If pharmaceutical companies routinely overcharge for their products, as many critics allege, few would dispute that those products can be pricey to develop. This may or may not justify the price you pay for prescriptions; that depends on how you interpret the expense-versus-profit figures in the accounting books.

The president of the Pharmaceutical Research Manufacturers Association (PhRMA), Alan Holmer, estimates that on average it costs $500 million to develop a drug, and that it takes 12 to 15 years to get it from the lab bench to the pharmacy. PhRMA publications indicate that for every single drug eventually approved by the Food and Drug Administration (FDA), between 5,000 and 10,000 compounds must be synthesized and tested. The industry, Holmer estimates, invested $24 billion in research and development in 1999, up from an estimated $15.6 billion in 1996.

Despite these development costs and disagreements surrounding pharmaceutical pricing policies, it is possible today to spot what everyone can only hope will become a common corporate practice: large drug companies are accepting the challenge of treating devastating diseases among populations that can't afford to pay a cent.

Last year, for instance, Smithkline Beecham announced it would donate albendazole, a treatment for countering the parasitic worms that cause lymphatic filariasis, as part of an effort to conquer the disease in over 70 nations. Also known as elephantiasis, lymphatic filariasis is characterized by disabling and grotesque enlargement of the limbs and genital organs.

"We've never done anything on this scale before. This is a tremendous opportunity for us to treat one of the most disabling, disfiguring diseases in the world," said James Hill, Smithkline's senior vice president for corporate affairs, when the program was announced.

Last year, Pfizer announced a treatment program for trachoma, and three years ago Glaxo Wellcome announced a program for treating malaria. Working on this scale of charity is a relatively new chapter in the corporate histories of many drug companies, but it is not new for Merck & Company. The company established itself as a leader in the field of taking on a third-world disease and bearing the long-term cost for treating patients who do not have, and never will have, the money for treatment.

The goal of the pioneering Merck program is the control of onchocerciasis, aka river blindness, a disease caused by a parasitic worm, Onchocerca volvulus. Nonfatal but chronic, the infection is spread by blood-sucking female blackflies. Infection follows the bite of a fly carrying worm larvae. The worms grow and live under the skin for as long as a dozen years. But it is the offspring, microfilariae, that do the damage. Their migration through the skin can produce severe itching, rashes, skin atrophy, and blindness. The disease continues after the infected person is bitten by another fly, which starts the process again. Eighteen million people in Latin America and Africa may be infected.

Twelve years ago, Merck pledged to provide, at no cost, ivermectin or Mectizan, a treatment for onchocerciasis, for as long as it takes to remove the disease from the list of serious public health threats in the third world.

"We are most proud that the program is being used as a model of similar health care initiatives," Brenda Colatrella, manager of product donation at Merck in Whitehouse Station, New Jersey, tells HMS Beagle. "Before the decision was made, there was some concern on the part of many that if Merck were to announce that they were going to donate this drug free of charge, that it may impede tropical disease research because other companies would feel that they then would have to donate any discoveries they made. The interesting thing is - and we couldn't be happier about it - many other companies have looked to the Mectizan Donation Program as a model."

In 1988-1989, more than 60,000 people received their first dose of donated Mectizan. By 1992, the number had increased to 4 million. "In 1997, we estimate that approximately 19 to 20 million people were treated. In 1998, the estimate is 25 million people," Colatrella says.

The increase in recent years can be attributed to help from organizations such as the World Bank, which in 1995 committed itself to raising between $120 and $130 million dollars over 12 years to help fund the African Program for Oncoceriasis Control, which includes Mectizan distribution.

"If we can eventually, by the year 2007, reach 50 million people, then there is a good chance the disease can be controlled as a public health problem," Colatrella says. "It may be possible to control river blindness upon reaching this goal, because epidemiologists know it is not necessary to treat every susceptible person to disrupt the life cycle of a disease-producing organism. Treating enough individuals to interfere with the life cycle of the parasite may be enough."

It is not easy to find out how much all this costs Merck. "No one has ever really sat down to figure out what the program costs. It would be a very difficult number to get at. You would have to look at the clinical trials that were done on human-grade ivermectin over a 10-year period, as well as other factors. Merck doesn't cost out its programs according to specific products," Colatrella says.

