Apathy, Outrage Accompany Leak Of Unofficial Report On Gallo Case

Document questions conduct of HIV researcher and NIH,but many grass-roots scientistssay they are tiring of the case. ROBERT GALLO: The NIH researcher calls the subcommittee report "bizarre" and a personal attack on him. Grass-roots scientists have had a muted response to the underground release of an investigative report on alleged misconduct by National Institutes of Health HIV researcher Robert C. Gallo prepared by a former majority congressman's staff. Notwithstanding the relative lack of

Apr 3, 1995
Paul Kefalides


Document questions conduct of HIV researcher and NIH,but many grass-roots scientistssay they are tiring of the case.

ROBERT GALLO: The NIH researcher calls the subcommittee report "bizarre" and a personal attack on him.
Grass-roots scientists have had a muted response to the underground release of an investigative report on alleged misconduct by National Institutes of Health HIV researcher Robert C. Gallo prepared by a former majority congressman's staff. Notwithstanding the relative lack of attention given the matter by the scientific community at large, those mentioned unfavorably in the unofficial report have voiced outrage that it was made available to the public at all.

At the same time, several outspoken scientists believe the report represents a successful mission to determine what happened in the decade-long series of events surrounding the misconduct charges. They are hoping that their efforts to disseminate the text will eventually spur action by science leaders.

In general, although the report harshly criticizes the United States government's handling of the issue calling what transpired a "cover-up" most scientists seem to prefer to forget the whole episode.

"The 'nobody cares' response is from the fact that this investigation went on too long," says Priscilla Schaffer, a Harvard Medical School virologist and a member of an NIH Office of Research Integrity (ORI) committee that investigated Gallo from 1990 to 1992. She adds: "I am most frustrated that this case never came to a satisfactory conclusion."


BACKING AWAY? Debate continues over whether Rep. John Dingell's ambiguously worded letter was a disavowal of his staff's report.
The report an investigation of charges that Gallo misappropriated the HIV virus from France's Institut Pasteur (IP), and of NIH officials' response to the allegations was leaked from the House Energy and Commerce Committee's subcommittee on oversight and investigations, chaired by Rep. John Dingell (D-Mich.), in January, as he vacated the committee chairmanship.

The document, entitled "Institutional Response to the HIV Blood Test Patent Dispute and Related Matters," finds that Gallo, chief of the National Cancer Institute's Laboratory of Tumor Cell Biology (LTCB), and his staff "knew or had reason to know that the virus they were working with and claimed as their own was the IP virus." It further concludes that, in looking into the charge, administrators at the Department of Health and Human Services (HHS) "conducted a parody of an investigation; they did not seek the truth but rather sought to create an official record to support the claims of Gallo et al."

An April 1984 HHS press conference announced that Gallo had discovered the virus and an HIV antibody blood test. The LTCB scientists were awarded a patent for the blood test in May 1985. The subcommittee report notes that the U.S. Patent and Trademark Office (PTO) awarded the patent "despite the fact that another patent application for substantially the same invention the IP application had been submitted to PTO months before the submission of the Gallo application."

In 1985-86, French representatives filed four legal proceedings, initiating a two-year battle between the two governments. In March 1987, President Ronald Reagan and French Prime Minister Jacques Chirac signed a settlement agreement dividing the royalties but awarding a disproportionate share to the U.S. The agreement was renegotiated to a 50-50 split in 1994. Gallo personally continues to receive $100,000 a year in royalties, the maximum allowable for government employees.

Since February 1, the report has been accessible on the Internet through the personal home page of NIH's Walter Stewart (http://nyx10.cs.du.edu:8001/_wstewart), who on his own time has persisted in investigating misconduct cases despite the disapproval of the institutes' administration (F. Hoke, The Scientist, Feb. 6, 1995, page 3).

Stewart notes that he has been receiving about two or three E-mail messages a week from those who have accessed the text. Generally, he remarks, those who have responded to him are appalled by the report's conclusions: "Everybody who takes the time to read the report is horrified by the [findings]."

Gallo and his supporters counter that because the document was not released through appropriate government channels, it does not deserve his scrutiny or a substantive response. He calls the report and investigation "bizarre" and a personal attack on him.

Edmund Tramont, director of the Medical Biotechnology Center at the University of Maryland, was formerly a Department of Defense staffer advising a National Academy of Sciences (NAS)- nominated panel headed by Yale University chemist Frederic Richards, which ultimately produced a report critical of Gallo. Tramont, however, believes the process has been unfair to Gallo and his top AIDS scientist, Mikulas Popovic. Tramont does not find the subcommittee report credible and also believes the document to be a personal attack: "None of it is truth. It's vindictiveness."

