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Accountability in Research

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ISSN: 0898-9621 (Print) 1545-5815 (Online) Journal homepage: http://www.tandfonline.com/loi/gacr20

Institutional Pathology and the Death of Dan


Markingson
Carl Elliott M.D., Ph.D.
To cite this article: Carl Elliott M.D., Ph.D. (2016): Institutional Pathology and the Death of Dan
Markingson, Accountability in Research, DOI: 10.1080/08989621.2016.1246969
To link to this article: http://dx.doi.org/10.1080/08989621.2016.1246969

Accepted author version posted online: 18


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Date: 17 November 2016, At: 12:40

ACCOUNTABILITY IN RESEARCH
http://dx.doi.org/10.1080/08989621.2016.1246969

Institutional Pathology and the Death of Dan Markingson


Carl Elliott, M.D., Ph.D.
Center for Bioethics, University of Minnesota, Minneapolis, Minnesota, USA
ABSTRACT

KEYWORDS

In the spring of 2015, 11 years after a mentally ill young man


named Dan Markingson stabbed himself to death in an industrysponsored drug study, officials at the University of Minnesota
suspended recruitment of subjects into drug trials in its
Department of Psychiatry. University officials agreed to act only
after a scathing investigation by Minnesota Office of the Legislative
Auditor found damning evidence of coerced recruitment, inadequate clinical care, superficial research oversight, a web of serious,
disturbing conflicts of interest, and a pattern of misleading public
statements by university officials aimed at deflecting scrutiny. In
this article, I examine the larger institutional factors leading up to
Markingsons suicide and prevented corrective action for so long.

Conflict of interest; human


subjects ethics; human
subjects regulation and
oversight; informed consent;
misconduct in research;
organizational and
institutional ethics; research
ethics; research ethics in
university contexts; research
on the mentally ill;
vulnerable populations

In the spring of 2015, after years of withering public criticism, officials at the
University of Minnesota suspended recruitment of subjects into drug trials in its
Department of Psychiatry (Perry 2015). It was not a willing concession. University
officials agreed to act only after the Minnesota Office of the Legislative Auditor
released a scathing investigation into the violent suicide of Dan Markingson, a
research subject in an industry-sponsored drug study at the university. The
Legislative Auditors report presented damning evidence of coerced recruitment,
inadequate clinical care, superficial research oversight, a web of serious, disturbing
conflicts of interest, and a pattern of misleading public statements by university
officials aimed at deflecting scrutiny (OLA 2015).
This powerful indictment came only three weeks after another blistering review
of research oversight at the university. That review was commissioned at the
request of the universitys Faculty Senate in response to a letter organized by
Trudo Lemmens at the University of Toronto and signed by 175 scholars in
bioethics and related disciplines. It found a broad range of unsettling problems
with the universitys human research protection program, including shoddy
scientific review and little attention to the risks of studies, as well as a culture of
fear in the Department of Psychiatry (AAHRPP 2015).
Almost as alarming as Markingsons suicide was the fact that it took nearly
11 years for the university to respond in any meaningful way. University officials
refused to undertake a legitimate investigation of Markingsons deathor even
CONTACT Carl Elliott
ellio023@tc.umn.edu
Center for Bioethics, University of Minnesota, N504 Boynton,
410 Church St SE, Minneapolis, MN 55455-0346, USA.
2017 Taylor & Francis

C. ELLIOTT

debate it publiclydespite years of disturbing news reports, campus activism,


external pressure from bioethics scholars, and the intervention of a former
Minnesota governor. Even when new cases of research misconduct emerged,
the university did not budge.
No one should be surprised by this. When human subjects in research
studies are mistreated, it is the norm rather than the exception for institutional officials to deny wrongdoing and downplay the harm. In fact, in the
decade preceding Markingsons suicide, the University of Minnesota had
seen an alarming number of serious research scandals, including the disqualification of two faculty members in the Department of Psychiatry by the
FDA for separate episodes of research misconduct, yet it had taken little
action to remedy its underlying structural problems.
Like many other institutions, University of Minnesota officials have
defended the university by attempting to portray the issue as an isolated
incident from the distant past. But problems this serious are rarely the fault
of a single person. If there are lessons to be learned from the Markingson
case, they must include the larger institutional shortcomings that permitted
unethical conduct to thrive.

Dan Markingsons suicide


On November 12, 2003, Dan Markingson was admitted to a locked psychiatric unit at the University of Minnesotas Fairview Hospital.1 A 26-year old
native of St. Paul, Minnesota, Markingson had first started to experience
symptoms of psychosis the previous summer, when he was living in Los
Angeles. He was convinced that he had been visited by aliens and that he was
being called upon to commit mass murder as part of an apocalyptic storm.
Im especially eager to attend this storm and SLAY those who deserve
slaying, he wrote in emails. Eventually his mother, Mary Weiss, became so
alarmed that she called the police.
Markingson was admitted to Fairview Hospital by Dr. Stephen Olson, the
head of the universitys schizophrenia program. Olson believed that
Markingson was psychotic, potentially dangerous, and incompetent to
make a decision about whether to take antipsychotic drugs. He prescribed
an antipsychotic, risperidone (Risperdal), and on November 14, recommended that Markingson be involuntarily committed to a state psychiatric
institution. On November 17, 2003, a county judge signed a civil commitment order confining Markingson to a locked ward at Fairview University
Medical Center. Markingson was later seen by two other clinicians as part of
the commitment process, each of whom noted Markingsons extremely
disordered thinking (Geister 2003; Jacobson 2003).
1

This narrative is taken from Elliott (2010) and Office of the Legislative Auditor 2015.

