Letter to Peter Likins, Ph.D., President of the University of Arizona
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ROBERT K. WREDE
Parker, Milliken, Clark, O'Hara & Samuelian May 29, 1998
Peter Likins, Ph.D. Re: In the Matter of the Hearing Before the University of Arizona Committee on Academic Freedom and Tenure Regarding Marguerite M.B. Kay, M.D. Dear President Likins: Pursuant to 42 C.F.R. 50.103(d)(3), I am writing on behalf of my client, Dr. Marguerite Kay, to comment on selected aspects of the May 4, 1998 findings and recommendations of the Panel formed by the University Committee on Academic Freedom & Tenure ("CAFT") to hear charges against Dr. Kay, and the Panel's related Appendix respecting the captioned matter (the later received in my office on May 11, 1998). In light of the lengthy catalogue of procedural and substantive errors which have pervaded the University's proceedings against Dr. Kay from the very outset, it would be a practical impossibility to address each and every error in the lengthy process leading up to the Hearing Panel's recommendations to you. Thus, I have commented only upon the most egregious of such errors. Consequently, my efforts to limit the topics addressed in this letter should not be construed as, nor are they intended to be, a waiver of any unaddressed issues. As discussed in considerable detail below, we believe both that there were serious procedural defects in the University's handling of its investigation of Dr. Kay, and that the Hearing Panel's May 4th report to you suffers from equally serious substantive errors, including biased reporting of the evidence, extensive factual omissions, and a number of outright misstatements. First, however well-meaning the members of the Hearing Panel may have been, the Panel has stepped well beyond the bounds of its legitimate authority and has gratuitously and impermissibly addressed charges which were not properly before it. Second, the numerous procedural defects which marred both the hearing and the UCEC and CAFT investigations which led up to the hearing have run roughshod over Dr. Kay's federal and state constitutional rights to administrative due process. Moreover, they have seriously and unjustly undermined the fundamental reliability and credibility of the Panel's findings and recommendations. Third, the Panel report fails to discuss, much less analyze, important facts which are directly pertinent to its conclusions regarding scientific misconduct. We remain hopeful that, despite these pervasive errors, you will see fit to set a future course which will bring credit to the University of Arizona and the Board of Regents. I thank you, in advance, for what I am confident will be your careful consideration of the issues catalogued in this letter. 1. PROCEDURAL DEFICIENCIES PRIOR TO COMMENCEMENT OF THE CAFT HEARINGS The Hearing Panel lacked authority to hear any of the charges made against Dr. Kay by the CAFT Prosecutors, which are the subject of the Hearing Panel's May 4threport to you. Because the Hearing Panel clearly lacked jurisdiction to hear these claims, you should reject its findings and recommendations in their entirety. a. The Scientific Misconduct Issues Were Not Properly Before the Hearing Panel. The University's repeated deviations from clearly specified procedural requirements in the handling of its charges of scientific misconduct have so deprived Dr. Kay of her administrative due process rights and have so fatally infected the proceedings that none of the charges pursued were properly before the Panel. Astoundingly, none of the specified charges under the umbrella of CAFT's Charge 1 were ever presented to the UCEC, as expressly mandated by University Handbook for Appointed Personnel 2.13.09. Indeed, the charges of scientific misconduct leveled at Dr. Kay during the hearing were entirely different from those UCEC charges initially presented to, and answered by, Dr. Kay. Furthermore, the UCEC expressly found that the charges originally leveled against her were unsupported by any evidence whatsoever. Thus, the Hearing Panel did not have legitimate authority to entertain the specific charges of scientific misconduct before it. Section 2.13.09 clearly states that any "charges of misconduct may be made by anyone and should be directed, in writing, to the University on Ethics and Commitment (UCEC)." In the instant matter, absolutely none of the specified charges of scientific misconduct considered by the Hearing Panel were ever made to UCEC by a complainant in writing, as expressly required by applicable ABOR rules, nor were the charges initially considered by UCEC documented. Moreover, no such written charges were ever made available to Dr. Kay during the course of the UCEC investigation so that she could properly respond. Section 2.13.09 goes on to require that if written charges are made then "[a] panel of the U.C.E.C. will conduct an inquiry which will consist of information gathering and fact finding to determine whether an allegation of misconduct warrants an investigation and possible sanctions." In the instant matter, the UCEC did not investigate any of the charges which constitute CAFT's Charge 1 before the Hearing Panel, since no written complaint was ever made to begin the investigatory process and since the charges heard March 30 - April 4, 1998 were entirely different from the charges of which Dr. Kay was absolved by UCEC. Furthermore, the Constitution of the General Faculty of the University of Arizona expressly provides, in Article V, Section 7, that "[t]he Committee on Ethics and Commitment shall deal with questions of misconduct in research, scholarship or creative endeavor . . .." (Bylaws and Constitution of the General Faculty of the University of Arizona (Spring 1992), University Handbook for Appointed Personnel, Appendix B, Article V, 7.) Therefore, the authority to investigate such allegations in the first instance lies only with the UCEC. CAFT has no authority whatsoever to initiate new and different charges nor does CAFT have any authority to bring such charges sua sponte. By attempting to usurp the prescribed function of UCEC, by making its own new and different charges when the UCEC found the original charges unsubstantiated, CAFT has not only violated prescribed University procedures, it has also violated well established principles of administrative due process. No one can be legally subjected to the kind of "moving target" investigation which occurred here. Dr. Kay was exonerated by UCEC respecting the original charges, only to be subjected to a totally different set of charges by CAFT, without the opportunity to respond in the fashion dictated by applicable rules and regulations. The procedure established in 2.13.09 of the University Handbook for the handling of charges of misconduct accords the accused at least some degree of due process. By attempting to bring new and different charges without following the proper procedures, CAFT has not only breached the University's regulations and procedures respecting scientific misconduct, but has also trampled Dr. Kay's administrative due process rights. Significantly, an April 15, 1997 letter from UCEC reporting the results of its inquiry to Dr. Michael Cusanovich expressly stated that, as to the allegation of data fabrication, "the inquiry team was unable to find/obtain evidence required to support this allegation." With respect to the second allegation, the letter states, "the inquiry team was presented with no data to support this allegation." In short, UCEC found no probable cause to believe that the charged misconduct ever occurred and, thus, no legal basis for proceeding with the charge. Section 2.13.09, which controls such scientific misconduct inquiries, expressly directs that "[i]f the inquiry has found no reason to think that misconduct has occurred, the Vice President for Research will dismiss the charges and inform all parties in writing." (emphasis added). That is what actually happened, because those charges were dropped by the UCEC. The word "will" is clearly mandatory, not permissive, and the only avenue properly open to Dr. Cusanovich under the circumstances was to dismiss, not rewrite, the charges investigated by UCEC. Moreover, in a letter to Marguerite Kay dated April 23, 1997, Dr. Cusanovich expressly stated, "I am pleased to report that allegations of research fraud or data fabrication against you have not been substantiated." Similarly, in a letter to Mary C. Wetzel, also dated April 23, 1997 (Tab 4), Dr. Cusanovich wrote, "As you will see from the report UCEC did not support the allegations of fabrication of data by Dr Kay . . .." Thus, it is beyond rational dispute that the misconduct allegations originally leveled at Dr. Kay were investigated by the UCEC and clearly found to be without merit. Because of the UCEC's exoneration of Dr. Kay in the area of scientific misconduct, the Hearing Panel was without legal authority to hear new charges of its own and Dr. Cusanovich's making. It is only if a UCEC inquiry leads UCEC to conclude that there is probable cause to believe that misconduct has occurred that "the Vice President for Research must ask the Committee on Academic Freedom and Tenure (C.A.F.T.) to conduct a formal investigation." No such finding was made and the reference of the matter, by the CAFT Prosecutors under the direction of Dr. Cusanovich was wholly improper. b. The University's Scientific Misconduct Investigation Was Seriously Compromised By Its Failure to Promptly Sequester Key Records Wholly aside from the fact that Charge 1 was not properly before the Hearing Panel, the University failed to take appropriate action to secure possession of indispensable evidence relating to that charge, in total violation of federal requirements. Pursuant to the Model Policy for Responding to Allegations of Scientific Misconduct issued by the federal Office of Research Integrity (ORI), after determining that an allegations falls within the definition of misconduct in science and involve Public Health Service funding, the University's Research Integrity Officer must ensure that all original research records and materials relevant to the allegation are "immediately secured." ORI Model Procedures for Responding to Allegations of Scientific Misconduct specify in detail procedures for sequestration of records from the respondent, inventory of the records and security and chain of custody for the records. The University failed totally to timely follow any of these procedures with respect to securing evidence indispensable to a proper determination of the scientific misconduct charges presented to the Hearing Panel. Sequestration of vital contemporaneous records serves a dual purpose. It can help protect