Duesberg on AIDS- The Gallo Case- Part 5

The Dingell Subcommittee experienced considerable difficulties in obtaining information from NIH. These difficulties were mentioned by Dingell himself as quoted in the preceding section, and I learned of them via the usual sources of information, Greenberg's Science and Government Report, or Crewdson's articles in the Chicago Tribune, but not from Science or the New York Times, to mention only two of the mainstream press. I quote from the informative sources.

(a) According to Greenberg's Science and Government Report of 1 December 1992, Dingell accused NIH Director Healy of hampering the Gallo probe as follows:

(b) In his Chicago Tribune article of 6 December 1992, concluding a section entitled "Political Science," Crewdson wrote:

(c) We have seen in XVI, §2, how Dingell's staff finally extracted the Myers documents from the files of NIH in December 1993, after these documents were withheld from Dingell over the years,

As of January 1995, the Dingell Subcommittee on Oversight and Investigation was no more, because of the Republican majority victory in November 1994. However, the Subcommittee staff had prepared a report which is mostly due to the work of Suzanne Hadley, and which became available during January 1995. This report is 267 pages long. It is accompanied by an Executive Summary, 65 pages long.

Some scientists had written to Dingell in 1994 to urge the Subcommittee to issue the report on the Gallo case.¹ It is unfortunate that the political circumstances have prevented this report from being available from the Government Printing Office, especially since there were Republicans on the Subcommittee, which on this issue appeared bipartisan. Individual scientists and the media now have the responsibility for the distribution of the Subcommittee Staff Report, which contains extensive documentation. Much of this documentation has not been publicly available before, partly because NIH covered it up. The full text can be accessed via the World Wide Web at the following URL:

http://nyxl0.cs.du.edu:8001/~wstewart/

Footnotes for page 557¹ For example:
- 23 January 1994, from Elliott Lieb to Dingell: "I am writing to urge, in the strongest possible terms, that your committee issue a full report on the Gallo case. It is clear that this case and its importance did not die with the Appeals Board ruling. It is also clear that the public, and especially the scientific community needs to know everything that your committee found despite the obstructions laced in your way. We need this information if we are to maintain high ethical levels in science and in the administration of science." (Elliott Lieb is Jones Professor of Mathematical Physics at Princeton, and is a Member of the NAS.)
- 4 February 1994, from John Edsall to Dingell: *As a biochemist who is deeply concerned with maintenance of standards of integrity in scientific work, I have followed the controversy over the discovery and identification of the virus of AIDS, with particular reference to the role of Dr. Robert Gallo... I believe that the standards of ethical conduct for scientists are, and should be, more demanding than the purely legal rules. They must be so, if the public is to retain its confidence in the scientific community. In fact, looking at the history of the Gallo investigation, I see a pattern of evasion, and suppression of information, at several points along the line .... It appears, however, that the attempt to clear Dr. Gallo of all legal charges against him is on the verge of complete success. If you have strong evidence that could lead to a different conclusion, would not this be the time to make it public, in the interest truth and honesty...? (John Edsall is Professor of Biochemistry Emeritus at Harvard, and is a member of the NAS.)
- 7 February 1994, from Charles Park to Dingell: "You are to be congratulated for your continued pursuit of the truth in the Gallo case. What you have done and hopefully continue to do is very important arid is much appreciated by the scientific community. I understand that your Subcommittee on Oversight and Investigation has collected information on the Gallo case that has not previously been made public. I hope the Committee will make a full disclosure of this material." (Charles Park (M.D.) is Professor Emeritus of Physiology, and is a member of the NAS.)

pg 558

It remains for individuals, and especially scientists, to speak out and act. I personally distributed copies of the Staff Report to a cc list of over 100 persons throughout the United States, and in addition, I sent a copy for duplication and distribution to the Council of the National Academy of Sciences.

One member of the Academy, from whom I had never heard previously, wrote me on 26 January 1995 concerning the Staff Report:

The letter was signed by William A. Hagins, Laboratory of Chemical Physics, National Institute of Diabetes and Digestive and Kidney Diseases.

The Subcommittee Staff Report confirmed the findings of the Inspector General's Memorandum and the ORI Offer of Proof, as far as they went.

The availability of the Subcommittee Staff Report shows once more the extent to which the main scientific press and the mainstream press have not provided proper, documented information to the scientific community and to the public at large, Greenberg and Crewdson excepted. On the other hand, it provides one more opportunity to learn or acknowledge the facts, and to speak out. I shall quote extensively from the Staff Report. I begin with extensive quotes from the introduction to the Executive Summary.

Staff Report
Subcommittee on Oversight and Investigation
Committee on Energy and Commerce
U.S. House of Representatives

Encouraged by prominent scientists, the Subcommittee on Oversight and Investigations in 1987 began a review of the institutional response to cases of alleged or suspected scientific misconduct by scientists involved in federally supported research. At that time, the problem was readily discernible. When situations of possible scientific misconduct arose, the institution's response generally was to walk the whistle-blower out the door, sweep the problems under the rug, and to protect, at all costs, the reputations of the senior scientists. As one scientist explained, "It was as if they had their own fiefdoms whereby they set their own rules."

In April 1988, the Subcommittee held what it expected to be its first and only hearing on the problems associated with how the

institutions were responding to instances of scientific misconduct. What the Subcommittee did not recognize at the time was that rather than pointing out a problem that the community would rally around in an effort to correct, it was, in fact, exposing a not very well-kept secret that the scientific community was not prepared to deal with.

To those who were attempting to expose these problems, the hearing was a breath of fresh air. In the 24 hours after that first public hearing, the Subcommittee received reports of no fewer than 18 new cases of alleged scientific fraud. To those who wanted to maintain the status quo, the Subcommittee became a threat; numerous attempts were made to thwart the Subcommittee's efforts and limit Congressional oversight of Federally funded scientific research.

Given the debate, the Subcommittee felt it was important to go into the issue in further detail, and much as it did with defense contractors, generic drug manufacturers, and the nuclear power industry, the Subcommittee decided to select a case study to determine, in detail, how institutions respond to allegations of scientific misconduct and whether the system, in fact, works.

The case study selected for review was the so-called "Baltimore" case. The primary reasons the Subcommittee focused on this case were that (a) two institutions had already had--and botched--an opportunity to properly investigate the matter and (b) the whistle-blower had been effectively driven out of science for her efforts in bringing the facts to light. The further the Subcommittee pursued the case, the more the community rallied around the defense ....

Even as the Subcommittee began to see some progress at research institutions, it was evident that effort had been geared toward research institutions outside the Federal government. At the time, over a billion dollars was being spent at the National Institutes of Health (NIH) on intramural research. Consequently, it was important to determine if the same unwillingness to deal effectively with cases of potential misconduct observed in non-Federal institutions also existed within the Federal government's own research community. As a result, the staff was directed to conduct a case study involving allegations of misconduct in an intramural research program.

At this time, the Subcommittee was investigating the Laboratory of Tumor Cell Biology (LTCB) within the National Cancer Institute (NCI} at NIH, due to allegations of kickbacks and diversion of

Federal funds by two prominent scientists within that laboratory. Ultimately, both investigations resulted in felony convictions. As a result, in 1989, when allegations of scientific misconduct resurfaced against the chief of that laboratory, allegations which had first been raised in 1985-86, the Subcommittee was in a good position to use the LTCB as its intramural case study.

In contrast to the situation at extramural research institutions, there has been little or no progress at the Department of Health and Human Services (HHS) or NIH in their response to cases of possible scientific misconduct in the intramural laboratories. In fact, the situation at HHS/NIH resembles the situation at extramural institutions more than ten years ago ....

The only real attempt at NIH to vigorously examine the facts of this case occurred when Dr. William Raub was the Acting Director of NIH. Dr. Raub insisted on the appointment of an independent panel, nominated by the National Academy of Sciences (NAS), to review HIH's handling of the case, to ensure an adequate response.

Initially, the NIH assigned its new Office of Scientific Integrity (OSI), assisted by an outside panel of experts, to conduct a formal inquiry and investigation. While this beginning was very positive, it shortly unraveled. In 1991, a new NIH Director was selected: Dr. Bernadine Healy. By the time of her appointment, the OSI investigation had been completed and a draft report had been prepared .... Concerning Dr. Gallo, the entire panel and OSI severely criticized Dr. Gallo and they strongly questioned his fitness to continue to serve as a laboratory chief at NIH. But then, through a series of events described later in this report, Dr. Healy effectively demolished OSI, greatly limited the supposedly independent review of the NAS Committee, and eventually attempted an end-run of its findings. In short, Dr. Healy did everything she could to protect her superstar, senior scientist.

In 1993, the NIH directorship changed again with the selection of Dr. Harold Varmus as Director of the NIH. The atmosphere of overt protectionism of Dr. Gallo was ended. However, 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, Dr. Varmus, who was advised throughout by HHS General Counsel Harriet Rabb, refused to forward that evidence to a Surgeon General's Board of Inquiry, the duly authorized disciplinary body for the members of the HHS Commissioned Corps. Dr. Gallo is a Captain in the Corps.

In addition, despite strenuous pressure from attorneys and top officials of the Institut Pasteur (IP),

Dr. Varmus refused to even consider a possible reallocation of royalties from the HIV blood test patent until he was confronted with a serious threat of an imminent lawsuit. Even when he finally agreed to a reallocation of the royalties, Dr. Varmus (with HHS' blessing) merely negotiated an increase in the IP share of the royalties, based on a disingenuous explanation of accounting anomalies, rather than the proven fact that the LTCB scientists, contravening a formal transfer agreement, used an IP AIDS virus isolate to make their blood test.

The IP virus received at the LTCB in September 1983 was accompanied by a transfer agreement that stipulated the virus would "... not be used for any industrial purpose without the prior written consent of the director of the Pasteur Institute."

The transfer agreement further bound the recipient, "... not to disseminate the virus in any form (to companies or other scientists) without the prior written authorization of the Director of the Pasteur Institute."

Dr. Mikulas Popovic, a top LTCB scientist, signed the transfer agreement on September 23, 1983, affirming, in addition to the above, that the IP virus, "... will be used by the recipient himself, exclusively, and only for the following research purposes...: (a) biological; (b) immunological and (c) nucleic acid studies."

The popular view of the so-called "Gallo case" is that it is about whether Gallo et al. "stole" or misappropriated the IP virus. While this is indeed the central, original issue relative to the LTCB scientists, the case as it bears on the institutional response subsumes other vital issues, including how political and international reputational imperatives at HHS assumed preeminence over scientific integrity, and how defending the claims of the LTCB scientists came to be perceived as tantamount to defending the United States Government itself.

Major issues relating to the institutional response include the following: (1) the validity of HHS' claims to the United States Patent and Trademark Office (PTO), in applying for a patent on the LTCB HIV antibody blood test; (2) the integrity of HHS' response to the IP challenge in the mid 1980s, including the tacts and substance of legal briefs filed on behalf of Gallo et al; and (3) the integrity of HHS current response to the mounting body of evidence

calling into question the actions and statements of both NCI scientists and HHS officials/attorneys.

1. Did Gallo et al. Misappropriate the IP Virus? [The Executive Summary then goes into some concrete evidence, partly confirming the evidence already mentioned coming from the Offer of Proof and the HHS IG Memorandum, and partly some evidence which I had not been aware of.]

2. The Institutional Response: The manner and content of HHS' response to the challenge to Gallo et al. was set as early as April 23, 1984, the day of the HI-IS press conference. Although a few crumbs were thrown to the IP scientists, the glory was all for Gallo et al. and the United States Government. Numerous unsubstantiable claims were made at the press conference by "our eminent Dr. Gallo," as HHS Secretary Margaret Heckler repeatedly described him. Secretary Heckler also elaborated at some length how the LTCB scientists' "discoveries" proved the administration's commitment to AIDS/HIV research.

Just minutes before the press conference, HHS submitted applications for U.S. patents on an HIV antibody blood test and a method of producing the virus. These patent applications contained the seeds of the French/American dispute; they contained fundamental assertions that could not be substantiated. Chief among these was the assertion that

The real inventors of the HIV blood test were the IP scientists, who had developed and begun to use their blood test the previous Summer (1983) ....

Dr. Gallo and his colleagues did not disclose to PTO their knowledge and use of the IP blood test, nor did they disclose the IP scientists' considerable body of scientific work on their virus and blood test ....

The HHS response to the IP challenge, which at this time was informal, was immediate and reflexive. The response was to de-fend--at all costs and irrespective of the evidence--the claims of Gallo et al. The Subcommittee investigation showed that HHS officials and attorneys 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. HHS officials accepted

uncritically everything they were told by Dr. Gallo and his colleagues, incorporating the LTCB scientists' information unqualifiedly and without confirmation into official reports of the Department. When these officials encountered hard evidence that contradicted the NCI/HHS claims, the evidence was ignored, discarded, and/or suppressed.

DOJ attorneys, in turn, took the "facts" they were given by NCI/HHS and incorporated them, often nearly verbatim, into U.S. Government pleadings in the Claims Court and before the PTO. At the same time, HHS and DOJ sought by every means at theft disposal to thwart IP's discovery of evidence that would reveal the truth about the LTCB claims. According to attorney's notes and participants' accounts, despite top HHS officials' awareness that many of the claims of Gallo et al. were, at best, highly questionable and without substantiation, HHS determined to "play out" the U.S. defense as long as possible, and "roll over" only when defeat became inevitable.

The HHS agency-level cover-up started early. In August 1985, HHS charged NCI to "investigate" the claims of Gallo et al. The investigation was conducted by a single individual--Dr. Peter Fischinger--one of Dr. Gallo's superiors who even before he started his inquiry, pronounced the LTCB claims solid and entirely valid. Dr. Fischinger's investigation resulted in the so-called "Fischinger Report," which became the central substantive document on which the HHS/DOJ attorneys relied, in their defense of Gallo et al.

The manner in which Dr. Fischinger went about his task makes clear how perverse was the entire effort, and how distorted an account the Fischinger report provided regarding the so-called facts of the case. At the outset, Dr. Fischinger posed a series of questions to Dr. Gallo, questions that focused on demonstrably irrelevant non-issues, most notably the alleged "other isolates" of Gallo et al. Based solely on the responses of Gallo et al., Dr. Fischinger hurriedly wrote his report, which the Subcommittee investigation found to contain numerous incorrect, misleading claims (see below). Dr. Fischinger took the remarkable step of requiring Dr. Gallo to certify in writing that all the information contained in the report was correct and supported by data.

Only after completing his report did Dr. Fischinger write a super-confidential memorandum to Dr. Gallo, in which he (Fischinger) required Gallo to address "three major areas of oversight," one of which concerned the central issue in the entire dispute, i.e., the question of possible misappropriation of the IP virus. Regarding this issue, Dr. Fischinger asked for a

Dr. Popovic's response to Dr. Fischinger's request concerning this major area of oversight was a nonresponse, a transparent evasion of Dr. Fischinger's request (see below, p. 47). Even Dr. Fischinger should have recognized something was being withheld from him, something was amiss. But Dr. Fischinger, so far as is known, did nothing. He permitted his report to stand, a report containing the blanket assertion that,

Based on the LTCB evasions and misrepresentations, HHS rejected IP's informal challenge. The matter soon thereafter moved into formal legal proceedings.

Yet at the very moment HHS was dispatching a September 6, 1985 rejection of the IP demands, HHS officials were confronted with damning new evidence that strongly challenged the claims of Gallo et al. On September 5, HHS officials traveled to the NIH where they were told by laboratory chief Dr. Malcolm Martin about experiments performed in his laboratory that showed the IP and LTCB viruses were generically identical, with the LTCB virus descended from the IP virus, and not the reverse. The following day, the same HHS officials traveled to the HHS Centers for Disease Control (CDC) where they learned that the IP scientists discovered HIV and made a blood test fully the equal of the LTCB test, long before Gallo et al. But these dramatic revelations did not in any respect alter HHS' course. In fact, HHS' only action was to ask Dr. Gallo to provide a further response. Meanwhile, HHS officials "deep-sixed" the extensive documentation they had been given to substantiate the Martin and CDC conclusions (see below, p. 47). Some of this evidence was withheld from the Subcommittee until late 1993.

With their claims rejected, in the Fall of 1985, the IP attorneys filed a request at PTO for an "interference" with the Gallo et al. blood test patent (an interference is USPTO procedure for determining priority of invention between two or more parties claiming the same patentable invention). In addition, in December of 1985, the IP attorney's filed a suit for breach of contract in the U,S. Court of Claims. The trust of the interference request was that

the IP scientists should have been awarded the U.S. patent on the HIV antibody blood test, because they both isolated the virus and invented the blood test long before Gallo et al. and because their patent application clearly predated that of Gallo et al ....

The legal pleadings submitted by attorneys defending Gallo et al. were packed with false and misleading claims, hardly surprising, given their exclusive reliance on information provided by the LTCB/NCI. The attorneys argued, in the strongest terms, that the IP and LTCB blood test viruses were distinctly, genetically different, e.g.,

... Concerning the inventorship of the HIV antibody blood test, HHS/DOJ attempted to argue that the Gallo et al. test was a different invention from that of the IP scientists ....

In addition, concerning the failures of candor and the duty of disclosure, the HHS/DOJ attorneys argued this:

The Subcommittee investigation showed that the HHS/DOJ legal arguments could not be substantiated. The HHS attorneys themselves recognized that they were on very thin ice. In closed door discussion with their counterparts at DOJ, the HHS attorneys described their principal arguments as a "weak thread to rely on" and "a two-edged sword."

The already-fragile HHS/DOJ arguments were further jeopardized in the Spring and Summer of 1986, first with the public revelation of electron micrographs of the IP virus, published by Gallo et al. as "HTLV-III," showing the virus productively growing in permanent cell lines. (This, of course, was the virus that Dr. Gallo had previously and repeatedly asserted did not grow.) Then, during the Summer of 1986, PTO--having finally comprehended how badly it had been misled--began to invoke the IP work as prior art to Gallo et al, threatening to throw numerous pending Gallo et al. applications into the ongoing blood test patent interference. The documented content of an "off the record" conversation between the PTO examiner and an attorney for Gallo et al.

Impelled by these developments, in the Fall of 1986, HHS increased its efforts to obtain a settlement of the French/American dispute. A settlement was signed, in March 1987, but the settlement barely managed to paper over the glaring unresolved issues, and it began to unravel almost before the ink on the settlement was dry.

HHS did its best to cover up the wrong-doing. Meanwhile, the failure of the entire scientific establishment to take any meaningful action left the disposition of scientific truth to bureaucrats and lawyers, with neither the expertise nor the will essential to the task. Because of the continuing HHS cover-up, it was not until the Subcommittee investigation that the true facts were known, and the breadth and depth of the cover-up was revealed. This report describes the facts, and how and why HHS went so badly wrong. [Emphasis added]

The challenges to the Subcommittee's investigation, and to the OSI and OIG investigations as well, were significant .... Documentary evidence was vital to the investigation; however, systematic withholding of documents was evident from the outset, on the part of both agencies and individuals. Key documents frequently were withheld for prolonged periods, in many cases, for years. Some critical documents known to exist were never officially produced. Among the most noteworthy such instances were the following:

The Myers documents also showed that in early 1989, faced with the evidence, Dr. Gallo was about to "throw in the towel" and admit publicly that the LTCB and IP prototype viruses are genetically identical, with the LTCB virus derived from the IP virus; At the last minute, Dr. Gallo reneged on his commitment to make a public acknowledgment of the viruses' identity, and a year later,

when the OSI inquiry was underway, he asserted repeatedly that the viruses could be genetically independent, and even if they were identical, the "contamination" could have occurred at the IP, rather than at the LTCB ....

Testimony posed at least as great a challenge as documentary evidence, party because memories of some witnesses had eroded, due to the passage of time. At least as serious was the problem of willful forgetfulness and obstructionism, of which the following instances are exemplary:

The April 23, 1984 Filing of a United States patent application for the HIV antibody blood test of Gallo et al. was a defining event for HHS as well as the LTCB scientists. The commercialization of the IP virus in and of itself would violate the terms of the IP transfer agreement that accompanied the virus sample (see p. 24 for further details); the patent application further "upped the ante" dramatically for all concerned ....

On April 23, 1984, when Dr. Gallo and his associate submitted applications for United States patents on their HIV blood test and a method for virus production, they affirmed, under penalty of criminal prosecution for making false statements, that they were,

... The attorneys who prepared the April 1984 patent applications for Gallo et al. told Subcommittee staff that they instructed Gallo et al. about their duty of disclosure. Yet according to these attorneys, even they were not told by Gallo et al. about the IP prior art, nor were they told about the LTCB scientists' own work with the IP virus. Both the attorney's and the PTO examiner told Subcommittee staff that numerous aspects of the IP and LTCB work were material to the claims of Gallo et al. and should have been disclosed ....

1. Knowledge of and Benefit from the IP Scientists' Work With Their Virus: The IP scientists were first to publish on the AIDS virus (Barre-Sinoussi et al., Science, May 1983) ....

Gallo et al. did not disclose any of the IP publications to PTO, save for a single, misleading reference in one LTCB paper cited in one of the Gallo et al. patent applications, a reference that implied the LTCB and IP viruses were different. Neither did Gallo et al. disclose any of the IP scientists' papers, presented at meetings which Gallo and his colleagues attended. Consequently, the PTO examiner had to discover them on her own. The IP publications unquestionably were material to the Gallo et al. applications. In fact, when she belatedly became aware of the IP publications, the PTO examiner declared that both Barre-Sinoussi et al. and Montagnier et al. were "prior art" to the blood test CIPs of Gallo et al. For this reason, she repeatedly rejected every claim contained in these CIPs.

The PTO examiner cited both sections 102[a] and 103 of 35 U.S.C. as the basis for her rulings. Concerning claims in the Gallo et al. blood test CIP applications, the examiner said the claims:

The PTO examiner's realization of the significance of the IP scientists' work came only after the Gallo et al. blood test patent had already been issued, too late for the IP work to be cited against that patent. By August 1986, once an "interference" had been declared between the Gallo patent and the IP blood test patent application, PTO was preparing to either suspend all the pending Gallo et al. CIPs or incorporate them into the interference. Either eventuality would have been significantly damaging to both HHS' patent program and HHS' position in the French/American dispute.

In May 1985, the USPTO awarded a patent on the HIV antibody blood test to Dr. Gallo and his colleagues. The Gallo et al. patent was issued in record time, just thirteen months and one Office Action after it was submitted. At the time the Gallo et al. patent issued, the IP patent application, submitted over four months prior to the submission of the Gallo et al. patent application, had not been touched .... The differential handling of two applications for the same invention has never been satisfactorily explained, the consequences in disadvantaging the IP application are clear.

The IP application was passed among four different examiners; consequently, the application had never been "briefed," i.e., there was no PTO record of the IP claims. When the PTO examiner of the Gallo et al. application conducted an "interference search" just prior to issuing Gallo et al., she found no record of competing claims. According to the examiner, when she first saw the IP application, within two weeks of issuing Gallo et al., she recognized immediately that PTO had "screwed up" in issuing the Gallo et al. patent. The examiner told Subcommittee staff she recognized that the Gallo and Montagnier inventions were "directly related." The examiner also said that had she become aware of the IP application during her examination of Gallo et al., she would have suspended examination of Gallo et al. and "... would have thrown them into an interference."

But by the time the examiner saw the Montagnier et al. application, the Gallo et al. patent had already been issued. Consequently the burden of seeking an interference fell on the true inventors of the HIV antibody blood test, Montagnier et al.

[The Staff Report and the Executive Summary go on with meticulously documented statements about the history of the Gallo case. The above constitutes a sample of the ongoing text. I now jump to the concluding paragraphs, pp. 64-65.]

One of the most remarkable and regrettable aspects of the institutional response to the defense of Gallo et al. is how readily public service and science apparently were subverted into defending the indefensible.

To comprehend the significance of the subversion of public service in the cover-up, it is useful to review the Guidelines of the Ethics Committee of the Washington D.C. Bar Association concerning the roles of government attorney's. According to the guidelines,

These guidelines, although they focus on government attorney's, apply at least as well to the NCI/HHS science administrators who played such a crucial, "make-or-brake" role at the outset of the French/American dispute. The deliberately negligent "fact-finding" conducted by these individuals, combined with their deliberate suppression of incriminating evidence, set the stage for everything that happened thereafter. But the attorneys bear significant responsibility as well, for they clearly did not seek diligently to "develop a full and fair record" of the facts about the claims of Gallo et al.

Neither did HHS/DOJ officials and attorney's, once the dispute was under way, deal responsibly with the accumulating evidence that there were serious problems in the U.S. Government's claims. Instead, they pushed on with their "litigation strategy," all the while adding deception to deception, consuming untold resources and squandering scientific and international good will. The fraud became self-perpetuating. Defending the indefensible became a reflex, until ultimately, the cover-up was so burdened with falsehoods that its collapse was inevitable. HHS officials and attorneys should have recognized early on that the falsehoods could not be indefinitely sustained. But HHS sought only to "defend the position." HHS did not see the truth. HHS did not honor the public trust.

The violence to principles of responsible, ethical science was just as profound. At a crucial point early in the LTCB's HIV research, international politics and the technocrats committed to those politics virtually took over that research, claiming the laboratory's putative accomplishments as accomplishments of the United States administration and by extension, the United States itself.

Once done, the LTCB's interests became the Government's interests; defending the LTCB scientists' reputations and claimed accomplishments became necessary for defending the honor of the United States. The defense thus became a consuming effort for significant portions of the U.S. Government.

The result was a costly, prolonged defense of the indefensible in which the LTCB's "science" became an integral element of the U.S. Government's public relations/advocacy efforts. The consequences for HIV research were severely damaging, leading, in part, to a corpus of scientific papers polluted with systematic exaggerations and outright falsehoods of unprecedented proportions.

To comprehend how far from the ideal the defense of Gallo et al. led the scientific community, it is useful to note the words of two esteemed scientists, Drs. John Cairns and Paul Doty:

There could be no better description of the disastrous consequences of the U.S. Government's defense of Gallo et al.

[I shall next reproduce extracts from the documentation itself, that is quotes from the main participant, Gallo, and some other people. These excerpts from the Executive Summary and Staff Report reflect some of the more notable of the numerous unsubstantiable or false claims, denials, and shifting stories relating to major issues considered by the Subcommittee's investigation. These excerpts

document meticulously how U.S. Government officials and attorneys adopted and promulgated, on behalf of the United States Government, unsubstantiable or false claims concerning certain putative accomplishments of Dr. Robert Gallo and his associates at the National Cancer Institute (NCI) Laboratory of Tumor Cell Biology (LTCB). S.L.]

