1 NO. 90-CI-6033 JEFFERSON CIRCUIT COURT DIVISION ONE (1) 2 3 JOYCE FENTRESS, ET AL. PLAINTIFFS 4 5 VS. DEPOSITION FOR PLAINTIFFS 6 7 SHEA COMMUNICATIONS, ET AL. DEFENDANTS 8 * * * * * * * * * * 9 10 DEPONENT: VICKI THOMPSON 11 DATE: AUGUST 18, 1993 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 20 (502) 589-2273 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * 13 NO. 92-14775-E 14 RICHARD HAROLD CROSSETT, JR., ) IN THE 15 CHAD H. CROSSETT, AMY MICHELLE ) DISTRICT CROSSETT AND KRISTEN ANN CROSSETT, ) COURT OF 16 INDIVIDUALLY AND AS SURVIVORS OF ) AND ON BEHALF OF THE ESTATE OF ) 17 JOCQUETTA ANN CROSSETT, DECEASED ) ) 18 V. ) DALLAS COUNTY, ) TEXAS 19 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, TEXAS ) 20 PSYCHIATRIC COMPANY, INC. ) D/B/A/ HCA WILLOW PARK ) 101ST JUDICIAL 21 HOSPITAL, JAMES K. WITSCHY, M.D., ) DISTRICT AND DOUG BELLAMY, ED.D. ) Page 2 1 * * * * * * * * * * 2 NO. A-921,405-C 3 MARIA GUADALUPE REVES ) IN THE 4 INDIVIDUALLY AND AS NEXT ) DISTRICT COURT FRIEND OF GRANT JULIAN REVES ) OF 5 A MINOR CHILD, AND ON BEHALF ) OF THE ESTATE OF CHRISTIAN ) 6 MARIE REVES, DECEASED ) ) ORANGE COUNTY, 7 V. ) TEXAS ) 8 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, RAVIKUMAR ) 9 KANNEGANTI, M.D., HOSPITAL ) CORPORATION OF AMERICA, A ) 10 TENNESSEE CORPORATION, HEALTH ) SERVICES ACQUISITION CORP., ) 11 A DELAWARE CORPORATION, ) HCA PSYCHIATRIC COMPANY, A ) 12 DELAWARE CORPORATION, TEXAS ) PSYCHIATRIC CO., INC.. A/K/A ) 13 AND/OR D/B/A HCA BEAUMONT ) NEUROLOGICAL HOSPITAL, AND HCA ) 14 HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL A/K/A AND/OR BEAUMONT ) DISTRICT 15 NEUROLOGICAL HOSPITAL ) 16 * * * * * * * * * * Page 3 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION 3 ELIZABETH T. SANCHEZ, ) 4 INDIVIDUALLY AND AS THE ) SURVIVING SPOUSE, MARGARET R. ) 5 SANCHEZ, INDIVIDUALLY AND NEXT ) OF FRIEND OF DEBRA JEAN ) 6 SANCHEZ, VERONICA MARIE ) SANCHEZ, EDWARDO ESTEBAN ) 7 SANCHEZ, AND MICHAEL ANTHONY ) SANCHEZ, CHILDREN; AND ALL ON ) 8 BEHALF OF THE ESTATE OF ) EDWARDO SANCHEZ ) 9 ) V. ) CIVIL ACTION NO. 10 ) SA93CA367 ELI LILLY AND COMPANY AND ) 11 DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS 14 HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) AND AS NEXT FRIEND OF DEBORAH ) 16 SANCHEZ, VERONICA SANCHEZ, ) EDDIE SANCHEZ, AND MICHAEL ) 17 SANCHEZ, AND ON BEHALF OF THE ) ESTATE OF EDUARDO SANCHEZ ) 18 ) V. ) CIVIL ACTION NO. 19 ) H-93-1469 ELI LILLY AND COMPANY AND ) 20 DISTA PRODUCTS COMPANY, A ) DIVISION OF ELI LILLY AND ) 21 COMPANY ) Page 4 1 * * * * * * * * * * 2 STATE OF NEW YORK 3 SUPREME COURT COUNTY OF JEFFERSON 4 _____________________________________________ 5 STEPHANIE CAPONE, AS EXECUTOR OF THE ESTATE OF JOSEPH J. CAPONE, JR., AND 6 STEPHANIE CAPONE, INDIVIDUALL, NOTICE TO TAKE 7 PLAINTIFF, DEPOSITION UPON ORAL EXAMINATION 8 VS. INDEX NO. 93-251 9 ELI LILLY AND COMPANY, DISTA PRODUCTS 10 COMPANY, A DIVISION OF ELI LILLY AND COMPANY, FLOYD BAJJALY, M.D, 11 DEFENDANTS. 12 _____________________________________________ 13 * * * * * * * * * * 14 SUPREME COURT OF TEH STATE OF NEW YORK COUNTY OF ORANGE 15 --------------------------------------X BRUCE R. MALEN AS EXECUTOR OF THE : INDEX NO. 16 ESTATE OF BARBARA E. MALEN, AND OF : 4119/92 BRUCE R. MALEN, INDIVIDUALLY, : 17 : HON. PETER PLAINTIFF : PATSALOS, 18 : J.S.C. -against- : 19 : ELI LILLY & COMPANY, DISTA PRODUCTS : 20 COMPANY, A DIVISION OF ELI LILLY & : COMPANY, BARRY SINGER AND UNITED : 21 HOSPITAL, : : 22 DEFENDANTS. : --------------------------------------X 23 * * * * * * * * * * Page 5 1 ---------------------------------X 2 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 3 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 4 : DOCKET NO. : L-3191-91 5 VS. : : 6 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 7 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 8 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 9 : DEFENDANTS. : 10 ---------------------------------X 11 * * * * * * * * * * 12 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 13 -------------------------------------x 14 RHOMDA L. HALA and JOSEPH L. HALA, : 15 Plaintiffs, : Index No. 14869/90 16 - against - : 17 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 18 ELI LILLY & COMPANY : 19 Defendants. : -------------------------------------x 20 21 * * * * * * * * * * Page 6 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 PATRICIA BRACH, ) ) 4 Plaintiff ) ) 5 v. )No. 92 L 13369 ) 6 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 7 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 8 ) Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 11 COUNTY DEPARTMENT - LAW DIVISION 12 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 13 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 14 ) Plaintiff, ) 15 ) v. ) No. 91 L 7881 16 ) ROBERT L. NELSON, et al., ) 17 ) Defendants, ) 18 ) GEORGE MELNICK, M.D. and PETER ) 19 FINK, M.D. ) ) 20 Respondents in Discovery.) 21 * * * * * * * * * * Page 7 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 JOAN M. GRYER, ) ) 4 Plaintiff, ) ) 5 v. ) No. 92 L 7387 ) 6 ELI LILLY AND COMPANY, et al., ) ) 7 Defendants. ) 8 * * * * * * * * * * 9 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 10 COUNTY DEPARTMENT, LAW DIVISION 11 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 12 HAMMERLI, a disabled person, ) ) 13 Plaintiff, ) ) 14 v. ) No. 92 L 2365 ) 15 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 16 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 17 Respondent in Discovery), ) ) 18 Defendants. ) 19 * * * * * * * * * * Page 8 1 IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT 2 CHAMPAIGN COUNTY, ILLINOIS 3 LINDA GARDNER, Individually and ) as Special Administrator of ) 4 the Estate of SHANE GARDNER, ) deceased, ) 5 ) Plaintiff, ) 6 ) v. ) No. 91 L 1066 7 ) ELI LILLY AND COMPANY, a foreign ) 8 corporation, ) ) 9 Defendant. ) 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT 12 LAKE COUNTY, ILLINOIS 13 JAMES E. SHEPPARD, Special ) Administrator of the Estate of ) 14 KENNETH K. SHEPPARD, Deceased, ) ) 15 Plaintiff ) ) 16 v. ) No. 93 L 124 ) 17 GOOD SHEPHERD HOSPITAL, a ) corporation, DR. STEWART SEGAL, ) 18 DR. SANFORD SHERMAN, DR. BRUCE ) CARLSON, DR. R. BERGLUND, and ELI ) 19 LILLY & COMPANY, a corporation, ) ) 20 Defendants. ) 21 * * * * * * * * * * Page 9 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * Page 10 1 THE DEPOSITION OF VICKI THOMPSON, TAKEN AT 2 THE OFFICE OF BAKER & DANIELS, 300 NORTH MERIDIAN 3 STREET, SUITE 2700, INDIANAPOLIS, INDIANA 46204, 4 ON AUGUST 18, 1993; SAID DEPOSITION TAKEN 5 PURSUANT TO NOTICE IN ACCORDANCE WITH THE RULES 6 OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 PAUL SMITH COUNSEL FOR PLAINTIFFS 14 745 CAMPBELL CENTER 2 8115 NORTH CENTRAL EXPRESSWAY 15 DALLAS, TEXAS 75206 16 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 17 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 18 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 19 MR. HARRINGTON 20 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 21 INDIANAPOLIS, INDIANA 46285 Page 11 1 DENISE BRODSKY 2 COUNSEL FOR GOOD SHEPHERD HOSPITAL 415 WASHINGTON STREET, SUITE 214 3 WAUKEGAN, ILLINOIS 4 MIGUEL A. RUIZ COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA 5 CLAUSEN MILLER GORMAN CAFFREY & WITOUS 10 SOUTH LASALLE 6 CHICAGO, ILLINOIS 60603 7 PAUL J. CLEMENTI COUNSEL FOR DR. DICKIE KAY 8 HINSHAW & CULBERTSON 222 NORTH LA SALLE STREET, SUITE 300 9 CHICAGO, ILLINOIS 60601-1081 10 KATHERINE L. LAWS COUNSEL FOR DRS. WITSCHY AND KANNEGANTI 11 BAILEY AND WILLIAMS 3500 NCNB PLAZA 12 901 MAIN STREET DALLAS, TEXAS 75202-3714 13 Page 12 1 I N D E X 2 3 DEPOSITION OF VICKI THOMPSON 4 5 DIRECT EXAMINATION BY MS. ZETTER.........14 6 CROSS EXAMINATION BY MR. SMITH..........153 REDIRECT EXAMINATION BY MS. ZETTLER.....203 7 CROSS EXAMINATION BY MS. LAWS...........253 CERTIFICATE.............................255 8 ERRATA..................................256 9 EXHIBITS 10 PLAINTIFFS' EXHIBIT NO. 1...............138 11 PLAINTIFFS' EXHIBIT NO. 2...............208 PLAINTIFFS' EXHIBIT NO. 3...............215 12 PLAINTIFFS' EXHIBIT NO. 4...............223 PLAINTIFFS' EXHIBIT NO. 5...............228 13 PLAINTIFFS' EXHIBIT NO. 6...............231 PLAINTIFFS' EXHIBIT NO. 7...............239 14 Page 13 1 COMES VICKI LEE THOMPSON, CALLED 2 BY THE PLAINTIFF, AND AFTER FIRST BEING DULY 3 SWORN, WAS DEPOSED AND TESTIFIED AS FOLLOWS: 4 DIRECT EXAMINATION 5 BY MS. ZETTLER: 6 Q. Could you state your full name 7 for the record? 8 A. My name is Vicki Lee Thompson. 9 Q. Is it Vicki or Victoria? 10 A. Vicki, V-I-C-K-I. 11 MS. ZETTLER: Let the record reflect 12 that this is the discovery deposition of Vicki 13 Thompson taken pursuant to notice in the 14 applicable state and local rules of Kentucky. 15 Q. Miss Thompson, my name is Nancy 16 Zettler and I represent a number of plaintiffs in 17 the Fentress versus Shea Communications case, and 18 lots of it stems from the shootings at Standard 19 Gravure by Joseph Wesbecker back in September of 20 1989. 21 MS. LAWS: Just to make our record 22 clear, we have been reserving objections on 23 issues except as to the form of the question and 24 responsiveness of the answer and the objection of Page 14 1 one defense counsel has been good as to all; is 2 that still our agreement? 3 MR. MYERS: That is, and, of course, 4 understanding there is some objections to the 5 deposition has been noticed in the MDL 6 proceedings and in a number of related state 7 cases. 8 Q. (BY MS. ZETTLER) Have you 9 given a deposition before? 10 A. No. 11 Q. Let me explain to you some of 12 the ground rules. 13 First of all, do you prefer to 14 be called Ms., Mrs., Miss, Doctor? 15 A. Miss is fine. 16 Q. Do you have a Ph.D or M.D. or 17 anything? 18 A. No, I have a M.S. 19 Q. Let me give you ground rules of 20 depositions so that hopefully it will go a little 21 smoother. The first ground rule is that you have 22 to answer out loud, you can't shake your head or 23 go uh-huh because she can't take that down, okay? 24 Also, if we could both try, and sometimes it get Page 15 1 hard especially towards the end of the day, not 2 to talk over each other, in other words let me 3 finish my question, and I will do my best to let 4 you finish your answer so she can take it down, 5 okay? 6 A. Yes. 7 Q. And if you don't understand any 8 of my questions or any of the other questions 9 that the lawyers ask you, please let us know and 10 we will rephrase it. If you answer the question, 11 we are going to assume that you understood it, is 12 that fair? 13 A. Yes. 14 Q. If at any time you want to take 15 a break, let us know and we'll take a break. 16 A. Yes. 17 Q. What's your date of birth? 18 A. November 17, 1948. 19 Q. And your social security 20 number? 21 A. xxxxxxxxxxx. 22 Q. And your current address? 23 A. xxxxxxxxxxxxxxxxxxxxxxxxxxxx 24 xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx. Page 16 1 xxxxx. 2 Q. And you're currently employed 3 at Eli Lilly and Company? 4 A. Yes. 5 Q. When did you start working for 6 Lilly? 7 A. June of 1989. 8 Q. Have you worked there 9 continuously till the present? 10 A. Yes. 11 Q. Could you give us an idea of 12 your education and background starting with after 13 high school? 14 A. After high school I have an 15 A.S. degree from Indiana University in Nursing,. 16 I have a B.S. degree from Marion College in 17 Nursing, and I have a masters degree in 18 psychiatric nursing from Indiana University. 19 Q. Okay. I'm sorry, was that 20 Marion College? 21 A. Uh-huh. 22 MR. MYERS: Yes. 23 A. Yes. 24 MS. ZETTLER: It's human nature, we'll Page 17 1 remind you. 2 Q. When did you get your A.S. 3 degree at Indiana University? 4 A. 1978. 5 Q. How about your B.S. at Marion? 6 A. I don't know, I believe it was 7 1981. 8 Q. And your Masters? 9 A. 1985. 10 Q. So I take it you didn't go 11 straight through from undergraduate to your 12 masters? 13 A. No, I didn't. 14 Q. And you told us your Masters is 15 in psychiatric nursing, correct? 16 A. Yes. 17 Q. Did you have -- did you take 18 any courses that stressed psychiatric nursing 19 when you were receiving your B.S.? 20 A. Yes. 21 Q. Were you an R.N. after your 22 B.S.? 23 A. I was an R.N. after my A.S., 24 after I passed the state board. Page 18 1 Q. When you were studying for your 2 A.S, did you specialize in psychiatric nursing 3 also? 4 A. No. 5 Q. That was a general course? 6 A. Yes. 7 Q. Can you give me an idea of what 8 types of classes you took when you were working 9 towards your bachelors, the psychiatric courses, 10 nursing courses? 11 A. Psychiatric nursing courses 12 when I was getting my bachelors was a psychiatric 13 mental health nursing, and clinical component to 14 that. 15 Q. Anything else? 16 A. Not directly related to 17 psychiatric nursing. 18 Q. When you say a clinical 19 component, is that you actually do clinical work, 20 in other words work with patients? 21 A. Yes, supervised work. 22 Q. You were supervised by either 23 another registered nurse or somebody like a 24 psychiatrist or psychologist? Page 19 1 A. By faculty from Marion College 2 and by a registered nurse at the community mental 3 health center and the state hospital. 4 Q. How about your masters, give me 5 an idea of some of the psychiatric specific 6 courses you took during that -- 7 A. I took psychopharmacology, 8 individual therapy, group therapy, family 9 therapy, statistics and research, theory, I also 10 had a clinical component to that in both 11 individual, family and group. 12 Q. Okay. Anything else? 13 A. Psychiatric consultation. 14 Q. Okay. Any others? 15 A. Not that I can recall. 16 Q. When you say therapy, what do 17 you mean, do you mean like participating in 18 therapy as a treater? 19 A. Yes, providing therapy. 20 Q. And stats and research, give me 21 an idea of what those courses were about other 22 than the obvious. 23 A. The research was the types of 24 research methodology, the different theories in Page 20 1 research, the statistical course was a graduate 2 level statistics. 3 Q. Did the research courses on 4 types of research methodology include clinical 5 trials, trials run in psychopharmacology? 6 A. No. 7 Q. Was that more in the lines of 8 research with regards to disease processes, 9 things of that nature? 10 A. No, what that was in line with 11 was the types of double blind research, this is 12 what this is, this is what a single blind 13 research is. 14 Q. So it was describing that, it 15 was more of a general drug trial type of course? 16 A. No, it had nothing to do with 17 drug trials. 18 Q. Give me a general idea how a 19 double blind study would relate to something 20 other than a drug trial? We are just trying to 21 get an idea what the context was. 22 A. A double blind study can be 23 done on an evaluation therapy where you are 24 looking at what process causes what outcome and Page 21 1 you have a group of patients that you use the 2 process with and another group of patients that 3 you don't use the process with and that's your 4 control. 5 Q. Okay. Did you write a thesis 6 for your Masters? 7 A. Yes, I did. 8 Q. What was the subject? 9 A. The subject was the effects of 10 group psychotherapy on chronically 11 psychiatrically disturbed patients. 12 Q. Was that a particular mental 13 illness that you focused in on or was it like a 14 general -- in other words depression, bipolar, 15 schizophrenia, did you cover a bunch of different 16 diseases or just concentrate on one? 17 A. I covered a bunch of different 18 diseases but it was chronic patients, meaning it 19 had lasted -- their diseases had lasted over one 20 year. 21 Q. At any time as part of your 22 education did you participate in any clinical 23 trials on psychiatric drugs? 24 A. No. Page 22 1 MR. MYERS: When you say participate, I 2 assume you mean as a -- 3 MS. ZETTLER: Not as a volunteer 4 patient. 5 MR. MYERS: Thank you. 6 Q. Then, of course if you did, we 7 would like to know that too. Let's talk about 8 your employment prior to Lilly, when did you 9 graduate from high school? 10 A. In 1967. 11 Q. What did you do between high 12 school and going back to school to get your 13 associates? 14 A. I worked as a bookkeeper for 15 Robert Hall Clothes, I was a homemaker. 16 Q. Did you work in the psychiatric 17 field at all during that period of time? 18 A. No. 19 Q. Did you work in the medical 20 field at all? 21 A. No. 22 Q. Anything that would relate to 23 drug manufacturing or clinical trials and drugs? 24 A. No. Page 23 1 Q. Throughout the course of you 2 obtaining your associates, did you work? 3 A. Yes, I worked in summers. 4 Q. What did you do during the 5 summer? 6 A. I worked as a student nurse at 7 Marion General Hospital. 8 Q. Is that a full-time or 9 part-time position? 10 A. It was full-time in the 11 summers. 12 Q. Did you work with the 13 psychiatric patients? 14 A. No. 15 Q. Is that general nursing? 16 A. It was general nursing, I had 17 dementia patients were part of that general 18 nursing. 19 Q. What did you do with the 20 dementia patients? 21 A. Provided nursing care. 22 Q. Anything psychiatric specific? 23 A. No. 24 Q. How many summers did you work Page 24 1 at Marion General? 2 A. One. 3 Q. During that summer, did you 4 work with any patients who were suffering from 5 depression to your knowledge? 6 A. Not to my knowledge. 7 Q. Any other jobs during that 8 period of time when you were working towards your 9 associates? 10 A. No. 11 Q. How about when you were working 12 towards your bachelors, did you work during that 13 period of time? 14 A. Yes, I did. 15 Q. Where did you work? 16 A. I worked at Marion General 17 Hospital Coronary Care Unit. 18 Q. Was that again during the 19 summers? 20 A. No, that was a period of five 21 years between my associate and my B.S.N., the 22 period of time between my associate and B.S.N. I 23 worked as full-time night shift. On my last year 24 of that period, I worked at General Motors as an Page 25 1 industrial nurse, part-time. 2 Q. When you worked at Marion 3 General for the second period of time, was that 4 strictly coronary care? 5 A. Yes, I would float at times 6 when need be in emergency room and in ICU. 7 Q. When you say that you worked at 8 Marion General in Coronary Care from the period 9 of time between the associates, is that obtaining 10 your bachelors or starting to work toward your 11 bachelors? 12 A. That was starting to work and 13 obtaining it, the last year when I was doing 14 clinical courses, the last year is when I was 15 working part-time. 16 Q. Do you recall what year you 17 started working in coronary care? 18 A. 1978. 19 Q. For approximately five years, 20 right? I am talking about not the first time 21 when you worked as a student nurse, the second 22 time when you worked at Marion. 23 A. It was from the time that I 24 finished my A.S. degree to the time I finished my Page 26 1 B.S. in nursing degree. 2 Q. After working at Marion General 3 in coronary care and GM, where did you work next? 4 A. I worked for Marion Community 5 School Systems, I was an instructor for the 6 licensed practical nurse program. 7 Q. What kinds of courses did you 8 teach? 9 A. I taught pediatric courses, I 10 did teach psychiatric courses. 11 Q. So you did -- 12 A. Yes. And I taught beginning 13 general nursing courses. 14 Q. Tell me about the psych courses 15 that you taught? 16 A. It was a general introduction 17 to psych geared towards LPN practical nursing 18 students. 19 Q. Anything specific to working 20 with patients suffering from depression? 21 A. Yes -- well, the details of the 22 disease, concept of depression. 23 Q. Where did you gain your 24 knowledge of the details and disease concept of Page 27 1 depression? 2 A. From my B.S. course in 3 psychiatric nursing and from my clinical 4 expertise. 5 Q. When you say your clinical 6 expertise, you mean the clinical courses that you 7 took in college? 8 A. Yes. 9 Q. Where did you work after the 10 Marion Community School System? 11 A. After the Marion Community 12 School System, I came to IU and enrolled in the 13 Masters program and worked part-time on Six North 14 psychiatry at Indiana University Hospital, a 15 tertiary care -- 16 Q. I'm sorry, you were going to 17 say it was a tertiary care hospital for the IU 18 Medical Center? 19 A. Tertiary care hospital at IU 20 Medical Center. 21 Q. Is that a full-time or 22 part-time position? 23 A. It was a part-time position. 24 Q. Was that direct patient care? Page 28 1 A. Yes. 2 Q. Tell me generally what kinds of 3 care you would render to the psych patients at 4 Indiana University Hospital? 5 A. Provide one to one therapy, I 6 administered psychiatric medications, I observed 7 patients. 8 Q. Anything else? 9 A. We would take them on different 10 field trips, see how they would function socially 11 and worked with families. 12 Q. Families of patients? 13 A. Yes. 14 Q. How long did you work at 15 Indiana University Hospital? 16 A. Two years. 17 Q. Do you recall, would that have 18 been starting in about 1983? 19 A. Yes. 20 Q. Did you administer any Prozac 21 or Fluoxetine to any of the patients that you 22 cared for? 23 A. No, I didn't. 24 Q. Did you participate with the Page 29 1 same caveats as before on any clinical trials on 2 Fluoxetine? 3 A. No, I didn't. 4 Q. Prior to being formally 5 employed by Eli Lilly, have you ever participated 6 in any way in clinical trials on Fluoxetine? 7 A. No. 8 Q. Okay. After working at Indiana 9 University, where did you work? 10 A. I went to Bloomington 11 Convalescent Center and worked as assistant 12 director of nursing for one year until 13 Bloomington Stress Care Center opened and then I 14 was employed at Bloomington Hospital Stress Care 15 Center. 16 Q. In your position as assistant 17 director of nursing at Bloomington Convalescent, 18 did you have any responsibilities related 19 directly to patient care? 20 A. No. 21 Q. I'm sorry, the next one was 22 Bloomington Stress Center? 23 A. Yes. 24 Q. And that was associated with Page 30 1 the hospital? 2 A. Yes. 3 Q. Which hospital? 4 A. Bloomington Hospital, both 5 Bloomington Convalescent Center and the Stress 6 Care Center were associated with Bloomington 7 Hospital. 8 Q. What did you do in the stress 9 center? 10 A. I was charge nurse day shift. 11 Q. I'm sorry? 12 A. Charge nurse day shift. 13 Q. Did that position entail direct 14 patient care responsibilities? 15 A. Yes, it did. 16 Q. Were those limited to 17 psychiatric patients? 18 A. Limited to psychiatric 19 patients. 20 Q. What were your responsibilities 21 with regards to patient care and stress? 22 A. Planning patient care, 23 developing patient care plans, providing one to 24 one therapy, providing family and group therapy, Page 31 1 administering psychiatric medications. 2 Q. When you say providing therapy, 3 do you mean as a psychotherapist? 4 A. My masters degree is a therapy 5 degree, it's a practice degree. 6 Q. Are you -- 7 A. So it's practicing psychiatric 8 nursing on a graduate level. 9 Q. Are you a licensed therapist? 10 A. No. 11 Q. Is the therapy that you render 12 considered psychotherapy? 13 A. It's considered counseling. 14 Q. Okay. Are you a licensed 15 counselor? 16 A. No, but my degree allows me to 17 practice. 18 Q. In the course of your 19 experience with counseling, have you talked to 20 patients who are suffering from depression? 21 A. Yes. 22 Q. On how many occasions, if you 23 know? 24 A. I can't recall, I can't give Page 32 1 you a number. 2 Q. More than fifty? 3 A. I can't recall. 4 Q. Would part of your counseling 5 of patients suffering from depression include 6 medication monitoring? 7 A. Yes. 8 Q. Tell me about that, what would 9 you do to monitor the medication? 10 A. What you would do is you would 11 assess side effects of the medication, you would 12 take vital signs, you would assess whether or not 13 the medicine was being advantageous. 14 Q. Anything else? 15 A. No. 16 Q. Did you work under the 17 supervision of a psychiatrist or another M.D.? 18 A. Yes. 19 MR. MYERS: With the Bloomington 20 Stress? 21 MS. ZETTLER: At any time that she was 22 monitoring medications. 23 A. Yes. 24 Q. Was there ever an occasion Page 33 1 where you recommended to the psychiatrist that 2 was supervising you with a particular patient 3 that that patient be taken off an anti-depressant 4 or any other medication? 5 A. Not that I can recall. 6 Q. What were some of the side 7 effects that you would list people on 8 anti-depressants suffering from? 9 A. Dry mouth, constipation, 10 drowsiness, heart palpitations, difficulty 11 urinating. 12 Q. I'm sorry, dry mouth, 13 constipation -- 14 A. Heart palpitations, difficulty 15 urinating. 16 Q. Any nervous system side 17 effects? 18 A. Not that I can recall. 19 Q. Any psychiatric side effects? 20 MR. MYERS: What do you mean by that? 21 MS. ZETTLER: Anything that might be 22 termed as anything that might be considered 23 something that isn't necessarily physiologically 24 based. Page 34 1 A. No. 2 Q. Okay. After working at the 3 stress center, where did you work? 4 A. I went to IU, Indiana 5 University. 6 Q. And what did you do there? 7 A. I taught psychiatric nursing. 8 Q. When did you start at Indiana 9 University teaching? 10 A. 1988. 11 Q. Is that a full-time position? 12 A. Yes, it was. 13 Q. And tell me a little bit about 14 the courses that you taught? 15 A. Psychiatric nursing courses so 16 I taught theory, I taught psychotropic 17 medications, and I supervised students at 18 Methodist Hospital in an acute psychiatric ward, 19 teaching them clinical nursing skills. 20 Q. Do you have a background in 21 psychopharmacology? 22 MR. MYERS: What do you mean by that? 23 MS. ZETTLER: Specific. 