00001 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 - - - 4 5 DR. MARIUS SAINES, et al., ) ) 6 Plaintiffs, ) ) 7 vs. ) No. SC 008331 ) 8 ELI LILLY & COMPANY, et al., ) ) 9 Defendants. ) ___________________________________) 10 11 12 13 14 15 DEPOSITION OF 16 LAWRENCE F. GOSENFELD, D.O. 17 LOS ANGELES, CALIFORNIA 18 MARCH 24, 1994 19 20 21 ATKINSON-BAKER, INC. CERTIFIED SHORTHAND REPORTERS 22 330 North Brand Boulevard, Suite 250 Glendale, California 91203 23 (818) 551-7300 24 REPORTED BY: JANA S. COOLEY, CSR NO. 3514, RPR 25 FILE NO: 9405426 00002 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 - - - 4 5 DR. MARIUS SAINES, et al., ) ) 6 Plaintiffs, ) ) 7 vs. ) No. SC 008331 ) 8 ELI LILLY & COMPANY, et al., ) ) 9 Defendants. ) ___________________________________) 10 11 12 13 14 15 16 Deposition of LAWRENCE F. GOSENFELD, taken 17 on behalf of Plaintiffs, at 11301 Wilshire Boulevard, 18 Los Angeles, California, commencing at 10:15 a.m., 19 Thursday, March 24, 1994, before JANA S. COOLEY, CSR 20 No. 3514, RPR. 21 22 23 24 25 00003 1 A P P E A R A N C E S 2 FOR THE PLAINTIFFS: 3 KANANACK, MURGATROYD, BAUM & HEDLUND BY: WILLIAM J. DOWNEY, III 4 12100 Wilshire Boulevard, Suite 650 Los Angeles, California 90025 5 6 FOR THE DEFENDANTS ELI LILLY & COMPANY 7 AND DISTA PRODUCTS COMPANY: 8 MORRIS, POLICH & PURDY BY: DONALD L. RIDGE, ESQ. 9 1055 West Seventh Street, 24th Floor Los Angeles, California 90017-2503 10 11 FOR LAWRENCE F. GOSENFELD, D.O.: 12 DEPARTMENT OF VETERANS AFFAIRS 13 DISTRICT COUNSEL BY: ALAN K. ACHEN, ESQ. 14 11000 Wilshire Boulevard Los Angeles, California 90024 15 16 17 18 19 20 21 22 23 24 25 00004 1 I N D E X 2 WITNESS: LAWRENCE F. GOSENFELD, D.O. 3 Examination Page 4 By Mr. Downey 6 5 EXHIBITS: Plaintiffs' 6 Number Description Page 7 1 - Notice of Deposition 87 8 2 - IND Protocol Number 17 31 9 3 - Document entitled A Controlled Study of 33 Treatment of Major Depressive Disorders 10 With Fluoxetine HC1 (110140) 11 4 - Human Studies Consent Form 35 12 5 - Human Studies Consent Form 35 13 6 - Human Studies Consent Form 35 14 7 - Letter dated December 13, 1978 39 15 8 - Letter dated February 21, 1979 46 16 9 - Memo dated April 2, 1979 47 17 10 - Letter dated June 1, 1979 49 18 11 - Letter dated January 30, 1980 52 19 12 - Fluoxetine Blood Level Transmittal Tags 55 20 13 - Letter dated April 21, 1980 57 21 14 - Address label 61 22 15 - Letter dated March 27, 1981 63 23 16 - IND Protocol Number 25 73 24 17 - Invoice dated 08/22/79 74 25 18 - Invoice dated November 5, 1979 75 00005 1 I N D E X (cont'd) 2 EXHIBITS: 3 Number Plaintiffs' Description Page 4 9 - Invoice dated January 4, 1980 77 5 6 QUESTIONS WITNESS INSTRUCTED NOT TO ANSWER: (None) 7 INFORMATION TO BE SUPPLIED: (None) 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 00006 1 LOS ANGELES, CALIFORNIA; THURSDAY, MARCH 24, 1994 2 10:15 A.M. 3 4 LAWRENCE F. GOSENFELD, D.O., 5 having been first duly sworn, was 6 examined and testified as follows: 7 8 EXAMINATION 9 BY MR. DOWNEY: 10 Q. Doctor, can you state and spell your name? 11 A. Lawrence Franklin Gosenfeld, 12 L-a-w-r-e-n-c-e F-r-a-n-k-l-i-n G-o-s-e-n-f-e-l-d. 13 Q. Doctor, my name is Bill Downey, and I 14 represent the survivors of Sorela Saines, Dr. Sorela 15 Saines, in a lawsuit against Eli Lilly & Company 16 regarding the drug Prozac. Your deposition is being 17 taken as you were a clinical trial investigator in the 18 testing of that drug. 19 Have you ever had your deposition taken 20 before, doctor? 21 A. For that -- 22 Q. For any reason. 23 A. Yeah. 24 Q. So you're well familiar with the procedures 25 in deposition? 00007 1 A. Fairly well familiar. 2 Q. Can I -- can I assume that I don't have to 3 go through the standard litany of admonitions, telling 4 you that you're under oath and all of that sort of -- 5 A. I understand that. 6 Q. Okay. Very good. If you have any 7 difficulty understanding one of my questions or you're 8 not sure what I'm getting at, please ask me to clarify. 9 I will assume if you answer a question that you 10 understood it. Is that all right? 11 A. Um-hmm. 12 Q. One of the things -- does um-hmm mean yes 13 in that? 14 A. Yes. 15 Q. One of the things that I do want to say is 16 that you're going to have to answer with words because 17 things like uh-uh and nods of the head don't get picked 18 up by the court reporter, as you are, I am sure, are 19 aware. And if you do answer in that way, myself or 20 somebody else will just make sure we have a clear 21 record; all right? 22 A. Yes. 23 Q. Good. I noticed you're taking what 24 appeared to be some medication earlier. Are you in 25 good health this morning and able to -- 00008 1 A. Um-hmm. 2 Q. Take care of your deposition? 3 A. Yeah. 4 Q. Is there any reason why we can't get your 5 best testimony this morning? 6 A. I beg your pardon? 7 Q. Is there any reason why we can't get your 8 best testimony this morning? 9 A. No. 10 Q. Doctor, let me ask you a few questions 11 about your background. I don't have a c.v. from you. 12 Perhaps you can tell me a little bit about your 13 educational background. You are not an M.D.; is that 14 correct? 15 A. I'm a D.O. 16 Q. And a D.O. is a? 17 A. Doctor of Osteopathy. 18 Q. And first of all, where did you receive 19 your undergraduate degree? 20 A. Cal State L.A. 21 Q. And when did you graduate from Cal State? 22 A. 1967 -- 1966. 23 Q. What was your degree in at Cal State? 24 A. Psychology. 25 Q. And you went -- what did you do immediately 00009 1 after graduation from Cal State? 2 A. Went to medical school. 3 Q. Where did you go to medical school? 4 A. Chicago College of Osteopathic Medicine. 5 Q. And how long a program is the osteopathic 6 medicine program? 7 A. Four years. 8 Q. Did you graduate in 1970? 9 A. 1971. 10 Q. All right. 11 A. I started in 1967. 12 Q. So you took a year off between Cal State 13 and Chicago? 14 A. Yeah. 15 Q. And you graduated with a degree of Doctor 16 of Osteopathy at that point? 17 A. Doctor of Osteopathic Medicine. 18 Q. Osteopathic medicine. 19 And did you immediately go on to further 20 specialization and training? 21 A. I went -- I went to Denver General Hospital 22 and did an R6 internship, which is general medicine, 23 emergency medicine and psychiatry. 24 Q. Just so I understand, an R6 -- 25 A. R6. Rotating 6. 00010 1 Q. And the rotating 6 internship was general 2 medicine -- 3 A. Emergency medicine and psychiatry. 4 Q. And psychiatry. All right. And how long 5 did that internship take? 6 A. Year. 7 Q. What did you do after that one year 8 internship? 9 A. I went back to Chicago and did a year at 10 Mt. Sinai Hospital in psychiatry. And I transferred to 11 the Illinois State Psychiatric Institute and finished 12 my residency and did a fellowship in research. 13 Q. Illinois Psychiatric Institute? 14 A. That's correct. 15 Q. Finished your internship? 16 A. My residency. 17 Q. Finished your residency. And then you did 18 a fellowship? 19 A. In research. 20 Q. And what was -- was there a general thrust 21 to the research you were doing? 22 A. Psychopharmacology. 23 Q. What were you researching in 24 psychopharmacology? 25 A. Lithium and Haloperidol. 00011 1 Q. Was that a single research project or were 2 there two? 3 A. No. There were several. 4 Q. Several? Were you doing clinical tests of 5 these drugs? 6 A. (Nodding.) 7 Q. Yes? 8 A. Yes. 9 Q. Were they being done under the auspices of 10 a drug company? 11 A. No. I think these were independent 12 research grants funded by the state of Illinois under 13 John Davis, who is the director of the institute. 14 Q. And the lithium research that you were 15 doing, was there more than one project where you were 16 researching lithium? 17 A. Basically one project. Looking at the rate 18 of accumulation in the red blood cell of lithium. 19 Q. So it was more along the line of a 20 pharmacokinetic -- 21 A. Exactly, yes. And I also worked with 22 Regina Casper on anorexia nervosa, some projects that 23 she was doing with Katherine Helmi from University of 24 Iowa. 25 Q. And what pharmacology was connected with 00012 1 those projects? 2 A. Basically it was behavior modification and 3 eating patterns. 4 Q. So it wasn't a pharmacology project? 5 A. No. I think they used some common 6 medication. But it was not researching medication. 7 Q. So it was essentially any medications that 8 were being used during that research were essentially 9 concomitant? 10 A. That's correct. 11 Q. And the Haloperidol research, what did that 12 involve? 13 A. That involved two groups: One that 14 received 15 milligrams of oral Haloperidol on 15 admission, and the other group that received 60 16 milligrams intramuscularly. It was called rapid 17 neuroleptization. 18 Q. Can you spell neuroleptization? 19 A. I'm not sure. 20 N-e-u-r-o-l-e-p-t-i-z-a-t-i-o-n. 21 Q. That's the intramuscular administration? 22 A. Right. The idea was to see if giving the 23 drug intramuscularly in high doses rapidly would get 24 the patient better -- would get the patient well faster 25 then using the oral dose. 00013 1 Q. And what conditions were being treated by 2 Haloperidol in this? 3 A. This was acute schizophrenia only. Acute 4 agitated schizophrenia. 5 Q. Haloperidol is a neuroleptic drug? 6 A. Yes, it is. 7 Q. After the -- how long were you there at 8 Illinois? 9 A. Let's see. Two-and-a-half years. 10 Q. Did you receive your first medical license 11 when you graduated from Chicago or after your work at 12 Denver? 13 A. No. When I graduated -- well, my first 14 medical license? I think -- I think my first license 15 was in Missouri and you didn't have to have your 16 internship to get your license there. Then my second 17 license was in Illinois where you had to have your 18 internship. And then my third license was in 19 California, but I was already finished with all my 20 education. 21 Q. So between the time -- so before you 22 actually did your internship at Denver you had a 23 license in Missouri? 24 A. That's correct. 25 Q. And then after your internship when you 00014 1 went back to Chicago, you got an Illinois license? 2 A. That's correct. 3 Q. And then when you came out here to 4 California, you got a California license? 5 A. Correct. Those are all by examination. 6 Q. Okay. Very good. Are you board certified 7 in psychiatry? 8 A. Yes, I am. 9 Q. And when did you take your psychiatric 10 boards? 11 A. As soon as I came to California. I think I 12 took part 1 in 1976 and part 2 in 1977. 13 Q. All right. So you had spent two-and-a-half 14 years in Illinois at the Illinois Psychiatric 15 Institute. What did you do immediately after that? 16 A. Came to California to the VA. 17 Q. So that was around '76 or -- 18 A. I think it was the end of '75. 19 Q. And your first position was here at the VA? 20 A. I was recruited by the research service 21 here. 22 Q. Okay. Who was head of the research 23 service? 