charles schulz deposition part two 2008

7/30/2019 Charles Schulz Deposition Part Two 2008

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1 STATE OF MINNESOTA DISTRICT court

2 COUNTY OF HENNEPIN FOURTH JUDICIAL DISTRICTWrongful Death3

- - - - - - - - - - - - - - - - - - - - - - - - - -4 Court File No.

Mary Weiss, on her own behalf 27CV07-16795 and as next of kin and trustee

of the Estate of Dan Markingson,6 deceased,

7 Plaintiff, VideotapeDeposition

8 -vs- (Vol. 2)

9 Board of Regents for the University ofMinnesota; Dr. Stephen Olson;

10 Dr. Charles Schulz; InstitutionalReview Board for the University of Minnesota;

11 Astrazeneca Pharmaceuticals, LP;Astrazeneca LP and Zeneca, Inc.,

12Defendants/Respondent

13 - - - - - - - - - - - - - - -Volume 2, pgs. 265 - 338

14 Deposition of: CHARLES SCHULZ, M.D.

15 Taken at: Pearson, Randall &Schumacher

16 100 South Fifth StreetSuite 1025

17 Minneapolis, Minnesota

18 Date: January 18, 2008

19 Commencing at: 8:30 a.m.

20

21

22

23 By MARTHA M. FIER, court REPORTER

24 12151 Gantry Lane


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Apple Valley, Minnesota 5512425 800-844-6420 * 952-431-1252

266

1 Deposition of CHARLES SCHULZ, M.D., taken

pursuant to Notice to Take Oral Deposition, under the2 Rules of Civil Procedure, for the District Courts of

Minnesota, at Pearson, Randall & Schumacher, 1003 South Fifth Street, Suite 1025, Minneapolis,

Minnesota, commencing at approximately 8:30 a.m., on4 the 18th day of January, 2008, before Martha M. Fier,

Notary Public, in and for the State of Minnesota.5

- * -6

APPEARANCES:

7R. CHRIS BARDEN, Esq., and GALE D. PEARSON,

8 Esq., of the law firm of Pearson, Randall &Schumacher, Fifth Street Towers, 100 South Fifth

9 Street, Suite 1025, Minneapolis, Minnesota 55402appeared for and on behalf of Plaintiff.

10DAVID P. ALSOP, Esq., and ANGELA M. NELSON,

11 Esq., of the law firm of Gislason & Hunter, 701 XeniaAvenue South, Suite 500, Minneapolis, Minnesota 55416

12 appeared for and on behalf of Defendants Olson andSchulz.

13DAVID C. HUTCHINSON, Esq., and CHARLES A.

14 GROSS, Esq., of the law firm of Geraghty, O'Loughlin& Kenney, Alliance Bank Center, 55 East Fifth Street,

15 Suite 1100, St. Paul, Minnesota 55102 appeared forand on behalf of Defendant Board of Regents of the

16 University of Minnesota.

17 BRIDGET M. AHMANN, Esq., of the law firm ofFaegre & Benson, 2200 Wells Fargo Center, 90 South

18 Seventh Street, Minneapolis, Minnesota 55402-3901

appeared for and on behalf of Defendants Astrazeneca19 and Zeneca.

20 Also present, Ruth Flynn, Esq., RiskManagement Operations Director, University of

21 Minnesota Physicians, Suite 200, 720 Washington,Avenue SE, Minneapolis, Minnesota 55414.

22- * -

23Examination:


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24 By Dr. Barden ........... 268

25 Exhibits: V - Amended Videotape DepositionNotice marked on page 324

267

1 VIDEOGRAPHER: We are now on the

2 video record. This is the continuing deposition of

3 Dr. Charles Schulz being recorded Friday, January 18,

4 2008 in Minneapolis, Minnesota. At this time, will

5 the attorneys please identify themselves for the

6 record.

7 DR. BARDEN: My name is Dr. Chris

8 Barden, and I'm here for Mary Weiss.

9 MS. PEARSON: My name is Gale Pearson

10 on behalf of Plaintiff Mary Weiss.

11 MS. AHMANN: Bridget Ahmann on behalf

12 of Defendant Astrazeneca.

13 MR. GROSS: Charles Gross on behalf

14 of the University of Minnesota.

15 MR. HUTCHINSON: David Hutchinson for

16 the University of Minnesota.

17 MS. NELSON: Angela Nelson for Dr.

18 Schulz.

19 MR. ALSOP: David Alsop on behalf of

20 Dr. Schulz.

21 VIDEOGRAPHER: The time is now 8:38

22 a.m. Will the court reporter please administer the


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23 oath.

24

25

268

1 CHARLES SCHULZ, M.D.

2 called as a witness,

3 having been duly sworn,

4 was examined and testified as follows:

5 EXAMINATION

6 BY DR. BARDEN:

7 Q. Okay. Good morning, Dr. Schulz.

8 A. Good morning, Dr. Barden.

9 Q. Since the last time we've spoken, have you

10 done anything to prepare for the continuing

11 deposition?

12 A. I've had a meeting with counsel, Mr. Alsop

13 and Ms. Flynn, and I've reviewed my deposition.

14 Q. Okay. The same rules apply as in the

15 previous day. That is, I'll never ask you for any

16 names of your other clients, I'll never ask you for

17 any conversations you've had with your lawyers. Fair

18 enough?

19 A. That sounds fair.

20 Q. If you need a break, just ask. That will

21 be fine. And if you ever have any questions about

22 what I'm asking you, if it's not clear, just ask me


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23 and I'll try to rephrase it. Does that sound fair?

24 A. Yes.

25 Q. Okay. Have you hired your own lawyer?

269

1 A. No.

2 Q. Okay. Do you know who the expert witnesses

3 are who have been listed as part of your defense?

4 MR. ALSOP: What do you mean? Know

5 their names or -- it's vague. Go ahead. You can

6 answer.

7 THE WITNESS: Okay. I met with

8 Mr. Alsop and I've talked with him on the phone, and

9 I --

10 MR. ALSOP: Well, don't tell him

11 about discussions with me.

12 THE WITNESS: Pardon me. I'm aware

13 that there are three experts: A Dr. Jan Fawcett, a

14 Dr. Ira Glick and a Dr. David Dunner.

15 BY DR. BARDEN:

16 Q. Okay. And you mentioned that you have

17 spoken to them by phone?

18 A. No. I've had no contact with these three

19 people.

20 Q. Okay. Do you know any of them?

21 A. Yes, I do.


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22 Q. And what is your relationship with Dr.

23 Fawcett?

24 A. I met Dr. Fawcett probably during the 1980s

25 at scientific meetings. He was doing some research

270

1 work related to depression that I was very interested

2 in, so I would talk with him in the corners after

3 presentations, et cetera.

4 Q. You've had no conversations with Dr.

5 Fawcett related to this case whatsoever, correct?

6 A. Correct.

7 Q. Dr. Glick.

8 A. Uh-huh.

9 Q. Have you ever known Dr. Glick?

10 A. Yes, I have. Dr. Glick also I have met at

11 scientific meetings over the years. I can't remember

12 exactly the first time I met him, but I would

13 estimate at least 20 years I've known Dr. Glick.

14 He's published extensively in our field and I've

15 talked with him on occasion regarding scientific

16 projects or scientific ideas.

17 Q. Okay. And the third one was Dr. --

18 A. David Dunner.

19 Q. Uh-huh. And do you know Dr. Dunner?

20 A. Yes, I do, in essentially the same

21 capacity. I've known Dr. Dunner for about 25 years,


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22 an estimate, and again, meeting with him at

23 scientific meetings and talking with him about

24 research, et cetera.

25 Q. Okay. Have you ever done any research with

271

1 any of these three?

2 A. I have done some research with Dr. Ira

3 Glick about, I would say, 20 years ago. He was

4 working -- I can't remember where, but he was part of

5 a group called The Treatment Strategies Study for

6 Schizophrenia, and I worked with him on that project

7 a little. I wasn't an author or co-investigator, but

8 we were working on a study together in which, after

9 people finished the treatment strategy study, the

10 subjects were entered in a trial to see if an added

11 medication might help them respond. And so we worked

12 together on that project in the late 1980s.

13 Q. Okay. Have you done any research with any

14 of the other of the three of these?

15 A. I can't recall that I've done any research.

16 I've talked with them, but I don't think I've

17 co-authored papers or anything like that with them.

18 Q. Have you given any talks or been on any

19 seminars with any of these three?

20 A. You know, I just -- I can't recollect that


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21 I have.

22 Q. Have you ever had breakfast, lunch or

23 dinner or any other meals with any of these three?

24 A. I would imagine at a science meeting that I

25 might have had lunch or dinner or breakfast with them

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1 as part of a group.

2 Q. And when and where would that have been?

3 A. Oh, I wouldn't have any recollection.

4 Q. So these are people that you've known for

5 many years.

