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The
Gallo Case- Part 3 Part
1 Part
2 Part 4 Part
5
Part
3 - Contents
X. A LETTER TO LEADERS
OF SCIENCE pp 467-468
XI. A REPORT BY THE HHS OFFICE OF RESEARCH
INTEGRITY (ORI) pp 469-479
XII. THE HHS APPEALS BOARD pp 480-522
Note: Page numbers refer
to corresponding pages in the paperback edition of the book "Challenges"
X.
A LETTER TO LEADERS OF SCIENCE
Following
the exchange with Gallo, I wrote on 30 November 1992 to leaders
in science, pointing to what I regarded as a scandalous situation
created by the NIH reports. Allan Bromley at the time was Presidential
Science Advisor, on leave from Yale.
To: Allan
Bromley
Louis Sullivan, Secretary HHS
James Mason, Assistant Secretary HHS
Bernadine Healy, Director, NM
The Council, National Academy of Sciences
Frank Press, President, National Academy of Sciences and others
1. The
handling of the Gallo case (among others) by the leaders of science
has been a profound mess. The leaders' failures of responsibility
force individuals either to accept that things are going to get
worse before they get better, or to spend an inordinate amount of
time and effort documenting these failures and attempting to deal
with them. Expanding such time and effort detracts from doing science.
2. I
enclose a letter which Gallo wrote to me. In reviewing the evidence
to write my reply, and especially reviewing the OSI Draft Report
of June 1991 and the OSI Report of March 1992 as reported in the
media, I was struck by an aspect of these reports, namely:
(a)
The OSI Reports, supported by the NIH scientific advisers, found
that Gallo and his lab engaged in a number of practices, specifically:
"lack of laboratory records ... lack of attention to details
which resulted in false representation
... lack of scientific rigor ... breached overall responsibility
... to ensure the accuracy of the paper ... created and fostered
conditions that give rise to falsified / fabricated data and falsified
scientific reports. . . . "
pg 468
(b) At
the same time, the OSI investigators and two out of three NIH scientific
advisers (other than the Richards Panel) declared that there was
no "misconduct" on Gallo's part, in the technical sense defined
by the Public Health Service, namely "other practices that seriously
deviate from those that are commonly accepted within the scientific
community for proposing, conducting, or reporting research."
However, the OSI investigators and all three NIH scientific
advisers judged that these practices "merit significant
censure" in the conclusions of the OSI Draft Report.
Therefore,
a remarkable conclusion follows from the logic of the OSI investigators
and the two NIH scientific advisers, to wit: a number of practices
which merit "significant censure" in the OSI Draft Report,
and are listed above in boldface italic, do not seriously deviate
from those that are commonly accepted within the scientific community.
Since the '"significant censure" was deleted from the OSI Report
of March 1992, one can further conclude that according to revised
and more current views, these practices, which do not seriously
deviate from those commonly accepted within the scientific community,
also do not merit "significant censure."
3. Instead
of actively doing something about this situation, which I regard
as scandalous, the leaders of science are continuously engaged in
obfuscations and evasions of responsibility. I conclude that the
failure of the scientific community's leadership, whether in government
agencies such as NIH and HHS, or the NAS, has been monumental. You
are in a position to make a difference. I challenge you to do so.
XI.
A REPORT BY THE HHS OFFICE OF RESEARCH
INTEGRITY (ORI)
§1.
Conclusions of the ORI Report
The HHS Office
of Research Integrity (ORI) on 30 December 1992 issued a report
which agreed with some findings and reversed other findings of the
OSI Report and NIH Director Healy.
In Crewdson's
articles, he did not make allegations. He reported factually, but
the facts raised questions and issues perceived in various ways
by different people. At the end, the ORI Report lists several conclusions
concerning some of the issues raised by Crewdson's reporting, and
asserts (pp. 52-53): "ORI concurs with the OSI finding that
Dr. Gallo did not commit scientific misconduct in relation to the
several issues in the Chicago Tribune article, and the noted discrepancies
or issues raised by the 1984 Popovic paper (with the exception of
the statement that LAV had not been put in a permanent cell line,
discussed in the preceding section). However, ORI believes that
many of Dr. Gallo's actions reflect a pattern of conduct that must
be censured even though they do not constitute scientific misconduct."
The ORI Report goes on to list four items (p. 53) which they judge
deserving "censure."1
The first item concerns the role played by Gallo
Footnotes for page 469
1
The four counts I have quoted from the ORI
Report were well summarized systematically at the end of the article:
'"Federal
Inquiry Finds Misconduct By a Discoverer of the AIDS Virus,"
New York Times, 31 December 1992, p. Al.
The
ORI Report received extensive coverage in the press. I list a few
more articles here:
"'New HHS Report Faults AIDS Researche"' Washington
Post 31 December 1992, p., A4.
"'U.S.: Top AIDS scientist guilty of misconduct", Chicago
Tribune, 31 December 1992, p. 4.
"'Righting the record on AIDS research," editorial, Chicago
Tribune, 31 December 1992.
'"HHS:
Gallo Guilty of Misconduct," Science, 8 January 1993,
p. 168.
"US report finds NIH's Gallo guilty of misstatement," Nature,
7 January 1993, pp. 3, 4.
"Gallo
on the rack--The latest government pronouncement raises questions
about the office itself as well as about Gallo," editorial in
Nature, 7 January 1993, p. 1.
pg
470
as a reader
- referee for a scientific article submitted by French scientists
from the Institut Pasteur, including Montagnier (head of the laboratory),
and Francoise Barre-Sinoussi (one of the principal researchers),
whose name appeared first on the paper. This first item listed states:
-Dr. Gallo's
role in the Barre-Sinoussi paper: OSI found that Dr. Gallo's actions
were "gratuitous, self-serving, and improper." It was the admission
by Dr. Montagnier that he may have seen the galley proofs for the
article, and did not raise any objections to the material added
by Dr. Gallo, that led ORI to conclude that Dr. Gallo's actions
did not constitute scientific misconduct. Nonetheless, ORI believes
that Dr. Gallo's actions reflect Dr. Gallo's propensity to misrepresent
and mislead in favor of his own research findings of hypotheses.
The other three
items read as follows ("LTCB" refers to Gallo's laboratory, Laboratory
of Tumor Cell Biology).
-Dr. Gallo's
failure to fulfill his obligations as the senior author: In light
of his role as senior author of the Popovic paper, Dr. Gallo must
bear substantial responsibility for the numerous discrepancies in
the Popovic paper, including the four instances of scientific misconduct
attributed to Dr. Popovic The scientific and public health importance
of the research undertaken in the LTCB imposed an obligation for
accuracy in reporting the methodologies and results of this groundbreaking
research--an obligation that Dr. Gallo failed to meet.
-Supervision of the LTCB by Dr. Gallo: Especially in light of the
groundbreaking nature of this research and its profound public health
implications, ORI believes that the careless and unacceptable keeping
of research records revealed by the OSI inquiry and investigation
reflects irresponsible laboratory management that has permanently
impaired the ability to trace the important steps taken.
-Failure to determine the source of [the cell line] H92
in a timely manner, and restrictive conditions on access of other
researchers to H9: Dr. Gallo's failure to determine in a
Footnotes for page 470
2 The cell line H9 was "the
permanent cell line in which HTLV-III grew," according to the ORI.
p. 51.
pg
471
timely manner
the derivation of the cell line that supported the HTLV-IIIB culture
and the imposition of restrictive conditions on its distribution
reflect Dr. Gallo's indifference to acknowledging promptly the contributions
of others and to sharing of research materials of critical public
health importance.
These conclusions
were followed by two summary paragraphs (p. 54), concerning broader
implications of Gallo's scientific practices. I reproduce these
paragraphs in full:
Overall,
ORI finds that the events surrounding the discovery of the AIDS
virus and the development of a blood test are highly regrettable
and unfortunate. The scientific trail of evidence for findings of
such profound public health importance is so muddled that the source
of a critical cell line remained uncertain until well after publication
of the Popovic paper, and the source of a critical viral isolate
(MOV) remains unknown. A disregard for proper scientific record
keeping in groundbreaking research played a major role in this failure.
Furthermore, a failure to fully disclose all aspects of the research,
and a propensity to exaggerate LTCB accomplishments, undermine the
legitimate and important accomplishments of Dr. Gallo and Dr. Popovic.
ORI believes that Dr. Gallo and his research team were instrumental
in identifying the AIDS virus and protecting the blood supply from
contamination with the virus. To have these critical accomplishments
diminished by the actions documented in this investigation is a
tragedy for science, and for Drs. Gallo and Popovic.
