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University of Minnesota Mail - Several Media Items https://mail .google.com/mail/u/0/?ui=2 ik=28 lfa64bb4 view..
V
Brian Steeves
Several Media Items
BranSteeves Wed Nov14 2012at 301PM
To: Linda Cohen David Larson
Cc: Eric Kaler Amy Phenix mark rotenberg
Bcc: Clyde Alien David McMillan Dean J ohnson
J ohn Frobenius Laura Brod Maureen
Ramirez Patricia Simmons Richard Beeson
Tom Devine Venora Hung Angela Menzel
Ken Savary Mary Swords Pamela Hudson
Sarah Dirksen
T O : A L L RE GE N T S
I am writing to provide a heads up on several items that have or may generate media attention.
Defibrillator Research
Professor Frank Bates, head of Chemical Engineering, published a study yesterday in the journal
Macromolecules that highlights significant issues with St. J ude defibrillators. The study includes clear
language that identifies Bates as a paid consultant to Medtronic, and it is my understanding that the research
was funded by Medtronic. Like all published research, this study was peer-reviewed. The study has already
received some attention in Business Week (http://www.businessweek.com/ap/2012-11-13/analyst-study-
shows-new-st-dot-jude-wire-problems) and may also generate local attention since both companies are
located in Minnesota.
Social Worker Sanctioned
Several media outlets (including the Star Tribune: http://www.startribune.com/local/179042061.htm?refer=y)
have reported on a Corrective Action agreement between former D of M social worker J ean Kenney and the
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University of Minnesota Mail - Several Media Items https://mail .google.com/mail/u/0/?ui=2 ik=281fa64bb4 vievv..
Two years ago, the University of Minnesota Medical School launched the Preparation for Residency Program
(PRP) to train immgrant physicians and get them on a track to practice medicine in the United States. After
some initial success, the landscape and prospects for the program have changed. Therefore, the Medical
School has suspended the PRP program as it looks for new ways to leverage the talents of these physicians.
A fact sheet on the evolution of this program is attached.
Please let me know if you have any questions on these items.
Brian R. Steeves
Executive Director & Corporate Secretary
Board of Regents
University of Minnesota
612-625-6300
PRP Fact Sheet.pdf
8 K
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University qf Minnesota Mail - Updates https://mail.google.com/mail/u/0/?ui=2 ik=281fa64bb4 view..
A
Brian Steeves
Updates
BranSteeves Tue Dec3 2013at 239PM
To: Richard Beeson Dean J ohnson
Cc: Eric Kaler Amy Phenix
Bcc: Abdul Omari Clyde Alien David Larson
David McMillan J ohn Frobenius Laura Brad
Linda Cohen Patricia Simmons Peggy Lucas
Tom Devine Ken Savary Mary Swords
Pamela Hudson Sarah Dirksen Stephanie
Austin
TO: ALL REGEN TS
K ALER INV ITED TO WH I TE H OUSE
President Kaler has been invited to the White House next Wednesday for a day-long summit dedicated to
launching a plan of action for increasing college access and success for low-income and disadvantaged
students. The event is being jointly coordinated by the National Economic Council, the Domestic Policy
Council, and the Department of Education.
SENATE HEAR ING ON CAMPU S SAFETY
The Senate Higher Education & Workforce Development Committee will hold a hearing on metro campus
safety on Tuesday, 12/10. VP Wheelock and UMPD Chief Hestness are scheduled to appear. (Details can be
found here: https://www.senate.mn/schedule/schedule.php?ls=&type=upcoming&cmte_id=3072&
cmte_type=standing).
U N I V E R SI T Y S E N A T E T O D E B A T E H U M A N S U B J E C T S RE S E A RC H R E SO L U T I O N
Several faculty members have continued to express concern about the circumstances surrounding the 2004
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Unnjeteity gf Minnesota Mail - Updates https://mail.google.com/mail/u/0/?ui=2 ik=281fa64bb4 vievv..
Brian R. Steeves
Executive Director & Corporate Secretary
Board of Regents
University of Minnesota
612-625-6300
BOR resp to Elliott et al re Markingson.pdf
638K
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University of Minnesota Mail - Markingson Case https://mail.google.com/mail/u/0/?ui=2&ik=281fa64bb4&vievv..
A
Brian Steeves
Markingson Case
BranSteeves Tue Apr 29 2014at 511PM
To: Richard Beeson Dean J ohnson
Cc: Eric Kaler Amy Phenix William Donohue
Bcc: Abdul Omari Clyde Alien David Larson
David McMillan J ohn Frobenius Laura Brod
Linda Cohen Patricia Simmons Peggy Lucas
Tom Devine J ason Langworthy Mary
Swords Pamela Hudson Sarah Dirksen
Stephanie Austin
T O : A L L R E G E N T S
As you know, a small number of individuals continue to express concern about the circumstances surrounding
the 2004 suicide of Dan Markingson while he was enrolled in a clinical drug trial at the University of
Minnesota. Several independent investigations and reviews have been conducted (see attached summary)
and in February 2011 then-Chair Clyde Alien sent a letter on behalf of the Board stating we do not believe
further University resources should be expended re-reviewing a matter such as this, which has already
received such exhaustive analysis by independent authoritative bodies. (See complete copy of Alien letter
attached.)
On 12/5/13 the University Senate passed a resolution seeking an external review of the University's human
subjects research policies, practices and oversight. An RFP for that review has been issued.
Recently, individuals from inside and outside the University have attempted to escalate this matter by
contacting prominent community leaders and University donors. We have also been informed that a peaceful
protest/vigil is being planned outside McNamara Alumni Center in conjunction with the upcomng Board of
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University of Minnesota Mail - Markingson Case https://mail.google.com/mail/u/0/?ui=2&ik=281fa64bb4&vievv..
Dan Markingson Investigations and Reports Updated 4-22.pdf
56K
BOR resp to Elliott et al re Markingson-3-pdf
1638K
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Dan Markingson Case
Reviews, J udgments and Investigations
In the ten years since the death of Daniel Markingson (DRM), there have been multiple
investigations and rulings about the case, the care that he received, and the University's
policies for the protection of human subjects in clinical research.
None of the investigations found evidence of misconduct by the University of
Minnesota,
The investigations and reports include:
May 26, 2004:
• J une 17, 2005:
J uly 22,2005:
The University of Minnesota Institutional Review Board
performed a routine, full-board review of the death ofDRM
The State of Minnesota's Office of the Ombudsman for Mental
Health and Mental Retardation closes its case re: allegations of
misconduct or neglect by the group home charged with
monitoring DRM
Report found no predictors of DRM's suicide and no failure by the
facility to recognize any predictors of suicide. Allegations of neglect
are found to be false.
The Food and Drug Administration concludes investigation into
complaints of misconduct related to the care ofDRM and their
clinical inspection of Dr. Stephen Olson and his role in the Cafe
Study
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Feb.11,2009:
The Minnesota Board of Medical Practice responds to complaints
against Charles Schulz, M.D., by Mary Weiss
After a review by a Board Medical Coordinator and a review by the
Board's Complaint Review Commttee, the Board found that the facts
of the case did not provide a sufficient basis for the Board to take
disciplinary or corrective action against the Respondent physician's
license.
J uly 15, 2010:
The Minnesota Board of Medical Practice responds to complaints
against Stephen Olson, M.D., by Mary Weiss
After a review by a Board Medical Coordinator and a review by the
Board's Complaint Review Commttee, the Board found that the facts
of the case did not provide a sufficient basis for the Board to take
disciplinary or corrective action against the Respondent physician's
license.
Sept. 23, 2010: The Council on Accreditation of the Association for the
Accreditation of Human Research Protection Programs, Inc.
(AAHRPP) awards the University of Minnesota full re-
accreditation for another five years
We congratulate you on this important achievement, which reflects
your organization's commitment to protecting the rights and welfare
of research participants.
Oct. 26, 2012
Board of Social Work - State of Minnesota reviews allegations
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U N I V E R S I T Y OF M I N N E S OT A
The Honorable Clyde E. A lien, J r. 600 McNamara Ahimni Center
Chair, Board of Regents 200.0ak.s',reel Ê^
M inneapolis M N 55455-2020
Office: 612-625-6300
Fax: 612-624-3318
February 7,2011
Carl Elliott, Professor
Dianne Bartels, Assistant Professor
J oan Liaschenko, Professor
Mary Faith Marshall, Professor
J ohn Song, Associate Professor
Leigh Turner, Associate Professor
Susan Craddock, Associate Professor
J oan Tronto, Professor
Center for Bioethics
N504 Boynton
410 Church S treet SE
Minneapolis, MN 55455-0346
Dear Professors Elliott, Bartels, Liaschenko, Marshall, Song, Turner, Craddock, and
Tronto:
Thank you for your correspondence of November 29,2010, in which you raise
significant questions related to the suicide of Dan Markingson, who was enrolled in
a psychiatric research study at the University of Minnesota in 2003-04. On behalf of
the entire Board, I take this opportunity to express again the University
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Page Two
February 7, 2011
I have asked our General Counsel to provide you with a more detailed response to
the allegations you raised in your letter. At this time, however, we do not believe
further University resources should be expended re-reviewing a matter such as this,
which has already received such exhaustive analysis by independent authoritative
bodies.
