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

Part 4 - Contents
XIII.   Interlude: Motives, Intent, and Misconduct  pp 523-527
XIV.  The Dingell Subcommittee  Hearings of 21 July 1993  pp 528-530
XV.   The HHS Inspector General, The U.S. Attorney, and the IG's Memorandum  pp 531-541
XVI.  Developments February-July 1994  pp 542-554

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

XIII. INTERLUDE: MOTIVES, INTENT, AND MISCONDUCT

I shall now add my own comments on "motives and intent," as well as "misconduct." Both in the Baltimore and the Gallo cases questions of motives, intent, and misconduct were brought up. Notably, the HHS-ORI Report of 30 December 1992 dealt repeatedly with Gallo's "intent" in dealing with the French AIDS virus. For example, concerning the statement in the paper for which they charged Gallo with "misconduct," this report stated: "Gallo intended the statement to deceive others regarding the growth of LAV."

On the other hand, the Appeals Board issued the ruling: "The key issue here, however, is whether Respondent reasonably could have anticipated at the time of the alleged conduct that such conduct, if proved, would constitute 'scientific misconduct.'... Even assuming Respondent engaged in the alleged conduct, this fact alone would not impugn Respondent's research integrity. If this integrity is not impugned by the conduct, no administrative action to protect the federal government interest is needed or appropriate; and applying the label to Respondent in such circumstances would be fundamentally unfair." This ruling of the Appeals Board is quite remarkable in several ways. For example, suppose the following conditions prevail systematically in the laboratory of a scientist working for the government:

A major question as I, and certainly some (how many?) other scientists see it, is not whether to apply "the label" of "scientific misconduct" to a person. Rather, we ask the question whether defective scientific practices are to be tolerated.

Of course, accidental mistakes may occur. They happen to all scientists, as we all know. When is a "pattern of behavior" sufficiently systematic to merit administrative action (which one?) by persons ultimately responsible for laboratories, or to merit censure by scientists? The answer, as far as I am concerned, is not a matter for legal adjudication. It is a matter for open discussion, based on the public availability of facts, which I expect to be made available through suitable investigations by the agencies on which the laboratories depend.

As much as I agree with the ORI Report and the Richards Panel that Gallo's misrepresentations denying credit to the French could not be tolerated by the scientific community without expressing some objections on the record, I do not agree that the determination of motives or intent is necessary to evaluate a professional performance. Persons have a way of adjusting their psychology so that intent and motives are perceived differently by themselves or others at different times.¹ Going into motives or intent results in a morass of differing interpretations and psychological analyses according to diverse views of psychology. As a result, going into motives and intent detracts from looking at facts.

Similarly, I object to tying the entire investigative enterprise to a determination of "misconduct" rather than a determination of facts in the case, with the result that if no "misconduct" in the above legalistic sense is found, then "no administrative action is needed." Linking the investigative process to a determination of "intent" or "misconduct" obfuscates the possibility of determining and making clearly known the facts of the case. Actually it has been documented to destroy this possibility in certain important aspects.

The ORI Report did not need to go into "intent" to determine that Gallo did something which would not be tolerated by HHS. Indeed, as far as I am concerned, the ORI Report and memoranda within NIH gave facts which do not need to be supplemented with a determination whether there is "intent" or "misconduct," but these facts often got lost in the shuffle, as when for instance


Footnotes for page 524
¹ The ORI Report was criticized by others for dealing with "intent." Science (8 January 1993) reported: "Former OSI Director Jules Hallum, an investigator on the Gallo case, says, 'the ORI Report is filled with statements about what Gallo intended. How did they get into his mind?'"

Nicholas Wade in the New York Times represented Gallo as a martyred saint. Some of these facts, among others, are:

What is "misconduct" anyhow?. At which point are people ready to use words such as "fraud" or "misconduct" to describe certain actions? At different points for different people at different times in different circumstances, of course. But why link the questioning of experiments and data to charges of intent or motives? There are many forms of conduct which are undesirable in science:

We find the determination of "intent" and "motives" as substitutes or principal criteria for evaluating performance both in the Gallo and in the Baltimore cases. The New York Times of 6 October 1990 quoted Dr. Streicher, "a spokesman for Dr. Gallo," as saying: 'There was no need to use the French strain, and therefore there was no intent to commit any misconduct. That makes the ethical question moot.

"I question Streicher's reference to "need." Need for what? To grow the so-called "AIDS virus" continuously in a cell line? Existing documentation indicates there was such a need. I object to the logic of Streicher's "therefore."²

When the Appeals Board issued its rulings, it rendered moot the ORI Report, and shifted the focus of attention from science to legalisms. Facts about the case, whether those available or those withheld by NIH and HHS, became secondary. We shall analyze this aspect further in connection with the decision of the U.S. Attorney not to prosecute, following the HHS Inspector General's investigation.

It is for the scientific community to decide whether to accept a deterioration of standards, or to stand firm against such a deterioration.

Therefore:

Rather than looking into motives and intent, and determining "misconduct" in some legalistic sense, let us raise questions about performance concerning:

I urge that questions about conduct concentrate on facts concerning performance, and not on arguments as to what constitutes "fraud," "intent," or "misconduct" and how these words are to be used. Once facts are established, the scientific community can arrive at de facto decisions: whether to tolerate certain practices or not, whether to fund certain laboratories or not, whether to rely on claimed results by certain persons or not. But even though one does not wish to tolerate a practice, this does not imply that the practice has to be labeled fraud or misconduct.


