Correspondence∙Documents in the Gallo Case

By Peter M. Stockton¹, Suzanne W. Hadley² et al.
¹Former investigator on the Subcommittee on Oversight and Investigations
²Ph.D., formerly OSI Deputy Director and chief investigator of the NIH Gallo investigation)

Correspondence

Here is what the former Chairman of the Subcommittee, John Dingell, had to say to Harold Varmus, Director of the NIH, about the report. On 23 January 1995, Ned and I wrote a letter to Kenneth Ryan (head of the Ryan commission) and a letter to Harold Varmus, Director of the National Institutes of Health. These letters are mentioned prominently in John Dingell's letter of 3 February 1995 to Harold Varmus. -------------------------------------------------------- February 3, 1995 The Honorable Harold E. Varmus Director National Institutes of Health One Center Drive, MSC 0148 Bethesda, Maryland 20892-0148 Dear Dr. Varmus: I have received a copy of a January 23, 1995 memorandum to you from Mr. Walter Stewart and Dr. Ned Feder, as well as their letter to Dr. Kenneth J. Ryan. They have enclosed a "draft report" that they claim was authored by staff of the Subcommittee on Oversight and Investigations. We cannot vouch for the authenticity or accuracy of the papers provided to you. They were not reviewed, much less evaluated, by the staff director, the Chairman, or any other Member of the Subcommittee. While some staff time was spent developing a report, one early draft of the matter had been rejected by the Subcommittee staff director several months ago. Because of the election results and the resultant time and resource constraints imposed by the transition, and the enormity of the editing and fact-checking tasks needed to assure that a report on this topic met the standards of the Subcommittee, no report was issued. Drafts and relevant files on this inquiry were turned over to the incoming majority as a pending and uncompleted matter. I hope that this information will be of use to you as you and others assess the "draft report" and respond to the requests made by Mr. Stewart and Dr. Feder. Sincerely, JOHN D. DINGELL cc: Dr. Kenneth Ryan -------------------------------------------------------- Congressman John Dingell Congressman John Dingell has done wonderful work in focusing public attention on the problems of scientific misconduct and in encouraging the scientific community to assume responsibility for these problems. Neither he nor his office is yet reachable on the internet. You can reach his office at the following phone numbers: 202-225-4071 Washington office; 313-846-1276 Michigan office. You can snail-mail him at the following address: The Honorable Congressman John Dingell 2328 Rayburn House Office Building Washington, DC 20515 ---------------------------------------------------- 23 January 1995 Dr. Harold Varmus, Director National Institutes of Health Dear Dr. Varmus: We enclose here a draft report on an investigation of the Gallo case by the staff of a subcommittee headed by Congressman John Dingell. We also enclose our letter to Dr. Kenneth J. Ryan. The draft report raises serious questions about possible misconduct in a particular case and about the proper conduct of science generally. We are referring to misconduct not in the quasi-legal sense used by ORI, but rather misconduct as it is understood by practicing scientists -- as practices that are professionally unacceptable. We believe that there issues of conduct and misconduct in science are best addressed through the free and open debate -- a process that has long been traditional in science and is an essential part of self-regulation in science. The NIH's continuing imposition of a gag order on our speech is unfortunately not consistent with this tradition. We have suggested that the Ryan Commission take a leading role in contributing to and encouraging public discussion of the Gallo case and other serious issues. In addition to this traditional process of discussion and self-regulation by scientists themselves, it appears that certain administrative steps should be considered for the case discussed in the enclosed draft report. We therefore request that you bring the enclosed report to the attention of the appropriate authorities. Sincerely, Walter W. Stewart, OPPE, NIDDK, NIH Ned Feder, RB, DEA, NIDDK, NIH Enclosures: Letter of 23 January 1995, Feder and Stewart to Ryan, plus enclosures cc: Mr. Thomas Devine, member of Commission on Research Integrity; Legal Director, Government Accountability Project Mr. L. Earl Laurence, Acting Deputy Director and Executive Officer, NIDDK, NIH ------------------------------------------------------------------- 23 January 1995 Dr. Kenneth J. Ryan Chairman, Commission on Research Integrity Brigham and Women's Hospital 75 Francis Street Boston, MA 02115 Dear Dr. Ryan: We are enclosing a document that we believe will be of interest to you and the other members of the Commission. It is a draft report on an investigation of the Robert Gallo case by the staff of the Subcommittee on Oversight and Investigations headed at the time by Congressman John Dingell. The draft report, though not officially released by the Subcommittee, has recently been discussed and quoted in an article in the Chicago Tribune. Although parts of the draft report have been made public, much of it has not been available for examination and discussion by scientists and laymen. The Gallo case, more clearly than any other of which we are aware, reveals the way that academic, scientific, and government institutions mishandle allegations of misconduct committed by senior scientists. The case is additionally important because of its implications for public health. The draft report presents evidence indicating: That the misconduct was unusually broad in its scope, with repeated, substantial, public misrepresentations made by Dr. Gallo and his colleagues over a period of several years, in scientific journals, in sworn statements, and in other forums, That initially the claims made by Dr. Gallo created a false picture that enhanced his professional reputation, and that these claims later yielded him substantial patent royalties, That Dr. Gallo's actions set back AIDS research in other laboratories around the world. These points alone make the staff report on the Gallo case highly relevant to the work of the Commission. But the response of institutional authorities to the allegations of misconduct, as described in the draft report, should be a matter of special concern to the Commission. The draft report presents specific, detailed evidence that indicates a serious malfunction of the institutional mechanisms for dealing with alleged scientific misconduct. The draft report draws these conclusions (Executive Summary, here): One of the most remarkable and regrettable aspects of the institutional response to the defense of Gallo et al. is how readily public service and science apparently were subverted into defending the indefensible.... The deliberately negligent "fact-finding" conducted by these individuals [scientific administrators of NCI and DHHS], combined with their deliberate suppression of incriminating evidence, set the stage for everything that happened thereafter.... The result was a costly, prolonged defense of the indefensible.... The consequences for HIV research were severely damaging, leading, in part, to a corpus of scientific papers polluted with systematic exaggerations and outright falsehood of unprecedented proportions. Dr. Gallo's rebuttals, defenses, and other statements over the past decade are quoted throughout the report. The Commission faces a difficult task in framing recommendations that will curb such problems in the future. A primary goal should be an atmosphere in which specific instances of alleged scientific misconduct are freely and openly discussed -- without fear of reprisal. The facts given in the draft report strongly suggest that there is a long way to go before we reach that point. As part of its efforts to improve the atmosphere in which science is conducted, the Commission could conduct a thorough examination and discussion of the facts in the Gallo case. The Commission could review, in particular, the inadequate institutional response to allegations of misconduct in this case and submit recommendations that will make the recurrence of such events less likely. Sincerely, Walter W. Stewart, OPPE, NIDDK, NIH Ned Feder, RB, DEA, NIDDK, NIH Enclosures: Draft Staff Report, Subcommittee on Oversight and Investigation, Committee on Energy and Commerce, U.S. House of Representatives, 267 pages plus table of contents Executive Summary for draft Staff Report, 65 pages plus table of contents Article in Chicago Tribune, "In Gallo case, truth termed a casualty," by John Crewdson, January 1, 1995 Editorial in Chicago Tribune, "Defending the indefensible Dr. Gallo," January 6, 1995 Article in The Cancer Letter, "Pursuit of Truth Was Not An NIH Objective In Gallo Case, Dingell Staff Report Says," January 6, 1995 cc: Mr. Thomas Devine, member of Commission on Research Integrity; Legal Director, Government Accountability Project Dr. Harold Varmus, Director, National Institutes of Health Mr. L. Earl Laurence, Acting Deputy Director and Executive Officer, NIDDK, NIH --------------------------------------------------- The draft report and accompanying materials are made available here to the scientific community in response to the urgings of a number of senior scientists (see, for example, the letter of John Edsall, the letter of Charles Park, and the letter of Elliot Lieb, all written to Congressman Dingell). -------------------------------------------------- 7 Divinity Avenue, Harvard University Cambridge MA 02138-2092 Feb. 4, 1994 The Honorable John D. Dingell, Chairman Subcommittee on Oversight and Investigations Committee on Energy and Commerce House of Representatives Dear Representative Dingell, As a biochemist who is deeply concerned with maintenance of standards of integrity in scientific work, I have followed the controversy over the discovery and identification of the virus of AIDS, with particular reference to the role of Dr. Robert Gallo. It does seem clear that the virus on which Dr. Gallo worked, which has served as the basis for development of the HIV antibody blood test, was in fact discovered in Paris at the Institut Pasteur. However it was the U. S. Government that was awarded the patent on the blood test, and later our government obtained other patents also. Yet grave questions remain, concerning the allocation of the patents, and what appears, to a great many scientists and others, as a violation of the rights of the French investigators and the French Government. Apart from this very serious matter, other important questions have been raised about Dr. Gallo's alleged misconduct. All these problems, and more, are apparent in your opening statement for the Subcommittee hearing of Dr. Harmison on July 21, 1993. Yet the subsequent course of events at the Office of Research Integrity (ORI) and the Review Panel that oversees ORI cases, seems to point to a complete exoneration of Dr. Gallo. Indeed, after the Review Panel had earlier rejected the charges brought by the ORI in the case of Dr. Popovic, and cleared him completely of wrongdoing, the ORI decided not to press its charges against Dr. Gallo, and thus he has been completely cleared of the charges in that case. I base this conclusion on the recent report in Science, 7 January 1994, pp 20-22. However, although the Review Panel, which up to now has been composed entirely of lawyers, has in