IV. Events Leading to the April 1984 HHS Announcement

During the end of 1983 and through the first quarter of 1984, the LTCB made considerable progress in its work with the AIDS virus, virtually all of it with LAI (as LAV, then as MOV and IIIb). By mid-December 1983, Dr. Popovic was attempting to grow a small number of authentic LTCB isolates in the HUT-78 cell line, based on his successful experience with LAI. Several of these other isolates eventually were established in permanent cell lines. Some were published in the May 1984Sciencepaper by Popovic et al. But nothing grew in permanent cell lines as well as did LAI.

A. Further Work with LAI/MOV

During December 1983, work on LAI/MOV moved into high gear. Dr. Popovic's notes show that in December 1983, he sent substantial quantities of MOV to LTCB collaborator Dr. M. Sarngadharan. Sarngadharan performed early protein chemistry experiments with LAI/MOV, the results of which, he told OSI, were "extremely exciting," proving to him that MOV was a new retrovirus (5/10/90 Gallo submission to OSI, Exhibit 5, p. 1). In January 1984, Sarngadharan's associate, Dr. Jorg Schupbach, performed experiments with LAI/MOV that, according to a letter from Dr. Schupbach to OSI, showed him that MOV "had to be the AIDS agent" (10/05/90 letter to OSI, p. 2).

In late-December 1983, MOV was used to inject a rabbit, with the objective of producing the first HIV-specific reagent. The experiment succeeded, and by late-February, the resulting hyperimmune rabbit antiserum was available for use to test LTCB samples for the presence of the suspected AIDS virus. (As noted previously, there is compelling evidence that the first cultures so tested were the two LAI/LAV cell lines.)

According to Dr. Gallo's own submission to OSI, LAI/MOV was used to raise the rabbit antiserum until June of 1984, when it reportedly was replaced by LAI/IIIb. This circumstance is telling evidence that the allegedly problematic HTLV-II cross-reaction observed with "MOV" -- if it actually occurred -- was not a hinderance to the continued significant use of MOV at the LTCB. Thus, the putative cross-reaction is not a credible explanation for the LTCB scientists' failure to report the existence and use of MOV, and for its alleged "replacement" with IIIb.

Besides the rabbit antiserum, LAI/MOV also was used as the source of the antigen for the LTCB HIV antibody blood test. Dr. Sarngadharan reportedly initiated the LTCB ELISA on January 6, 1984, using "MOV" as the source of the antigen. (Note, however, that the antigen source is not identified in the laboratory notes. Dr. Sarngadharan's instructions to his technician describe the source of the antigen merely as "the virus we had been analyzing."

According to Dr. Sarngadharan's testimony to OSI, by January 20, 1984, he had fine-tuned the LAI/MOV ELISA to the point that it was "extremely specific and sensitive" for the AIDS virus (5/10/90 "MOV" Submission to OSI; p. 3). (The blood sample used as the standard for AIDS/pre-AIDS in the initial ELISA testing at the LTCB was identified as "LAV." Presumably, this was the BRU serum received from Dr. Montagnier shortly before, in December 1983.)

Notwithstanding Dr. Saragadharan's claim about the performance of his blood test as of January 20, 1984, by Dr. Gallo's own testimony, it was not until February 29, 1984, that "the critical serology" (the "Guroff Panel" of sera) was performed. The ELISAs performed on this date were done using LAI/MOV as the antigen. According to Dr. Sarngadharan's testimony to OSI, concerning these assays:

"When the test results were analyzed and the code was broken in Dr. Gallo's office he was convinced as I was that we had a reliable test" (5/10/90 "MOV" submission to OSI, Exhibit 5; p. 4).

Meanwhile, in January and February 1984, LAI/MOV was sent to two LTCB contract facilities for large-scale production. The contractors in turn provided MOV to the molecular biologists at the LTCB, who used it to, among other things, develop the first cDNA probes for HIV. As previously described, these experiments were reported in at least two papers published by the LTCB scientists to have originated with the "pool" virus IIIb (seeabove).

B. Work Reportedly Done with "HTLV-IIIb"

1. Origins of H9/IIIb:

As late as January 2, 1984, six-to-seven weeks after the claimed initiation of the "pool" culture on November 15, 1983, the culture, by Popovic's own account, was showing signs of an imminent demise. These circumstances came about despite one reported reinoculation of the culture with fresh material from the same three samples used to start the culture and despite an unknown number of refeedings of the culture with fresh HUT-78 cells. According to Mikulas Popovic, the "pool" culture was,

"... not well established ... and I was afraid that I would lose the culture. Therefore, I told myself, oh good god, I won't have it .... So it was a fear behind it, I would say, that I would lose the culture .... So what I tried to save the culture was to reinfect it again" (6/26/90 OSI interview; annotated transcript p. 84).

Dr. Popovic reportedly added another seven samples to the pool, most of which, contrary to Dr. Gallo's claims of high RT activity, had never even been tested for RT. Dr. Popovic himself described this as "Obviously ... more or less a blind experiment" (op. cit., p. 103).

Yet just two and a half weeks after Popovic's dramatic, last-ditch effort to save the "pool" culture, by Gallo/Popovic's own accounts, the "pool" culture was used to infect the eight "best-growing" clones of the HT (HUT-78) cell line, most notably H9. According to Gallo/Popovic, this cell line became the LTCB prototype HIV cell line, "H9/HTLV-IIIb," and on March 6, 1984, virus from this cell line reportedly was substituted for LAI/MOV as the source of the antigen in the LTCB HIV antibody blood test. Thereafter, according to Gallo/Popovic, this cell line became the centerpiece of the May 1984 Popovic et al. Science paper. But the LTCB laboratory notes and the Popovic et al., paper do not substantiate the reported progression of events concerning "HTLV-IIIb." In fact, the records, insofar as they exist, are remarkably ambiguous and confused, and thus, susceptible to many different constructions.

The designation "IIIb" does not appear anywhere in the Popovic et al., May 1984 Science paper, nor for that matter, in any of the Science papers published on the same occasion. Yet other isolates, e.g., "RF," "SN," "BK" are identified by a unique designation. Correspondingly, the experiment that allegedly resulted in the isolation of "IIIb" is described only in very general terms that might describe a "pool," but could equally well describe the culturing of individual isolates. In particular, there is no mention of a "pool," neither is the concept or rationale of pooling described in any manner whatsoever. It is noteworthy that the obscure description of the experiment that does that appear in the published paper was nowhere to be found in the paper when it first was drafted by Mikulas Popovic. In fact, the first approximation to the published version did not appear until draft #7 of Popovic et al.

The designation "IIIb" also does not appear in any LTCB laboratory notes before April 12, 1984. The designation "IIIb" does appear in the Gallo et al. blood test and cell line patent applications (submitted April 23, 1984), and it appears in records of Biotech Laboratories, the LTCB contractor that reportedly grew up IIIb in large quantities for transmittal to the Frederick Cancer Research Center, for mass production for an HIV-antibody blood test. But the only Biotech document substantiating the putative IIIb transfer to Frederick is a laboratory technician's calendar, containing an April 9, 1984 "IIIb" entry written over another entry that cannot be deciphered.

At the Frederick facility, laboratory notes record the sample that was received merely as "HTLV-III," the generic name Gallo et al. used for the AIDS virus, and not "IIIb," the alleged "pool" virus. Notably, according to testimony of both Biotech and Frederick scientists (Drs. Robert Ting and Larry Arthur, respectively), the alleged "IIIb" virus culture came close to dying shortly after it was shipped to Frederick, leading to a request to Biotech to supply more virus. Shortly after this request, according to Biotech records, Biotech shipped to Frederick a large quantity of LAI/MOV.

2. Chaos in LTCB "IIIb" Records:

The confusion in the LTCB records concerning the claimed existence and use of "IIIb" is reflected in Dr. Gallo's own OSI testimony. According to Dr. Gallo, the "pool" virus was given numerous other designations prior to the "IIIb" designation, including these: "HT/pool," "HTLV-A," "HTLV-AIDS," "HT/III," and "HTLV-III" (4/17/90 submission to OSI on "HTLV-IIIb; "Response to Question 3; Page 1.) There is no independent evidence to support the assertion that all these designations actually referred to the "pool" isolate.

In fact, there is considerable confusion about the meaning of "HTLV-A," and there are strong indications that Dr. Gallo used the term as a generic one to encompass all AIDS virus isolates, not to designate the "pool" isolate in particular. Dr. Gallo first used the term "HTLV-A" on March 5, 1984, in a letter to the editor of The Lancet. In this letter, Dr. Gallo referred to his "very very exciting patient serological results" with a suspected AIDS virus, and he said,

"We are debating whether to call them HTLV-III or HTLV-A (A=AIDS)" (emphasis added).

It was not until much later, in fact, as late as April 25, 1984, that Dr. Gallo finally made the decision to forego "HTLV-A" in favor of "HTLV-III" as a generic team to designate the AIDS virus. On April 25, Gallo wrote to Dr. Robert Downing of Wiltshire, England, stating that,

"I am now confident that HTLV-A is, in fact, the cause of AIDS."

