X. The Settlement (And Thereafter)

In the Fall of 1986, the momentum for a negotiated settlement of the French/American dispute accelerated. At the same time, charges and countercharges continued at PTO and in the U.S. Claims Court. One individual who played a unique role in the discussions leading to the settlement was Dr. Robert Windom, the then-recently-appointed Assistant Secretary of Health.

Dr. Windom told Subcommittee staff that President Ronald Reagan personally ordered U.S. officials to seek a settlement of the dispute. To this end, IP and HHS representatives exchanged visits in the Fall of 1986. Shortly after these visits, the settlement discussions became more deliberate, with more senior attorneys on both sides taking more leading roles.

Dr. Windom's perspective on the French/American dispute, as described to Subcommittee staff, is revealing; it shows how senior officials operated with only a modicum of the "facts," selected misrepresentations fed to them by others who clearly knew better. In this regard, Dr. Windom told Subcommittee staff his principal sources of information were Drs. Harmison and Fischinger, with lesser roles for Drs. Wyngaarden and DeVita.

Dr. Windom singled out Dr. Harmison as "very helpful," one who "knew the science very well." Dr. Windom also said he personally knew very little about the charges being litigated before PTO and the Claims Court:

"I really did not know what was being alleged ... I probably was not given the fundamentals" (Subcommittee staff interview; 10/30/92).

Confirming he was "not given the fundamentals," Dr. Windom told Subcommittee staff he was never told the IP had developed an HIV antibody blood test before Dr. Gallo did so. Subsequently, while conditionally acknowledging the prior existence of an IP blood test, Dr. Windom said, "... but we marketed it first." Because of these considerations, Dr. Windom said, he thought the French were getting better than they deserved" in the 1987 settlement. When challenged as to why -- in light of the alleged superiority of the U.S. case -- the United States had any interest in negotiating a settlement, Dr. Windom responded with this:

"There were some uncertainties -- some points could be interpreted -- it was gray, not black and white."

A. Terms of the Settlement

When it was finally consummated, in March 1987, the French/American settlement embodied agreements concerning the blood test patents, the pending litigation, patent royalties, and scientific events. Drs. Montagnier and Gallo agreed to call themselves "co-discoverers" of the AIDS virus. They collaborated in a jointly-authored "Chronology of AIDS Research" that supposedly reflected the most significant contributions of the IP and LTCB scientists. The chronology was introduced with this disingenuous claim:

"... from the beginning there has been a spirit of scientific cooperation and a free exchange of ideas, biological materials and personnel between Dr. Gallo's and Dr. Montagnier's laboratories. This spirit has never ceased despite the legal problems and will be the basis of a renewed mutual cooperation in the future" (Nature, 326, 1987, p. 435).

Dr. Gallo was adamant concerning the necessity for an agreed-upon scientific chronology as part of the settlement agreement, apparently believing he could claim by fiat what he could not substantiate by data. Numerous memoranda and related documents show that Dr. Gallo insisted there could be no settlement without a scientific history, one that supposedly would be the definitive account for all time. Dr. Gallo repeatedly cited the 1987 chronology (and a similar, narrative chronology coauthored by Montagnier and Gallo in Scientific American in 1988) to OSI as the authoritative accounts of his work. These chronologies, which contained a substantial number of suspect claims concerning the work of the LTCB scientists, obviously, did not end the scientific controversy.

As for the blood test patents, working in conjunction with PTO, the two sides agreed that both the LTCB and IP patents would remain in place (the IP patent issued in late 1987). The names of each side's scientists were added to the other side's patent, under the fiction that an inadvertent error was made in listing the inventors, when the patent applications were filed.

The two sides also agreed to donate the bulk of the royalties from their blood tests to a foundation established as part of the agreement. Only one-quarter of the combined donated royalties were committed for AIDS research; HHS and IP received the remaining three-quarters, with no strings attached, in equal shares. This arrangement was altered, in July 1994, to provide a larger royalties share to the Institut Pasteur, ostensibly because HHS belatedly realized that since the 1987 settlement, the IP had not received an equitable share. Dr. Gallo's use of the IP virus for the LTCB blood test was given only passing mention by HHS.

