June  5,  2013     Eric  Kaler,  PhD   President,  University  of  Minnesota   202  Morrill  Hall   100  Church  Street

 S.E.   University  of  Minnesota   Minneapolis,  MN   55455     Dear  President  Kaler:     Thank  you  for  your  letter  of  May  29,  2013.  While  I  appreciate  receiving  your  response  to  my   letter,  the  substance  of  your  message  is  inaccurate  and  unconvincing.  When  asked  to  initiate  an   investigation  into  the  death  of  Dan  Markingson  and  the  clinical  study  in  which  he  was  enrolled,   the  standard  response  from  senior  officials  at  the  University  of  Minnesota  is  to  claim  that  no   additional  review  is  required  because  Markingson’s  death  has  already  been  thoroughly   investigated  by  the  Office  of  General  Counsel,  University  of  Minnesota  IRB,  FDA,  Hennepin  County   District  Court,  Minnesota  Board  of  Medical  Practice,  and  the  Office  of  the  Minnesota  Attorney   General.  Your  response  echoes  several  of  these  familiar  talking  points  even  though  they  have  all   been  discredited.  My  previous  letter  to  you  provides  a  brief  summary  of  why  there  needs  to  be  an   independent,  impartial  investigation  of  Dan  Markingson’s  death,  the  CAFÉ  study,  and  possible   psychiatric  research  misconduct  at  the  University  of  Minnesota.  Here,  I  limit  myself  to  rebutting   the  claims  you  make  in  your  letter.         You  mention  that  the  death  of  Dan  Markingson  has  “been  the  subject  of  proceedings”  before  the   University  of  Minnesota’s  Office  of  General  Counsel.  The  Office  of  General  Counsel  is  not  an   impartial  investigative  body.  To  the  contrary,  the  mandate  of  the  Office  of  General  Counsel  is  to   “zealously  represent”  the  University  of  Minnesota.  In  the  lawsuit  brought  against  the  university   by  Dan  Markingson’s  mother,  Mary  Weiss,  the  Office  of  the  General  Counsel  defended  the   University  of  Minnesota.  The  University  of  Minnesota’s  Office  of  General  Counsel  advocates  for,   defends,  and  advances  the  interests  of  the  University  of  Minnesota.  It  is  not  a  suitable  internal   body  for  impartially  investigating  complaints  that  faculty  members  have  engaged  in  research   misconduct.  Mark  Rotenberg,  the  university’s  former  General  Counsel,  should  never  have  been   allowed  to  serve  as  the  University’s  legal  counsel,  in-­‐house  “investigator”,  and  de  facto  public   spokesperson  deployed  to  rebuff  calls  for  an  independent  inquiry  into  Dan  Markingson’s  death.   The  University  of  Minnesota  must  stop  misusing  the  Office  of  General  Counsel  in  this  manner.      

2 It  is  true  that  Dan  Markingson’s  case  was  the  subject  of  legal  proceedings  before  the  Hennepin   Country  District  Court.  What  your  letter  fails  to  acknowledge  is  that  in  this  wrongful  death   lawsuit  the  University  of  Minnesota  won  summary  judgment  on  the  basis  that  it  is  statutorily   immune  from  liability.  As  you  must  know,  to  be  deemed  statutorily  immune  from  liability  is  not  a   vindication  of  conduct.  On  the  contrary,  it  simply  means  that  the  University  of  Minnesota  did  not   have  to  defend  itself  against  the  lawsuit  brought  by  Ms.  Weiss.  Such  an  outcome  should  never  be   portrayed  as  an  exoneration  of  the  University  of  Minnesota.               The  Minnesota  Board  of  Medical  Practice  responded  to  complaints  about  Dr.  Stephen  Olson  and   Dr.  Charles  Schulz.  Unfortunately,  your  letter  omits  several  key  points.  The  medical  licensing   board  does  not  investigate  universities  and  institutional  review  boards.  There  is  therefore  no   meaningful  basis  for  suggesting  that  the  Minnesota  Board  of  Medical  Practice  investigated  the   University  of  Minnesota.  The  Minnesota  Board  of  Medical  Practice  issued  form  letters  stating  that   “the  facts  of  the  case  did  not  provide  a  sufficient  basis  for  the  Board  to  take  disciplinary  or   corrective  action”  in  response  to  the  filed  complaints.  However,  there  is  no  public  record  of  the   Board’s  deliberations,  the  scope  of  its  investigation  and  the  issues  it  addressed,  the  evidence  it   gathered,  and  the  reasoning  that  informed  its  conclusions.  What  is  a  matter  of  public  record  is   that  the  Minnesota  Board  of  Medical  Practice  does  not  investigate  universities,  institutional   review  boards,  and  institutional  research  governance  structures.       With  regard  to  the  FDA,  the  Establishment  Inspection  Report  issued  by  the  FDA  failed  to   acknowledge  the  numerous  reports  documenting  that  Dan  Markingson  was  psychotic  and  lacked   the  capacity  to  make  his  own  medical  decisions.  As  my  May  13  letter  to  you  notes,  on  at  least   three  occasions  shortly  before  Markingson  was  enrolled  in  the  CAFÉ  study  he  was  judged  to  lack   decision-­‐making  capacity.  In  addition,  the  person  who  enrolled  him  in  the  study  was  unqualified   to  assess  decision-­‐making  capacity  of  prospective  research  participants,  under  considerable   pressure  to  recruit  study  participants,  and,  as  the  clinical  trial  coordinator  for  the  trial,  had  a   serious  conflict-­‐of-­‐interest.  An  independent  investigation  of  Dan  Markingson’s  death  and  the   study  in  which  he  was  enrolled  must  examine  how  and  why  Markingson  was  “consented”  into  a   clinical  study  when  he  was  diagnosed  as  psychotic,  lacked  insight  into  his  disease  and  mental   state,  and  was  deemed  unable  to  make  informed  decisions  about  administration  of  antipsychotic   drugs.  The  FDA  Inspection  Report  fails  to  address  the  paper  trail  documenting  the  various   occasions  Markingson  was  deemed  mentally  incompetent  to  make  his  own  medical  decisions.  The   FDA  Inspection  Report  also  fails  to  note  that  Markingson  was  enrolled  in  the  CAFÉ  study  despite   his  mother’s  repeated  objections.  It  is  possible  that  this  significant  flaw  in  the  FDA’s  inspection   report  is  connected  to  the  FDA  investigator’s  failure  to  interview  Dan  Markingson’s  mother,  Mary   Weiss,  and  ensure  that  her  voice  was  taken  into  consideration.     I  must  draw  to  your  attention  two  important  omissions  in  your  letter.       First,  in  2009,  the  Minnesota  State  Legislature  passed  a  law  that  restricts  individuals  under  civil   commitment  orders  from  being  enrolled  in  psychiatric  drug  studies.  This  statute,  as  I’m  sure  you   know,  is  commonly  referred  to  as  “Dan’s  Law.”  I  encourage  you  to  reflect  upon  why  it  was   necessary  for  the  Minnesota  State  Legislature  to  pass  this  law.    