Footnotes for page 526
² Streicher's type of argument was also used in the Baltimore case. For instance, in the 9 June 1990 Economist we find: "But she [Imanishi-Kari] has put forward one argument eloquently, which Dr. Baltimore has sympathetically repeated: what possible motive could she have to cheat?... If scientists were other than human, this might be a good argument. If scientists had not in the past invented data to support conclusions that they believed, but could not yet otherwise prove, it might have some weight. But they are human, and it has happened before."

It does not imply that the practice has to give rise to legal or quasi-legal proceedings. Rather, let us have official reports clearly informing us of the facts in the case.  
 

XIV. THE DINGELL SUBCOMMITTEE HEARINGS OF
         21 JULY 1993

I reproduce in full below the opening statement by Dingell at the hearings for Lowell T. Harmison

OPENING STATEMENT OF THE HONORABLE JOHN D. DINGELL, CHAIRMAN SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 
WEDNESDAY, JULY 21, 1993

The hearing today is part of a Subcommittee investigation that bears directly on the integrity of public service and the integrity of the scientific enterprise.

In April 1984, the U.S. Government announced with great fanfare that government scientists had discovered the virus that was the cause of AIDS and developed a blood test to detect antibodies to the virus. These developments were heralded by Health and Human Services (HHS) officials at the news conference as "a triumph of science" and "another miracle" added to "the long honor roll of American medicine and science." Eventually, the U.S. Government received a patent on the blood test; numerous other related patents were applied for and received.

No sooner was the HHS announcement out than suspicions followed by outright concerns, were heard to the effect that:

(1) the U.S. Government scientists' supposed "discovery" was not their own; these scientists actually "discovered" another scientist's virus and used it for their putative breakthrough; and

(2) the U.S. Government had engaged in "inequitable conduct" before the United States Patent and Trademark Office, having seriously failed in its duty of disclosure to that office.

In 1985, these matters erupted into a full-blown patent dispute, a dispute that extended for nearly two years, through no less than four legal proceedings, culminating in a negotiated settlement. This settlement has come under increasing criticism as its factual underpinning have evaporated.

Even after the settlement, the controversy did not die. Within the scientific community, there were continuing concerns about possible improper conduct in the National Institutes of Health (NIH) laboratory of Dr. Robert Gallo. Significant questions about what information was provided to--and withheld from--the U.S. Patent Office remained unresolved. And it was not long until evidence began to appear that strongly challenged U.S. Government actions during the patent dispute.

Today, as the Subcommittee nears the end of its investigation of this matter, an investigation hindered and greatly prolonged by continued obstructionism at the NIH and elsewhere, there is substantial evidence of problems in, and there are serious concerns about, the government's handling of the matter:

(1) It is now clear that the virus used to make the United States HIV antibody blood test is the virus discovered by scientists at the Institut Pasteur. Moreover, the cell line used to grow the virus was the cell line discovered by a scientist at yet a third laboratory. After years of denial, it is absolutely clear that both the virus and the cell line that were claimed as new discoveries of the U,S. Government scientists were actually those of other scientists and merely given new names.

These are not the Subcommittee's judgments; they are the judgments of the scientific community. In the case of the virus, the findings were confirmed in a paper published in the prestigious journal Nature, just a few weeks ago.

(2) When the U.S. Government sought a patent on its alleged "discoveries" relative to the HIV blood test, officials apparently withheld from the U.S. Patent Office information directly and materially relevant to the examination of the Government's patent applications--information showing the claimed invention actually had been made long before by other scientists.

(3) Senior HHS officials, as well as HHS and DOJ attorneys, apparently possessed evidence at the time of the patent dispute that, at a minimum, pointed to very serious doubts that the U.S. Government's patent claims could be substantiated. But international prestige and significant financial rewards apparently made defense of the U.S. patent paramount. Consequently, these U.S. Government officials may have willfully ignored and, in some instances, actively suppressed that evidence.

Also, as the Subcommittee investigation has proceeded, we have encountered repeated instances of obfuscation and obstructionism on the part of past and current Government officials that suggest a certain reluctance to confront the facts. Documents have been destroyed.

Documents have been withheld for protracted periods. In several instances, the documents known to exist have never been produced from the official Fries. And some witnesses have refused to appear voluntarily.

The hearing today is necessary only because Dr. Harmison, a key figure in the events under review, has chosen not to cooperate with a Subcommittee request for a staff interview. This lack of cooperation has not been tolerated in the cases of the Environmental Protection Agency or the Department of Defense witnesses in the past and it cannot be ignored in this instance.

The Subcommittee is at a loss of understand why routine cooperation was not possible here, and the absence of a staff interview creates a great deal of uncertainty as to what information will be received today. Because of this uncertainty, and out of an abundance of caution, without objection the Subcommittee determines that the testimony "may tend to defame, degrade, or incriminate any person" and, under Rule XI(2)(k) of the Rules of the U.S. House of Representatives, the hearing will be closed to the public. The chair notes that a quorum to take testimony is present, as required by that rule. Other Members will be recognized for opening statements and then there will be a brief recess to clear the room. After that we will proceed to administer the oath to Dr. Harmison and receive his testimony.  
 

XV. THE HHS INSPECTOR GENERAL, THE U.S. ATTORNEY,
       AND THE IG'S MEMORANDUM

According to Suzanne Hadley who headed the NIH-OSI Gallo investigation before being forced out by Bernadine Healy, the OSI did not consider questions having to do directly with the patent application, because OSI was advised by the HHS Office of the Inspector General that such questions might require a criminal investigation. Similarly, the ORI did not consider such questions.

