Gallo Case - Part 4 Part
2 Part 3
Part 4 - Contents
Interlude: Motives, Intent, and Misconduct pp 523-527
XIV. The Dingell Subcommittee Hearings
of 21 July 1993 pp 528-530
XV. The HHS Inspector General, The
U.S. Attorney, and the IG's Memorandum pp 531-541
XVI. Developments February-July 1994 pp
Page numbers refer to corresponding pages in the paperback edition
of the book "Challenges"
INTENT, AND MISCONDUCT
I shall now
add my own comments on "motives and intent," as well as "misconduct."
Both in the Baltimore and the Gallo cases questions of motives,
intent, and misconduct were brought up. Notably, the HHS-ORI Report
of 30 December 1992 dealt repeatedly with Gallo's "intent" in dealing
with the French AIDS virus. For example, concerning the statement
in the paper for which they charged Gallo with "misconduct," this
report stated: "Gallo intended the statement to deceive others regarding
the growth of LAV."
On the other
hand, the Appeals Board issued the ruling: "The key issue here,
however, is whether Respondent reasonably could have anticipated
at the time of the alleged conduct that such conduct, if proved,
would constitute 'scientific misconduct.'... Even assuming Respondent
engaged in the alleged conduct, this fact alone would not impugn
Respondent's research integrity. If this integrity is not impugned
by the conduct, no administrative action to protect the federal
government interest is needed or appropriate; and applying the label
to Respondent in such circumstances would be fundamentally unfair."
of the Appeals Board is quite remarkable in several ways. For example,
suppose the following conditions prevail systematically in the laboratory
of a scientist working for the government:
does not keep proper laboratory notebooks;
-the data accumulated by the scientist are so confused, or sloppy,
or unkempt that
they are unverifiable; and
-descriptions of experiments by the scientist are so vague or not
(for whatever reason) that the purported results are uncheckable,
and it is not even
clear what factors entered into the experiment.
A major question
as I, and certainly some (how many?) other scientists see it, is
not whether to apply "the label" of "scientific misconduct" to a
person. Rather, we ask the question whether defective scientific
practices are to be tolerated.
accidental mistakes may occur. They happen to all scientists, as
we all know. When is a "pattern of behavior" sufficiently systematic
to merit administrative action (which one?) by persons ultimately
responsible for laboratories, or to merit censure by scientists?
The answer, as far as I am concerned, is not a matter for legal
adjudication. It is a matter for open discussion, based on the public
availability of facts, which I expect to be made available through
suitable investigations by the agencies on which the laboratories
As much as
I agree with the ORI Report and the Richards Panel that Gallo's
misrepresentations denying credit to the French could not be tolerated
by the scientific community without expressing some objections on
the record, I do not agree that the determination of motives or
intent is necessary to evaluate a professional performance. Persons
have a way of adjusting their psychology so that intent and motives
are perceived differently by themselves or others at different times.1
Going into motives or intent results in a morass of differing interpretations
and psychological analyses according to diverse views of psychology.
As a result, going into motives and intent detracts from looking
I object to tying the entire investigative enterprise to a determination
of "misconduct" rather than a determination of facts in the case,
with the result that if no "misconduct" in the above legalistic
sense is found, then "no administrative action is needed." Linking
the investigative process to a determination of "intent" or "misconduct"
obfuscates the possibility of determining and making clearly known
the facts of the case. Actually it has been documented to destroy
this possibility in certain important aspects.
The ORI Report
did not need to go into "intent" to determine that Gallo did something
which would not be tolerated by HHS. Indeed, as far as I am concerned,
the ORI Report and memoranda within NIH gave facts which do not
need to be supplemented with a determination whether there is "intent"
or "misconduct," but these facts often got lost in the shuffle,
as when for instance
Footnotes for page 524
The ORI Report was criticized by others for dealing with "intent."
Science (8 January 1993) reported: "Former OSI Director Jules Hallum,
an investigator on the Gallo case, says, 'the ORI Report is filled
with statements about what Gallo intended. How did they get into
in the New York Times represented Gallo as a martyred saint.
Some of these facts, among others, are:
- that in
successive versions of the paper, sentences written by Popovic were
by Gallo and replaced by successively weaker attribution
of credit to the Institut Pasteur;
Gallo made contradictory statements in explaining what he had done;
- that the viruses called HTLV-IIIB and MOV in Gallo's laboratory
the French virus, and that these viruses were used in the
patent application for the
I don't see the
need to go beyond facts and into "intent" to evaluate Gallo's performance.
What is "misconduct"
anyhow?. At which point are people ready to use words such as "fraud"
or "misconduct" to describe certain actions? At different points
for different people at different times in different circumstances,
of course. But why link the questioning of experiments and data
to charges of intent or motives? There are many forms of conduct
which are undesirable in science:
data selectively, or fudging data in various ways, for instance:
not recorded, or are kept in such a disorganized and messy
fashion that they are
unverifiable, and later a reconstructed version is presented
as the original data;
- falsifying data, or reporting on experiments which were not made;
- not giving
sufficient credit to the work of others, which can take many
plagiarism, or using someone else's results in applying for
a commercial patent;
- refusing to acknowledge mistakes or to make corrections;
- refusing the responsibility of checking the reliability of your
- leaving to others the responsibility of establishing the validity
of what you have
- ad lib.
We find the
determination of "intent" and "motives" as substitutes or principal
criteria for evaluating performance both in the Gallo and in the
Baltimore cases. The New York Times of 6 October 1990 quoted
Dr. Streicher, "a spokesman for Dr. Gallo," as saying: 'There was
no need to use the French strain, and therefore there was no intent
to commit any misconduct. That makes the ethical question moot.
Streicher's reference to "need." Need for what? To grow the so-called
"AIDS virus" continuously in a cell line? Existing documentation
indicates there was such a need. I object to the logic of Streicher's
When the Appeals
Board issued its rulings, it rendered moot the ORI Report, and shifted
the focus of attention from science to legalisms. Facts about the
case, whether those available or those withheld by NIH and HHS,
became secondary. We shall analyze this aspect further in connection
with the decision of the U.S. Attorney not to prosecute, following
the HHS Inspector General's investigation.
It is for the
scientific community to decide whether to accept a deterioration
of standards, or to stand firm against such a deterioration.
looking into motives and intent, and determining "misconduct" in
some legalistic sense, let us raise questions about performance
was achieved, when and by whom;
- the accuracy, truth, or falsity of statements about scientific
about the history of scientific work; and
- the level and standards of performance in carrying out scientific
I urge that
questions about conduct concentrate on facts concerning performance,
and not on arguments as to what constitutes "fraud," "intent," or
"misconduct" and how these words are to be used. Once facts are
established, the scientific community can arrive at de facto decisions:
whether to tolerate certain practices or not, whether to fund certain
laboratories or not, whether to rely on claimed results by certain
persons or not. But even though one does not wish to tolerate a
practice, this does not imply that the practice has to be labeled
fraud or misconduct.