Colatrella attributes the success of the Mectizan Donation Program to cooperation among the many organizations involved in it. "When I first came into the program, I sat in on my first meeting where [representatives of] the organizations involved - the WHO, the World Bank, the NGDOs [non-governmental development organizations], local ministries of health in affected countries, Merck, and donors that provide funding to the World Bank . . . those who deliver and distribute the drug - were around the table. And I was absolutely in awe. I know it sounds dramatic, but I cannot tell you how amazed I was that you had a group of individuals sitting around a table who were able to put aside personal agendas - and there is politics as there is with anything - but they were able to put aside personal agendas to really work toward a common goal," Colatrella recalls.

Stephanie Meredith is the director of the Mectizan Donation Program in Decatur, Georgia; it is a program of a small nonprofit organization called the Task Force for Child Survival and Development. Meredith and her colleagues, who are employees of Emory University, oversee the donation of the drug to countries around the world. In Latin America, these include five countries where the disease was undoubtedly introduced, she says, as a result of the African slave trade, and Mexico where it was introduced by mercenary Sudanese soldiers in the nineteenth century.

"It is very focal, very small [in the Western Hemisphere]. Ninety-nine percent of the disease occurs in Africa. There are 28 or 29 countries in Africa that are endemic for onchocerciasis. Merck is providing the drug to all of them. It is difficult to estimate how long might the contributions be needed," says Meredith.

"The best data I have is from the program in Cameroon that has been reported after eight years of treatment using only Mectizan with no use of insecticide," Meredith says. "We can see there is an incredible drop in the prevalence of the disease and in the incidence in young children. On the intensity of the infection, the drop off is enormous: 88 percent reduction of microfilarial intensity in infected people and an even greater drop in children."

The adult female worm lives an average of 12 years. It can live 15, or even 16 years. "You have to cover at least 65 percent of the total population in an endemic area for at least as long as the adult worm lives before you can have any real impact on the disease as a public health problem," Meredith explains.

Mectizan has an advantage over medications for tropical diseases that must be given many times over the course of days, weeks, or years: it is effective when taken once per year. It doesn't cure the disease, or even kill the parasite. Instead, it prevents the release of microfilaria from the female worm. By limiting their numbers, the treatment limits injury to victims and can break the cycle of infection from human to fly to human.

While the practice of giving away drugs to prevent and treat blindness and other disabling diseases may seem above criticism, it is not. One obvious criticism is mentioned in Peter Wehrwein's article, "Pharmacophilanthropy," in the Harvard Health Review. The article quotes Richard Laing, a professor of international health at the Boston University School of Public Health, as noting that the ivermectin program is expensive and difficult to administer. Resources now spent to distribute ivermectin might be used instead to treat yellow fever or meningitis. (It is easy to predict that such a switch in priorities would then be criticized for neglecting onchocerciasis.) Laing is quoted, however, as saying that "the ivermectin program is on balance a positive effort that is meeting a real need."

Another criticism cited by Wehrwein reflects the suspicion that drug company philanthropy is really just a public relations exercise "designed to undermine the case for fair trade in drugs." This point was raised by Philippa Saunders, who works for a nonprofit group that supports NGO pharmaceutical services in developing countries, the Essential Drugs Project in London. Saunders, it should be noted, supports drug company donation programs and believes that Merck's program to eradicate river blindness has "proven itself."

Obviously more could be done. The noteworthy aspect of such programs is that they are being undertaken at all by corporations whose first and top priority is to make money. Corporate motives mean less than the results of their efforts. If more giant pharmaceutical firms decided to initiate such programs, despite any criticisms, more lives would be saved and improved in underdeveloped countries.

Charles Fettig, senior director in Merck's marketing group for antibiotics and Mectizan, affirms Merck's original promise regarding the onchocerciasis program: "Our commitment is open-ended. We will donate as much as necessary, as long as necessary." He thinks there is no doubt that the Merck program has inspired other companies to consider similar programs.

Meredith agrees: "Perhaps the whole socioeconomic impetus for good corporate citizenship has changed in the last 10 years, which I think helped these other drug companies come through with these kind of donations," she says. "Merck's donation of Mectizan and some of their other corporate philanthropy programs definitely helped maintain it high up in the Fortune 500. They won a lot of awards for their humanitarian work. Jimmy Carter called them 'the drug company with a heart.' Over the last few years, I've seen people looking at what a company does apart from its profits."