XPost: alt.society.mental-health, alt.psychology.personality   
   From: pjbrass@uswest.net   
      
   St. Paul Pioneer Press (Minnesota)   
   The death of Subject 13   
   By Jeremy Olson and Paul Tosto Pioneer Press   
   May 18, 2008   
      
   Subject 13 was dead.   
   Enrolled in a clinical trial testing the effects of anti-psychotic   
   drugs at the University of Minnesota, the schizophrenic had killed   
   himself May 8, 2004, in a grisly suicide.   
      
   Tragic, a U official wrote in a "serious adverse event" memo to the   
   U.S. Food and Drug Administration, but suicide was "unfortunately not   
   uncommon in this study population."   
      
   Unfortunate, but not unpredicted. Subject 13 had a mother who thought   
   that her son, Dan Markingson, wasn't getting better during his six   
   months in the study. Mary Weiss sent five letters and made numerous   
   calls to the researchers, complaining that her son, the 13th enrollee,   
   didn't have the wherewithal to consent to the study and requesting   
   that he be withdrawn.   
      
      
   St. Paul, Minnesota   
   The university disregarded her letters and calls. She later filed a   
   lawsuit, accusing Markingson's psychiatrist and the study's director,   
   Dr. Stephen Olson, of coercing him to sign up. The lawsuit claimed the   
   university kept Markingson enrolled to preserve its research and to   
   keep payments coming for his participation.   
      
   "Do we have to wait until he kills himself or someone else," she asked   
   three weeks before the suicide, "before anyone does anything?"   
      
   The death prompted reviews by the state mental health ombudsman and   
   the U.S. Food and Drug Administration about the conduct of the   
   university and Olson, who was Markingson's only psychiatrist at the   
   time he recruited him into the study. The reviews and the lawsuit   
   probed whether Markingson was coerced into the study by the threat of   
   commitment to a psychiatric hospital and whether the university   
   provides adequate protection of mentally ill research subjects. The   
   lawsuit also revealed the pressure to recruit research subjects.   
      
   Neither Olson nor the U has been blamed by any oversight agency for   
   the death, or cited for research violations. The U was dismissed from   
   the lawsuit in February, and Olson settled in April. Four years after   
   Markingson's death, the university has moved on. Weiss has not. She   
   endures the pain of a mother who says she couldn't get anyone to   
   listen.He fit the profile   
      
   Markingson was a celebrity-tour bus driver in Los Angeles in summer   
   2003 when his mother, from South St. Paul, arrived for a visit. Weiss   
   found a 26-year-old who believed that aliens had burned a spot on his   
   carpet and that a secretive world order would call on him to kill   
   people in a "storm."   
      
   Desperate to get her only son back home, Weiss sent him e-mails   
   pretending to be the "guardian angel" spirit of Markingson's dead   
   grandmother and suggesting the storm would start in Minnesota.   
      
   The deception worked, but the return home didn't seem to change   
   Markingson's mental state. He started having visions of killing his   
   mother in the storm. Markingson was taken Nov. 12, 2003, to Regions   
   Hospital in St. Paul, but it had no open psychiatric beds. He was then   
   transferred to the University of Minnesota Medical Center, Fairview.   
      
   Weiss said discussions about research started right away at the   
   hospital. Markingson was placed in Fairview's Station 12, a new unit   
   at the time created to treat psychotic patients and screen them for   
   research. Olson and Dr. Charles Schulz, head of the U's psychiatry   
   department, helped launch the unit in part to enhance the hospital's   
   startup schizophrenia program and meet the U's mandate to bring in   
   more research dollars.   
      
   Olson first recommended on Nov. 14 that a Dakota County District Court   
   commit Markingson to the state treatment center in Anoka because he   
   was not fit to make decisions about his care. He wrote to the court   
   that Markingson was convinced his delusions were real and that he   
   wasn't mentally ill.   
      
   The doctor changed his opinion about the commitment in less than a   
   week, telling the court Markingson had started to acknowledge the need   
   for help.   
      
   Reversals by patients are common, Olson explained in an interview with   
   the Pioneer Press last month. Schizophrenics often arrive for   
   treatment with delusions and denial but change their outlook while   
   hospitalized.   
      
   A judge agreed Nov. 20 with Olson's new recommendation, requiring   
   Markingson to follow the doctor's treatment plan. The next day,   
   Markingson signed a consent form to be part of a national   
   anti-psychotic drug study, Comparison of Atypicals for First Episode,   
   or CAFE.   
      
   Weiss didn't understand. How could her son be deemed incapable of   
   making decisions one day and then consent to a drug study the next?   
      
   The study, funded by drugmaker AstraZeneca and spread among 26   
   institutions, compared the effectiveness of three commonly used   
   anti-psychotic drugs -- Seroquel, Zyprexa and Risperdal.   
      
   Olson had been searching for recruits for more than a year. The study   
   required a very specific and elusive person -- a schizophrenic   
   experiencing his first symptoms. Markingson fit that profile.   
      
   Weiss wasn't expecting a schizophrenia diagnosis. At Regions, her son   
   responded well to a medication for bipolar disorder. The family has a   
   history of that disorder as well.Question of bias   
      
   Full participation required Markingson to take one anti-psychotic drug   
   for up to a year and to appear at the U for checkups. Markingson   
   received AstraZeneca's Seroquel. As Subject 13, Markingson was worth   
   $15,000 to the U, with some of that going to Olson's salary and the   
   psychiatry department. Switching or adding medications could have   
   disqualified Markingson and halted payments to Olson and the   
   department from AstraZeneca.   
      
   Overall, the study offered $327,000 to the U and an opportunity to   
   raise the profile of its schizophrenia program.   
      
   Weiss' lawsuit claimed that this money gave Olson a conflict of   
   interest regarding Markingson's care.   
      
   Four experts hired by Weiss' attorneys agreed that Olson had an   
   ethically questionable position -- as the gatekeeper over Markingson's   
   commitment, as his treating psychiatrist, and as the researcher with a   
   financial incentive to enroll patients.   
      
   "For a physician to exercise such medical, research and legal power   
   and control over a research subject is an extraordinary, if not   
   unprecedented, example of unethical coercive practices," said Dr.   
   Keith Horton, a Minneapolis psychiatrist who gave a written opinion in   
   Weiss' suit.   
      
   The university's own Web-based guidance on research ethics advises   
   recruiting "in a non-biased, non-power-based manner" and states that   
   "doctor-patient relationships between the investigator and   
   participants should be avoided, when possible, to eliminate any   
   power-based coercion."   
      
   In a recent interview, Olson said that it is difficult for an academic   
   physician to avoid this conflict and that in this case the conflict   
   didn't matter. As Olson's patient, Markingson was going to receive one   
      
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