effect brought about the clearance of Gallo from the legal charges in this case, I believe that the standards of ethical conduct for scientists are, and should be, more demanding than the purely legal rules. They must be so, if the public is to retain its confidence in the scientific community. In fact, looking at the history of the Gallo investigation, I see a pattern of evasion, and suppression of information, at several points along the line. One example is the effective suppression by Dr. Bernadine Healy, when she was Director of NIH, of the report of the panel headed by Dr. Frederic M. Richards. This panel had been set up by the National Academy of Sciences, at the request of a previous acting director of NIH, to oversee the investigation conducted within NIH itself, and to give assurance to the public that it would be a rigorous and searching inquiry. However, in practice, the situation developed quite differently. Dr. Healy effectively blocked the public release of the report of the Richards panel, which was known to be much more critical of Gallo's conduct than the internal NIH report. It was the latter that was released to the public; the full text of the Richards panel report has not yet been seen by the public. Dr. Healy herself may have been under pressure from other high officials to suppress the report of the Richards panel, but of course I have no evidence for this. The Inspector General of HHS, after two years of investigation, recently asked Federal prosecutors to initiate a prosecution against Gallo, concerning his conduct in obtaining the patents on the HIV antibody blood test. However, as described in a recent article by John Crewdson in the Chicago Tribune (Jan. 21,1994), the Federal prosecutors decided, for various reasons, not to press charges. In a quite unusual statement for a prosecutor, however, they wrote: " Our decision not to seek prosecution of Drs. Gallo or Popovic does not mean that we believe they should continue to receive their annual royalty payments" from the AIDS test. In another place they noted that "....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." (I draw these quotations from Crewdson's report.) You are certainly well aware of all these problems, and you are clearly disturbed by them, as your opening statement of last July in the Harmison inquiry clearly indicates. It appears, however, that the attempt to clear Dr. Gallo of all legal charges against him is on the verge of complete success. If you have strong evidence that could lead to a different conclusions would not this be the time to make it public, in the interest of truth and honesty, and perhaps also of appropriate legal action? Yours respectfully John T. Edsall Professor of Biochemistry Emeritus ------------------------------------------------ 7 February 1994 Representative John Dingell Subcommittee on Oversight and Investigation 2323 Rayburn House Office Building Washington, DC 20515 Dear Mr. Dingell, You are to be congratulated for your continued pursuit of the truth in the Gallo case. What you have done and hopefully continue to do is very important and is much appreciated by the scientific community. I understand that your Subcommittee on Oversight and Investigation has collected information on the Gallo case that has not previously been made public. I hope the Committee will make a full disclosure of this material. Sincerely yours, Charles R. Park, M.D. Professor Emeritus of Physiology Member, U.S. National Academy of Sciences CRP:cp -------------------------------- January 23, 1994 Representative John Dingell Subcommittee on Oversight and Investigation 2323 Rayburn House Office Building Washington, DC 20515 Dear Mr. Dingell, I am writing to urge, in the strongest possible terms, that your committee issue a full report on the Gallo case. It is clear that this case and its importance did not die with the Appeals Board ruling. It is also clear that the public, and especially the scientific community, needs to know everything that your committee found, despite the obstructions placed in your way. We need this information if we are to maintain high ethical levels in science and the administration of science Sincerely yours, Elliott Lieb Jones professor of Mathematical Physics Member, U.S. National Academy of Sciences --------------------------------------------------------- On 4 February 1995, Robert Gallo phoned Ned Feder and had an extensive discussion with him and, later in the day, with Walter Stewart. He said that he had only very recently received the draft Staff Report and that he had not yet read it. He said that he thought that of available documents, those that best pointed out the deficiencies of the draft Staff Report were Bernadine Healy's letter of 19 January 1995 to the Chicago Tribune and Joseph Onek's letter of 3 February 1995 to The Cancer Letter. He urged us to obtain and read these letters. We said that we would, and that we would make them available on the Web (which we did the next day). ------------------------------------------------- The following letter appeared in the 19 January 1995 issue of The Chicago Tribune. No conspiracy in HIV controversy CLEVELAND -- In his final spasm as outgoing chairman of the Energy and Commerce Committee, Rep. John Dingell (D. Mich.) heaved another package of fabrications and distortions. These latest accusations arrived in an allegedly unauthorized, "leaked," secret draft report on a three-year investigation of a controversy surrounding the 1984 discovery of the AIDS virus (HIV) reported by the Tribune. 1. One hopes this marks the end of Dingell's deluded notions of a multi-administration conspiracy to protect Dr. Robert Gallo, one of the discoverers of HIV who also developed the blood test for HIV. At enormous taxpayer expense, Dingell has pursued Gallo and attacked anyone who has refused to join in his crusade. The former chairman first accuses me, as then-director of the National Institutes of Health, of "replacing" an employee of the NIH's Office of Scientific Integrity (OSI) who wrote a report that was "sharply critical of Dr. Gallo." This employee was never replaced. On the contrary, before I arrived at the NIH, she requested and was given a new job in an unrelated department. She was also given leave at that time to complete her work on the Gallo case. I did ask her to revise the amateurish and poorly written report for style and structure, but when she complained that revision would change the meaning, I withdrew my request immediately. I subsequently accepted the employee's report which ironically, though critical of some of his actions, had always exonerated Dr. Gallo of misconduct. Second, the former chairman contends that I "bypassed" the "conclusions" of an advisory committee in accepting the OSI report that exonerated Dr. Gallo. In fact, I was presented with several non-binding recommendations of advisory groups, all of which advised acceptance of the report except one. The one contrary recommendation came from a committee that refused to consider evidence or testimony from the accused. I easily could have ignored all other findings in favor of the advice from the one flawed advisory committee. Instead, I made an independent judgment that, after careful review, seemed to me to be correct. My unwillingness to be a pawn in the former chairman's smear campaign prompted further false accusations. An example is the third charge in his report, his invention of a conversation in which I told him that I felt I had to "save Bob [Gallo]." I never made such a preposterous statement. As the head of an agency that was a frequent target of Dingell's witch-hunts, I saw first-hand the abuse of power by a long-time committee chairman and his staff acting as secret police, prosecutor, judge and jury under the old House rules. Americans would be shocked to learn of the clandestine tape recordings, document theft, threats, foul-mouthed verbal rantings and abusive closed-chamber interrogations of the former chairman and his staff of over 100. Immune from the Freedom of Information Act and the laws against libel and slander, Dingell and his staff operated in virtual secrecy, withholding any documents that displayed its methods of operation or contradicted its fabricated story lines. This gave them carte blanche to make reckless and unsupported statements about people or institutions. Let the actions of Dingell and his bloated staff be a memorial to what went wrong with Congress after 40 years of single-party rule. Bernadine Healy Staff, Cleveland Clinic Foundation Former Director, National Institutes of Health ------------------------------------------------------- The following letter was submitted to the Chicago Tribune 2 February 1995. FOR PUBLICATION IN "VOICE OF THE PEOPLE" Dr. Bernadine Healy's January 19, 1995 letter concerning the "Dingell Subcommittee" draft staff report in the "Gallo" case, reported in the January 1 Tribune, was characteristically inconsistent with the facts. As former NIH and Subcommittee investigators in this case, we write to set the record straight about the most notorious (by no means all) of the questionable statements in Dr. Healy's letter. 1. Dr. Healy's orders for changes in the NIH "Gallo" report did not bear merely on the "style and structure" of the report. Independent memoranda to Dr. Healy from the then-Director of the NIH Office of Scientific Integrity (OSI) and the chief investigator (supported by the then-Deputy Director of NIH) protested that Dr. Healy's ordered changes, "would be damaging and enervating" and would "significantly vitiate the findings" of the Gallo report. 2. Contrary to Dr. Healy's claim, the NIH Gallo report did not "always exonerate[d] Dr. Gallo of misconduct." The penultimate version of the draft report found Dr. Gallo guilty of scientific misconduct, while the final version of that report found that Dr. Gallo "created and fostered conditions that gave rise to falsified/fabricated data and falsified scientific reports" and Dr. Gallo's actions "warrant significant censure." Based on these findings and other contemporaneous situations of wrongdoing in the Gallo laboratory, Dr. Healy's predecessor decided to initiate a formal evaluation of Dr. Gallo's fitness to serve as an NIH laboratory chief. These plans, of course, were preempted by Dr. Healy's arrival at NIH. 3. Dr. Healy did indeed replace the NIH chief investigator in the Gallo case, ordering that the investigator be "reigned in" and "make no further decisions" in the case. Moreover, Dr. Healy ordered an investigation of the chief investigator herself, an investigation that the then-OSI Director described in memoranda to NIH attorneys and Dr. Healy herself as "improper" and "a threatening intimidation." 4. The "flawed advisory committee" -- so characterized by Dr. Healy -- was in fact a panel of distinguished scientists nominated by the National Academy of Sciences to oversee the NIH investigation. Contrary to Dr. Healy's assertion, this committee examined extensive evidence submitted by Dr. Gallo and his associates. Also, contrary to Dr. Healy's assertion, the committee interviewed both Dr. Gallo and his close associate, Dr. Mikulas Popovic, both of them subjects of the NIH investigation. 