one wrongfully accused of scientific misconduct by preserving the documentary record which may absolve the accused. It can also preserve important evidence bearing on whether scientific misconduct has occurred. For this dual reason it is imperative that Universities follow federal policy and procedures regarding sequestration of records. In contrast to the University's failure to take adequate steps to secure pertinent records, Dr. Kay made repeated and increasingly urgent efforts to secure the missing records from her chief accuser, Cathleen Cover, a former lab worker. These efforts commenced even months prior to Dr. Kay's being informed of any allegations of scientific misconduct made against her by Ms. Cover, when in late January 1997, Ms. Cover resigned her employment while Dr. Kay was out-of-state. Despite repeated requests, Cathleen Cover failed to cooperate with Dr. Kay and personally meet with her for a requested check-out, and failed to provide information to Dr. Kay regarding the whereabouts of missing laboratory notebooks. Only after Dr. Kay's repeated urging, did the University's attorney write Cathleen Cover regarding the missing notebooks on March 10, 1997. After being rebuffed by Ms. Cover, the University apparently dropped its efforts to locate the missing data. Given the University's ineffectual efforts to secure pertinent records, no adverse inference could fairly be drawn against Dr. Kay because of any missing records, especially those asserted by her accuser, Cathleen Cover, whose missing lab books were central to the misconduct charges. Nor should charges of scientific misconduct be based on such missing records, since Dr. Kay has been denied access to data which might assist her defense. This failure of proof means that the prosecutors could not make out their case through no fault of Dr. Kay. Thus, it was wholly unfair and improper for the Hearing Panel to draw negative inferences against Dr. Kay on page 2 of its May 4th letter to you, with respect to certain data reported in her Cellular and Molecular Biology article: "The original data for this scattergram are lost. They were apparently in Ms. Cover's laboratory notebooks which 'disappeared' under disputed circumstances," and to state in Appendix 3 to Charge 1, "The raw data have not been provided, and may have been contained in the laboratory notebooks of Ms. Cover that have been reported to be missing. This point and the whereabouts of these missing notebooks were never clearly resolved during the hearing." Since the notebooks were not recovered, there is no evidence of what was actually in the notebooks. Absent evidence, the scattergram is as likely not to have been there as to have been there. If any inferences are to be drawn, they should be drawn in Dr. Kay's favor. We also believe it especially significant that Ms. Cover has a well-established track record for making patently unsubstantiated and untrue allegations against Dr. Kay such as accusations of car theft and artificial self-insemination. Fellow lab worker Doug Johnston documented Ms. Cover's bizarre allegations in a June 5, 1997 note which states in pertinent part, "The following is a list of the things told to me by Cathleen Cover that I believe to be lies: 1.) On 12 March 1997 Cathleen Cover called me at home and told me that her automobile had been stolen and that she believed that Dr. Kay had taken it . . . . 7) Sometime in January 1997 Cathleen Cover told me that she thought that Dr. Kay used various articles used in animal artificial insemination on herself. . . ." (A copy of the June 5, 1997 note is enclosed at Tab 3; see also the affidavit dated March 26, 1997 by Doug Johnston enclosed at Tab 4). Moreover, Ms. Cover currently has litigation pending against the University. We find it incredible that the findings against Dr. Kay involving serious moral turpitude should be based on the slender reed of clearly biased testimony by a disgruntled former employee with limited academic credentials and an established track record of preposterous allegations against Dr. Kay. c. Safety Issues Were Not Properly Before the Hearing Panel And Were All Resolved, And Moot, Well Before The Hearing Charge 2 asserted laboratory violations of a clerical nature, which never resulted in any incident of harm to laboratory personnel and which were remedied by Dr. Kay months prior to the CAFT Investigatory Panel's December 3, 1997, call for a Formal Hearing. Consequently, Charge 2 was moot at the time of the March/April 1998 hearing. The relevant chronology regarding Charge 2 spans a period of some seven months. Initially based on allegations made against Dr. Kay by disgruntled former employee Cathleen Cover, and the allegations of other lab workers, Dr. Michael Cusanovich ordered Dr. Kay on April 23, 1997 to cease all laboratory research involving "the use of human subjects, radioisotopes and biohazards." Prior to Dr. Cusanovich's categorical suspension of Dr. Kay's research on April 23rd, there was no evidence of the University requesting, and not receiving, Dr. Kay's cooperation in remedying cited safety concerns. Indeed, Dr. Kay had glowing audit reports regarding these same activities for which she was shut down. (See, for example, the July 23, 1996 memo from Mary Booth, Radiation Control, to Dr. Kay re: "1996 Audit of Radioactive Materials Approval #436", Exhibit 3K, page 3)(enclosed in our Appendix at Tab 1). Nonetheless, after the April 23rd suspension, Dr. Kay subsequently worked with relevant University committees to correct all noted violations within a matter of months. Consequently, on May 9, 1997, Dr. Cusanovich lifted suspension of Dr. Kay's license to work with radioactive materials. On June 19, 1997, Dr. Cusanovich lifted suspension of human subject activities in Dr. Kay's laboratory. Dr. Cusanovich directed Dr. Kay to comply with a three phase program for lifting of biosafety suspensions. On June 24, 1997, Dr. Cusanovich informed her that she had completed Phase I, on November 5, 1997, that she had completed Phase II, and on November 12, 1997 that she had completed Phase III. As summarized by Dr. Cusanovich in his November 12, 1997 letter to Dr. Kay, "I am pleased to inform you that the biosafety suspension has been lifted, and you are free to proceed with activities requiring biosafety approval. Compliance with inventory, coupled with compliance in the area of radiation safety and human subjects achieved last spring, means that no suspensions are now in place." Assuming that the Hearing Panel was well-intentioned in holding hearings on this moot issue, it is curious that the Panel's May 4th report to you entirely fails to discuss, much less analyze, the evidence in the record that Dr. Kay was deeply concerned about safety, and in important substantive respects practiced safety precautions in excess of standard laboratory practices. (Wyant Declaration, 17-19; Mount, IV HT 287:13-24). Nor does the report discuss the extensive evidence in the record (from highly qualified experts) that Dr. Kay's few errors and omissions reporting record-keeping were of a type common in many active and productive laboratories, and that the shut-down of her laboratory was unprecedented. (Soll Declaration, 35-39; Goodwin, IV HT 143:11-144:9). The Hearing Panel's report is totally inaccurate and misleading in that Appendix 5 reports: "Samples labeled Polio J Virus and Epstein Barr Virus were found. The Hearing Panel was unable to determine whether these substances were in fact present in Dr. Kay's laboratory." The CAFT Panel fails to note, much less analyze, record evidence that: (1)There is no such thing as human or animal virus designated Polio J virus; (2) Dr. David Mount testified that Polio J virus was not an issue; (3) Viral transform cell lines, not Epstein Barr virus were at issue (Mount, IV HT 272:14-276:25); and, (4) Dr. Songer stated that he didn't find anything labeled as pathogens in her laboratory and that he didn't recall seeing anything labeled as Polio J Virus or Epstein-Barr virus. (Songer, V HT 57:4-11). In the final analysis, we believe you would find it most enlightening to speak with Mark Moleski, a Health Physicist with the University's Radiation Control Office, who was intimately involved in investigating alleged safety infractions, participated in site visits to Dr. Kay's laboratory, and is knowledgeable regarding related lab management issues. It is our belief that Mr. Moleski is prepared to state, based on his direct involvement in investigating the safety allegations heard by the Panel, that the safety violations with which Dr. Kay was charged were trivial and without factual basis and that the UCEC's and CAFT's assertions that Dr. Kay's laboratory workers were at risk were a fabrication. d. Lab Management Issues Were Not Properly Before the Hearing Panel The charge regarding Dr. Kay's allegedly deficient lab management practices are simply not within the purview of either UCEC or CAFT. The applicable definition of scientific misconduct does not include management style under the rubric of misconduct. Thus, the UCEC never had the authority to investigate the allegations that were made "regarding commitment and effort where the respondent (Dr. Kay) is seldom on campus or in the laboratory." (April 15, 1997, Letter from UCEC Inquiry Team to Dr. Michael Cusanovich.) The investigation of such management allegations should be solely within the purview of Doctors Marchalonis and Dalen, who are respectively charged with heading the Department of Microbiology and Immunology and the College of Medicine. Review of Dr. Kay's lab management practices could properly have come under scrutiny through either of two mechanisms: (1) as part of her evaluation as a member of the faculty, or (2) in the course of a specific grievance lodged against her. In either case, it is the Department of Microbiology and Immunology and the College of Medicine who, in the first instance, are the proper authorities for handling and investigating lab management issues. Thus, the UCEC did not have the authority to make its determination that there was reason to think such alleged misconduct may have occurred. A fortiori, there was no authority for the Vice President of Research to forward the matter to CAFT pursuant to 2.13.09, since that section does not govern the procedures for handling such an allegation. There was thus no authority for the CAFT panel to hear Charge 5 and forward its recommendations. Evaluation of faculty is governed by ABOR Policy Manual Section 6-211, which specifies proper procedures and emphasizes "the evaluative process should be a localized as possible in order to adapt procedures to individual or departmental circumstances." With respect to grievances, the provisions of Chapter 6 of the Handbook state, "all grievances or complaints by or against appointed personnel shall be filed with and addressed first by the immediate administrative head of the individual about whom the grievance or complaint is made. . . The administrative head shall review the grievance or complaint and develop any factual information required for a decision on the matter." Neither of these procedures were followed in Dr. Kay's case to address Charge 5's issues regarding lab management. Mismanagement allegations should have been presented to Dr. Marchalonis, and that is the point where the investigation should have begun, not with the UCEC. In usurping the proper roles of the Departments and Colleges, and setting itself up as a super-personnel board for the University, the Hearing Panel not only lacked fundamental authority to hear Charge 5 issues or issue recommendations, but unwisely attempts to decide complex managerial and personnel disputes specific to the University's different departments and at a level far removed from the running of those departments. Finally, the hearing panel's artificial time constraints are not conducive to fact-finding and problem resolution in these sorts of complicated issues involving personnel disputes. 