A group of University of Minnesota professors want the board of regents to investigate the suicide of a patient enrolled in a university-run drug study.
Led by Dr. Carl Elliott, the professors demand the regents appoint an independent outside panel of experts to examine the death of Dan Markingson, a mentally ill patient who killed himself after taking an experimental psychiatric drug developed by AstraZeneca. The professors accuse the school of several ethics violations, including financial conflict of interest and enrolling Markingson even though he may have been too sick to consent.
“Patients participating in research studies at the University of Minnesota need to be confident that the university is doing everything it can to protect them from harm,” stated a Nov. 29 letter to the regents board. “While it is understandable that some of our colleagues will have little interest in revisiting the case and the ethical questions it raises, we are persuaded that there is a disturbing and unjustifiable gap between how the University responded to this death and the careful, critical investigation it warrants.”
Markingson committed suicide in May 2004 after taking Seroquel, a psychiatric drug developed by AstraZeneca. Mary Weiss, Markingson’s mother, accused the university of of forcibly enrolling her son in the clinical trial even though Markingson was under an involuntary commitment order and may have been mentally incompetent to consent to the treatment.
A series of stories in the St. Paul Pioneer Press and Mother Jones magazine, the latter written by Elliott, suggested an improper financial relationship between university researchers and AstraZeneca, including incentive payments to recruit and retain patients for the study instead of providing standard therapy.
University officials deny the accusations, noting the Food and Drug Administration, Minnesota Attorney General’s Office and Board of Medical Practice all cleared the school.
“None found fault with the University, none found fault with the involved faculty, and none found any causal link between the … trial and the unfortunate death of Dan Markingson,” the university’s general counsel, Mark Rotenberg, wrote in response to the Mother Jones story.
In addition, a federal judge dismissed a lawsuit brought by Weiss.
“Faculty in our department of psychiatry have made great progress in pursuit of effective treatments for mental health disease,” Rotenberg wrote. “The department’s work — much through clinical trial efforts — has made a significant impact through its community clinical outreach and treatment programs. However, these conditions remain today among the most difficult to manage and treat. It is that challenge which our psychiatry faculty is seeking to address with its clinical research.”
In a separate interview, Elliott, who recently wrote a book critical of the drug industry, said the FDA investigation did not address key information.
“There is lots that the FDA report missed, and the FDA refuses to answer questions,” Elliott wrote in an e-mail. “The FDA did not mention the conflicts of interest, the financial incentives to enroll subjects and keep them in the study, the failure to exclude subjects at risk of homicide, the fact that Mary Weiss had tried for months to get her son out of the study, or the fact that Dan Markingson had been threatening murder when he was recruited into the study.”
“Bizarrely, it also concluded that ‘there is nothing different about this subject than others enrolled to suggest that he could not provide voluntary, informed consent,’ ” Elliott wrote. “This, despite the fact that only a few days earlier, the investigators had judged him incapable of consenting to antipsychotic drugs.”
Elliott also said new evidence suggests the company rigged the trial to show positive results.
Last year, the Star Tribune in Minneapolis reported that court documents showed AstraZeneca claimed its drug was superior to standard treatments for schizophrenia, even though the drug maker knew research did not back the claim.
Dr. Charles Schultz, chief of psychiatry at the university, presented research backing AstraZeneca’s claims to a medical conference. Schultz claims the company never shared its concerns with him.