The University of Minnesota’s Board of Regents has rebuffed a request by eight bioethicists to appoint an outside panel of experts to investigate the ethical issues raised by the case of Dan Markingson, a young man who committed suicide in 2004 while enrolled in a psychiatric research study at the U of M.
In a letter dated Feb. 7 and released Monday, the board noted that “extensive reviews” of the case had been conducted by “a number of independent experts and government units,” including the U.S. Food and Drug Administration, the Hennepin County District Court, and the Minnesota Board of Medical Practice.
“Each and every one of these reviews resulted in the same conclusion: there was no improper or inappropriate care provided to Mr. Markingson, nor is there evidence of misconduct or violation of applicable laws or regulations,” the letter said.
“[W]e do not believe further University resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies,” the board concluded.
“Once again, the university had a chance to do the right thing, and once again it failed,” said Dr. Carl Elliott, a professor of bioethics at the U of M and a signator to last November’s letter to the Board of Regents, in an e-mailed statement to MinnPost. “That’s not surprising, but it’s still disappointing.”
“I wasn’t all that surprised either,” said Leigh Turner, another signator and an associate professor in the center for Bioethics, the School of Public Health and the College of Pharmacy, in a phone interview. “It seems to be in keeping with previous strategies to manage this case.”
Turner noted that the board solicited input only from U of M general counsel Mark Rotenberg. “You’re getting a very circumscribed take on the issue,” he said. “[General counsels] generally play a risk-management role. What you’ve got here is a letter that’s an exercise in risk management.”
“The general counsel keeps repeating that this matter has already been investigated and the university has been cleared, but it is precisely those investigations that have been called into question,” said Elliott. “This is exactly the reason why we have been calling for an independent investigation.”
Markingson was 26 years old and experiencing psychotic episodes when he was recruited into a U of M clinical trial of the antipsychotic drug Seroquel (quetiapine). The study was funded by the drug’s manufacturer, AstraZeneca, and the U of M psychiatry department earned $15,648 for each patient it enrolled in the trial. In addition, the two U of M psychiatrists who led the study, Drs. Charles S. Schulz and Stephen C. Olson, had personally earned hundreds of thousands of dollars from various drug companies, including AstraZeneca.
“Given all the press about this case, it’s stunning that the university has not even addressed the fact that Dan Markingson was under an involuntary commitment order when he was recruited into the study, and had been ordered to follow the treatment recommendations of his psychiatrist,” said Elliott in his e-mail statement. “This practice is now illegal in Minnesota. The state legislature has banned it. Even so, the university apparently does not think the matter is important enough to investigate.”
Last year, AstraZeneca agreed to pay $520 million to settle a federal investigation into its illegal marketing of Seroquel. Part of that investigation had concerned AstraZeneca’s payments to physicians.
“The unsealed documents in that litigation implicated our Department of Psychiatry — in fact, they implicated Charles Schulz,” said Elliott. “… Yet again, the university apparently does not think this is worrying enough to look into.”
Corporate revenue streams
The U of M adopted a new conflict-of-interest policy in August, which covers all researchers in the Academic Health Center, including those in the Department of Psychiatry. But that policy doesn’t stop pharmaceutical and other companies from pouring money into the university, said Turner.
“Universities are feeling cash-crunched,” he said. “Many are getting less money from state budgets. They’re looking for other revenue streams.”
The U of M Board of Regents acknowledged the importance of these revenue streams in its letter.
“In an era when public funding of our University and its research is limited, we must recognize that critically important medical and health research requires substantial private investment, both from donors and from corporate sponsors,” the letter stated. “Those funding sources provide great opportunities — and pose significant challenges — for the University. We believe our faculty is ideally suited to engage in a rigorous, open, and honest exploration of these opportunities and challenges, and the impact they may have for the integrity of our research mission.”
Recent research has shown, however, that corporate-sponsored medical studies are frequently designed to place the drug being investigated in the best light.
“The results typically favor the company,” said Turner. Thus, even participating in such studies raises conflicts of interest for researchers and their institutions, he said.
Listing the conflicts of interest of U of M researchers and the university on a website is not enough, Turner added. “Simply acknowledging that you’re taking money from drug companies doesn’t eliminate the conflict of interest,” he said.
Industry-sponsored studies “create a financial architecture where the incentives are to recruit and retain” patients, he explained. “But what if it’s in the patient’s interest to be dropped from the study and receive standard care?”
Nor is Turner impressed with the Board of Regent’s suggestion in its letter that the U of M community “engage in further discussion about these wider issues.”
“They’re saying, ‘Let’s just create a little space where those of you who are concerned can talk about it,’” he said. “That’s not going to resolve these issues, for there’s no attempt to deal with any of the structural problems.”