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On November 20, Olson asked a county court to grant Markingson a stay


of commitment. Under the conditions of a stay, patients can avoid physical
confinement in a locked unit, but only if they agree to comply with the
recommendations of the treatment team. Ordinarily, compliance means
standard psychiatric treatment. But on November 21, only a day after the
stay was granted, Olson asked Markingson to enroll in an industry-funded
clinical trial of atypical antipsychotic drugs. Jean Kenney, a study coordinator, had Markingson sign a consent form for the study when his mother was
not present. When Mary Weiss learned of her sons enrollment in the trial
she objected vehemently, but her objections were ignored.
The antipsychotic trial, which was called the CAF Study (Comparison of
Atypicals in First-Episode Psychosis) was a 26-site, double-blind, year-long
comparison of three different atypical antipsychotic drugs: quetiapine
(Seroquel), olanzapine (Zyprexa), and risperidone (Risperdal). Stephen
Olson was the principal investigator for the Minnesota site, while
Dr. Charles Schulz, the Chair of the Department of Psychiatry, was a coinvestigator. The CAF study was sponsored by AstraZeneca, the manufacturer of Seroquel.
After two weeks, Markingson was discharged to Theo House, a residential
facility for the mentally ill in St. Paul. Upon his discharge, Markingson was
required to sign an aftercare agreement stating that he understood that he
could be returned to involuntary confinement if he failed to keep his CAF
study appointments or did not continue to take his study medication.
Over the course of Markingsons five months in Theo House, Mary Weiss
tried repeatedly to have him removed from the CAF study. She was convinced
his condition was deteriorating. At one point, Markingson told his mother that
people were speaking to him through the television. A social work note on
March 26 stated that Dans thoughts were still delusional and grandiose. Weiss
felt that Markingson was becoming increasingly agitated and tense, as if he were
going to explode any minute.
Mary Weiss warned the research team of her concerns. She wrote five detailed
letters to Olson and Charles Schulz, explaining her worries. All of her letters went
unanswered except for one; Schulz wrote that it was not clear to me how you
thought the treatment team should deal with this issue (Elliott 2010). On
April 11, 2004, Weiss left a distraught voice mail message for the study coordinator, Jean Kenney, asking Do we have to wait until he kills himself or anyone
else before anyone does anything?
Three weeks later, Markingson committed suicide. Early on the morning
of May 8, 2004, his corpse was discovered in a bloody bathroom at Theo
House, the head nearly severed from the body and the torso slit from throat
to groin. Markingson had mutilated himself with a box-cutter. On the nightstand was a suicide note, which read, I left this experience smiling. A
toxicology report later revealed that he had been taking Seroquel.

C. ELLIOTT

Institutional responses
Markingsons death first came to public attention in May 2008, when The
St. Paul Pioneer Press published an investigative report by Paul Tosto and
Jeremy Olson 7 (Tosto and Olson 2008). Although subsequent investigations
would reveal a number of troubling issues, the most fundamental problem was
identifiable from the start. Markingson was an extraordinarily vulnerable
patient: floridly psychotic, hospitalized on a locked unit, recruited over the
strenuous objections of his mother, and subject to a civil commitment order
that legally compelled him to comply with the recommendations of his
psychiatrist.
The Institutional Review Board (IRB) was notified of Markingsons death,
but it did not conduct any investigation apart from a routine continuing
review. In 2005, the FDA investigated at the request of Mary Weiss and
issued an Establishment Inspection Report (a comprehensive record of the
investigation), but Sharon Matson, the inspector, dismissed any suggestion
that Markingsons decision-making capacity was impaired. She noted
Markingsons civil commitment order only in passing and failed to mention
the influence that the threat of involuntary confinement might have had on
his consent. Matson concluded, There was nothing different about this
subject than the others enrolled to indicate that he couldnt provide voluntary informed consent (Matson 2005).
Mary Weiss eventually filed a lawsuit. Yet a Hennepin County judge
dismissed her suit against the university, ruling that the University of
Minnesota, as a state body, was statutorily immune from lawsuit. This ruling
meant that no matter what the merits of the case, the university could not be
sued. The judge did allow a malpractice suit against Olson, which was settled
out of court for $75,000 (OLA 2015).
University officials took no action when the Pioneer Press report appeared,
and they did not comment a year later when the state legislature passed a bill
(Dans Law) placing serious restrictions on the recruitment of patients under
civil commitment orders into psychiatric drug studies (Laws of Minnesota 2009;
Olson 2009a). By 2009, however, another troubling issue had emerged.
AstraZeneca was facing federal litigation for fraudulent marketing of quetiapine
(Seroquel). As documents from the litigation were unsealed, it was becoming
evident not only that AstraZeneca had manipulated and buried research studies
in order to promote Seroquel, but also that Charles Schulzan AstraZeneca
consultant and a co-investigator on the CAF studyhad been involved. Schulz
had promoted suspect Seroquel studies in company press releases, even as
internal AstraZeneca emails referred to a smoke and mirrors job to hide
Seroquels serious metabolic side-effects (Moore and Lerner 2009; Mannix
2011). In 2010, AstraZeneca paid $520 million to settle federal fraud charges.
Later that year I wrote about the links between the Seroquel fraud and the

