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: IRWIN SLATER 11 DATE: JANUARY 28 AND 29, 1994 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 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 * * * * * * * * * * Page 2 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 3 1 CAUSE NO. 92-14775-E 2 RICHARD HAROLD CROSSETT, JR. : IN THE DISTRICT CHAD H. CROSSETT, AMY MICHELLE : COURT OF 3 CROSSETT, AND KRISTIN ANN : CROSSETT, INDIVIDUALLY AND AS : 4 SURVIVORS OF AND ON BEHALF OF : THE ESTATE OF JOCQUETTA ANN : 5 CROSSETT, DECEASED : : 6 VS. : DALLAS COUNTY, : TEXAS 7 ELI LILLY AND COMPANY, DISTA : PRODUCTS COMPANY, TEXAS : 8 PSYCHIATRIC COMPANY, INC. D/B/A : HCA WILLOW PARK HOSPITAL, : 9 JAMES K. WITSCHY, M.D., AND : 101ST JUDICIAL DOUG BELLAMY, ED.D. : DISTRICT 10 11 * * * * * * * * * * Page 4 1 NO. 93-8792-D 2 DAVID KUNG, DALE KUNG COHEN : IN THE DISTRICT 3 ROBERT KUNG, AND TIMOTHY KUNG : COURT OF INDIVIDUALLY AND AS SURVIVORS : 4 AND STATUTORY BENEFICIARIES : OF MAY YUN KUNG, DECEASED : 5 : VS. : DALLAS COUNTY, 6 : TEXAS ELI LILLY AND COMPANY, DISTA : 7 PRODUCTS COMPANY, AND MONIQUE : 95TH JUDICIAL KINKLE, PH.D. : DISTRICT 8 9 * * * * * * * * * * IN THE 128TH JUDICIAL DISTRICT COURT 10 ORANGE COUNTY, TEXAS 11 MARIA GUADALUPE REVES ) IN THE INDIVIDUALLY AND AS NEXT ) DISTRICT COURT 12 FRIEND OF GRANT JULIAN REVES ) OF A MINOR CHILD, AND ON BEHALF ) 13 OF THE ESTATE OF CHRISTIAN ) MARIE REVES, DECEASED ) 14 ) ORANGE COUNTY, V. ) TEXAS 15 ) ELI LILLY & COMPANY, DISTA ) 16 PRODUCTS COMPANY, RAVIKUMAR ) KANNEGANTI, M.D., HOSPITAL ) 17 CORPORATION OF AMERICA, A ) TENNESSEE CORPORATION, HEALTH ) 18 SERVICES ACQUISITION CORP., ) A DELAWARE CORPORATION, ) 19 HCA PSYCHIATRIC COMPANY, A ) DELAWARE CORPORATION, TEXAS ) 20 PSYCHIATRIC CO., INC.. A/K/A ) AND/OR D/B/A HCA BEAUMONT ) 21 NEUROLOGICAL HOSPITAL, AND HCA ) HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL 22 A/K/A AND/OR BEAUMONT ) DISTRICT NEUROLOGICAL HOSPITAL ) 23 * * * * * * * * * * Page 5 1 CAUSE NO. 93-04911-A 2 LINDA JILL WELCH, CARLINDA : IN THE DISTRICT WELCH REX, CONNAN ROSS WELCH, : COURT OF 3 AND CHAD MICHAEL WELCH, : INDIVIDUALLY AND AS SURVIVORS : 4 AND STATUTORY BENEFICIARIES : OF CARL EUGENE WELCH, DECEASED : 5 : VS : DALLAS COUNTY, 6 : TEXAS ELI LILLY AND COMPANY, DISTA : 7 PRODUCTS COMPANY, NO NEAVES, : M.D., AND MINIRTH-MEIER : 14TH JUDICIAL 8 CLINIC, P.A. : DISTRICT Page 6 1 THE DEPOSITION OF IRWIN SLATER TAKEN AT THE 2 OFFICE OF PAULICH AND O'HARA, 2150 GOODLETTE, 3 NAPLES, FLORIDA, ON JANUARY 28 AND 29, 1994; SAID 4 DEPOSITION TAKEN PURSUANT TO NOTICE IN ACCORDANCE 5 WITH THE RULES OF CIVIL PROCEDURE. 6 * * * * * * * * * * 7 A P P E A R A N C E S 8 RENE MORTIMER 9 COUNSEL FOR PLAINTIFFS LEONARD M. RING AND ASSOCIATES, P.C. 10 111 WEST WASHINGTON AVENUE, SUITE 1333 CHICAGO, ILLINOIS 60602 11 STEPHEN LORE 12 COUNSEL FOR ELI LILLY AND COMPANY FREEMAN & HAWKINS 13 4000 ONE PEACHTREE CENTER 303 PEACHTREE STREET, N.E. 14 ATLANTA, GEORGIA 30308-3243 15 MARGARET M. HUFF ELI LILLY AND COMPANY 16 LILLY CORPORATE CENTER INDIANAPOLIS, INDIANA 46285 17 JAMES L. ARMSTRONG, III 18 COUNSEL FOR DEPONENT KELLEY DRYE & WARREN 19 2400 MIAMI CENTER 201 SOUTH BISCAYNE BOULEVARD 20 MIAMI, FLORIDA 33131 Page 7 1 2 PAUL SMITH 3 COUNSEL FOR PLAINTIFFS 745 CAMPBELL CENTER 2 4 8115 NORTH CENTRAL EXPRESSWAY DALLAS, TEXAS 75206 5 BEATRICE M. SMITH 6 COUNSEL FOR BEAUMONT NEUROLOGICAL HOSPITAL FRIEND & ASSOCIATES, LLP 7 1301 MCKINNEY, SUITE 2900 HOUSTON, TEXAS 77010 8 Page 8 1 I N D E X 2 3 DEPOSITION OF IRVIN SLATER 4 5 DIRECT EXAMINATION BY MR. SMITH 10 6 CONTINUED EXAMINATION BY MR. SMITH 250 7 8 CERTIFICATE 440 9 ERRATA 441 10 11 CERTIFIED QUESTIONS 12 QUESTIONS CERTIFIED 250 QUESTION CERTIFIED 317 13 QUESTION CERTIFIED 386 14 EXHIBITS 15 PLAINTIFFS' EXHIBIT NO. 1 56 PLAINTIFFS' EXHIBIT NO. 2 126 16 PLAINTIFFS' EXHIBIT NO. 3 243 PLAINTIFFS' EXHIBIT NO. 4 328 17 PLAINTIFFS' EXHIBIT NO. 5 330 PLAINTIFFS' EXHIBIT NO. 6 352 18 PLAINTIFFS' EXHIBIT NO. 7 357 PLAINTIFFS' EXHIBIT NO. 8 362 19 PLAINTIFFS' EXHIBIT NO. 9 370 PLAINTIFFS' EXHIBIT NO. 10 376 20 PLAINTIFFS' EXHIBIT NO. 11 387 PLAINTIFFS' EXHIBIT NO. 12 411 Page 9 1 2 3 COMES DR. IRWIN SLATER, CALLED BY 4 THE PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, 5 WAS DEPOSED AND TESTIFIED AS FOLLOWS: 6 MR. SMITH: Before we begin, why don't 7 we go ahead and recite the usual agreements that 8 we have been conducting these depositions under 9 with respect to objections and form and filing. 10 I assume they're going to be the same as in the 11 other depositions. And, Steve, you have some 12 other additional? 13 MR. LOWER: It's my understanding for 14 the purposes of Doctor Slater's deposition and 15 the case for which you noticed the deposition and 16 for which Lilly noticed the deposition, that you 17 agreed to be bound by the terms of the 18 confidentiality order entered in the M.D.L. 19 litigation. 20 MR. SMITH: That's correct. 21 * * * * * * * * * * 22 DIRECT EXAMINATION 23 BY MR. SMITH: 24 Q. Would you state your name? Page 10 1 A. Irwin Slater. 2 Q. I believe you told us off the 3 record, Doctor Slater, that you are seventy-six 4 years old? 5 A. Yes. 6 Q. May I have your residence 7 address, please. 8 A. XXXXXXXXXXXXXXXXXXXXXXXXX 9 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. 10 Q. And how long have you lived at 11 that address? 12 A. XXXXXXXXXXXXXX. 13 Q. Does anyone live with you at 14 that address? 15 A. No. 16 Q. Are you a widower, divorced? 17 A. Yes, a widower. My wife died 18 three years ago. 19 Q. Do you have children, Doctor? 20 A. Two. 21 Q. Where do they live? 22 A. I have a daughter in -- XXXX 23 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 24 XXXXXXXXXXXXXXXXXXXXX. Page 11 1 Q. And I assume they're grown and 2 have been gone for years? 3 A. Yes. 4 Q. Have you for the XXXXXXXXXXXXXX 5 XXXXX continuously lived permanently here in 6 XXXXXXXXXXXXXXX? 7 A. Yes. 8 Q. What was your address before 9 you moved to XXXXXXXX, Doctor Slater? 10 A. XXXXXXXXXXXXXXXXXXXXXXX 11 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. 12 Q. And do you recall how long you 13 lived there, Doctor Slater? 14 A. At that address, about 15 XXXXXXXXXXXXXXXX. 16 Q. Are you currently employed? 17 A. No. 18 Q. When were you last employed? 19 A. Formerly full-time my last 20 employment was with Eli Lilly and Company and I 21 retired at the end of 1979. I did have a part 22 time responsibility as editor of Clinical and 23 Experimental Hypertension for which I was paid a 24 pittance and I resigned from that position about Page 12 1 two years ago. 2 Q. Is Clinical And Experimental 3 Hypertension a scientific publication? 4 A. Yes. 5 Q. And where is that published? 6 A. New York. 7 Q. By whom? 8 A. Decker. 9 Q. Is it a periodical? 10 A. Yes. 11 Q. How often is it published? 12 A. Most years there's published 13 about six issues per year but occasionally more, 14 as much as twelve. 15 Q. How long were you on the 16 editoral staff of that publication? 17 A. About twelve years. 18 Q. Did you join that after you 19 retired from Lilly? 20 A. Yes. 21 Q. What was your reason for that 22 endeavor? 23 A. I wanted to continue my 24 contact with science and this gave me an Page 13 1 opportunity to review papers from people who were 2 doing research in areas in which I had some 3 interest. 4 Q. And you would, as part of your 5 duties, receive publications that had been 6 submitted for, or articles that had been 7 submitted for publication in that journal and you 8 would review those articles for scientific 9 purposes? 10 A. Yes. 11 Q. And make a decision concerning 12 whether or not they should be published? 13 A. After obtaining opinion from 14 reviewers who were more expert than I in the 15 specialized field. 16 Q. Were you the editor in chief 17 or on the board of editors? 18 A. I was the editor in chief. 19 Q. For that entire period of 20 time? 21 A. Yes. 22 Q. Was that journal in 23 publication prior to your becoming editor in 24 chief? Page 14 1 A. Yes. 2 Q. Is it still in publication? 3 A. Yes. 4 Q. You are a medical doctor, is 5 that correct? 6 A. Yes. 7 Q. Would you tell us, Doctor 8 Slater, what your educational background is 9 beginning with high school, where you graduated 10 from high school and when and bring us through? 11 A. I'm proud to do that. I was 12 graduated from Erasmus Hall High School in 13 Brooklyn, New York, which high school was founded 14 in 1787. I attended the University of Virginia 15 in Charlottesville where I obtained a Bachelors 16 Degree in 1937; New York University College of 17 Medicine, an M.D. in 1941. My education 18 continued in the sense as I interned at Beth 19 Israel Hospital in New York, 1941 to 1942. I was 20 in the United States Navy from 1942 through 1946. 21 In 1946 I returned as a resident in medicine at 22 Beth Israel Hospital and a part-time instructor 23 in pharmacology at New York University College of 24 Medicine. After completing the residency, I Page 15 1 practiced medicine in New York and became an 2 instructor in pharmacology at NYU. From 1949 3 through 1954 I was instructor and assistant 4 professor of pharmacology at the University of 5 Rochester. At various times I was a visiting 6 professor at Indiana University and the 7 University of Illinois in Chicago. 8 Q. Do you have a curriculum 9 vitae? 10 A. What? 11 Q. Do you have a C.V. or anything 12 of that nature with you? 13 A. No. 14 Q. Let me -- did you complete 15 your educational background? 16 A. I think so. 17 Q. Let me see if I can get these 18 dates and times and locations straight. 19 A. Okay. 20 Q. You graduated from Erasmus 21 Hall High School in Brooklyn in what year? 22 A. I guess 1934. 23 Q. Then you received your 24 bachelors degree at the University of Virginia in Page 16 1 1937? 2 A. Yes. 3 Q. And the University of Virginia 4 at Charlottesville? 5 A. Yes. 6 Q. Bachelor of science? 7 A. Yes. 8 Q. What was your major? 9 A. Chemistry and biology, I was a 10 premed student. 11 Q. And you were at the -- when 12 did you graduate from the University of Virginia? 13 A. 1937. 14 Q. And then immediately began 15 medical school at New York College of Medicine? 16 A. New York University, it's 17 important, because there's a New York College of 18 Medicine which is less prestigious in my opinion. 19 Q. You received your M.D. degree 20 in 1941? 21 A. Yes. 22 Q. Then did an internship at Beth 23 Israel Hospital? 24 A. Yes, one year. Page 17 1 Q. From 1941 to 1942, is that 2 correct? 3 A. Uh-huh, yes. 4 Q. Then were you a physician in 5 the U.S. Navy? 6 A. Yes. 7 Q. And that was during the war? 8 A. Yes. 9 Q. Where were you stationed? 10 A. You really want to know? I'll 11 go through it in detail. 12 Q. Was it overseas? 13 A. I was with -- 14 MR. ARMSTRONG: He just wants to know 15 whether you were overseas. 16 A. I was with an LCT flotilla in 17 North Africa, Sicily, Salerno and then in 18 England, Normandy and so on. 19 Q. You were around combat but you 20 were treating soldiers? 21 A. Yes. Actually I was around 22 combat in Sicily and Salerno. In Normandy I had 23 been transferred to a liberty ship and we didn't 24 arrive at Omar Beach until O.D. plus twenty or Page 18 1 something. But oh, yes, the other two landings 2 we were on, one was measured in hours. I could 3 look that up -- no, I don't think I can. 4 Q. Then after the war you 5 returned to Beth Israel Hospital? 6 A. Yes. 7 Q. And did a residency, is that 8 correct? 9 A. Yes. 10 Q. What was your residency in, 11 Doctor? 12 A. Internal medicine. 13 Q. And did you complete that 14 residency? 15 A. Yes. 16 Q. When was that residency 17 completed? 18 A. Forty-seven, I guess -- wait a 19 minute, '48. 20 Q. Now was it during the period 21 of time that you were completing your residency 22 that you began instructing in pharmacology at New 23 York College of Medicine -- New York University 24 College of Medicine? Page 19 1 A. The first year of the 2 residency was a year to be devoted to basic 3 research and I was assigned to the pharmacology 4 department at the New York University where I had 5 worked even as a medical student. And then the 6 second year was as a supervisor of the other 7 residents, I was chief resident of medicine so 8 the clinical experience was the second year. The 9 first year was mostly in research but I did have 10 some rudimentary contact with patients during the 11 first year. 12 Q. Was that first year of study, 13 was that devoted to pharmacology or internal 14 medicine? 15 A. Yes, pharmacology. 16 Q. Then when did you begin your 17 private practice? 18 A. In July of 1949 -- '48. 19 Q. In Rochester? 20 A. No, New York City. 21 Q. But then shortly thereafter 22 moved to Rochester? 23 A. I had the opportunity to do 24 full-time research in pharmacology and I decided Page 20 1 that I enjoyed that more than clinical practice 2 so I went to the University of Rochester where I 3 was a member of the pharmacology department. 4 Q. And were you a professor of 5 pharmacology from 1949 to '51? 6 A. No, I was an instructor, then 7 assistant professor until I was invited to come 8 to Eli Lilly and Company. 9 Q. When was that? 10 A. 1954. 11 Q. Are you board certified, 12 Doctor Slater, in any particular specialty? 13 A. No. 14 Q. Have you applied for board 15 certification in any particular specialty? 16 A. I applied for board 17 certification in internal medicine but never 18 followed through on it. 19 Q. Did you take the exam? 20 A. I took the written exam and 21 passed, and having an oral examination -- having 22 been out of clinical practice for sometime, and I 23 did not pass. 24 Q. When was that, Doctor? Page 21 1 A. In 1956, I would guess. 2 Q. And that board certification 3 was going to be in internal medicine? 4 A. Yes, I started doing that as 5 an insurance should I decide to go back in 6 practice but I never did. 7 Q. When you were in private 8 practice did you ever hold yourself out as a 9 specialist in pharmacology? 10 A. No. 11 Q. The short period of time that 12 you were in private practice, what did your 13 practice consist of? 14 A. It was just mostly a few 15 patients each day who were referred to me by 16 various people. 17 Q. Would that have been an 18 internal medicine practice? 19 A. It was more a general 20 practice. 21 Q. Then when did you join Eli 22 Lilly and Company, you said 1954 but do you have 23 a date? 24 A. Yes, September. Page 22 1 Q. At the University of Virginia 2 at Charlottesville, did you take any courses or 3 did you have any specialized training in 4 psychology or any subject of that nature? 5 A. I took the elementary courses 6 in psychology. 7 Q. At New York University College 8 of Medicine, did you have any psychiatry courses? 9 A. Yes. 10 Q. How many, basic? 11 A. Just the basic standard 12 courses that was given at the time. 13 Q. And would that have been a one 14 year course, one semester course? 15 A. I really don't remember. 16 Q. After the basic course in 17 psychiatry that you had at New York University 18 College of Medicine, did you have any other 19 formal training in psychiatry or psychology? 20 A. No. 21 Q. When did you first develop an 22 interest in pharmacology? 23 A. In my second year of medical 24 school. Page 23 1 Q. In medical school, did you 2 have any courses on neuropsychopharmacology? 3 A. No, I don't think. 4 Q. Was there even such a thing 5 then? 6 A. That's what I was going to 7 say, no. 8 Q. Have you ever had any courses 9 in neuropsychopharmacology? 10 A. I have mostly given them 11 rather than taken them. 12 Q. When did you first become 13 conversant in neuropsychopharmacology? 14 A. When I went to Rochester. 15 Q. What type of experience did 16 you have at the University of Rochester in 17 connection with neuropsychopharmacology? 18 A. Well it was -- my initial 19 research was in centrally acting muscle relaxants 20 and then after the second year, my 21 responsibilities continued in that general field 22 but we did research in other sections of 23 pharmacology that were more basic in nature. 24 Q. Did you do any work on central Page 24 1 nervous system pharmacology? 2 A. We studied anticonvulsant 3 drugs. 4 Q. Was that about the extent of 5 neuropsychopharmacological drugs was antiseizure 6 drugs? 7 A. And muscle relaxants. 8 Q. Do muscle relaxants work on 9 the nervous system or on the muscle system? 10 A. The nervous system. 11 Q. At or during your studies at 12 the University of Rochester, was there anything 13 known at that time or was there any development 14 of thought concerning whether or not brain 15 chemistry could affect individuals' mood or 16 behavior? 17 A. Please repeat the question. 18 Q. By the time you completed your 19 work at the University of Rochester, was the 20 scientific knowledge such at that time that there 21 was any belief or any documentation that brain 22 chemistry could affect mood? 23 A. I think at that point, the 24 field was emerging. Page 25 1 Q. In what respect? 2 A. Doctor Brodie had published 3 papers on the role of serotonin as a possible 4 neurotransmitter. This is Bernard Brodie at the 5 National Institute of Health. 6 Q. How does he spell his name, 7 B-R-O-H? 8 A. B-R-O-D-I-E. 9 Q. And do you remember what that 10 first publication was in connection with 11 serotonin and behavior or serotonin as being a 12 neurotransmitter? 13 A. I had an abstract on that 14 subject myself in 1954, trying to explore whether 15 serotonin affected transmission in the spinal 16 cord. The results are a little bit shaky, I 17 think, they were very preliminary. 18 Q. My question was what was the 19 name of the article by Doctor Brodie? 20 A. I don't know, I remember 21 discussing it with him. 22 Q. Was he at the University of 23 Rochester? 24 A. No. I had known him from New Page 26 1 York University but he was the leader of the 2 extensor group of pharmacologists at N.I.H. 3 Doctor Brodie is one of the giants in American 4 pharmacology. 5 Q. Is he still alive? 6 A. I don't know, he's older than 7 I am so -- and he retired in not very good health 8 but I have not read a death notice. 9 Q. Doctor Slater, why don't we 10 take this time, we're kind of at a crossroads 11 point, I forgot to explain to you who I am and 12 what we're doing today. My name is Paul Smith, I 13 live in Dallas, Texas, I'm an attorney and I 14 represent several individuals and families of 15 individuals who have attempted suicide or 16 committed suicide while being treated with 17 Fluoxetine Hydrochloride which is known as 18 Prozac. We are here today to take your 19 deposition in connection with lawsuits we filed 20 on those individuals' behalf. Do you understand 21 that? 22 A. Yes. 23 Q. As I understand it, you were 24 first contacted by Ms. Nancy Zettler from a Page 27 1 lawyer's office in -- a lawyer in Chicago? 2 A. Actually it was Rene Mortimer. 3 Q. Rene, Ms. Mortimer here first 4 contacted you? 5 A. Yes. 6 Q. Did Ms. Mortimer explain to 7 you that she was an attorney in Chicago who also 8 represented individuals who were claiming -- 9 making claims against Lilly as a result of 10 treatment with Prozac? 11 A. Yes. 12 Q. And I believe we arranged or 13 she arranged for your deposition here today. 14 A. Yes. 15 Q. Do you understand that a 16 deposition is sworn testimony that you give 17 before a court reporter that can be used as 18 evidence in the trial in these cases? 19 A. Yes. 20 Q. And that you are sworn in 21 today and that your testimony has the same force 22 and effect as if you were in a courtroom 23 testifying live in front of a jury? 24 A. Yes. Page 28 1 Q. For those reasons, Doctor 2 Slater, it's important that you and I 3 communicate, all right? If I ask you any 4 questions that you don't understand, would you 5 please let me know? 6 A. Yes. 7 Q. I think you asked me to repeat 8 one question or rephrase one question. Be sure 9 and continue to do that so that we will know that 10 we're on the same track, okay? 11 A. Okay. 12 Q. Additionally, you need to give 13 an audible answer so our court reporter can get 14 that down on her magic machine there. All right, 15 would you do that? 16 A. I understand. 17 Q. You were employed with Eli 18 Lilly and Company from 1954 until December 31st, 19 1979, correct? 20 A. Yes. 21 Q. After you were contacted by 22 Ms. Mortimer, did you make contact with anybody 23 at Eli Lilly in connection with Ms. Mortimer's 24 request that you give your deposition? Page 29 1 A. I called Mary Huff. 2 Q. How did you know to call Ms. 3 Huff? 4 A. Ms. Huff had called me some 5 years previously to say that I might be contacted 6 and should I be contacted would I let her know. 7 Q. Can you give us any idea when 8 it was Ms. Huff first contacted you? 9 A. Only in general terms, two or 10 three years. 11 Q. You had retired and you were 12 living here in Naples, Florida, when you were 13 contacted by Ms. Huff? 14 A. Yes. 15 Q. Did you know Ms. Huff when you 16 were at Lilly? 17 A. No. 18 Q. After you called Ms. Huff and 19 advised her that you had been called by Ms. 20 Mortimer, did she suggest to you that you should 21 secure counsel in connection with this? 22 A. I don't think so. Sometime 23 earlier, Mister Lore had come to visit me to find 24 out in general terms what I remembered off the Page 30 1 top of my head. That was what about six months 2 ago, Steve? 3 MR. LORE: Probably. 4 Q. So that would have been in the 5 year 1993 that Mister Lore came to visit you? 6 A. Yes. 7 Q. Then you are here being 8 represented by Mister Armstrong, is that correct? 9 A. Yes. 10 Q. How did you get Mister 11 Armstrong's name? 12 A. Mister Lore suggested that 13 since I was appearing, I should have somebody to 14 represent me and he selected someone from Florida 15 who is knowledgable. 16 Q. Mister Lore selected someone? 17 A. Suggested. 18 Q. Suggested someone, suggested 19 Mister Armstrong to represent you? 20 A. Yes. 21 Q. And is it your understanding 22 that Eli Lilly and Company or Mister Lore has 23 made arrangements for Mister Armstrong's 24 attorney's fees in connection with this matter? Page 31 1 A. Yes. 2 Q. And you are not going to 3 actually have to pay attorney's fees to Mister 4 Armstrong as a result of your representation here 5 today and tomorrow? 6 A. Yes. 7 Q. And is that going to be taken 8 care of by Eli Lilly and Company? 9 A. That's my understanding. 10 Q. Have you talked to Doctor Paul 11 Stark in the last year and a half? 12 A. Yes. 13 Q. Have you talked to Doctor Paul 14 Stark since he's given his deposition in 15 connection with these cases? 16 A. It was just a year ago that I 17 talked with Paul and he came to have lunch with 18 me. I don't know when he gave his deposition but 19 I have not talked with him this year. 20 Q. Did you and he discuss that he 21 had given a deposition? 22 A. No. 23 Q. He didn't tell you he had met 24 me here? Page 32 1 A. This was a year ago that I 2 talked to him. 3 Q. I'm disappointed. 4 A. I don't know when you -- I 5 really don't know when he -- 6 Q. I think we were here on more 7 than one occasion. I think we were last here in 8 March of last year. Would you have had lunch 9 with him since then? 10 A. He and I usually have lunch in 11 March or February, and he and his wife, I think, 12 came to visit me last year. Now, I'm not going 13 to swear that this is true, this is the best of 14 my recollection. I think I have seen them twice 15 since Doctor Stark has his knew wife and -- but 16 it may be that last year we were unable to get 17 together because he travels a great deal more 18 than I, but we have not discussed the deposition. 19 Q. Have you discussed the issues 20 that have been raised by the depositions in these 21 lawsuits, that is the role of Prozac, Fluoxetine 22 Hydrochloride and suicidality and violence? 23 A. I really don't remember 24 discussing it, we may have in passing but Page 33 1 certainly not in any great detail. 2 Q. Doctor Stark is here only part 3 of the year, is that correct, Doctor Stark comes 4 and lives in the Fort Myers area only part of the 5 year? 6 A. Yes. 7 Q. You live here full-time? 8 A. Yes. 9 Q. Summers and winters? 10 A. Yes. 11 Q. Now, when you began with -- do 12 you need to take a break? 13 A. No, just curious what time it 14 was. 15 Q. We can take a break at any 16 time. 17 MS. MORTIMER: It's quarter of ten. 18 THE WITNESS: I know, I have a watch. 19 Q. Anytime you need to know what 20 time it is, let us know and Ms. Mortimer will 21 tell you. 22 MS. MORTIMER: That's my job, if 23 anybody wants to know what time it is, ask me. 24 Q. What was your first job in Page 34 1 connection with your employment at Eli Lilly and 2 Company? 3 A. I was a senior pharmacologist. 4 Q. Were you working for Lilly 5 Research Labs or Eli Lilly and Company? 6 A. It's the same thing. The 7 component that I was in was Lilly Research 8 Laboratories, and I was in the division of 9 pharmacology. 10 Q. Was your work there research 11 work or what exactly were you doing as a senior 12 pharmacologist when you began at Lilly? 13 A. I was assigned to do research 14 in the central nervous system. 15 Q. And specifically what were you 16 researching in connection with the central 17 nervous system? 18 A. Well, the first paper I wrote 19 was on a research analog called Recanecine, or 20 something like that, in general to find drugs 21 that would be useful in treating mental illness 22 of various types. 23 MR. SMITH: Let's take a break. 24 (A SHORT BREAK WAS TAKEN.) Page 35 1 Q. (BY MR. SMITH) Were you doing 2 research to investigate various compounds that 3 were being investigated by Lilly as potential CNS 4 active drugs? 5 A. Yes. 6 Q. Can you give me the names of 7 any compound that later became marketed by Lilly? 8 I'm not interested in potential drugs that were 9 tested and never got on the market, but what were 10 some of the first drugs that you researched that 11 were eventually marketed by Lilly? 12 A. Phenygycol, I think, that's 13 called Ultren. 14 Q. When was it first marketed by 15 Lilly? 16 A. Probably 1955 or '56. 17 Q. What was that drug used for? 18 A. It was a neuro sedative. 19 Q. For sleep, to reduce 20 agitation? 21 A. To reduce anxiety. 22 Q. Is Ultren still on the market? 23 A. No. 24 Q. When was -- when did Lilly Page 36 1 cease marketing Ultren? 2 A. About 1960, I guess. 3 Q. Why did they discontinue that 4 product? 5 A. It must have been later than 6 that, more likely about 1969 or '64. The 7 original clinical trials demonstrated that when 8 carefully compared with other neurosedatives that 9 Lilly -- that Ultren was at least as good as or 10 better than these compounds. These were based on 11 a limited number of patients. The FDA wanted a 12 much much larger study and the company didn't 13 think that they could afford the size trial that 14 the FDA wanted, so rather than undertake the 15 trial, they agreed to withdraw the compound from 16 the market. 17 Q. But was it actually marketed? 18 A. It was on the market and also 19 it was marketed in a combination with Darvon 20 called Darvitran. 21 Q. Darvon was a Lilly medication 22 that had already been -- was already on the 23 market, is that correct? 24 A. Yes, but -- yes. Page 37 1 Q. But the Ultren was a separate 2 and independent medication? 3 A. Yes. 4 Q. That was given -- it was an 5 antianxiety agent? 6 A. Uh-huh. 7 Q. Whereas Darvon is primarily a 8 pain medication, is it not? 9 A. Yes. 10 Q. In '63 or '64, the FDA 11 requested a larger clinical trial? 12 A. Uh-huh. 13 Q. Involving more subjects than 14 had been previously tested? 15 A. Yes. 16 Q. Was there a particular problem 17 with the drug that it caused the FDA to ask? 18 A. No. 19 Q. Do you have any idea why they 20 were asking for a larger clinical trial? 21 A. This was after the Kefauver 22 investigation of the Thalidomide disaster and 23 other things, and the whole basis for putting 24 drugs on the market was to be reinvestigated by Page 38 1 the FDA and this was more or less a routine 2 request. 3 Q. And I assume that someone at 4 Lilly made the corporate decision that Ultren 5 sales were not such that would justify the 6 expenditures that would be involved in further 7 clinical trials? 8 A. That's possible, but I'm not 9 sure that I could say that with assurance. 10 Q. Would there be any other 11 reason that Lilly would not undertake -- 12 A. No, not really. 13 Q. Was your work exclusively on 14 Ultren? 15 A. No. 16 Q. What other while you -- how 17 long were you a senior pharmacologist, by the 18 way? 19 A. About a year. 20 Q. So that would be 1954 to 1955? 21 A. Yes. 22 Q. Did you work on any other 23 compound that was marketed as a central nervous 24 system agent? Page 39 1 A. I worked on Mephihexital, 2 which is Brovital, which is a short acting 3 anesthetic. 4 Q. Is it still on the market? 5 A. Yes. 6 Q. Which is primarily used as a 7 short term acting anesthetic? 8 A. Induction of anesthesia. 9 Q. Any other CNS medications that 10 you worked on while you were a senior 11 pharmacologist? 12 A. Well, the time frame is a 13 little bit loose. In 1955, I became head of the 14 department of neuropharmacology. It was just a 15 change in title and gave me a responsibility for 16 supervising the work of other people but my own 17 laboratory work continued and I can't say with a 18 great deal of detail what I did between the 19 change in responsibility. 20 Q. How long were you the head of 21 the department of neuropsychopharmacology? 22 A. Until I became director, let's 23 see, until there was a big reorganization and I 24 think I became a research advisor. I'm not Page 40 1 exactly sure, but I think that happened about 2 1958 or '59. Then there was another 3 reorganization a couple of years later and I 4 became director of pharmacological research. 5 Q. When did you become director 6 of pharmacological research at Lilly, 7 approximately? 8 A. Maybe 1965, maybe a little 9 earlier. 10 Q. And how long were you the 11 director of pharmacological research? 12 A. Until about 1972. 13 Q. And what job function did you 14 take over in 1972? 15 A. After that, I became a 16 research advisor again, and my formal 17 responsibility no longer included supervision of 18 the CNS area but included the cardiovascular 19 area. 20 Q. Up until from 1955 until 1972, 21 you were in CNS, central nervous system 22 medications? 23 A. Yes. 24 Q. But then in 1972, you took on Page 41 1 the additional area of cardiovascular 2 medications? 3 A. No, that's not correct. 4 Q. Okay. 5 A. In 1972, I no longer had 6 administrative responsibility for the people 7 doing central nervous system research, but my own 8 research continued to be in central nervous 9 system drugs and I had formal responsibility for 10 the administration of people who were doing 11 cardiovascular research. 12 Q. And how long were you a 13 research advisor? 14 A. Until I retired. 15 MR. SMITH: Let's take a break 16 (A SHORT RECESS WAS TAKEN.) 17 Q. (BY MR. SMITH) Doctor Slater, 18 in connection with your work on all these CNS 19 active drugs, and when I say CNS active drugs can 20 we understand that I'm talking central nervous 21 system active drugs? 22 A. Yes. 23 Q. And that would be drugs that 24 act on the brain and nerves, is that right? Page 42 1 A. Brain and spinal cord. 2 Q. When did you first participate 3 in any clinical trials in connection with CNS 4 active drugs? 5 A. When I was in Rochester trying 6 to develop muscle relaxant drugs to see if such 7 drugs would help in the managing of poliomyelitis 8 and also whether such drugs would help children 9 with cerebral palsy. This was in 1951 and '52. 10 Q. And were you participating in 11 clinical trials on human subjects? 12 A. Yes. 13 Q. And was this investigating a 14 particular drug? 15 A. We looked at a compound which 16 was in the polio patients which was called 17 Prenderol. Fortunately we didn't get to treat 18 many patients, the one patient I remember 19 individually that we were supposed to treat, we 20 didn't get to give him the medication and about 21 six hours later, he developed a complete 22 paralysis. If we had given him the medication we 23 would have really been on the hook, it was one of 24 the luckier experiences in my life. Page 43 1 Q. Was Prenderol a medication 2 that was eventually marketed? 3 A. I think so, by E. R. Squibb 4 and Sons, I think it had a very short life. 5 Q. But this was a clinical trial 6 as we know it today where human subjects were 7 given a particular medication? 8 A. It was a clinical trial but 9 not as we know it today. 10 Q. What would be the primary 11 difference in that clinical trial than in 12 connection with Prenderol and one that we know 13 today? 14 A. Well, today a clinical trial 15 would start with extensive trials in normal 16 subjects with blood levels and so on and so forth 17 before attempting to treat any patients with the 18 disease. 19 Q. But back then, you would go 20 ahead and administer a medication to a patient 21 with the disease and not necessarily have a 22 background of information where that medication 23 had been given to healthy human subjects? 24 A. I think so. Page 44 1 Q. What would have been the next 2 clinical trial that you participated in? 3 A. I tried a few patients at a 4 cerebral palsy clinic with Chlorpromacine. 5 Q. Would you spell that for us? 6 A. Thorazine, 7 C-H-L-O-R-P-R-O-M-A-C-I-N-E, which is Thorazine, 8 T-H-O-R-A-Z-I-N-E. 9 Q. When was that? 10 A. That would be 1954, I think. 11 Q. Was that before you went to 12 Lilly? 13 A. Yes. 14 Q. And you were treating patients 15 with cerebral palsy with Thorazine? 16 A. Yes. 17 Q. As part of a clinical trial? 18 A. Well, the compound was already 19 on the market at that time or about to go on the 20 market and it was said to be a remarkable 21 tranquilizer agent and I wondered whether it 22 would help the children who had athetosis, which 23 is a lot of spontaneous movements that seemed to 24 interfere with their ability to do anything. Page 45 1 Q. Did you receive a grant? 2 A. No. 3 Q. Any type of direction from any 4 pharmaceutical firm in connection with that work? 5 A. No, they -- I requested the 6 material, they sent me information about it and I 7 tried it in one or two patients. 8 Q. Any other clinical trials that 9 you participated in before you joined Eli Lilly 10 and Company? 11 A. Not to my recollection. 12 Q. What was the first clinical 13 trial that you participated in at Eli Lilly and 14 Company? 15 A. Fluoxetine. 16 Q. When did you first engage in 17 clinical trials in connection with Fluoxetine or 18 Prozac? 19 A. 1978. 20 Q. So until you began your work 21 with Prozac, Fluoxetine Hydrochloride in 1978, 22 you had not participated in any clinical trials 23 on any human subjects or been involved in 24 clinical trial work since 1954 when you were Page 46 1 giving Thorazine to cerebral palsy patients? 2 A. The situation was entirely 3 different. In the one case I was responsible for 4 the patient, in the other case I was merely 5 administering the research of people who were 6 primarily experts in the field. 7 Q. Up until Fluoxetine, you had 8 never been a medical monitor or been an 9 individual who had been in charge of 10 administering a clinical trial in connection with 11 any compound? 12 A. That's true. I had, what 13 shall I say, reviewed data with people who had 14 tested the various central nervous system drugs 15 that we had developed and had gone over the data 16 with them so I knew how clinical trials were 17 supervised but I had never had personal 18 responsibility for communicating directly with 19 the expert investigators who were actually 20 testing the drug. 21 Q. When you say expert 22 investigators, you're talking about investigators 23 out in the field? 24 A. Yes. Page 47 1 Q. At various sites doing the 2 actual clinical trials? 3 A. Yes. 4 Q. And you had never done that up 5 until you started working with Fluoxetine 6 Hydrochloride? 7 A. Well, I wouldn't say never 8 because I did visit with Doctor Bennet in, oh, I 9 can't remember exactly when. We had paid a visit 10 to Doctor Nathan Kline at the -- well, it's in 11 New York, it's Orange something, I forgot, it was 12 a large New York state facility where he had done 13 some research on one of the compounds we had 14 developed. 15 Q. As part of a clinical trial? 16 A. As part of a clinical trial. 17 So I had in that case direct contact with the 18 investigator himself, but that was the only 19 direct contact. However I should say that Eli 20 Lilly maintains a clinical research facility and 21 all the compounds that Lilly is going to submit 22 to outside investigators are investigated 23 initially at the Lilly clinic and obviously I had 24 direct contact with these people. Page 48 1 Q. I understand that, but my 2 questions right now deal with the first time you 3 had ever been responsible for the administration 4 of clinical trials was in 1978 with Fluoxetine 5 Hydrochloride, is that correct? 6 A. That's correct. 7 Q. Prior to that, your work had 8 been limited to pharmacology on site at Lilly? 9 A. Yes. 10 Q. Now had you done any work in 11 connection with Fluoxetine Hydrochloride, Prozac, 12 before you began doing the clinical trial 13 administration in 1978? 14 A. Yes. 15 Q. Tell us what your first work 16 was in connection with Fluoxetine Hydrochloride. 17 A. My own personal work involved 18 two experiments -- three experiments. The first 19 experiment was done in anesthetized cats to 20 determine whether the compounds had any effects 21 on the cardiovascular system. 22 Q. Let me stop you just a second. 23 When was that experiment done? 24 A. Probably 1972, I would say, Page 49 1 '73. 2 Q. How long did that experiment 3 last? 4 A. A matter of weeks. 5 Q. How many cats do you recall 6 were used in that study or experiment? 7 A. Probably a dozen or so. 8 Q. Tell me how you -- 9 A. This is just off the top of my 10 head, it could be more or less. 11 Q. I understand. I would assume 12 when you're giving the specific information in 13 connection with something done twenty years ago, 14 you don't remember the number of cats you put to 15 sleep? 16 A. That's possible. 17 Q. Tell me about, we'll call it 18 the cat experiment. 19 A. I don't remember anything 20 except that they didn't show anything that 21 concerned us. 22 Q. The purpose of that 23 experiment, would it be correct, Doctor Slater, 24 to say that the purpose of that experiment was to Page 50 1 examine whether or not Fluoxetine Hydrochloride 2 had any affect on the heart of cats? 3 A. Yes. 4 Q. And your recollection is that 5 your experiment with twelve cats didn't 6 demonstrate any effect that Fluoxetine 7 Hydrochloride had on those cat hearts? 8 A. Right. 9 Q. What was the next experiment? 10 A. We had a colony of cats with 11 electrodes implanted in various sites in the 12 brain and we were studying the effects of drugs 13 on sleep patterns in cats. 14 Q. Let's call that first 15 experiment with the cats and cardiovascular 16 research the heart experiment. 17 A. Yes. 18 Q. Let's call this one the -- 19 A. Sleep experiment. 20 Q. Sleep experiment. 21 A. Uh-huh. 22 Q. How many cats were used in 23 that study? 24 A. I guess our colony consisted Page 51 1 of a dozen or so cats and probably all of them 2 received the compound several times. 3 Q. How long did it last? 4 A. Probably several months. 5 There's a paper there that we could check the 6 exact number of cats, if you're interested. 7 Q. Only mildly. What were the 8 results of that experiment? 9 A. The result of the experiment 10 showed that Fluoxetine was remarkable in causing 11 a suppression of REM sleep. 12 Q. Remarkable in causing a 13 suppression of REM sleep. Now let's put that in 14 lay person's terms, Doctor Slater. Does that 15 mean that those cats slept better or worse? 16 A. Different. 17 Q. Different. How different? 18 A. They had no REM sleep. 19 Q. What is REM sleep? 20 A. REM sleep is a sleep 21 associated with fast activity, fast activity in 22 the brain waves from surface electrodes and 23 spiking from the genicular body. 24 Q. I thought we were going to Page 52 1 talk about lay person stuff. REM means rapid eye 2 movement, does it not? 3 A. Yes. 4 Q. And is the quality of sleep 5 involving REM sleep different than other types of 6 sleep? 7 A. REM sleep is the sleep that 8 occurs usually with dreaming and it occurs in 9 humans at intervals about an hour and a half and 10 cats in about intervals of thirty minutes and 11 then goes on for a period of time and then 12 reverts back to slow wave sleep. 13 Q. What is the significance that 14 Fluoxetine caused a remarkable increase in 15 suppression of REM sleep? 16 A. I think in my mind it was the 17 fact that Doctor Vogel at the University of 18 Chicago had postulated that it was characteristic 19 of antidepressant drugs to suppress REM sleep. 20 Q. From that, were you 21 postulating that Fluoxetine Hydrochloride had 22 antidepressant properties because if also 23 suppressed REM sleep? 24 A. That was the inference. Page 53 1 Q. So in that experiment, you 2 demonstrated that Fluoxetine Hydrochloride 3 actually caused a difference in the quality of 4 sleep of cats? 5 A. Yes, sir. 6 Q. You demonstrated that the 7 ingestion of Fluoxetine Hydrochloride in those 8 cats resulted in a physical change in physiology 9 or the body functions of those cats, is that 10 correct? 11 A. Yes. 12 Q. And that that change was 13 similar to changes produced by other drugs that 14 had antidepressant qualities, is that right? 15 A. Yes. 16 Q. Are there other drugs other 17 than antidepressants that create suppression in 18 REM sleep, in either humans or animals? 19 A. I think I'm not sure that I 20 remember the literature as well as I used to know 21 it. I don't want to make a statement which is 22 incorrect. 23 Q. Any other findings in 24 connection with the sleep pattern study done on Page 54 1 the colony of cats? 2 A. The cats seemed to have 3 dilated bladders, they didn't seem to urinate as 4 well. 5 Q. Any other changes? 6 A. That's all that I remember. 7 Q. Did you say you had a copy of 8 a paper you had written in connection with that 9 experiment, Doctor Stater? 10 A. Yes. 11 Q. Was that the paper that you 12 wrote along with G. D. Jones and R. A. Moore? 13 A. Yes. 14 Q. That was published in 15 neuropharmacology, Volume 17? 16 A. I think so, yes. You are 17 reading it. 18 Q. In approximately 1978? 19 MR. ARMSTRONG: He might be more 20 comfortable if you let him see it. 21 MR. SMITH: I'm going to. I wanted to 22 identify it before I handed it to him. 23 Q. This is your only copy? 24 A. This is my only copy. Page 55 1 Q. Why don't you look at it and 2 see if you can identify that document that you 3 earlier handed us as being the paper that 4 reflects your study on sleep behavior in cats? 5 A. Yes. There's nothing here 6 that shows what the year was that it was 7 published but it would probably be a period in 8 '78. 9 Q. Looking right here where it 10 says copyright Pergamon Press 1978? 11 A. I see, okay. 12 MR. SMITH: Can we make copies of all 13 these documents at a break or at lunch or 14 something? 15 MR. LORE: Fine. 16 MR. SMITH: But I want to mark this 17 cat study, the cat sleep study as Exhibit 1, 18 okay? 19 (PLAINTIFFS' EXHIBIT NO. 1 WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Is REM sleep something that's 23 considered necessary in humans or desirable in 24 humans? Page 56 1 A. In the original paper by 2 Doctor Dement, he proposed that depravation of 3 REM sleep might have dilatorious effects but he 4 later retracted that view and I don't think that 5 it's the current view that it is essential, and 6 as I said, Doctor Vogel postulated that the 7 absence of REM sleep seemed to have therapeutic -- 8 seemed to be associated with the therapeutic 9 affects of -- there's a reference to Doctor 10 Vogel's paper either in this paper or one of the 11 others. 12 Q. In any event, this experiment 13 demonstrated specifically that Fluoxetine 14 Hydrochloride, Prozac, caused physiological 15 changes in these cats? 16 A. Yes. 17 Q. It caused their brain to act 18 differently than it had done prior to their being 19 given this Prozac, this Fluoxetine Hydrochloride? 20 A. Yes. One wouldn't expect a 21 drug to have therapeutic effects on the brain 22 unless it had some affect there. 23 Q. Well, we know from reviewing 24 the clinical trial data and the summaries of FDA Page 57 1 approval and everything, that Fluoxetine 2 Hydrochloride was found by the Food and Drug 3 Administration to be no more efficacious, 4 efficacious than any other antidepressant 5 currently marketed and that's the reason for my 6 questions is that it does, even though it's no 7 more efficacious than any other antidepressant, 8 Fluoxetine Hydrochloride in your findings 9 certainly did indicate some specific changes in 10 brain chemistry in animals in this study, is that 11 correct? 12 A. Studies indicated that all the 13 other antidepressants had the same effects. 14 Q. Yes. How long did that study 15 last? You said several months. 16 A. I'm sorry? 17 Q. What other experiment did you 18 do in connection with Fluoxetine Hydrochloride? 19 A. We did a very preliminary 20 experiment in baby chicks to see whether 21 Fluoxetine would enhance the sleep promoting 22 properties of five hydroxytryptamine. Baby 23 chicks don't have a blood brain barrier and 24 administration of serotonin to chicks causes them Page 58 1 to sleep a little bit and we did some preliminary 2 experiments which seemed to show that in baby 3 chicks Fluoxetine enhanced the sleep producing 4 properties. These were not of such strength or 5 to justify publication, although I did include 6 the data in my report to the FDA for purposes of 7 complete disclosure. 8 Q. When was the experiment done? 9 A. Seventy-six. 10 Q. So it was done after the cat 11 heart experiment but before the cat sleep pattern 12 experiment? 13 A. No, the cat sleep patterns 14 were done very early, probably in '73 or '74, 15 they were just published at that later date. 16 Q. Any other experiments that you 17 did in connection with Fluoxetine Hydrochloride 18 before you became involved in the actual clinical 19 trials? 20 A. Not that I can recall. 21 Q. Were there other experiments 22 that were done during that time by other 23 researchers there at Lilly? 24 A. Yes. Page 59 1 Q. Few or many? 2 A. Many. 3 Q. Can you give me the names of 4 the individuals who were principally involved in 5 that research? 6 A. Doctor Fuller and Doctor Wong. 7 Q. Did you do any rat studies or 8 mice studies in connection with experimental work 9 prior to your beginning the clinical trial phase? 10 A. In my diary, there was a note 11 that I asked somebody to do rat studies to check 12 on kidney and bladder function because I was 13 curious about the cats and I don't know whether -- 14 I think they were done by other people and I 15 don't remember who it was. Those experiments 16 were negative so we felt comfortable in going 17 ahead. 18 Q. I see G. T. Jones and 19 R. A. Moore listed as co-authors of this cat 20 sleep paper with you, who were they? 21 A. My technical assistants. 22 Q. What would have been your 23 formal title when you were doing these 24 experiments? Page 60 1 A. I didn't hear you. 2 Q. What would have been your 3 title, your job description title 4 when you were doing these experiments with 5 Fluoxetine Hydrochloride? 6 A. I was either director of 7 pharmacological research or research advisor. 