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STATE OF MINNESOTA COUNTY OF HENNEPIN

DISTRICT COURT

FOURTH JUDICIAL DISTRICT Case Type: Wrongful Death - - - - - - - - - - - - - - - - - - - - - - - - - - - - Court File No. Mary Weiss, on her own behalf, 62-CO-06-11934 and as the next of kin and trustee of the Estate of Dan Markingson, deceased, Plaintiff,

7 -vs8 9 10 11 12 13 14 15 16 17 Date: 18 Commencing at: 9:05 a.m. 19 20 21 22 By JANICE L. YOUNG, RPR 23 24 25 2 12151 Gantry Lane Apple Valley, Minnesota 55124 800-844-6420 * 952-431-1252 June 22, 2007 Board of Regents for the University of Minnesota; Dr. Stephen Olson; Dr. Charles Schulz; Institutional, Review Board for the University of Minnesota; Astrazeneca Pharmaceuticals LP; Astrazeneca LP and Zeneca, Inc., Defendants. - - - - - - - - - - - - - - - - - - - - - - - - - - - - Deposition of: CHARLES SCHULZ, M.D. Taken at: Gislason & Hunter, LLP 701 Xenia Avenue South Suite 500 Minneapolis, Minnesota

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Video deposition of CHARLES SCHULZ, M.D., taken pursuant to Notice to Take Oral Deposition, under the

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Rules of Civil Procedure, for the District Courts of Minnesota, at Gislason & Hunter, 701 Xenia Avenue South, Suite 500, Minneapolis, Minnesota, commencing at approximately 9:05 a.m., on the 22nd day of June, 2007, before Janice L. Young, Notary Public in and for the State of Minnesota. * -

6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 3 Also Present: Mary Weiss Video Technician: Bob Durland BRIDGET M. AHMANN, Esq., of the law firm of Faegre & Benson, 2200 Wells Fargo Center, 90 South Seventh Street, Minneapolis, Minnesota 55402-3901 appeared for and on behalf of Defendants AstraZeneca and Zeneca. DAVID C. HUTCHINSON, Esq., and CHARLES A. GROSS, Esq., Geraghty O'Loughlin & Kenney, 1400 Ecolab University Center, 386 North Wabasha Street, St. Paul, Minnesota 55102-1308 appeared for and on behalf of Defendant Board of Regents of the University of Minnesota. DAVID D. ALSOP, Esq., and ANGELA M. NELSON, Esq., of the law firm of Gislason & Hunter, 701 Xenia Avenue South, Suite 500, Minneapolis, Minnesota 55416 appeared for and on behalf of Defendants Olson and Schulz. RUTH FLYNN, Esq., Risk Management Operations Director, Suite 200, 720 Washington Avenue SE, Minneapolis, Minnesota 55414 appeared for and on behalf of the University of Minnesota Physicians. APPEARANCES: R. CHRISTOPHER BARDEN, Ph.D., J.D., Esq., GALE D. PEARSON, Esq., and STEPHEN J. RANDALL, Esq., of the law firm of Pearson, Randall & Schumacher, Suite 1025 Fifth Street Towers, 100 South Fifth Street, Minneapolis, Minnesota 55402 appeared for and on behalf of Plaintiff.

1 2 3 4 Examination: By Dr. Barden

I N D E X PAGE

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

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P R O C E E D I N G S DR. BARDEN: Well, I guess we'll go around and introduce ourselves. My name is Dr. Chris Barden, and I'm here on behalf of plaintiff Mary Weiss. MS. PEARSON: I'm Gale Pearson here on behalf of plaintiff Mary Weiss. MR. RANDALL: Stephen Randall on behalf of

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plaintiff Mary Weiss. MS. WEISS: Mary Weiss, Dan Markingson's mother. MR. GROSS: Chuck Gross on behalf of the University of Minnesota. MS. AHMANN: Bridget Ahmann on behalf of AstraZeneca. MS. NELSON: Angela Nelson on behalf of Dr. Schulz, Dr. Olson, and the University of Minnesota Physicians. MR. HUTCHINSON: David Hutchinson for the University of Minnesota. MS. FLYNN: Ruth Flynn, University of Minnesota Physicians. MR. ALSOP: David Alsop on behalf of Dr. Schulz and Dr. Olson. THE WITNESS: My name is Dr. Charles Schulz. I'm head of the psychiatry at the University of 5

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Minnesota. DR. BARDEN: Would you like to swear the witness. CHARLES SCHULZ, M.D., having been duly sworn, was examined and testified as follows: EXAMINATION BY DR. BARDEN: Q A Good morning, Dr. Schulz. Good morning.

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Q A Q A Q A Q A Q A Q A Q A

Have you ever been deposed before? Yes, I have. How many times? I can't recollect for sure. I would say maybe ten times. Have you ever been sued before? Yes, I have. How many times? I recollect four times in my career. And can you tell me the dates of those suits? I can give you an approximation of those -Great. Of those suits. That's fair. I was part of a suit brought around 1982 while I was on the faculty at the Medical College of Virginia, and I was 6

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sued in about 1983 also while I was on the faculty there. I was sued in I think about 1986 and in 1999. Is the 1999 suit when you were at Minnesota or -No. I was -- well, I had arrived in Minnesota in July of 1999, but the suit related to a case while I was at Case Western Reserve University. Can you tell me the nature of the lawsuits? Yes, I can. The first lawsuit, I was on the faculty as an inpatient attending psychiatrist at the Medical College of Virginia on a locked ward. I was taking care of a young man referred because he had not been responding -- he had the diagnosis of schizophrenia and his parents indicated he'd not been responding to

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treatment. He was referred to our hospital, where he underwent treatment for about a month and began to make some improvement. I was still a consulting of the NIH and went up to Washington from Virginia. The patient remained in the hospital, and I think on a Friday, a couple days after I left, and there had been a covering psychiatrist as an attending, the patient was on what was at that hospital known as a buddy pass, where people can go out and walk around the hospital with another one of the patients. He and this other patient went up to a porch on the top floor of the hospital, and unfortunately the buddy of my patient left my patient there, rather 7

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than staying with him, and my patient stacked up some chairs and jumped off the top of the building. Okay, so that was a suicide case. That was a suicide case. What was the outcome of that case? Well, the outcome was that the hospital was sued, I was an employee of the hospital, and there was the allegation that the porch was not safe, that it should have had a cover, not just a fence, and so the case was settled between the plaintiffs, the hospital, and me. Okay. What was the name of the case? I believe the patient's name was Krittenbrink. Can you spell that for me, please? Again, I can approximate it, I think. Sure. K-r-i-t-t-e-n-b-r-i-n-k.

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Q A

Okay, and then the second lawsuit? The second case was a young man referred to the chair of our department at the Medical College of Virginia. The chair worked with the patient for awhile. Patient had the diagnosis of schizophrenia, and because I had had training at the National Institutes of Mental Health on the schizophrenia ward, the chair asked if he could transfer the patient to my team. We treated the patient with antipsychotic medications with little result. Then 8

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he was given an augmenting medication, propranolol, and improved substantially and was released from the hospital and went to day treatment. Unfortunately, a week after his discharge, he was in the shower, and appears to have fainted while he was in the shower and, very unfortunately, passed away. There was no evidence that this was a suicide, but I was sued, and that suit was settled. Okay, so that was a wrongful death case. That's correct. Involving a schizophrenic patient. Correct. And the first one was a suicide case involving a schizophrenic patient. That's correct. How about the third lawsuit? The third lawsuit was of a woman whose father was concerned about her lack of response. She had, I think, was in her mid-30s, and had been poorly responsive and in

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and out of state hospitals for approximately ten to 12 years, and she was brought to Medical College of Virginia. She was treated with antipsychotics without benefit, and the augmenting medication clozapine was given, and the patient made some improvement, but did not recover, and was transferred to the state hospital in our 9

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vicinity. A few weeks after, maybe six weeks after the patient had been transferred, she developed bone marrow depression, and despite a lot of extensive medical treatment at the Medical College of Virginia, she died of infection. Okay. Was she a schizophrenic also? She was a schizophrenic, or schizoaffective person. And the outcome of that suit? That was settled. All right, and then you mentioned a fourth suit. Uh-huh. In the spring of 1999, a woman called to ask if her son could participate in a brain imaging research project with us, and he was evaluated, was not able to participate in the study because of a past history of substance abuse, or close enough to the brain imaging, and continued care with his doctor. The patient's mother called and said things were not going well with him and that her son felt he wasn't making progress with his psychiatrist. So they called urgently on a Monday, and I saw them maybe the next day after hours, like at about 5:00 o'clock, to see what I could do; and after an hour session of discussion, the case, etc., the patient, his

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mother said it would really, really be nice if you could work with our son. And I said, well, then, you know, I would be, I would be willing to do that. Examined him, 10

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whether he was suicidal, whether he was feeling safe, etc., and was assured he was going home to have dinner with his family, etc. Unfortunately, what happened to him was that he went home, he was a college student at the time, had dinner with his family, and then said I'd like to go over to my apartment, you know, at Case Western. Went to his apartment and jumped out the window. Was he a schizophrenic also? He was a schizophrenic person also. You mentioned the name of the first suit was the Krittenbrink? Correct. How about the second? I believe that case was Thomas Putnam, P-u-t-n-a-m. And the third case? I believe her name was Brenda White. And the fourth case? I'm sorry, I don't remember his name right off. And the fourth case settled also? Well, the fourth case was tried, and I was acquitted. Then the case was appealed, and the appellate court said that I had testified and been qualified as an expert during the trial, but because I had not been practicing a certain number of hours, my expert testimony wouldn't

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count. So they directed the case back to the court, and we settled for court costs, rather than retrying the case. Who was the lawyer in the fourth case? Just looking for either the name of the plaintiff or -Yeah, I'm sorry, I don't remember the attorney's name. It was eight years ago. And you came to Minnesota in '99? I came to Minnesota in July of '99. You mentioned you testified about ten times. Uh-huh. I imagine you did in all four of these cases. That's correct. What were the other six? Well, I have on occasion done expert witnessing or consultation. I worked one case with the State of Pennsylvania when I worked at the University of Pittsburgh, providing assessment of a man who was in prison. He had murdered his wife. He had suffered from schizophrenia. And then I've worked on about three other cases involving post traumatic stress disorder in the workplace. Okay. Can you give me the names of those? I just -- I don't have the names of those where I served 12

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as expert witness.

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Q

Do you have access to those? You do have a list of those?

A

I don't have a list of those, but if it were something that you need, I would work with Mr. Alsop and we could track down the attorneys I worked with and get those cases.

Q A Q

Great, thank you, that would be -I mean, I'd certainly do my best. That would be very helpful. Thank you. So you've only testified -- let me ask you this: Have you ever testified for the plaintiff in a malpractice case?

A

I'm trying to think. I do not believe I've testified for a plaintiff in a malpractice case.

Q

Have you ever testified for the defendant in a malpractice case?

A Q

Yes, I have. And you could -- you would be able to find out when and where that was?

A

That was about 25 years ago. So I would do my best, is all I can say.

Q

Have you testified as an expert witness in the last ten years?

A

I have testified as an expert witness I believe in one case since I've been here in Minnesota in the last eight 13

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years. That's the only one I recall in the last eight years. And where was that case, do you recall? That was a case of a psychiatrist who worked in the

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Chicagoland area, and the patient was a young man with schizophrenia, and he was living at home, and he was having some difficulties in the home, as I recall. I don't want to overspeculate on him. But in any case, what ended up happening is he ran out of his house, ran down the block, climbed a tree, and fell out of the tree, and hurt his back, a back, broke his back. And so I testified for the defense in that case. That's the only case I remember working as an expert for the defense in a malpractice suit -Okay. -- since I've been here. Have the other cases involved post -Post traumatic stress disorder. -- traumatic stress disorder. All right. Since you have this experience, you probably don't need this, but I'll just run through the list of things, the rules that we need to follow. I'm supposed to ask questions in a clear and intelligible manner; and if not, you'll let me know and I'll reask it. Fair enough? Fair enough. 14

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Q

If you ever need to take a break, we can do that whenever you'd like, but only after you've finished answering a question. Fair enough?

A Q

Uh-huh. Your lawyer will make legal objections from time to time. You need to make sure that he has the time to do that clearly on the record, and then you can answer. Fair

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enough? That sounds okay. I have talked to my attorney, and he's indicated that -MR. ALSOP: Just listen to the question. We talked. BY DR. BARDEN: Q We can't both talk at once. It makes it very hard for the reporter. I understand. And we also can't speak too rapidly, so we'll work on that. Fair enough? Okay. Okay. Now, we're both going to be very careful not to mention the names of any patients other than Dan, right? Fine. And I'm also not going to ask you for any discussions you've had with your lawyers. So even if it seems like I'm asking you for the name of a patient or some 15

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discussion you've had with your lawyers, I'm really not. I don't want that information. Fair enough? Fair. What have you done to prepare for the deposition? I've had three meetings with my attorney, Mr. Alsop. I have reviewed some materials that he's prepared for me. I think that's about it. Have you read the deposition of Dr. Olson? No, I have not. Have you read the expert witness report from Dr. Harrison

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Pope? I read a document by Dr. Pope regarding my participation or my role in this case. Okay. Have you read the expert witness affidavit from Dr. Hudson? As it relates to me, yes. Do you know Dr. Pope or Dr. Hudson? I know of their work, and I've seen Dr. Hudson at meetings. Okay. What's the -- in your field, what is the reputation of Dr. Hudson and Dr. Harrison Pope? MR. ALSOP: I'll object on the basis of foundation. If you know, go ahead. THE WITNESS: My area of work is relatively specialized into schizophrenia, psychosis, other severe 16

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illnesses; and my understanding of the reputation of Dr. Hudson, he works in the area of eating disorders and other illnesses, and I think he has very good academic reputation. Dr. Pope has been writing and investigating in the areas I treat, to my knowledge, for the last 30 years, publishes in respected journals, and is a highly-regarded academician. BY DR. BARDEN: Q Have you ever spoken to Dr. Olson about this particular case? Not since the meeting I had with him following the letter I received from Mrs. Weiss, not since the lawsuit was

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filed. What was the nature of the discussion you had with Dr. Olson at that time? I received a letter from Ms. Weiss in which she expressed concerns about her son's participation in the CAFE study. I wanted to make sure that these concerns were made known to Dr. Olson, and I had a chance to talk with Dr. Olson and one of the project coordinators, Ms. Kenney. So I had the letter available, but asked the two of them to come to my office and review the letter, hear their thoughts and concerns on what was going on with the patient, and our meeting lasted for approximately an 17

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hour. Then I drafted a letter of response to Mrs. Weiss. I gave the draft of the letter to Dr. Olson so he could review it, make sure we were all on the same page, and he knew what I was going to be sending back to her, and I mailed the letter back to Mrs. Weiss. And I did not have an opportunity to talk with Dr. Olson about the case after that time. How many letters did you receive from Mrs. Weiss? Well, I have one, and I realize there is some -- that Mrs. Weiss has indicated there were more letters, but I received a letter, I think in April. MR. HUTCHINSON: Could I interrupt? Is it Weiss or Weiss? It's Weiss, isn't it? DR. BARDEN: It's Weiss. MR. HUTCHINSON: It's Mrs. Weiss.

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THE WITNESS: I apologize, Mrs. Weiss.

So to the best of your knowledge, you only remember receiving one letter? That's correct, to the best of my knowledge, right. And how many letters did Dr. Olson receive, do you know? I don't know. During your hour-long discussion with Dr. Olson about this case after Dan's death, what did you discuss in that 18

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one-hour meeting? MR. ALSOP: That's a misstatement. This hour-long meeting was before his death. It's the meeting about the letter. DR. BARDEN: But it was the meeting. Thank you. THE WITNESS: Well, I don't have the letters available, but it was, I would say mid-April. BY DR. BARDEN: Q A Was there documentation made of this meeting? Other than the draft of the letter that I mailed back to Mrs. Weiss in response to her letter, describing what my thoughts were and my attempt to address her points, that was the only documentation made. Okay, so you had a one-hour meeting with Dr. Olson. And -And with Ms. Kenney. Uh-huh. About patient care of Dan Markingson, but there was no

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documentation made of this meeting, other than this letter. Is that your testimony? Well, the person was in a research study and -MR. ALSOP: Well, Doctor, the question is, are there any other documentation you're aware of or not. Do you know? 19

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THE WITNESS: There is no other documentation made. BY DR. BARDEN: Q Are you aware that Dr. Olson has testified that he was also Dan's treating physician throughout this entire time? I haven't seen his deposition. I don't know what he said about it. As the coinvestigator on the CAFE study, were you aware that Dr. Olson was Dan's treating psychiatrist and his only treating physician up until the day of his death? No. So this is the first time that you've learned of that. I have -- I've been made aware of that after the lawsuit has been filed. Okay, and you've read Dr. Pope and Dr. Hudson's concerns about having the treating, the only treating physician and the only treating psychiatrist, also being the PI on the study and also being the study psychiatrist for Dan, and him filling all of those roles for Dan and their expressing concern about that. You've read that, correct?

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A Q

Yes, I have. Do you share their concerns about those multiple roles for Dr. Olson? 20

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A Q A Q

No. You don't. I don't. Can you point to me any peer review journal articles or references that would indicate that Dr. Olson's behavior was acceptable, that is, being the only treating physician, the only treating psychiatrist, the PI, and the study physician for Dan? MR. ALSOP: It's vague and ambiguous, but go ahead. THE WITNESS: No. Yeah, I'm not aware of a peer review article that discusses that.

BY DR. BARDEN: Q Are you aware of any publications of any kind that would, that discuss that? A Q No. Have you yourself performed those multiple functions with your patients that you've treated? MR. ALSOP: That's irrelevant, but go ahead. THE WITNESS: Well, I have not been the principal investigator of a study for quite some time, maybe one or two studies, but in the past, maybe ten, 12, 15 years ago, I've been principal investigator of a study and the person who also was the only doctor for a patient in the study.

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

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A

That's correct.

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Q A

Okay. And so I will go over to our ward, meet the resident med student. We will see anywhere from eight to ten patients. It provides an opportunity for teaching, supervision, and discussion, but I'm the attending physician for those patients during that week I'm the attending.

Q A Q

Just for two to four weeks a year. Right. So for the rest of the year, you're not really seeing patients?

A Q A

Well, I'm sorry, I hadn't finished. Okay. But I appreciate that. So I also see people in the outpatient clinic, and I have maybe six or seven patients I work with regularly on an outpatient basis, and I'm trying to think how to quantify this. Spend anywhere from two to four hours a week in the outpatient clinic, sometimes more, sometimes less.

Q

So the number of hours over the course of a year per week that you spend in patient care is quite minimal.

A

Well, I've -- compared to what? I think compared to other people at the University, that's a pretty good clinical load for a department chair, and I think for a 23

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person, compared to a person in full-time practice, it's a small number. What percentage of your time are you seeing actual patients?

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A

I think I just described. I go to the wards two to four weeks a year, and on the wards four weeks since January, and I see outpatients in our clinic anywhere from one to two to four hours a week.

Q A

Okay, so it's less than ten percent of your time. Well, I think I've given you the actual amount of time I've spent.

Q

But in terms of a percentage of your time, what would you say, per patient, actual patient care where you're the physician in charge of that patient, not where you're supervising or you're watching other people treat?

A

No, I understand. I think I try to understand what a percentage is, is, you know, how much time I spend working in a week. A 40-hour week, I would say I probably spend somewhere between five and ten percent of my time in direct patient care.

Q A Q A Q

But you work a lot more than 40 hours a week, don't you? I do. So it would be less than ten percent, certainly. I think I said five to ten percent. Okay. Have you spoken to any representatives of the 24

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AstraZeneca firm about this case? No. You've had no conversations with anyone from AstraZeneca at all about this case. No. Have you talked to any other -- have you talked to anyone else, outside of your attorneys, of course, about this

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case, including medical colleagues? Uh-huh. Pardon? Uh-huh. I've talked to one person. I was on the phone with a colleague of mine, she and I are working on some manuscripts together. She is on full-time faculty at McLean Hospital. And at the end of the conversation, I let her know that two of her fellow faculty people had rendered the, their expert opinions, especially the part about the chair's duties to monitor trials, and asked her, is this how it goes at McLean Hospital. So I did discuss it with that faculty person. What was her name? Dr. Mary Zanarini. Mary Zanarini. Uh-huh. When did that conversation take place? Probably in the beginning of June. 25

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Q A Q A

June of this year. That's correct. So just a few weeks ago. Correct, after I had received the expert opinions of Drs. Pope and Hudson.

Q A Q

Okay. Have you talked to anyone else? Nope. All right. I'll show you what we're going to mark as Exhibit A. (Schulz Deposition Exhibit A marked for

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identification.)

Could you identify that for me. Okay. This is my curriculum vitae dated February 17, 2004. Okay, and is that your signature there? Yes, it is. It is. Okay. And you signed it 5-19-04, which gives us the date of the most recent version, correct? I don't believe so. I think the signature there for 5-19-04 is the time that this was signed for some reason or another, either participating in the study or something like that. Okay. Have you done an update of your vitae since 2004? Yes. 26

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Q A

And could we get a copy of that? I'd be happy to work with you on that. MR. ALSOP: You have a copy. MS. PEARSON: We just got one this morning. DR. BARDEN: Oh, we got one this morning. MS. AHMANN: We have it. MR. ALSOP: In the answers to interrogatories you got this morning. This document was served some time ago. MS. PEARSON: We received some time ago. DR. BARDEN: Why don't we mark this. (Schulz Deposition Exhibit B marked for identification.)

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BY DR. BARDEN: Q A Q You went to medical school at UCLA, correct? Yes, I did. Now, let me ask you a few questions. In 1988-89, you were at the National Institute of Mental Health in Rockville. Is that right? A Q That's correct. What, if any, financial relationships with drug companies did you have during that timeframe? A I think at that time I, on occasion, would give a lecture that was sponsored by a drug company, but I had no consulting relationship or any other relationship. 27

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Q

How many drug companies -- during the time Dan Markingson was in your research study -- and let me back up just a minute. You were a coinvestigator on the CAFE study, correct?

A Q

That's correct. And you were listed as a ten percent, I believe, on that study?

A Q

I don't recall. Would that be consistent with what you typically do in research studies, you're a consultant, where you help out with training or supervision or something like that? MR. ALSOP: Object as speculative and vague. Go ahead, you can answer. THE WITNESS: It's hard for me to say what I usually do, but in this case, what I remember planning on doing was being a coinvestigator to be available if a

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backup rater might have been needed or if Dr. Olson had any questions that he wanted to chat with me about about how the study went, and I don't recall exactly what the amount of time I put down on my effort certification for the study was. BY DR. BARDEN: Q A Do you have records that show that? I believe we should, at the University, have records of how much time we spend allocated to each study. 28

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Q A Q

How much funding did you receive from CAFE study? I don't believe I received any. So you were listed as ten percent, but you don't recall receiving any funding.

A

I think I said I don't recall how much time I was listed on effort, but I don't believe I received any money from the study towards my compensation.

Q A Q

But you were listed as a coinvestigator, correct? That's correct, I was. And what are your duties and responsibilities as a coinvestigator on the CAFE study?

A

I think I just mentioned that I was available if a backup rater was needed, and to be available to Dr. Olson to discuss any issues that might come up with the study, and my -- that was what my role in the study was.

Q

Are there any other duties that you have as a coinvestigator on a funded study, other than the ones you've discussed so far?

A

I think at the University of Minnesota, the other duty

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would be to, if the principal investigator were not available or if the investigator moved and the study stayed at the University of Minnesota, to be available to substitute as the principal investigator for the study until it was done. What, if any, duties do you have as a coinvestigator to 29

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ensure that informed consent is properly obtained? I have not participated in verifying informed consent or obtaining informed consent as a coinvestigator in studies at the University of Minnesota. DR. BARDEN: Objection, move to strike as nonresponsive. BY DR. BARDEN: Q What, if any, duties do you have as a coinvestigator with regard to obtaining proper informed consent? I do not have any duties as a coinvestigator regarding informed consent. What, if any, duties do you have as a coinvestigator to ensure that the rights of research subjects are protected? MR. ALSOP: Object as vague, but go ahead. THE WITNESS: I don't have any -- I'm not aware that I have -- I do not have any specific duties. BY DR. BARDEN: Q In your resume, you list a number of research publications, correct? Yes. Have you ever published anything in any peer review

23 24 25 A

journal with regard to the rights of research subjects? If I could ask a clarification of the question. I have written about informed consent. I don't know whether it 30

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

31

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

1

Q

What specific -- have you had any continuing medical

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education courses in the ethical duties physicians owe to their patients? I don't recall, no. Pardon? I don't recall that I have. You are required in the State of Minnesota to take continuing medical education, correct? That's correct. And you're also required to keep a list of the courses that you take. Is that correct? That's correct. Now, that list is not in the vitae, correct? That's correct. Do you have access to that list? Yes, I do. Where would that list be? That would be in my office, and to just answer the question further, what I do is keep the certificates of the CME activities I participate in. Would you be able to get us a copy of those? Yes. Thank you. So in your training, whatever training you've had in biomedical ethics of the duties that physicians owe to their patients, have you never seen the term 33

1 2 3 4 A

fiduciary duty? Well, I can't say whether I've heard it or not. I was just hoping you could provide some further definition so I could do my best to answer the question.

