A. Practices at the LTCB
Immediately upon publication of the May 1984 Science papers, the LTCB received numerous requests for its IIIb-infected cell line, its "H9" uninfected cell line, and related reagents. According to commonly-accepted standards for scientific collaboration and exchange, these materials should have been readily and unconditionally provided to qualified scientists, since they had already been published. From a public health standpoint, one could even argue that the materials should have been unconditionally shared well before their May 1984 publication, considering the devastation of the AIDS epidemic and the potential benefits the materials had for AIDS/HIV research.
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Dr. Gallo required every scientist who received his cell lines and reagents to sign a restrictive transfer agreement, which besides routine safety and noncommercialization provisions, included a requirement that,
"Work performed will be on a collaborative basis with Dr. Gallo and his laboratory unless stated otherwise."
Dr. Gallo has claimed that the collaboration requirement included in the LTCB transfer agreement was a mere "formality," and that he never actually mandated that research performed by recipients of LTCB materials be collaborative with LTCB scientists. But the facts show otherwise. For Dr. Gallo's close colleagues, the collaboration provision of the transfer agreement was modified to make it less restrictive, as happened for Dr. Robin Weiss, on whose transfer agreement Dr. Gallo added handwritten notes modifying the requirement that "work performed will be on a collaborative basis," to this:
"Collaboration at will for Dr. Weiss O.K. R. Gallo."
For other scientists -- those deemed by Gallo et al. to be potential or actual competitors, the collaboration provision, as well as other provisions of the LTCB transfer agreement, were modified to make them even more restrictive (see below).
Contrary to Dr. Gallo's claims to OSI, to NIH Director Bernadine Healy, and others, the transfer agreement was not imposed on Gallo by NCI/HHS officials, contrary to his wishes. In March 1992, in an attempt to defend himself against possible disciplinary action for his withholding and restricting use of LTCB materials, Dr. Gallo wrote this to Dr. Healy:
"The restrictions on distribution of HTLV-IIIb were made at the request of NIH and HHS administrators, Drs. Fischinger and Harmison ... the more restrictive non-disclosure form was actually Dr. DeVita's form, not mine."
But according to NCI Associate Director Dr. Peter Fischinger (10/23/85 Fischinger-to-Blout letter) the transfer agreement mandating collaboration was "spontaneously drafted" by the Gallo laboratory. As for the "more restrictive, non-disclosure form," it was not Dr. DeVita's form. Dr. Gallo personally was party to the decision by which an extraordinary "confidentiality/secrecy" provision was added to the agreement. In fact, when Dr. Gallo was asked directly by OSI, "Someone made you use that form?" his response was this:
"No, it was just what they prepared. They didn't make me. They said you got to use this ... Well, I didn't pay too much attention to it ...
"It either came from Peter Fischinger or Harmison. I don't know who else it could be from. I really don't know. But, anyway that is what we were advised to do" (9/23/90 OSI interview; transcript pp. 64-65).
Dr. Gallo failed to even respond to a written request for the HIV-specific rabbit antiserum, from Dr. Jay Levy (notes in Gallo's hand show he pondered with his staff how to respond to the request; yet well before publication of the May 1984 Science papers, Dr. Gallo had provided the antiserum to his close colleague, Dr. Daniel Zagury);
Other unique reagents also were withheld from qualified scientists, while favored scientists were given ready access. On April 25, 1984, Dr. James K. McDougall, of the Fred Hutchinson Cancer Research Center in Seattle wrote to Dr. Gallo requesting "an HTLV probe" to assay what McDougall described as "a large number of DNA samples" from lymphadenopathy and AIDS patients. Gallo responded on May 10, telling McDougall, that, with respect to an HTLV-III probe,
"... we are still in the middle of characterizing some clones. It will be awhile before we can distribute them."
Gallo added, in a handwritten "P.S." at the bottom of the letter, "Jim, write to me again in about 6 weeks. Bob."
Apparently taking Dr. Gallo at his word, Dr. McDougall wrote again on July 3, 1984, saying,
"If the HTLV-III clones are now available for distribution, we would be delighted to receive them."
A one-word note, in Dr. Gallo's hand, appears at the top of McDougall's letter -- "No."