8 Q. Had you done any other work on 9 Fluoxetine Hydrochloride in any fashion before 10 you became clinical trial administrator and the 11 medical monitor on Fluoxetine Hydrochloride in 12 1978 other than the experiment that you 13 described? 14 A. I guess it depends on how you 15 define work. Experimental work, only the things 16 that you said, but if you include on the work 17 attending meetings and discussions, then I did 18 lots of other work because I reviewed data with 19 Doctor Wong and Doctor Fuller many times so I had 20 a fairly broad knowledge of what had been done. 21 Q. Why were you reviewing data 22 with Doctor Wong and Doctor Fuller? 23 A. Because this was the most 24 interesting thing that happened to me in years. Page 61 1 Q. Were you a director of 2 pharmacological research at the time and Wong and 3 Fuller were working under you or were you working 4 under them? Tell me how specifically you and 5 Doctor Wong and Doctor Fuller were brought 6 together in the Lilly scheme of things. 7 A. I had hired Doctor Fuller some 8 half a dozen years before to join our CNS group 9 and I had brought Doctor Wong into the CNS group 10 and these were my, what shall I say, my boys. 11 Well when the pharmaceutical manufacturer's 12 association awarded the Discovers Prize to Doctor 13 Fuller, Doctor Wong and Doctor Molloy, Doctor 14 Fuller was asked who had the most influence on 15 him in his life and also Doctor Molloy and they 16 both mentioned me. 17 Q. That's quite a compliment. 18 A. Well people -- Doctor Herr who 19 was the director of -- was the executive 20 vice-president in charge of many components in 21 the company said Doctor Slater was sorely lacking 22 in administrative ability but he certainly was a 23 great recruiter. 24 Q. That's kind of a double edged Page 62 1 compliment, wasn't it? 2 A. Well, yes. 3 Q. But you recruited Fuller? 4 A. Yes. 5 Q. Wong and Molloy? 6 A. No, no. Molloy came to Lilly 7 because of his interest in chemistry. I helped 8 divert him from his interest in basic chemistry 9 and into becoming interested in medicinal 10 chemistry. This is a wholly unrelated study 11 which I could describe to you but I don't think 12 it would further your case and you might not 13 understand it anyhow. 14 Q. Probably certainly wouldn't 15 understand it. Was it with your encouragement 16 that Doctor Fuller and Doctor Wong and Doctor 17 Molloy developed and synthesized Fluoxetine 18 Hydrochloride? 19 A. No, not entirely. Doctor 20 Molloy had been enacting with the various people 21 in pharmacology and doing a great deal of reading 22 and felt there was a possibility of developing an 23 important antidepressant drug. He and Doctor 24 Rathbun set up a screen to find such a drug and I Page 63 1 suggested to Doctor Wong that he should do 2 biochemical studies on the compound that were 3 coming out of the screen that Doctor Molloy were 4 submitting to Doctor Rathbun. 5 Q. Who was Doctor Rathbun? 6 A. Doctor Rathbun was a 7 pharmacologist in charge of examining the 8 preliminary effects of drugs in mice. 9 Q. When was that that you made 10 the suggestion that these individuals coordinate 11 their work? 12 A. I reviewed my diaries to find 13 out when that was and I'm not exactly sure. It 14 was very early in the study itself, it's not in 15 the diaries. 16 Q. Is this diary in chronological 17 order? 18 A. Yes, I think so. 19 Q. The first entry that I see is 20 in November of 1970. 21 A. Yes. 22 Q. Would that suggestion that you 23 made in connection with their getting together on 24 this project have been before or after November Page 64 1 of 1970? 2 A. The suggestion is -- no, my 3 suggestions to Doctor Wong came after that, 4 probably' 71 or '70, probably in '71. 5 Q. They were doing the work 6 though, is that correct? 7 A. Who do you mean by they? 8 Q. Wong, Fuller and Molloy, they 9 were the ones who were actually involved in this 10 discovery. 11 A. Yes. 12 Q. You were the director of the 13 group that they were in, is that right? 14 A. I wasn't the director in the 15 sense that I told them what to do, I was the 16 senior member, the oldest man around, and one who 17 had been around longest and had perhaps the 18 broadest experience but I was not directing what 19 they do. This is one of the reasons why I was 20 considered such a poor administrator because I 21 didn't try to tell people what to do, I felt that 22 the creativity came from science and not from 23 marketing people. My motto was marketing can 24 tell you with a great deal of accuracy what Page 65 1 researchers should have been doing ten years ago. 2 Q. I take it your area was in 3 research and not marketing? 4 A. Yes. 5 Q. You were never involved in the 6 marketing of any products of Eli Lilly and 7 Company? 8 A. No. 9 Q. Is that right? 10 A. True. 11 Q. We digressed but this is 12 interesting to me. Did you answer any specific 13 questions that Doctor Fuller, Molloy or Wong 14 might have had in connection with scientific 15 issues presented by Fluoxetine Hydrochloride? 16 A. Would you read that back, 17 please? 18 (THE COURT REPORTER READ BACK THE 19 REQUESTED TESTIMONY.) 20 A. Okay, the specific question of 21 does this compound have any adverse 22 cardiovascular effects, we addressed directly 23 with the cat experiments. Doctor Molloy was 24 curious and suggested we should do the chick Page 66 1 experiments since we were doing them in another 2 regard. But I think, I'm not sure, but I think 3 the idea of checking the sleep patterns of cats 4 was my own contribution intellectually. 5 Q. Even though you may have been 6 senior to these individuals, you were looking to 7 them as being the experts in connection with the 8 actual scientific properties of Fluoxetine 9 Hydrochloride, is that correct? 10 A. No. I hoped to think of 11 myself as a coequal in the section that they were 12 biochemist and chemist and my training was in 13 more physiological aspect of pharmacology, so the 14 kind of things that I was looking at represented 15 what happened to whole animals and what they were 16 looking at was what happened in the chemistry of 17 the brain, chemistry of particles and so on. 18 Q. You were looking at it from 19 maybe the broader physiological picture, is that 20 correct? 21 A. I don't think it's broader, 22 the things that you could see in animals rather 23 than results of chemical tests. 24 Q. Did you call any psychiatrist Page 67 1 or neuropsychopharmacologist in any discussions 2 in connection with Fluoxetine during this period 3 of time? 4 A. I don't think so. 5 Q. Did you call any experts in 6 who were familiar with and actually studied the 7 mental illness of depression? 8 A. At this time? 9 Q. Yes. 10 A. No. 11 Q. Did you call in any experts or 12 any individuals who were specifically 13 knowledgable concerning issues presented by 14 suicide and suicidality during this period of 15 time? 16 A. No. 17 Q. Did you consult with any 18 individuals who were expert or knowledgable in 19 connection with violent/aggressive behavior at 20 this time? 21 A. No. 22 Q. Would these experiments that 23 you did be part of what is called Phase 1 studies 24 or would they be Phase 2 studies? Page 68 1 A. What I did -- the clinical 2 studies that I supervised were Phase 2. 3 Q. I'm talking about the 4 experiments on cats. 5 A. They're clinical, they don't 6 come under the category of phases. 7 Q. They're not any phases? 8 A. Yes, they're preclinical 9 studies. 10 Q. Any other preclinical studies 11 that you were involved in, Doctor Slater? 12 A. That's my whole life, my 13 goodness. 14 Q. In connection with Prozac, 15 Fluoxetine Hydrochloride, I'm sorry, right now 16 we're going to be dealing with Prozac and 17 Fluoxetine Hydrochloride. 18 A. I don't think so. 19 Q. Were you involved in the first 20 clinical studies in connection with Fluoxetine 21 Hydrochloride? 22 A. No. 23 Q. Who was? 24 A. Doctor Shulman. Page 69 1 Q. Doctor Shulman? 2 A. Uh-huh. 3 Q. Can you spell that for us? 4 THE WITNESS: Is it with or without a 5 C, Mary? 6 MS. HUFF: I think it's without. 7 A. S-H-U-L-M-A-N. 8 Q. What was Doctor Shulman's 9 first name? 10 A. I think he was Robert, I'm not 11 sure. 12 Q. Is he still alive? 13 A. I think so. 14 Q. Where does he live? 15 A. Somebody mentioned that he 16 might be in Maine, he's a man who's moved an 17 awful lot in recent years. 18 Q. Would it be accurate to say 19 that Doctor Shulman was your predecessor in 20 connection with the clinical trials of Prozac? 21 A. It depends on how you 22 determine the word predecessor, but I guess so. 23 Q. He was the one responsible for 24 administration of the clinical trials just before Page 70 1 you? 2 A. Yes. 3 Q. Was there anybody that was 4 responsible for the administration of the 5 clinical trials before Doctor Shulman that you 6 were aware of? 7 A. Yes, of course, Doctor 8 Lemberger. 9 Q. Was Doctor Lemberger involved 10 in Phase 1 or Phase 2? 11 A. Phase 1. 12 Q. Was Doctor Shulman in Phase 1 13 or Phase 2? 14 A. Phase 2. 15 Q. What is your understanding of 16 the difference in Phase 1 and Phase 2 clinical 17 trials? 18 A. Phase 1 is to establish in 19 general terms the safety and the bioviability and 20 life of a compound in the patient. 21 MR. ARMSTRONG: Anything else? 22 THE WITNESS: It determines how a 23 compound is handled by normal people from which 24 one can infer duration of action and so on. Page 71 1 Q. Well, in the Phase 1 clinical 2 trials under Doctor Lemberger, would it be 3 accurate to state that all of the subjects, all 4 the individuals who had participated in the Phase 5 1 clinical trials were individuals that would be 6 considered normal, healthy individuals? 7 A. I can't swear to it but I 8 would assume so. 9 Q. In other words those Phase 1 10 clinical trials should exclude individuals who 11 were suffering from a diagnosis of depression? 12 A. Presumably. 13 Q. Did you do any work at all in 14 connection with the Phase 1 clinical trials? 15 A. No. 16 Q. Do you recall when the Phase 2 17 clinical trials began? 18 A. No, but I would guess in 19 retrospect that it would be about 1976. 20 Q. And in the Phase 2 clinical 21 trials, would it be accurate to state that that 22 would be the first time that human beings who 23 were suffering from depression were first given 24 Fluoxetine Hydrochloride, later known as Prozac? Page 72 1 A. Yes, I think so. 2 Q. Why did you become the medical 3 monitor or clinical trial administrator of 4 Fluoxetine Hydrochloride in 1978? 5 A. Doctor Shulman had done very 6 few studies and had determined that he was unable 7 to demonstrate any clinical efficacy. We in 8 pharmacology and in the preclinical research 9 components were very unhappy because we felt that 10 these studies had been inadequate and we made our 11 unhappiness known. When there was a 12 reorganization in which I was totally removed 13 from administrative responsibility, the director 14 of medical research indicated that since I was 15 going to retire in another year, would I be 16 willing during the last year of my employment to 17 make some attempt to determine whether the 18 company should or should not have further 19 interest in Fluoxetine. Is that clear? 20 Q. Yes. Who was this individual? 21 A. The name is Doctor Ian, I-A-N, 22 Shedden, S-H-E-D-D-E-N. 23 Q. And what was Doctor Shedden's 24 title at that time? Page 73 1 A. He was a vice-president in 2 charge of medical affairs. This may not be 3 accurately his title but defines his 4 responsibilities as I remember them. 5 Q. Is Doctor Shedden still with 6 Eli Lilly and Company? 7 A. No. 8 Q. Is he still alive? 9 A. I don't know. 10 Q. Where was he when you last saw 11 him? 12 A. He had gone back to England. 13 Q. When did he leave Lilly as far 14 as you know? 15 A. About 1983 I would guess, 16 maybe '84. 17 Q. Did he go back to England with 18 Lilly or did he cease his employment with Lilly 19 and move back to England? 20 A. He ceased his employment. 21 Q. Was he an older or younger 22 gentleman than you? 23 A. I think a little bit younger 24 than I. It got to the stage where almost Page 74 1 everybody was younger than I. 2 Q. Well as I understand it from 3 what you said, Doctor Shulman's work in the 4 opinions of you who were involved in the 5 preclinical studies was not adequate, it had 6 demonstrated that Fluoxetine Hydrochloride was 7 not efficacious in treating individuals who were 8 depressed, is that right? 9 A. Yes. 10 Q. And you and others in your 11 group believed that his work was either erroneous 12 or had not been done with enough insight or vigor 13 to demonstrate the efficacy of this product as an 14 antidepressant? 15 A. Yes. 16 Q. Who was joining you at this 17 time in raising these concerns with respect to 18 the early Phase 2 clinical trials done by Doctor 19 Shulman? 20 A. Doctor Fuller, Doctor Wong, 21 Doctor Molloy and so on, the people who had 22 worked so hard in the preclinical phases. 23 Q. How did you and Fuller, Wong, 24 and Molloy voice your concerns in this Page 75 1 connection, did you write memos, did you write 2 rebuttals to the clinical trials that were done 3 under Doctor Shulman, how did you make this 4 known? 5 A. I won't swear to the thing, 6 but I think we did a great deal deal of bitching 7 around the company. 8 Q. I was trying to avoid saying 9 that even though that's what I was hinting at. 10 How did you make your bitching known to your 11 boss? 12 A. I really don't remember but we 13 apparently got the point across. 14 Q. Was Doctor, is it Shedden? 15 A. Shedden. 16 Q. Was Doctor Shedden your 17 immediate supervisor? 18 A. No, no. 19 Q. Who was your immediate 20 supervisor at this time? 21 A. At this time a man named 22 Douglas Morton, although I reported directly to 23 Erving Johnson, I guess. 24 Q. What did you bitch at Douglas Page 76 1 Morton and Irvin Johnson? 2 A. I talked to Doctor Johnson 3 about it. 4 Q. What did Doctor Johnson do 5 about it? 6 A. I don't know. 7 Q. Did you also complain to 8 Doctor Shedden? 9 A. No, I don't think so. I 10 really didn't recall exactly how all this -- how 11 we succeeded in our campaign to make our 12 unhappiness known. 13 Q. And your campaign -- actually 14 you were in a campaign to further the clinical 15 trials to demonstrate the efficacy of Fluoxetine 16 Hydrochloride? 17 A. To test the hypothesis that 18 interfering with serotonin reuptake would be a 19 useful way to treat some depressed patients. 20 Q. As I understand it, the early 21 clinical trials done by Doctor Shulman failed to 22 demonstrate any efficacy in treating depressed 23 patients, is that right? 24 A. Yes. Page 77 1 Q. But you felt that the 2 medication that is influencing serotonin would 3 indeed if brought further along would demonstrate 4 some capacity or propensity? 5 A. To help people. 6 Q. To help depressed individuals? 7 A. Yes. 8 Q. So was their thought of 9 discontinuing clinical trials on Fluoxetine 10 Hydrochloride completely at this time? 11 A. They had been completely 12 discontinued. 13 Q. When was that that they 14 completely discontinued the early Phase 2 15 clinical trials? 16 A. 1977. 17 Q. Who would have been 18 responsibility for making that decision? 19 A. Doctor Shulman. 20 Q. What was Doctor Shulman's 21 position at that time? 22 A. I guess he was -- had the 23 title -- he was the senior physician assigned to 24 do research on drugs expected to have benefit in Page 78 1 patients with various medical illnesses. He was 2 formerly trained as a psychiatrist. 3 Q. Do you know who Doctor Shulman 4 would have been responsible to? 5 A. Doctor Marsden. 6 Q. Who? 7 A. M-A-R-S-D-E-N. 8 Q. What was Doctor Marsden's 9 first name? 10 A. I don't remember, I'm sorry. 11 Q. It won't help you to look at 12 her, she won't help you. She never has helped 13 me. 14 A. I think he's John. 15 Q. All right. 16 A. If I'm wrong, will she help 17 me? 18 Q. No, sometimes she'll start 19 throwing things at me, but see she believes I'm 20 wrong all the time. 21 Would Doctor Shulman have had 22 to secure Doctor Marsden's approval to 23 discontinue the Fluoxetine trials as he did? 24 A. Presumably. Page 79 1 Q. Is Doctor Marsden still with 2 Lilly? 3 A. I don't know, he's a little 4 bit younger than I am but he may have reached 5 retirement age. 6 Q. Mary might help you here. 7 That's not her job to help me. I'm not going to 8 ask her, she's a nice lady but that's not her 9 function here to help me. 10 Did you talk to Doctor Shedden 11 before he came to you and made this proposal to 12 you? 13 A. No, I don't think so. 14 Q. Why don't you think it over. 15 A. No, I was sort of surprised 16 when he invited me. 17 Q. Give me the details of how 18 that came up, your conversations with him. 19 A. My recollection was that I was 20 invited to come to his office and I wondered what 21 he wanted to see me about. 22 Q. Why was that, because he was 23 such a bigwig? 24 A. No, because it was not Page 80 1 something that I had been invited to do before. 2 Q. All right. 3 A. And I should perhaps mention 4 that several years before when Doctor Shedden 5 first came to Lilly, I had told him about the 6 activity of Fluoxetine in animals and I was 7 pleased that he as a clinician clearly understood 8 the implications of the findings that we had and 9 seemed to be interested. And so when I went to 10 his office, I knew that this was a man who 11 understood what problems were and he said to me, 12 Irv, would you be willing during the months that 13 you will still be with Lilly to undertake 14 supervising a clinical trial to determine whether 15 Fluoxetine might or might not be an active drug. 16 My mission was clearly limited to making the 17 decision, should we do extensive trials with this 18 drug or should we accept the decision to 19 discontinue. 20 Q. All right, so the decision had 21 been made to discontinue? 22 A. Yes. 23 Q. By Doctor Shulman? 24 A. Yes. Page 81 1 Q. The psychiatrist who had been 2 doing the early Phase 2 trials in connection with 3 depressed individuals, is that right? 4 A. Yes. 5 Q. But there was some, I guess 6 I'm having trouble, was -- how did Doctor Shedden 7 come to review that decision? Was there such an 8 uproar about that decision to kill the clinical 9 trials that he reevaluated Doctor Shedden's 10 decision? 11 A. I really don't know. 12 Q. You just don't know that? 13 A. That's his mind, not mine. 14 Q. I thought there might have 15 been a series of memos or series of discussions 16 maybe between you and Doctor Fuller, Wong and 17 Molloy in connection with this. 18 A. We discussed it among 19 ourselves but I don't know how word got around. 20 Q. You don't know why Doctor 21 Shulman happened to come in and -- I mean Doctor 22 Shedden or Sheeden? 23 A. Shedden. 24 Q. Shedden happened to come in Page 82 1 and override Doctor Shedden's decision? 2 MR. ARMSTRONG: Shulman. 3 Q. Doctor Shulman's decision to 4 discontinue the clinical trial? 5 A. No. 6 Q. Was Doctor Shedden a 7 psychiatrist? 8 A. Not to my knowledge. 9 Q. But Doctor Shulman was? 10 A. Yes. 11 Q. You mentioned something that 12 he wanted you to conduct these trials because you 13 were going to retire, is that right? 14 A. Yes. 15 Q. Did he say why your retirement 16 would have any affect on you being the man with 17 the responsibility for directing these Phase 2 18 clinical trials on depressed individuals? 19 A. It was to be a limited effort. 20 Q. In what respect was it to be a 21 limited effort? 22 A. We were only to have funds 23 sufficient to secure three investigators and 24 collect enough clinical data to enable a final Page 83 1 decision on whether to continue or discontinue 2 the drug trials. 3 Q. What happened to Doctor 4 Shulman? 5 A. He left Lilly and took a job 6 in a San Antonio firm. 7 Q. Texas? 8 A. Yes. That's the only San 9 Antonio I ever heard of. 10 Q. And you hadn't heard from him 11 since he went down to the Alamo city? 12 A. No. 13 Q. You don't correspond with him 14 or anything of that nature? 15 A. No. 16 Q. Did you have any kind of 17 strong or harsh disagreement with Doctor Shulman 18 concerning this yourself? 19 A. No. 20 Q. Did you ever confront him and 21 say, Doctor Shulman, I think you're wrong in this 22 decision to kill the clinical trials on Prozac? 23 A. I can't recall ever having 24 talked to him about it. Page 84 1 Q. But you did talk to other 2 individuals at Lilly in connection with your 3 opinion? 4 A. Because he left the company 5 rather soon after his exposure to Fluoxetine, I 6 think he stayed with Lilly only for a year or 7 two. 8 Q. Was he fired? 9 A. No, he had a -- he just moved 10 on. 11 Q. Okay. So you were going to 12 get three investigators? 13 A. Uh-huh. 14 Q. And you were going to collect 15 only enough data to determine whether or not the 16 studies should continue, is that right? 17 A. I don't like the emphasis on 18 the only, but to collect enough data. 19 Q. You thought -- the reason I 20 said only was not to try to put words in your 21 mouth but to properly characterize it because I 22 thought that you were going to have limited funds 23 and since this decision was being reviewed and 24 since you were only going to have a short time Page 85 1 there yourself, that this was something that you 2 were going to have some specific parameters with 3 respect to the time you could spend and the money 4 that you could spend on this project. 5 A. Yes. 6 Q. Is that accurate? 7 A. Yes. 8 Q. And so you were going to 9 collect in the short time and money that you had 10 a somewhat limited amount of, data in connection 11 with the clinical trials that you were going to 12 do, correct? 13 A. Yes. 14 Q. Those three investigators that 15 you hired, who were they? 16 MR. LORE: Sorry, Paul, I think we 17 have taken the position and I think it's one 18 that's been ruled on by the court in our favor, 19 that the only investigators that we're going to 20 talk about are the ones named as pivotal 21 investigators. I don't have any idea who the 22 investigators were, whether or not they were 23 pivotal or not, but I'm going to object to your 24 going into it on the grounds that they may not be Page 86 1 pivotal investigators. If you've got names, then 2 that's another issue. 3 MR. SMITH: My question was, who were 4 the three investigators that did the work on 5 this. 6 MR. LORE: I'm going to raise an 7 objection and also instruct him not to answer 8 that question. 9 MR. SMITH: I don't think you can 10 instruct him. 11 MR. ARMSTRONG: I'll make the 12 formality. As I understand it it's been ruled 13 upon by the court that you're not entitled to 14 examine unless you can show me that Mister Lore 15 is wrong on the point, then I think it's 16 inappropriate and I will direct the witness not 17 to answer the question. By the way, I recognize 18 that directing witnesses not to answer is not 19 specifically called for. If this is such a 20 critical part of your examination that you cannot 21 proceed without it, then we can adjourn and let 22 the court makes the determination. If it's not, 23 he can proceed but he's not going to answer your 24 question. Page 87 1 Q. Are you going to follow your 2 lawyer's advice and not answer the question on 3 who the three investigators were that you hired 4 to determine whether or not clinical studies 5 should continue in connection with testing human 6 individuals who were depressed on Prozac? 7 A. Of course. 8 Q. All right. Do you know 9 whether or not any of the three investigators 10 that you hired ended up or were investigators who 11 were connected with pivotal studies in connection 12 with Fluoxetine Hydrochloride? 13 A. At my stage of legal 14 knowledge, I don't know what the word pivotal 15 means. 16 Q. All the studies that you were 17 ever involved with in connection with Fluoxetine 18 Hydrochloride were pivotal in the scientific 19 word, weren't they, Doctor Slater? 20 A. It depends on how the word 21 pivotal is defined. 22 Q. Pivotal from the scientific 23 standpoint those three studies or those three 24 investigators that you hired to do studies were Page 88 1 pivotal to whether or not Fluoxetine 2 Hydrochloride research would go on. 3 MR. ARMSTRONG: Let me object. I 4 understand that the term pivotal has specific 5 meaning in the scheme of things. If you want to 6 use the term and try to entrap, for want of a 7 better term, the witness into identifying studies 8 as pivotal, I think you're obliged to furnish him 9 with specific definitions of the term. 10 MR. SMITH: The witness has already 11 testified he didn't have any idea what pivotal 12 investigators mean. 13 MR. ARMSTRONG: I know that, but you 14 do know we do, everybody else at the table who is 15 familiar with the subject, knows that it's a 16 specific defined term for use in the regulatory 17 scheme, don't they, isn't that a fair statement? 18 MR. SMITH: I'm questioning him on 19 what he means by pivotal. 20 MR. ARMSTRONG: I'm not going to 21 permit the use of such a term unless you disclaim 22 any meaning which relates to the regulatory. 23 MR. SMITH: I'm not characterizing it 24 as regulatory or not regulatory. I'm trying to Page 89 1 characterize it -- 2 MR. ARMSTRONG: Why don't you ask him 3 as significant or important. 4 MS. MORTIMER: Let him finish. 5 MR. ARMSTRONG: I'm not going to let 6 him answer the question when it's framed in the 7 context of a specific definition. 8 MR. SMITH: The reason I'm using the 9 word pivotal is because pivotal was used in the 10 objection. Pivotal has a certain term that's in 11 controversy among the parties as to what it means 12 with respect to the FDA, and I'm not trying to 13 get into whether or not I'm right or Steve is 14 right in connection with what is the proper 15 definition of pivotal, but if you'll let me 16 complete my question, counselor, my question is 17 what his impression is of whether or not it's 18 pivotal or not. I can ask him that under the 19 court's ruling in connection with what he thinks 20 is pivotal or not in connection with the studies, 21 absolutely. 22 MR. ARMSTRONG: You can phrase your 23 question any way you want to, I think it's not 24 inadvertent you're using a term which has been Page 90 1 defined. 2 MR. SMITH: Absolutely not. 3 MR. ARMSTRONG: Both in the 4 regulations and addressed by the court on a 5 specific point and that's what I find offensive. 6 If you wanted to ask him -- 7 MR. SMITH: I haven't even begun to be 8 offensive. 9 MR. ARMSTRONG: I don't think you're 10 capable of it. 11 MR. LORE: Lilly joins in all of those 12 objections and would also -- I would also state 13 that Mister Smith knows what we mean by pivotal 14 studies. The pivotal studies with respect to 15 names of investigators have been identified to 16 the FDA. It's not the approval, summary basis of 17 approval, those names are listed, there's been a 18 lot of discussion about those names and about the 19 investigators who are not listed and 20 investigators doing studies that were submitted 21 to the FDA formed the basis of, summary basis of 22 approval. 23 Q. Do you remember the names, 24 without giving me the names right now, do you Page 91 1 remember the names of the three investigators 2 that you hired to conduct these clinical trials? 3 A. Yes. 4 Q. And do you remember whether or 5 not those were individuals that were located in 6 Indianapolis or were located outside of 7 Indianapolis? 8 THE WITNESS: Am I supposed to answer 9 that? 10 MR. ARMSTRONG: I think you can answer 11 that. 12 A. They were all outside of 13 Indianapolis. 14 Q. In what cities were these 15 investigators located? 16 THE WITNESS: Am I supposed to answer 17 that? 18 MR. ARMSTRONG: I don't know, I'll 19 have to hear from you, Steve, on this issue. I 20 don't know whether or not, if you've got a list 21 of the names of the people, why don't you ask him 22 that or is that such a long list? 23 MR. SMITH: I object. Either make an 24 objection or what you're saying would be a side Page 92 1 bar remark and I object to your side bar remarks. 2 If you want to stop and have a conference with 3 the witness or with the Lilly lawyers -- 4 THE WITNESS: Let's have a conference, 5 may we? 6 MR. SMITH: I'm obviously entitled to 7 know where the investigators live under any 8 stretch of the court's judgment. 9 MR. LORE: I would say no, that would 10 be something that would identify the 11 investigators. 12 MR. SMITH: How? 13 MR. LORE: The cities, if you go back 14 and determine how many cities there were, we 15 didn't have that many investigators. 16 MR. SMITH: They were all over the 17 country. 18 THE WITNESS: But there were a limited 19 number of investigators used. 20 Q. Where were the three 21 investigators located? 22 A. Outside of Indianapolis. 23 Q. What cities? 24 MR. ARMSTRONG: I object and I direct Page 93 1 him not to answer the question on the same 2 grounds that I stated earlier. This relates to a 3 ruling which I understand has been made by the 4 court which precludes you from determining the 5 identity of any investigator except a pivotal 6 investigator. 7 MR. SMITH: Have you seen such a 8 ruling, Counselor? 9 MR. ARMSTRONG: I'm aware of it. Are 10 you denying that such a ruling exists? 11 MR. SMITH: No, my question is have 12 you seen such a ruling. 13 MR. ARMSTRONG: I'm aware it exists. 14 MR. SMITH: By virtue of conversations 15 with Lilly lawyers? 16 MR. ARMSTRONG: By counsel, certainly. 17 I'm not a counsel in these proceedings. 18 MR. SMITH: My question is whether or 19 not these were pivotal investigators, not what 20 their name was. 21 Q. My question is, of these three 22 investigators you hired, where, in what cities 23 did these three investigators -- 24 MR. ARMSTRONG: I object. Page 94 1 MR. SMITH: Let me finish my question 2 and I object to you continuing to cut me off. 3 Q. What city did these three 4 investigators live in? 5 MR. ARMSTRONG: I object to the 6 question. 7 THE WITNESS: May I raise a different 8 problem? I have to go to the bathroom. 9 MR. ARMSTRONG: That supervenes. 10 (A SHORT BREAK WAS TAKEN.) 11 Q. (BY MR. SMITH) My question 12 is, what were the sites or where did the three 13 investigators that you hired in these early Phase 14 2 studies when you first took over the Fluoxetine 15 studies, where were the investigators located 16 that you hired? 17 MR. ARMSTRONG: I'll repeat the 18 objection and the instruction to the witness. 19 MR. SMITH: Which was? 20 MR. ARMSTRONG: Which was not to 21 answer the question. 22 Q. Were these the investigators 23 that had done studies on Fluoxetine Hydrochloride 24 prior to being hired by you in 1978? Page 95 1 A. I'm not sure, but I think the 2 answer is no. 3 Q. They were new investigators? 4 A. Yes. 5 Q. How did you select these three 6 individuals as investigators? 7 A. They were recommended to me by 8 members of the group who had been reading the 9 literature. 10 Q. Who were the members of the 11 group that recommended these three investigators? 12 A. Doctor Stark and Doctor 13 Fuller. 14 Q. What was Doctor Stark's 15 function at the time you took over the Prozac, 16 Fluoxetine Hydrochloride clinical studies? 17 A. I think at that time Doctor 18 Stark had been assigned to the medical division 19 as an individual who would supervise clinical 20 trials of various types. 21 Q. Well, do you know whether or 22 not Doctor Stark had supervised any Fluoxetine 23 clinical trials prior to your taking over? 24 A. Yes, I do know. Page 96 1 Q. Had he? 2 A. No. 3 Q. Doctor Stark is not a medical 4 doctor, is he? 5 A. He is not. 6 Q. Doctor Fuller is not a medical 7 Doctor either, is he? 8 A. No. 9 Q. But you took those 10 individuals' recommendations as individuals who 11 could recommend particular investigators for this 12 resumption of clinical trials? 13 A. Yes. 14 Q. On Fluoxetine, is that 15 correct? 16 A. Yes. 17 Q. And again, you're not a 18 psychiatrist? 19 A. I'm not a psychiatrist. 20 Q. You're a medical doctor but 21 not a psychiatrist? 22 A. Yes. 23 Q. And you had not participated 24 in any clinical trials on human individuals in an Page 97 1 administrative capacity prior to being asked by 2 Doctor Shulman? 3 MR. ARMSTRONG: Shedden. 4 Q. Shedden, to take over the 5 Fluoxetine clinical trials, is that right? 6 A. Except for the studies that I 7 had done at Rochester, and those were not in an 8 administrative position. 9 Q. Did you do anything else to 10 secure the three investigators other than talk to 11 Doctor Stark and Doctor Fuller? 12 A. I don't remember. 13 Q. Do you know where Doctor Stark 14 and Doctor Fuller got the names of these 15 individuals that were hired to do this 16 investigation? 17 A. Doctor Stark had had contact 18 with some of these people before. 19 Q. Was Doctor John Feighner one 20 of the individuals who was hired by you to do one 21 of the studies? 22 A. No. 23 Q. Was Doctor Louis Fabre one of 24 the individuals that was asked to do one of the Page 98 1 studies? 2 A. Yes. 3 Q. And Doctor Fabre is in 4 Houston, Texas? 5 A. Yes, he was then. I don't 6 know if he is now. 7 Q. He's still there, in between 8 trips to Mexico, he still practices in Houston, 9 Texas. What were the protocol numbers that these 10 three investigators did in these studies? 11 A. What do you mean by protocol 12 numbers? 13 Q. Well, the new investigators 14 did studies according to protocols, did they not? 15 A. Yes, I guess. 16 Q. What is your understanding of 17 what a protocol is? 18 A. It's a plan of how you're 19 going to do an experiment. 20 Q. It's sort of the blueprint for 21 the study, isn't it? 22 A. Yes. 23 Q. Do you know what the protocol 24 numbers were that these three investigators did Page 99 1 their studies by? 2 A. No. If I did, I don't know it 3 now. 4 MR. LORE: I would also like to 5 object. There's no basis as far as I know that 6 they were in fact, that they had protocol numbers 7 at this point in time. You're assuming in your 8 question that there were protocol numbers 9 assigned to these studies and I don't know if 10 that's in evidence yet so I would object on those 11 grounds. But with that objection he's already 12 answered your question. 13 Q. Were there any Phase 2 14 clinical trials, Doctor Slater, that you were 15 aware of that were done according to protocols 16 that were eventually at least numbered? 17 A. The term protocol numbers is 18 totally unfamiliar to me at this point. It means 19 nothing. 20 Q. Did you do any research 21 yourself in connection with how to conduct a 22 clinical trial on humans before you began 23 administration of the Fluoxetine clinical trial? 24 A. I'm not sure I understand what Page 100 1 you mean. 2 Q. Did you do any research -- I 3 understand you talked to Doctor Stark and Doctor 4 Fuller about individuals to hire to do these 5 clinical trials? 6 A. Oh, I did considerable reading 7 in the field to see how such studies were being 8 done but I don't think I could cite page and 9 reference to what I read twenty years ago. 10 Q. What was the subject of your 11 reading then? 12 A. The subject was what kind of 13 questionnaires you administered to patients that 14 determined the state of their depression and so 15 on. Or there were then several forms that 16 psychiatrists had developed for use in this kind 17 of study. 18 Q. You've not seen or used any of 19 those forms though, had you, Doctor Slater, prior 20 to being hired in 1978 to revive the clinical 21 trials on Fluoxetine? 22 A. I didn't think cats could 23 respond to them. 24 Q. So the answer to my question Page 101 1 is, you had not seen any of those human 2 questionnaires that would be administered to 3 humans involved in clinical trials, had you? 4 A. No, not prior to undertaking 5 this responsibility. 6 Q. Before this, you had never 7 administered any of these tests to humans to see 8 whether or not their depression was getting 9 better or worse, had you? 10 A. No. 11 Q. You didn't know how to do that 12 either, did you? 13 A. No, but I didn't know how to 14 do cat studies before I started doing them 15 either. 16 Q. Did you learn how to 17 administer these questionnaires and these 18 psychiatic tests to subjects participating, human 19 subjects participating in the clinical trial? 20 A. I didn't attempt to make 21 myself able to do the trials, administer the 22 questionnaires, but I did develop knowledge 23 sufficient to feel comfortable in discussing 24 results with investigators who were capable of Page 102 1 administering them. 2 Q. But you were a result-oriented 3 researcher as opposed to a psychiatrist that went 4 out and actually did the clinical trials, is that 5 correct? 6 A. Yes. 7 Q. For instance, to draw analogy 8 in or background back in the early 1950's, you 9 administered Thorazine to some patients of yours 10 to determine whether or not that Thorazine was 11 capable of helping them with some of their 12 movement disorders caused by cerebral palsy? 13 A. Yes. 14 Q. You were actually hands on 15 administering the medication, correct? 16 A. Yes. 17 Q. You were hands on observing 18 the patient, correct? 19 A. Yes. 20 Q. In these clinical trials that 21 you were going to be doing with Fluoxetine, the 22 hands on work and actual observation of the 23 patient was going to be done by one of the 24 investigators, wasn't it? Page 103 1 A. Yes. 2 Q. You didn't have any idea 3 really, did you, Doctor Slater, how to make a 4 psychiatric observation in connection with 5 respect to whether or not an individual's 6 depression was becoming worse or better, did you? 7 A. Well, I think that I had done 8 enough reading so that I would be able to 9 intelligently evaluate the significance of a 10 report from a competent psychiatrist. 11 Q. I understand that. 12 A. But I personally was not a 13 psychiatrist. 14 Q. And as far as you being able 15 to administer these tests, you couldn't? 16 A. Probably not, but I'm not 17 sure. 18 Q. I'm not trying to be critical 19 of you, Doctor, but your specialty was different. 20 A. Yes. 21 Q. You were not a psychiatrist, 22 were you? 23 A. Yes. 24 Q. And frankly you didn't have Page 104 1 any idea how to administer a Hamilton depression 2 scale test to a patient, did you? 3 A. I think you're putting it a 4 little bit more broadly, I'm not quite that 5 ignorant. 6 Q. You knew what the questions 7 were? 8 A. I knew what the questions 9 were, I knew what the scales purported to show 10 and how in the literature these were evaluated. 11 Q. But as far as coming to a 12 clinical diagnosis with respect to any particular 13 individual concerning whether or not their 14 depression was getting better or worse, you 15 weren't trained to do that, were you? 16 A. I was not trained. 17 Q. And didn't do it and couldn't 18 do it, could you? 19 A. The scales purport to show 20 improvement or worsening by the numbers that come 21 out of the scale and where the numbers come from. 22 I felt competent to say that if the scale in the 23 opinion of the psychiatrist seemed to show no 24 effect because there were no changes, I could Page 105 1 answer that. If they seemed to show substantial 2 improvement because of changes in scale, I could 3 look at the scale and say this looks like an 4 honest interpretation of the data, and if they 5 had shown worsening of the thing, I think I would 6 have felt competent to do that. So I was not an 7 ignorant dolt suddenly. 8 Q. And that's not the implication 9 of my question, Doctor Slater. My point simply 10 is that for instance the Hamilton depression 11 scale is reported as a total of an arithmetic 12 scale, is it not? 13 A. Yes. 14 Q. But to put any particular 15 numbers to any particular area of the twenty-one 16 or twenty-nine different areas that the Ham D 17 evaluates, you were not trained to score any 18 particular area, correct? 19 A. All right. 20 Q. Is that correct? 21 A. Yes. 22 Q. In fact, you had never heard 23 of the Hamilton Depression Scale before you were 24 asked in 1978 to revive the clinical trials on Page 106 1 Fluoxetine. 2 A. Probably not, but I did not 3 remember. 4 Q. You had never heard of the 5 COVI insight scale? 6 A. No. 7 Q. You had never heard of the 8 patient's global impression as part of any 9 psychiatric examination to determine whether or 10 not a patient was becoming more or less 11 depressed, had you? 12 A. Probably not. 13 Q. Do you remember, when was it, 14 1977 or 1978 that you were asked by Doctor 15 Shulman to undertake this project? 16 A. Doctor Shedden, in 1978. 17 Q. And when in 1978 was that, 18 early? 19 A. Late. 20 Q. Late. And then you retired 21 December 31st, 1979? 22 A. Yes. 23 Q. During that period of time, 24 late 1978 to late 1979, did you do any other work Page 107 1 for Eli Lilly and Company other than administer 2 the clinical trials? 3 A. I had my laboratory and I was 4 doing experiments in animals. 5 Q. What type of experiments were 6 you doing? 7 A. I really don't remember. 8 Q. They weren't related to 9 Fluoxetine or Prozac, were they? 10 A. I don't know. 11 Q. What percentage of time was 12 devoted to your lab experiments versus your 13 clinical trial? 14 A. About half and half. 15 Q. From 1976 until late 1978 when 16 Doctor Shulman was conducting the Fluoxetine 17 trials, were you reviewing that work as it was 18 being done, those clinical trials? 19 A. No, not to my recollection. 20 Q. Were you aware of the status 21 of those clinical trials at any particular time? 22 A. Not really. 23 Q. Before you were asked by 24 Doctor Shedden in late 1978 to take over the Page 108 1 Fluoxetine trials, were you a member of the 2 Fluoxetine team? 3 A. Yes. 4 Q. All right. In what respect? 5 A. I had been actively 6 participating in the discussions and were doing 7 cat experiments and all the things that I have 8 described. 9 Q. We have some Fluoxetine 10 meetings is the reason I was asking, you were on 11 those Fluoxetine team meetings beginning in 1976, 12 I think. 13 A. Now that you used the term 14 Fluoxetine team, I have to say, one, that I don't 15 remember because the term team may have a 16 different implication, because when the company 17 set up a project for clinical trials, a group of 18 investigators who had -- would participate in the 19 supervision, somebody from pharmaceutical 20 development, somebody from analytical, somebody 21 from pharmacology, somebody from the clinic and 22 so on would constitute the team and I do not 23 remember being a formal member of that particular 24 team. If we refer to the team in the more Page 109 1 general sense that we're a team of people 2 interested in this project, then I was a member 3 of that group, but out of the formal research 4 team. Is that clear? 5 Q. Sure. And I thank you for 6 expanding on that. Have you seen the final 7 reports or the results of Doctor Shulman's 8 clinical trials? 9 A. No. 10 Q. You simply knew that the 11 result was that it failed to demonstrate efficacy 12 for Fluoxetine in treating depression, is that 13 right? 14 A. Yes. 15 Q. I need for you to review with 16 me what you did to get a plan of a clinical trial 17 started through the use of a protocol, what was 18 the first thing you did to secure a protocol to 19 run one of these clinical trials? 20 A. That's almost -- well, it's 21 about seventeen, eighteen years ago and to answer 22 accurately it's beyond me. I think what we did 23 was review the various scales that you have 24 mentioned, decided which ones we would like to Page 110 1 use and what information, ancillary information 2 to the scale we would like the investigators to 3 report to us, and with that type of thing, I 4 think we wrote protocols. And I have no clear 5 recollection of writing the protocol but I 6 suspect I did, and I suspect I discussed it with 7 the people in the medical group who had more 8 experience in writing protocols and with the 9 people in the Fluoxetine group who were 10 interested in this kind of thing. That's the 11 best I can do. 12 Q. When you say we, we reviewed 13 scales, we selected scales and we secured 14 ancillary information, who are you referring to 15 in connection with we when you say we? 16 A. The people who I considered to 17 be my friends and colleagues, Doctor Fuller, 18 Doctor Stark, Doctor Molloy, and the people in 19 the supervision and the medical group. I don't 20 think I discussed them in detail with Doctor 21 Shedden but Doctor Bendush was the man to whom or 22 from whom I actually got the money. 23 Q. Doctor Bendush? 24 A. Yes. Page 111 1 Q. Was the man from whom you got 2 the money? 3 A. He was the one who was the man 4 between Doctor Shedden and the -- in the 5 mechanics of setting up these because his 6 responsibility was for collecting such 7 information. 8 Q. Doctor Bendush was the one 9 that approved the funding for the study? 10 A. Uh-huh. 11 Q. Is that a yes? 12 A. Yes. 13 Q. When you say uh-huh. 14 A. Yes. 15 Q. When you see that written 16 down, you can't really tell what that means, 17 that's the reason I'm doing that with you. 18 Anybody, any other of your colleagues that you 19 reviewed these potentials that you worked with in 20 developing a protocol other than Doctor Fuller, 21 Doctor Stark and Doctor Molloy? 22 A. I don't remember. 23 Q. Did you consult with any other 24 psychiatrist to determine -- Page 112 1 A. I probably discussed it with 2 Doctor Bennett, Ivan Bennett, but I don't 3 remember having done so. 4 Q. Who is Doctor Ivan Bennett? 5 A. He's another psychiatrist who 6 worked for Lilly. 7 Q. Is he still employed by Lilly? 8 A. I think he's retired -- no, 9 he's dead. 10 Q. Do you have a specific 11 recollection with -- in connection with 12 discussing psychiatric issues with Doctor Bennett 13 in connection with the protocols that were going 14 to be done for these three studies? 15 A. Not specifically, no. 16 Q. But you do know that you 17 talked with Fuller, Stark and Molloy? 18 A. Uh-huh. 19 Q. How about Doctor Wong, did you 20 get his input on what would be appropriate 21 protocols? 22 A. I don't remember. 23 Q. Anything else you did in 24 developing these protocols for these studies? Page 113 1 A. I mentioned the reading that I 2 had done in the literature. 3 Q. Were you reading on how to do 4 clinical trials or were you reading on specific 5 serotonin reuptake inhibitors? 6 A. There was no literature on 7 serotonin reuptake inhibitors, we were the 8 literature. 9 Q. So is the answer to my 10 question you were reading up on how to do 11 clinical trials? 12 A. Yes. 13 Q. Do you remember anything 14 specifically that you read? 15 A. No. 16 Q. Did you take any old protocols 17 that had been used by your predecessor and use 18 those protocols for the protocols to be used in 19 the new studies? 20 A. Probably, but I'm not sure. 21 Q. Did you personally feel that 22 it was important to develop an appropriate 23 protocol to conduct these studies with? 24 A. Yes. Page 114 1 Q. Why? 2 A. Because it was a very simple 3 question we were asked to answer was is this a 4 drug worthy of a clinical trial. And I might 5 point out that all of this sort of annoys the 6 hell out of me because the FDA found that this is 7 an effective drug and we're not whistling up a 8 tree. 9 Q. What? 10 A. We were not whistling up a 11 tree. We were asked to determine is this 12 positively an antidepressant, and a world of 13 data, ten million patients indicate that this is 14 an effective drug and what the hell are we 15 fudtzing around about. You would agree that this 16 is an active compound. 17 Q. That it's an active compound, 18 I certainly would. 19 A. Then what the hell are we 20 doing? 