6 A. Correct.

7 Q. Okay. Do any of them receive money from

8 the same drug companies that you have received money

9 from?

10 MR. ALSOP: Object on the basis of

11 foundation. Go ahead.

12 MS. AHMANN: Same objection. Also

13 vague.

14 THE WITNESS: I don't know. I don't

15 know who they've received money from.

16 BY DR. BARDEN:

17 Q. Do you know if any of them have acted as

18 paid consultants to any of the same drug companies

19 that you are a paid consultant to?

20 MS. AHMANN: Same objection.


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21 THE WITNESS: I don't have any

22 knowledge of that.

23 BY DR. BARDEN:

24 Q. Do you know if any of these three have been

25 involved in national scandals in the field of

273

1 psychiatry?

2 MR. ALSOP: Object as vague,

3 ambiguous. But go ahead.

4 THE WITNESS: I'm not aware of any.

5 BY DR. BARDEN:

6 Q. Do you know if any of them have been forced

7 to resign from their position as a result of one of

8 the most widely publicized scandals in the history of

9 American psychiatry?

10 MR. ALSOP: Same objection. It's

11 also argumentative. But go ahead.

12 THE WITNESS: No.

13 BY DR. BARDEN:

14 Q. You've never talked to Dr. Fawcett about

15 how he ended up in New Mexico, for example.

16 A. No.

17 MR. HUTCHINSON: I missed the last

18 part of the --

19 THE REPORTER: How he ended up in New


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20 Mexico, for example.

21 BY DR. BARDEN:

22 Q. Do you know where Dr. Fawcett worked before

23 he was in Southwest?

24 A. My recollection is that he worked at Rush

25 Presbyterian Hospital in Chicago.

274

1 Q. Do you know the circumstances under which

2 he left Rush?

3 A. No.

4 Q. Are there any changes to your resum since

5 the last time we've spoken?

6 A. I believe in the last month that -- I don't

7 have like a specific memory -- but that our research

8 group has published, I think maybe two or three new

9 papers.

10 Q. Do any of them have anything related to the

11 Cafe Study?

12 A. No.

13 Q. Nothing related to that at all.

14 A. Correct.

15 Q. Okay. Have you done anything -- strike

16 that.

17 The Cafe Study that is the subject of this

18 lawsuit, have those data been published, to the best

19 of your knowledge?


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20 A. To the best of my knowledge, they have

21 been.

22 Q. And how many studies have they been in?

23 A. I'm not quite understanding the question.

24 Q. I'm sorry. How many publications have

25 those data appeared in, either in whole or in part,

275

1 to the best of your knowledge?

2 A. To the best of my knowledge, I'm aware of

3 the publication of the main findings of the study I

4 believe was in the American Journal of Psychiatry.

5 Q. What, if any, steps have you taken to

6 inform the American Journal of Psychiatry that one of

7 the research subjects listed in the study as having

8 been on the medication was, in fact, not taking any

9 of the medication?

10 A. I've not taken any steps to -- I haven't

11 talked to the American Journal of Psychiatry.

12 Q. Okay. As the chairman of psychiatry, what,

13 if any, steps have you taken to instruct Dr. Olson to

14 contact that Journal to correct any errors in those

15 data?

16 A. I have taken no steps.

17 Q. Are you currently involved in any drug

18 trial research?


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19 A. I am currently involved in two studies.

20 I'm trying to think, make sure I'm accurate, but the

21 best of my knowledge, right now I'm involved in two

22 studies. One is a -- well, I'm involved in two

23 studies.

24 Q. Okay. Do those studies involve random

25 blood testing of the subjects to ensure that they're

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1 actually taking the medication involved in the study?

2 MR. ALSOP: Object as vague and

3 irrelevant. Go ahead.

4 MS. AHMANN: Join.

5 THE WITNESS: No.

6 BY DR. BARDEN:

7 Q. Do you consider that a potentially fatal

8 flaw to the research design used in the Cafe Study,

9 that is that none of the subjects were randomly

10 tested using blood samples to determine whether or

11 not they were actually taking the medication?

12 A. No.

13 Q. So you're continuing to use the research

14 methodology of just counting pills; is that correct?

15 MR. ALSOP: It's vague and also

16 irrelevant. But go ahead.

17 THE WITNESS: In the studies I'm

18 working on now, we're doing pill counts. We ask


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19 people if they're taking their medication and we are

20 not obtaining blood levels to -- for any reason.

21 BY DR. BARDEN:

22 Q. Okay. Are you aware of a history in the

23 field of psychiatry of efforts to conduct research in

24 such a way as to hide or minimize negative findings?

25 MR. ALSOP: Object as vague. Go

277

1 ahead.

2 MS. AHMANN: Join in that objection.

3 THE WITNESS: I'm sorry, with all the

4 discussion, would you mind repeating the question for

5 me?

6 BY DR. BARDEN:

7 Q. Well, are you aware in the history of

8 psychiatry of a pattern of the hiding of negative

9 research results?

10 A. I think the best way for me to answer the

11 question, especially in light of news that's come out

12 this week, that in research studies, specifically in

13 the material that came out this last week, that in

14 depression trials, there was a significant difference

15 in the rates of publication between the studies that

16 were positive and the studies that were negative.

17 And that was on the APA. You know, they have a daily


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18 thing. It was on that. And I can't remember which

19 journal that it was published in, but certainly quite

20 prominent in looking at an exploration of those

21 reports.

22 Q. Was that actually published in the New

23 England Journal of Medicine?

24 A. Seems I saw it on the Internet. I'm sorry,

25 I don't have a picture in my mind of where that was

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1 published.

2 Q. Okay. As a chairman of psychiatry, did you

3 find that troubling?

4 A. Yes, I did.

5 Q. And what about that did you find to be

6 troubling?

7 A. Well, as was stated in the abstract even of

8 that article, the authors indicated there may be many

9 sources or many reasons that that might have

10 happened. The first thing that I found troubling,

11 however, was that authors or sponsors may have

12 discussed not publishing the negative finding in some

13 way to enhance the outcome of the medicines being

14 studied.

15 In addition to that, as was pointed out by

16 the authors of the paper, and I think common

17 knowledge over the years, is that journals will


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18 frequently not publish negative results. Although I

19 believe they're doing a better job more recently. In

20 the past, I've been aware of journal editors saying

21 this is not -- a negative trial is not newsworthy, so

22 we don't want to publish it.

23 So that has also been, I'm sure you're

24 aware, discussed in our field and in other medical

25 specialties.

279

1 Q. Could you explain for the record what you

2 mean by "negative results"?

3 A. Oh, sure. By negative results, I would

4 mean that a study would -- a protocol would be

5 planned, the investigators would lay out what their

6 so-called primary findings or specific gains could

7 be, and then they would, you know, have -- they may

8 design the study to have a primary outcome. Pretty

9 common. And a negative study would be that there was

10 no, say in the placebo-controlled trial, that there

11 was no difference between the active compound and

12 placebo.

13 So to answer your question, that would be

14 one example of negative outcome of the study.

15 Q. What, if any, dangers to the public are

16 there when medical professionals were to minimize or


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17 hide negative data like that?

18 MR. ALSOP: Object as vague,

19 ambiguous and irrelevant. Go ahead.

20 MS. AHMANN: Join.

21 MR. HUTCHINSON: Join.

22 THE WITNESS: I think I'll start my

23 answer by saying hypothetically, because you're kind

24 of asking it, it appears to me, in a hypothetical

25 fashion, but it was pointed out that if you do a

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1 large number of studies with an intervention and for

2 whatever reason all the results are not published,

3 subsequent analyses of those studies may conclude

4 that there is a specific effect of the treatment.

5 And I know you're aware of assessments of treatments

6 such as effect sizes or meta-analyses, and if all the

7 data is not published from the results, then a

8 meta-analytic analyses of the studies will not

9 reflect all of the work done, say, for a specific

10 compound.

11 BY DR. BARDEN:

12 Q. So specifically in this, the New England

13 Journal of medical -- the New England Journal of

14 Medicine article discussed that there was -- there

15 had been an over-estimate of the benefits of those

16 drugs, right?


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17 A. To my recollection, that was one of their

18 conclusions.

19 Q. And that would be to the financial benefit

20 of the drug companies, wouldn't it?

21 A. I --

22 MS. AHMANN: Object, lack of

23 foundation.

24 MR. ALSOP: Lack of foundation. Go

25 ahead, if you know.

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1 THE WITNESS: Yeah, that I don't

2 know, because I don't know all the studies that were

3 involved and which ones may have been with generics

4 or not or anything like that.

5 BY DR. BARDEN:

6 Q. Well, if they're hiding studies that say

7 the drug has no benefit or actually injures people

8 and the publishing studies would say the drug is of

9 benefit and thus overestimating the benefit of the

10 drug, wouldn't that sell more drugs?