The ORI Report
made a distinction between certain issues on which Gallo should
receive "censure' as in the above four counts, and another on which
Gallo was guilty of "scientific misconduct," as we shall discuss
below. This distinction was to haunt ORI in its dealings with the
HHS Appeals Board later. Compare with the "Offer of Proof' to the
Appeals Board, excerpts from which are reproduced in Appendix 3
of the next part. In this "Offer of Proof,' ORI attempted to tighten
and upgrade its evaluation from "censure" to 'misconduct,'
and generally used stronger language.
Aside from
being aware of items giving general conclusions such as those listed
above, I think it may be useful for readers also to be aware more
specifically of the way the ORI Report analyzed some of the points
of contention. The French virus called
pg
472
LAV was at
the center of attention, because of the possibility that it was
misappropriated by Gallo. Especially, a question was raised as to
the relation between the virus HTLV-IIIB alleged by Gallo to have
been grown in his laboratory, and the French virus LAV. Gallo with
several coauthors, notably Popovic, after whom the article is named,
had published an article in Science, in which they claimed to have
discovered a method to grow the AIDS virus continuously in a cell
line.3
The misappropriation
issue. The ORI Report describes the first of its specific concerns
as follows (p. 11):
(1) Did HTLV-IIIB's
affinity to LAV reflect a misappropriation of LAV or an accidental
contamination of the 'pool' culture? A corollary issue was whether
the LTCB had other HIV isolates available that could have been used
to develop the AIDS blood test on approximately the same timeline
as development of the test with HTLV-IIIB.
On this first
issue, after reviewing evidence, the ORI came to the conclusion
(p. 28): 'ORI supports the OSI finding that it is not possible to
resolve the question of misappropriation versus contamination."
A questionable
statement concerning LAV. The second main issue of concern to
ORI concerned a statement which Gallo had written in the article:4
These findings
suggest that HTLV-III and LAV may be different. However, it is
possible that this is due to insufficient characterization of LAV
because the virus has not been transmitted to a permanently growing
cell line for true isolation and therefore has been difficult
to obtain in quantity.
Footnotes for page 472
3 The article is entitled
'Detection, isolation, and continuous production of cytopathic retroviruses
(HTLV-III) from patients with AIDS and pre AIDS,' by Mikulas Popovic,
M. G. Sarnghadaran, Elizabeth Read, and Robert C. Gallo. This publication
is referred to through the ORI Report as 'the Popovic paper."
4
Despite the fact that there were several coauthors, the ORI Report
states (p. 46): "ORI finds Dr. Gallo wrote the disputed statement
and is responsible for the concomitant scientific misconduct.'
pg
473
The ORI concern
was then expressed as follows (p. 12)
(2)
Was the statement in the Popovic paper that LAV had not been transmitted
to a permanently growing cell line a falsification of the status
of LAV research?
The ORI Report
asserts (p. 29): "The underlined statement is a misrepresentation.
LAV had been transmitted to a permanently growing cell line within
the LTCB by the authors of this statement. After reviewing the available
evidence, OSI found that LAV had been grown in a permanent cell
line in the LTCB several months prior to the writing of that statement.
Dr. Gallo asserted that the clause, 'because the virus has not been
transmitted to a permanently growing cell line," was not false because
it did not refer to the accomplishments of the LTCB, but referred
to the accomplishments of the French researchers. Dr. Gallo alleged
that when the statement was written, the French had not grown LAV
in a permanent cell line. The OSI experts could not agree on the
proper interpretation of the clause; some believed that it referred
solely to the French, others believed that it indicated that no
laboratory had grown LAV in a permanent cell line. OSI found that
the statement was a misrepresentation but did not find Dr. Gallo
guilty of scientific misconduct stemming from this allegation....'
However, ORI
came to a different conclusion from OSI since its report asserts
(p. 43): "In sum, ORI finds that Dr. Gallo falsely reported the
status of LAV research when he wrote the statement, and this constitutes
scientific misconduct. The explanations that Dr. Gallo preferred
for the statement are neither credible when the evidence is considered,
nor do they vitiate the impropriety of falsely reporting the status
of LAV research in the Popovic paper. Even if the statement can
be technically interpreted to refer to the accomplishments of French
researchers, an interpretation that ORI disputes, ORI believes that
Dr. Gallo is guilty of misconduct because the statement is intended
to mislead the research community with respect to the ability of
LAV to be grown in a permanent cell line and, thus, constituted
falsification in reporting research."
In this evaluation,
the ORI came to the same conclusion as the Richards Panel, which
they quote in the report (p. 50): 'The statement that LAV had not
been transmitted in a permanent cell line is simply false, and was
known to be false at the time the paper was written. This is one
of the most glaring faults in the paper and is part of the pattern
of misrepresentation in the discussion
pg
474
of the problem
of continuous culture. There is no way in which Dr. Gallo can be
excused from sharing the blame for this misstatement."
Not all scientists
shared the point of view of ORI or of the Richards Panel. For an
example, I quote from Science (8 January 1993, p. 170):'
In spite
of such protestations [by Gallo's lawyer against the ORI Report],
even some of Gallo's allies aren't buying the line that he did nothing
wrong. Nobel Prize-winning retrovirologist Howard Temin of the University
of Wisconsin concedes Gallo was wrong not to describe the lab's
use of LAV. 'That's clearly improper;" says Temin. He also calls
Gallo's reasons for not describing that work in the paper 'obviously
silly' and says ORI was "quite right to reject them.'
Still, says Temin, the ORI Report comes to a "very unfortunate"
conclusion because Gallo's behavior, though not collegial, was not
misconduct. Temin says he believes misconduct applies to researchers
who have falsified "a major thing." In the Gallo case, the misrepresentations
were "minor things" says Temin--things that did not affect the paper's
conclusions. Temin argues that Gallo's transgressions were a matter
of denying credit to a competitor--not serious falsification. Temin
also strongly objects to ORI's conclusion that Gallo's failure to
describe having cultured LAV impeded other researchers. 'LAV and
IIIB are the same," he says. Whether researchers got their samples
"from Gallo or Montagnier couldn't have made any difference in the
world.'
pg 475
§2.
A Statement by Gallo
The findings
of HHS were reported at length in the press, and notably in Crewdson's
article "U.S.: Top AIDS scientist guilty of misconduct' in the Chicago
Tribune of 31 December 1992. The article was accompanied by a Gallo
statement, which deserves to be reproduced here in full:
After reviewing
everything I and my colleagues have ever published on the discovery
of the AIDS virus and the development of the AIDS blood test, ORI
could only take issue with a few trivial mistakes and a single sentence
Written by me.
The new and extraordinary finding that the sentence I wrote is false
is utterly unwarranted. It is based on a distorted interpretation
of the sentence. Numerous NIH scientists believe the sentence means
what I intended for it to say, as did the co-authors of the article
and previous OSI scientific reviewers.
For the record, I intend to appeal this finding in the ORI Report
and expect to have the finding overturned.
On a broader level, this endless and incompetent government investigation
should be of concern to everyone seeking to advance medical knowledge.
My laboratory's contributions to the advancement of medical science
are undisputed. For the past three years, however, I have spent
a substantial amount of my time responding to issues involving the
OSI and ORI investigations. These investigations have diverted not
only my personal time and the time of others in my laboratory, but,
perhaps most importantly, our collective creative thinking. We cannot
recapture that time. We cannot even begin to calculate the amount
of potentially lifesaving research that has been lost. Those who
seek to perpetuate investigations that result in petty and misguided
conclusions like those in the ORI Report must account for this lost
research. They must understand that, while the uncovering of genuine
scientific misconduct is important, the mindless pursuit of fantasized
misconduct can have devastating consequences for scientific research.
The misguided finding of the ORI Report have no bearing on the validity
and importance of the research on AIDS conducted by my laboratory.
My intention, while the appeal is pending, is to continue to conduct
research on AIDS, cancer, and other diseases. Looking toward the
future will be much more productive than reviewing the past.
pg 476
§3.
"Misconduct" but Ignoring "Significant" Documents
Although the
ORI Report officially used the key word misconduct," with obvious
effects on the public relations platform, it was still defective
in not taking into account, let alone releasing, "significant" documents
from the NIH files.
There was some
evidence that the ORI Report, despite concluding "misconduct" on
Gallo's part in one instance, nevertheless still did not contain
a substantial amount of information which was withheld in the previous
NIH Report of March 1992.
