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Duesberg on AIDS- The Gallo Case- Part 3
Viewpoints > The Gallo Case > Part 3
The Gallo Case- Part 3 Part 1 Part 2 Part 4 Part 5
Part 3 - Contents
X. A LETTER TO LEADERS OF SCIENCE pp 467-468
XI. A REPORT BY THE HHS OFFICE OF RESEARCH INTEGRITY (ORI) pp 469-479
XII. THE HHS APPEALS BOARD pp 480-522
Note: Page numbers refer to corresponding pages in the paperback edition of the book "Challenges"
Part 3- Contents pg. 467
X. A LETTER TO LEADERS OF SCIENCE
Following the exchange with Gallo, I wrote on 30 November 1992 to leaders in science, pointing to what I regarded as a scandalous situation created by the NIH reports. Allan Bromley at the time was Presidential Science Advisor, on leave from Yale.
To: Allan Bromley
Louis Sullivan, Secretary HHS
James Mason, Assistant Secretary HHS
Bernadine Healy, Director, NM
The Council, National Academy of Sciences
Frank Press, President, National Academy of Sciences and others
1. The handling of the Gallo case (among others) by the leaders of science has been a profound mess. The leaders' failures of responsibility force individuals either to accept that things are going to get worse before they get better, or to spend an inordinate amount of time and effort documenting these failures and attempting to deal with them. Expanding such time and effort detracts from doing science.
2. I enclose a letter which Gallo wrote to me. In reviewing the evidence to write my reply, and especially reviewing the OSI Draft Report of June 1991 and the OSI Report of March 1992 as reported in the media, I was struck by an aspect of these reports, namely:
(a) The OSI Reports, supported by the NIH scientific advisers, found that Gallo and his lab engaged in a number of practices, specifically: "lack of laboratory records ... lack of attention to details which resulted in false representation ... lack of scientific rigor ... breached overall responsibility ... to ensure the accuracy of the paper ... created and fostered conditions that give rise to falsified / fabricated data and falsified scientific reports. . . . "
pg 468
(b) At the same time, the OSI investigators and two out of three NIH scientific advisers (other than the Richards Panel) declared that there was no "misconduct" on Gallo's part, in the technical sense defined by the Public Health Service, namely "other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research." However, the OSI investigators and all three NIH scientific advisers judged that these practices "merit significant censure" in the conclusions of the OSI Draft Report.
Therefore, a remarkable conclusion follows from the logic of the OSI investigators and the two NIH scientific advisers, to wit: a number of practices which merit "significant censure" in the OSI Draft Report, and are listed above in boldface italic, do not seriously deviate from those that are commonly accepted within the scientific community. Since the '"significant censure" was deleted from the OSI Report of March 1992, one can further conclude that according to revised and more current views, these practices, which do not seriously deviate from those commonly accepted within the scientific community, also do not merit "significant censure."
3. Instead of actively doing something about this situation, which I regard as scandalous, the leaders of science are continuously engaged in obfuscations and evasions of responsibility. I conclude that the failure of the scientific community's leadership, whether in government agencies such as NIH and HHS, or the NAS, has been monumental. You are in a position to make a difference. I challenge you to do so.
Part 3- Contents pg. 469
XI. A REPORT BY THE HHS OFFICE OF RESEARCH INTEGRITY (ORI)
§1. Conclusions of the ORI Report
The HHS Office of Research Integrity (ORI) on 30 December 1992 issued a report which agreed with some findings and reversed other findings of the OSI Report and NIH Director Healy.
In Crewdson's articles, he did not make allegations. He reported factually, but the facts raised questions and issues perceived in various ways by different people. At the end, the ORI Report lists several conclusions concerning some of the issues raised by Crewdson's reporting, and asserts (pp. 52-53): "ORI concurs with the OSI finding that Dr. Gallo did not commit scientific misconduct in relation to the several issues in the Chicago Tribune article, and the noted discrepancies or issues raised by the 1984 Popovic paper (with the exception of the statement that LAV had not been put in a permanent cell line, discussed in the preceding section). However, ORI believes that many of Dr. Gallo's actions reflect a pattern of conduct that must be censured even though they do not constitute scientific misconduct." The ORI Report goes on to list four items (p. 53) which they judge deserving "censure."1 The first item concerns the role played by Gallo
Footnotes for page 469
1 The four counts I have quoted from the ORI Report were well summarized systematically at the end of the article:
'"Federal Inquiry Finds Misconduct By a Discoverer of the AIDS Virus," New York Times, 31 December 1992, p. Al.
The ORI Report received extensive coverage in the press. I list a few more articles here:
"'New HHS Report Faults AIDS Researche"' Washington Post 31 December 1992, p., A4.
"'U.S.: Top AIDS scientist guilty of misconduct", Chicago Tribune, 31 December 1992, p. 4.
"'Righting the record on AIDS research," editorial, Chicago Tribune, 31 December 1992.
'"HHS: Gallo Guilty of Misconduct," Science, 8 January 1993, p. 168.
"US report finds NIH's Gallo guilty of misstatement," Nature, 7 January 1993, pp. 3, 4.
"Gallo on the rack--The latest government pronouncement raises questions about the office itself as well as about Gallo," editorial in Nature, 7 January 1993, p. 1.
as a reader - referee for a scientific article submitted by French scientists from the Institut Pasteur, including Montagnier (head of the laboratory), and Francoise Barre-Sinoussi (one of the principal researchers), whose name appeared first on the paper. This first item listed states:
-Dr. Gallo's role in the Barre-Sinoussi paper: OSI found that Dr. Gallo's actions were "gratuitous, self-serving, and improper." It was the admission by Dr. Montagnier that he may have seen the galley proofs for the article, and did not raise any objections to the material added by Dr. Gallo, that led ORI to conclude that Dr. Gallo's actions did not constitute scientific misconduct. Nonetheless, ORI believes that Dr. Gallo's actions reflect Dr. Gallo's propensity to misrepresent and mislead in favor of his own research findings of hypotheses.
The other three items read as follows ("LTCB" refers to Gallo's laboratory, Laboratory of Tumor Cell Biology). -Dr. Gallo's failure to fulfill his obligations as the senior author: In light of his role as senior author of the Popovic paper, Dr. Gallo must bear substantial responsibility for the numerous discrepancies in the Popovic paper, including the four instances of scientific misconduct attributed to Dr. Popovic The scientific and public health importance of the research undertaken in the LTCB imposed an obligation for accuracy in reporting the methodologies and results of this groundbreaking research--an obligation that Dr. Gallo failed to meet.
-Supervision of the LTCB by Dr. Gallo: Especially in light of the groundbreaking nature of this research and its profound public health implications, ORI believes that the careless and unacceptable keeping of research records revealed by the OSI inquiry and investigation reflects irresponsible laboratory management that has permanently impaired the ability to trace the important steps taken.
-Failure to determine the source of [the cell line] H92 in a timely manner, and restrictive conditions on access of other researchers to H9: Dr. Gallo's failure to determine in a
Footnotes for page 470
2 The cell line H9 was "the permanent cell line in which HTLV-III grew," according to the ORI. p. 51.
timely manner the derivation of the cell line that supported the HTLV-IIIB culture and the imposition of restrictive conditions on its distribution reflect Dr. Gallo's indifference to acknowledging promptly the contributions of others and to sharing of research materials of critical public health importance.
These conclusions were followed by two summary paragraphs (p. 54), concerning broader implications of Gallo's scientific practices. I reproduce these paragraphs in full: Overall, ORI finds that the events surrounding the discovery of the AIDS virus and the development of a blood test are highly regrettable and unfortunate. The scientific trail of evidence for findings of such profound public health importance is so muddled that the source of a critical cell line remained uncertain until well after publication of the Popovic paper, and the source of a critical viral isolate (MOV) remains unknown. A disregard for proper scientific record keeping in groundbreaking research played a major role in this failure.
Furthermore, a failure to fully disclose all aspects of the research, and a propensity to exaggerate LTCB accomplishments, undermine the legitimate and important accomplishments of Dr. Gallo and Dr. Popovic. ORI believes that Dr. Gallo and his research team were instrumental in identifying the AIDS virus and protecting the blood supply from contamination with the virus. To have these critical accomplishments diminished by the actions documented in this investigation is a tragedy for science, and for Drs. Gallo and Popovic.
The ORI Report made a distinction between certain issues on which Gallo should receive "censure' as in the above four counts, and another on which Gallo was guilty of "scientific misconduct," as we shall discuss below. This distinction was to haunt ORI in its dealings with the HHS Appeals Board later. Compare with the "Offer of Proof' to the Appeals Board, excerpts from which are reproduced in Appendix 3 of the next part. In this "Offer of Proof,' ORI attempted to tighten and upgrade its evaluation from "censure" to 'misconduct,' and generally used stronger language.
Aside from being aware of items giving general conclusions such as those listed above, I think it may be useful for readers also to be aware more specifically of the way the ORI Report analyzed some of the points of contention. The French virus called
pg 472
LAV was at the center of attention, because of the possibility that it was misappropriated by Gallo. Especially, a question was raised as to the relation between the virus HTLV-IIIB alleged by Gallo to have been grown in his laboratory, and the French virus LAV. Gallo with several coauthors, notably Popovic, after whom the article is named, had published an article in Science, in which they claimed to have discovered a method to grow the AIDS virus continuously in a cell line.3
The misappropriation issue. The ORI Report describes the first of its specific concerns as follows (p. 11):
(1) Did HTLV-IIIB's affinity to LAV reflect a misappropriation of LAV or an accidental contamination of the 'pool' culture? A corollary issue was whether the LTCB had other HIV isolates available that could have been used to develop the AIDS blood test on approximately the same timeline as development of the test with HTLV-IIIB.
On this first issue, after reviewing evidence, the ORI came to the conclusion (p. 28): 'ORI supports the OSI finding that it is not possible to resolve the question of misappropriation versus contamination."
A questionable statement concerning LAV. The second main issue of concern to ORI concerned a statement which Gallo had written in the article:4
These findings suggest that HTLV-III and LAV may be different. However, it is possible that this is due to insufficient characterization of LAV because the virus has not been transmitted to a permanently growing cell line for true isolation and therefore has been difficult to obtain in quantity.
Footnotes for page 472
3 The article is entitled 'Detection, isolation, and continuous production of cytopathic retroviruses (HTLV-III) from patients with AIDS and pre AIDS,' by Mikulas Popovic, M. G. Sarnghadaran, Elizabeth Read, and Robert C. Gallo. This publication is referred to through the ORI Report as 'the Popovic paper."
4 Despite the fact that there were several coauthors, the ORI Report states (p. 46): "ORI finds Dr. Gallo wrote the disputed statement and is responsible for the concomitant scientific misconduct.'
The ORI concern was then expressed as follows (p. 12) (2) Was the statement in the Popovic paper that LAV had not been transmitted to a permanently growing cell line a falsification of the status of LAV research?
The ORI Report asserts (p. 29): "The underlined statement is a misrepresentation. LAV had been transmitted to a permanently growing cell line within the LTCB by the authors of this statement. After reviewing the available evidence, OSI found that LAV had been grown in a permanent cell line in the LTCB several months prior to the writing of that statement. Dr. Gallo asserted that the clause, 'because the virus has not been transmitted to a permanently growing cell line," was not false because it did not refer to the accomplishments of the LTCB, but referred to the accomplishments of the French researchers. Dr. Gallo alleged that when the statement was written, the French had not grown LAV in a permanent cell line. The OSI experts could not agree on the proper interpretation of the clause; some believed that it referred solely to the French, others believed that it indicated that no laboratory had grown LAV in a permanent cell line. OSI found that the statement was a misrepresentation but did not find Dr. Gallo guilty of scientific misconduct stemming from this allegation....'
However, ORI came to a different conclusion from OSI since its report asserts (p. 43): "In sum, ORI finds that Dr. Gallo falsely reported the status of LAV research when he wrote the statement, and this constitutes scientific misconduct. The explanations that Dr. Gallo preferred for the statement are neither credible when the evidence is considered, nor do they vitiate the impropriety of falsely reporting the status of LAV research in the Popovic paper. Even if the statement can be technically interpreted to refer to the accomplishments of French researchers, an interpretation that ORI disputes, ORI believes that Dr. Gallo is guilty of misconduct because the statement is intended to mislead the research community with respect to the ability of LAV to be grown in a permanent cell line and, thus, constituted falsification in reporting research."
In this evaluation, the ORI came to the same conclusion as the Richards Panel, which they quote in the report (p. 50): 'The statement that LAV had not been transmitted in a permanent cell line is simply false, and was known to be false at the time the paper was written. This is one of the most glaring faults in the paper and is part of the pattern of misrepresentation in the discussion
of the problem of continuous culture. There is no way in which Dr. Gallo can be excused from sharing the blame for this misstatement."
Not all scientists shared the point of view of ORI or of the Richards Panel. For an example, I quote from Science (8 January 1993, p. 170):' In spite of such protestations [by Gallo's lawyer against the ORI Report], even some of Gallo's allies aren't buying the line that he did nothing wrong. Nobel Prize-winning retrovirologist Howard Temin of the University of Wisconsin concedes Gallo was wrong not to describe the lab's use of LAV. 'That's clearly improper;" says Temin. He also calls Gallo's reasons for not describing that work in the paper 'obviously silly' and says ORI was "quite right to reject them.'
Still, says Temin, the ORI Report comes to a "very unfortunate" conclusion because Gallo's behavior, though not collegial, was not misconduct. Temin says he believes misconduct applies to researchers who have falsified "a major thing." In the Gallo case, the misrepresentations were "minor things" says Temin--things that did not affect the paper's conclusions. Temin argues that Gallo's transgressions were a matter of denying credit to a competitor--not serious falsification. Temin also strongly objects to ORI's conclusion that Gallo's failure to describe having cultured LAV impeded other researchers. 'LAV and IIIB are the same," he says. Whether researchers got their samples "from Gallo or Montagnier couldn't have made any difference in the world.'
