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The
Gallo Case - Part 2 Part
1 Part 3 Part
4 Part
5
Part
2 - Contents
VI. ABUSE OF THE RICHARDS PANEL
BY NIH pp 409-419
VII. THE INTEGRITY
OF SCIENTIFIC CONSULTATION pp 420-438
VIII.
INTERLUDE: JOURNALISTIC
OBSTRUCTIONS pp 439-441
IX. AN EXCHANGE WITH GALLO pp
442-466
Note: Page numbers refer
to corresponding pages in the paperback edition of the book "Challenges"
VI.
ABUSE OF THE RICHARDS PANEL BY NIH
We now return
to the role of the Richards Panel in the OSI Report. I have a number
of criticisms involving this panel:
- The panel
did not "oversee" the investigation, and did not do the necessary
gumshoe work to find out about material which NIH withheld from
its considerations.
- The panel accepted to work under conditions of "'confidentiality."
A "Confidentiality Agreement" which these members accepted
to sign is reproduced in full as an illustration in the next part.
- The panel was abused by NIH, and especially by NIH Director
Bernadine Healy, who undermined the integrity of scientific consultation.
Healy obtained
the panel's views by asking the members to return a questionnaire
concerning the investigation. The first question was: "Does the
report show that the investigative process was thorough and pursued
the issues appropriately'?" This question fits under the first item
which I criticize above. The panel's answer was: 'We believe that
the collection of physical evidence, the investigation of the facts,
and the interviews of the witnesses were thorough and appropriate.
However, we believe that certain of the analyses and conclusions
of these investigations are flawed. The problems are discussed below."
Of course, I have no direct information about the collection of
physical evidence, the investigation of the facts, and the interviews
of witnesses. But the critique by Suzanne Hadley of the "draft"
report gives indications that all three were insufficient and that
documentation available to NIH was withheld from the Richards Panel.
Short of contacting Suzanne Hadley herself or outside sources such
as the Dingell Committee, there was no way the panel could know
what material was withheld from its considerations.
In answer to
a second question by Healy: "Are the issues/ allegations stated
properly in the proposed final report?," the
pg 410
panel answered:
"Yes. This aspect of the Report represents a very good job."
However, Crewdson's documentation concerning possibly false statements
by Gallo in his patent application was not dealt with in the OSI
Report. Nevertheless, the panel answered "yes" to the third question
whether "the proposed final report addressed all the issues
that should be addressed."
On the other
hand, the panel answered "no" to the question whether "all
of the issues were appropriately covered." It stated:"'Each
of the allegations raised against the Popovic et al. paper is considered
independently in the Report and in no obvious or stated order of
priority. This tends to trivialize the significance of the findings.
The Conclusion section castigates the overall level of accuracy
of the paper, but fails 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."
The panel then went on to detail a list of events which document
such a pattern. I cite one of them to give the scientific flavor
of the Richards Panel answer:
A. LAV (LAI)
was grown successfully in the Gallo laboratory during the fall of
1983. In particular, LAV was successfully propagated using HUT78
cells. Thus, a crucial fact was established-HUT78 cells were permissive
for the growth of LAV (i.e. the causative agent of AIDS). The Gallo
lab "went to school" with the French virus, yet they
later failed to mention the fact that they had propagated the French
virus. In fact, they denied propagation of the French virus and
stated (in the Popovic et al. manuscript) that the French virus
had never been transmitted to a permanent cell line. 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.
The conclusions
of 'intellectual recklessness of a high degree" and "intellectual
appropriation" are remarkable. This was the first time any
"official" body said any such thing.
I was especially
concerned with the role played by the National Academy of Sciences.
After its top officials nominated the panel, they subsequently evaded
the responsibility to insure the integrity of scientific consultation,
as illustrated in the following exchange of letters. I first wrote
to the Council of the Academy on 5 April 1992, concerning Gallo's
election in 1988.
pg 411
My Letter
to the NAS Council
To the Council
National Academy of Sciences
2101 Constitution Ave.
Washington, DC 20418
Robert Gallo
was elected to the National Academy of Sciences in 1988. John Crewdson's
book-length article in the Chicago Tribune of 19 November
1989 started nationally a long train of questioning of scientific
practices by Gallo. Following a request by NIH, the Academy "developed
a list of nominees to oversee the review by the National Institutes
of Health of the circumstances leading to the discovery of the AIDS
virus and the allegations about the research practices of Dr. Robert
Gallo." [Letter from Frank Press to James Mason, Assistant Secretary
of Health 13 March 1990.1 The panel thus nominated
by the Academy was chaired by Fred Richards.
The latest
article by Crewdson in the Chicago Tribune of 27 March 1992
quotes extensively from a report by the Richards Panel to NIH. I
reproduce here some paragraphs from Crewdson's article:
In her charge
to the panel members, Healy asked for their opinion on whether the
NIH report represented "an appropriate, thorough, and credible
investigation of the charges" against Gallo. In several
important respects, the panel said, it did not.
The NIH
report is not uncritical of Gallo whom it accuses of "an
unhealthy disregard for accepted standards of professional and
scientific ethics." The panel, however, faults the NIH for
failing to present its findings in a "larger context."
To have done
so, it says, would have demonstrated "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."
... Popovic
told NIH investigators that his initial draft of the 1984 article
included the acknowledgment that he had grown and performed experiments
with the French virus, and had used it as a "reference virus"
in later experiments.
But Popovic
said that, despite his insistence on giving credit to the French,
Gallo deleted his acknowledgments
pg 412
from the manuscript with the written comments: "Mika, are you
crazy?" and "Mika, you are incredible." Popovic is known
to friends as Mika.
... The published Science article declared that the French virus "has
not yet been transmitted to a permanently growing cell line for true
isolation"-precisely the experiment, the NIH investigation found,
that Popovic had performed successfully several months before.
The NIH report nevertheless accepted Gallo's claim that he had not
intended to conceal his work with the French virus. The questioned
statement, he said, had referred not to work in his own laboratory
but to what he then believed was the inability of the Pasteur scientists
to grow their own virus.
According to the panel, however, Gallo's statement was indicative
of "a pattern of misrepresentation" in the description of the isolation
of the AIDS virus in the Science article.
'"The statement," the panel wrote, "was simply false and
was known to be false at the time the paper was written" and represented
"one of the most glaring faults in the paper." The panel concluded
that "there is no way in which Dr. Gallo can be excused from
sharing the blame for this misstatement."
Not only did Gallo's failure to acknowledge his work with the French
virus represent "intellectual recklessness of a high degree,"
the panel said, it amounted to the "intellectual appropriation of
the French viral isolate...."
Gallo's nomination
and support for election to the NAS in 1988 was based in large part
on his purported contributions to discoveries concerning the AIDS
virus. The information that has since come out publicly (but there
are indications that it was previously known to some researchers
in his field) strongly indicates that Gallo was nominated and elected
to the Academy under a questionable representation of his work.
Therefore,
both as a member of the NAS and a member of the scientific community
at large, I ask the Council to start a public investigation of the
merits of Gallo's nomination and election, because the National
Academy of Sciences is responsible and accountable to the scientific
community at large for its standards, as well as for promoting standards
and setting examples of standards. Membership in the NAS is taken
seriously by some people, who see it as bestowing scientific credibility
and certifying scientific
pg 413
achievement.
I am aware that the bylaws of the Academy do not have provisions
for the resignation of someone from the Academy. But the question
whether anyone-Gallo in the present instance-is to resign from the
Academy is not the only question that needs to be addressed, nor
in my opinion is it such an important one. The Academy could very
well clear itself by admitting publicly to having been misled (it
remains to be determined by whom and how), without taking the statutory
step of forcing Gallo's resignation.
Sincerely yours,
Serge Lang
cc: John Crewdson,
Robert Gallo, Fred Richards, Edward David - COSEPUP Panel, Gérard
Debreu (Chair, Social Science Class of the NAS), etc.