24 A. Phil May. 25 Q. And you came out here, you joined the staff 00015 1 here, and you took your boards? 2 A. Um-hmm. 3 Q. Yes? 4 A. Yes, that's correct. 5 Q. Okay. After you took your psychiatric 6 boards in '76 and '77, did you take any boards for 7 further specialization? 8 A. No. 9 Q. And you've been employed at the VA -- 10 A. Continuously. 11 Q. Continuously since then. Yes? 12 A. Full-time. 13 Q. Full-time. All right. Were you -- strike 14 that. Let me start all over again. 15 We are going to be discussing some drug 16 protocols that you performed in the late 1970's 17 regarding fluoxetine. Do you remember those drug 18 tests, doctor? 19 A. I remember doing it, yeah. 20 Q. That's just a lawyer's question to make 21 sure you have an independent recall. 22 Doctor, let me ask you a little 23 foundational question. Did you review any documents in 24 preparation for this deposition? 25 A. No. 00016 1 Q. Did you go back through any of your files 2 or any -- 3 A. I did last year when I collected all of 4 them. 5 Q. Okay. And you collected a bunch of 6 documents pursuant to a subpoena that was -- 7 A. That's correct. 8 Q. -- last year. 9 A. Just collected everything that had to do 10 with fluoxetine. 11 Q. Very good. And you turned it over to 12 your -- to Mr. Achen's office at that time? 13 A. Actually Medical Administration Service. 14 They came and picked it up and boxed it and sealed it, 15 I guess. 16 Q. Okay. We had produced to us pursuant to 17 this subpoena a stack of documents that's about two 18 inches thick. Do you recall how many documents you 19 turned over to medical administration? And by that I 20 mean, not numbers, quantities. Was it a box full? Was 21 it three times this size, or was it about this many 22 papers? 23 A. Maybe that or a little bit more. I -- I 24 really can't say. I just packed it in a box. 25 Q. Okay. You say packed up a box. I'm 00017 1 wondering was it a full carton of documents? 2 A. No. It was not full. 3 Q. Prior to your involvement with 4 fluoxetine -- and before I do, do you recall when the 5 fluoxetine trials that you were involved in were done? 6 A. The exact dates, no. 7 Q. Do you recall generally or approximately? 8 A. I would think that it was in the early 9 eighties. Up until about 1982 I had become very ill at 10 that point. I developed bad asthma and was 11 hospitalized. And I tried to continue the study and 12 just found it was too much effort and we discontinued 13 it. We had run enough patients to make the information 14 valid, but we didn't complete the actual study. I 15 believe we were supposed to do 36 or 40 patients, and I 16 think -- I'm not sure about this, but I think we did 17 about 22. 18 Q. Did you say about 22 or 32? 19 A. 22. 20 Q. If I can refresh your memory, doctor, I 21 just -- and I don't mean to attack your memory. 22 A. That's okay. It was a long time ago. 23 Q. Right. We've got some letters here, and 24 I'll just represent we'll put these on the record later 25 on that letters between you and Eli Lilly Company from 00018 1 about 1978 up until about 1980. Does that refresh your 2 memory at all? 3 A. No. Because I may have done another study 4 for Eli Lilly. As a matter of fact, I did do another 5 study for Eli Lilly. 6 Q. Was it another fluoxetine study? 7 A. No. It was a different drug. 8 Q. And that's the study that ended in 1982 9 when you were sick? 10 A. I would have to look at the papers to be 11 able to narrow it down to a better time frame. 12 Q. What was the other drug? 13 A. I don't even remember the name of it. It 14 was -- I think it was a drug used for anxiety. We ran 15 about three patients and we found that we were getting 16 elevations in liver enzymes, and I called the sponsor 17 and they stopped the study immediately. 18 Q. Other than that short study that was 19 stopped that you think may have been an anti-anxiety 20 drug and the fluoxetine study, have you done any other 21 studies for Eli Lilly? 22 A. I don't think so. 23 Q. Again, prior to the late seventies, '77, 24 '78, '79, did you do any other studies for drug 25 manufacturers? 00019 1 A. Yes. 2 Q. What other manufacturers? 3 A. I did a study with Rorer. 4 Q. R-o-r -- 5 A. R-o-r-e-r. That was in 19 -- about 1977 6 that involved Navane and Haldol, comparing the two. I 7 did a study on Halcion for Upjohn in about 1983. 8 Recently I did a study for Johnson on a drug called 9 Respiridone that ended last year and I did a study for 10 Wyeth-Ayerst on a drug called Venlafexine. 11 Q. Can you spell that for me? 12 A. V-e-n-l-a-f-e-x-i-n-e. And that ended last 13 year. 14 Q. Any other drug studies that you've done? 15 A. Well, for -- 16 Q. For manufacturers? 17 A. No. For six years I did an NIH study for 18 lithium with Dr. Jerry Diamond at U.C.L.A. That was the 19 major part of my research while I was here. 20 Q. And when did that study take place? 21 A. That started in 1982 and ended in about 22 1987, I think. 23 Q. Other than that NIH study in the lithium 24 and the drug manufacturers studies that you've told me 25 about, are there any other drug studies that you were 00020 1 involved in? 2 A. I think I did a study with Buspar. That's 3 made by Abbott. But if I did, it was a very short 4 period of time. It was a very short study. I'm really 5 not certain about that. And that would have been in 6 the mid eighties. 7 Q. Can you spell Buspar for me? 8 A. B-u-s-p-a-r. 9 Q. What kind of a drug is that? 10 A. That's a nonaddicting, nonhabituating 11 antianxiety agent. 12 Q. Doctor, can you recall when you were first 13 approached by Eli Lilly to do clinical research for 14 them? 15 A. It must have been in the late seventies 16 sometime, but I -- I didn't even remember the 17 circumstances. 18 Q. You don't remember the circumstances. You 19 don't remember whether you contacted them or some -- 20 A. No. They contacted me. 21 Q. You were recruited. You don't remember 22 whether it was at a conference or -- 23 A. No, it was not a conference. It was a 24 representative of their company that came to me 25 specifically. 00021 1 Q. And do you know why they came to you? Was 2 it because of the drug work that you had done in 3 Chicago? 4 A. I think -- well, in Chicago and in Los 5 Angeles, also. I think they probably had talked to 6 Dr. May, and Dr. May had said that I was interested in 7 affective disorders. And so at that time it -- there 8 were just two major areas of study going on here, 9 schizophrenia and affective disorders. Dr. Vince 10 Patten is involved in schizophrenia and I was primarily 11 involved in affective disorders. And Dr. May was the 12 doctor who -- he was the chief of research. Associate 13 of chief of staff and research. 14 Q. And do you recall who you talked to 15 initially at Eli Lilly regarding doing drug trials for 16 them? 17 A. I think initially the guy's name was 18 Charlie Schultz or Shulty. And then Paul Stark. 19 Q. Was Slater in between Shulty and Stark? 20 A. Yes, he was. You're right. 21 Q. So somebody from Lilly you think Schultz or 22 Shulty made an initial contact with you -- 23 A. Um-hmm. 24 Q. -- and wanted to know if you'd be 25 interested in doing drug trials for them? 00022 1 A. He sent me a protocol to look at to see if 2 I would be interested. 3 Q. Okay. And was that a fluoxetine protocol? 4 A. No. That was something before then. 5 Q. Do you remember what it was? 6 A. (No audible response.) 7 Q. No? 8 A. No, I don't remember what it was. 9 Q. And were you interested in doing that first 10 protocol or did you say it wasn't something up your 11 alley? 12 A. No, it was something I wanted to do. 13 Q. But they decided not to have you do that. 14 A. We did that one. I thought I mentioned 15 that. 16 Q. I see. For some reason I had the idea that 17 that was later. My mistake. 18 A. The results -- we had abnormal liver 19 enzymes. 20 Q. That was the anxiety drug. 21 A. And we stopped the study. 22 Q. Okay. All right. So you did that for just 23 a very short period of time and that was the one that 24 you stopped? 25 A. Probably three months at the most. 00023 1 Q. How long after that was it before they 2 contacted you again regarding drug trials? 3 A. Maybe a year, a year-and-a-half. 4 Q. And that was the fluoxetine study? 5 A. Yes. 6 Q. When they first contacted you regarding the 7 fluoxetine study, did you have any knowledge of 8 fluoxetine at that time? Had you heard anything about 9 it? 10 A. No. 11 Q. And was that still Shulty or at that time 12 was it Slater? 13 A. I think that was Dr. Stark. It may have 14 been Slater and then Stark. But I just remember 15 Dr. Stark being involved with it. I mean, as soon as 16 you mentioned Dr. Slater's name, it rang a bell. But I 17 had forgotten totally about them. 18 Q. Okay. 19 A. So he wasn't involved that much, I don't 20 think. 21 Q. This is just a foundational question, 22 doctor. When you were doing the fluoxetine trials, you 23 had to fill out clinical report forms; correct? 24 A. That's correct. 25 Q. Do you know what happened to those clinical 00024 1 report forms, to your copies of those clinical report 2 forms after the tests? 3 A. Well, they were saved for at least three 4 years afterwards. But when we changed buildings, those 5 forms got left behind, and they were probably 6 destroyed. The reason I say probably is because I 7 looked for them and they're not there. 8 Q. Okay. I was going to say when did you 9 change buildings? 10 A. Probably about 1989. 11 Q. Okay. And you went back to your old 12 building and looked for those forms and they weren't 13 there? 14 A. That's correct. However, those same forms 15 would be available from Eli Lilly. 16 Q. Yes. Thank you. We're aware of that. 17 I have a question and I think I want to 18 direct it to your counsel. You're not under oath. But 19 I had just one question. And this is just a point of 20 procedure. You sent us some documents and you 21 indicated that they had been redacted pursuant to 5B6, 22 is that it? 23 MR. ACHEN: I think it's B4. Or possibly both 24 B6. 25 MR. DOWNEY: Can you tell me what that is 00025 1 briefly? 2 MR. ACHEN: I think those are two exemptions to 3 the Freedom of Information Act at 5 United States Code 4 552. There's a whole list of exemptions that prevent 5 the disclosure of certain information, and I believe a 6 couple of those might be B6, and I'm not sure without 7 having the documents before me, it would seem logical 8 one would be B6, which would be an unwarranted invasion 9 of personal privacy, a release of personnel or medical 10 files or similar files thereto, and the other one would 11 be the B6 exemption which prevents disclosure of trade 12 secrets or commercial information, which there may be 13 some proprietary information involved there as well. 14 MR. DOWNEY: I just wanted to get that on the 15 record. 16 MR. ACHEN: But 5 USC 552, it's right there in 17 the code. 18 Q. BY MR. DOWNEY: Doctor, I'm going to show 19 you a deposition notice. I think you've seen this. 20 And it lists the documents that we had requested on the 21 back just for housekeeping. Have you seen that 22 document before? 23 A. Yeah. 24 Q. Okay. 25 A. I'm not sure I saw this. 00026 1 Q. You probably didn't see the first page. 2 That was the notice to the attorneys. You probably saw 3 the attachment and the subpoena itself, that form 4 there. 5 A. Yeah. 6 Q. All right. And I'm going to have -- I'm 7 going to have a copy of this attached as Plaintiffs' 1 8 to this deposition. 9 The documents that we had requested, 10 doctor, and I just wanted to read them into the record, 11 were any and all records relating to clinical trials 12 conducted by you or under your supervision utilizing as 13 part of the protocol any form of the drug Prozac, 14 fluoxetine, fluoxetine hydrochloride or Lilly 110140. 15 And you did a search and you delivered all 16 documents pursuant to that request; is that correct? 17 A. Um-hmm. 18 Q. Yes? 19 A. Yes. 20 Q. And any and all correspondence by and 21 between you and Eli Lilly & Company, their agents or 22 employees regarding any form of the drug Prozac, 23 fluoxetine, fluoxetine hydrochloride or Lilly 110140. 24 And any and all correspondence between you 25 and Eli Lilly was included in the file that you turned 00027 1 over to -- 2 A. Anything that I could find. 3 Q. Very good. There's no separate 4 correspondence file that you have since found? 5 A. No. 6 Q. And the third request was for any and all 7 correspondence by and between you and the United States 8 Food and Drug Administration regarding any form of the 9 drug Prozac, fluoxetine, fluoxetine hydrochloride or 10 Lilly 110140. 11 Do you recall ever having any 12 correspondence with the FDA directly? 13 A. No. I don't recall my communicating with 14 them directly at all. 15 Q. Okay. And did you ever get any 16 communications from them regarding this trial that you 17 can recall? 18 A. No. Not that I recall. It's a long time 19 ago. 20 Q. That's fine. Of course. Of course. This 21 is not a memory test. 22 A. Okay. 23 Q. We're just asking for your best recall. 24 Number four was any and all correspondence 25 by and between you and any member of the U.S. Food and 00028 1 Drug Administration, psychopharmacological drugs 2 advisory committee regarding the drug Prozac. 3 Do you know what the psychopharmacological 4 advisory committee is, doctor? 5 A. Yes. 6 Q. And were you ever contacted by that 7 committee or any member of the committee regarding this 8 drug? 9 A. Not this drug, no. 10 Q. Hearings were held as you know regarding 11 this drug by the PDAC. Were you ever invited to those 12 hearings? 13 A. No, I was not. 14 Q. Were you ever apprised of the results of 15 those hearings? 16 A. No. 17 Q. The next request, number five, was any and 18 all class action waivers filed by you or on your behalf 19 pursuant to services consultancies or participation in 20 any form or panel convened by you or on -- or in -- it 21 says in behalf, it should be on behalf of the U.S. Drug 22 and Food Administration. 23 Do you know what the class action waivers 24 are, doctor? 25 A. No, I don't. 00029 1 Q. Number six was all records of any payments 2 made to you or on your behalf within the last 10 years 3 by or on behalf of Eli Lilly & Company, its 4 subsidiaries, affiliates, agents or employees for any 5 purpose whatsoever. 6 Now, in the documents that we received, 7 there were some bills and invoices regarding this 8 particular study. Did you also have in your possession 9 any records of payments made by Lilly for any other 10 research or anything else that you did for them? 11 A. No. The monies were sent directly to a 12 research foundation, and I essentially would authorize 13 payment of bills when they came in and then they would 14 pay them. 15 Q. Okay. And what was that research 16 foundation? 17 A. Friends Medical Science Research 18 Foundation. 19 Q. The request number seven was for any and 20 all documents evidencing ownership, share ownership or 21 other property or financial interest in Eli Lilly & 22 Company, its subsidiaries or affiliates by you. 23 A. I have none. 24 Q. Okay. No shares of stock in Eli Lilly? 25 A. None. I wish I had bought it. 00030 1 Q. Okay. And number eight was any and all 2 guidelines, manuals or instructions used or consulted 3 by you in selecting qualifying, disqualifying or 4 otherwise choosing participants in clinical trials of 5 any form of the drug Prozac. 6 And it's your representation that any 7 documents pursuant to that request are included in the 8 documents you turned over to medical administration? 9 A. That's correct. I went to the research 10 office to see what they had, and I'm not sure, but I 11 thought that in that stack were the protocols for the 12 fluoxetine study, as well as the committee evaluation 13 of it. 14 Q. I believe some of that stuff is in here and 15 we're going to identify that further along. Thank you. 16 That particular bit of housekeeping is over. 17 The next document I'd like you to take a 18 look at, doctor, is a 14-page document. It will be 19 Plaintiffs' 2. And up top it says IND Protocol Number 20 17, a Study of the Treatment of Major Depressive 21 Disorders With Fluoxetine HCL. 22 I'll represent that this is included in the 23 package of documents that were given to us. I think 24 that was the first document in that pack. And if at 25 any time you need to -- if I'm rushing you, please tell 00031 1 me to slow down. But is that the protocol as far as 2 you can tell that you worked off of in the fluoxetine 3 test that you did? 4 (Plaintiffs' Exhibit 2 was marked for 5 identification by the CSR.) 6 (Pause in the proceedings.) 7 THE WITNESS: Yes. 8 Q. BY MR. DOWNEY: Okay. Now, there's a date 9 on the bottom of that? 10 A. 5/4/79. 11 Q. Does that refresh your memory as to when 12 you were first contacted to do these trials? 13 A. Not really because this was written 5/4/79, 14 but it may well have been that we didn't start it until 15 1980. By the time you submit it and get approval, get 16 changes made. 17 Q. Now, you can't tell just from looking at 18 that document 14 years later whether that's the 19 protocol as it was -- as it was finally approved and 20 done in all its details? 21 A. It's very similar to the protocol. I 22 remember there may have been minor changes. 23 Q. Okay. This is probably a good time to ask 24 you to describe the procedure by which a protocol was 25 approved for use here at the VA. 00032 1 A. Okay. The drug company would give us an 2 outline of the protocol, the way they wanted the study 3 to be done, whether it be a placebo control, which this 4 was. Whether they compared it against another drug, 5 which I've done also. And then we would write up what 6 we thought was a reasonable protocol that would pass 7 the committee. And we submit it to the human use 8 committee. Invariably it would be bounced back with 9 changes requested. We would make the changes and, you 10 know, discuss it with Eli Lilly and if they were 11 acceptable with the changes. And then we would 12 resubmit it to the human use committee, and usually it 13 came back a second time. I think this is pretty 14 normal. Everybody's got their input. And about the 15 third time around it would get approved and we would 16 have a start date. At that point, the drug would be 17 shipped and we would start. 18 Q. Very good. So this Exhibit 2 here that 19 you're looking at, is that -- you spoke of an outline 20 of the protocol being sent to you by the drug company. 21 Is that what that is, essentially? 22 A. I think this was one that I wrote. I'm not 23 really sure. 24 Q. Okay. Well, let's -- let's move on from 25 there to Exhibit Number 3, which is a 17-page document. 00033 1 Appended to that is a three-page document. The initial 2 document is called A Controlled Study of Treatment of 3 Major Depressive Disorders With Fluoxetine HCL 4 (110140). It's in narrative form. And the last three 5 pages are an appendix entitled Consent To Participate 6 In a Study Titled, the study I just told you. And, 7 well, actually the last page is pretty much blank 8 except a -- a receipt stamp it says it was received by 9 district counsel in August of this year. 10 Do you have that document? 11 MR. RIDGE: Yes. 12 (Plaintiffs' Exhibit 3 was marked for 13 identification by the CSR.) 14 Q. BY MR. DOWNEY: That's another document. 15 If I could ask you to review that real quick. 16 We can go off the record. 17 (Recess taken.) 18 Q. BY MR. DOWNEY: Doctor, have you had an 19 opportunity to review that document in front of you? 20 A. Yes, I have. 21 Q. And what is that, doctor? 22 A. That's the pharmacological description of 23 the drug provided by Eli Lilly along with their idea of 24 the protocol and the consent form. 25 Q. Okay. That's the proposed consent form 00034 1 that they sent out? 2 A. I'm not sure. Just a moment. That's 3 the -- no. This was modified for our use because this 4 includes the article about treatment at the Brentwood V 5 A Medical Center if any harm comes to the patient. 6 Which their consent form would not have had. 7 Q. So is it safe to say that wasn't the very 8 first consent form proposed by Eli Lilly; is that 9 correct? 10 A. Well, they would have come up with their 11 consent form. What they wanted in it. And normally 12 their consent form includes information about 13 indemnification, treatment if there's a bad result. 14 However, the VA doesn't use that because they take the 15 responsibility themselves. And so we put in that 16 extra -- there's some part of the code that we put in 17 there. Under U.S. something or something, you are 18 entitled to compensation, etc. 19 Q. Okay. 20 A. Now this was early enough along that I 21 don't think we put that in. But we did put in the 22 statement as you see in the back here, I'm aware that 23 if any harm comes to me from the use of this treatment 24 I will be further treated by the Brentwood VA Hospital 25 or Medical Center. 00035 1 Q. All right. 2 A. So my guess is where this came from was 3 this was submitted for the information of the human use 4 committee for the chemical nature of the drug and the 5 results of past studies, and then the copy of the 6 consent form was appended to it. 7 Q. Okay. So that document, even though it 8 specifically talks about the test being conducted here 9 in Brentwood, was to your knowledge written by Eli 10 Lilly & Company? 11 A. Yes. 12 Q. That was not something you wrote? 13 A. Yeah. Because of the -- I may have written 14 it from something they did, but I doubt it. There'd be 15 no reason to rewrite the Bible again. 16 Q. Got you. 17 A. It's technical enough that if it was 18 rewritten, I copied it. 19 Q. Got you. 20 A. And it was copied with their knowledge. 21 Q. Okay. While we're talking about consent 22 forms, I'm going to give you three more documents, and 23 we will mark these 4, 5 and 6 in order. 