Gallo Case - Part 1 Part
3 Part 4 Part
Part 1 - Contents
of Gallo pp 365-367
Role of Scientists pp 367-368
THE CREWDSON ARTICLE pp 369-374
THE NAS-NOMINATED PANEL pp 375-378
THE OSI "INQUIRY" pp 379-384
INTERLUDE: SCIENTIFIC RESPONSIBILITY pp 385-393
THE OSI INVESTIGATION pp 394-408
Page numbers refer to corresponding pages in the paperback edition
of the book "Challenges"
The Gallo case
concerns the discovery of a virus called HIV in 1983-1984. The official
establishment position up to now is that this virus causes AIDS.
Since 1983-1984, there has been a controversy between Robert Gallo,
Chief of a major laboratory of the National Institutes of Health
(NIH), and scientists of the Institut Pasteur in Paris, concerning
who discovered this virus and how it was developed in a form usable
for a blood test. Following the breakdown of informal negotiations,
the French instigated a patent suit on the matter. In fact, they
launched four separate legal proceedings, including a patent "interference."
Tribune has played a major role in causing investigations of the
case, starting with a nearly book-length article (over 50,000 words)
by one of its reporters John Crewdson, on 19 November 1989. Numerous
articles by Crewdson appeared since, including an overall 'Perspective'
of the case on 6 December 1992 (nearly three full pages in the Chicago
Tribune). Crewdson was backed by strong editorial support from the
beginning. His "Perspective" of 6 December 1992 was accompanied
by three supportive editorial statements, which I recommend as exemplary
accounts of journalistic responsibility. After examining the performance
of the scientific press (or the press at large) compared to that
of the Chicago Tribune, I have concluded that the Chicago Tribune
and Crewdson achieved one of the major journalistic contributions
in decades, and that they have set standards of depth, thoroughness,
and accuracy in journalism which the scientific press might well
of the Gallo case took place in several ways
1. At first, the NIH Office of Scientific
Integrity (OSI) (created in 1989) carried its own investigation,
with Suzanne Hadley as chief investigator. Shortly after Bernadine
Healy became director of the
NIH in 1991, she forced Hadley's resignation,
and in 1992
the OSI was abolished and replaced by the Office of Research Integrity
(ORI), directly responsible to the Assistant Secretary of Health,
James Mason at the time. Thus the ORI exists within the HHS but
outside the NIH.
OSI's investigation cleared Gallo of all "misconduct,"
but found some specific problems with his conduct. The ORI's investigation
arrived at mixed
conclusions in December 1992. Gallo was partly exonerated on some
counts, but was deemed guilty of misconduct on others.
3. Gallo appealed to the HHS Appeals Board in 1993. The ORI had
also instituted proceedings against one of Gallo's laboratory coworkers,
Mikulas Popovic. The Appeals Board ruled in favor of Popovic, against
ORI. As a result of many factors, including certain conditions imposed
by this Board, and the ruling in favor of Popovic, the ORI withdrew
all charges against Gallo in November 1993. However, ORI had prepared
an "Offer of Proof" which it intended to submit to the
Appeals Board. This Offer of Proof documents many aspects of the
case against Gallo, and has lists of a number of scientists who
had offered to cooperate with ORI and to testify against Gallo.1
4. The HHS Inspector General requested a prosecution, which was
declined by the U.S. Attorney in Baltimore, MD. The U.S. Attorney
wrote back a letter to the HHS Inspector General, declining to prosecute,
for many reasons. In addition, this letter stated: "In deciding
not to seek prosecution, we recognize that this case transcends
the normal type of criminal case, and that the conduct of these
two noted scientists [Gallo and Popovic] reflects upon the integrity
of the scientific process, the National Cancer Institute, and indeed
the conduct of our government as a whole. However compelling is
the need to provide a forum for historical accuracy on these issues,
that noble desire cannot be a substitute for evidence, nor does
it justify using the criminal courts in place of the court of public
opinion." Thus the community at large was left with the alternative
of going back to the original Inspector General's Memorandum to
find out some facts (see XV and XVI).
5. Throughout this period, Representative John Dingell carried out
his own hearings and investigation. Suzanne Hadley, who was still
formally employed by HHS, was detailed to provide help and technical
advice to Dingell's Subcommittee. She remained in that position
until 15 April 1994. After that, she remained in touch
with the Subcommittee and was the principal author of the Subcommittee's
Footnotes for page 366
Offer of Proof Is available under the Freedom of Information Act,
directly from ORI (Freedom of Information Officer, ORI, Public Health
Service, Rockville, MD 20857).
of the Republican victory in November 1994, the Dingell Subcommittee
as such did not exist any more as of January 1995, and the previously
written report was made available via the staff of the Subcommittee
at that time. This Staff Report not only confirmed the findings
of the HHS Inspector General's Memorandum and of the ORI Offer of
Proof, but went beyond in documenting the case concerning Gallo
and the U.S. Government and their actions in obtaining the patent
for the HIV antibody blood test.
As an academic
and especially as a scientist, I am mostly concerned with issues
of scientific responsibility within the scientific or academic community,
including individual responsibilities and also the responsibilities
of institutions, including the universities, the National Academy
of Sciences, the government's scientific agencies, and the scientific
press. I shall document my concerns with the way some scientists
partly failed to meet their responsibilities, and partly were manipulated
by governmental agencies and officials.
The fiasco involving ORI, Popovic, and Gallo provides a significant
illustration of problems which arise in trying to maintain scientific
standards, the conflict between legal and scientific points of view,
problems which arise as a result of withholding information, partly
from attempts by some officials to cover up, partly from the incompetence
of others, partly because of the interference of "legal"
aspects, and for other multiple reasons, extensively documented
throughout the following analysis of the Gallo case.
At the beginning of the investigations by NIH and HHS, these governmental
agencies publicly took the position that the cooperation of scientists
was essential to ensure competence and credibility, and public steps
were taken to bring scientists into the picture. Throughout the
period, these scientists were manipulated, and their role was progressively
diminished until they were completely eliminated in the final stage
of certain rulings by the Appeals Board, which was constituted exclusively
the entire performance by NIH and HHS as disgraceful, but a number
of scientists also bear a heavy responsibility for not coming out
into the open on the record against the manipulations to which they
were subjected, and for not taking a clear public stand on the issues.
Scientists at large rely for information mostly on the more or less
official publications such as Science and Nature. These have done
a tendentious and highly selective job of reporting. As a result
scientists at large have been misinformed or disinformed.
Scientists in general are busy with their research. For many reasons,
including the misinformation or disinformation of the official scientific
press, they have mostly been passive in the Gallo case, with a few
notable exceptions, for example: Don Francis, John Edsall, Fred
Richards off and on, and William Hagins after the Dingell Staff
Report came out.
reacted differently at different times, so no universal characterization
applies to all of them for all times.
THE CREWDSON ARTICLE
On 19 November
1989, John Crewdson published a monumental 50,000 word article in
the Chicago Tribune: "The
Great AIDS Quest", subtitled: "Science under the microscope."
This article raised questions about Gallo's role and the role of
his laboratory in the discovery of a virus called the "AIDS
virus." (The virus is called by this name because it was accepted
almost universally after 1984 that this virus causes AIDS.) Several
viruses bearing different names actually come into play. Some, called
LAV, came from the Institut Pasteur in Paris. Others allegedly came
from Gallo's Laboratory of Tumor Cell Biology (LTCB), depending
on the National Institutes of Health. These other viruses bear other
names such as HTLV-III or MOV.1
Crewdson's article gave extraordinary and extensive factual reporting,
and bore on several problematic aspects, especially two of them.
or contamination. One of the issues was whether certain viruses
used by Gallo in his blood test were originally due to the French
scientists at the Institut Pasteur, and whether Gallo had misappropriated
the French virus (or viruses).
Footnotes for page 369
article had a precursor. In 1987, Steve Connor published two articles
in the British magazine The New Scientist 12 February 1987:
a ten-page article: 'AIDS: Science stands on trial' (pp. 49-58),
and a one- page article: 'AIDS: Mystery of the missing data' (p.
19). Both pieces bore on the legal dispute between scientists of
the Institut Pasteur in Paris, and the U.S. government, and on some
of the issues later raised by Crewdson. Connor brings
up a number of very specific questionable items. For example, the
one-page article mentions a letter "sent between scientists at the
US's National Cancer Institute (NCI), in Maryland, which is at
the center of the dispute.... The copies of the letter provide powerful
evidence that someone has tampered with scientific data. One copy
shows that the NCI had photographs of the Pasteur's virus, called
IAV, in December 1983, six months before the American institute
announced the discovery of its AIDS virus, which its researchers
called HTLV-III. In the other copy of the same letter, someone has
erased this information.' The ten-page article deals
with some details, pointing to the possibility that HTLV-III was
the same as the French virus LAV. Subsequently, this was shown to
be the case by a genetic sequencing analysis.
was raised whether the French virus had contaminated his own accidentally,
or whatever other possibilities could arise. Crewdson went into
considerable detail documenting some reasons why a certain virus
claimed by Gallo to have been independently isolated in his laboratory,
and used in his blood test, was actually the same as the French
It is extremely difficult to summarize the Crewdson article, because
of its comprehensiveness and technicality. Many people have had
this difficulty. For instance, in the Washington Business Journal
(6 August 1990) Philip Boffey, science editor for the New York
Times is quoted as saying: "As far as Crewdson's takeout
goes, I thought it was an outstanding job, but it was hard to know
what to do with it. It isn't an easily summarized piece. We just
decided we couldn't duplicate his work."
which came out subsequently confirmed Crewdson's documentation.