Enclosure:
Crewdson's article of 27 March 1992.
In a PS to
this letter, I recalled the open letter by John Cairns to an officer
of the NAS, published in Nature (I I July 1991, p. 101).
Excerpts from this letter are reproduced in the chapter on the Baltimore
case, which was the original context of the letter. Here in the
context of the Gallo case, I reminded the Council that I wrote to
the Council on 25 February 1990 objecting to Gallo's election even
at that time. I deplored how "the natural tendency of the higher-ups
in the NAS has been toward secrecy, looking the other way, taking
the limited hang-out route, refusing internal, let alone public
discussion about certain issues.... The Council of the Academy and
the Academy itself, have to make a choice as to the leadership they
will provide. The history of the past two years shows that the Academy's
failure of responsibility is continuing exactly as I described it
in 1990."
Other NAS-Related
Correspondence
I received
a terse reply dated 8 May 1992, from the NAS Home Secretary Peter
Raven. He informed me that the Council discussed my letter concerning
Gallo, and asserted: "The Academy will not 'undertake a public investigation
of the merits of Gallo's nomination and election' as you requested.'
A month later,
on 4 May 1992, I wrote directly to Frank Press, President of the
NAS:
pg 414
Dear Dr. Press,
1. On 15 February 1990, the HI-FS Assistant Secretary James Mason
wrote you:
As you know,
an article published this past November in the Chicago Tribune made
a number of allegations about the research practices of Dr. Robert
Gallo.... In accordance with its normal procedures, the NIH now
is engaged in an inquiry to determine what, if any, significance
the charges might have.... With a view to insuring both the fact
and appearance of objectivity for the inquiry [sic], Dr. William
Raub, the Acting Director, NIH, has asked me to solicit the assistance
of the National Academy of Sciences (NAS) in nominating candidates
for a special advisory panel ... to make informed, unbiased judgments
[sic] about the issues raised in the Chicago Tribune article.
You agreed
to cooperate with NIH and HHS in this matter, and accordingly you
wrote to James Mason on 13 March 1990 to nominate the members of
such a panel,
to oversee
the review by the National Institutes of Health of the circumstances
leading to the discovery of the AIDS virus and the allegations about
the research practices of Dr. Robert Gallo.
In his press
conference of 5 October 1990, NIH Acting Director William Raub made
use of the prestige of the NAS by stating: "The consultants nominated
by the National Academy of Sciences and the Institute of Medicine
will continue to provide oversight and guidance as they did during
the inquiry.l
Now, two years
later, as reported by Crewdson in the Chicago Tribune of 27 March
1992, we learned that the Richards Panel had indeed issued its judgment
of the NIH inquiry and of Gallo's practices, and that this judgment
was unfavorable. As quoted by Crewdson, the Richards Panel blamed
the NIH report for not presenting its findings "in a larger context'
which would show 'a pattern of behavior on Dr. Gallo's part that
repeatedly misrepresents,
1
Incidentally,
I was very critical at the time of what was said at this press conference
and the way the Richards panel approved what was said, but this
is another issue.
pg 415
suppresses,
and distorts data and their interpretation in such a way as to enhance
Dr. Gallo's claim to priority . . . intellectual recklessness of
a high degree . . .intellectual appropriation of the French viral
isolate . . .
However, NIH
and HHS decided not to accept the judgment of the Richards Panel.
In an article headlined 'NIH Vindicates Researcher Gallo in AIDS
Virus Dispute" (Washington Post 26 April 1992), Malcolm Gladwell
wrote: 'In making her decision to approve the Gallo report without
major changes, [NIH Director] Healy considered-but ultimately did
not accept-the advice of a panel of outside consultants who said
the report was too mild in its criticisms of Gallo.' Gladwell also
casts aspersions on the judgments of the Richards Panel. Thus NIH
and HHS throw down the gauntlet via the press. At the same time
neither the NIH Gallo Report nor the Richards Panel Report have
been made officially public even though they are available to some
reporters!
The current
scenario involving the NAS, NIH, HHS, and the Fred Richards Panel
is worthy of Kafka and Ionesco.
2. NIH
and HHS have been less concerned with the integrity of science than
with leaks of the NIH investigation, leaks of the Richards Panel
report, covering up and muzzling scientists. Indeed:
(a)
Dan Greenberg's Science and Government Report of I April 1992 states:
Despite Healy's
campaign against leaks from OSI, the place still leaks, often to
the Chicago Tribune, whose Pulitzer Prize reporter John Crewdson
has led the journalistic field in coverage of the long-running controversy
concerning Robert Gallo's role in the identification of the AIDS
virus. All this despite changing OSI's locks, engagement of a security
officer, and other anti-leak steps.
Apparently obsessed by the leaks, Healy unsuccessfully tried to
enlist the gumshoe services of the Inspector General of the Department
of Health and Human Services. IGs, however, are not always hostile
to leakers.
Healy then turned to the FBI, writing on March 10 to an agent
in the FBI's Silver Spring, Md., office an emotionally souped-up
letter prophesying the demise of NIH and government supported biomedical
and behavioral research if the leaks are not scaled....
Healy's appeal
to the FBI was likewise mentioned in Crewdson's article of 27 March
1992 and in Science (Official Doubt on the AIDS Test Patent,
3 April 1992),
pg 416
both quoting
Healy's letter to the FBI agent, to the effect that the leaks have
demonstrably
damaged the credibility of the U.S. governments position on patent
and other related business matters ... [the damage caused by the
leaks was] substantial and likely in the millions of dollars.
(b)
Another Science article (The Richards Panel Tosses a Curve, 3
April 1992) states:
Members of
the panel contacted by Science declined to discuss their report,
privately expressing their frustration with a confidentiality agreement
they were forced to sign by NIH.
Thus we find
scientific and intellectual corruption against a backdrop of financial
concerns at the highest levels of the science establishment. As
far as I am concerned, the NIH and HHS have discredited themselves
by their cover up and their muzzling of the panel nominated by the
NAS.
Thus we also
find scientists accepting to "oversee' under conditions of confidentiality
instead of refusing to do so because of their responsibility and
accountability to the scientific community at large. Since the NAS
was solicited publicly by NIH to oversee the Gallo investigation,
and the NAS accepted publicly, the NAS and the Richards Panel are
now accessories after the fact unless they act publicly to the contrary.
Unless the NAS and the members of the Richards Panel publicly object
to the way they were used and abused by NIH, they will also discredit
themselves.
3. The breach
of trust by NIH-HHS vis-à-vis the NAS, the tacit acceptance
of this state of affairs (so far) by the NAS and the Richards Panel,
and the behavior of NIH-HHS toward those scientists who try to bring
truth to the public, constitute a profound breakdown in the standards
and credibility of the scientific establishment. As a scientist,
as a member of the NAS, as a member of the academic community, and
as a citizen, I wish to record here my unmitigated disgust.
Serge Lang
cc: Fred Richards,
John Crewdson, Dan Greenberg, John Dingell, etc.
pg 417
Frank Press
replied officially in his capacity as NAS President, on 7
May 1992: 'I have your letter in which you register unmitigated
disgust with the Gallo investigation and the role of NIH-HHS and
the NAS. It was clear to both the NIH and to the Academy that our
role in the matter was to provide to NSF [sic) names of reputable
scientists qualified to serve in an advisory role. Regardless of
what individuals have stated publicly, it was clear to NIH and to
the Academy that this was to be an exclusively NIH committee with
no further role for the Academy than to suggest names. We have served
in the role of identifying experts on numerous occasions for many
organizations, both public and private.'