§2. A Statement by Gallo
The findings of HHS were reported at length in the press, and notably in Crewdson's article "U.S.: Top AIDS scientist guilty of misconduct' in the Chicago Tribune of 31 December 1992. The article was accompanied by a Gallo statement, which deserves to be reproduced here in full: After reviewing everything I and my colleagues have ever published on the discovery of the AIDS virus and the development of the AIDS blood test, ORI could only take issue with a few trivial mistakes and a single sentence Written by me.
The new and extraordinary finding that the sentence I wrote is false is utterly unwarranted. It is based on a distorted interpretation of the sentence. Numerous NIH scientists believe the sentence means what I intended for it to say, as did the co-authors of the article and previous OSI scientific reviewers.
For the record, I intend to appeal this finding in the ORI Report and expect to have the finding overturned.
On a broader level, this endless and incompetent government investigation should be of concern to everyone seeking to advance medical knowledge. My laboratory's contributions to the advancement of medical science are undisputed. For the past three years, however, I have spent a substantial amount of my time responding to issues involving the OSI and ORI investigations. These investigations have diverted not only my personal time and the time of others in my laboratory, but, perhaps most importantly, our collective creative thinking. We cannot recapture that time. We cannot even begin to calculate the amount of potentially lifesaving research that has been lost. Those who seek to perpetuate investigations that result in petty and misguided conclusions like those in the ORI Report must account for this lost research. They must understand that, while the uncovering of genuine scientific misconduct is important, the mindless pursuit of fantasized misconduct can have devastating consequences for scientific research.
The misguided finding of the ORI Report have no bearing on the validity and importance of the research on AIDS conducted by my laboratory. My intention, while the appeal is pending, is to continue to conduct research on AIDS, cancer, and other diseases. Looking toward the future will be much more productive than reviewing the past.
pg 476
§3. "Misconduct" but Ignoring "Significant" Documents
Although the ORI Report officially used the key word misconduct," with obvious effects on the public relations platform, it was still defective in not taking into account, let alone releasing, "significant" documents from the NIH files.
There was some evidence that the ORI Report, despite concluding "misconduct" on Gallo's part in one instance, nevertheless still did not contain a substantial amount of information which was withheld in the previous NIH Report of March 1992.
Lyle Bivens, Director of ORI, had the courtesy to send me directly a copy of the report, and I then replied with a letter dated 13 January 1993, formulating criticisms of this report as follows:
Significance of the sequencing analysis. The sequencing analysis and its conclusion that 'MOV and HTLV-IIIB were identical to LAV-LAI' are mentioned only once in the ORI Report (one line, p. 13). Everywhere else in the ORI Report, the significance of this finding, even its existence, is ignored. I shall list several examples.
(a) Contamination. On page 27, the ORI Report states that 'ORI concludes conditions in the LTCB may have created an environment that resulted In LAV/LAI's contamination of other cultures. The ORI Report further concludes that the contamination could have occurred between late October 1983, when the September LAV samples were taken from the freezer, and late February 1984, when HTLV-IIIB infected the H9 cell line.' On page 28, the ORI Report states: 'ORI supports the OSI finding that it is not possible to resolve the question of misappropriation versus contamination.'
The ORI Report is misleading. Indeed, LAV/LAI is one and the same as HTLV-IIIB according to the sequencing analysis. The ORI Report gives no evidence why it supports the finding of OSI that it is not possible to resolve the question of misappropriation-, worse, it gives no evidence that ORI even attempted seriously to probe into that question.
(b) A single isolate. The ORI Report repeatedly has sentences to the effect that HTLV-IIIB and LAV are different Isolates. For example, on page 45, the ORI Report states: 'ORI notes that Dr. Gallo's failure to reveal the utility of LAV effectively ensured that
most researchers would use HTLV-IIIB in AIDS research because they would have thought it to be the only HIV isolate grown in a permanent cell line. Consequently, this virtually ensured HTLV-IIIB's preeminence in AIDS research.' Again on page 52: "in fact, as noted above, revealing that LAV could be grown in a permanent cell line would have indicated LAV's research utility, indicated that HTLV-IIIB was not the only isolate that could be used in the development of an AIDS test, and would have encouraged others to pursue the work with LAV.'
Both statements are misleading, because the statements accept that LAV was another isolate, which is not true. The most serious misrepresentation here is that Gallo said repeatedly that HTLV-III was different from LAV, and thereby misled researchers, who were not aware that the isolates were one and the same. ORI fails to even mention this misrepresentation, and thereby contributes to it. See also the next item in the same vein.
(c) Recognition by Gallo-Popovic that LAV is HTLV-III. On page 34, the ORI report quotes an early version of the Popovic manuscript, including one passage which Gallo deleted, but unfortunately the ORI Report f"s to quote another even more crucial passage deleted by Gallo, to the effect that LAV "is described here as HTLV-III'. This is a serious omission from the ORI Report.
(d) Misreporting of evidence. On page 26, the report states: 'The evidence shows that neither Dr. Gallo and his colleagues nor the Pasteur scientists knew before 1991 that LAV/LAI had been present in the LTCB since September 1983.'
This sentence is misleading, as shown by the Popovic sentence mentioned in the preceding item, that LAV "is described here as HTLV-III.' This sentence dates back to Fall 1983, and shows that Popovic and Gallo did know that LAV had been present in the LTCB in 1983. Gallo and Popovic received several samples of LAV/BRU. One of these samples had unknowingly been contaminated with LAV/LAI at the Institut Pasteur. The fact that Gallo and Popovic were not aware they were working with LAV/LAI is irrelevant, because they were working with LAV/BRU, and they knew it well.
(e) MOV. On page 17 the ORI Report states: "Another isolate, MOV, had been growing in a permanent cell line since November 1983. On 6 January 1984, MOV became the first retrovirus to be used in ELISA tests by Dr. Sarngadharan.'
Calling MOV 'another isolate' is misleading, because the sequencing analysis found that MOV is LAV.
The whole discussion about MOV (pp. 17, 19, 20, 2 1) ignores this finding, and is therefore misleading. The conclusion that MOV became the first retrovirus to be used in ELISA tests by Dr. Sarngadharan, combined with the fact that MOV is LAV, shows that the French virus was the first one used for their blood test. This conclusion deserved to be stated clearly in those terms in the ORI Report, but it was not so stated.
Withholding of documents. Although the ORI Report corrected some defects and failures of the OSI Report listed in the 'Dissent and Critique' of the OSI Report by Suzanne Hadley, nevertheless it perpetuated some of the major flaws of the OSI Report, as exemplified above. The ORI Report was still far from satisfactory, and only represented a second stage in the evolution of the HHS investigative process, after Suzanne Hadley had been dismissed by Bernadine Healy. For a further evolution, readers can see the 'Offer of Proof' prepared by ORI for the Appeals Board, even though this "Offer of Proof' was ultimately not used. (See Appendix 3 of the next part.)
Even more seriously, the ORI Report was unsatisfactory because certain crucial documents were still not being mentioned, let alone released. Indeed, the "Dissent and Critique" of the OSI Report reported in Dan Greenberg's Science and Government Report of 1 June 1992, stated: Material apparently damaging to Gallo, including some of his own testimony, has been deleted. Specious, unsubstantiated arguments adduced by Gallo and his colleague, Mikulas Popovic, have been accepted unquestioningly by OSI. The OSI even constructed its own arguments exculpatory to Gallo.
A number of OSI arguments and conclusions cannot be substantiated-, a number are flatly refuted by the evidence. Moreover, in a number of instances, OSI has failed to deal with and even mention highly significant pieces of evidence known to be in its possession. Perhaps most serious, the final OSI Report gives only superficial, misleading consideration to the implications of the highly significant virus sequencing studies. As a result, the OSI has irresponsibly evaded the central question in the entire investigation, the question of Gallo's possible misappropriation of the Institut Pasteur HIV isolate, LAV.
Even with their ongoing evolution, the ORI Report made no mention that NIH had in its possession additional documents that are 'highly significant.' These documents were also withheld from the Richards Panel. It was ORI's responsibility to consider these documents, but the ORI Report gives no sign that ORI has taken these documents into consideration. Certainly the ORI Report did not mention these documents, and a fortiori it did not make them available to the scientific community.
§4. My Conclusions
As we shall see in connection with an ongoing investigation by the Subcommittee, Dingell has asserted publicly that he was able to obtain documents which NIH systematically tried to withhold, although as late as June 1993, he had not been able to obtain all such documents. (See his public opening statement at the hearings of 21 June 1993, reproduced in its entirety below.) Therefore one can raise the following questions:
1. Concerning HHS and NIH: Did HHS withhold documents from its own Office of Research Integrity? Did NIH withhold such documents? Were higher-ups at HHS (Secretary and Assistant Secretary) aware that such documents were withheld by NIH If they did not withhold such documents themselves?
2. Concerning ORI itself: Was ORI aware that such documents were withheld? If yes, why was such withholding not stated in the ORI Report? If no, what trust can be placed in an office which is so manipulated by others in its own organization?
3. Concerning the scientific community: How can the scientific community rely on official bodies (NIH, HHS-ORI, Richards Panel) to get complete documentation and information concerning the Gallo case?
My answer is that it cannot. Different scientists come to different conclusions, depending on different attributions of importance to different factors.
The scientific community could not rely on the Dingell Subcommittee either, since they never issued a formal report. The next best thing was a Staff Report, prepared with the cooperation of Suzanne Hadley, see below.
Part 3- Contents pg. 480
XII. THE HHS APPEALS BOARD
Various appeals from ORI were considered by the HHS Appeals Board, among which were the appeals by Popovic and Gallo. The ultimate dependency of the NIH and HHS investigations on the Appeals Board finished the long process of eliminating scientists from the review of the Gallo case, and turning it over to lawyers, whose point of view is legalistic, not scientific. Some people have called this "due process." I shall list here some of the conditions imposed by the Board on ORI in July 1993.
§1. Legalistic Rulings
The Board made legalistic rulings whose effect is to institutionalize certain low standards of behavior and to make it difficult to enforce higher standards of behavior.
(a) The Board found that 'anticipatory writing" (claiming that experiments were performed when in fact these experiments were not performed) in an NIH grant application is NOT scientific misconduct. 1
Footnotes for page 480
1 One decision in this respect had to do with the case of Rameshwar Sharma. According to the Washington Post ('U.S. Loses Science Fraud Case on Appeal,' 11 August 1993, p. A13): 'In an Internal Investigation, Sharma's employer, the Cleveland Clinic Foundation, found that the scientist had made misstatements but that he had not committed intentional fraud. He had engaged in 'anticipatory writing--claiming to perform certain experiments that would soon be performed.' According to the Washington Post ' ORI proposed disciplinary actions against Sharma that Included excluding him from Public Health Service advisory boards for three years and holding any of his applications during that period to a higher standard of review.' However, again according to the Washington Post . the appeals panel reported that 'we find that ORI failed to carry its burden or proving scientific misconduct by a preponderance of the evidence" and that 'ORI's findings are not supported and the proposed administrative actions are not justified.' An aide to Dingell is quoted as commenting: "It's a very curious finding. Is this an admission that falsification of a grant application is okay?'
(b) By a ruling of the Board, ORI must not only prove that scientific misconduct occurred, but ORI must also prove the absence of honest error relative to the alleged misconduct, i.e., ORI must prove a negative.
(c) The Board ruled that falsification, fabrication, and the like are not grounds for a finding of scientific misconduct unless the respondent 'reasonably could have anticipated at the time of his alleged conduct that such conduct, if proved, would constitute ,scientific misconduct."
(d) The Board ruled that scientific misconduct does not include 'falsification or any other conduct which does not seriously deviate from commonly accepted practices within the scientific community....' According to the Board's logic, if falsification becomes a universal practice among scientists, then it receives the legal approval of government agencies which are supposed to overview the maintenance of scientific standards for government grants and government laboratories.
Informative analyses of these impositions by the Appeals Board are given in the articles 'Hearing Process Proves a Challenge for ORI" (Science, 18 June 1993, p. 1714), and 'Case Against Gallo Faces Tough Appeals Process" (Science and Government Report, 15 October 1993). Extensive excerpts from the conditions set by the Appeals Board on ORI will be reproduced in an appendix, so that readers can verify for themselves what ORI was subjected to, especially with respect to what is called an 'offer of proof' for ORI's allegations. Among other things, HHS was under the threat of a lawsuit if its ruling did not meet certain legal criteria. Indeed, one of the conditions stated: 'If we do not receive such an offer of proof with respect to each allegation, we would dismiss this proceeding with regard to that allegation. To do otherwise would result in this department committing its resources for a proceeding which could not lead to a legally supportable result in ORI's favor.'
The focus of the HHS adjudicative process shifted considerations from those of scientific standards to legalistic manipulations. Scientists were not participating.
(a) The Federation of American Societies for Experimental Biology (FASEB) declined an invitation of ORI to participate at the hearing stage, because according to Science (18 June 1993, p. 1714), 'the process was more judicial than scientific...,' among other reasons.
(b) At first, the Board refused to include a scientist as a member, even though the Board's rules specifically provide for this option, and ORI even requested it. The Board consisted only of government attorneys.
pg 482
This same issue of Science also reported the reaction of ORI officials: 'ORI director Lyle Bivens acknowledges that the appeals process is not working in the way he envisioned it. Bivens says he hoped that the Board would have included scientists, rather than a solid cast of government attorneys. Indeed, he says, he is 'disappointed' by the failure of ORI's early efforts to get the active participation of the scientific community at the hearing stage, as opposed to during Investigations."
