FEDERAL INQUIRY FINDS MISCONDUCT BY A DISCOVERER OF THE AIDS VIRUS

By Philip J. Hilts

New York Times 31 Dec. 1992

After three years of investigations, the Federal Office of Research Integrity today found that Dr. Robert C. Gallo, the American co-discoverer of the cause of AIDS, had committed scientific misconduct. The investigators said he had "falsely reported" a critical fact in the scientific paper of 1984 in which he described isolating the virus that causes AIDS.

The new report said Dr. Gallo had intentionally misled colleagues to gain credit for himself and diminish credit due to his French competitors. The report also said that his false statement had "impeded potential AIDS research progress" by diverting scientists from potentially fruitful work with the French researchers.

Dr. Gallo has faced questions about his scientific claims ever since the paper was published in Science magazine in April 1984. Most of his critics argued that Dr. Gallo had tried to take credit for work that the French had done and that he may even have taken the virus the French were studying and claimed it as his own. At the time, the virus was difficult to isolate and grow in sufficient quantity for researchers.

Also charged with the misconduct was Dr. Mikulas Popovic, a Czechoslovak immigrant who actually carried out the crucial AIDS experiments under Dr. Gallo.

Maintains Innocence

Dr. Gallo said today that he was not guilty and would appeal the decision. "After reviewing everything I and my colleagues have ever published on the discovery of the AIDS virus and the development of the AIDS blood test, the office of Research Integrity could only take issue with few trivial mistakes and a single sentence written by me."

The Federal conclusions are "utterly unwarranted," he said. "On a broader level," he added, "this endless and incompetent Government investigation should be of concern to everybody seeking to advance medical knowledge. My laboratory's contributions to the advancement of medical science are undisputed. For the past three years, however, I have spent a substantial amount of my time responding to issues" raised in the investigations.

The Office of Research Integrity was created this year in the Department of Health and Human Services to handle the final review of scientific misconduct cases within agencies like the National Institute of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention. The only remaining step for Dr. Gallo is to appeal the case to a judicial board within the department.

Little Credit for French

The report said Dr. Gallo intentionally misled scientific colleagues by saying he had grown an AIDS virus in his laboratory for study and he had not grown or studied a similar French strain of the virus. In fact, Dr. Gallo himself had grown the French virus and used it in furthering his own research, the report said.

While searching for the cause of AIDS, Dr. Gallo had received a sample of a virus being studied by French researchers and had worked extensively with it to extend his own discoveries, the Federal report concluded. Dr. Gallo left little credit for the French scientists in his 1984 paper because he said he had not been able to grow enough of the French AIDS virus: It "has not been transmitted to a permanently growing cell line for true isolation and therefore has been difficult to obtain in quantity," he wrote.

Dr. Gallo has said that this sentence meant simply that the virus was hard for anyone to grow it, not that he himself had failed to grow it. In fact, investigators showed that the French virus had been grown in cell lines in Dr. Gallo's own laboratory, and worked with there.

Referring to the sentence, the new report said, "Dr. Gallo falsely reported the status of L.A.V. research when he wrote the statement, and this constitutes scientific misconduct." L.A.V. refers to the French strain of the AIDS virus. The report went on, "The explanations that Dr. Gallo proffered for the statement are neither credible when the evidence is considered, nor do they vitiate the impropriety of falsely reporting the status of L.A.V. research.

In addition, the report found that Dr. Gallo warranted censure on these four other counts:

• Referring to his role as a referee for a different article submitted to a journal by his French competitors, in which he altered several lines to favor his own hypothesis about the AIDS virus, the report said the revisions were "gratuitous, self-serving and improper."
• As to the many errors in the 1984 paper, which was co-authored with Dr. Popovic, the report concluded, "In light of his role as senior author, Dr. Gallo must bear substantial responsibility for the numerous discrepancies, including four instances of scientific misconduct attributed to Dr. Popovic."
• On the standards of Dr. Gallo's laboratory record-keeping, the report said, "Especially in the light of the ground-breaking nature of this research and its profound public health implications, O.R.I. believes that the careless and unacceptable keeping of research records reflects irresponsible laboratory management that has permanently impaired the ability to trace the important steps taken."
• Dr. Gallo, the report said, also failed to determine in a timely way the exact origin of some of the crucial cells in which he grew the finicky virus. Like the viruses themselves, the cells were also found to have been borrowed from another scientist without giving him due credit in the paper. Later Dr. Gallo also refused to share the cells freely with other scientists trying to duplicate the important work, the report said.