I wrote
back on 14 May 1992: 'This is to acknowledge receipt
of your letter of 7 May 1992, which to me is verbiage. I do not
understand the relevance of your phrases starting with 'it was clear...,'
and I wonder about their role in your letter. There is an innuendo
in those sentences that somehow I am not representing the situation
properly in my own letter. However, what 'was clear' to whoever
is irrelevant, and I object being put in a position of having to
consider what 'was clear to both the NIH and to the Academy.' I
commented on the record as it exists, not as people might rewrite
it. In my letter to you I quoted correctly and in context from the
exchange you had with James Mason, and I quoted correctly and in
context from Raub's press conference. I therefore stuck to the record
and I ask others to evaluate those concerned on the basis of this
record. I hold people involved in this record responsible and accountable
for their actions. I stand by what I wrote.'
These exchanges
document the way top officials of the NAS evaded taking responsibility
for supporting the panel which they had nominated.
Opinions in
the Academy are of course not monolithic, and I have no idea how
many people share my viewpoint. Some members of the NAS wrote in
support of the point of view expressed in some of my mailings, e.g.
Jack Steinberger wrote to me to express '100% support', and Philip
Siekevitz wrote to Frank Press (9 September 1992): "... the members
of the committee selected by the NAS and the IOM were used by the
NIH, indeed were misused. In your correspondence with Dr. James
Mason, you point out that the group selected was not an 'NAS group'
and should not be identified as such. However, I do not think you
can get the NAS off the hook completely. Since the NAS did the selection,
it should back up the members of the group, it should not dismiss
its responsibility to the members of the group in its battle with
the NIH. I think that an honorable duty would be that the NAS
pg 418
castigates
publicly, how its members were treated, demand an apology from the
NIH for its dismissal of the findings of the members selected by
the NAS re the 'Gallo Affair.'
For one member of the Academy who does not agree, I mention
Freeman Dyson. In his article 'Science in Trouble" (American Scholar,
62, 1993, pp. 513-525), he wrote:
The personal
behavior of scientists is taken very seriously by our official guardians,
the National Academy of Sciences and the departments of government
concerned with the funding of science. At a meeting of scientists
at Princeton some years ago, various functionaries from the Washington
office of the National Academy of Sciences spoke. One of them talked
like a Grand Inquisitor. She said her mission was to stamp our Deviant
Science. I disagreed sharply with her. I do not find it shocking
that some of our best scientists turn out to be cheats or crooks.
Creative people in any walk of life have a tendency to be odd. To
stamp out Deviant Science means to drive out odd people from our
profession. Scientists should be subject to the same laws as other
citizens so far as criminal behavior is concerned. It is a fundamental
mistake to pretend that scientists are more virtuous than other
people or to attempt the enforcement of virtue by means of an Academy
inquisition.
I was recently invited by the Academy to serve on a committee to
investigate the alleged violation of ethical standards by the biologist
Robert Gallo. The president of the Academy informed me that service
on the committee was an important public duty. Nevertheless, I declined.
I did not wish to be a part of any such inquisition. Robert Gallo
is a scientific entrepreneur who has made enormous contributions
to the understanding of the AIDS virus. The position of Robert Gallo
in the world of biology is like the position that Robert Oppenheimer
occupied forty years ago in the world of physics. The two Roberts
were both successful scientific empire builders. They both ran big
organizations with brilliant flair and with some disregard for bureaucratic
rules. They were both accused of deviousness and occasional dishonesty....
The proceedings against Gallo have the same vindictive character
as the proceedings against Oppenheirner. Our National Academy of
Sciences is now lending its name to such proceedings in the same
way as the Atomic Energy Commission did in 1954. In both cases,
a great man is being harassed and punished for offenses that
are, in comparison with his achievements and his services to society,
trivial
pg 419
I am amazed
by Dyson's statements on several counts. First, the Home Secretary
had categorically written to me that the Academy would not undertake
a 'public investigation' of the merits of Gallo's election, as I
requested. Two letters from me to Dyson asking for more information
about the NAS Committee remained unanswered. My experience with
the NAS was the opposite of Dyson's: publicly, the Academy totally
kept from taking any responsibility in the Gallo case, as documented
above. Upon checking with a staff member of the Academy, I was told
that Dyson's reference, as far as this staff member knew, was to
the Richards Panel, and that Dyson gave a misleading impression
with his sentence: 'I was recently invited by the Academy to serve
on a committee to investigate the alleged violation of ethical standards
by the biologist Robert Gallo.' Nevertheless, I don't know of any
public, on the record correction to the Dyson article, either by
him or by the Academy.
Second, I find
Dyson's comparison between the Gallo and Oppenheirner cases to be
flabbergasting from a historical point of view. Both cases are sufficiently
famous so that I win leave to others their evaluation of Dyson's
comparison, without any further comment here. I merely want to mention
one important case of a famous member of the NAS who holds opinions
quite divergent from mine.
VII.
THE INTEGRITY OF SCIENTIFIC CONSULTATION
I thought
the responsibility of the NAS was to play an active role in maintaining
the integrity of scientific consultation to the government. Having
failed to arouse the interest of top officials of the NAS, I contacted
the Section Chairs by writing to them directly. I never received
an answer from any of them to the following letter dated I September
1992. The letter was accompanied by 40 pages of enclosures, giving
primary sources for my assertions, and listed at the end o the letter.
To all Section
Chairs
National Academy of Sciences
NIH investigated
the Gallo case as a result of John Crewdson's major journalistic
contribution in the Chicago Tribune of November 1989. NIH and HHS
involved the NAS by soliciting the nomination of a panel of independent
consultants to enhance the credibility of the Investigation. However,
NIH and HHS subsequently betrayed their commitment to the panel
and to the NAS. I shall therefore deal here with a major issue,
which arose in the Gallo case, but transcends the Gallo case, namely:
The integrity of scientific consultation for the government is
at stake,1 especially concerning
the involvement of the National Academy of Sciences.
Footnotes for page 420
1
Also
at stake is the integrity and credibility of NIH and HHS. There
is evidence that NIH misrepresented certain facts and suppressed
evidence unfavorable to Gallo, both in the Final Report from Its
Office of Scientific Integrity (OSI) and in the cover letter by
NIH Director Bernadine Healy forwarding the report to James Mason.
The article on the OSI Final Report in Chemical and Engineering
News (11 May 1992) gave some evidence to this effect, and
was accompanied by a boxed boldfaced editorial comment: 'Report
raises questions as to whether NIH, HHS can objectively investigate
prominent scientists.' (Copy enclosed.)
Dan
Greenberg in Science and Government Report I June 1992, quotes
excerpts from a 'dissent and critique" prepared for the Dingell
Committee (copy enclosed). Some conclusions from these excerpts
state: 'The Office of Scientific Integrity (OSI) 'Final Report'
concerning Dr. Robert Gallo's research on the AIDS virus is a
deeply flawed document reflecting an incomplete investigation. .
. . A number of the 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. . . ."
However,
in the present letter I concentrate on the issue of respective responsibilities
between the NAS, NIH-HHS, and the Richards Panel nominated by the
NAS to "oversee" the NIH investigation.
pg 421
I am addressing
this mailing to you for direct action on your part at the grass
roots.
Responsibility
of the NAS via HHS and NIH. On 15 February 1990, HHS Assistant
Secretary James Mason wrote to Frank Press (President of the National
Academy of Sciences): 'With a view to insuring both the fact and
appearance of objectivity by the inquiry, Dr. William Raub, the
Acting Director, NIH, has asked me to solicit the assistance of
the National Academy of Sciences (NAS) in nominating candidates
for a special advisory panel ... to make informed, unbiased judgments
about the issues raised in the Chicago Tribune article.' Frank Press
and Samuel 0. Thier (President of the NAS Institute of Medicine)
agreed to nominate the members of such a panel "to oversee the review
by the National Institutes of Health of the circumstances leading
to the discovery of the AIDS virus and the allegations about the
research practices of Dr. Robert Gallo.'
Betrayal
of commitment to the NAS. The subsequent history shows that
HHS and NIH betrayed their commitment to the NAS (and to the scientific
community at large) in several ways, among which:
- NIH extracted
a 'Confidentiality Agreement" from the members of the Richards Panel,
thus muzzling these consultants.