The Gallo investigative process started with HHS soliciting the National Academy of Sciences for the nomination of a panel 'with a view to ensuring both the fact and appearance of objectivity." As NIH Acting Director William Raub wrote to Fred Richards 16 April 1990: 'Throughout, your expertise, independence, and objectivity will be key elements in ensuring a thorough and fair review." Then the NIH-HHS process ran its full course whereby the scientists were manipulated, information was withheld from them, and finally they were completely eliminated and put down at the time the Appeals Board issued certain of its rulings (cf. Appendix 1).2
§2. The Popovic Exoneration
Popovic was the first named author of the Science article under questioning. As summarized in the article "Popovic is Cleared on All Charges; Gallo Case in Doubt' (Science, 262, 12 November 1993, p. 982):
ORI's case against Popovic boiled down to his statement that certain experiments were 'not done' when they had in fact been done, 3 that a '10% figure in a table was not supported by data," and that he claimed that certain fluids were 'first shown' to contain signs of virus replication before they were mixed together, when that was not the case. The Board noted that none of these alleged misrepresentations would have made any difference to the conclusions of the paper.
Footnotes for page 482
2 Subsequently, as reported in Science (12 November 1993, p. 982): 'if the [Gallo] hearing is held, the Board's three government lawyers will be joined by a scientist, Jules Younger, an emeritus virologist at the University of Pittsburgh. Both sides requested the addition of a scientist as a full voting member of the board.'
3 See below for further comments on this "Not Done' in connection with the Richards testimony; and also Appendix 2 where I quote a more extensive passage &from the ORI's comments on the 'Not Done' question.
pg 483
Popovic was completely exonerated by the Appeals Board, which even criticized the ORI by stating: "One might anticipate that from all this evidence, after all the sound and fury, there would be at least a residue of palpable wrongdoing. That is not the case.'
Faced with the Popovic verdict, ORI Director Lyle Bivens was quoted in the Chicago Tribune (5 November 1993, p. 18): "My initial reaction is one of outrage. The Board is way off the mark."
Raising new charges. As already documented, the ORI Report did indeed suffer from serious defects.
(a) The defects were partly due to incompetence on several counts, some of which I myself criticized in the manner described previously in Part XI.
(b) A problem arose from ORI having determined that some actions were not 'misconduct' but did merit 'censure.' From the point of view of the Appeals Board, only the legalistic category of 'misconduct' had any relevance to their ruling (see for instance the precise quote below).
(c) The defects of the ORI Report were also partly due to NIH withholding from ORI information in the NIH files, as well as ORI's de facto inability to go after this information, or to ask the proper outside sources for this information (e.g. Suzanne Hadley). Bernadine Healy's dismissal of Suzanne Hadley from the investigation had successfully derailed the investigation.
Partly because various sources criticized the ORI Report, and partly because the ORI staff was genuinely trying under difficult circumstances, ORI attempted to improve its case for presentation to the Appeals Board. For instance, it attempted to bring up new evidence, and to upgrade certain actions from meriting censure to actual misconduct. The matter was reported as follows in the article 'U.S. may not fight appeal by Gallo" (Chicago Tribune, 10 November 1993, p. 1): "For most of the past year, four ORI lawyers have worked virtually full time in preparing to argue the Gallo case, which is detailed in a 99-page offer of proof, or "proffer,' they submitted to the Appeals Board last August.,4
Footnotes for page 483
4 Having learned of this "Offer of Proof' from Crewdson (see also Dan Greenberg's "Case Against Gallo Faces Tough Appeals Process'), Science and Government Report 15 October 1993), I wrote to ORI for a copy, which I received by return mail. I shall reproduce excerpts from this 'Offer of Proof' in Appendix 3. Since the document was not mentioned in magazines such as Science. I distributed 30 copies, and also sent a copy to the Council of the National Academy of Sciences, as well as to Ellis Rubinstein, news editor of Science.
pg 484
The price of getting entangled in legalistic categories became explicitly apparent in the confrontation between ORI and the Appeals Board. The Appeals Board rejected the ORI's attempt to improve the case, and the Appeals Board's decision stated (p. 72):
During the course of the hearing and in post-hearing briefs, ORI attempted to raise other issues concerning the accuracy of the Science paper. We found introduction of these issues to be inappropriate and untimely. In effect, ORI was attempting to reopen allegations of misconduct on which it had not made findings of misconduct in the final report which served as the basis for this proceeding. While ORI attempted to characterize these matters as merely going to Dr. Popovic's credibility, ORI had not even identified these matters as part of the pattern of conduct it said (in the Offer of Proof submitted several weeks prior to the hearing) it would show to prove Dr. Popovic's intent. Thus, Dr. Popovic did not have fair notice that these issues would be addressed, and we ruled that they were outside the scope of this hearings.5
The attempt to present an improved case was subsequently described as follows in "The Aftermath of the Gallo Case" (Science, 263, 7 January 1994, p. 22): 'in interviews after the Popovic decision, ORI also contended that the Board refused to hear evidence of a 'pattern of behavior' to prove intent in the Popovic case. But Rebecca Dresser, a misconduct expert [sic] at the Case Western Reserve University Law School who examined the Appeals Board decisions at Sciences request, says the Board drew the line only when ORI tried to raise a serious charge not in its investigative report.'
At the same time, Science did not give any indication to its readers concerning the substance of the issues, listed extensively in the ORI 'Offer of Proof.' (See Appendix 3.)
Footnotes for page 484
5 The paragraph continues: "We nonetheless discuss these issues briefly here since ORI continued to press them and since they were raised in a public forum.'
pg 485
§3. Dropping the Gallo Case; Press Reports
The Chicago Tribune article of 10 November 1993 (mentioned above, page 10) reported: 'ORI officials acknowledged there was nothing to prevent them from opening a new and broader investigation of Gallo based on evidence that has come to their attention since the NIH investigation was concluded. But they admitted that such a decision might cast them as 'zealots who are tormenting this guy.'"
Given the legalistic conditions imposed by the Appeals Board, their exoneration of Popovic, the apprehension about being cast as 'zealots who are tormenting this guy,' and a basic disagreement about "standards,' ORI dropped all charges against Gallo. ORI Director Lyle Bivens went on the record against the ruling of the Appeals Board (HHS press release dated 12 November 1993). For instance, as reported in the New York Times (listed below) the Office of Research Integrity stated that it was dropping the charges chiefly because the Appeals Board 'now applies different standards from those applied by the Office of Research Integrity ... ORI maintains that the standards applied by the panel reflect a fundamental disagreement with ORI as to the importance of clarity, accuracy, and honesty in science. However, because ORI is bound by the panel's decisions, it will not continue its proceeding against Dr. Gallo."
Thus the Appeals Board never issued a decision on Gallo himself. The ORI dropping of charges against Gallo was widely reported in the press. I list a few articles here. 'Misconduct Charges Dropped Against AIDS Virus Scientist," New York Times, 13 November 1993, p. 1.
"Misconduct finding against Gallo dropped," Chicago Tribune, 13 November 1993, p. 1.
'Case against AIDS scientist dropped," Washington Post, 13 November 1993, p. 1.
"Misconduct charges against Gallo withdrawn after Popovic decision," Nature, 18 November 1993, p. 19 1.
"ORI Drops Gallo Case in Legal Dispute,' Science, 19 November 1993,p.1202.
"Victory at Last for a Besieged Virus Hunter," Time, 22 November 1993, p. 61.
The New York Times and Chicago Tribune articles reported Gallo's statement: 'I am delighted that ORI has dismissed the case against me and that I have been completely validated.
pg 486
I will now be able to redouble my efforts in the fight against AIDS and cancer. There are several avenues of AIDS research that my laboratory is pursuing.'
In addition to these news reports, there were supporting articles and editorial statements, favorable to Gallo, for instance in the Washington Post and New York Times Gallo himself sent me these pieces (which I already had), accompanied with a note reading: 'Dear Dr. Lang, despite your bias, despite your antiscientific self-righteous [sic] and methods, despite your obsessive need to fulfill hate mongering--nonetheless I thought your need 'to be involved' should be fulfilled by sending you information you may have not seen or chose to ignore.' I shall quote from both these pieces.
Washington Post editorial: "Dr. Gallo: A Vindication" (1 December 1993). The Washington Post editorial concluded: 'Dr. Gallo may not be known for his modesty or retiring nature, but he is, without qualification, a dedicated and accomplished scientist who has been subject to a great deal of personal attack.... But it is now clear, even to those who have doubted it for years, that the problem [of eliminating AIDS] will not be solved politically.... It is instead a staggering scientific puzzle whose solution requires the talents and dedication of the nation's best medical researchers. Dr. Gallo and many others at NIH are among them.'
New York Times Magazine: "Method and Madness-- The Vindication of Robert Gallo," by Nicholas Wade (Sunday, 26 December 1993). The New York Times Magazine piece, by New York Times science editor Nicholas Wade, was even more favorable to Gallo. I quote more extensive excerpts, because I think this piece is very important to document the New York Times' journalism: For years, Gallo has been under a thick cloud of suspicion that he stole from French scientists the credit for discovering the AIDS virus. The suspicion has proved groundless.
As a Government Appeals Board concluded last month: "One might anticipate that from all this evidence, after all the sound and fury, there would be at least a residue of palpable wrongdoing. This is not the case."
Not even a residue?
No, and in truth, Gallo's achievement was greater than has been generally understood, since it far exceeded the mere co-discovery of the AIDS virus with which he is usually credited....
pg 487
After 12 years, Gallo's blood test is still the only weapon of real value that scientists have yet managed to devise against this baffling disease. But far from basking in gratitude, Gallo has been subjected to years of humiliation. What prompted this cruel twist of fate?
In brief, a scientific puzzle led to a newspaper attack that triggered an insatiable government inquiry. The puzzle was that the version of the AIDS virus Gallo used for his blood test turned out to have almost the same genetic sequence as Montagnier's virus.... One explanation was that the French virus had gotten loose in Gallo's lab and overgrown his own virus cultures.... The other possibility was that Gallo had used the French virus for his experiments without isolating his own, a physical and intellectual theft. Given Gallo's competitive nature and his well-known thirst for recognition, the second possibility loomed large in people's minds.
An unusual piece of reporting gave the suspicion shape. John Crewdson, a Chicago Tribune reporter who won a Pulitzer Prize while with the New York Times, spent 20 months investigating Gallo's work. His 50,000 word article of Nov. 19, 1989, described several cases in which colleagues and others believed Gallo had hogged credit for joint discoveries. Yet the article, despite its author's perseverance, had several defects.
It was relentlessly hostile to Gallo, interpreting one complex event after another to his discredit....
Nonetheless, the Crewdson article prompted an inquiry by a government office now known as the Office of Research Integrity.... But in 1991 Gallo and Montagnier solved the festering mystery. The two scientists' original viruses were indeed different strains, as Gallo had said all along.... The only evidence for assuming Gallo had appropriated the French virus promptly evaporated.
But instead of dropping the case, ORI plodded on. It claimed there were misstatements in Gallo's discovery papers, particularly in sections written by his colleague Mikulas Popovic, a Czech virologist. It accused Gallo and Popovic of 'scientific misconduct,' even while conceding the alleged misstatement was minor and 'does not invalidate" the research....
With the charge against Popovic pulverized, ORI withdrew
pg 488
its case against Gallo presumably foreseeing it would meet with equal contempt and whining that the Appeals Board had set a higher standard. In fact, it was O.R.I. that had proposed a lower one, claiming it only needed to prove a statement false to establish scientific misconduct, regardless of intent. Sorry, said the Appeals Board, the regulation defining scientific misconduct doesn't say 'false." It says "falsification," which requires proving an intent to deceive....
In Gallo's rush for the AIDS virus, he bruised many competitors. His critics mistook his sharp elbows for itchy fingers. They were far too slow to correct their misjudgment of the one scientific hero who has yet emerged in the tight against AIDS. This piece by Wade was illustrated by a drawing representing Gallo's face as a martyred saint, halo included.
Readers of the present book have plenty of documentation from which they can verify that Wade's piece misrepresents the record of the Gallo-Popovic case. I don't want to be repetitive, but I shall summarize briefly a few salient points about that piece.
- Differences between the Popovic and Gallo cases. Wade's use of the Appeals Board phrase that there wasn't even "a residue of palpable wrongdoing' in connection with Gallo is a misrepresentation. Indeed, this phrase was addressed to the Popovic case, not the Gallo case, which is completely different in several important respects. For example, Popovic in a draft manuscript of the Popovic et al. paper had written two sentences giving credit to the French: 'LAV [the French virus] as a reference virus ... had been used in the first series of experiments" and "LAV is described here as HTLV-III.' Gallo struck out both statements and wrote in the margin, "I just don't believe it. You are absolutely incredible" and "Mika you are crazy,' as I have explained in detail in my reply to Gallo. Furthermore Popovic gave the drafts of the paper with Gallo's marginal notations to his sister in Czechoslovakia, because he believed that, '... sometime in the future, I might need them as evidence to prove that I gave fair credit ...' to the Pasteur scientists. (15 May 1991 Popovic to Hadley memorandum, p. 7.)
The ORI deserves criticisms for having brought up the Popovic case instead of focusing entirely on the Gallo case, in light of the very different roles played by these two scientists. Fred Richards himself made this point explicit. For instance, Science and Government Report (15 May 1994) states: 'Richards also faulted the OSI Report for focusing blame on subordinate Popovic, rather than laboratory chief Gallo, who, Richards said, had the duty to
pg 489
'monitor the performance of all personnel in the laboratory and to pay particular attention to the accuracy of major publications which bear his name as author."
- A 'lower standard of proof'? The same issue of Science and Government Report also stated that 'Richards, who testified for the government in the Popovic misconduct hearing, describes the Appeals Board decision as 'atrocious,' a view shared by other researchers encountered by SGR. The Departmental Appeals Board is mainly occupied with cases concerning Social Security payments and eligibility, and has virtually no experience or competence in scientific issues...."