Footnotes for page 526
type of argument was also used in the Baltimore case. For instance,
in the 9 June 1990 Economist we find: "But she [Imanishi-Kari] has
put forward one argument eloquently, which Dr. Baltimore has sympathetically
repeated: what possible motive could she have to cheat?... If scientists
were other than human, this might be a good argument. If scientists
had not in the past invented data to support conclusions that they
believed, but could not yet otherwise prove, it might have some
weight. But they are human, and it has happened before."
not imply that the practice has to give rise to legal or quasi-legal
proceedings. Rather, let us have official reports clearly informing
us of the facts in the case.
XIV. THE DINGELL SUBCOMMITTEE HEARINGS
21 JULY 1993
in full below the opening statement by Dingell at the hearings for
Lowell T. Harmison
STATEMENT OF THE HONORABLE JOHN D. DINGELL, CHAIRMAN SUBCOMMITTEE
ON OVERSIGHT AND INVESTIGATIONS
WEDNESDAY, JULY 21, 1993
today is part of a Subcommittee investigation that bears directly
on the integrity of public service and the integrity of the scientific
In April 1984,
the U.S. Government announced with great fanfare that government
scientists had discovered the virus that was the cause of AIDS and
developed a blood test to detect antibodies to the virus. These
developments were heralded by Health and Human Services (HHS) officials
at the news conference as "a triumph of science" and "another miracle"
added to "the long honor roll of American medicine and science."
Eventually, the U.S. Government received a patent on the blood test;
numerous other related patents were applied for and received.
No sooner was
the HHS announcement out than suspicions followed by outright concerns,
were heard to the effect that:
(1) the U.S.
Government scientists' supposed "discovery" was not their own; these
scientists actually "discovered" another scientist's virus and used
it for their putative breakthrough; and
(2) the U.S.
Government had engaged in "inequitable conduct" before the United
States Patent and Trademark Office, having seriously failed in its
duty of disclosure to that office.
In 1985, these
matters erupted into a full-blown patent dispute, a dispute that
extended for nearly two years, through no less than four legal proceedings,
culminating in a negotiated settlement. This settlement has come
under increasing criticism as its factual underpinning have evaporated.
the settlement, the controversy did not die. Within the scientific
community, there were continuing concerns about possible improper
conduct in the National Institutes of Health (NIH) laboratory of
Dr. Robert Gallo. Significant questions about what information was
provided to--and withheld from--the U.S. Patent Office remained
unresolved. And it was not long until evidence began to appear that
strongly challenged U.S. Government actions during the patent dispute.
Today, as the
Subcommittee nears the end of its investigation of this matter,
an investigation hindered and greatly prolonged by continued obstructionism
at the NIH and elsewhere, there is substantial evidence of problems
in, and there are serious concerns about, the government's handling
of the matter:
(1) It is now
clear that the virus used to make the United States HIV antibody
blood test is the virus discovered by scientists at the Institut
Pasteur. Moreover, the cell line used to grow the virus was the
cell line discovered by a scientist at yet a third laboratory. After
years of denial, it is absolutely clear that both the virus and
the cell line that were claimed as new discoveries of the U,S. Government
scientists were actually those of other scientists and merely given
These are not
the Subcommittee's judgments; they are the judgments of the scientific
community. In the case of the virus, the findings were confirmed
in a paper published in the prestigious journal Nature, just
a few weeks ago.
(2) When the
U.S. Government sought a patent on its alleged "discoveries" relative
to the HIV blood test, officials apparently withheld from the U.S.
Patent Office information directly and materially relevant to the
examination of the Government's patent applications--information
showing the claimed invention actually had been made long before
by other scientists.
HHS officials, as well as HHS and DOJ attorneys, apparently possessed
evidence at the time of the patent dispute that, at a minimum, pointed
to very serious doubts that the U.S. Government's patent claims
could be substantiated. But international prestige and significant
financial rewards apparently made defense of the U.S. patent paramount.
Consequently, these U.S. Government officials may have willfully
ignored and, in some instances, actively suppressed that evidence.
Also, as the
Subcommittee investigation has proceeded, we have encountered repeated
instances of obfuscation and obstructionism on the part of past
and current Government officials that suggest a certain reluctance
to confront the facts. Documents have been destroyed.
have been withheld for protracted periods. In several instances,
the documents known to exist have never been produced from the official
Fries. And some witnesses have refused to appear voluntarily.
today is necessary only because Dr. Harmison, a key figure in the
events under review, has chosen not to cooperate with a Subcommittee
request for a staff interview. This lack of cooperation has not
been tolerated in the cases of the Environmental Protection Agency
or the Department of Defense witnesses in the past and it cannot
be ignored in this instance.
is at a loss of understand why routine cooperation was not possible
here, and the absence of a staff interview creates a great deal
of uncertainty as to what information will be received today. Because
of this uncertainty, and out of an abundance of caution, without
objection the Subcommittee determines that the testimony "may tend
to defame, degrade, or incriminate any person" and, under Rule XI(2)(k)
of the Rules of the U.S. House of Representatives, the hearing will
be closed to the public. The chair notes that a quorum to take testimony
is present, as required by that rule. Other Members will be recognized
for opening statements and then there will be a brief recess to
clear the room. After that we will proceed to administer the oath
to Dr. Harmison and receive his testimony.
XV. THE HHS INSPECTOR GENERAL, THE
THE IG'S MEMORANDUM
Suzanne Hadley who headed the NIH-OSI Gallo investigation before
being forced out by Bernadine Healy, the OSI did not consider questions
having to do directly with the patent application, because OSI was
advised by the HHS Office of the Inspector General that such questions
might require a criminal investigation. Similarly, the ORI did not
consider such questions.
General did carry out an investigation. It found sufficient cause
to present a case to the U.S. Attorney's office in Baltimore, MD.
In January 1994, the U.S. Attorney's office declined to prosecute
the case, and wrote a letter dated 10 January 1994 to the HHS Inspector
General to inform the IG of the U,S. Attorney's position.
addressed several issues: legal technicalities and legal concerns,
the previous history of the ORI case, the validity of the ORI case,
the legitimacy of the patent application, the legitimacy of the
royalties, and responsibilities on a broader basis (HHS, the scientific
community, the government, and the "court of public opinion"). I
shall now give a summary of the letter.
reasons for the U.S. Attorney's office not to prosecute. The
letter gave an account of those reasons. It stated that "... certain
procedural rules governing criminal prosecution prohibit us from
prosecuting many of the alleged false statements and other conduct
of Drs. Gallo and Popovic, no matter what we might think of the
relative merits of such a prosecution."
of limitations. After mentioning some of the "possible crimes"
under consideration, such as making a false statement,
of justice or agency proceedings, and perjury, the letter invoked
"the statute of limitations which bars prosecution for any such
conduct which occurred prior to December 1988, which includes almost
all the statements at the core of this case."