ACCOUNTABILITY IN RESEARCH

Markingson case in Mother Jones, citing the opinion of several psychiatric


researchers that the CAF study had been designed to produce positive results
for Seroquel (Elliott 2010).
In November 2012, the Minnesota Board of Social Work issued a corrective action against the CAF study coordinator, Jean Kenney (State of
Minnesota Board of Social Work 2012). The Board found that Kenney had
attempted to perform medical tasks well beyond her competency, had failed
to respond to the voice mail messages left by Mary Weiss, and had failed to
inform Markingson of the new metabolic risks of Seroquel when the study
sponsor notified investigators. She also routinely signed study charts with the
initials of a physician. Again, the university took no action, saying Kenney
was no longer an employee.
In 2013, I obtained university documents that revealed a previously hidden
conflict of interest (Elliott 2013). The IRB panel overseeing the CAF study had
been chaired by David Adson, a colleague of Schulz and Olson. Not only was
Adson the director of the research clinic in which the CAF study was managed,
he was also the recipient of over $149,000 in consulting, research, and speaking
fees from AstraZeneca, the sponsor of the study. According to the state pharmacy board, Adson had received $5,200 as compensation for services in 2004,
the year in which Markingson died, and $16,884 more the next year. In total,
Adson received over $650,000 in from the pharmaceutical industry from 2002 to
2010. Two years later, the Legislative Auditors report would reveal that Adson
had also served as a confidential outside investigator for the Minnesota Board of
Medical Practice, advising it to dismiss a complaint about Olsons treatment of
Markingson (OLA 2015; Baillon 2015b).
These were not the first concerns to arise about conflicts of interest.
According to The Pioneer Press, Olson and Schulz had both received large
speaking and consulting fees from the pharmaceutical industry (Tosto and
Olson 2008). In addition, the CAF study recruitment payments were weighted
such that sites had a financial incentive to keep subjects in the study as long as
possible. Email correspondence from the 2005 lawsuit showed that Quintiles, the
CRO managing the study, had pressured the CAF study team to recruit
subjects aggressively (OLA 2015).
None of these findings persuaded oversight bodies to review the case. External
entities such as the Office of Human Research Protection and the Association or
the Accreditation of Human Research Protection Programs declined to investigate, as did university offices such as the IRB Executive Committee, the Research
Subject Advocate, and the Research Ethics Consultation Service.
By 2014, an investigative report by KMSP News made it clear that the
problems in the Department of Psychiatry were not limited to the case of
Dan Markingson. In July 2007, a patient named Robert Huber had been seen
at Fairview Hospital by Dr. Stephen Olson, who gave him a diagnosis of
paranoid schizophrenia, confined him to a locked unit under a 72-hour

C. ELLIOTT

emergency hold, and asked him to enroll in a study sponsored by Solvay


Pharmaceuticals. Solvay was testing an experimental antipsychotic called
bifeprunox. Immediately, they were on me to do experimental medications,
non-FDA approvedand I had never been on medications in my life,
Huber told KMSP News. Then, they say you have a giant medical bill and
if you do the research, you wont have this giant medical bill (Baillon 2014).
Huber did so poorly on bifeprunox that he began to consider suicide. He
went to the emergency room three times with abdominal pain, but his
complaints were dismissed as psychosomatic. In early August, the FDA
rejected bifeprunox for marketing approval, citing lack of efficacy as well as
the death of a research subject in Europe from hepatorenal failure (New York
Times 2007). But Olson did not inform any of the research subjects that the
drug had been rejected (Dykhuis 2015a). Huber eventually dropped out of
the study. In January, Solvay suspended all bifeprunox studies after an
independent pathology report concluded that the drug had most likely
caused the death of the subject in Europe.
In March 2014, I filed a complaint about the bifeprunox study with the
University of Minnesota IRB. Robert Huber filed a separate complaint. Brian
Herman, the Vice-President for Research, hired a private firm, FTI Consulting,
to review the case in parallel with an investigation by the IRB Executive
Committee. When the response to our complaints finally came over a year
later, it admitted only minor problems with the study and declined to sanction
Olson. A letter to Huber stated, You were not pressured or coerced to enroll in
this study (Dykhuis 2015b). A year later, a separate investigation by the Office
of Research Compliance came to the same conclusion (Webb 2016). At no point
was Huber interviewed about his experience (Dykhuis 2015a).
Institutional pathology
Many scholars argue that medicine lags behind other professions and industries in
addressing its own faults honestly and fixing the safety problems that can put
people in danger (Carroll, Rudolph, and Hatakenaka 2002; Hudson 2003). A
report by the Institute of Medicine commissioned in the wake of the cancer
genomics scandal at Duke University pointed out that academic medical centers
have strong incentives to refrain from investigating allegations of research misconduct (Michael, Nass, and Omenn 2012). The reasons are obvious: loss of grant
funding, negative publicity, reputational blows, and of course, the possibility of
litigation. Even when academic medical centers do investigate misconduct, as the
authors of a recent Cochrane Library report noted, they often keep the results
secret (McCook 2016).
In 2005, a group at the University of Colorado at Denver convened a workshop on the culture of medical research, inviting representatives from other
fields to compare recent academic research scandals with their own experiences

