0001 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF WYOMING 2 - - - 3 TOBIN, et al, : NO. 00CV0025 4 Plaintiffs : : 5 vs. : : 6 SMITHKLINE BEECHAM, : Defendant : 7 - - - 8 Videotaped Deposition of BONNIE 9 S. ROSSELLO, taken pursuant to notice, at 10 One Commerce Square, Suite 2600, Philadelphia, 11 Pennsylvania, on Thursday, October 19, 2000, 12 beginning at approximately 12:45 p.m., before 13 Jeanne Hoyt-Christian, Court Reporter-Notary 14 Public, there being present. 15 - - - 16 APPEARANCES: 17 VICKERY & WALDNER, LLP 18 BY: ANDY VICKERY, ESQUIRE 2929 Allen Parkway, Suite 2410 19 Houston, Texas 77019 Phone: (713) 526-1100 20 Representing the Plaintiffs 21 LAW OFFICE OF VINCE D. NGUYEN BY: DONALD J. FARBER, ESQUIRE 22 2858 Stevens Creek Boulevard San Jose, California 95128 23 Phone: (415) 491-0674 Representing the Plaintiffs 24 25 0002 1 APPEARANCES CONTINUED: 2 PREUSS SHANAGHER ZVOLEFF & ZIMMER 3 BY: CHARLES F. PREUSS, ESQUIRE 4 AND THOMAS W. PULLIAM, JR., ESQUIRE 5 225 Bush Street, 15th Floor San Francisco, California 6 94104 Phone: (415) 397-1730 7 Representing SmithKline Beecham Company 8 STOEL, RIVES, LLP 9 BY: JOHN A. ANDERSON, ESQUIRE 201 S. Main Street, Suite 1100 10 Salt Lake City, Utah 84111 Phone: (801) 578-6930 11 Representing SmithKline Beecham Company 12 SMITHKLINE BEECHAM 13 BY: ANDREA L. PARRY, ESQUIRE Senior Counsel 14 One Franklin Plaza Philadelphia, Pennsylvania 15 19101 Phone: (215) 751-7022 16 Representing SmithKline Beecham Company 17 18 19 20 21 22 23 24 25 0003 1 I N D E X 2 - - - 3 WITNESS EXAMINATION 4 BONNIE S. ROSSELLO 5 BY MR. VICKERY 4, 128 6 BY MR. FARBER 59 7 8 9 E X H I B I T S 10 - - - 11 12 NUMBER DESCRIPTION PAGE MARKED 13 21 Resume. . . . . . . . . . . . 6 14 22 Product Information Document. 32 15 23 Letter to Dr. Donnelly. . . . 51 16 24 Letter to Mr. Dr. Brennan. . . 54 17 25 Fax to Dr. Brennan. . . . . . 79 18 26 Letter to Dr. Powell. . . . . 82 19 27 Letter to Dr. Stockbridge. . 105 20 28 Letter to Dr. Stockbridge. . 105 21 22 23 24 25 0004 1 THE VIDEO TAPE OPERATOR: 2 We're on the video record. Today's date is 3 October 19, 2000. The deponent is Bonnie 4 Rossello. The time is 12:45. The court 5 reporter will now swear in the witness. 6 - - - 7 BONNIE S. ROSSELLO, after 8 having been first duly sworn, was examined and 9 testified as follows: 10 - - - 11 EXAMINATION 12 - - - 13 BY MR. VICKERY: 14 Q. State your name, please. 15 A. Bonnie S. Rossello. 16 Q. Ms. Rossello, my name is Andy Vickery. 17 I met you briefly before the deposition. I'm 18 a lawyer from Houston, Texas. I'm handling a 19 lawsuit against your company, and we're here 20 to take your deposition today with regard to 21 that. 22 Do you understand that? 23 A. I do. 24 Q. Have you ever had a deposition taken 25 before? 0005 1 A. No. 2 Q. Well, you are in luck, because you have 3 got the softest bunch of lawyers taking your 4 deposition that you could ever have. At least 5 half of us. I won't speak for him. 6 A couple of ground rules. 7 One is, we need verbal responses. This lady 8 right here is very talented. She will get 9 down everything we say, as long as we don't 10 talk at the same time, and as long as we give 11 verbal responses. 12 A. I understand. 13 Q. So a shake of the head or un-huh, 14 uh-huh, that sort of thing -- the shake of the 15 head actually comes through fine on the video, 16 but not very well on the transcript. 17 Secondly, I will try to 18 make questions clear and will try to wait for 19 you to finish an answer before I start another 20 one. If you will do the same, even though 21 halfway through a question -- I know I am from 22 the South, and I may speak a little slow, but 23 halfway through the question, you may know 24 what I'm asking, and you may want to be 25 answering. Just wait, okay? Until I finish 0006 1 the question. 2 And finally, as I told you 3 before we started on the record here, this is 4 not an endurance contest. If you need to take 5 a break for your personal comfort or any other 6 reason at any time, you tell me, and we will 7 do that, okay? 8 A. Okay. 9 Q. Now, I have been given a copy of a 10 resume, and we are going to mark one as 11 whatever our next exhibit is. 12 - - - 13 (Whereupon the court 14 reporter marked document as Exhibit 21 for 15 identification.) 16 - - - 17 BY MR. VICKERY: 18 Q. This is Exhibit 21. Is this your CV or 19 resume? 20 A. This is. 21 Q. Is it something you prepared just for us 22 today or is it something that you keep on hand 23 all the time? 24 A. I prepared it for you. 25 Q. Is there another form that you keep 0007 1 somewhere else? 2 A. No. 3 Q. You have got job security, I guess. The 4 folks at SmithKline, I'm sure, are glad to 5 hear you don't keep one updated. 6 I see you have been with 7 them since '87? 8 A. Since the end of '82. 9 Q. Oh, okay, then I didn't understand. 10 What did you do from '82 to 11 '87? 12 A. I had a series of jobs, starting as the 13 media manager, and then communications 14 specialist for a number of different products. 15 Q. What did you do from the time you 16 graduated from college in '76 until '82, when 17 you went to work for SmithKline Beecham? 18 A. I worked for four years in a publishing 19 company and two years for an advertising 20 agency. 21 Q. How did you get attracted to this big 22 pharmaceutical company? 23 A. My client at this ad agency was 24 SmithKline Beecham. 25 Q. And in the 18 years you have been there, 0008 1 obviously, you have done very well, you are 2 now the vice-president and group director for 3 neuroscience and anti-arthritic business unit? 4 A. Yes. 5 Q. And have been, it looks like, for a 6 couple of years? 7 A. Yes. 8 Q. Looking at the resume, it looks like you 9 joined the Paxil section of the company after 10 it was approved; is that true, or were you 11 there for the launch? 12 A. I was there for the launch in February 13 of '93. 14 Q. Oh, I see. It was launched in February 15 '93? 16 A. Yes. 17 Q. Where was it launched? 18 A. In the US, it was launched, in February 19 of '93. 20 Q. I'm sorry. That was an unclear 21 question. When I say where, I assume you all 22 had a big shindig somewhere. 23 A. We did not. It was launched through a 24 series of regional sales meetings. 25 Q. How long before the launch did you join 0009 1 that team? 2 A. Two months before the launch. 3 Q. Did they ask you to join the Paxil team 4 or did you ask to be reassigned from Tagamet 5 to Paxil? 6 A. I was asked to move from Tagamet to 7 Paxil. 8 Q. Any particular reason? 9 A. I had performed well on the Tagamet 10 team, and this was a new opportunity. 11 Q. And I can tell your title here was 12 product director and senior product manager 13 for Paxil from '93 to '98. 14 Did all of your business 15 efforts in that five-year period focus on 16 Paxil? 17 A. Yes. 18 Q. Were you the top person in the marketing 19 end of the company with respect to Paxil? 20 A. Not initially. 21 Q. Who was initially? 22 A. Kathy Sohn. 23 Q. Kathy who? 24 A. Sohn, S-O-H-N. 25 Q. S-O-H-N? 0010 1 A. Correct. 2 Q. And what does Ms. Sohn do now? 3 A. She runs worldwide business development 4 for the consumer division. 5 Q. When did she move out of the Paxil 6 unit? 7 A. In May of '93. 8 Q. And were you then the senior marketing 9 person from that point forward? 10 A. Yes. 11 Q. A very important job, isn't it? 12 A. Yes. 13 Q. Was part of your job responsibility to 14 forecast sales? 15 A. Yes. 16 Q. How do you go about doing that with a 17 pharmaceutical prescription drug like Paxil? 18 A. Working in tantum with marketing 19 research to look at the number of 20 antidepressant prescriptions that were being 21 prescribed, and then anticipating based on, 22 again, marketing research findings, what the 23 uptake would be of our product. 24 Q. Is part of that process figuring out 25 what kind of market penetration or market 0011 1 share you would get? 2 A. Yes. 3 Q. And what kind of factors affect the 4 expected market penetration or share? 5 A. Our ability to communicate and reach the 6 physicians who are most likely to write and 7 prescribe antidepressants. 8 Q. Now, did you believe that some of the 9 business you would get would be derived from 10 physicians writing prescriptions for Paxil, 11 instead of other SSRI drugs? 12 A. Yes. 13 Q. Did you think that some of the business 14 that you would get would be from them writing 15 prescriptions for Paxil, instead of tricyclic 16 antidepressants or other kinds of non-SSRI 17 antidepressants? 18 A. Yes. 19 Q. And did you think that some of the 20 projections would be based upon physicians 21 being more -- oh, I don't know, more inclined 22 to diagnose depression and prescribe Paxil for 23 it? 24 A. I'm not sure what you mean. 25 Q. In other words, in the increase in the 0012 1 rate or frequency with which physicians made a 2 diagnosis of depression, is that -- did you 3 expect to gain part of your market share in 4 that way? 5 A. Part of the prescriptions that we were 6 forecasting, yes, we expected it to be linked 7 with the increase in use of antidepressants. 8 Q. Now, as part of your market research, 9 were you able to determine the prescribing 10 patterns of individual physicians in 11 individual states or territories? 12 A. The prescribing patterns? We were able 13 to establish prescribing levels for 14 physicians. What do you mean by profiles? 15 Q. Well, in other words, let's say we are 16 in Cheyenne, Wyoming. Your market research is 17 such that you know which physicians in 18 Cheyenne, Wyoming are prescribing what drugs, 19 don't you? 20 A. We have -- I have information in general 21 about what physicians prescribe. I, myself, 22 don't have access to information about 23 individual physicians. That may exist. You 24 would have to ask somebody in marketing 25 research. 0013 1 Q. I know. I wouldn't expect, at your 2 level, you would, but within your company, 3 your marketing people can actually figure out, 4 in other words, how many prescriptions Doctor 5 Jones in Cheyenne, Wyoming is writing for 6 antidepressants? That's the kind of 7 information that you all can get, isn't it? 8 A. We may. The sales force or sales 9 management may have that information. I don't 10 have that information. I'm sorry. I just 11 don't know. 12 Q. How many different regional locations 13 were involved in the launch? 14 A. There were probably 16 or 17, to the 15 best of my recollection. 16 Q. How many of those meetings did you 17 personally attend? 18 A. I don't remember. Probably four or 19 five. 20 Q. And the same question with regard to Ms. 21 Sohn. 22 A. I don't know. 23 Q. Did you know, at the time that you 24 joined the Paxil team, that you would be 25 transitioning into her job? 0014 1 A. No. 2 Q. So you were promoted what, three, four 3 months into it? 4 A. It was about six months after I joined 5 the team. 6 Q. Okay, when did you get there, in 7 December '92? 8 A. Yes. 9 Q. And then she left in May of '93, and you 10 were promoted? 11 A. Yes. Actually, I wasn't promoted. I 12 assumed responsibility. I had the same title. 13 Q. Oh, so they gave you the same pay, but 14 with increased responsibility. I see. 15 Ms. Rossello, at these 16 regional launches, was there some kind of a -- 17 I don't know -- a speech or pep talk, if you 18 will, from somebody at headquarters to 19 encourage the salesmen to get enthusiastic 20 about going out and promoting Paxil? 21 A. There was a talk about -- yes, from a 22 central person from headquarters about the 23 drug. 24 Q. Was that presented on video tape? 25 A. There were video tapes. I don't recall 0015 1 that there was a video tape from somebody from 2 central. 3 Q. Did the same person from central come 4 out and give the pep talk every time? 5 A. No. 6 Q. That's what made me think it is video, 7 if it is 16 or 17 locations. 8 A. Yes, there were a number of people from 9 the team, and the business unit had -- there 10 was a fair number of people that had -- that 11 gave that presentation at that launch 12 meetings. 13 Q. Was it the same speech or script that 14 was just given by different people in 15 different locations? 16 A. It was -- the slides were probably 17 similar. 18 Q. Did you give any of those speeches? 19 A. I did. 20 Q. And so there were a set of slides that 21 you used sort of as the framework, if you 22 will, for your speech or presentation? 23 A. I believe. It has been a while. This 24 was now seven years ago. I'm struggling to 25 remember what I used during that talk. 0016 1 Q. Sure. 2 Can you tell me what, if 3 anything, sticks in your mind now as kind of 4 the high point or selling point that you were 5 trying to convey to the sales people? 6 A. Yes, that this was a remarkable drug 7 that had been very well tested, that we 8 thought had the potential to help a lot of 9 people who were suffering from depression. 10 Q. Okay, now, the same would have been 11 said, I'm sure, by the folks at Lilly about 12 Prozac and at Pfizer about Zoloft. 13 So what did you tell your 14 sales people to help them compete against 15 those other drugs within the SSRI class of 16 drugs? 17 A. We really focused on the very specific 18 data that we had about our drug. There were 19 no head to head studies, so there were -- 20 there was not a lot of data to compare. We 21 really focused on the efficacy data that we 22 had and the potential that we got. 23 Q. Did you focus on the fact that Paxil has 24 a substantially shorter half-life than Prozac? 25 A. As part of a pharmacokinetic profile 0017 1 comparison, we may have. 2 Q. I mean that was a big selling point, 3 wasn't it? 4 A. I don't know that it was a big selling 5 point. I honestly don't remember where that 6 played in the presentation. I would have to 7 see the document to be reminded about the 8 prominence of the half-life message in the 9 presentation. 10 Q. How about the fact that Paxil does not 11 have a psychoactive metabolite? Was that a 12 selling point? 13 A. That was part of the information that we 14 communicated, yes, to the sales force. 15 Q. Did you have a set of Q&A's that were 16 disseminated to the sales people? 17 A. We may have. I don't recall. There may 18 have been a Q&A. With regard to what? 19 Q. Well, with regard to Paxil. In other 20 words, questions that they would anticipate 21 that would frequently be asked by doctors, and 22 you know, suggested responses that they could 23 give those doctors? 24 A. I don't recall. I recall that there was 25 a Q&A that was developed for physicians. 0018 1 Q. When you say for physicians, you mean 2 one that the sales people would use in 3 answering physicians' inquiries? 4 A. No, for the sales representatives to 5 hand over to the physicians. 6 Q. Oh, to actually hand them out a written 7 Q&A? 8 A. As I recall, yes. 9 Q. What role, if any, did you have in the 10 development of the promotional materials 11 used? And I'm focusing right now back at the 12 time of the launch. 13 A. I played a role, yes, I played a role in 14 working with medical and regulatory to develop 15 those materials. 16 Q. Is one of the things that you did, was 17 it to develop a sort of a slick four-color 18 patient handout brochure? 19 A. We developed a patient brochure. 20 Q. And what's that to be used for? 21 A. I don't recall that it was slick. 