5. Concerning her implication that partisan politics produced her stormy relationship with the Subcommittee, Dr. Healy seems to have forgotten just how bipartisan the Subcommittee was in its dealings with her. During the Subcommittee's August 1991 hearing into Dr. Healy's firing of the Gallo chief investigator, as well as Dr. Healy's mishandling of a misconduct investigation at her own Cleveland Clinic Foundation, Virginia Congressman Thomas J. Bliley (then the ranking Republican on the Subcommittee, now the new Chairman of the Committee on Commerce) observed that Dr. Healy's mishandling of the Cleveland Clinic investigations, "... raises questions about Dr. Healy's willingness to vigorously pursue allegations of scientific misconduct..." Rep. Norman Lent (then the ranking Republican on the Committee on Energy and Commerce) described Dr. Healy's actions in the Gallo case as "startling, perhaps even bizarre." In short, contrary to her mutterings about "single-party rule," Dr. Healy's adversarial relationship with the Subcommittee -- whose investigation of the Gallo matter was at all times remarkably bipartisan -- was entirely of her own making. Finally, it is astonishing that Dr. Healy describes as an "invention" the staff report's account of her statement to Chairman Dingell that she had to "save Bob." The staff report accurately describes what Dr. Healy said and did concerning these matters, in all particulars. Peter M. Stockton (former investigator on the Subcommittee on Oversight and Investigations) Suzanne W. Hadley, Ph.D. (formerly OSI Deputy Director and chief investigator of the NIH Gallo investigation; subsequently an investigator with the Subcommittee on Oversight and Investigations) ----------------------------------------------------- This letter appeared in the 3 February 1995 issue of The Cancer Letter. Gallo Attorney: Subcommittee Report Full of Errors, "Drivel" To the Editor: It would require a volume to respond fully to all the errors in the draft report on the AIDS blood test patent, as described in The Cancer Letter of Jan. 6. Here are just a few points your readers should consider. 1. The Institut Pasteur did file a patent application for an AIDS blood test several months prior to Dr. Gallo and his colleagues. The problem with the application is that it expressly stated that the test scored positive in only 20 percent of AIDS patients. In short, the test was essentially useless. 2. As a practical matter, there could be no AIDS blood test until the scientific community was convinced that a new retrovirus (now called HIV) was the cause of AIDS. It was Dr. Gallo and his colleagues who demonstrated the etiology of AIDS in four landmark papers published in Science in May 1984. Similarly, there could be no blood test until HIV isolates could be grown in significant quantity. It was Dr. Gallo's colleague, Dr. Popovic, who accomplished this breakthrough, as described in one of the four Science papers. Finally, there could be no blood test unless the test scored positive in most AIDS patients. Dr. Gallo and his colleagues described such a test in the Science papers. The information in the Science papers provided the basis for the Gallo blood test patent filed in April 1984. 3. Neither the Centers for Disease Control nor the Institut Pasteur had any credible results comparable to Dr. Gallo's at the time the Gallo blood test patent was filed. In fact, in May 1984, CDC and Pasteur scientists submitted a paper to Science (published July 1984) describing a test that scored positive in only 41 percent of AIDS patients. The article also stated that "it is possible" [last word italicized] that the French virus and the American virus were the same subtype. Thus, at the time the Gallo patent was filed, the Institut Pasteur did not have a comparable blood test and there was insufficient evidence to demonstrate that the French and American viruses were the same subtype. 4. Dr. Gallo and his colleagues did use the French virus HIV-Lai in their blood test. But this use was accidental in two senses. First, HIV-Lai accidentally contaminated the American isolate HTLV-IIIB just as it contaminated the isolate LAV-Bru in the Institut Pasteur and contaminated isolates in the laboratories of Dr. Robin Weiss and others. Second, Dr. Gallo's laboratory could have used a different isolate, RF, for the blood test. The draft report's suggestion that RF was not ready demonstrates a total ignorance of the facts. RF was growing well by early 1984, as laboratory records attest. Dr. Gallo's laboratory did not send out HTLV-IIIB for use in the blood test until April 1984. Dr. Gallo's laboratory clearly could have scaled up RF for use in the blood test by April if it had chosen to do so. 5. The draft report's claim that Dr. Gallo and his colleagues hid information is laughable. Even before the patent application was filed, Dr. Gallo went to Paris and arranged for the Institut Pasteur and his laboratory to prepare joint papers concerning the French and American viruses. These papers were prepared, but were not published at the request of the French. In May 1984, only three weeks after the patent application was filed, Dr. Gallo provided the Institut Pasteur with a sample of HTLV-IIIB to work with. Dr. Gallo and his colleagues then conducted most of the studies that led to the discovery of the close similarity between the French and American viruses and then to the discovery of the dual contamination. It was Dr. Gallo and his colleagues who first reported that the AIDS virus, unlike HTLV I and II, was heterogeneous. It was Dr. Gallo's laboratory that reported the sequence of the HTLV-IIIB isolate, thus making comparison to the French isolates possible. It was Dr. Gallo's laboratory that reported that HTLV-IIIB and the French isolate LAV-Bru were different. This led to the Institut Pasteur's belated discovery in 1991 that LAV-Bru had been contaminated by HIV-Lai in its laboratory in 1983. Finally, once the Institut Pasteur explained about the contamination that had occurred in its laboratory, Dr. Gallo promptly acknowledged that his laboratory had accidentally used HIV-Lai in its blood test. This acknowledgment was made in 1991, well before any studies by independent laboratories or Dr. Varmus' statement in 1994. It is bad enough that The Cancer Letter devoted so much space to such drivel. But its use of Dr. Suzanne Hadley as a commentator is truly extraordinary. Dr. Hadley's bias and incompetence are well known; every major scientific misconduct report she has worked on has been thrown out. Perhaps The Cancer Letter will now rely on tobacco executives to provide commentary on the causes of lung cancer. Joseph Onek Counsel for Dr. Robert Gallo Crowell & Moring -------------------------------------------------------- Editor's Note: The Cancer Letter decided that in light of Mr. Onek's comments about her, Dr. Hadley was owed the opportunity to respond. Her response follows: Hadley: OSI Underestimated Magnitude of Gallo Case To the Editor: Mr. Onek would do well to examine the facts in the Subcommittee staff report, rather than trotting out yet again the same irrelevancies and unsubstantiable claims that for years have characterized his and Dr. Gallo's responses concerning these matters. Mr. Onek's claim that the Gallo laboratory could have used the RF isolate for its HIV blood test is just one example of numerous Gallo/Onek claims that are compellingly disproved by the evidence detailed in the staff report. As for Mr. Onek's gratuitous, plainly silly comments concerning The Cancer Letter's choice of commentators, they hardly warrant a response. However, since Mr. Onek has raised the issue of the competence of Office of Scientific Integrity investigations, I gladly take the opportunity to acknowledge that OSI missed the boat in one major scientific misconduct case, i.e., the investigation of Dr. Gallo and his colleagues. As the former chief investigator in the case, I can say with certainty that no one at OSI comprehended the extent, seriousness, and systematic quality of the falsehoods that were perpetrated in this case. Nor, certainly, did we comprehend the significance of the official imprimatur that years earlier had been stamped on these falsehoods. In short, we had no idea what we were up against. The stakes became clear in the spring of 1991, when an OSI report that pointed out numerous false statements in the Gallo et al. patents and related US government pleadings was dismissed by NIH/HHS attorneys with the offhand comment that, "We don't think there's a problem here." Shortly after preparing this report, I was forced to resign as chief investigator in the Gallo case. Fortunately, thanks to Congressman John Dingell and the subcommittee, this was not the end of the matter. The full text of the subcommittee staff report is now available, on the World Wide Web at the following URL number: http://www.nyx.net/~wstewart/ The scientific community and the public finally can examine the evidence and make their own judgments about these important matters. They will find the staff report solid in all its findings. Suzanne Hadley Rockville, MD -------------------------------------------- Ned and I both urged Dr. Gallo to read the draft Staff Report and to document any deficiencies he found in it. We offered to make his response widely available and to disseminate it on the Web at this site and wherever else the draft report was available. We offered to convert his response to the proper format for the Web. He thanked me for my advice and said he would consider it carefully over the next few days. He stated that he had never had any quarrel or problems with either Ned or myself, and that he enjoyed talking with me. Ned and I subsequently reiterated our strong suggestion to Dr. Gallo that he respond to the draft staff report and our offer to disseminate it for him on the Web in a letter of 5 February 1995. We subsequently received from Dr. Gallo a letter of 18 February 1995 addressed to both of us. ------------------------------------------------------------------ 5 February 1995 Dr. Robert C. Gallo Building 37, Room 6A11 National Institutes of Health Bethesda, MD 20892 Dear Bob: We appreciated your phoning us yesterday to discuss our Web site and the draft staff report. We enjoyed talking with you and regret the personal difficulty that the discussion of these important issues is causing you. We understood from your statements that you think that of the available documents, the Healy letter of 19 January 1995 and the Onek letter of 3 February 1995 best point out what you feel are the deficiencies of the draft staff report. As you requested, we obtained those documents and read them carefully. We are making them available with the draft staff report on the World Wide Web, as we said we would do. We understood from you that you had received the draft staff report only three days ago, and that you had not yet read it. You stated that you found such reports on the case very stressful to read. We understand this and regret it. You appealed to us as NIH colleagues to see to it that your side of the story received attention. As we said, we consider it crucial that you read and respond to this draft report yourself. Responses from attorneys simply will not carry the same weight with scientists as a clear and completely documented response from you. We were pleased that you thanked one of us (WWS) for this advice and said that you would consider it carefully. You asked whether people would bother to read your reply. We feel strongly that they will. For our part, we will do our level best to disseminate unedited any reply that you make. You stated that you do not have the expertise to post your reply on the Web, and we said that we would be glad to do that for you. Just write a reply to the report, and we will ensure that your reply gets as much prominence as the draft staff report