11 MR. ALSOP: Object as argumentative

12 and lacks foundation, vague. But go ahead.


14 THE WITNESS: I don't know how to

15 answer that.


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16 BY DR. BARDEN:

17 Q. Are you aware of other research indicating

18 that the financial interests of the investigators has

19 an effect on the results of drug studies?

20 A. No, not to my knowledge.

21 Q. You haven't seen any studies showing that

22 when the study is funded by the manufacturer of the

23 drug, they tend to have more positive results for

24 that drug.

25 MR. ALSOP: Repetitious and

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1 argumentative. Go ahead.

2 THE WITNESS: Well, Dr. Barden, I

3 think the best answer for me is that I have heard

4 conversations at scientific meetings, but I can't put

5 my finger on an article or a presentation. So, yes,

6 I'm aware of that. Some academicians have looked

7 into the matter you're questioning me about, but I

8 can't provide a more specific answer.

9 BY DR. BARDEN:

10 Q. If there was evidence showing that the

11 financial interest in the investigators appeared to

12 taint the research results, would that concern you as

13 a psychiatrist?

14 MR. ALSOP: It's vague and

15 irrelevant, but go ahead.


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16 THE WITNESS: I think before drawing

17 a conclusion, I would really want to, you know, know

18 in more specifics how the data had been collected and

19 more specifics about the issue.

20 BY DR. BARDEN:

21 Q. Okay. We've been talking about the recent

22 New England Journal of Medicine article indicating

23 that researchers dealing with antidepressants have

24 been hiding or not publishing negative results, and

25 I'm just wondering, looking back through the history

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1 of psychiatry, can you think of other examples of

2 similar types of problems: That is, the misreporting

3 or the selective reporting of data in order to make a

4 treatment appear to be more effective than it

5 actually is?

6 MR. ALSOP: Vague, ambiguous and


8 MS. AHMANN: Join.

9 THE WITNESS: A specific example

10 doesn't come to my mind.

11 BY DR. BARDEN:

12 Q. Are you aware of Dr. Freeman's research on

13 lobotomies, for example?

14 A. Well, I'm familiar with it, yes.


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15 Q. Are you familiar with any of the

16 methodological problems with Dr. Freeman's data or

17 how he reported those data?

18 A. I don't have a specific memory that comes

19 to my mind of he, say, for example, worked with the

20 prefrontal lobotomy data and then didn't report or

21 reported in any different way. But to be truthful, I

22 have read Dr. -- Mr. Jack El-Hai's biography of Dr.

23 Freeman in which -- and it goes through his entire

24 career and the ways that he began to become

25 interested in this technique, and I'm aware of his

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1 practicing this technique all around the country.

2 But I'm not aware of any specific area of, say, where

3 he collected data and then didn't report it or

4 didn't, say, report to the literature that he was

5 having certain side effect rates or anything like

6 that.

7 Q. Okay. Are you aware of the research of Dr.

8 Bennett Braun?

9 A. No, that name's not familiar to me.

10 Q. Okay. As a practicing psychiatrist, are

11 you aware of the world record in a settlement for a

12 psychotherapy negligent lawsuit against a

13 psychiatrist?

14 MR. ALSOP: Objection, irrelevant,


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15 immaterial.

16 MR. HUTCHINSON: I'll join.


18 THE WITNESS: No, I'm not.

19 BY DR. BARDEN:

20 Q. As a psychiatrist, are you interested in

21 the history of methodology errors and problems in the

22 field of psychiatry?

23 MR. ALSOP: Vague and ambiguous,


25 THE WITNESS: I am interested in

285

1 that, yes.

2 BY DR. BARDEN:

3 Q. But you have never heard of Dr. Bennett

4 Braun.

5 A. That's correct.

6 Q. Isn't it, in fact, the case that the Cafe

7 Study that is the subject of this lawsuit in fact

8 suffered from this very same difficulty, that is, the

9 study was constructed in such a way -- that is,

10 without any random blood testing of the subjects --

11 it was constructed in such a way as to minimize the

12 risk that negative findings would be discovered?

13 MS. AHMANN: Object, lack of


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14 foundation and vague.

15 MR. ALSOP: I'll join. Go ahead.


17 THE WITNESS: I'm sorry, Dr. Barden,

18 when you ask the question and then there's all that

19 conversation, I sometimes kind of lose it. If you

20 wouldn't mind just asking it again, I'd appreciate

21 it.

22 BY DR. BARDEN:

23 Q. In the Cafe Study that's the subject of

24 this lawsuit, there was no random blood testing of

25 the subjects, correct?

286

1 A. That's my understanding, yes.

2 Q. So you were counting on your paid

3 employees' pill counting methodology to determine

4 whether the patients were actually taking the

5 medication or not, correct?

6 A. I believe I would say, seeing as I was not

7 a designer of the study, et cetera, that the

8 principal investigators designed the study in this

9 way to rely upon pill counting and/or asking people

10 if they're using the medicine.

11 Q. Right. No random blood testing, correct?


13 Q. And you mentioned the principal


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14 investigators. Who were the principal investigators

15 of the Cafe Study that's the subject of this lawsuit?

16 A. To the best of my recollection, Dr. Jeffrey

17 Lieberman was the principal investigator of the Cafe

18 Study. And I'm not aware if he had like a

19 co-principal investigator or anything like that.

20 Q. And then just once again, to clarify for

21 the record, what was your role in the Cafe Study?

22 A. I was a co-investigator at the site at the


24 Q. So you were a co-principal investigator at

25 that site?

287

1 A. That's not what I said.

2 Q. Okay. Let's make sure we get it clear for

3 the record.

4 A. I said I was a co-investigator.

5 Q. Okay. So you were a co-investigator.

6 A. Correct.

7 Q. Okay. Now, isn't it true, Dr. Schulz,

8 that, to be frank, even an undergraduate psychology

9 student would have seen that the failure to do random

10 blood testing was, in fact, a fatal flaw in the

11 methodology of the Cafe Study?

12 MR. ALSOP: It's argumentative and


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13 it's repetitive. It's been asked already, but go

14 ahead.


16 MR. HUTCHINSON: Same objection.

17 What grades is this undergraduate work? Same

18 objection.

19 MR. ALSOP: You can answer, Doctor,

20 if you know.

21 THE WITNESS: I do not know what an

22 undergraduate psychology major would -- what their

23 comments would be about this study.

24 BY DR. BARDEN:

25 Q. Do you know the ranking of the psychology

288

1 department at the University of Minnesota?

2 A. By who?

3 Q. By anybody.

4 MR. ALSOP: Vague and ambiguous and



7 BY DR. BARDEN:

8 Q. Well, first of all, there are rankings that

9 are published, correct?

10 MR. HUTCHINSON: Is this the

11 psychology department you're asking about? Is that

12 the question?


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13 MR. ALSOP: I think so. I don't

14 know.

15 DR. BARDEN: We're getting off of

16 legal objections again. You can make a legal

17 objection, not a speech.

18 MR. HUTCHINSON: I'm asking what the

19 question is.

20 DR. BARDEN: Yeah, the question is to

21 him. If you want to say "vague," that's a legal

22 objection.

23 MR. HUTCHINSON: Vague.

24 BY DR. BARDEN:

25 Q. Okay.

289

1 A. My understanding of the question is you

2 asked me am I aware of the ranking of the Department

3 of Psychology at the University of Minnesota. I

4 asked you whose rankings, and you said there are

5 published rankings out there.

6 Q. I said are there published rankings?

7 A. Oh, I'm sorry. I thought I heard you say

8 there are. I'm aware the Department of Psychology at

9 the University of Minnesota has an outstanding

10 national, international reputation.

11 Q. Did you consult with anyone at the


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12 psychology department in terms of the quality or the

13 usefulness of your methodology for the Cafe Study?

14 MS. AHMANN: Objection, lack of

15 foundation.

16 THE WITNESS: No.

17 BY DR. BARDEN:

18 Q. Did you ever consider consulting with

19 anyone from the world famous psychology department at

20 the University of Minnesota for the Cafe Study?

21 A. No, I did not.

22 Q. Do you -- as a matter of simple logic,

23 would you agree that the study would have been far

24 better had you had random blood testing of the

25 subjects to determine if any of them were actually

290

1 taking the medication as prescribed?

2 MR. ALSOP: It's argumentative and

3 the question has been asked at least three times and

4 now it's repetitive. Go ahead, Doctor.

5 MS. AHMANN: Join in the lack of

6 foundation.

7 THE WITNESS: Okay. Could you repeat

8 the question so I make sure I understand what you're

9 asking?

10 BY DR. BARDEN:

11 Q. As a matter of simple logic, isn't it, in


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12 fact, the case that your failure to include random

13 drug testing, that is of a random sample of some

14 size, some representative size of the subjects in the

15 Cafe Study, your failure to do that random blood

16 testing to determine whether people were actually

17 taking their medication is a fatal mistake in your

18 design of that study?

