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: JANET H. POTVIN, Ph.D 11 DATE: OCTOBER 27, 1993 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 20 (502) 589-2273 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * 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 THE DEPOSITION OF JANET H. POTVIN, Ph.D, 2 TAKEN AT THE OFFICE OF BAKER & DANIELS, 300 NORTH 3 MERIDIAN STREET, SUITE 2700, INDIANAPOLIS, 4 INDIANA 46204, ON OCTOBER 27, 1993; SAID 5 DEPOSITION TAKEN PURSUANT TO NOTICE IN ACCORDANCE 6 WITH THE RULES OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 14 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 15 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 16 MARGARET M. HUFF 17 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 18 INDIANAPOLIS, INDIANA 46285 Page 4 1 MIRA DJORDJIC STEWART 2 COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA CLAUSEN MILLER GORMAN CAFFREY & WITOUS 3 10 SOUTH LASALLE CHICAGO, ILLINOIS 60603 4 Page 5 1 I N D E X 2 3 DEPOSITION OF JANET H. POTVIN, Ph.D 4 5 DIRECT EXAMINATION BY MS. ZETTLER 7 6 CERTIFICATE 159 7 ERRATA 162 8 9 EXHIBITS 10 PLAINTIFFS' EXHIBIT NO. 7 36 11 PLAINTIFFS' EXHIBIT NO. 8 89 12 PLAINTIFFS' EXHIBIT NO. 9 100 13 PLAINTIFFS' EXHIBIT NO. 10 102 14 PLAINTIFFS' EXHIBIT NO. 11 106 15 PLAINTIFFS' EXHIBIT NO. 12 111 16 PLAINTIFFS' EXHIBIT NO. 13 116 17 PLAINTIFFS' EXHIBIT NO. 14 119 Page 6 1 COMES JANET H. POTVIN, Ph.D., CALLED BY 2 THE PLAINTIFFS, AND AFTER FIRST BEING DULY SWORN, 3 WAS DEPOSED AND TESTIFIED AS FOLLOWS: 4 DIRECT EXAMINATION 5 BY MS. ZETTLER: 6 Q. Good morning, Doctor. 7 A. Good morning. 8 Q. How you feeling today? 9 A. Much better. 10 Q. You were pretty sick the last 11 time we had a deposition. 12 A. Yes, I was. 13 Q. Is there any reason why you 14 can't testify today, are you on any medication or 15 is your nasty cold or suffering going to hamper 16 your ability to remember or testify truthfully in 17 any way? 18 A. I don't believe so. 19 Q. Do you remember the ground 20 rules from the last time -- you have to excuse me 21 because I have kind of a cold, too, so I'm going 22 to be kind of losing my voice here and there 23 myself. So if I fade out or you can't understand 24 me, please let me know, okay? Page 7 1 A. I will. 2 Q. Do you remember all the rest of 3 the ground rules we talked about last time about 4 you can take a break or if you have any questions 5 and having to answer verbally instead of shaking 6 your head, things of that nature? If you want me 7 to go through them again, I can. 8 A. I believe I remember. 9 Q. Okay. 10 MR. MYERS: If she forgets, I'll remind 11 her. 12 MS. ZETTLER: Thanks, Larry. 13 Q. Did you have a chance to read 14 your deposition from the last session? 15 A. I did. 16 Q. Did you have any substantive 17 changes that you made to that deposition as far 18 as your answers were concerned? 19 A. No. I completed an errata 20 sheet and signed it. 21 Q. Could I see that real quick? 22 A. Yes. 23 (DISCUSSION OFF THE RECORD.) 24 Q. Since your last deposition, Page 8 1 have you reviewed any documents related to 2 Fluoxetine in preparation for this session? 3 A. No. 4 Q. Are you still working as a 5 medical writer at this point? 6 A. I am. 7 Q. Is your position or your 8 responsibility in your position changed in any 9 way since the last time we met? 10 A. No. 11 Q. I want to clear up a couple of 12 points before we get into the rest of the stuff 13 there, probably more my confusion than anything 14 from the first half, okay. 15 A. Okay. 16 Q. With regards to the ELECT 17 dictionary at Lilly, did you have any 18 responsibility to write a manual of sorts or any 19 other document that would instruct users of the 20 manual in how to use it? 21 A. No. 22 Q. Did you have any writing 23 responsibilities whatsoever with regards to the 24 ELECT dictionary? Page 9 1 A. No. 2 Q. Other than Dr. Tacker that we 3 talked about last time, did you have any contact 4 with any other outside consultants on Fluoxetine? 5 And I'm not limiting that just to the medical -- 6 or to the writing area, for any reason 7 whatsoever. 8 A. I have had contact with other 9 outside writers, but I don't recall whether the 10 other writers actually worked on Fluoxetine. 11 Q. The last time we talked about 12 various reports and manuscripts that you had been 13 involved in regarding Fluoxetine and suicidality. 14 Do you recall that? 15 A. Yes. 16 Q. Did you work with any outside 17 consultants or writers with regards to those 18 reports or manuscripts? 19 A. No, I was at a session where 20 outside consultants were present, but I did not 21 have any contact with them. 22 Q. How about Doctor 23 Heiligenstein's violent aggressive behavior paper 24 and report, did you work with any outside Page 10 1 consultants or writers with regards to that 2 report? 3 A. One of the co-authors of that 4 manuscript is an outside physician, and I met 5 with he and Doctor Heiligenstein concerning the 6 manuscript. 7 Q. Who was that? 8 A. Doctor Coccaro. 9 Q. Anybody else besides Doctor 10 Coccaro? 11 A. Not as an outside consultant on 12 that manuscript. 13 Q. Okay. You mentioned earlier 14 that you were involved in a session where -- or 15 meeting where other consultants, outside 16 consultants, were present. Can you tell me what 17 the subject of that meeting was? 18 A. Yes, it was a review of 19 suicidality data. 20 Q. When did that meeting occur to 21 the best of your recollection? 22 A. I believe it occurred in 1990. 23 Q. Do you remember what month in 24 1990? Page 11 1 A. No, I'm sorry, I don't. 2 Q. Do you remember the time of 3 year, what season, Summer, Spring, Fall, Winter? 4 A. No, I'm sorry, I don't recall. 5 Q. The last time I believe you 6 testified that you thought that Doctor Fawcett 7 had reviewed the suicidality data at some point. 8 Was he at this meeting? 9 A. Yes. 10 Q. Do you remember any of the 11 other outside consultants that were at the 12 meeting? 13 A. I don't recall the other 14 people. 15 Q. Are you familiar with a Doctor 16 Ivan Miller? 17 A. I have heard the name. 18 Q. To your knowledge was he at 19 this meeting? 20 A. Not to my knowledge. 21 Q. How many outside consultants 22 were at the meeting besides Doctor Fawcett? 23 A. I don't recall the specific 24 number of people there. Page 12 1 Q. Do you have any idea if it was 2 more than ten? 3 MR. MYERS: Ten people there or ten 4 consultants? 5 MS. ZETTLER: Ten consultants. 6 A. I believe it was fewer than 7 ten. 8 Q. Fewer than five? 9 A. I don't recall the exact 10 number. 11 Q. Besides the outside consultants 12 and yourself, who else was at the meeting? 13 A. Lilly personnel. 14 Q. Can you give my some names? 15 A. I believe Doctor Masica was at 16 that meeting. 17 Q. Anybody else? 18 A. I do not recall the specific 19 individuals who were there. 20 Q. Was Doctor Beasley there? 21 A. I believe so. 22 Q. How about Doctor Heiligenstein? 23 A. I don't believe. 24 Q. How about Leigh Thompson? Page 13 1 A. I don't know. 2 Q. Laura Fludzinski? 3 A. I don't know. 4 Q. Any other medical writers? 5 A. No. 6 Q. Any statisticians? 7 A. I don't recall the specific 8 individuals who were present at that meeting. 9 Q. I'm not asking for specific 10 individuals, I'm just trying to find out if you 11 recall if there were any statisticians at that 12 meeting. 13 A. I don't know. 14 Q. Okay. How about personnel from 15 the legal department, were they at the meeting, 16 like, for instance, was Ms. Huff at the meeting? 17 A. I don't know. I don't recall 18 the specific individuals who were at the meeting. 19 Q. Did you take notes at the 20 meeting? 21 A. No. 22 Q. Do you know if anybody else 23 took notes at the meeting? 24 A. I don't know who took notes at Page 14 1 the meeting. 2 Q. Do you remember that somebody 3 did take notes, though? 4 A. I don't recall who took notes 5 at that specific meeting. 6 Q. But do you remember that 7 somebody did? 8 A. No, I'm sorry, I don't recall 9 the specific details. 10 Q. Did you ever see meeting 11 minutes that were generated as a result of the 12 meeting? 13 A. I believe a meeting summary was 14 prepared. 15 Q. Do you remember who prepared 16 that summary? 17 A. A summary was prepared after 18 the meeting, but I don't recall who all worked on 19 it. I had some involvement, but I don't remember 20 who all worked on it. 21 Q. You helped on a summary? 22 A. On a summary. 23 Q. What was your involvement in 24 the meeting summary? Page 15 1 A. It was in connection with 2 preparing information for the FDA. 3 Q. When you say meeting summary, 4 you mean a summary of what occurred during the 5 meeting, what was decided, things of that nature; 6 correct? 7 A. The recommendations from the 8 meeting. 9 Q. But what I'm trying to find out 10 is if we're talking about the same thing, 11 something along the lines of meeting minutes, but 12 not something that was submitted, say, to the 13 FDA? 14 A. I did not prepare detailed 15 meeting minutes as I recall. 16 Q. Okay. But the summary you're 17 talking about, is that something that was 18 prepared for use internally as a memorialization 19 of what happened at the meeting or is that 20 something that was submitted to the FDA? 21 A. I am talking about a summary 22 that I believe was submitted to the FDA. 23 Q. Okay. I just wanted to make 24 sure we were on the same thing. As a result of Page 16 1 the meeting on suicidality, a summary was 2 prepared that was submitted to the FDA; correct? 3 A. I'm not absolutely certain, I 4 do not recall. I believe that was the case. 5 Q. What was your involvement in 6 that summary? 7 A. I assisted in the editing and 8 preparation of the document -- or I would have. 9 Q. We seem to have vacillated a 10 little bit. Do you recall working on the 11 preparation of the document or don't you? 12 A. I'm having a difficult time 13 remembering the specific details. 14 Q. How about generally, do you 15 remember generally working on the document? 16 A. I worked on a document on 17 suicidality as I testified, and there was the 18 mention of the consultants using it, and I 19 believe we prepared a summary for that and that 20 was the part of the report submitted to the FDA. 21 Q. You prepared a summary of the 22 meeting with the consultants to include in the 23 report to the FDA? 24 A. I believe there was a brief Page 17 1 summary of the recommendations of that meeting. 2 Q. Okay. The consultants' 3 recommendations? 4 A. Yes. 5 Q. Besides the suicidality meeting 6 with the outside consultants that we were just 7 talking about, did you attend any other meetings 8 at Eli Lilly related to the issue of suicidality 9 and the use of Fluoxetine? 10 A. What type of meetings? 11 Q. Any formal meeting, not just 12 where you meet with, say, one other person, but a 13 formal meeting that was called specifically to 14 discuss the issue of suicidality and the use of 15 Fluoxetine. 16 A. I attended some meetings with a 17 group of Lilly personnel to review suicidality 18 data. 19 Q. When you say reviewed 20 suicidality data, what do you mean? 21 A. To review the results of 22 statistical analyses of data on suicide. 23 Q. Any other suicidality data that 24 you reviewed during the meeting? Page 18 1 A. I'm sorry, I don't understand 2 what you're asking. 3 Q. You said that the purpose of 4 the meetings was to review the results of 5 statistical analyses of data. 6 A. Right. 7 Q. Was there any other data that 8 you looked at other than the statistical 9 analyses? 10 A. I don't believe so. 11 Q. Did you look at any 1639s? 12 A. I did not. 13 Q. Did you look at any narrative 14 summaries regarding patients who suffered 15 suicidal ideation or suicide attempt? 16 A. I did not. 17 Q. How about violent aggressive 18 behavior, did you attend any such meetings with 19 regard to violent aggressive behavior? 20 A. No. 21 Q. How many of these statistical 22 analysis review meetings did you attend? 23 A. I don't recall the number. 24 Q. More than one? Page 19 1 A. More than one. 2 Q. More than five? 3 A. I don't recall the exact 4 number. 5 Q. I'm trying to get a general 6 idea of how many, I'm not asking for an exact 7 number. 8 MR. MYERS: Is there a question? 9 MS. ZETTLER: Well, I'm trying to 10 narrow it down, more than five. 11 MR. MYERS: She said she didn't 12 remember the number. 13 MS. ZETTLER: She said she didn't 14 remember the exact number, I'm trying to get an 15 idea. 16 Q. Was it twenty? 17 A. I'm sorry, I don't remember the 18 number of meetings. 19 Q. More than twenty? 20 A. I don't remember the number of 21 meetings. 22 Q. I'm not asking for a specific 23 number, and I think you would remember if you 24 attended more than twenty meetings reviewing Page 20 1 statistical analyses of information. 2 MR. MYERS: Well, that's not a 3 question. Your statement of what you think she 4 remembers, that's not a question. 5 Q. Was it more than fifty? And 6 again, I'm not asking you for an exact number, 7 I'm just trying to get an idea. 8 MR. MYERS: Doctor, if you know, tell 9 her. If you don't know, tell her that. 10 A. I'm sorry, I don't know the 11 specific number. 12 Q. Again, I'm not asking you for 13 the specific number of meetings, I'm asking you 14 if it's more than fifty. If you can't tell me 15 it's more than fifty, then tell me that. 16 MR. MYERS: I object to the form, I 17 think she's answered this. 18 MS. ZETTLER: Her answer has been 19 consistently she does not recall the specific 20 number of meetings, and I'm consistently telling 21 her that that's not what I'm looking for. 22 MR. MYERS: That's a responsive answer. 23 MS. ZETTLER: I understand that she 24 does not know -- no, it's not. Page 21 1 MR. MYERS: Give her a question. 2 Q. Was it more than twenty 3 meetings? 4 A. I don't recall the number of 5 meetings that were held. 6 Q. Do you recall whether it was 7 more than twenty? 8 MR. MYERS: She's answered -- don't 9 answer that again. Ask her another question, 10 Nancy. 11 Q. Was it more than twenty-five? 12 MR. MYERS: Answer that one. 13 A. I don't remember. 14 Q. But it was more than one; 15 correct? 16 MR. MYERS: She told you that. 17 A. Yes. 18 MS. ZETTLER: I'm asking her the 19 question. 20 MR. MYERS: I understand and she's 21 answered that. 22 Q. Who else attended the meetings? 23 A. I cannot tell you the specific 24 individuals who were there, but the meetings Page 22 1 would have included physicians, statisticians and 2 perhaps clinical research administrators. 3 Q. Was Laura Fludzinski at any of 4 those meetings? 5 A. I don't recall. 6 Q. Doctor Beasley or Doctor 7 Heiligenstein? 8 A. I believe Doctor Beasley was 9 present at some of the meetings. 10 Q. Doctor Dornseif? 11 A. I'm sorry, I don't recall. 12 Q. Doctor Enas? 13 A. I don't recall who was there 14 from the statistician group. 15 Q. Mary Saylor? 16 A. I don't recall. 17 Q. Janet Bosomworth? 18 A. I don't recall. 19 Q. How about Doctor Wheadon, was 20 he there? 21 A. I believe he was present at at 22 least one of the meetings. 23 Q. How about Doctor Kotsanos? 24 A. He was present at one of the Page 23 1 meetings. 2 Q. How about Leigh Thompson? 3 A. I don't recall. 4 Q. How about Jamie Street? 5 A. I don't recall. 6 Q. How about Jeff Powell? 7 A. I don't believe so. 8 Q. Dan Russell? 9 A. I don't know. 10 Q. Melissa Humbert? 11 A. I don't believe so. 12 Q. Why were the meetings held to 13 review suicidality data, why were you reviewing 14 the suicidality data? 15 A. We were reviewing the data to 16 understand the results of the analyses. 17 Q. Were more than one analyses run 18 on the data? 19 A. I'm not familiar with the 20 details of the statistical analyses run on the 21 data. 22 Q. What was your purpose for being 23 at these meetings? 24 A. To review the data with others Page 24 1 so that I could assist in preparing the write-up 2 for the FDA. 3 Q. When was the fist meeting held 4 to review the statistical analysis of suicidality 5 data? 6 A. I don't know the date of the 7 first meeting that was held. 8 Q. Was it before or after the 9 meeting we talked about earlier where outside 10 consultants were at Lilly to discuss suicidal 11 ideation? 12 MR. MYERS: Hold on. The other 13 meetings she talked about were about suicidality, 14 not suicidal ideation. 15 Q. Okay, suicidality in general. 16 A. Repeat the question. 17 Q. Sure. Do you recall whether or 18 not the first statistical meeting was held before 19 or after the suicidality meeting with outside 20 consultants that we discussed earlier? 