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Center for Bioethics N504 Boynton

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


Dr. Susan Berry
Chair, IRB Executive Committee
University of Minnesota
D528 Mayo Memorial Building
420 Delaware St. SE
Minneapolis, MN 55455-0392

J anuary 2, 2014

Dear Sue:

I am writing to you in your capacity as Chair of the Executive Committee of the IRB.

On November 17, KMSP-TV aired an investigative report about the death of Dan Markingson in
the AstraZeneca-sponsored CAFÉ study, which was conducted under the supervision of Dr.
Stephen Olson in the Department of Psychiatry. Although the Markingson case has received a lot
of attention, the KMSP report also revealed several alarming issues surrounding a second
(anonymous) psychiatric patient who appears to have been harmed in a research study conducted
by Dr. Olson.

According to the report, Dr. Olson recruited this patient into an industry-sponsored antipsychotic
study after the patient presented at the Fairview emergency room visit with symptoms of serious
mental illness. The subject told the KMSP reporter, J eff Baillon, that he does not believe that he
was mentally competent to give proper informed consent. He agreed to take part in the study
only because he was afraid that otherwise he would not be allowed to leave the hospital. He told
Baillon,"You know, when you're locked up in a place, you're very scared and you're willing to do
whatever anyone basically suggests."
Once in the study, the subject was given an unapproved antipsychotic drug. According to the
KMSP report, the subject experienced side-effects so severe that he considered suicide. Dr.
Olson was allegedly unresponsive to his complaints, and the subject eventually dropped out of
the study. The study drug itself was never approved by the FDA.
Although the details in the KMSP report are limited, I believe they are disturbing enough to
warrant further investigation. The similarities between this case and that of Dan Markingson are
striking: a research subject of questionable competence, an industry-funded study of an
antipsychotic drug, and serious adverse events that appear to have gone unaddressed by the
investigator. In addition, both studies were conducted by the same psychiatrist, Stephen Olson.
I hope that the KMSP report has already led the IRB to look into potential ethical violations in
the care of the research subject in question. But if not, I would like to ask that you consider
doing so now. As you may know, in the past I have asked many different offices and individuals
at the university to look into ethical issues surrounding clinical trials in our Department of
Psychiatry, including the Research Integrity Officer, the CTSI Research Consultation Service,
the CTSI Research Subject Advocate, and the Board of Regents. All have refused, which is why
I am going to you with this request.
Here is a link to the KMSP television report:
http://www.myfoxtwincities.com/story/23994239/investigators-side-effects-of-drug-study
I would be glad to talk to your further about this in person. Thanks for your consideration.
Yours sincerely,


Carl Elliott
Professor, Center for Bioethics