19 MR. ALSOP: Same objections. Go

20 ahead.



23 THE WITNESS: First, I'd like to say

24 I was not the designer of the study. Dr. Lieberman

25 and his colleagues were. We were one side of many.

291

1 Secondly, I do not agree with your statement that

2 random blood tests would have made a difference in

3 interpretation of the compliance of the subjects in

4 the study.

5 BY DR. BARDEN:

6 Q. Have you ever heard the term "study of

7 nature"?

8 A. I'm not sure I have. What is that?

9 Q. Have you ever heard of accidents and acts

10 of nature that provide interesting and important


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11 scientific data?


13 ambiguous. Go ahead, if you understand.

14 THE WITNESS: Yes, I have, as a

15 matter of fact, and --

16 MR. ALSOP: That's the question, have

17 you heard it. That's all he's asking.

18 THE WITNESS: I'm sorry. Pardon me.

19 Yes.

20 BY DR. BARDEN:

21 Q. What's your understanding of that term as a

22 practicing research psychiatrist?

23 A. The case that I'm most familiar with, and

24 I'm sorry, I can't remember the name of the person in

25 this case, Finnias Gage comes to mind. Finnias Gage

292

1 was a --

2 Q. He was the one who was injured by the

3 railroad spike, neurological patient.

4 A. Well, he was a railroad worker, and he was

5 working at his job, and an explosive cap --

6 Q. Right.

7 A. -- evidently went off and a railroad spike,

8 as I recollect, went up under his jaw, but it was of

9 such a force that it went entirely through his brain.

10 He did not die, and he was taken home, and I would


29/76


11 suspect you recollect that he had a change in

12 personality. And even to this day, people will talk

13 about how the study, and I believe I've seen slides

14 at meetings of studying his skull and where the spike

15 might have gone, leads us to an understanding of his

16 impulsivity.

17 Q. Uh-huh.

18 A. So that would be a case that I'm aware of a

19 -- which you're calling a study of nature.

20 Q. Right. That's a case of things that happen

21 that are not predicted that can sometimes illuminate

22 interesting and important information of a science,

23 right?

24 A. I guess I'd say I generally agree with

25 that.

293

1 Q. Don't you think it's the case that Dan

2 Markingson's suicide will be a famous example of a

3 study of nature in that it exposed the fatal

4 limitation of the Cafe Study? That is, had Dan not

5 died, had he not received an autopsy, had his blood

6 not been tested, we would never have known that he

7 was not taking any medication, even though the

8 research protocol shows that he was taking his

9 medication as directed.


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10 MR. HUTCHINSON: Objection,

11 argumentative.

12 MR. ALSOP: It's argumentative, it's

13 a multiple question, it's vague and ambiguous,

14 irrelevant. Go ahead, Doctor.


16 MR. HUTCHINSON: Lack of foundation.

17 MR. ALSOP: Answer. Go ahead.

18 THE WITNESS: I don't agree with your

19 initial statement that this will be a famous study of

20 nature.

21 BY DR. BARDEN:

22 Q. Well, doesn't Dan Markingson's death and

23 the blood test and the fact that it's documented that

24 he was not taking medication when, in fact, the study

25 claims he was, doesn't this invalidate all such pill

294

1 counting methodology studies that fail to do random

2 blood testing?

3 A. I don't believe so, no.

4 Q. Isn't it, in fact, the case that the

5 failure of the Cafe Study to include random blood

6 testing is yet another example of the attempt of

7 psychiatry and the drug companies to construct

8 research in such a way as to hide negative evidence?

9 A. I can't make that conclusion, no.


31/76


10 Q. Since the last time we talked -- when was

11 that? Was that -- it was last spring or summer.

12 Since the last time we did part one of the

13 deposition, what, if any, funding have you received

14 from drug companies?

15 A. I'm just trying to gather my thoughts. And

16 I'm trying to place it in time, et cetera. So

17 some time ago.

18 MR. ALSOP: Just so -- the time frame

19 is June 22, '07.

20 THE WITNESS: Okay.

21 MR. ALSOP: So from that point on I

22 think is the question he's asking, I believe.

23 THE WITNESS: Okay. So since -- let

24 me begin my answer by saying, I'm not exactly sure

25 when I have received grants because the process is so

295

1 long from application to resubmission, et cetera.

2 But in this last year, perhaps in the second half of

3 the year, I applied for a grant to study extended

4 release with Triapine for borderline personality

5 disorder.

6 To the best of my knowledge, I

7 haven't received any other grants from the

8 pharmaceutical industry since our last -- since the


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9 last deposition.

10 BY DR. BARDEN:

11 Q. Okay. So you haven't received a check or

12 any funding for speaking, consulting or anything else

13 from a drug company since the last time we spoke.

14 A. So regarding receiving any other money, I

15 have received, I believe, $3,000 from Astrazeneca to

16 serve on their national advisory board. I'm not

17 aware of other checks. That's just to the best of my

18 knowledge.

19 Q. When were you asked to be on the national

20 advisory board for Astrazeneca?

21 A. My understanding is that Astrazeneca each

22 year takes a look at who they would like to have come

23 work with them on the national advisory board. So I

24 would imagine they asked me this, say, the late

25 summer, and I believe the meeting was in October.

296

1 Q. Okay. Have you ever served on the national

2 advisory board for Astrazeneca in a year in which you

3 were not a co-defendant in a lawsuit with

4 Astrazeneca?

5 MR. ALSOP: Object as vague. Go

6 ahead.

7 THE WITNESS: I would have to answer

8 yes.


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9 BY DR. BARDEN:

10 Q. And what year was that?

11 A. I believe I served on the national advisory

12 board with Astrazeneca 2001-2002. I was not a

13 defendant in a lawsuit in those years.

14 Q. And they paid you $3,000 to do that back

15 then?

16 A. To the best of my recollection, yes.

17 Q. What is your role as a member of the

18 national advisory board for Astrazeneca?

19 A. I have, in the past, served as -- so I have

20 -- you asked what my role was?

21 Q. Uh-huh.

22 A. I have served as the moderator for the

23 national advisory board meeting in recent years, but

24 my general role is to listen to the agenda, examine

25 the data, discuss the results of studies and/or

297

1 future plans for the development of their medication.

2 Q. Okay. And these are meetings that are

3 funded by Astrazeneca.

4 A. Correct.

5 Q. And your travel to and from these meetings

6 is paid for by Astrazeneca?



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8 Q. And you receive a fee for being there

9 that's paid by Astrazeneca.


11 Q. And the Cafe Study in which Dan Markingson

12 died in was funded by Astrazeneca.


14 Q. Mary Weiss sent you three letters. Do you

15 recall that?

16 A. I believe I've talked at our last

17 deposition that I recall receiving one letter from

18 Mary Weiss.

19 Q. Okay. When did you review your transcript

20 of the deposition that we took earlier?

21 A. Yesterday.

22 Q. Yesterday. So you just saw that yesterday.

23 A. Yes, that's when I reviewed it.

24 Q. Okay. So to the best of your knowledge, as

25 you sit there now, you've only received one letter

298

1 from Mary Weiss.


3 Q. And that was the one that was sent return

4 receipt, or certified.

5 A. Well, I don't know about that. If you

6 could give me the date, but it was in, I believe,

7 April. April of 2004.


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8 Q. In that letter, did Mary Weiss say Dr.

9 Olson would not speak to her?

10 MR. ALSOP: Doctor, do you want to

11 see the letter?

12 THE WITNESS: Yes.

13 MR. ALSOP: If you recall, you can

14 answer the question now.

15 THE WITNESS: I don't recall that,

16 no.

17 BY DR. BARDEN:

18 Q. You just saw the transcript yesterday,

19 though, in which we discussed this letter in detail.

20 A. I've reviewed my transcript. I do not

21 recall, from the deposition transcript, that we

22 discussed Mary Weiss indicating that Dr. Olson

23 wouldn't talk to her.

24 Q. Do you recall the letter indicating that

25 Dan was not being treated by Dr. Olson, that is he

299

1 hardly ever saw him? Do you recall that?

2 A. I don't recall that in the letter, no.

3 Q. Do you recall Mary Weiss complaining about

4 the treatment that her son was receiving?

5 A. That's not the way I remember it, no.

6 Q. What is the way you remember it?


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7 A. The way that I remember it is that Ms.

8 Weiss indicated that she was concerned for how Dan

9 was doing, that she recollected that when he was

10 first hospitalized, that he had taken an antianxiety

11 medication, and that she thought he felt better then,

12 and she expressed concern in the letter that she was

13 aware -- that she had the opinion that Dan had an

14 inner rage and that concerned her.