21 A. I don't know when the first 22 meeting was held to review data. 23 Q. You stated earlier that you 24 reviewed the data to understand it; correct, you Page 25 1 reviewed statistical analysis of the data to be 2 able to understand it; correct? 3 A. Yes. 4 Q. Was there some reason that the 5 data was collected and analyzed and you were 6 seeking to understand it? In other words, was it 7 to be included in a report? 8 A. Yes, it was to be included in a 9 report. 10 Q. What report? 11 A. A review of safety information 12 for the Food and Drug Administration. 13 Q. Were any outside consultants at 14 any of these statistical analysis reviews? 15 A. As I mentioned before, there 16 was a meeting with outside consultants where data 17 were reviewed. 18 Q. Right. I'm talking about the 19 other meetings we were talking about, the ones 20 that were held to review the statistical analysis 21 of the suicidality data. Were there outside 22 consultants in attendance at any of those 23 meetings? 24 A. I don't believe so. Page 26 1 Q. Can you tell me what was 2 discussed within the general category of 3 suicidality at the 1990 meeting where outside 4 consultants were involved? 5 A. Restate your question, please. 6 Q. Sure. I'm trying to find out 7 under the general category of suicidality what 8 was discussed at the meeting where Doctor Fawcett 9 was in attendance and other outside consultants. 10 A. As I recall, we reviewed 11 information from the meta-analysis of US IND 12 placebo and active comparitor controlled trials 13 in depression. 14 Q. Was that the same information 15 that was used by Doctor Beasley in his 16 meta-analysis article that was published in the 17 British Medical Journal? 18 MR. MYERS: When you say same, do you 19 mean the exact same or same type of information? 20 Q. Exact same. 21 A. I don't recall. 22 MS. ZETTLER: Can you read back the 23 question? 24 (THE COURT REPORTER READ BACK THE Page 27 1 REQUESTED TESTIMONY.) 2 Q. Besides the meta-analysis 3 information, what else was reviewed, if anything? 4 A. I believe that's the 5 meta-analysis information. 6 Q. Okay. Do you recall how long 7 that meeting lasted? 8 A. No, I'm sorry, I don't. I was 9 not able to spend the entire time at the meeting. 10 Q. Why not? 11 A. I had other meetings scheduled. 12 Q. Any other meetings related to 13 suicidality or violent aggressive behavior? 14 A. No, not as I recall. 15 Q. Do you recall how long you were 16 able to attend the meeting on suicidality? 17 A. I spent some time there in the 18 morning. 19 Q. What information from the 20 meta-analysis was reviewed at the meeting? 21 A. I believe that we reviewed 22 suicidal act incidence rates. 23 Q. Anything else? 24 A. I believe we reviewed some data Page 28 1 for suicidal ideation, but I don't know what the 2 specific analyses were. 3 Q. Anything else? 4 A. I don't recall any other 5 details. 6 Q. Prior to this meeting or during 7 the meeting, were you given any written 8 materials? 9 A. What type of written materials? 10 Q. Anything written whatsoever. 11 A. I was given a copy of a memo 12 about the meeting. 13 Q. Anything else? 14 A. I don't recall receiving any 15 information prior to the meeting. 16 Q. Were you given any 17 meta-analysis data in written form prior to the 18 meeting or during the meeting? 19 A. I don't recall. 20 Q. How would you review the 21 information if you didn't have it in front of 22 you? 23 A. Are you speaking of the meeting 24 in which the consultants were present? Page 29 1 Q. Right. 2 A. A presentation of the 3 information was given. 4 Q. Who made the presentation? 5 A. I'm trying to recall. I do not 6 recall who made the presentation. 7 Q. Do you recall if it was a Lilly 8 employee or outside consultant? 9 A. It was Lilly people who were 10 presenting the data, I just don't recall who the 11 actual people were. 12 Q. You said earlier that you were 13 given a memo about the meeting prior to the 14 meeting? 15 A. Yes. 16 Q. Do you remember what that memo 17 said? 18 A. No. 19 Q. Did it give more information in 20 general of when the meeting was to be held and 21 where? 22 A. I believe that it indicated the 23 time and location of the meeting and it may have 24 included a list of the consultants who were Page 30 1 attending the meeting. 2 Q. Do you remember who wrote the 3 memo? 4 A. I do not know who signed the 5 memo. 6 Q. Let's go back to the session we 7 talked about earlier that you had with Doctor 8 Coccaro. Is that how you say his name, Coccaro? 9 A. Coccaro. 10 Q. Can you tell me when that 11 session was held, when you had that session? 12 A. I don't recall the date. 13 Q. Was there anybody else that 14 attended that session or was that just you and 15 Doctor Coccaro? 16 A. And Doctor Heiligenstein. 17 Q. And this was regarding the 18 violent aggressive behavior article that was 19 published eventually by Doctor Heiligenstein? 20 A. Right. 21 Q. What was the the purpose of the 22 session? 23 A. To discuss the writing of the 24 article. Page 31 1 Q. When you say discuss the 2 writing of the article, what do you mean? 3 A. To discuss the writing of the 4 article, to talk about the content of each of the 5 sessions of the article. 6 Q. Did you talk about who would do 7 the actual writing? 8 A. We discussed the writing of the 9 article, yes. 10 Q. Who was to do the actual 11 writing of the article? 12 A. It was a joint effort with 13 Doctor Coccaro, Doctor Heiligenstein and I, and 14 Doctor Dornseif. 15 Q. Was Doctor Dornseif at this 16 meeting? 17 A. I don't believe he was. 18 Q. Were you given any specific 19 responsibilities with regards to the writing of 20 the article, in other words given a section to 21 write? 22 A. It was a joint effort, and I 23 don't recall if I was given a specific assignment 24 to write a section at that meeting. Page 32 1 Q. What else was discussed at that 2 meeting? 3 A. As I recall, just the writing 4 of the manuscript. 5 Q. Where within the process of 6 writing was this meeting held, at the beginning 7 before anyone was even started on the article? 8 A. At the beginning. 9 Q. Did you have any other sessions 10 with Doctor Coccaro, Doctor Heiligenstein or 11 Doctor Dornseif regarding the violent aggressive 12 behavior article? 13 A. We had a number of meetings as 14 the article progressed to discuss the article and 15 to review the drafts. 16 Q. Okay. Give me an idea of what 17 some of the various subjects of those other 18 meetings were under the general category of 19 writing the article. 20 A. To discuss the drafts of the 21 article, to review the literature section, to 22 discuss the sections. 23 Q. What did you talk about with 24 regards to the discussion section? Page 33 1 A. I don't recall the specific 2 conversations, but our goal was to prepare the 3 manuscript and to relate it to other published 4 literature. 5 Q. Other literature published by 6 Lilly or other literature published generally? 7 A. Other literature published 8 generally. 9 Q. Would that include literature 10 published by Lilly? 11 A. It could. 12 Q. Have you ever heard of a white 13 sheet? 14 A. No. 15 Q. Was Doctor Heiligenstein's 16 violent aggressive behavior article published? 17 A. Yes. 18 Q. And where was it published? 19 A. I believe it was published in 20 Annals Of Clinical Psychiatry. 21 Q. Was it submitted to any other 22 publication either before or after the Annals Of 23 Clinical Psychiatry? 24 A. I believe it was submitted to Page 34 1 another journal before Annals Of Clinical 2 Psychiatry. 3 Q. Do you remember which journal 4 that was? 5 A. No, I'm sorry, offhand I do 6 not. 7 Q. Was it a domestic United States 8 journal or was it a foreign journal? 9 A. I don't recall what journal it 10 was submitted to. 11 Q. Do you recall whether or not it 12 was in a U.S. journal or was it an outside the 13 U.S. journal? 14 A. I don't recall what it was 15 submitted to. 16 Q. Why wasn't it published in the 17 other publications? 18 A. The journal didn't accept it. 19 Q. Why not? 20 A. I don't recall the specific 21 reasons. 22 Q. Were there attempts made to 23 satisfy the initial journal with regards to any 24 problems that they had with the article, in other Page 35 1 words were there revisions done on the article? 2 MR. MYERS: For the journal that it was 3 first submitted to? 4 MS. ZETTLER: Right. 5 A. I do not recall the details of 6 the submission of that article. 7 Q. Who submitted it? 8 A. Doctor Heiligenstein. 9 Q. Who chose the first publication 10 to which it was submitted? 11 A. I don't know. 12 (PLAINTIFFS' EXHIBIT NO. 7 WAS 13 MARKED FOR IDENTIFICATION AND 14 RECEIVED IN EVIDENCE.) 15 Q. Do you want to take a look at 16 that, Doctor? Do you recall if the initial 17 publication that Doctor Heiligenstein's 18 manuscript was submitted to was the American 19 Journal of Psychiatry? 20 A. I do not recall where the 21 article was first submitted. 22 Q. Do you recognize Exhibit 7, 23 Doctor? 24 A. I do. Page 36 1 Q. Tell me what it is. 2 A. It is a copy of the article 3 Fluoxetine Not Associated With Increased Violence 4 Or Aggression In Controlled Clinical Trials by 5 Doctor Heiligenstein and co-authors. 6 Q. And you're one of the 7 co-authors; correct? 8 A. I am. 9 Q. As a co-author of this article, 10 were you not curious as to why the initial 11 journal that the article was submitted to did not 12 accept it for publication? 13 A. As a co-author of the article, 14 I received a copy of the review comments at the 15 time, however I simply don't recall all the 16 details. 17 Q. Would you have kept a copy of 18 that review in your file? 19 A. I don't recall. 20 Q. If you had kept a copy of that 21 review in your files, would you have turned it 22 over to the legal department at Lilly? 23 A. I would have. 24 Q. Is there any reason why you Page 37 1 would not have kept a copy of that review in your 2 files? 3 A. I can't think of one. 4 Q. On the second page of the 5 exhibit there's a section that talks about review 6 of clinical trial data. Do you see that on the 7 right-hand side? 8 A. Yes. 9 Q. And it also talks about methods 10 of review of the data base, et cetera; correct? 11 A. Right. 12 Q. Who provided you with that 13 information? 14 A. Are you asking for a specific 15 person who provided me the information? 16 Q. Right. 17 A. I believe Doctor Heiligenstein 18 and Doctor Dornseif provided the information. 19 Q. On page three at the bottom of 20 the left-hand column it says data sources; 21 correct? 22 A. Yes. 23 Q. And it talks about, throughout 24 that section, event terms that were searched to Page 38 1 gain information on any possible violent 2 aggressive behavior related to adverse events; 3 correct? 4 A. Right. 5 Q. Who decided that these event 6 terms would be searched as opposed to other event 7 terms? 8 A. Doctor Heiligenstein and 9 perhaps others. 10 Q. What others? 11 A. I don't know if he worked with 12 a group of people to define these analyses or 13 whether it was so many he -- I believe he would 14 have worked with other physicians, but I don't 15 know for certain. 16 Q. Were you involved in coming up 17 with this list of adverse event terms? 18 A. No. 19 Q. Did you ever review any DEN 20 data to see whether or not there were any adverse 21 event terms that you, in your opinion, thought 22 should be included in the analysis? 23 A. I did not review other DEN 24 data. Page 39 1 Q. Were there any event terms that 2 you felt should be included in the analysis other 3 than what's set forth in the article? 4 MR. MYERS: Well, before she answers 5 that, to the extent it may call upon her to give 6 some kind of medical opinion, I object to the 7 form. But if you can answer it, go ahead. 8 A. I can't answer that question. 9 Q. Why not? 10 A. It's outside my area of 11 expertise. 12 Q. I'm not asking as a medical 13 doctor, I'm asking you as an employee at Eli 14 Lilly and as a lay person. Are there any other 15 adverse event terms that were contained in the 16 ELECT dictionary or COSTART dictionary that you 17 were aware of that you felt personally should 18 have been included in this analysis? 19 A. I did not review DEN data, and 20 I'm not familiar with all of the terms in the 21 ELECT dictionary. 22 Q. That's not my question. My 23 question is are there any event terms either from 24 ELECT or COSTART that you yourself feel should Page 40 1 have been included in this analysis? 2 MR. MYERS: That are not in this list 3 here? 4 MS. ZETTLER: Sure. I think that's 5 implicit in the question. 6 MR. MYERS: Well, that's not the way 7 it's going to read in black and white, though. 8 MS. ZETTLER: Okay. 9 A. I believe this list of terms is 10 appropriate. 11 Q. Again, that's not my question. 12 My question is: Are there any event terms that 13 exist in COSTART or ELECT that you personally 14 would have added to the event terms listed on the 15 third page of Exhibit 7? 16 THE WITNESS: Could you read back the 17 question, please? 18 (THE COURT REPORTER READ BACK THE 19 REQUESTED TESTIMONY.) 20 A. No. 21 Q. Are there any other terms that 22 were not necessarily ELECT or COSTART event terms 23 that you would have included in this list as set 24 forth on page three of Exhibit 7? Page 41 1 MR. MYERS: I'm going to object to the 2 form of that question because you're then asking 3 her whether there should be some other 4 methodology employed other than what's listed in 5 the data sources. 6 Q. Let me ask you this: Would you 7 agree that there are at least two sources of 8 information on 1639s of what an event is? 9 A. I'm not familiar with 1639s. 10 Q. Have you ever worked with 11 1639s? 12 A. No. 13 Q. Have you ever worked with a DEN 14 data base? 15 A. No. 16 Q. You have worked with COSTART 17 and ELECT; correct? 18 A. No. 19 Q. You worked with an event term 20 dictionary equivalent to the Food and Drug 21 Administration COSTART dictionary with regards to 22 the writing of this article, did you not? 23 A. No, I worked with listings of 24 adverse events, generally using that dictionary. Page 42 1 Q. And did you ever double-check 2 against the actual dictionary to see if these 3 event terms actually existed in the dictionary? 4 A. Yes. 5 Q. And when you say in here an 6 adverse event term dictionary equivalent to the 7 Food and Drug Administration COSTART dictionary, 8 you are really talking about ELECT, are you not? 9 MR. MYERS: Are you asking does that 10 terminology in the paper equal the ELECT, is that 11 what you're asking her? 12 MS. ZETTLER: I'm asking her what I 13 asked her, the question is clear. 14 MR. MYERS: I don't think it is. 15 MS. ZETTLER: Can you read it back. 16 (THE COURT REPORTER READ BACK THE 17 REQUESTED TESTIMONY.) 18 A. I know that we used a 19 dictionary that's equivalent to the COSTART 20 dictionary, I do not remember if that dictionary 21 was ELECT. 22 Q. Are you familiar with any other 23 dictionaries other than the ELECT dictionary or 24 the COSTART dictionary that was used by Eli Lilly Page 43 1 during the period of time that this article was 2 being written? 3 A. Lilly made a change in the 4 adverse event dictionary, I don't know when the 5 change was made with respect to this paper. 6 Q. When you say made a change, 7 what do you mean? 8 A. I know for certain only that at 9 the time this paper was written, that we used a 10 dictionary equivalent to COSTART. 11 Q. You also said you know there 12 was a change made at some point, and I'm trying 13 to find out what you mean when you say there was 14 a change made. Do you mean that it was changed 15 from the ELECT dictionary to the COSTART or there 16 were changes in the ELECT dictionary? 17 A. I don't know the specific 18 details because I do not work directly with the 19 adverse event dictionaries. 20 Q. I'm not asking for specific 21 details, Doctor. Do you recall whether or not 22 the change you were talking about, the change you 23 brought up in answer to a question, was a change 24 using the ELECT dictionary to the COSTART Page 44 1 dictionary or if it was a change to the ELECT 2 dictionary itself? 3 A. It would be a change from one 4 dictionary to another dictionary. 5 Q. Okay. To your knowledge, 6 besides the ELECT dictionary or COSTART 7 dictionary did Lilly use another dictionary at 8 any time that you were employed by Lilly, that 9 you've been employed by Lilly? 10 A. I don't know periods of time in 11 which specific dictionaries were used and what, 12 if any, other dictionaries were used. 13 Q. How about in the last three or 14 four years, do you recall Lilly using any other 15 dictionaries other than ELECT or COSTART? 