Gallo Case - Part 5 Part
2 Part 3
Part 5 - Contents
The Dingell Subcommittee Staff Report pp 555-600
Page numbers refer to corresponding pages in the paperback edition
of the book "Challenges"
THE DINGELL SUBCOMMITTEE STAFF
Obstruction and Withholding of Information by NIH
Subcommittee experienced considerable difficulties in obtaining
information from NIH. These difficulties were mentioned by Dingell
himself as quoted in the preceding section, and I learned of them
via the usual sources of information, Greenberg's Science and
Government Report, or Crewdson's articles in the Chicago
Tribune, but not from Science or the New York Times,
to mention only two of the mainstream press. I quote from the
to Greenberg's Science and Government Report of 1 December
1992, Dingell accused NIH Director Healy of hampering the Gallo
probe as follows:
In a nine-page-single-spaced
letter dated November 26, Dingell accuses Healy and close associates
of deliberately, perhaps illegally, thwarting his inquiry into NIH's
dispute with the Pasteur Institute over patent rights to the blood
test for the AIDS virus ....
my "patience is near an end," Dingell declares in his letter to
Healy that "there is a clear pattern of delay, obstructionism,
and abuse in the NIH's actions in this matter that is intolerable,
and strongly suggests that a cover up is under way."
letter to Healy presents a long inventory of difficulties that
his Subcommittee staff has encountered in obtaining documents
from NIH related to the patent controversy, which Dingell's Subcommittee
is investigating as part of its long-running inquiry into how
science polices its use of public funds.
instances, Dingell wrote, NIH denied the existence of documents
but then turned around and supplied
his staff insisted that they were in NIH files ... Dingell writes:
"... The NIH apparently is still withholding documents."
(b) In his
Chicago Tribune article of 6 December 1992, concluding a
section entitled "Political Science," Crewdson wrote:
belatedly that she [Suzanne Hadley] was expected not to expose the
facts her investigation had turned up but to bury them, Hadley jumped
ship. Although she is still on the NIH payroll, Dingell asked several
months ago that she be assigned to his staff ....
She has become
profoundly disillusioned with the agency for which she once cared
deeply. "There never was an iota of a chance," Hadley says, referring
to what she calls the original cover-up, "that NIH would do the
honest thing. Before anything had even happened the die was cast,
the decision was made. After that it was simply a matter of crafting
a litigation strategy."
... But Hadley's
background--during the years at NIH she never received a rating
lower than "outstanding"--has given Dingell's current crusade
an unusual degree of credibility.
her new colleagues now have nearly all the pieces of the puzzle
in place, and sources there say they believe they know what happened
in Gallo's lab. When the subcommittee publishes its findings,
the historical record perhaps will be complete at last. It will
be too bad for scientists that the truth came not from science
but from Congress....
(c) We have
seen in XVI, §2, how Dingell's staff finally extracted the
Myers documents from the files of NIH in December 1993, after these
documents were withheld from Dingell over the years,
The Dingell Subcommittee Staff Report
As of January
1995, the Dingell Subcommittee on Oversight and Investigation was
no more, because of the Republican majority victory in November
1994. However, the Subcommittee staff had prepared a report which
is mostly due to the work of Suzanne Hadley, and which became available
during January 1995. This report is 267 pages long. It is accompanied
by an Executive Summary, 65 pages long.
had written to Dingell in 1994 to urge the Subcommittee to issue
the report on the Gallo case.1
It is unfortunate that the political circumstances have prevented
this report from being available from the Government Printing Office,
especially since there were Republicans on the Subcommittee, which
on this issue appeared bipartisan. Individual scientists and the
media now have the responsibility for the distribution of the Subcommittee
Staff Report, which contains extensive documentation. Much of this
documentation has not been publicly available before, partly because
NIH covered it up. The full text can be accessed via the World Wide
Web at the following URL:
Footnotes for page 557
1 For example:
23 January 1994, from Elliott Lieb to Dingell: "I am writing to
urge, in the strongest possible terms, that your committee issue
a full report on the Gallo case. It is clear that this case and
its importance did not die with the Appeals Board ruling. It is
also clear that the public, and especially the scientific community
needs to know everything that your committee found despite the obstructions
laced in your way. We need this information if we are to maintain
high ethical levels in science and in the administration of science."
(Elliott Lieb is Jones Professor of Mathematical Physics at Princeton,
and is a Member of the NAS.)
4 February 1994, from John Edsall to Dingell: *As a biochemist who
is deeply concerned with maintenance of standards of integrity in
scientific work, I have followed the controversy over the discovery
and identification of the virus of AIDS, with particular reference
to the role of Dr. Robert Gallo... I believe that the standards
of ethical conduct for scientists are, and should be, more demanding
than the purely legal rules. They must be so, if the public is to
retain its confidence in the scientific community. In fact, looking
at the history of the Gallo investigation, I see a pattern of evasion,
and suppression of information, at several points along the line
.... It appears, however, that the attempt to clear Dr. Gallo of
all legal charges against him is on the verge of complete success.
If you have strong evidence that could lead to a different conclusion,
would not this be the time to make it public, in the interest truth
and honesty...? (John Edsall is Professor of Biochemistry Emeritus
at Harvard, and is a member of the NAS.)
7 February 1994, from Charles Park to Dingell: "You are to be congratulated
for your continued pursuit of the truth in the Gallo case. What
you have done and hopefully continue to do is very important arid
is much appreciated by the scientific community. I understand that
your Subcommittee on Oversight and Investigation has collected information
on the Gallo case that has not previously been made public. I hope
the Committee will make a full disclosure of this material." (Charles
Park (M.D.) is Professor Emeritus of Physiology, and is a member
of the NAS.)
remains for individuals, and especially scientists, to speak out
and act. I personally distributed copies of the Staff Report to
a cc list of over 100 persons throughout the United States, and
in addition, I sent a copy for duplication and distribution to
the Council of the National Academy of Sciences.
of the Academy, from whom I had never heard previously, wrote me
on 26 January 1995 concerning the Staff Report:
... I have
read through all 336 pages of the depressing document and I strongly
agree that NIH must do something. As a lawyer would say, the appropriate
remedy should include, but not be limited to, the following:
1) The Director,
NIH should issue a public apology to the IP on behalf of present
past officials who engineered this appalling
coverup, and on behalf of the scientific
staff of NIH.
2) All rights
under the present HIV test patent should be assigned to the IP
Drs. Barre-Sinoussi, Chermann, and Montagnier.
3) The Staff
report of the Dingell Committee should be made a part of the NIH
Report for 1995.
4) All royalties
received by the U.S. government during the entire term of the
should be remitted with interest to the Institut
5) All payments
to Drs. Gallo, Popovic, and Sarang should be retrieved and returned
apart from repayment of money, there is no mention of punitive
actions against anyone: this is not a legal matter, it concerns
the good name of NIH.
that Dr. Varmus would likely be fired in short order if he attempted
to do any of this, but nothing would do more to create an issue
that scientists, especially intramural NIH scientists, could speak
out about than that[ For him it would be a wonderful opportunity
to become known as the first NIH Director who actually stood for
something besides the efficient absorption of federal funds.
suggestions. Enclosed is a check to help with your distribution
costs for all those: reports. I should have sent it long ago when
you were fighting the Huntington case, but better late than never.
was signed by William A. Hagins, Laboratory of Chemical Physics,
National Institute of Diabetes and Digestive and Kidney Diseases.
Staff Report confirmed the findings of the Inspector General's
Memorandum and the ORI Offer of Proof, as far as they went.
of the Subcommittee Staff Report shows once more the extent to which
the main scientific press and the mainstream press have not provided
proper, documented information to the scientific community and to
the public at large, Greenberg and Crewdson excepted. On the other
hand, it provides one more opportunity to learn or acknowledge the
facts, and to speak out. I shall quote extensively from the Staff
Report. I begin with extensive quotes from the introduction
to the Executive Summary.
Subcommittee on Oversight and Investigation
Committee on Energy and Commerce
U.S. House of Representatives
A. The Subcommittee's
Focus on the Institutional Response
by prominent scientists, the Subcommittee on Oversight and Investigations
in 1987 began a review of the institutional response to cases of
alleged or suspected scientific misconduct by scientists involved
in federally supported research. At that time, the problem was readily
discernible. When situations of possible scientific misconduct arose,
the institution's response generally was to walk the whistle-blower
out the door, sweep the problems under the rug, and to protect,
at all costs, the reputations of the senior scientists. As one scientist
explained, "It was as if they had their own fiefdoms whereby they
set their own rules."
In April 1988,
the Subcommittee held what it expected to be its first and only
hearing on the problems associated with how the
were responding to instances of scientific misconduct. What the
Subcommittee did not recognize at the time was that rather than
pointing out a problem that the community would rally around in
an effort to correct, it was, in fact, exposing a not very well-kept
secret that the scientific community was not prepared to deal with.
To those who
were attempting to expose these problems, the hearing was a breath
of fresh air. In the 24 hours after that first public hearing, the
Subcommittee received reports of no fewer than 18 new cases of alleged
scientific fraud. To those who wanted to maintain the status quo,
the Subcommittee became a threat; numerous attempts were made to
thwart the Subcommittee's efforts and limit Congressional oversight
of Federally funded scientific research.
Given the debate,
the Subcommittee felt it was important to go into the issue in further
detail, and much as it did with defense contractors, generic drug
manufacturers, and the nuclear power industry, the Subcommittee
decided to select a case study to determine, in detail, how institutions
respond to allegations of scientific misconduct and whether the
system, in fact, works.
The case study
selected for review was the so-called "Baltimore" case. The primary
reasons the Subcommittee focused on this case were that (a) two
institutions had already had--and botched--an opportunity to properly
investigate the matter and (b) the whistle-blower had been effectively
driven out of science for her efforts in bringing the facts to light.
The further the Subcommittee pursued the case, the more the community
rallied around the defense ....
Even as the
Subcommittee began to see some progress at research institutions,
it was evident that effort had been geared toward research institutions
outside the Federal government. At the time, over a billion dollars
was being spent at the National Institutes of Health (NIH) on intramural
research. Consequently, it was important to determine if the same
unwillingness to deal effectively with cases of potential misconduct
observed in non-Federal institutions also existed within the Federal
government's own research community. As a result, the staff was
directed to conduct a case study involving allegations of misconduct
in an intramural research program.
