VIII. HHS Initial Response

A. The HHS Mindset

The overriding tenor of the HHS response to the IP assertions and demands seems to have been one of instinctive defense of the U.S. claims, rather than concern as to whether those claims were valid. There was no effort on the part of HHS to mount an objective inquiry into the facts; instead, every effort at HHS was devoted to how best to defend the HHS patent and the HHS scientists. Whether or not they warranted defense, whether or not they could legitimately be defended -- these, apparently, were not among HHS' concerns.

The prevailing attitude, indeed mind-set, was well-exemplified by Peter Fischinger, who played a crucial role during the early months of the French/American dispute. Fischinger described his reactions to the IP challenge to Subcommittee staff in these terms:

"I was somewhat incensed, because the feeling was that 'you've gotten the virus from us... and you might have stolen it or at best, you might have mixed it up'" (8/6/93 Subcommittee staff interview; tape 4, side 2).

Explaining his "incensed" reaction, Dr. Fischinger said:

"Well, it was kind of extraordinary -- based on what I knew, I thought it was kind of a very significant contention ...

"I thought there was a pretty good track record of discovery of the virus in Gallo's laboratory. And the fact that the two viruses might have been very close, but there was enough of a distinction that Gallo and Montagnier isolated the same sub-type of virus ... my feeling was, 'so what?'" (op cit.).

Dr. Fischinger's further statements to Subcommittee staff showed the extent to which Dr. Gallo's assertions about his alleged "early isolates" of the AIDS virus, together with his assertions about his inability to grow LAV influenced his (Fischinger's) reactions to the IP challenge:

"My whole attitude was he [Gallo], obviously -- and everybody else with him -- 'of course we didn't use LAV,' I mean, 'we couldn't even grow it. How could we?' ...

"It could not have happened, and the fact that the two viruses were the same, there were other matched pairs ... The facts that I had, I was incensed, it was outrageous, an outrageous sort of a claim. I had a full sense that this was an independent isolation, verification, putting together the first definite association between the test and the disease ... I really felt that the U.S. team had a very significant claim and priority" (op cit.).

Then-NIH Director Dr. James Wyngaarden confirmed this perspective to Subcommittee staff. Describing the HHS approach to the IP challenge, Dr. Wyngaarden said this:

"... almost everyone at NIH really believed Bob was ... maybe not generous to the French but that he had the data himself, had done it himself. The feeling was very strong that the French were trying to muscle in, trying to take credit ... that Bob had earned ...

"At the time, everyone in the system thought the French were trying to take credit for Bob's work, that they were putting more credit on Montagnier than was warranted. Everyone up and down the line felt that -- of course, we were relying on Bob's account of what he had done" (9/27/93 interview with Subcommittee staff).

Queried as to how the entire HHS fact-finding process could have relied so heavily - nearly exclusively -- on Dr. Gallo's assertions about his research, Dr. Wyngaarden said this:

"He can be very persuasive ... Bob is exceptional in his capacity to integrate information from lots of sources and integrate it into a persuasive, coherent statement of what it means ... His mind in my view is in a class by itself for that sort of thing" (op cit.).

Reflecting his awareness of the potential pitfalls of so "persuasive" a presentation, Dr. Wyngaarden added this:

"I gather he made some scientific claims in the 70s and 80s that hurt his reputation .... Usually the scientific process takes care of that -- if someone is out on a limb, someone else saws it off. It's not uncommon to overinterpret. You can be overwhelmed by it" (op cit.).

NCI/HHS' mind-set was in evidence immediately after the meeting with the French delegation. HHS officials, still under the chairmanship of Dr. Lowell Harmison, met to plan their strategy for dealing with the IP challenge. According to Tim Miller's memorandum to Secretary Heckler, in the HHS officials' meeting, Peter Fischinger discounted the IP claim that Gallo et benefitted from their access to confidential information from the Pasteur scientists. According to Miller, Fischinger said:

"... the key to the invention is not its isolation [the AIDS virus]; rather the key was the development of the 'cell line' necessary to produce the virus in large quantities..."

Miller also recorded that:

"Dr. Peter Fischinger believes we can develop evidence to show that Dr. Gallo had isolated the retrovirus on his own as early as February 1983, although he had not specifically identified the retrovirus at that time."

B. Gallo and Popovic Respond

The practical outcome of the HHS meeting was that the National Cancer Institute (NCI) was charged with conducting "an internal mission" to determine if any evidence existed to substantiate the IP claims. Peter Fischinger, quite clearly, had already made up his mind about the principal points of contention; yet Fischinger was placed in charge of the "internal mission," which nominally included the NIH patent attorneys, but in reality was a solo mission for Dr. Fischinger.

Pursuant to his mission, the day after the meeting of IP and HHS representatives, Dr. Fischinger wrote a memorandum to Dr. Gallo, describing the major points made by the IP representatives. Fischinger said the thesis of Robert Nowinski, the chief scientist for GS, was that:

"... the basis for the filing of the U.S. patents for the blood tests was incorrect. The reason was that (the) key component of the test, i.e., the virus, was not of U.S. origin .... His thesis ... was that LAV and the HTLV-IIIb were actually one and the same, and that your laboratory somehow re-isolated the LAV and proceeded to deal with it as HTLV-III from then on" (8/7/85 Fischinger-to-Gallo memorandum).

Dr. Fischinger described the objectives of his HHS-mandated mission, and he told Dr. Gallo what was needed from the LTCB:

"NCI was to examine the events leading to the discovery of HTLV-III. In that context, the documents cited by Mr. Weisser (sic.) will be necessay (sic.) if available. These include all correspondence between your laboratory regarding the timing [of] the acquisition of LAV from France and the reciprocal transmission of HTLV-III and cells to the IP.

Second, the documentation of the review process of the Barre-Sinoussi Science paper with input from the editors and other reviewers will be needed" (op cit., pp. 2-3).

The final element of Fischinger's document request to Gallo is noteworthy. It shows how, at the very outset of his inquiry, Dr. Fischinger had determined to rely on the "other isolates" defense against the IP charge that Dr. Gallo used LAV for the LTCB blood test:

"Third, please assemble adequate documentation from your laboratory data that you have isolated an HTLV-III agent(s) prior to the receipt of LAV. Standard virus differentiating criteria would be useful, such as electron micrographs, inability to immortalize T4 cells and negativity of reactions with antibodies to p19 or p24 internal proteins which identify HTLV-I or -II" (op cit., p. 3).

Dr. Fischinger's memorandum to Dr. Gallo concluded with this:

"Your response will be useful in determining the future course of actions of HHS. Obviously, because these allegations have a significant negative bearing on your personal reputation and scientific integrity, please feel free to discuss alternative actions which would rectify the thrust of the above-cited allegations" (op cit., p. 3).

Dr. Fischinger's memorandum to Dr. Gallo was the starting point for a series of memoranda from Gallo and his staff to Fischinger, along with selected pages of data. The significance of the LTCB scientists' submissions and the resulting so-called "Fischinger report" cannot be overstated.

In numerous instances, the memoranda were forwarded from NCI to HHS officials and to HHS and DOJ attorneys. In a number of instances, the contents of the memoranda were incorporated, often nearly verbatim, into official HHS and DOJ documents, including the Fischinger report. This report, initially provided to Lowell Harmison, was forwarded to HHS attorneys and later, to the Department of Justice, where it was represented as the definitive NIH/HHS statement of facts concerning the substantiation for the claims of Gallo et al. The August/September 1985 Gallo/Popovic memoranda, supplemented by interviews with Gallo, Popovic and other LTCB scientists, also were incorporated into briefs and pleadings filed by DOJ attorneys on behalf of the U.S. Government.

(Notably, most of the Gallo/Popovic memoranda, along with Fischinger's August 7 memorandum and the "Fischinger report" itself, were withheld from the IP under FOIA. One memorandum -- an August 23, 1985 memorandum from Fischinger to Gallo -- also was withheld, but unlike the other memoranda, was not included on the legally-mandated "Vaughn index" of putative FOIA-exempt documents, almost certainly due to its extraordinary sensitivity (see below).

In short, the documents generated by the LTCB scientists formed the framework for the entire U.S. Government defense. But many important facts were not revealed by the LTCB scientists; numerous significant items of data were not provided by them to HHS and DOJ officials. Moreover, many of the assertions contained in the LTCB scientists' submissions could not be substantiated. Thus, the entire U.S. Government defense was constructed on a false and defective infrastructure.

But incomplete and incorrect information emanating from the LTCB was not only problem with the HHS inquiry. From the beginning, the inquiry was directed away from the issues that were the real focus of concern, the issues on which Gallo et al. were most vulnerable, toward a number of irrelevant, "red-herring" issues behind which HHS apparently hoped to find cover (e.g., the LTCB's alleged "other isolates").

It is clear from accounts of the August 6, 1985 meeting that two sets of issues, above all, were the real foci of concern: (1) what did Gallo and his colleagues do with LAV at the LTCB, in particular, could Gallo et al. document that IIIb/H9 was derived independently of LAV and (2) what HIV isolate did Gallo et al. use to make the LTCB HIV antibody blood test, and when was the blood test created? Curiously, neither of these sets of issues was posed by Dr. Fischinger to Dr. Gallo, in Fischinger's August 7 memorandum. Fischinger was asked by Subcommittee staff what questions he was trying to answer in his inquiry and why, for example, he sought from Dr. Gallo evidence of "HTLV-III" isolation "prior to the receipt of LAV."

Dr. Fischinger's response revealed how, even at the outset of his inquiry, he believed he knew the facts:

"I guess I was so convinced of the fact that the charge was so outrageous, and I thought, 'if you can show that you obviously had it (HTLV-III) -- if you got it and had it growing, it was fine, and you can develop a test with it, you really wouldn't have to do it [misappropriate the IP virus]" (8/6/93 interview with Subcommittee staff; tape 3, side 2).

Dr. Fischinger agreed with Subcommittee staff that he felt he already knew the truth, i.e., that the IP claims were false. Thus, Dr. Fischinger said, he believed his task with respect to the LTCB scientists was this:

"Show me that these charges were kind of outrageous. That was my feeling at the time."

What is remarkable about Peter Fischinger's indirect approach to his investigation is that documentary evidence shows Dr. Fischinger knew well that the indirect approach would not be adequate, recognized well what were the central issues in the dispute and what kinds of data Gallo et al. would have to provide to substantiate their claims. This is evident from an August 23, 1985 memorandum from Fischinger to Gallo. The sensitivity of its contents are seen in the fact that the memorandum was not produced by NIH to the Subcommittee until September 1993, more than 18 months after the Subcommittee's initial document request, well after the staff's interview with Dr. Fischinger, and only after numerous communications to HHS concerning document withholding, particularly at NIH.

The August 23 memorandum specifically targeted the major issues embodied in the IP challenge, identifying them as, "three major areas of oversight" in Gallo's data/document production "which have to be completed." The "major areas of oversight" included issues about which Subcommittee staff questioned Dr. Fischinger, e.g., the origins of "IIIb" and the development of the LTCB blood test. Dr. Fischinger downplayed the significance of these issues, yet his memorandum makes clear he recognized well they were central to the validity of the claims of Gallo et al.

Dr. Fischinger's obvious awareness of the critical nature of the "major areas of oversight" makes it all the more remarkable that at the time Dr. Fischinger wrote the August 23 memorandum to Dr. Gallo, the first draft of the "Fischinger report," including its conclusions, had already been completed. These circumstances demonstrate graphically that HHS was determined to proceed with its defense of Gallo et al., no matter what the truth might be. (See below for information on Gallo's response to the August 23 memorandum.)

The LTCB information production process began on August 14, 1985, when Dr. Gallo and his associates, particularly Mikulas Popovic, commenced the transmittal to Dr. Fischinger of a series of memoranda, some of them accompanied by selected laboratory notes, apparently intended to address the issues raised by Fischinger in his August 7 memorandum, and later, his August 23 memorandum.

The inaccuracies and omissions in the LTCB documents were incorporated, often nearly verbatim, into key documents in the U.S. Government defense of Gallo et al. Examples of these false and misleading claims appear in the Executive Summary of this report (here). The most important such items from the Gallo/Popovic August 1985 memoranda are as follows:

1. Responding to Dr. Fischinger's requirement for "documentation from your laboratory data that you have isolated an HTLV-III agent(s) prior to the receipt of LAV," Dr. Gallo provided no data that met the stated requirements. Several samples were identified, including the suspect December 15, 1982 samples. But no evidence was supplied to show that any of these samples had ever been tested and found positive for HIV. In fact, no such evidence existed. (Gallo-to-Fischinger; August 14, 1985).

    

2. Concerning the LAV samples received at the LTCB in 1983, Dr. Gallo said July LAV "... did not contain detectable virus" (Gallo-to-Fischinger; August 19, 1985). An appended memorandum by Dr. Popovic made no mention whatsoever of July LAV.

    

3. Concerning September LAV, Dr. Gallo said only that, "Dr. Popovic reports he was able to detect RT..." (Gallo-to-Fischinger; August 19, 1985). Dr. Popovic, in his appended memorandum, described the September LAV sample as "a small amount of extracellular virus particles." Dr. Popovic did not mention any of the positive IFA results with LAV prior to December 1983. Popovic did mention the infection of Ti7.4 with LAV, but he dated it to December 1983, rather than October. There was no mention of the LAV infection of HUT-78. Dr. Popovic said the LTCB scientists had determined that LAV and "HTLV-III" "had cross reactive major proteins," but Dr. Popovic did not say when this determination was made. Most significantly, Dr. Popovic did not reveal that LAI/LAV was tested and found positive against the rabbit antiserum; neither did he or Dr. Gallo make any mention of the LTCB's molecular analyses of LAI/LAV, including the comparisons that showed LAI and IIIb were identical.

    

4. Concerning the putative "pool" virus, Dr. Gallo made the following statement, contrary to all available evidence:

    

   "Material placed into the permanent cell line H9 and published in May 1984 to develop reagents and molecular clones was pooled from several patients who showed high RT activity in primary culture" (Gallo-to-Fischinger; August 19, 1985).

