The Minnesota Board of Medical Practice’s Compromised Investigation of Dr. Stephen Olson

March 30, 2015

Mark A. Eggen, M.D.

President

Minnesota Board of Medical Practice

2829 University Avenue SE, Suite 500

Minneapolis, MN 55414-3246

 

Ruth Martinez, M.A.

Executive Director

Minnesota Board of Medical Practice

2829 University Avenue SE, Suite 500

Minneapolis, MN 55414-3246

Open Letter Concerning the Minnesota Board of Medical Practice’s Compromised Investigation of Dr. Stephen Olson

Dear Dr. Eggen and Ms. Martinez:

On March 19, 2015, the Office of the Legislative Auditor released its report, “A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case.” The report provides a devastating indictment of the Minnesota Board of Medical Practice’s investigation of the complaint Mary Weiss filed against Dr. Stephen Olson. Ms. Weiss’ son, Dan Markingson, committed suicide while he was a research subject in a clinical trial for which Dr. Olson was the principal investigator. Dr. Olson was also Mr. Markingson’s treating psychiatrist. The report states (p.24), “The Minnesota Board of Medical Practice’s review of Dr. Stephen Olson was compromised because the expert consultant the Board hired to analyze the case had numerous conflicts of interest.” The report dismisses the Board’s review (p.26) as “compromised and suspect.” While the report does not provide a detailed account of the consultant’s findings, it notes (p.13) that he “recommended that the Board dismiss the allegations against Dr. Olson.”

Without identifying him by name, the Legislative Auditor’s report provides detailed information concerning the consultant and the multiple conflicts-of-interest that should have precluded his involvement in the investigation of Dr. Olson. The report states (p. 25-26) that the consultant was Director of the Ambulatory Research Center, Vice-Chair of the University of Minnesota Department of Psychiatry Research Committee, a member of the Department of Psychiatry Research Council, Chair of the University of Minnesota IRB that met May 26, 2004 and reviewed paperwork submitted after Dan Markingson’s suicide, and a recipient of over $83,000 in payments from AstraZeneca in 2006. It is obvious from these details that the consultant hired by the Board of Medical Practice to conduct this investigation was Dr. David Adson, Dr. Olson’s colleague in the University of Minnesota Department of Psychiatry.

I am attaching a copy of Dr. David Adson’s curriculum vitae, minutes from the May 26, 2004 IRB meeting, and documentation of AstraZeneca’s payments to him. These documents are publicly available on the Internet. According to Dr. Adson’s CV, he was the Director of the Ambulatory Research Center where the CAFÉ study was housed, Vice Chair of the Department of Psychiatry Research Committee, and a member of the Department of Psychiatry Research Council. Meeting minutes reveal that Dr. Adson chaired the IRB that met May 26, 2004 and conducted a cursory review of Dan Markingson’s death. Additional records confirm that in 2006 Dr. Adson received over $83,000 in payments from AstraZeneca. It is clear that Dr. Adson was the highly conflicted reviewer hired by the Minnesota Board of Medical Practice and inaccurately characterized by the Board as an “independent expert consultant.” Astonishingly, according to the report (p.25), Dr. Adson alerted the Board to his many conflicts-of-interest “before it hired him to review the Markingson case.” Dr. Adson conducted the review despite knowing he had significant conflicts of interest that should have barred him as a reviewer. The Board of Medical Practice paid Dr. Adson to serve as a consultant even though he never should have been permitted to investigate his co-worker.

I want to review Dr. Adson’s many conflicts-of-interest before describing the steps that the Board must now take to rectify the grave injustice it has done Mary Weiss.

1) Before the Board of Medical Practice hired him as a consultant to the investigation of Dr. Olson, Dr. Adson received significant payments from AstraZeneca, the sponsor of the CAFÉ study. According to the Pioneer Press database of payments made by pharmaceutical companies to Minnesota physicians, AstraZeneca paid Dr. Adson $5,200 in 2004, $16,884 in 2005, $83,325 in 2006, $15,723 in 2007, $21,040 in 2009, and $9,371 in 2010. Most of these payments are listed as compensation for services, consulting fees, and compensation for speaking. (Dr. Adson’s CV states that he is a member of AstraZeneca’s speaker’s bureau.) In total, from 2004 to 2010 Dr. Adson was reportedly paid over $151,000 by AstraZeneca.