Sorry History of Misconduct Investigations
At this time,
the Subcommittee was investigating the Laboratory of Tumor Cell
Biology (LTCB) within the National Cancer Institute (NCI} at NIH,
due to allegations of kickbacks and diversion of
by two prominent scientists within that laboratory. Ultimately,
both investigations resulted in felony convictions. As a result,
in 1989, when allegations of scientific misconduct resurfaced against
the chief of that laboratory, allegations which had first been raised
in 1985-86, the Subcommittee was in a good position to use the LTCB
as its intramural case study.
to the situation at extramural research institutions, there has
been little or no progress at the Department of Health and Human
Services (HHS) or NIH in their response to cases of possible scientific
misconduct in the intramural laboratories. In fact, the situation
at HHS/NIH resembles the situation at extramural institutions more
than ten years ago ....
The only real
attempt at NIH to vigorously examine the facts of this case occurred
when Dr. William Raub was the Acting Director of NIH. Dr. Raub insisted
on the appointment of an independent panel, nominated by the National
Academy of Sciences (NAS), to review HIH's handling of the case,
to ensure an adequate response.
the NIH assigned its new Office of Scientific Integrity (OSI), assisted
by an outside panel of experts, to conduct a formal inquiry and
investigation. While this beginning was very positive, it shortly
unraveled. In 1991, a new NIH Director was selected: Dr. Bernadine
Healy. By the time of her appointment, the OSI investigation had
been completed and a draft report had been prepared .... Concerning
Dr. Gallo, the entire panel and OSI severely criticized Dr. Gallo
and they strongly questioned his fitness to continue to serve as
a laboratory chief at NIH. But then, through a series of events
described later in this report, Dr. Healy effectively demolished
OSI, greatly limited the supposedly independent review of the NAS
Committee, and eventually attempted an end-run of its findings.
In short, Dr. Healy did everything she could to protect her superstar,
In 1993, the
NIH directorship changed again with the selection of Dr. Harold
Varmus as Director of the NIH. The atmosphere of overt protectionism
of Dr. Gallo was ended. However, although the HHS Office of Inspector
General (OIG), the United States Attorney, and the Subcommittee
had by this time amassed a substantial body of evidence demonstrating
probable misconduct, Dr. Varmus, who was advised throughout by HHS
General Counsel Harriet Rabb, refused to forward that evidence to
a Surgeon General's Board of Inquiry, the duly authorized disciplinary
body for the members of the HHS Commissioned Corps. Dr. Gallo is
a Captain in the Corps.
despite strenuous pressure from attorneys and top officials of the
Institut Pasteur (IP),
refused to even consider a possible reallocation of royalties from
the HIV blood test patent until he was confronted with a serious
threat of an imminent lawsuit. Even when he finally agreed to a
reallocation of the royalties, Dr. Varmus (with HHS' blessing) merely
negotiated an increase in the IP share of the royalties, based on
a disingenuous explanation of accounting anomalies, rather than
the proven fact that the LTCB scientists, contravening a formal
transfer agreement, used an IP AIDS virus isolate to make their
of this transfer agreement are given on p. 24, as follows.]
The IP virus
received at the LTCB in September 1983 was accompanied by a transfer
agreement that stipulated the virus would "... not be used for any
industrial purpose without the prior written consent of the director
of the Pasteur Institute."
agreement further bound the recipient, "... not to disseminate the
virus in any form (to companies or other scientists) without the
prior written authorization of the Director of the Pasteur Institute."
Popovic, a top LTCB scientist, signed the transfer agreement on
September 23, 1983, affirming, in addition to the above, that the
IP virus, "... will be used by the recipient himself, exclusively,
and only for the following research purposes...: (a) biological;
(b) immunological and (c) nucleic acid studies."
of the Subcommittee's Findings
view of the so-called "Gallo case" is that it is about whether Gallo
et al. "stole" or misappropriated the IP virus. While this is indeed
the central, original issue relative to the LTCB scientists, the
case as it bears on the institutional response subsumes other vital
issues, including how political and international reputational imperatives
at HHS assumed preeminence over scientific integrity, and how defending
the claims of the LTCB scientists came to be perceived as tantamount
to defending the United States Government itself.
relating to the institutional response include the following: (1)
the validity of HHS' claims to the United States Patent and Trademark
Office (PTO), in applying for a patent on the LTCB HIV antibody
blood test; (2) the integrity of HHS' response to the IP challenge
in the mid 1980s, including the tacts and substance of legal briefs
filed on behalf of Gallo et al; and (3) the integrity of HHS current
response to the mounting body of evidence
question the actions and statements of both NCI scientists and HHS
1. Did Gallo
et al. Misappropriate the IP Virus? [The Executive Summary
then goes into some concrete evidence, partly confirming the evidence
already mentioned coming from the Offer of Proof and the HHS IG
Memorandum, and partly some evidence which I had not been aware
2. The Institutional
Response: The manner and content of HHS' response to the challenge
to Gallo et al. was set as early as April 23, 1984, the day of the
HI-IS press conference. Although a few crumbs were thrown to the
IP scientists, the glory was all for Gallo et al. and the United
States Government. Numerous unsubstantiable claims were made at
the press conference by "our eminent Dr. Gallo," as HHS Secretary
Margaret Heckler repeatedly described him. Secretary Heckler also
elaborated at some length how the LTCB scientists' "discoveries"
proved the administration's commitment to AIDS/HIV research.
before the press conference, HHS submitted applications for U.S.
patents on an HIV antibody blood test and a method of producing
the virus. These patent applications contained the seeds of the
French/American dispute; they contained fundamental assertions that
could not be substantiated. Chief among these was the assertion
"... we are
the original, first and joint inventors ... of the subject matter
which is claimed and for which a patent is sought..."
The real inventors
of the HIV blood test were the IP scientists, who had developed
and begun to use their blood test the previous Summer (1983) ....
Dr. Gallo and
his colleagues did not disclose to PTO their knowledge and use of
the IP blood test, nor did they disclose the IP scientists' considerable
body of scientific work on their virus and blood test ....
The HHS response
to the IP challenge, which at this time was informal, was immediate
and reflexive. The response was to de-fend--at all costs and irrespective
of the evidence--the claims of Gallo et al. The Subcommittee investigation
showed that HHS officials and attorneys conducted a parody of an
investigation; they did not seek the truth, but rather sought to
create an official record to support the claims of Gallo et al.
HHS officials accepted
everything they were told by Dr. Gallo and his colleagues, incorporating
the LTCB scientists' information unqualifiedly and without confirmation
into official reports of the Department. When these officials encountered
hard evidence that contradicted the NCI/HHS claims, the evidence
was ignored, discarded, and/or suppressed.
in turn, took the "facts" they were given by NCI/HHS and incorporated
them, often nearly verbatim, into U.S. Government pleadings in the
Claims Court and before the PTO. At the same time, HHS and DOJ sought
by every means at theft disposal to thwart IP's discovery of evidence
that would reveal the truth about the LTCB claims. According to
attorney's notes and participants' accounts, despite top HHS officials'
awareness that many of the claims of Gallo et al. were, at best,
highly questionable and without substantiation, HHS determined to
"play out" the U.S. defense as long as possible, and "roll over"
only when defeat became inevitable.
The HHS agency-level
cover-up started early. In August 1985, HHS charged NCI to "investigate"
the claims of Gallo et al. The investigation was conducted by a
single individual--Dr. Peter Fischinger--one of Dr. Gallo's superiors
who even before he started his inquiry, pronounced the LTCB claims
solid and entirely valid. Dr. Fischinger's investigation resulted
in the so-called "Fischinger Report," which became the central substantive
document on which the HHS/DOJ attorneys relied, in their defense
of Gallo et al.
in which Dr. Fischinger went about his task makes clear how perverse
was the entire effort, and how distorted an account the Fischinger
report provided regarding the so-called facts of the case. At the
outset, Dr. Fischinger posed a series of questions to Dr. Gallo,
questions that focused on demonstrably irrelevant non-issues, most
notably the alleged "other isolates" of Gallo et al. Based solely
on the responses of Gallo et al., Dr. Fischinger hurriedly wrote
his report, which the Subcommittee investigation found to contain
numerous incorrect, misleading claims (see below). Dr. Fischinger
took the remarkable step of requiring Dr. Gallo to certify in writing
that all the information contained in the report was correct and
supported by data.
completing his report did Dr. Fischinger write a super-confidential
memorandum to Dr. Gallo, in which he (Fischinger) required Gallo
to address "three major areas of oversight," one of which concerned
the central issue in the entire dispute, i.e., the question of possible
misappropriation of the IP virus. Regarding this issue, Dr. Fischinger
asked for a
statement ... that LAV was never used in any connection in ... the
isolation of the HTLV-IIIb line."
response to Dr. Fischinger's request concerning this major area
of oversight was a nonresponse, a transparent evasion of Dr. Fischinger's
request (see below, p. 47). Even Dr. Fischinger should have recognized
something was being withheld from him, something was amiss. But
Dr. Fischinger, so far as is known, did nothing. He permitted his
report to stand, a report containing the blanket assertion that,
no evidence that material from any outside laboratory including
the French was used in generating the HTLV-IIIb virus..."
Based on the
LTCB evasions and misrepresentations, HHS rejected IP's informal
challenge. The matter soon thereafter moved into formal legal proceedings.
Yet at the
very moment HHS was dispatching a September 6, 1985 rejection of
the IP demands, HHS officials were confronted with damning new evidence
that strongly challenged the claims of Gallo et al. On September
5, HHS officials traveled to the NIH where they were told by laboratory
chief Dr. Malcolm Martin about experiments performed in his laboratory
that showed the IP and LTCB viruses were generically identical,
with the LTCB virus descended from the IP virus, and not the reverse.
The following day, the same HHS officials traveled to the HHS Centers
for Disease Control (CDC) where they learned that the IP scientists
discovered HIV and made a blood test fully the equal of the LTCB
test, long before Gallo et al. But these dramatic revelations did
not in any respect alter HHS' course. In fact, HHS' only action
was to ask Dr. Gallo to provide a further response. Meanwhile, HHS
officials "deep-sixed" the extensive documentation they had been
given to substantiate the Martin and CDC conclusions (see below,
p. 47). Some of this evidence was withheld from the Subcommittee
until late 1993.
claims rejected, in the Fall of 1985, the IP attorneys filed a request
at PTO for an "interference" with the Gallo et al. blood test patent
(an interference is USPTO procedure for determining priority of
invention between two or more parties claiming the same patentable
invention). In addition, in December of 1985, the IP attorney's
filed a suit for breach of contract in the U,S. Court of Claims.
