1 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA 2 - - - 3 TOBIN, et al : Plaintiff : 4 : VS. : NO: 00CV0025 5 : SMITHKLINE BEECHAM : 6 Defendant : 7 - - - 8 Video deposition of IAN R. B. 9 HUDSON, M.R.C.P., M.D., taken pursuant to 10 notice, held at 2005 Market Street, 36th 11 Floor, Philadelphia, Pennsylvania, 19103, on 12 Friday, December 15, 2000, beginning at 13 approximately 9:38 a.m., before Lorraine M. 14 Edwards, Court Reporter and Notary Public, in 15 and for the State of New Jersey, and Michael 16 Moeller, Videotape Operator, there being 17 present. 18 - - - 19 APPEARANCES: PREUSS, SHANAGER, ZVOLEFF & 20 ZIMMER BY: CHARLES F. PREUSS, ESQUIRE 21 225 Bush Street, 15th Floor San Francisco, California 94104 22 Phone: (415) 397-1730 Representing SmithKline Beecham 23 STOEL RIVES 24 BY: JOHN A. ANDERSON, ESQUIRE 201 South Main Street, Suite 100 25 Salt Lake City, Utah 84111 Phone: (801) 578-6930 SPHERION DEPOSITION SERVICES 1-713-650-3500 2 1 Representing SmithKline Beecham APPEARANCES CONTINUED: 2 SMITHKLINE BEECHAM 3 BY: ANDREA L. PARRY, ESQUIRE One Franklin Plaza 4 Philadelphia, Pennsylvania 19101 Phone: (215) 751-7022 5 6 VIA TELEPHONE: 7 VICKERY & WALDNER, LLP BY: ANDY VICKERY, ESQUIRE 8 2929 Allen Parkway, Suite 2410 Houston, Texas 77019 9 Phone: (713) 526-1100 Representing the Plaintiffs 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 SPHERION DEPOSITION SERVICES 1-713-650-3500 3 1 - - - I N D E X 2 - - - WITNESS 3 IAN R. B. HUDSON, M.R.C.P., M.D. 4 EXAMINATION PAGE 5 BY MR. VICKERY 5 6 7 8 9 10 11 12 13 - - - E X H I B I T S 14 - - - 15 NUMBER DESCRIPTION PAGE MARKED 16 HUDSON-1 CURRICULUM VITAE 8 17 HUDSON-2 AGGRESSION STUDY 12 18 HUDSON-3 ARTICLE BY ROGER LANE 48 19 20 21 22 23 24 25 SPHERION DEPOSITION SERVICES 1-713-650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 4 1 COURT REPORTER: Will Counsel 2 stipulate that the Witness may be sworn in by 3 an out-of-state New Jersey Notary? 4 MR. VICKERY: Yes. 5 MR. PREUSS: Yes. 6 MR. ANDERSON: Yes. 7 MS. PARRY: Yes. 8 - - - 9 (It is hereby stipulated by 10 and among Counsel for the respective parties 11 that the Witness may be sworn by an 12 out-of-state New Jersey Notary with full force 13 and effect.) 14 - - - 15 THE VIDEOTAPE OPERATOR: We 16 are on the video record. The Deponent today 17 is Dr. Ian Hudson. Today's date is December 18 15, 2000 and the time is 9:38. The Court 19 Reporter will now swear in the Witness. 20 - - - 21 IAN R. B. HUDSON, M.R.C.P., 22 M.D., after having been duly sworn, was 23 examined and testified as follows: 24 - - - 25 EXAMINATION SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 5 1 - - - 2 BY MR. VICKERY: 3 Q. State your name, please, sir. 4 A. Dr. Ian Hudson. 5 Q. Good morning, Dr. Hudson, again. We 6 spoke before we got on the record, but my name 7 is Andy Vickery and I'm a lawyer from Houston, 8 Texas, actually in Houston, Texas this morning 9 taking your deposition by telephone. Have you 10 ever had a deposition taken before? 11 A. No, I have not. 12 Q. Okay. What have you done to prepare 13 yourself for this deposition? 14 A. Met with Counsel during the course of 15 the last few days and discussed various 16 questions. 17 Q. What materials have you reviewed? 18 A. Counsel had provided me with various 19 materials relating to Paroxetine. 20 Q. Do those materials include the 21 Aggression Study that I have been provided? 22 A. Yes. 23 Q. Do they include the articles, a whole 24 series of them, that Mr. Zvoleff has sent the 25 abstracts or first pages to me? SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 6 1 A. I would need to see which ones you're 2 referring to. 3 Q. I can kind of go through them in a 4 minute, but did you read a whole series of 5 articles about SSRIs in general and 6 Paroxetine, in particular, with respect to 7 akathisia, suicide, violence and those issues? 8 A. I've looked at some articles on those 9 topics, yes. 10 Q. Dr. Hudson, prior to your preparation 11 for this deposition, had you ever made any 12 attempts to read the scientific literature on 13 whether, and to what degree, there is an 14 association or causal relationship between 15 SSRIs in general, or Paroxetine in particular, 16 and aggressive or suicidal behavior? 17 A. No. I would have delegated that to 18 staff within my department to review that 19 data. 20 Q. Okay. But this is your first occasion, 21 in other words, getting ready for the 22 deposition, to do that yourself. 23 A. To review the literature, yes. 24 Q. Now, I understand that one of the topics 25 that you are here for today -- well, actually, SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 7 1 let's be clear about it, that the topics 2 you're here to address are topics 2-B and all 3 of Topic 5 in my 30 (b)(6) Notice. Have you 4 gone over that with Counsel? 5 A. I would need to see which topics you're 6 referring to. 7 MR. PREUSS: I'm handing him 8 the designation. 9 MR. VICKERY: Okay. 10 THE WITNESS: Could you 11 restate the sections? 12 BY MR. VICKERY: 13 Q. Yes. I've been told you are there to 14 respond to Section 2-B. 15 MR. PREUSS: "B" as in "boy"; 16 right? 17 BY MR. VICKERY: 18 Q. "B" as in "boy", Psychological Autopsies 19 on patients who have committed acts of suicide 20 or violence while under the influence of 21 Paxil. 22 A. Right. 23 Q. And are you? 24 A. Yes. 25 Q. Then all of Section 5, main topic of SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 8 1 Section 5, is Adverse event reports concerning 2 patients who commit acts of suicide or 3 violence while under the influence of Paxil. 4 And then there are subheadings of A through D. 5 Are you there for those purposes? 6 A. Yes, I am. 7 Q. Dr. Hudson, I have reviewed your CV, and 8 I will ask the court reporter to mark a copy 9 of it as Exhibit One to this deposition. 10 - - - 11 (Exhibit Hudson-1 was marked 12 for identification and received into evidence 13 and is attached hereto.) 14 - - - 15 BY MR. VICKERY: 16 Q. In reviewing your CV, it appears that 17 you did not have any real direct relationship, 18 in your practice, with psychoactive drugs 19 until such time as you became Worldwide 20 Director of Safety for SmithKline in January 21 of '99; is that accurate? 22 A. Yes, that's correct. 23 Q. Since becoming Worldwide Director of 24 Safety in January of 1999, what effect or 25 activities have you had with respect to SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 9 1 Paroxetine or any other psychoactive drug that 2 is manufactured or marketed by SmithKline 3 Beecham? 4 A. I'm sorry. I'm not sure -- could you 5 repeat the question? 6 Q. Sure. Since January of '99, other than 7 your involvement as a witness in this case, 8 what, if anything, have you had to do with 9 Paxil? 10 A. My department is responsible for the 11 collection of adverse events that come in, the 12 serious adverse events and the spontaneous 13 reports and literature reports that come in on 14 Paxil, preparing analyses, whether they be 15 routine periodic safety update reports, U.S. 16 periodics, or whether they be specific 17 analyses on various topics on Paroxetine. And 18 so I've had involvement, from supervisory, and 19 in some cases direct involvement, in various 20 topics, safety topics related to Paxil. 