ACCOUNTABILITY IN RESEARCH

dealing with industry disasters and safety issues. Participants included leaders
from the aviation, meat production and nuclear power industries, as well as a
representative from the judiciary and two communications specialists in crisis
management. A report on the workshop in Academic Medicine stressed several
points relevant to the Markingson case (Yarborough et al. 2009).
First, participants agreed that in most fields, adverse events are typically the
result of system-wide institutional failures. They are often preceded by a series of
cascade effects, some of which may seem trivial until they result in serious
problems. Second, participants agreed that compliance with laws and regulations
should be seen as a bare minimum and not as a substitute for an institutional
culture of honesty and ethics. (As one participant said, You can follow all the
rules and still not get it right.) Third, when adverse events occur, restoring public
trust depends on genuine humility and willingness to look at mistakes, rather than
mere public relations messages. Fourth, participants agreed that it is crucially
important not only to restore public trust, but to develop trust and good relationships within the institution itself. As one participant pointed out, More than 90%
of infractions reported are reported from within.
At the University of Minnesota, evidence of system-wide institutional failure
had become apparent years before Markingsons suicide. In 2000, the FDA
disqualified James Halikas, a faculty member in the Department of Psychiatry,
for recruiting illiterate Hmong opium addicts into a risky study of GHB, a CNS
depressant, without their consent (Sherman 2000, Rigert and Lerner 1993b). Just
three years before the Halikas episode, the FDA had disqualified his colleague,
Barry Garfinkel, the Head of Child Psychiatry, for research fraud (HHS 1997).
Garfinkel was sent to federal prison (Rigert and Lerner 1993a). In 1998, the
Minnesota Board of Medical Practice sanctioned Dr. Faruk Abuzzahab, a clinical
faculty member (and former full-time member) of the Department of
Psychiatry, for the deaths of five patients under his care and the injuries of fortyone others. Seventeen of these patients had been research subjects in clinical
trials Abuzzahab had conducted.
Most notoriously, the university was hit with sanctions by the National
Institutes of Health and the U.S. Department of Justice in the 1990s for the
illegal sales of an experimental immunosuppresent drug. According to the
Department of Justice, the University of Minnesota illegally profited by
selling an unlicensed drug (ALG), failed to report to the National Institutes
of Health (NIH) income from selling the drug, improperly tested the drug on
patients without their informed consent, and inflated billings on 29 federal
grants (U.S. Department of Justice, 1998).
University of Minnesota officials did not treat these episodes as signals
of institutional dysfunction. In fact, when the Garfinkel fraud case was
being investigated, according to the Star Tribune, university officials hid
the results of a university investigation from federal investigators for
nearly four years (Rigert and Lerner 1993a). As the controversy over the

C. ELLIOTT

Markingson case escalated, university officials simply issued blanket


denials, claiming repeatedly that the university had already been investigated and exonerated. It was this insular and inaccurate response that
was highlighted by the Minnesota Office of the Legislative Auditor as the
single most disturbing aspect of the Markingson scandal. We are especially troubled by the response of University leaders to the case, James
Nobles wrote. (T)hey have made misleading statements about previous
reviews and been consistently unwilling to discuss or even acknowledge
that serious ethical issues and conflicts are involved (OLA 2015).
In fact, the response went well beyond misleading statements about previous reviews. First, university officials insisted that what many others saw as
mistreatment of research subjects was not really wrong at all.
Mr. Markingsons suicide was a tragedy, but it is not a scandal, wrote
Aaron Friedman, Vice-President for Health Sciences and Dean of the
Medical School, in a 2013 editorial. Nine years later, it is time to stop
blaming our university and our researchers (Friedman 2013). This message
was reinforced privately to faculty members in the Department of Psychiatry
(I want to commend you all, Friedman wrote to them in 2011, adding I
can only imagine the extra stress your department has been under) and
publicly by almost every university official who commented on the
Markingson case (Friedman 2011).
This pattern extended beyond misconduct in research. Both of the external
reviews released in 2015 emphasized the role that financial conflicts of interest
have played in the universitys shortcomings. But for years, university leaders sent
unambiguous messages stressing that they did not consider financial conflicts to
be a problem. In 2009, the Finance Committee of the United States Senate
investigated Dr. David Polly, the chair of spine surgery, for failing to disclose
nearly $1.2 million in consulting fees from a medical device company. An internal
investigation found that Polly had violated university policy. Yet not only did
university officials decline to discipline Polly; they permitted him to continue
serving on the universitys conflict of interest committee. When Pollys service
became public, university officials defended the choice, saying that it was essential to have industry consultants such as Polly on the committee (Moore 2009).
University leaders responded similarly when Charles Schulz, the Chair of
the Department of Psychiatry, was first linked to the AstraZeneca fraud
scandal. Frank Cerra, the Vice-President for Health Sciences, defended
Schulz in the Star Tribune by emphasizing that he considered it the proper
role of a university professor to engage with the pharmaceutical industry
(Moore and Lerner 2009). The Pioneer Press reported that the dean of the
medical school, Dr. Deborah Powell, is aware of the controversy over Schulzs
research and has offered him her full support (Olson 2009b). In fact, Powell
herself was no stranger to scandal; in 2007, she came under fire for her