24 If you'd you'll just mark them for me? 25 (Plaintiffs' Exhibits 4 through 6 00036 1 were marked for identification by the CSR.) 2 Q. BY MR. DOWNEY: All right, doctor, the 3 court reporter has placed before you three documents 4 that were produced by your counsel and sent to us. 5 They have three different versions of consent forms. 6 And, Don, I can't tell you exactly where in the pack 7 they came from. If you want to take a look at them to 8 make sure you're looking at the same thing. 9 A. These are all different. 10 Q. They're all different, right. 11 The reason I wanted you to take a look at 12 these doctor, they are obviously three different 13 versions of the consent form. Can you tell me which, 14 if any of those, represent the final consent form that 15 was used? 16 (Pause in the proceedings.) 17 THE WITNESS: This is even older than I thought. 18 Q. BY MR. DOWNEY: Why do you say that? 19 A. Because this is on Ward 256A. We then 20 moved up to Ward 256C and then up to the other 21 building. So more time -- so more time has elapsed 22 then I thought. That's probably why those other files 23 disappeared because 256A has been totally renovated and 24 is being used as medical clinics now, whereas 256C 25 there were a lot of old boxes there. That's where I 00037 1 found most of the stuff. 2 Q. Got you. 3 A. I would have to say 4 is the first one, 5 4 is the second one, and 6 is the last one. 5 Q. Okay. So the longest one, the five-pager 6 is the one that was probably -- 7 A. Each one has more disclosure in it. 8 Q. Right. Okay. 9 MR. RIDGE: Is that just your estimate, doctor, 10 or are you certain of that? 11 THE WITNESS: No, I'm not certain of it. But it 12 appears reasonable. There may be another one after 13 that that I don't know about. 14 Q. BY MR. DOWNEY: Doctor, on one of those 15 consent forms, Dr. Saunders' name was crossed off. Why 16 was that, do you know? 17 A. At the time that we were starting this, 18 Scott Saunders was working with me and he was going to 19 be a co-investigator. He shortly thereafter was 20 transferred off the ward and he never got involved with 21 any patients. 22 Q. Okay. So even though he initially signed 23 off on the protocol requests and on all of the 24 paperwork going to the institution review board -- 25 A. As a co-investigator. 00038 1 Q. -- he was not a co-investigator on this? 2 A. No. Never had anything to do with any 3 patient. 4 Q. Were there any co-investigators on this? 5 A. No. Dr. Glenn Schwartz replaced him and 6 didn't want to be involved with it. 7 Q. So it was just you were the only physician 8 that was involved in this? 9 A. That's correct. 10 Q. And you had some research assistants, 11 however, at the time -- 12 A. Priscilla Hood was my research assistant at 13 that time. And when they left a girl by the name of 14 April -- I can't remember April's last name. She went 15 on to become an anthropologist. 16 Q. Miss Hood did? 17 A. No. Priscilla Hood left. And April took 18 over and finished the study. And she went on to become 19 an anthropologist. 20 Q. What became of Priscilla Hood? Do you 21 know? 22 A. She's living in Santa Monica somewhere. I 23 haven't seen her in at least 10 years. 24 Q. You don't remember April's last name? 25 A. (No audible response.) 00039 1 Q. No? 2 A. I can ask some people on the ward and see 3 if they can remember. 4 Q. Were there any other research assistants 5 working with you or any other researchers working with 6 you on this protocol? 7 A. I don't think so. 8 Q. Very good. Next document I would like you 9 to authenticate for me, doctor, was produced pursuant 10 to the subpoena. This will be Plaintiffs' 7. It's a 11 letter on the letterhead of Lilly Research Laboratories 12 dated December 13, 1978. 13 Can you tell me what that is, doctor? 14 (Plaintiffs' Exhibit 7 was marked for 15 identification by the CSR.) 16 (Pause in the proceedings.) 17 THE WITNESS: It's a communication from 18 Dr. Slater in regards to a telephone conversation we 19 had, and changing his -- his thinking about changing 20 the protocol from the single blind to the double blind 21 and then enrolling the patients on to a known 22 anti-depressant. 23 Q. Okay. Do you recall the conversation of 24 that letter? 25 A. Not in the lease. 00040 1 Q. Okay. 2 A. But we never did it this way. 3 Q. All right. I noticed in the papers that 4 you produced there was an outline of protocol 14, which 5 was a double blind comparison with amitriptyline. Is 6 that the one he was talking about, do you remember? 7 A. That would be a study against another drug. 8 I don't think we -- I don't remember discussing that 9 one. 10 Q. Do you remember what drug he was going 11 to -- you were going to study it against? 12 A. I thought -- well, I don't -- we didn't 13 study it against something. We did it against a 14 placebo. 15 Q. Yes. Let me ask -- that was a badly asked 16 question. Do you remember what the comparator drug 17 that was being discussed as potential -- 18 A. I vaguely remember amitriptyline. But very 19 vaguely. 20 Q. Okay. That's fine. Doctor, this letter 21 states that enclosed with the letter was a copy of the 22 current fluoxetine hydrochloride brochure. And that 23 brochure was not attached to this letter when it was 24 given to us. Do you know what that refers to? 25 A. It may have been that -- the clinical 00041 1 profile that you had in the other -- it would not have 2 been a brochure like the brochures we're familiar with. 3 This drug was too new. There would have been nothing 4 like that published. So it would have been a stack of 5 papers like this with clinical information on it. 6 Q. So that that document that we marked that 7 was the narrative that included the pharmacological 8 information -- 9 A. It may have been that. Or something like 10 that. 11 Q. Doctor Slater indicates in this letter that 12 he hoped to be in California in January of 1979 and 13 requested or suggested a meeting. Do you recall 14 meeting Dr. Slater here sometime in the winter of '78, 15 '79? 16 A. No. 17 Q. Do you recall at any time having a 18 face-to-face meeting with any Lilly personnel prior to 19 the commencement of this research project? 20 A. Oh, absolutely. Charlie Schultz and Paul 21 Stark. And I know I met with Dr. Slater at least once 22 because I can remember what he looked like. 23 Q. Okay. So you met with all three of those 24 people? 25 A. Yeah. 00042 1 Q. Did you meet with them here or someplace 2 else? 3 A. Here in Los Angeles primarily. I went to 4 Indianapolis as a side trip from an APA meeting and I 5 met with Dr. Slater once there in the cafeteria and 6 just kind of took a tour of the manufacturing facility 7 as a courtesy of Dr. stark. 8 Q. And then the meetings that took place here, 9 what did those meetings consist of? 10 A. Discussing the protocol, how to implement 11 it. How many patients we could run. If I needed any 12 extra help from them in something. 13 Q. Okay. Was there anybody else at those 14 meetings besides yourself and, say, Dr. Slater or 15 Dr. Stark? 16 A. My research assistant would have been 17 present. 18 Q. That's Miss Hood? 19 A. It would be Miss Hood at the early part, 20 yeah. 21 Q. Anybody else there from Eli Lilly that you 22 can recall? 23 A. I don't -- I don't recall whether there was 24 always one individual or maybe several. But it was 25 only that group of people. Charlie Schultz turned out 00043 1 to be the clinical monitor for the study. So he was 2 around for quite awhile. And I think Dr. Slater went 3 on to do something else at Eli Lilly. 4 Can you correct me if I'm wrong on this? 5 MR. DOWNEY: It doesn't matter whether you're 6 right or wrong, doctor. We're just trying to get your 7 recall, and whether that turns out to have been correct 8 or mistaken doesn't really matter. 9 MR. ACHEN: Remember, it's not a test. 10 MR. DOWNEY: That's right. 11 THE WITNESS: And then Dr. Stark would come out 12 here frequently. 13 Q. BY MR. DOWNEY: Okay. And did you always 14 meet with him here in Los Angeles or did you also meet 15 with him down in Escondido? 16 A. Oh, no. This was long before they had 17 started that down in Escondido. Long before that. 18 Dr. Stark was working for Eli Lilly then. 19 Q. Okay. And did you at any time during this 20 test or during the -- let me rephrase that question. 21 At any time prior to the completion of the 22 fluoxetine protocol did you ever meet with or speak to 23 any other clinical trial researchers who were doing 24 fluoxetine work? 25 A. That's a tricky one. I may have. I may 00044 1 have spoken with some people at the -- American 2 Psychiatric Association meeting who were also running 3 the same trial. I'm thinking of one person who was 4 from Chicago. I can't remember his name. It was a 5 very general discussion. 6 Q. Okay. Did you ever meet with Dr. Kohn at 7 UCLA? 8 A. Jay Kohn? 9 Q. Yes. 10 A. Yeah. But I don't think it was during this 11 period of time. 12 Q. Okay. 13 A. He's not at U.C.L.A. He's down at U.C. 14 Irvine, isn't he? 15 Q. He may well be. He may well be. I may 16 have misspoken. I thought he was at U.C.L.A. when he 17 did the fluoxetine stuff. 18 A. But, yes, I did meet with him. 19 Q. Okay. Was this subsequent to your 20 completion of the fluoxetine trials? 21 A. I don't recall. He was an independent 22 investigator. He had a private company in Long Beach 23 and it may have been during that time. The only time I 24 really met with him, he invited me out on his boat. 25 And that was about it. I don't think we even discussed 00045 1 the protocol that much. 2 Q. It was primarily social? 3 A. Yeah. 4 Q. How about Dr. Finer. Did you meet with him 5 in regards to these protocols at all? 6 A. Not that protocol. Other protocols, yes, I 7 have met with John. 8 Q. And what did those meetings consist of? 9 MR. RIDGE: Protocols concerning fluoxetine? 10 THE WITNESS: No, no. 11 Q. BY MR. DOWNEY: Okay. This is just -- did 12 Dr. Finer's company get involved in administrating some 13 of the protocols of other drugs that you investigated? 14 A. Later. Subsequently. 15 Q. Okay. That was the international clinical 16 research -- 17 A. That's correct. 18 Q. -- was involved in those? Nothing that 19 involved fluoxetine? 20 A. No. I think it was during this period of 21 time that Dr. Stark left Eli Lilly and went with 22 Dr. Finer. 23 Q. Okay. 24 A. So I would have met -- at that point in 25 time I would have met Dr. Finer one time. 00046 1 Q. And what was that one time? 2 A. Dr. Stark was interested in starting ICRC. 3 And he wanted me to go in with him. And I didn't want 4 to take the risk, unfortunately. It was a very bad 5 move on my part. And he took me down to meet John 6 Finer and we talked about forming the company, but that 7 was my only -- 8 Q. Was that while you were still doing the 9 fluoxetine protocol up here? 10 A. I think it might have been because that was 11 before John -- that was before Paul had left. And Paul 12 had left during the fluoxetine study. 