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U of M professor slams administration for 'cover-ups' of drug trial scandals

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A bioethics professor at the University of Minnesota has written a New York Times column hugely critical of the U's crisis-hit psychiatry department, saying college leaders are more interested in 'covering up' ethical breaches than dealing with them.

Carl Elliott's op-ed comes after the U of M stopped enrollment in Department of Psychiatry studies after two reviews into the 2004 death of anti-psychotic drug trial patient Dan Markingson highlighted "serious ethical issues," finding he was enrolled onto the trial against his mother's wishes and while under threat of being committed if he didn't take part.

But Elliott, who has been at the U of M for 18 years, said the Markingson case was just one of a series of blunders within the department over the past 25 years, and he accused the U's administration of brushing scandals under the rug rather than owning up to them. He writes:

"The problem extends well beyond the department of psychiatry and into the university administration. Rather than dealing forthrightly with these ethical breaches, university officials have seemed more interested in covering up wrongdoing with a variety of underhanded tactics."

He added:

 "Here at the University of Minnesota, we have reached a critical point. Two months ago, after two blistering external investigations, university officials finally agreed to suspend recruitment for psychiatric drug studies. Yet they still refuse to admit any serious wrongdoing."

The fallout from the Markingson reports has continued in recent weeks, with one of the doctors at the center of the controversy, Dr. Charles Schultz, stepping down a chair of the psychiatry department in April and resigning from a project integrating the U's medical operations with Fairview Health Services.

The report by the Minnesota's legislative auditor accused the U of making "misleading and inaccurate statements" about past reviews of Markingson's death, and criticized previous comments dismissing the need for further investigation.

Markingson was 27 when he took his own life in May 2004 while participating in a U clinical drug study funding by pharmaceuticals giant AstraZeneca.

Elliot highlighted other department failures, including two disqualifications from the Food and Drug Administrations of U psychiatrists involved in drug studies, and the enrolling of "illiterate Hmong refugees in a drug study without their consent."

Is private funding raising conflicts of interest?

One key concern that Elliott raised in his critique is the level to which private funding is driving university research – not just in psychiatric departments, but in all aspects of medical research, which has now become a "global, multibillion-dollar business enterprise."

He said it gives rise to ethical issues not only because massive corporations "have plenty of money to grease the wheels of research," it's that researchers themselves are "given powerful financial incentives to do unethical things," such as pressuring vulnerable people to enroll in studies, or keep them in even if they're not doing well.

The Star Tribune has reported on Tuesday that researchers at the U of M are "leaning more" on business, industry and other private benefactors to carry on their work – which raises "questions of who's setting the research agenda."

The newspaper notes that even though 74 percent of the U's research spending is from taxpayer funding, projects funding privately are more likely to raise questions over conflicts of interest – highlighting a project in which a lab found 3M chemical workers were not at higher risk of getting cancer, a $450,000 study paid for by 3M.

The U's vice-president of research Brian Herman told the newspaper they have safeguards in place to ensure the integrity of academic research.

But in his NYT piece, Elliott described the current methods of research oversight being used across the country as "antiquated" and "bureaucratic" and calls for an overhaul of the Institution Review Board (IRB) system that is supposed to protect human test subjects and root out conflicts of interest.

He called on the creation of "oversight bodies fully independent – financially and institutionally – of the research they are overseeing," giving them the power to punish researchers who break rules and research institutions who cover up wrongdoing.

Although reforms of IRBs would have to happen on a federal level, the U of M has released a plan to strengthen its IRB process by adding more members, compensating them and having attendance requirements – as well as creating an IRB panel to evaluate the safety of studies with vulnerable patients who have limited or fluctuating "capacity to consent."

Responding to BringMeTheNews' request for comment, the U also said that it has recently released a draft plan to strengthen its human subjects research, which is available for public comment. You can find the report here.

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