Lyle Bivens,
Director of ORI, had the courtesy to send me directly a copy of
the report, and I then replied with a letter dated 13 January 1993,
formulating criticisms of this report as follows:
Significance
of the sequencing analysis. The sequencing analysis and its
conclusion that 'MOV and HTLV-IIIB were identical to LAV-LAI' are
mentioned only once in the ORI Report (one line, p. 13). Everywhere
else in the ORI Report, the significance of this finding, even its
existence, is ignored. I shall list several examples.
(a)
Contamination. On page 27, the ORI Report states that 'ORI concludes
conditions in the LTCB may have created an environment that resulted
In LAV/LAI's contamination of other cultures. The ORI Report further
concludes that the contamination could have occurred between late
October 1983, when the September LAV samples were taken from the
freezer, and late February 1984, when HTLV-IIIB infected the H9
cell line.' On page 28, the ORI Report states: 'ORI supports the
OSI finding that it is not possible to resolve the question of misappropriation
versus contamination.'
The
ORI Report is misleading. Indeed, LAV/LAI is one and the same as
HTLV-IIIB according to the sequencing analysis. The ORI Report gives
no evidence why it supports the finding of OSI that it is not possible
to resolve the question of misappropriation-, worse, it gives no
evidence that ORI even attempted seriously to probe into that question.
(b)
A single isolate. The ORI Report repeatedly has sentences to
the effect that HTLV-IIIB and LAV are different Isolates. For example,
on page 45, the ORI Report states: 'ORI notes that Dr. Gallo's failure
to reveal the utility of LAV effectively ensured that
pg 477
most researchers
would use HTLV-IIIB in AIDS research because they would have thought
it to be the only HIV isolate grown in a permanent cell line. Consequently,
this virtually ensured HTLV-IIIB's preeminence in AIDS research.'
Again on page 52: "in fact, as noted above, revealing that LAV could
be grown in a permanent cell line would have indicated LAV's research
utility, indicated that HTLV-IIIB was not the only isolate that
could be used in the development of an AIDS test, and would have
encouraged others to pursue the work with LAV.'
Both statements
are misleading, because the statements accept that LAV was another
isolate, which is not true. The most serious misrepresentation here
is that Gallo said repeatedly that HTLV-III was different from LAV,
and thereby misled researchers, who were not aware that the isolates
were one and the same. ORI fails to even mention this misrepresentation,
and thereby contributes to it. See also the next item in the same
vein.
(c)
Recognition by Gallo-Popovic that LAV is HTLV-III. On page 34,
the ORI report quotes an early version of the Popovic manuscript,
including one passage which Gallo deleted, but unfortunately the
ORI Report f"s to quote another even more crucial passage deleted
by Gallo, to the effect that LAV "is described here as HTLV-III'.
This is a serious omission from the ORI Report.
(d)
Misreporting of evidence. On page 26, the report states: 'The
evidence shows that neither Dr. Gallo and his colleagues nor the
Pasteur scientists knew before 1991 that LAV/LAI had been present
in the LTCB since September 1983.'
This
sentence is misleading, as shown by the Popovic sentence mentioned
in the preceding item, that LAV "is described here as HTLV-III.'
This sentence dates back to Fall 1983, and shows that Popovic and
Gallo did know that LAV had been present in the LTCB in 1983. Gallo
and Popovic received several samples of LAV/BRU. One of these samples
had unknowingly been contaminated with LAV/LAI at the Institut Pasteur.
The fact that Gallo and Popovic were not aware they were working
with LAV/LAI is irrelevant, because they were working with LAV/BRU,
and they knew it well.
(e)
MOV. On page 17 the ORI Report states: "Another isolate, MOV,
had been growing in a permanent cell line since November 1983. On
6 January 1984, MOV became the first retrovirus to be used in ELISA
tests by Dr. Sarngadharan.'
Calling MOV
'another isolate' is misleading, because the sequencing analysis
found that MOV is LAV.
pg 478
The whole
discussion about MOV (pp. 17, 19, 20, 2 1) ignores this finding,
and is therefore misleading. The conclusion that MOV became the
first retrovirus to be used in ELISA tests by Dr. Sarngadharan,
combined with the fact that MOV is LAV, shows that the French virus
was the first one used for their blood test. This conclusion deserved
to be stated clearly in those terms in the ORI Report, but it was
not so stated.
Withholding
of documents. Although the ORI Report corrected some defects
and failures of the OSI Report listed in the 'Dissent and Critique'
of the OSI Report by Suzanne Hadley, nevertheless it perpetuated
some of the major flaws of the OSI Report, as exemplified above.
The ORI Report was still far from satisfactory, and only represented
a second stage in the evolution of the HHS investigative process,
after Suzanne Hadley had been dismissed by Bernadine Healy. For
a further evolution, readers can see the 'Offer of Proof' prepared
by ORI for the Appeals Board, even though this "Offer of Proof'
was ultimately not used. (See Appendix 3 of the next part.)
Even more seriously,
the ORI Report was unsatisfactory because certain crucial documents
were still not being mentioned, let alone released. Indeed, the
"Dissent and Critique" of the OSI Report reported in Dan Greenberg's
Science and Government Report of 1 June 1992, stated:
Material
apparently damaging to Gallo, including some of his own testimony,
has been deleted. Specious, unsubstantiated arguments adduced by
Gallo and his colleague, Mikulas Popovic, have been accepted unquestioningly
by OSI. The OSI even constructed its own arguments exculpatory to
Gallo.
A number of OSI arguments and conclusions cannot be substantiated-,
a number are flatly refuted by the evidence. Moreover, in a number
of instances, OSI has failed to deal with and even mention highly
significant pieces of evidence known to be in its possession. Perhaps
most serious, the final OSI Report gives only superficial, misleading
consideration to the implications of the highly significant virus
sequencing studies. As a result, the OSI has irresponsibly evaded
the central question in the entire investigation, the question of
Gallo's possible misappropriation of the Institut Pasteur HIV isolate,
LAV.
pg 479
Even with their
ongoing evolution, the ORI Report made no mention that NIH had in
its possession additional documents that are 'highly significant.'
These documents were also withheld from the Richards Panel. It was
ORI's responsibility to consider these documents, but the ORI Report
gives no sign that ORI has taken these documents into consideration.
Certainly the ORI Report did not mention these documents, and a
fortiori it did not make them available to the scientific community.
§4.
My Conclusions
As we shall
see in connection with an ongoing investigation by the Subcommittee,
Dingell has asserted publicly that he was able to obtain documents
which NIH systematically tried to withhold, although as late as
June 1993, he had not been able to obtain all such documents. (See
his public opening statement at the hearings of 21 June 1993, reproduced
in its entirety below.) Therefore one can raise the following questions:
1.
Concerning HHS and NIH: Did HHS withhold documents from its
own Office of Research Integrity? Did NIH withhold such documents?
Were higher-ups at HHS (Secretary and Assistant Secretary) aware
that such documents were withheld by NIH If they did not withhold
such documents themselves?
2.
Concerning ORI itself: Was ORI aware that such documents were
withheld? If yes, why was such withholding not stated in the ORI
Report? If no, what trust can be placed in an office which is so
manipulated by others in its own organization?
3.
Concerning the scientific community: How can the scientific
community rely on official bodies (NIH, HHS-ORI, Richards Panel)
to get complete documentation and information concerning the Gallo
case?
My answer is
that it cannot. Different scientists come to different conclusions,
depending on different attributions of importance to different factors.
The scientific
community could not rely on the Dingell Subcommittee either, since
they never issued a formal report. The next best thing was a Staff
Report, prepared with the cooperation of Suzanne Hadley, see below.
XII.
THE HHS APPEALS BOARD
Various appeals
from ORI were considered by the HHS Appeals Board, among which were
the appeals by Popovic and Gallo. The ultimate dependency of the
NIH and HHS investigations on the Appeals Board finished the long
process of eliminating scientists from the review of the Gallo case,
and turning it over to lawyers, whose point of view is legalistic,
not scientific. Some people have called this "due process." I shall
list here some of the conditions imposed by the Board on ORI in
July 1993.
§1.
Legalistic Rulings
The Board
made legalistic rulings whose effect is to institutionalize certain
low standards of behavior and to make it difficult to enforce higher
standards of behavior.
(a)
The Board found that 'anticipatory writing" (claiming that experiments
were performed when in fact these experiments were not performed)
in an NIH grant application is NOT scientific misconduct. 1
Footnotes for page 480
1
One
decision in this respect had to do with the case of Rameshwar Sharma.