Above "HTLV-A," Dr. Gallo wrote, by hand, "(HTLV-III)," with an asterisk to a footnote below, that read as follows:

"We decided to keep the trend of the previous nomenclature so it is HTLV-III."

Thus, there is consistent evidence that Gallo used "HTLV-A" as a generic term for the AIDS virus, and there isno evidenceto support Gallo's claim that "HTLV-A" referred uniquely to the "pool" isolate. Similarly, Dr. Popovic also used the term "HTLV-A," in the first draft of the Popovic et al. paper, to describe the isolate that was featured in Figure 2A of the paper. In subsequent drafts, "HTLV-A" was struck out and replaced with "HTLV-III."

As if this were not confusing enough, there is also the curious matter of "HTLV-IIIA," a designation used for both the putative pool virus and MOV. Dr. Gallo mentioned the "IIIA" designation in his book Virus Hunting, where he said of HTLV-IIIb that,

"... the 'b' simply stood for the fact that the sample [the putative "pool" sample] was split into portions, A and B" (page 181).

In an OSI interview, Dr. Gallo gave a somewhat different account. Referring to Dr. Popovic's work with the "pool" virus, Dr. Gallo said, "HTLV-IIIA" "... is probably the other part of the pool." Responding to a question about what he meant by "the other part of the pool," Dr. Gallo said this: "He had aliquots. He had two aliquots. One aliquot was 'A' and one was 'B' that he used to infect different clones of HT. It turned out that clones of the 'B' went into H9. H9 was better. So arbitrarily 'B' became the producer" (4/26/90 interview; transcript page 114). Responding to a question about what happened to "HTLV-IIIA," Dr. Gallo said,

"Well, 'A' wasn't as good. He just didn't continue with it. The clones that 'A' was used -- 'A' was used ... to infect ... those clones didn't do as well as H9 did, and so H9 was chosen and H9 happened to be this hand instead of this hand, and he called it 'B' as opposed to 'A'" (op cit., page 114).

In a subsequent interview, Dr. Gallo said that:

"HTLV-A or HTLV-AIDS are early designations for virus from the pool, later named HTLV-IIIa and HTLV-IIIb. B was the one that grew best in H9 eventually and became more standardized" (7/25/90 OSI interview; transcript p. 4).

These statements by Dr. Gallo are discrepant with the evidence. Dr. Gallo's claim that "IIIa" did not produce well and was discontinued does not square with the fact that "H4/HTLV-IIIA" was given out to other scientists, e.g., Dr. Robin Weiss, at least as late as the Spring of 1984. Moreover, "HTLV-IIIa" as well as IIIb was specifically cited in a Gallo et al., CIP patent application, submitted in August 1984. This application said that:

"... a DNA fusion has led to the conclusion that there are at least two definite fractions to the HTLV-III, namely HTLV-IIIA and -IIIB, particularly susceptible to use by the present assay test kit procedure of the present invention" (Application for United States Patent: "Method and products of immunological test kits useful in assaying retroviruses such as HTLV-III," Serial Number 643,715, page 2).

Subsequently, in November 1985, additional claims were incorporated into the "715" patent application, including two claims specifically citing use of "HTLV-IIIA." In short, contrary to Dr. Gallo's claims to OSI, all indications are that "HTLV-IIIA," whatever it was, was not discontinued.

Moreover, evidence from several different sources indicates that "HTLV-IIIa," which Dr. Gallo repeatedly said was part of "the pool," and "MOV," the allegedly independent isolate, were one and the same isolate. Provocative testimony and evidence were obtained from Biotech Laboratories, the LTCB contract laboratory that received samples labelled "MOV" and "HTLV-IIIa" and "IIIb" for large-scale production. Dr. Robert Ting, the founder and former President of Biotech, also the scientist who personally initiated the large-scale production of "IIIb" at Biotech, told the OSI that,

"... in later freeze cultures (at Biotech) we call H9/MOV is HTLV-IIIa" (2/21/91 OSI interview; transcript page 9).

In response to a follow-up question, Dr. Ting reiterated his information:

"... in our lab we call HTLV-IIIa so when we tell the technician to grow HTLV-III, which do you want to grow, 'a' or 'b.'"

Asked if "HTLV-IIIa" was "MOV," Dr. Ting responded "yes."

Dr. Mark Manak, in 1991 the Senior Vice President at Biotech, confirmed Dr. Ting's testimony. Dr. Manak told OSI, in a June 24, 1991 letter, that,

"The samples we received from Dr. Gallo's lab were labeled MO(V) and we retained that designation in our records. Our understanding was that this represented a culture of HTLV-IIIA in H4 cells." Dr. Manak further said that, "Our understanding was that HTLV-IIIA and HTLV-IIIB were different cultures and were to be handled separately."

The Biotech laboratory records confirm the nomenclature described by Drs. Ting and Manak. A Biotech freezer log entry identified "MOV," frozen 2/29/84, as "= (H4/HTLV-IIIA)." A separate entry in the freezer log was identified as "HTLV-IIIA," said to have been frozen 3/28/84. Dr. Manak told OSI that both the 2/29/84 and 3/28/84 freezes were HTLV-IIIa cultures, with the latter "... possibly in different host cells" (June 24, 1991 letter to OSI).

And in 1994, Dr. Ting provided even more definitive evidence concerning the identity of MOV and "HTLV-IIIA." In a June 13, 1994 letter to Dr. Gallo, elicited by Dr. Gallo when NCI Director Dr. Samuel Broder required him to provide evidence about the origins of MOV,
Dr. Ting said this:

"... I received MOV about a month before I received HTLV-III. Later LTCB designated HTLV-III as HTLV-IIIB. At the time of cryopreserving HTLV-III, I have told the technician to footnote in her log book MOV = HTLV-IIIA to distinguish it from HTLV-III."

Finally, there is evidence originating with LTCB scientist Dr. Suresh Arya showing that Dr. Arya believed "HTLV-IIIa" was another name for the isolate previously named "MOV." In September 1986, at the height of the blood test patent dispute, Dr. Arya prepared a list of 1984 entries from his laboratory notes in which he received samples and labelled them as "LAV."

(Dr. Arya claimed to OSI, as did Dr. Gallo to the United States Government attorneys, that he never worked with the actual LAV isolate from Institut Pasteur, and used the term "LAV" generically to designate the AIDS virus. However, there is at least one notebook page, not provided to OSI, that shows Dr. Arya, on May 6, 1984, was working with "LAV cDNA [Paris]." Dr. Arya confirmed to Subcommittee staff that this notebook page was his, but he claimed he did not remember the experiment. Dr. Arya also said he did not know why the notebook page was not provided to OSI. The Subcommittee staff was not able to obtain any additional information concerning this matter.)

Particularly relevant to the present discussion is this entry from the September 1986 Arya list:

"Notation on June 28 -- Mika if LAV (MOV) should be HTLV-IIIA; on Aug 8 - Mika, if cells should be HT cells infected with HTLV-IIIA/MOV."

The above entry, along with numerous other entries, was deleted from Dr. Arya's list before it was provided to OSI.

The fact is that, at best, the designations "MOV," "HTLV-IIIA," and "IIIB" were hopelessly confused in the laboratory notes at the LTCB. In many instances, these terms were used interchangeably. These circumstances cast significant doubt on the claim that MOV and the "pool" isolate were genetically distinct. The Roche Laboratories revelation that both "IIIb" and "MOV" are the IP virus LAI conclusively refutes the claim.

C. Subsequent Claims by Gallo/Popovic about Their "Breakthrough" Discoveries

During the French/American dispute, Drs. Gallo and Popovic made a number of significant claims about their "breakthrough" discoveries in AIDS research, many of which appeared in the popular and scientific media, as well as (in Gallo's case) in legal briefs filed on behalf of the U.S. Government, which erroneously dated the LTCB discoveries to late 1983, were incorrect and significantly incomplete, and thus, were significantly misleading.

The incorrect claims concerning the "discovery" of H9 have already been discussed. Other incorrect claims concerned when Gallo/Popovic "isolated" HTLV-IIIb, the "pool" virus, and when the LTCB HIV antibody blood test was developed. Claims such as these appeared in, for example, the same November 1985 article in Science magazine, previously cited, reportedly based on interviews with Gallo and Popovic, and containing their unqualified assertions that they were not able to grow LAV. According to the article, when Dr. Gallo realized that the new retrovirus he had detected was,

"... killing the cells it infected, he began to look for cells that would resist its cytopathic effects. He found what he was looking for in early November."

The article went on to say that:

"Popovic discovered that clones developed from a line of T cells established from a leukemia patient could be infected with virus from the cells of AIDS patients and go on producing virus indefinitely ... Because virus from some patients appeared to infect the cell line more readily than others, Popovic ... pooled virus isolates from 10 patients and used the mixture to infect the cells. By December,, Gallo's lab was mass-producing virus from a cell line, called H9, infected with virus from the pooled samples" (emphasis added; Science, 230, November 1985, Page 521).

The November 1985Sciencearticle continued:

"This breakthrough enabled Gallo's group to characterize the virus ... Equally important, mass production of the virus opened the way for development of a sensitive test ... to detect antibodies to the virus in blood samples. The test nailed down, to almost everybody's satisfaction, that the virus was the cause of AIDS."