24 Q. Did you take a specific course Page 35 1 of training in pharmacology or psychopharmacology 2 throughout your experience, your educational 3 experience in nursing? 4 A. Yes, in my masters degree I 5 took a specific course. 6 Q. What did that course entail? 7 A. It was a very detailed course 8 and it entailed learning the neuro chemistry of 9 the brain, learning how specific psychotropic 10 medications were acted, what we knew about how 11 they act, learning about the side effects of 12 specific medications. 13 Q. During that course, you took 14 psychopharmacology in your masters program, did 15 you study serotonin re-uptake inhibitors? 16 A. No. 17 Q. When you taught a psychiatric 18 medication course as part of the psych nursing 19 courses that you taught at Indiana University, 20 did you teach regarding serotonin re-uptake 21 inhibitors? 22 A. Yes, I did. 23 Q. Where did you gain your 24 knowledge as the to the action of serotonin Page 36 1 re-uptake inhibitors? 2 A. From what's known in the 3 literature. Subsequent to my class, I gained my 4 knowledge from getting printouts from pharmacists 5 that come from the large data base that tells 6 what is known about serotonin re-uptake 7 inhibitors. 8 Q. Would that be the DAWN data, 9 D-A-W-N? 10 A. I don't know that the DAWN data 11 was part of the data base where I collected my 12 information. I was given the printout by the 13 pharmacist so I don't know where it came from. 14 It was the printout that the pharmacist used at 15 Methodist Hospital. 16 Q. Tell me a little bit more about 17 the printout, what kind of information is 18 contained in the printout? 19 A. The types of information that 20 is contained in the printout was everything that 21 was known about selected serotonin re-uptake 22 inhibitors based on clinical trials. 23 Q. So it was information that they 24 received from Eli Lilly? Page 37 1 A. Yes. 2 Q. Is this something that's done 3 with every drug? 4 A. Yes. 5 Q. Is this something that's just 6 done specifically to this hospital or is this 7 something that hospitals ascribe to? 8 A. I don't know. 9 Q. Do you recall ever seeing like 10 a company name or, you know, a company that would 11 gather the information? 12 A. No, I don't recall that. 13 Q. Have you kept any of those 14 printouts? 15 A. No, I haven't. 16 Q. Did you ask for printouts on 17 medications other than Fluoxetine from the 18 pharmacist at the hospital? 19 A. Yes, I did. 20 Q. What other drugs if you can 21 think of them? 22 A. Thorazine, Haldol, specifically 23 drugs that I wanted to know more about because it 24 was a detailed printout. Page 38 1 Q. Was the printout in a narrative 2 form? 3 A. Yes. 4 Q. Did it give statistics? 5 A. I don't recall. 6 Q. Do you recall about 7 approximately how long the Fluoxetine printout 8 was? 9 A. There were two pages to the 10 Fluoxetine printout. 11 Q. Was it broken down into 12 categories like side effects, adverse events, 13 things of that nature? 14 A. I don't recall. 15 Q. To your knowledge, was 16 Fluoxetine approved for the use in treating 17 depression at that time? 18 MR. MYERS: What time? 19 MS. ZETTLER: In 1988 when she started 20 teaching nursing at Indiana University. 21 A. Yes, the end part of that year, 22 yes. 23 Q. The end of 1988? 24 A. Yes. Page 39 1 Q. And generally what did you -- 2 well, what did you teach your students about side 3 effects of Fluoxetine at that time? 4 A. I told them what was noted in 5 the product insert as being adverse events noted 6 in the clinical trials of the drug. 7 Q. Okay, give me an idea of what 8 was noted in the insert as adverse events? 9 A. Headache, nausea, insomnia. 10 Q. Was nervousness listed? 11 A. I don't recall. 12 Q. How about anxiety? 13 A. I don't recall. 14 Q. How long did you teach at 15 Indiana University? 16 A. One year. 17 MR. SMITH: How long? 18 A. One year. 19 Q. You started at Lilly in June of 20 1989, right? 21 A. Yes. 22 Q. At any time prior to that date, 23 that month, June of 1989, did you administer 24 Fluoxetine to any patient whatsoever? Page 40 1 A. Yes. 2 Q. Where? 3 A. Bloomington Stress Center. 4 Q. When did you work at 5 Bloomington Stress Center again, I'm sorry? 6 A. It was '87 to '88. 7 Q. Just prior to going to Indiana 8 University? 9 A. Yes, just prior to that. 10 Q. And on how many occasions did 11 you administer Fluoxetine to patients at the 12 stress center? 13 A. I can't recall at all. 14 Q. More than once? 15 A. Yes. 16 Q. More than ten times? 17 A. Yes. 18 Q. How about more than fifty 19 times? 20 A. I can't recall. 21 Q. When I say administer, I mean 22 different patients, not administering the drug to 23 one patient for five days in a row, is your 24 answer the same? Page 41 1 A. My answer is the same, I can't 2 recall. 3 Q. When you administered the 4 Fluoxetine to these patients at the stress 5 center, had Prozac already been approved for use 6 in depression? 7 A. Yes, otherwise I wouldn't have 8 been administering it. 9 Q. You didn't administer it to 10 anybody at the stress center in relation to a 11 clinical trial, did you? 12 A. No, I did not. 13 Q. What side effects did you 14 observe in those patients that were on 15 Fluoxetine? 16 A. I don't remember. 17 Q. Were these all inpatients? 18 A. Yes. 19 Q. Okay. After your teaching 20 position at Indiana University, where did you 21 work next? 22 A. Eli Lilly and Company. 23 Q. How did you come to be employed 24 at Lilly? Page 42 1 A. I was interested in the 2 clinical trial process, I was interested in 3 research and I applied at Eli Lilly and was 4 hired. 5 Q. Did you approach them or did 6 they approach you first? 7 A. I approached them. 8 Q. Who did you interview with at 9 Lilly? 10 A. I interviewed with Bill Dunn, 11 Mike Noone, Ardith Heiber, I believe it's 12 E-I-B-E-R, but it could be I-E-B-E-R. 13 Q. And what was his first name? 14 A. Ardith, A-R-D-I-T-H, it's a 15 she. 16 Q. Anybody else? 17 A. There were more people, I don't 18 recall their names. 19 Q. What position were you 20 interviewing with, or for, I'm sorry? 21 A. I was interviewing for a 22 clinical research administrator position. 23 Q. Did you specifically ask to 24 interview for that position or did you ask to Page 43 1 interview for whatever was available? 2 A. I asked to interview for a 3 position where I would be in contact with 4 research. I wasn't aware of the CRA position 5 prior to interviewing. 6 Q. Were there other positions 7 available at that time besides the CRA position? 8 A. I have no idea. 9 Q. When you interviewed with these 10 various people, Bill Dunn, Mike Noone and Ardith 11 Heiber, did they explain to you what a CRA did or 12 what the responsibilities would be? 13 A. Yes, they did. 14 Q. What did they tell you? 15 A. They told me what the 16 responsibilities were for the administrative 17 aspect of the clinical trial process. 18 Q. Which included what? 19 A. I don't remember their exact 20 words. 21 Q. How about generally? 22 A. I don't remember from then what 23 they told me. 24 Q. Okay. I take it you were hired Page 44 1 for the CRA position? 2 A. Yes, I was. 3 Q. What is your position now? 4 A. I'm a department head. 5 Q. What department? 6 A. Neurosciences. 7 Q. Nurse sciences? 8 A. Neurosciences. 9 Q. And how long were you a CRA? 10 A. I was a CRA from June of 1989 11 until October of 1992. 12 Q. What division or department did 13 you work in as a CRA? 14 A. As a CRA, I worked in the 15 psychopharmacology area. 16 Q. Is that part of the medical 17 division? 18 A. Yes, it is. 19 Q. Did you work in any other areas 20 besides psychopharmacology when you were a CRA? 21 A. No. 22 Q. What were your responsibilities 23 as a CRA when you were hired in June of 1989? 24 A. Responsibilities with Page 45 1 monitoring clinical trials, the administrative 2 aspects of clinical trials. 3 Q. As opposed to the medical 4 aspects of the clinical trials? 5 A. Yes. 6 Q. What did that entail, what 7 administrative duties did you have? 8 A. Administrative duties were 9 talking with investigators and study coordinators 10 at investigative sites, to discuss various 11 aspects of the protocol, to provide clinical 12 trial materials to the sites, to review case 13 report forms when they came in from the sites, to 14 field questions from study coordinators, 15 investigators, to monitor the adverse drug 16 experiences that were coming in from the sites, 17 to submit form 1639 to the FDA, to help 18 participate in final study reports. 19 Q. Did you have any writing 20 responsibilities? 21 MR. MYERS: What do you mean by 22 writing? 23 MS. ZETTLER: Writing the final 24 reports, writing protocols, writing manuscripts, Page 46 1 anything. 2 A. I participated in the group 3 that did that, yes. It wasn't my sole 4 responsibility. 5 Q. When you say you participated 6 in the group that did that, what group are you 7 talking? 8 A. The group of Lilly personnel 9 that were responsible for writing manuscripts and 10 for writing final reports. It was more than me 11 alone. 12 Q. How many manuscripts did you 13 participate in writing? 14 A. During that period of time? 15 Q. Let me ask you this, did your 16 responsibilities as a CRA change at any time from 17 June of 1989 through October of 1992? 18 A. My responsibilities didn't 19 change. 20 Q. Generally the same stuff you 21 just told me about? 22 A. Yes. 23 Q. During that period of time, 24 June of '89 through October of '92, was there Page 47 1 ever a period of time where you worked 2 exclusively on Fluoxetine? 3 A. Yes. 4 Q. What period of time? 5 A. From June of '89 until it was 6 approximately June of '92, I can't remember the 7 exact date. 8 Q. Okay. When you originally 9 interviewed for the CRA position, did any of 10 those people that you interviewed with tell you 11 that you would be working exclusively with 12 Fluoxetine? 13 A. No. 14 Q. So when you told me earlier 15 that you were responsible for monitoring the 16 administrative aspects of clinical trials, those 17 were all clinical trials that were being 18 conducted on Fluoxetine? 19 A. Yes. 20 Q. Did you work on any depression 21 clinical trials? 22 A. No, I did not. 23 Q. Have you ever worked on any 24 depression trials? Page 48 1 A. No, I have not. 2 Q. When I say depression, I mean 3 Fluoxetine use with people suffering from 4 depression? 5 A. No, I have not. 6 Q. Did you work on trials being 7 done for other indicated uses of Fluoxetine such 8 as like bulimia, obesity, OCD? 9 A. Yes. 10 Q. Which indicated uses? 11 A. Bulimia. 12 MR. SMITH: Beg your pardon? 13 THE WITNESS: Bulimia nervosa. 14 Q. Anything else? 15 A. I've helped with final reports 16 for OCD indication and I helped with final 17 reports for obesity indication and that's all. 18 Q. To your knowledge, have any of 19 these other indications been given FDA approval? 20 A. To my knowledge they have not 21 been. 22 Q. Was any of these indications 23 given preliminary and advisory committee 24 approval? Page 49 1 MR. MYERS: OCD has. 2 Q. Did you participate in the 3 preparation of manuscripts or final reports 4 related to the use of Fluoxetine in depression? 5 A. Yes. 6 Q. Which reports -- let's start 7 with reports? 8 A. No final reports. 9 Q. Okay. How about manuscripts? 10 A. Yes. 11 Q. Which ones? 12 A. Meta-analysis manuscript. 13 Q. Okay. Any others? 14 A. That's all. Related to 15 depression? 16 Q. Right. 17 A. That's all. 18 Q. That's the manuscript that was 19 eventually published in the British Medical 20 Journal? 21 A. Yes, it is. 22 Q. And you were listed as a 23 secondary author on that paper? 24 A. Yes, I was. Page 50 1 Q. Was that paper ever published 2 in any other magazine or journal or publication? 3 A. Not to my knowledge. 4 Q. How about any other Fluoxetine 5 related manuscripts, did you participate in the 6 preparation of any? 7 A. Yes. 8 Q. Which ones? 9 A. Absence of suicidality in 10 bulimia nervosa. 11 Q. Any others? 12 A. Not that I can recall. 13 Q. Was that paper on absence of 14 suicidality in bulimia published? 15 A. Yes, it was. 16 Q. Do you know where it was 17 published? 18 A. I believe it was the American 19 Journal of Psychiatry, I can't be sure on that. 20 Q. Okay. Was that paper a result 21 of a particular clinical trial or clinical 22 trials? 23 A. Yes, it was. 24 MR. MYERS: The bulimia paper? Page 51 1 THE WITNESS: Yes. 2 MS. ZETTLER: Correct. 3 Q. Were those clinical trials 4 performed to specifically study the incidence of 5 suicide and the use of Fluoxetine in treating 6 bulimia? 7 A. No, they were not. 8 Q. Was this a retrospective 9 analysis of other bulimia trials that had been 10 performed? 11 A. It was an analysis of the 12 suicide ideation and suicide acts in the bulimia 13 nervosa trials. 14 Q. What scale or scales were used 15 in the bulimia trials to measure suicidal 16 ideation? 17 MR. MYERS: Excuse me, in the trials 18 that form the basis of the manuscript? 19 MS. ZETTLER: Well, if there's a 20 difference, I would like to know that, but we can 21 start with that, yes. 22 A. The trials that form the basis 23 of the manuscript? 24 Q. Right. Page 52 1 A. What scales were used? 2 Q. Right. 3 MR. MYERS: To measure suicidality? 4 MS. ZETTLER: Right. 5 A. To measure suicidality, we used 6 the Hamilton depression scale. 7 Q. Okay. Any others? 8 A. Not that I can recall, no. 9 Q. Was that the twenty-one 10 question Ham-D, to your knowledge? 11 A. To my knowledge, it was the 12 twenty-one question, I can't be positive on that. 13 Q. And suicidality to my 14 understanding was measured by question three of 15 that scale? 16 A. I believe it was question three 17 of that scale. 18 Q. Any other suicide scales or 19 tests that were administered during those trials? 20 A. No. 21 Q. How about other trials done on 22 bulimia, were there any trials or other scales 23 other than the Hamilton depression rating scale 24 that were used? Page 53 1 A. We used other scales, yes. 2 Q. Okay. Any suicide specific 3 scales? 4 A. No, not that I'm aware of. 5 Q. Any scales that could also 6 measure suicidality such as the Ham-D? 7 A. I'm not aware of the scales in 8 the first two bulimia trials specifically. 9 Q. How many bulimia trials were 10 conducted prior to the publishing of the absence 11 of suicidality in bulimia paper? 12 A. Three. 13 Q. Were they all double blinded 14 controlled studies? 15 A. I believe they were all double 16 blind controlled studies. 17 Q. Were they single center or 18 multi-center studies? 19 A. They were multi-center studies. 20 Q. Do you remember how many 21 patients were enrolled in the studies in general, 22 together? 23 A. Both placebo and Fluoxetine? 24 Q. Right, total number. Page 54 1 MR. MYERS: Aggregates. 2 A. I believe it was over seven 3 hundred patients in total. 4 Q. That's all three studies? 5 A. That's correct. 6 Q. And when I say enrolled, I mean 7 entered the study, the studies, not completed. 8 A. There were over seven hundred 9 randomized patients. 10 Q. And how many out of those over 11 seven hundred randomized patients actually 12 completed the studies? 13 A. I can't recall. 14 Q. Can you give me an estimate, 15 was it more than fifty percent? 16 A. I can't recall. 17 Q. Do you remember how many 18 patients were analyzed in preparation of the 19 paper? 20 A. I don't remember the exact 21 number of patients that were analyzed in 22 preparation. 23 Q. Can you give me a general? 24 A. I know that we looked at all Page 55 1 randomized patients. 2 Q. Was it a matter of looking at 3 all the randomized patients and concentrating on 4 the ones who may or may not have exhibited 5 suicidal ideation, in other words did you break 6 it down at some point where you looked at people 7 who exhibited suicidal ideation or performed 8 suicidal acts? 9 A. Yes, we did. 10 Q. Have you heard the term hits, 11 have you ever heard that? 12 A. I've heard that term. 13 Q. Have you heard it used at 14 Lilly? 15 A. Yes, 16 Q. What's a hit? 17 A. A hit is when we find an 18 example of what we're looking for. 19 Q. Okay. Have you used that term 20 hits with regards to suicidal ideation or suicide 21 attempts? 22 A. I don't know that I myself 23 have, I don't know. 24 Q. Can you give me an idea of how Page 56 1 many people were looked at who were thought to 2 have been suicidal while on Fluoxetine in the 3 bulimia studies? 4 MR. MYERS: Are we talking about the 5 manuscript now? 6 MS. ZETTLER: Right. 7 A. I don't remember the number 8 from the manuscript. 9 Q. Can you give me a general idea, 10 was it more than fifty? 11 A. It was less than fifty. 12 Q. Was it less than ten? 13 A. I don't remember. 14 MR. SMITH: There was less than fifty 15 hits, is that what she said? 16 MR. MYERS: That wasn't the question, I 17 think -- 18 MS. ZETTLER: Less than fifty people 19 who were thought to have exhibited suicidal 20 ideation or suicidal attempts. 21 Q. Were there any other studies 22 that had been performed that were not taken into 23 consideration in preparation of this paper? And 24 I mean on bulimia studies. Page 57 1 A. Not to my knowledge. 2 Q. Was this purely United States 3 clinical trials or was this international trials 4 that had been performed? 5 A. I don't recall. 6 Q. To your knowledge, have any 7 obesity trials, clinical trials, been conducted 8 outside the United States? 9 MR. MYERS: Wait a minute, okay, the 10 question is obesity now? 11 MS. ZETTLER: I'm sorry, bulimia. 12 A. I don't know, I can't recall. 13 Q. Who else participated in the 14 preparation of the suicide bulimia manuscript? 15 A. Mike Wilson, Michael Wilson, 16 David Wheadon and Jan Potvin, Charles Beasley, I 17 believe, and I don't remember who else. 18 Q. Were you listed as an author on 19 that paper also? 20 A. Yes, I was. 21 Q. Did somebody go through the 22 data for the patients who were thought to have 23 exhibited suicidal ideation or committed suicide 24 attempts or suicide and make some sort of a Page 58 1 determination of causal relationship between 2 those attempts or ideations and the use of 3 Fluoxetine in preparation for the manuscript? 4 A. Yes. 5 Q. Who did that? 6 A. David Wheadon did. 7 Q. Anybody else? 8 A. Charles Beasley, if indeed he 9 was -- if I'm remembering correctly that Doctor 10 Beasley participated. 11 Q. Okay. Do you know if the 12 patients were blinded when -- or if the doctors 13 were blinded when they looked at the information 14 related to those patients? 15 A. I don't know, I don't remember. 16 Q. Were you involved in collecting 17 and providing the data related to the -- I'll 18 call them suicidal patients just so we don't have 19 to keep saying suicide and suicidal ideation; is 20 that okay? 21 A. That's okay. 22 Q. Were you involved in providing 23 the data for the suicidal patients to Doctor 24 Wheadon and possibly Doctor Beasley? Page 59 1 A. Yes, I was. 2 Q. What were your responsibilities 3 with regards to that? 4 A. My responsibilities were that I 5 provided the information that came from the site 6 on those patients, provided a copy of the form 7 1639 if there was one. 8 Q. Anything else? 9 A. Not that I am aware of. 10 Q. When you say the information 11 that came from the sites, would that be the 12 clinical report forms? 13 A. Yes. 14 Q. Any other information that came 15 from the sites? 16 A. Yes, lab report forms. 17 Q. Any other medical records? 18 A. No, not that I am aware of. 19 Q. How about clinician notes like 20 the investigators' notes? 21 A. They would have been 22 incorporated in the comment section of the 23 clinical report form. 24 MS. ZETTLER: Can we take a quick Page 60 1 break? 2 MR. MYERS: Sure. 3 (A SHORT RECESS WAS TAKEN.) 4 Q. Ms. Thompson, when you were 5 practicing in the private sector, prior to your 6 employment at Lilly, did you ever treat any 7 patients that were suicidal? 8 A. Yes. 9 Q. Did you treat patients who 10 presented not being suicidal, then became 11 suicidal? 12 A. Yes. 13 Q. How did you become aware that a 14 patient had become suicidal? 15 A. Through one-to-one conversation 16 with them, they -- I would ask them, are you 17 experiencing or are you thinking about harming 18 yourself in any way. 19 Q. What kinds of things would they 20 say that would indicate to you that they were 21 suicidal? 22 A. They would say yes, I am. 23 Q. Would there ever be an occasion 24 where they wouldn't be so direct but would Page 61 1 indicate to you indirectly that they were 2 suicidal? 3 A. Yes. 4 Q. What types of things, what 5 types of things would they say that would 6 indicate to you that they were suicidal other 7 than a direct yes answer? 8 A. They would express the fact 9 that they just didn't want to go on living, that 10 they saw no hope, that there was no out for them 11 but one. 12 Q. Okay. Did you ever administer 13 a Hamilton depression rating scale? 14 A. No. 15 Q. Did you ever administer any 16 other psychiatric tests? 17 A. Could you clarify that for me? 18 Q. Sure, there are a number of 19 different scales and tests that can be used to 20 diagnose various mental illnesses, correct? 21 A. Yes. 22 Q. Have you within your career as 23 a nurse or in your career at Eli Lilly ever 24 administered any psychiatric tests whatsoever? Page 62 1 A. Yes. 2 Q. What tests? 3 A. I administered tests in my -- 4 in the course of my thesis, my masters thesis. 5 Q. Can you give me an example of 6 what some of those tests were? 7 A. I can't tell you, I can't 8 remember the names of them. 9 Q. Okay. Can you tell me 10 generally what you were testing these people for? 11 A. Cognition, cognitive ability to 12 understand my questions. 13 Q. Have you ever administered any 14 psychiatric tests that were designed to measure 15 suicidality? 16 A. No. 17 Q. Are you familiar with a 18 M-S-S-I-R test? 19 A. Sounds familiar. 20 Q. Are you familiar with any 21 scales that are specifically designed to value 22 suicide or suicidal ideation? 23 A. I'm familiar with the Hamilton 24 depression scale. Page 63 1 Q. Okay. Is it your opinion that 2 that test is designed specifically to value 3 suicidal ideation? 4 MR. MYERS: Before she answers as to 5 any opinion questions, I assume you're asking her 6 as a nurse, right, not asking her as a medical 7 doctor opinion? 8 MS. ZETTLER: I'm asking her within her 9 experience and knowledge as a clinical 10 psychiatric nurse. 11 MR. MYERS: Okay. 12 A. Within my experience, no. 13 Q. What is that scale meant to 14 evaluate? 15 A. Depression. 16 MR. RUIZ: Which scale are you talking 17 about? 18 MS. ZETTLER: Hamilton depression 19 rating scale, the Ham-D. 20 Q. Are you familiar with how the 21 Hamilton depression scale is administered? 22 A. Yes. 23 Q. How's that done? 24 A. A person directs, reads the Page 64 1 question to the patient or the person taking the 2 test and then rates it. 3 Q. They read the exact question 4 that's listed on the scale? 5 MR. MYERS: Who's they? 6 MS. ZETTLER: The person administering 7 the test. 8 A. I don't know, I can't recall. 9 Q. Is it a subjective analysis at 10 all? In other words, is it something where a 11 person administering the test would in their own 12 judgment decide for themself which answer was 13 most appropriate to the patient's response? 14 A. I believe some questions are 15 subjective. 16 Q. Do you know which questions 17 were subjective? 18 A. No, I don't. 19 Q. Was question three subjective? 20 A. I don't know. 21 Q. Did you ever have occasion to 22 instruct site personnel on the administration of 23 the Hamilton depression rating scale? 24 A. No. Page 65 1 Q. In the bulimia trials that you 2 worked on, were people that were considered a 3 serious suicidal risk excluded from the study? 4 A. I don't remember. 5 Q. Did you work on the preparation 6 for any of the bulimia protocols? 7 A. No, I did not. 8 Q. Did you work on developing any 9 protocols for any clinical trials with 10 Fluoxetine? 11 A. No, not to my -- not that I can 12 remember. 13 Q. In your experience as a nurse, 14 clinical experience, have you treated anybody 15 suffering from movement disorders? 16 A. Yes. 17 Q. What movement disorders did you 18 treat? 19 A. Dystonias. 20 Q. Any others? 21 A. No, those were the typical 22 movement disorders that I assessed. 23 Q. How about akathisia? 24 A. Yes, akathisia. Page 66 1 Q. Can you tell me what the 2 symptoms of akathisia are? 3 A. Motor restlessness. 4 Q. Anything else? 5 A. Not that I know of. 6 Q. How about dystonia, what are 7 the systems of dystonia? 8 A. Dystonia is a muscle rigidity. 9 Q. Anything else? 10 A. Not that I can remember. 11 Q. How about tardive dyskinesia, 12 what are the symptoms of tardive dyskinesia? 13 A. Those symptoms are abnormal 14 facial movements, abnormal muscle movements, lip 15 smacking, tongue protrusion. 16 Q. How is akathisia diagnosed? 17 A. I don't diagnose akathisia. 18 Q. Are you familiar with how it 19 would be diagnosed if you were to? 20 A. I'm familiar with how it's 21 defined and how a physician would typically 22 diagnose it. 23 Q. What's your understanding of 24 how a physician would typically diagnose Page 67 1 akathisia? 2 A. My understanding is that the 3 patient is pacing, restless, without any 4 subjective anxiety symptoms, it's diagnosed as 5 akathisia. 6 Q. What do you mean by subjective 7 anxiety symptoms? 8 A. The person is restless, pacing, 9 and the psychiatrist will typically -- what I've 10 seen psychiatrists do is ask are you feeling 11 nervous, are you anxious about anything, if they 12 answer to the negative of that, that's typically 13 the way akathisia is looked at. 14 Q. Is akathisia a physiologically 15 based syndrome or psychologically based syndrome? 16 A. Akathisia is physiologically 17 based syndrome. 18 Q. How about dystonia, is that 19 physiologically based or psychologically based? 