Wednesday, December 10, 2014

As the whistle blows, Kaler covers his ears

For reasons related to print space, my letter to the Minnesota Daily this week was published in two parts, on two days (here and here.)  This is the full letter.

There was something sadly familiar to Fairview Hospital whistleblower Niki Gjere’s revelations on KMSP-TV on Nov. 25. It was not just that Gjere confirmed through firsthand, eyewitness testimony the stunningly unethical circumstances under which a mentally ill young man was pressured to join a controversial University of Minnesota psychiatric study. It was that she has tried to get the truth out for years and been repeatedly dismissed or ignored by hospital and University officials.

Gjere, a senior psychiatric nurse, was working on a locked ward for psychotic patients at Fairview when Dr. Stephen Olson, the director of the schizophrenia program, persuaded a severely ill 26-year-old named Dan Markingson to join a lucrative, pharmaceutical industry research study of antipsychotic drugs. Not only was Markingson floridly psychotic (according to a court-appointed examiner’s report, he believed his mother was a lizard), but he was also under a civil commitment order. That order legally compelled him to obey Olson’s treatment recommendations.

Dan’s mother, Mary Weiss, protested that her son was unable to give proper informed consent to a research study under such conditions. Gjere says she protested as well. Their objections were ignored. Five months into the research study, Dan’s nearly decapitated corpse was discovered in the bloody bathroom of a halfway house, along with a box cutter and a suicide note.

Despite evidence of coercion, conflicts of interest and stunningly careless medicine, University officials have claimed that Markingson’s death has been thoroughly investigated and the University was cleared. Under scrutiny, those claims have largely evaporated.

In a deposition, the head of research protection at the University has admitted that to his knowledge, not even the University itself had ever investigated Markingson’s death. Only an FDA inspector looked into the issue, and according to Gjere, that inspector never spoke to her. Nor did she speak to Mary Weiss, who had tried for months to get her son out of the research study.

Gjere decided to speak out after a second disturbing incident involving another seriously ill patient at Fairview. The patient, identified as Robert, says that Olson pressured him into a pharmaceutical industry study of an unapproved antipsychotic drug called bifeprunox. “I was incompetent and didn’t know what I was doing,” Robert told KMSP. “Then they say you have a giant medical bill, and if you do the research, you won’t have this giant medical bill.”

The side-effects of Bifeprunox were so severe that Robert considered suicide. He went to the Fairview emergency room three times, yet Dr. Stephen Olson apparently dismissed his symptoms as “psychosomatic.” Robert says he was told that bifeprunox was safe. But the FDA soon rejected the drug, asking the sponsor to look into the death of a research subject who had died of liver failure shortly after taking it. Several months later, the sponsor halted all bifeprunox studies.

What is bafflingly familiar now is the point-blank refusal of University of Minnesota officials even to listen to these shocking revelations. Niki Gjere tried to bring her concerns to University President Eric Kaler. Kaler refused to meet her and sent her to another administrator, who did nothing.

Kaler has also refused my own requests for a private meeting. When my bioethics colleague, Leigh Turner, accompanied former Governor Arne Carlson to a meeting with Kaler and Richard Beeson, the Chair of the Board of Regents, Kaler even refused to allow Turner into the room. 

Last year, after the Faculty Senate voted overwhelmingly to endorse an investigation into psychiatric research misconduct at the University, Kaler said that he would permit the investigation but that investigation would not cover the time during which Dan Markingson committed suicide.

This response is astonishing. Like a child with his fingers in his ears, Kaler apparently believes that if he does not hear any credible reports of research abuse, they did not occur.

Gjere told KMSP-TV that a “culture of fear” prevents hospital employees from speaking out about the mistreatment of patients. Asked what her greatest concern was, Gjere said, “That it continues to happen. That patients are continuing to be harmed, that nothing’s been fixed.”

It is time for the state Legislature to step in and finally give these troubling issues a public hearing.

Legislators need to ask themselves a question.

Who should they believe: The nurse on the ward who is blowing the whistle or the man with his fingers in his ears?



No comments:

Post a Comment