13 Q. I'm sure we'll jog -- these things do tend 14 to jog your memory. 15 Next exhibit, Exhibit 8 is a letter dated 16 February 21, 1979, and it's I believe six pages. It 17 includes the charts. If you'd take a look at that. 18 (Plaintiffs' Exhibit 8 was marked for 19 identification by the CSR.) 20 THE WITNESS: These would be the results of 21 preliminary trials that he had. 22 Q. BY MR. DOWNEY: Do you recall reviewing 23 that letter and those results? 24 A. No. 25 Q. Now, this was February 21, 1979, is the 00047 1 date of that. And I gather from the tone of the letter 2 that at this point you had not commenced the actual 3 studies; is that correct? 4 A. No. No. 5 Q. No, meaning -- 6 A. No, we had not commenced the study. 7 Q. Thank you. All right. 8 Next document, Exhibit 9, is a single page 9 dated April 2, 1979, signed by Dr. Slater. Actually 10 it's signed -- it's an interesting document. It looks 11 like it was a memo from the protocol review committee 12 at Lilly that was then typed on and signed by 13 Dr. Slater. Take a look at that, doctor. 14 (Pause in the proceedings.) 15 (Plaintiffs' Exhibit 9 was marked for 16 identification by the CSR.) 17 THE WITNESS: Okay. 18 Q. BY MR. DOWNEY: Do you recall receiving 19 that letter, doctor? 20 A. No. 21 Q. Do you know what it refers to? 22 A. Yes. 23 Q. What is that? 24 A. That lithium would be an exclusion. If the 25 patient were on lithium he wouldn't be admitted to the 00048 1 study. 2 Q. Okay. Now, it mentioned an Eldon Van 3 Meter, the medical information assistant. Do you 4 recall that person? 5 A. That name doesn't ring a bell at all. 6 Q. It also mentions Dr. Slater was talking 7 about meeting you once everything is approved to go 8 over the forms and shipments and all of -- 9 A. Obviously he didn't make it in January. 10 Q. Obviously. Do you remember having a 11 meeting with Dr. Slater prior to kick off of the 12 research? 13 A. No. I think it was with Dr. Stark. 14 Q. Okay. By that time Dr. Slater had left and 15 Dr. Stark had replaced him? 16 A. (Nodding.) 17 Q. Yes? 18 A. Yes. 19 Q. Thank you. I just want to make sure we get 20 it out loud. 21 Next exhibit, Exhibit 10 is a letter with 22 your typed name on it dated June 1, 1979. Attached to 23 it is a four-page research proposal entitled 24 Biochemical Correlates of the Therapeutic Efficacy of 25 Fluoxetine in the Treatment of Major Depressive 00049 1 Disorders. It's got two appended pages, one is a 2 budget and one is a list of references. 3 Would you take a look at that for me, 4 doctor. 5 (Plaintiffs' Exhibit 10 was marked 6 for identification by the CSR.) 7 (Pause in the proceedings.) 8 THE WITNESS: I believe this was a proposal for a 9 side project that I had proposed to measure the plasma 10 levels of fluoxetine during the study. And if my 11 memory serves me correctly, they decided not to do 12 that. 13 Q. BY MR. DOWNEY: Okay. So this is not the 14 original grant proposal for the protocol -- 15 A. Oh, no, no. This is just to measure plasma 16 concentration of the drug. This was to be done in a 17 different lab. We would take the plasma samples and 18 then send them to this lab. I'm pretty sure I know 19 what those ink outs are. 20 Q. That's fine. The plasma samples in the 21 protocol weren't analyzed by you, they were sent 22 directly to Eli Lilly; is that correct? 23 A. Correct. 24 Q. Has a very small budget on this one. It's 25 only about $6,000; yes? 00050 1 A. Yes. 2 Q. Do you remember what the budget was for the 3 protocol? 4 A. I -- it would be easier to tell you what it 5 would be now. I'm going to guess and cut it in half 6 and say probably about $35,000. 7 Q. And lawyers in a deposition hate the word 8 guess. We prefer the word estimate if you have -- 9 A. Oh, estimate. Okay. 10 Q. What you're saying is that a project this 11 size in the market of today would have a budget of 12 approximately $70,000? 13 A. $70,000. That's correct. 14 Q. And you estimate that back in 1980 the 15 budget may have been half of that? 16 A. Was half. Well, this required several 17 ophthalmological exams. And each ophthalmological exam 18 cost us $75. The cost of the EKG, the lab work, the 19 research assistant to do -- take all the stuff down. 20 I'm just trying to figure in 1980 dollars. 21 Q. I see. Now, that is for the outside 22 vendors to the project. The ophthalmologist, the EKG 23 guy? 24 A. That's correct. 25 Q. Did money go directly to you or to the VA 00051 1 from Lilly to do this project? 2 A. No. The money went to a research 3 foundation. Then the research foundation would take 4 care of whatever expenses were necessary. 5 Q. Okay. And the types of expenses would be, 6 obviously, the outside physicians who would do these 7 analyses. What other expenses would be involved in 8 a -- 9 A. The salary of the research assistant. The 10 shipping of blood samples. The drawing of blood 11 samples. Equipment that was necessary for the study, 12 probably a computer, telephone service, paging service. 13 It might have been a trip to a meeting. 14 Q. And was there any -- but there was no other 15 direct remuneration to you -- 16 A. That's prohibited. 17 Q. Okay. So the only -- so you don't get any 18 direct remuneration from Lilly via the research 19 foundation for doing a project like this? 20 A. No. 21 Q. It's only you get to publish a paper? 22 A. You get to publish a paper. There are 23 certain perks. You know, if you're office is too hot 24 you can buy an air conditioner with the money. You can 25 buy furniture. But you can't put it in your pocket. 00052 1 Q. I understand. Okay. I was -- that's what 2 I was trying to get a handle on is just what it means. 3 I know the private research guys can put it right in 4 their pockets? 5 A. Put it right in their pockets, right. 6 Q. I was just trying to figure out what 7 benefit to a guy like yourself who's working for the 8 VA. Okay. 9 All right. Next exhibit, Exhibit 11 will 10 be a letter dated January 30, 1990, on VA letterhead 11 from Priscilla Hood to Dr. Stark. I'll have you take a 12 look at that. 13 (Plaintiffs' Exhibit 11 was marked 14 for identification by the CSR.) 15 (Pause in the proceedings.) 16 THE WITNESS: Okay. So the study is going 17 January 30, 1980. And apparently had been going in 18 August of '79. 19 Q. BY MR. DOWNEY: Okay. So you know that it 20 was at least in -- well, actually there's a note in 21 here by -- that says by comparing the EKG's done on 22 7/24, 8/28, 12/7 and 12/29/1979, EKG is stable. Can 23 you determine by that that at least -- 24 A. The study had started, yes. 25 Q. At least in July of 1979 it had started? 00053 1 A. The only date I saw was August. 2 Q. 7/24. 3 A. Okay. Then the study must have started 4 7/24. Or before. 5 Q. Or before. Very good. And by January 30, 6 1980, Ms. Hood talks about one patient who has 7 completed the study. So at least one patient had 8 completed by that time; correct? 9 A. Correct. 10 Q. A question for my edification. Tonometric. 11 T-o-n-o-m-e-t-r-i-c. What does that mean? 12 A. That measures the intraocular pressure in 13 the eye. One of the important parts of the study was 14 that this drug does not increase intraocular pressure. 15 And it became very important to measure that and 16 confirm what we already knew because almost all of the 17 other anti-depressants are contraindicated in people 18 with glaucoma. This is a very safe drug to use in 19 people with glaucoma. 20 Q. There's a name in this first paragraph. 21 Farid. F-a-r-i-d. Do you have any idea who that was? 22 A. I think he was the cardiologist. 23 Q. That's the cardiologist -- 24 A. That read the EKG's for the study. 25 Q. And that's somebody that you had contracted 00054 1 with? 2 A. That's correct. 3 Q. And this indicates that at least one of the 4 patients had some abnormal EKG findings at one point? 5 A. Yeah. Yeah. These were EKG changes that 6 occurred during the study. The study was stopped on 7 this patient, and I think that it was questionable as 8 to whether it was drug related or not. But the study 9 was stopped, anyway. 10 Q. Do you know if a form 1639 was ever filed 11 regarding that patient? 12 A. No, I don't know. And I don't think -- I 13 don't think it was. 14 Q. Why would it not have been to your 15 recollection? 16 A. I don't think at that time that we thought 17 that the -- that the problem was drug related. 18 Q. Okay. 19 A. Because he continued to demonstrate 20 abnormalities after the drug was stopped that were 21 totally different than what had occurred when he was on 22 the drug. 23 Q. Okay. Other than this one patient, were 24 there any other patients that exhibited abnormal EKG's 25 while they were on this drug? 00055 1 A. I certainly can't remember that. 2 Q. Do you think you would have remembered if 3 there had been or is it -- 4 A. I can say that I don't think that there 5 were any serious ones. I would have remembered that. 6 Q. Did you personally ever complete any form 7 1639's or file any form 1639's during this fluoxetine 8 trial? 9 A. I don't believe so. 10 Q. Was that because there were no -- 11 A. There were no unusual adverse reactions. 12 Q. Exhibit 12 is nine pages that came to us 13 stapled together. They all appear to contain 14 photocopies of a small tag labeled Fluoxetine Blood 15 Level Transmittal. And they seem to be for several 16 different patients. Doctor, can you take a quick look 17 at that for me; let me know what it is. 18 (Plaintiffs' Exhibit 12 was marked 19 for identification by the CSR.) 20 THE WITNESS: These are the records of the blood 21 samples that were sent to Eli Lilly for analysis. Some 22 of these, or the majority of these were routine. And 23 one of them was because the patient is not responding. 24 Q. BY MR. DOWNEY: That's the tag for patient 25 4? 00056 1 A. Patient 4. Correct. 2 Q. Great. And what was the date on that? 3 A. 7/31/80. 4 Q. At that time when that was sent, had 5 patient 4 been terminated from the study? 6 A. I don't know. 7 Q. And it's coded 2. And what does 2 mean? 8 A. Non-responsive. 9 Q. And non-responsive means? 10 A. The patient has not increased to the point 11 where you think that the patient is going to get well. 12 You would expect by this time we're talking about 21 13 days you expect to see a response by then. 14 Q. So the patient had been on the drug for at 15 least 21 days by that point? 16 A. Um-hmm. 17 Q. Yes? 18 A. Yes. 19 Q. And you can tell that because of the dates 20 on the blood tag? 21 A. On the blood tag, yeah. 22 Q. Do you remember that patient? 23 A. No. 24 Q. Always worth a try. 25 Doctor next exhibit is Exhibit 13. It's a 00057 1 letter, looks like a marked-up letter under VA 2 letterhead dated April 21, 1980. Exhibit 13. Can you 3 take a look at that? 4 (Pause in the proceedings.) 