U of M releases reviews of psychiatric research
The University of Minnesota released several reports Friday relating to ongoing questions and concerns about drug research conducted by the Department of Psychiatry. The Fox 9 Investigators had requested access to the reports months ago. They were finally made public on Friday after Dr. Stephen Olson, the subject of an FDA inquiry as well as an internal U of M investigation, agreed to authorize their release.
In March, the Minnesota Legislative Auditor harshly criticized the school's drug research program in a report to lawmakers. The auditor's office found that school leaders consistently ignored conflicts of interest and other ethical issues. A few weeks earlier, a national panel of experts issued an independent review of the program that said the school needed to do more to protect people enrolled in the drug studies.
The reports come after the 2004 death of Dan Markingson, who committed suicide while enrolled in a drug research study in the Department of Psychiatry. The 26-year old man suffered from schizophrenia and died after he tried to decapitate himself. Since the two reports came out, U of M officials have suspended enrollment in all Department of Psychiatry interventional drug studies and say they have taken other recommended steps to improve the drug research program.
In a press release about the reports released on Friday the U of M wrote: "…while there are areas for improvement, patient safety has not been compromised."
Below are links to the reports released by the University of Minnesota:
FDA Report: http://www.health.umn.edu/sites/default/files/FDA-EI-Report-May-15.pdf
Report from the IRB: http://www.health.umn.edu/sites/default/files/IRB-Investigation-Report-Release.pdf
Report from FTI: http://www.health.umn.edu/sites/default/files/FTI-Release.pdf