§1. No Prosecution

The Inspector General did carry out an investigation. It found sufficient cause to present a case to the U.S. Attorney's office in Baltimore, MD. In January 1994, the U.S. Attorney's office declined to prosecute the case, and wrote a letter dated 10 January 1994 to the HHS Inspector General to inform the IG of the U,S. Attorney's position.

This letter addressed several issues: legal technicalities and legal concerns, the previous history of the ORI case, the validity of the ORI case, the legitimacy of the patent application, the legitimacy of the royalties, and responsibilities on a broader basis (HHS, the scientific community, the government, and the "court of public opinion"). I shall now give a summary of the letter.

(a) Legalistic reasons for the U.S. Attorney's office not to prosecute. The letter gave an account of those reasons. It stated that "... certain procedural rules governing criminal prosecution prohibit us from prosecuting many of the alleged false statements and other conduct of Drs. Gallo and Popovic, no matter what we might think of the relative merits of such a prosecution."

- Statute of limitations. After mentioning some of the "possible crimes" under consideration, such as making a false statement,

obstruction of justice or agency proceedings, and perjury, the letter invoked "the statute of limitations which bars prosecution for any such conduct which occurred prior to December 1988, which includes almost all the statements at the core of this case."

- Lack of jurisdiction. The letter stated that "several of the statements allegedly made by either Drs. Gallo and/or Popovic were made in the District of Columbia, and are therefore beyond our consideration for individual prosecution." Aside from that, the U.S. Attorney also recalled that "the U.S. Attorney's Office for the District of Columbia previously considered, and declined, prosecution" when the HHS Inspector General's office presented the case to them previously.

- Royalties on the patent for the blood test. Concerning the royalties, the letter stated: "Any such prosecution, such as for mail fraud ... or conspiracy to defraud the government ... would require the government to prove beyond a reasonable doubt that Drs. Gallo and Popovic knowingly and willfully devised a scheme to defraud the government of its property by means of false statements and representations. However, when the patent relating to the AIDS test was applied for in 1984, neither Drs. Gallo nor Popovic were entitled to share in the royalties for the discovery, nor could they have known at the time that the Technology Transfer Act of 1986 would authorize such payments ... we have also considered the investigation and report of the patent firm of Allegretti and Witcoff, which independently conclude that Dr. Gallo's statements in connection with the patent dispute were not 'prima facie' false, but rather subject to varying interpretations. Moreover, even the Office of Research Integrity acknowledged that any allegedly false statements were 'minor'; and did not invalidate the underlying research. Thus we do not believe we would be able to sustain our burden of proof to demonstrate several important elements of any federal offenses relating to the receipt of royalty payments."

- "Reasonable doubt." After noting the above obstacles to prosecution, the U.S. Attorney's letter also stated that the U.S. Attorney "was not satisfied that there is a substantial likelihood of convincing a jury beyond a reasonable doubt that either Dr. Gallo or Dr. Popovic acted with the requisite criminal intent."

- The Appeals Board decision and ORl's dropping the Gallo case vis-à-vis the Appeals Board. Finally, the U.S. Attorney's letter brought up the fact that in facing the Appeals Board, the ORI "was unable to meet a far lesser standard of proof, that of preponderance of evidence or 51% in its effort to convince the Board that Dr. Popovic's conduct involved intentional false statements."

The letter stated explicitly that the U.S. Attorney "could not ignore the conclusion reached by those independent arbiters" concerning the Popovic case, and also could not ignore "the decision of the ORI to forego even the presentation of evidence regarding the alleged misconduct of Dr. Gallo, some of which was independent of the actions of his subordinate Dr. Popovic."

However, the U.S. Attorney's letter did not stop with such legalistic considerations. It brought up two other kinds of issues.

(b) HHS responsibility in regards to the royalty payments. The letter stated: "Our decision not to seek prosecution of Ors. Gallo or Popovic does not mean that we believe they should continue to receive their annual royalty payments. On this issue, we express no opinion other than to observe that Dr. Gallo, as of approximately May 1991, has acknowledged that it was the French Institute Pasteur sample sent to his laboratory which formed the basis for the AIDS test. Whether he and Dr. Popovic should continue to receive their royalties under such circumstances, or whether the government should make any effort to recoup any payments made to them since then, are matters which are more appropriately addressed by the Department of Health and Human Services."

(c) General considerations of responsibility. The final part of the prosecutors' letter to the HHS Inspector General addressed general considerations of responsibility. I quote the last paragraph fully. "In deciding not to seek prosecution, we recognize that this case transcends the normal type of criminal case, and that the conduct of these two noted scientists reflects upon the integrity of the scientific process, the National Cancer Institute, and indeed the conduct of our government as a whole. However compelling is the need to provide a forum for historical accuracy on these issues, that noble desire cannot be a substitute for evidence, nor does it justify using the criminal courts in place of the court of public opinion."

Thus the letter from the U.S. Attorney to the HHS Inspector General in its last two sections threw back the Gallo case party to HHS and party to the scientific community.

In addition, an article by John Crewdson in the Chicago Tribune (see below) reported that, "Officials close to the case said the evidence gathered by the Inspector General, including thousands of pages of documents and interviews with some two dozen witnesses, would now be provided to the House Subcommittee on Oversight and Investigations, which is also investigating the case .... "

Thus the Gallo case was also thrown back to the Dingell Subcommittee.