(a) DNA sequencing analyses confirmed unambiguously that the virus
used by Gallo for the blood test came from the French Institut Pasteur.
(b) The question of "contamination" was also settled.
It turned out that there was not a single sample of French viruses
sent to Gallo in September 1983 but two, called LAV-Lai and LAV-Bru,
taken from two different patients in France. Both were sent to Gallo
by the Institut Pasteur. Thus there was contamination in the French
laboratory between their virus samples. However, this contamination
in France did not affect the fact that Gallo used the French virus(es)
LAV, whether it's Lai or Bru. These events were properly reported
subsequently in the HHS Inspector General's Memorandum dated 10
June 1994 (p. 16, item 3, discussed in detail below in XV,
§4), and were further confirmed in the Dingell Subcommittee
(c) Gallo himself in a letter to me brought out several specific
points of contention. In my reply (see LXI, I documented how he
made false statements and improperly represented events. For instance,
throughout 1985 and 1986, Gallo made repeated public statements
quoted in the press, that "no one has been able to work with
[the French] particles," that "the amount of virus Montagnier
sent would not have been sufficient to infect a cell line,"
and that to suggest his viruses and the French virus were the same
was "the height of outrage," because "it was physically impossible
to grow the particular virus sent by Montagnier." Readers will
find the precise documentation in our exchange of letters
footnotes 3, 4, and 5 of my reply, showing Gallo's statements to
be false or misrepresentations. For instance, as I also bring up
in my reply, successive drafts of the paper in which Gallo and coauthors
announced their discovery of the so-called AIDS virus show that
Gallo deleted sentences by Popovic acknowledging indebtedness to
the Institut Pasteur. These deletions were later mentioned in the
ORI Offer of Proof (see XII, Appendix 3, especially pp. 86 and 87),
as well as in the HHS Inspector General's Memorandum of 10 June
1994 (see the item referring to 30 March 1984 in the chronology
of events), and the Dingell Staff Report.
patent application for the blood test. Another issue was the
legitimacy of Gallo's patent applications for his blood test. Some
of the points Crewdson covered in his original article of 19 November
1989 were repeated in his subsequent article 'Inquiry hid facts
on AIDS research" (Chicago Tribune, 18 March 1990, p. 17),
where Crewdson wrote: A secret
government inquiry four years ago into the AIDS research of Dr.
Robert C. Gallo uncovered evidence that he was not the discoverer
of the first AIDS virus and that the virus from which he later developed
a patented blood test for AIDS was probably the same one isolated
nearly a year before at the Pasteur Institute in Paris.
briefs later filed by the government in the U.S. Court of Claims
and before the Patent and Trademark Office nonetheless concluded
that Gallo was the first to identify the cause of AIDS and develop
the AIDS test, and that the culture from which the test was made
could not have been contaminated by a sample of the French AIDS
virus sent to him by Pasteur researchers.
also reflect many of the misstatements and omissions about the AIDS
research conducted by Gallo and the Pasteur scientists contained
in a confidential 1985 report prepared by a senior official of the
National Cancer Institute for use in defending the government against
impending legal actions by the French.
to a copy of the report and related documents obtained by the Tribune,
these are among the numerous legal claims unsupported by Gallo's
laboratory records and other documents produced by the internal
- That genetic
evidence "conclusively" established that the Gallo AIDS virus
was an independent isolate and not the same virus the French had
earlier sent Gallo for testing.
- That Gallo
actually discovered the AIDS virus a month before the Pasteur researchers
but withheld news of his discovery for more than a year.
- That Gallo's
lab was the first to develop a blood test that could accurately
measure exposure to the AIDS virus and thus the lucrative patent
on that test rightfully belonged to the U.S. government, not the
Haddow, then chief of staff to Health and Human Services Secretary
Margaret Heckler, said in a recent interview it was possible that
the Justice Department lawyers had been denied the full facts about
like I'd been misled," Haddow said, "and there may have been
people in the Justice Department who received information where
they were misled. I couldn't sort it out and I don't think very
many people could.... There was a point where it became very clear
to me that the NIH people were not being truthful," Haddow recalled.
'These people would sit down for one meeting and then in a subsequent
meeting the stories were different.... They weren't even smart enough
to get their stories straight before they talked to me," he said.
"how in the world could they get through a court proceeding?"
Footnotes for page 372
also surfaced later with comments putting into question the U.S.
Government's case in the patent application. Dan Greenberg's Science
and Government Report of I July 1992 has this to say:
HHS's nervousness about the Gallo
case has been compounded by damaging statements by a former HHS
office who was there when Gallo reaped glory as the discoverer of
the AIDS virus, C. McClain Haddow, HHS Chief of Staff from 1983-87.
Haddow's credibility is sullied by the fact that, in a matter unrelated
to the Gallo case, he was convicted of violating federal conflict
of interest regulations and imprisoned for four months. But his
account of the Gallo affair has received a good deal of attention
lately, with reports in the New York Times of June 25 [19921
and in a BBC production on the case, 'Taking the Credit."
The Times report states that "Mr.
Haddow now says that from the beginning some top HHS officials had
doubts about Dr. Gallo's account [of the discovery of the AIDS virus."
In the BBC production, Haddow states,
"Well, the determination we finally came to after investigating
it was that Bob Gallo, as strong as he was on his views, couldn't
support the claims he was making from a legal standpoint.... The
French attorneys ... didn't know how weak our case was and they
never discovered it. So we were able to craft an agreement that
probably disadvantaged the French, but it was because we hid our
weakness fairly effectively. We felt in a political sense that it
was important for President Reagan to show that he had an interest
in the AIDS problem...."
In his articles,
Crewdson also reported the existence of a 1985 report by Dr. Peter
J. Fischinger, then the Cancer Institute's associate director. According
to the article of the 18 March 1990:
report includes a signed statement from Gallo attesting to the accuracy
of the information it contains.
sued the U.S. government in December 1985, its attorneys requested
copies of all documents relating to Gallo's isolation of the AIDS
virus under the Freedom of Information Act. Although more that 5,400
pages of records were ultimately produced, about 20 documents were
withheld on the grounds that they were "deliberative" or "predecisional."
withheld were three documents related in the Fischinger report,
all marked "administrative confidential," written in August and
September of 1985 as the government began laying the groundwork
for its eventual defense against the French.
documents are a memo from Fischinger summarizing his findings to
Lowell T. Harmison, then a senior official of HHS; a memo from Fischinger
to Gallo expressing the concerns of other government scientists
about Gallo's work, and Gallo's reply to that memo.
article went on to relate in detail certain internal contradictions
in all the memos going back and forth in 1985.
further developments. Subsequent investigations by OSI or its
successor ORI (Office of Research Integrity) did not clear up all
these contradictions. OSI referred questions having to do with the
patent application to the HHS Office of the Inspector General, because,
according to Suzanne Hadley, OSI was advised by the office that
such questions might require a criminal investigation. As we shall
see later, the Inspector General completed an investigation and
asked the U.S. Attorney in Baltimore, MD, to start a prosecution,
but the U.S. Attorney declined, leaving the responsibility directly
on the scientific community (see XV and XVI)
the HHS Inspector General's Memorandum of 10 June 1994 reported
(p. 27, see XV. §4 below):
Office] examiner advised the OIG [Office of the Inspector General]
that, had she been aware of the IP [Institut Pasteur] prior art
at the time she examined the blood test application of Gallo, she
would have suspended prosecution of the Gallo application and declared
an interference between the two applicants. An interference was
eventually declared, but not until two years after the initial Gallo
submission. The IP scientists were eventually named Senior Party
in the interference, confirming their priority in submitting a patent
application on the HIV antibody blood test. By the time the interference
was declared, the Gallo patent had long since been issued."
were confirmed in the Dingell Subcommittee Staff Report (see XVIII).
from the Crewdson articles in the Chicago Tribune, NIH decided to
look into the matter of Gallo's role in the discovery of the so-called
"AIDS virus." To enhance the credibility of their Gallo investigation
they thought of covering themselves with the prestige of a panel
to be nominated by the National Academy of Sciences. In a letter
dated 15 February 1990, James Mason, Assistant Secretary for Health
and Acting Surgeon General, solicited NAS President Frank Press
to nominate such a panel, "with a view to ensuring both the fact
and appearance of objectivity for the inquiry." Mason was writing
at the request of William Raub, Acting Director of NIH, and endorsed
the request. Mason specified that "the panel would counsel
NIH's Office of Scientific Integrity regarding the focus of the
inquiry and the analysis of the findings. If a subsequent investigation
proves necessary, the panel would be asked to continue its advisory
role through that phase as well."
replied on 22 February 1990 that a list of nominees would be provided
within a few days, and also emphasized: "We note that you will draw
the advisory panel exclusively from this list...." In addition,
Frank Press cautioned: "Also, in view of the fact that the NAS and
IOM [Institute of Medicine] are serving no role other than nominating
individuals, with no further involvement or responsibilities involving
our own institutional processes, it would be inappropriate to call
this an NAS/IOM Committee, or to attribute any resulting report
to the Academy. However, you may if you wish note that the committee
was nominated by the Presidents of the NAS and IOM after consultation
with a group of members of our institutions knowledgeable about
the pertinent sciences."
of this panel received considerable publicity in the scientific
press and elsewhere. I reproduce in a box some of the news items
reporting its creation.
NIH director James B. Wyngaarden, now a deputy director
of the White House Science Office, is among those who urged
NIH officials to turn to outside observers in the hope that
their oversight will preclude accusations that NIH is not
entirely objective in its review....