16 A. I'm sorry, I don't know the 17 answer to that question. 18 Q. Okay. 19 MS. ZETTLER: Can we take a break? 20 MR. MYERS: Sure. 21 (A SHORT RECESS WAS TAKEN.) 22 Q. Do you know why the clinical 23 trial data base analysis of the Heiligenstein 24 violent aggressive behavior article was limited Page 45 1 to U.S. IND clinical trials? 2 A. No. 3 Q. Who made that decision? 4 A. I don't know. 5 Q. Were you involved in the 6 literature search or a literature search in 7 support of that article? 8 A. I'm sorry, I didn't hear the 9 first part of your question. 10 Q. Were you involved in a 11 literature search in support of this article? 12 A. No. 13 Q. Earlier you testified that you 14 wanted to write the article so it would be in 15 sync with the literature or present literature 16 that was out there on the subject; correct? 17 MR. MYERS: I think she said so that it 18 would be related to the literature. 19 MS. ZETTLER: Related. 20 MR. MYERS: I wrote that down. 21 A. Other co-authors were 22 responsible for literature review. 23 Q. Who was responsible for 24 literature review? Page 46 1 A. I believe it was Doctors 2 Coccaro and Heiligenstein. Doctor Beasley may 3 also have been involved in that. 4 Q. What was Doctor Masica's role 5 in the article? 6 A. I believe that he was involved 7 in the discussions of the analyses. 8 Q. Analyses of what? 9 A. Data. 10 Q. What data? 11 A. The analysis of the adverse 12 event data. 13 Q. From the U.S. IND clinical 14 trials? 15 A. Right. 16 Q. And DEN data base? 17 A. As I told you before, I do not 18 know who specifically was involved in determining 19 the specific adverse events. 20 Q. Right, but on the third page of 21 the article under the data sources question, it 22 says at the bottom of that section the DEN data 23 base was also searched electronically for 24 evidence of the occurrence of adverse -- of the Page 47 1 collection of cluster events. 2 MR. MYERS: Right there. 3 Q. Do you know if Doctor Masica 4 was responsible for that search? 5 A. No. 6 Q. No you don't know or no he 7 wasn't? 8 A. I don't know. 9 Q. Besides literature review, what 10 other role did Doctor Beasley play in this 11 article? 12 A. I believe that Doctor Beasley 13 may have been involved in the design of the 14 analysis. 15 Q. When you say the design of the 16 analysis, what do you mean? 17 A. The choice of the trials, the 18 choice of the terms. But I don't know for sure 19 as I mentioned before. 20 Q. Again, with regards to the 21 literature review, do you know if a search was 22 made for the incidence of homicide or violent 23 aggressive behavior in persons suffering from 24 major depressive disorders? Page 48 1 A. I don't know what terms were 2 included in the literature search. 3 Q. Why was this article written? 4 A. To share information with the 5 scientific community. 6 Q. Was it written in response to a 7 particular event or events? 8 A. I don't know. 9 Q. Do you know why it wasn't 10 written sooner? 11 A. No. 12 Q. Do you know who decided that it 13 needed to be written? 14 A. No. 15 Q. Do you know when it was decided 16 that it needed to be written? 17 A. No. 18 Q. The last time we were together 19 you talked about a standard outline that was used 20 for reports that was submitted to the FDA. Do 21 you recall that? 22 A. Yes. 23 Q. Do you know when that outline 24 was developed? Page 49 1 A. No. 2 Q. Do you know who developed the 3 outline? 4 A. People in the medical and 5 regulatory. 6 Q. Specifically who in medical and 7 regulatory? 8 A. I don't know who specifically 9 developed the outline. 10 Q. When you say people in medical, 11 do you mean clinical research physicians? 12 A. I don't know specifically. 13 Q. How do you know it was people 14 in medical and regulatory? 15 A. Because information about the 16 outline was published in a procedures manual 17 prepared by people in medical and regulatory 18 areas. 19 Q. Is this Lilly's policy and 20 procedure manual? 21 A. Yes. 22 Q. What else was contained in 23 Lilly's policies and procedures manual? 24 A. Information about policies, Page 50 1 procedures and practices to be followed with 2 respect to doing clinical trials and reporting 3 them to the regulatory authorities. 4 MS. ZETTLER: Could you read that back, 5 I didn't hear the last of her answer. 6 (THE COURT REPORTER READ BACK THE 7 REQUESTED TESTIMONY.) 8 Q. Was this a policies, procedures 9 and practice manual given to clinical 10 investigators? 11 A. No. 12 Q. Who was it used by? 13 A. Lilly personnel. 14 Q. Were you involved in writing 15 the manual? 16 A. No, I was involved in revising 17 two chapters of the manual. 18 Q. What chapters? 19 A. One on clinical study reports 20 and one on protocol. 21 Q. When did you revise those 22 chapters? 23 A. I don't know the year that I 24 worked on those. Page 51 1 Q. Do you know if it was before or 2 after 1990? 3 A. I believe it was before. 4 Q. Do you know if it was before or 5 after 1987? 6 A. I don't know if it was before 7 or after 1987 -- I'm sorry, I don't know if it 8 was before 1987, I believe it might have been 9 after. 10 Q. When you said the manual 11 contains information about policies, what 12 policies? 13 A. I believe I answered that 14 question, policies with respect to doing clinical 15 trials and reporting them to regulatory 16 authorities. 17 Q. In particular, what policies 18 related to doing clinical trials? 19 A. How we're going to write the 20 protocols, how we're going to do clinical trials. 21 Q. What aspects of clinical 22 trials? 23 A. All aspects of clinical trials. 24 Q. Would that include Page 52 1 institutional review board approval? 2 A. Yes. 3 Q. Forms required by the FDA to be 4 filled out by clinical investigators such as 1573 5 forms? 6 A. I believe that information was 7 included in the policies manual. But let me 8 clarify. At what time period are we talking 9 about now? 10 Q. At any time. Was there a time 11 when this type of information was not included in 12 the policies, procedures and practices manual? 13 A. There's a new policies manual 14 that's strictly policies. 15 Q. When was that new policies 16 manual created? 17 A. 1993. 18 Q. Do you know why it was created? 19 A. To provide information on 20 global policy. 21 Q. Was the policies, procedures 22 and practices manual prior to 1993 strictly 23 related to Fluoxetine or did it apply to all of 24 Lilly's products? Page 53 1 A. It applies to all of Lilly's 2 products. 3 Q. How about the new policies 4 manual that was written in 1993, is that 5 exclusive to Fluoxetine or does that also apply 6 to all of Lilly's products? 7 A. It applies to all of Lilly's 8 products. 9 Q. Is there still a procedures and 10 practices manual in existence since the creation 11 of the policies manual? 12 A. Yes, it is still in existence. 13 Q. Does that also include the 14 policies or has that section been removed since 15 the new policy manual has been created? 16 A. It still exists in its original 17 form with policies, practices and procedures. 18 Q. What other aspects of clinical 19 trials are included in the policy section of the 20 policies, procedures and practices manual? 21 A. The manual is intended to 22 provide information about all aspects of doing 23 clinical trials, and it has a lengthy table of 24 contents, and I am not certain that I can recite Page 54 1 for you all the types of information it contains. 2 Q. Give me what you recall, that 3 would be fine. 4 MR. MYERS: Other than what she's 5 already told you? 6 MS. ZETTLER: Correct. 7 A. I think the statement that it 8 covers all aspects of doing clinical trials and 9 reporting them. 10 Q. I'm looking for specifics of 11 what you recall with regards to other than that 12 general category of all aspects of clinical 13 trials. I'm trying to find out what you recall 14 specifically. We talked about a couple of areas. 15 A. There's information about 16 starting a clinical trial, information about the 17 phases of clinical trials. 18 Q. When you say phases, you mean 19 like a Phase 1, Phase 2, Phase 3. 20 A. Yes. 21 Q. Anything else? 22 A. IND approval, protocols, IND 23 annual reports, clincial study reports and 24 protocols, I think I already mentioned, clinical Page 55 1 investigator brochures, publications, external 2 communications. 3 Q. When you list all of these 4 categories, are you talking about policies, 5 procedure and practices related to all those 6 categories generally or are these just categories 7 that fit under policies? 8 A. All three. 9 Q. How about grant information 10 related to clinical trials? 11 A. I believe there is information 12 about grants included in that as well, but I'm 13 not certain. 14 Q. How about information regarding 15 contact with medical or safety associations, for 16 instance the National Institute of Mental Health? 17 A. I believe the procedure manual 18 is general, it doesn't cite specific 19 organizations. 20 Q. When you say procedure, you 21 mean policies, procedures and practices, right? 22 A. Right. It's policies, 23 practices and procedures, actually, but that is 24 what I mean. Page 56 1 Q. Are FDA regulations included in 2 the procedures manual? 3 A. I believe there are some 4 excerpts from the regulations in the procedures 5 manual, there are cross-references to sections of 6 the regulations. 7 Q. How many volumes is the manual? 8 A. I believe the last published 9 edition of the manual was one volume. 10 Q. Can you tell me about how thick 11 it is? 12 A. I believe it fits in a 13 three-ring binder. 14 Q. About three inches high? 15 A. I think so. 16 Q. How about prior to the new 17 policies manual being created, was the procedures 18 manual thicker? 19 A. The procedures manual has not 20 been revised recently, so the last published 21 edition is the size it was with respect to the 22 new global policy manual. 23 Q. Are those two manuals meant to 24 be used in conjunction with each other? Page 57 1 A. At the present time, yes. 2 Q. When was the last edition of 3 the procedures manual published? 4 A. I don't know the exact date it 5 was published. 6 Q. Do you know if it was before or 7 after 1990? 8 A. I believe it was after 1990. 9 It may have been '91 or '92 because it's revised 10 and updated periodically. 11 Q. How often is it revised and 12 updated? 13 A. There have been several 14 revisions, I don't know the specific frequency 15 with which that was done. 16 Q. Is it done as a matter of 17 course at intervals, for instance once a year? 18 A. I don't know that, and I don't 19 know what the current plan is. 20 Q. Okay. You said it fits into a 21 three-ring binder. Is that how it comes to you, 22 in a three-ring binder? 23 A. Yes. 24 Q. So if there are revisions, then Page 58 1 you can just put those revisions in wherever they 2 apply within the manual? 3 A. That's correct. 4 Q. How about the new policies 5 manual, about how thick is that? 6 A. It's in a smaller binder, I 7 don't know whether it's a one inch or two-inch 8 binder, but it's smaller than the procedures 9 manual. 10 Q. Prior to the edition of the 11 procedures manual that may have been published in 12 '91 or '92, when was the last edition published? 13 A. I don't know the year of 14 publication of the previous edition. 15 Q. Are these different editions 16 dated? 17 A. Yes, they are, I believe they 18 always have been dated. 19 Q. Do you personally have a copy 20 of the procedures manual? 21 A. I do. 22 Q. Have you had a copy of the 23 procedures manual throughout your employment at 24 Lilly? Page 59 1 A. Since it was instituted, yes. 2 Q. Do you remember when it was 3 instituted? 4 A. No. 5 Q. Do you know if it was before or 6 after 1985? 7 A. I'm sorry, I don't know when 8 the first edition was published. 9 Q. How about the new policies 10 manual, do you have a copy of that? 11 A. I do. 12 Q. Were you asked to turn over 13 copies of the policies, procedures and practices 14 manual or new policies manual to the legal 15 department at Lilly at any time? 16 A. Was I -- restate the question, 17 please. 18 (THE COURT REPORTER READ BACK THE 19 REQUESTED TESTIMONY.) 20 A. I personally was not asked that 21 as I recall. 22 Q. Last time we talked about how 23 the legal department at Lilly has asked that 24 periodically you turn over all Fluoxetine related Page 60 1 documents to the department. Do you remember 2 that? 3 A. Yes. 4 Q. When that request comes down, I 5 believe you said it was on a quarterly basis? 6 A. Yes. 7 Q. Do they ever exclude types of 8 documents that -- in other words say documents, 9 these document you do not have to turn over to 10 us. 11 A. They do not exclude documents. 12 Q. Have you ever turned over 13 information on floppy disks to the legal 14 department related to Fluoxetine? 15 A. I have not. 16 Q. Do you know of anybody who has? 17 A. I do not know. 18 Q. Have you been specifically told 19 not to turn over floppy disks? 20 A. No. 21 Q. Other than the initial 22 publication that Doctor Hieligenstein's violent 23 aggressive behavior article was submitted to and 24 the ultimate journal in which it was published Page 61 1 in, was it submitted to any other publication? 2 A. I believe it was, but I do not 3 recall which journal as I mentioned earlier. 4 Q. So it was submitted to more 5 than two publications? 6 A. No, no -- I'm sorry, I don't 7 recall. 8 Q. You don't recall whether it was 9 submitted to more than two publications? 10 A. I do not recall the publication 11 history on that particular paper. 12 Q. How about Doctor Beasley's 13 meta-analysis article? 14 MR. MYERS: What about it? 15 Q. Do you recall the publication 16 history with regards to that article? 17 A. I believe it was submitted to 18 more than one journal. 19 Q. Do you recall it being 20 submitted to the New England Journal of Medicine? 21 A. Yes, I believe we talked about 22 that last time. 23 Q. Do you recall why it was 24 rejected by the New England Journal of Medicine? Page 62 1 A. No. 2 Q. Was it submitted to any other 3 publications besides the New England Journal of 4 Medicine or the British Medical Journal? 5 A. I don't believe so, I don't 6 recall. 7 Q. Did you communicate with 8 anybody at the New England Journal of Medicine 9 regarding Doctor Beasley's meta-analysis article? 10 A. No, I did not. 11 Q. I'm sorry? 12 A. No, I did not. 13 Q. Do you know why Doctor 14 Beasley's article was limited to a meta-analysis 15 of the U.S. IND clinical trials? 16 A. That data -- those data were 17 available for analysis. 18 Q. There was no data available on 19 OUS Fluoxetine clinical trials at that time? 20 A. Not at the time that the first 21 work was done. There were data, but it had not 22 been prepared for analysis, I believe. 23 Q. What was done to prepare data 24 for analysis? Page 63 1 A. I believe it was tabulated. 2 Q. Anything else? 3 A. Analyzed. 4 Q. Was the OUS clinical trial data 5 available at Lilly to be tabulated and analyzed 6 in 1990? 7 MR. MYERS: What do you mean at Lilly, 8 you mean at Lilly here in Indianapolis? 9 MS. ZETTLER: Anywhere that they had 10 access to it. 11 A. I don't know the answer to the 12 question the way you stated it. 13 Q. What was done to tabulate, tell 14 me what you mean by tabulating the data? 15 A. The data from the OUS trials 16 were not in our IND computerized data base, so 17 the information had to be collected from the case 18 report form manually, and I don't know whether 19 some of the trials were of electronic form or 20 not, I'm not familiar with the details of that 21 practice. 22 Q. When you say that the 23 information from the OUS case report form had to 24 be collected manually, are you talking about the Page 64 1 data collection project in which Lilly employees 2 from Indianapolis went over to the various 3 affiliates outside the U.S. and helped collect 4 and transfer data back to the Indianapolis 5 office? 6 A. I'm not familiar with the 7 details of that process. 8 Q. I'm not asking about the 9 details, I'm asking whether or not you are aware 10 that the OUS clinical trial data was collected 11 and sent back or brought back to Indianapolis by 12 Lilly employees from Indianapolis. 13 MR. MYERS: That's a different 14 question. Go ahead and tell her whether you're 15 aware of that or not. 16 A. I am aware that the data were 17 collected. 