But the report is applauded by Gallo's weary critics, many of whom have publicly criticized the outcome of past investigations, none of which, in its final version, has concluded that Gallo was guilty of misconduct (see accompanying chronology). One of them, former Centers for Disease Control and Prevention (CDC) researcher Don Francis, strongly supports the subcommittee's findings: "All I know is, this is the most extensively researched document so far."

The report 267 pages long, plus a 65-page executive summary is the result of a three-year investigation by Dingell's staff. In addition to a review of paperwork from investigations by NIH's former Office of Scientific Integrity (OSI) and, subsequently, ORI, the subcommittee took hundreds of hours of original testimony from 50 witnesses, according to Suzanne Hadley, a former Dingell subcommittee investigator and one of the report's five authors.

"The total documentation could fill two file cabinets," notes Peter Stockton, a former investigator for the subcommittee. Regarding charges that the Gallo team knew they were representing the IP virus as their own, the report states, ". they performed their seminal experiments, and even more, within a few weeks of the announcement of those experiments, that make compelling the case that there was something to hide, and that they made every effort to do exactly that."


'SAVE BOB'? Former NIH director Bernadine Healy denies charges that she aimed only to protect Gallo.
It also is sharply critical of the response of top NIH administrators, including former NIH director Bernadine Healy, who, it says, "did everything she could to protect her superstar, senior scientist."

May 1983:
Scientists at the Institut Pasteur (IP) publish a paper identifying a virus they call LAV that they have isolated from AIDS patients (F. Barre-Sinoussi et al., Science, 220:868-71, 1983). In the same issue, Robert Gallo and associates publish papers on the relationship between the leukemia virus HTLV-I and AIDS (E.P. Gelmann et al., Science, 220:862-5, 1983; R.C. Gallo et al., Science, 220:865-7, 1983).

July 1983:
IP scientists send virus isolates to Gallo's Laboratory of Tumor Cell Biology (LTCB) at NIH.

September 1983:
Additional samples of the French isolates are sent to LTCB. One of these is LAV/LAI, IP's prototype HIV isolate. A transfer agreement is included restricting commercialized applications of the French viruses.

November 1983:
According to LTCB scientists, Mikulas Popovic starts his pool experiment from which the LTCB HIV isolate, HTLV-IIIb, is generated.

December 1983:
IP scientists file for a U.S. patent for their LAV antibody blood test. According to the Dingell subcommittee report, between December and May, the application is assigned to three patent examiners, none of whom enters it into PTO's central records system.

January 1984:
LTCB contractor M. Sarngadharan creates a virus antibody blood test.

March 1984:
Gallo and associates submit four papers to Science describing discovery of the virus and development of a blood test.

April 1984:
The Department of Health and Human Services (HHS) holds a press conference to announce the discovery of the virus and development of the blood test. The same day, Gallo and associates submit patent applications for the blood test and for the method of growing the virus.

May 1984:
Four papers written by LTCB scientists are published in Science (M. Popovic et al., 224:497-500; J. Schupback et al., 224:503-5; R.C. Gallo et al., 224:505-6; M.G. Sarngadharan et al., 224:506-8).

May 1985:
Gallo and his associates are awarded a U.S. patent on the HIV antibody blood test. The French application is still pending.

August 1985:
French officials register a complaint with HHS, charging that HTLV-IIIb is LAV. They ask for equal share of credit and royalties. National Cancer Institute associate director Peter Fischinger investigates and rejects the French claims.

November-December 1985:
Negotiations between HHS and IP attorneys break down. The French file suit in U.S. Court of Claims charging breach of contract.

April 1986:
The U.S. Patent and Trademark Office declares an "interference" between the LTCB and IP applications, a process for judging the merits of competing claims.

March 1987:
President Ronald Reagan and French Prime Minister Jacques Chirac agree on a settlement to end the patent dispute and divide the royalties. As a result of sales, the U.S. earns more money under the agreement.

April 1987:
HIV geneticist Gerald Myers writes a memo to senior officials calling Gallo's statements that LAV and HTLV-IIIB are genetically independent and that HTLV-IIIb originated from a virus pool a "double fraud."

November 1989:
The Chicago Tribune publishes John Crewdson's 50,000-word article on the discovery of HIV ("The Great AIDS Quest," Nov. 19, 1989), provoking new concerns about fraud and misconduct.