The trust of the interference request was that
the IP scientists
should have been awarded the U.S. patent on the HIV antibody blood
test, because they both isolated the virus and invented the blood
test long before Gallo et al. and because their patent application
clearly predated that of Gallo et al ....
The legal pleadings
submitted by attorneys defending Gallo et al. were packed with false
and misleading claims, hardly surprising, given their exclusive
reliance on information provided by the LTCB/NCI. The attorneys
argued, in the strongest terms, that the IP and LTCB blood test
viruses were distinctly, genetically different, e.g.,
evidence is clear that HTLV-III and LAV are not so similar that
HTLV-III can be the progeny of LAV" (Defendant's Reply to Plaintiffs
Memorandum in Opposition to Defendant's Motion to Dismiss the Complaint;
the inventorship of the HIV antibody blood test, HHS/DOJ attempted
to argue that the Gallo et al. test was a different invention from
that of the IP scientists ....
concerning the failures of candor and the duty of disclosure, the
HHS/DOJ attorneys argued this:
material or relevant was withheld from the ex-miner" (Opposition
of Gallo et al. to the Motion for Judgment of Montagnier et al.,
investigation showed that the HHS/DOJ legal arguments could not
be substantiated. The HHS attorneys themselves recognized that they
were on very thin ice. In closed door discussion with their counterparts
at DOJ, the HHS attorneys described their principal arguments as
a "weak thread to rely on" and "a two-edged sword."
HHS/DOJ arguments were further jeopardized in the Spring and Summer
of 1986, first with the public revelation of electron micrographs
of the IP virus, published by Gallo et al. as "HTLV-III," showing
the virus productively growing in permanent cell lines. (This, of
course, was the virus that Dr. Gallo had previously and repeatedly
asserted did not grow.) Then, during the Summer of 1986, PTO--having
finally comprehended how badly it had been misled--began to invoke
the IP work as prior art to Gallo et al, threatening to throw numerous
pending Gallo et al. applications into the ongoing blood test patent
interference. The documented content of an "off the record" conversation
between the PTO examiner and an attorney for Gallo et al.
summed up the
in the PTO [are] believing that HHS/NIH are withholding inform.,
i.e., that Montagnier may be the first inventor of most of these
cases and that Gallo did indeed steal from him .... "
these developments, in the Fall of 1986, HHS increased its efforts
to obtain a settlement of the French/American dispute. A settlement
was signed, in March 1987, but the settlement barely managed to
paper over the glaring unresolved issues, and it began to unravel
almost before the ink on the settlement was dry.
its best to cover up the wrong-doing. Meanwhile, the failure of
the entire scientific establishment to take any meaningful action
left the disposition of scientific truth to bureaucrats and lawyers,
with neither the expertise nor the will essential to the task. Because
of the continuing HHS cover-up, it was not until the Subcommittee
investigation that the true facts were known, and the breadth and
depth of the cover-up was revealed. This report describes the facts,
and how and why HHS went so badly wrong. [Emphasis added]
TO THE INVESTIGATION
to the Subcommittee's investigation, and to the OSI and OIG investigations
as well, were significant .... Documentary evidence was vital to
the investigation; however, systematic withholding of documents
was evident from the outset, on the part of both agencies and individuals.
Key documents frequently were withheld for prolonged periods, in
many cases, for years. Some critical documents known to exist were
never officially produced. Among the most noteworthy such instances
were the following:
least one incident of document destruction occurred during the
pendency of the Subcommittee investigation, at the NIH Office
of Scientific Integrity (OSI) ....
in the possession of key participants in the HHS defense of Gallo
et al. were claimed to be destroyed or lost. Former NCI Associate
Director Dr. Peter Fischinger, for example,
Hurricane Agnes flooded his home, with the consequent loss of
all relevant documents in his possession.
Lowell Harmison, formerly the Science Advisor to the HHS Assistant
Secretary of Health, upon his retirement from HHS in late 1987
removed several boxes of documents from his office over a weekend
with the assistance of the then-Deputy Assistant Secretary for
Health. When HHS learned of Dr. Harmison's surreptitious document
removal, it belatedly changed the locks on the door of his office
and conducted a perfunctory "investigation" (an HHS attorney telephoned
Harmison to ask him for an explanation). Harmison claimed that
he disposed of most of the documents he removed from his office
in the trash, and he asserted all his "official" correspondence
should be available through the HHS Executive Secretariat. No
such correspondence was ever produced for the Subcommittee. In
fact, in stark contrast to Harmison's top-level, central role
in the HHS defense of Gallo et al, only two documents bearing
his signature were provided to the Subcommittee.
substantial number of highly significant documents were either
withheld or heavily redacted before they were provided to OSI
by Dr. Gallo and his colleagues. As a consequence, OSI was seriously
misled concerning such significant matters as what experiments
were performed with the IP virus, how the putative LTCB prototype
HIV was "isolated," and when Dr. Gallo knew about these experiments.
critical sets of data never were produced to the Subcommittee
particularly egregious instance of document withholding at NIH
came to light in late 1993, when Subcommittee staff learned from
an outside source about the existence of a large cache of documents
at the NIH FOIA office. These documents, never produced to OSI,
the HHS Office of Inspector General, or the Subcommittee, included
a set of documents (the "Myers documents") showing that in 1987,
within days of the signing of the French/American settlement,
leading American scientists had concluded that Dr. Gallo's claims
for the origins of this "IIIb" virus amounted to a "double fraud."
The Myers documents
also showed that in early 1989, faced with the evidence, Dr. Gallo
was about to "throw in the towel" and admit publicly that the LTCB
and IP prototype viruses are genetically identical, with the LTCB
virus derived from the IP virus; At the last minute, Dr. Gallo reneged
on his commitment to make a public acknowledgment of the viruses'
identity, and a year later,
when the OSI
inquiry was underway, he asserted repeatedly that the viruses could
be genetically independent, and even if they were identical, the
"contamination" could have occurred at the IP, rather than at the
at least as great a challenge as documentary evidence, party because
memories of some witnesses had eroded, due to the passage of time.
At least as serious was the problem of willful forgetfulness and
obstructionism, of which the following instances are exemplary:
attorneys manifested particularly severe memory deficits. During
his October 8, 1992 interview by Subcommittee staff, HHS attorney
Richard Riseberg emitted a remarkable number of "I don't know,"
"I don't recall," and "I can't help you there" responses concerning
a number of critical events at which he personally was present
and NIH Directors Drs. Vincent DeVita and James Wyngaarden each
denied any significant responsibility for the defense of Gallo
et al. Yet each said the other was importantly involved ....
Drs. Wyngaarden and DeVita, as well as every other key player
at HI-IS, pointed to Lowell Harmison as the man in charge of the
U.S. defense of Gallo et al., particularly during the critical
early months of the French/American dispute. Attorney Richard
Riseberg described Harmison as the "linchpin" of the HHS defense
these characterizations, Dr. Harmison claimed little or no recollection
of most major elements of the French/ American dispute, particularly
his own role ....
III. THE LTCB
HIV BLOOD TEST PATENT
The April 23,
1984 Filing of a United States patent application for the HIV antibody
blood test of Gallo et al. was a defining event for HHS as well
as the LTCB scientists. The commercialization of the IP virus in
and of itself would violate the terms of the IP transfer agreement
that accompanied the virus sample (see p. 24 for further details);
the patent application further "upped the ante" dramatically for
all concerned ....
Gallo et al. Said in Their Patent Applications
On April 23,
1984, when Dr. Gallo and his associate submitted applications for
United States patents on their HIV blood test and a method for virus
production, they affirmed, under penalty of criminal prosecution
for making false statements, that they were,
original, first and joint inventors ... of the subject matter which
is claimed and for which a patent is sought .... "
al. affirmed, under penalty for making false statements, their
"... to disclose
information which is material to the examination of this application
Gallo et al. Withheld from PTO
... The attorneys
who prepared the April 1984 patent applications for Gallo et al.
told Subcommittee staff that they instructed Gallo et al. about
their duty of disclosure. Yet according to these attorneys, even
they were not told by Gallo et al. about the IP prior art, nor were
they told about the LTCB scientists' own work with the IP virus.
Both the attorney's and the PTO examiner told Subcommittee staff
that numerous aspects of the IP and LTCB work were material
to the claims of Gallo et al. and should have been disclosed
of and Benefit from the IP Scientists' Work With Their Virus:
The IP scientists were first to publish on the AIDS virus (Barre-Sinoussi
et al., Science, May 1983) ....
Gallo et al.
did not disclose any of the IP publications to PTO, save for a single,
misleading reference in one LTCB paper cited in one of the Gallo
et al. patent applications, a reference that implied the LTCB and
IP viruses were different. Neither did Gallo et al. disclose any
of the IP scientists' papers, presented at meetings which Gallo
and his colleagues attended. Consequently, the PTO examiner had
to discover them on her own. The IP publications unquestionably
were material to the Gallo et al. applications. In fact, when she
belatedly became aware of the IP publications, the PTO examiner
declared that both Barre-Sinoussi et al. and Montagnier et al. were
"prior art" to the blood test CIPs of Gallo et al. For this reason,
she repeatedly rejected every claim contained in these CIPs.
The PTO examiner
cited both sections 102[a] and 103 of 35 U.S.C. as the basis for
her rulings. Concerning claims in the Gallo et al. blood test CIP
applications, the examiner said the claims:
rejected ... as anticipated by or, in the alternative .... as obvious
over Barre-Sinoussi et al .... or over the disclosures of Montagnier
9/1983 .... " (2/11/86 PTO Office Action, Gallo et al., SN#635,610;
deemed to be drawn to subject matter which is the same as or substantially
the same as that taught by Barre-Sinoussi et al. or Montagnier
et al." (op. cit., p. 5).
rejected under 35 U.S.C. 103 as being unpatentable over Barre-Sinoussi
or Montagnier et al .... " (4/4/86 PTO Office Action, Gallo et
al., SN# 643,715; p. 9).
further said that
method taught by Barre-Sinoussi for the assay of LAV appear inherently
to anticipate or render obvious the claimed methods drawn to assay
of HTLV-III (op. cit. p. 9).
