Test of HIV in Humans at Issue

Physician Charles Farthing has spent more than a decade battling the AIDS virus in his patients’ bodies. Now, he proposes putting the virus into his own.

Farthing, medical director of the AIDS Healthcare Foundation in Los Angeles, is leading an effort to inject about a dozen healthy people, including himself, with a weakened but live strain of the virus. This, he hopes, would lead to the creation of the first vaccine to block HIV, which infects an estimated 8,000 new people every day, worldwide.

There is no guarantee that the subjects of this proposed experiment won’t themselves get AIDS and perhaps die.

But Farthing, 44, believes that animal and other studies--including the accidental injection of several patients with weakened HIV in Australia 14 years ago--have shown that the risk is minimal.

In medical research, said Farthing, who was formerly director of the AIDS treatment program at Bellevue Hospital in New York, there comes a time for an educated leap of faith.

But injecting into humans a live strain of one of the most dreaded viruses in human history? More than one person, Farthing said, has called him crazy since news broke over the weekend of his study proposal, made by a subcommittee he heads for the International Association of Physicians in AIDS Care.

He is undaunted.

“Someone has to go first,” said Farthing, who spent the morning after his proposal was made public seeing patients at the foundation’s North Hollywood clinic.

“Medicine has changed. Years ago, people took risks. Now, it’s as if medical research cannot expose anyone to any risk.

“Well, that’s why this research is going so slowly. People have to accept some risk.”

There is no argument that an AIDS vaccine is one of the major goals of world medical science, especially because the best treatments for the disease--the protease inhibitor combination therapies--are expensive and therefore difficult to obtain for Third World populations where the disease is widespread.

Dr. Michael Gottlieb, who in 1981 was the first to describe AIDS as a disease, said he certainly understands Farthing’s frustration with the slow pace of vaccine research. But Gottlieb doubts the time has come for live virus tests in humans.

“I admire Charles’ altruism,” said Gottlieb, who practices in North Hollywood. “But live, attenuated HIV could be a very dangerous creature. Even simple vaccines can have unforeseen consequences down the road.”

He said the proposal for a study would have to be carefully examined to determine its worth as research.

Gottlieb pointed out that “the only possible purpose of this kind of study would be to investigate safety”--that the weakened virus injections would not themselves bring on disease. The big question--whether a vaccinated person would actually be immune to HIV--could not be tested in this way unless vaccinated volunteers were then willing to be exposed to full-strength HIV.

Farthing agreed that safety is the key issue in his proposed test. But he also believes it’s just about the only real issue left. “The big question is not will it work, but is it safe,” he said. “It’s already shown to be effective in monkeys, and they are not all that different from us.”

He reviewed the monkey research in January at the Fourth Conference on Retroviruses and Opportunistic Infections in Washington. “The research had been so quiet,” Farthing said, “but I was very excited. I thought we have to have new trials.”

He believed the injections had spurred the monkeys’ bodies to develop antibodies to HIV, showing the weakened virus would be effective as a vaccine.

To bolster his argument, he used the example of six Australian patients who accidentally received HIV that was stronger than the strain he now proposes for his test. None of those patients has gotten AIDS, but some researchers caution that they could still develop medical problems in the future.

The researcher who did the monkey studies was not convinced that the time has come to make the leap to humans. And when Farthing suggested human trials to Robert Gallo, who is credited with the co-discovery of HIV, Gallo had concerns that went beyond possible AIDS infection.

“He suggested that HIV might cause random cancers in patients,” Farthing said. “I thought about it, and realized that I had been treating AIDS patients for 15 years, and had never seen that.”

(At a conference on women and HIV in May, however, at least one AIDS physician reported detecting unusual types of cancer in HIV-infected women).

Farthing began work on his proposal. For the August issue of the Journal of the International Assn. in AIDS Care, he wrote “A Call to Physicians” that made the case that physicians themselves should volunteer to be test subjects.

“I am asking those of you who might qualify to join me by registering as potential candidates for a live-attenuated vaccine trial that could help bring us closer to an effective vaccine,” he wrote.

At the bottom of the page was a registration form for applicants to fill out. Farthing said about 50 were returned by medical and AIDS workers.

About a dozen people, he said, would be used for initial studies.

“Some people said we should try this first on death row inmates,” Farthing said, “but I had trouble with that. I think it should be done by people who we are sure understand the risks involved.”

The next step for Farthing is a meeting, scheduled Thursday, with National Institutes of Health officials in Washington to discuss his proposal. Under federal law, he would have to win approvals from federal agencies before any human clinical trials could be undertaken. Approval would also probably be needed from an institutional review board at whatever research institution was willing to sponsor such a study.

Farthing would not rule out going forward with studies if federal agency approvals could not be obtained.

“We’ll cross that bridge when we come to it,” he said.

But he would probably find it difficult to get much support for an unapproved experiment. “The NIH has been known to cut off millions of dollars of research funds to institutions that may have been associated with research projects it turns down,” Gottlieb said.

All these matters lie ahead for Farthing, who said the publicity generated by the proposed study was unexpected. He didn’t even have a chance to alert his mother or brother, who live in his native New Zealand, that he was volunteering himself as a test subject.

Farthing did, however, talk it over with the man he lives with. “He was pretty concerned,” Farthing said with a laugh. “But not as much as his mother.”

*

Pro

‘Someone has to go first. . .The big question is not will it work, but is it safe.’ Charles Farthing, Medical director, AIDS Healthcare Foundation in Los Angeles.

Con

‘I commend these people for being altruistic in volunteering for something like this, but as a scientist, I think it’ premature.’ Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases.