Extract∙Institutional Response to the Blood Test Patent Dispute and Related Matters

Extracts from Staff Report of the Subcommittee on Oversight and Investigations Committee on Energy and Commerce United States House of Representatives
23 January 1995
Selection by Serge Lang of Yale University

An Overall Comment, Among Many Others

Executive Summary (here). "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."

[Following are excerpts from the Executive Summary and Staff Report reflecting 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 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.]

I(a). Claims that Gallo et al. isolated HIV in 1982

[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). I reproduce some of these quotes. S.L.]

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)

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)

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)

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 Report)

I(b). Subsequent Shifts and contradictions

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)

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)

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)

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)

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

II(a). Claims that the IP Virus Did Not Grow at the LTCB

[According to 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..." (here) ... the IP virus, under its own name, grew at least two-to-three months at the LTCB..." [ beginning in the Fall of 1983(here)]

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)

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

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 LAV" (p. 3). (Staff Report)

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)

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)

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

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)

II(b). Shifts and Contradictions

Gallo, OSI interview 18 July 1990, transcript p. 65: [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)

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)

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)

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)

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)

III(a). Obscuring the Origins of the First HIV-Permissive Cell Line

[According to 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." ]

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)

Fischinger Report, NCI's official response to the blood test patent dispute, certified by Dr. Gallo as true and supported by data, p. 10: [Referring to the original HUT-78 cell line] "...which is a relative of the HT cell line developed by Dr. Gallo..." (Staff Report)

III(b). Shifts

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; see Staff Report)

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. 1500)...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)

III(c) Comments by Other Scientists

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)

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 Minus 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)

IV(a). Withholding/Restricting Use of Cell Lines and LTCB Reagents

[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." "...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)]

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)

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)

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)

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)

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)

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)

IV(b). Comments by Other Scientists

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

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

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

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)

V(a). Genetic Identity of the IP and LTCB Viruses

[According to the Executive Summary: "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 isolated were clearly different from each other, with one exception -- the IP 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 LAV 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)

Gallo, reported in Science 230, 1985, p. 642: [Concerning the claim by 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)

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)

Defendant's Motion for Summary Judgment, 11 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)

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)

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)

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)

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)

V(b). Shifts and contradictions

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)

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)

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)

Gallo to Myers, 5 April 1990 (for statements by Gerald Myers, see below): "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)

Gallo, "Opening Scientific Statement" to OSI, 8 April 1990: "With time and more sequences available the relative similarities of this pair (LAV and IIIb) remains unusual but not unique." (Staff Report)

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 LAV." (Staff Report)

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)

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)

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)

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 out IIIb isolate(s) were distinctly close to each other." (Staff Report)

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)

V(c). Evaluations by Gerald Myers

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)

Dr. Gerald Myers to Gallo, 20 September 1988, p. 1: "From our earliest tree analyses, it was patently evident that the LAV 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)

VI. Responsibility for False and Misleading Statements

[According to the Executive Summary: "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 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)

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

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)

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)

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)

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)

From the Staff Report concerning an interview of a patent attorney with the Staff: "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)

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

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

[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. (Executive Summary).]

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)

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)

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)

Never provided. All attorneys' notes from the U.S. Department of Justice.

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; Staff Report, here and here)

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; Staff Report)

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; Staff Report)

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 revers. 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)

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. Staff Report)

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)

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