November 27, 2014

Attorney General Lori Swanson

Minnesota Attorney Generals Office
1400 Bremer Tower
445 Minnesota Street
St. Paul, MN 55101
Re: Whistleblower Niki Gjere & the Urgent Need to Investigate Psychiatric Research
Misconduct at the University of Minnesota Medical Center
Dear Attorney General Swanson:
On November 25, Fox 9/KMSP-TV aired an investigative report entitled Nurse questions integrity
of U of M drug researchers. The report featured an interview with Niki Gjere. Ms. Gjere is a
psychiatric clinical nurse specialist at the University of Minnesota Medical Center. In the newscast,
Ms. Gjere emerged as an institutional whistleblower calling for an investigation of her employer.
She disclosed valuable new information concerning the death of Dan Markingson and related
reports of psychiatric research misconduct. She also provided insight into the University of
Minnesotas stunning failure to investigate how Markingson was mistreated while he was a
research subject in the CAF study. Dr. Stephen Olson was the site principal investigator for this
trial and Markingsons psychiatrist. Dr. S. Charles Schulz, Chair of the University of Minnesota
Department of Psychiatry, was Olsons co-investigator.
Dr. Olson, Dr. Schulz, and senior university officials defending their conduct have repeatedly
claimed that Dan Markingson possessed decision-making capacity and was competent to choose
whether he wanted to participate in the CAF study. They have made these assertions despite the
substantial body of evidence indicating Dan Markingson had a serious mental illness, lacked insight
into his disease, and could not provide informed consent to participate in research.
During a court deposition, Dr. Olson denied that any Fairview employees expressed concerns about
whether Markingson was mentally competent to consent to participate in clinical research. He also
denied that Markingson was coerced into participating in the trial. Ms. Gjeres statements prompt
questions about the veracity of Dr. Olsons claims. Ms. Gjere stated, I raised issues. I had a
concern. Summarizing the concerns she expressed to Olson, she said, Its really difficult to say
that he can consent to a drug study with him being so ill and under the court commitment process.
Gjere added that other hospital employees informed her that they too were worried about Dan
Markingsons recruitment into the CAF study.

2
If Ms. Gjeres account is accurate, Dan Markingsons capacity to consent in a psychiatric clinical
study was a matter of great concern to some Fairview Hospital employees. At least one nurse, Ms.
Gjere, apparently shared these concerns with Dr. Olson while Dan Markingson was still alive.
Ms. Gjeres statements prompt several legal and ethical questions. Was a mentally ill, incompetent
research subject recruited into a clinical trial by wrongly classifying him as a consenting study
participant? Did Dr. Olson make a false statement during his deposition? If hospital staff had
concerns and shared their reservations, why did Markingson remain in the CAF study until he
committed suicide? Why has it taken a decade for it to emerge that health care providers directly
involved in Dan Markingsons care were worried about his decision-making ability and upset that
he was enrolled in the CAF study?
Senior university administrators have repeatedly demonstrated their unwillingness to address such
questions in a responsible and credible manner. The FDA employee who visited the University of
Minnesota Medical Center (Fairview-Riverside) and completed an inspection report after
Markingsons death did not speak to Dan Markingsons family members. She also failed to
interview health care providers who had concerns about Markingsons decision-making capacity.
At this late date, after failing to conduct competent investigations, it is unrealistic to think that
either the University of Minnesota or the FDA are going to provide meaningful answers to these
important questions. You need to investigate them. Justice delayed is better than justice denied.
In her interview, Ms. Gjere expresses serious concerns about whether the clinical research
imperative took precedence over providing individually attuned medical care to vulnerable patients.
According to Gjere, it was part of the culture then, that its research at all costs. She added, It
was as though research was taking precedent over having them get better and having them receive
the care they need to improve their symptoms, to improve their quality of life.
Gjere states that aggressive recruiting tactics were used to recruit vulnerable patients into
psychiatric clinical trials. These strategies were reportedly a matter of great concern to psychiatric
nurses. Gjere also claims that a culture of fear prompted Fairview Hospital employees to remain
silent despite their reservations about how patients with serious mental illnesses were being
badgered and pressured. This institutional culture is reportedly so pervasive that Gjere now fears
she will lose her job as a result of coming forward as a whistleblower. She states, You dont speak
against the university and not pay somehow.
Gjeres comments concerning the pressure to enroll trial subjects raise serious legal and ethical
questions. Have University of Minnesota Medical Center psychiatrists used aggressive recruitment
tactics when trying to find research subjects for their studies? Has the research imperative taken
precedence over ensuring that patients receive care tailored to their particular circumstances? Have
undue inducements or coercive measures such as recruiting mentally ill individuals subject to civil
commitment orders been used to recruit study subjects at Fairview? Are financial and institutional
pressures to recruit study subjects so intense that legal and moral lines were crossed?
Psychiatrists and senior administrators at the University of Minnesota have dodged these questions
for a decade. None of these individuals were willing to go on camera and respond to Mr. Baillons
questions. No one is holding them accountable and demanding meaningful answers to these