21 Q. The question is the action 22 that it produces obviously. And, Doctor Slater, 23 let me say that it's not my purpose to irritate 24 you at all. If I irritate you, I'm sorry, but Page 115 1 that may just be the result of my questions in 2 doing my job for my client. But if you would 3 like to take a break, if you're feeling 4 frustrated or irritated, I would be glad to take 5 a break for you. 6 A. Go ahead, but let's get 7 somewhere. 8 Q. Beg your pardon? 9 A. Let's get somewhere. 10 Q. Then who made the final 11 decision with respect to the particular protocol 12 that was to be used in these studies? 13 A. I did. 14 Q. Did you submit that protocol 15 to review by anybody that was in a supervisory 16 capacity? 17 A. Almost certainly, but I don't 18 remember. 19 Q. Can you tell me who that would 20 have been? 21 A. That would have been Doctor 22 Bendush and Doctor Shedden and so on. 23 Q. We know there were three 24 investigators that were hired. Page 116 1 A. Yes. 2 Q. Were there three separate 3 studies done with three different protocols? 4 A. I think the same protocol was 5 more or less for each of the investigators, but I 6 wouldn't swear to that. 7 Q. Do you remember whether or not 8 a placebo was raised in the three studies? 9 A. The initial studies were open 10 without placebo but some of the studies did 11 include the use of placebo later. 12 Q. I'm talking about those 13 studies which you had supervisory capacity. 14 A. Yes, there was some placebo 15 controlled studies. 16 Q. Do you remember whether they 17 were blind or double-blind? Single-blind or 18 double-blind, I guess that's how you say it. 19 A. No. 20 Q. No, they were not blinded or 21 you don't recall? 22 A. I don't remember. If I had to 23 guess I would guess they were single-blind and 24 that the physicians knew but not the patients. Page 117 1 Q. Do you recall whether or not 2 there were comparitor drugs used? And by that I 3 mean whether Fluoxetine was compared with other 4 antidepressants. 5 A. Only in the sense that all the 6 patients had had many other drugs before to which 7 they had not responded. 8 Q. Well, I'm talking about other 9 drugs -- I'm talking about a comparitor drug 10 where some group is -- some members of the group 11 is given a placebo? 12 A. No. 13 Q. Some members of the group were 14 getting Fluoxetine and other members of the group 15 might be getting Imiprimine or things of that 16 nature. 17 A. No, that was not the nature of 18 my assignment as I indicated several times. 19 Q. How did you select the 20 patients? You say that all the patients had many 21 other drugs to which they had not responded. Was 22 that part of the protocol that they were to be 23 nonresponders to other antidepressant medication? 24 A. No, that was the nature of the Page 118 1 patient population which the investigators were 2 dealing. 3 Q. I guess my question is how did 4 you assure what the nature of the patient 5 population were? 6 A. I didn't assure it. 7 Q. That they were individuals 8 that had not responded to other antidepressant 9 therapy? 10 A. No, this was not a 11 prerequisite, but this was the population that 12 these investigators were dealing with for the 13 most part. 14 Q. My question is, did you know 15 that, was this something reported to you by the 16 investigators? 17 A. Yes. 18 Q. Was it your impression that 19 these were patients that were currently being 20 treated by these investigators for the mental 21 illness of depression or were these patients that 22 the investigator went out and secured? 23 A. Some of each. 24 Q. Do you recall whether or not Page 119 1 it was specified in any of the protocols the 2 duration for which the patients should have been 3 suffering from the illness? 4 A. No. 5 Q. And by that I mean whether or 6 not the person had been treated for depression or 7 experienced depression for six weeks, six months 8 or six years? 9 A. I don't recall. 10 Q. Do you have an opinion with 11 respect to whether or not that would make any 12 difference in the outcome of the clinical trials, 13 that is the duration of the individual's illness? 14 A. Yes, I think so. If you had a 15 patient who had failed to respond with three 16 other antidepressants, the probability of 17 responding to a fifth or sixth one would be 18 substantially less than if it were a patient who 19 had been depressed but never treated with a drug 20 because for obvious reasons. 21 Q. Were there any concomitant 22 medications being administered to the patients, 23 that you recall? 24 A. I don't recall, but I think Page 120 1 that -- 2 MR. ARMSTRONG: You mean as part of 3 the protocol or just incidently? 4 MR. SMITH: Either way. 5 A. Certainly not as part of the 6 protocol. 7 Q. Did you personally interview 8 these investigators that you hired? 9 A. Yes. 10 Q. Do you recall whether you went 11 to their site or whether they came to 12 Indianapolis? 13 A. I went to their sites. 14 Q. How many patients were 15 involved in these clinical trials, if you recall? 16 A. I can't be sure but I think 17 the idea was that each of them would probably do 18 about ten patients, five to ten patients. 19 Q. Why was the study limited to 20 five or ten patients? 21 A. It was hoped that we would be 22 able to reach a marginal decision on the basis of 23 that kind of number. 24 Q. Did you check with any of the Page 121 1 statisticians there at Lilly to determine whether 2 or not five -- a study involving five or ten 3 patients would be sufficient to determine 4 efficacy of Fluoxetine for treatment of 5 depression? 6 A. I didn't need a statistician 7 to tell me that five or ten patients would not be 8 an adequate number to establish efficacy. It was 9 obvious all we were going to accomplish was to 10 answer the question should we do such a study or 11 accept the fact that this was a dud. 12 Q. Your purpose in doing your 13 protocols and doing your studies was not to get 14 to the ultimate issue of whether or not 15 Fluoxetine was efficacious in treating 16 depression, but whether or not there was -- you 17 could generate enough data to even go toward that 18 question any further, is that correct? 19 A. Right, correct. 20 MR SMITH: Let's take a lunch break 21 and let me review some of this stuff at lunch. 22 (A LUNCH BREAK WAS TAKEN.) 23 Q. Doctor Slater, I would like to 24 go back to the paper you wrote which we're going Page 122 1 to mark as Exhibit 1 in connection with your 2 experiment on cats and their REM sleep, correct? 3 A. I haven't read that paper in 4 ten years and I just pulled it out of the file 5 last night. 6 Q. All right. I would like to 7 read with you a particular paragraph in that, I 8 don't mean to hover over you but I want you to 9 follow along with me in my reading and make sure 10 I read it correctly. I will be reading from page 11 385 from your article Inhibition Of REM Sleep By 12 Fluoxetine, A Specific Inhibitor Of Serotonin 13 Uptake. It was published in Neuropharacology, 14 Volume 17. Turning to page 385, you say, "After 15 the cats had been receiving drug treatment for a 16 few days, it was noticed that their pupils were 17 dilated, but still responsive to light. The 18 degree of mydriasis seemed to be dose-related. 19 By the fourth day of drug treatment, the cats 20 receiving the larger doses" -- and that's of 21 Fluoxetine, correct? 22 A. Uh-huh. 23 Q. "Which had been friendly for 24 years, began to growl and hiss. They became Page 123 1 distinctly unfriendly, but with careful handling 2 it was possible to administer the drug in the 3 usual way. The cats seemed to see clearly and 4 did not seem to be hallucinating. They became 5 less irritable at the end of the second week of 6 drug administration. After cessation of the drug 7 treatment, the cats returned to their usual 8 friendly behavior in a week or two; those on 9 higher doses recovering more slowly. The 10 severity of the behavioral change was dose 11 related being more severe and lasting longer in 12 the cats receiving the highest dose." Did I read 13 that correct, Doctor? 14 A. Yes. 15 Q. And does that accurately -- 16 what you wrote there accurately reflect at least 17 part of your findings in connection with the rat 18 study, it's -- I mean the cat studies where you 19 gave the cats Fluoxetine? 20 A. Yes. 21 Q. Did you ever do any 22 experiments or any studies to ascertain whether 23 or not any other animals would become angry and 24 exhibit these behavioral changes -- Page 124 1 A. No. 2 Q. -- when administered 3 Fluoxetine? 4 A. No. 5 Q. Then for instance did you do a 6 study -- 7 A. There were -- I don't know, 8 studies done in rats and in dogs but I didn't 9 supervise those studies. 10 Q. Are you aware of any studies 11 in monkeys who were administered Fluoxetine and 12 became agitated, angry and exhibited these 13 negative behavioral changes that you find in the 14 cats? 15 A. No. 16 Q. You do recognize that 17 agitation is a frequently cited side effect in 18 the clinical trials and in the post-marketing 19 experience with Fluoxetine, do you not? 20 A. I don't know anything about 21 those. 22 Q. As I understand it, you have 23 kept a diary of sorts in connection with your 24 work at Eli Lilly and Company? Page 125 1 A. Yes. 2 Q. And that diary contains 3 notations with respect to your work on Prozac or 4 Fluoxetine, is that right? 5 A. Yes. 6 Q. We have been handed in 7 response to a subpoena a document with fifty-four 8 pages that purports to be a copy of that diary, 9 is that right? 10 A. Yes. 11 Q. But it's not a complete copy? 12 A. Right. 13 Q. Is it? 14 A. It contains as far as I can 15 figure out all the information related to 16 Fluoxetine. 17 Q. But it's not all the 18 information out of your diary, is it? 19 A. No, of course not. 20 MR. SMITH: Let's mark this as exhibit 21 2. 22 (PLAINTIFFS' EXHIBIT NO. 2 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 126 1 Q. Doctor Slater, I'm going to 2 hand you and ask you to look at Exhibit 2 and 3 I'll ask you to identify that as a xerox copy of 4 your diary? 5 MR. ARMSTRONG: Let me object for 6 clarification, it's obviously not a xerox copy of 7 his diary, it's a xerox copy from his diary. 8 MR. SMITH: Excuse me. 9 Q. From your diary? 10 A. Yes. 11 Q. You better watch me, Doctor, 12 I'll trick you every time. It's a good thing you 13 got a lawyer that's on the ball, that's watching 14 that. You assume that you turned over your diary 15 to someone and then portions of your diary were 16 redacted, those pages were copied and then 17 bate-stamped and that's how we get what's marked 18 at Exhibit 2? 19 A. What happened was I received 20 your, or from the office of Ms. Mortimer, and I 21 read through the diary and marked on a separate 22 sheet of paper all the pages that I thought had 23 Fluoxetine related material and then I sent the 24 diary to Armstrong, he independently read the Page 127 1 diary and then made additional notes and then 2 together we went through the diary and marked 3 those portions that you see here. 4 Q. When was that done? 5 A. Last week and this week, I 6 guess. 7 Q. Where is the original of your 8 diary? 9 MR. ARMSTRONG: I have it. 10 Q. You have not received it back? 11 A. No, I have the portion that 12 goes -- he returned the portion that goes to 13 about 1963 or '64 which is wholly irrelevant. 14 Q. What was your habit in 15 connection with diary notations in your diary? 16 A. Well, the original note says 17 that everytime I have a difference of opinion 18 with people and they don't do what I tell them, 19 it usually turns out badly and that I ought to 20 write things down to determine whether indeed I 21 was right as often as I thought. And, oh, 22 whenever something came up where I thought I 23 would like to know what I was thinking about at 24 that time for later review, I put it in the Page 128 1 diary. There are a lot of personal things in the 2 diary about other projects. There are some 3 things about some of my friends who were having 4 problems wanting divorce, two divorces actually, 5 and that sort of thing where I predicted to 6 myself what I thought was going to happen to the 7 separated people, what I thought was going to 8 happen because of this drug study and that drug 9 study, it contains a large variety of nonsense. 10 Q. You didn't make daily 11 notations? 12 A. No, and there are very many 13 important things which are not in the diary. 14 Q. But the primary emphasis for 15 you making a notation in your diary would be that 16 if you wanted to recall something that was said 17 and be able to pull back your thoughts or what 18 was expressed to you at the later date, you would 19 have a written record of that? 20 A. Yes. 21 Q. How long have you been keeping 22 a diary or log such as this? 23 A. I think the initial entry is 24 1958. Page 129 1 Q. How long did you continue to 2 keep the diary? 3 A. There are some notations that 4 go to last year. 5 Q. 1993? 6 A. Uh-huh, which are obviously 7 unrelated to Fluoxetine. 8 Q. Would you normally keep this 9 diary at home and make notations in it at home or 10 would you carry it with you? 11 A. It was in my desk at work and 12 I never took it home until I had finished the 13 volume. There were three volumes and when I 14 finished the volume I took it home and its been 15 sitting in the guest room closet mostly unread. 16 Q. Did you go through your diary 17 in connection with your deposition here to 18 refresh your recollection? 19 A. I told you that I had. 20 Q. Did you need it to refresh 21 your recollection concerning events with respect 22 to your work on Fluoxetine? 23 A. Yes. After all, it's been 24 twenty years and I don't remember every detail. Page 130 1 There are some things that I remembered and some 2 things I said oh, my gosh. 3 Q. After you made your notes 4 concerning which entries had to do with 5 Fluoxetine and after you had the meeting with 6 Mister Armstrong, were there more entries deleted 7 from the notation than you had originally 8 intended to delete? Do you follow what I am 9 saying? 10 A. I don't think we added or 11 subtracted a significant amount. He may have 12 found a few things that I had missed, but 13 anything that he did added rather than subtracted 14 as far as I recall. Is that right? 15 MR. ARMSTRONG: That's right. 16 A. Sometimes I may have read 17 something too quickly and didn't recognize it for 18 what it was and he called it to my attention. We 19 didn't do any deletions of things, I think it's 20 as complete as it could be. 21 Q. My only question was did your 22 attorney make further and additional deletions 23 than you had made originally? 24 A. No, he only made additions. Page 131 1 Q. If you don't mind, I would 2 like to go through this with you briefly because 3 you write relatively legibly for a physician. 4 A. That's a dim compliment. 5 Q. But I can't read all of it and 6 I need to get some of these. 7 A. I hate to tell you but neither 8 can I. 9 Q. I need to get some of these 10 abbreviations, also. 11 It looks like the first 12 notation that might have to do with Fluoxetine is 13 November 12, 1970, is that correct? 14 A. Yes. 15 Q. And for review, you were 16 director of pharmacological research with Lilly 17 in November of 1970? 18 A. I think so. 19 Q. The first notation says 20 extended meeting of CNS core committee, and you 21 need to look at these notes too and see 22 that I'm reading them correctly. 23 A. Uh-huh. 24 Q. And what do you mean by CNS? Page 132 1 A. Central nervous system. 2 Q. Would that be a drug in which 3 Fluoxetine would fall? 4 A. That would be a field of 5 research. 6 Q. It says Stark, Rathbun, 7 Molloy, Slater and Fuller, correct? 8 A. Yes. 9 Q. Who is Owen? That name is not 10 familiar to me. 11 A. Mister Owen was -- Doctor 12 Rathbun and Mister Owen at this time were running 13 a behavioral laboratory and Mister Owen was 14 Doctor Rathbun's assistant. He is a man -- or he 15 was a man with a bachelors degree. 16 Q. It says lots of talk, 17 especially about interaction of drugs with -- 18 A. Apomorphine. 19 Q. Now is that a period after 20 that? 21 A. Yes. 22 Q. All right. What is 23 Apomorphine? 24 A. Apomorphine is a derivative of Page 133 1 morphine that stimulates dopaminergic receptors 2 and causes vomiting, particularly in people, and 3 has affects on temperature in animals and has 4 been used for testing dopaminergic responses. 5 Q. How does that relate to 6 Fluoxetine? 7 A. I think it's implicit in the 8 next sentence. 9 Q. Why don't you go ahead and 10 read the next sentence. 11 A. It says that Elavil and 12 Aventryl enhance gnawing but DMI and Tofranil do 13 not and also may have effect on temperature. And 14 what the effects are, I think, I wouldn't swear 15 to it, but I think it tended to reduce 16 temperature in compounds which antagonize, this 17 might be effected to antagonize and so on. 18 Q. What are Elavil and Aventyl? 19 A. Elavil is an American 20 antidepressant which was marketed in 1962 just 21 before the Kefauver investigation, and Aventyl -- 22 and this is called Amytryptiline AMI, and Aventyl 23 is Nortriptyline which Doctor Mills and I 24 developed and is marketed by Eli Lilly and Page 134 1 Company about 1964. There was a delay between 2 the Elavil and the Aventyl was the period of the 3 Kefauver investigations when FDA wasn't approving 4 anything. But Nortriptyline is an excellent 5 antidepressant, I'm proud of it. 6 Q. What is substantial or 7 enhanced, is that -- 8 A. What? 9 Q. It says Elavil and Aventyl, is 10 that enhanced or -- 11 A. Enhanced. 12 Q. Enhanced gnawing? 13 A. Gnawing behavior, in the 14 animals. 15 Q. Oh, the animals began to chew 16 and gnaw on their cage or something? 17 A. Yes. This I think is a model 18 that some people think is related to vomiting but 19 I think, I don't know whether mice vomit, I know 20 rats don't. 21 Q. It says Stark felt that the 22 discussion was useful but Molloy was depressed. 23 Is that what that says? 24 A. Uh-huh. Page 135 1 Q. The idea of setting patterns 2 and then trying to select -- what is that? 3 A. Unique. 4 Q. Unique. 5 A. Compounds, C-P-D-S. 6 Q. Compounds for clinic? 7 A. Yes for clinical trials, for 8 the clinic, I left a word out, you'll see that in 9 many places, I leave words out. 10 Q. For clinic seems fruitless to 11 me unless clinicians are more? 12 A. Enthusiastic about blue sky 13 experiments. 14 Q. What is a blue sky experiment? 15 A. Wishful thinking. 16 Q. What do you mean here when you 17 say the idea of setting patterns and then trying 18 to select unique compounds for the clinic seems 19 fruitless to me unless clinicians are more 20 enthusiastic about blue sky experiments? 21 A. I thought that if the only 22 sign of activity that you had was that you had a 23 strange interaction with drugs, it would be hard 24 to interest the clinicians in putting such drugs Page 136 1 in people without a lot of ancillary data. 2 Q. All right. And does this 3 notation on page 2 go with and follow along with 4 the notation on page 1? 5 A. Yes. 6 Q. All right. How do they 7 relate? 8 A. Well, the suggestion was made 9 at the meeting that we should check the effect of 10 Apomorphine and how it was influenced by 11 pretreating the animals with a new compound and 12 setting patterns of any thought, that was 13 unlikely to get us anywhere. 14 Q. How did that relate to 15 Fluoxetine? 16 A. It shows that this was one of 17 the many times when I was wrong. 18 Q. But the discussion, did it 19 have anything to do with Fluoxetine? 20 A. No, this was the beginning of 21 the screen that ultimately developed compounds 22 that -- and finally Fluoxetine. 23 Q. All right. Now turn with me 24 to page 3, your notation of 3-14-72. It says Page 137 1 Molloy, and then I can't read the rest. 2 A. Summarize current data on 3 94939 -- and that is a chemical structure. I do 4 believe that we'll have an effective 5 antidepressant with a low level of side effects 6 at odds of about one in five, there have been so 7 many failures here. 8 Q. What's the compound 94939? 9 A. It unitmately became 10 Nisoxetine. 11 Q. Is that a specific serotonin 12 reuptake inhibitor? 13 A. No. 14 Q. Was it an anti -- was it being 15 investigated for antidepressant properties? 16 A. It was an effective 17 antidepressant, I think, there wasn't enough 18 clinical data to be sure. 19 Q. You said it would have a low 20 level of side effects and then you put in 21 parentheses, they're at odds of one slash five? 22 A. Uh-huh. 23 Q. Did you mean one side effect 24 for every fifty-seven patients that were being Page 138 1 treated? 2 A. No, I meant some compounds had 3 been introduced in the clinic as possible 4 antidepressants and some had fallen by the 5 wayside, around the industry that nobody could 6 put a compound in the clinic with anything more 7 than a hope of one in five it would be an 8 effective drug. 9 Q. When you say there have been 10 so many failures here, you're talking about the 11 poor -- 12 A. Response rate. 13 Q. -- response rate in getting a 14 new antidepressant marketed or effected, I guess 15 is the term? 16 A. Yes. 17 Q. How does this relate to 18 Fluoxetine and Prozac? 19 A. Nisoxetine comes from the same 20 chemical series and differs from Fluoxetine in 21 the vega methoxy group in the two positions on 22 the phenyl nucleus where Fluoxetine has a true 23 phenyl methyl group, so chemically they're 24 closely related, pharmacologically they're Page 139 1 entirely different. 2 Q. In what respect? 3 A. Fluoxetine is a unique 4 serotonin reuptake inhibitor. 5 Q. On page 4, you have got a 6 9-16-72 notation saying our first BP experiments 7 with 94939 has shown an increase in BP and a 8 contraction of a mictating membrane after zero 9 point three and one point zero milligrams per 10 kilo I.V., will try reserpinizing cat today. 11 A. A cat treated with reserpine. 12 Q. And again 94939 is not 13 Fluoxetine but is an agent similar? 14 A. Chemically. 15 Q. How does this notation have to 16 do with Fluoxetine or Prozac? 17 A. Only in the fact that it was a 18 step toward it, the fact that it was an 19 antidepressant and it was in the same chemical 20 class. 21 Q. I think I asked you this but I 22 have forgotten what your answer was, is 23 Nisoxetine a specific serotonin reuptake 24 inhibitor? Page 140 1 A. No, it is not. 2 Q. It is not? 3 A. No. 4 Q. And the next notation is 5 10-19-72 and what does that say, Doctor? 6 A. It says I presented a summary 7 of data on 94939 to the CNS committee on 10-17 8 and to Doctor -- to Herr's staff today. Will 9 recommend clinical trial, remembering Gershon's 10 many failures. I'm now betting two to one 11 against but hope for the best. If the compound 12 is an antidepressant it should have fewer side 13 effects. 14 Q. Were there any clinical trials 15 done on 94939? 16 A. Yes. 17 Q. Were any clinical trials 18 completed that you know of? 19 A. Completed? 20 Q. Yes. 21 A. They stopped. I don't know if 22 it says -- if I wrote it down why the compound 23 was effective as an antidepressant, but its one 24 patient may or may not have shown a decrease in Page 141 1 white blood cells, this has been a matter of 2 dispute for many years and nobody really knows 3 but it was decided not to continue. 4 Q. And 94939 was never marketed? 5 A. No. 6 Q. There's the next notation on 7 page 6, February 2, '73, it says left pen at 8 home. 9 A. Yes, this is in a different 10 pen, yes. 11 Q. Yesterday I began a campaign 12 to get 82816, our specific 5 HT uptake inhibitor 13 into the clinic soon, nobody seemed ready to risk -- 14 A. Rush. 15 Q. Rush (i.e. Fuller, Molloy or 16 Stark), I think our present data are sufficient 17 for a go decision. And I can't read what the 18 next word is. 19 A. No additional negative result 20 will negate decision but a large body of 21 additional data will be collected. 22 Q. All right. And compound 82816 23 is what, Doctor? 24 A. It's the oxalate salt and Page 142 1 Fluoxetine is a Hydrochloride. 2 Q. And the fluoxetine oxalate 3 salt and Fluoxetine Hydrochloride are both 4 chemically and physiologically Fluoxetine? 5 A. Yes, but you can't give 6 oxalate salt to people. 7 Q. Why is that? 8 A. I think oxalate is a toxic 9 substance so it was clear that we would have to 10 use a different salt. 11 Q. But 82816 is the new drug that 12 became Fluoxetine, is that right? 13 A. Yes, in a sense. 14 Q. And there you say, I think our 15 present data are sufficient for a go decision. 16 No additional negative result will negate the 17 significance but a -- is that large body of 18 additional data will be collected? 19 A. Uh-huh. 20 Q. What do you mean there when 21 you say no additional negative data will negate 22 the decision? 23 A. I meant data that showed a 24 lack of activity in any additional tests. Page 143 1 Q. So there wouldn't be anything -- 2 I'm still not understanding. 3 A. Clearly any toxic data would 4 cause the compound to be set aside but negative 5 data which implied that it was a remarkable 6 psychiatric drug in animals would change my 7 feeling that we probably had an antidepressant. 8 Q. Can we say there by virtue of 9 your notations there that in February of 1973 you 10 became convinced that Fluoxetine Hydrochloride 11 would be an effective antidepressant? 12 A. No. I think we can say that I 13 was convinced that it was a compound worthy of 14 being tested as a possible antidepressant which 15 is a little different. 16 Q. There's a notation looks like 17 written sideways under the date 2-2-73. 18 A. This is Fluoxetine oxalate. 19 Q. And what's -- what are the 20 numbers on top of that? 21 A. That's the day I made the 22 note. 23 Q. Okay. I can't read those 24 numbers, it's a poor xerox. Page 144 1 A. I think it says 7-13-84. You 2 want to know what this is about? 3 Q. Sure. 4 A. Well, you ask me questions. 5 Q. I'm just wondering, did you 6 have some occasion in 1984 to go back and review 7 your notes? 8 A. I was curious to see how long 9 it had been between the time I had made the 10 decision to go and the compound was beginning to 11 be likely to be marketed and it shows eleven 12 years of study which impressed me as a long time. 13 Q. That was '84 and actually 14 Prozac didn't come on the market until December 15 of '87 so it was going to be an additional three 16 years before. 17 A. I think this was about the 18 time that they were beginning talking about 19 submitting the data to the FDA. 20 Q. You had retired from Lilly? 21 A. Yes. 22 Q. And retired December 31st, 23 '79. Were you keeping in touch with the 24 scientist at Lilly? What was it that made you go Page 145 1 back and make this notation then? 2 A. I don't remember. 3 Q. The next notation on page 7 is 4 indicated 4-10-73, can you read that for us? 5 A. It says 82816 (110140) reduced 6 REM sleep in five of six cats, the sixth had 7 almost none to start, doses of two and a half to 8 five milligram, reserpine increases PGO spikes. 9 Q. What are PGO spikes? 10 A. I think pontogeniculate, if I 11 remember. I used to be an expert in the sleep 12 business but that was a long time ago. 13 Q. A PGO spike is something you 14 see? 15 A. It's an 16 electroencephalographic wave with a sharp margin, 17 a sharp pattern. 18 Q. Here where you're talking 19 about the REM sleep in the five or six cats, is 20 this the same experiment that is the subject of 21 your article? 22 A. Yes, this is the beginning. 23 Q. Turn to page eight, and can 24 you read me that notation, 6-11-73? Page 146 1 A. Parachloramphetamine causes 2 long lasting, two to three month, decrease in 3 brain serotonin level. 4 Q. What is parachloramphetamine? 5 I didn't say that right. 6 A. Parachloramphetamine is an 7 amphetamine with the chlorine molecule in the 8 imperial position and it is a substance which 9 decreases brain serotonin levels. It's not a 10 marketed drug, I don't think. It might be an 11 appetite suppressant but I don't know if it is. 12 Q. Were you using this? 13 A. Doctor Fuller was using this 14 as a tool. 15 Q. All right. Go ahead and read 16 the rest of it. 17 A. When 110140 is administered 18 three, six, twenty-four or forty-eight hours 19 after parachloramphetamine, the 5 HT decrease is 20 reversed, but Fluoxetine at seven days does not 21 alter the decrease when rats were killed on day 22 eight. Could there be a lack of binding sites 23 and would 5 HT still be down at day nine and ten 24 and so on. Fuller may look into this. The major Page 147 1 idea here is Ray's, which is Doctor Fuller, I 2 suggested a two or three day wait. 3 Q. All right. Doctor, since I'm 4 not a doctor or a chemist or scientist, can you 5 explain to me what we're talking about in this 6 notation of June 11th, 1973? I need your help in 7 telling me what you're discussing. 8 A. Since it's fifteen years, I 9 probably need Doctor Fuller's help, but this is 10 related to the mechanics of serotonin uptake and 11 the fact that parachloramphetamine is presumably 12 using the same mechanism or affecting the 13 serotonin levels in the brain and determining 14 what the consquences of affecting serotonin 15 uptake. 16 Q. So what does this mean by when 17 you administer Fluoxetine after this 18 parachloramphetamine, the decrease in serotonin 19 is reversed? 20 A. I'm not sure anymore. I'm 21 sorry, I can't -- I used to know. 22 Q. Do you have a general sense of 23 what the significance of this notation was? 24 A. The significance is that the Page 148 1 compound works not only in isolated systems, such 2 as Doctor Wong had done, but seems to work in 3 intact animals. 4 Q. And was producing a measurable 5 decrease in the serotonin level in rats in this 6 instance? 7 A. Well, it says an increase 8 because the decrease was reversed. 9 Q. Okay, all right. 10 A. So this was one of many 11 experiments that were designed to examine the 12 effects of Fluoxetine on brain chemistry. 13 Q. Do you recall why it was that 14 you happened to make this note concerning this 15 particular -- 16 A. No. 17 Q. -- experiment? 18 A. No, I don't remember the 19 details. 20 Q. It apparently seemed 21 noteworthy to you at least at the time because 22 you did make a notation. 23 A. It seems to me that here we 24 have some more data that this is a Page 149 1 physiologically active substance. 2 Q. Fluoxetine? 3 A. Yes. 4 Q. Now, under that is a note, 5 6-12-73, Molloy and Fuller want to see whether we 6 can develop a central 5 HT blocker using the 7 sleep induced -- is that induced? 8 A. Induced. 9 Q. In six day old chicks by I.V. 10 injection, I tried Epinephrine? 11 A. Yes. 12 Q. In one chick and it is not 13 very hard. It's not very hard to -- 14 A. It is not very hard to 15 evaluate. 16 Q. Evaluate. Is this the chick 17 study that you were talking about earlier? 18 A. Yes. 19 Q. And is this further evidence 20 of your judgment? 21 A. Probably. 22 Q. That Fluoxetine has a 23 physiological effect on brain chemistry? 24 A. Yes, uh-huh. This was the Page 150 1 first talk about it but this is not the 2 experiment. 3 Q. And is the notation on page 4 nine of 6-25-73 a follow-up on that? 5 A. Uh-huh. 6 Q. This is the second run using 7 five milligram? 8 A. A kilogram of 5 HT did give 9 something that looked like sleep and was 10 different from control. 11 Q. Go ahead. 12 A. One milligram plus 110140 gave 13 sleep equal to five of 5 HT. In other words the 14 block of serotonin reuptake seemed to enhance the 15 effect of the serotonin. And then 55857 and 16 methysergide did not antagonize ten milligram per 17 kilogram. These are two serotonin blocking 18 agents. 19 Q. All right. Your notation of 20 10-11-73 has to do with 94939 and so does your 21 12-14-73 notation. Then on page twelve, you note 22 on 1-18-74 that increasingly I am concerned about 23 urinary retention with 110140. Is that Dick 24 Moore? Page 151 1 A. Uh-huh. 2 Q. First noticed that our 3 twenty-four hour cats often failed to urinate 4 over night. Tust report that one new dog 5 collected two hundred fifteen milliliters in her 6 bladder. Molloy suggested that -- 7 A. Tust. 8 Q. Tust check this in rats. The 9 last five hour run does not suggest retention. 10 And I can't read that last sentence. 11 A. We may have to do cystograms. 12 Q. Did you ever determine whether 13 or not Fluoxetine caused urinary retention in 14 animals or humans? 15 A. I never did in humans and we 16 had the data from the cats which are described 17 here and we didn't see it in rats. 18 Q. But it was demonstrated in 19 cats? 20 A. Yes. 21 Q. 8-21, I suppose that's '73, is 22 that right, or it could be '74. No, it had to be 23 '74, wouldn't it? 24 A. Yes, I would think so, but Page 152 1 that's a long time, isn't it? 2 Q. You mentioned 21094 was 3 thought to be a very active inhibitor of 5 HT 4 uptake with less specificity than 110140. What 5 was 21094? 6 A. Well, it says here it turns 7 out that the original sample came from a 8 mislabeled bottle and was a Dupont compound with 9 a fused eight membrane, that the clinical trial 10 of that compound by Doctor Gershon showed it to 11 be inactive as an antidepressant. 12 Q. It does not have amphetamine 13 like activity. What does it mean in relation to 14 Fluoxetine, to 110140, did it have any relation 15 to Fluoxetine? 16 A. No it's a wholly different -- 17 the question was would a compound, the Dupont 18 compound which was an inhibitor of serotonin 19 uptake and of other things, but it was less 20 specificity, it turned out clinically not to be 21 an active antidepressant. These are one of the 22 many failures of which I mentioned. 23 Q. Does Fluoxetine have 24 amphetamine like activity? Page 153 1 A. No, I don't think so. It 2 depends on how you define amphetamine activity. 3 But I can't say, the only one, people eat less 4 after amphetamine and many people eat less after 5 Fluoxetine. 6 Q. Amphetamines are generally 7 stimulants also, aren't they, Doctor? 8 A. Amphetamine is a stimulant. 9 Q. And Fluoxetine acts as a 10 stimulant in many individuals, does it not? 11 A. I don't think so but I really 12 don't know. 13 Q. Well, it had a stimulating 14 effect on the cats, didn't it? 15 A. It made the cats somewhat 16 irritable, it may have been the distended bladder 17 for all I know. 18 Q. Turn to page nineteen with me, 19 Doctor, to your notation of 1-16-76. There's 20 talk there about compound 99638 and 94939. What 21 is the relationship of these notations and these 22 compounds to Fluoxetine? 23 A. Oh, the relationship of the 24 first paragraph is none. The relevant Page 154 1 information is, talked with Bennett, Fuller, 2 Molloy and Rathbun yesterday about J. Small's 3 study of ten patients on 94939. We were all 4 puzzled by the high incidence of tremor, our 5 question is whether some were extra-pyramidal 6 reaction, both Bennett and Lemberger have lined 7 up possible investigators, it looks like two 8 thousand patients for four weeks. One patient, 9 an obsessive-compulsive, showed really remarkable 10 improvement but all the patients were drug 11 refractory. The first paragraph is about some 12 antibiotic research which has nothing to do with 13 that and the second paragraph is related to 14 Nisoxetine, we included all the Nisoxetine data 15 just for the sake of completion, to be complete 16 with what we gave you, although it really is not 17 directly related to the questions you're asking. 18 Q. Who is Bennett? 19 A. Irvin Bennett is a 20 psychiatrist hired by Eli Lilly and Company. I 21 think he died last year. 22 Q. And he was employed at Eli 23 Lilly and Company? 24 A. Yes. Page 155 1 Q. What's the notation on page 2 twenty, dated 6-16-76, have to do with 3 Fluoxetine? 4 A. The 94939 Nisoxetine study. 5 Q. The last says, I don't think 6 very much good is going to come out of all this. 7 A. These were some very esoteric 8 studies that somebody wanted to do in Chicago 9 about behavioral changes with these two 10 behaviorally active drugs, Nisoxetine and the 11 109514, and they were going to do some aberrant 12 behavior experiments, I don't remember what the 13 details were, and they wanted fifty-six thousand 14 dollars to do these studies and my impression was 15 that we would just be throwing money away because 16 they weren't going to ask any questions about the 17 antidepressant properties of Nisoxetine. I don't 18 think the studies were funded. 19 Q. Read the 9-8-76 notation on 20 page twenty-one? 21 A. Twenty-one? 22 Q. Yes. 23 A. Talked with Marsden and 24 Kiplinger about Bennett, 94939 and report forms. Page 156 1 The current delay results from preparation of 2 forms which is essential for starting. This I do 3 not understand. Talked with Fuller to say that 4 if Lemberger is not interested in acting as 5 monitor on 110140 then he, Molloy or I will have 6 to take over. We had become discouraged with the 7 pace that Doctor Bennett was able to generate. 8 Q. All right. You and Molloy and 9 Lemberger? 10 A. Uh-huh. 11 Q. And Fuller were discouraged 12 with the pace that Doctor Bennett, the 13 psychiatrist, was moving? 14 A. On the 94939. 15 Q. But you mentioned 110140, 16 Fluoxetine, also? 17 A. We were about at the stage 18 where we were beginning to think about the 19 clinical trial of this compound and Doctor 20 Bennett had additional responsibilities. It was 21 our judgment that the research would not move 22 forward at a reasonable pace under Doctor 23 Bennett's supervision. 24 A. All right. Did Doctor Bennett Page 157 1 ever participate -- 2 A. Not to my knowledge. 3 Q. -- in any clinical trials on 4 Fluoxetine? 5 A. Not to my knowledge. 6 Q. Was Doctor -- 7 A. Doctor Shulman. 8 Q. -- Doctor Shulman the first 9 physician to participate in the clinical trials? 10 A. Yes -- well, Doctor Lemberger 11 did the Phase 1 studies. 12 Q. But the first clinical trials 13 on humans were done by Doctor Shulman? 14 A. Well, Phase 1 studies are 15 clinical trials. 16 Q. Okay. But they're not 17 depression, the patients are not depressed? 18 A. Right. 19 Q. All right. Who is Kiplinger? 20 A. Kiplinger is a physician who 21 was at the Lilly clinic at one time and another 22 time was in Greenfield, the site where we did 23 toxicity studies, and I'm not sure now which job, 24 again which job Glenn had at this time, okay. Page 158 1 Q. All right. 2 A. So -- 3 Q. Did you talk with anybody else 4 other than Doctor Fuller concerning you're 5 disappointed with Doctor Bennett and his 6 performance in the clinical trials on these other 7 compounds? 8 A. I don't remember. 9 Q. Who would have been your 10 supervisor or the person -- 11 A. Who? 12 Q. -- who would have been your 13 supervisor, the person to whom you reported in 14 September of 1976? 15 A. Probably Irvin Johnson. 16 Q. Do you have any recollection 17 of any discussions with Doctor Johnson concerning -- 18 A. No. 19 Q. -- Doctor Bennett not 20 participating in the Fluoxetine clinical trials? 21 A. No. 22 Q. Read for me, please, the 23 notation on page twenty-two of 2-14-77. 24 A. At the moment our cats look Page 159 1 not to hot, attempts to block 110140 REM 2 suppression with either methysergide or 3 cyproheptadine did not work. These are two 4 serotonin blocking agents. The methysergide cats 5 became sick and vomited, the cyproheptadine cats 6 were hyperactive. What does this mean. 7 Q. Okay. What does it mean? 8 A. I didn't know then, I don't 9 know now. 10 Q. Still a mystery? 11 A. Yes. 12 Q. As to why you were having the 13 bad results with these cats? 14 A. Say that again. 15 Q. It's still a mystery as to why 16 you were having the bad results with these cats? 17 A. These were not bad results, 18 these were the cats. It's a mystery why the cats 19 became hyperactive after the cyproheptadine. 20 Q. Next notation is 4-13-77, it 21 says Ivan Bennett visited, and then something is 22 blacked out. 23 A. It's the name of an 24 investigator. Page 160 1 Q. Okay. 2 A. Who was, as I understand it, 3 not pivotal. 4 Q. All right. You understand 5 since we have had lunch and you talked to your 6 lawyers the difference between a pivotal and 7 nonpivotal investigator? 8 A. No, do you? 9 Q. I don't think anybody does, 10 Doctor Slater, certainly nobody here in this 11 room. Larry Myers claims to, maybe. Nancy 12 Zettler on this side. I'm sorry for that off 13 comment. Would you continue reading what that 14 notation is, it says Ivan Bennett visited some 15 investigator? 16 A. Who gave us patients with 17 obsessive-compulsive for 494939. 18 Q. What -- I can't read. 19 A. It's really bad English, isn't 20 it, I should be ashamed of myself. I think what 21 the inference is this man had available two 22 patients with obsessive-compulsion that would be 23 candidates for taking 94939. 24 Q. Okay. But it's the middle Page 161 1 sentence there that I can't read, Ivan Bennett 2 visited, blanked out, and then it says in, and I 3 can't read that next word. 4 A. In Manhasset. 5 Q. Manhasset? 6 A. Yes. 7 Q. Oh, that's the name, 8 Manhasset, Long Island? 9 A. Right. We say Long Guy Land. 10 Q. On Fuller's urging? 11 A. Yes. 12 Q. And you're either getting 13 tired or you're changing pens because I'm having 14 difficulty reading your writing on page 24 of 15 5-13-77. Can you read that for me, Doctor? 16 A. This was -- this says each 17 time the telephone rings I wonder if Besch is 18 calling. I must be very interested. I have a 19 tentative list of when and in what order I would 20 tell people. What this is is it has nothing to 21 do with anything here. I was thinking of 22 retiring and I had been discussing with Doctor 23 Besch, who is chairman of the pharmacology 24 department at the main hospital, Indianapolis Page 162 1 Campus of the medical school, and they were 2 considering appointing a new professor of 3 pharmacology for the Bloomington campus and 4 Doctor Besch was wondering if I might be 5 interested and I didn't know whether I was or 6 wasn't but this says I must really be interested 7 and then the job was given to somebody else so 8 nothing came of that. But now I'm going to 9 finish the paper on 110140, which I think is 10 probably this one. 11 Q. What we have marked as Exhibit 12 1 -- 13 A. Uh-huh. 14 Q. -- what we have marked as 15 Exhibit 1 -- 16 MR. ARMSTRONG: This paper right here. 17 A. Okay, fine. 18 MR. ARMSTRONG: This is 2. 19 A. This is 2. 20 Q. It looks like 10-10-78 is when 21 you were first approached concerning the 22 Fluoxetine clinical trials. 23 A. Doctor Fuller apparently asked 24 me, I don't remember this conversation but here Page 163 1 it is. 2 Q. It says, Ray Fuller asked when 3 I would be willing to take over the clinical 4 monitorship of Fluoxetine when Bob Shulman 5 leaves, I said that I would not volunteer but if 6 asked I would. Correct? 7 A. Correct. 8 Q. Apparently in October of '78, 9 it was already known that Bob Shulman was 10 leaving? 11 A. Yes. 12 Q. Does that refresh your 13 recollection? You said earlier this morning that 14 you weren't sure whether he was fired or whether 15 he quit or what happened to him. 16 A. No, I just know he left. I 17 was never privy to the decisions a person held in 18 the medical department. They didn't discuss this 19 with me. 20 Q. How long was Doctor Shulman 21 with Lilly? 22 A. Perhaps as long as a year but 23 I don't think as long as two years. Doctor 24 Shulman is a wandering man, he had many jobs. Page 164 1 Q. And he left Lilly and went to 2 San Antonio, did you say? 3 A. Uh-huh. 4 Q. Was that a yes? 5 A. Yes. 6 Q. Can you read the notation of 7 10-26-78? 8 A. If 5-HT agonist effects 9 contribute to LSD induced limb flicks, would 10 Fluoxetine enhance flicks or reduce dose. 11 Q. All right, what are LSD 12 induced limb flicks? 13 A. A guy at Princeton whose name, 14 he's Barry somebody, published a paper in Brain 15 Research which said that cats treated with 16 relatively large doses of LSD-25 developed a 17 peculiar pattern of flicking their paws and he 18 attributed that to a synergic mechanism and I was 19 wondering if indeed this was a synergic 20 mechanism, how would Fluoxetine affect it. I 21 don't think we ever did the experiment. 22 Q. You didn't notice this LSD 23 flick in the cats that you administered 24 Fluoxetine to? Page 165 1 A. No. We did a fairly long 2 series of studies on limb flicks because we were 3 looking at pergolide at the time. 4 Q. At what? 5 A. Pergolide, which is a drug 6 used for treatment of Parkinsonism but I don't 7 think it's worthwhile going into these and I 8 don't agree with Doctor whatever his name was, 9 Barry something, that this is a specific test for 10 anything. 11 Q. Is it your testimony that LSD, 12 its psychotropic effect is on the serotonin 13 system? 14 A. Not mine. That's out there, 15 there's some -- LSD effects in this particular 16 assay occur at doses that are larger in 17 milligrams per kilo in cats than the doses, total 18 doses given to man, and produce all the 19 hallucinations, man will have hallucinations with 20 a fraction of a milligram of LSD, and it takes at 21 least that much milligram per kilo in a cat to 22 induce limb flicks and you can induce limb flicks 23 in cats with a large variety of alkaloids at 24 comparable doses and these compounds are in Page 166 1 clinical use all the time for a variety of things 2 like treating postpartum hemorrhage, treating 3 migraine and so on, and do not at modest doses 4 cause hallucinations. There's no question that 5 there are a lot of drugs that in very large doses 6 will cause hallucination. 7 Q. We're speaking of LSD or when 8 you're speaking of LSD are you using that term 9 like we pick up a Time Magazine? 10 A. Yes. 11 Q. So a resurgence of LSD, I 12 wouldn't -- is the effect, the hallucinatory 13 effect that LSD is having on me, is that 14 affecting my serotonin system in my brain or is 15 it affecting my dopamine system? 16 A. I really don't know, it's 17 occurring at such small doses it's very hard to 18 be sure. 19 Q. At large doses it's affecting 20 the serotonin system in cats, you know that. 21 A. Yes. 22 MR. SMITH: Let's take a break. 23 (A SHORT BREAK WAS TAKEN.) 24 Q. Doctor, I'm sorry to continue Page 167 1 it to this, but we need to get what you stated 2 here and make sure we're clear. Let's go to page 3 twenty-seven, your notation of November 30th, 4 1978. This is your -- it says this is our 5 conversation about the needs for a C.V. group was 6 interrupted by a call from Shedden and then by an 7 8 a.m. appointment. When you say C.V. group -- 8 A. Cardiovascular. 9 Q. -- continuing, I have a note 10 saying that he'll be back in touch with me later 11 the a.m. I wonder -- then is there something 12 marked out there? It says I wonder and then it's 13 blank by that. 14 A. No, I think that's the way it 15 reads and then the next paragraph, returned to my 16 office not to discuss cardiovascular situation 17 but to say that Shedden would like me to take 18 over the monitorship of Fluoxetine. We called 19 Shedden and agreed to do so. 20 Q. When you say he returned to my 21 office not to discuss C.V. situation but to say 22 that Shedden would like me to take over the 23 monitorship of Fluoxetine, who is he? 24 A. I haven't the faintest idea. Page 168 1 I really had a recollection of having been in 2 Doctor Shedden's office to discuss this and this 3 doesn't jive with my recollection so -- 4 Q. You then say, then called Nick 5 and Johnson in San Diego so that they could talk 6 with -- then it's blanked out -- about a clinical 7 trial of Fluoxetine for pain. Correct? 8 A. Yes, and Nick is Doctor Nick 9 Ander who was in charge of analgesic testing. 10 Q. All right. 11 A. And he and Doctor Johnson were 12 in San Diego. 13 Q. Doctor John Feighner is in, 14 Doctor Feighner and the Feighner Research 15 Institute is in San Diego? 