More generally, we note that the University maintains a human subjects protection
program that is fully accredited by the Association for the Accreditation of Human
Research Protection Programs (AAHRPP), the gold standard, to ensure the
protection of subjects participating in University research.
We do not intend to suggest that the broader concerns you raise related to
protection of subjects involved in clinical research are unimportant. To the
contrary, we encourage the University community to engage in further discussion
about these wider issues. In an era when public funding of our University and its
research is limted, we must recognize that critically important medical and health
research requires substantial private investment, both from donors and from
corporate sponsors. Those funding sources provide great opportunities - and pose
significant challenges -- for the University. We believe our faculty is ideally suited to
engage in a rigorous, open, and honest exploration of these opportunities and
challenges, and the impact they may have for the integrity of our research mssion.
We ask the administration to work with interested faculty to create an appropriate
forum where these issues can be fully examined.
Thank you again for sharing these important and serious concerns with the Board.
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University of Minnesota Mail - Possible Protests & Additional... https://mail.google.com/mail/u/0/?ui=2&ik=281fa64bb4&vievv.,
L
Brian Steeves
Possible Protests & Additional Meeting Details
BranSteeves Wed May7 2014at 857PM
To: Richard Beeson Dean J ohnson
Cc: Eric Kaler Amy Phenix
Bcc: Abdul Omari Clyde Alien David Larson
David McMillan J ohn Frobenius Laura Brod
Linda Cohen Patricia Simmons Peggy Lucas
Tom Devine J ason Langworthy Mary
Swords Pamela Hudson Sarah Dirksen
Stephanie Austin Dave McMillan (MP) Brian Steeves
T O A L L RE G E N T S
POSSIBL E PROTESTS
Whose Diversity?
We have received reports that an organization calling itself Whose Diversity? may stage protests during this
week's Board or committee meetings. You recently received an e-mail from this group outlining a series of
demands. Whose Diversity? has taken a very confrontational tone and recently organized a disruptive protest
during an event at Coffman Memorial Union (see coverage here: http://www.startribune.com/local/minneapolis
,257602471 .html). VP Katrice Albert is spearheading a response to the demands, which I will forward once it
has been finalized.
Markingson Vigil
The Board Office has also been informed that a vigil in honor of Dan Markingson is being organized for 12:00
noon on Friday, 5/9 outside McNamara Alumni Center. This is intended to place pressure on the University to
reopen investigations into the Markingson case. Additional details are available on Professor Carl Elliott's
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University of Minnesota Mail - Beeson Response to Gov. Carlso... https://mail.google.com/mail/u/0/?ui=2 ik=281fa64bb4 view...
A
Brian Steeves
Beeson Response to Gov. Carlson re: Markingson Case
BranSteeves Fri May9 2014at 439PM
To: Richard Beeson Dean J ohnson
Cc: Eric Kaler Amy Phenix William Donohue
Bcc: Abdul Oman Clyde Alien David Larson
David McMillan J ohn Frobenius Laura Brod
Linda Cohen Patricia Simmons Peggy Lucas
Tom Devine J ason Langworthy Mary
Swords Pamela Hudson Sarah Dirksen
Stephanie Austin smith, tracy Keith Dunder
T O : A L L R E G E N T S
Attached is Chair Beeson's response to a recent letter from former Gov. Arne Carlson regarding the
Markingson case (Gov. Carlson's letter is also attached).
Please let me know if you have any questions.
Brian R. Steeves
Executive Director & Corporate Secretary
Board of Regents
University of Minnesota
612-625-6300
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U N I V E R S I T Y OF M I N N E SO T A
The Honorable Richard B. Seeson 600 McNamara Alumni Center
Chair. Board of Regents 200 Oak Street S.E.
M inneapolis AM 55455
651-523-7830
Fax: 612-624-331S
fTebsile: www.regenls.fimn.edu
May 9,2014
The Honorable Arne H. Carlson
145 H olly L ane N orth
Plymouth MN 55447
Dear Mr. Carlson:
I write in response to your April 29, 2014, letter regarding the suicide death of Dan
Markingson. As this month marks ten years since his death, the University continues to express
its heartfelt sympathy to Mr. Markingson's famly and friends.
I understand you have declined our offer to meet with President Eric Kaler and me.
Again, we are happy to meet with you. At this point, however, we are responding to you in
writing.
Your letter makes assertions based on the writings of Professor Carl Elliott that have
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Hon. Ame Carlson
May 9,2014
P age 2
and practices to ensure best practices in all of our research involving human subjects. All of us
at the University are commtted to maintaining the highest integrity in our research mssion.
Sincerely,
^
Richard B. Beeson, Chair
Board of Regents
c; Members of the Board of Regents
Eric W. Kaler, President
William P. Donohue, General Counsel
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University of Minnesota Mail - Markingson Case Statement & ... https://mail.google.com/mail/u/0/?ui=2&ik=281fa64bb4&vie\ v..
A
Brian Steeves
Markingson Case Statement & Supporting Materials
BranSteeves Fr, May16 2014at 1049PM
To: Richard Beeson Dean J ohnson
Cc: Eric Kaler Amy Phenix
Bcc: Abdul Omari Clyde Alien David Larson
David McMillan J ohn Frobenius Laura Brod
Linda Cohen Patricia Simmons Peggy Lucas
Tom Devine J ason Langworthy Mary
Swords Pamela Hudson Sarah Dirksen
Stephanie Austin
T O : A L L R E G E N T S
The attached statement and supporting materials regarding the Markingson case have been assembled in
response to the recent uptick in letters, phone calls, and in-person questions being posed to the University.
I am sharing this information with anyone who contacts the Board on this matter. It concisely states the
University's position, provides a chronology of events, and includes a number of supporting documents.
The document is also available in the Resource Library >Key Messages & Background >Markingson Case
folder, linked here:
Statement & Supporting Materials re Markingson case May 2014
Please let me know if you have any questions.
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M ay 16, 2014
Academic Health Center Communications
University of Minnesota
Statement in response to calls for further inQuiry into the Dan Markineson case
The suicide death of Dan Markingson in 2004 was a tragic reminder of the devastation of mental
illness. It was not, and is not, a scandal.
Calls on the University of Minnesota to further investigate this case through public hearings or
by conducting an "independent investigation" fail to recognize some of the basic facts of the
case. Those who continue to raise the issue assert:
1. The University has refused to allow an independent professional inquiry on the matter
2. The University did not review or inform itself about the matter
In fact, this tragic event and the research study in which Mr. Markingson was a participant were
extensively reviewed by external independent agencies and the courts, as well as by the
University. As explained below, the University is also currently engaging an outside
professional to review all of its policies and procedures governing human subjects research.
Background
Dan Markingson was transferred from Regions Hospital to the Fairview University Medical
Center in November 2003 as a result of an acute episode of mental illness and was hospitalized.
Mr. Markingson was evaluated for possible commitment by the Dakota County District Court.
He was evaluated by a neuropsychologist and a psychologist prior to the hearing on his stay of
commitment on November 20, 2003, in the Dakota County District Court. Those examiners
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drugs for schizophrenia. Mr. Markingson committed suicide at Theodore House on May 8,
2004. None of his many trained caregivers observed indicators of suicide risk in the months or
weeks prior to his death.
External and Internal Reviews
This matter has been thoroughly reviewed, both internally and externally. Of particular note are
investigations by the Food and Drug Administration, the independent federal agency with
oversight for research in drug trials, and also by the state Board of Medical Practice and the
district court. There has never been any finding that Mr. Markingson's death was as a
result of his participation in the research study.
Investigation by the FDA. Upon Mr. Markingson's death, the University's Institutional Review
Board ("1KB") promptly notified the federal Food and Drug Administration ("PDA"), the
independent government agency with jurisdiction over deaths in drug trials in the United States.
The PDA conducted a full audit of the research study, interviewing witnesses and gathering and
reviewing related documents.
On J uly 22, 2005, the PDA issued its 21-page Inspection Report concluding, "No evidence of
misconduct or significant violation of protocol or regulations was found in this inspection." The
report specifically investigated, and made findings rejecting, claims of research misconduct and
lack of competent informed consent. The FDA's report is public and is included in this packet of
information. The FDA did not find wrongdoing by the University of Minnesota or the
Department of Psychiatry, or any causal connection between Mr. Markingson's death and his
participation in the study.