2. DR. KAY WAS DENIED HER CONSTITUTIONAL RIGHTS TO ADMINISTRATIVE DUE PROCESS BY PERVASIVE PROCEDURAL DEFECTS DURING HEARINGS CONDUCTED BETWEEN MARCH 30 AND APRIL 4, 1998 The hearings held March 30 - April 4, 1998 were marked by procedural defects which undermined the fundamental fairness of the hearings and the legitimacy of the Hearing Panel's findings and recommendations. First, Dr. Kay labored under artificial and unfair time restrictions in the presentation of her evidence. Second, the CAFT Prosecutors provided all its exhibits to the Hearing Panel, some 20 days prior to the commencement of the proceedings, and thus removed Dr. Kay's ability to object to admission of irrelevant and improper exhibits, as well preventing her right of cross-examination which is a major right recognized by ABOR policy, and the Arizona Administrative Procedures Act. Third, despite its previous consideration of three binders of unauthenticated and unsworn documents sent by the CAFT Prosecutors, as well as an unsworn letter from a secretary in the Tucson area during the hearing, the Hearing Panel refused to accept into evidence sworn declarations from experts offered by Dr. Kay. Fourth, the Hearing Panel refused to receive into evidence deposition transcripts of out-of-state witnesses. Finally, the Hearing Panel refused to allow Dr. Kay representation by counsel during the proceedings. a. The Arbitrary and Restrictive Time Limits Imposed By the University Unfairly Handicapped Dr. Kay And Severely Restricted Her Ability to Adequately Defend Herself The arbitrary time limits imposed by the Hearing Panel operated to the direct and substantial disadvantage of Dr. Kay's defense. Over vigorous protest from Dr. Kay's counsel, the Hearing Panel established an arbitrary time limit of five hearing days to consider this matter, and allotted both sides 15 hours time to both present their own witnesses and cross-examine adverse witnesses. Due to the CAFT Prosecutors putting on their case first with a parade of 20 adverse witnesses -- the majority of which Dr. Kay needed to cross-examine -- the first four hearing days were basically devoted to the CAFT Prosecutors' presentation of the case against Dr. Kay, leaving Dr. Kay approximately one day's time to put on her case and present the testimony of her live witnesses. Thus, due to the rules which skewed the number of days each side had to present its "case in chief," in the roughly four hearing days devoted to CAFT's case, the CAFT Prosecutors were able to present live testimony from 20 witnesses. In contrast, in the one day left to present her case, Dr. Kay was only able to present live testimony from 7 witnesses. There were numerous other witnesses, identified on Dr. Kay's witness list, who could have testified and provided important information in her defense. Moreover, the testimony of Dr. Kay's few witnesses was unduly rushed because of the Hearing Panel's stated intention to shut the hearings down at noon, April 4, 1998. b. The CAFT Prosecutors Provided All Of Their Exhibits Ex-Parte To the Hearing Panel Prior to Commencement of the Hearings, Thus Denying Dr. Kay The Ability To Object To Admission Of Improper And Irrelevant Exhibits Prior to the commencement of the CAFT Hearings, the CAFT Prosecutors provided the Hearing Panel with three full three-inch-thick binders of their hearing exhibits for the Panel's review. This ex-parte provision of exhibits to the Hearing Panel, deprived Dr. Kay of the right to object to highly improper, irrelevant and prejudicial matter (such as documents dealing with a previously settled audit issue under a confidentiality agreement) and to fully and timely seek the exclusion of such materials before it was submitted to, and considered by, the appointed fact finders. This unilateral communication outside the formal hearing process is a violation of well-established principles of administrative due process. (See Gillet v. Arizona Corporation Commission, 121 Ariz. 541, 592 P.2d 375 (Ct. App. 1979, citing Morgan v. United States, 304 U.S. 1 (1938). See also, Corbin v. Arizona Corporation Commission, 143 Ariz. 219, 693 P.2d 362 (Ct.App. 1984). It effectively nullified any control over admission of evidence, such as that provided for in ABOR Policy Manual Section 6-201(L) ("The record of the hearing shall include to the extent any such items are applicable, the following . . . Record of objections and offers of proof and rulings thereon, which may be contained in the transcript."); and ABOR Policy Manual Section 6-201(L)(4)(g)(3) ("The Chair shall preside over and conduct the hearing and shall rule upon all matters of procedure including admission of evidence. . . ."). It also nullified Dr. Kay's right to cross-examination under ABOR Policy Manual Section 6-201(L)(4)(h)(3). In addition, this ex-parte provision of exhibits violates the Arizona Administrative Procedures Act (APA) at 41-1062. As another example of the use of improper, and irrelevant, documentary evidence in the Hearing Panel's Appendix 6, to its May 4th Report, the Panel quotes copiously from a February 10, 1994 letter to Jay Smith, M.D. Vice Dean for Academic Affairs, College of Medicine from Patricia St. Germain, Associate Dean for Administration and Finance and Affirmative Action Officer for the College of Medicine. However, neither Jay Smith, nor Patricia St. Germain ever testified during the hearings, much less were available for cross-examination. Neither were they listed among the CAFT Prosecutors' witnesses. Nor was Dr. Kay's treatment of foreign-born students in 1994 the focus of any charge in these proceedings. Yet this single letter regarding alleged treatment of foreign- born students, is relied upon by the Panel to support a finding of unfilled promises, failure to pay and insulting treatment. Although Dr. Kay had extensive contemporaneous evidence, including letters to her and summaries of meetings that contradicted the statements in the February 10, 1994 letter by Jay Smith, Dr. Kay was never given a chance to present this evidence because of the artificial time limits imposed on her. What is particularly insidious is that the Hearing Panel was exposed to not one, but numerous, improper documents through ex-parte contact, which may well have tainted its deliberations and improperly influenced its findings and recommendations. In addition to bombarding the Hearing Panel with their exhibits before the start of the hearing, the CAFT Prosecutors were also observed engaging in frequent, flagrant, and sustained, ex-parte verbal communication with members of the Hearing Panel throughout the course of the hearing. Lest an attempt be made to excuse such improper ex-parte verbal communication on the basis of faculty "collegiality," it should be noted that the volume of ex-parte verbal communication was markedly one-sided and that Dr. Kay was not accorded the same "collegiality." c. The Hearing Panel Improperly Rejected Dr. Kay's Submission Of Sworn Declarations By Highly Qualified Experts Despite the Hearing Panel's wholesale acceptance of 3 binders of unsworn, unauthenticated exhibits offered by the Prosecutory Panel prior to the commencement of the hearings, and the Hearing Panel's receipt into evidence on April 4, 1998, of an unsworn letter offered by Dr. Thomas Cetas from Vicky McManaham, a Tucson-based Veteran's Administration secretary who had not been called as a witness by the CAFT Prosecutory Panel or cross-examined by Dr. Kay (Cetas, Glittenberg, VI HT 19:8-21), on April 4, 1998, the Hearing Panel refused to admit into evidence two sworn declarations offered by Dr. Kay from noted expert witnesses. The first sworn declaration arbitrarily rejected by the Hearing Panel was from Professor Raymond Wegmann, editor of the journal, Cellular and Molecular Biology, which published one of the three scientific articles challenged by the CAFT Prosecutors. (Kay, Glittenberg, VI HT 20:23-21:16). The second declaration rejected was from Dr. Zaven Khachaturian, a preeminent authority on Alzheimer's Disease and neurodegenerative disorders of the aging. (Glittenberg, Kay VI HT 31:4-34:7). The one-sided treatment accorded the parties -- with every scrap of documentation offered by the CAFT Prosecutors accepted by the Hearing Panel -- and sworn declarations offered by Dr. Kay being rejected by the Hearing Panel -- is indicative of the unbalanced manner in which the proceedings were conducted against Dr. Kay. This greatly erodes the reliability of the hearings as method for determining the facts, and the credibility of the findings and recommendations made by the Hearing Panel. d. The Hearing Panel Wrongfully Rejected Dr. Kay's Submission Of Transcripts and Videotapes of the Depositions of Out-Of-State Witnesses Despite the CAFT Prosecutors being afforded the full opportunity to participate in the out-of-state depositions of both Dr. David Soll and Dr. Timothy Wyant, the Hearing Panel acted in an arbitrary and capricious manner and refused to admit into evidence either witness' deposition testimony because the deposition questions were asked by Dr. Kay's counsel. These depositions were videotaped and the tapes were also offered to the Panel so they could directly view witness demeanor and credibility. Dr. David Soll of the University of Iowa, is a preeminent scientist, runs a large biomedical laboratory involving 12 different areas of expertise, 12 different grants, and 44 researchers and has an independent, informed and objective