20 A. Physiologically based, that's a 21 hard word. 22 Q. How about tardive dyskinesia? 23 A. Physiologically. 24 Q. Do you have an understanding of Page 68 1 what the causes of dystonia and tardive 2 dyskinesia and akathisia are? 3 A. Yes. 4 Q. What are the causes? 5 A. It's typically related to 6 Dopamine, the blocking of Dopamine, blocking of 7 other chemicals. 8 Q. Are these syndromes or 9 illnesses typically related to the use of 10 neuroleptic medications? 11 A. Yes. 12 Q. Have they ever been associated 13 with anti-depressants? 14 A. I don't know, not that I'm 15 aware of. 16 Q. Is Prozac considered a 17 neuroleptic medication? 18 A. Would you define neuroleptic 19 medications for me, please? 20 Q. I can't. What is your 21 understanding of what a neuroleptic medication 22 is? 23 A. My understanding is neuroleptic 24 is often referred to as anti-psychotic drugs. Page 69 1 Prozac is not an anti-psychotic drug. 2 Q. Neuroleptic medications have 3 various modes of action, correct? 4 A. Yes. 5 Q. And to your knowledge are there 6 any neuroleptic medications that affect in 7 general neuro-transmissions, and 8 neuro-transmitters? 9 A. Yes. 10 Q. Are there any neuroleptic 11 medications to your knowledge that affect 12 serotonin? 13 A. Again, if neuroleptic 14 medications -- we're talking about 15 anti-psychotics, I believe. This is -- I believe 16 that some anti-psychotics do affect serotonin as 17 well as Dopamine. 18 Q. Is it your understanding that 19 anti-psychotics affect various 20 neuro-transmitters? 21 A. Yes. 22 Q. And Prozac or Fluoxetine 23 affects serotonin which is a neuro-transmitter, 24 correct? Page 70 1 A. Yes. 2 Q. In your experience as a 3 clinical nurse, how would you treat a person who 4 presented as suicidal? 5 A. Put them under very close 6 observation in a safe area. 7 Q. Would you hospitalize them? 8 A. Hospitalize them, yes. 9 Q. Did you ever have occasion to 10 recommend to a physician or a psychiatrist and a 11 physician that a patient be hospitalized because 12 they were suicidal? 13 A. No. 14 Q. Would that be a decision that 15 would be made by the physician? 16 A. Yes, it would be. 17 Q. Were you ever in a position to 18 make a recommendation that a patient be 19 hospitalized? 20 A. No. 21 Q. Other than hospitalizing the 22 patient, a patient who was presented as being 23 suicidal, what other treatment would be rendered? 24 MR. MYERS: That's in general? Page 71 1 MS. ZETTLER: I mean in her experience. 2 MR. RUIZ: And that's in her experience 3 as a nurse? 4 MS. ZETTLER: Sure. Let's put it this 5 way, if she's observed physicians rendering 6 treatment to suicidal patients, then I would like 7 to know about that also, but we can start with 8 your experience. 9 A. In my experience of a 10 psychiatric nurse, if a patient is a threat to 11 himself, they're hospitalized. 12 Q. But you don't simply 13 hospitalize a patient and wait for them to become 14 or to get over their suicidal ideation, there's 15 something else that's done for the patient while 16 hospitalized? 17 A. Yes. 18 Q. What other things are done for 19 that patient while hospitalized? 20 A. Psychotherapy and 21 anti-depressants, medication. 22 Q. Have you ever observed a 23 patient who has presented not being suicidal but 24 became suicidal? Page 72 1 A. Yes. 2 Q. How was the determination made 3 that they had become suicidal? 4 A. Typically by observation, most 5 typically by them telling you that they were 6 thinking of harming themselves in one-to-one 7 interaction or presenting with the symptoms that, 8 saying life isn't worth it. 9 Q. Same as somebody who presented 10 suicidal originally? 11 A. Yes. 12 Q. How's somebody who's suffering 13 from akathisia treated? 14 A. Typically with anticholinergic 15 medicine. 16 Q. If their akathisia is related 17 to the use of a neuroleptic, are they taken off 18 the neuroleptic? 19 A. It depends on the physician's 20 clinical opinion. 21 Q. Let's go back to the 22 preparation of the suicide bulimia paper. Did 23 you personally go through information from the 24 sites to determine which case report forms should Page 73 1 be reviewed by Doctor Wheadon and Doctor Beasley? 2 A. I didn't make that 3 determination. 4 Q. Who did? 5 A. All case report forms are 6 reviewed. 7 Q. Doctor Beasley and Doctor 8 Wheadon reviewed every single case report form? 9 A. No, they did not. 10 Q. What I am trying to get at is 11 were there some patient case files, okay, that 12 were separated for review by Doctor Beasley and 13 Doctor Wheadon? 14 A. Yes. 15 Q. Who did that separation? 16 A. I did sometimes. 17 Q. And what else -- who else would 18 have done that? 19 A. Other CRAs that were working on 20 the project, clinical research administrators. 21 Q. Can you give me some names? 22 A. I believe Pat Cowall, 23 C-O-W-A-L-L. 24 Q. Okay, anybody else? Page 74 1 A. I'm not sure. 2 Q. Catherine Mesner, did she work 3 on that project? 4 A. I don't think she worked on any 5 bulimia project -- I have to qualify that, I 6 don't think she did. 7 Q. How about Jeffrey Powell? 8 A. No, I don't think. 9 Q. Kevin Marks? 10 A. No. 11 Q. Was there a criteria that you 12 followed to make a determination as to which 13 patient files would be pulled for review by 14 Doctor Beasley and Doctor Wheadon? 15 A. Yes. 16 Q. What was the criteria? 17 A. We looked for any mention of 18 suicide, of hopelessness, of -- there was a 19 string of words, cutting, hanging, harming, and 20 if in doubt we gave it to Doctors Beasley or 21 Wheadon. 22 Q. Okay. When you say you 23 reviewed the patient files, is that an actual 24 physical review of each CRF or was that something Page 75 1 that was done to the computer data base? 2 A. That was -- the bulimia trial 3 was a computer CTM, computer trial management, so 4 it was reviewing, actual physically looking at 5 case report forms on the computer PC screen. 6 Q. Would you first do like a 7 computer search for these various terms that you 8 were talking about and then review those case 9 report forms or did you manually look at every 10 single case report form? 11 A. We did a computer search. 12 Q. So the group was first narrowed 13 down by whichever case files were pulled up, for 14 lack of a better word, by doing the searches? 15 A. Yes. 16 Q. Do you recall how many case 17 reports or case files were pulled up as a result 18 of the computer searches? 19 A. No, I don't recall at all. 20 Q. Do you recall how many case 21 files you have pulled or flagged for review by 22 Doctor Wheadon or Doctor Beasley as a result of 23 the criteria they set out, in other words the 24 ones that you felt were suicidal or committed a Page 76 1 suicide attempt? 2 A. I don't recall. 3 Q. Since this was all on computer, 4 I'm trying to get an idea of how it was 5 physically done. Were these case files separated 6 from the rest of the data base and then 7 transferred somehow to Doctor Beasley and Doctor 8 Wheadon on the computer to review? 9 A. I believe that we printed off 10 the screens for them to review. 11 Q. Okay. So you gave them hard 12 copies of the information that you thought that 13 they should take a look at? 14 A. Yes. 15 Q. Did you keep hard copies of 16 this information in your file? 17 A. I don't recall. 18 Q. Did you maintain files -- well, 19 do you maintain files at Lilly related to your 20 employment there? 21 A. Now? 22 Q. Yes. 23 A. Yes. 24 Q. How about back when you were Page 77 1 working on the bulimia suicide article? 2 A. Yes. 3 Q. What kinds of documents would 4 you have kept in your files? 5 A. Oh, I would have kept some of 6 the different correspondence back and forth to 7 the sites, I would have kept messages from 8 various Lilly employees, I would have kept 9 journal articles. 10 Q. Anything else? 11 A. Those were the major things I 12 would have kept. 13 Q. After -- have you ever heard of 14 a hit review sheet? 15 A. I don't remember hearing that 16 word. 17 Q. Okay. To your knowledge were 18 there forms filled out by Doctor Beasley or 19 Doctor Wheadon reflecting their review of the 20 individual patient files? 21 A. Yes, I believe there was. 22 Q. What were those forms called, 23 do you know? 24 A. I don't think we gave them a Page 78 1 word or a name, it was a form with a listing of 2 patients, we often called them our list. 3 Q. What did Doctor Wheadon and 4 Doctor Beasley do with the case files, patient 5 files that were pulled by you and other CRAs for 6 them to review? 7 A. I have no idea what they did 8 with them. 9 Q. I mean when I say what did they 10 do in their review, what was the purpose of their 11 review, first of all? 12 A. The purpose of their review? 13 Q. Right. 14 A. Was from a clinical medical 15 opinion to review the information that they were 16 looking at. 17 Q. To make what, to determine 18 what? 19 A. I don't know. 20 Q. Did they make a determination, 21 an initial determination as to whether or not 22 what was reported in the case file was actually a 23 suicidal ideation or suicide attempt? 24 A. I don't know what they did with Page 79 1 it after I gave it to them. 2 Q. Other than gathering the 3 information for the suicide bulimia paper, did 4 you have any other responsibilities with regards 5 to the preparation of that paper? 6 A. That was my primary 7 responsibility. 8 Q. Okay. What other 9 responsibilities did you have? 10 A. That was all that I can recall 11 specifically. 12 Q. Okay. Can you recall anything 13 generally? 14 A. No. 15 Q. How about did you have 16 responsibilities for writing any portion of the 17 paper? 18 A. No. 19 Q. Have you ever heard of a phrase 20 rechallenge study? 21 A. I have heard of that phrase, 22 yes. 23 Q. What is a rechallenge study to 24 your knowledge? Page 80 1 A. A rechallenge study to my 2 knowledge is if you've given a person a 3 medication for a specific indication and it 4 worked or it didn't work, after a period of being 5 off the medication, you would rechallenge them 6 with the medication again and again measure your 7 criteria. 8 Q. Could such a study be performed 9 on a person who was placed on a medication and 10 exhibited a particular adverse event? 11 A. Yes. 12 Q. In other words, could you use a 13 rechallenge study to test whether or not that 14 adverse event was related to the use of a 15 particular medication? 16 A. Yes. 17 Q. Are you aware of any 18 rechallenge studies that were performed or 19 proposed or considered by Lilly on Fluoxetine for 20 any reason whatsoever? 21 A. I don't remember any. 22 Q. Are you aware of what a 23 surveillance study is? 24 A. Yes, I am. Page 81 1 Q. What's a surveillance study? 2 A. Surveillance study is when you 3 look at a large population of people, you do a 4 survey, when you're looking for a specific 5 adverse event or a specific efficacy measure. 6 Q. Okay. Are you aware of any 7 surveillance studies that were performed on 8 Fluoxetine? When I say Fluoxetine, I mean for 9 any indicated use whatsoever, not just bulimia or 10 obesity, depression. 11 A. Not that I'm aware of. 12 Q. Do you know what a pilot study 13 is? 14 A. Yes. 15 Q. What is a pilot study? 16 A. It's a study when you're 17 initially piloting a drug for a specific 18 indication. 19 Q. When you say piloting, what do 20 you mean? 21 A. Trying it in a very small 22 population in people that exhibit that disorder. 23 Q. Okay. Are you aware of any 24 pilot studies that were performed on Fluoxetine Page 82 1 by Lilly or anybody on behalf of Lilly? 2 A. I don't remember any. 3 Q. Earlier when I asked you about 4 rechallenge and surveillance studies, are you 5 aware of any such studies that were performed on 6 Fluoxetine on behalf of Lilly, not just directly 7 by Lilly employees? 8 A. No, I'm not aware of anything 9 like that. 10 Q. Okay. Are you aware of any 11 rechallenge studies that were performed on 12 Fluoxetine related to the treatment of bulimia or 13 obesity and suicide or suicidal ideation? 14 A. No, I'm not. 15 Q. Other than bulimia, did you 16 work on any other indicated uses with Fluoxetine? 17 A. Yes. 18 Q. Which other indicated uses? 19 A. I worked on the final report 20 for obsessive-compulsive disorder and I worked on 21 the final report for obesity. 22 Q. What were your responsibilities 23 with regards to the final report for OCD? 24 A. I compiled the information for Page 83 1 the safety section. 2 Q. Anything else? 3 A. That was my only -- that's the 4 only thing I can recall doing. 5 Q. You didn't want to say primary 6 responsibility again and make me ask you a whole 7 bunch more questions. And when you say compiled 8 information for the safety section of the OCD 9 final report, what do you mean by compiled 10 information? 11 A. The report was -- the trials 12 were over and we were writing the report, so what 13 I would do is collect all of the reports that 14 went to the FDA, the 1639 report, and I would 15 list them, I would collect the listing of adverse 16 events during the trial, I would write tables 17 based on those listings, I wrote the table of 18 contents. 19 Q. Anything else? 20 A. Not that I'm aware of. 21 Q. Okay. When you say that you 22 listed the 1639s that were filed with the FDA, 23 you mean 1639s filed with the FDA as a result of 24 adverse events that occurred during the trials? Page 84 1 A. Yes, I did. 2 Q. Was that something that you did 3 manually or was that computerized? 4 A. It was computerized, the copy 5 came to me, hard copy. 6 Q. Are you aware of the DEN 7 network? 8 A. Yes, I am. 9 Q. Were all of these -- was all of 10 this information entered into the DEN? 11 A. Yes, it was. 12 Q. Did you ask somebody to pull 13 the 1639 information from the OCD trials and give 14 you a printout of that information? 15 A. Yes, I did. 16 Q. And then you compared that 17 against the hard copy forms of the 1639? 18 A. The printout that I received 19 from DEN was a copy of the 1639. 20 Q. Okay. To your knowledge, were 21 hard copy 1639s filled out with regards to these 22 adverse events prior to the events being entered 23 into the DEN? 24 A. Yes. Page 85 1 Q. Did you ever compare the 2 original hard copy 1639 with the DEN 1639? 3 A. I didn't, I did not compare 4 them. 5 Q. Other than listing the 1639s, 6 for the OCD trials, did you do anything else with 7 them as far as review them or anything of that 8 nature? 9 A. No. 10 Q. Did you list them by category? 11 A. Yes. 12 Q. I'm trying to get an idea of 13 physically how it worked, would you personally do 14 any computer queries or ask for any computer data 15 or would you have to go through somebody else to 16 get that data? 17 A. I would have to go through 18 someone else that knows the DEN. 19 Q. And you would ask them to, say, 20 give me all -- give me a listing of all adverse 21 events from the OCD trials broken down in a 22 particular way? 23 A. Yes. 24 Q. Would you do that by body Page 86 1 system? 2 A. Are you referring now to the 3 1639 reports? 4 Q. Right. 5 A. I believe that we did that by 6 body system. 7 Q. And under body system, a number 8 of event terms would be listed, correct? 9 A. Yes. 10 Q. So, for say nervous system, you 11 would have event terms such as tardive dyskinesia 12 or akathisia or things of that nature? 13 A. I don't remember if that falls 14 under the nervous system or not. 15 Q. But just as an example, you 16 would say body system or nervous system or CNS? 17 A. Yes. 18 Q. And under that would be listed 19 whatever was considered to fall under that 20 particular body system? 21 A. Yes. 22 Q. Would that be how you would ask 23 for the computer data related to the 1639 in that 24 instance where you listed it? Page 87 1 A. No, I would just ask for the 2 hard copy of the 1639. 3 Q. Okay. When you say you listed 4 the 1639s then, how would you list them? 5 A. I would list them according to 6 the ELECT dictionary as to where they went. 7 Q. I'm sorry, what dictionary? 8 A. The ELECT dictionary, I would 9 look at the ELECT dictionary and the defined term 10 would have been mapped to the ELECT dictionary 11 and I would put them under the body system that 12 they belonged to based on that dictionary. 13 Q. You would physically make a 14 decision on which body system the particular term 15 would fall under? 16 A. Yes. 17 Q. That wasn't something that had 18 already been done or could have been done through 19 the computer data base? 20 A. I'm not aware of what the data 21 base could do. 22 Q. Okay. How many 1639s did you 23 have to do this with? 24 A. I have no idea, I can't Page 88 1 remember. 2 Q. More than a hundred? 3 A. I can't remember, I have no 4 idea. 5 Q. Is it your understanding that 6 more than one adverse event could be listed on 7 any particular 1639? 8 A. Yes. 9 Q. Did you do that listing for 10 every single adverse event that was listed on 11 each 1639? 12 A. Yes. 13 Q. When -- how long did it take 14 you to complete that project? 15 A. I don't remember. 16 Q. Can you give me an idea, was it 17 more than a week? 18 A. I don't remember. 19 Q. When was this project done? 20 A. I believe it was early 1993. 21 Q. When you say the final report, 22 what's a final report? 23 A. When I say the final report for 24 OCD, I'm referring to the new drug indication, Page 89 1 the NDA for OCD. 2 Q. And that's the report on which 3 the FDA may or may not -- would base its approval 4 or disapproval of certain drugs? 5 A. Yes. 6 Q. You said you worked on the 7 final report for obesity also? 8 A. Yes. 9 Q. When was that one completed, if 10 it has been completed? 11 A. It's been completed. It was 12 following OCD so it would have been the first 13 again, right after the OCD, early 1993, I 14 believe, no, '92. 15 Q. So OCD was early 1992? 16 A. Yes, it was. 17 Q. To your knowledge, has that 18 final report for obesity been submitted to the 19 FDA? 20 A. I believe it has been. 21 Q. What else would you do with the 22 1639s besides list them in medical? 23 MR. MYERS: Which report are we talking 24 about now? Page 90 1 MS. ZETTLER: I'm sorry, we're talking 2 about the OCD report again. 3 A. Basically just compiling the 4 table, a list. 5 Q. Who asked you to do that? 6 A. Probably my department head at 7 the time. 8 Q. Who was that? 9 A. Carol Zapapas. 10 Q. You said another thing you did 11 with regards to the safety section on the OCD 12 final report was collect adverse event listings? 13 A. Yes. 14 Q. How is that different than what 15 you did with the 1639s? 16 A. The 1639s came from the DEN 17 system and they were events that were considered 18 serious events that warranted a 1639 report to 19 the FDA. The adverse event listing is any event 20 that was reported during the duration of that 21 trial that was within our large data base. 22 Q. Okay. Is it your understanding 23 that the information that's entered into the DEN 24 are serious events that occur during clinical Page 91 1 trials and all spontaneous adverse event reports 2 after a drug has been marketed? 3 A. Yes. 4 Q. And there was another separate 5 data base with regards to the non-serious adverse 6 events collected during the clinical trials, 7 right? 8 A. Yes. 9 Q. So this was a separate data 10 base that you were working with? 11 A. Yes. 12 Q. When you collected the adverse 13 event listings? 14 A. That's right. 15 MR. MYERS: Separate from what? 16 MS. ZETTLER: She just testified that 17 the serious clinical trial adverse events were 18 listed in the DEN, the non-serious were listed in 19 another data base, I just want to make sure we're 20 talking about two different data bases. 21 MR. MYERS: Okay. 22 Q. When you collected the adverse 23 event listings, how was that done, did you look 24 at computerized CRFs again or 1639 again or how Page 92 1 was that physically done? 2 A. Okay, how that was different is 3 there were no 1639s completed for drugs or for 4 events that didn't meet the criteria of serious 5 as defined by the FDA, this was a listing that is 6 a printout of the events by body systems. 7 Q. Okay. 8 A. As they occurred during the 9 course of the trial. 10 Q. Okay. And to your knowledge, 11 all of this information was information gathered 12 through the U.S. bulimia clinical trials, 13 correct? 14 MR. MYERS: Wait a minute. You're now 15 back on bulimia? 16 MS. ZETTLER: I'm sorry, OCD, it's been 17 a long week and a half, I'm sorry. 18 A. To my knowledge it would have 19 been the U.S., yes. 20 Q. So, am I correct in my 21 understanding that the non-serious clinical trial 22 adverse events were not reported to the FDA in 23 the form of a 1639? 24 A. That's correct. Page 93 1 Q. They were reported as part of 2 the final report? 3 A. Yes, they were. 4 Q. Were they reported in any other 5 way to the FDA? 6 A. They would have been reported 7 to the FDA during the course of the trial and the 8 annual report of the drug which is a report that 9 we do annually. 10 Q. Annually before the drug is 11 approved for use with, like in this case, OCD? 12 A. No. 13 Q. They'd be reported in the 14 annual reports post marketing? 15 A. Yes. 16 Q. Is there a name that, I'm just 17 trying to make it easier, is there a name that 18 you had for the non-serious clinical trial 19 adverse event data base? 20 A. No, there's no name for it. 21 Q. Can we agree to call it like 22 the non-serious event data base? 23 MR. MYERS: I'm going to object to 24 form, there are so many data bases, if you want Page 94 1 to call it the non-serious clinical trial adverse 2 events or something, but there are a lot of 3 different data bases that have been testified 4 about. 5 MS. ZETTLER: I'm just trying to make 6 it easier with regards to -- I'm going to ask her 7 some questions about the non-serious adverse 8 event data base. 9 MR. MYERS: If you call it the 10 non-serious clinical trial adverse events, that 11 is a separate population because she already said 12 the serious ones were in the DEN. 13 MS. ZETTLER: Right, I'm not asking her 14 about the serious ones right now. 15 MR. MYERS: Right, that's what I'm 16 saying. You can just call them the non-serious 17 clinical trial adverse events. 18 MS. ZETTLER: Let's shorten it so I 19 don't have to say it. 20 MR. MYERS: You wanted to add data base 21 and my only concern is that there are a lot of 22 data bases with respect to clinical trials. 23 MS. ZETTLER: Okay. 24 Q. Can we just call them Page 95 1 non-serious events at this point with the 2 understanding that when I say non-serious events 3 at this point I'm talking about the non-serious 4 adverse events that were collected during the 5 clinical trials for OCD, okay. 6 A. Yes. 7 Q. So you got a printout of the 8 non-serious events? 9 A. Yes. 10 Q. Were those non-serious events 11 categorized by body system on the printout? 12 A. Yes, they were. 13 Q. What was your responsibility 14 other than physically obtaining a copy of the 15 printout, would you have any other 16 responsibilities with regards to the non-serious 17 events listed? 18 A. We developed tables based on 19 the printouts. 20 Q. And what were you trying to 21 show in the tables? 22 A. Percentage of patients that 23 experienced the event during the course of the 24 trial. Page 96 1 Q. Anything else? 2 A. Not that I can recall. 3 Q. Who decided whether or not an 4 adverse event was serious in the OCD trials? 5 A. That depends on the definition 6 of serious. 7 Q. Okay. Is it your understanding 8 that there is a FDA definition or criteria under 9 which an adverse event would fall where it would 10 be serious, or considered serious or non-serious, 11 right? 12 A. Yes, there is. 13 Q. But within that criteria, there 14 is a certain amount of judgment that's involved 15 in deciding whether or not an event falls under 16 one of those criteria, isn't there? 17 A. Yes. 18 Q. Who would make that judgment as 19 to, number one, whether the event would fall 20 under the serious criteria and, number two, which 21 criteria it would fall under? 22 A. The research physician. 23 Q. Okay. And was this something 24 that was done before or after you asked for the Page 97 1 information from the non-serious event? 2 A. Before. 3 Q. That was done before it was 4 even entered into the data base, correct? 5 A. Correct. 6 Q. Were you ever involved in 7 making determinations as to whether or not a 8 particular event was considered serious according 9 to the FDA regulations? 10 MR. MYERS: In any setting now or -- 11 MS. ZETTLER: Yes, in any setting, 12 let's do it in any setting. 13 A. Yes. 14 Q. In what context, what 15 circumstance? 16 A. In the clear cut context. If 17 one of the definitions of serious is if the event 18 resulted in hospitalization, if the patient was 19 hospitalized, it was very clear that that was a 20 serious event and I would determine that a 1639 21 was needed. 22 Q. Okay. Then obviously if 23 somebody died, that would be considered a serious 24 event, correct? Page 98 1 A. Correct. 2 Q. What portion -- I guess I'm 3 trying to get an idea, you said that the 4 determination of whether or not an event was 5 considered serious was made before it was entered 6 into either the DEN or the other data base, 7 correct? 8 A. Yes. 9 Q. And what context within your 10 job did you have to make a determination -- in 11 other words, did you have to look at a particular 12 report on an adverse event and make a decision 13 whether or not it would be reported to the FDA 14 according to that serious criteria? 15 A. Yes, according to the FDA 16 serious criteria. 17 Q. Would that be something that 18 would arise in your responsibility of monitoring 19 or reviewing CRFs that came in from various 20 clinical trials? 