- Lack of
jurisdiction. The letter stated that "several of the statements
allegedly made by either Drs. Gallo and/or Popovic were made in
the District of Columbia, and are therefore beyond our consideration
for individual prosecution." Aside from that, the U.S. Attorney
also recalled that "the U.S. Attorney's Office for the District
of Columbia previously considered, and declined, prosecution" when
the HHS Inspector General's office presented the case to them previously.
on the patent for the blood test. Concerning the royalties,
the letter stated: "Any such prosecution, such as for mail fraud
... or conspiracy to defraud the government ... would require the
government to prove beyond a reasonable doubt that Drs. Gallo and
Popovic knowingly and willfully devised a scheme to defraud the
government of its property by means of false statements and representations.
However, when the patent relating to the AIDS test was applied for
in 1984, neither Drs. Gallo nor Popovic were entitled to share in
the royalties for the discovery, nor could they have known at the
time that the Technology Transfer Act of 1986 would authorize such
payments ... we have also considered the investigation and report
of the patent firm of Allegretti and Witcoff, which independently
conclude that Dr. Gallo's statements in connection with the patent
dispute were not 'prima facie' false, but rather subject to varying
interpretations. Moreover, even the Office of Research Integrity
acknowledged that any allegedly false statements were 'minor'; and
did not invalidate the underlying research. Thus we do not believe
we would be able to sustain our burden of proof to demonstrate several
important elements of any federal offenses relating to the receipt
of royalty payments."
doubt." After noting the above obstacles to prosecution, the
U.S. Attorney's letter also stated that the U.S. Attorney "was not
satisfied that there is a substantial likelihood of convincing a
jury beyond a reasonable doubt that either Dr. Gallo or Dr. Popovic
acted with the requisite criminal intent."
- The Appeals
Board decision and ORl's dropping the Gallo case vis-à-vis
the Appeals Board. Finally, the U.S. Attorney's letter brought
up the fact that in facing the Appeals Board, the ORI "was unable
to meet a far lesser standard of proof, that of preponderance of
evidence or 51% in its effort to convince the Board that Dr. Popovic's
conduct involved intentional false statements."
stated explicitly that the U.S. Attorney "could not ignore the conclusion
reached by those independent arbiters" concerning the Popovic case,
and also could not ignore "the decision of the ORI to forego even
the presentation of evidence regarding the alleged misconduct of
Dr. Gallo, some of which was independent of the actions of his subordinate
U.S. Attorney's letter did not stop with such legalistic considerations.
It brought up two other kinds of issues.
responsibility in regards to the royalty payments. The letter
stated: "Our decision not to seek prosecution of Ors. Gallo or Popovic
does not mean that we believe they should continue to receive their
annual royalty payments. On this issue, we express no opinion other
than to observe that Dr. Gallo, as of approximately May 1991, has
acknowledged that it was the French Institute Pasteur sample sent
to his laboratory which formed the basis for the AIDS test. Whether
he and Dr. Popovic should continue to receive their royalties under
such circumstances, or whether the government should make any effort
to recoup any payments made to them since then, are matters which
are more appropriately addressed by the Department of Health and
considerations of responsibility. The final part of the prosecutors'
letter to the HHS Inspector General addressed general considerations
of responsibility. I quote the last paragraph fully. "In deciding
not to seek prosecution, we recognize that this case transcends
the normal type of criminal case, and that the conduct of these
two noted scientists reflects upon the integrity of the scientific
process, the National Cancer Institute, and indeed the conduct of
our government as a whole. However compelling is the need to provide
a forum for historical accuracy on these issues, that noble desire
cannot be a substitute for evidence, nor does it justify using the
criminal courts in place of the court of public opinion."
Thus the letter
from the U.S. Attorney to the HHS Inspector General in its last
two sections threw back the Gallo case party to HHS and party to
the scientific community.
an article by John Crewdson in the Chicago Tribune (see below)
reported that, "Officials close to the case said the evidence gathered
by the Inspector General, including thousands of pages of documents
and interviews with some two dozen witnesses, would now be provided
to the House Subcommittee on Oversight and Investigations, which
is also investigating the case .... "
Thus the Gallo
case was also thrown back to the Dingell Subcommittee.
from the U.S. Attorney to the HHS Inspector General was not reported
in the New York Times. It was reported in the informative
Crewdson article "U.S. declines to prosecute AIDS researcher Gallo"
(Chicago Tribune, 21 January 1994, p. 1). Crewdson's article
was approximately 3,800 words long, and provided extensive quotes
from the letter, and mentioned its multiple points. Some accounts
of this letter were also given in Science ("Feds Drop Gallo
Criminal Probe," ScienceScope, 28 January 1994 p. 459), and
Science and Government Report ("Saint or Scoundrel? The Gallo
Controversy Goes On," 1 February 1994, p. 6). As a result, two things
1 February 1994, I wrote to the HHS Inspector General's office to
get a copy of the letter from the U.S. Attorney, under the Freedom
of Information Act. On 6 April 1994, I received a reply that this
item (and others I had asked for) "which are part of an open and
ongoing investigation are exempt from mandatory disclosure under
the FOIA [Freedom of Information Act] by exemption (b)(7)(A)."
14 March 1994, I wrote to Science editor Ellis Rubinstein
to ask him for a copy of the above letter, because we had corresponded
about this letter, and he had sent me some quotes from it, without
sending me the entire letter. On exactly the same day that I received
the notice from HHS that they could not disclose the letter, I received
a copy of the letter from Ellis Rubinstein.
These two simultaneous
events document the extent to which we live in a Kafkaesque world.
piece "Feds Drop Gallo Criminal Probe" (Science, 263,
28 January 1994, p. 459) was approximately 300 words long, and reported
the refusal of the U.S. Attorney to prosecute. It stated unambiguously:
"Rather than exonerate Gallo, however, the prosecutors pegged their
decision to legal hurdles." This piece mentioned briefly some of
the reasons the U.S. Attorney gave for the refusal to prosecute,
and the next to last paragraph of the ScienceScope piece
was: "Contacted by Science, Gallo said he was 'frustrated'
that the prosecutors said they halted the probe due to technicalities
rather than a lack of evidence of wrongdoing. 'My reputation is
everything,' he says. 'I still have no public forum to clear my
that piece did Science even allude to the fact that portions
of the U.S. Attorney's letter to the HHS Inspector General dealt
with the broader issue of responsibilities, as mentioned in §l(b)
and §l(c). The reporting by Science was selective
in the following manner:
could not learn from Science that the prosecutors had expressed
concern with more than "legal hurdles" and "technicalities."
brought to the fore Gallo's complaint about a lack of "forum"
to clear his name, while at the same time Science did not mention
the "forum for historical accuracy" and the "forum of public opinion"
brought up by the prosecutors.
did not mention the existence of passages in the U.S. Attorney's
letter noting that Gallo acknowledged three years ago that the virus
which he and Popovic used to develop the blood test was the French
virus. In particular, there is no mention of any sentence such as
the one stating: "Whether [Gallo] and Dr. Popovic should continue
to receive their royalties under such circumstances, or whether
the government should make any effort to recoup any payment made
to them since then, are matters which are more appropriately addressed
by the Department of Health and Human Services."
did not give the information that the U.S. Attorney's letter
stated: "In deciding not to seek prosecution, we recognize that
this case transcends the normal type of criminal case, and that
the conduct of these two noted scientists reflects upon the integrity
of the scientific process, the National Cancer Institute, and indeed
the conduct of our government as a whole."
