1 ATTORNEY 1: 2 ATTORNEY 1: 3 ATTORNEY 1: 4 ATTORNEY 1: Goods {HORPBG} 5 [doctor/Dr./Doctor,/Doctor] sale are are my name 6 [a/an] {TKWREG/REU} Green. 7 Q. 8 MS. LAWS: Laws put at? 9 Q. ? 10 MR. GOLDMAN: 11 MR. GOLDMAN: You just didn't want you 12 to have [a/an] {WRAOPBG} to [begin/given] with. 13 MS. LAWS: Laws can we have at same 14 agreement. 15 ATTORNEY 1: 16 ATTORNEY 1: Is do you want to put 17 [you are/you're/your] agreement on the record 18 {HRAUGS}. 19 MS. LAWS: Wheadon made the agreement 20 on the deposition the last [2/two] [day's/days] 21 to reserve all the witness {-PBS},, 22 [objection/ox/oxygen] of one defendant is good as 23 to all [and/on] I assume 24 [that's/that he's/that is] [what/when a] we want Page 1 1 {TPO} do [today//ed to]. 2 ATTORNEY 1: 3 ATTORNEY 1: [That's/That he's/That is] 4 sound good. 5 MR. GOLDMAN: 6 MR. GOLDMAN: 7 [That's/That he's/That is] fine. 8 Q. [Miss/Ms./Miss] sale [err//er], 9 [you are/you're/your] not a medical 10 [figures/physician]? 11 A. No [I mean/I'm/I am] not. 12 Q. Are you a Ph.D? 13 A. No. 14 MR. GOLDMAN: 15 ATTORNEY 2: {P-P} 16 COMES [DEPONENTS NAME], CALLED BY THE 17 [PLAINTIFF/PLAINTIFF/DEFENDANT/DEFENDANTS], AND 18 AFTER FIRST BEING DULY SWORN, WAS DEPOSED AND 19 TESTIFIED AS FOLLOWS: 20 DIRECT EXAMINATION 21 BY [ATTORNEY 1]: 22 COMES [DEPONENTS NAME], CALLED BY THE 23 [PLAINTIFF/PLAINTIFF/DEFENDANT/DEFENDANTS], AND 24 AFTER FIRST BEING DULY SWORN, WAS DEPOSED AND Page 2 1 TESTIFIED AS FOLLOWS: 2 DIRECT EXAMINATION 3 BY [ATTORNEY 1]: 4 COMES [DEPONENTS NAME], CALLED BY THE 5 [PLAINTIFF/PLAINTIFF/DEFENDANT/DEFENDANTS], AND 6 AFTER FIRST BEING DULY SWORN, WAS DEPOSED AND 7 TESTIFIED AS FOLLOWS: 8 DIRECT EXAMINATION 9 BY [ATTORNEY 1]: 10 Q. ? 11 Q. Can you give 12 [you are/you're/your] full name [and/on] address 13 please? 14 A. XXXXXXXXXXXXXXXXXXXXXXXXXXX 15 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 16 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 17 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 18 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 19 XXXXXXXXXX. 20 Q. Are you presently employed 21 [buy/by] {AOE} lie Lilly? 22 A. Yes. 23 Q. [And/On] how long have you been 24 employed [buy/by] {AOE}ly limbly? Page 3 1 A. For [4/four] years. 2 Q. Can you give [meat/meet/me the] 3 [date/day the] you where are hired? 4 A. August [28/twenty-eight], 1989. 5 Q. During your time at Lilly, have 6 you worked with the drug Prozac? 7 A. Yes. 8 Q. [And/On] can you describe 9 [what/when a] [you have/you've] done in 10 [that/this a] regard? 11 A. [I have/I've] primarily worked 12 with physicians [on/and] man description [and/on] 13 [I have/I've] also worked [on/and] reports that 14 have been sent to the FDA. 15 Q. Have you worked with any other 16 drugs other than Prozac? 17 A. Yes. 18 Q. [What/When a] other drugs have 19 you worked with? 20 MR. GOLDMAN: 21 MR. GOLDMAN: Before she answer the 22 [questions/question is], if the drugs are 23 marketed drugs you can tell him [what/when a] the 24 drugs are, if [their/there/they're] drugs under Page 4 1 investigation, you can general describe 2 [them/they mean] but [don't/doesn't] give any 3 specifics because those are trade secrets I don't 4 have a problem with her journal {-P} describes 5 [go/\ing] it. 6 Q. ? 7 ATTORNEY 1: By the way if I {SKW} a 8 question that you {TKOEUPBL} understand let 9 [mean/me know] [and/on] [I will/I'll/ill] try to 10 rephrase it. 11 A. Okay . 12 Q. [So the/Sew the] question is 13 [what/when a] other drugs have you worked with 14 while employed [buy/by] {AOE} lie little 15 [I will/I'll/ill]? 16 A. [I have/I've] worked, 17 [I had/I'd] one project with 18 [in/inch/I know/I knew] {SHREUPB}, [I have/I've] 19 worked one project with perfecting light [and/on] 20 [I mean/I'm/I am] working [on/and] a drug 21 [that/this a] is for the treatment of anxiety. 22 Q. Could you just give me [a/an] 23 [rough/are you familiar] percentage [that/this a] 24 might be hard for you being a stat I say {STEUGS} Page 5 1 [and/on] all but [a/an] [rough/are you familiar] 2 percentage of how much time [you have/you've] 3 spent [and/on] Prozac during your [4/four] years 4 the at {AOE} lie Lilly I {SEUFRPBLGTS/0E8} 5 percent? 6 Q. Prior to working for {AOE} lie 7 Lilly, did you {PWORBG} for any other farm 8 [soothe/suit] calendar company? 9 A. No. 10 Q. Did you work in the profession 11 prior to working for {AOE} lie Lilly? 12 MR. GOLDMAN: Objection to the form 13 [what/when a] do you mean [buy/by] {PHROE} 14 {TPEGS}. 15 ATTORNEY 1: Far [soothe/suit] calendar 16 profession. 17 A. . 18 A. No . 19 Q. Can you give me 20 [you are/you're/your] education {PWRABG} grounds? 21 A. [I have/I've] a bash {HROR} of 22 {SAOEUPBTS} in mathematics [and/on] a masters in 23 is it a {TEUS} sticks. 24 Q. [And/On] where did you get the Page 6 1 masters in {STPA} cities sticks? 2 A. Eye [with a/with an] state 3 university. 4 Q. [And/On] when did you obtain 5 [that/this a] masters? 6 A. In 1987. 7 MR. GOLDMAN: 8 MR. GOLDMAN: Did you go to 9 [understands/under] {STKPWRAD} at eye 10 [with a/with an] state. 11 A. No. 12 MR. GOLDMAN: 13 MR. GOLDMAN: [Objecting/Okay] I'm 14 sorry. 15 Q. Where did you get 16 [you are/you're/your] b s? 17 A. Central {PHEURB} university. 18 Q. Were you employed from 1987 to 19 1989 {SEUFRPBLGTS}? 20 Q. [That's/That he's/That is] 21 after {TKPWAD/WAEUGS} [and/on] before Lilly? 22 A. I graduated in 1989. 23 Q. [Oh,/owe/oh], you did? 24 A. From eye [with a/with an] Page 7 1 state. 2 Q. Okay. . [Dug/did you go] 3 [right/write] from gradution to Lilly? 4 A. Yes. 5 Q. Are you familiar with the 6 [way/weigh] documents have been labeled in the 7 [course/coarse] of this litigation? When I say 8 this litigation, [I mean/I'm/I am] the Prozac 9 litigation in [generally/general]? 10 A. I don't understand the 11 question. 12 Q. Are you a which are 13 [that/this a] {AOE} lie Lilly has been sued 14 regarding Prozac? 15 A. Yes. 16 Q. [And/On] [that/this a] {AOE} 17 lie Lilly has put together a massive amount of 18 documents in order to exchange with the 19 [plaintiff's/plaintiffs]? 20 A. Yes. 21 Q. Are you aware of how those 22 documents are [numbed/numbered]? 23 A. No. 24 Q. Have you ever heard the term a Page 8 1 p z {TPHUFPL}? 2 A. Yes. 3 Q. ? 4 A. Pardon me, a p z stamp, not a p 5 z {TPHUFPL}. 6 Q. Okay. a p z stamp. Are you 7 aware of any [numbers/numbs] {TKPR} a p z stamp 8 that have been used in regard to documents that 9 you maintained? 10 A. No. 11 Q. Do you know what p z 12 [numbers/numbs] are stamped [on/and] any 13 documents that you may have maintained? 14 A. No. 15 Q. [Who's/Whose/Who is] {AL} 16 {SREUPB} h ram {PHREU} [fun/if you know]? 17 A. What would you like 18 [to know/ton]. 19 Q. His position at {AOE} lie 20 Lilly? 21 A. [He's/He is/He say] a manager? 22 Is it a {TEUS} sticks. 23 Q. Is he [you are/you're/your] 24 boss? Page 9 1 A. Yes. 2 Q. How {PWL} [dug/did you go] last 3 e {TPER} I say? 4 A. [He's/He is/He say] a stat 5 {STEUGS} in our {TK-PLT} if an are I he is. 6 Q. Is his will [rang/range/rank] 7 the same as [yourselves/yourself/yours] or is he 8 above or [below/blow] you? 9 A. [He's/He is/He say] above me. 10 Q. [What's/What is] his title 11 {SEUFRPBLGTS} senior stat I say {STEUGS}? 12 Q. [What is your/What's your] 13 title by the way? 14 A. Statistician. 15 Q. Michael {TKPWFPLT} will son? 16 A. [He's/He is] [a/an] {STPAT} I 17 say {STEUGS}. 18 Q. [And/On] his title? 19 A. Stat {EUGS/STEUGS}. 20 Q. [And/On] [what/when a] about 21 somebody with the last name of could the {SAPB} 22 [knows/nose/no, sir]? 23 A. [He's/He is/He say] [a/an] 24 [figures/physician]. Is he an epidemiologist. Page 10 1 A. Yes. 2 Q. Has he worked with Prozac as 3 far as you know? 4 A. Yes. 5 Q. Have you ever [scene/seen] any 6 studies written [buy/by] 7 [doctor/Dr./Doctor,/Doctor] cat {SAPB} 8 [knows/nose/no, sir]? 9 MR. GOLDMAN: 10 MR. GOLDMAN: [I object/I be] 11 [to the/to tell] form [what/when a] do you mean 12 [buy/by] study. 13 Q. Have you ever [scene/seen] the 14 results of any study [that/this a] 15 [doctor/Dr./Doctor,/Doctor] cat {SAPB} 16 [knows/nose/no, sir] performed communicated in 17 [any way/anyway] within the company? 18 A. I still [doesn't/don't] 19 understand study, [what/when a] do you mean 20 [buy/by] study. 21 Q. [What's/What is] 22 [doctor/Dr./Doctor,/Doctor] cat {SAPB} 23 [knows/nose/no, sir] do? 24 A. [I mean/I'm/I am] not sure. Page 11 1 Q. But you do [know/no] 2 [he's/he is/he say] an epidemiologist? 3 A. (Witness moves head up and 4 down.). 5 Q. ? 6 MR. GOLDMAN: 7 MR. GOLDMAN: You need 8 [toss/to say/thoracic outlet syndrome] yes 9 verbal. 10 A. Yes. 11 Q. Do you know if he does 12 [what/when a] an epidemiologist would normally do 13 or does he do something different? 14 MR. GOLDMAN: 15 MR. GOLDMAN: Objection to the form 16 [what/when a] an anticipate [deem/deeply] {OPBLG} 17 I say would normally do is over broad [and/on] 18 entirely vague [and/on] otherwise 19 [you know/you knew/you know,] [defines/defined]. 20 Q. Do you know if 21 [doctor/Dr./Doctor,/Doctor] [k/k/k] performed 22 epidemiological studies as part of his job at 23 {AOE} lie Lilly? 24 A. If I understand [what/when a] Page 12 1 epidemiology is, yes. 2 Q. How about Charles b {SAPL} son? 3 A. [He's/He is/He say] 4 [what's/what is] a question. 5 Q. [What's/What is] his title? 6 A. [He's/He is/He say] a director. 7 Q. Of [what/when a]? 8 A. [I mean/I'm/I am] pretty sure 9 information science [is/\S]. 10 Q. [And/On] how about Janet 11 Bosomworth? 12 A. [She is/She's/She say] a stat I 13 say {STEUGS}. 14 Q. Is she above or [below/blow] 15 you or equal? 16 A. [It's/Its] the same title. 17 Q. How about Greg {REU} even as? 18 A. [He's/He is/He say] director. 19 Q. Had [what/when a]? 20 A. {STPA/TEUS} sticks calendar 21 mathematical [services/surfaces]. 22 Q. Now, {WRL} any of these people 23 [that/this a] [I have/I've] named involved with 24 Prozac [to the/to tell] same degree [that/this a] Page 13 1 [you have been/you've been] over the [past/pass] 2 [4/four] years, in other words have they spent 3 eighty percent of [their/there/they're] time 4 working with Prozac? 5 A. Over the [past/pass] -- these 6 [past/pass] [4/four] years. 7 Q. Yes as long as 8 [you have been/you've been] 9 [their/there/they're]? 10 A. Yes. 11 Q. Which people [and/on] 12 [I will/I'll/ill] name [them/they mean] again if 13 [that will/that'll] help you? 14 A. Uh-huh. 15 Q. Have spent eighty percent of 16 [their/there/they're] time [on/and] Prozac, Greg 17 {REU} even as? 18 A. Can I clarify eighty percent of 19 [their/there/they're] time [that/this a] they 20 have been working or eighty percent over the 21 [past/pass] these [past/pass] [4/four] years. 22 Q. [what I mean/what I'm/what I am] 23 is you over the [past/pass] [4/four] years 24 [you have/you've] estimated [that/this a] Page 14 1 [eighty/80] {PWERS} of [you are/you're/your] time 2 has been [on/and] Prozac? 3 A. Right. 4 Q. [And/On] now [I mean/I'm/I am] 5 asking you to estimate {WHRO} any of these people 6 have spent [and/on] it [doesn't/don't] have to be 7 exactly eighty percent but a large portion of 8 [their/there/they're] time [and/on] Prozac 9 {STKWRAO}? 10 MR. GOLDMAN: 11 A. Between 1987. 12 MR. GOLDMAN: 13 MR. GOLDMAN: Let me object 14 [to the/to tell] form is the question have they 15 spent eighty percent is is the question have they 16 spent a substantial portion of 17 [their/there/they're] time because you asked it 18 [boat/both] [waste/ways/weighs/waist]. 19 ATTORNEY 1: {STPHAOEUPL} ask 20 substantial portion of time, it [don't/doesn't] 21 have to be exactly [eighty/80], [I mean/I'm/I am] 22 trying to [find/fined] out [who's/whose/who is] 23 been involved with Prozac, I don't want to call 24 [anyone/any one] to a deposition [that/this a] Page 15 1 [may be/maybe] only did [1/one] study, do you 2 understand, I want to call somebody 3 [that's/that he's/that is] spent a lot of time 4 studying [and/on] writing about Prozac as 5 [you have/you've] [and/on] [I mean/I'm/I am] just 6 [wandering/wondering] if these people are 7 [that/this a] involved, [objecting/okay]. 8 A. Okay . 9 Q. Greg {REU} even as? 10 A. No. 11 Q. How about Janet Bosomworth? 12 A. Yes. 13 Q. {AL/SREUPB} h ram {PHREU}? 14 A. Yes. 15 Q. Charles {SAPL} son? 16 A. No. 17 Q. [Doctor/Dr./Doctor,/Doctor] cat 18 {SAPB} [knows/nose/no, sir]? 19 A. No. 20 Q. [Mr./Mister] fair I say? 21 A. No. 22 Q. [Mr./Mister] will son? 23 A. Yes. 24 Q. Now, have I [with a/with an] Page 16 1 draw [that/this a]? 2 Q. Are [their/there/they're] any 3 other stat {STEUGS} [is/\S] or directors or 4 managers or senior stat {STEUGS} [is/\S] that 5 have been involved as involved as you are which I 6 have not named? 7 MR. GOLDMAN: 8 MR. GOLDMAN: Before {AOE} answer let 9 me object [to the/to tell] form [to the/to tell] 10 extent [you are/you're/your] asking her for 11 people outside the is it a {STEUSZ} calendar area 12 [and/on] I think your question could be interpret 13 {PRED} as such because you just said managers 14 [and/on] directors, are you talking statistical 15 [types/types]. 16 Q. ? 17 ATTORNEY 1: Yes director of is it a 18 {TEUS} will cities calendar manager in is it a 19 {TEUS} sticks [scene/seen] or stat {STEUGS} 20 [I mean/I'm/I am] asking about is it a disc 21 {SKAL} people. 22 A. [It's/Its] still difficult to 23 answer. I guess my name eighty percent over 24 [4/four] years, if I {KWAUPB/TPAOEU} Page 17 1 [that/this a] time versus [what/when a] if 2 [there is/there's/theirs] somebody relatively 3 [knew/new] that's not as much time. 4 Q. Well, [let's/lets] say 5 [forth/for the/fourth] purpose of the question, 6 somebody spent eighty percent of 7 [their/there/they're] time over 8 [their/there/they're] [past/pass] [2/two] years 9 we would consider [that/this a] person as a good 10 answer [to the/to tell] question? 11 A. Yes. 12 Q. Who would that be? 13 A. Sues [and/on] [hole/whole] man 14 had {O} will {PH} an in. 15 A. Paul row back are {O} about 16 [a/an] {KR} can,, I think 17 [that's/that he's/that is] it. 18 Q. When [fun/if you know] was 19 [miss/Ms./Miss] [hole/whole] man hired [buy/by] 20 {AOE} lie Lilly? 21 A. [2/Two] years ago. 22 Q. [What/When a] about 23 [Mr./Mister] row back? 24 A. [2/Two] years ago. Page 18 1 Q. Were they hired for any 2 specific project as far as you know {EUFRPLTS} 3 not as far as I know? 4 Q. [What/When a] about you, were 5 you hired for any specific project? 6 A. No. 7 Q. When you interviewed with 8 Lilly, were you informed [that/this a] 9 [you would/you'd] be working with Prozac? 10 A. No. 11 Q. When did you [find/fined] out 12 [that/this a] [you would/you'd] be working 13 Prozac? 14 A. I was [probable/probably] a 15 month before coming to Lilly, I was informed 16 [that/this a] there was a good chance 17 [that/this a] [I would/I'd] be [and/on] I didn't 18 know for sure until I came. 19 Q. Do you know if you were if you 20 replaced somebody? 21 A. No , I did not replace. 22 Q. [So/Sew] you were hired as 23 [a/an] [addition/edition] to the Prozac team 24 [is that/is this a] true? Page 19 1 MR. GOLDMAN: 2 MR. GOLDMAN: Object [to the/to tell] 3 form she hadn't said she was hired to be [on/and] 4 the Prozac team whatever [that is/that's] she 5 just said she didn't replace somebody. 6 Q. Were you part of the Fluoxetine 7 continue cluster? 8 A. Yes. 9 Q. [So/Sew] you were hired as 10 [a/an] [addition/edition] [to the/to tell] 11 Fluoxetine continue cluster, that's correct? 12 A. That's correct. 13 Q. Do you know why they needed you 14 in 1989 as [a/an] [addition/edition], when I say 15 [them/they mean], [I mean/I'm/I am] {AOE} lie 16 Lilly? 17 A. No. 18 Q. When you started working with 19 Lilly, did [you have/you've] any type of 20 orientation about Prozac? 21 A. Yes. 22 Q. How long did [that/this a] 23 last? 24 A. [What/When a] specific Page 20 1 orientation are you referring to. 2 Q. [I mean/I'm/I am] did somebody 3 speak to you about Prozac, just anything? 4 A. It still lasting, I still learn 5 about Prozac. 6 Q. [I mean/I'm/I am] talking about 7 within the orientation period did they describe 8 to you [what/when a] [you are/you're/your] job 9 would be? 10 A. Yes. 11 Q. [And/On] what was [that/this a] 12 description? 13 A. The descriptions were 14 [mother/more] a project at a time [so/sew] I was 15 described a particular project [what/when a] 16 [I would/I'd] be [doing/dog] for a project. 17 Q. What was the [first/1st] 18 project that you did? 19 MR. GOLDMAN: 20 MR. GOLDMAN: Any project. 21 ATTORNEY 1: 22 ATTORNEY 1: The first {PROFPBLG} 23 {EBGT}. 24 MR. GOLDMAN: Page 21 1 MR. GOLDMAN: Prozac or any project. 2 ATTORNEY 1: 3 ATTORNEY 1: Prozac 4 A. [I mean/I'm/I am] pretty sure 5 it was working [on/and] a manuscript for that was 6 related to a Prozac question. 7 Q. All right. When you say 8 working [on/and] a manuscript, what will exactly 9 would you do? 10 A. . 11 MR. GOLDMAN: 12 MR. GOLDMAN: [On/And] [that/this a] 13 manuscript or in [generally/general]. 14 ATTORNEY 1: 15 ATTORNEY 1: In [generally/general]. 16 Q. [What/When a] do you mean 17 [buy/by] the phrase working [on/and] a 18 manuscript? 19 A. I [meat/meet/me the] with the 20 [figures/physician] [and/on] {OERL} members of 21 the cluster to talk about which question 22 [that/this a] we want to address [and/on] 23 [then/they knew/they know] I work with 24 [them/they mean] to determine [what/when a] Page 22 1 analyses [that/this a] [weak/week/we can] do to 2 address the question [and/on] 3 [then/they knew/they know] I [usual/usually] run 4 those analyses [and/on] the results from those 5 analyses would be in the manuscript. 6 Q. Okay. . Does that 7 [mean/me know] [that/this a] when you run an 8 analyses [that/this a] the data has already been 9 gathered? 10 A. Yes. 11 Q. Did you [ever/every] design 12 [a/an] [clinically/clinical] trial or helped to 13 design [a/an] [clinically/clinical] trial? 14 A. Yes. 15 Q. Did you ever help to design 16 [a/an] [clinically/clinical] trial where Prozac 17 was going to be the drug that was tested? 18 A. Yes. 19 Q. [And/On] [what/when a] 20 [clinically/clinical] trial was [that/this a]? 21 A. There was [a/an] 22 [clinically/clinical] trial [that/this a] the 23 name of it [I mean/I'm/I am] pretty sure was 24 Fluoxetine continue versus placebo in are Page 23 1 [patience/patients/patient's/patient] with 2 cardiac [a/an] {REUT} [masks/mass]. 3 Q. Bites [way/weigh] when 4 [you would/you'd] work [on/and] these manuscript, 5 were you considered an author? 6 A. Yes. 7 Q. How many man {SKREUPTS} if any 8 have been published [buy/by] medical 9 {SKWRURPBLS}? 10 MR. GOLDMAN: 11 MR. GOLDMAN: With her name [on/and] 12 [them/they mean]. 13 ATTORNEY 1: 14 ATTORNEY 1: 15 Q. Yes with [you are/you're/your] 16 name [on/and] [them/they mean] as author? 17 A. Does [that/this a] 18 [clued/include/conclude] psychiatric 19 {SKWRURPBLS}. 20 Q. Yes {SEUFRPBLGTS} about 21 [6/six]? 22 Q. [Down/Do you know] if there was 23 a FDA advisory committee meeting in or about 24 [September/except] of 1991 regarding Prozac? Page 24 1 A. Yes. 2 Q. Did you have anything to do 3 with [that/this a] meeting? 4 A. Yes. 5 Q. Could you describe 6 [what/when a] you did? 7 A. I helped prepare for it. 8 Q. How did you help prepare for 9 it? 10 A. We analyze {DZ} the data in 11 [probable/probably] [ever/every] shape form it 12 could possibly be analyzed. 13 Q. Did you present all of the 14 analyzed data which was analyzed in [ever/every] 15 shape [and/on] form, did you {PRPBTS} all those 16 {SHAEUPS} [and/on] forms [to the/to tell] FDA? 17 A. Most as part of a document, not 18 necessarily [for the/forth/fourth] presentation. 19 Q. But [their/there/they're] were 20 some [and/on] sayings [is/\S] which were not 21 presented [to the/to tell] FDA is that correct? 22 A. [Probable/probably]. 23 Q. Do you recall which [and/on] 24 sayings [is/\S] were not presented Page 25 1 [to the/to tell] FDA? 2 A. No. 3 Q. What was the {PURPTS} of this 4 advisory committee as far as you know? 5 MR. GOLDMAN: 6 MR. GOLDMAN: The committee 7 [generally/general] or the committee meeting in 8 [except/September] of '91. 9 ATTORNEY 1: 10 ATTORNEY 1: The committee meeting in 11 [except/September] of '91. 12 A. [I would/I'd] [guess/guest] 13 that was the FDA response to the concerns 14 [that/this a] [they've/they have] heard [and/on] 15 [so/sew] they formed the committee to address the 16 question. 17 Q. Are you talking about the 18 suicide issue? 19 A. Yes. 20 Q. When were you [first/1st] 21 [told/totaled] to [begin/given] preparing if you 22 were [told/totaled] at all {TPAOR} this 23 [except/September], '91 committee meeting? 24 A. We in some [sense/since], a lot Page 26 1 of [what/when a] we were working [on/and] was 2 preparing for the meeting before we even 3 [knew/new] the meeting was going to exist 4 [so/sew] this specific meeting, we started to 5 prepare for it when we [first/1st] heard of it. 6 Q. [Down/Do you know] when that 7 was? 8 A. No. 9 Q. Were you given any specific 10 assignments times to appropriate for 11 [that/this a] meeting? 12 A. Yes, I guess. 13 Q. Do you know what they were? 14 A. They were answering trying to 15 analyze the data [and/on] answer the 16 [questions/question is] the physicians would 17 have. 18 Q. Do you mean [that/this a] in 19 preparing [forth/for the/fourth] meeting, 20 [that/this a] physicians wanted to make {S-RPB} 21 {STAEULGTS} [so/sew] they immediate 22 [today//ed to] run an analysis of the data 23 [and/on] [you would/you'd] do [that/this a]? 24 A. No . Page 27 1 MR. GOLDMAN: 2 MR. GOLDMAN: Hold [on/and] 3 [I object/I be] [to the/to tell] form she said 4 the physicians have [questions/question is] 5 [and/on] [you have/you've] now said {-LTD} 6 physicians {WAPBTSZ} [had/dollars] to make 7 statements [and/on] you thus [miss/Ms./Miss] 8 character [raced/raised] her testimony. 9 Q. [What/When a] exactly do you 10 mean? 11 A. Most specifically 12 [they would/they'd] try to anticipate any 13 [questions/question is] [that/this a] 14 [may be/maybe] asked from the FDA or any 15 [questions/question is] [that/this a] 16 [they would/they'd] have in [their/there/they're] 17 mind [and/on] we would address those 18 [questions/question is]. 19 Q. Where did the data come from 20 [that/this a] [you would/you'd] analyze in 21 preparation for this [9/nine] '91 meeting? 22 A. . 23 A. The data [that/this a] 24 [I would/I'd] use would would come from the Page 28 1 systems analyst. 2 Q. Do you know where the raw data 3 would come from? 4 MR. GOLDMAN: 5 MR. GOLDMAN: Object [to the/to tell] 6 form [what/when a] do you mean [buy/by] raw data. 7 ATTORNEY 1: 8 ATTORNEY 1: [I mean/I'm/I am] 9 [you had/you'd] a collection of data at {AOE} lie 10 Lilly, didn't you. 11 A. Yes. 12 Q. [And/On] [that/this a] data was 13 collected from [varies/various] 14 [clinically/clinical] trials wasn't it? 15 A. Yes. 16 Q. [And/On] do you know where the 17 data came from when [you would/you'd] run an 18 analysis in preparation for this 19 [except/September], ['91/91/ninety-one] committee 20 meeting, do you know where the data came from? 21 When I say raw data, [I mean/I'm/I am] which 22 [clinically/clinical] trials? 23 A. Yes [in/inch/I know/I knew] 24 which {KHRAOEUPBL} trials. Page 29 1 Q. Okay. which [ones/once]? 2 A. [Well/Well,] I don't know 3 [off/often] the top of my head. 4 Q. But [that's/that he's/that is] 5 something that you could look up in a document 6 somewhere? 7 A. Yes. 8 Q. By the way, have you ever 9 [scene/seen] [clinically/clinical] trials or 10 projects [defines/defined] [buy/by] [4/four] 11 letters, [usual/usually] beginning with h? 12 A. Yes. 13 Q. [What's/What is] 14 [actual/actually] being designated [buy/by] those 15 {46R} letters? 16 A. It uniquely identification 17 [a/an] [clinically/clinical] trial. 18 Q. [What/When a] do the letters 19 [mean/me know]? 20 A. I don't know. 21 Q. As a result of the 22 [questions/question is] which were answered in 23 preparation [forth/for the/fourth] [19/nineteen], 24 ['91/91/ninety-one] advisory committee meeting, Page 30 1 did anybody at {AOE} lie Lilly [ever/every] put 2 together a manuscript? 3 MR. GOLDMAN: 4 MR. GOLDMAN: [I object/I be] 5 [to the/to tell] form, [what/when a] {TKAOUPL} 6 [buy/by] manuscript. 7 ATTORNEY 1: [I mean/I'm/I am] a draft 8 copy of an article which would 9 [then/they knew/they know] be submitted to a 10 medical journal. 11 A. [What's/What is] the question 12 again I'm sorry. 13 Q. As a result of all the 14 [questions/question is] [that/this a] were 15 answered in preparation [forth/for the/fourth] 16 FDA advisory committee meeting of [9/nine], '91, 17 did anybody [ever/every] take all the answer 18 [to the/to tell] [questions/question is] [and/on] 19 put together a manuscript? 20 A. Yes. 21 Q. [Anger/Angry] who did 22 [that/this a]? 23 A. . 24 A. [There is/There's/Theirs] more Page 31 1 than one manuscript. 2 Q. History than one manuscript 3 came out of [that/this a] what would you call 4 [that/this a] a study, eviction, I don't want to 5 use an incorrect term [hear/here]? 6 A. I don't have a better term. 7 Q. Okay. . As far as you know, how 8 many man {SKREUPTS} were developed from 9 [that/this a] information that was gathered 10 during the preparation for the advisory committee 11 meeting? 12 A. About [5/five]. 13 Q. Were you listed {AGS} 14 [had/dollars] as an author [and/on] any of these 15 manuscript? 16 A. Yes. 17 Q. How many? 18 A. [3/three]. 19 Q. Do you recall the subject area 20 [that/this a] those [3/three] man {SKREUPTS} 21 {KOFRBD}? 22 A. Yes. 23 Q. Can could you please tell me 24 that [what/when a] they were? Page 32 1 A. One manuscript was subject 2 material was suicidality [and/on] Fluoxetine 3 continue compared with placebo on try 01 click 4 {AEPBTS} depress {SAPBTS} in [u.s./u.s.] 5 [double/did you believe] blind 6 [clinically/clinical] trials. The second 7 manuscript was the same topic, [whoever/however] 8 in [clinically/clinical] trials outside the {AOU} 9 night the [state's/states]. The third manuscript 10 looked at the same topic with all trials, 11 [u.s./u.s.] [and/on] outside the [u.s./u.s.] 12 [and/on] all indications. The previous [2/two] 13 were depression trials. 14 Q. Were any of these man 15 {SKREUPTS} evently published? 16 A. Yes. 17 Q. Where was the third one you 18 described published? 19 A. [That/This a] one has not been 20 published yet. 21 Q. Are [their/there/they're] plans 22 for it to be published? 23 A. Yes. 24 Q. [Down/Do you know] when it Page 33 1 would be published? 2 A. No, I don't. 3 Q. [Down/Do you know] in 4 [what/when a] journal [it will/it'll] be 5 published? 6 A. I don't recall. 7 Q. [What/When a] about the second 8 one you described, the suicidality issue outside 9 the [u.s./u.s.]? 10 A. [What's/What is] the question. 11 Q. Has [that will/that'll] second 12 manuscript been published? 13 A. No it hadn't. 14 Q. Are [their/there/they're] any 15 plans to have it published? 16 A. Yes. 17 Q. Do you know where it would be 18 published? 19 A. I don't recall [that/this a] 20 either. 21 Q. [Down/Do you know] when 22 [it will/it'll] be published? 23 A. No, I don't. 24 Q. Have either of these [2/two] Page 34 1 man description been [accepted/excepted] to be 2 published? 3 A. {EUPBLG} pretty sure, yes. 4 Q. [Boat/Both] of [them/they mean] 5 or just one? 6 A. [Had/Dollars] third. 7 Q. The third one has been 8 [accepted/excepted] as far as you know? 9 A. [I mean/I'm/I am] pretty sure. 10 Q. Are the authors of these 11 [3/three] man description consistent? 12 A. Are they all the same for all 13 [3/three] man description. 14 A. No. 15 Q. [Who's/Whose/Who is] the author 16 of the third manuscript or authors, is 17 [doctor/Dr./Doctor,/Doctor] Beasley an author? 18 A. {TKPWAEUR} I Tolivson, Charles 19 Beasley, {PWEPB} ram {PEU}, {TKAOUG/TPEUR} 20 [ease/east], there are [mother/more], I can't 21 recall. 22 Q. [Down/Do you know] the authors 23 of the second manuscript which you described? 24 A. Yes. Page 35 1 Q. [Could you tell/Caught] me who 2 they were? 3 A. Charles Beasley, 4 [dug/did you go] {PHAEUR/RAOES}, [and/on] 5 myself. 6 Q. Do you receive any re{PHAOUPB} 7 {RAEUGS} from {AOE} lie Lilly 8 [fur/if you are/if your/if you're] listed as an 9 author [on/and] these published articles? 10 A. [What/When a] do you mean. 11 Q. Do you receive a bonus? 12 A. No. 13 Q. Do you receive any kinds of 14 notice or award or anything? 15 A. No. 16 Q. Do you receive any payment from 17 the medical {SKWRURPBLS}? 18 A. No. 19 Q. Was {TKPWR/TOL} son involved 20 in the [first/1st] [2/two] man description? 21 MR. GOLDMAN: 22 MR. GOLDMAN: When I say involved you 23 mean was he an author. 24 Q. Yes [I will/I'll/ill] ask Page 36 1 [that/this a] was he an author? 2 A. . 3 A. He was not an author {OBT} on 4 the are {TPHEURS} manuscript, [I mean/I'm/I am] 5 almost sure. He may have been an author on the 6 second. 7 Q. Was the manuscript 8 [forth/for the/fourth] [first/1st] I'm sorry, I 9 withdraw [that/this a]? 10 Q. Regarding the [first/1st] 11 manuscript where [doctor/Dr./Doctor,/Doctor] 12 {TOL} son was not an author, was [that/this a] 13 manuscript shown to [doctor/Dr./Doctor,/Doctor] 14 {TOL} son prior to publication? 15 MR. GOLDMAN: {SKWR} let me object 16 [to the/to tell] form, the question is over broad 17 was it shown to him prior to publication [buy/by] 18 who. 19 Q. Was the [first/1st] manuscript 20 published? 21 A. Yes. 22 Q. Was it published in the British 23 medical journal? 24 A. Yes. Page 37 1 Q. In [except/September] of '91? 2 A. I don't recall the 3 [date/day the]. 4 Q. Okay. was [that/this a] 5 manuscript shown to do {TOL} son prior to the 6 manuscript being [cents/sent] [to the/to tell] 7 bring the {EURB} medical journal? 8 MR. GOLDMAN: 9 MR. GOLDMAN: Same 10 [objection/ox/oxygen] shown [buy/by] whom to 11 [doctor/Dr./Doctor,/Doctor] {TOL} son. 12 Q. Shown [bite/buy the/by the] 13 {AU/THORGS} to [doctor/Dr./Doctor,/Doctor] 14 {TOL} son? 15 A. I don't know. 16 Q. Can you describe to my 17 [what/when a] a p value is? 18 MR. GOLDMAN: 19 MR. GOLDMAN: Let me just 20 [in/inch/I know/I knew] [what/when a] 21 [you are/you're/your] trying to do but let me 22 object [to the/to tell] form she can 23 [probable/probably] give a seminar [and/on] 24 [that/this a] [and/on] thus the question is over Page 38 1 broad but if she can describe is it in 2 [generally/general] terms. 3 Q. [I mean/I'm/I am] going to ask 4 you for some definition because some of the 5 [questions/question is] over the [course/coarse] 6 of the deposition might use these words or some 7 of [you are/you're/your] answer might use these 8 words [so/sew] [I mean/I'm/I am] just trying to 9 make sure sure [that/this a] [we are/we're] on 10 the same [waive/wave] [length/lent] [and/on] to 11 be [on/and] the same [waive/wave] {HREUPB}, 12 [you have/you've] to realize that I haven't 13 [had/dollars] [you are/you're/your] training 14 [and/on] {PWHABG} grounds [so/sew] 15 [what I mean/what I'm/what I am] really asking 16 for is [you know/you knew/you know,] [a/an] 17 [generally/general] description of [what/when a] 18 these are terms might [mean/me know]. I don't 19 want you to go into any detail but just [a/an] 20 [generally/general] backgrounds definition. 21 [Is that/Is this a] [objecting/okay]? 22 A. [I can/I could] try. 23 Q. Okay. . Let's start with the p 24 value? Page 39 1 A. {SEUFRPBLGTS} an is it a 2 [is/\S] {TEUS} calendar test, you start with 3 [a/an] [high/hi] pot thinks and the the p value 4 is the probability of rejecting [that/this a] 5 [high/hi] pot thinks if it was true. 6 Q. In other words does it 7 [mean/me know] [that/this a] the [high/hi] pot 8 thinks would be rejected [buy/by] chance? 9 A. Right. 10 Q. ? 11 A. . 12 Q. [What's/What is] the variance 13 estimate or? 14 A. Variance, a variance is a 15 measure of how [what/when a] kind of range 16 [you have/you've] in a particular measure. If 17 {AL} particular measure is always the same valor 18 around the same value, {AEUTS} small variance. 19 If the measure has a wide range [and/on] you see 20 a wide range of answer [you would/you'd] have a 21 large variance. 22 Q. Confidence interval? 23 A. A confidence interval subpoena 24 [usual/usually] associated with a percentage. Page 40 1 For example a ninety-five percent confidence 2 interval [and/on] loosely [that/this a] can be 3 described as [you are/you're/your] ninety-five 4 percent sure [that/this a] [you are/you're/your] 5 confidence interval would {SROUPBDZ} the true 6 {STEUPLTD}. 7 Q. [What/When a] about a nil 8 [high/hi] pot thinks? 9 A. In most studies, you start with 10 [a/an] [high/hi] pot {SEUS} 11 [that's/that he's/that is] referred to as [a/an] 12 {TPHUL} [high/hi] pot {SEUS} [and/on] 13 [that is/that's] you assume [that/this a] 14 [there is/there's/theirs] [know/no] difference in 15 our case [usual/usually] [it's/its] between 16 treatment, you assume [you are/you're/your] 17 {TPHUL} [high/hi] pot {SEUS} 18 [there is/there's/theirs] [know/no] different 19 between treatments. 20 Q. [What's/What is] the {TPHUL} 21 [high/hi] pot {SEUS} called at the I understand 22 of the study once [it's/its] proven to be true? 23 A. [A/An] {TPHUL} [high/hi] pot 24 {SEUS} is never proven to be true. It still, the Page 41 1 the {TPHUL} [high/hi] pot {SEUS} 2 [forth/for the/fourth] study, I don't think it 3 changes names. 4 Q. Well, before the study, 5 [it's/its] [a/an] [high/hi] pot {SEUS}, 6 [right/write]? 7 A. Right . 8 Q. [And/On] does it always stay 9 [a/an] [high/hi] pot {SEUS} even if [it's/its] 10 supported [buy/by] is it a {TEUS} calendar 11 [evidence/evident]? 12 A. If [it's/its] supported if 13 [there is/there's/theirs] support to eject the 14 {TPHUL} [high/hi] pot {SEUS} or not to {AOE} 15 {SKWROEBGT}, [you would/you'd] 16 [then/they knew/they know] have an inference. 17 Q. How about test is it a {TEUS} 18 sticks? 19 A. The test is it a {TEUS} stick 20 is, depending [on/and] [what/when a] analysis 21 your [doing/dog], [you would/you'd] have 22 different test is it a {TEUS} sticks based 23 [on/and] the distribution of 24 [you are/you're/your] data. [So/Sew] [it's/its] Page 42 1 related to [what/when a] analysis, [what/when a] 2 particular is it a {TEUS} calendar test your 3 using for [that/this a] analysis. 4 Q. You mean you can analyze these 5 sticks using different tests [is that/is this a] 6 [what/when a] you mean? 7 A. In {PHOEUS} cases, based 8 [on/and] literature [and/on] research, 9 [their/there/they're] would be there would be few 10 that would be appropriate. 11 Q. Okay. . Now does [that/this a] 12 relate to the distribution of data? 13 MR. GOLDMAN: 14 MR. GOLDMAN: How does [what/when a] 15 relate. 16 Q. You said the test stick, I 17 thought you said [that/this a] it would change 18 because of distribution of data would change 19 depending [on/and] [what/when a] test you used? 20 A. Right. 21 Q. Let me ask you this:, 22 [what/when a] are some of the different tests 23 [that/this a] you would use? 24 A. [There is/There's/Theirs] Page 43 1 [a/an] {KAOEU} square test {KR} had I is request 2 you an are he. [And/On] [that/this a] test is 3 [usual/usually] used when you test for 4 differences in {PROE/PORS} [is/\S]. 5 Q. [And/On] within 6 [you are/you're/your] studies with Prozac, did 7 you {AOS} the {KAOEU} scare test? 8 A. Yes. 9 Q. How about the breast low day 10 test? 11 A. Yes. 12 Q. [House/How's/How is] 13 [that/this a] different than [tell us/the] 14 {KAOEU} square? 15 A. If I remember [right/write], 16 the breast low day test is a specific {KAOEU} 17 scare test, [it's/it is/its] based [on/and] 18 {KAOEU} spare distribution. 19 A. It tests for something 20 [mother/more], something very specific, I {KAOEU} 21 square test is a [generally/general] test 22 [that can/that being] used to test a wide range 23 of proportions or whatever but the breast low day 24 test is very specific. Page 44 1 Q. Now when you used term 2 distribution of data, does [that/this a] 3 [refer/referrer] to the [way/weigh], the 4 [numbers/numbs] are placed in presentation in 5 other words does it determine the type of graph 6 [that is/that's] used or the type of table 7 [that is/that's] used to show the [numbers/numbs] 8 and the results? 9 A. Yes, depending [on/and] the 10 type of data [you are/you're/your] collecting 11 would determine how you [may/May] display the 12 data if [that's/that he's/that is] [what/when a] 13 [you are/you're/your] asking. 14 Q. Any other test that you used 15 [along/a long] these lines {KAOEU} square, breast 16 low day within the Prozac area? 17 A. We used analysis of variance . 18 Q. [House/How's/How is] 19 [that/this a] different than the {KAOEU} square? 20 A. Analysis of variance is 21 [usual/usually] used when [you have/you've] a 22 measure {THAPS} continuous. 23 A. For example come pairing 24 [mean/me know] changes in a score. [It's/Its] Page 45 1 [know/no] longer testing proportions, [it's/its] 2 testing a continuous {SRAEUR/ABL}. 3 Q. Any other tests? 4 A. Yes. 5 Q. How many [mother/more] are 6 [their/there/they're]? 7 A. [I mean/I'm/I am] not sure, a 8 few [mother/more]. 9 Q. Are [their/there/they're] any 10 others which you used broadly in the [past/pass] 11 {46R} years in regard to Prozac? 12 MR. GOLDMAN: 13 MR. GOLDMAN: [I object/I be] 14 [to the/to tell] form [what/when a] do you mean 15 [buy/by] used broadly. 16 Q. Which you used [off/often], 17 more often than others? 18 A. The man tell {HAPB} [sell/cell] 19 incidents difference [medical/med] {THOD} . 20 Q. {KOBG/RAPBS} test, dear is he 21 moan I [and/on] {HRAOERD} ? 22 Q. Many can you tell me about the 23 man tell {HAPB} [sell/cell] test? 24 A. [It's/Its] [attest/a test] Page 46 1 appropriate for testing differences in 2 proportions. [It's/Its] different from the 3 {KAOEU} square test in [that/this a] it allows 4 you to have ask a {STRAT} indication {SRAEUR} 5 {ABL}. 6 Q. Does that mean you can compare 7 in the Prozac area, would that mean you could 8 compare different [clinically/clinical] trials 9 [wherein/where in] different [numbers/numbs] of 10 [patience/patients/patient's/patient] or subjects 11 were used for instance one [clinically/clinical] 12 trial may have had [10/ten] parents, another 13 [clinically/clinical] trial may have had four 14 hundred [patience/patients/patient's/patient], 15 but with the man tell {HAPB} [sell/cell] test, 16 you could compare the [2/two] trials? 17 A. Yes you could compare the 18 treatment differences between the [2/two] trials. 19 It {KOUPBTSZ}, the {KAOEU} square test would just 20 take the difference in proportions across all 21 trials in [you are/you're/your] example, the man 22 tell {HAPB} [sell/cell] test would take {AL} 23 [waited/weighted] average of each difference 24 within each trial. Page 47 1 A. [It's/Its] a different approach 2 [that will/that'll] to take into account 3 differences you [may/May] see between trials. 4 Q. Okay. . 5 Q. Anytime you want to take [a/an] 6 [brake/break] just let [mean/me know], 7 [objecting/okay]? 8 A. (Witness moves head up and 9 down.). 10 Q. Is it part of the statisticians 11 function to design the to help in design the 12 [clinically/clinical] trial? 13 A. Yes. 14 Q. Now, when [a/an] 15 [clinically/clinical] trial is planned, is one of 16 the [first/1st] [things/thinks] to be discussed 17 is the [high/hi] pot {SEUS} that would be will 18 investigated? 19 A. I deally, yes. 20 Q. [So/Sew] that would be the 21 {TPHUL} [high/hi] pot {SEUS}, [right/write]? 22 A. [And/On] the alternative 23 [high/hi] pot {SEUS}. 24 Q. [So/Sew] if you were going to Page 48 1 take a collection of many [clinically/clinical] 2 trials [and/on] pool the is it a {TEUS} sticks, 3 would [it be/it been] important [that/this a] 4 each of those [clinically/clinical] trials had 5 the same [high/hi] pot {SEUS} to start with? 6 A. {THAEPS} [probable/probably] a 7 debatable question. 8 Q. Well, [what/when a] do you 9 think? 10 A. It depends [on/and] the this 11 particular objective of why you want to put the 12 studies together. 13 Q. [Well/Well,] now 14 [doesn't/don't] [clinically/clinical] trials have 15 objectives within the [clinically/clinical] 16 trial? 17 A. Yes. 18 Q. [And/On] [so/sew] the question 19 would be the same as it was 20 [forth/for the/fourth] [high/hi] pot {SEUS}, if 21 you were going to pool many different 22 [clinically/clinical] trials for the data 23 contained in {THOEPS} [clinically/clinical] 24 trials, wouldn't [it be/it been] important Page 49 1 [forth/for the/fourth] {KHRAOEUPBL} trials to 2 have the same objectives? 3 A. Not necessarily. 4 Q. In other words in your opinion, 5 you can superseded {OFBSZ} of the 6 [clinically/clinical] trial with [a/an] overall 7 objective where [you are/you're/your] going to 8 pool all the [clinically/clinical] trials for 9 [their/there/they're] data? 10 MR. GOLDMAN: 11 MR. GOLDMAN: Before she answer let me 12 object [to the/to tell] form because 13 [she is not/she's not] testified anything about 14 {SAOUP/SAOED} [go/\ing] objectives, 15 [she is/she's/she say] simply has told you in her 16 opinion, it's not necessarily the case [so/sew] 17 you [miss/Ms./Miss] character [rise/rice] 18 [had/dollars] her prior testimony. 19 Q. Did you understand the 20 question? 21 A. No or did you forget it. 22 A. I forgot {STKPWHRAOEUFRPBLGTS}. 23 (THE COURT REPORTER READ BACK THE 24 REQUESTED TESTIMONY.) Page 50 1 {STKPWHRAOEUFRPBLGTSDZ} 2 ATTORNEY 1: 3 ATTORNEY 1: Do you want me rephrase. 4 A. Yes. 5 Q. Okay. . If 6 [you are/you're/your] going to pool the data from 7 many [clinically/clinical] trials [and/on] 8 analyze the data, with [a/an] objective in mind, 9 are you saying [that/this a] the individual 10 [clinically/clinical] trials objectives do not 11 have to be the same in order to accomplish 12 [that/this a] task? 13 A. [That's/That he's/That is] 14 true. 15 Q. {ORBG}. 16 Q. Prior to [we are/we're] still 17 talk [go/\ing] about the design of the 18 [clinically/clinical] trial, [ones/once] the 19 trial is designed, is it important to perform 20 pilot trials? 21 A. Can repeat the question. 22 Q. Is it important to perform 23 pilot trials in the [course/coarse] of designing 24 the [clinically/clinical] trial? Page 51 1 MR. GOLDMAN: 2 MR. GOLDMAN: [I object/I be] 3 [to the/to tell] form, I don't know [that/this a] 4 anybody [defines/defined] a pilot trial yet. 5 Q. Have you ever had heard the 6 term pie lot trial? 7 A. Yes. 8 Q. [What's/What is] does it 9 [mean/me know] to you? 10 A. Is is. 11 A. The objective of a pilot trial, 12 [I would/I'd] think is not necessarily looking 13 for a treatment difference or any 14 [clinically/clinical] difference, it would be 15 [mother/more] just to tryout for example a 16 particular [knew/new] scale or to just to test a 17 particular [knew/new] idea I would say. 18 Q. Would [it be/it been] to make 19 sure [that/this a] the [clinically/clinical] 20 trial would run smoothly, isn't it kind of like 21 [attest/a test] run [forth/for the/fourth] 22 [clinically/clinical] trial or [attest/a test] 23 run for a portion of the [clinically/clinical] 24 trial? Page 52 1 A. The [way/weigh] 2 [I mean/I'm/I am] thinking of a pilot trial, it 3 would be done before, it would not be done in con 4 junk with another trial, it would be done before 5 a trial is start [today//ed to] learn something 6 of interest. 7 Q. For [that/this a] article that 8 you {SKWUS} [had/dollars] that was published in 9 the British medical journal, were any 10 {KHRAOEUPBL} trials performed for [that/this a] 11 article, form specifically for [that/this a] 12 article? 13 A. Were were they performed 14 because of [that/this a] article. 15 Q. ? 16 Q. [Know/No] 17 [forth/for the/fourth] article {ORB} 18 [is that/is this a] a situation where the results 19 of many [clinically/clinical] trials were pooled? 20 A. The results of many 21 [clinically/clinical] trials were pooled. 22 Q. [Down/Do you know] how many 23 [clinically/clinical] trials were pooled? 24 A. Yes. Page 53 1 Q. How many? 2 A. [I mean/I'm/I am] pretty sure 3 [17/seventeen] [forth/for the/fourth] united, 4 [forth/for the/fourth] [u.s./u.s.], manuscript. 5 Q. Did all [17/seventeen] of 6 {THOEPS} [clinically/clinical] trials have the 7 same objectives? 8 A. No. 9 Q. ? 10 A. Not identical objectives. 11 Q. When you pooled {AUPLT} 12 [clinically/clinical] trials, did 13 [you have/you've] a sing {TKPWHRAR} objective at 14 [that/this a] point? 15 A. No. 16 Q. Did you have a critical 17 objective? 18 A. Yes. 19 Q. What was the critical 20 objective? 21 A. To compare the incidents of 22 suicidality between treatment [groupings/groups]. 23 Q. Were any of the [17/seventeen] 24 [clinically/clinical] {TRAOEUFRLS/KWERPBDZ} Page 54 1 with suicidality of the treatment group? 2 MR. GOLDMAN: 3 MR. GOLDMAN: Before {AOE} answer let 4 me object [to the/to tell] form, you used the 5 term knowledge concerned with suicidality as 6 being vague [am/a.m.] big [us/you say] otherwise 7 undefined. 8 Q. Of the [17/seventeen] trials 9 which were pooled, did any of [them/they mean] 10 have [a/an] objective which mentioned suicidality 11 or [a/an] objective which was [wherein/where in] 12 suicidality was a part of the subject? 13 A. [I would/I'd] think all of 14 those [clinically/clinical] trials had comparing 15 event rates adverse event rates between 16 treatments in which suicide would be part of 17 [that/this a] {STKPHRAO} but were those 18 [clinically/clinical] trials performed to study 19 suicidality. 20 A. Not [that/this a] 21 [I mean/I'm/I am] aware of. 22 Q. But the pooled 23 [information/infers] from those 24 [clinically/clinical] trials was Page 55 1 [forth/for the/fourth] purpose of studying 2 suicidality? 3 A. Right . 4 Q. Why was it a critical objective 5 of [that/this a] particular study to compare the 6 incidents of suicidality with Fluoxetine 7 continue? 8 MR. GOLDMAN: 9 MR. GOLDMAN: When you say 10 [that/this a] study, you mean the pooled data 11 analysis. 12 Q. Yes the [you would/you'd] 13 pooled data analysis, the study 14 [we have been/we've been] talking about? 15 A. [What's/What is] the question 16 again. 17 Q. Stated [and/on] 18 [weak/week/we can] read it back I didn't have a 19 chance to [right/write] [down/do you know] the 20 complete word {LG} of [what/when a] the critical 21 objective was, I think you said it was to compare 22 the incidents of suicidality [and/on] Fluoxetine 23 continue [and/on] placebo? 24 A. Yes. Page 56 1 Q. [And/On] try sick {KHREUBGS}? 2 A. Yes. 3 Q. Why was [that/this a] a 4 critical objective? 5 A. That was the question 6 [that/this a] we were trying to address. 7 Q. Okay. do you know why you were 8 attempting to address [that/this a] question? 9 A. Yes. 10 Q. Why? 11 A. [Their/There/They're] was a 12 publication [that/this a] [raced/raised] the 13 concern [that/this a] Fluoxetine continue 14 [may/May] cause suicidality in some 15 [patience/patients/patient's/patient] [and/on] 16 [so/sew] we [so/sew] we addressed [that/this a] 17 [buy/by] look {LG} into our {KHRAOEUPBL} trial 18 data base. 19 Q. Okay. . Now, is it important 20 [that/this a] the objectives of the 21 [clinically/clinical] trial be stated in a manner 22 where they lack [am/a.m.] big {KWRUS} terms? 23 A. In most cases, yes. 24 Q. Wouldn't [that/this a] really Page 57 1 [affect/effect] the is it a {TEUS/SKAL} valid 2 if the objectives were stated in [am/a.m.] big 3 {KWRUS} terms? 4 A. . 5 A. Not necessarily. 6 Q. Well, can you describe when 7 [a/an] [am/a.m.] big {KWRUS}ly stated objective 8 would not [affects/effects] the is it a {TEUS} 9 {SKAL} validity? 10 A. . 11 A. It's not [unusually/unusual] to 12 have [a/an] objective [that/this a] [lacks/lax] 13 [that/this a] has all the detail [that/this a] 14 [you would/you'd] need to [actual/actually] run 15 through the analysis [so/sew] it's not [and/on] I 16 would say if you did have [a/an] objective 17 [that/this a] {HRABLG} [had/dollars] all the 18 [necessary/\NESS] detail, it still would not 19 imply the is it a {TEUS/SKAL} test is invalid 20 but ideal I yes [you would/you'd] want 21 [you are/you're/your] objective to be stated as 22 [close/clothes] as possible [and/on] in as much 23 detail as possible {SOEU} [that/this a] 24 [that's/that he's/that is] not the case. Page 58 1 Q. But if the objective was stated 2 in [am/a.m.] big {KWRUS} terms, [doesn't/don't] 3 that mean [that/this a] the variance of interpret 4 {TAEUGS} of the is it a {TEUS} calendar 5 [figures/physician] would be greater to cover the 6 [am/a.m.] by {TKPWAOUT}? 7 A. . 8 A. Are you referring to a study 9 [that's/that he's/that is] being designed or a 10 study. 11 Q. [I mean/I'm/I am] saying in 12 [generally/general], in [generally/general] isn't 13 it [a/an] [mother/more] correct procedure to have 14 [a/an] objective [that's/that he's/that is] not 15 {ABG} big {KWRUS}? 16 A. Yes. 17 Q. [And/On] isn't it [mother/more] 18 many correct procedure to have a critical 19 objective [that/this a] does not contain 20 [am/a.m.] big {KWRUS} terms {SEUFRPBLGTS} that 21 would be {PRAOEFRDZ}? 22 Q. When you pooled the various 23 [clinically/clinical] trials [and/on] 24 [you had/you'd] the critical objective, did Page 59 1 [you have/you've] any other objectives for 2 [that/this a] study? 3 A. Wheadon a number of objectives, 4 yes. 5 Q. Do you recall [what/when a] the 6 others were? 7 A. [Well/Well,] most of our 8 objectives were looking at different aspects of 9 suicidality. We wanted to look at suicidality to 10 finds just whether or not suicidality occurred 11 based [on/and] a very strict definition. We 12 looked at suicidality as emergence of suicidality 13 which means the patient was not suicidal to start 14 with but [then/they knew/they know] during the 15 [course/coarse] of the study became suicidal 16 [and/on] we defined [that/this a] very 17 thoroughly, we looked at whether or not 18 suicidality improved from the start of study 19 [to the/to tell] end of study whether or not it 20 [worse/worst] end in [any way/anyway] from the 21 start [to the/to tell] end [ever/every] study, 22 [so/sew] most of the objectives were related to 23 suicidality but just were [mother/more] specific 24 [and/on] part of [that/this a] we did look at Page 60 1 whether or not [what/when a] kinds of base line 2 {SRAEUR/RABLS} [may/May] [affect/effect] some 3 of the results or whether or not {AP} patient had 4 suicidality which was not in the paper but 5 Wheadon a number of other objectives was part of 6 [that/this a] [hole/whole] analysis. 7 Q. Okay. . The validity of the 8 pooled [clinically/clinical] trials, 9 [is that/is this a] depend dented on the validity 10 of the individual [clinically/clinical] trials? 11 A. [What/When a] do you mean 12 [buy/by] have lid {TEU}. 13 Q. [I mean/I'm/I am] the 14 confidence {EUPBTSDZ} value [may be/maybe], in 15 other words [that's/that he's/that is] 16 [probable/probably] not the [right/write] 17 [way/weigh] to use confidence interval but the 18 the the accuracy? 19 A. . 