18 Q. Why was the OUS data not 19 included in the IND data base? 20 A. The IND data base contains data 21 from trials conducted in the U.S. and Canada 22 under the U.S. IND. 23 Q. To your knowledge, are there 24 any other data bases at Lilly in which Page 65 1 information from clinical trials outside the U.S. 2 were stored such the same as the IND data base? 3 A. I do not know how the data from 4 the OUS trials were handled. 5 Q. You were involved in writing 6 monographs and viewpoints to be used internally, 7 were you not? 8 A. I was involved in writing a 9 product monograph or international monograph on 10 Fluoxetine, yes. 11 Q. How is it that you gathered the 12 data for the monograph? 13 A. Data for that monograph were 14 from U.S. IND controlled clinical trials. And 15 the information came from the U.S. IND data base. 16 Q. So the information from the 17 international monograph was not information that 18 was gleaned from the OUS clinical trials. 19 A. That is correct, at the time 20 we're talking about. 21 Q. Prior to it being tabulated and 22 transferred back to Indianapolis. 23 A. Right. It was the suicidality 24 data that was tabulated and transferred back to Page 66 1 the main office. 2 Q. Specifically suicidality data? 3 A. Right. And I don't know what 4 the dates of the clinical trials were with 5 respect to the preparation of the monograph. 6 Q. Were you involved in any 7 regulatory solutions to foreign countries for 8 registration purposes and safety updates, things 9 of that nature? 10 A. No. 11 Q. Do you know when it was decided 12 that the Beasley meta-analysis article should be 13 written? 14 A. No. 15 Q. Do you know why it was decided 16 that the Beasley meta-analysis article should be 17 written? 18 A. It was a desire to share 19 information with the scientific community. 20 Q. It wouldn't have been in 21 response to the lawsuit that was filed against 22 Lilly with regards to Fluoxetine and suicidality, 23 would it? 24 A. Lilly has a goal to share Page 67 1 information with the scientific community. 2 Q. But they didn't write the 3 article or publish it prior to 1990 when the 4 first lawsuits related to Fluoxetine were filed, 5 did they? 6 A. I can't tell you what the date 7 was when the article was first started. 8 Q. Do you know whether or not the 9 Beasley article was first contemplated before or 10 after Doctor Teicher's article on the emergence 11 of suicidality with the use of Fluoxetine was 12 published? 13 A. I don't know. 14 Q. Were you involved at all in 15 researching, following up on or responding to 16 Doctor Teicher's article in any way? 17 A. I have not responded to Doctor 18 Teicher's article. 19 Q. I'm not talking about you 20 personally, I'm asking if you were involved in 21 any way with the response to Doctor Teicher's 22 article made by Eli Lilly or anyone on behalf of 23 Eli Lilly. 24 MR. MYERS: I object to the form. Page 68 1 That's awfully broad because the suicidality 2 review, if she did any, arguably could be 3 indirectly related. It's an awfully broad 4 question. 5 Q. Do you understand the question, 6 Doctor? 7 A. No. 8 Q. Was a letter written in 9 response to Doctor Teicher's article by somebody 10 at Lilly or on behalf of Lilly? And I mean for 11 publication purposes. 12 A. A letter to whom? 13 Q. Like to the editor of a 14 publication. 15 A. I don't know the specific 16 instance. 17 Q. I'm not assigning it any 18 instances, I'm asking whether or not you were 19 aware of whether or not somebody at Lilly or on 20 Lilly's behalf wrote a letter to an editor of a 21 medical or psychiatric journal responding or 22 commenting on Doctor Teicher's article regarding 23 suicidality and the use of Fluoxetine? 24 A. I can recall a response to a Page 69 1 letter that was published in response to our 2 meta-analysis article. 3 Q. That was a letter by Doctor 4 Oswald? 5 A. Right. 6 Q. So your answer is you don't 7 remember a response to Doctor Teicher's article 8 in letter form? 9 A. I don't recall a specific 10 response to Doctor Teicher's -- it's possible 11 that there was one, but I just don't recall. 12 Q. Have you ever spoken with 13 Doctor Teicher? 14 A. No, I have not. 15 Q. Are you aware of whether or not 16 anybody at Lilly has ever spoken directly to 17 Doctor Teicher? 18 A. I don't know. 19 Q. How about Doctor Jonathan Cole, 20 are you familiar with that name? 21 A. I have heard of that name. 22 Q. Have you ever worked with 23 Doctor Cole or spoken with him? 24 A. No. Page 70 1 Q. Do you recall whether or not 2 there were any revisions made to the 3 meta-analysis article before it was published in 4 the British Medical Journal? 5 A. The article was restyled to 6 meet the Journal's instructions for authors. 7 Q. You said to meet the Journal's 8 instructions for authors? 9 A. Right. 10 Q. What were those instructions? 11 MR. MYERS: Do you want her to tell you 12 what all the instructions were from the British 13 Medical Journal? 14 MS. ZETTLER: The ones that she can 15 remember, Larry, if you recall I'm asking her 16 what she can remember. 17 MR. MYERS: That's not how the question 18 comes out. 19 MS. ZETTLER: She's been doing pretty 20 good at telling me what she remembers and what 21 she doesn't, so I don't think I need to limit my 22 question each time I ask it. Do you want to read 23 back the question. 24 (THE COURT REPORTER READ BACK THE Page 71 1 REQUESTED TESTIMONY.) 2 A. I believe we discussed that 3 previously in the deposition. 4 Q. I don't remember seeing it. If 5 you can point me to a specific site. 6 7 A. I won't keep you waiting. 8 Q. Okay. 9 A. I believe we did discuss it 10 before. It seems to me that the journal had 11 specific guidelines for length, and one of the 12 revisions was to shorten it because of the length 13 guidelines in their instructions. I believe that 14 they also gave specific guidelines for how the 15 tables and figures were to be done, and we 16 revised the paper to make sure that we complied 17 with those instructions. 18 Q. When you say specific 19 guidelines on how the tables and figures were to 20 be done, do you mean the statistical analysis 21 that was involved or are you talking about a 22 cosmetic type of requirement? 23 A. A cosmetic requirement, the way 24 in which the data were displayed. Page 72 1 Q. To your knowledge, did anybody 2 at the British Medical Journal have a problem or 3 take exception with the statistical analysis that 4 was performed on the data on Doctor Beasley's 5 article? 6 A. I don't remember the details of 7 the review or the comments. 8 MS. ZETTLER: Let's break for lunch. 9 MR. MYERS: That's fine. 10 (A LUNCH RECESS WAS TAKEN.) 11 Q. With regards to the articles 12 that are published by Lilly employees, like 13 Doctor Hieligenstein's article and Doctor 14 Beasley's article, who decides who works on the 15 articles? 16 A. I believe it's usually a 17 dicision made by the physician. 18 Q. So, for instance, like Doctor 19 Hieligenstein would say I would like Jan Potvin 20 to work on this or Doctor Masica? 21 A. Uh-huh. 22 Q. I'm sorry? 23 A. Yes. 24 Q. Have you been responsible for Page 73 1 submitting articles for publication? In other 2 words the actual physical transferring of the 3 article to publication, not specifically to 4 Doctor Hieligenstein's or Doctor Beasley's 5 article that we've been talking about, but any 6 articles that were published by Lilly employees. 7 A. You mean have I been the one to 8 write the cover letter and send it to the 9 journal? 10 Q. Right. 11 A. No, I have not. 12 Q. Are you familiar with what the 13 process is generally for submitting a paper for 14 publication? 15 A. I'm not sure that there is one 16 standard process, but I'm familiar with the 17 process that has been used for papers that I've 18 worked on. 19 Q. Can you give me a general idea 20 of how you go about doing that? I'm trying -- I 21 don't know, so I'm just trying to get an idea of 22 how you physically would go about doing that. 23 A. Submitting an article for 24 publication? Page 74 1 Q. Right. Is it a matter of just 2 saying here for your review is an article written 3 by blah blah on the subject of blah blah blah? 4 A. Yes. 5 Q. What -- after the article is 6 submitted, do the various publications have, say, 7 time limits in which you can expect to hear back 8 from them as to whether or not they are going to 9 publish the paper? 10 A. Some journals state a time 11 frame in which authors can expect to hear back 12 from them regarding possible publication or 13 regarding review, but not all journals do this. 14 Q. If a publication is interested 15 in publishing a paper but it wants it, like, for 16 instance, revised such as the BMJ article was 17 revised to fit, like, size and length and things 18 of that nature, how do they usually notify you of 19 that? 20 A. I think you're asking two 21 questions. 22 Q. Okay. 23 A. One, how do they notify you 24 that they want changes, and one, how do they Page 75 1 notify you of their requirements. 2 Q. Okay. 3 A. Each journal publishes a 4 section called instructions for authors, and it 5 may appear in the journal in each issue or once 6 or twice a year, it varies among journals. And 7 in those instructions they state their 8 requirements and give you information about who 9 to submit the paper to for consideration, and 10 whatever guidelines they would like authors to 11 follow with respect to preparing the manuscript. 12 Q. Okay. 13 A. After a manuscript is 14 submitted, it goes through a review process, and 15 then the journal editor communicates with the 16 senior author or the person designated to receive 17 correspondence and sends the reviewer's comments 18 and the journal's decision. And that's a usual 19 or general procedure that is followed. 20 Q. Now what's the procedure at 21 Lilly when a journal responds that they would 22 like an article to be revised? 23 A. I don't believe that Lilly has 24 a standard procedure for dealing with journal Page 76 1 paper reviews. 2 Q. What generally happens? You've 3 already said that it's either the lead author or 4 somebody designated to receive correspondence who 5 would receive correspondence regarding the 6 journal's publication of the article, right? 7 A. Right. 8 Q. What if that -- for instance, 9 what if you were the person designated to receive 10 correspondence, and you received a letter from, 11 say, the British Medical Journal saying that 12 we're interested in publishing this paper, but we 13 need you to make these changes or consider these 14 changes before we will publish it, what would you 15 do? 16 A. I would communicate with all of 17 the co-authors to review the suggested changes to 18 determine which were feasible and reasonable and 19 which were not, and then work with the group to 20 make a decision about the approach to be taken 21 with respect to changes and possible 22 resubmission. 23 Q. Have you in your experience at 24 Lilly ever heard of or been involved with an Page 77 1 incident where a journal has asked for changes to 2 be made in a prospective article and for some 3 reason or another Lilly has refused to make those 4 changes? 5 A. I am not aware of a situation 6 as you described. In any set of reviewer's 7 comments, there will be some things that are 8 reasonable and doable, and some that may not be. 9 Q. Have you been aware of a 10 situation at Lilly where a reviewer's comments 11 have not been doable? 12 A. There are some situations where 13 a reviewer might ask for information but it 14 wasn't collected in the trial so it can't be 15 provided. That would be an example of that type 16 of situation. 17 Q. Have you been involved in such 18 a situation where the journal has then refused to 19 publish the paper? 20 MR. MYERS: If they ask for information 21 that cannot be gotten? 22 MS. ZETTLER: Right. 23 MR. MYERS: As she described? 24 MS. ZETTLER: Right. Page 78 1 A. I don't believe that being 2 unable to provide information that isn't 3 available is in itself a reason that would be 4 used for rejection of the article. 5 Q. What reasons are you aware of 6 that a journal would reject a paper? 7 A. I'm speaking from only my own 8 experience in publishing. 9 Q. That's fine. 10 A. A paper might be rejected 11 because it was unsuitable for the particular 12 journal that it was submitted to. The journal 13 might have published another article on a similar 14 subject recently and not want to publish a second 15 one. I'm sure there are other reasons, but those 16 are two that come to mind. 17 Q. What would make an article 18 unsuitable for publication in a journal? 19 A. It might be a subject matter 20 that was not of interest to the journal. 21 Q. Like say the heart surgery 22 alone for a psychiatric journal? 23 A. That's a reasonable example. 24 Q. Any other reasons why an Page 79 1 article would be unsuitable for a journal? 2 A. If it doesn't match that 3 journal's focus or meet the needs of that 4 audience. 5 Q. Do you recall whether or not 6 the New England Journal of Medicine rejected 7 Doctor Beasley's meta-analysis article outright 8 or if it was a matter of revisions that couldn't 9 be made? 10 A. I don't remember the details of 11 that. 12 Q. Do you recall who it was at 13 Lilly who communicated with the New England 14 Journal of Medicine about the meta-analysis 15 article? 16 A. No, I do not, I do not know who 17 communicated with the journal regarding the 18 article. 19 Q. How is it that Lilly would 20 become aware of, say, a letter like Doctor 21 Oswald's letter criticizing Doctor Beasley's 22 article in the British Medical Journal? 23 MR. MYERS: Do you want to know how 24 they became aware if they did have that letter or Page 80 1 of any letter that comments on an article? 2 Q. Any letter that comments on an 3 article, let's start with that. 4 A. Some journals will send a copy 5 of a letter or article that they are planning to 6 publish to the author of the original article for 7 review and comment. In other cases, an author 8 could become aware of a letter commenting on his 9 or her article by reading it in a publication. 10 Q. Okay. Do you know how Lilly 11 became aware of Doctor Oswald's letter 12 criticizing the meta-analysis article? 13 A. No, I'm sorry, I do not. 14 Q. If Lilly gets a copy of a 15 prospective article given to them by -- sent to 16 them by a journal, you know, for prepublication -- 17 A. Uh-huh. 18 Q. What do you usually do there 19 about the article in reaction to the letter? 20 A. I don't know what is usually 21 done, and there again, I'm not sure that the 22 practice is the same among physicians. 23 Q. Can you tell me what you've 24 seen done in your experience? Page 81 1 A. I can use the approach that you 2 did before, if I were to receive such a letter 3 how would I handle it? 4 Q. Okay. 5 A. And the answer is that I will 6 review it and then review it with the co-authors 7 and come to a decision as to what was the 8 appropriate approach to take. 9 Q. Have you ever seen a situation 10 where a journal has sent a proposed article to 11 Lilly that is critical of Fluoxetine and the 12 journal has given Lilly the option of whether or 13 not it should be published? 14 A. I don't know whether such a 15 situation exists, however the journal peer review 16 process is confidential, and it would be unlikely 17 that a journal would ever do such a thing because 18 of the efforts of the peer review process and the 19 confidentiality of materials that are submitted 20 for consideration to the publication. 21 Q. So when you have a situation 22 where a journal sends a proposed letter that it's -- 23 a prepublication to Lilly, is that after it's 24 gone through the peer review process? Page 82 1 A. I don't know what you mean by 2 prepublication. In the example you used earlier, 3 you were talking about a letter in response to a 4 published article? 5 Q. Right. 6 A. And in the situation that I was 7 thinking of, the journal would have already made 8 a decision to publish it. They would not be 9 asking whether to publish it or not, but simply 10 saying we have made a decision to publish this 11 article, do you wish to respond. 12 Q. Okay. 13 A. And, so, that is quite 14 different from sending an article that's critical 15 to a company saying do you want us to publish it, 16 which would simply not be done as far as I'm 17 aware. 