16 A. I don't know anything about 17 them. 18 Q. Is the fellow that's marked 19 out, Doctor Feighner's name? 20 A. No. 21 Q. You don't know Doctor John 22 Feighner in San Diego? 23 A. No, all I know about him is 24 that he talks with Doctor Stark, that's Page 169 1 everything I know about him. 2 Q. He had done some clinical 3 trials for Lilly in connection with Fluoxetine 4 but they may have been done after you left? 5 A. Oh, yes. 6 Q. Now the 12-13-78 note looks to 7 me like it might be something to do with some 8 personal matters. 9 A. Yes. 10 MR. ARMSTRONG: I overlooked that. 11 THE WITNESS: You slipped up, Jim. 12 MR. ARMSTRONG: Yes, sure did. 13 Q. The next notation I see is 14 12-21-78, it says as monitor I have sent a 15 protocol to an investigator that's been marked 16 out. Purpose -- is that purpose? 17 A. Prepare. 18 Q. Prepare one on analgesia for -- 19 and then there's another investigator marked out, 20 and says and will start on Noble. 21 A. Yes. 22 Q. Who is Noble? 23 A. Noble, is he listed among the 24 key people? Page 170 1 MS. HUFF: No, should have been 2 extracted. 3 A. He's a man who does clinical 4 testing for antiobesity drugs in San Francisco. 5 Q. He's a fat doctor in San 6 Francisco? 7 A. Yes. 8 Q. That first paragraph there, it 9 says as monitor I have sent a protocol to, and 10 then it's marked out, then the next you say 11 prepared one on analgesia for, and then it's 12 marked out. My question is in connection with 13 that first protocol that you sent to the first 14 investigator, that's marked out there, do you 15 recall whether or not that was a depression 16 protocol or analgesia or obesity or some other 17 type of indication? 18 A. I have to have an unmarked out 19 version. I think it was antidepressant. 20 Q. I think it's significant that 21 we know if it's an antidepressant but if we can 22 show you the unredacted portion to answer that 23 question, I appreciate that. 24 A. Antidepressant. Page 171 1 Q. It says Jim Harley? 2 A. Yes, that has nothing -- Jim 3 Harley was one of the other research people who 4 retired sometime after I did and also moved to 5 Florida. We thought we would be able to see each 6 other but we never did. 7 Q. So would it be accurate to say 8 at the time you began as monitor for the 9 Fluoxetine clinical trials and were doing these 10 protocols that you had already made the decision 11 to move to Naples, Florida? 12 A. Yes. My 62nd birthday was 13 September 11th, 1979, after which I would get a 14 no deduction from my pension rights and it seemed 15 an appropriate time to retire. 16 Q. All right. Go ahead and read 17 the 12-22 notation. 18 A. 12-22? 19 Q. Yes, under the 12-21, it looks 20 like there's a 12-22 notation. 21 A. Managed to get protocol 22 proposals to both, blank, and Bendush thinks 23 Fluoxetine is part way down the tube and doesn't 24 want to spend four thousand five hundred Page 172 1 ninety-eight dollars for one patient with 2 narcolepsy. 3 Q. And who was Bendush at this 4 time? 5 A. Bendush was the man between me 6 and Doctor Shedden, he was in charge of medical 7 affairs. 8 Q. Did you and -- you and Doctor 9 Bendush ever discuss why he felt that Fluoxetine 10 was part way down the tube at that time? 11 A. This was his judgment based on 12 Doctor Shulman's recommendation. 13 Q. Do you know if a Doctor 14 Shulman ever wrote a formal memorandum or report 15 formally recommending that the clinical trials on 16 Fluoxetine be abandoned? 17 A. I do not. 18 Q. All right. There's a notation 19 on page 31 dated 1-29-79, correct, is that right? 20 A. Uh-huh. 21 Q. The next notation is 1-29-79? 22 A. Yes. 23 Q. Can you read that, please? 24 A. I returned from a trip to the Page 173 1 West Coast and Houston to set up trials of 2 Fluoxetine. Is willing to start obesity testing 3 right away but that will have to wait until we 4 have more out-patient data. 5 Q. Let me ask you this before you 6 continue, you talked about dog protocols on -- 7 potential dog protocols on analgesia and studies 8 in connection with obesity. And of course there 9 was the main issue I would assume is whether or 10 not Fluoxetine would be effective or efficacious 11 in treating depressed patients, is that right? 12 A. Yes. 13 Q. You also mentioned narcolepsy. 14 Were there investigations ongoing at that time of 15 Fluoxetine for other uses even though the medical 16 monitor who had preceded you had felt that 17 Fluoxetine was not efficacious in treatment of 18 depression? 19 A. There are a lot of ideas 20 flitting around people's mind. Doctor Fuller has 21 always thought that Fluoxetine should be an 22 effective antiobesity agent based on a lot of 23 animal data, has always been curious to know 24 whether that would be a worthwhile indication. Page 174 1 There was a man on the West Coast, who's name 2 that we have deleted because there was really no 3 point of his becoming involved, who had an idea 4 about the role of serotonin and pain, and he had 5 talked about this when Doctor Nick Cander and 6 Doctor Johnson were on the West Coast and were 7 trying to promote a grant from us to do this. 8 But what I was assigned or committed to do was to 9 see whether we had a compound that was worthy of 10 further testing as an antidepressant and to a 11 large measure I was able to fulfill this role. 12 There was one patient on the West Coast who had a 13 muscularum deformans, which is a very strange 14 disease, whose neurologist had treated her with 15 Fluoxetine and she had a remarkable improvement 16 and this patient stayed on Fluoxetine for months 17 and finally the FDA wrote to us and told us this 18 was ridiculous so we stopped it and we got a 19 pitiful letter from her husband saying since she 20 had stopped the medication she was in a terrible 21 state, couldn't we do something. So her 22 neurologist, we made a special petition to the 23 FDA and they put her back on the drug. She 24 stayed on the drug longer than any toxicity Page 175 1 studies, we watched her carefully and took many 2 tests and the physician thought the benefit was 3 worth the risk. 4 Q. What was the disease? 5 A. Muscularum deformans. 6 Q. And how does that manifest 7 itself? 8 A. Like that, (INDICATING), 9 squirming, endless squirming and random, meaning 10 difficulty in performing any muscular function. 11 I was puzzled with that, I mean as puzzled as you 12 are. 13 Q. You're puzzled that it was 14 effective in treating this lady? 15 A. Yes, I don't understand why. 16 Q. Her doctor believed that it 17 was beneficial to her? 18 A. Yes, and her husband thought 19 so too. I never saw the woman. 20 Q. And Lilly supported the doctor 21 and the husband's request that the medication be 22 continued, correct? 23 A. Uh-huh. It seemed the humane 24 thing to do, it seemed the humane thing to do Page 176 1 under the circumstances. 2 Q. The fact is that there wasn't 3 any true scientific evidence that the medication 4 would be efficacious for treating the disease, 5 isn't that correct? 6 A. Yes. 7 Q. And yet when she was taken off 8 the medication, the disease reappeared or the 9 symptoms reappeared, did they not? 10 A. That's my understanding. 11 Q. I beg your pardon? 12 A. Yes. 13 Q. When she was put back on the 14 medication -- 15 A. She apparently improved. 16 Q. -- she improved? 17 A. Uh-huh. 18 Q. So is there any question in 19 your mind, based as a physician and as a medical 20 monitor on this medicine, that the drug in this 21 particular patient caused her to have this 22 reaction where she was able to control this 23 muscularis? 24 A. We never did double-blind Page 177 1 studies. 2 Q. Beg your pardon? 3 A. We never did a double-blind 4 study. We never gave a placebo to see whether a 5 placebo would help. It's probable, but it's 6 certainly not established. 7 Q. Was it your judgment that a 8 double-blind study would be necessary before you 9 could ever get to a scientific basis for drawing 10 a conclusion that the medication was efficacious 11 in helping this lady? 12 A. That would be my judgment. 13 Q. But you didn't require that a 14 double-blind study be done on this lady before 15 you helped her in getting this medicine again, is 16 that right? 17 A. Yes. 18 Q. I mean there is a reasonable 19 basis in that instance that there was a cause and 20 effect in connection with Fluoxetine in a 21 particular instance without a double-blind 22 placebo controlled study, correct? 23 A. Yes. 24 Q. You don't have to have a Page 178 1 double-blind placebo controlled study to 2 establish in reasonable medical judgment a cause 3 and effect with a particular medication at a 4 particular -- for a particular problem, do you? 5 MR. ARMSTRONG: Are you asking him as 6 an expert or how are you framing it? 7 MR. SMITH: In his judgment as the 8 medical monitor at the time. 9 A. My judgment is that you can 10 never establish efficacy of a given medication 11 without an adequate clinical trial which includes 12 a double-blind study in most cases. In some 13 cases you can't justify it. On a humane basis, 14 in some cases you can't justify doing the 15 double-blind study. 16 Q. None of the studies that you 17 proposed in order to determine whether or not to 18 continue clinical trials on Prozac were 19 double-blind either, were they? 20 A. No, they were open-label 21 studies to see whether there was any possibility 22 that one would be justified in doing double-blind 23 studies. 24 Q. And you came to the conclusion Page 179 1 that you were justified in continuing on based on 2 studies that weren't double-blind placebo 3 controlled, were you, Doctor? 4 A. Right, everything is in steps. 5 Q. Beg your pardon? 6 A. Everything appears in steps, 7 you have to take step one before you take step 8 two, and so on. 9 Q. I think we got diverted to 10 your note of 1-29-79. You talked about that one 11 of the investigators is willing to start obesity 12 testing right away, but that will have to wait 13 until we have more outpatient data, correct? 14 A. Yes. 15 Q. And it says blank wants to run 16 an inpatient study since he feels his, and then 17 it's blank, patients. 18 A. It describes the site of the 19 patients, where they were. 20 Q. All right. Is blank patients 21 with Ham-D of greater than twenty? 22 A. I think that's a Hamilton B, 23 isn't it, is there such a thing in reading these 24 more recently than I? Page 180 1 Q. I don't know of a Ham-B. 2 A. Hamilton. 3 Q. Right, I know of a Ham-D test. 4 There may be a Ham-B as in boy test, but I think 5 we only have to take that in law school, that Ham 6 has to do with B stands for boloney. No, it's 7 Ham-D, Doctor Slater. 8 A. It may be a D even, this is a 9 physician's handwriting. 10 Q. It says Ham-D greater than 11 twenty or too sick to be alone, most do not have 12 a supportive family situation, blank will 13 continue dystonia studies with less lab work on a 14 modest budget. Is that what that says? 15 A. Yes. 16 Q. Blank wants to do ten pilot 17 patient studies, is that what that says? 18 A. Uh-huh, for pain. 19 Q. For pain. I think we may get 20 real data, but I'm not -- what is that next word? 21 A. Certain. 22 Q. Certain. Why did Cibor-Geigy 23 turn off the -- what is that, CMI study? 24 A. Yes. Page 181 1 Q. What is CMI? 2 A. It's -- I think a 3 chloroamytryptiline, I think. 4 Q. All right. And it says Fabre, 5 he is your new investigator you hired to be in 6 Houston, will do an outpatient pilot, a strange 7 but probably okay setup, is that correct? 8 A. Yes. 9 Q. Why did you say that Doctor 10 Fabre's situation was a strange but probably okay 11 setup? 12 A. Because ordinarily when a 13 physician treats patients, he is paid by the 14 patient for the treatment, but Doctor Fabre 15 treated all his patients without cost, as I 16 remember, and had his income from the people who 17 were sponsoring the trials. 18 Q. Did you know where Doctor 19 Fabre was getting his patients? 20 A. I gathered he was advertising 21 in the newspaper. 22 Q. Did you have any idea who the 23 people were that were responding to those 24 advertisements? Page 182 1 A. I imagined they were people 2 who were depressed. 3 Q. Did you know he was getting 4 his patients from a halfway house for alcoholics? 5 A. No. 6 Q. Would you consider that a 7 strange source to secure patients for a clinical 8 trial, for study of depression by a pivotal 9 investigator? 10 A. Yes, that would be strange, 11 this is not what he told me at the time, I didn't 12 have that impression. 13 Q. What did he tell you at the 14 time? 15 A. He told me that he was getting 16 from advertising in the newspaper and that these 17 were volunteers. 18 Q. But the other investigators 19 that you hired, where were they getting their 20 patients? 21 A. Well, one investigator was in 22 a hospital situation where he had mentally ill 23 patients, and the other was running a clinic for 24 patients with mental problems and was treating Page 183 1 these people, a so-called mental health clinic, I 2 think, is the term we use now. 3 Q. But Doctor Fabre didn't have a 4 mental health clinic so to speak. 5 A. In a sense, that's what I 6 thought he had. 7 Q. Did you see his facility? 8 A. Yes. 9 Q. Did it say Doctor Fabre's 10 mental health clinic on it? 11 A. No. 12 Q. What did it say on it? 13 A. I certainly don't remember, it 14 probably said Doctor something Fabre, I don't 15 remember what his first name was. 16 Q. Was it a normal looking 17 psychiatric office? 18 A. I thought so. Have you been 19 there? 20 Q. No. 21 A. I think he had a separate 22 building and he had a receptionist and he had a 23 couple of treatment rooms and places for keeping 24 records and so on. It looked like a normal Page 184 1 doctor's office to me, as I recall. As I said, 2 it was fifteen years ago. 3 Q. Did you know Doctor Fabre was 4 doing clinical trials on Halcion for Upjohn at 5 the time? 6 A. No. 7 Q. Did he tell you that? 8 MR. ARMSTRONG: I object. If he 9 didn't know, he obviously didn't tell him. 10 A. I don't remember discussing it 11 with him, I think it would have been unethical of 12 him to discuss it with me. 13 Q. I beg your pardon? 14 A. I think it would have been 15 unethical for him to discuss with me a drug trial 16 he was running for another company. 17 Q. Did he tell you that he was 18 doing clinical trials or did you have an 19 awareness that he was doing clinical trials for 20 other companies, for other medications? 21 A. Yes. 22 MR. ARMSTRONG: I object, asked and 23 answered. Go ahead, you can answer. 24 A. I thought that was his Page 185 1 business. 2 Q. Well, was he doing clinical 3 trials? 4 A. Yes. 5 Q. In other words, instead of 6 being a psychiatrist that went out and treated 7 people for various mental disorders, all Doctor 8 Fabre, as you understood it, did was conduct 9 clinical trials for different pharmaceutical 10 companies. 11 A. You can put it that way. You 12 can also say that instead of having private 13 patients who could afford to pay his fees, he was 14 treating relatively less financially secure 15 people and having the drug companies supply the 16 medication and that in general he tried to mix 17 the two activities, he was trying to help people. 18 Q. He was advertising for 19 patients, he told you that. 20 A. Yes. 21 Q. And he didn't have a private 22 practice where any of his patients paid him for 23 an office visit, correct? 24 A. I'm not sure about that. I Page 186 1 know that the patients on whom drugs were being 2 tested were presumably not paying him. 3 Q. Did you ask Doctor Fabre if he 4 had a private practice at all, Doctor Slater? 5 A. I don't remember. 6 Q. Would that have made any 7 difference to you whether or not this particular 8 psychiatrist was maintaining a private practice 9 at all in selecting a clinical investigator for 10 Eli Lilly and Company to do studies on 11 Fluoxetine? 12 A. I don't think so. 13 Q. Why? 14 A. Because I wanted somebody who 15 was interested in testing drugs to see whether 16 they would be effective. 17 Q. Do you remember where you got 18 Doctor Fabre's name? 19 A. Doctor Stark. 20 Q. Did Doctor Stark tell you how 21 he got Doctor Fabre's name? 22 A. No. 23 Q. Did you know whether or not 24 Doctor Fabre had done any other clinical trials Page 187 1 for Eli Lilly and Company? 2 A. He did one for Doctor Stark. 3 Q. Did you know whether that 4 clinical trial had to do with a clinical trial of 5 a psychotropic compound under investigation? 6 A. I wouldn't swear to that, I've 7 forgotten what the trial was about. 8 Q. Was it your understanding it 9 was a psychiatric drug? Doctor Fabre was a 10 psychiatrist. 11 A. Yes, and Doctor Fabre 12 submitted reports and gave reasonable information 13 about the drugs that he was asked to test, this 14 was my understanding. 15 Q. Based on your discussions with 16 Doctor Stark? 17 A. Yes. 18 Q. Did Doctor Fabre leave you 19 with the impression that he secured all of his 20 patients through advertising? 21 A. I sort of had the impression 22 there was some patients referring other patients, 23 but I'm not sure. 24 Q. Do you know whether or not Page 188 1 Doctor Fabre was treating any patients that were 2 not subjects of clinical trials for various 3 pharmaceutical companies? 4 A. No, I don't know. 5 Q. Did you ask him? 6 A. I don't remember. 7 Q. Was it your impression that he 8 didn't have any patients other than patients who 9 were enrolled in clinical trials for various 10 pharmaceutical companies? 11 A. At this late date, it's hard 12 for me to be sure, but I had the impression that 13 there were a few patients who constituted a core 14 stable of candidates, and that some of these 15 patients he was treating on an ongoing basis, 16 perhaps when there weren't any immediate drugs 17 for testing. 18 Q. A core stable, he had a core 19 stable of candidates, is that the term you used? 20 A. That he had some people who 21 came to see him as his patients. 22 Q. But you referred to it as a 23 core stable of patients. 24 A. That's an unfortunate Page 189 1 statement perhaps, but it was a group of people 2 who would be available to him whom he knew and 3 who represented candidates for drug testing. 4 Q. And would this core stable 5 have been the people at the halfway house? 6 MR. ARMSTRONG: I object. You asked 7 him the question, he didn't know the question 8 when you asked him the first time, it's been 9 asked and answered. 10 A. I don't know anything about 11 the halfway house, that's the first I ever heard 12 of it. Does it exist? 13 Q. Yes. Did Doctor Fabre tell 14 you that some of the patients that he was 15 treating with Fluoxetine were going to also be 16 treated with drugs that he was testing for other 17 pharmaceutical houses? 18 MR. ARMSTRONG: Objection, asked and 19 answered. You have beaten this horse to death. 20 Q. If you answered it, I don't 21 remember it, Doctor Slater. 22 MR. ARMSTRONG: I do. You can answer 23 the question again. 24 A. The question maybe is one -- Page 190 1 would you read it to me? 2 (THE COURT REPORTER READ BACK THE 3 REQUESTED TESTIMONY.) 4 A. I would put it the other way, 5 I assumed that these are patients that some of 6 these patients may have been patients he had 7 treated with drugs from other pharmaceutical 8 houses, and that should Fluoxetine be ineffective 9 or completed, that he would refer these patients 10 to other medications, but he didn't specifically 11 tell me that, but that I thought was the nature 12 of his practice. 13 Q. Do you recall what it was that 14 gave you that assumption that he would -- if 15 Fluoxetine would be effective in treating the 16 patient, treat them with another medication? 17 A. Say that again? 18 Q. Do you remember what it was 19 that he either said to you or what it was about 20 his operation that gave you the impression that -- 21 A. We have discussed this about 22 six times. He had a group of patients who he 23 used for testing drugs, and he tested them on 24 Fluoxetine, he had tested them on other drugs Page 191 1 previously, and he would continue, that was his 2 way of practicing. 3 Q. The distinction now in my 4 question is, I need to know if he told you 5 whether or not some of these patients might have 6 been getting Fluoxetine and getting another drug 7 at the same time, in other words he was running a 8 clinical trial on one drug and a clinical trial 9 on Fluoxetine with the same patients at the same 10 time? 11 A. He never told me that, he 12 never told me that he would be treating with more 13 than one medication at a time. 14 Q. You understand the scientific 15 significance of that, don't you, Doctor Slater? 16 A. Yes. 17 Q. All right. Let's go to page 18 thirty-two, the entry of 2-15-79. It's the last 19 two sentences that I'm having difficulty in 20 reading your writing, where it starts I asked 21 about, and I can't read that next word. 22 A. Nabalone and asthma, should I 23 call Lou and talk. 24 Q. All right. Page 192 1 A. Lou Lemberger. 2 Q. Beg your pardon? 3 A. Lou is Lemberger, Doctor 4 Lemberger felt that we couldn't do the studies on 5 analgesics until we had some animal data that 6 confirmed it. 7 Q. Was there ever any animal 8 studies done with respect to the analgesic 9 properties of Fluoxetine? 10 A. I don't remember. 11 Q. Can you read me the notation 12 of 2-21-79? 13 A. Doctor Herr said he was sorry 14 that I have decided to retire, and so on and so 15 forth, mentioned that Step was impressed with my 16 enthusiasm for Fluoxetine. 17 Q. Who was Step? 18 A. Executive vice-president in 19 charge of pharmaceutical marketing. 20 Q. Is Step a first or last name? 21 A. Eugene Step. 22 Q. Continue. 23 A. Johnson says forty-sixty 24 chance on raise which may be about right. I have Page 193 1 now told them that if useful I would carry 2 Fluoxetine on a part-time basis. That is an 3 interesting possibility, at twenty hours per 4 week, that is half time some weeks, full-time, 5 and so on and so forth, it would be very 6 complicated. 7 Q. I don't understand where it 8 says came up at executive committee, what is that 9 next word? 10 A. Oh, that's a long story. 11 Q. What is the word? 12 A. Impromptu. 13 Q. Came up impromptu at executive 14 committee, and what is after that? 15 A. Executive committee meeting. 16 Q. Oh, I thought it was two 17 words, it says Johnson said forty-sixty chance of 18 raise which may be about right. What is that 19 talking about? 20 A. I asked Doctor Herr for a 21 raise. 22 Q. All right. 23 A. He told me I was doing great 24 work. Page 194 1 MR. ARMSTRONG: You don't need to 2 discuss your personal affairs, this is in the 3 middle of something that's obviously relevant, 4 but it is a personal entry. 5 Q. It goes on to say you would 6 carry Fluoxetine on a part-time basis. 7 MR. SMITH: Let me ask the questions, 8 Counsel, you can make an objection. 9 MR. ARMSTRONG: You can make the 10 objection. 11 MR. SMITH: Don't interrupt me. 12 MR. ARMSTRONG: Let's get this 13 straight, I'll do what I have to do to defend and 14 protect my client. 15 MR. SMITH: I'm asking him questions 16 and you're interrupting me without making an 17 objection. 18 MR. ARMSTRONG: If I interrupted you, 19 I apologize. But if you won't interrupt me when 20 I'm in the process of making an objection, we'll 21 get along fine. 22 MR. SMITH: We're not getting along 23 fine with you interrupting me. 24 MR. ARMSTRONG: I didn't know you were Page 195 1 so easily, readily bruised. 2 MR. SMITH: It's purple, but I'm going 3 to be okay if you'll let me continue my 4 questioning of this witness, all right? 5 MR. ARMSTRONG: Okay. 6 Q. Now, you said that you would 7 carry Fluoxetine on a part-time basis, is that 8 right? 9 A. Yes. 10 Q. Was this going to be after you 11 retired in December of '79 or before you retired 12 in December? 13 A. Before, until. 14 Q. Were you doing other work at 15 that time? 16 A. Yes. 17 Q. All right, and that was the 18 animal experiment you were in? 19 A. Yes. 20 Q. What was an interesting 21 possibility there? You say that is an 22 interesting possibility. 23 A. The fifty-fifty division of 24 time, the part-time. Page 196 1 Q. Would that mean that you would 2 just go to work for twenty hours a week? 3 A. No, that I would devote about 4 half time to Fluoxetine clinical trials and about 5 half time to my other research. 6 Q. I thought this was in fact 7 what you were doing? 8 A. Yes, it says interesting 9 possibility. 10 Q. Why do you call it a 11 possibility, I thought it was a fact? 12 A. I think we're going around in 13 circles. 14 Q. If there was going to be a 15 change, that's the only reason I was asking. If 16 there was going to be a change, I was going to 17 inquire about that. 18 A. I had been spending less time 19 preparing protocols and now I was going to spend 20 half time on the Fluoxetine. 21 Q. All right. The 2-26-79 talks 22 about revising the clinical brochure, is that 23 right? 24 A. Yes. Page 197 1 Q. Did you have original input 2 into the clinical brochure? 3 A. Yes. 4 Q. What input did you have 5 originally? 6 A. I don't remember the details, 7 but I think largely I had prepared the -- the 8 preparation had been largely my own 9 responsibility. 10 Q. Were the clinical brochures 11 and the investigators brochures the same? 12 A. Yes, uh-huh. 13 Q. It says Fasola, after sitting 14 on a very rough draft for about a month, decided 15 to cancel his appearance before the institutional 16 review committee. Who was Fasola? 17 A. He was one of the physicians 18 at the Lilly clinic. 19 Q. What institutional review 20 committee was he going to appear on? 21 A. I'm not sure whether it was 22 the university or the company's institutional 23 review committee, I think it was the -- I'm not 24 sure at this time. Page 198 1 MR. LORE: I'm sorry, Paul, you read 2 it as sitting on a very rough draft. Is that 3 very or my? 4 THE WITNESS: On my rough draft. 5 MR. LORE: On my rough draft. 6 Q. Now is that your rough draft, 7 the clinical brochure? 8 A. Uh-huh. 9 Q. Why would he have been taking 10 the clinical brochure before an institutional 11 review committee? 12 A. Because it's customary to have 13 an institutional review committee review clinical 14 brochures. 15 Q. Do you remember what clinical 16 trial it was that Fasola was conducting? 17 A. He wasn't conducting it, he 18 was the one who was going to present it to the 19 institutional review committee. 20 Q. So it was going to be 21 conducted by some other investigator? 22 A. Yes. 23 Q. Fasola really wasn't an 24 investigator, he was an in-house Lilly physician? Page 199 1 A. That's right. 2 Q. Was he a psychiatrist? 3 A. No. 4 Q. Why was he presenting it? 5 A. I think this was part of his 6 general responsibility. 7 Q. Is he still with Lilly? 8 A. I think he's retired. 9 Q. Let's go to the 3-8-79 10 notation. Would you read that for us, please? 11 A. All protocols of Fluoxetine 12 are now written, will visit next week. We should 13 be able to get him started by April, and Fabre, 14 and another investigator sometime in April. We 15 may get to the double-blind phase by July, will 16 start on protocols for that soon. 17 Q. When you say all protocols for 18 Fluoxetine are now written, are you talking about 19 those protocols for those three studies or these 20 studies that those three sites were going to be 21 done? 22 A. Yes. 23 Q. Do you recall now whether or 24 not you had any other help or assistance in Page 200 1 developing these protocols? 2 A. Oh, yes, I'm sure I did, but I 3 don't recall the details. 4 Q. Who would have been -- 5 A. I'm sure Doctor Fuller helped 6 me with the writing up the biochemical section, 7 and Doctor Wong, I'm sure that he had some 8 assistance, perhaps from other people whom I 9 can't -- 10 Q. Who would have been helping 11 you on the psychiatric portion of this? 12 A. I know I discussed some of it 13 with Doctor Stark. 14 Q. Doctor Stark is not a 15 psychiatrist? 16 A. No, but he had had some 17 experience in testing compounds since he was at 18 this time in the medical component. 19 Q. Testing compounds? 20 A. Drugs, yes, as a clinical 21 monitor. I may have discussed it with Doctor 22 Bennett who was a psychiatrist, I really don't 23 recall the details. 24 Q. I thought you were Page 201 1 dissatisfied with Doctor Bennett's performance in 2 these other studies he had done. 3 A. I was dissatisfied with the 4 amount of time that he had available to supervise 5 them, so the studies moved very slowly, but this 6 didn't mean that he was not capable of good 7 vision. 8 Q. On protocols? 9 A. Yes. 10 Q. You still had the availability 11 and Doctor Bennett was still willing to discuss 12 with you psychiatric aspects of the protocol? 13 A. Uh-huh. 14 Q. And is it your testimony that 15 you and he did discuss psychiatric aspects of 16 these protocols? 17 A. I think so, I'm not absolutely 18 sure, but I think. As I said, it's fifteen 19 years, and I -- 20 Q. Can you read for us the 21 notation on page thirty-seven dated 3-14-79? 22 A. Well, it was skipped. Visited 23 an investigator yesterday, he was ready to start 24 as soon as we can supply forms which should be by Page 202 1 March 28th, if his study progresses according to 2 his estimate, his optimistic projections, we 3 should have ten patients on the drug by the end 4 of April, this should give him some idea of 5 efficacy by the NCDEU meeting at the end of May. 6 He said if Fluoxetine doesn't work in an 7 open-label study, there's not too much reason to 8 believe that a double-blind study -- and it 9 should have said is worthwhile. He also wondered 10 whether the transient improvements that we have 11 had reported to us may represent inadequate dose. 12 Somebody mentioned in a recent telephone 13 conversation that he's not seeing as much change 14 in 5-HT uptake as Lemberger, which makes Lou 15 angry. Also side effects in the patients 16 receiving sixty-forty regimen are not that 17 different from thirty-twenty, so I would guess 18 that -- will juggle doses if he sees anything, 19 but he has promised to let me know so that we can 20 file amendments with the FDA PRN, which is as the 21 need arises. I think I should suggest to Bendush 22 and Shedden that I'll manage this Phase 2 23 Fluoxetine trial, and honestly turn it off if 24 open-label phase is completely discouraging, but Page 203 1 mention the tryptophan 5-HT and joint study with 2 Nortriptyline should be considered. I'll tell 3 them and Morton that I'll wind up my animal 4 studies on September 15th and release both Jones 5 and Moore for other studies, that if the clinical 6 Phase 2 trial is still in progress, I'll take 7 interrupted vacation, at least through February 8 15th, to see it to an end or to Phase 3. I would 9 like to go to NCDEU and would, if they wish, 10 recruit another psychopharmacologist. 11 Q. You say you would like to go 12 to NCDEU, what do those initials stand for? 13 A. I used to know, it's a meeting 14 of people who were interested in testing the 15 drugs on -- in neuropsychiatric things. Do you 16 remember what NCDEU is? 17 MR. LORE: No. 18 A. That's what it is, 19 essentially. 20 Q. Is NCDEU an in-house Lilly 21 group? 22 A. No, it's a national meeting of 23 people interested in drugs affecting psychiatric 24 disease. Page 204 1 Q. And you suggested that you 2 would like to go and recruit another 3 psychopharmacologist from that group? 4 A. No, that's not what it says. 5 Q. It says I would like to go to 6 NCDEU and would, if they wish, recruit another 7 psychopharmacologist. 8 A. Yes, but the two were not 9 necessarily saying that they were going to be 10 connected. 11 Q. Maybe I'm confused, Doctor 12 Slater, the words as I read them say I would like 13 to go to NCDEU and would, if they wish, recruit 14 another psychopharmacologist. 15 A. These were two things, one, I 16 wanted to do, and one I would be willing to do, 17 but it doesn't necessarily mean that I was going 18 to recruit the guy at NCDEU, I was going to 19 recruit, try and find another employee for the 20 company in the field of psychopharmacology but 21 not necessarily at the meeting. I have a few 22 months left, I would like to go to the meeting, 23 and in addition, if I have the chance, I would 24 like to find a psychopharmacologist. Page 205 1 Q. At the meeting? 2 A. No. 3 MR. ARMSTRONG: I object. 4 A. What difference does it make? 5 MR. ARMSTRONG: I think the witness 6 pretty clearly stated that the two were 7 unrelated. 8 Q. It says I'll tell them, 9 beginning on the bottom of the page, before page 10 thirty-eight, I'll tell them and Morton that I'll 11 wind up my -- is that annual? 12 A. Animal studies. 13 Q. Animal studies by September 14 15th. Who is Morton? 15 A. Morton was the man who was 16 executive director of certain phases of 17 biological research, there were two executive 18 directors -- no, he was my -- he was in charge of 19 the people who had formerly been my department, 20 and other people, but I did not report to him, I 21 reported to the man to whom I reported since I 22 was a -- I reported to Doctor Johnson, and so did 23 Doctor Morton, but Doctor Morton had 24 responsibility for the replacement of my Page 206 1 technicians after I retired. 2 Q. Did you ever report, Doctor 3 Slater, to any members of Eli Lilly and Company 4 that your clinical trials, the three clinical 5 trials under your direction, established that 6 Fluoxetine should be investigated further by Eli 7 Lilly and Company in connection with further 8 clinical trials for study of depression treated 9 with Fluoxetine? 10 A. Yes. 11 Q. When was that that you 12 notified them of that? If it's later on, we'll 13 go through that later on, I think you have some 14 written memorandum from that. 15 A. I think I may, I'm not sure, I 16 don't remember. 17 Q. When you say you were 18 releasing Jones and Moore for other studies, who 19 are Jones and Moore, your technical assistants? 20 A. Yes, my technicians. 21 Q. Read for us the April 12, '79 22 memo. 23 A. The Japanese fifty-five year 24 old physicist at Stanford is still not improved Page 207 1 while taking Fluoxetine. During first week, dose 2 was reduced from sixty to fifty because of 3 lethargy and hypotension. At the end of the 4 second week, I note in the SCL ninety that he is 5 nauseated, one or two weeks more and then what. 6 And this has gone on since the report of 3-27. I 7 had to sit still. I do hope that he will consent 8 to a spinal tap. 9 Q. Is it I have to sit still or 10 it's hard to sit still? 11 A. It's hard to sit still. 12 Q. All right. Tell me what 13 you're referring to in questioning this entry, 14 Doctor Slater? 15 A. I think this is something, I 16 don't remember very well, and I don't know where 17 this patient came from, I think we hoped that by 18 a spinal tap we could see whether there would be 19 an increase in spinal fluid levels of serotonin. 20 This was a patient who was depressed. 21 Q. How do you know that? 22 A. I'm inferring it from what it 23 seems. 24 Q. What in there gives you the Page 208 1 inference that it was a patient who was 2 depressed? 3 A. There's nothing that 4 establishes it, it's just my impression from -- I 5 don't have any good data to back it up. 6 Q. Go ahead with your explanation 7 of the problem presented by this patient. 8 A. That's all there is, that's 9 all I know about it. 10 Q. Was this a patient that was in 11 a clinical study? 12 A. I don't know where he came 13 from, I told you. 14 Q. Do you know why you would be 15 making a notation concerning this particular 16 patient at this particular time? 17 A. I apparently got a report from 18 somebody, but I don't recall where it came from. 19 Q. Were you getting reports in 20 connection with patients being given Fluoxetine 21 from any other source, Doctor Slater, other than 22 the clinical trial patients? 23 A. I was getting reports from the 24 doctor who had the patient with the musculorum Page 209 1 deformans, and this may have been a patient left 2 over from Doctor Shulman's studies, but I'm not 3 sure. I told you I don't know where this data 4 came from. 5 Q. Is this patient deteriorating, 6 can you tell that from looking at your note? 7 A. What? 8 Q. Is this patient deteriorating, 9 is he having a problem? 10 A. My impression is that he was 11 having some side effects from relatively high 12 doses of Fluoxetine, than what we know now, and 13 that's all I can say. 14 Q. You say I note in the SCL 15 ninety that he's nauseated. What is the SCL 16 ninety? 17 A. I don't remember. 18 Q. Would that have been a 19 clinical report form? 20 A. It could be. 21 Q. It says one or two more weeks 22 and then double question. Do you have any 23 recollection of what one or two weeks you're 24 talking about? Page 210 1 A. No. 2 Q. And then what you're 3 questioning there -- 4 A. This entry is a complete 5 mystery to me at this time. 6 Q. Do you have any recollection 7 at all about the Stanford physician? 8 A. No. 9 Q. You hadn't thought about him 10 in years until you saw these notes? 11 A. Yes. 12 Q. And then after you saw these 13 notes, it didn't refresh your recollection at all 14 as to what you were talking about? 15 A. Right. 16 Q. Turn to the 4-26-79 notation. 17 Can you read that for us? 18 A. Doctor so and so's protocol 19 approval and budget came in. The protocol 20 approval was by his institution. He was proposed 21 for a six-patient pilot study. I told him there 22 is no way, and Doctor Bendush agreed. I think 23 this refers to the analgesic studies that were 24 being proposed in San Diego, and the more I talk Page 211 1 with this particular investigator, the less I 2 thought that he would give me any useful 3 information, and he asked for an outrageous 4 budget, which I refused to support. 5 Q. Then you have a period, 6 Bendush agreed to this. 7 A. I told him there was no way. 8 Q. That Bendush would agree, you 9 meant that there was no way that Bendush would 10 agree with this? 11 A. No, that he agreed that we 12 shouldn't. 13 Q. Oh, Bendush agreed with you 14 that there was no way that they would fund the 15 study. Look at the second line there where it 16 says he was, and then there's a space and it says 17 for the six-patient study, is there something 18 marked out of that? 19 MR. ARMSTRONG: I think there is, I 20 think there's a dollar amount. 21 MR. SMITH: Oh, okay. 22 A. Was it -- 23 MR. ARMSTRONG: It reads funny because 24 it should say want, I think, instead of was, but Page 212 1 I think that's what was there, a dollar amount. 2 A. That's right, it should have 3 read want, he wanted some thousands of dollars. 4 MR. SMITH: Let's take a break. 5 (A SHORT RECESS WAS TAKEN.) 6 Q. Let's turn to page 7 forty-three, the notation that you made on May 8 15, 1979. 9 A. The meeting with Shedden and 10 Bendush went well, as did presentation with Herr 11 staff. As of today, we have fragmentary evidence 12 of efficacy, and we had best be sure quickly. A 13 slow deliberate approach will land us a year or 14 two behind ziuelidine, fluoxemine and puroxetine, 15 and therefore be worthless. This refers to the 16 need to make a decision about extending the 17 clinical trial. 18 Q. Who is Herr's staff? 19 A. Doctor Herr was the executive 20 vice-president in charge of research and 21 development, and I think also production. He had 22 a big job. 23 Q. And he would have been the one 24 that would have made the ultimate corporate Page 213 1 decision on whether or not to continue the 2 clinical trials? 3 A. Right, his staff would make 4 the decision. 5 Q. Obviously based in part on 6 your recommendation? 7 A. On my recommendation, and 8 Doctor Shedden, and Doctor Bendush, and Doctor 9 Marsden. 10 Q. As of today, we have 11 fragmentary evidence of efficacy, and then you 12 say and we'd best be sure quickly. I get from 13 your -- the tenor of your note that there was 14 some uncertainty in your mind or at least in this 15 meeting in questioning whether or not the product 16 was efficacious. 17 A. Yes. 18 Q. Then you go on to say that a 19 slow deliberate approach will land us a year or 20 two behind, and then you go ahead and actually -- 21 what you do is you list competitive 22 antidepressant drugs that were being developed by 23 other pharmaceutical companies at the time. 24 A. Correct. Page 214 1 Q. And you were afraid that if 2 you took more time to examine your fragmentary 3 evidence, that the other competitive companies 4 might get a jump on you, that you would never be 5 able to make up, is that right? 6 A. Right. 7 Q. And if the other product came 8 on the market before Fluoxetine as Prozac, it 9 would be worthless? 10 A. Well, it would be an uphill 11 fight, at best. 12 Q. Your word is worthless, is it 13 not? 14 A. Huh? 15 Q. You wrote the word worthless. 16 A. Yes. 17 Q. On 5-18-79, would you read 18 that notation? 19 A. Off to NCDEU, why do 20 Fluoxetine patients start off well and then fade. 21 Do we need L-5 HTP, Molloy says it should cost 22 about twice as much as L dopa and be almost as 23 stable. I told Bendush we would need more 24 perceptive open-label trials with Dienzapine and Page 215 1 tricyclics and so on. 2 Q. All right. Again, do you 3 remember what NCDEU is, it's a group of people in 4 the business? 5 A. I would just be misleading you 6 if I tried to make up an answer. 7 Q. Why do Fluoxetine patients 8 start well and then fade. What evidence did you 9 have at that time that Fluoxetine patients were 10 starting well and then fading? 11 A. The fragmentary evidence that 12 I hadn't had. 13 Q. Based on the clinical trial 14 data that you received up to May of 1979? 15 A. Uh-huh. 16 Q. Is that a yes? 17 A. Yes. 18 Q. And when you say they fade and 19 then fade specifically, what are you referring 20 to? 21 A. The impression I was getting 22 was that the patients seemed to do well for a 23 week or so, and then seemed not to do as well. 24 Q. Becoming more depressed or Page 216 1 exhibiting more side effects? 2 A. Have a recurrence of 3 depression. 4 Q. They would become less 5 depressed and then return to their original 6 baseline depressive state? 7 A. Yes, toward, not to. 8 Q. Now, are you talking about 9 changing the medication Fluoxetine to add L 10 tryptophan, is that -- when you say do we need 11 L-5 HTP, is that what you mean, do we need to add 12 L tryptophan? 13 A. L hydroxy-tryptophan, 14 tryptophan, yes. 15 Q. And would that be where you 16 would get Fluoxetine in conjunction with -- 17 A. Yes. 18 Q. -- L tryptophan? 19 A. L hydroxy-tryptophan. 20 Q. Was that ever done? 21 A. No. 22 Q. Why did you note that there, 23 that that might be a possibility on something? 24 A. Because that's a precursor for Page 217 1 serotonin. 2 Q. Did you think that would 3 alleviate the problems of the patients who had 4 started well and then faded? 5 A. I thought it might. 6 Q. Then you say Molloy says it 7 should cost two times L dopa, is that right? 8 A. Yes. 9 Q. It would cost two times as 10 much to add L dopa? 11 A. No. As a chemical, the cost 12 of this chemical would be about double what L 13 dopa would cost. 14 Q. The L tryptophan and 15 Fluoxetine would cost twice as much as L dopa? 16 A. Uh-huh. 17 Q. Is that a yes? 18 A. Yes. 19 Q. Is L dopa an expensive 20 medication? 21 A. Not terribly. 22 Q. Why was the cost -- did Doctor 23 Molloy say why the cost would be something that 24 should be factored in? Page 218 1 A. Well, I didn't know how 2 difficult it was to make or to get 3 hydroxy-tryptomine or L-hydroxy-tryptomine, so I 4 asked is this something which would be feasible. 5 If it was going to cost several hundred dollars a 6 gram for the L5 hydroxy-tryptomine, that 7 obviously would be out of the question, and he 8 said it would only be about twice the cost of 9 L-dopa and L-dopa is used in very large doses. 10 Q. Was there a cost consideration 11 going on here in this time span? 12 A. It's not a major 13 consideration, it's only to the extent that if 14 the experiment was scientifically necessary, 15 would it be financially feasible. You obviously 16 can't add the L5 hydroxy-tryptomine if it were a 17 phenomenally expensive material. 18 Q. You go on to say, I told 19 Bendush -- am I saying that right? 20 A. Bendush. 21 Q. That we need more perceptive 22 open-label trials. What do you refer to when you 23 say more perceptive open-label trials? 24 A. I'm not sure. Page 219 1 Q. What is your judgment on what 2 you're talking about there? 3 A. I was thinking at this time 4 that if the compound only was giving transient 5 improvement, would the addition of a compound 6 that inhibited the uptake of other transmitters 7 or otherwise modified the brain function make the 8 Fluoxetine a more useful drug. 9 Q. Okay. So you had Fluoxetine 10 at the time that was, I think it's been called a 11 pure drug up to that point, is that correct? 12 A. Yes. 13 Q. And that was what was one of 14 the impugning things about Fluoxetine was that it 15 was a pure drug and affected serotonin only. 16 A. Yes. 17 Q. As far as could be told at 18 that time, is that right? 19 A. Yes. 20 Q. And you felt like that some 21 consideration, because of the fragmentary results 22 of the patients beginning to fade, you felt like 23 at that time in May of '79 that it might be 24 relevant to consider adding medications that Page 220 1 affected other brain chemicals to prevent this 2 problem of the people fading? 3 A. Right. 4 Q. And you mentioned tricyclics, 5 which are other antidepressants, is that right? 6 A. Uh-huh. 7 Q. And then you mentioned 8 Diazepam? 9 A. Uh-huh. 10 Q. And Diazepam -- 11 A. It's a Valium and things like 12 that. 13 Q. It's an anti-anxiety agent? 14 A. Yes. 15 Q. It's not an antidepressive at 16 all, is it? 17 A. No. 18 Q. And wasn't it your thoughts 19 that you were going to add these Valium type 20 drugs to reduce the anxiety side effects that had 21 been seen in these studies? 22 A. We hadn't seen that, nothing, 23 I don't see anything that indicates that we were 24 seeing anxiety. Page 221 1 Q. You don't recall that at this 2 time? 3 A. No. 4 Q. Then why would you have been 5 writing that you had Diazepam? 6 A. It was just something off the 7 top of my head at the time, it was not a proposal 8 to anybody except to my diary that we might have 9 to do away with the purity. I had always had the 10 theory that most effective drugs have multiple 11 effects and maybe a very pure drug was not as 12 much to go to the Holy Grail as one might expect. 13 I should say it turned out I was wrong. 14 Q. Maybe so, maybe no, Doctor 15 Slater. 16 A. Well, I think -- 17 Q. You see, we have a lot of 18 references to anxiety that showed up in the 19 clinical trials that you oversaw that you were 20 concerned about. 21 MR. ARMSTRONG: Is that a question? 22 MR. SMITH: No. 23 A. Where do you get that 24 information? Page 222 1 Q. I beg your pardon? 2 A. Where did you get that 3 information? 4 Q. From Lilly. I'll show it to 5 you tomorrow or later this afternoon, but I'm 6 giving you an opportunity now to reflect, and the 7 reason I bring it up now is because of your entry 8 concerning the benzodiazepams and the addition of 9 this antianxiety medication to Fluoxetine to 10 cause it to be a more effective and less side 11 effect causing antidepressant. 12 A. Okay. 13 Q. Did you have a thought? 14 A. No. 15 Q. All right. Continue then with 16 the 5-30-79 entry. Would you read it for us, 17 please? 