- NIH operated in such a way that the Richards Panel could not "oversee"
the investigation, as specified by Frank Press and Samuel 0. Thier.
- NIH withheld information from the OSI Report on which the Richards
Panel was asked to comment.
pg 422
- NIH Director
Healy used other consultants of her own choosing to override the
Richards Panel.
- NIH Director Healy undermined the Richards Panel in the press.
- NIH Director Healy distorted and improperly represented the views
and reports of the Richards Panel members.
In an appendix,
I shall provide detailed documentation on these items, showing how
seriously the integrity of scientific consultation was compromised.
However, I mention one aspect of the Confidentiality Agreement here
because it involves the NAS specifically. The Agreement concludes
with the sentence:
I understand
that in the event an investigation establishes a failure on my part
to comply with the terms of this agreement, NIH may pursue such
actions as are legally available to them, including, but not limited
to, taking such failure into account in making future hiring or
appointment decisions, and reporting such failure to the National
Academy of Sciences.
The invocation
of the NAS in this Confidentiality Agreement ("reporting such failure
to the National Academy of Sciences") makes the NAS an accessory
to the fact by implication. It is now incumbent on the NAS either
to take direct responsibility for the Confidentiality Agreement
or to repudiate this Agreement and the way the NAS was invoked in
this Agreement.
pg
423
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CONFIDENTIALITY AGREEMENT
I understand
that the Office of Scientific Integrity's (OSI) proposed final
re- port of the investigation into possible misconduct by
Dr. Gallo and Dr. Popovic is being made available to me for
the limited purpose of review and consent so that I may provide
individual advice to the OSI and the National Institutes of
Health (NIH).
I agree,
as a condition of my consulting relationship with the NIH,
to observe strict confidentiality with respect to the proposed
final report, the information contained in it, and all information
I obtain as a result of any meetings to discuss the proposed
final report. Specifically, I agree to the following conditions
to ensure such confidentiality: (1) While the proposed final
report is in my possession, I will not disclose it to anyone
and will safeguard it so that it will not be inadvertently
disclosed to anyone; (2) I will not make any copies of the
proposed final report; and at the conclusion of the review
session for which a copy of the proposed final report has
been made available to me, I will immediately return to the
NIH the copy of the draft report made available to me and
all notes or other written documents that I have made that
refer to the proposed final report or any discussion of it;
(3) I will not talk to anyone, other than authorized representatives
of the OSI and NIH, about the pro- posed final report or the
review session; (4) If I am contacted by a representative
of the news media, I will immediately refer that individual
to the NIH Office of Communications without disclosing or
acknowledging any information about the proposed final report
or the review session; and (5) I will cooperate fully with
any government investigation of any unauthorized disclosure
of the proposed final report. Notwithstanding the preceding
sentences in this paragraph nothing contained herein shall
bind the signer to refrain from commenting on the final report
of this investigation, if and when it is publicly released
in an authorized manner.
I understand
that in the event an investigation establishes a failure on
my part to comply with the terms of this agreement, NIH may
pursue such actions as are legally available to it, including,
but not limited to taking such failure into account in making
future hiring or appointment decisions and reporting such
failure to the National Academy of Sciences.
DATED:
_____________________________________
SIGNED: ______________________________________
The Confidentiality
Agreement above was signed on 30 January 1992 by six members
of the panel. Judith Areen, Alfred Gilman, Mary J. Osbom,
Fred Richards, John Stobo, and Robert R. Wagner.
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pg 424
I hope that
you and the scientific community will go along with the model provided
for us by Feynman when he was on the Challenger Commission. At all
times Feynman preserved and used his prerogative to inform and analyze
publicly.2 I am also appealing
to the Dingell Committee to help the scientific community in having
this Confidentiality Agreement abrogated.
Conclusions. Integrity of scientific consultation destroyed.
On the basis of the documentation I am providing for you, I
conclude that far from using the NAS to provide an independent panel
to 'oversee' its investigation, 'with a view to insuring both the
fact and appearance of objectivity by the inquiry," NIH-HHS are
insuring both the fact and appearance of a cover-up. Indeed, NIH-HHS
have shown that if such a panel comes to conclusions opposed to
the views of the NIH Director, then this Director manipulates the
panel, muzzles the panel, treats that panel improperly, undermines
the panel in the press, disregards its views, misrepresents its
views, and selects other advisers who can be relied on to reflect
the views of the NIH Director. Thus the NIH Director, and HHS,
which has the ultimate responsibility, destroy the integrity of
scientific consultation, which involved the NAS.
Future scientific
consultation compromised. Various publications have reported
the disenchantment of the members of the Richards Panel, and their
wariness of consulting for the government in the future because
of the way they have been treated by NIH-HHS. Science (8 May 1992)
reported this disenchantment anonymously, presumably because of
the Confidentiality Agreement:
"We
took a position we all agreed with, and I'd just as soon not be
burdened with the notion that we've signed off on NIH's decisions,'
says one [member of the Richards Panel], adding: "I'd like it well
known that we don't agree with NIH's decision." Another member puts
the same point more succinctly: "It'll be a cold day in hell before
any of us will consult for the U.S. government again."
Footnotes for page 424
2 Feynman
wrote up his experiences in the article "An Outsider's View of the
Challenger Inquiry' (Physics Today, February 1988). About communicating
with the press he wrote: 'I did, however, keep talking to the press--openly,
always giving my name. I didn't want any hocus-pocus about 'unidentified
sources,' or anything...." For more of the Feynman model, see footnote
4.
pg 425
But the worst
aspect of the chasm between Healy and her independent consultants
is likely to be the doubt into which the panel's report throws NIH's
final conclusions-doubt which NIH adversaries such as Rep. John
Dingell (D-Mich) are already moving to exploit.
I do not go
along with this last editorial evaluation in Science. To me, one
of the worst aspects of the chasm between Healy and her independent
consultants is that the integrity of scientific consultation for
the government has been compromised, because top officials of NIH-HHS
have betrayed their responsibilities toward science, toward the
scientific community, and toward the NAS. Furthermore, I object
to characterizing Dingell as an adversary of NIH. Dingell is a supporter
of NIH in the broad sense, and defends NIH in the long run against
the actions of certain high officials (including NIH Director Healy)
who are now compromising the integrity of NIH.
NAS evasion
of responsibility. The NAS has taken no action that I know of
to protest the way the NAS and the Richards Panel have been used
and abused by NIH-HHS. I wrote to Frank Press last spring, concerning
the responsibility of the NAS, but his reply was evasive (copies
of the exchange are enclosed). Since the responsibility of the NAS
is also involved via Gallo's election to the NAS in 1988, I wrote
to the NAS Council to ask for a public investigation of possible
misleading presentations, or misrepresentations, of his scientific
contributions on that occasion. The Council replied that there would
be no such investigations.3
I object to
the abdication of responsibility by the President of the NAS and
by the NAS Council in the face of the NIH-HHS failures of responsibility,
especially toward the NAS which was directly involved. Therefore
I ask you to read my letter to Frank Press and my letter to the
NAS Council as if they were addressed to you. Since the Council
refused a public investigation, and since Frank Press did not use
his leadership possibilities to object-let alone object strenuously-to
NIH and HHS for their handling of the Richards Panel, I am now turning
to you directly with further Information for action on your part
at the grass roots.
Footnotes for page 425
3 Copy
of the correspondence is enclosed. The exchange was reported
in Science (5 June 1992) under the heading 'Gallo wins one...".
The Council's reply to me was thus interpreted by Science as a victory
for Gallo.
pg 426
For a start,
I urge you to send a copy of this mailing to every member of your
section.
