Mary Weiss' Troubling Loss:

Extended Coverage

From the Minnesota Daily:

The Minnesota Daily Editorial Board is all about outreaching. So, in response to the Academic Health Center's response to University bioethics professor Carl Elliott's "Media Outreach," aka a damning article in one of the best investigative publications in the country, below are some more media outreaches about the Dan Markingson case.

Indeed, it wouldn’t make much sense of us to not provide you with a sort of online map of the Dan Markingson case after arguing last week that it deserves ongoing public scrutiny. A good place to start in looking is Jeremy Olson and Paul Tosto’s newspaper series in the Pioneer Press.

Dan, 26, was checked into University of Minnesota Fairview Medical Center in November of 2003 after having apparent delusions, where he saw Dr. Stephen Olson. It was the first time Dan was checked into a hospital for delusions, and Olson diagnosed him with possible bipolar disorder or schizophrenia, according to court records. He recommended that Dan be committed and a judge ordered Markingson to, under various conditions, a stay of commitment for six months.

Olson, as it happened, was also a principle investigator on a study, called the CAFE Study, looking at first episode psychosis testing the efficacy and tolerability of three anti-psychotics already FDA-approved and on the market—a study that researchers were being pressured to enroll more patients, according to Elliott’s article. A week after Olson noted Dan “lacked insight into his current problems,” Olson asked Dan if he wanted to be in the study, raising the question of informed consent.

The study—which Elliott’s article states generated $327,000 for the department—was double blind, meaning neither the patient nor doctor knew what medication Dan would be taking, and bringing into question whether Olson had Dan’s best medical interests in mind. Olson, as Dan’s doctor and the leader in a study in which Dan enrolled, had conflicting interests between being loyal to both the study and Dan’s safety. Thankfully, in 2009, the Minnesota Legislature passed a law prohibiting this obvious conflict. It’s called Dan’s law.

The medication turned out to be Seroquel, manufactured by AstraZeneca, which was sponsoring and funding the study. Mary Weiss, Dan’s mother, had warned researchers throughout the six-month study that she was concerned about Dan’s safety, including to Dr. Charles Schulz, one of the study’s coordinators who heads the University’s psychiatry department. In clinical trials on vulnerable and potentially suicidal populations, it’s our opinion that researchers should heed any warnings about a patient’s behavior. As Elliott told City Pages, advice from his brother, a psychiatrist : "If a mentally ill young man's mother keeps calling, begging you to take her son out of a study because she thinks he is going to commit suicide, you don't just ignore her. You call 911." But that didn’t happen here. Dan eventually stabbed himself to death in a bathtub in May of 2004, when he was still enrolled in the study and taking the medication.

Elliott expands on MPR.

The FDA, in an investigation, which is attached below, said the University did nothing illegal. One interesting question is about the role of the University's Institutional Review Board in this case. Should it have been more active in overseeing the CAFE study? If not, as it claimed in court, then what exactly is the role of an IRB, if not to protect human research subjects?

Weiss took the researchers, the University of Minnesota and AstraZeneca to trial in a wrongful death case in 2007. But the court dismissed the case in 2008, saying Weiss had failed to establish a causal link between Dan’s suicide and the medication. (She says blood tests she requested after the case showed that Seroquel was indeed in his blood). Remarkably, the court, as MinnPost.com notes, also said there was no case law or statute supporting the contention that a pharmaceutical company has a duty to put the interests of research subjects above that of the company itself. The court file number is 27 CV-07-1679 if you want to go to the Hennepin County District Court and do some digging.

The University demanded that Weiss pay it $57,000 in out-of-pocket costs after the case; in the legal world, that’s called squeezing the plaintiff. The University could have thought its chances were slim on appeal, so they demanded Weiss, a single mother on a Post Office salary, pay its legal fees. Some of the fees the University wanted Weiss to pay included fees for depositions, expert services along with, according to court records, airfare, meals, parking and hotel rooms. Weiss says that a law clerk deemed only about $1,000 of those fees justifiable. Eventually, Weiss settled with the University, getting $75,000 from Olson, not enough to cover her legal costs. She agreed not to appeal.

Olson, of course, is still working as an associate professor in the Department of Psychiatry. Schulz , another principle investigator in the study, is still the head of the department. That should not be surprising: ethics obviously isn’t a huge concern over at the Academic Health Center or Medical School. The University will point to their new conflicts of interest policy, whereupon it also deserves mention that the guy who helped write that policy, Leo Furcht, is the same person who the University punished for funneling about half a million of research dollars to a firm he owned, which he later sold for $9.5 million.

There’s more. In 1995, Elliott notes, Dr. John Najarian’s illegal manufacturing of an immunosuppressant drug without FDA approval brought the University sanctions from the National Institute of Health. He’s still listed as a clinical professor of surgery in the University’s department of surgery. And let’s not forget Dr. David Polly, the chairman of spinal surgery at the University who, as a Senate investigation revealed, failed to disclose a cool $1.2 million in consulting money from Medtronic. He’s still a professor of orthopedic surgery at the University.

Maybe the University’s ongoing transgressions with conflicts of interest lay not in an inadequate oversight system. Maybe it’s just the people at the Academic Health Center and Medical School themselves, most of them brilliant medical minds, who, on the other hand, have sanctioned a culture wherein dangerous conflicts of interest have arisen more than a few times.

With that, we'll leave you with a Monday quote from President Bruininks:

"It's very important for the University community to speak forcefully, and, I would argue, inspirationally, about the importance of being accountable for our conduct and accountable for the work we do. And resolving issues that have anything to do with conflict of interest is, in my judgment, a very important aspect of building a highly ethical culture that has been characteristic of the University."

As noted here many times, President Bruininks talks a good game...