The PTO examiner's
realization of the significance of the IP scientists' work came
only after the Gallo et al. blood test patent had already been issued,
too late for the IP work to be cited against that patent. By August
1986, once an "interference" had been declared between the Gallo
patent and the IP blood test patent application, PTO was preparing
to either suspend all the pending Gallo et al. CIPs or incorporate
them into the interference. Either eventuality would have been significantly
damaging to both HHS' patent program and HHS' position in the French/American
occurred unbeknownst to the IP and its attorney's ....
Issuance of the Gallo et al. Patent
In May 1985,
the USPTO awarded a patent on the HIV antibody blood test to Dr.
Gallo and his colleagues. The Gallo et al. patent was issued in
record time, just thirteen months and one Office Action after it
was submitted. At the time the Gallo et al. patent issued, the IP
patent application, submitted over four months prior to the submission
of the Gallo et al. patent application, had not been touched ....
The differential handling of two applications for the same invention
has never been satisfactorily explained, the consequences in disadvantaging
the IP application are clear.
The IP application
was passed among four different examiners; consequently, the application
had never been "briefed," i.e., there was no PTO record of the IP
claims. When the PTO examiner of the Gallo et al. application conducted
an "interference search" just prior to issuing Gallo et al., she
found no record of competing claims. According to the examiner,
when she first saw the IP application, within two weeks of issuing
Gallo et al., she recognized immediately that PTO had "screwed
up" in issuing the Gallo et al. patent. The examiner told Subcommittee
staff she recognized that the Gallo and Montagnier inventions were
"directly related." The examiner also said that had she become aware
of the IP application during her examination of Gallo et al., she
would have suspended examination of Gallo et al. and "... would
have thrown them into an interference."
But by the
time the examiner saw the Montagnier et al. application, the Gallo
et al. patent had already been issued. Consequently the burden of
seeking an interference fell on the true inventors of the HIV antibody
blood test, Montagnier et al.
Report and the Executive Summary go on with meticulously documented
statements about the history of the Gallo case. The above constitutes
a sample of the ongoing text. I now jump to the concluding paragraphs,
B. The Subversion
of Science and Public Service
One of the
most remarkable and regrettable aspects of the institutional response
to the defense of Gallo et al. is how readily public service and
science apparently were subverted into defending the indefensible.
the significance of the subversion of public service in the cover-up,
it is useful to review the Guidelines of the Ethics Committee of
the Washington D.C. Bar Association concerning the roles of government
attorney's. According to the guidelines,
lawyer in a civil action or administrative proceeding has the responsibility
to seek justice and to develop a full and fair record, and he should
not use his position or the economic power of the government to
harass parties or to bring about unjust settlements or results."
(BC 7-14; p. 51)
although they focus on government attorney's, apply at least as
well to the NCI/HHS science administrators who played such a crucial,
"make-or-brake" role at the outset of the French/American dispute.
The deliberately negligent "fact-finding" conducted by these individuals,
combined with their deliberate suppression of incriminating evidence,
set the stage for everything that happened thereafter. But the attorneys
bear significant responsibility as well, for they clearly did not
seek diligently to "develop a full and fair record" of the facts
about the claims of Gallo et al.
HHS/DOJ officials and attorney's, once the dispute was under way,
deal responsibly with the accumulating evidence that there were
serious problems in the U.S. Government's claims. Instead, they
pushed on with their "litigation strategy," all the while adding
deception to deception, consuming untold resources and squandering
scientific and international good will. The fraud became self-perpetuating.
Defending the indefensible became a reflex, until ultimately, the
cover-up was so burdened with falsehoods that its collapse was inevitable.
HHS officials and attorneys should have recognized early on that
the falsehoods could not be indefinitely sustained. But HHS sought
only to "defend the position." HHS did not see the truth. HHS did
not honor the public trust.
to principles of responsible, ethical science was just as profound.
At a crucial point early in the LTCB's HIV research, international
politics and the technocrats committed to those politics virtually
took over that research, claiming the laboratory's putative accomplishments
as accomplishments of the United States administration and by extension,
the United States itself.
the LTCB's interests became the Government's interests; defending
the LTCB scientists' reputations and claimed accomplishments became
necessary for defending the honor of the United States. The defense
thus became a consuming effort for significant portions of the U.S.
was a costly, prolonged defense of the indefensible in which the
LTCB's "science" became an integral element of the U.S. Government's
public relations/advocacy efforts. The consequences for HIV research
were severely damaging, leading, in part, to a corpus of scientific
papers polluted with systematic exaggerations and outright falsehoods
of unprecedented proportions.
how far from the ideal the defense of Gallo et al. led the scientific
community, it is useful to note the words of two esteemed scientists,
Drs. John Cairns and Paul Doty:
is the pursuit of a truth that is external to our wishes. This truth
is quite unlike the verdict of a court of law because it does not
depend on advocacy" (John Cairns; Nature, 352, 1991, p. 101.)
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 .... As a result, the scientific community may already
be experiencing a gradual departure from the traditional scientific
standards .... 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." (Paul Doty; Nature, 352, 1991; p. 184).
be no better description of the disastrous consequences of the U.S.
Government's defense of Gallo et al.
next reproduce extracts from the documentation itself, that is quotes
from the main participant, Gallo, and some other people. These excerpts
from the Executive Summary and Staff Report reflect some of the
more notable of the numerous unsubstantiable or false claims, denials,
and shifting stories relating to major issues considered by the
Subcommittee's investigation. These excerpts
meticulously how U.S. Government officials and attorneys adopted
and promulgated, on behalf of the United States Government, unsubstantiable
or false claims concerning certain putative accomplishments of Dr.
Robert Gallo and his associates at the National Cancer Institute
(NCI) Laboratory of Tumor Cell Biology (LTCB). S.L.]
FROM THE STAFF REPORT
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
Selection by Serge Lang
that Gallo et al. Isolated HIV in 1982
were a central element of the U.S. Government's defense of the blood
test patent of Gallo et al., because scientists at France's Institut
Pasteur (IP) developed and applied for a patent on the HIV blood
test months before Gallo et al did so. The Staff Report documents,
with quotes from the principals, that the claims of 1982 HIV isolates
"were not true" (Executive Summary, p. 9). I reproduce some of these
al. in AIDS: Etiology, Diagnosis, Treatment and Prevention, 1985,
p. 34: 'The first HTLV-III [Gallo's name for HIV] isolates
were obtained in this laboratory in November 1982, and HTLV-III
was subsequently isolated from approximately 100 patients with AIDS
or from healthy individuals at risk for AIDS." (Staff Report,
Gallo, et al., PNAS 82, 1985 pp. 5530-34: "Since the
fall of 1982, independent isolates of HTLV-III have been obtained
in this laboratory ... from 101 AIDS and ARC patients and healthy
donors at risk for AIDS." (Staff Report, p. 12)
of Gallo et al. to the Motion of Montagnier et al. for Judgment,
November 1986, Interference Proceeding of the U.S. Patent and Trademark
Office (PTO), p. A8: "In late 1982-early 1983,
[Gallo] obtained a number of viral isolates including HTLV-III.("Executive
Summary, p, 54)
Statement of Gallo et al., PTO Interference, 1986: "The first
written description of the invention [the Gallo et al. HIV blood
test] was made on December 15, 1982." (Staff Reporters, p.
l(b), Subsequent Shifts and Contradictions
Office of Scientific Integrity [OSI], 16 May 1990, transcript p.
110): "... you are asking me to defend something that I don't--I
don't claim we had the cause of AIDS discovered in February 1983
or December 1982 "(Staff Report, p. 18)
to the Chicago Tribune, published 19 November 1989: "The
December '82 data is really marginal .... The data were equivocal.
At the time they were not even real data .... The cells died. I
can't make any claim for that. Some people would." (Staff
Report, p. 19)
interview, 25 May 1990, transcript pp. 26-27: 'I never made
a claim in the literature for December '82 samples .... We didn't
publish these claims in any publication. I am a scientist. I
go by what I publish." (Staff Report, p. 20)
interview, 16 May 1990, transcript pp. 103-104: [Concerning
the PNAS claims cited above] "For all of '82? ... Can I have
the reference? I would like to see that in writing if I said that
.... I don't believe I would have any reason to say that in PNAS.
I mean, it doesn't sound like me." (Staff Report, p. 20)
an interview with the Subcommittee Staff, Executive Summary p. 9):
"No one believed we really had that many isolates .... No one
believed we really meant that .... "
II(a). Claims that the IP Virus Did Not Grow at the LTCB
the Executive Summary: "The LTCB scientists ... performed
all of their seminal experiments ... with the IP virus, first under
its own original name .... then under two different names .... "
(p. 4) "... the IP virus, under its own name, grew at least two-to-three
months at the LTCB" [beginning in the Fall of 1983] (p. 25).]
Ian Munro, editor of The Lancet, 6 March 1984: [Referring
to the IP virus] "... their virus (viruses) have never been
characterized nor transmitted permanently to recipient target
cells .... " (emphasis in original) (Staff Report, p. 37)
Gallo et al., Science, 225, May 1994, p. 500: [LAV] "...
has not yet been transmitted to a permanently growing cell line
.... " (Staff Report, p. 37)
IP scientist Jean-Claude Chermann, 24 August 1984: "The sample
of the virus you sent us the first time had, upon arrival no detectable
virus..." (p. 1) and "... we did not grow LAW (p. 3). (Staff
Report, p. 38)
in Science, 230, November 1985, p. 642: [Referring
to the IP claim that "Gallo's group somehow grew the French isolate]
"Gallo indignantly disputes this allegation on several counts,
including the fact that the ... amount of virus Montagnier sent
would not have been sufficient to infect a cell line." (Staff
Report, p. 38)
in U.S. News and World Report, 13 January 1986: [Referring
to speculation that "Gallo may have mistakenly contaminated his
experiments with the French virus"] "That's the height of outrage,"
responds Gallo, who adds that "it was physically impossible" to
grow the particles of virus sent by Montagnier. (Staff Report,
Dr. Peter Fischinger, Associate Director of NCI, 19 August 1985:
[The first virus sample sent from the IP to the LTCB] "did not
contain detectable virus." (Staff Report, p. 157)
by Gallo et al. to the Motion for Judgment of Montagnier et al.,
PTO interference, November 1986, p. A12: [Concerning the
same virus sample] ."..no virus was found in this sample and
it appears that virus initially present may have been killed in
transit." (Executive Summary, p. 54)
II(b). Shifts and Contradictions
interview, 18 July 1990, transcript p. 85: [Concerning the
first virus sample sent from the IP to the LTCB, the sample Dr.