EXTRACTS FROM THE STAFF REPORT
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
January 1995
Selection by Serge Lang

[Such claims were a central element of the U.S. Government's defense of the blood test patent of Gallo et al., because scientists at France's Institut Pasteur (IP) developed and applied for a patent on the HIV blood test months before Gallo et al did so. The Staff Report documents, with quotes from the principals, that the claims of 1982 HIV isolates "were not true" (Executive Summary, p. 9). I reproduce some of these quotes.]

Gallo et al. in AIDS: Etiology, Diagnosis, Treatment and Prevention, 1985, p. 34: 'The first HTLV-III [Gallo's name for HIV] isolates were obtained in this laboratory in November 1982, and HTLV-III was subsequently isolated from approximately 100 patients with AIDS or from healthy individuals at risk for AIDS." (Staff Report, p. 11)

Salahuddin, Gallo, et al., PNAS 82, 1985 pp. 5530-34: "Since the fall of 1982, independent isolates of HTLV-III have been obtained in this laboratory ... from 101 AIDS and ARC patients and healthy donors at risk for AIDS." (Staff Report, p. 12)

Opposition of Gallo et al. to the Motion of Montagnier et al. for Judgment, November 1986, Interference Proceeding of the U.S. Patent and Trademark Office (PTO), p. A8: "In late 1982-early 1983, [Gallo] obtained a number of viral isolates including HTLV-III.("Executive Summary, p, 54)

Preliminary Statement of Gallo et al., PTO Interference, 1986: "The first written description of the invention [the Gallo et al. HIV blood test] was made on December 15, 1982." (Staff Reporters, p. 15.)

Gallo interview, Office of Scientific Integrity [OSI], 16 May 1990, transcript p. 110): "... you are asking me to defend something that I don't--I don't claim we had the cause of AIDS discovered in February 1983 or December 1982 "(Staff Report, p. 18)

Gallo remarks to the Chicago Tribune, published 19 November 1989: "The December '82 data is really marginal .... The data were equivocal. At the time they were not even real data .... The cells died. I can't make any claim for that. Some people would." (Staff Report, p. 19)

Gallo, OSI interview, 25 May 1990, transcript pp. 26-27: 'I never made a claim in the literature for December '82 samples .... We didn't publish these claims in any publication. I am a scientist. I go by what I publish." (Staff Report, p. 20)

Gallo, OSI interview, 16 May 1990, transcript pp. 103-104: [Concerning the PNAS claims cited above] "For all of '82? ... Can I have the reference? I would like to see that in writing if I said that .... I don't believe I would have any reason to say that in PNAS. I mean, it doesn't sound like me." (Staff Report, p. 20)

Gallo in an interview with the Subcommittee Staff, Executive Summary p. 9): "No one believed we really had that many isolates .... No one believed we really meant that .... "

[From the Executive Summary: "The LTCB scientists ... performed all of their seminal experiments ... with the IP virus, first under its own original name .... then under two different names .... " (p. 4) "... the IP virus, under its own name, grew at least two-to-three months at the LTCB" [beginning in the Fall of 1983] (p. 25).]

Gallo to Ian Munro, editor of The Lancet, 6 March 1984: [Referring to the IP virus] "... their virus (viruses) have never been characterized nor transmitted permanently to recipient target cells .... " (emphasis in original) (Staff Report, p. 37)

Popovic, Gallo et al., Science, 225, May 1994, p. 500: [LAV] "... has not yet been transmitted to a permanently growing cell line .... " (Staff Report, p. 37)

Gallo to IP scientist Jean-Claude Chermann, 24 August 1984: "The sample of the virus you sent us the first time had, upon arrival no detectable virus..." (p. 1) and "... we did not grow LAW (p. 3). (Staff Report, p. 38)

Gallo quoted in Science, 230, November 1985, p. 642: [Referring to the IP claim that "Gallo's group somehow grew the French isolate] "Gallo indignantly disputes this allegation on several counts, including the fact that the ... amount of virus Montagnier sent would not have been sufficient to infect a cell line." (Staff Report, p. 38)

Gallo quoted in U.S. News and World Report, 13 January 1986: [Referring to speculation that "Gallo may have mistakenly contaminated his experiments with the French virus"] "That's the height of outrage," responds Gallo, who adds that "it was physically impossible" to grow the particles of virus sent by Montagnier. (Staff Report, p. 39)

Gallo to Dr. Peter Fischinger, Associate Director of NCI, 19 August 1985: [The first virus sample sent from the IP to the LTCB] "did not contain detectable virus." (Staff Report, p. 157)

Opposition by Gallo et al. to the Motion for Judgment of Montagnier et al., PTO interference, November 1986, p. A12: [Concerning the same virus sample] ."..no virus was found in this sample and it appears that virus initially present may have been killed in transit." (Executive Summary, p. 54)

Gallo, OSI interview, 18 July 1990, transcript p. 85: [Concerning the first virus sample sent from the IP to the LTCB, the sample Dr. Gallo told NCI officials in 1985, "did not contain detectable virus "... we knew we had something there and so we saved it." (Staff Report, p. 40)

Gallo, sworn declaration, PTO Interference, November 1986: [Concerning the second virus sample sent from the IP to the LTCB] "Dr. Popovic did succeed in temporarily transmitting LAV to a cell line called HUT-78 and one other T-cell line. However, both transmissions were only temporary in nature" (Executive Summary, p. 54)

Gallo, OSI interview, 8 April 1990, transcript p. 25: [Concerning the second set of virus samples sent from the IP to the LTCB, the samples whose growth Dr. Gallo asserted, in 1986, were "only temporary in nature"] "The growth was significant and continuous." (Staff Report, p. 28)

Gallo, OSI interview, 16 May 1990, transcript p. 87: "... there has been confusion in the response of what we did to LAV. In my response during the passionate period... 'Oh we never grew LAV' and of course we did grow LAV." (Executive Summary, p, 26)

Gallo, OSI interview, 25 May 1990, transcript p. 13: "There is a point where I say I didn't grow LAV. And, of course, LAV was grown .... Quite frankly, it wasn't so germane to me at the time and I was just anguished as to what was coming out of the newspaper. At that moment bombs were going off." (Executive Summary, p. 26)

[From the Staff Report:. "Dr. Gallo's discovery of how to grow the AIDS virus in quantity occurred when Dr. Popovic [one of the LTCB's top HIV researchers] used another scientist's cell line [HUT-78] ... to grow another scientist's virus isolate .... Gallo/Popovic gave the cell line a new name 'HT/H9' ... giving no credit to the true originators, and thereby tacitly as well as explicitly claiming the 'discoveries' as the LTCB's own." (p. 53)]

Gallo remarks at the 5 April 1984 Beecham "Symposium on Infective Agents and Their Effects": "The breakthrough occurred for us when we learned how to transmit this [the AIDS virus] in a particular cell line developed in our lab ... a new line." (Staff Report, pp. 54-55)

Fischinger Report, NCI's official response to the blood test patent dispute, certified by Dr. Gallo as true and supported by data, p. I0: [Referring to the original HUT-78 cell line] "...which is a relative of the HT cell line developed by Dr. Gallo "
(Staff Report, p. 166)

Memorandum from Popovic to Gallo provided to NCI/HHS officials as part of the response to the blood test patent dispute, 6 September 1985: "The detailed characterization of the clone, H9, is being prepared for publication and its comparison with HUT-78 cells ... will soon be performed. In any case, why would anyone care?" [The phrase "why would anyone care?" was added to the memorandum by Gallo himself](Staff Report, p. 57)

Gallo quoted in Science, 248, 1990: "I don't consider it so brilliant. In my mind, there is no credit for a cell line. If it happens by accident you have a cell line, so freaking what (p. 15001 .... The fact is I never really thought it was important. And quite frankly, I still don't and I don't understand the people who do." (p. 1507) (Staff Report, p. 55)

Dr. Albert Sabin, letter to Science, 249, 1990, p. 466: [Referring to the recently published finding that H9 was identical to HUT-78] "This is not a trivial or irrelevant matter, as it was called by Gallo and Popovic, because the use of such uncontaminated, continuous lines of human T4 lymphocytes was crucial to the regular isolation of the new retrovirus from patients with AIDS and to the development of the antibody blood test by which it was possible to establish the etiological association of the virus discovered by Montagnier and his colleagues (Staff Report, p.131)

Richards Panel statement, 19 February 1992: "... the so-called HTLV-III virus was thus established and introduced to the world with no reference to or discussion of two crucial facts ... the cell line utilized [HUT-78] was one that had been obtained from the Minna laboratory .... Although others could have obtained HUT-78 from the ATCC ... the essential identity of HUT-78 with H9 had been effectively obscured." (Staff Report, p. 55)

[Although Gallo made the cell line in which he was growing the virus available to some scientists, he either withheld it from others, or imposed restrictions. According to the Staff Report: "The selective withholding of the H9 cell line and the restrictions placed on its use compounded the harm from the failure of Gallo/Popovic to disclose the true origins of the cell line, i.e. HUT-78, at a time when ready availability of the first published cell line permissive for HIV might have significantly advanced AIDS/HIV research." (p. 131) "... Dr. Gallo went to considerable lengths to prevent scientists whom he knew had obtained the IP virus from using 'his' virus and 'his' cell line...to make their own comparisons" (Executive Summary, p. 43).]