21 Q. Have you, prior to the time that you 22 were named as a witness in this case, ever 23 spent any personal time -- I don't mean 24 personal time -- but, I mean, any of your time 25 personally on the issue of whether there is an SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 10 1 association or causal relationship between 2 Paxil and aggression or suicidality? 3 A. Yes. During the course of last year and 4 this year, we have been -- we have prepared 5 documents covering those topics and reviewed 6 data on that and I have reviewed documents 7 that have been prepared within my department 8 on those. 9 Q. Now, is one of those documents the 10 Aggression Study that has been provided to me 11 in draft form by a Mr. Cheng or is it 12 Dr. Cheng? 13 A. I would like to know which one you're 14 referring to. 15 Q. I'm referring to a sixty-three page 16 study. It's been provided to me by 17 Mr. Zvoleff via fax in the last day or two. 18 It's just titled "Aggression"; "Paroxetine" 19 "Aggression". Are you familiar with that 20 study? 21 MR. PREUSS: Would you like me 22 to give it to him? 23 MR. VICKERY: Yes, would you? 24 THE WITNESS: Thank you. 25 Yes. This is not a study. This is a review SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 11 1 of the data we have, but I'm familiar with 2 this document. 3 BY MR. VICKERY: 4 Q. What was the impetus of that document 5 being prepared? 6 A. We reviewed the topic of aggression last 7 year. At that time we said that we would keep 8 aggression under review. In addition, there 9 was considerable noise in the media earlier 10 this year about Fluoxetine. So having said 11 that we would keep this topic under review, we 12 rereviewed this topic this year and it was 13 also prompted by considerable concern being 14 expressed, considerable noise being expressed 15 in the media. There were a series of articles 16 in the "Guardian". 17 Q. Okay. Now, how about any Governmental 18 entity? I mean, was the MCA over in the 19 United Kingdom or the FDA here in any way 20 impetus for looking into this issue and 21 collecting this information? 22 A. No, it wasn't. This was on the basis of 23 internal monitoring. 24 Q. All right. Is Nicola Cheng a doctor? 25 A. No, she's a scientist who works within SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 12 1 my department. 2 Q. Did you specifically ask her to prepare 3 this report? 4 A. I asked people in my department to 5 prepare this report and she was delegated the 6 responsibility through her line manager. 7 Q. All right. I would like to ask our 8 court reporter to mark that report as Exhibit 9 Number Two. 10 - - - 11 (Exhibit Hudson-2 was marked 12 for identification and received into evidence 13 and is attached hereto.) 14 - - - 15 BY MR. VICKERY: 16 Q. Dr. Hudson, the copy I have been given 17 says "Draft". Is it still in draft form? 18 A. I'd need to confirm whether it's finally 19 been completed, had its reviews completed. It 20 was due to be reviewed finally this week and 21 unmented (phonetic) at the Labeling Committee 22 this week, but I haven't had an update as to 23 whether that has happened. 24 Q. What do you intend do with the report 25 once it's finalized? SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 13 1 A. The intentions of -- assuming everyone 2 is in agreement that there is no issue here, 3 the intentions would be that this would be 4 stored on file as a record of the review that 5 has been completed. 6 Q. Do you intend to submit it to any 7 governmental agency? 8 A. If a Government agency requests 9 information on aggression and Paroxetine, we 10 would, but we do not intend to proactively 11 send it to them at this stage. This was an 12 internal review. We do many internal reviews 13 on many topics. 14 Q. Do you intend to submit it to the peer 15 review process and seek publication of this 16 report in a peer review journal? 17 A. No, we do not. 18 Q. Why not? 19 A. Well, we review many topics on an 20 ongoing basis and we don't submit them all to 21 publication. This data is a constantly 22 changing source of information. It will be 23 out of date as soon as it were to appear in 24 press. We keep it on file and if we have 25 course to review the topic again, we would use SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 14 1 it at that stage. 2 Q. There are folks at SmithKline Beecham 3 who write articles on Paxil that are submitted 4 for peer review and publication; aren't there? 5 A. Not from within my department. I 6 believe there may be some others, but others 7 would be more appropriate to address that 8 question to. 9 Q. Okay. 10 MR. VICKERY: Mr. Preuss, I 11 need a clarification on one thing. The first 12 page of this document is marked 13 "Confidential". None of the other pages 14 are. Is this a confidential document or not? 15 MR. PREUSS: It is. 16 MR. VICKERY: Okay. We will 17 treat it as such. 18 MR. PREUSS: Thank you. 19 BY MR. VICKERY: 20 Q. Dr. Hudson, explain to me, if you would, 21 what the system is whereby SmithKline receives 22 reports of adverse events, how you, you know, 23 accumulate the data concerning those reports 24 and how you investigate them. 25 A. Okay. In terms of receipt of adverse SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 15 1 events, we will receive reports from many 2 sources, spontaneous reports phoned through to 3 the company or mentioned to sales reps or to 4 other people employed by the company. They 5 will all be sent through to the Clinical 6 Safety Function. These reports will be 7 reviewed by the Clinical Safety Function, will 8 be entered onto a database and will be 9 assessed by both scientists and physicians 10 involved in the receipt of these cases. They 11 will be then -- a decision will be made in 12 terms of whether the report meets the 13 requirements for expedite reporting and if it 14 does, it will be reported accordingly to the 15 regulatory authorities. 16 Q. All right. What attempt is there on 17 your company's part, first of all, to 18 ascertain whether the reporting doctor, 19 assuming it was a doctor that reported it, 20 believed that the adverse event being reported 21 was caused by Paxil? 22 A. Well, in the receipt of a report, we 23 will follow up with the reporter to obtain the 24 relevant information on the case. So, we will 25 want to obtain from him the medical history of SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 16 1 the patient, whether the patient is on any 2 other medication, et cetera, whether there 3 were any other circumstances that may have 4 been involved in the event. What's most 5 important to us, however, is the medical 6 history, the circumstances, were there any 7 other factors involved rather then whether he 8 thinks that the event was related or not. 9 Q. Are you telling me that the opinion of 10 the clinician who is treating the patient and 11 who prescribes the Paxil in the first place is 12 not an important consideration? 13 A. Well, if he believes that there are 14 other factors relevant, I would hope he would 15 tell us those other factors and we would 16 certainly ask him about those other factors. 17 So, his opinion is relevant in the sense of 18 are there other factors involved, but 19 regardless of what he thinks, we will record 20 this event, we will analyze this event and we 21 will deal with it appropriately. 