An Open Letter

Dear Legislator:

February 2015

In so many ways, colleges and universities are the pacesetters for civilization. It is not just a matter
of education or technological advancement but, of greater importance, they represent our search
for the highest levels of truth and integrity. That may sound abstract but it is a fundamental
expectation.
To Minnesotans, the University of Minnesota symbolizes our best efforts in education, research,
and public service. We care deeply about the Maroon and Gold because we know it represents
our advancement.
But the University is also a complex organization requiring a diverse array of skill sets in order to
provide the proper guidance, leadership, and management. The following is a summary review of
the University’s clinical drug research trials. Sadly, it concludes that the high level of competence
and integrity required has been absent.
Any endeavor that involves corporate contracts for research requires special scrutiny due to the
obvious conflicts of interest and temptations involved. In this case, drug companies have been
paying for the testing of experimental drugs and researchers have been financially rewarded for
enrolling participants and administering drugs according to accepted medical protocols. As the
attached report notes, serious questions have arisen relative to the poor study design and biased
results, numerous conflicts of interests, six suicides, multiple injuries, the FDA banning of some
researchers, the felony conviction and imprisonment of a professor, and an unhealthy research
environment.
Most disturbing is the deliberate refusal of the Board of Regents to publicly review or hold
hearings on what they knew was clearly a troubled area. Time and again, they have perpetuated
the falsehood of numerous and extensive investigations, including one investigation supposedly
conducted by the University long after its own Vice-President for Regulatory Affairs testified
under oath in a 2006 lawsuit that the University did not conduct any such investigation. Their
actions were deliberate and every Regent should have known that their claims were untrue. To
make matters worse, it was this sham of extensive investigations that was utilized by the
administration to fend off calls for an independent inquiry. At times, the administration’s rebuttals
were quite strong and included referring to a clinical investigator calling for an independent
investigation into the Markingson case as a “wacko”.
Further, there is no indication that the Board of Regents, as the body responsible for hiring
management and providing oversight of the University on behalf of the taxpayer via the
Legislature, ever inquired about a report from this investigation, or ever called anyone raising red
flags, including two of their own professors from the Center of Bioethics, Dr. Carl Elliott and Dr.
Leigh Turner. Nor did the Board seem interested in the conflicts of interest involved with testing
drugs in company-sponsored clinical trials.
Of further concern is the role of the internal and external compliance audit function. How could
so many audits miss so much? With all of the negative media attention, it is hard to understand
the lack of curiosity of a professional function that prides itself on being thorough and inquisitive.

And then we have a management system that seemed to find everything from human tragedy to
an array of conflicts of interest as quite normal and acceptable.
This leaves the most serious question. Where do we go from here? The state constitution makes it
clear that the buck stops with the Legislature since it appoints the Board of Regents and is
expected to evaluate their performance. Sadly, the evaluation piece seems to have been absent in
recent years. That is a huge omission because it further weakens an already malfunctioning
oversight system.
Requesting the involvement of the Legislative Auditor is a solid first step. That office’s strength
has been its ability to evaluate management, thoroughly review the data and make positive
recommendations for improvement. Their report will be most welcome.
In addition, there are two other recommendations that warrant serious consideration by the
Legislature:
1 – Annual committee reviews in the House and Senate of the performance of the Board of
Regents. This would not be part of the appropriation process but rather an open hearing relative
to goals and objectives, performance, challenges, etc. After all, the Legislature by law has the
ultimate responsibility and they are the peoples’ representatives.
2 – The appointment of a special citizen’s commission to review psychiatric drug research and the
entire oversight process including Board and management performance. This panel should
consist of distinguished and capable Minnesotans reflecting a variety of skill sets but deeply
committed to the highest standards of integrity and competency. Additionally, this group can
assist the Legislature in setting up a more professional process for the selection of Regents.
Defined and proven leadership talents must replace the current system which is little more than a
political beauty contest. A good Board can only come about if legislators actually seek out the
talent they need.
This combination of endeavors holds out the promise of restoring trust, transparency, and a high
level of competence to a program sorely in need of a major overhaul.
Respectfully submitted,
Arne H. Carlson, Former Governor of Minnesota
Carl Elliott, M.D., Ph.D., Professor of Bioethics, University of Minnesota
Leigh Turner, Ph.D. Associate Professor of Bioethics, University of Minnesota
Mike Howard, Retired businessman & friend of Mary Weiss