- Concerning Gallo's putative "achievement.' Wade asserted that 'Gallo's achievement was greater than has been generally understood, since it far exceeded the mere co-discovery of the AIDS virus with which he is credited.' In fact, on 11 July 1994, NIH and the Institut Pasteur revised the agreement concerning royalties for the HIV-antibody blood test, giving to the 'Institut Pasteur a greater share of the royalties. Harold Varmus, Director of NIH, stated at the time: "The acknowledgment of the role of the Institut Pasteur in isolating the AIDS-causing virus was very slow to occur.' See XVI, §3.
Readers can also compare Gallo's "achievement" with what is described in the ORI 'Offer of Proof," which states (p. 47): "The evidence will show that Dr. Gallo took a cell line identified by another scientist --'HUT-78'-- and used it to successfully, continuously grow the AIDS virus, first LAV, then LAV as 'MOV,' then the 'pool' isolate, 'HTLV-IIIb' Dr. Gallo renamed the cell line 'HT,' and when he published his findings, he misrepresented and obscured the origins of the cell line so that its true identity could not be discerned. Thereafter, for a prolonged period, Dr. Gallo failed to diligently seek out the truth about the origins of 'HT.' Even faced with important evidence from multiple sources that HT was HUT- 78, Gallo failed to acknowledge this fact to the scientific community.,
- The patent application A memorandum of the HHS Office of the Inspector General (10 June 1994) stated that the patent examiner was unaware of the extent of the French work at the time she examined Gallo's patent application, and she said that Gallo should have disclosed it. Had she known more about the situation with LAV, "she would have suspended prosecution of the Gallo application and declared an interference between the two applicants,' that is, the Institut Pasteur and Gallo. For further direct quotes from the IG memorandum, see XV.
- Concerning the reporting by the Chicago Tribune.
Comparing the statements of Crewdson in the Chicago Tribune and the official documents stemming from ORI, the HHS Inspector General and Fred Richards, I have not found any false statement or misrepresentation by John Crewdson in the Chicago Tribune.
'Sharp elbows' or "itchy fingers'? Nicholas Wade asserts that Gallo's critics 'mistook his sharp elbows for itchy fingers." At some point the scientific community, let alone readers of the New York Times, have the responsibility to decide on the available evidence. Fred Richards is quoted in Science and Government Report ('Advisor in the Gallo Case Calls for Reopening Probe," 15 May 1994): -Me major purpose of this whole investigation was to find out whether they stole the virus. The answer Is, they stole the virus. But we didn't know that at the time these [investigative] reports came out." See XVI, §2.
Science and Government Report. In the article 'Saint or Scoundrel'? The Gallo Controversy Goes On' (Science and Government Report, 1 February 1994), Dan Greenberg reported various reactions to ORI's withdrawal of charges in light of the Appeals Board rulings. The article by Nicholas Wade was mentioned and quoted, as well as a 'contrary view' contained in a letter to ORI dated 30 December 1993, by Donald P. Francis, who headed the AIDS Laboratory at the Centers for Disease Control in the early days of AIDS research. Don Francis had been scheduled by ORI to testify against Gallo (cf. the "Offer of Proof,' excerpt from page 97 in Appendix 3). Dan Greenberg quoted from the letter of Don Francis as follows:
From the letter of Dan Francis to ORI, dated 30 December 1993. '... the case is a sore in the history of science which will not disappear. The fact that NIH may not want to proceed is an internal NIH issue.... But I fear the sore will continue to fester and will not go away.... The facts of the Gallo case are clear. Unbiased scientists in the field know what happened. I, because of my position as head of the CDC's AIDS Laboratory, saw it up close. In my opinion, Dr. Gallo's behavior was disgraceful, an insult to the integrity of a scientists. Dr. Gallo purposely tried to rob the credit for the discovery of HIV- I from the Institut Pasteur. It was not passive or an oversight.... The stories of Dr. Gallo's unprofessional behavior go on and on. It is indeed sad. He has contributed and could contribute to science. But when his ethics are so blatantly compromised, how can we believe any of his reports? If NIH refuses to confront these issues, how can we expect junior scientists not to emulate the Bob Gallo's of the world?'
pg 491
§4. "The Aftermath of the Gallo Case"
"The Aftermath of the Gallo Case" was the headline of a 7 January 1994 Science article by Christopher Anderson, already mentioned in §2. 1 view this article as important in the way it illustrates problems in journalism (not just scientific journalism), and how the article pushed one point of view at the expense of others, thus leading readers in one direction rather than others. Considering the importance that Science has in the scientific community, I shall devote a separate section to a detailed analysis of this article.
I have severe criticisms of this article on several counts. I shall deal only with a few.
1. The title. My first criticism concerns the title, which was inappropriate, because the Gallo case was by no means over. For instance, the investigation by the HHS Inspector General, and Dingell's investigation, were still going on.
Independently of the fact that the Gallo case was not over, the title set the article specifically in the context of the Gallo case. Furthermore, the entire article emphasized the legalistic context at the expense of other contexts for ORI's performance. The subtitle was: 'An appeals board trounced the federal misconduct office in two recent cases and said it had misinterpreted its own definition of misconduct; in future, the office will be more selective in the cases it takes on.' The article gave weight to so-called 'legal standards' without mention of scientific standards, as in the sentence: "Most experts [sic] agree that ... in essence, [ORI] has for years been misconstruing its own rules.' In light of certain historical facts which I shall recall, I object to an article which sets 'the aftermath of the Gallo case' exclusively in such a legalistic context, and I ask the scientific community to evaluate Science's responsibility in having pushed the legalistic point of view in such an exclusive way.
2. "Misconduct experts" [sic ]. In 'The Aftermath of the Gallo Case,' Science made repeated mention of 'experts." Near the beginning of the article, we find (p. 20): "'If I were just an observer, I'd think the scientific misconduct process is in great disarray,' says Patricia Woolf, a misconduct expert [sic] at Princeton University, who has been an advisor to ORI. In an effort to reduce the confusion, Science asked scientific misconduct experts [sic]--
pg 492
scientists, university administrators, and lawyers--to assess the impact of the four cases and their likely effects on future cases." The point of view of the article is then clearly stated: 'Their almost universal conclusion: To make a charge of scientific misconduct stick, ORI will have to meet higher standards of proof than it has applied in the past.... Most experts [sic] also agree that ORI should have been applying the standard all along, that in essence it has for years been misconstruing its own rules.' In the next column, we read (p. 20): 'The bottom line, according to the experts [sic] Science consulted, is the emergence of a distinct, two-tiered system for handling misconduct.' I have already mentioned the reference (p. 22) to 'Rebecca Dresser, a misconduct expert [sic] at the Case Western Reserve University Law School.'
This repeated use of the word 'expert provided a backdrop of authority for the Science article. How legitimate was this backdrop?
Sciences selection of certain so-called "experts' directed certain conclusions in certain directions. Another selection of scientists would have provided other directions.
(a) Goodstein. Among the so-called expert 'scientists, university administrators, and lawyers" contacted by Science were Paul Friedman, Dean for Academic Affairs at the University of California, San Diego, and a member of ORI's recently disbanded Advisory Board; and David Goodstein, Vice Provost at Caltech. Anderson included quotes from both of them as follows:
'If [ORI] would only have had the sense to go after the clear cases and leave the crap alone, they wouldn't have had these problems.' [Friedman] says. Adds Caltech Vice Provost David Goldstein [sic], The panel did exactly what should be done by holding a high standard. High legal standards chill investigative zealotry."
I had a high opinion of Goodstein, based on some previous acquaintances with some things he was doing, so I was surprised by that quote. I wrote him a letter dated 1 February 1994 to check with him directly whether he was correctly quoted, and whether his opinion was based on correct information. He replied on 9 February that the Science reporter did 'misquote" him, and explained his position more accurately.6 In particular, Goodstein
Footnotes for page 492
6 I circulated Goodstein's reply of 9 February to a number of people, including Science news editor Ellis Rubinstein, to whom I wrote (24 February 1994):
Footnotes for page 492- Continued
"Under the circumstances, I think it is necessary that a correction be made in Science. Otherwise the record would stand concerning a specific way that Goodstein criticized the HHS investigations, and that record is incorrect.'
Goodstein subsequently wrote me (25 April 1994): 'My letter to you, dated February 9th, was a personal one with no cc list. Your act of sending my letter to Science, without my permission and without consultation, and demanding on my behalf a retraction from them was, in my view, a violation of trust sufficiently grave that I am no longer willing to correspond with you."
Thus Goodstein raised serious points, typical in file making, and deserving an answer. I replied on 4 May 1994 addressing myself to these points.
Personal letters. First, Goodstein's letters to me of 9 February and 25 April were on official Vice Provost stationery. I do not regard use of Vice Provost stationery, answering publicly raised questions about the legitimacy of an official quote in Science, as "personal.' Indeed, on 9 February, Goodstein was answering my letter of 1 February, which itself was in the context of an open 'file," with cc lists to all my letters, including my letter to him.
Considering the fact that Science used his name and position to reinforce a tendentious point of view in their article, going to their subscription list of 150,000 and readership of I million, I did not accept to hold a discussion about this public use of the Caltech Vice Provost in the context of what he calls a "personal' letter. I hold officials, especially those quoted as 'misconduct experts,' publicly responsible for the views they express in an official capacity.
Request for a correction. Second, I answered that I had not written on his behalf but on my behalf, as quoted above, that is 'I [sic] think it is necessary that a correction be made in Science.' By withholding from my cc list the information that Goodstein gave a 'rambling explanation,' his insistence that he knew nothing about the Gallo case, and the more accurate description of his position that he wrote me, I would become an accessory after the fact to the misrepresentations in Science.
Journalistic responsibility. Furthermore, Science held an interview with Goodstein. They selected quotes from a "rambling explanation," and printed the quotes in an issue of Science with a subscription list of 150,000 and a readership of I million. Science did not ask Goodstein's permission to print their selection. At best they had notes from the reporter, not even over Goodstein's signature. Colin Norman wrote to Goodstein that Science stood by these notes (letter dated 7 March 1994).
On the other hand, my letter to Goodstein of 1 February constituted a much more careful interview, in which I put four questions to Goodstein concerning the way he was quoted in Science, and the issues raised by The Aftermath of the Gallo Case." My letter to him was in the context of a public challenge to this article. I did my homework, by not accepting at face value what Science attributed to Goodstein, as Vice Provost. I checked with the original source. He had my questions in writing. I did not rely on notes for his reply. I relied on his full letter over his signature on official Vice Provost stationery. I claim that my journalism was responsible in a way that Sciences journalism was not, and I don't understand Goodstein's characterizing my journalism as a 'violation of trust.'
Corresponding with me. Goodstein wrote me that he was 'no longer willing to correspond" with me, and that I 'should not expect to hear' from him again. Of course, it is his prerogative to hold interviews with Science but not with me, and he has no responsibility to communicate with me again. However, he has the public responsibility not only vis-à-vis readers of Science but on the record, for the quotes Science attributed to him, modulo the 'corrections and clarifications" published subsequently by Science, see below.
It remains for readers to evaluate the way Science, Goodstein, and I exercised our respective responsibilities, especially our journalistic responsibilities.
wrote me about the phone interview with Christopher Anderson: "When he asked for my reaction to what had happened, I told him I had not been following the Gallo case, knew nothing about it, and had nothing to say about it.... Before, during and after this discussion [with Science reporter Christopher Anderson], I insisted I knew nothing about the Gallo case.' Goodstein also wrote me: 'Surely Anderson was trying to compress my rambling explanation into one sentence. You can judge for yourself whether he did it accurately. He certainly had no right to put it in quotation marks, or imply that it was meant to refer to the Gallo case.' Anderson did not represent Goodstein accurately. To pass off an uninformed 'rambling explanation' in the sliver of a quote reproduced above is not my idea of a proper representation of Goodstein's position, and constitutes a distortion of Goodstein's uninformed rambling explanation. Furthermore, adding a sliver of a quote next to Friedman's 'crap' gave Goodstein's uninformed rambling explanation a flavor which was Sciences choice. Was it Goodstein's choice?
Science subsequently printed an item labeled "corrections and clarifications.7 In light of Goodstein's letter to me, I conclude that this item perpetuated misrepresentations.
Footnotes for page 494
7 [I reproduce in full one of the two items which appeared in Science, 22 April 1994, following the letters to the editor, page 492, under the heading Corrections and Clarifications.]
In Christopher Anderson's News & Comments article 'The aftermath of the Gallo case" (7 Jan., p. 20) the name of David Goodstein, Caltech vice provost, was spelled incorrectly. Brackets were also inadvertently omitted around three words in his statement about the impact on scientific misconduct investigations or recent rulings by a federal appeals board. The quotation should have read, "The panel did exactly what should be done by holding a high standard. [High legal standards] chill investigative zealotry.' Goodstein was commenting generally on misconduct investigations, not on the Gallo case.
For instance, Goodstein was quoted as one of several 'misconduct experts" [sic]. Informing readers that Goodstein knew nothing about the Gallo case (let alone quoting him to this effect) might have made readers question whether Goodstein rated as an "expert" or not, especially insofar as he referred to the 'panel' (Appeals Board). However, Science still withheld from its readers the fact, 'insisted" upon by Goodstein, that he knew nothing about the Gallo case, and thus still used Goodstein's quote (whether or not questioned per se) illegitimately. Therefore, I regard the way Science handled Goodstein's uninformed rambling remarks, by compressing them into a sharp 'expert" statement without any indication that these remarks were rambling or uninformed, to be manipulative, of Goodstein, of the reader, and of the facts.