The article then quoted Dr. Gallo directly:

"'The data poured in in December and by January we had solved the problem [of the cause of AIDS],' says Gallo" (emphasis added; op cit., Page 521).

The evidence presented in this report shows that these claims were not true. Gallo et al. were not "mass-producing" H9/HTLV-IIIb by December; neither the H9 cell line nor the putative IIIb isolate even existed by that time. Nor did the data "pour in" in December -- the LTCB blood test was not even reliably adjusted until late-January, and it was not used for definitive serology on blind samples until late-February. Moreover, what was not revealed by Dr. Gallo was the fact that the only isolate in large-scale production before late-January 1984 was LAI/MOV/, andallthe serology prior to March 1984 was based on MOV.

That the untrue statements attributed to Gallo/Popovic by Science magazine were not "misquotes" or due to some other journalistic failing is seen in the fact that Dr. Gallo repeated the same claims again and again, always moving events that occurred well into 1984 back to the Fall of 1983, always implying that key experiments were performed with LAI/IIIb, when most actually were performed with the mystery isolate, "MOV," always exaggerating his understanding of the significance of the data at the time they were actually obtained.

o Dr. Gallo claimed, at the April 1984 HHS press conference that he had been "mass-producing" the AIDS virus for six months. Further, he said, "I was developing reagents over that period of time to go back and do the analyses." This claim would date the beginning of "mass production" at the LTCB to late October. But the only AIDS virus isolate Gallo, et al., even had in a permanent cell line six months prior to the press conference was LAI/LAV, the isolate Dr. Gallo said for years he could not grow. Moreover, even LAI/LAV was not "mass produced" for six months prior to the news conference, and it was not until December 1983, two months later, that LAI under the name, "MOV" was produced in anything even approaching large quantities.

o Dr. Gallo told a February 1985 meeting of the NCI Division of Cancer Treatment (DCT) Board of Scientific Counselors that an HIV blood test "was ready in December 1983" in his laboratory.

o As late as November 1986, Dr. Gallo was repeating the same claims, this time to a meeting of scientists at the Royal Postgraduate Medical School in London. According to New Scientist:

"Gallo says that by the end of December 1983, he had enough virus to show that AIDS patients had antibodies to it" (February 12, 1987, p. 54).

Concerning the meeting in London,New Scientistreported this:

"... Gallo said that the results of his test at this time (December 1983) were 'unambiguous evidence that this [virus] and this alone was the cause of AIDS'" (op cit., p. 54).

D. The "CDC Data"

During the first half of 1984, Gallo et al. continued to refine their HIV antibody ELISA test. The ELISA tests developed by the IP and LTCB became the first-stage (screening) tests employed by blood banks world-wide. Dr. Gallo had known since at least the previous autumn about the IP blood test. In mid-March 1984, Dr. Gallo obtained important information about the performance of the LTCB test and about the IP test as well. The information came from the Centers for Disease Control (CDC) scientist, Dr. James Curran. Dr. Curran had previously sent Dr. Gallo a panel of over 200 sera for blind testing with the LTCB HIV antibody blood test. On March 12, 1984, Dr. Curran met with Dr. Gallo and his colleague Dr. Sarngadharan to "break the code" to determine how accurate the LTCB test was in detecting antibodies to the suspected AIDS virus.

Dr. Gallo frequently recounted the meeting with Dr. Curran, asserting that Curran told him the LTCB results were "clear-cut" and that, in Curran's view, Gallo and his colleagues "had determined the cause of AIDS" (4/30/86 Gallo "History of Key Events ..."; 11/8/86 Gallo sworn declaration).

But Dr. Gallo's accounts of the meeting with Dr. Curran were highly selective. What Dr. Gallo invariably failed to say is that the LTCB test scored only 48 percent positive in AIDS patients in the CDC tally. (Handwritten tallies by Dr. Curran and another scientist, dated contemporaneously with the meeting, confirm this figure.) Several subsequent tests by Gallo et al. of other large serum panels were no more impressive, e.g., in May 1984 and June 1984, the LTCB test scored only 40 percent and 47 percent positive in sera panels provided by Drs. David Ho and Bijan Safai, respectively (the latter data were published in The Lancet in June 1984 -- see below).

Since the HIV blood test was in its developmental stages, these low figures would not be particularly remarkable, were it not for the fact that on numerous occasions, the United States Government and Dr. Gallo himself criticized the IP test for its early AIDS detection rates in the 40 percent range, e.g., "... serum samples from 37.5 percent of patients with AIDS were found to react with it [LAV]" (Popovic et al., Science, 224, 1984, p. 500); "Even in July 1984, the LAV- containing test systems picked up only 41% of AIDS patients" (Fischinger-to-Harmison memorandum; August 27, 1985, p. 9); and "... as late as July 1984, Montagnier reported only about 40 percent positives with his composition" (Submission of Motions by Gallo et al., October 1986, p. 4.)

It also bears mention that Dr. Gallo invariably cited the June 1984 Safai et al. paper (The Lancet, 1984, pp. 1438-1440) as an instance of 100 percent accuracy of the LTCB blood test. But this figure was achieved only by combining both the LTCB ELISA and Western Blot (a confirmatory test), using the latter test to assay all samples negative by ELISA, a practice directly opposite the practice in blood screening clinics, where ELISA+, not ELISA- samples are subjected to confirmatory testing.

Even more important, what Dr. Gallo invariably failed to reveal about the meeting with Dr. Curran is that Curran told him CDC had sent many of the same sera tested by Gallo et al. to the IP scientists, for testing with their LAV antibody blood test. The IP blood test scored as good or better than the LTCB blood test, and according to Dr. Curran's testimony to GAO investigators, he told Gallo about the concordance of his results with those of the IP, during the March 1984 meeting.

Dr. Gallo told Subcommittee staff he did not recall being told by Dr. Curran about the IP blood test results, yet just a few weeks after the Gallo/Curran meeting, while lecturing in Zurich, Dr. Gallo said this about the work of the IP scientists:

"... I have heard recently that their serological data has gotten very good, almost as good as I know we have with these" (Symposium on Infective Agents and Their Effects - New Perspectives; Beecham Research Laboratories, April 5, 1984, audiotaped address).

Dr. Gallo confirmed to Subcommittee staff that he made the above remarks, but he claimed he could not recollect the basis for them, other than "rumors via the grapevine."

The day after the Beecham symposium, an even more significant event relating to Dr. Gallo's knowledge about the IP LAV antibody blood test, took place. On April 6 at the Institut Pasteur in Paris, Dr. Gallo was shown the CDC computer print-out containing a side-by-side tabulation of the LTCB and IP blood test data. Five other scientists who were present in the room (including two scientists from the United States: Drs. Donald Francis and Murray Gardner) substantiate these events, particularly, that: (a) Dr. Gallo saw the data; (b) the data showed convincingly that the IP and LTCB viruses were both associated with AIDS; and (c) the IP blood test was equal to or better than the LTCB test in detecting antibodies to the suspected AIDS virus.

Dr. Gallo revealed nothing about the CDC data to the PTO, nor even to the attorneys who prepared the LTCB patent applications, the lawyers who told Subcommittee staff they instructed Gallo and his colleagues concerning their duty of candor and disclosure. Neither did Gallo et al. cite any information about the CDC data or its implications in the May 1984 Science papers, submitted just six days before Gallo saw the data, and by Gallo's own account to OSI, "updated" to the time the galley proofs were reviewed. Instead, in the Science papers, Dr. Gallo cited IP blood test data from the Summer and Fall of 1983, and he contrasted these data with data for his own test from months later, i.e., from the Spring of 1984.

Dr. Gallo for years denied his knowledge of the CDC data, and he denied the data's significance; yet in so doing, Dr. Gallo revealed much about his actual knowledge of the data and his understanding of their significance. In OSI interviews, Dr. Gallo made these kinds of statements about what he saw during the April 1984 meeting at the Institut Pasteur:

"I saw nothing. I sat where I am and they were working on a corner of a circled table but I didn't know why Don Francis was there. He said, 'oh you know, the results were quite comparable in the blind comparative test. I was saying, 'I am going to get right sucked into this. They are going to -- I said, ' look I am not publishing CDC data sera. We have our own publications planned and gone off already. I was getting worried that they were going -- this is what was happening.

I was thinking to myself, what the heck is Don doing here? But I never had a chance to review this data ...

I repeat again, I saw that data from six feet away for two milliseconds. I saw no real numbers" (7/27/90 OSI interview; transcript pp. 95-97).

"...in that meeting, I never saw the data" (8/3/90 OSI interview; transcript p. 225).

"...I knew there was no data from Pasteur or CDC. I mean, I knew it well because I had just been there. I mean, what data was new? There was no new data. It was very little and it wasn't going to be published for another six or seven months" (12/2/90 OSI interview; transcript pp. 79-80).

(The above passages illustrate well Dr. Gallo's longstanding, deep-seated antipathy toward the CDC as an institution and particularly toward Dr. Donald Francis, who on a number of occasions spoke out strongly concerning Dr. Gallo's conduct.)