18 A. Well, at the NCDEU meeting 19 last week, I was impressed how difficult it would 20 be to design and carry out a meaningful 21 double-blind study with Fluoxetine. I had hoped 22 to compare Fluoxetine with Amytryptiline but one 23 of the investigators whose named is blanked out 24 pointed out there would be no double-blind. Page 223 1 Would you like me to explain that? 2 Q. Yes. 3 A. All the effective 4 antidepressant have all sorts of side effects and 5 Fluoxetine is relatively free, so you have a 6 double-blind study and the patient came in and 7 said doctor, I'm feeling so and so but my mouth 8 is as dry as a bone, this patient isn't on 9 Fluoxetine, that's not a double-blind study, 10 that's what this refers to. 11 Q. Do you agree with that? 12 A. Sure, I think that's what the 13 whole world is about. 14 Q. Go ahead. 15 A. In addition, I suspect that 16 Fluoxetine might not affect as many patients as 17 Amytryptiline. 18 Q. Why did you -- let me stop you 19 there. Why did you have that suspicion? 20 A. I had a deep prejudice that 21 Adrenalin and Noradrenalin were more important 22 neurotransmitters than 5 hydroxy-tryptomine, this 23 goes back at least to some research that I did in 24 the '50s, but that's just prejudice, it's not Page 224 1 fact. 2 Q. I get the impression that just 3 a few pages before this, that you are being 4 praised for your continued work in Fluoxetine and 5 you're a staunch supporter of Fluoxetine and 6 Fuller, Wong and Molloy are your boys that you 7 recruited, correct? 8 A. Yes. 9 Q. But I get the impression here 10 in these last few entries that you're beginning 11 to have some second thoughts in your own mind in 12 your journal entry about whether or not this pure 13 drug, Fluoxetine, might be the best drug that you 14 could come up with. 15 A. I had, at this time had never 16 conceived that Fluoxetine would be as successful 17 of a drug as it was. 18 Q. All right. 19 A. I had hopes that it would 20 offer benefit to some patients and I thought it 21 was a worthwhile addition to being able to help 22 people, but I didn't expect it would be as 23 successful as it is. 24 Q. And you were certainly having Page 225 1 some mixed feelings in May of '79 concerning it? 2 A. I had no doubt that we ought 3 to go ahead and that it was an important thing to 4 complete, that it would be effective in some 5 patients, but I didn't think that it would be as 6 broadly effective as the then available drugs. 7 Q. Then you say, finally it 8 dawned on me that my old feelings -- 9 A. That our best bet for a 10 successful combination would be a combination of 11 an inhibitor, norepinephrine. 12 Q. With F? 13 A. With Fluoxetine. I discussed 14 this with Fuller, Stark, Morton, Raffey, Whale, 15 Ostow and Shedden, and the medical directors. I 16 don't know who Whale is. 17 Q. Who is Raffey? 18 A. Raffey is a chemist who became 19 the director of the CNS group after the final 20 reorganization which caused me to retire or which 21 preceded my retirement. 22 Q. When was the reorganization? 23 A. 1978. Ostow is an old friend 24 of mine. Page 226 1 Q. Is he a Lilly employee? 2 A. No, no, he's a psychiatrist. 3 I called him on the telephone, that's the only 4 time I talked to him in the fifty-five years 5 since we graduated from medical school, and I 6 asked him did he think that an inhibitor of 7 serotonin would be effective or would it be more 8 effective to have a combination of serotonin and 9 norepinephrine. 10 Q. And what was his response? 11 A. He thought it would be worth 12 testing both possibilities. 13 Q. Was that ever done? 14 A. No, I could never convince 15 anybody to do that. 16 Q. What is Doctor Ostow's first 17 name? 18 A. He's Doctor Mortimer Ostow, 19 and I'm sure that he has no recollection of this 20 telephone conversation. 21 Q. Where is he located? 22 A. In New York, New York, I think 23 at Riverdale. 24 Q. Riverdale? Page 227 1 A. I think. 2 Q. Is he still in practice? 3 A. He was a classmate of mine and 4 we're all seventy-five, so that's -- but he's a 5 psychiatrist who had had a Freudian type of 6 training but became interested in drug therapy. 7 Q. Had he done some clinical 8 trials? 9 A. No. 10 Q. Is that a no? 11 A. Not that I know of. 12 Q. Do you know whether or not he 13 had had some particular training in neuro 14 psychopharmacology? 15 A. No. 16 Q. You don't know? 17 A. I know he didn't. His 18 training is all in psychiatry and neurology. 19 Q. But you respected his judgment 20 on this matter? 21 A. He's a very bright guy, or he 22 was fifty years ago. 23 Q. Go ahead, I'm sorry I 24 interrupted you, Doctor Slater. Page 228 1 A. Clearly we must first show 2 that Fluoxetine alone has some activity, this 3 morning I'm inclined to run Fluoxetine against 4 placebo for three weeks and if nothing happens to 5 go to Amytryptiline, then compare rate of 6 improvement of Fluoxetine against placebo, 7 Fluoxetine plus Amytryptiline and then placebo 8 and Amytryptiline. 9 Q. All right. Did you ever do 10 that? 11 A. No. 12 Q. Why? 13 A. The oriental physicist seems 14 to respond quickly to Amytryptiline after 15 Fluoxetine, when in the past he had not done well 16 on Imiprimine. Imiprimine and Amytryptiline have 17 relatively similar pharmacology. 18 Q. This is back to the physicist 19 from Stanford? 20 A. Yes. 21 Q. Does that help you any going 22 back over? 23 A. No. 24 Q. Continue. Page 229 1 A. Our cat data with REM sleep 2 suggests some sort of additive effect. 3 Q. Additive to what? 4 A. I'm not sure, probably we may 5 have done experiments with mixing Amytryptiline 6 and Fluoxetine or something of the sort, but I 7 don't recall that. I talked with an old friend 8 whose name is blanked out, at something, he has 9 had some experience with Fluoxemine and would be 10 willing to do studies with Fluoxetine in, and 11 then he mentions two places where he could do the 12 study. 13 Q. Let me stop you a second, 14 Doctor Slater. You say I talked with, and then 15 you say what is blacked out of here is an old 16 friend's name? 17 A. That's what he is, he's an old 18 friend. 19 Q. All right. 20 A. His name is blanked out. 21 Q. What is blanked out is not an 22 investigator? 23 A. Yes, he is an investigator who 24 was an old friend of mine. He is somebody I knew Page 230 1 before the war. 2 Q. Okay. 3 A. The war. 4 Q. W-W-2? 5 A. Yes. 6 Q. But then he became an 7 investigator that was hired by Eli Lilly and 8 Company? 9 A. Oh, no, no, no. I had met him 10 at an NCDEU meeting. 11 Q. He wasn't a Lilly investigator 12 investigating Fluoxetine? 13 A. No, no, no. 14 MR. SMITH: I think under the court's 15 ruling, I'm entitled to that name. 16 MR. ARMSTRONG: It sounds like it to 17 me. 18 MR. LORE: It sounds like it. 19 MR. ARMSTRONG: Tell him. 20 A. It says at Key Biscayne, which 21 is where the NCDEU meeting was. 22 MR. ARMSTRONG: He wants the name too, 23 Doctor, the name of the doctor. 24 THE WITNESS: You want -- he's not a Page 231 1 key investigator? 2 MR. ARMSTRONG: So he's entitled to 3 know his name. 4 THE WITNESS: What? 5 MR. ARMSTRONG: He's entitled to know 6 your old friend's name. 7 THE WITNESS: Why? 8 MR. ARMSTRONG: Because he's not on 9 the list of investigators that Lilly is not 10 obliged to disclose, he's not a part of a study. 11 A. Oh, his name is Hy Denber, 12 D-E-N-B-E-R, he never did a study for Lilly. 13 MR. ARMSTRONG: That's the reason why 14 he's -- 15 Q. Is his name H-Y? 16 A. Yes. 17 Q. D-E-N-B-E-R? 18 A. Uh-huh. 19 Q. Where is he located? 20 A. The last time I talked with 21 him, I think he was in Spring Valley, New York, 22 but I don't know. 23 Q. Is he a psychiatrist? 24 A. Yes. When I knew him he was Page 232 1 an intern in pathology when I was an intern in 2 medicine and then he went on and got training in 3 medicine and then got training in psychiatry and 4 did some drug testing. 5 Q. You say he has had experience 6 with Fluoxetine and would be willing to do 7 studies? 8 A. No, Fluoxemine. 9 Q. Fluoxemine, okay. What is the 10 difference in Fluoxetine and Fluoxemine? 11 A. One belonged to Lilly and one 12 belonged to somebody else. 13 Q. Two different -- 14 A. They're entirely different 15 drugs. 16 Q. Are they both specific 17 serotonine reuptake inhibitors? 18 A. I don't know how specific 19 Fluoxetine is, but I think it's relatively 20 specific. 21 Q. Is Fluoxemine an 22 antidepressant? 23 A. I don't know if it was a 24 successful -- whatever happened to it. Page 233 1 Q. You don't know that it's now 2 being marketed under some trade name? 3 A. No. 4 Q. By some company as a -- 5 A. Yes, I don't know. 6 Q. He has had experience with 7 Fluoxemine and would be willing to do studies 8 with Fluoxetine, and where are the locations that 9 he would do the studies? 10 A. I think it was Nashville and -- 11 where else, Mary? 12 MR. ARMSTRONG: Louisville and 13 Switzerland. 14 Q. He would do the studies either 15 in Louisville, Kentucky or Switzerland? 16 A. Uh-huh. Some of these guys 17 are big. 18 Q. That's quite a spectrum there. 19 A. I think this is the real 20 Switzerland. 21 Q. You go on to say, would he or 22 his friend -- and then that's marked off. 23 A. This is the guy who did do 24 studies for Lilly. The kind of investigator to Page 234 1 give us some positive results with Fluoxetine 2 alone. 3 Q. Now, is it your testimony that 4 this individual who is blanked out here was an 5 investigator? 6 A. Became an investigator, yes. 7 Q. Do you know whether that 8 individual did pivotal studies for Lilly? 9 A. I don't have the list. 10 MS. HUFF: This is one I should not 11 have masked because he was pivotal. 12 A. This is Doctor Masco in New 13 Port Richey. 14 Q. Masco in New Port Richey? 15 A. Yes. 16 Q. New York? 17 A. Florida. 18 Q. He would -- let's go ahead and 19 get back to the study, or his friend Masco in New 20 Port Richey, Florida would be the kind of 21 investigator to give some positive results with 22 Fluoxetine alone, is that right? 23 A. Uh-huh. 24 Q. How did you know that these Page 235 1 investigators were the kind of investigators that 2 would give positive results with Fluoxetine 3 alone? 4 A. I thought they were competent 5 investigators from talking with them and from the 6 way other people treated them at the meeting. 7 Q. You say you thought these 8 people were competent investigators, based on 9 your discussions with them, to get positive 10 results. Did you have -- 11 MR. ARMSTRONG: Let me interrupt and 12 suggest you look at the way the sentence starts, 13 which appears to me to be a question, would he or 14 his friend be the kind of investigators. 15 Q. Okay. 16 A. I should have written a 17 question mark. 18 Q. It would have probably been 19 marked out if you had put it in there. 20 Did you have some complaint 21 with some of the investigators' competence who 22 had found less than positive results with -- 23 A. The data at this point was 24 somewhat fragmentary as I said and what I wanted Page 236 1 was a definitive answer. By positive results, I 2 think I meant definitive, not yes, no, not only 3 yes but I meant yes or no. Do you know what I 4 mean? 5 Q. You say would he or his friend 6 be the kind of investigator to give us some 7 positive results with Fluoxetine alone, don't 8 you? 9 A. Yes, and the word positive in 10 this sense should mean definitive rather than 11 favorable. I think the word can have either 12 meaning, but I would like it to reflect my 13 intent. My role had not changed, I was still 14 trying to establish should we or shouldn't we. 15 Q. But you weren't neutral in 16 your beliefs -- 17 A. Of course not. 18 Q. -- in that Fluoxetine would be 19 a beneficial antidepressants, were you? 20 A. I was not neutral in my hopes, 21 certainly, but I tried to be honest in my 22 approach. 23 Q. I'm not questioning that but 24 I'm -- Page 237 1 A. This was my baby, what the 2 hell. 3 Q. Yes, all right. Read the 4 6-9-79 notation. 5 A. I would have to know who the 6 investigator -- can I see the copy? 7 (LILLY'S ATTORNEY SHOWS DOCUMENT TO WITNESS.) 8 A. Yes, this is another very, 9 very esoteric study, has good results with one 10 patient treated with two hundred milligrams of 11 L-5 HTP and Fluoxetine better than before with 12 1200 milligrams alone, this investigator was 13 examining a very rare muscle disease which is 14 brought on -- the name of which I have forgotten, 15 and this is a peripheral effect primarily, I 16 think although it may have been a central effect 17 but it has nothing to do with depression. 18 Q. But it does have something to 19 do with Fluoxetine, doesn't it? 20 A. Yes, it has to do with 21 Fluoxetine. 22 Q. Is the name that is marked out 23 there the name of an individual? 24 A. Yes. Page 238 1 Q. Who did clinical trials? 2 A. Yes, he did. 3 Q. On Fluoxetine? 4 A. Well, he did -- yes, very 5 small. 6 Q. Was he a pivotal investigator? 7 A. Oh, no. 8 Q. But he was hired by Lilly? 9 A. No, we just supplied him with 10 material. 11 Q. So he didn't do a study, he 12 wasn't an investigator then that did a clinical 13 trial for Lilly? 14 A. He was an investigate who used 15 Fluoxetine but he was not being as I recall 16 supported by Eli Lilly and Company, he had other 17 support for the studies. 18 MR. SMITH: Then I think I'm entitled 19 to his name. 20 MS. HUFF: We need to check that. 21 MR. ARMSTRONG: We'll check that 22 tomorrow. 23 MR. LORE: Can we do that, Paul, it 24 was my understanding that he was a nonpivotal Page 239 1 investigator. 2 MR. SMITH: The witness's recollection 3 is that he used Fluoxetine but his study wasn't 4 funded by Lilly. 5 MR. LORE: It may have been he did 6 other studies after Doctor Slater was out. 7 MR. SMITH: Check it out. 8 MR. LORE: I will, that has been the 9 case with other names. 10 Q. Now, the last -- this is the 11 last sentence here, it says now to deal with, and 12 then you list names. I can't really read your 13 writing, Doctor Slater. 14 A. Well, I can. The first name, 15 I don't know who that is, Christenson. These are 16 the people in the group that were -- had the 17 responsibility for seeing the data were 18 transmitted to the FDA. 19 Q. Then you say now to deal with 20 Christenson and Barnett, et cetera. 21 A. Uh-huh. 22 Q. What are you speaking of? 23 A. Making sure that they would 24 get the results and transmit them to the FDA Page 240 1 according to the standard procedure. 2 Q. The results, these good 3 results were the patient treated with two hundred 4 milligrams of L-5 HTP and Fluoxetine? 5 A. Yes. 6 Q. What does your 6-18-79 7 notation say? 8 A. Oh, you want -- trying to 9 enlist more Fluoxetine investigators, not happy 10 with Fabre, wrote asking him to return pills, 11 forms and four-fifths of the grant, he had had 12 one patient at this time. 13 Q. What was your complaint with 14 Fabre? 15 A. Apparently nothing was getting 16 done. 17 Q. Do you specifically remember 18 that was your complaint with Fabre? 19 A. I think so, that's why I asked 20 for four-fifths of the grant be returned. I 21 don't specifically remember, this is the 22 inference I'm making at this time. 23 Q. Did you have any 24 correspondence with Doctor Fabre requesting that Page 241 1 he discontinue his work and return the pills and 2 forms and four-fifths of the grant to you? 3 A. What did you say? 4 Q. Did you have any 5 correspondence with Doctor Fabre asking him to 6 return the pills and the forms? 7 A. It says I wrote to him and 8 asked him. 9 Q. Where does it say you wrote -- 10 oh, wrote asking him, you're right, I'm sorry. 11 Do you recall whether you got any response? 12 A. Yes, he agreed to do a 13 double-blind study but wanted a Lilly more 14 experience and wanted to go with imiprimine. 15 Q. I don't understand Doctor 16 Fabre on June 18, 1979, you are not happy with 17 Fabre and you wrote asking him to return the 18 pills, forms and four-fifths of his grant, and 19 then eleven days later, it appears that you've 20 hired him to do a double-blind trial. 21 A. He was already hired and he 22 agreed to get this moving. See, we didn't think 23 it necessary to get our money back and so on. 24 Q. Well -- Page 242 1 A. I think the next, that people 2 are not investigators, then it says Tom Ban, 3 B-A-N, was to have sent us protocols but nothing 4 came, called to make an appointment in Nashville. 5 Q. Hold off just a second and let 6 me look at this real quick, Doctor Slater. 7 A. This is a -- the next guy is a 8 pivotal investigator. I called to make an 9 appointment to talk to Doctor Ban in Nashville 10 but I don't remember ever seeing him, the next 11 thing is Doctor Bremner will be ready in October 12 or November, we'll also try Denver and Masco 13 then. 14 Q. You said Bremner will be ready 15 in October or November. 16 A. Uh-huh. 17 MR. SMITH: Hold on just second. 18 (A SHORT BREAK WAS TAKEN.) 19 (PLAINTIFFS' EXHIBIT NO. 3 WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Doctor Slater, this is a 23 letter you wrote back in June of 1989. Would you 24 take a look at that and familiarize yourself with Page 243 1 it? 2 A. Yes, that's interesting. 3 Q. Is that the letter you wrote 4 to Doctor Fabre? 5 A. I guess so. 6 Q. Requesting that he return the 7 pills to you as you mentioned in your notation of 8 June 18 -- 9 A. Yes. 10 Q. -- '79. 11 A. Apparently I really did write 12 to him after all. 13 Q. And you were dissatisfied 14 because he couldn't do a single-blind study, 15 weren't you? 16 A. I was dissatisfied that he had 17 only done one patient and we were getting nowhere 18 fast. 19 Q. And this was a single-blind 20 study, wasn't it? 21 A. Yes. 22 Q. I'm curious as to any 23 explanation as for why eleven days later you 24 would, in this you would ask him to do a Page 244 1 double-blind study involving Imiprimine? 2 A. Apparently he was able to 3 convince me that he would do this. 4 MR. ARMSTRONG: Let me object here, 5 because if you read the sentence, that first 6 sentence in the entry, 6-29-79, he starts off 7 talking about Fabre has agreed to do a 8 double-blind trial. But so and so, a blanked 9 name, that is another person, not Fabre. 10 MR. SMITH: All right. 11 MR. ARMSTRONG: He wants a little more 12 experience. 13 Q. Look at your note, is that 14 another person or is that the same person? 15 A. That's another person. 16 Q. So but it's definite that you 17 hired Fabre to do another study, haven't you? 18 A. Uh-huh. 19 Q. A double-blind trial, is that 20 correct? 21 A. Yes. 22 Q. And that double-blind trial, 23 do you recall whether or not they had a 24 comparitor drug? Page 245 1 A. No. 2 Q. Do you recall doing protocols 3 and hiring Doctor Fabre to do double-blind trials 4 on a comparitor drug? 5 A. This is all I recall. I made 6 a second visit to Houston and talked with him. 7 Q. Between June 18, 1979 and June 8 29, 1979? 9 A. I don't remember when it was. 10 Q. Tell me about your second 11 visit. 12 A. Since I really can't place the 13 timing of it very well, my recollection is rather 14 vague. I had the impression that he thought that 15 he had some data that suggested that Fluoxetine 16 might be a useful drug. That's about the best I 17 can offer you. 18 Q. Well, you had asked that he 19 discontinue the one single blind study and return 20 the medication to you, correct? 21 A. Uh-huh. 22 Q. And return four-fifths of his 23 grant money back to you? 24 A. Yes. Page 246 1 Q. And then eleven days later, 2 you had apparently, is it your testimony that you 3 had talked to him and he had convinced you that 4 he could do an even more complicated study? 5 A. Yes. 6 Q. Involving more patients? 7 A. Uh-huh. 8 Q. Is that a yes? 9 A. Yes. 10 Q. Involving more paperwork? 11 A. Yes. 12 Q. Involving more medication? 13 A. Yep. 14 Q. What was it that he did or 15 said that convinced you that he was capable of 16 taking on a bigger project when he had 17 demonstrated to you that he wasn't able to handle 18 the single-blind project? 19 A. I think you're putting an 20 unwarranted construction on -- what happened was 21 that he had not done it. It didn't prove that he 22 was incapable of doing it, he just hadn't done 23 it, but he promised that he would do it this 24 time. Page 247 1 Q. Well, at least he was 2 incapable of getting it done when you wanted it 3 done, can we agree with that? 4 A. He had not gotten it done, he 5 had apparently gotten involved with other 6 studies. 7 Q. And you wrote in your 6-18-79 8 note not happy with Fabre. 9 A. Yes. Well, I think that's 10 reflected in the letter that you have as Exhibit 11 3. 12 MR. SMITH: Why don't we break there 13 if that's all right with you all. 14 (A SHORT BREAK WAS TAKEN.) 15 MR. LORE: Could I make an objection 16 for the record, though, Paul. This was the first 17 time -- 18 MR. SMITH: We have never been picky 19 about when you can make an objection. Jim and I 20 are making them in the middle of sentences. 21 MR. LORE: I'm nice, I'm a very nice 22 person. But this was the first time I had seen 23 this document, I saw it the same time you did, 24 meaning the portion of the diary, and on behalf Page 248 1 of Lilly, I would like to object to any of the 2 entries or discussions had about the entries 3 dealing with drugs or medicines which were not 4 marketed and I can think of Nizoxetine would fall 5 in that category and also additionally, any names 6 that were reflected in any entries or discussions 7 of nonpivotal investigators where the names were 8 not blacked out, or investigators that may have 9 worked on other additional medications, and then 10 there was some discussion there about grants and 11 monies, I think, in connection with other 12 medications, but I also object to that based on 13 the ruling of the commissioner and finally any 14 entries or discussions regarding the use of 15 Fluoxetine in patients for other -- patients 16 suffering from other conditions other than 17 depression. 18 MS. MORTIMER: I would like to certify 19 all the questions where the witness was directed 20 not to answer by his attorney for the record. 21 MR. SMITH: Apparently Kentucky has 22 the procedure where when an attorney instructs a 23 witness not to answer the question, that the 24 opposing attorney has to certify it, that Page 249 1 question. 2 MR. ARMSTRONG: Yes, I heard that, and 3 I understand that the failure to do so instantly 4 after the direction, waives it. 5 MR. SMITH: Put it in there. 6 MS. MORTIMER: I can ask them all 7 again at the end. Do you agree, now that I've 8 said that? 9 MR. ARMSTRONG: You have preserved the 10 record. 11 (QUESTIONS CERTIFIED.). 12 13 * * * * * * * * * * 14 (THE DEPOSITION WAS RECESSED UNTIL 15 THE FOLLOWING MORNING, AT WHICH TIME 16 THE DEPOSITION RESUMED AS FOLLOWS:) 17 18 * * * * * * * * * * 19 20 CONTINUING DIRECT EXAMINATION 21 BY MR. SMITH: 22 Q. Doctor Slater, we're 23 continuing your deposition from yesterday. 24 Obviously the oath that you took yesterday is Page 250 1 still in effect, and the testimony you give here 2 today, as yesterday, will be used as evidence in 3 the trial of these cases. Do you understand 4 that? 5 A. Yes. 6 Q. Over the evening, have you 7 thought of any of your answers that need to be 8 added to, deleted or corrected in any way? 9 A. No. 10 Q. You'll have the opportunity to 11 read and review your deposition once the court 12 reporter types it up, and will be able to make 13 additions or deletions or anything that's either 14 mistyped or something that's misunderstood by you 15 or me, okay? 16 A. Thank you. 17 Q. I would like to ask you, 18 first, while we're on the record, there was some 19 question yesterday about one of the names that 20 was deleted as to whether or not that individual 21 was a pivotal investigator or not, and there was 22 going to be some examination made as to whether 23 or not that individual was a pivotal 24 investigator. Page 251 1 MR. LORE: Because of the lateness of 2 the hour when we left, we were unable to contact 3 anybody that would help us with an answer to that 4 question. So right now we still don't know. 5 We'll check as soon as we can. 6 Q. Let me ask you in connection 7 with -- in connection with Exhibit 2, as I 8 understand it, Doctor Slater, these are portions 9 of your personal diary, is that correct? 10 A. Yes. 11 Q. And these were all notes made 12 by you. 13 A. Yes. 14 Q. And the diary that you kept 15 recorded your personal observations with respect 16 to not only Lilly matters, but personal matters, 17 is that right? 18 A. Yes. 19 Q. And the diary that you kept 20 was not directed to be kept by Lilly, is that 21 right? 22 A. Yes. 23 Q. And you did this on your own. 24 A. Yes. Page 252 1 Q. And these were your personal 2 notes for your personal use, is that correct? 3 A. Yes. 4 Q. They're not Lilly's property 5 at all, they're your property, aren't they? 6 A. That's my understanding. 7 Q. Well, you took your diary with 8 you when you left, didn't you? 9 A. Yes. 10 Q. And you felt that the reason 11 you could take that with you is because it was 12 yours, it wasn't Lilly's. 13 A. Yes. 14 Q. Is that right? 15 A. Uh-huh. 16 Q. Is that a yes? 17 A. Yes. 18 Q. And before you left, you did 19 not submit these notes in this diary to Lilly to 20 review, did you? 21 A. No. 22 Q. These various pages that have 23 black marks on them have people's names and 24 locations marked out. You didn't mark those out, Page 253 1 did you? 2 A. No. 3 Q. You gave those to the Lilly 4 attorneys and they did that. 5 A. Yes. 6 Q. And they marked those names 7 out some thirteen years -- fourteen years after 8 you left, correct? 9 A. Yes. 10 Q. You left December 31st, 1979, 11 and today is January 29th or 30th? 12 MR. ARMSTRONG: 29th. 13 Q. 1994, correct? 14 A. That's true. 15 Q. Nobody from Lilly looked at 16 these documents until you were subpoenaed in 17 connection with this matter, did they? 18 A. That's not so. 19 Q. When did you first turn over 20 this diary to anybody from Lilly for their 21 review? 22 A. In about 1976, the FDA had 23 sent representatives to Lilly to check on an 24 Aprineine, A-P-R-I-N-E-I-N-E, study that had been Page 254 1 done by Lilly, and investigators from the FDA 2 reviewed the pertinent sections of the diary 3 pertinent to the Aprineine matter. In about 4 1984, the attorneys for a former Lilly employee 5 named James Campbell, who was suing the company 6 for various personal problems, also reviewed the 7 diary in a selective manner and made -- I don't 8 know if he made copies or not. 9 Q. But on those occasions, there 10 was nothing deleted by either the FDA or Lilly in 11 that diary as has the deletions been in Exhibit 12 2, is that correct? 13 A. Not to my knowledge. 14 MR. ARMSTRONG: Excuse me, Counsel. 15 When you're referring to deletions, are you 16 referring to the blacked out numbers and names or 17 are you referring to the redactions that were in 18 the -- or both? 19 MR. SMITH: I guess both, because 20 there have been, as I understand it, in the 21 previous testimony yesterday, there are some 22 areas where names have been blacked out, and 23 there were other areas where like I know there 24 was one page where an amount of money paid to a Page 255 1 particular investigator was redacted by virtue of 2 a blank piece of paper put over the document and 3 then it was copied, correct? 4 A. It was the amount of money 5 that the investigator was asking for, not the 6 amount of money that was paid. 7 Q. But the point is is that that 8 was done by an attorney for Eli Lilly after you 9 were subpoenaed by the plaintiffs in these cases. 10 A. Yes. 11 MR. ARMSTRONG: That being the blacked 12 out portion, is that what you're referring to? 13 MR. SMITH: The blacked out portion 14 and, I think, one instance where there was a copy 15 made and an amount of money was eliminated. 16 MS. MORTIMER: And I believe there are 17 entries in this thing as well. 18 MR. ARMSTRONG: So we can make it 19 clear, the portions of the diary which appear in 20 Exhibit 2, the written portions, are those 21 portions which the doctor at first, and then I, 22 after reviewing the diary in toto, agreed were 23 responsive to the subpoena. And also, there was 24 an effort made in my office to redact out the Page 256 1 dollar amounts, it being my understanding that 2 there had been a court order which directed that 3 expenses paid to people for these studies were 4 not discoverable, so we made that effort. I must 5 confess, as we saw it yesterday, we missed a 6 couple. I think that covers what has been done. 7 Do you agree with that, Doctor? 8 THE WITNESS:: Yes, I think that 9 everything that is in the diary that could 10 possibly be of interest to you in relation to 11 Fluoxetine appears in this exhibit. 12 Q. But my question is: 13 Everything that was done in connection with 14 preparing this document that we see as Exhibit 2 15 was done by either your lawyer that Lilly 16 suggested to you, or by Lilly lawyers after you 17 had received the subpoena? 18 A. Yes. 19 Q. And these were your personal 20 records that you turned over to either your 21 lawyer or the Lilly lawyer? 22 MR. ARMSTRONG: Objection, asked and 23 answered. Whoever had ten minutes wins. 24 Q. Is that right? Page 257 1 A. Yes. 2 Q. At this time, Counsel, it's 3 our position that the orders in place in this 4 case pertain only to Lilly documents, and that 5 this is not a Lilly document, and that this is 6 Doctor Slater's personal document, and that this 7 constitutes research independent from -- or 8 discovery independent from sources other than the 9 corporate defendants, and we at this time would 10 request a copy of Exhibit 2 without any deletions 11 with respect to Fluoxetine matters. Now to be 12 clear, we are not requesting any personal 13 information with respect to any work done on 14 drugs other than Fluoxetine, but it's our 15 position here that this document is not covered 16 at all by the discovery order. 17 MR. ARMSTRONG: My understanding is 18 otherwise, my understanding is that there is an 19 order which effects and controls the extent of 20 the discovery to which you're entitled, from 21 whatever source. And, therefore, I will stand on 22 what was done. 23 MR. LORE: Lilly joins in the 24 objection, and furthermore says that although Page 258 1 these were Doctor Slater's personal notes, these 2 notes were made concerning work that he was doing 3 for Lilly when he was employed for Lilly, and 4 therefore we'll take the position that these 5 notes would be covered by any orders of the 6 court. 7 MS. MORTIMER: Obviously the position 8 that Paul submitted in this case is taken by the 9 plaintiffs' attorney and plaintiffs in the 10 Fentress case. 11 THE WITNESS: Is it relevant that all 12 the notes were made on my desk that was paid for 13 by Eli Lilly and copy? 14 MR. ARMSTRONG: Yes, I think it is, 15 Doctor. 16 Q. I believe we were on -- 17 MR. SMITH: I assume that counsel is 18 going to refuse at this time to -- 19 MR. ARMSTRONG: Right. 20 MR. SMITH: -- comply with my request? 21 MR. ARMSTRONG: Right. 22 MS. MORTIMER: For the record, we'll 23 reserve the right to call Doctor Slater back 24 after the court's ruling on this case and Page 259 1 redepose him on issues with respect to the diary. 2 And, also, while I'm on the record, the issue as 3 to the name of the individual that was redacted, 4 and it's questionable whether the need for the 5 redaction was justified. 6 Q. All right. Let's turn to 7 page, I believe we're on, forty-six? 8 MR. ARMSTRONG: Yes. 9 A. I'm pleased to see that we're 10 near the bottom of the pile. 11 Q. We have some more piles that 12 we're going to show you in a little while, so 13 don't get overly optimistic, Doctor Slater. Are 14 you at page forty-six? 15 A. Yes. 16 Q. Let me ask you this before we 17 get specifically into this: With respect to your 18 knowledge concerning uses of Fluoxetine, was 19 there ever, according to your knowledge, an 20 original design or intent to use Fluoxetine and 21 promote Fluoxetine as an antiobesity agent as 22 opposed to an antidepressant? 23 A. I think you better clarify the 24 question. Page 260 1 Q. Well, we've seen in this 2 document, Exhibit 2, and other documents, the 3 issue as to whether or not Fluoxetine would be 4 beneficial for use as an antiobesity agent, 5 correct? 6 A. Yes. 7 Q. My question is: Originally, 8 after Doctor Molloy, Fuller and Wong developed 9 this drug, were there thoughts that the drug 10 should originally be used as an antiobesity agent 11 as opposed to an antidepressant? 12 A. No, the primary intent was -- 13 or hope was that it would be effective as an 14 antidepressant. Doctor Fuller particularly was 15 interested in the question of whether the 16 serotonin energy mechanisms were related to the 17 control of appetite, and the possibility that in 18 addition it might have appetite suppressant 19 properties. 20 Q. Was Doctor Fuller of this 21 opinion before Fluoxetine was actually 22 synthesized in his research in connection with 23 the serotonin system or was this something that 24 he came up with after Fluoxetine? Page 261 1 A. You would have to ask Doctor 2 Fuller. 3 Q. You just don't know. 4 A. I'm not sufficiently sure to 5 put it in official testimony. 6 Q. As far as you know, though, 7 the original intent was to develop Fluoxetine for 8 its antidepressant properties? 9 A. Yes. 10 Q. I'm not sure that we've read 11 the 6-29-79 entry in its entirety. Can you read 12 that for me, please? 13 A. I think I read it twice, but 14 I'll do it a third time. Doctor Fabre has agreed 15 to a double-blind trial, but another physician, 16 whose name is blanked out, wants a little more 17 experience, and wants to go with Imipramine. 18 This is Thomas -- somebody whose name was blanked 19 out -- was to have sent us protocols, but nothing 20 came. Called to make an appointment in 21 Nashville, and then somebody else blanked out. 22 Will be ready in October or November. Will also 23 try -- two other names that are blanked out then. 24 Q. With respect to these other Page 262 1 names that are blacked out, are these other 2 physicians that were going to do protocols or 3 interviewed for protocols in connection with 4 Fluoxetine? 5 A. These are all people who had 6 experience in the testing of antidepressant 7 agents, and who could be considered candidates 8 for, what shall we say, research projects related 9 to Fluoxetine. 10 Q. Do you know whether or not any 11 of these individuals did protocols in connection 12 with Fluoxetine? 13 A. Since the names are blanked 14 out, right now I'll have to say no, but I suspect 15 the answer is some did and some didn't. 16 MR. ARMSTRONG: We would like to show 17 the doctor that this name -- the three names that 18 appear in the last two lines of the entry, he can 19 disclose to you. 20 A. Next to the last line, it 21 should read Bremner, B-R-E-M-N-E-R, will be ready 22 in October or November. Will also try Masco, 23 M-A-S-C-O, and Denver, D-E-N-V-E-R, then. 24 Q. Bremner is -- what's his first Page 263 1 name? 2 A. I have no recollection. 3 Perhaps somebody else does, I don't. 4 Q. Who were the other two names, 5 Masco -- 6 A. Masco and Denver. 7 Q. What's Denver's first name? 8 A. I've always called him Hy, 9 H-Y, and I don't know what his full name is. 10 Q. And I believe you told us 11 yesterday where he lived? 12 A. I told you that fifteen years 13 ago I had an address, I think, in Spring Valley, 14 New York, but this is not something I would 15 recommend anybody rely on. Surely if you really 16 wanted to talk to Doctor Denver, first you best 17 determine whether he's still alive, and second, 18 where he might be. But Doctor Denver, as far as 19 I know, never did any clinical trial, and would 20 only be able to give you testimony about the fact 21 that he and I were interns together some fifty 22 years ago, and that we had met a couple -- at the 23 meeting in Key Biscayne, and we had discussed his 24 experience with antidepressant agents. The fact Page 264 1 that Doctor Masco was a student of his, and so -- 2 but I don't think he has anything in the way of 3 personal experience with clinical trials. 4 Q. Did you go to Nashville? 5 A. Yes. 6 Q. Who did you meet with in 7 Nashville? 8 A. I met with Doctor Fridloin, 9 F-R-I-D-L-O-I-N, and Doctor Sulser, S-U-L-S-E-R. 10 I don't think he ever became an investigator. 11 Q. Was he at a hospital or was he 12 in private practice? 13 A. He was in a hospital and 14 associated with the University, Vanderbilt. 15 Q. And did he decline to do a 16 study for you? 17 A. I think -- my recollection 18 goes like this: That Mrs. Slater and I were 19 driving down to Florida, and we drove off the 20 road to a -- may have been a V.A. hospital or 21 something like that. I talked with Doctor Sulser 22 for about a half an hour, and he said he might be 23 interested. And as far as I know, nothing ever 24 came of it. Page 265 1 Q. You don't know that he sent a 2 C.V. or proposal to Lilly, and you don't have any -- 3 A. I have no recollection of 4 anything ever coming of this meeting. I figured 5 I wasted a couple of hours of my time, my life. 6 Q. Did he have any opinion 7 concerning the serotonin system and its 8 relationship to -- 9 A. Yes, he had a very elaborate 10 theory which he published in the science magazine 11 about this time, but it would be a, what shall I 12 say -- it would imply that my memory is better 13 than it really is if I were to try -- it would be 14 presumptious of me to try to outline his theory 15 to you now. 16 Q. Can you give us any general 17 idea? 18 A. No, I would rather not, 19 because it's not relevant because I think it was 20 not so. 21 Q. Do you recall where that 22 matter was published, what journal? 23 A. My recollection was it was 24 published in Science. Page 266 1 Q. The publication called 2 Science? 3 A. Yes. That also could be 4 wrong. 5 Q. Let's go to page forty-seven, 6 the note of 7-13-79. 7 A. I should say that my visit to 8 Doctor Sulser is not contemporaneous with the 9 dates that we're dealing with now. You asked me 10 if I had been to Nashville, it wasn't at this 11 particular time. 12 Q. I believe it says the notation 13 of 6-29-79, and you said call to make an 14 appointment in Nashville. So obviously you went 15 sometime after June 29th, is that correct? 16 A. I can't say exactly when I 17 went to Nashville. My recollection is it was in 18 the Fall rather than in the Summer. 19 Q. Read the July 13th, 1979 20 entry. 21 A. Can we reveal the names here? 22 Friday, Doctor so and so, who is so and so's 23 associate, at such and such place, called to tell 24 me that a twenty-six year old female who has been Page 267 1 on Fluoxetine has a falling white blood count of 2 four point one, four three point nine three point 3 three, which is a normal differential. 4 Hematacrit dropped from forty-one to thirty-three 5 with zero point three percent reticulocytes. 6 Platelets, two hundred twenty-five thousand. 7 Hematologic consult this afternoon. 8 Q. All right. Go ahead. 9 A. I had been planning to visit 10 so and so, and possibly so and so, during the 11 week of August 6th, but I guess I'll wait before 12 I buy a ticket. 13 Q. Now does the second paragraph 14 of that notation have anything to do with the 15 first paragraph of the notation? 16 A. I would have to check the 17 copies and see if the names are available. 18 MS. MORTIMER: Doctor, when you do 19 this, you're refreshing your recollection in 20 looking at the names that have been redacted, is 21 that correct? 22 THE WITNESS: Pardon? 23 MS. MORTIMER: When you are looking at 24 the names that have been redacted, such as you Page 268 1 are now, you're refreshing your recollection as 2 to occurrences that happened during that time, 3 correct? 4 THE WITNESS: Yes -- no. 5 Q. No what? 6 A. The two paragraphs are not 7 connected. 8 Q. Let's talk about the first 9 paragraph, then. You had received a report from 10 someone apparently concerning a woman who had 11 been given Fluoxetine, is that right? 12 A. Yes. 13 Q. And I would assume, by virtue 14 of the fact that this was in 1979, that that 15 woman would have had to have been part of a 16 clinical trial with respect to Fluoxetine? 17 A. Yes. 18 Q. And would that have been a 19 depression clinical trial? 20 A. It was not. 21 Q. For what other purpose were 22 you conducting clinical trials at that time? 23 A. As I mentioned, there's a 24 neuromuscular disorder that this particular Page 269 1 physician was particularly interested in, had the 2 feeling that serotonin helped such patients and 3 that such patients were helped even more if given 4 L-5 Hydroxy-tryptophan. And he wanted to add on 5 the Fluoxetine to further enhance the effect on 6 this neuromuscular disorder. 7 Q. Did you do anything else in 8 connection with this entry, I mean did you do any 9 further investigation concerning these abnormal 10 values? 11 A. I visited him on the 20th -- 12 Q. All right. 13 A. -- on the 18th. And I learned 14 what is in the next note. 15 Q. Before we get to that next 16 note, what does the middle paragraph have to do 17 with in connection with Fluoxetine, where you 18 said you had been planning to visit somewhere 19 during the week of August? 20 A. These were other investigators 21 that -- it includes Doctor Bremner's name, and 22 one in -- and Doctor Masco, and a third man whose 23 name was deleted correctly because I don't think 24 he became an investigator during the time that I Page 270 1 was involved with the project. 2 Q. Well, if he wasn't an 3 investigator, then it's our position that that's 4 something that we are entitled to under the 5 order. 6 A. I'm not sure that he didn't 7 become an investigator later, so I can't -- 8 MS. HUFF: That's one of them we're 9 checking. 10 A. I can't understand -- 11 MS. HUFF: We're checking all those 12 that are not pivotal. 13 Q. The problem, then, is if 14 that's not an investigator and he didn't do any 15 studies, then our judgment is that that name 16 would be discoverable. 17 MS. HUFF: We understand. 18 MR. SMITH: If we have to bring him 19 back because we didn't get the information today, 20 then that's just another reason why we're going 21 to have to continue. 22 A. May I make a comment? I went 23 to medical school, and not law school, and so I 24 don't really understand what's going on. What Page 271 1 possible interest can you have in the name of a 2 man with whom I spoke who never became involved 3 with the Fluoxetine, and has nothing to do with 4 the clinical trials, what difference does it make 5 to you who he was? Suppose I told you it was Joe 6 Smith, and he turned out to be your distant 7 cousin, would you race out to see Joe? 8 Q. Most of my cousins aren't even 9 speaking to me. 10 A. I can understand why. 11 Q. It doesn't come as a surprise 12 to you, does it? 13 This is -- I don't have to 14 give you a response, Doctor Slater, but I will 15 explain to you this is a discovery deposition. 16 We obviously don't know whether or not this would 17 lead us to discoverable evidence or not, but the 18 law requires -- or allows us to get discovery in 19 these cases. The question is how far do we go, 20 and that's the reason for some of these court 21 orders. 22 A. In concert with your visits to 23 that city in the far west, I would like to lay a 24 wager that this man will not give you any Page 272 1 information at considerable odds. 2 Q. I'm probably not going to take 3 that bet. All right, let's move on to the entry 4 of July 20th. It says there that you visited -- 5 and I assume that's the name of the individual? 6 A. Yes, the man referred to in 7 the first paragraph. 8 Q. On 7-18, patient's mother 9 sometimes gives patient -- is that Macrodantin? 10 A. Yes. 11 Q. We couldn't be sure. If I 12 don't read this correctly, stop me, okay, Doctor. 13 Her marrow on 7-13 was recovering, count is 14 rising slowly. Neither -- and I assume that's 15 the same doctor that's marked out on the first 16 line of the 7-20 notation? 17 A. No. 18 Q. It's another doctor. 19 A. Another doctor who was -- we 20 told the people who were doing investigations 21 about this so that they would be fully informed 22 and know as much as we knew at that time about 23 this particular thing. And both of these 24 investigators were not concerned that this drop Page 273 1 in white count should in any way influence their 2 studies. 3 Q. So -- 4 A. In other words we were making 5 a disclosure to our investigators of what could 6 have been a source of some concern. 7 Q. It says neither blank nor 8 Fabre seemed concerned. Will meet with project 9 team on Monday, 7-23. I'm not entirely 10 comfortable, and I do suspect this was Fluoxetine 11 related. Fabre says he is hearing about 12 increased pain during menstruation. I thought we 13 had no young women, but he says there are -- 14 A. These are anovulatory or have 15 tubal ligation, and so on. 16 Q. Is that the end of that entry? 17 A. Uh-huh. 18 Q. Is that a yes? 19 A. Yes -- wait a minute, let me 20 turn the page and make sure. Yes. 21 Q. Now apparently you had called 22 Doctor Fabre and reported this problem to him. 23 A. Uh-huh. 24 Q. Is that a yes? Page 274 1 A. Yes. 2 Q. Had Doctor Fabre had some 3 experience with this? I'm wondering why you had 4 called him to get his input with respect to 5 whether or not the problem that this lady was 6 experiencing -- 7 A. I wasn't calling him to get 8 input, I was calling him to inform him about 9 something which could have been an undesirable 10 side effect and to tell him that this is, at the 11 moment, something which I was concerned about. I 12 think that, what is it, almost ten years of 13 experience now, and millions of patients, 14 indicate that Fluoxetine does not ordinarily 15 cause blood dysplasia, and so our concern was 16 justifiable, but not supported by later facts. 17 Q. At that time was Doctor Fabre 18 doing a study? 19 A. I can't answer that in detail, 20 I really don't remember the timing that closely. 21 And he -- I don't know how he could report that 22 there was an increase of pain in menstruation 23 unless he had been treating patients because I 24 don't think he menstruates. Page 275 1 Q. Well, we know he had done a 2 part of a single-blind study, and that you had 3 agreed to let him do a double-blind study, is 4 that right? 5 A. Uh-huh. 6 Q. By virtue of your previous 7 notations in your diary, correct? 8 A. Yes. 9 Q. And there apparently was some 10 protocols that excluded women or you had some 11 idea that there were no women in the studies by 12 virtue of your statement I thought we had no 13 young women. Is that correct? 14 A. Yes, young women. 15 Q. So does that indicate to you 16 that he was indeed doing a study at that time? 17 A. Yes. 18 Q. And he told you in July of 19 1979 that he was hearing about increased pain 20 during menstruation, correct? 21 A. That's what it says. 22 Q. Did he indicate that he was 23 hearing this from his patient or maybe other 24 investigators who had -- Page 276 1 A. There weren't that many other 2 investigators, and he had no contact with any of 3 them. 4 Q. So it was your impression that 5 he was hearing this from his patients? 6 A. Yes. 7 Q. And he wasn't treating any 8 patients with Fluoxetine outside the clinical 9 trials at this time, was he? 10 A. Not to my knowledge. 11 Q. Let's go to page forty-eight, 12 the 8-9-79 notation. It says visited blank -- 13 A. In Nashville. I don't 14 remember that visit, I'm sorry. 15 Q. Who was that in Nashville that 16 you visited? 17 A. This was one of the 18 non-investigators whose name I think is still 19 under privilege. 20 Q. Is that Doctor Sulser? 21 A. No. 22 Q. And then there's two blanks 23 --three blanks on the second line. 24 A. That says Doctor Masco in New Page 277 1 Port Richey. 