15 Q. Have you ever heard the term akathisia?

16 A. Yes, I have.

17 Q. What does that term mean?

18 A. Akathisia is, I guess I would say, a

19 technical term for what I think most people now know

20 as restless leg syndrome in which a person can feel a

21 creepy-crawly, uncomfortable feeling in their legs or

22 other parts of their body.

23 Q. Are you aware of anything beyond restless

24 leg syndrome that's related to akathisia?

25 A. I'm -- I thought I had described my

300

1 understanding of what akathisia was.

2 Q. Are you aware of any relationship between

3 akathisia and suicide, for example, as a licensed

4 psychiatrist practicing in the State of Minnesota?

5 A. I have a general memory, without a

6 reference, that some psychiatrists have published


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7 that the discomfort of akathisia, which has been

8 associated especially with some of the high potency

9 traditional antipsychotic medications, made patients

10 feel so uncomfortable that they -- that they had

11 suicidal thoughts.

12 Q. Were you aware of that research when you

13 gave me your answer about "restless leg syndrome"?

14 A. Sure.

15 Q. I'm going to read you some statements. I'd

16 like to know whether you agree or disagree with them.

17 "Knowledge of patient preferences is essential to

18 good clinical care, since the patient's cooperation

19 and satisfaction reflect the degree to which medical

20 intervention fulfills the patient's choices, values

21 and needs."


23 ambiguous. Go ahead.

24 BY DR. BARDEN:

25 Q. Do you agree with that statement?

301

1 A. You know, I would have to say that sounds

2 like a very nice general statement, that in practice,

3 if I were sitting with a patient, that I would want

4 to include those items. And I'm sure you're aware of

5 a term called the therapeutic alliance, and it seems


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6 to me that in that paragraph there are the essential

7 building blocks of how you develop a good

8 relationship with your patient.

9 Q. The therapeutic alliance is important,

10 isn't it, Doctor?

11 A. Oh, I couldn't agree with you more.

12 Q. And that emphasizes the ongoing nature of

13 informed consent, doesn't it, that informed consent

14 isn't just a signature on a page, it's an ongoing

15 therapeutic alliance between the doctor and the

16 patient; isn't that correct?

17 MR. ALSOP: It's vague and ambiguous,

18 calls for a legal conclusion. But go ahead, Doctor.


20 MR. HUTCHINSON: Same. Lacking

21 foundation.

22 MR. ALSOP: Go ahead, Doctor.

23 THE WITNESS: So let me take a minute

24 to answer this, if that's okay with you. I agree, I

25 have lectured that informed consent is not a

302

1 signature such as a sub prime loan mortgage that you

2 can just hold up and say, "Look, you signed this.

3 You owe me the money." The informed consent process

4 is one that needs to be discussed if the research

5 subject in the project has questions or has doubts


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6 about whether they would like to continue. It's, I

7 consider, part of -- I'll invent a term, but research

8 building of your relationship in the study.

9 BY DR. BARDEN:

10 Q. And informed consent needs to be

11 readdressed at various times sometimes with the

12 patient, doesn't it?

13 A. Yes.

14 Q. Such as like when you're recommending they

15 be committed would be a time to readdress informed

16 consent, wouldn't it?

17 MR. HUTCHINSON: Objection, lack of

18 foundation.

19 MR. ALSOP: Join.


21 THE WITNESS: I don't know if I could

22 agree to that specifically as it would need to be,

23 but I agree with your statement that informed consent

24 is an ongoing process and that questions by the

25 subject or concerns that the research team have need

303

1 to come up -- when they come up need to be addressed

2 with the patient, with the research subject.

3 BY DR. BARDEN:

4 Q. Next, Doctor, agree or disagree: "Patient


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5 preferences are legally significant because the

6 American legal system considers the patient-physician

7 relationship to be a fiduciary relationship in which

8 the fiduciary, such as a physician, has an obligation

9 to promote the best interests of persons who have

10 entrusted themselves to their physician's care."


12 ambiguous, calls for a legal conclusion. Go ahead.

13 THE WITNESS: I believe we discussed

14 the fiduciary responsibility in the past, and I don't

15 have an opinion on that quote you read.

16 BY DR. BARDEN:

17 Q. Okay. Next, agree or disagree: "Above

18 all, fiduciaries must avoid financial conflicts of

19 interest that could prejudice their clients'

20 interests."

21 MR. ALSOP: Same objections, vague

22 and ambiguous. Go ahead.

23 THE WITNESS: I'm sorry. I don't

24 know how to answer that.

25 BY DR. BARDEN:

304

1 Q. Okay. Next -- well, strike that. As a

2 licensed physician practicing in Minnesota, it's your

3 testimony under oath that you do not agree or don't

4 know how to answer my question to that statement,


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5 Doctor?

6 MR. ALSOP: It's now argumentative

7 and it's repetitious. He's answered the question.

8 Go ahead, Doctor.


10 THE WITNESS: What I said was I don't

11 know how to answer that question, not that I

12 disagree.

13 BY DR. BARDEN:

14 Q. You are subject to the licensing rules and

15 regulations of the State of Minnesota, correct?


17 Q. And as part of those regulations, you are

18 responsible to know the code of ethics that govern

19 your behavior as a physician, correct?

20 A. Yes, I am.

21 Q. Next statement: "If patient preferences

22 are ignored or devalued, patients are likely to

23 distrust and perhaps disregard physician's

24 recommendations." Do you agree or disagree with that

25 statement?

305

1 MR. ALSOP: Same objection, vague and

2 ambiguous. Go ahead.

3 THE WITNESS: I would only ask -- I


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4 know you're reading these and asking me to agree or

5 disagree. I would say in general clinical care, I

6 agree with that statement.

7 BY DR. BARDEN:

8 Q. Next, "Informed consent is defined as the

9 willing acceptance of a medical intervention by a

10 patient after adequate disclosure by the physician of

11 the nature of the intervention, its risks and

12 benefits, as well as of alternatives with their risks

13 and benefits." Do you agree or disagree?


15 ambiguous. It calls for a legal conclusion and

16 misstatement of the law. But go ahead.



19 MR. ALSOP: You can answer, Doctor.

20 THE WITNESS: I'm not sure I know how

21 to answer that question.

22 BY DR. BARDEN:

23 Q. Once again --

24 A. Give some time --

25 Q. As a licensed practicing physician in the

306

1 State of Minnesota, it's your testimony under oath

2 that you don't know how to answer whether you agree

3 or disagree with what I read you; is that correct?


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4 MR. ALSOP: That's argumentative and

5 repetitious. He's answered the question. Go ahead,

6 Doctor, you can answer.

7 MR. HUTCHINSON: Same. Join.

8 THE WITNESS: Well, given your

9 response, and just to be very careful and sure, would

10 you reread the quote for me?

11 BY DR. BARDEN:

12 Q. "Informed consent is defined as the willing

13 acceptance of any medical intervention by a patient

14 after adequate disclosure by the physician of the

15 nature of the intervention, its risks and benefits,

16 as well as of alternatives with their risks and

17 benefits."

18 MR. ALSOP: Same objections. Go

19 ahead.

20 THE WITNESS: In my clinical practice

21 as a psychiatrist in Minnesota, I agree with that

22 statement.

23 BY DR. BARDEN:

24 Q. Next, "It is clearly unethical to do

25 anything to a patient that will not benefit and may

307

1 even harm the patient in order to benefit the

2 physician or some other party." Do you agree with


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3 that?

4 A. My pause is that I can't think of a

5 situation to which that applies.

6 Q. Do you agree with that statement or not,

7 Doctor?

8 A. I don't know how to answer that.

9 Q. Next, "In order for patients to be allowed

10 to make reasonable choices, they must be provided

11 with adequate and truthful information. This

12 includes disclosure about the physician's financial

13 incentives that could influence the recommendations

14 that the physician makes to the patient." Do you

15 agree or disagree with that?

16 MR. ALSOP: Same objections, vague

17 and ambiguous and argumentative, but go ahead.

18 THE WITNESS: I don't agree with that

19 statement.

20 BY DR. BARDEN:

21 Q. And why not?

22 A. My personal opinion is that a person in any

23 medical specialty may collaborate or work with

24 industry and/or device makers, et cetera, and going

25 through all of the different relationships they may

308

1 have, in my opinion, could confuse and diminish the

2 communication between a doctor and his patient


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3 deciding on the course of treatment for that person.

4 Q. And in your model, Dr. Schulz, that you've

5 just described to us, who's the person that gets to

6 decide what financial conflict of interest

7 information is disclosed or withheld from a patient?

8 MR. ALSOP: It's argumentative, but

9 go ahead.

10 THE WITNESS: If you could repeat --

11 I'm sorry. I just didn't understand the question.

12 Just the way -- I think you were asking about who --

13 MR. ALSOP: Well, just have him

14 rephrase it.

