“The University constructed a defense to deny liability by claiming immunity. I think that defense evolved or you might say devolved into a strategy to simply avoid any accountability or responsibility and to deny that there were any serious ethical issues. And we found that serious ethical issues and conflicts of interest just permeated this case.”
James Nobles, legislative auditor, March 20, 2015
The University of Minnesota, like many other universities, has a sizable clinical research program that tests experimental drugs for safety and efficacy. The understanding between the companies that develop these drugs and the consuming public is that such drugs are carefully tested on humans and that these clinical trials must comply with strict ethical, scientific and regulatory standards. These research protections were developed after a series of research scandals that involved abusive treatment of vulnerable populations such as economically disadvantaged communities, prisoners, children, and individuals suffering from mental illness.
Ever since the violent suicide of Dan Markingson in 2004, the administration of the University of Minnesota has received repeated calls for the release of more details about the care and protection afforded the victim. These calls have come from faculty members at the university, from local community members and from researchers from around the world. But instead of being transparent and forthright, the administration created a standard response similar to that expressed by the university’s former general counsel, Mark Rotenberg: “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 any of our faculty.”
If correct, that would be a most understandable and appropriate response. However, it falls far short of the truth. Consider this:
• State attorney general’s office: Never conducted any such investigation.
• Hennepin County District Court: In a lawsuit brought by Mary Weiss, the mother of Dan Markingson, the judge ruled that the university’s Institutional Review Board (IRB) was “statutorily immune from liability.” But immunity is a far cry from exoneration. As Matt Lamkin, an alumnus of the University of Minnesota’s graduate program in bioethics and a current member of the faculty at the University of Tulsa Law School, has noted: “to suggest that the University of Minnesota was exonerated in this lawsuit is like a diplomat who got drunk and ran over a child claiming he was ‘exonerated’ by diplomatic immunity.”
• The University of Minnesota Institutional Review Board: Richard Bianco, the university official responsible for overseeing research subject protection, stated under oath in his deposition that the university had not done any investigation into Markingson’s death.
• The Minnesota Board of Medical Practice: The legislative auditor’s report released last month describes the board’s review of Markingson’s death as “compromised” because the “independent investigator” the board hired had “numerous conflicts of interest.” (Dr. David Adson, a colleague of the psychiatrist under investigation, also received more than $585,000 from the drug industry and more than $145,000 from AstraZeneca, whose drug was being tested in the study in which Markingson committed suicide.)
• The U.S. Food and Drug Administration: The FDA did review the case, and its report is public. Critics have taken exception to the narrowness of scope in that the report failed to examine the conflicts of interest, enrollee mistreatment, the unresponsiveness of Markingson’s doctors to his mother’s concerns and the civil-commitment order used to pressure Markingson into enrolling in the study.
Despite the obvious falseness of the claim of numerous and exhaustive investigations, the university president, Board of Regents and various administration officials all have used this cover as a hammer against those who dissented and called for an independent investigation.
Unfortunately, this weapon worked all too well. Time and again, news stories covering the Markingson case contained a paragraph citing these numerous and thorough investigations and a finding of no fault. What was missing was an effort to fact-check that claim.
No one wants to believe any administration of higher education would engage in conduct not representative of the highest standards of truthfulness. As a society, we view politicians with a certain skepticism, but tend to have the opposite view when it comes to religious leaders, judges and educators.
But the reality is that any management system can deny wrongdoing and block calls for an independent investigation. When Eric Kaler took the reins as president of the university in 2011, he had already been sent material by Dr. Carl Elliott, a critic of the university’s handling of the Markingson case and faculty member at the Center for Bioethics. In his 2010 article for Mother Jones magazine, Elliott wrote about the issues of poor standards, conflicts of interest involving an all-too-cozy relationship with drug companies, the lack of independent oversight and the way the threat of involuntary commitment was used to coerce Markingson into the drug study.
During his first year at the university, Kaler had to make a major decision. Prudent management would have involved meeting with Elliott, learning about the specific ethical issues related to Markingson and broader concerns about psychiatric clinical research, and dealing with the growing scandal. But Kaler chose instead to perpetuate the prevailing coverup. He opposed any independent review, never responded to the charges made in the media, ignored or dismissed critics, and stood firm in his belief that it would all blow over.
In so doing, President Kaler tarnished his office and abandoned the principles of truthfulness, openness and integrity. He also frittered away the moral authority that is so essential to governance. His failure to provide ethical leadership permitted the scandal to grow. The result was more stonewalling of requests for information from faculty and media and increased attempts by administration officials to demonize critics, including referring to some scientists as “wackos.”
Perhaps most troubling is the culture of intimidation associated with the Department of Psychiatry. The university’s own external review refers to this culture as a “climate of fear.” Extending from that department to the university’s senior management team, the apparent goal was to make certain no one questioned authority.
On June 16, 2014, I met with Kaler and Board of Regents Chairman Richard Beeson, and went over all the materials covering conflicts of interest, the falseness of their claims of endless investigations, as well as the damage being done by news articles highly critical of the university’s handling of the Markingson scandal. Kaler was quiet and rarely asked a question. As a result, I focused more attention on the lack of oversight and leadership provided by the Board of Regents and its failure to examine the circumstances of Markingson’s death. Given the deeply troubled history of research in the Department of Psychiatry over the past 25 years, a history that includes six suicide deaths, untold injuries, the conviction and imprisonment of one professor, the barring of two researchers by the FDA, and a barrage of poor publicity, I was stunned by Beeson’s response that this matter “has not risen to the level of our concern.”
Last week, the university announced that Charles Schulz has decided to resign as chairman of the Department of Psychiatry. He will retain his position as executive medical director, and his faculty appointment. The news release announcing his departure made no mention of the department’s troubled record, or the research controversies in which Schulz has been personally involved. Rather than removing him as department chairman and taking additional disciplinary action, the university has provided Schulz with a soft landing.
The very administrators and regents responsible for the current debacle now promote themselves as trustworthy agents of change. We will not see meaningful reform of research on human subjects, nor the restoration of prestige at the university, so long as Kaler, Beeson and other leaders responsible for years of denials and stonewalling remain in charge.
Arne H. Carlson was governor of Minnesota from 1991-1999.