20 Q. Of the pool 21 [clinically/clinical] trials, aren't they depend 22 {TKEPBTSD} on the efficiency [and/on] profession 23 {HREUFPL} with which the individual 24 [clinically/clinical] trials were done? Page 61 1 A. Yes. 2 Q. [So/Sew] when the wouldn't 3 [it be/it been] important [that/this a] all the 4 {-P} [clinically/clinical] trials [that/this a] 5 were pooled be checked as to 6 [their/there/they're] integrity? 7 MR. GOLDMAN: 8 MR. GOLDMAN: [I object/I be] 9 [to the/to tell] form [and/on] the vagueness of 10 the term integrity, integrity of [what/when a]. 11 Q. [Well/Well,] [let's/lets] take 12 for example blinds, the use of blinds. Did all 13 the [clinically/clinical] trials which were 14 pooled use blinds? 15 A. They were all 16 [double/did you believe] blind studies. 17 Q. Were [their/there/they're] any 18 trip pal blinds studies? 19 A. When you say trip pal lined 20 [what/when a] do you mean. 21 Q. [I mean/I'm/I am] [that/this a] 22 even the investigators don't know 23 [what's/what is] being given out? 24 A. The investigator does not know Page 62 1 [what's/what is] given {OURT} in [a/an] {PWUBL} 2 blind study {STKPWHRAOEU} [so/sew] even the 3 person at {AOE} lie Lilly [who's/whose/who is] 4 cents [go/\ing] the [samples/samples] 5 [to the/to tell] investigator would not know 6 which was the placebo [and/on] which was Prozac. 7 A. I need [a/an] 8 [did he have/definite/deaf] {TKPHEUGS} of 9 [what/when a] you think of 10 [double/did you believe] {PWHRAOEUPBTD} [and/on] 11 trip blind. 12 Q. [A/An] [double/did you believe] 13 lined blinds study is as you said the 14 investigator is giving out a drug and the {SREG} 15 {TOR} don't know if [it's/its] a placebo or in 16 this case Prozac is that correct? 17 A. Uh-huh. 18 MR. GOLDMAN: 19 MR. GOLDMAN: Yes. 20 A. Yes. 21 Q. [And/On] [a/an] [triple/trim] 22 blind study would [mean/me know] [that/this a] 23 when the person at {AOE} lie Lilly sent the 24 {PHRA/SAOEB} boast of Prozac [to the/to tell] Page 63 1 investigator, the person at {AOE} lie Lilly 2 didn't {TPHOEU} which was the Prozac [and/on] 3 which was the placebo either? 4 A. . 5 Q. That would be [a/an] 6 [triple/trim] blind? 7 A. With [that/this a] definition 8 [I would/I'd] think [that/this a] [may be/maybe] 9 impossible for [a/an] [triple/trim] blind study, 10 I think somebody has [to know/ton] 11 [what's/what is] going into the kits [and/on] 12 even in [a/an] {PWUBL} blind study, we {KEP} 13 [that/this a] as a very minimal for Lilly 14 [personal/personnel/personally]. 15 Q. Do you [actual/actually] have 16 anything to do with designing oral figuring out 17 the [way/weigh] [that/this a] the drugs are 18 distributed? 19 MR. GOLDMAN: 20 MR. GOLDMAN: You as in her. 21 Q. Yes you, [miss/Ms./Miss] sale 22 [err//er]? 23 A. How the drug is distributed. 24 Q. Yes. In other words the Page 64 1 [way/weigh] the employee would package the drugs 2 or label the drugs before mailing 3 [them/they mean] to the [clinically/clinical] 4 investigate {TOR}? 5 A. I have not. 6 Q. Have you ever 7 [is that/is this a] part of the stat I say 8 {STEUGS} [is/\S] job? 9 A. They might, a stat I say 10 {STEUGS} may have some involvement in 11 [that/this a] if [there is/there's/theirs] 12 something [that's/that he's/that is] different 13 been the study, [that/this a] [may/May] need 14 special care or if [their/there/they're] trying 15 something different [that's/that he's/that is] 16 hadn't been done in the [past/pass], a stat I say 17 {STEUGS} [may be/maybe] involved. 18 Q. Did {AOE} lie Lilly have away 19 of making sure [that/this a] the 20 [double/did you believe] blind studies were 21 protected. 22 Q. {*F}? When I say 23 [double/did you believe] blind studies being 24 protected [that/this a] the blind were being Page 65 1 protected? 2 A. . 3 MR. GOLDMAN: {SKWR/RET} let {PHE} 4 object [to the/to tell] form when you say 5 protected from whom the investigator and the 6 patient. 7 ATTORNEY 1: Yes. 8 MR. GOLDMAN: {SKWRAOT/PEURPBTSZ} who 9 were [pose/post] supposed to be {PWHRAOEUTD} 10 [had/dollars] I. 11 ATTORNEY 1: 12 ATTORNEY 1: Yes. 13 A. Yes. 14 Q. [How would/How old] they do 15 [that/this a]? 16 A. The cap {SAOULS} would look 17 identical, the {PWOTD} link would look identical 18 or the kits. 19 Q. [Well/Well,] [what/when a] 20 about [in a/in an] a situation where {AL} 21 investigator [cease/sees/seize] a reaction in a 22 patient [and/on] now becomes aware [that/this a] 23 the drug is either {PHRA/SAOEB/PWOE} or 24 Prozac [actual/actually] it he becomes aware Page 66 1 [that/this a] [it's/its] [proceeds/procedures], 2 this is [a/an] {HAOEUP} they had calendar, 3 [and/on] now the investigator 4 [knows/nose/no, sir] [what/when a] he or she is 5 giving [to the/to tell] subject, does {AOE} lie 6 Lilly have away of protecting [that/this a] from 7 occurring? 8 MR. GOLDMAN: 9 MR. GOLDMAN: Let let me object 10 [to the/to tell] form because your question 11 assumes [that/this a] it has happened, 12 [that/this a] the blind has been broken [and/on] 13 [then/they knew/they know] [you are/you're/your] 14 asking to do [they've/they have] away to prevent 15 it from not happening. 16 ATTORNEY 1: [It's/Its] [a/an] 17 [high/hi] they the {KL} [I mean/I'm/I am] not 18 stating it [ever/every] happened, 19 [I mean/I'm/I am] just saying if [that/this a] 20 did happen did {AOE} lie Lilly have a procedure 21 [that/this a] [they would/they'd] follow 22 {EUFRPBLT} if {AL} [figures/physician] needed 23 [to know/ton] [what/when a] the patient was 24 taking due to a serious event, yes Page 67 1 [there is/there's/theirs] a procedure 2 [that/this a] golf earns [what/when a] 3 [it's/it is] [that's/that he's/that is] supposed 4 to be done in [that/this a] case. 5 Q. [Well/Well,] was [that/this a] 6 something like that [ever/every] done in any of 7 the [17/seventeen] studies which were pooled? 8 MR. GOLDMAN: 9 MR. GOLDMAN: {OEUB} [to the/to tell] 10 form something like [what/when a]. 11 Q. Something like the procedure 12 which had to be performed in the event 13 [that/this a] [a/an] {PWHRAOEUPBTD} was broken? 14 A. . 15 MR. GOLDMAN: 16 MR. GOLDMAN: I'm sorry, [I have/I've] 17 [to the/to tell] form is the question was 18 [their/there/they're] a blind [ever/every] broken 19 in any of those [17/seventeen] studies or. 20 Q. Let me withdraw my question? 21 Q. [And/On] [I will/I'll/ill] 22 adopt [you are/you're/your] counsel question. 23 Q. As far as you know in any of 24 those [17/seventeen] studies, were any blind Page 68 1 [ever/every] broken? 2 A. In blinds [you are/you're/your] 3 referring to the investigator or patient. 4 Q. Yes? 5 A. . 6 A. [I mean/I'm/I am] pretty sure 7 [that/this a] must have had to happen. 8 Q. {TPRAOEUR} pooling the 9 [17/seventeen] studies, was 10 [therefore/there ever] an accounting made of when 11 [and/on] where [that/this a] happened? 12 A. Yes. 13 Q. [And/On] did you ever read 14 [that/this a] accounting? 15 A. No. 16 Q. You mentioned [that/this a] 17 during the time that you pooled the 18 [17/seventeen] [clinically/clinical] trials, you 19 [actual/actually] you were involved in [3/three] 20 man description [that/this a] grew out of 21 [that/this a] is that correct? 22 A. Yes. 23 Q. [Well/Well,] if you were 24 designing [a/an] [clinically/clinical] trial, Page 69 1 would you design it to study more than [1/one] 2 [high/hi] pot {SEUS}? 3 A. You can do [that/this a]. 4 Q. Is it {PHOERB} correct to have 5 as few [high/hi] pot {SEUS} as possible? 6 A. [That's/That he's/That is] 7 debatable. 8 Q. If [you had/you'd] several 9 [high/hi] pot {SEUS}, wouldn't [that/this a] 10 [affect/effect] the accuracy of the is it a 11 {TEUS} sticks which are gathered because 12 [tell us/the] researcher is [actual/actually] 13 trying to delve into more than one subjects area? 14 MR. GOLDMAN: 15 MR. GOLDMAN: Let me object to form are 16 you asking this question in the abdomen 17 {STRABGTD}. 18 ATTORNEY 1: 19 ATTORNEY 1: Yes. 20 MR. GOLDMAN: 21 MR. GOLDMAN: Not related to any 22 specific coming pounds. 23 ATTORNEY 1: 24 ATTORNEY 1: [Right/write]. Page 70 1 A. [That's/That he's/That is] 2 debatable also. 3 Q. When you say 4 [that's/that he's/that is] debatable does that 5 mean there are some stat {STEUGS} [is/\S] who 6 would take one side [that/this a] it 7 [doesn't/don't] matter how many [high/hi] pot 8 {SEUS} [you have/you've] [and/on] other stat 9 {STEUGS} [is/\S] would say [you have/you've] to 10 have as few as possible? 11 A. Yes. 12 Q. [What is your/What's your] 13 opinion? 14 A. My opinion [is that/is this a] 15 you can have many [high/hi] pot {SEUS}. 16 Q. ? 17 ATTORNEY 1: 18 ATTORNEY 1: Can we take [a/an] 19 [brake/break] {WAOUFB} going about an hour and a 20 half [she is/she's/she say] got a little 21 [cough/could have] [hear/here]. 22 ATTORNEY 1: 23 ATTORNEY 1: Sure 24 {STKPWHRAOEUFRPBLGTS}. Page 71 1 (A SHORT RECESS WAS TAKEN.) 2 {STKPWHRAOEUFRPBLGTS} with [go/\ing]. 3 ATTORNEY 1: 4 ATTORNEY 1: 5 ATTORNEY 1: 6 Q. [We are/We're] basically 7 talking about the stat {STEUGS} [is/\S] 8 [role/roll] in designing [a/an] 9 [clinically/clinical] trial, [I would/I'd] like 10 to ask you [along/a long] those lines is it 11 important in designing the trials to establish a 12 gloss {REU} or a set of phrases [that/this a] 13 would describe the results observed in each 14 {SREUFRPD} patient [so/sew] [that/this a] 15 [then/they knew/they know] the results could be 16 grouped in a manner that would have is it a 17 {TEUS/SKAL} significant? 18 A. Not necessarily. 19 Q. [Well/Well,] now, if for 20 instance [you had/you'd] [a/an] 21 [clinically/clinical] trial where one 22 [clinically/clinical] investigator was calling an 23 event attempts [had/dollars] suicide [and/on] 24 [you had/you'd] another [clinically/clinical] Page 72 1 trial [and/on] [a/an] [clinically/clinical] 2 investigator was calling an events overdose 3 [and/on] they were the same basic facts, 4 {WOPBLTS} [that/this a] cause the is it a {TEUS} 5 sticks to become somewhat irregular or? 6 A. You could always put those 7 together afterwards if you had if that was a 8 concern. 9 Q. You mean the {STPAT/STEUGS} 10 can put those together? 11 A. No, it would be the 12 [figures/physician] making the 13 [significance/decision] [on/and] how to put it 14 together [and/on] either the stat {STEUGS} 15 [is/\S] or a systems analyst would combine 16 [them/they mean] for analysis purposes. 17 Q. Okay. . But wouldn't 18 [it be/it been] better in the ideal 19 [clinically/clinical] trial to avoid 20 [that/this a] problem, [that/this a] to avoid 21 [that/this a] step [and/on] just {AOE/TPHAOUPL} 22 rate a gloss {REU} or a set of results, a cat 23 sayings of results [and/on] 24 [that's/that he's/that is] [forth/for the/fourth] Page 73 1 the [clinically/clinical] investigator to look at 2 [and/on] to fit [diagnosis/diagnosis] within the 3 events or the gloss {REU}? 4 A. {EUPLG} not sure. 5 MR. GOLDMAN: 6 MR. GOLDMAN: Before {HAOE} evens let 7 me object [to the/to tell] form [to the/to tell] 8 extent, it assumes that was not done to some 9 extent in these trials [and/on] I think the 10 [evidence/evident] from all the 11 [witness is/witnesses] so far [is that/is this a] 12 there was certain map [go/\ing] cat sayings. 13 Q. [I mean/I'm/I am] not talking 14 about any specific trial? 15 MR. GOLDMAN: 16 MR. GOLDMAN: This is notice abstract. 17 ATTORNEY 1: 18 ATTORNEY 1: 19 Q. [And/On] [I mean/I'm/I am] not 20 assuming anything was done or not done. My only 21 question to you as a stat {STEUGS} [and/on] 22 [you are/you're/your] [role/roll] of designing 23 clinical trials is is it important or does it not 24 matter to have consistent event terms Page 74 1 {SEUFRPBLGTS} I think will are advantages 2 [and/on] disadvantages if this is having 3 consistent terms [and/on] not having consist 4 {STEPBTSD} terms? 5 Q. One of the {TKEULS} advantages 6 [is/\S] is? 7 A. . 8 Q. Of having consistent terms? 9 A. Of having consistent terms. 10 A. . 11 Q. Yes? 12 A. [May be/Maybe] the investigator 13 would feel it [doesn't/don't] quite fit into any 14 of terms [that/this a] we provide 15 [them/they mean] [and/on] 16 [then/they knew/they know] that would be a 17 disadvantage if they {K-PBTS} character 18 [rise/rice] [what/when a] they feel the event is. 19 Q. Okay. [and/on] [so/sew] the 20 advantage would be the op sit of [that/this a], 21 [that/this a] the investigator could be 22 [mother/more] {PRAO} size in his 23 [diagnosis/diagnosis]? 24 A. Yes. Page 75 1 Q. But in order to pull the data, 2 isn't some [clinically/clinical] 3 [figures/physician] at {AOE} lie Lilly going 4 {TOL} change the [diagnosis/diagnosis] 5 [any way/anyway]? 6 MR. GOLDMAN: 7 MR. GOLDMAN: Let me object 8 [to the/to tell] form [to the/to tell] extent 9 [you are/you're/your] assuming 10 [there is/there's/theirs] going to be any change 11 of one [diagnosis/diagnosis] from [a/an] {SEGT} 12 {TOR} to another [figures/physician]. 13 Q. Okay. ? 14 MR. GOLDMAN: It assumes a fact 15 [that will/that'll] never be in evidence could 16 you read. 17 A. I I still [doesn't/don't] 18 understand, I don't know how to answer 19 [that/this a]. 20 Q. You said win of the advantages 21 [is/\S] to not having consist {-P/STEPBTS} 22 terms [is that/is this a] [it will/it'll] permit 23 the [clinically/clinical] investigator to be 24 [mother/more] precise in the {KHRAOEUPBL} Page 76 1 investigators mind as to applying [a/an] 2 [diagnosis/diagnosis] to a patient? 3 A. Uh-huh. 4 Q. [And/On] 5 [what I mean/what I'm/what I am] implying 6 [buy/by] my question [is that/is this a] one 7 investigator might see a set of {TPARBGTS} 8 [and/on] apply [a/an] [diagnosis/diagnosis], 9 [and/on] another [clinically/clinical] 10 [diagnosis/diagnosis] might see the same facts 11 [and/on] apply a different [diagnosis/diagnosis] 12 but with a different term [and/on] 13 [what I mean/what I'm/what I am] saying 14 [is that/is this a] if [that/this a] happens, how 15 do those [2/two] terms become combined 16 {SEUFRPBLGTSDZ} for [what/when a], {STHRL} 17 something specific? 18 Q. Yes [forth/for the/fourth] 19 purpose? 20 A. Or this this abdomen {SRABGT}. 21 Q. This is abdomen {SRABGT}, 22 [forth/for the/fourth] purpose of pooling the 23 data, for instance the [clinically/clinical] 24 investigator in one of the [17/seventeen] Page 77 1 [clinically/clinical] trials may have called a 2 certain [set/is he the] of facts an attempted 3 suicide? 4 A. Right. 5 Q. Another [clinically/clinical] 6 investigator in another [clinically/clinical] 7 trial [wife's/wives] pool may have called the 8 same [set/is he the] of facts [a/an] overdose? 9 A. Right . 10 Q. [How old/How would] those 11 eventually come together if they were in fact the 12 same [set/is he the] of facts, they should be 13 together,, [right/write]? 14 A. If [that's/that he's/that is] 15 one of the objectives is to look at [that/this a] 16 particular events,. 17 Q. Okay. . [So/sew] wouldn't 18 [it be/it been] [a/an] {KHRAOEUPBL} 19 [figures/physician] at {AOE} lie Lilly who would 20 make the determination [hey/hay/hey,] these are 21 the same, they need to be under the same name are 22 or they need to be in the same category? 23 A. [I mean/I'm/I am] not sure in 24 the [generally/general] [sense/since]. In the Page 78 1 [generally/general] since [I mean/I'm/I am] not 2 sure [what/when a] the [clinically/clinical] 3 physicians do. As far as looking at events. 4 Q. Well, do the 5 [clinically/clinical] physicians look at the 6 indication report forms? 7 A. Yes. 8 Q. Do they read about the events 9 on the case report forms? 10 A. Yes. 11 Q. Did they give [that/this a] 12 information to the systems analyst {SKWRULS} 13 exactly as [it's/its] written on the case report 14 form? 15 A. I [it's/it is/its] my 16 understanding [that/this a] the investigators at 17 the [cite/sight/site] will record the events 18 [and/on] assign it a particular term 19 [that's/that he's/that is] supposed to group 20 terms to some extent. 21 Q. Okay. ? 22 A. [And/On] [what/when a] a Lilly 23 research physician does over [and/on] beyond 24 [that/this a], [I mean/I'm/I am] not sure. Page 79 1 Q. Are you in the [course/coarse] 2 of [you are/you're/your] employment regarding 3 Prozac answer {ABL} to any [figures/physician] 4 within Lilly? 5 MR. GOLDMAN: {SKWRO} let me abdomen 6 [to the/to tell] form [what/when a] do you mean 7 [buy/by] answer {ABL} to any [figures/physician] 8 do you want [to know/ton] does she report to one 9 or are they her boss. 10 Q. Do you report to one? 11 A. No. 12 Q. ? 13 A. Report does [that/this a] imply 14 being a boss. 15 Q. [Know/No] it could also imply 16 being someone that you work with for a 17 substantial amount of time? 18 A. Do I work with a number of 19 physicians. 20 Q. Which physicians {STKWRAO}? 21 MR. GOLDMAN: When. 22 Q. Over the [past/pass] [4/four] 23 years have you worked with for a substantial 24 amount of time? Page 80 1 A. Charles Beasley, {TKPWAEUR} I 2 {TOL} son, [their/there/they're] 3 [probable/probably] the [2/two] [that/this a] 4 [I have/I've] worked with the most. 5 Q. Okay. . Now, if there are 6 advantages [is/\S] to event terms being 7 [in/inch/I know/I knew] consistent, [I would/I'd] 8 like to ask you if the event terms are 9 [in/inch/I know/I knew] consistent 10 [doesn't/don't] [that/this a] lead to a different 11 statistical analysis than if the event terms were 12 consistent? 13 MR. GOLDMAN: 14 MR. GOLDMAN: Before she answer object 15 [to the/to tell] form in [that/this a] it 16 [miss/Ms./Miss] character [rise/rice] {DZ} her 17 testimony, she didn't testify [that/this a] 18 [their/there/they're] were advantages [is/\S] to 19 [them/they mean] being [in/inch/I know/I knew] 20 consistent. 21 A. She just said 22 [their/there/they're] were advantages [is/\S] to 23 not having [a/an] {TPEUBLGS} [had/dollars] 24 [set/is he the] of the terms Page 81 1 [forth/for the/fourth] the investigator for 2 example to apply. 3 Q. Do you understand my question? 4 A. No. 5 Q. Okay. . 6 Q. If the investigate {TOR} has 7 affixed [set/is he the] of terms to apply to a 8 certain [diagnosis/diagnosis], [and/on] 9 [I mean/I'm/I am] considering [that/this a] 10 [a/an] having consistent events terms, 11 [objecting/okay], if that was done, wouldn't the 12 is it a {TEUS} calendar outcome be different than 13 if [their/there/they're] were [know/no] 14 [set/is he the] of terms [forth/for the/fourth] 15 investigate {TOR} to use, wouldn't it, the 16 [first/1st] situation be different than if the 17 [clinically/clinical] investigator was just using 18 his or her own description, words to describe 19 [a/an] [diagnosis/diagnosis]? 20 MR. GOLDMAN: 21 MR. GOLDMAN: Let me {AOB} 22 [to the/to tell] extent [it's/its] [a/an] 23 hypothetical question [I object/I be] because it 24 does not give her sufficient facts to go from a Page 82 1 consist {STEPBLGTS} or [in/inch/I know/I knew] 2 consistent [set/is he the] of {SREPBLTSD} terms 3 [to the/to tell] outcome, the question 4 [doesn't/don't] [clued/include/conclude] enough 5 facts for her to drew [that/this a] conclusion. 6 Q. ? 7 MR. GOLDMAN: 8 MR. GOLDMAN: If she can answer it, go 9 [ahead/a head]. 10 Q. Can? 11 ATTORNEY 1: 12 Q. Can you answer it? 13 A. Not [without/would you tell] a 14 lot of {TPS},. 15 Q. Why don't you try answer it 16 with [you are/you're/your] {TPS}? 17 A. . 18 Q. [I will/I'll/Ill] rephrase the 19 question? 20 A. Okay . 21 Q. In [a/an] [clinically/clinical] 22 trial I'm sorry? 23 Q. In [a/an] [clinically/clinical] 24 trial analysis where [17/seventeen] Page 83 1 [clinically/clinical] trials are pooled, isn't it 2 important [that/this a] the [17/seventeen] 3 [clinically/clinical] investigators used the same 4 event terms, a consistent [set/is he the] of 5 event terms? 6 A. Not necessarily. 7 Q. Okay. . If they used consistent 8 event terms, would the is it a {TEUS} calendar 9 outcome be different than if they used 10 [in/inch/I know/I knew] consist {STEBTS} event 11 terms? 12 A. Not necessarily. 13 Q. [House/How's/How is] 14 [that/this a] avoided in the case where 15 [in/inch/I know/I knew] consistent terms are 16 used, [house/how's/how is] the different outcomes 17 avoided from when consistent terms are used? 18 A. You can try to make the terms 19 consistent based [on/and] reading comments 20 [and/on] make [them/they mean] consist {STEPBTSD} 21 before it gets analyzed. 22 Q. [So/Sew] somebody is making 23 [them/they mean] consistent? 24 MR. GOLDMAN: {SKWR} let {AOE} object Page 84 1 [to the/to tell] form, she said 2 [that's/that he's/that is] something you could do 3 now you said somebody in fact [doing/dog] it. 4 Q. [Know/No] I'm sorry, in the 5 hypothetical [then/they knew/they know] somebody 6 would be making the [in/inch/I know/I knew] 7 consistent terms consistent in other words to 8 analyze [that/this a] is that correct? 9 A. [That/This a] could be done. 10 Q. [Well/Well,] to make 11 [them/they mean], the outcome, the is it a {TEUS} 12 calendar outcome and the event or 13 [in/inch/I know/I knew] consistent terms were 14 used, near or the same as the outcome where 15 [in/inch/I know/I knew] consist {STEPBLTS} terms 16 are used, wouldn't somebody have to make the 17 [in/inch/I know/I knew] consistent terms 18 consistent? 19 MR. GOLDMAN: 20 MR. GOLDMAN: Let {AOE} object 21 [to the/to tell] question, I think she answered 22 [that/this a]. 23 Q. You said it could be done? 24 A. Yes. Page 85 1 Q. Is there [any way/anyway] 2 [that/this a] the case where the consistent terms 3 are used and the case where the 4 [in/inch/I know/I knew] consistent terms are 5 used, cover have near or identical outcomes where 6 the [in/inch/I know/I knew] consistent terms are 7 not changed to consistent terms? 8 A. Yes. 9 Q. [What/When a] [what's/what is] 10 [that/this a] situation? 11 A. [I mean/I'm/I am] sure there 12 are some events [that/this a] [Oh,/owe/oh] {KWUR} 13 [that/this a] just [buy/by] chance investigators 14 are using consistently [and/on]. 15 Q. But [that's/that he's/that is]? 16 MR. GOLDMAN: 17 MR. GOLDMAN: Let [hear/here] finish go 18 [ahead/a head] finish {EURB} your question. 19 A. In [that/this a] case, making 20 [them/they mean] consistent would have had 21 [know/no] affect. 22 Q. Because [they would/they'd] 23 have already been consistent? 24 A. True. Page 86 1 Q. [So/sew]? 2 Q. All right. 3 Q. I don't want to argue with you 4 but it sounds to me like in the in the case where 5 the event are terms are [in/inch/I know/I knew] 6 consistent, in order to make [them/they mean] 7 have the same outcome as a situation where the 8 term are consistent? 9 A. The only [way/weigh] to do 10 [that/this a] is to change the 11 [in/inch/I know/I knew] consistency to make the 12 [in/inch/I know/I knew] consistent events term 13 consistent. 14 MR. GOLDMAN: 15 MR. GOLDMAN: If 16 [that's/that he's/that is] a question 17 [I object/I be] [to the/to tell] form because 18 [that/this a] mace {KRAEURBG} risks her earlier 19 testimony. [She is/She's/She say] given you a 20 couple of examples, I think of about how they 21 [that/this a] could be accomplished but she 22 hadn't said [that/this a] [what/when a] 23 [you are/you're/your] suggesting is the only 24 [way/weigh] [and/on] thus [I object/I be] Page 87 1 [to the/to tell] form. 2 Q. {HRE} me try to get specific. 3 [Refer/Referrer] to exhibit [10/ten] of 4 [doctor/Dr./Doctor,/Doctor] Jamie Street 5 deposition? 6 MR. GOLDMAN: {SKWR} [well/well,] can 7 we see it. 8 MR. GOLDMAN: 9 MR. GOLDMAN: Are you going to question 10 this witness about this exhibit. 11 ATTORNEY 1: 12 ATTORNEY 1: Not specifically, 13 [I mean/I'm/I am] just going to ask her about 14 some event terms within [that/this a] exhibit. 15 MR. GOLDMAN: 16 MR. GOLDMAN: [What/When a] do you want 17 to do with this {KPEUBLT}. 18 ATTORNEY 1: 19 ATTORNEY 1: [Well/Well,] at one 20 deposition, [I had/I'd] an exhibit from a pry or 21 deposition, you said you didn't want to remash 22 it. 23 MR. GOLDMAN: 24 MR. GOLDMAN: If you want it Page 88 1 [refer/referrer] to this do you want her to reads 2 this exhibit. 3 ATTORNEY 1: 4 ATTORNEY 1: Sure I think she can read 5 it, I think [may be/maybe] she should read it 6 [and/on] [then/they knew/they know] 7 [I will/I'll/ill] ask her some 8 [questions/question is]. 9 MR. GOLDMAN: 10 MR. GOLDMAN: The [hole/whole] 11 [thing/think] or certain parts. 12 ATTORNEY 1: 13 ATTORNEY 1: [I will/I'll/Ill] look 14 [threw/through] it [and/on] she might not have to 15 read the [hole/whole] [thing/think]. 16 ATTORNEY 1: 17 ATTORNEY 1: 18 ATTORNEY 1: For instance referring to 19 {KPHEUBT} [10/ten] from the 20 [doctor/Dr./Doctor,/Doctor] Jamie Street 21 deposition, page [numb/number] p z [9/nine] 22 [83/'83/eighty-three] sixty-three [4/four], 23 [there is/there's/theirs] a request from done 24 appear son, the [clinically/clinical] research Page 89 1 administrator to quote please change term suicide 2 attempt to overdose end quote. [Objecting/okay]. 3 Just basically is [miss/Ms./Miss] Pearson 4 attempting to make consistent events terms 5 [their/there/they're]. 6 MR. GOLDMAN: 7 MR. GOLDMAN: Wait a minute before you 8 answer it Greg let me object [numbering/numbing] 9 [1/one] if [you are/you're/your] going to 10 question the witness about the exhibit, you need 11 to show the witness the exhibit, second even 12 [to the/to tell] extent [that/this a] she ever 13 [saw the/sought] exhibit [ones/once] you show it 14 it to her, [you are/you're/your] asking her to 15 speculate {TAOS} [what/when a] Mrs. Pearson was 16 communicating to another person about [and/on] 17 [I mean/I'm/I am] not going to allow her {O} to 18 answer any [questions/question is] unless 19 [she is/she's/she say] shown specific exhibits 20 that's not appropriate {STKPWRAO} as far as 21 [you are/you're/your] aware. Did anybody at 22 {AOE} lie Lilly [ever/every] attempt to make the 23 term suicide attempt into an event term of the 24 [clinically/clinical] trials which were pooled Page 90 1 for the pooled resources. 