22 Q. Oh, it wasn't slick? I have seen some 23 of them. They looked pretty good. 24 A. I'm sorry. Could you -- 25 Q. When I say slick, I just mean, you know, 0019 1 it is printed on sort of glossy color paper, 2 high quality paper, in four-color process. 3 MR. PREUSS: We will accept 4 that substitution. 5 MR. FARBER: Oh, that 6 definition. 7 BY MR. VICKERY: 8 Q. That's what I mean. And that's what you 9 had. I mean, it was a high quality paper with 10 four-color printing that was meant to catch 11 the eye, wasn't it? 12 A. It was meant to be made available for 13 physicians to provide to their patients who 14 they felt were appropriate for the treatment 15 of depression with Paxil. 16 Q. Do you recall anything with respect to 17 the launch about suicide or the risk of 18 suicide? 19 A. I recall that there was a statement in 20 the labeling that would have been reviewed, as 21 our full contents of the labeling would have 22 been reviewed during the training process with 23 the sales representatives. 24 Q. Okay, I understand that. I'm not 25 talking about the labeling or package insert. 0020 1 What I'm really talking about is either a Q&A 2 or something given in a speech, so that when 3 you had the attention of the sales force at 4 the time of the launch, you say, now, look, 5 you may get some questions about whether our 6 drug causes suicide, and this is how we 7 suggest you respond. 8 Do you remember anything of 9 that ilk? 10 A. I do not. 11 Q. Do you remember anything along the lines 12 of, if we tell doctors that our drug has a 13 shorter half-life and an inactive metabolite, 14 then we are going to have a competitive 15 advantage over Prozac, because they are going 16 to snap to the realization that, hey, maybe 17 this drug doesn't cause suicide to the degree 18 that Prozac does? 19 A. No, that was not a message. 20 Q. What role have you had with respect to 21 training your sales force? 22 A. The role we played is to help with the 23 training, sales training department to develop 24 materials with medical and regulatory. 25 Q. Do you know whether or not any of those 0021 1 materials contain standard operating 2 procedures or Q&A's for answering physician 3 inquiries about potential risks of suicide or 4 violence? 5 A. The sales training would train our sales 6 representatives, if a question was raised by a 7 physician about suicide, to refer to the 8 labeling, and if that didn't adequately answer 9 the physician's question, they would be 10 instructed then to contact the product 11 information department. 12 Q. So are you saying that the sales people 13 would never try to give a physician a 14 substantive answer themselves? In other 15 words, they would say, look at the label, and 16 if the label doesn't do it, call somebody at 17 headquarters who can answer it? 18 A. That's how they would be trained. 19 Whether or not we would have a sales rep 20 that's done that, I don't know. There is 21 3,000. 22 Q. If they follow their training? 23 A. If they follow their training, yes. 24 Q. Incidentally, do you call your sales 25 people detail men or -- 0022 1 A. We call them sales consultants. 2 Q. They don't like that term detail men, do 3 they? 4 A. I don't know. 5 Q. You have heard the term before, haven't 6 you? 7 A. I have. 8 Q. And do you call the process of providing 9 information to a physician detailing? 10 A. We do. We have. 11 Q. What are reminder ads? 12 A. We characterize a reminder ad as a 13 one-page ad with a brief summary. 14 Q. Isn't anything that kind of reminds 15 people of the name Paxil within the FDA's 16 categorization of reminder ads? 17 A. That would be a regulatory definition. 18 A marketing definition of a reminder ad is a 19 one-page advertisement. 20 Q. You all hand out things like mugs and 21 prescription tablets and pens and other things 22 that have your trade name Paxil on them, don't 23 you? 24 A. Yes. 25 Q. I mean you equip your sales reps with 0023 1 those items to hand out to doctors to remind 2 them of Paxil when they are prescribing, 3 right? 4 A. Yes, we distribute those items. 5 Q. Can you give me a ballpark estimate for 6 the amount of money that SmithKline Beecham 7 spends every year on those kinds of ads? 8 A. For all products? 9 Q. No, ma'am, just Paxil. 10 A. I would be -- it would be a guess. 11 Q. Just a ballpark. I understand it is not 12 precise. 13 A. Somewhere between 500,000 and a 14 million. 15 Q. Is that just in this country or 16 worldwide? 17 A. That would be just in the US. 18 Q. Do you have any mechanism for 19 determining the effectiveness of that mode of 20 advertising? 21 A. No. 22 Q. I guess experience must suggest to the 23 company over the years that it pays off or 24 they wouldn't spend that money every year to 25 do it? 0024 1 A. It is a common industry practice. 2 Q. Do you know whether or not, under FDA 3 regulations, your company would be prohibited 4 from using that kind of advertising if they 5 had a black box warning on the drug? 6 A. I don't know. 7 Q. Are you familiar with any of your drugs 8 that do have black box warnings? 9 A. No. 10 Q. Do you know what I'm talking about when 11 I say a black box warning? 12 A. I do. 13 Q. What is one? 14 A. I have a rough idea. I'm not a 15 regulatory expert, but it is a warnings 16 statement that highlights a serious safety 17 issue. 18 Q. And is it called a black box warning, 19 because, in fact, on the label, it appears 20 inside of a little black box? 21 A. I don't know why it is called black 22 box. That's probably a good guess. 23 Q. That would be a real good guess. Okay. 24 What role, if any, did you 25 have in either thinking of or pursuing the 0025 1 social phobia indication for Paxil? 2 A. That was a medical focus, looking for -- 3 it was part of the clinical plan that included 4 evaluating Paxil for anxiety disorders. 5 Q. Well, I see here on your resume, Exhibit 6 21, it says, a business plan for Paxil, 7 introduction of new indications? 8 A. Yes. 9 Q. Now, by new indications, what you are 10 talking about is something for which the FDA 11 approves marketing? 12 A. Yes. 13 Q. Which would include social phobia, 14 right? 15 A. Correct. 16 Q. Would include obsessive compulsive 17 disorder? 18 A. Yes, OCD, yes. 19 Q. Can you tell me any other approved 20 indications that your company has for Paxil? 21 A. Panic disorder and depression. 22 Q. Don't answer this, if it is a trade 23 secret, but can you tell me, are you also 24 pursuing indications for PTSD or PMS or any of 25 the things that some of the other SSRI's have 0026 1 received indications for? 2 A. We are evaluating Paxil in both those 3 indications. 4 Q. How do you, as a marketing person, with 5 experience in forecasting and projections, 6 figure out the anticipated economic 7 consequences of getting a new indication? 8 A. It is done with marketing research, 9 based on information from the literature, see 10 how many people are suffering from the 11 disorder, and basically building an 12 epidemiological based model. 13 Q. Is that kind of marketing research done 14 in-house? 15 A. Yes, in part. 16 Q. And is it done now by people who report 17 to you, either directly or through other 18 folks? 19 A. No, different department. 20 Q. What department is it in? 21 A. Marketing analytics. 22 Q. They are able to try and give a good 23 handle on what dollar benefit the company 24 could expect from any new indication, aren't 25 they? 0027 1 A. They are able to, yes, associate an 2 economic benefit with expected prescriptions. 3 Q. Your resume reflects that in the period 4 from '93 to '98, one of the things you did was 5 assessment of life cycle opportunities. 6 What is that? 7 A. That's evaluating new formulations, line 8 extensions. 9 Q. Line extensions? 10 A. Yes. 11 Q. What is that? 12 A. Such as an oral suspension, different 13 strength. 14 Q. All relating to Paxil, but just in 15 different ways of delivering it? 16 A. Yes. 17 Q. I see. 18 Then maybe you are the 19 person for me to ask this question. Do you 20 know what -- do you know whether your company 21 is trying to market a purer version of Paxil? 22 A. I'm not the person to ask that 23 question. I'm not even sure what that means, 24 a purer version. 25 Q. Well, I will find somebody to answer 0028 1 it. 2 Your resume says that you 3 represented the US position in Worldwide 4 Neuroscience Strategic Team. What is the 5 Worldwide Neuroscience Strategic Team? 6 A. They are the product managers from the 7 various countries around the world that meet 8 once a year. 9 Q. In how many countries is Paroxetine 10 licensed? 11 A. I don't know the answer to that. 12 Q. Can you tell me, of all of the sales of 13 this drug worldwide, what percentage come from 14 the United States? 15 A. Roughly 70 percent. 16 Q. Your resume reflects that you did 17 management of Phase IV clinical program and 18 advisory boards. 19 What are those? 20 A. The Phase IV plans reflect the clinical 21 studies that are done for Paxil in label, 22 within label indications. So just, you know, 23 further exploring -- I'm trying to think of an 24 example. One is not coming to mind. 25 Q. Let me see if I can think of one for 0029 1 you. 2 Depression is within 3 labeling, right? 4 A. Yes, so maybe depression within a 5 certain population. 6 Q. That's the exact example I was going to 7 use, depression within an aged population, 8 maybe, would be a Phase IV study? 9 A. Yes. 10 Q. Now, how about those studies that search 11 out a new indication? 12 A. No, those would be conducted by clinical 13 development, by R&D. 14 Q. And are those Phase III studies? 15 A. Yes. 16 Q. You were promoted to vice-president two 17 years ago, right? 18 A. I was promoted to vice-president in 19 February of '99. My job before that was group 20 director, but the responsibilities were 21 essentially the same, which is why I grouped 22 them. 23 Q. It looks like from your resume that you 24 now have responsibilities for other drugs in 25 addition to Paxil; true? 0030 1 A. Yes. 2 Q. What is Relafen? 3 A. It is a non-steroidal, anti-inflammatory 4 agent. 5 Q. What is Requip? 6 A. It is a dopamine agonist for Parkinson's 7 disease. 8 Q. Now, when it says new CNS and 9 anti-arthritic compounds, new CNS would be new 10 central nervous system compounds that were 11 currently in Phase II and Phase III? 12 A. Yes. 13 Q. So if, for example, there was some 14 compound that would represent the next 15 generation of antidepressants, and it was in 16 Phase II or Phase III studies now, that would 17 fall under your bailiwick? 18 A. No, that would be part of -- I have 19 input or I sit on a committee to view, my job 20 is really to be aware of those products, 21 because, ultimately, if they come to market, 22 they would move into my unit, but they are the 23 responsibility of new product development. 24 Q. And it is my understanding and belief 25 that if there are such things out there, that 0031 1 those would be very jealously guarded trade 2 secrets; is that true? 3 A. Yes. 4 Q. All right, then I won't ask you about 5 that. 6 One of the documents that's 7 been provided to me, which I will mark in a 8 minute, is a document on the Product 9 Information Department. 10 What is that? 11 A. That's a department that reports to 12 regulatory that's staffed by people with 13 pharmacy backgrounds, who are responsible for 14 responding to queries from physicians. 15 Q. Do most queries come by telephone, 16 e-mail, snail-mail or what? 17 A. I don't know. I don't know what the mix 18 is. 19 Q. I'm sorry? 20 A. I just said, I'm sorry, I said I don't 21 know what the mix is. 22 Q. Is this department under your 23 supervision now? 24 A. No. 25 Q. Why did you choose to read this document 0032 1 in preparation of the deposition? 2 A. One of the Interrogatories focused on 3 how we train the sales representatives to 4 respond to the questions. 5 Q. I see. Let's go ahead and mark that 6 document. 7 - - - 8 (Whereupon the court 9 reporter marked document as Exhibit 22 for 10 identification.) 11 - - - 12 BY MR. VICKERY: 13 Q. Would you identify Exhibit 22 for me, 14 please, ma'am? 15 A. This is a document entitled SB Product 16 Information Department. 17 Q. And can you tell me what it is? Is it 18 like their SOP, their -- 19 A. Actually, this document was designed to 20 give to the sales representatives to give them 21 an understanding of what the role of product 22 information is and what the SOP is or the 23 procedure for the representatives to follow 24 when they have an inquiry for one of their 25 physicians. 0033 1 Q. Let's see if we can use an example. 2 Let's say I'm a sales rep for SKB, and I'm 3 calling on Doctor Jones in Cheyenne, Wyoming, 4 and he says, Mr. Vickery, you know, I have 5 heard that SSRI drugs can treat bulimia. Can 6 I prescribe it for bulimia? 7 What would my obligation as 8 an SKB salesperson be? 9 A. To say that Paxil is not indicated for 10 bulimia. If you would like to find out any 11 information about Paxil in the use of bulimia, 12 you can contact the Product Information 13 Department. 14 Q. So then, if he placed a telephone call 15 to this safe haven called a Product 16 Information Department, what would Doctor 17 Jones be told? 18 A. I'm not sure what's on the records or I 19 don't know what the data look like for 20 bulimia. 21 Q. So if, for example, there was an ongoing 22 trial for bulimia, and if the preliminary 23 trials had looked pretty good, then those 24 people in the product information department 25 could tell him, could just say, you know, we 0034 1 haven't got an approved indication from the 2 FDA, but we are studying this, and so far, it 3 looks pretty good? 4 A. I'm honestly not sure what they would 5 say about that particular topic. 6 Q. With respect to this document, let me 7 make sure our record is clear, I have been 8 advised by counsel that the missing pages 9 relate to other drugs; is that right? 10 A. Correct. 11 Q. Let's look together then at the page for 12 Paxil. 13 A. Okay. 14 Q. Let me choose an example here. Well, 15 one topic is clinical comparison of Paxil to 16 Prozac. And under the contents, it says, data 17 from several comparative trials in depression, 18 essentially comparable response. 19 Is that side, that column, 20 the gist of the response that the people in 21 the Product Information Department give to a 22 physician? 23 A. That's roughly the content that would be 24 included in the letter. 25 Q. So if a doctor calls in and asks about 0035 1 the difference, all he is going to be told is 2 that these drugs work about as well as one 3 another? 4 A. I think he would be provided with the 5 details of the study, but I'm not sure about 6 that. I have not seen that particular letter 7 from Product Information. 8 Q. The last entry here is effects on 9 norepinephrine. 10 Do you know what 11 norepinephrine is? 12 A. My general understanding is that it is a 13 neurotransmitter. 14 Q. It says Nemeroff data. Do you know what 15 that is? 16 A. Doctor Nemeroff is the author or the 17 investigator of the study. 18 Q. The clinical investigator of a study on 19 whether or not -- 20 A. Looking at Paxil's effect on 21 Norepinephrine. 22 Q. Is that a published study? 23 A. There may be a study. I'm not sure. 24 Q. Is this the study that he was 25 commissioned to do on behalf of SmithKline 0036 1 Beecham? 2 A. That would be better directed at Doctor 3 Wheadon. 4 Q. I don't think we are going to get him 5 back. I think he has had enough of us. 6 Do you know Doctor 7 Nemeroff? 