The Miami Herald, Inc.; Thursday, September 25, 1997
Brigid Schulte, Herald Washington Bureau

Yet at least 50 doctors and activists this week offered themselves up as human guinea pigs, largely to protest the glacial pace of vaccine research.

The risks are enormous. The science is unclear. And should the government approve such a trial, it's almost certain that some of the volunteers will become ill with AIDS, suffer and die.

Helen Miramonter, a nurse at the University of California in San Francisco, is well aware of the danger. Mother of six, two of them gay, and grandmother of 10, she is willing to put her life on the line.

"I'm 66, and a widow, so the decision was mine alone. I have lived a full and happy life. I hope to live a lot longer because I have a lot more work to do. But we've got young people, 15-year-olds, being infected every day," she said. "We're talking about wiping out whole societies of young people just beginning their productive life."

With 8,000 people a day becoming infected with the human immunodeficiency virus (HIV), many volunteers say they are willing to take the risk. They are meeting today with hesitant government officials and scientists at the National Institutes of Health (NIH) to try to persuade them to approve the trial.

The tests would be carried out by the International Association of Physicians in AIDS Care, based in Chicago.

Not all volunteers known

Because of confidentiality concerns, the names of all the volunteers are not known. But some have acknowledged their participation, among them Dr. Bernard Hirschel, chairman of the 12th World AIDS Conference in Geneva, and Jose Zuniga, who was drummed out of the Army for admitting he is gay.

Miramonter worked in the civil rights and peace movements in the 1960s. She has fought for migrant worker rights. And, in the early fearful days of AIDS, when people were unwilling to touch AIDS patients or breathe the same air, she volunteered to nurse them. Now, she sits on the president's advisory council on HIV and AIDS.

That doesn't mean she's without fear.

"It is terrifying for people, but this is just part of my responsibility, my role as a nurse," Miramonter said. "And I'm part of an older generation, one that believes it's your duty to turn around and take care of the next."

And the only way to do that with AIDS is to risk human lives in a vaccine trial. "Even trial failures give us answers," she said. Even if she is that failure, "I'll have no regrets."

`Mouse on a treadmill'

But that is exactly the risk that many scientists and government agencies have not been willing to take.

Only a few companies are trying to develop an AIDS vaccine. And the virus is so complicated that most vaccine research only raises more questions.

"We're like a mouse on a treadmill," said Dr. William Heyward of the Centers for Disease Control and Prevention. "We're running like hell and we're going nowhere."

Still, Heyward and other researchers say it is simply too soon to start injecting people with a weakened HIV virus.

"While we all laud the altruistic motives of the people who want to volunteer, from the perspective of the substantial safety issue raised, this is premature," said Dr. Anthony Fauci, who heads the NIH's AIDS section.

If the volunteers can persuade the government to go forward with a study, the first step would be a small human trial, with fewer than 50 people, to test whether the vaccine itself is safe.

The next stage is a large field study to test whether the vaccine worked, involving thousands of people, some of whom would be considered at risk of contracting the AIDS virus through unsafe sex or IV drug use. One group would be vaccinated and a control group would not. Researchers would watch, over the years, to see if the vaccinated group had fewer HIV infections than the control group.

Not worth the risk

"I would not volunteer and I'm not sure I would volunteer any of my patients at this point," said Dr. Margaret Fischl, director of the Comprehensive AIDS Program at the University of Miami's School of Medicine, and one of the earliest AIDS researchers. "The concern, and justifiably so, is that this virus can recombine. Even a weakened strain, in layman's terms, can mutate back to a virulent virus that's fully infectious. The odds are low that it's worth the risk these volunteers are thinking of taking."

But Dr. Charles Farthing, 44, of Los Angeles, who has cared for HIV and AIDS patients with increasing frustration, disagrees. It was he who began calling for human volunteers last month -- and volunteered himself -- to spotlight what he calls "timidity" in the scientific community.

In a meeting today with Fauci and other NIH personnel, Farthing and others are hoping to convince the government that now is the time to move forward. There will always be uncertainty, Farthing argues. There will always be risk. But how much longer can the world, particularly the growing infected communities in Africa and Southeast Asia, wait?

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