ACCOUNTABILITY IN RESEARCH

service as a board member for Pepsi Americas, earning nearly $100,000


a year (Tosto 2007).
Second, even as scandals and public embarrassments emerged, university
officials quietly encouraged faculty and staff members to develop a high
tolerance of risks in the pursuit of research and scholarship. In June 2010,
less than a year after the Senate Finance Committee announced its investigation of David Pollys hidden conflicts of interest, the Board of Regents heard
a presentation from the leader of the Risk Tolerance Working Group, a
body led by Vice-President for Research Tim Mulcahy which also included
Center for Bioethics director Jeff Kahn and university auditor Gail Klat
(Mulcahy 2010). Mulcahy recommended loosening the universitys conflict
of interest policy, telling the Regents that the culture of the university had
become far too risk-averse. President Eric Kaler reinforced this message in
his 2013 State of the University address, arguing that the university should
not impose needless administrative burdens on faculty members simply
because were afraid a misdeed of two decades ago will reappear again.
Kaler said, If [university policies] are excessively burdensome, going beyond
what the feds or other entities require us to do, we should change them or
at least make a conscious decision not to (Kaler 2013).
Third, University of Minnesota officials rarely sanction wrongdoers. This has
been the rule in the Markingson, Huber, and Polly cases, of course, but it extends
well beyond those three examples. In 2004, for example, the Star Tribune
reported that Leo Furcht, the Chair of Laboratory Medicine and Pathology,
had secretly steered a $501,000 research grant to his own biotech company,
which he later sold for $9.5 million, most of it in personal profit. The scheme
violated university policy, as an internal investigation found. Yet the Dean of the
Medical School, Deborah Powell, kept the entire affair hidden, gave Furcht only
minor sanctions, and appointed him to direct a major ethics task force (Moore,
Lerner, and Marcotty 2008).
Finally, the university has been unusually aggressive in attacking its critics,
especially research subjects and their families. The result, of course, is fear.
When Robert Huber spoke to KMSP News, for example, the Academic
Health Center communications director, Brian Lucas, attempted to discredit
him. Lucas and Stephen Olson released a statement to KMSP that read in
part: (Hubers) medical record shows extreme anxiety and paranoia, a
history of head injuries and lengthy battle with alcoholism. It is highly
inappropriate for him to be put in the media spotlight as a spokesperson
for clinical trial safety (Baillon 2014).
Even more aggressive were the measures taken by university attorneys
against Mary Weiss, the mother of Dan Markingson. In 2008, when the
Hennepin County court ruled that the University of Minnesota was statutorily immune from lawsuit, university attorneys responded with a legal action
against Mary Weiss called a notice to assess costs. In that notice, the

10

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university demanded that Weiss pay the university $57,000 to compensate it


for its legal expenses. The university later agreed to drop the demand, but
only if Weiss gave up her right to appeal the immunity ruling (OLA 2015;
Elliott 2010).
Actions such as this send a powerful messagenot just to patients, but to
faculty and staff members. When the AAHRPP external review of research
oversight at the university was released in February 2015, it included a
chilling assessment of the culture of fear in the Department of
Psychiatry. According to the report, psychiatric staff members provided
stories of intimidation by researchers and fear of retaliation should staff
voice opposition to practices that were of concern (AAHRPP 2015).
Several months later, a second internal investigation found that many hospital staff members expressed a profound distrust of some psychiatric
researchers (Friedrich 2015). This could not have been a complete surprise
to the university administration; in 2006, an audit had found that nearly 40%
of staff members did not believe they would be protected from retaliation if
they blew the whistle on research misconduct (Tosto 2008).
Conclusion
In May of 2015, University of Minnesota officials announced a plan to remedy
the problems identified by the two external investigations. At a cost of
$8 million, the plan included a new records system, revisions to a number of
university policies, a proposal to pay IRB members, a new course in research
ethics, a research ethics conference, and a statement of core commitments
intended to cultivate a culture of ethics at the university (Olson 2015). Steve
Miles of the Center for Bioethics, a member of the team that developed the
reform plan, called it the most robust policy Ive ever seen in 34 years of
teaching medical ethics (Kaler 2015). He said it was Markingsons legacy.
The plan did not include sanctions against any faculty member or university
official. It did not reverse any previous decisions by the IRB or any other university
body, nor did it correct any of the misleading statements identified by the
Legislative Auditor. The plan did not address the universitys failures of transparency, such as its unwillingness to cooperate with open records requests. Critics of
the administration were excluded from the three continuing oversight
committees.
The results have been predictable. In May 2015, the New York Times
reported another controversial AstraZeneca study conducted by Charles
Schulz, who had recently retired as Chair of the Department of Psychiatry
(Thomas 2015; TPT Almanac 2015). Schulz had enrolled two residents of a
sex offender facility in a study of quetiapine (Seroquel) for Borderline
Personality Disorder, one of whom had slipped his study medication into
the oatmeal of the staff and inmates at the facility. According to the Times,