    

5. Dr. Gallo asserted, without substantiation, that the uniquely close relationship between IIIb and LAV, "... probably represents the similarity within the known range of variation of viruses isolated from different patients at different times" (Gallo-to-Fischinger; August 19, 1985).

    

Besides their memoranda, Drs. Gallo and Popovic also submitted approximately 100 pages of data to Dr. Fischinger. The data pages were essentially useless. Numerous pages were illegible; on many pages, identifying information for individual samples had been removed, making it impossible to trace what was done with particular samples. Other pages contained no data, only lists of samples sent for, e.g., RT or EM analysis. Most significant, the data pages included only one page that even mentioned "LAV." This page, dated "9/22/83," showed LAV was used to infect four cord blood cell lines. However, no pages containing results for these cultures were provided to Dr. Fischinger, neither were any data included from the LAI/LAV infections of the five permanent T-cell lines.

As for the LTCB HIV antibody blood test, the data package contained none of Dr. Sarngadharan's ELISA data. Thus, Dr. Fischinger had no way to determine when the first LTCB blood tests were performed; neither was he able to recognize that the LTCB HIV ELISAs for two months were performed with antigen from a virus called "MOV," not with the patented isolate, "IIIb".

Betsy Read-Connole gave important information to Subcommittee staff concerning how the data package was created for Dr. Fischinger. Read-Connole initially said she was "told to copy everything," but then she added, "I helped select it." Most important, according to Read-Connole,

"We were told not to put the LAV stuff [in the August data package] ... they wanted the other stuff."

Read-Connole said she did not know the origin of these specifications, neither did she know to whom the data were sent, once they were assembled.

Dr. Fischinger, apparently, did little more than glance at the data he was given by Gallo et al. When Subcommittee staff showed him the data pages provided in August 1985, Dr. Fischinger said this:

"This is much more than I remember seeing. I don't think I've seen all of that" (8/6/93 interview; tape 3, side 2).

Asked if he had reviewed the data pages one-by-one, and if he knew why he was given those particular pages, and not others, Dr. Fischinger's response was this:

"There were others?"

Dr. Fischinger was informed that among the pages he was given, there was only one page that even mentioned "LAV." Asked if this had struck him as odd, Dr. Fischinger said:

"I don't think it would have struck me as odd, because again, my sense was, 'show me that you developed the test on your own, independently'" (op cit.).

Yet when Dr. Fischinger was asked if he received and reviewed actual data related to the LTCB HIV blood test, his response was this:

"I don't remember the specific development of the ELISA test in the laboratory."

Attempting to explain his evident inattention to the LTCB data, Dr. Fischinger said,

"A lot of it was very hard to understand, very difficult."

Dr. Fischinger was asked if he asked Popovic or Gallo or anyone from the LTCB to interpret the data for him. Fischinger's response was revealing:

"I tried to rely on some of the summaries of the data, as opposed to going through it page by page ... I think I remember sort of receiving sort of an occasional sort of summary of what happened, but I did not go with Popovic through this page by page."

Because Dr. Gallo claimed to Subcommittee staff that in August/September 1985 he had no idea of the seriousness of the French/American dispute, Dr. Fischinger was asked if he attempted to instruct Dr. Gallo about the matter. Fischinger's response showed that he attempted to keep the focus of responsibility on Dr. Gallo:

"Yes I did. In terms of the point, you have to get all the data ... in terms of what he had in hand. And then refine it for us, because of the difficulties of the notebooks. And I did tell him that he would have to stand or fall in terms of those data and that ... he would basically have to swear to the fact that that's what it is ... that if it ever came to a more significant sort of examination, that he would have to then go into a wealth of detail that wasn't feasible in that timeframe" (op cit.).

Dr. Fischinger made clear that Dr. Gallo was his principal contact and source of information and the person ultimately responsible for the LTCB scientists' work. Asked if he consulted with Dr. Sarngadharan, who performed the ELISAs, made the HIV-specific rabbit antiserum, and performed the seminal protein analyses for the LTCB, Dr. Fischinger said this:

"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 on. 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" (op. cit.).

Dr. Fischinger added this:

"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, as opposed to my going -- kind of a detailed, detective-type investigation, which I didn't do.

I mean, that was clear. That wasn't done until sometime later. I said, 'Look, this is what you did. This is the summation of [what] you had and said in your laboratory data to prove it. And let's take it from there" (op cit.).

C. The "Fischinger Report"

Peter Fischinger's response to Lowell Harmison's directive to him to "examine the events leading to the discovery of HTLV-III" was a written report in the form of a memorandum, identified herein as "the Fischinger report." The report was prepared in a great hurry; an initial draft was prepared by August 21, two weeks to the day after Fischinger started his "inquiry."

The final version of the Fischinger report was dated August 27. The report was routed through NCI Director DeVita, NIH Director Wyngaarden, and HHS attorney Darrel Grinstead. Grinstead's sign-off apparently occurred on or about September 9, a notable date because of several significant events that occurred prior to that time (see below). The final version of the report comprised these elements: (1) an 8-page memorandum from Fischinger to Harmison, (2) an addendum titled "Further considerations Based on the Documents Sent to HHS by the Institut Pasteur Director, Dr. Dedonder," (3) an August 21 memorandum from Gallo to Fischinger attesting to the accuracy of the information in document (4), and (4) a document titled "Background Information: U.S. Patent Applications."

The Fischinger report was a compendium of irrelevant, misleading, and outright false claims; the report also reflected many significant omissions (see below). The inclusion of numerous misleading elements in the Fischinger report is noteworthy, given that both Fischinger and Gallo signed statements attesting to the accuracy of the report and asserting that the statements in the report could be substantiated by laboratory data and records. Specifically, in a cover page for the "Background Information" document, Dr. Fischinger signed a statement that said this:

"NCI requested specific documentation of data from Dr. Gallo's laboratory, and received about 100 pages of copies of laboratory notebooks, as well as abstracted summaries of these data. Although some of these data are cryptic and very difficult to follow, enough clarity emerged to make the enclosed comments."

Dr. Fischinger added that "the resulting document," compiled by his office "... was next sent to Dr. Gallo to determine that it was accurate in both its content and interpretation." Dr. Fischinger cited an "enclosed concurrence statement" signed by Dr. Gallo; the statement, in the form of an August 21 memorandum from Gallo to Fischinger, said this:

"The enclosed attachment 'Background Information, U.S. Patent Applications,' 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 Cell Biology, NCI."

Dr. Gallo added this:

"I stated previously, and I furthermore still believe myself to be the first inventor of subject matter covered by Patent Application #602,946, and the issued patent number 4,520,113, which are critical to the realization of the blood antibody test which measures exposure to the HTLV-III/LAV virus."

Following is a listing of the most significant problematic statements in the Fischinger report. In most instances, the extensive evidence demonstrating the inaccuracy of these statements has been discussed. Pertinent page references are noted as appropriate.

(1) "The examination of data from Gallo's laboratory showed that in mid-December 1982, the first HTLV-III-type isolates had been identified from AIDS patients" (8/27/85 Fischinger-to-Harmison memorandum; p. 2.

"The Gallo laboratory already had very analogous data from AIDS patients as early as December 1982 ... the Institut Pasteur observations corroborated analogous pre-existing data in the NCI laboratory" (op cit., p. 7).

The LTCB December 1982 data did not substantiate "HTLV-III-type isolates"; see above. Dr. Gallo himself repeatedly asserted he made no claims of priority based on the 1982 data. Dr. Gallo's data also were not analogous, much less "very analogous" to those of the IP scientists. The IP scientists' data were considerably more extensive and informative than the LTCB data. Moreover, the IP scientists' understanding of their data was well advanced compared to that of Gallo et al. (see above).

(2) "Based on the examination of raw and compiled data ... between June 1983 and September 1983, it can unequivocally be stated that the Gallo laboratory had more than ample isolates of typical HTLV-III which could have been used as prototype (sic.) infectious agents" (op cit., p. 3).

"... 17 different retrovirus isolates were obtained from AIDS patients during that time ... Aliquots of some of these virus samples are still available. Therefore, the above isolates had the same criteria as the infectious LAV subsequently received at the end of September 1983" (op cit., pp. 3-4).

The statement that the LTCB scientists had "ample isolates of typical HTLV-III" by September 1983 is untrue. The LTCB's putative "isolates" between June and September 1983 were, virtually all, not isolates but, at the most, occasional detections. More importantly, none of them was known at the time to be "typical HTLV-III." The great majority of them were never tested and found to be HIV. None was useful as a prototype, because none was grown in sufficient quantity to be useful (see above).

Also significantly misleading is the unqualified assertion that Salahuddin/Markham's "isolates" "had the same criteria as the infectious LAV subsequently received at the end of September 1983." This statement is not correct. The data on both July and September LAV were considerably more substantial than the data on any of the Salahuddin/Markham "isolates." Both July and September LAV were tested and found positive by IFA against pre-AIDS patients serum and both were found positive for lentivirus by electron microscopy. None of the Salahuddin/Markham isolates "had the same criteria" (see above).

(3) "... how complete or convincing was the French data in May 1983? What was described was reverse transcriptase (RT) activity in a single lymphadenopathy patient, without p19 and p24 HTLV-I cellular reactivity, and electron micrographs of budding particles from degenerating cells ... At that time, the French also considered their virus isolate to be a member of the HTLV family" (op cit., p. 2).

Dr. Fischinger's statement that the IP scientists, in their May 1983 paper, showed there was no "HTLV-I cellular reactivity," is noteworthy because it is true. The statement thus stands in marked contrast to repeated statements by Dr. Gallo, the most notable of which is the statement in Gallo's November 1986 declaration that,

"... the Pasteur group reported a major cross reaction with HTLV-I" (Emphasis supplied; 11/8/86 Declaration of Robert C. Gallo).

Notwithstanding his accurate statement about the absence of HTLV-I reactivity, Dr. Fischinger asserted incorrectly that "the French also considered their virus isolate to be a member of the HTLV family." Dr. Fischinger either did not know about or deliberately withheld information concerning Dr. Gallo's role in rewriting the IP paper, including adding the assertion that LAV was a member of the "HTLV family" (see above).

(4) "The receipt of the following materials from L. Montagnier is acknowledged by Gallo's laboratory:

1. 20 micrograms of 'LAV proviral DNA' was received April 1983. No viral DNA was present, only cellular DNA.

2. Supernatant fluids of one patient's T cells, not with AIDS but with lymphadenopathy, were received in July 1983, which did not contain any infectious LAV virus.

3. In late September, a second sample supernate from T cells of the above patient was received and did contain the first infectious LAV. It was successfully transmitted only to normal T cells and a human cell line Ti7.4. Thus there was no logic for the motivation to use the Institut Pasteur derived LAV in any infection sequence for any purposes other than a comparative analysis" (op cit., p. 4).

 

The numerous false and misleading aspects of the above passage are readily obvious from the prior discussion of the LTCB's use of the IP virus. Most notable are the assertions that July LAV "did not contain any infectious LAV virus" and that September LAV "was successfully transmitted only to normal T cells and a human cell line Ti7.4." The claim that "no viral DNA was present" in the LAV DNA sent to the LTCB in April 1983 was seriously misleading and could not be substantiated. The only claim that could be substantiated was the claim that no HTLV-I or -II DNA was present, as one would expect, because these were the only human retroviruses for which Gallo et al. could test the LAV DNA.

(5) "Dr. Popovic later attempted to infect the parental uninfected H9 cells with the LAV isolate from the Institut Pasteur. The total amount of reverse transcriptase activity obtained (appr. 20,000 cpm) was inadequate to initiate an infection of continuous cells" (op cit., p. 8).

The authenticity of the experiment cited by Fischinger is suspect on many counts (see above). The claim concerning RT activity is particularly questionable, for no RT data associated with the putative attempt to infect H9 with LAV are known to exist.

(6) "... an innovative technique of pooling of several highly RT-positive samples was used to infect the H9 subclone. Although under normal circumstances, pooling of isolates would be considered unusual, up to that time no one had been able to stably infect a continuous T cell line with HTLV-III despite repeated single isolate attempts" (op cit., p. 4).

Only one of the samples allegedly used for the "pool" experiment was known to be RT+ at the time it was used. Several of the samples were never tested and others, when tested, were RT-. As for Dr. Fischinger's attempt to justify the "unusual" pooling methodology, on grounds that all previous single isolate attempts had failed, this statement fails to take into account the successful growth of LAI/LAV and LAI/MOV.

(7) "The subsequent virus-releasing cell subline, designated HTLV-IIIb, has multiple DNA proviruses in it, based on hybridization and DNA sequence data. Two of these have been cloned and they are related but not identical. Neither of these proviruses is identical to LAV, and although they are close, they differ significantly by about 1-2% from LAV ... recent DNA sequence data show that exceedingly closely matched pairs of viruses have been isolated from different individuals. These pairs are as close as, or closer in relationship than LAV is to HTLV-IIIb" (op cit., p. 5).

Dr. Fischinger's statements about the "IIIb" cell line embodied several interrelated, highly speculative, unsubstantiated assertions:

1. the implication that the "IIIb" clones represented different "proviruses" derived from different samples placed in "the pool";

2. the implication that the sequence similarity of the IIIb clones showed that independent isolates from different individuals can be much alike;

3. by extrapolation, the assertion that sequence similarity of the IIIb "proviruses" to LAV -- misleadingly described by Fischinger as differing "significantly" -- permitted the possibility that "LAV" and "IIIb" were independent isolates.

    

As for the "closely matched pairs .. as close as or closer in relationship than LAV is to IIIb," Dr. Fischinger did not specify the pairs to which he was referring, and there is no evidence that they actually existed. Dr. Gallo did publish on one isolate pair -- "MN" and "SL" -- (Wong-Staal, et al., Science, 229, pp. 759-762. But Dr. Gallo later told OSI that,

"... the close similarity of isolates MN and SL is now believed to be due to a mix-up of samples" (4/27/90 OSI interview; transcript p. 76).

(8) "On detailed analysis of their more than 130 isolates, the conclusion is that there are not a few strains of HTLV-III/LAV but a continuum. Any one isolate has closely related 'relatives' (1 to 2% difference) and distantly related 'relatives' (more than 5% genomic diversity)" (op cit., pp. 5-6).

