The Death of David Markingson and Accounts of Corruption in the CAFE Clinical Trials
Over ten years have passed since the death of David Markingson during the CAFE clinical trial funded by AstraZeneca, but attention remains on the case as old questions go unanswered and new questions continue to arise.
From claims trial coordinators withholding information to allegations of data manipulation and botched investigations, the case has become an alarming example of just how easily ethics may be overshadowed by the economics of a clinical trial. All information below from an investigastive peice published in Mother Jones in 2010.
David Markingson and the CAFE Clinical Trial
- David Markingson, a man in his mid- 20s, was diagnosed with schizophrenia in 2003 and was put on Risperdal in order to treat the diagnosis.
- After a particularly violent epsiode, he was involuntarily committed to a state mental institution.
- According to the Mother Jones article, his treating psychiatrist, Dr. Stephen C. Olson, an associate professor at the University of Minnesota Academic Health Center, offered him a chance to avoid involuntary commitment by participating in a study funded by AstraZeneca, the Comparison of Atypicals in First Episode (CAFE) clinical trial.
- Though the doctor had signed a court petition which stated Mr. Markingson was incapable of consenting to medication, he did allow Mr. Markingson to sign consent forms for the clinical trial.
- The clinical trial was to compare the effectiveness of three FDA approved ‘atypical’ antipsychotics: Seroquel (AstraZeneca) Risperdal (Janssen Pharmaceuticals) and Zyprexa (Eli Lilly).
- As part of the study, participants were subject to two dangerous guidelines:
- Patients were barred from being taken off their randomly assigned medication.
- Patients were restricted in the number of additional drugs that could be given to manage side effects including depression, anxiety, and agitation.
The Death of David Markingson during the CAFE Clinical Trial
- During the trial, Markingson's mother reportedly noted disturbing changes in her son.
- Though she reported her concerns to both Dr. Olson and those conducting the clinical trial, her concerns were not addressed and the experiment continued with no further consideration.
- A social worker at the halfway house to which Mr. Markingson was transferred also expressed written concerns about his behavior and appearance. Still, no changes were made to Mr. Markingson’s medication and he was to continue his role in the clinical trial.
- Shortly after, Mr. Markingson was found dead in a bath tub at the halfway house. According to the report, he stabbed himself with a box cutter and nearly nearly decapitated himself.
Victim's Mother Sues, Dr. Olson found to be Linked to AstraZeneca
- In January of 2005, the FDA began to investigate the death of Mr. Markingson, but did not find any violation of protocol or evidence of misconduct according to their investigation report.
- Ms. Weiss sued the University of Minnesota, AstraZeneca, Dr. Olson and his co-inspector Dr. Schulz for her son's death and the events leading up to it including the signing of the consent forms.
- The case was dismissed with a partial summary judgment. For the death of her son, Ms. Weiss was paid a settlement of $75,000 in the suit against Dr. Olson for his allowing Mr. Markingson to sign the clinical trial consent forms.
- The case did, however, reveal the following:
- The psychiatry department at the University of Minnesota received $15,648 for each subject that completed the clinical trial. That became a total of $327,000.
- Dr. Olson, according to a court deposition exhibit, was a consultant for AstraZeneca and recieved payents from the company. He was also a member of the “speaker’s bureaus” of a number of other pharmaceutical companies.
- Dr. Olson had personally received $240,045 from big pharmaceutical companies between 2002 and 2008, $149,344 of which came from AstraZeneca.
- According to the Mother Jones article, Dr. Charles Schulz, Dr. Olson’s co-investigator on the CAFE clinical trials, received $571,000 from big pharmaceutical companies with $112,020 coming from AstraZeneca.
- In 2010, the New York Times reported that AstraZeneca paid $520 million to settle a case involving the off label marketing and illegal marketing claims made in regards to Seroquel.
- Despite all this, the University of Minnesota is currently demanding that Mary Weiss pay $57,000 to cover the trials legal expenses.
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