Another prime example of Dr. Gallo's denials relating to the CDC data is a December 17, 1991 memorandum Gallo wrote "To the record," titled "Blood Test Patent and Related Information." The memorandum was meant for a top-level audience at the NIH; copies were noted to Drs. Samuel Broder and Bernadine Healy, Directors of the NCI and NIH, respectively, as well as to the NIH Legal Advisor, Robert Lanman, and Thomas Mays, Director of the NCI Office of Technology Development.

In the December 1991 memorandum, Dr. Gallo said he had:

"... learned of rumors ... [of] still another 'new' argument being made against me, NIH, the patent and the Agreement .... that I 'knew' and reviewed data 'from Pasteur scientists' in early April 1984 (about two weeks before submitting our patent application), which showed that 'their' blood test was about as good as ours."

Said Gallo, "This is a big misrepresentation of the facts."

Yet, just three months later, in a recorded telephone message left on the answering machine of Dr. Donald Francis, the CDC scientist who showed him the computer print-out on April 6, 1984, Dr. Gallo said this:

"I'm well aware of the serology data that you gave for me to look over on one occasion during the visit to Pasteur. I am aware of that happening."

When he was interviewed by Subcommittee staff in July 1993, Dr. Gallo said the CDC "had no credibility." He also said that he did not trust the results of the IP blood test because the IP scientists had changed the cut-off score for its test. Dr. Gallo told Subcommittee staff, "You just can't draw the cut-off where you want." In fact, adjustment of cut-off scores is regularly done when a test is in the developmental stages; it is a normal part of the process of maximizing a test's sensitivity and specificity. Gallo et al. adjusted the scoring of their own LTCB blood test on the CDC panel of sera, changing "+/-" scores to "+." This was what resulted in the LTCB test's jumping from 48% to 80% positive in persons diagnosed with AIDS.

Notwithstanding Dr. Gallo's denigration of the CDC data, the fact is that HHS itself regarded the data as definitive, and believed the data showed that LAV and the LTCB virus were both the cause of AIDS. The official HHS position on the matter was rendered by Dr. Robert Windom, then-Assistant Secretary for Health and Mr. Ronald Robertson, then HHS General Counsel, in an April 1988 letter to a German publisher: Concerning the CDC data, Windom and Robertson said this:

"... in early 1984, under the auspices of the Centers for Disease Control in Atlanta, Georgia, a series of blind tests was undertaken to ascertain whether the sera from patients with AIDS contained antibodies to HIV. Of significance is the fact that both NCI and Pasteur participated in these tests. Each laboratory was provided with sera and asked to judge whether each specimen contained antibodies to the virus. The results of those tests unequivocally established that HTLV-III/LAV was the presumptive causative agent of AIDS" (p. 3).

To this day, Dr. Gallo continues to maintain that at the time the CDC data were obtained, the IP scientists "did not have a blood test."

E. Functional Identity of LAV and "HTLV-III"

Based on the LTCB's own work with LAV and the viruses Gallo et al. collectively called "HTLV-III," as well as the work of the IP scientists with LAV, Gallo et al., as early as February/March 1984, had strong presumptive evidence that LAV was -- at least -- the same kind of virus as the LTCB's own putative AIDS virus isolates. This functional identity was important scientifically as well as clinically, and it was important legally, relative to the patent applications of Gallo et al.

The LTCB scientists subjected LAV to the same battery of tests as they used on their own samples. They obtained the same results with LAV as they obtained with what they claimed were genuine LTCB HIV isolates (see above). Dr. Gallo told OSI that prior to the publication of the May 1984 Science papers, the LTCB's own data revealed that HTLV-III and LAV "were of the same virus type ..." (4/17/90 written submission to OSI). Dr. Gallo also said that:

"... the same virus type was suspected, I would say, by ... the early part of 1984, certainly before the press conference" (4/11/90 OSI interview; transcript p. 62).

Dr. Gallo's utterances from March/April 1984 confirm these statements to OSI. In March 1984, in an audiotaped lecture, Dr. Gallo asserted that his "HTLV-III" virus was "very similar" to the Pasteur virus (3/17/84 address at the Association pour la Recherche sur le Cancer; Marseilles, France).

Dr. Gallo also made repeated, strong assertions to OSI concerning what he told the Pasteur scientists, during his trip to the IP in the first week of Aril 1984, concerning the likelihood that LAV and "HTLV-III" were the same virus type. Among these many assertions, the following are representative:

"I concluded my seminar by saying 'this is the virus that they isolated last year. It is the cause of AIDS ..." (4/8/90 OSI interview; p. 12).

"Remember, when I lectured in Paris I said it. I said this is like the cause of AIDS. We've made a blood test for it. I believe it's what they'd published last year" (4/11/90 OSI interview; transcript p. 62).

"... I said that, 'this is the cause of AIDS and I believe these guys found it last year and it's the same virus that they found.' There was no bones about it. I mean it wasn't a pulled punch" (op cit., p. 63).

"... I said that publicly. I said it in the conference. It said it in front of 500 people from the Pasteur Institute or from all Paris. I closed my final presentation with a slide of a picture of viruses and I said I believe this is the cause of AIDS. I believe they found it last year. I believe we are going to prove it very shortly" (7/27/90 OSI interview; transcript p. 85).

Yet, in direct contradiction of these self-described beliefs, shortly before he travelled to Europe, Dr. Gallo edited Dr. Popovic'sSciencemanuscript in such a manner as to delete all references to the functional identity of LAV and HTLV-III (see below), at the same time adding to the paper the false claim that LAV had not been transmitted to a permanent cell line, plus the assertion that,

"... HTLV-III and LAV may be different."

Later, during the blood test patent dispute, in an attempt to defend the United States blood test patent, particularly the U.S. scientists' failure to disclose the prior art of the IP scientists, the U.S. Government attempted to argue that there was no need to disclose the IP scientists' work because, at the time of submission of the U.S. patent application, there was no reason to believe the IP and LTCB viruses were even the same kind of virus. Pursuant to this argument, Dr. Gallo asserted, under penalty of criminal prosecution for making false statements, the following:

"At the time the Gallo patent was filed [April 1984], my colleagues and I did not consider LAV and HTLV-III to be the same or even substantially the same, virus. Quite clearly the data available to us indicated that the two viruses functioned differently and reacted differently" (11/8/86 Gallo declaration; p. 13).

Dr. Gallo has attempted to justify these claims by invoking IP experimental results that Gallo says were described to him by Drs. Montagnier and Chermann. One example cited with great frequency by Dr. Gallo is the IP scientists' reported assertion that they did not see the envelope protein gp41 in their preparations of "LAV," whereas the LTCB scientists identified gp41 as "one of the major proteins of the virus" (Sarngadharan et al.,Science,224,1984, p. 508).

There are a number of significant problems with Dr. Gallo's claim that prior to the April 1984 submission of the Gallo et al. blood test patent application and the May 4 publication of the Popovic et al. paper, he had reason to believe the IP scientists had not seen gp41 in their virus. Chief among these problems is the lack of substantiating evidence. The only pre-May 1984 IP reference that Dr. Gallo cited to support his claim -- the Montagnier et al. paper presented in September 1983 at Cold Spring Harbor -- indicates the IP scientists had identified a protein around the size of gp41 in their virus. According to the IP paper,

"A 36K protein, a 42K protein, and an 80K protein were constantly found to be associated with the purified virus and may represent the major envelope proteins" (Montagnier et al., Human T-cell Leukemia/Lymphoma Viruses, 1985; p. 369).

Dr. Gallo also has frequently invoked a chart prepared by Drs. Montagnier and Sarngadharan in May 1984 ("Status of the comparison ...") as evidence of the IP scientists' failure to see gp41. In fact, Dr. Gallo has frequently carried the argument further, asserting that the chart shows that Dr. Montagnier himself was arguing for real differences between the IP and LTCB viruses. Thus, in his April 1986 "History of Key Events ..." -- widely distributed among HHS administrators and attorneys -- Dr. Gallo said this:

"June 1984: M. Sarngadharan, a close co-worker of Gallo, goes to Paris, brings the cell line producing HTLV-III and with Montagnier makes comparisons of LAV, to our prototype HTLV-III known as the B strain (HTLV-IIIb). They prepare a table signed by Montagnier in which Montagnier argues for significant differences between HTLV-IIIb and LAV" (emphasis in original; p. 5).

Dr. Gallo made the same kinds of statements, repeatedly, to OSI. A representative example is the following:

"When Sarang visited Montagnier in May 1984, and brought IIIb there and did some work together with Montagnier, Montagnier insisted on differences between LAV and IIIb. I have some of this in writing. For instance, Montagnier said that LAV did not have the major envelope transmembrane component, gp 41" (4/8/90 OSI interview; transcript p. 35).