8 A. I do. 9 Q. He is down in Atlanta, right? 10 A. Yes. 11 Q. And he is a very well-known 12 psychopharmacologist? 13 A. Yes. 14 Q. Has he done a lot of work for your 15 company? 16 A. He has been -- done work as an advisory 17 board member and some studies. 18 Q. How frequent have you had contact with 19 him? 20 A. We have two advisory boards a year, and 21 I probably speak to Doctor Nemeroff maybe once 22 a month. 23 Q. Once a month? In what context do you 24 have to speak to him? 25 A. Various and assorted reasons. I'm 0037 1 generally asking questions about study data or 2 -- I know him. I have known him since the 3 death of his son, and I frequently called to 4 see how he is doing since then. 5 Q. Have you or to your knowledge anyone 6 else at SmithKline Beecham had any 7 conversation with Doctor Nemeroff about this 8 lawsuit or these kinds of lawsuits? 9 A. To the best of my knowledge, no. 10 Q. Have you ever had any conversation with 11 Doctor Nemeroff about the issue of whether 12 SSRI drugs may or may not cause suicide or 13 violence in some people? 14 A. I may have in the past. 15 Q. Do you recall what he said about it? 16 A. He referenced a meta analysis that had 17 been conducted by Lilly, I believe. 18 Q. Have you had any discussions with him 19 concerning the willingness of physicians to 20 testify? 21 A. No. 22 Q. Now, as an advisory board member, is he 23 regularly compensated in some way by 24 SmithKline Beecham? 25 A. Yes. 0038 1 Q. I will tell you, quite frankly, the 2 reason I asked these is because I have reason 3 to believe that Doctor Nemeroff discouraged 4 someone from consorting with folks like me, 5 and I am concerned as to why he would do 6 that. 7 A. I don't have any background on that at 8 all. 9 Q. All right. 10 Now, what is the -- if you 11 know, when it says the effects on 12 Norepinephrine, the in vitro data from the 13 Owens article? Can you tell me whether Paxil 14 affects the Norepinephrine system? 15 A. There is some evidence, but again, I'm 16 not a scientist. There seems to be some 17 evidence that at higher doses, this may be the 18 case. 19 Q. How are you all doing in your marketing 20 efforts for Paxil? 21 A. How do you mean? 22 Q. Well, is it still the number three 23 selling SSRI in this country? 24 A. It is really very closely bunched with 25 Prozac and Zoloft. I think, at this point, on 0039 1 the basis of total prescriptions, it is the 2 second most widely prescribed. 3 Q. How about in dollar volume? Is it now 4 for the years, say, '98 and '99 and projected 5 for the year 2000 over two billion dollars 6 each year? 7 A. It is now over two billion for 8 worldwide, not for the US. 9 Q. Right. I think you told me earlier, the 10 US was 70 percent of the market? 11 A. Yes. 12 Q. Are the profit margins greater in the US 13 than in other countries? 14 A. I don't know that. 15 Q. And just so I'm clear, to your 16 knowledge, there no standard instructions, 17 standard training, nothing whatsoever for your 18 sales people who interact with physicians with 19 respect to suicide? 20 A. To the best of my knowledge, there is 21 not. 22 Q. Are the sales people compensated on a 23 commission basis? 24 A. Yes. 25 Q. So they have a quota? 0040 1 A. A combination of salary and bonus. 2 Q. And the bonus is affected by the 3 prescribing practices of their doctors and 4 their territory? 5 A. Their bonus is based on market share 6 objectives. 7 Q. Is one of the tools that they have to 8 use professional samples? 9 A. Yes, they distribute samples. 10 Q. How does that work? I mean, what is 11 there about them having samples that you 12 believe helps in the marketing effort? 13 A. Physicians, when they prescribe, I 14 think, often, until they are able to establish 15 whether or not the drug will be effective or 16 tolerated, like to provide patients with a 17 sample of the product. 18 Q. So in other words, it kind of gets the 19 patient started and makes sure that they 20 tolerate the drug well? 21 A. That's one of the reasons, yes. 22 Q. Is patient -- do you know what patient 23 compliance is? 24 A. My understanding is the length of time 25 that the patient takes the drug. 0041 1 Q. And what, if anything, does SmithKline 2 Beecham do to try to encourage patients to be 3 compliant on Paxil for, you know, at least 4 four to six weeks? 5 A. We provide information to the physician, 6 if he chooses -- that's his individual 7 decision, if he chooses to pass that along to 8 the patient, that highlights the benefits of 9 complying with the physician's recommendation 10 about the course of therapy. 11 Q. Is the information you provide to the 12 physician in the form of an intended patient 13 handout? 14 A. Yes. 15 Q. What's that called? 16 A. Patient information brochure. 17 Q. Is there some acronym by which you call 18 this program? 19 A. Are you talking about the brochures that 20 we hand to -- that we supply physicians with? 21 Q. I'm talking about the patient compliance 22 program. I mean, for example, I can tell you, 23 over at Pfizer, they are very militaristic 24 over there, they use lots of acronyms, and 25 they have the Rhythms program, and that's 0042 1 their patient information and compliance 2 program, which is designed to encourage people 3 to stay on Zoloft, hang in there, even if they 4 are having adverse effects. 5 You all have some kind of 6 similar program, don't you? 7 A. We had a program, and I'm not sure it is 8 still even in place. It has been two years 9 since I have had day-to-day responsibility, 10 but we had a program called Expressions. 11 Q. Expressions? 12 A. Yes. 13 Q. And what was Expressions? Same sort of 14 thing? 15 A. It was a group of materials that 16 included a video tape, narrated by Kathy 17 Cronkite, describing depression, the illness, 18 and some patient information about Paxil. 19 Q. Again, in the form of patient handouts? 20 A. Yes. 21 Q. Do you also tailor -- 22 A. And that was provided to physicians, not 23 directly to consumers. 24 Q. Right. You don't have the 25 doctor/patient relationship. You rely on the 0043 1 physician to give the patient the information 2 that you have provided the physician for that 3 purpose? 4 A. That's right, yes. 5 Q. And was it the idea with the video that 6 it is something that the patient would see in 7 the physician's office? 8 A. That would have been up to the 9 physician. We developed it for -- they could 10 use it as they saw appropriate, the physician. 11 Q. I mean, they weren't given enough videos 12 that they could give one to all their 13 patients, were they? 14 A. I don't remember. 15 Q. Do you remember whether or not, in the 16 Expressions program, it encouraged patients to 17 sort of hang in there, even if they were 18 having adverse effects early on? 19 A. I honestly don't remember that. That 20 would be information that we would expect the 21 physician to convey to a patient. 22 Q. Ms. Rossello, the world with respect to 23 advertising of pharmaceuticals changed fairly 24 dramatically within the last few years, hasn't 25 it? 0044 1 A. In what sense? 2 Q. You all can do direct to consumer 3 advertising now, can't you? 4 A. Yes. 5 Q. And don't you have a very large 6 advertising budget for direct to consumer 7 advertising for Paxil? 8 A. We have a significant budget for Paxil. 9 Q. Give me an idea of approximately how 10 much money SmithKline Beecham will spend this 11 year on direct to consumer advertising. 12 A. In the ballpark -- 13 MR. PREUSS: We are talking 14 about this drug? 15 MR. VICKERY: Yes, on 16 Paxil. 17 THE WITNESS: On Paxil, 50 18 million. 19 BY MR. VICKERY: 20 Q. Okay. 21 A. Roughly. 22 Q. And how much of that 50 million is for 23 those TV ads that we see for the social phobia 24 indication of Paxil? 25 A. Versus the print? 0045 1 Q. Right. 2 A. I'm not sure. It is probably in the 3 range of 60 to 70 percent. 4 Q. 60 to 70 percent is the TV? 5 A. Yes. 6 Q. Now, in any of your advertising for 7 consumers, do you include material like what 8 was included in the Expressions program about 9 them hanging in there, if they have early 10 side-effects? 11 A. I have not seen -- there is a brochure 12 that is made available to patients who call 13 the 800 number, and I have not seen it, I'm 14 sorry. 15 Q. What's the 800 number? 16 A. I think there is an 800 number on the 17 web site. 18 Q. So in other words, anybody that wants 19 this brochure about Paxil can get it either 20 through the 800 number or the web site? 21 A. Correct. 22 Q. Have you had any contact with the media 23 about the issue of Paxil-induced violence or 24 suicide? 25 A. To the best of my knowledge, we have 0046 1 not, but that would be a question for 2 corporate communications. I would not be the 3 person that would be in touch with that. 4 Q. That's what I didn't understand. My 5 notice, sort of my outline for the deposition, 6 in Item 4-D said briefing papers or 7 instructions for responding to media 8 inquiries. 9 A. They would be prepared by corporate 10 communications. 11 MR. VICKERY: I'm going to 12 confer with him and check my notes, and I may 13 be done. 14 THE VIDEO TAPE OPERATOR: 15 Going off the video record. The time is 16 1:34. 17 THE VIDEO TAPE OPERATOR: 18 Back on the video record. The time is 1:51. 19 BY MR. VICKERY: 20 Q. Ms. Rossello, Doctor Wheadon has already 21 told us that about 70 percent of the 22 prescriptions for Paxil in this country at 23 least are written by non-psychiatrists. 24 Can you tell me why that 25 happens to be? 0047 1 A. He said 70 percent of antidepressant 2 prescriptions? 3 Q. I didn't understand him to say -- to 4 differentiate between indication. 5 Is it different -- do you 6 have different figures based on indication? 7 A. I know what the figures look like for 8 Paxil, so it is about 35 to 40 percent of the 9 prescriptions are written for -- by 10 psychiatry, and about 55 percent by primary 11 care. 12 Q. Across the board, for all indications? 13 A. I don't know it by indication. I don't 14 have that data. 15 Q. Now, has your company emphasized the 16 marketing of Paxil to non-psychiatrists? 17 A. I'm not sure what you mean, emphasize. 18 Q. If 55 percent of your market is 19 non-psychiatrists, I'm wondering if that just 20 happened by accident or did it happen because 21 you went out there specifically and targeted 22 that market? 23 A. I think it happened because there are 24 many more primary care physicians than 25 specialists. So there are, for example, 130 0048 1 primary care physicians who write 2 antidepressant scripts versus 30,000, roughly, 3 psychiatrists. 4 Q. There are 130,000 who write 5 antidepressant scripts? Is that what you are 6 saying? 7 A. Yes. 8 Q. Now -- 9 A. I mean, that's how many psychiatrists 10 and primary care guys there are. 11 Q. What is a slim-jim? 12 A. It is a sales material, sales aid that 13 we provide to our sales force, our sales 14 representatives. 15 Q. I figured that out, but I never could 16 figure out what one is. What does it look 17 like? 18 A. It is thin; hence, the expression 19 slim-jim. It is meant to be able to fit into 20 the representative's pocket. 21 Q. What is it? Is it like a card or a 22 ruler? 23 A. No, it is an eight-page brochure, 24 basically, with information about the product 25 and prescribing information. 0049 1 Q. And is some of the information that your 2 representatives give out information that's 3 specifically designed to enable primary care 4 doctors to make a diagnosis of depression? 5 A. Some of the materials -- I'm sorry? 6 Q. In other words, do your sales reps give 7 primary care doctors printed materials that 8 would have the checklist for the eight 9 different items that a physician should look 10 at in making a diagnosis of depression? 11 A. We have provided screening tools as part 12 of a number of materials to physicians to help 13 them screen or further investigate whether or 14 not a patient they believe has depression 15 does. 16 Q. Is one of those screening tools a card 17 or pad or other material that lists the eight 18 diagnostic criteria for depression under the 19 DSM-4? 20 A. I seem to recall that there was a 21 document like that, that there was a -- 22 Q. Okay, here is another acronym for you. 23 Do you know what DDMAC is? 24 A. Yes. 25 Q. What is that? 0050 1 A. The advertising division of the FDA. 2 Q. Are those sort of the advertising police 3 within the FDA? 4 A. They are the people that review the 5 advertising. 6 Q. Now, if they have a problem with 7 advertising or other promotional materials for 8 Paxil, are you the person or is your 9 department the department that would receive 10 information about that? 11 A. No, the regulatory department. 12 Q. And is Doctor Donnelly still the 13 director of regulatory affairs? 14 A. No. 15 Q. Who is? 16 A. For CNS? 17 Q. Yes, ma'am. 18 A. Who would have been Tom Donnelly's 19 replacement? 20 Q. Right. 21 A. A fellow by the name of Tom Klein. 22 Q. Klein? 23 A. Yes. 24 Q. Is he also a vice-presidential level 25 person? 0051 1 A. He is not. 2 Q. So is he subordinate to you within the 3 organization? 4 A. He is not in the same organization as I 5 am. He is in regulatory, and I am in the 6 marketing organization. 7 Q. I see. Well, I have here a couple of 8 documents I want to ask you if you have ever 9 seen before, and perhaps, you haven't, given 10 the testimony you just gave. Let's mark that 11 one whatever we are up to. 12 - - - 13 (Whereupon the court 14 reporter marked document as Exhibit 23 for 15 identification.) 16 - - - 17 BY MR. VICKERY: 18 Q. Exhibit 23 is a document that was 19 produced for us in this litigation. It is a 20 letter dated January 6, 1993 to Doctor 21 Donnelly from the FDA about certain problems 22 with launch materials. 23 Have you ever seen the 24 letter? 25 A. May I take a look at it? 0052 1 Q. Oh, sure. Take whatever time you like. 2 A. I vaguely recall this letter, yes. It 3 would have arrived roughly about the same time 4 I was joining the team. 5 Q. And do you recall having to jump through 6 some hoops to rectify the problems that the 7 FDA found with the promotional material that 8 you all were going to use for the launch? 9 A. I recall that there were some 10 modifications made. I don't remember the 11 specific changes. 12 Q. Now, is this out of the ordinary or this 13 sort of business as usual to get this kind of 14 letter from the FDA sort of chiding you for 15 promotional materials? 16 MR. PREUSS: I will object 17 to the form of the question. 18 BY MR. VICKERY: 19 Q. Let me rephrase it, because that's 20 probably a good objection. 21 When I say chiding, I guess 22 I'm characterizing it, and I'm sure this 23 letter speaks for itself. 24 Is it customary or out of 25 the ordinary for your company to receive such 0053 1 a letter with regard to promotional materials 2 for a drug? 3 A. We don't receive a lot of letters like 4 this. This looks like it was a letter that 5 was sent before we introduced the drug. 6 Q. Yes, it certainly does. About a month 7 before, I gather? 8 A. Yes. 9 Q. And to the best of your knowledge, were 10 the FDA's concerns all addressed, and were the 11 materials modified as necessary to make all 12 these changes? 