The Gallo Case - Part 1    Part 2  Part 3  Part 4  Part 5

Part 1 - Contents
Introduction  p 365
Investigations of Gallo  pp 365-367
The Role of Scientists  pp 367-368
I.   THE CREWDSON ARTICLE  pp 369-374
II.  THE NAS-NOMINATED PANEL  pp 375-378
III. THE OSI "INQUIRY"  pp 379-384
IV. INTERLUDE: SCIENTIFIC RESPONSIBILITY  pp 385-393
V.  THE OSI INVESTIGATION  pp 394-408

Note: Page numbers refer to corresponding pages in the paperback edition of the book "Challenges"

Introduction  

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."

Investigations of Gallo

The Chicago 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 emulate.

Investigations 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. 

  2. The 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 report.

Footnotes for page 366
¹ This 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).

Because 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. 

The Role of Scientists 

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.

  (a) 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.

  (b) 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 by lawyers.

  I regard 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.

  (c) 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.

  (d) 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.

Different scientists reacted differently at different times, so no universal characterization applies to all of them for all times. 

I. 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. 

Misappropriation 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
¹Crewdson's 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.

A question 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 virus. 

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." 

Information which came out subsequently confirmed Crewdson's documentation. Specifically:

   (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 Staff Report.

   (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 reproduced below.

See especially 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. 

Gallo's 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: 

Footnotes for page 372
² Haddow 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: 

Crewdson's article went on to relate in detail certain internal contradictions in all the memos going back and forth in 1985. 

Anticipating 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) 

Ultimately, the HHS Inspector General's Memorandum of 10 June 1994 reported (p. 27, see XV. §4 below):

"The [Patent 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." 

These facts were confirmed in the Dingell Subcommittee Staff Report (see XVIII). 

II. THE NAS-NOMINATED PANEL 

Under pressure 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." 

Frank Press 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." 

The nomination 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. 
 

The nominated panel was chaired by Fred Richards, Professor of Molecular Biophysics and Biochemistry at Yale. The other members of the panel at the time were: 

[Shortly thereafter, Stanley Falkow and Harry Gray dropped out.] 

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 needed. 

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....' 

William Raub 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. 

An announcement 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. 

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 muddle.' 

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
¹ Press 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, p. 16.
"NIH Bolsters Claim of AIDS Pioneer," Washington Post, 6 October 1990
    'AIDS probe shifts to next gear,' Chicago Tribune, 7 October 1990, p.19.
'Gallo Inquiry Takes Puzzling New Turn,' Science, 12 October 1990, p. 202.
'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.

precise meaning. 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: 

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: 

Aside from 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. 

Finally, Raub 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

patent from 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. 

Subsequent 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 Institute.' 

This public statement is misleading on at least two counts, and is false if one makes more precise certain time periods alluded to in the statement. Indeed: 

- 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.

Appendix 

From Crewdson's article
"Health official reaffirms issues in AIDS lab probe"
Chicago Tribune, 28 October 1990, p. I 

... According 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 have said." 

... 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. 

"There were 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." 

Raub agreed, 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.'; 

 

IV. 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. 

§1. Whatever-It-Is 

Obviously William 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? 

Another ambiguity 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: 

This multiplicity 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" or "committee.' 

§2. 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:

(a) In 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: 

(b) In 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: 

(c) 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: 

(d) In a 28 October 1990 Chicago Tribune article, James Warren wrote: 

Therefore Fred 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.

 

§3. Evasion of Substantial Issues 

Invoking the "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 'investigation," etc. 

- another type having to do with the merits of the Gallo case: What did he have and when?
 
- a third type having to do with public statements by the higher-ups. 

For example, 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. 

§4. 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: 

Fred Richards 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 organizations "weaknesses"? 

About communicating with the press and the media Feynman wrote: 

There is also the passage where Feynman relates how he objected to some recommendation in the Commission Report.

William P. 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: 

No question here who is taking responsibility for what. 

Feynman's model 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, documented above: 

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 these techniques.
 

V. THE OSI INVESTIGATION 

§1. Conflicting Reactions and "Reining in"
Suzanne Hadley 

Conflicting 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 connection 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 

OSI Investigator "Reined In"
The Head of the Gallo and Baltimore investigations has
been taken off the cases; Bernadine Healy's role in the move
prompts congressional hearing

The article 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,'

nevertheless 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.' 

A subsequent article 'Can OSI Withstand a Scientific Back-lash?" (Science, 6 September 1991, p. 1084) analyzed the situation further: 

The reporting 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 letter below. 

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

¹ I 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 ORI Report: 

B. 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 ...... 

C. 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."

OSI judged 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 follows: 

NIH Director Healy stated publicly that Gallo was "absolved" by the OSI Report. 

§3. "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: 

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: 

§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. 

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 refer? 

The OSI's assertion to have been meaningful should have specified at least: 

What is the meaning of "isolates' and "detections'? Did Gallo


Footnotes for page 402
² The ORI Report here has a footnote, 'Popovic 6/26/90 at 78,' indicating that it is quoting testimony by Popovic. 

have 'isolates" 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. 

What about 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 RF: 

   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 Report. 

  2. 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: 

Therefore, 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. 

  3. 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. 

The subsequent 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. 

APPENDIX 

From the analysis by Suzanne Hadley:
THE ORI "GALLO" REPORT
Misrepresentation or Contamination?
pp. 19-23 

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. 

Once again, 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 to assert. 

Specifically:

   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.'

ORI relied 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 evidence. 

   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. 

  (b) 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-III_RF'), 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. 

Elsewhere in 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. 

  (c) 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: 

  1. RF was not put in the LTCB's 'best grower' clone, H9, until June 1984; 

  2. Prior 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.

According 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. 

  3. RF 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. 

The evidence 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 19-20). 

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.