Director William Raub, along with Joseph E. Rail, director
of intramural science, have asked Frank Press, president
of the National Academy of Sciences, and Samuel 0. Thier,
president of the NAS's Institute of Medicine, to nominate
a slate of qualified observers to verify the independence
and thoroughness of the NIH's own investigation. According
to the current scenario, a jury of peers would then be selected
from the NAS-IOM panel by James 0. Mason, the assistant
secretary for health. "We decided to go the 'extra mile'
for the NIH's sake and for Dr. Gallo's," Raub told Science.
and Thier have agreed to propose such a panel with the stipulation
that Mason confine his selection to that list and agree
not to add anyone recommended by the government, which can
be said to have a stake in the outcome because it is a signatory
to the U.S.-French agreement...
be asking their advice on both the strategy of our review
and the substance of the conclusions. We'll need some running
room to do a thorough job." NIH Goes the 'Extra Mile' on
Gallo" by Barbara Culliton, Science, 23 February
trying to get the best outside people we can-the most serious,
important people, who have no vested interest," said Dr.
Joseph E. Rail the deputy NIH director for intramural research,
who is in overall charge of the investigation. "We're determined
to have the process above reproach."U.S. agency probing
AIDS virus discovery" by John Crewdson, Chicago Tribune,
25 February 1990
University biochemist Frederic M. Richards, who is described
by colleagues as a man of exceptional integrity, has agreed
to chair the committee. (Science, 30 March 1990.)
say committee members have promised not to discuss their
deliberations until they are complete. At that point, they
expect to "speak out loud and clear." "Inside the Gallo
probe-The Committees" by Barbara Culliton, Science, 22
panel was chaired by Fred Richards, Professor of Molecular Biophysics
and Biochemistry at Yale. The other members of the panel at the
Dean of the Georgetown University School of Law.
Stanley Falkow, Professor of Microbiology at Stanford University.
Alfred Gilman, Professor and Chairman of Pharmacology at the University
of Texas Health Science Center.
Harry Gray, Professor of Chemistry and Director, Beckman Institute
Arnold J. Levine, Professor of Molecular Biology at Princeton University.
H. E. Morgan, Senior Vice President for Research at the Geisinger
Mary Jane Osborn, Professor of Microbiology at University of Connecticut
John D. Stobo, Professor and Chairman of Medicine at Johns Hopkins.
Joseph Sambrook, Professor and Chairman of Biochemistry at the University
of Texas Southwestern Medical Center.
Robert Wagner, Professor of Oncology and Microbiology at the University
Stanley Falkow and Harry Gray dropped out.]
charge to the panel was as follows:
I. To counsel
the NIH on the focus and process of the inquiry, particularly the
issues being examined.
II. To review
the findings of the inquiry and recommend if a formal investigation
of possible scientific misconduct is warranted-or-if the matter
should be closed.
(If a formal
investigation is initiated, members of the consultant panel will
be asked to assist in the investigation.)
A formal investigation would be called for if there is substantial
reason to believe scientific misconduct may have occurred.
misconduct' is defined as "fabrication, falsification, plagiarism,
or other practices that seriously deviate from those that are commonly
accepted within the scientific
for proposing, conducting, or reporting research. It does not include
honest error or honest differences in interpretations of judgments
of data." (42 CFR Part 50.)
This NIH 'inquiry'
was done by an "'Inquiry Team' which was part of the NIH Office
of Scientific Integrity, referred to as OSI. As mentioned above,
this 'inquiry' was to determine whether a formal Investigation was
On 29 June
1990, Howard Morgan and Fred Richards wrote for their panel to William
Raub, to recommend a formal investigation: "The panel met on June
7.... The Inquiry Team consisting of J. Hallum, S. Hadley, and P.
Parkman presented a portion of their findings centered on the work
of the laboratory in the period from April 1983 to August 1984....
The panel voted unanimously to recommend the following action to
you: termination of the inquiry phase of proceedings and institution
of the formal investigation. This decision was based on the review
of material presented at the meeting. Some data appeared to be missing
from the data books. There is a possibility of selection and/or
misrepresentation of data. There is a need for the panel to plan
experiments on the viral samples that have been sequestered or that
can be located....'
replied negatively on 23 July 1990, that it would be 'premature"
to go into a formal investigation. However, under pressure from
the Richards Panel, such an investigation by OSI did start, and
Suzanne Hadley headed this investigation.
of the investigation was made by the NIH Acting Director William
Raub in a press release 5 October 1990. This press release was phrased
in an ambiguous way. I reproduce it in full in a box.
by Dr. William F. Raub
National Institutes of Health
October 5, 1990
Into HIV Research Conducted by Dr. Robert Gallo et al.
NIH Office of Scientific Integrity has reported to me on the
progress of its inquiry into research on human immunodeficiency
virus conducted in the Laboratory of Tumor Cell Biology of
the National Cancer Institute under the direction of Dr. Robert
inquiry has resolved certain of the publicized allegations
and issues or shown them to be without substance. In particular,
the inquiry team has concluded that Dr. Gallo had a substantial
number of HIV detections and isolations from several different
sources at the critical time that HTLV-IIIB (the principal
virus isolated by the Gallo laboratory) and LAV (the virus
isolated by the Pasteur Institute) were being grown in Gallo's
have determined, however, that certain issues identified during
the inquiry phase warrant a formal investigation. The investigation
will focus on several aspects of published reports from Dr.
Gallo's laboratory, particularly the report published by Popovic
et al., Science, May 1984. Subjects of the investigation
are Dr. Gallo and Dr. Mikulas Popovic. The investigation will
also include testing of a number of biological samples in
an effort to determine the origins of HTLV-IIIB, the virus
that Dr. Gallo and his colleagues used to develop the blood
test for human immunodeficiency virus (HIV).
investigation will be conducted by the Office of Scientific
Integrity, with the assistance of a panel of expert scientific
advisors drawn from the extramural research community. The
consultants nominated by the National Academy of Sciences
and the Institute of Medicine will continue to provide oversight
and guidance as they did during the inquiry.
We are here
concerned with the two middle paragraphs, concerning doings in Gallo's
laboratory, rather than the administrative aspects of the inquiry
or investigation. The ambiguity of Raub's press release gave rise
to conflicting reports in the press.
1 Compare, for instance, the headline in
the Washington Post, "NIH Bolsters Claim of AIDS Pioneer-Gallo
" but cleared,' with the New York Times headline: 'U.S. Inquiry
on Misconduct in Discovery of AIDS Virus." The Science article correctly
noted: 'And that left people baffled. What was NIH trying to say'.?'
The Chicago Tribune also noted in a "Media watch' headline by James
Warren: 'AIDS controversy-Conflicting reports leave readers in a
In Raub's statement
that "the inquiry has resolved certain of the public allegations
or shown them to be without substance," there is an innuendo that
Crewdson may have falsely made certain allegations because Crewdson's
articles in the Chicago Tribune since November 1989 had been the
principal cause for the renewed consideration given to the Gallo
case. Crewdson tried to get a more precise explanation of what Raub
meant in his press conference, and he checked with Raub directly.
Raub then disclaimed having Crewdson in mind. I shall quote from
Crewdson's article in an appendix to this section so readers have
a more informed basis to evaluate Raub's statement. As a matter
of journalistic and scientific responsibility, it was incumbent
on Raub in his press release to make precise who made what "allegations'
and when, as well as to give evidence why these allegations were
deemed to be "without substance.' Raub's failure to do so had elements
of scientific and journalistic irresponsibility. His statement cannot
even be called 'false," because his statement had no
Footnotes for page 381
reports on these events include
'U.S. Inquiry on Misconduct In Discovery of AIDS Virus,' and
'U.S. Agency in Reversal, to Look Into Discovery of the AIDS Virus,'
New York Times, 6 October 1990, p. 1.
'Agency orders probe of AIDS researcher,' Chicago Tribune, 6 October
1990, p. 1;
the same article also appeared on 7 October,
"NIH Bolsters Claim of AIDS Pioneer," Washington Post, 6 October
'AIDS probe shifts to next gear,' Chicago Tribune,
7 October 1990, p.19.
'Gallo Inquiry Takes Puzzling New Turn,' Science, 12 October 1990,
'Heroes Against AIDS, Sung and Unsung," editorial in the New
York Times, 14 October 1990.
'AIDS controversy-Conflicting reports leave readers in a muddle,'
Media Watch, Chicago Tribune, 31 October 1990.
However, the ambiguity of his statement impaired the public understanding
of what was going on, it impaired the possibility of evaluating
the conclusions of the Richards Panel, and it set the stage for
divergent interpretations in the press, as in the conflicting headlines
of the Washington Post and the New York Times.
A similar criticism
can be made of the other paragraph, that 'the inquiry team has concluded
that Dr. Gallo had a substantial number of HIV detections and isolations
from several different sources at the critical time...." What did
this conclusion mean or imply'? What were the detections and isolations?
What were they good for? When? Involved here are also technical
aspects of biology. In speaking of "isolations" or 'detections,'
what is meant? To what extent does "isolation" differ from 'detection'?