13 A. To the best of my knowledge, the changes 14 were made. I would have to go back and 15 compare this letter with the original 16 materials and look at the follow-up to give 17 you a thorough answer on that. 18 Q. Right, but as you sit here today, you 19 think that probably most, if not all, of these 20 concerns were addressed, and the materials 21 were modified in whatever way was necessary to 22 satisfy the FDA? 23 A. I'm assuming. I honestly don't -- I 24 would really need to look at this letter and 25 compare it with the materials that we 0054 1 submitted and then the revised materials. 2 Q. A little over a year and a half later, 3 you all got another letter, and let me hand it 4 to you, from DDMAC again. 5 - - - 6 (Whereupon the court 7 reporter marked document as Exhibit 24 for 8 identification.) 9 - - - 10 BY MR. VICKERY: 11 Q. 24 is a letter with control numbers -- 12 it has got two sets of control numbers, 13 SB0000064 is the first page, and it seems to 14 be a letter from the FDA, dated August 31, 15 1994 to Doctor Brennan. 16 What division was Doctor 17 Brennan in? 18 A. Regulatory. 19 Q. Did he take over from Doctor Donnelly? 20 A. He did. 21 Q. All right. And have you seen this 22 letter before? 23 A. Yes, I recall seeing this. 24 Q. Did SmithKline Beecham make all of the 25 changes that the FDA wanted changed here, 0055 1 according to this letter? 2 A. We made some changes. Again, I would 3 have to really thoroughly read this letter, it 4 has been six years, and look at it next to the 5 changed materials to say which changes were 6 made to give you an accurate answer. 7 Q. Is it alarming to the company, when you 8 get a letter from the FDA that says, in a 9 number of different respects, that you are 10 using false and misleading advertising to 11 promote Paxil? 12 A. The letter came to regulatory. I'm not 13 sure what their reaction was. And I don't 14 recall the details of how -- what it was that 15 the FDA or DDMAC was characterizing as false 16 and misleading. 17 Q. Well, the materials, even though the 18 letter is addressed to the folks in the 19 regulatory department, the materials that were 20 categorized as false and misleading are 21 materials that are used by your people in 22 marketing, aren't they? 23 A. Yes. 24 Q. And so as the vice-president for 25 marketing, is it alarming to you when the FDA 0056 1 sends a letter to your company that says, hey, 2 you know, these materials are being used by 3 people under your supervision are false and 4 misleading? 5 A. It is a matter for attention. 6 Q. There is actually sort of a hierarchy, 7 if you will, of letters, isn't there? In 8 other words, there is different levels, 9 depending on the severity of the matter and 10 how long it has gone on as to who they write 11 and when? 12 A. Probably. I'm not sure. 13 Q. To your knowledge, has the chairman or 14 chief executive officer of your company ever 15 gotten a letter from the FDA about false or 16 misleading advertising for Paxil? 17 A. I don't believe so. 18 Q. Now, is there some level at which there 19 is informal contact between the FDA and your 20 company, if you know? 21 A. There probably is. 22 Q. I mean specifically about concerns that 23 they may have over false or misleading 24 advertising? 25 A. I don't know. I don't know. Doctor 0057 1 Wheadon would be the person to ask about 2 that. 3 Q. I know that you have experience in 4 forecasting and sort of crystal-balling. 5 What would be the effect on 6 sales of Paxil if your company had to put a 7 bold-face warning on the label about Paxil 8 causing suicide or violence in some patients? 9 MR. PREUSS: I object to 10 the form. 11 BY MR. VICKERY: 12 Q. You can answer my question. 13 A. That's very hypothetical. That would 14 depend on a lot of different factors. We have 15 not done those forecasts, but it would depend 16 on a number of different factors. 17 Q. You know for certain that it would hurt 18 sales, don't you? 19 A. Well, it would depend on, for example, 20 whether it was a class labeling change. 21 Q. Right. If all the other SSRI drugs had 22 to do the same label, it wouldn't hurt you as 23 bad? Is that what you are saying? 24 A. Probably not. 25 Q. But just as a general matter, you would 0058 1 concede that it would have to hurt sales if 2 there were a warning about suicide on your 3 label, wouldn't you? 4 A. It probably wouldn't help. 5 Q. And especially, with that 55 percent of 6 the market that are non-mental health 7 professionals, don't you think that it would 8 discourage them from prescribing Paxil at all? 9 MR. PREUSS: I object to 10 the form. 11 THE WITNESS: I honestly 12 don't know. I think that would be very 13 individual. I think it would depend on the 14 individual physician's experience with the 15 drug, you know, his level of confidence in the 16 drug, how long the drug was on the market. 17 MR. VICKERY: I think 18 that's all I have. 19 MR. FARBER: It will take 20 me a minute here to transfer all my papers. 21 THE VIDEO TAPE OPERATOR: 22 Going off the video record. The time is 23 2:06. 24 THE VIDEO TAPE OPERATOR: 25 Back on the video record. The time is 2:10. 0059 1 - - - 2 EXAMINATION 3 - - - 4 BY MR. FARBER: 5 Q. Ms. Rossello, I'm Donald J. Farber. I'm 6 in a lawsuit different than Mr. Vickery's. I 7 don't know whether you knew that, but we have 8 a different lawsuit in California for my 9 client. 10 And I just wanted to ask 11 you, have you been advertised or are you aware 12 of the general nature of our wrongful death 13 lawsuit, Lacuzong versus SmithKline, the 14 general details? 15 A. I don't know the details of the case. 16 Q. Do you know any generalities before 17 today about the nature of the lawsuit? 18 A. I know that you represent clients who 19 claim to have sustained injuries. 20 Q. Are you aware that it is a wrongful 21 death lawsuit? 22 A. I don't know that I heard it described 23 as a wrongful death. 24 Q. Are you aware that there has been a 25 fraud allegation in the lawsuit? 0060 1 A. No. 2 Q. Picking up on Mr. Vickery's questioning, 3 I just made some notes, so I will pick off on 4 your CV and some other notes here. 5 And on your bio sheet, I 6 have noticed that you are an English and 7 literature major from West Chester in 1976, 8 right? You look much younger than that. 9 A. Thank you. 10 Q. You do. 11 And I have a question about 12 -- I have your sheet and the product 13 information sheet, but I would like a little 14 more detail, if you will, on the functions, 15 the staff functions that occur within your 16 organization, both external and to the 17 internal headquarters. 18 Could you reel off eight or 19 ten or however many there are functions that 20 your organization performs? 21 A. The people that report to me? 22 Q. Yes. 23 A. They are responsible for the marketing 24 activities for those products that I 25 described. So that would include development 0061 1 of sales promotion, exhibits for conventions, 2 working in conjunction with medical and 3 regulatory on symposia. 4 Q. On information? 5 A. Yes. 6 Q. I had that question, now, in the area 7 of, let's say, my term lobbying, a lobbyist in 8 Washington or whatever would not be in your 9 organization; correct? 10 A. Correct. 11 Q. And you have answered, on media 12 relations, that is unrelated technically to 13 your organization? 14 A. Correct. 15 Q. Although you have had a media 16 background? 17 A. Yes. 18 Q. Do you coordinate to any degree with 19 your lobbying organization? 20 A. No. Rarely. I mean, I can't think of 21 an example in the past history where -- 22 Q. You don't ordinarily do business with 23 them once a month or anything? 24 A. No. 25 Q. How about the media division? 0062 1 A. When you say media, now, do you mean the 2 people who are buying advertising space? 3 Q. No, I'm talking about media inquiries. 4 A. Corporate communications. 5 Q. Yes. Do you deal with them frequently 6 in your job? 7 A. Not frequently. 8 Q. Occasionally? 9 A. Occasionally. 10 Q. Like once a week or once a month? 11 A. When the occasion warrants it. 12 Q. Just going from top to bottom here, I 13 notice your topic -- this is the page I'm 14 looking at on the exhibit, topic, and then the 15 contents, kind of a little Q&A or a standard 16 response to that effect. 17 If you would notice on the 18 fourth one down -- 19 A. I'm sorry. Which exhibit is this? 20 Q. I'm sorry, I don't know the exhibit 21 number, but it was -- 22 MR. PREUSS: It is 22. 23 THE WITNESS: Oh, I will 24 find it. 25 MR. FARBER: Take your 0063 1 time. 2 THE WITNESS: Yes, I have 3 it. 4 BY MR. FARBER: 5 Q. Now, we have a list of 17 topics and the 6 contents under each. What organization 7 establishes a list of topics, the need, let's 8 say, for an additional topic, if we had an 9 18th topic, what organization at SmithKline 10 would tell you to do that or tell you to add 11 that to the list? 12 A. Product information. 13 Q. And that's not your organization? 14 A. No. 15 Q. And how about fulfilling the contents 16 for that topic? Is that the same 17 organization? 18 A. Product information prepares those 19 letters. 20 Q. Now, under the fourth one down, it says, 21 discontinuation symptoms reported with the use 22 of Paxil; correct? 23 A. Um-hum, yes. 24 Q. What year was that particular topic 25 formulated? 0064 1 A. I don't remember. 2 Q. Any ballpark guess? Do you have any 3 idea? 4 A. I would really be guessing. I don't 5 know. 6 Q. I don't want you to guess. If you have 7 some element of certainty above a guess, I 8 want it, but -- 9 A. I don't. 10 Q. As far as you know, was this particular 11 topic there from the inception of your 12 knowledge of this document? 13 A. I don't know. I don't think it was. 14 Q. So it came on or it was added some time 15 during your tenure then is what you believe? 16 A. Probably. 17 Q. Do you have a specific recollection on 18 this topic being added? 19 A. I do not. 20 Q. Do you have a general recollection of it 21 being added? 22 A. I would have to go back and look at the 23 date, if I wanted to be completely accurate. 24 Q. Okay, just the mere fact that you recall 25 it, but that's all you do at this time? 0065 1 A. Yes. 2 Q. Now, how about for the contents of 3 discontinuation, over to the right, it says, 4 quote, extensive discussion and review of 5 literature, studies and spontaneous reports 6 suggestions for management. 7 Where did this contents 8 input come from in the company? 9 A. That would have been -- it would have 10 come from product information, medical and 11 regulatory. 12 Q. Now, you are not, and neither am I -- 13 I'm not a technical person, so I have to do a 14 lot of studying, so I'm just asking you this. 15 When you get something 16 technical in your organization, do you place 17 this down in the paper without any questions 18 or if you have a reservation about something 19 technical that came from the experts, do you 20 ever challenge him on it or have you, in fact 21 -- you just print down what they suggest? 22 A. I might ask a question for my own 23 edification. 24 Q. For clarity sake, okay. 25 Now, do you happen to know 0066 1 where the term review of literature, what that 2 means? Extensive discussion and review of 3 literature, what type of literature do you 4 think you are talking -- or what type of 5 literature are you talking about? 6 A. I'm assuming it means the information 7 that was obtained from published studies, et 8 cetera. 9 Q. Okay. 10 A. Publications. 11 Q. You don't know what those publications 12 were? 13 A. I don't. 14 Q. When this input was given to you, no 15 list of particular publications was provided 16 to you, I assume? 17 A. Correct. 18 Q. As we sit here today, are you aware of 19 literature that states that Paxil does cause 20 discontinuation symptoms? 21 A. I am aware that there have been reports 22 associating Paxil with discontinuation 23 symptoms. 24 Q. Media reports or academic articles or 25 what? 0067 1 A. Academic articles. 2 Q. And is it your knowledge that there are 3 just a few scatterings of these articles or 4 they are fairly plentiful? 5 A. I couldn't tell you what the volume of 6 those reports was. 7 Q. Has the subject of discontinuation 8 symptoms been discussed within the company? 9 A. Yes. 10 Q. And have you made -- have you been 11 present during those discussions? 12 A. I have on occasion. 13 Q. And what are the names of the other SK, 14 SmithKline officials, all of them, that were 15 present during any of these discussions? 16 A. David Wheadon. 17 Q. Okay. Others? 18 A. It would have been one of the physicians 19 on the team. 20 Q. One of the physicians on the team? 21 A. One of the medical, yes, physicians, one 22 of the psychiatrists. 23 Q. Who was that? 24 A. I believe it was Rash Kumar. 25 Q. Rash Kuman? 0068 1 A. Kumar. 2 Q. Kumar, I know Kumar, Indian name, 3 K-U-M-A-R? 4 A. That's right. 5 Q. Anybody else? 6 A. No, I think it was just -- maybe 7 somebody from regulatory. I can't remember. 8 This is going back. 9 Q. So how many such meetings to discuss 10 this subject have you attended? 11 A. One, maybe two. 12 Q. One or two. And when were those held? 13 A. Quite a while ago. I don't remember 14 specifically. 15 Q. I mean in the last three years or '94 or 16 -- 17 A. Some time in the last three years, I 18 guess. 19 Q. Other than a meeting, when is the last 20 time you were engaged in discussions on this 21 issue, the discontinuation issue? The last 22 time that anybody from SKB talked to you about 23 the discontinuation symptoms reported with the 24 use of Paxil, either pro or con? 25 A. I probably heard a review of 0069 1 discontinuations at a symposia that was 2 sponsored by SKB. 3 Q. By whom? 4 A. By SmithKline Beecham. 5 Q. And where was that symposium? 6 A. This is three years ago. I'm sorry. I 7 am really reaching back to try to recall. 8 Q. You can take your time on any one of 9 these responses to gather your thoughts, 10 because it is hard to recall specifically a 11 detail from many years ago. I know that. So 12 if you want some time to think about it, just 13 let me know, and no problem. 14 Have you ever heard -- Mr. 15 Vickery asked you about half-life of Paxil. 16 Have you ever heard any 17 discussions among anyone about the connection 18 between half-life and discontinuation symptoms 19 of Paxil? 20 A. Yes. 21 Q. And who did you hear that from? 22 A. I recall reading that. I don't remember 23 where I read that. 24 Q. Did you read it once or -- 25 A. Yes. 0070 1 Q. At least once? 2 A. Yes. 3 Q. And do you recall what the substance of 4 that conclusion was about that article? 5 A. That half-life theoretically may play -- 6 may be one of the factors involved in 7 discontinuation. 8 Q. And the shorter the half-life, the 9 greater the tendency to addict or the 10 opposite? Do you recall in substance what 11 that -- 12 MR. PREUSS: Mr. Farber, I 13 object to the form of the question. You have 14 been asking questions about discontinuation 15 again. This deposition is on Lacuzong. 16 Lacuzong has nothing to do with 17 discontinuation. Discontinuation is not a 18 part of the 30(b)(6) notice of Mr. Vickery. 19 I have allowed you to ask a 20 few questions again, but we went through this 21 once with Doctor Wheadon, and I would like you 22 to use your time productively to cover that 23 other area. 24 MR. FARBER: And of course, 25 I could repeat, too, and I won't, the nature 0071 1 of the suit, and the fact that this particular 2 symptom or lack thereof was presented to the 3 committee in October of '92 specifically to 4 get and part of the approval process. I will 5 repeat that again. 