22 Q. Now, my concern right now, and we'll get 23 into how you deal with it on your end, but my 24 concern right now is the clinical judgement of 25 the doctor who has treated the patient. Is SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 17 1 that something that SmithKline Beecham 2 considers important and that it recorded -- it 3 records with respect to such adverse event 4 reporting? 5 A. If they tell us their opinion, we will 6 record that in the narrative of the case. 7 Q. If they do not volunteer their opinion, 8 do you make any effort to obtain from them 9 their best clinical judgement about whether 10 the drug had any kind of association or causal 11 relationship with the adverse event? 12 A. Well, we have a policy for spontaneous 13 reports and decisions in relation to whether 14 we should be expediting them to the agencies 15 to assume that, in the mind of the reporter, 16 there may be some link, association, between 17 the event and the drug. 18 Q. So, are you telling me that if they do 19 not volunteer that information, that's 20 something that you ask them? 21 A. No, I didn't say that. I said that for 22 the purposes of our assessment, we assume that 23 in the mind of the reporter, he may be 24 thinking there is some association, otherwise 25 he wouldn't have phoned us up and told us SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 18 1 about the event. 2 Q. Okay. That makes all the sense in the 3 world. I understand. Now, have there been 4 any instances, to your knowledge, in which the 5 physician who reported an adverse event and 6 specifically an adverse event involving 7 aggression or suicidal thinking or behavior 8 believed in his or her mind that Paxil had a 9 causal role in that adverse event? 10 A. I would need to review all the 11 individual adverse events to answer that 12 question. I don't know the details of all the 13 adverse events that have gone into this 14 document. I rely on the staff within my 15 department to analyze them in detail. 16 Q. Okay. So, that's the kind of thing that 17 would really require some work on your part or 18 your company's part to decide and to advise us 19 whether or not that's the case? 20 A. Correct. 21 Q. All right. And that information may be 22 more appropriately obtained by an 23 interrogatory then your deposition. Have 24 there been -- what is your policy with respect 25 to making an internal determination of whether SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 19 1 Paxil played a causal role in the adverse 2 event that's being reported? 3 A. We review cases as they come in. We do 4 not, at that the stage, make any internal 5 assessments, except that it will prompt us to 6 do a review if we need to do a review. If the 7 case is such that it raises concerns within 8 the person who is reviewing, the physician who 9 reviews it, it may well prompt doing a review 10 of the issue. 11 Q. Okay. But there is no standard policy 12 which requires someone within SmithKline 13 Beecham to ascribe causality or noncausality 14 to the drug? 15 A. We don't make an individual causality 16 assessment as per some of the published rating 17 scales, causality assessments on individual 18 drugs as they come in -- on individual cases, 19 rather. 20 Q. Do you sometimes do that? 21 A. No. Our policy is to collect the data 22 and then analyze the data. As I say, if there 23 is a particular event that comes in of 24 concern, it may trigger a review of the issue, 25 but we don't do an individual causality SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 20 1 assessment, formal causality assessment on a 2 case-by-case basis for individual cases coming 3 in. 4 Q. To your knowledge, has there ever been 5 any instance in which an adverse event, which 6 involved aggression or suicidal thinking or 7 behavior was determined by someone inside of 8 SmithKline Beecham to be causally related to 9 Paxil? 10 A. Not to my knowledge. 11 Q. Is that situation something like the 12 clinician situation; that, to really answer 13 that question early, it would require, you 14 know, some determination by others under your 15 supervision? 16 A. Well, I've described to you our policy 17 of not making an individual assessment on a 18 case, but rather using a case to trigger a 19 review of the topic if it is of concern to 20 us. So, as far as I'm aware, and certainly 21 during my time in the Clinical Safety 22 Function, we would not have made an individual 23 causality assessment on any case. 24 Q. I see. Why not? 25 A. Because I don't believe that a single SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 21 1 case, particularly these complicated types of 2 cases here, can be used as a basis of a 3 causality assessment. You need to look at -- 4 you need to look at pooled data, data from 5 many sources, to evaluate whether there are 6 any associations or not. 7 Q. Well, we're going to have that 8 discussion in a few minutes, but explain to me 9 why if a reporting doctor, who had the 10 clinical encounter with a patient, reported to 11 your company, "Hey, I think Paxil caused this 12 man to be aggressive or suicidal.", explain to 13 me why you would not make your own internal 14 determination of whether he was right or 15 wrong? 16 A. We would review the reported event. We 17 would decide whether there are confounding 18 factors, but the sorts of events that we're 19 talking about here -- or perhaps I should ask 20 you to clarify which events we're talking 21 about here, actually. 22 Q. I'm talking about aggression and 23 suicidality. 24 A. Okay. For those events, these are all 25 multifactorial, complicated events that SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 22 1 commonly occur in the type of patients that 2 receive Paroxetine. It is not possible to 3 make causality assessments on the basis of 4 case reports such as the ones that we receive. 5 Q. Okay. Let's follow up on that. We all 6 know that there is a certain comorbidity 7 between depression and suicidality; right? 8 A. Correct. 9 Q. So, if someone is depressed and they're 10 getting Paxil, then one suspect for the 11 cause -- and they become suicidal, one suspect 12 for the cause of the suicidality is certainly 13 their depression; isn't it? 14 A. Correct. 15 Q. But you also know that it is a 16 multifactorial phenomenon; correct, sir? 17 A. Correct. There may be other factors 18 involved. 19 Q. One of those factors could be biological 20 in nature; couldn't it? 21 A. What do you mean by biological in 22 nature? 23 Q. I mean -- gosh, I mean something that 24 affected the chemical balance in the person's 25 brain. SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 23 1 A. We're speculating. I'm not sure that 2 I'm clear of what you're referring to. 3 Q. Dr. Hudson, are you aware of the body of 4 literature concerning the relationship between 5 serotonin and suicide? 6 A. In general. I've seen some summary 7 information on that. I've not reviewed that 8 information in detail. I would, again, 9 delegate that to people within my department 10 and also other psychiatrists within the 11 company who are more closely involved in 12 Paroxetine then I am, people such as 13 Dr. Wheadon. 