5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Q

As the chairman of psychiatry at the University of Minnesota Medical School, as you sit there now, what is your understanding, and I'm not asking you for any legal term at all, I'm asking you for the rights used in medicine, what is your understanding as you sit there now of the term a physician's fiduciary duty to patients? MR. ALSOP: Object as vague and ambiguous. Again, go ahead, Doctor, if you can answer. THE WITNESS: You know, I would only be speculating in trying to answer your question. I just -I don't know.

BY DR. BARDEN: Q Do you think it's important for a chairman of a department at the University of Minnesota Medical School to be knowledgeable about the rights of medical patients? A Q Yes, I do. Do you think it's appropriate for the chairman of a department at the University of Minnesota Medical School to be aware of basic terminology in biomedical ethics? MR. ALSOP: Object as vague. Go ahead. THE WITNESS: Could you restate the 34

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question? Because I'm -- I'm sorry. MR. ALSOP: Go ahead. BY DR. BARDEN: Q Do you think it's important for a chairman of a medical department at the University of Minnesota Medical School to understand basic terms in biomedical ethics? Yes, I do.

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Q

What training have you had with regard to obtaining proper informed consent?

A

I've had training over a number of years. I think the beginning of my training in informed consent occurred when I was a clinical associate at the National Institute of Mental Health, and the section chief, Dr. van Kammen, worked with all of the clinical associates about the issues of going through informed consent and also making an assessment of the ability of a person to consent. After that time, I've been involved in studies sponsored by industry and their startup meetings, and they provide substantial training about the informed consent process when they have their startup meetings. And then at the University of Minnesota, there are required courses in responsible conduct of research, and I've attended those.

Q

Now, throughout the course of the day, I'm never going to ask you for a legal opinion on anything. Fair enough? 35

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A Q

Sounds fine. But there are terms and concepts that are used in medicine that are also used in law, correct? MR. HUTCHINSON: Objection, lack of foundational. MR. ALSOP: I'll join. THE WITNESS: I would guess so.

BY DR. BARDEN: Q Let me give you an example. Informed consent, that's a term that's used in medicine, isn't it?

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A Q

Yes, it is. It's also used in law. But if I ask you for your opinion or for information you know about a term informed consent, I just want to clarify, I'm only asking you for your medical knowledge. I'm not going to ask you how it's used in the legal world. Is that okay?

A Q

That's fine. But as a licensed physician in the State of Minnesota, you are required to know some legal things, aren't you? MR. ALSOP: Object to foundation.

BY DR. BARDEN: Q Such as the rights of patients with regard to informed consent. Is that right? MR. HUTCHINSON: That sounds like are you asking him if he's required to know the legal rights, and 36

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I understand from your prior preface that you're not asking that. BY DR. BARDEN: Q I'm just going to make it clear. You're a licensed physician in the State of Minnesota, correct? That's correct. And as a licensed physician, you are required to know certain things. Isn't that right? MR. ALSOP: Object to lacking in foundation. Go ahead. THE WITNESS: I'll say yes. BY DR. BARDEN: Q Okay. As a licensed physician practicing in the State of

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Minnesota, what is required of a physician in terms of obtaining informed consent, what information are you required to obtain from the patient and give to a patient? The way I'd like -MR. HUTCHINSON: Again, you're not asking for the legal requirements, I understand. DR. BARDEN: I think the question is clear as it stands, uh-huh. MR. HUTCHINSON: No, I disagree, but go ahead, Doctor. THE WITNESS: I think the best way that I 37

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know how to answer the question is to describe what I do at my work with the patients I work with. When patients come into either our clinic or into our hospital, they sign a form consenting to participate in research. Then when I see the patient, I talk with the patient about my assessment, and then I discuss with them a treatment plan and treatment alternatives. So, for example, if I were meeting with a person who had schizophrenia and I thought that there was a medicine, such as risperidone, that might be best for them, I would also discuss with them there might be some alternative medicines, I would describe the side effects, and then I would talk with them about what they would like to do, and then I would proceed with the plan. BY DR. BARDEN: Q Okay. Would you do anything else, other than what you've

17 18 19 20 21 22 23 24 25 Q A

described? I think the only other thing I know about our current practice is on our inpatient service, when a person is -when an antipsychotic medication is recommended, there is a separate form in our hospital that we go through the risks of antipsychotic medication treatment, and the patient signs that. And do you know if that form was ever obtained from Dan Markingson? 38

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A Q A Q

I don't know. Have you reviewed the case records? No. When you had your one-hour meeting with Dr. Olson and Jean Kenney, you never looked at any of the records?

A Q

No. I just met with them. Did Dr. Olson ever inform you that he never obtained such a document from Dan Markingson?

A Q

No, he didn't. Did Dr. Olson inform you in that hour meeting that Dan Markingson was under a threat or stay of commitment when he signed the informed consent form for the CAFE study?

A

Well, you've used two terms there, one was threat of commitment, the other is a stay of commitment, and so maybe you could clarify which you'd want to talk about.

Q

Are you aware of any difference between the threat of commitment and the stay of commitment?

A

I'm aware of what a stay of commitment is in Minnesota, and I'm not aware there is a term in Minnesota threat of

20 21 22 23 24 25 Q A

commitment. Okay. What's your understanding of a stay of commitment? My understanding of it is, is that a person can, in a hypothetical example, I'm working with a patient on a ward, the person would be able to leave the hospital and be on a stay of commitment, and if things did not go in a 39

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good direction for that person, they didn't participate in their care, then they could be brought back to hospital. And what's the purpose of a stay of commitment? I think the stay of commitment is to have a mechanism to be able to keep a person in treatment. Yeah. It's to control the person, isn't it? No. MR. ALSOP: That's argumentative and a misstatement of his testimony. Wait, wait. Go ahead. THE WITNESS: Pardon me? MR. ALSOP: You can answer, Doctor. BY DR. BARDEN: Q As a physician who has worked with patients, what, if any, coercive influence would you say there is from a stay of commitment hanging over their head during their care? None. Are you aware of any peer review journal or article that would support your statement? No. Did Dr. Olson inform you that Dan Markingson was under a

23 24 25 A

stay of commitment during your hour-long meeting with him? No, he didn't, to the best of my recollection. 40

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Q

Did Dr. Olson ever inform you that he was, A, going to recommend that the court recommit or restay the commitment for Dan Markingson, because he considered him a danger to himself or others?

A Q

No. And at the same time, he was not going to reconsent him to the study? Did he tell you that?

A

I'm sorry. There were a lot of parts to that. I didn't quite get it.

Q

Yeah. Several weeks before Dan died, were you aware that Dr. Olson was going to petition the court to recommit Dan Markingson at the same time he was going to not reconsent him for the study?

A

I'm sorry, I'm still not quite following, especially the not knowing the dates or other things like that.

Q

Would you be concerned if a psychiatrist under your supervision was telling a court that a person was incompetent, and was telling the research agencies that a person was competent at the same time? Would you be concerned about that? MR. ALSOP: Object as vague and ambiguous. Go ahead, Doctor. THE WITNESS: Are you asking that in a hypothetical sense?

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

1

of foundation.

2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A BY DR. BARDEN: Q

MS. AHMANN: Join. THE WITNESS: You know, my best answer is I would want to know more. I think in the, my understanding, in the State of Minnesota, a committed person still, if felt to understand a research study, may participate in a research study. So I do understand your question, and it would cause me concern if I were to learn about the scenario you described, but then there would be other circumstances or I'd want to know more about the story of how the person could stay in the study and be a committed patient. BY DR. BARDEN: Q Are there special rules and principles at the University of Minnesota with regard to research subjects who are decisionally impaired? MR. ALSOP: Object on the basis of foundation. Go ahead. MR. HUTCHINSON: Join.

Well, let me deal with your lawyer's objection. Do you know what the term decisionally impaired means? Yes, because I also collaborate with people who work in research with, clinical research with people with mild 43

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cognitive impairment or Alzheimer's disease, and so there are patients there who have poor memory, and so they are -- I don't know whether the technical term is decisionally impaired or vulnerable, but I know that

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there are needs to make sure that such a patient is, Alzheimer's patient is, say the family would be involved, etc., before a person would be involved in the study. How about psychotic patients? Psychotic patients, my understanding is that there is an obligation to understand whether the person understands the study they are participating in, can answer questions about what the study is about, what some of the side effects of the medication are, what the point of the study is, etc. Okay. Going back to your lawyer's objection again, are you aware of the IRB rules and requirements and guidelines for the University of Minnesota? I think I'm -- I'm aware of those, sure. Now, given that you're aware of the term decisionally impaired and given that you're aware of the term, of the guidelines of IRB, what are, as you sit there now, what are the guidelines for the IRB at the University of Minnesota with regard to a decisionally impaired subject? Well, I think, first of all, there is a decision as an investigator goes through the IRB process, whether or not 44

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the subjects who are being involved in the protocol are vulnerable, and if that is determined that they may be, that there may be subjects there, then there needs to be a plan about how to obtain consent. So if we're talking generally, then, for example, if we had a person under the age of 18, we would want to obtain the consent of the parents and the assent

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of the subject. Anything else? No. Is there any other system in place for vulnerable subjects, any other steps that are supposed to be taken? My understanding of the rules about vulnerable, possibly vulnerable people, is that the investigator is to work with the IRB to make a plan that is specific to his protocol. If a psychiatrist, treating psychiatrist, and a treatment team and an outside evaluator had all determined that a patient lacked capacity, was grossly psychotic, was not aware that he was mentally ill, and felt that he didn't need treatment, and petitioned a court for commitment, would that person be a vulnerable research subject within the guidelines of the IRB at the University of Minnesota? Without knowing more about the specific case, I can't answer that. 45

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Q A Q

Based on what I've told you so far, you don't -Not necessarily. Okay. Would you be concerned that a patient that had had that many evaluations, finding them lacking capacity, finding them grossly psychotic, finding them not aware that they were mentally ill, and finding them not interested in treatment, would you be concerned if that patient had not been evaluated as a potential vulnerable subject? MR. ALSOP: That's repetitious, it's vague

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and ambiguous. Go ahead, Doctor. MR. HUTCHINSON: I join. Lack of foundation. THE WITNESS: I'm sorry to have to say that I'm still confused about the question, whether we're talking about this in a hypothetical sense or whether we're talking about it, about a specific circumstance, say with this person, with Dan. BY DR. BARDEN: Q A Well, right now we're talking about a hypothetical. Given the hypothetical, then I think that there may be some other information I would want to learn about the patient; and if the patient were, despite some of the aspects of the seriousness of the illness, have understanding of the research process, the research 46

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protocol, and wished to participate in it, I would not view him as necessarily incompetent to consent. But you didn't read the records for Dan Markingson, correct? Correct. And in your one-hour meeting with Dr. Olson, he didn't inform you that he and the treatment team and the outside evaluator had all found Dan Markingson, within days of when he signed the informed consent in this study, to lack capacity, to be grossly psychotic, to not think he was mentally ill at all? Dr. Olson didn't inform you of that, did he? No, he didn't.

14 15 16 17 18 19 20 21 22 23 24 25

Q

Do you have methods and procedures in place in the Department of Psychiatry to catch rogue psychiatrists? MR. ALSOP: I object as vague and ambiguous and irrelevant, but go ahead. MR. HUTCHINSON: Same. Lack of foundation. THE WITNESS: So the quality assurance processes at the University of Minnesota and the University of Minnesota Medical Center at Fairview are that on every inpatient service--and let me put a time limit on this, because in the last year, it's been changed to electronic, but that's not relevant to the timeframe we're talking about--that there are forms on 47

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

every ward, and that the staff on the ward, any staff, can write a complaint of concern about any physician's activities, and then that is sent to the administration of the hospital; and then that, after it's reviewed by the administrative staff, may be referred back to the unit to be discussed between medical director and person who was complained about, or if it was an issue of a difference of opinion about a treatment approach between say a staff nurse and a patient, that it would be discussed on the unit. Or, in rare cases, it would be referred to a University of Minnesota Medical Center quality committee. BY DR. BARDEN: Q A Q Was this system in place during the time Dan was treated? Yes. Have you -- let me go back to the rogue psychiatrist

17 18 19 20 21 22 23 24 25

question first. Have you had trouble in the past at the University of Minnesota Psychiatry Department with someone considered rogue psychiatrists? MR. ALSOP: Same objection, it's irrelevant, but go ahead. MR. HUTCHINSON: Objection, lack of foundation. MS. AHMANN: Join. THE WITNESS: I've been at the University of 48

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Minnesota for eight years, and I'm not aware of any. First of all, I have to preface my remark. I don't know what the definition of rogue psychiatrist is. BY DR. BARDEN: Q Okay. Let me give you one. A psychiatrist who's been prosecuted and found guilty of criminal activity. That would be a rogue psychiatrist, wouldn't it? MR. HUTCHINSON: Well, you're the one using the term rogue. Is that how you want to define it, counsel? BY DR. BARDEN: Q A Q Have you never heard the term rogue psychiatrist? No. Okay. Well, let me say criminals or people who violate the ethics code or people who have their licenses suspended. Is there a history of that at the University of Minnesota Psychiatry Department? MR. HUTCHINSON: Same objection. MR. ALSOP: I join, foundation, but go

20 21 22 23 24 25

ahead, Doctor. THE WITNESS: I am aware of that, of two instances prior to my coming to the University of Minnesota, where proceedings were brought against a psychiatrist, Dr. Garfinkel, and I am not -- that was well before I got here, but I am aware that charges were 49

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brought against him and that those were sustained; and I know that he is not working at the University now and works in private practice here in the Twin Cities. BY DR. BARDEN: Q Do you know what the charges were while he was a faculty member in the Department of Psychiatry? I don't. You don't. No. Were they criminal in nature, do you know that? I don't know that one way or the other. How about Dr. Abuzzahab? Have you ever heard that name? Yes, I have heard of Dr. Abuzzahab. Do you know of any unethical behavior, misconduct, license revocations, with regard to Dr. Abuzzahab? MR. ALSOP: Object on the basis of relevance. He wasn't at UM-DP, but go ahead. DR. BARDEN: Goes to show a pattern of conduct. THE WITNESS: When I arrived here at the Department of Psychiatry, the department administrator informed me that Dr. Abuzzahab, who was in private

23 24 25

practice and not a member of the Department of Psychiatry at the time, although I think he may have been on volunteer, so-called adjunct or a volunteer faculty, had 50

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A Q Q A A

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

51

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

1

A

I haven't looked at that lately, but I think I've said he

2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Q

is on our adjunct faculty. Okay, and since he's on your adjunct faculty, if he can claim this University of Minnesota label, what steps, if any, did you take to investigate the reasons why his license was suspended? MR. ALSOP: Object on the basis of relevancy, but go ahead, Doctor. MR. HUTCHINSON: Join. THE WITNESS: You know, I think -- I realize there are rules about when we can take a break and not take a break. Can we take a break now or -MR. ALSOP: First, you can answer that question first. BY DR. BARDEN: Q A Q A Q A Q You can take a break whenever you like. Okay. But only after you finish answering a pending question. I understand. Could you repeat the question for me? Yeah. You're the chairman of psychiatry, right? I am, that's correct. You do have a duty to get unethical people or people who are reckless or dangerous, to keep them off your faculty, correct? MR. HUTCHINSON: Well, now we're going 53

1 2 3 4

beyond -- he wanted to take the break, and now we're asking additional questions. MR. ALSOP: Just answer the question that he asked.

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THE WITNESS: I'm sorry, I don't know what that question was. BY DR. BARDEN: Q What steps, if any, did you take to investigate why Dr. Abuzzahab had his license suspended? MR. ALSOP: Object on the basis of relevancy. Go ahead and answer, Doctor. THE WITNESS: The steps I took were to talk to faculty who had been in the department prior to my arrival about their understanding and work with Dr. Abuzzahab. I recollect seeing material from the State regarding that his license had been suspended, and then I met with Dr. Abuzzahab. I relieved him of his position he had before I arrived, that he held, which was head of the clinical faculty committee, and replaced him with Dr. Gaylen Staylen. MR. ALSOP: Okay. DR. BARDEN: I think we offered you a break. THE WITNESS: Thank you. DR. BARDEN: We'll pick this up when we come back. Five minutes, ten minutes? 54

1 2 3 4 5 6 7 BY DR. BARDEN: Q

MR. ALSOP: Five minutes is fine. (Brief recess taken.) DR. BARDEN: We're back on the record.

Dr. Schulz, a little while ago you told us about your system at the University for reporting complaints. Do you recall that?

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A

For University of Minnesota Medical Center at Fairview Hospital.

Q A Q A

Uh-huh. You seemed pretty pleased with that program. Uh-huh, I did. I am. Do you think your testimony on that issue was misleading? No. MR. ALSOP: It's argumentative. Go ahead.

BY DR. BARDEN: Q Have you in fact had trouble with your complaint system at the University of Minnesota Department of Psychiatry? MR. HUTCHINSON: When? MR. ALSOP: Vague and ambiguous. Go ahead. BY DR. BARDEN: Q During the time Dan Markingson was treated -MR. ALSOP: Same objections. BY DR. BARDEN: Q -- did you have serious problems with the way complaints were handled and filed at the Department of Psychiatry at 55

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the University of Minnesota? Not that I'm aware of. Have you ever been audited? Have I ever been audited. Has the Department of Psychiatry ever been audited? Oh, I'm sorry. Yeah, University of Minnesota provides for audits of all departments on a regular basis every seven to ten years, and we completed our audit I think about a year and-a-half ago. And they interviewed people, almost all of whom worked at

11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A Q Q A Q A Q A

the Department of Psychiatry during the time Dan Markingson was treated and was a patient and was a research subject there, correct? I'm not sure I know all that they did, and they made a report, so if I could refer -- I'd be happy to refer to the report and talk with -The University did? Yeah, the University's audit report. The University audited your department, correct? Uh-huh, that's correct. One of the things they did was to interview your employees and staff and faculty members. Isn't that correct? I believe so, yes. And the vast majority, in fact, almost all of those 56

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people, worked in your department during the time Dan Markingson was a research subject and a patient there. Isn't that correct? MR. ALSOP: Object on the basis of foundation, it's also vague. Go ahead, Doctor. MR. HUTCHINSON: Join. THE WITNESS: I would say that that's approximately true, that a substantial number of people that were working in the department in 2004 who participated in the audit. BY DR. BARDEN: Q I show you what we're going to mark as Exhibit C. (Schulz Deposition Exhibit C marked for

14 15 16 17 18 19 20 21 22 23 24 25 copies for -BY DR. BARDEN: Q

identification.)

If you could take a look at that and identify it for the record? MR. ALSOP: Do you have copies? MR. HUTCHINSON: Excuse me. Do you have

MR. ALSOP: Everyone. DR. BARDEN: I think I have a couple. Here's one. Yeah, I think that's all I have right now. MR. ALSOP: Why don't we -MS. PEARSON: We produced those. 57

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 second. copies.

DR. BARDEN: We're only going to look at it for about two minutes. MR. ALSOP: Why don't you wait until we get

MS. AHMANN: Is that the July 2006? MR. ALSOP: Just go off the record for a

DR. BARDEN: Going to go off the record, and stop the clock. Thank you. (Brief time off the record.) DR. BARDEN: We're now back on the record. For the record, we've just stopped for a long time to make copies of these documents. For the future, to keep this moving along, and so we can finish today, if possible, if we have produced these documents to you, we're just going to go ahead. If you want to look over

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my shoulder or the doctor's, that's fine. But we have a large number of documents, I don't know which ones we're going to use or not, because it all depends on the doctor's answers to many questions. We couldn't bring a 20-foot stack of documents to hand all out. All of these documents have already been disclosed to you, so we're just going to move forward. MR. ALSOP: These were e-mailed, I saw, this morning, apparently. I hadn't downloaded them yet, and 58

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to say they were produced and we can have copies is not an accurate statement. DR. BARDEN: Well, we're just going to move forward, because it's easier. The time to take to do this is simply too long. BY DR. BARDEN: Q Doctor, could you identify what's been marked as Exhibit C for the record, please. This is an audit report of the Department of Psychiatry at the University of Minnesota. Okay, and have you read this document before? Yes, I have. And you've written about it, haven't you, you've written letters back and forth to these folks who did the audit? I have talked with them and I have, pretty sure I have given some written communication back and forth, yes. Okay, so you were certainly aware of this audit of your department, correct? Yes.

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Q

How many times has your department been audited in the last four years?

A Q A Q

Once. It's been audited once in the last eight years. So then you're certainly quite aware of this audit? Yes. Okay, so during the time you were telling us about the 59

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wonderful complaint procedures that you have, you were aware of page 11 of this audit report that indicates -in fact, look at the top of page 11. It says, quote, "Additionally, the following issue received a --" I'm sorry, let me -Page 11 at the top. Just want to make sure I'm with you. "The following issue received a high negative response on all three surveys. 41% of the Staff employees, 33% of the Residents, and 71% of the Faculty said they were unfamiliar with how to report violations of law or policy, including the University's confidential reporting line." Did I read that correctly, yes or no? Yes. And you had read this document before you gave us your testimony about the reporting system at the U, correct? Yes, I did. Now, we look at the top of page 11 here, where it says, "39% of the Staff did not believe that they would be protected from retaliation if they were to report a suspected violation." Did I read that correctly, at the top of page 11?

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A Q

Yes, you did. And were you aware of that when you testified here just a few minutes ago? 60

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A Q A Q

Yes, I was. Now, we were talking about Dr. Abuzzahab, correct? Yes. And Dr. Garfinkel, and you'd mentioned they'd had some difficulties, correct?

A Q

That's correct. Yeah. Didn't Dr. Garfinkel, in fact, wasn't he convicted of multiple felonies?

A Q

I don't know. I show you what we're going to mark as Exhibit No. D. I do have copies of this. MS. PEARSON: Dave, there is copies for you. MR. ALSOP: Yeah, I'm passing it out. (Schulz Deposition Exhibit D marked for identification.)

BY DR. BARDEN: Q This is a New York Times article dated June 3, 2007. The title is "After Sanctions, Doctors Get Drug Company Pay." Have you read this, Dr. Schulz? A Q Uh-huh. It begins by saying, "A decade ago the Minnesota Board of Medical Practice accused Dr. --" A Q A I'm sorry, where are you reading from? From the very first sentence. Mine says, "When Anya" is my first sentence.

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A Q A Q A Q A Q BY DR. BARDEN: Q letters?

DR. BARDEN: Okay. We're going to make this Exhibit No. E. MR. HUTCHINSON: Are we using numbers or

DR. BARDEN: We're using letters. And then we'll come back to D. (Schulz Deposition Exhibit E marked for identification.)

Okay. Do you see at the top where it says, "After Sanctions, Doctors Get Drug Company Pay?" Yes. June 3, 2007, New York Times, correct? I do. Have you read this article before? I have. Okay. Looking at the first sentence, "A decade ago the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a," quote, "'reckless, if not willful, disregard,'" unquote, "for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that." Did I read that right? Yes, you did. Okay. What percentage of physicians in Minnesota have 62

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their license suspended, do you know?

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A Q A Q

No. Do you have any idea at all? No. It is an extraordinarily rare occurrence, isn't it, Doctor? MR. ALSOP: Object as speculative, lacking in foundation. Don't speculate. He said twice he doesn't know. THE WITNESS: I don't know.

BY DR. BARDEN: Q Now, looking down farther down the page, it says, "In its disciplinary action against Dr. Abuzzahab." Have you read the state board's disciplinary action report? MR. ALSOP: You can answer that question, Doctor. THE WITNESS: No. BY DR. BARDEN: Q You didn't think that would be an important thing to do, to -- you have a person on your clinical faculty who's had a license suspended, but you did not read the state board of licensing's report on him, correct? MR. ALSOP: Object as argumentative. MR. HUTCHINSON: This is the report from 1997? 63

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BY DR. BARDEN: Q The report of the state board of medical licensing that suspended Dr. Abuzzahab's license. Have you read that report?

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A

No. Oh, but, and the date of that was? You asked me if I read the report. When was that?

Q

Correct. And I get to ask the questions, fortunately. MR. HUTCHINSON: Well, the first line says ten years ago. A decade ago. DR. BARDEN: Yes, that is correct. MR. HUTCHINSON: Which would be 1997. That's how I understand it. DR. BARDEN: I believe that is the date.

BY DR. BARDEN: Q It says further down, "Dr. Abuzzahab failed to appreciate the risks of taking Patient No. 46 off Clozaril, failed to respond appropriately to the patient's rapid deterioration and virtually ignored this patient's suicidality." Do you see that? A Q Yes, I do. That's remarkably similar to the accusations against Dr. Olson in this case, right? Isn't that correct? MR. ALSOP: Object as argumentative, a misstatement.

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BY DR. BARDEN: Q He failed to respond appropriately to the patient's deterioration and virtually ignored the patient's suicidality. Aren't those the allegations in this -MR. ALSOP: Object as argumentative. MR. HUTCHINSON: I'll join. MR. ALSOP: If you know, Doctor, go ahead.

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THE WITNESS: Just to be clear, the question, you're asking me about the allegations against Dr. Olson, compared to these findings by the board ten years ago. BY DR. BARDEN: Q A Q Right. We're in the early process -Uh-huh. -- of this legal litigation with regard to Dr. Olson's conduct, correct? Right, right. Yeah, but you've read Dr. Hudson and Dr. Pope's opinions, right? Uh-huh. Isn't this true, that -What I said is I read their opinions as it related to me. I did not read their opinions as it related to Dr. Olson. But in their, in their opinions which related to you, they certainly clearly stated that it was their opinion 65

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Dr. Olson failed to respond to Dan's deterioration and virtually ignored his suicidality, correct? I can't recall. How long ago did you read those? I believe they arrived in the end of May. "The Times's examination of Minnesota's trove of records on drug company payments to doctors found that from '97 to 2005, at least 103 doctors who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers."