6 So I think we are both on 7 the record for our positions on both of these 8 occasions. And I'm just about done with the 9 subject. 10 MR. PREUSS: I hope so. 11 MR. FARBER: But I want to 12 finish this one question. 13 BY MR. FARBER: 14 Q. Is it your understanding that Paxil's 15 half-life has a greater or less tendency to 16 addict than Prozac? 17 MR. PREUSS: I object to 18 the form of the question. No foundation. 19 THE WITNESS: I'm sorry? 20 BY MR. FARBER: 21 Q. Okay, whatever you learned about the 22 half-life of Paxil and whatever you learned 23 about its tendency to addict -- 24 A. I don't know anything about Paxil's 25 tendency to addict. To the best of my 0072 1 knowledge, Paxil doesn't addict. 2 Q. I'm sorry. I should have used the word 3 which I have been using, its discontinuation 4 symptoms. The half-life and its tendency to 5 induce discontinuation symptoms? 6 A. These are questions, Mr. Farber, for 7 Doctor Wheadon. I am not an expert on 8 discontinuation. My general understanding is 9 that all of the SSRI's have some potential to 10 cause discontinuation symptoms. 11 Q. Yes, but I'm only ask you in the context 12 with the contents that you printed under your 13 -- that's the only -- 14 MR. PREUSS: There is no 15 question. 16 BY MR. FARBER: 17 Q. So is it fair to say that you basically 18 don't know anything more about half-life or 19 anything else on discontinuation than what you 20 have testified to here today? 21 A. Yes. 22 Q. Now, in your duties, was I correct in 23 picking up that you had assumed your 24 vice-presidential duties early this year? 25 A. In 1999. 0073 1 Q. In 1999. 2 And your actual assumption 3 of the position was before that; correct? 4 A. Yes. 5 Q. And when was that? 6 A. In '98. 7 Q. And in '98, who did you replace, the 8 individual at SmithKline? 9 A. David Brand. 10 Q. Oh, David Brand, B-R-A-N-D? 11 A. Yes. 12 Q. Where is -- is David Brand still 13 employed with the company? 14 A. Yes. 15 Q. What is his position now? 16 A. He is the vice-president of the 17 endocrine cardiovascular business unit. 18 Q. I'm sorry, the vice-president of the 19 cardiovascular? 20 A. Endocrine business unit. 21 Q. Business unit? 22 A. Yes. 23 Q. Oh, okay. 24 So when you assumed the 25 position, did you, I'm sure, looked over the 0074 1 files and what was going on in kind of 2 assuming your new duties to determine what 3 publications and policies and paperwork had 4 been promulgated by your unit in the preceding 5 few years, did you not? 6 A. We had a transition meeting, yes. 7 Q. Did Mr. Brand ever use the term, to your 8 knowledge, to the sales consultants to stay in 9 the fast lane? 10 A. Stay in the fast lane? I never heard 11 him say that, but he may have. 12 Q. Does the term fast lane at all ring a 13 bell as to any phrase he may have coined? 14 A. No. 15 Q. Did you ever read letters that he 16 distributed to the sales force? 17 A. Mr. Brand? 18 Q. Yes. That will be the question. Did 19 you examine the -- 20 A. I don't actually recall any 21 communications from David Brand to the sales 22 force, which is not to say that there weren't 23 any, but I don't recall any specific memos 24 that he would have sent. 25 Q. Is that a function -- let's assume that 0075 1 the boss of the organization wants to send out 2 general guidance or specific guidance to 3 everybody in the North American Division, 4 which is, what, 16 areas? Kind of a general 5 topic for everybody. Is that a method that 6 SKB employs to get the word out? 7 A. Yes, it wouldn't be unusual for the head 8 of marketing or sales to send out a 9 communication. 10 Q. And Brand, Mr. Brand did that. Have you 11 promulgated similar letters in your position? 12 MR. PREUSS: Objection, 13 assuming facts not in evidence. I object to 14 the form. 15 BY MR. FARBER: 16 Q. Have you promulgated letters to sales 17 consultants in any of the 16 regions from your 18 office and under your signature? 19 A. Yes. 20 Q. And how often over the past year, let's 21 say the past 12 months, give me a -- 22 A. Over the past 12 months? Maybe half a 23 dozen. 24 Q. Okay, maybe every couple of months on 25 the average, okay. 0076 1 Now, earlier, you mentioned 2 that the sales consultants -- is that the 3 proper term? 4 A. Yes. 5 Q. That they received both salary or wage 6 or income and commission. 7 What is the proportion of 8 one to the other, approximately? 9 A. I'm honestly not sure. I'm not 10 responsible for that. 11 Q. You had earlier mentioned -- is it 12 Doctor Nemeroff in Atlanta? 13 A. Yes. 14 Q. And you had mentioned -- I won't ask you 15 any personal questions. I noticed you 16 mentioned a funeral or something, so you 17 apparently have had a professional 18 relationship with him for a long time; 19 correct? 20 A. Yes. 21 Q. Now, you said that he was the principal 22 investigator on this one particular study? 23 A. Yes. 24 Q. Do you know if the principal 25 investigators receive any pay from SmithKline 0077 1 Beecham for their participation in those 2 studies? 3 A. I don't know what the arrangement would 4 be. That would be a medical question. I'm 5 assuming we reimburse them for -- I actually 6 don't know. I shouldn't speculate. I don't 7 know. 8 Q. No, don't speculate or guess. So you 9 know nothing -- essentially nothing about 10 that? 11 A. Correct. 12 Q. Back to the DDMAC letters from FDA, Mr. 13 Vickery covered some of that. I know this is 14 what I would consider a formal letter. And 15 Mr. Vickery alluded to the subject of lesser 16 forums or lesser formalities in communicating 17 false or misleading type information or 18 allegations or so forth. 19 Do you know of informal -- 20 the existence of a system of informal letters 21 from FDA to violators that don't take on the 22 formality of DDMAC formal numbers? In other 23 words, more of an informal system of sending 24 out allegations of discrepancies and false and 25 misleading areas? 0078 1 A. There is a process by which the company 2 communicates with DDMAC that may be more 3 informal that includes conversations. 4 Q. It could be telephone conversations? 5 A. Yes. 6 Q. It could be notes or any number of 7 mechanisms? 8 A. Yes. 9 Q. Do you know of any concerns -- and I 10 will stick -- keep to Paxil right now -- 11 concerns by FDA personnel of false and 12 misleading areas that were not conveyed in 13 these formal DDMAC letters? Do you know of 14 any? 15 A. No. 16 Q. Now, the last exhibit we had that I 17 think you said was 24, and I only have one 18 copy, so we are going to have to go through 19 the xerox of this, it is my only copy, but I 20 will have to give it up here temporarily. 21 The last one we had was 22 dated August 31st by FDA. We have another one 23 here I would like to put into exhibit as 24 Exhibit 25, dated just six days later, which 25 was September 6, 1994. And I'm going to ask 0079 1 you essentially the same question about this 2 letter that Mr. Vickery asked you. 3 And in addition to the 4 alleged discrepancies, there are notes written 5 by the alleged violator on why there were 6 violations and so forth. So I will put that 7 in as Exhibit 25 and ask you to look at that 8 one as well. 9 - - - 10 (Whereupon the court 11 reporter marked document as Exhibit 25 for 12 identification.) 13 - - - 14 MR. PREUSS: May I see it 15 first, please? 16 THE VIDEO TAPE OPERATOR: 17 Going off the video record. The time is 18 2:34. 19 THE VIDEO TAPE OPERATOR: 20 Back on the video record. The time is 2:35. 21 BY MR. FARBER: 22 Q. Back on the record. And Ms. Rossello, 23 have you had a chance to look at the new 24 exhibit? 25 A. No. 0080 1 Q. Okay, please take your time. 2 MR. PREUSS: Don, I noticed 3 that you turned the page, in other words, it 4 looks like a fax transmission, and which would 5 probably be the first page, at least that's 6 how it is numbered, 86 is the first number, so 7 I assume you want to put in the fax page? 8 MR. FARBER: You can put in 9 the whole thing. 10 BY MR. FARBER: 11 Q. And my question on the exhibit is, is 12 this a document you have seen before? 13 A. I recall this document. 14 Q. And similar question to Mr. Vickery's, 15 do you believe at this point that corrective 16 action was taken on those discrepancies listed 17 in that letter? 18 A. I believe that it was. 19 Q. And are you familiar with the employee 20 who allegedly wrote that note? 21 A. I do not know who the employee is. 22 Q. You don't have any personal knowledge of 23 the individual? 24 A. I do not. 25 Q. Do you have any knowledge that all three 0081 1 of these exhibits, the one from August that 2 Mr. Vickery introduced, and that one, the 3 three together, do you have any knowledge that 4 those allegations were invalid? 5 I know you testified that 6 you hadn't checked everything out, you don't 7 know one way or the other, but my question is 8 a little different. 9 Do you have any indication 10 or knowledge now that any of those allegations 11 in any of those three letters were invalid? 12 A. This one was directed at the specific 13 actions of an individual representative who 14 acted on their own and should not have. 15 So to that extent, they 16 were violating the regulations by which 17 SmithKline practices. These letters that we 18 reviewed, I really would have to go back and 19 look at the original pieces to compare and see 20 which changes we viewed as valid. 21 Q. Okay. I won't follow up on that. I 22 understand what you are saying. I would 23 disagree with you that the fact that was by a 24 lowly sales rep at the bottom, and those may 25 have been written by people way up on top, in 0082 1 a more general way, I wouldn't draw any 2 distinction between those two, but that's just 3 my commentary on that, and that's the tint of 4 my question. 5 I have a new exhibit on a 6 new issue now, and again, it is my only copy, 7 and we are at Number 26. 8 - - - 9 (Whereupon the court 10 reporter marked document as Exhibit 26 for 11 identification.) 12 - - - 13 BY MR. FARBER: 14 Q. You can show it to your counsel, and 15 then I will have a question on it. 16 Now, you may not know 17 anything directly about that incident, because 18 it occurred before your direct watch, but it 19 is allegedly an incident in 1991, in which 20 physicians were paid or compensated for 21 attendance at a Paxil gathering sponsored by 22 SmithKline to discuss the drug in some manner 23 at a time before Paxil was approved as a 24 marketable drug. 25 And my question doesn't 0083 1 concern that subject so much as you mentioned 2 earlier about budgetary allowances for 3 promotional activities. And my question is 4 about budgetary allowances for physicians and 5 other health care professionals to attend 6 gatherings sponsored by SmithKline Beecham. 7 So take from 1991 to the 8 year 2000. Are there budgets allowed that 9 sponsor physicians and other health care 10 providers, pharmacists or whatever, to attend 11 functions sponsored or encouraged by 12 SmithKline Beecham? 13 MR. PREUSS: I object to 14 the form. 15 THE WITNESS: We provide 16 honorarium to our advisory board and to 17 people, physicians, who speak on behalf of 18 SmithKline for -- to groups of other 19 psychiatrists or primary care and to 20 consultants, people who provide us with 21 information about the field, medical needs in 22 the field, et cetera. 23 BY MR. FARBER: 24 Q. Okay, that's logical. 25 Do you provide funding for 0084 1 sponsorship of people who are opposed to Paxil 2 who attend these same gatherings? 3 A. I'm sorry? 4 Q. You just gave me an answer to indicate 5 that physicians, who are basically involved in 6 prescribing Paxil or supporting Paxil attend 7 these events under your sponsorship or at 8 least paid for; correct? 9 A. People who are going to speak on behalf, 10 people who need knowledge of Paxil. 11 Q. People who need knowledge? 12 A. Right, because they are going to be 13 speaking on behalf of the drug. 14 Q. So they are supportive of Paxil? That's 15 the premise of your response? 16 A. I could not necessarily say that every 17 physician to whom we provide speaker 18 information and materials is completely 19 supportive of Paxil. We are providing them 20 with information, and we are getting from them 21 feedback, et cetera. 22 Q. And these individuals who attend, I'm 23 assuming you don't personally clear this 24 doctor, I'm assuming you get that information 25 from another source in the headquarters. 0085 1 A. I'm sort of getting lost in my own 2 answer here. I have forgotten what the 3 question was. 4 Q. Paying people to go to meetings to speak 5 on behalf of Paxil. That's my line of 6 inquiry. And you have indicated there is some 7 budgetary allowances for people to attend 8 these meetings that will speak on behalf of 9 Paxil that promote the drug or think the drug 10 is good; correct? 11 A. People to whom we are providing 12 information and who are giving us information 13 in return. So these are paid consultants. It 14 is a small group of physicians. 15 Q. Okay, they are paid consultants by 16 SmithKline. So it is fair to assume they are 17 basically pro Paxil, pro SSRI or pro 18 antidepressant drug physicians; correct? 19 MR. PREUSS: I object to 20 the form. 21 THE WITNESS: I don't make 22 any assumptions about the physicians. These 23 are people we have identified as people who 24 have expertise in the field of psychiatry, 25 usually, who have published in the field, who 0086 1 we are asking for input on. 2 BY MR. FARBER: 3 Q. Okay, I understand. 4 You do know, do you not, 5 that there maybe not a majority, but there is 6 a community of critics of SSRI's in the 7 medical field; correct? 8 A. I don't have a lot of awareness about 9 the body of people who are critics. 10 Q. Well, other than lawyers, don't you know 11 or do you know -- I don't want to force you 12 into an answer you don't want. 13 Do you know that there are 14 psychiatrists and physicians who are opposed 15 to SSRI's because they think they cause 16 suicide ideation? You are aware of that, 17 aren't you? 18 A. I am aware. 19 Q. So I will call them critics. I will 20 call them critics of the pharmaceutical 21 industry. You don't fund these critics to go 22 talk at these symposiums, do you? 23 A. I don't fund people who aren't providing 24 me with input. SmithKline funds people who we 25 consult, who act as consultants to us. 0087 1 Q. And do you know of any active 2 consultants who are anti-Paxil? 3 A. I'm sorry. I don't understand the 4 question. 5 Q. Do you have any paid consultants in this 6 category who are against SSRI's as a general 7 proposition? 8 A. The people that we consult have varying 9 opinions about SSRI's and all treatment 10 options for the treatment of depression and 11 anxiety disorders. 12 Q. I understand that no two experts are the 13 same. We are all individuals. But I want to 14 get a little more to the right or left, 15 depending on your position, as to whether you 16 have, as paid consultants, psychiatrists or 17 physicians who are anti-SSRI as a general 18 proposition. In other words, critics. I 19 think I used the word critics. Do you have 20 critics who are paid consultants? 