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1 STATE OF MINNESOTA DISTRICT COURT
2 COUNTY OF HENNEPIN FOURTH JUDICIAL DISTRICT
Case Type: Wrongful Death
3 - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Court File No.
4 Mary Weiss, on her own behalf, 62-CO-06-11934
and as the next of kin and trustee
5 of the Estate of Dan Markingson,
deceased,
6
Plaintiff,
7
-vs-
8
Board of Regents for the University of
9 Minnesota; Dr. Stephen Olson;
Dr. Charles Schulz; Institutional,
10 Review Board for the University of Minnesota;
Astrazeneca Pharmaceuticals LP;
11 Astrazeneca LP and Zeneca, Inc.,
12 Defendants.
13 - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
14 Deposition of: CHARLES SCHULZ, M.D.
15 Taken at: Gislason & Hunter, LLP
701 Xenia Avenue South
16 Suite 500
Minneapolis, Minnesota
17
Date: June 22, 2007
18
Commencing at: 9:05 a.m.
19
20
21
22
By JANICE L. YOUNG, RPR
23
12151 Gantry Lane
24 Apple Valley, Minnesota 55124
800-844-6420 * 952-431-1252
25
2

1 Video deposition of CHARLES SCHULZ, M.D., taken
pursuant to Notice to Take Oral Deposition, under the
2 Rules of Civil Procedure, for the District Courts of
Minnesota, at Gislason & Hunter, 701 Xenia Avenue
3 South, Suite 500, Minneapolis, Minnesota, commencing
at approximately 9:05 a.m., on the 22nd day of June,
4 2007, before Janice L. Young, Notary Public in and
for the State of Minnesota.
5
- * -
6
7 APPEARANCES:
8 R. CHRISTOPHER BARDEN, Ph.D., J.D., Esq.,
GALE D. PEARSON, Esq., and STEPHEN J. RANDALL, Esq.,
9 of the law firm of Pearson, Randall & Schumacher,
Suite 1025 Fifth Street Towers, 100 South Fifth Street,
10 Minneapolis, Minnesota 55402 appeared for and on behalf
of Plaintiff.
11
DAVID D. ALSOP, Esq., and ANGELA M. NELSON, Esq.,
12 of the law firm of Gislason & Hunter, 701 Xenia Avenue
South, Suite 500, Minneapolis, Minnesota 55416 appeared
13 for and on behalf of Defendants Olson and Schulz.
14 RUTH FLYNN, Esq., Risk Management Operations
Director, Suite 200, 720 Washington Avenue SE,
15 Minneapolis, Minnesota 55414 appeared for and on behalf
of the University of Minnesota Physicians.
16
DAVID C. HUTCHINSON, Esq., and CHARLES A. GROSS,
17 Esq., Geraghty O'Loughlin & Kenney, 1400 Ecolab University
Center, 386 North Wabasha Street, St. Paul, Minnesota
18 55102-1308 appeared for and on behalf of Defendant
Board of Regents of the University of Minnesota.
19
BRIDGET M. AHMANN, Esq., of the law firm of
20 Faegre & Benson, 2200 Wells Fargo Center, 90 South
Seventh Street, Minneapolis, Minnesota 55402-3901
21 appeared for and on behalf of Defendants AstraZeneca
and Zeneca.
22
23 Also Present: Mary Weiss
24 Video Technician: Bob Durland
25
3

1 I N D E X
2 PAGE
3 Examination:
4 By Dr. Barden 5
5
Exhibits REFERRED TO
6
A -
Curriculum Vitae-Dr. Charles S. Schulz-2/17/04 25
7 B -
Curriculum Vitae-Dr. Charles S. Schulz-12/12/06 26
C -
July 2006 Department of Psychiatry Audit Report 56
8 D -
5/10/07 New York Times Article 60
E -
6/3/07 New York Times Article 61
9 F -
4/6-7/06 CME Schizophrenia Treatment Lecture 91
G -
8/3/05 AstraZeneca Results Update-David Brennan 108
10 H -
10/3/06 Washington Post Article 115
I -
9/22/05 New England Journal of Medicine Article 124
11 J -
9/06 University of Minnesota IRB Documents 127
K -
8/6/02 IRB Letter to Ophthalmology 175
12 L -
Financial Records of CAFE Study 201
M -
10/22/03 AstraZeneca Letter to Olson 204
13 N -
10/17/05 Listing and Check 207
O -
12/11 and 12/19/03 Theodore I Records 210
14 P -
Agenda for CAFE Web-Cast Meeting w/ Attachments 212
Q -
Remittance Papers and Attachments 226
15 R -
E-Mails and Other Correspondence 236
S -
Coordinator Call Minutes and Attachments 243
16 T -
CAFE Coordinator Teleconference Agenda and
Attachments 247
17 U - 11/7/03 Pallett E-Mail to Kenney with
Attachment 258
18
19 Requests made on pages 12 and 32.
20
21
22
23
24
25
4

1 P R O C E E D I N G S
2 DR. BARDEN: Well, I guess we'll go around
3 and introduce ourselves. My name is Dr. Chris Barden,
4 and I'm here on behalf of plaintiff Mary Weiss.
5 MS. PEARSON: I'm Gale Pearson here on
6 behalf of plaintiff Mary Weiss.
7 MR. RANDALL: Stephen Randall on behalf of
8 plaintiff Mary Weiss.
9 MS. WEISS: Mary Weiss, Dan Markingson's
10 mother.
11 MR. GROSS: Chuck Gross on behalf of the
12 University of Minnesota.
13 MS. AHMANN: Bridget Ahmann on behalf of
14 AstraZeneca.
15 MS. NELSON: Angela Nelson on behalf of
16 Dr. Schulz, Dr. Olson, and the University of Minnesota
17 Physicians.
18 MR. HUTCHINSON: David Hutchinson for the
19 University of Minnesota.
20 MS. FLYNN: Ruth Flynn, University of
21 Minnesota Physicians.
22 MR. ALSOP: David Alsop on behalf of
23 Dr. Schulz and Dr. Olson.
24 THE WITNESS: My name is Dr. Charles Schulz.
25 I'm head of the psychiatry at the University of
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1 Minnesota.
2 DR. BARDEN: Would you like to swear the
3 witness.
4 CHARLES SCHULZ, M.D.,
5 having been duly sworn, was examined and
6 testified as follows:
7 EXAMINATION
8 BY DR. BARDEN:
9 Q Good morning, Dr. Schulz.
10 A Good morning.
11 Q Have you ever been deposed before?
12 A Yes, I have.
13 Q How many times?
14 A I can't recollect for sure. I would say maybe ten times.
15 Q Have you ever been sued before?
16 A Yes, I have.
17 Q How many times?
18 A I recollect four times in my career.
19 Q And can you tell me the dates of those suits?
20 A I can give you an approximation of those --
21 Q Great.
22 A Of those suits.
23 Q That's fair.
24 A I was part of a suit brought around 1982 while I was on
25 the faculty at the Medical College of Virginia, and I was
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1 sued in about 1983 also while I was on the faculty there.
2 I was sued in I think about 1986 and in 1999.
3 Q Is the 1999 suit when you were at Minnesota or --
4 A No. I was -- well, I had arrived in Minnesota in July of
5 1999, but the suit related to a case while I was at
6 Case Western Reserve University.
7 Q Can you tell me the nature of the lawsuits?
8 A Yes, I can. The first lawsuit, I was on the faculty as
9 an inpatient attending psychiatrist at the
10 Medical College of Virginia on a locked ward. I was
11 taking care of a young man referred because he had not
12 been responding -- he had the diagnosis of schizophrenia
13 and his parents indicated he'd not been responding to
14 treatment. He was referred to our hospital, where he
15 underwent treatment for about a month and began to make
16 some improvement. I was still a consulting of the NIH
17 and went up to Washington from Virginia. The patient
18 remained in the hospital, and I think on a Friday, a
19 couple days after I left, and there had been a covering
20 psychiatrist as an attending, the patient was on what was
21 at that hospital known as a buddy pass, where people can
22 go out and walk around the hospital with another one of
23 the patients. He and this other patient went up to a
24 porch on the top floor of the hospital, and unfortunately
25 the buddy of my patient left my patient there, rather
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1 than staying with him, and my patient stacked up some
2 chairs and jumped off the top of the building.
3 Q Okay, so that was a suicide case.
4 A That was a suicide case.
5 Q What was the outcome of that case?
6 A Well, the outcome was that the hospital was sued, I was
7 an employee of the hospital, and there was the allegation
8 that the porch was not safe, that it should have had a
9 cover, not just a fence, and so the case was settled
10 between the plaintiffs, the hospital, and me.
11 Q Okay. What was the name of the case?
12 A I believe the patient's name was Krittenbrink.
13 Q Can you spell that for me, please?
14 A Again, I can approximate it, I think.
15 Q Sure.
16 A K-r-i-t-t-e-n-b-r-i-n-k.
17 Q Okay, and then the second lawsuit?
18 A The second case was a young man referred to the chair of
19 our department at the Medical College of Virginia. The
20 chair worked with the patient for awhile. Patient had
21 the diagnosis of schizophrenia, and because I had had
22 training at the National Institutes of Mental Health on
23 the schizophrenia ward, the chair asked if he could
24 transfer the patient to my team. We treated the patient
25 with antipsychotic medications with little result. Then
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1 he was given an augmenting medication, propranolol, and
2 improved substantially and was released from the hospital
3 and went to day treatment. Unfortunately, a week after
4 his discharge, he was in the shower, and appears to have
5 fainted while he was in the shower and, very
6 unfortunately, passed away. There was no evidence that
7 this was a suicide, but I was sued, and that suit was
8 settled.
9 Q Okay, so that was a wrongful death case.
10 A That's correct.
11 Q Involving a schizophrenic patient.
12 A Correct.
13 Q And the first one was a suicide case involving a
14 schizophrenic patient.
15 A That's correct.
16 Q How about the third lawsuit?
17 A The third lawsuit was of a woman whose father was
18 concerned about her lack of response. She had, I think,
19 was in her mid-30s, and had been poorly responsive and in
20 and out of state hospitals for approximately ten to 12
21 years, and she was brought to Medical College of
22 Virginia. She was treated with antipsychotics without
23 benefit, and the augmenting medication clozapine was
24 given, and the patient made some improvement, but did not
25 recover, and was transferred to the state hospital in our
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1 vicinity. A few weeks after, maybe six weeks after the
2 patient had been transferred, she developed bone marrow
3 depression, and despite a lot of extensive medical
4 treatment at the Medical College of Virginia, she died of
5 infection.
6 Q Okay. Was she a schizophrenic also?
7 A She was a schizophrenic, or schizoaffective person.
8 Q And the outcome of that suit?
9 A That was settled.
10 Q All right, and then you mentioned a fourth suit.
11 A Uh-huh. In the spring of 1999, a woman called to ask if
12 her son could participate in a brain imaging research
13 project with us, and he was evaluated, was not able to
14 participate in the study because of a past history of
15 substance abuse, or close enough to the brain imaging,
16 and continued care with his doctor. The patient's mother
17 called and said things were not going well with him and
18 that her son felt he wasn't making progress with his
19 psychiatrist. So they called urgently on a Monday, and I
20 saw them maybe the next day after hours, like at about
21 5:00 o'clock, to see what I could do; and after an hour
22 session of discussion, the case, etc., the patient, his
23 mother said it would really, really be nice if you could
24 work with our son. And I said, well, then, you know, I
25 would be, I would be willing to do that. Examined him,
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1 whether he was suicidal, whether he was feeling safe,
2 etc., and was assured he was going home to have dinner
3 with his family, etc. Unfortunately, what happened to
4 him was that he went home, he was a college student at
5 the time, had dinner with his family, and then said I'd
6 like to go over to my apartment, you know, at
7 Case Western. Went to his apartment and jumped out the
8 window.
9 Q Was he a schizophrenic also?
10 A He was a schizophrenic person also.
11 Q You mentioned the name of the first suit was the
12 Krittenbrink?
13 A Correct.
14 Q How about the second?
15 A I believe that case was Thomas Putnam, P-u-t-n-a-m.
16 Q And the third case?
17 A I believe her name was Brenda White.
18 Q And the fourth case?
19 A I'm sorry, I don't remember his name right off.
20 Q And the fourth case settled also?
21 A Well, the fourth case was tried, and I was acquitted.
22 Then the case was appealed, and the appellate court said
23 that I had testified and been qualified as an expert
24 during the trial, but because I had not been practicing a
25 certain number of hours, my expert testimony wouldn't
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1 count. So they directed the case back to the court, and
2 we settled for court costs, rather than retrying the
3 case.
4 Q Who was the lawyer in the fourth case? Just looking for
5 either the name of the plaintiff or --
6 A Yeah, I'm sorry, I don't remember the attorney's name.
7 It was eight years ago.
8 Q And you came to Minnesota in '99?
9 A I came to Minnesota in July of '99.
10 Q You mentioned you testified about ten times.
11 A Uh-huh.
12 Q I imagine you did in all four of these cases.
13 A That's correct.
14 Q What were the other six?
15 A Well, I have on occasion done expert witnessing or
16 consultation. I worked one case with the State of
17 Pennsylvania when I worked at the University of
18 Pittsburgh, providing assessment of a man who was in
19 prison. He had murdered his wife. He had suffered from
20 schizophrenia.
21 And then I've worked on about three other
22 cases involving post traumatic stress disorder in the
23 workplace.
24 Q Okay. Can you give me the names of those?
25 A I just -- I don't have the names of those where I served
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1 as expert witness.
2 Q Do you have access to those? You do have a list of
3 those?
4 A I don't have a list of those, but if it were something
5 that you need, I would work with Mr. Alsop and we could
6 track down the attorneys I worked with and get those
7 cases.
8 Q Great, thank you, that would be --
9 A I mean, I'd certainly do my best.
10 Q That would be very helpful. Thank you. So you've only
11 testified -- let me ask you this: Have you ever
12 testified for the plaintiff in a malpractice case?
13 A I'm trying to think. I do not believe I've testified for
14 a plaintiff in a malpractice case.
15 Q Have you ever testified for the defendant in a
16 malpractice case?
17 A Yes, I have.
18 Q And you could -- you would be able to find out when and
19 where that was?
20 A That was about 25 years ago. So I would do my best, is
21 all I can say.
22 Q Have you testified as an expert witness in the last ten
23 years?
24 A I have testified as an expert witness I believe in one
25 case since I've been here in Minnesota in the last eight
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1 years. That's the only one I recall in the last eight
2 years.
3 Q And where was that case, do you recall?
4 A That was a case of a psychiatrist who worked in the
5 Chicagoland area, and the patient was a young man with
6 schizophrenia, and he was living at home, and he was
7 having some difficulties in the home, as I recall. I
8 don't want to overspeculate on him. But in any case,
9 what ended up happening is he ran out of his house, ran
10 down the block, climbed a tree, and fell out of the tree,
11 and hurt his back, a back, broke his back. And so I
12 testified for the defense in that case. That's the only
13 case I remember working as an expert for the defense in a
14 malpractice suit --
15 Q Okay.
16 A -- since I've been here.
17 Q Have the other cases involved post --
18 A Post traumatic stress disorder.
19 Q -- traumatic stress disorder. All right. Since you have
20 this experience, you probably don't need this, but I'll
21 just run through the list of things, the rules that we
22 need to follow. I'm supposed to ask questions in a clear
23 and intelligible manner; and if not, you'll let me know
24 and I'll reask it. Fair enough?
25 A Fair enough.
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1 Q If you ever need to take a break, we can do that whenever
2 you'd like, but only after you've finished answering a
3 question. Fair enough?
4 A Uh-huh.
5 Q Your lawyer will make legal objections from time to time.
6 You need to make sure that he has the time to do that
7 clearly on the record, and then you can answer. Fair
8 enough?
9 A That sounds okay. I have talked to my attorney, and he's
10 indicated that --
11 MR. ALSOP: Just listen to the question. We
12 talked.
13 BY DR. BARDEN:
14 Q We can't both talk at once. It makes it very hard for
15 the reporter.
16 A I understand.
17 Q And we also can't speak too rapidly, so we'll work on
18 that. Fair enough?
19 A Okay.
20 Q Okay. Now, we're both going to be very careful not to
21 mention the names of any patients other than Dan, right?
22 A Fine.
23 Q And I'm also not going to ask you for any discussions
24 you've had with your lawyers. So even if it seems like
25 I'm asking you for the name of a patient or some
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1 discussion you've had with your lawyers, I'm really not.
2 I don't want that information. Fair enough?
3 A Fair.
4 Q What have you done to prepare for the deposition?
5 A I've had three meetings with my attorney, Mr. Alsop. I
6 have reviewed some materials that he's prepared for me.
7 I think that's about it.
8 Q Have you read the deposition of Dr. Olson?
9 A No, I have not.
10 Q Have you read the expert witness report from Dr. Harrison
11 Pope?
12 A I read a document by Dr. Pope regarding my participation
13 or my role in this case.
14 Q Okay. Have you read the expert witness affidavit from
15 Dr. Hudson?
16 A As it relates to me, yes.
17 Q Do you know Dr. Pope or Dr. Hudson?
18 A I know of their work, and I've seen Dr. Hudson at
19 meetings.
20 Q Okay. What's the -- in your field, what is the
21 reputation of Dr. Hudson and Dr. Harrison Pope?
22 MR. ALSOP: I'll object on the basis of
23 foundation. If you know, go ahead.
24 THE WITNESS: My area of work is relatively
25 specialized into schizophrenia, psychosis, other severe
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1 illnesses; and my understanding of the reputation of
2 Dr. Hudson, he works in the area of eating disorders and
3 other illnesses, and I think he has very good academic
4 reputation.
5 Dr. Pope has been writing and investigating
6 in the areas I treat, to my knowledge, for the last 30
7 years, publishes in respected journals, and is a
8 highly-regarded academician.
9 BY DR. BARDEN:
10 Q Have you ever spoken to Dr. Olson about this particular
11 case?
12 A Not since the meeting I had with him following the letter
13 I received from Mrs. Weiss, not since the lawsuit was
14 filed.
15 Q What was the nature of the discussion you had with
16 Dr. Olson at that time?
17 A I received a letter from Ms. Weiss in which she expressed
18 concerns about her son's participation in the CAFE study.
19 I wanted to make sure that these concerns were made known
20 to Dr. Olson, and I had a chance to talk with Dr. Olson
21 and one of the project coordinators, Ms. Kenney. So I
22 had the letter available, but asked the two of them to
23 come to my office and review the letter, hear their
24 thoughts and concerns on what was going on with the
25 patient, and our meeting lasted for approximately an
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1 hour.
2 Then I drafted a letter of response to
3 Mrs. Weiss. I gave the draft of the letter to Dr. Olson
4 so he could review it, make sure we were all on the same
5 page, and he knew what I was going to be sending back to
6 her, and I mailed the letter back to Mrs. Weiss. And I
7 did not have an opportunity to talk with Dr. Olson about
8 the case after that time.
9 Q How many letters did you receive from Mrs. Weiss?
10 A Well, I have one, and I realize there is some -- that
11 Mrs. Weiss has indicated there were more letters, but I
12 received a letter, I think in April.
13 MR. HUTCHINSON: Could I interrupt? Is it
14 Weiss or Weiss? It's Weiss, isn't it?
15 DR. BARDEN: It's Weiss.
16 MR. HUTCHINSON: It's Mrs. Weiss.
17 THE WITNESS: I apologize, Mrs. Weiss.
18 BY DR. BARDEN:
19 Q So to the best of your knowledge, you only remember
20 receiving one letter?
21 A That's correct, to the best of my knowledge, right.
22 Q And how many letters did Dr. Olson receive, do you know?
23 A I don't know.
24 Q During your hour-long discussion with Dr. Olson about
25 this case after Dan's death, what did you discuss in that
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1 one-hour meeting?
2 MR. ALSOP: That's a misstatement. This
3 hour-long meeting was before his death. It's the meeting
4 about the letter.
5 DR. BARDEN: But it was the meeting. Thank
6 you.
7 THE WITNESS: Well, I don't have the letters
8 available, but it was, I would say mid-April.
9 BY DR. BARDEN:
10 Q Was there documentation made of this meeting?
11 A Other than the draft of the letter that I mailed back to
12 Mrs. Weiss in response to her letter, describing what my
13 thoughts were and my attempt to address her points, that
14 was the only documentation made.
15 Q Okay, so you had a one-hour meeting with Dr. Olson.
16 A And --
17 Q And with Ms. Kenney.
18 A Uh-huh.
19 Q About patient care of Dan Markingson, but there was no
20 documentation made of this meeting, other than this
21 letter. Is that your testimony?
22 A Well, the person was in a research study and --
23 MR. ALSOP: Well, Doctor, the question is,
24 are there any other documentation you're aware of or not.
25 Do you know?
19

1 THE WITNESS: There is no other
2 documentation made.
3 BY DR. BARDEN:
4 Q Are you aware that Dr. Olson has testified that he was
5 also Dan's treating physician throughout this entire
6 time?
7 A I haven't seen his deposition. I don't know what he said
8 about it.
9 Q As the coinvestigator on the CAFE study, were you aware
10 that Dr. Olson was Dan's treating psychiatrist and his
11 only treating physician up until the day of his death?
12 A No.
13 Q So this is the first time that you've learned of that.
14 A I have -- I've been made aware of that after the lawsuit
15 has been filed.
16 Q Okay, and you've read Dr. Pope and Dr. Hudson's concerns
17 about having the treating, the only treating physician
18 and the only treating psychiatrist, also being the PI on
19 the study and also being the study psychiatrist for Dan,
20 and him filling all of those roles for Dan and their
21 expressing concern about that. You've read that,
22 correct?
23 A Yes, I have.
24 Q Do you share their concerns about those multiple roles
25 for Dr. Olson?
20

1 A No.
2 Q You don't.
3 A I don't.
4 Q Can you point to me any peer review journal articles or
5 references that would indicate that Dr. Olson's behavior
6 was acceptable, that is, being the only treating
7 physician, the only treating psychiatrist, the PI, and
8 the study physician for Dan?
9 MR. ALSOP: It's vague and ambiguous, but go
10 ahead.
11 THE WITNESS: No. Yeah, I'm not aware of a
12 peer review article that discusses that.
13 BY DR. BARDEN:
14 Q Are you aware of any publications of any kind that would,
15 that discuss that?
16 A No.
17 Q Have you yourself performed those multiple functions with
18 your patients that you've treated?
19 MR. ALSOP: That's irrelevant, but go ahead.
20 THE WITNESS: Well, I have not been the
21 principal investigator of a study for quite some time,
22 maybe one or two studies, but in the past, maybe ten, 12,
23 15 years ago, I've been principal investigator of a study
24 and the person who also was the only doctor for a patient
25 in the study.
21

1 BY DR. BARDEN:
2 Q Okay, so it's been -- so in the last 15 years, you have
3 not served those multiple roles with any of the patients
4 you've seen?
5 A No, just --
6 MR. ALSOP: That's a misstatement of his
7 testimony, it's argumentative, but go ahead, Doctor, you
8 can answer.
9 THE WITNESS: I just want to think a second
10 to make sure I'm reviewing in my mind the studies where
11 I've been principal investigator. I would like to say,
12 within the last eight years, I have always involved other
13 doctors in the studies, either as the rating psychiatrist
14 or somebody that would be available.
15 BY DR. BARDEN:
16 Q So for the last eight years, you've involved others.
17 A Correct.
18 Q How many patients have you treated in the last eight
19 years?
20 A Well, my major duty is administrative in the
21 Department of Psychiatry as the department head. What I
22 do clinically is each year, either for two to four weeks,
23 I will work as the attending psychiatrist on one of our
24 inpatient services, and I --
25 Q That's for two to four weeks per year?
22

1 A That's correct.
2 Q Okay.
3 A And so I will go over to our ward, meet the resident med
4 student. We will see anywhere from eight to ten
5 patients. It provides an opportunity for teaching,
6 supervision, and discussion, but I'm the attending
7 physician for those patients during that week I'm the
8 attending.
9 Q Just for two to four weeks a year.
10 A Right.
11 Q So for the rest of the year, you're not really seeing
12 patients?
13 A Well, I'm sorry, I hadn't finished.
14 Q Okay.
15 A But I appreciate that. So I also see people in the
16 outpatient clinic, and I have maybe six or seven patients
17 I work with regularly on an outpatient basis, and I'm
18 trying to think how to quantify this. Spend anywhere
19 from two to four hours a week in the outpatient clinic,
20 sometimes more, sometimes less.
21 Q So the number of hours over the course of a year per week
22 that you spend in patient care is quite minimal.
23 A Well, I've -- compared to what? I think compared to
24 other people at the University, that's a pretty good
25 clinical load for a department chair, and I think for a
23

1 person, compared to a person in full-time practice, it's
2 a small number.
3 Q What percentage of your time are you seeing actual
4 patients?
5 A I think I just described. I go to the wards two to four
6 weeks a year, and on the wards four weeks since January,
7 and I see outpatients in our clinic anywhere from one to
8 two to four hours a week.
9 Q Okay, so it's less than ten percent of your time.
10 A Well, I think I've given you the actual amount of time
11 I've spent.
12 Q But in terms of a percentage of your time, what would you
13 say, per patient, actual patient care where you're the
14 physician in charge of that patient, not where you're
15 supervising or you're watching other people treat?
16 A No, I understand. I think I try to understand what a
17 percentage is, is, you know, how much time I spend
18 working in a week. A 40-hour week, I would say I
19 probably spend somewhere between five and ten percent of
20 my time in direct patient care.
21 Q But you work a lot more than 40 hours a week, don't you?
22 A I do.
23 Q So it would be less than ten percent, certainly.
24 A I think I said five to ten percent.
25 Q Okay. Have you spoken to any representatives of the
24

1 AstraZeneca firm about this case?
2 A No.
3 Q You've had no conversations with anyone from AstraZeneca
4 at all about this case.
5 A No.
6 Q Have you talked to any other -- have you talked to anyone
7 else, outside of your attorneys, of course, about this
8 case, including medical colleagues?
9 A Uh-huh.
10 Q Pardon?
11 A Uh-huh. I've talked to one person. I was on the phone
12 with a colleague of mine, she and I are working on some
13 manuscripts together. She is on full-time faculty at
14 McLean Hospital. And at the end of the conversation, I
15 let her know that two of her fellow faculty people had
16 rendered the, their expert opinions, especially the part
17 about the chair's duties to monitor trials, and asked
18 her, is this how it goes at McLean Hospital. So I did
19 discuss it with that faculty person.
20 Q What was her name?
21 A Dr. Mary Zanarini.
22 Q Mary Zanarini.
23 A Uh-huh.
24 Q When did that conversation take place?
25 A Probably in the beginning of June.
25

1 Q June of this year.
2 A That's correct.
3 Q So just a few weeks ago.
4 A Correct, after I had received the expert opinions of
5 Drs. Pope and Hudson.
6 Q Okay. Have you talked to anyone else?
7 A Nope.
8 Q All right. I'll show you what we're going to mark as
9 Exhibit A.
10 (Schulz Deposition Exhibit A marked for
11 identification.)
12 BY DR. BARDEN:
13 Q Could you identify that for me.
14 A Okay. This is my curriculum vitae dated February 17,
15 2004.
16 Q Okay, and is that your signature there?
17 A Yes, it is.
18 Q It is. Okay. And you signed it 5-19-04, which gives us
19 the date of the most recent version, correct?
20 A I don't believe so. I think the signature there for
21 5-19-04 is the time that this was signed for some reason
22 or another, either participating in the study or
23 something like that.
24 Q Okay. Have you done an update of your vitae since 2004?
25 A Yes.
26

1 Q And could we get a copy of that?
2 A I'd be happy to work with you on that.
3 MR. ALSOP: You have a copy.
4 MS. PEARSON: We just got one this morning.
5 DR. BARDEN: Oh, we got one this morning.
6 MS. AHMANN: We have it.
7 MR. ALSOP: In the answers to
8 interrogatories you got this morning. This document was
9 served some time ago.
10 MS. PEARSON: We received some time ago.
11 DR. BARDEN: Why don't we mark this.
12 (Schulz Deposition Exhibit B marked for
13 identification.)
14 BY DR. BARDEN:
15 Q You went to medical school at UCLA, correct?
16 A Yes, I did.
17 Q Now, let me ask you a few questions. In 1988-89, you
18 were at the National Institute of Mental Health in
19 Rockville. Is that right?
20 A That's correct.
21 Q What, if any, financial relationships with drug companies
22 did you have during that timeframe?
23 A I think at that time I, on occasion, would give a lecture
24 that was sponsored by a drug company, but I had no
25 consulting relationship or any other relationship.
27

1 Q How many drug companies -- during the time Dan Markingson
2 was in your research study -- and let me back up just a
3 minute. You were a coinvestigator on the CAFE study,
4 correct?
5 A That's correct.
6 Q And you were listed as a ten percent, I believe, on that
7 study?
8 A I don't recall.
9 Q Would that be consistent with what you typically do in
10 research studies, you're a consultant, where you help out
11 with training or supervision or something like that?
12 MR. ALSOP: Object as speculative and vague.
13 Go ahead, you can answer.
14 THE WITNESS: It's hard for me to say what I
15 usually do, but in this case, what I remember planning on
16 doing was being a coinvestigator to be available if a
17 backup rater might have been needed or if Dr. Olson had
18 any questions that he wanted to chat with me about about
19 how the study went, and I don't recall exactly what the
20 amount of time I put down on my effort certification for
21 the study was.
22 BY DR. BARDEN:
23 Q Do you have records that show that?
24 A I believe we should, at the University, have records of
25 how much time we spend allocated to each study.
28

1 Q How much funding did you receive from CAFE study?
2 A I don't believe I received any.
3 Q So you were listed as ten percent, but you don't recall
4 receiving any funding.
5 A I think I said I don't recall how much time I was listed
6 on effort, but I don't believe I received any money from
7 the study towards my compensation.
8 Q But you were listed as a coinvestigator, correct?
9 A That's correct, I was.
10 Q And what are your duties and responsibilities as a
11 coinvestigator on the CAFE study?
12 A I think I just mentioned that I was available if a backup
13 rater was needed, and to be available to Dr. Olson to
14 discuss any issues that might come up with the study, and
15 my -- that was what my role in the study was.
16 Q Are there any other duties that you have as a
17 coinvestigator on a funded study, other than the ones
18 you've discussed so far?
19 A I think at the University of Minnesota, the other duty
20 would be to, if the principal investigator were not
21 available or if the investigator moved and the study
22 stayed at the University of Minnesota, to be available to
23 substitute as the principal investigator for the study
24 until it was done.
25 Q What, if any, duties do you have as a coinvestigator to
29

1 ensure that informed consent is properly obtained?
2 A I have not participated in verifying informed consent or
3 obtaining informed consent as a coinvestigator in studies
4 at the University of Minnesota.
5 DR. BARDEN: Objection, move to strike as
6 nonresponsive.
7 BY DR. BARDEN:
8 Q What, if any, duties do you have as a coinvestigator with
9 regard to obtaining proper informed consent?
10 A I do not have any duties as a coinvestigator regarding
11 informed consent.
12 Q What, if any, duties do you have as a coinvestigator to
13 ensure that the rights of research subjects are
14 protected?
15 MR. ALSOP: Object as vague, but go ahead.
16 THE WITNESS: I don't have any -- I'm not
17 aware that I have -- I do not have any specific duties.
18 BY DR. BARDEN:
19 Q In your resume, you list a number of research
20 publications, correct?
21 A Yes.
22 Q Have you ever published anything in any peer review
23 journal with regard to the rights of research subjects?
24 A If I could ask a clarification of the question. I have
25 written about informed consent. I don't know whether it
30

1 was in a refereed or nonrefereed journal article.
2 Q I show you what has been marked as Exhibit B, which is
3 your curriculum vitae that is updated. Can you find me
4 any article you believe focuses on the rights of research
5 subjects?
6 A Sure. Sorry that it's taking me a little bit of time to
7 find this. Well, in response to your question, I can't
8 find the reference to an article I wrote that I believe
9 was not refereed, that was published in the
10 Hastings Journal, which is a journal of bioethics, during
11 the late 1970s, in which at a time I was a clinical
12 associate at National Institute of Mental Health and I
13 wrote the article with my section chief,
14 Dr. Dan van Kammen, and the bioethical consultant to our
15 board, Dr. Fletcher.
16 Q Would you have a copy of this article or the reference
17 for it?
18 A I know it was in the Hastings Journal, and I know it was
19 in the late 1970s, and I apologize, it's not in my CV.
20 That kind of surprises me.
21 Q Do you have any reason why it wouldn't be listed in your
22 CV?
23 A No, uh-uh. I'm actually disappointed it's not there.
24 Q Have you written any article you can show me in your
25 updated vitae with regard to fiduciary duties of
31

1 physicians to their patients?
2 A I'm not aware I've written about that.
3 Q What's your understanding of the term fiduciary duties?
4 Strike that. Let me ask it a different way.
5 What's your understanding of the fiduciary
6 duties a physician owes to their patients?
7 MR. ALSOP: I'll object.
8 MR. HUTCHINSON: I'm just going to object,
9 and insofar as it may be asking this witness of legal
10 matters or legal conclusions.
11 MR. ALSOP: I'll join. It's also vague and
12 ambiguous. But go ahead, you can answer if you can.
13 THE WITNESS: Well, I don't want to sound
14 like I don't know my vocabulary words, but if you could
15 spell out for me what you mean by fiduciary, it will help
16 me.
17 BY DR. BARDEN:
18 Q Okay. Have you ever read any biomedical ethics texts?
19 A I can't recall.
20 Q Have you had any training at all in biomedical ethics?
21 A Yes, I have.
22 Q Have you had any training at all in the duties physicians
23 owe their patients?
24 A Well, I've gone to medical school and residency, and I've
25 been a fellow, so in that sense, yes.
32

1 Q What specific -- have you had any continuing medical
2 education courses in the ethical duties physicians owe to
3 their patients?
4 A I don't recall, no.
5 Q Pardon?
6 A I don't recall that I have.
7 Q You are required in the State of Minnesota to take
8 continuing medical education, correct?
9 A That's correct.
10 Q And you're also required to keep a list of the courses
11 that you take. Is that correct?
12 A That's correct.
13 Q Now, that list is not in the vitae, correct?
14 A That's correct.
15 Q Do you have access to that list?
16 A Yes, I do.
17 Q Where would that list be?
18 A That would be in my office, and to just answer the
19 question further, what I do is keep the certificates of
20 the CME activities I participate in.
21 Q Would you be able to get us a copy of those?
22 A Yes.
23 Q Thank you. So in your training, whatever training you've
24 had in biomedical ethics of the duties that physicians
25 owe to their patients, have you never seen the term
33

