The Imaginations of Unreasonable Men (15 page)

The nonprofit pharmaceutical was the idea of Victoria Hale, forty-nine, who, with a Ph.D. in pharmaceutical chemistry, worked at the Food and Drug Administration’s Center for Drug Evaluation and Research for four years at the
beginning of her career. Shortly before Steve Hoffman left the navy to get business experience at Celera, Hale left the government to do the same at a biotechnology firm called Genentech. She used that experience to start Institute for OneWorld Health in 2000. Like both Hoffman and Keasling, she knew that the effective medical solutions were out there, but that they weren’t being manufactured and distributed at the necessary scale.

In launching the Institute for OneWorld Health, Hale faced the kind of challenges inherent in reimagining something as established as the pharmaceutical industry. She recalled for the
Chronicle of Philanthropy
that it took ten months for the IRS to grant OneWorld’s nonprofit status: “There was no precedent for them to comprehend the concept of a nonprofit pharmaceutical company until we offered the analogy of public versus commercial television . . . which serve different audiences, provide different products, and are funded differently.”
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In October 2007, Hale and Keasling spoke at the annual PopTech conference in Camden, Maine, on a panel called “Changing the Paradigm.” Notwithstanding the overused cliché, it was a significant and telling title. The focus was not on malaria or science but on new ways of thinking to solve seemingly unsolvable problems.

The audience did not have global health, tropical disease, or malaria eradication on their agenda. People who attend PopTech come from a wide variety of fields and are bound together only by an interest in the trends shaping the
future. The chemistry and biology that dominated Keasling’s and Hale’s working hours were complex for the layman and almost impossible to present or summarize. But not so the expansive thinking, leaps of imagination, and collaborative partnerships they had brought to their work. Those had applicability to a wide range of issues and were relevant to the large and diverse audience.

Hale and Keasling had just flown directly from the Malaria Forum in Seattle hosted by the Bill and Melinda Gates Foundation. I watched them on a live video streaming that PopTech offers. Victoria Hale began, as I’d seen her do many times before, with a few images on slides—a typical Indian village with a high incidence of visceral leishmaniasis, a parasitic disease also known as black fever that kills hundreds of thousands a year. Hale paused on a slide of women and children, some of whom had red hair due to nutritional deficiencies. She described them as “invisible people in our world, voiceless, and many are women, which means really voiceless.”

The black fever parasite is spread by the bite of a sand fly. The parasite goes into the bone marrow and suppresses white cells. The cure costs $300 but the average income in Bihar in eastern India is 30 cents a day. The Institute for OneWorld Health also works on malaria and diarrhea, currently in India, Bangladesh, and Nepal, but soon in Sudan and Brazil as well.

Hale went onto describe her own “personal journey, which began at the FDA.” She said, “I was at the FDA for
five years. It was a fabulous job. And then I was at Genentech and had a fabulous time, until one day I wasn’t having fun anymore and resigned.”

“I wanted quiet and to settle the confusion in my mind,” Hale recalled. “Genentech was developing great medicines but for fewer and fewer people. Biotech products are very expensive. I felt this combination of pride in the talents of all those I worked with and shame that as an industry we weren’t doing all we could. If you know that more could be done, how can you not do it?”

The problem, as she saw it, was that “only the pharmaceutical industry knows how to make new medicines. The industry had to be engaged.” “So I designed an experiment to see if a pharmaceutical company could be driven not by profit but by venture philanthropy,” explained Hale, referring to a type of philanthropy in which donors act like venture capitalists, investing in an enterprise’s team and capacity, and establishing specific benchmarks that must be met for further investment. “We wanted to see what happened if we took out that one variable, profit. Our proof of concept, finally, was with a drug for visceral leishmaniasis that we got down to $10 a dose.”

Hale is a scientist who recognizes the limitations of science. She emphasized that “the obstacles are not technological but human obstacles: lack of will, political challenges, competing priorities, not making a decision to commit. My end goal was to bring the industry back to diseases of poverty, to bring the industry back to where it once was, and to
where many of the employees of the pharmaceutical industry want it to be.”

In talking about those without a voice, Hale found hers. She often is asked to speak about drug development, social entrepreneurship, philanthropy, or corporate social responsibility. But more and more she brings the conversation back to “diseases of poverty,” to those who have no voice, and to the choices we can make or not make to help them.

After the Q&A session, Hale closed by saying, “Technology is the easy part. The difficult part is after you have the technology. If you didn’t begin with thought about who the technology should impact, it will be mismatched.”

She is well on the way to proving that her idea can work: “We knew there were people who worked at pharmaceuticals who would want to help, but we had no idea there would be so many and at every level,” Hale said. “Most of them got into the field to save lives and then found that many years later they were part of an effort to help a large corporation make more money. We give them an opportunity to get back to that original impulse.”

As she told the journal
Nature
, “There is a growing appreciation that a lot of IP [intellectual property] exists that many people—the discoverers, the owners, the people in the world who are in need—all agree should be moved into the public domain, but there’s nowhere for it to go. So, let’s put it in this non-profit sector and see what happens.”
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The OneWorld Institute’s first successful drug was an antibiotic called paromomycin for visceral leishmaniasis,
which won regulatory approval from the government of India on August 31, 2006. If it is the success Hale anticipates, a new industry will likely be born.

