Source: New York Times af Barry Meier
A leading AIDS researcher is under investigation by Federal officials after allegations that he may have overstated the therapeutic effects of an experimental vaccine against the deadly disease.
The investigator is Dr. Robert Redfield of the Walter Reed Army Institute of Research. Central to the inquiry are statements made by Dr. Redfield earlier this year that use of the vaccine, a protein known as gp-160, might reduce blood levels of H.I.V., the virus that causes AIDS, in those already infected, said Major Rick Thomas, a spokesman for the Defense Department which is conducting the investigation.
The vaccine, the first approved by the Federal Government for testing in people, has been more widely tested than any other candidate vaccine against HIV. Unlike typical vaccines, which prevent a virus from establishing itself in the body, gp-160 is designed to help the immune system fight an established infection.
Interpretation at Issue
“The validity of Dr. Redfield’s data is not in question,” said Major Thomas. “The question is whether that data has been interpreted and presented properly.”
Dr. Redfield is perhaps the scientific community’s leading proponent of gp-160 as a treatment for those already infected by H.I.V. Major Thomas said the allegations against Dr. Redfield were bought by fellow researchers.
Dr. Redfield, who is chief of the department of retroviral research at Walter Reed, did not respond to several telephone calls to his laboratory this week. However, he has apparently backed away from his earlier comments in recent months.
Major Thomas said that the military’s inquiry will review all research performed by the Army on gp-160. Initial tests have shown it to be safe and indicated that it might stablize the conditions of those infected by H.I.V. The Defense Department is the lead Federal agency working on gp-160 which is currently being administered to about 500 patients at 17 test sites around the country.
“We are awfully proud of what we have done,” said Major Thomas. “But we want to make sure that everything that we have done is accepted by the scientific community. This may be just a difference in interpretation of the data.”
Another Dispute on Vaccine
The disclosure of the investigation comes on the heels of another controversy involving gp-160. Last month, Congress approved spending $20 million on expanded tests of the vaccine in humans. But several top Government scientists denounced the move because lobbyists representing MicroGeneSys Inc., the company that pioneered development of gp-160, engineered the appropriation by directly lobbying Congress without the knowledge of Federal researchers.
A blue ribbon panel of AIDS researchers convoked by Dr. Bernadine Healy, the director of the National Institutes of Health, is scheduled to meet today to review whether the expanded gp-160 tests should go forward. The top officials of N.I.H., the Defense Department and the Food & Drug Administration have five months to make a decision on the issue. Should they decide to delay or forego the tests, Congress has directed that the $20 million will still go to AIDS research.
The tests at issue in the military inquiry were preliminary and lacked some of the controls being used in the gp-160 trials now underway.
Major Thomas said the inquiry, which was disclosed to Army researchers about two weeks ago, is expected to take about 60 days.
Conflicting Views of Data
The dispute over Dr. Redfield’s interpretation of gp-160 test data apparently started soon after an international meeting of leading AIDS reseachers in Amsterdam. It was there that Dr. Redfield reportedlowered H.I.V. levels in a small number of patients treated with gp-160.
But in August, researchers associated with Dr. Redfield reviewed that same data and saw no reduction in viral blood levels, according to a memo written at the time by Dr. William McCarthy, the director of the department of biostatistics at the Henry M. Jackson Foundation for the Advancement of Military Medicine in Rockville, Md. The organization supports Government research and at times shares laboratories with military scientists like Dr. Redfield.
Dr. McCarthy said that he had not brought the accusations against Dr. Redfield. Dr. Vahey could not be reached for comment.
The existence of Dr. McCarthy’s memo was first disclosed in the October 24 issue of New Scientist, a British science periodical. The magazine also reported that in September, soon after Dr. McCarthy’s memo was written, Dr. Redfield gave a presentation in which he backed away from his early claim and said that gp-160’s effects on viral blood levels were unclear.