But Dr. Gallo's claims about Dr. Montagnier's position on gp41, as of May 1984, cannot be substantiated. The chart completed by Drs. Sarngadharan and Montagnier actually shows, in the "agree" column relating to the p41-43 proteins, that the scientists agreed, "... there is an actin band in viral preparations." In the "disagree" column, the notations in the chart show that Dr. Sarngadharan said gp41 is "... likely to be viral origin (gp),is recognized by most AIDS patients by Western blotting," while Dr. Montagnier said gp41, "is not seen after labelling." However, importantly, it is clear that Sarngadharan and Montagnier did not consider the matter as resolved, because in the "decide" column of the chart there appeared a number of "things we have decided to do." These entries included Dr. Montagnier's further examining his virus, using "exactly technique of Western blotting of M.S. [Dr. Sarngadharan] who will send it as soon as possible to L.M. [Dr. Montagnier]."

Notably, according to the chart, Dr. Sarngadharan also committed to send Dr. Montagnier, "the uninfected H9 cells for this purpose." But as described below, H9 was not sent to the IP scientists until the Fall of 1984, and then only after repeated requests by them to Dr. Gallo (see below).

The above passages show that as of May 20, 1984 (the date on which the Sarngadharan/Montagnier chart was prepared), the presence or absence of gp41 in the IP virus was very much an open question, with a significant amount of experimentation remaining to be done. Shortly thereafter, the presence of identical envelope proteins in both LAV and "HTLV.III" was confirmed, both at the IP and LTCB, indicating the earlier failure of the IP scientists to see gp41 was due to technological deficiencies (see below for additional information on this point).

As an experienced scientist, Dr. Gallo knew well that the putative gp41 differences between the IP and LTCB viruses, as well as other putative differences Gallo said the IP scientists described to him (e.g., their reported inability to raise rabbit antibodies to their virus), could very well be due to methodological problems, as indeed, they were shown to be. Thus, the invocation of the early IP data as indicative of real, fundamental differences between the IP and LTCB viruses was both factually wrong and scientifically highly suspect.

Moreover, Dr. Gallo's invocation of these data, as in his declaration, ignored the substantial quantities of data -- both from the IP and the LTCB -- that indicated the viruses were functionally the same. These were the data that showed Dr. Gallo, by his own account, that the viruses "were of the same virus type." They were the data that led Dr. Gallo, by his own account, to proclaim in Paris in April 1984, concerning the LTCB virus, that, "... these guys found it last year and it's the same virus that they found." Thus, the claim in Dr. Gallo's declaration that "the data available to us" showed that the viruses "functioned differently and reacted differently" is significantly incorrect and incomplete, and is contradicted by his own words.

Dr. Gallo has stated that it was the HHS attorneys who advised him that the IP and LTCB viruses were "substantially" different, and that it was on the basis of this advice that he signed his declaration. But Dr. Gallo also told Subcommittee staff he wishes he had said in the Popovic et al. paper that, "LAV and HTLV-III are probably the same," rather than "may be different." Concerning his sworn declaration, Dr. Gallo told Subcommittee staff that the denial in his declaration that he and his colleagues knew LAV and HTLV-III were substantially the same was "not accurate." Dr. Gallo added this:

"I wish I hadn't signed it [the declaration]. I'm not proud of that."

F. The Popovic et al. Science Paper

On May 4, 1984, the LTCB scientists published four papers in the journal Science, announcing their putative isolation of HIV and development of an antibody blood test. One of the LTCB papers, by Popovic et al., described the "continuous production" of HIV in the "HT" cloned cell lines (see below). Important as the paper was, there were numerous problems with its accuracy and completeness. In addition to the false statements concerning the IP virus, the Popovic et al paper contained numerous incorrect statements and misrepresentations of data. Dr. Popovic was found guilty of scientific misconduct by ORI, based on his responsibility for false statements in the paper. The HHS Appeals Board reversed this finding, based on its own curious definition of scientific integrity, plus its own unique determination that falsification of data is not de facto scientific misconduct. The demonstrable falsehoods in the paper remain unchallenged.

The preparation of the Popovic et al. paper was itself remarkable, embodying the elements of an extraordinary conflict within LTCB that would ultimately become public, a conflict between Drs. Gallo and Popovic that was in reality a conflict between the truth and a fiction about the LTCB scientists' use of LAV, and the knowledge that resulted from that use.

Dr. Popovic was the LTCB scientist who worked most closely with the IP virus and the LTCB's putative prototype isolates, LAI/MOV and LAI/IIIb. Based on his work, Dr. Popovic was so certain of the functional identity of LAV and HTLV-III that, in the first draft of his Science paper he wrote, concerning his own experiments, that "LAV as a reference virus ... had been used in the first series of experiments," and "LAV is described here as HTLV-III."

Dr. Gallo struck out both of these statements, writing in the margins of the paper,

"I just don't believe it. You are absolutely incredible"

and

"Mika you are crazy."

Dr. Gallo then added to the conclusion of the paper his rendition of a few highly selective pieces of data (tellingly, Dr. Gallo listed these items on the cover of the manuscript under the heading, "Way to deal with this LAV originally").

Dr. Gallo also wrote, in the conclusion of the paper this passage:

"These findings suggest that HTLV-III and LAV may be different. However, it is possible that this is due to insufficient characterization of LAV because the virus has not yet been transmitted to a permanently growing cell line for true isolation and therefore has been difficult to obtain in quantity" (Popovic et al., Science, 224, p. 500).

This passage contains several notable assertions, including the following:

o The suggestion that "HTLV-III and LAV may be different" -- when the LTCB's own data and chief scientist were saying precisely the opposite and Dr. Gallo himself had publicly proclaimed the viruses were likely to be the same;

o The assertion that LAV had been "insufficiently characterized," when in reality, in addition to the LTCB scientists' own work, the IP scientists had presented and published many papers on the characterization of the virus. Dr. Gallo was present for several of the IP scientists' talks and he received several of their papers well in advance of their publication. The IP papers and presentations included the September 1983 Cold Spring Harbor presentation by Dr. Montagnier (described above); the November 1983 Tokyo presentation by Dr. Barre-Sinoussi (described above); the New York Academy of Sciences presentation concerning the effects of LAV on T-cells; the February 1984 presentation by Dr. Chermann at Park City, Utah, titled "Characterization and Possible Role in AIDS of a New Human T-Lymphotropic Retrovirus"; a highly significant paper by Vilmer et al., containing the first published description of the methodology for the LAV ELISA (The Lancet; April 7, 1984, p. 753); and Montagnier et al. (Annals of Virology, 135E; April 1984, p. 119) on the "further characterization of LAV."

o The assertion that LAV had not been transmitted to a permanently-growing cell line, when both the LTCB and the IP scientists, months earlier, had attained this accomplishment, and Dr. Gallo knew this was so. Dr. Montagnier told OSI he informed Dr. Gallo he (Montagnier) was growing LAV in an EBV-transformed B-cell line, well before the publication of the Popovic et al. Science paper. Moreover, it is certain that Dr. Gallo knew that Dr. Popovic had grown the IP virus in a permanent cell line. In the fourth draft of the paper, in his own hand, Dr. Gallo wrote this:

"Finally, a T-lymphotrophic retrovirus different from HTLV-I and II and associated with lymphadenopathy syndrome was detected earlier ... We found that this virus, called LAV (provided by L. Montagnier and J.C. Chermann) also grows in H4 and produces similar cytopathic effects on it as HTLV-III."

Dr. Gallo deleted the latter statement from the published version of the paper. Dr. Gallo also significantly rewrote the Popovic et al. paper so that it would indicate Dr. Popovic's initial experiments were performed with the LTCB prototype isolate, rather than with LAV. These changes were made over Dr. Popovic's strong objections (see below).

(Dr. Gallo's principal defense of the published statements relating to the IP virus in the Popovic et al. paper is that he [Gallo] was referring only to the IP scientists' work, not work at the LTCB. This claim is belied by numerous pieces of evidence, not least of which is the content and structure of the statement itself which manifestly is not qualified in any way, but is a blanket assertion that the IP virus, "has not been transmitted to a permanent growing cell line." Additional evidence that Dr. Gallo intended to make a general and not a limited statement about the growth of LAV is seen in drafts of the Popovic et al. paper. As noted above, drafts of the paper bearing Dr. Gallo's own handwriting show that prior versions of the "LAV" passage included statements about both laboratories' work with the IP virus, not just the work of the IP scientists themselves. Notably, prior versions of the passage contained the phrase, "poor virus production," rather than the phrase "not yet been transmitted to a permanently growing cell line." The latter phrase must have been substituted -- literally -- at the last minute; it does not appear even in the galley proofs of the paper.

Finally, even if the published statement had been explicitly limited to the IP scientists work, it still would not be true. Dr. Gallo had known since at least the first week of April 1984 that the IP scientists were growing their virus in a permanent cell line. Dr. Gallo actually mentioned the IP scientists' accomplishment at the HHS press conference, although he misrepresented and minimized its significance by the assertion that,

"They believe they're getting it into a cell line just now" [press conference transcript p. 31]).

Dr. Popovic secured the drafts of the paper that bore Dr. Gallo's notations with his (Popovic's) sister in Czechoslovakia, because, Dr. Popovic said, he believed that:

"... sometime in the future, I might need them as evidence to prove that I gave fair credit ..." to the Pasteur scientists (5/15/91 Popovic-to-Hadley memorandum; p. 7).