The last paragraph
of the ScienceScope piece, coming immediately after the Gallo
quote about the lack of a "public forum to clear" his name, stated:
"One ordeal remains for Gallo: Representative John Dingell (D.-Mich.)
is expected to release a report on the Gallo case in May." This
paragraph represented a specific point of view at the expense of
others. Indeed, a question which may arise for some scientists (including
me) is not whether "one ordeal remains for Gallo," but whether there
will finally be made public documentation about the HIV blood test
patent application and the behavior of the U.S. Government in this
connection. There is also the issue of NIH withholding information
over several years, and NIH stonewalling Dingell's request for information
and documents pertaining to the patent application and what went
on in Gallo's laboratory.
To me certainly,
whether the truth about these events is an "ordeal" for Gallo is
a secondary matter.
Science did not report, as Crewdson did in the Chicago
Tribune, that the HHS's Office of the Inspector General would
provide thousands of pages of documents and interviews to the House
Subcommittee on Oversight and Investigation. Therefore Science
did not provide relevant information, and reported the "expected"
release of Dingell's Report in a manner which slanted the issues
concerning the integrity of NIH and the government.
affected differently, according as Science reports issues
one way or another. Scientists' reactions and the way they exercise
their responsibilities are also affected very differently depending
on whether they are, or are not, informed of the broader concerns
of the U.S. Attorney.
Some of My Conclusions
of the HHS Inspector General in a "criminal investigation" rather
than in the dissemination of accurate information (establishing
a "forum for historical accuracy"), so that the "court of public
opinion" could operate in an informed way, had major consequences.
At the very least:
(a) Much information
was withheld, certainly from the public and especially from scientists
outside the government, but also possibly from OSI and ORI themselves.
For instance, did OSI and ORI have available the "thousands of pages
of documents and interviews with some two dozen witnesses" when
they were doing their own investigations? The supposedly non-legal
offices OSI and ORI of HHS did not consider the matter of the patent
application because originally the HHS Inspector General's office
thought it involved questions which might give rise to prosecution,
so there arose a Catch-22 situation, one of whose effects was to
prevent some information from reaching scientists, let alone the
public. Questions which OSI and ORI claimed could not be settled
on the basis of evidence which they had available might have been
settled if they had the evidence gathered by the Inspector General,
but kept from them for legal reasons.
As a result
of a legalistic approach, official and clear answers were not provided
to a number of specific questions which had been raised about the
patent application. It was, and still is, the responsibility of
HHS, of the scientific community (especially of the Richards Panel),
and of Dingell's Subcommittee to provide documented answers.
(b) The U.S.
Attorney's decision not to prosecute provided an internal contradiction
in the attempts by various segments of the government to shed light
on the events of the Gallo case. As far as I am concerned, this
decision showed in a spectacular way the bankruptcy of some attempts
to resolve certain questions of scientific responsibility via the
legal system. I repeat here the warning of Paul Doty, already quoted
in connection with the Baltimore case (Nature, 18 July 1991,
But the essence
of change must come within the scientific community by its reassertion
of its ability to police itself.... This challenge to readdress
the fundamental tenets of acceptable behavior in science comes at
a time when the traditions of the scientific enterprise are under
new threats arising from new stresses and temptations ... all these
contribute to the pressure to compromise and erode the high principles
of the past. As a result the scientific community may already be
experiencing a gradual departure from the traditional scientific
standards; this could be abetted to condoning the behavior seen
in this present case. In this way we risk 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--not only to itself and the
inspiration which carries it forward, but to the public trust which
is its provider."
How would HHS,
NIH, the scientific community, and the Dingell Subcommittee, meet
their responsibilities from now on?
The IG's Memorandum
the prosecution requested by the Inspector General's office did
not take place, the IG issued a 35-page memorandum which surfaced
in some of the press, for instance:
Shot From a Closed Case," by Jon Cohen, Science Vol. 265,
1 July 1994, p. 24.
"U.S. inquiry discredits Gallo on AIDS patent," by John Crewdson,
Chicago Tribune, 19 June 1994, p. 1.
As far as I
was able to determine, the IG's memorandum was not covered by the
New York Times.
It was only
mentioned incidentally in the New York Times' article on
the patent revision (see XVI, §3).
The IG's memorandum
was very negative toward Gallo. It deals mostly with the patent
application, although it also recalls false statements made by Gallo
throughout the eighties. I shall quote one example from the memorandum
dealing with the patent application, since we have not discussed
the patent application so extensively elsewhere.
from the IG's Memorandum, 10 June 1994. During 1986, the [patent]
examiner rejected the pending claim in several Gallo et al. follow-on-applications
... on grounds that the work of the IP [Institut Pasteur] scientists
was "prior art" to Gallo et al ....
of the IP work to that of Gallo et al. was affirmed by the PTO
[Patent and Trademark Office] examiner, when she became aware
of it. The examiner advised the OIG [Office of the Inspector General]
that, had she been aware of the IP prior art at the time she examined
the blood test application of Gallo, she would have suspended
prosecution of the Gallo application and declared an interference
between the two applicants.
Joseph Onek, on behalf of Gallo, wrote a letter to the Inspector
General June Gibbs Brown on 23 June 1994, stating:
memorandum of June 10, 1994 concerning Dr. Robert Gallo and Dr.
Popovic is filled with an extraordinary number of errors reflecting
deliberate factual distortions, scientific illiteracy and obvious
bias. The most significant errors are as follows:"
12 items. Onek also wrote that the memorandum was a "disgrace" and
"should be withdrawn immediately."
I shall give
here an example of a false statement by Onek to allow readers to
form a more informed opinion. I find this example the easiest to
understand of many such examples, because it requires no knowledge
whatsoever of the Gallo case and its history. The matter has to
do directly with an item that is in the IG's memorandum, and the
fiat assertion by Onek that this item is not there. Who is making
"errors" and "factual distortions"?
FALSE STATEMENT BY GALLO'S LAWYER
Onek's letter of 23 June 1994 to the HHS Inspector General,
item 3, p. 2: The [IG] memorandum never mentions that
HIV-Lai contaminated LAV Bru at the Pasteur ....
the IG's memorandum, p. 15. Gallo's records show the following
reagents were sent from the IP to the LTCB in 1983:...
16. Two shipments of LAV virus--in July 1983 and September
1983. The September 1983 shipment of LAV contained two samples
with different identifiers; however, both examples were believed
to contain the same virus, from patient BRU. In reality, as
demonstrated in 1991 by Wain-Hobson et al. [Science; 252,
pp. 961-965] and confirmed by the Roche analyses, in 1993
[Nature, 1263, pp. 466-469] one of the September LAV/BRU
samples had been accidentally contaminated at the Institut
Pasteur and overgrown with LAV/LAI; consequently, in September
1983, Gallo et al. received one sample each of LAV/BRU and
Therefore Onek's statement is false, in a particularly striking
and obvious way. I shall give more similar examples in XVI, 94.