A number of concepts arise, among which are:
- the separation
of the virus from all other viruses,
- the use of a reagent specific to that particular virus;
- the continuous growth of the virus in fresh cells (called primary
- the continuous growth of the virus in a cell line, i.e. cells
which duplicate themselves
On the basis
of Raub's statement, one could not know precisely what the inquiry
team concluded. Gallo had blood samples from patients all over the
world, and the following questions arose:
observing transient growth of an uncharacterized virus, what was
Gallo's laboratory doing and when? What is the critical time" referred
to by Raub? One possibility was that Gallo's laboratory was able
to grow an HIV virus in a cell line at a certain 'critical time"
only by using the virus stemming from the Pasteur Institute. Did
Raub mean by 'critical time" the time needed to have priority in
making the patent application? How would such a timing affect the
patent application and royalties from the patent? In an appendix
to this section, I shall reproduce Crewdson's account of the way
Raub was issuing misleading statements. We shall also return to
these questions in Section V, where we consider the way the OSI
and ORI investigations dealt with them.
gave a list of items which were to be investigated. As stated by
Crewdson in his October 6-7 article in the Chicago Tribune: 'Not
included in Raub's list, however, are several apparent conflicts
between Gallo's laboratory records and sworn statements he later
made in defending his AIDS test
a legal challenge by Pasteur.' In connection with the patent application,
the New York Times commented: -The continued investigation
casts a shadow over those patent agreements. It is not clear what
would happen if the panel found that IIIB was in fact derived from
Dr. Montagnier's virus, because the patent used that strain but
focused on the method developed by Dr. Popovic to grow the virus
continuously in culture.' Ultimately, It was determined by a genetic
sequencing analysis that HTLV-IIIB is indeed the same as the French
virus LAV (so is MOV). However, as of 1993, it was still not clear
what will happen to the patent suit.
public statements by NIH officials. A year after Raub's press
conference of 5 October 1990, a public statement by NIH on 18 October
1991 went beyond by making explicit what had previously been left
as an innuendo: '... the OSI has determined and announced previously
that since Dr. Gallo had several HIV isolates in his laboratory
as well as a continuous culture of a virus not related to the French
virus, he had no need to appropriate the virus from the Pasteur
statement is misleading on at least two counts, and is false if
one makes more precise certain time periods alluded to in the statement.
- Gallo did
not have a continuous culture of a virus not related to the French
virus in the period October 1983-January 1984.
- The phrase
'he had no need to appropriate the virus from the Pasteur Institute'
was not announced previously. In Raub's 5 October 1990 statement,
it was left as an innuendo.
"Health official reaffirms issues in AIDS lab probe"
Chicago Tribune, 28 October 1990, p. I
to Raub, the decision to investigate the possibility that Gallo
had no other 'detections and isolations" of the AIDS virus was based
not on the Tribune article, which made no such assertion, but on
things "that others in the rumor mill of the scientific community
... But Raub
told the Tribune that he and the NIH investigative panel "didn't
rule out misappropriation," and he cautioned that his statement
not be "over read."
All the group
was trying to say," Raub said, 'was that it found what it viewed
as adequate evidence supporting what is reported" in the second
of a series of four landmark papers Gallo published in a single
issue of the journal Science in May 1984.
The paper in
question reports detections and isolations of the AIDS virus in
cells taken from 48 patients, but says nothing about how many of
each were made or when they were obtained.
detections and there were isolations," Raub said. "The paper is
more careful about that than some of the news reports. To the extent
that there are people appropriately concerned about whether there
was a deliberate misappropriation, one can't rule out misappropriation.
But one can at least say that the obvious motive where nothing else
was working, or where nothing was available even, was dealt with."
however, that saying Gallo had made his own 'detections and isolations"
of the AIDS virus was "quite different' from saying that such viruses
were growing continuously in his laboratory and thus represented
an alternative source of virus to the French LAV or his own HTLV-3B
with which Gallo could have performed the principal experiments
he reported in Science.
In the first
of the four Science articles, which investigators have dubbed 'Paper
A,' Gallo claimed he had grown one of his own AIDS viruses continuously
for at least five months before the paper was submitted for publication.
But the NIH investigators determined, according to Raub's letter
to Gallo, that the culture in question apparently had been 'repeatedly
fed with virus and thus cannot be accurately characterized as 'continuous.';
INTERLUDE: SCIENTIFIC RESPONSIBILITY
In trying to
evaluate the performance of scientists, as individuals or as members
of a group, I hope that one standard (among several) would be accepted,
namely to ascertain first precisely what responsibility is taken
on by the individual or group, toward whom. I shall deal here with
a concrete instance of ambiguous responsibilities incurred by some
scientists in connection with the Gallo case.
Raub, Acting Director of NIH, took responsibility for his press
release of 5 October 1990 (speaking for NIH), but he also stated:
"The consultants nominated by the National Academy of Sciences and
the Institute of Medicine will continue to provide oversight and
guidance as they did during the enquiry.' Thus Raub was invoking
the prestige and credibility of other institutions (NAS and IOM)
in connection with the NIH 'inquiry" or "investigation' of Gallo.
As a result, I thought it was important to clarify the role of these
people nominated by the NAS and IOM. In order to elicit information,
I wrote several letters: to Raub, to James Mason at HHS, to Frank
Press, and to Fred Richards, Chairman of whatever-it-is. None of
the answers I received described precisely what was the responsibility
of those people.
In a letter
dated 13 November 1990, Fred Richards wrote me: "Last spring nine
individuals ... were asked to serve as consultants to the National
Institutes of Health....' A first ambiguity was: "asked" by whom?
Frank Press and the NAS-IOM? HHS? NIH?
was whether the 'consultants" were individuals who would have only
individual responsibility, or whether they constituted 'the Richards
Panel,' speaking with a common voice and common responsibility (to
whom: NIH? HHS? the scientific community? NAS? IOM?). Various names
have been used for
Whatever-it-is, among which are:
Committee' (by Frank Press, in a heading above his list of 11 names);
"advisory panel" (by Frank Press, in a letter to Raub dated 22 February
'the Committee on which I serve' (by Fred Richards, in a letter
to a British scientist Abraham Karpas dated 28 June 1990);
"consultants nominated by the National Academy of Sciences and the
Institute of Medicine" (by William Raub, in the press release of
5 October 1990);
'consultants to the National Institutes of Health" (by Fred Richards,
in a letter to Lang dated 29 October 1990); and
'nine individuals ... consultants to the National Institutes of
Health" (by Fred Richards, in a letter to Lang dated 13 November
of names has had the effect of confusing the community, misleading
the community, and rendering ambiguous the responsibilities of those
on Whatever-it-is, whether as individuals or collectively as a "panel"
Talking to the Press
In his letter
to me of 13 November 1990, Fred Richards did not answer any of my
questions, and he wrote me: 'At our first meeting we agreed unanimously
that all communications with the press or with interested individuals
concerning the inquiry or investigation would be handled by the
appropriate office of the National Institutes of Health. I intend
to stand by that agreement.'
I am not concerned
with intent, but I want the community to compare Fred Richards'
statement with some facts:
the Science and Government Report (SGR) of 15 October 1990,
Dan Greenberg first mentioned the 'literary opacity' of Raub's press
release, followed by the resulting conflicting reports in the New
York Times and Washington Post, and then he wrote:
of enlightenment, SGR sought the counsel of Frederic M. Richards,
Professor of Molecular Physics and Biochemistry at Yale University
... Richards told SGR that his panel had been consulted in the preparation
of Raub's announcement and that it approved of its content. But
which newspaper was correct? Replied Richards: 'If you take the
average of the Post and Times, you'd probably get it right.'
Science (12 October), Barbara Culliton wrote: "Science has learned
[from whom?] that the decision to conduct a formal 'investigation'
was pushed on Raub by the Richards Panel. The consultants have maintained
from the start that calling the months-long NIH examination an inquiry
was a semantic fiction, but Raub resisted an earlier request to
designate it an 'investigation ...... She went on:
Panel member, speaking on a promise of anonymity, said: 'There was
never any positive evidence of theft. And now, having seen his [Gallo's]
records, we know there was no motive. There was no conceivable reason
to steal anything.'...
Culliton also mentioned a list of 28 specific questions put to Gallo
by the NIH Office of Scientific Integrity. She quoted Gall about
his 'answers.' Then she wrote:
panel members whether it would be fair to conclude that Gallo's
answers to questions about the Science paper were not satisfactory.
'Answers? What answers?" asked one panelist. As Science goes to
press, it remains unclear just what the panel was told.
a 28 October 1990 Chicago Tribune article, James Warren wrote:
members of the scientific panel that handled the just-ended 10-months
inquiry, Culliton discovered, . 'some believe what's left [to be
investigated] to be serious, others don't.'
Richards and other members of Whatever-it-is were communicating
with the press, agreement or no agreement, 'intent' or no "intent.'
In addition, my letter to Fred Richards of 8 November 1990 started
with a reminder of his communication with Dan Greenberg' SGR as
per item (a). Consequently I regard Fred Richards' reply
of 13 November 1990 as Kafkaesque. In light of the history
of our relationship, his reply caused me a profound disillusionment.
Evasion of Substantial Issues
"agreement' (which was de facto inoperative at times of people's
own choosing) had one effect (among others), to perpetuate the fudging
of responsibilities, to withhold information, and to cause only
a certain type of information (or disinformation) to make it into
the press, while concrete factual questions were stonewalled. In
particular, I did not get answers to substantial and specific questions
raised in my letters to Fred Richards dated 31 October and 8 November
1990, and my letters to James Mason and William Raub of 31 October
1990. In these letters, I raised three types of questions.
- one type
having to do with the meaning of "oversight' and the extent to which
Whatever-it-is took responsibility for Raub's statement, whether
it took responsibility to leave certain specific items out of the
- another type
having to do with the merits of the Gallo case: What did he have
- a third type having to do with public statements by the higher-ups.
I object to the ambiguities of the "panel"-approved Raub statement
of 5 October 1990, referring to "certain allegations' which were
'resolved,' without specifying which allegations, who made them,
their scientific significance, or how they were resolved. Indeed,
Crewdson has been extraordinarily careful in his articles, and he
never used the words "theft or "steal." However, in the context
of Crewdson's articles, there was an innuendo in Raub's statement
that Crewdson himself made certain allegations, while Raub and his
"consultants' managed to evade facing publicly the specific issues
raised by Crewdson. I object to the impossibility which I have encountered
to have these ambiguities cleared up.