3 Second,  your  letter  fails  to  mention  the  Corrective  Action  that  the  Minnesota  Board  of  Social  Work   issued  to  the  study  coordinator  for  the  CAFÉ  trial.  According  to  this  document,  Jeanne  Kenney,  the   trial  coordinator,  “regularly  completed  forms,  gathered  information,  and  performed  tasks  that   were  beyond  Licensee’s  competence  and  scope  of  practice  as  a  clinical  social  worker.”  Kenney   also  made  numerous  documentation  errors,  dispensed  prescription  drugs  without  authorization   and  in  violation  of  University  of  Minnesota  policy,  initialed  documents  with  a  doctor’s  initials,   failed  to  respond  to  family  concerns  in  a  timely  and  effective  manner,  failed  to  document  key   information  related  to  medical  interventions  and  treatment  plans,  prepared  documentation  that   “consistently  fell  below  the  minimum  standards  of  practice  for  a  clinical  social  worker,”  failed  to   develop  a  “clearly  articulated,  consistent  set  of  treatment  goals,”  failed  to  document  in  a  timely   manner    “alarming  voicemail  messages  from  family  members,”  and  “effectively  invalidated”  Dan   Markingson’s  original  informed  consent  by  failing  to  disclose  to  him  new  information  concerning   risk  of  hyperglycemia  and  diabetes.  Of  particular  significance,  the  Board  of  Social  Work  found  that   “there  were  critical  omissions  in  Licensee’s  documentation  that  were  relevant  to  suicide   prevention  and  chemical  dependency  treatment.”  Given  the  findings  of  the  Minnesota  Board  of   Social  Work,  it  is  noteworthy  that  you  and  other  senior  administrators  at  the  University  of   Minnesota  fail  to  mention  this  document  when  you  list  prior  investigations  of  Dan  Markingson’s   death.  The  Corrective  Action  issued  to  Jeanne  Kenney  reveals  the  need  for  an  investigation  that   examines  all  layers  of  oversight  and  includes  analysis  of  the  faculty  members  responsible  for   supervising  the  clinical  trial  coordinator  and  conducting  the  study.               There  is  an  urgent  need  for  an  independent  and  impartial  investigation  of  Dan  Markingson’s   death,  the  study  in  which  he  was  enrolled,  and  possible  psychiatric  research  misconduct  at  the   University  of  Minnesota.  Carl  Elliott,  my  colleague  here  at  the  Center  for  Bioethics,  makes  an   exhaustive  case  for  such  an  investigation.  Senior  officials  at  the  University  of  Minnesota  claim  that   Markingson’s  death  was  fully  reviewed.  However,  an  independent,  thorough  investigation  has  not   occurred.  I  therefore  ask  you  to  reconsider  your  decision,  sign  the  petition  initiated  by  Mary   Weiss  and  Mike  Howard,  and  write  to  Governor  Dayton  and  request  an  independent  investigation   of  possible  psychiatric  research  misconduct  at  the  University  of  Minnesota.  Whatever  you  decide,   I  want  my  correspondence  with  you  to  document  that  in  the  strongest  possible  terms  I  urged  you   to  support  such  an  investigation.       Yours  sincerely,             Leigh  Turner,  PhD   Associate  Professor   University  of  Minnesota  Center  for  Bioethics   N520  Boynton,  410  Church  Street  SE   Minneapolis,  Minnesota,  55455   Phone:  612.626.4830   Email:  turne462@umn.edu  

Sign up to vote on this title
UsefulNot useful