1 fiduciary duty?
2 A Well, I can't say whether I've heard it or not. I was
3 just hoping you could provide some further definition so
4 I could do my best to answer the question.
5 Q As the chairman of psychiatry at the University of
6 Minnesota Medical School, as you sit there now, what is
7 your understanding, and I'm not asking you for any legal
8 term at all, I'm asking you for the rights used in
9 medicine, what is your understanding as you sit there now
10 of the term a physician's fiduciary duty to patients?
11 MR. ALSOP: Object as vague and ambiguous.
12 Again, go ahead, Doctor, if you can answer.
13 THE WITNESS: You know, I would only be
14 speculating in trying to answer your question. I just --
15 I don't know.
16 BY DR. BARDEN:
17 Q Do you think it's important for a chairman of a
18 department at the University of Minnesota Medical School
19 to be knowledgeable about the rights of medical patients?
20 A Yes, I do.
21 Q Do you think it's appropriate for the chairman of a
22 department at the University of Minnesota Medical School
23 to be aware of basic terminology in biomedical ethics?
24 MR. ALSOP: Object as vague. Go ahead.
25 THE WITNESS: Could you restate the
34

1 question? Because I'm -- I'm sorry.
2 MR. ALSOP: Go ahead.
3 BY DR. BARDEN:
4 Q Do you think it's important for a chairman of a medical
5 department at the University of Minnesota Medical School
6 to understand basic terms in biomedical ethics?
7 A Yes, I do.
8 Q What training have you had with regard to obtaining
9 proper informed consent?
10 A I've had training over a number of years. I think the
11 beginning of my training in informed consent occurred
12 when I was a clinical associate at the National Institute
13 of Mental Health, and the section chief, Dr. van Kammen,
14 worked with all of the clinical associates about the
15 issues of going through informed consent and also making
16 an assessment of the ability of a person to consent.
17 After that time, I've been involved in
18 studies sponsored by industry and their startup meetings,
19 and they provide substantial training about the informed
20 consent process when they have their startup meetings.
21 And then at the University of Minnesota,
22 there are required courses in responsible conduct of
23 research, and I've attended those.
24 Q Now, throughout the course of the day, I'm never going to
25 ask you for a legal opinion on anything. Fair enough?
35

1 A Sounds fine.
2 Q But there are terms and concepts that are used in
3 medicine that are also used in law, correct?
4 MR. HUTCHINSON: Objection, lack of
5 foundational.
6 MR. ALSOP: I'll join.
7 THE WITNESS: I would guess so.
8 BY DR. BARDEN:
9 Q Let me give you an example. Informed consent, that's a
10 term that's used in medicine, isn't it?
11 A Yes, it is.
12 Q It's also used in law. But if I ask you for your opinion
13 or for information you know about a term informed
14 consent, I just want to clarify, I'm only asking you for
15 your medical knowledge. I'm not going to ask you how
16 it's used in the legal world. Is that okay?
17 A That's fine.
18 Q But as a licensed physician in the State of Minnesota,
19 you are required to know some legal things, aren't you?
20 MR. ALSOP: Object to foundation.
21 BY DR. BARDEN:
22 Q Such as the rights of patients with regard to informed
23 consent. Is that right?
24 MR. HUTCHINSON: That sounds like are you
25 asking him if he's required to know the legal rights, and
36

1 I understand from your prior preface that you're not
2 asking that.
3 BY DR. BARDEN:
4 Q I'm just going to make it clear. You're a licensed
5 physician in the State of Minnesota, correct?
6 A That's correct.
7 Q And as a licensed physician, you are required to know
8 certain things. Isn't that right?
9 MR. ALSOP: Object to lacking in foundation.
10 Go ahead.
11 THE WITNESS: I'll say yes.
12 BY DR. BARDEN:
13 Q Okay. As a licensed physician practicing in the State of
14 Minnesota, what is required of a physician in terms of
15 obtaining informed consent, what information are you
16 required to obtain from the patient and give to a
17 patient?
18 A The way I'd like --
19 MR. HUTCHINSON: Again, you're not asking
20 for the legal requirements, I understand.
21 DR. BARDEN: I think the question is clear
22 as it stands, uh-huh.
23 MR. HUTCHINSON: No, I disagree, but go
24 ahead, Doctor.
25 THE WITNESS: I think the best way that I
37

1 know how to answer the question is to describe what I do
2 at my work with the patients I work with. When patients
3 come into either our clinic or into our hospital, they
4 sign a form consenting to participate in research. Then
5 when I see the patient, I talk with the patient about my
6 assessment, and then I discuss with them a treatment plan
7 and treatment alternatives.
8 So, for example, if I were meeting with a
9 person who had schizophrenia and I thought that there was
10 a medicine, such as risperidone, that might be best for
11 them, I would also discuss with them there might be some
12 alternative medicines, I would describe the side effects,
13 and then I would talk with them about what they would
14 like to do, and then I would proceed with the plan.
15 BY DR. BARDEN:
16 Q Okay. Would you do anything else, other than what you've
17 described?
18 A I think the only other thing I know about our current
19 practice is on our inpatient service, when a person is --
20 when an antipsychotic medication is recommended, there is
21 a separate form in our hospital that we go through the
22 risks of antipsychotic medication treatment, and the
23 patient signs that.
24 Q And do you know if that form was ever obtained from Dan
25 Markingson?
38

1 A I don't know.
2 Q Have you reviewed the case records?
3 A No.
4 Q When you had your one-hour meeting with Dr. Olson and
5 Jean Kenney, you never looked at any of the records?
6 A No. I just met with them.
7 Q Did Dr. Olson ever inform you that he never obtained such
8 a document from Dan Markingson?
9 A No, he didn't.
10 Q Did Dr. Olson inform you in that hour meeting that Dan
11 Markingson was under a threat or stay of commitment when
12 he signed the informed consent form for the CAFE study?
13 A Well, you've used two terms there, one was threat of
14 commitment, the other is a stay of commitment, and so
15 maybe you could clarify which you'd want to talk about.
16 Q Are you aware of any difference between the threat of
17 commitment and the stay of commitment?
18 A I'm aware of what a stay of commitment is in Minnesota,
19 and I'm not aware there is a term in Minnesota threat of
20 commitment.
21 Q Okay. What's your understanding of a stay of commitment?
22 A My understanding of it is, is that a person can, in a
23 hypothetical example, I'm working with a patient on a
24 ward, the person would be able to leave the hospital and
25 be on a stay of commitment, and if things did not go in a
39

1 good direction for that person, they didn't participate
2 in their care, then they could be brought back to
3 hospital.
4 Q And what's the purpose of a stay of commitment?
5 A I think the stay of commitment is to have a mechanism to
6 be able to keep a person in treatment.
7 Q Yeah. It's to control the person, isn't it?
8 A No.
9 MR. ALSOP: That's argumentative and a
10 misstatement of his testimony. Wait, wait. Go ahead.
11 THE WITNESS: Pardon me?
12 MR. ALSOP: You can answer, Doctor.
13 BY DR. BARDEN:
14 Q As a physician who has worked with patients, what, if
15 any, coercive influence would you say there is from a
16 stay of commitment hanging over their head during their
17 care?
18 A None.
19 Q Are you aware of any peer review journal or article that
20 would support your statement?
21 A No.
22 Q Did Dr. Olson inform you that Dan Markingson was under a
23 stay of commitment during your hour-long meeting with
24 him?
25 A No, he didn't, to the best of my recollection.
40

1 Q Did Dr. Olson ever inform you that he was, A, going to
2 recommend that the court recommit or restay the
3 commitment for Dan Markingson, because he considered him
4 a danger to himself or others?
5 A No.
6 Q And at the same time, he was not going to reconsent him
7 to the study? Did he tell you that?
8 A I'm sorry. There were a lot of parts to that. I didn't
9 quite get it.
10 Q Yeah. Several weeks before Dan died, were you aware that
11 Dr. Olson was going to petition the court to recommit Dan
12 Markingson at the same time he was going to not reconsent
13 him for the study?
14 A I'm sorry, I'm still not quite following, especially the
15 not knowing the dates or other things like that.
16 Q Would you be concerned if a psychiatrist under your
17 supervision was telling a court that a person was
18 incompetent, and was telling the research agencies that a
19 person was competent at the same time? Would you be
20 concerned about that?
21 MR. ALSOP: Object as vague and ambiguous.
22 Go ahead, Doctor.
23 THE WITNESS: Are you asking that in a
24 hypothetical sense?
25
41

1 BY DR. BARDEN:
2 Q Well, that's what happened in this case. So, yeah, I'm
3 asking you --
4 A So you're asking a specific question.
5 MR. HUTCHINSON: Object to that as a
6 misstatement of the evidence and argumentative, and
7 object to the preface.
8 MR. ALSOP: I would join in those
9 objections.
10 BY DR. BARDEN:
11 Q The record speaks for itself. Let's do it generally
12 first. Have you had a psychiatrist --
13 A We're talking hypothetically, now.
14 Q Let's start with a hypothetical, yeah.
15 A Okay.
16 Q Psychiatrist is instructing a court that a person is not
17 competent to make decisions for themselves with regard to
18 finances, travel, freedom, etc., but at the same time,
19 they're keeping the person in a research study in which
20 they have to be able to give consent. Would you have
21 trouble, have any concerns, if you saw that behavior in a
22 psychiatrist under your supervision?
23 MR. ALSOP: Object as vague and ambiguous.
24 Go ahead, Doctor.
25 MR. HUTCHINSON: Object on grounds of lack
42

1 of foundation.
2 MS. AHMANN: Join.
3 THE WITNESS: You know, my best answer is I
4 would want to know more. I think in the, my
5 understanding, in the State of Minnesota, a committed
6 person still, if felt to understand a research study, may
7 participate in a research study.
8 So I do understand your question, and it
9 would cause me concern if I were to learn about the
10 scenario you described, but then there would be other
11 circumstances or I'd want to know more about the story of
12 how the person could stay in the study and be a committed
13 patient.
14 BY DR. BARDEN:
15 Q Are there special rules and principles at the
16 University of Minnesota with regard to research subjects
17 who are decisionally impaired?
18 MR. ALSOP: Object on the basis of
19 foundation. Go ahead.
20 MR. HUTCHINSON: Join.
21 BY DR. BARDEN:
22 Q Well, let me deal with your lawyer's objection. Do you
23 know what the term decisionally impaired means?
24 A Yes, because I also collaborate with people who work in
25 research with, clinical research with people with mild
43

1 cognitive impairment or Alzheimer's disease, and so there
2 are patients there who have poor memory, and so they
3 are -- I don't know whether the technical term is
4 decisionally impaired or vulnerable, but I know that
5 there are needs to make sure that such a patient is,
6 Alzheimer's patient is, say the family would be involved,
7 etc., before a person would be involved in the study.
8 Q How about psychotic patients?
9 A Psychotic patients, my understanding is that there is an
10 obligation to understand whether the person understands
11 the study they are participating in, can answer questions
12 about what the study is about, what some of the side
13 effects of the medication are, what the point of the
14 study is, etc.
15 Q Okay. Going back to your lawyer's objection again, are
16 you aware of the IRB rules and requirements and
17 guidelines for the University of Minnesota?
18 A I think I'm -- I'm aware of those, sure.
19 Q Now, given that you're aware of the term decisionally
20 impaired and given that you're aware of the term, of the
21 guidelines of IRB, what are, as you sit there now, what
22 are the guidelines for the IRB at the University of
23 Minnesota with regard to a decisionally impaired subject?
24 A Well, I think, first of all, there is a decision as an
25 investigator goes through the IRB process, whether or not
44

1 the subjects who are being involved in the protocol are
2 vulnerable, and if that is determined that they may be,
3 that there may be subjects there, then there needs to be
4 a plan about how to obtain consent.
5 So if we're talking generally, then, for
6 example, if we had a person under the age of 18, we would
7 want to obtain the consent of the parents and the assent
8 of the subject.
9 Q Anything else?
10 A No.
11 Q Is there any other system in place for vulnerable
12 subjects, any other steps that are supposed to be taken?
13 A My understanding of the rules about vulnerable, possibly
14 vulnerable people, is that the investigator is to work
15 with the IRB to make a plan that is specific to his
16 protocol.
17 Q If a psychiatrist, treating psychiatrist, and a treatment
18 team and an outside evaluator had all determined that a
19 patient lacked capacity, was grossly psychotic, was not
20 aware that he was mentally ill, and felt that he didn't
21 need treatment, and petitioned a court for commitment,
22 would that person be a vulnerable research subject within
23 the guidelines of the IRB at the University of Minnesota?
24 A Without knowing more about the specific case, I can't
25 answer that.
45

1 Q Based on what I've told you so far, you don't --
2 A Not necessarily.
3 Q Okay. Would you be concerned that a patient that had had
4 that many evaluations, finding them lacking capacity,
5 finding them grossly psychotic, finding them not aware
6 that they were mentally ill, and finding them not
7 interested in treatment, would you be concerned if that
8 patient had not been evaluated as a potential vulnerable
9 subject?
10 MR. ALSOP: That's repetitious, it's vague
11 and ambiguous. Go ahead, Doctor.
12 MR. HUTCHINSON: I join. Lack of
13 foundation.
14 THE WITNESS: I'm sorry to have to say that
15 I'm still confused about the question, whether we're
16 talking about this in a hypothetical sense or whether
17 we're talking about it, about a specific circumstance,
18 say with this person, with Dan.
19 BY DR. BARDEN:
20 Q Well, right now we're talking about a hypothetical.
21 A Given the hypothetical, then I think that there may be
22 some other information I would want to learn about the
23 patient; and if the patient were, despite some of the
24 aspects of the seriousness of the illness, have
25 understanding of the research process, the research
46

1 protocol, and wished to participate in it, I would not
2 view him as necessarily incompetent to consent.
3 Q But you didn't read the records for Dan Markingson,
4 correct?
5 A Correct.
6 Q And in your one-hour meeting with Dr. Olson, he didn't
7 inform you that he and the treatment team and the outside
8 evaluator had all found Dan Markingson, within days of
9 when he signed the informed consent in this study, to
10 lack capacity, to be grossly psychotic, to not think he
11 was mentally ill at all? Dr. Olson didn't inform you of
12 that, did he?
13 A No, he didn't.
14 Q Do you have methods and procedures in place in the
15 Department of Psychiatry to catch rogue psychiatrists?
16 MR. ALSOP: I object as vague and ambiguous
17 and irrelevant, but go ahead.
18 MR. HUTCHINSON: Same. Lack of foundation.
19 THE WITNESS: So the quality assurance
20 processes at the University of Minnesota and the
21 University of Minnesota Medical Center at Fairview are
22 that on every inpatient service--and let me put a time
23 limit on this, because in the last year, it's been
24 changed to electronic, but that's not relevant to the
25 timeframe we're talking about--that there are forms on
47

1 every ward, and that the staff on the ward, any staff,
2 can write a complaint of concern about any physician's
3 activities, and then that is sent to the administration
4 of the hospital; and then that, after it's reviewed by
5 the administrative staff, may be referred back to the
6 unit to be discussed between medical director and person
7 who was complained about, or if it was an issue of a
8 difference of opinion about a treatment approach between
9 say a staff nurse and a patient, that it would be
10 discussed on the unit. Or, in rare cases, it would be
11 referred to a University of Minnesota Medical Center
12 quality committee.
13 BY DR. BARDEN:
14 Q Was this system in place during the time Dan was treated?
15 A Yes.
16 Q Have you -- let me go back to the rogue psychiatrist
17 question first. Have you had trouble in the past at the
18 University of Minnesota Psychiatry Department with
19 someone considered rogue psychiatrists?
20 MR. ALSOP: Same objection, it's irrelevant,
21 but go ahead.
22 MR. HUTCHINSON: Objection, lack of
23 foundation.
24 MS. AHMANN: Join.
25 THE WITNESS: I've been at the University of
48

1 Minnesota for eight years, and I'm not aware of any.
2 First of all, I have to preface my remark. I don't know
3 what the definition of rogue psychiatrist is.
4 BY DR. BARDEN:
5 Q Okay. Let me give you one. A psychiatrist who's been
6 prosecuted and found guilty of criminal activity. That
7 would be a rogue psychiatrist, wouldn't it?
8 MR. HUTCHINSON: Well, you're the one using
9 the term rogue. Is that how you want to define it,
10 counsel?
11 BY DR. BARDEN:
12 Q Have you never heard the term rogue psychiatrist?
13 A No.
14 Q Okay. Well, let me say criminals or people who violate
15 the ethics code or people who have their licenses
16 suspended. Is there a history of that at the
17 University of Minnesota Psychiatry Department?
18 MR. HUTCHINSON: Same objection.
19 MR. ALSOP: I join, foundation, but go
20 ahead, Doctor.
21 THE WITNESS: I am aware of that, of two
22 instances prior to my coming to the University of
23 Minnesota, where proceedings were brought against a
24 psychiatrist, Dr. Garfinkel, and I am not -- that was
25 well before I got here, but I am aware that charges were
49

1 brought against him and that those were sustained; and I
2 know that he is not working at the University now and
3 works in private practice here in the Twin Cities.
4 BY DR. BARDEN:
5 Q Do you know what the charges were while he was a faculty
6 member in the Department of Psychiatry?
7 A I don't.
8 Q You don't.
9 A No.
10 Q Were they criminal in nature, do you know that?
11 A I don't know that one way or the other.
12 Q How about Dr. Abuzzahab? Have you ever heard that name?
13 A Yes, I have heard of Dr. Abuzzahab.
14 Q Do you know of any unethical behavior, misconduct,
15 license revocations, with regard to Dr. Abuzzahab?
16 MR. ALSOP: Object on the basis of
17 relevance. He wasn't at UM-DP, but go ahead.
18 DR. BARDEN: Goes to show a pattern of
19 conduct.
20 THE WITNESS: When I arrived here at the
21 Department of Psychiatry, the department administrator
22 informed me that Dr. Abuzzahab, who was in private
23 practice and not a member of the Department of Psychiatry
24 at the time, although I think he may have been on
25 volunteer, so-called adjunct or a volunteer faculty, had
50

1 had, I'll just use the word difficulties, because I don't
2 know how to -- I don't know more of the specifics. Had
3 had difficulties with the state board.
4 BY DR. BARDEN:
5 Q Do you think your characterization of Dr. Abuzzahab's
6 troubles as difficulties is misleading?
7 A No.
8 MR. ALSOP: That's argumentative.
9 BY DR. BARDEN:
10 Q Do you know any more detail about Dr. Abuzzahab's case
11 than what you've discussed so far?
12 A I'd have to say everything else is really just hearsay.
13 I don't have any -- I mean, I realize there was an
14 article about him in the New York Times during the last
15 month that I read, but any other thing about
16 Dr. Abuzzahab that I know is, you know, somebody in the
17 hallway said Dr. Abuzzahab had trouble with this or with
18 that.
19 Q Well, it was reported that his license was suspended,
20 correct?
21 A Yes, that's correct.
22 Q And given that his license was suspended, what steps did
23 you take to investigate why his license was suspended?
24 MR. HUTCHINSON: Well --
25 MR. ALSOP: I'll object as irrelevant,
51

1 misstatement of the facts, but go ahead, Doctor.
2 MR. HUTCHINSON: And totally lacking in
3 foundation. There has been no showing of any
4 relationship between this witness and Dr. Abuzzahab that
5 imposes some obligation on this witness to do anything.
6 BY DR. BARDEN:
7 Q I think that's a fair objection. Let's make it really
8 relevant. During your tenure as chairman, Dr. Abuzzahab
9 has been invited back on the faculty. Isn't that
10 correct?
11 A During the time that I've been -- when I arrived here at
12 the Department of Psychiatry, Dr. Abuzzahab had already
13 had an appointment as a volunteer faculty member. He has
14 not been on the full-time faculty since my arrival.
15 Q But he is still currently on your faculty, correct?
16 A Well, I want to make clear that we have different faculty
17 appointments at the University of Minnesota, one of those
18 being clinical or adjunct professor for people in private
19 practice who may do things with the department, and what
20 Dr. Abuzzahab has done in his role as a clinical faculty
21 member has mostly been in the area of continuing medical
22 education.
23 Q Okay, and if you go to the University of Minnesota
24 website for the Department of Psychiatry, you see him
25 listed as a faculty member, correct?
52

1 A I haven't looked at that lately, but I think I've said he
2 is on our adjunct faculty.
3 Q Okay, and since he's on your adjunct faculty, if he can
4 claim this University of Minnesota label, what steps, if
5 any, did you take to investigate the reasons why his
6 license was suspended?
7 MR. ALSOP: Object on the basis of
8 relevancy, but go ahead, Doctor.
9 MR. HUTCHINSON: Join.
10 THE WITNESS: You know, I think -- I realize
11 there are rules about when we can take a break and not
12 take a break. Can we take a break now or --
13 MR. ALSOP: First, you can answer that
14 question first.
15 BY DR. BARDEN:
16 Q You can take a break whenever you like.
17 A Okay.
18 Q But only after you finish answering a pending question.
19 A I understand. Could you repeat the question for me?
20 Q Yeah. You're the chairman of psychiatry, right?
21 A I am, that's correct.
22 Q You do have a duty to get unethical people or people who
23 are reckless or dangerous, to keep them off your faculty,
24 correct?
25 MR. HUTCHINSON: Well, now we're going
53

1 beyond -- he wanted to take the break, and now we're
2 asking additional questions.
3 MR. ALSOP: Just answer the question that he
4 asked.
5 THE WITNESS: I'm sorry, I don't know what
6 that question was.
7 BY DR. BARDEN:
8 Q What steps, if any, did you take to investigate why
9 Dr. Abuzzahab had his license suspended?
10 MR. ALSOP: Object on the basis of
11 relevancy. Go ahead and answer, Doctor.
12 THE WITNESS: The steps I took were to talk
13 to faculty who had been in the department prior to my
14 arrival about their understanding and work with
15 Dr. Abuzzahab. I recollect seeing material from the
16 State regarding that his license had been suspended, and
17 then I met with Dr. Abuzzahab. I relieved him of his
18 position he had before I arrived, that he held, which was
19 head of the clinical faculty committee, and replaced him
20 with Dr. Gaylen Staylen.
21 MR. ALSOP: Okay.
22 DR. BARDEN: I think we offered you a break.
23 THE WITNESS: Thank you.
24 DR. BARDEN: We'll pick this up when we come
25 back. Five minutes, ten minutes?
54

1 MR. ALSOP: Five minutes is fine.
2 (Brief recess taken.)
3 DR. BARDEN: We're back on the record.
4 BY DR. BARDEN:
5 Q Dr. Schulz, a little while ago you told us about your
6 system at the University for reporting complaints. Do
7 you recall that?
8 A For University of Minnesota Medical Center at
9 Fairview Hospital.
10 Q Uh-huh. You seemed pretty pleased with that program.
11 A Uh-huh, I did. I am.
12 Q Do you think your testimony on that issue was misleading?
13 A No.
14 MR. ALSOP: It's argumentative. Go ahead.
15 BY DR. BARDEN:
16 Q Have you in fact had trouble with your complaint system
17 at the University of Minnesota Department of Psychiatry?
18 MR. HUTCHINSON: When?
19 MR. ALSOP: Vague and ambiguous. Go ahead.
20 BY DR. BARDEN:
21 Q During the time Dan Markingson was treated --
22 MR. ALSOP: Same objections.
23 BY DR. BARDEN:
24 Q -- did you have serious problems with the way complaints
25 were handled and filed at the Department of Psychiatry at
55

1 the University of Minnesota?
2 A Not that I'm aware of.
3 Q Have you ever been audited?
4 A Have I ever been audited.
5 Q Has the Department of Psychiatry ever been audited?
6 A Oh, I'm sorry. Yeah, University of Minnesota provides
7 for audits of all departments on a regular basis every
8 seven to ten years, and we completed our audit I think
9 about a year and-a-half ago.
10 Q And they interviewed people, almost all of whom worked at
11 the Department of Psychiatry during the time Dan
12 Markingson was treated and was a patient and was a
13 research subject there, correct?
14 A I'm not sure I know all that they did, and they made a
15 report, so if I could refer -- I'd be happy to refer to
16 the report and talk with --
17 Q The University did?
18 A Yeah, the University's audit report.
19 Q The University audited your department, correct?
20 A Uh-huh, that's correct.
21 Q One of the things they did was to interview your
22 employees and staff and faculty members. Isn't that
23 correct?
24 A I believe so, yes.
25 Q And the vast majority, in fact, almost all of those
56

1 people, worked in your department during the time Dan
2 Markingson was a research subject and a patient there.
3 Isn't that correct?
4 MR. ALSOP: Object on the basis of
5 foundation, it's also vague. Go ahead, Doctor.
6 MR. HUTCHINSON: Join.
7 THE WITNESS: I would say that that's
8 approximately true, that a substantial number of people
9 that were working in the department in 2004 who
10 participated in the audit.
11 BY DR. BARDEN:
12 Q I show you what we're going to mark as Exhibit C.
13 (Schulz Deposition Exhibit C marked for
14 identification.)
15 BY DR. BARDEN:
16 Q If you could take a look at that and identify it for the
17 record?
18 MR. ALSOP: Do you have copies?
19 MR. HUTCHINSON: Excuse me. Do you have
20 copies for --
21 MR. ALSOP: Everyone.
22 DR. BARDEN: I think I have a couple.
23 Here's one. Yeah, I think that's all I have right now.
24 MR. ALSOP: Why don't we --
25 MS. PEARSON: We produced those.
57

1 DR. BARDEN: We're only going to look at it
2 for about two minutes.
3 MR. ALSOP: Why don't you wait until we get
4 copies.
5 MS. AHMANN: Is that the July 2006?
6 MR. ALSOP: Just go off the record for a
7 second.
8 DR. BARDEN: Going to go off the record, and
9 stop the clock. Thank you.
10 (Brief time off the record.)
11 DR. BARDEN: We're now back on the record.
12 For the record, we've just stopped for a long time to
13 make copies of these documents. For the future, to keep
14 this moving along, and so we can finish today, if
15 possible, if we have produced these documents to you,
16 we're just going to go ahead. If you want to look over
17 my shoulder or the doctor's, that's fine. But we have a
18 large number of documents, I don't know which ones we're
19 going to use or not, because it all depends on the
20 doctor's answers to many questions. We couldn't bring a
21 20-foot stack of documents to hand all out. All of these
22 documents have already been disclosed to you, so we're
23 just going to move forward.
24 MR. ALSOP: These were e-mailed, I saw, this
25 morning, apparently. I hadn't downloaded them yet, and
58

1 to say they were produced and we can have copies is not
2 an accurate statement.
3 DR. BARDEN: Well, we're just going to move
4 forward, because it's easier. The time to take to do
5 this is simply too long.
6 BY DR. BARDEN:
7 Q Doctor, could you identify what's been marked as
8 Exhibit C for the record, please.
9 A This is an audit report of the Department of Psychiatry
10 at the University of Minnesota.
11 Q Okay, and have you read this document before?
12 A Yes, I have.
13 Q And you've written about it, haven't you, you've written
14 letters back and forth to these folks who did the audit?
15 A I have talked with them and I have, pretty sure I have
16 given some written communication back and forth, yes.
17 Q Okay, so you were certainly aware of this audit of your
18 department, correct?
19 A Yes.
20 Q How many times has your department been audited in the
21 last four years?
22 A Once. It's been audited once in the last eight years.
23 Q So then you're certainly quite aware of this audit?
24 A Yes.
25 Q Okay, so during the time you were telling us about the
59

1 wonderful complaint procedures that you have, you were
2 aware of page 11 of this audit report that indicates --
3 in fact, look at the top of page 11. It says, quote,
4 "Additionally, the following issue received a --"
5 A I'm sorry, let me --
6 Q Page 11 at the top.
7 A Just want to make sure I'm with you.
8 Q "The following issue received a high negative response on
9 all three surveys. 41% of the Staff employees, 33% of
10 the Residents, and 71% of the Faculty said they were
11 unfamiliar with how to report violations of law or
12 policy, including the University's confidential reporting
13 line." Did I read that correctly, yes or no?
14 A Yes.
15 Q And you had read this document before you gave us your
16 testimony about the reporting system at the U, correct?
17 A Yes, I did.
18 Q Now, we look at the top of page 11 here, where it says,
19 "39% of the Staff did not believe that they would be
20 protected from retaliation if they were to report a
21 suspected violation." Did I read that correctly, at the
22 top of page 11?
23 A Yes, you did.
24 Q And were you aware of that when you testified here just a
25 few minutes ago?
60

1 A Yes, I was.
2 Q Now, we were talking about Dr. Abuzzahab, correct?
3 A Yes.
4 Q And Dr. Garfinkel, and you'd mentioned they'd had some
5 difficulties, correct?
6 A That's correct.
7 Q Yeah. Didn't Dr. Garfinkel, in fact, wasn't he convicted
8 of multiple felonies?
9 A I don't know.
10 Q I show you what we're going to mark as Exhibit No. D. I
11 do have copies of this.
12 MS. PEARSON: Dave, there is copies for you.
13 MR. ALSOP: Yeah, I'm passing it out.
14 (Schulz Deposition Exhibit D marked for
15 identification.)
16 BY DR. BARDEN:
17 Q This is a New York Times article dated June 3, 2007. The
18 title is "After Sanctions, Doctors Get Drug Company Pay."
19 Have you read this, Dr. Schulz?
20 A Uh-huh.
21 Q It begins by saying, "A decade ago the Minnesota Board of
22 Medical Practice accused Dr. --"
23 A I'm sorry, where are you reading from?
24 Q From the very first sentence.
25 A Mine says, "When Anya" is my first sentence.
61

1 DR. BARDEN: Okay. We're going to make this
2 Exhibit No. E.
3 MR. HUTCHINSON: Are we using numbers or
4 letters?
5 DR. BARDEN: We're using letters. And then
6 we'll come back to D.
7 (Schulz Deposition Exhibit E marked for
8 identification.)
9 BY DR. BARDEN:
10 Q Okay. Do you see at the top where it says, "After
11 Sanctions, Doctors Get Drug Company Pay?"
12 A Yes.
13 Q June 3, 2007, New York Times, correct?
14 A I do.
15 Q Have you read this article before?
16 A I have.
17 Q Okay. Looking at the first sentence, "A decade ago the
18 Minnesota Board of Medical Practice accused Dr. Faruk
19 Abuzzahab of a," quote, "'reckless, if not willful,
20 disregard,'" unquote, "for the welfare of 46 patients, 5
21 of whom died in his care or shortly afterward. The board
22 suspended his license for seven months and restricted it
23 for two years after that." Did I read that right?
24 A Yes, you did.
25 Q Okay. What percentage of physicians in Minnesota have
62

1 their license suspended, do you know?
2 A No.
3 Q Do you have any idea at all?
4 A No.
5 Q It is an extraordinarily rare occurrence, isn't it,
6 Doctor?
7 MR. ALSOP: Object as speculative, lacking
8 in foundation. Don't speculate. He said twice he
9 doesn't know.
10 THE WITNESS: I don't know.
11 BY DR. BARDEN:
12 Q Now, looking down farther down the page, it says, "In its
13 disciplinary action against Dr. Abuzzahab." Have you
14 read the state board's disciplinary action report?
15 MR. ALSOP: You can answer that question,
16 Doctor.
17 THE WITNESS: No.
18 BY DR. BARDEN:
19 Q You didn't think that would be an important thing to do,
20 to -- you have a person on your clinical faculty who's
21 had a license suspended, but you did not read the state
22 board of licensing's report on him, correct?
23 MR. ALSOP: Object as argumentative.
24 MR. HUTCHINSON: This is the report from
25 1997?
63

1 BY DR. BARDEN:
2 Q The report of the state board of medical licensing that
3 suspended Dr. Abuzzahab's license. Have you read that
4 report?
5 A No. Oh, but, and the date of that was? You asked me if
6 I read the report. When was that?
7 Q Correct. And I get to ask the questions, fortunately.
8 MR. HUTCHINSON: Well, the first line says
9 ten years ago. A decade ago.
10 DR. BARDEN: Yes, that is correct.
11 MR. HUTCHINSON: Which would be 1997.
12 That's how I understand it.
13 DR. BARDEN: I believe that is the date.
14 BY DR. BARDEN:
15 Q It says further down, "Dr. Abuzzahab failed to appreciate
16 the risks of taking Patient No. 46 off Clozaril, failed
17 to respond appropriately to the patient's rapid
18 deterioration and virtually ignored this patient's
19 suicidality." Do you see that?
20 A Yes, I do.
21 Q That's remarkably similar to the accusations against
22 Dr. Olson in this case, right? Isn't that correct?
23 MR. ALSOP: Object as argumentative, a
24 misstatement.
25
64

1 BY DR. BARDEN:
2 Q He failed to respond appropriately to the patient's
3 deterioration and virtually ignored the patient's
4 suicidality. Aren't those the allegations in this --
5 MR. ALSOP: Object as argumentative.
6 MR. HUTCHINSON: I'll join.
7 MR. ALSOP: If you know, Doctor, go ahead.
8 THE WITNESS: Just to be clear, the
9 question, you're asking me about the allegations against
10 Dr. Olson, compared to these findings by the board ten
11 years ago.
12 BY DR. BARDEN:
13 Q Right. We're in the early process --
14 A Uh-huh.
15 Q -- of this legal litigation with regard to Dr. Olson's
16 conduct, correct?
17 A Right, right.
18 Q Yeah, but you've read Dr. Hudson and Dr. Pope's opinions,
19 right?
20 A Uh-huh.
21 Q Isn't this true, that --
22 A What I said is I read their opinions as it related to me.
23 I did not read their opinions as it related to Dr. Olson.
24 Q But in their, in their opinions which related to you,
25 they certainly clearly stated that it was their opinion
65

1 Dr. Olson failed to respond to Dan's deterioration and
2 virtually ignored his suicidality, correct?
3 A I can't recall.
4 Q How long ago did you read those?
5 A I believe they arrived in the end of May.
6 Q "The Times's examination of Minnesota's trove of records
7 on drug company payments to doctors found that from '97
8 to 2005, at least 103 doctors who had been disciplined or
9 criticized by the state medical board received a total of
10 $1.7 million from drug makers."
11 A Where is that?
12 Q "The median payment over that period was $1,250; the
13 largest was $479,000." And you've read this before,
14 correct?
15 A Where are you reading from?
16 Q Page 2, at the top. Now, Doctor, Dr. Schulz, during the
17 time you've been at Minnesota from '99 to the present --
18 let's do it this way:
19 From '99 through the time that Dan
20 Markingson was a subject in the CAFE study, that is,
21 through 2004, how much money have you received from drug
22 firms?
23 A I --
24 MR. ALSOP: Object to --
25
66

1 BY DR. BARDEN:
2 Q I'm talking from all sources.
3 MR. ALSOP: It's irrelevant and vague, but
4 go ahead, Doctor. It's also lacking in foundation.
5 THE WITNESS: I can only make an estimate.
6 I believe that some years, from all sources, or putting
7 together work for different companies, some years -- I
8 want to make one more qualification. If I am asked to
9 give a lecture for a drug company, I will receive money
10 for the honorarium to give the talk, and then I will
11 receive money for my expenses to fly to the site and stay
12 in a hotel, eat dinner.
13 BY DR. BARDEN:
14 Q I'm interested in all of that, all of those files, all
15 totalled.
16 A I can't estimate all of that, but I would say that some
17 years I have made $20,000 and some years I may have made
18 $50,000 or $60,000, for professional services and
19 expenses.
20 Q So over a five-year period, you'd estimate that of, what,
21 a quarter million dollars, more, less?
22 A It has to be less, if some years are 20,000 and other
23 years are higher. Maybe 150,000, 180,000 dollars, in
24 total.
25 Q And that's from all drug companies from all sources, and
67