One of the
great merits of Crewdson's articles has been their documented, factual,
informative content: extensive, specific, and correct. He was factual
in his reporting and factual in the way he phrased his analyses
and his questions. He deserved to be answered in kind, but I ask
the community to compare Crewdson's concrete factual journalism:
- with Raub's
'panel'-approved ambiguous statement which gave rise to conflicting
and confused reports in the press;
- with the
tendentious and anonymous statements by 'panel members' who make
statements to the press having journalistic force without taking
responsibility for them or being accountable for them, especially
the statement about 'motive" and 'theft" and
- with Fred
Richards' sentence quoted by Dan Greenberg: 'If you take the average
of the Post and Times, you'd probably get it right." What does this
sentence mean? What is its function and effect in the press? As
far as I am concerned, this sentence perpetuated loose statements
in the press, aside from contradicting 'Fred Richards' statement
of intent to abide by the agreement, namely not to communicate with
the press except through the 'appropriate office' of the NIH.
I object to
a 'panel member' giving to the press a statement about a 'motive'
using the words 'to steal" and 'theft," engaging the responsibility
of the whole 'panel' ("we know...'). By issuing such a statement
to the press based on such loaded words the anonymous panel member
was in contravention of the standards of science which I have taken
for granted since I was an undergraduate at Caltech, and which Crewdson
himself has followed. A paradoxical situation thus has arisen when
a journalist meets certain scientific standards, while some scientists
do not. Under the circumstances I ask the community to evaluate
the credibility, competence, and standards of Whatever-it-is.
Accountability and Responsibility
I have tried
to uphold certain standards: check out facts, check out the press
reports, ask for more details and specific information, and address
those concerned directly. I have met with evasions and stonewalling.
Does the scientific community have objections to my raising questions
as I did? Will it tolerate such defective responses?
I object to
the ambiguous position of responsibility and accountability in which
the scientists on Whatever-it-is accepted to place themselves. What
are "consultants"? When a business firm hires 'consultants,' then
the responsibility of the consultants is toward the firm, and they
are paid for a certain type of professional or technical advice.
They represent the interests of the firm. They are accountable to
the firm. Were the members of Whatever-it-is such consultants, accountable
only to NIH or HHS?
There is evidence
of something else. Frank Press himself emphasized the role which
the reputation of the NAS was playing when he accepted to nominate
them and when he authorized HHS and NIH to refer to this NAS-IOM
nomination. He also engaged the reputation of the NAS-IOM when he
wrote 'NAS' in front of five names out of eleven on his list of
the 'NIH Investigative Committee' and "IOM' in front of two names.
Raub's press release of 5 October 1990 did make public reference
to the NAS-IOM nomination. Raub used the reputation of the 'consultants'
and their NAS-IOM pedigree to give public credibility to the NIH
investigation when he mentioned their role to 'provide oversight
and guidance.' However, Barbara Culliton's report that some panel
members (communicating anonymously with the press) are not even
aware of "answers" by Gallo to a list of 28 questions by the Office
of Scientific Integrity (see Item §2(c)) raised questions
about the trust we could have in the panel's ability to provide
'oversight and guidance.'
I gave up some
time ago on the standards of the higher-ups at NIH, but I had hoped
that the scientists on Whatever-it-is at least would be responsible
to the community at large, and would meet other standards. We have
had a model of higher standards and accountability before. When
Feynman was asked to be a member of the Commission investigating
the Challenger disaster, he gave us such a model of scientific responsibility.
He first got information without problems from the Jet Propulsion
Lab at Caltech. He resisted some attempts by William P. Rogers to
inhibit his investigation. He interviewed engineers and higher-ups
at Morton Thiokol. He was especially interested to explain scientific
facts to the public, when he went to the hardware store to get screwdrivers,
pliers, and a small C-clamp to do an experiment in front of the
video cameras, at a public meeting of the Commission, showing how
rubber O-rings lose their elasticity at low temperatures. He wrote
a special report, which Al Keel (Executive Officer of the Commission)
promised to show everybody, but it turned out at first that neither
staff members nor commissioners saw the report. Then, as Feynman
writes, "I kept pushing on it, watching it, nursing it along, and
finally got it through to the point where it was, at last, in the
hands of a real editor, a capable man by the name of Hansen, who
changed all my whiches to thats and thats to whiches. Mr. Hansen
fixed up my report without changing the sense of it. Then Mr. Keel
fixed it up so it could go in as an appendix... .' And ultimately
Feynman wrote up his experiences on the Commission in his article
"An Outsiders View of the Challenger Inquiry' (Physics Today, February
1988), and in his book
'What do you
care what other people think?." I quote from the article:
One of the
ways I was unique was that I was not connected to any organization--I
had no weakness from that point of view. I was, of course, connected
with Caltech, but that's not a weakness! For example, General Kutyma
was in the Air Force, so he couldn't say everything exactly the
way he wanted, because he might get in trouble with the Air Force.
Sally Ride had a job at NASA. Everyone on the commission had some
kind of connection and therefore some kind of weakness, but I was
apparently invincible ....
accepted being connected with NIH, when he invoked the 'agreement'
(which he did not always follow). What else is he connected with?
He's connected with Yale. Is that a "weakness'? The other 10 members
of Whatever-it-is on the list sent to me by Frank Press are connected
with Caltech (Harry Gray), U. of Texas (Alfred Gilman), U. Conn
(Mary Jane Osborn), Stanford (Stanley Falkow), U. of Texas (Joseph
Sambrook), U. of Virginia (Robert Wagner), Princeton (Arnold Levine),
Johns Hopkins (John Stobo), Getsinger Clinic (Howard Morgan), and
Georgetown University (Judith Areen). Are the connections with these
with the press and the media Feynman wrote:
I did, however,
keep talking to the press--openly, always giving my name. I didn't
want any hocus-pocus about 'unidentified sources," or anything....
NBC interviewed me--they caught me in the lobby of my hotel. They
interviewed me for 15 to 20 minutes--the lady reporter was very
short and very nice-- and I talked in my usual, careful professional
way, with all the caveats and so forths and so ons. I saw the interview
later on the "Nightly News': I was on for about two seconds--I say
something, and BOOM!-it's over. But it was good: The report carried
the line of what I said, and the reporter put the context around
it, saying things like, 'The professor went on to say that this
was only the result of a mathematical model and might be uncertain"-stuff
like that. It was excellent....
There is also
the passage where Feynman relates how he objected to
some recommendation in the Commission Report.
Rogers first told him that he was "outvoted' by the other commissioners.
Feynman says "How was I outvoted when there was no meeting?," and
Feynman writes about Rogers' reply: "I know, but I called each one
of them up," he said, 'and they've all agreed. They've all voted
for it." But then it turns out that a number of commissioners had
not even been contacted by Rogers, and that Feynman was being "railroaded
into modifying his report, even though it was going to appear only
as an appendix." So he sends a telegram to Rogers:
MY SIGNATURE OFF THE FRONT PAGE OF THE REPORT UNLESS TWO THINGS
OCCUR: 1) THERE IS NO TENTH RECOMMENDATION, AND 2) MY REPORT APPEARS
AS AN APPENDIX WITHOUT MODIFICATION FROM VERSION #23 OF MR. HANSEN.
here who is taking responsibility for what.
of behavior is far from the model given to us by William Raub-NIH
and Fred Richards-Whatever-it-is. Over the last few years, I haven't
found many instances of the Feynman model in handling the politics
or policing of science, but I have found plenty of instances of
another model: evasion, fudging, and obstruction of information,
if not outright disinformation. How long is the scientific community
going to tolerate such deterioration of scientific standards?
§5. Techniques of Obfuscation
In what purported
to be a search for an accurate account of events in the Gallo case,
the NIH and unfortunately the scientists who accepted to 'consult,'
or 'advise,' or 'investigate,' or to provide "oversight" for the
NIH, used certain techniques whose effect was obfuscation, not clarification.
It may be useful at this point to summarize some of these techniques,
the same thing with multiple names;
- defining responsibilities ambiguously, - complicating the structures
purportedly looking into the matter; [I list a few: "Inquiry Team,'
"Office of Scientific Integrity,' 'advisory panel,' "NIH Investigative
Committee,' 'panel of expert scientific advisors drawn from the
extramural research community" (from Raub's press release of 5 October
team of three outside scientists" (as described in Science, 12 October
- issuing ambiguous and opaque public statements to the press;
- leaving out certain documentation;
- putting in vague unattributed allegations;
- refusing to give precise information publicly under the guise
of confidentiality, some times;
- giving information (albeit vague, or disinformation) publicly
at other times; and
- talking anonymously to the press.
I usually associate
such techniques with what some lawyers do, especially when they
have a defective case. I am very concerned about what has happened
to the standards of scientific behavior when I see scientists using
Conflicting Reactions and "Reining in"
reactions arose in the scientific community, in the midst of an
atmosphere of intimidation. Both were summarized, for instance,
in the article 'Probes widen into troubles at top AIDS lab" by Bonar
Menninger (Washington Business Journal 6 August 1990). This article
stated in part:
in the NIH's investigation of Gallo's role in the discovery of HIV
is not only the scientist's reputation worldwide, but also by association
the reputation and credibility of the entire American AIDS effort
as well as hundreds of thousands of dollars in royalties flowing
both to the NIH and Gallo from patent rights on the HIV test kits...
who declined to be identified, was blunt in his assessment of
the latest investigation: "Crewdson basically laid it out, and
I think if (the NIH and the National Academy of Sciences) have
a shred of integrity, they will have no choice but to find that
Gallo misrepresented his work.
be a disgrace for the U.S. and probably quite lucrative for the
French, but it will stop the hemorrhaging of integrity.'
is convinced the case against Gallo is so cut and dried, however.