itself, at least at all the Web sites at which we have influence. To repeat: we will disseminate unedited any reply that you send us (and we will see to it that your reply is converted to the proper format for the Web). If there is anything else we can do to facilitate a reply from you, please let us know. Sincerely, Walter W. Stewart Ned Feder ----------------------------------------- February 18, 1995 Dr. Walter Stewart Laboratory of Chemical Physics Building 5, Room B1-01 NIDDKD National Institutes of Health Bethesda, MD 20892 Dr. Ned Feder Review Branch, DEA, NIDDKD Westwood Building 605 National Institutes of Health Bethesda, MD 20892 Dear Walter and Ned: I received your note of February 5th. I trust you will also circulate Congressman Dingell's letter in which he disavows the report. This will put Ms. Hadley's "report" in its proper perspective. It was never released and was only a draft, points which Congressman Dingell makes clear in his letter. I also trust that by now you have circulated Dr. Healy's Chicago Tribune letter and Mr. Onek's reply to Hadley's so called "report", as you promised. When you and Serge Lang circulate these documents I trust you will do so as widely as you did the other. I agree with Mr. Dingell: it is strange, to say the least, that you took it upon yourself to circulate Hadley's garbage collection. Finally, I understand Dr. Hagins works with you. You must be aware of his bizarre and extraordinary letter to Serge Lang demanding punitive actions. I can only be glad people like him do not become judges or policemen. However, I do begin to see a link in the nature of people who take on self-righteous crusades. This was not the way to solicit a "response from me." You can add the letter of Congressman Dingell to the Web net distribution. I believe that I am owed that at the very least. Sincerely yours, Robert C. Gallo, M.D. Enclosure ------------------------------------------------- On 26 January 1995, William Hagins wrote a letter to Serge Lang suggesting steps that should be taken in the Gallo case. Subsequently, Robert Gallo called William Hagins to discuss the Gallo case with him. Hagins urged Gallo to put his reply to the draft Dingell Staff Report in writing. Subsequently Hagins received a letter dated 21 February 1995 stating his position on the matter. -------------------------------------------------- Building 5, Room 141 (301) 496-5340 (301) 496-0825 fax January 26, 1995 Professor Serge Lang Department of Mathematics Yale University Box 2155 Yale Station New Haven, CT 06520 Dear Professor Lang: Walter Stewart tells me that you have circulated copies of the Dingell Committee Staff Report on the Gallo case to about a hundred scientists and bigwigs in hopes of getting some corrective action from the government. I have read through all 336 of the depressing document and I strongly agree that NIH must do something. As a lawyer would say, the appropriate remedy should include, but not be limited to, the following: 1.) The Director, NIH should issue a public apology to the IP on behalf of present and past officials who engineered this appalling coverup, and on behalf of the scientific staff of NIH. 2.) All rights under the present HIV test patent should be assigned to the IP and Drs. Barre-Sinoussi, Chermann, and Montagnier. 3.) The Staff report of the Dingell Committee should be made a part of the NIH Annual Report for 1995. 4.) All royalties received by the U.S. government during the entire term of the patent should be remitted with interest to the Institut Pasteur. 5.) All payments to Drs. Gallo, Popovic, and Sarang should be retrieved and returned to the IP. Note that, apart from repayment of money, there is no mention of punitive actions against anyone: this is not a legal matter, it concerns the good name of NIH. I realize that Dr. Varmus would likely be fired in short order if he attempted to do any of this, but nothing would do more to create an issue that scientists, especially intramural NIH scientists, could speak out about than that! For him it would be a wonderful opportunity to become known as the first NIH Director who actually stood for something besides the efficient absorption of federal funds. I welcome suggestions. Enclosed is a check to help with your distribution costs for all of those reports. I should have sent it long ago when you were fighting the Huntington case, but better late than never. Sincerely, William A. Hagins Laboratory of Chemical Physics, NIDDK ------------------------------------------------- Bldg 37, Room 6A11 37 Convent Dr MRC 4255 Tel: 301/496-6007 Fax: 301/402/1338 February 21, 1995 Dr. William Hagins Chief Membrane Biophysics Section Laboratory of Chemical Physics NIDDKD--Bldg 5 Room 135W, NIH Bethesda, MD 20892 Dear Dr. Hagins: Further to our recent telephone conversation: You have jumped to conclusions. Your willingness to promote prosecution of people even in your ignorance of facts and complete lack of understanding of this matter does not surprise me. I have seen it before in a few others who, like you, promote an anti-scientific attitude with an attitude of self-righteousness. In the end I have learned to feel sorry for people like you who seem to get their pleasure by harming others. Dr. Hadley's report is filled with half-truths and information given out of context. She failed to understand the differences in thinking at various time periods, as knowledge of the field was unfolding. Often I am blamed for things for which no one can be blamed or for things in which I was not even involved. No doubt, however, unlike you and Dr. Hadley, I am not perfect. You said you do not believe me and yet you seek to have me write a reply. Why should I? Why would you believe a written reply if you would not believe a verbal one? Whenever I was given an open forum there were no accusations made against me. Don't you wonder why not? In the remarkable letter of Congressman Dingell, note the use of the word "Draft" and "note" and "Not checked for accuracy," etc. You even said that this was untrue. I am, therefore, sending you a copy of his letter to Dr. Varmus and two other articles which reflect a completely different perspective on this matter. Sincerely yours, Robert C. Gallo, M.D. ------------------------------------------- On 15 February 1995, Ned and I were each handed an Official Letter of Reprimand from Mr. L. Earl Laurence, Executive Officer for NIDDK, for communicating with the Ryan Commission using NIDDK letterhead. We were astonished, since we had previously received written approval from Mr. Laurence to present material to the Ryan Commission as an official duty activity. In forwarding the draft Dingell Gallo Report, we were responding to a request from a Commissioner for further written materials. Further, we had received a 28 November 1994 letter from Henrietta Hyatt-Knorr, the Executive Secretary for the Ryan Commission, explicitly requesting "Any other materials that you referred to or promised to send to the Commission." We also received a 28 November 1994 letter from Commissioner Tom Devine requesting that we "prepare and submit written testimony, as previously arranged with the Commission" and adding "If there is any problem with your obtaining the necessary permission of official time to perform this work, please contact me immediately." --------------------------------------------- February 15, 1995 TO: Dr. Ned Feder Scientific Review Administrator, NIDDK FROM: Acting Deputy Director and Executive Officer, NIDDK SUBJECT: Official Reprimand for Your Unauthorized Use of NIDDK Letterhead To Distribute a Draft Congressional Investigative Report Concerning Scientific Misconduct Issues This is an Official Reprimand effective February 15, 1995, for your unauthorized use of NIDDK letterhead to distribute a draft congressional investigative report concerning scientific misconduct issues. Specifically, I am referring to your attached January 23, 1995 correspondence with Dr. Kenneth Ryan, the chairman, and to one of the members of the Commission on Research Integrity. In this correspondence, you have used NIDDK letterhead to distribute to Dr. Ryan a draft congressional investigative report relative to scientific misconduct. This action is a flagrant violation of my directive to you that you are not to use government resources for activities related to scientific misconduct. As such, it is a direct, willful act of defiance for which this memorandum serves as a formal Official Reprimand. On April 9, 1993, I assigned you to a new position in the NIDDK because your previous work related to scientific misconduct and plagiarism was beyond the mission, authority, and responsibility of this Institute. On May 9, 1993, you received a new Position Description outlining your official duties at NIDDK. In a letter dated April 30, 1993, I instructed you "not to use Government stationery, equipment, supplies, or other resources" on activities related to scientific misconduct. Your letter and the release of a draft congressional report on scientific misconduct issues is in clear violation of these instructions. If you used other NIDDK resources, including xeroxing facilities, this would be in further violation. Your action is highly problematic for the NIDDK, in that your use of Institute letterhead incorrectly suggests that you acted in an official capacity -- with the knowledge, resources and approval of the organization. The gravity of your action is reflected by the fact that Representative John Dingell saw fit to write NIH Director Harold Varmus a letter indicating that the report you distributed was not an official congressional report. In his letter of February 3, 1995, Mr. Dingell notes: "We cannot vouch for the authenticity or accuracy of the papers provided to you. They were not reviewed, much less evaluated, by the staff director, the Chairman, or any other Member of the Subcommittee." By using NIDDK letterhead to release a draft congressional report that the cognizant congressional subcommittee chose not to issue, you have wrongly implicated this Institute in your action, thereby placing this organization in an extremely difficult position vis-a-vis the congressional subcommittee whose report you distributed. I want to emphasize again that any work you do relative to issues of scientific misconduct is not within the NIDDK mission and must be done on your own time, with your own resources, and under your own private aegis. You are not to use government time, xeroxing facilities, wordprocessing or other equipment, postage, paper, NIDDK letterhead, or any other governmental resource for this purpose. Should you disregard my directive again, I will be compelled to initiate further disciplinary action. This Official Reprimand will be made a part of your Official Personnel Folder (OPF) for a period of time of no more than 2 years, at which time it will be removed and destroyed. The material upon which this Official Reprimand is based is located in the NIDDK Personnel Office, Building 31, Room 9A30. You may contact Ms. Joanna Voight at 496-4231, if you wish to review this material. You have a right to file a grievance regarding this Official Reprimand. In accordance with the attached HHS Instruction 771-3, Employee Grievances, you must submit your grievance to me no later than 30 calendar days following the effective date of this action. If you believe that this Official Reprimand is based on discrimination because of your race, color, religion, gender, sexual orientation, nation of origin, physical or mental disability, or age, you may