The false statement
by Onek is especially grave, because Onek questioned the motivation
of the Inspector General by commenting: "The failure of the OIG
to mention these accidental contamination's demonstrates its total
bias and its unrelenting effort to disparage Dr. Gallo's contention
that the similarity in HIV-Lai and III-B is best explained by an
accidental contamination in both laboratories." So what does Onek's
false statement "demonstrate"? To whom?
As a scientist,
Gallo is responsible for the lawyer's statements issued on his behalf,
and for correcting these false statements. To my knowledge, he has
not done so. Conversely, the scientific community is entitled to
hold Gallo responsible for the statements made by his lawyer on
Onek also objected
that the IG's memorandum "never mentions that, as the Office of
Scientific Integrity made clear, Dr. Gallo's laboratory had another
isolate, HIV-RF, which could have been used for the AIDS blood test.
Popovic recommended that it be so used.) The existence of RF removes
any motive for Dr. Popovic or Dr. Gallo to misappropriate the French
virus and strongly supports the contention that the similarity of
III-B and HIV-Lai is the result of an accidental contamination."
(a) We have
already dealt in detail with the point about the isolate RF in our
discussion of the OSI Report (V, §3). Gallo's lawyer actually
was continuing a line first promoted in William Raub's press conference
of 5 October 1990, that the existence of certain "isolates" in Gallo's
laboratory were somehow exculpatory, or showed that Gallo had no
motivation to appropriate the French virus. (Cf. the discussion
(b) The second
half of the sentence, concerning an "accidental contamination,"
again contains an unjustified innuendo. Of course, the sample of
what was thought at the time to be LAV-Bru was contaminated by LAV-Lai
at the Pasteur Institute, as stated in the IG's memorandum. However,
the point made in the IG's memorandum (and made by others throughout
the case) is that Gallo used the French virus for his blood test,
whatever patient this virus came from (Bru or Lai). For purposes
of determining whether Gallo used the French virus, it is irrelevant
whether this virus came from one patient or the other.
The rest of
Onek's points can be analyzed similarly in light of the documentation,
and thus can be shown to be without merit at best, or outright false.
Having worked out several examples, I leave others as exercises
for the reader. Of course, by issuing false statements and misrepresentations
via his lawyer, Gallo succeeded in accumulating complications which
caused more and more exchanges, and made it increasingly difficult
for people without the appropriate background or stamina to determine
As usual, I
am especially interested in the way exchanges such as the one between
the IG and Onek-Gallo are handled in the scientific press. The article
by Jon Cohen in Science reporting on the IG's Report started:
"The latest headline grabbing investigatory report in the case of
Robert Gallo and the discovery of the AIDS virus reads like a brief
for the prosecution in a scientific fraud case against the National
Cancer Institute researcher." I would describe the IG's Report as
a carefully and meticulously documented account of Gallo's misrepresentations
over the years.
Jon Cohen quoted
uncritically the sentence from Onek to the effect that the IG's
memorandum "is filled with an extraordinary number of errors, reflecting
deliberate factual distortions, scientific illiteracy and obvious
bias." Cohen also quoted Onek's
that the memorandum was a "disgrace" and "should be withdrawn immediately."
Cohen made a special point of systematically and uncritically contrasting
assertions from the IG's Report with objections raised by Gallo's
lawyer Joseph Onek, in the letter to the Inspector General. He did
mention that Onek did not address the statement I reproduced from
the patent examiner, but otherwise he uncritically repeated Onek's
Science did not inform its readers of the existence of false
statements such as the one I have reproduced above or of the other
example I shall give in XVI, §4. Thus Science misinformed
its readers by a defective analysis of what Onek wrote. Readers
for the most part do not have original documents in hand, and even
if they do, they may not have the time or inclination to follow
up the merits or demerits of various positions. For the most part,
they may rely on Science to do the appropriate processing
of information and summarizing for them. The examples I have given
may help the reader evaluate not only Onek's statements but the
way Science analyzes news items. Caveat emptor.
"New" Evidence: The Myers Documents
from a letter dated 23 February 1994
From John Dingell to NIH Director Harold Varmus
Available under the Freedom of Information Act
For over two
years, the Subcommittee on Oversight and Investigations of the House
Committee on Energy and Commerce has pursued an investigation of
the Institut Pasteur/American HIV blood test patent dispute and
related matters, including the research of Dr. Robert C. Gallo and
his associates at the National Cancer Institute's (NCI) Laboratory
of Tumor Cell Biology (LTCB). Newly discovered documents raise additional
concerns about Dr. Gallo's candor and forthrightness on these matters.
These and related concerns were not addressed, much less resolved,
by any of the recent HHS investigations because the documents were
withheld from the investigators ....
as mid-December 1993, the Subcommittee was still receiving documents
that had been withheld for two years. Most recently, the Subcommittee
learned of the existence of a cache of documents never provided
to the Subcommittee, located in the NIH Freedom of Information Act
(FOIA) office. (FOIA officials told Subcommittee staff that prior
to January 1994, they were never informed of any of the Subcommittee's
document requests.) Not only were these documents withheld from
the Subcommittee, their existence was not disclosed to the NIH Office
of Scientific Integrity (OSI), to the Office of Research Integrity
(ORI), nor to the Office of the Inspector General (OIG) of the Department
of Health and Human Services (HHS) ....
discovered documents are of great significance; they bear on the
still-unresolved central issue of the entire case, i.e. the possible
misappropriation of the Institut Pasteur (IP) virus, LAV. The documents
principally comprise correspondence
Gerald Myers, a leading HIV geneticist, and a number of NIH scientists
and senior scientific administrators, including Drs. Robert Gallo,
Anthony Fauci, and Samuel Broder ....
of the correspondence is the genetic identity of LAV and "HTLV-IIIb'...
In brief, the
Myers/NIH correspondence shows that: (a) as early as April 1987,
Dr. Myers had concluded that Dr. Gallo's account of the origins
of his prototype virus (i.e. the claim that IIIb was independent
from LAV and the claim that IIIb was derived from blood pooled from
several patients) constituted a "double fraud" and that this "fraud"
had resulted in significant deleterious effects on progress in HIV
research; (b) by April 1989, Dr. Gallo himself had finally decided
to "throw in the towel," and admit publicly that his virus was derived
from the IP virus; and (c) Dr. Gallo reneged on his commitment to
make this public acknowledgment. The implications of these developments
should be assessed in the context of Dr. Gallo's conduct and statements
concerning the identity of the viruses over the years, as well as
Dr. Gallo's failure to disclose this highly relevant information
of the Myers/NIH correspondence are summarized in a Subcommittee
staff memorandum attached to this letter. The substance of the "Myers"
documents (and their greatly belated submission to the Subcommittee,
not to mention the fact that the documents were never provided to
OSI, ORI, or the HHS OIG) are matters of considerable concern. The
contents of these documents, particularly in light of the conclusions
of the Richards Committee and many members of Dr. Healy's irregular
secret committee, raise renewed concerns about Dr. Gallo's veracity
and forthrightness on these matters.
is interested in hearing your views on this matter and what actions
you plan to take. You may want to ask selected members of the Richards
Committee, or other independent scientists, to review this new information
and to advise. Given the importance of these issues, we request
a response by Wednesday, March 9, 1994 ....
letter was cc-ed to Dan Schaefer, Ranking Republican Member of the
Subcommittee; Philip Lee, Assistant Secretary of HHS; Harriet Rabb,
General Counsel of HHS; June Gibbs Brown, HHS IG; and Fred Richards.]