21 A. Yes. 22 Q. Any other instances within your 23 employment at Lilly where that would happen 24 outside of your monitoring the clinical trial Page 99 1 CRFs? 2 A. No. 3 Q. As far as the adverse events 4 that were reported to the FDA, we can limit it to 5 the OCD trials at this point, were there any 6 other criteria besides serious that was taken 7 into consideration in deciding whether or not to 8 report an adverse event? 9 MR. MYERS: Let me object to the form 10 because she said that at some point or another 11 they were all reported and I think the only 12 distinction that you've drawn -- 13 MS. ZETTLER: On a 1639, let's do it on 14 a 1639. 15 A. So would you repeat the 16 question? 17 Q. Sure, let me see if I can 18 simplify it. My understanding is that an event -- 19 is that an adverse event is considered serious 20 under the FDA regulations if it falls under one 21 of those criteria and it's unexpected, or am I 22 getting that mixed up? 23 A. You're getting that mixed up. 24 Q. In what context does the Page 100 1 unexpected portion of the regulation come in? 2 A. If the event falls under one of 3 those criteria, a 1639 is completed. 4 Q. Regardless of whether or not 5 it's expected? 6 A. Regardless. 7 Q. Okay. And then where does the 8 expected or unexpected come in? 9 A. The research physician makes 10 that determination. 11 Q. Other than making the 12 determination as to whether or not a particular 13 event is expected or unexpected, what 14 significance, if any, does that determination 15 have? 16 MR. MYERS: On reporting? 17 MS. ZETTLER: I don't know, that's what 18 I'm trying to find out. 19 A. On reporting, the significance 20 is the days allowed to report it, the time frame 21 allowed to report it. 22 Q. Okay. Any other significance 23 other than on reporting? For instance, is it 24 related in any way to a determination of a causal Page 101 1 relationship between the adverse event and the 2 study drug? 3 MR. MYERS: When you say it, are you 4 now in the expectancy category? 5 MS. ZETTLER: Yes. 6 A. The physician also makes that 7 decision as to causality. 8 Q. I just want to know what your 9 understanding is of the impact of say you find -- 10 you have an event that is determined to be 11 serious and its determined to be unexpected -- 12 A. Uh-huh. 13 Q. Okay. Under that -- under 14 those two situations or that one combined 15 situation, serious and unexpected, would that 16 then require a determination of whether or not 17 the event was causally related to the use of the 18 drug? 19 A. Not to my knowledge. 20 Q. Okay. So to your knowledge, 21 the only significance or impact in the 22 determination of serious or unexpected would 23 have, under the regulations, would be as to 24 whether or not -- I forgot what you said earlier. Page 102 1 MR. MYERS: You said serious or 2 unexpected, you mean serious and unexpected? 3 MS. ZETTLER: And unexpected, I'm 4 sorry. 5 Q. Would be as to whether or not -- 6 I can't remember what you said. 7 A. I said the time frame. 8 Q. The time frame? 9 A. The time frame that you would 10 report it to the FDA. 11 Q. Is that your understanding 12 that's the only impact? 13 A. That's my understanding. 14 Q. Okay. And then did you create 15 any tables as a result of the listing of the 16 1639s? 17 MR. MYERS: OCD. 18 Q. The OCD 1639s? 19 A. I don't remember. 20 Q. Other than when you say that 21 you created the table of contents for the OCD 22 report, is that just a normal table of contents? 23 A. Based on FDA requirements. 24 Q. What are FDA requirements? Page 103 1 A. As to what needs to be 2 reported. 3 Q. Okay. You wouldn't make a 4 determination as to what was actually recorded in 5 the final report though, correct? 6 A. No, I would not make that 7 determination. 8 Q. You would go through and just 9 create the table of contents as it related to 10 what was actually reported in the report? 11 A. Yes. 12 Q. Anything else? 13 A. No. 14 Q. How about the obesity final 15 report, were your responsibilities the same as 16 they were with the OCD final report? 17 A. No, they were not. 18 Q. What responsibilities did you 19 have with regard to the obesity final report? 20 A. Taking the system output that 21 came from the system and compiling the 22 appendices. 23 Q. What do you mean when you say 24 the system output? Page 104 1 A. The system that has all the 2 information from the clinical report forms. 3 Q. Would all information contained 4 in the clinical report forms be placed somewhere 5 or another in an appendix? 6 A. Yes, typically. 7 Q. So you're talking about 8 demographic data, a patient's age, sex? 9 A. Yes. 10 Q. Was there a specific appendix 11 that was created just for safety data? 12 A. Yes. 13 Q. Was there a specific appendix 14 created just for data reflecting suicidal 15 ideation? 16 A. Not to my knowledge. 17 Q. Was there a computer program 18 that you could use or that someone at Lilly could 19 use to break down the data from the CRF into 20 various categories, such as demographics and 21 safety data, things of that nature? 22 A. Yes. 23 Q. When you -- so when you say the 24 system output, would the data come to you in that Page 105 1 sort of form, in other words was it demographic 2 data regarding all the patients that were 3 reviewed? 4 A. Yes. 5 Q. What kinds of things were 6 included in the safety appendix? 7 A. The percentage of the events by 8 body system was included. 9 Q. Okay. Similar to what we 10 talked about with regards to the non-serious 11 events? 12 A. Yes. 13 Q. For the bulimia trial? 14 A. Yes. 15 Q. The bulimia report, okay? 16 A. The treatment emergent signs 17 and symptoms were reported. 18 Q. How does that differ from the 19 adverse event? 20 A. An adverse event would be any 21 event that would occur at any time during the 22 trial. The treatment emergent is an event that 23 occurred, the person did not come into the 24 placebo lead in period if there was one with the Page 106 1 event. It was an event that emerged during the 2 course of treatment, double-blind treatment. 3 Q. So in other words, say the 4 patient comes in and during the placebo portion 5 of the study developed a rash? 6 A. Correct. 7 Q. That would be reported as an 8 adverse event but not as a treatment emergent 9 symptom? 10 A. That's correct. 11 Q. Was there a separate data base 12 to your knowledge in which the treatment emergent 13 symptoms were collected and stored? 14 A. No, not to my knowledge. 15 Q. Was there a similar situation 16 with the obesity studies in which the serious 17 adverse events would be collected in the DEN -- 18 I'm talking about clinical trials now and the 19 non-serious would be collected in another data 20 base? 21 MR. MYERS: Are you talking the 22 difference between what she described -- whether 23 what she described for the OCD, whether there was 24 a similar set or sets of data for the obesity? Page 107 1 MS. ZETTLER: Right. 2 A. Yes, there was a similar set of 3 data. 4 Q. So the serious events under the 5 FDA criteria under which a 1639 was filed would 6 be collected and stored in the DEN? 7 A. Yes, that's right. 8 Q. So did -- to your knowledge did 9 obesity have a separate non-serious event data 10 base, separate and apart from say OCD? 11 A. Yes, that event that was in DEN 12 though would also be in the other data base. 13 Q. Okay. Is that true also for 14 OCD? 15 A. Yes. 16 Q. So the other data base collects 17 all adverse events regardless of whether or not 18 they are serious? 19 A. That's correct. 20 Q. But the serious ones are also 21 contained within the DEN? 22 A. That's correct. 23 MR. MYERS: You're still talking about 24 clinical trials though, right? Page 108 1 MS. ZETTLER: Right. 2 A. Still clinical trials, right. 3 Q. Is there a separate data base 4 for treatment of emergent symptoms? 5 A. No. 6 Q. They were all collected again 7 according to whether or not they were serious? 8 A. That's correct, they were all 9 collected. 10 Q. So there would be treatment 11 emergent symptoms related to say OCD that were 12 contained in the DEN if they were considered 13 serious and there were treatment emergent 14 symptoms that would be contained in the other 15 data base? 16 A. Yes. 17 Q. How was the data on treatment 18 of emergent symptoms retrieved for purposes of 19 your tables in the bulimia studies? 20 MR. MYERS: Obesity. 21 A. In the obesity studies, the 22 analyst, the systems analyst, retrieved it. 23 Q. Okay. So you said to the 24 systems analyst basically, I want to know the Page 109 1 percentages of all treatment of emergent symptoms 2 that occurred throughout the obesity trials and 3 it was up to them to get that information for 4 you? 5 A. Yes. 6 Q. Anything else that was included 7 in the safety data? 8 A. Yes. 9 Q. What? 10 A. Vital signs. 11 Q. Okay. 12 A. And by that I mean heart rate, 13 blood pressure, temps, pulse, respirations, 14 laboratory results, any laboratory results that 15 were collected during the duration of the study, 16 those were the three main components of the 17 safety area. 18 Q. Okay. To your knowledge was 19 there ever a relationship that was either noticed 20 or determined between somebody who became 21 suicidal and a change in any particular vital 22 sign? 23 MR. MYERS: At what point? 24 Q. At any point in time throughout Page 110 1 the clinical trials on Fluoxetine that you're 2 aware of. 3 A. Not that I'm aware of. 4 Q. How about other laboratory data 5 like blood tests, things of that nature? 6 A. A relationship? 7 Q. Right. In other words, I mean 8 obviously just using it as an example, of people 9 who became suicidal while they were on 10 Fluoxetine, experienced a great increase in white 11 blood cell count, or something like that? 12 A. I know that that was looked at. 13 Q. Was that actually blood work 14 that was looked at or what was looked at in 15 comparison? 16 A. The clinical laboratory 17 results. 18 Q. Now clinical laboratory results 19 can include a lot of different things like blood 20 analysis and urine and things of that nature? 21 A. That's correct. 22 Q. Was there any specific labs 23 that were performed or looked at? 24 A. I don't think so, I don't know. Page 111 1 Q. How is it that if there was a 2 relationship between the laboratory's results and 3 suicidal ideation, it was performed or looked at? 4 MR. MYERS: How the relationship was 5 performed? 6 MS. ZETTLER: Or how was it 7 investigated? 8 A. To my knowledge, I can remember 9 collecting that information and delivering it to 10 a research physician on specific patients. 11 Q. In which trials? 12 A. On the bulimia nervosa trial. 13 Q. Was that again data on all 14 patients or was that on just suicidality specific 15 patients? 16 A. With the -- I'm confused, 17 because you said the relation on suicide 18 patients, was specific lab values looked at, and 19 then you're asking me on all patients. 20 Q. Okay, that's what I'm trying to 21 find out. Did they ask you to pull the lab data 22 on all the patients that were in the bulimia 23 trials or just on those patients who were in the 24 bulimia trials that were thought to have suffered Page 112 1 some sort of suicidality? 2 A. Any lab value that looked -- 3 that was outside of normal, the normal range, as 4 defined by the lab, was looked at by the 5 physician but when there was a specific person 6 who did have suicidal ideation, those specific -- 7 the lab values for that patient were pulled out 8 and given to the physician. 9 Q. Okay. Would that be all lab 10 values or just particularly like blood values or 11 urine values or any other testing that was done? 12 A. I don't remember. 13 Q. Who was the physician that you 14 gave that information to? 15 A. During the bulimia nervosa 16 trial, the physician was David Wheadon. 17 Q. Anybody else? 18 A. Then Charles Beasley. 19 Q. Were they looking at those 20 values in relationship to the preparation of the 21 suicidality and bulimia manuscript? 22 A. I don't know what they were 23 looking at them for. 24 Q. To your knowledge is it Page 113 1 possible to test for a level of Fluoxetine in the 2 blood system? 3 A. Yes. 4 Q. How is that done, do you know? 5 A. Fluoxetine blood levels are 6 drawn. 7 Q. I know that was an unfair 8 question. Is there such a thing as a therapeutic 9 level of Fluoxetine? 10 A. To my knowledge -- to my 11 knowledge there is no relationship between the 12 blood levels. 13 Q. So it's not like something -- 14 like looking in where you want to try to reach a 15 certain level -- blood level of the drug to 16 achieve a therapeutic effect? 17 A. That's correct. 18 Q. Is there any knowledge, and I'm 19 asking this particularly broad and I know it and 20 I admit it and you're probably going to object to 21 it, but to your knowledge, is there any knowledge 22 that can be gained from looking at a Fluoxetine 23 blood level? 24 MR. MYERS: I do object to the form Page 114 1 being overly broad, but if she knows subject to 2 that objection, she can certainly try to answer 3 it. 4 THE WITNESS: Would you repeat the 5 question? 6 Q. I don't know if I can make it 7 any clearer. I don't know much about this stuff 8 at all so I apologize. What I'm trying to -- I 9 mean why would somebody pull a Fluoxetine blood 10 level, why would you do that test, I guess? Can 11 you give me some reasons why? 12 A. You would do that test in the 13 course of a clinical trial to assess whether 14 there is any relationship between blood levels 15 and efficacy. 16 Q. To your knowledge, that was 17 done and there was no demonstrated relationship 18 between efficacy and blood levels, right? 19 A. That's what I believe to be 20 true. 21 Q. Are there any other reasons 22 that you would try to determine the blood level 23 of Fluoxetine? 24 A. Not to my knowledge. Page 115 1 Q. How about the safety context, 2 is there any knowledge that you can gain with 3 regards to safety by looking at Fluoxetine blood 4 levels? 5 A. Not to my knowledge. 6 Q. Do you know if the relationship 7 between the level of blood levels of Fluoxetine 8 and suicidality was ever looked at? 9 A. I don't know. 10 MS. ZETTLER: Can we take a quick 11 break. 12 MR. MYERS: Sure. 13 (A SHORT RECESS WAS TAKEN.) 14 Q. To your knowledge, is there a 15 way of determining a serotonin level? 16 A. Not to my knowledge. 17 Q. Do you know if that was a -- if 18 an attempt was ever made to see if you could 19 determine the serotonin level for instance by 20 taking blood samples? 21 MR. MYERS: By whom? 22 MS. ZETTLER: By Lilly. 23 A. To my knowledge there's no way 24 of measuring serotonin. Page 116 1 Q. Even in studying brain tissue 2 of somebody who's died? 3 A. To my knowledge, the person 4 would have to be alive or you wouldn't be able to 5 measure it. 6 MR. SMITH: Why do you have to be 7 alive? 8 Q. Why would you have to be alive 9 to measure the serotonin level in brain tissue? 10 A. This is my understanding of it, 11 and you're talking about a neuro-transmitter, a 12 substance that transmits from -- helps an impulse 13 go from one nerve cell to another nerve cell. If 14 the nerve cells are dead, nothing is going to go 15 between them. 16 Q. As far as determining the 17 amount of serotonin that may be in your brain at 18 any given time? 19 A. Well, you're way over my 20 specialty, I don't know. 21 Q. But it's your understanding 22 that there's at least a theory that depression is 23 caused by a chemical imbalance in the brain? 24 A. Yes, that's correct. Page 117 1 Q. And the chemicals that they're 2 referring to, at least in part when they say a 3 chemical imbalance, are chemicals that affect 4 neuro-transmission, correct? 5 A. Correct. 6 Q. And one of those chemicals is, 7 or substances is serotonin, correct? 8 A. Correct. 9 Q. So, to your knowledge, there's 10 no way of determining, through either an autopsy 11 or toxicology or any kind of levels that are 12 performed as a result of an autopsy, whether or 13 not -- well, first of all, what a normal 14 serotonin level would be? 15 A. That's correct. 16 Q. And then, of course, it follows 17 that if you can't determine what a normal 18 serotonin level would be, you wouldn't be able to 19 tell if say a person's system was producing too 20 much serotonin? 21 A. That's correct. 22 Q. Then how is it to your 23 knowledge that they couldn't make the 24 determination that depression is related to a Page 118 1 chemical imbalance in the brain? 2 MR. MYERS: They? 3 MS. ZETTLER: Anybody who has made that 4 determination or is positive of that theory. 5 A. To my knowledge, that's a 6 theory -- and excuse me. When you determine 7 levels, typically what we're talking about are 8 blood levels. If you're talking about serotonin 9 levels from a living person, you're going into 10 their brain while they're alive to take levels 11 and that's not typically done. A pharmacology 12 analyst or a developmental scientist would have 13 to tell you how serotonin levels are measured and 14 how that theory came to be. 15 Q. Okay, that's fair enough. I'm 16 sorry, could you tell me again what your position 17 is at Lilly now? 18 A. I'm a department head. 19 Q. And the department is the? 20 A. Medical neurosciences. 21 Q. You're in the medical division 22 but you're head of the neurosciences department? 23 A. That's correct. 24 Q. What does the neurosciences Page 119 1 department do? 2 A. We do clinical trials for the 3 safety and efficacy of drugs affecting the 4 nervous system. 5 Q. Does Fluoxetine fall in that 6 category? 7 A. Fluoxetine falls under that 8 category, yes. 9 Q. And specifically, what is your 10 responsibility as department head? 11 A. I supervise, I'm the direct 12 line management for CRAs, CIAs, which are people 13 who assist the CRAs in various functions, 14 secretaries, clerks. 15 Q. Do you have any responsibility 16 over medical personnel? 17 A. No, I do not -- or if you're 18 referring to physicians. 19 Q. Right. 20 A. No, I do not. 21 Q. How about nurses? 22 A. No. Well, let me -- we have no 23 nurses working in a nursing capacity as CRAs. 24 Q. Right. Page 120 1 A. A nurse who is a CRA currently, 2 I would supervise, and I don't know if any of my 3 current CRAs, I can't recall that any of them 4 have a nursing degree. 5 Q. But as far as you -- your 6 people work more in an administrative capacity? 7 A. Correct. 8 Q. When was the neurosciences 9 department established? 10 A. I don't know. 11 Q. Okay. Is there a 12 neuropsychopharmacology department either within 13 your department or in which your department 14 resides? 15 A. Yes. 16 Q. Is that different than a 17 psychopharmacology department? 18 A. Yes, they are two different 19 departments. 20 Q. So you're a department within 21 the neuropsychopharmacology department with a 22 medical division? 23 A. That's right. 24 Q. Is your department working on Page 121 1 Fluoxetine at this time? 2 A. No, it is not. 3 Q. What department within the 4 neuropsychopharmacology department works on 5 Fluoxetine at this time? 6 A. The psychopharmocology 7 department works on Fluoxetine. 8 Q. Okay, I'm getting confused. 9 When I asked you a couple of minutes ago about 10 whether or not Fluoxetine would fall under the 11 neurosciences department and you said yes, what 12 did you mean? 13 A. It's the global umbrella of 14 neurosciences. 15 Q. Not in your department? 16 A. Correct. There are three 17 departments under that global umbrella. 18 Q. What are the three departments? 19 A. I can't remember the specific 20 name of the third one. 21 Q. Okay. So when you say there 22 are three departments under that umbrella, are 23 you talking about the neurosciences umbrella in 24 the neuropsychopharmacology department or the Page 122 1 psychopharmacology department? 2 A. There are three departments 3 that fall under neurosciences. 4 Q. Okay. 5 A. That's the broad name of the 6 areas that work on medications that affect the 7 nervous system, the central nervous system. 8 Q. And you don't remember the 9 names of those departments? 10 A. No, I don't remember the 11 specific names. 12 Q. Do you remember the name of the 13 department that Fluoxetine would fall under? 14 A. Psychopharmacology. 15 Q. Okay. 16 A. I believe that Fluoxetine falls 17 under psychopharmacology. 18 Q. When did you become department 19 head of neurosciences? 20 A. July, 1993. 21 Q. So that was fairly recently? 22 A. Yes. 23 Q. And prior to becoming 24 department head of neurosciences, you had Page 123 1 responsibilities related to Fluoxetine? 2 A. No, I did not. 3 Q. Let me ask you this -- 4 A. Well, I talked about my 5 responsibilities related to Fluoxetine prior to 6 when I worked with Fluoxetine. 7 Q. Okay. When did you stop 8 working with Fluoxetine? 9 A. I stopped working with 10 Fluoxetine in October of 1992 -- well, excuse me, 11 June of 1992. 12 Q. So after June of 1992, you had 13 no responsibilities whatsoever with regards to 14 Fluoxetine? 15 A. Not that I can recall, no. 16 Q. Why is it that you stopped 17 working with Fluoxetine? 18 A. My study was finished, my final 19 report was submitted. 20 Q. Which study was that? 21 A. The bulimia nervosa, long-term 22 treatment trial. 23 Q. Bulimia trial and report were 24 completed in -- completed after the OCD final Page 124 1 report was finished? 2 A. No. 3 Q. Okay. So you worked on the OCD 4 report after the bulimia trial had finished? 5 A. Yes. 6 Q. So does that change the June, 7 '92 date? 8 A. No, it doesn't. That date was 9 when I stopped working on Fluoxetine. 10 Q. Have we pretty much covered 11 your responsibilities with regards to the obesity 12 final report? 13 A. Yes. 14 Q. And the OCD final report, 15 correct? 16 A. Yes. 17 Q. And so far with regards to the 18 bulimia study, we've talked about your review of 19 the CRF, correct? 20 A. Yes. 21 Q. And your administrative duties 22 over the sites? 23 A. Yes. 24 Q. Did you have -- and you just Page 125 1 testified that you had responsibilities with 2 regards to the final report on the bulimia study, 3 right? 4 A. Yes. 5 Q. Can you tell me what your 6 responsibilities with regards to that were? 7 A. Coordinating, collection of 8 data, coordinating writing efforts. 9 Q. Okay. Anything else? 10 A. Coordinating systems efforts. 11 Q. Anything else? 12 A. Making sure the data was 13 accurate and complete. 14 Q. Anything else? 15 A. Not that I'm aware of. 16 Q. Okay. Did you have any 17 specific responsibilities with writing any 18 portion of the bulimia report? 19 A. Yes. 20 Q. Which portions did you write or 21 help to write? 22 A. I helped write, I didn't write, 23 both efficacy and the safety sections of the 24 bulimia long-term report. Page 126 1 Q. Who else helped in writing 2 that? 3 A. Jan Potvin, David Wheadon. 4 Q. Anybody else? 5 A. Ben Ramsey and Michael Wilson. 6 Q. Who's Ben Ramsey? 7 A. Statistician. 8 Q. Who's Michael Wilson? 9 A. Statistician. 10 Q. Let me ask you this, these 11 reports that you worked on, would you have had -- 12 kept copies of the drafts of reports in your 13 files? 14 A. No, I probably would not have, 15 I don't recall whether I did or not. 16 Q. Okay. How about the final 17 draft, the final report, would you have had 18 copies of those in your files? 19 A. Not in my personal files, no, I 20 would not. 21 MR. MYERS: What point in time are we 22 now, I'm sort of in a void, what time plan are we 23 talking about? 24 THE WITNESS: We're talking about back Page 127 1 when I worked on bulimia nervosa which would have 2 been from 1989 until it was submitted, which was 3 I think around December of '91. 4 MR. MYERS: Okay. Sorry to interrupt. 5 Q. When you say you helped write 6 the safety and efficacy sections of the final 7 report on the bulimia long-term study, what do 8 you mean? 9 A. What I mean is I looked at 10 tables from systems output and put some words 11 around the tables based on working with the 12 statistician and the research physician. 13 Q. Okay. 14 A. I -- for the demographics, 15 there's a section in a final report that talks 16 about how the trial was run, methodology, the 17 entry criteria, reporting writing, all that, 18 pulling it together, seeing what was done. 19 Q. Okay. Would that be more 20 descriptive language as opposed to conclusive 21 language? 22 A. Yes. 23 Q. Did you set up tables or create 24 tables with regards to adverse events as you did Page 128 1 with the OCD and the obesity reports? 2 A. Yes, I did. 3 Q. Was your work with regards to 4 putting together that information similar to what 5 you did with the OCD and obesity reports? 6 A. Yes, it was. 7 Q. Did they have similar breakdown 8 of data bases with regards to bulimia study -- 9 what I mean is, the serious adverse events from 10 the clinical trials were collected in the DEN and 11 the non-serious as well as the serious serious 12 were collected in another data base? 13 A. Yes. 14 Q. And the same determination as 15 to what was serious as opposed to non-serious was 16 made by the clinical research physicians in the 17 case of the bulimia reports, or bulimia adverse 18 events? 19 A. By the clinical physician, yes. 20 Q. And the clinical physician in 21 this case was Doctor Wheadon? 22 A. Yes. 23 Q. Do you know if Doctor Beasley 24 worked on this final report? Page 129 1 A. I don't believe that he did. 2 Q. Did you ever work with John 3 Heiligenstein? 4 A. Not directly, no. 5 Q. Why are you laughing? 6 A. I'm laughing because I think I 7 know your next question. 8 Q. Indirectly? Have you worked 9 with him indirectly or have you worked with him 10 on a same project that he's worked on? 11 A. Not on a same project that 12 Doctor Heiligenstein worked on. 13 Q. How about working with him 14 indirectly? 15 A. That would be when Doctor 16 Heiligenstein would sometimes cover for Doctor 17 Wheadon when he was gone -- away from Lilly. 18 Q. Okay. Was Doctor Beasley sent 19 away? 20 A. We weren't talking Doctor 21 Beasley. 