Serge
Lang
cc: Frank Press,
Council of the NAS, Robert Gallo, Bernadine Healy, Louis Sullivan
(Secretary, HHS), James Mason (Assistant Secretary, HHS), Michael
Astrue (General Counsel, HHS), Members of the Richards Panel, David-COSEPUP
Panel, Representative Dingell, John Crewdson, Science and Government
Report (Dan Greenberg), Science (David Hamilton, Ellis Rubinstein,
Fay Flam, Constance Holden, Daniel Koshland), Nature (Barbara Cuuiton
John Maddox), New York Times (Philip Hilts), Washington
Post; (Malcolm Gladwell), and the rest of the cc list of about 250
people.
Enclosures
What They
Said
Exchange of letters between James Mason and Frank Press- Samuel
0. Thier, February-March 1990.
Exchange of letters between Lang and the NAS Council and Frank Press,
April-May 1992.
Confidentiality Agreement.
Cover letter from Richards to Healy, 19 February 1992.
Comments by Fred Richards on the OSI Report, January 29 and 30,
1992.
Cover letter from Healy to James Mason, 27 March 1992.
Letter from Healy to Richards, 11 May 1992.
Reply from Richards, 12 May 1992.
Letter from OSI Director Jules Hallum to Healy, 20 March 1992. 'NIH
Clears Gallo, Patent Probes Go On,' Chemical and Engineering
News, I I May 1992. 'Dissent and Critique" from Dan Greenberg's
Science and Government Report, I June 1992.
pg 427
APPENDIX
Improper
Use and Abuse of the National Academy of Sciences by HHS and NIH
and Distortions of the Views
of the Richards Panel by NIH
This appendix
documents several ways the Richards Panel was improperly treated
by NIH, especially by NIH Director Bernadine Healy.
To a large
extent, organizations have to rely on trust, because one cannot
verify everything all the time. I provide documentation that neither
the Gallo investigation by NIH nor top officials of NIH and HHS
can be trusted. When trust breaks down because of institutional
failures, the workings of an organization are shaken, and it is
very complicated, time-consuming, and energy-consuming to engage
in setting matters straight. When challenging official reports,
I don't ask to be trusted. Although my documentation may appear
bulky to some people, I think it is essential that you see the documentation
so that you can form your own judgment. This appendix is meant as
a preliminary guide.
§1.
Muzzling the Richards Panel: The Confidentiality Agreement
Originally
the Richards Panel expected to speak out as reported in Science
(22 June 1990) by Barbara Culliton, who wrote: "Sources say [Richards]
committee members have promised not to discuss their deliberations
until they are complete. At that point, they expect to 'speak out
loud and clear." -But it turned out very differently. At about the
same time that the members of the Richards Panel saw the OSI Report
in January 1992, they signed a Confidentiality Agreement presented
to them by NIH. A copy of the Confidentiality Agreement is enclosed.
The existence
of this Agreement was reported in the press, e.g. by Science (The
Richards Panel Tosses a Curve," 3 April 1992): 'Members of the panel
contacted by Science declined to discuss their report, privately
expressing their frustration with a confidentiality agreement they
were forced to sign by NIH.' The Science article does not specify
in what way they were "forced.' The reader is thus left to wonder
what is this overpowering force which NIH exercised over presumably
independent scientists. NIH cannot insure "the fact and appearance
of objectivity by the inquiry" unless the members of the Richards
Panel are available to answer directly
questions raised by members of the scientific community about their
reports.
pg 428
I am shocked
that the members of the Richards Panel accepted to sign this Confidentiality
Agreement, thereby abdicating their responsibility to inform and
respond to the scientific community directly at crucial times.
Indeed, versions
of the OSI Report and the Richards Panel Report have been available
to the press. At a time when newspapers such as the Chicago Tribune,
New York Times, Washington, Post, and the scientific press
such as Science, Nature, Science and Government Report, Chemical
and Engineering News have quoted and commented extensively
on these documents, and the NIH Director herself has used the press
to undermine the Richards Panel (see §4 and §5), it is
particularly important that the members of the panel be available
to answer questions publicly about these documents and other matters.
The Agreement
contains a clause: 'Notwithstanding the preceding sentences in this
paragraph nothing contained herein shall bind the signer to refrain
from commenting on the Final Report of this investigation, if and
when it is publicly released in an authorized manner.' This clause
gives rise to another piece of manipulation. By letting the Richards
Panel speak out only after the OSI Report is "publicly released
in an authorized manner,' HHS and NIH are allowed in the meantime
to misrepresent, suppress, and distort data with impunity, to support
the exculpatory views of NIH Director Healy (cf. the conclusion
of this Appendix). Without speaking out, the Richards Panel becomes
an accessory to these misrepresentations, suppressions, and distortions.
With the above clause, NIH and HHS not only forbid the Richards
Panel from countering their manipulations and misrepresentations
as they occur, but they have the prerogative to postpone, perhaps
indefinitely, a public release "in an authorized manner,' thus muzzling
the Richards Panel possibly for a long time, if not indefinitely.
However, it turned out that some members of the Richards Panel expressed
their discontent to the press anonymously, so NIH was not entirely
successful in its muzzling attempts.
§2.
The Richards Panel Did Not "Oversee" the OSI Investigation
Although according
to the letter from Frank Press and Samuel 0. Thier to James Mason,
the Richards Panel was to 'oversee" the NIH investigation, the panel
did no such thing. I shall present two pieces of evidence for documentation.
pg 429
(a) Bypassing
of the panel. When the OSI Draft Report came out in 1991, the
Richards Panel was at first bypassed, as reported by Crewdson (Chicago
Tribune, 17 June 1991):
AIDS
inquiry bypassing watchdog panel A
panel of distinguished scientists set up to ensure the objectivity
of the government's investigation of its most prominent AIDS researcher,
Dr. Robert C. Gallo, is being denied a chance to review the draft
report of the 16-month investigation.
One panel member said that while the group has not yet decided how
to respond to the rebuff, a mass resignation to protest the decision
'certainly remains an option."...
The panelists discovered they were out of the loop last month, when
Bernadine P. Healy, the new NIH director, abruptly canceled a May
20 meeting at which they were to have reviewed the Gallo Report.
In a letter taxed to the panel five days before the scheduled meeting,
Healy said 'issues of fundamental fairness, as well as concerns
for ensuring the security of the draft report,' had led her to decide
that Gallo should be given the report before the panel....
One of the panel members said the panel's chief concern was that
both the scientific community and the public would incorrectly assume
that the Gallo Report had been 'blessed" by the panel members when
it had not even been seen by them....
The abrupt
cancellation of the May 20 meeting was also later reported
in Science (21 June 1991):
Scientists
Get Mad at OSI-NIH
NIH's investigative agency is coming under fire in two
celebrated cases involving Robert Gallo and David Battintore
Richards Panel: Out of the Loop?
... The [Richards] panel had planned to meet last month with
the Office of Scientific Integrity (OSI), which produced the report,
but to the dismay and annoyance of panel members, that meeting was
canceled at the last minute, adding the panel members' voices to
the growing chorus of critics of the way NIH conducts its inquiries
into scientific misconduct....
pg 430
(b) No gumshoe
work by the Richards Panel and suppression of evidence by NIH. The
panel ultimately commented on a document which was presented to
them, apparently with no attempt to find out, for instance, if evidence
was withheld from them. In other words, they did not do 'gumshoe"
work.4 There is some evidence
that NIH suppressed information in its Final Report, and that the
Richards Panel did not "oversee' this suppression. To some extent,
the Richards Panel was maneuvered out of the possibility of overseeing
this suppression.5 Some specific
items will be mentioned in the next paragraph.
Footnotes for page 430
4
Compare
with Feynman's gumshoes when he was on the Challenger Commission.
The following excerpt from Feynman's book 'What do you care
what other people think?' is relevant here:
'Well, that's the point," Senator Hollings
says. "From my experience In investigating cases, I'd want four
or five investigators steeped in science and space technology going
around down there at Canaveral talking to everybody, eating lunch
with them. You'd be amazed, if you eat in the restaurants around
there for two or three weeks, what you'll find out. You can't just
sit and read what's given to you.'