file a discrimination complaint with the Department under the provisions of the HHS Personnel Instruction 1613-3. To do so, you must consult an EEO Counselor within 45 calendar days after the effective date of this action. You should note that matters covered in complaints of discrimination are excluded from coverage under this Department's grievance procedure. If you have any questions concerning this action, please contact Ms. Voight at 496-4231. Again, she is located in Building 31, Room 9A30. L. Earl Laurence Attachments: January 23, 1995 Correspondence Letter from Mr. Dingell HHS Instruction 77-3, Employee Grievance cc: Dr. Robert Hammond Official Personnel Folder (OPF) ------------------------------------------- November 28, 1994 Mr. Walter Stewart NIDDK Office of Program Planning and Evaluation Building 31, Room 9A07 National Institutes of Health Dear Mr. Stewart: Dr. Ryan, Chair of the Commission on Research Integrity, has asked me to thank you for sharing with the Commission your knowledge of select issues in scientific misconduct. Any other materials that you referred to or promised to send to the Commission should be forwarded to me at your earliest convenience. One of the Commission Members, Mr. Devine, has expressed interest in some additional help from you. Please call him directly at (202) 408-0034. Thank you. Sincerely, Henrietta D. Hyatt-Knorr Executive Secretary, Commission on Research Integrity cc: Dr. Ryan Mr. Devine -------------------------------------------- November 28, 1994 Mr. Walter Stewart Building 31, Room 9A-19 National Institutes of Health Bethesda, MD 20892 Dear Mr. Stewart, You will be shortly receiving a letter on behalf of the Commission on Research Integrity requesting tht you prepare and submit written testimony, as previously arranged with the Commission, and also requesting that you assist the Commission in other tasks. The letter is because I informed commission staff working out of the Office of Research Integrity that I needed your assistance. I am asking that initially you be available on November 29 and 30 to help prepare testimony for the next hearing, and that you be available on December 1 and 2 to attend the hearing. Thank you for your continued cooperation. Because of your and Mr. Stewart's unique expertise as Department of Health and Human Services employees who have worked with whistleblowers on charges involving scientific misconduct, your anticipated contribution is vital for the Commission to conduct effective hearings. If there is any problem with your obtaining the necessary permission or official time to perform this work, please contact me immediately. Sincerely, Thomas Devine --------------------------------------------- We summarized the reasons why it appeared correct to use letterhead in a memorandum of 26 February 1995 and an accompanying memorandum of 25 February to Mr. Laurence. The incident was covered in an article in the 1 March 1995 issue of Science & Government Report. ---------------------------------------------- DATE: 26 February 1995 TO: Mr. L. Earl Laurence, Acting Deputy Director and Executive Officer, NIDDK FROM: Ned Feder, Scientific Review Administrator, RB, DEA, NIDDK Walter W. Stewart, Technical Information Specialist, OPPE, NIDDK SUBJECT: Request That You Reconsider Your Letters of Reprimand On 23 January 1995, pursuant to a request from a member of the Ryan Commission, we disclosed information on a case of alleged scientific fraud (the Gallo case) to Chairman Ryan. The draft Staff Report of the Dingell Subcommittee that we forwarded gives information on a major scientific scandal directly affecting the public health. We had previously been authorized to give testimony to the Commission as an official duty, and we were responding to a request from a Commissioner. The information we disclosed was deemed useful by the Chairman. He wrote to Serge Lang, who subsequently furnished the same information, that the information "obviously should inform our work and help our deliberations." On 15 February we received from you formal Letters of Reprimand for our use of letterhead in writing Chairman Ryan. The attached memorandum of 25 February 1995 sets forth the reasons why our use of letterhead was appropriate. Your letters of reprimand appear to violate certain federal laws. We request that you reconsider and withdraw these letters. Our goal is to solve this question, not to make a "federal case" out of it. We think a constructive resolution is preferable to a legal conflict on this matter. Please have a DHHS attorney contact our attorney, Mr. Gary Simpson, to see if this matter can be resolved. (We are of course not waiving our right to file a grievance or complaint with the Office of Special Counsel in the absence of a timely resolution of this matter.) The situation is truly Kafkaesque: we forwarded information on the Gallo fraud -- a major scientific fraud that directly affects the public health. We receive, not a response to the scientific fraud, but a complaint that we used the wrong letterhead. The situation would be comical if it did not have a direct bearing on public health and the integrity of science. -------------------------------------------------- The following letter was not dated, but was postmarked 7 February 1995. Dear Dr. Lang, Thank you for sending me the Gallo report. I will have it reproduced for all our Commission members. It obviously should inform our work and help in our deliberations. I am wondering whether the new congress will be at all interested in it. It will be interesting to see what the response of the scientific community will be. You are to be commended for taking the time and effort to deal with the scientific integrity issue. Sincerely, Kenneth J. Ryan, M.D. ------------------------------------------ DATE:25 February 1995 TO: Mr. L. Earl Laurence, Acting Deputy Director and Executive Officer, NIDDK FROM: Ned Feder, Scientific Review Administrator, RB, DEA, NIDDK Walter W. Stewart, Technical Information Specialist, OPPE, NIDDK COPIES: Dr. Kenneth J. Ryan, Mr. Thomas Devine, Dr. Harold Varmus, Dr. Phillip Gorden, Ms. Carol Feld, Dr. Walter Stolz, Dr. Robert D. Hammond SUBJECT: Your Instructions to Us and the Applicable Laws Suggest Our Use of Letterhead Was Appropriate We request that you reconsider your 15 February Letters of Reprimand (Attachments 26, 27) for what you term "unauthorized use of NIDDK letterhead to distribute a draft congressional investigative report concerning scientific misconduct issues" in a letter (Attachment 21) we sent on 23 January 1995 to Dr. Kenneth Ryan, Chairman of the Commission on Research Integrity. The facts plainly show that we had been authorized to testify before the Ryan Commission as an official duty activity, and that the action for which we were reprimanded was a continuation of an authorized activity. Your Letters of Reprimand further appear to violate a number of laws. Our reasons for requesting reconsideration are as follows. 1. Your reprimand is inconsistent with your prior approval of analogous disclosures. You did not notify us that your policy had changed. 2. The disclosure by us was in response to a request from a member of the Commission on Research Integrity appointed by the Secretary of Health and Human Services. This is a blue-ribbon panel mandated by Congress whose members were appointed by Secretary Shalala (Attachment 20). The Commission on Research Integrity, chaired by Dr. Kenneth Ryan, has a vitally significant mission for scientific integrity, public health, and the lessening of fraud, waste, and mismanagement of federal grants. The Reprimands directly interfere with the work of the Commission. 3. The disclosure is consistent with NIDDK policy to help the Commission, as recently stated by you. It seems inconceivable that it is NIDDK policy to officially suppress information such as that contained in the Gallo draft report. 4. The disclosure concerned issues of the highest public policy significance -- alleged fraud, mismanagement, and waste of taxpayer funds that threaten the integrity of scientific research into what is widely regarded as the most severe threat to public health facing the nation: AIDS. Millions of Americans are at risk for premature death because of this epidemic. Our disclosure shows how breaches of scientific integrity set back AIDS research around the world, doubtless risking thousands or more unnecessary deaths. The information in the draft report on the Gallo case provides evidence how, when the allegations of misconduct were not dealt with appropriately, the result ...was a costly, prolonged defense of the indefensible.... The consequences for HIV research were severely damaging, leading, in part, to a corpus of scientific papers polluted with systematic exaggerations and outright falsehoods of unprecedented proportions. The American public has a right to know that the government is misspending taxpayer funds appropriated to defend against this public health menace. 5. The disclosure is consistent with public testimony to the Ryan Commission by a responsible NIH official who described what scientists "need" and have a "duty as public employees" to do. 6. A similar disclosure was subsequently made to the Ryan Commission by Yale mathematician Serge Lang. Chairman Ryan wrote him that the report "should inform our work and help in our deliberations." This shows our belief was well founded that the draft report would prove useful to the Ryan Commission. 7. The Reprimands are discriminatory, because we have made many legally analogous disclosures and have done so using NIDDK letterhead stationery over a period of many months to other HHS offices, including your own. These disclosures have not been subject to criticism by you or anyone else. The only relevant distinction here is that the disclosures in question were made to the Ryan Commission. 8. The Reprimand is explicitly because of a disclosure that is protected under the Whistleblower Protection Act. As a result, the disclosure may not lawfully be used for disciplinary action against us. Your Letters of Reprimand are also inconsistent with other Federal laws including those controlling appropriations for federally funded research. 9. A stated basis for the Reprimands -- the preliminary nature of the congressional staff report on alleged misconduct in connection with federally funded AIDS research -- is not legally relevant to the protected nature of our disclosure under the Whistleblower Protection Act. What is important is not the preliminary nature of the report, but the information in the draft report we disclosed. 