The discussion of item 7 above demonstrates the dubious nature of the assertion that "any one isolate" has "closely related" virus relatives, where "closely related" is defined as "1 to 2% difference." Notwithstanding Gallo/Fischinger's claims, there was no reliable evidence that genuinely independent HIV isolates might be only 1 - 2% different in their genetic make-up.

(9) "... the French could not develop an effective diagnostic test until more than one year after this publication [Barre-Sinoussi et al., May 1983], and after Gallo's discovery as defined in the U.S. patent application #602,946" (op cit., p. 3).

"... no effective action was taken by the French group to develop a meaningful diagnostic test" ("Background Information: U.S. Patent Applications"; p. 1).

"Who first linked the correct virus unequivocally to human AIDS? Dr. Gallo's group had precedence in this area as well by more than two months ... the subsequent joint manuscript from the Centers for Disease Control (CDC)and the Pasteur group was numerically much less firm" (op cit., p. 2).

"Even in July 1984, the LAV-containing test systems picked up only 41% of AIDS patients" (op cit., p. 9).

The fact is that the IP scientists developed an effective, accurate HIV blood test long before Gallo et al. did so. The evidence is compelling that Dr. Gallo knew about this blood test when he filed the patent application for his own test (see above here and also here).

Dr. Fischinger's assertions relating to the CDC/IP paper (the July 1984 "LAV-containing test systems) were significantly misleading. The paper in question reported results for two kinds of LAV antibody blood tests. One test, a blood test technologically different from that of Gallo et al., scored 41 and 72 percent positive in AIDS and pre-AIDS patients, respectfully. However, the other test, comparable to the test of Gallo et al., was fully as good as the LTCB test -- 70-95 percent positive in AIDS patients; 95 percent positive in LAS or pre-AIDS patients.

During the entire patent dispute, up to the present day, Drs. Fischinger and Gallo never cited the latter set of results. Rather, they and the U.S. Government attorneys as well invariably cited the former set of results, never mentioning the differences in the nature of the tests that produced those results. Nor did Gallo, Fischinger, or any of the U.S. representatives ever mention the CDC data, of which Dr. Gallo had personal knowledge, that showed the IP and LTCB blood tests performing equally well in detecting antibodies to the AIDS virus.

(10) "To get the LAV ELISA operational, the Institut Pasteur and their U.S. licensees also had to adapt LAV to a continuous human leukemic T cell line. It is of interest that they eventually used the HUT-78 cell line which is a relative of the HT cell line developed by Dr. Gallo" (op cit., p. 10).

These statements were entirely incorrect. The IP scientists did not use HUT-78 to grow the virus for their HIV blood test. The cell line of which they made principal use for their blood test was CEM. Moreover, contrary to Dr. Fischinger's assertion that HUT-78 and HT are "relatives," the fact is that HT is HUT-78.

There is evidence that by the time Fischinger wrote his report, both Popovic and Gallo knew or had reason to know that HT was HUT-78. Based on Dr. Fischinger's August 23, 1985 memorandum to Dr. Gallo, it appears that Fischinger himself remained uncertain and was seeking information about the origins of HT/H9. Yet despite his uncertainty, Dr. Fischinger wrote unqualified assertions about the origins of "HT" into his report to Harmison, assertions that neither Fischinger nor Gallo could substantiate. In addition, it bears mention that this passage is but another instance in which Gallo, contrary to his latter-day denials, endorsed the claim that he "developed" the HT cell line.

(11) "There is no evidence that material from any outside laboratory including the French, was used in generating the HTLV-IIIb virus" (op cit., p. 3).

"It is clear from other sections of this document that LAV was not used in generating the HTLV-IIIb virus strain advertently or inadvertently" (op cit., p. 8).

"It is acknowledged that Dr. Gallo reviewed the French, May 1983, manuscript, and supported its publication, and that Dr. Popovic received the LAV isolate and signed the appropriate forms. However, because none of the above information or material was used in the generation of the U.S. inventions, the above acknowledgements are not germane to primacy of inventorship" (op cit., p. 4).

The only reason there was "no evidence" of the use of outside material in the isolation of IIIb was that Dr. Fischinger did not look for the evidence, and such evidence as he had, he failed to examine. In this regard, it is important to remember that approximately one year before Dr. Fischinger wrote his report, he (Fischinger) was told by Gallo -- not once but on two occasions -- that IIIb and LAV were genetically identical. Dr. Fischinger's assertion, one year later, that there was "no evidence" that LAV was the source of IIIb is directly contradicted by the documentary record, including documents generated by Drs. Gallo and Fischinger themselves (see above).

It also must be noted that in his August 23, 1985 memorandum to Dr. Gallo, Dr. Fischinger made it clear that a "critical," "major area of oversight" in the information Dr. Gallo had previously provided was Gallo's failure to describe "the exact sequences and timing of the events which led to the virus-producing line HTLV-IIIb." In light of these fundamental unresolved issues, Dr. Fischinger's unqualified, definitive assertions to Harmison and other HHS officials that LAV was not used for the LTCB blood test are impossible to fathom.

D. Beyond the Fischinger Report

1. The Grinstead Response:

When the Fischinger report reached HHS, a telling exchange took place between Darrel Grinstead, Assistant General Counsel in the Business and Administrative Law Division of the HHS OGC, and Dr. Lowell Harmison. Grinstead reviewed and, on September 9, 1985, signed off on the Fischinger report. But Grinstead, apparently, was not comfortable with an unqualified sign-off; consequently, on September 9, Grinstead wrote an extraordinary memorandum to Harmison.

Grinstead's memorandum is exceedingly important. It shows that Grinstead, the HHS attorney who would soon occupy a key role in HHS' defense of Gallo et al., had significant reservations about the claims of Gallo et al., reservations that were on point and well-founded. Notwithstanding those reservations, Grinstead and other HHS officials gave tacit or explicit endorsement to the Fischinger report, which thereby came to represent the official HHS position concerning the claims of Gallo et al.

In his September 9 memorandum to Lowell Harmison, Darrel Grinstead said he had reviewed and initialed the Fischinger report. Yet at the same time, Grinstead's (at best) tepid observations about the report made clear he was not enthusiastic about its contents. Here is what Grinstead said:

"... I think Dr. Fischinger's report is a useful analysis of the scientific and legal issues that appear to have been raised by the French ... Of course, our ultimate conclusions regarding the legal issues in this matter will require further examination of additional facts that may be presented by the French and by other components of this Department."

Grinstead made clear that, given the outstanding facts, although he was signing off on the Fischinger Report, he did not regard this as the end of the matter:

"... my initialing of this report should not be interpreted as an indication to you, Dr. Mason, or other officials in the Department that I am fully comfortable that the Department would prevail if the French were to proceed to press their claims through litigation."

Grinstead itemized the points on which he believed sufficient information was lacking:

"Our inability to reach such a conclusion does not stem from any inadequacies in Dr. Fischinger's report but rather from our lack of information regarding the details that the French may have to support their claims and from our lack of expertise to fully understand the complex scientific issues that have been raised."

Grinstead concluded his memorandum with a telling observation, the observation of a major deficiency in the U.S. Government's attempt to substantiate its claims:

"One of the factual issues that has not been fully explicated is the development by NCI of the patented invention, i.e., the test kit, prior to the date of the French patent filing in the European Patent Office in September of 1983."

There are several important aspects to the statements by Darrel Grinstead. The first is Grinstead's explicit specification of the "invention" as "the test kit," i.e., not the virus, not the cell line, but the blood test itself. The second important element is Grinstead's specification that Dr. Gallo, in order to establish priority vis-a-vis the invention, would have to be able to show development of the blood test "prior to ... September of 1983."

Yet Lowell Harmison told the Subcommittee he did not even recall seeing Grinstead's memorandum. When Harmison read Darrel Grinstead's memorandum, in 1993, Harmison said the issues raised by Grinstead were further examined by HHS, but Harmison was unable to identify when, how, or by whom this examination was conducted, nor with what results.

Shortly after the IP filed suit against the U.S. Government in the U.S. Claims Court, notwithstanding his concerns and even though no additional supportive information had accumulated concerning the claims of Gallo et al., (indeed, substantial damaging information had accumulated; see below), Darrel Grinstead transmitted the Fischinger report to DOJ, representing it as the authoritative HHS account of Dr. Gallo's research. Thomas Byrnes, the DOJ attorney who was lead counsel for the U.S. defense of Gallo et al., told investigators that in pursuing that defense, he relied heavily on the report.

2. Malcolm Martin's Information:

During the first week of September 1985, several significant events occurred that should have broken wide open the HHS defense of Gallo et al. These events, occurring within the space of just a few days, included the emergence of hard evidence, originating within HHS itself, that demonstrated (1) the strong probability that LAV and HTLV-IIIb were genetically identical, IIIb having been derived from LAV and (2) that Pasteur was not only the discoverer of the AIDS virus, but also, unquestionably, the inventor of the HIV antibody blood test.

The revelation of this evidence should have given rise to a searching examination of the evidence supposedly supporting the claims of Gallo et al. But from the beginning, HHS officials had committed themselves to one thing only -- defending the blood test patent of Gallo et al., and by extension, defending the claimed international political and scientific preeminence of the United States and Dr. Gallo. Facts like those revealed in early September posed a serious threat to the patent and the associated financial and reputational benefits; consequently, the HHS officials who were confronted with these facts ignored and, in some instances, actively suppressed them. This section of the report describes how this occurred.

During the first week of September 1985, the Fischinger report was receiving final sign-offs, even though, astonishingly, Gallo/Popovic's answers to the "three major areas of oversight" identified in Peter Fischinger's August 23 memorandum had not yet been received. Although the Fischinger report was an accomplished reality and HHS was on the brink of informing the IP that HHS had found its claims were groundless, Lowell Harmison decided to canvass scientists in other HHS agencies for information they might have bearing on the validity of the claims of Gallo et al. The reason for Dr. Harmison's decision remains unclear. The absence of all but a few Harmison documents (most of Dr. Harmison's documents vanished when he retired from HHS), together with Dr. Harmison's near-complete amnesia for key events, make it nearly impossible to determine why the belated canvassing was undertaken. But accounts from other participants make clear both what happened during the contacts with Harmison and what happened -- more accurately, what did not happen -- as a result.

Two information-gathering trips were taken by Dr. Harmison and PHS attorney Richard Riseberg. The first trip, on September 5, 1985, was to the NIH campus. The second trip, the following day, was to CDC headquarters, in Atlanta. At NIH, Harmison and Riseberg met with a group of NIH scientists, including NIAID laboratory chief Dr. Malcolm Martin. According to Dr. Martin's account to OSI, he did not know why he was invited to the meeting; he was merely "told to show up." Presumably, Martin's invitation had much to do with his authorship of the March 1985 Cell review, plus his coauthorship of an about-to-be-published article for Science demonstrating the unique genetic identity of LAV and "IIIb" among numerous other HIV isolates and debunking the "geographical proximity" arguments of Gallo et al. (Benn et al., Science, 230, 1985, 949-951).

Dr. Martin told OSI about the discussions at the NIH meeting:

"Initially it was very open-ended: 'What is a viral variant?' I remember that question being asked. After discussing what a viral variant is, the question was -- 'is HIV a variant of HTLV-I?' ... it went on for about three hours. When it was all done Harmison asked the group, 'do any of you have any information that you think is relevant to the origin of HTLV-IIIb or LAV?' I said, probably foolishly, 'yes.' I focused then on genetic variation of the virus at that time. I told him that we were in possession of some information that raised some concerns in our minds about that ..." (8/8/90 OSI interview; annotated transcript pp. 22-24).

The information to which Dr. Martin referred was the data from Dr. Martin's analyses of LAI/LAV, the analyses that showed the presence of the Hind-III polymorph in the virus Dr. Martin received from Dr. Montagnier in April 1984. According to Dr. Martin, Dr. Harmison asked him to write a memorandum describing his results and their meaning. Dr. Harmison promised Dr. Martin the memorandum would be treated "administrative confidential."

What actually happened was that Dr. Martin wrote two memoranda to Dr. Harmison. Dr. Harmison picked up both memoranda in person; neither memorandum was routed through official channels. The memoranda were not produced by NIH to the Subcommittee until nearly two years after the Subcommittee's initial document request; the memoranda were never produced from any official files at HHS. Apparently, the memoranda were never placed in these files, or once placed there, they subsequently were removed. In short, as far as HHS' official records are concerned, it was as if the Martin-to-Harmison memoranda had never existed.

The first of the two memoranda, dated September 6, 1985, included a substantial number of scientific papers and abstracts (including several by Gallo et al.) and related attachments. The memorandum, titled "Discovery of the AIDS Virus," was a wide-ranging one, encompassing (1) Dr. Gallo's early view that AIDS was associated with HTLV-I; (2) what Dr. Martin called "obfuscations" concerning the alleged relationship of the AIDS virus to HTLV-I; (3) a brief description of Martin's LAI/LAV experiments that revealed the existence of the Hind III polymorph and the coincidence of these results with the "IIIb" results of Gallo et al.

Dr. Martin concluded his September 6 memorandum with a reference to the Benn et al. paper, about to be published in Science. Martin summarized the paper's findings as follows:

"... with the exception of HTLV-III and LAV, seven North American and three Zairian AIDS virus isolates are all different from one another" (September 6, 1985 Martin-to-Harmison memorandum; p. 3).

Dr. Martin's closing lines describing the conclusions of Benn et al. were these:

"We offer no explanation for the similarity of HTLV-III and LAV, but informed virologists will certainly draw certain obvious conclusions" (op cit., p. 3).

According to Dr. Martin's account to Subcommittee staff, Dr. Harmison asked him for clarification/elaboration of the information in the first memorandum concerning the apparent genetic identity of LAI/LAV and LAI/IIIb. This led to the second Martin-to-Harmison memorandum, dated September 11. This memorandum, accompanied by several pages of data from Martin's laboratory, added other important details relating to the genetic comparisons of the IP and LTCB viruses, including the fact that, in addition to the Hahn et al. Nature paper showing virus variants identical to those in LAI/LAV also present in LAI/IIIb), the Gallo laboratory had published a second pertinent paper (Shaw et al., Science, 226, 1984). According to Dr. Martin, the Shaw et al. paper described,

"... a molecular clone (HXB2, Figure 1) derived from HTLV-III [IIIb] stocks which contained the aberrant Hind III site in question. This clearly indicates that the Hind III variant is present in HTLV-III [IIIb] preparations" (op cit., p. 2).