1 that includes being an investigator on research studies,
2 speaker, honorarium, consultant, travel expenses
3 reimbursed, and everything else, correct?
4 A No. I appreciate your clarifying that. What I was
5 responding to was money I had received to give a lecture
6 or to consult, but I have been the principal investigator
7 of two studies recently by Eli Lilly.
8 MR. ALSOP: I think he asked up until 2004.
9 THE WITNESS: Oh, okay. I think the point
10 that I'm trying to make is to clarify my response to you
11 about money received, and that my answer to you was based
12 on describing to you money I'd received to give a lecture
13 or for the expenses to get back and forth from the
14 lecture.
15 I have also been the medical director of
16 some of the department's CME meetings, and we have
17 received unrestricted educational support from
18 pharmaceutical companies to support these meetings, and
19 I'm aware on these databases that you have been talking
20 about that on occasion they will list that as money I
21 have received, when it's essentially gone straight to the
22 CME office.
23 DR. BARDEN: Objection, move to strike those
24 parts that are nonresponsive.
25
68

1 BY DR. BARDEN:
2 Q Looking for the dollar amount from any drug company, any
3 time, any kind of funding of any type sourcing from any
4 pharmaceutical company and ending up at you, and let's
5 start from 1999 through 2004, looking for a dollar
6 amount. And we don't really, we don't need to estimate
7 this eventually, because you do file income taxes. Is
8 that correct, Doctor?
9 A That's correct.
10 Q And you do report this as income, correct?
11 A Uh-huh.
12 Q And so, for example, if you're reimbursed for a trip to
13 Hawaii for a week, you do report that travel ticket as
14 income, do you not?
15 A I'm not -- the question was sort of long. I'm not quite
16 understanding the question.
17 Q Okay. If you receive a ticket to Hawaii from a drug
18 company to do a talk, you do report that to the IRS as
19 income, correct?
20 A I haven't been to Hawaii, but wherever I might get the
21 talk, if the company sent me a check for my honoraria and
22 for the expenses, yes, I would report that.
23 Q What if they just gave you a plane ticket, do they ever
24 do that, send --
25 A Sometimes they do.
69

1 Q Do you ever report that?
2 A I don't report that.
3 Q So we're looking for a dollar amount, '99 to 2004.
4 A You know, but given the parameters that you've put, and I
5 just, I can only make the estimate that I answered
6 before. That for speaking engagements and the expenses
7 for those speaking engagements, my estimate is that --
8 for the beginning of 1999 through the end of the fiscal,
9 academic fiscal year 2004, June 2004?
10 Q Uh-huh.
11 A Five years? I would say maybe 180,000.
12 Q $180,000. And that's in addition to whatever salaries or
13 clinical fees you're getting. Okay.
14 A I don't receive clinical fees above and beyond my salary.
15 Q Okay, so this is above and beyond your salary, correct?
16 A Correct.
17 Q $180,000 over that five-year period?
18 A For five years.
19 Q Above and beyond your salary?
20 A That's correct.
21 Q Let's say all the way from medical school to today, how
22 much money have you received from drug companies?
23 MR. ALSOP: Lacking in foundation,
24 irrelevant, but go ahead, Doctor. Also speculative.
25 THE WITNESS: The reason I'm pausing is that
70

1 I really have no idea how to estimate the amount of money
2 from medical school, I graduated 35 years ago, of how
3 much money I may have received from companies.
4 BY DR. BARDEN:
5 Q Could easily be a million dollars, though, right?
6 A I have no idea.
7 MR. ALSOP: Object to speculative.
8 BY DR. BARDEN:
9 Q You have no idea.
10 A I have no idea if it's near a million dollars or not.
11 Q Is it going up over the -- I mean, has it gone up since
12 2004? Are you receiving more now than you did then?
13 A Not in the last year, no. As a matter of fact, it's gone
14 down the last year.
15 Q How much has it been from 2004 till currently?
16 MR. ALSOP: Object on the basis of
17 relevancy, but go ahead, Doctor.
18 BY DR. BARDEN:
19 Q And again, this is all reported on your income taxes,
20 right?
21 A Uh-huh, I understand. I think that it may have been as
22 high as $72,000 in 2005, and 2006 I believe it is, it's
23 about 26,000.
24 Q Okay, so we're certainly over a quarter million since
25 you've come to Minnesota.
71

1 A Well, if you're taking my estimate of 180, adding 70 and
2 25, then, yes, it would be above 250,000.
3 Q Okay. Do you have any concerns that accepting that much
4 money from a drug company could impair your judgment in
5 any way?
6 MR. ALSOP: Objection on the basis of
7 relevancy and foundation, but go ahead, Doctor.
8 MS. AHMANN: And also, you said drug
9 company. I think he testified there were several drug
10 companies. Clarify.
11 BY DR. BARDEN:
12 Q Put an S on that. Do you think receiving funding from,
13 that level, from drug companies might impair your
14 judgment in some way? Do you have any concerns about
15 that?
16 A I have concerns about it. I think it would be
17 inappropriate to think that there could be none, and so I
18 think it is important to be aware that if a person is
19 working or collaborating with a pharmaceutical company,
20 to be aware that there may be a possibility that it could
21 influence a judgment.
22 Q Looking again at what's been marked as Exhibit --
23 MS. PEARSON: D.
24 BY DR. BARDEN:
25 Q D, I believe, "After Sanctions, Doctors Get Drug Company
72

1 Pay?"
2 A Okay. Which one is that, D or E?
3 MS. PEARSON: E.
4 BY DR. BARDEN:
5 Q E, E as in Edgar. Look at page 2 of 5 at the bottom
6 there. It says, "records most likely understate the
7 extent of the problem because they are incomplete. And
8 the Minnesota Board of Medical Practice disciplines --"
9 A I'm sorry. Where are you reading?
10 Q I'm sorry. Right here (indicating). We can just --
11 A Okay.
12 Q "The Minnesota Board of Medical Practice disciplines a
13 smaller share of the state's doctors than almost any
14 other medical board in the country, according to rankings
15 by Public Citizen." Were you aware of that?
16 MS. AHMANN: I'm going to object to vague.
17 I'm not sure what you're asking him. You read a couple
18 of sentences; they're different.
19 BY DR. BARDEN:
20 Q Okay. Are you aware of the fact that Minnesota
21 disciplines a smaller percentage of the state's doctors
22 than any other state?
23 MR. HUTCHINSON: According to that advocacy
24 group.
25 MR. ALSOP: Object on the basis of
73

1 foundation. He's already answered, but go ahead, if you
2 know.
3 THE WITNESS: My response is I'm seeing this
4 here. I don't have another way of knowing that.
5 BY DR. BARDEN:
6 Q Do you have any reason to doubt that's accurate, by the
7 way? Aren't there several sources that have validated
8 that?
9 A I'm not aware of any.
10 Q The next line says, "Dr. David Rothman, president of the
11 Institute of Medicine? Have you heard of the
12 Institute of Medicine?
13 A Yes, I have.
14 Q What is the Institute of Medicine?
15 A My understanding is the Institute of Medicine is an
16 organization made up of eminent physicians, but I think
17 psychologists and others can be members, I don't know
18 that for sure, that is a -- the membership, I believe,
19 includes people who have been named to the
20 National Academy of Science, and the organization itself
21 frequently looks at major health issues around the
22 United States.
23 Q It's a very prestigious group, isn't it?
24 A Absolutely.
25 Q And Dr. Rothman is the president of the Institute of
74

1 Medicine as a profession. It's a very prestigious
2 position, isn't it?
3 A Did that mean professor?
4 Q President.
5 A Well, it says Institute of Medicine as a profession.
6 That probably means professor, doesn't it?
7 Q No, as a profession.
8 A Okay, so that's his job.
9 Q Yeah.
10 A Okay.
11 Q So it says, quote, he said, quote, "'Clinical trial
12 investigators must be culled from --"
13 A I'm sorry, I was reading here. It said, "'There's no
14 reason to think Minnesota is unique.'"
15 Q Yes, and --
16 A Okay.
17 Q Right. "'There's no reason to think Minnesota is
18 unique.'" Hearing about the problems in Minnesota.
19 Isn't it true that Minnesota has a unique law requiring
20 physicians to disclose funding from drug companies?
21 MR. ALSOP: That's a misstatement of the
22 law, it's argumentative also, but go ahead. Calls for
23 legal conclusion.
24 BY DR. BARDEN:
25 Q Are you aware of whether Minnesota has a law requiring
75

1 physicians to disclose payments from drug companies?
2 A I am aware of a law in which pharmaceutical companies are
3 required to send to the pharmacy board the amounts of
4 money that companies provide to physicians, but the --
5 that's my understanding of the law.
6 Q Okay. Are you aware of any other state other than
7 Minnesota that has such a law?
8 A My understanding is that Vermont is the other state.
9 Q All right. So he says Minnesota, "'no reason to think
10 Minnesota is unique.'" He says, quote, "'Clinical trial
11 investigators,'" we're talking about a quote from
12 Dr. David Rothman again, "'must be culled from only the
13 finest physicians in the country,' he said, 'since they
14 work on the frontiers of new knowledge. That drug makers
15 are scraping the bottom of the medical barrel is an
16 outrage,'" unquote. Do you agree with Dr. Rothman's
17 statement there?
18 MR. ALSOP: It's irrelevant, but go ahead,
19 Doctor.
20 THE WITNESS: I'm pausing to make sure I
21 give a thoughtful response to your question. I'm going
22 to answer it in subparts.
23 The first part is that I have been involved
24 in clinical research since I started my clinical
25 associateship 30 years ago, and I certainly want to think
76

1 that the people involved in clinical research are good
2 doctors. The part that he says, that says, "drug makers
3 are scraping the bottom of the ... barrel is an outrage,"
4 I can't really comment on that. I don't know whether
5 they are or not. But I certainly do agree with
6 Dr. Rothman that it would be really a good idea if we
7 could have really good doctors be the ones who are
8 running these trials.
9 BY DR. BARDEN:
10 Q Has Dr. Abuzzahab done any drug research during the time
11 you've been at the University of Minnesota, to the best
12 of your knowledge?
13 A I don't have any -- there is no mechanism for me to read
14 any report one way or the other of whether he does, but I
15 have heard that he was looking for patients to
16 participate in a clinical trial during the last eight
17 years.
18 Q Well, on the front page of what's been marked as
19 Exhibit E, it says, "Dr. Abuzzahab, a Minneapolis
20 psychiatrist, is still overseeing the testing of drugs on
21 patients and is being paid by pharmaceutical companies
22 for the work."
23 A Okay.
24 Q "At least a dozen have paid him for research or marketing
25 since he was disciplined." Does that help?
77

1 A Yeah, I appreciate that, and it is in agreement with my
2 saying that I was aware, prior to this article, that he
3 was doing clinical research.
4 Q If you look on page 4 of 5 of what's been marked as
5 Exhibit E, it says, "In cases involving Dr. Abuzzahab
6 over 15 years in the '80s and '90s, the medical board
7 found he repeatedly prescribed narcotics and other
8 controlled substances to addicts, renewing one patient's
9 prescriptions six weeks after the patient was jailed and
10 telling another that his addictive pills should be
11 thought of as," quote, "'Hamburger Helper.' He
12 prescribed narcotics to pregnant patients, one of whom
13 prematurely delivered a baby who soon died," unquote.
14 Were you aware of these kinds of activities by
15 Dr. Abuzzahab?
16 A No.
17 Q Are you aware whether the medical licensing board's
18 report that suspended his license, are you aware of
19 whether that's a public document or not?
20 A I'm not aware.
21 Q Do you think having a person like Dr. Abuzzahab doing
22 drug research, and given the history with Dr. Garfinkel
23 and given the audit report that 71 percent of your
24 faculty didn't even know how to lodge a complaint of a
25 violation, do you think that shows a pattern of lax
78

1 management at the University of Minnesota Department of
2 Psychiatry?
3 MR. ALSOP: Object as irrelevant, multiple
4 question, and misstatement of the facts regarding the
5 drug research. You can answer.
6 MR. HUTCHINSON: Same, and lacking in
7 foundation.
8 THE WITNESS: So I'd like to respond, begin
9 my response to your question by the last point. You've
10 shown me our University audit, and in which a survey of
11 the faculty and staff responded to a questionnaire about
12 how to make a complaint regarding policy of the staff in
13 the academic department, and I just want to be clear that
14 the mechanism that I told you about earlier is a
15 University of Minnesota Medical Center at Fairview
16 document that is available on all the wards and was not
17 the scope of the University of Minnesota report. The
18 University of Minnesota report was focused on the
19 academic department and was asking such questions around
20 issues such as filing of expense forms, etc., was not
21 clinically focused.
22 So that was the third part of your
23 three-part question. If you could remind me the other
24 two parts.
25
79

1 BY DR. BARDEN:
2 Q The question was very simple. Do you think this shows a
3 pattern? Is there a pattern of lax management with
4 regard to protecting patients' rights at the
5 Department of Psychiatry, as demonstrated by the
6 Garfinkel, Abuzzahab, 71 percent of physicians not
7 knowing how to file complaints, and this case?
8 A I'm sorry, I just want to make sure I understand your
9 last statement. Seventy-one percent of who?
10 Q Do you recall we looked at the audit?
11 A Yeah, I do. Why don't we look at it again for a second
12 just to make sure.
13 Q It's page 11.
14 A I think we were looking at page 11.
15 MR. HUTCHINSON: Just while he's doing that,
16 just so the record is clear, I do object to the question
17 on the ground it lacks foundation, calls for speculation,
18 conjecture, and is irrelevant.
19 MR. ALSOP: I'll join in those objections.
20 THE WITNESS: Again, talking about the third
21 part of this, this audit, which is not addressing at all
22 the earlier process for clinical work on our wards, it
23 was concerning to me, and we have held a number of staff
24 meetings to further make sure that our staff understands
25 about these, and I do not think that there is, in the
80

1 Department of Psychiatry, since I've been department
2 chair, lax management, nor have I ever in my annual
3 meetings with my dean been criticized for lax management,
4 or any other reason to think that the management of the
5 department, since I arrived eight years ago, has been
6 deficient.
7 BY DR. BARDEN:
8 Q Okay. Do you have any other response?
9 A No.
10 Q Let's look back again at what's been marked as Exhibit D.
11 You can look at this. I put this together. Again, this
12 is the New York Times article, this is May 10, 2007.
13 It's the Psychiatrists, Children and Drug Industry's
14 Role." Do you see that?
15 A Yeah.
16 Q Have you read this article?
17 A Yes, I have.
18 Q Okay. Here it says, "the intersection of money and
19 medicine, and its effect on the well-being of patients,
20 has become one of the most contentious issues in health
21 care." Would you agree with that?
22 MS. AHMANN: Objection, lack of foundation.
23 MR. HUTCHINSON: I'll join.
24 THE WITNESS: Well, based on the number of
25 articles I've seen in the New York Times and the
81

1 Star Tribune, there certainly has been a lot of
2 discussion in the press about this.
3 BY DR. BARDEN:
4 Q See on page 2 of what's been marked as Exhibit D, it
5 says, this is a different one, "From 2000 to 2005 --"
6 A Let me just make sure. So which one are we looking at?
7 Q We're looking at D. I have it right in front of you
8 here. "From 2000 to 2005, drug maker payments to
9 Minnesota psychiatrists rose more than sixfold to
10 $1.6 million. During those same years, prescriptions of
11 antipsychotics for children in Minnesota's Medicaid
12 program rose more than ninefold." Were you aware that
13 drug maker payments to Minnesota psychiatrists rose
14 sixfold during your time here at Minnesota?
15 MS. AHMANN: Again, lack of foundation.
16 MR. ALSOP: I'll join in that.
17 MR. HUTCHINSON: Yeah.
18 THE WITNESS: And where did that number come
19 from?
20 BY DR. BARDEN:
21 Q This is the New York Times articles.
22 A No, I understand. But where did the figure, where did
23 the reporter get the figure 1.6 million.
24 Q It came from the state public reports of drug company
25 marketing payments.
82

1 A Okay. Pardon me.
2 MR. ALSOP: The question was were you aware
3 of that or not. If you're not --
4 BY DR. BARDEN:
5 Q Were you aware of that or not?
6 A No.
7 Q Before you came to Minnesota, had you had relationships
8 with drug manufacturers at the other universities that
9 you worked at?
10 MS. AHMANN: Object as vague.
11 BY DR. BARDEN:
12 Q I'll make it more specific. Had you received money from
13 drug manufacturers before you came to Minnesota?
14 A Yes.
15 Q Were you known as someone who had good relationships with
16 drug manufacturers before you came to Minnesota?
17 MR. ALSOP: Object on the basis --
18 MR. HUTCHINSON: Object as lacking in
19 foundation as to what other people thought.
20 MS. AHMANN: Same.
21 MR. ALSOP: I'll join in that. You can
22 answer, Doctor.
23 THE WITNESS: I can?
24 MR. ALSOP: If you know.
25 THE WITNESS: Well, I don't know about what
83

1 my reputation is, but honestly speaking, I have worked in
2 the area of clinical trials, as I mentioned earlier, for
3 a number of different years, and I have given lectures
4 for a number of different companies since about 1980.
5 BY DR. BARDEN:
6 Q Were you in fact brought to Minnesota in part to improve
7 the relationship between Minnesota psychiatrists and drug
8 companies?
9 A No.
10 Q You think it's a coincidence that payments to Minnesota
11 psychiatrists rose sixfold during the years that you've
12 been here?
13 MR. ALSOP: Object as argumentative.
14 MR. HUTCHINSON: Does that say University of
15 Minnesota?
16 MR. ALSOP: It doesn't, it doesn't.
17 BY DR. BARDEN:
18 Q It says Minnesota psychiatrists. Do you think it's a
19 coincidence that drug maker payments to Minnesota
20 psychiatrists has rose more than sixfold to $1.6 million
21 during the 2000 to 2005 time period?
22 MR. ALSOP: Now it's vague and it's lacking
23 in foundation and it's argumentative, but go ahead.
24 MS. AHMANN: Join.
25 MR. HUTCHINSON: Join.
84

1 THE WITNESS: I don't mean to slow the
2 proceedings down, but the question had some parts. If
3 you could just restate the question for me so I can
4 respond.
5 BY DR. BARDEN:
6 Q Do you think that your coming to Minnesota and your
7 relationships that you brought with drug manufacturers is
8 related to what's reported in the New York Times, that
9 is, the drug maker payments to Minnesota psychiatrists
10 rose more than sixfold to $1.6 million from 2000 to 2005,
11 the years when you have been the chairman of psychiatry
12 at Minnesota?
13 MR. ALSOP: Same objections.
14 BY DR. BARDEN:
15 Q Do you see a relationship --
16 MS. AHMANN: Same objection.
17 BY DR. BARDEN:
18 Q -- or not?
19 A No.
20 Q It goes on to say, again, we're in Exhibit D, "studies
21 present strong evidence that financial interests can
22 affect decisions, often without people knowing it." Are
23 you aware of any such research, Doctor?
24 A I am aware that there is sociology research in which
25 sociologists have studied the fact of a person receiving
85

1 a gift and the subsequent behavior. As far as the
2 specific research that you pointed out here, I'm not
3 aware of that.
4 Q Have you read any of the social-psychological research on
5 the effect of financial incentives?
6 A I've attended a lecture about it.
7 Q Can you tell me any of the researchers that do any of
8 that work?
9 A No. I don't know their names.
10 Q Can you tell me of the economic research of the effect of
11 financial incentives on decision-making?
12 A I don't know that research.
13 Q Do you know anything about it?
14 A Well, I think I already indicated I've been to a grand
15 rounds lecture about the topic that was given in our
16 department probably in 2005.
17 Q Are you aware of any other kinds of marketing research or
18 additional research showing the impact of financial
19 incentives on people's decision-making, even when they're
20 not aware of such an impact?
21 A I think the studies that I alluded to earlier presented
22 in the overall teaching grand rounds is my recent
23 information or what I know about this.
24 Q And when did you attend that?
25 A I believe it was in the end of 2005.
86

1 Q So during the time that Dan Markingson was in the CAFE
2 study, of which you were a coinvestigator, you were not
3 aware of the social-psychological, sociological, or
4 economic research showing the effects of financial
5 incentives on decision-making?
6 MR. ALSOP: That's argumentative and
7 misstating of his testimony, but go ahead, Doctor.
8 MS. AHMANN: I join, and also raise lack of
9 foundation.
10 THE WITNESS: Yeah, it's difficult for me to
11 say, to say that -- no, pardon me. It is easy. No, I'm
12 not aware of that research.
13 BY DR. BARDEN:
14 Q And as you sit there now, you can't tell me any of the
15 leaders of that research field, can you?
16 A I don't know their names, no.
17 Q Do you know, for example, if someone won a Nobel Prize
18 for doing just that kind of research?
19 A No, I don't know.
20 Q It goes on to say, again this is Exhibit D, in Minn --
21 MR. ALSOP: Counsel, what page or what --
22 DR. BARDEN: We're on page 2 of 7, right in
23 the middle.
24 MR. ALSOP: Thank you.
25
87

1 BY DR. BARDEN:
2 Q "In Minnesota, psychiatrists collected more money from
3 drug makers from 2000 to 2005 than doctors in any other
4 specialty." Do you know why that might be, as the
5 chairman of psychiatry, why would psychiatrists receive
6 more money from drug makers than any other specialty?
7 MS. AHMANN: Object to lack of foundation.
8 MR. ALSOP: I'll join.
9 MR. HUTCHINSON: Same.
10 THE WITNESS: Without seeing that primary
11 data, I don't know if I can agree to that, so then I
12 can't speculate as to why that might be the case.
13 BY DR. BARDEN:
14 Q Okay. Well, for the purposes of this question, I'd like
15 you to tell me if there is any reason why psychiatrists
16 would receive more drug money than any other specialty.
17 MS. AHMANN: Same objection.
18 MR. ALSOP: Same objection.
19 THE WITNESS: No, I can't.
20 BY DR. BARDEN:
21 Q Once again, we're looking at page 2 of 7, Exhibit D,
22 "Dr. Stephen H. Hyman, the provost of
23 Harvard University." You've heard of Harvard University?
24 A Yes, I have.
25 Q Do you think being the provost of Harvard University is a
88

1 fairly prestigious job in the academic world?
2 A Yes, I do.
3 Q He's the former director of the National Institute of
4 Mental Health. Do you think that's a fairly well-known
5 job?
6 A It's a highly visible job for sure.
7 Q And Dr. Stephen Hyman said, quote, "'There is an irony
8 that psychiatrists ask patients to have insights into
9 themselves, but we don't connect the wires in our own
10 lives about how money is affecting our profession and
11 putting our patients at risk,'" unquote. Would you agree
12 with that statement from Dr. Hyman?
13 A I wouldn't.
14 Q You would not.
15 A Yeah, that's correct.
16 Q Do you know a Dr. Realmuto, George M. Realmuto?
17 A Yes, I do.
18 Q Do you know if he's doing drug research at Minnesota?
19 A I know he has. I don't know if he is currently doing --
20 I would say research with medications, but I don't know
21 if he has any current medication protocols right now.
22 Q Okay. Looking again at page 3 of 7 of what's been marked
23 as Exhibit D, Dr. Realmuto said, well, here we're in the
24 middle, "The money is nice, too, he said. Dr. Realmuto's
25 university salary is $196,310." Quote, "'Academics don't
89

1 get paid very much,' he said." Quote, "'If I was an
2 entertainer, I think I would certainly do a lot better,'"
3 unquote. Have you ever talked to Dr. Realmuto about his
4 salary?
5 A I set his salary.
6 Q Okay, so is that --
7 A So, yes, I have talked about his salary, correct.
8 Q Is this statement accurate, to the best of --
9 A To the best --
10 MR. ALSOP: You're not going to talk about
11 Dr. Realmuto's salary. You're not to answer the
12 question.
13 BY DR. BARDEN:
14 Q Okay. Is the sentence -- okay.
15 MR. ALSOP: He's not going to comment
16 upon --
17 DR. BARDEN: He already did, that's fine.
18 BY DR. BARDEN:
19 Q Do you agree academics don't get paid very much, at
20 196,000 is not very much?
21 A I think Dr. Realmuto made some unfortunate comments in
22 that article, and I did talk with him about it
23 afterwards.
24 MR. ALSOP: No, no, Doctor. The question is
25 do you agree with that statement or not. If you don't --
90

1 THE WITNESS: Thanks for reminding me. The
2 question again is do I think doctors get paid --
3 MR. ALSOP: Paid enough.
4 BY DR. BARDEN:
5 Q Do you think $196,000 is not very much?
6 A I don't agree with that statement.
7 Q Let's look at what's been marked as Exhibit D again,
8 page 4 of 7. Dr. Steven S. Sharfstein, immediate past
9 president of the American Psychiatric Association. Do
10 you know him, by the way, have you ever met him?
11 A I have met him, yeah.
12 Q That's a very prestigious job, isn't it --
13 A Yes.
14 Q -- being president of the APA?
15 A Yes, it is.
16 Q He said, "psychiatrists have become too cozy with drug
17 makers." Do you agree with that?
18 A Not as a broad-brush statement, no.
19 Q So you don't agree with Dr. Sharfstein and you don't
20 agree with Dr. Hyman?
21 MR. ALSOP: It's repetitious. We've
22 established that twice now.
23 BY DR. BARDEN:
24 Q In terms of the effect of money on the psychiatry
25 profession, correct?
91

1 MR. ALSOP: Now it's vague and ambiguous.
2 BY DR. BARDEN:
3 Q Drug money.
4 MR. ALSOP: That's vague and ambiguous and a
5 misstatement of their quotes, but go ahead, Doctor.
6 THE WITNESS: I don't agree with the
7 statements in that article.
8 DR. BARDEN: Okay. We'll mark this as
9 Exhibit F.
10 MS. AHMANN: What is it?
11 MS. PEARSON: It is the CAFE study
12 schizophrenia CME.
13 (Schulz Deposition Exhibit F marked for
14 identification.)
15 MS. AHMANN: I think that's a misstatement.
16 It isn't CAFE study.
17 MS. PEARSON: I'm sorry. I was talking to
18 Bridget, so I wasn't looking exactly at the title.
19 DR. BARDEN: We'll let Dr. Schulz identify
20 the exhibit.
21 THE WITNESS: Okay.
22 BY DR. BARDEN:
23 Q If you would.
24 A All right.
25 MR. HUTCHINSON: Well, you know, counsel,
92

1 despite what you said earlier, I do want to be looking at
2 the exhibit, if you're asking the witness about it, and
3 I'm not at all troubled by having copies made here.
4 We'll pay for them.
5 DR. BARDEN: Yeah.
6 MS. PEARSON: You have a copy in your
7 production, you do.
8 BY DR. BARDEN:
9 Q Okay. If you can identify that for the record, please?
10 A Can I just -- do I need to wait for him to get his copy?
11 MR. HUTCHINSON: Just tell us what it is so
12 we know what to look for.
13 DR. BARDEN: We're going to spend about a
14 minute on this document.
15 THE WITNESS: Okay.
16 BY DR. BARDEN:
17 Q Okay.
18 A This looks like a copy of a handout from a University of
19 Minnesota CME program, cosponsored by the
20 International Congress on Schizophrenia Research and
21 the -- I was going to give the title of the program.
22 Q Oh, sorry.
23 A The title of the program Schizophrenia Treatment Bridging
24 Science to Clinical Care, and it's from April of 2006.
25 Q This has been marked as Exhibit F. Okay. I'll show you
93

1 page, this is the prepages, Roman numeral V, it looks
2 like, and I will point you out to the bottom third of the
3 page that says S. Charles Schulz, M.D. That would be
4 you, sir?
5 A That's correct.
6 Q Can you read into the record what it says after that?
7 A It says -- this is taken from a form the CME office has
8 people fill out. It says "Consultant," and after that it
9 says "Eli Lilly, AstraZeneca," then it says "Speaker's
10 Bureau," and I put "Eli Lilly, AstraZeneca;
11 Grant/Research ... Abbott" Pharmaceutical, well, "Abbott,
12 Eli Lilly; Honoraria: AstraZeneca," and it said "I do
13 [not] intend to discuss off-label/investigative use(s) of
14 the following commercial --" "I do intend to," I
15 apologize, "do intend to discuss off-label use(s) of ...
16 olanzapine, risperidone, quetiapine, ziprasidone, [and]
17 aripirazole in teenagers."
18 Q Okay. When it says "Consultant: AstraZeneca,
19 Bristol-Myers Squibb, Pfizer," etc., those are companies
20 that have paid you a consultant fee, correct?
21 A Yes.
22 Q Okay, and when it says "Speaker's Bureau," are those
23 companies that have also paid you a speaking fee?
24 A Correct.
25 Q And when it says "Principal Investigator ... working
94

1 directly for [the] company --"
2 A No, it says "or."
3 Q Yeah, "Principal Investigator or working directly for
4 company/company's agent," see it says AstraZeneca there,
5 correct?
6 A That's under Dr. Olson's name.
7 Q Oh, I'm sorry, I've gone down one. Yours is honoraria,
8 it says AstraZeneca, correct?
9 A Well, let me make sure, because you read this part up
10 here, working directly with, etc., etc., and that's at
11 Abbott and Lilly.
12 Q And then it says honoraria?
13 A Honoraria was a separate category, AstraZeneca.
14 Q And this page is in the record, just to make it perfectly
15 clear.
16 A Yeah.
17 Q Okay, so okay.
18 MR. HUTCHINSON: I didn't understand what
19 that meant. This page is in the record?
20 DR. BARDEN: This page is in the record, so
21 there will be no confusion about what it says.
22 MR. HUTCHINSON: You mean it's an exhibit to
23 this deposition.
24 DR. BARDEN: It is, it is.
25 MR. HUTCHINSON: Oh, thank you.
95

1 BY DR. BARDEN:
2 Q Okay. Are there any drug companies for which you have
3 received money other than the ones you've disclosed on
4 this page?
5 MR. ALSOP: It's vague as to time. Go
6 ahead.
7 DR. BARDEN: I think that's a very good
8 objection.
9 MR. ALSOP: Well, thank you.
10 BY DR. BARDEN:
11 Q During the time that Mr. Markingson was treated at the
12 Department of Psychiatry and was a subject in the CAFE
13 study on which you were a coinvestigator, were you
14 receiving funding from any drug company other than the
15 ones that are listed on this page?
16 MS. AHMANN: I'm going to object of lack of
17 foundation, it's assuming that these he was receiving at
18 the time, but, state my objection.
19 MR. HUTCHINSON: I'm not sure where we are
20 here.
21 MR. ALSOP: I'm not sure there is a
22 question.
23 DR. BARDEN: There is a question pending.
24 BY DR. BARDEN:
25 Q Are there any other companies than the ones listed there
96

1 for which you were -- see, they make objections and then
2 you answer the question.
3 A No, I understand. Just you were looking around, I didn't
4 know. So let me be clear that the forms that are filled
5 out that lead to these statements are for the 12 months
6 preceding the conference. So this would describe the
7 period of April 2005 to 2006, and my recollection would
8 be that this is similar to my activities in 2004.
9 Q Okay, so there are no companies other than the ones
10 listed, to the best of your knowledge.
11 A I can't say for sure.
12 Q Okay.
13 DR. BARDEN: I'm going to have the witness
14 identify this, and then we'll decide if we're going to
15 make it an exhibit or not.
16 BY DR. BARDEN:
17 Q Can you identify this document for us?
18 MR. HUTCHINSON: This is Exhibit G?
19 DR. BARDEN: It might be.
20 MR. HUTCHINSON: Oh.
21 THE WITNESS: I don't recognize this.
22 BY DR. BARDEN:
23 Q Okay. On the front it says AstraZeneca results update,
24 David Brennan. Do you know a David Brennan?
25 A I believe he works for AstraZeneca and I think -- let me
97

1 see. The date is --
2 Q 2005, August.
3 A August 2005.
4 Q Okay. Well, let me show you page 17 of this document.
5 MS. AHMANN: Well, I'm going to object.
6 MR. ALSOP: If you're going to go beyond
7 that and talk about the document, I want it marked.
8 DR. BARDEN: Yeah, we are going to mark it,
9 if he recognizes it or if --
10 MS. AHMANN: He said he didn't recognize it.
11 MR. ALSOP: He said he didn't.
12 DR. BARDEN: He recognized the name of the
13 person that produced it, so now we're trying to determine
14 if we're going to make --
15 BY DR. BARDEN:
16 Q I just want to show you these two graphs and ask you, to
17 the best of your knowledge, if they're accurate.
18 MS. AHMANN: Just a second. You're either
19 going to make it an exhibit or not. He said he's not --
20 THE WITNESS: I've not seen it.
21 DR. BARDEN: These are speaking objections.
22 MR. ALSOP: He's not going to respond. You
23 asked him to comment on the accuracy.
24 DR. BARDEN: We're going to make it an
25 exhibit after he --
98

1 MR. ALSOP: No. You did not ask him to
2 identify it, you asked him if it was accurate, you didn't
3 merely do --
4 DR. BARDEN: To identify whether the
5 information is accurate or not, that is correct.
6 MR. ALSOP: He hasn't seen it before.
7 MS. AHMANN: Do you have a copy?
8 DR. BARDEN: You know, I don't. This will
9 be Exhibit G, and you're welcome to look over our
10 shoulder, if you like. There are two charts here, which
11 I'm going to ask you questions about.
12 MS. AHMANN: Can I see the cover, just for a
13 second?
14 BY DR. BARDEN:
15 Q Okay? Let me do a little foundation. Have you ever been
16 to any medical meetings where slides are shown?
17 A I have been to medical meetings where slides have been
18 shown.
19 Q And have there been charts and graphs shown at medical
20 meetings?
21 A I've been to medical meetings where charts have been
22 shown as well.
23 Q And have you ever been to meetings where charts regarding
24 the drug Seroquel has been shown?
25 A I think -- I have been to medical meetings where slides
99

1 have been shown about Seroquel, and I'd like to take a
2 break.
3 Q Okay. You're certainly welcome to do that.
4 MS. AHMANN: Are you going to talk about the
5 document? Then I'd like to get copies for people to look
6 on.
7 MR. ALSOP: As long as we're taking a short
8 break, we'll get copies, that's fine.
9 MR. HUTCHINSON: Is this a document we've
10 received before?
11 MS. AHMANN: No.
12 MR. HUTCHINSON: Then I'd like a copy, as
13 long as we're going to review it. This might be a good
14 time, if there are other documents we haven't seen
15 before, that we can get a copy during the break. I'll be
16 glad to pay for it.
17 DR. BARDEN: Well, there are many documents.
18 We don't know which ones will be exhibits yet, so we'll
19 go through it as we can. All these documents --
20 MR. HUTCHINSON: On the fly.
21 DR. BARDEN: All these documents have been
22 disclosed to you, is my understanding.
23 MS. AHMANN: Yeah, she just said that it
24 hasn't.
25 MR. HUTCHINSON: But, counsel --
100

