In 2004, Dan Markingson brutally stabbed himself to death while participating in an experimental anti-psychotic drug study funded by AstraZeneca, called the CAFE study. According to several bioethics faculty members at the college, the road to the young man's death was pocked by serious ethical lapses, including conflict-of-interest relationships between U of M researchers and Big Pharma.
The college has repeatedly denied any wrongdoing, pointing to a number of state and federal entities that have investigated the case and cleared those who worked on the study.
The Board of Social Work explicitly cites the corrective action is not a disciplinary measure, and if Kenney completes 18 hours of continuing education, three hours of consultation, and drafts a report on what she learned, it will close its investigation. But the action against Kenney is significant because it's the first official body to find substantive errors on part of anyone who worked on the study.According to the board's findings, Kenney performed tasks beyond her competency, incorrectly documented a diagnosis -- "hyperthyroidism" instead of "hypothyroidism" -- and mislabeled Markingson's dosage in a log during the study. She routinely signed documents with physicians' initials, failed to address concerns raised by Markingson's family, and "consistently fell below the minimum standards of practice for a clinical social worker."
At one point during the study, sponsors warned of a newly discovered risk of hyperglycemia and diabetes. When Kenney didn't communicate this to Markingson, she invalidated his consent to join the study, according to the board.
Read the document in full here.
Despite the findings, the U of M still isn't budging. A statement from General Counsel Mark Rotenberg:
"Jean Kenney is no longer an employee at the University of Minnesota and hasn't been for a number of years. The University was not a party in the Corrective Action - that is a voluntary agreement between Ms. Kenney and the Minnesota Board of Social Work. We note that the Board-Kenney agreement provides for no discipline of Ms. Kenney.
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. Most importantly, none found any causal link between the CAFE trial and the death of Mr. Markingson."
Dr. Charles Schulz, chair of the school's psychiatry department and co-investigator on the CAFE study, has also since started work on a similar trial. Launching in 2008, the multi-site study examines the use of Seroquel XR to treat borderline personality disorder.
For those who have been critical of the college's handling of the Markingson case, it seems this week's development has pricked the wound. Carl Elliot, a U of M bioethicist who has loudly pushed for further investigation, wrote a blog post yesterday calling the board's sanction "hardly adequate to the offense," and questioning Kenney's work on other studies during her time at the U of M.
"This action raises very serious questions about data integrity and human subjects protection in other studies in which Kenney was involved, but were not investigated by the Board," says Elliot in an email to City Pages. "For example, Kenney was study coordinator for the CATIE study, which was federally funded. Is the university going to look into these other studies?"
Note: This story has been changed from publication to reflect a correction. In its original form, it said U of M psychiatry chair Dr. Charles Schulz had just been given the green light to start a new study on the effects of Seroquel XR. The study began in 2008.