18 Q. In your opinion would that be 19 unethical on the part of a journal to send an 20 article that they were considering publishing 21 that was critical of, say, a drug company's 22 product, and giving that drug company the option 23 as to whether or not an article should be 24 published? Page 83 1 A. I don't believe that journal 2 policy would allow it to do such a thing, but I 3 don't know for sure. 4 Q. My question is: In your 5 opinion, would that be unethical if they were to 6 do something such as that? 7 A. It would depend upon their 8 stated policies and their stated guidelines about 9 how articles are handled. 10 Q. Have you ever heard of a 11 situation where that happened, where a journal 12 has sent an article that they were considering 13 publishing that was critical of a drug product 14 and asked the company for their input as to 15 whether or not it should be published? 16 A. I'm not aware of such a 17 situation. 18 Q. What's the purpose of the peer 19 review process, your understanding of the peer 20 review process? 21 A. Can you clarify your question 22 for me? 23 Q. Sure. You talked earlier about 24 a peer review process at journals to evaluate and Page 84 1 consider for publication various articles that 2 are submitted to it, a journal. My question is: 3 What is the purpose of having that peer review 4 process? 5 A. To ensure the scientific 6 integrity of the work. 7 Q. Any other reasons? 8 A. I believe that's the main 9 focus. 10 Q. Why is that peer review process 11 normally confidential? 12 A. To prevent the untimely and 13 inappropriate disclosure of information before 14 publication. 15 Q. What do you mean by untimely 16 disclosure? 17 A. Scientific journals publish new 18 information, and when a -- say when a publication 19 is being considered for review, it's considered 20 inappropriate to disseminate the results 21 elsewhere, and by making the peer review process 22 confidential, it protects an author's rights, 23 too. 24 Q. What did you mean when you said Page 85 1 an inappropriate disclosure? 2 A. I'm sorry? 3 Q. You said there was to prevent 4 the untimely disclosure and inappropriate 5 disclosure. 6 MR. MYERS: Off the record. 7 (DISCUSSION OFF THE RECORD.) 8 Q. I'm just trying to find out 9 what you meant by inappropriate disclosure. 10 A. Well, the disclosure of 11 information should be through publication in the 12 journal, and if the peer review process were not 13 confidential, then someone might inappropriately 14 disclose the information before it was published 15 in the journal. 16 Q. Have you seen situations at 17 Lilly where authors have sent articles to Lilly 18 before they were published? 19 A. Have I personally seen articles 20 sent before publication? 21 Q. Right. 22 MR. MYERS: Before she answers, let me 23 object to the form. When you say articles, at 24 what point in there, in their life? Page 86 1 MS. ZETTLER: Before they're published. 2 MR. MYERS: Are they just a manuscript, 3 have they been accepted for publication, I mean 4 there's this continuum you all have been talking 5 about, and I just want to know where we are. 6 Q. In any situation, have you seen -- 7 let's start general, okay. Have you seen or have 8 you been aware of a situation where, say, Author 9 A is publishing an article regarding Fluoxetine 10 and he's not a clinical investigator or anybody 11 working under the cap of Lilly, has sent the 12 article to Lilly saying these are the results of 13 the study that I performed and I'm going to try 14 to publish them in, say, the New England Journal 15 of Medicine. Have you ever seen a situation like 16 that? 17 A. I personally am not aware of 18 such a situation, although I suppose it could 19 occur. 20 Q. Do you know how Lilly became 21 aware of Doctor Teicher's article? 22 A. No, I'm sorry, I don't know. 23 Q. Just so I'm not confused, you 24 have seen situations where journals have sent Page 87 1 letters to the editor that they intend to publish 2 to Lilly for their comment; correct? 3 A. I am aware of one such 4 situation. 5 Q. Was that with regards to 6 Fluoxetine? 7 A. It was related to depression, 8 but I don't know if it was specifically 9 Fluoxetine or not. 10 Q. Was it a letter that was 11 critical of an article that was published by 12 Lilly? 13 A. I believe that it was a letter 14 that raised some questions about an article and 15 offered an interpretation of the information. 16 Q. And the article was an article 17 published by Lilly? 18 A. And the article was an article 19 published by Lilly. 20 Q. Was the article related to 21 suicidality? 22 A. No. 23 Q. Violent aggressive behavior? 24 A. No. Page 88 1 Q. Do you know if the letter was 2 published? 3 A. I believe it was. 4 Q. Did Lilly do anything in 5 response to that letter? 6 A. I believe that we wrote a 7 reply, I don't know whether it was published. 8 Q. Does Doctor Friedman ring a 9 bell? 10 A. No. 11 (PLAINTIFFS' EXHIBIT NO. 8 WAS 12 MARKED FOR IDENTIFICATION AND 13 RECEIVED IN EVIDENCE.) 14 A. I thought you said Freeman when 15 you mentioned that. 16 Q. So are you familiar with 17 Exhibit 8? 18 A. Yes. 19 Q. Is this the letter that you 20 were discussing earlier -- actually I should say 21 is this Lilly's response to the letter we were 22 discussing earlier. Is this the letter that 23 constitutes Lilly's reply to the letter we were 24 talking about earlier? Page 89 1 A. I believe it is. 2 Q. So it was Doctor Friedman who 3 had written a letter interpreting a study, an 4 article? 5 A. Commenting, but I don't 6 remember Doctor Friedman's letter specifically. 7 Q. We talked earlier about your 8 testimony that you recall one situation where a 9 letter was sent to Lilly by the journal that was 10 interpreting information that had been published 11 by Lilly; correct? 12 MR. MYERS: The letter was 13 interpreting, not the journal. 14 MS. ZETTLER: Right, the letter was 15 interpreting. 16 Q. Is that correct? 17 A. Yes. 18 Q. Was it -- without recalling 19 specifically what Doctor Friedman's letter was 20 about, was it Doctor Friedman's letter that you 21 were referring to? 22 A. I believe it was. 23 Q. So it was the Journal of 24 Clinical Psychopharmacology that sent the letter Page 90 1 to Lilly? 2 A. The editor of the journal, yes. 3 I believe that is correct. 4 Q. But to your knowledge, the 5 editor or the journal in general had already 6 decided to publish Doctor Friedman's letter 7 before they sent it to Lilly for comment. 8 A. Right, I believe that in the 9 letter that accompanied it, there was a statement 10 that said they were going to publish it and asked 11 if Lilly wanted to reply. I may be wrong on the 12 details. 13 Q. Was the title of Doctor 14 Beasley's meta-analysis article ever different 15 than the meta-analysis title? 16 MR. MYERS: What? 17 Q. Was there a title to that 18 article that was eventually changed to the title 19 as it stands now? I don't have the article with 20 me, I apologize. 21 A. I don't remember. 22 Q. Are you aware of an article 23 that has been or is to be submitted for 24 publication regarding Fluoxetine and suicidality Page 91 1 in OCD patients? 2 A. I'm aware of a manuscript. 3 Q. Were you the lead person on 4 that manuscript? 5 A. Doctor Beasley was. 6 Q. Is that manuscript still in the 7 process of being completed? 8 A. No. 9 Q. Was it scrapped, was the idea 10 scrapped? 11 A. No. 12 Q. Has it been published? 13 A. Yes. 14 Q. Where has it been published? 15 A. The Journal of Affective 16 Disorders. 17 Q. When was it published? 18 A. I believe it may have been 19 published in 1992. 20 Q. How about an article or 21 manuscript regarding Fluoxetine and suicidality 22 and obesity? 23 A. There is a manuscript. 24 Q. Has it been published? Page 92 1 A. It was just published. 2 Q. Where was it published? 3 A. Journal of Clinical Psychiatry. 4 Q. When you say just published, 5 was it within the last sixty days? 6 A. Yes, I believe it was published 7 in September or October. 8 Q. Okay. How about a manuscript 9 regarding Fluoxetine and suicidality in bulimia 10 and nervosa? 11 A. That has also been published. 12 Q. Where? 13 A. The Journal of Clinical 14 Psychiatry. 15 Q. When? 16 A. I don't know the date of the 17 publication. 18 Q. Okay. Was it within the past 19 six months? 20 A. I don't know whether it was 21 published in the end of '92 or early '93. 22 Q. With regards to Doctor 23 Hieligenstein's violent aggressive behavior 24 article, did the group consider using data from Page 93 1 the Lilly testing on animals of Fluoxetine in 2 support of the article? 3 A. I don't know the answer to your 4 question, I'm sorry. 5 Q. You don't know whether or not 6 they did? 7 A. I don't know anything about 8 that. 9 Q. Are you aware of a manuscript 10 that either has been published or is being 11 prepared that relates to improvement in obsessive 12 compulsive symptoms in depressed patients treated 13 with Fluoxetine? 14 A. I'm not aware of such a 15 manuscript. 16 Q. What about a manuscript related 17 to Fluoxetine and suicidality in smoking 18 cessation trials? 19 A. I'm not familiar with a 20 manuscript on that. 21 Q. Have you ever heard the phrase 22 rechallenge study? 23 A. I have heard the phrase. 24 Q. What is your understanding of Page 94 1 what a rechallenge study is? 2 A. I am not certain what is meant 3 by the term rechallenge study. 4 Q. Have you ever heard the phrase 5 validation study? 6 A. No, I don't believe I have. 7 Q. How about pilot study? 8 A. I have heard the term pilot 9 study. 10 Q. What is your understanding of 11 what a pilot study is? 12 A. A pilot study is usually a 13 study in a small number of patients. 14 Q. For what purpose? 15 A. It can be to determine efficacy 16 of a compound in a small number of patients 17 before proceeding to a larger number of patients 18 in a trial. 19 Q. Any other purposes for a pilot 20 study? 21 A. Perhaps for hypothesis testing. 22 Q. Have you heard the term 23 surveillance study? 24 A. I have heard that phrase, but I Page 95 1 don't know what it -- what type of study it 2 specifically refers to. 3 Q. Are you aware of any pilot 4 studies related to Fluoxetine contemplated or 5 performed at Lilly or by Lilly? 6 MR. MYERS: I'm sorry, any -- 7 Q. Any pilot study. 8 A. Would you repeat the question? 9 (THE COURT REPORTER READ BACK THE 10 REQUESTED TESTIMONY.) 11 A. I am aware of one pilot study 12 on Fluoxetine conducted by Lilly. 13 Q. Okay. And what was that pilot 14 study related to? 15 A. Depression. 16 Q. What about depression, what was 17 it testing with regards to depression? 18 A. To determine whether certain 19 factors might be predictive of response to 20 therapy. 21 Q. Is that a study that has been 22 completed? 23 A. Yes, the study has been 24 completed. Page 96 1 Q. When was it completed? 2 A. I don't know the date of 3 completion. 4 Q. Can you tell me what year? 5 A. I don't know whether -- it was 6 completed recently, but I don't know whether that 7 was '92 or '93. 8 Q. Okay. Was that a comparitor 9 study? 10 A. Yes. 11 Q. What factors are you talking 12 about when you say to determine whether factors 13 might be predictive of response to therapy? 14 A. REM latency. 15 Q. When you say REM, you mean 16 rapid eye movement? 17 A. Rapid eye movement latency. 18 Q. Anything else? 19 A. Presence or absence of 20 melancholia. 21 Q. Anything else? 22 A. REM latency probably should be 23 corrected to say shortened REM latency. 24 Q. Where was that trial performed? Page 97 1 A. I do not know. 2 Q. Do you know how many parties 3 were enrolled? 4 A. No, I do not. 5 Q. Do you have the results of the 6 study? 7 A. No, I don't know them in a way 8 that I can summarize them for you. 9 Q. Were you involved in preparing 10 a study report related to that study? 11 A. Yes. 12 Q. Was that study report submitted 13 to the FDA? 14 A. I don't know whether it has 15 been submitted or not. 16 Q. Any other pilot studies that 17 you're aware of? 18 A. I'm sure there are other pilot 19 studies, but I'm not familiar with others. There 20 may have been some pilot studies done earlier in 21 the development of Fluoxetine. 22 Q. To your knowledge are they 23 going to perform the study regarding factors 24 predictive of response to therapy on a larger Page 98 1 scale? 2 A. I do not know. 3 Q. Do you know how many 4 investigators were involved in the study? 5 A. No. 6 Q. Do you remember the names of 7 any of those investigators? 8 A. No. 9 Q. What did you do on the study? 10 A. I reviewed and edited the 11 report. 12 Q. Who had primary responsibility 13 for running that report? 14 A. A statistician and a CRA and 15 Doctor Heiligenstein. 16 Q. Do you know who the CRA and 17 statistician was? 18 A. The statistician is Douglas 19 Faries. 20 Q. F-A-R-I-E-S? 21 A. Yes. 22 Q. Who is the CRA? 23 A. Margaret Pettitt. 24 Q. Are you familiar with the MFSIR Page 99 1 rating scale? 2 A. No. 3 Q. Earlier you testified that you 4 were familiar with the name Ivan Miller; correct? 5 A. I said that I had heard that 6 name. 7 Q. To your knowledge had Doctor 8 Miller ever been a clinical investigator for 9 Lilly? 10 A. I don't know. 11 Q. To your knowledge has Lilly 12 considered performing a rechallenge study on 13 Fluoxetine and suicidality? 14 A. I don't know. 15 (PLAINTIFFS' EXHIBIT NO. 9 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.) 18 Q. Have you had a chance to look 19 at Exhibit 9? 20 A. Yes. 21 Q. Exhibit 9 purports to be a memo 22 dated April 17th, 1991 to yourself and various 23 other people regarding a rechallenge protocol 24 meeting, does it not? Page 100 1 A. It does. 2 Q. Are you familiar with that 3 exhibit? 4 A. No. 5 Q. Did you attend a meeting 6 regarding a rechallenge protocol? 7 A. I don't believe I did. I may 8 have, I don't recall the meeting. 9 Q. Would you know why you would 10 have been listed as a recipient on that memo? 11 A. I was a part of the team 12 working on the suicidality summary information. 13 Q. But you're not aware of any 14 discussion at Lilly regarding a proposed 15 rechallenge protocol regarding Fluoxetine use and 16 suicidality? 17 A. I do not recall the 18 discussions. 19 Q. Have you ever worked with Paul 20 Stark? 21 A. No. 22 Q. Do you know who Doctor Stark 23 is? 24 A. Doctor Stark was in the Page 101 1 Fluoxetine group when I first joined Lilly, but I 2 do not remember having personal contact with him 3 or knowing him. 4 Q. What did Doctor Stark do within 5 the group when you first started working at 6 Lilly? 7 A. I believe he may have been a 8 medical monitor. 9 Q. What is a medical monitor? 10 A. A research physician -- the 11 equivalent of today's research physician title, a 12 person who monitors clinical trials. 13 Q. So like Doctor Beasley? 14 A. Yes, I believe so. That was 15 when I first went there. 16 Q. Have you ever heard of the I 17 saved Prozac team? 18 MR. MYERS: I'm sorry? 19 Q. The I saved Prozac team. 20 A. I don't think so. 21 (PLAINTIFFS' EXHIBIT NO. 10 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. Have you had a chance to look Page 102 1 at Exhibit 11? 2 A. Yes, I have. 3 Q. Why did you feel it was 4 necessary to show this to Ms. Huff? 5 MR. MYERS: That's none of your 6 business. Ask her a question. 7 Q. Do you recognize this? 8 A. I see that it is a messenger 9 message. 10 Q. Do you recognize the exhibit, 11 Doctor Potvin? 12 A. I don't recall the specific 13 message. 14 Q. Do you recall the, quote, I 15 saved Prozac, unquote, team? 16 A. No, I don't. 17 Q. Who is Leigh Thompson? 18 A. Leigh Thompson is a physician 19 who works at Lilly. I don't know his current job 20 title. 21 Q. What was Doctor Thompson's 22 title on August 1st, 1990? 23 A. He was a vice-president. I 24 don't recall his specific title. Page 103 1 Q. The first full paragraph of the 2 E-mail says today a PFC was LRL slash medical's 3 finest hour. What is PFC? 4 A. It's an acronym for a 5 committee, but I don't know what the acronym 6 stands for. 7 Q. Is it a Prozac committee? 8 A. No, I believe it's a -- well, 9 I'm sorry, I don't know what the committee is 10 composed of, but it was a standing committee, not 11 specifically a Fluoxetine committee. 12 Q. Was it a management committee, 13 a management at Lilly committee? 14 A. Yes, I believe it is. 15 Q. Who is Dave Thompson? 16 A. Dave Thompson is a gentleman 17 who works for Lilly, and I believe he was also a 18 vice-president, I do not know what division or 19 what assignment he had at the time of this 20 messenger message. 21 Q. How about Gene Step? 22 A. He is a Lilly employee, I 23 believe he is now retired. 24 Q. What was his position before he Page 104 1 retired? 2 A. He was in the pharmaceutical -- 3 he was upper level management in the 4 pharmaceutical division. 