1 (Brief recess taken.)
2 DR. BARDEN: We are back on the record.
3 Just in terms of scheduling and moving things along, if
4 we could go until like 12:30 and break for lunch, I think
5 we can make some copies. Mr. Alsop has asked --
6 MR. ALSOP: If he piles up a list of what he
7 may use during that half-hour lunch break, I'll have our
8 office make copies for everyone.
9 DR. BARDEN: Rapidly. Okay.
10 BY DR. BARDEN:
11 Q Doctor, I want to go back briefly to what was marked as
12 Exhibit F, which was the lecture summaries second
13 biennial schizophrenia treatment at the Hyatt Regency
14 presented by a number of agencies, including the
15 Department of Psychiatry, correct?
16 A That's correct.
17 Q 2006. And we had discussed, on page Roman numeral V,
18 that you were going to discuss off-label/investigative
19 use of a number of commercial products, including some
20 drugs, correct?
21 A Well, let me double check, please.
22 Q Go ahead, go ahead and check that, we'll make sure it's
23 accurate.
24 A Okay. So page V says that I disclosed "I do intend to
25 discuss off-label/investigative use(s) of the following
101

1 commercial product(s) [or] device(s)," and I listed five
2 atypical antipsychotic medications in teenagers.
3 Q Right. And then the next page, Roman numeral VI, do you
4 see where it says, "Acknowledgement. Support for the 2nd
5 Biennial Schizophrenia Treatment conference has been
6 provided from the following companies?" Do you see under
7 gold level, what's the first company listed?
8 A Well, I think it's listed by alphabetical order,
9 AstraZeneca, starting with A is first, then
10 Bristol-Myers Squibb, third is Eli Lilly, and fourth is
11 Janssen Pharmaceutica.
12 Q And when it says support, it means financial support,
13 correct?
14 MS. AHMANN: I object, and --
15 BY DR. BARDEN:
16 Q These companies are providing financial support for the
17 conference.
18 A For this conference, the University of Minnesota
19 Department of Continuing Medical Education submitted a
20 grant to the CME support grant office of each of these
21 companies to ask them for an unrestricted educational
22 grant to the conference.
23 DR. BARDEN: Objection, move to strike as
24 nonresponsive.
25 THE WITNESS: I'm sorry, what was the
102

1 question?
2 MR. ALSOP: You answered the question,
3 Doctor. He can make his objection.
4 BY DR. BARDEN:
5 Q This means that these companies provided financial
6 support for this conference, correct?
7 A Correct.
8 Q Thank you. Now, are you aware of any restrictions on
9 companies marketing off-label uses for their drugs, for
10 their medication?
11 A Yes, I am.
12 Q Okay, but it's okay for them to finance a conference at
13 which you, a physician, speak about or endorse off-label
14 uses, correct?
15 MS. AHMANN: I'm going to object, lack of
16 foundation, misstatement. He talked about investigative
17 uses as well.
18 MR. ALSOP: You can answer, Doctor.
19 DR. BARDEN: Uh-huh.
20 THE WITNESS: What, you'd like me to answer?
21 MR. ALSOP: Yes, go ahead.
22 BY DR. BARDEN:
23 Q But you as a physician can speak out and endorse or
24 support off-label use of medications, correct?
25 A Not really, and why don't I just take a minute to address
103

1 the question, if I could.
2 Q Sure.
3 A I mentioned earlier that this conference was put on by
4 the Department of Psychiatry and other agencies. We
5 received CME support from, or accreditation, from the
6 University of Minnesota. The money came from those
7 companies through their educational grant office. The
8 talks have to be judged to be fair, balanced, and not to
9 be specifically recommending one treatment over another,
10 if there is no basis for that.
11 Q Okay, but you have given speeches where you recommend
12 off-label uses of medications, correct?
13 A I have given talks where I've talked about research on
14 off-label use for medications, that's true.
15 Q Okay. Have you ever done that with a drug manufactured
16 by AstraZeneca?
17 A Let me make sure I understand the question I'm answering.
18 Have I ever given a talk about --
19 Q Supporting off-label use of a drug manufactured by
20 AstraZeneca, and by supporting, I mean you're either
21 endorsing it, supporting it, presenting research evidence
22 showing it's a good idea, etc.
23 MS. AHMANN: I'm going to object, lack of
24 foundation, misstates what he said. He said he has given
25 talks about research.
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1 MR. ALSOP: I would join in that. It's a
2 misstatement. He never suggested he supported it. But
3 go ahead, you can answer.
4 THE WITNESS: So I have given lectures about
5 atypical antipsychotic medications in the area of
6 chronic psychosis in people under age 18, and I have
7 given talks about atypical antipsychotic medications for
8 people with borderline personality disorder, for which
9 there is no FDA drug.
10 BY DR. BARDEN:
11 Q So that would include Seroquel, right?
12 A It would depend on the talk, but sometimes it would.
13 Q So recommending Seroquel for bipolar disorder would be an
14 off-label use, right?
15 A Okay. I have to be clear. I didn't ever say I
16 recommended Seroquel.
17 Q Okay. I'm not using the word recommended.
18 A Well, you just did.
19 MR. ALSOP: You did.
20 BY DR. BARDEN:
21 Q Support, endorse, whatever.
22 A And I would not characterize my talks --
23 Q But you've talked about the use of atypicals for bipolar.
24 A Pardon me?
25 Q You've talked about the use of atypicals for bipolar?
105

1 A I didn't say anything about bipolar.
2 MS. AHMANN: Okay. I join in that
3 statement, misstatement.
4 BY DR. BARDEN:
5 Q What are -- what have you done?
6 A I described that I have talked about the research in the
7 area of atypical antipsychotic medications in people
8 under the age of 18, and I've talked about atypical
9 antipsychotics for borderline personality disorder.
10 Q Oh, I'm sorry, it was borderline, okay.
11 MR. ALSOP: Let him finish, please.
12 THE WITNESS: And that there is no
13 FDA-approved medicine for borderline personality
14 disorder. Further, in those talks, I've also described
15 research results of other classes of compounds, such as
16 SSRIs or anticonvulsive destabilizers.
17 BY DR. BARDEN:
18 Q And it is your understanding a representative, a direct
19 employee of AstraZeneca, wouldn't be able to give such
20 talks, would they?
21 MS. AHMANN: Objection, lack of foundation.
22 MR. HUTCHINSON: Same.
23 MR. ALSOP: Go ahead, you can answer.
24 THE WITNESS: My understanding of the roles
25 would be that a person known as a drug rep, or
106

1 pharmaceutical representative, whose job it is to visit
2 doctors and visit hospitals, has to stay on the
3 FDA-approved indications for compound.
4 BY DR. BARDEN:
5 Q Uh-huh. So one way the drug companies can get out
6 information about off-label uses is to set up conferences
7 and to hire speakers and to have them do it, correct?
8 MR. ALSOP: Object as argumentative.
9 MS. AHMANN: Lacking in foundation.
10 MR. ALSOP: Argumentative, lacking in
11 foundation. Go ahead, Doctor.
12 MS. AHMANN: Join.
13 THE WITNESS: I can't agree with that
14 statement, no.
15 BY DR. BARDEN:
16 Q That's not a marketing tool that's used by manufacturers?
17 MS. AHMANN: Same objection.
18 THE WITNESS: I don't know. I don't know
19 what their plans are.
20 BY DR. BARDEN:
21 Q How much does, to the best of your knowledge, and as
22 someone who works with these medications and as someone
23 who has a consulting relationship with AstraZeneca, how
24 much money does AstraZeneca make from the sale of
25 Seroquel in any given year?
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1 MR. ALSOP: Object as lacking in foundation,
2 speculative. Go ahead, Doctor.
3 THE WITNESS: I don't know.
4 BY DR. BARDEN:
5 Q Do you have any idea at all?
6 A I don't.
7 MR. ALSOP: Don't speculate.
8 BY DR. BARDEN:
9 Q If Dr. Olson had stated it was probably more than
10 3 billion a year, would you disagree with that?
11 MR. ALSOP: Object as speculative, also
12 repetitious.
13 THE WITNESS: I wouldn't know how to agree
14 or disagree with that.
15 BY DR. BARDEN:
16 Q Do you have any idea at all of the market share of
17 Seroquel?
18 MS. AHMANN: Same objection.
19 THE WITNESS: That's a different question,
20 and I am aware that the, quote, market share of
21 quetiapine is around 25 to 28 percent of antipsychotic
22 prescriptions.
23 BY DR. BARDEN:
24 Q And how does that compare to the other antipsychotic
25 prescriptions?
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1 A I think it's tied with risperidone and is recently a
2 little more than olanzapine.
3 Q And what percentage of AstraZeneca's profits come from
4 the sale of Seroquel?
5 A I have no idea.
6 MS. AHMANN: Objection.
7 BY DR. BARDEN:
8 Q You have no idea at all.
9 A Nope.
10 Q We show you what's been marked now as Exhibit G. And
11 this is a -- these are some slides from an AstraZeneca
12 results update given by David Brennan and a U.S. business
13 update for AstraZeneca given by Tony Zook, and an
14 AstraZeneca US Seroquel update given by Johan Hoegstedt,
15 and they're all dated 2005. Do you know a Tony Zook?
16 MS. AHMANN: I'm going to object generally
17 to the exhibit. I'm not sure where you got it. I
18 haven't seen it before. To the extent it was produced in
19 the MBO, I object that there is a protective order, to
20 which you're not a party. Like I said, I don't know
21 where you got it. So I'm also going to object as to the
22 timing, the irrelevant to anything that happened here,
23 and as to the lack of foundation.
24 DR. BARDEN: For the record, this document
25 is freely available on the internet for AstraZeneca.
109

1 BY DR. BARDEN:
2 Q So let me just go ahead and show you these two slides,
3 which are on page 17 of what's been marked as Exhibit G.
4 DR. BARDEN: Actually, we haven't marked it.
5 (Schulz Deposition Exhibit G marked for
6 identification.)
7 BY DR. BARDEN:
8 Q Okay. Dr. Schulz, do you see where it says, "Seroquel
9 Continues to Drive the Global Atypical Market?" Do you
10 see that?
11 A Yeah, I see the type and the slide.
12 MR. HUTCHINSON: I'm missing the page
13 number, I'm sorry.
14 MR. ALSOP: Seventeen.
15 DR. BARDEN: Seventeen.
16 BY DR. BARDEN:
17 Q And it says, "Global Atypical Market $14 billion." Would
18 that fit with what you understand the global atypical
19 drug market to be, $14 billion.
20 MS. AHMANN: Object, lack of foundation.
21 THE WITNESS: I don't know.
22 MR. HUTCHINSON: Same.
23 THE WITNESS: I don't have any idea.
24 BY DR. BARDEN:
25 Q You don't have any idea at all?
110

1 MR. ALSOP: It's repetitious. We've
2 established he doesn't have any idea.
3 BY DR. BARDEN:
4 Q And then it says, "Seroquel Global Sales in 1H:
5 $1.3 billion?"
6 A What's 1H? I don't know what that is.
7 Q Have you ever seen this slide before?
8 A I don't recall ever seeing this slide before.
9 Q Have you ever seen any market share slides of Seroquel
10 before?
11 A You know, right below this, you have a slide that says
12 market share.
13 Q Yes.
14 A And I've been to a number of meetings over the years, and
15 many companies present this slide, which is gathered from
16 a national source. So I have seen slides like this in
17 the past.
18 Q So you've seen, you've been to a number of meetings where
19 you've seen slides of the market share of various drugs,
20 correct?
21 A That's correct.
22 Q Okay, and on this one, 2005, it says, "Seroquel Leads the
23 US Market in Share." Is that what that says?
24 A That's what the title is, of the slide is.
25 Q And that would be consistent with the number you gave us,
111

1 right? Here it's 27 percent.
2 A Uh-huh.
3 Q And you thought it was close?
4 A I think I said about 25.
5 Q Okay. Have you seen any publications, any news articles
6 in the mass media, indicating that Seroquel in fact
7 brings in billions of dollars --
8 A No.
9 Q -- to the AstraZeneca company?
10 A No, I haven't.
11 Q Have you ever discussed this with any of your psychiatric
12 colleagues?
13 MR. ALSOP: Discussed what, how much money
14 they make? That's vague.
15 BY DR. BARDEN:
16 Q Yeah, the money that is involved in psychiatric drugs.
17 MR. ALSOP: That's irrelevant, but go ahead,
18 Doctor. It's vague.
19 THE WITNESS: I guess -- let me tell you
20 my --
21 BY DR. BARDEN:
22 Q It's just a yes-or-no question at this point.
23 A -- confusion. Yes, yes, I have.
24 Q You have discussed it.
25 A Yes.
112

1 Q Have you discussed the increase in the financial worth of
2 psychiatric drugs to pharmaceutical companies, have you
3 discussed that issue with any of your colleagues?
4 A I don't think so.
5 Q Have you discussed the increase in the use of psychiatric
6 drugs in the general population over the last 15 years,
7 have you discussed that with any of your colleagues?
8 A Well, I'm not aware of that increase, but -- let me just
9 recollect for a second. I'm sure that I've had hallway
10 conversations, either, you know, say at a meeting, like
11 APA or elsewhere, in which the discussion of the use of
12 medicines and the issues of expense of medicines in
13 trying to manage and care for people with serious
14 psychiatric illness.
15 Q Uh-huh. Have you ever had discussions with colleagues
16 about the newer atypical drugs being vastly more
17 expensive than the older antipsychotic drugs?
18 MS. AHMANN: I object to lack of foundation.
19 THE WITNESS: I think I'll answer the
20 question by saying it has been an issue since about 1990
21 or 1991 that the atypical antipsychotic medications cost
22 more than the original traditional antipsychotic
23 medications, but that economic studies of say the first
24 of the atypicals to come out discussed that because the
25 medicine led to symptomatic relief of many people, that
113

1 the hospital costs for those patients went way down, and
2 so the net cost to a system was the same or improved.
3 BY DR. BARDEN:
4 Q And have more recent studies found those earlier research
5 studies to be in error?
6 A I haven't read any recently.
7 Q Have you read any recent studies indicating that the
8 new -- well, let me back up a minute.
9 How much more expensive are the atypicals
10 than the older antipsychotics?
11 MR. HUTCHINSON: What year are we talking
12 about now?
13 MR. ALSOP: Currently?
14 BY DR. BARDEN:
15 Q During the time that Mr. Markingson was treated in the
16 CAFE study on which you were a coinvestigator.
17 MR. ALSOP: Object on the basis of
18 foundation, but go ahead, Doctor.
19 THE WITNESS: Well, I think the best way I
20 can answer that is that I'm aware that the medicine that
21 was used a lot through the late '70s and '80s,
22 haloperidol, is a generic medication and is
23 particularly -- is inexpensive. I have heard in
24 conversation, but I'm not sure I've seen on paper, that a
25 person being managed with haloperidol, expense might be
114

1 500 to 750 dollars a year. I don't have any current
2 knowledge of the cost of risperidone or quetiapine or
3 olanzapine for a year, but my understanding is the costs
4 can fluctuate from $2,200 up to $5,000 or $6,000 a year.
5 BY DR. BARDEN:
6 Q Isn't it widely known in the psychiatric field and in the
7 general public that the newer atypicals cost about ten
8 times as much as the older antipsychotic drugs, and that
9 this dramatically increased expense is leading to extreme
10 struggles for states that have to finance these new
11 drugs?
12 MS. AHMANN: Object, lack of foundation,
13 multiple question.
14 MR. ALSOP: First of all, it's a multiple
15 question, lacking foundation, it's irrelevant, but go
16 ahead, Doctor.
17 THE WITNESS: As I said before, I gave you
18 estimates, and my understanding of the cost of the
19 compounds, in a comparison. I don't know whether that's
20 ten times more or not. I am aware that states and
21 community mental health centers, veterans hospitals, are
22 concerned about the increased costs of medications and
23 trying to figure out how to best budget for those.
24 BY DR. BARDEN:
25 Q You just talked about early studies showing that the new
115

1 atypical drugs actually have an economic benefit because
2 they work better. Isn't that what you said?
3 A That's what I said. I think I said early studies.
4 Q And you've given talks throughout the years about how
5 much better the atypicals are than the older drugs,
6 correct?
7 A Yes, I have.
8 Q Okay.
9 DR. BARDEN: Mark now Exhibit No. H, and I
10 do have copies of that.
11 (Schulz Deposition Exhibit H marked for
12 identification.)
13 BY DR. BARDEN:
14 Q Have you read this article from the Associated Press,
15 first published in the Washington Post?
16 A I don't believe so.
17 Q Okay. Let's take a look at this. This is October 3,
18 2006. "Schizophrenia patients do as well, or perhaps
19 even better, on older psychiatric drugs compared with
20 newer and far costlier medications, according to a study
21 published yesterday that overturns conventional wisdom
22 about antipsychotic drugs, which cost the United States
23 $10 billion a year." Would that be in keeping with your
24 understanding, that the drugs cost $10 billion a year?
25 MS. AHMANN: Object, lack of foundation.
116

1 THE WITNESS: I don't know how much the
2 drugs cost a year.
3 BY DR. BARDEN:
4 Q Okay. Third paragraph, "The study, funded by the British
5 government, is the first to compare treatment results
6 from a broad range of older antipsychotic drugs against
7 results from newer ones. The study was requested by
8 Britain's National Health Service to determine whether
9 the newer drugs--which can cost 10 times as much as the
10 older ones--are worth the difference in price." Were you
11 aware of this study going on?
12 A Yes.
13 Q When did you first become aware of this study?
14 A I think I became aware of it shortly before it was
15 published, because psychiatrists such as Dr. Jeffrey
16 Lieberman, who is quoted later, when he made
17 presentations about the CATIE study, described a
18 comparison study that was going on in England, and that
19 was really about all I knew about it.
20 Q Okay. "The study," down to the fifth paragraph, "The
21 study, published in the Archives of General Psychiatry,"
22 and that's a good journal, isn't it?
23 A Yes.
24 Q That's a very reputable journal. Do you read that
25 journal routinely?
117

1 A Uh-huh. Yes, I do.
2 Q "Is likely to add to a growing debate about prescribing
3 patterns of antipsychotic drugs. A U.S. government study
4 last year found that one of the older drugs did as well
5 as newer ones, but at the time, many American
6 psychiatrists warned against concluding that all the
7 older drugs were as good."
8 "Yesterday, in an editorial accompanying the
9 British study, the lead researcher in the U.S. trial
10 asked how an entire medical field could have been misled
11 into thinking that the expensive drugs, such as Zyprexa,
12 Risperdal, and Seroquel, were much better."
13 Quote, "'The claims of superiority for the
14 [newer drugs] were greatly exaggerated,'" unquote, "wrote
15 Columbia University psychiatrist Jeffrey Lieberman.
16 'This may have been encouraged by an overly expectant
17 community of clinicians and patients eager to believe in
18 the power of new medications. At the same time, the
19 aggressive marketing of these drugs may have contributed
20 to this enhanced perception of their effectiveness in the
21 absence of empirical information,'" unquote. He's
22 talking about some of your work, isn't he, Dr. Schulz?
23 MS. AHMANN: Object, lack of foundation.
24 BY DR. BARDEN:
25 Q He's talking about "The claims of superiority for the
118

1 [newer drugs] were greatly exaggerated," and he's --
2 MR. ALSOP: Objection on the basis in
3 foundation.
4 MR. HUTCHINSON: Same.
5 THE WITNESS: I don't have any idea.
6 BY DR. BARDEN:
7 Q Were you one of the people making claims of superiority
8 for the newer drugs?
9 MR. HUTCHINSON: Same objection.
10 MR. ALSOP: Same objections.
11 MS. AHMANN: Yeah.
12 THE WITNESS: I have given a number of talks
13 over the years as first clozapine and then other atypical
14 agents have come out. I've showed data from those
15 studies. The data I generally show is the pivotal trials
16 that led to the FDA approval of the medications, and I
17 will discuss during my talks that in the absence of
18 movement disorder and a 90 percent, nearly 90 percent
19 reduction in the onset of tardi dyskinesia, plus the
20 demonstrated improvement in neuropsychological testing
21 results, that on balance, the atypical antipsychotic
22 medications are useful in treating schizophrenia.
23 BY DR. BARDEN:
24 Q So you don't agree with Dr. Jeffrey Lieberman that "'The
25 claims of superiority for the [newer drugs] were greatly
119

1 exaggerated?'"
2 A I don't agree with that statement.
3 Q Is there a pattern in these? You don't agree with the
4 past president of the APA; you don't agree with Steve
5 Hyman, the head of NIH; you don't agree with
6 Professor Pope, who is the only psychiatrist in the world
7 to be in the half of one percent most cited in psychiatry
8 and neuroscience; you don't agree with Dr. Hudson; you
9 don't agree with a lot of these people. Do you feel like
10 your opinions on these issues are unusual?
11 MR. HUTCHINSON: Object to that as
12 argumentative.
13 MR. ALSOP: I'll join.
14 MS. AHMANN: Join.
15 MR. HUTCHINSON: Irrelevant, lacking in
16 foundation, misleading, misstatement of the evidence, and
17 inappropriate.
18 MR. ALSOP: It's vague also. But go ahead,
19 Doctor, if you can answer that question, go ahead.
20 THE WITNESS: My response to your question
21 is that the people you've mentioned, I all know. I know
22 them all. I know Steve, I know Steve Sharfstein. And I
23 think they're good doctors and good psychiatrists. You
24 pointed out a sentence or two of some things that they've
25 commented on, and I have not agreed with those
120

1 statements, and I don't think that puts me in the
2 position of being either argumentative or out of the
3 mainstream of psychiatry. I really don't like being
4 characterized by you that way.
5 DR. BARDEN: Okay. Do you want to state for
6 the record -- your objection that the question is
7 inappropriate is by itself inappropriate. That is not a
8 legal objection, and I'm not interested in people's
9 personal opinions about questions. So let's --
10 MR. HUTCHINSON: Well, I'm interested in
11 proper questioning and not --
12 DR. BARDEN: Keep your objections to legal
13 objections.
14 MR. HUTCHINSON: Not inappropriate --
15 DR. BARDEN: You have no right to make a
16 personal opinion like that in an objection, so don't do
17 it again.
18 MR. HUTCHINSON: I object. Counsel, just
19 go --
20 DR. BARDEN: You may make a legal objection,
21 but not a speaking objection about your personal feeling.
22 MR. HUTCHINSON: This isn't a contest of who
23 can talk the most or talk the fastest or talk the
24 loudest --
25 DR. BARDEN: It's a legal deposition.
121

1 MR. HUTCHINSON: -- or talk the longest.
2 DR. BARDEN: And you're rambling on about
3 personal opinions, which have nothing to do --
4 MR. HUTCHINSON: You're interrupting.
5 DR. BARDEN: You're giving --
6 MR. HUTCHINSON: You're not being fair to
7 the court reporter and you're not listening and giving me
8 a chance to speak. You're trying to overspeak me and
9 prevent me from making a record. I am interested in
10 proper questions, not argumentative, insulting questions,
11 and I thought the last one was, and I just made my
12 record. He was allowed to answer, and he did. If you
13 didn't like my objection, I understand, but I made my
14 objection and I stand by it.
15 DR. BARDEN: Okay, and in some states, you'd
16 be sanctioned for that. I don't think in Minnesota we do
17 that, but what you've just said is not a legal objection,
18 it is not appropriate. You may say asked and answered,
19 you may say vague and compound, you may make legal
20 objections, but what you just did is give a personal
21 speech, and it's not appropriate and it's holding up the
22 legal process.
23 MR. HUTCHINSON: Just interested in proper
24 questions being asked.
25 DR. BARDEN: And you are not given the right
122

1 to make that determination.
2 BY DR. BARDEN:
3 Q So we're on page 2 of 3. Talking about several older
4 studies that also found no difference between older drugs
5 and newer ones. Were you aware of the 2003 study done by
6 Robert Rosenheck, a psychiatrist at the Department of
7 Veterans Affairs?
8 A I'm sorry, where are we now?
9 Q Page 2 of 3?
10 A Yeah.
11 MR. ALSOP: Where?
12 BY DR. BARDEN:
13 Q Right here (indicating), about one-third down.
14 A Okay.
15 Q Of the bottom third. Do you see that? Were you aware of
16 that study in 2003?
17 A Now, I have an awareness of that study. I am aware of
18 the conduct of it and of those results.
19 Q Okay, and you were aware of that prior to or during the
20 time that Dan Markingson was in your -- was in the CAFE
21 study on which you were a coinvestigator, correct?
22 A Yes.
23 Q What is the percentage of patients taking Seroquel that
24 drop off of use, stop taking it?
25 MR. ALSOP: Object on the basis of
123

1 foundation, speculative. Go ahead.
2 MS. AHMANN: Same objection.
3 BY DR. BARDEN:
4 Q Let me back up. As a psychiatrist that does research in
5 this area and as someone who's given talks and as a
6 consultant to AstraZeneca, do you have to speculate on
7 the percentage of patients that discontinue use of
8 Seroquel?
9 MR. ALSOP: It's now argumentative.
10 THE WITNESS: Well, first of all, I'm not
11 sure which question are we working on now?
12 BY DR. BARDEN:
13 Q Do you know the percentage of patients that refuse to
14 continue taking Seroquel in drug trials?
15 MR. ALSOP: Same objections. Go ahead,
16 Doctor.
17 THE WITNESS: My best answer to that is, in
18 taking a look at the study Dr. Lieberman did, known as
19 the CATIE study, in which dropping out of the study was,
20 dropping out or choosing not to continue or having the
21 doctor say not to continue, a substantial number of
22 patients on all the medications in the study had
23 discontinued by about the seven- to nine-month mark.
24 So I can't quantify my answer, but just to
25 point out that one of the things discussed about the
124

1 CATIE study, which I think you have there in your lap, is
2 the surprise to the field of how frequently patients are
3 stopping medicines and switching to other medicines --
4 BY DR. BARDEN:
5 Q But --
6 A -- Seroquel included.
7 Q Was there any difference in the discontinuation rates
8 between those medicines?
9 A Yes, there was. The atypical antipsychotic medication,
10 olanzapine, had a statistically significant advantage
11 over all of the other medicines tested.
12 Q In fact, the highest discontinuation rate was Seroquel,
13 correct?
14 A I can't remember whether it was the highest or whether
15 ziprasidone was.
16 DR. BARDEN: Well, let's mark this.
17 Exhibit I?
18 MS. AHMANN: Do you have copies?
19 DR. BARDEN: We're not going to talk about
20 it for more than, just one number.
21 (Schulz Deposition Exhibit I marked for
22 identification.)
23 BY DR. BARDEN:
24 Q If you could identify that for the record.
25 A This is a copy of an article from the New England Journal
125

1 of Medicine dated September 22, 2005. The title of the
2 article is Effectiveness of Antipsychotic Drugs in
3 Patients with Chronic Schizophrenia, and the lead author
4 is Dr. Jeffrey Lieberman.
5 Q Okay. I just want to look at the first page there.
6 Yeah, here we are. "Results. Overall, 74 percent of
7 patients discontinued the study medication before 18
8 months," and then it gives various percentages of
9 discontinuation. Do you see, 82 percent?
10 A Yes, yes, I do.
11 Q And that's for Seroquel.
12 A That's correct.
13 Q And yet it still has the highest market share due to, as
14 Dr. Lieberman said, quote, "the aggressive marketing of
15 these drugs," unquote.
16 MS. AHMANN: Objection, lack of foundation,
17 speculation.
18 MR. ALSOP: Object, lack of foundation,
19 speculative.
20 THE WITNESS: I don't know the connection
21 between this and Dr. Lieberman's statement.
22 BY DR. BARDEN:
23 Q To the best of your knowledge, is there an aggressive
24 marketing campaign for Seroquel?
25 MS. AHMANN: Object --
126

1 MR. ALSOP: Foundation, it's irrelevant.
2 MS. AHMANN: -- foundation.
3 THE WITNESS: If you can help me. Compared
4 to what?
5 BY DR. BARDEN:
6 Q Do you have any idea how much marketing funding is spent
7 by AstraZeneca marketing Seroquel?
8 A No.
9 Q You've never asked?
10 A No.
11 Q Have you ever calculated how much money AstraZeneca
12 stands to lose if states and institutions go back to
13 using the older antipsychotic drugs?
14 MS. AHMANN: Same objection.
15 THE WITNESS: No, I've never calculated
16 that.
17 BY DR. BARDEN:
18 Q Certainly be in the billions of dollars each year,
19 correct?
20 MS. AHMANN: Lack of foundation.
21 MR. ALSOP: I'll join, speculative. It's
22 also repetitious. Go ahead.
23 THE WITNESS: I'm slightly confused, because
24 you showed me an exhibit here, you said it states, so.
25
127

1 BY DR. BARDEN:
2 Q I'm sorry?
3 A So I guess you're meaning if --
4 Q If the market --
5 A Well, you mean worldwide.
6 Q Yeah.
7 A If the world changed.
8 Q I think that's fair.
9 A I think that if the world changed, that there would be a
10 big impact on the pharmaceutical companies that make
11 atypical antipsychotics.
12 DR. BARDEN: I think let's go off the record
13 now.
14 (Lunch recess taken at 12:20 p.m.)
15 * * * *
16 (Proceedings continued at 1:10 p.m.)
17 DR. BARDEN: We're back on the record?
18 Great.
19 BY DR. BARDEN:
20 Q Good afternoon.
21 A Good afternoon.
22 DR. BARDEN: Does everyone have a copy of
23 this? It's the UM IRB, starts 2811, Bates stamped 2811.
24 MR. ALSOP: Yeah, I'll mark it, get it for
25 her.
128

1 (Schulz Deposition Exhibit J marked for
2 identification.)
3 BY DR. BARDEN:
4 Q Let me just ask you a series of questions first.
5 Dr. Schulz, have you ever dealt with the
6 University of Minnesota IRB?
7 A Yes, I have.
8 Q What's your understanding of what the letters IRB mean?
9 A Institutional Review Board.
10 Q And what is the purpose of the Institutional Review
11 Board?
12 A The purpose is to assess research and to make sure that
13 there is a provision for informed consent and safety of
14 the research subjects.
15 Q Okay. If someone from the IRB board said that their role
16 was just to make sure a plan was in place, would you
17 agree with that or not?
18 MR. ALSOP: Object as vague.
19 THE WITNESS: I'm not sure -- I don't
20 understand the question. I'm sorry.
21 BY DR. BARDEN:
22 Q Well, hypothetically, let's say someone from the IRB
23 board testified under oath that the IRB's job is not to
24 ensure safety, but just to make sure that a plan is in
25 place for each study.
129

1 MR. HUTCHINSON: I'm sorry. Objection, lack
2 of foundation.
3 MR. ALSOP: I'll join. It's also vague. Go
4 ahead.
5 THE WITNESS: My experience with members of
6 our IRB, that sounds pretty superficial, and my
7 experiences in talking with people at the IRB is that
8 their understanding of what they do is what I previously
9 stated.
10 BY DR. BARDEN:
11 Q Yeah, I mean, it's pretty well-known in the biomedical
12 field that the role of the IRB is to ensure, e-n-s-u-r-e,
13 patients are protected, right?
14 MR. HUTCHINSON: Object to the form.
15 THE WITNESS: I think I already said what I
16 thought an IRB should do.
17 BY DR. BARDEN:
18 Q Okay. If you look at page, the first page of what's been
19 marked as Exhibit J, it's UM IRB 2811. Under policy,
20 "University of Minnesota Principal Investigators (P.I.)
21 are responsible for the treatment of human subjects." Is
22 that your understanding, Dr. Schulz?
23 A If you give me a second. I understand you're asking me
24 the question. So, yes, that is my understanding, and
25 this is a relatively new document for our university,
130

1 September 2006.
2 Q Uh-huh. Is it your understanding that this is any change
3 from previous?
4 A I think that there were changes. I can't tell you all of
5 them with this delegation of responsibility.
6 Q But it's always been the case that PIs are responsible
7 for the treatment of human subjects, correct? That
8 certainly hasn't changed, has it?
9 A Well, I wouldn't think so, but I, just in taking a look
10 at what you're directing me to, this document of 2006,
11 and saying hasn't this been the way it's always been, I
12 can't say for sure.
13 Q Can you, as a psychiatrist who has done research, can you
14 point to me any particular time period in the last 30
15 years where principal investigators were not the persons
16 responsible for the treatment of human subjects?
17 MR. ALSOP: Object to multiple question and
18 vague. Go ahead.
19 THE WITNESS: My understanding of what the
20 IRB asks the principal investigator to do is to be
21 overall in charge of the conduct of the study, and that
22 includes the science and the informed consent or the
23 safety of the people who are in the study.
24 BY DR. BARDEN:
25 Q Okay, and that would have been Dr. Olson in the study
131

1 involving Dan Markingson, correct, he was the PI?
2 A Dr. Olson was the PI at our site.
3 Q Okay, and you were assigned coinvestigator, correct?
4 A Correct.
5 Q I know I've asked you this before, but I don't know if
6 I've asked you this particular specific question. During
7 the time that Dan Markingson was in the CAFE study and
8 during the time that you were assigned coinvestigator on
9 that study, what, if any, duties did you have to ensure
10 the protection of human subjects in that study?
11 MR. ALSOP: I would agree it's repetitious,
12 it was discussed at length this morning, but go ahead,
13 Doctor.
14 THE WITNESS: I think I said earlier, and
15 I'll say again, that I was available there for Dr. Olson
16 in case he needed anybody to fill in for ratings, etc. I
17 did not participate in any meetings Dr. Olson held with
18 his staff to discuss the studies. And if I had heard
19 about something that was concerning, I would have talked
20 with, I would have first approached Dr. Olson and talked
21 with him about it.
22 BY DR. BARDEN:
23 Q Do you think you'd had any other duties other than what
24 you've discussed so far on the record?
25 A Including what I said this morning and what I said this
132

1 afternoon?
2 Q Correct.
3 A No.
4 Q Have you had any classes or training in the duties of a
5 coinvestigator on a drug trial study?
6 A As I discussed earlier, the University of Minnesota has a
7 responsible conduct research class, not specific to
8 coinvestigators, but the conduct of research, and I took
9 that course and was certified.
10 Q Okay. Did Dr. Olson ever come to you and say that he had
11 written to a court that Dan Markingson lacked capacity to
12 make informed judgments, but that he had signed him in as
13 a subject in the study? Did Dr. Olson ever comment,
14 present that issue to you?
15 MR. HUTCHINSON: This is repetitive.
16 MR. ALSOP: Objection, repetitious, but go
17 ahead one more time.
18 THE WITNESS: I don't recall any
19 conversations like that.
20 BY DR. BARDEN:
21 Q Did Dr. Olson ever come to you discussing potential
22 coercive effects on court orders of any of your subjects?
23 MR. ALSOP: Objection, repetitious.
24 THE WITNESS: No, he did not.
25
133