perspective regarding the charges brought against Dr. Kay. Dr. Timothy Wyant worked under Dr. Kay for a period of some five years and is personally very familiar with her scientific scruples, and her management of her laboratory. Moreover, he was directly responsible for training and supervising laboratory personnel during that period. There is no rationale basis to deny Dr. Kay the ability to introduce the written or videotaped deposition testimony of unavailable witnesses because her counsel, rather than Dr. Kay, asked the questions. The Arizona Administrative Procedures Act (APA) at 41- 1062, specifically provides for representation by counsel and the taking of a deposition of a witness who is unable to attend a hearing. The applicability of APA requirements to CAFT hearings is expressly recognized in the Bylaws of the General Faculty of the University of Arizona, Article IV, Section 9(h): h. Whether formal or informal, a hearing by the Committee or one of its panels shall be conducted according to accepted rules of an administrative fact-finding commission such as those found in applicable sections of the Arizona Administrative Procedures Act. . . " There is no published University authority which specifies that, contrary to the APA, deposition questions of unavailable witnesses, may not be asked by counsel. The Hearing Panel's illogical stance resulted in the Panel refusing to listen to highly credible witnesses convey very salient information. This once more erodes the reliability and credibility of the Hearing Panel's findings and recommendations and underscores the one- sided nature of the proceedings against Dr. Kay. e. The Hearing Panel Improperly Denied Dr. Kay's Right To Be Effectively Represented By Counsel During The Hearings The University's refusal to allow Dr. Kay to be fully and effectively represented by counsel during the hearings also denied Dr. Kay due process rights provided by Article 14, Section 1 of the U.S. Constitution, and Article II, Section 4 of the Arizona Constitution, as well as the Arizona APA. The ample legal authority supporting Dr. Kay's right to counsel is discussed in detail in my March 13, 1998 letter to Jane L. Eikleberry, Esq., the Hearing Panel's counsel (enclosed in our Appendix at Tab 2). When considered in conjunction with the other numerous procedural defects before and during the hearings, the Hearing Panel's refusal to allow Dr. Kay's counsel to represent her during these critical proceedings, appears to be yet another effort to handicap Dr. Kay's defense and crush her efforts to exonerate herself. Refusal to allow either party representation by counsel operates to the distinct disadvantage of Dr. Kay. Dr. Kay is the one charged. Only Dr. Kay could be harmed through these hearings. With everything riding on the result of these hearings -- Dr. Kay's personal and professional reputation, her career in science and her livelihood -- and despite Dr. Kay's lack of familiarity with presentation of evidence and cross-examination, the Hearing Panel required Dr. Kay for five solid hearing days, to single-handedly respond to, and counter, numerous adverse witnesses personally attacking her, and present her own case in chief. Considering the vituperative nature of the charges and the witnesses against Dr. Kay, any nostrums regarding the "independent" and "collegial" nature of these academic proceedings cannot mask the denial of Dr. Kay's basic due process rights or dignify the outcome. 3. CRITICAL FACTS WERE OMITTED FROM THE HEARING PANEL'S REPORT REGARDING SCIENTIFIC MISCONDUCT a. The Challenged Data Are Not Necessary To Establish The Central Premise Of The Challenged Papers. Moreover, There Is No Evidence That The Assigned Errors Are Other Than Honest Mistakes A conspicuous and extremely important omission from the Hearing Panel's findings regarding Charge 1 is evaluation of the three challenged scientific articles using the applicable federal definition of scientific misconduct, codified by the Public Health Service at 42 C.F.R. 50.102. That federal definition of "scientific misconduct" clearly provides that "scientific misconduct . . . does not include honest error or honest differences in interpretations or judgments of data." The University's definition of scientific misconduct in Section 2.13.09 of the University Handbook for Appointed Personnel does not include this basic proviso. In March of 1998 the University affirmed to the federal Office of Research Integrity in its "Annual Report on Possible Research Misconduct" that its procedures comply with applicable Public Health Service regulations, yet to this day, the University remains out of compliance with federal regulations due to its failure to limit its definition of "scientific misconduct" with the vital caveat that "honest error or honest differences in interpretations or judgments of data" are not scientific misconduct. Moreover, as repeatedly stated by the highly qualified experts who testified on Dr. Kay's behalf, none of the challenged data in the three scientific articles in question is necessary to those papers' central premises. Rather, the challenged data is merely additional corroborating information which clearly bears upon, but is totally unnecessary to establishing, the scientific opinions expressed in those papers. The Hearing Panel offers no explanation why Dr. Kay would be motivated to falsify, manipulate or fabricate data of secondary importance, given that Dr. Kay's primary research conclusions are sound and statistically robust. Without any plausible explanation, much less the required "preponderance of the evidence," the Hearing Panel would have you conclude that Dr. Kay, a renown scientist, needlessly jeopardized the credibility of her extensive body of work, by engaging in conscious deception regarding totally extraneous issues. Moreover, the Hearing Panel cites no credible evidence that Dr. Kay purposefully sought to deceive anyone. There is no credible evidence to suggest that any of the papers' errors were anything other than "honest errors or honest differences in interpretations or judgments of data" by Dr. Kay, or errors introduced into the papers, without Dr. Kay's direction and knowledge, by lab employee Jeff Poulin. b. The Hearing Panel's Report Fails To Discuss, Much Less Analyze, The Fact That Dr. Kay's Other Employees Contradicted The Testimony Of Accusers Cathleen Cover And Jeff Poulin, And That Both Cover And Poulin Had Severe Credibility Problems At page 3 of its May 4th letter, the Hearing Panel correctly notes, "Only one individual, Cathleen Cover, testified that Dr. Kay herself explicitly directed her to falsify, manipulate or misrepresent data." However, the Hearing Panel totally fails to discuss or analyze certain facts that go to the inherent credibility of Cathleen Cover's testimony vis a vis the testimony of other witnesses or the testimony of those witnesses. It is therefore important to note that a substantial number of witnesses who worked with Dr. Kay, including those called by the CAFT Prosecutors, testified that they were aware of no data fabrication at the behest of Dr. Kay and moreover, that they had never been asked to falsify, manipulate, or fabricate data for dissemination: Dr. Timothy Wyant (Wyant Declaration, 7), Doug Johnston (Johnston, VI HT 69:17-70:5), Crystal Rockey (Rockey, II HT 222:23-223:21), Dr. Charley Adams (Adams, IV, HT 51:7-20), and Dr. Debra Gamble (Gamble, IV HT 85:21-86:14; 91:23-92:3; 94:1-95:7). Given the numerous witnesses testifying that they were not aware of practices such as those described by Cathleen Cover, the credibility of Ms. Cover becomes of primary importance. What the Hearing Panel fails to acknowledge in its May 4, 1998 report to you is that there are several important reasons why the testimony given by Cathleen Cover is extremely suspect: (1) Ms. Cover is unbalanced as a witness (Ms. Cover has fomented the proceedings against Dr. Kay and pressured other witnesses to support the University's proceedings "to keep from getting in any trouble in the future" or to keep from being investigated by the F.B.I.); (2) Ms. Cover has paranoid thoughts in which she attributes nefarious deeds to Dr. Kay (Ms. Cover has accused Dr. Kay of stealing her car); (3) Ms. Cover is motivated by extreme personal animus against Dr. Kay (Ms. Cover has gone so far to accuse Dr. Kay of sexual abnormalities); and (4) Ms. Cover has made past unfounded accusations against Dr. Kay (such as erroneously accusing Dr. Kay of having accused her of pilfering radioactive materials; and stating that Dr. Kay, rather than Risk Management, required her to clean up the freezer in Building 90 during a controversial incident). I respectfully direct your particular attention to the following documents enclosed in our Appendix which are highly pertinent to the consideration of any testimony given by Cathleen Cover: (1) a memo to the file dated June 5, 1997, by Doug Johnson (Hearing Exhibit 14U, page 2) (Tab 3); (2) an affidavit dated March 26, 1997 by Doug Johnson (Hearing Exhibit 9T) (Tab 4); (3) an affidavit dated March 26, 1997 by Andrew Stephen Noriega (Exhibit B to Dr. Kay's reply memorandum) (Tab 5); (4) a memo to the file dated January 27, 1997 by John Marchalonis regarding Cathleen Cover's misstatements during a conversation with Mark Moleski (Hearing Exhibit 9Q, page 7) (Tab 6). All of these documents have previously been provided to the Hearing Panel for its review during the course of these proceedings. None of these documents, however, were cited or discussed in the Hearing Panel's report to you, thus raising serious questions about the Panel's objectivity. Her penchant for duplicity was well illustrated during the hearing when she admitted that written expressions of "respect and admiration" for Dr. Kay, penned well before the events which gave rise to the hearing, were untrue at the time she wrote them although "it might have been true earlier on in [her] employment." (Cover IV HT 23:17- 26:14). Ms. Cover's credibility is additionally suspect because she is currently prosecuting a self-described "multi-million dollar lawsuit" against the University seeking to recover the cost of treating "pain, discomfort and suffering", as well as wages allegedly lost because of unspecified ailments she claims were contracted when the University "forced" her to clean up allegedly "biohazardous materials" spilled by vandals from University freezers used by Dr. Kay to store research materials. Finally, it must be emphasized that Ms. Cover does not even have a Bachelor's degree and it may well have been Ms. Cover's limited professional experience which led her to conclusions of inappropriate conduct without a true understanding of the data and methods