14 Q. Let me just ask you this: Do you know 15 whether or not there is any association 16 between levels of serotonin or the serotonin 17 metabolite 5-HIAA and suicidal behavior? 18 A. Yes, I believe there is a correlation. 19 I have seen in the literature summary 20 information that implies that there is a 21 correlation between low levels of serotonin or 22 5-HIAA in patients' suicidal activity. 23 Q. Which one; serotonin or 5-HIAA? 24 A. I believe both have been implicated, but 25 I would repeat what I mentioned before: I SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 24 1 have not reviewed this literature in detail. 2 Q. Okay. So, given that, you understand 3 that suicide is not only a behavior 4 phenomenon, but is a biological phenomenon; 5 don't you? 6 A. It may be related to the 5-HIAA levels, 7 as we've discussed. 8 Q. And does Paxil lower or raise 5-HIAA 9 levels? 10 A. I think that question is best addressed 11 by pharmacology experts rather than myself. 12 I'm not an expert in pharmacology. 13 Q. Incidentally, is Paxil or Paroxetine 14 marketed under the name Paxil in the U.K.? 15 A. It's got a different name in the U.K. 16 Q. What is it? 17 A. Seroxat, I think. 18 Q. How many people are in your particular 19 organization? 20 A. Approximately 160. 21 Q. All right. How many instances are there 22 in which Paroxetine or Paxil has been reported 23 to SmithKline Beecham to be temporally 24 associated with acts of aggression or 25 suicidality? SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 25 1 A. Could you clarify what you mean by that; 2 temporally associated? I'm not sure what you 3 mean. 4 Q. I mean that a patient becomes homicidal 5 or suicidal within a relatively short period 6 of time from either taking Paxil or getting an 7 increase in dosage of Paxil? 8 A. You haven't defined what you mean by 9 relatively short period of time, but I would 10 also have to go back and -- I don't know the 11 answer to that question. I would need to go 12 back and discuss that with people within my 13 department in terms of short period of time, 14 but you would need to define what you meant by 15 that. 16 Q. Okay. Let's say within the first thirty 17 days. 18 A. I would need to review the data we have 19 to be able to answer that accurately. 20 Q. Okay. Do you know what a psychological 21 autopsy is? 22 A. I have seen reference to it in some of 23 the literature, but I've not seen it defined. 24 Q. Okay. And this is a very layman's 25 description, but basically it's an effort SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 26 1 after the death of a person to go back and get 2 all the information you can about what might 3 or might not have affected their behavior, 4 particularly in a suicide state, what might or 5 might not have contributed to cause suicide. 6 Can you tell me whether or not SmithKline 7 Beecham has ever made any systematic effort to 8 conduct that type of inquiry or investigation 9 into the circumstances surrounding the death 10 of people who have committed suicide or 11 murder/suicide while under the influence of 12 Paxil? 13 A. I can tell you our policy. Our policy 14 is to follow up with reporters of events, to 15 identify relevant information that may have 16 been involved in that event, so -- and we 17 certainly do that because we want to have an 18 understanding of that event, understand the 19 nature of it, whether there are any other 20 circumstances, compounding factors, et cetera. 21 Q. Well, let's be very clear about this. 22 You've already told me that your policy does 23 not involve anyone within SmithKline Beecham 24 making a determination of whether Paxil played 25 any role in the death or violent behavior of SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 27 1 that person; right? 2 A. I told you that we didn't do an 3 individual case causality assessment. 4 Q. Okay. Which is basically what I just 5 said; that you guys do not try internally, 6 when this is reported, to say, "Was our drug 7 involved or not"; do you? 8 A. No. What I said is: We don't do an 9 individual case causality assessment. I did 10 say to you: We review individual cases and it 11 may trigger a review of the topic if there are 12 events that come in of concern. 13 Q. We may be miscommunicating. If 14 Mr. Jones, in the State of Kansas, you know, 15 commits a murder and then suicide and his 16 doctor reports it to SmithKline Beecham and 17 says, "Hey, I think this drug may have caused 18 it." Does SmithKline Beecham make an 19 investigation into the circumstances of 20 Mr. Jones? 21 A. What SmithKline Beecham will do is go 22 back to the person who reports the case to ask 23 them more information in relation to -- I 24 mean, this may all come in at the first 25 report, but if it doesn't, we would follow up SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 28 1 through the reporter of the case, if it's a 2 health care professional, to inquire about 3 further information, to ask about whether 4 there is any medical history, relevant medical 5 history or other drugs involved. So, we would 6 follow up on individual cases to identify 7 whether there are other factors involved. 8 Q. You keep saying to try to identify if 9 there are other factors or compounding 10 factors. And what that suggests to me, with 11 all due respect, sir, is that you're looking 12 for other things to blame other than Paxil. 13 MR. PREUSS: Objection; 14 argumentative. 15 BY MR. VICKERY: 16 Q. My question to you, Dr. Hudson, is: Do 17 you try to determine, internally, whether and 18 to what extent Paxil jointly, with all of the 19 other factors that may or may not be involved, 20 to what extent Paxil may or may not have 21 played a role in Mr. Jones' behavior in the 22 question that I posed to you? 23 A. I don't believe you can make a causality 24 assessment based on individual case reports. 25 We certainly do look at cases that come in to SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 29 1 understand them, understand them from a 2 medical point of view and see if there's an 3 issue or a signal has arisen from a number of 4 cases that come in. If that were the case, we 5 would certainly go ahead and analyze the data, 6 the complete set of data, to evaluate whether 7 there was any association or issue or not. 8 Q. So, in the hypothet that I gave you of 9 Mr. Jones who committed these acts and whose 10 physicians believe the Paxil may have been a 11 contributing factor, is it true, sir, that 12 SmithKline Beecham would never try to decide, 13 one way or the other, whether Paxil 14 contributed to that particular individual's 15 behavior; is that true? 16 A. We would follow up that case, as I've 17 described to you. We would then make a 18 determination on the basis of the information 19 we had whether any further investigation in 20 terms of this whole issue was required. If we 21 felt that there was a need to investigate an 22 issue further, we would do an analyses of the 23 issue pooling in information from a variety of 24 different sources and then we would be in a 25 much fuller position to be able to answer the SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 30 1 question. 