'We're
not just going to sit and read,' Mr. Rogers says defensively. "We've
gotten a lot of people in a room and asked them questions all at
the same time, rather than have a gumshoe walking around, talking
to people one at a time.'
'I understand,' says Senator Hollings. 'Yet I'm
concerned about yo' product if you don't have some gumshoes. That's
the trouble with presidential commissions; I've been on 'em: they
go on what's fed to 'em, and they don't look behind it. Then we
end up with investigative reporters, people writing books, and everything
else. People are still investigating the Warren Commission Report
around this town.'
Mr. Rogers calmly says, "I appreciate your
comments, Senator. You'll be interested to know that one of our
commission members- he's a Nobel Laureate--is down there in Florida
today, investigating in the way you'd like him to investigate.'...
So I saved Mr. Rogers a little bit. He
saw that he had an answer for Mr. Hollings by the good luck that
I stayed in Florida anyway, against his wishes!
5 I do not ask
that the Richards panel report be taken on faith any more than any
other scientific document. I have some reservations myself about some
of its statements, for instance a statement on page 4: "The thoroughness
of the Investigation appears to be excellent. Two sides to each allegation
are clearly and well presented. However, we do question the validity
of the analysis and conclusions in certain instances ..... Although
over many pages the OSI Final Report appears at first glance to present
two sides concerning "allegations" clearly and well, In certain crucial
instances the OSI Final Report does not present certain allegations
clearly and well. See footnote 1. Actually, Richards himself hedged
by using the word 'appears' (to be excellent).
pg 431
§3.
Lack of Verification of the OSI Final Report
The OSI Final
Report was issued 18 March 1992, and was forwarded by Healy to James
Mason with her cover letter of 27 March 1992. However, the response
of the Richards Panel 'Response to the charge to the consultants...'
is based on a version of the report put out in January 1992. Three
changes were made in the meantime, between January and March, as
stated factually in a 20 March 1992 letter from OSI Director Jules
Hallum to Healy. (A copy of this letter is enclosed.) Healy stated
in her cover letter to Mason that these changes were only in "three
minor respects.' However, according to the letter from Hallum to
Healy, one of these respects was "a short summary of the OSI- commissioned
HIV sequencing analysis and its significance to the investigative
findings." This summary of the sequencing analysis confirms that
the isolate HTLV-IIIb, which was used by Gallo to test his HIV blood
test, actually is LAV-LAI (i.e. the French virus). I therefore challenge
Healy's characterization of this sequencing analysis as a 'minor
respect.' In any case, the final version of the OSI Report contains
items which were not in the version of the OSI Report made available
to the Richards Panel in January 1992.
Even more significantly,
the OSI Final Report f"s to include some important findings and
implications of the sequencing analysis. For instance, the summary
does not mention that MO(V), another isolate used by Gallo to make
and test his HIV blood test, is also LAV-LAI.6
A fortiori, the Richards Panel had no opportunity to comment on
these findings.
What is the
point of nominating a panel of consultants to oversee" "with a view
to insuring the fact and appearance of objectivity" and to get 'informed,
unbiased judgments" if the members of this panel are not even shown
the final version of the OSI Report nor asked to comment on this
final version, and if important findings such as those of the sequencing
analysis are not even included in this final version? NIH and HHS
undermine their own credibility by having failed to submit the complete
findings of the sequencing analysis to the scrutiny of the Richards
Panel in the January 1992 version.
By depriving
the Richards Panel of the opportunity to see certain additions in
the OSI Final Report, and to understand what was omitted before
they put out their comments,
Footnotes for page 431
6
On
the other hand, these results of the sequencing analysis are mentioned
In the excerpts from the "Critique' quoted by Dan Greenberg, see
footnote 1.
pg 432
NIH impaired
the Richards Panel's ability to evaluate the decision by NIH not
to determine the extent to which the use of the French viral isolate
by Gallo was inadvertent, and not to pursue the investigation on
this central point.
§4.
Overriding the Richards Panel with Other Consultants
When Frank
Press and Samuel 0. Thier agreed to nominate a panel to oversee
the NIH investigation, they took seriously and in good faith the
stated intent by HHS to insure 'the fact and appearance of objectivity
by the inquiry.' As a result, they specified that HHS would use
only their nominees on the panel. This point was of such importance
that it was specifically reported in the press, for instance by
Barbara Culliton in Science ('NIH Goes the 'Extra Mile' on Gallo,"
23 February 1990, p. 908): 'Press and Thier 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...." NIH Director Bernadine
Healy breached the spirit of the understanding between HHS and the
NAS by using 'her own committee of advisers" above and beyond the
Richards Panel. To the extent Healy used her own advisers (who were
therefore chosen by the government and not the NAS) to override
the Richards Panel, she went against one of the criteria given by
the presidents of the NAS and of the NAS Institute of Medicine to
insure an independent overseeing of the OSI investigation. What
credibility can then be attributed to NIH and HHS officials, to
the NIH investigation itself, and to its exculpatory conclusions?
When the Richards
Panel delivered its comments, NIH Director Healy not only referred
these comments to 'her own committee of advisers,' but she also
used these advisers and the press to undermine the credibility of
the Richards Panel. She put forth public statements to the effect
that Gallo had convinced her and 'her own committee of advisers'
that Gallo had 'compelling' objections to the report of the Richards
Panel, without NIH or Gallo being accountable on the record for
their stand. For example, Barbara Culliton wrote in Nature (7 May
1992):
Then, going
one step further, Healy called Gallo before her own committee of
advisers for three hours on the night of 23 March and challenged
him, in effect, to rebut the allegations
pg 433
of the Richards
Committee. According to Healy, and others who participated in the
interrogation, Gallo did just that. In the words of one participant,
"he blew the directors away, including those prejudiced against
him.' Whether that is an exaggeration or not, participants agree
that Gallo presented compelling evidence in his defense ....
Thus Healy
and her other consultants achieved an exculpatory effect via Nature,
but they acted improperly vis-à-vis the Richards Panel and
the NAS. Culliton's article documents:
- The irresponsibility of NIH and HHS in allowing a situation
to develop when the scientific community is informed through such
press articles, without NIH or Gallo being accountable on the record
for their respective positions.
- Improper manipulation of the Richards Panel by NIH, which
did not give the panel a chance to evaluate and answer Gallo's rebuttal,
or the opportunity to have the panel's point of view accessible
on the record to the scientific community. I don't see any justification
for having Gallo's "interrogation' carried out before Healy's 'own
committee of advisers" and not before the Richards Panel itself,
on the record.
- The undermining of the Richards Panel in the press by NIH
Director Healy and her other consultants.
§5. Healy Undermining the Richards Panel in the Press
Not only did
Healy use Barbara Culliton in Nature to undermine the findings of
the Richards Panel in the press, but she also used the Washington
Post. Malcolm Gladwell's article "NIH Vindicates Researcher Gallo
in AIDS Virus Dispute' (Washington Post, 26 April 1992) was based
on the OSI Final Report and a discussion about the report with Healy,
thus giving rise to an item in Science (I May 1992) under the heading:
'NIH Leak Policy Honored in the Breach.' This item started: 'When
is a leak not a leak? Answer: When it comes from the head plumber....'
In his article,
Gladwell undermined the Richards Panel, for example as follows:
"The Richards Panel neither met with Gallo during the course of
its deliberations nor gave him a chance to respond to accusations.
When Healy met with Gallo last month and gave him for the first
time an opportunity to defend himself against the consultant panel's
charges, she found many of Gallo's answers convincing, she said
later." These sentences are highly tendentious on several counts.
