Tuesday, November 13, 2012

 Would you be interested in having your son

 participate in a clinical trial run by these folks?

"Corrective Action" in Markingson Trial

Dan Markingson committed suicide after his participation in the drug trial. 

A state board has issued “corrective action” against the University of Minnesota study coordinator in a 2003 research trial that led to the suicide of participant Dan Markingson.

The report is the first official action to allege any wrongdoing since the suicide, which bioethicists have said may  have been a result of ethical lapses. They still say the corrective actions are not enough.

The Minnesota Board of Social Work said Jean Kenney made repeated errors in documentation, performed tasks beyond her expertise and didn’t adequately address family concerns over the treatment of Markingson, who committed suicide during the study.

Critics say Markingson was coerced into the study and that he didn’t give completely informed consent.
Markingson was involuntarily committed to the University of Minnesota Medical Center, Fairview psychiatric ward in 2003. He was then entered into a University of Minnesota anti-psychotic drug research trial funded by AstraZeneca.

Six months after joining the study, he stabbed himself to death. He was 26.

Mike Howard, a close friend to Markingson’s mother, Mary Weiss, filed the initial complaint against Kenney in early 2009 with the Minnesota Board of Social Work.

The board hired an independent investigator to look into the complaints, Howard said.

“It’s a hard document to make sense of,” said University bioethics professor Carl Elliott. “On one hand it outlines a fair amount of wrongdoing, but on the other hand there’s no punishment of any significance for Kenney. The really serious wrongdoing in the Markingson case isn’t really addressed in [the report].”
Howard added that the report may be the end of Kenney’s involvement with the case but that he anticipates further action regarding others involved.

“I think [Kenney] was a pawn,” Howard said. “She did what she was told.”

Kenney’s job was to recruit patients for the study, called “Comparison of Atypicals for First-Episode of Psychosis,” as well as to collect data from those enrolled.

The board found that Kenney routinely performed tasks beyond her level of expertise and competence. She made numerous errors in notes, like writing “hyperthyroidism” instead of “hypothyroidism” and listing the wrong dosage of Markingson’s medication.

Once Kenney made an error, it would be repeated throughout the study.

The board also says Kenney went back to the records after Markingson’s suicide to fix some of her errors.
David Alsop, who represented Kenney, said “some of her documentation was not the best” but denied that those errors affected Markingson’s care or caused his suicide.

Alsop said Kenney doesn’t want to comment directly to the media.

As demanded by the board, Kenney will complete 18 hours of continuing education and three hours of consultation and write up a report on what she learned for the board.

If Kenney completes the assigned tasks, the board will close the investigation.

“There’s no more action,” Alsop said. “This is the end of it.”

The board also found problems with the CAFÉ study as a whole.

“Despite the large amount of data gathered” in the study, there did not seem to be an analysis of the data, including in the treatment planning process, according to the document.

The record also links the problems to Markingson’s suicide.

“There were critical omissions in [Kenney’s] documentation that were relevant to suicide prevention” the board investigation found.

Years-long controversy

The corrective action comes after years of calls for further investigation into the ethics behind the study. But multiple internal and external investigations found no wrongdoing by the University, and it has defended those involved in the study since the start.

In late 2010, eight University professors sent a letter to the Board of Regents seeking external review of what they said was “an alarming series of ethical violations and lapses” leading to Markingson’s death

Regents denied the request, citing investigations by the University’s Institutional Review Board, the Food and Drug Administration and the Minnesota Board of Medical Practice that all found no evidence of misconduct.
Elliott was one of the professors in the letter.

“The University of Minnesota Department of Psychiatry was complicit in manipulating research results for AstraZeneca, and it looks very likely that the CAFÉ study was part of that manipulation,” Elliott said.
Vice President for Health Sciences Aaron Friedman, defended the University’s involvement with research funded by industry, saying in a letter to Academic Health Center employees, “it’s our job to ensure that knowledge becomes widely available,” according to a 2011 email.

In a statement responding to the board’s corrective action, University General Counsel Mark Rotenberg said Kenney is no longer an employee at the University. He referenced the investigations that found no wrongdoing on behalf of the University
“Most importantly, none found any causal link between the CAFÉ trial and the death of Mr. Markingson,” he said.

Howard said the University is in denial.

“That’s how the U does things,” he said. “It’s deny, deny, deny.”

The report is “the first part of recovering” for those who were close to Markingson, Howard said.

In the weeks leading up to Markingson’s suicide, his mother wrote letters to Charles Schulz, head of the University’s Department of Psychiatry. She expressed concern with her son’s involvement in the CAFÉ studies and the care he received from psychiatrist Stephen Olson, who also was a co-investigator in the study. She asked if Schulz would feel comfortable if his own son were in Markingson’s position.

In his response, Schulz wrote, “I would be very interested in my son receiving treatment in a well organized treatment trial that has been run by such effective staff as Dr. Olson and Jeannie Kenney.”

Given what follows, I would never let my son, or anyone else for that matter, have anything to do with a study conducted by these people.