Dr. Harmison did not keep his word to Dr. Martin that his (Martin's) memoranda would remain "administrative/confidential." The contents of the memoranda were shared with a number of NCI/NIH officials and scientists, including Dr. Gallo. Among the individuals who reviewed Dr. Martin's data, Dr. Fischinger and Dr. J. E. Rall, the then-NIH Deputy Director for Intramural Research, found Dr. Martin's data impressive. Dr. Rall reportedly said "Mal's arguments are very hard to get around." Dr. Gallo himself told OSI that Dr. Martin's data convinced him both that there had been a "contamination" of the IP and LTCB viruses and that the "contamination" had occurred at LTCB, i.e., the LTCB virus originated with the IP virus, and not the reverse.

Yet within a few weeks, HHS dismissed Dr. Martin's work and suppressed every trace of Martin's correspondence with Lowell Harmison. And within little more than a year, DOJ attorneys would strenuously argue in court assertions such as these:

"... HTLV-III is not LAV by another name" (Defendant's Reply to Plaintiff's Opposition to Defendant's Motion to Stay Discovery, U.S. Court of Claims; 5/19/86; p. 4);

"Continuing research revealed that LAV and HTLV-III were two different isolates of the AIDS virus" (Brief for Appellee, U.S. Court of Claims; 11/13/86; p. 4);

The DOJ attorneys also asserted that the IP suit for breach of contract was,

"... founded on the untenable scientific theory that LAV and HTLV-III are exactly identical" (Brief for Appellee; p. 40).

3. CDC's Information:

At the CDC meeting in Atlanta, on September 6, 1985, Lowell Harmison and Richard Riseberg met with several administrators and AIDS researchers, including Drs. Walter Dowdle, James Curran, and Frederick Murphy. Dr. Donald Francis, who by this time had left Atlanta to work in California, participated in the meeting by telephone. Despite the importance of the Harmison/CDC meeting, only the scantiest records of the meeting exist. Notes of a CDC staffer, headed "Meeting with Lowell Harmison re: French suit for antibody test royalties," include references to Jean-Claude Chermann's February 1984 trip to CDC, during which, by common account, Dr. Chermann's data convinced the CDC scientists that LAV was the cause of AIDS. Shortly after this meeting, the CDC scientists contacted Assistant Secretary of Health, Dr. Edward Brandt, to tell him they were "convinced French LAV was the virus." The meeting notes also reference the CDC comparative serology study, as well as the Gallo/Francis meeting at the IP on April 6, 1984.

Dr. Donald Francis, participating in the meeting by telephone, made his own notes, in his telephone log. Francis' notes for the September 6 meeting included the following entries:

"Lowell Harmison -- conf. call Dowdle, Murphy, Curran, Riseberg. DF -- gave the whole BOW [ball of wax] about French, about Gallo trying to steamroll, about possibility LAV = HTLV-III...

Harmison: 'caution -- call administratively confidential.'"

The first public revelation of the Harmison/CDC meeting appeared in the Chicago Tribune, in a December 31, 1991 story headlined, "In bid to claim AIDS test, U.S. concealed evidence." The Tribune report included accounts of several CDC participants showing how substantial a presentation the CDC scientists made. Quoting CDC scientist Dr. Frederick Murphy and others, the Tribune story said this:

"'A lot was said about the CDC data. There was a full trip through the record, the chronology, with no holds barred. All the data were described.

'They wanted to know who shared what with whom when,' recalled Dr. James Curran, who currently heads the CDC's AIDS research program. 'I remember going through my own notebooks. We told the lawyers anything about this that we had. I certainly didn't hold anything back in my files.'

Dr. Donald Francis, the CDC official who had worked most closely with Pasteur and who had by then been transferred to California, remembered being asked to 'copy all my files' for Harmison.'"

Dr. Francis sent Dr. Curran, who transmitted them to HHS, a vivid letter expressing his views about Gallo's scientific conduct, along with a package containing some of his (Francis') notes, his correspondence with the IP scientists, and copies of a number of CDC/IP collaborative papers.

Dr. Francis spoke candidly in his September 5, 1985 letter, which was especially significant because of Francis' long-term dealings with both the LTCB and IP scientists. Francis began with this:

"I am not familiar with the legal issues being addressed by the French litigation, but there are really important ethical scientific issues that the Public Health Service should consider before putting up a strong defense" (9/5/85 Francis to Curran letter; p. 1).

Francis elaborated on his concerns:

"I am sure that I am not alone in believing that Bob Gallo exceeded ethical bounds in his dealings with the French. If this litigation gets into open court, all of the less-than-admirable aspects will become public and, I think, hurt science and the Public Health Service. The French clearly found the cause of AIDS first and Dr. Gallo clearly tried to upstage them one year later" (op cit., p. 1).

Francis itemized what, in his view, were "the major questions that could come out in public":

"1. Is HTLV-III actually derived from a culture of LAV? LAV was certainly sent to Gallo's lab. The nucleic acid sequences of the two isolates (LAV and HTLV-III [IIIb]) are identical ... No other isolates are identical. Could this occur by chance? Probably not.

1. Did Dr. Gallo practice good scientific ethics regarding this subject? Science must build on the work of others. Gallo was certainly aware of the French work. He reviewed their first paper, co-edited a book with the earliest serologic description and was consulted by phone and in person on multiple occasions. Yet, he was very reluctant to acknowledge their work in his papers and in his presentations. In fact, he actually depricated (sic.) their work. The major question is: did he, in fact, suspect that the two viruses were the same? Before his press conference and his papers he knew the highly unusual morphology of the two isolates was the same. He knew that CDC supplied sera from patients reacted to ELISA antigens in a similar manner..."

Francis continued:

"Even with the knowledge that they were the same virus, he actively prevented the comparison which is required by ethical scientific practices. He was very reluctant to send his virus to Paris. He was reluctant to send it to CDC and only did so after making us promise not to use our comparative assay (RIA) which was the only one available at the time."

Dr. Francis concluded his letter with this:

"With these serious violations of normal practices, we should caution the PHS regarding the defense of the NCI stance."

As for the materials Dr. Francis appended to his letter, it was a remarkable collection, comprising published papers, CDC/IP correspondence, and Francis' own telephone notes and draft letters. The contents of these documents, which substantiated and elaborated the themes of Dr. Francis' September 5 letter, should have produced an immediate understanding at HHS that there were significant concerns about the claims of Gallo et al. But the entire Francis package, together with the other CDC documents, like Malcolm Martin's data, was simply ignored by HHS.

1. "Major Areas of Oversight":

Before describing the fate of the Martin/CDC evidence, it is necessary to examine a memorandum, dated September 6, 1985, purportedly written by Mikulas Popovic, to Dr. Gallo. The Popovic-to-Gallo memorandum, a vitally important one, was ambiguously titled "Origin of H9 Cells." In fact, the memorandum covered far more than the "origin of H9 cells." In addition to a discussion of Popovic/Gallo's rationale for renaming HUT-78 "HT," the memorandum contained an account of the purported "isolation" of "HTLV-IIIb," as well as information on key dates pertaining to Dr. Sarngadharan's earliest work with HIV serology.

The greatest significance of the September 6 memorandum, unrecognized until the Subcommittee's investigation, is that the memorandum contained the responses of Gallo et al. to Peter Fischinger's August 23 memorandum, the memorandum in which Fischinger required Gallo to provide information concerning "three major areas of oversight which have to be completed." These "major areas of oversight," as detailed by Dr. Fischinger, were as follows:

-- "The derivation of the H9 cell line traced to its parental origins, i.e., the patient."

-- "The exact sequence and timing of the events which led to the virus-producing line HTLV-IIIb that is now in current use. This is considered to be is (sic.) very critical ... We need an oral description as well as copied pages from relevant notebooks. We would like a written statement from Dr. Popovic, and whoever else partook in the development of the HTLV-IIIb line, that LAV was never used in any connection in that complex infection sequence which led to the isolation of the HTLV-IIIb line (emphasis added)."

-- "It is important to define the first time when ELISA's or Western blots were attempted with any HTLV-III-type isolate and human patient sera."

The September 6 Popovic-to-Gallo memorandum responding to Fischinger's queries, contained a number of false and misleading statements. According to Dr. Popovic, Dr. Gallo personally edited Popovic's draft of the September 6 memorandum. A copy of the memorandum exists with edits in Dr. Gallo's hand.

Among the more significant inaccuracies in Dr. Popovic's September 6 memorandum are the assertions that:

-- "Since primary non-cultured HUT-78 cells are not available, we cannot make a definitive conclusion whether the designated HT cells are identical with the original HUT-78 or not."

Dr. Popovic's premise was not correct. Primary HUT-78 cells were available. Dr. Popovic made no effort to contact Dr. Adi Gazdar, whose cell line HUT-78 was, neither did Popovic seek HUT-78 from the ATCC. Had Dr. Popovic sought HUT-78 from either source, he would have readily been able to "make a definitive conclusion" about the identity of H9 and HUT-78. Indeed, that is what happened in 1988-89, when by order of the NIH Director, the testing was finally done.

-- "Months after our publication Montagnier with CDC published production in a cell line for the first time. They used BJAB, a B-cell line heavily contaminated with squirrel monkey retrovirus."

As noted above, Gallo/Popovic's claims that the IP cell line was contaminated with a squirrel monkey retrovirus were entirely without foundation. Dr. Gallo finally admitted this to Subcommittee staff, in the Summer of 1993.

-- Most important of all, the September 6, 1985 Popovic/Gallo response concerning the "isolation" of IIIb both contained several significant misrepresentations and was a significant evasion of what Dr. Fischinger had asked. The memorandum cited the use of at least one sample that, according to LTCB records, was not available at the LTCB at the time of its alleged use for the "pool" experiment. In addition, what is most noteworthy is what Dr. Popovic said about his use of the IP virus, relative to his "isolation" of IIIb:

"The development of H9/HTLV-IIIb was almost entirely confined to the tissue culture room 6B03A where no LAV was ever used" (emphasis in original; op cit., p. 2).

Dr. Popovic's statement completely evaded Dr. Fischinger's request for a formal statement that he (Popovic) did not use the IP virus for the isolation of "IIIb." Dr. Popovic did not provide the assurance Dr. Fischinger sought. Moreover, what Dr. Popovic did say was significantly problematic, on several counts:

1. Dr. Fischinger asked for a blanket statement that LAV "was never used in any connection ... in the infection sequence" that resulted in IIIb, but what Dr. Popovic said was merely that the isolation of H9/IIIb took place in a room where no LAV -- allegedly -- was used. By Dr. Popovic's own account, the H9/IIIb cell line was not developed until at least mid-January 1984. Thus, Popovic's response failed to account for the first two months of the reported existence of IIIb, which took place in a room (6B22) where LAV was frequently used.

2. Dr. Popovic's statement that "no LAV was ever used" in Room 6B03A (of Building 37) is subject to question. By Popovic's own account, he thawed LAV and used it (late January/early February, 1984) for his "host range" experiment. So far as is known, at this time, Popovic's only laboratory space was 6B03; so if the "host range" experiment really was carried out, it almost certainly was done in 6B03.

3. Dr. Popovic qualified his response to Dr. Fischinger's question by the phrase "was almost entirely confined to" rather than "entirely confined to," thus indicating Popovic was leaving himself some leeway in his response. The words "almost entirely" should have alerted Dr. Fischinger to the possibility that Dr. Popovic was unable or unwilling to give an unconditional assurance that he did not use LAV in "isolating" IIIb.

4. Dr. Popovic failed to give Dr. Fischinger a straightforward affirmation that he (Popovic) did not use LAV to isolate IIIb. The curious statement Dr. Popovic did make, concerning the room in which H9/IIIb allegedly was isolated, was so clear an evasion that Dr. Fischinger should have recognized it at once and sought the reason for Popovic's evasiveness. There is no indication Fischinger did anything of the sort.

   -- "The first antibody against HTLV-III was obtained by Dr. M. Sarngadharan on December 13, 1983, and the first ELISA was performed by him on January 6, 1984" (op cit., p. 2).

    

It is important to note that Dr. Fischinger's August 23 query about the LTCB HIV blood test was itself deficient. Dr. Fischinger failed to ask the identity of the HIV isolate used for the LTCB blood test; Dr. Fischinger also failed to ask for and inspect any laboratory notes relating to the blood test. Drs. Popovic and Gallo did not supply any information on the identity of the isolate, which as previously described, was LAI/"MOV," neither did they reveal that the serum they used as the AIDS standard for their initial ELISAs was from patient BRU. Moreover, the information Popovic/Gallo did supply was incorrect and misleading in several significant respects, particularly in regard to the claim that "the first antibody against HTLV-III was obtained ... December 13." There is no known basis for this claim. Development of the rabbit hyperimmune antiserum, a polyclonal antibody, was not even initiated until December 29; the antiserum was not available for use until February 24, 1984. As for the ELISAs, the January 6 date appears to be correct, but what Popovic/Gallo failed to tell Fischinger was that the LTCB ELISA did not work satisfactorily until the end of January 1984.

Given Dr. Fischinger's very limited knowledge of the facts (not to mention his evident determination not to know them), it is unlikely he would have recognized the misrepresentations in the September 6 Popovic/Gallo memorandum. Dr. Fischinger could and should have recognized well the memorandum's evasions of his questions. But there is no indication Fischinger did recognize the evasions or, if he did, that he did anything about them.

5. Disposition of the Martin and CDC Information:

As for the CDC and Malcolm Martin materials, the former items made their way to HHS and ultimately to DOJ, but very belatedly. The Francis-to-Curran letter, together with the appended documents, was sent by Richard Riseberg to Darrel Grinstead, but not until January 24, 1986, four and one half months after the letter was written. Once the Francis materials reached Grinstead, they apparently went nowhere. Grinstead told Subcommittee staff he did not know if the Francis materials were transmitted to DOJ; the Subcommittee staff's review of the DOJ files of attorney Byrnes revealed none of the Francis documents. But the documents obviously resided at HHS from 1985 to 1992, when they were officially provided to the Subcommittee.