used. In Appendix 3 to its May 4th report, the Hearing Panel attempts to bolster Cathleen Cover's testimony with testimony by Brenda Lara and Dr. Charley Adams. Before addressing the specifics of Ms. Lara's and Dr. Adam's testimony however, it is important to address a general proposition asserted by the Hearing Panel in Appendix 3: "Because witnesses were not allowed to be present prior to their own testimony, these reports appear to be valid, rather than the result of a deliberate collusion between three individuals." This conclusion not reliable because it is based upon incomplete facts. The Hearing Panel's report fails to mention that due to unanticipated delays in the presentation of the CAFT Prosecutors' witnesses, several witnesses who formerly worked for Dr. Kay, waited to testify in the hotel lobby immediately outside the hearing room, and were observed by others, including my staff, conversing freely with those who had previously testified and with members of both the Prosecuting and Hearing Panels. In addition, the testimony of both Jeff Poulin and Cathleen Cover spanned more than one day, and there is nothing to ensure that if they sought to collude, they did not have ample opportunity to discuss testimony prior to the commencement of further questioning. Moreover, my paralegal Stacy Bonacum specifically recalls passing Jeff Poulin in the hotel lobby as he was talking with Cathleen Cover, Dr. Charley Adams and one other woman, and overhearing Jeff Poulin say to the others as she passed by, words to the effect of, "This is what I think they're trying to prove . . . ." In addition, witnesses were permitted to be present during "presentations" given by Margaret Kidwell and Leslie Tolbert as "investigatory witnesses" regarding inquiries into scientific misconduct allegations. (Glittenberg, II HT 104:17-22). Only after the "presentation" portion was completed were witnesses instructed by the Hearing Panel that from that point out, only the witness testifying would be permitted to be present. Accordingly, any witness attending any portion of presentations by Drs. Kidwell or Tolbert were well aware of, and may have received coaching regarding the Prosecuting Panel's scientific misconduct allegations. Thus, while we are not directly aware of collusion, the Hearing Panel's suggestion that there was no opportunity for collusion among the CAFT witnesses is naive and misleading. Contrary to the Hearing Panel's report, Brenda Lara's testimony does not serve to bolster the credibility of Cathleen Cover's testimony. Just as testimony given by Cathleen Cover is inherently suspect, it is inappropriate to bolster the credibility of Ms. Cover's testimony with hearsay statements which Cathleen Cover made to Brenda Lara regarding a phone conversation she had with Dr. Kay, and which were then testified to by Brenda Lara, as cited by the Hearing Panel in Appendix 3 to its May 4th letter. If Ms. Cover is a suspect witness, Ms. Lara's hearsay repetition of past statements made by Cathleen Cover does not increase the reliability of Ms. Cover's statements. Respective of an overheard untruth does not alter its untruthfulness. With respect to the testimony of Dr. Charley Adams, Dr. Adams did not testify that she was present during any conversational exchange between Dr. Kay and Cathleen Cover in which Dr. Kay instructed Ms. Cover to falsify data. Thus, Dr. Adams does not corroborate Cathleen Cover's assertion that Dr. Kay told her to falsify data. It is this portion of Cathleen Cover's testimony which is key to a determination that Dr. Kay instructed others to falsify data, or did so herself. Only Cathleen Cover's highly suspect word stands against Dr. Kay's word, life's work and international reputation. Jeff Poulin's testimony against Dr. Kay also lacks the following credibility because it is dramatically at odds with the testimony of the following witnesses, including 3 then Ph.D. candidates, and 3 CAFT witnesses, who stated that they were unaware of any scientific misconduct in Dr. Kay's laboratory: Dr. Timothy Wyant, Doug Johnston, Crystal Rockey, Dr. Charley Adams, and Dr. Debra Gamble. Jeff Poulin testified that it was "common" that data was dropped to manipulate findings in Dr. Kay's laboratory. Mr. Poulin's testimony was uncritically accepted by the Hearing Panel which referenced it twice: Once without attribution on page 3 of its May 4threport to you, and in once in Appendix 3 to the report. Significantly, the Hearing Panel fails to discuss, much less adequately address, the direct contradiction between this testimony by Jeff Poulin and the unequivocal testimony of 5 other witnesses. Note that this is not an extraneous issue, but goes to the heart of proceedings and Jeff Poulin's credibility. A careful and balanced summary of the hearing evidence would describe that it was emphatically not a common practice to drop data to manipulate findings in Dr. Kay's laboratory. Similarly, on page 6 of Appendix 3, the Hearing Panel uncritically adopts the testimony of Jeff Poulin that "we never had a statistical means of throwing out data or that was taught to use." The Hearing Panel entirely ignores Dr. Kay's query to Jeff Poulin regarding whether he recalled that whenever he asked Dr. Kay about outliers, she said to apply the statistical tests, or if it was more than two standard deviations from the mean, she considered it an outlier and he could discard it; Jeff Poulin responded that he didn't recall. (Kay, Poulin, III HT, 21:2-8). c. The Hearing Panel Fails to Give Adequate Consideration to Key Facts Rebutting The Scientific Misconduct Charges During the course of the hearings it was discovered that even though Dr. Kay never requested Jeff Poulin to drop specific outliers to manipulate findings, Mr. Poulin, who declined to testify under oath (Poulin, II HT 105:3-8)), took it upon himself to drop data because he thought this was expected of him. As he put it, "She didn't specifically say 'drop this number and that number.' I think it was assumed that I could see which one was too extreme and decide that on my own." (Poulin, III HT, 111:15-19). Thus, Mr. Poulin's testimony is totally insufficient to support any finding by the "preponderance of the evidence," or otherwise, that Dr. Kay directed him to engage in the fabrication or falsification of data. As noted by the Hearing Panel in Appendix 3, it is undisputed that Jeff Poulin on one occasion engaged in improper selection of data. However, there is no evidence, much less a "preponderance of the evidence" that Dr. Kay's involvement was anything other than honest error in publishing results based on Mr. Poulin's improperly selected data. Dr. Kay did not find out until some two years after Jeff Poulin left her laboratory that he had manipulated data for the article, Kay and Goodman, Brain and Erythrocyte Anion Transporter Protein, Band 3, as a Marker for Alzheimer's Disease: Structural Changes Detected by Electron Microscopy, Phosphorylation and Antibodies, Gerontology 43:44-66, 1997. At the time she wrote the relevant manuscript, Dr. Kay did not know that the paired analysis, expressed as a ratio, were from a different calculation than the numerical values. The information on the paired analysis was provided in a phone call. (Kay, III HT 12:8-14). Although they shared patients in common, the numerical values were apparently done when only 7 patients had been studied and the paired analysis was performed when 10 patients had been studied. Dr. Kay was not aware of this data selection when she made the table in question for publication. (Kay, III HT 13:2-11). Since Dr. Kay was not aware that the data had been selected, she obviously couldn't comment on it in the manuscript. Dr. Kay accepted the paired analysis data from Jeff Poulin at the time the manuscript was written in early 1996 without going over the original data because she believed Jeff Poulin to be a competent and reliable technician. It was only after Dr. Kay located the original data for the CAFT Hearing, and made it available to the Hearing Panel, that Jeff Poulin's data selection was discovered. It should also be noted that the original CAFT charge was that the paired statistical analysis was not performed. That charge was obviously disproved. On page 4 of Appendix 3, the Hearing Panel commented, "The results of these analyses were introduced by Dr. Kay during her cross-examination of Jeff Poulin, and had not been available to the Investigatory Panel during its previous investigation." This observation is incomplete and misleading. Dr. Kay fully cooperated with both the UCEC and the CAFT Prosecutors in their investigations and provided them with any and all requested records within her possession or under her control. The records showing Jeff Poulin's improper data selection were neither sequestered by the University, nor requested by either the UCEC or the CAFT Prosecutors. It is strong evidence of Dr. Kay's unwitting publication of flawed data that Dr. Kay at the time of the CAFT Hearings readily introduced records showing Jeff Poulin's improper selection of data. Dr. Kay's own bringing to light of records showing improper selection of data is fundamentally inconsistent with the motive of dishonesty and deception which is required for scientific misconduct to exist. With respect to the issue of subordinates, such as Jeff Poulin, engaging in a unilateral decision to improperly drop certain data, Dr. Frederick Goodwin emphasized that inexperienced technicians may erroneously draw inappropriate conclusions from a creative scientist's statement of vision. Dr. Goodwin also made clear, however, that this simply is not sufficient to establish that intentional scientific misconduct has occurred: "Let me say one more thing about your first question and that is just there's lots of gaps between a senior scientist interpretation in this case her own behavior and her own thinking and as you said inexperienced technician about data. There's also a huge risk about taking at face value even well intentioned honest statements by inexperienced statement people, about what particular behavior means. And I'd be very careful about that. Because if somebody -- and here I'm speaking more as a psychiatrist, I guess, if a junior person felt pressure to come up with results, they might interpret Dr. Kay's vision of what she wants, which I think creative scientists do to have. They might interpret that as a tacit instruction to falsify. And I think that's a very tricky area where a person who doesn't have the creative vision is, you know, focusing on the much more right or wrong, black or white, true or false way of looking at data; whereas, a creative scientist is in a different place." Goodwin, IV HT 181:4-24. Dr. Goodwin's