Assertions that the University did not notify public officials with oversight responsibility about
Mr. Markingson's death are incorrect. The principal public body responsible for oversight of
research and adverse events in research is the FDA. The FDA, both in Minnesota and in their
national office, was notified of Mr. Markingson's death by letter dated May 13, 2004, just a few
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Hennepin County District Court. In 2006, a lawsuit was commenced against the University,
the principal investigators on the study, and AstraZeneca, the sponsor of the study. After a
thorough litigation process, production and review of all records, and the depositions of dozens
of witnesses, the Hennepin County District Court dismissed the case against the University,
AstraZeneca, and one of the principal investigators, while the other principal investigator entered
into a nominal settlement to dismiss the few remaining claims.
Importantly, while the court dismissed the case against the University on the basis of
governmental immunity, the court specifically found that Mr. Markingson appropriately
consented to enter the study and dismssed all claims against all parties that Mr. Markingson did
not, or could not, validly consent to participate in the study. Thus, the Minnesota district court
reviewed the issue of Mr. Markingson's consent, which has been a central allegation of
wrongdoing by those who are calling for additional investigations, and the court supported his
ability and right to exercise his consent. In Minnesota, and elsewhere, questions of consent are
ultimately decided by the courts, and a fully informed court decided the issue.
University Review. In addition to the independent external investigations and reviews described
above, and as observed by the FDA in its report, the University's Institutional Review Board
performed a routine, full-board review following the adverse event report of Mr. Markingson's
death and found no irregularities. The FDA also found, in its independent investigation, that the
death was appropriately reported to the IRB, the internal University body with oversight over
human subjects research. The University also reviewed and responded in detail to complaints
and questions raised by Ms. Weiss, Professor Elliott, and others. The letters from the University
are included in this packet of information. You will see that, contrary to assertions by critics, the
University treated Ms. Weiss respectfully and appropriately.
Critics in this case also suggest that the Regents have not been informed of this matter. That
assertion, too, is incorrect. Included here you will find a copy of a letter from Clyde Alien,
former Chair of the Board, responding to issues asserted by Professor Elliot.
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protection of human subjects in research. AAHRPP has re-accredited the U ofMN twice since
Markingson's death, in 2007 and 2010. Another re-accreditation review is scheduled for next
year.
Both federal law and University policy require the reporting of adverse events in clinical
research. Serious adverse events sometimes do occur when people participate in clinical trials,
and they are reported to the IRB and to the study sponsor as required by PDA regulations.
The reporting of an adverse event, in and of itself, does not mean or even imply that the drug,
device, or procedure under study caused the event. It simply means that the adverse event
occurred while the person was enrolled in the study. Serious adverse event reports submitted to
the IRB are evaluated by the IRB to ensure protection of the rights and welfare of research
participants.
Recently, critics of the University's research function have asked for an accounting of how many
research subjects have died or been "seriously injured" in psychiatric research studies over the
history of the University, and to account for "the circumstances surrounding those deaths and
injuries." At any given time, the University of Minnesota is engaged in more than 2,000 active
biomedical research studies involving human subjects. The Psychiatry Department alone is
currently associated with 262 active projects. While the IRB maintains comprehensive files on
every IRB-approved research study, including adverse event reports filed in connection with the
study, the 1KB does not maintain a tabulation of adverse event reports by department, type of
research, or nature of the adverse event. Nor, in our experience, do IRBs at comparable research
institutions. Nor are such running counts required by the accrediting standards governing IRBs.
To provide an answer based on data would require gathering and reviewing literally hundreds
and hundreds ofIRB study files to determine whether a serious adverse event report was filed for
a study. Even if department leaders have no knowledge of deaths in psychiatric studies other
than Mr. Markingson's, we would not state with certainty that no death was reported in any
research study without actually reviewing 1KB files for all such studies, and such a project would
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A request for proposals has been sent, and it is our expectation that the review will be completed
in the next several months. These actions are fully responsive to the Faculty Senate resolution.
Summary
This tragic case has already been extensively reviewed in a number of forums, and in none of the
reviews was the drug study in which Mr. Markingson participated found to have caused or
contributed to his death. It cannot reasonably be argued that the University has refused to allow
an independent professional inquiry or that the agencies and courts that performed such inquiries
were not wholly independent of the University of Minnesota.
The University is committed to carrying out the Faculty Senate's request for an independent
review of our policies and practices, to ensure best practices in all of our research involving
human subjects. This review and its results will be transparent to all.
Biomedical research is a key component of the University's mission and an important
contributor to the health ofMinnesotans and the economy of Minnesota. The University will
continue to perform this important research while also maintaining a rigorous oversight system
for the protection of research participants.
Enclosures
• FDA Report (J uly 22, 2005)
• Faculty Senate Resolution (Dec. 5,2013)
• Letter from former Chair Clyde Alien (Feb. 7, 2011)
• Other letters from University Office of General Counsel
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U N I VER S I TY OF M I N N E SOTA
The Honorable Clyde E. Alien, J r. 600 McHamwa Ahimm Center
Char, Boardo Regens 2woakstne.5.Ei.
Miiwmpolis, Mff 55455-2020
Offi ce: 6L 2-625-63QO
Fax: 612-624-331S
February 7,2011
Carl Elliott, Professor
Dianne Bartels, Assistant Professor
J oan Liaschenko, Professor
Mary Faith Marshall, Professor
J ohn Song, Associate Professor
Lejgh Turner, Associate Professor
Susan Craddock, Associate Professor
J oan Tronto, Professor
Center for Bioethics
N504 Boynton
410 Chur ch Street SE
Minneapolis, MN 55455-0346
Dear Professors Elliott, Bartels, Liaschenko, Marshall, Song, Turner, Craddock, and
Tronto:
Thank you for your correspondence of November 29,2010, in which you raise
significant questions related to the suicide of Dan Markingson, who was enrolled in
a psychiatric research study at the University of Minnesota in 2003-04. On behalf of
the entire Board, I take this opportunity to express again the University
8/9/2019 Briefings to University of Minnesota Board of Regents on Markingson Case
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P age T wo
February 7,2011
I have asked our General Counsel to provide you with a more detailed response to
the allegations you raised in your letter. At this time, however, we do not believe
further University resources should be expended re-reviewing a matter such as this,
which has already received such exhaustive analysis by independent authoritative
bodies.
More generally, we note that the University maintains a human subjects protection
program that is fully accredited by the Association for the Accreditation of Human
Research Protection Programs (AAHRPP), the gold standard, to ensure the
protection of subjects participating in University research.
We do not intend to suggest that the broader concerns you raise related to
protection of subjects involved in clinical research are unimportant. To the
contrary, we encourage the University community to engage in further discussion
about these wider issues. In an era when public funding of our University and its
research is limited, we must recognize that critically important medical and health
research requires substantial private investment, both from donors and from
corporate sponsors. Those funding sources provide great opportunities -- and pose
significant challenges - for the University. We believe our faculty is ideally suited to
engage in a rigorous, open, and honest exploration of these opportunities and
challenges, and the impact they may have for the integrity of our research mission.
We ask the administration to work with interested faculty to create an appropriate
forum where these issues can be fully examined.
Thank you again for sharing these important and serious concerns with the Board.
8/9/2019 Briefings to University of Minnesota Board of Regents on Markingson Case
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v ,...:,
?, I
D E P A RT ME N T O F H E A L T H A N D H U MA N S E R V I C E S
F ood arxTD rugi Administration'
Minneapois District Office
Central Region
212 Third Avenue South
Mi nneapolis, MN S6401
Tesphone;(S12)33-(-4100
PAX: (812) 3K-41M
J uly 22, 2005
Stephen C. Olson, M.D.
Clinical Investigato.r
2450 jyverside Avenue
P282.2A'Weat-B
Minneapolis, Mtonesdta 55454
Dear Dr. Olson;
We enclose a copy of the Establishment I nspection Report (EIR) for the mspect-ion
conducted at your premises at Minneapolis,,MN, on J anuary 3-6, 1 1, 19, 21 and
26, 2005, by Investigator Sharon L, Matson of the Food and Drug Administiation
(FDA). This procedure is applicable to EI Rs for inspections completed.on or after
April 1, 1997. Per-those inspections completed prior to the above date a copy of
the BIR may still be made available through the Freedom of Information Act (FOIA),
The Agency is working to make its
transparent to regulated industry..
The copy being provided to you c<
may reflect rcdactions made by th|
CFR Part 20, This, however, does
obtammg additional information
egulatoiy process and activities more
ieleasing the EIR to you Is part of this effort,
iprises the narrative portion of the report; it
I'Agency ui accordance -with the POIA and 21
>ot preclude you from requesting and possibly
deFOA ••
I f there is any question about the released information, feel free to contact me at
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Establishment Inspection Report
Stephen Qlson, MD
Minneapolis, MN 55454
F B I ;
El Start;
El E nd:
3004927371
01/03/2005
01/26/2005
TA B L3 E O F C O N TE N TS .