In contrast, another scientist, a close Gallo colleague who requested the probes on May 31, 1984, received a reply from Gallo that said this:
"We will definitely make the molecular clones available to you as soon as they are published. Please remind me then" (Gallo-to-Alfred Prince [undated]).
At the same time as he freely provided the uninfected H9 cell line to such close colleagues as Drs. Robin Weiss, Daniel Zagury, Dani Bolognesi, Wade Parks, Myron Essex, and Barton Haynes, Dr. Gallo significantly delayed providing the line to other scientists. The most noteworthy instance of this conduct was Dr. Gallo's delay in providing H9 to the IP scientists, who made repeated requests for the cell line so they could complete the LAV/IIIb collaborative comparison studies agreed to by Gallo. Dr. Gallo agreed in mid-May 1984 to provide H9 to the IP scientists, but Montagnier and his colleagues did not receive the line until September/October 1984.
Dr. Gallo claimed to Dr. Chermann that "... the U.S. Government position is to hold this line" until it was fully characterized. And despite his previous commitment to provide the H9 line to the IP scientists, Dr. Gallo insisted the line was not necessary to complete the virus comparisons:
"... good God, how does the uninfected cell line affect comparison between LAV and HTLV-III[b] ... Don't use this argument to get the uninfected HT cells. We will send them to Pasteur Institute soon, but when I think it is scientifically and administratively appropriate" (August 24, 1984 Gallo-to-Chermann letter).
(As previously discussed, see above, Dr. Gallo claimed the IP virus did not grow in H9 at the LTCB. Dr. Gallo's desire to prevent other scientists from disproving this claim almost certainly accounts for Gallo's reluctance to provide H9 to the IP scientists. When the IP scientists did, finally, receive H9, they were readily able to grow their virus in the line.)
Dr. Gallo refused outright to provide the uninfected H9 cell line to, among others, Drs. Michael Gottleib, Carel Mulder, Frederick Jensen and Malcolm Martin, of the NIH's National Institute for Allergy and Infectious Diseases (NIAID).
Concerning the uninfected cell line, Dr. Gallo told Dr. Martin and others he would not provide the uninfected line to them because it was "still being characterized" for a planned "detailed publication." No such publication ever appeared. Dr. Gallo also demanded to know what Dr. Martin planned to do with the H9 line, if he did obtain it, and -- clearly trying to head off the possibility of LAV/IIIb comparisons -- Gallo told Martin this:
"... I do not think it would be appropriate for you to put the French isolate in them [H9 cells]. That is for them [the IP scientists] to do in collaboration with me and my co-workers and is ongoing" (6/22/84 Gallo-to-Martin letter).
Dr. Gallo's claims about an ongoing collaboration with the IP scientists was, clearly, a sham. Even as Dr. Gallo wrote to Dr. Martin that the IP scientists would be growing their virus in H9, in collaboration with the LTCB, Gallo was refusing to send H9 to Dr. Montagnier and his colleagues, and -- as described above -- mocking their requests for the line.
In 1990, when he was challenged by OSI/ ORI about his withholding and restricting use of the uninfected cell line, as well as other LTCB materials, Dr. Gallo (and his associates) commenced a chorus of claims about the numbers of scientists who had received the cell line. Dr. Gallo's associates went so far as to launch a world-wide fax survey (at U.S. Government expense) of LTCB materials' recipients, in an attempt to substantiate Dr. Gallo's claimed generosity. The results of the survey -- for all the cost and time involved -- were largely irrelevant, since they frequently referred to reagents other than the H9 cell line, and covered periods of time considerably later than the period in which the withholding/restrictions took place.
In 1993, confronted with irrefutable evidence that he withheld H9 from some scientists, Dr. Gallo acknowledged the withholding, for what he claimed was a limited period of time in the Summer of 1984, claiming the line was withheld due to his concerns that it was contaminated with "IIIb" or some other AIDS virus isolate. Dr. Gallo told Subcommittee staff he withheld the line from Dr. Malcolm Martin and other scientists he felt he "could not trust," who would "stab me in the back," who "would embarrass me or call me dishonest if there was something wrong with the cells" (July 22, 1993 staff interview).
But these claims by Dr. Gallo were highly suspect. First, according to the May 1984 Popovic et al. Science paper, the parental "HT" -- actually HUT-78 -- cell line, was,
"... tested for HTLV before being infected in vitro and was negative by all criteria including lack of proviral sequences" (Popovic et al., 224, p. 498).
