Saturday, March 21, 2015

Numerous news reports on the Scandal of the Death of Dan Markingson

A list of resources related to the death of Dan Markingson who was a psychiatric research subject who died during an experiment.

  1. "Student dies at Rochester in MIT-based study,” Massachusetts Institute of Technology News Release, April 10, 1994.
  2. In the Matter of the Civil Commitment of Daniel Markingson, State of Minnesota, County of Dakota, Court File PX-03-10465, November 17, 2003.
  3. House Research Bill Summary, File Number H.F. 3553, Authors: Pugh, Whelan, and Bernardy; Subject: Clinical drug trials; oversight, Analyst: Lynn Aves, April 4, 2016.
  4. Aftercare agreement for Dan Markingson, December 8, 2003.
  5. "The Academic Health Center Responds to Carl Elliott’s Media Outreach," September 1, 2010.
  6. “Once-Secret Drug-Company Records put U on the Spot,” Star Tribune (Minneapolis), March 19, 2009.
  7. In the Matter of the Civil Commitment of Dan Markingson, Respondent, State of Minnesota, County of Dakota, File No. PX-O3-10465, November 20, 2003.
  8. Aaron Friedman, “University of Minnesota research case is not a scandal,” Star Tribune (Minneapolis), May 16, 2013.
  9. Alex Friedrich, “U's handling of drug study suicide earns an 'F' among peers,” Minnesota Public Radio News, April 23, 2015.
  10. Alexandros Stamatoglou, “The Physician Payment Sunshine Act: An Important First Step in Mitigating Financial Conflicts of Interest in Medical and Clinical Practice,” 45 John Marshall Law Review 2012, pp. 963-990.
  11. Alicia Mundy, “Sting Operation Exposes Gaps in Oversight of Human Experiments,” Wall Street Journal, March 26, 2009.
  12. Andy Mannix, “Charles Schulz under Scrutiny for Seroquel Study Suicide,” City Pages, February 2, 2011.
  13. Andy Mannix, “Dan Markingson's 2004 suicide: 'Corrective Action' issued to former U of M employee,” City Pages, November 13, 2012.
  14. Arne Carlson,“Markingson case: University of Minnesota can't regain trust under current leadership,” Star Tribune (Minneapolis), April 13, 2015.
  15. Association for the Accreditation of Human Research Protection Programs. An External Review of the Protection of Human Research Participants at the University of Minnesota with Special Attention to Research with Adults Who May Lack Decision-making Capacity, February 23, 2015.
  16. Board of Regents of the University of Minnesota and Institutional Review Board, Notice of Taxation of Costs and Bill of Costs and Disbursements, State of Minnesota, County of Hennepin, Court File 27 CV-07-1679, April 29, 2008.
  17. C. Fred Alford, Whistleblowers: Broken Lives and Organizational Power (Cornell University Press, 2002).
  18. C.M Michael, S.J, Nass, G.S. Omenn (eds), Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials; Board on Health Care Services; Board on Health Sciences Policy; Institute of Medicine; Evolution of Translational Omics: Lessons Learned and the Path Forward, Washington (DC): National Academies Press (US); 2012.
  19. Carl Elliott, "The Deadly Corruption of Clinical Trials." Mother Jones, September/October 2010, 54-63.
  20. Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.
  21. Carl Elliott, "Getting by with a Little Help from Your Friends." Hastings Center Bioethics Forum, October 18, 2013.
  22. Carl Elliott, “The Best-Selling, Billion-Dollar Pills Tested on Homeless People,” Matter, July 27, 2014.
  23. Carl Elliott, Matt Lamkin, “Restrict the Recruitment of Involuntarily Committed Patients for Psychiatric Research, JAMA Psychiatry 2016; April 1; 73(4):317-8.
  24. Charlotte Haug, “What Happened to Dan Markingson?” Journal of the Norwegian Medical Association, 133, pp. 2443-2444.
  25. Chris Hansen, “The Hansen Files: Drug Trials,” Dateline NBC, March 4, 2012.
  26. Clinical Research and Compliance Consulting, "University of Minnesota Department of Psychiatry Assessment Report," December 31, 2015.
  27. David Evans, Michael Smith, and Liz Willen, “Big Pharma's Shameful Secret,” Bloomberg Markets 14 (2005): 36–62.
  28. Debra Dykhuis, Human Research Protection Program, letter to Robert Huber, May 6, 2015.
  29. Debra Dykhuis, Human Research Protection Program, letter to Carl Elliott, June 5, 2015.
  30. Duff Wilson, “For $520 Million, AstraZeneca Settles Case Over Marketing of a Drug,” New York Times, April 27, 2010.
