Doing exactly that in impressive fashion is the Bill & Melinda Gates Foundation, which helped fund the country's "first nonprofit pharmaceutical firm"—the Institute for OneWorld Health, based in San Francisco. In 2000 former biotechnology executive and U.S. Food and Drug Administration official Victoria Hale, Ph.D., founded OneWorld Health to "address the wide gulf between human need, scientific effort, and the marketplace."

Her goal falls directly in line with the Gates Foundation's mission to bring innovations in health and learning to the global community. (Besides global health, the Gates Foundation has three other focuses: education, libraries, and the Pacific Northwest.)

The Gates Foundation "strives to increase global health equity in developing countries by supporting alliances and organizations working in infectious disease prevention, vaccine research and development, and reproductive and child health." Past vaccine research and development grant initiatives have focused on AIDS/HIV, pediatric enteric disease, malaria, tuberculosis, dengue fever, and a new type of measles.

Ms. Hale approached the Gates Foundation for funding in 2001. Her "risky new venture," according to the foundation, was predicated on unused intellectual property and creating innovative opportunities. Her premise was to resurrect expired drug patents and recycle abandoned research and development on drugs to treat tropical parasitic diseases such as malaria, diarrhea, Chagas and visceral leishmaniasis (Kala Azar or Black Fever)—deadly infectious diseases that disproportionately affect people in developing countries.

OneWorld Health's initial focus was on Black Fever, a disease transmitted by female sand flies that afflicts as many as 1.5 million people and kills approximately 200,000 every year. Most deaths occur in Bangladesh, Brazil, Nepal, and Sudan, with more than half of the cases in Bihar, India.

Resurrecting potential cures

In the 1960s an Italian pharmaceutical firm developed a drug to treat infections. In the 1980s a Kenyan physician, supported by the World Health Organization (WHO), tested that same drug, Paromomycin, as a potential cure for Black Fever. The study was successful in curing all of the patients who received it. Although his study and other studies in India proved effective, WHO was unable to secure follow-up funding. Today, with the cooperation of WHO and the International Dispensary Association in Amsterdam, OneWorld Health took the drug through the final stages of development; clinical trials have been successful.

In May 2002 the Bill & Melinda Gates Foundation approved the first of five grants ($4.6 million) to fund Ms. Hale's goals to provide bridges "between novel bench science and its conversion to applications for the developing world" and "academia and industry resources such as chemical libraries or specific assay reagents."

To date, OneWorld Health has received grants totaling $144.8 million from the Gates Foundation.

Challenges

But navigating bureaucracies and garnering support from governments and international organizations can be challenging. One of the first hurdles for OneWorld Health was obtaining nonprofit status. The Internal Revenue Service turned down OneWorld Health's request several times before granting approval. Government authorities abroad were also slow to welcome them as were some international health organizations.

OneWorld Health forged ahead by forming partnerships nation- and worldwide that garnered respect and recognition. Those currently involved include: Jay Keasling, professor of chemical engineering and bioengineering at the University of California, Berkeley; Yale University; Celera Genomics; Walter Reed Army Institute of Research; Indian Council of Medical Research; and others spanning the globe from Boston to Geneva to Bangkok. According to Ms. Hale, "The Gates Foundation funds are the catalyst for us to partner with some remarkable researchers, government officials, and manufacturers in India, and other nations in the future, to create a local solution that meets the highest international quality standards."

In spite of skilled collaborators and substantial financial support from the Gates Foundation, challenges remain.

Funding concerns plague all nonprofits—especially new, innovative organizations with one primary champion. To date, the Gates Foundation has been the largest donor to OneWorld Health, providing 96 percent of its funding. Other foundation contributors include Artemis, Chiron, Lehman Brothers, Pfizer, Vital Spark, Gap, Amgen, and Skoll (founded by Jeff Skoll, the first president of eBay). And the John D. and Catherine T. MacArthur Foundation awarded Ms. Hale an unrestricted, five-year $500,000 fellowship in September.

As a foundation that has provided a total of more than $10.8 billion in grants since 1994, the Gates Foundation has a refined set of criteria by which grantees are assessed. In a "What We're Learning" case study report by the Gates Foundation, OneWorld Health successes as well as challenges are cited. Although OneWorld Health has proven that a nonprofit pharmaceutical firm can develop new medicines for diseases of poverty, it cannot indefinitely depend on one source for the majority of its funding.

To ensure that OneWorld Health succeeds over the long term and that other nonprofit organizations join the field, the Gates Foundation is
seeking ways to help them expand their funding base. One way the Gates
Foundation brings attention to organizations like OneWorld Health is by highlighting them as case studies on their website. Here they are "open and frank about what we're learning from our grantmaking—what is working, and what isn't." Keeping public and private funders aware of their findings is helpful not only for current project accountability, but also for future grantmaking.

After the long process of research and development, clinical trials, and regulatory approval, the actual distribution of drugs to patients in developing countries can prove equally exhausting. Political, economic, and social quagmires have too often halted laudable efforts. An unfortunate example is the United Nations' oil-for-food program. Failure to distribute life-saving drugs, though, according to the World Health Organization, "is not the fault of patent restrictions, but the lack of funds to buy these products and inadequate infrastructure to deliver them." 

Establishing effective country, community, and village-level referral networks will be critical to any developing country outreach.

In June 2006, OneWorld Health and India-based partner Gland Pharma, Ltd., submitted a 7,000-page dossier to the Drug Controller General of India (DCGI) for regulatory approval for Paromomycin IM Injection. In September OneWorld Health received approval from DCGI and will move forward with Gland Pharma to develop a safe and efficient process to produce the life-long protection drug for a price of about $10 per complete treatment.

Today there may be more questions than answers concerning how to treat and how to reach the diseased poor of the world, but with hope in the ingenuity and enthusiasm of motivated risk-takers and generous philanthropists and foundations, the answers will be revealed.

For additional information about the organizations mentioned, visit:

Institute for OneWorld Health: www.oneworldhealth.org

Bill & Melinda Gates Foundation: www.gatesfoundation.org

Bill & Melinda Gates Foundation 2005 Annual Report: www.gatesfoundation.org/nr/public/media/annualreports/annualreport05

Angela Richabaugh Shears is a writer and editor in Newville, Pennsylvania.