SUMMARYOFF̂ oNGS............,.................;.,..........;...............,...........,...,,,..,...........,,,....,..̂
ADMNSTRATFVEDATA,............,...,,„......,........,,....,,....,..,...,,.,.,...,,.,..,,...,,,.,........,............,, 1
raSTORYOFBUSNESS........;.......,....,..,...,.,.,;.,.,.......,,,.,..,,.,...,..,,.,:.......,........,.....-..;..,...,.......2
PERSONS INTERVIEWED and rNDP/IDUALRBSPONSIBILITY..,.,....,,..,,.......,..,,........,,,..,3
DS Compan 1006,...,,,.,...,.,.....,....................;..........,,.......,.....,...,,.,......,;...,...,,......,;.,,.....,....,,5
~NSFECTON...........................,,..,.,,,,,...,,,,......,.-...,».̂ ...,....,..,.,...,,,..,..,o....,...̂
DATAAUDT.,,,.....,....,..,.,....,..,.,,,..,.......,.,..,...̂ ..,..,...,.....,..,.......,....,,.,.,...,..,.,.......,..,..,,.......,.l5
DSCUSSONWTHMANAGEMENT....................................................................................ie
ATrACĤfiNTS...........................................................u,.................,..,,;.....,....,....,.,,....,...̂
EX̂TS...........................................................................................................̂
S U M M A R Y Q T V W W N GS
I conducted this clinical investigator inspection and data audit per a For Cause assignment-from the
Center for Dmg Evaluation and Research (CDER/HPD-46), dated 12/14/04 to follow-up on Division
of Scientific Investigations Complaint #1 ̂ 06 (Attachment #1 and 2).
This is the first FDA inspection of this cjmcal uivpstigator,
•s
The study assigned for audit is titled "Efficacy and Tolerability ofOlaazapuie, Quctiapine and
Risjperidone in the Treatroent of First Episode Psychosis: A Randomzed Double Blind 52-Week
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EstabJ ishmeat Inspection Report
Stephen Olsor), MD •
MinneapoliSi M M. 55454
F B I ;
El Start:
El End:
3004927371
01/03/2005
01/26/2005
F282-2A West-B
Minneapolis, MN 55454
Phone; 612/273-9763
FAX.; 6.12/273-9779
.Maing address: (samea5 above ' ;
B-mai-1: [email protected]
Dates of inspection: 1/3/2005, 1/4/2005, 1/5/2005, 1/6/2005,1/11/2005,1/19/2005,
1/21/2005,1/26/2005
Days in the facility; 8
Participants; .SharonL, Matson, Investigator
jH ISTORYOF.BTCjlStNESS
Stephen C. Olson, MD started at the University of Minnesota (UMN) in December 2000 as an
Assoqi'afe Professor of Psychiatry. He has been involved in clinical research as a principal and co-
investigator since about 1986 and those studies are listed in his CV, attached as .Exhibit til .
Besides teacliing and research. Dr. Olson's responsibilities include; . '
• Director, Schizophrenia Program within the UMN Academc Health Center
• - Attending Psychiatrist on Station 12, FUMC'R (farthei described below)
• pacUitatwg some group therapy ses'sions at the FUMC-R. Day Treatment (")
•, arid, providing private outpatient practice services.
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Esfabishtnen InspectionReport FBI: 3004927371
Sephen0(son MDE Sart: 01032005
MnneapoJis, MN55454El End; 01/26/2005
Dr. Olson is compensated through both University of MN Physicians (UMP) as an independent
licensed physician, and through UMN research funds.
PE R SON S I N T E R V I E W E D and I N D I V T D U A I / J R .E SPO N SFB I L I T Y
This inspection was uneunnou.noed. I showed up at the referenced address, showed credentials, and
. issued a FD 482 Notice of Inspection to Stephen C. OIson, MD, Qjnical ]av
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Estabishment InspectionR.cport FEI; 3004927371
SephenOson MDE Sart: 01032005
Mnneapos, MN5545< E End; 01262005
Admnistratively, as UMN psychiatry staff Dr. Olson reports to Dr. Schulz who reports to Deborah
Poweil, MD, Dean, Medical School, UMN ->Frank Cerra, MD, Senior VP, Academc Heallh
Center, UMN ->Robert Brumnks, President, UMN, 100 Church St., Rm 202 Moml Hall,
Minneapolis, MM 55108.
J ean Kenney became the study coordinator in 6/Q2 ajfter the original coordinator - Rvtl i T liomson,
left. Ms. Kenney's responsibilities for this study include evaluating patienls ability to consent;
explaining the study to prospective subjects'and obtaining nrfohned consent; seeing subjects at eactf
visit; performing evaluation.s; receipt, dispensing, and accounting fortest articles; entering data
collected into electronic case report forms; participating in monthly study coordbator telephone
conferences; and, overseeing other staff fhat perform some of the above. Ms.Kenney is 40% paid
fhrough UMP as an independent licensed social worker at FUMC-R, outpatient. She is 60% paid
through UMN researc} funds. She reports to Dr. Olsan, Her CV is attached as Exbjbit#4,
A number of study staff besides Ms, Kenney were trained and Certified to'perform evaluation scales
such as the Structured Clinical Interview for DSM -TV Ax^s I Disorders (SCID)| Positive aod
Negative Symptom Scale (PANSS), and Clinical Global Impressions (COT) per review of records;
Elizabeth Lemke, Julie Pcarson, Tanya Adelman, Angda Guimaraes, and Christa Surerus-J ohnson,
TAcy al;o were involve.d in explaining the study to subjects and oblflim'ag and/or witnessing signed
consent. Ther CVs are attached as Bxlp'bj't #5 - 9. ' .
I spoke to several other persons by phone iri the course of this inspection and complaint follow-up;
Bill Andersen, Eagan Counseling Clinic (a memo of telecon is atteched, A_ttachn]en1 #4J
Adrienne Baranauskas, Director of Research, FUMC-R ••
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EsfaMJ shmcat Inspection Report
Stephen Olson, MD
Minneapolis, MN 55454
F E I ;
El Start:
El End;
30(M927371
01/03/2005
01/26/2005
Internal medicine consult" TSH normal, hypsrlipidema, elevated total bilirubin;
othenvise normal.
11/14/03 Psychosis NOS, DSM code: 298
Examiner's Statement in Support of Petition for Commitment by Dr. Olson states '
psychosis N03: paranoid schizophrenic vs. psychotic rnaniiivs. psychasis dw to
meidica.1 conciir ioa per examination 11/13/03.
11/15/03 Psychosis NOS
ll'/n/03 Attending Note stales MRJ and -thyroid studies normal, Diagnosis: Psychosis N03
Pre-Petition Screening Program Report recommends Qommitaient due to "mentally
ill", diagnosed Psydiosis NOS, Mood Disorder'N03; R/0 Bipolar, R/0
Schizophrehia '•:
11/18/03 . Psychosls NOS - schizophrenia vs. mania •
Neuropsychologfcal evaluation - normal fimctioni'ng
111903PsychossNOS. ••
112003PsychossNOS• • . .
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Est'itblJ shjnfindnspectioT) Report
Stephen Olson, M E )
Minneapolis, MN 55454
F B I :
El Start;
El E nd:
3004927371
01/03/2005
01/26/2005
11/25/03 PsychosisNOS
11/28/03 Psyohosis N.OS
11/29/03 PsychosisNOS
12/1/04 Psychosis NOS, probable paraaoid schizoplirenla
12/2/04 Psychbsis NOS-
12/3/04 PsychosisNOS
12/4/04 Psychosis N03
12/5/(M Psychoss's'N~OS,..probable paranoid schizophninio ••--
Baseline visit with Ms, Kenney, DRM to begin test articls that evening
12/8/04 • Discharge Diagnoses, Axis I;
PsychosisNOS
Probable schizophrenia '•
.Questionable history of alcohol abuse versus dependence
As noted, DRM met criteria for schi'zophrenia on 11 ,24/03 per Struclured Clinical Interview for
• DSM-IV Axis I Disorders (SCID) -Exhibit #16. He r&tams the diagnosis ofschizophrenJ a
throughout outpatient study visits - records attached as Exhibit #17.
In evaluating a new, psychotic patient Dr. Olson described the first things they lo'ok at to rule out are
a medicai condition, drugs, and then mood disorder, When asked how bipolar psychosis was ruled
out Dr. Olson described thsri they took a detailed history fsom tbe mother; Neillier mom nor DRM
could identify anyone that could provide, first hand accounts of his behavior while living iu
Califoraia [for about 3 years] other tlian brief visits by the molher on 2 occasions, DRM.did not
report any manic episodes - question A16, SCID (Exhibit #16). Dr. OIson described that ultimately
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Esfabb'shment I nspection Report
Stephen 0]son, MD
M'iimeapolis, MN 55454
FB I ;
El Start;
EJ End;
.3004927371
01/03/2005
01/26/2005
2) DRM was court ordered to get medical treatment and instead was put in a study,
Court and coiirt-related documents are attached as Exhibit 1̂9, A petition for commitment was filed
forDRM 11/17/03, A stay oF coTnroitment was court ordered 11/20/03 for 6 months under agreed
upon terms and conditions tha.t included (Exhibit tfl 9 paw 13);
•• remain hospitalized and cooperate with trea.toient until medically discharged;. ,
» enter, participate, and complete an inpatienVoutpatient treatment program and aftercare
rs'comm&ndations as determined by social worker;
« cooperate and follow rules at n̂y living-facility arranged by social worker;
" take dmgs or medica-tions only as prescribed; and, •
o • cooperate with social v/orker'as determined,
The terms of the stay of commitment and conditions ofdisch'arge are rorived at by a patient's
treatment team that includes a- psychiatrist and county Case Manager, in this cnse David Pettit. I was
not able to meel/talk/review records with Mr, Petti't as noted above but a 12/11/03 progress note
stales that he was supportive ofDRM being in fte CAPS Study . ExhLbJ t #17 pagelZ..