21 A. I have no -- to the best of my 22 knowledge, no. We have people who criticize 23 -- 24 Q. I'm not suggesting you would. Some 25 people might say it is stupid to hire somebody 0088 1 who is your enemy, so I'm not saying it is 2 ill-advised. I just wanted to get the facts 3 on the record that from what my understanding 4 is, your paid consultants are only those -- 5 A. Our paid consultants, I think, have a 6 very -- offer a very balanced picture of the 7 literature and -- 8 Q. I would disagree with that, but I will 9 let that go. 10 MR. PREUSS: Did you finish 11 your answer? 12 THE WITNESS: Yes. 13 BY MR. FARBER: 14 Q. But you would concede, would you not, 15 that the balance does not include critics of 16 SSRI's? 17 A. Yes. 18 Q. Your sales consultants, what is their 19 discipline in terms of background education? 20 A consultant in -- I will take my area, Los 21 Angeles, hired sales consultants in your Los 22 Angeles office have what general -- what's 23 their degree in? 24 A. I couldn't tell you. They have 25 undergraduate degrees. I don't know in what. 0089 1 Q. They are not necessarily biology majors 2 or -- 3 A. Not necessarily. 4 Q. They are probably just good salesmen, 5 like most organizations. 6 Do you actively market the 7 drug in Asian -- Paxil in Asian countries? 8 A. I believe Paxil was just approved for 9 the use in Japan. 10 Q. Do you have a regional sales consultant 11 now assigned to Japan? 12 A. That would be outside of my province. I 13 have nothing to do with anything outside of 14 the US. 15 Q. But within your responsibility, have you 16 now added Japan to your list of people that 17 get your messages? 18 A. No. 19 Q. In terms of the hierarchy, the Japan 20 sales, now that is approved, would come under 21 what regional office of yours? 22 A. That would report into the international 23 division. 24 Q. Not in North America? 25 A. Right. 0090 1 Q. Okay, I got you. 2 Do you have any particular 3 promotional philosophies about marketing the 4 drug in California, where there is a large 5 amount of Mexican and Asian populations? 6 MR. PREUSS: I object to 7 the form, unintelligible. 8 MR. FARBER: Okay, it is 9 compound. 10 BY MR. FARBER: 11 Q. Do you have any particular -- have you 12 had promotional efforts directed at the 13 Spanish-speaking population of California? 14 A. We have made our information available 15 in Spanish. 16 Q. How about in Asian languages, other than 17 Japan? 18 A. We may. I'm not aware. There may be 19 translations in Chinese. I'm not sure of 20 that. 21 Q. Language aside, in terms of the 22 subpopulation for clinical trials, for 23 example, in the Asian races, have you 24 attempted or is it part of your -- 25 correction. 0091 1 Is it part of your current 2 sales campaign to advertise that Paxil has 3 never been tested specifically on Asian 4 subgroups? 5 A. I'm sorry? I didn't understand the 6 question. 7 Q. Do you have knowledge that Paxil has or 8 has not been specifically tested on Asian 9 subgroups of the population? 10 A. I don't know that. 11 Q. Do you have any knowledge whatsoever on 12 the subject of the appropriateness of Paxil as 13 an SSRI for Asian races? 14 A. No, I have no knowledge. 15 Q. Have you ever heard that subject 16 discussed at any time at SmithKline Beecham? 17 A. No. 18 Q. How many meetings have you attended -- 19 start with meetings. How many meetings have 20 you attended where the subject of SSRI's -- I 21 will keep it as SSRI's -- SSRI's and suicide 22 or suicide ideation has been discussed? 23 A. None. 24 Q. None? Okay. 25 What does the term 0092 1 preferred drug mean to you, if anything? 2 A. It sounds like a managed care term. 3 Q. Do you know whether -- has there been an 4 effort by SmithKline Beecham to make Paxil a 5 preferred antidepressant drug among managed 6 care organizations? 7 A. There has been an effort to make Paxil 8 available on managed care formularies. 9 Q. I understand that. My specific 10 reference is to a preferred drug, quote, 11 unquote. 12 A. That's a question for the managed care 13 division. 14 Q. There is a separate managed care 15 division? 16 A. There is. 17 Q. All right. If I were to ask you, which 18 I will, if I were to ask you if Paxil were a 19 preferred SSRI drug for the San Jose Medical 20 Group in San Jose, California and to ask you 21 what individuals at SKB were responsible for 22 making that successful deal, who would that 23 be? 24 MR. PREUSS: I object to 25 the form, assuming facts not in evidence. 0093 1 BY MR. FARBER: 2 Q. Do you understand what I was saying? 3 A. Could you restate -- 4 Q. Yes. 5 Do you have any knowledge 6 that Paxil is or was a preferred SSRI at 7 certain -- any health care organizations, 8 managed care organizations in California? 9 A. I don't have specific knowledge about 10 the status of Paxil, the formulary status of 11 Paxil. 12 Q. And if I asked you who was responsible 13 for Paxil becoming a preferred SSRI at the San 14 Jose Medical Group and tell you at the same 15 time that that is a fact and asking you for 16 the official or sales organization who made 17 that happen, what would that be or who would 18 that be? 19 A. I would say that was a result of a 20 decision made on the part of San Jose Medical 21 Clinic. 22 Q. It was a decision, but as far as the 23 representation of the drug to that group to 24 sell it, it was obviously -- 25 A. The information that was communicated to 0094 1 them that resulted in that could have come 2 from any number of sources, but probably the 3 managed care division, a representative from 4 the managed care division. 5 Q. Okay, and I want to get kind of a chain 6 of command question. 7 You have a Los Angeles 8 office, do you not? 9 A. Sales office, yes. 10 Q. And you have a comparable office of a 11 functional responsibility here in Philadelphia 12 to oversee that? 13 A. There is a central sales office here in 14 Philadelphia, and then there are, today, I 15 think 21 regions across the country. I can't 16 tell you exactly what cities those offices are 17 in. 18 Q. But is it logical or -- not is it 19 logical. If San Jose Medical Group had Paxil 20 as a preferred SSRI, would that sales venture 21 have been executed by your people in Los 22 Angeles or your people -- 23 A. Probably a local representative, not 24 sales, but managed care. 25 Q. Managed care in Los Angeles or 0095 1 Philadelphia? 2 A. Probably in Los Angeles. I don't know. 3 I don't have the specifics. I am really 4 guessing here. 5 Q. I'm just setting up the scenario, if 6 that happened, and who would likely have been 7 responsible for that happening at SmithKline, 8 so you have answered my question. 9 Now, in terms of your Los 10 Angeles office, who are one or two individuals 11 that operate out of your Los Angeles office to 12 do these sorts of things? 13 A. I don't have those names. I don't 14 know. 15 Q. Do you know any name in Los Angeles? 16 A. No, I don't know managed care 17 representatives in Los Angeles. 18 Q. My next question is on records, whether 19 you were visiting physicians or clinics or in 20 any one of your sales efforts, do your company 21 records require a written record of all the 22 visits that your Paxil sales consultants had 23 made to each one of these places? 24 A. Yes, I believe they do. Again, sales 25 does not report into my position. 0096 1 Q. Now, I want to ask you about people in 2 your organization. Let's just take your 3 organization. 4 Has any of your 5 subordinates or co-workers ever expressed any 6 reservations or questions about the efficacy 7 of Paxil to you? In other words, a comment, 8 such as, God, we are getting a lot of 9 complaints about Paxil. I wonder if they are 10 valid or not. That's my hypothetical. 11 Have you ever heard any 12 concern expressed by fellow SmithKline workers 13 on whether the critics of the drug may be 14 correct? 15 A. No. 16 MR. PREUSS: In terms of 17 efficacy? That's how you started your 18 question. 19 MR. FARBER: I will keep it 20 to the suicide issue. 21 THE WITNESS: No, I have 22 never heard that. 23 BY MR. FARBER: 24 Q. I will go back to Exhibit 18, and you 25 can use this, but the memo from -- call from 0097 1 Martin Brecher on the issue of whether the 2 suicide allegations against SSRI's is a public 3 affairs issue or not. And being from your 4 media background, whether -- 5 A. I should clarify. My media background, 6 my responsibility in media was for the 7 purchase of advertising space. It wasn't 8 corporate communications. 9 Q. Okay, but in your current job, do you 10 consider the Paxil and suicide allegation to 11 be a public relations or marketing problem? 12 A. I don't believe that there is an issue 13 with suicide and Paxil. 14 Q. I appreciate that. I would expect that, 15 but my question was on public relations. You 16 can believe that Paxil was a great drug 17 yourself. 18 A. The company does not believe. 19 Q. I'm sure the company believes it, too. 20 But the question of whether there is still 21 critics of Paxil and SSRI's out there, right, 22 so to that extent, there could be a public 23 relations problem with the suicide question. 24 Do you agree with that 25 proposition? 0098 1 A. There has not been a problem that I am 2 aware of. 3 Q. You are not aware of articles, 4 presentations on 20/20 and 60 Minutes about 5 the possibility of SSRI's -- and I think the 6 piece was specifically on Prozac, but whether 7 SSRI's induced suicidality? 8 A. I am aware there was coverage. 9 Q. You are aware of that general issue. 10 And do you view that issue 11 as a public relations or marketing problem for 12 SmithKline in your daily duties now? 13 A. No. 14 Q. There is not a problem, okay. 15 A. I don't believe -- 16 MR. PREUSS: There is no 17 question. 18 BY MR. FARBER: 19 Q. Now, earlier, you mentioned an 800 20 number. We talked about physician reporting, 21 and at least I will raise the issue of 22 pharmacists reporting, and let's add patients, 23 disgruntled patient reporting. 24 So this 800 number you 25 referred to earlier from the web site and so 0099 1 forth is, there is a hot line or some sort of 2 an 800 number, where potential critics of 3 Paxil can call in to the company; correct? 4 A. Anyone can call it, yes. 5 Q. Who gets this call? What office takes 6 this 800 call? 7 A. I'm not sure. 8 Q. It is not your organization? 9 A. The company that takes the calls? No. 10 Q. What knowledge do you have about the 11 system of the 800 number and what happens to a 12 complaint? 13 A. Limited. I know it is an organization 14 that provides an approved piece of information 15 by medical and regulatory. 16 Q. And I think you had mentioned earlier 17 that there was possibly follow-up actions that 18 were initiated when an 800 complaint came in? 19 A. I'm not sure what you are -- I think you 20 are referring back to product information, the 21 Product Information Department? 22 Q. I don't know what department, but I 23 think you had cited two examples of what could 24 happen when a call comes in as to whether the 25 matter is investigated. 0100 1 A. That would be if a representative was 2 unable to answer a question during a sales 3 call about a product. If he was unable to 4 answer, then he would put the physician in 5 touch with someone from Product Information. 6 Q. Yes, I understood that. I wasn't 7 referring to where the sales consultant 8 couldn't answer the question. I was concerned 9 about the situation where somebody off the 10 street, either a physician, a pharmacist or a 11 patient would call in directly to the 12 company. 13 A. They would probably get referred to a 14 physician or Product Information. 15 Q. Are there special procedures that -- 16 maybe you don't know -- special procedures 17 that have to be followed up on, once a call or 18 complaint is received? 19 A. I don't know. 20 Q. If I wanted to know how many outside 21 complaint calls have been submitted to 22 SmithKline directly since 1993 until now, what 23 organization or employee would I go to for 24 that information? 25 A. Outside complaint calls about -- 0101 1 Q. Take my 800 number scenario. Of all the 2 800 calls since 1993, on any issue, adverse 3 experience, discontinuation syndrome, 4 complaining about the price, whatever, what 5 organization at SmithKline Beecham would I go 6 to to get that information? 7 A. I'm not sure if it is collected 8 centrally. 9 Q. But whether it is or not, what -- 10 A. Product Information, Medical. 11 Q. Product information? 12 A. Medical would probably have a log. 13 Q. All right, Product Information and 14 Medical. And who is the head of Product 15 Information? 16 A. Chuck DePew. 17 Q. Chuck? 18 A. DePew, D-E-P-E-W. 19 Q. And who is the head of Medical? You 20 used the term Medical as the second possible 21 organization that would collect this 22 information and record it. 23 A. Yes. 24 Q. Can you give me -- it doesn't have to be 25 the top guy or gal, but one of the senior 0102 1 people in that organization. 2 A. Well, gosh, I am blanking on his name, 3 our head of Medical. 4 Q. Okay, well, take your time. 5 A. I'm sorry. I'm drawing a blank. 6 MS. PARRY: Do you need a 7 break? 8 MR. FARBER: You mentioned 9 there was two, three minutes on the tape? 10 MS. PARRY: Excuse me for 11 asking. I was concerned she was not feeling 12 well. 13 MR. FARBER: The tape is 14 almost done. Let's take a little break. 15 THE VIDEO TAPE OPERATOR: 16 Going off the video record. The time is 17 3:04. This concludes Tape Number 1. 18 THE VIDEO TAPE OPERATOR: 19 Back on the video record. The time is 3:21, 20 the beginning of Tape Number 2. 21 BY MR. FARBER: 22 Q. We are back on the record. And I don't 23 know whether you recall the Medical name you 24 were trying to think of. If not, it is okay. 25 A. We never established it. Who is the 0103 1 head of Medical? 2 Q. Do you recall a senior name? 3 A. I'm sorry. I am drawing a complete 4 blank. 5 Q. Okay, if you can't, you can't. 6 New subject. When was the 7 last time that you received or SmithKline 8 received a false and misleading allegation 9 from the FDA? 10 A. When was the last -- 11 Q. In whatever form, whether it is a more 12 formal letter, like we showed earlier in the 13 three exhibits? 14 A. I would have to check the records to 15 confirm that. 16 Q. I understand that, but in your general 17 knowledge, was it in the last three years, at 18 least one? 19 A. If there is a document, I would be happy 20 to look at it to provide you with an accurate 21 answer. I honestly do not remember the last 22 communication from -- from the FDA? 23 Q. Yes, from the FDA. 24 A. Yes. 25 Q. I know if I had a document, I would give 0104 1 it to you right now, but do you have any 2 knowledge at all in your brain of that subject 3 and the last time you received such a 4 document? 5 A. I don't remember the last time we 6 received a document. The letter would have 7 come to regulatory. 8 Q. I understand that. That's the way they 9 operate with government agencies, isn't it? 10 A. Yes. 11 Q. In 1998, early 1998, do you remember an 12 incident in Florida, in which a Paxil T-shirt 13 caused a flap? 14 A. I remember an incident where a 15 representative acted on his or her own that 16 resulted in a communication from the FDA. 17 Q. Yes. 18 And isn't it true that the 19 first response given by SmithKline Beecham to 20 the FDA on that FDA concern was inaccurate? 21 A. I don't know if that's true. 22 Q. I have two letters here, Exhibit 27 -- 23 that's why I asked you. I will need copies of 24 these. I only have single copies -- and 28, 25 which are letters respectively from SmithKline 0105 1 Beecham back to FDA, dated respectively March 2 20, 1998 and April 2, 1998. 