 

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Summary – Drug Testing
University of Minnesota
February 2015
The University of Minnesota, like many other research institutions, tests
experimental drugs. The understanding between the companies that develop these drugs
and the consuming public is that the drugs have been thoroughly tested on humans and
that these tests meet the highest standards. This assures the Food and Drug
Administration serving as the protector of public safety that they will only certify for
public usage those drugs that are deemed safe and meet the established standards.
However, in recent years studies have been showing that drug tests performed by
universities and funded by drug companies have a clear bias towards positive results.
According to a May 2008 article in the St. Paul Pioneer Press, “A growing body of research
suggests that drug company money has an influence on study outcomes. One analysis
found that industry-funded research was four to five times more likely to produce positive
outcomes for a paying company’s drug than federally funded research. “ Considering the
hundreds of millions of dollars that flow from drug companies to research universities, this
finding is not surprising.
It would appear that the most prudent approach to this new evidence would be
for the federal government and research universities to come together and work toward a
common solution. It is intolerable to have a situation where the public’s health and
wellbeing may be placed in jeopardy due to tainted research. One simple approach would
be for the drug company money to flow to the National Institutes of Health (NIH) and for
that body to assume responsibility for awarding research grants and providing the
oversight of protocols. This would place research integrity over the powerful influence of
money.
Unfortunately, that has not happened across the board nor at the University of
Minnesota. Neither the Board of Regents nor the management at Morrill Hall has been
moved to review this issue.
That relaxation of standards of excellence and the repeated unwillingness to
examine the problems with drug testing sends a message to the rest of the system. That is
welcome news to those who are willing to pursue personal gain over the integrity of
research. To bring that message closer to home, consider the case of Dr. Faruk
Abuzzahab, a former Professor of Psychiatry at the University of Minnesota. According
to the Boston Globe (November 17, 1998), Susan Endersebe was a patient at Fairview
Riverside Hospital receiving treatment for “schizophrenia and suicidal impulse”. By all
reports, she was faring well and looking forward to leaving. But, according to the
newspaper, “she was referred to psychiatrist Faruk Abuzzahab, an encounter that put her
on a path that led to her death.”

 

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Abuzzahab, who had a contract with Abbott Laboratories, enrolled Endersebe into his
drug trial. Following her suicide, he acknowledged to state investigators that he had
violated some key protocols including ignoring “study criteria that excluded patients who
were suicidal.” Further, he took her off the antipsychotic medication that was working
and put her on the experimental drug. Within three days she committed suicide.
Dr. Morris Goldman, Associate Professor of Psychiatry at the University of
Chicago School of Medicine, who was called in by the Minnesota Board of Medical
Practice to investigate Abuzzahab’s transgressions, declared, “The abuses are there. A big
part is the dollars involved.”
He continued, “People are drawn into this field because they are interested in
dollars. They are very profit-conscious. And that combination of a lot of money, plus the
added ethical dilemma you face in human research, that is a bad combination.”
Ultimately, Dr. Abuzzahab was charged by the Minnesota Board of Medical
Practice with a “reckless, if not willful, disregard” for the welfare of “46 patients, five of
whom died in his care or shortly afterward.”
His license was suspended for seven months and he was placed under closer
supervision. In a twist of irony, Abuzzahab was directed to attend an ethics class taught
by Professor Carl Elliott, who would later become the most outspoken critic of how the
University tests drugs.
Bear in mind that this case came after an equally notorious case. In 1989,
Dr. Barry Garfinkel, Director of the University’s Child and Adolescent Psychiatry
Department, was investigated by a University panel and found to be “fabricating records”
and involved in a variety of other violations. However, according to the Star Tribune the
university “kept silent for four years” about his research misconduct.
Ultimately, Garfinkel was found guilty of “five counts of mail fraud and filing false
statements in connection with his research on Anafranil, an anti-depressant drug.” He
was sentenced to federal prison and fined, and in 1998 he was disqualified by the FDA
from conducting research.
As a result of another investigation, Dr. James Halikas, director of the Chemical
Dependency Unit in the Department of Psychiatry, was disqualified by the FDA from
conducting research on humans in 2000. Halikas had recruited illiterate Hmong opium
addicts into a study of gamma hydroxybutyrate, or GHB, for opiate addiction. GHB is a
central nervous system depressant linked to seizures and coma that is sometimes used as a
date rape drug. Despite the fact that Halikas was a member of the University of
Minnesota IRB, he never obtained informed consent from his subjects, and it is unclear
whether subjects were even aware that they were in a research study. According to the
FDA investigation, several of the subjects were severely depressed and at risk of suicide,
and should have never been enrolled in the study even if they had given informed
consent.
 