testimony has been quoted here at length because the passage selectively quoted on page 3 of the Hearing Panel's May 4th report to you does not fairly convey the full import of Dr. Goodwin's testimony and clearly illustrates the lack of objectivity and fairness which persuades the Panel's submission to you. Please note also that Dr. Paul Coleman's testimony regarding the distinction between "responsibility" and "culpability" is especially pertinent to a just analysis of the evidence. Dr. Coleman is Professor of Neurobiology and Anatomy at the University of Rochester Medical Center, Editor in Chief of the journal Neurobiology of Aging, and runs a laboratory of approximately 15 persons, including graduate students, post doctoral fellows, junior faculty and technicians. Dr. Coleman emphasized that the head of a laboratory, upon learning that there are indications that a graduate student has falsified data, has a responsibility to the scientific community to prevent further dissemination of bad data, however the laboratory head is not culpable if he or she did not engage in a willful act of falsification. (Coleman, VI HT 46:1-10, 54:14-55:19). With respect to Dr. Kay's use of a 2 tailed t-test on replicate samples from the same individual in the paper, Kay and Goodman, Brain and Erythrocyte Anion Transporter Protein, Band 3, as a Marker for Alzheimer's Disease: Structural Changes Detected by Electron Microscopy, Phosphorylation and Antibodies, Gerontology 43:44-66, 1997, the Hearing Panel concluded, "The data appears not to have been fabricated or manipulated." However, the Hearing Panel also stated, "This work constitutes 'scientific misconduct' because it represents a serious deviation from accepted practice in dissemination of results of research." The Hearing Panel's conclusion is in conflict with the testimony of Dr. Stanley Azen, a Professor at the University of Southern California and world class biostatistician, who has authored 2 textbooks and approximately 150 papers on statistical analysis. (Azen, VI HT 128:2-129:8). Even if reasonable scientific and statistical minds could disagree regarding how the methodology was applied and presented, this represents merely "honest error or honest differences in interpretations or judgments of data" not scientific misconduct. The Hearing Panel's report is seriously remiss because it fails to take into account Dr. Azen's testimony. Also with respect to the Gerontology article, the Hearing Panel ignores Figure 3 which appears on page 52, and which shows without "mathematical tools" the raw data on 4 individuals with Alzheimer's Disease (AD) and 4 Controls. The antibody reacts only with the 4 AD and not the 4 Controls. Figure 3 alone makes the point that Dr. Kay made to the Hearing Panel, that there are antibodies that recognize changes in individuals with Alzheimer's Disease. This is, in fact, a major finding of the papers in question. It is important to note, in this context, that the coded samples (Gerontology article, Figure 3 legend, p. 52) used for this study were provided by Dr. T. Saitoh, winner of the Zenith Award for his Alzheimer's Disease work. In addition, Dr. Kay clearly stated in the figure legends that she was presenting, "examples of heterohybridoma antibodies. . . " In Figure 9 at page 56 of Dr. Kay's Gerontology article, and in Figure 5 at pages 930-931 of Dr. Kay's Cellular and Molecular Biology article, antibodies to synthetic peptides are shown binding to AD but not control brain using electron microscopy. These are samples from individuals. With respect to the paper, Poulin, Cover and Kay, "Vitamin E Prevents Oxidative Modifications of Brain and Lymphocyte Band 3 Proteins During Aging," Proc. Natl. Acad. Sci. 93:5600-5603, 1996, contrary to the allusions of the Hearing Panel discussion in Appendix 3, there are no secondary findings. The conclusion of the paper was, "It appears that vitamin E can reduce oxidative damage occurring during aging in at least two of the crucial systems. . ." Given this finding, it is of utmost importance, that regardless of whether the analysis was one on a sample of 53 (selected data) or whether it was done on the unselected data on a sample of 60 (Dr. Kidwell's report), the conclusions resulting from the statistical tests are the same. For the selected data, there was a statistically significant difference between the standard and high vitamin E groups (4.66 v. 8.01, p <0.000002). For the unselected data, there also was a statistically significant difference between the standard and high vitamin E groups (4.76 vs. 6.97, p<0.005). Thus, with or without the unselected data, the conclusions are the same, namely, "It appears that Vitamin E can reduce oxidative damage during aging." The fact that the p-values differ in these two statements is irrelevant, both p values are much less than the traditional cutoff for significance, namely alpha = 0.05. It should also be noted that Dr. Kay did not personally calculate the data herself. Jeff Poulin, first author on the manuscript actually calculated the data (Poulin, III HT 5:12-16, 6:19-7:1, 20:11-16)) and drew the tables and figures for the manuscript. These data were published as presented to Dr. Kay by the papers' principal author, Jeff Poulin. Moreover, Dr. Kay gave proofs of the manuscript to all authors for their review and correction before publication and incorporated any suggestions they had into the final manuscript which, in turn, was scrutinized by the publisher. The Hearing Panel on page 7 of Appendix 3, also incorrectly states the Vitamin E paper's main finding. The paper did not claim, "enhancement of anion transport," the impression noted was preservation of anion transport. Since "intent" is central to the examination of whether scientific misconduct has occurred, the key witness whose testimony you should consider is Dr. Kay. To that end, our appendix includes selected portions of testimony given by Dr. Kay during her presentation of her case (Kay, V HT 107:1-152:3) (enclosed in the Appendix at Tab 7). We strongly believe that a careful review of Dr. Kay's description of the content and purposes of the three challenged articles makes clear beyond rational dispute that CAFT has committed a gross injustice against a dedicated scientist and researcher in its patent misstatement of the premises of the papers in question and the conclusions suggested by Dr. Kay. A prime example of the Hearing Panel's incomplete and misleading report to you is shown by page 2, lines 5-8 of Appendix 3, where the Hearing Panel quotes only selected portions of Dr. Kay's testimony and summarily attributes malfeasance to Dr. Kay: "When Dr. Kay was testifying regarding the data in Figure 7, (Volume V, p. 144) she stated 'when I wrote this, did I believe there were 19 patients? Yes. I was told there were 19 patients in (and) control' then she goes on to say "does it matter that there are six and these are quadruplicates? No. . . the paper is still publishable.' Based on this response and many others she expressed during the hearing, it is apparent that Dr. Kay does not adhere to the basic tenant [sic] that complete honesty in publishing data is required. It appears to be her opinion that if manipulated values make a point more graphically they are still publishable." In fact, Dr. Kay's full hearing testimony actually indicates exactly the opposite of what the Hearing Panel would have you believe: "Now, a lot has been made about this figure. Well, those of you who have drawn diagrams, if you want to make points look very tight, I would go with arrow bars. What I wanted to do, the purpose of presenting data like this is to show what range. It's better to show ranges in individual points. "When I wrote this, did I believe there were 19 patients. Yes. I was told there were 19 patients [and] in control[s]. Does it matter to the purpose of this manuscript that there are six and these are quadruplicates. No. I could have done better in describing what I did. That wasn't the function I saw of the manuscript. I wish I had and I certainly would put "N" and the number and so on. "The paper is still publishable. Does it change the way I feel about it? No. The way I feel? No. This figure shows overlap. This doesn't reduce overlap. Look. There is overlap there. I am trying to deliberately show people there is overlap. Does that change anything? No. Look at this range. It goes from 340 to 944 control. It goes from what about 640 to about 1140 for the Alzheimer's. "I certainly wouldn't say I was reducing overlap. I wouldn't say that was a tight range. I deliberately used a scattergram so that people could see the range. The point in fact is there is a wide range for normal and Alzheimer's. That's a point. That's why I showed it that way. "I did not instruct anyone to manipulate the data in this. I could put more points in anywhere in here and still publish this. I can remove this graph from the paper and it won't change the paper or the conclusions, and it won't change the acceptance anywhere. It doesn't matter. I did not manipulate the data either. I at the time did not know how to use the programs. I don't use staff [stat] view. "My only instructions to Cathleen were she came to me with a scattergram with control and Alzheimer's mixed all up together, so there all over the page. And I asked her to separate them so that they would be easy to read instead of a bunch of dots. If you can imagine triangles and circles all over. I suggested that she line them up one on the left and one on the right. Those were my instructions. They're for readability." (Kay, V HT 143:19-145:17). Also enclosed in our Appendix, for your review, are copies of letters written to me from experts in Dr. Kay's field, commenting on the quality and importance of the challenged papers appearing in the journals of Gerontology and Cellular and Molecular Biology (letter dated March 25, 1998 from Dr. Joseph R. Goodman to Robert K. Wrede (Tab 8); letter dated March 26, 1998 from Dr. Gieljan Bosman to Robert K. Wrede (Tab 9)). The roving, and misguided nature of the scientific misconduct charges made against Dr. Kay is also well illustrated by the CAFT Prosecutors' data fabrication allegation regarding the Vitamin E paper's references to "young" mice data. Although the CAFT Prosecutors alleged that experiments on young mice had not been performed, the Hearing Panel found that "Raw data from the 'young' group of mice were present in Jeff Poulin's laboratory notebooks." Had the University properly fulfilled its responsibilities to sequester relevant records, and met its other investigatory obligations, this specious charge would never have advanced to the Hearing Panel for resolution. Whether based on the peevish and