3 - - - 4 (Whereupon the court 5 reporter marked documents as Exhibits 27 and 6 28 for identification.) 7 - - - 8 BY MR. FARBER: 9 Q. Take your time. There are two letters 10 there. They are fairly long. I will wait a 11 couple of minutes. 12 A. Thank you. 13 Q. Now, Ms. Rossello, I had given you two 14 SmithKline letters, and I didn't give you, 15 because I don't have it in my immediate 16 presence, is an FDA letter or communication 17 was bracketed in between those two letters. 18 Does that refresh your 19 memory as to this incident? 20 A. These two letters do, yes. 21 Q. And do you recall the incident in 22 general; correct, as you have testified? 23 A. Yes. 24 Q. And the alleged violator of that, let's 25 take the man or woman at the bottom who did 0106 1 that, who distributed those T-shirts. 2 It is obvious the first 3 response given by SmithKline to the FDA was 4 inadequate. Is that a fair conclusion from 5 that second letter? 6 MR. PREUSS: I object, 7 assuming facts not in evidence, particularly, 8 in the absence of the FDA letter in between. 9 BY MR. FARBER: 10 Q. Good objection. My question is, why was 11 the second letter phrased as it was, to your 12 knowledge? I know you didn't write the 13 letter, but it is from SmithKline, and why was 14 that second letter written in the -- with the 15 language that it was? 16 A. It would appear by the last paragraph of 17 the letter that we had not completed the 18 investigation at the time of the first 19 letter. 20 Q. Now, was that alleged violator working 21 within your organization? 22 A. No. 23 Q. What organization -- who was the 24 violator? 25 A. I don't know. It was a sales 0107 1 representative, it would appear. I don't know 2 the individual's name. 3 Q. Who would have been the immediate 4 supervisor of the alleged violator? 5 A. I don't know. 6 Q. Assuming it happened in Bavard County, 7 Florida, as it states, who would have been the 8 alleged violator's supervisor? 9 A. I don't know who the district sales 10 manager would be in Bavard County. 11 Q. But whoever that individual would be, it 12 would be that person; correct? 13 A. Um-hum. 14 Q. And what region is that identified as? 15 Middle Atlantic or Southern Atlantic or what's 16 the name of the region? 17 A. The Florida region. 18 Q. And who is the head of the Florida 19 region today? 20 A. Today, that would be Milt Ambrose. 21 Q. Milt? 22 A. Milt. 23 Q. Like Milton? 24 A. Yes. 25 Q. Amber? 0108 1 A. Ambrose. 2 Q. Ambrose, okay. 3 Was Mr. Ambrose the 4 director back at the time of this incident? 5 A. No. 6 Q. Who would have been the supervisor at 7 the time of the incident? 8 A. I would have to check the record to see 9 who that was. There have been several people 10 in that job since then. 11 Q. Were you advised when the company 12 received the first communication from FDA on 13 that T-shirt allegation? 14 A. I remember being made aware of this 15 T-shirt incident. I can't tell you where in 16 the chronology or when in the chronology it 17 was brought to my attention. 18 Q. And what was your reaction in your 19 professional duties at the time you were first 20 notified of that? 21 A. It was not my responsibility. This was 22 a rep acting on his own. It was the 23 responsibility of the sales management 24 organization to reprimand the representative. 25 Q. Sales management organization, okay. I 0109 1 guess we will have a little procedural 2 question. I'm sure it is an honest issue. I 3 would have thought that the marketing -- no 4 reflection on you -- that the marketing job or 5 marketing responsibility for this witness 6 would have included that, sales, I would 7 think, but we will solve that later. 8 So you don't know who the 9 individual violator, alleged violator, was or 10 is? 11 A. No. 12 Q. Did you hear of any disciplinary actions 13 initiated against that individual? 14 A. I believe there was disciplinary action 15 taken. 16 Q. What was that action? 17 A. I don't know. 18 Q. And when you say disciplinary action, 19 what, a letter of warning? 20 A. I don't know what the specifics were. 21 Q. Do you know if that individual is 22 employed by SmithKline today? 23 A. I don't know who they were, no. 24 Q. Was there more than one? 25 A. The letter states that this is an 0110 1 isolated incident involving two sales 2 representatives acting outside of SmithKline 3 Beecham's policies. 4 Q. And you are correct. I'm sorry. There 5 is two people in that letter. I talked about 6 a person. 7 Do you know if disciplinary 8 action was commenced against both persons? 9 A. No, I don't know. 10 Q. One or the other or both? 11 A. I believe that disciplinary action was 12 taken. I don't really know to what extent, 13 whether -- I don't know who the individuals 14 are or whether or not they are still employed 15 by the company. 16 Q. Now, Mr. Vickery asked you certain 17 questions about budgeting, and kind of an 18 extension of that, that type of incident at 19 the fair, where T-shirts were handed out, what 20 particular budget would that have been part 21 of? 22 A. What budget would what have been part 23 of? 24 Q. Let's just take an example of that. 25 Let's just say 100 Paxil T-shirts were printed 0111 1 up, nice $5 T-shirts. 2 Was that budget part of 3 what -- what's the name of that budget? 4 A. I don't know where that funding came 5 from. That was not a centrally approved 6 activity. 7 Q. Is there some sort of a general budget, 8 like miscellaneous supplies or petty cash or 9 something that that -- 10 A. There are field funds provided by sales 11 management to the sales floors. 12 Q. That sounds like that it was probably 13 the type of fund it was funded out of? 14 A. I don't know. 15 Q. Field funds. 16 To your knowledge, has 17 there been any repeat of violations of any 18 sales consultants on false and misleading 19 representations since that incident? 20 A. To the best of my knowledge, there has 21 not. 22 Q. I'm shifting subjects now to talking 23 about compensation and issues under, if not 24 marketing, if not your responsibility, but 25 perhaps related, and I'm asking about 0112 1 preferred drugs and marketing and that general 2 process of salesmanship and marketing that Mr. 3 Vickery was talking about. And taking it one 4 step further to a visit to a general 5 physician, PCP, physician, who you would like 6 to promote Paxil to, so he or she could 7 promote the drug to the patients. 8 What enticements or 9 incentives are offered to this -- let's make 10 it a little simpler. Let's take a general 11 practitioner, small town, one doctor, private 12 practice, general practitioner, no specialty. 13 If you would approach that 14 physician and try to promote Paxil for his 15 practice, what rewards or considerations or 16 offerings do you give that physician? 17 A. What rewards -- 18 MR. PREUSS: I object to 19 the form, assuming facts not in evidence. 20 MR. FARBER: It was 21 triplicate. 22 BY MR. FARBER: 23 Q. What enticements do you offer that 24 general practitioner to promote Paxil? 25 MR. PREUSS: Same 0113 1 objection. 2 THE WITNESS: I'm sorry. 3 Define enticements. I'm not sure what you 4 mean. 5 BY MR. FARBER: 6 Q. Okay, I will give you some examples of 7 enticements. First of all, let's start with 8 the lowest form, and that's free samples, free 9 samples. 10 A. I wouldn't characterize samples as 11 enticements. 12 Q. Okay, we have a difference of opinion on 13 that, but I won't confront that. 14 What about indemnification 15 for lawsuits? You would agree with me that if 16 you agreed to cover a physician being sued 17 because Paxil was prescribed, and the patient 18 sued the doctor and so on and so forth, that 19 indemnification for the doctor in such a suit 20 would certainly be an enticement. I allege 21 that. 22 And my question is, has 23 SmithKline ever offered indemnification to any 24 health care provider to prescribe Paxil? 25 A. To the best of my knowledge, no. 0114 1 Q. Has that subject of indemnification of 2 health care providers ever been discussed in 3 your presence? 4 A. No. 5 Q. Do you know of any instances where a 6 health care provider has been indemnified by 7 SmithKline Beecham directly or indirectly as a 8 result of being sued by a patient? 9 A. I know of no cases. 10 Q. Moving on to your television ads, 50 11 million, you said approximately. Is that an 12 annual budget? 13 A. For both the print and the television 14 campaign. 15 Q. Okay, print, electronic media. You gave 16 the proportion, but I didn't catch it. Of the 17 50 million, what percentage -- 18 A. Yes, I'm guessing now. 19 Q. I know. What was the figure you had 20 given? 21 A. It would be in the range of 60 to 70 22 percent would be -- 23 Q. Maybe 70, because television is very 24 expensive; especially, national television. 25 I saw your ad watching The 0115 1 World Series, and national, I guess, or excuse 2 me, lead play-off series on Fox, and I saw 3 this ad before on other things, and there was 4 a phrase in the ad called, Paxil is not for 5 everyone. 6 Are you familiar with that 7 phrase? 8 A. I am. 9 Q. When was that phrase inserted into your 10 electronic advertising? 11 A. Are you speaking now of the consumer 12 advertising? 13 Q. Yes, the television, the electronic ads, 14 the phrase, Paxil is not for everyone. 15 MR. PREUSS: What is the 16 question? 17 BY MR. FARBER: 18 Q. When was that phrase inserted into the 19 electronic ads to which I speak? 20 A. It is my recollection that it was there 21 from the beginning. 22 Q. That's not my recollection, but that's 23 your testimony. That's fine. 24 And when was that ad 25 formulated? 0116 1 A. It was developed over the course of 2 1999, the original ad. 3 Q. Early '99? 4 A. Yes. We are speaking of the original 5 campaign now or the one that's running 6 currently? 7 Q. The one running currently. 8 A. That was developed this year. 9 Q. Yes, I remember a couple of ads. The 10 first one I saw was on the Bill Maher, 11 Politically Incorrect. 12 And do you remember when 13 Bill Maher or his network was first contacted 14 on that ad? When did that begin, the ad that 15 was placed on The Bill Maher Show? 16 A. I don't know The Bill Maher Show. The 17 ads were originally placed by a media agency 18 back in November of 1999. 19 Q. Originally in November. 20 And before November of '99, 21 were there any national network electronic ads 22 on Paxil? 23 A. Any television ads? 24 Q. Yes, let's keep it to television. 25 A. No. 0117 1 Q. And what was the ad -- what was the 2 agency responsible for putting that ad 3 together? 4 A. McCann-Erickson. 5 Q. McCann-Erickson? 6 A. Um-hum. 7 Q. And what is their location? 8 A. Manhattan. 9 Q. Now, back to the phrase, Paxil is not 10 for everyone, as far as you know, that was 11 inserted at the very beginning, November of 12 '99? 13 A. I recall that in the first ad. That's 14 my recollection. 15 Q. And who inserted that phrase under the 16 ad? 17 A. I don't remember. It could have been 18 any number of people who participated in the 19 development of the ad and reviewed it. It 20 could have been somebody from medical, someone 21 from regulatory. It was approved by the FDA. 22 But I don't recall. 23 Q. That ad, let's take the first ad, 24 November of '99 as being the only ad for 25 purposes of my question. 0118 1 Are these ads screened by 2 the CEO of SmithKline Beecham? 3 A. The CEO saw that ad. 4 Q. And he approved it? 5 A. He did. 6 Q. I don't know this. I should know it, 7 but I don't. The chairman of the board is 8 different than the CEO; correct? 9 A. The CEO is J.P. Garnier. 10 Q. He is not chairman of the board? 11 A. He is chairman. 12 Q. He has the same dual hat, okay. 13 A. At the time, the chairman was Yan 14 Leshlie. 15 Q. Now, other than that ad, what other 16 electronic ads have been placed into the 17 stream of commerce since 1998? 18 A. To consumers or -- 19 Q. Let's broaden it to print media. 20 A. To consumers or physicians? 21 Q. Consumers. 22 A. Just to consumers. There has been a 23 print ad that also has appeared. 24 Q. I have seen your print ad in TV Guide. 25 And take national print media. Other than TV 0119 1 Guide, what periodicals place the Paxil ads in 2 their print? 3 A. Which magazines? 4 Q. Yes, any print media. New York Times, 5 TV Guide, Newsweek, whatever. Name three or 6 four, if you can. 7 A. Newsweek, Time. 8 Q. And is that selection based upon the 9 recommendation of the Manhattan agency? 10 A. It is based on the recommendation of SB 11 Consumer in Pittsburgh. 12 Q. Of what? 13 A. SB Consumer. 14 Q. SB Consumer? 15 A. Yes, SmithKline Beecham, the Consumer 16 Division. 17 Q. Oh, okay, in Pittsburgh, Pennsylvania? 18 A. Um-hum. 19 Q. Now, in the selection of the ads, are 20 there trained -- correction. 21 In the selection of these 22 ads, are there psychologists or other mental 23 health professionals consulted on advertising 24 techniques? 25 A. Are there -- are there psychologists 0120 1 consulted on where to place the ads? 2 Q. Not where, the content of the ads. 3 A. Our own physicians, and yes, we review 4 the ads with a number of physicians on the 5 outside, marketing research, as part of the 6 process, test the ad with physicians, yes. 7 Q. Did you see Doctor Wheadon on 20/20 on 8 August 25th, 2000? 9 A. I did not see him. 10 Q. When was his presence on that TV show 11 approved by SmithKline? 12 A. I don't understand the question. 13 Q. Well, he appeared on 20/20 on August 14 25th, did he not? 15 A. Right, yes. 16 Q. And it was filmed some time prior to 17 that; correct? 18 A. I don't know when it was filmed. I was 19 not part of that. I don't know when it was 20 filmed. 21 Q. Who would have -- who did make the 22 decision for Doctor Wheadon personally to 23 appear on that show? 24 A. I would imagine Corporate Communications 25 were contacted, and then, they, in turn, 0121 1 contacted Doctor Wheadon. But I don't know 2 this to be -- I'm not certain about this. 3 Q. Was there any internal memorandums or 4 communications promulgated on what Doctor 5 Wheadon's commentary was on that show? 6 A. I didn't see any. 7 Q. Do you know of any? 8 A. Prior to his appearance on the -- 9 Q. Well, let's just take it after. I'm 10 just doing it for the background of when a 11 prominent person from an organization appears 12 in the media or interviewed that, often, the 13 commentary is promulgated by -- 14 A. So was there a transcript produced? 15 Q. Well, within SmithKline is my comment. 16 I'm sure ABC has a transcript, but as far as 17 reproducing and promulgating to the troops 18 what Doctor Wheadon said on 20/20, was -- 19 A. There may have been -- Corporate 20 Communications probably provided a transcript 21 to Doctor Wheadon. 22 Q. But how about for availability to the 23 population of SmithKline in general? 24 A. No, I don't believe so. 25 Q. Like no e-mail, no general e-mail 0122 1 distribution or -- 2 A. I don't believe there was a general 3 distribution. 4 Q. Do you know if any adverse experiences 5 in general, whether it be suicide, addiction 6 or discontinuation syndrome or sweating or any 7 of the adverse experiences had a role in 8 selecting the ads that have been issued as we 9 have discussed, both print ads and electronic 10 ads? 11 MR. PREUSS: I object to 12 the form. 13 THE WITNESS: I'm not sure 14 what you mean. 15 BY MR. FARBER: 16 Q. Okay, I think it is a bad question. The 17 background you mentioned, a lot of people are 18 consulted before finalizing the content of 19 these ads, both print and electronic, right? 