10. Your Letters of Reprimand will have a chilling effect on the willingness of federal scientists to communicate with the Ryan Commission. The above reasons for requesting reconsideration are discussed in greater detail below. History of Our Appearance Before the Ryan Commission On 29 September 1994 we received letters (Attachments 8, 9) from Ms. Henrietta Hyatt-Knorr on behalf of the Ryan Commission inviting us to testify. On 30 September one of us (Ned Feder) replied to Ms. Hyatt-Knorr on letterhead stationery (Attachment 10) that he would accept the invitation "after my request to do so has been approved by my supervisor, Dr. Robert Hammond, Chief of the Review Branch." Soon afterward Dr. Feder learned that the appropriate official to give approval was you, not Dr. Hammond. On 4 October, Dr. Feder wrote you a memorandum on NIDDK letterhead (Attachment 11) seeking approval to appear before the Ryan Commission "as an official duty activity." On 11 October 1994 (Attachment 12) you replied favorably to the request, stating: It is the practice of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to make the members of the staff available to any duly constituted commission of the Department of Health and Human Services. I am, therefore, approving your request to appear before the Commission on Research Integrity in response to their invitation on regular duty time. In addition, you asked for an additional few hours for work related to that appearance. I am approving that request as well for up to approximately 6 hours of duty time. Each of us received a memorandum (Attachment 13) from you approving this activity. A month later, on 7 November 1994, we testified before the Ryan Commission on regular duty time. We used NIDDK resources to prepare our testimony. Consistent with our performing this activity as an official duty activity, the first page of our testimony was on letterhead bearing DHHS and NIDDK logos (Attachments 14, 15). We made it clear in our spoken and written testimony that we were appearing as NIH scientists. We stated: We are appearing here as NIH scientists. As is customary in science, the views we are stating are our own, and we are not acting as spokesmen for NIH [emphasis added]. During our appearance before the Commission, we received a request from a member of the Commission to provide additional information after the hearing. Our letter of 23 January -- the stated reason for your Letters of Reprimand -- was responsive to this request. Your Letters of Reprimand do not mention your explicit approval of our appearance before the Ryan Commission nor our previous and unchallenged use of letterhead for this and closely related purposes. The Letters of Reprimand thus do not present a complete view of the facts. 1. Your reprimand is inconsistent with your prior approval of analogous disclosures. You did not notify us that your policy had changed. On 4 October 1994, you gave us explicit permission to appear before the Ryan Commission as an official duty activity. Our use of letterhead in presenting our testimony was not challenged then or now. Our use of letterhead to communicate with Dr. Ryan on the business of the Commission was the reason given for your Letters of Reprimand. Our communication with Dr. Ryan by letter was clearly a continuation of our communication with the Commission at its hearing, an activity that had been approved as official. Why was it acceptable to use letterhead to communicate with the Commission on and before 7 November 1994, but not on 23 January 1995? What changed? 2. The disclosure by us was in response to a request from a member of the Commission on Research Integrity appointed by the Secretary of Health and Human Services. This is a blue-ribbon panel mandated by Congress whose members were appointed by Secretary Shalala (Attachment 20). The Commission on Research Integrity, chaired by Dr. Kenneth Ryan, has a vitally significant mission for scientific integrity, public health, and the lessening of fraud, waste, and mismanagement of federal grants. The Reprimands directly interfere with the work of the Commission. Mr. Devine stated to us at the hearing (Attachment 18): I am wondering if you could prepare for us maybe a packet, for us to do more studying, of any of the restrictions on disclosure that have inhibited you from being as effective as you think you could have, any lessons that you have learned from working on specific cases. [Emphasis added.] The information we furnished on 23 January -- in our letter to Dr. Ryan for which we are being officially reprimanded -- was on a specific case highly relevant to the work of the Commission. Our letter and its enclosure was responsive to the request of a Commissioner for more information. It would have been less than polite for us to fail to honor a request for information made by the Ryan Commission to us during our appearance there. If we had failed to cooperate with the Ryan Commission by withholding the draft report, we would have failed to discharge our obligation to the Ryan Commission. 3. The disclosure is consistent with NIDDK policy to help the Commission as recently stated by you. It seems inconceivable that it is NIDDK policy to officially suppress information such as that contained in the Gallo draft report. In your letter of 11 October 1994 (Attachments 12, 13)) you wrote: It is the practice of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to make the members of the staff available to any duly constituted commission of the Department of Health and Human Services. Thus our letter of 23 January to Dr. Ryan is consistent with NIDDK policy as stated by you. The NIDDK policy of making "members of the staff available" clearly implies making the information they have available as well. Further, as shown below, it is our obligation as federal employees to disclose such information. 4. The disclosure concerned issues of the highest public policy significance -- alleged fraud, mismanagement, and waste of taxpayer funds that threaten the integrity of scientific research into what is widely regarded as the most severe threat to public health facing the nation: AIDS. A governmental body such as the Ryan Commission is an appropriate body to receive the Gallo draft report. We have had every expectation that the Ryan Commission would deal responsibly with the information we disclosed. A failure on our part to furnish this document to the Ryan Commission would deprive it of the opportunity to evaluate how the alleged fraud in the Gallo case was handled. We reasonably believed that public policy favored disclosure as opposed to silence. The arguments for disclosure seem particularly compelling because the disclosure concerned a AIDS, a disease that is a major threat to the health of Americans. 5. The disclosure is consistent with public testimony to the Ryan Commission by a responsible NIH official who described what scientists "need" and have a "duty as public employees" to do. At the 7 November 1994 Ryan Commission meeting, Dr. Joan P. Schwartz, Special Assistant to the Deputy Director for Intramural Research, was asked what NIH scientists should do if they "stumbled across" evidence indicating scientific misconduct. The question as posed to Dr. Schwartz concerned misconduct by extramural scientists, but the context and logic indicates that the question and answer apply equally to information indicating misconduct by any publicly supported scientist. Dr. Schwartz replied (Attachment 16): They need to refer it to someone under federal regulations. It is our duty as public employees to report such things. I would guess that ORI might be the best, because obviously intramural programs cannot investigate extramural. A subsequent interchange (Attachment 17) between Mr. Devine, Dr. Schwartz, and Dr. Ryan made it clear that such information could equally well be forwarded to the Ryan Commission: MR. DEVINE: I just wanted to make sure there was not any confusion in the aftermath of your answer, an NIH scientist who stumbles across something that is extramural, can refer it to ORI, OIR, or OER. How about CRI? DR. SCHWARTZ: I do not know what that is. MR. DEVINE: Commission on Research Integrity. Can they share that with us. DR. SCHWARTZ:Sure, absolutely. DR. RYAN:Thank you very much. We would appreciate having that.... Thus in disclosing to the Ryan Commission information about possible misconduct on the part of Dr. Gallo and senior DHHS officials, we were following to the letter the policy approved "absolutely" by Dr. Schwartz. The explicit context for Dr. Schwartz's advice was an inquiry about her Office's "guidance for NIH scientists." The question and the answer was about what actions employees should take as NIH scientists, not as private citizens. Dr. Schwartz made clear that NIH scientists had a duty precisely because they were public employees. She made no suggestion that -- for relevant disclosures within the government generally or to the Ryan Commission specifically -- NIH scientists, in carrying out these duties, must identify themselves as private citizens and refrain from using agency stationery or other resources. Thus our actions were in conformity with Dr. Schwartz's statement about our duties to provide material as NIH scientists. Our actions were also consistent with the statement of the Chairman making it clear that the Commission would appreciate having such material. 6. A similar disclosure was subsequently made to the Ryan Commission by Yale mathematician Serge Lang. Chairman Ryan wrote him that the report "should inform our work and help in our deliberations." This shows our belief was well founded that the draft report would prove useful to the Ryan Commission. Serge Lang also sent the draft Staff Report to the Ryan Commission. The Chairman Ryan wrote Lang a letter (Attachment 25) thanking him for the submission and praising him for his interest in the scientific integrity issue. The letter stated: Thank you for sending me the Gallo report. I will have it reproduced for all our Commission members. It obviously should inform our work and help in our deliberations. I am wondering whether the new congress will be at all interested in it. It will be interesting to see what the response of the scientific community will be. You are to be commended for taking the time and effort to deal with the scientific integrity issue. These words of praise from Chairman Ryan confirm our belief that the document would be helpful to the official deliberations of the Commission. 7. The Reprimands are discriminatory, because we have made many legally analogous disclosures and have done so using NIDDK letterhead stationery over a period of many months to other HHS offices, including your own. These disclosures have not been subject to criticism by you or anyone else. The only relevant distinction here is that the disclosures in question were made to the Ryan Commission. The occasions on which we have used letterhead without any reservations either verbal or written include those listed in Appendix A. Of the examples cited, the 23 January 1995 letter (Attachment 22) to Dr. Varmus is noteworthy, since the subject matter is very similar to that in our letter of 23 January to Dr. Ryan, and the relevant enclosures are identical. One letter was to an official of NIH; the other to a member of a DHHS-appointed Commission. We subsequently wrote to Dr. Varmus on letterhead on 5 February 1995 (Attachment 24) urging him to do something about the Gallo scandal. Your reply of 15 February 1995 (Attachments 28, 29) on behalf of Dr. Varmus failed to respond to the points we had raised and did not object to our use of letterhead to correspond with Dr. Varmus. As noted, we used letterhead stationery in our communications prior to and during the Commission's hearing of 7 November. Not one of these uses of letterhead stationery has ever been subject to spoken or written criticism, by you or anyone else. These uses of letterhead were well known to you and to other officials of NIH and DHHS. We note in particular that we forwarded our allegations involving Dr. Chen, Dr. Gallo and others on letterhead stationery (see Appendix A). None of these communications on letterhead have been criticized by you or anyone else as an inappropriate use of letterhead. The only legally relevant distinction for the disclosure resulting in our Reprimand was that this particular disclosure was made to the Ryan Commission. What we did is nothing more than communicate as one DHHS entity to another. There is