According to the Washington Post ('U.S. Loses Science Fraud Case
on Appeal,' 11 August 1993, p. A13): 'In an Internal Investigation,
Sharma's employer, the Cleveland Clinic Foundation, found that the
scientist had made misstatements but that he had not committed intentional
fraud. He had engaged in 'anticipatory writing--claiming to perform
certain experiments that would soon be performed.' According to
the Washington Post ' ORI proposed disciplinary actions against
Sharma that Included excluding him from Public Health Service advisory
boards for three years and holding any of his applications during
that period to a higher standard of review.' However, again according
to the Washington Post . the appeals panel reported that
'we find that ORI failed to carry its burden or proving scientific
misconduct by a preponderance of the evidence" and that 'ORI's findings
are not supported and the proposed administrative actions are not
justified.' An aide to Dingell is quoted as commenting: "It's a
very curious finding. Is this an admission that falsification of
a grant application is okay?'
pg 481
(b)
By a ruling of the Board, ORI must not only prove that scientific
misconduct occurred, but ORI must also prove the absence of honest
error relative to the alleged misconduct, i.e., ORI must prove a
negative.
(c)
The Board ruled that falsification, fabrication, and the like are
not grounds for a finding of scientific misconduct unless the respondent
'reasonably could have anticipated at the time of his alleged conduct
that such conduct, if proved, would constitute ,scientific misconduct."
(d)
The Board ruled that scientific misconduct does not include 'falsification
or any other conduct which does not seriously deviate from commonly
accepted practices within the scientific community....' According
to the Board's logic, if falsification becomes a universal practice
among scientists, then it receives the legal approval of government
agencies which are supposed to overview the maintenance of scientific
standards for government grants and government laboratories.
Informative
analyses of these impositions by the Appeals Board are given in
the articles 'Hearing Process Proves a Challenge for ORI" (Science,
18 June 1993, p. 1714), and 'Case Against Gallo Faces Tough Appeals
Process" (Science and Government Report, 15 October 1993). Extensive
excerpts from the conditions set by the Appeals Board on ORI will
be reproduced in an appendix, so that readers can verify for themselves
what ORI was subjected to, especially with respect to what is called
an 'offer of proof' for ORI's allegations. Among other things, HHS
was under the threat of a lawsuit if its ruling did not meet certain
legal criteria. Indeed, one of the conditions stated: 'If we do
not receive such an offer of proof with respect to each allegation,
we would dismiss this proceeding with regard to that allegation.
To do otherwise would result in this department committing its resources
for a proceeding which could not lead to a legally supportable result
in ORI's favor.'
The focus
of the HHS adjudicative process shifted considerations from those
of scientific standards to legalistic manipulations. Scientists
were not participating.
(a) The
Federation of American Societies for Experimental Biology (FASEB)
declined an invitation of ORI to participate at the hearing stage,
because according to Science (18 June 1993, p. 1714), 'the process
was more judicial than scientific...,' among other reasons.
(b) At
first, the Board refused to include a scientist as a member, even
though the Board's rules specifically provide for this option, and
ORI even requested it. The Board consisted only of government
attorneys.
pg 482
This same
issue of Science also reported the reaction of ORI officials: 'ORI
director Lyle Bivens acknowledges that the appeals process is not
working in the way he envisioned it. Bivens says he hoped that the
Board would have included scientists, rather than a solid cast of
government attorneys. Indeed, he says, he is 'disappointed' by the
failure of ORI's early efforts to get the active participation of
the scientific community at the hearing stage, as opposed to during
Investigations."
The Gallo investigative
process started with HHS soliciting the National Academy of Sciences
for the nomination of a panel 'with a view to ensuring both the
fact and appearance of objectivity." As NIH Acting Director William
Raub wrote to Fred Richards 16 April 1990: 'Throughout, your expertise,
independence, and objectivity will be key elements in ensuring a
thorough and fair review." Then the NIH-HHS process ran its full
course whereby the scientists were manipulated, information was
withheld from them, and finally they were completely eliminated
and put down at the time the Appeals Board issued certain of its
rulings (cf. Appendix 1).2
§2.
The Popovic Exoneration
Popovic was
the first named author of the Science article under questioning.
As summarized in the article "Popovic is Cleared on All Charges;
Gallo Case in Doubt' (Science, 262, 12 November 1993, p. 982):
ORI's case
against Popovic boiled down to his statement that certain experiments
were 'not done' when they had in fact been done, 3
that a '10% figure in a table was not supported by data," and that
he claimed that certain fluids were 'first shown' to contain signs
of virus replication before they were mixed together, when that
was not the case. The Board noted that none of these alleged misrepresentations
would have made any difference to the conclusions of the paper.
Footnotes for page 482
2
Subsequently, as reported in Science (12 November 1993, p. 982): 'if
the [Gallo] hearing is held, the Board's three government lawyers
will be joined by a scientist, Jules Younger, an emeritus virologist
at the University of Pittsburgh. Both sides requested the addition
of a scientist as a full voting member of the board.'
3
See below for further comments on this "Not Done' in connection
with the Richards testimony; and also Appendix 2 where I quote a
more extensive passage &from the ORI's comments on the 'Not
Done' question.
pg 483
Popovic was
completely exonerated by the Appeals Board, which even criticized
the ORI by stating: "One might anticipate that from all this evidence,
after all the sound and fury, there would be at least a residue
of palpable wrongdoing. That is not the case.'
Faced with
the Popovic verdict, ORI Director Lyle Bivens was quoted in the
Chicago Tribune (5 November 1993, p. 18): "My initial reaction is
one of outrage. The Board is way off the mark."
Raising
new charges. As already documented, the ORI Report did indeed
suffer from serious defects.
(a) The
defects were partly due to incompetence on several counts, some
of which I myself criticized in the manner described previously
in Part XI.
(b)
A problem arose from ORI having determined that some actions were
not 'misconduct' but did merit 'censure.' From the point of view
of the Appeals Board, only the legalistic category of 'misconduct'
had any relevance to their ruling (see for instance the precise
quote below).
(c)
The defects of the ORI Report were also partly due to NIH withholding
from ORI information in the NIH files, as well as ORI's de facto
inability to go after this information, or to ask the proper outside
sources for this information (e.g. Suzanne Hadley). Bernadine Healy's
dismissal of Suzanne Hadley from the investigation had successfully
derailed the investigation.
Partly because
various sources criticized the ORI Report, and partly because the
ORI staff was genuinely trying under difficult circumstances, ORI
attempted to improve its case for presentation to the Appeals Board.
For instance, it attempted to bring up new evidence, and to upgrade
certain actions from meriting censure to actual misconduct. The
matter was reported as follows in the article 'U.S. may not fight
appeal by Gallo" (Chicago Tribune, 10 November 1993, p. 1): "For
most of the past year, four ORI lawyers have worked virtually full
time in preparing to argue the Gallo case, which is detailed in
a 99-page offer of proof, or "proffer,' they submitted to the Appeals
Board last August.,4
Footnotes for page 483
4
Having learned of this "Offer of Proof' from Crewdson (see also
Dan Greenberg's "Case Against Gallo Faces Tough Appeals Process'),
Science and Government Report 15 October 1993), I wrote to ORI for
a copy, which I received by return mail. I shall reproduce excerpts
from this 'Offer of Proof' in Appendix 3. Since the document was
not mentioned in magazines such as Science. I distributed
30 copies, and also sent a copy to the Council of the National
Academy of Sciences, as well as to Ellis Rubinstein, news
editor of Science.
pg 484
The price of
getting entangled in legalistic categories became explicitly apparent
in the confrontation between ORI and the Appeals Board. The Appeals
Board rejected the ORI's attempt to improve the case, and the Appeals
Board's decision stated (p. 72):
During the
course of the hearing and in post-hearing briefs, ORI attempted
to raise other issues concerning the accuracy of the Science paper.
We found introduction of these issues to be inappropriate and untimely.
In effect, ORI was attempting to reopen allegations of misconduct
on which it had not made findings of misconduct in the final report
which served as the basis for this proceeding. While ORI attempted
to characterize these matters as merely going to Dr. Popovic's credibility,
ORI had not even identified these matters as part of the pattern
of conduct it said (in the Offer of Proof submitted several weeks
prior to the hearing) it would show to prove Dr. Popovic's intent.
