Gates Won’t Fund AIDS Researchers Unless They Pool Data

Frustrated that over two decades of research have failed to produce an AIDS vaccine, Microsoft Corp. Chairman Bill Gates is tying his foundation's latest, biggest AIDS-vaccine grants to a radical concept: Those who get the money must first agree to share the results of their work in short order.

Even as AIDS researchers around the world strive toward a common goal, they do so largely independent of one another due to a mix of commercial interests, bureaucratic jostling and personal rivalries. Like most biomedical research, results of AIDS-related studies are often carried out in secrecy, with successes and failures closely held until they are published in scientific journals months later.

So far, attempts to come up with a vaccine that produces protective antibodies to block infection by the wily and shape-shifting AIDS virus have been a "miserable failure," says Nick Hellmann, interim director of HIV projects at the Bill & Melinda Gates Foundation.

Now, Mr. Gates's family foundation is putting $287 million new, five-year grants behind the notion that pooling results can surmount the massive technical hurdles that have hindered individual, sometimes-competing efforts.

"The whole field recognizes that in order to meet this humongous challenge, we have to change the way we work," Dr. Hellmann says. "There have to be better networks and collaborations. [So] we require all grantees to collaborate across a spectrum of grants."

Through such data sharing, Dr. Hellmann says, rival teams can build on successes, avoid pitfalls and eliminate redundancy. Even so, he says that a vaccine is "at least 10 years away."

The new grants were awarded yesterday to 165 researchers from 19 countries. They were selected to tackle unsolved challenges targeted by the Global HIV Vaccine Enterprise, a research alliance that declared in 2003 that fragmented vaccine experiments lack the scale to halt the AIDS pandemic now affecting nearly 40 million people world-wide.

"Traditional ways...have largely failed," says Giuseppe Pantaleo, chief of immunology at the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland. Dr. Pantaleo received a $15.3 million Gates grant to create improved AIDS vaccines piggybacked on pox viruses akin to the smallpox vaccine.

There's no guarantee these particular grants, or the Gates foundation's efforts in general, will lead to a working vaccine. But since fragmented vaccine efforts have yet to protect a single human from the pandemic that rages out of control in many regions, some supporters argue it's time for a new approach. Grant recipients and outside observers were unsure whether data-sharing requirements of the grants could pose potential legal or patent conflicts with Mr. Gates's vow to respect intellectual property. Foundation officials said this week researchers would still be free to commercialize their discoveries, but they must develop access plans for people in the developing world.

The foundation declined to make its attorney available to address these concerns.

There are four major goals to be funded by the grants: vaccines that spark neutralizing antibodies to block initial infection by HIV; vaccines that make stronger T-cell response to kill infected cells; creation of standard criteria to measure success or failure; and a new, secure Web site for sharing all the data in real time.

"Whether in academics or industry, scientists want to protect intellectual property. ... With the alliance, the shift is to say: 'No, the large enterprise is more important than the position I keep by holding my data close,'" says Steve Self, a biostatistician at the Fred Hutchinson Cancer Research Center in Seattle, which is lead investigator of a $30.1 million grant to create new adjuvants, ingredients that boost a vaccine's power. Dr. Self got a $10 million grant to create a secure central data repository to be named Atlas.

Enforced data sharing, Dr. Self predicted, "increases the pace of discovery enormously rather than waiting for the process of writing formal journal articles, waiting for them to be published, and [confirmed] by other labs." As efforts funded by the Gates grants get under way, other funders must not be lulled into complacency, warns Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition, a nonprofit community group. Activists recently have voiced concerns that the National Institutes of Health budget is flat in real terms.

Mr. Warren estimates that research efforts need more than $1 billion a year, and that the Gates grants, to be paid out over five years, will boost total annual investment to just over $800 million.

Some big names from industry and academia chose not to seek the Gates grants because they already had other funding, conflicting commercial commitments, or uncertainty about the program's impact on existing partnerships. "We had linkages that caused us to think we weren't ready to go in," says AIDS researcher Robert Gallo, co-discoverer of the AIDS virus and director of the Institute for Human Virology at the University of Maryland in Baltimore.

Dr. Gallo is funded by the National Institutes of Health, the pharmaceutical industry and other federal programs. In 2005, he co-founded Profectus Biosciences Inc., which licensed intellectual property of his lab and plans to commercialize it.

Collaboration doesn't replace the spur of competition, Dr. Gallo says. His race with Luc Montagnier of the Pasteur Institute in Paris to discover the AIDS virus led to competing claims and a lawsuit by the French for credit and a share of patent royalties from the HIV blood test.

But Dr. Gallo says he approves the notion of a megaproject for AIDS vaccines. "I tried to push for a vaccine crash program back in 1988," he says. "It used to be said the science isn't ready. But it'll be readier than if we don't do it." He added that he may apply for future Gates funding.

Another of industry's most productive AIDS researchers absented himself from the Gates grant program. "We're not participating," says Emilio Emini, vice president of vaccine research and development at Wyeth Pharmaceuticals. He adds that Wyeth's proprietary vaccine discovery program is already sufficiently funded and governed by existing grants and contracts with NIH. He says the company will continue operating its own independent research program.