1 BY DR. BARDEN:
2 Q Do you have any special policies or procedures at the
3 University of Minnesota for patients, for research
4 subjects who have been coercively influenced by court
5 orders?
6 MR. ALSOP: Object as argumentative,
7 misstating the facts, and foundation, but go ahead.
8 MR. HUTCHINSON: Join.
9 THE WITNESS: My understanding is that a
10 patient who is committed still retains the ability to
11 consent for certain issues. In other words, a patient
12 may be committed to our hospital, and still voluntarily
13 consent to receive a medication treatment, as an example.
14 BY DR. BARDEN:
15 Q Patients receiving neuroleptics supposed to sign a form?
16 A Our hospital does have a policy that, there is a sheet
17 that they are supposed to sign that describes the side
18 effects of medications so that they understand it.
19 Q Is there any special form to be signed for the use of
20 neuroleptics, other than what you've discussed so far?
21 A That's what I thought I just described.
22 Q Did Dr. Olson ever inform you that he did not have Dan
23 sign that when he used neuroleptics on him in the
24 hospital?
25 MR. ALSOP: Object as repetitious. Go
134

1 ahead.
2 MR. HUTCHINSON: Same.
3 MR. ALSOP: Go ahead, you can answer.
4 THE WITNESS: I understand what happens, is
5 unfortunately --
6 MR. ALSOP: You hear me.
7 THE WITNESS: Yeah. What was the question
8 again?
9 BY DR. BARDEN:
10 Q Did Dr. Olson ever inform you that he treated Dan
11 Markingson with neuroleptics in the hospital without
12 having him sign such a form?
13 A No, he did not ever tell me that.
14 Q Would you have concerns, if he had in fact done that?
15 A I would want to know more about it, yes.
16 Q Would those kinds of violations of procedures be
17 something you would report, or would you discuss it
18 personally with Dr. Olson?
19 MR. ALSOP: Object to the form of the
20 question as plural, and misstating the facts, and it's
21 duplicative, but go ahead.
22 MR. HUTCHINSON: I'll join. Lacking
23 foundation.
24 DR. BARDEN: Okay. I think that's fair.
25
135

1 BY DR. BARDEN:
2 Q It happened one time. He put him on neuroleptics, but
3 never got the form signed. Would that be something you
4 would report or discuss with him personally?
5 MR. HUTCHINSON: Well, counsel, are you
6 asking him to assume this witness became aware of that?
7 Because I thought he said he didn't, Dr. Olson didn't
8 tell him that. That's where I'm a little lost.
9 DR. BARDEN: Okay, and I'm having trouble
10 with your speaking objections, again, which you're
11 actually coaching the witness, which are highly improper.
12 If you have -- the proper objection for that is lacks
13 foundation, calls for facts not in evidence, and that is
14 all that you get to say. You don't get to coach the
15 witness on what he said or what his memory was or whether
16 reported. That's not appropriate. Let's stick to the
17 legal objections. Okay?
18 MR. HUTCHINSON: Maybe you intend to ask
19 misleading questions, but I thought the question --
20 DR. BARDEN: Then you get to bring that up
21 with the court. You can state it states facts not in
22 evidence, you can say misleading, but you can't give a
23 speech that informs the witness what your theory of the
24 question is. That's highly inappropriate. Thank you.
25 MR. HUTCHINSON: Read -- you're going to
136

1 restate it or do you want it read back, the question?
2 DR. BARDEN: I'm just going to go and ask
3 questions, and I hope you're just going to use legal
4 objections.
5 BY DR. BARDEN:
6 Q You mentioned that you would find it a concern if a
7 psychiatrist in your department had treated a patient
8 with neuroleptics, but not had them sign the neuroleptic
9 form, correct?
10 A I did.
11 Q But what level of concern would you have? Would you
12 report the doctor to someone or would you just speak to
13 them privately?
14 MR. ALSOP: Object as vague as to report,
15 but go ahead.
16 THE WITNESS: I'd like to answer the
17 question by describing the process on the wards, where
18 the faculty at the University of Minnesota are one of the
19 groups admitting.
20 So patients can be referred in to one of
21 our, one of the University of Minnesota Medical Center at
22 Fairview wards. When they're admitted, they can't go
23 onto the ward until the staff has either, in the
24 emergency room or as soon as they come to the ward,
25 signed a consent form consenting to be in treatment, or
137

1 if they were hypothetically committed to us.
2 There are meetings every day, and the
3 nursing staff who meet with the doctors, in my experience
4 on those wards, say you've prescribed an antipsychotic
5 medication, we have to now obtain the neuroleptic consent
6 form.
7 So how it turned out that, your description,
8 that Dan did not sign this form is concerning to me,
9 because of the daily team meetings with the head nurse,
10 the social worker, the psychiatrist, the resident, and
11 that my experience is you go through this every day on
12 every admission. So I don't know how it happened. And
13 hearing about it now, I would want to look into how could
14 a person not have signed the form. You know, there may
15 be other circumstances I'm not aware of.
16 But follow your question, yes, that does
17 concern me and I would want to look into it further, and
18 it would depend on what happened as to whether it would
19 come to some committee or be handled by the medical
20 director of that unit and Dr. Olson.
21 BY DR. BARDEN:
22 Q How would a faculty member or staff person file a
23 complaint if they noticed something like that? What
24 would be the proper procedure?
25 A Sure.
138

1 Q During the time Dan Markingson was in the CAFE study and
2 being treated at Fairview.
3 A Well, as we discussed this morning, there are forms, and
4 there were forms, paper forms, on the unit during the
5 time of late 2003 and 2004, and if a staff member, nurse,
6 social worker, psychiatric tech, had a concern that
7 something had not gone correctly, they would fill that
8 form out and turn it in to the hospital administration,
9 Fairview Behavior Services. They would examine it, and
10 they would either direct the complaint back to the unit
11 and have the medical director of the unit meet with the
12 person who brought the complaint or person that brought
13 the complaint, the head nurse, and if the complaint was
14 about a psychiatrist, meet with them and solve the
15 problem.
16 Q So that was the system in place --
17 A Correct.
18 Q -- but the audit we discussed indicated that a very
19 significant percentage of the people working on those
20 units didn't feel like they'd be protected from
21 retaliation, if they complained, correct?
22 MR. ALSOP: That's argumentative and a
23 misstatement of the facts in his prior testimony in this
24 case when you asked him about those issues.
25 MR. HUTCHINSON: Same, and lack of
139

1 foundation.
2 MR. ALSOP: Go ahead, Doctor.
3 THE WITNESS: So the process I just
4 described to you is a University of Minnesota
5 Medical Center process for work on our wards. The audit
6 that we discussed earlier was a questionnaire of the
7 secretaries, the grant accountants, and the academic
8 faculty within our faculty area, and did not address at
9 all the scenario you described regarding the ability of
10 people working on the wards to make a complaint to the
11 hospital about what was going on.
12 So, therefore, none of the people on the
13 wards were the object of this audit.
14 BY DR. BARDEN:
15 Q Has there been a survey audit done on those hospital
16 wards?
17 A I don't know.
18 Q Do you have any reason to believe it would be any
19 different or maybe even much worse than it was in an
20 academic setting?
21 MR. ALSOP: Object, argumentative.
22 DR. BARDEN: I'm sorry. Let me rephrase
23 that.
24 BY DR. BARDEN:
25 Q What, if anything, information do you have indicating
140

1 that an audit done in the wards would provide any
2 different data whatsoever than the one done in the grant
3 office?
4 A I'm not aware of --
5 MS. AHMANN: Objection, lack of foundation.
6 MR. HUTCHINSON: Same.
7 THE WITNESS: I'm not aware of any audit
8 performed in a similar process to the one the
9 University of Minnesota does for its academic faculty and
10 staff.
11 BY DR. BARDEN:
12 Q Are you aware of any widespread knowledge in the medical
13 field that nursing staff often feel that if they file
14 complaints, they'll suffer serious retaliation?
15 MR. ALSOP: Speculative, lacking foundation.
16 Go ahead.
17 MR. HUTCHINSON: Same.
18 THE WITNESS: I'm not aware of any
19 literature, but it's certainly not been my experience at
20 University of Minnesota Medical Center.
21 BY DR. BARDEN:
22 Q Ever had any nurse mention to you that they were worried
23 about retaliation if they reported a doctor for
24 something?
25 A I have not, no.
141

1 Q Look at page, the next page of what's been marked as
2 Exhibit J.
3 A What number is that?
4 MR. ALSOP: Just next page.
5 DR. BARDEN: Just very next page.
6 MR. ALSOP: In front of you.
7 BY DR. BARDEN:
8 Q It's UM IRB 2799. It says, "Research Involving Human
9 Participants Unable to Consent-Surrogate Consent."
10 A I'm still not caught up with you. Is this page 1 of 3?
11 MR. ALSOP: Yes.
12 THE WITNESS: Where are we looking?
13 BY DR. BARDEN:
14 Q We're looking at under policy. Second sentence,
15 "Research involving subjects who are mentally ill or
16 subjects with impaired decision-making capacity warrants
17 special attention." Would you agree with that sentence?
18 A Yes.
19 Q Did you know that Dr. Olson had signed a form to a court
20 saying that Dan Markingson was mentally ill and lacked
21 capacity within a few days of when he had him sign an
22 informed consent form?
23 MR. ALSOP: Counsel, this is about the
24 fourth time you've asked that question, and he'll answer
25 one more time and not again. Go ahead.
142

1 THE WITNESS: I was not aware of that, no.
2 BY DR. BARDEN:
3 Q Is there any system in place in the Department of
4 Psychiatry to catch patients like that, that is, patients
5 who have been signed up for informed consent, but, in
6 fact, there is medical information directly in their
7 current file saying they lack capacity for informed
8 consent? What, if any, systems do you have in place to
9 catch that mistake?
10 MR. ALSOP: Object as argumentative,
11 misstatement of the facts.
12 MS. AHMANN: Join.
13 MR. HUTCHINSON: Same, lack of foundation.
14 THE WITNESS: So to answer your question, my
15 understanding is that you're asking about whether
16 Dr. Olson indicated that the patient was incompetent to
17 provide informed consent.
18 BY DR. BARDEN:
19 Q That he lacked capacity, was mentally ill, was not aware
20 that he was mentally ill, etc., yes.
21 MR. ALSOP: And the question is how you
22 catch that issue?
23 DR. BARDEN: Yeah.
24 MR. ALSOP: Okay.
25
143

1 BY DR. BARDEN:
2 Q What is in place when you have a medical chart and
3 documents to a court saying this patient believes that
4 his family members are lizards, for example, or he's in a
5 Satanic cult, I mean, that he's grossly psychotic, and
6 they use the phrase lacks capacity, and they say that he
7 should be petitioned to a court for commitment and they
8 say that he's grossly psychotic, and then he's signed
9 into a research study on his own signature? Was there a
10 system in place during this timeframe, that is, December
11 of 2003, was there a system in place that would have
12 caught that error; and, if so, what was the system?
13 MR. ALSOP: Assumes facts not in evidence as
14 to the last comments, it's multiple and argumentative,
15 but go ahead.
16 MS. AHMANN: Join.
17 MR. HUTCHINSON: Same, and lacks foundation.
18 THE WITNESS: So the investigator, Dr. Olson
19 in this case, needs to pass the responsible conduct to
20 research course we've discussed. The people helping
21 Dr. Olson, the project coordinators or research
22 assistants, have courses in certifications they need to
23 pass on the same material. In addition to that,
24 Dr. Lieberman, who we discussed earlier, the head of the
25 CATIE study published in the New England Journal of
144

1 Medicine, used the same clinical research organization
2 that the NIMH certified to also run the CAFE study, and
3 they closely, to my understanding, closely monitored this
4 study.
5 So there were research assistants, project
6 coordinators, as well as monitors for the study in place,
7 in my opinion, in order to make sure that the protocol
8 was being followed.
9 BY DR. BARDEN:
10 Q And isn't it in fact the case, Doctor, that regardless of
11 what kind of system you have like that, if you had a
12 psychiatrist who had a large financial and professional
13 interest in aggressively recruiting subjects and was
14 under a lot of time pressure to recruit subjects, and if
15 they had decided to obtain those subjects by using the
16 coercive power of the legal system to obtain a subject,
17 that system, a system you're describing, couldn't catch
18 all those doctors, could it?
19 MR. ALSOP: Object as a multiple question,
20 argumentative, misstates the facts. Go ahead, Doctor.
21 MS. AHMANN: Same.
22 MR. HUTCHINSON: Join, and lacks foundation.
23 MR. ALSOP: Go ahead, if you can answer it.
24 THE WITNESS: You've described a scenario
25 that I can't agree to, but I will comment that Quintiles,
145

1 to my understanding, developed an outstanding reputation
2 through their contact at the CATIE study that you showed
3 me, and that they have no connection with Dr. Olson, and
4 would want to make sure that the study was run properly.
5 They don't get any reward one way or the other. They
6 just want to make sure the study is run.
7 BY DR. BARDEN:
8 Q But Dr. Olson's contract, he gets paid by the subject he
9 recruits, correct?
10 A No, he doesn't.
11 Q The study does. There is a $16,000 payment per
12 recruitment, correct?
13 A Well, you have two questions going. You have doesn't
14 Dr. Olson make money, and then you describe the subject
15 of the study. So if you'd like to break it down, I'll be
16 happy to do my best to answer.
17 Q Well, let's talk about that. You're an academic
18 psychiatrist, correct?
19 A I am.
20 Q And so is Dr. Olson, correct?
21 A That's correct.
22 Q And your reputation depends upon publishing, doesn't it?
23 A Not all -- let me just back up a second. At the
24 University of Minnesota, there are multiple academic
25 tracks. Some faculty members, no matter what the
146

1 clinical department at the medical school, are in a
2 clinical scholar track, for which publication -- can I
3 finish?
4 Q Yes, but I'm going to move to strike as nonresponsive,
5 and then we'll just start over.
6 MR. ALSOP: Why don't you let him finish
7 answering his question. If he doesn't like it, he can
8 make his objection. But go ahead.
9 THE WITNESS: I believe you asked me about
10 whether his reputation is based on his ability to
11 publish, and I was describing that he was in an academic
12 track at the University of Minnesota for which
13 publications, per se, are not a necessary requirement for
14 his promotion.
15 DR. BARDEN: Move to strike as
16 nonresponsive.
17 BY DR. BARDEN:
18 Q I didn't ask you if they were necessary. Dr. Schulz, you
19 work in a university environment, correct?
20 A I do.
21 Q People in a university environment have their reputations
22 enhanced by publishing peer-reviewed research articles,
23 correct?
24 A No.
25 Q So you think that Dr. Olson's reputation is not enhanced
147

1 by publishing peer-reviewed research articles.
2 A Dr. Olson's overall reputation at the University of
3 Minnesota is based on his ability to take care of
4 patients, to teach, participate in research projects. He
5 has not been a person writing a lot of first authored
6 articles and has been an outstanding faculty member.
7 DR. BARDEN: Objection, move to strike as
8 nonresponsive.
9 BY DR. BARDEN:
10 Q You're telling me under oath that you think Dr. Olson's
11 reputation will not be enhanced by publishing
12 peer-reviewed journal articles?
13 MR. ALSOP: It's argumentative.
14 DR. BARDEN: I didn't say completely, I
15 didn't say it's the most important thing, I didn't say
16 it's necessary. We can play these word games all day.
17 MR. ALSOP: Yes, you can.
18 BY DR. BARDEN:
19 Q Isn't it true that every licensed health care provider
20 that works in an academic setting would rather publish
21 than not publish?
22 MR. ALSOP: Object on the basis of
23 foundation, argumentative, and repetitious. Go ahead.
24 MR. HUTCHINSON: Join.
25 MS. AHMANN: Join.
148

1 THE WITNESS: Well, I think to make it easy
2 and move ahead, Dr. Olson's reputation as a psychiatrist
3 would be improved if he were to publish in the medical
4 literature.
5 BY DR. BARDEN:
6 Q Now, let's go back to your resume for just a second, a
7 few things that I forgot to ask you. We had looked at
8 whether you'd ever published anything on medical ethics.
9 Do you remember that?
10 A Yes.
11 Q You talked about the Hastings Report, and we talked about
12 the fiduciary duties to patients briefly. Let me ask
13 you, have you ever published an article related to
14 unethical behaviors of researchers, have you ever
15 published anything on that whatsoever?
16 A I don't recall.
17 Q Have you ever published anything that relates in any way
18 to the history of misconduct by psychiatric researchers
19 or therapists?
20 A I don't recall publishing an article on that.
21 Q Have you ever published anything at all with regard to
22 the history of patient abuse in psychiatric research?
23 A Not that I'm aware of.
24 Q Are you aware of any famous litany of patient abuses in
25 psychiatric research?
149

1 MR. ALSOP: Object as vague and ambiguous
2 and irrelevant, but go ahead.
3 THE WITNESS: Could you restate the
4 question? I'm sorry, I just got distracted.
5 BY DR. BARDEN:
6 Q In the history of psychiatry, are you aware of some
7 significant patient abuses in research?
8 MR. ALSOP: Same objections. Go ahead.
9 THE WITNESS: Yes, I am.
10 BY DR. BARDEN:
11 Q Can you describe some of those for me?
12 A Well, the one that comes first to mind is the work of
13 Dr. Walter Freeman, psychiatrist who, pardon me, a
14 neurologist, not a psychiatrist, who perfected a
15 treatment that began in Europe called prefrontal
16 lobotomy, and he performed this treatment; and as the new
17 medications at that time were introduced during the
18 1950s, there were concerns brought about his continuing
19 to continue prefrontal lobotomy treatment now that newer
20 and psychotic medications treatments were available.
21 Q Freeman, he invented the ice pick procedure which let it
22 go rapidly, correct?
23 A I think I already stated he perfected a technique that
24 had been started in Europe.
25 Q By a psychiatrist. Do you know that person's name?
150

1 A Moniz. A Nobel Prize winner, so you were talking about
2 Nobel Prize winners.
3 Q Uh-huh. Is he the last psychiatrist to win the
4 Nobel Prize?
5 A No.
6 Q Who else?
7 A Eric Kandel from Columbia.
8 Q So other than lobotomies, can you tell me about some
9 other famous patient abuses in psychiatric research?
10 A None come to mind right now.
11 Q You're not aware of any LSD experiments, for example?
12 A The only vague memory I have is maybe 20 years ago going
13 to a symposium at APA in which the presenters talked
14 about wanting to reinitiate LSD research to better
15 understand how serotonin worked in the brain, and there
16 was discussion about the pros and cons of using LSD in
17 research.
18 Q Anything else?
19 A No.
20 Q You're not aware of any research involving so-called
21 repressed memories or multiple personality disorder?
22 A I'm not.
23 Q A number of psychiatrists lost their license over that?
24 You're not aware of that?
25 A No, I'm not.
151

1 Q Were you ever aware that there was a problem in the
2 psychiatric field with regard to multiple, so-called
3 multiple personality disorder?
4 A I think only from the newspaper articles or psychiatry
5 news, newsletters, about the difficulty of making the
6 diagnosis and, you know, certain legal issues that came
7 up regarding repressed memory, and that there were pretty
8 heated debates back and forth between clinicians about
9 that.
10 Q Are you aware of the multiple license revocations that
11 took place as a result --
12 A No, I'm not.
13 Q -- of all that? So on this document that we're looking
14 at, which has been marked Exhibit J, so you never
15 discussed with Dr. Olson applying for surrogate consent
16 for any of your subjects in the CAFE study, correct?
17 MR. ALSOP: Object as vague and ambiguous,
18 but go ahead.
19 THE WITNESS: I'm sorry, I don't understand.
20 Could you restate it, maybe give it again?
21 BY DR. BARDEN:
22 Q We're looking at a document Research Involving Human
23 Participants Unable to Consent-Surrogate Consent.
24 A I'm sorry, where --
25 Q The same document we've been looking at, Exhibit J.
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1 A Yeah, I understand. Where are we looking now?
2 Q You see where "Investigators must apply to the IRB for
3 use of surrogate consent that is specific to the ...
4 study being reviewed." My questions's a very simple one.
5 Did you and Dr. Olson have a discussion about how to deal
6 with patients who were grossly psychotic, lacked
7 capacity, as to whether they would be able to join your
8 research study, how to, again, get informed consent from
9 someone who is psychotic at the time?
10 A No.
11 Q Did you have any methods or procedures in place to have a
12 surrogate give the capacity for such patients, that is,
13 patients who are currently grossly psychotic and lacked
14 capacity to give an informed consent?
15 MR. ALSOP: Object as repetitious. We've
16 discussed those already. But go ahead.
17 THE WITNESS: I do not believe -- well, I
18 know that it was not discussed.
19 BY DR. BARDEN:
20 Q Okay.
21 A I think that answers your question.
22 Q Since the IRB at the University of Minnesota knew that
23 these were subjects that had schizophrenia, right?
24 A That's correct.
25 Q And that schizophrenia is a mental illness, correct?
153

1 A That's correct too.
2 Q And that schizophrenia can result in people having
3 impaired decision-making capacity, correct?
4 A They can.
5 Q They can?
6 A Not always, but can.
7 Q And given that the IRB knew that, what, if any, steps did
8 they take to ascertain whether you were going to use
9 surrogate consent? Did they send you new requests for
10 information on that?
11 MR. ALSOP: Object as lacking in foundation.
12 THE WITNESS: No.
13 MR. ALSOP: Vague and ambiguous.
14 THE WITNESS: I don't know -- they didn't
15 send anything to me. I don't know if they sent anything
16 to Dr. Olson.
17 BY DR. BARDEN:
18 Q To the best of your knowledge, did the IRB conduct any
19 investigation whether some of your subjects needed a
20 surrogate in order to get informed consent?
21 MR. ALSOP: Same objection as to foundation.
22 MR. HUTCHINSON: Same.
23 THE WITNESS: I am not aware of any
24 investigation the IRB might have done.
25
154

1 BY DR. BARDEN:
2 Q Then on the next page, which is page UM IRB 2800, at the
3 very bottom, last sentence it says, "Under no
4 circumstances may subjects be forced or coerced to
5 participate." Do you agree with that?
6 A Yes, I do.
7 Q But you don't agree that a court stay of commitment,
8 which threatens to put someone in the state mental
9 hospital if they don't comply with a directive to enter a
10 treatment study, you don't think that's coercive, right?
11 MR. ALSOP: It's repetitious, asked and
12 answered at least three times. Go ahead.
13 MR. HUTCHINSON: Join, and lack of
14 foundation.
15 MS. AHMANN: Join.
16 THE WITNESS: I believe the patient had a
17 choice of either being in the study or continuing
18 treatment at another hospital.
19 BY DR. BARDEN:
20 Q Did you ever read the court order in this case?
21 A No.
22 Q So what's the foundation for your belief that he had a
23 choice, if you haven't read the court order?
24 A Let me back up. My belief is based on working on the
25 wards and the use of the stay of commitment procedure on
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1 those wards.
2 Q Okay. How many other patients do you have or have you
3 had in your studies who was, A, court-ordered to follow
4 the treatment recommendations of their treater; and B,
5 had a treater that recommended the CAFE study only? How
6 many patients have you seen like that, had a court order
7 to follow the recommendations of the treatment team, the
8 treatment team said you're going into CAFE?
9 A I'm not aware of any other patients in the CAFE study
10 that that happened to.
11 Q Look at -- continuing on what's been marked as Exhibit J,
12 if you look at the bottom right, there are some little
13 handwritten page numbers. If you go to page 6, I'm
14 sorry, 7 of that, the top right it says page 701, the
15 Bates number for this is UM IRB 2793. Do you see under E
16 where it says, "Does the consent form: Disclose
17 alternative procedures which may be advantageous to the
18 subject?"
19 A Yes, I do.
20 Q Okay. Have you read the consent form in this case?
21 A No, I haven't.
22 Q It discloses no alternative procedures whatsoever, does
23 it, Doctor?
24 MR. ALSOP: Lacking in foundation. He's
25 told you he hasn't seen the form.
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1 BY DR. BARDEN:
2 Q Have you ever seen the CAFE study informed consent form?
3 A No, I haven't.
4 Q So as a coinvestigator of this study and as someone who
5 is listed as ten percent, as a ten percent
6 coinvestigator, you never saw the informed consent form
7 for this study, correct?
8 MR. ALSOP: Have you heard the last three
9 answers when he says he hasn't seen it? Are you
10 confused? You don't have to answer that question. Don't
11 answer that question.
12 BY DR. BARDEN:
13 Q You didn't think you had a duty to look at the informed
14 consent form?
15 MR. ALSOP: It's argumentative. Go ahead,
16 you can answer that question.
17 THE WITNESS: No.
18 BY DR. BARDEN:
19 Q Have you, in your other studies, have you used informed
20 consent forms which disclosed no alternative treatments?
21 MR. ALSOP: Object as vague and ambiguous.
22 THE WITNESS: Seeing that you're asking me
23 about what I do, I would say that when I'm participating
24 in clinical research, if a person who is currently a
25 patient is referred, we say that you can participate in
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1 the research or you could go back to the community mental
2 health center and get treatment, or we will try to find a
3 psychiatrist for you. That's the way I work.
4 BY DR. BARDEN:
5 Q So you'd put that on the form?
6 A I wouldn't put it on the form. I would do it in the
7 discussion of the patient prior to initiating the
8 informed consent process.
9 Q Okay. I'm sorry. Let me try to make this a little
10 clearer then. We're looking at the University of
11 Minnesota IRB forms, correct?
12 A Well, I don't know that. You've kind of --
13 Q This is the University of Minnesota printout --
14 A I was trying to answer a question.
15 Q I'm sorry.
16 A Thank you.
17 Q But there was a confusion, because I was asking you about
18 a form, f-o-r-m, form, what's on the paper, and if we
19 look at what the page we've been looking at, which is
20 Bates No. UM IRB 2793, it says, "Does the consent form:
21 Disclose alternative procedures which may be advantageous
22 to the subject?" It doesn't talk about a discussion, it
23 doesn't talk about a clinical chitchat session; it talks
24 about the form.
25 My question to you was: When you're
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1 conducting your own research and you are responsible for
2 the form, do you put alternative treatments, risks, and
3 benefits on the form in that informed consent?
4 MR. ALSOP: It's a misstatement of this
5 document and what it contains, it's argumentative and
6 vague, but go ahead, Doctor.
7 MS. AHMANN: Join.
8 MR. HUTCHINSON: Join.
9 THE WITNESS: I think what I'd like to do to
10 answer, you've directed me to No. E, which obviously
11 appears to me to be part of a longer section. I'd like
12 to just look back --
13 DR. BARDEN: Objection, move to strike as
14 nonresponsive.
15 BY DR. BARDEN:
16 Q And I'm not asking you about what's on the form now. I'm
17 asking you, in your own research, you have informed
18 consent forms, correct?
19 A That's correct.
20 Q Do you put alternative procedures, treatments, benefits,
21 and risks of alternatives, on your consent form or not?
22 A Well, I'm awfully -- I think I am. I think I do.
23 Q And those forms would be available, would they not; they
24 would be something that the University holds onto?
25 MR. ALSOP: Object to as vague and
159

1 ambiguous, but go ahead.
2 BY DR. BARDEN:
3 Q Well, let me ask you this: As a PI in some studies, how
4 many years do you have to keep informed consent forms for
5 drug studies.
6 A I don't know for sure, but five or seven.
7 Q So then you would have several studies on which you are
8 currently involved and which you have those forms
9 currently stored, correct?
10 MR. ALSOP: That's a misstatement of his
11 prior testimony, go ahead.
12 THE WITNESS: I'm not sure there is several.
13 I don't know how many there are.
14 BY DR. BARDEN:
15 Q How many studies have you been a PI in in the last five
16 years?
17 A I'm thinking of two or four.
18 Q Okay, so you would have these, at least have the forms
19 for those studies?
20 A Yes, that's correct, that's right. And seeing as the --
21 DR. BARDEN: Objection. There is no
22 question before the witness.
23 MR. ALSOP: Go ahead and --
24 BY DR. BARDEN:
25 Q Let's go to the next page, it's page, look at the bottom
160

1 right, it says 8, UM IRB 2786. Under policy, again, this
2 is University of Minnesota IRB site, is under consent
3 process and under policy, do you see right in the middle
4 of the page, it says, "In reviewing a proposed research
5 study, the IRB determines if the setting, timing, and
6 procedures for soliciting informed consent are acceptable
7 and whether the consent process should be monitored."
8 Is it your understanding that that's
9 accurate, that that is the IRB policy of the
10 University of Minnesota?
11 A Yes.
12 Q Okay, and then it says in the next paragraph, "Under the
13 regulatory requirements the consent process should
14 fulfill these attributes," and we're looking, I'm looking
15 at the middle one that says, "The consent process
16 minimizes the possibility of coercion or undue
17 influence." Do you see that?
18 A Yes, I do.
19 Q Do you agree with that?
20 A Yes, I do.
21 Q Do you know what a HIPAA form is?
22 A Well, I think I know what HIPAA is, but I'm not sure what
23 you mean.
24 Q Okay. What's your understanding of HIPAA?
25 A HIPAA, my understanding is regulations related to the
161

1 protection of the privacy of a patient.
2 Q Are there HIPAA forms that must be signed by research
3 subjects?
4 MR. ALSOP: Objection, vague and ambiguous,
5 but go ahead.
6 THE WITNESS: My understanding is yes.
7 BY DR. BARDEN:
8 Q Okay. Do you know if Dan Markingson signed any HIPAA
9 form in the CAFE study?
10 A I do not.
11 Q If I represented to you that he did not sign a HIPAA
12 form, would you be concerned about that?
13 MS. AHMANN: I'm going to object, lack of
14 foundation, misstatement.
15 THE WITNESS: If -- the answer to that is I
16 would be concerned, yes.
17 BY DR. BARDEN:
18 Q Okay. Did Dr. Olson ever come to you and say, whoops, we
19 never got a HIPAA form from Dan Markingson?
20 A No, he did not.
21 Q Have you read Dr. Olson's correspondence with regard to
22 this case to outside agencies?
23 A No, I haven't.
24 Q Have you ever read any other correspondence in which
25 Dr. Olson made false, deceptive, and misleading
162

1 statements to people outside the University?
2 A No.
3 MR. ALSOP: It's argumentative and
4 misstatement of the facts. He's answered.
5 BY DR. BARDEN:
6 Q Do you, when you're doing a study, do you distinguish
7 between consent to participate in research and consent to
8 treatment?
9 A Yes, I do.
10 Q Did Dr. Olson ever come to you and say, whoops, I didn't
11 distinguish between consent for treatment and consent for
12 research with Dan Markingson?
13 A No, he did not.
14 Q Do you know that he told us that he was Dan's treating
15 physician till the day Dan died?
16 A I didn't know he told you that.
17 Q Would that surprise you?
18 MR. ALSOP: It's now irrelevant, but go
19 ahead.
20 THE WITNESS: It would not surprise me.
21 BY DR. BARDEN:
22 Q Would it surprise you if he hadn't seen Dan more than
23 once or twice in months before Dan's death?
24 MR. ALSOP: It's argumentative, irrelevant,
25 and a misstatement of facts, but go ahead.
163

1 MS. AHMANN: Join.
2 MR. HUTCHINSON: Join.
3 THE WITNESS: That would surprise me.
4 BY DR. BARDEN:
5 Q Pardon?
6 A That would surprise me.
7 Q With a psychotic patient, a schizophrenic in a drug study
8 like this, how many times would you expect that patient
9 to be treated by a psychiatrist, whether it's the study
10 or whether it's an outside psychiatrist? An ongoing
11 schizophrenic, mentally ill person, how often should they
12 be seeing a psychiatrist?
13 MR. ALSOP: That is now a multiple question
14 in two different settings, it's vague and ambiguous,
15 lacking in foundation. Go ahead and answer if you can.
16 MS. AHMANN: Join.
17 MR. HUTCHINSON: Join in all those.
18 MR. ALSOP: You can answer that question.
19 THE WITNESS: Well, let me start by
20 describing to you what I perceive the standard of care
21 around the Twin Cities or the State of Minnesota to be.
22 The frequency of visits is, from what I hear from my
23 patients and community meetings I go to, is with a
24 psychiatrist probably seeing a schizophrenic patient
25 about four times a year. At the appointments of the
164

1 mental health centers are frequently 15 minutes in
2 duration with a psychiatrist and the psychiatrist then,
3 in working with the treatment staff, writes a
4 prescription and an appointment is made for the next two
5 to three month.
6 My feelings are, is that in our community,
7 if a person is having an emergency, they will, say,
8 frequently come to our behavioral evaluation center,
9 where we have two psychiatrists from University of
10 Minnesota Medical Center on duty, if there is a crisis,
11 and then if a change in the focus of care is needed, they
12 would call the attending or figure out what the treatment
13 plan would need to be after that.
14 DR. BARDEN: Move to strike all portions of
15 that response that are nonresponsive to the question, and
16 move to strike all parts of the witness's answer with
17 regard to, quote, standards of care, unquote, since he's
18 already testified he rarely does clinical work, or less
19 than ten percent of his time. And let me reask that.
20 MR. ALSOP: And I'm going to respond, I'm
21 going to respond.
22 MR. HUTCHINSON: Sounds like a speaking
23 objection.
24 MR. ALSOP: That sounds like a speaking
25 objection to me too. But my response is you asked him
165

1 how often do you expect a patient to be seen in this
2 community, and he responded to the question.
3 DR. BARDEN: And he responded far beyond the
4 question, and I'd move to strike those parts. That's
5 all.
6 MR. ALSOP: That's why I have to say then,
7 you don't have to go on any further.
8 DR. BARDEN: Uh-huh.
9 MR. ALSOP: That's entirely inappropriate.
10 BY DR. BARDEN:
11 Q So in your informed consent forms, do you disclose
12 conflicts of interest when you're doing research?
13 A What we do in our consent forms is disclose who the study
14 sponsor is. I don't think that I put in my consent forms
15 that I would consult for a company or give lectures.
16 Q Let's say, for example, the study -- or the individual
17 has a financial incentive to keep people coming back; the
18 longer the person stays in the study, the more money they
19 get from an outside agency, whether to them or their
20 university or their study or whatever. That's a conflict
21 of interest with the patient, isn't it?
22 MR. ALSOP: That's argumentative and
23 misstatement of the facts and multiple, but go ahead.
24 MS. AHMANN: And lack of foundation.
25 MR. HUTCHINSON: Join.
166