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Perhaps the case that created the most public attention was that of Dan
Markingson, 26, who committed a violent suicide in May 2004. Tragically, the Dakota
County District Court had placed him under a civil commitment order that required him
to obey the recommendations of his psychiatrist, Dr. Stephen Olson, Director of the
University of Minnesota schizophrenia program as well as a paid researcher and speaker
for AstraZeneca, a pharmaceutical company. Markingson was enrolled in an
AstraZeneca antipsychotic trial called the CAFÉ study in spite of serious concerns over
his competency or decision-making capacity. Each research subject who served through
completion for the CAFÉ study brought in over $15,000 from AstraZeneca -- hence, the
pressure to recruit and retain subjects.
Mary Weiss, Markingson’s mother, noted a major deterioration in her son’s
condition and attempted to have him removed from the CAFÉ study. Her warnings were
ignored. In mid-April, she left a message with the study coordinator: “Do we have to wait
until he kills himself or someone else before anyone does anything?”
Nobody did anything. Three weeks later his mutilated body was found.
From this point on, the University’s role becomes both confusing and disturbing.
The University’s Institutional Review Board panel (IRB) chaired by Dr. David
Adson presumably examined the case. However, Adson failed to disclose his close
financial ties to the company whose drug was involved in the Markingson case and his
overall ties to the industry valued in excess of $585,000. In addition, the University
maintained that exhaustive reviews were conducted by the Hennepin County District
Court, the Minnesota Board of Medical Practices, and the office of the Attorney General.
Yet letters from the Board and the Attorney General’s office indicate otherwise.
It is equally curious that Richard Bianco, the University’s Vice-President for
Regulatory Affairs, categorically denied the University’s contention of “exhaustive
studies” under oath in a legal proceeding:
Question: Has the University done any investigation into the death of Dan Markingson?
Answer: No.
Question: To the best of your knowledge, did anyone at the IRB, at the University of
Minnesota, or anyone under your office investigate this case, actually look at the records and see
the court documents that I’m describing, and if so, could you give me the name of that person?
Answer: Not to my knowledge.
Question: Nobody did that?
Answer: No.
In spite of this obvious conflict within the University over an issue of accuracy and
truthfulness, there has not been an inquiry from the Board of Regents nor the Office of
the President. This institutional indifference is further reflected in its unwillingness to deal
either with any of the conflicts of interests cited nor with the more serious concerns over
 
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the safety and protection of the enrollees in these drug testing trials. So far to date, there
have been at least six deaths and many more serious injuries, and yet not a single public
meeting on the subject held by the Board of Regents. Further it should be noted that the
University has been unable to provide the actual number of deaths and injuries that have
occurred in psychiatric research studies which raises another series of concerns about
management.
In addition to the above episodes, the following has also occurred:
§

Dr. Leo Furcht was appointed by the former Dean of Medicine to serve as
chairman of the Medical School’s Committee on Conflicts of Interest. His prior
history includes “secretly steering a $501,000 research grant to his own company”
(Star Tribune – December 28, 2008). He was reprimanded for a “serious violation”
of University policy relative to conflicts of interest and ordered to return the
money.
Yet, somehow he was deemed fit to lead an ethics reform effort. That would
appear to be comparable to appointing Bernie Madoff head of the SEC on the
grounds of experience.