15 BY DR. BARDEN:

16 Q. Have you had any training in biomedical

17 ethics?

18 A. I have had -- I've taken the courses at the

19 University of Minnesota that are required for us to

20 participate in clinical research.

21 Q. And isn't this statement part of that

22 training?

23 A. I'm not aware. I don't recall that, no.

24 Q. Do you recall anything at all like this

25 being taught to you?

309



46/76


2 but go ahead.

3 THE WITNESS: No, I don't. Not at

4 this time.

5 BY DR. BARDEN:

6 Q. Okay. I'm going to read it to you again.

7 We're kind of running low on time, but let me go over

8 this again. "In order for patients to be allowed to

9 make reasonable choices, they must be provided with

10 adequate and truthful information. This includes

11 disclosure about the physician's financial incentives

12 that could influence the recommendations the

13 physician makes to the patient." Do you agree or

14 disagree with that?

15 MR. ALSOP: That's been asked and

16 answered, it's repetitious. Go ahead, Doctor.

17 THE WITNESS: Again, the best I can

18 say is that I don't know how to answer your question

19 yes or no.

20 BY DR. BARDEN:

21 Q. Okay. So you were a co-investigator on the

22 Cafe Study, correct?

23 A. For the University of Minnesota site. And

24 just to remind you, remember that Cafe was a study,

25 to the best of my recollection, designed by Dr.

310

1 Jeffrey Lieberman who, I think you know, is an expert


47/76


2 in first episode schizophrenia, and that he proposed

3 to have a multi center trial, and our -- the

4 University -- Dr. Olson, I guess I should say, as a

5 faculty member at the University of Minnesota, was

6 selected to be the principal investigator at our

7 site, and I was a co-investigator to Dr. Olson at the


9 Q. Okay. We discussed last time, you wrote a

10 letter to Mary Weiss.

11 A. Yes, I did.

12 Q. And Dr. Olson participated in crafting that

13 letter with you, correct?

14 A. I think I would explain it that I received

15 a letter, I met with Dr. Olson, and I believe also

16 Jeanne Kenney, reviewed Ms. Weiss' letter with them,

17 drafted a response and I believe Dr. Olson may have

18 changed one or two words in my letter.

19 Q. And the letter you sent out reflected his

20 changes, correct?

21 A. I incorporated his changes in my final

22 letter back to Ms. Weiss, yes.

23 Q. Thus you worked together to craft the

24 letter.

25 A. Correct. Uh-huh.

311


48/76


1 Q. In your meeting with Dr. Olson and Ms.

2 Kenney to review Ms. Weiss' letter and the treatment

3 of Dan Markingson, did you suggest to Dr. Olson that

4 he should obtain Dan's high school records? Yes or

5 no?

6 A. No.

7 Q. Did you suggest to Dr. Olson that he should

8 obtain Dan's college records?

9 A. I did not.

10 Q. Did you suggest to Dr. Olson that he should

11 obtain Dan's fraternity records?

12 A. I did not.

13 Q. Did you suggest that he should interview

14 Dan's former girlfriend?

15 A. I did not.

16 Q. Did you suggest that he should review Dan's

17 previous medical records?

18 A. I did not suggest that to Dr. Olson when we

19 met about Ms. Weiss' letter.

20 Q. Did you suggest that Olson, Dr. Olson had a

21 duty to report Mary's letter of complaint to the IRB?

22 Yes or no?

23 A. No, I did not.

24 DR. BARDEN: Okay. Our tape is going

25 to expire shortly. So I suggest we take a five

312


49/76


1 minute break and we'll see how much time we have

2 remaining.

3 VIDEOGRAPHER: We are now off the

4 video record.

5 (A brief recess took place.)

6 VIDEOGRAPHER: We are now on the

7 video record.

8 BY DR. BARDEN:

9 Q. Dr. Schulz, we were discussing experiments

10 of nature earlier.

11 A. Yes.

12 Q. And the notion of Dan Markingson, his

13 death, leading to an autopsy, leading to a blood

14 test, documenting that he was, in fact, taking no

15 medication being an experiment of nature. Do you

16 recall those questions?

17 A. Yes, I do.

18 Q. If someone were to write up that as an

19 experiment of nature in order to argue that it

20 exposed the fatal flaw in the so-called pill counting

21 methodology, what would be the best journal to

22 publish that in?


24 argumentative --

25 BY DR. BARDEN:

313


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1 Q. To the best of your knowledge.

2 MR. ALSOP: Vague and ambiguous,

3 argumentative and irrelevant. But go ahead.

4 MR. HUTCHINSON: Objection, lacking

5 foundation and join in the other objections.

6 MS. AHMANN: Join in all.

7 THE WITNESS: I really don't have an

8 opinion of which would be the appropriate journal for

9 such a case report.

10 BY DR. BARDEN:

11 Q. Okay. We talked earlier about the theory

12 that Dan Markingson's death, the failure of the pill

13 counting methodology to dramatically underreport the

14 number of people who are failing to take medication

15 was, in fact, the last in a long stream of

16 experiences in psychiatry in which this had happened,

17 starting with Dr. Freeman, going through Dr. Bennett

18 Braun, talking about the -- well, I guess we haven't

19 talked about it yet -- the flat lining research, the

20 famous psychiatrist who tried to erase his patients'

21 memories and build their personalities from scratch,

22 et cetera, et cetera. Do you recall that discussion?

23 MR. ALSOP: Object as multiple in

24 nature, argumentative and a misstatement of

25 testimony. Go ahead.


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314

1 MR. HUTCHINSON: Same objection.

2 Misstating the evidence.

3 MS. AHMANN: Join.

4 MR. HUTCHINSON: Join in the lack of

5 foundation.

6 THE WITNESS: I'm sorry to say again

7 that the question was really very long and it had

8 some kind of multiple parts --

9 BY DR. BARDEN:

10 Q. Fair enough.

11 A. But I do remember we started talking about

12 Finnias Gage and experiments of nature. But could

13 you maybe amplify or clarify the points about the

14 measurement of medications as parts of the studies?

15 Q. Sure. Do you recall talking about Dr.

16 Freeman?

17 A. Oh, sure.

18 Q. He was the lobotomizer. And you were not

19 aware of him manipulating data though, right?

20 A. Correct.

21 Q. And we talked about Dr. Bennett Braun, but

22 you didn't seem to be aware of Dr. Braun.

23 A. I don't recognize that name.

24 Q. Okay. Are you aware, in the history of

25 psychiatry, of other psychiatrists who have used


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315

1 nefarious research methods?

2 MR. ALSOP: It's irrelevant and

3 argumentative, but go ahead.

4 MS. AHMANN: Object as vague as well.


6 THE WITNESS: I'm aware of a case, I

7 believe, around the mid '80s, and I'm sorry I don't

8 remember the psychiatrist's name, but let me take a

9 minute to describe what happened. A psychiatrist, I

10 think psychiatrist or psychologist, working in the

11 department of psychiatry, was publishing papers about

12 the effects of antipsychotic medications on people

13 with developmental deficiencies at public

14 institutions. His work led everybody to be very

15 cautious about the use of, I think especially

16 antipsychotic medications. And people were extremely

17 impressed with his productivity. And clarification

18 of his records led to finding out that he had not,

19 indeed, collected the data that was part of his

20 report.

21 So, yeah, I'm aware of that, an

22 instance -- I'm aware of that instance. It was kind

23 of a dramatic one for me.

24 BY DR. BARDEN:

25 Q. Okay. And then we talked about the recent


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316

1 publication in the New England Journal of Medicine

2 where it looked like, in terms of the antidepressant

3 literature, that negative results, that is, the drug

4 not being very effective, tended to be suppressed,

5 correct? We discussed that?

6 A. Well, we discussed the paper. I'm not sure

7 I necessarily agree with your conclusions that --

8 because I said that there may have been -- and the

9 author said, there may have been multiple reasons for

10 the difference in the positive reports and negative.

11 We did discuss it may have also had to do with

12 editors of scientific journals wanting the most

13 newsworthy things in the their publications and

14 saying, "Gee, this is a negative trial. I don't want

15 to publish it." And we know in our field that

16 happened.

17 Q. And I think we discussed briefly why that

18 was troubling to you.

19 A. Yes, we did.

20 Q. Have we talked about the research

21 indicating that the research on antipsychotics has

22 been skewed in that it didn't compare new and old

23 drugs, it just compared between the new drugs, and

24 finally, when someone looked at it, the new and old

25 drugs aren't that different, they're just much, much


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317

1 more expensive? Are you aware of that particular

2 controversy?

3 MS. AHMANN: I'm going to object,

4 lack of foundation and vague.

