“Everybody gets into chemistry because you want to help the world somehow,” says Dr. Joseph Fortunak. Motivated by this, Dr. Fortunak graduated from the University of Wisconsin-Madison with a PhD in Organic Chemistry and after a postdoctoral stint at Cambridge University spent over 20 years in the pharmaceutical industry, most recently as Director and Head of Global Process R&D at Abbott Laboratories. Dr. Fortunak brought new drugs through development for illnesses including heart disease, cancer, HIV, and malaria. Early on, Dr. Fortunak was introduced to green chemistry. He describes that as an organic chemist working in drug discovery, process efficiencies were always a concern. However, when Paul Anastas and John Warner’s slim volume, “Green Chemistry – Theory and Practice” was published in 1998, it “consolidated the subject” by bringing a focus and a framework to the collection of technologies and approaches that could, among other things, bring down the cost of drug production.
Throughout his work, Dr. Fortunak had occasion to travel to many parts of the world—including India, China, and Africa—where he saw firsthand that no matter how many new life-saving drugs were brought to market, much of the world continued to have little access to medications. The richest 15% of countries consume 91% of all medicines (ATM; 2010) and according the World Health Organization (WHO) an estimated 2 billion people do not have adequate access to medicine. “If we are going to make the fruits of technology available to the rest of the world it’s got to be done much more efficiently then it’s done now,” Fortunak realized. It was clear to him then addressing this global challenge would mean working outside industry—since new drug discovery, although very important, wouldn’t solve the problem of access. Always wanting to someday return to academia, he joined Howard University in Washington, DC as a Professor of Chemistry and Pharmaceutical Sciences in 2004.
Here Dr. Fortunak and his students use green principles to develop new chemistry for key drugs, including those used commonly for HIV/AIDS and Malaria, in order to lower the price and make them more available in lower income countries. Working with non-governmental organizations, such as the Clinton Health Access Initiative, Dr. Fortunak has distributed this new science to generic drug manufactures in India and China without charge or royalties.
In 2007, Dr. Fortunak got a call from an old friend, Dr. Steve Byrn at Purdue University who had met an African health specialist and nun named Sister Zita Ekeocha. Sister Zita, had previously managed the faith-based medical stores in Nigeria, a network responsible for distributing roughly 60% of all medications in that country of 160 million people. Sister Zita was on a mission to teach Africans how to manufacture their own generic medicines.
In Africa there is a real problem of both access to medicines and quality of the medicines available—a 2007 study by US Pharmacopeia revealed that 48% of drugs imported to Africa were either counterfeit or substandard. While the World Health Organization and USFDA have quality standards that successfully regulate medicines which flow through donor agencies, these comprise only a portion of the medicines available and only cover a handful of high profile diseases like Malaria, HIV, and Tuberculosis. Getting medicines for other diseases, even if one had the money—and many Africans do not—is very difficult if not impossible for most people. The pharmaceutical industry within much of Africa is nascent, lacking the expertise and resources to thrive, as are the African drug regulatory bodies. Highly trained Africans often leave the country to study and don’t come back. Tanzania for example has only 1 pharmacist for every 70,000 people and even fewer doctors. None of the significant global funds available to purchase drugs through donation monies are available to African manufacturers because – with very few exceptions – they do not meet international standards for Good Manufacturing Practice (GMP). Cultivating pharmaceutical sciences and drug regulation in Africa could, therefore, be an effective means of improving access, quality, price, and encouraging economic development.
In 2008, Dr. Fortunak, Dr. Byrn and Sister Zita first met in Abuja, Nigeria and formed a collaboration. Sister Zita was already advancing plans for the Industrial Pharmacy Advanced Training (IPAT) Program at the Kilimanjaro School of Pharmacy in Moshi, Tanzania through the Saint Luke Foundation. The new program would be designed to accomplish two objectives: “One of these is to teach Africans to manufacture their own high quality drugs at affordable prices to expand the supply of medicines and make them more available. And the second is to teach the fundamentals of drug discovery and drug development so that, well-trained pharmacists can build an independent, sustainable future.”
With funding from the United Nations Industrial Development Organization (UNIDO) they developed a Graduate Certificate Program for industrial pharmacy and quality control comprised of a sequence of four courses over two years. (A proposal is in place to expand into a Master’s Degree in 2013.) The classes explicitly teach green chemistry. For example, Dr. Fortunak set up a challenge for one of his graduate students at Howard to develop new chemistry for two drugs that go into an Artemisinin Combination Therapy (ACT) for Malaria—Dihydroartemisinin and Piperaquine—using only solvents and processes easily available in Africa. Dr. Fortunak’s student, Christopher King, managed to reduce the E-Factor, or ratio of the mass of waste per unit of product, of Piperaquine from 45 to 6. Then on an ACS GREET Scholarship, Chris took this research to the classroom and laboratory in Tanzania where the students used it to manufacture both active ingredients and then formulate these drug into adult- and pediatric-strength tablets. Dr. Fortunak estimates the cost of producing the drug this way is 50% cheaper, and of course, can actually be made in Africa.
Since the program started, 50 professional students have graduated. Seven of these are university professors in Africa, and the remaining are about equally split between industry and government. Of the industrial students, four companies have applied for and three already received qualification for either the USFDA or the WHO standards, giving them access to the global drug market for the first time, and building a foundation for sustainable drug access in Africa. Additionally, the IPAT team recently held a workshop with the US FDA for government regulators in Africa covering training to both assure medicinal quality and catch those who are selling substandard medicines.
His work is an example of how green chemistry can help address a humanitarian issue of great importance, and how the expertise of chemists is needed to help solve global challenges.
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