Though OneWorld Health is a nonprofit, Hale had to make decisions with the discipline of a business executive accountable for returns on investment. “We need to ask whether anyone has the will to distribute a particular drug if we developed it today,” she told the PopTech audience. “For instance, and it’s painful to say this, we believe that developing a drug for sleeping sickness is just not an area on which we should spend our energy right now, because the countries in which sleeping sickness is an issue are at civil war and aren’t spending on public health.”

Two of the relationships that Hale has built are with Keasling and Hoffman. In 2004, the Institute for OneWorld Health received a $43 million grant from the Bill and Melinda Gates Foundation to create a three-way partnership between the Institute for OneWorld Health, UC Berkeley, and Amyris Biotechnologies to significantly reduce the cost of artemisinin. She first visited Steve Hoffman when he was still at Celera, seeking advice and funding, and later she helped lay the foundation for the investment that the Gates Foundation made in Sanaria via the PATH Malaria Vaccine Initiative.

Hale told
Nature
: “Five years at the FDA taught me one thing in particular: the success of a product depends primarily on the product team. The drug and its qualities are often secondary. There are a good number of average drugs
on the market that succeeded because they had ace project teams, that overcame every obstacle.”
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When Victoria Hale delivered a keynote address at the Social Enterprise Conference at the Harvard Business School in 2007, more than four hundred students from the B-School, the Kennedy School, and other nearby colleges filled the Burden Auditorium on a Sunday afternoon, many of them having been inspired by the speakers to consider a career in public service or the nonprofit sector.

Hale spoke quietly, as if presenting the results of academic research, but it was clear from the words she chose, as well as her track record since 2000, that a passion, perhaps even an anger, fuels her work. She again used the slide presentation to show the faces of the poorest of the poor around the world, particularly in the Indian state of Bihar. “This is the twenty-first century. Why does that happen?” she asked softly, almost as if addressing herself.

Hale told the students why she started the Institute for OneWorld Health:

The increased interest in so-called “neglected diseases,” fueled by international politics as well as the massive financial commitment of the Gates Foundation, gave Hale and her organization the perfect wave to ride.

Hale’s political savvy and practical side came through in the talk, too:

She concluded by urging the audience members to “trust the universe. If your intentions are good, the universe brings you what you need.”
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If the development of the malaria vaccine—and the trials and tribulations of Hoffman, Keasling, and Hale—were the only story of its kind, it would still be interesting and instructive. But the nature of vaccine development for those most vulnerable and voiceless, as viewed through the long tunnel of time and shaped by the lack of markets, virtually creates an ecosystem: It’s an ecosystem that serves as a breeding ground for the imaginations of unreasonable men. The life and work of Peter Hotez, who has also devoted a long career to pursuing a vaccine, though for a different disease, demonstrates the broad applicability of the lessons we’ve learned so far. He has worked against the same long odds, and the entrepreneurial strategies and qualities of character required for success were also the same.

Hookworm is a debilitating parasitic disease that afflicts more than half a billion of the world’s poorest children with worms. These worms, using their teeth, adhere to the inside of their victims’ small intestines, tearing away at blood vessels and feeding on hemorrhaging blood. You do not want hookworm.

Some 44 million pregnant women around the world become infected with hookworm annually and deliver babies of low birth weight as a result. These pregnancies are associated with higher than normal infant and maternal mortality. And that’s not all, for the hookworm has no particular preference for pregnant women: Overall, 740
million people a year are afflicted with this blood-sucking intestinal parasite.
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Of course, none of them will be in the United States. Like schistosomiasis and lymphatic filariasi, hookworm is a neglected tropical disease whose prevalence and persistence is related as much to economic conditions as to medical conditions.

For kids, hookworm, though not typically fatal, means stunted height and weight as well as suppressed IQ and cognition. “There are periods in life when one is wormier than other periods, and peak period of worminess is age three or four through age fifteen,” explained Hotez when I visited him at his office at George Washington University in September 2007. “In rural villages in Guatemala, or any rural village in Central America, for that matter, 100 percent of the kids will be infected. When you are feeding a hungry child, you are feeding the worms first.” Hotez is president of the Sabin Vaccine Institute, where he founded the Human Hookworm Vaccine Initiative, and he also serves as Distinguished Research Professor and Walter G. Ross Professor as well as chair of the Department of Microbiology, Immunology, and Tropical Medicine at George Washington University.

Hotez is also the only scientist in the world who is seriously trying to develop a hookworm vaccine. Despite how widespread it is, hookworm infection has received very little attention in the scientific community, and as a result, hookworm vaccine development is not only demanding but lonely work. There is not one paper in the literature that has
been written on this leading cause of growth retardation. “Some diseases have Bono or Angelina Jolie as their champions. But hookworm has only Peter Hotez,” said Hotez, underscoring the obscurity under which he labors.

Malaria vaccine researchers are competing fiercely to get to market with the first effective vaccine. Approaches vary substantially in terms of the science involved. Rival researchers are polite but mostly dismissive of one another. Still, they constitute a fraternity of sorts, often reconnecting at conferences and seminars, sharing data, and debating the latest developments. Likewise for research in AIDS and many other diseases. But for Hotez, there are no rivals, and no competing vaccine development project: “No, just me,” he told me when I asked.