For nearly eleven years, University of Minnesota officials defended the conduct of its researchers, despite significant public criticism,[1][2] numerous news reports,[3][4][5][6][7] and pressure for an external investigation.
[14] Dan Markingson was raised in St. Paul, Minnesota by his mother, Mary Weiss, and earned a degree in English literature from the University of Michigan.
[34] The Pioneer Press series raised concerns about the financial ties Olson and his CAFÉ study co-investigator, Charles Schulz, the Chair of the Department of Psychiatry, had to AstraZeneca and other pharmaceutical companies.
[35][36] In August 2010, Mother Jones magazine published an article on the Markingson case by Carl Elliott, a professor in the University of Minnesota's Center for Bioethics.
[41] In November 2012, the Minnesota Board of Social Work issued a “corrective action” against the CAFÉ study coordinator, Jean Kenney, for numerous lapses.
Among its findings were that Kenney had performed medical tasks beyond her competency and failed to inform Markingson of new metabolic risks of quetiapine (Seroquel) when the study sponsor notified investigators.
[46] Six months later, another University of Minnesota research subject, Robert Huber, revealed publicly that he had been recruited into a study of an unapproved antipsychotic drug, bifeprunox, under circumstances similar to those of Dan Markingson.
[49] On February 27, 2015, the university released an external review commissioned in light of the Faculty Senate resolution and managed by the Association for the Accreditation of Human Research Protection Programs.
On April 17, 2015, the New York Times reported that Charles Schulz, who had recently stepped down as Chair of the Department of Psychiatry, had enrolled two residents of a sex offender facility in a study of quetiapine (Seroquel) for Borderline Personality Disorder.
[58] On February 10, 2016, a consultant hired by the University of Minnesota found over forty critical violations of research and safety policy in the Department of Psychiatry.
[59] The consultant also reported being verbally abused and intimidated by faculty members, and said university administrators had instructed her not to put her critical findings in writing.
[60][61] In April 2016, Rep. Cindy Pugh, Rep. Connie Bernardy, and Rep. Abigail Whelan, members of the Minnesota House of Representative Higher Education Finance and Policy committee, introduced a bill that would have research studies in the Department of Psychiatry monitored by the Ombudsman for Mental Health and Developmental Disabilities.
Critics also assert that the Markingson case raises questions about the responsibility of institutional leaders to investigate credible evidence of the mistreatment of research subjects and take steps to remedy the problems.
When journalist Peter Aldhous compared Food and Drug Administration records with disciplinary actions by state medical boards, he found dozens of doctors conducting research studies after they had been sanctioned or stripped of their licenses for substance abuse, fraud, negligence, or mistreatment of their patients.
[93] A report by the Office of the Inspector General of the U.S. Department of Health and Human Services found that the FDA inspects less than one percent of research sites, often long after questionable studies have been completed.
Critics argue that Institutional Review Boards are understaffed and under-qualified, that they are excessively bureaucratic, and that they attempt to restrict research outside their mandate and expertise.
[96][97][98] Many Institutional Review Boards, such as the one at the University of Minnesota, are staffed by colleagues of clinical investigators whose studies are being evaluated, raising concerns about personal conflicts of interest.
Others, known as “independent” or “commercial” Institutional Review Boards, are funded by research sponsors themselves, an arrangement that arguably presents a financial conflict of interest.
[99] Two separate sting operations have found commercial IRBs willing to approve phony research studies deliberately designed to be risky or fraudulent.
[100][101] The architecture of the current system of human subject protection in the United States was put into place after public outcry over scandals such as the Tuskegee syphilis experiment.
[102] Elizabeth Woeckner, president of Citizens for Responsible Care and Research, a non-profit watchdog organization, has said, “These are regulations for a world that doesn’t exist anymore.”[103]