Thus, Dr. Popovic did not have fair notice that these issues would
be addressed, and we ruled that they were outside the scope of this
hearings.5
The attempt
to present an improved case was subsequently described as follows
in "The Aftermath of the Gallo Case" (Science, 263, 7 January 1994,
p. 22): 'in interviews after the Popovic decision, ORI also contended
that the Board refused to hear evidence of a 'pattern of behavior'
to prove intent in the Popovic case. But Rebecca Dresser, a misconduct
expert [sic] at the Case Western Reserve University Law School who
examined the Appeals Board decisions at Sciences request, says the
Board drew the line only when ORI tried to raise a serious charge
not in its investigative report.'
At the same
time, Science did not give any indication to its readers concerning
the substance of the issues, listed extensively in the ORI 'Offer
of Proof.' (See Appendix 3.)
Footnotes for page 484
5
The paragraph continues: "We nonetheless discuss
these issues briefly here since ORI continued to press them and
since they were raised in a public forum.'
pg 485
§3.
Dropping the Gallo Case; Press Reports
The Chicago
Tribune article of 10 November 1993 (mentioned above, page 10) reported:
'ORI officials acknowledged there was nothing to prevent them from
opening a new and broader investigation of Gallo based on evidence
that has come to their attention since the NIH investigation was
concluded. But they admitted that such a decision might cast them
as 'zealots who are tormenting this guy.'"
Given the legalistic
conditions imposed by the Appeals Board, their exoneration of Popovic,
the apprehension about being cast as 'zealots who are tormenting
this guy,' and a basic disagreement about "standards,' ORI dropped
all charges against Gallo. ORI Director Lyle Bivens went on the
record against the ruling of the Appeals Board (HHS press release
dated 12 November 1993). For instance, as reported in the New
York Times (listed below) the Office of Research Integrity stated
that it was dropping the charges chiefly because the Appeals Board
'now applies different standards from those applied by the Office
of Research Integrity ... ORI maintains that the standards applied
by the panel reflect a fundamental disagreement with ORI as to the
importance of clarity, accuracy, and honesty in science. However,
because ORI is bound by the panel's decisions, it will not continue
its proceeding against Dr. Gallo."
Thus the Appeals
Board never issued a decision on Gallo himself. The ORI dropping
of charges against Gallo was widely reported in the press. I list
a few articles here.
'Misconduct
Charges Dropped Against AIDS Virus Scientist," New York Times,
13 November 1993, p. 1.
"Misconduct finding against Gallo dropped," Chicago Tribune, 13
November 1993, p. 1.
'Case against AIDS scientist dropped," Washington Post,
13 November 1993, p. 1.
"Misconduct charges against Gallo withdrawn after Popovic decision,"
Nature, 18 November 1993, p. 19 1.
"ORI Drops Gallo Case in Legal Dispute,' Science, 19 November 1993,p.1202.
"Victory at Last for a Besieged Virus Hunter," Time, 22 November
1993, p. 61.
The New
York Times and Chicago Tribune articles reported Gallo's statement:
'I am delighted that ORI has dismissed the case against me and that
I have been completely validated.
pg 486
I will now
be able to redouble my efforts in the fight against AIDS and cancer.
There are several avenues of AIDS research that my laboratory is
pursuing.'
In addition
to these news reports, there were supporting articles and editorial
statements, favorable to Gallo, for instance in the Washington Post
and New York Times Gallo himself sent me these pieces (which
I already had), accompanied with a note reading: 'Dear Dr. Lang,
despite your bias, despite your antiscientific self-righteous [sic]
and methods, despite your obsessive need to fulfill hate mongering--nonetheless
I thought your need 'to be involved' should be fulfilled by sending
you information you may have not seen or chose to ignore.' I shall
quote from both these pieces.
Washington
Post editorial: "Dr. Gallo: A Vindication" (1 December 1993). The
Washington Post editorial concluded: 'Dr. Gallo may not be known
for his modesty or retiring nature, but he is, without qualification,
a dedicated and accomplished scientist who has been subject to a
great deal of personal attack.... But it is now clear, even to those
who have doubted it for years, that the problem [of eliminating
AIDS] will not be solved politically.... It is instead a staggering
scientific puzzle whose solution requires the talents and dedication
of the nation's best medical researchers. Dr. Gallo and many others
at NIH are among them.'
New York
Times Magazine: "Method and Madness-- The Vindication of Robert
Gallo," by Nicholas Wade (Sunday, 26 December 1993). The New
York Times Magazine piece, by New York Times science editor
Nicholas Wade, was even more favorable to Gallo. I quote more extensive
excerpts, because I think this piece is very important to document
the New York Times' journalism:
For years,
Gallo has been under a thick cloud of suspicion that he stole from
French scientists the credit for discovering the AIDS virus. The
suspicion has proved groundless.
As a Government Appeals Board concluded last month: "One might anticipate
that from all this evidence, after all the sound and fury, there
would be at least a residue of palpable wrongdoing. This is not
the case."
Not even a residue?
No, and in truth, Gallo's achievement was greater than has been
generally understood, since it far exceeded the mere co-discovery
of the AIDS virus with which he is usually credited....
pg 487
After 12
years, Gallo's blood test is still the only weapon of real value
that scientists have yet managed to devise against this baffling
disease. But far from basking in gratitude, Gallo has been subjected
to years of humiliation. What prompted this cruel twist of fate?
In brief,
a scientific puzzle led to a newspaper attack that triggered an
insatiable government inquiry. The puzzle was that the version
of the AIDS virus Gallo used for his blood test turned out to
have almost the same genetic sequence as Montagnier's virus....
One explanation was that the French virus had gotten loose in
Gallo's lab and overgrown his own virus cultures.... The other
possibility was that Gallo had used the French virus for his experiments
without isolating his own, a physical and intellectual theft.
Given Gallo's competitive nature and his well-known thirst for
recognition, the second possibility loomed large in people's minds.
An unusual
piece of reporting gave the suspicion shape. John Crewdson, a
Chicago Tribune reporter who won a Pulitzer Prize while with the
New York Times, spent 20 months investigating Gallo's work.
His 50,000 word article of Nov. 19, 1989, described several cases
in which colleagues and others believed Gallo had hogged credit
for joint discoveries. Yet the article, despite its author's perseverance,
had several defects.
It was relentlessly
hostile to Gallo, interpreting one complex event after another
to his discredit....
Nonetheless,
the Crewdson article prompted an inquiry by a government office
now known as the Office of Research Integrity.... But in 1991
Gallo and Montagnier solved the festering mystery. The two scientists'
original viruses were indeed different strains, as Gallo had said
all along.... The only evidence for assuming Gallo had appropriated
the French virus promptly evaporated.
But instead
of dropping the case, ORI plodded on. It claimed there were misstatements
in Gallo's discovery papers, particularly in sections written
by his colleague Mikulas Popovic, a Czech virologist. It accused
Gallo and Popovic of 'scientific misconduct,' even while conceding
the alleged misstatement was minor and 'does not invalidate" the
research....
With the
charge against Popovic pulverized, ORI withdrew
pg
488
its case
against Gallo presumably foreseeing it would meet with equal contempt
and whining that the Appeals Board had set a higher standard. In
fact, it was O.R.I. that had proposed a lower one, claiming it only
needed to prove a statement false to establish scientific misconduct,
regardless of intent. Sorry, said the Appeals Board, the regulation
defining scientific misconduct doesn't say 'false." It says "falsification,"
which requires proving an intent to deceive....
In Gallo's rush for the AIDS virus, he bruised many competitors.
His critics mistook his sharp elbows for itchy fingers. They were
far too slow to correct their misjudgment of the one scientific
hero who has yet emerged in the tight against AIDS.
This piece by
Wade was illustrated by a drawing representing Gallo's face as a martyred
saint, halo included.
Readers of
the present book have plenty of documentation from which they can
verify that Wade's piece misrepresents the record of the Gallo-Popovic
case. I don't want to be repetitive, but I shall summarize briefly
a few salient points about that piece.
- Differences
between the Popovic and Gallo cases. Wade's use of the Appeals
Board phrase that there wasn't even "a residue of palpable wrongdoing'
in connection with Gallo is a misrepresentation. Indeed, this phrase
was addressed to the Popovic case, not the Gallo case, which is
completely different in several important respects. For example,
Popovic in a draft manuscript of the Popovic et al. paper had written
two sentences giving credit to the French: 'LAV [the French virus]
as a reference virus ... had been used in the first series of experiments"
and "LAV is described here as HTLV-III.' Gallo struck out both statements
and wrote in the margin, "I just don't believe it. You are absolutely
incredible" and "Mika you are crazy,' as I have explained in detail
in my reply to Gallo. Furthermore Popovic gave the drafts of the
paper with Gallo's marginal notations to his sister in Czechoslovakia,
because he believed that, '... sometime in the future, I might need
them as evidence to prove that I gave fair credit ...' to the Pasteur
scientists. (15 May 1991 Popovic to Hadley memorandum, p. 7.)