Gallo told NCI officials in 1985, "did not contain detectable
virus "... we knew we had something there and so we saved it." (Staff
Report, p. 40)
declaration, PTO Interference, November 1986: [Concerning
the second virus sample sent from the IP to the LTCB] "Dr. Popovic
did succeed in temporarily transmitting LAV to a cell line called
HUT-78 and one other T-cell line. However, both transmissions were
only temporary in nature" (Executive Summary, p. 54)
interview, 8 April 1990, transcript p. 25: [Concerning the
second set of virus samples sent from the IP to the LTCB, the samples
whose growth Dr. Gallo asserted, in 1986, were "only temporary in
nature"] "The growth was significant and continuous." (Staff
Report, p. 28)
interview, 16 May 1990, transcript p. 87: "... there has been
confusion in the response of what we did to LAV. In my response
during the passionate period... 'Oh we never grew LAV' and of course
we did grow LAV." (Executive Summary, p, 26)
interview, 25 May 1990, transcript p. 13: "There is a point
where I say I didn't grow LAV. And, of course, LAV was grown ....
Quite frankly, it wasn't so germane to me at the time and I was
just anguished as to what was coming out of the newspaper. At that
moment bombs were going off." (Executive Summary, p. 26)
Obscuring the Origins of the First HIV-Permissive Cell Line
the Staff Report:. "Dr. Gallo's discovery of how to grow
the AIDS virus in quantity occurred when Dr. Popovic [one of
the LTCB's top HIV researchers] used another scientist's cell line
[HUT-78] ... to grow another scientist's virus isolate .... Gallo/Popovic
gave the cell line a new name 'HT/H9' ... giving no credit to
the true originators, and thereby tacitly as well as explicitly
claiming the 'discoveries' as the LTCB's own." (p. 53)]
at the 5 April 1984 Beecham "Symposium on Infective Agents and Their
Effects": "The breakthrough occurred for us when we learned
how to transmit this [the AIDS virus] in a particular cell line
developed in our lab ... a new line." (Staff Report, pp. 54-55)
Report, NCI's official response to the blood test patent dispute,
certified by Dr. Gallo as true and supported by data, p. I0: [Referring
to the original HUT-78 cell line] "...which is a relative of the
HT cell line developed by Dr. Gallo "
(Staff Report, p. 166)
from Popovic to Gallo provided to NCI/HHS officials as part of the
response to the blood test patent dispute, 6 September 1985: "The
detailed characterization of the clone, H9, is being prepared for
publication and its comparison with HUT-78 cells ... will soon be
performed. In any case, why would anyone care?" [The phrase "why
would anyone care?" was added to the memorandum by Gallo himself](Staff
Report, p. 57)
in Science, 248, 1990: "I don't consider it so brilliant.
In my mind, there is no credit for a cell line. If it happens by
accident you have a cell line, so freaking what (p. 15001 .... The
fact is I never really thought it was important. And quite frankly,
I still don't and I don't understand the people who do." (p. 1507)
(Staff Report, p. 55)
III(c) Comments by Other Scientists
Sabin, letter to Science, 249, 1990, p. 466: [Referring
to the recently published finding that H9 was identical to HUT-78]
"This is not a trivial or irrelevant matter, as it was called
by Gallo and Popovic, because the use of such uncontaminated, continuous
lines of human T4 lymphocytes was crucial to the regular isolation
of the new retrovirus from patients with AIDS and to the development
of the antibody blood test by which it was possible to establish
the etiological association of the virus discovered by Montagnier
and his colleagues (Staff Report, p.131)
Panel statement, 19 February 1992: "... the so-called HTLV-III
virus was thus established and introduced to the world with no reference
to or discussion of two crucial facts ... the cell line utilized
[HUT-78] was one that had been obtained from the Minna laboratory
.... Although others could have obtained HUT-78 from the ATCC ...
the essential identity of HUT-78 with H9 had been effectively obscured."
(Staff Report, p. 55)
Use of Cell Lines and LTCB Reagents
Gallo made the cell line in which he was growing the virus available
to some scientists, he either withheld it from others, or imposed
restrictions. According to the Staff Report: "The selective withholding
of the H9 cell line and the restrictions placed on its use compounded
the harm from the failure of Gallo/Popovic to disclose the true
origins of the cell line, i.e. HUT-78, at a time when ready availability
of the first published cell line permissive for HIV might have significantly
advanced AIDS/HIV research." (p. 131) "... Dr. Gallo went to considerable
lengths to prevent scientists whom he knew had obtained the
IP virus from using 'his' virus and 'his' cell line...to make their
own comparisons" (Executive Summary, p. 43).]
included in the standard materials transfer agreement prepared by
the Gallo laboratory in Spring 1984: "Work performed
will be on a collaborative basis with Dr. Gallo and his laboratory
unless stated otherwise." (Staff Report, p. 127)
included in a special LTCB transfer agreement imposed on Harvard
University's Dr. James Mullins, 1984: "Use of H9 will
be limited to my immediate laboratory for the specific purpose of
transfection of CTV and HTLV-1 DNA. No other experiments will be
carried out with this cell line without prior discussions with Dr.
Gallo." (Staff Report, p. 131)
included in a special LTCB transfer agreement imposed on Dr. William
Haseltine, 1984: "Work performed will be on a collaborative
basis with Dr. Gallo, Dr. Popovic, Dr. Wong-Staal, and their colleagues
(to be specified by them) for the specific purpose of studying expression
of HTLV--LTR linked genes in these cells. No other experiments should
be initiated with these cells without prior discussion with the
above named people." (Staff Report, p. 132)
included in special LTCB transfer agreements imposed on scientists
at the Centers for Disease Control [CDC] and on NIH laboratory chief
Dr. Malcolm Martin, 1984: "Work with HTLV-III will not be published
without prior approval by Dr. Gallo" and "Reagents will not be used
in comparisons with other viruses." (Staff Report, p. 132)
unique to the special LTCB transfer agreement imposed on scientists
at the CDC, 1984: [Referring to LTCB cell lines] "They
will only be used for seroepidemiologic studies and blood bank assays."
(Staff Report, p. 132)
Dr. Malcolm Martin, 22 June 1984: [Concerning the uninfected
H9 cell line] "... I do not think it would be appropriate for
you to put the French isolate in them. That is for them to do in
collaboration with me and my co-workers and is ongoing." (Staff
Report, p. 130)
IV(b). Comments by Other Scientists
Fischinger, interview with Subcommittee staff: "I wouldn't
do it, but Bob must answer for himself." (Staff Report, p.
Wyngaarden, former Director of NIH, interview with Subcommittee
Staff: "Clearly inappropriate." (Staff Report, p. 136)
de Vita, former Director, NCI: "All restrictions are antiscience
.... I think it's terrible." (Staff Report, p. 136)
Panel Report, 19 February 1992, p. 3: "We consider failure to
distribute uninfected H9 cells freely after publication of the article
by Popovic et al. to be essentially immoral in view of the growing
seriousness of the AIDS epidemic." (Staff Report, p. 131)
V(a). Genetic Identity of the IP and LTCB Viruses
the Executive Summary, p. 8: "In June of 1984, the LTCB
scientists began a series of ... genetic comparisons of several
HIV isolates, including LAV and 'IIIb'. The results showed that
all the isolates were clearly different from each other, with one
exception-the 119 and LTCB prototype viruses--which were virtually
identical.., there could be no question but that the IP virus was
the original virus, i.e., that 'IIIb' came from LAV, and not the
Gallo ... devised a plan to make it appear that the French, in fact,
had appropriated the LTCB virus .... When Dr. Montagnier
vehemently objected and would not acknowledge the 'reverse contamination'
given that the LTCB scientists had LA V long before the IP scientists
received 'IIIb'), Dr. Gallo switched to the argument that the viruses,
although very much alike, were genuinely independent."]
Report, 27 August 1985: 'There is no evidence that material
from any outside laboratory including the French, was used in generating
the HTLV-IIIb virus" (p. 3) and "It is clear that LAV was not used
in generating the HTLV-IIIb virus strain advertently or inadvertently."
(p. 8) (Staff Report, p. 166)
in Science 230, 1985, p. 642: [Concerning the claim
by the Institut Pasteur that Gallo's group somehow grew the French
isolate] "Gallo indignantly disputes this allegation on several
counts, including the fact that the viruses are not identical
.... " (Staff Report, p. 38)
in the Wall Street Journal, 16 December 1985: [Concerning
the allegation that Dr. Gallo misappropriated the French virus and
presented it in his work, which later was patented] "Dr. Gallo
refutes this, saying that the LAV and HTLV-III strains, although
related, aren't identical .... Besides, the single LAV sample was
too small to be of practical use, he argues" (Staff Report,
Motion for Summary Judgment, II June 1986, U.S. Court of Claims
pp. 8-9: "Neither of these inventions [the Gallo et al. blood
test and cell line] depended on or is derived from LAV isolates
of the virus that is responsible for AIDS were available from many
sources, and in fact, it was from these independently established
isolates that HTLV-III was found." (Executive Summary, p.
in Opposition to Defendant's Motion for Summary Judgment, U.S. Court
of Claims, 8 April 1986, p. 6: "The scientific evidence is clear
that HTLV-III and LAV are not so similar that HTLV-III can be said
to be the progeny of LAV," (Executive Summary, p. 55)
Appellee the United States, U.S. Court of Claims, 22 May 1986, p.
4: "Continuing research revealed that LAV and HTLV-III were two
different isolates of the AIDS virus." (Executive Summary,
Attorneys in the U.S. Court of Claims, Oral Arguments, 22
May 1986: " there are significant differences between the structure
of HTLV-III[b] and LAV and you just can't say that HTLV-III is LAV
by another name." (Staff Report, p. 213)
Appellee the United States, U.S. Court of Claims, 13 November 1986,
pp. 4-5: "... Pasteur's statement that '[It] appears that Dr.