December 1989:
Rep. John Dingell (D-Mich.), writes to NIH to inquire how it plans to investigate the charges made in Crewdson's article.

October 1990:
NIH's Office of Scientific Integrity (OSI) begins a formal investigation of Gallo and Popovic regarding possible misconduct associated with a May 1984 Science paper.

June 1991:
An OSI draft report finds Popovic guilty of scientific misconduct and states that Gallo's actions "warrant significant censure."

October 1991:
The U.S. Attorney for the District of Columbia declines prosecution, citing insufficient evidence and complexity of the issues, and stating that alleged falsifications in the May 1984 paper are immaterial.

January 1992:
A National Academy of Sciences-nominated panel chaired by Yale University biochemist Frederic Richards issues a report critical of Gallo. Its recommendations are not incorporated into the OSI report. The Dingell subcommittee on oversight and investigations begins its probe by serving NIH with a document request.

March/April 1992:
The OSI final report is released with fewer charges against Popovic. The call for censure of Gallo is withdrawn.

June 1992:
HHS commissions a Chicago law firm, Allegretti and Witcoff, to review the U.S. and French patent claims. The lawyers conclude that there is no evidence of falsification in the LTCB patent application and no intent by Gallo to act inequitably.

December 1992:
The Office of Research Integrity (ORI) completes its review of the OSI report. ORI finds Gallo guilty of misconduct and reaffirms OSI's charges against Popovic.

August 1993:
ORI issues a 99-page "Offer of Proof," listing numerous scientists willing to testify against Gallo.

November 1993:
The Departmental Appeals Board exonerates Popovic of misconduct. Subsequently, ORI withdraws all charges against Gallo.

January 1994:
The United States Attorney for the District of Maryland in Baltimore declines to prosecute Gallo and Popovic for allegedly making false statements on the patent application, citing statute of limitations and jurisdictional problems, among other concerns.

June 1994:
The HHS Inspector General issues a 35-page closing memorandum on the Gallo case, documenting evidence against the LTCB scientist.

July 1994:
NIH, now under director Harold Varmus, renegotiates the blood test royalty split with the French. The new agreement guarantees that the French will receive 50 percent of the royalties. Gallo will continue to receive $100,000 a year.

December 1994:
The Dingell subcommittee report is leaked to the press just before the transition from Democratic to Republican control in the Congress. An article in the Chicago Tribune appears on Jan. 1, 1995 (J. Crewdson, section 1, page 1).

February 1995:
Dingell writes a letter to Varmus saying he "cannot vouch for the authenticity" of the document bearing his subcommittee's name.
Healy, who had been appointed to the NIH directorship by Republican President George Bush, clashed numerous times with the Dingell subcommittee over the Gallo investigation and other matters. She calls the report "a pathetic parting shot" from the subcommittee staff. "You had too many years of Democratic control," she comments. "Those chairmen felt they were above the law."

Concerning the role of current NIH director Harold Varmus, the report says that ". . . although the HHS Office of Inspector General (OIG), the United States Attorney, and the Subcommittee had by this time amassed a substantial body of evidence demonstrating probable misconduct, Varmus . . . refused to forward that evidence to a Surgeon General's Board of Inquiry...."

Varmus, through NIH spokespersons, declines to comment on the report.

The subcommittee assessed evidence that, the report states, had not been made known to OSI or OIG investigators: a 1987 analysis of genetic sequences from various isolates by Gerald Myers, director of the HIV Sequence Data Base and Analysis Project at Los Alamos National Laboratory. Documents from Myers refer to Gallo's statements that his virus came from a pool of patients and was genetically independent from the French as a "double fraud." The report states that the subcommittee did not obtain the Myers documents until last year, and they were not available for consideration in earlier investigations.

Yale's Richards says that he lost all hope that the investigation would be reopened when NIH administrators did nothing after the Myers documents were found in 1994. Now he is frustrated that the subcommittee report was merely leaked: "It was my understanding that this document was in its present form early last summer. The question is, why wasn't it released?"

The subcommittee document also mentions other evidence that, according to its authors, was either never provided by Gallo and HHS and NCI officials (including attorneys' notes from the Department of Justice and "primary data from LTCB experiments comparing the IP and LTCB prototype isolates") or withheld for as long as two years.

Gallo refers to the report as "a lunatic obsession" on the part of the subcommittee. Martin Delaney, founding director of Project Inform, a San Francisco-based AIDS advocacy group, agrees: "I think an injustice was done here against the legal system and against the rights of scientists. This is a statement about abuse of power in the Congress."