The Subcommittee staff memorandum mentioned by Dingell in his
letter to Varmus is dated 15 February 1994. It is 7-1/2 pages long,
and contains extensive quotes from the primary sources,
that is, letters
from Myers and statements from Gallo, substantiating Dingell's summary
statements in his letter to Varmus. Both Dingell's letter and the
Subcommittee staff memorandum to Dingell are available under the
Freedom of Information Act, together with other "Myers documents."
To give readers
an idea of the context in which the Myers documents occurred, I
quote one passage from a memorandum from Myers to Gallo available
under the Freedom of Information Act. Most of this passage is also
quoted by Dingell's staff in their memorandum to Dingell dated 15
from a memorandum, from Gerald Myers to Gallo, 3 July 1989: I
gave you some tree analyses for the IIIb and LAV sequences. We have
exhaustively verified these results and I just don't think they
are going to change from what is seen .... I don't like being the
person to have to tell you this, but I'm happier that the information
is in my hands than in the hands of someone else. Up ahead, you'll
have reason to think that I have worked against you (I don't think
that, but I could understand how you would reasonably think so);
this is the strongest argument against your position and the Tribune
has not learned of it or anything of that sort. I have held it for
nearly a year now, hoping for some resolution within the tradition
rather than within the press...
It has been
my hope that you would not be placed into a "reactive" position
but rather a position of taking the initiative. It has been my
hunch that the Tribune series (assuming it is going to be published,
which is always a strained assumption)1
I would be deflated by a bold move on your part. I understand
that you are not as free in this regard as you would ideally be
and, I could be wrong in my hunch. Let me know your thoughts and
how I can help. I do feel some obligation to the French and to
the database along these lines, but those considerations do not
impose a time constraint ....
The Latest from Fred Richards
of the Myers documents by the Dingell Subcommittee had a very substantial
effect on Fred Richards, and some effect on members of his panel.
Footnotes for page 544
fact, Crewdson's first article came out in November 1989.
Government Report reported this latest evolution, because
they accepted to have an interview with Dan Greenberg. Crewdson
subsequently informed readers of the Chicago Tribune (19
June 1994) where he quoted Fred Richards' statement from SGR,
but Science, Nature, and the New York Times did not so
inform their readers.
Science and Government Report
"Advisor in the Gallo Case Calls for Reopening of Probe"
Like an underground
fire that won't go out, resentment continues to seethe over the
official exoneration of the renowned Robert C. Gallo from charges
that he robbed French researchers of credit for identification
of the AIDS virus.
a long silence, Frederic M. Richards ... told SGR in an
interview on April 25 that two items of newly available evidence
warrant a reopening of the investigation.
cited sworn statements by a French researcher, Francoise Barre-Sinoussi,
head of the Retrovirus Biology Unit at the Pasteur Institute
item of evidence cited by Richards is a recently discovered cache
of letters and memoranda in NIH files written by Gerald Myers,
a researcher at the Los Alamos National Laboratory who served
as Principal Investigator of the HIV Sequence Data Base, under
a contract from NIH. Myers reported to NIH that his researches
indicated that LAV, and not Gallo's HTLV-III, was the cause of
AIDS. Myers subsequently stated that after his findings were brought
to Gallo's attention, Gallo gave but then reneged on an assurance
that he would publish a statement reflecting Myers' conclusion
purpose of this whole investigation," Richards said, "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."
three of Richards' colleagues on the misnomered "Richards Panel,"
SGR found all dissatisfied with the outcome of the Gallo
case, but uncertain over what if anything should be done about
it at this stage ....
nor the New York "Times reported the evolution of Fred
Richards or members of his panel. If you are surprised, come to
the front of the class because you haven't been paying attention.
Revision of the Patent Agreement
1994, the Institut Pasteur pressed the Clinton administration, and
the new NIH Director Harold Varmus, for an acknowledgment that the
Americans (Gallo) had used the French virus for the HIV antibody
blood test, and for a revision of the patent agreement. The communications
from Pasteur's Director Maxine Schwartz to Varmus are available
under the Freedom of Information Act. Partly under the threat of
a renewed law suit by the Pasteur Institute, and partly under pressure
from the HHS Inspector General's memorandum, a new agreement was
reached, substantially increasing the share of royalties going to
the Pasteur Institute. The new agreement was covered in the press,
Quick Reversal on Gallo Patent Dispute," Science and Government
Report, 1 July 1994.
"U.S.-French Patent Dispute Heads for Showdown," Science,265,
1 July 1994,
"AIDS-BLOOD-TEST ROYALTIES--NIH-Pasteur: A Final Rapprochement?,"
Science, 265, 15 July 1994, p. 313.
"Key Patent on AIDS To Favor the French," New York Times, 12
"U.S., France settle AIDS virus dispute," Chicago Tribune, 12
July 1994, p. I.
As late as
8 June 1994 Varmus had replied to Maxime Schwartz that "the acknowledgment
of the role of the Institut Pasteur in isolating the AIDS-causing
virus was very slow to occur, causing much frustrating litigation
and other unproductive activity," but nevertheless Varmus was adamant
that the previous agreement would not be modified. However, when
the IG's Report came out a couple of days later on 10 June, Varmus
changed his tune and the new agreement was reached. The abrupt change
is noted both in the Chicago Tribune and the Science article,
in complementary ways, which are instructive to understand how the
to Crewdson: "Asked Monday whether the Inspector General's inquiry,
details of which first were reported last month in the Tribune,
had played any role in the reversal of the U.S. position on the
royalty issue, Varmus appeared to hesitate before replying, "Very
little." Sources said a more probable explanation for the shift
was the lawsuit Pasteur was prepared to file had negotiations failed.
The suit claims that HHS concealed evidence from, and made false
representations to, the French that induced them to settle the case
in 1987. In an impassioned letter to Varmus last month, Schwartz
declared bluntly that 'a cover-up of the true facts was deliberately
undertaken so that we would settle.'"
to Science, I July 1994, p. 25: "Varmus formally replied
to Schwartz on 8 June. In his 'considered judgment,' the NIH
director wrote, the royalty arrangement should stand .... Then came
the OIG's 10 June report. Two weeks later, Varmus wrote Schwartz
a letter with a different tone..."