5 Q. Why do you suppose Doctor 6 Thompson thought that Prozac had been saved as of 7 August 1st, 1990? 8 MR. MYERS: I object to the form to the 9 extent that it may call on her to speculate as to 10 what Doctor Thompson was thinking, at least 11 thinking back to 1990. If you know the answer, 12 tell her, don't speculate, though. 13 A. I don't know. 14 Q. Doctor Thompson specifically 15 refers to Doctor Teicher in this memo. 16 MR. MYERS: Where? 17 MS. ZETTLER: Second full paragraph 18 about the middle of page where it says rapid 19 flights to Boston to visit Teicher. 20 Q. Does that give you any 21 indication as to what Doctor Thompson meant by 22 Prozac having been saved? 23 MR. MYERS: Same objection. Tell her 24 if you know. Page 105 1 A. I can't speak for Doctor 2 Thompson, I don't know what he meant. 3 (PLAINTIFFS' EXHIBIT NO. 11 WAS 4 MARKED FOR IDENTIFICATION AND 5 RECEIVED IN EVIDENCE.) 6 Q. Have you had a chance to review 7 Exhibit 12? 8 MR. MYERS: 11. 9 Q. Have you had a chance to review 10 Exhibit 11? 11 A. Yes. 12 Q. Do you recognize the exhibit? 13 A. I do. 14 Q. Can you tell me what it is? 15 A. Yes. It represents some 16 supporting information for the initial 17 manuscript. 18 Q. Is this your handwriting on the 19 first page of the exhibit? 20 A. It is. 21 Q. What do you mean at the top 22 when you say entries included in output not shown 23 in table? 24 A. In the table we included Page 106 1 information for double-blind clinical trials. 2 Some of those clinical trials had extensions that 3 had a separate number -- or designation. Since 4 we were limiting to double-blind trials, the 5 entries shown here are in the output, but not in 6 the table. 7 Q. So how did you know that these 8 were in the output but not in the table? 9 A. By working with the 10 statistician to achieve a correct table that 11 showed double-blind controlled trials and 12 validate it. 13 Q. How did you validate it? 14 A. By working with the 15 statisticians and checking the listing against 16 the computer output -- I'm sorry, the listing 17 that we had created in the table against the 18 output to make sure that the typewritten page was 19 correct. 20 Q. Did you physically check the 21 table with the output? 22 A. Yes. 23 Q. Personally. 24 A. Yes. Page 107 1 Q. And where did you get the 2 output? 3 A. The statistician provided it. 4 Q. From where? 5 A. It's from the host computer 6 system. 7 Q. Is this the clinical trial data 8 base and not the DEN data base? 9 A. I believe that this listing is 10 generated from the clinical trial data base. 11 Q. Okay. Look at the second page 12 of the exhibit. 13 A. Yes. 14 Q. It says aggression in Prozac 15 clinical trials, all trials; correct? 16 A. Yes. 17 Q. And the third column, it says 18 number of patients with event; correct? 19 A. Yes. 20 Q. What is that referring to, what 21 event? 22 A. One of the aggression cluster 23 events as defined in the manuscript, I believe. 24 Q. Okay. Did you double-check Page 108 1 this table against another printout of data to 2 determine whether or not these patients were 3 included in the table? 4 A. I'm sorry? 5 Q. I'm still on the second page of 6 Exhibit 11. 7 A. The statistician and I worked 8 together to check the information. 9 Q. How did you do that physically, 10 is there another table that you worked with or 11 another printout? 12 A. Attached to the end of this 13 exhibit, you have the summary table that was 14 created, and we were double-checking that against 15 raw data listing, and then also against the 16 tables in the report -- or, I'm sorry, in the 17 manuscript. 18 Q. But the summary of clinical 19 trials at the end of the exhibit does not talk 20 about individual patients specifically; correct? 21 A. Correct. The table at the end 22 of the exhibit summarizes some general 23 characteristics about the study as a whole. 24 Q. Were you ever privy to data Page 109 1 from the clinical trial data base related to the 2 individual patients who allegedly suffered these 3 events? 4 MR. MYERS: When you say privy, what do 5 you mean? 6 Q. Did she look at it, receive it, 7 could you have looked at it if you wanted to? 8 A. I did not receive it, I 9 received source information in the form of 10 narrative summaries, and Doctor Heiligenstein 11 prepared a summary table. 12 Q. Of the individual patient 13 situations? 14 A. Right, it's in the manuscript. 15 Q. Okay. I'm talking about prior 16 to the manuscript or in preparation for the 17 manuscript. 18 A. Doctor Heiligenstein prepared 19 the table and supplied it. 20 Q. Okay. Were you ever asked to 21 double-check Doctor Heiligenstein's data as 22 memorialized on page two eighty-nine of the 23 violent aggressive article against the clinical 24 trial data base? Page 110 1 A. That validation would be done 2 by the physician and the statistician. 3 Q. And the statistician in this 4 case was Doctor Dornseif? 5 A. Yes. 6 Q. Did you double-check 7 information related to the DEN data base analysis 8 such as what you did in Exhibit 11? 9 A. I worked with a statistician on 10 the clinical trial data base information. I did 11 not work with the DEN information. 12 Q. Who worked with the DEN, Doctor 13 Masica? 14 A. Doctor Heiligenstein is the one 15 who supplied the information. 16 (PLAINTIFFS' EXHIBIT NO. 12 WAS 17 MARKED FOR IDENTIFICATION AND 18 RECEIVED IN EVIDENCE.) 19 Q. Have you had a chance to look 20 at Exhibit 12? 21 A. Yes. 22 Q. Do you recognize the exhibit? 23 A. I recognize parts of it, but I 24 have not seen the whole thing all together Page 111 1 before. 2 Q. What parts do you recognize? 3 A. I have seen a copy of the 4 letter before, and I have seen -- I remember 5 seeing some notes on the safety packet, but I do 6 not remember seeing all of the material from 7 Doctor Kotsanos before. 8 Q. Okay. What don't you remember 9 seeing? 10 A. I just don't remember seeing 11 the rough handwritten sheets before with the time 12 line. I do remember seeing the second sheet, the 13 topic referring to results, discussion and 14 action, but I don't remember the first table or 15 the last one. I could have seen them before, but 16 I just don't remember. 17 Q. Do you recall having an 18 assignment with regards to the Prozac safety 19 packet related to the DEN data base? 20 A. No, I don't. I know that one 21 of the things that we wanted to do was to provide 22 an explanation of what DEN was, what kind of a 23 data base it was, and its relationship to the 24 clinical trial data base, and I had written such Page 112 1 an explanation. But I do not know what the DEN 2 section of the Prozac safety packet contained. 3 Q. You wrote an explanation of 4 what the DEN data base was and how it compared to 5 the clinical trial data base? 6 A. I worked on a description of 7 that, yes. 8 Q. Did you work on that with Jeff 9 Powell? 10 A. I do not remember working with 11 Jeff on that. 12 Q. Did you work with anybody on 13 writing the explanation regarding the DEN data 14 base as compared to the clinical trial data base? 15 A. I worked with Jim on parts of 16 this, and -- I just don't remember working with 17 Jeff on writing the section on DEN for this. I 18 worked with Jeff, but I don't remember it in this 19 context. 20 Q. Can you give me an idea of what 21 your explanation of the DEN data base and how it 22 compared to the clinical trial data base was? 23 A. The U.S. IND clinical trial 24 data base contains information from clinical Page 113 1 trials conducted in the U.S. and Canada. The DEN 2 data base contains post-marketing safety 3 experience reports collected world wide, and 4 serious adverse event data from clinical trials. 5 Q. Did you go into any more detail 6 than that? 7 A. No. That was the basic extent 8 of the explanation. 9 Q. Where did you get that 10 information? 11 A. From previously written 12 descriptions of those data bases. 13 Q. Written by who? 14 A. I do not know who the authors 15 of the original descriptions were. 16 MS. ZETTLER: Let's take a quick break. 17 (A SHORT RECESS WAS TAKEN.) 18 19 * * * * * * * * * * 20 (PREVIOUS TESTIMONY TAKEN BY 21 MARY KATHLEEN NOLD, COURT REPORTER. 22 THE FOLLOWING TESTIMONY TAKEN BY 23 LINDA BOUR, COURT REPORTER. 24 Page 114 1 * * * * * * * * * * 2 Q. Earlier you testified that -- 3 A. Before you start, I did 4 remember one other thing. 5 Q. Okay. 6 A. You had asked if I remembered a 7 rechallenge study and I did not, but I do 8 remember that Charles was working on a 9 rechallenge protocol and I guess I just thought 10 of protocol rather than study. And I believe he 11 gave me a copy of it, but I don't remember the 12 specific details and I don't know what happened 13 to the protocol. 14 Q. Were you involved at all in 15 writing the protocol? 16 A. No. 17 Q. Why did Charles give you a copy 18 of the protocol? 19 A. To review. 20 Q. Did you review it? 21 A. I don't recall. 22 Q. Did you have any other 23 involvement whatsoever with Dr. Beasley's work on 24 the rechallenge other than reviewing the Page 115 1 protocol? 2 MR. MYERS: Assuming she did review it. 3 MS. ZETTLER: Right. 4 A. No, I didn't have any other 5 work on it. 6 Q. Earlier you testified that you 7 had reviewed some narratives regarding patients 8 who had suffered aggression cluster adverse 9 events; correct? 10 A. Right. 11 Q. Who wrote those narratives if 12 you know? 13 A. I believe Dr. Heiligenstein 14 prepared them. 15 Q. And did you in any way help him 16 prepare those narratives? 17 A. No, I don't believe so. 18 (Deposition Exhibit 13 was marked for 19 identification.) 20 Q. Have you had a chance to review 21 Exhibit 13? 22 A. I have. 23 Q. Do you recognize the exhibit? 24 A. No. Page 116 1 Q. Does this refresh your 2 recollection as to what a white sheet is? 3 A. You asked me earlier if I had 4 heard the term white sheet and I told you I had 5 not and I had not, but I am familiar with the 6 term white paper, and I see that both white paper 7 and white sheet are used in this. 8 Q. What's white paper? What's a 9 white paper? 10 A. A white paper is a brief 11 summary of information about a particular topic, 12 a short monograph. 13 Q. Is that something that's 14 distributed outside of Lilly or is that for 15 internal use? 16 A. A white paper could be either 17 for internal use or distributed to outsiders. 18 Q. What outsiders would be given a 19 copy of a white paper? 20 A. I believe the document 21 mentioned here was for the FDA. 22 Q. Any other outside recipients of 23 white papers? 24 A. I don't know how white papers Page 117 1 are used in a general way. 2 Q. Is white paper an FDA term or 3 is that a Lilly term? 4 A. I think it may be a 5 pharmaceutical industry term. That's where I 6 first heard it. 7 Q. Under the Section 7b in the 8 middle of the page it says -- well, actually it's 9 the second full sentence: "Do we need to qualify 10 this by stating that the classification of 11 serious in this case is based on FOI seriousness 12 (death, hospitalization or disability) rather 13 than regulatory seriousness..." What is FOI 14 seriousness? 15 A. FOI refers to Freedom of 16 Information. I am not familiar with the 17 distinctions that are mentioned here. 18 Q. What's your understanding of 19 what Freedom of Information is? 20 A. Certain information can be 21 obtained from the FDA under the Freedom of 22 Information Act. I do not know anything about 23 FOI seriousness or categorizations that are 24 mentioned here. I'm familiar with the regulatory Page 118 1 definition of serious. There are certain 2 criteria for a serious adverse event which affect 3 the time to report the event to the FDA. 4 (Deposition Exhibit 14 was marked for 5 identification.) 6 Q. Have you had a chance to review 7 Exhibit 14? 8 A. I have. 9 Q. Do you recognize this exhibit? 10 A. No, I do not. 11 Q. At the bottom it says "Regards, 12 Jan, Nel, JJP". 13 A. Yes. 14 Q. Does that indicate to you that 15 you sent this E-mail? 16 A. It does not. 17 Q. Who would have sent this 18 E-mail? 19 A. I do not know the individual 20 who sent this E-mail, but the note states that 21 these are old questions from South Africa, so 22 perhaps the person in South Africa was the sender 23 of this. I do not know beyond Nel. 24 Q. And are you the Jan that's Page 119 1 mentioned at the bottom of the page? 2 A. No, I am not. 3 Q. Do you have any idea why this 4 would have been produced as part of your file? 5 A. No, I do not unless someone 6 thought the Jan and JJP was related to me. I'm 7 sorry, I do not know. 8 Q. Are your initials JJP? 9 A. No, they're JHP. 10 Q. That's what I thought. I 11 believe you testified last time that you worked 12 on clinical investigator manuals in your job at 13 Lilly. 14 A. I have worked on some, yes. 15 Q. And those clinical 16 investigators related to Fluoxetine clinical 17 investigators? 18 A. I have worked on some clinical 19 investigators manuals for Fluoxetine. 20 Q. The information that is 21 presented in those papers, where would you get 22 that information, who would provide that 23 information for you? 24 MR. MYERS: Excuse me, are we talking Page 120 1 about a clinical investigator brochure, same 2 thing? 3 MS. ZETTLER: Yes. 4 MR. MYERS: Are you all talking about 5 the same thing? 6 THE WITNESS: Yes. 7 MS. ZETTLER: Yes. 8 A. I believe we talked about this 9 last time. The current terminology is clinical 10 investigators brochure, but I used it 11 interchangeably with the term clinical 12 investigators manual since that was the previous 13 designation for those. 14 Q. But we understand it to be the 15 same thing? 16 A. It is the same thing. 17 Q. So where would you get the 18 information that would be presented in the 19 clinical investigators manual, such as how many 20 people had been in clinical trials, things of 21 that nature? 22 A. The information would be 23 provided by a CRA in a cluster, the systems 24 analyst and the statistician and the physician, Page 121 1 people from DEN working together as a team. 2 Q. Would that be the same for any 3 safety updates that were filed with regards to 4 Fluoxetine? 5 A. I'm troubled by your use of the 6 term any safety updates. 7 Q. Fluoxetine safety updates. 8 A. Not necessarily. 9 Q. What would be some other 10 sources of information for the safety updates? 11 A. For some safety updates I 12 believe the information is provided by the 13 systems analyst rather than by the full team of 14 people. 15 Q. Can you give me an example of 16 what information would be provided? 17 A. A quarterly adverse events 18 update. 19 Q. What would be included in the 20 quarterly? 21 A. A listing of adverse events 22 from clinical -- from -- it's a listing of 23 clinical trial adverse events, and I am not 24 familiar with the exact form of that listing Page 122 1 because it is new; it's not one that I have 2 worked with yet. 3 Q. Are you currently working on 4 any Fluoxetine clinical trials? 5 A. What do you mean by working on 6 a clinical trial? 7 Q. Well, are you involved in any 8 clinical trials from the medical writing 9 standpoint either in anticipation of a study 10 report being written or a manuscript being 11 prepared or anything of that nature? 12 A. I am currently working on a 13 clinical study report and I am also working on a 14 manuscript. 15 Q. Is that regarding the same 16 trial? 17 A. No. 18 Q. Are those Fluoxetine trials? 19 A. They are Fluoxetine trials. 20 Q. Are they related to depression? 21 A. Yes. 22 Q. Can you tell me what the 23 subject matter of the manuscript is? 24 A. There is a manuscript on Page 123 1 depression in elderly patients. 2 Q. And how about the study report? 3 A. We're writing a report on a 4 study of Fluoxetine in long-term depression, a 5 long-term study in Fluoxetine depression. 6 Q. So patients who had been on 7 Fluoxetine for a long period of time? 8 A. Right, for approximately one 9 year. 10 Q. Okay. Are you aware of a study 11 currently being performed either by or on behalf 12 of Lilly related to Fluoxetine and overdose? 13 A. Yes, I have heard mention of 14 that study. 15 Q. Can you tell me what you know 16 about that study? 17 A. I believe that's a study being 18 conducted in conjunction with the Rocky Mountain 19 Poison Control Center, but that is all I know 20 about it if that's the study to which you refer. 21 Q. Any other studies that you're 22 aware of related to Fluoxetine and overdose? 23 A. No, I'm not aware of any. 24 Q. Earlier you testified that the Page 124 1 new policies manual was created in 1993 to 2 provide global policies, I believe. 