One World Health: Non-Profit Brings Life Saving Drugs to Developing Countries
By Chris Johnston
Sometimes inspiration comes at the most unlikely times in the oddest places. For Victoria Hale, her moment arrived in a New York taxi during a casual conversation with her West African driver on her way to the airport. When she told him she was a pharmaceutical scientist, he responded with a hearty laugh: "You guys make all the money." His laughter pierced her "like a knife in my soul," she recalls.
"I cringed at the thought that I represented an industry that was perceived to have all the money," Hale continues. "I entered the field because I thought I could make a difference by developing drugs, so that incident spurred me to action."
Driven by this spur, Hale decided to launch the Institute for OneWorld Health. Founded in San Francisco in 2000 on nearly $5 million in grants from the Bill and Melinda Gates Foundation, the first nonprofit pharmaceutical firm fights the most deadly parasitic diseases in tropical and developing nations. Hale and her 25 employees went on to raised $11 million, which is significant for nonprofit OneWorld Health, but pales in comparison to the amount that Merck, Pfizer or other major pharmaceutical companies spend daily. In fact, in 2002, the major pharmaceutical players spent approximately $32 billion on R&D.
The beauty of Hale's concept is that it creates a win-win strategy for all involved. Her company obtains existing research that the large pharmaceutical players have shelved for lack of profit potential, for which they receive significant tax benefits as contributions to a nonprofit organization. OneWorld Health then produces as drugs that are desperately needed in developing nations. These countries also benefit from the local businesses created to produce and distribute the drugs.
Knowing that her new nonprofit pharmaceutical venture had to be successful with its first project to be taken seriously, Hale traveled extensively, interviewing numerous scientists for potential drug leads and consulting with scientific advisors for the first year. "I concluded that we would focus on infectious diseases, an area not addressed much by the industry, which meant we would not compete with other pharmaceutical companies," she says.
Hale also directed her company's mission toward seeking markets no one else was pursuing by providing relief for the impoverished individuals of developing countries who are battling diseases the giant drug companies essentially ignore, since there is minimal incentive to pursue profits through sales in undeveloped regions. Instead of letting drugs with the exciting potential to cure many common or obscure maladies in these countries, OneWorld identifies areas where there are little or no adequate or affordable treatments for infectious diseases. They then locate medicines that have lapsed into off-patent status or languished in commercial pharmaceutical laboratories, then develop, test and manufacturer them. The firm then directs the clinical trials necessary to have the drugs approved so they can combat these killers that threaten millions of lives in Africa, Asia and Latin America.
Unlike traditional drug companies who are answerable to their shareholders and must turn a profit, OneWorld Health can focus on developing drugs that are truly needed to address Third World diseases. "As a nonprofit pharmaceutical company, we take the pressure off turning a profit," explains Joanne Hasegawa, communications manager for OneWorld Health. "We make our decisions on which disease area and which drugs to develop based on the need and the prospects for creating a successful drug affordably, safely and effectively."
So, that's how OneWorld became experts in the deadly disease visceral leishmaniasis (VL) that is transmitted via the bite of an infected sand fly. The disease causes fever, weight loss, enlargement of the spleen and liver and anemia. Left untreated, it is nearly always fatal. Approximately 1.5 million people currently suffer from VL, and another 500,000 cases arise annually worldwide. Each year, roughly 200,000 people die from the disease. More than 90 percent of the cases occur in India, Bangladesh, Sudan, Brazil and Nepal.
Currently, OneWorld is completing Phase III of a clinical trial of an injectable form of an antibiotic known as paromomycin to counter VL in India, where 667 patients are enrolled. The fourth and final phase was completed in 2004. At that time, the firm prepared a dossier to submit to the Indian government for drug approval in 2005 as a once-a-day, 21-day cure for VL, which also provides lifetime immunity.
"Fortunately, Bangladesh and Nepal have similar requirements," Hasegawa says. "So once the Indian government approves, it should be a fairly straightforward process for the other countries to also approve the drug."
OneWorld Health, which maintains a staff of pharmaceutical scientists and regulatory affairs experts, discovered paromomycin was an off-patent drug that the World Health Organization had begun conducting drugs trials with in the early ‘90s. However, the trials stopped when funding dried up. The drug was originally developed by Pharmaceia, which was acquired by Pfizer acquired a few years ago. The FDA had approved paromomycin several decades ago, and it is still marketed in the U.S. as an oral formulation to treat intestinal parasites.
Her organization will also pursue approval by either the European Union or the FDA to use paromomycin to treat VL, Hasegawa says, since their imprimatur will facilitate approval in other countries where OneWorld hopes to supply the drug. The firm also researches and devises distribution plans that incorporate the most effective ways to transport the drug to areas where the disease is most pervasive and reach the people who need it most. These plans typically feature establishing collaborations with government agencies and other global health organizations, as well as conduct clinical trials and seek regulatory approval for the drug in other regions. OneWorld also collaborates with suitable manufacturing partners that can produce the drug for an affordable price.
Ironically, this new medication may soon have widespread application in the developed nation that created it, since many American soldiers are being bitten by infected sand flies in the deserts of Iraq. Many are contracting a nonfatal form known as cutaneous leishmaniasis that results in serious disfigurement. In addition, OneWorld Health is working on other drugs to combat a variety of infectious illnesses, including chronic diarrhea; Chagas disease, an insect-borne threat and the leading cause of death from heart disease in Latin America; and malaria.
In the coming years, Hale hopes to keep her company small, with about 75 or 80 employees, so that OneWorld can continue to operate like a small, nimble biotech company, spotting opportunities and making decisions quickly. She would also like to hire seasoned scientists and managers from the industry to lead project teams and mentor staff. "We need to maintain a focus on certain disease areas to ensure that drug development progresses, and keep the pipeline filled to ensure there are new candidates should others fail," she says.
Inspired by the organization's efforts, two other nonprofit vaccine companies have already asked Hale for her help in getting started, Global Solutions for Infectious Disease and another firm still in its formation stage.
Moreover, the energetic CEO and the early successes of her company have earned respect throughout the industry, which was part of her initial plan. Today, she's reaping the rewards of support from volunteers who want to help and from high-profile admirers. "In five years of existence, we've gotten the ears, minds and hearts of people in the industry, academia, government and philanthropy to believe in us and that our business model is working," Hale says. "Increasingly we have the support and momentum to achieve even more results, which translates to saving lives sooner rather than later through drugs we've developed."
In one recent article, a major pharmaceutical executive, Edward Penhoet, former CEO of Chiron Corp., said he is a convert to the nonprofit enterprise because it's not in the economic interests of the largest drug and biotech companies to do the work of OneWorld Health. "The institute should fill a huge gap in bringing badly needed drugs to market for the majority of diseases that afflict the undeveloped world," he said.
For her part, founder Hale believes the international drug companies will prove willing to support her venture by turning over promising research results for the critical drugs necessary to drive the firm forward. In the same article, she concluded that, "They have the best drug candidates on their shelves."
Of course, Hale says in addition to continued success, she would like to employ her "thoughts and visions" to inspire other organizations to make the world a more equitable place through business principles with social missions that address global health issues. "We can't do it all ourselves," she concludes. "The world needs more swift-footed social entrepreneurs to get things done."
*Stories published in this section are discovered via the World Inquiry into Business as an Agent of World Benefit. For more stories like the one you have just read visit the World Inquiry Innovation Bank.