Dr. Popovic produced the drafts of his paper late in the OSI investigation, when he believed he was likely to be found guilty of scientific misconduct and he hoped the drafts, by revealing the significant involvement of others in the writing of the paper, would be exculpatory to him.

Dr. Popovic also repeatedly recounted to OSI the disagreement he had with Dr. Gallo concerning Gallo's deletion from the paper of his (Popovic's) description of his LAV experiments. Of this matter, Dr. Popovic said,

"... I would consider (it) a major disagreement" (4/10/91 OSI interview; transcript p. 6).

Among Popovic's statements to OSI, reflecting the strength of his (Popovic's) views on the matter, the following are exemplary:

"I thought that we should include the LAV data in the paper ... LAV data what we had with the French virus. I think was right because this my paper is suspicious because of those LAV data are not included. Retrospectively it is very obvious it would be better" (12/1/90 interview; transcript p. 103).

"Regarding my opinion, I told him if in those time and I am telling it now that it would be better to refer to the French work and present the LAV data what we had, that has been my opinion all along ... and I expressed this" (op cit., p. 156).

"I did not agree with Dr. Gallo that the references to the work we did with the French virus should be omitted or even significantly minimized ... I thought it was wrong not to credit Dr. Montagnier's group's contributions more clearly" (4/10/91 OSI interview; transcript pp. 7-8).

In Dr. Gallo's account, what Dr. Popovic called a "major disagreement" became "a very brief discussion." Here is what Dr. Gallo said to OSI (prior to Dr. Popovic's revelation of the draft manuscripts):

"... there wasn't much emphasis. I think, Mika thought maybe we should make a statement to the effect that LAV was in culture ... don't think that Mika argued forcefully or strongly that we have to have some data on LAV growing in culture. That is not the case. He did mention it in an almost casual way, maybe we should put a statement in that at least for the time being with partial characterization" (12/2/90 OSI interview; transcript pp. 184-186).

According to Dr. Popovic, one of the reasons he acceded to the removal from his paper of the account of his LAV experiments was Dr. Gallo's assurance that this information would be included in the collaborative papers that were soon to be produced with the IP. As described below (seebelow), three such papers were produced; however, none of the papers was ever published. Moreover, none of the collaborative papers made any mention of the LTCB's growth and extensive use of the IP virus they received in 1983; thus, this vitally important aspect of the LTCB scientists' work -- until the French/American dispute -- was suppressed.

G. Selection of the Isolate for the LTCB HIV Blood Test

1. The Gallo/Popovic debate:

The question of which isolate the LTCB scientists would use as the antigen for their HIV antibody blood test became critical at the point at which the LTCB patent applications were prepared, during the first three weeks of April 1984. As previously described, none of the four May 1984 LTCB papers mentioned an isolate called "IIIb," including the paper by Sarngadharan et al. that described the LTCB blood test. But for purposes of the patent applications, greater specificity was essential.

Clearly, an explicit acknowledgement that LAI/LAV was used for the LTCB blood test would not do, since such use would have violated the noncommercialization agreement signed by Dr. Popovic when he received the IP virus the previous Fall. Acknowledgement of the use of MOV also would not do, since the LTCB scientists -- if their own account is to be believed -- did not know its origins, even if it had come from an AIDS or pre-AIDS patient. So Dr. Gallo and Popovic had to decide which putative LTCB isolate would be used, and according to both these individuals, the choice came down to "IIIb" or another isolate, "RF."

It is remarkable that at this time, there should have been any discussion of this issue at all, since according to Dr. Gallo's account, "IIIb" reportedly had been in large-quantity production for several weeks, and had been used, reportedly, as the antigen for the LTCB HIV blood test since March 6, 1984. "IIIb" also, reportedly, had been used to generate most of the blood test data reported in the LTCB papers about to be published in the journal Science. Judging from these circumstances, it would appear that the choice -- IIIb -- had long since been made. Notably, there is no indication Dr. Popovic objected to any of this

But suddenly, by his own account, at the point a "IIIb" blood test was about to be patented and commercialized, Dr. Popovic became acutely anxious about the "origins" of the "pool virus," even to the point of advocating the delay in the blood test that would have been occasioned by the choice of an isolate other than the putative "IIIb." The interpretation that Dr. Popovic's precipitous anxiety occurred precisely because he knew or strongly suspected that "IIIb" was LAI is inescapable.

Dr. Popovic told OSI that he urged Dr. Gallo not to use IIIb for the LTCB blood test, to use instead the "RF" isolate, whose origins were well-established. Popovic's self-report to OSI of his arguments to Dr. Gallo indicate he (Popovic) was concerned about the uncertain provenance of "IIIb." Dr. Popovic told OSI that although the origin of RF was "more certain," "the best was IIIb," because the latter isolate was farther along in its growth than the former. Still, said Dr. Popovic:

"... I personally as well as Betsy [Read-Connole] told let's take out the prototype, the RF. Gallo told 'no, we have to rush because it is blood bank assay. We have to give this one [HTLV-IIIb] because this one is the best one at this time' ... if you ask for clear-cut science data, for sure, it was better to have RF ..." (6/26/90 OSI interview; transcript p. 71).

Dr. Popovic told OSI that the work with RF was done in a different laboratory -- a better organized laboratory -- than his own, where he personally performed the major experiments with LAI/LAV, LAI/MOV, and LAI/IIIb:

"The major problem is that individual isolates were under more strict control in more organized lab comparing to that where -- I worked myself [with] IIIb, MOV, LAV ... That part of work with individual isolates were done under far better conditions. So not only myself also Betsy was involved in it, we (both of us) pushed for the RF isolate, in which we were more confident, comparing to the IIIb" (op cit., pp. 109-110).

In short, according to Dr. Popovic, he was more confident in RF,

"... because the origin of it was more clear and handled under better conditions" (op cit., p. 110).

(Note: Dr. Popovic's acknowledgement to OSI that he worked with LAV in the same laboratory as the allegedly independent MOV and IIIb is noteworthy. Among other things, it casts significant doubt on a key Popovic-to-Gallo memorandum, written early in the French/American dispute, when Dr. Gallo was still adamantly insisting there was no possibility that LAV had "contaminated" the pool. In the memorandum, Dr. Popovic asserted that his work with the "pool virus," "... was almost entirely confined to the tissue culture room 6B03Awhere no LAV was ever used"[emphasis in original; Popovic-to-Gallo; September 6, 1985. Seebelowfor more information on this memorandum.)

Dr. Gallo's OSI testimony, in some respects, mirrored that of Dr. Popovic. Dr. Gallo confirmed the rationale Dr. Popovic gave for favoring RF over IIIb, namely Dr. Popovic's concerns about the murky origins of "IIIb."

"... Popovic, in fact, came to me to discuss that he favored RF for the blood test because it came from one individual, as opposed to the pool which could not be traced as well. And my response was -- and it was a big, very long, discussion -- and I said, more or less, 'Why? It's just as good to use IIIB, even if it's from 20 people, because basically we want to move as fast as we can..." (4/26/90 OSI interview; annotated transcript page 72).

On another occasion, Dr. Gallo offered a more colorful recollection of the discussion with Dr. Popovic:

"I can see Mika standing in front of me with his pipe and saying, you know, 'why don't we go with RF with the blood test' and I saying you know, 'what the hell' -- you know, 'what for.' And he said, 'well, it is -- we have the lineage much better defined. We know exactly what it is all the way.' And I said, 'Look, if this picks up, you know, this is working, it picks up, it is available now in higher amounts.' If we wait two weeks, three weeks, you know, I thought this was worse. So, that was the end of the discussion. I made a decision. You know, I made the decision. Yes, let's go with the pool and I told him" (12/2/90 OSI interview, annotated transcript, page 106).

But Drs. Gallo and Popovic's accounts of their discussions also reflect some significant differences. Most notably, Dr. Gallo's accounts consistently overstated the readiness of RF for used in the LTCB blood test, while at the same time, Dr. Gallo suggested that other factors,e.g.,patient nationality, were significant factors in his decision to use "IIIb."

Instances of Dr. Gallo's overstatements of the readiness of RF include the following:

"... we had little reason to use LAV for the blood test, we had RF available, for example, which could have been used instead of IIIB. Having developed the method, having other isolates that could have been ready within weeks, we could have also had other choices" (4/8/90 OSI interview; annotated transcript page 38).

"The point is going to be is that RF was almost as good as the pool when we were ready to form the blood test and could have been used. We could have said, 'Use this instead. Maybe you'll have to charge 10 cents or a dollar more -- I don't know -- because you don't get quite the titre'" (4/26/90 interview; annotated transcript p. 21).

On another occasion, Dr. Gallo indicated to OSI that RF was only two weeks behind "the pool" relative to its utility for an HIV antibody blood test. Dr. Gallo also invoked nationality as a significant factor in his decision to use "IIIB":

"RF was also ready ... You don't have anything to lose. Maybe you lose two weeks. You can give that to anybody to calculate. When we sent out for blood tests, we could have taken RF ... Mika favored RF ... I favored IIIB because it was American instead of Haitian. And because the count was a little bit better and I didn't give a damn if it came from ten or it came from one" (5/10/90 OSI interview; annotated transcript page 88).