Further, according to both Gallo and Popovic, H9 and the other clones were derived from HUT-78 -- in part -- precisely in order to ensure that no adventitious agent was present.
More significantly, Dr. Gallo's claims that he withheld the H9 line in the Summer of 1984 because he feared it was HIV-contaminated are contradicted by documentary evidence and his own claims in other fora, i.e., the claim to NIH Director Dr. Bernadine Healy that,
"From about the time of publication of the papers [the four LTCB Science papers] in May 1984 to August of 1984, I had made uninfected H9 available to approximately 45 investigators" (3/20/92 Gallo-to-Healy letter; p. 2).
Dr. Gallo's claim that he provided the H9 line to 45 scientists by August 1984 is almost certainly an exaggeration. But documentary evidence shows that he did indeed provide it to several scientists during this period, with no warning that a possible contaminating virus might be present, a circumstance which, if true, could have devastated the recipient scientists' experiments. Yet at the same time, as noted previously, other scientists' requests were denied or simply ignored. Dr. Gallo cannot have it both ways. Either he arbitrarily and capriciously withheld H9, a vital laboratory commodity from selected scientists, or he knowingly provided a possibly contaminated cell line to several scientists with no warning to them of the potential pitfalls they faced in using the line.
The selective withholding of the H9 cell line and the restrictions placed on its use compounded the harm from the failure of Gallo/Popovic to disclose the true origins of the cell line, i.e., HUT-78, at a time when ready availability of the first published cell line permissive for HIV might have significantly advanced AIDS/HIV research. Writing in the journal Science, noted virologist Albert Sabin said this about the utility and origins of H9:
"According to a special National Institutes of Health (NIH) committee chaired by Alan Rabson of NCI, the H9 cell line was identical with HUT-78. This is not a trivial or irrelevant matter, as it was called by Gallo and Popovic, because the use of such uncontaminated, continuous lines of human T4 lymphocytes was crucial to the regular isolation of the new retrovirus from patients with AIDS and to the development of the antibody test by which it was possible to establish the etiological association of the virus discovered by Montagnier and his colleagues and of subsequently isolated viruses related to AIDS" (1990, p. 466).
Concerning the restrictions imposed by Dr. Gallo on the transmittal of H9 to other scientists, the Richards Committee said this:
"We consider failure to distribute uninfected H9 cells freely after publication of the article by Popovic et al. to be essentially immoral in view of the growing seriousness of the AIDS epidemic" (p. 3).
For a few select scientists, Dr. Gallo crafted a one-of-a-kind transfer agreement, tailor-made to restrict as tightly as possible the use of his cell lines and reagents by the recipient. Some of these agreements prohibited certain kinds of research. Others, like the agreement created for Harvard University's Dr. James Mullins, itemized the only kinds of research that could be done. Specifically, Mullins' transfer agreement specified that he could obtain the uninfected H9 cell line only by agreeing in advance to the following:
"Use of H9 will be limited to my immediate laboratory for the specific purpose of transfection of CTV and HTLV-I DNA. No other experiments will be carried out with this cell line without prior discussions with Dr. Gallo."
Even more restrictive was the collaboration provision developed for the transfer agreement for Harvard University's Dr. William Haseltine. (LTCB records show this restrictive provision was crafted by Dr. Gallo's close associate, Dr. Flossie Wong-Staal. It also appears that Dr. Wong-Staal, with Dr. Gallo's knowledge and approval, crafted the restrictive provision imposed on Dr. Mullins -- cited above.) The collaboration restrictions imposed on Dr. Haseltine were daunting. They not only specified the LTCB scientists with whom collaboration was mandated, they also -- as was true for Dr. Mullins -- limited the kinds of research Dr. Haseltine was able to perform with the LTCB's materials:
"Work performed will be on a collaborative basis with Dr. Gallo, Dr. Popovic, Dr. Wong-Staal, and their colleagues (to be specified by them) for the specific purpose of studying expression of HTLV-LTR linked genes in these cells. No other experiments should be initiated with these cells without prior discussion with the above named people."