Dr. Michael Hanna Jr., director of Organinon Teknika Corp.'s Rockville-based
Biotechnology Research Institute, feels the charges against Gallo
primarily reflect the emotional atmosphere surrounding the AIDS
to wait until the investigation is complete before making a judgment,'
Hanna said. "Bob has done an extraordinary amount of outstanding
work in science and he has made enormous contributions. I'll
consider him innocent until proven guilty.'
sentiments are rare....
to be a higher authority that you answer to. An ethical standard.
Bob doesn't play that way. He plays heavy handball, and if you're
not on his team, he can make your life miserable,' said Dr. Don
Francis, a top AIDS administrator with the Center for Disease
Control in San Francisco. "He's a very powerful man. It's like
a coup in Trinidad. People aren't saying anything until they're
sure which side is going to win.'
... One of
the mysteries often noted is the almost total lack of coverage
the stories have received in the popular press, most notably the
Washington Post and New York Times.
As of Aug.
21 neither paper of record had reported on last November's Tribune
expose, the February NIH Investigation the story triggered or
the indictment of Salahuddin in late July.
with these last two paragraphs, the issue of press reporting on
the Gallo case has been a parallel issue all the way through.
Be that as
it may, when Bernadine Healy came in as Director of NIH in 1991,
she 'criticized Suzanne Hadley for running a 'satellite office'
separate from OSI quarters and operating without direction from
her superiors,' and she forced the resignation of Suzanne Hadley
from the Gallo investigation, as reported for instance in the article
'New Questions of Scientific Misconduct Cases Prompt Withdrawal
of Health Official' (New York Times, 1 August 1991). Similarly
Science (26 July 199 1, p. 372) headlined
The Head of the Gallo and Baltimore investigations has
been taken off the cases; Bernadine Healy's role in the move
prompts congressional hearing
started: 'Suzanne Hadley, who for several years has supervised NIH's
investigations of intramural AIDS researcher Robert Gallo and Tufts
immunologist Thereza Imanishi-Kari, has been taken off these two
prominent cases. Office of Scientific Integrity (OSI) director Jules
Hallum told her early this month to turn in her files from the two
investigations. Hallum, while admitting to Science that he told
Hadley he'd been ordered to 'rein you in,'
characterizes Hadley's removal from the investigations as a routine
and long-expressed personnel transfer. 'That's absurd,' Hadley says.
The irony is almost palpable. Hadley, who has spent most of the
last 4 years investigating misconduct brought to light by whistleblowers,
is now virtually a whistleblower on the office she helped found."
An aid to Dingell
at the time was quoted in the Science article as saying: 'Everything
Hadley has told us has checked out 100% against documents the committee
has received from NIH. She's obviously been treated very shabbily
in this thing.'
article 'Can OSI Withstand a Scientific Back-lash?" (Science, 6
September 1991, p. 1084) analyzed the situation further:
Yet to the
scientific community, the relative disarray of OSI's offices might
stand as a metaphor for its operations as a whole. The office is
under siege, accused by an array of critics--ranging from Healy
to an imposing collection of prominent researchers and scientific
societies--of 'appalling sloppiness and disregard for the constitutional
rights of the scientists it investigates. Indeed, hostility to OSI
has grown so overt that Representative John Dingell (D-MI), a frequent
critic of NIH misconduct investigations, has come to the office's
defense, suggesting that Congress might remove it from the NIH for
its own protection.
in this acrimonious dispute are high--perhaps higher than many OSI
critics realize. For behind a parade of familiar charges against
the office--it takes too long to complete its investigations, confidential
information has leaked to the press on several occasion, it doesn't
afford accused scientists full due process--lie deeper questions.
Can science satisfy legislators such as Dingell that it is capable
of regulating its own conduct? Does an office such as OSI stand
any chance of gaining the confidence of the community itself'? And
if OSI is dismantled or changed beyond recognition at the request
of scientists, is the community ready to live with the consequences--a
style of investigations more like a criminal proceeding.
Most of the
tensions underlying the current debate stem from OSI's attempt to
tread a fine line between investigating too hard--thus becoming
the much ballyhooed "science police'--and investigating too gently,
thereby providing an excuse for Dingell and his colleagues to create
a science police force outside NIH.
... The scientific
dialogue model was expected to appeal to scientists, but instead
it appears to infuriate them. Hallum argues that it is natural to
place the "burden of proof' on the scientist whose data is challenged.
Many scientists, however, complain that such procedures amount to
little more than "star chamber" proceedings in which subjects are
kept ignorant of the evidence against them. To ensure fairness,
they argue, OSI must give its targets the kind of protection they
would expect in a court of law.
and analysis by Science (David Hamilton) in the above article fits
all other information I have concerning events at that time.
§2. The OSI Report
A "Draft Report"
had been made while Suzanne Hadley was still on board. Subsequently,
a report by the OSI in 1992 was first leaked to the press and then
issued. Substantial parts of this OSI Report, as quoted in the press,
will be reproduced an analyzed in Part I of my response to Gallo's
The OSI Report
did not deal at all with the issue of Gallo's testimony in the patent
application for the blood test, and the question whether this testimony
included false statements concerning what isolates he had, and which
isolates could be grown in cell lines. The OSI Report dealt only
partly with the issue of misappropriation of the French virus, and
some other related issues.1
Footnotes for page 397
give two samples, B and C, out of a list ranging from A to 1, as
summarized by the subsequent ORI Report, p. 3. 1 quote from this
Misappropriation of HUT78 Cell line. The OSI inquiry and
investigation considered whether Dr. Gallo deliberately obscured
the origin of the cell line used to grow the HTLV-IIIB culture and
failed to give proper credit to Dr. Gazdar, the individual who established
the cell line ... the OSI Final Report concluded that there was
not sufficient evidence that Dr. Gallo had engaged in scientific
misconduct in this matter. However, the OSI Final Report states
that Dr. Gallo must share responsibility with Dr. Popovic for "imprecise
and non-meticulous science ......
Dr. Gallo's role in Barre-Sinoussi 1983 Science paper . The
Chicago Tribune article asserted that Dr. Gallo had misrepresented
Dr. Montagnier's research in the abstract that Dr. Gallo prepared
for a manuscript submitted to Science by Dr. Montagnier's laboratory
(F. Barre-Sinoussi et. al., Science 220, 868, 1983). The Chicago
Tribune also reported that Dr. Gallo added a self-serving sentence
to the text of the manuscript that supported Dr. Gallo's hypothesis
about the AIDS virus. . . . The OSI inquiry found that Dr. Gallo
had not engaged in scientific misconduct in this matter, but engaged
in "gratuitous, self-serving, and improper act."
that Gallo was not guilty of "misconduct' on any count. The final
conclusion of OSI regarding the issue of accidental contamination
versus deliberate misappropriation of LAV was that 'resolution of
this question is not possible based on information available or
obtainable by OSI.' As summarized by the subsequent ORI Report (December
1992, p. 3), the "Overall Conclusions" of the OSI Report were as
the OSI did not make a finding of scientific misconduct against
Dr. Gallo based on the issues raised by the Chicago Tribune
article, members of the OSI inquiry and investigative teams were
concerned throughout the deliberations by the numerous instances
in which Dr. Gallo's behavior appeared to be less than collegial
and decidedly beneficial to himself and his causes. The OSI cited
examples of Dr. Gallo altering the scientific content of published
papers purporting to describe data previously presented orally to
favor his own purposes, the inclusion of statements in the Barre-Sinoussi
paper without the unequivocal agreement of the authors, the misleading
statement regarding LAVs growth in a permanent cell line, and inaccurate
reporting of the origin of the HT and H9 cell lines. However, the
OSI did not find that Dr. Gallo committed scientific misconduct.
Healy stated publicly that Gallo was "absolved" by the OSI Report.
"Dissent and Critique" by Suzanne Hadley
Within a short
time, Dan Greenberg's Science and Government Report (1 June 1992)
published excerpts of a 'strong rebuttal" by Suzanne Hadley,
stating in part:
The NIH Office
of Scientific Integrity (OSI) "Final Report' concerning Dr. Robert
Gallo's research on the AIDS virus is a deeply flawed document reflecting
an incomplete investigation. The report has been substantially 'watered
down" from the hard-hitting draft report.
apparently damaging to Gallo, including some of his own testimony,
has been deleted. Specious, unsubstantiated arguments adduced by
Gallo and his colleague, Mikulas Popovic, have been accepted unquestioningly
by OSI. The OSI even constructed its own arguments exculpatory to
of the OSI arguments and conclusions cannot be substantiated; a
number are flatly refuted by the evidence. Moreover, in a number
of instances, OSI has failed to deal with and even mention highly
significant pieces of evidence known to be in its possession. Perhaps
most serious, the final OSI report gives only superficial, misleading
consideration to the implications of the highly significant virus
sequencing studies. As a result, the OSI has irresponsibly evaded
the central question in the entire investigation, the question of
Gallo's possible misappropriation of the Institut Pasteur HIV isolate,
transmittal letter [to Assistant Secretary of Health James 0. Mason]
for the final report compounds the damage by asserting claims on
behalf of Gallo that go well beyond anything in the OSI draft and
that, in any event, cannot be substantiated. Most notably, she has
asserted that Gallo had other AIDS virus isolates contemporaneous
with LAV, with the implication that Gallo had no motive to misappropriate
the French virus, and that there is no evidence to support possible
misappropriation. These assertions are false....
many significant unaddressed questions are the following:
(1) How did
Gallo's virus (HTLV-IIIb) come to be the same as the Institut Pasteur
virus, LAV? How could there have been an innocent contamination,
given Popovic's statement to Gallo that "the development of [HTLV-IIIb]
was almost entirely confined to a room 'where no LAV was ever used"?