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A Q

Where is that? "The median payment over that period was $1,250; the largest was $479,000." And you've read this before, correct?

A Q

Where are you reading from? Page 2, at the top. Now, Doctor, Dr. Schulz, during the time you've been at Minnesota from '99 to the present -let's do it this way: From '99 through the time that Dan Markingson was a subject in the CAFE study, that is, through 2004, how much money have you received from drug firms?

A

I -MR. ALSOP: Object to --

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BY DR. BARDEN: Q I'm talking from all sources. MR. ALSOP: It's irrelevant and vague, but go ahead, Doctor. It's also lacking in foundation. THE WITNESS: I can only make an estimate. I believe that some years, from all sources, or putting together work for different companies, some years -- I want to make one more qualification. If I am asked to give a lecture for a drug company, I will receive money for the honorarium to give the talk, and then I will receive money for my expenses to fly to the site and stay in a hotel, eat dinner. BY DR. BARDEN:

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Q

I'm interested in all of that, all of those files, all totalled.

A

I can't estimate all of that, but I would say that some years I have made $20,000 and some years I may have made $50,000 or $60,000, for professional services and expenses.

Q

So over a five-year period, you'd estimate that of, what, a quarter million dollars, more, less?

A

It has to be less, if some years are 20,000 and other years are higher. Maybe 150,000, 180,000 dollars, in total.

Q

And that's from all drug companies from all sources, and 67

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that includes being an investigator on research studies, speaker, honorarium, consultant, travel expenses reimbursed, and everything else, correct? No. I appreciate your clarifying that. What I was responding to was money I had received to give a lecture or to consult, but I have been the principal investigator of two studies recently by Eli Lilly. MR. ALSOP: I think he asked up until 2004. THE WITNESS: Oh, okay. I think the point that I'm trying to make is to clarify my response to you about money received, and that my answer to you was based on describing to you money I'd received to give a lecture or for the expenses to get back and forth from the lecture. I have also been the medical director of some of the department's CME meetings, and we have

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received unrestricted educational support from pharmaceutical companies to support these meetings, and I'm aware on these databases that you have been talking about that on occasion they will list that as money I have received, when it's essentially gone straight to the CME office. DR. BARDEN: Objection, move to strike those parts that are nonresponsive.

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BY DR. BARDEN: Q Looking for the dollar amount from any drug company, any time, any kind of funding of any type sourcing from any pharmaceutical company and ending up at you, and let's start from 1999 through 2004, looking for a dollar amount. And we don't really, we don't need to estimate this eventually, because you do file income taxes. Is that correct, Doctor? A Q A Q That's correct. And you do report this as income, correct? Uh-huh. And so, for example, if you're reimbursed for a trip to Hawaii for a week, you do report that travel ticket as income, do you not? A I'm not -- the question was sort of long. I'm not quite understanding the question. Q Okay. If you receive a ticket to Hawaii from a drug company to do a talk, you do report that to the IRS as income, correct?

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A

I haven't been to Hawaii, but wherever I might get the talk, if the company sent me a check for my honoraria and for the expenses, yes, I would report that.

Q

What if they just gave you a plane ticket, do they ever do that, send --

A

Sometimes they do. 69

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Q A Q A

Do you ever report that? I don't report that. So we're looking for a dollar amount, '99 to 2004. You know, but given the parameters that you've put, and I just, I can only make the estimate that I answered before. That for speaking engagements and the expenses for those speaking engagements, my estimate is that -for the beginning of 1999 through the end of the fiscal, academic fiscal year 2004, June 2004?

Q A Q

Uh-huh. Five years? I would say maybe 180,000. $180,000. And that's in addition to whatever salaries or clinical fees you're getting. Okay.

A Q A Q A Q A Q

I don't receive clinical fees above and beyond my salary. Okay, so this is above and beyond your salary, correct? Correct. $180,000 over that five-year period? For five years. Above and beyond your salary? That's correct. Let's say all the way from medical school to today, how much money have you received from drug companies?

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MR. ALSOP: Lacking in foundation, irrelevant, but go ahead, Doctor. Also speculative. THE WITNESS: The reason I'm pausing is that 70

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

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A

Well, if you're taking my estimate of 180, adding 70 and 25, then, yes, it would be above 250,000.

Q

Okay. Do you have any concerns that accepting that much money from a drug company could impair your judgment in any way? MR. ALSOP: Objection on the basis of relevancy and foundation, but go ahead, Doctor. MS. AHMANN: And also, you said drug company. I think he testified there were several drug companies. Clarify.

BY DR. BARDEN: Q Put an S on that. Do you think receiving funding from, that level, from drug companies might impair your judgment in some way? Do you have any concerns about that? A I have concerns about it. I think it would be inappropriate to think that there could be none, and so I think it is important to be aware that if a person is working or collaborating with a pharmaceutical company, to be aware that there may be a possibility that it could influence a judgment. Q Looking again at what's been marked as Exhibit -MS. PEARSON: D. BY DR. BARDEN: Q D, I believe, "After Sanctions, Doctors Get Drug Company 72

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Pay?"

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A

Okay. Which one is that, D or E? MS. PEARSON: E.

BY DR. BARDEN: Q E, E as in Edgar. Look at page 2 of 5 at the bottom there. It says, "records most likely understate the extent of the problem because they are incomplete. And the Minnesota Board of Medical Practice disciplines --" A Q A Q I'm sorry. Where are you reading? I'm sorry. Right here (indicating). We can just -Okay. "The Minnesota Board of Medical Practice disciplines a smaller share of the state's doctors than almost any other medical board in the country, according to rankings by Public Citizen." Were you aware of that? MS. AHMANN: I'm going to object to vague. I'm not sure what you're asking him. You read a couple of sentences; they're different. BY DR. BARDEN: Q Okay. Are you aware of the fact that Minnesota disciplines a smaller percentage of the state's doctors than any other state? MR. HUTCHINSON: According to that advocacy group. MR. ALSOP: Object on the basis of 73

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foundation. He's already answered, but go ahead, if you know. THE WITNESS: My response is I'm seeing this here. I don't have another way of knowing that.

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BY DR. BARDEN: Q Do you have any reason to doubt that's accurate, by the way? Aren't there several sources that have validated that? A Q I'm not aware of any. The next line says, "Dr. David Rothman, president of the Institute of Medicine? Have you heard of the Institute of Medicine? A Q A Yes, I have. What is the Institute of Medicine? My understanding is the Institute of Medicine is an organization made up of eminent physicians, but I think psychologists and others can be members, I don't know that for sure, that is a -- the membership, I believe, includes people who have been named to the National Academy of Science, and the organization itself frequently looks at major health issues around the United States. Q A Q It's a very prestigious group, isn't it? Absolutely. And Dr. Rothman is the president of the Institute of 74

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Medicine as a profession. It's a very prestigious position, isn't it? Did that mean professor? President. Well, it says Institute of Medicine as a profession. That probably means professor, doesn't it? No, as a profession.

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A Q A Q

Okay, so that's his job. Yeah. Okay. So it says, quote, he said, quote, "'Clinical trial investigators must be culled from --"

A

I'm sorry, I was reading here. It said, "'There's no reason to think Minnesota is unique.'"

Q A Q

Yes, and -Okay. Right. "'There's no reason to think Minnesota is unique.'" Hearing about the problems in Minnesota. Isn't it true that Minnesota has a unique law requiring physicians to disclose funding from drug companies? MR. ALSOP: That's a misstatement of the law, it's argumentative also, but go ahead. Calls for legal conclusion.

BY DR. BARDEN: Q Are you aware of whether Minnesota has a law requiring 75

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physicians to disclose payments from drug companies? I am aware of a law in which pharmaceutical companies are required to send to the pharmacy board the amounts of money that companies provide to physicians, but the -that's my understanding of the law. Okay. Are you aware of any other state other than Minnesota that has such a law? My understanding is that Vermont is the other state. All right. So he says Minnesota, "'no reason to think Minnesota is unique.'" He says, quote, "'Clinical trial

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investigators,'" we're talking about a quote from Dr. David Rothman again, "'must be culled from only the finest physicians in the country,' he said, 'since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage,'" unquote. Do you agree with Dr. Rothman's statement there? MR. ALSOP: It's irrelevant, but go ahead, Doctor. THE WITNESS: I'm pausing to make sure I give a thoughtful response to your question. I'm going to answer it in subparts. The first part is that I have been involved in clinical research since I started my clinical associateship 30 years ago, and I certainly want to think 76

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that the people involved in clinical research are good doctors. The part that he says, that says, "drug makers are scraping the bottom of the ... barrel is an outrage," I can't really comment on that. I don't know whether they are or not. But I certainly do agree with Dr. Rothman that it would be really a good idea if we could have really good doctors be the ones who are running these trials. BY DR. BARDEN: Q Has Dr. Abuzzahab done any drug research during the time you've been at the University of Minnesota, to the best of your knowledge? I don't have any -- there is no mechanism for me to read

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any report one way or the other of whether he does, but I have heard that he was looking for patients to participate in a clinical trial during the last eight years. Well, on the front page of what's been marked as Exhibit E, it says, "Dr. Abuzzahab, a Minneapolis psychiatrist, is still overseeing the testing of drugs on patients and is being paid by pharmaceutical companies for the work." Okay. "At least a dozen have paid him for research or marketing since he was disciplined." Does that help? 77

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A

Yeah, I appreciate that, and it is in agreement with my saying that I was aware, prior to this article, that he was doing clinical research.

Q

If you look on page 4 of 5 of what's been marked as Exhibit E, it says, "In cases involving Dr. Abuzzahab over 15 years in the '80s and '90s, the medical board found he repeatedly prescribed narcotics and other controlled substances to addicts, renewing one patient's prescriptions six weeks after the patient was jailed and telling another that his addictive pills should be thought of as," quote, "'Hamburger Helper.' He prescribed narcotics to pregnant patients, one of whom prematurely delivered a baby who soon died," unquote. Were you aware of these kinds of activities by Dr. Abuzzahab?

A

No.

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Q

Are you aware whether the medical licensing board's report that suspended his license, are you aware of whether that's a public document or not?

A Q

I'm not aware. Do you think having a person like Dr. Abuzzahab doing drug research, and given the history with Dr. Garfinkel and given the audit report that 71 percent of your faculty didn't even know how to lodge a complaint of a violation, do you think that shows a pattern of lax 78

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management at the University of Minnesota Department of Psychiatry? MR. ALSOP: Object as irrelevant, multiple question, and misstatement of the facts regarding the drug research. You can answer. MR. HUTCHINSON: Same, and lacking in foundation. THE WITNESS: So I'd like to respond, begin my response to your question by the last point. You've shown me our University audit, and in which a survey of the faculty and staff responded to a questionnaire about how to make a complaint regarding policy of the staff in the academic department, and I just want to be clear that the mechanism that I told you about earlier is a University of Minnesota Medical Center at Fairview document that is available on all the wards and was not the scope of the University of Minnesota report. The University of Minnesota report was focused on the academic department and was asking such questions around

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issues such as filing of expense forms, etc., was not clinically focused. So that was the third part of your three-part question. If you could remind me the other two parts.

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BY DR. BARDEN: Q The question was very simple. Do you think this shows a pattern? Is there a pattern of lax management with regard to protecting patients' rights at the Department of Psychiatry, as demonstrated by the Garfinkel, Abuzzahab, 71 percent of physicians not knowing how to file complaints, and this case? A I'm sorry, I just want to make sure I understand your last statement. Seventy-one percent of who? Q A Do you recall we looked at the audit? Yeah, I do. Why don't we look at it again for a second just to make sure. Q A It's page 11. I think we were looking at page 11. MR. HUTCHINSON: Just while he's doing that, just so the record is clear, I do object to the question on the ground it lacks foundation, calls for speculation, conjecture, and is irrelevant. MR. ALSOP: I'll join in those objections. THE WITNESS: Again, talking about the third part of this, this audit, which is not addressing at all the earlier process for clinical work on our wards, it

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was concerning to me, and we have held a number of staff meetings to further make sure that our staff understands about these, and I do not think that there is, in the 80

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

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

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A

Okay. Pardon me.

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MR. ALSOP: The question was were you aware of that or not. If you're not -BY DR. BARDEN: Q A Q Were you aware of that or not? No. Before you came to Minnesota, had you had relationships with drug manufacturers at the other universities that you worked at? MS. AHMANN: Object as vague.

I'll make it more specific. Had you received money from drug manufacturers before you came to Minnesota? Yes. Were you known as someone who had good relationships with drug manufacturers before you came to Minnesota? MR. ALSOP: Object on the basis -MR. HUTCHINSON: Object as lacking in foundation as to what other people thought. MS. AHMANN: Same. MR. ALSOP: I'll join in that. You can answer, Doctor. THE WITNESS: I can? MR. ALSOP: If you know. THE WITNESS: Well, I don't know about what 83

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my reputation is, but honestly speaking, I have worked in the area of clinical trials, as I mentioned earlier, for a number of different years, and I have given lectures for a number of different companies since about 1980.

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BY DR. BARDEN: Q Were you in fact brought to Minnesota in part to improve the relationship between Minnesota psychiatrists and drug companies? A Q No. You think it's a coincidence that payments to Minnesota psychiatrists rose sixfold during the years that you've been here? MR. ALSOP: Object as argumentative. MR. HUTCHINSON: Does that say University of Minnesota? MR. ALSOP: It doesn't, it doesn't. BY DR. BARDEN: Q It says Minnesota psychiatrists. Do you think it's a coincidence that drug maker payments to Minnesota psychiatrists has rose more than sixfold to $1.6 million during the 2000 to 2005 time period? MR. ALSOP: Now it's vague and it's lacking in foundation and it's argumentative, but go ahead. MS. AHMANN: Join. MR. HUTCHINSON: Join. 84

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THE WITNESS: I don't mean to slow the proceedings down, but the question had some parts. If you could just restate the question for me so I can respond. BY DR. BARDEN: Q Do you think that your coming to Minnesota and your relationships that you brought with drug manufacturers is

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related to what's reported in the New York Times, that is, the drug maker payments to Minnesota psychiatrists rose more than sixfold to $1.6 million from 2000 to 2005, the years when you have been the chairman of psychiatry at Minnesota? MR. ALSOP: Same objections. BY DR. BARDEN: Q Do you see a relationship -MS. AHMANN: Same objection. BY DR. BARDEN: Q A Q -- or not? No. It goes on to say, again, we're in Exhibit D, "studies present strong evidence that financial interests can affect decisions, often without people knowing it." Are you aware of any such research, Doctor? I am aware that there is sociology research in which sociologists have studied the fact of a person receiving 85

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a gift and the subsequent behavior. As far as the specific research that you pointed out here, I'm not aware of that. Have you read any of the social-psychological research on the effect of financial incentives? I've attended a lecture about it. Can you tell me any of the researchers that do any of that work? No. I don't know their names. Can you tell me of the economic research of the effect of

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financial incentives on decision-making? I don't know that research. Do you know anything about it? Well, I think I already indicated I've been to a grand rounds lecture about the topic that was given in our department probably in 2005. Are you aware of any other kinds of marketing research or additional research showing the impact of financial incentives on people's decision-making, even when they're not aware of such an impact? I think the studies that I alluded to earlier presented in the overall teaching grand rounds is my recent information or what I know about this. And when did you attend that? I believe it was in the end of 2005. 86

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Q

So during the time that Dan Markingson was in the CAFE study, of which you were a coinvestigator, you were not aware of the social-psychological, sociological, or economic research showing the effects of financial incentives on decision-making? MR. ALSOP: That's argumentative and misstating of his testimony, but go ahead, Doctor. MS. AHMANN: I join, and also raise lack of foundation. THE WITNESS: Yeah, it's difficult for me to say, to say that -- no, pardon me. It is easy. No, I'm not aware of that research.

BY DR. BARDEN:

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Q

And as you sit there now, you can't tell me any of the leaders of that research field, can you?

A Q

I don't know their names, no. Do you know, for example, if someone won a Nobel Prize for doing just that kind of research?

A Q

No, I don't know. It goes on to say, again this is Exhibit D, in Minn -MR. ALSOP: Counsel, what page or what -DR. BARDEN: We're on page 2 of 7, right in the middle. MR. ALSOP: Thank you.

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BY DR. BARDEN: Q "In Minnesota, psychiatrists collected more money from drug makers from 2000 to 2005 than doctors in any other specialty." Do you know why that might be, as the chairman of psychiatry, why would psychiatrists receive more money from drug makers than any other specialty? MS. AHMANN: Object to lack of foundation. MR. ALSOP: I'll join. MR. HUTCHINSON: Same. THE WITNESS: Without seeing that primary data, I don't know if I can agree to that, so then I can't speculate as to why that might be the case. BY DR. BARDEN: Q Okay. Well, for the purposes of this question, I'd like you to tell me if there is any reason why psychiatrists would receive more drug money than any other specialty.

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MS. AHMANN: Same objection. MR. ALSOP: Same objection. THE WITNESS: No, I can't.

Once again, we're looking at page 2 of 7, Exhibit D, "Dr. Stephen H. Hyman, the provost of Harvard University." You've heard of Harvard University? Yes, I have. Do you think being the provost of Harvard University is a 88

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fairly prestigious job in the academic world? Yes, I do. He's the former director of the National Institute of Mental Health. Do you think that's a fairly well-known job? It's a highly visible job for sure. And Dr. Stephen Hyman said, quote, "'There is an irony that psychiatrists ask patients to have insights into themselves, but we don't connect the wires in our own lives about how money is affecting our profession and putting our patients at risk,'" unquote. Would you agree with that statement from Dr. Hyman? I wouldn't. You would not. Yeah, that's correct. Do you know a Dr. Realmuto, George M. Realmuto? Yes, I do. Do you know if he's doing drug research at Minnesota? I know he has. I don't know if he is currently doing --

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I would say research with medications, but I don't know if he has any current medication protocols right now. Okay. Looking again at page 3 of 7 of what's been marked as Exhibit D, Dr. Realmuto said, well, here we're in the middle, "The money is nice, too, he said. Dr. Realmuto's university salary is $196,310." Quote, "'Academics don't 89

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get paid very much,' he said." Quote, "'If I was an entertainer, I think I would certainly do a lot better,'" unquote. Have you ever talked to Dr. Realmuto about his salary? I set his salary. Okay, so is that -So, yes, I have talked about his salary, correct. Is this statement accurate, to the best of -To the best -MR. ALSOP: You're not going to talk about Dr. Realmuto's salary. You're not to answer the question. BY DR. BARDEN: Q Okay. Is the sentence -- okay. MR. ALSOP: He's not going to comment upon -DR. BARDEN: He already did, that's fine. BY DR. BARDEN: Q Do you agree academics don't get paid very much, at 196,000 is not very much? I think Dr. Realmuto made some unfortunate comments in that article, and I did talk with him about it

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afterwards. MR. ALSOP: No, no, Doctor. The question is do you agree with that statement or not. If you don't -90

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THE WITNESS: Thanks for reminding me. The question again is do I think doctors get paid -MR. ALSOP: Paid enough.

Do you think $196,000 is not very much? I don't agree with that statement. Let's look at what's been marked as Exhibit D again, page 4 of 7. Dr. Steven S. Sharfstein, immediate past president of the American Psychiatric Association. Do you know him, by the way, have you ever met him? I have met him, yeah. That's a very prestigious job, isn't it -Yes. -- being president of the APA? Yes, it is. He said, "psychiatrists have become too cozy with drug makers." Do you agree with that? Not as a broad-brush statement, no. So you don't agree with Dr. Sharfstein and you don't agree with Dr. Hyman? MR. ALSOP: It's repetitious. We've established that twice now.

BY DR. BARDEN: Q In terms of the effect of money on the psychiatry profession, correct?

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 BY DR. BARDEN: Q A If you would. All right. the exhibit. Exhibit F. BY DR. BARDEN: Q Drug money.

MR. ALSOP: Now it's vague and ambiguous.

MR. ALSOP: That's vague and ambiguous and a misstatement of their quotes, but go ahead, Doctor. THE WITNESS: I don't agree with the statements in that article. DR. BARDEN: Okay. We'll mark this as

MS. AHMANN: What is it? MS. PEARSON: It is the CAFE study schizophrenia CME. (Schulz Deposition Exhibit F marked for identification.) MS. AHMANN: I think that's a misstatement. It isn't CAFE study. MS. PEARSON: I'm sorry. I was talking to Bridget, so I wasn't looking exactly at the title. DR. BARDEN: We'll let Dr. Schulz identify

THE WITNESS: Okay.

MR. HUTCHINSON: Well, you know, counsel, 92

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despite what you said earlier, I do want to be looking at

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the exhibit, if you're asking the witness about it, and I'm not at all troubled by having copies made here. We'll pay for them. DR. BARDEN: Yeah. MS. PEARSON: You have a copy in your production, you do. BY DR. BARDEN: Q A Okay. If you can identify that for the record, please? Can I just -- do I need to wait for him to get his copy? MR. HUTCHINSON: Just tell us what it is so we know what to look for. DR. BARDEN: We're going to spend about a minute on this document. THE WITNESS: Okay. BY DR. BARDEN: Q A Okay. This looks like a copy of a handout from a University of Minnesota CME program, cosponsored by the International Congress on Schizophrenia Research and the -- I was going to give the title of the program. Oh, sorry. The title of the program Schizophrenia Treatment Bridging Science to Clinical Care, and it's from April of 2006. This has been marked as Exhibit F. Okay. I'll show you 93

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page, this is the prepages, Roman numeral V, it looks like, and I will point you out to the bottom third of the page that says S. Charles Schulz, M.D. That would be you, sir?

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A Q A

That's correct. Can you read into the record what it says after that? It says -- this is taken from a form the CME office has people fill out. It says "Consultant," and after that it says "Eli Lilly, AstraZeneca," then it says "Speaker's Bureau," and I put "Eli Lilly, AstraZeneca; Grant/Research ... Abbott" Pharmaceutical, well, "Abbott, Eli Lilly; Honoraria: AstraZeneca," and it said "I do [not] intend to discuss off-label/investigative use(s) of the following commercial --" "I do intend to," I apologize, "do intend to discuss off-label use(s) of ... olanzapine, risperidone, quetiapine, ziprasidone, [and] aripirazole in teenagers."

Q

Okay. When it says "Consultant: AstraZeneca, Bristol-Myers Squibb, Pfizer," etc., those are companies that have paid you a consultant fee, correct?

A Q

Yes. Okay, and when it says "Speaker's Bureau," are those companies that have also paid you a speaking fee?

A Q

Correct. And when it says "Principal Investigator ... working 94

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directly for [the] company --" No, it says "or." Yeah, "Principal Investigator or working directly for company/company's agent," see it says AstraZeneca there, correct? That's under Dr. Olson's name. Oh, I'm sorry, I've gone down one. Yours is honoraria,

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it says AstraZeneca, correct? Well, let me make sure, because you read this part up here, working directly with, etc., etc., and that's at Abbott and Lilly. And then it says honoraria? Honoraria was a separate category, AstraZeneca. And this page is in the record, just to make it perfectly clear. Yeah. Okay, so okay. MR. HUTCHINSON: I didn't understand what that meant. This page is in the record? DR. BARDEN: This page is in the record, so there will be no confusion about what it says. MR. HUTCHINSON: You mean it's an exhibit to this deposition. DR. BARDEN: It is, it is. MR. HUTCHINSON: Oh, thank you. 95

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BY DR. BARDEN: Q Okay. Are there any drug companies for which you have received money other than the ones you've disclosed on this page? MR. ALSOP: It's vague as to time. Go ahead. DR. BARDEN: I think that's a very good objection. MR. ALSOP: Well, thank you. BY DR. BARDEN:

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Q

During the time that Mr. Markingson was treated at the Department of Psychiatry and was a subject in the CAFE study on which you were a coinvestigator, were you receiving funding from any drug company other than the ones that are listed on this page? MS. AHMANN: I'm going to object of lack of foundation, it's assuming that these he was receiving at the time, but, state my objection. MR. HUTCHINSON: I'm not sure where we are here. MR. ALSOP: I'm not sure there is a question. DR. BARDEN: There is a question pending.