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11

this event did not seem to ruffle the university oversight board that is
charged with looking into such episodes. Questions were also raised about
the eligibility of the subjects for the study and the status of the sex offender
facility as a recruitment site. Schulz was not sanctioned.
Two months later, Kenneth Winters, a senior faculty member in the
Department of Psychiatry, admitted to forging a federal Certificate of
Confidentiality for adolescents in a study sponsored by the National
Institute for Drug Abuse. According to news reports, the university declined
to sanction him for forging the document and instead offered him the
opportunity to retire (Baillon 2015a).
In February 2016, eight months after the reform plan was announced, the
results of yet another investigation of the Department of Psychiatry were
released (Clinical Research and Compliance Consulting 2015). That investigation found over forty critical violations of research and safety guidelines, as well
as admissions by staff members that they altered study documents when they
prepared for audits. We go behind the scenes and fix things up, one interviewee said. The consultant who conducted the investigation reported being
intimidated and verbally abused by department faculty members. Even more
alarming, university officials attempted to suppress the report while it was still in
progress, telling the consultant not to put any of her findings in writing. When
the report was leaked to the press, university officials disputed the findings and
dismissed its significance (Lamkin and Elliott 2016; Olson 2016).
University leaders have attempted to portray the universitys research
scandals as an issue of faulty policies and rules. But as repeated external
reviews have made clear, the problems at the University of Minnesota go well
beyond its policies. For decades, the universitys Academic Health Center has
had leaders who look the other way when rules are broken, who fail to
sanction those who break the rules, and who take harsh action against
those who dissent. The result is an institutional culture in which misconduct
is tolerated and opposition is widely seen as futile.
To change that culture, university leaders must convince patients, faculty,
staff, and students that they are truly committed to protecting the rights and
welfare of research subjects. This will require public apologies to victims of
research misconduct and sincere efforts to compensate them for their suffering. It will also require sanctions for those who violated the rights and
welfare of research subjects, as well as for the university officials who made
false and misleading statements or otherwise tried to cover up misconduct.
The leaders of any institution in which serious wrongdoing is revealed will
naturally try to minimize the reputational damage to the institution. Often
they are tempted to hide information, vilify critics, and protect guilty parties
who are seen as valuable to the institution. This strategy is tempting because
it so often works. The list of institutions that have confronted their own
medical research scandals honestly and openly is very short. Most

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institutions confronted with scandal simply count on the controversy to fade


away without any lasting harm.
That this strategy is deeply unfair to research subjects should go without
saying. That it did not succeed fully at the University of Minnesota is
testimony to the value of organized resistance. Purely as a matter of institutional self-interest, however, there are limits to the sheer number of serious
research scandals that an institution can endure. Few academic research
centers can survive without the trust of patients and potential research
subjects. And few public institutions of any sort can thrive without the
trust of the community that must support them politically and financially.

References
Association for the Accreditation of Human Research Protection Programs (AAHRPP). 2015.
An external review of the protection of human research participants at the University of
Minnesota with special attention to research with adults who may lack decision-making
capacity, February 23. http://research.umn.edu/advancehrp/documents/final_report.pdf
(accessed August 17, 2016).
Baillon, J. 2014. U of M drug study criticism grows. Fox 9 News (KMSP), May 19. http://
www.fox9.com/health/1647039-story (accessed August 16, 2016).
Baillon, J. 2015a. Another ethics scandal for the University of Minnesota Department of
Psychiatry. Fox 9 News (KMSP), July 15. http://www.fox9.com/news/2643102-story
(accessed August 16, 2016).
Baillon, J. 2015b. Mom denounces U of M research conduct. KMSP News (Fox 9), April 1.
http://www.fox9.com/news/investigators/1729731-story (accessed August 18, 2016).
Carroll, J. S., J. W. Rudolph, and S. Hatakenaka. 2002. Lessons learned from non-medical
industries: Root cause analysis as culture change at a chemical plant. Quality and Safety in
Health Care 11:26669. doi:10.1136/qhc.11.3.266.
Clinical Research and Compliance Consulting. 2015. University of Minnesota Department of
Psychiatry Assessment Report, December 31. http://research.umn.edu/advancehrp/docu
ments/UMN%20Dept%20of%20Psychiatry%20Assessment%20Report%20and%20CTSI%
20Mgmt%20Plan.pdf (accessed August 18, 2016).
Department of Health and Human Services (HHS), United States Food and Drug
Administration. 1997. Docket No. 94N-0011, Barry D. Garfinkel; Denial of hearing; Final
debarment order. http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/
ucm062105.htm (accessed August 17, 2017).
Dykhuis, D. 2015a. Human research protection program, letter to Carl Elliott, June 5. https://
www.scribd.com/doc/281844393/Debra-Dykhuis-Letter-to-Carl-Elliott-June-5-2015
(accessed August 17, 2016).
Dykhuis, D. 2015b. Human research protection program, letter to Robert Huber, May 6.
https://www.scribd.com/doc/264627742/Letter-from-Debra-Dykhuis-of-University-ofMinnesota-Research-Protection-to-Robert-Huber-regarding-bifeprunox-study-May
-6-2015.
Elliott, C. 2010. Making a killing. Mother Jones, 35 (5):5463.
Elliott, C. 2013. Getting by with a little help from your friends. Hastings Center Bioethics
Forum (blog), October 18. http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=
6582&blogid=140 (accessed August 16, 2016).