5 MR. ALSOP: I'll join. Go ahead.

6 You can answer.

7 THE WITNESS: So I'm aware there was

8 a controversy, and I'm aware that when the group of

9 medicines I think you know are called the atypical

10 antipsychotics began to emerge, that initial trials

11 would have, as a general design, that they would use

12 one of the new compounds like an atypical

13 antipsychotic, they would compare to an older

14 antipsychotic -- I think almost all is Haloperidol in

15 these studies, and placebo. And so although more

16 recently, there have been discussions of, are the

17 atypicals really any better than the old ones, my

18 recollection of the early trials is the atypical

19 antipsychotics were compared to traditional

20 antipsychotics versus placebo.

21 So for example, Dr. Stephen Marder at

22 UCLA and Dr. Mibach (phonetic) described the results

23 of the Risperidone versus Haloperidol versus placebo

24 studies, and to the best of my recollection, what


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25 they reported is that the Risperidone and Haloperidol

318

1 were both better than placebo, but that at

2 recommended doses, the Risperidone had many fewer

3 movement disorder side effects.

4 And so then that was kind of, at the

5 time that the atypicals were coming out, that was

6 felt to be a pretty important thing.

7 BY DR. BARDEN:

8 Q. Are you aware of any lawsuits -- are you

9 aware of any lawsuits by states to recover billions

10 of dollars spent on the newer drugs when the old ones

11 were just as effective? Are you aware of such a

12 lawsuit? Yes or no? And our time is limited, so I'm

13 going to ask you to answer yes or no whether you're

14 aware of those or not.

15 A. I'm not aware of those.

16 Q. Those are brought by state attorneys

17 general. You're not aware of any of that.

18 A. No.

19 Q. Okay. You're not aware of any criticism in

20 the literature of recent studies that have just

21 looked at the differences between the newer drugs

22 failing to compare them with the older drugs? Are

23 you aware of any criticisms of that nature?

24 A. Well, I don't know if I'd phrase it


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25 criticisms, but even in our last deposition we did

319

1 discuss the, what's called the Cady Study which did

2 have an older medicine, and I think you even brought

3 up some thoughts by Dr. Lieberman. So I'm aware

4 there's some controversy and there's a lot of

5 discussion.

6 Q. And that would be perhaps -- could be

7 considered another example of the literature skewing

8 the data to enrich drug companies, correct?

9 A. I can't agree with that.

10 Q. Okay. And then -- okay. So you don't

11 subscribe to the view that the Cafe Study is simply

12 the last in a long chain of business as usual which

13 is constructing research to minimize negative results

14 and to produce data that will overestimate the

15 effectiveness of the most expensive medication

16 possible.

17 A. I don't agree with that statement.

18 Q. Okay. All right. Last time we talked

19 about an audit that was done at the University of

20 Minnesota. Do you recall that?

21 A. Yes, I do.

22 Q. Has there been any update on that audit

23 that you're aware of? That is the audit on the


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24 performance of the Department of Psychiatry.

25 A. Uh-huh.

320

1 Q. Do you recall that discussion?

2 A. No. I do recall the discussion in that all

3 departments at the University of Minnesota have

4 audits. I don't know if they're like every seven or

5 10 years. And then -- I'm answering your question.

6 Q. I don't mean to break you off, but my time

7 is limited. Has there been an update to that audit

8 or not?

9 A. There has been -- there was an action plan

10 that was recommended by the auditor, and the

11 department of psychiatry has responded to those and

12 then those are reported to the regents.

13 Q. Okay. Have they collected any further data

14 such as the data showing that many employees were

15 afraid to report problems?

16 MR. ALSOP: Object on the basis of

17 foundation. Go ahead, if you know.

18 THE WITNESS: To my understanding,

19 they have not reassessed the staff and the faculty on

20 that question, but what we did in response to their

21 request about that, our remedy was to have quarterly

22 all-department meetings, not just faculty meetings,

23 and I've done that.


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24 BY DR. BARDEN:

25 Q. Okay. How much does a blood test cost, for

321

1 example, just a simple blood test to see if a patient

2 is taking medication or not? What is the typical

3 cost of that?


5 ambiguous, lacking foundation. Go ahead.

6 THE WITNESS: I don't know the cost.

7 MS. AHMANN: Join.

8 BY DR. BARDEN:

9 Q. Do you have any idea at all?

10 A. No.

11 Q. It would be $100 maybe?

12 A. I'm sorry. I don't know.

13 Q. Have you ever ordered a blood test for any

14 of your psychiatry patients in your practice, any

15 kind of blood test?

16 A. You mean a blood test to determine the

17 level of medication in the person's body?

18 Q. Let's start there. Have you ever done

19 that?

20 A. Yes, I have.

21 Q. How much did that cost?

22 A. I don't know.


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23 Q. This is very commonly done, for example,

24 for Lithium, correct?

25 A. Oh, I'm sorry. I didn't maybe understand

322

1 the direction. Yes, I do obtain, in the patients I

2 work with who take Lithium, Lithium blood levels.

3 Q. And how much are those blood tests?

4 A. I don't know how much those cost. The

5 patient goes to the laboratory, the laboratory is in

6 the hospital, the hospital sends the bill to the

7 patient.

8 Q. But you have no idea how much they are.

9 A. No, I'm sorry, I don't.

10 Q. But they're not very expensive, to the best

11 of your knowledge.

12 MS. AHMANN: Object.

13 BY DR. BARDEN:

14 Q. You don't think they're -- do you think

15 they're $1,000?

16 MR. ALSOP: That's argumentative,

17 it's speculative.

18 MR. HUTCHINSON: Same. Lack of

19 foundation.


21 BY DR. BARDEN:

22 Q. As a psychiatrist practicing in the State


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23 of Minnesota in the year 2008, do you have any

24 understanding at all, within $100, of how much a

25 blood test costs to determine the level of medication

323

1 in a patient's blood?

2 MR. ALSOP: Repetitious,

3 argumentative and irrelevant. Go ahead, Doctor.

4 MR. HUTCHINSON: Same. Lack of

5 foundation.

6 MS. AHMANN: Join.

7 THE WITNESS: I'm sorry. We started

8 off talking about Lithium.

9 BY DR. BARDEN:

10 Q. I'm sorry. My time is limited.

11 A. I understand that.

12 Q. Do you have any idea what it costs or not,

13 as a licensed psychiatrist practicing in Minnesota?

14 A. I have clarified that it is my

15 understanding that tests for different medications

16 are different, that a Lithium level may be

17 inexpensive, that a level for another medication

18 might be a lot higher, because the methodologies are

19 different.

20 Q. How much higher would they be for the

21 medications in the Cafe Study?


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22 A. I have no idea what the charges are for

23 medication levels for the medications in the Cafe

24 Study.

25 Q. And you couldn't even guess to within a

324

1 $1,000, for example.

2 MR. ALSOP: It's argumentative,

3 Doctor. Don't guess.

4 MS. AHMANN: Join.

5 THE WITNESS: No, I can't.

6 (WHEREUPON, Deposition

7 Exhibit No. V was marked for

8 identification by the Reporter.)

9 BY DR. BARDEN:

10 Q. Okay. I'll show you what's been marked as

11 Exhibit V. Could you identify that for us, Doctor?

12 DR. BARDEN: And can I ask how much

13 time we have left as we're proceeding?

14 VIDEOGRAPHER: You had 33 to start?

15 DR. BARDEN: Yes.

16 VIDEOGRAPHER: Eighteen minutes.

17 MS. AHMANN: Counsel, do you have any

18 extra copies of V?

19 DR. BARDEN: This is the subpoena

20 notice. I think you all have copies of that.

21 BY DR. BARDEN:


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22 Q. Okay. Did you receive this notice, Doctor?

23 A. Well, I'm not --

24 Q. Let me ask you this --

25 A. -- I'm no not familiar with this notice.

325

1 Q. Have you ever seen one of these before?

2 MR. ALSOP: "One of these"? Object

3 as vague.

4 THE WITNESS: I'm sorry, I'm having

5 trouble identifying what this is.

6 BY DR. BARDEN:

7 Q. Okay. Do you recall the last time I took

8 your deposition I showed you one of those?

9 A. No, I don't. I'm sorry.

10 Q. You don't. Okay. I'm looking at what's

11 been marked as Exhibit V, Mary Weiss versus Board of

12 Regents for the University of Minnesota, et al. It

13 says, "Amended videotape deposition notice of Dr.

14 Charles Schulz." Do you see that on the front page?

15 A. Yes, I do.

16 Q. And it says on page 2 of what's been marked

17 as Exhibit V that we will take the videotape

18 deposition of you, Charles Schulz, on Friday January

19 18th. That would be today, correct?

20 A. That's today.


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21 Q. Starting at 8:30 a.m., and that's pretty

22 much when we started, isn't it?

23 A. Uh-huh.

24 Q. And that you are to bring with you for

25 inspection and copying a complete copy of the medical

326

1 record file on plaintiff Dan Markingson from the

2 University of Minnesota. Do you see that language?

3 A. Yes, I do.

4 Q. Okay. So my question to you is, did you

5 bring any files here today pursuant to that lawful

6 subpoena?