BY DR. BARDEN: Q Are there any other companies than the ones listed there 96

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for which you were -- see, they make objections and then you answer the question. No, I understand. Just you were looking around, I didn't know. So let me be clear that the forms that are filled out that lead to these statements are for the 12 months preceding the conference. So this would describe the period of April 2005 to 2006, and my recollection would be that this is similar to my activities in 2004. Okay, so there are no companies other than the ones listed, to the best of your knowledge. I can't say for sure. Okay. DR. BARDEN: I'm going to have the witness

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identify this, and then we'll decide if we're going to make it an exhibit or not. BY DR. BARDEN: Q Can you identify this document for us? MR. HUTCHINSON: This is Exhibit G? DR. BARDEN: It might be. MR. HUTCHINSON: Oh. THE WITNESS: I don't recognize this. BY DR. BARDEN: Q Okay. On the front it says AstraZeneca results update, David Brennan. Do you know a David Brennan? I believe he works for AstraZeneca and I think -- let me 97

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see. The date is -2005, August. August 2005. Okay. Well, let me show you page 17 of this document. MS. AHMANN: Well, I'm going to object. MR. ALSOP: If you're going to go beyond that and talk about the document, I want it marked. DR. BARDEN: Yeah, we are going to mark it, if he recognizes it or if -MS. AHMANN: He said he didn't recognize it. MR. ALSOP: He said he didn't. DR. BARDEN: He recognized the name of the person that produced it, so now we're trying to determine if we're going to make -BY DR. BARDEN: Q I just want to show you these two graphs and ask you, to

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the best of your knowledge, if they're accurate. MS. AHMANN: Just a second. You're either going to make it an exhibit or not. He said he's not -THE WITNESS: I've not seen it. DR. BARDEN: These are speaking objections. MR. ALSOP: He's not going to respond. You asked him to comment on the accuracy. DR. BARDEN: We're going to make it an exhibit after he -98

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Q A second? BY DR. BARDEN: Q

MR. ALSOP: No. You did not ask him to identify it, you asked him if it was accurate, you didn't merely do -DR. BARDEN: To identify whether the information is accurate or not, that is correct. MR. ALSOP: He hasn't seen it before. MS. AHMANN: Do you have a copy? DR. BARDEN: You know, I don't. This will be Exhibit G, and you're welcome to look over our shoulder, if you like. There are two charts here, which I'm going to ask you questions about. MS. AHMANN: Can I see the cover, just for a

Okay? Let me do a little foundation. Have you ever been to any medical meetings where slides are shown? I have been to medical meetings where slides have been shown. And have there been charts and graphs shown at medical

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meetings? I've been to medical meetings where charts have been shown as well. And have you ever been to meetings where charts regarding the drug Seroquel has been shown? I think -- I have been to medical meetings where slides 99

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have been shown about Seroquel, and I'd like to take a break. Okay. You're certainly welcome to do that. MS. AHMANN: Are you going to talk about the document? Then I'd like to get copies for people to look on. MR. ALSOP: As long as we're taking a short break, we'll get copies, that's fine. MR. HUTCHINSON: Is this a document we've received before? MS. AHMANN: No. MR. HUTCHINSON: Then I'd like a copy, as long as we're going to review it. This might be a good time, if there are other documents we haven't seen before, that we can get a copy during the break. I'll be glad to pay for it. DR. BARDEN: Well, there are many documents. We don't know which ones will be exhibits yet, so we'll go through it as we can. All these documents -MR. HUTCHINSON: On the fly. DR. BARDEN: All these documents have been disclosed to you, is my understanding.

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MS. AHMANN: Yeah, she just said that it

MR. HUTCHINSON: But, counsel -100

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(Brief recess taken.) DR. BARDEN: We are back on the record. Just in terms of scheduling and moving things along, if we could go until like 12:30 and break for lunch, I think we can make some copies. Mr. Alsop has asked -MR. ALSOP: If he piles up a list of what he may use during that half-hour lunch break, I'll have our office make copies for everyone. DR. BARDEN: Rapidly. Okay.

Doctor, I want to go back briefly to what was marked as Exhibit F, which was the lecture summaries second biennial schizophrenia treatment at the Hyatt Regency presented by a number of agencies, including the Department of Psychiatry, correct? That's correct. 2006. And we had discussed, on page Roman numeral V, that you were going to discuss off-label/investigative use of a number of commercial products, including some drugs, correct? Well, let me double check, please. Go ahead, go ahead and check that, we'll make sure it's accurate. Okay. So page V says that I disclosed "I do intend to discuss off-label/investigative use(s) of the following

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

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question?

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MR. ALSOP: You answered the question, Doctor. He can make his objection. BY DR. BARDEN: Q This means that these companies provided financial support for this conference, correct? Correct. Thank you. Now, are you aware of any restrictions on companies marketing off-label uses for their drugs, for their medication? Yes, I am. Okay, but it's okay for them to finance a conference at which you, a physician, speak about or endorse off-label uses, correct? MS. AHMANN: I'm going to object, lack of foundation, misstatement. He talked about investigative uses as well. MR. ALSOP: You can answer, Doctor. DR. BARDEN: Uh-huh. THE WITNESS: What, you'd like me to answer? MR. ALSOP: Yes, go ahead.

But you as a physician can speak out and endorse or support off-label use of medications, correct? Not really, and why don't I just take a minute to address 103

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the question, if I could. Sure. I mentioned earlier that this conference was put on by the Department of Psychiatry and other agencies. We

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received CME support from, or accreditation, from the University of Minnesota. The money came from those companies through their educational grant office. The talks have to be judged to be fair, balanced, and not to be specifically recommending one treatment over another, if there is no basis for that. Okay, but you have given speeches where you recommend off-label uses of medications, correct? I have given talks where I've talked about research on off-label use for medications, that's true. Okay. Have you ever done that with a drug manufactured by AstraZeneca? Let me make sure I understand the question I'm answering. Have I ever given a talk about -Supporting off-label use of a drug manufactured by AstraZeneca, and by supporting, I mean you're either endorsing it, supporting it, presenting research evidence showing it's a good idea, etc. MS. AHMANN: I'm going to object, lack of foundation, misstates what he said. He said he has given talks about research. 104

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MR. ALSOP: I would join in that. It's a misstatement. He never suggested he supported it. But go ahead, you can answer. THE WITNESS: So I have given lectures about atypical antipsychotic medications in the area of chronic psychosis in people under age 18, and I have given talks about atypical antipsychotic medications for

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people with borderline personality disorder, for which there is no FDA drug. BY DR. BARDEN: Q A Q So that would include Seroquel, right? It would depend on the talk, but sometimes it would. So recommending Seroquel for bipolar disorder would be an off-label use, right? Okay. I have to be clear. I didn't ever say I recommended Seroquel. Okay. I'm not using the word recommended. Well, you just did. MR. ALSOP: You did. BY DR. BARDEN: Q A Q A Q Support, endorse, whatever. And I would not characterize my talks -But you've talked about the use of atypicals for bipolar. Pardon me? You've talked about the use of atypicals for bipolar? 105

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A

I didn't say anything about bipolar. MS. AHMANN: Okay. I join in that statement, misstatement.

BY DR. BARDEN: Q A What are -- what have you done? I described that I have talked about the research in the area of atypical antipsychotic medications in people under the age of 18, and I've talked about atypical antipsychotics for borderline personality disorder. Q Oh, I'm sorry, it was borderline, okay.

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MR. ALSOP: Let him finish, please. THE WITNESS: And that there is no FDA-approved medicine for borderline personality disorder. Further, in those talks, I've also described research results of other classes of compounds, such as SSRIs or anticonvulsive destabilizers. BY DR. BARDEN: Q And it is your understanding a representative, a direct employee of AstraZeneca, wouldn't be able to give such talks, would they? MS. AHMANN: Objection, lack of foundation. MR. HUTCHINSON: Same. MR. ALSOP: Go ahead, you can answer. THE WITNESS: My understanding of the roles would be that a person known as a drug rep, or 106

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pharmaceutical representative, whose job it is to visit doctors and visit hospitals, has to stay on the FDA-approved indications for compound. BY DR. BARDEN: Q Uh-huh. So one way the drug companies can get out information about off-label uses is to set up conferences and to hire speakers and to have them do it, correct? MR. ALSOP: Object as argumentative. MS. AHMANN: Lacking in foundation. MR. ALSOP: Argumentative, lacking in foundation. Go ahead, Doctor. MS. AHMANN: Join. THE WITNESS: I can't agree with that

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statement, no. BY DR. BARDEN: Q That's not a marketing tool that's used by manufacturers? MS. AHMANN: Same objection. THE WITNESS: I don't know. I don't know what their plans are. BY DR. BARDEN: Q How much does, to the best of your knowledge, and as someone who works with these medications and as someone who has a consulting relationship with AstraZeneca, how much money does AstraZeneca make from the sale of Seroquel in any given year? 107

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 repetitious. BY DR. BARDEN: Q BY DR. BARDEN: Q A

MR. ALSOP: Object as lacking in foundation, speculative. Go ahead, Doctor. THE WITNESS: I don't know.

Do you have any idea at all? I don't. MR. ALSOP: Don't speculate.

If Dr. Olson had stated it was probably more than 3 billion a year, would you disagree with that? MR. ALSOP: Object as speculative, also

THE WITNESS: I wouldn't know how to agree or disagree with that. BY DR. BARDEN: Q Do you have any idea at all of the market share of

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Seroquel? MS. AHMANN: Same objection. THE WITNESS: That's a different question, and I am aware that the, quote, market share of quetiapine is around 25 to 28 percent of antipsychotic prescriptions. BY DR. BARDEN: Q And how does that compare to the other antipsychotic prescriptions? 108

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A

I think it's tied with risperidone and is recently a little more than olanzapine.

Q

And what percentage of AstraZeneca's profits come from the sale of Seroquel?

A

I have no idea. MS. AHMANN: Objection.

BY DR. BARDEN: Q A Q You have no idea at all. Nope. We show you what's been marked now as Exhibit G. And this is a -- these are some slides from an AstraZeneca results update given by David Brennan and a U.S. business update for AstraZeneca given by Tony Zook, and an AstraZeneca US Seroquel update given by Johan Hoegstedt, and they're all dated 2005. Do you know a Tony Zook? MS. AHMANN: I'm going to object generally to the exhibit. I'm not sure where you got it. I haven't seen it before. To the extent it was produced in the MBO, I object that there is a protective order, to

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which you're not a party. Like I said, I don't know where you got it. So I'm also going to object as to the timing, the irrelevant to anything that happened here, and as to the lack of foundation. DR. BARDEN: For the record, this document is freely available on the internet for AstraZeneca. 109

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BY DR. BARDEN: Q So let me just go ahead and show you these two slides, which are on page 17 of what's been marked as Exhibit G. DR. BARDEN: Actually, we haven't marked it. (Schulz Deposition Exhibit G marked for identification.) BY DR. BARDEN: Q Okay. Dr. Schulz, do you see where it says, "Seroquel Continues to Drive the Global Atypical Market?" Do you see that? A Yeah, I see the type and the slide. MR. HUTCHINSON: I'm missing the page number, I'm sorry. MR. ALSOP: Seventeen. DR. BARDEN: Seventeen. BY DR. BARDEN: Q And it says, "Global Atypical Market $14 billion." Would that fit with what you understand the global atypical drug market to be, $14 billion. MS. AHMANN: Object, lack of foundation. THE WITNESS: I don't know. MR. HUTCHINSON: Same.

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THE WITNESS: I don't have any idea.

You don't have any idea at all? 110

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MR. ALSOP: It's repetitious. We've established he doesn't have any idea. BY DR. BARDEN: Q And then it says, "Seroquel Global Sales in 1H: $1.3 billion?" What's 1H? I don't know what that is. Have you ever seen this slide before? I don't recall ever seeing this slide before. Have you ever seen any market share slides of Seroquel before? You know, right below this, you have a slide that says market share. Yes. And I've been to a number of meetings over the years, and many companies present this slide, which is gathered from a national source. So I have seen slides like this in the past. So you've seen, you've been to a number of meetings where you've seen slides of the market share of various drugs, correct? That's correct. Okay, and on this one, 2005, it says, "Seroquel Leads the US Market in Share." Is that what that says? That's what the title is, of the slide is. And that would be consistent with the number you gave us,

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

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Have you discussed the increase in the financial worth of

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

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the hospital costs for those patients went way down, and so the net cost to a system was the same or improved. BY DR. BARDEN: Q And have more recent studies found those earlier research

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studies to be in error? I haven't read any recently. Have you read any recent studies indicating that the new -- well, let me back up a minute. How much more expensive are the atypicals than the older antipsychotics? MR. HUTCHINSON: What year are we talking about now? MR. ALSOP: Currently? BY DR. BARDEN: Q During the time that Mr. Markingson was treated in the CAFE study on which you were a coinvestigator. MR. ALSOP: Object on the basis of foundation, but go ahead, Doctor. THE WITNESS: Well, I think the best way I can answer that is that I'm aware that the medicine that was used a lot through the late '70s and '80s, haloperidol, is a generic medication and is particularly -- is inexpensive. I have heard in conversation, but I'm not sure I've seen on paper, that a person being managed with haloperidol, expense might be 114

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500 to 750 dollars a year. I don't have any current knowledge of the cost of risperidone or quetiapine or olanzapine for a year, but my understanding is the costs can fluctuate from $2,200 up to $5,000 or $6,000 a year. BY DR. BARDEN: Q Isn't it widely known in the psychiatric field and in the general public that the newer atypicals cost about ten

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times as much as the older antipsychotic drugs, and that this dramatically increased expense is leading to extreme struggles for states that have to finance these new drugs? MS. AHMANN: Object, lack of foundation, multiple question. MR. ALSOP: First of all, it's a multiple question, lacking foundation, it's irrelevant, but go ahead, Doctor. THE WITNESS: As I said before, I gave you estimates, and my understanding of the cost of the compounds, in a comparison. I don't know whether that's ten times more or not. I am aware that states and community mental health centers, veterans hospitals, are concerned about the increased costs of medications and trying to figure out how to best budget for those. BY DR. BARDEN: Q You just talked about early studies showing that the new 115

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atypical drugs actually have an economic benefit because they work better. Isn't that what you said? That's what I said. I think I said early studies. And you've given talks throughout the years about how much better the atypicals are than the older drugs, correct? Yes, I have. Okay. DR. BARDEN: Mark now Exhibit No. H, and I do have copies of that.

11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A Q BY DR. BARDEN: Q

(Schulz Deposition Exhibit H marked for identification.)

Have you read this article from the Associated Press, first published in the Washington Post? I don't believe so. Okay. Let's take a look at this. This is October 3, 2006. "Schizophrenia patients do as well, or perhaps even better, on older psychiatric drugs compared with newer and far costlier medications, according to a study published yesterday that overturns conventional wisdom about antipsychotic drugs, which cost the United States $10 billion a year." Would that be in keeping with your understanding, that the drugs cost $10 billion a year? MS. AHMANN: Object, lack of foundation. 116

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THE WITNESS: I don't know how much the drugs cost a year. BY DR. BARDEN: Q Okay. Third paragraph, "The study, funded by the British government, is the first to compare treatment results from a broad range of older antipsychotic drugs against results from newer ones. The study was requested by Britain's National Health Service to determine whether the newer drugs--which can cost 10 times as much as the older ones--are worth the difference in price." Were you aware of this study going on? Yes. When did you first become aware of this study?

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A

I think I became aware of it shortly before it was published, because psychiatrists such as Dr. Jeffrey Lieberman, who is quoted later, when he made presentations about the CATIE study, described a comparison study that was going on in England, and that was really about all I knew about it.

Q

Okay. "The study," down to the fifth paragraph, "The study, published in the Archives of General Psychiatry," and that's a good journal, isn't it?

A Q

Yes. That's a very reputable journal. Do you read that journal routinely? 117

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A Q

Uh-huh. Yes, I do. "Is likely to add to a growing debate about prescribing patterns of antipsychotic drugs. A U.S. government study last year found that one of the older drugs did as well as newer ones, but at the time, many American psychiatrists warned against concluding that all the older drugs were as good." "Yesterday, in an editorial accompanying the British study, the lead researcher in the U.S. trial asked how an entire medical field could have been misled into thinking that the expensive drugs, such as Zyprexa, Risperdal, and Seroquel, were much better." Quote, "'The claims of superiority for the [newer drugs] were greatly exaggerated,'" unquote, "wrote Columbia University psychiatrist Jeffrey Lieberman. 'This may have been encouraged by an overly expectant

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community of clinicians and patients eager to believe in the power of new medications. At the same time, the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical information,'" unquote. He's talking about some of your work, isn't he, Dr. Schulz? MS. AHMANN: Object, lack of foundation. BY DR. BARDEN: Q He's talking about "The claims of superiority for the 118

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[newer drugs] were greatly exaggerated," and he's -MR. ALSOP: Objection on the basis in foundation. MR. HUTCHINSON: Same. THE WITNESS: I don't have any idea. BY DR. BARDEN: Q Were you one of the people making claims of superiority for the newer drugs? MR. HUTCHINSON: Same objection. MR. ALSOP: Same objections. MS. AHMANN: Yeah. THE WITNESS: I have given a number of talks over the years as first clozapine and then other atypical agents have come out. I've showed data from those studies. The data I generally show is the pivotal trials that led to the FDA approval of the medications, and I will discuss during my talks that in the absence of movement disorder and a 90 percent, nearly 90 percent reduction in the onset of tardi dyskinesia, plus the

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demonstrated improvement in neuropsychological testing results, that on balance, the atypical antipsychotic medications are useful in treating schizophrenia. BY DR. BARDEN: Q So you don't agree with Dr. Jeffrey Lieberman that "'The claims of superiority for the [newer drugs] were greatly 119

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exaggerated?'" I don't agree with that statement. Is there a pattern in these? You don't agree with the past president of the APA; you don't agree with Steve Hyman, the head of NIH; you don't agree with Professor Pope, who is the only psychiatrist in the world to be in the half of one percent most cited in psychiatry and neuroscience; you don't agree with Dr. Hudson; you don't agree with a lot of these people. Do you feel like your opinions on these issues are unusual? MR. HUTCHINSON: Object to that as argumentative. MR. ALSOP: I'll join. MS. AHMANN: Join. MR. HUTCHINSON: Irrelevant, lacking in foundation, misleading, misstatement of the evidence, and inappropriate. MR. ALSOP: It's vague also. But go ahead, Doctor, if you can answer that question, go ahead. THE WITNESS: My response to your question is that the people you've mentioned, I all know. I know them all. I know Steve, I know Steve Sharfstein. And I

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think they're good doctors and good psychiatrists. You pointed out a sentence or two of some things that they've commented on, and I have not agreed with those 120

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statements, and I don't think that puts me in the position of being either argumentative or out of the mainstream of psychiatry. I really don't like being characterized by you that way. DR. BARDEN: Okay. Do you want to state for the record -- your objection that the question is inappropriate is by itself inappropriate. That is not a legal objection, and I'm not interested in people's personal opinions about questions. So let's -MR. HUTCHINSON: Well, I'm interested in proper questioning and not -DR. BARDEN: Keep your objections to legal objections. MR. HUTCHINSON: Not inappropriate -DR. BARDEN: You have no right to make a personal opinion like that in an objection, so don't do it again. MR. HUTCHINSON: I object. Counsel, just go -DR. BARDEN: You may make a legal objection, but not a speaking objection about your personal feeling. MR. HUTCHINSON: This isn't a contest of who can talk the most or talk the fastest or talk the loudest -DR. BARDEN: It's a legal deposition.

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

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to make that determination.

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

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foundation, speculative. Go ahead. MS. AHMANN: Same objection. BY DR. BARDEN: Q Let me back up. As a psychiatrist that does research in

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this area and as someone who's given talks and as a consultant to AstraZeneca, do you have to speculate on the percentage of patients that discontinue use of Seroquel? MR. ALSOP: It's now argumentative. THE WITNESS: Well, first of all, I'm not sure which question are we working on now? BY DR. BARDEN: Q Do you know the percentage of patients that refuse to continue taking Seroquel in drug trials? MR. ALSOP: Same objections. Go ahead, Doctor. THE WITNESS: My best answer to that is, in taking a look at the study Dr. Lieberman did, known as the CATIE study, in which dropping out of the study was, dropping out or choosing not to continue or having the doctor say not to continue, a substantial number of patients on all the medications in the study had discontinued by about the seven- to nine-month mark. So I can't quantify my answer, but just to point out that one of the things discussed about the 124

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CATIE study, which I think you have there in your lap, is the surprise to the field of how frequently patients are stopping medicines and switching to other medicines -BY DR. BARDEN: Q A Q But --- Seroquel included. Was there any difference in the discontinuation rates

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between those medicines? Yes, there was. The atypical antipsychotic medication, olanzapine, had a statistically significant advantage over all of the other medicines tested. In fact, the highest discontinuation rate was Seroquel, correct? I can't remember whether it was the highest or whether ziprasidone was. DR. BARDEN: Well, let's mark this. Exhibit I? MS. AHMANN: Do you have copies? DR. BARDEN: We're not going to talk about it for more than, just one number. (Schulz Deposition Exhibit I marked for identification.) BY DR. BARDEN: Q A If you could identify that for the record. This is a copy of an article from the New England Journal 125

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of Medicine dated September 22, 2005. The title of the article is Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia, and the lead author is Dr. Jeffrey Lieberman. Okay. I just want to look at the first page there. Yeah, here we are. "Results. Overall, 74 percent of patients discontinued the study medication before 18 months," and then it gives various percentages of discontinuation. Do you see, 82 percent? Yes, yes, I do.

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Q A Q

And that's for Seroquel. That's correct. And yet it still has the highest market share due to, as Dr. Lieberman said, quote, "the aggressive marketing of these drugs," unquote. MS. AHMANN: Objection, lack of foundation, speculation. MR. ALSOP: Object, lack of foundation, speculative. THE WITNESS: I don't know the connection between this and Dr. Lieberman's statement.

BY DR. BARDEN: Q To the best of your knowledge, is there an aggressive marketing campaign for Seroquel? MS. AHMANN: Object -126

1 2 3 4 5 6 7 8 9 10 11 12 13 A Q A Q to what? BY DR. BARDEN: Q

MR. ALSOP: Foundation, it's irrelevant. MS. AHMANN: -- foundation. THE WITNESS: If you can help me. Compared

Do you have any idea how much marketing funding is spent by AstraZeneca marketing Seroquel? No. You've never asked? No. Have you ever calculated how much money AstraZeneca stands to lose if states and institutions go back to using the older antipsychotic drugs?

14 15 16 17 18 19 20 21 22 23 24 25 that. BY DR. BARDEN: Q

MS. AHMANN: Same objection. THE WITNESS: No, I've never calculated

Certainly be in the billions of dollars each year, correct? MS. AHMANN: Lack of foundation. MR. ALSOP: I'll join, speculative. It's also repetitious. Go ahead. THE WITNESS: I'm slightly confused, because you showed me an exhibit here, you said it states, so.

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BY DR. BARDEN: Q A Q A Q A Q A I'm sorry? So I guess you're meaning if -If the market -Well, you mean worldwide. Yeah. If the world changed. I think that's fair. I think that if the world changed, that there would be a big impact on the pharmaceutical companies that make atypical antipsychotics. DR. BARDEN: I think let's go off the record now. (Lunch recess taken at 12:20 p.m.) * * * *

(Proceedings continued at 1:10 p.m.)

17 18 19 20 21 22 23 24 25 her. Great. BY DR. BARDEN: Q A

DR. BARDEN: We're back on the record?

Good afternoon. Good afternoon. DR. BARDEN: Does everyone have a copy of this? It's the UM IRB, starts 2811, Bates stamped 2811. MR. ALSOP: Yeah, I'll mark it, get it for

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Q A A Q A Q BY DR. BARDEN: Q

(Schulz Deposition Exhibit J marked for identification.)

Let me just ask you a series of questions first. Dr. Schulz, have you ever dealt with the University of Minnesota IRB? Yes, I have. What's your understanding of what the letters IRB mean? Institutional Review Board. And what is the purpose of the Institutional Review Board? The purpose is to assess research and to make sure that there is a provision for informed consent and safety of the research subjects. Okay. If someone from the IRB board said that their role was just to make sure a plan was in place, would you agree with that or not? MR. ALSOP: Object as vague. THE WITNESS: I'm not sure -- I don't

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understand the question. I'm sorry. BY DR. BARDEN: Q Well, hypothetically, let's say someone from the IRB board testified under oath that the IRB's job is not to ensure safety, but just to make sure that a plan is in place for each study. 129

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MR. HUTCHINSON: I'm sorry. Objection, lack of foundation. MR. ALSOP: I'll join. It's also vague. Go

THE WITNESS: My experience with members of our IRB, that sounds pretty superficial, and my experiences in talking with people at the IRB is that their understanding of what they do is what I previously stated. BY DR. BARDEN: Q Yeah, I mean, it's pretty well-known in the biomedical field that the role of the IRB is to ensure, e-n-s-u-r-e, patients are protected, right? MR. HUTCHINSON: Object to the form. THE WITNESS: I think I already said what I thought an IRB should do. BY DR. BARDEN: Q Okay. If you look at page, the first page of what's been marked as Exhibit J, it's UM IRB 2811. Under policy, "University of Minnesota Principal Investigators (P.I.) are responsible for the treatment of human subjects." Is that your understanding, Dr. Schulz?

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A

If you give me a second. I understand you're asking me the question. So, yes, that is my understanding, and this is a relatively new document for our university, 130

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

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

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afternoon?

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Q A Q

Correct. No. Have you had any classes or training in the duties of a coinvestigator on a drug trial study?

A

As I discussed earlier, the University of Minnesota has a responsible conduct research class, not specific to coinvestigators, but the conduct of research, and I took that course and was certified.

Q

Okay. Did Dr. Olson ever come to you and say that he had written to a court that Dan Markingson lacked capacity to make informed judgments, but that he had signed him in as a subject in the study? Did Dr. Olson ever comment, present that issue to you? MR. HUTCHINSON: This is repetitive. MR. ALSOP: Objection, repetitious, but go ahead one more time. THE WITNESS: I don't recall any conversations like that.

BY DR. BARDEN: Q Did Dr. Olson ever come to you discussing potential coercive effects on court orders of any of your subjects? MR. ALSOP: Objection, repetitious. THE WITNESS: No, he did not.