For Malcolm Martin and the CDC scientists and only for these individuals, whom Dr. Gallo knew possessed LAV, there were special restrictions added to the transfer form required of most scientists who sought the infected cell line (Dr. Martin did not request the infected line, but Dr. Gallo "offered" it to Martin at the same time as he [Gallo] refused to provide him the uninfected line).
One of the special restrictions common to both Martin and the CDC scientists, said this:
"Work with HTLV-III will not be published without prior approval by Dr. Gallo."
The second special restriction had this element in common to both Martin and the CDC scientists:
"Reagents will not be used in comparisons with other viruses."
For the CDC scientists, there was an additional condition:
"They [Gallo's materials] will only be used for seroepidemiologic studies and blood bank assays."
Dr. Frederick Murphy, in a June 11, 1984 memorandum he wrote to CDC Acting Director, Dr. Walter Dowdle, gave a vivid description of the meeting with Dr. Gallo at which Gallo reportedly threatened he would not provide the CDC scientists the HIV research materials they were seeking:
"... it was a tense moment, fraught with the possibility of non-delivery. Our tack, stated orally in several different ways as we discussed the matter with Dr. Gallo, was that public health purposes were paramount. Dr. Gallo agreed. In our conversation, it became clear that comparison of his HTLV-III prototype with the French prototype LAV occupied a separate niche -- the comparison was seen as having both academic and public health purposes. Because of the latter, I offered, using several tacks, to have certain comparative tests between his HTLV-III and the French LAV done at CDC; Dr. Gallo declined each time, stating that such would be done in his lab. It was quite clear from our discussion that this was the only subject which engendered such difficulty -- when we switched to other themes ... there was no problem."
Dr. Murphy also said he understood the prohibition on "comparisons with other viruses" to mean comparisons with LAV.
B. Practices at NCI, NIH and PHS
It is clear that the impetus for selective withholding and imposition of restrictive conditions of LTCB research materials came initially from Dr. Gallo. But it is equally clear that for a prolonged period, Dr. Gallo's superiors at the NCI, particularly Drs. Fischinger and DeVita, gave Gallo license to give and withhold his materials at will. It also is clear that at the PHS level, Dr. Lowell Harmison institutionalized the selective withholding of research materials, as a matter of political and commercial policy.
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It is unclear what "alternative dissemination methods" might have adversely affected HHS' five blood test licensees. But the mere inclusion of this provision in DeVita's letter is revealing with respect to NCI/HHS' motives in restricting access to the LTCB's research materials, i.e., to protect "our current licensees." Moreover, it is clear that in other significant respects, HHS was more-than-zealous in its protection of its licensees, even at the cost of public health (see below).
Concerning the policy on the uninfected cell line, the codification of the provisions that placed release of the line "at Dr. Gallo's discretion" clearly refutes Dr. Gallo's assertion that the materials transfer restrictions were forced on him by higher officials. The codification also is noteworthy, considering that Dr. Wyngaarden, at least, was on notice that there were problems with Dr. Gallo's inequitable release of the line. In light of Dr. Gallo's demonstrated inequitable conduct, the provision vesting authority for releasing the line at "Dr. Gallo's discretion" provision was clearly at odds with Dr. Wyngaarden's dictum, recorded in the minutes of the June 18 NIH AIDS Executive Committee meeting, that,
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Dr. Fischinger told Subcommittee staff he believed that Dr. Gallo, as a Federal employee, had a "special responsibility" to make his materials freely available. Dr. Fischinger said, concerning the restrictions Dr. Gallo placed on Malcolm Martin and CDC's receipt of his cell lines, "IwouldnI wouldn't do it, but Bob must answer for himself." Dr. Fischinger was adamant on one fundamental point:
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As for DeVita, he expressed himself more vividly, saying that "Allrestrictions All restrictions are anti-science." Shown the restrictions Gallo placed on Malcolm Martin and the CDC scientists, Dr. DeVita's response was, "I think it's terrible."
C. The Unique Role of Dr. Lowell Harmison
Dr. Lowell Harmison alone, to this day, defends Dr. Gallo's imposition of restrictive conditions on his research materials, particularly relating to the CDC. Dr. Harmison's statements in this regard seemed to reflect Dr. DeVita's observation that by the Summer of 1984, Dr. Harmison had "assumed ownership of" Gallo.
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