Inquiries Begun in 1989

The dispute over Dr. Gallo's claims became so linked to national scientific prestige that the Presidents of France and the United States attempted to end the conflict in 1987 when they agreed to a 50-50 split of credit and patent royalties from work with the AIDS virus and the blood test to detect it.

But the issue did not go away, and Federal investigations were begun in 1989, after a reporter, John Crewdson, of the Chicago Tribune wrote a 50,000-word article laying out many of the charges against Dr. Gallo and his laboratory.

An initial Federal inquiry was conducted by the Office of Scientific Integrity at the Institutes of Health. That office examined all of the notes from Dr. Gallo's laboratory on the AIDS research and interviewed scores of people involved in the work. That office's report was turned over to the Office of Research Integrity.

Dr. Gallo has denied any wrongdoing in the most vehement terms. He has also alleged that there is a conspiracy to discredit him and asked why it is only his laboratory being investigated, and not that of Dr. Luc Montagnier, the French laboratory leader who has largely escaped detailed scrutiny.

What's at Stake

In the great public health catastrophe of AIDS, the story of how the virus that causes AIDS was isolated and a test for the presence developed might be of only historical interest were it not for the fierce and unyielding pride of the researchers and the millions of dollars the two Governments receive annually in royalties from the manufacturers of the blood tests.

In a recent plea to the American Government, lawyers for the Institut Pasteur in Paris, where the French work was done, asked the United States to turn over half of the profits from the blood test - about $50 million since 1985.

Dr. Gallo earns about $100,000 a year from the royalties on the blood test, as does his French counterpart, Dr. Montagnier.

Michael Epstein, a lawyer for the Institut Pasteur, said in a telephone interview today that in light of today's report the French would ask the United States to renegotiate its agreement giving equal credit to each country, so as to assign a larger share to France.

"this ought to move the U.S. Government to action," he said. "Dr. Gallo has always told us that he was never able to grow L.A.V. One of the most important reasons why Pasteur settled the dispute in 1987 was that Dr. Gallo told us that and said there was no evidence to the contrary. Now even the U.S. Government is saying that he knowingly lied."

The new report reversed the findings by Dr. Bernadine Healy, director of the National Institute of Health and Dr. Gallo's superior. After receiving the report from the Office of Scientific Integrity, she concluded in September 1991 that Dr. Gallo did a number of things wrong but was not guilty of the most serious charge, that of scientific misconduct.

Investigators at National Institutes of Health and in Congress disagreed, as did a panel of independent scientists. *

Years of Scientific Dispute 1983 French scientist under Luc Montagnier at Pasteur Institute report discovery of a virus that might be the cause of AIDS. 1984 Ignoring French claim, U.S. scientists at National Institutes of Health under Dr. Robert C. Gallo announce discovery of such a virus and proof that it causes AIDS. 1985 A blood test for antibodies to the AIDS virus is licensed. The French sue the U.S. Government over the credit for the discovery of the virus. 1987 President Ronald Reagan and Prime Minister Jacques Chirac announce an agreement on sharing credit and divide royalties for the blood test. 1989 A Chicago Tribune article suggests that Dr. Gallo improperly took credit for the Montagnier discovery. MARCH 1990 A Tribune report asserts that Dr. Gallo's virus was probably identical to the Pasteur Institute virus. OCTOBER 1990 the National Institute of Health says it will open a full-scale investigation of the matter by the Office of Scientific Integrity because a preliminary investigation suggested the possibility of misconduct. MAY 1991 Dr. Gallo formally concedes that the viral cultures were probably contaminated by the French samples but maintains that he is a co-discoverer. SEPTEMBER 1991: Preliminary report by Office of Scientific Integrity finds evidence of misconduct by Dr. Gallo. Final report holds that he is not guilty of misconduct but deserves censure for permitting lapses and misrepresentations by those under him. MARCH 1992 New investigation of charges of perjury and patent fraud announced by Inspector General of Department of Health and Human Services, the General Accounting Office and a house subcommittee. DEC. 30 1992 Report of Office of Research Integrity of Department of Health and Human Services says Dr. Gallo grew a sample of Montagnier's virus in his own laboratory, misled colleagues to gain credit for himself.