Dr. Seth F. Berkley was one of the founders of the International AIDS Vaccine Initiative in 1996. The organization is now leading worldwide efforts to find an AIDS vaccine, having spent $100 million on research so far. IAVI has five vaccine candidates in human trials. Berkley, formerly the associate director of the Rockefeller Foundation's health-sciences division, is also an adjunct professor of public health at Columbia University and Brown University's adjunct professor of medicine.
He spoke with BusinessWeek Senior Writer Catherine Arnst about the science and politics of developing an AIDS vaccine. Following are edited excerpts of their conversation:
Q: How did you get involved in the AIDS-vaccine effort?
A:I'm an epidemiologist who trained in internal medicine. I was asked by the Carter Center to go to Uganda in the late 80s to help rebuild the health system. I'm not an AIDS person, but I could see it was devastating that nation, and I started asking simple questions about AIDS. I ended up doing a national survey, and I couldn't believe that these figures were right. That was my first understanding that this disease is like the Black Plague.
Then I was working at the Rockefeller Foundation when they said the AIDS-vaccine effort is dead. I said, "That can't be so." [The flagging vaccine effort] was for a funny set of reasons. Activists wanted treatments and pushed the National Institutes of Health, and investments ended up going into drugs and away from vaccines. Plus, vaccines were politically controversial, etc, so no one was doing it.
IAVI was formed with the understanding that only a vaccine can end the disease. And that this is the worst pandemic since the 14th century. The real innovation in creating IAVI is that we created a public-private partnership. We realized that the private sector wouldn't do it on its own, but they were absolutely necessary to the effort.
Q: What's the most challenging obstacle to the development of a vaccine?
A:A: The science. But it's also the understanding that political and public policy is part of the equation. In a way, saying that a vaccine is very difficult or impossible is a self-fulfilling prophecy. The entire world is spending very little on AIDS vaccines, and that's a guarantee that we'll never get there. For years, there was almost no effort. Now we have an absolute effort rooted in science and innovation and advocacy and public policy.
Vaccinology was, up until now, an empiric science, based on observations on what spreads disease. That has been through history. But we need to have the best science as well. We need to bring all the tools of science to bear on the problem.
Q: What's IAVI doing in this regard?
A:Our biggest innovation is probably that we're working on multiple vaccine candidates. We rapidly move promising candidates ahead into human tests, and we're moving all of them in parallel rather than focusing on just one approach.
We're also trying to think about new ways of solving the fundamental problems. Traditionally, these problems were solved by individual workers working in separate labs. But we need a different model to solve big problems. We came up with the idea of consortiums of researchers under an industrial project manager. Our output isn't about publishing papers, but in coming up with a product. We're doing that on what we think is the greatest single challenge, which is broadly neutralizing antibodies [that can block a virus]. That's the big science nut we're trying to crack.
Q: Has it been difficult to convince researchers to work together in this fashion?
A:It's difficult to get researchers to work together in the sense that it's difficult to marry the industrial and scientific models. Both are important, but we must bring [them] together. If we only did basic science or practical applications we wouldn't get there.
Q: What's the biggest scientific hurdle to cross at this point?
A:The problem is we know this virus mutates. We're in that race against time before it changes into something that's not susceptible to the treatments available now. It's a very real problem. I think we have a window right now. Yes, we've got drugs, but every year in the U.S. there are 40,000 new infections, and we'll have a massive increase in deaths again. We have to continue to innovate. We need a vaccine as much in the West as in the developing nations.
Q: How will a vaccine be administered in the developing world?
A:The problem isn't that there aren't things you can do. The problem is prevention alone isn't enough. The timeline for this type of innovation is longer than that. You keep pushing, get as broad a consensus as you can. We always deeply discount prevention. Vaccines have not had champions. There has been a massive increase since IAVI -- but still less than 10% of AIDS spending is on vaccine research.
Nevertheless, we have a set of vaccine candidates, and we'll have test results on those in 2007-08. These are still probably not the final candidate, but they're a good start. Hopefully we'll have something by the end of the decade. If those are a moderate success, then we can develop better ones. If they're utter and abysmal failures, we must have others in the works that we can move forward. That's really the challenge, making sure we have a complete set of candidates.
Q: Is sub-Sahara Africa a lost cause?
A:If you look at how we think of development, we say, "Let's help Africa build roads or schools." But most developing countries have that the ability to do those things. [Most African countries] don't have the ability to push the limits of new technologies. African scientists are very good, but they don't yet have the skill sets to develop an AIDS vaccine. This is the most important [of the] development efforts we can do there.
When the histories of the 21st century are written, AIDS will be one of chapters, and one of the sub-chapters will be "Why did it take so long to get a vaccine?" And the answer will be because it took time for the public and private sector to work together.