B. Unraveling of the Settlement:

Even as the terms of the French/American settlement were hammered out, the underpinnings of the settlement were being eroded. Investigative journalists continued to pursue the questionable claims of Gallo et al. One article, Steve Connor's February 1987 article in New Scientist -- "AIDS: Science Stands on Trial" -- actually threatened to derail the settlement negotiations. Shortly thereafter, also in 1987, the first edition of Randy Shilts' memorable And the Band Played On was published. Other books and articles followed, both in the United States and abroad, culminating in the November 1989 expose in the Chicago Tribune by journalist John Crewdson.

Meanwhile, research was underway that itself had significant potential to demolish the settlement's underpinnings. The results of this research were described in a remarkable exchange of correspondence between Dr. Gerald Myers, a leading HIV geneticist, and several NIH scientists and senior scientific administrators, including Dr. Gallo and Drs. Anthony Fauci, Director of the NIH National Institute of Allergy and Infectious Diseases (NIAID) and Director of the NIH Office of AIDS Research, and Dr. Samuel Broder, Director, NCI..

Dr. Myers was and is Director of the Los Alamos HIV Sequence Data Base and Principal Investigator of a contract funded by NIAID. The existence of the "Myers documents" was made known to the Subcommittee by a source outside of NIH, in late 1993. Despite numerous document requests to NIH, the Myers documents were not previously provided to the Subcommittee. Not only were the documents withheld from the Subcommittee, their existence was not disclosed to OSI, to ORI, nor to the HHS/OIG. The documents, directly relevant to the investigations of all these entities, bore on the still-unresolved central issue of the entire case, i.e., the possible misappropriation of the Institut Pasteur (IP) virus, LAV. The significance of the information contained in the Myers documents, as well as details of events instigated by the documents, are described in the following.

Just one week after the settlement agreement was signed, Dr. Myers wrote to a number of HIV scientists, principally at NIAID, including officials close to NIAID Director Anthony Fauci. Dr. Myers described results of some of his recent analyses of the IP and LTCB prototype viruses as follows:

"Literally a 'double fraud' took place when the H9 cell-derived isolates [clones] -- HXB2, BH10, BH8, BH5, HXB3, PV22 ... were declared to be i) independent from LAV (BRU) and ii) derived from blood pooled from several patients. The probability of either account being true is very small by this analysis, and I predict that it will become smaller with each U.S. isolate sequenced in the future ...

... it is the astonishing and unforeseen variation of the virus which exposes the fraud ... I suggest that we have paid for this deception in more than the usual ways. Scientific fraudulence always costs humanity ... but here we have been additionally misdirected with regard to the extent of variation of the virus, which we can ill afford during the dog days of an epidemic let alone during halcyon times." (4/8/87 Myers-to-LaMontagne et al. letter; p. 4).

Dr. Myers' April 1987 letter was closely held in the succeeding years. The potential of its information for demolishing the premises of the settlement agreement was evident. Dr. Myers later made clear the difficulties he encountered in trying to avoid the patent dispute. Writing in April 1989 to Dr. Fauci, Dr. Myers said he had encountered two problems "unavoidably entangled with the dispute about the discovery of HIV." Dr. Myers said his analyses,

"... immediately drew attention to the close similarity of the IIIb and LAV sequences,"

and that his "tree" analyses,

"... were generated at precisely the time ... the U.S. and French were settling the legal disputes that had arisen."

Dr. Myers told Dr. Fauci that he (Myers) and his Data Base colleagues,

"... agreed that the database would steer absolutely clear of the issue but that we would not suppress scientific data" (4/12/89 Myers-to-Fauci memorandum; p. 1).

But Dr. Myers' scientific/ethical concerns remained. In his April 1989 memorandum to Dr. Fauci, Dr. Myers said this:

"... I remained deeply disturbed about the claim made for the IIIb viruses -- that they derived from pooled blood of several patients. It was very difficult in 1987 to convince many researchers that the AIDS viruses mutated inordinately rapidly. The IIIb interpretation gave the false impression that the virus was more stable than other signs were indicating" (4/12/89 Myers to Fauci memorandum; p. 2).

Dr. Myers told Subcommittee staff he had hoped and believed the issues raised by his data would be resolved "within the tradition" of the scientific process. Despite his best efforts, this did not occur.

By the Fall of 1988, Dr. Myers' data had not only confirmed that LAV and IIIb were genetically identical, but that IIIb was derived from LAV, and not the reverse. Dr. Myers believed it was his ethical and scientific obligation to share this information with Dr. Gallo. Accordingly, in September 1988, Dr. Myers wrote to Dr. Gallo, summarizing for him the results of the most recent HIV Sequence Data Base analyses and telling him the following:

"From our earliest tree analyses, it was patently evident that the LAV and IIIb viruses had to have had a recent common ancestor .... By including all of the available gene sequences in a single analysis for the IIIBs, it is actually possible to define the branching order of the variants to a high degree of statistical precision. There is no doubt but that it shows the LAV source of the IIIB viruses: the NL43 clone of the BRU isolate is the oldest sequence; the published BRU follows it; the IIIBs follow thereafter...." (emphasis added; 9/20/88 Myers-to-Gallo memorandum; p. 1).

By the spring of 1989, Dr. Myers and his Data Base colleagues had accumulated important new data showing LAV and IIIb were situated squarely in the middle of the "sibling" cluster of sequences, all pairs of which, with the alleged exception of LAV and IIIb, were known to be derived from the same person. According to Dr. Myers, Dr. Gallo at this time, at the urging of his closest colleagues, including Drs. Mikulas Popovic and Flossie Wong-Staal (herself an editor of the HIV Sequence Data Base), was prepared to "throw in the towel" and admit that IIIb originated with LAV. Dr. Gallo prepared an ambiguously worded, but still compelling statement that was to be published in the April 1989 issue of the Data Base. The statement read, in pertinent part:

"Can we conclude ... that HTLV-IIIb and LAV BRU did indeed originate from the same individual? If that is indeed the case, it would only have resulted from a mix-up in my laboratory when the LAV from Luc Montagnier was temporarily growing along side the other isolates we had obtained. We certainly cannot rule this out, particularly since we and, I am told, many other investigators have often experienced the phenomenon of laboratory contamination of HIVs ....

"I do ... think that it is necessary as a result of the data compiled in this book to acknowledge the distinct possibility that HTLV-IIIb and LAV BRU are the same isolate" (4/17/89 Gallo draft statement).

Dr. Gallo's statement was never published in the HIV Sequence Data Base. According to Dr. Myers, on the eve of its publication, the statement was precipitously withdrawn by Dr. Gallo who told Dr. Myers he had "discussed the matter with the lawyers" and they advised him not to publish the statement (the "lawyers" were not identified to Dr. Myers, and there is no confirmation that any such advice actually was given).

According to Dr. Myers, Dr. Samuel Broder also objected to the publication of the Gallo statement in the Data Base, on grounds that the Data Base "is not peer reviewed." In fact, the findings published in the Data Base are peer reviewed by an exceptional group of editors, including at the time Drs. Howard Temin, Walter Fitch, and James Mullins.

Dr. Myers said Dr. Broder telephoned him and in addition to voicing his concerns about peer review, raised questions about the strength of Dr. Myers' data. Dr. Broder reportedly asked Dr. Myers to "write down some of my thoughts." Dr. Myers responded in an April 24, 1989 memorandum. Dr. Myers sent Dr. Broder a copy of the April 1989 Myers-to-Fauci memorandum, cited above. Myers told Broder that although he and his colleagues had earlier remained silent,

"... new questions are rapidly emerging in relation to viral sequences that just happen to be in the territory of the 1987 dispute. Bob Gallo's problem is whether to go ahead and speak out now, when he can take some initiative or to wait until he could be placed into a more passive and reactive position" (4/24/89 Myers-to-Broder; p. 1).

Myers further said, "Is there any evidence on Gallo's side? Not really" (op cit., p. 1).

The Myers/Broder discussions took place after Dr. Gallo backed out of the commitment to publish the previously described acknowledgement. According to Dr. Myers, a fall-back plan was then developed, according to which Dr. Gallo was to make the admission that IIIb originated with LAV "on a natural occasion," i.e., in the text of a scientific paper on a broader subject. Dr. Gallo failed to keep this commitment, and the promised paper containing Dr. Gallo's admission was not published. Dr. Myers said he was never given any explanation for the failure to publish the paper.

Dr. Myers' findings and conclusions must be considered in context of Dr. Gallo's previous actions as well as his (Gallo's) failure to disclose Dr. Myers' findings to OSI. As previously described, as early as the summer of 1984, Dr. Gallo knew, based on data from his own laboratory, that LAI/LAV and LAI/IIIb were genetically identical. After failing in the effort to convince Dr. Montagnier to admit responsibility for contaminating LAV with "IIIb," Dr. Gallo changed tactics and began to claim, in numerous scientific fora, that LAV and IIIb actually were genetically distinct. Dr. Gallo further maintained, adamantly, that LAV could not have "contaminated" his cell lines because "it was physically impossible to grow LAV."

Another part of the story propounded by Dr. Gallo and his closest associate, Dr. Flossie Wong-Staal, was that the several clones of IIIb, obviously very similar in genetic make-up, were derived from multiple independent samples allegedly used for the "pool" experiment. By extrapolation, using this argument, Dr. Gallo attempted, among other things, to make the case that the striking similarity of LAV and IIIb did not obviate the possibility that they actually were independent isolates.

The rapid mutation and resulting heterogeneity of the AIDS virus are now widely recognized as posing significant obstacles to the development of effective strategies for prevention and treatment of AIDS. Dr. Myers' concerns about the delay in scientists' recognition of HIV heterogeneity -- a delay caused in part by what Dr. Myers termed the "double fraud" associated with Dr. Gallo's account of the origins of "his" virus -- are a poignant reminder of the damage that resulted from the "fraud."

It also must be noted that Dr. Gallo's testimony to OSI concerning these matters was substantially less than forthcoming. Despite having agreed, just one year earlier, on the need for a public acknowledgement that IIIb and LAV were genetically identical, and an acknowledgement that IIIb was derived from LAV and not the reverse, Dr. Gallo in 1990 made numerous misleading statements to OSI of which the following are only a few examples:

"With time and more sequences available the relative similarities of this pair (LAV and IIIb) remains unusual but not unique" (4/8/90 "Opening Scientific Statement" to OSI; p. 5).

"... I would conclude that there can't be a conclusion today ... I don't think we can make any conclusive statement .... Also, please keep in mind that though I said if this possibility or probability exists ... I didn't tell you where it [contamination] happened with certainty also. I believe that question is open, no matter what information you may have, and I believe that question [where the contamination took place] could be solved in the immediate future" (4/11/90 Gallo OSI interview; transcript p. 72).

Elaborating on the "Paris contamination" theory, thoroughly discredited by Dr. Myers' data, Dr. Gallo's attorney asserted this to OSI:

"... IIIb was sent to Paris in May of 1984. It could be that what they then tested ... was a contaminant. It's at least possible."

Dr. Gallo then added:

"The other direction" (4/11/90 interview; transcript p. 75).

Dr. Gallo also, once again, made explicit the linkage between his "other isolates" claims and the LAV/IIIb identity:

"I have felt it's an irrelevant question, for the most part ... scientifically, ethically, medically and historically, because there are so many other isolates and if anybody had half as many in tissue culture within the next year I would be surprised, so I've never felt it to be an important question. It's only in this context of the questioning that I'm getting here that it becomes important or for politics that have been played in newspapers ..." (4/11/90 interview; transcript p. 71).

Yet, less than a week before he made these statements to OSI, Dr. Gallo wrote a letter to Dr. Myers, in which Dr. Gallo said:

"I have wanted to tell you for some time -- that you were certainly right, and I should have listened to you ... as early as 1984 I told her [a reporter for the journal Science] IIIB could be a contaminant of LAV. Because of everything else we did and because of other isolates and because of the help I gave Montagnier early on, I just could not believe anyone would really care" (4/5/90 Gallo-to-Myers letter).

Dr. Gallo described his allegedly nonchalant attitude toward the genetic identity of the IP and LTCB viruses in more vivid terms to OSI:

"I'm interested in a vaccine and in curing the disease. I'm interested in basic science and how the virus works. Do you think I'm going to get back there in the mud of whether IIIb and LAV came from this lab or the other lab when I have all kinds of other isolates and things are moving like a bullet? And I want to be worried about that, and did it happen in my lab, or their lab ... I mean, who bloody cared?" (4/11/90 OSI interview; transcript p. 82.

Dr. Gallo's characteristic utterances speak volumes, and are an apt note on which to end this staff report.