2 MR. GOLDMAN: 3 MR. GOLDMAN: Make it into 4 [what/when a]. 5 Q. Did they ever try to make it 6 into anything else into a consistent events 7 {TPERPL}, did they ever try to change the term 8 suicide attempt to another term [so/sew] 9 [that/this a] it would be consistent throughout 10 the [17/seventeen] trials? 11 MR. GOLDMAN: 12 MR. GOLDMAN: Is your question 13 [without/would you tell] record to any specific 14 document that you might have been looking at 15 [2/two] minutes ago. 16 ATTORNEY 1: 17 ATTORNEY 1: Yes. 18 MR. GOLDMAN: 19 A. [What's/What is] the question 20 have I [what's/what is] the question. 21 Q. Has anybody at Lilly, including 22 you [ever/every] attempted to make a consistent 23 event term for suicide attempt across the 24 [17/seventeen] trials? Page 91 1 A. [It's/Its] still difficult to 2 answer. [Forth/For the/Fourth] manuscript, we 3 tried to define [a/an] [set/is he the] of terms 4 [that/this a] [may be/maybe] a suicide attempt. 5 Q. {ORBG}. 6 A. In [that/this a] [sense/since], 7 yes. 8 Q. When you did [that/this a], did 9 you take [a/an] {SRAEUR/KWRAEUGS} of other 10 terms [and/on] change those are terms to suicide 11 a tempt? 12 A. [What/When a] do you mean 13 [buy/by] changed. 14 Q. [I mean/I'm/I am] for instance 15 if a patient had overdosed would that be changed 16 to suicide attempt [forth/for the/fourth] purpose 17 of [you are/you're/your] manuscript? 18 A. It would not be changed in the 19 data base but wild count it as a suicide a tempt 20 for our manuscript. 21 Q. {EUFRPLTS} if that was the 22 intent of the overdose? 23 Q. Is there a list of terms that 24 would be counted as suicide attempt Page 92 1 [forth/for the/fourth] purpose of 2 [you are/you're/your] manuscript {EUFRPLT} yes? 3 Q. Do you know where [that/this a] 4 list might be found? 5 A. Yes. 6 Q. Where? 7 A. [I mean/I'm/I am] pretty sure 8 [that's/that he's/that is] described thoroughly 9 in one of the [first/1st] reports 10 [to the/to tell] FDA. 11 Q. Okay. . [Down/do you know] for 12 {AL} fact if the term overdose was [on/and] 13 [that/this a] list? 14 A. [I mean/I'm/I am] almost sure 15 [that/this a] it was. 16 Q. [House/How's/How is] suicide 17 attempt defined [forth/for the/fourth] purpose of 18 [that/this a] manuscript {SEUFRPBLGTS} any 19 behavior [that/this a] can be considered wanting 20 self harm? 21 Q. Would the suicide attempt have 22 to be listed [on/and] any area of the 23 [clinically/clinical] report form in order for 24 the stat {STEUGS} [is/\S] to recognize it as a Page 93 1 suicide attempt? 2 MR. GOLDMAN: Let me object 3 [to the/to tell] form. 4 ATTORNEY 1: 5 Q. As a case where a suicide 6 attempt occurred {STKPWRAO}? 7 MR. GOLDMAN: 8 MR. GOLDMAN: Let {AOE} object 9 [to the/to tell] form of question 10 [to the/to tell] extent it [a/an] {SAOUPLT} the 11 stat {STEUGS} was making some sort of [a/an] 12 [clinically/clinical] jump as to what was or what 13 was not a suicide attempt 14 [that's/that he's/that is] a medical question 15 [that's/that he's/that is] {THOT} qualified to do 16 [that/this a]. 17 Q. In the manual that you were 18 working [on/and] that was published in British 19 medical journal are case report forms discussed 20 in [that/this a] manuscript? 21 A. [Probable/probably]. 22 Q. Do you recall whether or not 23 [it's/it is] mentioned in [that/this a] 24 manuscript [that/this a] information about Page 94 1 suicide attempts was gored from the case report 2 forms? 3 A. I don't recall exactly 4 [what/when a] it said. 5 Q. Do you know what a case report 6 form is? 7 A. Yes. 8 Q. [And/On] do you know where 9 information is entered onto the case report form, 10 information about certain [let's/lets] say 11 adverse events? 12 A. Yes. 13 Q. Okay. . [Is that/is this a] 14 information entered in response to one question 15 or in one area on the case report form or is it 16 listed in [2/two], [3/three] or [mother/more] 17 places [on/and] case report form? 18 MR. GOLDMAN: 19 MR. GOLDMAN: [I object/I be] 20 [to the/to tell] form [what/when a] do you mean 21 by that information. 22 ATTORNEY 1: 23 ATTORNEY 1: About suicide attempt. 24 A. . Page 95 1 A. The investigator or the study 2 coordinator fills out the case report form 3 [and/on] I would say in some cases, yes, 4 [it's/it is/its] in more than one location. 5 Q. Okay. . Did the stat {STEUGS} 6 [is/\S] or did the stat {STEUGS} [is/\S] have 7 anything to do with designing the case report 8 form? 9 MR. GOLDMAN: 10 MR. GOLDMAN: [Forth/For the/Fourth] 11 [17/seventeen] [clinically/clinical] trials. 12 ATTORNEY 1: Yes. 13 A. {-P} [probable/probably]. 14 Q. {KWRLTD} the stat {STEUGS} 15 [is/\S] be involved with [that/this a] if 16 [their/there/they're] not going to read directly 17 from it [and/on] take information from it? 18 A. To be sure [that/this a] the 19 data [that's/that he's/that is] needed 20 [forth/for the/fourth] the analyses is collected. 21 Q. Okay. . Now, is {STKPWHRAOT} 22 suicide attempt information would be listed in a 23 different [place/plays] {OBTS} case report form 24 than information about the none efficacy of Page 96 1 Prozac, wouldn't it? 2 A. . 3 MR. GOLDMAN: 4 MR. GOLDMAN: [I object/I be] 5 [to the/to tell] form [what/when a] do you mean 6 by the none efficacy of Prozac. 7 Q. {EUPLT} if [a/an] 8 [clinically/clinical] {SRELGTD/TOR} determined 9 [that/this a] Prozac did not work [on/and] a 10 specific patient, would [that/this a] information 11 be in [a/an] [place/plays] different than where 12 the suicide attempt information would be on the 13 case report form? 14 MR. GOLDMAN: 15 MR. GOLDMAN: [I object/I be] 16 [to the/to tell] form only {TPOT/EBGS} 17 {TPEPBLTS} that the studies were blind {-TSDZ} as 18 she previously testified [so/sew] your question 19 assumes a facts [that/this a] not 20 [evidence/evident] [that/this a] 21 [their/there/they're] would be reference to 22 specific drug efficacy as opposed to drug or 23 {PHRA/SAOEB/PWOE} or a comparitor. 24 Q. You were about Page 97 1 [toss/to say/thoracic outlet syndrome] something 2 before [you are/you're/your] [attorney/torn] 3 {OBTD}? 4 A. [What's/What is] the question 5 again. 6 Q. Is information about the 7 efficacy of Prozac listed [on/and] case report 8 form? 9 A. Yes. 10 Q. Okay. . Is it listed in a 11 different [place/plays] than where information 12 about suicide attempt is listed? 13 A. In most cases. 14 Q. Okay. . [So/sew] if say Wheadon 15 after patient [in a/in an] clinical investigation 16 who was taking Prozac but the Prozac didn't work 17 [so/sew] the patient remained depressed [and/on] 18 attempted suicide, would [that/this a] event or 19 not event would [that/this a] situation be listed 20 as an adverse event? 21 A. ,The investigator would need to 22 make [that/this a] judgment. 23 Q. Okay. , the the investigator 24 made the judgment [that/this a] Prozac was a none Page 98 1 he have {KAEU/SHUS} or the {PHRA/SAOEB} 2 {PWOE} was not he have {KAEU/SHUSZ}, if the 3 investigate {TOR} made [that/this a] judgment, 4 would that have been picked up in 5 [you are/you're/your] study of the [17/seventeen] 6 [clinically/clinical] trials as a suicide 7 attempt? 8 MR. GOLDMAN: 9 MR. GOLDMAN: Wait a minute let me 10 object [to the/to tell] form when you say would 11 [that/this a] be picked up is the [that/this a], 12 the none efficacy determination or the 13 [that/this a] the suicide attempt 14 [that's/that he's/that is] recorded somewhere 15 else on the form [that's/that he's/that is] 16 [what's/what is] unclear about the question. 17 Q. [Objecting/Okay] can 18 {STKPWHRAOEUFRPBLGTS}? 19 (THE COURT REPORTER READ BACK THE 20 REQUESTED TESTIMONY.) 21 {STKPWHRAOEUFRPBLGTS} 22 ATTORNEY 1: 23 ATTORNEY 1: 24 Q. {EULG} rephrase the question, Page 99 1 [objecting/okay]? 2 Q. If there was a situation where 3 [a/an] [clinically/clinical] investigator 4 determined [that/this a] because [a/an] 5 [patience/patients/patient's/patient] [a/an] 6 {TERPLT} [had/dollars] sue attempted suicide, 7 Prozac or the {PHRA/SAOEB/PWOE} was not 8 working to [a/an] [leave/leaf] {KWRAEUT} the 9 depression {SUFRTDZ} [buy/by] [that/this a] 10 patient, [their/there/they're] father 11 [clinically/clinical] investigate {TOR} 12 determined [that/this a] the drug was not he have 13 {KAEU/SHUS} [on/and] this patient, [and/on] he 14 [he know/he knew/EN\] {TKERD} [that/this a] 15 information [on/and] the [clinically/clinical] 16 report form in the area [that/this a] we 17 discussed earlier, the air I can't that would be 18 for listing the fact [that/this a] the drug was 19 not he have {KAEU/SHUS}, would [that/this a] 20 information have been picked up in 21 [you are/you're/your] {STEUD} I as a suicide 22 attempt? 23 A. Yes if there was something in 24 the case report form [that/this a] indicated Page 100 1 [that/this a] there was a suicide attempt. 2 Q. Would [that/this a] indication 3 have to be in the adverse events area of the 4 [clinically/clinical] report form? 5 A. No. 6 Q. Where would [it be/it been], of 7 all the places possible? 8 A. . 9 MR. GOLDMAN: 10 MR. GOLDMAN: [I object/I be] 11 [to the/to tell] form, I think 12 [she is/she's/she say] answered [that/this a] 13 {TKPWRAEG}, she said it could be anywhere, if it 14 was anywhere on the form, [it will/it'll] being 15 picked up was I think her answer. 16 Q. [Is that/Is this a] 17 [you are/you're/your] answer? 18 A. We I can't say yes for sure but 19 [I would/I'd] say we did [what/when a] we could 20 [so/sew] [that/this a] that would be true. 21 Q. Okay. . Does that mean 22 [that/this a] if the words suicide attempt were 23 anywhere [on/and] [that/this a] 24 [clinically/clinical] report form, you did Page 101 1 [what/when a] you could to pick [that/this a] up? 2 A. Okay if suicide attempt was in 3 the case report form, we picked it up. 4 Q. Okay. [know/no] matter where 5 it was entered on the case report form? 6 A. [That's/That he's/That is] 7 true. 8 Q. Okay. . 9 A. If something other than 10 [that/this a] was said, we [may/May]. 11 Q. Are you familiar with the 12 protocols of those [17/seventeen] 13 [clinically/clinical] trials? 14 A. [I have/I've] 15 [generally/general] familiar with 16 [them/they mean]. 17 Q. Do you know whether or not a 18 patient was dropped from the individual clinical 19 investigations if the Prozac {PHRA/SAOEB} 20 {PWOE} or drug [that/this a] the patient was 21 taking was considered to be none he have {KAEU} 22 {SHUS} [bite/buy the/by the] investigator? 23 A. Yes. 24 Q. Yes you do [know/no] or yes the Page 102 1 patient was dropped? 2 A. Yes there are patient who do 3 drop out of studies because of lack of efficacy. 4 Q. Now in the particular situation 5 with Prozac, the patient would not be 6 [leave/leaf] {KWRAEUT} [had/dollars] of the 7 symptoms of depression in the events of none 8 efficacy, is that right? 9 Q. [I will/I'll/Ill] rephrase the 10 question? 11 A. Thank you. 12 Q. Okay. . If in [a/an] clinical 13 investigation regarding Prozac the drug was 14 considered to be none he have {KAEU/SHUS}, does 15 that mean [that/this a] the patient would 16 continue with the symptoms of depression? 17 MR. GOLDMAN: 18 MR. GOLDMAN: Before {AOE} answer, let 19 me object [to the/to tell] form because now I 20 think you crossed into the [severe/sphere] of 21 medical opinions a to {WHRO} if the drug was not 22 he have {KAEU/SHUS} symptoms of depression 23 would continue in [a/an] undefined {PAEURB}, 24 [numb/number] [1/one] [it's/its] [who're/who are] Page 103 1 {PWHRAOEU} vague because it's not speck as to a 2 {PAERBT} [and/on] it requires a medical opinion 3 [and/on] it [doesn't/don't] take into account the 4 studies blinded. 5 Q. [Well/Well,] I said the drug 6 [and/on] [so/sew] [I mean/I'm/I am] a Prozac 7 {PHRA/SAOEB/PWOE}, whatever the patient is 8 being exposed to? 9 MR. GOLDMAN: 10 MR. GOLDMAN: I withdraw [that/this a] 11 part of my [objection/ox/oxygen]. 12 Q. Where did you learn or how 13 [down/do you know] [that/this a] a patient was or 14 a subjects were dropped as a result of the none 15 efficacy of the drug which to which they were 16 exposed? 17 A. I learn [in a/in an] from the 18 data, [there is/there's/theirs] a field 19 [that/this a] we collect a reason for discontinue 20 {WAEUGS} [and/on] there are patient who 21 [cite/sight/site] the reason {TPAOR} lack of 22 efficacy or physicians. 23 Q. Now,? 24 A. {AEU}. Page 104 1 A. I assume [it's/its] {-P} 2 patient. 3 Q. If a subject is dropped from 4 the clinical investigation, because the drug 5 which they are exposed to is none he have {KAEU} 6 {SHUS} in the case of the Prozac clinical 7 investigation, the subject would not have been 8 [a/an] [leave/leaf] {KWRAEUT} [had/dollars] of 9 the symptoms of depression is that correct? 10 MR. GOLDMAN: 11 MR. GOLDMAN: 12 A. I don't know. 13 MR. GOLDMAN: 14 MR. GOLDMAN: Same 15 [objection/ox/oxygen] though because it calls 16 upon her to give a medical opinion as to 17 [what/when a] look of efficacy minds [and/on] 18 continuation of depressive symptoms. 19 Q. [Down/Do you know] of lack of 20 efficacy meanings? 21 A. [In/Inch/I know/I knew] 22 [what/when a] it means 23 [tomorrow/topple/to my/to me]. 24 Q. [What/When a] does it Page 105 1 [mean/me know] to you? 2 A. [That/This a] they are 3 [that/this a] [what/when a] they are, the 4 [they were/therapy] [that/this a] 5 [their/there/they're] take something not making 6 [them/they mean] better. 7 Q. That's not working? 8 Q. [It's/It is/Its] not working is 9 that right, [it's/its] just not making {THEPLG} 10 better? 11 A. [And/On] to [what/when a] 12 degree, it makes [them/they mean] better 13 [may be/maybe] different from patient to patient. 14 Q. Okay. . 15 A. [May be/Maybe] someone would 16 say it's not working if if [their/there/they're] 17 not [a/an] hundred percent better [and/on] cured 18 where as another patient might be satisfied with 19 being a little bit better. 20 Q. Okay. . 21 Q. [So/Sew] when I use the term 22 lack of he ever can a {SEU} [is that/is this a] a 23 term [that's/that he's/that is] {PAOE} cure 24 {HRAR}ly medical to you or do you understand Page 106 1 [what/when a] [that/this a] means? 2 A. . 3 MR. GOLDMAN: 4 MR. GOLDMAN: [I object/I be] 5 [to the/to tell] form, [she is/she's/she say] 6 told you [what/when a] she under [stance/stands] 7 it [we've/we have] already established 8 [she is not/she's not] [a/an] {TKR-RBGS} she can 9 testify as to [what/when a] she understand, 10 certainly. 11 Q. [Down/Do you know] how many 12 {SUBTSD} were dropped from the [17/seventeen] 13 studies due to lack of efficacy? 14 A. Not [off/often] the top of my 15 head. 16 Q. [Is that/Is this a] mentioned 17 in the manuscript? 18 A. I don't know. 19 Q. Was [that/this a] 20 [told/totaled] [to the/to tell] FDA? 21 A. I think . 22 Q. Certainly if those {-P} 23 subjects had been [included/concluded] in the 24 [final/finally] is it a {TEUS} calendar analysis, Page 107 1 the is it a {TEUS} sticks presented in the 2 manuscript would have been different wouldn't 3 they? 4 MR. GOLDMAN: {SKWR} let {AOE} object 5 [to the/to tell] form [to the/to tell] extent 6 [you are/you're/your] assume {LG} I believe in 7 your question [that/this a] {PERPBTS} 8 [that/this a] discontinued or dropped for lack of 9 efficacy were not considered in any a statistical 10 analysis [and/on] I don't know whether 11 [that's/that he's/that is] been established one 12 {AEU} or the other [you are/you're/your] a assume 13 {TLG/HAPBT}. 14 Q. Were they considered in the is 15 it a {SEUS} calendar analysis? 16 A. Yes. 17 Q. [So/Sew] people who are dropped 18 from the study, subjects who are dropped from the 19 study were considered in the statistical 20 analysis? 21 A. Yes. 22 Q. [What/When a] if they were 23 dropped from the study [well/well,] was 24 [their/there/they're] [a/an] Page 108 1 [time frame/timeframe] from which they were 2 dropped from the {STKUD} I [wherein/where in] 3 [they would/they'd] be considered 4 [forth/for the/fourth] the is it a {TEUS} 5 calendar [a/an] {TPHAL/SEURPBLGS} all data 6 collected while {THAP} patient was in the study 7 was considered for statistical [a/an] {TPHAL} 8 advice? 9 Q. Okay. . Is? 10 Q. The [clinically/clinical] 11 trials, the [17/seventeen] [clinically/clinical] 12 trials, how long were they in duration, they were 13 [a/an] [University/union] {TPAOEUD/-P} lengths 14 weren't they? 15 A. [5/Five] to [6/six] weeks 16 [on/and] treatment [and/on] 17 [then/they knew/they know] [usual/usually] a 18 [1/one] [weak/week/we can] placebo lead in. 19 Q. [So/Sew] [you had/you'd] 20 [5/five] to [6/six] weeks [and/on] treatment for 21 all [17/seventeen] [clinically/clinical] trials? 22 A. Yes. 23 Q. [So/Sew] [we are/we're] talking 24 about [6/six] to [7/seven] weeks due {RAEUGSZ} Page 109 1 [forth/for the/fourth] [clinically/clinical] 2 trials is that correct? 3 A. That's correct. 4 Q. [And/On] [nip/in my opinion] 5 subject [that/this a] dropped out during those 6 [6/six] to [7/seven] weeks [forth/for the/fourth] 7 purpose of none efficacy was [included/concluded] 8 in the is it a {TEUS} calendar analysis 9 [that/this a] eventually became the manuscript of 10 the [17/seventeen] pooled [clinically/clinical] 11 trials? 12 A. Yes. 13 Q. Okay. . How many -- I think I 14 asked you [that/this a]. 15 Q. Did any of {THOEPS} subjects 16 who dropped out attempt suicide? 17 A. I don't know. 18 Q. ? 19 A. Not [off/often] the top of my 20 head. 21 Q. In [you are/you're/your] study 22 [that/this a] involved the [17/seventeen] pooled 23 [clinically/clinical] trials, suicide attempt was 24 [that/this a] a pry or the consideration of Page 110 1 [that/this a] trial? 2 MR. GOLDMAN: 3 MR. GOLDMAN: Let me object 4 [to the/to tell] form, [what/when a] do you mean 5 [buy/by] a proper or the consideration of 6 [that/this a] trial. 7 Q. [I mean/I'm/I am] were you 8 frying to [find/fined] the answer or information 9 about suicide [a/an] {TEPLTSD}? 10 MR. GOLDMAN: 11 MR. GOLDMAN: At [what/when a] point in 12 in time. 13 ATTORNEY 1: 14 ATTORNEY 1: 15 Q. While you were conducting the 16 is it a {TEUS} calendar analysis of the 17 [17/seventeen] pooled trials? 18 A. Yes. 19 Q. [And/On] that was also a pry or 20 the consideration of the [17/seventeen] 21 individual clinical investigations is that 22 correct? 23 MR. GOLDMAN: 24 MR. GOLDMAN: Same Page 111 1 [objection/ox/oxygen] as to pry or the 2 consideration is being awful have a vague 3 [and/on] ambiguous. 4 Q. [Well/Well,] it was a 5 consideration that was substantially important to 6 you, [right/write] {EUFRPLTD} to me 7 [personal/personnel/personally]? 8 Q. To the stat {STEUGS} [is/\S], 9 not to you [personal/personnel/personally] but to 10 you in [you are/you're/your] [role/roll] 11 [role/roll] as a stat {STEUGS}? 12 A. Are we referring 13 [to the/to tell] analysis of the [17/seventeen] 14 trials. 15 Q. [We are/We're] referring 16 [to the/to tell] individual trials all 17 [17/seventeen], information about suicide 18 attempts was also a pry or the consideration of 19 those individual trials was it not? 20 A. I was not part of the planning 21 process for those [17/seventeen] trials but all 22 safety issues is a concern for all of these 23 trials. 24 Q. [I mean/I'm/I am] talking Page 112 1 specifically about suicide, suicidal ideation, 2 suicide [a/an] {TEPLGTS}, it was a pry or the 3 consideration of those [17/seventeen] individual 4 clinical investigations was it not? 5 A. . 6 MR. GOLDMAN: 7 MR. GOLDMAN: [I object/I be] 8 [to the/to tell] form only [to the/to tell] 9 extent Greg [she is/she's/she say] answered it a 10 minutes ago [to the/to tell] best she could she 11 told you [what/when a] involvement she did or 12 didn't have [and/on] she told you about safety 13 concerns [and/on] you asked her a question about 14 this event an hour ago. 15 Q. Now, in [addition/edition] to 16 designing {KHRAOEUPBL} trials [it's/its] part of 17 the [role/roll] of the stat {STEUGS} obviously to 18 value the results of the [clinically/clinical] 19 trial [is that/is this a] true? 20 A. [That's/That he's/That is] 21 true. 22 Q. Is one of the [things/thinks] 23 [that/this a] a stat I say {STEUGS} will look at 24 the [numb/number] of reported side Page 113 1 [affects/effects]? 2 A. [We've/We have] a part in 3 [that/this a], yes. 4 Q. Can you describe to me 5 [what/when a] [that is/that's]? 6 A. In most, I would say most stat 7 {STEUGS} [is/\S] will look at the reports 8 [that/this a] contain the [numbers/numbs] of 9 [patience/patients/patient's/patient] [and/on] 10 percentage of the patient [that/this a] reported 11 [what/when a] events. 12 A. All the different events. 13 [Whoever/However] [we are/we're] are not, we do 14 not produce those reports [usual/usually]. 15 Q. Okay. . 16 Q. If say you were looking at 17 [a/an] [add/ad] version event such as suicide 18 [objecting/okay] or let's say you were looking at 19 a broader event, [death/debt/did he tell], 20 [objecting/okay], [so/sew] say [you had/you'd] 21 [26/twenty-six] reports of [deaths/debts] 22 [and/on] opinion closer review of why people died 23 while [on/and] pros, it came out [that/this a] 24 [15/fifteen] died [buy/by] suicide. Would that Page 114 1 be would that be an at all of interest 2 [to the/to tell] stat {STEUGS} will investigating 3 side [affects/effects]? 4 A. . 5 A. Are we talking 6 [generally/general] now or are we still referring 7 to this particular analysis and the 8 [17/seventeen] trials. 9 Q. [We are/We're] talking 10 [generally/general]? 11 A. [Generally/general]. 12 [Generally/general], [know/no], we, 13 [it's/it is/its] the research physicians 14 [responsibility/responsible] to look at events, 15 be familiar with the event [and/on] we 16 [doesn't/don't] [it's/its] becomes our, if the 17 [figures/physician] has a special concern 18 [and/on] wants to look at something a little 19 [mother/more] closely, [then/they knew/they know] 20 the [figures/physician] will approach 21 [us/you say] with a particular question [and/on] 22 {THAEPB} they say when we would get involved. 23 Q. Okay. . [Let's/lets] take about 24 the [way/weigh] [that/this a] suicidality was Page 115 1 measured in the [17/seventeen] trials 2 [that/this a] were pooled, do you know who it was 3 measured, suicidality? 4 A. Yes. 5 Q. How was [that/this a]? 6 A. A number of different 7 [waste/ways/weighs/waist]. 8 Q. [What/When a] were those 9 [waste/ways/weighs/waist]? 10 A. [One-way/One way] was measured 11 [buy/by] looking at whether or not {AP} patient 12 did have a suicide attempt or had suicide the 13 ideation [buy/by] having some indication [on/and] 14 [their/there/they're] case report form 15 [that/this a] [that's/that he's/that is] true 16 [and/on] the real, the detailed definition it was 17 [mother/more] the research physician {-SZ} 18 [responsibility/responsible] [and/on] I can't 19 [refer/referrer], [doesn't/don't] [note/know the] 20 the detailed definition too [well/well,]., 21 Another sue said {TKALT} was also [a/an] {STES} 22 [had/dollars] using the Hamilton depression 23 scale, item [3/three] which is a question about 24 suicidality [and/on] it was [a/an] Page 116 1 [cease/sees/seize] {SES} [had/dollars] in 2 [that/this a] [way/weigh]. [And/On] those are 3 the [2/two] primary [waste/ways/weighs/waist] 4 [it's/it is/its] been assess {STKPWHRAOD} 5 [objecting/okay]. The [first/1st] [way/weigh] 6 [that/this a] suicidality is assessed, 7 [that's/that he's/that is] primarily the 8 physicians [role/roll],. 9 A. Yes, the physicians 10 [defines/defined] [what/when a] it meant to have 11 an event, a suicide event. 12 Q. Uh-huh? 13 A. [And/On] 14 [then/they knew/they know] they. 15 Q. [I mean/I'm/I am] not sure 16 [what/when a] [that/this a] has to do with 17 measuring suicidality it sounds? 18 MR. GOLDMAN: 19 MR. GOLDMAN: Let me object 20 [to the/to tell] form only that you may not be 21 sure but you asked her [what/when a] the mess 22 {AOURSZ} were [and/on] show told you. 23 ATTORNEY 1: 24 ATTORNEY 1: Page 117 1 Q. Right [and/on] you 2 [told/totaled] me of [a/an] [figures/physician] 3 identifying suicidality. 4 [what I mean/what I'm/what I am] interested in is 5 how it was [actual/actually] measured. You see 6 with the Ham-D [3/three], you can apply a number? 7 A. Right . 8 Q. [So/Sew] 9 [that's/that he's/that is] how [it's/its] 10 measured. [So/Sew] in the [first/1st] case, 11 [house/how's/how is] it measured? 12 A. A little [bit/by the] 13 [mother/more] subjectively, [it's/its] measured 14 [buy/by] adverse events on the adverse events 15 page of a case report form where they list an 16 event as measure it as mild {-RBG/PHOD} rate or 17 [severe/sphere]. It could be collected as part 18 of a reason for discontinue {WAEUGS} which you 19 [doesn't/don't] have in [that/this a] case if it 20 was collected in [that/this a] part of the form, 21 you [doesn't/don't] have [a/an] [severe/sphere] 22 {REUTD} measure, it could be a comments in the 23 comments page which [it's/its] measured 24 [then/they knew/they know] [whoever/however] Page 118 1 thorough [necessary/\NESS] the investigator got 2 on the comments pages. 3 Q. [How old/How would] you 4 investigator measure it on the comments page? 5 A. . 6 Q. With words or [numb/number]? 7 A. Words. 