Hadley, a former chief investigator for OSI who continued to delve into the case on assignment to the Dingell subcommittee, counters: "Bob [Gallo] seems not to understand that the report is a consensus staff report. . . . We've laid it out there; the evidence is there." She adds that the document breaks new ground: "The cover-up part of it has never been reported by an independent investigative body."

As evidence for his assertion that the findings of the report should not be believed, Gallo cites a February 3 letter from Dingell to Varmus saying, "we cannot vouch for the authenticity or accuracy of the papers provided to you. . . . While some staff time was spent developing a report, one early draft on the matter had been rejected by the Subcommittee staff director several months ago."

"This is not an official report," says Gallo, "and Dingell has disavowed it." He emphasizes, "Every point [of evidence] that's in that story has been said before; they have not been able to prove wrongdoing."

Hadley denies that an early draft of the report had been rejected. But she acknowledges that a first effort at summarizing the investigation was aborted when the text grew to more than 1,000 pages.

She wrote a personal letter to Dingell in which "I confirmed for him the authenticity and accuracy of the report."

Dingell responded in a March 9 letter to Hadley stating that he "had confidence in the staff's work" on the report but "wasn't happy that the draft wasn't reviewed by the staff director, and that it got out to the media," she says.

Stewart believes the full effect of the document's distribution will take time: "These things don't happen overnight."

Hadley concurs: "I did not expect an immediate groundswell from this."


LONGTIME CRITIC: Former CDC scientist Don Francis praises the "extensively researched" report.
But other sharp critics of Gallo speculate that the scientific community will continue to be apathetic. "I think everybody has lost interest in this," comments Francis, now a clinical scientist at Genentech Inc. of South San Francisco, Calif.

"It's now at the stage where it's really at the hands of the historians," comments Yale's Richards. "The general interest has faded. Everyone is basically sick of this and has already made up their minds."

Los Alamos' Myers, when asked if he will read the subcommittee report, replies, "I'm really not interested. I've got so many more things to do that I feel are more important. I'm sure that everybody just wants to go on."

The report, in addition to being put online, was disseminated further by Serge Lang, a professor of mathematics at Yale University. Lang has long been circulating copies of Gallo investigation reports and related documents to scientific community leaders and news organizations, including The Scientist.

"The availability of the Subcommittee Staff Report provides one more opportunity to learn or acknowledge the facts, and to speak out," Lang wrote in a cover letter accompanying the report.

In a letter thanking Lang for sending the document, Harvard Medical School professor Kenneth Ryan, head of a Commission on Research Integrity that is looking into how NIH handles misconduct cases, wrote: "I will have it reproduced for all our Commission members. It obviously should inform our work and help in our deliberations."

Speaking to The Scientist, Ryan is more guarded: "It's difficult to evaluate a report such as this, which relies on facts, when you don't have all the supporting material. If the material is true, it's a shattering indictment."

Of his commission's consideration of the report, Ryan says, "The relevance of the Dingell report now is what it can tell us about the kinds of recommendations we should make."

Harvard's Schaffer, a member of the Ryan commission, thinks that, "with regard to the manner in which this case was handled, it was suboptimal."

Former NIH director Healy denies a statement in the report's executive summary that "In mid-1991, early in her tenure as NIH Director, Dr. Bernadine Healy told Chairman Dingell, concerning Dr. Gallo, that she felt she had to 'save Bob.'"

"That is a total fabrication," Healy says. "This is vintage Dingell . . . they will take a phrase and intentionally distort it . . . . That committee abused people."

In answer to Healy's charge, Hadley says: "I stand behind the truthfulness and accuracy of the report."

Gallo's attorney, Joseph Onek, in a written response to the subcommittee document, asserted that the subcommittee "wasted hundreds of thousands of taxpayer's dollars."

A spokesman for Dingell says that the subcommittee had run on an annual budget of $750,000 but that no separate accounting was available to show what percentage of that budget funded this investigation.

According to a spokesman for Rep. Thomas Bliley (R-Va.), Republican congressional leaders have no plans to release this document officially or to reopen the investigation. Likewise, OIG and ORI spokespersons say that their offices are not planning to reopen their investigations.

"The truth is, there should never have been an investigation," declares Gallo. He adds: "They want a head on a platter. They spent a lot of time and a lot of money. If there is something to the story, my head would have been off long ago."

Paul Kefalides is a freelance writer based in Philadelphia.