Before discharge from Station 12, arrangements for after care are discussed and made. The choices
'for DRM included participating in a study or receiving standard luedical care. Wjhen asked what
"stendard care" is Dr. OIson described that most patients would tie prescribed medication and asked
to return within a couple weeks of discharge and on some regular basis after tbal. He said the wait
for & new patient to gel in with a psychiatrist -is about 4-6 weeks. Standard care was described
simlarly by several others (telecons noted above)" patients see a psycliiatrist for medication
tolersLnce checks atiout each 3 nionths for 5-10 minutes. Dr. Olson and Ms. Kemiey described that
at least one significant advantage of a clinical study is tliat a patient is seen more -frequently, for
longer visits, and can therefore be more closely monitored. They des&ribed Vast medication
compliance is very important and with'more frequent monitQring, compliance is better, He said
there is a 5x greater rate ofre-bospitalization for patients who do not take tlieir Btiti-psycliotics,
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Establishment Inspection Report
Stephen 01 son, MD
MiruaeapoHs, MN 55454
F B I ;
El Start:
El E nd;
3004927371
01/03/2005
01/26/2005
3} DRM was no( in a state to have been able to give voluntary, iuformed conssnt.
As noted, DRM was admitted to FUMC-R on. 11/12/03 upon transfer j&ocri Regions Hospital where
he had been brought in by police in handcuffs and placed on a 72-howhold, By 11/13/03 he started
• taking Risperdal voluntarily while i.npatieirt on Station 12. A pelition for commitment was prepared
and filed in. court 1 1/17/03. On. 11/20/03 the court issued a stay of commtment. The terms ofths
stay and conditions of discharge were arrived at by DRMs treatment team. At no time was DRM
under aJam Oder, .' •
On 11/21/03 DKM was evaluated as able to give consent by Ms. Keoney and witnessed by Ms. •
Lemke. He subsequently signed tho study consent fonn with Ms, Kenncy and Dr, Olsoii, Both the
evaluation and consent documents are attached as E5{bibit_#14andl5, Note that the evaluation of
sulj ects abili ty to consent is an addi-ti onal step perfbnned at tliis study site - it Is neither Teqwr ed
nor mentioned in the study protocol.
By the time DRM consented on 11/21/03 he had undergone an internal medicine'evaluation
(11/13/03), had an MRI and thyroid studies (11/17/03), a neuropsychological ev&l wtiou (11/18/03),
a chemical dependency evaluation (1 1/21/03), and had been observed on a daily basis by n'u.merous
medical and'mental health care staff oa S-tation ,12. There was nothing different about this subject
than. others enrolled to indicate he couldn't provide voluntary, informed consent per review of his
medical records or the approved study pyotocol which allows foreiu'ollineot ofinpatient subjects,
4) DRM was kept on s.tudy despite deterioration.
DRM consented to Un's study 11/21/03 and began taking study medication 12/5/03, The symptom he
• consistently scored on the PANSS a.s mild to moderately severe is'G12, "Lack ofiudsroent.gnd
jnsight; Impaired a-wareness or understanding of one's own psychiatric oondition and life
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Est.abh'shmendjispecdoti Report
Stephen OI son, MD .
J vlinneapoli 's, NW 55454
F E I ;
El Start:
El E nd:
3004927371
01/03/2005
01/26/2005
""'Abbreviated PAWS at screening
*rater up to Visit S9 was J ean Kenney, V10 and VI 1 ralerwas J ulie Psarson
The SAE report for DRMs death CExhibit#12) states in pan "Over the last few months, DRMs
ADLs have detwiorafcd, often with a dish'eveled appearance and wearing the same dothes &s
previous visits." I asked Ms. Kenney about "ADLs" and she described that it is terminology, not an
actual list or scale that is do.cumentsd and tracked. There is also a reference to dwli'ning ADLs in a
pTOgress note (Exhibit #] 7.page 18). Otbeiwise, leview ofDRMs records - attached and described
further b
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n
Establi'sbmeu.t Inspection Report
Stephen Olsbn. MD
Minneapolis, MN 55454
F E I ;
El Start;
El E nd;
300'19Z7371
01/03/2005
01/26/2005
4/28/04 Visit #) ], Calgary Depression Rating Scale is performed looking at 9 items and DRM
is raled 1 - Absent for each indicator of depression,
-PANSS comments; "DRM presents disheveled today, .hair vnkempl, wearingj&cket
onho day •
Besides tlus study, DRM was participating and being obsen'ed in'hls group bome - Theodore I; the
Day Treatment program at FUMC-R three llnies per week; mdividuaJ therapy at Ihe Eagau .
Counseling Clinic; and regularly meeting with his Dakota County Case Manager who is (he
responsible liaison between the court and physician for a committed person. No deterioTa.tion
' appears to havebeennotedinthesearenas. . ' ' . •
When DRM was discharged Irom tlw FUMC-R on 12/8/03 he went directly to TJ ieodore I, a "Rule
36" residential facility for adults with mental illness. Dr. Olson described that DRM would have
been discharged sooner but they were waiting far bed to become available at Theodore I,
"Medication exchange records" were earned by DRM between Theodore I with steff notes on one
side and MD/Dr. CUson notes 'on the other. No problsms were noted in exchange records except on
3/30/04. That note states home staff began more rigorous medication check with DRM - liaving him
observed during and after dosing>to assure, he was swallowing meds- [It was suspected that he
mght be palmng medication because of one occasion when it was thought he brought his hand
down from his mouth too quickly - see Memo of Tekcon with Eric Anderson, Attachment #8] . No
other concerns were suggested 'by the notes which are attached asExhjbiL ffl 7 page 20 - 27,
DRM was admtted to the FUMC-R outpatient Day Treatment Program on 1/14/04. In this
program he received 2 boui-s of group therapy and 1 hour of occupational therapy 3 times per-.week,
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Estabishment rnspectionReport FE[: 3004927371
SephenOson MDE Sart; 01032005
Mniwpois, MN55154• . El End; 01/26/2005
person interviewed as a very good, involved, experienced case manager. There was no indication in
records, discussion, or interviews during this inspection of disagreement with DRMs enrolling or
con-tiniting in this study.
' Overdll, there is no evidence of suggestion or request lo clmge DRMs treauxisnt plan, change
medications, or re-bospitaUze him from.any of the 4 non-study arenas noted.
At the same time. Dr. Olson described that no one was in favor of dropping DRMs commitment.
when his 6-monfh slay was neanng expiralion. He said DRM cii'd not object tQ tbis. He said their-.
inlention was to keep. him in the area, to stabilize and continue treatment whether on or off study .
instea'd of rushing on his ultimate goal which was to return to California, Dr. Olson's :
recommendation to extend his stay of commtment is attached as Exhibit #]g pâ e ,1̂ .
. Both Dr. Olson and Ms. Kermay said DRMs main presentali'ori was not fully graRplng, having insight
into the severity ofhi's disease. He did not present any depression, syicidal thoughts, satanic or •
religious thoughts [as had been present at admt]. He appeared to be compliant with medications.
He was thought to have improved somewhat in. the Day Treatment program such that close to
discharge from that program he was looking for an apartment with his case manager, and bad started
at a drop mcenler/coromuiuty program. They were aware that DRMs mother did no
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Establishment Inspection Report
Stephen Olson, MD
MinncapoHs>MN 55454 •
F B I ;
El S tart:
m End:
3004927371
01/03/2005
01/26/2005
5) The Cis are guilty of miscouduct and the University ofMN is possibly shieldiug tb.eir
staff,
I did not find any evidence of msconduct, significant violation of the protocol or regulations
go-verrung clinical investigators or LRJ 3s in tTiis inspection, data audit, or interviews.
Other J nvestis;atlons of DJ RjMsJ cathj. (1) The UMN ?.8 perfonned a routine, full-board review of
• DRMs dwtb/SAE. No in-egularities were noted or further follow-up performed per recoTds (EsMbit
#12̂ &ge-3s) and per contact with the LRB (memo oftelecotr'withMoiraKeane, Attsclimeni #7),
(2) A post-mortem/morbidity and mortality conference on the DRM case was conductsd'on 1/5/05.