unsupported accusations of disgruntled ex-employees, or the unfounded speculation of the CAFT Prosecutors, such a charge is indicative of the improper treatment accorded to Dr. Kay throughout these proceedings. In summary of the examples supporting CAFT's Charge 1, the Panel states at page 3 of its May 4th report, ". . . Dr. Kay, through her personal conduct, may have given others in her laboratory the message that experiments 'had to come out right.'" In addition to the conditional phrasing of this sentence -- which itself indicates conjecture, rather than evidence -- no facts are provided in the Hearing Panel's letter describing any conduct which proves the required motive to support a specific charge of scientific misconduct. Moreover, since that scientific misconduct does not include "honest error or honest differences in interpretations or judgments of data" the Hearing Panel's complaints regarding the disorganization, lack of quality control and receipt of multiple data sets doesn't support a finding of scientific misconduct. d. CAFT Charges Dr. Kay With Practices Common In Other Scientific Papers, Including Papers Authored By Dr. Leslie Tolbert And Dr. Thomas Davis, None Of Which Constitute Scientific Misconduct Please note that the very practices which the Hearing Panel characterized as scientific misconduct in Dr. Kay's papers occur repeatedly in publications authored by others involved in the CAFT proceedings, such as Dr. Leslie Tolbert and Dr. Thomas Davis. See, for example: (i) Baumann, Oland, & Tolbert, Glial Cells Stabilize Axonal Protoglomeruli in the Developing Olfactory Lobe of the Moth Manduca sexta, The Journal of Comparative Neurology, 373:118-128, 1996; (ii) Krull, Morton, Faissner, Schachner, & Tolbert, Spatiotemporal Pattern of Expression of Tenascin-Like Molecules in a Developing Insect Olfactory System, Journal of Neurobiology, 25:515-534, 1994; (iii) Thomas, Abbruscato, Hruby & Davis, The Entry of [D-Penicillamine 2,5] Enkephalin into the Central Nervous System: Saturation Kinetics and Specificity, The Journal of Pharmacology and Experimental Therapeutics, 280:1235-1240, 1997; (iv) Mania-Farnell, Botros, Day & Davis, Differential Modulation of Prohormone Convertase mRNA by Second Messenger Activators in Two Cholecystokinin Producing Cell Lines, Peptides, 17:47-54, 1996; (v) Williams, Abbruscato, Hruby, and Davis, "Passage of a b-Opioid Receptor Selective Enkephalin, [D-Penicillamine 2,5] Enkephalin, Across the Blood-Brain and the Blood-Cerebrospinal Fluid Barriers,Journal of Neurochemistry, 66: 1289-1299, 1996; (vi) Thomas, Abbruscato, Hau, Gillespie, Zsigo, Hruby & Davis, Structure-Activity Relationships of a Series of [D-Ala 2] Deltorphin I and II Analogues; in Vitro Blood-Brain Barrier Permeability and Stability, The Journal of Pharmacology and Experimental Therapeutics, 281: 817-825, 1997; and (vii) Abbruscato, Thomas, Hruby & Davis, Blood-Brain Barrier Permeability and Bioavailability of a Highly Potent and u-Selective Opioid Receptor Antagonist, CTAP; Comparison with Morphine, The Journal of Pharmacology and Experimental Therapeutics, 280:402-409, 1997. Copies of these articles are enclosed in our Appendix for your reference at Tab 10. Simply to illustrate this point, it is highly instructive that, in the papers listed above, Dr. Tolbert expressed certain conclusions about development of the insect olfactory system using microscopy, and in some cases, immunoreactivity in a fashion which would be subject to the very same criticisms the Hearing panel has leveled at Dr. Kay. Nowhere in her papers, for example, does she state the number (n) of individuals, sample size, nor does she state how many times she does the experiment. We know that she had 1 individual and did the experiment once because she shows a single micrograph. In contrast, if one counts "visible" individuals that one can "see" in blots and micrographs, Dr. Kay obviously did her study on at least 5 different AD and 5 different normals based on Figures 3 and 5 in her challenged article appearing in Gerontology. These 10 individuals were from different labs. Moreover, Dr. Saitoh's 7 individuals in Figure 3 were from a totally different patient population. In another example, on page 518 of Dr. Tolbert's article in the Journal of Neurobiology, Dr. Tolbert states, "For a few experiments . . ." This implies she did more than one, but she doesn't indicate how many. Similarly, in Figure 6 of Dr. Tolbert's Journal of Neurobiology paper, she presents a "immunoreactivity profile," but she does not give "n," the number of replicates, the number of times the experiment was performed, nor does she present any statistical data. Dr. Kay makes statements such as "There is a significant difference in binding to AD and control brains by a number of antibodies to band 3 including those to Ad-Bd3, COOH which recognizes peptide breakdown products of band 3 [40](fig. 5), . . . " (Gerontology article, p. 52), thus using a reference to anther paper as evidence. Dr. Tolbert repeats this practice frequently in her papers. See, for example, Dr. Tolbert's article in the Journal of Comparative Neurology at page 123 (1st line of results section), and her article in the Journal of Neurobiology article, at page 521. The reference to which Dr. Kay refers in her challenged Gerontology article, ref 40, shows one of her antibodies to a synthetic peptide giving triples or doublets reactions in 10/10 AD and singlet reactions in 5/6 Normal controls in Western blots in Dr. Saitoh's laboratory (Figure 2) and by immunohistochemistry (Figure 3 A-D). This is a presentation of results from at least 18 individuals. This work was done in Dr. Saitoh's laboratory with antibodies provided by Dr. Kay. This evidence was presented in detail to the CAFT panels. I enclose for your reference, Saitoh, Masliah, Baum, Sundsmo, Flanagan, Vikramkumar, & Kay, "Degradation of Proteins in the Membrane-Cytoskeleton Complex in Alzheimer's Disease -- Might Amyloidongenic APP Processing Be Just the Tip of the Iceberg?, Annals of the New York Academy of Sciences, 647:180-191 (1992) (enclosed in our Appendix at Tab 11). Another Hearing Panel objection is to Dr. Kay's presentation of "examples from single individuals as "misleading," with reference to Figures 6 and 7 of Dr. Kay's Gerontology article, even though Dr. Kay presented numerous examples from numerous individuals showing similar results to the Hearing Panel. This is accepted practice. Dr. Tolbert, in her article in The Journal of Comparative Neurology, at page 124, states, "Figure 3B illustrates the most typical finding . . ." Although Dr. Tolbert does not state the results are from a single insect, it has to be because it is a single micrograph. Dr. Davis, in Figure 1, at page 820 of above-cited 1997 article appearing in The Journal of Pharmacology and Experimental Therapeutics, by Thomas, Abbruscato, Hau, Gillespie, Zsigo, Hruby and Davis, states, "An example . . . " This is taken to mean that there are other such graphs, but he is simply showing one of them. It implies one experiment, individual, or one whatever. The Hearing Panel states at page 2 of its May 4th letter report to you, "Drawing inferences from measures on single individuals represents a serious deviation from accepted practices in disseminating results of research." However, Dr. Tolbert (as do many, many others, we hasten to add) does this all the time, and therefore, it appears to be accepted practice. Dr. Tolbert infers active, fluid cellular processes during development from static micrographs of a single individual. Contrary to the Hearing Panel Report, Dr. Kay did not draw inferences from single individuals; she drew inferences from multiple individuals done as single experiments with one patient and one control in a pairwise fashion. Dr. Kay explained to the Hearing Panel that in her challenged paper appearing in the journal of Cellular and Molecular Biology, the antibodies questioned were tested by 4 different methods. Thus, the findings taken together support the finding that she has some (more than one) antibodies that distinguish Alzheimer's Disease from normal. Dr. Tolbert makes a similar argument on page 127, (first page of Summary), of the above-cited article appearing in The Journal of Comparative Neurology, "Taken together, the results of the current experiments point to the last of the three models. . ." It is the weight of all of the evidence taken from four different methodologies that supports Dr. Kay's scientific opinions. This was clearly explained to the Hearing Panel in Dr. Kay's explanation of the overview of the papers. (Kay, V HT 112:14-118:11, 134:11-23). Regarding Dr. Kay's alleged "failure" to provide number (n) of individuals, this is a standard procedure. Dr. Tolbert does not provide numbers in any of her papers in the Materials and Methods section or in the figure legends. In addition, in 4 papers in which Dr. Thomas Davis, Chair of the UCEC, is senior author and respected Regents Professor Dr. Victor Hruby, is a co-author, the number of animals is not given in the Materials and Methods sections or in many of the figure legends. (See Abbruscato, et al., Blood-Brain Barrier Permeability and Bioavailability of a Highly Potent and u-Selective Opioid Receptor Antagonist, CTAP; Comparison with Morphine, The Journal of Pharmacology and Experimental Therapeutics, 1997.; Thomas, Abbruscato, et al., Structure-Activity Relationships of a Series of [D-Ala 2] Deltorphin I and II Analogues; in Vitro Blood-Brain Barrier Permeability and Stability, The Journal of Pharmacology and Experimental Therapeutics, 1997; and particularly, Thomas, Abbruscato, Hruby & Davis, The Entry of [D- Penicillamine 2,5] Enkephalin into the Central Nervous System: Saturation Kinetics and Specificity, The Journal of Pharmacology and Experimental Therapeutics, 1997; and Williams, et al., "Passage of a b-Opioid Receptor Selective Enkephalin, [D-Penicillamine 2,5] Enkephalin, Across the Blood-Brain and the Blood-Cerebrospinal Fluid Barriers, Journal of Neurochemistry, 1996 (Figure 3 and Table 3). In some figures, n is given as 3-7. Following the Hearing Panel's logic, the statement is misleading because it implies that all points are 7 mice and that 7 mice are used in all figures and time points even though a specific number is not given. It would have been misleading if Dr. Kay had said in the figure legend that she used 10 patients when she had only used 1. But she said "an example. . . . " clearly indicating to readers that she was alluding to only one example. Moreover, even a "misleading" statement, if the result of honest error or differences, does not constitute the "fabrication" or "falsification" of data required for a finding of "scientific