Despite the added comment that "Goodstein was commenting generally on misconduct investigations, not on the Gallo case,' the Goodstein quote stood as saying: 'The panel did exactly what should be done by holding a high standard. [High legal standards] chill investigative zealotry." At this point, I shall not reproduce the longer explanations which Goodstein wrote me on 9 February. Absent any further statement from Goodstein, he is responsible on the record in Science for comments supporting 'the panel,' I.e., the HHS Appeals Board, at the expense of ORI. The combination of quotes from Friedman and Goodstein reinforced the overall point of view of the Science article, which was to support a legalistic point of view, and to discredit the efforts (however clumsy and partly incompetent) of ORI, and the Richards Panel, to get at the truth.8
(b) Selectivity of the "experts." The "expert' scientists contacted by Science did not include scientists who, in various ways, had reservations about the Appeals Board decision. I list some such scientists.
- Fred Richards explicitly expressed a point of view shortly after the Appeals Board ruling on Popovic: "For the kind of things we're dealing with in Gallo, the lawyers have no business being here at all.
Footnotes for page 495
8 I find it appropriate here to recall the statement on Scientific Conduct issued by the Councils of the National Academy and Institute of Medicine, and the Executive Committee of the National Academy of Engineering, 2 February 1994, containing the sentence: 'As members of the Professional research community, we should strive to develop and uphold standards that are broader than those addressed by the government regulatory and legal framework for dealing with misconduct in science.'[Underlining in the original]
pg 496
They're not going to contribute anything except exacerbation. The scientific community is perfectly capable of handling these things itself. We have done so for years.' ('U.S. may not fight appeal by Gallo," Chicago Tribune, 10 November 1993, p. 1.)
- Priscilla Schaffer, a professor at the Harvard Medical School, was quoted in the Chicago Tribune immediately following Fred Richards: 'Many of the conclusions that this board of non-scientists reached were really unscientific.' According to the Chicago Tribune, Priscilla Schaffer 'testified for the government against Popovic and was scheduled to testify against Gallo.'
- Donald P. Francis was quoted as mentioned above in Science and Government Report (1 February 1994).
- John Edsall (I know also of three others) wrote to Dingell: "I believe that the standards of ethical conduct for scientists are, and should be, more demanding than the purely legal ones.' Edsall concluded his letter to Dingell by observing that "the attempt to clear Dr. Gallo of all legal charges against him is on the verge of complete success. If you have strong evidence that could lead to a different conclusion, would not this be the time to make it public, in the interest of truth and honesty, and perhaps also of appropriate legal action?" (Quoted in Science and Government Report, 15 March 1994, "With Gallo Exoneration Looming, Dingell Asked to Act,' p. 3.)
No scientist's point of view remotely related to any of these was mentioned in the Science article 'The Aftermath of the Gallo Case' (or the subsequent ScienceScope article, see below). The three pages of "The Aftermath of the Gallo Case' in Science were devoted to placing the Gallo case in the context of "American legal standards,' as a Science editor Colin Norman wrote to Goodstein in a letter dated 7 March 1994. The legalistic context deemed worthy of three pages by Science completely left out a point of view of some scientists that a legalistic approach to cases such as those of Gallo (and Baltimore previously) is undesirable, or whatever expressions various scientists would use. Each one has their own way of formulating their point of view. In particular, Paul Doty, who went public in the context of the Baltimore case, warned that science "risks sliding down toward the standards of some other professions where the validity of action is decided by whether one can get away with it. For science to drift toward such a course would be fatal...' (Nature, 18 July 199 1, p. 183). The Science article "The Aftermath of the Gallo Case' provides documentation of such a slide, not just the 'risk" of such a slide. Paul Doty was not one of the "misconduct experts" mentioned by Science. The bottom line is that the 3-pages long Science article 'The Aftermath of the Gallo Case'
pg 497
pushed the point of view of legal standards at the expense of other standards, e.g., scientific standards.
Also not mentioned were Suzanne Hadley, nor anyone on Dingell's staff, nor anyone from the HHS Inspector General's office, let alone mentioned as "experts." However:
- Suzanne Hadley is an extraordinarily well-informed person, because she originally directed the Gallo investigation until she was "reined in"-_i.e., forced out-by Bernadine Healy. Then until 15 April 1994, she was on detail from HHS to advise the Dingell Subcommittee on Oversight and Investigation about the facts of the case and about documentation which could be available in the files of NIH. By placing 'The Aftermath of the Gallo Case" in the context of American legal standards," at the expense of a context whereby Science would recall the history of the Gallo case, including the "reining in" of Suzanne Hadley by NIH Director Healy (Science, 26 July 1992, p. 372) represented a definite choice of one point of view over another.
- Dingell's opening statement at the hearings of 21 July 1993 brought up the possibility that HHS officials "suppressed evidence" for the patent application of the HIV blood test, and that his investigation encountered "repeated instances of obfuscation and obstructionism on the part of past and current Government officials.... Documents have been destroyed. Documents have been withheld for protracted periods. In several instances, key documents known to exist have never been produced from the official files...."
- The HHS Inspector General was still to be heard from, and we she deal with the Inspector General later.
I object to Sciences selectivity of 'experts," which resulted in leaving out of Sciences article important material and informed points of view which could have been provided by scientists such as those mentioned above, as well as by Suzanne Hadley, Dingell, or the HHS Inspector General.
3. No historical context of the Richards Panel. Nowhere in "The Aftermath of the Gallo Case" (and a subsequent ScienceScope piece) did Science recall the origins of the Richards Panel, namely the solicitation in 1990 by HHS and NIH to the NAS "to nominate a slate of qualified observers to verify the independence and thoroughness of the NIH's own investigation," as reported by Barbara Culliton in Science, 23 February 1990. Culliton wrote further, "We decided to go the 'extra mile' for the NIH's sake and for Dr. Gallo's". Raub told Science " . . . .Press and Thier [President of the NAS Institute of Medicine]
pg 498
have agreed to propose such a panel with the stipulation that Mason confine his selection to that list and agree not to add anyone recommended by the government, which can be said to have a stake in the outcome because It is a signatory to the U.S.-French agreement...." Thus the commitment of HHS-NIH to the NAS was not legalistic but scientific, directed toward "independence and thoroughness," not toward a dependency on "American legal standards."
Did Science contact members of the Richards panel for the article? If Science did not, It was a serious omission. If Science did contact members of the Richards Panel, and they refused to issue a statement, this fact deserved to be reported in light of previous commitments by the Richards Panel to "speak out loud and clear," as reported by Science itself when Barbara Culliton wrote: "Sources say committee members have promised not to discuss their deliberations until they are complete. At that point, they expect to ‘speak out loud and clear’." ("Inside the Gallo probe—The Committees," Science 22 June 1990).
I also recall here that Gallo himself was quoted in the Culliton Science 23 February 1990 article, as supporting "the decision to name outside advisers." "I welcome this," he told Science. "These allegations have been going on too long. I have done nothing wrong and I have no apprehension or anxiety about the review. And, I’m confident that the only chance I have is the help of independent colleagues." These colleagues came to the conclusion that there was "a pattern of behavior on Dr. Gab’s part that repeatedly misrepresents, suppresses, and distorts data and their Interpretation in such a way as to enhance Dr. Gallo's claim to priority and primacy.... Given the quality of the Information derived from propagation of the French virus, we believe that this constitutes intellectual recklessness of a high degree-in essence, intellectual appropriation of the French viral Isolate."
Thus Gallo's "only chance" ultimately was not "the help of independent colleagues" but lawyers and what some people call "legal standards."
However, in its "Aftermath of the Gallo Case" and the subsequent ScienceScope article, Science did not place current events and the rebuff of ORI (and subsequently of the HHS Inspector General) by the legal system In the historical context recalled above. Science did not deal with the significance of the complete breakdown of the commitments made in 1990 by NIH-HHS, as well as the commitment by the Richards Panel "to speak out loud and clear." Such a breakdown of commitments Is certainly part of the Gallo case, and will be part of Its aftermath, but Science chose
to report matters In an entirely different context, favorable to the legal system and insulting to ORI ("leave the crap alone," " [High legal standards] chill investigative zealotry").
Therefore I call Sciences journalism tendentious, and I object.
4. Limited hangout in the "Corrections and Clarifications." From January to April 1994, I communicated my objections described In this section concerning "The Aftermath of the Gallo Case" to Science news editor Ellis Rubinstein. In light of these objections, I regard the "corrections and clarifications" (reproduced in footnote 6) as a limited hangout. For example, Ellis Rubinstein had written to me (letter dated 19 January 1994): "Nevertheless I think you have a point about our headline over our 7 January story: it probably implies more than it should. For that, you should not blame Chris [Anderson] but his editors. While some institutions choose never to concede error of any sort, the Science staff attempts to hold itself to a higher standard." No mention of the defective title was made in the "correction and clarification." Even more importantly, the correction or clarification did not address the deeper objections transcending specific misrepresentations of Goodstein, namely that the whole context of "misconduct experts" was illegitimate and was used to push certain points of view at the expense of others.
Ellis Rubinstein also wrote me on 6 April 1994: "I have admitted failings on our part—not of course sufficiently to satisfy you—and upon occasion have left open the possibility that we erred more than we realize." There is no indication of any further errors In the "corrections and clarifications" printed In the Science issue of 22 April 1994, and Rubinstein did not answer my request for a list of items about which Science "erred more than" he and other editors realize. As far as readers are concerned, the only corrections or clarifications are those made In Science, 22 April 1994, and therefore the above sentence by Ellis Rubinstein is mere verbiage.
5. Previous misreporting by Science; no mention of the ORI Offer of Proof. "Corrections and Clarifications" were needed not only about misquoting Goodstein, but also about the most recent events In the Gallo case. I shall just give one further example here, also having to do with previous misreporting of so-called "facts" by Science concerning Gallo. Such misreporting is indeed part of the Gab case and its "aftermath," if and when an aftermath ever occurs. For example, in 1985, Science reported Gallo’s response to the allegation that the retrovirus given to Gallo’s
group by the Institut Pasteur was used in contravention of the terms of the agreement with the Institut Pasteur. Colin Norman wrote (Science, 8 November 1985): "Gallo indignantly disputes the allegation on several counts, including the fact [sic] that the viruses are not identical and that the amount of virus Montagnier sent would not have been sufficient to infect a cell line (see box on page 643)." On the other hand, sequencing analyses subsequently showed that the French virus LAV was the same as other viruses used by Gallo for the blood test, and in the Offer of Proof by ORI (see Appendix 3), we read:
From the ORI Offer of Proof. p. 77. The evidence will clearly demonstrate that Dr. Popovic had transmitted LAV into a permanent cell line. Dr. Popovic admitted this fact to OSI when he also indicated that LAV grew very well. Exhibit H-319 .... Dr. Gallo was informed that LAV was grown in a permanent cell line.
p. 79. The evidence will clearly reveal that the LTCB had grown the LAV virus in a permanent cell line prior to January 1984.64 Additionally, Dr. Gallo clearly knew of this growth prior to publication of the Science papers in May 1984. Exhibit H-66. It is equally clear that the LTCB was refusing to share that information See e.g. Exhibit H-60 .... Prior to publication of the at-issue Science paper, Dr. Gallo acknowledged that he was aware the Pasteur scientists had LAV in a cell line. See Gallo press conference of April 23, 1984, at 31 ....
What is the responsibility of a magazine, let alone the #1 scientific magazine, to print a correction after reporting as "fact" something which turns out to be false? I wrote to Ellis Rubinstein on 30 March 1994 that it would have been appropriate for Science to follow up the above-mentioned article by Colin Norman, by publishing a correction to the past illegitimate use of the word "fact." I also asked him, in case such a correction had already been published, to bring the correction to my attention. I had no answer from Ellis Rubinstein to this request.
Thus in addition to the selectivity already described, "The Aftermath of the Gallo Case" left out of consideration the substance of the Gallo case, as well as the documentation accumulated in the ORI Offer of Proof. In that article, Science emphasized legalistic aspects in such a way as to discredit ORI, but Science did not even mention the ORI Offer of Proof with its meticulous layout of evidence. There is no indication that any of Science's so-called
pg 501
"misconduct experts" brought it up either. And Science did not take this opportunity to issue "corrections and clarifications" for passing off a falsehood as a "fact."
We touch here on fundamental journalistic responsibilities. Unfortunately, it takes much more space to document the tendentious character of Science's reporting than it took for this reporting to occur in the first place.
§5. The Richards Panel vis-à-vis the Appeals Board
The Richards Panel was systematically rejected by the Appeals Board. In the first place, of course, no member of this panel was on the Appeals Board.
Some scientists testified at the Popovic hearings. According to Science ("Popovic Is Cleared on All Charges; Gallo Case in Doubt," 12 November 1993, p. 982), "the board also rejected much of the testimony from ORI's expert witnesses, including Yale's biochemist Frederic Richards, who headed a committee assembled in 1990 by the National Academy of Sciences to advise federal investigators." In Appendix 2, I shall quote an entire paragraph from ORI's evaluation of Fred Richards testimony. The Appeals Board gave "little weight" to his testimony because "his opinions were developed based on selected information given him by ORI," and "he did not have a background in cell biology, virology, or retrovirology." Concerning the "not done" annotation in the Popovic et al. paper, the Appeals Board found "that he [Richards] could not reliably comment on whether 'not done' had a particular meaning in these disciplines." The above-mentioned Science article quoted Fred Richards as countering: "Not done means not done and anybody who thinks otherwise is crazy."
The rejection of Richards' testimony was in line with two rulings of the Appeals Board, reproduced in Appendix I. One of them required that "for testimonial evidence, ORI must offer proof that its witnesses are competent to testify as to the standards of conduct in the scientific community of which Respondent was a part in 1983-1984..."; the other is that, "if ORI relies on two or more ... findings as cumulatively establishing that Dr. Gallo engaged in misconduct while not alleging that each alleged instance of conduct was alone scientific misconduct, ORI must also offer proof that there was in the scientific community in 1983 and 1984 a standard that permitted unrelated instances of conduct which did not amount to scientific misconduct to cumulatively constitute scientific misconduct .... "
pg 502
Such a ruling went directly against the criticism of the OSI Report made by the Richards Panel, that the OSI Report failed "to integrate the findings into a larger context, namely a pattern of behavior on Dr. Gallo's part that repeatedly misrepresents, suppresses and distorts data and their interpretation in such a way as to enhance Dr. Gallo's claim to priority and primacy."
Fred Richards subsequently stated that he was "absolutely shocked by the attitude of the Board" (Chicago Tribune, 5 November 1993, p. 18).
In the news articles which I have mentioned above, I did not see any statements from members of the Richards Panel commenting on the dropping of charges against Gallo. I find it appalling that the scientific establishment could remain silent after the handling of the Richards Panel (and other scientists) by NIH and HHS, ranging over: - the original pretenses under which it was nominated;
- the resistance to its recommendation for an investigation;
- the abuse and manipulation of this panel by NIH Director Bernadine Healy;
- the withholding of information from this panel by NIH; and
- the ultimate explicit rejection of this panel by HHS.
The entire history of the NAS-nominated Richards Panel represents failures of responsibility and evasions of responsibility across the board: - by NIH and HHS for having solicited the NAS to nominate a panel of scientists
to give credibility to their investigations, and then for having systematically put
down, manipulated, and rejected this panel;
- by the panel itself for having accepted to work under the conditions imposed
progressively by NIH and HHS; and
- by the scientific leadership of the country, especially the NAS, for having washed
its hands of the whole matter.
Given the history of the Richards Panel, how can scientists accept in good faith invitations to consult for NIH and HHS? How can the public expect the scientific community to police itself?. How can scientists, or the public, trust NIH and HHS investigations, after the chaos, incompetence, contradictions, breach of commitments, evasions, suppression of information, and manipulations by the top officials of NIH and HHS which have been documented?
pg 503
The only valid answer I see today is that they can't.
I also ask whether the scientific community is willing to adapt its standards of behavior to the point where if something is legal, then it's OK? To what extent does the scientific community accept a defense of a scientist's actions by appealing to legal criteria, especially when some of us insist that science and scientists must be judged by our own standards and all of us want science to be self-policing?
Excerpts from the conditions set forth by the Appeals Board
Certified Mail sent to Gallo's lawyer, Joseph Onek,
and to the Office of the General Counsel, ORI 6 July 1993
Respondent, Dr. Gallo, sought a ruling to dismiss these proceedings .... If ORI's offer of proof does not meet the requirements set out below, we will grant Respondent's motion to dismiss in whole or in part based on a determination that no reasonable basis exists for proceedings to adjudicate part or all of ORI's proposed findings ....
7. The key issue here, however, is whether Respondent reasonably could have anticipated at the time of this alleged conduct that such conduct, if proved, would constitute "scientific misconduct." If ORI cannot prove that Respondent could have reasonably anticipated that his conduct was "scientific misconduct," then its case is legally insufficient, for the following reasons:
- Even assuming Respondent engaged in the alleged conduct, this fact alone would not impugn Respondent's research integrity.
- If his integrity is not impugned by the conduct, no administrative action to protect the federal government interest is needed or appropriate.
- Applying the label to Respondent in such circumstances would be fundamentally unfair.
12. In the absence of any specific definition of scientific misconduct in a statute or regulation in effect at the time of the conduct, ORI must prove that the nature of Respondent's violation of applicable standards of conduct was such that any reasonable researcher in his position would have considered it scientific misconduct at the time. ...
pg 504
14. We conclude that ORI misread the definition [of "misconduct in science"] in Section 50.102, which we have concluded sets a limit on the scope of this proceeding, for the following reasons:
- To the extent ORI implies in its arguments that any false statement may be a basis for a finding of scientific misconduct, ORI's arguments are inconsistent with the definition at section 50.102.
- The definition (1) uses the word "falsification" (which implies more that simple falsity); (2) refers to "other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting scientific research;" and (3) specifically excludes "honest error or honest differences in interpretations or judgments of data."
- This definition cannot reasonably be read as encompassing falsification or any other conduct which does not seriously deviate from commonly accepted practices within the scientific community or which results from honest error or honest differences in interpretation of judgments of data.
- Since ORI has the burden of proving scientific misconduct by a preponderance of the evidence, ORI must therefore, prove here that the alleged misconduct did not result from honest error or honest differences in interpretations or judgments.
15 .... If we do not receive such an offer of proof with respect to each allegation, we would dismiss this proceeding with regard to that allegation. To do otherwise would result in this Department committing its resources for a proceeding which could not lead to a legally supportable result in ORI's favor ....
WHAT IS REQUIRED FOR ORI'S OFFER OF PROOF
For each of the four findings of censurable conduct [referred to as A1 through A4 in the order stated on pages 52 and 54 of the ORI Report], and for the finding for Allegation 8, ORI must make a separate offer of proof....
For each finding ORI must address each element listed in bold below.
... For A1--ORI must offer proof that the changes proposed by Dr. Gallo were gratuitous and self-serving ....
...For Allegation 8---ORI must offer proof that the statement in question falsely reported the status of LAV research.
...For A3--ORI must offer proof that there was a standard of conduct in 1983 and 1984 for laboratory chiefs at NIH requiring them to supervise record keeping by senior scientists and their technicians ....
pg 505
...For A4---ORI must offer proof that there was a standard of conduct in 1983 and 1984 which required Dr. Gallo, under the particular circumstances, to take actions which he did not take to determine the source of H9 and that there was a standard of conduct at that time concerning access by other researchers to a cell line such as H9.
- If intent is necessary to render the deviation from the standard serious or otherwise to render the conduct scientific misconduct, Respondent had that intent.
For testimonial evidence, ORI must offer proof that its witnesses are competent to testify as to the standards of conduct in the scientific community of which Respondent was a part in 1983-1984 applying to someone in Respondent's job position at NIH at the time. For documentary evidence, ORI must produce that document or cite to it by proposed exhibit number.
Moreover, for each finding A1 through A4, ORI must state whether that finding alone is a funding of scientific misconduct. IF ORI relies on two or more of the A1 through A4 findings as cumulatively establishing that Dr. Gallo engaged in misconduct while not alleging that each alleged instance of conduct was alone scientific misconduct, ORI must also offer proof that there was in the scientific community in 1983 and 1984 a standard that permitted unrelated instances of conduct which did not amount to scientific misconduct to cumulatively constitute scientific misconduct which impugned the integrity of a researcher ....
ORI's offer of proof must be submitted within 14 days of the receipt of this letter. Although we gave ORI an opportunity to clarify its offer of proof in Board Docket No. A-93-100, we do not intend to provide such an opportunity here.
In accordance with this ruling, these proceedings will be dismissed with regard to any allegation for which ORI does not present the offer of proof described above.
s/Judith A. Ballard
s/Norval D. (John) Settle
s/Cecilia Sparks Ford
President Panel Member
pg 506
Excerpts from the "DECISION" of the Appeals Board
SUBJECT: Mikulas Popovic, M.D.
Docket No. A-93-100, Decision No. 1446
... In spite of the narrow focus of this proceeding, this case has compelled us to parse a record reflecting years of investigations, thousands of pages of documents and lawyers' briefs, a hearing which lasted 12 days, and the time, attention and disagreement of dozens of scientists, investigators, and lawyers--all focused essentially on the meaning which we should give a handful of words and notations contained in one heavily-edited paper written by a scientist with limited English skills during a volatile period of scientific discovery a decade ago. The paper in question, it is undisputed, made a major and lasting contribution to establishing that a retrovirus was the etiological agent of AIDS---even assuming the most ambitious reading of error into the parts in question here.
One might anticipate that from all this evidence, after all the sound and fury, there would be at least a residue of palpable wrongdoing. That is not the case. On reviewing this lengthy record and all the evidence and argument related to each of ORI's allegations, and notwithstanding the vigorous efforts of ORI counsel, we find that ORI was simply unable to prove by a preponderance of the evidence that Dr. Popovic is guilty of scientific misconduct--even under standards first promulgated years after the paper was published ....
We found the following general flaws in the evidence ORI presented:
- Each of the findings of scientific misconduct was based on reading in particular way language which, in context, was merely ambiguous ....
- The opinions given at the hearing by ORI's scientific advisors were based on misunderstandings about what was involved in the research at issue and what Dr. Popovic and others had said. While these advisors were experts with impressive credentials, they were not asked by ORI to conduct a first-hand investigation. Their information was largely derived from the ORI investigators' understandings, which in some instances ignored or misrepresented evidence in the record.
pg 507
Moreover, none of these advisors had direct experience isolating a novel retrovirus. Since their opinions were based on a number of erroneous assumptions, they were largely irrelevant. Testimony by the one retrovirologist who testified for ORI who could be considered a disinterested expert supported Dr. Popovic's case more than ORI's.
- These advisors drew unreasonable inferences from the nonscientific evidence in the case ....
- ORI and its experts also did not have a clear idea of the proper legal and scientific standards to apply to Dr. Popovic's conduct. They faulted him simply for doing things differently from how they would have done things. In evaluating Dr. Popovic's conduct against their own, they also applied their experience in other disciplines in a way that failed to take into account the nature of the experiments reported in the Science paper at issue and the status of AIDS research at the time.
- ORI gave an importance to the matters at issue here which is not justified when the paper is examined as a whole. None of the matters here has any significance to the validity of the major conclusions of the paper ....
[Concerning a disputed sentence in the Popovic et al. paper, the Appeals Board commented on the scientific advisors to ORI as follows, p. 22.]
We found the testimony on this sentence by the scientific advisors who had been involved in ORI's investigation (Drs. Richards, Berns, and Schaffer) to be either irrelevant or unpersuasive--in spite of these experts' impressive credentials, for the following reasons:
- Based on their testimony as a whole, as well as their own descriptions of their role in the investigation, we find that these advisors did not form their opinions independently, after consideration of all the relevant evidence...
- None of these experts appeared to have carefully examined the language and context of the disputed sentence, or to have independently tested it against the record ....
[Concerning an annotation "ND" concerning an experiment which was claimed to have been done, but actually was "Not Done," a question arose as to what the abbreviation "ND" meant. I quote from a passage on page 43 referring to Fred Richards. The letters Tr below refer to the transcript of testimony.]
... For its position that "ND, not done" meant "not performed," ORI relied on testimony from five witnesses (Dr. Richards, Dr. Hadley, Dr. Martin, Dr. Watkins and Dr. Gardner).31 For the following reasons, we find that ORI's reliance on this testimony is misplaced:
- Dr. Richards was one of a group of scientists who advised NIH during the investigation. The advisors did not themselves undertake to investigate and ascertain whether the statements in issue were false. Tr at 513-15. Dr. Richards testified that the advisors had concluded that the ND data points appeared to be falsified because ND is defined in the footnote to the paper as meaning not done, which is a term of art meaning the experiments were not performed. Tr at 438, 514. We give little weight to his testimony for two reasons. First, his opinions were developed based on selected information given to him by ORI. See also Tr at 421, 467-7; 492; 510; 512-13. Second Dr. Richards readily acknowledged that he did not have a background in cell biology, virology, or retrovirology. Tr 15 479-81; 503-04; 56-07. We find, therefore, that he could not reliably comment on whether "not done" had a particular meaning in these disciplines.32 We also note that Dr. Richards stated that there are no generally accepted standard symbols to use when you might have ambiguous results or a problem with a particular experiment. Tr at 520. [I omit footnotes 31 and 32.]
Excerpts from the "Offer of Proof" from ORI to the HHS Appeals Board
In the matter of Robert C. Gallo, M.D.
Board Docket No. A-93-91
[The document is undated, but was sent Federal Express to the Appeals Board and to Gallo's lawyer on 30 August 1993. The document is 99 pages long. This document is available from ORI on request, under the Freedom of Information Act. There is no substitute for the original document, which is meticulous. I have kept the footnote numbers but usually did not reproduce the footnotes themselves. Sometimes they give technical references to testimony, and sometimes they bring up further documentation.]
From pp. 2-6. In its Final Report to the allegations of scientific misconduct against Dr. Robert C. Gallo, the ORI concluded that
pg 509
Dr. Gallo committed scientific misconduct with respect to his following statement published in his article in Science:2
These findings suggest that HTLV-III and LAV may be different. However, it is possible that this is due to insufficient characterization of LAV because the virus has not been transmitted to a permanently growing cell line for true isolation and therefore has been difficult to grow in quantity.
... In its Final Report, ORI also specifically identified four findings of inappropriate conduct by Dr. Gallo which had provided the essential context for its evaluation of the allegations against Dr. Gallo.3 [Footnote reference made here to Crewdson's Chicago Tribune article.] These are summarized below:
Allegation A1.4 In April-May 1983, Dr. Gallo inappropriately inserted changes into a paper written by scientists at the Pasteur Institute (the "Barre-Sinoussi paper").5 The paper had been forwarded to Dr. Gallo for his assistance in having it accepted for publication by Science. Exhibit H-6. In the process of shepherding the paper, and eventually serving as its peer reviewer, Dr. Gallo both authored an Abstract and made significant substantive modifications which advanced his own hypotheses rather than those of the Pasteur scientists .... These representations were not identified as comments by Dr. Gallo but rather added as gratuitous and self-serving changes purportedly representing the views and findings of the French authors.
Allegation A2. Dr. Gallo was Senior Author on the Popovic paper .... Thus the paper was replete with at least 22 incorrect statements concerning LTCB research, at least 11 of which were falsifications amounting to serious deviations from accepted standards for conducting and reporting research ....