In November 1992, when he was interviewed by Subcommittee staff and shown the Francis materials, James Curran's response revealed his frustration at HHS' evident disdain for CDC's information:

"We at CDC never tried to encourage the United States to support the Gallo patent. They had Don's stuff -- they had it all this time" (11/19/92 interview).

What was found at DOJ was extremely significant, i.e., a copy of the CDC computer print-out of the comparative serology data -- the data showing the equivalent performance of the IP and LTCB blood tests. Subsequent to the Subcommittee's discovery of the computer print-out in the DOJ files, DOJ officials refused to make attorney Thomas Byrnes available for a Subcommittee staff interview. Consequently, it was not possible to determine when and how Mr. Byrnes obtained the CDC data, whether he understood their significance, why he failed to act on the obvious implications of those data, and most important, why he continued to submit legal pleadings whose contents was refuted by materials in his own files.

Concerning Malcolm Martin's memoranda and data, one important question that remained unanswered for years was what, if anything, Harmison did with those items before they vanished from the official record. Finally, in late 1992, when Dr. Gallo gave up documents from his laboratory, documents withheld from the Subcommittee since early in the year, the answer was revealed, for almost as soon as he received the memoranda from Malcolm Martin, contravening his assurances to Martin that he would keep the materials confidential, Lowell Harmison sent copies of the memoranda, together with (at least) the data attached to the September 11, 1985 memorandum to Peter Fischinger. Fischinger in turn, sent them directly to Dr. Gallo.

Evidence of these events came from a package of documents provided to the Subcommittee from the LTCB in November 1992, well after Dr. Gallo had affirmed in writing that he had provided all documents responsive to the Subcommittee's document requests. Among these documents was a copy of Martin's September 11, 1985 memorandum to Lowell Harmison, accompanied by Martin's laboratory data. Martin's name had been deleted from the top of the memorandum, but as described below%%, Dr. Gallo obviously knew the memorandum's source.

Penned across the top of the September 11 Martin memorandum, in Peter Fischinger's hand, was this note written to Dr. Gallo:

"This information was transmitted to us from Dr. Harmison OASH to help you formulate a precise answer. PJF."

Someone, most likely Gallo, marked the contents of the memorandum as he read it. Two passages of the memorandum were underscored by hand, the two key passages that told Gallo what Dr. Martin had found:

"... we concluded that at least two viral variants were present in the LAV virus stock we had received from Dr. Montagnier in late April 1984" (emphasis added by reader).

"Two viral variants" and "late April 1984." These were the critical items that told Dr. Gallo, who hardly needed to be told, that (1) his virus was genetically identical to the IP virus and (2) his virus was derived from the IP virus and not the reverse (because Malcolm Martin's LAV was obtained from Paris well before Gallo sent IIIb to Montagnier).

Rather than convening an independent panel of experts or otherwise attempting to deal responsibly with Malcolm Martin's data and the information obtained from CDC, HHS turned once again to Dr. Gallo. Peter Fischinger wrote yet another memorandum. In this September 10, 1985 memorandum, Dr. Fischinger told Dr. Gallo that based on discussions "... emanating from our compilation of your data," a letter had already been sent to the Institut Pasteur,

"... stating that the position and the resulting claims of the Institut Pasteur were not supportable" (9/10/85 Fischinger-to-Gallo memorandum; p. 1).

Dr. Fischinger's memorandum did not mention Lowell Harmison's trips to NIH and CDC, rather the memorandum described a scenario (that apparently did not occur) in which, according to Fischinger, his report was sent to HHS agencies other than NCI engaged in HIV research, so that:

"... any other intra-departmental concern, which would be incongruent with the position outlined by NCI, would be voiced and answered" (op cit., p. 1).

Fischinger told Gallo that, as a result of this "critique" process:

"There was some consensus on a number of issues. However, several additional concerns (were) raised which related to both the flow of HTLV-III-oriented research in your laboratory and referred to the possibility that there might have been a common origin of the presently analysable LAV and HTLV-IIIb virus stocks" (op cit., p. 1).

Dr. Fischinger asked Dr. Gallo to respond to several questions,

"... raised by the NIH/HHS legal counsel in order to arrive at a final departmental position."

The questions in Peter Fischinger's September 10 memorandum are noteworthy, both because of their avoidance of the central issues raised by the CDC scientists and Malcolm Martin, and because of the "coaching" they reflected. The first four questions, aimed at encouraging Dr. Gallo to elaborate on the putative "continuity" of his work, while at the same time denigrating the IP work, were as follows:

"1. Since you demonstrated in November-December 1982, the presence of a virus which clearly did not seem to be HTLV-I or II, why was this fact never mentioned in your many ensuing publications over the next year? Ostensibly, all of the papers mention the HTLV-I association with AIDS, but none address the fact that you were aware of the existence of other agents which were of the HTLV-III type.

2. Would it be possible to establish a flow of continuity of your thinking and experiments in your laboratory on the non-HTLV-I isolates from your first idea to May 1984? Had you abandoned the experiments searching for a non-HTLV-I agent between December 1982 and June 1983?

3. What was the progression of your thinking and experiments leading to the successful HTLV-III ELISA tests? When did you and/or your contractors first apply the ELISA technology to human AIDS/ARC sera in conjunction with an HTLV-III type isolate? Did the Biotech contract use your input and technology to develop their August 25 [1983] patent application, which appears to claim to have had a generic ELISA test for all HTLVs, including those in AIDS? Did Biotech work with any of the early HTLV-III transmissible isolates in 1983?

4. According to some researchers, the first clear linkage of LAV to AIDS was accomplished by Dr. Chermann at the Park City, Utah meeting in February 1984, rather than your May 4 Science papers. Would you comment on the extent and the surety of information presented at that meeting by the French team?" (op cit., pp. 1-2).

The fifth question Fischinger posed -- the question pertaining to Malcolm Martin's LAV experiments -- was prefaced by a lengthy introduction, a nearly verbatim excerpt from Martin's September 6 memorandum to Lowell Harmison. Fischinger recognized well the seriousness of Martin's data and their implication. Fischinger said this to Gallo:

"Because of the scientific nature and the nonscientific implications and seriousness of the next concern, the allegation below is presented in almost verbatim form. The scientist's name is not mentioned" (op cit., p. 2).

Following the excerpt from Malcolm Martin's memorandum that described the molecular identity of the IP and LTCB viruses, Dr. Fischinger concluded his memorandum to Dr. Gallo with this series of questions:

"Could you discuss the possible origins of such a common 'contaminant' virus? Based on known sequence differences of LAV and HTLV-IIIb, can one jump to conclusions (emphasis added) of identity (emphasis in original) of this second species in the LAV and HTLV-IIIb stocks, based only on (emphasis added) restriction endonuclease patterns? Have you seen more than one virus in any of your > 100 isolates if you did not purposely infect with virus from more than one individual?" (op cit., p. 3).

Fischinger's concluding instruction to Gallo also was highly revealing, implying as it does a clear admonition that Gallo was not to "rock the boat" with his response:

"The Department requests a prompt reply to these questions so the previously outlined position is satisfactory to the Office of the General Counsel" (emphasis added; op cit., p. 3).

6. Dr. Gallo's Response:

Dr. Gallo's September 23, 1985 reply memorandum to Peter Fischinger was a key document in the French/American dispute. The memorandum was sent to the Department of Justice, where the attorneys representing the United States Government in defense of Gallo et al. incorporated a number of the memorandum's assertions into U.S. Government pleadings. Both Fischinger's September 10 request memorandum and Gallo's response memorandum made their way to the Office of the Director, NIH, and to a number of HHS officials and attorneys. The memorandum is notable both for its candor on one key issue, i.e., "early isolates" (see above) -- candor dramatically at odds with Dr. Gallo's statements on the same issue on other occasions -- and for its extravagance, exaggeration, and clearly wrong information on other key issues.

The latter such statements included the following:

(1) "Remember, at this stage [March 1983 to the Fall of 1983] the Pasteur group had one claim of one virus and they reported that it was significantly cross-reactive with HTLV-I ..." (emphasis in original; op cit., p. 2).

"In the May 1983 papers (sic.) Montagnier and co-workers stated their virus was an HTLV. They showed a cross-reaction- with HTLV-I. Clearly the virus was human T-lymphotropic virus, as they said" (emphasis in original; op cit., p. 5).

As described above, these incorrect perceptions of the AIDS virus as related to the leukemia virus were Dr. Gallo's own, not those of the IP scientists.

(2) "It was not until our November 1983 breakthrough on mass production of HTLV-III were any specific reagents made enabling us to link the virus to the cause of AIDS" (op cit., p. 1).

This statement failed to reveal that the LTCB's November 1983 "breakthrough" was achieved with "MOV," and not with "IIIb," with H4 and not H9. More importantly, the statement clearly implied that HIV-specific reagents were created in November 1983 or very soon thereafter, when in reality, the first such reagent was not prepared until late-February 1984.

(3) "We did our first test in December 1983 with bona fide mass-produced HTLV-III ... We did not test sera by ELISA with non-mass-produced viruses because quite obviously the results would be crappy. The Pasteur group elected to do so; ie., they used the few virus particles transiently released on the dying primary blood T-cells and that is why they got such inclusive results" (op cit., p. 2).

There are a number of misleading aspects to the above passage, which addresses one of the central issues in the blood test patent dispute. The LTCB ELISA was not even attempted until January 1984, and it was not until the end of January that the test reportedly performed satisfactorily. Moreover, as noted above, the initial LTCB ELISAs were all performed with LAI/MOV, which Dr. Gallo described as "mass-produced HTLV-III."

As for the assertion that the IP's blood test results were "inconclusive," the IP results, in fact, were fully as good as those of Gallo et al. (see above).

(4) Attempting to rebut the Martin/CDC assertion that the IP results, as of the February 1984 meeting at Park City, Utah, constituted "the first clear linkage of LAV to AIDS," and thus, predated the LTCB data published in May 1984, Dr. Gallo said this:

"Even if the above three points did not matter, the conclusion would still be erroneous since 1) I had already lectured at the Pasteur Institute in Paris in January 1984 and told a very extensive audience I was sure we had the cause of AIDS by numerous virus isolates plus wide seroepidemiology with 90 to 100% linkage to ARC and/or AIDS depending on which of many already completed studies we quoted. In a private meeting with Dr. Chermann and Montagnier I gave many of these details. 2) Also in January 1984 I called Jim Curran and requested a large panel of CDC sera ... to be sent to me 'blind' (all our testing was and still is done with coded sera). I told him then I was sure we had the cause of AIDS and that it might be the virus identified in the lymph node patient by the Montagnier group. Obviously, to tell Jim Curran this meant that we already had the data and simply wanted to convince him. Sera were sent some weeks later. At the beginning of March 1984 Jim Curran, my collaborator Dr. Sarngadharan, and myself met for lunch at LaMiche in Bethesda. The code was broken and verified our conviction. It was also at this time that I let NCI officials know: a) the etiology was conclusively solved and b) we had developed a real blood test for this virus. No one in the world ever made these claims before this time" (emphasis in original; op cit., pp. 3-4).

At least three major events are misrepresented in the above passage, both with respect to the timing of their occurrence, and with respect to what took place. In every instance, the events were purported to have occurred earlier than they actually did, in one instance, by a matter of several months. Specifically:

(a) Dr. Gallo visited Paris and lectured at the Institut Pasteur in April, not January 1984 (see above); Dr. Gallo met with Dr. Francis as well as other scientists, and during this meeting, Dr. Gallo saw the CDC comparative serology data indicating LAV, like "HTLV-III," was the cause of AIDS.

(b) Dr. Gallo telephoned Dr. Curran in mid-February 1984, after he (Gallo) heard Chermann at the Park City meeting, not in January. Dr. Gallo could not have told Curran during the telephone call he was "sure" he had the cause of AIDS. At the time the call was made, Gallo et al. still had no HIV-specific reagents and still had not performed what Gallo himself would describe as the "critical" serology (see above; 5/10/90 MOV Submission to OSI; p. 2).

(c) Dr. Gallo and Dr. Curran did not meet at the Bethesda restaurant "at the beginning of March." The meeting took place on March 12 (see above). Moreover, during this meeting, Dr. Gallo learned that the IP LAV blood test performed as well as the LTCB's test in detecting viral antibodies in AIDS and pre-AIDS patients.

(5) Dr. Gallo attempted to deal with the obvious implications of Malcolm Martin's data, what Gallo termed "the unfortunate innuendo," using several different arguments:

(a) "Our laboratory had multiple isolates from the beginning and we were the first to discover heterogeneity among isolates from analyses of the genomes of some of these (published first, in fact, in 1984 from data originated in December 1983)" (op cit., p. 4).

Concerning the LTCB's putative "multiple isolates," 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; op cit., p. 5).

The facts are otherwise. Gallo et al. did not isolate RF "at exactly the same time" as LAV; RF was not cultured at all until November, 1983. It was not co-cultured with HUT-78 cells until mid-December, and this event occurred because the RF primary culture was "dying rapidly." The LTCB scientists did not attempt to infect H9 with RF until June, and as noted previously (see above), they had to repeat the infection in July; they did not patent RF at any time. The false claims relating to the PNAS paper have already been elaborated in detail above (see above).

Besides the previously-discussed irrelevance of the LTCB's alleged "other isolates" to the issue of whether or not LAV and IIIb were identical, the above passage is noteworthy for the false claim that Gallo et al. possessed molecular data "originated in December 1983." There is no basis for this claim, as Gallo admitted to Subcommittee staff in July 1993.

(b) Dr. Gallo identified three instances in which HIV isolate pairs had been found that allegedly were as close as or closer to each other than were LAI/LAV and LAI/IIIb. Two of these instances were recounted only anecdotally by Gallo; no substantiation for the claims is known to exist. As for the third instance, the instance of MN and SL, this instance later was ascribed by Dr. Gallo to a "mix-up of samples" (4/27/90 OSI interview; transcript p. 76).