absolutely nothing wrong with using letterhead in communications between DHHS entities for something which is manifestly not personal business. We do not understand how a supervisor can reprimand a subordinate for doing this. 8. The Reprimand is explicitly because of a disclosure that is protected under the Whistleblower Protection Act. As a result, the disclosure may not lawfully be used for disciplinary action against us. Your Letters of Reprimand are also inconsistent with other Federal laws including those controlling appropriations for federally funded research. Whistleblower Protection Act. This federal law states (Attachment 30): Any employee who has authority to take ... any personnel action, shall not ... take ... a personnel action with respect to any employee ... because of -- (A) any disclosure of information by an employee ... which the employee ... reasonably believes evidences -- (i) a violation of any law, rule, or regulation, or (ii) gross mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety.... Our letter of 23 January and its attachments clearly contain information that falls into the above categories (i) and (ii). Accordingly, this letter constitutes a protected disclosure under the Whistleblower Protection Act. The law states that you may not take a personnel action because we made this disclosure. The draft report we sent Dr. Ryan discloses hundreds of items of information with a direct bearing on categories (i) and (ii). In some cases where prohibited personnel practices are alleged, it is difficult to demonstrate that the adverse personnel action was taken against an employee because the employee had disclosed information. There is no such difficulty here. Your Letters of Reprimand state that we are being reprimanded because of the disclosure (which you refer to as the use of NIH letterhead stationery to "release" information). Accordingly, your Letters of Reprimand appear to constitute a violation of the Whistleblower Protection Act. Code of Ethics for Government Service. This Federal law, 45 CFR Part 73, Appendix B, states (Attachment 31): "Any person in Government service should": Expose corruption wherever discovered. Congress mandated the posting of the Code in federal government buildings. By sending the letter of 23 January to Dr. Ryan, along with the enclosures, we were acting in conformity with this law. Anti-Gag Statutes. Section 620 of Public Law 103-329 expressly prohibits the use of government resources to block disclosures of the sort we made in our letter of 23 January to Dr. Ryan. Specifically, the law states in part (Attachment 32): No funds appropriated in this or any other Act ... may be used to implement or enforce ... any ... nondisclosure policy, form or agreement if such policy, form or agreement does not contain the following provisions: "These restrictions are consistent with and do not supersede, conflict with or otherwise alter the employee obligations, rights or liabilities created by ... section 2302(b)(8) of title 5, United States Code, as amended by the Whistleblower Protection Act (governing disclosures of illegality, waste, fraud, abuse or public health or safety threats).... The definitions, requirements, obligations, rights, sanctions and liabilities created by said Executive Order and listed statutes are incorporated into this Agreement and are controlling." None of these restrictions imposed by you on our speech contained the required provision imposed by this law. These restrictions are therefore void to the extent that they conflict with the terms of the law. It appears that your previous letters to us (of 30 April 1993; Attachments 1, 2), mentioned prominently in your Letters of Reprimand, are also inconsistent with this federal law. It appears that your letters of 15 February 1995, and actions associated with these letters and the earlier letters, illegally make use of federal funds for implementation and enforcement. Section 1301 of Title 31 states (Attachment 33): "Appropriations shall be applied only to the objects for which the appropriations were made except as otherwise provided by law." In addition, Section 3528 states (Attachment 35) that a certifying official is responsible for repayment of an expenditure that is "(A) illegal, improper, or incorrect because of an inaccurate or misleading certificate; (B) prohibited by law; or (C) that does not represent a legal obligation under the appropriation or fund involved." According to the texts of the laws quoted, it appears: That federal funds spent in connection with your imposed limitations on our disclosure of information were not authorized by law, That such funds should be returned by the certifying official to the United States Treasury. The various gag orders issued to us, and their apparent violation of federal laws, are discussed more fully in Appendix B. 9. A stated basis for the Reprimands -- the preliminary nature of the congressional staff report on alleged misconduct in connection with federally funded AIDS research -- is not legally relevant to the protected nature of our disclosure under the Whistleblower Protection Act. What is important is not the preliminary nature of the report, but the information given in the draft report we furnished. Your Letters of Reprimand state: The gravity of your action is reflected by the fact that Representative John Dingell saw fit to write NIH Director Harold Varmus a letter indicating that the report you distributed was not an official congressional report. We are at a loss for how this statement is relevant. That Representative Dingell chose to write a letter (Attachment 23) stating his position on the report has nothing to do with the "gravity" -- let alone the propriety -- of our actions. Our actions in disclosing this information are not "grave" in any sense -- they are simply those called for by the Code of Ethics for Government Service and are consistent with the Whistleblower Protection Act and relevant appropriations laws. In addition, the actions we took are deemed our "duty as public employees" in public testimony at the Ryan Commission hearing by Dr. Joan P. Schwartz, Special Assistant to the Deputy Director for Intramural Research. As for the accuracy of the assertions in the draft report: the Dingell staff has a reputation for accuracy, and Congressman Dingell himself, in his letter of 3 February 1995 to Dr. Varmus, does not repudiate the report or deny its validity. Moreover, a Pulitzer prize-winning journalist, Mr. John Crewdson, with a reputation for high journalistic standards, has published material taken from the report (Attachment 19). Perhaps most important: many of the crucial assertions in the report can be easily verified by someone with access to the relevant documents. Thus we continue to believe it was both reasonable and desirable to bring the report to the attention of the Ryan Commission, even though it was a draft report, not a final report. Nothing in our disclosure is inconsistent with the letter of Representative Dingell. We agree with his statements about the context of this document. It is a draft or preliminary report, not a final conclusion of the congressional Committee. That the document is a draft and not a final report is not the issue. The point is the information, not the context. The Ryan Commission should be properly informed about this issue so that it can follow its progress, which has important implications for public health. Your citation of Congressman Dingell's statements goes at most to the merits of the report, rather than our use of letterhead. Nothing in our transmittal indicates that we believed the report was anything more than a draft report. Consequently, nothing that Congressman Dingell subsequently said makes our use of letterhead wrong. Your citation of Congressman's Dingell's statements suggests that we are being reprimanded for the information disclosed in the report, rather than for our use of letterhead. 10. Your Letters of Reprimand will have a chilling effect on the willingness of federal scientists to communicate with the Ryan Commission. The "120-Day and First Annual Report" of the Ryan Commission states (Attachment 20) that ... an essential component of the Commission's data-gathering is to interact extensively with all relevant constituencies of the scientific community -- including witnesses, respondents, and academic and Federal program administrators.... Your Letters of Reprimand directly interfere with the flow of information that the Commission has deemed an "essential component" of its "data-gathering." The argument you made in our case -- that misconduct is not in our job descriptions and hence we may not communicate on letterhead with the Ryan Commission -- could be applied to almost all federal scientists. What federal scientist will be willing to risk a Letter of Reprimand in order to communicate officially with the Ryan Commission? If scientists are forbidden to communicate officially with the Ryan Commission, will they not feel they are taking a risk in doing so in their personal capacity? If those in authority forbid communication officially, they clearly frown upon it in any setting, official or private. We suggest that the great majority of scientists will conclude that the communication is not worth the risk. Your harsh actions in our case, if not rescinded, are certain to be widely known in the scientific community. Your actions and your Letters of Reprimand pose a threat to us if we continue to make legally protected disclosures. The Bottom Line We forwarded documents to the head of an official DHHS Commission charged with making recommendations on the handling of scientific misconduct. The documents provide detailed, easily verifiable evidence of (1) a major scientific fraud on (2) a disease, AIDS, with great significance for the public health. The response? We are issued Letters of Reprimand for using letterhead stationery to forward the documents. Not a word about the evidence of fraud and coverup. There appears to be serious confusion and contradictory guidance about our rights and responsibilities as employees covered by civil service merit system laws. There are similar problems with our rights and responsibilities as NIH scientists who come across evidence of scientific misconduct. We know that you support the purposes and work of the Commission on Research Integrity. The Commission's First Annual Report (Attachment 20) concluded that ...any environment offering potential witnesses the choice between reprisal and silence is unacceptable, because the public-policy stakes for research integrity are too high.... The Commission believes that both dishonesty and secrecy are incompatible with the very meaning of science. Science is a search for truth that learns from mistakes and cannot tolerate deception. We seek your support in working with us to honor that fundamental principle we all have an obligation as public servants to uphold. Appendix A Correspondence On Letterhead Stationery Related To Scientific Misconduct From Stewart and Feder Between 9 April 1993 and the Present The following documents were typed on letterhead stationery. The use of letterhead for these documents has never been criticized. 12 April 1993. Feder and Stewart to Laurence. "We feel certain we can demonstrate the relevance of our work on scientific misconduct to the mission of the NIH.... Indeed, our work on scientific misconduct generally receives wide public recognition just because of its obvious relevance to the integrity of the biomedical research process.... Our work on scientific misconduct has resulted in serious findings of both erroneous and fraudulent scientific research." 