Victoria Hale was captivated as Shyam Sundar, a doctor from India, lambasted the medical community at a 1999 conference in Belgium.

An expert on black fever, Sundar warned that the epidemic could spread like HIV in his country.

His message: Something could be done, but nobody cared.

Hale did care. She asked to visit Sundar's clinic in Muzaffarpur, India, in 2000. The experience moved her to tears. She had never seen such misery. So many were withering from black fever.

The disease, also known as visceral leishmaniasis, spreads from person to person or animal to person by bites from sand flies.

It causes fever, severe weight loss and anemia. The spleen and liver swell, blowing the stomach out like a balloon. The immune system weakens, increasing a patient's risk of other infections.

If left untreated, black fever kills 100% of its victims. Every year it plagues half a million people, 90% of whom live in poor villages in India, Bangladesh, Sudan, Brazil and Nepal. The United Nations' World Health Organization says the disease kills 57,000 annually.

Known treatments cost as much as $200 — too much for the poor in developing countries. They can also be ineffective or toxic.

A Drug In The Dark

Doctors Without Borders found that a cheap antibiotic, paromomycin, showed some promise fighting black fever. It was meant to treat only intestinal parasites when it was first approved in 1959. In the mid-1990s, the WHO did small trials to test paromomycin for black fever. But the research stalled when the organization couldn't find a sponsor for deeper testing.

The antibiotic's only manufacturer, Pharmacia, which was acquired by Pfizer (PFE) in 2003, took it off the market. The patent for paromomycin had expired. Other firms brought new drugs to treat intestinal bugs to market. Using paromomycin to treat black fever had little commercial potential, so it sat dormant.

Hale had seen enough. She took action to make paromomycin available to treat black fever.

"I feel if we're born in a part of the world where we have what we need, a good life and education, why not for just a part of your life, maybe five to 10 years, take a sabbatical and figure out what each of us can do as individuals to leave the world a better place," she told IBD.

"I was always inspired by Mahatma Gandhi, Martin Luther King and civil rights in particular. To me, civil rights include access to basic health care and access to enough calories and food to eat."

In 2000, she founded the San Francisco-based Institute for OneWorld Health — the world's first nonprofit drug firm — which would develop drugs for neglected diseases afflicting the Third World.

Hale, 46, developed her love for science while growing up near Washington, D.C.

She took that fascination to the University of Maryland, where she majored in pharmacy, and the University of California, San Francisco, where she earned a Ph.D. in pharmaceutical chemistry.

From there she helped develop drugs as a scientist at Genentech (DNA) and became a senior reviewer at the Food and Drug Administration.

She was following her creed: "I believe that medicines are really miracles and that we should develop all the medicines that we can."

Given her experience, she saw that most miracles happen in the Western world — not developing countries, which host 90% of the world's diseases. "I really realized clearly that there were some diseases for which we had potential new drugs that were not going to be pursued because the market wasn't big enough or the market was overseas or the market was in the developing world," she said.

Of the 1,556 drugs that were brought to market in the past three decades, only 21 treated diseases in the developing world. Big drug makers have little incentive to serve that market, as it takes about $1.2 billion and an average of eight years to develop a drug, according to a 2006 report by the Tufts Center for the Study of Drug Development.

Hale's husband, Ahvie Herskowitz, a professor at the University of California, San Francisco, doubled as chief medical officer of OneWorld Health while they worked out of their house.

Aside from the idea of starting a company or curing a disease, Hale aimed to prove a principle.

"I had a burning passion to help the pharmaceutical industry figure out how to get past this obstacle: diseases that affect very poor people," she said. "It's so fulfilling. It's totally about benefiting and serving humanity."

Despite her good intentions, Hale had to deal with naysayers.

The Bill and Melinda Gates Foundation — a major funder of health programs — rejected her first request for funding in 2001. The foundation said it was concentrating on vaccine development. It offered to fund her if she would develop vaccines, and asked her to become a nonprofit vaccine company.

Hale turned down the offer because she didn't know how to develop vaccines. She wanted to successfully test an old drug for a new purpose rather than risk failure with a new drug.

"I was very clear with myself as to how I would be able to succeed as a leader, and equally clear on what I did not know how to do," she said.

The foundation changed its mind in 2002 and gave her a $47.2 million grant to develop paromomycin. But the clinical trials cost more money and took much longer than anticipated.

The WHO was reluctant to share data from previous research trials. When Team Gates asked the WHO to expedite the release of the data, the U.N. outfit accused the foundation of bullying. Hale had to negotiate for two years so the WHO could come through.

"One of our early mistakes was our idealistic and naive belief that we could (or) would partner with anyone in the world necessary to complete our programs to benefit humanity," Hale said.

Since OneWorld Health and the Gates Foundation were fledgling groups, Indian and international health organizations hesitated to work with them on the clinical trials.

Indian politicians didn't like foreigners drawing attention to their communities' problems. And in the first year, one of Hale's partnerships went south.

"This was a painful experience for individuals, slowed the program and put it in jeopardy for a period of time," she said.

Despite those obstacles, Hale completed the clinical trials of paromomycin in November 2004. Her team tested 667 patients at clinics in India, including Shyam Sundar's.

"We share a similarity in that she, like me, worked even at the expense of the family, personal savings, personal property, at no gain," Sundar said.

Paromomycin cured 95% of the patients without causing major side effects. In August 2006, India's health ministry approved the drug.

The Institute for OneWorld Health partnered with an Indian drug maker, Gland Pharma Ltd., to make paromomycin and sell it at cost — about $10 per dose.

The institute has dispersed 10,000 doses.

"It was more important to have a success story with a small program than to have a large program that people would recognize but then risk failure," Hale said.

Foundation's Lift

Paromomycin's approval was a milestone for the Bill and Melinda Gates Foundation. It's the first drug the $33.4 billion foundation helped lift through the regulatory process.

"IOWH's work on paromomycin has proved to us and to others that a nonprofit organization can help correct the 'market failure' that results when there are inadequate incentives for private industry to address neglected diseases," the foundation said in a June 2006 report. "Paromomycin would have languished in obscurity if not for (OneWorld's) efforts."

Hale suggests that people who are dissatisfied or bored with their careers take time off.

"And then talk to people and get to know someone or a community or a part of the world that has nothing to do with you, that will surprise you, that will inspire you, that will enlighten you and give you some ideas about what you can do," she said. "Fall in love with a part of the planet that's somewhere out of your comfort zone."


BY TRANG HO