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Letter from Carl Elliott to Susan Berry, Executive Chair of the IRB at the University of Minnesota, asking for a review of an incident of apparent research misconduct from November KMSP report.
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Letter From Carl Elliott to Susan Berry asking IRB to investigate incident from KMSP Report Jan 2 2104
Letter from Carl Elliott to Susan Berry, Executive Chair of the IRB at the University of Minnesota, asking for a review of an incident of apparent research misconduct from November KMSP report.
Letter from Carl Elliott to Susan Berry, Executive Chair of the IRB at the University of Minnesota, asking for a review of an incident of apparent research misconduct from November KMSP report.
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 CAF 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,