5 (Plaintiffs' Exhibit 13 was marked 6 for identification by the CSR.) 7 THE WITNESS: Okay. This is a communication from 8 my research assistant to Gisele Soyez, concerning 9 report forms she had sent back that she felt were 10 incomplete or not filled out properly. And after 11 Priscilla had typed this, I had put some changes on 12 here and then she would have retyped it and sent it. 13 Q. BY MR. DOWNEY: Okay. Is that your 14 handwriting, those changes? 15 A. I think it's Priscilla's handwriting. 16 Q. All of it? 17 A. I really can't tell. I mean, I -- I'm not 18 sure it's her handwriting. I don't think it's my -- 19 I'm sure it's not my handwriting. 20 Q. Is anything on that in your handwriting? 21 A. No. 22 Q. Okay. Who would have done these changes? 23 Would you have dictated these changes to her? 24 A. I would have told her what to change, yes. 25 Q. Okay. Now, some of this is very unclear on 00058 1 this copy, and I don't know if you can do any better 2 than I can. But in the bottom half of the letter there 3 is a listing of patients, the patient numbers have been 4 redacted pursuant to 552 B -- 5 MR. ACHEN: 5 USC 552 B6. 6 Q. BY MR. DOWNEY: And I wonder if you can 7 help me out at all interpreting what these changes are, 8 starting in that lower half of the report here. Is 9 there any way you can read me what those things say? 10 Some of it's pretty unclear. 11 (Pause in the proceedings.) 12 THE WITNESS: No. 13 Q. BY MR. DOWNEY: Let me see just to make 14 sure. Now, under the heading "Status" six lines down, 15 the original letter said "second #04, received 2 days 16 of placebo, became manic." 17 A. Manic, right. 18 Q. And that is the received to manic is 19 crossed out; correct? 20 A. Correct. 21 Q. All right. Then written up above it, it 22 appears to be dropped. Is that -- 23 A. I would have to assume the patient was 24 dropped because you have the number 4 done three times. 25 So in other words this patient was dropped. Used 00059 1 number 4, this patient was dropped. Used number 4, 2 again this patient was dropped. The reason they're 3 dropped is because none of them were far enough in the 4 study to be considered as a participant. They were 5 still on placebo. 6 Q. Do any of these three patient number 04's 7 correspond to the patient number 04 who was terminated 8 because of lack of efficacy in July as noted on this 9 fluoxetine blood level transmittal tag? 10 A. I have absolutely no idea. This 04 was 11 dropped. It was probably another 04. 12 Q. Okay. And -- 13 A. And this patient was in the study long 14 enough that he would not have been dropped. That would 15 have been a valid number. 16 Q. All right. Well, this notation is that 17 they're receiving this blood level transmittal July 31, 18 1980, and the reason for the assay is failure of study 19 drug therapy. 20 A. That's the second transmittal. 21 Q. That's correct. 22 A. But he would not have dropped that patient. 23 He would be a -- counted as a patient. 24 Q. Because he had been there at least since -- 25 July 9? 00060 1 A. Well, he had been receiving active drug. 2 Q. Since at least July 9? 3 A. Once a patient receives any active drug, 4 they are now a number. 5 Q. And you didn't terminate him for lack of 6 efficacy? He probably completed the study? 7 A. Unless it was the same one that had that 8 EKG problem. I don't remember what the number was on 9 that. 10 Q. Let's check here. It doesn't say on here. 11 No. This is number 4 abnormal EKG 8/28/79. 12 A. That is the patient number. 13 Q. The patient number is redacted. 14 A. And the dates are wrong. So it wouldn't be 15 number 4. 16 Q. The dates are wrong. So it was one of 17 these patient number 4's. Was it this first one who 18 didn't receive any medication? Because if he had 19 received no medication there would be no blood 20 transmittal. 21 A. Right. 22 Q. It wasn't the second number 4 who received 23 two days of placebo and then became manic? 24 A. Well, it may be that the patient did not 25 actually receive the placebo if it is crossed out. 00061 1 Q. I see. And then for whatever reason that 2 patient was terminated before he was actually enrolled, 3 and a third number 4 was enrolled? 4 A. Right. Was enrolled but not -- 5 Q. Again he received no medication and left 6 the hospital? 7 A. So the number was used again. 8 Q. So the number 4 then probably the next one 9 down was completed. 10 A. May have been this patient. 11 Q. This patient here. 12 Exhibit 14 is a copy of a mailing label. 13 (Plaintiffs' Exhibit 14 was marked 14 for identification by the CSR.) 15 Q. BY MR. DOWNEY: Very quickly, doctor, 16 there's a phone number that has been blanked out. Do 17 you have any reason to -- do you know why that phone 18 number was blanked out? 19 A. It's probably Dr. Stark's personal phone 20 number. 21 Q. Okay. That's best estimate on that? 22 A. To the best of my knowledge that would be 23 the reason. 24 MR. DOWNEY: Is there any other reason why an Eli 25 Lilly Company, Mr. Achen, why an Eli Lilly phone number 00062 1 would be redacted? 2 THE WITNESS: This was probably a personal phone 3 number because in case of emergency. 4 Q. BY MR. DOWNEY: Do you know what MIA stands 5 for? 6 A. Medical investigator assistant. Something 7 like that. He was the person that I would contact if 8 there was a problem. 9 Q. So you think this is somebody's home 10 number? 11 A. Either a home number or an emergency 12 number. 13 A. There were numbers that they gave us to 14 call and we can call 24 hours a day 7 days a week and 15 they would know how to get ahold of the people we 16 needed to talk to. 17 Q. Got you. 18 A. Fortunately we never had to have that used. 19 Q. Never had to do that on this study? 20 A. Pardon me? 21 Q. Never had to do that on this study? 22 A. No. 23 Q. Good. Next, Exhibit 15 is a letter from 24 Paul Stark to Dr. Gosenfeld March 27, 1981. It's 25 talking about some -- this is well after the 00063 1 termination of this study, isn't it, doctor, at this 2 point? 3 (Plaintiffs' Exhibit 15 was marked 4 for identification by the CSR.) 5 THE WITNESS: I don't know. 6 Q. BY MR. DOWNEY: Okay. The real reason I 7 want you to look at that letter is the P.S. on there: 8 "I am also enclosing a curriculum vitae for you." 9 Why was Paul Stark sending you his c.v. in 10 March of 1981? Was that when he was tried to convince 11 you to join him and John Finer? 12 A. That may well have been. That may well 13 have been. 14 Q. Can you think of any other reason why he 15 would be sending you his c.v.? 16 A. At that time I had an appointment to the 17 pharmacy department at U.S.C. as an instructor. I 18 don't think he was looking for a job there, though. I 19 mean, he had a much better job at Eli Lilly. That paid 20 a great deal more. So that -- that doesn't make any 21 sense. 22 Q. Paul's not a doctor, not an M.D.? 23 A. He's a Ph.D. in pharmacology. 24 Q. Right. 25 A. I think he was a professor at University of 00064 1 Indianapolis or University of Indiana. 2 Q. Doctor, after you completed the fluoxetine 3 studies, did you ever publish your results in any 4 manner? 5 A. No. 6 Q. Did you ever develop a paper that was 7 submitted for publication? 8 A. No. Our study was not big enough to do 9 that for. Our data was pooled with other studies. 10 Q. The data was pooled with other studies and 11 a paper was written -- 12 A. Papers were written by people on the east 13 coast. 14 Q. Who was that? Do you remember? 15 A. No. I think maybe Don Rickles was one of 16 them. There was a -- no. I just can't remember the 17 name. There were papers published, obviously, though. 18 Q. There have been a number of papers 19 published regarding fluoxetine, yes. 20 A. Yes. 21 Q. To your recollection, though, the data from 22 your study was only published in a paper published by 23 somebody in the east coast, possibly Dr. Rickles? 24 A. They would have combined the data. In 25 other words, I think we, as I said, we ran 22 patients. 00065 1 That's not enough to be of much significance. So there 2 were probably five other studies that data was all 3 pooled and then the senior investigator published the 4 study. Probably whoever had the most number of 5 patients. 6 Q. Got you. Do you recall ever seeing a paper 7 that published the results of fluoxetine compared with 8 placebo only? 9 A. Oh, yes. Yes. Definitely. I don't 10 remember who the author was, though. 11 Q. Do you remember which of the journals it 12 appeared in? 13 A. No. 14 Q. Do you remember when it came out, 15 approximately? 16 A. I would think maybe 1985. 1984. 17 Q. Prior to -- 18 A. Prior to the drug going on the market. 19 Q. And you didn't write up anything for that 20 paper? 21 A. No. 22 Q. After the completion of the study was there 23 any type of a report that you were required to write 24 for Eli Lilly? 25 A. Not that I recall. I was required to write 00066 1 a report for the hospital. 2 Q. And did you write a report for the 3 hospital? 4 A. Right. 5 Q. That report was not included in the papers 6 that we requested from you. 7 A. It -- it would be -- would have been in 8 research service. And if it's not in -- if it's not in 9 the -- I went to research service and retrieved 10 everything from the file. So if it's not there, 11 it's -- the report essentially says we finished X 12 number of patients, the study is concluded. There were 13 no patients that died or had adverse effects. And 14 that's it. 15 Q. And you didn't keep copies of those kinds 16 of papers in a personal file? 17 A. Normally I would have, sure. It's just 18 been too long. 19 Q. Doctor, as you sit here can you recall 20 observing any side effects to the drug in the 21 individuals that you tested back then? 22 A. I recall that some people complained a 23 little bit about nausea. Essentially it was a very 24 benign drug. 25 Q. Did you ever have any of the patients 00067 1 complain of agitation? 2 A. No. No. That surprised me when I heard 3 about that. 4 Q. Any of the patients complain about 5 insomnia? 6 A. They may have. They may have because the 7 drug was given at bed time and it should not have been. 8 Q. Do you recall as you sit here whether any 9 of the patients required chloral hydrate to sleep? 10 A. I'm fairly certain they did. 11 Q. When you say it shouldn't have been given 12 at bed time, what do you mean? 13 A. The drug is stimulating. It's now -- when 14 you prescribe it now days, you prescribe it in the 15 morning. And if you have to give a second dose, you 16 give it in the afternoon. But you don't give it at bed 17 time. 18 Q. What do you mean by the drug is 19 stimulating? 20 A. It makes people feel more activated. They 21 don't feel as tired as opposed to Trazodone, where you 22 give that at bed time because it sedates people. 23 Q. Is there a particular constellation of side 24 effects that would be expected from a stimulating drug? 25 A. Well, you know, the stimulation that I've 00068 1 seen with Prozac is a very mild kind of energizing. 