8 Q. Did he have [a/an] 9 [set/is he the] of words [that/this a] 10 [he would/he'd] use like mild, {PHOT} rate, 11 [severe/sphere]? 12 A. They [may/May] use those words. 13 Q. But he was free to use words as 14 he saw fits? 15 A. Yes. 16 Q. When you measured suicidality 17 for the manuscript [that/this a] 18 [we have been/we've been] discussed [go/\ing], 19 did you use this [first/1st] [way/weigh] of 20 measuring suicidality to come up with as part of 21 the is it a {TEUS} calendar analysis? 22 A. Yes. 23 Q. ? 24 A. That was done not [buy/by] that Page 119 1 was done [buy/by] the research physician with a 2 systems analyst [and/on] they made the 3 definitions of what was [a/an] {SREBTS} [and/on] 4 [ones/once] that was defined 5 [then/they knew/they know] [I had/I'd] the data 6 [and/on] others had the data. 7 Q. [So/Sew] what was the data, was 8 it just data [that/this a] said something like 9 mildly suicidal, mentioned in comment 10 [sex/section] [and/on] that was put into the 11 data? 12 A. As far as the data 13 [that/this a] was used for [a/an] {TPHAL/SEUSZ} 14 for [that/this a] manuscript, it was [a/an] yes 15 or no there was a suicide event. 16 Q. Okay. . 17 Q. Was the {HAOPL} 18 [d/degenerative] [3/three] [mother/more] 19 concerned with the degree of the sue 20 [site/cite/sight] attempt? 21 A. Yes. 22 Q. Now, how do you rate the Ham-D 23 [3/three] scale as a measurement of suicidality? 24 MR. GOLDMAN: Page 120 1 MR. GOLDMAN: Before {HAOE/AEPBGS} 2 let me object [to the/to tell] {TORPL} only 3 [to the/to tell] extent [that/this a] it the 4 question cause upon her at least in part to 5 render a medical opinion [on/and] how {TPO} 6 [race/raise] {OU} suicidality. 7 Q. I don't want [a/an] 8 [medical/med] {KWAL} opinion, I wants 9 [you are/you're/your] your opinion as a stat 10 {STEUGS} [and/on] [what/when a] [you have/you've] 11 is the Ham-D [3/three] scale. [Down/Do you know] 12 how many chases there are in [that/this a] scale? 13 A. [0/Oh] [threw/through] 14 [4/four]. 15 Q. [So/Sew] there are [5/five] 16 choices, [right/write]. 17 A. Yes. 18 Q. Do you know what the range of 19 those chases are? 20 A. . 21 Q. ? 22 MR. GOLDMAN: You mean [what/when a] 23 {KOR} response. 24 Q. [What/When a] correspondence to Page 121 1 zero, what {KWORS} response to [3/three], 2 [what/when a] correspondence to [4/four]? 3 A. Zero would [mean/me know] 4 [know/no] suicidal thoughts, [4/four] would 5 [mean/me know] an attempt. 6 Q. ? 7 A. [And/On] in between or are 8 different {HREFPLS} [that/this a] I don't recall 9 will specifically [what's/what is] associate {WD} 10 [them/they mean]. 11 Q. Okay. . 12 Q. Was [their/there/they're] 13 [a/an] university will definition for suicide 14 attempt used [bite/buy the/by the] 15 [clinically/clinical] investigators of those 16 [17/seventeen] trials? 17 MR. GOLDMAN: 18 MR. GOLDMAN: [I object/I be] 19 [to the/to tell] form used [had/dollars] the term 20 university will definition as being 21 [you know/you knew/you know,] [defines/defined]. 22 Q. Was [their/there/they're] 23 [a/an] {TKEFP/TPHEULGS} of suicide attempt 24 which was used [bite/buy the/by the] Page 122 1 [17/seventeen] [clinically/clinical] 2 investigators? 3 A. Are you referring to the Ham-D 4 item [3/three]. 5 Q. [Know/No] [I mean/I'm/I am] 6 talking in [generally/general], I want 7 [to know/ton] whether or not suicide attempt was 8 a phrase which was defined across the 9 [borrowed/board] [forth/for the/fourth] 10 [17/seventeen] investigators [so/sew] 11 [that/this a] when they came [to the/to tell] ham 12 b [3/three] [then/they knew/they know] 13 [d/degenerative] [3/three] 14 [then/they knew/they know] whether or not the 15 [numb/number] [47/forty-seven] was [a/an] 16 {PWHREUBG/ABL} or not? 17 A. The Ham-D [3/three] has 18 guidelines with [them/they mean], [0/oh] 19 [threw/through] [4/four], there are words 20 [that/this a] go [along/a long] with 21 [that/this a] to provide guidelines for 22 investigators {STKPHO}. 23 Q. [So the/Sew the] the 24 investigators [then/they knew/they know] were Page 123 1 left to [their/there/they're] own 2 [devices/devises] as to whether or not 3 [they would/they'd] check [off/often] [3/three] 4 or [4/four] on the ham {TKFPLTD} [3/three]? 5 MR. GOLDMAN: 6 MR. GOLDMAN: Will have [so/sew] evens 7 let me {AOBG/HREFPT} to [their/there/they're] 8 own advises an is a rather poor 9 [constitute/institute] to [what's/what is] likely 10 [am/a.m.] [clinically/clinical] judgment. 11 Q. The [clinically/clinical] 12 investigators were left to [their/there/they're] 13 own [clinically/clinical] jump as to whether to 14 check [off/often] ham as to whether to check 15 [off/often] [3/three] or [4/four] on the ham b 16 [3/three] is that correct? 17 A. Yes given [they've/they have] 18 these guidelines. 19 Q. [Well/Well,] now, given the 20 guidelines [and/on] given [that/this a] the 21 guidelines are interpreted [buy/by] 22 [17/seventeen] different people, right? 23 A. [What's/What is] the question. 24 Q. The question is is there {AL} Page 124 1 [way/weigh] to account for the differences in 2 judgments of the [17/seventeen] different people 3 in [a/an] {STRAO/TEUS/SKAL} analysis? 4 MR. GOLDMAN: 5 MR. GOLDMAN: As relates 6 [to the/to tell] ham b item [3/three]. 7 ATTORNEY 1: Yes. 8 A. Is it a {TEUS} stick {KHREU} 9 you can account for any investigator differences, 10 you can take [that/this a] {SRAEUR} ability into 11 account. [So/Sew] in [that/this a] {SEPBSZ}, 12 yes. 13 Q. Okay. can you was 14 [that/this a] done in this situation, the Ham-D 15 [3/three] situation in the manuscript that was 16 prepared as a result of pulling the 17 [17/seventeen] clinical investigations? 18 A. Yes. 19 Q. How was [that/this a] done? 20 A. Using the man tell {HAPB} 21 [sell/cell] [incidents/incident] difference 22 method allows you to account for any rare ability 23 between investigators [and/on] 24 [that's/that he's/that is] one method Page 125 1 [that/this a] we used for [that/this a] 2 manuscript. 3 Q. Can you describe how that was 4 done, I don't want you to get into a seminar 5 [on/and] man tell {HAPB} [sell/cell] but if you 6 can describe [generally/general] for lame man how 7 that was done using the man tell {HAPB} 8 [sell/cell], how was the {SRAEUR} ability of the 9 [clinically/clinical] investigators judgment 10 accounted for? 11 A. . 12 A. I guess we -- [that/this a] 13 method to get an estimate of the different in 14 suicidality between Fluoxetine continue [and/on] 15 a comparitor, we used [that/this a] method. 16 [That/This a] method come {PAOUT} [had/dollars] 17 [that/this a] different for each investigator 18 [and/on] [then/they knew/they know] took a 19 [baited/bathed] average of those difference {-SZ} 20 [so/sew] each investigator had a difference 21 between treatments [and/on] this in [that/this a] 22 [sense/since] as long as they were consistent 23 because [it's/its] a blinds [had/dollars] study, 24 we [a/an] [supple/sum] [their/there/they're] Page 126 1 consistent in in [their/there/they're] own 2 judgment, in [their/there/they're] own trial 3 [that/this a] we can an account 4 [then/they knew/they know] 5 [that's/that he's/that is] accounts [had/dollars] 6 for in [that/this a] [sense/since]. 7 Q. By the way, were 8 [their/there/they're] any clinical investigations 9 which were not [included/concluded] in this 10 pooling of resources [and/on] the reason they 11 were not [included/concluded] did not have to do 12 with any of the exclusion criteria of the pooled 13 study? In other words [they would/they'd] have 14 fit into the pooled study but for some reason 15 other than the exclusion criteria, they were not 16 [add/ad] the to the pooled study? 17 MR. GOLDMAN: 18 MR. GOLDMAN: Do you understand the 19 question. 20 A. Yes. 21 A. No. 22 MR. GOLDMAN: {SKWRAOEU} understood the 23 [first/1st] part of it. 24 Q. The question is, the Page 127 1 [clinically/clinical] study where you pooled the 2 [17/seventeen] clinical investigations, now, 3 [that/this a] in [and/on] of itself had exclusion 4 criteria, did it not? 5 A. {EBGS} [clues/includes] 6 criteria for which trials not to include. 7 Q. Right ? 8 A. Yes. 9 Q. For instance if a trial, this 10 is just an example, I really don't know but if a 11 trial only lasted two weeks, it would not have 12 been [included/concluded] in your study, 13 [right/write]? 14 A. Right . 15 Q. Because [you are/you're/your] 16 studies only [included/concluded] trials 17 [that/this a] lasted [5/five] to [7/seven] weeks? 18 A. Okay . 19 Q. All right. Now 20 [what I mean/what I'm/what I am] asking is were 21 [their/there/they're] any trials investigations 22 [that/this a] [you are/you're/your] aware of 23 [that/this a] were not [included/concluded] in 24 the pooling but fit into the criteria of the Page 128 1 pooling? 2 A. No. 3 Q. Was [ever/every] trial 4 [that/this a] fit into the criteria 5 [included/concluded]? 6 A. Yes. 7 Q. [So/Sew] [their/there/they're] 8 were [17/seventeen] trials [that/this a] fit into 9 the criteria? 10 A. Yes. 11 Q. ? 12 Q. Is it a sticks {KHREU} 13 [in a/in an] situation like the Ham-D [3/three], 14 wouldn't [it be/it been] better if 15 [their/there/they're] had been [10/ten] possible 16 [responsibilities/responses] instead of [5/five]? 17 MR. GOLDMAN: 18 MR. GOLDMAN: [I object/I be] 19 [to the/to tell] form when you say wouldn't it 20 have been better better than [what/when a] or for 21 [what/when a]. 22 Q. Wouldn't it have produced 23 [mother/more] is it a cities {KHREU} accurate 24 {RULGTSDZ} if [there had/there'd] been [10/ten] Page 129 1 possible [responsibilities/responses] 2 [in/inch/I know/I knew] {STEDZ} of [5/five]? 3 A. Depends [on/and] the specific 4 objective. 5 Q. [Is that/Is this a] another 6 situation where [it's/its] debatable? 7 A. No not really. 8 Q. If the objective was to 9 determine suicidality, suicide the will ideation, 10 thoughts of suicide, suicide attempts [and/on] 11 [actual/actually] attempt, would it have been 12 better to breakdown the range into [10/ten] 13 [mother/more] specific 14 [responsibilities/responses] than to have just 15 [5/five] [responsibilities/responses]? 16 MR. GOLDMAN: 17 MR. GOLDMAN: Is it a {TEUS/KHREU} 18 not medically. 19 ATTORNEY 1: 20 ATTORNEY 1: Is it a cities {KHREU}. 21 A. [It's/Its] still related 22 [to the/to tell] medical objective, if the 23 objective is to determine [there is/there's] a 24 different in the proportion of Page 130 1 [patience/patients/patient's/patient] who have a 2 suicide a will events of some sort, 3 [then/they knew/they know] all you need is 4 [2/two] levels, yes [and/on] [know/no]. 5 Q. But the objective is not 6 [that/this a], in the study, right, the objective 7 was to determine whether so-called suicidal 8 ideation [worse/worst] [end/ends]? 9 A. [That's/That he's/That is] 10 [you are/you're/your] [right/write], with 11 [that/this a] objective, you could get [buy/by] 12 with yes or no did it worsen. 13 Q. Okay. . You could get [buy/by] 14 with [that/this a], would [that/this a] be better 15 than having [a/an] [5/five] possible answer? In 16 other words you [doesn't/don't] just have [2/two] 17 now, [you have/you've] [5/five] [so/sew] 18 [that/this a] [it's/its] [mother/more] specific 19 as to [what/when a] occurred. Wouldn't having 20 [5/five] answer as the ham b [3/three] did be 21 better than having [is/\S] just [a/an] yes or no 22 response at h b [3/three]? 23 A. [It's/Its] it still seems like 24 a medical question, I don't know how to answer Page 131 1 [that/this a] is it a cities {KHREU}. 2 Q. Okay. sticks {KHREU} if you 3 were studying the degree of suicidality [and/on] 4 how it changed [had/dollars], [objecting/okay], 5 would [it be/it been] better to have the [5/five] 6 possible [responsibilities/responses] as in the 7 Ham-D [3/three] would [it be/it been] better than 8 having the question [that/this a] just said did 9 suicidality exist, yes or no, having [2/two] 10 possible [responsibilities/responses]? 11 A. Yes, if that was part of the 12 objective was to, yes try to [figure/if I go] out 13 different levels of {PORS/WEPBG}. 14 Q. Okay. , why would 15 [it be/it been] better? 16 A. You could [probable/probably] 17 you could answer you can answer [mother/more] 18 {KPWES} than just whether or not yes or no did 19 the event occur, you might be able to answer a 20 little bit [mother/more] specifically as to how 21 much an events {WAORS} [end/ends]. 22 Q. Okay. you could answer 23 [mother/more] [questions/question is] [and/on] 24 you could answer [mother/more] specifically, Page 132 1 [well/well,] [then/they knew/they know] couldn't 2 you answer even [mother/more] 3 [questions/question is] [and/on] be even 4 [mother/more] specific if [you had/you'd] 5 [10/ten] possible [responsibilities/responses] 6 than if [you had/you'd] [5/five] as at Ham-D? 7 A. [That's/That he's/That is] a 8 medical just a minute, I think [you have/you've], 9 [you would/you'd] want each level to make some 10 medical [sense/since] [and/on] if each level if 11 they can be made discontinuing than yes that 12 would be helpful. 13 Q. [Well/Well,] if 14 [that is/that's] the critical objective of this 15 study where you pulled [17/seventeen] studies, it 16 would seem to me [that/this a] [you would/you'd] 17 wanted the to answer as many 18 [questions/question is] [and/on] be as specific 19 as possible, [right/write]? 20 MR. GOLDMAN: 21 MR. GOLDMAN: Before [so/sew] answer 22 bet let me object [to the/to tell] form, I don't 23 know [that/this a] [it's/its] a proper question 24 in terms of [what/when a] whether she supposed to Page 133 1 degree how it seems to you to be, [so/sew] I have 2 been [to the/to tell] form of the question. 3 Q. ? 4 MR. GOLDMAN: 5 MR. GOLDMAN: I don't know if 6 [it's/it is] a question. 7 Q. Why did {AOE} lie Lilly pool 8 [17/seventeen] clinical investigations instead 9 [ever/every] just starting [a/an] [knew/new] 10 [clinically/clinical] trial that would cover as 11 many {-P} [patience/patients/patient's/patient] 12 as the individual investigations amounted to? 13 A. [In/Inch/I know/I knew] one 14 reason would be because if we did the latter, it 15 would be a very long time, it would take a very 16 long time to run [that/this a] [and/on] it seems 17 to me we {PWAPBLT} wanted to address the question 18 as quickly as we could. 19 Q. How long would such an 20 investigation have taken? 21 A. I don't know. 22 Q. Would it have taken longer than 23 the [7/seven] weeks of the [actual/actually] 24 trial? Page 134 1 A. Definitely. 2 Q. Would it have taken 2578 weeks? 3 A. [Probable/probably]. 4 Q. Was [their/there/they're] any 5 kind of deadline to come up with an is it a 6 {TEUS/SKAL} analysis? 7 MR. GOLDMAN: 8 MR. GOLDMAN: When you say this is it a 9 {TEUS/SKAL} analysis. 10 Q. I said to come up with a 11 statistical analysis, was [their/there/they're] a 12 deadline, was [their/there/they're] a reason you 13 pulled the [clinically/clinical] trials [so/sew] 14 that you could do it in a quicker time instead of 15 going out [and/on] starting over? 16 A. If there was safety concern 17 about suicide {S-RBGS} [and/on] if we thought we 18 can get some [mother/more] information from our 19 [clinically/clinical] trial data base, we thought 20 we needed to do [that/this a]. 21 Q. ? 22 A. With the current information 23 Wheadon. 24 Q. [And/On] [that/this a] Page 135 1 [way/weigh] [safe/save] time, [right/write]? 2 A. It gave an answer in a timely 3 [faction/fashion/fascia], not 4 [toss/to say/thoracic outlet syndrome] 5 [that/this a] we wouldn't consider, yes 6 furthering research at least it gave an answer 7 relatively quickly. 8 Q. Okay. . 9 A. [And/On] I [shouldn't/shunt] 10 say answer, we addressed the question with 11 [what/when a] Wheadon at the time. 12 Q. Now my question is was 13 [their/there/they're] any deadline within which 14 [you had/you'd] to come up with not an answer but 15 [you had/you'd] to come up with an is it a {TEUS} 16 {SKAL} analysis? 17 A. No. 18 Q. Did you have to do it before 19 the advisory committee meeting? 20 A. [Their/There/They're] were 21 analyses done before [we knew/we know] the 22 {SREUS/REU} committee meeting was going to 23 exist. 24 Q. [I mean/I'm/I am] talking about Page 136 1 the [17/seventeen]? 2 A. That was done before 3 [we knew/we know] the [actual/actually] meeting 4 was going to exist. 5 Q. You started [doing/dog] it 6 before the meeting? 7 A. Yes. 8 Q. When did you finish it by the 9 way? 10 A. . 11 A. I don't know, I don't know. 12 Q. Well, was the purpose of 13 [that/this a] study, the [17/seventeen] pool 14 pooled [clinically/clinical] trials to answer a 15 question as to how many subjects or [what/when a] 16 percent of subjects had [a/an] ham b [3/three] 17 score starting at either zero or [1/one] [and/on] 18 move up to [3/three] or [4/four]? 19 A. Yes. 20 Q. [Down/Do you know] when 21 [that/this a] question was [first/1st] considered 22 [buy/by] Eli Lilly and Company or when did you 23 [first/1st] [hereof/here of/hear of] 24 [that/this a] question within Page 137 1 [you are/you're/your] employment? 2 MR. GOLDMAN: 3 MR. GOLDMAN: Let {PAOE} object when 4 you say [that/this a] question, are you talking 5 about the change in the ham b score. 6 A. Yes. 7 Q. ? 8 A. That was [a/an] 9 [suggestion/suggests] [buy/by] con {SUL/TAPBTS} 10 [and/on] I don't remember when [that/this a] 11 consulting meeting was. 12 Q. Who were the consultant? 13 A. I don't know. 14 Q. Do you know where they were 15 from? 16 A. No, I don't. 17 Q. Who in {HREULG} I met with 18 these con {SUL/STAPBTSD}? 19 A. I {WAEUPBTSD} 20 [their/there/they're], I don't really [know/no] 21 who was [their/there/they're] 22 {STKPWHRAOEUFRPBLGTS}. 23 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 24 MARKED FOR IDENTIFICATION AND Page 138 1 RECEIVED IN EVIDENCE.) 2 {STKPWHRAOEUFRPBLGTS} 3 Q. [I have/I've] shown you 4 [plaintiff's/plaintiffs] Exhibit 1, 5 [I mean/I'm/I am] referring specifically to the 6 message on the bottom of the [first/1st] page 7 which runs over [to the/to tell] second page. I 8 believe you were copied [that/this a] message 9 weren't you? 10 A. Yes. 11 Q. Does [that/this a] message 12 refresh [you are/you're/your] memory regarding 13 when you [first/1st] heard [that/this a], the 14 question of how many subjects had [a/an] Ham-D 15 [3/three] score starting at zero to [1/one] which 16 elevated to an a score of [3/three] to [4/four]? 17 A. [Well/Well,] my this message is 18 dated July, 1990, the consultant 19 [meat/meet/me the] {LG} must have been before 20 [that/this a] [and/on] I heard about it 21 [probable/probably] around the {TAOEUPBL} this 22 message was written. 23 Q. Okay. . When you around the 24 time this message was written, had the any of the Page 139 1 work been done to pull the [clinically/clinical] 2 trial data of the [17/seventeen] 3 [clinically/clinical] {TRAOEULTS}, had any of 4 [that/this a] work been done or did all 5 [that/this a] start up after this message? 6 A. This message does pool the data 7 from the [17/seventeen] [clinically/clinical] 8 trials, the results [that/this a] are in this 9 message. 10 Q. Okay. [so/sew] [that/this a] 11 must [mean/me know] [that/this a] the data was 12 already pooled, [right/write] {SEUFRPBLGTS} 13 {PAOLTD} in [what/when a] [sense/since],, the 14 data, the Ham-D item [3/three] data from the 15 [17/seventeen] [clinically/clinical] trials were 16 used for this analysis? 17 Q. Okay. . {STKPWHRAO*} 18 {STKPWHRAOP} do you know what happened is 19 [well/well,] let me ask this, were any other 20 further analyses done with respect to 21 [that/this a] question from the point in time of 22 this message until the points in time when the 23 manuscript was {PUBTD} in the British medical 24 journal in [September/except] of '91? Page 140 1 A. Yes. 2 Q. Does the article in the British 3 medical journal {PHEUPBGSZ} those additional 4 analyses? 5 A. Yes. 6 Q. [And/On] are those analyses 7 different than [what's/what is] mentioned in this 8 [miss/Ms./Miss] age? 9 A. Some. 10 Q. Which [ones/once] are 11 different? 12 A. We in [that/this a] manuscript, 13 we showed a few different {PROEFPTS} to the 14 question. 15 Q. Okay. . 16 A. One [included/concluded] this 17 approach, where all data was pooled [and/on] we 18 [you had/you'd] percentage for each treatment 19 group. Another approach was just to look at 20 those trials [that/this a] had Fluoxetine 21 continue [and/on] {PHRA/SAOEB/PWOE} in 22 [them/they mean] [and/on] 23 [then/they knew/they know] {KHRAOEUT} 24 [had/dollars] the percent age for those trials Page 141 1 which was [know/no] longer [17/seventeen], it was 2 [7/seven] trials [and/on] 3 [then/they knew/they know] we looked at another, 4 [then/they knew/they know] we looked at the 5 trials [that have/that of] Fluoxetine continue 6 {PHRAUS} a tricyclic de{PRESZ} and the 7 [their/there/they're] were [12/twelve] 8 [12/twelve] trials {WAOPB} [and/on] we looked at 9 percentage in those trials [and/on] we 10 [loose/lose] used difference statistical methods. 11 Q. How long did all [that/this a] 12 which you just describe the {TAEUBLG}, how long 13 did it take you to complete all of [that/this a]? 14 A. . 15 A. Around [a/an] year 16 [probable/probably]. 17 Q. Still in is this July of 1990 18 or June of 1991 [0/oh]? 19 MR. GOLDMAN: 20 MR. GOLDMAN: July. 21 Q. In July of 1990, there was 22 concern about the answer to the question how many 23 subjects started at zero to [1/one] [and/on] went 24 up to [3/three] to [4/four]., [Right/write]? Page 142 1 A. [What's/What is] the question. 2 Q. There was some interest in 3 [that/this a] question? 4 A. Yes. 5 Q. At {AOE} lie Lilly? 6 A. Yes. 7 Q. [Down/Do you know] from where 8 [that/this a] interest came? 9 A. [That/This a] specific [a/an] 10 {TPHAL/SEUSZ}. 11 Q. Yes? 12 A. Came from [what/when a] I 13 understand one or a group of the of the 14 consultant. 15 Q. Why was {AOE} lie Lilly getting 16 consultant in to consider this subject? 17 A. [I mean/I'm/I am] not sure, 18 [may be/maybe] to get some ideas [and/on] how to 19 address the question. 20 Q. Okay. . Was {AOE} lie Lilly is 21 getting consultant in to deal with this question 22 because there was a problem with sales of Prozac? 23 A. No. [It's/Its] my 24 understanding it will all resulted from the Page 143 1 publication [that/this a] talked about from 2 {TAOEURB} [err//er] [that/this a] talked about 3 [patience/patients/patient's/patient] [and/on] 4 his experience who were taking Fluoxetine 5 continue had suicide the ideation {STKPWHRAO*E}. 6 Q. Was the Fluoxetine continue 7 cluster formed following {TAOEURB} [err//er] 8 article? 9 A. No . 10 Q. Was [their/there/they're] 11 [a/an] {SWAT} team did you ever [ever/every] 12 [hear/here] [that/this a] phrase formed following 13 {TAOEURB} [err//er] article? 14 A. No, I don't think . 15 Q. Were [their/there/they're] any 16 committees or [groupings/groups] formed 17 specifically in response to {TAOEURB/ERS} 18 article? 19 A. I don't know the Fluoxetine 20 continue cluster was already formed. 21 Q. ? 22 A. [And/On] [so/sew] the 23 Fluoxetine continue cluster {WAPS} 24 [probable/probably] the group that was Page 144 1 responsibility to address the issue. 2 Q. [And/On] there was no separate 3 group {THAFPS} specifically [begun/gun] in order 4 to overlook on respond to [that/this a] issue on 5 to make sure [that/this a] a response to 6 [that/this a] issue was [forth/for the/fourth] 7 coming? 8 A. [Their/There/They're] may have 9 been, there are many sub [groupings/groups] 10 [that/this a] were formed to address particular 11 {KHRAR} aspects of the program. 12 Q. [Down/Do you know] of any such 13 group? 14 A. {SEUPL} sure there was a group 15 that was or [may be/maybe] it was just a person 16 or [2/two] [that/this a] had the 17 [responsibility/responsible] to look at the 18 [spontaneous/spontaneous] reports for suicide. 19 [That's/That he's/That is] all the phone calls 20 [that/this a] come in to screen those or look at 21 these. [And/On] [then/they knew/they know] there 22 was a group, the part of the cluster 23 [that/this a] [knew/new] anything about the 24 [clinically/clinical] trial data base needed to Page 145 1 look at the [clinically/clinical] trial data 2 base. There was a group [that/this a] was formed 3 to address the trials outside the United States. 4 A. In [their/there/they're] 5 [probable/probably] are [mother/more]. 6 Q. Okay. ? 7 ATTORNEY 1: 8 ATTORNEY 1: Take a lunch [brake/break] 9 {STKPWHRAOEUFRPBLGTS}. 10 (A SHORT RECESS WAS TAKEN.) 11 {STKPWHRAOEUFRPBLGTS} 12 ATTORNEY 1: 13 ATTORNEY 1: 14 ATTORNEY 1: 15 ATTORNEY 1: 16 ATTORNEY 1: 17 ATTORNEY 1: [Miss/Ms./Miss] sale 18 [err//er], are you aware if at {SRERT} event 19 regarding Prozac are reported directly 20 [to the/to tell] FDA. 21 MR. GOLDMAN: 22 MR. GOLDMAN: [Buy/By] who. 23 A. [Buy/By] physicians [buy/by] 24 any {WUFRPB}, physicians, people exposed Page 146 1 [to the/to tell] drug. 2 A. {EUPLG} not aware of how 3 [that's/that he's/that is] done. 4 Q. Are you aware whether or not 5 [it's/it is] done being {SEUFRPBLGTSDZ} no, I 6 don't know? 7 Q. You {TKOERPBTS} [know/no], 8 [objecting/okay]? 9 Q. Have you heard of the drug 10 {SPAOERPBTSZ/TPHED} works? 11 A. Yes. 12 Q. Could you describe {KHA} 13 [what/when a] [that is/that's] please? 14 A. [It's/Its] my understanding 15 [it's/its] a data base [that/this a] collect the 16 information [that/this a] we received, Lilly 17 receives from either 18 [patience/patients/patient's/patient] or 19 physicians about any adverse reaction with any 20 Lilly compound. 