And The Angels Wept....

Some background:

The Markingson Case at the Univrsity of Minnesota: Follow the Money



 From the Star-Tribune:
 JEREMY OLSON

Sanctions imposed in 2004
U drug trial death

 Social worker faulted over care of a 27-year-old
in a U study who killed himself.  

Dan Markingson's mother has waited nearly a decade for researchers in a University of Minnesota drug study to be held accountable for the suicide of her son.

A small piece of that accountability came when state regulators and former U of M social worker Jean Kenney reached an agreement about actions she must take as a result of errors she made in Markingson's care during the study.

"It is the first public acknowledgement of the wrongs that were done," said Mike Howard, a close friend to Markingson's mother, Mary Weiss.

Markingson's death in May 2004, during a clinical trial of antipsychotic drugs, has had ripple effects at the university, including a lawsuit, a federal probe and an overhaul of the school's ethics standards for clinical trials.

But no one involved in the fateful study had suffered any sanctions until now.
Even the action regarding Kenney, issued Friday by the Minnesota Board of Social Work, isn't a disciplinary action; it is listed only as an "agreement for correction action." The unusual licensing document requires that Kenney complete 18 hours of training and write a report on whether it alters her view of her conduct in the drug trial.

In some ways, the document raises more questions about the psychiatrists who led the study -- and why they put Kenney in a role beyond her scope of training -- than about Kenney herself, Howard said.

"It's a pretty big black mark over there on how things were being done,'' Howard said.

Kenney said she was simply "acting under ... supervision and in accordance with the protocols that had been approved," according to the document. Her attorney, David Alsop, said Kenney reached the agreement with the social work board in order to "get this behind" her.

The document asserts that Kenney wrote incorrect drug dosages and made other mistakes in Markingson's records. She also made clinical observations about Markingson, and whether the drugs caused him side effects, that were beyond her scope of practice as a social worker, the order said. Kenney also was criticized for failing to adequately respond to the concerns of Markingson's family -- his mother at one point questioned whether her son would have to die before she would be taken seriously -- or recording how information gathered about Markingson was used in his treatment planning.

Alsop said Kenney disagrees with most of the statements in the document, but acknowledges the recordkeeping errors. "She did" make those errors, he said, "but it didn't affect the tragic outcome of this case."

U was cleared by FDA

The university has been held blameless in Markingson's death. The 27-year-old, who had schizophrenia, had been in the trial for months when he killed himself in a West St. Paul group home.

The so-called CAFE study was funded by drugmaker AstraZeneca to compare three antipsychotic drugs, including the drug Seroquel, which Markingson was taking.

The university and AstraZeneca were dismissed from a lawsuit by Markingson's mother. An investigation by the U.S. Food and Drug Administration didn't fault them either. The lead psychiatrist for the study, Stephen Olson, settled the lawsuit for modest costs but has faced no disciplinary action.

Markingson's relatives aren't the only ones who raised concerns, though. The mental health ombudsman for the state of Minnesota questioned how Markingson was recruited into the study.

A judge had ordered Markingson to comply with the recommendations of his psychiatrist, Olson, or face inpatient commitment. Markingson agreed to participate in the study shortly after that court order was issued.

The Minnesota Legislature has since made it illegal for psychiatrists to recruit their own patients into their own clinical trials.

U of M ethics Prof. Carl Elliott has criticized his own institution for the study. On Monday, Elliott called the Kenney agreement "alarming." He has questioned whether Markingson ever had the mental capacity to consent to the study. But even if his written consent was valid at first, the document suggests that it was invalidated when the university failed to notify him of risks of taking Seroquel that were discovered during the trial.

"The university ought to be looking into this," Elliott said.

Officials with the U and the social work board weren't available Monday, a federal holiday. In previous correspondence, university officials have defended their psychiatrists and cited the lack of investigatory findings as reasons to support them.