ACCOUNTABILITY IN RESEARCH

13

Friedman, A. 2011. Email to department of psychiatry, February 9. https://www.scribd.com/


doc/119073709/Note-of-Support-From-Aaron-Friedman-to-Department-of-Psychiatry
(accessed August 17, 2016).
Friedman, A. 2013. University of Minnesota research case is not a scandal. Star Tribune
(Minneapolis), May 16. http://www.startribune.com/university-of-minnesota-research-case
-is-not-a-scandal/207795501/ (accessed August 16, 2016).
Friedrich, A. 2015. Report: Deep distrust at Fairview over U psychiatry research. Minnesota
Public Radio News, May 11. http://www.mprnews.org/story/2015/05/11/internalinvestigation-uofm-fairview (accessed August 16, 2016).
Geister, K. 2003. Report of pre-petition screening team, re: Daniel Markingson, respondent,
November 17. https://www.scribd.com/doc/49730113/Pre-petition-screening-report
(accessed August 17, 2016).
Hudson, P. 2003. Applying the lessons of high-risk industries to health care. Quality and
Safety in Health Care December 12 (Suppl 1):i 712. doi:10.1136/qhc.12.suppl_1.i7.
Jacobson, J. 2003. Report of examiner. Dakota County Court File No. PX-03-10,
November 19. https://www.scribd.com/doc/49729697/Jacobson-Examiner-Report
(accessed August 17, 2016).
Kaler, E. 2013. State of the university 2013: The Minnesota way, February 28. https://
president.umn.edu/content/state-university-2013-minnesota-way accessed August 17,
2017).
Kaler, E. 2015. U is moving forward on research ethics. Star Tribune (Minneapolis), May 30.
http://www.startribune.com/counterpoint-from-eric-kaler-u-is-moving-forward-onresearch-ethics/305572061/ (accessed August 16, 2016).
Lamkin, M., and C. Elliott. 2016. Star Tribune (Minneapolis). University of Minnesota research
lapses show self-reform is failing, February 11. http://www.startribune.com/university-ofminnesota-research-lapses-show-self-reform-is-failing/369355421/ (accessed August 16, 2016).
Laws of Minnesota. 2009. Chapter 58; codified as Minnesota Statutes, 253B.095, subdivision 1(d)
(4) and (e). https://www.revisor.mn.gov/statutes/?id=253B.095 (accessed October 26, 2016).
Mannix, A. 2011. Charles Schulz under scrutiny for Seroquel study suicide. City Pages
(Minneapolis), February 2. http://www.citypages.com/news/charles-schulz-under-scrutinyfor-seroquel-study-suicide-6747988 (accessed August 16, 2016).
Matson, S. 2005. FDA establishment inspection report, Stephen Olson MD. Report no. FEI
3004927371, July 22. https://www.scribd.com/doc/49641428/FDA-Inspection-Markingsonsuicide (accessed August 17, 2016).
McCook, A. 2016. Do interventions to reduce misconduct actually work? Maybe not, says
new report. Retraction Watch, April 16. http://retractionwatch.com/2016/04/12/dointerventions-to-reduce-misconduct-actually-work-maybe-not-says-new-report/ (accessed
August 16, 2016).
Michael, C. M., S. J. Nass, and G. S. Omenn, eds. 2012. Evolution of translational omics:
Lessons learned and the path forward. Washington, DC: National Academies Press
(U.S.).
Moore, J. 2009. U medical ethics group has industry ties. Star Tribune (Minneapolis),
December 4. http://www.startribune.com/u-medical-ethics-group-has-industry-ties
/78569782/ (accessed August 16, 2016).
Moore, J., and M. Lerner 2009. Once-secret drug-company records put U on the spot. Star
Tribune (Minneapolis), March 19. http://www.startribune.com/once-secret-drug-company
-records-put-u-on-the-spot/41470522/ (accessed August 16, 2016).
Moore, J., M. Lerner, and J. Marcotty. 2008. U doctor on ethics panel was disciplined. Star
Tribune (Minneapolis), December 28. http://www.startribune.com/december-21-u-doctoron-ethics-panel-was-disciplined/36500989/ (accessed August 16, 2016).