(2) How did
Popovic's "mystery virus," MOV, come to be the same as the Institut
Pasteur virus? Was there ever a real MOV virus, or was this merely
another name for LAV?
(3) Why was
there no sign of any virus in the earliest available sample of HTLV-IIIb?...
have other isolates available to him to establish the cause of AIDS
and develop an HIV blood test? In other words, did Gallo have a
motive to misappropriate the French virus?
In this connection,
it is not adequate to claim in the abstract, as the OSI leadership
and Healy have done, that "Gallo had other isolates."
No one questions
that Gallo eventually had AIDS virus isolates. But the crucial question
with respect to whether Gallo had a motive for misappropriation
are: Did he have isolates at the crucial time, i.e. prior
to and during the period in which he was growing the French virus,
and were any Gallo isolates useful for the crucial early experiments?
The OSI has evidence in its possession demonstrating clearly that
the answer to these is no.' This certainly does not prove that Gallo
rnisappropriated the French virus, but it clearly shows that he
did have a motive for misappropriation. But the OSI did not report
the determination in the final report, the OSI altered and deleted
(and presumably, ignored) a number of pieces of evidence contained
in the draft report....
a series of specific points which are rather technical and which
there are strong indications that OSI, whether through negligence
and/or lack of will, did not identify or pursue several potentially
vital issues associated with Gallo/Popovic's experiments with LAV
and HTLV-IIIb, and how those experiments were reported in the scientific
literature. The evidence concerning these issues is in OSI's possession:
it includes evidence that indicates there may have been willful
misrepresentations to OSI on the part of some of its witnesses.
The question about possible false statements to OSI will be dealt
with by appropriate authorities. But OSI's failures have left unexamined
the scientific implications of the possible falsehoods.
A month later,
on I July 1992, Science and Government Report provided some information
about the effect of Suzanne Hadley's "dissent and critique' and
attempts by NIH to shut her up:
On June 3,
following publication of excerpts from Hadley's assessment in SGR
[June 1, "Report 'Absolving' Gallo Draws Strong Rebuttal'], Mason's
chief for misconduct matters, Lyle W. Bivens, asked Dingell's staff
to help him review the NIH report. The request was accompanied by
32 questions derived from Hadley's critique. Bivens heads the Office
of Scientific Integrity Review, which advises Mason on misconduct
by Hadley, who has been on medical leave since March 2, NIH has
formally directed her to shut up.
In a letter
on June 8 from Bonnie R. Kalberer, Acting Director of the NIH office
of Science Education Policy, Hadley was told that 'you may not make
statements to or appear before the media regarding matters relevant
to the NIH unless any such activities are cleared in advance by
me or my supervisor, Dr. Jay Moskowitz.' Healy had previously asked
the FBI to investigate Hadley's role in leaks of information from
NIH misconduct studies, but the Justice Department declined that
assignment as unwarranted.
The NIH gag
order specifically referred to statements Hadley reported in Chemical
& Engineering News of May 11 and a report in Science
of May 15 stating that Hadley is 'now working part time for Representative
Dingell....' It also noted that she has appeared on the TV program
§4. What Did Gallo's Laboratory Have and When
I shall now
address the question what "isolates' were present in Gallo's laboratory
and when. Systematically, in Raub's press conference of 5 October
1990 (supported by the Richards Panel), in the OSI Final Report,
and in the subsequent ORI Report, it was promulgated that because
Gallo's laboratory had many other "isolates' of the so-called AIDS
virus, he had no motive to misappropriate the Institut Pasteur's
isolate LAV. I shall analyze the merit of this contention, as well
as the way the OSI and ORI Reports mentioned or did not mention
facts pertaining to this question. I rely on Suzanne Hadley's 'Critique"
of the OSI Report, as well as her 43-page analysis: 'THE ORI 'GALLO'
REPORT--Misappropriation or Contamination?'
Were the isolates
used by Gallo in the cell line for the blood test the ones sent
to him by the Institut Pasteur in 1983? The answer is yes, but it
is buried in technical terms on page 37 of the OSI Report in the
sentence: "By April 1984, HTLV-IIIb cultures contained only the
NXB2/LAI sequence (AI9-A21A).' The answer to the question could
have been expressed in plain, ordinary language, but was not.
One of the
ways NIH has systematically given a false impression is by repeated
statements to the effect that Gallo had 'detections" and 'isolates."
In this connection, I have already quoted the Raub press conference
of 5 October 1990. I shall now quote from the OSI and ORI Reports.
OSI Final Report p. 7. '... the deliberations at the September
1990 meeting of the NIH consultants included the determination
that the inquiry had resolved certain of the allegations and issues
or shown them to be without substance. Specifically, it was determined
that Dr. Gallo had a substantial number of HIV detections and
isolations from several different sources at the time HTLV-IIIb
and LAV were being grown in his laboratory.'
ORI Report, p. 16. 'By February 22, 1984, the LTCB had accumulated
enough information on the isolate RF such [sic] that it could
have been used for development of the AIDS blood test with modest
delays relative to the HTLV-IIIB timeline.'
ORI Report pp. 26-27. 'If HTLV-IIIB had been found unsuitable
for the blood test, RF could have been used in about three weeks.
LS, BK, and possibly other isolates, in about 'three to six weeks,
or something like that.,2
The ORI concludes that isolates other than MOV and HTLV- IIIB
were available in the LTCB that could have been used to develop
the blood test on a timeline that would have been only slightly
behind that used for the development of the HTLV-IIIB-based test.
RF, at least, could have been used with only a minimal delay.
In the first
place, the OSI's assertion is objectionable because of its imprecise
reference to 'the allegations.' Whose allegations? (Cf. the Appendix
of the preceding section.) I object to the innuendo that Crewdson
was responsible for making such vague allegations. If the OSI Final
Report did not refer to Crewdson implicitly, then to whom did it
The OSI's assertion
to have been meaningful should have specified at least:
- what kind
- what these isolates could be used for; and
- at what time did Gallo have these isolates in his laboratory
What is the
meaning of "isolates' and "detections'? Did Gallo
Footnotes for page 402
ORI Report here has a footnote, 'Popovic 6/26/90 at 78,' indicating
that it is quoting testimony by Popovic.
and 'detections' in a form which could be useful for the development
of the blood test or specifically in a form which could be grown
in large quantities, independently of the French virus?
Unless a date
is given for the time when Gallo had or did not have "isolates,"
the so-called 'determination" misrepresents what OSI calls 'the
allegations." Was it in the crucial period October 1983 to January
1984, when Gallo was growing the French 'AIDS" virus in a cell line?
In this connection, it must be recalled that Gallo did his:first
Eliza HIV blood test in January 1984, with the French virus. Gallo
has asserted that he didn't know the virus he was using was in fact
the French virus.
other viruses in Gallo's lab? One of Gallo's own isolates was called
RF. In the OSI Final Report, we find the following statements concerning
28: 'Isolate RP was a strong contender to be used for the HIV
blood test in early 1984. The notes documenting the growth and testing
of RF appear complete and generally clear. RF was given special
attention by Betsy Read-Connole, who, when she saw the cells dying
in December 1983, mixed RF in primary lymphocyte culture with HUT-
78. The RF/HUT-78 culture rapidly exhibited a strong cytopathic
effect, but Ems were negative or equivocal....'
p. 29: 'In June of 1984, RF was used to infect the H9 cell
line, and in the fall of 1984, the infected cell line was transmitted
to the Frederick, Maryland, facility for mass production. RF is
a notable example of an HIV isolate grown in the LTCB at about
the same time as HTLV-IIIB and LAV. It is particularly noteworthy
because of its high titer, its pronounced cytopathic effects,
and its distinctiveness from HTLV-IIIB. Given these qualities,
it is surprising (and from Dr. Gallo's perspective, perhaps regrettable)
that RF was not chosen for use for developing the HIV blood test,
especially since it was from a single individual and not a 'pool."
Dr. Gallo told the inquiry team that the reason HTLV-IIIB was
chosen over RF for the blood test was because RF came from a Haitian
donor, while the pool was drawn exclusively from domestic donors.
A more significant reason for the decision may have been that
the pool virus was slightly ahead of RF in its growth and testing
analyze point by point how these statements make the
OSI Final Report
1. Gallo's explanation why the Haitian donor was not chosen,
namely the claim that "the pool was drawn exclusively from domestic
donors," is false: The pool had two non-American donors. That OSI
in its Final Report reproduced such a purported explanation by Gallo
without at the same time recording that Gallo's statement is false
misinforms readers and documents the unreliability of this Final
In light of testimony to OSI by Gallo and Popovic concerning
their own isolates, it should not have been 'surprising' to OSI
that "RF was not chosen for use for developing the HIV blood test."
But in its Final Report, OSI fudges the truth and suppresses evidence.
The words 'may have been' and "slightly ahead" do not properly represent
the situation at the crucial time October 1983 to January 1984.
During this period, which may be viewed as the crucial period, whatever
isolates or detections Gallo had on his own were not used and could
not be used because they were not good enough, for various reasons.
One of the reasons was that only the isolate from the Pasteur Institute
virus could be grown continuously in a cell line within this period.