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BY DR. BARDEN: Q Do you have any special policies or procedures at the University of Minnesota for patients, for research subjects who have been coercively influenced by court

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orders? MR. ALSOP: Object as argumentative, misstating the facts, and foundation, but go ahead. MR. HUTCHINSON: Join. THE WITNESS: My understanding is that a patient who is committed still retains the ability to consent for certain issues. In other words, a patient may be committed to our hospital, and still voluntarily consent to receive a medication treatment, as an example. BY DR. BARDEN: Q A Patients receiving neuroleptics supposed to sign a form? Our hospital does have a policy that, there is a sheet that they are supposed to sign that describes the side effects of medications so that they understand it. Is there any special form to be signed for the use of neuroleptics, other than what you've discussed so far? That's what I thought I just described. Did Dr. Olson ever inform you that he did not have Dan sign that when he used neuroleptics on him in the hospital? MR. ALSOP: Object as repetitious. Go 134

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ahead. MR. HUTCHINSON: Same. MR. ALSOP: Go ahead, you can answer. THE WITNESS: I understand what happens, is unfortunately -MR. ALSOP: You hear me. THE WITNESS: Yeah. What was the question

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again? BY DR. BARDEN: Q Did Dr. Olson ever inform you that he treated Dan Markingson with neuroleptics in the hospital without having him sign such a form? No, he did not ever tell me that. Would you have concerns, if he had in fact done that? I would want to know more about it, yes. Would those kinds of violations of procedures be something you would report, or would you discuss it personally with Dr. Olson? MR. ALSOP: Object to the form of the question as plural, and misstating the facts, and it's duplicative, but go ahead. MR. HUTCHINSON: I'll join. Lacking foundation. DR. BARDEN: Okay. I think that's fair.

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BY DR. BARDEN: Q It happened one time. He put him on neuroleptics, but never got the form signed. Would that be something you would report or discuss with him personally? MR. HUTCHINSON: Well, counsel, are you asking him to assume this witness became aware of that? Because I thought he said he didn't, Dr. Olson didn't tell him that. That's where I'm a little lost. DR. BARDEN: Okay, and I'm having trouble with your speaking objections, again, which you're

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actually coaching the witness, which are highly improper. If you have -- the proper objection for that is lacks foundation, calls for facts not in evidence, and that is all that you get to say. You don't get to coach the witness on what he said or what his memory was or whether reported. That's not appropriate. Let's stick to the legal objections. Okay? MR. HUTCHINSON: Maybe you intend to ask misleading questions, but I thought the question -DR. BARDEN: Then you get to bring that up with the court. You can state it states facts not in evidence, you can say misleading, but you can't give a speech that informs the witness what your theory of the question is. That's highly inappropriate. Thank you. MR. HUTCHINSON: Read -- you're going to 136

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restate it or do you want it read back, the question? DR. BARDEN: I'm just going to go and ask questions, and I hope you're just going to use legal objections. BY DR. BARDEN: Q You mentioned that you would find it a concern if a psychiatrist in your department had treated a patient with neuroleptics, but not had them sign the neuroleptic form, correct? I did. But what level of concern would you have? Would you report the doctor to someone or would you just speak to them privately?

14 15 16 17 18 19 20 21 22 23 24 25 but go ahead.

MR. ALSOP: Object as vague as to report,

THE WITNESS: I'd like to answer the question by describing the process on the wards, where the faculty at the University of Minnesota are one of the groups admitting. So patients can be referred in to one of our, one of the University of Minnesota Medical Center at Fairview wards. When they're admitted, they can't go onto the ward until the staff has either, in the emergency room or as soon as they come to the ward, signed a consent form consenting to be in treatment, or 137

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if they were hypothetically committed to us. There are meetings every day, and the nursing staff who meet with the doctors, in my experience on those wards, say you've prescribed an antipsychotic medication, we have to now obtain the neuroleptic consent form. So how it turned out that, your description, that Dan did not sign this form is concerning to me, because of the daily team meetings with the head nurse, the social worker, the psychiatrist, the resident, and that my experience is you go through this every day on every admission. So I don't know how it happened. And hearing about it now, I would want to look into how could a person not have signed the form. You know, there may be other circumstances I'm not aware of. But follow your question, yes, that does

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concern me and I would want to look into it further, and it would depend on what happened as to whether it would come to some committee or be handled by the medical director of that unit and Dr. Olson. BY DR. BARDEN: Q How would a faculty member or staff person file a complaint if they noticed something like that? What would be the proper procedure? Sure. 138

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Q

During the time Dan Markingson was in the CAFE study and being treated at Fairview.

A

Well, as we discussed this morning, there are forms, and there were forms, paper forms, on the unit during the time of late 2003 and 2004, and if a staff member, nurse, social worker, psychiatric tech, had a concern that something had not gone correctly, they would fill that form out and turn it in to the hospital administration, Fairview Behavior Services. They would examine it, and they would either direct the complaint back to the unit and have the medical director of the unit meet with the person who brought the complaint or person that brought the complaint, the head nurse, and if the complaint was about a psychiatrist, meet with them and solve the problem.

Q A Q

So that was the system in place -Correct. -- but the audit we discussed indicated that a very significant percentage of the people working on those

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units didn't feel like they'd be protected from retaliation, if they complained, correct? MR. ALSOP: That's argumentative and a misstatement of the facts in his prior testimony in this case when you asked him about those issues. MR. HUTCHINSON: Same, and lack of 139

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foundation. MR. ALSOP: Go ahead, Doctor. THE WITNESS: So the process I just described to you is a University of Minnesota Medical Center process for work on our wards. The audit that we discussed earlier was a questionnaire of the secretaries, the grant accountants, and the academic faculty within our faculty area, and did not address at all the scenario you described regarding the ability of people working on the wards to make a complaint to the hospital about what was going on. So, therefore, none of the people on the wards were the object of this audit. BY DR. BARDEN: Q Has there been a survey audit done on those hospital wards? I don't know. Do you have any reason to believe it would be any different or maybe even much worse than it was in an academic setting? MR. ALSOP: Object, argumentative. DR. BARDEN: I'm sorry. Let me rephrase

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that. BY DR. BARDEN: Q What, if anything, information do you have indicating 140

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that an audit done in the wards would provide any different data whatsoever than the one done in the grant office? I'm not aware of -MS. AHMANN: Objection, lack of foundation. MR. HUTCHINSON: Same. THE WITNESS: I'm not aware of any audit performed in a similar process to the one the University of Minnesota does for its academic faculty and staff. BY DR. BARDEN: Q Are you aware of any widespread knowledge in the medical field that nursing staff often feel that if they file complaints, they'll suffer serious retaliation? MR. ALSOP: Speculative, lacking foundation. Go ahead. MR. HUTCHINSON: Same. THE WITNESS: I'm not aware of any literature, but it's certainly not been my experience at University of Minnesota Medical Center. BY DR. BARDEN: Q Ever had any nurse mention to you that they were worried about retaliation if they reported a doctor for something? I have not, no.

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Q

Look at page, the next page of what's been marked as Exhibit J.

A

What number is that? MR. ALSOP: Just next page. DR. BARDEN: Just very next page. MR. ALSOP: In front of you.

BY DR. BARDEN: Q It's UM IRB 2799. It says, "Research Involving Human Participants Unable to Consent-Surrogate Consent." A I'm still not caught up with you. Is this page 1 of 3? MR. ALSOP: Yes. THE WITNESS: Where are we looking? BY DR. BARDEN: Q We're looking at under policy. Second sentence, "Research involving subjects who are mentally ill or subjects with impaired decision-making capacity warrants special attention." Would you agree with that sentence? A Q Yes. Did you know that Dr. Olson had signed a form to a court saying that Dan Markingson was mentally ill and lacked capacity within a few days of when he had him sign an informed consent form? MR. ALSOP: Counsel, this is about the fourth time you've asked that question, and he'll answer one more time and not again. Go ahead. 142

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THE WITNESS: I was not aware of that, no.

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BY DR. BARDEN: Q Is there any system in place in the Department of Psychiatry to catch patients like that, that is, patients who have been signed up for informed consent, but, in fact, there is medical information directly in their current file saying they lack capacity for informed consent? What, if any, systems do you have in place to catch that mistake? MR. ALSOP: Object as argumentative, misstatement of the facts. MS. AHMANN: Join. MR. HUTCHINSON: Same, lack of foundation. THE WITNESS: So to answer your question, my understanding is that you're asking about whether Dr. Olson indicated that the patient was incompetent to provide informed consent. BY DR. BARDEN: Q That he lacked capacity, was mentally ill, was not aware that he was mentally ill, etc., yes. MR. ALSOP: And the question is how you catch that issue? DR. BARDEN: Yeah. MR. ALSOP: Okay.

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BY DR. BARDEN: Q What is in place when you have a medical chart and documents to a court saying this patient believes that his family members are lizards, for example, or he's in a

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Satanic cult, I mean, that he's grossly psychotic, and they use the phrase lacks capacity, and they say that he should be petitioned to a court for commitment and they say that he's grossly psychotic, and then he's signed into a research study on his own signature? Was there a system in place during this timeframe, that is, December of 2003, was there a system in place that would have caught that error; and, if so, what was the system? MR. ALSOP: Assumes facts not in evidence as to the last comments, it's multiple and argumentative, but go ahead. MS. AHMANN: Join. MR. HUTCHINSON: Same, and lacks foundation. THE WITNESS: So the investigator, Dr. Olson in this case, needs to pass the responsible conduct to research course we've discussed. The people helping Dr. Olson, the project coordinators or research assistants, have courses in certifications they need to pass on the same material. In addition to that, Dr. Lieberman, who we discussed earlier, the head of the CATIE study published in the New England Journal of 144

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Medicine, used the same clinical research organization that the NIMH certified to also run the CAFE study, and they closely, to my understanding, closely monitored this study. So there were research assistants, project coordinators, as well as monitors for the study in place, in my opinion, in order to make sure that the protocol

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was being followed. BY DR. BARDEN: Q And isn't it in fact the case, Doctor, that regardless of what kind of system you have like that, if you had a psychiatrist who had a large financial and professional interest in aggressively recruiting subjects and was under a lot of time pressure to recruit subjects, and if they had decided to obtain those subjects by using the coercive power of the legal system to obtain a subject, that system, a system you're describing, couldn't catch all those doctors, could it? MR. ALSOP: Object as a multiple question, argumentative, misstates the facts. Go ahead, Doctor. MS. AHMANN: Same. MR. HUTCHINSON: Join, and lacks foundation. MR. ALSOP: Go ahead, if you can answer it. THE WITNESS: You've described a scenario that I can't agree to, but I will comment that Quintiles, 145

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to my understanding, developed an outstanding reputation through their contact at the CATIE study that you showed me, and that they have no connection with Dr. Olson, and would want to make sure that the study was run properly. They don't get any reward one way or the other. They just want to make sure the study is run. BY DR. BARDEN: Q But Dr. Olson's contract, he gets paid by the subject he recruits, correct? No, he doesn't.

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Q

The study does. There is a $16,000 payment per recruitment, correct?

A

Well, you have two questions going. You have doesn't Dr. Olson make money, and then you describe the subject of the study. So if you'd like to break it down, I'll be happy to do my best to answer.

Q

Well, let's talk about that. You're an academic psychiatrist, correct?

A Q A Q A

I am. And so is Dr. Olson, correct? That's correct. And your reputation depends upon publishing, doesn't it? Not all -- let me just back up a second. At the University of Minnesota, there are multiple academic tracks. Some faculty members, no matter what the 146

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clinical department at the medical school, are in a clinical scholar track, for which publication -- can I finish? Yes, but I'm going to move to strike as nonresponsive, and then we'll just start over. MR. ALSOP: Why don't you let him finish answering his question. If he doesn't like it, he can make his objection. But go ahead. THE WITNESS: I believe you asked me about whether his reputation is based on his ability to publish, and I was describing that he was in an academic track at the University of Minnesota for which publications, per se, are not a necessary requirement for

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his promotion. DR. BARDEN: Move to strike as nonresponsive. BY DR. BARDEN: Q I didn't ask you if they were necessary. Dr. Schulz, you work in a university environment, correct? I do. People in a university environment have their reputations enhanced by publishing peer-reviewed research articles, correct? No. So you think that Dr. Olson's reputation is not enhanced 147

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by publishing peer-reviewed research articles. Dr. Olson's overall reputation at the University of Minnesota is based on his ability to take care of patients, to teach, participate in research projects. He has not been a person writing a lot of first authored articles and has been an outstanding faculty member. DR. BARDEN: Objection, move to strike as nonresponsive. BY DR. BARDEN: Q You're telling me under oath that you think Dr. Olson's reputation will not be enhanced by publishing peer-reviewed journal articles? MR. ALSOP: It's argumentative. DR. BARDEN: I didn't say completely, I didn't say it's the most important thing, I didn't say it's necessary. We can play these word games all day.

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MR. ALSOP: Yes, you can.

Isn't it true that every licensed health care provider that works in an academic setting would rather publish than not publish? MR. ALSOP: Object on the basis of foundation, argumentative, and repetitious. Go ahead. MR. HUTCHINSON: Join. MS. AHMANN: Join. 148

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THE WITNESS: Well, I think to make it easy and move ahead, Dr. Olson's reputation as a psychiatrist would be improved if he were to publish in the medical literature. BY DR. BARDEN: Q Now, let's go back to your resume for just a second, a few things that I forgot to ask you. We had looked at whether you'd ever published anything on medical ethics. Do you remember that? Yes. You talked about the Hastings Report, and we talked about the fiduciary duties to patients briefly. Let me ask you, have you ever published an article related to unethical behaviors of researchers, have you ever published anything on that whatsoever? I don't recall. Have you ever published anything that relates in any way to the history of misconduct by psychiatric researchers or therapists?

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A Q

I don't recall publishing an article on that. Have you ever published anything at all with regard to the history of patient abuse in psychiatric research?

A Q

Not that I'm aware of. Are you aware of any famous litany of patient abuses in psychiatric research? 149

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MR. ALSOP: Object as vague and ambiguous and irrelevant, but go ahead. THE WITNESS: Could you restate the question? I'm sorry, I just got distracted. BY DR. BARDEN: Q In the history of psychiatry, are you aware of some significant patient abuses in research? MR. ALSOP: Same objections. Go ahead. THE WITNESS: Yes, I am.

Can you describe some of those for me? Well, the one that comes first to mind is the work of Dr. Walter Freeman, psychiatrist who, pardon me, a neurologist, not a psychiatrist, who perfected a treatment that began in Europe called prefrontal lobotomy, and he performed this treatment; and as the new medications at that time were introduced during the 1950s, there were concerns brought about his continuing to continue prefrontal lobotomy treatment now that newer and psychotic medications treatments were available. Freeman, he invented the ice pick procedure which let it go rapidly, correct?

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A

I think I already stated he perfected a technique that had been started in Europe.

Q

By a psychiatrist. Do you know that person's name? 150

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A

Moniz. A Nobel Prize winner, so you were talking about Nobel Prize winners.

Q

Uh-huh. Is he the last psychiatrist to win the Nobel Prize?

A Q A Q

No. Who else? Eric Kandel from Columbia. So other than lobotomies, can you tell me about some other famous patient abuses in psychiatric research?

A Q A

None come to mind right now. You're not aware of any LSD experiments, for example? The only vague memory I have is maybe 20 years ago going to a symposium at APA in which the presenters talked about wanting to reinitiate LSD research to better understand how serotonin worked in the brain, and there was discussion about the pros and cons of using LSD in research.

Q A Q

Anything else? No. You're not aware of any research involving so-called repressed memories or multiple personality disorder?

A Q

I'm not. A number of psychiatrists lost their license over that? You're not aware of that?

A

No, I'm not.

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Q

Were you ever aware that there was a problem in the psychiatric field with regard to multiple, so-called multiple personality disorder?

A

I think only from the newspaper articles or psychiatry news, newsletters, about the difficulty of making the diagnosis and, you know, certain legal issues that came up regarding repressed memory, and that there were pretty heated debates back and forth between clinicians about that.

Q

Are you aware of the multiple license revocations that took place as a result --

A Q

No, I'm not. -- of all that? So on this document that we're looking at, which has been marked Exhibit J, so you never discussed with Dr. Olson applying for surrogate consent for any of your subjects in the CAFE study, correct? MR. ALSOP: Object as vague and ambiguous, but go ahead. THE WITNESS: I'm sorry, I don't understand. Could you restate it, maybe give it again?

BY DR. BARDEN: Q We're looking at a document Research Involving Human Participants Unable to Consent-Surrogate Consent. A Q I'm sorry, where -The same document we've been looking at, Exhibit J. 152

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A

Yeah, I understand. Where are we looking now?

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Q

You see where "Investigators must apply to the IRB for use of surrogate consent that is specific to the ... study being reviewed." My questions's a very simple one. Did you and Dr. Olson have a discussion about how to deal with patients who were grossly psychotic, lacked capacity, as to whether they would be able to join your research study, how to, again, get informed consent from someone who is psychotic at the time?

A Q

No. Did you have any methods or procedures in place to have a surrogate give the capacity for such patients, that is, patients who are currently grossly psychotic and lacked capacity to give an informed consent? MR. ALSOP: Object as repetitious. We've discussed those already. But go ahead. THE WITNESS: I do not believe -- well, I know that it was not discussed.

BY DR. BARDEN: Q A Q Okay. I think that answers your question. Since the IRB at the University of Minnesota knew that these were subjects that had schizophrenia, right? A Q That's correct. And that schizophrenia is a mental illness, correct? 153

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A Q

That's correct too. And that schizophrenia can result in people having impaired decision-making capacity, correct?

A

They can.

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Q A Q

They can? Not always, but can. And given that the IRB knew that, what, if any, steps did they take to ascertain whether you were going to use surrogate consent? Did they send you new requests for information on that? MR. ALSOP: Object as lacking in foundation. THE WITNESS: No. MR. ALSOP: Vague and ambiguous. THE WITNESS: I don't know -- they didn't send anything to me. I don't know if they sent anything to Dr. Olson.

BY DR. BARDEN: Q To the best of your knowledge, did the IRB conduct any investigation whether some of your subjects needed a surrogate in order to get informed consent? MR. ALSOP: Same objection as to foundation. MR. HUTCHINSON: Same. THE WITNESS: I am not aware of any investigation the IRB might have done.

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BY DR. BARDEN: Q Then on the next page, which is page UM IRB 2800, at the very bottom, last sentence it says, "Under no circumstances may subjects be forced or coerced to participate." Do you agree with that? A Q Yes, I do. But you don't agree that a court stay of commitment,

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which threatens to put someone in the state mental hospital if they don't comply with a directive to enter a treatment study, you don't think that's coercive, right? MR. ALSOP: It's repetitious, asked and answered at least three times. Go ahead. MR. HUTCHINSON: Join, and lack of foundation. MS. AHMANN: Join. THE WITNESS: I believe the patient had a choice of either being in the study or continuing treatment at another hospital. BY DR. BARDEN: Q A Q Did you ever read the court order in this case? No. So what's the foundation for your belief that he had a choice, if you haven't read the court order? Let me back up. My belief is based on working on the wards and the use of the stay of commitment procedure on 155

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those wards. Okay. How many other patients do you have or have you had in your studies who was, A, court-ordered to follow the treatment recommendations of their treater; and B, had a treater that recommended the CAFE study only? How many patients have you seen like that, had a court order to follow the recommendations of the treatment team, the treatment team said you're going into CAFE? I'm not aware of any other patients in the CAFE study that that happened to.

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Q

Look at -- continuing on what's been marked as Exhibit J, if you look at the bottom right, there are some little handwritten page numbers. If you go to page 6, I'm sorry, 7 of that, the top right it says page 701, the Bates number for this is UM IRB 2793. Do you see under E where it says, "Does the consent form: Disclose alternative procedures which may be advantageous to the subject?"

A Q A Q

Yes, I do. Okay. Have you read the consent form in this case? No, I haven't. It discloses no alternative procedures whatsoever, does it, Doctor? MR. ALSOP: Lacking in foundation. He's told you he hasn't seen the form. 156

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BY DR. BARDEN: Q A Q Have you ever seen the CAFE study informed consent form? No, I haven't. So as a coinvestigator of this study and as someone who is listed as ten percent, as a ten percent coinvestigator, you never saw the informed consent form for this study, correct? MR. ALSOP: Have you heard the last three answers when he says he hasn't seen it? Are you confused? You don't have to answer that question. Don't answer that question. BY DR. BARDEN: Q You didn't think you had a duty to look at the informed

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consent form? MR. ALSOP: It's argumentative. Go ahead, you can answer that question. THE WITNESS: No. BY DR. BARDEN: Q Have you, in your other studies, have you used informed consent forms which disclosed no alternative treatments? MR. ALSOP: Object as vague and ambiguous. THE WITNESS: Seeing that you're asking me about what I do, I would say that when I'm participating in clinical research, if a person who is currently a patient is referred, we say that you can participate in 157

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the research or you could go back to the community mental health center and get treatment, or we will try to find a psychiatrist for you. That's the way I work. BY DR. BARDEN: Q A So you'd put that on the form? I wouldn't put it on the form. I would do it in the discussion of the patient prior to initiating the informed consent process. Okay. I'm sorry. Let me try to make this a little clearer then. We're looking at the University of Minnesota IRB forms, correct? Well, I don't know that. You've kind of -This is the University of Minnesota printout -I was trying to answer a question. I'm sorry. Thank you.

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Q

But there was a confusion, because I was asking you about a form, f-o-r-m, form, what's on the paper, and if we look at what the page we've been looking at, which is Bates No. UM IRB 2793, it says, "Does the consent form: Disclose alternative procedures which may be advantageous to the subject?" It doesn't talk about a discussion, it doesn't talk about a clinical chitchat session; it talks about the form. My question to you was: When you're 158

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conducting your own research and you are responsible for the form, do you put alternative treatments, risks, and benefits on the form in that informed consent? MR. ALSOP: It's a misstatement of this document and what it contains, it's argumentative and vague, but go ahead, Doctor. MS. AHMANN: Join. MR. HUTCHINSON: Join. THE WITNESS: I think what I'd like to do to answer, you've directed me to No. E, which obviously appears to me to be part of a longer section. I'd like to just look back -DR. BARDEN: Objection, move to strike as nonresponsive. BY DR. BARDEN: Q And I'm not asking you about what's on the form now. I'm asking you, in your own research, you have informed consent forms, correct? That's correct.

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Q

Do you put alternative procedures, treatments, benefits, and risks of alternatives, on your consent form or not?

A Q

Well, I'm awfully -- I think I am. I think I do. And those forms would be available, would they not; they would be something that the University holds onto? MR. ALSOP: Object to as vague and 159

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ambiguous, but go ahead. BY DR. BARDEN: Q Well, let me ask you this: As a PI in some studies, how many years do you have to keep informed consent forms for drug studies. I don't know for sure, but five or seven. So then you would have several studies on which you are currently involved and which you have those forms currently stored, correct? MR. ALSOP: That's a misstatement of his prior testimony, go ahead. THE WITNESS: I'm not sure there is several. I don't know how many there are. BY DR. BARDEN: Q How many studies have you been a PI in in the last five years? I'm thinking of two or four. Okay, so you would have these, at least have the forms for those studies? Yes, that's correct, that's right. And seeing as the -DR. BARDEN: Objection. There is no question before the witness.

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MR. ALSOP: Go ahead and --

Let's go to the next page, it's page, look at the bottom 160

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right, it says 8, UM IRB 2786. Under policy, again, this is University of Minnesota IRB site, is under consent process and under policy, do you see right in the middle of the page, it says, "In reviewing a proposed research study, the IRB determines if the setting, timing, and procedures for soliciting informed consent are acceptable and whether the consent process should be monitored." Is it your understanding that that's accurate, that that is the IRB policy of the University of Minnesota? Yes. Okay, and then it says in the next paragraph, "Under the regulatory requirements the consent process should fulfill these attributes," and we're looking, I'm looking at the middle one that says, "The consent process minimizes the possibility of coercion or undue influence." Do you see that? Yes, I do. Do you agree with that? Yes, I do. Do you know what a HIPAA form is? Well, I think I know what HIPAA is, but I'm not sure what you mean. Okay. What's your understanding of HIPAA? HIPAA, my understanding is regulations related to the

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

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statements to people outside the University?

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A

No. MR. ALSOP: It's argumentative and misstatement of the facts. He's answered.

BY DR. BARDEN: Q Do you, when you're doing a study, do you distinguish between consent to participate in research and consent to treatment? A Q Yes, I do. Did Dr. Olson ever come to you and say, whoops, I didn't distinguish between consent for treatment and consent for research with Dan Markingson? A Q No, he did not. Do you know that he told us that he was Dan's treating physician till the day Dan died? A Q I didn't know he told you that. Would that surprise you? MR. ALSOP: It's now irrelevant, but go ahead. THE WITNESS: It would not surprise me. BY DR. BARDEN: Q Would it surprise you if he hadn't seen Dan more than once or twice in months before Dan's death? MR. ALSOP: It's argumentative, irrelevant, and a misstatement of facts, but go ahead. 163

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MS. AHMANN: Join. MR. HUTCHINSON: Join. THE WITNESS: That would surprise me.