In addition, as a principal investigator, Dr. Adson received substantial funding from AstraZeneca. For example, in 2001-2002, Dr. Adson received $27,850 from AstraZeneca for the study, “Quetiapine as an Adjunctive Therapy for Persistent Anxiety in Those Receiving Treatment with an SSRI.” Dr. Charles Schulz was a co-investigator on this study and a co-author of the article that reported the study’s findings.

In 2006-2007, Dr. Adson received $113,000 for the AstraZeneca-funded study, “The Use of Quietapine (Seroquel) in the Treatment of Social Phobia: Effects on Cue Reactivity in Response to Virtual Reality Public Speaking Environment.”

In April 2006, Dr. Adson received $215,420 from AstraZeneca for the “Amethyst Study.” The full title for this study is, “A Multi-Center, Double-Blind, Randomized-Withdrawal, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) as Monotherapy in the Maintenance Treatment of Patients with Major Depressive Disorder Following an Open-Label Stabilization Period.” This AstraZeneca study appears to have been ongoing when the Board of Medical Practice hired Dr. Adson to investigate Dr. Olson.

Also in 2006, Dr. Adson received $101,000 from AstraZeneca for the “Opal Study.” The full title for this study is “A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) as Monotherapy in the Treatment of Adult Patients with Major Depressive Disorder.” This study was apparently in progress when the Board of Medical Practice hired Dr. Adson to investigate Dr. Olson.

In total, for these four studies – all initiated before the Board of Medical Practice hired Dr. Adson as a consultant in the investigation of the complaint filed against Dr. Adson – Dr. Adson received $457,270 in research funds from AstraZeneca.

Adding the funds Dr. Adson received as a principal investigator conducting AstraZeneca-funded studies to the speaker fees and other payments he was reportedly paid, Dr. Adson had received $608,813 from AstraZeneca by the time the Minnesota Board of Medical Practice hired him to investigate Dr. Olson. If it is true that Dr. Adson disclosed his conflicts-of-interest to the Board, as he claims, then you would have known at the time you hired him that you were selecting a recipient of substantial payments from AstraZeneca to investigate another psychiatrist that had received significant funding from AstraZeneca. Short of hiring an AstraZeneca employee to conduct the investigation – or perhaps hiring Dr. Olson to investigate himself – it appears to me that you could not have permitted a more egregious conflict-of-interest.

Of course, the payments Dr. Adson received from AstraZeneca before the Board of Medical Practice hired him are not the only cause for alarm about Dr. Adson’s ties to AstraZeneca. It is also worth noting that prior to his selection Dr. Adson, as with Dr. Olson, was a principal investigator for AstraZeneca-funded studies in which Quietapine (Seroquel) was the investigational agent administered to research subjects. Also of note, one of Dr. Adson’s co-investigators while conducting AstraZeneca funded research on Seroquel was Dr. Charles Schulz, Dr. Olson’s co-investigator on the CAFÉ study. In short, Dr. Adson was a direct financial beneficiary of a larger AstraZeneca-funded program of research that also benefited his departmental colleagues, Dr. Olson and Dr. Schulz. These psychiatrists were all fellow travelers in AstraZeneca-funded psychiatric clinical research that involved administering Seroquel to research subjects.

2) Dr. Adson was the Chair of the IRB that on May 26, 2004 reviewed Dan Markingson’s suicide. In addition, according to the Legislative Auditor’s report (p.25), “the consultant [Dr. Adson] served as one of the committee’s two ‘primary reviewers’” responsible for examining (p. 21) “Dr. Olson’s submissions about Markingson’s death and participation in the CAFÉ drug study.”

According to the Legislative Auditor’s report, (p. 20), “The University of Minnesota’s Institutional Review Board (IRB) conducted a superficial review of Dan Markingson’s suicide. The IRB did not review medical records, did not seek information from anyone other than Dr. Olson, and did not review information about Markingson’s suicide.” Had the Board of Medical Practice determined that Dr. Olson violated Minnesota laws, it is conceivable that subsequent independent investigations triggered by such a decision might have examined not only the superficial review the IRB committee chaired by Dr. Adson conducted but also Dr. Adson’s personal review of Markingson’s death. In short, all IRB members involved in reviewing Dan Markingson’s suicide and the care Dr. Olson provided Markingson should have been ruled as having a conflict-of-interest that rendered them unsuitable for the role of consultant to the Board’s investigation of Dr. Olson. These IRB members, by conducting such a superficial review, displayed their biases and apparent unwillingness to conduct a thorough investigation of the care Markingson received before he died.