21 Q. {WAG} this {TKAOEULT} a base 22 used in {-P} formulating the manuscript which 23 described the is it a {STEUSZ} calendar analysis 24 of the [17/seventeen] trials which were pooled? Page 147 1 A. . 2 A. [I mean/I'm/I am] pretty sure 3 it was used as an additional check to make sure 4 any suicide attempt [that/this a] may have been 5 recorded in the DEN data base to make sure 6 [that/this a] it was {KOUPBTSDZ} [had/dollars] in 7 our analysis. 8 Q. Was it across checking, in 9 other words were the names of the subjects put 10 into the DEN data base to determine whether or 11 not [that/this a] subject had made a suicide 12 attempt? 13 A. [I mean/I'm/I am] not sure how 14 that was done. 15 Q. But it was a situation where 16 there was cross checking going [on/and], it was 17 not [and/on] [I mean/I'm/I am] asking you because 18 I don't know the answer, it was not used as an 19 additional dates a base was it? 20 A. Not [for the/forth/fourth] 21 manuscript {STKPWHRAOPL} [so/sew] {AUPL} subjects 22 [that/this a] were part of the manuscript 23 [clinically/clinical] {SKUD} I, were also part of 24 individual [clinically/clinical] trials. Page 148 1 A. Yes. 2 Q. Do you have any idea I 3 [with a/with an] draw [that/this a]? 4 Q. Do you know if president endly 5 there are any [ongoing/on going] studies 6 regarding Prozac [and/on] suicidality? 7 A. . 8 A. Study do you mean [a/an] 9 [actual/actually] [knew/new] 10 [clinically/clinical] trial. 11 Q. {KHRAOEUPBL} trial or 12 preparation of a manuscript? 13 MR. GOLDMAN: 14 MR. GOLDMAN: Wait a minute let me 15 object [to the/to tell] form because 16 [hears/here's/hearsay] {WAOR} we starting to mix 17 the {T-RPLS} study [and/on] [clinically/clinical] 18 trial [and/on] really [what/when a] you got are 19 [2/two] [questions/question is] are 20 [their/there/they're] any [ongoing/on going] 21 [clinically/clinical] trials [on/and] {SEUB}. 22 A. [First/1st] question [and/on] 23 the other one has to do with manuscript [so/sew] 24 [let's/lets] [brake/break] [them/they mean] Page 149 1 [down/do you know]. 2 Q. [I mean/I'm/I am] discussing 3 the broader term of {SKUD} I, the study 4 [concludes/includes] [clinically/clinical] trial 5 {-RBG} preparation of manuscript or any 6 investigation otherwise into Prozac [and/on] 7 suicidality? 8 A. Yes. 9 Q. Okay. [what/when a] are the 10 studies which are presently [ongoing/on going]? 11 A. [It's/Its] still going to 12 complete some of the man {SKREUPTS}. 13 Q. The one [we've/we have] already 14 discussed? 15 A. [And/On] there are 16 [probable/probably] [mother/more]. 17 Q. Are you aware of any 18 [clinically/clinical] trials [that/this a] are 19 [ongoing/on going]? 20 A. No. 21 Q. Are you aware of any 22 {KHRAOEUPBL} trials [that/this a] were conduct 23 {DZ} following the publication of {TAOEURB/ERS} 24 {ARBL} which dealt with suicidality [and/on] Page 150 1 Prozac? 2 A. Yes. 3 Q. How many [clinically/clinical] 4 trials? 5 A. [I mean/I'm/I am] aware of 6 [1/one]. 7 Q. Which is [that/this a] one? 8 A. It was a study that was looking 9 at a particular suicide ideation scale [and/on] 10 the objective was to assess the valid of the 11 scale. 12 Q. [What/When a] scale was 13 [that/this a]? 14 A. [I mean/I'm/I am] not sure 15 [what/when a] the name is. 16 Q. Are you aware of any studies 17 which were conducted specifically to study 18 whether or not suicidal ideation occurred as a 19 result of being exposed to Prozac? 20 MR. GOLDMAN: 21 MR. GOLDMAN: [Buy/By] Lilly. 22 ATTORNEY 1: [Buy/By] an independent 23 investigator. 24 A. No [I mean/I'm/I am] not not Page 151 1 aware of any. 2 Q. Are you aware of any studies 3 conducted [buy/by] [doctor/Dr./Doctor,/Doctor] 4 Donald {KHRAOEUPB} in New York state? 5 A. No [I mean/I'm/I am] not. 6 Q. About the time that you 7 [first/1st] became employed with {AOE} lie Lilly, 8 were you aware of any studies regarding {PROEPZ} 9 [clinically/clinical] experience [and/on] more 10 {TALT} rates? 11 A. No. 12 MR. GOLDMAN: 13 MR. GOLDMAN: Is this at the time she 14 came with the company. 15 ATTORNEY 1: 16 ATTORNEY 1: Yes aren't 1989. 17 A. No. 18 Q. As far as you were concerned 19 within [you are/you're/your] employment at {AOE} 20 lie Lilly, was [their/there/they're] a specific 21 Prozac strategy? 22 MR. GOLDMAN: [I object/I be] 23 [to the/to tell] form of the question [and/on] 24 use of the term Prozac {STRAT/TKPWEU} as being Page 152 1 over broad [and/on] otherwise vague [and/on] 2 undefined, you can answer if you can. 3 A. No [I mean/I'm/I am] not aware 4 of any specific {STRAT/TKPWEU}. 5 Q. {STKPWHRAOEUFRPBLGTS}? 6 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 7 MARKED FOR IDENTIFICATION AND 8 RECEIVED IN EVIDENCE.) 9 {STKPWHRAOEUFRPBLGTS} 10 ATTORNEY 1: 11 ATTORNEY 1: 12 Q. [I have/I've] now shown you 13 [plaintiff's/plaintiffs] exhibit b 14 [is that/is this a] you [you are/you're/your] 15 handwriting in the upper right-hand corner? 16 A. I think . 17 Q. Does [that/this a] say Prozac 18 stat {TKPWREU}? 19 A. Yes. 20 Q. [What/When a] did you 21 [mean/me know] [buy/by] [that/this a]? 22 A. [There is/There's/Theirs] a 23 meeting that's referred to as a Prozac {STRAT} 24 {TKPWEU} meeting [and/on] this is my folder where Page 153 1 I kept notes from [that/this a] meeting. 2 Q. Was [their/there/they're] 3 [1/one] meeting or was [their/there/they're] 4 after {SAOER} wrist [a/an] of meetings? 5 A. [A/An] {SAOER} wrist of 6 meetings. 7 Q. [And/On] was Prozac was quote 8 Prozac {STRAT/TKPWEU} unquote discussed at 9 [that/this a], at those meetings? 10 A. Yes, [it's/its] definitely 11 Prozac related topics [that/this a] were excused 12 at [that/this a] meeting. 13 Q. [I mean/I'm/I am] asking you 14 specifically was [their/there/they're] Prozac 15 {STRAT/TKPWEU}? 16 A. Whether a do you mean [buy/by] 17 {STRAT/TKPWEU}. 18 Q. I just got the word from 19 [you are/you're/your] folder I thought 20 [may be/maybe] [you would/you'd] [know/no]? 21 A. It was the name of 22 [meat/meet/me the]. 23 Q. [So/Sew] it was a name of the 24 meeting? Page 154 1 A. Yes. 2 Q. But just to make it clear, as 3 far as you know [you are/you're/your] not aware 4 of any Prozac strategy? 5 MR. GOLDMAN: 6 MR. GOLDMAN: 7 [That's/That he's/That is] [what/when a] she 8 recall answered to your question, 9 [she is/she's/she say] asked [and/on] answered. 10 Q. You can answer? 11 A. [Anyone/Any one] specific 12 {STRAT/TKPWEU}, I still {TKOEPBLTSD} 13 understand. 14 Q. All [I mean/I'm/I am] asking is 15 if [you are/you're/your] aware of 16 [anyone/any one] specific {STRAT/TKPWEU}? 17 A. No, the 18 [tomorrow/topple/to my/to me] {EUBGS} discussed 19 at this meeting, [it's/it is/its] [mother/more] 20 of [a/an] {PRAOEURT} type meeting. 21 A. Discuss [what's/what is] pry 22 mortgage {*R} or the [and/on] I don't know if 23 that would be considered [a/an] {STRAT/TKPWEU} 24 or not. Page 155 1 Q. You mean to discuss 2 [what's/what is] {PRAOEURT} for [that/this a] 3 particular month or for [that/this a] particular 4 time to do in regard to Prozac? 5 A. Yes. 6 Q. Do you recall what was pry or 7 the say in 1990? 8 A. I don't know, I didn't go to 9 too many of these meetings. 10 Q. Who went to those meetings? 11 A. Mostly research physicians 12 [and/on] [representive/representatives] from most 13 areas of the cluster [and/on] I was representing 14 is it a {TEUS} sticks in some cases but I did not 15 regularly a tend. 16 Q. {STKPWHRAOS} [what's/what is] a 17 met an analysis? 18 A. [It's/Its] analysis 19 [that/this a] {KPWAOEUPBS} data from different 20 studies. 21 Q. [So/Sew] [it's/its] basically 22 [what/when a] [we have been/we've been] 23 discussing? 24 A. Yes. Page 156 1 Q. During this deposition? 2 A. Yes. 3 Q. Do you know what a package 4 [in/inch/I know/I knew] {SERTD} is? 5 A. Yes. 6 Q. [And/On] would you say 7 [that/this a] package inserts contain a portion 8 which is entitled adverse reactions? 9 MR. GOLDMAN: [This is/This is] [a/an] 10 [generally/general] proposition, not proud {UBGS} 11 specific. 12 A. [Generally/General] 13 proposition. 14 Q. [What's/what is]? 15 A. [What's/What is] the question. 16 Q. Do package inserts contain a 17 portion sub titled adverse reactions? 18 A. I think . 19 Q. Do the {STALT/STEUGS} [is/\S] 20 as [a/an] [generally/general] proposition 21 contribute information [to the/to tell] total 22 information [that is/that's] [on/and] a package 23 insert? 24 MR. GOLDMAN: Page 157 1 MR. GOLDMAN: [What/When a] do you mean 2 let me object [to the/to tell] form, you used 3 total information. 4 Q. [I mean/I'm/I am] the total 5 information on the package 6 [in/inch/I know/I knew] {SERTD}, is some of 7 [that/this a] derived from the work [that/this a] 8 stat {STEUGS} [is/\S] do? 9 A. In some cases, 10 [probable/probably]. 11 Q. Are you aware whether or not 12 the is it a {TEUS} sticks department [ever/every] 13 created a table which listed adverse reactions of 14 Prozac [and/on] certain percentages or problem 15 abilities of the occurrence? 16 MR. GOLDMAN: 17 MR. GOLDMAN: Let {HAOE} object 18 [to the/to tell] form only [to the/to tell] 19 extent use of the term reaction implies causality 20 {SEUFRPBLGTS}. 21 MR. GOLDMAN: I think 22 [he's/he is/he say] ask if [you are/you're/your] 23 aware whether is it a {TEUS} sticks [ever/every] 24 prepared the kind of table [he's/he is/he say] Page 158 1 talking about. 2 A. {EUBLDZ} for some copy pound, 3 yes the stat {STEUGS} may have prepared 4 [that/this a]. 5 Q. {TKAO} a stat {STEUGS} do 6 [that/this a] for Prozac? 7 A. I don't know. 8 Q. {O}? 9 Q. {TKUFRL} work [on/and] that 10 many issue in regard to Prozac, in other words 11 the issue of side [affects/effects], separating 12 [them/they mean] [buy/by] name [and/on] figuring 13 out the chance or probability of occurrence? 14 A. . 15 Q. Following exposure to Prozac? 16 A. Yes. 17 Q. [And/On] could you describe 18 exactly [what/when a] you did in [that/this a] 19 {RARBD}? 20 A. [Their/There/They're] were a 21 couple of reports I worked [on/and] [that/this a] 22 were interested in some very specific events 23 [and/on] I may have produced some reports with 24 [that/this a] sub [set/is he the] of events Page 159 1 although it may not have been me, 2 [I mean/I'm/I am] not sure. 3 Q. [What/When a] events did you 4 work with? 5 A. I worked [on/and] one report 6 that was interested in focusing [on/and] bleeding 7 related events [and/on] another report focused 8 [and/on] {PUPLT} narrow related events. 9 Q. Do you agree with 10 [you are/you're/your] counsel [that/this a] 11 adverse reactions implies causality? 12 A. In some people's mine, I would 13 say yes. 14 Q. [What/When a] about in 15 [you are/you're/your] mind? 16 A. No. 17 Q. [What's/What is] [add/ad] 18 version reaction [mean/me know] to you? 19 A. It was a condition 20 [that/this a] occurred {TPHPT} patient. 21 Q. [It's/Its] an adverse reaction 22 different than an adverse events? 23 MR. GOLDMAN: 24 MR. GOLDMAN: [Well/Well,] before she Page 160 1 answer let me object [to the/to tell] form 2 [to the/to tell] extent it [may/May] call upon 3 her to render medical opinion, if she can 4 discontinue {TKPWEURB} or differentiate as [a/an] 5 [late/lathe] person, [that's/that he's/that is] 6 fine. 7 A. Those [2/two] terms may have 8 discontinuing definition in it but I don't know 9 [what/when a] [they would/they'd] be. Do me they 10 [mean/me know] the same. 11 Q. Now the study that you were 12 involved in, where you studied bleeding, 13 [is that/is this a] where the adverse event was 14 listed on the c r f as bleeding [and/on] you 15 looked at all of those or exactly what happened, 16 what was the mechanism? 17 A. The a research physician looked 18 at all the event [and/on] cat {TKPWOR} 19 [rise/rice] [had/dollars] which event could 20 relate to bleeding. 21 Q. [And/On] bleeding is a very 22 broad term is it the not? 23 A. [It's/Its] a broad term. 24 Q. Is he bleeding could be if Page 161 1 somebody fell down while [on/and] Prozac [and/on] 2 [can you tell/cut] [their/there/they're] knee? 3 A. That's right. 4 Q. [And/On] bleeding could also be 5 somebody [accidents/accident]ly put 6 [their/there/they're] hand [threw/through] a 7 window? 8 A. That's right. 9 Q. [And/On] bleeding could also be 10 if somebody {SHREUT} [their/there/they're] wrist, 11 is that right? 12 A. [It's/Its] possible. 13 Q. Well, [is that/is this a] since 14 you did this study, do you know whether or not if 15 somebody {SHREUT} [their/there/they're] wrist 16 would be considered a bleeding event? 17 A. I didn't do the study, the 18 investigator records the event. 19 Q. [So/Sew] [what/when a] exactly 20 did you do in regard to [that/this a] study? 21 A. [Ones/Once] the research 22 physician at Lilly determined which event would 23 be considered bleed {LG} event 24 [then/they knew/they know] a systems analyst Page 162 1 combined those events [and/on] created [a/an] 2 {SRAEUR/ABL} for [that/this a] can be used as 3 yes [know/no] for [that/this a] {PAEURB}, whether 4 or not {ARP} patient had a bleeding event 5 [and/on] I used [that/this a] data to run [a/an] 6 {TPHAL} season looking at the occurrence of 7 bleeding events between treatment 8 [groupings/groups]. 9 Q. Okay. [what/when a] did you 10 finds? 11 A. [What/When a] did I finds. 12 Q. Yes? 13 A. . 14 MR. GOLDMAN: 15 MR. GOLDMAN: [I object/I be]. 16 A. There are a number of analyses. 17 Q. ? 18 MR. GOLDMAN: 19 MR. GOLDMAN: Let me object 20 [to the/to tell] formats overly broad in asking 21 her to recite the complete results of some 22 analyses [that/this a] she did. 23 Q. Did you fine there was a great 24 variance between different studies, between Page 163 1 different [clinically/clinical] trials? 2 A. . 3 A. Great variance of 4 [what/when a]. 5 Q. Of incidents of bleeding, 6 bleeding events? 7 A. I don't recall. 8 Q. {STKPWHRAOEUFRPBLGTS}? 9 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 10 MARKED FOR IDENTIFICATION AND 11 RECEIVED IN EVIDENCE.) 12 {STKPWHRAOEUFRPBLGTS} 13 ATTORNEY 1: 14 ATTORNEY 1: Larry this is a document 15 that was produced in the [course/coarse] of the 16 MDL litigation. 17 MR. GOLDMAN: 18 MR. GOLDMAN: [Right/Write] 19 [that's/that he's/that is] the one you [and/on] I 20 correspondence [had/dollars] about at least 21 [2/two] or [3/three] times. 22 ATTORNEY 1: 23 ATTORNEY 1: [Right/write]. 24 Q. [Miss/Ms./Miss] sale [err//er], Page 164 1 now [that/this a] [you have/you've] [scene/seen] 2 exhibit [3/three], do you know what this document 3 is? 4 A. [I mean/I'm/I am] pretty sure 5 [it's/its] the package insert. 6 Q. Okay. . If you look at page 7 [10/ten] of the document, just 8 [understands/under] the heading adverse reaction, 9 we go over [to the/to tell] [next/necks] page, 10 [eleven/11], you see {THAP} table 11 [their/there/they're]? 12 A. Uh-huh, yes. 13 Q. Did the is it a {TEUS} sticks 14 department help to create [that/this a] table? 15 A. I don't know. 16 Q. Is this table with the 17 [numb/number] or the letter {TPHFPLT/AOE} 18 equals [1/one] thousand seven hundred 19 [30/thirty], in {AOE} equals 79 [9/nine] [and/on] 20 considering [that/this a] it has certain 21 mathematical indications on it, does it look like 22 something [that/this a] is it a {TEUS} sticks 23 department would create? 24 A. It would be it would either be Page 165 1 the systems analyst or a stat {STEUGS}. 2 Q. If the [system/stem] analyst 3 were to create such {AP} table, 4 [how old/how would] they come up with the 5 [numbers/numbs] as listed? 6 MR. GOLDMAN: 7 MR. GOLDMAN: Let me object 8 [to the/to tell] form. 9 ATTORNEY 1: 10 ATTORNEY 1: [Fun/if you know]. 11 Q. ? 12 MR. GOLDMAN: 13 MR. GOLDMAN: [Objecting/Okay] 14 [fun/if you know]. 15 A. They are [cable/capable] had 16 [rung/running/wrung] {AL} program that would 17 obtain these [numbers/numbs] of 18 [patience/patients/patient's/patient]. 19 Q. [That will/That'll] {PRAOEG} 20 would come from this stat I say {STEUGS} [is/\S] 21 wouldn't it? 22 A. No not necessarily. 23 Q. Okay. . 24 Q. [We are/We're] still {UBD} Page 166 1 [understands/under] the same heading [and/on] if 2 [you would/you'd] go over to page [14/fourteen], 3 on the bottom, the bottom paragraph where it says 4 body as [a whole/a hold/a hole] [and/on] it seems 5 frequent [injure/injury] accident [and/on] 6 surgical procedure in large letters. Do you know 7 what [that/this a] means if [it's/its] written in 8 large letters? 9 A. No, I don't. 10 Q. Do you know what it means if 11 [there is/there's/theirs] a line 12 [through the/threw the] large letters? 13 A. No, I don't. 14 Q. [And/On] if we read further 15 where it says infrequent [and/on] it says 16 intentional overdose {S-RBGS} do you know whether 17 or not [that/this a] intentional overdose phrase 18 is [included/concluded] within the Lilly 19 definition of suicide? 20 MR. GOLDMAN: 21 MR. GOLDMAN: Let me object 22 [to the/to tell] form of the question 23 [to the/to tell] extent it assumes 24 [there is/there's/theirs] a quote unquote Lilly Page 167 1 definition of suicide. 2 Q. [Well/Well,] I don't have? 3 MR. GOLDMAN: 4 MR. GOLDMAN: I don't know 5 [that/this a] [there is/there's/theirs] been any 6 such testimony. 7 ATTORNEY 1: 8 ATTORNEY 1: I don't have the exact 9 [erection/erects/recollection] of [what/when a] 10 you said but I believe you said attempted suicide 11 was when there was any {TKAEUPBG} [err//er] of 12 self harm. 13 A. True. 14 Q. Is that right? 15 A. That's right. 16 Q. Is intentional overdose 17 considered an attempted suicide? 18 MR. GOLDMAN: 19 MR. GOLDMAN: [I object/I be] 20 [to the/to tell] form, do you mean in the same 21 context she earlier discussed when they were 22 counting events [forth/for the/fourth] {PURPBS} 23 was the analysis. 24 Q. [I mean/I'm/I am] in relation Page 168 1 to the document [that/this a] [we've/we have] 2 before [us/you say] is intentional overdose 3 considered attempted suicide? 4 A. In this document. 5 Q. Yes? 6 A. {KHREPL/KHREPL/KHREPL} 7 {KHREPL/KHREPL} before she answered 8 [that/this a] [I mean/I'm/I am] going to object 9 [I mean/I'm/I am] sure this is already been said 10 [ones/once] before she said she didn't prepare 11 [that/this a] document [and/on] if 12 [she know/she knew] [that/this a], 13 [then/they knew/they know] she could 14 [probable/probably] comments on it obviously 15 [I mean/I'm/I am] not her [attorney/torn], I 16 can't [you know/you knew/you know,] 17 [I mean/I'm/I am] going to object 18 [ford/forward/for the record] just 19 [forth/for the/fourth] [that/this a] statement 20 [alone/a loan]. 21 MR. GOLDMAN: 22 MR. GOLDMAN: [Fun/If you know] the 23 answer to the question, {TPW} you {TKOEUPBTSD} 24 [know/no] tell him [that/this a]. Page 169 1 A. The question is not in a form 2 [in/inch/I know/I knew] how to answer. 3 Q. Okay. on the [next/necks] line 4 [below/blow], where just uses the words 5 overdose,? 6 A. Yes. 7 Q. [Down/Do you know] whether 8 [that/this a] [concludes/includes] 9 [accidents/accident] will overdose for instance 10 somebody [red/read] the directions [on/and] a 11 label [in/inch/I know/I knew] correctly or they 12 misunderstood the prescriptions? 13 MR. GOLDMAN: 14 MR. GOLDMAN: [I object/I be] 15 [to the/to tell] form [she is not/she's not] the 16 writer of the document. [You are/You're/Your] 17 calling upon her to interpret {PRETD} this in 18 this con {TKEBGS} [what/when a] [that/this a] 19 means [and/on] she didn't write it. 20 Q. ? 21 ATTORNEY 1: 22 ATTORNEY 1: [Down/Do you know] 23 [Mr./Mister] my [err//er] when [weak/week/we can] 24 depose the writer of this document. Page 170 1 MR. GOLDMAN: {SKWRAOEUPL} not 2 [understands/under] examination [Mr./Mister] 3 Green ask the witness another question. 4 ATTORNEY 1: 5 ATTORNEY 1: [I would/I'd] 6 [ford/forward/for the record] ask [that/this a] 7 the writer of the document be produced for a 8 deposition [sentence/as soon as] possible. 9 Q. On the [next/necks] page, page 10 [15/fifteen], the second line do you know where 11 it says suicide attempt, [know/no] drug used, do 12 you know what [that/this a] means? 13 MR. GOLDMAN: 14 MR. GOLDMAN: Same 15 [objection/ox/oxygen]. 16 A. No. 17 Q. Do you think [that/this a] the 18 phrase [hear/here] suicide attempt means 19 something different than [what/when a] we 20 originally discussed earlier in this deposition? 21 MR. GOLDMAN: 22 MR. GOLDMAN: Same 23 [objection/ox/oxygen] [you are/you're/your] 24 asking her to comments [on/and] [a/an] or equate Page 171 1 or not {AOE/KWAEUTD} [what/when a] you earlier 2 talked about in the context of re[and/on] lies 3 [go/\ing] some data with [what's/what is] 4 [on/and] a document [that/this a] she did not 5 write [and/on] [and/on] that would call upon her 6 to speculate [what/when a] it {TPHAOEPBS} this 7 document, she earlier told you [what/when a] she 8 under stood in the context of the reanalysis. 9 Q. When the adverse reactions are 10 {KWREUT} [he know/he knew/EN\] according to body 11 [system/stem] if you {HRAOBLG} at this, it says 12 body as [a whole/a hold/a hole], cardiovascular, 13 [die/dye] jest [I have/I've], [etc./et cetera],? 14 Q. Does the writer of the package 15 insert inter {ARBGT} with the is it a {TEUS} 16 {SKAL}, with the is it a {TEUS} sticks department 17 in other words to determine or to help to 18 determine which adverse reactions to list, for 19 instance how did the writer of this document come 20 up with for body as [a whole/a hold/a hole] 21 {TPHREBGT}, {KHEULS}, [injure/injury] accident, 22 surgical procedure? 23 MR. GOLDMAN: 24 MR. GOLDMAN: [I object/I be] Page 172 1 [to the/to tell] form, [2/two] it calls upon her 2 to speculate as to how [hover/whoever] wrote this 3 came up with any of the terms [that/this a] are 4 in [hear/here]. 5 Q. Did [whoever/however] 6 [right/write] this, do you know who wrote this by 7 the way? 8 A. No, I don't. 9 Q. Do you know what department 10 wrote this? 11 A. No, I don't. 12 Q. [Down/Do you know] January pot 13 {SREUPB}? 14 A. Yes, I do. 15 Q. Does she write package inserts? 16 A. The not sure. 17 Q. Has she ever written anything 18 like this [wherein/where in] [she would/she'd] 19 list the body [system/stem] [and/on] the [add/ad] 20 {SRERTS} reactions associates {WD} [that/this a] 21 body [system/stem]? 22 A. As the original author or as an 23 editing. 24 Q. As [a/an] [add/ad] editor? Page 173 1 A. [Probable/probably], I don't 2 know for sure. 3 Q. Do you think January pot 4 {SROPB} [knows/nose/no, sir] who the original 5 author is? 6 MR. GOLDMAN: 7 MR. GOLDMAN: [I object/I be] 8 [to the/to tell] form I don't know if she can 9 comments [on/and] [what/when a] January pot 10 {SREUPB} [knows/nose/no, sir] or don't know. 11 Q. She [knows/nose/no, sir] 12 [what/when a] position January pot {SREUPB} has 13 January spot {SRPB} [he had/he'd] 14 [it's/it is/its] [things/thinks], [right/write]? 15 A. [It's/Its] one of her function 16 {STKPWAS} what she edits documents does 17 [she know/she knew] who writes [them/they mean]. 18 A. I assume [so/sew]. 19 Q. I was [wandering/wondering] if 20 that was kept secret within the organ sakes, the 21 Lilly organization? 22 MR. GOLDMAN: [What/when a]. 23 ATTORNEY 1: 24 ATTORNEY 1: Who the author of the Page 174 1 document is whisk edited at the time. 2 A. No that's not kept secret. 3 Q. Did anybody who wrote anything 4 like this [and/on] I believe not saying it has to 5 be a package insert, [I mean/I'm/I am] just 6 saying was set up in a similar format [and/on] it 7 had to do with Prozac where they listed the 8 [add/ad] {SREURS} reactions [buy/by] body 9 {STOEPL}, [ever/every] [that/this a] 10 [you are/you're/your] aware of [ever/every] come 11 to the is it a {TEUS} sticks department to 12 determine which adverse reactions to 13 [clued/include/conclude]? 14 A. [May be/Maybe] it would be in 15 [addition/edition] to systems analyst. 16 Q. Okay. [so/sew] [hover/whoever] 17 was writing such a document would either go to 18 the is it a {TEUS} sticks or systems analyst is 19 that right? 20 MR. GOLDMAN: 21 MR. GOLDMAN: Let me object 22 [to the/to tell] form, she said [may be/maybe]. 23 Q. Okay. this is a different 24 question now? Page 175 1 Q. Would [hover/whoever] {WAOS} 2 writing such a document get the information 3 either from the is it a from the systems analyst 4 or the is it a {TEUS} sticks department? 5 MR. GOLDMAN: 6 MR. GOLDMAN: [I object/I be] 7 [to the/to tell] form it [miss/Ms./Miss] 8 character rises her earlier testimony [and/on] 9 calls upon her to speculate as to [what/when a] 10 some unknown or [you know/you knew/you know,] 11 [defines/defined] person would do or not do. 12 ATTORNEY 1: 13 ATTORNEY 1: [I mean/I'm/I am] not 14 character rising anything you said, 15 [I mean/I'm/I am] ask a question. 16 Q. If somebody at {AOE} lie Lilly 17 wanted to write something set up like this, 18 [a/an] [system/stem] [buy/by] [system/stem] 19 listing of adverse reactions, where would they 20 get the information from? 21 MR. GOLDMAN: 22 MR. GOLDMAN: Same 23 [objection/ox/oxygen] [fun/if you know] tell 24 [them/they mean] if you don't [know/no] tell Page 176 1 [them/they mean] [that/this a]. 2 A. If [it's/it is/its] a for 3 [a/an] {KHRAOEUPBL} trial if [it's/it is/its] 4 based [on/and] {KHRAOEUPBL} trial data, 5 [I would/I'd] say [that/this a] 6 [they would/they'd] most likely go to a systems 7 analyst or stat {STEUGS}, [I mean/I'm/I am] not 8 aware of any other [way/weigh] they could get the 9 information. 10 Q. Okay. . 11 Q. Well, in your manuscript that 12 was a pooling of the [17/seventeen] trials, were 13 adverse reactions discussed in [that/this a] 14 manuscript? 