1 THE WITNESS: The statement you've made, in
2 my opinion, does not describe what happens at the
3 University of Minnesota, so I don't agree with -- so I'd
4 have to say no to the question.
5 BY DR. BARDEN:
6 Q So hypothetically, someone had a contract where they're
7 paid by the visit.
8 A Yup.
9 Q Either the university is paid or the institution is paid
10 or the individual is paid or the research study is paid.
11 A Can we stay with your first question?
12 Q No, no.
13 A You asked a question, and then you don't let me answer.
14 Q So there is a system in place where every time a patient
15 comes and completes a visit, there is money paid. Do you
16 understand that so far? Person visits, there is money
17 paid. If someone stays for 20 visits, there will be more
18 money paid than if they leave after two visits. There is
19 a financial incentive to keep the person in the study.
20 That's the hypothetical.
21 And then isn't that a conflict of interest
22 with patient care, where the physician does not have a
23 typical outside treating physician, does not have this
24 extra incentive from an outside, let's say a drug
25 company, for example, will be paying money per visit?
167

1 A For the work performed.
2 Q Yeah. Shouldn't that be disclosed on an informed consent
3 form, that kind of conflict of interest?
4 MS. AHMANN: I'm going to object. That was
5 a very multiple question, and I don't know what the
6 specific question is which he's expected to answer.
7 MR. HUTCHINSON: Same objection, lack of
8 foundation, and calls for a legal conclusion.
9 MR. ALSOP: I'll join. Go ahead.
10 THE WITNESS: My opinion is that here at the
11 University of Minnesota, there is a statement on the
12 consent form that describes who the sponsor of the study
13 is, and that those forms are approved by our
14 Institutional Review Board, and I do not believe there is
15 a conflict of interest in the scenario you described.
16 BY DR. BARDEN:
17 Q And the forms that are approved by your IRB do not
18 disclose whether they get paid by the visit, do they?
19 MR. ALSOP: Object on the basis of
20 foundation. He hasn't seen it.
21 DR. BARDEN: He's seen his own forms, he's
22 so testified.
23 MR. ALSOP: What forms are we talking about?
24 It's vague now.
25 DR. BARDEN: Talking about forms approved by
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1 the IRB.
2 MR. ALSOP: Vague as to forms, but go ahead.
3 BY DR. BARDEN:
4 Q Have you ever seen a form at the University of Minnesota
5 that disclosed that they had a financial incentive to
6 keep the subject in the study for a year, a full year?
7 A Let me say, it's a lot easier for you to answer if you
8 ask me a question, rather than ask other questions, etc.
9 So kind of stay on the tack, it's a lot easier for me.
10 Q Have you seen, since you've been at the University of
11 Minnesota since '99, have you ever seen an informed
12 consent form that disclosed when a company was paying by
13 the visit?
14 A No.
15 Q That is, they had a financial incentive to keep in the
16 study week after week?
17 MR. ALSOP: Now it's argumentative, assumes
18 fact not in evidence.
19 MS. AHMANN: Join.
20 MR. HUTCHINSON: Join.
21 MR. ALSOP: Go ahead.
22 THE WITNESS: Could you repeat your first
23 question?
24 MR. ALSOP: He said no to the first part of
25 question your question, and then you added something.
169

1 BY DR. BARDEN:
2 Q Have you ever seen an informed consent form at the
3 University of Minnesota that disclosed a financial
4 conflict of interest, in that the investigator or the
5 study or the university was paid by the visit?
6 A I think I just said no.
7 Q Okay.
8 A Haven't seen that.
9 Q Have you seen one where the speaking fees and honorariums
10 and consulting fees of the PI were disclosed in the
11 informed consent form?
12 A No. If I could take a break now, biological break now,
13 it would be helpful.
14 DR. BARDEN: Absolutely.
15 THE WITNESS: Thank you.
16 (Brief recess taken.)
17 BY DR. BARDEN:
18 Q Doctor, we're still on what's been marked as Exhibit J.
19 If you look at the bottom right corner, handwritten
20 number 11. Do you see that? That's 8.
21 A Okay.
22 Q There you go.
23 A Thank you.
24 Q If you look at the top third of the page, it says -- page
25 number UM IRB 2789. You see where it says, "Finder's
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1 fees: Sponsors sometimes offer investigators incentives
2 for recruiting subjects or conducting research on an
3 investigational drug or device manufactured by the
4 company. The incentive may be either a monetary fee or a
5 donation of equipment or materials. These incentives are
6 not permitted." Do you agree with that?
7 A Yes.
8 Q Are you aware of any incentives given by AstraZeneca to
9 the recruiters in this study?
10 A No.
11 Q Have you seen any of the e-mails back and forth
12 documenting the incentives given in this study?
13 A No.
14 MS. AHMANN: Object to lack of foundation.
15 He said he hasn't seen any.
16 BY DR. BARDEN:
17 Q Have you yourself ever received financial or other
18 incentives for recruiting subjects, that is, paid per
19 subject?
20 MS. AHMANN: Object to lack of foundation.
21 MR. ALSOP: Also irrelevant, but go ahead,
22 Doctor.
23 THE WITNESS: There is two parts to your
24 question. If you could break it in half for me, then I
25 could get started.
171

1 BY DR. BARDEN:
2 Q Okay. Have you ever received financial or other
3 incentives of food or gifts or anything else for
4 recruiting subjects?
5 A No.
6 Q And you've already testified, just to make sure the
7 record is clear, you're not aware, you are not aware that
8 this was going on in the CAFE study, correct?
9 MS. AHMANN: Object to lack of foundation.
10 THE WITNESS: Correct.
11 DR. BARDEN: Okay.
12 THE WITNESS: I don't know one way or the
13 other.
14 BY DR. BARDEN:
15 Q Next page, Bates No. UM IRB 2790, middle of the top,
16 "When the research involves adults unable to consent, the
17 IRB reviews and evaluates the proposed plan for
18 permission of legally authorized representative, using
19 the primary reviewers review sheet as a guide to
20 discussion." Is that your understanding of the policy of
21 the University of Minnesota IRB?
22 A Yes, it is.
23 Q But you're not aware of any subject in the CAFE study who
24 went through this procedure for adults unable to consent,
25 correct?
172

1 A That's correct.
2 Q Next let's look at page 14, bottom right, 14,
3 UM IRB 2704. See at the bottom there it says, "When some
4 or all of the subjects, such as children --
5 A I'm sorry, where --
6 Q -- prisoners --" right here (indicating).
7 A Where are we looking, when?
8 Q "When some or all the subjects, such as children,
9 prisoners, pregnant women, handicapped, or mentally
10 disabled persons, or economically or educationally
11 disadvantaged persons, are likely to be vulnerable to
12 coercion or undue influence, or for subjects found at
13 international sites, additional safeguards have been
14 included in the study and in the IRB review process, to
15 protect the rights and welfare of these subjects." Is
16 that your understanding of the University policy?
17 A Yes, it is.
18 Q Are you aware of any special safeguards that were
19 included in the CAFE study for Dan because he was listed
20 by his treating psychiatrist as lacking capacity?
21 A No.
22 Q Are you aware of any additional safeguards used for Dan
23 because he was under court order, that is, a stayed
24 commitment, to follow the treatment recommendations of
25 his physician, who is also the PI in the CAFE study? Are
173

1 you aware of any safeguards for him with regard to that?
2 That's a yes-or-no question. Then if it's yes, we can go
3 into detail.
4 A Okay. No, I'm not aware of any safeguards, in this
5 instance.
6 Q Okay. Look at the bottom of page No. 16. Move right
7 along here. This is Bates No. UM IRB 2657. See just
8 below the middle of the page, University of Minnesota
9 Role, Authority, Independence of the IRB --
10 A I apologize, I don't know where that is.
11 MR. ALSOP: I don't see where you are.
12 BY DR. BARDEN:
13 Q "The IRB is charged with ensuring that those individuals
14 participating in research are not subject to undue or
15 inappropriate risks, that participation remains
16 voluntary, and that the conduct of research is upheld as
17 a privilege." Is that your understanding of Minnesota's
18 policy?
19 A Yes, it is.
20 Q And so the word ensuring there, e-n-s-u-r-i-n-g, you
21 would agree with that, right?
22 A Yes.
23 Q You're not aware of any statements under oath by
24 Minnesota IRB officials that would be quite contradictory
25 to that, are you?
174

1 A No.
2 Q Okay. Page 19 on the bottom right. This is UM IRB 1316.
3 Very top of the page, "Subjects who are not able to give
4 informed consent may enroll in the research only if they
5 have a guardian who demonstrates the capacity and
6 willingness to consent for the subject. The subject will
7 then need to assent to participation." Is that your
8 understanding, that's the policy at University of
9 Minnesota?
10 A I'm sorry, I've gotten behind you. Could you point to
11 what you were reading?
12 Q Just the top part there (indicating).
13 MR. ALSOP: Would you read the first two
14 sentences you read?
15 BY DR. BARDEN:
16 Q Right at the top. "Subjects who are not able to give
17 informed consent may enroll in the research only if they
18 have a guardian who demonstrates the capacity and
19 willingness to consent for the subject. The subject will
20 then need to assent to participation." Is that your
21 understanding of your policy?
22 A Yes.
23 Q Okay.
24 DR. BARDEN: Let's mark this as Exhibit K.
25 MR. ALSOP: Which one is it, so I know what
175

1 I can give her?
2 DR. BARDEN: One on the front. Well,
3 actually I've got a copy for her.
4 MR. ALSOP: It's not one that's copied?
5 DR. BARDEN: It should be.
6 MR. ALSOP: Okay. This one (indicating)?
7 DR. BARDEN: No. August 6, 2002.
8 MR. ALSOP: It's not in this stack. I don't
9 have that myself either.
10 DR. BARDEN: Well, it should be in there
11 somewhere. He took it and copied it, and this is one of
12 the ones that he copied.
13 MR. ALSOP: Was that the second batch? Did
14 you pass out the second batch?
15 DR. BARDEN: I haven't passed out anything.
16 It might be in that stack right there (indicating).
17 MS. AHMANN: I have a copy if you --
18 MR. ALSOP: Is this the one?
19 (Schulz Deposition Exhibit K marked for
20 identification.)
21 BY DR. BARDEN:
22 Q So we're looking at what's been marked as Exhibit K. I
23 draw your attention -- this is a letter of August 6,
24 2002, from Carol Siegel, assistant director IRB, to
25 Timothy W. Olsen in ophthalmology. I'm just looking at
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1 the last paragraph on this first page, which is marked
2 UM IRB 0324, the first sentence, "The IRB would like to
3 stress that subjects who go through the consent process
4 are considered enrolled participants and are counted
5 toward the total number of subjects." Is that your
6 understanding of the University's policy?
7 A I'm not aware of that being a policy.
8 Q Okay. Has Dr. Olson ever claimed to you that people
9 aren't enrolled until they start taking the medication,
10 not when they go through informed consent?
11 A Let me make sure. Are we talking specifically -- which
12 study or what situation are we talking about regarding
13 that question?
14 Q Okay. It's true, is it not, that the University of
15 Minnesota policy is once a person goes through the
16 consent procedure, they are enrolled in the study?
17 MR. ALSOP: That's repetitious and a
18 misstatement of his last answer, but go ahead, Doctor.
19 THE WITNESS: Once a person signs the
20 informed consent, to the best of my understanding, they
21 are now enrolled in the study.
22 BY DR. BARDEN:
23 Q Thank you. And that is what the IRB letter says,
24 correct?
25 A Glad I agree with you.
177

1 Q Excellent. Have you ever heard Dr. Olson issue forth a
2 theory to you that's quite different than that, that is,
3 that people aren't enrolled until they start taking the
4 medication?
5 A No. I don't think I've ever heard him say that.
6 Q Okay. Did Dr. Olson ever claim to you that he got social
7 worker approval before enrolling, that is, getting
8 consent for Dan to enter the CAFE study?
9 A I'm sorry, I didn't quite follow. Could you ask the
10 question again?
11 Q Did Dr. Olson ever claim to you that he got Dan's social
12 worker's approval before enrolling Dan in the CAFE study?
13 A Which social workers are we talking about?
14 Q David Pettit, Dan's social worker, David Pettit?
15 A I don't know Mr. Pettit. I can't answer the question.
16 Q Okay. Have you ever read any letters in which Dr. Olson
17 claimed in writing that he got approval from Dan's social
18 worker to enroll him in the study?
19 A No.
20 Q Have you seen any documents indicating that David Pettit
21 was not even assigned to Dan until after Dr. Olson had
22 enrolled Dan in the study?
23 A No.
24 Q Hypothetically, if the court had ordered Dan to obey his
25 treatment team and social worker, and if Dr. Olson had
178

1 enrolled Dan in the study by getting his informed
2 consent, before David Pettit had even been assigned to be
3 his social worker, and then if Dr. Olson had written to
4 people that the consent was okay because he'd gotten
5 approval from his social worker first, you put those
6 things together, would you be concerned about that fact
7 matter?
8 MR. GROSS: Objection, lack of foundation,
9 multiple.
10 MR. ALSOP: It's a vague question. It
11 misstates the fact of this case, argumentative, lacking
12 in foundation. If you can answer that, go right ahead.
13 THE WITNESS: As I recalled, your question
14 began by saying hypothetically.
15 BY DR. BARDEN:
16 Q Uh-huh.
17 A So hypothetically, I would be concerned on what you just
18 described.
19 Q And the concern would be that a patient's rights may have
20 been violated?
21 A The concern would have been that the sequence of events
22 doesn't match what the doctor described.
23 Q So the doctor may be mistaken or lying or whatever.
24 A Something.
25 Q All right. Page, go to page 3 of what's been marked as
179

1 Exhibit K. This is the consent amendment for the CATIE
2 study. Have you ever seen this document before?
3 A No, I have not.
4 Q Were you aware that the U.S. Food and Drug Administration
5 issued a warning about increased risk of hyperglycemia
6 and diabetes in persons taking the atypical antipsychotic
7 drugs?
8 A Yes.
9 MS. AHMANN: Objection, foundation.
10 THE WITNESS: The answer is yes.
11 BY DR. BARDEN:
12 Q Yes, and you were aware that clinical trials using these
13 drugs then had to issue this consent amendment to warn
14 research subjects of this new risk?
15 A That's the usual procedure, yes.
16 Q Okay. Were you aware that this was not done in the CAFE
17 study until almost a month after the CATIE study and
18 after Dan died?
19 A I'm not quite following. If you could restate the
20 question for me.
21 Q Okay.
22 A So there is --
23 Q The CATIE study and the CAFE study involve atypicals,
24 right?
25 A Both do.
180

1 Q Right, and the FDA issued a warning about diabetes and
2 hyperglycemia for these drugs, right?
3 A Correct.
4 Q There was a reconsent that is a consent amendment.
5 A Uh-huh.
6 Q That was done for the CATIE study.
7 A Okay.
8 Q And there was one done for the CAFE study.
9 A All right.
10 Q And the CATIE study was done much earlier.
11 A This is, here's where I'm losing you. If I can clarify.
12 Q Yes.
13 A When you say the CATIE study was done a month earlier,
14 meaning by Dr. Lieberman?
15 Q Well, we're on 3. Do you see this?
16 A Yeah.
17 Q Do you see the date in the bottom left? What does that
18 say, April?
19 A It says April 5, 2004.
20 Q Are you aware of when the CAFE study finally issued their
21 similar reconsent amendment?
22 A Well, the point of clarification I was trying to ask
23 you --
24 Q That's a specific question.
25 A You had another question --
181

1 Q Yeah.
2 A -- on the floor for me.
3 Q We'll get back to it. As coinvestigator of the CAFE
4 study, are you aware of the date the CAFE study issued
5 its reconsent amendment?
6 A Let me answer that. So my earlier question had to do
7 with when you said the consent amendments of being
8 issued, etc. So your question to me is, so I understand,
9 that the overall principal investigators of the CAFE
10 study took a month longer to get the consent amendment
11 sent out to the sites? Is that what your question is?
12 Q What my question is, is I'm showing you the date of the
13 consent amendment for the CAFE study.
14 A Okay.
15 MR. ALSOP: No, it's the CATIE study, sir.
16 BY DR. BARDEN:
17 Q The CATIE study, April 5, 2004. Do you see that?
18 A Yes, I do.
19 Q My question to you is a very specific one, and it
20 requires a yes or no, first of all. Were you aware that
21 the CAFE study also issued a consent amendment warning
22 subjects about this increased risk of diabetes and
23 hypoglycemia? Hyperglycemia.
24 A Not specifically, I wasn't aware that that had been
25 issued.
182

1 Q Okay. Did anyone ever come to you and say, you know,
2 we're way behind the CATIE study in issuing this warning,
3 we better get it out to the CAFE subjects? Did anyone
4 approach you and say anything like that?
5 A No.
6 Q If you had found out that the CAFE study warning to
7 subjects was significantly later, by as much as a month
8 after the CATIE subjects were warned, would that trouble
9 you, as a physician interested in the well-being of the
10 CAFE subjects?
11 MR. ALSOP: Object as irrelevant,
12 misstatement of the facts, and argumentative. Go ahead.
13 THE WITNESS: My answer is, I would want to
14 better understand what had happened. And any time there
15 is a change in the consent form, it is concerning, and I
16 would want to learn more about what happened.
17 BY DR. BARDEN:
18 Q Uh-huh. Did anyone ever come to you and say, you know,
19 Dan Markingson never had the opportunity to reconsent for
20 the study based on these new risks and dangers, because
21 they didn't issue the warning until a month after CATIE
22 and after Dan was dead?
23 MR. GROSS: Objection, misstates the
24 evidence.
25
183

1 BY DR. BARDEN:
2 Q Did anyone ever come and state that to you?
3 A No, they did not.
4 MR. GROSS: Objection, misstates evidence.
5 MR. ALSOP: It's irrelevant. Go ahead.
6 THE WITNESS: I've already answered it.
7 MR. ALSOP: Yeah, that's fine.
8 BY DR. BARDEN:
9 Q Let's look at the next page, page 4. It's an e-mail. On
10 the top it says March 15, 2004. Do you see that? Then
11 down below it says, "Dear CAFE Investigators and Study
12 Coordinators. Recently the FDA issued a new warning
13 about the risks of hyperglycemia and diabetes in patients
14 taking atypical antipsychotic agents, including the CAFE
15 study medications." Do you see where it says that?
16 A Yes, I do.
17 Q So they were on notice as of this March 15, 2004,
18 correct?
19 MR. ALSOP: Object on the basis of
20 foundation, but go ahead.
21 THE WITNESS: Okay. Again, the question
22 is -- I'm sorry. I get distracted with the multiple
23 conversation.
24 BY DR. BARDEN:
25 Q The CAFE investigators, that would include you, correct,
184

1 you are a coinvestigator?
2 A I am a coinvestigator.
3 Q So you received notice of this also, correct?
4 A I probably did not receive this. I'm awfully sure I
5 didn't.
6 Q But Dr. Olson, who certainly as the investigator, would
7 receive one?
8 A As principal investigator, he would have received this.
9 Q All right, and it says, "Some sites were required to add
10 this information earlier by their IRBs, but if your
11 consent form does not contain information about diabetes,
12 it is recommended that you add it." Do you see that?
13 A Yes, I do.
14 Q Look at page 6, bottom right, UM SPA 0437, University of
15 Minnesota, attention payments, Quintiles, Inc. Was that
16 the company that was doing the study, Quintiles?
17 A I believe Quintiles is known as the CRO, a clinical
18 research organization.
19 Q It says -- and where does the money for Quintiles come
20 from, to the best of your knowledge?
21 MS. AHMANN: Object, lack of foundation.
22 BY DR. BARDEN:
23 Q It came from AstraZeneca, didn't it?
24 A To the best of my knowledge, when Quintiles oversees a
25 study, they are paid by the study sponsor. So like for
185

1 CATIE, the NIMH would.
2 Q Right, and it says -- and for this one, AstraZeneca paid
3 them, right?
4 MS. AHMANN: Object, lack of foundation.
5 THE WITNESS: Yeah, CAFE study, Quintiles.
6 BY DR. BARDEN:
7 Q Yeah, AstraZeneca.
8 A Quintiles were in the study, AstraZeneca provided the
9 money.
10 Q Right. It says make check payable to University of
11 Minnesota. Do you see that, upper right there, check
12 payable to University of Minnesota?
13 A Yes.
14 Q Reference or description, "Per Agreement Due Upon
15 Initiation of Study." That means getting someone in the
16 study as the subject, right?
17 A No.
18 Q Oh, I see. Oh, I forgot. The contract said if they
19 didn't get a subject in, then they had to refund this
20 money, correct?
21 A I don't know that.
22 MS. AHMANN: Object, lack of foundation.
23 BY DR. BARDEN:
24 Q You don't know that? You haven't seen a contract for the
25 CAFE study?
186

1 A No.
2 Q Well, it says that amount $16,362, and then it says,
3 "Independent Review Board Fees." What's that for, do you
4 know?
5 A My understanding is that's the IRB fee.
6 Q Okay, so the IRB was paid by AstraZeneca.
7 MS. AHMANN: Objection, lack of foundation.
8 THE WITNESS: By Quintiles.
9 MR. GROSS: Same objection.
10 BY DR. BARDEN:
11 Q Have you ever seen any statements under oath by an IRB
12 official saying they're not paid by drug companies or
13 outside companies?
14 A No.
15 Q Interesting. Okay. Now let's go to page 8, bottom right
16 corner, 8, UM CAFE 3191, the bottom of the page,
17 "Recruitment Efforts?"
18 A Where are --
19 Q This is an e-mail to Jeannie Kenney. Have you seen that
20 name before?
21 A Yes, I have.
22 Q Who is Jeannie Kenney? What does she do?
23 A Jeannie Kenney was a project coordinator and social
24 worker in the Department of Psychiatry.
25 Q Was she paid for her work on the CAFE study?
187

1 MR. GROSS: Objection, lack of foundation.
2 THE WITNESS: I believe so.
3 BY DR. BARDEN:
4 Q Do you have any idea how much she was paid?
5 A I'm sorry, I take that back. I apologize. Jeannie
6 Kenney was a member of the Department of Psychiatry, and
7 she received a salary for her work. A portion of her
8 salary came from the University of Minnesota Physicians
9 for her work in clinic. She received a University check
10 for her work on a variety of studies.
11 Q So she did receive some funding that came from the CAFE
12 study, correct? In fact, she's listed right on the study
13 documents as receiving funds.
14 MS. AHMANN: Same objection.
15 THE WITNESS: I thought I answered the
16 question.
17 MR. ALSOP: You have.
18 BY DR. BARDEN:
19 Q Looking at page 3191, it says, "Recruitment Efforts: In
20 an effort to assist you in your recruitment efforts, a
21 monetary allowance is being made available to you to
22 provide food and beverages at functions that serve as a
23 forum to recruit subject for the CAFE study. Your site
24 would be reimbursed up to $100 over each 3 month period.
25 Quintiles will pay on behalf of AstraZeneca for
188

1 reasonable costs upon review and receipt of an invoice."
2 Was that your understanding of the policy?
3 MR. ALSOP: Objection on the basis of
4 foun --
5 BY DR. BARDEN:
6 Q Was this in recruitment?
7 MR. ALSOP: Objection on the basis of
8 foundation.
9 MR. GROSS: Same objection.
10 MS. AHMANN: Same objection.
11 MR. ALSOP: It's also vague as to -- go
12 ahead.
13 BY DR. BARDEN:
14 Q Is that your understanding of the policy?
15 A What policy?
16 MR. ALSOP: What policy?
17 BY DR. BARDEN:
18 Q I'm not sure of the --
19 A I can certainly see that Quintiles wrote the letter, and
20 it's not, in my experience, unusual for a company like
21 Quintiles to provide support for investigators to meet
22 with community groups to explain there is a study going
23 on.
24 Q Okay, so they would pay money on behalf of AstraZeneca
25 for reasonable costs to assist them in their recruitment
189

1 efforts, and it's your understanding that's not uncommon.
2 A That's correct.
3 Q Okay. If you look at page 13, bottom right. This is
4 UM CAFE 3006. From Danielle Simons at Quintiles. Did
5 you ever get an e-mail from Danielle Simons?
6 A No.
7 Q And under the CC list, you see where it says Stephen
8 Olson?
9 A Okay. That's like at the middle page, Danielle Simons,
10 Elizabeth Lemke.
11 Q Stephen Olson was the PI for the CAFE study?
12 A Same group. Danielle, Elizabeth Lemke, Jeannie Kenney,
13 and Steve Olson. I mean, it's to Ande somebody. I don't
14 know who that is.
15 Q Okay. So at the bottom, it talks about "Consent Versions
16 6-26-02." "Enclosed are a copy of the letter we're
17 sending to the IRB with the consents, a copy of each of
18 the two consents including the stipulations you'd
19 suggested, and a copy of the letter we sent to the IRB
20 along with a copy of our site approval letter. Next on
21 the docket then is recruit, recruit, recruit!"
22 Exclamation point. "This is so exciting--thank you so
23 much for everything you've done so far to get us going!"
24 So they were very interested in focusing on
25 recruiting, correct?
190

1 MR. ALSOP: Object as vague, also lacks
2 foundations, but go ahead.
3 MR. GROSS: Calls for speculation.
4 BY DR. BARDEN:
5 Q Is this common, that the companies are trying to pump
6 people up to go out and recruit subjects for drug
7 studies?
8 MR. GROSS: Objection, misstates evidence.
9 MR. ALSOP: Assumes facts not in evidence,
10 but go ahead.
11 MS. AHMANN: Join.
12 THE WITNESS: Let me just ask a question. I
13 can see here -- I'm not sure who this memo is to. I can
14 see who it's copied to, but I don't know who it's to.
15 BY DR. BARDEN:
16 Q Well, these are the UM CAFE study documents, so we have
17 to --
18 A I'm sorry --
19 Q This says, this is, "Hi Danielle," which would be
20 Danielle Simons at Quintiles, and it's from Elise, who
21 Elise is at the -- she's at the University of Minnesota,
22 I'm told. But my question to you really didn't go to
23 that. My question went to --
24 A And --
25 Q -- is this common, this kind of focus on recruiting, is
191

1 that something you see when you're in that business?
2 MR. ALSOP: Assumes facts not in evidence,
3 lacking in foundation, argumentative, but go ahead.
4 MS. AHMANN: Join.
5 THE WITNESS: Just to be clear, we're no
6 longer talking about the e-mail then.
7 BY DR. BARDEN:
8 Q We're talking about the e-mail, as an example of a
9 typical e-mail exhorting people to go out and recruit
10 subjects. And my question to you is, is that common in
11 this particular industry --
12 MR. ALSOP: Now --
13 BY DR. BARDEN:
14 Q -- that kind of exhortation to recruit, recruit, recruit?
15 You either know or you don't, based on your special
16 experience of doing many of these studies and dealing
17 with these drug companies.
18 MR. ALSOP: Object again to the misstatement
19 of this document, and it's argumentative, it's vague, and
20 it's multiple, but go ahead.
21 MS. AHMANN: Join.
22 THE WITNESS: My response to this is that
23 all clinical trials are under pressure to recruit to
24 finish their studies. This includes the
25 National Institute of Health, where investigators need to
192

1 recruit in order to be able to complete the projects that
2 they've been approved and been provided funding for, and
3 it includes industry-sponsored trials, especially in the
4 area of registration of a medication and for studies such
5 as this to try to find out what are the best treatments
6 for the early stages of schizophrenia.
7 BY DR. BARDEN:
8 Q Right, a lot of pressure to recruit.
9 A Yup.
10 Q Because if you don't finish the study, you don't get to
11 publish, right, Doctor?
12 MR. ALSOP: That's a misstatement of his
13 prior testimony. Wait, wait. And I --
14 DR. BARDEN: You don't get to say the whole
15 sentence. You can say misstates.
16 MR. ALSOP: I had other objections, sir. I
17 have interrupted you not once.
18 DR. BARDEN: Make a legal objection.
19 MR. ALSOP: I did.
20 DR. BARDEN: Go ahead.
21 MR. ALSOP: It's a misstatement of the
22 evidence, it's argumentative, and it's vague. Go ahead.
23 MS. AHMANN: Join.
24 BY DR. BARDEN:
25 Q And you testified earlier that maybe publishing isn't
193

1 that important to some people's careers, right?
2 A Yes, I did.
3 Q Okay. We'll show you your resume again, marked as
4 Exhibit A. How many pages of your resume contain nothing
5 but your publication list, Dr. Schulz?
6 A Well, actually --
7 Q No, no. It's a numerical answer.
8 MR. ALSOP: Go for it.
9 THE WITNESS: I'm sorry. I didn't
10 understand the question that way.
11 BY DR. BARDEN:
12 Q How many pages of your resume contain your publications?
13 A So my publications start on the mid point of page 10, and
14 they conclude on page 24, so that would be 14 out of 26
15 pages, a little more than half.
16 Q Thank you. You can't publish a study unless you've
17 completed it. Isn't that correct, Doctor? You have to
18 write it up when it's done and you have results to
19 publish.
20 MR. ALSOP: It's now a multiple question,
21 but go ahead, you can answer.
22 THE WITNESS: It's just a general question?
23 BY DR. BARDEN:
24 Q Yeah. It's easier to publish a study that's been
25 completed.
194

1 A Yes.
2 MR. ALSOP: Is that a statement or question?
3 Go ahead.
4 DR. BARDEN: He answered it.
5 BY DR. BARDEN:
6 Q Now, let's look at page 14, at the bottom right, of
7 what's been marked as Exhibit --
8 A Just look here.
9 Q You see here's an e-mail from Amy VandenEynden at
10 Quintiles to Jeannie Kenney. Do you see that?
11 A Yes, I do.
12 Q And it says, "It sounds like you have a good amount of
13 leads/potentials. Hopefully your hard work will start to
14 pay off soon!" Exclamation point. "The specialty
15 inpatient unit sounds like it will help out a lot with
16 recruitment!!" Exclamation point, exclamation point.
17 Did you set up that specialty inpatient unit to make it
18 particularly easy to recruit psychotic patients?
19 MR. ALSOP: It's a multiple question, it's
20 vague, but go ahead.
21 THE WITNESS: I talked with the
22 administration at University of Minnesota Medical Center
23 to indicate to them that I thought having a unit that
24 specialized in the care of people with serious
25 psychiatric illness would improve the quality of care to
195

1 schizophrenic patients in the Twin Cities; and in
2 addition to that, I discussed, when I made my original
3 recommendations, that it would foster the academic goals
4 of the medical school and our department.
5 BY DR. BARDEN:
6 Q You see down here it says, "Take care and try not to get
7 too frustrated!" Trying to recruit can be frustrating
8 sometimes. Isn't that right, Doctor?
9 A Yes.
10 Q Okay. Let's look at the next e-mail. Bottom of 14.
11 Again, this is --
12 MR. ALSOP: What page number?
13 DR. BARDEN: Fourteen, at the bottom there.
14 It's UM CAFE 2959.
15 MR. ALSOP: Okay.
16 BY DR. BARDEN:
17 Q It says Jeannie Kenney to Amy VanderEynden at Quintiles.
18 It says in the e-mail, "The last young woman who was
19 referred from inpatient would have benefitted so much
20 from this study. I put in a lot of time, meeting with
21 the case manager and attended the discharge planning
22 meeting. I thought the parents were interested. I do
23 have her scheduled with Dr. Olson for outpatient med
24 management so perhaps we can gain their trust and offer
25 it as an option again."
196

1 Is this the kind of e-mail that goes back
2 and forth between the drug company financing running the
3 study and the people recruiting, to the best of your
4 knowledge?
5 MS. AHMANN: Objection, as to misstates who
6 this is to and from, and also lack of foundation.
7 DR. BARDEN: Back and forth? This is from
8 Jeannie Kenney to Amy VandenEynden at Quintiles, right?
9 MS. AHMANN: Yeah, but you said it was from
10 the drug company.
11 DR. BARDEN: I don't think I said drug
12 company.
13 THE WITNESS: Yes, you did.
14 MR. ALSOP: I think you did.
15 DR. BARDEN: Okay. Excellent.
16 BY DR. BARDEN:
17 Q From the company paid by the drug company to conduct the
18 study?
19 MS. AHMANN: Lack of foundation.
20 BY DR. BARDEN:
21 Q So is this the kind of letter you see?
22 MR. ALSOP: Objection as lacking in
23 foundation.
24 BY DR. BARDEN:
25 Q Do they share information about patients and who they're
197

1 trying to recruit and whether they've spoken to the
2 parents?
3 A I haven't seen e-mails like this in my experience, no.
4 Q Trying to gain their trust and -- okay. It says, "the
5 hospital is opening a psychosis specialty inpatient unit
6 first of April. Dr. Olson and I are very much involved
7 in the planning so will have closer contact with first
8 episode people who come in. We are really hoping to
9 promote state-of-the-art care and potential for research
10 is part of the programming. In fact, it will be
11 discussed in the interviewing of staff so it will be nice
12 to have a treatment team fully on board with what we are
13 doing in the department." Have you ever seen that e-mail
14 before today?
15 A No.
16 Q Okay. Next, next, this is the e-mail back. "Hi--I can
17 understand that you are frustrated!!" Exclamation point,
18 exclamation point. "Do what you can with subject 002.
19 Please call if the subject gets out of window, because
20 there is always the possibility of granting exceptions.
21 If I am not available, contact Jennifer Frantz. As for
22 recruitment, have you had any luck with any of the area
23 facilities? I thought you mentioned you'd go to area
24 sites and give them information. Is there anything we
25 can [do to] provide to help you with this? Amy." Have
198

1 you ever seen this before today?
2 A No, I did not.
3 Q Okay. Next e-mail, Jeannie Kenney to Amy VanderEynden,
4 Quintiles. "Hi Amy. Having trouble with Subject 002.
5 His sister just died, his father has terminal cancer and
6 now the grandmother is sick. He missed a visit and now
7 just missed the next one. I hope I can get him in for
8 the allowable window for the visit he missed Friday. I
9 understand the situation is really difficult but am
10 afraid we might be losing him when his family thinks he
11 probably needs this treatment now more than ever. Have
12 had another person show interest from inpatient and then
13 the parent put the pressure on and said," quote, "'NO,'"
14 unquote. Paragraph, parentheses, "(3rd time this has
15 happened)," close parentheses. "Have tried to ask about
16 concerns, etc. but usually just get a NO. So, some
17 frustration here because we really need to get more
18 enrollees. We've had none for January and that concerns
19 me a lot."
20 Did you ever see that letter before today?
21 A No.
22 Q The date of that is January 27, 2003. "Parent put the
23 pressure on and said, 'NO". (3rd time this has
24 happened)." Does that help us understand why nobody
25 listened to Mary Weiss?
199

1 MR. ALSOP: You don't have to answer that
2 question. There is no question. Just wait. Ask --
3 BY DR. BARDEN:
4 Q Based on your knowledge of the CAFE study and what's in
5 this letter, does that help us understand why Dr. Olson
6 ignored Mary Weiss's complaints about the study and
7 complaints about her son's deteriorating mental health
8 and warnings that he was going to commit suicide?
9 MR. ALSOP: It's argumentative and a
10 misstatement of the facts. Go ahead, Doctor. And
11 lacking in foundation. If you have any idea, go ahead.
12 MS. AHMANN: Same, join in the objection.
13 THE WITNESS: I don't see the link between
14 this e-mail and what I know of Dan's case.
15 BY DR. BARDEN:
16 Q Okay. Please look at page 18 on the bottom right.
17 Again, this is from Jennifer I. Frantz at Quintiles,
18 November 2002, to Jeannie Kenney. "Hi Jeannie, I made a
19 blunder when I reviewed your consent and am really really
20 sorry." Goes on to say, "My hope is that your IRB
21 already caught it or that it has not been reviewed yet."
22 A I'm sorry, where are we now?
23 Q We're just following right along here.
24 A I guess we kind of skipped this part?
25 Q Yeah. I'm going to ask you questions about particular
200