22 Q. No, I know, but he wants to 23 know if when Doctor Beasley was gone, was it 24 because he was sent away? Page 130 1 A. I don't know why Doctor Beasley 2 was gone. 3 Q. When you said you were 4 coordinating other efforts such as the systems 5 efforts and the writing efforts, explain what you 6 mean by coordinating? 7 A. Because there are so many 8 people, because there are different areas and 9 different people that are working all toward this 10 report, it takes someone to call meetings, 11 someone to make sure that everyone is there that 12 needs to be there, someone that writes minutes 13 during the meetings, and distributes 14 communications, that sort of coordination. 15 Q. Did you ever attend a meeting 16 where the subject was how to present the adverse 17 event reporting in the final report on the 18 bulimia studies? 19 A. Not that I'm aware of. 20 Q. Was there a procedure or, for 21 lack of a better word, protocol that Lilly 22 followed in how they would structure various 23 reports? 24 A. Yes. Page 131 1 Q. So the information that you 2 gathered was prepared by you according to 3 procedures that were set forth by Lilly? 4 A. The information that I gathered 5 was reported to the FDA. 6 Q. Right, but I mean as far as its 7 presentation in the report, was there a procedure 8 or some sort of system they wanted you to follow 9 with regards to how information would be reported 10 in the section regarding adverse events in the 11 final reports? 12 MR. MYERS: Are you asking if there is 13 like a format? 14 MS. ZETTLER: Yes, like a format. 15 A. There's a clear and concise way 16 of presenting information. There's no written 17 format. 18 Q. How did you know how to present 19 certain information within a table for instance? 20 A. I knew how to present it -- 21 could you clarify what kind of a table for me? 22 Q. Sure, say you're working on 23 your first final report, and they say we want you 24 to create a table that lists the percentages of Page 132 1 the various adverse events that were experienced 2 by people in the bulimia studies, okay. Did they 3 give you an example of how that had been done in 4 the past or was there a manual of some sort that 5 would direct you on how they wanted you to 6 present that? 7 A. The way that that was presented 8 is typically -- the way at that time, in my first 9 report, the way I was told to present it was to 10 present it in a forthright manner that would show 11 the percentage of patients that were experiencing 12 the event. 13 Q. And the percentages were not 14 percentages that you yourself came up with? 15 A. No, they were not. 16 Q. Who came up with the 17 percentages? 18 A. That was a mathematical 19 percentage that came from the system. 20 Q. To your knowledge, was that 21 done through a data base -- or I'm sorry, through 22 a computer program or was that something that 23 people in systems sat there and did by themselves 24 on a piece of paper with a calculator or Page 133 1 something? 2 A. To my knowledge, that was from 3 a data base. 4 Q. Were you involved in the 5 preparation for the FDA Advisory Committee 6 Meeting in September of 1991? 7 A. Yes, I was. 8 Q. What was your involvement in 9 that. 10 A. I was responsible for the 11 slides for that committee, slides that were 12 presented at the Advisory Committee Meeting. 13 Q. Anything else? 14 A. No. 15 Q. Were you involved in creating 16 the table of contents for the agenda for that 17 meeting? 18 A. No, not that I remember. 19 Q. Were you responsible for 20 creating the slides, and I don't mean making 21 actual slides but I mean creating the information 22 that would be presented on the slides? 23 A. The information was given to me 24 and then I put it in a form to take it to the Page 134 1 vendor to make a slide from it. 2 Q. So it was a matter of making it 3 look nice? 4 A. Yes. 5 Q. Was there anything else, did 6 you have any other responsibilities other than 7 making the information presentable by slides? 8 A. One of my responsibilities was 9 to read it and to make sure that I would be able 10 to know what it was about, that it was a clear 11 slide. 12 Q. Okay. Did you have any 13 responsibility in writing the report that was 14 submitted to the FDA prior to the meeting? 15 A. Yes, I did. 16 Q. What were your responsibilities 17 with regards to that? 18 A. A lot of the coordinating 19 again, calling meetings when people needed to be 20 together to make the information decisions, 21 distributing minutes, distributing draft copies. 22 Q. Did you have any writing 23 responsibilities? 24 A. I don't remember. Page 135 1 Q. Were you responsible for 2 accumulating data to be used and presented in 3 tables or presented within the text of the 4 report? 5 A. I don't remember on that 6 particular paper. 7 Q. Okay. To your knowledge, was 8 Doctor Beasley's British Medical Journal article 9 written as a result of that report? 10 A. Doctor Beasley's British 11 Medical Journal article was based on a 12 meta-analysis. 13 Q. Meta-analysis was different 14 than what was presented to the FDA at the 15 Advisory Committee Meeting? 16 A. Yes, there were differences. 17 Q. Okay. What were the 18 differences between what was presented at the 19 Advisory Committee and the -- what was presented 20 in Doctor Beasley's article? 21 A. One difference if I remember 22 correctly is Doctor Beasley's article discussed 23 depressed patients. At the Advisory Committee, 24 indications other than depression were presented. Page 136 1 Q. Was the data that was presented 2 to the Advisory Committee related to depression, 3 the same data that was discussed in Doctor 4 Beasley's British Medical Journal article, in 5 other words did he use the same patient 6 population, the same study criteria, things of 7 that nature for both? 8 A. I just don't remember. 9 Q. In the British Medical Journal 10 article, was information from the U.S. as well as 11 outside the U.S. analyzed? 12 A. I believe so. 13 Q. Was there a particular category 14 of information or clinical trials that were 15 reviewed such as double blind control studies as 16 opposed to other studies? 17 MR. MYERS: For what? 18 MS. ZETTLER: For the British Journal 19 or medical journal article. 20 A. I believe so. 21 Q. What category of trials were 22 used? 23 A. I believe it was double blind 24 controls. Page 137 1 Q. And strictly for the indication 2 of depression, correct? 3 A. I think so. 4 (PLAINTIFFS' EXHIBIT NO. 1 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 Q. Have you had a chance to review 8 Exhibit Number 1? 9 A. Yes, I have. 10 Q. Did you have any responsibility 11 in writing that letter? 12 A. I don't believe I had any 13 responsibility in writing this letter. 14 Q. Do you recognize the letter? 15 A. Yes, I do. 16 Q. Are you familiar with the 17 subject matter of the letter? 18 A. Yes, I am. 19 Q. Can you tell us what the letter 20 is? 21 A. I think the letter is the 22 letter that was sent to the FDA prior to the 23 September Advisory Committee Meeting. 24 Q. Can you tell me what Imipramine Page 138 1 is? It's on the second page of the exhibit under 2 bullet point two. 3 A. Imipramine is another 4 anti-depressant agent. 5 Q. To your knowledge, is it a 6 serotonin uptake inhibitor? 7 A. I believe it is. 8 Q. Is that a drug that's being 9 developed by Eli Lilly? 10 A. No. 11 Q. What's its brand name, if you 12 know? 13 A. Clozaril, I think. 14 Q. Is that a marketed drug to your 15 knowledge? 16 A. I think it is now, I don't 17 think it was at the time -- it was in Europe at 18 the time if I remember right. 19 Q. It was marketed in Europe? 20 A. I believe it was, I'm not sure. 21 Q. Are you aware of any 22 comparative studies done by Lilly with Imipramine 23 as a comparator drug? 24 MR. MYERS: What kind of trial. Page 139 1 MS. ZETTLER: Fluoxetine trial, 2 clinical trial. 3 MR. MYERS: Depression? 4 MS. ZETTLER: Any. 5 A. The only way I'm aware of it is 6 because I'm reading it. 7 Q. Okay. Were you involved in 8 collecting any of the data that's reported in 9 here in the first page on the fourth bullet point 10 down regarding -- actually any of the data that's 11 reported in any of this section, the first 12 section? 13 A. No, I did not collect 14 depressive disorder data. 15 Q. Did you collect depressive 16 disorder data from the international trials? 17 A. No, I did not. 18 Q. How about on the sections 19 toward the back on -- looks like page four -- I'm 20 sorry, it starts on page three of the letter 21 regarding obesity, did you collect any of that 22 information specifically? 23 MR. MYERS: What page are we looking 24 at? Page 140 1 MS. ZETTLER: Page three up at the top 2 of -- 3 A. No, I didn't collect any of 4 this data. 5 Q. How about the bulimia data on 6 the next page? 7 A. Yes. 8 Q. How about the 9 obsessive-compulsive disorder data? 10 A. No. 11 Q. Smoking cessation data? 12 A. No. 13 Q. Who asked you to collect the 14 data for the bulimia nervosa section of this 15 letter? 16 A. Could you clarify what you mean 17 by collecting the data? 18 Q. Sure. Earlier you testified as 19 part of your responsibilities with regards to 20 final reports, that at various final reports that 21 we've discussed, one of your responsibilities was 22 to -- I guess a better word would be retrieve 23 data from the data bases? 24 A. Correct, correct. Page 141 1 Q. Who asked you to retrieve the 2 data from the data bases for this portion of the 3 letter? 4 A. I don't remember who asked me 5 to do that. 6 Q. Do you know who Max Talbott is? 7 A. Yes, I do. 8 Q. Have you worked directly with 9 Mister Talbott -- Doctor Talbott? 10 A. Yes, I have. 11 Q. On what? 12 A. Not on a particular -- not on a 13 project, I have not worked with him on a project. 14 Q. In what way have you worked 15 with him directly? 16 A. I have worked with him because 17 he was the director of regulatory affairs at Eli 18 Lilly and Company. 19 Q. Okay. And in what context 20 would you have worked with Doctor Talbott? 21 A. He was my reporting line 22 director when I was department head of medical 23 writing services and medical regulatory services. 24 Q. Was that two separate positions Page 142 1 that you held? 2 A. No, that's one combined 3 position. 4 Q. Department head of medical 5 writing and medical regulatory? 6 A. Services. 7 Q. When were you department head 8 of medical writing and regulatory services? 9 A. From October of 1992 until July 10 of 1993. 11 Q. Okay. And October of 19 -- 12 A. '92. 13 Q. Did that department, department 14 of medical writing and regulatory services, work 15 with Fluoxetine in any way? 16 A. There was a medical writer 17 assigned to Fluoxetine, yes. 18 Q. Was she under your direction? 19 A. Yes, she was. 20 Q. Was that Janet Potvin? 21 A. Yes. 22 Q. Anybody else? 23 A. I think that Janet Potvin was 24 the only medical writer that was working with Page 143 1 Fluoxetine. 2 Q. Okay. 3 Q. Anybody else within your 4 department at that time that was working with 5 Fluoxetine? 6 MR. MYERS: Medical writing? 7 MS. ZETTLER: No, she said the 8 department of medical writing and regulatory 9 services. 10 MR. MYERS: Oh, okay. 11 A. Medical regulatory services 12 submits information to the FDA through the actual 13 mailing of information to the FDA under a 14 submission, so they would have for all of the 15 Lilly drugs and Fluoxetine is one of the Lilly 16 drugs. 17 Q. Was that just a matter of 18 filling out the submission form and mailing it 19 out or were there any other responsibilities that 20 those people had with regards to the regulatory 21 data? 22 A. It's basically a responsibility 23 of filling out the information and doing the 24 physical mailing of the data, they also -- Page 144 1 there's a secured area where the data is stored. 2 Q. The hard copy data? 3 A. Yes. All Lilly drug data is -- 4 MR. SMITH: Secured? 5 THE WITNESS: Yes. 6 Q. All the drug data or all the 7 adverse event data? 8 A. Both. 9 Q. Was it your experience that at 10 a certain point in time Lilly legal department 11 asked that you turn over all documents related to 12 Fluoxetine that you had in your files? 13 A. Yes. 14 Q. When did that start? 15 A. Well, I don't remember when it 16 started. 17 Q. Sometime in 1989? 18 A. I don't remember when it 19 started, the year. 20 Q. Okay. When the collection of 21 Fluoxetine data was started, how did that occur, 22 I mean how were you notified that they were going 23 to do that? 24 A. Through our legal department. Page 145 1 Q. And physically how were you 2 notified, was there a meeting that was held? 3 A. I don't remember if there was a 4 meeting that was held, I know that there was a 5 specific communication that was sent out telling 6 us exactly what we needed to do. 7 Q. And the communication, was that 8 in writing? 9 A. Yes, it was. 10 Q. Hard copy or on a computer? 11 A. Hard copy. There also was a 12 communication that went on the computer too. 13 Q. And that would be those 14 reminder communications? 15 A. Yes. 16 Q. How often did they ask you to 17 turn over Fluoxetine related documents? 18 A. I believe it was quarterly. 19 Q. Were you ever, in your 20 experience as an employee at Lilly, been asked to 21 turn over specific drug related documents on a 22 basis such as the Fluoxetine documents? 23 MR. MYERS: You mean for other drugs? 24 MS. ZETTLER: For other drugs. Page 146 1 MR. MYERS: To legal? 2 MS. ZETTLER: Yes, the same thing. 3 A. No. 4 Q. What did that original 5 communication say as far as the specifics of 6 turning over the documents? 7 A. It said that any document that 8 was in any way related to Fluoxetine should be 9 turned over. 10 Q. Okay. Was there a specific 11 procedure that they wanted you to follow in 12 turning over the documents? 13 A. Make a copy for your file if 14 you wanted to keep a copy and the original should 15 be turned over to legal in a box with a memo on 16 top of the box as to what you were turning over 17 so it could be located. 18 Q. Okay. The memo that you 19 attached to the top of the box, was that a memo 20 that specifically indicated what was contained in 21 the box? 22 A. Yes. 23 Q. So it would be, enclosed is my 24 letter to Joe Smith dated such and such regarding Page 147 1 for instance, bulimia? 2 A. No, it would not be that 3 specific. 4 Q. How specific would it be? 5 A. It would be, enclosed are -- 6 well, in fact it was a listing, it would be files 7 from bulimia nervosa, files from OCD, just giving 8 some examples, I don't remember any particular 9 box, investigator, messages, relating to trial, 10 long-term bulimia nervosa, or more general, not 11 specific. 12 Q. But you would break it down 13 somewhat into categories like correspondence with 14 investigators related to this study? 15 A. Yes. And I'm only addressing 16 what I was doing, too. 17 Q. I'm sorry? 18 A. I'm addressing what I did on 19 your quote just now. 20 Q. Were you asked to break your 21 document down, a list of documents in that manner 22 by the legal department? 23 A. We were asked to make sure that 24 what was in the box could be identified to be Page 148 1 retrieved, so you would know what it was. 2 Q. Okay. Did you separate your 3 documents by folder or anything of that nature? 4 MR. MYERS: When you say did she 5 separate them, when she kept them in files or 6 when she turned them over? 7 Q. When you turned them over, I'm 8 sorry. In other words, would you put all of that 9 correspondence with investigators for the bulimia 10 trial you were working on in one folder? 11 A. I don't know. 12 Q. Okay. Do you know if they were 13 organized chronologically? 14 A. I don't know how they were 15 organized. 16 Q. In Exhibit 1 on the fourth page 17 under section number four, regarding the bulimia 18 nervosa information, who is it that provided 19 these percentages and these statistics? 20 A. Statistician. 21 Q. Okay. Would you have then 22 retrieved the data from the various data bases 23 and presented that to the statistician for 24 analysis or is that something that you would have Page 149 1 retrieved per request of the systems analyst? 2 A. I would have retrieved it per 3 request of the systems analyst. 4 Q. So would you have specifically 5 made a request to them saying I want to know a 6 percentage of subjects who entered with a Ham-D 7 item prescore of less than -- or greater than 8 two, greater or -- what's that, I always screw up 9 those little symbols? 10 A. Greater than if it goes to the 11 right. I would have requested that Hamilton 12 depression rating scales be retrieved and then I 13 would have given the Hamilton depression rating 14 scale to the statistician. 15 Q. And then the statistician would 16 do the number punching and come up with the 17 percentages? 18 A. Yes. 19 Q. Who else was involved in 20 writing this letter, drafting the letter? 21 MR. MYERS: I'm going to object to the 22 format, she told you what she did. 23 Q. Do you know who else was 24 involved in creating this letter, putting Page 150 1 together the information that was contained in 2 this letter? 3 A. No, I don't. 4 Q. Okay. On page five, under 5 number seven, it says data from clinical trials 6 is selected, other anti-depressants? 7 A. Uh-huh. 8 Q. Are you familiar with what 9 anti-depressants are listed in that section? 10 A. No. 11 Q. Okay. Do you know what 12 information is blacked out generally, what type 13 of information is blacked out? 14 A. No, I don't know. 15 Q. To your knowledge, were any 16 consultants used in determining -- either in 17 determining what data would be presented in this 18 letter or determining how it would be phrased? 19 A. I don't know. 20 Q. Are you familiar with the name 21 Jan Fawcett, M.D.? 22 A. Yes, I am. 23 Q. How do you know Doctor Fawcett? 24 A. I met Doctor Fawcett at the Page 151 1 Advisory Committee -- prior to the Advisory 2 Committee, the day before in Washington. 3 Q. Did you create slides that 4 Doctor Fawcett used in his presentation to the 5 Advisory Committee? 6 A. Yes. 7 Q. Did you work with Doctor 8 Fawcett in presentation of his slides as far as 9 preparing him on which slides to use in which 10 portions of his presentation? 11 A. No, I did not. 12 Q. Did you work with him in any 13 way with regards to the slides? 14 A. Yes, I sent the slides to him 15 for his review. 16 Q. Okay. Did he make any changes 17 in the slides? 18 A. I don't remember. 19 Q. Besides his presentation at the 20 Advisory Committee meeting, to your knowledge has 21 Doctor Fawcett worked with Lilly in any other 22 capacity? 23 A. Not that I know of. 24 Q. Do you know how it was Doctor Page 152 1 Fawcett was chosen to speak on behalf of Lilly at 2 the Advisory Committee meeting? 3 A. No, I don't know. 4 (A SHORT RECESS WAS TAKEN.) 5 MS. ZETTLER: Larry, do you have a 6 major objection if Paul asks questions now? 7 MR. MYERS: I don't have a major 8 objection. 9 MS. ZETTLER: Do you have a minor 10 objection? 11 MR. MYERS: I don't know. 12 MS. ZETTLER: You don't know yet? 13 MR. MYERS: Why don't you ask some 14 questions and see where we get. 15 * * * * * * * * * * 16 CROSS EXAMINATION 17 BY MR. SMITH: 18 Q. Ms. Thompson, my name is Paul 19 Smith and I represent some individuals down in 20 Dallas. I have a few questions to ask you, I 21 will be brief as I can. If I ask you anything 22 that you don't understand, would you let me know? 23 A. Yes. 24 Q. Can you hear me all right? Page 153 1 A. Yes. 2 Q. I would like to talk with you, 3 if I can, about your experience as a psychiatric 4 nurse. 5 A. All right. 6 Q. And it's my understanding from 7 your earlier testimony that you had on occasion 8 treated individuals who were hospitalized as a 9 result of a depression illness? 10 A. That's correct. 11 Q. And were those individuals 12 admitted to the hospital with diagnosis of 13 clinical depression? 14 A. Yes. 15 Q. As opposed to some other type 16 of psychiatric condition, say bipolar, 17 schizophrenia and things of that nature? 18 A. Yes, but the term is major 19 depression, they would not say clinical 20 depression for a diagnosis. 21 Q. Those patients that you treated 22 had to be categorized as major depression 23 sufferers; is that correct? 24 A. I treated a variety of Page 154 1 patients, but what my point was that there is no 2 clinical diagnosis of clinical depression. You 3 asked me if I treated patients with clinical 4 depression. 5 Q. The diagnosis that was being 6 attributed to those individuals was major 7 depression illness? 8 A. Correct, yes. 9 Q. Were there certain criteria 10 that needed to be met for that criteria of major 11 depression illness or that diagnosis of major 12 depression illness? 13 A. Yes. 14 Q. What was that, please? 15 A. The Diagnostic Statistical 16 Manual Revised, Number 3. 17 Q. The DSMR 3? 18 A. Yes, DSMR 3, whatever, yes. 19 Q. In all of those individuals 20 that were hospitalized, would there be anything 21 done or did you observe anything done to test 22 those individuals concerning the extent of their 23 depression illness? 24 A. Yes, there were things done. Page 155 1 Q. What was done to make a 2 determination with respect to the extent of their 3 depression? 4 A. Typically an intake interview 5 by a psychiatrist. 6 Q. All right. Anything else? 7 A. That's the typical, based on 8 the psychiatrist's clinical opinion as to whether 9 they meet the criteria. 10 Q. Were there any formal tests 11 that were administered to the patients in 12 connection with this diagnosis? 13 A. Sometimes there were formal 14 tests done. 15 Q. What would those formal tests 16 have been? 17 A. Some of the types of formal 18 test is the MMPI, the Minnesota Multiphasic 19 Personality Inventory is sometimes done. 20 Q. I'm sorry, I don't mean to cut 21 you off. Can an individual or can a physician 22 make a diagnosis of major depressive illness 23 based on a MMPI? 24 MR. MYERS: Alone or in conjunction Page 156 1 with something else? 2 MR. SMITH: Alone. 3 A. No. 4 MR. CLEMENTI: This is her opinion as a 5 nurse? 6 MR. SMITH: Yes, not only as a nurse 7 but her opinion as an individual who's got a 8 masters in psychiatric nursing and has done 9 psychiatric counseling. Not just as a registered 10 nurse. 11 Q. Based on the full extent of 12 your education and work experience? 13 A. You asked me if any tests were 14 done in conjunction with the intake interview? 15 Q. Yes. 16 A. I gave you a name of a test 17 that was sometimes done in conjunction with an 18 intake interview that was a differential 19 diagnosistic procedure. 20 Q. That's the MMPI? 21 A. Yes. 22 Q. Any other tests administered? 23 A. Often psychiatrists order tests 24 to rule out an organic cause so they would order Page 157 1 an EEG, those type, a CAT scan of the brain is 2 frequently done. 3 Q. How about an MRI, magnetic 4 resonance imaging? 5 A. That's done if a differential 6 diagnosis is needed. 7 Q. Any other diagnostic studies or 8 testing tools done to determine the extent of 9 these individuals' depressive illnesses? 10 A. They used the Hamilton 11 depression scale. 12 Q. Of those psychiatric depressed 13 patients that you have been involved in the care 14 with, approximately what percentage of those 15 patients were administered the Ham-D? 16 MR. MYERS: Are we talking about 17 hospitalized patients? 18 MR. SMITH: Yes. 19 A. I can't answer that question. 20 Q. Would that be something that 21 would be done regularly or irregularly? 22 A. It would be contingent upon a 23 psychiatrist's decision to administer that and I 24 can't answer that. Page 158 1 Q. I understand that it would be 2 the psychiatrist's decision to do that, but in 3 what percentage were these psychiatrists making 4 that type of decision? 5 A. I can't answer that question, I 6 don't know. 7 Q. Approximately how many of these 8 inpatient individuals have you been involved in 9 caring for? And I mean those individuals who 10 have the major depressive illness. 11 A. It would be pure conjecture to 12 give you an answer for that because over that 13 many years, I can't tell you that. 14 Q. Can you give me a percentage of 15 those psychiatric patients that had the diagnosis 16 major depressive illness? 17 MR. MYERS: Percentage of what? 18 MR. SMITH: Of the patients that we're 19 talking about. 20 MR. MYERS: Of all psychiatric 21 patients? 22 MR. SMITH: Yes. 23 MR. MYERS: All right. Well, you were 24 talking about hospitalized patients. Page 159 1 A. Are you talking about the 2 percentage of hospitalized patients with major 3 depressive disorder? 4 Q. Yes. 5 A. It depends on a lot of 6 variables. Percentage rates went up and down in 7 inpatient hospitalization setting, I don't know 8 what the common percent over a year would be, I 9 wouldn't be able to tell you that. 10 Q. Well, would you consider that 11 based on your experience that you are familiar 12 with the care and treatment generally given to 13 individuals hospitalized for major depressive 14 illnesses? 15 A. Yes. 16 Q. Of those patients for whom you 17 cared, I believe you mentioned to me that there 18 were some who were suicidal? 19 A. Correct. 20 Q. Or became suicidal? 21 A. Correct. 22 Q. And can you give me a measurage 23 of those depressed patients that you treated that 24 were suicidal? Page 160 1 A. No, I can't. 2 Q. Or became suicidal? 3 A. No, I can't. 4 Q. Would you consider that as a 5 significant portion of that patient -- that 6 particular patient population? 7 MR. MYERS: Before she answers, I 8 object to the form and the use of the word 9 significant as being awfully vague and undefined. 10 What do you mean by significant? 11 MR. SMITH: Well, I asked her first if 12 she could give a percentage, she said she 13 couldn't. 14 Q. I am trying to get some concept 15 from you, Ms. Thompson, concerning the number of 16 majorly depressed patients you treated that 17 became suicidal or were suicidal. 