The ORI deserves
criticisms for having brought up the Popovic case instead of focusing
entirely on the Gallo case, in light of the very different roles
played by these two scientists. Fred Richards himself made this
point explicit. For instance, Science and Government Report (15
May 1994) states: 'Richards also faulted the OSI Report for focusing
blame on subordinate Popovic, rather than laboratory chief Gallo,
who, Richards said, had the duty to
pg 489
'monitor the
performance of all personnel in the laboratory and to pay particular
attention to the accuracy of major publications which bear his name
as author."
- A 'lower
standard of proof'? The same issue of Science and Government
Report also stated that 'Richards, who testified for the government
in the Popovic misconduct hearing, describes the Appeals Board decision
as 'atrocious,' a view shared by other researchers encountered by
SGR. The Departmental Appeals Board is mainly occupied with
cases concerning Social Security payments and eligibility, and has
virtually no experience or competence in scientific issues...."
- Concerning
Gallo's putative "achievement.' Wade asserted that 'Gallo's achievement
was greater than has been generally understood, since it far exceeded
the mere co-discovery of the AIDS virus with which he is credited.'
In fact, on 11 July 1994, NIH and the Institut Pasteur revised the
agreement concerning royalties for the HIV-antibody blood test,
giving to the 'Institut Pasteur a greater share of the royalties.
Harold Varmus, Director of NIH, stated at the time: "The acknowledgment
of the role of the Institut Pasteur in isolating the AIDS-causing
virus was very slow to occur.' See XVI, §3.
Readers can
also compare Gallo's "achievement" with what is described in the
ORI 'Offer of Proof," which states (p. 47): "The evidence will show
that Dr. Gallo took a cell line identified by another scientist
--'HUT-78'-- and used it to successfully, continuously grow the
AIDS virus, first LAV, then LAV as 'MOV,' then the 'pool' isolate,
'HTLV-IIIb' Dr. Gallo renamed the cell line 'HT,' and when he published
his findings, he misrepresented and obscured the origins of the
cell line so that its true identity could not be discerned. Thereafter,
for a prolonged period, Dr. Gallo failed to diligently seek out
the truth about the origins of 'HT.' Even faced with important evidence
from multiple sources that HT was HUT- 78, Gallo failed to acknowledge
this fact to the scientific community.,
- The patent
application A memorandum of the HHS Office of the Inspector
General (10 June 1994) stated that the patent examiner was unaware
of the extent of the French work at the time she examined Gallo's
patent application, and she said that Gallo should have disclosed
it. Had she known more about the situation with LAV, "she would
have suspended prosecution of the Gallo application and declared
an interference between the two applicants,' that is, the Institut
Pasteur and Gallo. For further direct quotes from the IG memorandum,
see XV.
- Concerning
the reporting by the Chicago Tribune.
pg 490
Comparing the
statements of Crewdson in the Chicago Tribune and the official documents
stemming from ORI, the HHS Inspector General and Fred Richards,
I have not found any false statement or misrepresentation by John
Crewdson in the Chicago Tribune.
'Sharp elbows'
or "itchy fingers'? Nicholas Wade asserts that Gallo's critics
'mistook his sharp elbows for itchy fingers." At some point the
scientific community, let alone readers of the New York Times,
have the responsibility to decide on the available evidence.
Fred Richards is quoted in Science and Government Report ('Advisor
in the Gallo Case Calls for Reopening Probe," 15 May 1994): -Me
major purpose of this whole investigation was to find out whether
they stole the virus. The answer Is, they stole the virus. But we
didn't know that at the time these [investigative] reports came
out." See XVI, §2.
Science
and Government Report. In the article 'Saint or Scoundrel'?
The Gallo Controversy Goes On' (Science and Government Report,
1 February 1994), Dan Greenberg reported various reactions to
ORI's withdrawal of charges in light of the Appeals Board rulings.
The article by Nicholas Wade was mentioned and quoted, as well as
a 'contrary view' contained in a letter to ORI dated 30 December
1993, by Donald P. Francis, who headed the AIDS Laboratory at the
Centers for Disease Control in the early days of AIDS research.
Don Francis had been scheduled by ORI to testify against Gallo (cf.
the "Offer of Proof,' excerpt from page 97 in Appendix 3). Dan Greenberg
quoted from the letter of Don Francis as follows:
From the
letter of Dan Francis to ORI, dated 30 December 1993.
'... the case is a sore in the history of science which
will not disappear. The fact that NIH may not want to proceed is
an internal NIH issue.... But I fear the sore will continue to fester
and will not go away.... The facts of the Gallo case are clear.
Unbiased scientists in the field know what happened. I, because
of my position as head of the CDC's AIDS Laboratory, saw it up close.
In my opinion, Dr. Gallo's behavior was disgraceful, an insult to
the integrity of a scientists. Dr. Gallo purposely tried to rob
the credit for the discovery of HIV- I from the Institut Pasteur.
It was not passive or an oversight.... The stories of Dr. Gallo's
unprofessional behavior go on and on. It is indeed sad. He has contributed
and could contribute to science. But when his ethics are so blatantly
compromised, how can we believe any of his reports? If NIH refuses
to confront these issues, how can we expect junior scientists not
to emulate the Bob Gallo's of the world?'
pg 491
§4.
"The Aftermath of the Gallo Case"
"The Aftermath
of the Gallo Case" was the headline of a 7 January 1994 Science
article by Christopher Anderson, already mentioned in §2. 1
view this article as important in the way it illustrates problems
in journalism (not just scientific journalism), and how the article
pushed one point of view at the expense of others, thus leading
readers in one direction rather than others. Considering the importance
that Science has in the scientific community, I shall devote a separate
section to a detailed analysis of this article.
I have severe
criticisms of this article on several counts. I shall deal only
with a few.
1. The title.
My first criticism concerns the title, which was inappropriate,
because the Gallo case was by no means over. For instance, the investigation
by the HHS Inspector General, and Dingell's investigation, were
still going on.
Independently
of the fact that the Gallo case was not over, the title set the
article specifically in the context of the Gallo case. Furthermore,
the entire article emphasized the legalistic context at the expense
of other contexts for ORI's performance. The subtitle was: 'An appeals
board trounced the federal misconduct office in two recent cases
and said it had misinterpreted its own definition of misconduct;
in future, the office will be more selective in the cases it takes
on.' The article gave weight to so-called 'legal standards' without
mention of scientific standards, as in the sentence: "Most experts
[sic] agree that ... in essence, [ORI] has for years been misconstruing
its own rules.' In light of certain historical facts which I shall
recall, I object to an article which sets 'the aftermath of the
Gallo case' exclusively in such a legalistic context, and I ask
the scientific community to evaluate Science's responsibility in
having pushed the legalistic point of view in such an exclusive
way.
2. "Misconduct
experts" [sic ]. In 'The Aftermath of the Gallo Case,' Science
made repeated mention of 'experts." Near the beginning of the article,
we find (p. 20): "'If I were just an observer, I'd think the scientific
misconduct process is in great disarray,' says Patricia Woolf, a
misconduct expert [sic] at Princeton University, who has been an
advisor to ORI. In an effort to reduce the confusion, Science asked
scientific misconduct experts [sic]--
pg 492
scientists,
university administrators, and lawyers--to assess the impact of
the four cases and their likely effects on future cases." The point
of view of the article is then clearly stated: 'Their almost universal
conclusion: To make a charge of scientific misconduct stick, ORI
will have to meet higher standards of proof than it has applied
in the past.... Most experts [sic] also agree that ORI should have
been applying the standard all along, that in essence it has for
years been misconstruing its own rules.' In the next column, we
read (p. 20): 'The bottom line, according to the experts [sic] Science
consulted, is the emergence of a distinct, two-tiered system for
handling misconduct.' I have already mentioned the reference (p.
22) to 'Rebecca Dresser, a misconduct expert [sic] at the Case Western
Reserve University Law School.'
This repeated
use of the word 'expert provided a backdrop of authority for the
Science article. How legitimate was this backdrop?
Sciences
selection of certain so-called "experts' directed certain conclusions
in certain directions. Another selection of scientists would have
provided other directions.
(a) Goodstein.