No reports, sununaries, notes, pr formal recommeDdations were or are roads reportedly. I t is a
' hospital-driven internal peer-review used for improvement and teacliing per Keith Dunder, XJ MN
artomey (reference memo oftelecom, ̂ ttacfcment#5),
(3) The MN Department of Human Services perfonned an investigation in response to a Complaint
' that staff at the Theodore I group home neglected DRM, a "vulnerable adult" prior to his death at .
that facility. No indication of maltreatmeiri/neglectof supervision was found and no further follow-
up recommended. The report was provided througli MN DH3 and is attached to a memo oftelecom
with Investigator Norm Isaacson - Attachment #6, . . -
(4) DRJ Mts death is also being investigated by the MN Office of the Ombudsman for Mental Health
8t Mental Retardation. That investigation is still in-process. Results will be available publicly.' See
memo oftelecom with J o Zillhardt of that ofiioe.- AttechmontfflO,
Dr. Olson said [and records show] that in addition to the above he and Ms. Keimey have been
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Establishment Inspection Report
Stephen Olson, MD
Minneapolis, MN 55454
F B I ;
El S (art;
El E nd:
3004927371
01/03/2005
01/26/2005
INSPECTION • •
Pro(ocol: The protocol sent with this assignment - ASfifI lElSUt ̂]s the saiae as that on she and so
no additional copy was collected, Deviations from the protocol were documented and a log is
attached for reference as Exhibit #22, No un-reported deviations wore founci In tliis inspection.
Sub fee ts ̂ r ec o rd s; Subject records consist of a din ical cbarf/binder containing signed conssnt
forms, lab reports, shidy visit note's, etc,; and, a binder of source data forms for mainly the various
evalualion scales, e.g, SCID, PANS S, CGL These are maintained in a locked room in the ARC,
Subjects additionally have an inpatieut medical chart if hospitalized and ovtpatleaf medical chart
ifs/he participated in for example the Day Treatment program, which are maintained ui themedical
records department at FUMC-R, Subject records are adequate to account for all subj'Bcts through
their stated participation in.lhis study. There are examples of subject records for DRM attadied as
Exhibit #17, 2L13, and ,20, respectively.
.GoxiscnJ ' of human ŝubi'ects:, A consent form is on file for each subject, signed prior to screening,
per review of subject Source records. Additionally, an Evaluation to Sign Consent Fonn was
performed, witnessed, and documented for subjects prior to obtaining informsd consent. This •
CivaJuation to sign consent form was initiated liy this site, i.e, it was.ncrt required or suggested by the-
protocol or sponsor. Ah example signed consent fomi and evaluation are attached for reference as
Exhibit #14 and 15. The consent form vras revjsed on 5/2/02,7/1/02» 10/23/02, 3/25/03, and 3/24/04
• and approved by the IRB.
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Establishment Inspection Report
Stephen Olson, MD
Mimeapoli's, MN 55454
F B I :
El Slart;
El End; .
3.004927371
01/03/2005
01/26/2005
To date, reports and change requests appear to have been appropriate and submitted timely with one
exception- see verbal observation #2 under Discussion with M'anagemenf regarding a consent
form update on risks ofdiabeies and hyperglycema. Also, the original application to the IRB stated
this study wasn't associated with an I ND- verbal observation # 1. .
Adverse even (s:. Adverse events to date appear to have been appropriately captured and. reported per
review of subject records. Two serious AEs occurred and were reported'to Ihe sponsor and IRB;
» Subject ifl3/DRMdeath73uic)de on 5/8/04-ExhibiV ,̂ •
« Subject #20/CLW pregnancy/fetal raisearriage on 5/6/04 - exhibit #24.
Sponsor/moBi'tor:. Quintiles is the contract monitor on this study. A Senior Clinical Research •
•Associate from CJ ncuatti; OH was assigned to this site first fQllowed by another senior CRA. located
in Waulcosha, WT. The first monitor visit-was on 1/7/0.3 and additicmal visits liave lieen made about
quarterly including during this inspection, the week of 1/10/05. A copy of the Site Visit Log and
post-visit letters/r.eports are attached for reference as Exhibit K25, . •
Test article accountability: Test articles were ordered for mdividuid subjects via an Interactive
Voice Response System (IVRS) phone system operated by QuintiJ es CTriangle Park, NC). Test
articles were delivered to the attention. of-Ms, Kenney at the ARC, Subject compliance was checked
at each visit. No deficiencies were noted in accounting for test articles received, dispensed, .or
returned. Records appear adequate to track all TAs received and dispensed.
iilectfoni'c records and signatures: Data was eriteTed into an e]ectronic,system from source
documents such as data forms provided by the sponsor/monitor, lab reports, etc. versus direct entry.
None of the electronic case report forms are copied or kept here and I did not request any for review,
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EstabIisbmentTnspectioaReport FEf; 3004927371
SephenOson MDE Sart; 01032005•
Mnneapos, MN55454 B End: 01362005
Record ŝ -evjewed in this inspection and data audit that gre not elsewhere noted include;
» ail correspondence with the sponsor, monitor, and JRB
» 1572's" copies are aUached as Exliibit #26
i- ]2 sets of subject records in depth, mcIu(iingsubject#3/DRM . .
» , all subject records regarding consent, eligibility, adverse events, concomitant medica.tions,
current status, etc.
e financial disclosure information .
h)bitf23̂ ESge-5J . Eventuiilly thj's-was resolved, Dr. Olson said he didn't know an IND
. was involved initially. I stated this is important information to provide to an IRB, why, and that any
•trale he signs a 1 572 that's an indicator that he's working on an &QD study. He said he is more
aware of this now and will be attentive to it.
2. Study site's wê apprised of new risks of diabetes aud hyperglycema by the sponsor on S/15/0'1.
This site added new risk language to the consent forms on 3/24/04 bnt did not submt these changes
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Estflbtishroent Inspection Report
Stephen Olson, MD
Minneapolis, MN 5S454
F E I :
E l Start;
pl End;
3004927371
01/03/2005
01/26/2005
ATTACHMENTS
1. Assignment from CDER/HFD-46, dated 12/14/04
2. Complaint, and log of communications since the complaint
3. Protowl, dated 3/1/03
Memos ofTeecons:
4, Bill Andersen, PhD, LP, Eagan Counseling Clinic, Eagan, MN
5. Keith Dundcr, Attorney, Office of the G ênera.1 Counsel, AHC, UMN mcluding-copies of
ie.tters he's sent to DRMs mother and requested to'fo'i-ward bare
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EstaMishmeatIuspection Report
j , - StephenOson MD
Minneapolis, MN 55454
FB I ;
El Start:
El End;
3004927371
01/03/2005
01/26/2005
13. DKM inpatient medical records;
•AdmssonNoe 111203
»Interna mdcneconsut, 111303(pg3) ::
• Discharge Summary, 12/8/03 Cpg 4)
» Regions Hospital Emergency Center records (admit prior to transfer here) j
o72HouHod 111203 (pg7 ••' ̂
o Crisis Program Psychiatric Assessment, 11 /12/03
o Emergency Physician's Record
oEmrgencyNursngRecod —
Progress notes,1112-] 2803(pg] 2 incudng Atendng Notes on • • ;
o111303pg15 • . . ^̂
o111703pg25•
o111903pg29 •
o 11/21/03 (pg 35)
o112503pg40
o12103pg46•
o 12203pg48•
o12303pg51•
o12503(p36• . . . .
o12803pg58 . •
Odeso treaenen pg60}. . . .
MedcaonAAanstratoi Recods (pg71 ' • ' • :
Neuropsychological Evaluation, 11/18/03 (pg 78)
Chemcal Dependency .Evaluation, 11/21/03 (pg 82)
Adut CDAssessmn, 112803(pg83) • '
Treatment Plan Review on 11/21/03, 12/1/03, mid 12/8/03 (pg 84) ' .
Adut Sr Assessment ofSucdeRiskforDsoharge 12803(pg 87 i
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'•a. -.,
EstabJ ishme.n ̂Inspection Report
Stephen Olson, MD
Minneapolis, MN 55454
FB I :
El Start:
El E nd;
3004927371
01/03/2005
01/26/2005
19, DRM court and court related records:
» Petition for J udicial Commtment, I V] 4/03 filed. 1 1/17/03
• Examner's Statement in Support of Petition for Commtment, 1 1/14/03 (pg 3)
» Pre-Petition Screening Program Report, 11/17/03 (pg 5)
» Order to Confine, to Transport for Examination, Hearing; Appointment qf Attorney,
Examner and Noce 111703(pg9) ' . . • •.
o Order to Release Medical Records, ] I/] 7/03 (pg '11)
• ' Court Medication S.ummary, 11/20/03 (pg 12) .