§2. Press Reports

The letter from the U.S. Attorney to the HHS Inspector General was not reported in the New York Times. It was reported in the informative Crewdson article "U.S. declines to prosecute AIDS researcher Gallo" (Chicago Tribune, 21 January 1994, p. 1). Crewdson's article was approximately 3,800 words long, and provided extensive quotes from the letter, and mentioned its multiple points. Some accounts of this letter were also given in Science ("Feds Drop Gallo Criminal Probe," ScienceScope, 28 January 1994 p. 459), and Science and Government Report ("Saint or Scoundrel? The Gallo Controversy Goes On," 1 February 1994, p. 6). As a result, two things happened:

- On 1 February 1994, I wrote to the HHS Inspector General's office to get a copy of the letter from the U.S. Attorney, under the Freedom of Information Act. On 6 April 1994, I received a reply that this item (and others I had asked for) "which are part of an open and ongoing investigation are exempt from mandatory disclosure under the FOIA [Freedom of Information Act] by exemption (b)(7)(A)."

- On 14 March 1994, I wrote to Science editor Ellis Rubinstein to ask him for a copy of the above letter, because we had corresponded about this letter, and he had sent me some quotes from it, without sending me the entire letter. On exactly the same day that I received the notice from HHS that they could not disclose the letter, I received a copy of the letter from Ellis Rubinstein.

These two simultaneous events document the extent to which we live in a Kafkaesque world.

The ScienceScope piece "Feds Drop Gallo Criminal Probe" (Science, 263, 28 January 1994, p. 459) was approximately 300 words long, and reported the refusal of the U.S. Attorney to prosecute. It stated unambiguously: "Rather than exonerate Gallo, however, the prosecutors pegged their decision to legal hurdles." This piece mentioned briefly some of the reasons the U.S. Attorney gave for the refusal to prosecute, and the next to last paragraph of the ScienceScope piece was: "Contacted by Science, Gallo said he was 'frustrated' that the prosecutors said they halted the probe due to technicalities rather than a lack of evidence of wrongdoing. 'My reputation is everything,' he says. 'I still have no public forum to clear my name.'"

Nowhere in that piece did Science even allude to the fact that portions of the U.S. Attorney's letter to the HHS Inspector General dealt with the broader issue of responsibilities, as mentioned in §l(b) and §l(c). The reporting by Science was selective in the following manner:

- Readers could not learn from Science that the prosecutors had expressed concern with more than "legal hurdles" and "technicalities."

- Science brought to the fore Gallo's complaint about a lack of "forum" to clear his name, while at the same time Science did not mention the "forum for historical accuracy" and the "forum of public opinion" brought up by the prosecutors.

- Science did not mention the existence of passages in the U.S. Attorney's letter noting that Gallo acknowledged three years ago that the virus which he and Popovic used to develop the blood test was the French virus. In particular, there is no mention of any sentence such as the one stating: "Whether [Gallo] and Dr. Popovic should continue to receive their royalties under such circumstances, or whether the government should make any effort to recoup any payment made to them since then, are matters which are more appropriately addressed by the Department of Health and Human Services."

- Science did not give the information that the U.S. Attorney's letter stated: "In deciding not to seek prosecution, we recognize that this case transcends the normal type of criminal case, and that the conduct of these two noted scientists reflects upon the integrity of the scientific process, the National Cancer Institute, and indeed the conduct of our government as a whole."

The last paragraph of the ScienceScope piece, coming immediately after the Gallo quote about the lack of a "public forum to clear" his name, stated: "One ordeal remains for Gallo: Representative John Dingell (D.-Mich.) is expected to release a report on the Gallo case in May." This paragraph represented a specific point of view at the expense of others. Indeed, a question which may arise for some scientists (including me) is not whether "one ordeal remains for Gallo," but whether there will finally be made public documentation about the HIV blood test patent application and the behavior of the U.S. Government in this connection. There is also the issue of NIH withholding information over several years, and NIH stonewalling Dingell's request for information and documents pertaining to the patent application and what went on in Gallo's laboratory.

To me certainly, whether the truth about these events is an "ordeal" for Gallo is a secondary matter.

Furthermore, Science did not report, as Crewdson did in the Chicago Tribune, that the HHS's Office of the Inspector General would provide thousands of pages of documents and interviews to the House Subcommittee on Oversight and Investigation. Therefore Science did not provide relevant information, and reported the "expected" release of Dingell's Report in a manner which slanted the issues concerning the integrity of NIH and the government.

Readers are affected differently, according as Science reports issues one way or another. Scientists' reactions and the way they exercise their responsibilities are also affected very differently depending on whether they are, or are not, informed of the broader concerns of the U.S. Attorney.

§3. Some of My Conclusions

The engagement of the HHS Inspector General in a "criminal investigation" rather than in the dissemination of accurate information (establishing a "forum for historical accuracy"), so that the "court of public opinion" could operate in an informed way, had major consequences. At the very least:

(a) Much information was withheld, certainly from the public and especially from scientists outside the government, but also possibly from OSI and ORI themselves. For instance, did OSI and ORI have available the "thousands of pages of documents and interviews with some two dozen witnesses" when they were doing their own investigations? The supposedly non-legal offices OSI and ORI of HHS did not consider the matter of the patent application because originally the HHS Inspector General's office thought it involved questions which might give rise to prosecution, so there arose a Catch-22 situation, one of whose effects was to prevent some information from reaching scientists, let alone the public. Questions which OSI and ORI claimed could not be settled on the basis of evidence which they had available might have been settled if they had the evidence gathered by the Inspector General, but kept from them for legal reasons.

As a result of a legalistic approach, official and clear answers were not provided to a number of specific questions which had been raised about the patent application. It was, and still is, the responsibility of HHS, of the scientific community (especially of the Richards Panel), and of Dingell's Subcommittee to provide documented answers.