3 A. Information about global 4 policies, yes. 5 Q. What are global policies? 6 A. Policies concerning the doing 7 of clinical trials in preparation of materials 8 for regulatory authorities worldwide. 9 Q. So it encompasses more than 10 just the FDA regulations? 11 A. Yes. 12 Q. So when you say global, you 13 really mean global; right? 14 A. Yes. 15 Q. Okay. And does that differ 16 from the policies portion that currently exists 17 in the Policies, Practices and Procedures Manual? 18 A. I am not familiar with the 19 specific similarities or differences. I believe 20 that there may be differences because of the 21 broader application to both U.S. and worldwide 22 regulations. 23 Q. Does the policy section of the 24 Policies, Practices and Procedures Manual talk Page 125 1 about policies as they relate to clinical trials 2 performed outside the United States? 3 A. In which manual? 4 Q. The Policies, Practices and 5 Procedures Manual. 6 A. It was written before the 7 Global Policy Manual and so its primary focus is 8 on U.S. regulations, but I'm not familiar with 9 the individual differences between the two. 10 Q. To your knowledge does Lilly 11 intend to replace the current policies section of 12 the current Policies, Practices and Procedures 13 Manual with the new policies manual? 14 A. I believe that is correct. 15 Q. Do you know when that's 16 supposed to go into effect? 17 A. The new Global Policy Manual is 18 now in effect for policies. 19 Q. Right, but when is the change 20 from the policies section of the Policies, 21 Practices and Procedures Manual as it exists now 22 to the new policies manual supposed to take 23 place? 24 A. It already has taken place. Page 126 1 Q. Earlier I believe you testified 2 that the two work in conjunction with each other 3 now. 4 A. Well, they do because the 5 practices and procedures part is still in place 6 until it's replaced by something else. 7 Q. Okay. So right now the purpose 8 of the new policies manual is to in effect 9 replace the policies portion of the Policies, 10 Practices and Procedures Manual; correct? 11 A. Yes, that's my understanding. 12 I may not be right, but that's the way I 13 understand it. 14 Q. What is your understanding of 15 what meta-analysis means? 16 A. My understanding of 17 meta-analysis is analysis of data across clinical 18 trials. 19 Q. Does it have anything to do 20 with the number of clinical trials that are 21 considered? 22 A. I don't believe that there is 23 any specific number of clinical trials that is 24 required in order for it to be a meta-analysis. Page 127 1 That's a statistical question I believe or could 2 better be answered by a statistician. 3 Q. Okay. Last time we talked 4 about how various manuscripts and reports are 5 prioritized at various times depending on how 6 much manpower they need devoted to them; correct? 7 A. Right. 8 Q. What factors are taken into 9 consideration in prioritizing, say, manuscripts? 10 A. Scientific interest, corporate 11 interest and feasibility to do. 12 Q. Within those three variables do 13 any one or more of them carry more weight than 14 the other? 15 A. The ranking of and of the -- 16 and of the prioritizations was done by a 17 statistician. I don't know about the weighting. 18 Q. Statisticians all across the 19 board or just with Fluoxetine-ranked priorities? 20 A. I was thinking of this with 21 respect to Fluoxetine priorities because that's 22 the only experience that I have. 23 Q. Why is it that a statistician 24 makes the priorities? Page 128 1 A. The statistician wrote the 2 program to calculate priorities based on 3 individual ratings by a committee of people to 4 come up with an average ranking. 5 Q. So there is a program that 6 prioritizes projects with the input from the 7 committee? 8 A. Right. The committee members 9 ranked each of the potential publications on each 10 of the three factors and then their scores were 11 tabulated by a statistician using the program. 12 Q. Is this something that's 13 actually a document that's filled out by the 14 members of the committee? 15 A. It was done on one occasion or 16 two occasions. 17 Q. On what occasions was that 18 done? 19 A. I can't tell you the exact 20 dates. 21 Q. With regards to what articles? 22 A. A series of Fluoxetine 23 articles, all of the work to be published on 24 Fluoxetine. Page 129 1 Q. Were Dr. Beasley's and 2 Dr. Heiligenstein's articles included in that 3 group? 4 A. Yes. 5 Q. Were those all pending 6 publications or manuscripts that were existent at 7 that time or was it just a certain number or 8 certain type of article that was included? 9 A. There was an intent to make a 10 list of all of the planned publications and then 11 to rank and prioritize them for all Fluoxetine. 12 Q. Are you a member of the 13 committee? 14 A. Yes. 15 Q. What factors would be taken 16 into consideration from the corporate point of 17 view? 18 A. Corporate interest in the 19 publications. 20 Q. Such as? 21 A. Perhaps how meaningful the 22 results of a clinical trial might be to the 23 scientific community. 24 Q. Could another factor be whether Page 130 1 or not it's a new product that's just going to be 2 marketed? 3 A. It could be. 4 Q. Could it be an accusation of a 5 serious problem with the drug such as suicidality 6 with Fluoxetine? 7 A. You've said in response to a 8 serious accusation. I think that there is always 9 a desire to share information. I don't know that 10 it's necessarily in response to what you've 11 called a serious accusation. 12 Q. Well, is the desire to share 13 information necessarily a corporate attitude or 14 is that more of a scientific attitude? 15 A. I think it's a combination. 16 Q. Isn't it true that if a product 17 that is on the market such as Fluoxetine is 18 attacked in the media as having some serious 19 problems that it would be a pretty high corporate 20 priority to try to answer that attack? 21 A. I think it's a high priority to 22 provide scientific information about a company's 23 products. 24 Q. Isn't it true that Lilly's Page 131 1 response to the accusation that there was an 2 increased incidence of serious suicidal ideation 3 with the use of Fluoxetine is more than just 4 providing scientific medical literature regarding 5 the issue? 6 MR. MYERS: Well, I object to the form. 7 I think it's vague and ambiguous. What do you 8 mean by something more? I understand the 9 scientific and medical part, but what's the 10 something more? 11 Q. Well, do you understand the 12 question, Doctor? 13 A. You've asked me if it's true 14 and I'm not sure that I do understand your 15 question. 16 Q. Are you aware that Lilly did 17 more than just publish articles related to the 18 scientific aspects of whether or not Fluoxetine 19 was related to an increased incidence of 20 suicidality? 21 A. I am aware of Lilly's 22 publishing scientific articles. 23 Q. Are you aware that they have 24 done other things besides publish articles? Page 132 1 MR. MYERS: Same objection as to the 2 form. Tell her if you know. 3 A. I don't know the answer to your 4 question. 5 Q. Such as present papers at 6 seminars? 7 A. Lilly has presented some papers 8 at seminars; that's also part of providing 9 information to the scientific community. 10 Q. Such as making statements in 11 response to the media? 12 A. I am aware only of the 13 publication of scientific articles and the 14 preparation of material for presentation in 15 professional society meetings. 16 Q. Are you aware of anything else 17 that Lilly's done in response to the accusation 18 that Fluoxetine is disconnected with the 19 increased incidence of serious suicidal ideation? 20 A. There may be other things that 21 Lilly has done, but my responsibilities have been 22 with respect to the papers that we've discussed 23 previously, preparing some information for 24 presentation at the FDA in reports to the FDA and Page 133 1 some information for presentation at a scientific 2 meeting. 3 Q. Other than the presentation of 4 scientific evidence, what other corporate 5 interests would be served by prioritizing 6 articles in a certain manner? 7 A. It would provide resources for 8 a completion of articles or would serve to help 9 provide resources for a completion of articles. 10 Q. That goes under feasibility, 11 does it not? 12 MR. MYERS: Are you telling her or 13 asking her? You asked her a question and she 14 answered it. 15 MS. ZETTLER: I'm asking her. 16 Q. Doctor, would you disagree with 17 me that Eli Lilly is in the business of 18 manufacturing drugs that they could at least in 19 part make money or is it a completely 20 not-for-profit altruistic organization? 21 A. Lilly is in the business of 22 manufacturing drugs for profit, also has a 23 tremendous commitment to research. 24 Q. Okay. But isn't it fair to say Page 134 1 that if one of their best-selling products is 2 being attacked in the media as having a serious 3 problem such as increased suicidality where 4 people are killing themselves on the drug that 5 part of the corporate interest that would be 6 taken into consideration in prioritizing possible 7 publications would be the financial corporate 8 interest involved? 9 A. I believe that Lilly would very 10 much want to review the data and be assured of 11 the science. 12 Q. They're not worried about their 13 profit motives in protecting their interests with 14 regards to the safety of Prozac at all; right? 15 MR. MYERS: Object to the form. It's 16 starting to get argumentative. 17 Q. You can answer it. 18 A. I believe I have. 19 Q. Do you know if that profit was 20 taken into consideration in any way in 21 prioritizing the articles with regards to 22 Fluoxetine and suicidality or violent aggressive 23 behavior? 24 A. I know that the scientific Page 135 1 interests were taken into account, and from my 2 perspective that's all that I know. 3 Q. That's all you took into 4 account when you prioritized? 5 MR. MYERS: No. I object to the form. 6 You're mischaracterizing her testimony. You 7 didn't listen to the answer to the last question. 8 MS. ZETTLER: I did. I listened to it. 9 I heard it. I also heard her testify that she 10 was on a committee that ranked and prioritized 11 articles. 12 Q. Correct? 13 A. Right. 14 Q. And you yourself personally 15 took into consideration those three factors that 16 we discussed earlier; correct? 17 A. That's correct. 18 Q. Scientific? 19 A. Right. 20 Q. Corporate and feasibility; 21 right? 22 A. Right. 23 Q. So I'm asking you now when you 24 would rank these articles -- Page 136 1 A. Right. 2 Q. -- would you take into 3 consideration under the corporate heading solely 4 scientific motives? 5 A. There are more than one factor 6 that constitutes corporate interests as we've 7 been talking about. 8 Q. Well, what are some of those 9 other factors? All we've really been talking 10 about at this point is scientific. 11 MR. MYERS: She's already given you 12 some about ten minutes ago. I object to the 13 form. 14 A. If there is new information 15 about a compound that is of interest to the 16 community at large, then it's important to 17 disseminate that information. 18 Q. What factors are taken into 19 consideration under the scientific heading? 20 A. When the committee prioritized, 21 they set the three main areas: Scientific 22 interest, corporate interest and feasibility. 23 They did not set a series of subcriteria for 24 these, and it's difficult for me to do that now Page 137 1 because I cannot speak for the whole committee. 2 Q. Well, I'm asking about you 3 personally. What did you take into consideration 4 under the scientific interest heading? 5 A. The results of the trial, 6 whether the information would be of benefit to 7 the scientific community, new information to 8 provide to help in the treatment of patients. 9 Q. Anything else? 10 A. Those are things that come to 11 mind. 12 Q. When you say the results of the 13 trial, what do you mean? 14 A. The results of efficacy 15 analyses and safety analyses of a particular 16 clinical trial, the results of meta-analyses of 17 data for the cross trials. 18 Q. To your knowledge has Lilly 19 ever endeavored to publish an article that 20 painted Fluoxetine in a negative light in any 21 way? 22 MR. MYERS: Well, I object to the form 23 and the use of the term painted something in a 24 negative light. That's not a medical or a Page 138 1 scientific term. 2 MS. ZETTLER: And if I asked her a 3 medical or scientific term, Larry, you'd object 4 that it was a medical or scientific term that she 5 wasn't qualified to answer. 6 MR. MYERS: Not necessarily. 7 MS. ZETTLER: I haven't had one 8 question yet that you have, so -- 9 Q. Do you understand the question, 10 Doctor? 11 MR. MYERS: I object to the form of the 12 question. 13 A. Lilly has attempted to publish 14 objective scientific information about the 15 results of its trials. 16 Q. Have you ever seen or heard of 17 an article published by Eli Lilly or anyone on 18 behalf of Eli Lilly that has painted or stated 19 anything negative whatsoever regarding 20 Fluoxetine? 21 MR. MYERS: Same objection. Tell her 22 if you know. 23 A. I believe that Lilly has 24 published objective scientific information. Page 139 1 Q. Have you ever seen an article 2 that has stated that Fluoxetine was less 3 efficacious than another antidepressant on the 4 market? 5 A. I am aware of articles that 6 show that Fluoxetine has comparable efficacy with 7 other antidepressants on the market. 8 Q. Have you ever seen or are you 9 aware of any article that has stated that Lilly -- 10 or that Fluoxetine is less efficacious than any 11 other antidepressant on the market? 12 A. Written by anyone? 13 Q. No, written and published by 14 somebody at Lilly or on behalf of Lilly. 15 A. I don't know whether there are 16 such articles or not. 17 Q. Have you ever seen or heard of 18 an article that was published by Lilly or by 19 anybody on behalf of Lilly that states that 20 Fluoxetine safety profile is not as good as other 21 antidepressants that are currently on the market? 22 A. I am not aware of any data that 23 would support such a statement. 24 Q. That's not my question, Doctor. Page 140 1 My question is: Have you ever heard of or are 2 you aware of any article published by Lilly or 3 anyone on behalf of Lilly that states that 4 Fluoxetine is less safe than any other 5 antidepressant on the market today? 6 MR. MYERS: Object to the form. She's 7 answered it. 8 MS. ZETTLER: No, she hasn't. She has 9 been evasive. 10 MR. MYERS: You don't like the answer, 11 that's all. 12 MS. ZETTLER: You don't like the 13 question. 14 MR. MYERS: If I didn't like the 15 question, I'd tell her not to answer it. She can 16 certainly answer it if she can. 17 MS. ZETTLER: So you're saying that 18 when you tell people not to answer questions, 19 it's because you don't like the questions? 20 MR. MYERS: Maybe among other things. 21 MS. ZETTLER: I'm sure there's plenty 22 of questions that you don't like that -- 23 MR. MYERS: Maybe among other things. 24 MS. ZETTLER: -- it would be more Page 141 1 appropriate to instruct her not to answer on, 2 Larry. Come on. 3 Q. Do you understand the question, 4 Doctor? It's really a simple yes or no. 5 MR. MYERS: It's not necessarily yes or 6 no, so don't feel at all bound to accept that 7 proposition. 8 A. I cannot answer the question as 9 stated. 10 Q. Pardon? 11 A. I cannot answer the question as 12 you've stated it. 13 Q. What part don't you understand? 14 THE WITNESS: Would you read back the 15 question? 16 (The requested question was read back 17 by the reporter.) 18 A. I believe that I answered your 19 question with my previous statement. 20 Q. What was your previous 21 statement? 22 MS. ZETTLER: Go ahead and read it 23 back. 24 (The requested answer was read back Page 142 1 by the reporter.) 2 Q. So that means you haven't seen 3 any? 4 A. I am not aware of any data that 5 support that concept. I believe that's what I 6 said before. 7 Q. Would you agree with me that 8 just because you're not aware of such data 9 doesn't mean that it does not exist? 10 MR. MYERS: Well, I object to the form 11 of the question. The question assumes in its 12 form that it does exist. 13 Q. You can answer it. 14 A. Perhaps you can restate the 15 question. 16 MS. ZETTLER: She can just read it 17 back. 18 (The requested question was read back 19 by the reporter.) 20 A. I think you are making an 21 assumption in your question that I cannot answer. 