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At 7:30 a.m. last Wednesday, a day after a roundtable about HIV among Native Americans, and a few hours before a discussion of spirituality and HIV, Don Francis sat on a stage at last week's HIV/AIDS Update Conference at Civic Auditorium. He was sandwiched between an anti-retroviral specialist, a microbicide researcher, and an expert on less deadly types of STDs. Francis was one of only two vaccine specialists out of 150 scientists who spoke at last week's conference. He was allowed 20 minutes to talk, a few more for questions.
Two decades after the outbreak of the "gay cancer," the AIDS epidemic has evolved its own social ecology, complete with treatment and prevention specialists, funding bureaucrats, social workers, care advocates, and half-interested politicians. At the base of this food chain lie the vaccine proponents, forced by circumstance into life as scrappy bottom feeders. Only 2 percent of the world's AIDS spending goes to vaccines. There are few vaccine activists; AIDS sufferers and their families are far more interested in treatment. Large pharmaceutical companies are only marginally interested in AIDS vaccines, and until recently, the government budget for vaccine research was a pittance.
This untoward environment has shaped a strange champion in Don Francis. If the virus that causes AIDS is an odd, fungible, indefatigable creature, then its most storied opponent is of a similar breed. When the government turned down his request to fund a massive vaccine trial seven years ago, he tapped into the venture capital boom with a $20 million vaccine startup company. Since this trial will end next summer with most experts saying it likely won't achieve the kind of positive result that would lead to a commercial drug, Francis and his company, VaxGen, have mutated again.
Francis has convinced a group of Korean companies to invest $160 million to build him a pair of bio-tech drug factories, with the promise of getting a piece of the $11 billion President George W. Bush has allocated to fight bioterror. If this creative financing end-run succeeds, VaxGen may survive well past next summer, when results of nationwide testing of its oft-maligned AidsVax vaccine become public. His company may become a commodity drug manufacturer, perhaps using the profits to develop other AIDS vaccines.
"There are other products that if they look good to go with us, we will be looking at those aggressively," Francis says.
Don Francis' persuasive genius, his brilliance as an AIDS-funding sharpie, his ability to inspire thousands of vaccine-trial volunteers and volumes of scientific scorn are exactly the traits one might expect to prevail in the bizarre, financially neglected world of AIDS vaccines.
And that's too bad, because America ought to consider the quest for an AIDS vaccine the most important project in the world.
Don Francis, a Centers for Disease Control specialist who battled the AIDS epidemic when it first broke out in San Francisco's Castro district two decades ago, has spent the past 17 years dedicating his life to a simple notion: Vaccines have eliminated previous generations' plagues, and they should eliminate AIDS. In a simpler world that might have meant a career spent grant writing, leading well-funded research teams, mounting a global vaccination campaign. Instead, it's required the skills of a physician, oil-field wildcatter, penny-stock pitchman, and international diplomat.
In 1995, after helping the South San Francisco biotech giant Genentech develop a vaccine it called gp 120, the vaccine team led by Francis applied for funding from the National Institutes of Health to conduct effectiveness trials, the last step before a drug is approved by the Food and Drug Administration. The NIH declined, saying the vaccine, which consisted of a protein designed to mimic HIV's protective shell, only created immunity against laboratory-bred HIV. It was ineffective against "wild," real-world HIV.
Rather than abandon the project, Francis convinced Genentech to spin the division into a separate company that Francis would run. He attracted $20 million in venture capital, opened offices near the San Francisco International Airport, and convinced the government of Thailand to cooperate in trials for his company's only product, the gp 120 vaccine he dubbed AidsVax. Two years ago he launched nationwide Phase 3 effectiveness trials at sites throughout the U.S. Some 5,000 U.S. volunteers have taken the vaccine. A public stock offering raised $40 million more.
The investors backing VaxGen haven't bought into just any speculative venture; they've bet on a wildly speculative one. The Associated Press last week quoted Anthony Fauci, director of the National Institutes of Health's Institute of Allergy and Infectious Diseases, akin to America's AIDS czar, as saying he didn't expect to see a successful vaccine in less than 10 years, even though results from Francis' vaccine will be available next summer, and about 30 other experimental vaccines are now undergoing preliminary trials.
The scientific obstacles to establishing an HIV vaccine represent one of the most vexing puzzles in science. Much vaccine work that goes on hasn't progressed past the level of basic, curiosity-driven research. Developing a vaccine that is safe, while perfectly immunizing against all strains of HIV -- a virus famous for its endless mutations -- may be beyond the ability of current biological science. Most experts in infectious disease, in fact, believe Francis' VaxGen trial will fail.