3) Dr. Adson was a member of the IRB that approved Dr. Olson’s CAFÉ study. Had the Board of Medical Practice concluded that Dr. Olson violated Minnesota laws, it is possible that further investigations triggered by such a finding would have carefully scrutinized the University of Minnesota IRB’s approval of the CAFÉ study. For example, such an investigation might have explored whether the IRB should have permitted individuals expressing homicidal thoughts to participate in the CAFÉ study or required changes to the inclusion and exclusion criteria. All IRB members involved in approving the CAFÉ study, Dr. Adson included, should have been ruled as having a conflict-of-interest and deemed unsuitable for the role of consultant to the Board’s investigation of the complaint filed against Dr. Olson.

4) At the time the CAFÉ study was conducted, Dr. Adson was Director of the Ambulatory Research Center. This appointment means that Dr. Adson had administrative leadership responsibilities in the very setting where the CAFÉ trial was housed. Dr. Adson’s position is worth noting given the problematic conduct of the clinical research team for the CAFÉ study.

The Legislative Auditor’s report states (p. 23), “Dr. Olson inappropriately delegated tasks to Kenney [the clinical trial coordinator for the CAFÉ trial] and failed to provide her with adequate supervision.” According to both the Legislative Auditor’s report (p. 23) and the 2012 “Agreement for Corrective Action” taken against Kenney by the Minnesota Board of Social Work, Dr. Olson’s CAFÉ study coordinator “regularly performed tasks which were beyond her competence and scope of practice as a licensed independent clinical social worker”; “routinely initialed clinical documents with a physician’s initials; “failed to adequately address family concerns in a timely and effective manner;” failed to “document critical information regarding interventions and plans;” and completed documentation that “consistently fell below minimum standards of practice for a licensed independent clinical social worker.” While focused on Jeanne Kenney’s behavior, these findings generate serious concerns about Dr. Olson’s conduct as the principal investigator of the CAFÉ study. They also prompt questions about professional conduct that occurred in a trial housed at the Ambulatory Research Center at a time when Dr. Adson directed the Center. In particular, they call for an examination of the adequacy of Dr. Adson’s oversight of Dr. Olson and Jeanne Kenney.

In short, Dr. Adson was asked to investigate the conduct of a physician conducting a trial housed in a center where Dr. Adson had administrative leadership responsibilities. By selecting Dr. Adson as a consultant in the investigation of Dr. Olson, the Board of Medical Practice chose an investigator whose own conduct could conceivably have fallen within the scope of an independent investigation of the CAFÉ study, the clinical setting in which the trial was housed, and Dan Markingson’s death.

5) Dr. Adson and Dr. Olson were colleagues in the University of Minnesota Department of Psychiatry. Dr. Adson and Dr. Olson were co-workers who knew one another, shared research space in the same facility, reported to the same Department Chair, had common collaborators (such as Dr. Schulz), and presumably had a shared interest in the reputation of the Department of Psychiatry. As a faculty member based in the same academic department and clinical setting as Dr. Olson, Dr. Adson should not have been chosen by the Board of Medical Practice for its investigation of the complaint filed against Dr. Olson.

6) Dr. Adson and Dr. Olson both reported to Dr. Charles Schulz, Chair of the University of Minnesota Department of Psychiatry. While the Legislative Auditor’s report does not examine the Board of Medical Practice’s review of the complaint Mary Weiss filed against Dr. Schulz, it is important to note that Dr. Schulz, Dr. Adson’s direct superior, was a co-investigator on the CAFÉ study. Had the Board found that Dr. Olson violated Minnesota laws, such a determination might have had significant consequences for Dr. Schulz’s standing as a Department Chair and clinician-investigator. Dr. Adson’s subordinate relationship to Dr. Schulz should have precluded Dr. Adson from investigating Dr. Schulz’s CAFÉ study collaborator, Dr. Olson.

