January 14, 2015

Brian Herman, PhD

Vice President for Research
University of Minnesota
101 Pleasant Street, Minneapolis, MN 55455
Dear Vice President Herman:
At a conference in December, FDA employees participating in an Ask the FDA panel session were
questioned about the death of Dan Markingson. FDA officials reportedly responded by stating that they could
not comment on the Markingson case due to an ongoing FDA investigation. In light of this public statement
by FDA officials, we wish to ask you four questions.
First, is the FDA investigating Dr. Stephen Olson for possible violations of federal regulations governing
human subjects research?
Second, if the FDA is investigating Dr. Olson, why is the University of Minnesota allowing him to continue
recruiting new research subjects rather than waiting until the investigations findings are publicly disclosed?
Third, university officials have repeatedly claimed that the FDA found no wrongdoing when an FDA
investigator completed an inspection report after Dan Markingsons suicide in the CAF study. Given
administrators assertions that no additional investigations of possible research misconduct are required
because the FDA has already investigated, if an FDA investigation of Dr. Olson is in progress why have you
not issued a public statement acknowledging that the FDA is re-examining Markingsons death?
Fourth, if the FDA is investigating Dr. Olson, have you brought this development to the attention of Minnesota
Legislative Auditor James Nobles, the Minnesota Board of Medical Practice, and AAHRPP?
Yours sincerely,

Leigh Turner, PhD

Associate Professor, University of Minnesota Center for Bioethics

Carl Elliott, MD, PhD

Professor, University of Minnesota Center for Bioethics