7 MR. HUTCHINSON: Objection, that's

8 not a subpoena. I just --

9 MR. ALSOP: I object as a

10 misstatement. It's a deposition notice.

11 BY DR. BARDEN:

12 Q. Subject to that notice, did you bring any

13 records here today?

14 A. No.

15 Q. Have you ever brought any records to this

16 deposition or the previous deposition?

17 A. No, I have not.

18 Q. Have you examined any records in this case

19 at anytime, either before the last deposition or

20 before this one?


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21 A. No.

22 Q. You haven't looked at any medical records

23 of any kind whatsoever.


25 Q. You haven't looked at any Cafe Study data

327

1 records?

2 A. No.

3 Q. You haven't looked at any medical files of

4 any kind.

5 A. Correct.

6 Q. You haven't looked at the informed consent

7 for this study?

8 A. I don't have a recollection, but in the

9 period of time from the startup, I may have seen the

10 informed consent form.

11 Q. Okay. So you have not looked at anytime at

12 any medical files whatsoever for Dan Markingson.

13 A. Correct.

14 Q. Okay. Have you ever heard anyone claim

15 that it's "unethical" to take a blood test?


17 vague and ambiguous.

18 THE WITNESS: I don't recall hearing

19 a person say that.


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20 BY DR. BARDEN:

21 Q. Have you ever heard anyone say it's --

22 A. Oh, I'm sorry. I have a recollection of

23 discussion of times when we're working on the ward

24 that, if a patient comes on to, say, one of our wards

25 at the University of Minnesota Medical Center, if a

328

1 patient refuses a blood test that's been ordered by

2 the psychiatrist, to go ahead and take the blood when

3 they're refusing, would be unethical.

4 Q. Sure. Just like any other medical

5 procedure, correct?

6 A. Correct.

7 Q. Okay. And that would be true whether it's

8 part of a research protocol or not. I mean, there

9 are research protocols that require the taking of

10 blood tests, correct?

11 MS. AHMANN: I'm going to object as

12 to multiple questions and vague.

13 MR. ALSOP: I'll join. It's vague.

14 Go ahead.

15 THE WITNESS: Within -- as a general

16 comment, I'm aware that there are studies in which

17 blood tests are required for -- at various points in

18 the study.

19 BY DR. BARDEN:


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20 Q. Okay. Have you ever read any research

21 about akathisia relating it to rage or --

22 A. No.

23 Q. -- anger?

24 A. No.

25 Q. Pardon?

329

1 A. No.

2 Q. Have you ever seen any research relating

3 akathisia to violent acts?

4 A. To the best of my recollection, I recall

5 some work by Dr. Van Putten at UCLA at the Wadsworth

6 VA discussing in his paper about Haloperidol and

7 Thiothixene that patients with akathisia on their

8 wards were agitated. I don't recall his saying that

9 it led to violence. But to the best of my

10 recollection, I am aware of his published paper about

11 that in the Archives of General Psychiatry.

12 Q. Okay. I'm not sure if I asked you this

13 last time, but I just want to clarify for the record:

14 You did not report Mary Weiss' certified letter to

15 you to the IRB, correct?

16 A. You asked me that before and I said I did

17 not.

18 Q. Okay. You did not instruct Dr. Olson to


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19 report Mary Weiss' letter to the IRB, correct?

20 A. That is correct.

21 Q. When you met with Ms. Kenney and Dr. Olson

22 to go over the treatment of Dan Markingson, did they

23 report to you that Mary Weiss had complained to them

24 repeatedly about the nature of the study and its

25 impact on her son, Dan Markingson?

330

1 MR. ALSOP: Object as a multiple

2 question. Go ahead.

3 THE WITNESS: My recollection is that

4 they indicated that Ms. Weiss had raised concerns

5 with him during the time of the study, but that's

6 just thinking back to a meeting that occurred a

7 number of years ago.

8 BY DR. BARDEN:

9 Q. Uh-huh. And at that time, you did not

10 instruct Dr. Olson and Ms. Kenney to report those

11 complaints to the IRB, did you?

12 A. No, I did not instruct them to report that

13 to the IRB.

14 Q. And you did not report what they told you

15 about Mary Weiss' numerous complaints, you did not

16 report that to the IRB yourself, correct?

17 A. Correct.

18 Q. What, if any, independent investigation of


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19 the situation with Dan Markingson, that is, his

20 mother making multiple complaints -- did you make any

21 other independent investigation, other than talking

22 to Dr. Olson and Ms. Kenney?

23 A. I did not.

24 Q. In your letter responding to Mary Weiss,

25 you failed to disclose your financial conflict of

331

1 interest as a co-investigator of the Cafe Study; is

2 that right?

3 MR. ALSOP: Object as argumentative,

4 but go ahead, Doctor.

5 MR. HUTCHINSON: Same.

6 MS. AHMANN: Same.

7 THE WITNESS: I did not.

8 DR. BARDEN: How much time do I have

9 left?

10 VIDEOGRAPHER: Ten minutes.

11 DR. BARDEN: We'll reserve 10 minutes

12 for rebuttal, if necessary. We'll reserve those 10

13 minutes for final rebuttal.

14 MR. ALSOP: So you want to rebut if

15 there's --

16 DR. BARDEN: Well, you're going to

17 ask questions, right?


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18 MR. ALSOP: No.

19 DR. BARDEN: You're not. Is anyone

20 going to ask questions?

21 MR. HUTCHINSON: I have no questions.

22 MS. AHMANN: I have nothing.

23 MR. ALSOP: So there's no need for

24 rebuttal.

25 DR. BARDEN: Why don't we take a

332

1 brief break. I'll look through my notes and see if

2 we're done.

3 (A brief recess took place.)

4 VIDEOGRAPHER: We're now on the video

5 record.

6 BY DR. BARDEN:

7 Q. Okay. In our last 10 minutes, Dr. Schulz,

8 I just have a few more questions for you. When did

9 you first became aware that when Dan Markingson

10 signed the informed consent form in this study he was

11 under a court-ordered stay of commitment?

12 MR. ALSOP: It's a misstatement of

13 the evidence, and if you've learned anything from me,

14 just --

15 THE WITNESS: Okay.

16 MR. ALSOP: Go ahead and answer.

17 THE WITNESS: I don't know when I


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18 learned that.

19 BY DR. BARDEN:

20 Q. When did you first learn that when he

21 signed the informed consent form he was under a court

22 order to comply with the recommendations of his

23 treatment team, including Dr. Olson?

24 A. I'm sorry, I can't recollect. I don't

25 know.

333

1 Q. When did you first became aware that Dr.

2 Olson attempted to recommit or get another stay of

3 commitment against Dan Markingson without redoing the

4 informed consent?

5 A. I don't recollect when I learned that.

6 Q. When did you first learn that Dan

7 Markingson had no medication in his blood stream,

8 that is, he was not taking medication when he died?

9 A. I think my best answer would be that I was

10 aware, and I can't remember how, that in the autopsy

11 report, that there was -- that no medication, none of

12 the medications in the study were in his blood.

13 Q. When did you first become aware of that

14 autopsy report?

15 A. I don't know. I'm sorry.

16 Q. Was it during the deposition, the first


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17 deposition?

18 MR. ALSOP: Object as speculative.

19 THE WITNESS: Yeah, I'll just say I

20 don't know. Sorry.

21 BY DR. BARDEN:

22 Q. Okay. When did you first became aware that

23 Mary Weiss had warned the study staff that her son

24 might become violent and that he was decompensating?

25 A. I'm not --

334


2 lack of foundation and a misstatement.

3 MR. ALSOP: Go ahead, Doctor.

4 THE WITNESS: Yeah, I'm not aware I

5 ever learned that.

6 BY DR. BARDEN:

7 Q. Were you aware that Mary Weiss ever warned

8 the staff that there might be violence if Dan

9 continued in the study?

10 MR. ALSOP: It's vague and ambiguous.

11 Go ahead.

12 THE WITNESS: No, I'm not aware of

13 her saying that to the study staff.

14 BY DR. BARDEN:

15 Q. That he might hurt himself or someone else?

16 Never said anything like that?


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17 A. To the best of my recollection, the

18 information I have about that is that in her letter

19 to me, she expressed concern about him having, what I

20 think she termed, an inner rage. But that's the

21 closest I can come to your question.

22 Q. Okay. So in your consultation with Dr.

23 Olson and Ms. Kenney regarding the treatment of Dan

24 Markingson, they did not inform you of any specific

25 warnings or fears that Mary Weiss had regarding

335

1 potential violence.

2 A. No, not to the best of my recollection.

3 Q. I'd like to read you a statement onc

charles schulz deposition part two 2008

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