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Q A Q

Pardon? That would surprise me. With a psychotic patient, a schizophrenic in a drug study like this, how many times would you expect that patient to be treated by a psychiatrist, whether it's the study or whether it's an outside psychiatrist? An ongoing schizophrenic, mentally ill person, how often should they be seeing a psychiatrist? MR. ALSOP: That is now a multiple question in two different settings, it's vague and ambiguous, lacking in foundation. Go ahead and answer if you can. MS. AHMANN: Join. MR. HUTCHINSON: Join in all those. MR. ALSOP: You can answer that question. THE WITNESS: Well, let me start by describing to you what I perceive the standard of care around the Twin Cities or the State of Minnesota to be. The frequency of visits is, from what I hear from my patients and community meetings I go to, is with a psychiatrist probably seeing a schizophrenic patient about four times a year. At the appointments of the 164

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mental health centers are frequently 15 minutes in duration with a psychiatrist and the psychiatrist then, in working with the treatment staff, writes a prescription and an appointment is made for the next two to three month. My feelings are, is that in our community, if a person is having an emergency, they will, say,

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frequently come to our behavioral evaluation center, where we have two psychiatrists from University of Minnesota Medical Center on duty, if there is a crisis, and then if a change in the focus of care is needed, they would call the attending or figure out what the treatment plan would need to be after that. DR. BARDEN: Move to strike all portions of that response that are nonresponsive to the question, and move to strike all parts of the witness's answer with regard to, quote, standards of care, unquote, since he's already testified he rarely does clinical work, or less than ten percent of his time. And let me reask that. MR. ALSOP: And I'm going to respond, I'm going to respond. MR. HUTCHINSON: Sounds like a speaking objection. MR. ALSOP: That sounds like a speaking objection to me too. But my response is you asked him 165

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how often do you expect a patient to be seen in this community, and he responded to the question. DR. BARDEN: And he responded far beyond the question, and I'd move to strike those parts. That's all. MR. ALSOP: That's why I have to say then, you don't have to go on any further. DR. BARDEN: Uh-huh. MR. ALSOP: That's entirely inappropriate. BY DR. BARDEN:

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Q

So in your informed consent forms, do you disclose conflicts of interest when you're doing research?

A

What we do in our consent forms is disclose who the study sponsor is. I don't think that I put in my consent forms that I would consult for a company or give lectures.

Q

Let's say, for example, the study -- or the individual has a financial incentive to keep people coming back; the longer the person stays in the study, the more money they get from an outside agency, whether to them or their university or their study or whatever. That's a conflict of interest with the patient, isn't it? MR. ALSOP: That's argumentative and misstatement of the facts and multiple, but go ahead. MS. AHMANN: And lack of foundation. MR. HUTCHINSON: Join. 166

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THE WITNESS: The statement you've made, in my opinion, does not describe what happens at the University of Minnesota, so I don't agree with -- so I'd have to say no to the question. BY DR. BARDEN: Q So hypothetically, someone had a contract where they're paid by the visit. Yup. Either the university is paid or the institution is paid or the individual is paid or the research study is paid. Can we stay with your first question? No, no. You asked a question, and then you don't let me answer.

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Q

So there is a system in place where every time a patient comes and completes a visit, there is money paid. Do you understand that so far? Person visits, there is money paid. If someone stays for 20 visits, there will be more money paid than if they leave after two visits. There is a financial incentive to keep the person in the study. That's the hypothetical. And then isn't that a conflict of interest with patient care, where the physician does not have a typical outside treating physician, does not have this extra incentive from an outside, let's say a drug company, for example, will be paying money per visit? 167

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A Q

For the work performed. Yeah. Shouldn't that be disclosed on an informed consent form, that kind of conflict of interest? MS. AHMANN: I'm going to object. That was a very multiple question, and I don't know what the specific question is which he's expected to answer. MR. HUTCHINSON: Same objection, lack of foundation, and calls for a legal conclusion. MR. ALSOP: I'll join. Go ahead. THE WITNESS: My opinion is that here at the University of Minnesota, there is a statement on the consent form that describes who the sponsor of the study is, and that those forms are approved by our Institutional Review Board, and I do not believe there is a conflict of interest in the scenario you described.

BY DR. BARDEN:

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Q

And the forms that are approved by your IRB do not disclose whether they get paid by the visit, do they? MR. ALSOP: Object on the basis of foundation. He hasn't seen it. DR. BARDEN: He's seen his own forms, he's so testified. MR. ALSOP: What forms are we talking about? It's vague now. DR. BARDEN: Talking about forms approved by 168

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the IRB. MR. ALSOP: Vague as to forms, but go ahead. BY DR. BARDEN: Q Have you ever seen a form at the University of Minnesota that disclosed that they had a financial incentive to keep the subject in the study for a year, a full year? Let me say, it's a lot easier for you to answer if you ask me a question, rather than ask other questions, etc. So kind of stay on the tack, it's a lot easier for me. Have you seen, since you've been at the University of Minnesota since '99, have you ever seen an informed consent form that disclosed when a company was paying by the visit? No. That is, they had a financial incentive to keep in the study week after week? MR. ALSOP: Now it's argumentative, assumes fact not in evidence. MS. AHMANN: Join.

20 21 22 23 24 25 question?

MR. HUTCHINSON: Join. MR. ALSOP: Go ahead. THE WITNESS: Could you repeat your first

MR. ALSOP: He said no to the first part of question your question, and then you added something. 169

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BY DR. BARDEN: Q Have you ever seen an informed consent form at the University of Minnesota that disclosed a financial conflict of interest, in that the investigator or the study or the university was paid by the visit? A Q A Q I think I just said no. Okay. Haven't seen that. Have you seen one where the speaking fees and honorariums and consulting fees of the PI were disclosed in the informed consent form? A No. If I could take a break now, biological break now, it would be helpful. DR. BARDEN: Absolutely. THE WITNESS: Thank you. (Brief recess taken.) BY DR. BARDEN: Q Doctor, we're still on what's been marked as Exhibit J. If you look at the bottom right corner, handwritten number 11. Do you see that? That's 8. A Q Okay. There you go.

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A Q

Thank you. If you look at the top third of the page, it says -- page number UM IRB 2789. You see where it says, "Finder's 170

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fees: Sponsors sometimes offer investigators incentives for recruiting subjects or conducting research on an investigational drug or device manufactured by the company. The incentive may be either a monetary fee or a donation of equipment or materials. These incentives are not permitted." Do you agree with that? Yes. Are you aware of any incentives given by AstraZeneca to the recruiters in this study? No. Have you seen any of the e-mails back and forth documenting the incentives given in this study? No. MS. AHMANN: Object to lack of foundation. He said he hasn't seen any. BY DR. BARDEN: Q Have you yourself ever received financial or other incentives for recruiting subjects, that is, paid per subject? MS. AHMANN: Object to lack of foundation. MR. ALSOP: Also irrelevant, but go ahead, Doctor. THE WITNESS: There is two parts to your question. If you could break it in half for me, then I could get started.

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

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That's correct.

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Q

Next let's look at page 14, bottom right, 14, UM IRB 2704. See at the bottom there it says, "When some or all of the subjects, such as children --

A Q A Q

I'm sorry, where --- prisoners --" right here (indicating). Where are we looking, when? "When some or all the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence, or for subjects found at international sites, additional safeguards have been included in the study and in the IRB review process, to protect the rights and welfare of these subjects." Is that your understanding of the University policy?

A Q

Yes, it is. Are you aware of any special safeguards that were included in the CAFE study for Dan because he was listed by his treating psychiatrist as lacking capacity?

A Q

No. Are you aware of any additional safeguards used for Dan because he was under court order, that is, a stayed commitment, to follow the treatment recommendations of his physician, who is also the PI in the CAFE study? Are 173

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you aware of any safeguards for him with regard to that? That's a yes-or-no question. Then if it's yes, we can go into detail. Okay. No, I'm not aware of any safeguards, in this

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instance. Okay. Look at the bottom of page No. 16. Move right along here. This is Bates No. UM IRB 2657. See just below the middle of the page, University of Minnesota Role, Authority, Independence of the IRB -I apologize, I don't know where that is. MR. ALSOP: I don't see where you are. BY DR. BARDEN: Q "The IRB is charged with ensuring that those individuals participating in research are not subject to undue or inappropriate risks, that participation remains voluntary, and that the conduct of research is upheld as a privilege." Is that your understanding of Minnesota's policy? Yes, it is. And so the word ensuring there, e-n-s-u-r-i-n-g, you would agree with that, right? Yes. You're not aware of any statements under oath by Minnesota IRB officials that would be quite contradictory to that, are you? 174

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A Q

No. Okay. Page 19 on the bottom right. This is UM IRB 1316. Very top of the page, "Subjects who are not able to give informed consent may enroll in the research only if they have a guardian who demonstrates the capacity and willingness to consent for the subject. The subject will then need to assent to participation." Is that your

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understanding, that's the policy at University of Minnesota? I'm sorry, I've gotten behind you. Could you point to what you were reading? Just the top part there (indicating). MR. ALSOP: Would you read the first two sentences you read? BY DR. BARDEN: Q Right at the top. "Subjects who are not able to give informed consent may enroll in the research only if they have a guardian who demonstrates the capacity and willingness to consent for the subject. The subject will then need to assent to participation." Is that your understanding of your policy? Yes. Okay. DR. BARDEN: Let's mark this as Exhibit K. MR. ALSOP: Which one is it, so I know what 175

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I can give her? DR. BARDEN: One on the front. Well, actually I've got a copy for her. MR. ALSOP: It's not one that's copied? DR. BARDEN: It should be. MR. ALSOP: Okay. This one (indicating)? DR. BARDEN: No. August 6, 2002. MR. ALSOP: It's not in this stack. I don't have that myself either. DR. BARDEN: Well, it should be in there

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somewhere. He took it and copied it, and this is one of the ones that he copied. MR. ALSOP: Was that the second batch? Did you pass out the second batch? DR. BARDEN: I haven't passed out anything. It might be in that stack right there (indicating). MS. AHMANN: I have a copy if you -MR. ALSOP: Is this the one? (Schulz Deposition Exhibit K marked for identification.) BY DR. BARDEN: Q So we're looking at what's been marked as Exhibit K. I draw your attention -- this is a letter of August 6, 2002, from Carol Siegel, assistant director IRB, to Timothy W. Olsen in ophthalmology. I'm just looking at 176

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the last paragraph on this first page, which is marked UM IRB 0324, the first sentence, "The IRB would like to stress that subjects who go through the consent process are considered enrolled participants and are counted toward the total number of subjects." Is that your understanding of the University's policy? I'm not aware of that being a policy. Okay. Has Dr. Olson ever claimed to you that people aren't enrolled until they start taking the medication, not when they go through informed consent? Let me make sure. Are we talking specifically -- which study or what situation are we talking about regarding that question?

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Q

Okay. It's true, is it not, that the University of Minnesota policy is once a person goes through the consent procedure, they are enrolled in the study? MR. ALSOP: That's repetitious and a misstatement of his last answer, but go ahead, Doctor. THE WITNESS: Once a person signs the informed consent, to the best of my understanding, they are now enrolled in the study.

BY DR. BARDEN: Q Thank you. And that is what the IRB letter says, correct? A Glad I agree with you. 177

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Q

Excellent. Have you ever heard Dr. Olson issue forth a theory to you that's quite different than that, that is, that people aren't enrolled until they start taking the medication?

A Q

No. I don't think I've ever heard him say that. Okay. Did Dr. Olson ever claim to you that he got social worker approval before enrolling, that is, getting consent for Dan to enter the CAFE study?

A

I'm sorry, I didn't quite follow. Could you ask the question again?

Q

Did Dr. Olson ever claim to you that he got Dan's social worker's approval before enrolling Dan in the CAFE study?

A Q A Q

Which social workers are we talking about? David Pettit, Dan's social worker, David Pettit? I don't know Mr. Pettit. I can't answer the question. Okay. Have you ever read any letters in which Dr. Olson

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claimed in writing that he got approval from Dan's social worker to enroll him in the study? No. Have you seen any documents indicating that David Pettit was not even assigned to Dan until after Dr. Olson had enrolled Dan in the study? No. Hypothetically, if the court had ordered Dan to obey his treatment team and social worker, and if Dr. Olson had 178

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enrolled Dan in the study by getting his informed consent, before David Pettit had even been assigned to be his social worker, and then if Dr. Olson had written to people that the consent was okay because he'd gotten approval from his social worker first, you put those things together, would you be concerned about that fact matter? MR. GROSS: Objection, lack of foundation, multiple. MR. ALSOP: It's a vague question. It misstates the fact of this case, argumentative, lacking in foundation. If you can answer that, go right ahead. THE WITNESS: As I recalled, your question began by saying hypothetically. BY DR. BARDEN: Q A Uh-huh. So hypothetically, I would be concerned on what you just described. And the concern would be that a patient's rights may have

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been violated? The concern would have been that the sequence of events doesn't match what the doctor described. So the doctor may be mistaken or lying or whatever. Something. All right. Page, go to page 3 of what's been marked as 179

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Exhibit K. This is the consent amendment for the CATIE study. Have you ever seen this document before? No, I have not. Were you aware that the U.S. Food and Drug Administration issued a warning about increased risk of hyperglycemia and diabetes in persons taking the atypical antipsychotic drugs? Yes. MS. AHMANN: Objection, foundation. THE WITNESS: The answer is yes. BY DR. BARDEN: Q Yes, and you were aware that clinical trials using these drugs then had to issue this consent amendment to warn research subjects of this new risk? That's the usual procedure, yes. Okay. Were you aware that this was not done in the CAFE study until almost a month after the CATIE study and after Dan died? I'm not quite following. If you could restate the question for me. Okay. So there is --

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Q

The CATIE study and the CAFE study involve atypicals, right?

A

Both do. 180

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Q

Right, and the FDA issued a warning about diabetes and hyperglycemia for these drugs, right?

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Correct. There was a reconsent that is a consent amendment. Uh-huh. That was done for the CATIE study. Okay. And there was one done for the CAFE study. All right. And the CATIE study was done much earlier. This is, here's where I'm losing you. If I can clarify. Yes. When you say the CATIE study was done a month earlier, meaning by Dr. Lieberman?

Q A Q

Well, we're on 3. Do you see this? Yeah. Do you see the date in the bottom left? What does that say, April?

A Q

It says April 5, 2004. Are you aware of when the CAFE study finally issued their similar reconsent amendment?

A

Well, the point of clarification I was trying to ask you --

Q A

That's a specific question. You had another question --

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Q A Q

Yeah. -- on the floor for me. We'll get back to it. As coinvestigator of the CAFE study, are you aware of the date the CAFE study issued its reconsent amendment?

A

Let me answer that. So my earlier question had to do with when you said the consent amendments of being issued, etc. So your question to me is, so I understand, that the overall principal investigators of the CAFE study took a month longer to get the consent amendment sent out to the sites? Is that what your question is?

Q

What my question is, is I'm showing you the date of the consent amendment for the CAFE study.

A

Okay. MR. ALSOP: No, it's the CATIE study, sir.

BY DR. BARDEN: Q A Q The CATIE study, April 5, 2004. Do you see that? Yes, I do. My question to you is a very specific one, and it requires a yes or no, first of all. Were you aware that the CAFE study also issued a consent amendment warning subjects about this increased risk of diabetes and hypoglycemia? Hyperglycemia. A Not specifically, I wasn't aware that that had been issued. 182

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Q

Okay. Did anyone ever come to you and say, you know,

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

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BY DR. BARDEN: Q A Did anyone ever come and state that to you? No, they did not. MR. GROSS: Objection, misstates evidence.

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MR. ALSOP: It's irrelevant. Go ahead. THE WITNESS: I've already answered it. MR. ALSOP: Yeah, that's fine.

Let's look at the next page, page 4. It's an e-mail. On the top it says March 15, 2004. Do you see that? Then down below it says, "Dear CAFE Investigators and Study Coordinators. Recently the FDA issued a new warning about the risks of hyperglycemia and diabetes in patients taking atypical antipsychotic agents, including the CAFE study medications." Do you see where it says that? Yes, I do. So they were on notice as of this March 15, 2004, correct? MR. ALSOP: Object on the basis of foundation, but go ahead. THE WITNESS: Okay. Again, the question is -- I'm sorry. I get distracted with the multiple conversation.

BY DR. BARDEN: Q The CAFE investigators, that would include you, correct, 184

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you are a coinvestigator? I am a coinvestigator. So you received notice of this also, correct? I probably did not receive this. I'm awfully sure I didn't. But Dr. Olson, who certainly as the investigator, would receive one?

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A Q

As principal investigator, he would have received this. All right, and it says, "Some sites were required to add this information earlier by their IRBs, but if your consent form does not contain information about diabetes, it is recommended that you add it." Do you see that?

A Q

Yes, I do. Look at page 6, bottom right, UM SPA 0437, University of Minnesota, attention payments, Quintiles, Inc. Was that the company that was doing the study, Quintiles?

A

I believe Quintiles is known as the CRO, a clinical research organization.

Q

It says -- and where does the money for Quintiles come from, to the best of your knowledge? MS. AHMANN: Object, lack of foundation.

BY DR. BARDEN: Q A It came from AstraZeneca, didn't it? To the best of my knowledge, when Quintiles oversees a study, they are paid by the study sponsor. So like for 185

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CATIE, the NIMH would. Right, and it says -- and for this one, AstraZeneca paid them, right? MS. AHMANN: Object, lack of foundation. THE WITNESS: Yeah, CAFE study, Quintiles. BY DR. BARDEN: Q A Yeah, AstraZeneca. Quintiles were in the study, AstraZeneca provided the money. Right. It says make check payable to University of

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Minnesota. Do you see that, upper right there, check payable to University of Minnesota? Yes. Reference or description, "Per Agreement Due Upon Initiation of Study." That means getting someone in the study as the subject, right? No. Oh, I see. Oh, I forgot. The contract said if they didn't get a subject in, then they had to refund this money, correct? I don't know that. MS. AHMANN: Object, lack of foundation. BY DR. BARDEN: Q You don't know that? You haven't seen a contract for the CAFE study? 186

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A Q

No. Well, it says that amount $16,362, and then it says, "Independent Review Board Fees." What's that for, do you know?

A Q

My understanding is that's the IRB fee. Okay, so the IRB was paid by AstraZeneca. MS. AHMANN: Objection, lack of foundation. THE WITNESS: By Quintiles. MR. GROSS: Same objection.

BY DR. BARDEN: Q Have you ever seen any statements under oath by an IRB official saying they're not paid by drug companies or outside companies?

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A Q

No. Interesting. Okay. Now let's go to page 8, bottom right corner, 8, UM CAFE 3191, the bottom of the page, "Recruitment Efforts?"

A Q

Where are -This is an e-mail to Jeannie Kenney. Have you seen that name before?

A Q A

Yes, I have. Who is Jeannie Kenney? What does she do? Jeannie Kenney was a project coordinator and social worker in the Department of Psychiatry.

Q

Was she paid for her work on the CAFE study? 187

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MR. GROSS: Objection, lack of foundation. THE WITNESS: I believe so.

Do you have any idea how much she was paid? I'm sorry, I take that back. I apologize. Jeannie Kenney was a member of the Department of Psychiatry, and she received a salary for her work. A portion of her salary came from the University of Minnesota Physicians for her work in clinic. She received a University check for her work on a variety of studies. So she did receive some funding that came from the CAFE study, correct? In fact, she's listed right on the study documents as receiving funds. MS. AHMANN: Same objection. THE WITNESS: I thought I answered the

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MR. ALSOP: You have.

Looking at page 3191, it says, "Recruitment Efforts: In an effort to assist you in your recruitment efforts, a monetary allowance is being made available to you to provide food and beverages at functions that serve as a forum to recruit subject for the CAFE study. Your site would be reimbursed up to $100 over each 3 month period. Quintiles will pay on behalf of AstraZeneca for 188

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reasonable costs upon review and receipt of an invoice." Was that your understanding of the policy? MR. ALSOP: Objection on the basis of foun -BY DR. BARDEN: Q Was this in recruitment? MR. ALSOP: Objection on the basis of foundation. MR. GROSS: Same objection. MS. AHMANN: Same objection. MR. ALSOP: It's also vague as to -- go ahead. BY DR. BARDEN: Q A Is that your understanding of the policy? What policy? MR. ALSOP: What policy? BY DR. BARDEN: Q A I'm not sure of the -I can certainly see that Quintiles wrote the letter, and

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it's not, in my experience, unusual for a company like Quintiles to provide support for investigators to meet with community groups to explain there is a study going on. Okay, so they would pay money on behalf of AstraZeneca for reasonable costs to assist them in their recruitment 189

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efforts, and it's your understanding that's not uncommon. That's correct. Okay. If you look at page 13, bottom right. This is UM CAFE 3006. From Danielle Simons at Quintiles. Did you ever get an e-mail from Danielle Simons? No. And under the CC list, you see where it says Stephen Olson? Okay. That's like at the middle page, Danielle Simons, Elizabeth Lemke. Stephen Olson was the PI for the CAFE study? Same group. Danielle, Elizabeth Lemke, Jeannie Kenney, and Steve Olson. I mean, it's to Ande somebody. I don't know who that is. Okay. So at the bottom, it talks about "Consent Versions 6-26-02." "Enclosed are a copy of the letter we're sending to the IRB with the consents, a copy of each of the two consents including the stipulations you'd suggested, and a copy of the letter we sent to the IRB along with a copy of our site approval letter. Next on the docket then is recruit, recruit, recruit!" Exclamation point. "This is so exciting--thank you so

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much for everything you've done so far to get us going!" So they were very interested in focusing on recruiting, correct? 190

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A Q A Q but go ahead. BY DR. BARDEN: Q

MR. ALSOP: Object as vague, also lacks foundations, but go ahead. MR. GROSS: Calls for speculation.

Is this common, that the companies are trying to pump people up to go out and recruit subjects for drug studies? MR. GROSS: Objection, misstates evidence. MR. ALSOP: Assumes facts not in evidence,

MS. AHMANN: Join. THE WITNESS: Let me just ask a question. I can see here -- I'm not sure who this memo is to. I can see who it's copied to, but I don't know who it's to. BY DR. BARDEN: Q Well, these are the UM CAFE study documents, so we have to -I'm sorry -This says, this is, "Hi Danielle," which would be Danielle Simons at Quintiles, and it's from Elise, who Elise is at the -- she's at the University of Minnesota, I'm told. But my question to you really didn't go to that. My question went to -And --- is this common, this kind of focus on recruiting, is

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

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recruit in order to be able to complete the projects that

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they've been approved and been provided funding for, and it includes industry-sponsored trials, especially in the area of registration of a medication and for studies such as this to try to find out what are the best treatments for the early stages of schizophrenia. BY DR. BARDEN: Q A Q Right, a lot of pressure to recruit. Yup. Because if you don't finish the study, you don't get to publish, right, Doctor? MR. ALSOP: That's a misstatement of his prior testimony. Wait, wait. And I -DR. BARDEN: You don't get to say the whole sentence. You can say misstates. MR. ALSOP: I had other objections, sir. I have interrupted you not once. DR. BARDEN: Make a legal objection. MR. ALSOP: I did. DR. BARDEN: Go ahead. MR. ALSOP: It's a misstatement of the evidence, it's argumentative, and it's vague. Go ahead. MS. AHMANN: Join. BY DR. BARDEN: Q And you testified earlier that maybe publishing isn't 193

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that important to some people's careers, right? Yes, I did. Okay. We'll show you your resume again, marked as Exhibit A. How many pages of your resume contain nothing

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but your publication list, Dr. Schulz? Well, actually -No, no. It's a numerical answer. MR. ALSOP: Go for it. THE WITNESS: I'm sorry. I didn't understand the question that way. BY DR. BARDEN: Q A How many pages of your resume contain your publications? So my publications start on the mid point of page 10, and they conclude on page 24, so that would be 14 out of 26 pages, a little more than half. Thank you. You can't publish a study unless you've completed it. Isn't that correct, Doctor? You have to write it up when it's done and you have results to publish. MR. ALSOP: It's now a multiple question, but go ahead, you can answer. THE WITNESS: It's just a general question? BY DR. BARDEN: Q Yeah. It's easier to publish a study that's been completed. 194

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A

Yes. MR. ALSOP: Is that a statement or question? Go ahead. DR. BARDEN: He answered it.

BY DR. BARDEN: Q Now, let's look at page 14, at the bottom right, of what's been marked as Exhibit --

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A Q

Just look here. You see here's an e-mail from Amy VandenEynden at Quintiles to Jeannie Kenney. Do you see that?

A Q

Yes, I do. And it says, "It sounds like you have a good amount of leads/potentials. Hopefully your hard work will start to pay off soon!" Exclamation point. "The specialty inpatient unit sounds like it will help out a lot with recruitment!!" Exclamation point, exclamation point. Did you set up that specialty inpatient unit to make it particularly easy to recruit psychotic patients? MR. ALSOP: It's a multiple question, it's vague, but go ahead. THE WITNESS: I talked with the administration at University of Minnesota Medical Center to indicate to them that I thought having a unit that specialized in the care of people with serious psychiatric illness would improve the quality of care to 195

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schizophrenic patients in the Twin Cities; and in addition to that, I discussed, when I made my original recommendations, that it would foster the academic goals of the medical school and our department. BY DR. BARDEN: Q You see down here it says, "Take care and try not to get too frustrated!" Trying to recruit can be frustrating sometimes. Isn't that right, Doctor? Yes. Okay. Let's look at the next e-mail. Bottom of 14.

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Again, this is -MR. ALSOP: What page number? DR. BARDEN: Fourteen, at the bottom there. It's UM CAFE 2959. MR. ALSOP: Okay. BY DR. BARDEN: Q It says Jeannie Kenney to Amy VanderEynden at Quintiles. It says in the e-mail, "The last young woman who was referred from inpatient would have benefitted so much from this study. I put in a lot of time, meeting with the case manager and attended the discharge planning meeting. I thought the parents were interested. I do have her scheduled with Dr. Olson for outpatient med management so perhaps we can gain their trust and offer it as an option again." 196

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Is this the kind of e-mail that goes back and forth between the drug company financing running the study and the people recruiting, to the best of your knowledge? MS. AHMANN: Objection, as to misstates who this is to and from, and also lack of foundation. DR. BARDEN: Back and forth? This is from Jeannie Kenney to Amy VandenEynden at Quintiles, right? MS. AHMANN: Yeah, but you said it was from the drug company. DR. BARDEN: I don't think I said drug

THE WITNESS: Yes, you did.