15 A. I [refer/referrer] to 16 [them/they mean] as adverse events, yes. If they 17 [mean/me know] the same to me. 18 Q. [Objecting/Okay] [well/well,] 19 [fun/if you know] [them/they mean] as adverse 20 event [and/on] this says adverse reaction on it 21 [may be/maybe] we better just stick to 22 [that/this a]. {STKPWHRAOEUFRPBLGTS} 23 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 24 MARKED FOR IDENTIFICATION AND Page 177 1 RECEIVED IN EVIDENCE.) 2 {STKPWHRAOEUFRPBLGTS} 3 ATTORNEY 1: 4 ATTORNEY 1: 5 ATTORNEY 1: 6 Q. [Miss/Ms./Miss] sale [err//er], 7 [you have/you've] now reviewed 8 [plaintiff's/plaintiffs] exhibit [47/forty-seven] 9 is that correct? 10 A. Yes. 11 Q. {TKOUPBG} what this document 12 is? 13 A. No, I don't. 14 Q. Have you ever [scene/seen] this 15 document before? 16 A. Not [that/this a] 17 [I can/I could] remember. 18 Q. If I told you [that/this a] 19 this document was produced from at least 20 according too [you are/you're/your] attorneys 21 from [you are/you're/your] files, would 22 [that/this a] refresh your 23 [erection/erects/recollection]? 24 A. It might help if Page 178 1 [in/inch/I know/I knew] [what/when a] part of my 2 files. 3 Q. It would [probable/probably] 4 help [us/you say] too but 5 [that's/that he's/that is] why [I have/I've] to 6 ask you [questions/question is]. 7 A. I don't know. 8 Q. You [doesn't/don't] recognize 9 it at all? 10 A. (Witness moves head from side 11 to side.). 12 Q. [I would/I'd] {*R} 13 [I would/I'd] like to speak [generally/general] 14 for a while. If you can describe to me the 15 purpose [and/on] use of {PHATD} [math/mat] 16 calendar formulas within [you are/you're/your] 17 [role/roll] as a stat {STEUGS}? 18 MR. GOLDMAN: 19 MR. GOLDMAN: [Is that/Is this a] a 20 question or [is that/is this a] the topics. 21 ATTORNEY 1: 22 ATTORNEY 1: [That's/That he's/That is] 23 the topics. 24 Q. [Know/No] [I would/I'd] like Page 179 1 you to [generally/general] describing the use of 2 mathematical formulas? 3 MR. GOLDMAN: 4 MR. GOLDMAN: Before {HAOE} answer, 5 [I object/I be] [to the/to tell] form because 6 [it's/its] over broad [and/on] [ones/once] 7 [it's/its] something she could 8 [probable/probably] give a short seminar [on/and] 9 [what/when a] do you wanted [to know/ton]. 10 Q. [What/When a] I wants 11 [to know/ton] is [you know/you knew/you know,] a 12 lot of people might not even [know/no] whether or 13 not you use formula, they might think you just 14 divide one [numb/number] [buy/by] another which 15 is a formula I guess but they might think 16 [it's/its] [that/this a] simple, you divide one 17 name [buy/by] another [numb/number] to get a 18 percentage [is that/is this a] all you do as stat 19 {STEUGS}? 20 A. No. 21 Q. Could you describe [a/an] 22 [bit/by the] [mother/more] [what/when a] you do 23 as far as the use of formulas goes? 24 MR. GOLDMAN: Page 180 1 MR. GOLDMAN: Same 2 [objection/ox/oxygen] see if you can give him 3 some sort of {SKWREBLG} description about use of 4 mathematical formulas as stat {STEUGS}. 5 A. All the is it a {TEUS/SKAL} 6 tests [and/on] [medical/med] {THDZ} are based 7 [on/and] mathematics or most of [them/they mean]. 8 Q. Are the formulas something 9 which are developed specifically for a certain 10 test or are they formulas [that/this a] are used 11 throughout the profession of is it a {TEUS} 12 sticks? 13 A. . 14 Q. In other words? 15 A. There are many farm last 16 [that/this a] are used throughout all the 17 professional is it a {TEU} sticks 18 [whoever/however] [it's/it is/its] [a/an] 19 [knew/new] field [and/on] 20 [there is/there's/theirs] a lots of continuing 21 research [so/sew] there are [knew/new] formulas 22 being used. 23 Q. Now did you use formulas when 24 you derived or when you performed the is it a Page 181 1 {TEUS/SKAL} analysis which eventually became 2 the man {AOU} script [that/this a] 3 [we have been/we've been] discussing? 4 A. Indirectly, yes. 5 Q. [What/When a] do you mean 6 indirectly {SEUFRPBLGTS} Wheadon computer 7 software [that/this a] [actual/actually] has a 8 lot of the formulas built in [and/on] we just 9 need [to know/ton] how to use the software? 10 Q. Now,? 11 A. [And/On] there are some cases 12 we did do our own computer, our computerize 13 [go/\ing] our own formulas, yes. 14 Q. Okay. ? 15 Q. This is 16 [plaintiff's/plaintiffs] exhibit [5/five] 17 [and/on] I believe going to [leave/leaf] {TOBS} 18 [and/on] just because there are some formulas 19 which are tab [had/dollars]? 20 A. Okay . 21 Q. I {WAPT} the to talk about 22 [that/this a] {STKPWHRAOEUFRPBLGTS}? 23 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 24 MARKED FOR IDENTIFICATION AND Page 182 1 RECEIVED IN EVIDENCE.) 2 [5/five], [5/five], {STKPWHRAOEUFRPBLGTS} 3 {-GSZ}. 4 Q. Motion stale [err//er] have you 5 reviewed this exhibit? 6 A. Yes. 7 Q. Do you know what [it's/it is]? 8 A. . 9 A. [I mean/I'm/I am] not sure of 10 the source of it, I think [in/inch/I know/I knew] 11 [what/when a] [it's/it is]. 12 Q. [What/When a] do you think it 13 might be? 14 A. It may have been slides for an 15 internal presentation. 16 Q. An internal presentation does 17 that mean to other Lilly [employee's/employees]? 18 A. Yes. 19 Q. If you go [to the/to tell] 20 [first/1st] to be where [it's/its] [a/an] yellow 21 tab, see [that/this a] form will 22 [their/there/they're]? 23 A. Yes. 24 Q. [What's/What is] [that/this a] Page 183 1 formula being used for? 2 MR. GOLDMAN: 3 MR. GOLDMAN: [Generally/General] or in 4 this context [on/and] this page. 5 ATTORNEY 1: 6 ATTORNEY 1: In this con {TEBLGS} 7 [on/and] this page. 8 A. This shows how the {KOBG} man 9 {HAPB} [sell/cell] test is computed. 10 Q. [Is that/Is this a] a formula 11 [that's/that he's/that is] used {TPHOERT} 12 situation [is/\S], [north/nor the] tests in our 13 {KWPS}? 14 A. Yes. 15 Q. Does [that/this a] formula have 16 a name? 17 A. The could are man {AL/HAPB} 18 [sell/cell] test {STKPWHRAOEUFRPBLGTS/KROBG} 19 {RAOPB} man tell {HAPB} [sell/cell]. 20 MS. LAWS: Laws [I'd/eyed/identify] the 21 page when [you are/you're/your] talking something 22 [so/sew]. 23 MR. GOLDMAN: 24 MR. GOLDMAN: This is page p z Page 184 1 [14/fourteen] [seventy-two/'72], 2 [23/twenty-three] [thirty-three/33]. 3 Q. Would there ever been another 4 formula that you [cough/could have] used in 5 [place/plays] of [that/this a] formula to 6 {PHREUBG} the same job? 7 A. Not that I am aware of. 8 Q. ? 9 Q. How many {SRAEUR/KWRABLS} 10 does [that/this a] formula have in it? 11 A. How many {SRAEUR/RABLS}. 12 Q. [I mean/I'm/I am] 13 [x/examine/exam] [numbers/numbs], [numbers/numbs] 14 where [you had/you'd] to plug in [numbers/numbs] 15 in order to get [you are/you're/your] answer? 16 A. I don't know, the computer 17 would do [that/this a]. 18 Q. [Well/Well,] now 19 [that's/that he's/that is] [you are/you're/your] 20 hands writing isn't it? 21 A. No. 22 A. [I mean/I'm/I am] pretty sure 23 that's not my handwriting. 24 Q. Okay. . Can we go Page 185 1 [to the/to tell] [next/necks] one many [it's/its] 2 the [next/necks] tab? 3 MR. GOLDMAN: 4 MR. GOLDMAN: These p z [14/fourteen] 5 [seventy-two/'72], [23/twenty-three] 6 [35/thirty-five] {STKPWRAO}. 7 Q. [Is that/Is this a] 8 [you are/you're/your] handwriting 9 [their/there/they're]? 10 A. No. 11 Q. Okay. . If [you would/you'd] 12 just look at all tab [had/dollars] formula 13 [and/on] tell me if any of [them/they mean] are 14 [you are/you're/your] handwriting, I would 15 {PRAOERBL} [that/this a]? 16 A. No. 17 Q. Okay. now, isn't it part of 18 the job of the stat {STEUGS} [ones/once] 19 [you know/you knew/you know,] which formula 20 [you have/you've] to use, to obtain the 21 [numbers/numbs] to plug into [that/this a] 22 formula? 23 A. Our job is to write a computer 24 program such [that/this a] the write Page 186 1 [numbers/numbs] are used for the computation of 2 these tests. 3 Q. [So/Sew] did you write such a 4 program in relation to the manuscript? 5 A. I wrote some programs for the 6 man {SKWREUP}, yes. 7 Q. [And/On] [what/when a] were 8 those programs, how many did you write? 9 A. . 10 A. I don't know [15/fifteen], 11 [may be/maybe]. 12 Q. Was the purpose of any of 13 {THOELS} programs to value suicidality in 14 {PROEUZ} or any aspect thereof? 15 A. Yes. 16 Q. How many of the [15/fifteen] 17 programs were for [that/this a] purpose? 18 A. All of [them/they mean]. 19 Q. ? 20 A. [And/On] some since. 21 Q. Okay. are 22 [their/there/they're] some programs [that/this a] 23 were [mother/more] directly related to 24 [that/this a] than others? Page 187 1 A. Yes. 2 Q. Okay. could you describe one 3 of those programs that was directly related to 4 [that/this a]? 5 A. . 6 Q. ? 7 MR. GOLDMAN: 8 MR. GOLDMAN: 9 MR. GOLDMAN: [And/On] [buy/by] that 10 you generically [mean/me know] the suicidality 11 analysis. 12 ATTORNEY 1: 13 ATTORNEY 1: Yes. 14 A. Yes, I am pretty sure 15 [I have/I've] a program [that/this a] will 16 {KOUPBLTS} the [numb/number] [that will/that'll] 17 {AOE/TPHAOUPL} rate the [numb/number] of 18 [patience/patients/patient's/patient] 19 [who'd/who had] a zero or [1/one] at base line 20 [and/on] Ham-D item [3/three] [and/on] increased 21 to [a/an] [3/three] or [4/four]. And the program 22 was written to be able to counsel those 23 [numb/number] of 24 [patience/patients/patient's/patient] to Page 188 1 calculate the proportions [and/on] run the is it 2 a {TEUS/SKAL} tests. 3 Q. Okay. . When {TPHP} counting 4 the [numb/number] of 5 [patience/patients/patient's/patient], does the 6 computer do [that/this a] [buy/by] reviewing the 7 ham {STKFPLT} scales? 8 A. All the Ham-D item {SKOERS} are 9 computerized [and/on] yes the program will review 10 [that/this a]. 11 Q. [So/Sew] was the [first/1st] 12 part of [you are/you're/your] program to search 13 the Ham-D scales? 14 A. Yes. 15 Q. For 16 [patience/patients/patient's/patient] 17 [that/this a] started with the Ham-D [3/three] 18 rating of zero to [1/one]? 19 A. Yes. 20 Q. [And/On] 21 [then/they knew/they know] did the program go 22 [on/and] to determine which of those 23 [groupings/groups] of people ended up with [a/an] 24 Ham-D [3/three] rating of [3/three] to [4/four]? Page 189 1 A. Yes. 2 Q. [And/On] 3 [then/they knew/they know] was the computer 4 program designed to give you a number, in other 5 words, it counted how many people went from zero 6 to one to [3/three] to [4/four]? 7 A. Yes. 8 Q. Do you recall [what/when a] 9 [that/this a] [numb/number] was? 10 A. No, I don't recall. 11 Q. Do you recall whether 12 [nip/in my opinion] subjects [who'd/who had] been 13 exposed to placebo went from zero to one to 14 [3/three] to [4/four]? 15 A. Yes. 16 Q. [And/On] [what's/what is] the 17 answer to [that/this a], did they? 18 A. Yes, they did. 19 Q. Okay. . How did you know 20 whether present time subject had been exposed to 21 a placebo or Prozac? 22 A. [That's/That he's/That is] also 23 {STOERTD} in the computer. 24 Q. Okay. [so/sew] was part of Page 190 1 [you are/you're/your] program 2 [then/they knew/they know] to give you various is 3 it a {TEUS/SKAL} results such as the 4 [numb/number] of subjects exposed to Prozac who 5 went from zero, [1/one] to [3/three], [4/four], 6 the [numb/number] of {SEURBTS} exposed to {PHRA} 7 {SAOEB/PWOE} went from zero [1/one], to 8 [3/three], [4/four], [etc./et cetera]? 9 A. Yes. 10 Q. Did [that/this a] computer 11 program encompass this formula which 12 [you have/you've] before you? 13 A. Which formula. 14 Q. This one [right/write] 15 [hear/here], this one [right/write] [hear/here], 16 where p z, [on/and] page p z [1/one] [4/four] 17 [seventy-two/'72], [2/two] [thirty-three/33] 18 [5/five] [and/on] [it's/its] [tell us/the] one 19 where I asked you if [that's/that he's/that is] 20 [you are/you're/your] hands writing [and/on] you 21 said [know/no], [and/on] it says test is it a 22 {TEUS} sticks colon on [then/they knew/they know] 23 there are [4/four] lines, I wanted [to know/ton] 24 did [you are/you're/your] computer program Page 191 1 encompass [that/this a] formula? 2 MR. GOLDMAN: 3 MR. GOLDMAN: To do this {HAPLT} did 4 analysis that you were talking about. 5 Q. The {PROELG} that you just 6 [told/totaled] me about [that/this a] 7 [we have been/we've been] talking {PWEURPBLGTS} 8 was it written to you are you asking was it 9 written to obtain [that/this a] test? 10 Q. [Know/No] [I mean/I'm/I am] 11 asking if [that/this a] formula was part of the 12 program? 13 A. Part of the program used 14 requests [had/dollars] this test to be run 15 [it's/its] the {SOPTD} rare {-RS/EPL} bedded in 16 the software this formula excess [had/dollars]. 17 Q. If [it's/its] {EPL} bedded in 18 the software [then/they knew/they know] isn't it 19 part of the {PROELG}? 20 A. If you wanted to look at it 21 [that/this a] [way/weigh], [objecting/okay], we 22 did not or I did not enter this formula into the 23 program. 24 Q. [Know/No] it was already in the Page 192 1 program [so/sew] [that/this a] when you put the 2 [numbers/numbs] in the computer put those 3 [numbers/numbs] [threw/through] [that/this a] 4 formula [and/on] [then/they knew/they know] gave 5 {AU} answer? 6 MR. GOLDMAN: 7 MR. GOLDMAN: Before {AOE} answer 8 [I object/I be] [to the/to tell] form, I think 9 she said it was in the software, 10 [she is/she's/she say] talking the program she 11 wrote. 12 A. This formula is not {SREUPS} 13 {ABL} to me as part of my program. 14 Q. Right but when you write the 15 program, you can put [that/this a] formula in 16 [threw/through] various codes or whatever can't 17 you? 18 A. I requested the {SOFTS} wear to 19 run this test. 20 Q. Okay. can you incorporate 21 [that/this a] software into [you are/you're/your] 22 program? 23 A. Yes, I am writing, my program 24 [is/\S] are part, I'm using [that/this a] Page 193 1 software, my [hole/whole] program is written into 2 [that/this a] software. 3 Q. [So/Sew] [you have/you've] a 4 formula [that's/that he's/that is] [4/four] 5 [leans/liens] long? 6 MR. GOLDMAN: 7 MR. GOLDMAN: [Well/Well,] [it's/its] 8 [4/four] lines long [on/and] [hear/here], 9 [I object/I be] to the. 10 Q. [4/Four] lines long was printed 11 [on/and] that page. 12 A. Okay . 13 Q. [You are/You're/Your] program 14 was designed was it not to give you the for 15 instance the [numb/number] of subjects that went 16 from zero [1/one] to [3/three], [4/four] on the 17 ham b [3/three] who were {EBGS} exposed to 18 {PROEUZ} that was just a part of 19 [you are/you're/your] program? 20 A. Right . 21 Q. ? 22 Q. Did [that/this a] part of the 23 program use information gathered use information 24 or use this formula? Page 194 1 A. No. 2 Q. Okay. where can did this 3 formula come into [you are/you're/your] program? 4 A. After the part of the program 5 [that/this a] {AOE} enumerates identifies the 6 [patience/patients/patient's/patient] in which 7 [then/they knew/they know] occur going from {AOE} 8 row [1/one] to [a/an] [3/three] or [4/four], 9 [then/they knew/they know] I requested this test 10 to be done. 11 Q. Okay. ? 12 A. To compare those {PROE/PORS} 13 [is/\S]. 14 Q. Compare those {PROE/PORS} 15 [is/\S] to [what/when a] {SEUFRPBLGTS} this 16 particular test compares the {ODZ} ratio between 17 each of the different {STRAT} [a/an], in our case 18 [a/an] {STRAT} an is [a/an] [clinically/clinical] 19 trial [so/sew] it {KPAOUTS} [a/an] {ODZ} ratio 20 for each clinical trial [and/on] 21 [then/they knew/they know] compares those across 22 all the {TRAOEULGS}? 23 Q. [So/Sew] it {KPAOUTSZ} [a/an] 24 {ODZ}, [17/seventeen] {ODZ/RAEUGS/KWROES} Page 195 1 {O*EUFRPBLG}? 2 A. No this test could only have 3 been used in those cases where we sub set 4 [had/dollars] the trials. 5 Q. [What/When a] do you mean sub 6 [set/is he the] [had/dollars] [tell us/the] 7 trials? 8 A. There was an analysis done 9 [on/and] just those trials [that/this a] 10 [had/dollars] Fluoxetine continue [and/on] 11 placebo [and/on] that was [7/seven] trials, there 12 was another analysis [that/this a] used trials 13 [that/this a] had [boat/both] Fluoxetine continue 14 [and/on] try stick {KHREUBGS}, there are were 15 [12/twelve] trials, this test was done for each 16 of those sub sets. 17 Q. [So/Sew] was this test done in 18 [a/an] [sense/since] to make the [12/twelve] 19 trials compatible with the [7/seven] trials? 20 A. No. 21 Q. Was it done [so/sew] 22 [that/this a] the [12/twelve] trials could be 23 compared [to the/to tell] [7/seven] trials? 24 A. No. Page 196 1 Q. [So/Sew] {WHAPL} exactly was it 2 done for? 3 A. It compares the trials within 4 the [7/seven] trials, it tests for whether or not 5 the {ODZ} radiologist {KWROEGS} a cross those 6 [3/three]. 7 [7/Seven] trials are the same 8 [and/on] [then/they knew/they know] it tests 9 [that/this a] for the [12/twelve] trials, would 10 {WHRORBTS} the [12/twelve] trials within 11 [that/this a] group, the {ODZ/RAEUGS/KWROES} 12 are the same. 13 Q. Weren't you just looking to see 14 if there was [a/an] [social/association] between 15 Prozac [and/on] the [rise/rice] on the Ham-D 16 [3/three] score {TKPR} zero to [1/one] to 17 [3/three] to [4/four]? 18 A. This test does not address 19 [that/this a]. 20 Q. Okay. . {THAP} test {HAOS} 21 nothing to did do with it? 22 A. [It's/Its] relate {STKPWHRAOD} 23 [objecting/okay] let's try one [mother/more] time 24 [house/how's/how is] it related. Page 197 1 A. . 2 A. Did impacts the inferences 3 [you would/you'd] make from those tests 4 [that/this a] do directly compare the rates 5 between treatments, this tells you how consistent 6 [that/this a] particular inference [may be/maybe] 7 across each trials, across each of the trials. 8 Q. Okay. . 9 Q. The formula which 10 [we have been/we've been] discussing 11 [is that/is this a] part of the {PWROES} low day 12 test? 13 MR. GOLDMAN: 14 MR. GOLDMAN: Do you neat to look at it 15 to answer [that/this a] question. 16 A. Yes [that's/that he's/that is] 17 the breast low day test. 18 Q. The other man description which 19 [we've/we have] discussed which arose out of the 20 [in/inch/I know/I knew] formation which was 21 gathered during the pooling of the 22 [clinically/clinical] trials, were was one of 23 those man description entitled Fluoxetine 24 continue in try stick click re{TPRABG/TREU} Page 198 1 major depressive disorder? 2 A. What was [that/this a] title 3 again. 4 Q. This [doesn't/don't] have to be 5 an exhibit [I will/I'll/ill] just show {ULT} 6 title? 7 A. No. 8 Q. Was Fluoxetine continue versus 9 {TRAZ} don't efficacy [and/on] activate [is/\S] 10 sedating [affects/effects]? 11 A. No. 12 Q. Was [high/hi] [dose/does] 13 Fluoxetine continue efficacy [and/on] activate 14 [go/\ing] sedating {TPREGTS} if agitated [and/on] 15 re{TART} [had/dollars] depression? 16 A. No. 17 Q. Now these [3/three] articles 18 which I just mentioned, they came out between 19 December, 1990 [and/on] July, 1991. 20 [Is that/Is this a] true? 21 MR. GOLDMAN: 22 MR. GOLDMAN: [Well/Well,] hold 23 [on/and] for {AL} second. If [you have/you've] 24 the publication or at [lease/least] the title Page 199 1 pages, [may be/maybe] you could show 2 [them/they mean] to her [and/on] she could con if 3 I am [that/this a] or not. 4 Q. Okay. [I will/I'll/ill] ask 5 you when were they published. 6 A. If [doesn't/don't] stay. 7 MR. GOLDMAN: 8 MR. GOLDMAN: {WHAOSZ} the {KWEU}. 9 Q. The {KWEU} is in 10 [addition/edition] to the are these [3/three] 11 articles in [a/an] {STKEUGS} to anything 12 [we've/we have] discussed so far [today//ed to] 13 {SKWR}? 14 MR. GOLDMAN: Were are they other than 15 [what/when a] [we have been/we've been] take 16 {PWG} up to now. 17 ATTORNEY 1: 18 ATTORNEY 1: Yes. 19 A. Yes. 20 Q. Could [I have/I've] those back 21 {STKPWHRAOEUFRPLGTS} tendered 22 {STKPWHRAOEURPBLGTS}? 23 Q. [So/Sew] [I mean/I'm/I am] just 24 trying to get an idea of {HOURPL} articles you Page 200 1 [actual/actually] worked [on/and] between June 2 [ever/every] [19/nineteen] 09 [and/on] 3 [except/September] of 1991? 4 MR. GOLDMAN: {SKWR} load {AOE} object 5 [to the/to tell] form when you say articles do 6 you mean man {SKREUPLS} [that/this a] were 7 submitted or articles [that/this a] were {PWUBTD} 8 during that period of time, I think she told you 9 earlier about man description [and/on] {ARLSZ} 10 [on/and] which her name [appeared/a period] 11 [way/weigh] back in the beginning. 12 Q. [So/Sew] didn't until me about 13 man description but now she just [told/totaled] 14 me [that/this a] these [3/three] were not part of 15 [that/this a] discussion? 16 A. They were part of the 17 discussion when I said [their/there/they're] were 18 about [6/six], [that/this a] I was a co-author of 19 {STKPWHAO} [objecting/okay]. 20 A. I'm sorry. 21 Q. [That's/That he's/That is] all 22 right. 23 Q. The article that was published 24 in the British medical {SKWRUPBL}, was Page 201 1 [that/this a] submitted to any other 2 {SKWRURPBLS}? 3 A. Yes. 4 Q. [Down/Do you know] what journal 5 it was submitted to {O*EUFRPBLGTS} you [knew/new] 6 [he know/he knew/EN\] {TKPWHRAPBDZ} journal the 7 medicine? 8 Q. What happened with 9 [that/this a]? 10 A. [Well/Well,] they rejected the 11 paper. 12 Q. Why was [that/this a]? 13 A. I don't know. 14 Q. Was the [knew/new] 15 [he know/he knew/EN\] {TKPWHRAOPBD} journal the 16 medicine in [seat/see the/receipt] of the 17 manuscript prior to the British medical journal? 18 A. Yes. 19 Q. Did they -- do you happen 20 [to know/ton] if it was rejected because it was 21 authored [buy/by] Lilly [employee's/employees]? 22 A. I don't know [that/this a] for 23 sure. 24 Q. Was it rejected because of the Page 202 1 procedures [that/this a] were followed? 2 MR. GOLDMAN: 3 MR. GOLDMAN: [I object/I be] 4 [to the/to tell] form [what/when a] procedures. 5 ATTORNEY 1: 6 ATTORNEY 1: [Scientific/Scientific] 7 procedures. 8 MR. GOLDMAN: 9 MR. GOLDMAN: In the manuscript or. 10 MR. GOLDMAN: 11 MR. GOLDMAN: 12 ATTORNEY 1: 13 ATTORNEY 1: Yes in the manuscript, 14 [there is/there's/theirs] a description is there 15 not of the procedure, the [scientific/scientific] 16 procedure that was used. 17 A. I don't know why it was 18 re{SKWREBGTD} [had/dollars]. 19 Q. [You have/You've] absolutely 20 [know/no] idea? 21 A. No, I don't recall 22 [what/when a] the [rejection/rejects] letter 23 said. 24 Q. ? Page 203 1 A. Or even if [what/when a] it did 2 say would be the real reason. 3 Q. Well, did you really not care 4 whether it was published or not? 5 A. Yes, I [cared/carried]. 6 Q. Did you care whether it was 7 published in the [knew/new] {EPBL/TKPWHRAPBDZ} 8 journal the medicine or the Oklohoma a state 9 university journal of medicine? 10 MR. GOLDMAN: 11 MR. GOLDMAN: Better not be anybody 12 from Oklohoma an in [hear/here]. 13 ATTORNEY 1: 14 ATTORNEY 1: I forgot where I was. 15 ATTORNEY 1: 16 ATTORNEY 1: Not to put 17 [down/do you know] Oklohoma [a/an], 18 [I mean/I'm/I am] just saying [knew/new] [and/on] 19 {TKPWHRAPBDZ} journal of medicine is [well/well,] 20 known around the world {-RBG} [may be/maybe] the 21 Oklohoma [a/an] {SKWRUPBL} of medicine is too but 22 [I mean/I'm/I am] saying did you care where it 23 was {PUBTDZ}. 24 A. No not, {-RB} I don't {AOEURBL} Page 204 1 concern myself with which journal. 2 Q. When it was published 3 [bite/buy the/by the] British medical journal, 4 did you feel {PROUDZ} of {URBZ}? 5 A. Yes, [I would/I'd] have felt 6 proud [know/no] matter [what/when a] journal. 7 Q. Were you disappoints 8 [had/dollars] when the [knew/new] 9 [he know/he knew/EN\] {TKPWHRAPBDZ} journal of 10 medicine {RAOEPL/SKWREBGT} [had/dollars] it? 11 A. Not really. Yes in the 12 [sense/since] it meant we needed to revise the 13 work appropriate for another journal. 14 Q. Did [doctor/Dr./Doctor,/Doctor] 15 {TOL} son help in revising the work? 16 A. I don't recall when he came to 17 the company. 18 Q. {STKPWHRAOEUFRPBLGTS}? 19 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 20 MARKED FOR IDENTIFICATION AND 21 RECEIVED IN EVIDENCE.) 22 Q. Have you {REDZ} 23 [plaintiff's/plaintiffs] exhibits [6/six]? 24 A. Yes. Page 205 1 Q. Do you know if the manuscript 2 discussed in [that/this a] communication [and/on] 3 [I mean/I'm/I am] not sure if man {SKWREUPT} is 4 the word [that's/that he's/that is] used 5 [their/there/they're] but is the manuscript which 6 was rejected [bite/buy the/by the] [knew/new] 7 [and/on] {TKPWHRAPBDZ} journal of medicine 8 discussed in [that/this a] communication? 9 A. What is the question. 10 Q. Is the writing [that is/that's] 11 discussed in [that/this a] communication, the 12 same writing as the manuscript which was 13 re{SKWREBGTS} [had/dollars] [bite/buy the/by the] 14 [knew/new] [he know/he knew/EN\] {TKPWHRAPBDZ} 15 {SKWRURPBLG} of medicine? 16 A. No. 17 Q. {THAEUSZ} the manuscript that 18 was the [17/seventeen] pooled {KHRAOEUPBL} 19 trials. [Is that/Is this a] manuscript discussed 20 in [that/this a] communication 21 [plaintiff's/plaintiffs] exhibit [6/six]? 22 A. Yes {STKPWHRAOEUFRPLT} the one 23 [that's/that he's/that is] being sent 24 [to the/to tell] British medical journal is Page 206 1 discussed [hear/here]. 2 Q. Okay. [is that/is this a] a 3 different manuscript than the one sent 4 [to the/to tell] [knew/new] [and/on] 5 {TKPWHRAPBDZ} journal the [mid-/mid] sin? 6 A. I [refer/referrer] do it as the 7 same manuscript but [it's/its] a different, this 8 is specific to [that/this a] draft. 9 Q. [So/Sew] [there/their/they're] 10 were minor changes between the one that was 11 {SEPTS} [to the/to tell] bring the {EURB} 12 [medical/med] salary calendar {SKWRURPBT} abdomen 13 the [knew/new] [he know/he knew/EN\] 14 {TKPWHRAPBDZ/SKWRURPB} the {PHE} will {SEUL}? 