A world of difference
Indians call it by the Hindi name of kala-azar, or “black fever.” Virtually unknown in the West, leishmaniasis is a deadly parasitic illness transmitted by sand flies that attacks internal organs, sickening millions and claiming 200,000 lives every year in India, Nepal, Bangladesh and parts of Africa.
Yet the only treatment available is so toxic that it kills 10% of patients. It’s also prohibitively expensive, costing about $100, which is roughly equivalent to the yearly wages of most victims.
An experimental antibiotic may turn this bleak picture around. Called paromomycin, the injectable drug could vanquish the parasite in a few weeks for less than $10 per person.
Untreated leshmaniasis “is a death sentence,” says Dr. Regina Rabinovich, infectious disease director of the Bill and Melinda Gates Foundation in Seattle. “But cost is a huge barrier, so the illness becomes one of those quiet disasters in a family and in a village. This drug promises to be an effective and cheap therapy.”
The disease might still be overlooked by researchers if not for the efforts of pharmacologist Victoria Hale, founder and chief executive of the San Francisco-based Institute for OneWorld Health, a nonprofit drug company started in 2000 to devise treatments for neglected diseases in developing countries.
Paromomycin had been tested in small human tests in the late 1990s, but although it demonstrated up to a 97% cure rate, research was halted. The World Health Organization, which owned the rights to the drug, was facing budget constraints, and the drug began collecting dust in the lab.
Enter Hale. Armed with a $4.7-million grant from the Bill and Melinda Gates Foundation, she joined forces with WHO to complete the last round of tests needed for approval from the Indian government.
In May 2003, WHO and OneWorld began a clinical trial of 667 patients in India, and will release the final test results early next month. If all goes well, says Hale, whose company will help distribute the drug, paromomycin could be available in 2005.
The antibiotic is the first of a series of drugs to treat tropical diseases that are being developed by the Institute for OneWorld Health, which is perhaps the world’s only nonprofit drug company. Next up is a compound that OneWorld licensed for free from Celera Genomics to treat Chagas disease, a bug-borne parasite that attacks the heart and kills 50,000 people a year in Latin America. Also in the pipeline are drugs for malaria and pediatric diarrhea, which kills 2 million babies in developing nations each year.
Hale, along with her husband, Dr. Ahvie Herskowitz, a cardiologist who had experience conducting clinical trials, launched OneWorld to resurrect experimental therapies for tropical diseases that big pharmaceuticals companies had abandoned as unprofitable.
As a drug evaluator for the Food and Drug Administration during the early 1990s, Hale had frequently seen promising medicines stall in development because their U.S. markets were too small.
“This happened time and again, and it was very upsetting,” she recalls. “Many diseases that afflict only a handful of people in the United States are enormous in other parts of the world, and impact the economies and political stability of entire regions.”
OneWorld bridges that gap by persuading companies to donate the rights to promising therapies languishing in their laboratories in exchange for generous tax write-offs -- and valuable public relations benefits. Tapping into drug industry castoffs enables the company, which relies on grants to cover operating expenses, to sidestep the huge expense of developing medications from scratch.
“These partnerships are a key element of our business strategy,” says Hale, who has morphed from a bench scientist into a chief executive. “Every company discovers many more drug candidates than they can possibly pursue. We’re just capitalizing on that” -- and potentially helping millions in the process.
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Nonprofits target TB, dengue fever
A few other nonprofit enterprises have emerged in recent years to fight diseases in developing countries.
Among them is the Novartis Institute for Tropical Diseases, which is funded by the Swiss pharmaceutical company Novartis and is headquartered in Singapore. It aims to find cures for tuberculosis, which kills 2 million people worldwide each year, and dengue fever.
Similarly, the New York-based Global Alliance for TB Drug Development works with the drug industry to accelerate the development of new and affordable tuberculosis treatments.