§

Brian Lucas, whose mother serves on the Board of Regents, is the Senior Director
of Communication for the Academic Health Center. In this capacity, he has been
described as being extraordinarily difficult to deal with and an obstructionist when
it comes to obtaining records, etc.

§

In September 2014, three national experts commissioned by President Kaler
arrived on the campus of the University to review procedures involving the care of
patients in research studies. In spite of all the problems noted with blatant conflicts
of interests, this panel has a member who “was a consultant to the company that
ran the drug study in the Markingson case” (Star Tribune, September 18, 2014).
How curious that in a nation with over 890,000 physicians, Morrill Hall has not
been able to put together a review panel without tripping over a gigantic conflict
of interest.

§

On November 26, 2012, Jean M. Kenney, the study coordinator for the clinical
trial in which Dan Markingson died, signed off on a “corrective action” by the
Minnesota Board of Social Work. The action stated that Kenney had gone
beyond her competence as a social worker and involved herself in making
decisions that required medical training. She was cited for “numerous
documentation errors” including “incorrectly listing client #1’s diagnosis as
hyperthyroidism rather than hypothyroidism.” Later she mistook the dosage
involved in client #1’s treatment listing the dosage as 25 mg (milligrams) instead
of 25 mcg (micrograms).
She further “dispensed legend prescription drugs without authorization” and
“routinely initiated clinical documents with a physician’s initials when the

 

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physician neglected to do so.” There were numerous other violations noted in the
“Agreement for Corrective Action.”
It should be further noted that client #1 was revealed to be Dan Markingson and
that Mrs. Kenney’s legal bills were paid for by the University.
§

Channel 9 TV reporter, Jeff Baillon, has done a well-researched series of stories
worthy of national recogniztion on the conflicts of interest, the stonewalling and
the countless failures to properly and humanely protect enrollees. One key figure
is Niki Gjere, a psychiatric clinical nurse specialist at Fairview Hospital where
Dan Markingson was a research subject under the supervision of Dr. Olson.
Gjere’s comments were featured in a Channel 9 TV (November 25, 2014) report
entitled “Nurse Questions Integrity of U of M Drug Researchers.” She directly
contradicted the two lead psychiatrists, Dr. Stephen Olson and Dr. Charles
Schulz. The nurse maintained that she and others expressed concerns over
Markingson’s mental capacity as it related to his participation with clinical
research. She further raised concerns over the use of coercion and aggressive
recruiting tactics.
Central to her comments was the role of money. “It was as though research was
taking precedent over having them (research subjects) get better and having them
receive the care they needed to improve their symptoms, to improve their quality
of life.”
Later in the interview, she went on to describe a “culture of fear” that is intended
to keep hospital employees in line. Most incriminating was her revelation that she
made recordings of many of her key conversations and safely stored them. That
has caused some of the psychiatrists to “clarify” their previous comments.
Relative to the possibility of job loss, Gjere declared, “You don’t speak against the
University and not pay somehow.”
A few days later, she received a call that reinforced her fears. It was from Brian
Lucas, Director of Communications for the Academic Health Center and son of
Regent Peggy Lucas. Gjere described the conversation as “intimidating” and said
it nearly drove her to tears.
It is challenging to review all these events and not conclude that it goes beyond
institutional indifference to something more deliberate and sinister. How could
any system of management oversight brush aside six suicide deaths, an untold
number of injuries, a host of serious conflicts of interest, and a barrage of negative
publicity?
In a meeting with President Kaler and the Board of Regents Chairman, Richard
Beeson, Governor Carlson reviewed all of the violations and publicity and
repeatedly asked why the Board had steadfastly refused any public hearings.