2 Now, other people have reported a huge amount of 3 stimulation. And I think that's because it's given to 4 the wrong people. 5 Q. What do you mean by that? 6 A. That they're not depressed. That they're 7 people who are either paranoid, where anti-depressants 8 are contraindicated. Or to borderline personality 9 disorders who wind up taking more drug than they 10 should. And then they will become -- they're not 11 stimulated, they're wired. 12 Q. But you've never experienced that on 13 depressed patients that have been given the drug? 14 A. No. I'm pretty good at diagnosing 15 depression as opposed to other illness. I don't use 16 anti-depressants indiscriminately. 17 Q. A lot of people do. 18 A. A lot of people do. I understand that. 19 Q. Is it your opinion as a psychiatrist that 20 this drug should not be used in patients who are not 21 clearly diagnosed as depressive? I gather that's what 22 you're saying from what you just said. 23 MR. ACHEN: Well, may I interject? Are you 24 asking him as an expert witness or a percipient 25 witness? 00069 1 Q. BY MR. DOWNEY: We just sort of started 2 talking about that, and I wanted to make sure that I 3 understood what he was saying. I'm not asking for his 4 expert opinion. 5 MR. ACHEN: Well, just for the record you do not 6 have to answer if you feel you're getting into the 7 realm of an expert witness. We had talked about that. 8 So that's up to you whether you even want to offer an 9 opinion. 10 THE WITNESS: I have no problem with that. You 11 want to rephrase your question? 12 Q. BY MR. DOWNEY: Sure. Basically what I was 13 saying is that I gather from what you said, you said 14 that your conclusions seem to be that the people who 15 seem to get in trouble prescribing the drug is because 16 they're really not prescribing it for depressed 17 patients; they're prescribing it to people with other 18 disorders. 19 A. With other disorders, correct. 20 Q. And I guess what you're saying is that that 21 is -- well, I don't want to get into asking your 22 opinion. I don't -- I haven't hired you as an expert 23 witness. I'm just sort of picking your brains. 24 A. I was trying so hard. 25 Q. You're doing real good. I was just sort of 00070 1 picking your brains. Would you say then that if you 2 prescribed this to somebody who is not depressed is 3 when you're likely then to see these kind of side 4 effects? 5 A. No. You're likely to see it when you 6 prescribe it to somebody who has another diagnosis and 7 you don't prepare for it. It can be used in paranoid 8 schizophrenia. But you would not use this alone. You 9 would have to use a neuroleptic with it. Otherwise you 10 would wind up with somebody who is much worse. I mean, 11 that's not my opinion, that's in the text books. 12 Q. Right. Have you ever had to use either a 13 neuroleptic or a benzodiazepine concomitant with 14 Prozac? 15 A. No. I usually don't do that. I have used 16 a neuroleptic in somebody who was psychotically 17 depressed just to get them over the psychotic point and 18 then just withdrawn the neuroleptic. 19 Q. Okay. Do you know Dr. Wershing? 20 A. Sure. 21 Q. He works here? 22 A. He's here. 23 Q. Are you familiar with the research that 24 he's done? 25 A. Most of it, yeah. 00071 1 Q. In terms of Prozac -- 2 A. Negative and positive symptoms -- well, no. 3 Q. He's done -- he's done some papers 4 regarding Prozac in akathisia. Are you familiar with 5 those papers? 6 A. Um-hmm. 7 Q. Yes? 8 A. Yes. 9 Q. All right. Did you ever observe any of 10 that in the people that you tested? 11 A. No. No. 12 Q. Have you observed that in people that 13 you've subsequently treated with Prozac? 14 A. No. No. 15 Q. Do you have -- and this again, if I'm 16 asking for an expert opinion and you don't want to 17 answer me, that's fine. Just curious. Do you -- why 18 do you think he found that akathisia. Do you think 19 it's because people weren't really depressed? 20 A. No. I think he was looking at a different 21 population. 22 Q. By which you mean? 23 A. That they weren't strictly bi -- unipolar 24 depressives. 25 Q. You think they had other affective 00072 1 disorders? 2 A. Other affective disorders or they may have 3 been schizophrenic and he was using it for the 4 depressive symptoms of schizophrenia. 5 Q. The depressive symptoms of schizophrenia? 6 A. Right. In which case your not likely to 7 see akathisia. 8 Q. Are you familiar with the papers that claim 9 that Prozac can at times induce violence or suicide? 10 MR. RIDGE: I want to object that lacks 11 foundation until we identify those particular papers 12 and get them before the doctor because I have no idea 13 what you're talking about. 14 Q. BY MR. DOWNEY: Fine. Let me rephrase it 15 slightly. 16 Are you familiar with any scientific papers 17 or articles that have claimed that Prozac can induce 18 violence or suicide? 19 A. No. I'm familiar with the claims. But 20 I've not seen well written research papers that prove 21 that. 22 Q. Just, again, identifying some of the 23 documents that were produced to us. 24 Next 16 is a seven-page document. At the 25 bottom of the first page is a typewritten date 6/16/80. 00073 1 The top right hand corner of the first page is a 2 handwritten date, 9/15/80, and it's an outline, it 3 looks like, of IND protocol number 25. That was in 4 your papers, doctor. Do you remember seeing that? 5 A. I think this was a proposal for an 6 outpatient study of Prozac and we did not get involved 7 with it. 8 Q. Do you think that it was -- there was some 9 discussion of your getting involved with it? 10 A. Oh, yes. Absolutely. 11 Q. That's why you were sent that. I see. 12 There's a little handwritten stuff on the 13 front page on the bottom. Do you have any idea what 14 that is? 15 A. No. 16 (Plaintiffs' Exhibit 16 was marked 17 for identification by the CSR.) 18 Q. BY MR. DOWNEY: Okay. Exhibit 17 appears 19 to be an invoice on Eli Lilly & Company letterhead 20 dated 8/22/79. This is in among the papers that you 21 produced, doctor. Can you tell me what that is? 22 A. This was probably the first -- the first 23 installment on the protocol. It was payable to Friends 24 from Eli Lilly. 25 Q. I just -- you answered my question even 00074 1 before I asked it. This is only for $6,000. What the 2 heck could it be? And this you think is just an 3 installment? 4 A. Yeah. 5 (Plaintiffs' Exhibit 17 was marked 6 for identification by the CSR.) 7 Q. BY MR. DOWNEY: Okay. Next exhibit number 8 18 is a -- it looks like an invoice. It's two pages. 9 It looks like an invoice and possibly a real lousy 10 photocopy of an airline ticket dated November 5, 1979. 11 Can you identify that for me, doctor? 12 A. In was a -- this is the way we bill 13 Friends. I don't know who it was for since it's inked 14 out. And my signature authorizing payment of it. And 15 as you said, an airline ticket. 16 Q. Okay. So would this illustrate then, and 17 that is what I was showing this to you, for. This 18 illustrates the type of reimbursement that you would 19 get, be eligible for under the grant would be 20 reimbursement. For example, transportation -- 21 A. To a meeting. 22 Q. -- to a conference that had some relation 23 to the study that was going on? 24 A. What you were doing, exactly. 25 Q. Okay. And this is to some, I notice that 00075 1 there were a couple of Ph.D.'s who were assigned to the 2 project with you or somehow were on the project -- 3 A. John Houlihan, who is a psychologist on the 4 ward. It may have been for him to attend a conference. 5 But I don't know for sure. 6 Q. Most of these bills refer to as you said 7 things like ophthalmologic examinations and that sort 8 of stuff, and those would be billed directly to 9 Friends? 10 A. Well, the ophthalmologist would send me a 11 bill for X number of exams, and I would have Priscilla 12 prepare one of these. I would sign it. It would get 13 sent to Friends and they would send him a check. 14 Q. Got you. Now, down at the of these there 15 is a project number, 18020-1-74. Was that your 16 internal number or was that Friends -- 17 A. That was Friends' number. 18 (Plaintiffs' Exhibit 18 was marked 19 for identification by the CSR.) 20 Q. BY MR. DOWNEY: Okay. Here again this is 21 another one. We'll just take a look at these for some 22 examples of this stuff. 23 Number 19 is an invoice January 4, 1980, 24 which is an advance for half of a registration fee. 25 And this is to send one of the psychologists who were 00076 1 working with you -- 2 A. It may have been a social worker. American 3 Institute of Group Psychotherapy. It could be either. 4 Q. You also had a social worker that was 5 working with you on this? 6 A. Well, these people were not working on the 7 project per say. But you have to remember that these 8 patients are also hospitalized and require other 9 hospital services. And so where the social worker was 10 not listed on the protocol because he did not work 11 strictly with the protocol. But he worked with those 12 patients as well as all the other patients. 13 Q. Okay. And that was because he was working 14 with those patients or she was working with those 15 patients and something at that conference pertained to 16 what those patients -- 17 A. Well, it pertained to depression. But it 18 was also other perk for the extra work that they were 19 doing. 20 Q. I got you. They weren't getting paid -- 21 A. They weren't getting paid for it. 22 Q. -- to do the work of helping you fill out 23 the forms and stuff like that? 24 A. It was more than that. When you do 25 research, what you do is more methodical. You have to 00077 1 document more. You have to keep better records. And 2 so they had to go the extra mile. And so this was to 3 compensate them for it. 4 (Plaintiffs' Exhibit 19 was marked 5 for identification by the CSR.) 6 Q. Got you. Now, there were the clinical 7 report forms that you were filling out and that 8 apparently were destroyed years ago. Were copies of 9 the patient's medical records included with that stuff 10 or were those kept by somebody in a totally different 11 area? 12 A. No. The medical records are kept by 13 medical records. At that time we did not keep 14 duplicate records. In current studies, we xerox the 15 progress notes. We xerox the lab work. And we keep it 16 in a separate file in case we have an FDA audit. And I 17 just did have an FDA audit and, you know, we passed it 18 quite nicely because we had all this information. But 19 this is 10 years before. 20 Q. And procedures were different then? 21 A. Procedures were different then. Correct. 22 Q. Do you know Dr. Louis Faber? 23 A. Yes, I do. 24 Q. Did you work with him at all in this? 25 A. No. 00078 1 Q. Did you work with him on the Halcion? 