2 Q. Dr. Hudson, I don't want to mince words 3 with you -- I'm sorry. My clock is clinging 4 here -- but is it true, sir, that you would 5 not try to determine, on an individual basis, 6 whether Paxil contributed to our mythical 7 Mr. Jones' behavior; is that true or not? 8 A. We would evaluate the case to determine 9 whether other factors were involved or whether 10 this particular case raised a signal. If it 11 did, we would evaluate it further. But as 12 I've said before, it's extremely -- it would 13 be impossible to determine, on an individual 14 case basis, any causality relationship, but we 15 would certainly take all cases reported to us 16 seriously and we would evaluate them 17 appropriately and follow up as necessary. 18 Q. Okay. So, your view is: It's simply 19 impossible for SmithKline Beecham to decide 20 whether Paxil did or did not contribute to the 21 homicidal or suicidal behavior of any one 22 given individual; is that your testimony? 23 A. We would certainly gather all the 24 information, but on an individual case basis 25 it would be impossible to decide whether SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 31 1 Paroxetine caused an event or not. 2 Q. Okay. Now -- hold on just a minute. I 3 want to -- if you were to get Exhibit Two 4 there, the Aggression Study -- I've lost my 5 page. Bear with me just a second. Okay. 6 Would you turn to page twenty-one of 7 sixty-three? Are you there with me? 8 A. Yes. 9 Q. Now, is it impossible for SmithKline 10 Beecham to determine whether the patient 11 identified in the fifth report on the bottom 12 of that page, whether his behavior was caused 13 or was not caused by Paxil? 14 A. On an individual case basis, it would be 15 impossible to say whether a drug caused an 16 event. 17 Q. Okay. Do you know if that patient, 18 that's reflected down there, is the decedent 19 of my client? Is that Donald Shell? 20 A. I believe it is, yes. 21 Q. You're telling me, under oath, it's 22 simply impossible for SmithKline Beecham to 23 decide whether Paxil did or did not cause 24 Mr. Shell to murder his wife, his daughter, 25 his granddaughter and then to commit suicide; SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 32 1 is that right, sir? 2 A. It is impossible, on an individual case 3 basis, from individual reports, to assign 4 causality especially in a very complicated 5 area such as this. That's why, when we have 6 issues, we review all the available data and 7 make a determination, on the basis of all the 8 available data, whether there is an issue or 9 not. 10 Q. Okay. Do you believe that it is 11 possible that Paxil has caused any person, 12 worldwide, to commit an act of homicide or 13 suicide? 14 MR. PREUSS: Object to form. 15 THE WITNESS: I have seen no 16 evidence to suggest that at all. 17 BY MR. VICKERY: 18 Q. But from what you're telling me, in any 19 individual case, it's just -- your company's 20 view is it's impossible to know; right? 21 A. I'm saying that on the basis of 22 individual reports, we may review the data in 23 detail, once we review the data in detail 24 we'll see if there are any issues, whether 25 there is any association. And I'm telling you SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 33 1 that my conclusions are that I have seen no 2 data at all to suggest that on an individual 3 case basis there is any casual association 4 between Paroxetine and an event. 5 Q. Does your adverse event report include 6 specific boxes for the people making the 7 report to say whether or not whatever adverse 8 event was happening abated when the drug was 9 removed or whether it reappeared when the 10 person was rechallenged with the drug? 11 A. We would record that information in the 12 narrative. 13 Q. Why? 14 A. Sorry? Did you say "why" or "fine"? I 15 didn't -- 16 Q. I said "why". 17 A. Why? Because, as I've described, we try 18 to characterize the cases as fully as 19 possible. 20 Q. Well, if a person has an adverse event 21 and that adverse event goes away when the drug 22 is removed, is that suggestive to you that the 23 drug may be causing the adverse event? 24 A. No, not necessarily. 25 Q. I didn't say "necessarily". SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 34 1 A. No. 2 Q. I chose my words very carefully. 3 A. Okay. 4 Q. Does it suggest to you that the drug 5 might be causing that event? 6 A. No. There are many other factors 7 involved. 8 Q. Okay. What if the person were then 9 rechallenged with the drug and the adverse 10 event reappeared; would that suggest to you 11 that the drug may cause that? 12 A. No. Again, there are many other factors 13 involved. 14 Q. Okay. How do we ever prove or disprove 15 whether a drug causes any adverse event? How 16 do you do that? 17 A. There are a number of ways of doing 18 that. Formal randomized studies with well 19 matched populations looking for statistical 20 significance would be one way. Metroanalyses 21 across programs -- across studies would be 22 another. 23 Q. Let's talk about the first one you've 24 chosen, randomized clinical trial; okay? 25 A. Right. SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 35 1 Q. Do you believe, sir, that Paxil has a 2 beneficial effect on suicidal thinking for a 3 patient? 4 A. Yes, the data I have seen suggest that 5 that is the case. 6 Q. All right. So that if there were, let's 7 just say, hypothetically, a group of a hundred 8 patients and they were all depressed and they 9 were all thinking about suicide -- no, I'm 10 sorry. Let me rephrase it. If there's a 11 group of a hundred patients and they were all 12 depressed, but twenty of them were, you know, 13 actively thinking about suicide, is it your 14 belief that if you gave Paxil to all of those 15 hundred people, that some of the twenty would 16 have a lessening of their suicidal thoughts? 17 A. The clinical trial data shows that 18 patients who receive Paroxetine are likely to 19 see an improvement in any suicidal ideation. 20 Q. Right. So you would expect that some of 21 the twenty would get better; right? 22 A. Right. 23 Q. Now, what if five of the twenty got 24 better, but one person from the eighty that 25 were never even thinking about suicide SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 36 1 actually became suicidal and committed 2 suicide; would a statistical analysis reflect 3 that that person, the experience of that 4 person? 5 MR. PREUSS: Object to form. 6 THE WITNESS: I'm not sure 7 what the statistic -- I'm not a statistician. 8 I can't talk about a statistical analysis. 9 I'm not clear about the question you're 10 asking. 11 BY MR. VICKERY: 12 Q. What I'm really asking is this: If it's 13 true that this drug helps suicidal thinking, 14 which, quite frankly, I think is true in some 15 people, but if it is also true that in a 16 smaller number of people it precipitates 17 suicidal acts, then that smaller number gets 18 mapped in the figures of the other ones; don't 19 they? 20 MR. PREUSS: Object to form; 21 assuming facts not in evidence. 22 BY MR. VICKERY: 23 Q. You may answer my question. 24 A. I'm not aware of any data that suggests 25 that patients will be precip -- I think your SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 37 1 word was "precipitated". I'm not aware of any 2 data that suggests any patients will be 3 precipitated into suicidal ideation. Quite 4 the contrary. The analyses that we have done, 5 where we have taken patients without any 6 suicidal ideation at baseline, using the HAMD 7 score, this is a metroanalyses of cross 8 trials, have showed no increase in suicidal 9 ideation in these patients compared to 10 placebo. And, indeed, the other way around, 11 there's a statistically significant 12 improvement for those patients who had HAMD of 13 zero. 14 Q. Dr. Hudson, you're quibbling with my 15 hypo. The question is: Whether or not the 16 experience of that one person would show up in 17 the data? That's the real question. Would it 18 show up in the data or would it be hidden by 19 the beneficial effects on the other patients? 20 A. I'm not sure I really understand the 21 question you're asking. I mean, certainly we 22 would report all the data from the trial, so 23 there would be no question of the information 24 not being available. 25 Q. Okay. Well, if you're not sure you SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 38 1 understand it, let me go on to something 2 else. Do you know of any reason why 3 SmithKline Beecham could not do psychological 4 autopsies? I'm not talking about just, kind 5 of, gathering the information about other 6 things you could blame, but I'm talking about 7 complete psychological autopsies on patients 8 who his physician or others have reported 9 their suicidal or aggressive behavior in 10 temporal association with Paxil. Is there any 11 reason why you could not do psychological 12 autopsies on those patients? 13 MR. PREUSS: Well, I object to 14 the form. I think that's mischaracterizing 15 his testimony as to what he's done when cases 16 are reported. 17 BY MR. VICKERY: 18 Q. You may answer my questions, sir. 19 A. I've described to you what we do. We do 20 go back to the reporter to inquire about 21 further information to insure that we do 22 gather information, other relevant information 23 about the case. 24 Q. But what you've told me in about four 25 different answers is: You're looking for SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 39 1 other factors that could be involved, 2 compounding factors, but that you never seek 3 to determine whether Paxil contributed to it. 4 And my only question is: Could you do so, if 5 you wanted to? 6 A. Well, we do evaluate a case. I mean, 7 I'm describing to you what my previous answer 8 is, but we do evaluate cases to identify if 9 there are other factors involved or whether we 10 need to investigate the subject further. So, 11 we certainly do go back to the reporter, who's 12 a health care professional, and ask relevant 13 questions. 14 Q. Okay. Let me follow up on that. If you 15 find that there are other factors involved, do 16 you then say "Well, we don't need to 17 investigate further." 18 A. Well, we continue to review all topics 19 on a regular basis. We write six monthly 20 periodic safety update reports on all 21 compounds, including Paroxetine. So, we do, 22 on a regular basis, review all the data coming 23 in and decide whether any further action is 24 required. 25 Q. Okay. Let me change gears on you a SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 40 1 minute. Do you all report the adverse event 2 information in terms of patient years? 3 A. Sorry. Could rephrase the question? 4 Q. Is your reporting kept in terms of 5 patient years? When you -- in other words, 6 when you report the incident or rate of 7 adverse events, do you report it in patient 8 year terms? 9 A. Which safety information are you 10 referring to? 11 Q. Adverse events associated with Paxil. 12 A. But from what source? 13 Q. From any source. 14 A. Well, some is presented based on just 15 the figures that come in, some -- I think 16 clinical trial -- sometimes clinical trial 17 data is presented in terms of patient event 18 years -- no -- patient exposure years. Sorry. 19 Q. Now, if there is an adverse event and 20 that adverse event typically occurs very early 21 on and the reporting of the company is done in 22 terms of overall patient years, does that 23 accurately demonstrate the adverse event? 24 A. I don't think I understand your 25 question. I don't understand what you mean by SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 41 1 "early on". 2 Q. Well, maybe an example would help. A 3 lot of people do real well on Paxil and they 4 stay on it a long time; don't they? 5 A. Some patients stay on it a long time, 6 but I don't have detailed information on how 7 long people stay on it. 8 Q. If there were only two patients in our 9 group and one stayed on it for two years, but 10 the other had very serious adverse events and 11 dropped out within the first two weeks, how 12 does that get reported when you record the 13 information in terms of patient years? 14 A. Well, my group typically does not 15 present the information in terms of patient 16 years. I've certainly seen, in the past, some 17 information from the clinical trials presented 18 both ways. It's presented both in terms of 19 absolute numbers and also in terms of patient 20 years. So, the information is there for the 21 reviewer to see. 22 Q. Okay. Dr. Hudson, does Paxil have an 23 association with akathisia? 24 A. I've seen some case reports of 25 akathisia. I'm aware that there have been SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 42 1 some cases of akathisia, so it is something 2 that we have received case reports about. 3 Q. Do you believe, as Worldwide Safety 4 Director of SmithKline Beecham, that Paxil 5 causes some patients to become akathisic? 6 A. I've seen no evidence to suggest a cause 7 and affect relationship between Paroxetine and 8 akathisia. I've seen some case reports, but 9 I've seen nothing that suggests a cause and 10 affect relationship. 11 Q. Has SmithKline Beecham ever funded 12 either a large scale clinical trial or an 13 epidemiological trial to prove one way or the 14 other whether there is a cause and affect 15 relationship between Paxil and akathisia? 16 A. Well, SmithKline Beecham has conducted 17 many studies on Paroxetine that will include a 18 gathering of safety information, and so safety 19 information relevant to that may have been 20 included in those. 21 Q. Dr. Hudson, do you know what a primary 22 outcome measure is? 23 A. Could you define it for me? 24 Q. Sure. The principal main thing that 25 you're trying to decide when you conduct a SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 43 1 study. 2 A. Right. 3 Q. Hypothesis. You know what that is; 4 don't you? 5 A. Primary hypothesis. 6 Q. Has SmithKline Beecham ever conducted a 7 study, either a randomized clinical trial or a 8 large scale epidemiological trial, where the 9 principal hypothesis being studied was: This 10 drug either caused it or does not cause 11 akathisia? 12 A. I'm not aware of any such study, but, 13 again, all the studies that have been 14 conducted in all the ways that we gather the 15 safety information, will gather information on 16 cases akathisia, if they are reported. So, we 17 will gather that information through a variety 18 of other sources. 19 Q. Has SmithKline Beecham ever conducted a 20 large scale clinical study or epidemiological 21 study where the principal hypothesis being 22 tested was: This drug either causes or does 23 not cause suicide? 