(b) The U.S. Attorney's decision not to prosecute provided an internal contradiction in the attempts by various segments of the government to shed light on the events of the Gallo case. As far as I am concerned, this decision showed in a spectacular way the bankruptcy of some attempts to resolve certain questions of scientific responsibility via the legal system. I repeat here the warning of Paul Doty, already quoted in connection with the Baltimore case (Nature, 18 July 1991, p. 183):

How would HHS, NIH, the scientific community, and the Dingell Subcommittee, meet their responsibilities from now on?

§4. The IG's Memorandum

Even though the prosecution requested by the Inspector General's office did not take place, the IG issued a 35-page memorandum which surfaced in some of the press, for instance:

As far as I was able to determine, the IG's memorandum was not covered by the New York Times.

It was only mentioned incidentally in the New York Times' article on the patent revision (see XVI, §3).

The IG's memorandum was very negative toward Gallo. It deals mostly with the patent application, although it also recalls false statements made by Gallo throughout the eighties. I shall quote one example from the memorandum dealing with the patent application, since we have not discussed the patent application so extensively elsewhere.

Gallo's lawyer Joseph Onek, on behalf of Gallo, wrote a letter to the Inspector General June Gibbs Brown on 23 June 1994, stating:

There followed 12 items. Onek also wrote that the memorandum was a "disgrace" and "should be withdrawn immediately."

I shall give here an example of a false statement by Onek to allow readers to form a more informed opinion. I find this example the easiest to understand of many such examples, because it requires no knowledge whatsoever of the Gallo case and its history. The matter has to do directly with an item that is in the IG's memorandum, and the fiat assertion by Onek that this item is not there. Who is making "errors" and "factual distortions"?

Therefore Onek's statement is false, in a particularly striking and obvious way. I shall give more similar examples in XVI, 94.

The false statement by Onek is especially grave, because Onek questioned the motivation of the Inspector General by commenting: "The failure of the OIG to mention these accidental contamination's demonstrates its total bias and its unrelenting effort to disparage Dr. Gallo's contention that the similarity in HIV-Lai and III-B is best explained by an accidental contamination in both laboratories." So what does Onek's false statement "demonstrate"? To whom?

As a scientist, Gallo is responsible for the lawyer's statements issued on his behalf, and for correcting these false statements. To my knowledge, he has not done so. Conversely, the scientific community is entitled to hold Gallo responsible for the statements made by his lawyer on his behalf.

Onek also objected that the IG's memorandum "never mentions that, as the Office of Scientific Integrity made clear, Dr. Gallo's laboratory had another isolate, HIV-RF, which could have been used for the AIDS blood test.

(Indeed, Dr. Popovic recommended that it be so used.) The existence of RF removes any motive for Dr. Popovic or Dr. Gallo to misappropriate the French virus and strongly supports the contention that the similarity of III-B and HIV-Lai is the result of an accidental contamination."

(a) We have already dealt in detail with the point about the isolate RF in our discussion of the OSI Report (V, §3). Gallo's lawyer actually was continuing a line first promoted in William Raub's press conference of 5 October 1990, that the existence of certain "isolates" in Gallo's laboratory were somehow exculpatory, or showed that Gallo had no motivation to appropriate the French virus. (Cf. the discussion in III.)

(b) The second half of the sentence, concerning an "accidental contamination," again contains an unjustified innuendo. Of course, the sample of what was thought at the time to be LAV-Bru was contaminated by LAV-Lai at the Pasteur Institute, as stated in the IG's memorandum. However, the point made in the IG's memorandum (and made by others throughout the case) is that Gallo used the French virus for his blood test, whatever patient this virus came from (Bru or Lai). For purposes of determining whether Gallo used the French virus, it is irrelevant whether this virus came from one patient or the other.

The rest of Onek's points can be analyzed similarly in light of the documentation, and thus can be shown to be without merit at best, or outright false. Having worked out several examples, I leave others as exercises for the reader. Of course, by issuing false statements and misrepresentations via his lawyer, Gallo succeeded in accumulating complications which caused more and more exchanges, and made it increasingly difficult for people without the appropriate background or stamina to determine the truth.

As usual, I am especially interested in the way exchanges such as the one between the IG and Onek-Gallo are handled in the scientific press. The article by Jon Cohen in Science reporting on the IG's Report started: "The latest headline grabbing investigatory report in the case of Robert Gallo and the discovery of the AIDS virus reads like a brief for the prosecution in a scientific fraud case against the National Cancer Institute researcher." I would describe the IG's Report as a carefully and meticulously documented account of Gallo's misrepresentations over the years.

Jon Cohen quoted uncritically the sentence from Onek to the effect that the IG's memorandum "is filled with an extraordinary number of errors, reflecting deliberate factual distortions, scientific illiteracy and obvious bias." Cohen also quoted Onek's

statement that the memorandum was a "disgrace" and "should be withdrawn immediately." Cohen made a special point of systematically and uncritically contrasting assertions from the IG's Report with objections raised by Gallo's lawyer Joseph Onek, in the letter to the Inspector General. He did mention that Onek did not address the statement I reproduced from the patent examiner, but otherwise he uncritically repeated Onek's objections.

In particular, Science did not inform its readers of the existence of false statements such as the one I have reproduced above or of the other example I shall give in XVI, §4. Thus Science misinformed its readers by a defective analysis of what Onek wrote. Readers for the most part do not have original documents in hand, and even if they do, they may not have the time or inclination to follow up the merits or demerits of various positions. For the most part, they may rely on Science to do the appropriate processing of information and summarizing for them. The examples I have given may help the reader evaluate not only Onek's statements but the way Science analyzes news items. Caveat emptor.
 