Among the so-called expert 'scientists, university administrators,
and lawyers" contacted by Science were Paul Friedman, Dean for Academic
Affairs at the University of California, San Diego, and a member
of ORI's recently disbanded Advisory Board; and David Goodstein,
Vice Provost at Caltech. Anderson included quotes from both of them
as follows:
'If [ORI]
would only have had the sense to go after the clear cases and leave
the crap alone, they wouldn't have had these problems.' [Friedman]
says. Adds Caltech Vice Provost David Goldstein [sic], The panel
did exactly what should be done by holding a high standard. High
legal standards chill investigative zealotry."
I had a high
opinion of Goodstein, based on some previous acquaintances with
some things he was doing, so I was surprised by that quote. I wrote
him a letter dated 1 February 1994 to check with him directly whether
he was correctly quoted, and whether his opinion was based on correct
information. He replied on 9 February that the Science reporter
did 'misquote" him, and explained his position more accurately.6
In particular, Goodstein
Footnotes for page 492
6 I
circulated Goodstein's reply of 9 February to a number of people,
including Science news editor Ellis Rubinstein, to whom I wrote
(24 February 1994):
pg
493
Footnotes
for page 492- Continued
"Under the circumstances, I think it is necessary that a correction
be made in Science. Otherwise the record would stand concerning
a specific way that Goodstein criticized the HHS investigations,
and that record is incorrect.'
Goodstein
subsequently wrote me (25 April 1994): 'My letter to you, dated
February 9th, was a personal one with no cc list. Your act of sending
my letter to Science, without my permission and without consultation,
and demanding on my behalf a retraction from them was, in my view,
a violation of trust sufficiently grave that I am no longer willing
to correspond with you."
Thus
Goodstein raised serious points, typical in file making, and deserving
an answer. I replied on 4 May 1994 addressing myself to these points.
Personal
letters. First, Goodstein's letters to me of 9 February and
25 April were on official Vice Provost stationery. I do not regard
use of Vice Provost stationery, answering publicly raised questions
about the legitimacy of an official quote in Science, as "personal.'
Indeed, on 9 February, Goodstein was answering my letter of 1 February,
which itself was in the context of an open 'file," with cc lists
to all my letters, including my letter to him.
Considering
the fact that Science used his name and position to reinforce a
tendentious point of view in their article, going to their subscription
list of 150,000 and readership of I million, I did not accept to
hold a discussion about this public use of the Caltech Vice Provost
in the context of what he calls a "personal' letter. I hold officials,
especially those quoted as 'misconduct experts,' publicly responsible
for the views they express in an official capacity.
Request
for a correction. Second, I answered that I had not written
on his behalf but on my behalf, as quoted above, that is 'I [sic]
think it is necessary that a correction be made in Science.' By
withholding from my cc list the information that Goodstein gave
a 'rambling explanation,' his insistence that he knew nothing about
the Gallo case, and the more accurate description of his position
that he wrote me, I would become an accessory after the fact to
the misrepresentations in Science.
Journalistic
responsibility. Furthermore, Science held an interview with
Goodstein. They selected quotes from a "rambling explanation," and
printed the quotes in an issue of Science with a subscription list
of 150,000 and a readership of I million. Science did not ask Goodstein's
permission to print their selection. At best they had notes from
the reporter, not even over Goodstein's signature. Colin Norman
wrote to Goodstein that Science stood by these notes (letter dated
7 March 1994).
On
the other hand, my letter to Goodstein of 1 February constituted
a much more careful interview, in which I put four questions to
Goodstein concerning the way he was quoted in Science, and the issues
raised by The Aftermath of the Gallo Case." My letter to him was
in the context of a public challenge to this article. I did my homework,
by not accepting at face value what Science attributed to Goodstein,
as Vice Provost. I checked with the original source. He had my questions
in writing. I did not rely on notes for his reply. I relied on his
full letter over his signature on official Vice Provost stationery.
I claim that my journalism was responsible in a way that Sciences
journalism was not, and I don't understand Goodstein's characterizing
my journalism as a 'violation of trust.'
pg
494
Footnotes
for page 492- Continued
Corresponding
with me. Goodstein wrote me
that he was 'no longer willing to correspond" with me, and that
I 'should not expect to hear' from him again. Of course, it is his
prerogative to hold interviews with Science but not with me, and
he has no responsibility to communicate with me again. However,
he has the public responsibility not only vis-à-vis readers
of Science but on the record, for the quotes Science attributed
to him, modulo the 'corrections and clarifications" published subsequently
by Science, see below.
It
remains for readers to evaluate the way Science, Goodstein, and
I exercised our respective responsibilities, especially our journalistic
responsibilities.
pg 494
wrote me about
the phone interview with Christopher Anderson: "When he asked for
my reaction to what had happened, I told him I had not been following
the Gallo case, knew nothing about it, and had nothing to say about
it.... Before, during and after this discussion [with Science reporter
Christopher Anderson], I insisted I knew nothing about the Gallo
case.' Goodstein also wrote me: 'Surely Anderson was trying to compress
my rambling explanation into one sentence. You can judge for yourself
whether he did it accurately. He certainly had no right to put it
in quotation marks, or imply that it was meant to refer to the Gallo
case.' Anderson did not represent Goodstein accurately. To pass
off an uninformed 'rambling explanation' in the sliver of a quote
reproduced above is not my idea of a proper representation of Goodstein's
position, and constitutes a distortion of Goodstein's uninformed
rambling explanation. Furthermore, adding a sliver of a quote next
to Friedman's 'crap' gave Goodstein's uninformed rambling explanation
a flavor which was Sciences choice. Was it Goodstein's choice?
Science subsequently
printed an item labeled "corrections and clarifications.7
In light of Goodstein's letter to me, I conclude that this item
perpetuated misrepresentations.
Footnotes for page 494
7
[I reproduce in full one of the two items which appeared in Science,
22 April 1994, following the letters to the editor, page 492, under
the heading Corrections and Clarifications.]
In
Christopher Anderson's News & Comments article 'The aftermath
of the Gallo case" (7 Jan., p. 20) the name of David Goodstein,
Caltech vice provost, was spelled incorrectly. Brackets were also
inadvertently omitted around three words in his statement about
the impact on scientific misconduct investigations or recent rulings
by a federal appeals board. The quotation should have read, "The
panel did exactly what should be done by holding a high standard.
[High legal standards] chill investigative zealotry.' Goodstein
was commenting generally on misconduct investigations, not on the
Gallo case.
pg 495
For instance,
Goodstein was quoted as one of several 'misconduct experts" [sic].
Informing readers that Goodstein knew nothing about the Gallo case
(let alone quoting him to this effect) might have made readers question
whether Goodstein rated as an "expert" or not, especially insofar
as he referred to the 'panel' (Appeals Board). However, Science
still withheld from its readers the fact, 'insisted" upon by Goodstein,
that he knew nothing about the Gallo case, and thus still used Goodstein's
quote (whether or not questioned per se) illegitimately. Therefore,
I regard the way Science handled Goodstein's uninformed rambling
remarks, by compressing them into a sharp 'expert" statement without
any indication that these remarks were rambling or uninformed, to
be manipulative, of Goodstein, of the reader, and of the facts.
Despite the
added comment that "Goodstein was commenting generally on misconduct
investigations, not on the Gallo case,' the Goodstein quote stood
as saying: 'The panel did exactly what should be done by holding
a high standard. [High legal standards] chill investigative zealotry."
At this point, I shall not reproduce the longer explanations which
Goodstein wrote me on 9 February. Absent any further statement from
Goodstein, he is responsible on the record in Science for comments
supporting 'the panel,' I.e., the HHS Appeals Board, at the expense
of ORI. The combination of quotes from Friedman and Goodstein reinforced
the overall point of view of the Science article, which was to support
a legalistic point of view, and to discredit the efforts (however
clumsy and partly incompetent) of ORI, and the Richards Panel, to
get at the truth.8
(b) Selectivity
of the "experts." The "expert' scientists contacted by Science
did not include scientists who, in various ways, had reservations
about the Appeals Board decision. I list some such scientists.
- Fred Richards
explicitly expressed a point of view shortly after the Appeals Board
ruling on Popovic: "For the kind of things we're dealing with in
Gallo, the lawyers have no business being here at all.
Footnotes for page 495
8
I find it appropriate here to
recall the statement on Scientific Conduct issued by the Councils
of the National Academy and Institute of Medicine, and the Executive
Committee of the National Academy of Engineering, 2 February 1994,
containing the sentence: 'As members of the Professional research
community, we should strive to develop and uphold standards that
are broader than those addressed by the government regulatory and
legal framework for dealing with misconduct in science.'[Underlining
in the original]
pg 496
They're not
going to contribute anything except exacerbation. The scientific
community is perfectly capable of handling these things itself.
