San Francisco Chronicle - Monday, December 3, 2001
Tom Abate

Even now, researchers at VaxGen in Brisbane are in the final stages of testing an AIDS vaccine that originated with a 1984 experiment at South San Francisco's Genentech. Yet VaxGen won't know until this time next year whether the vaccine wards off HIV infections or turns out to be a dud.

Such persistence and dedication are central themes of a new book, "Big Shot: Passion, Politics and the Struggle for an AIDS Vaccine." Author Patricia Thomas, a medical writer based in Boston, spent five years creating this dishy yarn that begins in the early '80s, when Genentech and Emeryville's Chiron started rival AIDS vaccine efforts.

"I actually thought the first chapter should have been called the girls against the guys," joked Thomas, who said women scientists played key roles at Chiron, while Genentech had a macho hierarchy.

The women who ran Chiron's early AIDS vaccine effort were Kathelyn Steimer, who worked tirelessly until she succumbed to cancer in 1996, and Nancy Haigwood, who is still working on AIDS vaccines, though now at a Seattle research institute.

At Genentech, the early protagonists were men, led by Phillip Berman, who continued his AIDS studies in the face of hostility from corporate brass, who thought vaccines were costly longshots that didn't have the profit potential of drugs.

"Big Shot" recounts how the rival teams pushed their vaccines through the early stages of testing with help from the National Institutes of Health, which picked up most of the cost of recruiting volunteers for the study.

The vaccine effort reached a critical stage in 1994. NIH had supported the first two stages of human clinical trials. But a third and final round of tests were required. These Phase III studies carried a price tag of as high as $60 million.

Chiron and Genentech expected NIH to pick up the tab for the tests, but the federal agency, whose mission is to fund basic research, wasn't sure that funding Phase III clinical trials was government business.

"At this point, remember, there were no approved AIDS medicines and the AIDS activist community wanted treatment research as the top priority," Thomas said. "There was no constituency of healthy people carrying placards demanding NIH keep them safe."

Thomas details the tragicomic process that culminated on June 17, 1994, when an NIH committee recommended against government funding for the AIDS vaccine trial -- to the delight of AIDS activists who had packed the meeting to pan the vaccine tests. TV crews filmed the decision.

Dejected vaccine supporters left the meeting expecting to see their defeat on the evening news. But their struggle had been eclipsed by an event of greater significance that day -- June 17th was the night Americans watched the surreal image of O.J. Simpson's white Bronco being chased down a Los Angeles freeway.

In the wake of that 1994 NIH decision, AIDS vaccines could have become yesterday's news. Chiron scaled back its effort, and the project lost its prime champion after Steimer's death. Genentech gutted its program, transferring Berman and leaving just one person on the project -- noted epidemiologist Donald Francis, who had joined Genentech to work on the vaccine.

As it turns out, that was enough. Thomas said Francis used his personal clout to revive Berman's project. Francis had been the hero of "And The Band Played On," the story of the AIDS epidemic by now-deceased Chronicle reporter Randy Shilts. In the 1993 HBO movie based on the book, actor Matthew Modine portrayed Francis in his early effort to check the spread of HIV. By 1995, Francis had leveraged his poster-child status to convince Genentech to let him create a separate company, VaxGen, to handle the development of the AIDS vaccine.

Today, with Francis as president and Berman research chief, VaxGen is conducting one Phase III clinical trial in the United States and a second study in Thailand of the vaccine first spawned in a Genentech lab some 17 years ago.

In the United States, VaxGen is tracking 5,400 volunteers, virtually all gay men. Two-thirds have been getting vaccine shots every six months. The other third are getting placebo injections.

By late 2002, after three years of monitoring, VaxGen should know whether the vaccine prevented or minimized HIV infections through sexual transmissions in the vaccinated group.

A similar study is under way in Thailand, where 2,400 injection drug users are being tracked to determine whether the vaccine prevents HIV transmission by needle. That study is about 9 months behind the U.S. trial.

Wall Street is taking note of VaxGen. UBS Warburg analyst Geoffrey Harris says the company is four years ahead of its nearest rivals and stands a "reasonable chance" of success. VaxGen recently hired a new chief executive, Lance Gordon, a vaccine industry pro from Acambis, the British firm that just landed the contract to supply the United States with smallpox vaccine.

While VaxGen keeps its fingers crossed that its AIDS vaccine works and gears up to go commercial, Thomas looks back at the long quest and extracts a simple lesson.

"It all boils down to a few incredibly tenacious people who refused to give up," she said.

Thomas was talking about AIDS vaccines, but as I look out at the biotech universe, I see these same qualities in many different companies. Just last week I talked with one biotech exec about a project that recently ended in failure after 10 years. I can hardly imagine the dedication it takes, at a personal or corporate level, to stick with something that long, or how people pick themselves up after such disappointments.

But that's what people in this industry do all the time to get breakthrough medicines on the market.

Thomas will be appearing at 7:30 p.m. tomorrow at A Different Light bookstore, 489 Castro St. in San Francisco.

If you're interested in AIDS vaccines, you might also want to check out "Shots in the Dark," by Jon Cohen, or read Chronicle science writer David Perlman's Feb. 4 review of the book. Click here for the review.

CALIFORNIA CLONING: A state Senate committee will hold a hearing in Sacramento on Jan. 15 to review the law that makes human cloning illegal in California. The law was passed in 1997 in reaction to the cloning of Dolly the sheep, and will expire at the end of 2002 unless the legislature extends it.

State Sen. Dede Alpert, D-San Diego, expects the hearing to attract a lot of attention given the recent furor over the cloning of a human embryo by a biotech company in Massachusetts.

The hearing will review a report by a state advisory commission of ethicists, scholars and biotech officials. Creation of this panel was called for under the original legislation, authored by former state Sen. Pat Johnston.

"We thought the legislature would need some expert help the next time it looked at cloning," said Johnston, now a private citizen.

In August, I reported that the 12-member panel, led by Stanford law professor and cloning expert Hank Greely, would recommend that California extend its ban on human cloning for reproductive purposes. But the committee will unanimously recommend that California make an exception to permit the cloning of human embryos in connection with stem cell research.

Informed sources say the committee still intends to make those recommendations.

Neither Alpert nor her staff on the Senate Select Committee on Genetics, Genetic Technology & Public Policy have seen the report yet. The state Department of Health Services, which has provided staff support for the commission, has only just finalized the recommendations, said one source. Alpert has already sent DHS Secretary Diana Bonta a letter requesting the report be sent to the legislature by the year-end deadline specified in the 1997 legislation.

Having read the draft report, I think the committee volunteers have done an excellent job of laying out the technical, legal and ethical issues involved in cloning, and explaining the differences between reproductive and research cloning. I look forward to Jan. 15 when the State Senate puts their report into the public domain.
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