XVI. DEVELOPMENTS FEBRUARY-JULY 1994

§1. "New" Evidence: The Myers Documents

Extract from a letter dated 23 February 1994 
From John Dingell to NIH Director Harold Varmus 
Available under the Freedom of Information Act

For over two years, the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce has pursued an investigation of the Institut Pasteur/American HIV blood test patent dispute and related matters, including the research of Dr. Robert C. Gallo and his associates at the National Cancer Institute's (NCI) Laboratory of Tumor Cell Biology (LTCB). Newly discovered documents raise additional concerns about Dr. Gallo's candor and forthrightness on these matters. These and related concerns were not addressed, much less resolved, by any of the recent HHS investigations because the documents were withheld from the investigators ....

As recently as mid-December 1993, the Subcommittee was still receiving documents that had been withheld for two years. Most recently, the Subcommittee learned of the existence of a cache of documents never provided to the Subcommittee, located in the NIH Freedom of Information Act (FOIA) office. (FOIA officials told Subcommittee staff that prior to January 1994, they were never informed of any of the Subcommittee's document requests.) Not only were these documents withheld from the Subcommittee, their existence was not disclosed to the NIH Office of Scientific Integrity (OSI), to the Office of Research Integrity (ORI), nor to the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) ....

The recently discovered documents are of great significance; they bear on the still-unresolved central issue of the entire case, i.e. the possible misappropriation of the Institut Pasteur (IP) virus, LAV. The documents principally comprise correspondence

between Dr. Gerald Myers, a leading HIV geneticist, and a number of NIH scientists and senior scientific administrators, including Drs. Robert Gallo, Anthony Fauci, and Samuel Broder ....

The subject of the correspondence is the genetic identity of LAV and "HTLV-IIIb'...

In brief, the Myers/NIH correspondence shows that: (a) as early as April 1987, Dr. Myers had concluded that Dr. Gallo's account of the origins of his prototype virus (i.e. the claim that IIIb was independent from LAV and the claim that IIIb was derived from blood pooled from several patients) constituted a "double fraud" and that this "fraud" had resulted in significant deleterious effects on progress in HIV research; (b) by April 1989, Dr. Gallo himself had finally decided to "throw in the towel," and admit publicly that his virus was derived from the IP virus; and (c) Dr. Gallo reneged on his commitment to make this public acknowledgment. The implications of these developments should be assessed in the context of Dr. Gallo's conduct and statements concerning the identity of the viruses over the years, as well as Dr. Gallo's failure to disclose this highly relevant information to OSI.

The contents of the Myers/NIH correspondence are summarized in a Subcommittee staff memorandum attached to this letter. The substance of the "Myers" documents (and their greatly belated submission to the Subcommittee, not to mention the fact that the documents were never provided to OSI, ORI, or the HHS OIG) are matters of considerable concern. The contents of these documents, particularly in light of the conclusions of the Richards Committee and many members of Dr. Healy's irregular secret committee, raise renewed concerns about Dr. Gallo's veracity and forthrightness on these matters.

The Subcommittee is interested in hearing your views on this matter and what actions you plan to take. You may want to ask selected members of the Richards Committee, or other independent scientists, to review this new information and to advise. Given the importance of these issues, we request a response by Wednesday, March 9, 1994 ....

[Dingell's letter was cc-ed to Dan Schaefer, Ranking Republican Member of the Subcommittee; Philip Lee, Assistant Secretary of HHS; Harriet Rabb, General Counsel of HHS; June Gibbs Brown, HHS IG; and Fred Richards.]

My comments: The Subcommittee staff memorandum mentioned by Dingell in his letter to Varmus is dated 15 February 1994. It is 7-1/2 pages long, and contains extensive quotes from the primary sources,

that is, letters from Myers and statements from Gallo, substantiating Dingell's summary statements in his letter to Varmus. Both Dingell's letter and the Subcommittee staff memorandum to Dingell are available under the Freedom of Information Act, together with other "Myers documents."

To give readers an idea of the context in which the Myers documents occurred, I quote one passage from a memorandum from Myers to Gallo available under the Freedom of Information Act. Most of this passage is also quoted by Dingell's staff in their memorandum to Dingell dated 15 February 1994.

§2. The Latest from Fred Richards

The release of the Myers documents by the Dingell Subcommittee had a very substantial effect on Fred Richards, and some effect on members of his panel.

Footnotes for page 544
¹ In fact, Crewdson's first article came out in November 1989.

Science and Government Report reported this latest evolution, because they accepted to have an interview with Dan Greenberg. Crewdson subsequently informed readers of the Chicago Tribune (19 June 1994) where he quoted Fred Richards' statement from SGR, but Science, Nature, and the New York Times did not so inform their readers.

Neither Science nor the New York "Times reported the evolution of Fred Richards or members of his panel. If you are surprised, come to the front of the class because you haven't been paying attention.