Gallo and certain of his colleagues essentially took LAV, renamed
it HTLV-III and the [sic] claimed and exploited it as their own'
... is an outrageous attempt to impugn the reputation of one of
the world's foremost virologists and his coworkers." (Executive
Summary, p. 56)
Gallo et al., unpublished manuscript prepared after the above-mentioned
experiments were performed, 1984: "LAV and HTLV-III [including
'IIIb"] are independent isolations of the same virus." (Staff
Report, p. 117)
Gallo, Wong-Stall et al., Nature, 313 (1985), pp. 636-637:
"HTLV-III[b], LAV, and ARV [another early HIV isolate] are variants
of the same virus ... the closer similarity of the LAV DNA sequence
to that of HTLV-III might be because the individuals from whom these
isolates were derived acquired the virus at a similar time and place."
(Staff Report, p. 166)
statement, 17 April 1989, never published: "Can we conclude
... that HTLV-IIIb and LAVB BRU did indeed originate from the same
individual? If that is indeed the case, it would only have resulted
from a mix-up in my laboratory when the LAV from Luc Montagnier
was temporarily growing along side the other isolates we had obtained.
We certainly cannot rule this out, particularly since we and, I
am told, many other investigators have often experienced the phenomenon
of laboratory contamination of HIVs ... I do ... think it is necessary
as a result of the data compiled in this book to acknowledge the
distinct possibility that HTLV-IIIb and LAV BRU are the same isolate."
(Staff Report, pp. 264-265)
Myers, 5 April 1990:2"I
have wanted to tell you for some time--that you were certainly right,
and I should have listened to you ... as early as 1984, I told her
[a reporter for Science] IIIb could be a contaminant of LAV. Because
of everything else we did and because of other isolates and because
of the help I gave Montagnier early on, I just could not believe
anyone would really care." (Staff Report p. 267)
Scientific Statement" to OSI, 6 April 1990: "With time and more
sequences available the relative similarities of this pair (LAV
and IIIb) remains unusual but not unique." (Staff Report p.
Interview, 8 April 1990, transcript p. 34: "Shortly after our
papers appeared in May '84, three of these isolates ... were analyzed
and shown to be distinct from ... each other by restriction endonuclease
analyses. RF, MN, and JS [the three LTCB isolates] were also shown
to be very different from LAV, but IIIb was similar to LAY." (Staff
Report p. 102)
Interview, 11 April 1990, transcript p. 82: "I'm interested
in a vaccine and in curing the disease. I'm interested in basic
science and how the virus works. Do you think I'm going to get back
there in the mud of whether IIIb and LAV came from this lab or the
other lab when I have all kinds of other isolates and things are
moving like a bullet? And I want to be worried about that, and did
it happen in my lab, or their lab . . . I mean, who bloody cares?"
(Staff Report, p. 267)
Interview, 11 April 1990, transcript p. 71: "I have felt
it is an irrelevant question, for the most part ... scientifically,
ethically, medically and historically, because there are so many
other isolates and if anybody had half as many in tissue culture
within the next year I would be surprised, so I've never felt it
to be an important question. It's only in this context of the questioning
that I'm getting
here that it becomes important or for politics that have been played
in newspapers .... " (Staff Report, p. 267)
Interview, 11 April 1990, transcript p. 72: "... I would
conclude that there can't be a conclusion today .... I don't think
we can make any conclusive statement .... Also, please keep in mind
that though I said if this possibility or probability exists ...
I didn't tell you where it [contamination] happened with certainty
also. I believe that question is open, no matter what information
you may have .... " (Staff Report, p. 266)
Virus Hunting, 1991, pp. 197-199: [Referring to experiments
made in 1984] "About this time (June-July) Wong-Staal [Dr.
Flossie Wong-Staal, another LTCB scientist] compared the genetic
material of LAV with our isolates ... we learned that there was
considerable variation in the viral genome when comparing one isolate
to another .... Last and most unsettling, we discovered that one
of our own HTLV-3B isolates was much closer to LAV than was typical
of our other isolates .... Practically all were genetically different
from one another. Yet LAV and our IIIb isolate(s) were distinctly
close to each other." (Staff Report, p. 103)
IP scientist Dr. Simon Wain-Hobson, 24 July 1991: [Referring
to the 1984 experiments described immediately above] "Our conclusion
was that we had a serious contamination problem .... " (Staff
Report, p, 101)
by Gerald Myers
Myers to Dr. John LaMontagne et al., 8 April 1987, p. 4: "...
it is the astonishing and unforeseen variation of the virus, which
exposes the fraud .... I suggest that we have paid for this deception
in more than the usual ways. Scientific fraudulence always costs
humanity ... but here we have been additionally misdirected with
regard to the extent of variation of the virus, which we can ill
afford during the dog days of an epidemic let alone during halcyon
times." (Staff Report, p. 263)
Myers to Gallo, 20 September 1988, p. 1: "From our earliest
tree analyses, it was patently evident that the IAV and IIIb viruses
had to have had a recent common ancestor .... By including all of
the available gene sequences in a single analysis for the IIIbs,
it is actually possible to define the branching order
of the variants
to a high degree of statistical precision. There is no doubt but
that it shows the LAV source of the IIIb viruses: the NL43 clone
of the [LAV] BRU isolate is the oldest sequence; the published BRU
follows it; the IIIbs follow thereafter . . . " (Staff Report,
VI. Responsibility for False and Misleading Statements
the Executive Summary, p. 54: "The U.S. Government pleadings,
particularly those in the Claims Court and at PTO, contain numerous
misleading claims. They also reflect numerous material omissions.
The misinformation and material omissions are traceable directly
to documents and statements prepared by Dr. Gallo and his LTCB colleagues,
including numerous statements in the scientific literature, and
documents and statements originating with Dr. Gallo's NCI and HHS
superiors, including but not limited to Drs. Peter Fischinger and
of accuracy and reliability of the scientific content of the "Fischinger
Report," August 1985: "The enclosed attachment ... has been
reviewed by me relative to the fidelity of specific information
presented as well as the accuracy of its interpretation. These data
are substantiated by entries in the notebooks, as well as by other
records emanating from the Laboratory of Tumor and Cell Biology,
NCI." (Staff Report, p. 161)
with Subcommittee staff, July 1993: "I didn't read it [the Fischinger
Report] as carefully as you might think." (Staff Report, p.
Fischinger, interview with Subcommittee staff, 1993: "My major
point of discussion was Bob. No question about that. In terms of
him trying to organize or find some of the data, some of the things
that were going. I was listening to him as the point person ....
I had a sense,
at least from my perspective, there is laboratory data. Bob sort
of swears that this is the way it is, and the laboratory data sort
of generally support it, as opposed to no data. Then that's going
to be his, sort of, ultimate responsibility. That was my feeling.
So I would rely, myself, from a scientific point of view, in terms
of what they did in the lab, he has the best knowledge, he should
have the control of it.
was that Gallo has to go, and demonstrate this, and he has to defend
what he has done, he has kind of sworn to the fact that he did what
he did, and the fact that this is something that could stand in
terms of his own laboratory's merit. And he sort of claims it even
in terms of specifics, and has an argument that I could sort of
believe in that is strong enough.
I said, 'Look,
this is what you did. This is the summation of [what] you had said
in your laboratory data to prove it. And let's take it from there.'"
(Staff Report p. 160)
Interview, transcript pp. 99-109: "... I was asked by
the United States Government to draw a lineage to the first time
we detected this virus to show lineage of our work. You see what
has happened as a scientist I am being put into a legal position,
which I am not used to ... when I am asked to go back and draw lineage
to our first experiments that have positive indications, that is
what I did for the government .... But that wasn't for me to get
scientific credit. Just suddenly I am in a legal thing. I am back
to a morality ethics thing issue." (Staff Report, p, 17)
attorney Joseph Onek, OSI interview, 3 August 1990, transcript p.
153: [Concerning Gallo's sworn declaration] "I should
point out that, of course, this is a statement like any affidavit,
but I am sure was prepared by lawyers, not by Bob .... "
(Staff Report, p. 210)
motion for extension of deadline, PTO interference, 30 June 1986,
pp. 3-5: 'The complex nature of the subject matter of this interference
and the voluminous experimental work which led to the development
of the patented invention [the Gallo et al HIV blood test] also
require the personal participation of Dr. Robert C. Gallo .... Only
Dr. Gallo is thoroughly familiar with the records relating to these
developments ... the personal assistance of Dr. Gallo is of the
utmost importance in pursuing these investigations." (Staff
Report, p. 207)
Staff Report concerning an interview of a patent attorney with the
staff, p. 19: "Another outside patent attorney said that for
the most part, he had to rely on interviews with Dr. Gallo or his
associates as a source of information. The attorney said he asked
the LTCB scientists, 'Do you have data to support these claims?'
and, 'Sometimes the data were provided; often they were not.' But,
said this attorney, 'I never had any reason to doubt what I was
with significant pieces of data that contradict the claims of Gallo
et al., this attorney responded, 'You're telling me things I know
attorney, interview with Subcommittee staff: "Here's this guy,
almost a Nobel Prize winner, you walk in his office and see all
these awards all over the walls--if he tells us he did something,
are we going to question it?" (Staff Report, p. 19)
attorney, interview with Subcommittee staff: "Believe me, I
didn't know enough to lie." (Executive Summary, p. 53, Staff
Report p. 19)
LISTING OF DOCUMENTS DELAYED OR NEVER PROVIDED TO THE SUBCOMMITTEE
BY HHS OR DOJ
Executive Summary, p. 14. "In addition to the documents
listed below, a substantial number of significant documents were
altered and/or redacted before they were provided by Gallo et al
to OSI" and hence to the Subcommittee.]
OSI staff notes from the Gallo investigation--destroyed in 1992
by order of then-OSI Director Dr. Jules Hallum, despite an outstanding
Subcommittee document request. Executive Summary, p. 14)
All documents from the office of Dr. Lowell Harmison, formerly
HHS Science Advisor to the Assistant Secretary for Health and a
major player in the HIV blood test dispute. By his own admission,
the documents were removed by Dr. Harmison and allegedly discarded,
on the occasion of his retirement from HHS in late 1987. Executive
Summary, p. 14)
All documents from the office of C. McLain Haddow, formerly
Chief of Staff to HHS Secretary Margaret Heckler and a major player
in the early days of the blood test dispute. Haddow told Subcommittee
staff he left all his documents in his office. Only a single Haddow
document was provided to the Subcommittee by HHS. (Staff Report,
All attorneys' notes from the U.S. Department of Justice.