Condition included in the standard materials transfer agreement prepared by the Gallo laboratory in Spring 1984: "Work performed will be on a collaborative basis with Dr. Gallo and his laboratory unless stated otherwise." (Staff Report, p. 127)

Condition included in a special LTCB transfer agreement imposed on Harvard University's Dr. James Mullins, 1984: "Use of H9 will be limited to my immediate laboratory for the specific purpose of transfection of CTV and HTLV-1 DNA. No other experiments will be carried out with this cell line without prior discussions with Dr. Gallo." (Staff Report, p. 131)

Condition included in a special LTCB transfer agreement imposed on Dr. William Haseltine, 1984: "Work performed will be on a collaborative basis with Dr. Gallo, Dr. Popovic, Dr. Wong-Staal, and their colleagues (to be specified by them) for the specific purpose of studying expression of HTLV--LTR linked genes in these cells. No other experiments should be initiated with these cells without prior discussion with the above named people." (Staff Report, p. 132)

Conditions included in special LTCB transfer agreements imposed on scientists at the Centers for Disease Control [CDC] and on NIH laboratory chief Dr. Malcolm Martin, 1984: "Work with HTLV-III will not be published without prior approval by Dr. Gallo" and "Reagents will not be used in comparisons with other viruses." (Staff Report, p. 132)

Condition unique to the special LTCB transfer agreement imposed on scientists at the CDC, 1984: [Referring to LTCB cell lines] "They will only be used for seroepidemiologic studies and blood bank assays." (Staff Report, p. 132)

Gallo to Dr. Malcolm Martin, 22 June 1984: [Concerning the uninfected H9 cell line] "... I do not think it would be appropriate for you to put the French isolate in them. That is for them to do in collaboration with me and my co-workers and is ongoing." (Staff Report, p. 130)

Dr. Peter Fischinger, interview with Subcommittee staff: "I wouldn't do it, but Bob must answer for himself." (Staff Report, p. 136)

Dr. James Wyngaarden, former Director of NIH, interview with Subcommittee Staff: "Clearly inappropriate." (Staff Report, p. 136)

Dr. Vincent de Vita, former Director, NCI: "All restrictions are antiscience .... I think it's terrible." (Staff Report, p. 136)

Richards Panel Report, 19 February 1992, p. 3: "We consider failure to distribute uninfected H9 cells freely after publication of the article by Popovic et al. to be essentially immoral in view of the growing seriousness of the AIDS epidemic." (Staff Report, p. 131)

[From the Executive Summary, p. 8: "In June of 1984, the LTCB scientists began a series of ... genetic comparisons of several HIV isolates, including LAV and 'IIIb'. The results showed that all the isolates were clearly different from each other, with one exception-the 119 and LTCB prototype viruses--which were virtually identical.., there could be no question but that the IP virus was the original virus, i.e., that 'IIIb' came from LAV, and not the reverse.

"... Dr. Gallo ... devised a plan to make it appear that the French, in fact, had appropriated the LTCB virus .... When Dr. Montagnier vehemently objected and would not acknowledge the 'reverse contamination'

scenario, given that the LTCB scientists had LA V long before the IP scientists received 'IIIb'), Dr. Gallo switched to the argument that the viruses, although very much alike, were genuinely independent."]

Fischinger Report, 27 August 1985: 'There is no evidence that material from any outside laboratory including the French, was used in generating the HTLV-IIIb virus" (p. 3) and "It is clear that LAV was not used in generating the HTLV-IIIb virus strain advertently or inadvertently." (p. 8) (Staff Report, p. 166)

Gallo, reported in Science 230, 1985, p. 642: [Concerning the claim by the Institut Pasteur that Gallo's group somehow grew the French isolate] "Gallo indignantly disputes this allegation on several counts, including the fact that the viruses are not identical .... " (Staff Report, p. 38)

Gallo, reported in the Wall Street Journal, 16 December 1985: [Concerning the allegation that Dr. Gallo misappropriated the French virus and presented it in his work, which later was patented] "Dr. Gallo refutes this, saying that the LAV and HTLV-III strains, although related, aren't identical .... Besides, the single LAV sample was too small to be of practical use, he argues" (Staff Report, p. 203)

Defendant's Motion for Summary Judgment, II June 1986, U.S. Court of Claims pp. 8-9: "Neither of these inventions [the Gallo et al. blood test and cell line] depended on or is derived from LAV isolates of the virus that is responsible for AIDS were available from many sources, and in fact, it was from these independently established isolates that HTLV-III was found." (Executive Summary, p. 55)

Memorandum in Opposition to Defendant's Motion for Summary Judgment, U.S. Court of Claims, 8 April 1986, p. 6: "The scientific evidence is clear that HTLV-III and LAV are not so similar that HTLV-III can be said to be the progeny of LAV," (Executive Summary, p. 55)

Brief for Appellee the United States, U.S. Court of Claims, 22 May 1986, p. 4: "Continuing research revealed that LAV and HTLV-III were two different isolates of the AIDS virus." (Executive Summary, p. 55)

U.S. Government Attorneys in the U.S. Court of Claims, Oral Arguments, 22 May 1986: " there are significant differences between the structure of HTLV-III[b] and LAV and you just can't say that HTLV-III is LAV by another name." (Staff Report, p. 213)

Brief for Appellee the United States, U.S. Court of Claims, 13 November 1986, pp. 4-5: "... Pasteur's statement that '[It] appears that Dr. Gallo and certain of his colleagues essentially took LAV, renamed it HTLV-III and the [sic] claimed and exploited it as their own' ... is an outrageous attempt to impugn the reputation of one of the world's foremost virologists and his coworkers." (Executive Summary, p. 56)

Wong-Staal, Gallo et al., unpublished manuscript prepared after the above-mentioned experiments were performed, 1984: "LAV and HTLV-III [including 'IIIb"] are independent isolations of the same virus." (Staff Report, p. 117)

Ratner, Gallo, Wong-Stall et al., Nature, 313 (1985), pp. 636-637: "HTLV-III[b], LAV, and ARV [another early HIV isolate] are variants of the same virus ... the closer similarity of the LAV DNA sequence to that of HTLV-III might be because the individuals from whom these isolates were derived acquired the virus at a similar time and place." (Staff Report, p. 166)

Gallo, draft statement, 17 April 1989, never published: "Can we conclude ... that HTLV-IIIb and LAVB BRU did indeed originate from the same individual? If that is indeed the case, it would only have resulted from a mix-up in my laboratory when the LAV from Luc Montagnier was temporarily growing along side the other isolates we had obtained. We certainly cannot rule this out, particularly since we and, I am told, many other investigators have often experienced the phenomenon of laboratory contamination of HIVs ... I do ... think it is necessary as a result of the data compiled in this book to acknowledge the distinct possibility that HTLV-IIIb and LAV BRU are the same isolate." (Staff Report, pp. 264-265)

Gallo to Myers, 5 April 1990:²"I have wanted to tell you for some time--that you were certainly right, and I should have listened to you ... as early as 1984, I told her [a reporter for Science] IIIb could be a contaminant of LAV. Because of everything else we did and because of other isolates and because of the help I gave Montagnier early on, I just could not believe anyone would really care." (Staff Report p. 267)

Gallo, "Opening Scientific Statement" to OSI, 6 April 1990: "With time and more sequences available the relative similarities of this pair (LAV and IIIb) remains unusual but not unique." (Staff Report p. 266)

Gallo, OSI Interview, 8 April 1990, transcript p. 34: "Shortly after our papers appeared in May '84, three of these isolates ... were analyzed and shown to be distinct from ... each other by restriction endonuclease analyses. RF, MN, and JS [the three LTCB isolates] were also shown to be very different from LAV, but IIIb was similar to LAY." (Staff Report p. 102)

Gallo, OSI Interview, 11 April 1990, transcript p. 82: "I'm interested in a vaccine and in curing the disease. I'm interested in basic science and how the virus works. Do you think I'm going to get back there in the mud of whether IIIb and LAV came from this lab or the other lab when I have all kinds of other isolates and things are moving like a bullet? And I want to be worried about that, and did it happen in my lab, or their lab . . . I mean, who bloody cares?" (Staff Report, p. 267)

Gallo, OSI Interview, 11 April 1990, transcript p. 71: "I have felt it is an irrelevant question, for the most part ... scientifically, ethically, medically and historically, because there are so many other isolates and if anybody had half as many in tissue culture within the next year I would be surprised, so I've never felt it to be an important question. It's only in this context of the questioning

that I'm getting here that it becomes important or for politics that have been played in newspapers .... " (Staff Report, p. 267)

Gallo, OSI Interview, 11 April 1990, transcript p. 72: "... I would conclude that there can't be a conclusion today .... I don't think we can make any conclusive statement .... Also, please keep in mind that though I said if this possibility or probability exists ... I didn't tell you where it [contamination] happened with certainty also. I believe that question is open, no matter what information you may have .... " (Staff Report, p. 266)