§3. Revision of the Patent Agreement

In February 1994, the Institut Pasteur pressed the Clinton administration, and the new NIH Director Harold Varmus, for an acknowledgment that the Americans (Gallo) had used the French virus for the HIV antibody blood test, and for a revision of the patent agreement. The communications from Pasteur's Director Maxine Schwartz to Varmus are available under the Freedom of Information Act. Partly under the threat of a renewed law suit by the Pasteur Institute, and partly under pressure from the HHS Inspector General's memorandum, a new agreement was reached, substantially increasing the share of royalties going to the Pasteur Institute. The new agreement was covered in the press, for instance:

As late as 8 June 1994 Varmus had replied to Maxime Schwartz that "the acknowledgment of the role of the Institut Pasteur in isolating the AIDS-causing virus was very slow to occur, causing much frustrating litigation and other unproductive activity," but nevertheless Varmus was adamant that the previous agreement would not be modified. However, when the IG's Report came out a couple of days later on 10 June, Varmus changed his tune and the new agreement was reached. The abrupt change is noted both in the Chicago Tribune and the Science article, in complementary ways, which are instructive to understand how the higher-ups function:

According to Crewdson: "Asked Monday whether the Inspector General's inquiry, details of which first were reported last month in the Tribune, had played any role in the reversal of the U.S. position on the royalty issue, Varmus appeared to hesitate before replying, "Very little." Sources said a more probable explanation for the shift was the lawsuit Pasteur was prepared to file had negotiations failed. The suit claims that HHS concealed evidence from, and made false representations to, the French that induced them to settle the case in 1987. In an impassioned letter to Varmus last month, Schwartz declared bluntly that 'a cover-up of the true facts was deliberately undertaken so that we would settle.'"

According to Science, I July 1994, p. 25: "Varmus formally replied to Schwartz on 8 June. In his 'considered judgment,' the NIH director wrote, the royalty arrangement should stand .... Then came the OIG's 10 June report. Two weeks later, Varmus wrote Schwartz a letter with a different tone..."

Subsequently, Varmus reinforced somewhat the role of the HHS Inspector General's Report on his own thinking, as reported in Science two weeks later:

According to Science, 15 July 1994, p. 313: "Varmus acknowledged, however, that a 10 June report of an official investigation into Gallo's lab by the HHS Inspector General, which was critical of Gallo (Science, 1 July, p. 23), 'had some catalytic role in my own thinking.'"

At the same time, Varmus explicitly stated that no "deliberate misconduct by the government" was found, and his disclaimer about "culpability" or "wrongdoing" by the government or Gallo was reported in the press articles mentioned above. In any case, the choice by Varmus on 1 July to minimize the effect of the HHS Inspector General's Report on himself ("very little") raises a fundamental objection: When the higher-ups themselves do not take seriously into account the information which comes officially from their own organization, or minimize the importance of this information, then something is fundamentally cockeyed. But that's the way "the system works," as the saying goes. And Varmus is very much part of "the system."

The Inspector General's memorandum is mentioned only incidentally with a few words in the New York Times article, and no direct connection is made between the appearance of this memorandum and the change of mind by Varmus to reconsider the patent agreement.

The New York Times provided no analysis of the IG's memorandum.

§4. Running Interference by Gallo's Attorney

In XV, §4, I have already given one example how to process information when I analyzed a significant false statement made by Gallo's attorney Onek in his letter to the HHS Inspector General (23 June 1994). I shall give below two more samples of juxtapositions which can be made to compare Onek's assertions with the record. Readers can obtain the whole Onek memorandum from Gallo directly at the LTCB. I urge readers to compare what Onek wrote with the ORI Offer of Proof and the HHS IG's Report, which contain documented factual assertions about the history of Gallo's behavior, as well as repeated lists of scientists willing to testify about Gallo's deviation from accepted standards. It is possible to make up similar juxtaposations with several other statements by Onek, a task which I leave as an exercise for the reader.

Running interference by the legal system. There is another issue here, transcending the question whether Onek's statements are compatible with documented reality. This is the issue of a scientist dealing with other scientists through the legal system. I object to Gallo interposing a lawyer between himself and the scientific community. As a scientist, Gallo is directly responsible to the scientific community, which is entitled to hold him directly accountable for what Onek writes on his behalf.

In fact, American officials have supported the claims. The patent agreements were revised at about the same time Onek wrote to the Inspector General. Furthermore, the Institut Pasteur was continuously threatening litigation. Readers can compare Onek's statement with the following:

- The HHS Inspector General's Report, p. 27, which we have already quoted in XVI, §4: "Gallo did not disclose to the United States Patent Office the Pasteur scientists' 'prior art,'" i.e., their extensive work with the virus, LAV, and the existence and use of the LAV antibody blood test. Further, Gallo did not disclose to the patent office any of the LTCB's own experimental work with LAV.

The relevance of the IP's [Institut Pasteur] work to that of Gallo et al. was affirmed by the PTO [Patent Office] examiner, when she became aware of it. The examiner advised the OIG [Office of the Inspector General] that, had she been aware of the IP prior art at the time she examined the blood test application of Gallo, she would have suspended prosecution of the Gallo application and declared an interference between the two applicants."

- The letter from NIH Director Harold Varmus to Maxime Schwarz, Director of Institut Pasteur, 8 June 1994. In this letter Varmus stated: "The acknowledgment of the role of the In-strut Pasteur in isolating the AIDS-causing virus was very slow to occur."

- The statement by Varmus when he announced the new patent agreement, 11 July 1994, that HHS and NIH "officially acknowledge" that Gallo's lab "used a virus provided to them by Institut Pasteur to invent the American HIV test kit."

- The report in the Chicago Tribune (12 July 1994, "U.S., France settle AIDS virus dispute," p. 1) that "Pasteur was prepared to file had negotiations failed. The suit claims that HHS concealed evidence from, and made false representations to, the French that induced them to settle the case in 1987."

As for Onek's allusion to the French officials who let French citizens be infected with AIDS, it is correct that French officials in the medical bureaucracy allowed an existing blood supply contaminated with HIV to be exhausted before applying the available blood test. Since Onek brought up the issue, it is relevant to recall here that these French officials were condemned to jail terms.