24 A. We have looked at suicide through a 25 number of different tools that are available SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 44 1 to us to identify -- to address that question. 2 Q. But have you conducted a large scale 3 study where the principal hypothesis being 4 tested where the drug caused it or does not 5 cause suicide? 6 A. Again, we have evaluated this through a 7 number of different tools. If you're asking 8 whether we've conducted a randomized 9 prospective study, that is an inappropriate 10 way to study the issue. We believe we've 11 studied this issue in an entirely appropriate 12 way. 13 Q. Have you ever done a rechallenge test? 14 A. For what? 15 Q. A rechallenge study to look into the 16 issue of whether Paxil causes or does not 17 cause suicide? 18 A. I think there would be considerable 19 ethical issues there. All the data that's 20 available that we have seen suggests that 21 Paxil reduces suicidal ideation, not the other 22 way around. So, I think there would be 23 considerable ethical concerns here. 24 Q. Are you aware of the fact that Eli Lilly 25 & Company designed such a rechallenge study SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 45 1 and actually submitted the protocol to the 2 FDA? Are you aware of that? 3 A. No, I've not seen that. I've not seen 4 that study. 5 Q. All right. Are you aware of the fact 6 that one of the people that assisted in the 7 design of that study was Dr. Wheadon, who is 8 now at SmithKline Beecham? 9 A. No, I wasn't aware of that. 10 Q. Has SmithKline Beecham ever tried, in a 11 systematic way, to look into the modality of 12 deaths of people who commit suicide while on 13 Paxil? 14 A. The reviews of suicide that have been 15 done on Paxil have evaluated the mode of 16 death; that's correct. 17 Q. Is it true, sir, that most of the people 18 who have committed suicide, while taking 19 Paxil, have done so in a violent way? 20 A. No, I'm not aware of data showing that. 21 I would need to go back and have a look to 22 answer that question. 23 Q. Okay. Are you familiar with a concept 24 in epidemiological studies dealing with the 25 power of the study to measure or determine SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 46 1 whatever it is the study is looking for? 2 A. Yes. 3 Q. Kindly explain that in laymen's terms 4 for us. What does power mean when you're 5 talking about an epidemiological study? 6 A. Can you define -- well, my understanding 7 of power refers more to randomized clinical 8 studies. 9 Q. Okay. Tell me, then, what is your 10 understanding of it in that context? 11 A. The ability of the study to confirm or 12 reject the hypothesis. 13 Q. If the hypothesis is one that involved a 14 rare effect, whether it's beneficial or 15 adverse, does it take a lot more people to 16 have sufficient power to prove or disprove the 17 relationship of the drug to that effect? 18 A. I would need to see the specific example 19 you're talking about and the difference that 20 you're expecting to see. 21 Q. Just as a general proposition, if you're 22 looking for something that only happened, say, 23 in three to five percent of the population, 24 you would have to have a whole bunch of people 25 to prove that the drug caused or didn't cause SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 47 1 that event; wouldn't you? 2 A. You may have to go to other tools, like 3 studying a metroanalyses of cross studies, 4 that sort of thing. It may be an impossible 5 question to answer by a simple randomized 6 study, so you may have to use other tools. 7 Q. Okay. Let's go back to Exhibit Two for 8 a minute, the Aggression Study. Prior to that 9 study being done, did you have any 10 understanding of the phenomenon described 11 there called neurolytic induced akathisia? 12 A. I've seen reference to it in the 13 literature. I have not studied it in detail. 14 Q. Okay. Do you know whether or not the 15 diagnosis of neurolytic induced akathisia, 16 under the DSM-4, requires proof of both 17 objective manifestations of motor movements as 18 well as a subjective feeling of inner 19 restlessness? 20 A. I would need to check the definition in 21 DSM-4 to answer your question. I can't recall 22 the exact wording, but I do recall there are 23 elements of subjective and objective 24 restlessness, but exactly the wording, I can't 25 recall. SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 48 1 Q. Dr. Hudson, in the materials that were 2 provided to me, one of the articles that you 3 read was an article by Dr. Lane called 4 SSRI-Induced Extrapyramidal Symptoms and 5 Akathisia. Do you recall that article? 6 A. Yes. I would like to review it again if 7 you would like to ask me detailed questions on 8 it. 9 MR. VICKERY: Mr. Anderson, do 10 you have that article there? 11 MR. ANDERSON: I'm not sure I 12 do; I'll check. Why don't we take a break. 13 MR. VICKERY: Okay. Let's all 14 take a five minute break and go to the men's 15 room or whatever and you can see if you can 16 locate that one. 17 MR. PREUSS: Okay. I'm going 18 to put you on mute and I'll come back on in 19 about five minutes. 20 MR. VICKERY: Okay. 21 MR. PREUSS: Thank you. 22 THE VIDEOTAPE OPERATOR: Going 23 off the video record. The time is 10:32. 24 - - - 25 (Exhibit Hudson-3 was marked SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 49 1 for identification and received into evidence 2 and is attached hereto.) 3 - - - 4 THE VIDEOTAPE OPERATOR: Back 5 on the video record. The time is 10:44. 6 BY MR. VICKERY: 7 Q. Dr. Hudson, over the break were you able 8 to locate the Lane article? 9 A. Yes, I've got a copy in front of me. 10 Q. Is that an article that you read in 11 preparation for this deposition today? 12 A. I've looked through it briefly in the 13 past, yes. 14 Q. Was it chosen by you or selected by 15 someone else for you to read? 16 A. It was sent to me by Counsel. 17 Q. All right. And do you see that the 18 author of the article, Dr. Lane, is an 19 employee of Pfizer? 20 A. Yes, I do. 21 Q. Pfizer's interests with regard to the 22 question of SSRI-induced suicidality or 23 violence, are certainly the same as your 24 company; don't you think? 25 A. Sorry. Could you rephrase that SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 50 1 question? 2 Q. Yes. Pfizer has the same interest, with 3 respect to this question, of whether SSRI 4 drugs, as a class, caused violence or suicide 5 as your company has; don't you think? 6 MR. PREUSS: Object to form. 7 BY MR. VICKERY: 8 Q. You can answer. 9 A. I can't talk for Pfizer. 10 Q. Well, don't you know that all of the 11 SSRI drug manufacturers are interested in -- 12 is not disproving that these drugs cause 13 violence or suicide, at least keeping people 14 from proving that? 15 MR. PREUSS: Well, object to 16 the form. 17 BY MR. VICKERY: 18 Q. You can answer my question, Doctor. 19 A. I can't speak for any other company. 20 All I can talk about is our approach, which is 21 to evaluate data that comes in in an open and 22 fair manner to decide what we believe it shows 23 us. 24 Q. Okay. In the materials that were 25 provided to me, there was also an abstract of SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 51 1 a recent article by Dr. David Healy. Do you 2 know Dr. Healy, either personally or by 3 reputation? 