Doctor Treating AIDS by Injecting Live HIV Virus : Experiment: He says non-virulent strain competes with deadly type. Experts express serious doubts.
In an experiment that has astounded members of the medical community who know about it, a Los Angeles psychiatrist is leading an effort to treat AIDS by inoculating patients with blood that contains the live AIDS virus.
The experimental therapy is designed to fight AIDS by introducing a reputedly non-disease producing strain of the human immunodeficiency virus, or HIV, into the body so that it can compete with the patient’s own virulent strains. The virus was obtained from an individual who had apparently been infected with HIV for more than 10 years but who had remained free of symptoms.
The physician, Dr. Michael J. Scolaro of St. Vincent Medical Center, said in a written statement Friday that all the patients injected with the blood had volunteered and had “already failed both approved and experimental therapies” and were facing death.
But leading AIDS researchers and medical ethicists raised serious questions about the scientific validity of the theory on which the study is based, as well as the safety of the experiment. They said there is no evidence that the feasibility of the experiment had been demonstrated in laboratory tests and animal experiments before it was tried in humans.
Dr. Thomas Merigan, director of AIDS research at Stanford University, called the experiment “naive” and a “kind of desperation thing.”
Dr. Alexandra Levine, a leading AIDS researcher at the USC School of Medicine, said she was “very worried about deleterious effects.”
Albert R. Jonsen, chairman of the department of medical history and ethics at the University of Washington School of Medicine in Seattle, said, “At first sight, the whole thing looks screwball.”
Scolaro, who declined to be interviewed, wrote that the “preliminary findings” represented a “potential therapeutic modality, which thus far, has been overlooked in AIDS research” and that “each patient volunteered to participate in this study after carefully reviewing the therapeutic options available to them at the time and the possible risks of the experiment.”
A brief account of the research was published last month in a little noticed five-paragraph letter in The Lancet, a British medical journal, under the title “Potential molecular competitor for HIV.”
The experiment began last summer and is continuing. It involves 11 severely ill AIDS patients who were getting worse despite treatment with AZT and other drugs.
The patients “provided informed consent and agreed to discontinue all antiviral treatment,” according to the letter. Subsequently, they each received two inoculations of less than a teaspoon of whole blood from the apparently healthy HIV-infected individual.
After 41 weeks of follow-up, four patients have improved, three had mixed responses, three regressed and one died, according to a press release issued when the letter was published on March 23.
All 10 survivors had laboratory evidence of increasing immunity, according to the letter. Those who improved had increased amounts of a protein found in the reputedly harmless AIDS virus strain. No new symptoms were noted, aside from short-term muscle aches, fever and diarrhea.
The researchers described the results as encouraging, but other AIDS experts said it was impossible to draw any conclusions one way or the other from their data.
The letter was signed by Scolaro, Roy Durham of Los Angeles and George Pieczenik, a molecular biologist from New York City who devised the theory on which the research is based. They have formed a Los Angeles-based research collaboration known as Immuvax.
Scolaro is the director of AIDS Research at the Los Angeles Oncologic Institute, which is affiliated with St. Vincent. He is a psychiatrist by training but spends most of his time treating AIDS patients, according to other physicians at the hospital.
In a telephone interview, Durham, who is not a physician, said the researchers did not want to provide details of their experiments because their work represents “a fragile undertaking” and because they had offered an exclusive to a reporter for another newspaper.
Vaccines to prevent disease frequently contain weakened viruses or bacteria that boost the immune system so that it can ward off the effects of more virulent germs. Examples are the oral polio vaccine and the measles vaccine.
In addition, Levine and Dr. Jonas Salk, the polio vaccine pioneer, are testing an approach to HIV treatment in which patients receive injections of chemically inactivated AIDS virus particles that are designed to strengthen their immune systems. These injections do not contain live AIDS virus.
But experts in infectious diseases said it was quite a different matter to suggest that one strain of the AIDS virus could displace another that already had successfully invaded the body.
“I know of no virus where you have these kinds of competitions,” said Merigan, of Stanford. “There is no precedent in animal virology for it.”
Several researchers, including Dr. Harold Jaffe of the U.S. Centers for Disease Control in Atlanta, said that there is no proof that non-disease producing strains of the AIDS virus exist.
“The authors seem to assume that HIV from a person who has been infected for a long period of time but remained healthy is not capable of causing disease,” Jaffe said. “I don’t know any reason to believe that is true.”
Jaffe also said that researchers had not proved that the 11 patients had even become infected with the supposedly harmless AIDS virus.
Unlike nearly all medical experiments on patients currently being conducted in the United States, the Immuvax research was not subject to independent review by experts before it began. Such groups, variously known as human subjects committees or institutional review boards, assess the scientific validity and safety of human tests.
Leading medical ethicists acknowledged that fully informed patients have the right to volunteer for potentially high-risk experiments. They said it was not sufficient for the investigators to rely solely on their own judgments and those of their patients, which may be colored by self-deception and wishful thinking.
This experiment “would not pass muster on a peer-review basis either on background research done or methodological requirements,” said Arthur Caplan, the director of the Center for Biomedical Ethics at the University of Minnesota in Minneapolis.
Caplan added: “I don’t think the consent of the (patients who participated) is enough. People who are desperately ill will do desperate things. . . . (Peer review) lets you step back and make sure that someone’s belief in a pet theory is not skewing their ability to see whether they are ready to apply it.”
Dr. David Winsor, chairman of the institutional review board at St. Vincent, said that Scolaro’s experiment had not been reviewed because the research was being conducted in his private medical office, not in the hospital.
“The institutional review board has no say over what is done in physicians’ offices,” Winsor said. From the standpoint of the review board, “you can do anything you want out of your office.”
At most institutions, particularly university hospitals, no such distinction is made. Research on hospitalized AIDS patients as well as those who are treated as outpatients is reviewed by a human safety committee.