18 A. I can't give you a number, I 19 wasn't taking demographic data. I wasn't 20 collecting that kind of data at the time, so I 21 can't give you a number. 22 Q. Was it more than one? 23 A. Yes. 24 Q. More than ten? Page 161 1 A. That became suicidal after they 2 were hospitalized? 3 Q. Or were suicidal at the time of 4 their admission? 5 A. Yes. 6 Q. More than ten? 7 A. Yes. 8 Q. More than twenty? 9 A. I don't know, I'm not going to -- 10 that would be pure conjecture. 11 Q. What type of treatment was 12 substituted for those individuals who were 13 suicidal? 14 A. They would be put in an area 15 where they could be observed closely, they were 16 given individual therapy. Sometimes through the 17 therapy, they were often given anti-depressant 18 drugs and some were given ECT treatment, electric 19 convulsive therapy treatment. 20 Q. Were you aware of any patients 21 who were under your care who were suicidal and 22 who were given Prozac, Fluoxetine? 23 A. I don't remember. 24 Q. Can you remember any of the Page 162 1 anti-depressant therapy that was given to those 2 suicidal individuals? 3 A. Yes. 4 Q. Tell me about that, please? 5 A. Amytryptiline, Nortriptyline, 6 Doxaphene, tricyclic anti-depressants. 7 Q. Did you observe in any of those 8 patients who were treated with tricyclic 9 antidepressants a worsening of the suicidality 10 factors in those patients? 11 A. It wouldn't be under my 12 judgment to decide if the suicidality was 13 worsening at the time. 14 Q. Well, as a psychiatric nurse, 15 were you not responsible for making observations 16 of those patients under your care? 17 A. Absolutely responsible. 18 Q. And recording observations? 19 A. Correct. 20 Q. Recording those observations in 21 the nurses notes? 22 A. Correct. 23 Q. I would assume based on your 24 extensive training and experience, that you Page 163 1 probably also participated in group health 2 project plans for particular patients? 3 A. That's right. 4 Q. Where you would interact with 5 psychiatrists, psychologists, nurses and other 6 health care personnel to work out patient 7 treatment goals for individual patients; is that 8 right? 9 A. That's true, yes. 10 Q. And my question to you is, did 11 you ever make an observation either in the nurses 12 note section of any patients you treated or the 13 meetings that we have been discussing or in any 14 way make an observation that the patient seems to 15 be more suicidal or less suicidal today? 16 A. That's a very difficult 17 question to answer. If a person is saying that 18 they're thinking of taking their own life, it's 19 very difficult to decide how that gets worse. 20 Q. Well, I am asking you if you 21 ever expressed that an individual seems to be 22 more suicidal or more bent on self destruction or 23 more obsessed with self harm than they were in 24 some previous period? Page 164 1 A. Probably, but I can't be sure 2 of that. 3 Q. That would have been part of 4 your job duties as a psychiatric nurse to make 5 observations of that? 6 A. That's right. 7 Q. You were probably in your 8 training given specific instructions concerning 9 the observation of these particular high risk 10 type patients, were you not? 11 A. That's right. 12 Q. And part of your training 13 required that you report your observations to the 14 psychiatrist in charge of that individual's care? 15 A. That's right. 16 Q. And my question is, did you 17 ever report a worsening of these suicidal type 18 symptoms? 19 A. And my answer was probably but 20 I can't remember specifically. 21 Q. Do you remember any instance 22 where you reported a worsening of these symptoms 23 regarding suicidality subsequent to the 24 administration of these tricyclic Page 165 1 antidepressants? 2 A. Typically if a person is ill 3 enough to be in inpatient hospital setting, they 4 are administered tricyclic anti-depressants when 5 they get there. 6 Q. So my question -- that's not 7 what I asked. My question is, do you recall 8 reporting a worsening of suicidal tendencies or 9 beliefs in a patient following the administration 10 of tricyclic antidepressants? 11 A. That's a different question 12 than you asked me before. 13 Q. That would be a yes or no 14 answer. 15 A. And I said that I don't recall 16 for sure. 17 Q. Well, have you read in the 18 literature in your studies or in your training or 19 have you observed in your experience any 20 worsening of suicidality following the 21 administration of tricyclic antidepressants? 22 A. I believe so. 23 Q. Were any of these patients who 24 were experiencing suicidal tendencies -- can I Page 166 1 call them suicidal tendencies? 2 A. Yes. 3 Q. Ever administered an MAO 4 antidepressant? 5 A. Yes. 6 Q. Do you recall making any 7 observations of worsening of suicidal tendencies 8 following the administration of an MAO 9 antidepressant? 10 A. I don't remember. 11 Q. Did you say that you had 12 rendered care and treatment for inpatients who 13 are suicidal and who had been administered 14 Fluoxetine? 15 A. I said I didn't remember. 16 Q. You don't remember any instance 17 of that? 18 A. I don't remember. 19 Q. Have you in your work history 20 treated or been involved in the care of patients 21 on an outpatient basis? 22 A. In my masters degree program, 23 yes. 24 Q. Would that involve -- or what Page 167 1 did that involve? 2 A. It involved working at the 3 community mental health center basically with 4 chronically mentally ill patients. 5 Q. Including individuals meeting 6 the DSM 3 R diagnosis of major depressive 7 illness? 8 A. Most of those patients were 9 schizophrenic patients. Some could have a 10 depressive illness in conjunction with 11 schizophrenia, but I don't remember. 12 Q. Do you know if any of those 13 individuals were treated with anti-depressants? 14 A. Yes. 15 Q. What type of anti-depressants? 16 A. Typically tricyclic 17 antidepressants. 18 Q. Do you recall any worsening of 19 suicidal tendencies in those patients? 20 A. I don't recall any suicidal 21 tendencies in those patients. 22 Q. Based on your experience and 23 your training, what is the concensus with respect 24 to when a depressed individual should be Page 168 1 hospitalized for treatment of that condition? 2 A. When? 3 MS. LAWS: I want to object to the 4 question to the extent that a concensus by whom 5 is not defined. 6 MR. RUIZ: Further, I'm going to object 7 based on the fact that she, I believe, is not 8 capable of making that determination as she is 9 not a psychiatrist or a medical doctor. 10 MR. CLEMENTI: I will join that 11 opinion. 12 MS. BRODSKY: So will I. 13 MR. MYERS: Answer it if you can. 14 MS. ZETTLER: So much for the 15 objections to form and responsiveness. 16 MR. MYERS: Do you remember the 17 question? 18 THE WITNESS: I believe the question 19 was when is a person typically hospitalized if 20 they're depressed. 21 Q. Yes. 22 A. And the answer is when they 23 become a threat to themself or others. 24 Q. Is that the only criteria for Page 169 1 inpatient treatment? 2 A. No. 3 Q. What other criterias are there 4 of which you're aware for inpatient treatment of 5 a major depressive illness? 6 A. Sometimes for brief group 7 therapy where they can be in one place for a 8 limited amount of time for group therapy or 9 individual therapy, sometimes if -- that's all I 10 can remember. 11 Q. Is there any relation to 12 bulimia and depression in your experience? 13 A. Would you define relation for 14 me? 15 Q. Is there any connection, does 16 depression cause bulimia, does bulimia result in 17 depression, or do you see those two conditions 18 existing concurrently in a significant number of 19 individuals? 20 A. They're two separate 21 conditions. 22 Q. Are they seen frequently 23 together? 24 A. I believe that there is a Page 170 1 co-morbidity of depressive illness with bulimia 2 nervosa. 3 Q. How about obsessive-compulsive 4 disorder, is there a co-morbidity between OCD and 5 depression? 6 A. I can't answer that. 7 Q. What about obesity? 8 A. I can't answer that. 9 Q. Smoking cessation? 10 A. I can't answer that. 11 Q. Alcoholism? 12 A. I believe there is a 13 co-morbidity with depression and alcoholism. 14 Q. Since you have been with Lilly, 15 have you talked with any patient who's 16 experienced suicidal ideation while on Prozac 17 therapy? 18 A. No. 19 Q. Have you been asked to by 20 anybody at Lilly? 21 A. No. 22 Q. Since you have been at Lilly, 23 have you talked with any clinical investigators 24 who have experienced -- had patients who have Page 171 1 experienced suicide, suicidal ideation or suicide 2 attempt? 3 A. Yes. 4 Q. While on Fluoxetine therapy? 5 A. Strike the yes, his question 6 wasn't over when I answered it. Repeat the 7 question for me again, please. 8 MR. SMITH: Read the question back. 9 (THE COURT REPORTER READ BACK THE 10 REQUESTED TESTIMONY.) 11 A. Yes. 12 Q. Which clinical investigators 13 have you talked with? 14 MR. MYERS: Don't identify them by 15 name. I am going to instruct her not to do that, 16 that's proprietary information, particularly 17 since the trials she's told you she worked on are 18 for unapproved. 19 Q. Did you talk with those 20 investigators in connection with the safety of 21 Fluoxetine and the suicide, suicide attempt or 22 suicidal ideation? 23 A. Yes. 24 Q. What were the names of those Page 172 1 investigators? 2 MR. MYERS: That also makes them the 3 reporter of an event. 4 MS. ZETTLER: And the order in the 5 Fentress case only covers independent third party 6 reporters and not the people specific to Lilly. 7 MR. MYERS: I understand your position. 8 MS. ZETTLER: Are you going to pay for 9 us to come back and take this woman's deposition 10 again when the Judge rules you have to answer 11 that question? 12 MR. MYERS: No. 13 MS. ZETTLER: I bet you are. 14 MR. MYERS: Ask another question. You 15 can ask her about the report, just not identify 16 the reporter. 17 MR. SMITH: I am talking clinical 18 investigators. 19 MR. MYERS: I understand that. 20 Q. I am talking clinical 21 investigators that you have had discussions with 22 that have had patients or participants in 23 clinical trials who have experienced suicidality 24 while on Fluoxetine. Have you talked with Page 173 1 clinical investigators who have had this 2 experience? 3 A. Yes, I have. 4 Q. And has it been in connection 5 with your work at Lilly? 6 A. Yes, it was. 7 Q. And has it been in connection 8 with your work at Lilly in determining the safety 9 of Fluoxetine for human consumption? 10 A. Yes. 11 Q. And has it had to do with any 12 of the work you were doing on any of these 13 studies that were later reported to the Food and 14 Drug Administration? 15 A. Yes. 16 Q. And has it had to do with the 17 Advisory Committee hearing? 18 A. No. 19 Q. What has it had to do with? 20 A. Follow-up on the safety of that 21 patient. 22 Q. And what are the names of those 23 investigators that you talked with? 24 MR. MYERS: I instruct you not to Page 174 1 disclose that. 2 Q. Tell me about how many 3 investigators you talked to about that subject? 4 A. I recall talking to one 5 investigator about that subject. 6 Q. One investigator? 7 A. Yes. 8 Q. Where was he located? 9 A. He was located in 10 Massachusetts, if I said that correctly, 11 Massachusetts. 12 Q. Where in Massachusetts? 13 A. Harvard. 14 Q. Harvard? 15 A. Yes. 16 Q. Was it Doctor Teicher, Martin 17 Teicher? 18 A. No, it was not. 19 Q. Was it anybody connected with 20 McClain Hospital? 21 A. Yes, it was. 22 Q. Was it Doctor Kohl? 23 A. No, it was not. 24 Q. Was it Doctor Rosenbaum? Page 175 1 A. No, it was not. 2 Q. What did that individual -- was 3 that a psychiatrist that you spoke with? 4 A. Yes, it was. 5 Q. And for what was he treating 6 that individual when you discussed the 7 suicidality aspects of that patient? 8 A. Bulimia nervosa. 9 Q. And did he report to you 10 factually the patient's history? 11 A. Well, I can't say whether he 12 factually did, I can't attest to the fact or 13 whatever. 14 Q. That's probably a bad question. 15 Did he report to you the history that he had 16 taken from the patient regardless of whether or 17 not the history was accurate? 18 A. Yes. 19 Q. What history did he report to 20 you concerning this patient? 21 A. If I remember right, that 22 particular patient had at least two previous 23 attempts. 24 Q. Of suicide? Page 176 1 A. Correct, if I remember right. 2 Q. All right. And had this 3 patient attempted suicide again while under 4 Fluoxetine therapy for bulimia nervosa? 5 A. The patient had attempted 6 suicide again while on the Fluoxetine trial. 7 Q. And did that psychiatrist tell 8 you how long it had been since the patient had 9 had the two previous attempts at suicide? 10 A. I would assume he did, I don't 11 remember specifically. 12 Q. Would that have been 13 significant to you in your inquiry, how long it 14 had been? 15 A. Yes. 16 Q. Since that patient had 17 attempted suicide in the past? 18 A. Yes. 19 Q. Why would that have been 20 significant to you? 21 A. Any safety information on that 22 patient would have been significant to me. 23 Q. But why would the time that had 24 elapsed since the previous suicide attempt and Page 177 1 the attempt during Fluoxetine therapy have been 2 of significance to you as a psychiatric nurse and 3 as an individual investigating this particular 4 adverse event? 5 A. I would have been interested in 6 how acute that patient was when she was admitted 7 to the trial. 8 Q. How acute? 9 A. Correct. 10 Q. Well, did the physician advise 11 you that she was suicidal upon entering the 12 trial? 13 A. I don't remember. 14 Q. What did -- well, did you ask 15 him? 16 A. I don't remember exactly what I 17 asked him. 18 Q. Would that have been 19 significant to you? 20 A. Yes. 21 Q. Did the bulimia nervosa trials 22 that he was running exclude individuals of 23 serious suicidal risk? 24 A. I don't remember the exclusion Page 178 1 criteria. 2 Q. What is your general 3 understanding concerning those individuals that 4 were serious suicidal risks or concerning whether 5 or not they were included or excluded from these 6 trials? 7 A. My general understanding is we 8 wouldn't include patients in trials that were a 9 serious risk at the time we were including them. 10 Q. So do I take it then from that 11 that probably this patient was not acutely 12 suicidal in that doctor's opinion when she 13 entered or he entered the clinical trial? 14 A. I can't remember what that 15 doctor's opinion was. 16 Q. Do you remember whether you 17 asked? 18 A. I don't remember. 19 Q. Was that patient on Fluoxetine 20 during the trial? 21 A. I don't remember. 22 Q. Would you have made some effort 23 to make that determination? 24 A. Yes. Page 179 1 Q. Was that a double blind trial? 2 A. Yes, it was. 3 Q. And you would have, in order to 4 get to the bottom of this, would have had to make 5 some ascertation concerning whether or not the 6 patient was on a placebo comparitor drug or 7 Fluoxetine? 8 A. That's correct. 9 Q. And this patient was on 10 Fluoxetine? 11 A. I don't remember. 12 Q. That's your best recollection 13 though? 14 A. That's my best recollection. 15 Q. And how long had that patient 16 been in the clinical trial when this other 17 suicide attempt occurred? 18 A. I don't remember. 19 Q. How long did that trial last? 20 A. Sixteen weeks on double blind 21 therapy. 22 Q. Followed by -- I mean preceded 23 by how much of a placebo wash out period? 24 A. Two weeks placebo lead in. Page 180 1 Q. So it could have been a total 2 of eighteen weeks from beginning to end? 3 A. That's right. 4 Q. Do you remember what portion of 5 that clinical trial that particular patient was 6 in? 7 A. No, I'm sorry, I do not. 8 Q. Did you fill out a 1639 on 9 this? 10 A. Yes, I would have. 11 Q. This third suicide attempt, was 12 that an attempt or was that a successful suicide, 13 was it a death? 14 A. There were no deaths in the 15 bulimia nervosa trial. 16 Q. Oh, that would not have been a 17 death? 18 A. That's correct. 19 Q. It would have been intent? 20 A. That's correct. 21 Q. Did you ask the doctor if he 22 had had any other patients that had expressed any 23 type of suicidal ideation? 24 MR. MYERS: In the trial? Page 181 1 MR. SMITH: Yes. 2 A. I don't remember. 3 Q. Would that have been something 4 that would have been of significance to you as 5 the clinical research administrator? 6 A. The safety of every patient 7 would have been significant to me. 8 Q. I understand. Would it be of 9 significance to you concerning patients' safety 10 if they expressed suicidal ideation during 11 clinical trials? 12 A. Yes. 13 Q. Did you ask the doctor whether 14 or not he had had any other patients who had 15 expressed suicidal ideations? 16 A. I don't remember. 17 Q. Do you think you would have? 18 A. I would have seen adverse 19 events reports that were coming in to me. 20 Q. No, I'm not asking you about 21 adverse event reports, I am asking you about your 22 conversation with this physician? 23 A. What I'm saying is if any other 24 patients had experienced suicidal ideation, there Page 182 1 would have been an adverse event report, I would 2 therefore have seen it when it came in to me. 3 Q. How are you sure that if any 4 other patient had experienced suicidal ideation 5 there would have been an adverse event report 6 filed? 7 A. I can't be sure. 8 Q. Well, was this particular 9 physician investigator instructed to report to 10 Lilly suicidal ideation as an adverse event 11 during the trial? 12 A. I wasn't an employee of Lilly 13 when that trial started, I don't know what that 14 physician was instructed to do. 15 Q. Did you instruct him to report 16 to you any suicidal ideation as an adverse event? 17 A. I don't remember whether I did 18 or not. 19 Q. Was this an in person 20 conversation or was this over the phone? 21 A. This was over the phone. 22 Q. How long did the conversation 23 last? 24 A. I don't know. Page 183 1 Q. Did you fill out any type of 2 working sheets or make any type of written 3 notifications during this interview? 4 A. I filled out a form 1639. 5 Q. But did you fill out any 6 working sheets for the form 1639? 7 A. I don't remember. My typical 8 is to put a 1639 in front of me and to write on 9 the 1639 as I'm talking. 10 Q. Was this an initial fifteen day 11 report? 12 A. I don't remember. 13 Q. Would this have been in your 14 file? 15 A. No, it would not have been. 16 Q. Why? 17 A. Because 1639s were submitted to 18 the drug epidemiology unit. 19 Q. Would there be any records of 20 your phone conversation with this physician in 21 your file? 22 A. If I wrote any records, yes, 23 they would have been in my file. 24 Q. And this would have been the Page 184 1 file that would have been turned over to Lilly 2 legal? 3 A. Yes. 4 Q. Would you have filed a 5 handwritten 1639 with the FDA? 6 A. What I would have done is I 7 would have handwritten on the form 1639, it would 8 have been sent to the drug epidemiology unit to 9 be data entered. 10 Q. Then what would have happened? 11 A. It would have been data entered 12 into the system. I would have gotten the draft 13 copy back to check to see if it matched what I 14 actually did say and then it would have been 15 permanent in the system. 16 Q. When you got the draft copy 17 back, would this have been something that you 18 would retain for your files? 19 A. I don't remember if I had a 20 draft, if I kept those draft copies or not. 21 Q. Do you think this would have 22 been something that would have been of 23 significance to you that you would have made 24 handwritten notes concerning this conversation Page 185 1 with this physician at Harvard, at McClain 2 Hospital? 3 MR. MYERS: Other than the note she 4 already described? 5 MR. SMITH: Right. 6 Q. I'm just trying to jog your 7 memory and help you with it because I understand 8 it's been sometime and you have done some other 9 things since then. 10 A. Uh-huh, if indeed I used the 11 form to write on as I was talking to the 12 physician, I don't know that I would have made 13 any other handwritten notes. 14 Q. Did you do any follow-up? 15 A. Yes. 16 Q. What did you do? 17 A. Followed up to see if the 18 patient, when the patient was released from the 19 hospital. 20 Q. Had the physician admitted the 21 patient to the hospital or had the patient been 22 admitted to the hospital? 23 A. I think so, I have to put a 24 qualifier on that. Page 186 1 Q. When the patient was discharged 2 from the hospital, did you check on the patient's 3 condition through the doctor? 4 A. I think so. 5 Q. What did he tell you concerning 6 the patient's suicidality, had it improved? 7 A. My assumption is that the 8 patient would still be in the hospital had it not 9 improved. 10 Q. But the patient was discharged? 11 A. Yes. 12 Q. So the physician felt that that 13 patient was no longer a risk of harm to his or 14 herself? 15 A. I don't know what the physician 16 thought. 17 Q. You don't know of any competent 18 physician, especially a competent physician 19 investigator, that you would request to do 20 clinical trials for your company that you would -- 21 that you would think would discharge a patient 22 who was suicidal, would you? 23 A. That's correct. 24 Q. And what else did the physician Page 187 1 tell you on your follow-up investigation other 2 than that the patient had been discharged from 3 the hospital? 4 A. I don't remember. 5 Q. Was that patient continued on 6 the bulimia trial? 7 A. No. 8 Q. Why? 9 A. Clinical judgment. 10 Q. Of who? 11 A. Our research physician. 12 Q. It was his clinical judgment 13 that the patient should no longer be given 14 Fluoxetine? 15 MR. MYERS: Let me object to the form, 16 she earlier testified she didn't know what drug 17 the patient was on. 18 MR. SMITH: She said she assumed it was 19 Fluoxetine. 20 MR. MYERS: No, sir, you must have 21 misunderstood. 22 THE WITNESS: Yes, I think so. 23 MR. SMITH: I doubt it. 24 MR. MYERS: I think so. Page 188 1 THE WITNESS: Would you read the 2 question for me, please? 3 MR. SMITH: Read the question back. 4 (THE COURT REPORTER READ BACK THE 5 REQUESTED TESTIMONY.) 6 A. Well, what you asked me was 7 whether the patient should remain in the trial 8 and I answered the patient did not remain in the 9 trial. 10 Q. Because it was a clinical 11 judgment of the investigator that the patient 12 should not continue to receive Fluoxetine? 13 MR. MYERS: No, I object to the form 14 because that's not what she said earlier, Paul. 15 You just misunderstood her, you mischaracterized 16 her testimony. 17 MR. MYERS: Go ahead and answer if you 18 can. 19 A. It was the clinical judgment of 20 the research physician that the patient should 21 not remain in the trial. 22 Q. Did he tell you why it was his 23 judgment that the patient should not remain in 24 the trial? Page 189 1 A. I don't remember. 2 Q. Did he feel that something in 3 the clinical trial experience caused or was any 4 way related to this lady's or this individual's 5 suicide attempt? 6 MR. MYERS: Let me object to the form 7 as to what the clinical research physician felt 8 is calling upon her to speculate as to what 9 somebody thought about something, unless she 10 knows independently. Can you answer that 11 question? 12 THE WITNESS: I cannot answer that 13 question. 14 Q. Was it the clinical 15 investigators that made the decision to terminate 16 the patient from the trial? 17 A. The patient was hospitalized 18 and terminated from the trial. 19 Q. Whose decision was made to 20 terminate the patient from the trial? 21 MR. MYERS: She's answered that. 22 MR. SMITH: I forgot, or I'm confused, 23 I'm not sure. 24 A. It's the research physician. Page 190 1 Q. The research physician at Lilly 2 or the investigator at Harvard? 3 A. They were both -- they both 4 agreed on that decision. 5 Q. All right. Who was the 6 clinical research physician? 7 A. David Wheadon. 8 Q. Did he talk with the 9 psychiatrist -- was it a psychiatrist? 10 A. Yes, it was. 11 Q. At Harvard? 12 A. I don't recall. 13 Q. Then why do you make the 14 statement that the clinical research physician 15 and the clinical investigator concurred in the 16 decision to terminate the patient from the trial? 17 A. Because of the separate times 18 when the patient was hospitalized violates the 19 protocol of the trial as a serious event and 20 there would be no doubt that the patient would 21 not remain on the trial. 22 Q. Is that an automatic 23 exclusionary or discontinuing criteria under the 24 protocol? Page 191 1 A. Yes. 2 Q. Is hospitalization? 3 A. Well, no, not hospitalization. 4 Q. From a serious adverse event? 5 A. Yes. 6 Q. Was this considered a serious 7 adverse event? 8 A. Yes, it was. 9 Q. Any other conversations that 10 you had with the clinical investigator concerning 11 this particular patient? 12 A. I don't recall any. 13 Q. Tell me about all the 14 conversations you had with Doctor Wheadon and the 15 clinical research physician on this particular 16 study. 17 MR. MYERS: About this patient or about 18 the study? 19 MR. SMITH: About this patient. 20 A. I don't remember the specifics 21 of the conversations that I had with Doctor 22 Wheadon. 23 Q. Can you tell me generally? 24 A. Generally, I would have given Page 192 1 him the 1639, I would have told him about my 2 conversation with the physician. 3 Q. As I understand it, it's your 4 recollection that the clinical research 5 physician, Doctor Wheadon and -- 6 A. Yes. 7 Q. And the Harvard psychiatrist 8 talked to each other concerning this patient; is 9 that right? 10 A. I said I didn't recall. 11 Q. Was that generally the practice -- 12 was it generally a practice for a clinical 13 research physician to talk with an investigator 14 directly when there's a serious adverse event 15 such as attempted suicide? 