(a) LTCB data from the initial 1984 experiments showing the
IP and LTCB prototype HIV isolates were genetically identical; (b)
LTCB data associated with the unpublished 1984 Lancet manuscript
that reported the IP and LTCB isolates were "independent"; (c) documents
associated with the LTCB scientists' 1984 review of the Bryant et
al. manuscript that reported the genetic identity of the IP and
LTCB HIV isolates. (Executive Summary, p. 15; Staff Report,
pp. 92, 118)
nearly one year. Numerous highly significant documents generated
by or previously in the possession of former NCI Associate Director
Dr. Peter Fischinger, including documents showing how NCI misled
then-Assistant Secretary of Health, Dr. Edward Brandt, concerning
the identity of the IP and LTCB HIV prototype isolates. The "Fischinger
documents," known by the Subcommittee to exist, had been provided
by NIH to a pharmaceutical firm in connection with a 1992 lawsuit.
The documents were not provided to the Subcommittee despite repeated,
specific requests. They finally were given up just hours before
the Subcommittee staff visited the NIH campus to interview witnesses
about the "missing" Fischinger documents. (Executive Summary,
p. 41; Staff Report, p. 112)
nearly two years. Peter Fischinger's August 1985 "Major Areas
of Oversight" memorandum to Dr. Gallo, showing Dr. Fischinger's
concern with, among other things, the failure of Gallo and his associates
to confirm they did not us LAV in isolating the LTCB's putative
prototype virus "IIIb." (Executive Summary, p. 46; Staff Report,
nearly two years. Memoranda to Dr. Harmison from NIH laboratory
chief Dr. Malcolm Martin reporting Dr. Martin's laboratory data
that pointed to the strong probability the IP and LTCB prototype
HIV isolates were genetically identical, with the putative LTCB
isolated derived from the IP, and not the reverse. One of these
vitally important memoranda was located in Dr. Gallo's files, over
three months after Dr. Gallo signed an affirmation that he had provided
all responsive documents to the Subcommittee and asserting that:
"I really do not know what Mr. Dingell is referring to in terms
of documents not received relating to the patent." (Staff
Report, p. 176)
nearly two years. The "Myers documents," dating from 1987-1990,
showing proof of the genetic identity of the IP and LTCB prototype
HIV isolates. (Executive Summary, p. 15. Staff Report, p.
nearly two years. All documents relating to Dr. Bernadine Healy's
committee of "wise men," by which Dr. Healy attempted--and mostly
failed--an end run of the "Richards committee." (Executive
Summary, p. 57)
§3. Subsequent Developments
Tribune reported on the Dingell Staff Report ("In the Gallo
case, truth termed a casualty," 1 January 1995, p. 1), and followed
this article by a scathing editorial "Defending the indefensible
Dr. Gallo" (6 January 1995). A few days later, I received a fax
from Gallo stating: "In view of your continued assassination of
my character and the enormous amount of time you have put into distributing
unfair and ridiculous [sic] attacks on me, I trust that in fairness
you will circulate these two enclosures (3 pages which follow),
written by Bernadine Healy and my lawyer, Joseph Onek." I did circulate
these documents, which I reproduce below, together with replies
which Gallo did not send to me but which I received directly from
the parties involved. I also included samples of false statements
by Gallo and his lawyer (vide supra).
LETTER FROM BERNADINE HEALY
to the Chicago Tribune
19 January 1995
No conspiracy in HIV controversy
his Final spasm as outgoing chairman of the Energy and Commerce
Committee, Rep. John Dingell (D-Mich.) heaved another package of
fabrications and distortions. These latest accusations arrived in
an allegedly unauthorized, "leaked," secret draft report on a three-year
investigation of a controversy surrounding the 1984 discovery of
the AIDS virus (HIV) reported by the Tribune Jan. I.
One hopes this
marks the end of Dingell's deluded notions of a multi-administration
conspiracy to protect Dr. Robert Gallo, one of the discoverers of
HIV who also developed the blood test for HIV.
taxpayer expense, Dingell has pursued Gallo and attacked anyone
who has refused to join in his crusade.
chairman first accused me, as then-director of the National Institutes
of Health, of "replacing" an employee of the NIH's Office of Scientific
Integrity (OSI) who wrote a report that was "sharply critical of
was never replaced. On the contrary, before I arrived at the NIH,
she requested and was given a new job in an unrelated department.
She was also given leave at that time to complete her work on the
Gallo case. I did ask her to revise the amateurish and poorly written
report for style and structure, but when she complained that revision
would change the meaning, I withdrew my request immediately. I subsequently
accepted the employee's report which ironically, though critical
of some of his actions, had always exonerated Dr. Gallo of misconduct.
former chairman contends that I "bypassed" the "conclusions" of
an advisory committee in accepting the OSI report that exonerated
Dr. Gallo. In fact, I was presented with several non-binding recommendations
of advisory groups, all of which advised acceptance of the report
except one. The one contrary recommendation came from a committee
that refused to consider evidence or testimony from the accused.
I easily could
have ignored all other findings in favor of the advice from the
one flawed advisory committee. Instead, I made an independent judgment
that, after careful review, seemed to me to be correct.
to be a pawn in the former chairman's smear campaign prompted further
false accusations. An example is the third charge in his report,
his invention of a conversation in which I told him that I felt
I had to "save Bob [Gallo]." I never made such a preposterous statement.
As the head
of an agency that was a frequent target of Dingell's witch-hunts,
I saw first-hand the abuse of power by a long-time committee chairman
and his staff acting as secret police, prosecutor, judge and jury
under the old House rules. Americans would be shocked to learn of
the clandestine tape recordings, document theft, threats, foul-mouthed
verbal rantings and abusive closed-chamber interrogations of the
former chairman and his staff of over 100.
the Freedom of Information Act and the laws against libel and slander,
Dingell and his staff operated in virtual secrecy, withholding any
documents that displayed its methods of operation or contradicted
its fabricated story line. This gave them carte blanche to
make reckless and unsupported statements about people or institutions.
Let the actions
of Dingell and his bloated staff be a memorial to what went wrong
with Congress after 40 years of single-party rule.
STAFF, CLEVELAND CLINIC FOUNDATION
FORMER DIRECTOR, NATIONAL INSTITUTES OF HEALTH
REPLY TO BERNADINE HEALY
Chicago Tribune, 12 February 1995
Report found scientific misconduct
Healy's January 19, 1995 letter concerning the congressional subcommittee
draft staff report in the Dr. Robert Gallo case was characteristically
inconsistent with the facts. As former NIH and Subcommittee investigators
in this case, we write to set the record straight.
orders for changes in the NIH Gallo report did not bear merely on
the "style and structure" of the report. Independent memoranda to
Dr. Healy from the then-Director of the NIH Office of Scientific
Integrity (OSI) and the chief investigator (supported by the then-Deputy
Director of NIH) protested that Dr. Healy's ordered changes, "would
be damaging and enervating" and would "significantly vitiate the
findings" of the Gallo report.
Dr. Healy's claim, the NIH Gallo report did not "always exonerate[d]
Dr. Gallo of misconduct." The penultimate version of the draft report
found Dr. Gallo guilty of scientific misconduct (in the controversy
surrounding the discovery of the AIDS virus), while the final version
of that report found that Dr. Gallo "created and fostered conditions
that gave rise to falsified/fabricated data and falsified scientific
reports" and Dr. Gallo's actions "warrant significant censure."
Based on these
findings and other contemporaneous situations of wrongdoing in the
Gallo laboratory, Dr. Healy's predecessor decided to initiate a
formal evaluation of Dr. Gallo's fitness to serve as an NIH laboratory
chief. These plans, of course, were preempted by Dr. Healy's arrival
Dr. Healy did
indeed replace the NIH chief investigator in the Gallo case, ordering
that the investigator be "reined in" and "make no further decisions"
in the case. Moreover, Dr. Healy ordered an investigation
of the chief
investigator herself, an investigation that the then-OSI Director
described in memoranda to NIH attorneys and Dr. Healy herself as
"improper" and "a threatening intimidation."
advisory committee" was in fact a panel of distinguished scientists
nominated by the National Academy of Sciences to oversee the NIH
investigation. Contrary to Dr. Healy's assertion, this committee
examined extensive evidence submitted by Dr. Gallo and his
her implication that partisan politics produced her stormy relationship
with the subcommittee, Dr. Healy seems to have forgotten just how
bipartisan the subcommittee was in its dealings with her. During
the subcommittee's August 1991 hearing into Dr. Healy's firing of
the Gallo chief investigator, as well as Dr. Healy's mishandling
of a misconduct investigation at her own Cleveland Clinic Foundation,
Rep. Thomas J. Bliley (R-Va.), then the ranking Republican on the
subcommittee, observed that Dr. Healy's mishandling of the Cleveland
Clinic investigation ."..raises questions about Dr. Healy's willingness
to vigorously pursue allegations of scientific misconduct .... "
In short, contrary
to her mutterings about "single-party rule," Dr. Healy's adversarial
relationship with the Subcommittee was entirely of her own making.
Peter D. H.
(former investigator on the Subcommittee on Oversight and Investigation)
Suzanne W. Hadley, Ph.D.
(former OSI Deputy Director and chief investigator of the NIH Gallo
investigation, subsequently an investigator with the Subcommittee
on Oversight and Investigations)
Vol. 21, No. 5, 3 February 1995
Letter to the Editor
Gallo Attorney: Subcommittee Report Full of Errors, "Drivel"
To the editor:
It would require
a volume to respond fully to all the errors in the draft report
on the AIDS blood test patent as described in The Cancer Letter
of Jan. 6. Here are just a few points your readers should consider:
1. The Institut
Pasteur did file a patent application for an AIDS blood test several
months prior to Dr. Gallo and his colleagues. The problem with the
application is that it expressly stated that the test scored positive
in only 20 percent of AIDS patients. In short, the test was essentially
2. As a practical
matter, there could be no AIDS blood test until the scientific community
was convinced that a new retrovirus (now called HIV) was the cause
of AIDS. It was Dr. Gallo and his colleagues who demonstrated the
etiology of AIDS in four landmark papers published in Science
in May 1984. Similarly, there could be no blood test until HIV
isolates could be grown in significant quantity. It was Dr. Gallo's
colleague, Dr. Popovic, who accomplished this breakthrough, as described
in one of the four Science papers. Finally, there could be
no blood test unless the test scored positive in most AIDS patients.