4 A. I don't know him personally. I've heard 5 of Dr. Healy. 6 Q. In what context have you heard of him? 7 A. I've seen a manuscript that he has 8 written, which is being forwarded to me. 9 Q. You mean things that were actually 10 published or manuscripts -- 11 A. No. 12 Q. -- that were under review? 13 A. No, no, no. Published material. And 14 I've seen his name, also, in media reports as 15 well. 16 Q. So, have you made a systematic effort to 17 read his manuscripts or just read them 18 whenever they happen to come across your desk? 19 A. I've read manuscripts that have been 20 given to me for the purpose of preparation for 21 this deposition. 22 Q. Have you ever read any expert witness 23 report or deposition of Dr. Healy? 24 A. I have seen a document, I'm not quite 25 sure of the nature of the document, that SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 52 1 describes his position on SSRIs. I'm not sure 2 I know exactly the nature of it. It may have 3 been a statement. 4 Q. Okay. Well, Doctor, let me ask you 5 this: I assume that if we go to trial in this 6 case in Wyoming, or in any other case in the 7 United States, if SmithKline Beecham asked you 8 to come and testify live, you will do so; 9 won't you? 10 A. Well, SmithKline Beecham will have to 11 decide who its most appropriate witnesses are 12 to be. I will be leaving the company at the 13 end of the year because I'm taking up another 14 appointment at the Medicines Control Agency in 15 the U.K. 16 Q. Oh, okay. But not until -- well, just 17 at the end of this year? 18 A. Correct. 19 Q. I see. Incidentally, is SmithKline 20 going to implement the new suicide warning 21 that the Medicines Control Agency in the U.K. 22 recommended back in August of this year? 23 A. Could you refer to -- tell me exactly 24 what the warning is? 25 Q. The warning concerning suicide, suicide SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 53 1 and Paxil. Have you seen it? 2 A. Well, SmithKline Beecham and the MCA 3 have been in discussion in relation to -- 4 including some wording within the U.K. data 5 sheet. Exactly what the final wording will 6 be, I don't know, I have not seen it. I would 7 have to consult my colleagues on that. 8 Q. But is SmithKline Beecham going to 9 implement a wording change with respect to the 10 issue of suicide on the Paxil label some time 11 in the near future? 12 A. We've certainly been in discussions with 13 the MCA about that. I'm not sure whether 14 that's finally resolved and when that's going 15 to happen. 16 Q. Did you know that the MCA recommended 17 that there be a wording change? 18 A. I'm aware that last year the MCA wrote 19 to SmithKline Beecham asking the company to 20 include a comment in relation to suicide, that 21 the risk doesn't disappear on the start of 22 treatment. I would need to go back to the 23 files to see exactly what the wording was. 24 Q. Okay. What will be your position at 25 MCA? SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 54 1 A. I'll be Director of the Licensing 2 Division at the Medicines Agency -- Medicines 3 Control Agency. 4 Q. What will be the general nature of your 5 functional responsibilities there? 6 A. The Medicines Control Agency has a 7 Licensing Division and a Post-Licensing 8 Division and a number of other divisions such 9 as enforcement, finance, et cetera. The 10 Licensing Division is responsible for the 11 technical license -- technical review of 12 license applications. So, we'll be working 13 with the committee on Safety of Medicines and 14 the European Medicines Evaluation Agency doing 15 technical assessments on new applications, 16 clinical trial approvals, things like that. 17 Q. Is the Licensing Division responsible 18 for the verbiage, whether warnings or other 19 verbiage on the label for Paroxetine in the 20 U.K.? 21 A. The Post-Licensing Division will deal 22 with marketed drugs. The Licensing Division 23 will deal with things up to first approval. 24 Q. Okay. But you will not have any role at 25 the Licensing Division with respect to any SPHERION DEPOSITION SERVICES (713) 650-3500 IAN R. B. HUDSON, M.R.C.P., M.D. 55 1 warning that is or is not implicated on 2 Paroxetine's label in the U.K.; is that 3 correct? 4 A. That is correct. 5 Q. Okay, sir. 6 MR. VICKERY: I will pass the 7 Witness, gentlemen. 8 MR. PREUSS: No questions. 9 THE VIDEOTAPE OPERATOR: Going 10 off the video record. The time is 10:51. 11 This concludes today's videotape deposition. 12 13 14 15 16 17 18 19 20 21 22 23 24 25 SPHERION DEPOSITION SERVICES (713) 650-3500 56 1 C E R T I F I C A T E 2 - - - 3 STATE OF NEW JERSEY : 4 : S.S.: 5 COUNTY OF BURLINGTON : 6 - - - 7 8 I, Lorraine M. Edwards, Court 9 Reporter and Notary Public within and for the 10 County of Burlington, State of New Jersey, do 11 hereby certify that the foregoing testimony of 12 IAN R. B. HUDSON, M.R.C.P., M.D. was taken 13 before me at 2005 Market Street, 36th Floor, 14 Philadelphia, Pennsylvania, 19103, on Friday, 15 December 15, 2000; that the foregoing 16 testimony was taken by me in shorthand by 17 myself and reduced to typing under my 18 direction and control; that the foregoing 19 pages 1 through 55 contain a true and correct 20 transcription of all of the testimony of said 21 Witness. 22 23 ......................... LORRAINE M. EDWARDS 24 Notary Public 25 My Commission expires July 31, 2002 SPHERION DEPOSITION SERVICES (713) 650-3500 57 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. SPHERION DEPOSITION SERVICES (713) 650-3500 58 1 ERRATA SHEET 2 PAGE LINE # CHANGE REASON THEREFORE 3 ________________________________________________ 4 ________________________________________________ 5 ________________________________________________ 6 ________________________________________________ 7 ________________________________________________ 8 ________________________________________________ 9 ________________________________________________ 10 ________________________________________________ 11 ________________________________________________ 12 ________________________________________________ 13 ________________________________________________ 14 ________________________________________________ 15 ________________________________________________ 16 ________________________________________________ 17 ________________________________________________ 18 ________________________________________________ 19 ________________________________________________ 20 ________________________________________________ 21 ________________________________________________ 22 ________________________________________________ 23 ________________________________________________ 24 ________________________________________________ 25 ________________________________________________ SPHERION DEPOSITION SERVICES (713) 650-3500 59 1 I have read the foregoing 2 deposition and the answers given by me are 3 true and correct, to the best of my knowledge 4 and belief. 5 6 7 8 ................................ 9 IAN R. B. HUDSON, M.R.C.P., M.D. 10 11 ....................... Witness to signature 12 ....................... 13 Address 14 My Commission expires 15 ..................... 16 17 18 19 20 21 22 23 24 25 SPHERION DEPOSITION SERVICES (713) 650-3500