1 sentences. "I don't think this should hold up any
2 patients at your site as long as you explain the
3 procedures correctly and indicate it on the form that
4 they sign while notifying the IRB of the mistake. I am
5 so sorry for any inconvenience this causes you. Thanks,
6 Jen."
7 Did you as a coinvestigator ever see this
8 e-mail before today?
9 A No.
10 Q Okay. To Amy VandenEynden from Jeannie Kenney, and this
11 is September 29, 2002, UM CAFE 2989. "Hello, I know that
12 our site is on hold/probation for CAFE recruitment but I
13 have some things I want to make sure I have updated." As
14 a coinvestigator, were you ever aware that your site was
15 on hold/probation for CAFE recruitment?
16 A Yes.
17 Q And what was that for, to the best of your knowledge?
18 A My understanding was that Quintiles felt, or indicated
19 that it is expensive to run multiple sites, and that if a
20 site is unable to enter subjects in the study, then what
21 they would prefer to do is work with sites that can.
22 Q And how long were you on hold/probation?
23 A I don't know.
24 DR. BARDEN: Can we go off the record for
25 just a minute here?
201

1 (Brief recess taken.)
2 DR. BARDEN: We're back on the record?
3 Great.
4 BY DR. BARDEN:
5 Q Thank you. Show you what we're going to mark as
6 Exhibit L.
7 A Done with this?
8 Q Yes, done with that.
9 (Schulz Deposition Exhibit L marked for
10 identification.)
11 MR. ALSOP: One page?
12 DR. BARDEN: Uh-huh, one page.
13 MS. PEARSON: I think there is a paper clip
14 somewhere.
15 BY DR. BARDEN:
16 Q This is from the financial records of CAFE study. It's
17 UM SPA 0068, 'and Dr. Schulz, have you ever seen this
18 document before?
19 A I don't believe so.
20 Q Wait a minute. Yeah, we're going to look at that. At
21 the top, you see where it says principal investigator,
22 Dr. Stephen Olson?
23 A Yes, uh-huh.
24 Q And it talks about the CAFE study, correct?
25 A Uh-huh.
202

1 Q And the total grant amount, what is that dollar amount?
2 A $327,057.
3 Q And was that your understanding of the CAFE study amount?
4 A Well, I'm not surprised by that amount.
5 Q And then under Stephen Olson, do you see that, M.D.?
6 A Yes.
7 Q There is some dollar numbers there. Can you read those
8 off for us?
9 A Sure. So Dr. Stephen Olson is listed as eight percent.
10 Right here at this highlight (indicating)?
11 Q Yeah, uh-huh.
12 A And then the top number is $7,220.76, and then it has
13 some other periods with some changing percentages, so
14 it's March 3rd through, March 3rd through 2004. I'm a
15 little confused by that. I'm sorry. Anyway, $6,987.35.
16 Then 3/4, that might be March of '04, to June of '04, is
17 my speculation, $2,000. This is probably July '04 to
18 September '04, $1,770; and September '04 to February '05,
19 $2,509.76.
20 Q So are those the amounts that AstraZeneca was reimbursing
21 the University for Dr. Olson's time?
22 MS. AHMANN: Objection, lack of foundation.
23 BY DR. BARDEN:
24 Q Or how did that work? What's your particular
25 understanding of that?
203

1 A Okay. So when a person receives word that they're going
2 to get a grant, then they notify the sponsored projects
3 section of the University. The University makes a
4 contract, in this case it would have been with Quintiles,
5 and they conclude that this is going to be the total
6 amount for the grant if all the subjects described enter
7 the study.
8 Q Uh-huh.
9 A So if -- so that's what this number is.
10 Q Okay, so if fewer -- if they don't get the number of
11 subjects, the money goes down, correct?
12 A Correct.
13 Q Now, I don't see Quintiles on there anywhere. What I see
14 is this name of AstraZeneca Pharmaceuticals.
15 A Yeah, I see that too.
16 Q Do you see that?
17 A Uh-huh.
18 Q We don't see Quintiles anywhere on this form, do we?
19 A Yeah.
20 Q So then if they don't recruit and they don't get the
21 number of subjects, then money reimbursed goes down.
22 A That's correct, because less work was done.
23 Q Right, and then you also see ten percent for you,
24 Dr. Charles Schulz, correct?
25 A Yeah, and then --
204

1 Q It says for effort only?
2 A Effort only.
3 Q But you're listed as ten percent.
4 A Uh-huh.
5 Q And in some other documents, it says ten percent for
6 training and supervision. Isn't that right?
7 A Uh-huh.
8 Q So did you tell the IRB and the companies that you were
9 going to do this ten percent, and then you didn't do it;
10 or how did that work?
11 A I told Dr. Olson I was going to work on the study and
12 assist him, and I was, I believe, assigned that I would
13 be available up to ten percent time, but that I did not
14 want to receive any money for whatever he might call upon
15 me to do.
16 Q But apparently he never called on you.
17 A Correct.
18 Q Then we have Jean Kenney, and then we have a listing of
19 dollars for her. We won't go through all those, but it
20 starts at 11,500 some dollars and goes on down from
21 there. So this basically kind of outlines some of the
22 funding that was involved in the CAFE study, correct?
23 A Yes.
24 Q Okay.
25 DR. BARDEN: Next we'll mark this as
205

1 Exhibit M.
2 (Schulz Deposition Exhibit M marked for
3 identification.)
4 BY DR. BARDEN:
5 Q It's a letter on AstraZeneca letterhead, correct?
6 A Yes.
7 Q It looks like it's to Stephen Olson, M.D.?
8 A Yes.
9 Q The University of Minnesota Department of Psychiatry.
10 Signed by Savinder --
11 A Can you go back just for a second?
12 Q Uh-huh.
13 A It's interesting, as you're pointing this out to me, that
14 it's addressed to Dr. Olson, who is the principal
15 investigator, but the letter was sent to the Office of
16 Sponsored Projects Administration.
17 Q Okay.
18 A So it would not have gone immediately to him. It would
19 have gone over to --
20 Q Sure.
21 A -- what we call SPA.
22 Q But it's signed by you, you recognize Dr. Olson's
23 signature there, correct?
24 A Correct.
25 Q Yeah.
206

1 A I just thought I'd mention that it probably went through
2 SPA, they looked at this, then brought it over, forwarded
3 it to Dr. Olson.
4 Q That's fine. And then we have a Sue Marshall signing for
5 the Regents of the University of Minnesota?
6 A Yes.
7 Q And then we have Savinder Saini, Esquire, signing for
8 AstraZeneca, it looks like, right?
9 A Yes, that's what it looks like to me.
10 Q And it says, this highlighted section in the middle there
11 just says, "PER SUBJECT PAYMENT, $15,648." Did I read
12 that right?
13 A Yes.
14 Q Okay. Then on the next page, second part of the letter,
15 it says, "AstraZeneca shall pay to Institution the Per
16 Subject Payments according to the milestone payment set
17 forth below: Completion of Visit 3: $4,452, completion
18 of Visit 6: $1,482, completion of Visit 9: $2,352,
19 completion of Visit 12," and so on, correct?
20 A Yes.
21 Q Then below that it says, "Compensation for subjects who
22 do not complete the Study will be calculated on a
23 prorated basis according to the following schedule," and
24 there is a prorated basis for payments, correct?
25 A That's what it looks like the document says, yes.
207

1 Q Okay, great. That's yours.
2 All right. We'll show you what's marked as
3 Exhibit N.
4 MR. ALSOP: I guess we're going to mark the
5 original.
6 (Schulz Deposition Exhibit N marked for
7 identification.)
8 BY DR. BARDEN:
9 Q Okay. Doctor, I want to call your attention to -- all
10 right. See at the top there where it says check date of
11 17 October 2005, right?
12 A Yes.
13 Q And it says, "Sponsor: AstraZeneca Pharmaceuticals, LP,"
14 correct?
15 A Yes.
16 Q Okay, and it says, "Site: Stephen Olson," has a number
17 for him, correct?
18 A Yes.
19 Q Okay, and at the bottom it says, "Regents of the
20 University of Minnesota," and it's Quintiles,
21 Wachovia Bank check for $30,622, correct?
22 A Yes.
23 Q Okay. I'd like to call your attention to the patient
24 visit about two-thirds of the way down, patient ID
25 No. 13. Were you aware that's Dan Markingson's number?
208

1 A No.
2 Q Okay, and then you see a visit ID was visit 19. Do you
3 see that?
4 A Yes, I do.
5 Q Do you see the date was May 8, 2004?
6 A I do see that.
7 Q And do you see the payment was made for $1,446 on that
8 day for that visit?
9 A For that line, I saw, yeah.
10 Q For that visit?
11 A Uh-huh.
12 Q Yeah. Does that date ring a bell to you? Are you
13 familiar with any of the dates in this study?
14 A No.
15 Q Yeah. Dan Markingson was deceased on that day.
16 A Okay. Sorry.
17 Q So he really didn't have a visit 19.
18 A Okay.
19 Q But apparently Dr. Olson fell for it.
20 MR. GROSS: Objection, lack of foundation.
21 MR. ALSOP: It's argumentative, misstates --
22 MS. AHMANN: Can I just, I'm going to lodge
23 my objection, and she keeps telling me she doesn't hear
24 me, but the reason is, can you just pause when people
25 start objecting so she can get the objections down?
209

1 Thanks.
2 BY DR. BARDEN:
3 Q All right. Do you have any explanation for this document
4 other than what we've discussed so far?
5 A No.
6 Q If Dr. Olson had billed for a date on which his patient
7 was deceased, would you have a trouble with that?
8 A Certainly.
9 DR. BARDEN: How are we coming on the
10 Xeroxing?
11 MR. ALSOP: I can go check, if you want me
12 to check.
13 DR. BARDEN: Yeah. Why don't we just
14 take --
15 MS. AHMANN: Use those ones you copied
16 before, or are those not --
17 DR. BARDEN: Oh, yes. Hopefully, well,
18 hopefully we'll get to that.
19 MS. AHMANN: Okay.
20 DR. BARDEN: You mean these, the last
21 packet?
22 MS. AHMANN: Yeah, that's fine.
23 MR. ALSOP: There is three or four things
24 here to be copied.
25 DR. BARDEN: Let's go ahead and do that.
210

1 This is Exhibit O.
2 MR. ALSOP: Which one is it?
3 DR. BARDEN: It's a new one.
4 MR. ALSOP: Do we have a copy of it here?
5 DR. BARDEN: I think you do, yeah. That's
6 it. There you go.
7 MR. GROSS: Is it the Theo I records?
8 (Schulz Deposition Exhibit O marked for
9 identification.)
10 BY DR. BARDEN:
11 Q Okay, Dr. Olson -- Dr. Schulz. Trying to understand how
12 this study worked. If you look on the back of these two
13 sheets, see where it says, "If medication is missed,
14 indicate one of the following orders." Do you see that?
15 A Okay. Where? Okay. Where, here (indicating)?
16 Q Right there (indicating).
17 A Okay.
18 Q The one dated 12-19-03, do you see that?
19 A I see there is a note there, 12-9 -- 12-19.
20 Q It says, "If medication is missed ... omit the dose
21 entirely." Do you see that?
22 A Uh-huh.
23 Q Okay, and then the other sheet is 12-11-03, and that
24 says, "If medication is missed ... add the missed dosage
25 to the next med time." Do you see that?
211

1 A Yes, I do.
2 Q Help me understand why, a week apart, that that would be
3 like that.
4 MR. ALSOP: Object on the basis of
5 foundation, but go ahead.
6 BY DR. BARDEN:
7 Q Why would the suggestion as to what to do if medication
8 is missed be different week-to-week like that?
9 MR. ALSOP: Foundation. If you know, go
10 ahead.
11 THE WITNESS: So thanks for giving me a few
12 minutes to take a look at this form, and I can really
13 only speculate that the difference in the two orders are
14 related to, in the first document, it looks as if the
15 patient is making a transition into the study; and so in
16 Dr. Olson's judgment, he felt that adding the missed dose
17 may be the best way to proceed.
18 On the second sheet, which is a week later,
19 it looks to me as if on the back he's discontinued the
20 Risperdal, which was his original clinical medicine, and
21 he's now on the CAFE-assigned medications. So for
22 whatever reasons that I won't speculate about, Dr. Olson
23 decided that he would change the order.
24 BY DR. BARDEN:
25 Q Okay. Let's go back to -- do we have this one?
212

1 DR. BARDEN: Does everyone have this one?
2 On the top it says, "Agenda for CAFE web-cast meeting."
3 MR. ALSOP: I think it's passed out, yup.
4 DR. BARDEN: We're going to -- wait a
5 minute. I need a Xerox copy of it so I can make an
6 exhibit of it; or actually, do you have it?
7 MR. ALSOP: There should be five copies.
8 DR. BARDEN: Yeah, because I need to keep
9 mine, the marked-up one.
10 MR. ALSOP: Do you want this marked?
11 DR. BARDEN: Yes, sir, thank you.
12 (Schulz Deposition Exhibit P marked for
13 identification.)
14 BY DR. BARDEN:
15 Q If you look at the first page of what's been marked as
16 Exhibit No. P, you see at the bottom UM CAFE 0695. Do
17 you see that document?
18 A Yes, I do.
19 Q Okay. It says, "Agenda for CAFE web-cast meeting on
20 Wednesday, October 29th."
21 A What year is that?
22 Q I don't think it says on here. So it says, the second
23 heading down, "Enrollment: Joe McEvoy--review current
24 enrollment status and discuss recruitment goals for
25 ensuring study completion. 15 MINUTES." The next one is
213

1 "Success spotlight: Irving Belz, M.D., [and] Stephen
2 Olson, M.D.--sites that have been successful with turning
3 an under-performing site into a well-performing site
4 present their strategies."
5 Is it your understanding, Dr. Schulz, that
6 the strategies they're talking about are recruitment
7 strategies for getting subjects into the study, correct?
8 MR. ALSOP: I object on the basis of
9 foundation, but go ahead.
10 THE WITNESS: I don't know what they were
11 supposed to talk about.
12 BY DR. BARDEN:
13 Q Have you never been present for a recruitment study
14 meeting, in a meeting to improve or recruitment
15 strategies?
16 A For CAFE?
17 Q Yeah.
18 A No.
19 Q For other studies?
20 A Sure.
21 Q Okay, so that's fairly common, that you'd have meetings
22 to improve the recruitment strategies, correct?
23 A I'm trying to think specifically, but in general, I'll
24 say sure.
25 Q In addition to the 300,000 plus dollars we've talked
214

1 about with the CAFE study, and in addition to the
2 publications that might come from that, were there in
3 fact a number of other potentially very lucrative
4 research studies that could emanate or flow from
5 successful recruitment in the CAFE study?
6 MR. ALSOP: Object as vague and ambiguous,
7 speculative, lacking in foundation. Go ahead.
8 MS. AHMANN: Join.
9 THE WITNESS: Well, there certainly were a
10 lot of adjectives there, so let me just try my best to
11 answer the question. Clearly, if a faculty member in a
12 clinical department does well, meaning says I will
13 recruit ten people and recruits ten people, the
14 likelihood that they would be invited to be involved in
15 further studies goes up compared to somebody who makes a
16 commitment and doesn't fulfill it.
17 BY DR. BARDEN:
18 Q Wasn't it in fact there was potentially millions of
19 dollars involved to the University of Minnesota in making
20 darn sure that Dr. Olson got enough subjects into the
21 CAFE study? Isn't that right?
22 MR. ALSOP: Object as argumentative.
23 BY DR. BARDEN:
24 Q Looking down the road at all the studies that were
25 related to it, for example?
215

1 MR. ALSOP: Object as argumentative. Now we
2 have multiple question, vague and ambiguous, lacking in
3 foundation. Go ahead.
4 MS. AHMANN: Join.
5 THE WITNESS: I'm not aware of any studies
6 related to the CAFE study.
7 BY DR. BARDEN:
8 Q Okay. Would you look at the next page, please. It says
9 UM CAFE document 0708. At the top it says, "Below is a
10 list of studies currently conducted at the University of
11 Minnesota for which subjects participating in CAFE/CATIE
12 are considered: No. 1, Diagnostic Assessment Core ...
13 for studies in schizophrenia and related disorders.
14 Principal investigator: Stephen Olson." Then next page,
15 it says, page 2, "White Matter Abnormalities in
16 Schizophrenia." No. 3, "Genomics and White Matter
17 Abnormalities in Schizophrenia." No. 4, "High Field MRS
18 of Brain Development and Schizophrenia." Next page,
19 No. 5, "Spatio-temporal studies of sensory and cognitive
20 cortical processing in schizophrenia." No. 6, "Brain
21 Surface Morphology in childhood and Adolescent Onset
22 Schizophrenia." Next page, No. 7, "Study --"
23 A I'm sorry, this says -- page 4 is the one we were just
24 on?
25 Q I'm looking at the numbers that are listed here. I'm
216

1 sorry. Next page, No. 7.
2 A In the middle of the page.
3 Q "A study of Prefrontal-Mediated Tasks in Children and
4 Adolescents with Schizophrenia and their siblings."
5 No. 8, "The Disregulation of Optimized Cognition in
6 Schizophrenia."
7 Does that help jog your memory that there
8 were other studies that were related to success in
9 recruiting people for the CAFE study?
10 MR. ALSOP: That's a misstatement of this
11 document and argumentative and lacking in foundation, but
12 go ahead.
13 BY DR. BARDEN:
14 Q That's a yes or no.
15 MS. AHMANN: Join.
16 MR. ALSOP: You can answer it any way you
17 want to answer it, Doctor.
18 THE WITNESS: Can you restate the question
19 after all the conversation?
20 BY DR. BARDEN:
21 Q Were there studies at the University related to CAFE?
22 A These studies were not related to CAFE.
23 Q Really. Even though it says that they're currently
24 conducted for subjects participating would be considered.
25 So if you had subjects in CAFE, they would be considered
217

1 as subjects for these other studies, thus helping them to
2 be completed, thus helping them to be fully funded, thus
3 helping them to be published, leading to more money and
4 more studies, correct?
5 MR. ALSOP: That's a multiple question,
6 argumentative, a misstatement of his prior testimony, and
7 misstatement of this document. If you can answer that,
8 Doctor, go ahead.
9 THE WITNESS: I've not seen this document
10 before, so I don't know where Stephen Olson was headed.
11 But related to your comments that if there
12 were many patients who were enrolled in CAFE, that then
13 they would, they were enrolled in CAFE, or the other
14 study, CATIE, when they were done with that study, then
15 they could be considered for these studies.
16 BY DR. BARDEN:
17 Q Next page, UM CAFE 0721, bottom right. I'll say No. 7.
18 A Which number?
19 Q Right bottom of 7 there. Letter from Jean Kenney. Do
20 you see that? To Jody Robertson in North Carolina.
21 A Yes.
22 Q Okay. Last few sentences here, "We did receive the
23 wonderful basket with the mugs and other goodies.
24 Everything is wonderful and is much appreciated. Looking
25 forward to receiving the chocolates, etc. to thank
218

1 referral sources."
2 Is that your understanding it's a common
3 practice to send thank you gifts for referral sources?
4 A No, it's not my understanding.
5 Q Have you ever done that in any of your studies?
6 A Yeah, I think I may have in the past. I have a
7 recollection of, during the mid-'90s, of visiting a
8 community mental health center and providing a luncheon
9 for them for collaborating with us.
10 Q How about mugs and other goodies?
11 A No, I don't think I've ever done that. I don't recall
12 ever doing that.
13 Q And you've never done the other for the last seven years.
14 Is that correct?
15 A That's correct.
16 Q Next page, page at the bottom right UM CAFE 0728, 8.
17 Study from the CAFE, Jody Robertson, project manager.
18 "Dear Study Coordinators & Principal Investigators.
19 Within this box are the CAFE goodies that we have been
20 discussing in our recent teleconferences. These are to
21 be used as small tokens of appreciation for any referring
22 clinicians. Within you will find: Individually wrapped
23 CAFE M & M packets, CAFE Post It Notes, informational
24 brochures on Schizophrenia from NAMI, CAFE pens. You may
25 request additional items listed above by sending ...
219

1 e-mailed request[s] to" Jody Robertson. "Please contact
2 me with any questions or comments." Have you ever seen
3 this letter before today?
4 A No.
5 Q Were you aware that the CAFE study was giving CAFE
6 goodies out?
7 A No.
8 Q By the way, it says informational brochures on
9 schizophrenia from NAMI. You've been affiliated with
10 NAMI in the past, haven't you?
11 A I'm a member of NAMI.
12 Q Have you ever done any work for them or consulting?
13 A Yes, I have.
14 Q Do you know where the money for NAMI comes from,
15 Dr. Schulz?
16 A My understanding was that the vast majority of the money
17 for NAMI comes from donations of family members who have
18 a family member with a mental illness.
19 Q And who told you that?
20 A I don't recall.
21 Q Do you recall ever seeing any printed documentation of
22 the percentage of NAMI funds that come from drug
23 pharmaceutical companies?
24 A No.
25 Q Have you seen any of that in the national media?
220

1 A No.
2 Q Okay. Next page, 9 at the bottom right, UM CAFE 0767,
3 from Jean Kenney. See right in the middle of the page,
4 September 3, 2002. "Hi Jody, I'm from Dr. Stephen
5 Olson's site at the University of Minnesota. I was not
6 notified of the CAFE Coordinator Teleconference. I
7 started here just as our site got up in June and we have
8 definitely been struggling to get patients. None of the
9 recruitment really started until after I got here and got
10 trained in so hopefully the work I've been putting in the
11 last few months will start to pay off." Have you ever
12 seen that e-mail before today?
13 A No, I haven't.
14 Q Next page, UM CAFE 0792. In the middle there, quoting
15 Jean Kenney. "Hello Dr. McEvoy. Subject DAD was
16 hospitalized --"
17 A It's pronounced McEvoy.
18 Q McEvoy. Thank you.
19 A You're welcome.
20 Q "Subject DAD was hospitalized 4/3/04 after rapid
21 decompensation. As this was a weekend, Dr. Olson was not
22 aware until Monday a.m. He was given 5 milligrams
23 Zyprexa on 4/3 and 4/4. It was discontinued on 4/5 by
24 Dr. Olson and he was restarted on CAFE meds which he was
25 initially refusing. An IM Geodon 20 milligrams PRN order
221

1 was written on 4/8 for agitation if refusing oral meds
2 and unable to be re-directed." Had you seen this note
3 before today?
4 A No, I haven't.
5 Q In the middle, it says, "At this point we believe, DAD
6 was not taking the CAFE medications as prescribed and are
7 hopeful he will respond to them as well as he did when he
8 initially started the study."
9 When you know that 80 percent, according to
10 the CATIE study, that 80 percent of the people taking
11 Seroquel will discontinue that, is that a big surprise
12 when someone stops taking it?
13 MR. ALSOP: Object as vague, but go ahead.
14 THE WITNESS: No.
15 BY DR. BARDEN:
16 Q It's not a surprise, is it?
17 A No. I think we talked before that actually the
18 discussion of the CATIE study was to alert the field that
19 people are changing their medicines or wanting to try
20 something different or stopping much more frequently than
21 the field thought.
22 Q And that some 82 percent on Seroquel will discontinue?
23 A Uh-huh.
24 Q How much is a blood test, to test the level of Seroquel
25 in someone's bloodstream, how much does that cost?
222

1 A I don't have any knowledge of that.
2 Q Okay. Next, UM CAFE 2354, next page, bottom. There you
3 go. The top, it says date, Friday, 24th September 2004.
4 "Joellen, I need your assistance in dealing with MW, the
5 mother of our subject who continues to bother my staff
6 regarding her son's records. She apparently doesn't
7 believe she has obtained all the records even though we
8 have given her everything we have, except the raw data
9 files from the study." Have you seen this note before
10 today?
11 A Nope.
12 Q The bottom paragraph, "I also heard from Dr. Schulz that
13 the legal management of this case that has to do with the
14 research study will not be handled by UMP, but by the
15 University, since it is self-insured. Who should we be
16 communicating with about this?"
17 So did you have a discussion with Dr. Schulz
18 about the legal management -- wait a minute. With
19 Dr. Olson, about the legal management of the case?
20 A Yes, I did.
21 Q And you told him it would be handled by the University,
22 since they're self-insured?
23 A That's not what I told him.
24 Q Really. What did you tell him?
25 A Yes. What I told him was that, to my knowledge at that
223

1 time, that the way our practice plan, our University was
2 set up, that if there was an untoward event or if there
3 was litigation regarding a research study, that the
4 defense of that would be done by the University. If a
5 person had an untoward event and litigation, and the
6 person was in the clinic and not involved in research,
7 that the defense would be done by University of
8 Minnesota Physicians. So I was informed of that at some
9 point probably in the summer of 2004, discussed that with
10 Dr. Olson. This part about since it is self-insured, I
11 didn't say anything to him about that.
12 Q Okay, and at that point, Dr. Olson had not told you that
13 he was the sole and only physician treating Dan
14 Markingson above and beyond the research study, correct?
15 A Correct, that's right.
16 Q Okay. On page 13 on the bottom right, UM CAFE 2356, to
17 Jennifer Frantz from Jean Kenney?
18 A Where?
19 Q Subject -- I'm sorry we're on right here (indicating).
20 See where it says to Jennifer Frantz?
21 A Yes.
22 Q Okay. At the bottom it says Jeannie Kenney. Subject,
23 this is in regarding subject 13. Do you see the 13 on
24 the end of that number?
25 A Yes, I do.
224

1 Q That's Dan.
2 A Uh-huh.
3 Q "I know this has been a nightmare for all of you...I
4 forwarded your e-mail to Ruth Flynn who is an attorney
5 working in our Risk office and have asked her to respond
6 about what we need to do with mom now that she has the
7 records. My instinct is that we need to tell her to stay
8 away, but Ruth will call you. Joellen Johnson, Patient
9 Relations." Have you seen this e-mail before today?
10 A No, I have not.
11 Q Okay, on page 19, on the bottom right. On the bottom
12 right, handwritten number 19. UM CAFE 2362. "Shirley
13 Qual, Esquire, Director of Compliance, Risk Management
14 and Regulatory Affairs. I spoke to Mr. Dunder after I
15 received --" well, this is from Steve, Steve Olson?
16 A Okay. I'm sorry. Where are we?
17 Q Right in the middle here (indicating).
18 A We're on Steve's note, not to Shirley.
19 Q Steve Olson's note, Associate Professor of Psychiatry.
20 "I spoke to Mr. Dunder after I received this message and
21 he indicates he is the appropriate person to act as a
22 buffer with MW. He needs to see all of the material that
23 MW is requesting, and as you told me later today, she has
24 only the clinical notes, not the 1000+ pages of the
25 resource source documents which I thought we had sent
225

1 her. You should send Mr. Dunder the stuff that MW
2 already has a copy of and a sample of the other pages
3 (maybe all the source docs for his last visit, for
4 example) and email him the neurocog files. He then can
5 decide if he wants to see all the research file before
6 discussing that with Astra-Zeneca legal and Quintiles.
7 Steve." Have you seen this e-mail before today?
8 A No, I have not.
9 Q Okay. Next page, 20 on the bottom right. "Dear
10 Ms. Siegel." From Steve Olson. "I have received your
11 letter of June 22 requesting a response to the letter
12 from the State ombudsman regarding the death of subject
13 13 in the CAFE study ... I need more time to prepare a
14 response to the many issues raised and also would like to
15 appear before the executive committee to address any
16 additional questions that may arise. I request this to
17 be postponed from today's meeting to the meeting on
18 August 1, and confirm that I will attend that meeting.
19 Please let me know where the meeting will be held."
20 Did Dr. Olson consult you at all regarding
21 the letter he wrote to the ombudsman's office?
22 A No, he didn't.
23 Q Hypothetically, if a letter written by Dr. Olson
24 contained demonstrably false, deceptive, and misleading
25 important information, would you be concerned?
226

1 MR. ALSOP: Object as assumes facts not in
2 evidence, misstatement of the facts, and vague and
3 ambiguous. Go ahead.
4 MS. AHMANN: Join.
5 THE WITNESS: If that were so, then I would
6 be concerned. It was --
7 MR. ALSOP: You answered the question.
8 THE WITNESS: Just was wondering if we can
9 take just a little --
10 DR. BARDEN: Sure, you bet.
11 THE WITNESS: -- biobreak.
12 (Brief recess taken.)
13 DR. BARDEN: Back on the record?
14 BY DR. BARDEN:
15 Q Looking at this stack, right?
16 MR. ALSOP: I think we had marked a
17 different one as Q.
18 DR. BARDEN: That's fine. We can do that
19 one. That's been marked as Exhibit Q.
20 (Schulz Deposition Exhibit Q marked for
21 identification.)
22 BY DR. BARDEN:
23 Q Doctor, if we can go quickly through Exhibit Q. You'll
24 see the page numbers on the bottom right handwritten.
25 I'll try to move you through it.
227

1 A Okay.
2 Q On page 1, do you see where it says Quintiles, Inc., at
3 the top?
4 A Yes.
5 Q "Request for investigator payment, IRB reimbursement?"
6 A Yes, I do.
7 Q The amount is $1500.
8 A I see that.
9 Q And in the middle of the page, it says, "Sponsor:
10 AstraZeneca." Do you see that?
11 A Yes.
12 Q And "Investigator: Stephen Olson?"
13 A Yeah.
14 Q "Reason for payment: IRB REIMBURSEMENT." Is it your
15 understanding that IRB's responsible -- the reimbursement
16 is by IRB's for their work?
17 A I have seen payment to our IRB for other studies. No, so
18 this doesn't surprise me.
19 Q Next page, page 2, UM SPA 0236. "Principal
20 Investigator/Program Director, Stephen C. Olson." Do you
21 see that at the top?
22 A Yes, I do.
23 Q Looks like a grant, doesn't it? "Personal
24 justifications, Olson, principal investigator,
25 Dr. Olson-8% effort." Do you see that?
228

1 A Yes.
2 Q Okay. "Will supervise the personnel activities of the
3 CAFE project and take primary responsibility for assuring
4 the training and supervision of the staff." That's what
5 he did, right?
6 A Yes.
7 Q Okay. Then do you see your name down --
8 A Yes, yes I do.
9 Q "Schulz, Co-Investigator ... 10% effort." Quote, "Will
10 assist in the training and supervision of the staff.
11 Will work with the entire team to develop and implement
12 recruitment and follow-up care of patients in the
13 protocol." You did not do that, correct?
14 A That's correct.
15 Q Do you feel like when you agreed to do this, you had a
16 contract with the IRB and the paying agencies to do this
17 or not?
18 A Well, I didn't receive any money, so I didn't feel I had
19 a contract for payment, and my understanding was that I
20 was to be available to Dr. Olson for these activities.
21 Q But if IRB approved this and if the sponsor paid for it
22 based on the supposition that experienced Dr. Schulz
23 would be assisting and watching over Dr. Olson and
24 assisting in the training and supervision and recruitment
25 and follow-up care, and you in fact were not involved in
229

1 those things, you don't feel like they were misled?
2 MR. ALSOP: That's a multiple question,
3 misstatement of the facts, and argumentative, but go
4 ahead. Also foundation as to what they felt. Go ahead.
5 THE WITNESS: So, no, I don't think I misled
6 them, and my understanding with Dr. Olson was that I
7 would be available to him to cover if he called upon me
8 and needed help with training of the staff, I would be
9 available to do that, and that was a large part of the
10 rationale why I did not accept any portion of my salary
11 to be paid from CAFE.
12 BY DR. BARDEN:
13 Q Isn't it particularly troubling, given that this lawsuit
14 is mostly focused on failures of recruitment and
15 follow-up care of patients, the two things that you were
16 going to be involved in assisting with, but didn't?
17 MR. ALSOP: Object as argumentative, form of
18 the question, with the assumptions you've made, but go
19 ahead, comments. Go ahead.
20 THE WITNESS: I'm sorry again to ask you to
21 ask me the question.
22 BY DR. BARDEN:
23 Q You were supposed to help with implementing recruitment,
24 right?
25 A I have said that I was available to Dr. Olson to help.
230

1 Q Yeah. A lot of the allegations in this lawsuit involve
2 improper recruitment, violations of informed consent, and
3 coercion, correct? Those are the allegations, correct?
4 A Those are the allegations.
5 Q Okay, and also a failure to follow up a grossly psychotic
6 patient and notice they were suicidal and get them proper
7 treatment. That's another allegation, correct?
8 A It is, but -- it is.
9 Q And these were the two parts of the study that you were
10 going to assist with, correct?
11 A Uh-huh. As I've said before, I was available to
12 Dr. Olson if he called upon me for help in these areas.
13 Q That's not what it says in this document. Doesn't say
14 that at all, does it?
15 A No, it's not what it says in the document.
16 Q It says "will assist," doesn't it?
17 A Yes, it does.
18 Q But you didn't assist, did you?
19 A Correct. He did not call upon me to help him.
20 DR. BARDEN: Move to strike the rest of the
21 nonresponsive answer.
22 BY DR. BARDEN:
23 Q Does it say will assist when Dr. Olson calls upon him?
24 Does it say that?
25 MR. ALSOP: Wait, wait, wait. Stop.
231

1 BY DR. BARDEN:
2 Q I'm asking you what it says in the document.
3 MR. ALSOP: You've read it two or three
4 times. You've asked him what it says two or three times.
5 One more time and we're not going to answer any
6 questions. One more time.
7 BY DR. BARDEN:
8 Q It does not say will assist when calls, does it?
9 MR. ALSOP: Objection, repetitious. The
10 document speaks for itself.
11 THE WITNESS: No.
12 BY DR. BARDEN:
13 Q Next page, "Departmental Internal Peer Review. Principal
14 Investigator: Stephen Olson. Co-Investigators: Charles
15 Schulz and John --" how do you say that?
16 A Vuchetich.
17 Q Vuchetich, okay. So do you see there is a faculty effort
18 certification, percent of effort, this is for Olson, is
19 eight percent, correct?
20 A Yes.
21 Q You see where it says percent of salary, eight percent?
22 A Yes. No. Let me see, percent --
23 Q S-a-l-a-r-y, correct?
24 A You're kind of looking at the whole page here. Do you
25 mean No. B?
232