From the Board of Social Work's Report:


 2. For the purposes oft his Agreement, the corrective action warranted herein is based on the following.

a. Beginning in June 2002, Licensee worked as a study coordinator./psychiatric social worker for the department of Psychiatry at the University of Minnesota. Licensee's duties included recruiting patients for the CAFE study, a double blind comparison of three medications used in treating first episode psychosis. Licensee was also responsible for collecting data from the study participants.

b. In December 2003, client #1, a twenty-seven year old adult male, was discharged from Fairview Hospital after an involuntary commitment.

c. Between December 2003 and May 2004 Licensee provided clinical social work services to client #1 while he participated in the CAFE study. 

d. Although Licensee had no formal medical training or experience with respect to obtaining medical histories or handling adverse drug events, Licensee regularly completed forms, gathered information, and performed tasks that were beyond Licensee's competence and scope of practice as a clinical social worker. Licensee also made numerous documentation errors in performance of these tasks. Examples include the following:

1) On November 24, 2003, Licensee completed a medical history that called for evaluation of body systems for past or active medical disorders. The form listed 22 categories including otolaryngological (ear, nose, and throat), cardiovascular, gastrointestinal, renal, dermatologic, and hematologic disorders.  On the medical hisotry form, Licensee incorrectly listed client #1's diagnosis as hyperthyroidism rather than hypothyroidism.  This incorrect medical diagnosis was repeated throughout client #1's medical record.

2) On the medication log, Licensee correctly listed client #1's Synthroid dose as 25 micrograms for client #1's baseline visit. However, beginning with visits 3 through 10 as 25 milligrams, a significant quantity error. The medication log also contained the incorrect diagnosis of hyperthyroidism.

3) On nine occasions, beginning on December 5, 2003, Licensee completed the Adverse Event/Medical Diagnosis form which called for a "clinicial rating of severity" for orthostatic faintness, dry mouth, constipation, sialorrhea, gynomastia, galactorrhea, sex drive, sexual arousal, sexual orgasm, incontinence, nocturia, urinary hesitancy, skin rash, hypersomnia, weight gain, akathisia, and akinesia. On two additional occasions, Licensee delegated the task of completing this form to a social work intern, who Licensee was supervising. 

4) Between November 24, 2003, and April 28, 2004, Licensee completed forms assessing the Barnes Rating Scale for drug-induced aksthisia, as well as weight, vital signs and waist, hip, height measurements. Licensee also completed the Simpson-Angus Abbreviated Examination of gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity and tremor. 

5) Licensee dispensed legend prescription drugs without authorization and in violation of the University's policy. 

e) Licensee routinely initialed clinical documents with a physician's initials when the physician neglected to do so. 

f) Licensee failed to adequately address family concerns in a timely and effective manner, failed to document critical information regarding intervention and plans, and failed to maintain sufficient inter-agency communications.

g) Licensee's documentation consistently fell below minimum standards of practice for a clinical social worker. Examples include the following:

1). Despite the large amount of data gathered as part of the CAFE study, the records are devoid of any evidence that the data was critically analyzed or used in the treatment planning process.

2) The records are devoid of any clearly articulated, consistent set of treatment plans or goals, or plans that demonstrate measurement of progress or reasonably allow for continuity of care.

3) Relevant notes were not entered into client #1's medical record in a timely manner, even when in response to alarming voice mail messages from family members.

4) There were critical omissions in Licensee's documentation that were relevant to suicide prevention and chemical dependency treatment. 

h) On March 17, 2004, Licensee received an email message from the CAFE study sponsor warning of a new risk of hyperglycemia and diabetes for patients taking medications used in the CAFE study. This new information effectively invalidated client #1's original informed consent. 

i) As client #1's primary contact, it was Licensee's obligation to communicate the new risk information to client #1 and the informed consent form should have been modified and resubmitted to the Institutional Review Board. There is no documentation that Licensee discussed the new informed consent with client #1 or took any other action.

j. On May 8, 2004, client #1 committed suicide.

k. On May 11, 2004, on the Serious Adverse Event Report, completed after client #1's death, Licnesee again incorrectly listed the diagnosis of hyperthyroidism and incorrectly listed the Synthroid dose

l. On or about July 24, 2004, Licensee went through client #1's medical records and made hanwritten revisions, changing hyperthyroidism to the correct diagnosis of hypothyroidism. Licensee initialed and dated the revisions.


3. The Board views Licensee's conduct in paragraph 2 as a violation of Minnesota Statutes section 148 and the rules of the Board pursuant to section 148.


And The Angels Wept....

Some background:

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

 From the Star-Tribune:

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.

Friday, November 2, 2012

University of Minnesota eliminates Office of Academic Administration; move saves $1.6 million

Simply amazing...

See previous posts:


The University of Minnesota is taking what it called its most decisive step yet to shrink administrative expenses.

The university is eliminating its Office of Academic Administration to coincide with the departure of Robert Jones, the vice president in charge of that office.

The U estimates shutting that office and divvying up its roles among other departments will save about $1.6 million. Of the savings, Jones' salary and benefits account for $414,300. 

 "Because Robert has done such a good job, we're now in a place where we don't need the convenient function his office provided," said Amy Phenix, Kaler's chief of staff.

Former Regent Steve Sviggum, state legislators and others have questioned whether the U is too top-heavy, an assertion Kaler has disputed. They have urged the university to find ways to operate more efficiently. In the biennial funding request the U is pitching to legislators, it vows to trim $28 million in administrative spending over two years. 

Michael McNabb, a member of the U's alumni association and outspoken critic of its administrative costs, said the move is a step in the right direction, but the university should do more: "The excessive cost of administration is one factor for the skyrocketing tuition over the past decade that has imposed financial hardship on students and their parents."