It is not certain why Dr. Gallo introduced the "nationality" issue as a rationale for his selection of the allegedly all-American "IIIB." One obvious possibility is that the nationality issue was introduced to deemphasize the lack of readiness of RF as a critical consideration. Whatever the reason, the fact is that the nationality argument was bogus -- for one of the alleged "pool" samples, F6367, came from a Jamaican patient; thus, in no way was the "pool" an all-American one.

Dr. Gallo nonetheless repeatedly invoked nationality as a reason for his choice of "IIIB" over RF. In his December 2, 1990 OSI interview, Dr. Gallo said this:

"With the blood test he (Popovic) favored ... going with RF, and I said, 'Look, the IIIB is ahead of RF by some weeks and it is a U.S. versus Haitian ... The other four or five, six he had in culture were not yet well characterized, were further behind. And he favored going with RF because it came from a single patient and was well characterized, etc., etc. And I said, 'But it is a few weeks behind. Why make any delay? IIIB is from the United States, the other is from Haiti. Why do I want to have a Haitian that is two weeks behind?" (transcript pp. 101-102).

Dr. Gallo also asserted to OSI that "RF was available for expansion into large-scale culture almost at the same time as IIIB" (4/26/90 OSI interview; transcript p. 72).

But the existing evidence shows that RF -- in 1983-84 and well beyond, was discernibly inferior to "IIIB" in its titre and growth capacity. More importantly, the fact is that whatever its potential capabilities, RF was not expanded at the same time as IIIB, and this circumstance itself was another reason that at the time Gallo and Popovic were debating the issue, RF was not a genuine contender for use in the LTCB blood test.

Dr. Popovic emphasized the significance of the demonstrated growth capacity of LAI/IIIB when he described to OSI that factors that weighed in the decision to use IIIB:

"... what was in our mind is as follows: If we transfer this system into the large scale production ... would the virus producing cells behave the same way as in the small scale? We didn't know. So this was also one consideration, that if we go, we go with that which is the best, because we still didn't know if a large industrial production can work or not..." (6/26/90 OSI interview; annotated transcript p. 77).

These statements by Dr. Popovic demonstrate that large-scale, high-titre production was a critical consideration in the selection of the LTCB HIV prototype. Dr. Popovic expressed confidence that he could have achieved this with RF, but he also said that,

"... in order to be in a good position and go ahead with RF, we needed at least four weeks of work to concentrate on that one and that wasn't done" (12/1/90 OSI interview; annotated transcript p. 116).

As to whether there was any candidate isolate other than RF that might have been a contender for use in the LTCB blood test, Dr. Popovic made it clear there was not. Dr. Popovic said that aside from RF,

"... to do with any other virus isolate it was a question of starting from three to six weeks or something like that ..." (6/26/90 OSI interview; annotated transcript p. 78).

2. "Other Isolates" and the LTCB HIV Blood Test -- There was No Choice:

As described previously (p. 11), over the years, Dr. Gallo frequently asserted claims of multiple isolates of the AIDS virus, claims that steadily grew in number from 48 to "over 200." As early as April 1984, at the HHS press conference, Dr. Gallo asserted that he had "produced more than 50 isolates" of the suspected AIDS virus; yet in 1990, Dr. Gallo acknowledged to OSI that these putative isolates "are mostly detections ... by our criteria" (7/27/90 OSI interview, transcript p. 17). OSI itself could confirm no more than 10-12 of the LTCB's claimed detections/isolates. Dr. Gallo himself admitted to OSI he had only around ten isolates at the same time he was claiming 50 or more (4/27/90 OSI interview; transcript p. 61).

As the HIV blood test dispute began to escalate, Dr. Gallo stepped up his claims about the number of HIV isolates his laboratory had made. Dr. Gallo also frequently emphasized the relationship between the isolate claims and his attempts to refute the IP charge that the LTCB scientists had knowingly used the IP virus for the LTCB blood test. "RF," in particular, was frequently invoked as so worthy a candidate for the LTCB blood test that it alone should lay to rest suspicions about deliberate use of the IP virus.

Thus, for example, in his September 23, 1985 response to a series of questions put to him, at the start of the French/American dispute, by NCI Associate Director Dr. Peter Fischinger, Dr. Gallo said this:

"... we isolated, mass produced in H9 cells, patented and published on a major variant HTLV-III-RF (Haitian isolate), very different from LAV, at exactly the same time, making all this crap irrelevant. In addition, last month (August 1985) we published in the Proceedings of the U.S. National Academy ofScience on one hundred and one different isolates of HTLV-III/LAV. This paper was submitted for publication six months ago. Now the number of isolates approaches 200" (emphasis in original; p. 5).

ThePNASpaper referenced in this passage is the paper concerning which Dr. Gallo acknowledged to Subcommittee staff he could not substantiate the claim of HIV isolates dating from 1982, because no 1982 sample was tested by HIV-specific reagents. Concerning the number of isolates claimed in the paper -- 101 -- Dr. Gallo told Subcommittee staff he could document 25 - 50 isolates, but he said he also had circumstantial evidence, including some laboratory data, that up to 200 "isolates" had been tested by LTCB scientists and confirmed to be HIV. Despite repeated requests that he produce the laboratory data, Dr. Gallo failed to do so. What Dr. Gallo did produce was a June 13, 1994 letter from LTCB collaborator Dr. Robert Ting (formerly of Biotech Laboratories), who wrote to Dr. Gallo that during the period "1984 to 1985,"

"... we have received more than 2000 samples from LTCB during that period and most of the samples were for HTLV tests which included HTLV-I, HTLV-II and HTLV-III. HTLV-III samples included many of LTCB new isolator (sic.). Results of these tests were sent directly to the LTCB staffs right after the test."

This letter, obviously, confirms nothing about how many HIV isolates were obtained by the LTCB; the letter shows only that many samples were tested, for several different viruses..

Dr. Gallo's claims about multiple isolates, including "RF," that allegedly could have been used for the LTCB HIV antibody blood test, also were reflected in the Colin Norman November 8, 1985 article in Science. In a box headed "HTLV-III and LAV: Similar, or Identical," Norman wrote, based on interviews with Drs. Gallo and Popovic, that shortly after starting the "pool" culture:

"... Popovic also established virus-producing lines infected with isolates from single patients. One of these, infected with virus from a Haitian ["RF"], was included in the patent application for the method of mass-producing HTLV-III. This virus has since been sequenced and it is as different from LAV as ARV is" (p. 643).

Norman then noted Dr. Gallo's use of "RF" as a defense against a charge of misappropriation:

"Gallo argues that this ought to silence any speculation that he deliberately grew the French virus. If he already had other lines infected with other viruses, why would he sequence the virus from a line he had infected with the French isolate?

Gallo also notes that his group had several virus isolates before Montagnier's sample arrived. 'It was no big deal to get supernatant. We got that from many patients for a long, long time before he sent us this virus,' Gallo says. 'Am I going to throw away [my reputation] for a virus that is simple to isolate, and then publish its sequence with multiple collaborators? It just doesn't make sense.'"

But, as the OSI report made clear:

"... the existence of other isolates would not eliminate the possibility that the French virus was intentionally misappropriated" (p. 15).

Clearly, the existence of "other isolates" would have no bearing on the "misappropriation" issue unless any such isolate(s) were demonstrably (1) contemporaneous with LAV and (2) as readily useable as LAVat the juncturethe blood test isolate was chosen at the LTCB. In other words, it would never be adequate to assert in the abstract as Dr. Gallo frequently did, that the LTCB scientists had "other AIDS virus isolates," for in the rush to publish and otherwise claim international credit for the discovery of the AIDS virus and the creation of the HIV antibody blood test, in the rush to patent the invention, weeks -- even days -- counted. Dr. Gallo and his associates had some HIV isolates that were genuinely their own. No one disputes that this is so. But the crucial questions with respect to whether there was a motive for misappropriating the IP isolate are these: "Did Gallo et al. have even one other isolate at the critical time it was needed for the LTCB blood test?" and "Was any such isolate as readily useable as LAV?"

The answer to these two fundamental questions is clearly "no." Review of the laboratory data for RF -- invariably touted as the LTCB's best contender to LAI/"IIIB" for the LTCB blood test -- demonstrates clearly the inevitable delays that would have been occasioned by the use of RF, due to RF's not having been scaled-up for large-quantity production. The very fact that RF had not been scaled up suggests there may have been concerns about its early growth; laboratory data and testimony of LTCB scientists show there was cause for such concerns. Specifically:

-- The initial culture history of RF was decidedly unpromising. RF was put into short-term culture in mid-November 1983; by mid-December, according to Betsy Read-Connole, who worked with RF most intensively, the culture was "dying rapidly" (Gallo 4/26/90 submission to OSI; p. 2).

-- The history of RT assays of RF, such as it is, is suspect in several respects. RT assays reportedly were not done for at least the first two-to-three months of culturing of RF. The failure to perform such assays is difficult to comprehend, given the importance that Gallo et al. say they assigned to this isolate. When queried about this matter, Dr. Gallo told OSI that the lack of RT assays on early cultures of RF was due to,

"... an enormous backlog of RT samples to be run in Dr. Sarin's laboratory during the period of the RF cultures" (9/23/90 Gallo Written Responses to Follow-up Questions; Response to Question 4d).