Gallo, in Virus Hunting, 1991, pp. 197-199: [Referring to experiments made in 1984] "About this time (June-July) Wong-Staal [Dr. Flossie Wong-Staal, another LTCB scientist] compared the genetic material of LAV with our isolates ... we learned that there was considerable variation in the viral genome when comparing one isolate to another .... Last and most unsettling, we discovered that one of our own HTLV-3B isolates was much closer to LAV than was typical of our other isolates .... Practically all were genetically different from one another. Yet LAV and our IIIb isolate(s) were distinctly close to each other." (Staff Report, p. 103)

Gallo to IP scientist Dr. Simon Wain-Hobson, 24 July 1991: [Referring to the 1984 experiments described immediately above] "Our conclusion was that we had a serious contamination problem .... " (Staff Report, p, 101)

Dr. Gerald Myers to Dr. John LaMontagne et al., 8 April 1987, p. 4: "... it is the astonishing and unforeseen variation of the virus, which exposes the fraud .... I suggest that we have paid for this deception in more than the usual ways. Scientific fraudulence always costs humanity ... but here we have been additionally misdirected with regard to the extent of variation of the virus, which we can ill afford during the dog days of an epidemic let alone during halcyon times." (Staff Report, p. 263)

Dr. Gerald Myers to Gallo, 20 September 1988, p. 1: "From our earliest tree analyses, it was patently evident that the IAV and IIIb viruses had to have had a recent common ancestor .... By including all of the available gene sequences in a single analysis for the IIIbs, it is actually possible to define the branching order

of the variants to a high degree of statistical precision. There is no doubt but that it shows the LAV source of the IIIb viruses: the NL43 clone of the [LAV] BRU isolate is the oldest sequence; the published BRU follows it; the IIIbs follow thereafter . . . " (Staff Report, p. 264)

[From the Executive Summary, p. 54: "The U.S. Government pleadings, particularly those in the Claims Court and at PTO, contain numerous misleading claims. They also reflect numerous material omissions. The misinformation and material omissions are traceable directly to documents and statements prepared by Dr. Gallo and his LTCB colleagues, including numerous statements in the scientific literature, and documents and statements originating with Dr. Gallo's NCI and HHS superiors, including but not limited to Drs. Peter Fischinger and Lowell Harmison.']

Gallo, certification of accuracy and reliability of the scientific content of the "Fischinger Report," August 1985: "The enclosed attachment ... has been reviewed by me relative to the fidelity of specific information presented as well as the accuracy of its interpretation. These data are substantiated by entries in the notebooks, as well as by other records emanating from the Laboratory of Tumor and Cell Biology, NCI." (Staff Report, p. 161)

Gallo, interview with Subcommittee staff, July 1993: "I didn't read it [the Fischinger Report] as carefully as you might think." (Staff Report, p. 184)

Dr. Peter Fischinger, interview with Subcommittee staff, 1993: "My major point of discussion was Bob. No question about that. In terms of him trying to organize or find some of the data, some of the things that were going. I was listening to him as the point person ....

I had a sense, at least from my perspective, there is laboratory data. Bob sort of swears that this is the way it is, and the laboratory data sort of generally support it, as opposed to no data. Then that's going to be his, sort of, ultimate responsibility. That was my feeling. So I would rely, myself, from a scientific point of view, in terms of what they did in the lab, he has the best knowledge, he should have the control of it.

My feeling was that Gallo has to go, and demonstrate this, and he has to defend what he has done, he has kind of sworn to the fact that he did what he did, and the fact that this is something that could stand in terms of his own laboratory's merit. And he sort of claims it even in terms of specifics, and has an argument that I could sort of believe in that is strong enough.

I said, 'Look, this is what you did. This is the summation of [what] you had said in your laboratory data to prove it. And let's take it from there.'" (Staff Report p. 160)

Gallo, OSI Interview, transcript pp. 99-109: "... I was asked by the United States Government to draw a lineage to the first time we detected this virus to show lineage of our work. You see what has happened as a scientist I am being put into a legal position, which I am not used to ... when I am asked to go back and draw lineage to our first experiments that have positive indications, that is what I did for the government .... But that wasn't for me to get scientific credit. Just suddenly I am in a legal thing. I am back to a morality ethics thing issue." (Staff Report, p, 17)

Gallo's attorney Joseph Onek, OSI interview, 3 August 1990, transcript p. 153: [Concerning Gallo's sworn declaration] "I should point out that, of course, this is a statement like any affidavit, but I am sure was prepared by lawyers, not by Bob .... " (Staff Report, p. 210)

U.S. Government motion for extension of deadline, PTO interference, 30 June 1986, pp. 3-5: 'The complex nature of the subject matter of this interference and the voluminous experimental work which led to the development of the patented invention [the Gallo et al HIV blood test] also require the personal participation of Dr. Robert C. Gallo .... Only Dr. Gallo is thoroughly familiar with the records relating to these developments ... the personal assistance of Dr. Gallo is of the utmost importance in pursuing these investigations." (Staff Report, p. 207)

From the Staff Report concerning an interview of a patent attorney with the staff, p. 19: "Another outside patent attorney said that for the most part, he had to rely on interviews with Dr. Gallo or his associates as a source of information. The attorney said he asked the LTCB scientists, 'Do you have data to support these claims?' and, 'Sometimes the data were provided; often they were not.' But, said this attorney, 'I never had any reason to doubt what I was told.'

When confronted with significant pieces of data that contradict the claims of Gallo et al., this attorney responded, 'You're telling me things I know nothing about.'"

U.S. Government attorney, interview with Subcommittee staff: "Here's this guy, almost a Nobel Prize winner, you walk in his office and see all these awards all over the walls--if he tells us he did something, are we going to question it?" (Staff Report, p. 19)

HHS contract attorney, interview with Subcommittee staff: "Believe me, I didn't know enough to lie." (Executive Summary, p. 53, Staff Report p. 19)

PARTIAL LISTING OF DOCUMENTS DELAYED OR NEVER PROVIDED TO THE SUBCOMMITTEE BY HHS OR DOJ

[From the Executive Summary, p. 14. "In addition to the documents listed below, a substantial number of significant documents were altered and/or redacted before they were provided by Gallo et al to OSI" and hence to the Subcommittee.]

Never provided. OSI staff notes from the Gallo investigation--destroyed in 1992 by order of then-OSI Director Dr. Jules Hallum, despite an outstanding Subcommittee document request. Executive Summary, p. 14)

Never provided. All documents from the office of Dr. Lowell Harmison, formerly HHS Science Advisor to the Assistant Secretary for Health and a major player in the HIV blood test dispute. By his own admission, the documents were removed by Dr. Harmison and allegedly discarded, on the occasion of his retirement from HHS in late 1987. Executive Summary, p. 14)

Never provided. All documents from the office of C. McLain Haddow, formerly Chief of Staff to HHS Secretary Margaret Heckler and a major player in the early days of the blood test dispute. Haddow told Subcommittee staff he left all his documents in his office. Only a single Haddow document was provided to the Subcommittee by HHS. (Staff Report, p. 187)

Never provided. (a) LTCB data from the initial 1984 experiments showing the IP and LTCB prototype HIV isolates were genetically identical; (b) LTCB data associated with the unpublished 1984 Lancet manuscript that reported the IP and LTCB isolates were "independent"; (c) documents associated with the LTCB scientists' 1984 review of the Bryant et al. manuscript that reported the genetic identity of the IP and LTCB HIV isolates. (Executive Summary, p. 15; Staff Report, pp. 92, 118)

Withheld nearly one year. Numerous highly significant documents generated by or previously in the possession of former NCI Associate Director Dr. Peter Fischinger, including documents showing how NCI misled then-Assistant Secretary of Health, Dr. Edward Brandt, concerning the identity of the IP and LTCB HIV prototype isolates. The "Fischinger documents," known by the Subcommittee to exist, had been provided by NIH to a pharmaceutical firm in connection with a 1992 lawsuit. The documents were not provided to the Subcommittee despite repeated, specific requests. They finally were given up just hours before the Subcommittee staff visited the NIH campus to interview witnesses about the "missing" Fischinger documents. (Executive Summary, p. 41; Staff Report, p. 112)

Withheld nearly two years. Peter Fischinger's August 1985 "Major Areas of Oversight" memorandum to Dr. Gallo, showing Dr. Fischinger's concern with, among other things, the failure of Gallo and his associates to confirm they did not us LAV in isolating the LTCB's putative prototype virus "IIIb." (Executive Summary, p. 46; Staff Report, p. 173)

Withheld nearly two years. Memoranda to Dr. Harmison from NIH laboratory chief Dr. Malcolm Martin reporting Dr. Martin's laboratory data that pointed to the strong probability the IP and LTCB prototype HIV isolates were genetically identical, with the putative LTCB isolated derived from the IP, and not the reverse. One of these vitally important memoranda was located in Dr. Gallo's files, over three months after Dr. Gallo signed an affirmation that he had provided all responsive documents to the Subcommittee and asserting that: "I really do not know what Mr. Dingell is referring to in terms of documents not received relating to the patent." (Staff Report, p. 176)

Withheld nearly two years. The "Myers documents," dating from 1987-1990, showing proof of the genetic identity of the IP and LTCB prototype HIV isolates. (Executive Summary, p. 15. Staff Report, p. 263)

Withheld nearly two years. All documents relating to Dr. Bernadine Healy's committee of "wise men," by which Dr. Healy attempted--and mostly failed--an end run of the "Richards committee." (Executive Summary, p. 57)

The Chicago Tribune reported on the Dingell Staff Report ("In the Gallo case, truth termed a casualty," 1 January 1995, p. 1), and followed this article by a scathing editorial "Defending the indefensible Dr. Gallo" (6 January 1995). A few days later, I received a fax from Gallo stating: "In view of your continued assassination of my character and the enormous amount of time you have put into distributing unfair and ridiculous [sic] attacks on me, I trust that in fairness you will circulate these two enclosures (3 pages which follow), written by Bernadine Healy and my lawyer, Joseph Onek." I did circulate these documents, which I reproduce below, together with replies which Gallo did not send to me but which I received directly from the parties involved. I also included samples of false statements by Gallo and his lawyer (vide supra).

