill press conference Oct. 21. In addition to providing the infrastructure to assure proper distribution and use of the drug, the review committee will be charged with preventing diversion of free ivermectin to agricultural markets that would pay for the drug as a veterinarian antiparasitic. Ivermectin is used in the United States under the brandname Ivomec for controlling parasites in animals. Merck's annual sales for the drug are estimated in the $250-$300 mil. range. Beginning by the end of this year, Merck will "donate supplies of the drug for use by qualified programs worldwide for the treatment of onchocerciasis, a parasitic disease that affects an estimated 18 million people, and threatens some 85 million" in developing countries. A House foreign operations appropriations bill includes $4 mil. in funding to the Agency for International Development (AID) to assist in the distribution of Mectizan. Rep. Dwyer (D-N.J.), one of four Congressional figures at Merck's press conference, commented that "just as vital as making the drug available, is ensuring that an adequate distribution system is put in place." Also attending the press conference were the two N.J. Democratic senators Bradley and Lautenberg and Sen. Kennedy (D-Mass.). The World Health Organization also will assist Merck in distribution of the free drug. WHO Director-General Halfdan Mahler noted that the giveaway program "exemplifies the useful results that can be achieved from collaboration between the pharmaceutical industry and the World Health Organization." Mahler maintained that, after continued Mectizan therapy, onchocerciasis or river blindness would "no longer be a significant problem" by the year 2000. Clinical trials showed that a single dose of ivermectin "is able to essentially eliminate the microfilaria in the victim's body," Merck Chairman Roy Vagelos told the press conference. The drug was approved the week of Oct. 5 in France based on a 1,200 patient study. The company plans to support the clinical trials with data on use of the product in roughly 150,000 patients by the end of next year. A single dose of the drug is effective for about one year. "In theory, if one were to give a dose to every infected patient, black flies [which transmit the disease by biting humans] would be unable to find a source of the parasite," Vagelos explained. The Merck exec noted that "this would interrupt transmission, because it is only humans that harbor the parasite." Diethylcarbamazine and suramin have previously been used to treat river blindness.

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