15 A. Yes. 16 Q. Does this refresh 17 [you are/you're/your] 18 [erection/erects/recollection] about 19 [doctor/Dr./Doctor,/Doctor] {TOL} son 20 [role/roll]? 21 A. He did review it, [it's/its] 22 {KHRAOEUR} from this memo, yes. 23 Q. Do you recall him being upset 24 [that/this a] the manuscript was mailed Page 207 1 [to the/to tell] British medical journal 2 [without/would you tell] his review, did {THAFR} 3 occur? 4 A. From reading this it appears he 5 reviewed it before it was mailed [to the/to tell] 6 bring the {EURB} medical journal. 7 Q. Okay. . Was 8 [doctor/Dr./Doctor,/Doctor] {TOL} son 9 [doctor/Dr./Doctor,/Doctor] {PWAOES} list 10 superior? 11 A. Yes, [I mean/I'm/I am] pretty 12 sure. 13 Q. As far as you know did they get 14 [along/a long] all right? 15 A. As far as I know. 16 Q. [Objecting/okay]. 17 {STKPWHRAOEUFRPBLGTS} 18 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 {STKPWHRAOEUFRPBLGTS} 22 Q. [I mean/I'm/I am] going to show 23 you {PHRFGS} exhibit [7/seven] [and/on] [8/eight] 24 at the same time? Page 208 1 A. {*R} are {*R/WRAO*EURBG} 2 {AO*EURB/-RBG}. 3 Q. Look at 4 [plaintiff's/plaintiffs] exhibit [7/seven] 5 [first/1st], [objecting/okay]. [And/On] 6 [I would/I'd] just like to ask you 7 [miss/Ms./Miss] sale [err//er] 8 [is that/is this a] [you are/you're/your] 9 handwriting? 10 A. Yes. 11 Q. The document is [2/two] pages 12 long, [is that/is this a] [you are/you're/your] 13 hands writing [on/and] both {PAEUPBLGTSZ}? 14 A. Yes. 15 Q. [And/On] could you describe to 16 my when this document was created? 17 A. June [twenty-one/21], 1991. 18 Q. [And/On] was it created during 19 a meeting or {WAOS} it created as a reference for 20 you or {SABLGT}ly why was it created? 21 A. [I mean/I'm/I am] not sure. 22 Q. Okay. . Does it contain [a/an] 23 {KWAOEUPBDZ} of [things/thinks] to do list for 24 you? Page 209 1 A. Yes. 2 Q. [And/On] these things 3 [that/this a] [you have/you've] to do what 4 project why you involved in at the time 5 [that/this a] {THAOELS} [things/thinks] had were 6 in conjunction with {EURPBLGSZ} [I mean/I'm/I am] 7 pretty sure [it's/its] will directly related 8 [to the/to tell] b m [j/j] manuscript? 9 Q. Okay. . 10 ATTORNEY 1: 11 ATTORNEY 1: Can can he take [a/an] 12 [brake/break] {STKPWHRAOEUFRPBLGTS}. 13 (A SHORT RECESS WAS TAKEN.) 14 {STKPWHRAOEUFRPBLGTS/WR*} 15 ATTORNEY 1: 16 ATTORNEY 1: 17 ATTORNEY 1: 18 Q. [So/Sew] exhibit l is [a/an] 19 [things/thinks] to do list regarding the man 20 {SKREUP} that was submit [today//ed to] b m 21 [j/j]? 22 A. Exhibit [7/seven]. 23 Q. [I mean/I'm/I am] exhibit 24 [7/seven]? Page 210 1 A. Yes. 2 Q. Okay. . Exhibit [8/eight], is 3 [that/this a] [you are/you're/your] hands writing 4 [on/and] exhibit [8/eight]? 5 A. Yes. 6 Q. Could you describe 7 [what/when a] [that/this a] document is? 8 A. Looks like another to do list. 9 Q. [And/On] do you know what the 10 list is in conjunction with, [what/when a] 11 project or? 12 A. . 13 A. [I mean/I'm/I am] not sure, 14 [I mean/I'm/I am] pretty sure [it's/its] 15 [probable/probably] the international, has to do 16 with the international, or the outside 17 [u.s./u.s.] analysis. 18 Q. Okay. . 19 Q. I wanted to go back to the one 20 question about exhibit [3/three] do you remember 21 when we were talking [that/this a] exhibit, 22 exhibit [3/three]? 23 A. Yes. 24 Q. [Down/Do you know] Page 211 1 [is that/is this a] a draft or [a/an] 2 [final/finally] copy of a package insert or 3 [down/do you know]? 4 A. It looks like a draft. 5 Q. Do you have any 6 [personal/personnel/personally] knowledge of 7 [that/this a]? 8 A. No. 9 Q. [Down/Do you know] would 10 somebody in [miss/Ms./Miss] pot convince position 11 have knowledge of [that/this a]? 12 MR. GOLDMAN: 13 MR. GOLDMAN: [I object/I be] to the 14 formats to [what/when a] January pot {SREUPB} or 15 somebody in her position [knows/nose/no, sir] or 16 don't know {SEUFRPBLGTS} to go book {WHRORBTS} 17 [it's/its] a draft, [I would/I'd] 18 [toss/to say/thoracic outlet syndrome] it has to 19 be because [I mean/I'm/I am] sure the 20 [final/finally] copy is not going to have crossed 21 out words {SOEU} [it's/its] a draft. 22 Q. Do you know why certain words 23 are crossed out? 24 A. No. Page 212 1 Q. ? 2 ATTORNEY 1: 3 ATTORNEY 1: 4 Q. This [next/necks] one is a big 5 one [Oh,/owe/oh] [we are/we're] going to have 6 equate {TPAOR/STKPWHRAOEUFRPBLGTS}? 7 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 8 MARKED FOR IDENTIFICATION AND 9 RECEIVED IN EVIDENCE.) 10 ,{S-RBGSZ}. 11 Q. Okay. . {STKPWHRAOPL} have you 12 had a chance to review [plaintiff's/plaintiffs] 13 exhibits [9/nine] {EURBLGS}? 14 A. Yes. 15 Q. On the front page of 16 [plaintiff's/plaintiffs] exhibit [9/nine], it 17 looks like [it's/its] a copy of a folder [and/on] 18 in the upper right-hand corner I believe it says 19 {SAOER/PWAOES} [questions/question is] is that 20 correct? 21 A. Yes, that's correct. 22 Q. [Is that/Is this a] in 23 [you are/you're/your] {HAOPBDZ} write? 24 A. . Page 213 1 A. Yes, it is. 2 Q. [What/When a] exactly were 3 {SAOER/PWAOELS} [questions/question is] 4 {SEUFRPBLGTS} [there is/there's/theirs] a 5 question [he had/he'd] a question about 6 suicidality in {THOEPS} patient who are obese in 7 [addition/edition] to being depressed, [and/on] 8 [he had/he'd] a question about specifically the 9 sixty myelogram dosage of Fluoxetine continue in 10 the fixed [dose/does] trial, Wheadon a fixed dose 11 trial [that/this a] had 06 {PHLGS/STKPWRAO} now 12 the bulk of [plaintiff's/plaintiffs] exhibit 13 [9/nine] is a a collection of graphs [and/on] 14 different kinds of squares whatever is it not? 15 A. [It's/Its] a big part of it, 16 yes. 17 Q. [What/When a] were those graphs 18 used for? 19 A. They were used to help address 20 those [questions/question is]. 21 Q. Were they used in 22 [any way/anyway] in conjunction with the b m 23 [j/j] {ARLG}? 24 A. No, they weren't. Page 214 1 Q. Do you know what Prozac {SRER} 2 {PWAEUTD/EUPLS} are? 3 A. No were {STKPWHRAOEUFRPBLGS}. 4 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 {STKPWHRAOEUFRPBLGTS/R*ER/R*R} 8 {STKPWHRAOP} [on/and] review of 9 [plaintiff's/plaintiffs] exhibit [10/ten] does 10 [that/this a] refresh [you are/you're/your] 11 [erection/erects/recollection] as to 12 [what/when a] Prozac {SRER} [bait/bathe] {EUPLS} 13 are. 14 A. Will [in/inch/I know/I knew] 15 [what/when a] they are, this document, 16 [their/there/they're] answer to 17 [questions/question is]. 18 Q. Are they the answer 19 [that/this a] little {SEU} [employee's/employees] 20 are posed to give when asked those 21 [questions/question is]? 22 A. No, Lilly 23 [employee's/employees] were not given this, all 24 Lilly employ {AOEGS} were not given this, I don't Page 215 1 recall the purpose of this. 2 Q. Was it do you know if it was 3 used [buy/by] detail men? 4 MR. GOLDMAN: 5 MR. GOLDMAN: This document. 6 ATTORNEY 1: 7 ATTORNEY 1: Yes. 8 A. I don't know. 9 Q. Do you know what stat exact is, 10 is it an it, [x/examine/exam] [a/an] {KR} it? 11 A. Yes. 12 Q. {WHAOSZ} [that/this a]? 13 A. [It's/It is/Its] a software 14 package. 15 Q. Did you [eyes/ice] 16 [that/this a] software package in the during the 17 is it a {TEUS} calendar analysis which became the 18 b m [j/j] article {SEUFRPBLGTSZ} [know/no], 19 [I mean/I'm/I am] {PRAOETD} I sure [that/this a] 20 those were not part of the b m [j/j]? 21 Q. [What's/What is] cat mode {KR} 22 an it {PH/O/PH} did? 23 A. [It's/It is] a particular 24 procedure within {STAS} which is another is it a Page 216 1 {STEUSZ} calendar software package. 2 Q. How do you spell {SAS}? 3 A. Is an is. 4 Q. Was [that/this a] used in 5 [rung/running/wrung] the statistical analysis 6 either {SAS} or cat mode? 7 A. {SAS} was used, the particular 8 procedure I don't think was. 9 Q. Was any other software used in 10 con junk with [that will/that'll] particular 11 statistical analysis? 12 A. [Forth/For the/Fourth] b m 13 [j/j] paper. 14 Q. Gentlemen? 15 A. No [know/no]. 16 Q. {SPAOEUBGS/*R} speaking of 17 the b m [j/j] article, I just happen to have a 18 copy with me. [And/On] [I would/I'd] like to 19 read to you from the abstract, the abstract goes 20 [threw/through] the objective, design, results, 21 [and/on] [then/they knew/they know] the 22 conclusion. The conclusion [state's/states] 23 quote data from these trials do not show 24 [that/this a] Fluoxetine continue is associated Page 217 1 with an increased risk of suicidal acts or {PHER} 2 {SKWREPBTD} of substantial will suicidal thoughts 3 among depressed 4 [patience/patients/patient's/patient]. 5 [That's/That he's/That is] the end of the quote. 6 [I would/I'd] like to ask you, was 7 [therefore/there ever] a draft of this article 8 [and/on] this abstract where the word substantial 9 was not used? In other words the reading {WEPB} 10 something like this, with an increased risk of 11 suicidal acts or {PHER/SKWREPBS} of suicide the 12 thoughts among depressed 13 [patience/patients/patient's/patient]? 14 MR. GOLDMAN: 15 MR. GOLDMAN: Would you like do you 16 need to look at the [that/this a]. 17 A. No. 18 A. [Their/There/They're] might 19 have been. 20 Q. [Well/Well,] now, why would 21 substantial have been added to this particular 22 draft? 23 MR. GOLDMAN: {SKWR} let heat object 24 [to the/to tell] form, she said in response to Page 218 1 [you are/you're/your] earlier question {STHAOE} 2 said [their/there/they're] might have been 3 [and/on] now [you are/you're/your] assuming 4 [that/this a] it in fact happened [and/on] asking 5 her why. 6 Q. In [that/this a] {SREPBLT} why 7 would substantial be [add/ad] [today//ed to] this 8 draft? 9 MR. GOLDMAN: 10 MR. GOLDMAN: [I object/I be] 11 [to the/to tell] form, I think that would call 12 [on/and] her to speculate 13 [without/would you tell] the {PWEPB} fit of 14 either have having the article this in front of 15 [hear/here] or any such draft. 16 Q. ? 17 ATTORNEY 1: 18 ATTORNEY 1: [She is/She's/She say] the 19 author. 20 MR. GOLDMAN: 21 MR. GOLDMAN: She goes an author, 22 [right/write]. 23 ATTORNEY 1: 24 ATTORNEY 1: [She is/She's/She say] an Page 219 1 author. 2 Q. [So/Sew] I thought 3 [may be/maybe] as an author [you would/you'd] 4 [know/no] the own to [that/this a] question? 5 A. [I can/I could] speculate. 6 MR. GOLDMAN: 7 MR. GOLDMAN: [You are/You're/Your] not 8 supposed to {SPEUBG} [late/lathe]. 9 Q. How did certain words {KWOPL} 10 to be in the [final/finally] copy, in the 11 [final/finally] printed b m [j/j] article 12 [that/this a] were not present in a draft of the 13 same article such as the word substantial in this 14 phrase, [down/do you know] let me ask you this:, 15 was substantial if it was in {TPABLGT} added in 16 the event [that/this a] it was [add/ad] the, 17 would that be because the is it a {TEUS} sticks 18 showed an increase or {AE} mere {SKWREPBS} of 19 none substantial suicidal {THOUTSZ}? 20 A. No that would not be the 21 reason. 22 Q. [So/Sew] since you are an 23 author, [what/when a] does substantial 24 [mean/me know] in [that/this a] phrase? Page 220 1 A. . 2 MR. GOLDMAN: Let [hear/here] look at 3 it. 4 Q. [It's/Its] in the conclusion of 5 the abstract. 6 A. Emergence of substantial will 7 suicide the will thoughts to me {EUPLG} 8 {PHRAOEUS} [that/this a] [it's/its] an analysis 9 [that/this a] [we've/we have] talk about before 10 [that/this a] patient go [their/there/they're] 11 from see {RO} [1/one] at [bias/buys] line to 12 [3/three] or [4/four] {TPH*EUG} anytime during 13 the trial [and/on] remay have again [that/this a] 14 analysis different names of cross drafts [and/on] 15 the reason [go/\ing] for this particular wording, 16 [I mean/I'm/I am] not sure [probable/probably] to 17 discontinue {TKPWEURB} to say [that/this a] 18 [3/three] or [4/four] is implied [that/this a] 19 [that is/that's] substantial. 20 Q. [So/Sew] an increase from 21 [0/oh] to [1/one] to [2/two] do [3/three] {PWO} 22 not be substantial? 23 A. Pardon me. 24 Q. If a subject went from zero to Page 221 1 [1/one], to [2/two], to [3/three], that would not 2 be considered an increase in suicidal ideation 3 according to this article? 4 MR. GOLDMAN: 5 MR. GOLDMAN: Let me object 6 [to the/to tell] form, you changed 7 [you are/you're/your] {KWER}, the [first/1st] 8 question was I think that would not be 9 substantial now your question is that would not 10 be a change in suicidal ideation [so/sew] 11 [what's/what is] the question. 12 Q. Okay. [tell us/the] 13 [first/1st] question is that would not be 14 substantial would it? 15 A. Can you {PHRAOEUSZ} describe. 16 Q. To go from [0/oh], [1/one] to 17 [2/two], [3/three]? 18 A. If a patient went from [a/an] 19 [0/oh], [1/one] to [a/an] [2/two] or [3/three]. 20 A. Right . 21 Q. If {AP} patient started at 22 [0/oh] [and/on] went to [a/an] [3/three], 23 [that/this a] is counted as emergence of 24 substantial ideation? Page 222 1 Q. Well, I believe? 2 A. Or [1/one] to [a/an] [3/three]. 3 MR. GOLDMAN: I believe. 4 Q. I believe you just said 5 substantial increase in suicidal ideation was 6 [0/oh], [1/one] to [3/three], [4/four]? 7 A. They had an is he [0/oh], 8 [1/one] to base line [3/three], [4/four] sometime 9 during the study {STKPWHRAOEU} [so/sew] if {AP} 10 patient went from [0/oh] to [2/two], 11 [that/this a] would not be counted as an increase 12 in suicidal ideation or that would not be counted 13 as a substantial increase {ORPL} exactly could 14 you describe. 15 A. That would not be count 16 [had/dollars] as [a/an] [inches/insurance] 17 {TKEUPBS} of emergence substantial suicidal 18 thoughts. 19 Q. Would [it be/it been] recorded 20 in any other manner, would [it be/it been] 21 recorded as an incidents in [tell us/the] 22 increase of suicidal ideation but not substantial 23 {STKPW}? 24 MR. GOLDMAN: Page 223 1 MR. GOLDMAN: Let {HAOE} object 2 [to the/to tell] form when you say recorded, do 3 you mean recorded in this article somewhere. 4 ATTORNEY 1: 5 ATTORNEY 1: {TPHOEU} [I mean/I'm/I am] 6 recorded on the c l f. 7 A. The c r f records all the ham 8 {TK-PLT} [I'd/eyed/identify] edges [that/this a] 9 are re[so/sew] yes. 10 Q. Would [it be/it been] discussed 11 in [that/this a] article? 12 MR. GOLDMAN: 13 MR. GOLDMAN: A change from [0/oh] to 14 [2/two]. 15 A. {KWRAOE/STKPWRAO}. 16 Q. Take you time {*R/KR*R} 17 {R*R}? 18 Q. ? 19 MR. GOLDMAN: {STKPWHRAOT} that's it. 20 Q. The increase in the Ham-D 21 [3/three] scale from [0/oh] to [2/two]? 22 A. Yes it would be {KOUPBTSDZ} 23 [had/dollars] as part of the analysis 24 [that/this a] looked as worsening of suicidal Page 224 1 ideation [and/on] [that is/that's] any worsening 2 [and/on] it would be count [had/dollars] in 3 [that/this a] [a/an] {TPHAL/TPHAL/SEUS}. 4 Q. By the way, [may be/maybe] we 5 should {PHABG} [that/this a] as 6 [plaintiff's/plaintiffs] exhibit 7 {STKPWHRAOEUFRPBLGTS}? 8 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 9 MARKED FOR IDENTIFICATION AND 10 RECEIVED IN EVIDENCE.) 11 {STKPWHRAOEUFRPBLGTS} 12 Q. Does the b m [j/j] article make 13 any conclusion about the effectiveness of Prozac 14 as compared to try sick {HREUBGS}? 15 MR. GOLDMAN: 16 MR. GOLDMAN: Take 17 [you are/you're/your] time [and/on] look at it. 18 A. No. 19 Q. Can I see [that/this a] please 20 {STKPWHRAOEUFRPBLGTS} [handing/handling] 21 {STKPWHRAOEUFRPBLGTS}? 22 Q. Perhaps as an author you can 23 describe [what/when a] this means 24 [then/they knew/they know]? Page 225 1 A. [I mean/I'm/I am] reading from 2 page [6/six] [89/'89/eighty-nine], {AL} 3 significantly higher percentage of 4 [patience/patients/patient's/patient] treated 5 with Fluoxetine continue experienced improvement 6 than did [patience/patients/patient's/patient] 7 treated with placebo, [parentheses/paren] p less 8 than [0/oh] point [1/one] [0/oh] [0/oh] [1/one] 9 end [parentheses/paren] seem {O} colon, there was 10 no significant different in improve {-PLT} 11 between [patience/patients/patient's/patient] 12 treated with Fluoxetine continue [and/on] those 13 treated with try sick {PHREUBG} anti-depressant. 14 MR. GOLDMAN: {SKWR} let {HAOE} see it 15 [so/sew] she can get the context. 16 A. [What's/What is] the question 17 again. 18 Q. According to this study, is 19 Prozac [mother/more] effective than try sick 20 {HREUBGS}? 21 A. . 22 MR. GOLDMAN: 23 MR. GOLDMAN: You {REDZ} her a passage 24 [and/on] [then/they knew/they know] you asked her Page 226 1 [what/when a] it meant [so/sew]. 2 Q. I'm sorry, I did read you a 3 passage? 4 A. Yes [it's/its] [a/an] higher 5 percentage of 6 [patience/patients/patient's/patient] experienced 7 [I mean/I'm/I am] {PROFPL} than 8 [patience/patients/patient's/patient] with 9 placebo [and/on] if [there is/there's/theirs] 10 [know/no] different between employ 11 [objection/ox/oxygen] [and/on] try sick {HREUBGS} 12 [it's/its] [ever/every] referring to improvement 13 in suicide the ideation. 14 Q. You mean lessening suicidal 15 identification {KWRAEUGS}? 16 A. Yes [and/on] I didn't interpret 17 {PRET} [that/this a] as being overall efficacy. 18 Q. [So/Sew] [it's/its] referring 19 [then/they knew/they know] to [1/one] symptom of 20 depression [and/on] not depression across the 21 [Board of Directors/boards] in depressions many 22 symptoms? 23 A. That's right. 24 Q. {STKPWRAO}? Page 227 1 Q. Now, this article and the {*R} 2 and the [17/seventeen] [clinically/clinical] 3 trials used [a/an] [u.s./u.s.] data base is that 4 correct? 5 A. Yes. 6 Q. [And/On] it sues [had/dollars] 7 [a/an] [u.s./u.s.] data base because [well/well,] 8 let me ask [that/this a], did it use [a/an] 9 [u.s./u.s.] data base for any particular purpose? 10 A. [What's/What is] at question 11 again. 12 Q. Was [a/an] [u.s./u.s.] data 13 base used for this article for any particular 14 purpose, why didn't they use the inter are 15 national data base with the [u.s./u.s.] data 16 base? 17 A. . 18 A. The [u.s./u.s.] data base 19 [well/well,] I'm sorry can you repeat the 20 question, again or rephrase it. 21 Q. Is there a reason why only the 22 [u.s./u.s.] data base was used? 23 A. For this paper. 24 Q. For this paper? Page 228 1 A. This paper was defined as a 2 paper just {OPBS} the [u.s./u.s.] data 3 {STKPWHRAEUS} for any reason. 4 A. [That's/That he's/That is] 5 [what/when a] data, the [u.s./u.s.] data was 6 available at the time to be able to run analyses. 7 Q. Is an is it a cities {SKAL} 8 analysis Prozac degrees {EUFL} [mother/more] 9 accurate as the [numb/number] of subjects 10 increases? 11 A. I don't think {AOBG/RAT}, 12 [it's/its] [mother/more] [well/well,] not 13 necessarily. 14 Q. Well, the does the confidence 15 interval go up if [you have/you've] [mother/more] 16 subjects? 17 A. It decreases. 18 Q. [So/Sew] 19 [that's/that he's/that is] better, [right/write]? 20 A. Yes. 21 Q. At the end of the article 22 before the listing of citations, I see 23 [that/this a] as an author, you thank certain 24 physicians [and/on] research {ERS} listed Page 229 1 [their/there/they're], is that right? 2 A. That's right. 3 Q. If [it's/its] [a/an] 4 [u.s./u.s.] data base, why do you thank research 5 {ERS} from [he know/he knew/EN\] {TKPWHRAPBDZ} 6 [and/on] Germany? 7 MR. GOLDMAN: 8 MR. GOLDMAN: Let me object 9 [to the/to tell] form, I don't know [that/this a] 10 those people are identified as being research 11 {ERS}. 12 Q. Okay. since I only have one 13 copy of document, [I mean/I'm/I am] kind of 14 [doing/dog] this [off/often] the top of my head? 15 MR. GOLDMAN: 16 MR. GOLDMAN: You can come over on look 17 over her shoulder if you if you want. 18 ATTORNEY 1: [Objecting/okay]. 19 Q. It says quote we thank the 20 following individuals for [their/there/they're] 21 review of the data presented [hear/here]. 22 [And/On] [then/they knew/they know] it lists 23 somebody from [he know/he knew/EN\] {TKPWHRAPBD} 24 [and/on] germ [in a/in an] any, do you know why Page 230 1 they are thank [had/dollars]? 2 A. [Well/Well,] [I mean/I'm/I am] 3 not sure why. 4 Q. Could I see [that/this a] for 5 {AL} second? 6 A. Uh-huh. 7 Q. We notice [on/and] this list of 8 people being thank [had/dollars], is {TKPWAEUR} I 9 [d/degenerative] {TOL} son, Saints Paul ram {SEU} 10 medical center, minimum [so the/sew the] [a/an], 11 [is that/is this a] the same 12 [doctor/Dr./Doctor,/Doctor] {TOL} son 13 [that/this a] worked for {AOE} lie Lilly? 14 A. [That/This a] currently works 15 for {AOE} lie Lilly. 16 Q. Yes? 17 A. Yes. 18 Q. He works [had/dollars] for 19 {AOE} lie Lilly in [September/except] of 1991, 20 {TK-PBLTSD} he? 21 A. I don't know. 22 Q. Are you looking for 23 [that/this a] exhibit? 24 A. Yes. Page 231 1 Q. {EUPBLGTSZ}? 2 A. Yes, he did. 3 Q. [So/Sew] [I mean/I'm/I am] just 4 confused, how could [he be/he been] thank 5 [had/dollars] in as a person in minimum 6 [so the/sew the] a reviewing the data presented 7 in this article whether he was an employed 8 [buy/by] Lilly [and/on] wanted to review the 9 article before it was released? 10 A. It's not [unusually/unusual] to 11 name other Lilly [employee's/employees]. 12 Q. But [he's/he is/he say] not 13 listed as a Lilly [employee's/employees], 14 [he's/he is/he say] listed as an individual who 15 reviewed the data presented [hear/here] [and/on] 16 his address is saint Paul ram {SEU} medical 17 center minimum [so the/sew the] [a/an]? 18 A. He was [probable/probably] at 19 [that/this a] location at the time of the earlier 20 submissions of the paper, the earlier drafts of 21 the paper {STKPWHRAOER} [so/sew] he was -- 22 [objecting/okay]. 23 Q. [What/When a] about 24 [doctor/Dr./Doctor,/Doctor] January {TPAUS} Page 232 1 [set/is he the], did you ever work with 2 [doctor/Dr./Doctor,/Doctor] facet? 3 A. Not directly, [know/no]. 4 Q. [Down/Do you know] how many, 5 did he conduct any of the [clinically/clinical] 6 trials [that/this a] are [clued/include/conclude] 7 {TPHD} this article? 8 A. [I mean/I'm/I am] {PRET} the 9 pretty sure [that/this a] he did. 10 Q. Did he contact more than one? 11 A. I don't know. 12 Q. What was the [4/four] letter 13 [designation/destination] of the trial he con 14 {TKUGT} [had/dollars]? 15 A. I don't know. 16 Q. Did they [begin/given] with h? 17 A. Yes. 18 Q. [Down/Do you know] what the 19 [next/necks] [3/three] letters were [on/and] any 20 of the trial? 21 A. No. 22 Q. How about 23 [doctor/Dr./Doctor,/Doctor] {ROES/PWAUPL} up at 24 [masks/mass] {KHAOUS} [etc./et cetera] Page 233 1 [generally/general] hospital in Boston 2 University. Did he conduct any of the 3 [clinically/clinical] trials? 4 A. [I mean/I'm/I am] {PREPLTS} I 5 sure [that/this a] he did. 6 Q. How about 7 [doctor/Dr./Doctor,/Doctor] {TOL} son, did he 8 conduct any [clinically/clinical] trials? 9 MR. GOLDMAN: 10 MR. GOLDMAN: Are you talking about the 11 [ones/once] in the paper. 12 ATTORNEY 1: 13 ATTORNEY 1: Yes the [ones/once] in the 14 paper, the [17/seventeen] trials in the paper. 15 A. I don't know. 16 Q. How about 17 [doctor/Dr./Doctor,/Doctor] win {KER}, in eye 18 [with a/with an] city? 19 A. I don't know. 20 Q. {STKPWHRAOEUFRPBLGTS}? 21 (PLAINTIFFS' EXHIBIT NO. [XX] WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 {STKPWHRAOEUFRPBLGTS} Page 234 1 Q. If you recognize the document, 2 [I mean/I'm/I am] {*R}? 3 Q. [Miss/Ms./Miss] sale [err//er], 4 have you had a chance to review the [late/lathe] 5 {ERPGS} exhibit? 6 MR. GOLDMAN: [12/twelve]. 7 ATTORNEY 1: 8 ATTORNEY 1: [12/Twelve] {TEUFRPBLGTS} 9 yes. 10 Q. Do you know what [that/this a] 11 document is? 12 A. [I mean/I'm/I am] pretty sure 13 [in/inch/I know/I knew]. 14 Q. [What's/What is] it? 15 A. It looks like it was part of 16 the report that was sent to the FDA in 17 preparation [forth/for the/fourth] advisory 18 committee met [go/\ing]. 19 Q. Can you read the title to me? 20 A. Development of is it a {TEUS} 21 {SKAL} methodology. 22 Q. [Is that/Is this a] 23 [is that/is this a] {TEUS} calendar methodology, 24 the methodology that was used to do the is it a Page 235 1 {TEUS} calendar analysis within the b m [j/j] 2 article? 3 A. [It's/Its] part of this. 4 Q. If I wanted to {RAOEU/PAOETD} 5 [and/on] get the same results [that/this a] are 6 reached in the b m [j/j] article, would I use the 7 met {TKOLG} [that/this a] is described in this do 8 you mean? 9 A. There are many met {TKOLGS} 10 described in this document. 11 Q. Okay. ? 12 Q. Is there one that was used with 13 the b m [j/j] article or were they all used with 14 the b m [j/j] {ARPBLGTSDZ} they were not all used 15 with the b m [j/j] article? 16 Q. Could you tell me which 17 {AOEULT} else were used with the b m [j/j] 18 article? 19 A. . 20 A. [I would/I'd] need to 21 [seat/see the/receipt] b m [j/j] article. 22 MR. GOLDMAN: 23 MR. GOLDMAN: [Objecting/okay]. 24 A. The is it a cities {SKAL} Page 236 1 method used in the b m [j/j] [a/an] {ARBL} 2 partially described in item [9/nine]. 3 Q. How could you {KRAOE} 4 {KWRAEUTD} [a/an] [mother/more] completes or 5 [add/ad] to item [numb/number] [9/nine] to 6 describe [mother/more] completely the is it a 7 [is/\S] {TEUS/SKAL} [medical/med] {THOD} used 8 in the {TKPWFPLT} m [j/j] article? 9 A. The b m [j/j] article [and/on] 10 [it's/its] sufficient enough to de{SAOEUFR} what 11 was done [what/when a] methods was used. 12 Q. [So/Sew] if I wanted to repeat 13 the method used in the b m [j/j] article, I could 14 use read the b m [j/j] article? 15 A. That's correct. 16 ATTORNEY 1: 17 ATTORNEY 1: I have no further 18 [questions/question is] {KHREPL/TKHREPL} I have 19 no [questions/question is]. 20 MS. LAWS: We [we will/we'll/wheel] 21 reserve our [questions/question is] 22 Page 237