2 A. No. I know he worked with Mr. -- with 3 Dr. Stark, but I've only met Lou a couple times at 4 meetings. And I don't know him very well. 5 Q. Okay. For example, October 2, 1980, you 6 sent in a request for payment to Friends for some work 7 that was done regarding programming service on your 8 computer, and this would qualify as one of the perks 9 that were? Yes? 10 A. Well, this was -- this was -- I don't know 11 if that would be a perk. This may have been directly 12 related to the study. 13 Q. Got you. Did you do some of the number 14 crunching for the study using your computer? 15 A. Yes. 16 Q. Do you know where the computer -- do you 17 still have that data anywhere on floppies? 18 A. No. No. No. No. No. I'm positive of 19 that. 20 Q. Do you still have a computer? 21 A. I even have the computer. 22 Q. Doctor, one of the items that you were 23 reimbursed for during this project was for video 24 cassettes. Did you do any videotaping of -- as part of 25 this? 00079 1 A. No. What we did was videotaping of a 2 clinical interview. This was using staff members to 3 demonstrate how you interview a patient for a study. 4 So you have some consistency in whose doing the 5 interviewing, that you ask the same questions in the 6 same way. 7 Q. Do you still have that videotape? 8 A. No. Don't have the recorder, either. 9 Q. Did you provide a copy of that videotape to 10 Eli Lilly? 11 A. No. 12 Q. Something you used for internal training? 13 A. For our internal purposes. 14 MR. DOWNEY: Why don't we take five. I may well 15 be done. I just want to look over my notes. 16 (Recess taken.) 17 Q. BY MR. DOWNEY: Doctor, during the time 18 that you were conducting this trial, did any 19 representatives from Eli Lilly visit the facility to 20 review your clinical report forms? 21 A. Yes. 22 Q. How often did that occur? 23 A. At that time I don't think they came 24 monthly. I would say more like six weeks to two 25 months. Nowadays it's monthly. 00080 1 Q. And that goes not just for Lilly but for 2 all of the -- 3 A. For all of the companies, yes. 4 Q. And when they came, do you remember who the 5 person was who was coming from Lilly at that point? 6 A. I want to say Charlie Schultz, but I'm not 7 sure. 8 Q. How long would they spend? 9 A. They would go over the -- all the case 10 booklets and look through them. 11 Q. By case booklets, you mean the case report 12 forms? 13 A. Well, yeah. The case report forms were in 14 book form. And they were, like, three or four copies. 15 And one copy went to Eli Lilly, one copy went to 16 myself. I guess one copy went to the FDA for 17 submission. 18 Q. Theoretically, yes. 19 MR. RIDGE: Objection. Move to strike. 20 Q. BY MR. DOWNEY: You brought something up. 21 This is new to me. We've only seen single sheets. I 22 didn't realize these things were in a booklet even. Do 23 you mean it was just the bound booklet? 24 A. It was a booklet about yea thick -- 25 Q. By yea, you're indicating about three, four 00081 1 inches? 2 A. About four inches thick. And it was in -- 3 it was either spiral bound or punched, one of the two. 4 And each case report form was in four parts. So when 5 you finished filling out the report form, after it was 6 checked, then you broke it apart and sent it, I believe 7 all the copies except one got sent to Eli Lilly. We 8 did not send copies directly to the FDA. Lilly would 9 have sent that as one whole stack. 10 Q. So you would start out with this one of 11 these booklets and were there -- was there some sort of 12 control number to ensure that you knew that all of 13 these report forms would go to one patient? 14 A. Well, the books were numbered. And then 15 the pages were numbered. And each group of pages would 16 represent a clinical visit. There would be one page, 17 group of information for vital sign. There would be 18 one group of information for the clinical depressions 19 scale. There would be one group of information for the 20 Hamilton depression scale. And this was your -- in 21 other words, and there was a divider between them. So 22 this was visit number 7. These were the things you did 23 on visit number 7. And then you'd know that maybe 24 visit number 8 you'd need another physical exam. So 25 there would be a different form in there. And visit 00082 1 number 12 there might be an ophthalmological exam, and 2 so you'd have the ophthalmological form in there. 3 Q. And these booklets all had some sort of a 4 control number in the upper left hand corner or 5 something? 6 A. I don't think so. I think you would sign 7 the number or it may have been -- no. Because we 8 would -- we used number 4 three times. So I think we 9 would assign the number. 10 Q. So you would -- so in other words when the 11 second number 4 or the third number 4 started, you 12 would start a whole new booklet -- 13 A. Yes. Exactly. 14 Q. You wouldn't reuse any part of the original 15 booklet? 16 A. Yes. 17 Q. What did you do with those original 18 booklets? Did you send them back to Lilly -- the ones 19 that say were started had but not finished? 20 A. No. Those were probably thrown away. 21 Q. At any time did you attend a meeting -- I 22 think you've already answered this, but I just want to 23 verify -- with Lilly representatives and other clinical 24 trial investigators, any sort of a clinical -- any sort 25 of a kick off meeting or anything like that on this 00083 1 particular drug? 2 A. I don't recall it, but there probably would 3 have been. 4 Q. That's typical? 5 A. Well, it's typical nowadays again. In all 6 of the studies I've done recently, we've had huge 7 meetings that lasted a couple days where they would go 8 over interradial reliability, things like that. In 9 this particular study I want to say yes, but I don't 10 remember one. Now, I know there were meetings 11 afterwards that would, you know, you would get together 12 and discuss how the drug was doing, what was -- what 13 new was being found out about it. Because, you know, 14 as years go by you find out more and more about 15 pharmaceuticals. 16 Q. You have -- subsequent to your completing 17 this test you have attended meetings sponsored by Eli 18 Lilly where further research regarding the drug was 19 discussed? 20 A. Yes, I have. 21 Q. And how often have you attended those 22 meetings? 23 A. There was one meeting in Charlotte, North 24 Carolina. That was probably about four years ago. 25 There was a meeting in the suburb of Washington D.C. 00084 1 Hartsfield Center or something like that. It was a -- 2 I mean it's right out in the middle of nowhere, but 3 it's this beautiful place to get together and meet and 4 you have no disruption. And these were all weekend 5 meetings. You come in on Friday and leave Sunday. 6 Q. And Lilly sponsored these meetings? They 7 flew you out? 8 A. Lilly sponsored these meetings. And then 9 there was one in San Francisco where they didn't want 10 to pay for it anymore, and I didn't go. 11 Q. Was that more recent? 12 A. This was much more recent, yeah. 13 Q. Other than the clinical monitor who would 14 come out and review the paperwork you think 15 approximately every six weeks or two months, was there 16 any other review of the paperwork that you were aware 17 of? 18 A. Well, the monitor in Indianapolis who was 19 going over this would either call us or send us letters 20 about what she was finding that was wrong. There was 21 that correspondence from Dr. Stark where he wanted me 22 to look over the blood levels because there was 23 something abnormal about them. I recall something -- 24 some of that conversation, but we were unable to figure 25 out why this was an abnormal finding. But that's not 00085 1 the least bit unusual in pharmacology. If you give one 2 person 10 milligrams of thorazine and another 10 3 milligrams, you can get ratings -- readings that are 4 just totally different. 5 Q. Everybody's different. 6 A. Well, especially with these kind of drugs. 7 If I give you lithium and I give you lithium, if I give 8 you the same amount, I'm pretty well going to get the 9 same level. 10 Q. Got you. But not with -- 11 A. But not with these drugs. It depends on 12 how much you drink. It depends on what other medicines 13 you're taking, what you've taken a year ago, how many 14 liver enzymes are induced, how quickly you metabolize, 15 whether you jog or not. Just too much variables 16 present. 17 Q. When somebody from Lilly would call -- let 18 me rephrase it so you understand what I'm asking. 19 You complete X set of paperwork. You send 20 it off to Indianapolis and one of their reviewers there 21 takes a look at it and calls you or your research 22 assistant up and says well, this isn't right. Would 23 they then send you back the original paperwork and have 24 you fix it? 25 A. Sometimes, yeah. Sometimes they would. 00086 1 You would line it out, initial it and then put down the 2 correction. 3 Q. Was there sometimes would they just fill it 4 in there on the basis of a phone conversation? 5 A. I don't think so because then the forms 6 there would not match the forms we had. In other 7 words, I can remember quite vividly you put the forms 8 all back together again when you made your correction. 9 Q. When you did your correction? 10 A. Right. 11 Q. So there shouldn't be a difference between 12 the doctors' forms and the forms that Eli Lilly's got 13 and the forms that are sent to -- 14 A. There should not be. 15 MR. DOWNEY: I don't think I have any further 16 questions, doctor. Really appreciate it. Appreciate 17 your giving us the facility here. 18 I propose a stipulation that we relieve the 19 court reporter of her duty under the code to retain 20 custody of the original transcript of the deposition; 21 once the deposition has been transcribed the original 22 will be forwarded to the general counsel Alan Achen, 23 A-c-h-e-n. 24 What address should it be forwarded to, 25 Alan? 00087 1 MR. ACHEN: You can forward it to Department of 2 Veterans Affairs, Office of the District Counsel, 11000 3 Wilshire Boulevard, L.A., California 90024. 4 MR. DOWNEY: Thank you. And Mr. Achen will make 5 it available to Dr. Gosenfeld for his review. 6 And once it's forwarded to Mr. Achen, give 7 the doctor two weeks to review it? 8 THE WITNESS: That's fine. 9 MR. DOWNEY: And include a self-addressed, 10 stamped envelope so that the original will come back to 11 my office. And I will retain custody of the original 12 and will produce same for any court appearance, 13 hearing, trial or any other proceeding; if the original 14 is unsigned -- and I will also notify defense of any 15 changes that the doctor makes to his transcript within 16 two weeks of receipt. If the deposition is unsigned or 17 somehow lost or destroyed in any manner, then a 18 certified copy of same can be used in place of the 19 original. 20 MR. RIDGE: So stipulated. 21 MR. DOWNEY: Very good. 22 MR. RIDGE: I'd like to get a copy, an ASCII and 23 a shrunk version. 24 (Plaintiffs' Exhibit 1 was marked for 25 identification by the CSR.) 00088 1 (Ending time: 12:35 p.m.) 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ??