Gallo Case- Part 3 Part
2 Part 4 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"
A LETTER TO LEADERS OF SCIENCE
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.
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
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.
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:
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. . . . "
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.
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."
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.
A REPORT BY THE HHS OFFICE OF RESEARCH
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.
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
The first item concerns the role played by Gallo
Footnotes for page 469
The four counts I have quoted from the ORI
Report were well summarized systematically at the end of the article:
Inquiry Finds Misconduct By a Discoverer of the AIDS Virus,"
New York Times, 31 December 1992, p. Al.
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.
Gallo Guilty of Misconduct," Science, 8 January 1993,
"US report finds NIH's Gallo guilty of misstatement," Nature,
7 January 1993, pp. 3, 4.
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:
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).
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.
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
were followed by two summary paragraphs (p. 54), concerning broader
implications of Gallo's scientific practices. I reproduce these
paragraphs in full:
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.
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
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
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."
statement concerning LAV. The second main issue of concern to
ORI concerned a statement which Gallo had written in the article:4
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."
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)
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....'
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):'
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
A Statement by Gallo
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:
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.
"Misconduct" but Ignoring "Significant" Documents
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.
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:
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.
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
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.
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
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.'
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
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.
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.'
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.
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.'
'another isolate' is misleading, because the sequencing analysis
found that MOV is LAV.
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.
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:
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
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,
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.
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:
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?
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?
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
My answer is
that it cannot. Different scientists come to different conclusions,
depending on different attributions of importance to different factors.
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.
THE HHS APPEALS BOARD
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
made legalistic rulings whose effect is to institutionalize certain
low standards of behavior and to make it difficult to enforce higher
standards of behavior.
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
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?'
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
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."
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.
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.'
of the HHS adjudicative process shifted considerations from those
of scientific standards to legalistic manipulations. Scientists
were not participating.
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.
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
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
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
The Popovic Exoneration
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):
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
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.'
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
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.'
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."
new charges. As already documented, the ORI Report did indeed
suffer from serious defects.
defects were partly due to incompetence on several counts, some
of which I myself criticized in the manner described previously
in Part XI.
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
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.
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
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.
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):
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
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
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.'
Dropping the Gallo Case; Press Reports
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.
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.
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.
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
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.
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.'
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:
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
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....
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?
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.
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....
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.
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
charge against Popovic pulverized, ORI withdrew
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.
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.
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
performance of all personnel in the laboratory and to pay particular
attention to the accuracy of major publications which bear his name
- 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...."
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.
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,
the reporting by the Chicago Tribune.
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.
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.
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:
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?'
"The Aftermath of the Gallo Case"
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.
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
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]--
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.'
use of the word 'expert provided a backdrop of authority for the
Science article. How legitimate was this backdrop?
selection of certain so-called "experts' directed certain conclusions
in certain directions. Another selection of scientists would have
provided other directions.
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
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
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):
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.'
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."
Goodstein raised serious points, typical in file making, and deserving
an answer. I replied on 4 May 1994 addressing myself to these points.
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.
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.
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.
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).
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.'
for page 492- Continued
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.
remains for readers to evaluate the way Science, Goodstein, and
I exercised our respective responsibilities, especially our journalistic
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?
printed an item labeled "corrections and clarifications.7
In light of Goodstein's letter to me, I conclude that this item
Footnotes for page 494
[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.]
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
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.
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
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
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]
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.)
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.)
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'
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."
- 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.
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
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
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]
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."
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."
"only chance" ultimately was not "the help of independent colleagues"
but lawyers and what some people call "legal standards."
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").
call Sciences journalism tendentious, and I object.
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.
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.
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:
the ORI Offer of Proof.
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
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
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
The Richards Panel vis-à-vis the Appeals Board
Panel was systematically rejected by the Appeals Board. In the first
place, of course, no member of this panel was on the Appeals Board.
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."
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 .... "
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."
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:
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
- the withholding of information from this panel by NIH; and
- the ultimate explicit rejection of this panel by HHS.
history of the NAS-nominated Richards Panel represents failures
of responsibility and evasions of responsibility across the board:
NIH and HHS for having solicited the NAS to nominate a panel of
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
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?
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
Certified Mail sent to Gallo's lawyer, Joseph Onek,
and to the Office of the General Counsel, ORI 6 July 1993
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 ....
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:
assuming Respondent engaged in the alleged conduct, this fact alone
would not impugn Respondent's research integrity.
his integrity is not impugned by the conduct, no administrative
action to protect the federal government interest is needed or appropriate.
the label to Respondent in such circumstances would be fundamentally
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
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:
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.
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."
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.
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.
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 ....
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
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 ....
8---ORI must offer proof that the statement in question falsely
reported the status of LAV research.
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 ....
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.
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
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 ....
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.
with this ruling, these proceedings will be dismissed with regard
to any allegation for which ORI does not present the offer of proof
s/Norval D. (John) Settle
s/Cecilia Sparks Ford
President Panel Member
Excerpts from the "DECISION" of the Appeals Board
SUBJECT: Mikulas Popovic, M.D.
3 November 1993
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 ....
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
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 ....
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:
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...
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 ....
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
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.]
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
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
2-6. In its Final Report to the allegations of scientific misconduct
against Dr. Robert C. Gallo, the ORI concluded that
Dr. Gallo committed
scientific misconduct with respect to his following statement published
in his article in Science:2
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 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:
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.
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 ....
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.
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..
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
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"....
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...
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.
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,
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 ....
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.
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,
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 ....
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
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.
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.
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.
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 ....
2. Dr. Gallo's Misappropriation and Misrepresentation of
the HUT-78 Cell Line.
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 ....
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,
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 ....
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
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.
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
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.
3. Dr. Gallo's Restrictive Conditions on Provision of the H9
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.
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,
onerous conditions for scientists not in his favor; and (4) otherwise
gave preferential treatment to scientists whom he favored.
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').
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:
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.
Dr. Gallo waited over a month to respond to the CDC's request for
uninfected H9. See Exhibit H-92.
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."
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:
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.
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.
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.
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
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.
Concerning Specifically the Statement Published in
the Science Article: Dr. Gallo is charged
by ORI with falsely reporting
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 ....
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 ....
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 ....
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 ....
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.
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.
.... 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."
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.
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."
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...
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
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.
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.
Barre-Sinoussi, Martin, Francis, Cabradilla, McGrath, and Schaffer
will testify that the statement at issue is both fallacious and
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
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
of data; and
D. That such conduct constitutes scientific misconduct.
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:
A1, A2, A3, A4, and 8 in the aggregate, or any combination thereof
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.
Debra M. Parrish
THE OFFICE OF RESEARCH INTEGRITY
Chris B. Pascal
Office of the General Counsel
Public Health Division'
Office of Research Integrity Branch
5515 Security Lane, Suite 700
Rockville, MD 20852