20 A. Yes. 21 Q. And there is a lot of angles covered in 22 here, like Paxil is not for everyone. It 23 sounds like a lawyer's input to me. But there 24 are other inputs as well, general anxiety, 25 social phobia, and there are various inputs, 0123 1 is there not? 2 A. I'm not sure what you mean by angles. 3 MR. PREUSS: There is no 4 question. 5 BY MR. FARBER: 6 Q. I'm trying to provide the foundation and 7 the background here. And the first question 8 was, do you have knowledge that certain 9 adverse experiences by Paxil patients from the 10 original clinical trials right up to 1998 had 11 a role in the content of those ads? 12 A. Are they the reason? Is that what you 13 are asking? 14 Q. Not the reason, but a reason? 15 A. No. 16 Q. I have one final inquiry, and then I 17 think I will be done. And back to the 800 18 number and the complaints and so forth, with 19 your dual answer of the fact that the medical 20 division and what was the -- the other one was 21 the Product Information Division, it seems to 22 me like there is not one standard system or 23 one entity -- 24 A. There is a standard system for safety. 25 I'm sorry. I have cut you off. I apologize. 0124 1 Q. That's okay. I have cut you off 2 enough. You can cut me off. 3 That there is not one 4 entity that is responsible. That's my 5 opinion. But in any event, when this 800 call 6 comes in, it is answered by -- somewhere in 7 the company, right? An operator or a -- 8 A. Yes. I'm not sure where that operator 9 resides. And I should clarify. When you said 10 complaints, I was putting questions, et 11 cetera, in that category. Any issue, any 12 safety issue is immediately reported, and that 13 information is collected by the safety 14 department. So there is definitely a one 15 source of information about safety issues that 16 arise on Paxil and any other drug that 17 SmithKline manufactures. 18 Q. Now, let me be on the other end for a 19 while. Let me object to the question. 20 When you say safety, to me, 21 I think of the definition that we have used 22 for ten years, and that's the difference 23 between safety and efficacy. I view those as 24 two different. 25 So my question would 0125 1 concern the broadest possible inclusion of the 2 term, whether it is safety, efficacy, the pill 3 is too expensive or anything. 4 Am I correct in assuming 5 that -- take all of these -- let's call them 6 complaints, that they call into the 800 7 number, that they come to one entity at 8 SmithKline initially? 9 A. There is an 800 number for the company, 10 which anybody can call. They could get 11 directed to a number of different people, 12 depending on what it is that they have a 13 question or issue with. 14 Q. Okay, and the -- where this call 15 initially comes into is where I am at now. 16 One of the sections or one 17 of the entities, to use a gender term, mans 18 the telephone, right? And they receive the 19 call. And then, according to your testimony, 20 it is then directed to the proper division to 21 handle that particular issue? 22 A. If it comes in through the 800 number 23 for SmithKline, that's right. That's one 800 24 number. There is another 800 number. 25 Q. Let's call that the complaint 800 0126 1 number. 2 A. It really is not the complaint. It is a 3 number that anybody can call to reach anybody 4 at SmithKline Beecham. 5 Q. We will call it the any 800 number, 6 okay. 7 A. It is the main number. 8 Q. The main 800 number, okay. 9 Now, what is another 800 10 number that you could call for -- 11 A. There is an 800 number that a physician 12 can call for product information. 13 Q. I'm not talking about that one. I don't 14 care about that one today, because I know like 15 HMO's or physicians or drugs -- people can 16 call in a special number. I'm not talking 17 about that one. I'm talking about the main 18 800 number. 19 So what division handles 20 the main 800 number? 21 A. Those calls would come into a 22 receptionist and an operator, and depending on 23 what the question or issue was, they would be 24 directed to the people who would be most able 25 to help. 0127 1 Q. That's very logical. Thank you. 2 And basically, a telephone 3 operator, for the lack of a better term, 4 right? 5 A. Yes. 6 Q. And what division is that telephone 7 operator assigned to? 8 A. I don't know. 9 Q. General administration or somebody that 10 handles general administration, I would think, 11 right? 12 A. Yes. 13 Q. Now, do you happen to know whether that 14 operator is given any company instructions on 15 how to handle these calls, such as you just 16 mentioned, that, well, if it comes in on a 17 medical issue, you refer it here, if it comes 18 in on this -- so she has to have some training 19 or instructions to perform her duties; 20 correct? 21 A. I would imagine. 22 Q. Do you happen to know whether this 23 operator or series of operators has written 24 instructions on how to -- 25 A. I don't know what those instructions 0128 1 are. 2 Q. So is that the extent of your knowledge 3 of this general subject, what you just 4 testified to? 5 A. The extent of my knowledge on what? 6 Q. On the 800 number process and 7 procedures. It is not a trick question. I'm 8 just trying to say, is this all you know on 9 that subject? 10 A. I know when someone calls into the -- 11 yes. 12 MR. FARBER: Okay, that's 13 what I was expecting to hear. That's all I 14 have. Do you have anything else? 15 MR. VICKERY: Very few. Do 16 you want to take a break before? 17 THE WITNESS: No, I'm 18 fine. 19 - - - 20 EXAMINATION 21 - - - 22 BY MR. VICKERY: 23 Q. Ms. Rossello, do you have a Speakers' 24 Bureau? 25 A. SmithKline has a Speakers' Bureau, yes. 0129 1 Q. Are these the doctors that you were 2 discussing with Mr. Farber who regularly speak 3 on behalf of your company and on behalf of 4 Paxil? 5 A. The Speakers' Bureau is a broader group 6 of physicians who speak on behalf -- the group 7 I was referring to were consultants. It is a 8 much smaller group of people. 9 Q. I'm confused, I guess. Help me out. 10 What's the Speakers' Bureau? 11 A. The Speakers' Bureau is a significant 12 number of physicians to whom we provide 13 information about our drug, so that a 14 representative can call upon one of these 15 speakers, and they can speak to a group of 16 physicians. 17 Q. Do you try to have a regular speaker 18 like that in each geographic area? 19 A. It probably works out that way. 20 Q. Are the funds for doing that sort of 21 discretionary with the local sales rep? 22 A. The funds, the sales rep -- I need to 23 think about how the sales rep accesses that. 24 Sales reps are allocated -- a region is 25 allocated a certain amount of money for 0130 1 speakers' meetings. 2 Q. Okay, so then the regional manager would 3 divvy that up among his sales reps? 4 A. That's right. 5 Q. And then the sales rep can use that 6 money to compensate any speaker he or she 7 wants within their territory? 8 A. Yes. 9 Q. Is the typical compensation about $300 a 10 pop? 11 A. It ranges between 750 and 1,000. 12 Q. Now, do you know whether or not there 13 have been any kind of arrangements, Speakers' 14 Bureau arrangements or other financial 15 arrangements between your company and Doctor 16 Patel? 17 A. I don't know Doctor Patel. 18 Q. He is the physician who prescribed Paxil 19 for Mr. Shell in Cheyenne, Wyoming in the 20 Tobin case that we are here on today. 21 A. I don't know Doctor Patel. 22 Q. You don't know that? 23 A. No. 24 Q. How important are formularies, either 25 HMO's formularies or hospital formularies in 0131 1 terms of your overall marketing effort of 2 Paxil? 3 A. How important are they? 4 Q. Right. 5 A. Meaning what percentage of the marketing 6 focus is -- 7 Q. Sure. 8 A. Maybe 5 percent of the funding is 9 directed at developing programs for managed 10 care. 11 Q. Well, how about hospital formularies in 12 a non-managed care kind of setting? 13 A. I'm not certain how much funding is 14 devoted to that. 15 Q. Would you just explain in terms that 16 ordinary folks could understand what a 17 formulary is and how it helps your company for 18 your drug to be on one? 19 A. A formulary is a listing of drugs that 20 are available to patients who belong to a 21 certain HMO and that are reimbursed by that 22 managed care organization. 23 Q. Now, is it typical in those kind of 24 arrangements for there to be only one SSRI 25 drug on the formulary? 0132 1 A. I would say it is more typical for 2 multiple numbers of drugs to be available. 3 Q. Is Paxil marketed as an alternative to 4 more traditional talking therapies for 5 depressed patients? 6 A. It is marketed as a treatment for those 7 illnesses for which it is indicated. 8 Q. I know that, but it is specifically 9 marketed to take the place of a talking 10 therapy? 11 A. No, I would not agree with that. 12 Q. No? Isn't that how you all kind of try 13 to persuade HMO's and hospital formularies to 14 accept Paxil? Say, in essence, it is cheaper 15 to treat patients by giving them these pills 16 than to allow them to go and talk out their 17 problems with a therapist? 18 A. No, that is not how we market. I mean, 19 that is the physician's decision, how -- it is 20 an individual physician's decision how an 21 individual patient would be best treated for 22 whatever illness they suffer, and that might 23 include a course of psychotherapy. We would 24 not recommend that. 25 Q. And your company does absolutely nothing 0133 1 to encourage the use of Paxil in lieu of 2 traditional talking therapies? Is that your 3 testimony? 4 A. That's my testimony. 5 Q. I want to follow up with one final 6 inquiry concerning this direct to consumer 7 advertising. I saw, I think, last year, in 8 The Wall Street Journal, a report that 9 approximately 84 percent of patients who go 10 into a doctor and ask for a specific drug by 11 name walk out with a prescription for that 12 drug. 13 Does the marketing 14 information that you have pretty much comport 15 with that? 16 A. I have seen numbers in that range, yes. 17 Q. And is that why you all are willing to 18 spend the 50 million bucks in direct to 19 consumer advertising, so folks will ask for 20 Paxil by name? 21 A. To make patients aware -- I mean, our 22 basic feeling is, there are a lot of people 23 out there that are suffering from this 24 disease, social anxiety disorder, and that we 25 can help them by making them aware of this 0134 1 disorder. 2 You know, ultimately, they 3 are going to -- if they seek help from their 4 physician, that would be his decision what 5 medication they get. 6 Q. Right, but what you know going in is 7 approximately 84 out of 100 people who become 8 aware as a result of that ad, and who thereby 9 walk into the doctor's office and seek 10 treatment and ask for Paxil by name will get 11 it; true? 12 A. I don't have a model that would predict 13 that. I can't tell you that 84 percent of 14 people that have gone in to talk to physicians 15 and asked for a drug or Paxil by name have 16 received a prescription for Paxil. 17 Q. Well, I wasn't trying to be all that 18 precise with it, I guess. I mean, it is in 19 that ballpark, isn't it? You know, from your 20 marketing research and your experience, that 21 somewhere in that range of 80 to 90 percent of 22 the people who ask for Paxil by name will get 23 it? 24 A. There is general information to suggest 25 that a patient who asks for a drug, that 84 0135 1 percent of those patients will get it. We 2 don't know that to be the case with Paxil. 3 Q. Oh, I see. It is like the experience 4 across the board for all drugs? 5 A. Yes. 6 MR. VICKERY: That's all I 7 have. Thank you. 8 THE VIDEO TAPE OPERATOR: 9 Going off the video record. The time is 10 4:01. This concludes today's video tape 11 deposition. 12 13 14 15 16 17 18 19 20 21 22 23 24 25 0136 1 C E R T I F I C A T E 2 - - - 3 STATE OF NEW JERSEY : 4 : SS 5 COUNTY OF BURLINGTON : 6 7 I, Jeanne Christian, 8 Court Reporter-Notary Public within and for 9 Burlington County, Commonwealth of New Jersey, 10 do hereby certify that the foregoing testimony 11 of Bonnie S. Rossello was taken before me at 12 2600 One Commerce Square, Philadelphia, 13 Pennsylvania on Thursday, October 19, 2000; 14 that the foregoing testimony was taken in 15 shorthand by myself and reduced to typing 16 under my direction and control, that the 17 foregoing pages contain a true and correct 18 transcription of all of the testimony of said 19 witness. 20 21 22 ..................... JEANNE CHRISTIAN 23 Notary Public 24 My Commission expires 25 May 21, 2003 0137 1 INSTRUCTIONS TO WITNESSES 2 Read your deposition over carefully. It 3 is your right to read your deposition and make 4 changes in form or substance. You should 5 assign a reason in the appropriate column on 6 the errata sheet for any change made. 7 After making any change in form or 8 substance which has been noted on the 9 following errata sheet along with the reason 10 for any change, sign your name on the errata 11 sheet and date it. 12 Then sign your deposition at the end of 13 your testimony in the space provided. You are 14 signing it subject to the changes you have 15 made in the errata sheet, which will be 16 attached to the deposition before filing. You 17 must sign it in front of a witness. Have the 18 witness sign in the space provided. The 19 witness need not be a notary public. Any 20 competent adult may witness your signature. 21 Return the original errata sheet & 22 transcript to deposing attorney, (attorney 23 asking questions) promptly! Court rules 24 require filing within 30 days after you 25 receive the deposition. Thank you. 0138 1 I have read the foregoing 2 deposition and the answers given by me are 3 true and correct, to the best of my 4 knowledge and belief. 5 6 7 8 ...................... BONNIE S. ROSSELLO 9 10 ....................... Witness to signature 11 ....................... 12 Address 13 My Commission expires 14 ...................... 15 16 17 18 19 20 21 22 23 24 25 0139 1 ERRATA SHEET 2 PAGE LINE # CHANGE REASON THEREFOR 3 _______________________________________________ 4 _______________________________________________ 5 _______________________________________________ 6 _______________________________________________ 7 _______________________________________________ 8 _______________________________________________ 9 _______________________________________________ 10 _______________________________________________ 11 _______________________________________________ 12 _______________________________________________ 13 _______________________________________________ 14 _______________________________________________ 15 _______________________________________________ 16 _______________________________________________ 17 _______________________________________________ 18 _______________________________________________ 19 _______________________________________________ 20 _______________________________________________ 21 _______________________________________________ 22 _______________________________________________ 23 _______________________________________________ 24 _______________________________________________ 25 _______________________________________________