We have done so for years.' ('U.S. may not fight appeal by Gallo,"
Chicago Tribune, 10 November 1993, p. 1.)
- Priscilla
Schaffer, a professor at the Harvard Medical School, was quoted
in the Chicago Tribune immediately following Fred Richards: 'Many
of the conclusions that this board of non-scientists reached were
really unscientific.' According to the Chicago Tribune, Priscilla
Schaffer 'testified for the government against Popovic and was scheduled
to testify against Gallo.'
- Donald P.
Francis was quoted as mentioned above in Science and Government
Report (1 February 1994).
- John Edsall
(I know also of three others) wrote to Dingell: "I believe that
the standards of ethical conduct for scientists are, and should
be, more demanding than the purely legal ones.' Edsall concluded
his letter to Dingell by observing that "the attempt to clear Dr.
Gallo of all legal charges against him is on the verge of complete
success. If you have strong evidence that could lead to a different
conclusion, would not this be the time to make it public, in the
interest of truth and honesty, and perhaps also of appropriate legal
action?" (Quoted in Science and Government Report, 15 March 1994,
"With Gallo Exoneration Looming, Dingell Asked to Act,' p. 3.)
No scientist's
point of view remotely related to any of these was mentioned in
the Science article 'The Aftermath of the Gallo Case' (or the subsequent
ScienceScope article, see below). The three pages of "The
Aftermath of the Gallo Case' in Science were devoted to placing
the Gallo case in the context of "American legal standards,' as
a Science editor Colin Norman wrote to Goodstein in a letter dated
7 March 1994. The legalistic context deemed worthy of three pages
by Science completely left out a point of view of some scientists
that a legalistic approach to cases such as those of Gallo (and
Baltimore previously) is undesirable, or whatever expressions various
scientists would use. Each one has their own way of formulating
their point of view. In particular, Paul Doty, who went public in
the context of the Baltimore case, warned that science "risks sliding
down toward the standards of some other professions where the validity
of action is decided by whether one can get away with it. For science
to drift toward such a course would be fatal...' (Nature, 18 July
199 1, p. 183). The Science article "The Aftermath of the Gallo
Case' provides documentation of such a slide, not just the 'risk"
of such a slide. Paul Doty was not one of the "misconduct experts"
mentioned by Science. The bottom line is that the 3-pages long Science
article 'The Aftermath
of the Gallo Case'
pg 497
pushed the
point of view of legal standards at the expense of other standards,
e.g., scientific standards.
Also not mentioned
were Suzanne Hadley, nor anyone on Dingell's staff, nor anyone from
the HHS Inspector General's office, let alone mentioned as "experts."
However:
- Suzanne Hadley
is an extraordinarily well-informed person, because she originally
directed the Gallo investigation until she was "reined in"-_i.e.,
forced out-by Bernadine Healy. Then until 15 April 1994, she was
on detail from HHS to advise the Dingell Subcommittee on Oversight
and Investigation about the facts of the case and about documentation
which could be available in the files of NIH. By placing 'The Aftermath
of the Gallo Case" in the context of American legal standards,"
at the expense of a context whereby Science would recall the history
of the Gallo case, including the "reining in" of Suzanne Hadley
by NIH Director Healy (Science, 26 July 1992, p. 372) represented
a definite choice of one point of view over another.
- Dingell's
opening statement at the hearings of 21 July 1993 brought up the
possibility that HHS officials "suppressed evidence" for the patent
application of the HIV blood test, and that his investigation encountered
"repeated instances of obfuscation and obstructionism on the part
of past and current Government officials.... Documents have been
destroyed. Documents have been withheld for protracted periods.
In several instances, key documents known to exist have never been
produced from the official files...."
- The HHS Inspector
General was still to be heard from, and we she deal with the Inspector
General later.
I object to
Sciences selectivity of 'experts," which resulted in leaving out
of Sciences article important material and informed points of view
which could have been provided by scientists such as those mentioned
above, as well as by Suzanne Hadley, Dingell, or the HHS Inspector
General.
3. No historical
context of the Richards Panel. Nowhere in "The Aftermath of
the Gallo Case" (and a subsequent ScienceScope piece) did
Science recall the origins of the Richards Panel, namely
the solicitation in 1990 by HHS and NIH to the NAS "to nominate
a slate of qualified observers to verify the independence and thoroughness
of the NIH's own investigation," as reported by Barbara Culliton
in Science, 23 February 1990. Culliton wrote further, "We
decided to go the 'extra mile' for the NIH's sake and for Dr. Gallo's".
Raub told Science " . . . .Press and Thier [President of
the NAS Institute of Medicine]
pg 498
have agreed
to propose such a panel with the stipulation that Mason confine
his selection to that list and agree not to add anyone recommended
by the government, which can be said to have a stake in the outcome
because It is a signatory to the U.S.-French agreement...." Thus
the commitment of HHS-NIH to the NAS was not legalistic but scientific,
directed toward "independence and thoroughness," not toward a dependency
on "American legal standards."
Did Science
contact members of the Richards panel for the article? If Science
did not, It was a serious omission. If Science did contact
members of the Richards Panel, and they refused to issue a statement,
this fact deserved to be reported in light of previous commitments
by the Richards Panel to "speak out loud and clear," as reported
by Science itself when Barbara Culliton wrote: "Sources say
committee members have promised not to discuss their deliberations
until they are complete. At that point, they expect to ‘speak out
loud and clear’." ("Inside the Gallo probe—The Committees," Science
22 June 1990).
I also recall
here that Gallo himself was quoted in the Culliton Science 23
February 1990 article, as supporting "the decision to name outside
advisers." "I welcome this," he told Science. "These allegations
have been going on too long. I have done nothing wrong and I have
no apprehension or anxiety about the review. And, I’m confident
that the only chance I have is the help of independent colleagues."
These colleagues came to the conclusion that there was "a pattern
of behavior on Dr. Gab’s part that repeatedly misrepresents, suppresses,
and distorts data and their Interpretation in such a way as to enhance
Dr. Gallo's claim to priority and primacy.... Given the quality
of the Information derived from propagation of the French virus,
we believe that this constitutes intellectual recklessness of a
high degree-in essence, intellectual appropriation of the
French viral Isolate."
Thus Gallo's
"only chance" ultimately was not "the help of independent colleagues"
but lawyers and what some people call "legal standards."
However, in
its "Aftermath of the Gallo Case" and the subsequent ScienceScope
article, Science did not place current events and the
rebuff of ORI (and subsequently of the HHS Inspector General) by
the legal system In the historical context recalled above. Science
did not deal with the significance of the complete breakdown
of the commitments made in 1990 by NIH-HHS, as well as the commitment
by the Richards Panel "to speak out loud and clear." Such a breakdown
of commitments Is certainly part of the Gallo case, and will be
part of Its aftermath, but Science chose
pg 499
to report matters
In an entirely different context, favorable to the legal system
and insulting to ORI ("leave the crap alone," " [High legal standards]
chill investigative zealotry").
Therefore I
call Sciences journalism tendentious, and I object.
4. Limited
hangout in the "Corrections and Clarifications." From January
to April 1994, I communicated my objections described In this section
concerning "The Aftermath of the Gallo Case" to Science news
editor Ellis Rubinstein. In light of these objections, I regard
the "corrections and clarifications" (reproduced in footnote 6)
as a limited hangout. For example, Ellis Rubinstein had written
to me (letter dated 19 January 1994): "Nevertheless I think you
have a point about our headline over our 7 January story: it probably
implies more than it should. For that, you should not blame Chris
[Anderson] but his editors. While some institutions choose never
to concede error of any sort, the Science staff attempts
to hold itself to a higher standard." No mention of the defective
title was made in the "correction and clarification." Even more
importantly, the correction or clarification did not address the
deeper objections transcending specific misrepresentations of Goodstein,
namely that the whole context of "misconduct experts" was illegitimate
and was used to push certain points of view at the expense of others.
Ellis Rubinstein
also wrote me on 6 April 1994: "I have admitted failings on our
part—not of course sufficiently to satisfy you—and upon occasion
have left open the possibility that we erred more than we realize."
There is no indication of any further errors In the "corrections
and clarifications" printed In the Science issue of 22 April
1994, and Rubinstein did not answer my request for a list of i |