LETTER FROM BERNADINE HEALY
to the Chicago Tribune
19 January 1995

No conspiracy in HIV controversy

CLEVELAND---In his Final spasm as outgoing chairman of the Energy and Commerce Committee, Rep. John Dingell (D-Mich.) heaved another package of fabrications and distortions. These latest accusations arrived in an allegedly unauthorized, "leaked," secret draft report on a three-year investigation of a controversy surrounding the 1984 discovery of the AIDS virus (HIV) reported by the Tribune Jan. I.

One hopes this marks the end of Dingell's deluded notions of a multi-administration conspiracy to protect Dr. Robert Gallo, one of the discoverers of HIV who also developed the blood test for HIV.

At enormous taxpayer expense, Dingell has pursued Gallo and attacked anyone who has refused to join in his crusade.

The former chairman first accused me, as then-director of the National Institutes of Health, of "replacing" an employee of the NIH's Office of Scientific Integrity (OSI) who wrote a report that was "sharply critical of Dr. Gallo."

This employee was never replaced. On the contrary, before I arrived at the NIH, she requested and was given a new job in an unrelated department. She was also given leave at that time to complete her work on the Gallo case. I did ask her to revise the amateurish and poorly written report for style and structure, but when she complained that revision would change the meaning, I withdrew my request immediately. I subsequently accepted the employee's report which ironically, though critical of some of his actions, had always exonerated Dr. Gallo of misconduct.

Second, the former chairman contends that I "bypassed" the "conclusions" of an advisory committee in accepting the OSI report that exonerated Dr. Gallo. In fact, I was presented with several non-binding recommendations of advisory groups, all of which advised acceptance of the report except one. The one contrary recommendation came from a committee that refused to consider evidence or testimony from the accused.

I easily could have ignored all other findings in favor of the advice from the one flawed advisory committee. Instead, I made an independent judgment that, after careful review, seemed to me to be correct.

My unwillingness to be a pawn in the former chairman's smear campaign prompted further false accusations. An example is the third charge in his report, his invention of a conversation in which I told him that I felt I had to "save Bob [Gallo]." I never made such a preposterous statement.

As the head of an agency that was a frequent target of Dingell's witch-hunts, I saw first-hand the abuse of power by a long-time committee chairman and his staff acting as secret police, prosecutor, judge and jury under the old House rules. Americans would be shocked to learn of the clandestine tape recordings, document theft, threats, foul-mouthed verbal rantings and abusive closed-chamber interrogations of the former chairman and his staff of over 100.

Immune from the Freedom of Information Act and the laws against libel and slander, Dingell and his staff operated in virtual secrecy, withholding any documents that displayed its methods of operation or contradicted its fabricated story line. This gave them carte blanche to make reckless and unsupported statements about people or institutions.

Let the actions of Dingell and his bloated staff be a memorial to what went wrong with Congress after 40 years of single-party rule.

Bernadine Healy
STAFF, CLEVELAND CLINIC FOUNDATION
FORMER DIRECTOR, NATIONAL INSTITUTES OF HEALTH

REPLY TO BERNADINE HEALY
Chicago Tribune, 12 February 1995

Report found scientific misconduct

Dr. Bernadine Healy's January 19, 1995 letter concerning the congressional subcommittee draft staff report in the Dr. Robert Gallo case was characteristically inconsistent with the facts. As former NIH and Subcommittee investigators in this case, we write to set the record straight.

Dr. Healy's orders for changes in the NIH Gallo report did not bear merely on the "style and structure" of the report. Independent memoranda to Dr. Healy from the then-Director of the NIH Office of Scientific Integrity (OSI) and the chief investigator (supported by the then-Deputy Director of NIH) protested that Dr. Healy's ordered changes, "would be damaging and enervating" and would "significantly vitiate the findings" of the Gallo report.

Contrary to Dr. Healy's claim, the NIH Gallo report did not "always exonerate[d] Dr. Gallo of misconduct." The penultimate version of the draft report found Dr. Gallo guilty of scientific misconduct (in the controversy surrounding the discovery of the AIDS virus), while the final version of that report found that Dr. Gallo "created and fostered conditions that gave rise to falsified/fabricated data and falsified scientific reports" and Dr. Gallo's actions "warrant significant censure."

Based on these findings and other contemporaneous situations of wrongdoing in the Gallo laboratory, Dr. Healy's predecessor decided to initiate a formal evaluation of Dr. Gallo's fitness to serve as an NIH laboratory chief. These plans, of course, were preempted by Dr. Healy's arrival at NIH.

Dr. Healy did indeed replace the NIH chief investigator in the Gallo case, ordering that the investigator be "reined in" and "make no further decisions" in the case. Moreover, Dr. Healy ordered an investigation

of the chief investigator herself, an investigation that the then-OSI Director described in memoranda to NIH attorneys and Dr. Healy herself as "improper" and "a threatening intimidation."

The "flawed advisory committee" was in fact a panel of distinguished scientists nominated by the National Academy of Sciences to oversee the NIH investigation. Contrary to Dr. Healy's assertion, this committee examined extensive evidence submitted by Dr. Gallo and his associates.

Concerning her implication that partisan politics produced her stormy relationship with the subcommittee, Dr. Healy seems to have forgotten just how bipartisan the subcommittee was in its dealings with her. During the subcommittee's August 1991 hearing into Dr. Healy's firing of the Gallo chief investigator, as well as Dr. Healy's mishandling of a misconduct investigation at her own Cleveland Clinic Foundation, Rep. Thomas J. Bliley (R-Va.), then the ranking Republican on the subcommittee, observed that Dr. Healy's mishandling of the Cleveland Clinic investigation ."..raises questions about Dr. Healy's willingness to vigorously pursue allegations of scientific misconduct .... "

In short, contrary to her mutterings about "single-party rule," Dr. Healy's adversarial relationship with the Subcommittee was entirely of her own making.

Peter D. H. Stockton
(former investigator on the Subcommittee on Oversight and Investigation)

Suzanne W. Hadley, Ph.D.
(former OSI Deputy Director and chief investigator of the NIH Gallo investigation, subsequently an investigator with the Subcommittee on Oversight and Investigations)

The Cancer Letter
Vol. 21, No. 5, 3 February 1995

Letter to the Editor

Gallo Attorney: Subcommittee Report Full of Errors, "Drivel"

It would require a volume to respond fully to all the errors in the draft report on the AIDS blood test patent as described in The Cancer Letter of Jan. 6. Here are just a few points your readers should consider:

1. The Institut Pasteur did file a patent application for an AIDS blood test several months prior to Dr. Gallo and his colleagues. The problem with the application is that it expressly stated that the test scored positive in only 20 percent of AIDS patients. In short, the test was essentially useless.

2. As a practical matter, there could be no AIDS blood test until the scientific community was convinced that a new retrovirus (now called HIV) was the cause of AIDS. It was Dr. Gallo and his colleagues who demonstrated the etiology of AIDS in four landmark papers published in Science in May 1984. Similarly, there could be no blood test until HIV isolates could be grown in significant quantity. It was Dr. Gallo's colleague, Dr. Popovic, who accomplished this breakthrough, as described in one of the four Science papers. Finally, there could be no blood test unless the test scored positive in most AIDS patients. Dr. Gallo and his colleagues described such a test in the Science papers. The information in the Science papers provided the basis for the Gallo blood test patent filed in April 1984.

3. Neither the Centers for Disease Control nor the Institut Pasteur had any credible results comparable to Dr. Gallo's at the time the Gallo blood test patent was filed. In fact, in May 1984, CDC and Pasteur scientists submitted a paper to Science (published in July 1984) describing a test that scored positive in only 41 percent of AIDs patients. The article also stated that "it is possible" that the French virus and the American virus were the same subtype. Thus, at the time the Gallo patent was filed, the Institut Pasteur did not have a comparable blood test and there was insufficient evidence to demonstrate that the French and American viruses were the same subtype.