First, Gallo did meet with some members of the Richards Panel
in July 1991 and gave a presentation of his point of view.
pg 434
Second, in
§2(a) above we have seen how Healy did show the OSI Draft Report
to Gallo, thus giving Gallo a chance to respond. Third, the Richards
Panel comments were based on the documentation provided by the January
1992 version of the OSI Report, which had already taken Gallo's
response into account.7 Fourth,
concerning Healy's meeting with Gallo and what "she said later,'
we have seen in §4 how Healy improperly treated the Richards
Panel when she interrogated Gallo in front of other consultants
instead of interrogating Gallo in front of the Richards Panel.
Thus we see
how Healy and the Washington Post cooperated to discredit the Richards
Panel and its conclusions.
§6. Healy's Distortions and Misrepresentations of the
Views of the Richards Panel
(a) Healy's
exchange with Fred Richards. On II May 1992, Healy wrote to
Fred Richards: '... OSI findings pertinent to Dr. Gallo's management
and scientific leadership will be forwarded to [a subcommittee of
the National Cancer Advisory Board]. This will include your written
comments on the OSI Report and the doubts you have expressed to
us about these comments based upon a conversation you had with Dr.
Gallo."
This last sentence
is improper on several counts, for instance because Healy states
that the Richards Panel had "doubts" about their comments. The very
next day (12 May 1992), Fred Richards countered in a reply: "I have
no doubts about our comments then or now. In our phone conversation
I specifically stated that the Comments were based on the written
report from OSI, and that, if there were relevant errors of omission
or commission in that report, some of the Comments might be reexamined
by the panel, but a single hurried phone conversation with Dr. Gallo
is not an adequate basis for reconsideration.... To imply that the
consultants may not stand behind the evaluation stated in the Comments
would be a serious distortion of their views.' Science reported
this exchange (The Last Gasp of the Richards Panel,' 22 May 1992).
Footnotes for page 434
7 In
fact, the OSI Final Report suppressed testimony by Gallo concerning
what isolates he had, when he had them, and what he could use them
for. But this leads into an open-ended critique of the OSI Report,
which is not our main object here. See footnote 1.
pg 435
(b) Healy's
forwarding letter to James Mason. Nevertheless, when Healy forwarded
the OSI Final Report to James Mason, she already invoked the Richards
Panel tendentiously and also misrepresented the Richards Panel.
In her cover letter of 27 March, she wrote:
The proposed
final investigative report was submitted to me on January 17, 1992.
I reviewed the report, and on various aspects of the case sought
the consultative advice of. a group of external consultants known
as "the Richards Panel'; a group of distinguished individual consultants
from the intramural laboratories of the NIH (other than the NCI);
and two scientists from the extramural community. Most of the scientific
consultants are members of the National Academy of Sciences and
none are scientific collaborators with the laboratory under investigation.
The formulation of this transmittal memorandum was substantially
assisted by the knowledge, advice and perspective of the individual
consultants....
Healy's phrase
'substantially assisted by the knowledge, advice and perspective
of the individual consultants' is tendentious in its suggestion
that members of the Richards Panel would go along with her conclusions.
Further on in her letter, Healy downright misrepresented the Richards
Panel as follows:
The consultants
were in general agreement that OSI findings on Dr. Popovic were
fair and appropriate but "nickel and dime stuff....
The consultants believed that it would be impossible to determine
definitively whether there had been inadvertent contamination or
misappropriation of a French virus, resulting in the appearance
of IAI in the reported cultures....
Note that Healy
refers to "the consultants,' thus involving all the above-mentioned
consultants without exception. I question the legitimacy of Healy's
reference to 'the consultants.' The Richards Panel certainly did
not regard the transgressions of Popovic and Gallo as "nickel and
dime stuff." Healy's formulation of the alternative "inadvertent
contamination or misappropriation" is also questionable. In fact,
the Richards Panel charged 'intellectual appropriation." More precisely:
- The Richards
Panel blamed the OSI Report because it "fails to integrate its findings
in 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....'
pg 436
- The Richards
Panel further wrote: "Me Gallo lab 'went to school' with the
French virus, yet they later failed to mention the fact that
they had propagated the French virus. In fact, they denied propagation
of the French virus and stated (in the Popovic et al. manuscript)
that the French virus had never been transmitted to a permanent
cell line. 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...' (underlining in the original
'The
statement that LAV [the French virus] 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."
- In addition,
some members of the Richards Panel have expressed publicly their
disagreement with OSI and Healy, as when one member was quoted by
David Hamilton in Science ('RICHARDS PANEL Scientists-Consultants
Accuse OSI of Missing the Pattern,' 8 May 1992): 'I'd like it well
known that we don't agree with NIH's decision.' That same article
in Science also stated:
'We thought
our report was a reasonably serious document questioning the whole
state of affairs fin the Gallo lab],' says one panel member. 'We
told Healy that if it had been our [investigation], we'd have recommended
that Gallo be found guilty of misconduct.' Instead, this member
says, Healy has not acknowledged receipt of the report, and has
since told the Washington Post that Gallo defended himself effectively
against the Richards Panel's charges.
Thus NIH Director
Healy grossly misrepresented the Richards Panel, and some members
of this panel reacted via Science, but anonymously.
In summary,
Healy forwarded the OSI Final Report to James Mason:
- without
giving the Richards Panel the opportunity to comment on the final
version of the report;
- after involving other consultants and after Gallo's interrogation
of 23 March 1992 in front of these other consultants but not in
front of the Richards Panel;
pg 437
- without
mentioning the very serious disagreement of the Richards panel with
some of the conclusions of the NIH Final Report, thus suppressing
relevant information;
- actually misrepresenting the position of the members of the Richards
Panel by referring to 'the consultants' taking a position on certain
items, when the Richards Panel in fact took an opposite position.
Therefore I have
documented:
- how Healy
manipulated and invoked the Richards Panel improperly, and how she
discredited the original solicitation from James Mason to Frank
Press and Samuel 0. Thier, to nominate an independent group to "oversee'
the NIH investigation;
- the extent to which Healy illegitimately covered herself with
those consultants and with the NAS.
Envoi
I can apply the words of the Richards Panel to the documentation
and analysis I have provided here. I have integrated my findings
in a larger context, namely a pattern of behavior on the part of
top officials of NIH (especially NIH Director Healy) that repeatedly
misrepresents, suppresses, and distorts data and their interpretation
in such a way as to enhance Healy's claim that transgressions in
Gallo's laboratory were merely 'nickel and dime stuff,' and that
there was no 'misconduct' on Gallo's part.
Unlike others
who tend to formulate scientific standards in the straightjacket
of legal terminology, I do not ask whether a generic word such as
"misconduct" applies to the above pattern of behavior. However,
I do ask the NAS and the scientific community whether they will
tolerate this pattern without taking action against it. S.L.
Update,
January 1995
From the Dingell Subcommittee Staff Report
[After the
appearance of the Dingell Subcommittee Staff Report, more information
came to light about Healy's manipulations of the scientists around
her. I quote from page 57 of this Staff Report.]
... Dr. Healy
bypassed the [Richards] Committee and commissioned her own committee
of NIH scientists whom she called her "wise men." Dr. Healy told
her 'wise men" that everything about the committee and their participation
would be completely confidential.
pg 438
In return,
she--without any advance warning-required the committee members
to sign a secrecy agreement. As a consequence, the very existence
of the committee remained hidden for nearly two years.
Despite Dr.
Healy's efforts to handpick and control her "wise men,' they decided
Dr. Gallo should be fired as an NIH laboratory chief One committee
member expressed this determination as follows:
'... Gallo
failed in his responsibilities as the head of the laboratory. His
behavior was seriously discordant with the 'guidelines for the Conduct
of Research in the Intramural Research Program at the NIH .....
The consequences of Gallo's failings have been substantial. At a
minimum, an enormous amount of time and effort has been spent on
these investigations, the efforts of both the French and American
groups have been diverted into unproductive activities and considerable
damage has been inflicted on the scientific enterprise, in general
... I recommend that you remove Dr. Gallo from his position as chief
of the laboratory....'