Allegation A3. ORI found that Dr. Gallo's failure or refusal to meet his obligations as laboratory Chief created an atmosphere which interfered with, rather than ensured, the accurate and appropriate conduct and reporting of scientific research.
Allegation A4. ORI determined that Dr. Gallo failed to determine the source of [the cell line termed] "H9" in a timely manner and placed inappropriate restrictive conditions on access of other scientists to LTCB reagents.
... ORI determined that the preferable course of reporting its Findings was to announce its finding of scientific misconduct that Dr. Gallo misrepresented the use and significance of LAV in the Popovic paper in light of the inseparable context of its four other findings. Thus in its Final Report, ORI not only explained its finding of scientific misconduct in Dr. Gallo's false reporting of the use and significance of LAV but also explained the context in which that finding was made and should be evaluated, i.e. the pattern of inappropriate conduct and scientific misconduct articulated in Allegations A1 through A4.
... The Board, however, has now ordered ORI to parse its findings to identify which of these areas of censurable conduct, either separately or in the aggregate, constitute scientific misconduct, and for each instance of scientific misconduct, to identify sufficient documentary and testimonial evidence to support a finding of scientific misconduct. In response to this directive, ORI submits this Offer of Proof..
p. 11 Concerning Dr. Gallo's Inappropriate Conduct as Reviewer of the Barre-Sinoussi Paper. Dr. Gallo introduced several improper and self-serving changes in the Barre-Sinoussi paper. ORI will show that Dr. Gallo altered the paper to reflect his own theories about the cause of AIDS. Specifically, ORI will show that Dr. Gallo inappropriately added a sentence: "The virus [LAV] appears to be a member of the human T-cell leukemia virus (HTLV) family." Exhibit H-13 at 868. Similarly, he altered another sentence in the manuscript to read: "We tentatively conclude that this virus, as well as all previous HTLV isolates, belong to a family of T-Lymphotropic retroviruses that are horizontally transmitted in humans .... " Id. Dr. Gallo's insertion of these references to "HTLV," coupled with his definition of HTLV as "Human T-Cell Leukemia Virus," rather than "Human T-cell Lymphotropic Virus," deliberately and erroneously linked LAV and HTLV-I.7 The Pasteur scientists had made no such conclusion or suggested any such link and, in fact no such link exists. Moreover, Dr. Montagnier has denied seeing any reference to HTLV-I in the draft of the paper he saw prior to publication. Exhibits H-207; H-189, Attachment 1 ....
p. 12. Through his changes, Dr. Gallo was able to subvert the article to appear to be a confirmation of his personal misplaced theory that the AIDS virus was linked to his own HTLV-I virus...The evidence will further demonstrate that, when Dr. Gallo forwarded the paper to Science with his comments, he clearly downplayed the significance of the changes by disingenuously representing them to the journal editor as "mainly stylistic and grammatical"....
p. 14. Moreover, the evidence demonstrates that the Abstract was not written in concert with the French authors. Rather, Dr. Gallo gratuitously penned the self-serving Abstract to foster his own aims and accomplishments, even over Dr. Montagnier's and Dr. Chermann's protestations. Exhibit H0189; Testimony of Dr. J.C. Chermann...
p. 15. Dr. Gallo was able to accomplish this by, in part, inappropriately taking total control over review of the paper, serving both as mystery co-author and sole peer reviewer in contravention of accepted peer review policies.10 ORI will show that the fundamental underpinning of the peer review process rests in the objectivity of the reviewer. Unfortunately, Dr. Gallo's actions demonstrate a total absence of objectivity and a conflict of interest, resulting in an undermining of the peer review process.
p. 24. In sum, the testimonial and documentary evidence will demonstrate that Dr. Gallo is responsible as senior author for at least nine separate acts of falsification which were at issue in the Popovic hearing (i.e., two for the "first shown" sentence; four for the "ND" entries in Table 1; one for the "10%" entry in Table 1; and two for the "ND'" entries in Table 2). Dr. Gallo's failure to correct these false statements is a material breach of his obligations as senior author and Laboratory Chief of the LTCB to ensure the accurate and honest reporting of research. See also allegation A3, infra.
p. 25. The finding for this allegation is not derived wholly from the allegations at issue in the Popovic hearing. Thus even if the Board were to find that Dr. Popovic were not guilty of scientific misconduct with respect to the allegations listed above, Dr. Gallo is nevertheless independently responsible for these falsifications because of his position as senior author of the Science paper and his position as the Laboratory Chief of the LTCB ....
In addition to the false statements at issue in the Popovic hearing, the Science paper contains 13 other incorrect and misleading statements ....
a. The Science paper provided no specification of when and how often fresh cells were added to the HT (H4) cultures depicted in Figure 2a and described in the methods section .... [All 13 "incorrect and misleading statements" are dealt with seriatim, from p. 25 to p. 32.]
pp. 36-40. Dr. Gallo had an obligation as a Laboratory Chief to ensure that Dr. Popovic and others in the Lab were instructed to be, and were in fact, meticulous in their scientific efforts and record keeping methods .... Evidence of Dr. Gallo's failure to supervise and manage the activities of Dr. Popovic and the LTCB adequately will include but not be limited to the following: the LTCB's failure to catalogue appropriately the receipt of the July shipment of LAV from the Pasteur Institute l7; the LTCB's failure to record culturing of the July shipment of LAV18; the LTCB's failure to keep adequate contemporaneous records of Dr. Popovic's alleged reinfections of the Ti7.4 and HUT-78 cell lines with LAV in November 198319; the LTCB's failure to record adequately the results of alleged IFA experiments performed before December 1983 on the LAV sample received by the LTCB from Pasteur in September 198320; the Laboratory's failure to record adequately the initiation of the culture later identified by the Lab as MOV21; the Laboratory's failure to record adequately any RT, IFGA, or EM data for the "HT"/"pool" purportedly created and used by the LTCB in isolating and growing the AIDS virus22; the Laboratory's failure to record adequately the repeated infection of the eight HUT-78 clones purportedly infected with the "pooled" virus23; the laboratory's failure to record adequately the infection of the critical samples included in what Dr. Popovic and Dr. Gallo have called a "host range" (February 13, 1984) experiment or to make any record of any experiments other than EMs performed upon the most important of those samples24; the laboratory's failure to record adequately, or even to identify, the two samples labeled "L" that were the first two samples purportedly tested with the rabbit antiserum and found positive for the AIDS virus on February 2 I, 198425; the LTCB's failure to retain any sample of the pooled culture that was purportedly referenced in the Science paper.26
ORI will present witnesses to establish that the very essence of science rests upon adequate record keeping It is incumbent upon scientists to make and keep records sufficient to document each step taken in an experiment in order to allow others to retrace those steps,
to evaluate the research and to reproduce the experiment. These witnesses will testify that, in the absence of such records, a negative inference is drawn by the scientific community. These witnesses will testify that such record keeping is all the more important when a scientist intends to publish his results, especially where those results purport to be ground breaking and the paper is seminal to an area of research. The resources available to the LTCB make these lapses both indefensible and incredible ....
p. 41. ORI will present evidence that Dr. Gallo's emphasis on speed, volume, and priority of LTCB publications required imprecision and pushed his laboratory to cut comers and round results. Evidence of this will be produced through LTCB scientists such as Drs. Edward Korwek and Kalyanaraman and from published examples, including the four Science papers. The testimony of Dr. Popovic will be presented to demonstrate that it was Dr. Gallo's rash to publish that contributed to the numerous falsifications and misrepresentations in the Popovic paper. ORI will demonstrate that Dr. Gallo's obsession has been fueled by his knowledge in March 1984 of comparative competitive serology studies completed by the CDC, the LTCB and the Pasteur as well as by what he learned at the Pasteur in April 1984 .... These events caused him to fear that someone else might be the first to develop and report on the AIDS blood test.29
Footnote 29: Witnesses such as Dr. Donald Francis, Dr. Luc Montagnier, Dr. Malcolm Martin, Dr. James Curran and Dr. Cabradilla will testify about what Dr. Gallo saw at the Pasteur and the serology studies that caused him to accelerate publication of the papers. ORI will demonstrate that it was his fear of losing primacy that caused him to accelerate publication of the papers. Indeed, the evidence will demonstrate that as early as February 1984 the authors had decided to have the papers ready for publication by late April. However, ORI will show that Dr. Gallo's review of the serology results on March 12, 1984 triggered his decision to accelerate publication, Id.; See also Exhibit H-219.
p. 46. ORI Witnesses. ORI will present the following witnesses to establish the duties of a Lab Chief at NIH and elsewhere and how Dr. Gallo's conduct seriously deviated from the commonly accepted practice in the scientific community and NIH in 1983-1984: Dr. Richard Adamson; Dr. Edward Brandt; Dr. Walter Dowdle; Dr. Alfred Gilman; Dr. Robert Goldberger; Dr. Suzanne Hadley; Dr. Arthur Levine; Dr. Malcolm A. Martin; Dr. James G.
pg 514
Mason; Dr. J. Michael McGinnis; Dr. Howard E. Morgan; Dr. Mary Jane Osborn; Dr. Joseph E. Rail; Dr. William H. Raub; Dr. Frederic Richards; Dr. Joseph Sambrook; Dr. Priscilla Schaffer; Dr. John Stobo; Dr. Robert R. Wagner.
p. 47. 1. Summary of the Offer of Proof. The evidence will show that Dr. Gallo took a cell line identified by another scientist--"HUT-78"--and used it to successfully, continuously grow the AIDS virus, first LAV, then LAV as "MOV," then the "pool" isolate, "HTLV-IIIb." Dr. Gallo renamed the cell line "HT," and when he published his findings, he misrepresented and obscured the origins of the cell line so that its true identity could not be discerned. Thereafter, for a prolonged period, Dr. Gallo failed to diligently seek out the truth about the origins of "HT." Even faced with important evidence from multiple sources that HT was HUT-78, Gallo failed to acknowledge this fact to the scientific community. Not until 1989 did Dr. Gallo finally admit that the cell fine he used and called "HT" was, in fact, HUT-78. Exhibit H-179 at 254; H0315. Dr. Alan Rabson will testify about the study, published in 1989, that confirmed the identity of H9 and HUT-78 ....
p. 48. 2. Dr. Gallo's Misappropriation and Misrepresentation of the HUT-78 Cell Line.
(a) Factual background. In the Fall of 1983, Dr. Popovic used several cell lines, including a cell line he found at the LTCB, identified as "HUT-78," for his initial attempts to infect a permanent cell line with suspected AIDS virus isolates ....
p. 49. Meanwhile, Dr. Popovic renamed the parental cell line, changing the name from "HUT-78" to "HT." Drs. Popovic and Gallo claimed that the principal reason for the renaming was their uncertainty that the cell line Which they cloned and with which they succeeded in growing the AIDS virus, was authentic HUT-78. Thereafter, in numerous scientific papers, talks, and internal memoranda, Gallo represented "HT/H9" and "H9" to be a new "discovery," a "breakthrough" accomplishment for the LTCB,
The evidence will show that Gallo knew or should have known that HUT-78 and HT were one and the same cell line...In fact, as the evidence will show, Dr. Gallo systematically misrepresented the origins of the HT cell fine so that his fellow-scientists could not discern HT was really HUT-78. Consequently, Gallo's fellow scientists were not aware that HUT-78, a readily available cell line, was permissive for the AIDS virus, and they devoted considerable effort to attempting to obtain Gallo's cell line, upon which he placed onerous conditions for its use. See discussion infra ....
pg 515
p. 53. Significance of Gallo's Deviations from This Standard. Gallo's unattributed use and subsequent obfuscation of the identity and origins of the cell line he used to grow the AIDS virus is significant in at least three respects. First, Dr. Gallo's failure to identify the origin of HT/H9 introduced a wholly unnecessary void in AIDS research, at the time as it is now, a particularly critical area of public health concerns. Second it denied other scientists immediate access to HUT-78, a readily-available cell line, while they delayed progress by securing, or attempting to secure, Gallo's "new" cell line.
Finally, Gallo's obfuscation/misrepresentation of the identity and origin of "his" cell line denied Dr. Adi Gazdar, the scientist principally involved in the discovery of the HUT-78 cell line, rightful recognition for his discovery. See Exhibit 1.
Numerous ORI witnesses will testify that it was a serious deviation from accepted practices for Dr. Gallo not to identify HT/H0 as a derivative of HUT-78, or at least to disclose this possibility, both in the initial Science paper describing HT and H9 and in subsequent communications.35
Footnote 35: Among the witness who will testify regarding the need to identify the origin of a cell line used in experiments and the impropriety of concealing that origin, are Dr. Schaffer, Dr. Curran, Dr. Richards and Dr. Tramont.
p. 57. 3. Dr. Gallo's Restrictive Conditions on Provision of the H9 Cell Line
(a) Factual background. Shortly after publication of the Popovic Science paper, in May 1984, numerous scientists contacted the LTCB, seeking to obtain both Gallo's infected cell line (H9/HTLV-IIIB) and the uninfected cell line (H9). The uninfected cell line was particularly important, because it allegedly was a "new" cell line that was uniquely permissive for growth of the AIDS virus. Gallo's fellow scientists wanted to use the H9 cell line to attempt to grow their own AIDS virus isolates, to produce those isolates in quantity, and to initiate the numerous, varied experiments that were the obvious "next steps" in AIDS research, most of which required the existence of substantial quantities of HIV.