(c) Dr. Gallo's response to Fischinger's query, "Have you seen more than one virus in any of >100 isolates if you did not purposely infect with virus from more than one individual?" is not comprehensible. However, it is notable that: (1) Dr. Gallo admitted the presence of the same multiple virus variants in both LAI/LAV and LAI/"IIIb"; and (2) Dr. Gallo acknowledged that the variants in both LAV and IIIb could represent "polymorphic variants generated in vivo." Yet Dr. Gallo still invoked the geographic proximity argument, in an effort to make the case that LAI/LAV and LAI/IIIb, although they shared two identical viral variants, could still be of independent origins:

"If LAV and HTLV-IIIb are similar because they are derived at the same period of time from New York at a time only shortly after the virus entered the U.S., then all the polymorphic variants would also be expected to be highly related."

Dr. Gallo's implied argument that geographical and temporal proximity could have accounted for the identity of LAV and IIIb is both factually and logically flawed. In the first place, there was no evidence showing that "IIIb" was "derived from New York." Some of the samples allegedly used for the IIIb "pool" came from New York, but several did not, and as Gallo himself stated,

"... it is hard to know which or how many viruses [if any] actually took."

There was even less substantiation for the assertion that LAV and IIIb were "derived ... at a time only shortly after the virus entered the U.S." The first AIDS cases in the United States were reported in 1981, while LAV/BRU and the putative "IIIb" samples were obtained in 1983. Considering the well known, extraordinarily rapid mutation of the AIDS virus, it was rank speculation to assert that by 1983, isolates as alike as the IP and LTCB viruses could be anything other than commonly derived.

In addition, the implied assertion that LAV and IIIb could be independent and still contain "polymorphic variants ... highly related," could not hold water. What Malcolm Martin's data showed was that not only the dominant virus in LAV and IIIb was identical, but the secondary virus was identical as well. Moreover, the viral variants were present in the two putative independent isolates in substantially the same proportions. What Dr. Gallo was trying to argue was that two independent events produced two identical products, in the same relative quantities, an argument that was scientifically and logically incredible.

Elsewhere in the memorandum to Fischinger, Dr. Gallo invoked the argument that the variant viruses in IIIb could be associated with the pooling of several patient samples, in the process making vague allusions to a possible appropriation of "his" virus by the IP:

"As an alternative interpretation of point 4: There are several proviruses in the H9/HTLV-IIIb cell line. We stated in our paper we used samples from several patients. Montagnier used only one patient. When analyzing virus from a single patient at any one fixed time we found only one form. How did Montagnier get more than one form?") (op cit., p. 5).

(d) Still attempting to refute Malcolm Martin's data and conclusions. Dr. Gallo said this about September LAV:

"We received an extraordinarily small amount (11,000 CPM reverse transcriptase) of Montagnier's virus September 24, 1983. Mika developed the clone H9 in early November 1983. Can anyone possibly imagine mass production of this amount of virus in five weeks?" (op cit., p. 5).

This statement contains the notable inaccuracy that H9 was created in "early November 1983," an error of two and one-half months. Equally significant is the implied assertion that it would have been impossible for Popovic, in November 1983, to productively infect a permanent cell line with September LAV. In fact, that is precisely what Dr. Popovic did. Dr. Gallo knew this. He wrote, in the Popovic paper, that LAV grew in H4. Dr. Popovic knew it well. He told OSI that LAV grew "very well" in permanent cell lines. Dr. Fischinger could have known it, had he only asked for the LTCB's LAV data. But Fischinger did not ask, and Gallo/Popovic did not tell. Thus the falsehoods about the impossibility of productively growing September LAV lived on.

(e) Finally, concluding the September 23 memorandum, Dr. Gallo said this: "... once we characterized HTLV-III (by December 1983) we never claimed anywhere that it was closely related to HTLV-I" (op cit., p. 6). The dubious quality of the claims about the relationship of "HTLV-III" to -I and -II has already been discussed. Even more problematic is the claim in the above passage that the LTCB scientists had "characterized HTLV-III" by December 1983. Dr. Gallo acknowledged to Subcommittee staff that this claim could not be substantiated. Even LAV, by far the best characterized isolate at the LTCB by December 1983, could not credibly be described as "characterized ... by December 1983," in the usual meaning of the term.

6. Dr. Gallo's Explanations:

Considering the significance of the Popovic/Gallo August/September 1985 memoranda to the subsequent U.S. defense of Gallo et al., and the clear evidence that those memoranda contained numerous misstatements and reflected numerous material omissions, it is instructive to see how Dr. Gallo views his own role in these matters.

During his July 1993 interview with Subcommittee staff, Dr. Gallo was asked about the documents he transmitted to Peter Fischinger, during Fischinger's brief "investigation," and about the "Fischinger report" itself. Faced with the statement he signed affirming the accuracy of the statements contained in the report and affirming that they were supported by data, Dr. Gallo acknowledged, "Yes, I signed it." But Dr. Gallo added,

"I didn't read it [the report] as carefully as you might think."

Attempting to explain his claimed indifference to his attestation of the accuracy of the report, Dr. Gallo said this:

"I didn't even know what was going on. They didn't tell me about the meeting with the lawyers that day" (7/22/93 Subcommittee staff interview).

In fact, Dr. Gallo was told about the "meeting with the lawyers," in Peter Fischinger's August 7 memorandum to him. Shown this memorandum, in July 1993, Dr. Gallo responded,

"Oh well, you're right. But it doesn't change my mood too much. My first involvement with the story was not medical or scientific" (op cit.).

Dr. Gallo described the basis for the information he transmitted and the statements he made to HHS as "a memo from Mika" that summarized his (Popovic's) experiments. But, said Gallo:

"You just give up science-- you can't look at every last thing. He told me in a memo. Mika said he got temporary growth [of LAI/LAV] in HUT-78" (op cit.).

Otherwise, Dr. Gallo said, "I don't know what I relied on." Yet Dr. Gallo also said, concerning his sources of information, that he "would have" relied on Popovic, Read-Connole ("on specific things") and Sarngadharan. Dr. Gallo said:

"I probably called a meeting. Boy, I don't know. Maybe I called him [Dr. Popovic] back up on the phone. I don't know" (op cit.).

Dr. Gallo added this:

"Lowell (Harmison) must have talked to me about this. At the very beginning I was just meeting him. If problems occurred, I'd see him -- more and more. He'd come visit me many times. He's been in the lab and he's talked to people in my lab many times without my being there" (op cit.).

(This statement by Dr. Gallo directly contradicts Dr. Harmison's sworn testimony concerning his contacts with Gallo; see below.)

Concerning who selected and assembled the data he provided to Dr. Fischinger, Dr. Gallo said this:

"Mika would refuse outright. He doesn't like administrative ... This would be Ann [Slisky] or Prem [Sarin]" (op cit.).

Dr. Gallo described his attitude in responding to Fischinger's questions in August and September of 1985; he attempted to account for the several incorrect statements in his September 23, 1985 memorandum to Peter Fischinger. Concerning the claim that "... we did our first test in December 1983 ...," Dr. Gallo acknowledged this could not refer to the LTCB ELISA.

"I wasn't thinking about a patent. I don't know. If the ELISA was in January, this must be immunofluorescence. But it would be small in amount, and non-definitive" (op cit.).

Responding to questions about the claims in the memorandum that "... we isolated, mass produced in H9 cells, patented and published ..." on RF "... at exactly, the very same time ..." Dr. Gallo admitted that "'mass produced' is not the right phrase," but he argued it was proper to say he had "patented" RF, merely because it was one of the examples shown in a table of one of the patent applications.

In sum, concerning the statements in the memorandum about "RF," Dr. Gallo said,

"No one should care about this ... It could have been true; we could have mass produced it at Frederick" (op cit.).

As previously described, there is cause to question what could have been done with RF. Even allowing for the possibility that RF possibly could have been "mass produced," this does not change the reality that it was not, contrary to what Dr. Gallo claimed in his memorandum to Dr. Fischinger.

Even Dr. Gallo boggled at the statement in the memorandum that he had "characterized HTLV-III" by December 1983. The best Dr. Gallo could do in defending the statement was to say, "It would have been mostly serological." But serological studies do not constitute virus characterization; the statement written in the memorandum was not true.

Finally, offering an account of his emotional state as he wrote the September 23 memorandum, an attempted explanation for the extraordinary statements the memorandum contains, Dr. Gallo said this to Subcommittee staff:

"I'm sky-high writing this thing. It's the first time my integrity is being doubted. I was infuriated ... My emotions were to get this out of my life ... I responded with fulminating anger" (op cit.).

E. Key Players at HHS

HHS' September 6, 1985 rejection of the IP demands did not close the door entirely on discussions with IP representatives. Further correspondence between Mac Haddow and Professor Dedonder, during September and October 1985, led eventually to discussions in Washington between HHS (with attorney Darrel Grinstead playing a leading role) and one of the U.S. firms representing the IP's interests, Weil, Gotshal & Manges. But even as the attempted negotiations moved ahead and, eventually, collapsed, both sides were preparing for the possibility of litigation.

To understand HHS' actions in 1985 and thereafter, it is useful to examine what key players told the Subcommittee staff they believed they were doing, and why, relative to the French/American dispute. Several themes emerged from the statements of these individuals, including prominently, denial of responsibility, even on the part of officials who, according to the documentary record, clearly played key roles in the HHS/U.S. response to the IP challenge.

Concerning the substance of the U.S. response, it is clear that the overriding concern at HHS was never "should we defend the Gallo patent?'; rather, at all times the concern was how to defend the patent. No one, it appears, asked the question, "What is the truth about the claims of Gallo et al.?" No one, it appears, ever asked, "What is the right thing to do?" Indeed, from the testimony of some witnesses, it became clear that even when HHS began to suspect Gallo's claims could not be substantiated, HHS still was determined to actively defend those claims for as long as possible, by whatever means possible, while at the same time negotiating a settlement that would be as favorable as possible to HHS and the United States.

(1) C. McLain Haddow: The individual who first described the HHS stance with particular clarity was C. McLain Haddow. Haddow played an active role in the dispute in 1985. As Margaret Heckler's Chief of Staff, Haddow communicated frequently with IP officials, denying strongly the validity of the IP claims. Yet in 1990 and thereafter, Haddow asserted he had been suspicious of the claims of Gallo et al. all along. Haddow spoke out first to the Chicago Tribune, where he was quoted on March 18, 1990 as follows:

"'There was a point where it became very clear to me that the NIH people were not being truthful,' Haddow recalled. 'These people would sit down for one meeting and then in a subsequent meeting the stories were different ... They weren't even smart enough to get their stories straight before they talked to me,' he said. 'How in the world could they get through a court proceeding?'" (p. 16).

Because Mac Haddow is a convicted felon, his testimony might be subject to some question. However, much of Haddow's information was independently confirmed by documentary evidence, as well as testimony of other witnesses, including one of Haddow's top assistants, a career civil servant of unchallenged integrity.

Haddow recounted to Subcommittee staff meetings and telephone calls with Gallo. Haddow recalled one meeting in which Gallo adamantly recited his claims, and becoming heated, pounded the table and asserted Haddow was trying to deprive him of a Nobel prize. According to Haddow, when Gallo left, Haddow's assistant remarked of Gallo, "He's lying through his teeth." Haddow's assistant substantially confirmed Haddow's account, telling investigators that Gallo provided "personal assurances of the integrity of his work," including the fact that, he said, the LTCB scientists always kept LAV separate from the LTCB's own cultures. But, according to Haddow's assistant, "it was difficult to believe him." Haddow's assistant recalled making a remark, "He's lying," or "Something's rotten in the state of Denmark," or similar.

According to Haddow, the HHS attorneys believed they could sustain a defense for some time, based on Gallo's strong statements and the fact that he had the support of the entire NIH leadership. But the HHS attorneys were not confident that HHS would win if it came to a showdown.

Haddow's assistant said there was:

"... a general impression that we wouldn't win, because Gallo lacked documentation to show there was no use of the French virus, and thus could not refute the main French accusations" (10/92 interview with the HHS OIG).

According to Haddow:

"... so our attorneys recommended, the Department attorneys, perhaps in some conflict with the NIH attorneys, recommended that we fold, that we roll over but play it out until we saw how strong the French were on it but our strategy was play it out as strong as we could but if we got to the point where we knew we were going to court that we should roll over and accept a reconciliation and settlement of this problem. The French attorneys, the attorneys representing the French government, didn't know how weak our case was and they never discovered it. We were able to craft an agreement that probably disadvantaged the French, but it was because we hid our weakness fairly effectively" (BBC interview; broadcast in "Taking the Credit," May 11, 1992).

In an interview with The New York Times, Haddow echoed both his statements to the BBC, as well as the account of his former executive assistant. According to the Times:

"The officials at Health and Human Services 'believed that Gallo was incorrect when he said he did not use the French virus,' Mr. Haddow said. 'There was some question about the significance of the use, but they were aware that it had been used in some fashion. Their recommendation was to play it out as best we can, and if we can get a settlement where we share the credit, let's do it'" (The New York Times, 6/25/92).

(2) Dr. James Mason: Dr. James Mason dealt with the French/American dispute from a unique perspective. At the time of the April 1984 HHS press conference, Mason was serving as Director of the Centers for Disease Control. As CDC Director, Dr. Mason presided over an agency that attempted behind the scenes -- largely unsuccessfully -- to prod HHS into giving rightful credit to the prior discoveries of the IP scientists.

Dr. Mason actually put his job on the line by speaking out with the truth. But during the blood test dispute, as Acting Assistant Secretary of Health (ASH), Dr. Mason was more subdued, possibly because, as he told the Subcommittee staff, in 1985, he "was led to believe we had a very strong case" (9/10/93 Subcommittee staff interview). In this regard, Mason said he relied on individuals such as Lowell Harmison and Darrel Grinstead for his information about the dispute. Mason acknowledged to Subcommittee staff that rather than accepting the assurances of his subordinates, he should have investigated on his own whether the claims of Gallo et al. were defensible. "It would have been a good idea to do that," he said. But Dr. Mason did not.