2 Q. All right. Then there's 3 another blank where it says says -- 4 A. Oh, no, the visited blank in 5 blank is the name of a city, and then the next 6 line is where it says Masco in New Port Richey. 7 Q. But is it Masco that says that 8 he can run a twenty, forty, sixty, eighty 9 milligram Fluoxetine study? 10 A. Yes. 11 Q. But four sets of patients 12 started in October of 1979 -- 13 A. Oh, I did it wrong. Then the 14 blank says he can run a twenty, forty, sixty, 15 eighty Fluoxetine study. This is the 16 investigator who is blanked out in the first 17 line. 18 Q. That's not Masco? 19 A. No. 20 Q. That's some other 21 investigator. 22 A. Yes. 23 Q. Did he do -- that gentleman 24 whose name is blanked out, did he do studies? Page 278 1 A. Not to my recollection. 2 Q. If he didn't do any studies, 3 then we would request that you give us the name 4 of that gentleman. 5 MR. LORE: Again, Paul, as I said 6 yesterday, Doctor Slater had limited experience 7 or limited knowledge of what went on after he 8 left the company, and it's very possible, and in 9 some cases very likely, that the person marked 10 out in fact did a study for Lilly later that 11 turned out to be a nonpivotal study. So we'll 12 check on that. We tried to check last night, as 13 I told you, but at 5:30 on Friday, there was 14 nobody to check with. 15 MR. SMITH: The point is you have had 16 the journal for weeks. 17 MR. LORE: Paul, I got a copy of this 18 journal yesterday when you got your copy. I got 19 a copy of this yesterday when you did, I think 20 that could be confirmed by Doctor Slater's 21 lawyer, Mister Armstrong, and the blacked out 22 names were in fact done yesterday after we got 23 this. 24 MS. MORTIMER: By you and Ms. Huff, Page 279 1 correct? 2 MR. LORE: By Lilly's attorneys. 3 THE WITNESS: Well, I can confirm this 4 in the following way: I got your subpoena, I 5 notified Mister Lore, and he suggested that I 6 mail the diary to Mister Armstrong, which I did. 7 Having spent a good deal of time reading it and 8 preparing notes to guide him, then he had the 9 diary over the weekend, and the people from Lilly 10 have not had an opportunity to see the diary. 11 Q. As far as you know? 12 A. Well, it would be kind of 13 imaginative if they could get to Miami or see 14 from either -- 15 MR. ARMSTRONG: As far as I know, 16 people from Lilly have not seen the diary, at 17 least have not seen it since the diaries were 18 sent to me. 19 MR. SMITH: Well, I received telephone -- 20 I had a telephone conversation with Larry Myers, 21 with Eli Lilly and Company, the first part of 22 this week asking me -- advising me that a diary 23 did exist, and that there were going to be some 24 deletions made, and asking me if it would be Page 280 1 necessary to file a protective order. And I 2 advised at that time it would not be necessary to 3 file a protective order. Then Mister Armstrong, 4 I believe, followed up with correspondence 5 indicating that a protective order -- that you 6 had the diary, that you had reviewed the diary, 7 that you were not going to produce all the diary, 8 that there had been material deleted from the 9 diary. So my point is that either Lilly or 10 Lilly's agents or attorneys with Lilly have had 11 the diary or had access to the diary for some 12 time, at least a week, to review this. 13 THE WITNESS: I think you're confused. 14 MR. ARMSTRONG: I want to get it 15 clear. After the doctor sent the diaries to me, 16 which I think was last week, I read the diary 17 independently, and supplemented references which 18 I thought were relevant and covered by the 19 subpoena, and expanded, therefore, the 20 information which had been marked by Doctor 21 Slater in his note to me about the diary. I 22 brought the diaries to Doctor Slater, and we went 23 over the diaries. The Lilly counsel were with us 24 at the time Doctor Slater and I went over the Page 281 1 diaries, and -- 2 MR. SMITH: Excuse me, I didn't mean 3 to interrupt you, but when was that that the 4 Lilly counsel was with you? 5 MR. ARMSTRONG: That was last week, I 6 guess, late -- Monday -- Monday of this week. 7 MR. SMITH: All right. 8 MR. ARMSTRONG: I then took the 9 diaries to my office and had the changes made, 10 the redactions made that you have before you, and 11 when we came here, I passed out those copies. We 12 then realized, or Lilly counsel then realized 13 that there were other orders which covered the 14 materials which I had given to you, and as they 15 sat on this desk for the first half session until 16 the lunch break yesterday, realizing that, we 17 collected the copies and Lilly's counsel made the 18 blacked out redactions, which you see, which are 19 intended to take out the names of the 20 investigators and take out the dollars. That's 21 my understanding. 22 MR. SMITH: But Lilly's counsel saw 23 this document as early as Monday. 24 MR. ARMSTRONG: They saw it when I was Page 282 1 going over it with the doctor. 2 MR. SMITH: Which was Monday the 24th? 3 MR. LORE: I have to correct you. We 4 did not see the diary at the time, as you recall, 5 you and Doctor Slater were reading it. 6 MR. ARMSTRONG: Yes, I knew that. 7 What we were doing, we were going over it, the 8 doctor and I were going over it. 9 MR. SMITH: Whatever, when you were 10 going over it, Lilly's counsel was present. 11 MR. ARMSTRONG: They were present, 12 they were not -- they were across the room, and 13 we were discussing such things as whether or not 14 the Fluoxetine was covered by other compound 15 numbers. That's what the doctor and I were 16 talking about. Not covered by, but related to. 17 MR. SMITH: It's our position that 18 Lilly's counsel has had an opportunity to review 19 this and make the determinations that they say 20 they've not been able to do at this point, we 21 simply make that observation and statement for 22 the record. 23 MR. LORE: And I will make a statement 24 and state that yesterday was the first day that I Page 283 1 had seen these written entries that Doctor Slater 2 had made, that we purposely have not looked at 3 his diary because it does contain information 4 that we should not be privy to, his personal 5 matters. 6 MR. SMITH: Because this is his 7 personal diary, correct? 8 MR. LORE: I've already said it's his 9 personal diary. But the entries that had been 10 given to you were made at the time that he was 11 employed by Lilly, and in fact he commented that 12 he made the diary on a desk provided by Lilly, 13 and he also probably used a Lilly pen to do the 14 entries. 15 THE WITNESS: No, no, I used my own 16 pen that was given to me by my wife in 1950. 17 MR. LORE: But you left that pen at 18 home one day, I bet. 19 THE WITNESS: All the rest were with 20 the same pen that I have been using for forty 21 years or fifty years. 22 Q. Whoever it was, says that he 23 can run a twenty, forty, sixty, eighty milligram 24 of Fluoxetine study, but four sets of patients Page 284 1 started in October of 1979 were taken to July, 2 1980 for completion. I expressed concern that 3 four subjects of each dose might not be 4 sufficient, correct, am I reading that correctly, 5 Doctor? 6 A. Yes. 7 Q. He seems confident that we 8 would get answers, correct? 9 A. Right. Could be. 10 Q. Could be is the next notation, 11 right, is that correct? 12 A. Yes. 13 Q. Then you say we know that 14 twenty rarely works, and that sixty causes lots 15 of agitation, so I am going to recommend that we 16 go ahead and support the project. Correct? 17 A. Yes. 18 Q. What data did you have in 19 August of 1979 that indicated, Doctor Slater, 20 that twenty milligrams rarely works? 21 A. I really don't remember. 22 Q. You had some data and some 23 scientific basis at the time for making that 24 notation, did you not? Page 285 1 A. Yes. 2 Q. What data did you have, Doctor 3 Slater, in August of 1979 that sixty milligrams 4 of Fluoxetine, Prozac, causes a lot of agitation? 5 A. I don't remember. 6 Q. There was scientific data, 7 though, available to you that caused you to make 8 that notation that sixty milligrams caused 9 agitation, correct? 10 A. Yes. It should mention that 11 there have been a lot more detailed clinical 12 studies that followed this. 13 MR. SMITH: We object to the response 14 as being nonresponsive to the question as asked. 15 Q. Let's continue reading. 16 Somebody marked out seems like a sensible guy. 17 A. Masco. 18 Q. Masco seems like a sensible 19 guy, is that right? 20 A. Uh-huh. 21 Q. That's what it reads. His 22 associate, Mister -- and who was his associate? 23 MR. ARMSTRONG: We have to check on 24 that. Page 286 1 A. This was a young physician's 2 associate, his name was Sheets. 3 Q. Sheets? 4 A. Uh-huh, S-H-E-E-T-S. 5 Q. Do you know his first name? 6 A. No. 7 Q. Mister Sheets seemed aware of 8 which side is up. Is that your notation? 9 A. Yes. 10 Q. Why did you make that 11 notation, Doctor? 12 A. Because I was impressed that 13 Doctor Masco's facility probably would give us 14 reliable data, that his physician, associate 15 seemed to be a knowledgable and sensible young 16 man. 17 Q. Your terminology of seemed 18 aware of which side is up, correct? 19 A. What I'm saying is that he 20 seemed like a bright young guy, and 21 conscientious. 22 Q. My question is: Why did you 23 use the term he's aware of which side is up? 24 MR. ARMSTRONG: Asked and answered, Page 287 1 twice now, already. 2 A. He seemed like a bright guy 3 who would do a competent job. In other words he 4 was not a confused individual who didn't know 5 what was going on in the world. 6 Q. You make a notation that he's 7 a bright guy and seems to know which side is up. 8 Had you had problems with some investigators or 9 some investigators' assistants that didn't seem 10 to be bright or know which side was up? 11 A. Not that I recall. I was just 12 impressed with this facility, that it seemed like 13 a good place to site a study. 14 Q. Let's continue reading. It 15 says that somebody's suggestion. And whose 16 suggestion, was that Masco? 17 A. Doctor Masco suggested that I 18 call another company for whom he had done some 19 research. 20 Q. Wait a second. At Masco's 21 suggestion I called -- and you say the next name 22 that's blacked out is another pharmaceutical 23 company? 24 A. Yes. Page 288 1 Q. What pharmaceutical company is 2 that? 3 A. Robbins. 4 Q. Then it should read at Masco's 5 suggestion I called Robbins and found that -- 6 A. Bill Fenderburg. 7 Q. Bill Fenderburg had died. 8 Then it says Doctor -- and who is blanked out 9 there? 10 MR. ARMSTRONG: You can't give him 11 that. 12 MR. SMITH: Let the record reflect 13 that in-house counsel for Lilly is advising 14 Doctor Slater's attorney to, quote, object to 15 that, end quote. 16 MR. ARMSTRONG: No, not object to it, 17 but just not unmask it, it stays masked. 18 A. Somebody at the Robbins 19 Company called today and gave Masco good marks. 20 Q. So the doctor -- where it says 21 doctor, and then there's two blanks marked out, 22 is a doctor at the Robbins Company? 23 A. Yes. 24 Q. Then I call on counsel to Page 289 1 advise me of the name of the doctor at the 2 Robbins Company. 3 MR. ARMSTRONG: Is this a doctor from 4 the Robbins Company? 5 THE WITNESS: Yes. 6 MR. ARMSTRONG: Then give him the 7 name. 8 A. It says Bill Taber, T-A-B-E-R. 9 Q. So Doctor Bill Taber called 10 today and gave who? 11 A. Doctor Masco good marks. 12 Q. Who is the next name that's 13 blocked out there? 14 A. Masco. 15 Q. Masco wanted to know whether 16 Lilly would pay for hospitalization should a drug 17 reaction occur, correct? 18 A. Yes. 19 Q. And you called and says I 20 called him to say that Bendush will stand behind 21 the physician, et cetera. He mentioned that 22 Lilly has his C.V. since he had applied for a 23 job. We will check. And I don't know what that 24 next word is. Page 290 1 A. Could. 2 Q. Could be a good guy for the 3 job, correct? 4 A. Yes, and this is a little 5 confusing. I think the first job was that when -- 6 before Doctor Masco had gone into private 7 practice, he had considered applying for a job as 8 a research physician at Eli Lilly and Company. I 9 don't remember checking to see his application. 10 Then the second said could be a good guy for the 11 job. This refers to setting up a clinical trial 12 for Fluoxetine. 13 Q. With Masco? 14 A. With Masco. 15 MR. SMITH: Let's take a break here. 16 (A SHORT RECESS WAS TAKEN.) 17 Q. Back to page forty-nine of 18 Exhibit 2, Doctor Slater, and I believe we 19 developed this is -- Masco wanted to know whether 20 Lilly would pay for hospitalization should a drug 21 reaction occur, is that correct? 22 A. Yes. 23 Q. And you said I called him to 24 say that Bendush will stand behind the physician, Page 291 1 et cetera, is that correct? 2 A. Yes. 3 Q. By that, did you mean to 4 indicate that it was Lilly's policy at that time 5 to pay for a hospitalization if an adverse drug 6 reaction occurred? 7 A. I think so. 8 Q. You say that Bendush will 9 stand -- 10 A. It's Bendush, B-E-N-D-U-S-H. 11 Q. I'm sorry, Bendush will stand 12 behind the physician. Had there been any claims 13 made against a physician in connection with the 14 clinical trials concerning Fluoxetine up to that 15 point? 16 A. Not to my knowledge. 17 Q. Let's go to page fifty, your 18 8-17-79 notation. Would you read that, please? 19 A. The Fabre double-blind against 20 placebo is ready to go if again is approved. 21 This patient one oh three has some corneal and 22 conjunctival lesions as well as hilar infiltrates 23 that Fabre says are probably viral in origin. 24 Will know more when he sees the patient again on Page 292 1 August 20. 2 Q. Did you participate in doing 3 the protocol for the double-blind against placebo 4 protocol? 5 A. Probably. 6 Q. Or for the double-blind 7 against placebo study? 8 A. Probably. It may surprise you 9 to understand that I don't have a good 10 recollection of something that happened fifteen 11 years ago. 12 Q. Let's go to the 8-21-79 13 notation. 14 A. Yes. 15 Q. The first name is blacked out. 16 Who is that? 17 A. This is not a key 18 investigator. 19 MR. ARMSTRONG: Just leave it blank, 20 Doctor. 21 A. A physician called to tell us 22 that he had taken both of his -- oh, no, a 23 secretary called to tell us that a physician had 24 taken both his patients off Fluoxetine, and one Page 293 1 was a young man with suicidal risk and 2 increasingly thought disorder that probably 3 should be classified as schizophrenic or schizo 4 effective. He was started on Mellaril. The 5 other must be a simple failure. 6 Q. Let's stop right there. The 7 first line that's blacked out there is the name 8 of a secretary? 9 A. I think so. 10 Q. You have the original notes 11 there. Can you refer to the notes to tell me 12 whether or not the name that's blacked out there 13 is a secretary? 14 A. It's a person in an 15 administrative rather than in a research capacity 16 as far as I recall. 17 Q. All right. So the first name 18 that's blacked out there is an administrator of 19 some sort? 20 A. Uh-huh. 21 Q. Is that a yes? 22 A. Yes. 23 Q. With a physician, is that 24 right? Page 294 1 A. Yes. 2 Q. And the second name that's 3 blacked out there is the name of a physician? 4 A. Yes. 5 Q. Was that physician doing a 6 clinical study in connection with Fluoxetine? 7 A. This was the entire extent of 8 the clinical study that he did. 9 Q. I don't understand. 10 A. These two patients, as far as 11 I recall, are the only patients he ever treated 12 with the drug. Now I can't make any comments of 13 what happened after 1980, but I know that by the 14 time I had retired, this was all he had ever 15 done, and I think it was just a matter of a few 16 days of each patient on medication. 17 Q. So you had this one physician. 18 And where was he located? 19 A. At a hospital. 20 Q. Where? 21 A. I don't think I'm supposed to 22 tell you. 23 MR. LORE: We object to that as being 24 identifying information as to who this nonpivotal Page 295 1 investigator would be. 2 MS. MORTIMER: We just want the record 3 to reflect that the witness' counsel for Lilly 4 nods their head up and down affirmatively or back 5 and forth negatively and is advised by counsel. 6 MR. ARMSTRONG: Let the record show 7 what happened, and that's not what happened. I 8 think that's a mischaracterization of the record. 9 We are operating under a court order which has 10 indicated that certain names do not need to be 11 disclosed. And to give the name or the location 12 of the otherwise undisclosed person is in my 13 view, and I'm sure that's why you asked the 14 question, Counselor, in effect disclosing the 15 name of the person, and therefore violative of 16 the order. And we're going to direct the witness 17 and he's going to perform accordingly. 18 MR. LORE: And Lilly joins in that 19 objection. 20 Q. Well, is this physician a 21 physician who only treated two patients with 22 Fluoxetine? 23 A. As far as I can recall. 24 Q. Well, did he ever -- did these Page 296 1 two patients ever become a part of a clinical 2 trial in connection with Fluoxetine? 3 A. My understanding was this was -- 4 his intent was to begin a clinical trial, he 5 treated these patients for a very short time, and 6 took both patients off the drug and never did 7 anything more in the way of a clinical trial. 8 Q. So he never completed the 9 clinical trial? 10 A. Yes. 11 Q. And he was just supplied some 12 Fluoxetine by Eli Lilly and Company? 13 A. He was supposed to have done a 14 clinical trial, but he didn't. 15 Q. As far as you know, the 16 results of his studies with these two patients 17 was never included in a report of a clinical 18 trial? 19 A. Well, it would be -- the 20 results of these two trials were reported in the 21 proper way, but they were not part of a major 22 clinical trial. 23 Q. Were there case report forms 24 sent to this physician? Page 297 1 A. Yes. 2 Q. Were case report forms sent 3 back by this physician? 4 A. Yes. 5 Q. Did you see the case report 6 forms on these two patients? 7 A. I don't remember, but I don't 8 think so. 9 Q. How do you know that there 10 were case report forms received back on these two 11 patients then, Doctor Slater? 12 A. See, I mentioned this note to 13 Mister Lore, and he called the company and they 14 checked the company records, and these things 15 have indeed been reported. 16 Q. Oh, you and Mister Lore, the 17 Lilly lawyer, had talked about this particular 18 notation? 19 A. Yes. 20 Q. When did you all talk about 21 this notation? 22 A. I think it was Monday. 23 THE WITNESS:: Is that right, Steve? 24 MR. LORE: I believe it was. And to Page 298 1 make the record straight, I did not see the 2 entry, and Doctor Slater mentioned to me about 3 the fact of this, and I did check on it. And 4 that's all I'll say about it. 5 Q. Did you read Mister Lore this 6 entry that you had here Monday? 7 A. Yes, I thought it was somewhat -- 8 MR. LORE: I'm sorry, Doctor Slater, 9 he asked if you read me the entry or did you just 10 tell me about it. 11 MR. SMITH: Let me ask the questions. 12 MR. LORE: I'm just correcting 13 something to make it clear. 14 A. Repeat the question. 15 Q. Did you read this entry to 16 Mister Lore? 17 A. I don't remember. 18 Q. Did Mister Armstrong read this 19 entry to Mister Lore? 20 A. I don't know whether he 21 remembers or not, but he has to answer the 22 question. 23 Q. Was Mister Lore present when 24 this entry was discussed between you, Mister Lore -- Page 299 1 A. The entry was discussed, it 2 was being examined between me and Mister 3 Armstrong. 4 Q. But Mister Lore was present at 5 the time? 6 A. Mister Lore was present. 7 Q. Did you read the contents of 8 the entry? 9 A. I don't know whether we read 10 it verbatim or merely discussed the nature of the 11 problem. 12 Q. Monday was January 20th, was 13 it not? 14 A. 24th. 15 Q. 24th, all right. Monday was 16 January 24th. Today is January the 29th. 17 MR. ARMSTRONG: Still is. 18 Q. At that time you gave Mister 19 Lore the name of the secretary and the name of 20 the physician that's mentioned in this notation, 21 didn't you, Doctor? 22 A. Yes. 23 Q. So it's your testimony that at 24 that time, on Monday -- today is Saturday -- that Page 300 1 lawyers from Lilly reported to you that they 2 called back to Indianapolis and checked on this 3 doctor, correct? 4 A. Yes. 5 Q. And they reported to you that 6 their research indicated that case report forms 7 were received back from this doctor? 8 A. Yes. 9 Q. Did they send to you copies of 10 the case report forms on this particular 11 individual? 12 A. No. 13 Q. Or these two patients? 14 A. No. 15 Q. Did they report to you whether 16 or not this physician ever did any clinical 17 studies involving any other patients other than 18 these two patients? 19 A. No. 20 Q. Did they tell you whether or 21 not these two individuals had been reported as 22 early terminations from the clinical trials? 23 A. They just told me that they 24 had been reported. He did not tell me that the Page 301 1 reports had been in any way characterized. 2 Q. Did he tell you whether or not 3 FDA form 1639s had been filled out in connection 4 with these two patients? 5 A. No, not specifically. 6 Q. And specifically did he tell 7 you what type of report concerning your notation 8 of a young man with suicidal risk and increasing 9 thought disorders, what kind of report was made? 10 A. No, just the fact that a 11 report had been made. 12 Q. But to whom, you don't know 13 that? 14 A. To the FDA. 15 Q. They confirmed that a report 16 to the FDA had been made? 17 A. Yes. 18 Q. Did they tell you the date of 19 that report? 20 A. No. 21 Q. Did they advise whether or not 22 they had checked to see whether or not any 23 follow-up was made concerning this patient who 24 had a suicidal risk -- Page 302 1 A. No. 2 Q. -- and was having increasing 3 thought disorders? 4 A. No. 5 Q. Did you make any follow-up, 6 Doctor Slater? 7 A. No. I assumed that the 8 diagnosis indicated that this was not the sort of 9 patient who was supposed to be in the study, and 10 that he had only been on the drug for a very 11 short time, and that what happened was not drug 12 related. 13 Q. That was your assumption? 14 A. Yes. 15 Q. Because you made no 16 investigation and don't know of anybody at Lilly 17 that did make an investigation concerning whether 18 or not these problems with this patient were drug 19 related, correct? 20 A. Yes. 21 Q. Did the protocols -- or was 22 this drug being given by this physician in 23 accordance with protocols? 24 MR. ARMSTRONG: Are you asking this Page 303 1 witness to testify as to the manner in which the 2 physician gave the drugs to the patient? 3 MR. SMITH: Yes. 4 MR. ARMSTRONG: Or are you asking 5 whether or not there were protocols furnished 6 which directed the use of the drug? 7 MR. SMITH: That would be a good 8 question, too, Mister Armstrong. 9 MR. ARMSTRONG: Why don't you choose 10 one. 11 Q. Go with the first one. 12 A. What was the first one? 13 Q. Did you ask the physician 14 whether or not he was administering this patient 15 Fluoxetine Hydrochloride, Prozac, according to 16 protocols? 17 A. I don't remember talking with 18 the physician about this. My inference, from the 19 nature of this note, is that they felt that this 20 patient, who had the suicidal tendencies, was 21 probably not the type of patient who fell into 22 the protocol as designed, that the patient was 23 not a depressed patient, but was a schizophrenic 24 or schizo effective. Page 304 1 Q. Well, that's the reason I was 2 asking, Doctor, is because the protocols, most of 3 them, are -- call that the medication be given to 4 individuals who are diagnosed as depressed, 5 correct? 6 A. Yes. 7 Q. Did you send protocols to this 8 physician? 9 A. Probably. 10 Q. Do you know? 11 A. I'm sure we did. 12 Q. Who would have been 13 responsible for seeing that physicians got 14 protocols back in August of 1979? 15 A. I think I would have been. 16 Q. Would they be sent by your 17 office? 18 A. Yes. 19 Q. Do you have a recollection of 20 sending this physician, who treated these two 21 patients only with Fluoxetine, drug kits? 22 A. Do I have a specific 23 recollection of having sent this man? 24 Q. Yes. Page 305 1 A. No. Do you remember what you 2 sent to somebody in 1979? 3 Q. Was this study a double-blind 4 or single-blind study that this doctor was 5 performing? 6 A. I think it was open-label. 7 Q. Were there any other 8 physicians that you know of at the time who only 9 had two patients the subject of an open-label 10 study? 11 A. It's possible that the 12 physician who was treating the patients with a 13 neuromuscular disorder had a similar small number 14 of patients. 15 Q. But this is a different 16 physician than that physician who was treating 17 patients for the neuromuscular disorder? 18 A. Yes. 19 Q. This is, as I understand it, 20 Doctor Slater, a physician who is conducting a 21 clinical trial for Lilly. 22 A. Yes. Do I know of any other -- 23 the other people with whom I was in contact for 24 the Phase 2 trial both had more than two Page 306 1 patients. 2 Q. Was this a Phase 2 trial? 3 A. Yes, I think so. 4 Q. And all of the Phase 2 trials, 5 as far as you know, excluded patients who were 6 suicidal risks, did they not, serious suicidal 7 risks? 8 A. I don't know whether that 9 exclusion was in the protocol or not. 10 Q. Well, do you know whether or 11 not there was an exclusion for patients suffering 12 from disorders such as schizophrenia or 13 schizo-effective disorders? 14 A. It may not have been a formal 15 statement saying these patients should not be 16 treated, but obviously they do not fall in the 17 category of depression, so they would not have 18 been appropriate patients for the clinical trial. 19 Q. Let's go down to the second 20 paragraph of that notation. It says I have not 21 heard from, and then a name is blacked out, in 22 several weeks. Is that the same name of the 23 physician in the first paragraph? 24 A. No. Page 307 1 Q. Is that a physician who was 2 doing a clinical trial? 3 A. Yes. 4 Q. Is it a physician who was 5 doing a pivotal clinical trial? 6 A. No. 7 Q. Your notation there says I 8 have not heard from blank in several weeks, and 9 have had no case reports. Called yesterday while 10 he was out, he did not return the call. Correct? 11 A. Yes. 12 Q. How often would it occur that 13 you would have an investigator who would not send 14 you case reports timely? 15 A. Since there were only at this 16 time two investigators, it couldn't happen very 17 often. 18 Q. The two investigators then 19 were? 20 A. Doctor Fabre and this man. 21 Q. All right. 22 A. Since the man in the first 23 paragraph stopped after the two patients. 24 Q. I thought that the name in the Page 308 1 first paragraph that's blacked out is not the 2 same as the name -- 3 A. Yes. 4 Q. So you've got Fabre -- how 5 many investigators did you have in August of 6 1979? 7 A. Three. 8 Q. We know of Fabre, correct? 9 A. Yes. 10 Q. We know of Masco. 11 A. No. 12 Q. Masco hadn't been hired yet? 13 A. Masco had not been started 14 with the drug. My recollection is that all the 15 studies done by Doctor Masco were ultimately 16 monitored by Doctor Stark and not by me. 17 Q. All right. You had Masco -- 18 I'm sorry, you had Fabre, you had the doctor 19 whose name is marked out in the first paragraph, 20 correct? 21 A. Yes. 22 Q. And you have the doctor whose 23 name is marked off in the second paragraph who is 24 not returning your calls and not providing the Page 309 1 case report forms. 2 A. Right. 3 Q. Was it unusual that your 4 investigators were not returning your phone calls 5 in August of 1979? 6 A. That's a very peculiar 7 question. Since there were only two 8 investigators we are talking about, I don't think 9 you can talk about usual or unusual. This man 10 was not -- Doctor Fabre started giving me 11 reports. 12 Q. Was there a Doctor Taber, 13 T-A-B-E-R, investigating Fluoxetine at this time? 14 A. No, Doctor Taber had nothing 15 to do with the clinical trial. Doctor Taber was 16 a physician with another drug firm who was 17 willing to tell me that he thought that Doctor 18 Masco was a reliable individual, and that his 19 company had had good experience when Doctor Masco 20 did some clinical research for them. Doctor 21 Taber is in no way involved in this business. 22 It's the same as if I asked you about that -- Mr. 23 Slacks' qualifications as an attorney. He owns -- 24 he's one of the members of this firm who owns Page 310 1 these offices, but he has nothing to do with this 2 case as far as I know. Am I making myself clear? 3 Q. Let's go back to the first 4 paragraph on page fifty-one of your August 21st, 5 1979 notation. You say one was a young man with 6 suicidal risk and increasing thought disorders 7 who probably should be classified as 8 schizophrenic or schizo-effective. Was this 9 report to you that this patient probably should 10 be classified as schizophrenic or 11 schizo-effective the report given to you by the 12 investigator or was that a judgment you made 13 yourself? 14 A. This was the investigator's 15 judgment. 16 Q. And it was the investigator's 17 judgment that the young man had suicidal risk and 18 increasing thought disorders, is that correct? 19 A. Yes. 20 Q. How long had this patient been 21 on Fluoxetine? 22 A. I don't know, I don't 23 remember. 24 Q. Do you remember the dose -- Page 311 1 A. No. 2 Q. -- that this patient was 3 receiving? 4 A. No. 5 Q. Do you remember the dose 6 called for by the protocol that was given to this 7 physician? 8 A. No. 9 Q. Do you remember generally what 10 the dosing schedule was for those protocols that 11 were used in the open-label studies, as I think 12 you said this was an open-label study? 13 A. My recollection is based not 14 on recall. But from what I have been reading 15 lately, I would gather that the doses were 16 between twenty and sixty milligrams per day. 17 Q. When you say by what I have 18 been reading lately, are you talking about -- 19 A. These notes that we're 20 reviewing now. 21 Q. Do you know whether or not -- 22 it says the patient who had suicidal risk and 23 increasing thought disorders was started on 24 Mellaril after the Prozac was discontinued, Page 312 1 correct? 2 A. That's what I was told. 3 Q. Do you know what effect the 4 Mellaril had -- 5 A. No. 6 Q. -- on this patient's suicidal 7 risk and increasing thought disorders? 8 A. No. 9 Q. Was it your impression that 10 the physician who was administering this 11 Fluoxetine to this patient took him off the 12 Fluoxetine because the patient was experiencing 13 suicidal thoughts and was having increasing 14 thought disorders while on Prozac or Fluoxetine? 15 A. My impression was that the 16 patient had had these symptoms, and that he 17 decided that the patient was not appropriate for 18 the clinical trial that had been outlined in the 19 protocol. 20 Q. Well, then, did he tell you 21 that he had just misdiagnosed the patient 22 initially? 23 A. That is my impression from 24 these notes, but I have no immediate personal Page 313 1 recall of this particular situation. 2 Q. In other words, since the 3 protocol requires exclusion of a patient who 4 presented serious suicidal risk, you went in -- 5 A. You're making the statement 6 about the protocol which I can't verify. I don't 7 remember what was in the protocol. 8 Q. When you discussed this entry 9 with Mister Armstrong and Mister Lore Monday, did 10 you mention to them whether or not any other 11 patients had experienced suicidal ideation or 12 attempted suicide while on Fluoxetine? 13 MR. ARMSTRONG: Well, I object because 14 you're clearly asking questions which relate to 15 conversations which were between counsel and 16 client. 17 MR. SMITH: Well -- 18 MR. ARMSTRONG: Isn't that the 19 specific question you asked? 20 THE WITNESS: Yes, it is. 21 MR. SMITH: But Mister Lore was 22 present -- 23 MR. LORE: Mister Lore states, on the 24 record here and now, that for purposes of Doctor Page 314 1 Slater's employment, the period of time he was 2 employed at Lilly, I believe that I represent 3 him, that I can represent him, and that I do 4 represent him. I should have objected earlier to 5 your inquiry, but I decided to let it go on, but 6 I'm going to object right now. If you disagree 7 with me, fine, but that's the position we're 8 taking, we believe it to be a valid position, 9 that while he was employed by Lilly, for that 10 period of time that I'm representing him here 11 today, I'm representing him as a former employee 12 of Lilly. Mister Armstrong is also representing 13 him because he has not worked for Lilly 14 continuously to today's date. 15 MR. SMITH: Well, this is legal talk, 16 Doctor Slater. 17 THE WITNESS: I have stopped beating 18 my wife. 19 MR. SMITH: For purposes of my 20 question to Doctor Slater, is it the position 21 that -- is it your position, Mister Armstrong, 22 that the presence of the Lilly lawyer does not 23 invalidate the attorney-client privilege? 24 MR. ARMSTRONG: I think it does not Page 315 1 invalidate the privilege for two reasons, the one 2 that Mister Lore gave, and additionally that the 3 relationship and the objectives are similar in 4 this case, I mean because this witness here is 5 being asked about what went on when he was a 6 Lilly employee, and therefore I believe that 7 there's an identity of interest to the extent 8 that what you are inquiring about went on as he 9 was employed by Lilly. 10 Q. Well, Doctor Slater, have you 11 asked Mister Lore to represent you in this case? 12 A. No. 13 Q. Have you paid Mister Lore any 14 money to represent you in this case? 15 A. No, but I -- no. 16 Q. Have you entered into any 17 contract with Mister Lore to represent you in 18 this case? 19 A. No. 20 Q. What was said between you, 21 Mister Armstrong and Mister Lore concerning 22 whether or not there were any other patients 23 during the clinical trial who had experienced 24 suicidal ideation? Page 316 1 MR. ARMSTRONG: Same objection. 2 MR. LORE: Same objection. 3 MR. SMITH: Are you making an 4 objection or are you instructing the witness not 5 to answer? 6 MR. ARMSTRONG: No, I think that's 7 privileged, you can't answer that question. 8 MS. MORTIMER: Certify that question. 9 (QUESTION CERTIFIED.). 10 MR. ARMSTRONG: I'll give you a 11 certification of questions to which the witness 12 is directed not to answer. 13 Q. All right, I want to go back 14 to your discussions with the physicians back in 15 August of 1979 concerning this patient who had -- 16 who was reported to have suicidal risk and 17 increasing thought disorders while in the 18 Fluoxetine clinical trials. Did the physician -- 19 MR. ARMSTRONG: Let me just object, 20 make a technical objection. I'm not sure, as I 21 read this, that your statement that the patient 22 had suicidal risk and increasing thought 23 disorders while in the clinical trials is 24 substantiated by the entry. The entry simply Page 317 1 says he had a patient who had those symptoms, and 2 it doesn't say it was while he was in the trials. 3 And the prospect of the patient never having gone 4 into the trials as a consequence of that 5 conclusion by the physician, remains, I think. 6 Q. Well, your notation, Doctor, 7 says that this physician had reported to you that 8 he had taken both of the patients off Fluoxetine, 9 correct? 10 A. Yes. 11 Q. Therefore the patient who was 12 having suicidal risk and increasing thought 13 disorders had had Fluoxetine for some period of 14 time, had he not? 15 A. Yes. 16 Q. And then was taken off 17 Fluoxetine, correct? 18 A. Yes. 19 Q. He was terminated from any 20 study further in connection with Fluoxetine 21 Hydrochloride, Prozac, wasn't he? 22 A. Yes, because the diagnosis was 23 not compatible with the protocol. 24 Q. Then that patient was admitted Page 318 1 to the clinical trials in violation of the 2 protocol instructions. 3 A. Presumably. 4 Q. But you can't say for a fact 5 whether or not the suicidal risk occurred after 6 only he was being exposed to Fluoxetine, can you? 7 A. My interpretation of the note 8 is that the diagnosis implies that the symptoms 9 existed before the Fluoxetine. 10 Q. Well, you don't say in your 11 note that the patient shouldn't have been 12 included as a member of the clinical trial, do 13 you? 14 A. That's precisely what the note 15 implies. 16 Q. But that's the implication, 17 that's not what you say in your note, is it? 18 A. Well, that's what it says to 19 me now, and this is written -- the diary was 20 written for my information, so it says what I 21 think it says. 22 Q. Do you have an independent 23 recollection, Doctor Slater, of this conversation 24 that you recorded here? Page 319 1 A. No. 2 Q. The only information you can 3 give us is what's being recorded here, correct? 4 A. Yes. 5 Q. And you can't tell us now what 6 your impression was then concerning this 7 particular patient, can you? 8 A. Only to the extent of what I 9 wrote. 10 Q. And that's based on as you 11 read it now. 12 A. Yes. 13 Q. Because you have no 14 independent recollection of the situation as it 15 existed at the time. 16 A. Yes. 17 Q. Did that physician report to 18 you whether or not after the patient was taken 19 off Fluoxetine, the patient continued to be a 20 suicidal risk or continued to have increasing 21 thought disorders? 22 A. I think we're getting into 23 something we already discussed about three times, 24 and the answer is I did not discuss -- I have no Page 320 1 recollection of having any further information 2 about this patient. 3 Q. So is the answer to my 4 question no? 5 A. What was the question? 6 MR. SMITH: Read it back. 7 (THE COURT REPORTER READ BACK THE 8 REQUESTED TESTIMONY.) 9 A. No. 10 Q. Did that physician report to 11 you -- it says there that the patient was started 12 on Mellaril, which is another antidepressant, is 13 it not? 14 A. No. 15 Q. What is Mellaril then? 16 A. It's a tranquilizer. 17 Q. Did that physician report to 18 you whether or not the Mellaril did anything to 19 alleviate the patient's symptoms? 20 A. I've already said that about 21 six times. 22 MR. ARMSTRONG: I object. I think 23 you've asked him follow-up questions of any 24 additional information about the patient Page 321 1 following the time frame or the notations, and I 2 thought his answers consistently were I don't 3 know anything, I don't remember anything more, or 4 I didn't get the reports. That's my recollection 5 of his testimony. And therefore, I object 6 because the question has been asked and answered. 7 Q. During the time that you were 8 monitoring the clinical trials, did you feel it 9 your responsibility or part of your job to 10 determine whether or not any side effects 11 reported while patients were on Fluoxetine was 12 causally related to ingestion of Fluoxetine? 13 A. Yes. 14 Q. And did you do that in the 15 case of this patient that you mentioned who had 16 suicidal risk and increasing thought disorders? 17 A. I didn't consider this a side 18 effect of Fluoxetine. 19 Q. I object to the answer as 20 being nonresponsive to the question. 21 A. I think it's directly 22 responsive. You asked me whether I had monitored 23 for side effects, and I said I did not consider 24 this a side effect. Page 322 1 Q. So the answer is you did not 2 do anything with respect to this patient to 3 determine whether or not the suicidal risk or 4 increasing thought disorders was causally related 5 to the ingestion of Prozac? 6 A. That's correct. 7 Q. Do you have any recollection 8 of what the problem was with the other patient? 9 A. No. 10 Q. Your notation there says the 11 other must be a simple failure, is that correct? 12 A. Yes. 13 Q. How were you classifying, 14 quote, simple failures, what did that mean to you 15 as a clinical monitor? 16 A. The patient's depression did 17 not lift. 18 Q. Well, in your judgment, as a 19 clinical monitor, was that reason to discontinue 20 a patient from the clinical trials, when their 21 depression did not lift? 22 A. Yes. 23 Q. Do you know whether or not 24 that patient that was listed as a simple failure Page 323 1 was reported to the Food and Drug Administration? 2 A. No. I assume that it probably 3 was, but I don't know. 4 Q. Well, do you know whether or 5 not while you were present the Lilly lawyers 6 called to check on any details in connection with 7 what had been reported on the other patient in 8 this physician study which was a simple failure? 9 A. I have no information on that 10 question. 11 Q. Why were you -- you make the 12 final notation we did relabel and repackage the 13 material from Fabre's study. Why were his 14 materials relabeled and repackaged? 15 A. Because they went from one 16 bottle to another bottle, because it was to be a 17 double-blind study. 18 Q. Why was there a necessity to 19 relabel and repackage the materials? 20 A. Because we took the material 21 from bottles that were labeled Fluoxetine and put 22 them in bottles that were labeled such and such 23 and such and such. That's how you do a 24 double-blind study, you have to relabel -- Page 324 1 repackage and relabel. You label one package A 2 and the next package B and the next package C, 3 and you have an entry which tells you, the 4 investigator, what's in bottle A and what is in 5 bottle B, but the investigator and the patient 6 don't know. And this is called repackaging and 7 relabeling. 8 Q. Let's turn to page fifty-two, 9 the September 6, 1979 notation. Can you read 10 that for us, please, sir? 11 A. Today in research management 12 staff approved project team status for the 13 methylanalog of nisoxetine (toloxetine). I have 14 told both Fuller and Raffey that I do not believe 15 that the company will ever recover research costs 16 from project on this one. I do think that 17 Fluoxetine will be far enough ahead so that we 18 can judge whether leukopenia is a characteristic 19 of the class or just of the methoxy derivative. 20 Q. I don't understand that 21 notation. Can you fill me in -- are you talking 22 about two different drugs? 23 A. I'm talking about three 24 different drugs. Page 325 1 Q. What are the three drugs that 2 you're discussing? 3 A. We're talking about 4 toloxetine, nisoxetine and Fluoxetine. 5 Q. And you're saying that the 6 research management staff approved project team 7 status for the toloxetine, is that right? 8 A. Yes. 9 Q. Which was the methylanalog of 10 nisoxetine? 11 A. Yes. 12 Q. Did that mean that Lilly was 13 going to begin clinical trials of that particular 14 drug? 15 A. No, it means that they were 16 going to begin toxicity studies to determine 17 whether there was any reason to do a clinical 18 trial. 19 Q. When you say I told both 20 Fuller and Roffey that I do not believe the 21 company will recover research costs from profit 22 on this one, what are you speaking of? 23 A. That I thought that setting a 24 research project up for toloxetine was a waste of Page 326 1 money. 2 Q. So the drug you're talking 3 about is toloxetine? 4 A. Yes. 5 Q. And then you say I do think 6 that the Fluoxetine will be far enough ahead so 7 that we can judge whether leukopenia is a 8 characteristic of the class or just a methoxy 9 derivative. 10 A. Just of the methoxy 11 derivative. 12 Q. What do you mean by that? 13 A. I think I told you yesterday 14 that the clinical trial of nisoxetine had been 15 terminated because of a leukopenia. 16 Q. What is leukopenia? 17 A. Decrease in white blood cell 18 count. And I thought that we would have enough 19 patients on Fluoxetine, which belongs to the same 20 general class, to know whether all the compounds 21 in this general class caused leukopenia or only 22 the methoxy derivative, nisoxetine. 23 Q. Let's go to page fifty-three. 24 Can you read the 9-25-79 notation? Page 327 1 A. I told a physician in a letter 2 that his failure to file case reports is what may 3 prevent his patients from receiving Fluoxetine. 4 Q. Which physician is that that 5 you told? 6 A. This was the physician who was 7 treating neuromuscular disorder. 8 (PLAINTIFFS' EXHIBIT NO. 4 WAS 9 MARKED FOR IDENTIFICATION AND 10 RECEIVED IN EVIDENCE.) 11 A. This is all related to the 12 neuromuscular study. 13 Q. Can you identify what's been 14 marked as Exhibit 4, Doctor? 15 A. Yes, this is the letter that I -- 16 I think this is probably the letter that I wrote 17 to him about the -- although the timing doesn't 18 seem consistent. 19 Q. What's the date of the letter? 20 A. Oh, this is -- the diagnoses 21 that have been eluding me all this time is 22 intention myoclonus. 23 Q. See, I told you I would help 24 you. Page 328 1 A. Right. 2 Q. You mention in your notation 3 in Exhibit 2, in your diary notation of September 4 25, 1979, that you told a physician in a letter 5 that his failure to file case reports is what may 6 prevent his patients from receiving Fluoxetine, 7 correct? 8 A. Yes. 9 Q. And is that letter that we 10 marked, Exhibit 4, the letter that you referred 11 to in your diary? 12 A. It could be. 13 Q. Did this physician just have 14 one patient that he was treating with Fluoxetine? 15 A. He had a few patients, I don't 16 remember how many. 17 Q. Was he treating any patients 18 that you know of for any condition -- 19 A. Yes. 20 Q. -- other than -- 21 A. Intention myoclonus? 22 Q. -- intention myoclonus? 23 A. Not to my knowledge, not with 24 Fluoxetine anyway. Page 329 1 A. May I talk to my attorney for 2 a moment? 3 Q. Sure. 4 (Witness confers with counsel.) 5 Q. Your letter is dated September 6 6th, is that correct? 7 A. Yes. 8 (PLAINTIFFS' EXHIBIT NO. 5 WAS 9 MARKED FOR IDENTIFICATION AND 10 RECEIVED IN EVIDENCE.) 11 Q. We're now going to hand you 12 another document marked Exhibit 5, Doctor Slater, 13 which is another document which is a letter to 14 you that has been submitted to us by Lilly. Can 15 you review that, please? 16 A. This is what I was discussing 17 in private with Mister Armstrong just a minute 18 ago. 19 Q. All right. Exhibit 5 is a 20 letter from this physician that we've been 21 speaking of that was treating the patients with 22 intention myoclonus? 23 A. Intention myoclonus. 24 Q. What is intention myoclonus? Page 330 1 A. It's a neuromuscular disorder 2 associated with the clonic movements, which are 3 jerky movements. 4 Q. Is there any known cause for 5 this disorder? 6 A. I think I better plead 7 ignorance. I have a vague idea, but I think it 8 may be incorrect and I don't want to enter it 9 into the record. 10 Q. Is there any known treatment 11 for this disorder? 12 A. Doctor X felt that when he 13 treated these people with 5 Hydroxy-tryptophan, 14 and a combination of 5 Hydroxy-tryptophan with 15 dopa that he was seeing improvement, and that 16 this improvement was related to an increase in 17 serotonin. And he wanted to add Fluoxetine to 18 that regimen, and he felt that I was socially 19 obligated to help him take care of these poor 20 people. Poor in the sense -- 21 Q. Unfortunate. 22 A. Unfortunate people. 23 Q. Did you agree? 24 A. I agreed to a certain point, Page 331 1 but I told him that we could not supply material 2 if he was not going to supply case reports 3 because we were going to get in trouble with the 4 FDA. 5 Q. Let's look at his letter of 6 September 19th to you, which is Exhibit 5. It 7 says Dear Doctor Slater, the protocol which you 8 sent me on August 16th looks all right with the 9 exception that you have mentioned that the 10 ophthamalogical exam could be carried out by 11 myself or somebody -- do you know who that is 12 that's blacked out there? 