Anda di halaman 1dari 3

Center for Bioethics

N504 Boynton
410 Church Street
Minneapolis MN 55455
612-624-9440
Fax: 612-624-9108
www.bioethics.umn.edu

Ms. Adrienne Baranauskas


Director, Research Administration
University of Minnesota Medical Center, Fairview
2450 Riverside Ave.
Minneapolis, MN 55454
January 29 2014
Dear Ms. Baranauskas:
I am writing to file a complaint about IRB oversight of at least two clinical trials conducted in
the University of Minnesotas Department of Psychiatry, one of which was federally funded, and
possibly oversight of other trials. IRB oversight of those trials violated 45 CFR 46.107(e) which
states, No IRB may have a member participate in the IRB's initial or continuing review of any
project in which the member has a conflicting interest, except to provide information requested
by the IRB.
The first trial in question is NCT00034892 Comparison of Atypicals in First Episode
Psychosis (CAF), sponsored by AstraZeneca. The Principal Investigator for the University of
Minnesota site was Dr. Stephen Olson in the Department of Psychiatry. The Co-Investigator was
Dr. Charles Schulz, Chair of the Department of Psychiatry. The CAF study ran from March
2002 through March 2005.
The second trial is NCT00014001 Clinical Antipsychotic Trials of Intervention Effectiveness
(CATIE), sponsored by the National Institutes of Mental Health. The Principal Investigator at
the University of Minnesota for this study was also Dr. Stephen Olson. The CATIE study ran
from December 2000 through December 2004.
There is evidence of misconduct at the University of Minnesota in both of these studies. Dan
Markingson, a psychotic young man under an involuntary commitment order, was recruited into
the CAF study over the objections of his mother and eventually committed a violent suicide,
nearly decapitating himself. That suicide has been the subject of heated controversy for years.
Last year, the study coordinator for both the CAF and the CATIE studies, Jean Kenney, was the

subject of a corrective action by the Minnesota Board of Social Work. The Board found that
Kenney had falsified the initials of physicians on study charts, dispensed study drugs without a
license, performed tasks beyond her competency (such as evaluating drug side-effects), failed to
heed warnings of an impending suicide, and "consistently fell below the minimum standards of
practice for a clinical social worker."
Recently, after filing a Minnesota Data Practices Act request, I obtained a redacted copy of the
minutes for the May 26, 2004 and June 23, 2004 IRB meetings. Those meetings included the
first continuing reviews of the CAF study after the suicide of Dan Markingson. The minutes
show that the Chair of the IRB at the time was Dr. David Adson, whose conflicts of interest
should have precluded him from taking part in any meetings in which this study was discussed.
In fact, according to his CV, Dr. Adson chaired the IRB panel from 1998 through 2005, which
suggests that he not only did he participate in the approval and continuing review of the CAF
study, but of the CATIE study as well.
The minutes do not suggest that Adson was recused from the CAF study review. No conflict of
interest was declared for either meeting. But if the information I have been able to obtain is
correct, Dr. Adson had several significant conflicts of interest that should have precluded his
review of these studies.
First, according to his CV, from 2002 until at least 2009, Dr. Adson was Director of the
Ambulatory Research Center, the unit where many psychiatric studies at the university
including the CAF and CATIE studies -- are housed and administered. Dr. Adson should not
have been responsible for approving studies in his own unit.
Second, as an assistant professor in the Department of Psychiatry, Dr. Adson was a colleague of
Dr. Olson, the Principal Investigator for both studies. Administratively, Dr. Adson answered to
Dr. Charles Schulz, the Co-Investigator on the CAF study. These relationships also constitute a
conflict of interest.
Third, in 2004, the year when the IRB received notice of Markingsons suicide, Minnesota Board
of Pharmacy records indicate that Adson received $5,200 as compensation for services to
AstraZeneca, which sponsored the CAF study, and whose drug, Seroquel (quetiapine) was
being evaluated in the CATIE study. In 2005, when Dr. Adson was still IRB chair, he received
$16,884 from AstraZeneca. In total, according to Board of Pharmacy records, AstraZeneca paid
Dr. Adson over $149,000.
Later, Dr. Adson received substantial funding from other manufacturers of psychiatric drugs with
trials at the University of Minnesota, including Forest, which produces Lexapro (escitalopram)
and Bristol Myers-Squibb, which produces Abilify (aripiprazole.) In total, from 2002 to 2010,
Dr. Adson received at least $650,000 in consulting, research, and speaking fees from the
pharmaceutical industry. (I have attached the records I have found in the Board of Pharmacy

database, which can be found at http://extra.twincities.com/CAR/doctors/default.asp. Because of


reporting inconsistencies, some payments appear more than once.)
I should also note that, according his CV, Dr. Adson served on the Academic Health Center
Conflict Review and Management committee from 1998 until 2008. This is the university body
charged with monitoring and managing financial conflicts of interest.
I should point out that scope of this complaint not only includes concerns about oversight of the
CATIE and CAF studies, but potentially a wide range of studies overseen by the IRB. It is
possible that there were other Serious Adverse Events, including suicides, in these studies.
However, I have so far been unable to obtain the relevant documents from the University of
Minnesota, despite repeated Data Practices Act requests. It is my hope that you will have more
success obtaining those documents.
I am attaching copies of the March 24, 2004 IRB meeting (redacted), the relevant Board of
Pharmacy records, the Corrective Action for Jean Kenney, and a copy of Dr. Adsons CV, which
is available on the website of the MAPS Applied Clinical Research Center in Minnesota.
Please let me know if I can provide any further information.

Yours sincerely,

Carl Elliott MD PhD


Professor, Center for Bioethics