3
questions. You need to investigate and determine whether University of Minnesota psychiatrists
and the administrators defending them have violated laws and ethical standards governing clinical
research involving vulnerable individuals.
According to President Kaler, General Counsel William Donohue, Vice President Brian Herman,
and other senior university and hospital administrators, Dan Markingsons death was thoroughly
investigated and there is no need for additional enquiries. In fact, there is no evidence that
Markingsons death was ever investigated in anything other than a superficial and self-exonerating
manner. In the Fox 9 investigative report, Ms. Gjere states, Ive never been asked about Dans
time or recruiting. Ive been telling people about it but Ive never been asked. Challenging the
Universitys repeated claim that the Markingson case was thoroughly examined, Ms. Gjere said,
Its not true, its not been investigated. Nobody there talked to hospital staff about anything.
University of Minnesota officials have had a decade to investigate Dan Markingsons death and
related allegations of psychiatric research misconduct. Ten years have passed and it appears they
never even spoke to hospital employees directly involved in Markingsons care.
Senior university administrators claims that they investigated psychiatric research misconduct are
thoroughly discredited. There was no investigation. Claims to the contrary are false. You need to
conduct an independent investigation and determine whether university psychiatrists and their
institutional defenders have violated any laws. You have already investigated unfair billing
practices at Fairview. Reports of deaths, injuries, and research misconduct involving vulnerable
patients are even more deserving of your scrutiny than claims about predatory billing.
University officials like to emphasize that Dan Markingson died ten years ago. They claim his case
is old news. However, if the numerous local citizens that have contacted Professor Carl Elliott
and me are credible, and I believe they are, Dan Markingson is one person among numerous victims
of psychiatric research misconduct. Some of these victims reportedly were harmed after
Markingsons death. Perhaps treating Markingsons death in the CAF study as ancient history not
worth revisiting has enabled more patients to be harmed. Niki Gjere has the same concern. Asked
by Mr. Baillon about her greatest fear in the current environment, she responded, That it
continues to happen. That patients are continuing to be harmed, that nothings been fixed.
Responsible university presidents investigate reports of research misconduct. Unfortunately,
President Kaler functions more as a college mascot a Goldy Gopher in a suit and tie than as an
accountable leader. The University of Minnesota is never going to conduct an honest and thorough
investigation of alleged psychiatric research misconduct. You need to do it. Any additional delays
risk putting more vulnerable individuals at increased risk of harm.
Yours sincerely,

Leigh Turner, PhD

Associate Professor
University of Minnesota Center for Bioethics

4
cc: Senator Terri E. Bonoff, Chair, Higher Education & Workforce Development Committee
Representative Gene Pelowski Jr., Chair, Higher Education Finance
Arne H. Carlson, Former Governor of Minnesota
Professor Carl Elliott, University of Minnesota Center for Bioethics
Niki Gjere, Psychiatric Clinical Nurse Specialist, University of Minnesota Medical Center