Dr. Gallo and his colleagues described such a test in the Science
papers. The information in the Science papers provided the basis
for the Gallo blood test patent filed in April 1984.
the Centers for Disease Control nor the Institut Pasteur had any
credible results comparable to Dr. Gallo's at the time the Gallo
blood test patent was filed. In fact, in May 1984, CDC and
Pasteur scientists submitted a paper to Science (published
in July 1984) describing a test that scored positive in only 41
percent of AIDs patients. The article also stated that "it is possible"
that the French virus and the American virus were the same subtype.
Thus, at the time the Gallo patent was filed, the Institut Pasteur
did not have a comparable blood test and there was insufficient
evidence to demonstrate that the French and American viruses were
the same subtype.
4. Dr. Gallo
and his colleagues did use the French virus HIV-Lai in their blood
But this use
was accidental in two senses. First, HIV-Lai accidentally contaminated
the American isolate HTLV-IIIB just as it contaminated the isolated
LAV-Bru in the Institut Pasteur and contaminated isolates in the
laboratories of Dr. Robin Weiss and others. Second, Dr. Gallo's
laboratory could have used a different isolate, RF, for the blood
test. The draft report's suggestion that RF was not ready demonstrates
a total ignorance of the facts. RF was growing well by early 1984,
as laboratory records attest. Dr. Gallo's laboratory did not send
out HTLV-IIIB for use in the blood test until April 1984. Dr. Gallo's
laboratory clearly could have scaled up RF for use in the blood
test by April if it had chosen to do so.
5. The draft
report's claim that Dr. Gallo and his colleagues hid information
is laughable. Even before the patent application was filed, Dr.
Gallo went to Paris and arranged for the Institut Pasteur and his
laboratory to prepare joint papers concerning the French and American
viruses. These papers were prepared, but were not published at the
request of the French. In May 1984, only three weeks after the patent
application was filed, Dr. Gallo provided the Institut Pasteur with
a sample of HTLV-IIIB to work with. Dr. Gallo and his colleagues
then conducted most of the studies that led to the discovery of
the close similarity between the French and American viruses and
then to the discovery of the dual contamination. It was Dr. Gallo
and his colleagues who first reported that the AIDS virus, unlike
HTLV I and II, was heterogeneous. It was Dr. Gallo's laboratory
that reported the sequence of the HTLV-IIB isolate, thus making
comparison to the French isolates possible. It was Dr. Gallo's laboratory
that reported that HTLV-IIIB and the French isolates LAV-Bru were
different. This led to the Institut Pasteur's belated discovery
in 1991 that LAV-Bru had been contaminated by HIV-Lai in its laboratory
in 1983. Finally, once the Institut Pasteur explained about the
contamination that had occurred in its laboratory, Dr. Gallo promptly
acknowledged that his laboratory had accidentally used HIV-Lai in
its blood test. This acknowledgment was made in 1991, well before
any studies by independent laboratories or Dr. Varmus' statement
It is bad enough
that The Cancer Letter devoted so much space to such drivel.
But its use of Dr. Suzanne Hadley as a commentator is truly extraordinary.
Dr. Hadley's bias and incompetence are well known: every major scientific
misconduct report she has worked on has been thrown out. Perhaps
The Cancer Letter
will now rely
on tobacco executives to provided commentary on the causes of lung
Counsel for Dr. Robert Gallo
Crowell & Moring
Note: The Cancer Letter decided that in light of Mr. Onek's
comments about her, Dr. Hadley was owed the opportunity to respond.
Her response follows.
Hadley: OSI Underestimated Magnitude of Gallo Case
To the editor:
Mr. Onek would
do well to examine the facts in the Subcommittee staff report, rather
than trotting out yet again the same irrelevancies and unsubstantiable
claims that for years have characterized his and Dr. Gallo's responses
concerning these matters. Mr. Onek's claim that the Gallo laboratory
could have used the RF isolate for its HIV blood test is just one
example of numerous Gallo/Onek claims that are compellingly disproved
by the evidence detailed in the staff report.
As for Mr.
Onek's gratuitous, plainly silly comments concerning The Cancer
Letter's choice of commentators, they hardly warrant a response.
However, since Mr. Onek has raised the issue of competence of Office
of Scientific Integrity investigations, I gladly take the opportunity
to acknowledge that OSI missed the boat in one major scientific
misconduct case, i.e. the investigation of Dr. Gallo and his colleagues.
As the former chief investigator in the case, I can say with certainty
that no one at OSI comprehended the extent, seriousness, and systematic
quality of the falsehoods that were perpetrated in this case. Nor,
certainly, did we comprehend the significance of the official imprimatur
that years earlier had been stamped on these falsehoods. In short,
we had no idea what we were up against.
became clear in the spring of 1991, when an OSI report that pointed
out numerous false statements in the Gallo et al. patents and related
US government pleadings was dismissed by NIH/HHS attorneys with
the offhand comment that, "We don't think there's a problem here."
Shortly after preparing this report, I was forced to resign as chief
investigator in the Gallo case.
thanks to Congressman John Dingell and the subcommittee, this was
not the end of the matter. The full text of the subcommittee staff
report is now available, on the World Wide Web at the following
community and the public finally can examine the evidence and make
their own judgments about these important matters. They will find
the staff report solid in all its findings.
A LETTER FROM DINGELL TO VARMUS
Copies of the
Subcommittee Staff Report circulated widely, partly because of my
mailing, and party because others (such as Stewart-Feder) also publicized
it. I received a letter from Kenneth Ryan3
(postmarked 7 February 1995), acknowledging receipt of this Staff
Report, and stating: "I will have it reproduced for all our Commission
members. It obviously should inform our work and help in our deliberations.
I am wondering whether the new congress will be at all interested
in it. It will be interesting to see what the response of the scientific
community will be. You are to be commended for taking the time and
effort to deal with the scientific integrity issue."
pertaining to the Staff Report were sent by Stewart and Feder to
Harold Varmus, the new Director of NIH. Hearing that Varmus was
unhappy with the Staff Report, Dingell wrote to Varmus a letter
dated 3 February 1995:
I have received
a copy of a January 23, 1995 memorandum to you from Mr. Walter
Stewart and Dr. Ned Feder, as well as their letter to Dr. Kenneth
J. Ryan. They have enclosed a "draft report" that they claim was
authored by staff of the Subcommittee on Oversight and Investigations.
vouch for the authenticity or accuracy of the papers provided
Footnotes for page 597
Macy Ladd Distinguished Professor of Obstetrics, Gynecology and Reproductive
Biology, Harvard Medical School; Chairman of the Ethics Committee;
Chairman of the Commission on Research Integrity for the Office of
Research Integrity in the Public Health Service.
not reviewed, much less evaluated, by the staff director, the
Chairman, or any other Member of the Subcommittee. While some
staff time was spent developing a report, one early draft on the
matter had been rejected by the Subcommittee staff director several
months ago. Because of the election results and the resultant
time and resource constraints imposed by the transition, and the
enormity of the editing and fact-checking tasks needed to assure
that a report on this topic met the standards of the Subcommittee,
no report was issued. Drafts and relevant files on this inquiry
were turned over to the incoming majority as a pending and uncompleted
I hope that
this information will be of use to you as you and others assess
the "draft report" and respond to the requests made by Mr. Stewart
and Dr. Feder.
JOHN D. DINGELL
cc: Dr. Kenneth
recounted here (§2 and §3) were summarily and effectively
described in a Science and Government Report article: "Dingell
Ex-Staffers Release Critical Report on Gallo" (15 February 1995,
p. 5). According to this article: "SGR hears that Varmus,
not pleased with the [Dingell Staff] report, sought advice from
Harriet S. Rabb, General Counsel of the Department of Health and
Human Services, who also gets knocked in the report. Rabb took up
the matter with Dingell's staff chief, Alan J. Roth, who from way
back doubted the political value of Dingell's clashes with the scientific
establishment. The cautious solution was Dingell's letter to Varmus,
not wholly repudiating the report--which after all, was produced
under Dingell's chairman-ship--but casting doubt on its status as
an official Congressional product."
I want to conclude
here by emphasizing political, institutional, and journalistic responsibilities
involved in Dingell's letter to Varmus. Nowhere in his letter did
Dingell disavow the Staff Report itself. However, the letter lent
itself at the time to interpretations discrediting the Staff Report.
For example, Dingell wrote: "We cannot vouch for the authenticity
or accuracy of the papers provided to you." (Dingell is here referring
to the documents sent to Varmus by Stewart and Feder.) This sentence
is an abdication of responsibility, but it does not assert that
the Staff Report is deficient in any way.
the sentence sets a context for an innuendo subject to many interpretations,
namely Dingell's subsequent statement that an "early draft on the
matter had been rejected by the Subcommittee staff director several
months ago." What does this rejection mean? For what reasons? Because
the draft was 1,200 pages long (as I am told by a member of the
staff at the time)?
I remind the
reader of some official statements by Dingell in the past:
introduction to the Harmison hearings (21 July 1993), where he stated:
"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."
very critical letter to the 1992-NIH Director Bernadine Healy, dated
26 November 1992, as reported in Science and Government Report
(cf. § 1).
letter to the 1994-NIH Director Harold Varmus dated 23 February
1994, where he stated: "The contents 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
with these earlier positions, Dingell's 3 February 1995 letter to
Varmus is so ambiguously worded as to promote interpretations which
would undermine his Staff Report. I regard such a letter as a betrayal
of what he stood for over the last several years, since his Subcommittee
started investigating the Gallo case, following the Baltimore case.
the credibility of the Staff Report does not depend on Dingell or
anyone else. Indeed, the Staff Report itself does not ask to be
taken on trust. It confirms the ORI Offer of Proof and the HHS Inspector
General's Memorandum as far as they went. It gives factual documentation,
putting an entire story together,
meticulously to the record, which is verifiable. Anyone can check
out its factual assertions, as well as the direct quotes from Gallo
himself or his lawyer.
over several years in the name of truth, and in the name of scientific
and political responsibility. He was supported and encouraged by
a few scientists who went on the line despite a hostile reaction
by scientists at large. He used his staff, and persons such as Suzanne
Hadley who made heavy professional commitments. After all these
dealings, for him to have issued a letter to Varmus such as the
one he did on 3 February 1995, lending itself to interpretations
stemming from ambiguities and innuendo's contained in the letter
without his actually taking responsibility for the interpretations,
which some people are using in early 1995 to discredit everything
he claimed he stood for in the last few years, is a betrayal of
truth, of scientific and political responsibility, and of the people
who trusted him.