But according to Dr. Popovic and Ms. Read-Connole, by the time RF was in culture, it wasDr. Sarngadharan,not Dr. Sarin, who was performing RT assays for the LTCB, because Dr. Sarin's assays had earlier proven to be unreliable.

-- Such information as does exist about RT assays on RF casts significant doubt on the early viability of the isolate. A January 10, 1984 note, in Read-Connole's hand, states concerning RF that, "Initial cultures negative for p19, RT and EM" (Popovic notebook; page 46).

-- The early IFA data on RF also were problematic. Tested against BRU serum on February 2, 1984, RF produced only 5-6% positive readings. On February 20, RF produced only an 11% positive reading against ET serum, while against BRU, RF was listed only as "+," which Read-Connole told OSI was the entry she used for a minimal positive reading. Notably, when describing the LTCB's culturing of the IP virus, both Drs. Gallo and Popovic repeatedly asserted that low IFA readings such as those obtained during the early months for RF, did not indicate successful infection of a permanent cell line. Presumably, Drs. Gallo and Popovic would apply the same determination to RF, meaning the RF cell line could not be considered to be permanently infected until well over two months after the initial inoculation.

-- Finally, on February 29 and March 1, RF produced high positive readings against both BRU and ET patient sera, as well as against the hyperimmune rabbit antiserum. But the February 29 assay also indicated a small positive reaction against serum from a patient infected with HTLV-I. In this regard, it is very noteworthy that Dr. Popovic, in the list of "isolates" he gave Zaki Salahuddin to use in preparing the Gallo et al. May 1984 Science paper, listed RF as anti-p19 (HTLV-I) "+/-."

-- The LTCB had no EM+ reading on RF before October 1984 (even though RF was published as EM+ in the May 1984 Popovic et al. paper). RF was sent for EMs in December 1983 and January 1984. Both reports were clearly negative for HIV; and Dr. Popovic himself later wrote to Dr. Gallo these telling words:

"Because of the lack of EM evidence in the case of HTLV-III RF isolate we decided to pursue the isolate(s) obtained from pooled culture fluids known as HTLV-IIIb" (Popovic-to-Gallo memorandum, 11/28/84; p. 2).

Dr. Gallo insisted, contrary to the expert opinion of Dr. Matthew Gonda, that the early EMs on RF were positive; Dr. Gallo even included Dr. Popovic in his (Gallo's assertion):

"... Dr. Popovic and Dr. Gallo always considered the RF culture to be EM positive and reported it as positive in our 1984 Science paper ..." (9/23/90 Gallo written responses to OSI follow-up questions; Question 4E).

As evidence for his claim, Dr. Gallo produced an EM of a sample labelled "Betsy's cells" (reportedly a code for "RF). Dr. Gallo said this sample was sent to Dr. Gonda on March 13, 1984; according to Gallo, the sample was EM+ for HIV. But no written report was ever produced showing that Dr. Gonda had found Betsy's cells to be EM+, and Elizabeth Read-Connole told OSI that neither she nor Dr. Popovic had ever seen such a report. Read-Connole also told OSI that the "Betsy's cells" EM itself was not located at the LTCB until 1990. Thus, this EM could not have been the basis for the "+" EM entry for RF in Table 2 of the 1984 paper by Popovic et al.

Despite his assertions that RF was actually EM+, Dr. Gallo acknowledged to OSI that the EM results for RF were a factor in the decision not to use the isolate for the LTCB blood test. Dr. Gallo told OSI:

"It affected us. We did discuss Gonda's negative reports because if it were produced in large amounts it would go to Frederick ... and he's saying that, you know, Gonda didn't -- He's worried that we're going to have to expand it at Frederick, and Gonda is at Frederick and is going to be gossiping, 'Oh, I didn't see anything in it'" (4/27/90 interview, annotated transcript pages 63-66).

-- RF wasnot putinto the LTCB's "best grower" clone, H9, until June 28, 1984. This attempted infectiondid notsucceed. RT data up to a week later were negative (Read-Connole Book 5; p. 35), while IFAs against the hyperimmune rabbit antiserum, which were 30-31% positive by day 13, by one week later, had fallen to half those values (Read-Connole Book 3; p. 49). Consequently, a reinfection of H9 with RF took place on July 27, less than a month after the first infection occurred. The fact that an H9/RF reinfection was required less than a month after the initial attempt indicates clearly that if the LTCB had relied on RF for its blood test, it quite likely would have confronted a much more significant delay than the "two weeks" Dr. Gallo frequently cited. "Success" with RF, in other words, was by no means assured.

The subsequent history of RF only reinforces the dubious impression of its utility, based on the early data:

-- RF was not sent for large-scale production until, according to Gallo et al., "around the end of November 1984" (Gallo submission to OSI on RF; p. 4). This date, if correct, is 9-10 months after LAI/MOV was sent to LTCB contractors for this purpose. But in fact, it is questionable if the transmission for large-scale production occurred even at the end of November, for in his November 28, 1984 "RF" memorandum, Dr. Popovic said that,

"At the present time we are intensively pursuing the single-cell cloning and superinfection of H9 cells and other target cells to achieve 80 to 90% positivity for HTLV-III,"

According to Dr. Popovic, this level of positivity, "should be accomplished within a few weeks."

-- As late as April of 1985, according to the "large-scale production" facility, Electro-Nucleonics, Inc., RF was available to be provided to AIDS investigators only in cases of "urgent need," due to the presence of mycoplasma in the cultures. (Two separate cultures of RF, designated "RF-I" and "RF-II," were identified by the laboratory as being contaminated. The origins of and distinctions between RF-I and -II have not been determined.) According to an April 17, 1985 letter signed by Dr. John Lemp, Director of the Electro-Nucleonics Cell Science Laboratory, the laboratory did not expect to have a mycoplasma-free RF culture for "several months." Thus, even this late, more than one year after the LTCB initiated mass production of virus for its HIV blood test, RF was not ready for even routine use.

-- RF-I, at least, was not a satisfactory grower. Minutes of a July 1985 meeting of the NCI Vaccine Development Group record a discussion of the problematic growth of "RF-I," which had been sent to the Frederick facility, presumably for mass production for work on an AIDS vaccine. The minutes show that the meeting participants, who included Dr. Popovic, agreed that RF-I should be replaced with "RF-II," not otherwise identified except as being available from Dr. Popovic.

-- Independent testimony from the scientist at Frederick who worked with mass-production of the LTCB's isolates confirms the lower productivity of RF. Dr. Larry Arthur, Director of the AIDS Vaccine Program at Frederick, told OSI that RF, which he received "well after" he first received IIIb,

"... was a lower producer than the IIIb in our hands" (1/28/91 OSI interview; annotated transcript pp. 19-29).

3. There Was No Time For Delay:

The evidence clearly shows that RF was not a viable candidate for use in the LTCB HIV antibody blood test; the few other theoretically-available isolates(e.g.,LS, BK) were even less likely prospects than RF. If Dr. Gallo and his associates had had more time, they might well have been able to scale up other isolates as potential candidates. Butthere was no more time.At the point at which the isolate choice was made, Dr. Gallo had already told his superiors at the NCI, as well as scientists at CDC and at several meetings in Europe about his putative discoveries. The Assistant Secretary of Health also had been briefed, and provided copies of the fourSciencemanuscripts, which had just been submitted.

In this regard, it is very notable that Dr. Gallo himself moved up the submission date for the papers by a full month, indicating clearly the accelerated timetable he had imposed on the laboratory. This event in and of itself committed the LTCB scientists to "IIIb" as the LTCB prototype, including its use in the LTCB HIV antibody blood test. Dr. Popovic told OSI that advancing the submission date of the papers meant his paper would have,

"... to focus on HTLV-IIIb as a prototype instead of the RF isolate whose origin was more certain" (12/1/90 OSI interview; transcript p. 8)

and

"At that time when we had to go ahead, the best was IIIb and practically it was not difficult to choose whether IIIb or RF would be ... but for sure his [Gallo's] choice was IIIb ... that time what we have the best, we go ahead. That was a decision" (op cit., pp. 115 - 116).

By April 11, NCI was moving actively to prepare patent applications. There was a particular urgency to this effort. Unless Gallo et al. filed their United States blood test patent application before there was any disclosure of the invention, they would forfeit their foreign filing rights. With news of the Gallo et al. blood test about to appear, much of it due to leaks engineered by Dr. Gallo himself, it was essential that the patent applications be filed immediately.

Under these circumstances, it clearly would have been unthinkable for Gallo et al. to suddenly announce a delay of a month or more while they attempted to scale up another isolate and re-run their blood test data with that isolate, whose origins were "more certain" than the isolate they originally had chosen. Heterogeneity of HIV had not been discovered at this time; thus, there was little reason to fear that the use of LAI would be found out. For this reason and because there was no more time, the LTCB scientists had no choice but LAI/"IIIb" for the LTCB blood test.