13 A. No, I haven't the slightest 14 idea. 15 Q. In the office, and just 16 include the external exam and fundoscopic; 17 correct? 18 A. Yes. 19 Q. You sent -- as I understand 20 it, did you send this physician a protocol in for 21 a clinical trial? 22 A. Yes. 23 Q. Was that protocol a depression 24 protocol -- Page 332 1 A. No. 2 Q. -- or was that a protocol -- 3 A. It was in response to his 4 request to do research on intention myoclonus. 5 Q. Did you consult with someone 6 to develop a protocol on how to administer 7 Fluoxetine for this particular condition? 8 A. Yes. 9 Q. Who at Lilly would you have 10 consulted? 11 A. I consulted largely with this 12 particular physician who was the expert in this 13 field. This was a concensus report between his 14 knowledge and my own experience and the 15 experience of the people such as Doctor Barnett 16 in the regulatory affairs office. 17 Q. Do you know if that protocol 18 for this study was sent to the FDA? 19 A. I don't know, but I assume it 20 was. 21 Q. At that time were you having 22 to secure approval of the protocols before you 23 could begin a study? 24 A. I don't remember. Page 333 1 Q. And I mean approval from the 2 Food and Drug Administration? 3 A. I said I don't remember. 4 Q. This physician says I believe 5 the threats in your last letter that Fluoxetine 6 may not be made able to my patients with 7 myoclonus is unfair since they should be entitled 8 to the same therapeutic advantage of modern 9 medical science as patients with more profitable 10 diseases. Is that correct, he said that? 11 A. Yes. I told him I couldn't 12 send the material if he didn't send me the 13 reports. 14 Q. He goes on to say, therefore 15 if Lilly is unable to finance the continuation of 16 this study, I will attempt to raise the money 17 myself as best I can in order that we may 18 continue to study the therapeutic use of 19 Fluoxetine in patients with myoclonus. 20 A. Right. 21 Q. Do you know whether or not 22 Lilly continued to fund that study? 23 A. I think the next note on the 24 next page says we didn't. Page 334 1 Q. You did not? 2 A. Right. Not immediately, I 3 don't know what happened after 1980. 4 Q. Do you know whether or not 5 that physician funded the study with his own 6 money? 7 A. I don't know. 8 Q. He says, therefore if Lilly is 9 unable to finance the continuation of this study, 10 I will attempt to raise the money myself as best 11 I can in order that we may continue to study the 12 therapeutic use of Fluoxetine in patients with 13 myoclonus. My question is: Why would he have 14 had to have money to continue the study? 15 A. He had to pay the people that 16 were working with him. He had technicians, he 17 had nurses, he had the problem of somebody who 18 was going to do fundoscopic examinations, and all 19 these people were going to charge. 20 Q. How many patients were 21 involved in this study according to your records? 22 A. A handful, very few. 23 Q. And this is a physician that 24 was treating these patients for this condition? Page 335 1 A. Yes. 2 Q. He was going to charge the 3 patients for the treatment that he rendered, 4 wasn't he? 5 A. I don't think so. 6 Q. Was he treating people in some 7 clinic or some hospital? 8 A. In a hospital noted for its 9 research facility. 10 Q. Some charitable group, is that 11 right? 12 A. No, a research group. 13 Q. That worked on grants? 14 A. Largely, yes. They do all -- 15 I don't understand the financing of this 16 particular institution. 17 Q. My only question is, and I'm 18 not trying to beat it to death, but I'm 19 legitimately -- 20 A. It may seem that way to you, 21 but it doesn't seem that way to me. 22 MR. ARMSTRONG: You haven't persuaded 23 him. 24 Q. I'm wondering what expenses Page 336 1 there would be in a small group like this with 2 the relatively rare condition. Obviously the 3 Fluoxetine is going to have to be supplied to him 4 by Lilly, is that right? 5 A. Without charge. 6 Q. And I would assume Lilly would 7 have continued to give that to him without 8 charge? 9 A. Yes. 10 Q. Then I just don't know what 11 other expenses that he would have had to raise. 12 Do you follow what I'm saying? 13 A. Yes. I think it merely 14 expresses your ignorance of how research is done, 15 and who pays for research. 16 Q. That may be -- is fine, 17 enlighten me. 18 A. In any study of new drugs, one 19 has to do laboratory work to establish that there 20 was no change in liver function, there's no 21 change in blood studies, you have to do, in in 22 this particular thing, perhaps frequent 23 migraines, you have to pay nurses, you have to 24 pay secretaries, you have to maintain an Page 337 1 establishment, and this cost money. 2 Q. That's if you're doing a 3 study, is that right? 4 A. It costs money whether you're 5 doing a study or not, but if you're doing a 6 specific study and you have patients who are on a 7 specific drug, then you try to charge the 8 expenses that relate directly and indirectly to 9 the performance of those studies to that 10 particular budget, if you will. 11 Q. All right. 12 A. May I ask you a question or is 13 that illegal? 14 Q. It's probably illegal, but ask 15 me anyway. 16 A. What possible relationship 17 does studies in intention myoclonus have to do 18 with any of the matters in which you're 19 interested in? 20 Q. Well, because intention 21 myoclonus is a neurological disorder, is it not? 22 A. Yes. 23 Q. Fluoxetine is working on the 24 serotonin system, is it not? Page 338 1 A. Yes. 2 Q. Which is part of the neurology 3 of human beings, is it not? 4 A. Yes. 5 Q. Fluoxetine Hydrochloride has, 6 I believe you told us earlier, a demonstrated 7 effect on the brain chemistry of those patients 8 you studied with Fluoxetine, correct? 9 A. Yes. 10 Q. As well as animals, is that 11 right? 12 A. Yes. 13 Q. And our purpose here is to 14 learn whatever we can about that. If myoclonus -- 15 intention myoclonus is irrelevant to this, it may 16 very well be, but I don't know it at this time, 17 Doctor. 18 A. Okay. 19 MR. LORE: Paul, before you move on, I 20 would just like to say that I think Exhibit 5 21 indicates that the person whose name was blanked 22 out was in fact an investigator for Lilly, an 23 investigator for which we funded a study. Albeit 24 he disagreed with the adequacy of our funding, we Page 339 1 in fact did fund his study. 2 THE WITNESS: He does mention that we 3 had given him a grant, but it was inadequate to 4 cover his costs. 5 MR. LORE: Exactly, and that's our 6 position, that he was one of our investigators 7 and not a pivotal investigator. 8 MR. SMITH: Beg your pardon? 9 MR. LORE: Not a pivotal investigator. 10 Q. Let's turn to the -- and 11 everybody hold the applause -- last notation. It 12 is October 1st, 1979, is that correct? 13 A. Yes. 14 Q. Would you read that for us? 15 A. Paul Stark will be taking over 16 Fluoxetine, revisited a physician and had a 17 friendly meeting. 18 Q. Who was that -- was that 19 physician whose name is marked out -- 20 A. This was the intention 21 myoclonus physician. 22 Q. All right. You and Doctor 23 Stark visited with this fellow and you had a 24 friendly visit, is that right? Page 340 1 A. Yes. 2 Q. Continue. 3 A. It says Mel and I -- Mel is 4 the -- all you have to find is the Mels in the 5 thing and you will be able to figure out who this 6 guy is. 7 Q. Is Mel the first name of that 8 investigator? 9 A. Yes. 10 MR. ARMSTRONG: It's not the customary 11 spelling, though, is it, Doctor? 12 A. Wanted to run a two-week 13 combination. Build Fluoxetine level, two weeks 14 on five HDP and carbi dopa, stop Fluoxetine, 15 increase dose of five HDP dopa. Stark was 16 dubious, as was Fuller and Shedden said no. And 17 then he says another six to eight months down the 18 drain. 19 MR. ARMSTRONG: Eight to twelve. 20 A. Eight to twelve months. 21 Q. All right. It was Shedden 22 that said no, another eight to twelve months down 23 the drain, is that right? 24 A. Yes. Page 341 1 Q. Is that a yes? 2 A. Yes. 3 Q. He thought that Doctor Mel's 4 study would be another eight to twelve months 5 down the drain? 6 A. I'm not sure whether this 7 refers to the time I had spent dealing with Mel 8 or whether the study would be that. The 9 implication is not clear to me at this moment. 10 Q. What was he talking about, the 11 Fluoxetine depression studies when he says 12 another eight to twelve months down the road? 13 A. No, I think all this refers to 14 the intention myoclonus studies. 15 Q. In his October 1, 1989, the 16 last notation in your diary concerning your work 17 with Fluoxetine Hydrochloride. 18 A. What? 19 Q. Is October 1, 1979 your last -- 20 the last notation in your diary concerning 21 Fluoxetine Hydrochloride? 22 A. Yes. 23 Q. You had said earlier yesterday 24 that you had a formal writing where you Page 342 1 recommended that the work -- that the clinical 2 trials on Fluoxetine continued with respect to 3 treatment of depressed individuals. 4 A. Yes. 5 Q. Where is that formal writing? 6 A. I imagine it would be in 7 project team minutes, but I don't for certain, 8 it's not in the diary. I didn't say that there 9 was a formal written thing, I think I said that I 10 had recommended that the trial should continue. 11 I don't think I ever testified that I had made 12 such a report in writing. 13 MR. ARMSTRONG: I don't remember. 14 Q. Were you asked to reduce your 15 work as a clinical monitor to file a written form 16 before you left Eli Lilly and Company? 17 A. I don't remember. 18 Q. Do you recall whether or not 19 you did? 20 A. No. 21 Q. Did you know Doctor Leigh 22 Thompson at the time reflected by this diary? 23 A. No. 24 Q. Was Doctor Leigh Thompson Page 343 1 employed by Eli Lilly and Company while you were 2 employed by Eli Lilly? 3 A. I don't think so. 4 Q. Do you know who Doctor Leigh 5 Thompson is? 6 A. Yes. 7 Q. I believe he's the chief 8 scientific officer at Eli Lilly and Company, is 9 that your understanding? 10 A. No. 11 Q. What is your understanding of 12 who Doctor Leigh Thompson is? 13 A. He's the senior medical 14 officer. 15 Q. And have you ever had any 16 conversation with Doctor Leigh Thompson? 17 A. No. 18 Q. Don't know him and haven't met 19 him? 20 A. Huh? 21 Q. You had never met Doctor 22 Thompson? 23 A. I've seen Doctor Thompson 24 once, but I have never been formally introduced Page 344 1 or had any discussion that I can recall. 2 Q. At the time you were clinical 3 monitor of Fluoxetine, the clinical trials on 4 Fluoxetine, was it ever reported to you, other 5 than possibly this one notation that we've 6 discussed, that any patients who were being 7 treated in the clinical trials with Fluoxetine 8 would develop any suicidal or violent thoughts? 9 A. No, not to my recollection. 10 Q. At any time that you were 11 employed by Lilly, did you ever review the 12 question as to whether or not Fluoxetine 13 Hydrochloride, Prozac, could induce suicidal 14 ideation in human beings? 15 A. No. 16 Q. Did you ever, while you were 17 employed by Eli Lilly and Company, ever 18 investigate the notion that Fluoxetine 19 Hydrochloride, Prozac, could cause violent or 20 aggressive behavior in human beings? 21 A. No. 22 Q. Did you ever do any animal 23 studies to determine whether or not Fluoxetine 24 Hydrochloride could induce violent or aggressive Page 345 1 tendencies in animals? 2 A. I think we reported that the 3 cat showed some increase in irritability, but 4 nothing that we would call violent or aggressive 5 behavior. 6 Q. Your terminology is, I think, 7 that those cats, who had been friends of ours for 8 years, started hissing and growling? 9 A. Yes. 10 Q. And that the -- 11 MR. ARMSTRONG: Objection. 12 Q. Is that a yes? 13 MR. ARMSTRONG: Object to growling, I 14 don't think he said growling. 15 A. I think the report said 16 hissing. 17 Q. Let's look at the report and 18 see exactly what he said because we don't want to 19 mischaracterize anything. I think it does say 20 growling, it says growl. 21 MR. ARMSTRONG: I'll withdraw the 22 objection, and apologize. 23 MS. MORTIMER: Boy, I wouldn't have 24 laid a bet on that. Page 346 1 Q. It says by the fourth day of 2 drug treatment, the cats receiving the larger 3 doses, which had been friendly for years, began 4 to growl and hiss, is that correct? 5 A. It's bad English because it 6 says the dose being friendly where actually it 7 should have referred to the cats. 8 Q. Well, you say by the fourth 9 day of treatment, the cats receiving the larger 10 doses which had been friendly for years. 11 A. And the doses hadn't been 12 friendly, it's the cats that would be friendly. 13 Q. I think your grammar is 14 correct. 15 A. No, it isn't. But I apologize 16 for having used bad grammar, and you can have 17 your meaning as you wish it, because your 18 interpretation of my bad grammar overcomes my 19 disability. 20 Q. The point is, though, Doctor 21 Slater, that the cats were growling and hissing, 22 weren't they? 23 A. Yes. 24 Q. And you certainly Page 347 1 characterized that as violent and aggressive 2 behavior on the part of the cats? 3 A. Not violent, but aggressive. 4 Q. Although -- 5 A. Although growling and hissing 6 may be defensive rather than offensive. 7 Q. Well, they had been your 8 friends for years. 9 A. They had been friendly, yes. 10 Q. They became, in your words, 11 distinctly unfriendly. 12 A. That's right, but it doesn't 13 say whether they were unfriendly in a defensive 14 or offensive manner. 15 Q. I don't even know what that 16 note says, but I guarantee you it says something 17 about somebody that's going to growl and hiss at 18 me, right, Counsel? 19 MS. HUFF: No comment. 20 Q. Did you report this aggressive 21 animal behavior to Doctor Wong, Fuller or Molloy? 22 A. I don't remember. 23 Q. Did you ever discuss with 24 Doctor Wong, Fuller or Molloy any explanation for Page 348 1 this aggressive behavior that you noted in class? 2 A. I don't remember. 3 Q. Well, you felt that was a 4 significant finding on your part, did you not? 5 A. I thought it was interesting, 6 yes. 7 Q. Do you, as a scientist, have 8 any explanation as to why these -- why Fluoxetine 9 caused the aggression that you saw in the cats? 10 A. No. 11 Q. Are you somewhat familiar with 12 the serotonin system, you are? 13 A. Somewhat. 14 Q. Do you have an opinion that 15 the serotonin system has some connection with our 16 inhibitions? 17 A. With what? 18 Q. With our inhibitions. 19 MR. ARMSTRONG: Human inhibitions? 20 MR. SMITH: Human inhibitions. 21 A. I really don't know, and I 22 don't have an opinion on the subject. 23 Q. What is your understanding in 24 your conversations with Doctor Wong, Molloy and Page 349 1 Fuller, the developers of this drug, as to why 2 Fluoxetine Hydrochloride, Prozac, has an 3 antidepressive effect on human beings? 4 A. I think it's because it 5 prevents the reuptake of 5 hydroxytryptophan. 6 Q. Why is it that reduction of 7 uptake of 5 hydroxy -- 5-HT produces an 8 antidepressant effect in some humans? 9 A. I think it's because it 10 increases the 5-HT levels in the brain. 11 Q. What is it about increased 12 5-HT levels in the brain that results in less 13 depression? 14 A. I think you're asking me more 15 than is really known about neuropharmacology at 16 this stage in the history of the world. 17 Q. You never discussed with 18 Doctor Fuller, Wong or Molloy the reasons that 19 this medication alleviated depression in some 20 individuals, was believed to relieve depression 21 in some individuals? 22 A. I think we were all of the 23 opinion that it was related to the increase in 24 the 5-HT in the brain. Page 350 1 Q. Why does increase in 5-HT in 2 the brain produce a lessening of depression -- 3 MR. ARMSTRONG: Asked and answered. 4 Q. -- according to them? 5 A. We're going around and around. 6 I said I don't think that we know enough about 7 the details to really get a categorical answer to 8 such a question. 9 Q. I understand that, but my 10 question is: Did you and Doctor Fuller, Wong and 11 Molloy ever discuss this to theorize how this 12 might work? I know that there's no conclusive 13 proof. 14 A. We probably thought about it, 15 but I think it was implicit in our understanding 16 that depression seemed to be alleviated by 17 tricyclics, which increased catecholamine levels 18 in the brain, and that depression seemed to be 19 alleviated or might be alleviated by 5 20 hydroxytryptophan -- by Fluoxetine, which would 21 increase 5-HT levels in the brain, and that some 22 brain function was being modulated by the 23 presence of these biogenic catecholamines and 24 that this effect in depressed patients seemed to Page 351 1 be beneficial, which really is all that I can 2 say. 3 Q. Up to the time that you left 4 Eli Lilly and Company, did you ever participate 5 in any studies on human beings where lumbar 6 punctures were made and spinal taps done? 7 A. I do not recall any such 8 studies. 9 Q. Do you want to take a break? 10 A. Yes. 11 (A SHORT RECESS WAS TAKEN.) 12 (PLAINTIFFS' EXHIBIT NO. 6 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.) 15 Q. Would you review the document 16 marked Exhibit 6. 17 A. It's interesting that I'm not 18 even mentioned as being present, and here I'm 19 giving a report. 20 Q. Have you had an opportunity to 21 review Exhibit 6, Doctor? 22 A. I've skimmed through it 23 quickly. 24 Q. Do you recall giving the Page 352 1 report mentioned in Exhibit 6? 2 A. No. 3 Q. You have no recollection of 4 any of the materials mentioned there? 5 A. I recognize that this was 6 consistent with what's in my diary in a general 7 sort of way, but I have no specific recollection 8 of this meeting. 9 Q. Let's get some groundwork 10 laid. What is that a meeting of? 11 A. It's a meeting of a clinical 12 research plans committee. 13 Q. Were you on the clinical 14 research plans committee? 15 A. I don't think so. 16 Q. What is the date of that 17 meeting? 18 A. January 10, 1979. 19 Q. By that time, you had been -- 20 you had agreed to oversee the Fluoxetine clinical 21 trials, had you not? 22 A. Yes. 23 Q. Do you have any idea why you 24 wouldn't be asked to be a member of the clinical Page 353 1 research plans committee since you were 2 overseeing the Fluoxetine clinical trials? 3 A. Yes. The clinical research 4 plans committee was presumably something that was 5 set up among the people in the medical department 6 who were doing clinical research, and I was a 7 member of the pharmacology department, which was 8 a preclinical department, and I would not 9 ordinarily be a member of a committee of this 10 sort. This committee was supervising or 11 overseeing all the clinical research, research on 12 antibiotics, research on whatever. 13 Q. And from time to time, you 14 would have to appear before that committee to 15 bring them up to date on the progress of your 16 studies, is that right? 17 A. Presumably. 18 Q. That's what you were doing, 19 wasn't it? 20 A. Yes, it seems so. 21 Q. As reflected by the minutes. 22 A. Yes. 23 Q. You do you have a recollection 24 of a clinical research planning committee, do you Page 354 1 not? 2 A. No. 3 Q. You don't? 4 A. No. 5 Q. None whatsoever? 6 A. No. I say this with 7 considerable honesty, I just don't remember 8 anything about it. 9 Q. Do you recall that the 10 Fluoxetine research was done in Plan A, Plan B, 11 Plan C? 12 A. No. 13 Q. Do you see there where they're 14 referring to Fluoxetine research in connection 15 with Plan A, B, C or D? 16 A. I don't see any B, but I see A 17 and C. 18 Q. Had you, as a clinical 19 monitor, ever seen a Plan A or a Plan C? 20 A. I don't remember. 21 Q. You said there that Plan A had 22 a cost of one million dollars, does it not? 23 A. I didn't say that. 24 Q. Beg your pardon? Page 355 1 A. I didn't say that. 2 Q. Didn't say that or didn't see 3 it? 4 A. I see it, but I didn't say it. 5 Q. But you don't know what Plan A 6 consisted of? 7 A. No. 8 Q. And I guess my question is 9 would Plan A have been Phase 1 or Phase 2 or do 10 you have any idea whether or not it would 11 correlate to what's commonly referred to as the 12 various phases of clinical research? 13 A. I don't know. 14 Q. There's no mention there in 15 those meetings of any proposed open-label study 16 where a physician would study only two patients, 17 is there? 18 A. No. 19 Q. Beg your pardon? 20 A. No. 21 Q. Did you report there in 22 January any agitation that had been seen in the 23 patients receiving Fluoxetine? 24 A. Since I don't remember the Page 356 1 meeting, I don't remember what I reported. 2 Q. No, is there anything recorded 3 in that exhibit that reflects your reporting 4 agitation as a side effect of Fluoxetine? 5 A. No. 6 Q. Is there anything there that 7 reflects your earlier statements that twenty 8 milligrams of Fluoxetine was worthless, and 9 twenty milligrams produced agitation -- I mean 10 sixty milligrams produced agitation? 11 A. No, not that I can see. 12 Q. Was it at that committee 13 meeting in January, 1979 that the one million 14 dollar expenditure was approved on Fluoxetine? 15 A. I don't know. 16 Q. What does it say there? 17 A. It says that somebody 18 estimated that Plan A was going to cost a million 19 dollars. 20 Q. But you don't know what Plan A 21 is? 22 A. No, I can't tell you what Plan 23 A is or was. 24 (PLAINTIFFS' EXHIBIT NO. 7 WAS Page 357 1 MARKED FOR IDENTIFICATION AND 2 RECEIVED IN EVIDENCE.) 3 Q. Doctor Slater, I'm going to 4 hand you what's been marked Exhibit 7 and ask you 5 to review that with us, please. 6 A. I've read it now. 7 Q. That reflects -- what is that, 8 Exhibit 7? That reflects a clinical research 9 planning committee meeting of November 28, 1979, 10 doesn't it, Doctor? 11 A. Yes. 12 Q. And you spoke at the meeting 13 then also, did you not? 14 A. Apparently. 15 Q. That would have probably been 16 the last time you spoke to that austere group, 17 would it not? 18 A. Yes. 19 Q. Because you retired within 20 about a month. 21 A. Actually, I had stopped 22 working and moved to Naples and occupied my 23 present dwelling on October 22nd, and was -- had 24 went to Indianapolis for a week for this meeting, Page 358 1 among other things. 2 Q. So do you recall that meeting, 3 Doctor Slater? 4 A. No. I don't recall the 5 meeting, but I know that's what I was doing in 6 Indianapolis, was bringing to a close my work. I 7 had a lot of vacation time accumulated, and I was 8 able to leave in the middle of October and work 9 another week, and my vacation time ran out on the 10 31st of December -- well, no, at the beginning of 11 the Christmas vacation, whenever that was. And 12 then I was asked to visit Doctor Bremner on the 13 west coast, so I got two extra days pay. 14 Q. All right. Even though you 15 may not recall a meeting, do you recall the 16 accuracy of the report, does the report appear to 17 be accurate to you -- 18 A. Yes. 19 Q. -- in connection with the 20 status of the work on Fluoxetine? 21 A. Yes, uh-huh, yes. 22 Q. Do you recall whether or not 23 you had ever made the clinical research planning 24 committee aware of this study involving two Page 359 1 individuals that was discontinued? 2 A. Which one? 3 Q. The one where -- the one in 4 August of 1979 where one patient reported -- was 5 reported as a suicidal risk and increasing 6 thought disorder, and the other was classified as 7 a simple failure. 8 A. I do not recall specifically 9 ever reporting this directly to anybody, but 10 probably did. 11 Q. Who would have been the 12 individual that you would have probably reported 13 this to? 14 A. I may have mentioned it to 15 Doctor Bendush or Doctor Shedden, and perhaps to 16 Doctor Stark, but I have no recollection on the 17 subject. You have to remember that my 18 interpretation of the finding was that here was a 19 patient who should not have been put on the drug 20 in the first place, who was taken off the drug 21 after a few days, and I didn't feel it was a 22 terribly revealing business except that the 23 doctor had made a mistake and put the wrong kind 24 of patient on the drug. Page 360 1 Q. Did you ever do anything to 2 minimize the risk that your clinical 3 investigators would not put the wrong kind of 4 patients on a drug? 5 A. I wrote protocols. 6 Q. That was designed to minimize 7 the risk that improper patients would be studied, 8 isn't that correct? 9 A. Yes. 10 Q. Because what the intention 11 was, as I understand it, was to write a protocol 12 that would be revealing scientifically with 13 respect to the effect of the drug on the patient, 14 correct? 15 A. Right. 16 Q. For treatment of the 17 particular condition the drug was being 18 investigated for. 19 A. Yes. 20 Q. Is that right? 21 A. Yes. 22 MR. SMITH: Why don't we stop and eat 23 and talk about some -- 24 THE WITNESS: Are we going to be able Page 361 1 to get back in the building? 2 MR. SMITH: I think so. 3 (A LUNCH RECESS WAS TAKEN.) 4 (PLAINTIFFS' EXHIBIT NO. 8 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 Q. Have you had an opportunity to 8 review Exhibit 8, Doctor Slater? 9 A. Yes. 10 Q. Exhibit 8 appears to be a 11 letter dated July 23, 1979 from Doctor H.A. 12 Bartlett M.D., the medical advisor for regulatory 13 affairs with Eli Lilly and Company, is that 14 correct? 15 A. Yes. 16 Q. And that is a letter to the 17 Food and Drug Administration, is that correct? 18 A. Yes. 19 Q. And that concerns Fluoxetine 20 Hydrochloride? 21 A. Yes. 22 Q. You are listed as a recipient 23 of a carbon copy up on the top of the first page. 24 A. Yes. Page 362 1 Q. Do you recall seeing that 2 letter? 3 A. No. 4 Q. If you will look with me at 5 the one, two -- third paragraph on page one of 6 Exhibit 8. It looks like the letter is in 7 reference to IND protocol number thirteen, 8 doesn't it? 9 A. Yes. 10 Q. Which was a study involving 11 Prozac, Fluoxetine Hydrochloride, at the time, 12 correct? 13 A. Yes. 14 Q. The third paragraph says the 15 initial dose of Fluoxetine will be one 16 twenty-milligram capsule given in the morning of 17 the first day. On days two and three, a twenty 18 milligram capsule will be given both in the 19 morning and at noon. On day four, two 20 twenty-milligram capsules will be begin in the 21 morning, and one twenty-milligram capsule at 22 noon, correct? 23 A. Yes. 24 Q. At the investigator's Page 363 1 discretion, this dose may be continued for five 2 weeks, is that correct? 3 A. Yes. 4 Q. It says it may be reduced if 5 clinically indicated, and in instances where the 6 dose is reduced because of agitation, Diazepam 7 may be administered as needed, correct? 8 A. Yes. 9 Q. Now, Diazepam is an 10 antianxiety agent, is it not? 11 A. Yes. 12 Q. And did Doctor Bartlett -- 13 A. Barnett. 14 Q. Barnett consult with you in 15 connection with protocol number thirteen? 16 A. I don't remember. 17 Q. You were knowledgable 18 concerning protocol number thirteen at the time, 19 were you not? 20 A. Probably, but I have no direct 21 recollection of it. 22 Q. Were there patients who were 23 becoming agitated on Fluoxetine in the clinical 24 trials? Page 364 1 A. I don't remember that, but I 2 would infer that patients given very large doses 3 may have been. 4 Q. It says at the investigator's 5 discretion, this dose may be continued for five 6 weeks. It may be reduced if clinically 7 indicated, and in instances where the dose is 8 reduced because of agitation, Diazepam will be 9 administered as needed, correct? 10 A. Yes. 11 Q. Of course the maximum that is 12 going to be given to a patient under that 13 paragraph would be eighty milligrams a day, would 14 it not? 15 A. I calculate sixty, but -- 16 Q. All right, sixty. Do you 17 consider sixty very large doses of Fluoxetine? 18 A. I'm really not that familiar 19 with this phase. My understanding is that the 20 present dose is twenty milligrams per day, 21 usually. 22 Q. Well -- 23 A. So that I would think that 24 this, in the light of later knowledge, would fall Page 365 1 under the category of large doses. 2 Q. Sixty milligrams would be a 3 large dose in your judgment, is that correct? 4 A. Yes, but this is not an expert 5 opinion, it's just an inference from what little 6 I know. 7 Q. From what you knew as clinical 8 investigator in 1979, did you consider sixty 9 milligrams a large dose of Fluoxetine? 10 A. This was about the dose -- we 11 were dealing between forty and sixty and trying 12 to find what would be an appropriate dose. 13 Q. My question was: Did you 14 consider sixty milligrams a large dose in 1979 15 when you were a clinical monitor? 16 A. I really don't remember. 17 Q. Do you recall it being given 18 in dosages in excess of sixty milligrams while 19 you were the dosage monitor? 20 A. I don't recall. 21 Q. Do you recall the agitation 22 occurring only in sixty milligrams? 23 A. I have no recollection. 24 Q. Well, you recall the agitation Page 366 1 occurring, don't you? 2 A. No. This is fifteen years 3 ago, I don't remember. 4 Q. I understand. But we looked 5 at -- 6 A. You're asking me if I recall, 7 and not if I can read, and I do not recall this 8 problem. 9 Q. Can you read now that sixty 10 milligrams or some dosage was causing agitation? 11 A. I think that's a presumption 12 from this. 13 Q. Do you think that's a 14 reasonable presumption? 15 A. Yes. 16 Q. And Diazepam was being 17 administered -- could be administered in the 18 investigator's discretion to reduce the anxiety? 19 A. Yes. 20 Q. Was there ever any study done 21 to examine the effects of Fluoxetine and 22 Diazepam, the antianxiety agent, being given 23 together? 24 A. I don't remember. Page 367 1 Q. Would any protocol amendments 2 have had to have been reviewed by you back in 3 July of 1979? 4 A. Probably. 5 Q. Would you look at the last 6 paragraph. There's a mention of the 7 administration of chloral hydrate for sleep will 8 not be restricted, but only once a week as 9 indicated in the protocol. Do you recall chloral 10 hydrate being administered for sleep to patients 11 who participated in the Fluoxetine clinical 12 trials? 13 A. My recollection is that we had 14 selected this as a compound less likely to cause 15 trouble than barbituates, but that's all I can 16 remember of that. 17 Q. Less likely to cause what kind 18 of trouble, Doctor Slater? 19 A. Excessive sleep and so on, or -- 20 that's all I can say. 21 Q. What is chloral hydrate? 22 A. Chloral hydrate is a 23 sleep-producing drug. 24 Q. What is the brand name? Page 368 1 A. I think it's a generic 2 substance, I don't know of anybody who marketed 3 it under a brand name. There may be, but I don't 4 know. 5 Q. But it's a substance that 6 requires a prescription, you can't go into a 7 pharmacy and -- a lay person and pull some 8 chloral hydrate off a shelf? 9 A. I don't think so. 10 Q. Is chloral hydrate Librium? 11 A. No, no. 12 Q. Do you know why there was the 13 lifting of the restriction to chloral hydrate to 14 allow the administration of chloral hydrate more 15 than once a week if indicated by the 16 investigator? 17 A. I would guess that they wanted 18 to be able to give sleeping medication more than 19 once a week. 20 Q. Because do you recall that 21 patients -- 22 A. I don't recall any problem. 23 Q. Do you recall that patients 24 who participated in the clinical trial while you Page 369 1 were there were reporting some insomnia? 2 A. No. 3 Q. Insomnia was something you had 4 never heard of being reported as a reaction to 5 patients taking Fluoxetine? 6 A. It's fair to say I don't 7 recall, which is different from saying I never 8 heard. 9 Q. Were there ever studies, any 10 studies, done to measure the effects of 11 Fluoxetine taken concomitantly with chloral 12 hydrate that you're aware of? 13 A. No. 14 (PLAINTIFFS' EXHIBIT NO. 9 WAS 15 MARKED FOR IDENTIFICATION AND 16 RECEIVED IN EVIDENCE.) 17 Q. I hand you a document, Doctor 18 Slater, that's marked Exhibit No. 9 and ask you 19 if you can review that document so we can talk 20 about it. 21 A. Yes. 22 Q. Exhibit No. 9 is a letter you 23 authored dated August 15, 1979, is it not? 24 A. Yes. Page 370 1 Q. And is that to a medical 2 doctor or someone else? 3 A. I don't know, the name is 4 blacked out. 5 Q. Do you have a recollection -- 6 A. No. 7 Q. -- as to whether or not that 8 would have been a medical doctor? 9 A. No, but I suspect it probably 10 was. 11 Q. It looks to me -- I'm waiting 12 for your lawyer to let you have it. It looks to 13 me that by virtue of the last paragraph in the 14 document where it says I'm anxious to continue to 15 collect data on the use of Fluoxetine as a 16 treatment for major depressive disorders, it has 17 been some time since we received a case report 18 from your unit, is there any hope that you can 19 continue the studies you started some time ago, 20 end quote. I assume that that's a letter to an 21 investigator that had at least begun a study for 22 you? 23 A. Yes. 24 Q. Is that right? Page 371 1 A. (Witness moves head up and 2 down.). 3 Q. Do you have a recollection now 4 as to -- 5 A. Who this is? 6 Q. -- who this is? 7 A. My only comment is that this 8 may well be related to the note in the diary 9 about my letter to an investigator saying it's 10 been some time since we had a case report from 11 you, but I don't remember writing this particular 12 letter, although there's some mention of it in 13 the diary. 14 Q. In the first paragraph, you 15 review that you have had two investigators 16 working on studies involving the drug, and that 17 recently a third investigator has started using 18 the drug. And you report that all three of these 19 investigators have reported lifting of depression 20 during the first week in some of their patients. 21 Some patients have become agitated, while a few 22 complain of excessive sleepiness. Do you see 23 that there? 24 A. Yes. Page 372 1 Q. Do you recall, Doctor Slater, 2 whether or not there were more patients who had a 3 lifting of depression than there were more 4 patients who had become agitated while on the 5 drug? 6 A. No. 7 Q. Do you recall, Doctor Slater, 8 as we sit here today whether or not there were 9 more patients who had reported excessive 10 sleepiness than had reported a lifting of 11 depression? 12 A. No. 13 Q. Do you recall as we sit here 14 today, Doctor Slater, how many patients, because 15 you say some, had a lifting of depression during 16 the first week? 17 A. I don't remember. 18 Q. Does Diazepam affect the brain 19 chemistry? 20 A. I think the answer is yes. 21 Q. Does it affect the serotonin 22 system? 23 A. I don't think so. 24 Q. Does Diazepam cause Page 373 1 physiological changes in the brain chemistry of 2 humans? 3 A. I think the answer has to be 4 yes, but whether the detail and the accuracy, 5 what the changes might be, I haven't kept up with 6 the literature and I think most of the data have 7 been published after I stopped working actively 8 in the field of central nervous system drugs. 9 Q. Do you see a problem or did 10 you see a problem at the time, Doctor Slater, 11 with getting an accurate picture of a patient's 12 mental status who is being administered both 13 Fluoxetine and Diazepam concomitantly? 14 A. My thinking at the time was 15 that my role was determined whether Fluoxetine 16 would cause lifting in depression in what was a 17 group of patients on refractory to, in large 18 measure, refractory to standard medication. And 19 my attitude had been that if a few patients 20 showed relatively unequivocal improvement in this 21 group of resistent patients, then it would 22 justify expanding the clinical trial, and I would 23 have answered the original question that was 24 posed to me, should we or should we not go ahead, Page 374 1 in the positive. In other words we should go 2 ahead. I didn't, in any sense, feel that my 3 study was going to establish dosage or the 4 detailed clinical indications or how widely 5 successful the drug would be, all I hoped to 6 establish was whether the data that I collected 7 would be sufficient to say this appears to have 8 some antidepressant activity. So my question in 9 great detail about interactions, about percentage 10 of patients who I expected to see improved, are 11 really out of line. 12 Q. Well, I'm going to ask it 13 again Doctor, my question didn't raise any 14 objection from either your counsel or Lilly's 15 counsel, and I'm entitled to an answer on that. 16 A. I gave you an answer. 17 Q. No, you didn't give me an 18 answer. My question to you was: Did you see any 19 problem, from a medical or scientific standpoint, 20 in getting an effective determination of the 21 mental status of patients when you were 22 administering Fluoxetine Hydrochloride and 23 Diazepam concomitantly in some patients? 24 A. No. Page 375 1 (PLAINTIFFS' EXHIBIT NO. 10 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. I hand you a document that's 5 been marked Exhibit 9 -- 10, and ask you to 6 review it, Doctor Slater. 7 A. (Witness complies.) 8 Q. Doctor Slater, I've handed you 9 an exhibit marked Exhibit 10. Can you identify 10 that exhibit? 11 A. It's a memorandum to Dan 12 Russell who was a man in the medical affairs 13 committee who was assigned to help me with 14 clinical trials. 15 Q. He was assigned to help you 16 with the clinical trials? 17 A. Uh-huh. 18 Q. Is that a yes? 19 A. Yes. 20 Q. Was Mister Russell your 21 assistant? 22 A. He was, in a sense, yes, but 23 not necessarily -- I don't remember whether this 24 was his only assignment, but he was assigned to Page 376 1 assist me, but he was not necessarily my 2 assistant. In other words, he didn't belong to 3 me, he belonged to the medical affairs committee. 4 Q. Was Dan Russell a medical 5 doctor? 6 A. No. 7 Q. Was he a chemist? 8 A. No. I don't remember what his 9 qualifications were, I don't remember what his 10 qualifications were. He had been in this 11 component for some time, and was familiar with 12 the mechanism of clinical trials. 13 Q. But you don't know what his 14 educational background is? 15 A. No, it would be a mistake to 16 tell you. 17 Q. Is Mister Russell still with 18 Eli Lilly and Company, as far as you know? 19 A. I have no idea. 20 Q. How about Mister T.H. Bratten, 21 Junior, who is he? 22 A. I don't know. I think he was 23 a man who went around the country checking 24 clinical investigators on a regional basis. Page 377 1 Q. Well, he has under there a 2 title clinical research coordinator, does he not? 3 A. Yes. 4 Q. But he's not like the head of 5 the clinical research planning committee or 6 something of that nature, is that what you're 7 saying? 8 A. No, he's apparently a man with 9 a post-doctoral degree, he's referred to as 10 mister. 11 Q. In your recollection, he was 12 an individual that worked outside of Indianapolis 13 and visited various clinical study sites? 14 A. I think so. 15 Q. It says I recently visited 16 with, and then there's two lines or two names 17 marked out there. Do you have a recollection of 18 who that would have been? 19 A. No. I might make an 20 inference, but I don't know for sure. 21 Q. It says -- the letter says it 22 was learned that they had enrolled four patients, 23 however two of these patients never returned 24 after the first visit. One other patient Page 378 1 completed seven visits out -- or but had only 2 minimal improvement and experienced excessive 3 stimulation as a side effect. Another patient 4 discontinued the study at visit three because of 5 lack of efficacy. The doctor had also indicated 6 that extreme agitation was a side effect in this 7 patient, correct? 8 A. Yes. 9 Q. Now, Doctor Slater, did you 10 ever see any case report forms from this 11 physician, this investigator, that indicated that 12 of the four patients who were enrolled, two 13 patients never returned after the first visit? 14 A. I don't remember seeing such 15 forms. 16 Q. Do you remember -- 17 A. I don't know whether they came 18 or not. 19 Q. Do you remember receiving any 20 case report forms indicating excessive 21 stimulation -- 22 A. No. 23 Q. -- as a side effect reported 24 by one of the patients? Page 379 1 A. No. 2 Q. Do you remember whether or not 3 a 1639 was filled out -- 4 A. No. 5 Q. -- in connection with this 6 excessive stimulation as a side effect from the 7 drug? 8 A. No. 9 Q. Based on your recollection, 10 and I know it's been some period of time, would 11 excessive stimulation be a side effect that would 12 have required you as clinical coordinator of 13 Fluoxetine to ensure that a form 1639 was filed 14 with the Food and Drug Administration? 15 A. No, that would be the 16 responsibility of the medical affairs business, 17 my responsibility was to notify them. 18 Q. How were you notifying 19 regulatory affairs about side effects reported on 20 this drug? 21 A. I would send them copies of 22 reports that I had or send them the original 23 report. 24 Q. Of the case report forms as Page 380 1 they came in? 2 A. Yes. I must admit that I 3 don't remember whether reports came to me 4 directly or went to the medical affairs directly. 5 Am I making myself clear? 6 Q. Yes. 7 A. Okay. 8 Q. But I would assume that most 9 of the case report forms that had the clinical 10 information would have to come to you or to 11 someone at your direction because you were 12 overseeing the medical aspects of the treatment, 13 is that correct? 14 A. Yes, probably. 15 Q. Do you recall seeing a case 16 report form on the other patient who reported 17 extreme agitation as a side effect? 18 A. No. 19 Q. Do you recall reviewing case 20 reports from this particular investigator that 21 you had the impression were sloppily filled out 22 and incomplete? 23 A. No. 24 Q. Do you recall any case report Page 381 1 forms from any investigators that you received 2 that were sloppily filled out and incomplete? 3 A. Not specifically, no. 4 Q. Well, do you remember that as 5 being a problem generally? 6 A. No, I don't think so. 7 Q. Do you have any idea why 8 Mister Bratten, the clinical research 9 coordinator, would be reporting this as an 10 observation on his part? 11 A. I think it's evident from 12 what's in the report. 13 Q. I beg your pardon? 14 A. I think it's self-evident in 15 the report. 16 Q. What is self-evident? 17 A. The fact that things were not 18 going perhaps as well as he thought they should. 19 Q. Were all the investigators 20 being paid for their clinical trials based on a 21 number of patients enrolled basis? 22 A. I think all the investigators 23 were receiving grants from Lilly, not necessarily 24 on based on a per patient cost however. Page 382 1 Q. Well, were some of them based 2 on a per patient cost? 3 A. I think some of them were 4 based on if they had completed a study with a 5 certain number of patients they would receive a 6 certain amount of funds, but it was not 7 necessarily on a per patient basis. 8 Q. On those that weren't on a per 9 patient basis, the payments or grants were 10 dependent upon the investigator enrolling a 11 certain number of patients, is that right? 12 A. Usually, uh-huh. 13 Q. Mister Bratten concludes that 14 it is my impression that this study will never be 15 completed satisfactorily, correct? 16 A. Yes. 17 Q. Do you know whether or not the 18 study was completed? 19 A. No. 20 Q. Did you have the same 21 impression based on reading this letter? 22 A. I probably was discouraged, 23 but I don't remember. 24 Q. Do you remember any studies Page 383 1 that weren't completed? 2 A. No. 3 Q. Do you remember any studies 4 that had to be discontinued? 5 A. I remember one study that was 6 discontinued because the investigator apparently 7 lost interest in the project. 8 Q. Which study was that? 9 A. This was a study in which one 10 patient that we discussed at great length earlier 11 this morning, one patient was inappropriately put 12 on the drug because the patient presumably did 13 not have the depression but had schizo or 14 schizo-effective disease, and the other patient 15 had not responded quickly, and that investigator 16 never did anymore than returned the grant. 17 Q. He did return his grant money? 18 A. Yes. 19 Q. What was the name of that 20 investigator? 21 A. I think that's privileged 22 information. 23 MR. ARMSTRONG: That's been the 24 instruction before, Counsel, and hasn't that been Page 384 1 the response? 2 MR. SMITH: It wasn't instructed in 3 connection with that line of questioning. 4 MR. LORE: I object. 5 MR. ARMSTRONG: Do we have to keep 6 going through this? 7 MR. SMITH: I've got to make a record. 8 I think I'm going to have to demonstrate to the 9 judge several reasons why I'm entitled to this 10 name. 11 MR. ARMSTRONG: I think you haven't 12 come up with one yet, but go ahead. 13 MR. SMITH: Well, see, you're not a 14 judge, Jim, and you probably wouldn't get my vote 15 even if you were running. Do they have judges by 16 election down here in Florida? 17 MR. ARMSTRONG: They keep them by 18 election. 19 MR. SMITH: Keep them by election. 20 Were you ever appointed a judge, Jim? 21 MR. ARMSTRONG: I never aspired to be 22 a judge. 23 MR. SMITH: I thought maybe you had 24 been defeated already. Page 385 1 MR. ARMSTRONG: No, no, but I can 2 assure you that if I wanted to get reelected, I 3 would not count on you for support. 4 MR. SMITH: Thank you, very much. 5 Q. For purposes of the record, 6 what was the name of the investigator whose study 7 was not completed? 8 MR. ARMSTRONG: For purposes of the 9 record, that is information we're not prepared to 10 disclose. 11 MR. LORE: Lilly joins in that 12 objection. 13 MR. SMITH: And are you instructing 14 him not to answer? 15 MR. ARMSTRONG: Yes. 16 MS. MORTIMER: Certify that question. 17 (QUESTION CERTIFIED.). 18 MS. MORTIMER: I'm not even sure that 19 it is a rule in Kentucky, but I know it's one in 20 Illinois. 21 THE WITNESS: Now that I see how much 22 I don't remember, I wonder if my memory of this 23 is accurate. 24 Q. You resigned December the Page 386 1 31st, 1979, is that correct? 2 A. No, I retired, I didn't 3 resign. 4 Q. Retired December 31st, 1979. 5 A. Yes. 6 (PLAINTIFFS' EXHIBIT NO. 11 WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 Q. Do you recall receiving the 10 letter dated December 24, 1979? 11 A. No. 12 Q. Do you recall the study that 13 this professor of psychiatry was conducting? 14 A. No. Since I don't know who -- 15 since they've blacked out the name. 16 Q. Well, if they didn't black out 17 the name, would you think it would help you in 18 your recollection of the subject matter of this 19 correspondence? 20 A. I suspect it might. 21 Q. Do you know why there's a 22 stamp on the top of the page with a corrected 23 copy written in? 24 A. No. Page 387 1 Q. Is that something -- off the 2 record. 3 (DISCUSSION OFF THE RECORD.) 4 Q. The letter says enclosed find 5 the data on the last patient treated on the 6 Fluoxetine study. As the records indicate, this 7 patient experienced psychotic worsening on active 8 drug which improved somewhat after it was 9 discontinued, correct? 10 A. Yes. 11 Q. Do you have a recollection of 12 a patient that was participating in a clinical 13 trial that had psychotic worsening? 14 A. No. 15 Q. Do you recall any patients who 16 became psychotic? 17 A. No. 18 Q. Do you recall any patients who 19 were psychotic to begin with the study? 20 A. Yes. 21 Q. The schizo that you were 22 talking about? 23 A. Yes. 24 Q. Other than that? Page 388 1 A. No. 2 Q. Of course we know this is a 3 different patient, don't we, by virtue of the 4 contents of this letter? 