 

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Beeson’s response was that it “has not risen to the level of our concern.” When
pressed on the negative publicity, he could only offer that “it has not hurt our
brand.”
In reviewing all the materials, it is hard not to conclude that what may have
started as indifference has likely become institutional stonewalling. There are so
many elements that point in that direction:





A uniform and centrally controlled message
A lack of transparency
Rewards for loyalists
Punishment for dissenters
Intimidation of whistleblowers
Threatened use of institutional power to coerce obedience

As has been mentioned, the Board of Regents and administrators have been declaring
time and again that there has been an endless array of investigations and no fault was
found. Typical has been the response of the University’s lead attorney at the time, Mark
Rotenberg.
“As we’ve stated previously, the Markingson case has been exhaustively reviewed by
Federal, State and academic bodies since 2004. The FDA, the Hennepin County District
Court, the Minnesota Board of Medical Practice, the Minnesota Attorney General’s
Office and the University’s Institutional Review Board have all reviewed the case. None
found fault with the University. None found fault with any of our faculty.”
Yet in the more than ten years that have lapsed since the death of Dan Markingson only
one report from an investigation has surfaced, and that is from the FDA. That report has
been criticized for its lack of scope. Nevertheless, it is the only written report that has
been made available. Where are all the rest? These are all public entities and the public
and the Legislature should be entitled to see these reports of the Markingson case that has
been so “exhaustively reviewed” by the court, the University, the Attorney General and a
state agency.
The time for full transparency and truthful inquiry has arrived.
Respectfully submitted,

Arne H. Carlson, Former Governor of Minnesota
Carl Elliott, M.D., Ph.D., Professor of Bioethics, University of Minnesota
Leigh Turner, Ph.D., Associate Professor of Bioethics, University of Minnesota
Mike Howard, Retired businessman & friend of Mary Weiss

 

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Drug Testing at University of Minnesota Has Drawn Media Attention
Star Tribune – August 1993
University Kept Silent for 4 Years on Research Misconduct by Garfinkel
Star Tribune – August 1993
Hasselmo Says He Didn’t Know of Fraud
Star Tribune – October 1993
Professor Accused of Coercing Hmong into ‘U’ Drug Study
Star Tribune – April 1994
Psychiatrist Sentenced for Research Fraud
Star Tribune – January 1995
‘U’ Psychiatrist Convicted of Fraud – Quits ‘U’ Opens Private Practice
Star Tribune – May 1998
‘U’ Psychiatrist is Fined for Improperly Conducting Drug Trials
Boston Globe – November 1998
Lure of Riches Fuels Testing
New York Times – June 2007
After Sanctions, Doctors Cost Drug Company Money
Pioneer Press – August 2007
Drug Makers Step Up Giving to Minnesota Psychiatrists
New Yorker – January 2008
Critical Review of Misuse of Volunteers in Drug Testing Program
St. Paul Pioneer Press – May 2008
Critical Three-Part Series on Drug Testing Program and its Abundant Conflicts
Interests.
Star Tribune - December 2008
U of M Doctor on Ethics Panel Was Disciplined
Internet Article – February 2011
Is U of M Department of Psychiatry Chair in Pocket of Astra Zeneca?
Star Tribune – July 2011
Did System Fail a Budding Killer?
 

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Star Tribune – November 2012
Sanctions Imposed in 2004 ‘U’ Drug Trial Death
MinnPost – March 2013
Why the University of Minnesota Psychiatric Research Scandal must be
Investigated
Internet – 2013
Pay No Attention to the Bloody Corpse in the Bathroom
Star Tribune – December 2013
Will the ‘U’ Review or Whitewash a Research Subject’s Death
MinnPost – March 2104
The U of M Should Thoroughly Investigate Issues in the Markingson Case
Science Magazine – May 2014
A Historical Analysis of the Markingson Case and Issues that Continue.
Star Tribune – June 2014
A Necessary Audit of University of Minnesota Drug Research
Star Tribune – September 2014
Faculty Members Challenge Panel Reviewing U’s Human Research
Star Tribune – August 2014
Doctors’ Industry Ties to Be Public
Star Tribune – September 2014
Review of U’s Human Research Draws Fire
Star Tribune - December 2014
For years, U Bioethicist has tested limits of Academic Freedom

 

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