14

C. ELLIOTT

Mulcahy, T. 2010. A case for recalibrating risk tolerance: status report from the risk tolerance
working group, Board of Regents audit committee, June 10. http://www.research.umn.edu/
crad/documents/RiskTolerance.pdf (accessed August 17, 2016).
New York Times. 2007. U.S. deems Wyeth schizophrenia drug not approvable, August 7.
http://www.nytimes.com/2007/08/10/business/wyeth-reuters.html?_r=0
(accessed
August 16, 2016).
Office of the Legislative Auditor (OLA), State of Minnesota. 2015. A clinical drug study at the
University of Minnesota Department of Psychiatry: The Dan Markingson case, March 19.
http://www.auditor.leg.state.mn.us/sreview/markingson.pdf (accessed August).
Olson, J. 2009a. Minnesota house, senate unanimously pass limits on researchers use of
mentally ill patients. Pioneer Press (St. Paul), May 8. http://www.twincities.com/2009/05/
07/minnesota-house-senate-unanimously-pass-limits-on-researchers-use-of-mentally-illpatients/ (accessed August 17, 2016).
Olson, J. 2009b. U Doctor scrutinized over drug research. Pioneer Press (St. Paul), March 19.
http://www.twincities.com/2009/03/18/u-doctor-scrutinized-over-drug-research/ (accessed
August 16, 2016).
Olson, J. 2015. University of Minnesota proposes new safety, ethics oversight of research. Star
Tribune (Minneapolis), May 18. http://www.startribune.com/university-of-minnesotaproposes-new-safety-ethics-oversight-of-research/304121711/ (accessed August 16, 2016).
Olson, J. 2016. Review finds lapses at University of Minnesota psychiatry department. Star
Tribune (Minneapolis), February 11. http://www.startribune.com/assessment-findsproblems-with-research-consent-in-u-of-m-psychiatry-department/368496571/ (accessed
August 16, 2016).
Perry, S. 2015. U of M suspends enrollment in psychiatric drug Trials in the wake of scathing
report on Markingson case. MinnPost, March 20. https://www.minnpost.com/secondopinion/2015/03/u-m-suspends-enrollment-psychiatric-drug-trials-wake-scathing-reportmarkings (Accessed August 16, 2016).
Rigert, J., and M. Lerner. 1993a. University kept silent for four years on research misconduct
by Garfinkel. Star Tribune (Minneapolis), August 12. https://www.scribd.com/document/
114545057/Garfinkel-Case-at-the-University-of-Minnesota (accessed August 16, 2016).
Rigert, J., and M. Lerner. 1993b. Professor accused of coercing Hmong into U drug study.
Star Tribune (Minneapolis), October 10. https://www.scribd.com/doc/114822452/HalikasScandal-News-Reports (accessed August 16, 2016).
Sherman, L. A. 2000. Regulatory hearing on the proposal to disqualify James Anastasio Halikas
from receiving investigational new drugs. United States Food and Drug Administration.
http://www.circare.org/fdawls3/halikas_20000503.pdf (accessed August 17, 2016).
State of Minnesota Board of Social Work. 2012. Agreement for corrective action in the matter
of Jean M. Kenney, November 8. http://circare.org/dw/ACA_Kenney-13622-11082012.pdf
(]accessed August 17, 2016).
Thomas, K. 2015. A drug trials frayed promise. New York Times, April 17. http://www.
nytimes.com/2015/04/19/business/seroquel-xr-drug-trial-frayed-promise.html
(accessed
August 16, 2016).
Tosto, P. 2007. U medical deans Pepsi connection splits peers. Pioneer Press (Minneapolis),
March 5. http://www.twincities.com/2007/03/04/u-medical-deans-pepsi-connection-splitspeers/ (accessed August 16, 2016).
Tosto, P. 2008. Will study staff raise concerns? Pioneer Press (St. Paul), May 19. http://www.
twincities.com/2008/05/18/will-study-staff-raise-concerns/ (accessed August 16, 2016).
Tosto, P., and J. Olson 2008. Dan Markingson had delusions. Pioneer Press (St. Paul),
May 18. http://www.twincities.com/ci_9292549 (accessed August 17, 2016).

ACCOUNTABILITY IN RESEARCH

15

TPT Almanac. 2015. U of M human drug trials controversy, April 17. http://www.mnvideo
vault.org/mvvPlayer/customPlaylist2.php?id=27671&select_index=3&popup=yes (accessed
August 16, 2016).
U.S. Department of Justice. 1998. University of Minnesota pays 32 million to settle allegations
of selling an unlicensed drug and mishandling NIH grant funds. News release,
November 17. http://www.justice.gov/archive/opa/pr/1998/November/549civ.htm
(accessed August 16, 2016).
Webb, P. 2016. Office of research compliance, letter to Carl Elliott, January 27. https://www.
scribd.com/doc/297005044/Pamela-Webb-Research-Compliance-Office-Response-to-CarlElliott-Regarding-Robert-Huber-and-Bifeprunox-Study.
Yarborough, M., K. Fryer-Edwards, G. Geller, and R. R. Sharp. 2009. Transforming the
culture of biomedical research from compliance to trustworthiness: Insights from nonmedical sectors. Academic Medicine 84 (4):47277. doi:10.1097/ACM.0b013e31819a8aa6.

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