5 A. Yes. 6 Q. Because this has to do with 7 eleven patients. And we know that your diary 8 notation had to do with a study where there were 9 only two patients treated, right? 10 A. Correct. 11 Q. And those two patients both 12 dropped out and the study was never completed, 13 correct? 14 A. That's correct. 15 Q. But this is a different study? 16 A. Yes. 17 Q. And this is a psychotic 18 worsening of a different -- in a different 19 patient? 20 A. Uh-huh. 21 Q. Correct? 22 A. Correct. 23 Q. So we know of those studies -- 24 we had two patients that experienced psychotic Page 389 1 worsening or had psychotic reactions while on 2 Fluoxetine? 3 A. No. 4 Q. Whether caused by the drug or 5 not caused by the drug. 6 A. No, we had two patients -- we 7 have one patient which uses the term psychotic 8 worsening -- I don't know what this means, and I 9 may suspect you don't either. And the other 10 patient, we don't have any indication that the 11 patient's psychosis changed, all we know is that 12 he had suicidal ideation and they decide he was 13 not appropriate for Fluoxetine. 14 Q. We don't know whether the 15 suicidal ideation came on before or after the 16 study, do we, Doctor, all we know is what's 17 written in your note, correct? 18 A. Correct. So I don't think 19 it's correct to call it worsening. 20 Q. Well, this professor of 21 psychiatry talks about psychotic worsening in 22 this letter, doesn't he? 23 A. Yes. 24 Q. With respect to this other Page 390 1 patient, doesn't he? 2 A. Uh-huh. Can I make a comment? 3 Q. Well, answer my question. 4 A. Yes. 5 Q. All right. Did you have any 6 doubt in this professor of psychiatry's abilities 7 to diagnose psychotic worsening? 8 A. No. 9 Q. He goes on -- the professor of 10 psychiatry goes on to say, in review of the 11 eleven patients treated with Fluoxetine, we were 12 not impressed with the antidepressant activity of 13 the drug. There were two patients that entered 14 remission on the study, and in both cases we 15 questioned whether this was drug related. In the 16 others, there was either no change or clinical 17 worsening. Side effects were minimal on any of 18 the dosage regimens. Correct? 19 A. That's correct, and I think 20 that there's only one conclusion that we can 21 reach. That this is a man who found -- was 22 unable to find activity, antidepressant activity 23 with a drug which has since proved to be 24 unquestionably an effective antidepressant drug Page 391 1 in ten million patients. So the value of this 2 particular piece of paper is -- 3 Q. You just don't like what it 4 says, do you, you disagree with -- 5 A. No, I don't have to disagree 6 with him, I think history disagrees with him. 7 Q. I'm asking you about facts 8 recited in this letter from a professor of 9 psychiatry that Lilly had apparently hired to do 10 a clinical study, hadn't they? 11 A. Yes. 12 Q. And at least at one time Lilly 13 had -- Lilly or you had some opinion concerning 14 his judgment with respect to matters of 15 psychiatry, didn't they? 16 A. Yes. 17 Q. Whether time proves him right 18 or wrong, I never asked you about that, did I? 19 MR. ARMSTRONG: Because you didn't 20 want to hear it. 21 A. Because you didn't want to 22 hear the answer. 23 Q. I never asked you about it, 24 did I? Page 392 1 A. I'm giving you the answer 2 regardless, because it's self-evident from the 3 data in front of you. I think you should be 4 honest and ask questions that are relevant to the 5 issue at hand. 6 Q. Do you think then, Doctor, 7 that of the over three thousand people that have 8 reported suicidal ideation, suicide attempts, or 9 completely suicidal on this drug, of those three 10 thousand people, none of them are drug related? 11 MR. LORE: I object to the form of the 12 question, facts not evidence. You may still 13 answer if you can, if you understand the 14 question. 15 A. My personal impression is that 16 depressed patients who have suicidal ideation are 17 very common, and it's very difficult to evaluate 18 whether the suicidal ideation that they report is 19 drug related or disease related. That's my firm 20 opinion. 21 Q. That's your opinion, but 22 that's not the answer to my question. 23 A. Your question was, was it my 24 opinion that these were unrelated, and I told you Page 393 1 that I don't know. 2 Q. All right. Your answer is you 3 don't know whether or not of the three thousand 4 people that have reported suicide, suicidal 5 ideation or suicide attempts, whether any of 6 those or all of those or some of those could be 7 related to taking Prozac, do you? 8 A. No. 9 Q. You understand, Doctor, that 10 we don't have any question or any dispute with 11 whether or not this drug has an antidepressant 12 effect in some people. 13 A. Yes. 14 Q. Our problem with this drug is 15 that there are over three thousand reports of 16 suicidal ideation, suicide attempts or completed 17 suicide with this drug. Does that help you in 18 knowing where I'm coming from in connection with 19 my questions? 20 A. It helps me understand your 21 bias, yes. 22 Q. I understand your bias, too, 23 Doctor, and I respect your bias. This drug was 24 developed by three individuals who you recruited Page 394 1 to Eli Lilly and Company, correct? 2 A. Yes, and this drug has helped 3 an awful lot of people. 4 Q. Do you think that the fact 5 that this drug has helped a lot of people would 6 justify putting the drug on the market if some 7 people were committing suicide as a result of 8 ingestion of this drug? 9 MR. LORE: I object to the question, 10 it's argumentative. 11 A. I have not stopped beating my 12 wife, I think, is the answer to the question. 13 The way the question is phrased, makes it 14 impossible to give an honest answer. 15 Q. You just can't answer that 16 question? 17 A. The question is not 18 answerable. 19 Q. Why? 20 A. Because it presupposes a 21 damaging effect. 22 Q. You said you don't have any 23 opinion whether or not it has a damaging effect 24 on some individuals, didn't you? Page 395 1 A. I think that's right. 2 Q. If you don't have any opinion, 3 can you assume with me or can you make the 4 assumption for purposes of my question that there 5 may be -- whether or not -- can you make the 6 assumption that if the drug presented a risk to 7 some people, that the people who are helped by 8 this drug far outweighs the risk to those people 9 who are harmed by that drug? 10 MR. LORE: I object to the question 11 because I don't understand it. Doctor, if you 12 can understand what he's asking, you can answer, 13 but I'm making that objection as to the form of 14 the question. 15 A. The philosophical question of 16 risk to benefit is always a very difficult one to 17 answer, and I would prefer not to answer it 18 because I feel that the answer is likely to 19 prejudice the view because it can be so easily 20 distorted. 21 Q. Well, I never intended to ask 22 you that question, Doctor, until you began 23 telling me what a great drug this was because it 24 helped ten million people who were depressed. Page 396 1 And my question to you is: Is it worth any life 2 if it helps ten million people become less 3 depressed? 4 MR. ARMSTRONG: Is it worth? 5 Q. Is the risk of the drug worth 6 helping ten million people? 7 A. If among the ten million 8 people there were really depressed patients who 9 had suicidal ideation, whose depression was 10 lifted by the drug and who didn't commit suicide, 11 would one say that the fact that from the 12 patients who were not helped by the drug did go 13 on to commit suicide, does not imply necessarily 14 that the drug caused them to commit suicide, all 15 it says is this is a part of the disease. 16 Q. You just can't get past that, 17 can't you? 18 A. I can't get past an idea -- 19 Q. That suicide is part of 20 depression. 21 A. That depression a part of a 22 disease associated with suicidal ideation. In 23 general the symptoms of the disease in many 24 patients are helped by this medication. Now Page 397 1 whether this specific syndrome is helped in large 2 numbers of patients justifies the fact that some 3 patients may not improve, is sort of irrelevant. 4 Q. What if the drug caused denovo 5 suicidal ideation in numbers of patients? 6 A. I don't believe this occurs. 7 Q. Based on what scientific data? 8 A. Perhaps on my own prejudice. 9 Q. All right. Let's go back to 10 Exhibit 11. 11 A. Side effects were minimal on 12 any of the dosage regimens. 13 Q. Well, are you proud of that 14 part of that letter? 15 A. I think that's an interesting 16 part of the letter. 17 Q. Probably the only part of the 18 letter you like, isn't it, Doctor Slater? 19 A. Well, I also am not too 20 unfavorably impressed with the fact that two 21 patients did improve, even temporarily, because 22 these were all drug resistant patients. In other 23 words, these were patients, all eleven of them, 24 who had not responded to many other drugs, and Page 398 1 two of them had responded favorably to this drug. 2 Q. Tell me what protocol ever 3 drafted by you or in which you participated in 4 called for patients to be selected from groups of 5 patients who had not responded to other 6 conventional antidepressant medication. 7 A. The protocols were drawn for 8 people -- for research physicians who were seeing 9 patients who had depressed syndromes, and most of 10 these were, as we all knew, patients who had 11 failed with other therapies, otherwise they would 12 not have been on an experimental drug, they would 13 have been on a standard medication. 14 Q. How do you know that? You 15 know Doctor Fabre was advertising for patients, 16 don't you? 17 A. Yes. 18 Q. So do you think -- did you see 19 his ads? 20 A. No. 21 Q. Do you have any indication 22 that he was advertising for patients who had 23 failed to become less depressed on conventional 24 antidepressant medications? Page 399 1 A. He was not advertising for 2 that, but the fact that the patients were coming 3 to him with depression implies that they had been 4 around for a while. 5 Q. Why, why is there that 6 implication that they had been around for a 7 while? 8 A. Because depressed patients who 9 responded well would not have responded to such 10 an ad. 11 Q. Why? 12 A. Because they were being taken 13 care of by Amytryptiline or Imipramine. 14 Q. Let me ask you this, Doctor 15 Slater: Is it your testimony here today that 16 when you were the clinical monitor of Fluoxetine 17 Hydrochloride responsible for drafting these 18 protocols and reviewing the clinical case report 19 forms in preparing data reflective of those 20 studies, that you were under the assumption that 21 the patients who were being treated were patients 22 who had not responded to conventional standard 23 antidepressant therapy that was available at the 24 time? Page 400 1 A. I was under the impression 2 that many of the patients that we would recruit 3 would fall in that category. 4 Q. What percentage of those 5 patients were you assuming? 6 A. I have no idea. 7 Q. Was it twenty-five percent? 8 MR. ARMSTRONG: Objection. He just 9 got through saying I have no idea, now you say 10 was it twenty-five percent. The question is 11 redundant and it's been asked and answered. 12 MR. SMITH: Is that an objection? 13 MR. ARMSTRONG: It certainly is. 14 Q. Was it -- you said many of the 15 patients had not responded to conventional 16 medication, correct? 17 A. Yes. 18 Q. Was it more than half the 19 patients? 20 A. I don't have any idea of the 21 quantitation. 22 Q. Then how can you say it was 23 many of the patients if you don't have any idea? 24 A. Because many is a very general Page 401 1 term. 2 Q. That's all my inquiry then is, 3 was it as many to you, twenty-five percent, fifty 4 percent or seventy-five percent, Doctor Slater? 5 A. I think the implication of my 6 answer is that I don't know in detail, but that 7 it was probably lots of them, many of them. 8 Q. More than half? 9 A. Perhaps. Does that make you 10 happy? 11 Q. It's not a question of whether 12 I'm happy or not, I'm here to get some 13 information concerning the clinical trials in 14 this drug. And you were the clinical monitor for 15 a period of time? 16 A. Yes. 17 Q. And apparently your judgment 18 was relied upon on whether or not to continue 19 these clinical trials, correct? 20 A. Yes. 21 Q. Now, my question to you is: 22 Based in that, on that preface, can you give us 23 any better recollection or judgment with respect 24 to the percentage of patients that had not Page 402 1 responded to conventional antidepressant therapy 2 other than many? 3 MR. ARMSTRONG: Objection, asked and 4 answered for about the fourth or fifth time. 5 MR. LORE: Lilly joins in that 6 objection. 7 Q. Go ahead and answer that, 8 they're just making an objection. 9 A. I've answered it several 10 times. I think that it depended on the nature of 11 the clinic in which the study was done. In some 12 clinics, practically all the patients were drug 13 resistant or so-called drug resistant, and 14 perhaps some of them, a smaller portion, I don't 15 think this was necessarily a standard population 16 that one could say is ten percent, twenty 17 percent, fifty percent. 18 Q. Okay. 19 MR. ARMSTRONG: He wants to know if 20 you can quantify it in terms of percentage. If 21 you can, do it, if you can't, let him move on. 22 A. Let's move on, please. 23 Q. You can't do that? 24 A. No. Page 403 1 Q. You said that in some clinics 2 there was a much higher percentage of non -- can 3 we call them nonresponders to conventional 4 medications? 5 A. Yes. 6 Q. In some clinics it was almost 7 virtually all of the patients were nonresponders. 8 A. Yes. 9 Q. Was Doctor Fabre's clinic one 10 in which most of the patients were nonresponders 11 to prior medication? 12 A. I don't think so. 13 Q. Was Doctor -- 14 A. I would like to repeat, once 15 again, that my responsibility was to find out on 16 the basis of a relatively small study whether it 17 was possible that Fluoxetine was a drug worthy of 18 a wider clinical trial. I had to make a judgment 19 based on a relatively small number of patients, 20 many of whom were drug resistant. I made the 21 judgment that this compound was worthy of further 22 clinical trial, and many years of clinical 23 experience indicates that I was not very far from 24 wrong. Page 404 1 MR. ARMSTRONG: From wrong or right? 2 A. From right. 3 Q. Was Doctor Masco's clinic one 4 in which there was a high percentage of 5 nonresponders? 6 A. Doctor Masco was not one of my 7 investigators, he came on after I retired. 8 Q. He started when you were still -- 9 A. No, he was recruited at that 10 time. 11 Q. At the time he was recruited, 12 was his clinic going to be one where there was a 13 high percentage of nonresponders to prior 14 medication? 15 A. I'm trying to recall. 16 MR. ARMSTRONG: If you don't know, you 17 tell him you don't know. 18 A. I really don't know. 19 Q. I'll give you some time to try 20 to recall. 21 MR. ARMSTRONG: No, that's not 22 necessary. The witness has given you an answer, 23 he says he doesn't know. 24 MR. SMITH: He said I'm trying to Page 405 1 recall. I was simply trying to pause for a 2 minute to give the man the opportunity to answer, 3 and you interject don't tell him if you don't 4 remember. 5 MR. ARMSTRONG: That's right. You 6 don't want answers which are not based on the 7 witness' knowledge, do you? 8 MR. SMITH: I want to give him the 9 opportunity to reflect on the question before he 10 answers the question. He said I'm trying to 11 recall. 12 MR. ARMSTRONG: Do you need any more 13 time to reflect on that question? 14 A. After thinking over what I 15 knew about Doctor Masco's clinic, I really don't 16 know how many of the patients had been on how 17 many drugs before he would enroll them in this 18 study. 19 Q. Where was Doctor Masco's 20 clinic again? 21 A. New Port Richey, Florida. 22 Q. Where is that from here? 23 A. North. New Port Richey is 24 about ten or fifteen miles north of Tarpon Page 406 1 Springs, which is about five miles north of 2 Clearwater, which is on Tampa Bay, okay. 3 MR. LORE: Paul, I'm sorry, but I need 4 to take a break. 5 (A SHORT RECESS WAS TAKEN.) 6 MR. SMITH: I have been advised by 7 counsel for Lilly that he has an announcement to 8 make one hour before our departure concerning the 9 identity of the individuals whose name had been 10 redacted for whom Lilly was checking on. 11 MR. LORE: In fact this morning we did 12 get someone to check on this, disrupting their 13 Saturday morning, but -- 14 MR. SMITH: Yes, it's my understanding 15 that Lilly is closed on Saturdays and it's 16 impossible to get in. 17 MR. LORE: That being the case, on 18 page forty-five, the first name that has been 19 masked, the first name of their name is there, 20 Hy, H-Y. The second name is Denver, D-E-N-V-E-R, 21 at Key Biscayne. That may have been already 22 identified. The last name that was masked on 23 that page we checked, and in fact that is a 24 nonpivotal investigator who we discussed who was Page 407 1 working on the intention myoclonus patients. On 2 page forty-six, the entry 6-29-79, the second 3 name that has been masked in that entry, the 4 first name appears Thomas, the second name is 5 Bann, B-A-N-N. 6 THE WITNESS: No, one N. 7 MR. LORE: I'm sorry, B-A-N. The last 8 name that was masked on that page that entry is 9 Hy Denver, D-E-N-V-E-R. On page forty-seven, the 10 second name masked on the first line is again the 11 investigator who was a nonpivotal investigator 12 who was doing the intention myoclonus patients. 13 And then the next to last name that was masked, 14 starting with the entry 7-20-79, is also that 15 same investigator, nonpivotal investigator. 16 MR. SMITH: I was looking for my copy. 17 THE WITNESS: Is this your copy? 18 MR. SMITH: Here it is. 19 MR. LORE: Page forty-eight, the first 20 name that's been masked is Dan, D-A-N, in 21 Nashville. The last name masked of the names 22 masked on that entry is again Dan, D-A-N. And 23 then turning to page fifty-three, the name that 24 is masked on that page is the intention myoclonus Page 408 1 investigator, and likewise on page fifty-four, 2 the name that's masked on that page is again the 3 intention myoclonus investigator. All other 4 names masked in the exhibit that has been marked 5 as Plaintiffs' 2 have been verified as nonpivotal 6 investigators. 7 MS. MORTIMER: But for the ones that 8 were discussed within the deposition where Lilly 9 relates they were mistakenly redacted. 10 MR. LORE: Right, that's true. During 11 the course of the deposition, there was 12 discussion about the identities of people that 13 were masked who were in fact pivotal 14 investigators. In each instance, that name was 15 given. 16 MS. MORTIMER: I'll make a request to 17 Doctor Slater's counsel to produce a copy of the 18 diary that has, according to your argument, the 19 necessary redactions. We're obviously going to -- 20 and do want the unredacted diary, however I 21 believe -- and I believe you would agree we're 22 entitled to one that's properly redacted in your 23 view. So instead of having one that we have to 24 keep looking at the record to find out what is or Page 409 1 is not disclosed, I think we're entitled to one 2 properly redacted in your opinion. 3 MR. ARMSTRONG: I'll take your request 4 under advisement. 5 MS. MORTIMER: I appreciate it. 6 MR. SMITH: Mister Lore, we appreciate 7 that announcement, however that announcement in 8 our judgment has come too late. I do not at this 9 time have time to discuss with the witness those 10 individuals who you now, forty-five minutes prior 11 to our agreed departure date, identified. And we 12 will resume this deposition at a later date for 13 purposes of at least discussing with the witness 14 those individuals who you now just revealed. 15 MS. MORTIMER: We join in that 16 objection. 17 MR. LORE: I would say I think you 18 have forty-five minutes and I think you can 19 probably get through all of them in about five 20 minutes because we only identified actually five. 21 MS. MORTIMER: Mister Smith, his 22 questioning with that doesn't mean that I don't 23 have questioning, and this subpoena was not just 24 for this date and yesterday, and it was Page 410 1 understood and agreed by counsel that it may be 2 necessary to go more than two days on this. So 3 even if Mister Smith has questions doesn't mean 4 that I don't. 5 MR. LORE: What you're saying I would 6 have to direct to counsel for Doctor Slater. It 7 would be Lilly's position that two days is more 8 than sufficient. 9 MR. ARMSTRONG: We'll deal with that 10 after we've taken under advisement other matters, 11 and if and when you undertake to resume the 12 deposition. 13 Q. Doctor Slater, was there ever 14 any situation where in the clinical studies in 15 which you participated in or assisted in drawing 16 the protocols, was there ever a situation where 17 it was contemplated that the drug Fluoxetine 18 Hydrochloride would be discontinued by virtue of 19 patients becoming a suicidal risk during the 20 study? 21 A. No. 22 (PLAINTIFFS' EXHIBIT NO. 12 WAS 23 MARKED FOR IDENTIFICATION AND 24 RECEIVED IN EVIDENCE.) Page 411 1 Q. I'm going to hand you a 2 document marked Exhibit 12, Doctor Slater, and 3 ask you to review that document. 4 A. In the interest of time, I'm 5 just glancing at this and I'm not examining it in 6 great detail. Yes. 7 Q. They're going to want to look 8 at it before I ask you questions about it. 9 Doctor, I'm going to need to come over and look 10 at this with you since this is the only copy I 11 have. It appears to be Exhibit No. 12, a letter 12 authored by you dated August 3, 1979, is that 13 correct? 14 A. Yes. 15 Q. And it's a letter to Mister 16 Lawrence Gosenfeld? 17 MR. ARMSTRONG: Doctor. 18 Q. Doctor Lawrence Gosenfeld, 19 D.O., correct? 20 A. Yes. 21 Q. And was Doctor Gosenfeld an 22 investigator hired by Lilly to do clinical 23 studies in connection with Fluoxetine? 24 A. Yes. Page 412 1 Q. Do you recall talking with 2 Doctor Gosenfeld? 3 A. Yes. 4 Q. And was Doctor Gosenfeld -- 5 did you visit Doctor Gosenfeld in Los Angeles? 6 A. Yes. 7 Q. On how many occasions? 8 A. I think one. I'm not sure, 9 but I remember one visit. 10 Q. Did Doctor Gosenfeld complete 11 clinical trials as far as you know -- 12 A. No. 13 Q. -- that were started? 14 A. No. 15 Q. Why? 16 A. I'm not sure exactly why. He 17 did two patients, and stopped. 18 Q. Is Doctor Gosenfeld the 19 physician that you reference in your diary about 20 the patient who had schizo-effective disorder and 21 the patient whose study was a simple failure? 22 A. Yes. 23 Q. Of those two patients that 24 Doctor Gosenfeld studied, was he treating Page 413 1 patients under IND protocol number fourteen? 2 A. That's my assumption. 3 Q. Is that a valid assumption 4 based on the fact that you enclosed a copy of IND 5 fourteen with your letter? 6 A. Yes. 7 Q. And did you work on protocol 8 number fourteen, Doctor Slater? 9 A. Yes. 10 Q. And did you prepare protocol 11 number fourteen? 12 A. I don't remember in detail, 13 but I was certainly involved in its preparation. 14 Q. Were you intimately involved 15 in its preparation? 16 A. I think so. 17 Q. Was there anybody at Eli Lilly 18 and Company that devoted more time to the 19 preparation of protocol number fourteen than 20 yourself? 21 A. I don't think so, probably 22 not. 23 Q. What other individuals 24 participated at Lilly in the preparation of Page 414 1 protocol number fourteen? 2 A. I don't remember. 3 Q. Do you remember anybody whose 4 assistance you elicited in preparing protocol 5 number fourteen? 6 A. I can answer that in a generic 7 way. People in the medical affairs group who 8 were responsible for reporting to the FDA would 9 have gone over this to make sure that it met -- 10 Q. FDA requirements? 11 A. FDA requirements. 12 Q. Anybody else who had 13 substantive input to you in the medical division? 14 A. Perhaps Doctor Barnett, I 15 don't remember. 16 Q. What's Doctor Barnett's 17 training? 18 A. Doctor Barnett was a trained 19 psychiatrist who had done research in 20 antidepressant drugs and was responsible for the 21 clinical trial of Nortriptyline, which was a 22 marketed antidepressant. 23 Q. Was protocol number fourteen a 24 protocol that you designed from scratch or did Page 415 1 you take a previous protocol and add and delete 2 to that previous protocol to come up with the 3 final protocol fourteen? 4 A. I don't remember, but I 5 suspect it was a modification of previous 6 protocols. 7 Q. And would it have been a 8 modification of previous protocols used in 9 connection with Fluoxetine or Nyzoxin? 10 A. Perhaps Fluoxetine. 11 Q. Do you recall the number of 12 the protocol -- 13 A. No. 14 Q. -- that you used to amend to 15 get to protocol number fourteen? 16 A. No. 17 Q. But you were the individual 18 that devoted the most time at Lilly to the 19 preparation of protocol number fourteen? 20 A. Probably. 21 Q. But Doctor Gosenfeld was to 22 administer Fluoxetine under the guidelines 23 provided by protocol number fourteen? 24 A. Yes. Page 416 1 Q. Were there other physician 2 investigators who administered Fluoxetine in 3 accordance with protocol number fourteen? 4 A. Probably not, since protocol 5 fourteen specifies that Doctor Gosenfeld will be 6 the investigator. 7 Q. Well, could you have -- you 8 mean protocol number fourteen could have been a 9 multi-site protocol where you would have had 10 fourteen for Gosenfeld, might have had fourteen 11 for Masco, fourteen for Fabre. You follow what 12 I'm saying, in other words the fact that 13 Gosenfeld's name is on there doesn't mean he was 14 the only one that was doing fourteen, does it? 15 A. I'm not sure. 16 Q. Well, it's not conclusive that 17 he was the only one that was doing fourteen, is 18 it? 19 A. No. 20 Q. Did Doctor Masco do fourteen? 21 A. I don't know. 22 Q. Did Fabre do fourteen? 23 A. I don't know. 24 Q. Well, fourteen is a Fluoxetine Page 417 1 versus Imipramine study, isn't it? 2 A. Yes. 3 Q. Fabre was doing a Fluoxetine 4 versus Imipramine study, wasn't he? 5 A. Yes. 6 Q. That's a double-blind study, 7 is it not? 8 A. It's what? 9 Q. A double-blind study, is it 10 not? 11 A. No. 12 Q. It's a single-blind study? 13 A. Yes. 14 Q. What there tells you it was a 15 single-blind study? 16 A. The fact that the material is 17 labeled. 18 Q. Oh, the fact that -- well, it 19 doesn't have a labeling for Imipramine, does it? 20 A. No. 21 Q. So it's going to be blinded 22 only to Fluoxetine versus placebo? 23 A. My inference at this point is 24 that all we supplied him was Fluoxetine and Page 418 1 placebo, and that we would supply the other 2 materials at a later date. But that we made 3 provision for the protocol to supply -- to cover 4 the later phase. 5 Q. All right. 6 A. But it's an open-label study, 7 comparing four sixty-eight was Fluoxetine and 8 forty-four sixty-nine was placebo. 9 Q. When you say open-label, you 10 mean? 11 A. The physician knew what 12 medication he was giving the patient. 13 Q. But you don't know of anybody 14 else that did a protocol number fourteen study? 15 A. No. 16 Q. You had criteria for inclusion 17 and exclusion in this study, did you not? 18 A. Yes. 19 Q. That study excluded 20 individuals who were serious suicidal risks, did 21 it not? 22 A. Yes. 23 Q. And does that study require 24 that patients be included who were not responders Page 419 1 to other conventional antidepressant therapy? 2 A. No. 3 Q. Does that protocol exclude 4 patients who were responders to other 5 antidepressant therapy, conventional 6 antidepressant therapy? 7 A. No. 8 Q. You weren't supposed to have, 9 in common lay terms, individuals in the study who 10 were serious suicidal risk, correct? 11 A. Correct. 12 Q. Who was going to make the 13 determination with respect to whether or not a 14 patient was going to be a serious suicidal risk? 15 A. The psychiatrist responsible 16 for doing the study. 17 Q. Why, Doctor Slater, as the 18 clinical monitor of this Fluoxetine study and the 19 author of this protocol, did you exclude patients 20 who were suicidal risks from the study? 21 A. I don't remember, but I would 22 assume that this was a dangerous group of 23 patients, and this was an untried drug, and if 24 such patients did fail to respond to the Page 420 1 medication, they might go ahead and commit 2 suicide. 3 Q. Well, then, did you go ahead 4 and presuppose when you entered the clinical 5 trials that you would have some patients who 6 would not respond to the medication? 7 A. Yes. 8 Q. Did you presuppose that some 9 of those patients would become seriously suicidal 10 while participating in the trial? 11 A. No, I assumed that some of the 12 patients -- some of the candidates might be 13 seriously -- might have a characteristic syndrome 14 of depression which includes suicidal ideation. 15 Q. And that's why you excluded 16 those patients in participating in this study? 17 A. Yes. 18 Q. That brings me to my question, 19 Doctor, that I asked you earlier. Why did you 20 provide under nine, criteria for discontinuing 21 drug, that the drug may be discontinued if 22 serious risk of suicide develops? 23 A. For obvious reasons, because 24 that would be a very bad side effect. Page 421 1 Q. Did you expect that serious 2 suicidal risk might be a side effect that would 3 appear during treatment with Fluoxetine? 4 A. No. 5 Q. Then why did you place that as 6 an item for discontinuing the drug? 7 A. Because I didn't want anybody 8 to commit suicide while on the drug. 9 Q. What made you think that an 10 individual might commit suicide while on the 11 drug? 12 A. Because mentally ill patients 13 do this sort of thing. 14 Q. You would end with that 15 presupposition, that there might be some mentally 16 ill patients that would commit suicide? 17 A. Yes. 18 Q. So if they were taking 19 Fluoxetine and they became a serious suicidal 20 risk, it was required that the investigator 21 discontinue the Fluoxetine, is that right? 22 A. Yes. 23 Q. So you were minimizing the 24 risk of suicide in that protocol in two matters, Page 422 1 weren't you? 2 A. Yes. 3 Q. Number one, by excluding 4 individuals who were suicidal, right? 5 A. Uh-huh. 6 Q. Is that a yes? 7 A. Yes. 8 Q. And number two, by 9 discontinuing the drug if the patient becomes 10 suicidal while receiving Fluoxetine treatment, 11 correct? 12 A. Yes. 13 Q. Do you know of anything else 14 that could have been done in drafting a protocol, 15 Doctor Slater, that would have helped in reducing 16 the chance that you would find somebody who 17 became suicidal on Fluoxetine treatment other 18 than what's provided in protocol number fourteen? 19 MR. LORE: I object to the form of the 20 question as not being capable of being responded 21 to. Doctor, if you can understand it, answer 22 Mister Smith. 23 MR. SMITH: Are you giving him 24 instructions -- Page 423 1 MR. LORE: I'm not instructing him not 2 to answer, but I'm objecting to the form of the 3 question. 4 MR. SMITH: Then why are you giving 5 the witness instructions? 6 MR. LORE: I'm not, I'm objecting to 7 the form of the question. 8 MR. SMITH: You're not even his 9 lawyer. 10 MR. LORE: I'm a party to this action, 11 I can make objections, and that's my judgement. 12 MS. MORTIMER: You can't instruct the 13 witness. 14 MR. LORE: I'm not instructing the 15 witness. 16 MR. SMITH: You said Doctor, if you 17 can understand the question, you can answer the 18 question. 19 MR. LORE: All right. I withdraw 20 that, Doctor. 21 MR. ARMSTRONG: I think it's 22 ridiculous to suggest that any counsel or anybody 23 sitting around a deposition table could not 24 counsel a witness that if he doesn't understand a Page 424 1 question he shouldn't answer it, whether he's 2 appeared as counsel for the witness or not, and 3 I'm sure counsel, Mister Smith, you don't want 4 this witness to understand -- to answer a 5 question he didn't understand because you so 6 advised him at the beginning. 7 MR. SMITH: That would be true unless 8 I felt as I do here, that what counsel is 9 actually doing is suggesting to the witness the 10 appropriate way to answer the question by saying 11 I don't know. 12 MR. ARMSTRONG: I think. 13 MR. SMITH: Or I don't understand your 14 question. 15 MR. ARMSTRONG: 16 MR. ARMSTRONG: I think you have had 17 sufficient opportunity to observe this witness to 18 conclude that he has a mind of his own and he can 19 handle himself, and if he can answer the 20 question, he will, and if he can't, he won't. 21 MR. SMITH: Then I don't see why 22 counsel for Lilly feels the need. 23 MR. ARMSTRONG: Why did you repeat the 24 instruction two times, at the beginning of this Page 425 1 session and at the beginning of yesterday's 2 session? 3 MR. SMITH: Because I couldn't think 4 of any other way to start it, it's verbage on my 5 part. 6 MR. ARMSTRONG: It's a limb flick. 7 THE WITNESS: An empty gesture, 8 perhaps. 9 A. Let me see if I can understand 10 the question by repeating it. You asked me 11 whether excluding the patients who initially 12 showed serious risk of suicide, and by stopping 13 as soon as the patients showed any indication of 14 suicidal risks, were the only ways that I could 15 think of of finding out whether -- what was I 16 going to find out? 17 Q. It's the only way to ensure 18 that you don't have a situation that occurs where 19 a patient becomes suicidal during the clinical 20 trials. And my question is: Can you think of 21 any other way other than the manner in which it 22 was done in protocol number fourteen? 23 A. Yes. I think you could 24 specify that patients should be watched Page 426 1 twenty-four hours a day by full-time nurses who 2 would be with the patient every minute of the 3 day, and that would prevent the patient from 4 committing suicide. Do you consider this a 5 realistic situation? 6 Q. I'm not talking about 7 preventing the patient from committing suicide, 8 Doctor. 9 A. That's what you said. 10 Q. I'm talking about ensuring 11 that a patient does not become suicidal or 12 develop suicidal tendencies during the period of 13 therapy with Fluoxetine. 14 A. No. 15 Q. Did you, and I'll ask you 16 again, consider discontinuing the drug because of 17 serious suicidal risks -- if a patient developed 18 suicidal risk as being something that should be 19 done in protocol number fourteen? 20 A. Yes. 21 Q. Did you draw any protocols for 22 any inpatient studies? 23 A. This was an inpatient study. 24 Q. It was? Page 427 1 A. Yes -- is it, I think maybe 2 I'm wrong, let me check it. Initially it was an 3 inpatient study. 4 Q. I don't remember either, 5 that's why I was going to look at it too. It 6 says inclusion, outpatient. 7 A. No, I guess not. 8 Q. So protocol number fourteen 9 was an outpatient study? 10 A. Uh-huh. 11 Q. Is that a yes? 12 A. Yes, this was as outpatient 13 study, I'm sorry. 14 Q. Do you know if there was ever 15 a final report done in connection with protocol 16 number fourteen? 17 A. Yes. 18 Q. How do you know that? 19 A. I think we submitted the data 20 on the two patients that we received under this 21 to the FDA. What do you mean by a final report? 22 MR. LORE: I was going to say -- 23 Q. In each of the protocols that 24 we have seen so far, Doctor Slater, that have Page 428 1 been provided to us in discovery, final reports 2 in connection with each of the protocols. 3 A. Uh-huh. 4 Q. And my question is: Do you 5 know whether or not a final report was done? 6 A. No, I don't know. 7 MR. ARMSTRONG: Can I -- appropo to 8 that, is that exhibit you've been showing the 9 witness, was that obtained in production in the 10 course of this litigation or some other 11 litigation or do you know? 12 MR. SMITH: I don't know. 13 MR. ARMSTRONG: Does anybody at the 14 counsel table know? 15 MS. MORTIMER: No. 16 MR. ARMSTRONG: Nobody knows, is that 17 what you're saying? 18 MS. MORTIMER: There have been 19 thousands of documents produced in many different 20 cases in case. 21 MR. ARMSTRONG: You have no system of 22 marking them so that you can tell which 23 litigation they are produced in? 24 MS. MORTIMER: I believe that Lilly Page 429 1 had a system where they -- 2 MR. ARMSTRONG: My question, if you 3 don't mind, is do you? 4 MS. MORTIMER: I'm not asking the 5 questions, and I'm not using the exhibit, I don't 6 think I'm the right person to ask that question 7 to. Perhaps you can ask Mister Smith. 8 MR. ARMSTRONG: I'm asking it of 9 plaintiffs' counsel collectively. 10 MR. SMITH: My answer is I don't know 11 the original source, whether or not this was 12 produced in other litigation. My judgment is 13 it's probably not been produced in other 14 litigation by Lilly or they would have marked it. 15 MS. HUFF: And my question is whether 16 fourteen is the one that was sent to this 17 investigator. Just because it was stapled 18 together, doesn't mean it necessarily was. 19 MR. ARMSTRONG: That's what I'm trying 20 to get at. 21 THE WITNESS: That's another thing 22 that I can't -- 23 MR. ARMSTRONG: Did the reason that -- 24 see, one of the things that's hampered us, Paul, Page 430 1 is we -- you're asking questions about exhibits 2 that we don't have before us, so we as counsel 3 can't look at them, there's only one copy of that 4 in the room. So if we can take a minute so we 5 can take a look at it, too. 6 MR. SMITH: Sure, or we can -- I just 7 had one copy, and I didn't have an opportunity to 8 make another copy. You all have been having 9 problems getting phone calls back to Lilly and 10 I've had my own problems, too. The reason we 11 made the assumption -- 12 THE WITNESS: This is a draft and not 13 a final copy. 14 Q. Where does it say draft? 15 A. It says I am submitting this 16 draft to our protocol review committee. 17 Q. All right. 18 A. So this was not the -- and ask 19 him to make suggestions. We were not sending 20 anything to anybody. 21 Q. You sent it to Doctor 22 Gosenfeld? 23 A. All I'm saying is that I'm 24 sending him a draft of a protocol. This draft to Page 431 1 our protocol review committee with the reasonable 2 hope they will not ask for major changes. I'm 3 discussing methods by which we could extend same 4 to cover a period of three to six months, could 5 you let me know your comments and suggestions. 6 MR. ARMSTRONG: Could you ask him, 7 Paul, if you don't mind, whether he knows whether 8 or not the draft which is attached is either a 9 draft or the final version of the protocol that 10 was sent to the doctor for completion. 11 Q. Doctor, the reason we assumed 12 that what we had attached to this letter is by 13 virtue of the fact that this letter is dated 14 August 3, 1979 and is directed at Doctor 15 Gosenfeld, and the fact that IND protocol number 16 fourteen here is directed to Doctor Gosenfeld and 17 is also dated August 3, 1979. Does that -- with 18 that explanation, does that give you any 19 assistance that you might need in answering 20 questions concerning that document? 21 A. Yes. 22 Q. Thank you. You don't have any 23 independent recollection that there were any 24 changes made in protocol number fourteen, do you? Page 432 1 A. I don't even have any 2 recollection of whether protocol fourteen was 3 actually approved. 4 Q. All right. You think it 5 wasn't approved? 6 A. I know that Doctor Gosenfeld 7 did obtain material. 8 MR. ARMSTRONG: Did or did not? 9 THE WITNESS: Did, ultimately. 10 Q. Did you ever send a physician 11 actual drugs without there being approval of the 12 protocol? 13 A. No, but I don't know what -- I 14 have not seen documents -- I have not seen a 15 letter or communication from me saying I am 16 sending you a drug. 17 Q. You know you sent him drugs, 18 though, don't you? 19 A. I know I sent him drugs, and I 20 know that I sent him a draft of a protocol, but 21 the two are different things. 22 Q. Doctor Gosenfeld was the one 23 that was doing the study in connection with the 24 two individuals? Page 433 1 A. If we go back in time, Doctor 2 Gosenfeld was the guy who would be doing the 3 study, not was doing the study. Is that clear? 4 Q. Did he do more than one study -- 5 no, it's not. 6 A. At the time this letter was 7 written, and shortly thereafter, Doctor Gosenfeld 8 had done no study. 9 Q. All right. 10 A. Now you have more documents on 11 this than I. 12 Q. You mention in your entry of 13 January 29, 1979, that is page, what, thirty-one 14 of your journal, had just returned, which is 15 Exhibit 2, you say I have just returned from a 16 trip to west coast and Houston to set up trials 17 of Fluoxetine. Would that trip to the west coast 18 that you're reporting be the trip to Los Angeles, 19 California where you talked to Doctor Gosenfeld? 20 A. Yes. 21 MR. ARMSTRONG: Are you referring to 22 page thirty-one, Counsel? 23 MR. SMITH: Yes. 24 Q. Now, do you know whether Page 434 1 Doctor Gosenfeld submitted this protocol to the 2 institutional review committee? 3 A. I suspect he did. 4 Q. Did you and he discuss your 5 submission of this document to the institutional 6 review committee? 7 A. I don't remember. 8 Q. What hospital was he using, 9 Brentwood V.A. Hospital? 10 A. Yes. 11 Q. In your excluding patients 12 with serious suicidal risk in protocol number 13 fourteen, did you consult with psychiatrists to 14 get that exclusion or was this something that you 15 were able to do based on your experience? 16 A. I don't remember. My guess 17 would be that it was something that was in the 18 protocol that I was modifying, but I'm not sure. 19 Q. In that portion of the 20 protocol that calls for discontinuing the drug if 21 serious risk of suicide develops, did you consult 22 with any psychiatrist concerning that language? 23 A. I don't remember. 24 Q. Was this something that you Page 435 1 would have brought forth from another protocol? 2 A. I think it's probably brought 3 forth from previous protocols, but I can't swear 4 to that. 5 Q. Do you know if Doctor Fabre 6 did protocol number nineteen under your 7 direction? 8 A. No. I don't know the number. 9 Q. Does protocol number fourteen 10 or did any protocols that you recall address the 11 question as to whether or not a patient had 12 received psychotherapy in the conventional 13 psychoanalysis method? 14 A. I don't remember, but I don't -- 15 I do not remember whether any of the protocols 16 made any comments about the extent, nature or 17 duration of psychotherapy that patients may have 18 received. 19 Q. What was your impression or 20 what's your recollection concerning whether or 21 not the patients in the clinical trials had 22 received psychotherapy where they had been 23 treated by counseling for their depression? 24 A. What is my recollection, none. Page 436 1 Q. You didn't consider that 2 significant in antidepressant medication, whether 3 or not the patients had received psychotherapy 4 via counseling? 5 A. I didn't say that. All I said 6 is I have no recollection of having specified the 7 amount or nature of the psychotherapy the 8 patients may have received. 9 Q. Do you recall whether or not 10 it was significant to you at the time, whether or 11 not the patient had had psychotherapy? 12 A. No. 13 Q. Did you or do you have an 14 impression concerning whether or not a patient is 15 at a greater or lesser risk of becoming less 16 depressed on psychopharmacological therapy if 17 they have received psychotherapy such as 18 counseling without drugs? 19 A. You'll have to repeat the 20 question, I don't think it makes any sense. 21 (THE COURT REPORTER READ BACK THE 22 REQUESTED TESTIMONY.) 23 A. Isn't that a nonsequiter? 24 Q. Are you having problems Page 437 1 answering that question, Doctor Slater? 2 A. The question says have you an 3 impression on whether the patient is going to 4 respond on drug, whether the patient has been -- 5 had psychotherapy with or without drug. 6 Q. Without drug. In other words, 7 if a patient had been receiving counseling where 8 they went to a psychiatrist or psychologist for 9 their depression, and then entered a clinical 10 trial, versus a patient who had not received any 11 counseling and went into any trial, did you make 12 any judgment at the time with respect to whether 13 or not any one of the two sets of patients had 14 any risk or chance of becoming more or less 15 depressed? 16 A. At the time, I didn't make 17 that judgment. 18 Q. Have you now? 19 A. I think if a patient has 20 received psychotherapy and responds, then the 21 patient is not going to be a candidate for drug, 22 and therefore a patient who responds readily to 23 psychotherapy, said patient not receiving the 24 psychotherapy would probably be more responsive Page 438 1 to drug. But that's just a statistical judgment 2 rather than a scientific one based on sound 3 psychiatry. 4 Q. Well, I guess my question is: 5 At the time, was it your impression as the 6 clinical monitor that the subjects of the 7 clinical trials were probably patients who had 8 been subject to psychotherapy, that psychotherapy 9 had been ineffective? 10 A. Yes. 11 MR. SMITH: It's 4:00. What do you 12 want to do? 13 MR. ARMSTRONG: Go. It's not what we 14 want to do, it's what Mary has to do. 15 MR. SMITH: We'll adjourn this 16 deposition, then, because I am not completed with 17 my questioning. 18 MS. MORTIMER: On behalf of the 19 plaintiffs in the Fentress case, we have not had 20 an opportunity to do any questioning, and we 21 reserve our right to continue this deposition and 22 question the doctor on our own right. 23 (THE WITNESS WAS EXCUSED.) Page 439 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 DOCTOR I.H. SLATER 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 6TH DAY OF 19 FEBRUARY, 1994. 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 440 1 2 3 E R R A T A S H E E T 4 5 COMMONWEALTH OF KENTUCKY ) : SS 6 COUNTY OF JEFFERSON ) 7 8 9 I, I. H. SLATER, THE UNDERSIGNED 10 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 11 OF MY DEPOSITION AND WITH THE CHANGES NOTED 12 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 13 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 14 THE 28TH AND 29TH OF JANUARY, 1994 AT THE TIME 15 AND PLACE STATED THEREIN. 16 PAGE NO. LINE NO. CHANGE REASON Page 441 1 PAGE NO. LINE NO. CHANGE REASON 2 3 4 5 6 7 8 _____________________________ 9 I. H. SLATER 10 SWORN TO AND SUBSCRIBED BEFORE ME THIS 11 _____ DAY OF __________, 1994. 12 _____________________________ NOTARY PUBLIC, STATE OF 13 KENTUCKY AT LARGE 14 Page 442 1 COMES DR. IRWIN SLATER,...........................10 2 DIRECT EXAMINATIONBY MR. SMITH:...................10 3 CONTINUING DIRECT EXAMINATIONBY MR. SMITH:.......250 4 (QUESTIONS CERTIFIED.)...........................250 5 (QUESTION CERTIFIED..............................317 6 (QUESTION CERTIFIED.)............................386 7 (PLAINTIFFS' EXHIBIT NO. 1........................56 8 (PLAINTIFFS' EXHIBIT NO. 2.......................126 9 (PLAINTIFFS' EXHIBIT NO. 3.......................243 10 PLAINTIFFS' EXHIBIT NO. 4........................328 11 PLAINTIFFS' EXHIBIT NO. 5........................330 12 PLAINTIFFS' EXHIBIT NO. 6........................352 13 PLAINTIFFS' EXHIBIT NO. 7........................357 14 PLAINTIFFS' EXHIBIT NO. 8........................362 15 PLAINTIFFS' EXHIBIT NO. 9........................370 16 PLAINTIFFS' EXHIBIT NO. 10.......................376 17 PLAINTIFFS' EXHIBIT NO. 11.......................387 18 PLAINTIFFS' EXHIBIT NO. 12.......................411 19 COMMONWEALTH.....................................440 20 COMMONWEALTH.....................................441 Page 443