*. Findings of Fact, Condusions ofLawand Order for Stayed Commtment, 11/20/03 (pg 13)
» Court Medication Summary, 1 1/26/03 (pg 17) •
• Letter la Dakota County Social Services from Dr. Olson, 4/27/04 re; recommendation to
extend stay of commitment to disallow leaving the state, (pg ] 8)
• Addendum to 4/27/04 letter from J ean Kenney, 5/3/04 re; diagnosis info. - 295.30
Schizophrenia, paranoid type,(pg 20)
20. DRM outpatient chart records:
» Discharge Summary, 5/5/04,
• • Adult Day Treatment Progress Notes, 1/14 - 5/5/04 (pg.4)
* Intake assessment, 1/J 4/04 (pg 39)
• PhoneContacts log(pg45 . . • .
• Miscellaneous correspondence
21. Source Document data forms, portions ofFANSS aiid CGI with any score of 3 or higher,
sereenng to Vst #11• •
22 Prooco DevaonLog•. •
23. BR.B records;
• Portionof appicationfor IRB revew, 21102. • •
* Response to IRB from Dr. Otson, 4/3/02, including re; ,'itatus of test articles (pg 5)
. • Progress report to IRB, 12/24/03 (pg 7) ' •
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•• >' •«
Establishment Inspection Report
Stephen OIson, MD
Minneapolis, MN 55454
F B I :
El Start;
El E nd:
3004927371
01/03/2005
01/26/2005
26. -1572s, dated:
4/2/02
6/13/02
11/25/02
10/21/03
12/22/03
1/7/04
7/9/04
--.»• 12/17/04
ĈVA ,̂ ( , /̂ .
Sharon L, Matson, Investigator
Issues Arising from the CAFE Study and the Suicide of Dan Markingson hllp://wwwl.umn.edu/usenate/resolutions/131205panelres.html
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Approved Faculty Senate - December 5,2013
by the: Administration - Faculty 2014*
Board of Regents - no action required
*The Admnistration recognizes the Faculty Senate resolution requesting an external
review of clinical research on human subjects at the University of Minnesota and is
moving forward with this review. The review will be managed by an independent,
external firm who is expected to call upon national experts in the field of clinical research
on human subjects research and who are widely recognized for their expertise, knowledge
and achievement in this field. This review will include a review of relevant standard
operating procedures and an assessment of University compliance with regulations and
applicable law. It will result in a detailed report outlining strengths and weaknesses of
current policies, practices, and oversight and any recommendations for any deficiencies
identified. This process will include consultation with faculty and the final report will be
public.
Issues Arising from the CAFE Study and the Suicide of Dan Markingson
PREAMBLE:
In May 2004, Dan Markingson, while enrolled in a clinical trial of an antipsychotic drug (the CAFE
study) at the University of Minnesota, committed suicide. Since then individuals and groups within
and outside the University have raised questions about the study, how Markingson was recruited into
it, his treatment during the study, and the circumstances of his suicide.
On October 21, 2013, a letter co-authored by six bioethicists from outside the University, with 175
co-signatories, was addressed to President Eric Kaler and Professor Eva van Dassow, as chair and
vice-chair (respectively) of the Faculty Senate, and to members of the University of Minnesota Senate.
The letter asked the Senate to endorse and request an independent investigation of the issues arising
from the Markingson case and the CAFE study. That letter is available at: http://wwwl .umn.edu
Issues Arising from the CAFE Study and the Suicide of Dan Markingson http://wwwl.umn.edu/usenate/resolutions/131205panelres.html
8/9/2019 Briefings to University of Minnesota Board of Regents on Markingson Case
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specifically had been investigated several times from different perspectives, and that those
investigations did not address the broader question of whether the University's current policies,
procedures and practices, some of them changed since the Markingson case, reflect both best practices
in clinical research on human subjects and the faculty's high ambitions for ethical behavior. Members
of the FCC also recognize that external evaluations can have the advantage of fresh perspectives not
biased by familiarity with current practice, and are a way for the public to have the utmost confidence
in the integrity of the research conducted at the University of Minnesota.
For this reason, the FCC feels that the way forward is to recommend that an independent and
transparent examination be undertaken to evaluate the University's procedures, practices, and policies
governing clinical research on human subjects, and in particular clinical research involving adult
participants with diminished functional abilities. While the specific charge for such an examination
requires further work, FCC believes issues to address may Include investigator conflict of interest,
institutional conflict of interest, consent policies and procedures, case management of enrolled
participants, mechanisms for overseeing such research and mechanisms for addressing adverse events.
Therefore, the FCC suggests to the Faculty Senate the following resolution:
Resolution on the matter of the Markingson case
WHEREAS the faculty of the University of Minnesota are committed to upholding high ethical
standards in the conduct of research;
WHEREAS questions continue to be raised about the policies and procedures followed in the case of
Dan Markingson, a 26-year-old participant in a clinical trial who committed suicide in 2004;
WHEREAS the University has suffered reputational harm in consequence of this tragic case and its
aftermath;
WHEREAS the faculty seek to ensure through independent evaluation that the University's ethical
standards for clinical research on human subjects meet or surpass the norm,
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U N I V E R SI T Y O F M I N N E SO TA
Office nfllie Gcnerul Counse 360 McNwncnv Alumni Center
200 Oak Slreel S.E.
M inneapolis. M N 5545 S
Office: 612-624-4100
/YU-; 612-626-9624
J une 7, 2011
V I A E - M A I L
Professor Carl Elliott
Bioethics
N-302 BoynHS
1171
410 Church Street SE
Minneapolis, Minnesota 55455
Dear Professor Elliott:
This responds to your request for background information related to the
letters you received from the Board of Regents' Chair Clyde Alien and myself
dated February?, 2011 regarding the Markingson matter.
You indicated that you have reviewed "the litigation." If so, you have long
had available to you the reviews by external psychiatrists and other experts
contained in the court files, as well as the decision of the Hennepin County
District Court. Nevertheless, for your convenience I have attached electronic
copies of the decision of the court dated February 11, 2008, and summaries of
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Professor Carl Elliott
J une 7,2011
Page 2
University is unable to provide documents to you detailing the conclusions
reached by these governmental units m this matter. However, as you have
indicated publicly that you are in communication with Mary Weiss, who made the
complaints to the Board of Medical Practice, you may ask her for copies of her
complaints and also obtain from her, as the compiainant, the Board's conclusions
regarding her complaints.
Sirycerey, /\
/
l
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U N I V E R S I T Y O F M I N N E SO TA
Office of the Generuf Counsel 360 McNmnara Alumni Center
200 Oak Str eet S.E .
M inneapolis, MN 55455
Office: 612-624-4100
Fax: 612-626-9624
April 22,2011
M ike H oward
9876 H amlet L ane South
Cottage Grove, M N 55016
Dear Mr. Howard:
I am writing in response to your letter of April 6,2011, in regard to the "signed Caf6-HIPAA"
release. You inquire as to where that document was found.
I am advised that the document was located among the voluminous records in the lawsuit
relating to Dan Markinson's death.
Sincerely,
^̂ U4̂ h ^
J
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U N I V E R S I T Y O F M I N N E SO TA
Office ofllie General Counsel 360 McNamara Aiumni Center
200 Oak Street S.E.
M iimeapotls, AW 55455
Office: 612-624-4100
Fax.- 612-626-9624
March 16,2011
Mr. Mike Howard
9876 H amlet Lane South
Cottage Grove, MN 55016
Re: Complaint of Misconduct against Stephen C. Olson, M.D.
Dear Mr. Howard:
The Board of Regents has asked me to respond to various allegations you raised in a complaint
submitted to the Board in April 2010 against Dr. Stephen OIson, Associate Professor in the
Department ofPsychiaby in our Medical School.
The University identified seven allegations in your lengthy complaint materials. After careful
examination of each allegation, we have found no University policy violations or other improper
conduct by Dr. Olson warranting University action against him. Each allegation is outlined
below, followed by a summary of the University's findings.
Allegation 1. Dr. Olson shared protected health mfonnation in regard to Dan Markingson with
members of his research team without obtaining a HIPAA release from Mr. M'arkingson.
University Finding. Attached is a copy of the HIPAA authorization executed by Dan
Markingson on November 24, 2003.
Allegation 2. Dr. Olson did not understand how or when HIPAA regulations applied to
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Mr. Mike Howard
March 16,2011
P age 2
Markmgson could participate in the study. The interval behveen the date the consent was signed
and the randomization date is th:e "screening period" during which there were no changes in his
treatment. I f the case manager had determined that the study was not an appropriate form of
ti-eafmeht, he would, have been dropped before giving him study medication. Mr. Markingson
began receiving study medication on December 5,2003.
Allegation 4. Dr. OISon testified in a deposition that he had no knowledge of certain regulatory
Statutes requil-ed for conducting clinical trials and the protection ofhdman subjects.
- University li'iiidiug; A GOm'plete reVi'e'w of Di-. Olson's depogition transcript, consisting of
hmdreds of pagieis,, Simply does Hot $uppoft this allegation.
AU'egafion 5. Dr. Olsort allegedly delegated the dispensing of very powerful aflti-psychotic
drags to a study cooi-diriator not licensed to dispense drugs, who had received no prior training
flof education regarding how these drugs are taken.
