The FDA, Dr. Stephen Olson, & the University of Minnesota

In November 2014, the FDA inspected University of Minnesota psychiatrist and clinical investigator Dr. Stephen Olson. Dr. Olson was the site PI for the CAFÉ trial, the notorious study in which St. Paul resident Dan Markingson committed suicide. Olson is also the principal investigator for other studies that prompted complaints about how individuals suffering from mental illness are mistreated in psychiatric clinical trials conducted at the University of Minnesota.

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Despite a disturbing institutional record that has prompted a faculty senate resolution which resulted in a review of clinical research at the University, an ongoing investigation conducted by Minnesota’s Legislative Auditor, a petition calling for Governor Mark Dayton to launch an independent investigation of Markingson’s death, a letter over 170 academics signed in support of an investigation of possible research misconduct, internal reviews of several psychiatric clinical trials, and sharp criticism from former Minnesota Governor Arne Carlson, there has been no news media coverage of the FDA inspection. It is as though pleas for inquiries into research misconduct are now so familiar to local reporters that an FDA inspection of the researcher at the center of these controversies does not pique their curiosity.

Acknowledging the limited information in the public domain, perhaps we are nearing the collapse of the University’s longstanding façade that all is well with the conduct and institutional oversight of psychiatric clinical trials.

Photo: Dr. Stephen Olson

In early December, Dr. Ernest Prentice, a former expert witness in the lawsuit Mary Weiss filed against the University of Minnesota following her son’s death, gave a presentation at PRIM&R’s annual conference. Prentice’s talk was the subject of a highly critical report by Dr. Judy Stone. What has not been previously reported is what happened shortly after Prentice’s bungled defense of the University of Minnesota Institutional Review Board’s oversight of the CAFÉ trial. Prentice’s presentation was Saturday, December 6. The next morning, a jarring exchange reportedly took place at the workshop, “A Dialogue with the FDA.”

According to two individuals who attended that session, a woman in the audience asked FDA officials to address various conflicts-of-interest related to the Markingson case. In response, one of the panellists, Catherine Parker, of the FDA’s Center for Drug Evaluation and Research, reportedly turned to her FDA colleagues on the panel and said, “Can we say, ‘no comment’?” The other FDA employees did not respond. Parker is then reported to have said, “It is the FDA’s policy not to comment on open investigations. So ‘no comment.’”

In response, the questioner reportedly said: “So the FDA is investigating the Markingson case?”

Parker again replied, “no comment.”

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It is indeed FDA policy not to disclose details concerning ongoing investigations or acknowledge whether investigations are in progress. However, one way to interpret Parker’s remarks is that when faced with challenging questions about the FDA’s prior investigation of the Markingson case, she replied by revealing that an FDA investigation is in underway.

Asked to address questions concerning whether the FDA is investigating Dr. Olson and the Markingson case, university officials are as unforthcoming as always.   According to Dr. Brian Herman, the University’s Vice President for Research,

The FDA conducted a clinical investigator inspection involving Dr. Stephen Olson in November 2014. To the extent FDA investigators find deviations from statutes or regulations during an inspection, they issue a Form 483 (Inspectional Observations) at the conclusion of the inspection. The FDA investigators did not issue a Form 483 to Dr. Olson. To the University’s knowledge, the FDA has not yet issued its written inspection report.”

Review of the FDA’s website confirms that there is no public record of a “483”, an FDA establishment inspection report, or any regulatory action related to the FDA’s inspection of Dr. Olson. The purpose, scope, and outcome of the FDA inspection are therefore unclear. Catherine Parker’s remarks at the PRIM&R conference suggest that FDA officials there could not respond to questions about Dan Markingson because there is an ongoing FDA investigation connected to his death. Herman, in contrast, appears to suggest that the FDA inspection of Dr. Olson involves nothing more than routine monitoring of a clinical trial investigator.

The AAHRPP review of clinical research protections at the University was supposed to be submitted February 15. The Legislative Auditor’s report is reportedly going to be released next month. Now, it appears that the FDA is also examining Dr. Olson’s activity as a principal investigator.

For years senior university officials have used the badly flawed 2005 FDA establishment inspection report issued after Markingson’s death as a shield against calls for an independent investigation of psychiatric research misconduct. If an FDA investigation is in progress, is that tactic nearing its expiration date?

Given the many past and present senior university administrators, compliance officers, and PR spokespersons who have defended from criticism Dr. Olson, Department of Psychiatry Chair and CAFÉ study co-investigator Dr. Charles Schulz, former IRB Chair Dr. David Adson, and other psychiatrists, there must be a substantial number of individuals hoping that the FDA inspection was indeed “routine.” After years of university officials stonewalling critics and refusing to investigate repeated allegations of research misconduct, if the FDA does find violations related to the conduct of psychiatric clinical trials it is unlikely the agency will conclude that wrongdoing was limited to the clinical setting.


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