The evidence will show that despite clear standards in the scientific community that reagents should be freely distributed to responsible scientists, Dr. Gallo (1) refused outright to provide the uninfected H9 cell line to some researchers; (2) delayed providing the cell line for substantial periods of time for some scientists, while other scientists were promptly provided the reagents; (3) imposed restrictive conditions on the cell line to virtually all to whom he supplied it,
pg 516
with particularly onerous conditions for scientists not in his favor; and (4) otherwise gave preferential treatment to scientists whom he favored.
p. 58. Favoritism in Distributing the Reagents: The basic transfer agreement for receipt of either the infected or uninfected cell lines, developed at the LTCB, contained five conditions. Most of these were standard conditions related to safety and patent considerations. However, one of the conditions was decidedly non-standard: "Work performed will be on a collaborative basis with Dr. Gallo and his laboratory unless stated otherwise." Particularly favored scientists were not required to sign a transfer form (e.g. D. Zagury); other favored scientists had their transfer form annotated by Gallo himself (e.g., Dr. R. Weiss' form was annotated, "Collaboration at will for Dr. Weiss O.K.R. Gallo').
p. 61. Refusal/Delay in Providing Reagents: Gallo's treatment of certain of his PHS colleagues was particularly outrageous. For example, ORI will present evidence showing that on May 14, 1984, Dr. Malcolm Martin, a laboratory chief at the National Institute on Allergy and Infectious Diseases, NIH, requested the uninfected cell line from Dr. Gallo. Exhibit H-89. Although Dr. Gallo's practice was to review the requests on an almost daily basis, Dr. Gallo did not respond to this request until June 22, 1984. Dr. Gallo refused Dr. Martin's request, stating that it (the uninfected cell line) was "still being characterized." Exhibit H-102. Dr. Gallo also demanded to know what Dr. Martin intended to do with the uninfected cell line; Dr. Gallo explicitly stated that he did not want Dr. Martin to attempt to grow LAV in a cell line. Exhibit H-102.
Dr. Gallo said he would send Dr. Martin the infected cell line, and he sent to Dr. Martin a transfer agreement specifically designed for him. Besides the five conditions in the basic agreement, the agreement sent to Dr. Martin contained two additional, particularly outrageous conditions:
"Work with these reagents will not be published without prior approval by Dr. Gallo'; "Reagents will not be used in comparisons with other viruses."
ORI will show that these restrictions were part of an effort by Dr. Gallo to ensure that Dr. Martin would not be able to advance certain areas of research. Dr. Martin will testify regarding his interactions with Dr. Gallo on this matter. See also Exhibit H-18.
p. 63. Dr. Gallo waited over a month to respond to the CDC's request for uninfected H9. See Exhibit H-92.
pg 517
When Dr. Gallo finally provided materials to CDC--a sister PHS facility--the agreement included seven restrictions .... But Gallo imposed an even more obnoxious condition on CDC, i.e., not only did he tell the CDC scientists what they could not do with the infected cell line; he specified to CDC the only kinds of research it could do: "They (the reagents) will only be used for seropidemiologic studies and blood bank assays."
p. 64. Standards for the Sharing of Research Resources. ORI will prove that it was and is a commonly accepted practice within the scientific community that when a researcher has published research on a specific cell line, it is incumbent on the researcher to make the cell line freely available. These standards are reflected in numerous policies and publications. The National Academy of Sciences (The "Academy") specifically recognizes that "After publication, scientists expect that data and other research materials will be shared upon request .... [S]cientists should not deny requests for primary data because of professional jealousy." The Academy also acknowledged that proprietary interests of the scientist can be protected by the filing of a patent.44 Because Dr. Gallo had already protected whatever financial interests he might have had by filing a patent application, he had no basis for withholding the reagents from other researchers.
In 1989, the Institute of Medicine, Division of Health Sciences Policy, produced a report of a study by a committee on the Responsible Conduct of Research. Exhibit H-270. The panel recognized that "authors of published work have a traditional obligation to aid scientists interested in independent replication [including] ... access to the methods and reagents necessary for reproduction.'...
ORI will present numerous witnesses that will testify that such a standard existed in the scientific community in 1984 and exists now.45 The Richards Panel chastised Dr. Gallo's refusal to distribute uninfected H9 cell lines unless others entered into collaborative agreements:
Against the backdrop of comments from Gallo about the need for speed to counteract the growing AIDS epidemic, we note that the report states that Gallo refused to distribute uninfected H9 cells unless collaborative agreements had been secured from the other investigators ... 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.
pg 518
p. 68. Dr. James Mason, formerly Director of the CDC and former Assistant Secretary for Health, will testify that so egregious was Dr. Gallo's refusal to provide his reagents to CDC scientists who had requested them that he was forced to intercede on behalf of CDC researchers whose requests for the cell line and other reagents had not been honored by Dr. Gallo .... ORI witnesses will testify that Dr. Gallo informed CDC staff that LTCB intended to delay sharing of the reagents until Dr. Gallo felt he had accomplished his own work with the reagents.
p. 69. Dr. Gallo's conduct was so antithetical to the mission of PHS and standards within the scientific community that, at a June 18, 1984 NIH AIDS Executive Committee Meeting, Dr. Wyngaarden specifically ordered Dr. Gallo to provide the uninfected cell line to Dr. Malcolm Martin and Dr. Walter Dowdle. Exhibits H-99, H- 103.
pp. 70-71. Numerous witnesses will testify that Dr. Gallo's prohibition against other researchers who were provided the cell lines and reagents could not conduct comparisons of HTLV-IIIB with LAV was a restriction imposed by Dr. Gallo and not PHS.54 ORI will present testimony that these restrictions were unprecedented and contrary to accepted PHS practices, and contrary to accepted practices for the conduct of research.45
Dr. Gallo's restrictions on providing HIV reagents to the extramural community was noted by many members in the scientific community. Exhibit H-175. For example, the Dean for Academic Affairs for the Harvard School of Public Health noted the agreement "places unacceptable restrictions on research, is inconsistent with long-standing policies of this and many other major research institutions and threatens to inhibit vital research activity on a major threat to public health." Exhibit H-150. In response to this observation, Dr. Fischinger acknowledged that it would be "totally inappropriate" if there were any real strictures to the dissemination of research results in AIDS to other scientists and the public.56 Exhibit H-151.
... In addition to the witnesses identified above, Drs. Goldberger, Rail, Raub, Morgan and McGinnis will testify to the accepted norms of scientific practice for identification of unique cell lines and their availability to the scientific community and Dr. Gallo's deviation therefrom.
p. 72. Concerning Specifically the Statement Published in the Science Article: Dr. Gallo is charged by ORI with falsely reporting
pg 519
that LAV had not been transmitted to a permanent cell line. Exhibit H-233. ORI will demonstrate that this sentence is embedded in a significant passage of the paper that is crafted in such a way as to be patently misleading. ORI will prove that this misrepresentation was material to the findings of the paper and was perpetrated in an attempt to distinguish falsely the LTCB's discoveries and to place the research of the LTCB inappropriately ahead of its perceived competitors ....
p. 80. Thus, ORI will demonstrate that, not only had the LTCB transmitted LAV to a permanent cell line prior to publication of the Science paper, but the LAV virus had also been significantly characterized in several other laboratories, including the Pasteur, CDC, and the LTCB, prior to publication of that paper. Indeed, the Pasteur scientists made a number of scientific presentations (with Dr. Gallo present) and published several papers describing their characterization of LAV. See, e.g., Cold Spring Harbor presentation (Sept. 15, 1983) (paper handed by Dr. Montagnier to Dr. Gallo at this time); thus Dr. Gallo clearly had knowledge of this characterization. Exhibits H-027, 34; New York Academy of Sciences presentation (Nov. 14, 1983) (showing effect of LAV on T-cells and showing "Characteristics" of LAV in table 4); Park City, Utah, presentation by J.C. Chermann (at which Dr. Gallo was moderator) (Feb. 6, 1984) of "Characterization and Possible Role in AIDS of A New Human T-Lymphomatic Retrovirus," Exhibits H-44, 44A ....
p. 81. Similarly, ORI will show that contrary to Dr. Gallo's assertion in the Science paper, LAV had not been difficult to obtain in quantity. Indeed, the record will show that the Pasteur scientists produced the LAV virus in substantial quantifies and supplied the LTCB with ample quantities of LAV upon demand prior to May 1984. See, e.g., Dr. Gallo's OSI submission (May 15, 1990), Att. LAV-6; Testimony of Drs. Chermann, Barre-Sinoussi, Montagnier, Francis and Martin ....
p. 83. Accordingly, ORI will establish that the statements in the Science paper by Dr. Gallo that LAV had been insufficiently characterized, had not been transmitted to a permanent cell line, and had been difficult to obtain in quantity are misleading and false. Indeed, ORI will show that Dr. Gallo knew these statements were misleading and false when he inserted them into the paper. Therefore, his actions constitute scientific misconduct ....
p. 86. The drafts of the Popovic paper are highly instructive with respect to the nature and intent of Dr. Gallo's actions in writing the disputed paragraph.
pg 520
Exhibits H-48-56, H-72. All available drafts, including those drafts that Dr. Popovic retrieved from his sister in Austria, will be submitted as evidence. The various drafts of the Popovic paper will be introduced to reflect the evolution of the controversial statement. The drafts reveal a steady diminution in the attribution afforded the Pasteur and the role of LAV in the LTCB's AIDS research. The successive drafts reveal Dr. Gallo's apparent increasing determination to exclude references to LAV, a determination that eventually culminated in the false and misleading statement regarding LAV selected by Dr. Gallo for the final version of the paper.
p. 87 .... Draft 2 states in relevant part: "... LAV as a reference virus (gift from Dr. L. Montagnier) has been used in the first series of experiments. Two cell lines with characteristics of mature T-cells showed a susceptibility to the virus infection as determined by reverse transcriptase (RT) assay...The infected parental cell line exhibited positivity for particulate reverse transcriptase activity in culture fluids .... "
... Draft 4 reflects substantial changes by Dr. Gallo. Significantly, Dr. Gallo struck through the reference statement above acknowledging the use of LAV in Dr. Popovic's cell fine experiments. Dr. Gallo's handwritten note beside the deletion of the references to LAV states: "Mika, you are crazy."... Similarly, Dr. Gallo deleted a statement by Dr. Popovic that LAV "... is described here as HTLV-III."
p. 88. Additionally, Dr. Gallo fundamentally altered the description of Dr. Popovic's initial LAV experiments. These first experiments were actually conducted using two cell lines (Ti7.4 and HUT78). However, Dr. Gallo changed the description to a single cell line. In order to obscure the cell fines further, Dr. Gallo altered the identifying information on this cell line from a patient with Sezary Syndrome, an identifier that would likely clue the reader that the "new" cell line was actually HUT78, to a patient with ATL.
p. 90. In Draft 8, the references to LA's being a gift from Drs. Montagnier and Chermann of the Pasteur as well as the acknowledgment that LAV was grown in I-IT and has similar cytopathic effects are deleted. The sentence referring to LAV's characterization is modified to read, "however, it is possible that this is due to insufficient characterization because of poor virus production." Furthermore, the final sentence is truncated to eliminate the clause "and for the resolution of HTLV-III and LAV."
pg 521
p. 91. ORI will prove that the progression of changes Dr. Gallo made to the Popovic paper demonstrates a continuation of his efforts to obscure the use and significance of LAV in the LTCB's research .... Dr. Gallo's efforts to obfuscate the truth will be further demonstrated by a review of Dr. Gallo's varying explanations for the false statements, explanations he apparently jettisoned by settling upon the explanation du jour that he was referencing the French peer reviewed published literature. 76...
p. 97. ORI WITNESSES
Drs. Goldberger, Rail, Morgan, Raub, Huth, Richards (and other members of the Richards Panel), Schaffer, and Woolf will testify regarding the acceptable standards in the community and NIH, what constitutes a serious deviation from those standards and why Dr. Gallo's conduct amounts to scientific misconduct.
Drs. Martin, Cabradilla, Francis, McGrath, Chermann, Montagnier, Barre-Sinoussi, Schaffer, and Hadley will testify about the growth of LAV in the Pasteur and the LTCB and Dr. Gallo's awareness of the growth of LAV in the laboratory.
Drs. Cabradilla, Francis, Murphy, Martin, Chermann, Barre-Sinoussi, Montagnier, Kalyanaraman, Schaffer, and McGrath will testify as to Dr. Gallo's knowledge of the significant characterization of LAV and its availability in large quantifies at the time the Science paper was submitted.
Drs. Chermann, Barre-Sinoussi, Martin, Francis, Cabradilla, McGrath, and Schaffer will testify that the statement at issue is both fallacious and clearly misleading.
IV. Applicable Standards of Conduct
For each allegation set forth above, ORI will prove by a preponderance of the evidence:
A. The applicable standard of scientific conduct in existence at NIH in 1983-84 for a
scientist in Dr. Gallo's position;
B. That Dr. Gallo's conduct seriously deviated from that standard;
C. That such conduct was not due to honest error or honest differences in interpretations
of data; and
D. That such conduct constitutes scientific misconduct.
In addition to the various witnesses and documents previously identified, ORI will call the following witnesses to testify on these four issues: Drs. Schaffer, Hadley, McGinnis, Bivens, Goldberger, Huth, Woolf, Francis, and Martin.
Based on the foregoing., ORI submits this Offer of Proof that Dr. Gallo committed scientific misconduct as described in the following allegations: A. Allegations A1, A2, A3, A4, and 8 in the aggregate, or any combination thereof that
includes allegation 8.
B. Allegation 8 alone. The facts underlying allegations A1-A4 are clearly relevant to, and
will be used to prove, a pattern of conduct by Dr. Gallo showing an intent to deceive
in allegation 8.
C. Allegation A4 alone. The facts underlying allegations A-A3 and 8 are clearly relevant
to, and will be used to prove, a pattern of conduct by Dr. Gallo showing an intent to
deceive in allegation A4.
Marcus H. Christ, Jr.
COUNSEL FOR THE OFFICE OF RESEARCH INTEGRITY
Chris B. Pascal
Public Health Division'
Office of Research Integrity Branch
5515 Security Lane, Suite 700
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