03/18/2010 05:12 am ET Updated May 25, 2011

Enteric Disease impact on Global Health, Human Rights, and Environmental Degradation

"The moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in the shadows of life, the sick, the needy and the handicapped," Herbert Humphrey once said. A quarter century later, a pharmaceutical executive riffed on the former vice president, saying that his own "industry should be held to the same moral standard. After all, we're trading in human health and suffering."

I was inspired by these words, but found that the rhetoric didn't match the reality. Indeed, there were some examples of charity by pharmaceutical companies, but there were still vast populations -- and not just those that were financially challenged -- without access to life--saving drugs. So, in 2001, I founded Napo Pharmaceuticals, Inc. in an effort to extend sustainable business practices to the drug industry.

We vowed to provide novel drugs to every country, every population, and every channel of distribution, regardless of social or economic status, and to not make access dependent on an act of appropriation or grant. We established local partnerships to ensure sustainability, both in the highly profitable Western market and the higher volume business of emerging and developing countries. We formed alliances with international relief organizations to aid in disasters. And, we adhere to, and try to advance, environmentally sound policies and fair-trade labor practices.

The drug discovery process at Napo is based on the knowledge of shamans -- traditional healers in the rain forest -- to identify plants, and ultimately compounds, that are more likely to be safe and effective in humans because they have been used in medicinal settings for thousands of years. The first drug to make its way through our business model is crofelemer, a first-in-class gastrointestinal product to benefit populations with chronic disease such as irritable bowel syndrome and chronic diarrhea in AIDS and cancer patients. Crofelemer can also treat cases of acute diarrhea, including cholera, which kills up to three million children under the age of five in developing countries each year and causes measurable morbidity in tens, if not hundreds, of millions more.

One of the collateral benefits of working in the global health arena is being reminded that disease doesn't exist in isolation. Diarrhea is not just diarrhea; there are repercussions on other areas of health, human rights, and the environment. Recently, Napo gathered a group of international experts at our headquarters in South San Francisco, Calif., to shed some light on these issues. Environmental activist Robert F. Kennedy, Jr., Harvard human rights fellow Ben Skinner, journalist and author James Workman, and International Centre for Diarrhoeal Disease clinical scientist Pradip Bardhan each gave their "scoop on poop."

Kennedy, who has helped indigenous tribes in Latin America and Canada negotiate treaties to protect their natural homelands, stressed the need for sustainable commercial development "not so much for the sake of the fishes and the birds as much as for ourselves." He went on, "Because nature is the infrastructure of our communities and we want to meet our obligation as a nation, as a civilization, as a generation, to create communities for our children and provide them with the same opportunities for dignity, prosperity, and good health as we inherited." He cited as a model Napo's development of crofelemer.

Skinner, from Harvard Kennedy School's Carr Center for Human Rights Policy, touched on the connection between the war on diarrhea and modern-day slavery, which he details in his book, A Crime So Monstrous. Skinner, a descendant in a long line of abolitionists, conveyed his dismay at discovering that as many as an estimated 27 million people are currently enslaved. "[Slavery] is an act so unnatural, a crime so monstrous, a sin so God-defying, that it throws into the shade all other distinctions known among mankind," he said. Faced with minimal access to healthcare in times of crises, many of these slaves are held in what the United Nations calls "collateralized, hereditary, debt bondage," forced to work under threat of violence for no compensation beyond subsistence.

In southern Africa, people are literally waging wars over water, said Workman, whose book, Heart of Dryness, depicts -- through the lens of the Bushmen living there -- the struggles arising from a lack of clean water. Under normal circumstances, he explained, we primates are social animals, but water scarcity can turn us against one other. This survival instinct, he said, leads to the unconscionable use of water as a weapon or tool to coerce behavior. He offered up an example of the Botswana government limiting an ethnic group's access to water in an effort to force it from a particular region of the Kalahari Desert. The Bushmen had to decide who in their band received the drinking water, and who was to go thirsty. "No one should be forced into a position to turn against a family member or fellow being," Workman said. "We can find ways to let people secure water within our communities to make sure that we don't need to turn against each other, because we are more than primates; we are humans."

Bardhan, a physician in Bangaldesh who is regularly dispatched to cholera crises around the world -- including the recent outbreak in Zimbabwe -- pointed out that although diarrhea-related mortality rates have decreased over the years thanks to medical advances such as oral rehydration solutions and zinc, the number of cases per child has remained constant. Thus there is still a need for a treatment that will safely modify the disease process, decrease its duration, and reduce the rate of water and electrolyte loss to prevent dehydration. "That's why I became interested in crofelemer," Bardhan said. "I'm very happy to see the results so far in clinical trials. The drug could be especially applicable in crisis situations like cholera epidemics to prevent massive mortality."

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