Some of the testimony by Popovic to that effect was reproduced in
the OSI Draft Report of June 1991, but was suppressed in the Final
Report. For instance, pp. 45-46 of the 1991 Draft Report, we find
the much more explicit statements:
said he favored use of the RF isolate because "individual isolates
were under more strict control in (a) more organized lab' and because
'the origin of it was more clear and under better conditions (12/l/90
interview, transcript pages 109-110). However, RF was somewhat behind
IIIB in its culturing and growth; Dr. Popovic said that "in order
to be in a good position to go with RF, we needed at least four
weeks of work to concentrate on that one and that wasn't done' (22/l/90
interview, transcript page 116). Thus, it appears that when the
decision was made to move ahead the submission date for the Science
papers, HTLV- IIIB became by default the choice to be featured in
the Popovic et al. paper.)
to state that the reason why RF was not used "may have been' that
"the pool virus was slightly ahead...' is a misrepresentation. The
pool virus WAS (not 'may have been") chosen by Gallo because according
to Popovic's testimony, the other isolates were not adequate for
Gallo's purposes at the time.
The time-frame June 1984 to fall 1984 mentioned on page 29 of
the OSI Final Report is misleading because Gallo wanted to use an
isolate for continuous growth in a cell line in the period October
1983 to January 1984, "to move ahead the submission date for the
Science papers,' and for use in the blood test before June 1984.
conclusions from the Office of Research Integrity (ORI) concerning
RF were similarly flawed. Suzanne Hadley wrote critiques both of
the OSI Report and the ORI Reports. In both critiques she addressed
what did Gallo have and when, especially concerning RF. To avoid
being repetitive, in the following appendix to this section, I shall
quote from her analysis of the ORI Report. Matters are technical,
and she has the background to know certain facts.
analysis by Suzanne Hadley:
THE ORI "GALLO" REPORT
Misrepresentation or Contamination?
It is unclear
why ORI chose 22 February 1984 as the cutoff date for its claim
about the quality of the LTCB's information on the RF isolate. In
any event, the claim is baseless, for the 'information' on RF the
LTCB allegedly had accumulated, as detailed by ORI, is incomplete,
unsubstantiated, and incorrect.
ORI has relied on unsubstantiated claims of LTCB scientists; at
the same time, ORI ignores evidence, for which considerable documentation
exists, that runs counter to the point ORI apparently is trying
1. Page 16: "RF was ... transmitted to a permanent cell line
... in mid-December, 1983" and '... in December 1983, RF induced
the giant multi-nucleated cells associated with the cytopathic effect
of the AIDS virus." Page 27: 'By Christmas 1983, Ms. Read-Connole,
a technician, demonstrated that RF could be grown in HUT-78, thereby
giving LTCB a cytopathic virus with a documentable origin that could
be continuously grown in a permanent cell line."
The fact is that RF was not transmitted to anything in December
1983. Rather, according to Read-Connole's testimony to OSI, HUT-78
cells were mixed with the existing RF culture, around the
middle of December,
when she observed that the culture was rapidly dying.'
heavily on other aspects of Read-Connole's testimony, but failed
to mention her testimony concerning the imminent demise of the culture
in December 1983. Likewise, ORI ignores the notation in Read-Connole's
laboratory notebook, dated January 10, 1984: "Cells co-cultured
after 2 months in culture,' i.e., by mid-January. It is clear that
by Christmas 1983, all Read-Connole could have known was that the
culture was still alive. In other words, there was no evidence,
by Christmas 1983, that "continuous growth in a permanent cell line"
had been achieved. ORI's claims are contradicted by all the available
2. There are no data or notes to support Read-Connole's claim about
the presence, in December 1983 of 'giant multinucleated cells.'
Moreover, the existence of "the AIDS virus' had not been demonstrated
by December 1983, nor, obviously had the presence of giant multi-nucleated
cells been seen to be characteristic of infection with this virus.
Thus, even allowing for the possibility that giant multi-nucleated
cells were observed in the RF culture in December 1983, it is nonsense
to suggest, as ORI does, that Gallo et al. understood this phenomenon
to be "associated with the cytopathic effect of the AIDS virus."
3. ORI claims that "RF was RT positive.' There are no primary data
to substantiate this claim. In fact, as noted in the Critique of
the OSI Final Report: "Inexplicably, RT assays reportedly were not
done for at least the first two-to-three months of RF culturing."
Read-Connole's notes, dated January 10, 1984, state concerning RF:
'Initial cultures negative for p 19, RT and EM.' Gallo himself,
in his response to OSI's queries on the May 1984 Popovic et al.
Science paper, confirmed that early RTs on RF were not done: "Assays
for reverse transcriptase activity in the supernatants of early
cultures of RF were not done.' When queried further about this matter,
Gallo attributed the absence of RT data on RF to 'an enormous backlog
of RT samples to be run in Dr. Sarin's laboratory during the period
of the RF cultures." Yet according to Dr. Popovic and Ms. Read-Connole,
by the time RF was in culture, it was Dr. Sarngardharan, not Dr.
Sarin, who was performing RT assays for the LTCB, because Dr. Sarin's
assays had earlier proven to be seriously unreliable.
4. ORI says that 'IFA:s [sic] indicated that rabbit antiserum and
AIDS patient serum reacted with RF infected cells.' In making this
claim, ORI fails to state that prior to the end of February, the
IFA data on RF were, at best, marginal. ORI fails to cite the data
in Read-Connole's notebooks and summarized in the critique of the
OSI Final Report, data that by Read-Connole's own account, showed
the RF IFA positive reading was only minimal.
ORI fails to give any attention whatsoever to the paradoxical, persistingly
negative EM data on RF. By Popovic's own account (November 28, 1984
Popovic-to-Gallo memorandum titled "Documentation of Chronological
Detection and Isolation of HTLV-IIIRF'), the lack of
EM evidence" for RF was the reason that Popovic chose to use the
'pool' isolate rather than RF for the LTCB's HIV blood test. Popovic's
memorandum actually details a number of reasons why RF was not chosen,
was not even a viable candidate for the blood test (see below),
but the fact is that as late as October 1984, Gallo et al. had no
positive EM data on RF; yet in the Popovic et al. May 1984 Science
paper, RF was reported as EM positive.
its report, ORI notes 'that the National Academy of Sciences consultants
to NIH (the 'Richards Committee") criticized Gallo for having unilaterally
decided, over the expert opinion of the electron microscopist, that
RF was EM positive. But the Richards Committee critique on this
point is not mentioned in ORI's recitation of the evidence that
it apparently believes sup ports the viability of RF as a candidate
for a blood test, pointing once again to the curious lack of coherence
of the ORI Report, not to mention ORI's convenient propensity for
ignoring evidence that runs contrary to its themes.
Such information as was available on PF throughout the Spring and
Summer of 1984 indicates clearly that RF was at all times significantly
behind the 'pool" virus, as well as MOV and LAV, as a potential
candidate for an AIDS blood test. Besides the numerous significant
negative, nonexistent, and marginal readings on R.F, as cited above,
it also is the case that:
was not put in the LTCB's 'best grower' clone, H9, until June 1984;
to this time, Gallo et al. had no idea how well-or even if--RF was
capable of producing large quantities of high titre virus. RF was
not sent for large-scale production (an intermediate step preliminary
to "mass," commercial-level production) until, reportedly, 'around
the end of November 1984.' (Actually, this date is questionable;
probably it is too early, for Popovic's November 28 memorandum notes
that 'At the present time we are intensively pursuing the single-cell
cloning and superinfection of H9 cells and other target cells to
achieve 80% to 90% positivity for HTLV-IIIRF," which step, Popovic
says, "should be accomplished within a few weeks."
As late as
April 1985, RF was available only in cases of 'urgent need,"
due to the presence of mycoplama in the large-scale production cultures.
to Electro-Nucleonics, Inc., the laboratory in charge of RFs large-scale
production, as of April 1985, the laboratory did not expect "to
have a mycoplama-free culture" for several months. Thus, even this
late, RF was useable for very little Indeed.
was never used as the antigen in an AIDS virus antibody blood test,
an absolutely essential step in selecting an isolate for the test.
Gallo et al. had no idea whether RF would be useful for reliably
and discriminably identifying antibodies to the AIDS virus.
For RF to have
been a viable competitor to IIIB for use in the LTCB blood test,
all the above steps would have had to be successfully accomplished.
It would have required a minimum of several weeks to even attempt
these experiments-, even then, there was no guarantee that they
would succeed in a timely fashion. In fact, the available evidence
strongly indicates the contrary. ORI's claim that "RF could have
been used for development of the AIDS blood test'-like the comparable
claims of Gallo et al. is speculative and entirely unsubstantiated.
(d) Newly discovered evidence indicates that at least the
initial culture of RF was not a satisfactory grower. Specifically,
in July 1985, at a meeting of the NCI Vaccine Development Group,
there was discussion of the problematic growth of 'M,' which had
been sent to the Fredrick facility, presumably for mass production
for work on an AIDS vaccine. Minutes of the July 1985 meeting show
that the participants who included Dr. Popovic, agreed that RFI
should be replaced with 'RFII," not otherwise described except as
being available from Dr. Popovic.
showing that 'RFI' was a less than optimal grower bears out the
testimony to OSI of Dr. Larry Arthur, chief of the laboratory at
the Frederick Cancer Research Center that mass produced virus for
Gallo. According to Arthur, RF, which he received 'well after' he
first received the "pool' virus, 'was a lower producer than the
IIIb in our hands' (1/28/91 interview; annotated transcript pages
In short, the
totality of the evidence concerning RF flatly refutes ORI's (and
Gallo's) contention that RF could have been used for the LTCB's
HIV blood test. ORI's treatment of the issue is inaccurate and incomplete;
its conclusions cannot be substantiated.