According to Dr. Mason, despite what he was told about the "very strong case" of Gallo et al., he was concerned with the issue of fairness to the IP vis-a-vis the patent royalties. Mason in fact was in the forefront of those who urged Secretary Heckler to continue to negotiate with the IP representatives, to determine if an equitable agreement could be reached.

Dr. Mason told Subcommittee staff that because of the repeated assurances he was given about the U.S. Government's "very strong case," he was greatly surprised when he learned the Government had entered into a settlement agreement with the IP. (Mason returned to his permanent position as CDC Director by the end of 1985, long before the agreement was signed in March 1987.)

Mason said that sometime after the settlement was signed, he encountered Robert Charrow, a key player in HHS' response to the dispute, beginning in 1986. Dr. Mason said he asked Charrow why, if the U.S. case was so strong, the United States Government had agreed to a settlement in the dispute. According to Dr. Mason, Charrow responded with this:

"'Gallo's laboratory notebooks were in such disarray, we were not sure we could defend the position'" (op cit.).

(3) Darrel Grinstead: Prior to Robert Charrow's arrival on the scene, Darrel Grinstead was the top HHS attorney dealing with the French/American dispute. Grinstead's perspective on the dispute, as described to Subcommittee staff and substantiated by the documentary record, diverged sharply from that of Lowell Harmison on several fundamental issues. Most notably, Grinstead said the two central legal issues in the dispute, in his view, were 1) the isolation of the virus and 2) the reduction to practice of the HIV antibody blood test. Grinstead 's belief that the isolation of the virus was a central issue is noteworthy, particularly in light of Lowell Harmison's adamant insistence, which HHS maintains to this day, that the discovery of the virus was immaterial to the French/American dispute.

Mr. Grinstead also displayed a pervasive absence of any sense of responsibility for HHS' actions. But meeting notes and correspondence contemporaneous with the dispute make clear that Grinstead was importantly involved in virtually every meeting and event, particularly during the first half of the dispute.

Grinstead at least was candid in his description of what HHS was attempting to accomplish in the dispute:

"I think there was a motivation to come up with support for the patent."

Grinstead said he believed the monetary aspects of the dispute were "trivial" to HHS. Far more important, he said, was "scientific pride," which Grinstead called "positive pride".

Asked who gave him the minimum terms for a resolution of the dispute, Grinstead said he did not remember what he was told about terms, and,

"I wouldn't tell you even if I did -- it was between client and attorney."

Asked who his client was, Grinstead responded that Lowell Harmison was "my most regular client." Grinstead added that Harmison "... had been the driving force from the beginning."

Mr. Grinstead acknowledged he was the principal patent attorney at HHS at the time of the French/American dispute; his responsibility, Grinstead said, was to,

"... determine if our position in court is defensible" (9/22/92 Subcommittee staff interview).

Yet Grinstead actively rejected any investigative role for himself or his office; Grinstead said he "expected the information to come to me." Grinstead also claimed it did not occur to him that the Gallo patent actually was in jeopardy. He asserted it was "not unusual to have to rely on the client for information," but he stressed that the "outside counsel," Cushman, Darby, & Cushman, hired by HHS in the summer of 1986 to handle HHS defense in the PTO interference,

"... would have to see the data. I agree it was important to verify data. Cushman, Darby was supposed to do that" (op cit.).

But the Cushman, Darby attorneys told Subcommittee staff they looked at very little data; what they did examine they generally did not understand. The data submitted to PTO in support of the Gallo et al. "Preliminary Statement" is a notable example. Yet, according to Grinstead,

"To the extent I had concerns about Gallo's reliability, I was very reassured by the DOJ and Cushman, Darby work" (op cit.).

Grinstead said that, when questioned, Gallo and his people "had perfectly good explanations" for their statements and actions. Grinstead said if at any point, he had felt Dr. Gallo was lying, he (Grinstead) would have gone to the HHS General Counsel and told him, "We have a problem." But, said Grinstead, "that never happened."

Yet according to Darrel Grinstead, Dr. Gallo told him the first sample of LAV was "not useable," and the second sample, "did not help us." Grinstead said he remembered going to Dr. Gallo's laboratory on several occasions, partly for "education about the science," in which, said Grinstead, "I relied heavily on Gallo." Grinstead said that, among other things, he looked at scientific papers and other documents Gallo showed to him. Grinstead said he never attempted to trace any of these documents to putative primary data. Not surprisingly, according to Grinstead,

"Nothing came to my attention that indicated there was cause for concern" (op cit.).

In fact, there were a number of items of information that did not come to Darrel Grinstead's attention, that certainly should have done. According to Grinstead, he was not told about the Harmison/Riseberg trips to NIH and CDC, neither was he told about the Malcolm Martin memoranda. And, incredibly, according to Grinstead,

"To this day, I do not remember knowing Pasteur had a blood test" (op cit.).

(4) Dr. Lowell Harmison: By common account (except his own), the leader of the HHS effort during the early phases of the French/American dispute was Dr. Lowell Harmison. NIH and HHS officials and attorneys unanimously described Harmison as "the lynchpin" of the HHS defense, "the chief individual," "the man running the show."

During the Subcommittee's July 22, 1993 hearing, Dr. Harmison was questioned at some length concerning his role in the French/American dispute. Several themes were evident in Harmison's testimony. These themes included (1) the assertion that the provenance of the virus was irrelevant to the dispute and (2) the assertion that PTO was the proper/sole authority for dealing with the dispute.

What was most striking about Dr. Harmison's testimony, curious for one so centrally involved, were his pervasive denial of responsibility and his inability or unwillingness to describe what he did and why, relative to the dispute.

Dr. Harmison denied it was his job to investigate the claims of Gallo et al.:

"I was interested in determining the policy issues that were part of that particular issue to understand that at a policy level. I was not in there to check notebooks and laboratory notes. That is the kind of thing that was independently pulled out and provided to the Patent Office, to provide an objective, clear, independent assessment ...

"And if they couldn't substantiate the claims and the data, that was their issue, and if the infringement showed infringement, the patent would have been declared invalid. That is not a role, in my opinion, for health people such as myself... (7/22/93 Subcommittee hearing; transcript p. 34).

Dr. Harmison acknowledged he asked Dr. Fischinger to examine the claims of Gallo et al., yet he (Harmison) said he did not remember discussing the Fischinger report with Fischinger or with James Mason, the person to whom Harmison reported, who delegated the day-to-day handling of the dispute to him. Harmison said he read the Fischinger report, but when asked what it said, his answer was only this:

"I said the report is very clear, and I am not repeating verbatim what the report said. The report clearly articulated the nature of the NCI work that was the foundation for the patent" (op cit., pp. 134-136).

Asked if he personally inquired into the basis for the conclusions contained in the Fischinger report, Harmison said this:

"I think looking behind, that came from people in the various members of the institutes who came to the meetings on a regular basis and expressed opinions and positions and attitudes on these efforts. That explains -- that is the integrity of the scientific and the personnel involved in the process. You are asking me to comment on their integrity?" (op cit., p. 137).

Dr. Harmison repeatedly asserted that the PHS AIDS Executive Task Force was the body that reviewed and ruled on the adequacy/significance of key documents related to the French/American dispute, e.g., the Fischinger report and Malcolm Martin's memoranda. Concerning the Fischinger report, when asked if he provided the report to independent experts who could evaluate it, Lowell Harmison responded,

"That was not something that was a part of my responsibility ... I think the Task Force and the other members that would have gotten the report in its normal distribution was a part of looking at that result."

Dr. Harmison also said that Dr. Fischinger "presented the essence" of his report to the Task Force." But there is no evidence that any members of the Task Force ever saw the Fischinger report, much less that the Task Force discussed the document and/or the merits of Dr. Gallo's claims. The Task Force minutes contain only one cryptic reference that appears to pertain to the French/American dispute, during the Fall of 1985:

"Dr. Harmison, reporting on Science, briefed the members on issues relevant to the patent filed by the Department in connection with the test for HTLV-III antibody" (9/9/85 minutes of the PHS AIDS Task Force; p. 5).

Dr. Harmison also denied speaking to Dr. Gallo about the matters at issue in the French/American dispute, a denial starkly at odds with Gallo's own testimony (see above). Dr. Harmison invoked the bureaucracy's "chain of command" as the reason he allegedly did not speak to Dr. Gallo:

"I personally, in this matter, did not, as I recall, speak to Dr. Gallo, because this was a matter of not inserting myself between his immediate levels of supervision, and I worked with Dr. Fischinger ..." (op cit., pp. 43-44).

It bears mention that Dr. Harmison's concerns about "inserting himself" into "immediate levels of supervision" clearly did not inhibit his direct dealings with such individuals as Peter Fischinger and Malcolm Martin. Indeed, Dr. Harmison went to extraordinary lengths to keep Dr. Martin's superiors out of the Martin/Harmison exchanges. Yet, Dr. Harmison told the Subcommittee this:

"... this was something which I guarded very carefully, the importance of having the levels of supervision that were involved that we are working with the laboratory to collect information to have the dialogue. And it was not my area. I wasn't responsible for going in and talking to a given NIH researcher. This was the responsibility of the system...

"I think I am pretty astute, not jerking around and jumping over levels of management" (op cit., p. 152).

Dr. Harmison's denials of direct contacts with Dr. Gallo are belied by at least one vitally important, direct exchange of documents between the two (see below, for further discussion of this matter). When he was questioned about these documents, Dr. Harmison said he did not remember them.

Dr. Harmison's claimed lack of recall for critical events in HHS' response to the blood test dispute was particularly pronounced as regards Malcolm Martin's input. Asked if he recalled the NIH meeting and Malcolm Martin's statements about the identity of the IP and LTCB viruses, Dr. Harmison said, "I do not" (p. 104). Asked if he recalled receiving Malcolm Martin's memoranda, Harmison said, "No, I don't" (p. 104). Asked if he requested Martin to assemble articles and other materials relating to his views of the work of Gallo et al., Dr. Harmison responded, "I don't remember" (p. 105). Asked if the information in Martin's memoranda bore any significance to the IP charges against Dr. Gallo and his colleagues, Dr. Harmison responded, "In my view, very little, if any" (op cit., p. 112).

Dr. Harmison even claimed lack of recall concerning his own job, as in this exchange:

Q: Do you remember what your job was?

A: I think I was involved in the policy and the science of it.

Q: You were involved in the policy. And how were you involved in the policy?

A: I think the records that you have collected should express that.

Q: I am asking you. You are here to help us. Please tell us.

A: I have said, there were discussions with people as a normal part of the process of meetings --

Q: Who presided at these discussions?

A: I may have presided. It may have been the AIDS Executive Task Force.

Q: You may have? Do you remember whether you presided? Do you remember if somebody else presided? Do you remember if nobody presided? Do you not remember if anybody presided?

A: I don't remember.

Q: Do you remember there were discussions?

A: I think this is a very circular point. I have explained my policies and how I did things (pp. 121-123).

Concerning one key point, Dr. Harmison repeatedly asserted to the Subcommittee that the IP scientists,

"... didn't have a blood test until much, much later" (op cit., p. 129).

Yet, Dr. Harmison could not identify any basis for his clearly incorrect assertion. When Dr. Harmison was asked if he was aware of when the IP scientists and Gallo et al. actually created and began working with their respective HIV antibody blood tests, his response was this:

"I am not going -- I don't recall with respect to that date. That is to me not relevant. I don't recall, if I knew" (op cit., p. 175).

Pressed about his statement that the respective dates were not relevant, Harmison responded,

"I said I can't recall. To me it is irrelevant because I can't recall it" (op cit., p. 175).

F. The Negotiations

The IP/HHS negotiations got underway in mid-November. Within three weeks of the initiation of the talks, HHS and IP representatives were discussing the elements of a possible agreement, as embodied in a document titled "Possible Points of Agreement to Resolve Pasteur/HHS Dispute." These elements included:

• issuance of a joint statement recognizing contributions of both the IP and LTCB scientists

• licensing of Genetic Systems to market its blood test in the United States

• an agreement by the IP to drop all current and future legal proceedings.

   

1. Bad News From the HHS Attorneys:

The United States' willingness in early December 1985 to discuss terms of a possible settlement, in the face of (allegedly) a strong case may have been due to, in part, the results of an exercise set in motion on November 19, 1985, by Lowell Harmison. On this date, Harmison commissioned a review by outside legal counsel of the strength of the Gallo et al. patent, particularly the prospects for the patent in the event PTO declared an interference with the Montagnier et al. application. Three opinions were obtained, two from outside patent counsel, one from NIH patent attorney Leroy Randall. The opinions were not encouraging to HHS. The most favorable of the opinions, that of outside counsel Sheridan Neimark, was also the most superficial, uninformed opinion of the three.

Neimark, who had no prior involvement with the work of Gallo et al., made clear how rushed and limited his review had been:

"Because of the shortness of time and the necessity for me to present my answers to a series of questions by the close of the business day on November 26, 1985, it was not possible to study this matter as thoroughly as I would have liked to do."

Elsewhere in his opinion, Neimark referred to "our short study of less than one week."

Even more significant, it was evident from Neimark's opinion that he relied heavily on Dr. Gallo for information to substantiate his (Neimark's) opinion; in the opinion, Neimark referred to a "lengthy telephone conversation with Dr. Gallo."

Concerning whether the IP would be able to "copy the claims" of Gallo et al. and thus be able to provoke an interference, Neimark said this:

"These questions are very difficult to answer at present ... I am inclined to believe that Institut Pasteur cannot make the claims of the Gallo patent ... However, this does not end the matter, because it would be possible for the Patent Office to structure an interference based on claims which differ from the Gallo et al. patent claims ... The examiner could decide what the invention is, and draft one or more claims of his own which he feels would cover the invention and which could be made by both parties."

(In fact, this is exactly what happened. In April 1986, when it declared an interference between Gallo et al. and Montagnier et al., PTO defined the invention that was in dispute and then identified the claims of each party that corresponded to that invention [see below]).

Neimark said he considered it "very unlikely" the IP would prevail if an interference were declared, but should this happen, said Neimark,

"... we cannot at this point say what would be left of the Gallo et al. patent."