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MR. ALSOP: I think you did. DR. BARDEN: Okay. Excellent.

From the company paid by the drug company to conduct the study? MS. AHMANN: Lack of foundation.

So is this the kind of letter you see? MR. ALSOP: Objection as lacking in

Do they share information about patients and who they're 197

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trying to recruit and whether they've spoken to the parents? I haven't seen e-mails like this in my experience, no. Trying to gain their trust and -- okay. It says, "the hospital is opening a psychosis specialty inpatient unit first of April. Dr. Olson and I are very much involved in the planning so will have closer contact with first episode people who come in. We are really hoping to promote state-of-the-art care and potential for research is part of the programming. In fact, it will be discussed in the interviewing of staff so it will be nice to have a treatment team fully on board with what we are doing in the department." Have you ever seen that e-mail before today? No. Okay. Next, next, this is the e-mail back. "Hi--I can

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understand that you are frustrated!!" Exclamation point, exclamation point. "Do what you can with subject 002. Please call if the subject gets out of window, because there is always the possibility of granting exceptions. If I am not available, contact Jennifer Frantz. As for recruitment, have you had any luck with any of the area facilities? I thought you mentioned you'd go to area sites and give them information. Is there anything we can [do to] provide to help you with this? Amy." Have 198

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you ever seen this before today? No, I did not. Okay. Next e-mail, Jeannie Kenney to Amy VanderEynden, Quintiles. "Hi Amy. Having trouble with Subject 002. His sister just died, his father has terminal cancer and now the grandmother is sick. He missed a visit and now just missed the next one. I hope I can get him in for the allowable window for the visit he missed Friday. I understand the situation is really difficult but am afraid we might be losing him when his family thinks he probably needs this treatment now more than ever. Have had another person show interest from inpatient and then the parent put the pressure on and said," quote, "'NO,'" unquote. Paragraph, parentheses, "(3rd time this has happened)," close parentheses. "Have tried to ask about concerns, etc. but usually just get a NO. So, some frustration here because we really need to get more enrollees. We've had none for January and that concerns me a lot."

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Did you ever see that letter before today?

The date of that is January 27, 2003. "Parent put the pressure on and said, 'NO". (3rd time this has happened)." Does that help us understand why nobody listened to Mary Weiss? 199

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MR. ALSOP: You don't have to answer that question. There is no question. Just wait. Ask -BY DR. BARDEN: Q Based on your knowledge of the CAFE study and what's in this letter, does that help us understand why Dr. Olson ignored Mary Weiss's complaints about the study and complaints about her son's deteriorating mental health and warnings that he was going to commit suicide? MR. ALSOP: It's argumentative and a misstatement of the facts. Go ahead, Doctor. And lacking in foundation. If you have any idea, go ahead. MS. AHMANN: Same, join in the objection. THE WITNESS: I don't see the link between this e-mail and what I know of Dan's case. BY DR. BARDEN: Q Okay. Please look at page 18 on the bottom right. Again, this is from Jennifer I. Frantz at Quintiles, November 2002, to Jeannie Kenney. "Hi Jeannie, I made a blunder when I reviewed your consent and am really really sorry." Goes on to say, "My hope is that your IRB already caught it or that it has not been reviewed yet." I'm sorry, where are we now?

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Q A Q

We're just following right along here. I guess we kind of skipped this part? Yeah. I'm going to ask you questions about particular 200

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

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(Brief recess taken.) DR. BARDEN: We're back on the record?

Thank you. Show you what we're going to mark as Exhibit L. Done with this? Yes, done with that. (Schulz Deposition Exhibit L marked for identification.) MR. ALSOP: One page? DR. BARDEN: Uh-huh, one page. MS. PEARSON: I think there is a paper clip

This is from the financial records of CAFE study. It's UM SPA 0068, 'and Dr. Schulz, have you ever seen this document before? I don't believe so. Wait a minute. Yeah, we're going to look at that. At the top, you see where it says principal investigator, Dr. Stephen Olson? Yes, uh-huh. And it talks about the CAFE study, correct? Uh-huh. 202

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Q

And the total grant amount, what is that dollar amount?

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A Q A Q A Q

$327,057. And was that your understanding of the CAFE study amount? Well, I'm not surprised by that amount. And then under Stephen Olson, do you see that, M.D.? Yes. There is some dollar numbers there. Can you read those off for us?

A

Sure. So Dr. Stephen Olson is listed as eight percent. Right here at this highlight (indicating)?

Q A

Yeah, uh-huh. And then the top number is $7,220.76, and then it has some other periods with some changing percentages, so it's March 3rd through, March 3rd through 2004. I'm a little confused by that. I'm sorry. Anyway, $6,987.35. Then 3/4, that might be March of '04, to June of '04, is my speculation, $2,000. This is probably July '04 to September '04, $1,770; and September '04 to February '05, $2,509.76.

Q

So are those the amounts that AstraZeneca was reimbursing the University for Dr. Olson's time? MS. AHMANN: Objection, lack of foundation.

BY DR. BARDEN: Q Or how did that work? What's your particular understanding of that? 203

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A

Okay. So when a person receives word that they're going to get a grant, then they notify the sponsored projects section of the University. The University makes a contract, in this case it would have been with Quintiles,

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and they conclude that this is going to be the total amount for the grant if all the subjects described enter the study. Uh-huh. So if -- so that's what this number is. Okay, so if fewer -- if they don't get the number of subjects, the money goes down, correct? Correct. Now, I don't see Quintiles on there anywhere. What I see is this name of AstraZeneca Pharmaceuticals. Yeah, I see that too. Do you see that? Uh-huh. We don't see Quintiles anywhere on this form, do we? Yeah. So then if they don't recruit and they don't get the number of subjects, then money reimbursed goes down. That's correct, because less work was done. Right, and then you also see ten percent for you, Dr. Charles Schulz, correct? Yeah, and then -204

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Q A Q A Q

It says for effort only? Effort only. But you're listed as ten percent. Uh-huh. And in some other documents, it says ten percent for training and supervision. Isn't that right?

A

Uh-huh.

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Q

So did you tell the IRB and the companies that you were going to do this ten percent, and then you didn't do it; or how did that work?

A

I told Dr. Olson I was going to work on the study and assist him, and I was, I believe, assigned that I would be available up to ten percent time, but that I did not want to receive any money for whatever he might call upon me to do.

Q A Q

But apparently he never called on you. Correct. Then we have Jean Kenney, and then we have a listing of dollars for her. We won't go through all those, but it starts at 11,500 some dollars and goes on down from there. So this basically kind of outlines some of the funding that was involved in the CAFE study, correct?

A Q

Yes. Okay. DR. BARDEN: Next we'll mark this as 205

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Exhibit M. (Schulz Deposition Exhibit M marked for identification.) BY DR. BARDEN: Q A Q A Q It's a letter on AstraZeneca letterhead, correct? Yes. It looks like it's to Stephen Olson, M.D.? Yes. The University of Minnesota Department of Psychiatry. Signed by Savinder --

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A Q A

Can you go back just for a second? Uh-huh. It's interesting, as you're pointing this out to me, that it's addressed to Dr. Olson, who is the principal investigator, but the letter was sent to the Office of Sponsored Projects Administration.

Q A

Okay. So it would not have gone immediately to him. It would have gone over to --

Q A Q

Sure. -- what we call SPA. But it's signed by you, you recognize Dr. Olson's signature there, correct?

A Q

Correct. Yeah. 206

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A

I just thought I'd mention that it probably went through SPA, they looked at this, then brought it over, forwarded it to Dr. Olson.

Q

That's fine. And then we have a Sue Marshall signing for the Regents of the University of Minnesota?

A Q

Yes. And then we have Savinder Saini, Esquire, signing for AstraZeneca, it looks like, right?

A Q

Yes, that's what it looks like to me. And it says, this highlighted section in the middle there just says, "PER SUBJECT PAYMENT, $15,648." Did I read that right?

A

Yes.

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Q

Okay. Then on the next page, second part of the letter, it says, "AstraZeneca shall pay to Institution the Per Subject Payments according to the milestone payment set forth below: Completion of Visit 3: $4,452, completion of Visit 6: $1,482, completion of Visit 9: $2,352, completion of Visit 12," and so on, correct?

A Q

Yes. Then below that it says, "Compensation for subjects who do not complete the Study will be calculated on a prorated basis according to the following schedule," and there is a prorated basis for payments, correct?

A

That's what it looks like the document says, yes. 207

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Q

Okay, great. That's yours. All right. We'll show you what's marked as Exhibit N. MR. ALSOP: I guess we're going to mark the original. (Schulz Deposition Exhibit N marked for identification.)

BY DR. BARDEN: Q Okay. Doctor, I want to call your attention to -- all right. See at the top there where it says check date of 17 October 2005, right? A Q Yes. And it says, "Sponsor: AstraZeneca Pharmaceuticals, LP," correct? A Q Yes. Okay, and it says, "Site: Stephen Olson," has a number

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for him, correct? Yes. Okay, and at the bottom it says, "Regents of the University of Minnesota," and it's Quintiles, Wachovia Bank check for $30,622, correct? Yes. Okay. I'd like to call your attention to the patient visit about two-thirds of the way down, patient ID No. 13. Were you aware that's Dan Markingson's number? 208

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A Q

No. Okay, and then you see a visit ID was visit 19. Do you see that?

A Q A Q

Yes, I do. Do you see the date was May 8, 2004? I do see that. And do you see the payment was made for $1,446 on that day for that visit?

A Q A Q

For that line, I saw, yeah. For that visit? Uh-huh. Yeah. Does that date ring a bell to you? Are you familiar with any of the dates in this study?

A Q A Q A Q

No. Yeah. Dan Markingson was deceased on that day. Okay. Sorry. So he really didn't have a visit 19. Okay. But apparently Dr. Olson fell for it.

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MR. GROSS: Objection, lack of foundation. MR. ALSOP: It's argumentative, misstates -MS. AHMANN: Can I just, I'm going to lodge my objection, and she keeps telling me she doesn't hear me, but the reason is, can you just pause when people start objecting so she can get the objections down? 209

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Thanks. BY DR. BARDEN: Q All right. Do you have any explanation for this document other than what we've discussed so far? No. If Dr. Olson had billed for a date on which his patient was deceased, would you have a trouble with that? Certainly. DR. BARDEN: How are we coming on the Xeroxing? MR. ALSOP: I can go check, if you want me to check. DR. BARDEN: Yeah. Why don't we just take -MS. AHMANN: Use those ones you copied before, or are those not -DR. BARDEN: Oh, yes. Hopefully, well, hopefully we'll get to that. MS. AHMANN: Okay. DR. BARDEN: You mean these, the last packet? MS. AHMANN: Yeah, that's fine.

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MR. ALSOP: There is three or four things here to be copied. DR. BARDEN: Let's go ahead and do that. 210

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

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A Q

Yes, I do. Help me understand why, a week apart, that that would be like that. MR. ALSOP: Object on the basis of foundation, but go ahead.

BY DR. BARDEN: Q Why would the suggestion as to what to do if medication is missed be different week-to-week like that? MR. ALSOP: Foundation. If you know, go ahead. THE WITNESS: So thanks for giving me a few minutes to take a look at this form, and I can really only speculate that the difference in the two orders are related to, in the first document, it looks as if the patient is making a transition into the study; and so in Dr. Olson's judgment, he felt that adding the missed dose may be the best way to proceed. On the second sheet, which is a week later, it looks to me as if on the back he's discontinued the Risperdal, which was his original clinical medicine, and he's now on the CAFE-assigned medications. So for whatever reasons that I won't speculate about, Dr. Olson decided that he would change the order. BY DR. BARDEN: Q Okay. Let's go back to -- do we have this one? 212

1

DR. BARDEN: Does everyone have this one?

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

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"Success spotlight: Irving Belz, M.D., [and] Stephen Olson, M.D.--sites that have been successful with turning an under-performing site into a well-performing site present their strategies."

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Is it your understanding, Dr. Schulz, that the strategies they're talking about are recruitment strategies for getting subjects into the study, correct? MR. ALSOP: I object on the basis of foundation, but go ahead. THE WITNESS: I don't know what they were supposed to talk about. BY DR. BARDEN: Q Have you never been present for a recruitment study meeting, in a meeting to improve or recruitment strategies? For CAFE? Yeah. No. For other studies? Sure. Okay, so that's fairly common, that you'd have meetings to improve the recruitment strategies, correct? I'm trying to think specifically, but in general, I'll say sure. In addition to the 300,000 plus dollars we've talked 214

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about with the CAFE study, and in addition to the publications that might come from that, were there in fact a number of other potentially very lucrative research studies that could emanate or flow from successful recruitment in the CAFE study? MR. ALSOP: Object as vague and ambiguous, speculative, lacking in foundation. Go ahead.

8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 BY DR. BARDEN: Q

MS. AHMANN: Join. THE WITNESS: Well, there certainly were a lot of adjectives there, so let me just try my best to answer the question. Clearly, if a faculty member in a clinical department does well, meaning says I will recruit ten people and recruits ten people, the likelihood that they would be invited to be involved in further studies goes up compared to somebody who makes a commitment and doesn't fulfill it. BY DR. BARDEN: Q Wasn't it in fact there was potentially millions of dollars involved to the University of Minnesota in making darn sure that Dr. Olson got enough subjects into the CAFE study? Isn't that right? MR. ALSOP: Object as argumentative.

Looking down the road at all the studies that were related to it, for example? 215

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MR. ALSOP: Object as argumentative. Now we have multiple question, vague and ambiguous, lacking in foundation. Go ahead. MS. AHMANN: Join. THE WITNESS: I'm not aware of any studies related to the CAFE study. BY DR. BARDEN: Q Okay. Would you look at the next page, please. It says UM CAFE document 0708. At the top it says, "Below is a list of studies currently conducted at the University of

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Minnesota for which subjects participating in CAFE/CATIE are considered: No. 1, Diagnostic Assessment Core ... for studies in schizophrenia and related disorders. Principal investigator: Stephen Olson." Then next page, it says, page 2, "White Matter Abnormalities in Schizophrenia." No. 3, "Genomics and White Matter Abnormalities in Schizophrenia." No. 4, "High Field MRS of Brain Development and Schizophrenia." Next page, No. 5, "Spatio-temporal studies of sensory and cognitive cortical processing in schizophrenia." No. 6, "Brain Surface Morphology in childhood and Adolescent Onset Schizophrenia." Next page, No. 7, "Study --" I'm sorry, this says -- page 4 is the one we were just on? I'm looking at the numbers that are listed here. I'm 216

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sorry. Next page, No. 7. In the middle of the page. "A study of Prefrontal-Mediated Tasks in Children and Adolescents with Schizophrenia and their siblings." No. 8, "The Disregulation of Optimized Cognition in Schizophrenia." Does that help jog your memory that there were other studies that were related to success in recruiting people for the CAFE study? MR. ALSOP: That's a misstatement of this document and argumentative and lacking in foundation, but go ahead. BY DR. BARDEN:

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Q

That's a yes or no. MS. AHMANN: Join. MR. ALSOP: You can answer it any way you want to answer it, Doctor. THE WITNESS: Can you restate the question after all the conversation?

BY DR. BARDEN: Q A Q Were there studies at the University related to CAFE? These studies were not related to CAFE. Really. Even though it says that they're currently conducted for subjects participating would be considered. So if you had subjects in CAFE, they would be considered 217

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as subjects for these other studies, thus helping them to be completed, thus helping them to be fully funded, thus helping them to be published, leading to more money and more studies, correct? MR. ALSOP: That's a multiple question, argumentative, a misstatement of his prior testimony, and misstatement of this document. If you can answer that, Doctor, go ahead. THE WITNESS: I've not seen this document before, so I don't know where Stephen Olson was headed. But related to your comments that if there were many patients who were enrolled in CAFE, that then they would, they were enrolled in CAFE, or the other study, CATIE, when they were done with that study, then they could be considered for these studies. BY DR. BARDEN:

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Q A Q

Next page, UM CAFE 0721, bottom right. I'll say No. 7. Which number? Right bottom of 7 there. Letter from Jean Kenney. Do you see that? To Jody Robertson in North Carolina.

A Q

Yes. Okay. Last few sentences here, "We did receive the wonderful basket with the mugs and other goodies. Everything is wonderful and is much appreciated. Looking forward to receiving the chocolates, etc. to thank 218

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referral sources." Is that your understanding it's a common practice to send thank you gifts for referral sources? No, it's not my understanding. Have you ever done that in any of your studies? Yeah, I think I may have in the past. I have a recollection of, during the mid-'90s, of visiting a community mental health center and providing a luncheon for them for collaborating with us. How about mugs and other goodies? No, I don't think I've ever done that. I don't recall ever doing that. And you've never done the other for the last seven years. Is that correct? That's correct. Next page, page at the bottom right UM CAFE 0728, 8. Study from the CAFE, Jody Robertson, project manager. "Dear Study Coordinators & Principal Investigators. Within this box are the CAFE goodies that we have been

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discussing in our recent teleconferences. These are to be used as small tokens of appreciation for any referring clinicians. Within you will find: Individually wrapped CAFE M & M packets, CAFE Post It Notes, informational brochures on Schizophrenia from NAMI, CAFE pens. You may request additional items listed above by sending ... 219

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e-mailed request[s] to" Jody Robertson. "Please contact me with any questions or comments." Have you ever seen this letter before today? No. Were you aware that the CAFE study was giving CAFE goodies out? No. By the way, it says informational brochures on schizophrenia from NAMI. You've been affiliated with NAMI in the past, haven't you? I'm a member of NAMI. Have you ever done any work for them or consulting? Yes, I have. Do you know where the money for NAMI comes from, Dr. Schulz? My understanding was that the vast majority of the money for NAMI comes from donations of family members who have a family member with a mental illness. And who told you that? I don't recall. Do you recall ever seeing any printed documentation of the percentage of NAMI funds that come from drug

23 24 25 A Q

pharmaceutical companies? No. Have you seen any of that in the national media? 220

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A Q

No. Okay. Next page, 9 at the bottom right, UM CAFE 0767, from Jean Kenney. See right in the middle of the page, September 3, 2002. "Hi Jody, I'm from Dr. Stephen Olson's site at the University of Minnesota. I was not notified of the CAFE Coordinator Teleconference. I started here just as our site got up in June and we have definitely been struggling to get patients. None of the recruitment really started until after I got here and got trained in so hopefully the work I've been putting in the last few months will start to pay off." Have you ever seen that e-mail before today?

A Q

No, I haven't. Next page, UM CAFE 0792. In the middle there, quoting Jean Kenney. "Hello Dr. McEvoy. Subject DAD was hospitalized --"

A Q A Q

It's pronounced McEvoy. McEvoy. Thank you. You're welcome. "Subject DAD was hospitalized 4/3/04 after rapid decompensation. As this was a weekend, Dr. Olson was not aware until Monday a.m. He was given 5 milligrams Zyprexa on 4/3 and 4/4. It was discontinued on 4/5 by Dr. Olson and he was restarted on CAFE meds which he was initially refusing. An IM Geodon 20 milligrams PRN order

221

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

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A

I don't have any knowledge of that.

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Q

Okay. Next, UM CAFE 2354, next page, bottom. There you go. The top, it says date, Friday, 24th September 2004. "Joellen, I need your assistance in dealing with MW, the mother of our subject who continues to bother my staff regarding her son's records. She apparently doesn't believe she has obtained all the records even though we have given her everything we have, except the raw data files from the study." Have you seen this note before today?

A Q

Nope. The bottom paragraph, "I also heard from Dr. Schulz that the legal management of this case that has to do with the research study will not be handled by UMP, but by the University, since it is self-insured. Who should we be communicating with about this?" So did you have a discussion with Dr. Schulz about the legal management -- wait a minute. With Dr. Olson, about the legal management of the case?

A Q

Yes, I did. And you told him it would be handled by the University, since they're self-insured?

A Q A

That's not what I told him. Really. What did you tell him? Yes. What I told him was that, to my knowledge at that 223

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time, that the way our practice plan, our University was set up, that if there was an untoward event or if there was litigation regarding a research study, that the defense of that would be done by the University. If a

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person had an untoward event and litigation, and the person was in the clinic and not involved in research, that the defense would be done by University of Minnesota Physicians. So I was informed of that at some point probably in the summer of 2004, discussed that with Dr. Olson. This part about since it is self-insured, I didn't say anything to him about that. Okay, and at that point, Dr. Olson had not told you that he was the sole and only physician treating Dan Markingson above and beyond the research study, correct? Correct, that's right. Okay. On page 13 on the bottom right, UM CAFE 2356, to Jennifer Frantz from Jean Kenney? Where? Subject -- I'm sorry we're on right here (indicating). See where it says to Jennifer Frantz? Yes. Okay. At the bottom it says Jeannie Kenney. Subject, this is in regarding subject 13. Do you see the 13 on the end of that number? Yes, I do. 224

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Q A Q

That's Dan. Uh-huh. "I know this has been a nightmare for all of you...I forwarded your e-mail to Ruth Flynn who is an attorney working in our Risk office and have asked her to respond about what we need to do with mom now that she has the records. My instinct is that we need to tell her to stay

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away, but Ruth will call you. Joellen Johnson, Patient Relations." Have you seen this e-mail before today? No, I have not. Okay, on page 19, on the bottom right. On the bottom right, handwritten number 19. UM CAFE 2362. "Shirley Qual, Esquire, Director of Compliance, Risk Management and Regulatory Affairs. I spoke to Mr. Dunder after I received --" well, this is from Steve, Steve Olson? Okay. I'm sorry. Where are we? Right in the middle here (indicating). We're on Steve's note, not to Shirley. Steve Olson's note, Associate Professor of Psychiatry. "I spoke to Mr. Dunder after I received this message and he indicates he is the appropriate person to act as a buffer with MW. He needs to see all of the material that MW is requesting, and as you told me later today, she has only the clinical notes, not the 1000+ pages of the resource source documents which I thought we had sent 225

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her. You should send Mr. Dunder the stuff that MW already has a copy of and a sample of the other pages (maybe all the source docs for his last visit, for example) and email him the neurocog files. He then can decide if he wants to see all the research file before discussing that with Astra-Zeneca legal and Quintiles. Steve." Have you seen this e-mail before today? No, I have not. Okay. Next page, 20 on the bottom right. "Dear Ms. Siegel." From Steve Olson. "I have received your

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letter of June 22 requesting a response to the letter from the State ombudsman regarding the death of subject 13 in the CAFE study ... I need more time to prepare a response to the many issues raised and also would like to appear before the executive committee to address any additional questions that may arise. I request this to be postponed from today's meeting to the meeting on August 1, and confirm that I will attend that meeting. Please let me know where the meeting will be held." Did Dr. Olson consult you at all regarding the letter he wrote to the ombudsman's office? No, he didn't. Hypothetically, if a letter written by Dr. Olson contained demonstrably false, deceptive, and misleading important information, would you be concerned? 226

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MR. ALSOP: Object as assumes facts not in evidence, misstatement of the facts, and vague and ambiguous. Go ahead. MS. AHMANN: Join. THE WITNESS: If that were so, then I would be concerned. It was -MR. ALSOP: You answered the question. THE WITNESS: Just was wondering if we can take just a little -DR. BARDEN: Sure, you bet. THE WITNESS: -- biobreak. (Brief recess taken.) DR. BARDEN: Back on the record?

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BY DR. BARDEN: Q Looking at this stack, right? MR. ALSOP: I think we had marked a different one as Q. DR. BARDEN: That's fine. We can do that one. That's been marked as Exhibit Q. (Schulz Deposition Exhibit Q marked for identification.) BY DR. BARDEN: Q Doctor, if we can go quickly through Exhibit Q. You'll see the page numbers on the bottom right handwritten. I'll try to move you through it. 227

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A Q

Okay. On page 1, do you see where it says Quintiles, Inc., at the top?

A Q A Q A Q

Yes. "Request for investigator payment, IRB reimbursement?" Yes, I do. The amount is $1500. I see that. And in the middle of the page, it says, "Sponsor: AstraZeneca." Do you see that?

A Q A Q

Yes. And "Investigator: Stephen Olson?" Yeah. "Reason for payment: IRB REIMBURSEMENT." Is it your understanding that IRB's responsible -- the reimbursement is by IRB's for their work?

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A

I have seen payment to our IRB for other studies. No, so this doesn't surprise me.

Q

Next page, page 2, UM SPA 0236. "Principal Investigator/Program Director, Stephen C. Olson." Do you see that at the top?

A Q

Yes, I do. Looks like a grant, doesn't it? "Personal justifications, Olson, principal investigator, Dr. Olson-8% effort." Do you see that? 228

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A Q

Yes. Okay. "Will supervise the personnel activities of the CAFE project and take primary responsibility for assuring the training and supervision of the staff." That's what he did, right?

A Q A Q

Yes. Okay. Then do you see your name down -Yes, yes I do. "Schulz, Co-Investigator ... 10% effort." Quote, "Will assist in the training and supervision of the staff. Will work with the entire team to develop and implement recruitment and follow-up care of patients in the protocol." You did not do that, correct?

A Q

That's correct. Do you feel like when you agreed to do this, you had a contract with the IRB and the paying agencies to do this or not?

A

Well, I didn't receive any money, so I didn't feel I had a contract for payment, and my understanding was that I

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was to be available to Dr. Olson for these activities. But if IRB approved this and if the sponsor paid for it based on the supposition that experienced Dr. Schulz would be assisting and watching over Dr. Olson and assisting in the training and supervision and recruitment and follow-up care, and you in fact were not involved in 229

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those things, you don't feel like they were misled? MR. ALSOP: That's a multiple question, misstatement of the facts, and argumentative, but go ahead. Also foundation as to what they felt. Go ahead. THE WITNESS: So, no, I don't think I misled them, and my understanding with Dr. Olson was that I would be available to him to cover if he called upon me and needed help with training of the staff, I would be available to do that, and that was a large part of the rationale why I did not accept any portion of my salary to be paid from CAFE. BY DR. BARDEN: Q Isn't it particularly troubling, given that this lawsuit is mostly focused on failures of recruitment and follow-up care of patients, the two things that you were going to be involved in assisting with, but didn't? MR. ALSOP: Object as argumentative, form of the question, with the assumptions you've made, but go ahead, comments. Go ahead. THE WITNESS: I'm sorry again to ask you to ask me the question. BY DR. BARDEN:

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Q

You were supposed to help with implementing recruitment, right?

A

I have said that I was available to Dr. Olson to help. 230

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Q

Yeah. A lot of the allegations in this lawsuit involve improper recruitment, violations of informed consent, and coercion, correct? Those are the allegations, correct?

A Q

Those are the allegations. Okay, and also a failure to follow up a grossly psychotic patient and notice they were suicidal and get them proper treatment. That's another allegation, correct?

A Q

It is, but -- it is. And these were the two parts of the study that you were going to assist with, correct?

A

Uh-huh. As I've said before, I was available to Dr. Olson if he called upon me for help in these areas.

Q

That's not what it says in this document. Doesn't say that at all, does it?

A Q A Q A

No, it's not what it says in the document. It says "will assist," doesn't it? Yes, it does. But you didn't assist, did you? Correct. He did not call upon me to help him. DR. BARDEN: Move to strike the rest of the nonresponsive answer.

BY DR. BARDEN: Q Does it say will assist when Dr. Olson calls upon him? Does it say that? MR. ALSOP: Wait, wait, wait. Stop.

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

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Q

Yes.

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A Q A Q

1(b). Yeah. It says percent of salary, correct, eight percent? That's correct. Thank you. Next page, 4 at the bottom. "Principal Investigator: Stephen Olson, M.D." Do you see that?

A Q

Yes, I do. It says, "Breakdown of Payments, initial payment, $16,362," correct?

A Q

That's correct. It says, "Upon receipt and approval of all regulatory documents and this signed Clinical Study Agreement, AstraZeneca shall forward a payment of $16,362 to the representative noted below. This Initial Payment is a refundable, advance payment for the first patient enrolled and will be deducted from future Per Subject Payments. If Institution does not enroll at least 1 Subject into the Study within 8 weeks of the date of its receipt of the Study Drug, this Agreement may be immediately terminated by AstraZeneca, and Institution shall refund to AstraZeneca the $16,362 Initial Payment." Did I read that correctly?

A Q

Yes, you did. And that's your understanding of the agreement you had, correct, the CAFE study? 233

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A

Yes, it is. MS. AHMANN: Objection --

BY DR. BARDEN: Q Next, page 5 at the bottom right. We'll be looking at

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pages 5 through, 5 through 14 as the AstraZeneca clinical study agreement. Between -- if you see UM SPA 0076, page 5 at the bottom right? Yes, I do see that. At the top it says, "This CLINICAL STUDY AGREEMENT ... dated as of the last date of the signatures below, is by and among AstraZeneca Pharmaceuticals, LP, a Delaware limited partnership with offices at 1800 Concord Pike, Wilmington, Delaware ... ('AstraZeneca'), and The Regents of the University of Minnesota, a Minnesota corporation ('Institution') ... with Stephen Olson ... as ('Principal Investigator')." Is that your understanding of the parties to this agreement? Yes, it is. Okay. On the next page, page 6 at the bottom, UM SPA 0077. Right in the middle of the page, it says, "Principal investigator --" Would you give me the letter? Sorry. B, 5(b). Okay. "Principal investigator shall obtain the informed consent 234

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of each of the Subjects prior to any screening or participation in the Study and in accordance with Applicable Laws. An informed consent form that has been reviewed and approved by AstraZeneca shall be completed for each Subject." Did I read that correct? You read it correctly. Is that your understanding of the contract for the CAFE

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study? MS. AHMANN: Object, lack of foundation. THE WITNESS: I'm looking at this for the first time, so yes, it is my understanding of the contract. I kind of looked at the back to check and see if it was signed and who signed it. So it looks like the contract. BY DR. BARDEN: Q Okay. Page 11. See where it says, "Indemnification by AstraZeneca," do you see that clause? Yup. Have you had that in other contracts? I would respond in general that there is frequently some discussion of indemnification for the studies that the departments and the med school do with the district. Have you seen any mutual indemnification agreements in this case? I haven't, no. 235

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Q

Okay. This one says that AstraZeneca will defend, indemnify and hold harmless for damages caused by the administration of the study drug. Were you aware that when Dan Markingson died, he had no drug in his bloodstream, no Seroquel? MR. ALSOP: Doctor, from other sources other than me, you can answer the question. Anything from what you learned from me, don't respond to. If you learned about that issue from other sources, go ahead and answer. THE WITNESS: No, I was not aware of that,

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other than from -MR. ALSOP: That's it. BY DR. BARDEN: Q Would it surprise you if I told you that the blood test taken at autopsy showed zero Seroquel in Dan Markingson's bloodstream? MR. ALSOP: That's irrelevant, lacking foundation, but go ahead. THE WITNESS: So the question is that -BY DR. BARDEN: Q Would that surprise you, since 82 percent of people discontinue taking Seroquel, is that surprising that he had no Seroquel in his bloodstream? I'm sorry, I was attempting to answer your first question. So the question, as I heard it, was whether I 236

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was surprised that there was no Seroquel in his bloodstream. Uh-huh. And without knowing the sensitivity of the assay used or, you know, how long after he died the postmortem was done and the blood sample was collected, when his last dose was before he died, I would have to say it is surprising in some ways, but without that information, I can't make a determination or an assessment. DR. BARDEN: Let's go to the next one, which is -- let's start with this one. See where it says, "Thanks for sending that info." MR. ALSOP: Okay.

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DR. BARDEN: UM CAFE 0565. (Schulz Deposition Exhibit R marked for identification.)

Let's look at page 1, Doctor, on the front there. It says, second sentence, "Regarding the proposed thank you gift, Tina Olexy at AZ." That would be AstraZeneca, correct? I believe so. "Has agreed to reimburse your site for the full $400 cost of the booth." Did drug companies reimburse you for booths at meetings in your previous studies? 237

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A

I haven't personally used booths at meetings, but Dr. Olson and his clinical research group working with patients with serious psychiatric illnesses would on occasion create a booth that described the research opportunities for people, give them information about what was going on at the University, and so that's what I speculate this is about.

Q

Okay, and it goes on to say, "As for the CAFE brochures, M&Ms, pens and Post It Notes, I'm glad you were able to track those down, even if it was a wild goose chase." Have you seen this e-mail before today?

A Q

No. Next e-mail to Jean Kenney from Jody Robertson, et al. Just we're on the same page. It says, in the middle it says, "Elizabeth and I made an executive decision about what we would like as a Thank You for the recruitment

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presentation. To offset the cost of our booth and to buy chocolates to attract folks to us we'd like to ask for a monetary gift. Not knowing exactly what is reasonable we are throwing out $200.00. Our booth costs about $400 and we spent about $80.00 on candy last year. Any idea when we might receive the brochures and other CAFE items (pens, post-it's, etc.)? We did receive our sweatshirts today. Thanks so much. They are really nice. Thanks for your support with this. We hope it brings a lot of 238

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referrals." Have you ever had study sweatshirts before? You know, I don't recall ever handing out study sweatshirts, but I have heard about other studies in which T-shirts about the study or something like that have been given to patients. Next page, page 2, to Amy from Jeannie Kenney. "Hi Amy. Attached you'll find the most recent ICFs. The IRB really got mixed up with approving the protocol change and so it wasn't until actually just this last week that we received final approval. They approved the consents before approving the protocol. I now need to go back and have everyone else sign new consents so they are officially informed of the protocol change." Have you seen this e-mail before today? No, I haven't. Next page. Did you ever pay for private limousines for patients to come in to be subjects in your study? Did you ever pay for private limousines?

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A

We paid for, there was a car service that provided more reliable pickup of some of our patients at agencies around town, so I was aware of a car company. I didn't know it was a limousine company.

Q A

Okay. Page, we're on page 3 here. Uh-huh. 239

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Q

Bottom of the page, again, Jeannie Kenney and Jennifer Frantz. "Depending on the mileage it would be between $30 [and] $50. One of [the] other studies is using this service. It was more cost efficient than cab fare and it's more comfortable as the [patients] are picked up in pretty nice vehicles. [It] kind of makes them feel important. Jeannie." Have you ever seen that e-mail before today?

A Q

No, I haven't. Okay. Next, page 4, letter April 25, 2003, from Jeannie Kenney to Quintiles. "Please find enclosed a receipt for refreshments. Our CAFE team presented information about the study at a private psychiatric outpatient clinic in the area." Have you ever seen this letter before today?

A Q

No, I haven't. Next page. From Jeannie Kenney to Monica Pallett. Who is that? Do you know where she is?

A

No. It sort of looks like she's at the University of North Carolina.

Q

Okay. With regard to the "CAFE PANSS Rater Certification Status." E-mail says, "Hi, I went back and saw that in September of last year," that would have been '03,

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September of '03, "Dr. Olson was reminded he was only certified for CATIE PANSS, not CAFE and that he would need to view the vignettes online. [It] looks like he 240

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

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A Q

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

A Q

No, I have not. Does this give us some idea of the kind of pressure, 242

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intense pressure on people to enroll subjects in the CAFE

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study? MR. ALSOP: Object as argumentative, misstatement of the document, lacking in foundation. Go ahead. MS. AHMANN: Join. DR. BARDEN: Strike that. I'll ask more specific questions. BY DR. BARDEN: Q Does it say in the letter they have worked on CAFE for almost two years? That's what the letter says. Research studies can take a lot of time and effort, can't they, Doctor? Yes, they can. Does this say there are only 13 weeks left to enroll subjects with no possibility of further extending the enrollment period? Yeah. That came about two-thirds of the way down, that's what the sentence says. So there are deadlines in some of these studies, aren't there? Yes, there are. And the deadlines involve a loss of funding, isn't that right, potentially a loss of funding, as we've seen in 243

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the other contract? Isn't that right? Well, I can't say what the implications for Dr. Lieberman would be vis-a-vis funding. Okay. So go to this one. It says, "Coordinator call

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minutes" at the top. MR. ALSOP: What does it say on the top? I missed that. DR. BARDEN: "Coordinator call minutes." If not, we'll just go through it quickly. MR. ALSOP: Let me see what it says. DR. BARDEN: "Coordinator call minutes." MR. ALSOP: There it is. Okay. (Schulz Deposition Exhibit S marked for identification.) BY DR. BARDEN: Q Page 1, in the middle there it says question. "Can we enroll a patient who has [four to five] months of previous treatment?" I'm sorry, where are we now? Right here (indicating). Four to five months of previous treatment. "Yes, but document it and send Joe McEvoy notification." Uh-huh. I'm sorry for this. Just orient me to the document a little bit. This is UM CAFE document 0422. 244

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A Q A Q

And it is, it says, "Coordinator call minutes?" That's what it looks like, uh-huh. Okay. I'm asking you a specific question about this statement in here that they can enroll a patient with four to five months of previous treatment. What was your understanding of the CAFE protocol with regard to

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previous treatment? How long could someone be in treatment previously before they weren't enrolled? My recollection of presentation of the study is that I believe it was about 12 weeks of antipsychotic medication treatment. Okay, and how long could someone have been psychotic before they could be enrolled in the study? I can't remember exactly, but my speculation is about two years. And that's what it says in the protocol, to the best of your knowledge. To the best of my knowledge. Okay. See in the bottom of page 1, it says, "Advertise in free" newspapers, "free papers. Directing the ads to both doctors and potential patients. Stress the high quality care that patients will receive as a perk to any referral." Have you seen that before today? No, I have not. 245

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Q A Q

Did you ever recruit any subjects for the CAFE study? I don't believe so. Have you ever stressed to a potential subject that they would receive perks for -- well, have you ever told any referring physicians that as a perk, they would receive high-quality care? MR. ALSOP: Object as vague, but go ahead. THE WITNESS: Over my career in clinical research, I'm sure I've discussed with my colleagues that my belief was that participation in some trials would

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lead to an excellent evaluation, sustained attention, perhaps some of the laboratory tests or imaging leading to discovery of other illnesses that they hadn't been screened for, and that it could be a useful thing for a patient to participate in clinical research, so -BY DR. BARDEN: Q A Q Sure. I've said that. Sure. If the study is competently done, it can be quite helpful, correct? Yes. The study's incompetently done, it can be quite harmful, correct? MR. ALSOP: It's argumentative, vague and ambiguous. Go ahead. 246

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THE WITNESS: Yes.

Let's look at page 4, middle there to Jody Robertson from Jeannie Kenney. "Thank you all very much for your generosity. I really hope we can give a report that we're getting 50 CAFE referrals out of this. Gotta think positively. I will get the invoice together and forward [it] to Marie asap." Have you seen this note before today? No. I'm sorry. I just wanted to kind of like get caught up here. So this is to Jody, as well as Jennifer Frantz and Christina Olexy, or something like that, copied to Elizabeth Lemke.

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Q A

And Lemke was on the study too, correct? Yes, she was. The subject is "Jody's address?" And it's from Jeannie.

Q A Q A

Uh-huh. Okay. She wants -Tell me again what the question is. I just want to make sure I understood what we're talking about.

Q

Yeah. She says, quote, "Thank you all very much for your generosity. I really hope we can give a report that we're getting 50 CAFE referrals out of this. Gotta think positively. I will get the invoice together and forward 247

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[it] to Marie asap." The question is, have you seen that before today? No. DR. BARDEN: Next let's look at this one. It says CAFE on the top. (Schulz Deposition Exhibit T marked for identification.) BY DR. BARDEN: Q See at page No. 1 where it says, "Recruitment information, new ideas [and] requests?" Do you see that? We're on the same page? No. 2? Yeah. My question, it says, "CAFE Coordinator Teleconference." Did you ever participate in any of these? I don't think so, no.

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Q

Next page, No. 2, these are the minutes of the October 2003 meeting, you see that, handwritten notes?

A Q

Uh-huh. Do you know whose notes these are? I don't, unless it says it on here. It says, "CAFE Teleconference: Coordinators. Last month: 27 enrolled ... October so far: 12 enrolled ... CAFE web cast meeting October 29th." This is during that time period, was it not, when Dr. Lieberman had wrote that they felt like their 248

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time was running out, they were under some considerable time pressure to recruit subjects, correct? Looks like it's a little more than two months before Dr. Lieberman's note. Okay. Same -- it was fall of 2003. This is dated fall of 2003. Right. Next page, 3, "CAFE Study Coordinator Teleconference, August 14th, Recruitment Report." Now, under Roman numeral II under recruitment report, it says, "Inpatient/Outpatient Recruitment. Newly added 16-bed psychosis-specialty unit." When did that unit open? You know, I can't remember exactly. My estimate is maybe in the spring of 2003, or sometime in 2002. Uh-huh. It says, "All nurses, case managers and staff are educated, aware and supportive of research. All patients are reviewed for possible research candidacy. Research staff are in contact with nurses, case managers, and attending psychiatrists daily." Were the patients informed that their nature

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of their illness and their problems might be reviewed by a research staff outside the treatment staff? My recollection is, yes, they were, and that there was a form developed, along with approval by the hospital, that would go on the front of the chart so that the attending psychiatrist could look at that and then sit and discuss 249

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with the patient the options for clinical research. Okay, so it's your testimony that there is a form signed in the patient's medical records where they know research people will be reviewing their files? I didn't say that. Okay. What I did say is, to my recollection of this era, that the hospital worked with some of the faculty to develop a form that went in the front of the chart to alert the attending psychiatrist of the potential for a patient to participate in research. If the psychiatrist, the attending psychiatrist, then looked at this form and went and talked to the patient about it and they, and then decided to refer, then the patient could be approached for the study. If the psychiatrist felt that he did not want his patient in the study, then the patient was not referred. Uh-huh. But doesn't it seem like Jean Kenney knows facts and particular details about these people that she's e-mailing around and they're still potential subjects who haven't written any consent forms? MR. ALSOP: I'll object as vague and

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ambiguous, form of the question. THE WITNESS: I'm sorry, I'm not following.

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

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

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Well, I'm pretty sure that they talked to the patient

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

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BY DR. BARDEN: Q That they're being quote, screened, unquote, "for multiple studies including CAFE?" MR. ALSOP: Same objection, it's foundation,

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but go ahead if you know. THE WITNESS: Okay. Well, I think this is Dr. Perkins, who works at University of North Carolina-Chapel Hill, giving her opinion, and I told you what our process was, and it looks like it's a little different than the one she's recommending. BY DR. BARDEN: Q Yeah, because this says if a potential patient is identified by the screening, "the recruiter should notify the study clinician who can [then] contact the patient directly." That's not talking to the patient; that's screening. Patient doesn't know. Yeah, I see that last sentence. I agree with you. "Strategy 2-Hold educational seminars on Schizophrenia and the CAFE study. Some suggestions for target groups are the ER and walk-in clinic residents and attendings. This is an opportunity to meet these people and establish a rapport while educating them on CAFE. (Remember, that AZ offers $100 [every] 3 months to support these events." "Strategy 3-During these educational meetings, emphasize the benefits of your site taking on 254

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the care of these patients. Some of these benefits are: 1. the ability to offer the patient immediate care, saving these portals' staff time and effort; 2. assure them that if the patient is not eligible, he or she will be referred to a physician, and if the patient is eligible, he or she will receive outstanding care and free medication."

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Were you aware that Dan Markingson had health insurance? No. Dr. Olson never mentioned that to you? Nope, he did not. He didn't? Are you aware that a person who is committed and under a stay of commitment, their health insurance has to pay for the treatment that's recommended? I wasn't aware that that was a routine. I knew that that happened sometimes. Were you aware that Dan Markingson was never informed of that? No. And it's certainly not on the informed consent form, is it, that he could have left, gone, and had a totally different treater paid for by his insurance by law? MR. ALSOP: Objection on the basis of foundation, but go ahead. 255

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THE WITNESS: Make sure I understand the question. You're saying was I aware, do I know whether Dan was ever told that or not? BY DR. BARDEN: Q That's an alternative treatment, isn't it? He could go out and get -- he could have had multiple atypicals at the same time. Can't have that on the study. He could have had Depakote. Can't have that on the study. He could have had a number of things. He could have gone to The Mayo Clinic. His insurance had to pay for it.

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Nobody told him that. It's not on the informed consent form, correct? MR. GROSS: Objection, multiple. MR. ALSOP: Form of the question, it's multiple. MS. AHMANN: Join. THE WITNESS: I don't believe -- I don't know what he was told about that. BY DR. BARDEN: Q Page 5. Bottom here, it says, "To thank you for your efforts, AstraZeneca is offering to provide a gift to each of your sites. This gift can be anything within reason (gift basket, educational materials/supplies, monetary support for any educational seminars you are giving (beyond the current allotment of $100 [every] 3 256

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months), etc.) If there are any upcoming seminars/training sessions you are interested in attending, we would also consider picking up those costs within reason. Please think about this offer, and in what way we can best support you, and let me know. We are open to all ideas, and will consider them all." Did you see this e-mail before today? No, I haven't. Did you ever receive a gift from AstraZeneca during your work with them? MR. ALSOP: It's vague. DR. BARDEN: Vague as to gift? Have you ever received a gift from AstraZeneca.

14 15 16 17 18 19 20 21 22 23 24 25 ever a gift? BY DR. BARDEN: Q A Q A Q A Q A Q Ever. Ever, yes.

MR. ALSOP: No. For the CAFE study or for

Have you received one for the CAFE study? No. You received one for something else? What was the gift? I received a pen from -Have you received a gift for recruiting subjects? No. Have you received a gift for a referral? 257

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A Q

No. Were you aware that they were giving gifts to encourage referrals? MR. ALSOP: It's repetitious. Go ahead. THE WITNESS: Well, I may not be understanding this correctly, but my understanding of how this was going is that Jeannie and Elizabeth, or Jeannie and Elizabeth and Steve Olson, would go to a mental health center or some other maybe community education meeting, and they would set up a booth, and they might have a bowl of chocolates or a pen with either University of Minnesota and, it sounds like from here, maybe the CAFE study, and that they would see that and talk either with people in the community or others. That's my understanding of what these materials were about.

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BY DR. BARDEN: Q Let's go to page 7. "Dear CAFE Investigators, Despite the fact we've made considerable progress in the period since the CAFE investigators' meeting in January [of] 2002, for a variety of reasons we are behind schedule on enrollment." A Q Do you know when this was written? I don't. It says January 2002, though. "For this reason I am requesting --" 258

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A Q A Q

It says since the meeting. Yup, that's right. Like we don't know when that -This is a document from the University of Minnesota. I can't add to it or subtract. "For this reason I am requesting that all site investigators and coordinators make every effort to attend the regularly scheduled teleconferences held monthly or bimonthly and particularly the ones this week. The topics discussed will be important in determining the future progress of the study." So was there, to the best of your knowledge, was there a great deal of concern and pressure that they were not recruiting enough people for the CAFE study? MR. ALSOP: It's vague and ambiguous, it's also repetitious, but go ahead. MS. AHMANN: Join, lack of foundation also. THE WITNESS: When I read this letter, it looks like Dr. Jeffrey Lieberman was very concerned about

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the viability of this study. DR. BARDEN: Let's look at this one. Monica Pallett on the top upper left, it's UM CAFE 0686, and we'll mark it as Exhibit -(Schulz Deposition Exhibit U marked for identification.) 259

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BY DR. BARDEN: Q Looking at the front part here, again, this is from Monica Pallett to Jeannie Kenney, November 7, 2003. Again, this is about checking on the PANSS certification of Dr. Olson. "He is not certified to rate the PANSS for CAFE and if he is doing so should score all three of the certification tapes ... Also, I just scored his PANSS submission for tape 20 for CATIE ... and he scored it quite low so [he] will need to rescore it." Do they have people rescoring tapes as part of research studies? If the people at the main office think the score's too low, they just have them rescore it? Is that research protocol? MR. ALSOP: It's a misstatement of this document, argumentative, lacking in foundation. Go ahead. MS. AHMANN: Join. THE WITNESS: So I don't know anything specific about this. BY DR. BARDEN: Q A Have you ever seen this e-mail before today? No.

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Q

Would you think it would be appropriate for someone to rescore a PANSS submission because a bureaucrat thinks it's too low? 260

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

261

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

1

A

That's correct.

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Q

Dr. Olson ever tell you that Dan Markingson kept a detailed journal?

A Q

No. That it was right there in his room in the Theo House, anybody could have looked at it any time or asked him what was in it, but apparently no one ever did? Did Dr. Olson ever tell you anything about this?

A Q

No, he did not. All right. Takes care of that one. DR. BARDEN: How much time have I used so far? VIDEO TECHNICIAN: As far as the videotape running? DR. BARDEN: Yes. VIDEO TECHNICIAN: We're about five and-a-half hours, give or take five minutes. DR. BARDEN: Okay, and you know what, we're getting into a whole other one, so I promised you 5:00 o'clock. We'll come back and finish the other two and-a-half hours, or whatever I have. MR. ALSOP: I think one and-a-half. DR. BARDEN: One and-a-half. Thanks. MR. ALSOP: Go right ahead. VIDEO TECHNICIAN: I can get the exact time 263

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for you. MR. ALSOP: Yeah, just give us a time so we can put in the record. DR. BARDEN: Thank you. We'll leave the

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exhibits with the court reporter and you'll make copies, correct, when you do this? And Doctor, we'll see you next time, and you'll make your dinner. MR. ALSOP: Do you want me to give the ones you have not? (Brief time off the record.) MR. ALSOP: Mr. Barden, I'm just going to put on the record that he confirmed it's five and-a-half hours. VIDEO TECHNICIAN: Give or take five minutes. MR. ALSOP: That's fine. So five and-a-half hours.

(Deposition adjourned at 4:45 p.m.) * * * *

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STATE OF MINNESOTA COUNTY OF WASHINGTON

) )ss. )

CERTIFICATE

BE IT KNOWN that I, Janice L. Young, took the foregoing deposition of CHARLES SCHULZ, M.D.; That I was then and there a Notary Public in and for the County of Washington and State of Minnesota; That by virtue thereof, I was then and there authorized to administer an oath; That the witness, before testifying, was by me

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first duly sworn to testify the truth, the whole truth and nothing but the truth relative to said cause; That the testimony of said witness was recorded in stenotypy by me and was reduced to typewriting under my direction; That the foregoing deposition is a true record of the testimony given by said witness; That the cost of the original has been charged to the party who noticed the deposition, and that all parties who ordered copies have been charged at the same rate for such copies; That I am not related to any of the parties hereto, nor an employee of any of them, nor interested in the outcome of the action; That I am not financially interested in the action and have no contract with the parties, attorneys, or persons with an interest in the action that affects or has a substantial tendency to affect my impartiality; and That the reading and signing of the foregoing deposition by said witness were waived. WITNESS MY HAND AND SEAL this 30th day of June, 2007. ______________________________ Janice L. Young

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