Varmus reinforced somewhat the role of the HHS Inspector General's
Report on his own thinking, as reported in Science two weeks
to Science, 15 July 1994, p. 313: "Varmus acknowledged,
however, that a 10 June report of an official investigation into
Gallo's lab by the HHS Inspector General, which was critical of
Gallo (Science, 1 July, p. 23), 'had some catalytic role
in my own thinking.'"
At the same
time, Varmus explicitly stated that no "deliberate misconduct by
the government" was found, and his disclaimer about "culpability"
or "wrongdoing" by the government or Gallo was reported in the press
articles mentioned above. In any case, the choice by Varmus on 1
July to minimize the effect of the HHS Inspector General's Report
on himself ("very little") raises a fundamental objection: When
the higher-ups themselves do not take seriously into account the
information which comes officially from their own organization,
or minimize the importance of this information, then something is
fundamentally cockeyed. But that's the way "the system works," as
the saying goes. And Varmus is very much part of "the system."
General's memorandum is mentioned only incidentally with a few words
in the New York Times article, and no direct connection is
made between the appearance of this memorandum and the change of
mind by Varmus to reconsider the patent agreement.
York Times provided no analysis of the IG's memorandum.
Running Interference by Gallo's Attorney
In XV, §4,
I have already given one example how to process information when
I analyzed a significant false statement made by Gallo's attorney
Onek in his letter to the HHS Inspector General (23 June 1994).
I shall give below two more samples of juxtapositions which can
be made to compare Onek's assertions with the record. Readers can
obtain the whole Onek memorandum from Gallo directly at the LTCB.
I urge readers to compare what Onek wrote with the ORI Offer of
Proof and the HHS IG's Report, which contain documented factual
assertions about the history of Gallo's behavior, as well as repeated
lists of scientists willing to testify about Gallo's deviation from
accepted standards. It is possible to make up similar juxtaposations
with several other statements by Onek, a task which I leave as an
exercise for the reader.
interference by the legal system. There is another issue
here, transcending the question whether Onek's statements are
compatible with documented reality. This is the issue of
a scientist dealing with other scientists through the legal system.
I object to Gallo interposing a lawyer between himself and the scientific
community. As a scientist, Gallo is directly responsible to the
scientific community, which is entitled to hold him directly
accountable for what Onek writes on his behalf.
Onek writing for Gallo, in his letter to the HHS Inspector General,
23 June 1994, p. 6: The [Inspector General's] memorandum neglects
to mention that the Pasteur, by its own admission, has no legal
rights to more blood test patent royalties. That is why the Pasteur
does not bring its case to court. Instead the Pasteur makes an "equitable"
claim for more royalties. But Pasteur officials let French citizens
become infected with AIDS in order to promote Pasteur's commercial
position. What possible equitable claims can such officials have?
And how can American officials support such claims?
In fact, American
officials have supported the claims. The patent agreements were
revised at about the same time Onek wrote to the Inspector General.
Furthermore, the Institut Pasteur was continuously threatening litigation.
Readers can compare Onek's statement with the following:
- The HHS
Inspector General's Report, p. 27, which we have already quoted
in XVI, §4: "Gallo did not disclose to the United States Patent
Office the Pasteur scientists' 'prior art,'" i.e., their extensive
work with the virus, LAV, and the existence and use of the LAV antibody
blood test. Further, Gallo did not disclose to the patent office
any of the LTCB's own experimental work with LAV.
of the IP's [Institut Pasteur] work to that of Gallo et al. was
affirmed by the PTO [Patent Office] examiner, when she became aware
of it. The examiner advised the OIG [Office of the Inspector General]
that, had she been aware of the IP prior art at the time she examined
the blood test application of Gallo, she would have suspended prosecution
of the Gallo application and declared an interference between the
- The letter
from NIH Director Harold Varmus to Maxime Schwarz, Director of Institut
Pasteur, 8 June 1994. In this letter Varmus stated: "The acknowledgment
of the role of the In-strut Pasteur in isolating the AIDS-causing
virus was very slow to occur."
- The statement
by Varmus when he announced the new patent agreement, 11 July 1994,
that HHS and NIH "officially acknowledge" that Gallo's lab "used
a virus provided to them by Institut Pasteur to invent the American
HIV test kit."
- The report
in the Chicago Tribune (12 July 1994, "U.S., France settle
AIDS virus dispute," p. 1) that "Pasteur was prepared to file
had negotiations failed. The suit claims that HHS concealed
evidence from, and made false representations to, the French that
induced them to settle the case in 1987."
As for Onek's
allusion to the French officials who let French citizens be infected
with AIDS, it is correct that French officials in the medical bureaucracy
allowed an existing blood supply contaminated with HIV to be exhausted
before applying the available blood test. Since Onek brought up
the issue, it is relevant to recall here that these French officials
were condemned to jail terms.
On the other
hand, Gallo himself refused to communicate some scientific information
to certain colleagues at NIH. This information concerned the cell
lines in which he was growing HIV. For this we come to our second
After I circulated
Suzanne Hadley's critique of the Nicholas Wade-New York Times
article representing Gallo as a martyred saint, Onek wrote a
memorandum on Suzanne Hadley's critique, and he wrote me a letter
dated 17 June 1994, stating: "As the attached memorandum demonstrates,
that critique is filled with errors and distortions. I trust you
will now circulate my memo to your correspondents." I did circulate
Onek's memorandum, but I also pointed to possible comparisons with
the documented record. For example, Onek made the following statement:
Onek, writing for Gallo, in his memorandum concerning Suzanne Hadley,
p. 8: "No effort was made by the LTCB to deny others the use
of the H9 clone (the most successful of the cloned cell lines of
HUT-78) or to hide the origins of the parental line. Records indicate
that the LTCB made H9 available to at least 45 laboratories in 17
countries in 1984 alone. Dr. Popovic reported the HLA pattern of
the H9 cell line clone in Lancet in 1985. Thus scientists
throughout the world had the opportunity to determine for themselves
the relationship of H9 to one or another HUT-78. This includes Drs.
Bunn and Gazdar, the co-developers of the HUT-78 cell line, who
were the recipients of H9 in 1984."
compare Onek's assertion with the record, as documented in the ORI
Offer of Proof. There, from pages 49 to 71 one sees continuously
documented how Gallo obscured the cell line, refused to communicate
it to some colleagues at NIH, and how he was ordered to do so by
higher-ups at NIH. Several scientists are listed as willing to testify
to Gallo's transgression of scientific standards, for instance,
Martin, Schaffer, Curran, Richards, Tramont, Goldberger, Rall, Raub,
Morgan, and McGinnis. I recall here a few of these references:
ORI Offer of Proof
p. 49. Meanwhile Dr. Popovic renamed the parental
cell line, changing the name from "HUT-78" to "HT."... Dr. Gallo
systematically misrepresented the origins of the HT cell line so
that his fellow-scientists could not discern HT was really HUT-78
53. Numerous ORI witnesses will testify that it was a
serious deviation from accepted practices for Dr. Gallo not to
identify HT/H9 as a derivative of HUT-78, or at least to disclose
this possibility, both in the initial Science paper describing
HT and H9 and in subsequent communications...Among the witnesses
... are Dr. Schaffer, Dr. Curran, Dr. Richards, and Dr. Tramont.