misconduct." This simply did not occur. Furthermore, it appears that the "n=3" in figure legends in some of the papers by Dr. Davis refers to triplicate samples rather than 3 individuals. (Thomas, Abbruscato, et al., Structure-Activity Relationships of a Series of [D-Ala 2] Deltorphin I and II Analogues; in Vitro Blood-Brain Barrier Permeability and Stability, The Journal of Pharmacology and Experimental Therapeutics, 1997). This appears to be the case because the assay was done on brain homogenates (presumably made from multiple animals, but never stated) and/or primary cultures of brain homogenates although the paper is unclear on this point, and the error bars are very tight -- too tight to be multiple individuals. Thus, contrary to the Hearing Panel Report, performing statistical analysis on replicate samples is accepted procedure and indicating "n" for the number of replicates is also accepted. Dr. Kay did not mislead her scientific audience because she did not state anynumber of individuals. The Hearing Panel chose to "infer" what Dr. Kay intended. The more probable inference would have been to assume that Dr. was studying single individuals. (See the enclosed letter dated March 25, 1998 from Dr. Joseph R. Goodman to Robert K. Wrede (enclosed in our Appendix at Tab 8); letter dated March 26, 1998 from Dr. Gieljan Bosman to Robert K. Wrede) (enclosed in our Appendix at Tab 9). In the above-cited paper by Mania-Farnell et al., appearing in Peptides, 1996, on which Dr. Davis is senior author, it is not stated in the Materials and Methods section, what the number of experiments are, although an "n" is given in most of the figure legends. The authors are treating cell cultures. Therefore, "n" is not the number of people or mice. On page 49 of that article, Figure 2 states, "n=4" or "n=5" at several places in the legend, but is this the number of times the experiment was performed, the number of cell cultures treated, or is it a replicate of the same samples? On page 48 in the Materials and Methods section, the article states, "Treatments were done in duplicate for each individual experiment." This is certainly vague and confusing, but it isn't scientific misconduct. The same is true for other figures such as Figures 3, 4 and 6. It appears to be accepted practice. N is a number, but the authors define what the number represents (cells, individuals, replicates, experiments, etc), or in the case just cited, do not define what it is. On page 7 of Appendix 3, the Hearing Panel faults Dr. Kay for showing only the probability value and failing to show the data in data set #4. This is standard practice. Prosecutory Panel member Dr. Tolbert often makes similar statements without showing the data. See, for example, page 526 of the above-cited paper appearing in the Journal of Neurobiology, 1994. This is standard practice in journals with strict, short page limits such as the Proceedings of the National Academy of Sciences, in which Dr. Kay's challenged paper appeared. In Thomas, Abbruscato, Hruby & Davis, The Entry of [D-Penicillamine 2,5] Enkephalin into the Central Nervous System: Saturation Kinetics and Specificity, The Journal of Pharmacology and Experimental Therapeutics, 1997, data from a previous paper (Williams, et al., 1996) is included in Table 2 on page 1238, only this time it is presented in tabular form rather than as a figure. This is an original article. Dr. Kay was faulted for doing a similar thing in the review article appearing in Cellular and Molecular Biology. The point is that the omissions of which Dr. Kay stands accused appear in many other papers by many scientists, including those authored by some of her accusers. They do not constitute scientific misconduct. Dr. Kay claimed that her graphs were examples, not multiple individuals. The Hearing Panel asserted that Dr. Kay was making claims about multiple individuals, not Dr. Kay. The Hearing Panel's criticism of "vague statements," "scientific misrepresentations," "sloppiness," etc. could be said of the selected publications described above and any random sampling of papers from the University. But vagueness, sloppiness and inadvertent misrepresentations, no matter how egregious, do not constitute scientific misconduct. Moreover, it is of fundamental importance that none of the asserted omissions by Dr. Kay's data presentation change any of her papers' conclusions. The Hearing Panel's complaint that they can't tell what was done from the description implies that excruciating details of data collection and statistical handling should be provided in each paper challenged. While this may be accepted and usual practice for papers published in statistical journals, it is simply not the case for biomedical papers and reviews. As an example, in Dr. Davis' papers, he has a section on "statistics" wherein he states what statistical tests were performed, but not the details of how the biological sample analysis was handled (e.g. as replicates, numbers of experiments, cultures, animals). Dr. Tolbert does not include any such information in her papers. Obviously, detailed statistical information is not the "accepted standard" in biological papers. The antibodies being questioned by CAFT have been tested by 4 different methods. Thus, Dr. Kay was not observing the artifact of a technique. If she had tested 1000 patients by a single technique there would be a question of whether she was studying an artifact of a technique. Instead, confidence was gained in the results by testing a small number of patients by 4 techniques. This study was to determine whether it was possible for an antibody to distinguish between Alzheimer's and controls, not to produce a finished product. Dr. Kay was testing the antibodies, not the patients. She was selecting the few positive antibodies from a large sample to screen extensively later in the study. 4. CAFT'S CHALLENGES TO DR. KAY'S COMPETENCE AS A REGENTS PROFESSOR ARE COMPLETELY AT VARIANCE WITH THE INDEPENDENT FINDINGS OF AN ELECTED DEPARTMENTAL REVIEW COMMITTEE WHICH HAS RANKED DR. KAY AS OUTSTANDING IN TEACHING, RESEARCH AND SERVICE FOR THE PAST THREE YEARS It is striking that an elected departmental Performance and Evaluation Committee reviewing faculty for the last three years (1995/1996, 1996/1997, and 1997/1998) ranked Dr. Kay "outstanding" in the categories of teaching, research and service, and numerically ranked her as one of the top two faculty members overall. Because the irreconcilable inconsistency between the repeated findings of her colleagues respecting her competence, and the findings of CAFT as both prosecutor and trier of Dr. Kay are so stark, I have attached a copy of the May 26, 1998 letter from Dr. John Marchalonis to Dr. James Dalen. Great weight must be given to the knowledgeable deliberations of this Committee which was not subject to the pressure and tremendous volume of ex-parte communication experienced by the members of the Hearing Panel. I also emphasize that this duly elected faculty review committee reviewed Dr. Kay and others according to post-tenure review criteria as recommended by ABOR. The enormous disparity between the University faculty's recent overall evaluation of Dr. Kay for the past three years, and the Hearing Panel's Report is yet another important indication of the inherent unreliability of the Hearing Panel's findings. With respect to any of the charges against Dr. Kay, in the event you wish to review the detail which was provided in Dr. Kay's Opening Statement, and Closing and Reply Memoranda submitted to the Hearing Panel, I have also enclosed these documents for your review in our Appendix at Tabs 12 through 14. I note, in closing, that the expert witnesses Dr. Kay presented were, with the exception of Dr. Paul Coleman, individuals with whom Dr. Kay had neither prior friendship nor acquaintance. The willingness of professionals of national and international stature to involve themselves in these University of Arizona proceedings on her behalf underscores the merit of Dr. Kay's position and the serious errors made by CAFT, both in its procedural and in its adjudicative roles. Accordingly, enclosed for your review at Tab 15 of our Appendix are the C.V.s of: Dr. Frederick Goodwin, Dr. David Soll, Dr. Zaven Khachaturian, Dr. Stanley Azen, and Dr. Paul Coleman. In addition, in our Appendix, I enclose copies of testimony of Dr. Frederick Goodwin (Tab 16), Dr. Stanley Azen (Tab 17), and Dr. Paul Coleman (Tab 18), as well as the Declarations of Dr. David Soll (Tab 19), Dr. Zaven Khachaturian (Tab 20), and Professor Raymond Wegmann (Tab 21). Because of the pervasive error which has infected the University's handling of this matter from the outset, and the abject failure of those charging Dr. Kay with scientific or any other kind of misconduct to provide substantial evidence to support those charges, we respectfully request that you reject the findings and recommendations of the Hearing Panel in their entirety. I'm sure you are painfully aware that, as president of the University, you stand as the institutional "court of last resort" in the instant proceedings. It is you who must weigh the testimony of several clearly disgruntled youngsters of questionable credibility against the seasoned, clearly unbiased testimony of exceptionally qualified experts - none of whom found any evidence whatsoever of "scientific misconduct" by Dr. Kay. Any fair reading of the three papers at which CAFT has taken umbrage clearly reveals that the basic scientific opinions expressed in those papers remain valid to this day and really represent the visionary perspective of a highly respected and productive physician/scientist on what the future of biomedical science may hold in store for our species in an area of critical personal and social importance - the diseases of aging. I express no opinion as to what or who drove the UCEC/CAFT process to its current unfortunate state. I am reminded, however, of an adage my father repeated to me throughout my youth and young adulthood, which I think is especially pertinent here: "The road to hell is paved with good intentions." Only you can prevent the instant proceedings, however well-intended, from concluding in a fashion which will irreparably suppress and discourage the adventurous curiosity which drives research of the nature which, for so many years, has characterized the incredibly productive, innovative, and invaluable work of Marguerite Kay, and the work of those like her. We would be happy to answer any questions you may have about the proceedings against Dr. Kay either in writing or in person, as you see fit. Very truly yours, Robert K. Wrede, of PARKER, MILLIKEN, CLARK, O'HARA & SAMUELIAN |
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