1 Q Yes.
2 A 1(b).
3 Q Yeah. It says percent of salary, correct, eight percent?
4 A That's correct.
5 Q Thank you. Next page, 4 at the bottom. "Principal
6 Investigator: Stephen Olson, M.D." Do you see that?
7 A Yes, I do.
8 Q It says, "Breakdown of Payments, initial payment,
9 $16,362," correct?
10 A That's correct.
11 Q It says, "Upon receipt and approval of all regulatory
12 documents and this signed Clinical Study Agreement,
13 AstraZeneca shall forward a payment of $16,362 to the
14 representative noted below. This Initial Payment is a
15 refundable, advance payment for the first patient
16 enrolled and will be deducted from future Per Subject
17 Payments. If Institution does not enroll at least 1
18 Subject into the Study within 8 weeks of the date of its
19 receipt of the Study Drug, this Agreement may be
20 immediately terminated by AstraZeneca, and Institution
21 shall refund to AstraZeneca the $16,362 Initial Payment."
22 Did I read that correctly?
23 A Yes, you did.
24 Q And that's your understanding of the agreement you had,
25 correct, the CAFE study?
233

1 A Yes, it is.
2 MS. AHMANN: Objection --
3 BY DR. BARDEN:
4 Q Next, page 5 at the bottom right. We'll be looking at
5 pages 5 through, 5 through 14 as the AstraZeneca clinical
6 study agreement. Between -- if you see UM SPA 0076,
7 page 5 at the bottom right?
8 A Yes, I do see that.
9 Q At the top it says, "This CLINICAL STUDY AGREEMENT ...
10 dated as of the last date of the signatures below, is by
11 and among AstraZeneca Pharmaceuticals, LP, a Delaware
12 limited partnership with offices at 1800 Concord Pike,
13 Wilmington, Delaware ... ('AstraZeneca'), and The Regents
14 of the University of Minnesota, a Minnesota corporation
15 ('Institution') ... with Stephen Olson ... as ('Principal
16 Investigator')." Is that your understanding of the
17 parties to this agreement?
18 A Yes, it is.
19 Q Okay. On the next page, page 6 at the bottom,
20 UM SPA 0077. Right in the middle of the page, it says,
21 "Principal investigator --"
22 A Would you give me the letter?
23 Q Sorry. B, 5(b).
24 A Okay.
25 Q "Principal investigator shall obtain the informed consent
234

1 of each of the Subjects prior to any screening or
2 participation in the Study and in accordance with
3 Applicable Laws. An informed consent form that has been
4 reviewed and approved by AstraZeneca shall be completed
5 for each Subject." Did I read that correct?
6 A You read it correctly.
7 Q Is that your understanding of the contract for the CAFE
8 study?
9 MS. AHMANN: Object, lack of foundation.
10 THE WITNESS: I'm looking at this for the
11 first time, so yes, it is my understanding of the
12 contract. I kind of looked at the back to check and see
13 if it was signed and who signed it. So it looks like the
14 contract.
15 BY DR. BARDEN:
16 Q Okay. Page 11. See where it says, "Indemnification by
17 AstraZeneca," do you see that clause?
18 A Yup.
19 Q Have you had that in other contracts?
20 A I would respond in general that there is frequently some
21 discussion of indemnification for the studies that the
22 departments and the med school do with the district.
23 Q Have you seen any mutual indemnification agreements in
24 this case?
25 A I haven't, no.
235

1 Q Okay. This one says that AstraZeneca will defend,
2 indemnify and hold harmless for damages caused by the
3 administration of the study drug. Were you aware that
4 when Dan Markingson died, he had no drug in his
5 bloodstream, no Seroquel?
6 MR. ALSOP: Doctor, from other sources other
7 than me, you can answer the question. Anything from what
8 you learned from me, don't respond to. If you learned
9 about that issue from other sources, go ahead and answer.
10 THE WITNESS: No, I was not aware of that,
11 other than from --
12 MR. ALSOP: That's it.
13 BY DR. BARDEN:
14 Q Would it surprise you if I told you that the blood test
15 taken at autopsy showed zero Seroquel in Dan Markingson's
16 bloodstream?
17 MR. ALSOP: That's irrelevant, lacking
18 foundation, but go ahead.
19 THE WITNESS: So the question is that --
20 BY DR. BARDEN:
21 Q Would that surprise you, since 82 percent of people
22 discontinue taking Seroquel, is that surprising that he
23 had no Seroquel in his bloodstream?
24 A I'm sorry, I was attempting to answer your first
25 question. So the question, as I heard it, was whether I
236

1 was surprised that there was no Seroquel in his
2 bloodstream.
3 Q Uh-huh.
4 A And without knowing the sensitivity of the assay used or,
5 you know, how long after he died the postmortem was done
6 and the blood sample was collected, when his last dose
7 was before he died, I would have to say it is surprising
8 in some ways, but without that information, I can't make
9 a determination or an assessment.
10 DR. BARDEN: Let's go to the next one, which
11 is -- let's start with this one. See where it says,
12 "Thanks for sending that info."
13 MR. ALSOP: Okay.
14 DR. BARDEN: UM CAFE 0565.
15 (Schulz Deposition Exhibit R marked for
16 identification.)
17 BY DR. BARDEN:
18 Q Let's look at page 1, Doctor, on the front there. It
19 says, second sentence, "Regarding the proposed thank you
20 gift, Tina Olexy at AZ." That would be AstraZeneca,
21 correct?
22 A I believe so.
23 Q "Has agreed to reimburse your site for the full $400 cost
24 of the booth." Did drug companies reimburse you for
25 booths at meetings in your previous studies?
237

1 A I haven't personally used booths at meetings, but
2 Dr. Olson and his clinical research group working with
3 patients with serious psychiatric illnesses would on
4 occasion create a booth that described the research
5 opportunities for people, give them information about
6 what was going on at the University, and so that's what I
7 speculate this is about.
8 Q Okay, and it goes on to say, "As for the CAFE brochures,
9 M&Ms, pens and Post It Notes, I'm glad you were able to
10 track those down, even if it was a wild goose chase."
11 Have you seen this e-mail before today?
12 A No.
13 Q Next e-mail to Jean Kenney from Jody Robertson, et al.
14 Just we're on the same page. It says, in the middle it
15 says, "Elizabeth and I made an executive decision about
16 what we would like as a Thank You for the recruitment
17 presentation. To offset the cost of our booth and to buy
18 chocolates to attract folks to us we'd like to ask for a
19 monetary gift. Not knowing exactly what is reasonable we
20 are throwing out $200.00. Our booth costs about $400 and
21 we spent about $80.00 on candy last year. Any idea when
22 we might receive the brochures and other CAFE items
23 (pens, post-it's, etc.)? We did receive our sweatshirts
24 today. Thanks so much. They are really nice. Thanks
25 for your support with this. We hope it brings a lot of
238

1 referrals."
2 Have you ever had study sweatshirts before?
3 A You know, I don't recall ever handing out study
4 sweatshirts, but I have heard about other studies in
5 which T-shirts about the study or something like that
6 have been given to patients.
7 Q Next page, page 2, to Amy from Jeannie Kenney. "Hi Amy.
8 Attached you'll find the most recent ICFs. The IRB
9 really got mixed up with approving the protocol change
10 and so it wasn't until actually just this last week that
11 we received final approval. They approved the consents
12 before approving the protocol. I now need to go back and
13 have everyone else sign new consents so they are
14 officially informed of the protocol change." Have you
15 seen this e-mail before today?
16 A No, I haven't.
17 Q Next page. Did you ever pay for private limousines for
18 patients to come in to be subjects in your study? Did
19 you ever pay for private limousines?
20 A We paid for, there was a car service that provided more
21 reliable pickup of some of our patients at agencies
22 around town, so I was aware of a car company. I didn't
23 know it was a limousine company.
24 Q Okay. Page, we're on page 3 here.
25 A Uh-huh.
239

1 Q Bottom of the page, again, Jeannie Kenney and Jennifer
2 Frantz. "Depending on the mileage it would be between
3 $30 [and] $50. One of [the] other studies is using this
4 service. It was more cost efficient than cab fare and
5 it's more comfortable as the [patients] are picked up in
6 pretty nice vehicles. [It] kind of makes them feel
7 important. Jeannie." Have you ever seen that e-mail
8 before today?
9 A No, I haven't.
10 Q Okay. Next, page 4, letter April 25, 2003, from Jeannie
11 Kenney to Quintiles. "Please find enclosed a receipt for
12 refreshments. Our CAFE team presented information about
13 the study at a private psychiatric outpatient clinic in
14 the area." Have you ever seen this letter before today?
15 A No, I haven't.
16 Q Next page. From Jeannie Kenney to Monica Pallett. Who
17 is that? Do you know where she is?
18 A No. It sort of looks like she's at the University of
19 North Carolina.
20 Q Okay. With regard to the "CAFE PANSS Rater Certification
21 Status." E-mail says, "Hi, I went back and saw that in
22 September of last year," that would have been '03,
23 September of '03, "Dr. Olson was reminded he was only
24 certified for CATIE PANSS, not CAFE and that he would
25 need to view the vignettes online. [It] looks like he
240

1 did not do that. I have reminded him of this."
2 Were you ever aware that there was a problem
3 with Dr. Olson not being properly certified for doing the
4 PANSS on CAFE?
5 A No.
6 Q Next page, page 6. This is March 2004. "Hi Jeannie,
7 Dr. Olson has not viewed the Jose tape and still needs to
8 do so for CATIE. However, he has never become certified
9 as a PANSS rater for CAFE and therefore should NOT be
10 rating the PANSS for CAFE. If he is doing so, or plans
11 to do so, he needs to go on the CAFE website and score
12 those three tapes ASAP." Have you ever seen this note
13 before today?
14 A No, I haven't.
15 Q Do you know if Dr. Olson was in fact doing PANSS ratings
16 when he was not properly certified?
17 A No. I don't have any information about that.
18 Q Dr. Olson ever come to you and say I'm not rated on PANSS
19 yet?
20 A No, he did not.
21 Q Last page, page 8, of what's been marked as Exhibit R.
22 Letter from the University of North Carolina. Do you see
23 this document?
24 A Yes, I do.
25 Q From Jeffrey Lieberman, correct?
241

1 A Yes.
2 Q It says, "CAFE Enrollment Kickoff. Dear Colleagues,
3 We've now worked together on the CAFE project for almost
4 two years. Our common goal is to complete the study
5 successfully and provide data that will answer critical
6 questions about the use of atypical antipsychotic drugs
7 in patients in their first psychotic episode. I thank
8 you for your superb efforts in making this trial possible
9 and successful to date. Although recruitment has
10 recently gone quite well, we still must consider the risk
11 for not meeting our target of 400 subjects. As of
12 Sunday, November 30th, 2003, we have enrolled 328
13 subjects out of our target 400. There are only 13 weeks
14 left to enroll subjects and there is no possibility of
15 further extending the enrollment period. We have been
16 averaging 20 new subjects a month for the past 6 months
17 now but we need to enroll about 25 per month for the
18 remainder of the trial. If each site can enroll 1
19 patient per month in the remaining 3 months then we will
20 meet our goal. I encourage you to make every effort to
21 enter patients into CAFE in this final stage of
22 enrollment. With a little extra effort, we will
23 succeed." Have you seen this letter before today?
24 A No, I have not.
25 Q Does this give us some idea of the kind of pressure,
242

1 intense pressure on people to enroll subjects in the CAFE
2 study?
3 MR. ALSOP: Object as argumentative,
4 misstatement of the document, lacking in foundation. Go
5 ahead.
6 MS. AHMANN: Join.
7 DR. BARDEN: Strike that. I'll ask more
8 specific questions.
9 BY DR. BARDEN:
10 Q Does it say in the letter they have worked on CAFE for
11 almost two years?
12 A That's what the letter says.
13 Q Research studies can take a lot of time and effort, can't
14 they, Doctor?
15 A Yes, they can.
16 Q Does this say there are only 13 weeks left to enroll
17 subjects with no possibility of further extending the
18 enrollment period?
19 A Yeah. That came about two-thirds of the way down, that's
20 what the sentence says.
21 Q So there are deadlines in some of these studies, aren't
22 there?
23 A Yes, there are.
24 Q And the deadlines involve a loss of funding, isn't that
25 right, potentially a loss of funding, as we've seen in
243

1 the other contract? Isn't that right?
2 A Well, I can't say what the implications for Dr. Lieberman
3 would be vis-a-vis funding.
4 Q Okay. So go to this one. It says, "Coordinator call
5 minutes" at the top.
6 MR. ALSOP: What does it say on the top? I
7 missed that.
8 DR. BARDEN: "Coordinator call minutes." If
9 not, we'll just go through it quickly.
10 MR. ALSOP: Let me see what it says.
11 DR. BARDEN: "Coordinator call minutes."
12 MR. ALSOP: There it is. Okay.
13 (Schulz Deposition Exhibit S marked for
14 identification.)
15 BY DR. BARDEN:
16 Q Page 1, in the middle there it says question. "Can we
17 enroll a patient who has [four to five] months of
18 previous treatment?"
19 A I'm sorry, where are we now?
20 Q Right here (indicating). Four to five months of previous
21 treatment. "Yes, but document it and send Joe McEvoy
22 notification."
23 A Uh-huh. I'm sorry for this. Just orient me to the
24 document a little bit.
25 Q This is UM CAFE document 0422.
244

1 A And it is, it says, "Coordinator call minutes?"
2 Q That's what it looks like, uh-huh.
3 A Okay.
4 Q I'm asking you a specific question about this statement
5 in here that they can enroll a patient with four to five
6 months of previous treatment. What was your
7 understanding of the CAFE protocol with regard to
8 previous treatment? How long could someone be in
9 treatment previously before they weren't enrolled?
10 A My recollection of presentation of the study is that I
11 believe it was about 12 weeks of antipsychotic medication
12 treatment.
13 Q Okay, and how long could someone have been psychotic
14 before they could be enrolled in the study?
15 A I can't remember exactly, but my speculation is about two
16 years.
17 Q And that's what it says in the protocol, to the best of
18 your knowledge.
19 A To the best of my knowledge.
20 Q Okay. See in the bottom of page 1, it says, "Advertise
21 in free" newspapers, "free papers. Directing the ads to
22 both doctors and potential patients. Stress the high
23 quality care that patients will receive as a perk to any
24 referral." Have you seen that before today?
25 A No, I have not.
245

1 Q Did you ever recruit any subjects for the CAFE study?
2 A I don't believe so.
3 Q Have you ever stressed to a potential subject that they
4 would receive perks for -- well, have you ever told any
5 referring physicians that as a perk, they would receive
6 high-quality care?
7 MR. ALSOP: Object as vague, but go ahead.
8 THE WITNESS: Over my career in clinical
9 research, I'm sure I've discussed with my colleagues that
10 my belief was that participation in some trials would
11 lead to an excellent evaluation, sustained attention,
12 perhaps some of the laboratory tests or imaging leading
13 to discovery of other illnesses that they hadn't been
14 screened for, and that it could be a useful thing for a
15 patient to participate in clinical research, so --
16 BY DR. BARDEN:
17 Q Sure.
18 A I've said that.
19 Q Sure. If the study is competently done, it can be quite
20 helpful, correct?
21 A Yes.
22 Q The study's incompetently done, it can be quite harmful,
23 correct?
24 MR. ALSOP: It's argumentative, vague and
25 ambiguous. Go ahead.
246

1 THE WITNESS: Yes.
2 BY DR. BARDEN:
3 Q Let's look at page 4, middle there to Jody Robertson from
4 Jeannie Kenney. "Thank you all very much for your
5 generosity. I really hope we can give a report that
6 we're getting 50 CAFE referrals out of this. Gotta think
7 positively. I will get the invoice together and forward
8 [it] to Marie asap." Have you seen this note before
9 today?
10 A No. I'm sorry. I just wanted to kind of like get caught
11 up here. So this is to Jody, as well as Jennifer Frantz
12 and Christina Olexy, or something like that, copied to
13 Elizabeth Lemke.
14 Q And Lemke was on the study too, correct?
15 A Yes, she was. The subject is "Jody's address?" And it's
16 from Jeannie.
17 Q Uh-huh.
18 A Okay.
19 Q She wants --
20 A Tell me again what the question is. I just want to make
21 sure I understood what we're talking about.
22 Q Yeah. She says, quote, "Thank you all very much for your
23 generosity. I really hope we can give a report that
24 we're getting 50 CAFE referrals out of this. Gotta think
25 positively. I will get the invoice together and forward
247

1 [it] to Marie asap." The question is, have you seen that
2 before today?
3 A No.
4 DR. BARDEN: Next let's look at this one.
5 It says CAFE on the top.
6 (Schulz Deposition Exhibit T marked for
7 identification.)
8 BY DR. BARDEN:
9 Q See at page No. 1 where it says, "Recruitment
10 information, new ideas [and] requests?" Do you see that?
11 We're on the same page?
12 A No. 2?
13 Q Yeah. My question, it says, "CAFE Coordinator
14 Teleconference." Did you ever participate in any of
15 these?
16 A I don't think so, no.
17 Q Next page, No. 2, these are the minutes of the
18 October 2003 meeting, you see that, handwritten notes?
19 A Uh-huh. Do you know whose notes these are?
20 Q I don't, unless it says it on here. It says, "CAFE
21 Teleconference: Coordinators. Last month: 27
22 enrolled ... October so far: 12 enrolled ... CAFE
23 web cast meeting October 29th."
24 This is during that time period, was it not,
25 when Dr. Lieberman had wrote that they felt like their
248

1 time was running out, they were under some considerable
2 time pressure to recruit subjects, correct?
3 A Looks like it's a little more than two months before
4 Dr. Lieberman's note.
5 Q Okay. Same -- it was fall of 2003.
6 A This is dated fall of 2003.
7 Q Right. Next page, 3, "CAFE Study Coordinator
8 Teleconference, August 14th, Recruitment Report." Now,
9 under Roman numeral II under recruitment report, it says,
10 "Inpatient/Outpatient Recruitment. Newly added 16-bed
11 psychosis-specialty unit." When did that unit open?
12 A You know, I can't remember exactly. My estimate is maybe
13 in the spring of 2003, or sometime in 2002.
14 Q Uh-huh. It says, "All nurses, case managers and staff
15 are educated, aware and supportive of research. All
16 patients are reviewed for possible research candidacy.
17 Research staff are in contact with nurses, case managers,
18 and attending psychiatrists daily."
19 Were the patients informed that their nature
20 of their illness and their problems might be reviewed by
21 a research staff outside the treatment staff?
22 A My recollection is, yes, they were, and that there was a
23 form developed, along with approval by the hospital, that
24 would go on the front of the chart so that the attending
25 psychiatrist could look at that and then sit and discuss
249

1 with the patient the options for clinical research.
2 Q Okay, so it's your testimony that there is a form signed
3 in the patient's medical records where they know research
4 people will be reviewing their files?
5 A I didn't say that.
6 Q Okay.
7 A What I did say is, to my recollection of this era, that
8 the hospital worked with some of the faculty to develop a
9 form that went in the front of the chart to alert the
10 attending psychiatrist of the potential for a patient to
11 participate in research. If the psychiatrist, the
12 attending psychiatrist, then looked at this form and went
13 and talked to the patient about it and they, and then
14 decided to refer, then the patient could be approached
15 for the study. If the psychiatrist felt that he did not
16 want his patient in the study, then the patient was not
17 referred.
18 Q Uh-huh. But doesn't it seem like Jean Kenney knows facts
19 and particular details about these people that she's
20 e-mailing around and they're still potential subjects who
21 haven't written any consent forms?
22 MR. ALSOP: I'll object as vague and
23 ambiguous, form of the question.
24 THE WITNESS: I'm sorry, I'm not following.
25
250

1 BY DR. BARDEN:
2 Q Okay. In the e-mails we've seen, were there not some
3 subject information, some information about people, their
4 parents said no?
5 A Oh, yes.
6 Q He was discontinued from the medication?
7 A Right.
8 Q Jean Kenney's e-mailing this off, and what was --
9 A Let me go back --
10 Q To the best of your knowledge, what kind of permission
11 did she have to do that?
12 MR. ALSOP: That's lacking in foundation --
13 BY DR. BARDEN:
14 Q That is, sending e-mails with containing the facts of
15 people's lives?
16 MR. ALSOP: It assumes facts not in
17 evidence, object to the form of the question,
18 speculative, and lacking in foundation. Go ahead.
19 THE WITNESS: So I described my
20 understanding of how things were proceeding on the
21 psychosis specialty unit, and that the, that
22 investigators would put a note in the front of the chart
23 for the attending psychiatrist to approach a patient, and
24 they could either refer or not refer. If they were
25 referred, then Jeannie could approach the patient and
251

1 begin to discuss with them whether or not they would like
2 to participate in the research or not. Regarding the
3 person you described who discontinued the medication, my
4 understanding that person was already in the study.
5 BY DR. BARDEN:
6 Q So Jeannie could approach them based on the say-so of the
7 doctor.
8 A Correct.
9 Q But the patient was not informed that a research person
10 would now be --
11 A Oh, I'm not --
12 Q Would now be permitted to screen their file?
13 A I'm not being clear then, I'm not being clear then.
14 Jeannie couldn't review the file until -- the note would
15 go in the front of the chart or in that little pocket in
16 the front. It would be to the doctor, and the doctor
17 would say, sit and talk with the patient, you want to be
18 in this project or whatever. The patient said yes. Then
19 Jeannie was allowed to talk with the patient and initiate
20 inviting the person to be in a study.
21 Q But there is no documentation of the patient saying yes,
22 certainly not in Dan's case, correct?
23 A Being -- I'm sorry. No documentation the patient said
24 yes, it's okay for me to talk with somebody?
25 Q That research people will now review my file and --
252

1 A Well, I'm pretty sure that they talked to the patient
2 before reviewing the file. That is my understanding of
3 the process.
4 Q Okay, but there is no documentation of this process, to
5 the best of your knowledge, of that transition?
6 A You know, my best answer would be that I don't know,
7 because I don't know whether the form I just described
8 with you in some way went into the chart, so I can't say
9 what the general process was.
10 Q Okay. Let's look at page 4. "CAFE Coordinator
11 Teleconference, July 10, 2003. Spotlight
12 presentation-Diana Perkins at UNC-Chapel Hill.
13 Strategy 1-Early identification is essential in
14 recruiting patients. One way to implement this is to
15 identify all possible portals for first episode
16 patients ... This is best utilized by having a central
17 study recruiter who can visit these portals daily to
18 review any new admissions and loosely screen for multiple
19 studies including CAFE."
20 This is what I'm talking about, the screen.
21 Someone's going and screening the new admissions. Do the
22 patients know this?
23 MR. ALSOP: Object on the basis of
24 foundation.
25
253

1 BY DR. BARDEN:
2 Q That they're being quote, screened, unquote, "for
3 multiple studies including CAFE?"
4 MR. ALSOP: Same objection, it's foundation,
5 but go ahead if you know.
6 THE WITNESS: Okay. Well, I think this is
7 Dr. Perkins, who works at University of
8 North Carolina-Chapel Hill, giving her opinion, and I
9 told you what our process was, and it looks like it's a
10 little different than the one she's recommending.
11 BY DR. BARDEN:
12 Q Yeah, because this says if a potential patient is
13 identified by the screening, "the recruiter should notify
14 the study clinician who can [then] contact the patient
15 directly." That's not talking to the patient; that's
16 screening. Patient doesn't know.
17 A Yeah, I see that last sentence. I agree with you.
18 Q "Strategy 2-Hold educational seminars on Schizophrenia
19 and the CAFE study. Some suggestions for target groups
20 are the ER and walk-in clinic residents and attendings.
21 This is an opportunity to meet these people and establish
22 a rapport while educating them on CAFE. (Remember, that
23 AZ offers $100 [every] 3 months to support these events."
24 "Strategy 3-During these educational
25 meetings, emphasize the benefits of your site taking on
254

1 the care of these patients. Some of these benefits are:
2 1. the ability to offer the patient immediate care,
3 saving these portals' staff time and effort; 2. assure
4 them that if the patient is not eligible, he or she will
5 be referred to a physician, and if the patient is
6 eligible, he or she will receive outstanding care and
7 free medication."
8 Were you aware that Dan Markingson had
9 health insurance?
10 A No.
11 Q Dr. Olson never mentioned that to you?
12 A Nope, he did not.
13 Q He didn't? Are you aware that a person who is committed
14 and under a stay of commitment, their health insurance
15 has to pay for the treatment that's recommended?
16 A I wasn't aware that that was a routine. I knew that that
17 happened sometimes.
18 Q Were you aware that Dan Markingson was never informed of
19 that?
20 A No.
21 Q And it's certainly not on the informed consent form, is
22 it, that he could have left, gone, and had a totally
23 different treater paid for by his insurance by law?
24 MR. ALSOP: Objection on the basis of
25 foundation, but go ahead.
255

1 THE WITNESS: Make sure I understand the
2 question. You're saying was I aware, do I know whether
3 Dan was ever told that or not?
4 BY DR. BARDEN:
5 Q That's an alternative treatment, isn't it? He could go
6 out and get -- he could have had multiple atypicals at
7 the same time. Can't have that on the study. He could
8 have had Depakote. Can't have that on the study. He
9 could have had a number of things. He could have gone to
10 The Mayo Clinic. His insurance had to pay for it.
11 Nobody told him that. It's not on the informed consent
12 form, correct?
13 MR. GROSS: Objection, multiple.
14 MR. ALSOP: Form of the question, it's
15 multiple.
16 MS. AHMANN: Join.
17 THE WITNESS: I don't believe -- I don't
18 know what he was told about that.
19 BY DR. BARDEN:
20 Q Page 5. Bottom here, it says, "To thank you for your
21 efforts, AstraZeneca is offering to provide a gift to
22 each of your sites. This gift can be anything within
23 reason (gift basket, educational materials/supplies,
24 monetary support for any educational seminars you are
25 giving (beyond the current allotment of $100 [every] 3
256

1 months), etc.) If there are any upcoming
2 seminars/training sessions you are interested in
3 attending, we would also consider picking up those costs
4 within reason. Please think about this offer, and in
5 what way we can best support you, and let me know. We
6 are open to all ideas, and will consider them all." Did
7 you see this e-mail before today?
8 A No, I haven't.
9 Q Did you ever receive a gift from AstraZeneca during your
10 work with them?
11 MR. ALSOP: It's vague.
12 DR. BARDEN: Vague as to gift? Have you
13 ever received a gift from AstraZeneca.
14 MR. ALSOP: No. For the CAFE study or for
15 ever a gift?
16 BY DR. BARDEN:
17 Q Ever.
18 A Ever, yes.
19 Q Have you received one for the CAFE study?
20 A No.
21 Q You received one for something else? What was the gift?
22 A I received a pen from --
23 Q Have you received a gift for recruiting subjects?
24 A No.
25 Q Have you received a gift for a referral?
257

1 A No.
2 Q Were you aware that they were giving gifts to encourage
3 referrals?
4 MR. ALSOP: It's repetitious. Go ahead.
5 THE WITNESS: Well, I may not be
6 understanding this correctly, but my understanding of how
7 this was going is that Jeannie and Elizabeth, or Jeannie
8 and Elizabeth and Steve Olson, would go to a mental
9 health center or some other maybe community education
10 meeting, and they would set up a booth, and they might
11 have a bowl of chocolates or a pen with either
12 University of Minnesota and, it sounds like from here,
13 maybe the CAFE study, and that they would see that and
14 talk either with people in the community or others.
15 That's my understanding of what these materials were
16 about.
17 BY DR. BARDEN:
18 Q Let's go to page 7. "Dear CAFE Investigators, Despite
19 the fact we've made considerable progress in the period
20 since the CAFE investigators' meeting in January [of]
21 2002, for a variety of reasons we are behind schedule on
22 enrollment."
23 A Do you know when this was written?
24 Q I don't. It says January 2002, though. "For this reason
25 I am requesting --"
258

1 A It says since the meeting.
2 Q Yup, that's right.
3 A Like we don't know when that --
4 Q This is a document from the University of Minnesota. I
5 can't add to it or subtract. "For this reason I am
6 requesting that all site investigators and coordinators
7 make every effort to attend the regularly scheduled
8 teleconferences held monthly or bimonthly and
9 particularly the ones this week. The topics discussed
10 will be important in determining the future progress of
11 the study."
12 So was there, to the best of your knowledge,
13 was there a great deal of concern and pressure that they
14 were not recruiting enough people for the CAFE study?
15 MR. ALSOP: It's vague and ambiguous, it's
16 also repetitious, but go ahead.
17 MS. AHMANN: Join, lack of foundation also.
18 THE WITNESS: When I read this letter, it
19 looks like Dr. Jeffrey Lieberman was very concerned about
20 the viability of this study.
21 DR. BARDEN: Let's look at this one. Monica
22 Pallett on the top upper left, it's UM CAFE 0686, and
23 we'll mark it as Exhibit --
24 (Schulz Deposition Exhibit U marked for
25 identification.)
259

1 BY DR. BARDEN:
2 Q Looking at the front part here, again, this is from
3 Monica Pallett to Jeannie Kenney, November 7, 2003.
4 Again, this is about checking on the PANSS certification
5 of Dr. Olson. "He is not certified to rate the PANSS for
6 CAFE and if he is doing so should score all three of the
7 certification tapes ... Also, I just scored his PANSS
8 submission for tape 20 for CATIE ... and he scored it
9 quite low so [he] will need to rescore it."
10 Do they have people rescoring tapes as part
11 of research studies? If the people at the main office
12 think the score's too low, they just have them rescore
13 it? Is that research protocol?
14 MR. ALSOP: It's a misstatement of this
15 document, argumentative, lacking in foundation. Go
16 ahead.
17 MS. AHMANN: Join.
18 THE WITNESS: So I don't know anything
19 specific about this.
20 BY DR. BARDEN:
21 Q Have you ever seen this e-mail before today?
22 A No.
23 Q Would you think it would be appropriate for someone to
24 rescore a PANSS submission because a bureaucrat thinks
25 it's too low?
260

1 MR. ALSOP: Same objections. Go ahead.
2 THE WITNESS: Well, I don't know if Monica
3 Pallett is a bureaucrat or what she does, but --
4 BY DR. BARDEN:
5 Q Whatever.
6 A Okay, whatever. I have participated in startup meetings
7 related to training on PANSS; and for your information,
8 the way it frequently goes is the investigators are in a
9 room and a CD or tape is played. Then the PANSS, or
10 whatever other rating scale, is scored. Then there
11 follows after that a discussion about the range of
12 ratings for some of the individual symptom items, and
13 then sometimes the tape is replayed and people practice
14 again and try to see, you know, where they might have
15 gone off base or something like that, and then frequently
16 another tape is played and the people rate the PANSS
17 again until there is a reasonable agreement in everybody
18 rating what they see.
19 Q Knowing that Dr. Olson was not certified to rate the
20 PANSS for CAFE for quite some time, and as a
21 coinvestigator on that study, what, if any, duty do you
22 have now to go back and look at the data to see if he had
23 done PANSS ratings when he was not certified?
24 MR. ALSOP: Object on the basis of
25 relevancy. Go ahead, Doctor.
261

1 THE WITNESS: I hadn't seen this e-mail
2 before, I wasn't aware of this, and maybe, in the
3 vocabulary of our previous discussions, it's concerning
4 to me, and I would have to look into this further and
5 understand better what's going on.
6 BY DR. BARDEN:
7 Q Okay. Look at page 5. These are vignettes, "CAFE Reason
8 for Treatment Phase Discontinuation Vignettes." This is
9 the last one, No. 9. It says, "After 3 months on the
10 maximum doze of assigned Antipsychotic medication, the
11 patient continues to have delusions that his parents are
12 imposters resulting in continued family conflict. This
13 should be considered: 2. Clinician decision:
14 Unacceptable side effects." Did you ever see Dan
15 Markingson's journals?
16 A No.
17 Q Have you ever read journals kept by paranoids that are
18 grossly psychotic?
19 A Yes, I have.
20 Q Where they write floridly psychotic thoughts and ideas
21 and they keep detailed journals of these. Have you ever
22 had a patient like that?
23 A Yes, I have.
24 Q In fact, there are some paranoids, especially ones that
25 are gifted writers, tend to do that, don't they?
262

1 A That's correct.
2 Q Dr. Olson ever tell you that Dan Markingson kept a
3 detailed journal?
4 A No.
5 Q That it was right there in his room in the Theo House,
6 anybody could have looked at it any time or asked him
7 what was in it, but apparently no one ever did? Did
8 Dr. Olson ever tell you anything about this?
9 A No, he did not.
10 Q All right. Takes care of that one.
11 DR. BARDEN: How much time have I used so
12 far?
13 VIDEO TECHNICIAN: As far as the videotape
14 running?
15 DR. BARDEN: Yes.
16 VIDEO TECHNICIAN: We're about five
17 and-a-half hours, give or take five minutes.
18 DR. BARDEN: Okay, and you know what, we're
19 getting into a whole other one, so I promised you
20 5:00 o'clock. We'll come back and finish the other two
21 and-a-half hours, or whatever I have.
22 MR. ALSOP: I think one and-a-half.
23 DR. BARDEN: One and-a-half. Thanks.
24 MR. ALSOP: Go right ahead.
25 VIDEO TECHNICIAN: I can get the exact time
263

1 for you.
2 MR. ALSOP: Yeah, just give us a time so we
3 can put in the record.
4 DR. BARDEN: Thank you. We'll leave the
5 exhibits with the court reporter and you'll make copies,
6 correct, when you do this? And Doctor, we'll see you
7 next time, and you'll make your dinner.
8 MR. ALSOP: Do you want me to give the ones
9 you have not?
10 (Brief time off the record.)
11 MR. ALSOP: Mr. Barden, I'm just going to
12 put on the record that he confirmed it's five and-a-half
13 hours.
14 VIDEO TECHNICIAN: Give or take five
15 minutes.
16 MR. ALSOP: That's fine. So five and-a-half
17 hours.
18
19 (Deposition adjourned at 4:45 p.m.)
20 * * * *
21
22
23
24
25
264

1 STATE OF MINNESOTA )
)ss. CERTIFICATE
2 COUNTY OF WASHINGTON )
3 BE IT KNOWN that I, Janice L. Young, took the
foregoing deposition of CHARLES SCHULZ, M.D.;
4
That I was then and there a Notary Public in
5 and for the County of Washington and State of Minnesota;
6 That by virtue thereof, I was then and there
authorized to administer an oath;
7
That the witness, before testifying, was by me
8 first duly sworn to testify the truth, the whole truth
and nothing but the truth relative to said cause;
9
That the testimony of said witness was
10 recorded in stenotypy by me and was reduced to type-
writing under my direction;
11
That the foregoing deposition is a true
12 record of the testimony given by said witness;
13 That the cost of the original has been charged
to the party who noticed the deposition, and that all
14 parties who ordered copies have been charged at the
same rate for such copies;
15
That I am not related to any of the parties
16 hereto, nor an employee of any of them, nor
interested in the outcome of the action;
17
That I am not financially interested in the
18 action and have no contract with the parties,
attorneys, or persons with an interest in the action
19 that affects or has a substantial tendency to affect
my impartiality; and
20
That the reading and signing of the foregoing
21 deposition by said witness were waived.
22 WITNESS MY HAND AND SEAL this 30th day of
June, 2007.
23
24 ______________________________
Janice L. Young
25