57, The evidence will show that despite clear standards
in the scientific community that reagents should be freely distributed
to responsible scientists, Dr. Gallo (I) refused outright to provide
the uninfected H9 cell line to some researchers; (2) delayed providing
the cell line for substantial periods of time for some scientists,
while other scientists were promptly provided the reagents; (3)
imposed restrictive conditions on the cell line to virtually all
to whom he supplied it, with particularly onerous conditions for
scientists not in his favor;...
61. Refusal/delay in providing reagents: Gallo's
treatment of certain of his PHS colleagues was particularly outrageous
.... Dr. Malcolm Martin, a laboratory chief at the National Institute
On Allergy and Infectious Diseases, NIH, requested the uninfected
cell line from Dr. Gallo. Exhibit H-89 .... Dr. Gallo refused
Dr. Martin's request...Exhibit H-102. Dr. Gallo also demanded
to know what Dr. Martin intended to do with the uninfected cell
line; Dr. Gallo explicitly stated that he did not want Dr. Martin
to attempt to grow LAV in the cell line. Exhibit H-102 ... the
agreement sent to Dr. Martin contained two additional particularly
outrageous conditions: "Work with these reagents will not be published
without prior approval by Dr. Gallo." and "Reagents will not be
used in comparisons with other viruses."
68. Dr. James Mason, formerly director of the CDC and
former Assistant Secretary for Health, will testify that so egregious
was Dr. Gallo's refusal to provide his reagents to CDC scientists
who had requested them that he was forced to intercede on behalf
of CDC researchers whose requests for the cell line and other
reagents had not been honored by Dr. Gallo .... ORI witnesses
will testify that Dr. Gallo informed CDC staff that LTCB intended
to delay sharing of the reagents until Dr. Gallo felt he had accomplished
his own work with the reagents.
Dr. Gallo's conduct was so antithetical to the mission of PHS and
standards within the scientific community that, at a June 18, 1984
NIH AIDS Executive Committee Meeting, Dr. Wyngaarden specifically
ordered Dr. Gallo to provide the uninfected cell line to Dr. Malcolm
Martin and Dr. Walter Dowdle. Exhibits H-99, H-103.
70-71. In addition to the witnesses identified above,
Drs. Goldberger, Rall, Raub, Morgan and McGinnis will testify
to the accepted norms of scientific practice for identification
of unique cell lines and their availability to the scientific
community and Dr. Gallo's deviation therefrom.
In the memorandum
about Hadley's critique, Onek also repeated what he wrote to the
HHS Inspector General about the French blood test scandal. We have
already dealt with this item in Example 1. Suzanne Hadley herself
replied in a letter to Onek dated 14 July 1994: "No amount of fingerpointing
at Luc Montagnier, the French Government, or anyone else will alter
the nature and consequences of Bob's statements and actions, or
make them any more praiseworthy. Yes, the French did have a blood
test scandal. They at least dealt with it; they at least put their
miscreants in jail .... "
concluded her letter to Onek with the statement: "The record is
compelling. The truth--in its entirety, and at long last--will come
out. It really will."
Failures of Scientific Responsibilities
Gallo affair provides evidence of the way the scientific community
is unable to police itself.
- The NAS and
IOM have systematically evaded responsibilities from beginning to
end, culminating with the "convocation" on misconduct of 6-7 June
1994 (see my essay "Maintaining Standards"). I remind readers that
Gallo was elected to the NAS in 1988.
forces in the government and in the scientific community obstructed
the search for the truth in the Gallo affair. I list some items
documenting obstructions following the nomination of the Richards
Panel by the NAS and IOM at the request of HHS-NIH: The "reining
in" (dismissal) of Suzanne Hadley by NIH Director Bernadine Healy,
thus derailing the investigations; the subsequent manipulation and
mistreatment of the Richards Panel by NIH, especially Healy; the
withholding of documents
from the Richards
Panel (e.g., the Myers analyses and the Roche analysis), from ORI,
and from the Dingell Subcommittee; the panel's acceptance of this
treatment without protesting publicly; the evasion of responsibility
of the NAS and IOM toward the Richards Panel; the fact that we have
to learn of the Richards conclusion from Science and Government
Report, but do not get this information from NIH-HHS, the NAS,
or Science (never mind Nature, which is a dead loss).
- In Spring
1994 Fred Richards concluded that "they stole the virus," but he
said that "we didn't know that at the time these [investigative]
reports came out." Actually, some scientists such as Don Francis
had been saying that all along. One reason some other scientists
did not know is that under Bernadine Healy, the Roche analysis was
withheld by OSI from the Richards Panel at the time the OSI Report
came out in 1992, and the Richards Panel did not investigate independently
to find out what was being withheld from them. Also under Bernadine
Healy, and continuing for months after she left, NIH stonewalled
requests for documentation from the Dingell Subcommittee. Ultimately
it was not the scientific community which uncovered the Myers documents,
it was the staff of the Dingell Subcommittee; and we learned some
of this information from Dan Greenberg and John Crewdson, not from
Science or Nature.
- The Onek-Gallo
replies to scientific governmental evaluations, and the aborting
of the ORI and HHS Inspector General's investigations by the legal
system, show how lawyers are pushing the scientific community to
adopt legalistic thinking, which is on the way to replace the exercise
of scientific responsibility. The main criterion for acceptable
behavior is quickly becoming that if what one does is not demonstrably
illegal (and, in particular, criminal intent cannot be proved),
then it's OK. NIH Director Varmus and the Secretary of HHS have
so far done nothing official about the reports of ORI and the HHS
IG, and Gallo was still Chief of LTCB in Fall 1994.
- In the ORI
Offer of Proof, one sees repeatedly that a couple of dozens of scientists
were willing to testify about Gallo's multiple transgressions of
scientific standards, including Don Francis, Montagnier, Barre-Sinoussi,
Martin, Curran, Cabradilla, Goldberger, Rall, Morgan, Raub, Huth,
Richards, and other members of the Richards Panel, Schaffer, Tramont,
Woolf, McGrath, Hadley, etc. But we have to get the Offer of Proof
individually under the Freedom of Information Act to get this information.
We did not get this information from the NAS, from Science, or
from official reports of the Richards Panel. Why should scientists
with governmental investigating agencies if their efforts are ignored
or disregarded by the higher-ups, in the government and in the science
documentation is massive, and some (many? most?) individual scientists
may consider that they have other things to do besides processing
the information contained in the documents arising from the case.
On the other hand, the standard journals don't provide the information
properly (Science, Nature, etc.).
- The abdication
of responsibility by the higher-ups in the science establishment
(NAS, IOM, NIH, HHS, and the scientific journals such as Science
and Nature) make it very clear that individuals who attempt
to maintain standards are isolated, or disregarded, or obstructed
by the scientific establishment. This is the lesson derived from
the Gallo case for those scientists who would be willing to detract
from time possibly spent on research, to get engaged in a battle