UAiversity Finding. Dr. Olson was assisted in the CAFE Sfudy by a research coordinator who
had a bachelor's degree in psychology and a master's degree in social work. As the study
coordmator, ftds person worked under the close supervision of Dr. Olson as the principal
investigator.
Throughout the study, Dr. OlSon was responsible for "dispensing" the medication in his capacity
as principal investigator. .Under Dr. Olson's supervision, the study coordinatbr merely gave the
pre-packaged and marked bottles of pills to Mr. Markingson. Mr. Markingson, upcinretummg to
Theo House, the half-way house where he resided, would then give the bottle of medication to
the Theo House staff Wlio oversaw the delivery of the medication to him on a daily basis, and
helped assure that he wa's taking the right doses at the right time.
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Mr. Mike Howard
M arch 16, 2011
Page3
interest, and must conduct themselves accordingly. Dr. Olson did not violate any University
policy.
Allegation 7. Dr. Olson acknowledged having received numerous mentally ill patients in the
psychiatric unit at the University into his own study.
University Finding. I t is true that Dr. Olson, and many other researchers, have enrolled
mentally ill patients into studies. Academic clinical research into mental illness, and the
potential to cure mental ilbiess, requires research involving those who suffer from mental ilkiess.
The issue is not whether such mdividuals may participate in such research, but whether
appropriate protections are in place to protect those research subjects, All clinical research at the
University involving a mentally ill patient is reviewed by the RB to assure that the study
protocol is appropriately constructed, and that subjects give informed consent for their
participation.
The University appreciates your patience in awaiting the completion of this thorough review of
the allegations you raised.
Sincerely,
M A T K I t o U ^ k y ^^
MarkB.Rotenberg ̂
General Counsel
MBR: mwl
Attachment
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UN IVERS ITY OF M IN NES OTA
Office of the Generul Counsel 360 McNamara Ahmmi Center
200 Oak Street S.E.
M inneapolis, MN 55455
Office: 612-624-4100
Fax: 612.626-9624
February 11,2011
Mr. Mike Howard
9876 Hamlet Lane S.
Cottage Grove, Minnesota 55016
Re: Complaint of Misconduct against S. Charles Schulz, M.D.
Dear Mr. Howard:
The Board of Regents has asked me to respond to various allegations you raised
in a complaint submitted to the Board in December 2009 against Dr. S. Charles Schulz,
Head of the Department of Psychiatry in our Medical School. This letter summarizes the
University's extensive review process and our findings.
Your allegations against Dr. Schulz were evaluated under the following
University policies and procedures: Academic Misconduct, Individual Conflicts of
Interest, Disclosing Individual Health Information for Activities Preparatory to
Research, and Code of Conduct. Because the Code of Conduct is intended to reflect other
University policies and "does not create any different or additional rights or duties"
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Mr. Mike Howard
F ebruary 11, 2011
Page 3
Allegation 5. Dr. Schulz allegedly committed wrongdoing because he was
untruthful in a 2008 deposition in a civil lawsuit when he failed to mention his earlier
study on akathisia.
University Finding. There is no University policy violation by Dr. Schnlz based
on this deposition response, and there is no factual basis to find his response was
un truthful. In his deposition, he was asked what the term akathisia means; he responded
with a straightforward explanation. He was not asked whether he had published any
papers on akathisia or what were the finding of his papers. The 1992 paper described
akathisia as a "syndrome of motor restlessness" (Compr Psychiatry: 33(4) at 233), which
is similar to the description provided by Dr. Schulz in his deposition.
Allegation 6. Dr. Schulz allegedly violated the rights of patients because he stated
in a 2008 deposition in a civil lawsuit that he does not always inform patients of his
relationships with industry.
University Finding. There is no University policy violation by Dr. Schulz based
on this deposition response. The relevant exchange in the deposition asked about Dr.
Schulz's opinion, not his personal practices, regarding disclosure to patients. The
University's review of Dr. Schulz's compliance with his conflict management plan of
2007 shows that he made the required disclosures of his Scientific Advisory Board role at
AstraZeneca to the research subjects in an Astra Zeneca funded trial.
Allegation 7. Dr. Schulz allegedly breached the confidentiality rights of patients
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Mr. Mike Howard
February 11,2011
Page 4
University Finding. There is no University policy violation or other improper
conduct by Dr. Schulz in connection with his CME presentations. When Dr. Schulz gave
CME presentations about antipsychotic drugs, his focus was not limited to a particular
drug, consistent with CME guidelines that require balanced presentations. His
presentations were directed primarily at other mental health professionals, not primary
care providers, and he has not recommended Seroquel for uses other than very serious
psychiatric conditions.
Allegation 9. Dr. Schulz allegedly committed wrongdoing by conducting clinical
trials that force subjects to go off established drugs and potentially receive a placebo in
order to promote a drug.
University Finding. There is no University policy violation or other improper
conduct by Dr. Schulz based on his participation in placebo controlled drug studies.
Dr. Schulz did not participate in Study 41 because no subjects were enrolled at the
University. He served as a co-author but not investigator for Study 132 which was
conducted internationally. The use of a placebo controlled study is a widely recognized
and approved scientific standard for studies evaluating extended release forms of
approved drugs for approved indications of the drug. There is no evidence that Study 132
violated applicable scientific or regulatory standards related to use ofplacebos.
2007 Conflict Management Plan. In addition to investigating the allegations in
your complaint, the University also examined Dr. Schulz' compliance with his 2007
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U N I V E R SI T Y O F M I N N E SO TA
Offiw of the General Counse 360 McNamwa Alumni Center
200 Oak Street S.E.
Minneapolis, MN S54S5
Office: 612-62-1-4100
February7 2011̂ 6?.-626-9624
Carl Elliott, Professor
Dianne Bartels, Assistant Professor
J oan Liaschenko, Professor
Mary Faith Marshall, Professor
J ohn Song, Associate Professor
Leigh Turner, Associate Professor
Susan Craddock, Associate Professor
J oan Tronto, Professor
Center for Bioethics
N 504 B oynton
410 Church Street SE
Minneapolis, MN 55455-0346
Dear Professors Elliott, Bartels, L iaschenko, Marshall, Song, Turner, Craddock, and Tronto:
I have been asked by the Chair of the Board of Regents to supplement the response he provided
today to your letter of November 29,2010, At the Board's request, my office has reviewed the facts
and circumstances surrounding the CAFE research study and the suicide of Dan Markingson to
which you refer in your letter. Based on the examinations of this case already conducted by the
U.S. Food and Drug Administration (PDA), the Hennepin County District Court, and the Minnesota
Board of Medical Practice, assisted by the Minnesota Attorney General's office, the Board of
Regents determined that further University resources should not be expended re-reviewing this
matter.
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February 7, 2011
Page 2 of 3
Your letter to the Board of Regents suggests that this case may illustrate "an alarming series of
ethical violations and lapses." Our response to the allegations in your letter are as follows:
1. "Recruiting a mentally ill, possibly incompetent subject into a research study, while he
was under an involuntary order."
The allegation that Mr. Markingson was improperly admitted into the CAFE study was reviewed by
the PDA, the District Court, and the Board of Medical Practice, and found to be completely without
merit. It must be understood that Mr. Marldngson was determined to be competent to consent to
treatment at the time he consented to participate in the study in the judgment of two courts and
independent evaluators. The District Court judge that ordered Mr. Maridngson's stay of
commitment and participation in the treatment plan specifically found that "the rights of
Respondent [Markingson] have been protected throughout these proceedings," and that "the Dakota
County Social Services Department has developed a plan for services to treat the Respondent's
mental illness which is agreeable to the Respondent." During that court proceeding, Mr.
Markingson appeared in person, was represented by counsel, and, as noted by the court, a Dakota
County case manager recommended and endorsed Mr. Markingson's treatment program, In a
second, and separate, judicial proceeding, the Hemiepin County District Court specifically
addressed the allegation that Mr. Markingson had not provided his informed consent to participate
in the CAFE study, and dismissed that allegation "based on several undisputable facts."
2. "Large financial conflict of interest on the part of University researchers conducting the
study.
Both Dr. Olson. and Dr. Schulz received consulting fees from Astra Zeneca. Those amounts were
properly reported in the University's REPA system, and all University regulations were followed.
The University's examination of this allegation reveals no violation of existing conflict of interest
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February 7, 2011
P age 3 of 3
5. "The failure of University researchers to address the legitimate concerns of Mr.
Markingson's mother, Mary Weiss."
Ms. Weiss did express heartfelt concern for the welfare of her son. Her concerns not only were
heard at the tirrte, they were carefully reported in the record. However, the record also shows that
all of the mental health professionals involved in Mr. Markingson's treatment felt that he was
improving. His death was a tragic shock to his caregivers, including his social services case
manager and others not associated with the University. Notwithstanding Ms. Weiss' belief, there
simply is no evidence that Mr. Markingson's death was causally connected to his participation in
the CA F E study.
6. "The apparent development of a s