On the other hand, Gallo himself refused to communicate some scientific information to certain colleagues at NIH. This information concerned the cell lines in which he was growing HIV. For this we come to our second example.

EXAMPLE 2

After I circulated Suzanne Hadley's critique of the Nicholas Wade-New York Times article representing Gallo as a martyred saint, Onek wrote a memorandum on Suzanne Hadley's critique, and he wrote me a letter dated 17 June 1994, stating: "As the attached memorandum demonstrates, that critique is filled with errors and distortions. I trust you will now circulate my memo to your correspondents." I did circulate Onek's memorandum, but I also pointed to possible comparisons with the documented record. For example, Onek made the following statement:

Readers can compare Onek's assertion with the record, as documented in the ORI Offer of Proof. There, from pages 49 to 71 one sees continuously documented how Gallo obscured the cell line, refused to communicate it to some colleagues at NIH, and how he was ordered to do so by higher-ups at NIH. Several scientists are listed as willing to testify to Gallo's transgression of scientific standards, for instance, Martin, Schaffer, Curran, Richards, Tramont, Goldberger, Rall, Raub, Morgan, and McGinnis. I recall here a few of these references:

In the memorandum about Hadley's critique, Onek also repeated what he wrote to the HHS Inspector General about the French blood test scandal. We have already dealt with this item in Example 1. Suzanne Hadley herself replied in a letter to Onek dated 14 July 1994: "No amount of fingerpointing at Luc Montagnier, the French Government, or anyone else will alter the nature and consequences of Bob's statements and actions, or make them any more praiseworthy. Yes, the French did have a blood test scandal. They at least dealt with it; they at least put their miscreants in jail .... "

Suzanne Hadley concluded her letter to Onek with the statement: "The record is compelling. The truth--in its entirety, and at long last--will come out. It really will."

§5. Failures of Scientific Responsibilities

The entire Gallo affair provides evidence of the way the scientific community is unable to police itself.

- The NAS and IOM have systematically evaded responsibilities from beginning to end, culminating with the "convocation" on misconduct of 6-7 June 1994 (see my essay "Maintaining Standards"). I remind readers that Gallo was elected to the NAS in 1988.

- Strong forces in the government and in the scientific community obstructed the search for the truth in the Gallo affair. I list some items documenting obstructions following the nomination of the Richards Panel by the NAS and IOM at the request of HHS-NIH: The "reining in" (dismissal) of Suzanne Hadley by NIH Director Bernadine Healy, thus derailing the investigations; the subsequent manipulation and mistreatment of the Richards Panel by NIH, especially Healy; the withholding of documents

from the Richards Panel (e.g., the Myers analyses and the Roche analysis), from ORI, and from the Dingell Subcommittee; the panel's acceptance of this treatment without protesting publicly; the evasion of responsibility of the NAS and IOM toward the Richards Panel; the fact that we have to learn of the Richards conclusion from Science and Government Report, but do not get this information from NIH-HHS, the NAS, or Science (never mind Nature, which is a dead loss).

- In Spring 1994 Fred Richards concluded that "they stole the virus," but he said that "we didn't know that at the time these [investigative] reports came out." Actually, some scientists such as Don Francis had been saying that all along. One reason some other scientists did not know is that under Bernadine Healy, the Roche analysis was withheld by OSI from the Richards Panel at the time the OSI Report came out in 1992, and the Richards Panel did not investigate independently to find out what was being withheld from them. Also under Bernadine Healy, and continuing for months after she left, NIH stonewalled requests for documentation from the Dingell Subcommittee. Ultimately it was not the scientific community which uncovered the Myers documents, it was the staff of the Dingell Subcommittee; and we learned some of this information from Dan Greenberg and John Crewdson, not from Science or Nature.

- The Onek-Gallo replies to scientific governmental evaluations, and the aborting of the ORI and HHS Inspector General's investigations by the legal system, show how lawyers are pushing the scientific community to adopt legalistic thinking, which is on the way to replace the exercise of scientific responsibility. The main criterion for acceptable behavior is quickly becoming that if what one does is not demonstrably illegal (and, in particular, criminal intent cannot be proved), then it's OK. NIH Director Varmus and the Secretary of HHS have so far done nothing official about the reports of ORI and the HHS IG, and Gallo was still Chief of LTCB in Fall 1994.

- In the ORI Offer of Proof, one sees repeatedly that a couple of dozens of scientists were willing to testify about Gallo's multiple transgressions of scientific standards, including Don Francis, Montagnier, Barre-Sinoussi, Martin, Curran, Cabradilla, Goldberger, Rall, Morgan, Raub, Huth, Richards, and other members of the Richards Panel, Schaffer, Tramont, Woolf, McGrath, Hadley, etc. But we have to get the Offer of Proof individually under the Freedom of Information Act to get this information. We did not get this information from the NAS, from Science, or from official reports of the Richards Panel. Why should scientists cooperate

- The documentation is massive, and some (many? most?) individual scientists may consider that they have other things to do besides processing the information contained in the documents arising from the case. On the other hand, the standard journals don't provide the information properly (Science, Nature, etc.).

- The abdication of responsibility by the higher-ups in the science establishment (NAS, IOM, NIH, HHS, and the scientific journals such as Science and Nature) make it very clear that individuals who attempt to maintain standards are isolated, or disregarded, or obstructed by the scientific establishment. This is the lesson derived from the Gallo case for those scientists who would be willing to detract from time possibly spent on research, to get engaged in a battle for standards.