Now that Dr. Adson’s multiple conflicts-of-interest as well as the Board of Medical Practice’s complicity in tolerating those conflicts-of-interest have been exposed, you and your colleagues must take immediate action. Here is what you must do:

  • The Board of Medical Practice must issue an immediate apology to Mary Weiss for conducting a compromised investigation, wrongly dismissing her complaint, and falsely informing her that the Board hired an “independent expert consultant.” This apology should be delivered in person to Ms. Weiss, prominently displayed on the Board of Medical Practice’s website, and distributed to local and national news media outlets.
  • The Board of Medical Practice must promptly initiate and conduct a legitimate, non-conflicted investigation of Dr. Olson. The Board of Medical Practice must also publicly acknowledge that its prior “investigation” was illegitimate because it was compromised by conflicts-of-interest that were reportedly disclosed to the Board.
  • The Board of Medical Practice must contact President Kaler and other senior administrators at the University of Minnesota, inform them that the investigation of Dr. Olson was compromised, and warn them that they must stop using the Board’s dismissal of Mary Weiss’ complaint to support their claims that the care Dr. Olson provided Dan Markingson before Dan’s death was thoroughly investigated. University officials must be advised that the Board of Medical Practice’s investigation was “compromised and suspect,” and the Board’s dismissal of Mary Weiss’ complaint was unjustified. They should be told to stop making misleading statements that the Board “found no fault” with Dr. Olson and the University of Minnesota.
  • All staff members and/or Board members who knew about Dr. Adson’s multiple conflicts-of-interest and allowed him to serve as a consultant in the investigation of Dr. Olson should be immediately removed from their positions for dereliction of duty and failure to protect the public. Individuals willing to tolerate such conflicts-of-interest have no business being associated with the Board of Medical Practice.
  • The Board of Medical Practice must request and obtain an independent investigation that examines whether the Board has compromised other investigations of complaints by hiring consultants with conflicts-of-interest. The Office of the Legislative Auditor or another comparable body should be provided with the financial resources, staff, and documents required to conduct such an investigation. Findings from this inquiry should be reported to the Minnesota Legislature in case new legislation is needed. Absent such an independent inquiry, the Board of Medical Practice’s handling of Mary Weiss’ complaint leaves unanswered profoundly disturbing questions about the credibility and integrity of the Board of Medical Practice’s investigations of complaints filed against Minnesota physicians.

I suspect that you will be tempted to hide behind the Data Practices Act and claim that you cannot comment on the compromised investigation or even admit that there was an investigation of Dr. Olson. With Dr. Adson’s multiple conflicts-of-interest and the Board of Medical Practice’s compromised investigation of Dr. Olson now a matter of public record, such a response will fail to address the growing stench that is coming from the Board. I urge you to take all steps required to fulfill the Board of Medical Practice’s duty to protect the public, give Mary Weiss the apology that she deserves to receive from you, ensure that this compromised review is followed by a legitimate investigation, and restore a sense of integrity and competency to the Board.

Yours sincerely,

Leigh Turner, PhD

Associate Professor

University of Minnesota Center for Bioethics

cc:

Jerry Menikoff, Director, Office for Human Research Protections, DHHS

Kristina Borror, Director of the Division of Compliance Oversight, Office for Human Research Protections

Sean Kassim, Director, Office of Scientific Investigations, FDA

Catherine Parker, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, FDA

Arne H. Carlson, Former Governor of Minnesota

Terri Bonoff, Minnesota Senator, Chair of the Higher Education & Workforce Development Committee

Dan Schoen, Representative, Minnesota House of Representative

Carl Elliott, Professor, University of Minnesota Center for Bioethics

Trudo Lemmens, Professor, Faculty of Law, University of Toronto

Michael Carome, Director, Public Citizen Health Research Group

James Nobles, Legislative Auditor for the State of Minnesota

Eric Kaler, President, University of Minnesota

Brian Herman, Vice President, University of Minnesota

Brooks Jackson, Vice President, Health Sciences & Medical School Dean, University of Minnesota

Bruce Blazar, Associate Vice President for Clinical & Translational Science, University of Minnesota

William Donohue, General Counsel, University of Minnesota

Keith Dunder, Legal Counsel, University of Minnesota Academic Health Center

Susan Berry, Chair, University of Minnesota IRB Executive Committee

Debra Dykhuis, Executive Director, University of Minnesota Human Research Protection Program

Richard Beeson, Chair of the Board of Regents, University of Minnesota

Dean Johnson, Vice Chair of the Board of Regents, University of Minnesota

Thomas Anderson, Regent, University of Minnesota

Laura Brod, Regent, University of Minnesota

Linda Cohen, Regent, University of Minnesota

Thomas Devine, Regent, University of Minnesota

Michael Hsu, Regent, University of Minnesota

Peggy Lucas, Regent, University of Minnesota

David McMillan, Regent, University of Minnesota

Abdul Omari, Regent, University of Minnesota

Darrin Rosha, Regent, University of Minnesota

Patricia Simmons, Regent, University of Minnesota

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