16 A. It was the general practice, 17 yes. 18 Q. Would the clinical research 19 physician generally make notes? 20 A. I don't know. 21 Q. Did you ever see any notes made 22 by a clinical research physician concerning 23 conversations with the particular investigator 24 concerning a particular adverse event that Page 193 1 occurred during a clinical trial? 2 A. No, I don't recall seeing any 3 notes like that. 4 Q. Was the clinical investigator 5 at Harvard keeping separate medical records on 6 this patient? 7 A. I don't know. 8 Q. Did you request medical records 9 concerning that patient? 10 A. I don't know. 11 Q. Do you know whether that 12 Harvard psychiatrist continued to treat that 13 patient? 14 A. No, I don't remember. 15 Q. Did you ever get the medical 16 records on that patient from the hospital to 17 which that patient was admitted following this 18 suicide attempt while on the bulimia clinical 19 trial? 20 A. I don't remember. 21 Q. Would this have been something 22 that would normally have been done? 23 A. No. 24 Q. Why? Page 194 1 A. Because hospitals normally do 2 not give records out to patients who are no 3 longer on clinical trials. 4 Q. Well, did you request of that 5 patient that they execute to you a medical 6 authorization granting that hospital authority to 7 allow you to look at the medical records? 8 A. I in no way had any direct 9 contact with that patient. 10 Q. Did anybody at Lilly make that 11 request? 12 A. I don't know. 13 Q. There is an authorization to 14 get medical records that is executed by patients 15 as they begin the clinical trials; is there not? 16 A. Medical records? 17 Q. In other words, doesn't a 18 patient when they begin the clinical trials, sign 19 some type of authorization to Lilly that allows 20 the clinical investigators to transmit their 21 patient medical records to Lilly for Lilly's 22 review? 23 A. Would you define what you're 24 talking by medical records? Page 195 1 Q. Any records concerning medical 2 treatment rendered by the clinical investigator 3 or at his direction. 4 MR. MYERS: Are you talking about the 5 CRF? 6 MR. SMITH: No, the clinical 7 investigator conducting the trial. 8 MR. MYERS: And I mean are you 9 including the CRF as a medical record is my 10 question? 11 MR. SMITH: A CRF or anything. Oh, you 12 mean clinical report forms, I thought when you 13 said CRF you meant clinical research physician 14 and I was spelling physician wrong. 15 MR. MYERS: Do you understand the 16 question? 17 A. Let me tell you what I 18 understand. And what I understand you saying is, 19 is there an authorization for a patient to give 20 to a research physician or an investigator to 21 give the records that are collected during the 22 course of a clinical trial while a patient is a 23 participant in that clinical trial; is that what 24 you're asking me? Page 196 1 Q. Yes. 2 A. Yes. 3 Q. If a patient is hospitalized 4 during the clinical trial, even though they might 5 be discontinued from the clinical trial, would 6 those hospital records be something that Lilly 7 would have authority to get from the clinical 8 investigator? 9 A. No, they would not. 10 Q. Is that something that has ever 11 been requested by Lilly? 12 A. I don't know. 13 Q. Do you know whether or not 14 Lilly paid for the hospitalization for that 15 particular patient? 16 A. I don't know. 17 Q. What was Lilly's practice 18 concerning payment for medical treatment that 19 would occur potentially as a result of an adverse 20 event occurring during the clinical trial? 21 A. The practice, as I recall it, 22 is that Lilly would pay the part of the medical 23 treatment that insurance did not cover. 24 Q. And in order to do that, Page 197 1 wouldn't you get permission from the patient to 2 get that patient's medical records? 3 A. No, you would not. 4 Q. You would not? 5 A. No, you would not. 6 Q. Anything else done concerning 7 that particular incident that occurred with 8 respect to follow-up on that patient? 9 A. I don't recall. 10 Q. Who would I need to talk to to 11 know what further follow-up was done concerning 12 that patient? 13 A. You're asking me for a person's 14 name? 15 Q. Yes. 16 A. David Wheadon. 17 Q. And he was the clinical 18 research physician? 19 A. Yes, he was. 20 Q. I guess the person that would 21 be most knowledgable concerning what follow-up 22 was done and what occurred with that patient 23 would be the clinical investigator, wouldn't it? 24 MR. MYERS: Well, let me object to the Page 198 1 form as to what the clinical investigator would 2 or would not know, that's highly speculative. 3 Answer it if you can. 4 A. The clinical investigator would 5 be the person that most typically follows up. 6 Q. In that instance, the clinical 7 investigator was the attending physician in the 8 hospitalization following the suicide attempt, 9 wasn't it? 10 MR. MYERS: I object to the form, I 11 don't know that that's been established who was 12 the attending or admitting or anything with this 13 patient. There's no testimony on that yet. 14 MR. SMITH: Well, I can't even get his 15 name, that's one reason I'm having difficulty 16 getting all the testimony. 17 MR. MYERS: Is the question was the 18 clinical investigator the attending physician in 19 the hospital? 20 MR. SMITH: Yes, or admitting 21 physician. 22 A. I don't know. 23 Q. Did you ask him if he had 24 followed this patient in the hospital? Page 199 1 MR. MYERS: Let me object to the form, 2 that's a different question than whether he was 3 the attending physician. 4 MR. SMITH: I know it, that's why -- if 5 you'll look when you get the deposition back, 6 Larry, you'll see a Q In front of it. 7 MR. MYERS: I'll do my best to do that, 8 to look at the following line. 9 A. I'm sorry what was your 10 question? 11 Q. Did you ask this physician, 12 this clinical investigator, if he followed the 13 patient in the hospital? 14 A. Probably, I don't remember. 15 Q. That would be something that 16 would be of interest to you as a clinical 17 research administrator, would it not be? 18 A. Yes, yes, it would be. 19 Q. And that would be something 20 that you would most certainly have asked, isn't 21 it? 22 A. I can't remember. 23 Q. Any other incidents that you 24 know of that you investigated where you talked to Page 200 1 physicians who had had the adverse event of 2 suicidality during any of the clinical trials 3 that you worked on while you were at Lilly? 4 A. I don't remember any. 5 Q. That's the only one as we sit 6 here? 7 A. That's the only one I remember 8 specifically. 9 Q. Do you remember any instances 10 where any individual died during the clinical 11 trial? 12 A. Would you specify what you mean 13 by clinical trials? 14 Q. Any clinical trials involving 15 Fluoxetine? 16 MR. MYERS: That she worked on? 17 A. That I worked on? 18 Q. Yes. 19 A. There were no deaths on any 20 trials that I worked on. 21 Q. And that's the only attempted 22 suicide? 23 MR. MYERS: I object to the form, 24 that's not her testimony, you mischaracterized Page 201 1 it. Your first question was did you talk to any 2 physicians about a suicide, suicidal act, that 3 was the premise of that whole line of question, 4 now you're asking were there any suicide 5 attempts. 6 Q. Were there any suicide attempts 7 during the clinical trial? 8 A. Yes. 9 Q. You told me about an individual 10 who attempted suicide during the bulimia clinical 11 trials in Harvard, right, with a psychiatrist at 12 Harvard? 13 A. Yes. 14 Q. Were there any others? 15 A. Yes, that attempted suicide, 16 yes. 17 Q. Did you make any investigations 18 or did you talk to the clinical investigators 19 concerning those other attempts? 20 A. I don't recall any 21 conversations as I sit here with other clinical 22 investigators. 23 Q. But you recall that there was 24 more than one attempted suicide? Page 202 1 A. That's correct. 2 Q. But you only talked with one 3 clinical investigator concerning one instance? 4 A. I only recall one conversation. 5 Q. Who -- would there be some 6 other CRAs that might have spoken with the other 7 clinical investigator involving another attempt? 8 A. Are you talking a specific 9 trial? 10 Q. Any trial or -- no, let's limit 11 it to bulimia nervosa. 12 A. Another CRA that was covering 13 for me while I was on vacation, et cetera. 14 Q. Who was that? 15 A. I don't know, I don't remember 16 who covered for me. 17 MR. SMITH: No further questions. 18 (A SHORT RECESS WAS TAKEN.) 19 * * * * * * * * * * 20 REDIRECT EXAMINATION 21 BY MS. ZETTLER: 22 Q. To your knowledge, did anybody 23 experience suicidal ideation while on a bulimia 24 trial? Page 203 1 MR. MYERS: Anybody? 2 MS. ZETTLER: Any of those volunteer 3 patients. 4 A. Yes. 5 Q. Do you remember on how many 6 occasions that occurred? 7 A. No, I don't remember how many 8 occasions. 9 Q. More than ten? 10 A. I don't remember. 11 Q. Do you remember a percentage 12 from the work you did in keying in the data in 13 the data bases? 14 A. I haven't reviewed that for a 15 couple of years, so I don't remember. 16 Q. How about somebody who became 17 depressed while on the bulimia trials? 18 MR. MYERS: Is the question, did any 19 patients become depressed? 20 MS. ZETTLER: Right. 21 A. I don't remember. 22 Q. How about a worsening of 23 depression, did any of the patients experience a 24 worsening of depression? Page 204 1 A. I don't remember. 2 Q. Would you look at Exhibit 1 3 again. You don't have to review the whole thing, 4 I'm just asking a general question. To your 5 knowledge, was that letter ever made public? 6 MR. MYERS: I object to the form, what 7 do you mean by made public, by who? 8 MS. ZETTLER: By either Lilly or the 9 FDA. 10 A. Not to my knowledge. 11 Q. Was this letter written and 12 sent to the FDA in response to a request by the 13 FDA for this information? 14 A. I don't know. 15 Q. Who would know that? 16 A. Bob Zerbe would know that. 17 Q. Anybody else? 18 A. I can only speculate as to who 19 else might know it. 20 Q. Would Max Talbott know? 21 A. I would assume that Max Talbott 22 would know. 23 Q. Are you familiar with a Charles 24 Nemerhof or Nemeroff? Page 205 1 A. Yes. 2 Q. Who's Charles Nemeroff? 3 A. He's a psychiatrist. 4 Q. Is he a Lilly employee? 5 A. Not to my knowledge. 6 Q. Okay. Do you know if he acted 7 as a consultant to Lilly at any time? 8 A. Yes, I think he did. 9 Q. When? 10 A. Well, I met Doctor Nemeroff at 11 the Advisory Committee. 12 Q. Okay. And he testified before 13 the committee on behalf of Lilly, correct? 14 A. Yes. 15 Q. Do you know, if other than that 16 capacity, he's ever acted as a consultant for 17 Lilly on any -- 18 A. I don't know other than in that 19 capacity. 20 Q. Are you familiar with Doctor 21 Gary Tollefson? 22 A. Yes, I am. 23 Q. Who's Doctor Tollefson? 24 A. Right now he's an Executive Page 206 1 Director at Eli Lilly and Company. 2 Q. Do you know when Doctor 3 Tollefson began working for Lilly? 4 A. I believe around 1989 or 1990. 5 Q. Are you familiar with a 6 gentleman named James Claghorn, C-L-A-G-H-O-R-N? 7 A. No, I'm not. 8 Q. How about David Dunner? 9 A. No, I'm not. 10 Q. Xavier Escabar? 11 A. No. 12 Q. Jeffrey Lieberman? 13 A. No. 14 Q. Michael Bernstein? 15 Q. 16 A. No. 17 Q. Linda Hazel? 18 A. No. 19 Q. Regina Casper? 20 A. No. 21 Q. Nina Schooler? 22 A. Yes. 23 Q. Who was Nina Schooler? 24 A. I believe she was on the FDA Page 207 1 Advisory Committee. 2 Q. To your knowledge, has Doctor 3 Schooler ever been affiliated in any way with Eli 4 Lilly? 5 A. Not to my knowledge. 6 Q. To your knowledge, has Doctor 7 Schooler ever conducted a clinical trial on 8 behalf of Lilly on any medication? 9 A. I don't know. 10 Q. Has Doctor Schooler ever 11 consulted with Eli Lilly? 12 A. I don't know. 13 Q. What are time to slides, 14 T-I-M-E T-O slides? 15 A. I don't know. 16 Q. You put together the slides for 17 the Advisory Committee meeting, correct? 18 A. Correct, that's right. 19 (PLAINTIFFS' EXHIBIT NO. 2 WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 MR. MYERS: Have you a specific 23 question about this lengthy document? 24 MS. ZETTLER: Yes, turn to Pz 1889 191. Page 208 1 Q. If you look under Roman numeral 2 4, capital B? 3 A. Oh, uh-huh. 4 Q. Does that refresh your 5 recollection as to what the time to slides are? 6 A. I believe the time to slides 7 were the time to until the patient exhibited 8 suicidal ideation or an act, I believe. 9 Q. Time to, so instead it should 10 have been time until? 11 A. Correct, yes. 12 Q. What are two and three arm 13 trials that are listed under Roman numeral three, 14 letter E? 15 MR. MYERS: What are the trials listed 16 there or what are -- what is it you want? 17 MS. ZETTLER: What generally. 18 A. Generally a two arm trial is a 19 trial that has two treatment groups and a three 20 arm trial is a trial that has three treatment 21 groups. 22 Q. What do you mean by treatment 23 groups? 24 A. An example would be on a three Page 209 1 arm trial, one would be Fluoxetine, one would be 2 a placebo, one would be a tricyclic group. 3 Q. Were you ever asked to collect 4 data in preparation for the Advisory Committee 5 meeting related to hostility or aggression as it 6 related to the use of Fluoxetine? 7 A. I don't remember my part in 8 collecting that data. 9 Q. Okay. But you did play a part 10 in collecting it? 11 A. I believe that that data was 12 part of the data when we reviewed data that we 13 collected and so my part in my recollection would 14 be obtaining the data from where it was located. 15 Q. Okay. I believe earlier you 16 testified that in pulling the information on 17 suicidality, you ran a number of terms? 18 A. Yes. 19 Q. Was that also done in pulling 20 the data for the hostility aggression 21 information? 22 A. I believe it was. 23 Q. Do you remember any of the 24 terms that were used to try to pull up hostility Page 210 1 aggressive behavior information? 2 A. No, I don't remember those 3 terms. 4 Q. The slides that you prepared 5 for the Advisory Committee meeting, were those 6 slides that were shown at the open meeting? 7 A. Yes. 8 Q. Was there another portion of 9 the meeting that was closed to the public to your 10 knowledge? 11 A. Not to my knowledge. 12 Q. Do you recall whether or not 13 Lilly provided any written information to the 14 public during the open portion of the meeting? 15 A. I don't recall. 16 Q. Would you look at page 175 of 17 that Pz 1889 175, it's just four or five pages in 18 the back. Is that your handwriting at the top? 19 A. No, I don't think it is. 20 Q. Did you prepare this outline of 21 the slides? 22 A. I prepared outlines, I don't 23 remember if I prepared this specific outline. 24 Q. At the bottom, I believe it's Page 211 1 15 and 16, it says prophylactic trial? 2 A. Uh-huh. 3 Q. What's a prophylactic trial? 4 A. Typically -- I don't know what 5 this particular prophylactic trial means, 6 typically what a prophylactic trial is is a trial 7 where you're giving a compound to prevent a 8 person from developing a disorder of some sort. 9 Q. Are you aware of any 10 prophylactic trials that were performed with 11 regards to Fluoxetine? 12 A. No, I'm not. 13 Q. Okay. 14 Q. Would you perform a 15 prophylactic trial with regards to a disease like 16 depression? 17 A. That's a medical doctor's 18 decision. 19 Q. Would you look at the second 20 page of the exhibit, at the top it says 21 manuscripts submitted for publication, papers 22 published. Do you know what the purpose of this 23 section of the table of contents is? 24 A. No. Page 212 1 Q. Who is the J. K. Bannon name on 2 it? 3 A. That's Julie Bannon who was a 4 CRA. 5 Q. Is she still with Lilly? 6 A. Yes, she is. 7 Q. Do you know what her role was 8 in the preparation of this for the Advisory 9 Committee meeting? 10 A. Yes, she assisted me in the 11 preparation of slides. 12 Q. Okay. The suicidality, U.S. 13 depressions, slash or dash British Medical 14 Journal article, is that the Beasley article? 15 A. I would assume it is, I can't 16 be sure it is. 17 Q. Do you know when the Beasley 18 article was first published? 19 A. I believe it was after this 20 time, I believe it was -- well, I don't remember 21 the date on it. 22 Q. Do you know who the first two 23 pages of this document were prepared for? 24 A. No, I don't. Page 213 1 Q. How soon after the Advisory 2 Committee meeting was the Beasley article in the 3 British Medical Journal published? 4 A. I don't remember, I'm having a 5 hard time recalling when that article was 6 published. 7 Q. Do you know if it was a long 8 period of time after the meeting? 9 A. I don't believe it was a long 10 period of time. 11 Q. Under it it says papers 12 accepted, OCD suicidalities, are you familiar 13 with that paper? 14 A. I remember -- I remember that 15 paper, I'm not familiar with the contents of that 16 paper. 17 Q. Was that paper ever published? 18 A. I don't know. 19 Q. Was it a paper related to 20 suicidality and the use of Fluoxetine to treat 21 OCD? 22 A. It would have been a paper in 23 relation to suicidality and OCD clinical trials. 24 Q. Okay. Another retrospective Page 214 1 sort of review of the information that had been 2 obtained through the clinical trials? 3 A. From what I remember about it, 4 yes. 5 Q. How about the hostility paper 6 that was submitted to JAMA? 7 A. I don't remember much about 8 that. 9 Q. Okay. 10 (PLAINTIFFS' EXHIBIT NO. 3 WAS 11 MARKED FOR IDENTIFICATION AND 12 RECEIVED IN EVIDENCE.) 13 Q. Have you had a chance to look 14 at Exhibit 3. 15 A. Yes, I have. 16 Q. Can you tell me what that is? 17 A. This is a periodic report 18 notice that goes out for every Lilly compound and 19 it's a reminder that the data cut off date for 20 the compound, the data cut off date, and reminder 21 that the annual report is due to the FDA. 22 Q. Annual reports are again 23 reports done each year after a drug is marketed? 24 A. There are types of annual Page 215 1 reports, one to an NDA, a new drug application, 2 and one to an IND report, so, yes. 3 Q. NDA reports would be annual 4 reports filed with regards to a drug that has 5 been approved for an indication, correct? 6 A. Yes. 7 Q. And in the second -- at the top 8 of that it says IND 12274 Prozac Fluoxetine 9 Hydrochloride compound and then it says Lovan 10 antiobesity, that's an IND? 11 A. Yes. 12 Q. That indicates that at this 13 time at least it was still pending approval, 14 correct? 15 A. That's correct, yes, that's 16 correct. 17 Q. Under that it says NDA 18 dash 18 936? 19 A. Uh-huh. 20 Q. Prozac Fluoxetine Hydrochloride 21 bulimia depression? 22 A. Uh-huh. 23 Q. That indicates that there was -- 24 that both bulimia and depression were at the NDA Page 216 1 stage? 2 A. No, the bulimia submission was 3 filed as a supplement to the depression NDA data. 4 Q. Why was it filed as a 5 supplement as opposed to a separate IND? 6 A. It met the criteria of being a 7 supplement to the information that we knew on 8 depression. 9 Q. Okay. What do you mean by a 10 supplement to the information you knew on 11 depression? 12 A. The depression NDA was filed 13 and the bulimia nervosa -- the FDA had specific 14 regulations for what constitutes a new drug 15 application and what can be a supplement to the 16 new drug application and in a safety report, et 17 cetera, and this was a supplement to the new drug 18 application of depression and that's why it was 19 put together like that. 20 Q. So in effect you're not waiting 21 for technical approval for use of Fluoxetine 22 Hydrochloride in the treatment of bulimia? 23 A. Yes, we are waiting for 24 approval. Page 217 1 Q. Then I guess I still don't 2 understand why a separate IND was not filed? 3 A. It would be a separate NDA, not 4 a separate IND. That's an investigational new 5 drug. A separate NDA wasn't filed because under 6 the regulatory requirements, the regulations did 7 not require that an entire new NDA be filed for 8 the bulimia indication, so we supplemented the 9 depression information that they had with all the 10 new information that we knew about bulimia 11 nervosa. It doesn't mean that bulimia nervosa is 12 an approved indication yet. 13 Q. Is it because the FDA considers 14 depression and bulimia closely enough related as 15 far as disease process goes to be able to rely on 16 the depression data in coming to a decision with 17 regards to bulimia? 18 A. No, it has nothing to do with 19 that. 20 Q. Was a separate IND filed on the 21 OCD? 22 MR. MYERS: IND? 23 Q. Was a separate IND filed or a 24 separate NDA filed with regards to OCD? Page 218 1 A. Yes. 2 Q. Why was there a separate IND 3 filed on Lovan? 4 A. I don't know. 5 Q. Because there's no difference 6 in the compound that constitutes Fluoxetine 7 Hydrochloride for the use in antiobesity as there 8 is in the compound that's used for depression, is 9 there? 10 A. That's a regulatory scientist 11 question from their realms of expertise as to why 12 the separate was filed or not filed. 13 Q. My question is, to your 14 knowledge, there is no difference in the 15 Fluoxetine Hydrochloride compound as it applies 16 to antiobesity as opposed to depression? 17 A. That's correct. 18 Q. It's the same drug? 19 A. That's correct. 20 Q. At the bottom, left-hand 21 corner, that's your initials and last name, 22 right? 23 A. I'm sorry, that's correct. 24 Q. Okay. What are those numbers Page 219 1 underneath that MC676, et cetera? 2 A. That's the department number. 3 Q. And the number next to that? 4 A. That's my telephone extension. 5 Q. This looks like it's a form of 6 sorts; is that correct? 7 A. That's right. 8 Q. Why is your name at the bottom 9 left-hand corner of the form? 10 A. Because I'm the department head 11 of the department that sent these forms out for 12 all of our drugs, I was at the time in November 13 of '92. 14 Q. Okay. Who's Robert Brown? 15 A. Robert Brown is a research 16 physician, I believe he's a director of the Lilly 17 Clinic. 18 Q. To your knowledge, does he work 19 on Fluoxetine? 20 A. I believe he's the director 21 over all the drugs. 22 Q. Is this his handwriting on the 23 bottom right hand corner to your knowledge? 24 A. I don't know whose handwriting Page 220 1 it is, I don't recall ever seeing Doctor Brown's 2 handwriting. 3 Q. Do you know of any clinical 4 pharmacologists at Lilly that work on Fluoxetine? 5 A. Yes. 6 Q. Can you give me some of their 7 names? 8 A. I believe Rich Bergstrom. 9 Q. Anybody else? 10 A. I don't know what Ray Fuller's 11 exact title is. 12 Q. How about David Wong? 13 A. Yes. 14 Q. Doctor Zerbe? 15 A. No, he's not a clinical 16 pharmacologist. 17 Q. Brian Mulloy? 18 A. I don't know who that is. 19 Q. Bruce Mulloy? 20 A. I don't know. 21 Q. Do you know any Doctor Mulloy 22 at Lilly? 23 A. No, I don't. 24 MR. MYERS: Ask her if she knows a Page 221 1 Robert Taylor. 2 Q. Do you know a Robert Taylor? 3 A. Yes. 4 Q. Which one? 5 MS. ZETTLER: Do you know a Walter 6 Beckham? 7 MR. MYERS: Do I? 8 MS. ZETTLER: Uh-huh. 9 MR. MYERS: I know the name. 10 Q. Have you ever heard of an 11 article called Fluoxetine Not Associated With 12 Suicidality In International Controlled Clinical 13 Trials On Depression? 14 A. Yes, I believe I have. 15 Q. Is it your understanding that 16 that was an article written by Doctor Beasley? 17 A. I don't know who wrote it. 18 Q. Was that -- do you know if that 19 was somebody, an article that was written by 20 somebody at Lilly? 21 A. Yes, I believe it was. 22 Q. Was that article ever 23 published? 24 A. I don't know. Page 222 1 Q. What's the Midwestern AFCR 2 published abstract? 3 A. I don't know 4 (PLAINTIFFS' EXHIBIT NO. 4 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 MR. MYERS: Any particular one you want 8 her to look at. 9 MS. ZETTLER: On the bottom right-hand 10 corner, I'm sorry, I know it's really hard to 11 read. 12 A. Oh. 13 Q. Have you a chance to review 14 Exhibit 4? 15 A. What I can read of it, yes. 16 Q. Does that refresh your 17 recollection as to what a Midwestern AFCR 18 published abstract is? 19 A. No, I have never seen this 20 before. 21 Q. Okay. Do you recognize the 22 information contained in the paragraph in the 23 lower righthand corner of the page? 24 A. No, I don't recognize that at Page 223 1 all. 2 Q. Earlier when you were looking 3 at this you said oh, like it jogged something in 4 your memory, what was that about? 5 A. Well, what I did is this was 6 W.L. Thompson and not my initials on this 7 abstract. 8 Q. So somebody pulled it thinking 9 that it was something from your file and it was 10 something from Leigh Thompson's file? 11 A. Leigh Thompson's file. 12 Q. Does it refresh your 13 recollection as to whether or not that article 14 was published? 15 A. No, it doesn't, I don't know. 16 Q. What is your understanding of 17 the Lilly drug dictionary? 18 A. Are you referring to the 19 COSTART Dictionary? 20 Q. My understanding is that there 21 are two, a drug dictionary and the ELECT 22 dictionary or COSTART dictionary; is that true? 23 A. That's my understanding, yes. 24 Q. What's the drug dictionary? Page 224 1 A. It's a dictionary that lists 2 different drug -- different drugs. 3 Q. Okay. 4 A. Generic names and trade names 5 of the drug. 6 Q. And the ELECT dictionary is a 7 dictionary developed by Lilly which contains 8 adverse event terms? 9 A. It contains adverse event 10 terms, I'm not aware of who developed it. 11 Q. At any point in time were you 12 aware of the ELECT dictionary being revised? 13 A. I don't recall it being 14 revised, I don't remember. 15 MS. ZETTLER: I'm going to show this to 16 her without marking it. Is that okay? That will 17 save some time. 18 Q. I've just shown you a letter 19 dated February 2, 1990, correct? 