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.

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