26 April 1993. Feder and Stewart to all NIDDK scientists. "Our work has shown, by specific example, ... that famous and respected scientists can behave in professionally dishonorable ways...." 18 May 1993. Feder and Stewart to Laurence. "A decision on your part not to approve the talk [about a computer program to assist in the detection and analysis of plagiarism] would appear to violate federal regulations on dissemination of scientific and professional information by NIH employees. Moreover, such a prohibition, by preventing free and open debate on an important subject, would clearly be contrary to the spirit and practice of science in good academic institutions." 18 May 1993. Feder to LaRoche. "Title [of proposed talk by Stewart and Feder]: Analysis and discussion of recent events at NIH.... The general subject is a computer program -- sometimes referred to as a plagiarism program or plagiarism machine...." Handwritten reply from Becich, Executive Office, Clinical Center: "Turned down -- not related to mission of NIH." 21 May 1993. Stewart and Feder directly to Laurence. "A decision on your part not to approve the talk [on a computer program to assist in the detection and analysis of plagiarism] would appear to violate federal regulations on dissemination of scientific and professional information by NIH employees. Moreover, such a prohibition, by preventing free and open debate on an important subject, would clearly be contrary to the spirit and practice of science in good academic institutions." 24 May 1993. Feder and Stewart to LaRoche. "We will discuss the program outlined above and present some results obtained in literature and science with this plagiarism program." 24 May 1993. Feder through Hammond and Stolz to Laurence. Similar to memorandum of 21 May 1993. 24 May 1993. Stewart through Eaton and Spiegel to Laurence. Similar to memorandum of 21 May 1993. 4 October 1993. Stewart and Feder to Laurence. "We suggest that NIDDK (or the Office of the Director, or the Assistant Secretary of Health) establish at NIH an Office of Whistleblower Assistance (OWA) initially staffed by us.... We would function as scientists assisting colleagues who want help. In addition, we would do research. We would have no powers of enforcement. We would function solely as scholars." 9 October 1993. Stewart and Feder to Macfarlane. "We hereby submit a formal complaint of scientific misconduct consisting of theft of research and professional credit.... We have discovered what appears to be corruption. Since we are government employees, we are under a direct legal obligation to ensure that it is exposed." 10 October 1993. Stewart and Feder to Laurence. "In the case of Dr. John Robbins and associates, now under review by both ORI and OEO, it appears that, in connection with an effort to steal scientific credit, high NIH officials may have engaged in activities that were improper, illegal, and possibly corrupt. In addition, there are serious unresolved questions about the integrity of data for a draft manuscript in the same case." 16 December 1993. Stewart and Feder to Kiang. "At your request and the request of Dr. Chen, we are specifying our allegations of scientific misconduct.... The evidence available to us at present suggests that it is more likely than not that much of the evidence [for the draft Science manuscript] has been fabricated or falsified." 20 December 1993. Stewart and Feder to Varmus. "Serious questions have recently been raised about the integrity of data for these animal studies. Thus NIH is currently conducting experiments in humans based on animal studies whose validity is in question...." 2 January 1994. Stewart and Feder to Gottesman. "Subject: Dr. Chen's repeated failures to secure documents for inquiry into Cryptococcal vaccine." 6 January 1994. Devi, Stewart, and Feder to Kiang. "This letter is to formally request the presence of the following witnesses at the meeting of the Committee scheduled for 20 January 1994: [list of 12 names]." 9 January 1994. Stewart and Feder to Kiang. "We believe there is strong evidence of fraud, theft and coverup that would emerge from a well-run investigation, but which is unlikely to emerge from the present badly flawed process." 30 April 1994. Stewart and Feder to Varmus. "Based on our own observations and consistent with the recommendations of the Kiang Inquiry Panel, we consider it likely that the manuscript on the mouse protection studies by Drs. Williamson, Bennett, Robbins and Schneerson is based on falsified or fabricated data.... In the recent incident of fraud in breast cancer research, authorities at NIH had serious doubts about the integrity of data, but for two years failed to provide this information to patients and their physicians, to the scientific community, and to the public at large. The NIH should not commit the same breach of trust again." 24 August 1994. Feder to Gottesman. "Given NIH's insistence that universities provide training on this subject [the responsible conduct of research], and given the actual amount of the training that is now taking place [elsewhere], it is striking that intramural NIH has no similar courses.... I am writing to recommend that you issue a directive to create a lecture series at NIH on the responsible conduct of research.... Aside from the extraordinary disparity between intramural and extramural NIH practices, there is another reason for giving a series of talks. We all know that the pressures on scientists to cut corners and engage in irresponsible conduct in their research are considerable, and that some scientists are unable to resist them. When people avoid talking frankly with each other about this kind of problem, it tends to fester. Would you not agree that it is worthwhile to encourage open discussion of this subject among NIH scientists?" 7 October 1994. Feder and Stewart to Gottesman. "What is the status of any response by ORI or NIH to our statement that [it] is more likely than not that much of the evidence for a manuscript submitted to Science magazine has been fabricated or falsified? ... Have patients receiving the cryptococcal vaccine been informed of doubts about the experimental data for the animal studies of the vaccine?" 23 January 1995. Stewart and Feder to Varmus. "We enclose a draft report on an investigation of the Gallo case by the staff of a subcommittee headed by Congressman John Dingell.... The draft raises serious questions about possible misconduct in a particular case.... We believe that these issues of conduct and misconduct in science are best addressed through ... free and open debate -- a process that has long been traditional in science and is an essential part of self-regulation in science. The NIH's continuing imposition of a gag order on our speech is unfortunately not consistent with this tradition." 5 February 1995. Stewart and Feder to Varmus. "There are three situations at NIH which you should fix immediately. Each shames the NIH and is an imposition on the public that paid for the NIH research. Each represents a continuing threat to the responsible conduct of science." Appendix B The NIH Gag Orders and Federal Law There are several separate, written gag orders imposed on us by NIH. (1) Two are contained in letters of 13 May 1993 (Attachments 3, 4), sent separately to Stewart and Feder by Mr. L. Earl Laurence. The letters say: "you may not use any Government facilities or resources to pursue this activity." (2) This restriction has been applied in a very literal way. Our request for approval to give a talk on the subject of scientific misconduct was turned down on 25 May 1993 by Mr. Laurence (Attachment 5): "As stated in previous correspondence, you are not to continue your former activities; therefore, approval to discuss work on official duty time related to activities preceding your reassignment is not approved." (3) The letters of 13 May 1993 to Stewart and Feder also contain a restriction against speaking on scientific misconduct on their own time as private citizens: "In addition, you cannot use any information that is available to you as a Government employee but is not available to the general public." It is not explained how one is to determine what information is or is not available to the general public. (4) These two gag orders would appear to cover virtually all contingencies, but apparently the authorities felt they were not stringent enough. On 22 September 1993, a letter (Attachment 7) of Laurence to Stewart contained yet another gag order: "Neither Drs. Spiegel, Eaton, nor other people in the lab wish to engage in philosophical discussion of scientific practice and misconduct with you. Rather, I would remind you that any allegations of scientific misconduct should be reported to the Office of Research Integrity, and allegations of other types of misconduct should be reported to the Office of the Inspector General." A similar letter was sent to Feder (Attachment 6). The prohibition, to a scientist, of philosophical discussions about scientific practice would be laughable if it did not have such serious consequences. The Gag Orders and the Law Section 620 of Public Law 102-393 (Attachment 32) provides that: No funds appropriated in this or any other Act for fiscal year 1995 may be used to implement or enforce the agreements in Standard Forms 312 and 4355 of the Government or any other nondisclosure policy, form or agreement [emphasis added] if such policy, form or agreement does not contain the following provisions: "These restrictions are consistent with and do not supersede, conflict with or otherwise alter the employee obligations, rights or liabilities created by Executive Order 12356; section 7211 of title 5, United States Code (governing disclosures to Congress); section 1034 of title 10, United States Code ...." The gag orders issued to Stewart and Feder and described above contain no such provision and therefore appear not to comply with Section 620. Title 31, Section 1301 (Attachment 33) states in part: "Appropriations shall be applied only to the objects for which the appropriations were made except as otherwise provided by law." Title 31, Section 1341 (Attachment 34), "Limitations on expending and obligating amounts," states in part: "(a)(1) An officer or employee of the United States Government or of the District of Columbia government may not -- (A) make or authorize an expenditure or obligation exceeding an amount available in an appropriation or fund for the expenditure or obligation; or (B) involve either government in a contract or obligation for the payment of money before an appropriation is made unless authorized by law." Enforcement of the Law Title 31 is not without teeth. Section 3528 (Attachment 35), "Responsibilities and relief from liability or certifying officials" provides in part: (a) A certifying official certifying a voucher is responsible for -- (1) information stated in the certificate, voucher, and supporting records; (2) the computation of a certified voucher under this section and section 3325 of this title [31 USCS � 3325]; (3) the legality of a proposed payment under the appropriation or fund involved; and (4) repaying a payment -- (A) illegal, improper, or incorrect because of an inaccurate or misleading certificate; (B) prohibited by law; or (C) that does not represent a legal obligation under the appropriation or fund involved. ***********************************************************************