22 Q. Could it be that you're making 23 an assumption? 24 A. I stated that I am not aware of Page 143 1 data that support the concept that the safety 2 profile of Fluoxetine is less than that of other 3 approved antidepressants. I believe that's the 4 statement that you have made. 5 Q. Have you seen data on every 6 single clinical trial that has been run on 7 Fluoxetine non-depression by Eli Lilly? 8 A. No. 9 Q. Have you seen all information 10 included in all clinical trial databases on 11 Fluoxetine at Lilly? 12 A. No. 13 Q. Have you seen any data 14 contained in the DEN database at Eli Lilly? 15 A. I have seen some DEN data 16 contained in the database at Lilly. 17 Q. Have you seen it all? 18 A. No. 19 Q. In fact, you testified that 20 much of the information that you put into the 21 reports and publications that you have written 22 you've relied on other people to provide to you, 23 haven't you? 24 A. We work as a team and it is the Page 144 1 statistician and the physician, the clinical 2 research administrator and the writer that 3 together provide information for manuscripts and 4 other reports. 5 Q. You haven't done your own 6 statistical analysis of data from any of the 7 clinical trials, have you? 8 MR. MYERS: I object to the form. 9 Don't even answer that. You're not a 10 statistician. 11 MS. ZETTLER: Based on what? 12 MR. MYERS: She's not going to answer 13 you. 14 MS. ZETTLER: Why? 15 MR. MYERS: You're arguing with her. 16 MS. ZETTLER: I am not arguing. 17 MR. MYERS: You're arguing with the 18 witness. Now, move on to something else. 19 MS. ZETTLER: It's a legitimate 20 question, Larry. 21 MR. MYERS: Move on to something else. 22 MS. ZETTLER: No. 23 MR. MYERS: Move on to something else 24 or I'll shut the deposition down and you can go Page 145 1 back to Chicago. 2 MS. ZETTLER: Okay. Let's shut it down 3 then. If you're going to -- 4 MR. MYERS: She's not going to answer 5 that. She's not a statistician. She has 6 testified for two days now that this is a team 7 approach. They have got a statistician, a 8 research physician, a CRA and she is a medical 9 writer, and you're sitting here asking her if she 10 did a statistical analysis. That is asinine at 11 best. Now, she's not going to answer. Ask her 12 another question. You're just trying to harass 13 her and argue with her. 14 Q. Did you personally run any 15 computer queries on any of the databases on 16 Fluoxetine at Eli Lilly? 17 A. No, I did not. 18 Q. And the information that you 19 wrote, for instance in the Heiligenstein article 20 on violent aggressive behavior, was provided to 21 you by various other people, correct, including 22 Dr. Heiligenstein, Dr. Beasley, Dr. Dornseif and 23 Dr. Masica? 24 MR. MYERS: Which portions of the Page 146 1 article? 2 MS. ZETTLER: The portions that we've 3 already talked about, the different areas. 4 Q. The listing of adverse event 5 terms was provided to you by Dr. Beasley and 6 Dr. Heiligenstein; correct? 7 MR. MYERS: She has already answered 8 that. Go ahead and answer it one more time. 9 A. I told you that the information 10 was provided by Dr. Heiligenstien and that I did 11 not know who else had worked with him in 12 developing that list and that perhaps Dr. Beasley 13 had. 14 Q. Okay. And the table that's 15 contained on Page 289 is a table -- the 16 information for that table was provided to you by 17 Dr. Heiligenstein; correct? 18 A. That is correct. 19 Q. Is there any information 20 whatsoever in this article that you yourself 21 developed for the article itself? 22 A. I don't understand by -- what 23 do you mean by information that I developed? 24 Q. Did you compile any information Page 147 1 that is reported in this article personally? You 2 can take another look at the article if that will 3 help. 4 MR. MYERS: Do you understand the 5 question? 6 THE WITNESS: No, I really don't 7 understand. 8 Q. Did you yourself personally 9 research any information that was then contained 10 within this article; in other words, gather any 11 information that is now contained in this article 12 personally? 13 A. Yes. 14 Q. What? 15 A. I collected some of the 16 articles; I reviewed the articles; I worked with 17 others to prepare the manuscript. As I told you 18 earlier, I worked with the statistician and the 19 physicians to prepare the manuscript, to check 20 the information in the manuscript against the 21 data that you have as one of the other exhibits. 22 Q. And you checked information 23 that was provided to you by other people; 24 correct? Page 148 1 A. That is correct. 2 Q. Other than collecting and 3 reviewing articles that are discussed in the 4 Heiligenstein article, what other information did 5 you personally gather in preparation for the 6 article? 7 A. We worked as a team to pull 8 together the information for the article. Each 9 of us had a part to contribute. 10 Q. What was your part to 11 contribute? 12 A. To write the information in a 13 way that it was understandable, to work with 14 others to verify and validate the information. 15 Q. And you've already testified 16 that the information that you validated was 17 information that was provided to you by somebody 18 else; correct? 19 MR. MYERS: She has testified to that 20 four or five times since you've asked her four or 21 five times. 22 MS. ZETTLER: Thanks, Larry. 23 MR. MYERS: She is going to answer it 24 one more time. Go ahead and tell her. Page 149 1 A. I've told you that I worked 2 with others to prepare the manuscript. 3 Q. What I'm trying to understand 4 here from you is other than gathering and 5 reviewing certain articles that were used in 6 conjunction with this article, the Heiligenstein 7 article, what other information have you gathered 8 independent of working with other people that was 9 then used within this article? 10 A. I think you don't understand. 11 The statistician and the physician and the writer 12 and in some cases a clinical research 13 administrator work as a team. It is the 14 statistician's responsibility to provide the 15 results of statistical analyses, to provide the 16 tables, to work with others on the team to assure 17 that the data are validated. 18 It is the clinician's 19 responsibility to provide the clinical 20 perspective. It is the writer's responsibility 21 to make sure that the information is accurate, 22 that it is written in understandable language, 23 that it is correct and complete. 24 Q. So it's your job to take the Page 150 1 information that's provided to you, put it in 2 understandable language and make sure that it's 3 correct and complete? 4 A. Right, to participate in 5 discussion of the analyses to be done that will 6 provide meaningful results. 7 Q. What types of analyses, 8 statistical analyses? 9 A. Statistical analyses. 10 Q. Even though you're not a 11 statistician? 12 A. I am not a statistician and I 13 do not do statistical analyses, but I certainly 14 can work with a team to determine what 15 information would be of interest to review. 16 Q. But your main function was to 17 put it in a readable form and make sure that 18 everything was correct as written? 19 A. To write and to make correct. 20 Q. Did you do any research 21 independent of anybody else on this team 22 regarding the role of serotonin in aggressive and 23 impulsive behavior? 24 A. As a part of the team, I Page 151 1 mentioned to you that I collected articles and 2 that I also reviewed the information in the 3 articles. 4 Q. Anything else specifically with 5 regards to the role of serotonin in aggressive 6 and impulsive behavior? 7 MR. MYERS: She answered that. She 8 said she went and looked at the articles. 9 MS. ZETTLER: I said anything else. 10 A. No. 11 Q. Okay. Did you personally 12 review the clinical trial database for aggression 13 cluster event terms? 14 A. I believe I've already told you 15 that I did not review the clinical trial 16 database. 17 Q. Why is it that marketing would 18 receive a copy of a violent aggressive behavior 19 article? 20 A. It's a part of Lilly's 21 publication approval process to supply a copy of 22 articles to marketing for information. 23 Q. Why? 24 A. So they have information. Page 152 1 Q. On what? 2 A. The particular subject of the 3 publication. 4 Q. Why would marketing need 5 information on the subject of the publication? 6 A. To inform them about what new 7 things are going to appear in the literature 8 eventually. 9 Q. Were there marketing 10 representatives at the prioritization committee 11 meetings? 12 A. There were. There was at least 13 one. 14 Q. To your knowledge has the 15 marketing department at Lilly ever recommended 16 that an article not be submitted for publication? 17 MR. MYERS: Any article? 18 MS. ZETTLER: Any article on 19 Fluoxetine. 20 A. I'm not aware of such a case. 21 Q. To your knowledge has the 22 marketing department or anyone from the marketing 23 department ever requested that a particular 24 article be written on Fluoxetine? Page 153 1 A. Be written by whom? 2 Q. By somebody at Lilly or on 3 behalf of Lilly. 4 A. I believe that it is possible 5 that they have. 6 Q. Are you aware of any specific 7 situation where that has happened? 8 A. I believe that some articles 9 that were written as a follow-up to presentations 10 at a symposium may have been requested by the 11 marketing representative, but I don't know for 12 certain. 13 Q. What symposium? 14 A. There was a symposium in 15 Prague. 16 Q. On Fluoxetine? 17 A. On Fluoxetine. 18 Q. What about Fluoxetine? 19 A. All aspects of Fluoxetine, I 20 believe. 21 Q. When did the Prague symposium 22 take place? 23 A. I don't know the date of the 24 symposium. I believe it was in 1993. Page 154 1 Q. Any other situations that 2 you're aware of where marketing requested that 3 papers be written regarding Fluoxetine? 4 A. I'm sure there is a possibility 5 that there were others, but I don't know of 6 specific instances. 7 Q. Have you done any work at Lilly 8 regarding movement disorders and the use of 9 Fluoxetine? 10 A. No. 11 Q. Have you been involved in the 12 publication of any paper or the writing of any 13 paper or manuscript regarding Fluoxetine in 14 tardivedyskinesia? 15 A. No, I don't believe so. 16 Q. In the Beasley article you 17 testified last time that there was definitions of 18 suicidal ideation and suicidal act. Do you 19 recall that? 20 A. Yes. 21 Q. Who wrote those definitions? 22 A. I'm troubled by your use of the 23 term "who wrote the definitions". I don't know 24 whether you're speaking about who physically put Page 155 1 them into the paper or who decided upon what 2 definition to use. 3 Q. Who decided upon what 4 definition to use? 5 A. I believe that it was 6 Dr. Beasley in consultation with other 7 psychiatrists. 8 Q. Other psychiatrists such as 9 Dr. Fawcett? 10 A. I don't know who all was 11 involved in the development of the definitions. 12 Q. Do you know the names of any of 13 the consultants that Dr. Beasley worked with in 14 deciding what definitions to use? 15 A. I don't know. I believe that 16 he consulted with some of the other psychiatrists 17 at Lilly. I don't know the -- I don't know the 18 answer. 19 Q. Do you know what a Plan D study 20 is? 21 A. It's a study on a marketed 22 compound. 23 Q. Like a Phase IV study? 24 A. Uh-huh. Page 156 1 Q. You have to say yes or no. 2 A. Yes, ma'am. 3 (A discussion was held off the record.) 4 Q. The event terms that were used 5 in the aggression cluster for the Heiligenstein 6 paper, were those event terms that were reported 7 by the patients themselves or was that event 8 terms that were reported by the doctors? 9 A. I believe that adverse event 10 classification terms were used. The patient's 11 actual event terms were recorded, but these 12 mapped classification terms are in the 13 dictionary. 14 Q. So that event terms that were 15 searched would be classification terms or the -- 16 I don't want to say patient's own words because 17 we don't know that for a fact -- but the words 18 used to describe the patient's experiences before 19 they mapped? 20 MR. MYERS: She called them actual 21 terms I think a minute ago. 22 A. I'm sorry, could you repeat 23 your question? 24 Q. Sure. Well, let me ask it this Page 157 1 way: There are event terms; correct? 2 A. Uh-huh. 3 Q. You have to say yes or no. 4 A. Yes. 5 Q. And there are actual terms; 6 right? 7 A. Right. 8 Q. And the actual terms are the 9 terms that are used to report the event to Lilly 10 either by the patient or the doctor, correct, or 11 some other health care professional? 12 A. I believe that is correct. 13 Q. And my question was: Were both 14 of those terms searched or was just the event 15 term searched for the aggression cluster events? 16 A. I believe that event terms were 17 searched. 18 MS. ZETTLER: Okay. That's all I have 19 for now. 20 MR. MYERS: Any questions? 21 MS. STEWART: No. 22 (THE WITNESS WAS EXCUSED.) 23 Page 158 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 (PAGES 1 7 THROUGH 114, AND 159 THROUGH 163) OF 8 JANET H. POTVIN, Ph.D 9 WAS TAKEN BEFORE ME AT THE TIME AND PLACE AS 10 STATED IN THE CAPTION; THAT THE WITNESS WAS FIRST 11 DULY SWORN TO TELL THE TRUTH, THE WHOLE TRUTH, 12 AND NOTHING BUT THE TRUTH; THAT THE SAID 13 PROCEEDINGS WERE TAKEN DOWN BY ME IN STENOGRAPHIC 14 NOTES AND AFTERWARDS TRANSCRIBED UNDER MY 15 DIRECTION; THAT IT IS A TRUE, COMPLETE AND 16 CORRECT TRANSCRIPT OF THE SAID PROCEEDINGS SO 17 HAD; THAT THE APPEARANCES WERE AS STATED IN THE 18 CAPTION. 19 WITNESS MY SIGNATURE THIS THE 6TH DAY OF 20 NOVEMBER, 1993. 21 MY COMMISSION EXPIRES MARCH 10, 1994. 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 159 1 2 3 STATE OF INDIANA ) ) SS: 4 COUNTY OF MARION ) 5 6 I, Linda M. Bour, a Notary Public in and for 7 the County of Marion, State of Indiana at large, 8 do hereby certify that JANET H. POTVIN, Ph.D., 9 the deponent herein was duly sworn to tell the 10 truth, the whole truth, and nothing but the truth 11 in the aforementioned matter; 12 That the foregoing deposition (Pages 115 13 through 158) were taken by me at the offices of 14 of Baker & Daniels, 320 North Meridian Street, 15 Suite 2700, Indianapolis, Marion County, Indiana, 16 on the 27th day of October 1993, said portion 17 commencing at the hour of 2:35 p.m., pursuant to 18 the applicable Rules of Civil Procedure; 19 That said deposition (Pages 115 through 158) 20 were taken down in stenograph notes and 21 afterwards reduced to typewriting under my 22 direction, and that the typewritten transcript is 23 a true record of the testimony given by said 24 deponent; and thereafter presented to said Page 160 1 deponent for her signature; 2 That the parties were represented by their 3 aforementioned counsel. 4 I do further certify that I am a 5 disinterested person in this cause of action; 6 that I am not a relative or attorney of either 7 party, or otherwise interested in the event of 8 this action, and am not in the employ of the 9 attorneys for either party. 10 IN WITNESS WHEREOF, I have hereunto set my 11 hand and affixed my notarial seal this _____ day 12 of ___________, 1993. 13 14 ___________________________ N O T A R Y P U B L I C 15 My Commission Expires: 16 June 19, 1996 17 County of Residence: Marion 18 Page 161 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 I, JANET H. POTVIN, THE UNDERSIGNED 9 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 10 OF MY DEPOSITION AND WITH THE CHANGES NOTED 11 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 12 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 13 THE 6TH DAY OF NOVEMBER, 1993 AT THE TIME AND 14 PLACE STATED THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 162 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 JANET H. POTVIN 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 KENTUCKY AT LARGE Page 163 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Page 164 1 DIRECT EXAMINATIONBY MS. ZETTLER:..................7 2 PLAINTIFFS' EXHIBIT NO. 7.........................36 3 PLAINTIFFS' EXHIBIT NO. 8.........................89 4 PLAINTIFFS' EXHIBIT NO. 9........................100 5 PLAINTIFFS' EXHIBIT NO. 10.......................102 6 PLAINTIFFS' EXHIBIT NO. 11.......................106 7 PLAINTIFFS' EXHIBIT NO. 12.......................111 8 (Deposition Exhibit 13...........................116 9 (Deposition Exhibit 14...........................119 10 COMMONWEALTH.....................................159 11 E R..............................................162 12 13 14 15 16 17 18 Page 165