Faced with
a finding she clearly did not want, Dr. Healy convened a second
meeting of her committee. At this meeting, the 'wise men," who had
been assured that everything about the committee was entirely secret,
suddenly found themselves confronted with Dr. Gallo and his attorney.
The committee members were required to sit through a lengthy and
entirely one-sided presentation by Dr. Gallo and his attorney in
which all wrongdoing was denied, and in which it was suggested that
Dr. Gallo was being hounded for accidental errors and inadvertent
sloppiness in laboratory notekeeping-"that could happen to any of
you.' At the conclusion of the meeting, Dr. Healy demanded a ruling
from the committee as to whether Dr. Gallo had committed scientific
misconduct. The committee members, who had examined none of the
evidence, said they could not make such a judgment.
Dr. Healy's
immediate response was to grant interviews with the Washington Post
and Science, during which she disclosed the existence of her committee,
and claimed Dr. Gallo 'rather effectively refuted' the charges against
him. At the same time, Dr. Healy quoted selectively from memoranda
written by the committee members, attempting to trivialize the negative
aspects of Dr. Gallo's conduct. Dr. Healy never acted on her committee's
recommendation that Dr. Gallo be fired.
VIII.
INTERLUDE: JOURNALISTIC OBSTRUCTIONS
My open letter
of 1 September 1992, addressed to an Section Chairs of the National
Academy of Sciences, reproduced in the preceding section, gave a
summary presentation of the way NIH-HHS and NIH Director Healy mistreated
the Richards Panel, nominated by the National Academy of Sciences
to "oversee' the Gallo investigation at the request of NIH-HHS.
In so doing, she undermined the integrity of scientific consultation.
My open letter was backed up by enclosures consisting of 40 pages
of documentation. This documentation is important in and of itself,
independently of me, partly because it gives evidence for an objectionable
pattern of behavior on the part of top officials of NIH (especially
NIH Director Healy), namely a pattern of behavior that repeatedly
misrepresents, suppresses, and distorts data and their interpretation
in connection with the Gallo investigation and the role of the NAS-nominated
panel.
I submitted
my 10-page open letter for publication in Nature. Nature's editor
John Maddox asked that it be "drastically shortened." I refused
to shorten it, and he refused to publish it. Although he wrote me
that my open letter 'contains a great deal of interesting material,'
he did not publish any of that material either, and so Nature's
readers were not informed about the 40 pages of documentation which
I sent out in the mailing of 1 September 1992.
1. My responsibility.
Since Nature's readers have not been properly informed of this
documentation, which is independent of me, I refused to take responsibility
for a "drastically shortened" piece in which I would have to inform
readers about many facts and documentation which Nature failed to
provide previously, while at the same time I would have to organize
these facts in a pattern and provide an analysis of them. Let Maddox
try to do this job in "drastically shortened" form and see how far
he gets. It isn't for me to take Nature off the editorial hook by
accepting to
pg 440
do a necessarily
inadequate job with slivers of information and undocumented or poorly
documented assertions or generalities, which would give the illusion
of Nature being journalistically responsible, when in fact Nature's
journalism has been defective for a long time, because Nature did
not properly report the pattern of behavior of top NIH officials.
2. Nature's
responsibility. Maddox also replied to me: "Sadly, my long experience
has taught me not to consider publishing contributions from people
who say that their contributions cannot be shortened." Maddox thus
transfers the responsibility of non-publication to me. However,
it is for Maddox to treat the matter as one of professional responsibility
to inform Nature's readers, rather than one of personal dealings
with me. Maddox's answer is defective on several counts:
(a) He covers
himself with a universal criterion about 'people,' as if the problem
he was facing was due to a defect in me (among other 'people'),
instead of dealing with the merits of the given situation. Different
amounts of documentation are needed at different times to deal with
different issues, as far as I am concerned, but not according to
the answer Maddox gave me. He bases his editorial decision whether
to publish "interesting material' only on a factor having to do
with 'people' who submit material to his attention, and not on the
merits or the importance of the documentation in relation to the
case under consideration.
(b) Even though
he accepted that there was 'a great deal of interesting material,'
he makes no analysis of the significance and coherence of this material,
nor does he even consider taking upon himself the responsibility
of shortening this material. For instance, I asked that the Confidentiality
Agreement imposed by NIH on consulting scientists be printed in
full because of its importance as an official document which reveals
a great deal about the way NIH-HHS and some scientists function
in official positions. It is not my responsibility to shorten this
document drastically. Let Maddox take this responsibility as editor
of Nature. In fact, he has taken the responsibility by shortening
the document to the empty set, as far as readers of Nature are concerned.
The 40 pages
of enclosures accompanying my open letter to the NAS Section Chairs
document an intricate and extensive web of failures of responsibility
by top NIH and HHS officials. The enclosures included extensive
primary sources besides the Confidentiality Agreement, for instance
letters from NIH officials and from the NAS-nominated panel, as
well as official NIH and HHS statements to the press. These letters
and public statements document
pg 441
inconsistent
behavior of NIH and HHS officials at different times, and in particular,
the way they go against their own public commitments. To do what
I thought was a responsible job of summarizing the documentation
coherently, instead of just charging NIH-HHS officials in generic
terms, or asking to be taken on trust, I found that I needed all
of my 10 pages.
(c) It is Maddox's
responsibility, not mine, to explain to Nature's readers why they
have not been properly informed about the doings of NIH, HHS, and
Healy, and to provide Natures readers with comprehensive documentation.
Maddox can do so by an article of his own on the 'great deal of
interesting material" which I put together. This material is not
my personal property, and it is Maddox's responsibility as editor
to extract whatever he wants from the primary sources and documentation
which I put together and whatever other documentation is available
to him. So far he has withheld this documentation from Natures readers.
As a result, these readers lack information about NIH and HHS which
would help them to understand the operations of those organizations.
Maddox's letter
to me reveals a great deal about the way he arrives at editorial
decisions for one of the major science magazines in the world, and
how information is withheld from Nature's readers. My experience
is by no means isolated. I urge readers to read the exchange between
Maddox and Neville Hodgkinson (the science editor of the London
Sunday Times). This exchange is dealt with in my essay 'HIV and
AIDS: Questions of scientific and journalistic responsibilities.'
Readers will see how Maddox refused publication of material adverse
to the established view on the HIV causality of AIDS.
IX.
AN EXCHANGE WITH GALLO
On 12 May 1992,
Gallo called me on the phone. The conversation lasted about 10 to
15 minutes. Gallo did most of the talking. He accused me of writing
without knowing the facts. I said practically nothing except that
I awaited the NTH report being made public, and the Richards Panel
Report being made public officially. I stated that I stood by what
I wrote. I also said that I was about to leave within a couple of
days for Europe where I had to give some lectures in various places.
Around the
middle of November, I received from Gallo a letter dated 5 November,
and running as follows.
Gallo's
Letter to Me
Dear Dr. Lang:
I have seen
your recent letters to the Academy. Your continued references to
me regarding matters about which you have no facts and certainly
no understanding of, are deeply disturbing and shocking.
You are wrong
in your understanding of the events concerning our HIV research
or you have been misled. What you have not perceived in any of your
harangues is what I meant by the question 'are you crazy' and the
comment "this is incredible,' which I marked in Popovic's first
manuscript. Moreover, neither has Dr. Richards realized the context
of these comments. You and Dr. Richards know none of the background,
none of the reasons, none of the purposes of those remarks. An outline
fragmentary explanation follows:
(1)
I had little idea of how much or long Popovic cultured LAV. Indeed,
he always indicated to me it was very short term.
(2) Indeed,
LAV grew only with great difficulty. Another HIV (in 1991 identified
as LAV) contaminated one of the French cultures
pg 443
in the summer
of 1983. It is LAI that also contaminated a few of ours, and that
was inadvertently grown. The true LAV could only be grown with great
difficulty. |