4. Dr. Gallo and his colleagues did use the French virus HIV-Lai in their blood test.

But this use was accidental in two senses. First, HIV-Lai accidentally contaminated the American isolate HTLV-IIIB just as it contaminated the isolated LAV-Bru in the Institut Pasteur and contaminated isolates in the laboratories of Dr. Robin Weiss and others. Second, Dr. Gallo's laboratory could have used a different isolate, RF, for the blood test. The draft report's suggestion that RF was not ready demonstrates a total ignorance of the facts. RF was growing well by early 1984, as laboratory records attest. Dr. Gallo's laboratory did not send out HTLV-IIIB for use in the blood test until April 1984. Dr. Gallo's laboratory clearly could have scaled up RF for use in the blood test by April if it had chosen to do so.

5. The draft report's claim that Dr. Gallo and his colleagues hid information is laughable. Even before the patent application was filed, Dr. Gallo went to Paris and arranged for the Institut Pasteur and his laboratory to prepare joint papers concerning the French and American viruses. These papers were prepared, but were not published at the request of the French. In May 1984, only three weeks after the patent application was filed, Dr. Gallo provided the Institut Pasteur with a sample of HTLV-IIIB to work with. Dr. Gallo and his colleagues then conducted most of the studies that led to the discovery of the close similarity between the French and American viruses and then to the discovery of the dual contamination. It was Dr. Gallo and his colleagues who first reported that the AIDS virus, unlike HTLV I and II, was heterogeneous. It was Dr. Gallo's laboratory that reported the sequence of the HTLV-IIB isolate, thus making comparison to the French isolates possible. It was Dr. Gallo's laboratory that reported that HTLV-IIIB and the French isolates LAV-Bru were different. This led to the Institut Pasteur's belated discovery in 1991 that LAV-Bru had been contaminated by HIV-Lai in its laboratory in 1983. Finally, once the Institut Pasteur explained about the contamination that had occurred in its laboratory, Dr. Gallo promptly acknowledged that his laboratory had accidentally used HIV-Lai in its blood test. This acknowledgment was made in 1991, well before any studies by independent laboratories or Dr. Varmus' statement in 1994.

It is bad enough that The Cancer Letter devoted so much space to such drivel. But its use of Dr. Suzanne Hadley as a commentator is truly extraordinary. Dr. Hadley's bias and incompetence are well known: every major scientific misconduct report she has worked on has been thrown out. Perhaps The Cancer Letter

will now rely on tobacco executives to provided commentary on the causes of lung cancer

Editor's Note: The Cancer Letter decided that in light of Mr. Onek's comments about her, Dr. Hadley was owed the opportunity to respond. Her response follows.

Mr. Onek would do well to examine the facts in the Subcommittee staff report, rather than trotting out yet again the same irrelevancies and unsubstantiable claims that for years have characterized his and Dr. Gallo's responses concerning these matters. Mr. Onek's claim that the Gallo laboratory could have used the RF isolate for its HIV blood test is just one example of numerous Gallo/Onek claims that are compellingly disproved by the evidence detailed in the staff report.

As for Mr. Onek's gratuitous, plainly silly comments concerning The Cancer Letter's choice of commentators, they hardly warrant a response. However, since Mr. Onek has raised the issue of competence of Office of Scientific Integrity investigations, I gladly take the opportunity to acknowledge that OSI missed the boat in one major scientific misconduct case, i.e. the investigation of Dr. Gallo and his colleagues. As the former chief investigator in the case, I can say with certainty that no one at OSI comprehended the extent, seriousness, and systematic quality of the falsehoods that were perpetrated in this case. Nor, certainly, did we comprehend the significance of the official imprimatur that years earlier had been stamped on these falsehoods. In short, we had no idea what we were up against.

The stakes became clear in the spring of 1991, when an OSI report that pointed out numerous false statements in the Gallo et al. patents and related US government pleadings was dismissed by NIH/HHS attorneys with the offhand comment that, "We don't think there's a problem here." Shortly after preparing this report, I was forced to resign as chief investigator in the Gallo case.

Fortunately, thanks to Congressman John Dingell and the subcommittee, this was not the end of the matter. The full text of the subcommittee staff report is now available, on the World Wide Web at the following URL number:

The scientific community and the public finally can examine the evidence and make their own judgments about these important matters. They will find the staff report solid in all its findings.

Copies of the Subcommittee Staff Report circulated widely, partly because of my mailing, and party because others (such as Stewart-Feder) also publicized it. I received a letter from Kenneth Ryan³ (postmarked 7 February 1995), acknowledging receipt of this Staff Report, and stating: "I will have it reproduced for all our Commission members. It obviously should inform our work and help in our deliberations. I am wondering whether the new congress will be at all interested in it. It will be interesting to see what the response of the scientific community will be. You are to be commended for taking the time and effort to deal with the scientific integrity issue."

Some documents pertaining to the Staff Report were sent by Stewart and Feder to Harold Varmus, the new Director of NIH. Hearing that Varmus was unhappy with the Staff Report, Dingell wrote to Varmus a letter dated 3 February 1995:

The events recounted here (§2 and §3) were summarily and effectively described in a Science and Government Report article: "Dingell Ex-Staffers Release Critical Report on Gallo" (15 February 1995, p. 5). According to this article: "SGR hears that Varmus, not pleased with the [Dingell Staff] report, sought advice from Harriet S. Rabb, General Counsel of the Department of Health and Human Services, who also gets knocked in the report. Rabb took up the matter with Dingell's staff chief, Alan J. Roth, who from way back doubted the political value of Dingell's clashes with the scientific establishment. The cautious solution was Dingell's letter to Varmus, not wholly repudiating the report--which after all, was produced under Dingell's chairman-ship--but casting doubt on its status as an official Congressional product."

I want to conclude here by emphasizing political, institutional, and journalistic responsibilities involved in Dingell's letter to Varmus. Nowhere in his letter did Dingell disavow the Staff Report itself. However, the letter lent itself at the time to interpretations discrediting the Staff Report. For example, Dingell wrote: "We cannot vouch for the authenticity or accuracy of the papers provided to you." (Dingell is here referring to the documents sent to Varmus by Stewart and Feder.) This sentence is an abdication of responsibility, but it does not assert that the Staff Report is deficient in any way.

Nevertheless, the sentence sets a context for an innuendo subject to many interpretations, namely Dingell's subsequent statement that an "early draft on the matter had been rejected by the Subcommittee staff director several months ago." What does this rejection mean? For what reasons? Because the draft was 1,200 pages long (as I am told by a member of the staff at the time)?

- Dingell's introduction to the Harmison hearings (21 July 1993), where he stated: "When the U.S. Government sought a patent on its alleged 'discoveries' relative to the HIV blood test, officials apparently withheld from the U.S. Patent Office information directly and materially relevant to the examination of the Government's patent applications---information showing the claimed invention actually had been made long before by other scientists."

- Dingell's very critical letter to the 1992-NIH Director Bernadine Healy, dated 26 November 1992, as reported in Science and Government Report (cf. § 1).

- Dingell's letter to the 1994-NIH Director Harold Varmus dated 23 February 1994, where he stated: "The contents of the Myers/NIH correspondence are summarized in a Subcommittee staff memorandum attached to this letter. The substance of the 'Myers' documents (and their greatly belated submission to the Subcommittee, not to mention the fact that the documents were never provided to OSI, ORI or the HHS OIG) are matters of considerable concern. The contents of these documents, particularly in light of the conclusions of the Richards Committee and many members of Dr. Healy's irregular secret committee, raise renewed concerns about Dr. Gallo's veracity and forthrightness on these matters."

In contrast with these earlier positions, Dingell's 3 February 1995 letter to Varmus is so ambiguously worded as to promote interpretations which would undermine his Staff Report. I regard such a letter as a betrayal of what he stood for over the last several years, since his Subcommittee started investigating the Gallo case, following the Baltimore case.

Fortunately, the credibility of the Staff Report does not depend on Dingell or anyone else. Indeed, the Staff Report itself does not ask to be taken on trust. It confirms the ORI Offer of Proof and the HHS Inspector General's Memorandum as far as they went. It gives factual documentation, putting an entire story together,

and refers meticulously to the record, which is verifiable. Anyone can check out its factual assertions, as well as the direct quotes from Gallo himself or his lawyer.

Dingell trumpeted over several years in the name of truth, and in the name of scientific and political responsibility. He was supported and encouraged by a few scientists who went on the line despite a hostile reaction by scientists at large. He used his staff, and persons such as Suzanne Hadley who made heavy professional commitments. After all these dealings, for him to have issued a letter to Varmus such as the one he did on 3 February 1995, lending itself to interpretations stemming from ambiguities and innuendo's contained in the letter without his actually taking responsibility for the interpretations, which some people are using in early 1995 to discredit everything he claimed he stood for in the last few years, is a betrayal of truth, of scientific and political responsibility, and of the people who trusted him.