Neimark cited the telephone conversation with Dr. Gallo in discussing the prospects for Gallo et al. "swearing behind" the IP. Notably, Neimark identified as the "earliest date" behind which Gallo et al. would have to swear, not the September 1983 filing date of the IP blood test patent application, but the May 20, 1983 publication date of the Barre-Sinoussi et al. Science paper.

Neimark said Gallo et al. could swear behind Montagner et al.:

"... either by proving that the invention was made before that date by reducing the invention to practice (which may be difficult to do), or by showing conception of the invention coupled with due diligence from a time earlier than May 20, 1983 through April 23, 1984."

Neimark cited his conversation with Gallo:

"... he advised us that his work on this invention started in the summer of 1982 and that such work included a conception of the invention, and that there has been continuous and daily diligence six or seven days per week, every week, since that time."

Neimark said Gallo et al. would have to prove due diligence,

"only to a date prior to September 15, 1983, the earliest date to which the Institut Pasteur team would probably be entitled."

But importantly, Neimark said there were two circumstances under which IP might be able to obtain an earlier date:

"... Institut Pasteur might be able to obtain a[n] earlier date if they could prove the introduction of their invention into the United States at an earlier date; second, they would be able to attempt to prove an earlier date on the issue of derivation, i.e., that the Gallo et al. team derived their invention from the Institut Pasteur team."

Here, contrary to Lowell Harmison's claims, was a strong assertion that the identity of the virus used by Gallo et al. and the fate of the Gallo et al. blood test patent were inextricably intertwined. But Neimark asserted the burden of proof on Pasteur in proving derivation would be "very great." Without substantiation, Neimark said this:

"... the evidence seems strong that Dr. Gallo's team did not put the sample or samples received from France to any use relative to the invention."

Lowell Harmison, of course, knew better; he knew well that at least one respected NIH scientist, Malcolm Martin, could offer proof that derivation did occur -- that the LTCB scientists did "put the samples received from France to use relative to the invention." Thus, even the most favorable of the legal opinions provided to HHS in November 1985 must have been deeply disquieting to Lowell Harmison and others who had been made privy to the data from Malcolm Martin's laboratory, not to mention the data from Gallo's own lab!

The other two legal opinions supplied to Lowell Harmison were rendered by attorneys with more knowledge of the work of Gallo et al. John Roberts, who rendered one of the opinions, was the senior partner in the law firm that prepared both the LTCB blood test and cell line patent applications, plus numerous subsequent LTCB applications. Roberts' opined that,

"... the broadest definition in the claims of the [IP] British application could overlap the U.S. claims."

However, according to Roberts, the IP claims,

"may contain an inherent flaw which makes them unpatentable (and therefore not capable of being used in interference proceedings) ..."

i.e., the IP patent application did not indicate,

"... the need for or inclusion of an immortalized cell line."

Roberts was wrong in his judgment of a possible "inherent flaw" in the IP blood test patent application. Within a few weeks of the preparation of Roberts' opinion, PTO would rule in the Montagnier et al. application that a permanent cell line was not necessary for the HIV antibody blood test.

Another of Roberts' determinations, one that was largely correct, was that the IP,

"... British application supports copying U.S. claims 1, 5, 6, 7, 8, and 9 ... U.S. claims 2-4 and 10 have no basis in the British disclosure ... and therefore should not be subject to interference proceedings."

In fact, when PTO finally declared an interference between Gallo et al. and Montagnier et al., all but one of the Gallo et al. claims was included. But Roberts' determination that six of the ten Gallo et al. claims were subject to an interference would itself have been a daunting prospect for HHS, since the IP application predated the Gallo application by several months and the feasibility of Gallo et al. "swearing behind" Montagnier et al. was in considerable doubt.

The third legal opinion provided to Lowell Harmison came from the head of the NIH Patent Office, attorney Leroy Randall. Randall's opinion debunked a favorite HHS argument against the IP blood test, i.e., that it was (allegedly) not commercially viable and thus, was not patentable. Roberts made clear that arguments about the commercial utility of the IP blood test were unlikely to be successful in derailing the IP application. Said Randall,

"... the holdings have generally been that research purposes are sufficient for patent ..."

Concerning whether or not the IP would be able to copy the claims of Gallo et al., Randall offered a potentially devastating scenario:

"It would appear difficult for Pasteur to copy our claims to the envelope (p41) protein, and the test based thereon. However, Pasteur does appear to be able to copy our claims directed to 'HTLV-III or fractions thereof' ... It would therefore appear that our claims directed to the envelope protein (p41) would remain ours, following any interference" (emphasis added).

The latter half of this passage is interesting, focusing as it does on what would "remain ours," following an interference at PTO. The obverse, of course, was what would not "remain ours," i.e., what HHS might lose following an interference. In this regard, what Leroy Randall apparently concluded, in late-November 1985, was that although Gallo et al. might retain their claim to a blood test based on the envelope protein (claim 3 of the 10 Gallo et al. claims), they would not retain their other blood test claims. That Randall rendered this opinion in the Fall of 1985 is extraordinary, given that the U.S. Government later would argue that Pasteur's blood test was inherently defective and Gallo et al. were entitled to the entire patent, because the LTCB blood test relied on the envelope protein.

Randall's opinion concerning the IP scientists' priority vis-a-vis the majority of the blood test claims was clearly prophetic. Not only was the IP named "Senior Party" in the PTO interference, which encompassed all but one of the Gallo et al. claims, by the Summer of 1986, the Gallo et al. claims in a number of blood test "CIP" patent applications were repeatedly rejected by PTO, on grounds that they were anticipated by the prior art of Montagnier et al. (see below).

2. IP's Quest for Information:

At the same time that HHS was weighing the legal prospects for Gallo et al., the IP attorneys were making efforts to obtain information about the LTCB scientists' use of LAV. IP attorneys at the law firm of Townley & Updyke prepared a massive FOIA request to be filed at HHS and the Department of Commerce, but IP's Weil, Gotshal attorneys sought to obtain the documents relating to use of LAV via a more informal route. In meetings with Mac Haddow, the Weil, Gotshal attorneys agreed to provide HHS a copy of the IP's United States patent application. In return, according to a November 26, 1985 Riseberg-to-Fischinger memorandum:

"... Mr. Haddow agreed to supply Pasteur's lawyers, by November 29, with copies of existing materials documenting what happened to the two shipments of LAV provided to NCI by Pasteur in 1983."

The contents of the documents provided to the IP attorneys purportedly "documenting what happened to the two shipments of LAV" are revealing; they show vividly how vitally important information was deliberately withheld from the IP.

Riseberg's memorandum to Fischinger indicated Fischinger had told him "certain key individuals" would be "away from Bethesda through at least November 29," for this reason, Fischinger agreed to,

"... provide Grinstead with a partial package by November 27, with the remainder to be collected as soon as possible."

In reality, it appears only one delivery to the IP attorneys was made. This delivery comprised two memoranda -- one written by Dr. Gallo to Lowell Harmison, one written by Dr. Popovic to Dr. Gallo -- together with eight pages of laboratory notes purportedly representing the LTCB's experiments with LAV, none of them provided to Peter Fischinger for his "investigation."

Both the Gallo and Popovic memoranda were dated November 26, 1985, the same date as the Riseberg-to-Fischinger memorandum. Both memoranda mention the short notice given for submission of the LAV records. Dr. Gallo's memorandum to Lowell Harmison made clear Gallo understood well the nature of the request:

"Attached is the information which has been requested on experiments performed with the supernatant samples of 'LAV' sent to this laboratory. This information was prepared quickly since we had less than 48 hours notice that it was needed."

The remainder of the Gallo-to-Harmison memorandum comprised a lengthy complaint about what Gallo apparently perceived as the inequities of the blood test dispute, in which, according to Gallo, he was "constantly subject to responding to their accusations..."

Dr. Popovic's memorandum to Dr. Gallo was more substantive, containing a number of important elements, several of which were demonstrably incorrect or incomplete. Also significantly incomplete was the scanty collection of data pages appended to Dr. Popovic's memorandum. The data pages appended to Dr. Popovic's memorandum consisted almost entirely of protocol pages (i.e., pages describing methods, rather than results of the LAV experiments) or pages reporting exclusively negative experimental results. The one data page that reported positive results for an LTCB LAV experiment -- the vitally important October 6 IFA experiment that produced positive results against BRU serum for a cord blood culture of July LAV -- had been photocopied in such a way that the results were entirely illegible. In fact, it is impossible even to discern from the page that it includes results from an experiment using LAV.

Even more significant is what was not appended to Dr. Popovic's memorandum. Among the LAV data pages not appended to the memorandum, and thus not provided to Lowell Harmison, Mac Haddow, or the IP attorneys were the following:

• the September 20, 1983 data pages from the notebook of Dr. Prem Sarin, reporting positive RT results for one of the two cord blood cultures infected with July LAV;

• the October 3, 1983 letter from Matthew Gonda to Mikulas Popovic reporting the LTCB's first identification of the suspected AIDS virus as a "lentivirus";

• the October 21, 1983 notebook pages of Elizabeth Read-Connole showing the infections of five T-cell lines with LAV;

• the several pages dated between October 21, 1983 and January 13, 1984 showing the repeated positive results with the two successful LAI/LAV permanent cell lines, HUT-78/LAV and Ti 7.4/LAV. Particularly noteworthy among the omitted pages are the December 14, 1984 letter from Matthew Gonda to Dr. Popovic, reporting "productive lentivirus infection" of the two LAI/LAV cell lines and the December 14, 1983 IFA data from Read-Connole showing positive results for the same two cell lines, when tested against BRU serum.

   

Also noteworthy among the data pages not appended to Dr. Popovic's memorandum were the November 9, 1983 RT results from Dr. Prem Sarin, showing that three of the five LAI/LAV T-cell lines were RT positive. Dr. Sarin's RT data were never provided to the IP attorneys.

-- the January 13, 1984 freezer log indicating that freezes of both the LAI/LAV cell lines existed on this date (this log was never provided to the IP attorneys);

As for Dr. Popovic's November 26 memorandum, it is a curious blend of clearly incorrect and partially correct statements. The very subject of the memorandum is provocative -- "Review of Memo of August 19, 1985, to Dr. Howard Streicher" -- suggesting someone had questioned the accuracy of Popovic's earlier memorandum. Although it purportedly was a "review" of the earlier memorandum, the November 26 memorandum perpetuated and expanded on several of the falsehoods in the earlier memorandum, asserting, for example, that Popovic's July LAV experiments had been entirely unsuccessful. Thus, in the November memorandum, Dr. Popovic said, concerning July LAV, that:

"Using this sample, we did not succeed in transmitting the virus into cells. We conducted these experiments twice with consistently (sic.) negative results."

Concerning September LAV, in the November 26 memorandum Dr. Popovic provided vital new information, never-before-revealed (so far as is known), to HHS officials. Yet, Dr. Popovic stopped well short of the whole truth. Concerning September LAV, Dr. Popovic said this:

"In this case, we did succeed to transmit the virus in cord blood T-cells assayed on October 6th and 18th, 1983 ..." (note: Popovic and Gallo later would tell OSI the October 6 experiments were performed with July LAV; in the 1991 Guo et al. letter to Nature, Gallo and his associates said that the September LAV samples were not used for LTCB experiments before "late October" 1983).

Yet, Dr. Popovic did make some significant, albeit imperfect revelations:

"We successfully transmitted LAV into permanent cell lines in December 1983. The positive immunofluoresence was scored on December 14, 1983, in Ti7.4 ... This cell line was used for comparative studies with H9/HTLV-IIIb (protocols will be provided at a later date from Drs. George Shaw and Beatrice Hahn). Attempts to transmit LAV ... to H9 cells and other clones of HT cell line on February 13, 1984, gave negative results ..."

There are several significant points to be made about these statements by Dr. Popovic:

• The mere admission of the successful transmission of LAV to permanent cell lines is significant, but Dr. Popovic's dating of this event to December 1983 is fully two months later than it actually occurred.

• Dr. Popovic specifically indicated that LAV was transmitted to more than one permanent cell line ("We successfully transmitted LAV into permanent cell lines in December 1983"), yet Popovic described the experiments with only one line, Ti7.4. An obvious question was what other cell lines were used to grow LAV, and with what results. But there is no indication Lowell Harmison or anyone else at HHS pursued these important questions.

• Dr. Popovic's revelation that Ti7.4/LAV was compared with HTLV-IIIb is a very significant one. The fact that, according to Popovic's memorandum, the comparison experiments were performed by Drs. Shaw and Hahn confirms that the comparisons were molecular/genetic. Almost certainly, the experiments described by Popovic in his memorandum are the experiments that (as described above) were performed in the late Spring/early Summer of 1984, showing that the IP and LTCB viruses were identical. But Dr. Popovic provided no information about the outcome of the LAV/IIIb comparisons, referring merely to "protocols" yet to be provided by Shaw and Hahn. No "protocols" showing the use of September LAV for molecular comparisons were provided to the IP. Consequently, the IP was left in the dark about what kinds of genetic comparison experiments were performed with September LAV, at what time, and with what results.

• Dr. Popovic invoked the putative February 13, 1984 "host range" experiment to substantiate his claim that LAI/LAV could not be grown in H9 and other clonal cell lines derived from "HT." As previously discussed (see above), this experiment is highly suspect, on many grounds.

   

Deficient as it was, the November 26 package of data was transmitted to the Weil, Gotshal attorneys on December 6. The transmittal letter, from Darrel Grinstead to attorney Nancy Buc, described the enclosures as:

"... documents responding to your request for laboratory notes and other information relating to use of the LAV samples provided to the Department by Dr. Luc Montagnier to scientists at the National Cancer Institute in 1983."

Grinstead's letter specifically noted that:

"Because some of the scientists who may have worked with the samples are not immediately available, I cannot assure that these are all of the extant documents that respond to your request. However, as soon as the remaining scientists who worked with these samples are available and can search their records we will provide you the remaining documents, if any."

But no additional documents were provided, and with the initiation of the IP's civil suit for breach of contract, the matter moved to a new arena.