20 A. Uh-huh. 21 MR. MYERS: Yes. 22 A. Yes. 23 Q. And at the bottom is your 24 signature? Page 225 1 A. Yes. 2 Q. Does that refresh your 3 recollection at all about revision of the ELECT 4 dictionary? 5 A. Yes. 6 Q. Could you tell me about that 7 revision? 8 A. Well, it appears that the ELECT 9 dictionary was revised, and what this letter is 10 is a letter that I sent out to the clinical 11 investigators along with a new version -- a new 12 version of the dictionary. 13 Q. Okay. Do you recall what 14 revisions were made to the ELECT dictionary at 15 that time? 16 A. No, I don't. 17 Q. Do you recall any other times 18 the ELECT dictionary being revised in addition to 19 this time? 20 A. I don't recall, no. 21 Q. Was it a policy at Lilly to 22 submit clinical investigation brochures to the 23 FDA? 24 A. Yes. Page 226 1 Q. Was that because of the FDA 2 regulations? 3 A. Yes, I believe it is. 4 Q. Is that done on a regular basis 5 or is that something that's done like if you're 6 going to -- if you revise your brochure, you send 7 it to the FDA? 8 A. It's done on a regular basis, 9 the CIB is reviewed at every annual report time 10 by a research physician to make the decision as 11 to whether it needs to be updated. 12 Q. Okay. What ways would the CIB 13 be updated? 14 A. It would be updated with any 15 new information that we've known about the drugs 16 since the last time it was updated. 17 Q. Would that include new 18 information on adverse events? 19 A. Yes. 20 Q. Study HCEQ, a project that -- 21 HCEQ, was that a bulimia study? 22 A. Yes, it was. 23 Q. Do you recall a site where the 24 clinical investigators didn't feel that events Page 227 1 from the drug diaries needed to be listed in the 2 clinical report forms? 3 A. Diaries, are you referring to 4 the diary of binging and purging? 5 MS. ZETTLER: I will mark this as 6 exhibit. 7 (PLAINTIFFS' EXHIBIT NO. 5 WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 Q. Have you had a chance to review 11 it, Exhibit 5? 12 A. Yes, I have. 13 Q. Are you familiar with the 14 subject matter of that? 15 A. Yes, I am. 16 Q. Can you tell me about the 17 subject matter? 18 A. What this is is one of our 19 field people, our CIRs has gone in to audit and 20 has on the audit found events and drugs in the 21 diary of binging and purging and progress notes 22 that weren't listed on the CRF and she's auditing 23 them and saying that they needed to be listed. 24 Q. What are the work sheets that Page 228 1 she's talking about in the third line of the 2 major part of the text there? 3 A. This trial was a CTM trial, a 4 computer trial management trial, and because of 5 that, there are no paper case report forms and 6 they have work sheets that they -- they had work 7 sheets that they used as they sat down to enter 8 the information into the computer that were at 9 the site and those were the work sheets she's 10 referring to. 11 Q. At the bottom there it says 12 mail almedica, what's an almedica? 13 A. That's a pouch that in case of 14 an emergency, it contains what drug the patient 15 is on, either the drug or the placebo for the 16 comparitor and emergency almedica, label can be 17 opened by the site immediately so the physician 18 at the site will know what drug the patient is 19 on. 20 Q. So the almedica contains the 21 randomizations? 22 A. Yes it does. 23 Q. And that's sent to the site? 24 A. The almedica is at the site and Page 229 1 it's stuck on the actual bottle or container of 2 the pill. It's sealed so it can't be opened and 3 numbered and what this is referring to is at the 4 end of the trial when a patient drops from the 5 study, that almedica labels are sent back to 6 Lilly. 7 Q. Why is the almedica sent to the 8 site? 9 A. Because the site needs the 10 clinical -- the physician, research physician or 11 study coordinator, if a patient has an event and 12 they needed to know immediately what drug the 13 patient was on, they could open that up and find 14 out what drug the patient was on so they could 15 medically treat them. 16 Q. Have you ever heard of a CTE 17 form or a CTE study? 18 A. CTE? 19 Q. Yes. 20 A. No, that doesn't ring any 21 bells. 22 Q. How about a quarterly report 23 form? 24 A. I don't recall what that is. Page 230 1 (PLAINTIFFS' EXHIBIT NO. 6 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. Do you recognize exhibit 6? 5 A. Yes, I do. 6 Q. Can you tell us what that is? 7 A. It's a quarterly report form 8 that this particular site would have sent to 9 update their internal review board, their IRP 10 quarterly. 11 Q. So it's a report form that goes 12 to the IRB and not to Lilly? 13 A. That's right, and they 14 evidently have copied Lilly, it's one of their 15 internal forms, it's not a Lilly form. 16 Q. At the bottom it says 17 distribution and white indicates to somebody 18 yellow monitor, and pink investigator. Do you 19 know where the white copy -- where the white copy 20 would have gone? 21 A. No. 22 Q. Okay. Towards the top it says 23 sponsor slash protocol? 24 A. Yes. Page 231 1 Q. Looks like Lilly PR period, is 2 that correct? 3 A. Uh. 4 Q. Or could that be a Z? 5 A. I bet it's a Z, that's a bet. 6 Q. Okay. That Pz is generally to 7 indicate Prozac, right? 8 A. That's correct. 9 Q. And then what is it, B 1 10 ampersand slash, MC? 11 A. That's a code of B 1 Y is the 12 broad name of the group of medications, MC means 13 McCarty, which means it's done at that -- the 14 trial's being done at Lilly headquarters and HCEQ 15 is the protocol identifier. So that string of 16 numbers is the protocol identifier. 17 Q. So this is a study that's being 18 done at Lilly headquarters? 19 A. Yes, that's where it 20 originates, yes, that's where it's being 21 monitored. 22 Q. Being monitored, not being 23 performed? 24 A. That's correct. Page 232 1 Q. Does this indicate to you what 2 indication this trial was being done on? 3 A. Yes, it does. 4 Q. Which indication? 5 A. Bulimia nervosa. 6 Q. So that should be B 1 Y instead 7 of ampersand? 8 A. That's right. 9 Q. Have you ever heard of 10 ancillary study? 11 A. Yes, I believe I've heard that 12 word. 13 Q. Okay. What's an ancillary 14 study? 15 A. If it's what I think -- if it's 16 the way that I think I should interpret it, it's 17 a study that an investigator is doing on their 18 own -- well, in conjunction with the Lilly 19 sponsored study. 20 Q. To your knowledge was there 21 ever an ancillary study done with regards to 22 Prozac for -- or Fluoxetine for an individual 23 indication where ancillary studies were done for, 24 like suicidality? Page 233 1 A. Not to my knowledge. 2 Q. How about anxiety? 3 A. Not to my knowledge. 4 Q. Earlier you testified that you 5 were involved with the Beasley meta-analysis 6 article, correct? 7 A. That's correct. 8 Q. Can you tell us generally what 9 your involvement was with that, with the 10 preparation of that article? 11 A. Collecting information, 12 bringing it in from warehouses. My specific role 13 was coordinating the efforts to review the data. 14 Q. What do you mean bringing in 15 information from the warehouses? 16 A. It's in secured area, all the 17 case report forms on not current trials but very 18 old trials would have been at one of our stores, 19 warehouse. 20 Q. Is it correct that the 21 meta-analysis was done -- for the purpose of this 22 article was done on double blind controlled U.S. 23 conducted studies on depression? 24 A. I believe so. Page 234 1 Q. Were any of those studies not 2 on computer -- results of the data from that 3 study was not on computer or was it all on 4 computer? 5 A. I believe it was all on 6 computer. 7 Q. Okay. 8 A. Of one sort or another. 9 Q. I'm assuming that the 10 information you brought in from the warehouses 11 was hard copy CRF? 12 A. That's right. 13 Q. Any other information besides 14 the hard copy CRF that were brought in from the 15 warehouses? 16 A. No. 17 Q. Why would you bring the CRFs in 18 from the warehouse if the information from the 19 CRFs was already in the data base? 20 A. If the information -- when the 21 information was in the data base, and we wanted 22 to look at what was actually written or had any 23 question at all of what we were looking at, we 24 looked at the hard copy, we looked at the paper. Page 235 1 Q. So if you had a question as to 2 what was contained in the data base, you would 3 look at the hard copy? 4 A. That's correct. 5 Q. That was already done at one 6 point in time, wasn't it, though, before the 7 information was stored in the data base? 8 A. That's right, but we were 9 looking at every Fluoxetine trial from the time 10 the trial started. So it was before a lot of 11 this, a lot of us were not the people that had 12 done it, we were just looking again. 13 Q. Is there any reason not to 14 trust the people who had worked on the 15 information prior to your working on the 16 information? 17 A. No, no reason. 18 Q. Was this something that was 19 done before a decision was made to concentrate on 20 the double blind controlled studies? 21 MR. MYERS: Was what done? 22 MS. ZETTLER: The review of all these 23 CRFs from all the studies. 24 A. I don't know when that decision -- Page 236 1 I wasn't a part of that decision, I don't know 2 when that decision was made. 3 Q. The CRFs that were brought in 4 from the warehouses, were they the CRFs for every 5 single study that was done on Fluoxetine to date? 6 A. Yes. 7 Q. For any indication whatsoever? 8 A. Yes, I believe so. 9 Q. At some point in time, the 10 decision was made just to concentrate on the 11 double blind controlled studies for depression, 12 correct? 13 A. Yes. 14 Q. Do you know what the reason was 15 to concentrate on just that limited information? 16 A. No, I don't. 17 Q. What else did you do with 18 regards to the paper? 19 A. My role in that was to bring 20 the paper in to coordinate the review, who was 21 reviewing what, that type of coordination. That 22 was my role in that effort. 23 Q. Okay. To your knowledge, was 24 only specific information contained in the CRFs Page 237 1 reviewed or were the entire CRFs reviewed? 2 A. To my knowledge, the entire 3 CRFs were reviewed. 4 Q. And they were all double 5 checked against the data that was contained in 6 the data base? 7 A. No. 8 Q. No, okay, I'm getting confused 9 again. Why was all the information reviewed to 10 start with? 11 A. All the information was 12 reviewed -- well, let me back up, I'm getting 13 tired too. What was done is we looked at the 14 computer data bases. 15 Q. Okay. 16 A. If we had any questions about 17 anything that was in the computer data base, then 18 we would look on the paper to clarify our 19 questions. 20 Q. So it wasn't a matter of 21 starting off by reviewing every single CRF for 22 the information that was contained, it was a 23 matter of having the CRFs available to you if you 24 had a question as to what was contained on the Page 238 1 computer data base? 2 A. Yes. 3 Q. Did you have any writing 4 responsibilities with regards to the article? 5 A. I don't think so. 6 Q. Would looking at a copy of the 7 article refresh your recollection as to whether 8 or not you had any writing responsibilities? 9 A. I remember working with the 10 writer, with January Potvin. 11 Q. I'm sorry, go ahead, I didn't 12 mean to cut you off. 13 A. Reviewing, editing type. I 14 don't remember writing text. 15 Q. Okay. Did you have any 16 responsibilities for setting up the tables that 17 were part of the article in the appendix? 18 A. It would help me to look at the 19 tables. 20 (PLAINTIFFS' EXHIBIT NO. 7 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 A. I believe that I helped set up 24 the table that is on -- the table 2 on page 688. Page 239 1 Q. Okay. Any others? 2 A. That's the only one that looks 3 familiar. 4 Q. Is this the table that was set 5 up specifically for this paper or was this a 6 table that had been set up for some other purpose 7 previously? 8 A. I don't remember. 9 Q. Does this refresh your 10 recollection as to whether or not you had any 11 specific responsibility to write any portion of 12 the paper other than setting up the table? 13 A. I might have worked on the text 14 around the table, the description of the table, 15 but I don't specifically know that. 16 Q. Okay. When you say the text, 17 you mean the part that says table 2 incidents of 18 suicidal acts, et cetera? 19 A. Yes. 20 Q. Any other responsibilities you 21 had with regards to the preparation of this 22 article? 23 A. No. 24 Q. Any responsibilities that you Page 240 1 had with regards to the publication of this 2 article, for instance contacting the Journal or 3 anything like that? 4 A. No. 5 Q. To your knowledge, what was the 6 publication process that this article went 7 through, in other words, was this drafted and 8 then submitted to the British Medical Journal or 9 was there some other way, some other practice 10 that Lilly went through with regards to 11 publishing? 12 A. It was drafted and after the 13 draft then I wasn't any part with submitting it 14 to any publishers after that. After the draft 15 was written and revised, meaning corrected, 16 edited, approved, then I didn't have any part 17 with the submission to a journal. 18 Q. Okay. And I think I asked you 19 earlier whether or not it was ever published in 20 another journal besides the British Medical 21 Journal, right? 22 A. Uh-huh. 23 Q. And I forgot what your answer 24 was? Page 241 1 A. I don't believe so, I don't 2 remember it being published, I don't believe so. 3 Q. Did Lilly ever consider 4 publishing it in another journal after this came 5 out in the British Medical Journal? 6 A. I wasn't aware or a part of any 7 discussions about the publication of the paper. 8 Q. Were you aware that there was a 9 controversy about the validity of the paper after 10 it was published in the British Medical Journal? 11 MR. MYERS: Let me object to the form 12 and the use of the term controversy as being 13 awfully vague and a controversy among or between 14 whom or who? 15 Q. Were you aware of whether or 16 not there was some one person or other people 17 that questioned the validity of this article 18 after this was published in the British Medical 19 Journal? 20 A. Yes. 21 Q. What do you know about the 22 situation? 23 A. I believe that the Church of 24 Scientology challenged the validity of the paper. Page 242 1 Q. Besides the Church of 2 Scientology, anybody else? 3 A. Not that I remember. 4 Q. Do you know of a Doctor Oswald? 5 A. No. 6 Q. Do you know if Doctor Oswald 7 was related in any way to the Church of 8 Scientology? 9 A. I don't know of a Doctor 10 Oswald. 11 Q. Are you aware that there were 12 letters to the editor after this article appeared 13 questioning the validity of some of the 14 conclusions that were drawn in the article? 15 A. I don't remember that. 16 Q. Do you remember what was done 17 by Lilly if anything in response to the Church of 18 Scientology challenges of the validity of the 19 conclusions drawn in the article? 20 A. No, I don't know. 21 Q. Do you have any responsibility 22 related to the publication of any articles in the 23 public press, popular press as opposed to medical 24 journals or things of that nature? Page 243 1 A. No. 2 MS. ZETTLER: Can I take ten minutes 3 and review my notes? 4 MR. MYERS: Sure. 5 (A SHORT RECESS WAS TAKEN.) 6 Q. Did I ask you earlier about 7 whether or not you were aware of a rechallenge 8 study on movement disorders? 9 A. Yes, you did. 10 MR. MYERS: On movement disorders, I 11 don't remember, you asked her about rechallenge. 12 MS. ZETTLER: Right. 13 MR. MYERS: I remember the subject of 14 rechallenge and the separate subject of movement 15 disorders, I don't know whether you -- 16 Q. Your answer was you were not 17 aware of any rechallenge studies that were done 18 on movement disorders? 19 A. That's correct. 20 Q. Were you or are you aware of 21 any studies that were done with Fluoxetine and 22 movement disorders as an indication? 23 A. No, I was not aware of any 24 studies like that. Page 244 1 Q. Were you aware of any studies 2 done with Fluoxetine whatsoever related to 3 movement disorders? 4 A. No, I'm not aware of any. 5 Q. Did anybody die during the 6 obesity trials to your knowledge, any of the 7 volunteers? 8 A. I don't know, not to my 9 knowledge, I don't know. 10 Q. How about the OCD trials? 11 A. I don't believe anyone died in 12 the OCD trials. 13 Q. How about smoking? 14 A. I don't know anything about the 15 smoking trials. 16 Q. Alcoholic trials? 17 A. I don't know. 18 Q. Let me ask you a couple more 19 questions about the data that existed in the data 20 base, okay, the various data bases. Let's start 21 with the data bases that contain the CRF. 22 A. All right. 23 Q. With regards to the Advisory 24 Committee Meeting information that you retrieved Page 245 1 from the data base, the information that was 2 retrieved and given to Doctor Beasley I believe 3 to review for suicidal ideation or suicidality. 4 A. Yes. 5 Q. That had already been reviewed 6 by people previously with regards to whether or 7 not the incidents reported in those CRFs were 8 actually suicidal acts or suicidal ideation, 9 correct? 10 A. Yes. 11 Q. Are you aware that at a certain 12 point in time data bases related to the various 13 clinical trials are locked? 14 A. Yes. 15 Q. And that is so nobody can get 16 back in and change the information that's in 17 there? 18 A. That's correct. 19 Q. And before the information in 20 the data base is locked or the data base itself 21 is locked, a clinical research physician has 22 already reviewed that information to make a 23 determination as to whether or not the adverse 24 event fits certain criteria like serious events, Page 246 1 expected, et cetera, correct? 2 A. Yes. 3 Q. Okay. And part of that process 4 before the data base is locked originally, would 5 be a determination as to whether or not any given 6 adverse event that is determined somewhere down 7 the line to be a suicidal act, is in fact a 8 suicidal act, correct? 9 MR. MYERS: I object to the form only 10 because I don't understand the question. I mean 11 it's awfully vague. If you understand it go 12 ahead but it's awfully convoluted. 13 A. The way that I understand it, 14 and let me know if this is what you meant, is 15 that a physician -- one of the physicians would 16 have looked at the event that was labeled suicide 17 act and made a determination as to whether it was 18 indeed a suicide act. 19 Q. Right. 20 A. If it were labeled a suicide 21 act by the clinical investigator. 22 Q. Okay. 23 A. Then one of our physicians 24 wouldn't have changed that labeling, is that what Page 247 1 you're asking me or -- 2 Q. No, what I'm asking is if a 3 determination -- let me ask it this way: Are 4 adverse events reported on the CRFs reviewed by 5 personnel in the DEU? 6 A. No. 7 Q. Okay. Are they reviewed by 8 Lilly employees such as CRAs? 9 A. Yes. 10 Q. Okay. And if a CRA -- take as 11 an example say an investigator reports that one 12 of the patients took an overdose of Imipramine 13 during a clinical trial, okay? 14 A. Okay. 15 Q. Somebody would make a 16 determination at some point whether or not that 17 overdose was an accidental overdose or an 18 intentional overdose, correct? 19 A. That's correct. 20 Q. And that would be done -- a 21 determination would be done before the 22 information on that event was locked in the data 23 base, correct? 24 A. Yes. Page 248 1 Q. Okay. So the information that 2 you pulled and gave to Doctor Beasley and Doctor 3 Wheadon to review was information that had 4 already been locked in the data base at some 5 point, correct? 6 A. That's right. 7 Q. So it had already been reviewed 8 by a clinical research physician at Lilly to make 9 a determination as to whether or not it was an 10 intentional overdose as opposed to an accidental 11 overdose? 12 A. Yes. 13 Q. They were making an additional 14 determination based on their own clinical 15 judgment as to whether or not they felt that any 16 given event was using that example, an 17 intentional overdose as opposed to accidental 18 overdose? 19 A. They were making that 20 determination in conjunction with the 21 investigator at the site with the information 22 that the investigator at the site provided. 23 Q. Additional information as to -- 24 information in addition to what was already Page 249 1 reviewed by the original clinical research 2 physician who reviewed the report before the 3 information was locked in the data base? 4 A. No, before the information was 5 locked, it would have been determined accidental 6 or intentional. 7 Q. Right, that's -- 8 A. That's right. 9 Q. I guess what I'm asking is, say 10 you have ten clinical report forms in the data 11 base, okay, the information is in the data base, 12 the information has already been reviewed and the 13 data base has been locked. 14 A. Uh-huh. 15 Q. My understanding is, after the 16 fact, it was your job to go through that data 17 base and pull or flag somehow all of those 18 incidents that were either termed or appeared to 19 you to be related to suicidality? 20 A. That's correct. 21 Q. Okay. But a determination had 22 already been made by somebody else earlier in the 23 process as to whether or not a given event was 24 related to suicidality or was like for instance Page 250 1 an accidental overdose or something along those 2 lines, correct? 3 A. Yes. 4 Q. And then Doctor Beasley and 5 Doctor Wheadon looked at that information again 6 and applied their own clinical judgment with 7 regards to each one of those situations to 8 determine whether or not in their judgment it was 9 actually an accidental overdose as opposed to an 10 intentional overdose, using that example again? 11 MR. MYERS: I object to the form 12 because I think in your example, you omitted some 13 of her prior testimony on this very subject in 14 terms of the role of, for example, the clinical 15 investigator which she incorporated in an answer 16 a couple of minutes ago. 17 MS. ZETTLER: That's what I'm trying to 18 find out. I then asked her whether or not Doctor 19 Beasley and Doctor Wheadon went back to the 20 clinical investigator in effect and asked them 21 for additional information about any given 22 events. 23 Q. Is that your understanding or 24 did they just review what was already in the data Page 251 1 base to make their own judgment as to how to 2 categorize, for lack of a better phrase, an 3 individual event? 4 A. What they were doing is using 5 the event that was in the data base. 6 Q. Right. 7 A. I'm not sure what they were 8 doing with it. 9 Q. Okay. 10 A. From -- I don't know, I'm just 11 not sure what they were doing with it once they 12 got it. 13 Q. Is it your understanding that 14 they made additional investigations into each and 15 every one of those questions, CRFs, once you gave 16 them to them to review? 17 A. It's my understanding that they 18 reviewed them. What they did with them after the 19 review, I don't know. 20 Q. Okay. And did they then say to 21 you or somebody else at Lilly to your knowledge, 22 okay, we reviewed these, for example, two hundred 23 CRFs or events and these are the events that we 24 feel are not related to suicide and these are the Page 252 1 events that we feel are related to suicide and 2 this is what you do with the events that are not 3 related to suicide, put this stuff back in the 4 data base or something like that? 5 A. Yes. 6 MS. ZETTLER: That's all I have, thank 7 you. 8 MR. MYERS: Anybody else? 9 MR. RUIZ: I have no questions. 10 MS. LAWS: I have a couple of quick 11 questions. 12 * * * * * * * * * * 13 CROSS EXAMINATION 14 BY MS. LAWS: 15 Q. My name is Catherine Laws and I 16 represent some physicians in lawsuits in Texas. 17 We discussed your educational background earlier. 18 You are not a medical doctor; is that correct? 19 A. That's correct. 20 Q. And you have not attended 21 medical school? 22 A. That's correct. 23 Q. And you're not a licensed 24 physician in any state; is that correct? Page 253 1 A. That's correct. 2 MS. LAWS: Thank you, I don't have any 3 further questions. 4 MS. BRODSKY: No questions. 5 MR. CLEMENTI: No questions. 6 (THE WITNESS WAS EXCUSED.) Page 254 1 COMMONWEALTH OF KENTUCKY ) 2 : ss COUNTY OF JEFFERSON ) 3 4 I, MARY KATHLEEN NOLD, A NOTARY PUBLIC IN 5 AND FOR THE STATE OF KENTUCKY AT LARGE, DO HEREBY 6 CERTIFY THAT THE FOREGOING TESTIMONY OF 7 VICKI LEE THOMPSON 8 WAS TAKEN BEFORE ME AT THE TIME AND PLACE AS 9 STATED IN THE CAPTION; THAT THE WITNESS WAS FIRST 10 DULY SWORN TO TELL THE TRUTH, THE WHOLE TRUTH, 11 AND NOTHING BUT THE TRUTH; THAT THE SAID 12 PROCEEDINGS WERE TAKEN DOWN BY ME IN STENOGRAPHIC 13 NOTES AND AFTERWARDS TRANSCRIBED UNDER MY 14 DIRECTION; THAT IT IS A TRUE, COMPLETE AND 15 CORRECT TRANSCRIPT OF THE SAID PROCEEDINGS SO 16 HAD; THAT THE APPEARANCES WERE AS STATED IN THE 17 CAPTION. 18 WITNESS MY SIGNATURE THIS THE 3RD DAY OF 19 SEPTEMBER, 1993. 20 MY COMMISSION EXPIRES MARCH 10, 1994. 21 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 255 1 2 3 E R R A T A S H E E T 4 5 STATE OF INDIANA ) : SS 6 COUNTY OF ) 7 8 I, VICKI THOMPSON, THE UNDERSIGNED 9 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 10 OF MY DEPOSITION AND WITH THE CHANGES NOTED 11 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 12 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 13 THE AUGUST 18, 1993 AT THE TIME AND PLACE STATED 14 THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 256 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 VICKI THOMPSON 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 INDIANA AT LARGE Page 257 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Page 260