  31. Eden Almasude, “A Medical Student’s Call for Action Against Research Misconduct,” Bioethics Forum, June 3, 2014.
  32. Emily Kaiser and Tom Webber, “Arne Carlson: U needs leadership overhaul after Markingson case,” Minnesota Public Radio News, April 13, 2015.
  33. Ezekiel J Emanuel, Trudo Lemmens, Carl Elliott, “Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?” PLoS Medicine, July 25, 2006.
  34. Gardiner Harris, “Report Assails F.D.A. Oversight of Clinical Trials,” New York Times, September 28, 2007.
  35. Gina Kolata, “Johns Hopkins Admits Fault in Fatal Experiment,” New York Times, July 17, 2001.
  36. J. Jacobson, Report of Examiner. Dakota County Court File No. PX-03-10. November 19, 2003.
  37. J.P. McEvoy, J.A. Lieberman, et al. "Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison, American Journal of Psychiatry. 2007 July; 164(7):1050-60.
  38. Jeanne Lenzer, “Drug Secrets: What the FDA Isn’t Telling,” Slate.com, September 27, 2005.
  39. Jeff Baillon, “Nurse questions integrity of U of M drug researchers,” Fox 9 News (KMSP), May 19, 2014.
  40. Jeff Baillon, “Nurse questions integrity of U of M drug researchers," Fox 9 News, KMSP, November 25, 2014.
  41. Jeff Baillon, "U of M Drug Study Criticism Grows." Fox 9 News. KMSP. May 19, 2014.
  42. Jeff Baillon, “Another Ethics scandal for the University of Minnesota Department of Psychiatry,” Fox 9 News, KMSP, July 15, 2014.
  43. Jennifer Couzin-Frankel, “A Lonely Crusade,” Science, May 23, 2014;344(6186):793-7
  44. Jennifer Couzin-Frankel, “Human subjects protections under fire at the University of Minnesota,” ScienceInsider, March 2, 2015.
  45. Jeremy Olson, “Review finds lapses at University of Minnesota psychiatry department,” Star Tribune (Minneapolis), February 11, 2016.
  46. Jeremy Olson, “Auditor to review U's drug trial suicide,” Star Tribune (Minneapolis), June 19, 2014.
  47. Jeremy Olson, “U psychiatry chief steps down in wake of research criticism,” Star Tribune (Minneapolis), April 13, 2015.
  48. Jeremy Olson, “Minnesota House, Senate Unanimously Pass Limits on Researchers’ Use of Mentally Ill Patients,” Pioneer Press (St. Paul), May 8, 2009.
  49. Jo Zillhardt, Office of the Ombudsman for Mental Health and Mental Retardation, Medical Review Subcommittee, letter on death of Dan Markingson, June 17, 2005.
  50. Jo Zillhardt, Office of the Ombudsman for Mental Health and Mental Retardation, Medical Review Subcommittee, letter on death of Dan Markingson, June 17, 2005.
  51. Judy Stone, “A Clinical Trial and Suicide Leave Many Questions: Part 6: The Run-Around, or Why I Now Call for an Independent Investigation of University of Minnesota,” Scientific American Molecules to Medicine blog, March 26, 2013.
  52. K. Geister, Report of Pre-petition Screening Team Re: Daniel Markingson, Respondent. November 17, 2003.
  53. Katie Thomas, “A Drug Trial’s Frayed Promise,” New York Times, April 17, 2015.
  54. Kia Farhang and Marion Renault, “Faculty push for independent research review," Minnesota Daily, December 09, 2013.
  55. Laura Stark, Behind Closed Doors: IRBs and the Making of Ethical Research (University of Chicago Press, 2011.)
  56. Laws of Minnesota 2009, chapter 58; codified as Minnesota Statutes, 253B.095, subdivision 1(d)(4) and (e).
  57. Leigh Turner, “The U of M should thoroughly investigate issues in the Markingson case,” MinnPost, March 11, 2014.
  58. Mark Yarborough, Kelly Fryer-Edwards, Gail Geller, Richard R. Sharp, “Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors,” Academic Medicine 2009 April; 84(4):472-7.
  59. Mark Yarborough, Kelly Fryer-Edwards, Gail Geller, Richard R. Sharp, “Transforming the culture of biomedical research from compliance to trustworthiness: insights from nonmedical sectors,” Academic Medicine 2009 April; 84(4):472-7.
  60. Matt Lamkin, “Will the U review or whitewash a research subject’s death?” Star Tribune (Minneapolis), December 18, 2013.
  61. Matt Lamkin, Carl Elliott, “University of Minnesota research lapses show self-reform is failing,” Star Tribune (Minneapolis), February 11, 2016.
  62. Meghan Holden, “Kaler talks Markingson case, bowl game,” Minnesota Daily, December 11, 2013.
  63. Minnesota House of Representatives, Higher Education Finance and Policy Committee, April 13, 2016 (testimony on audio recording at 20 minutes.)
  64. NMS Labs, Toxicology Report, Patient name: Dan Markingson, Minnesota Regional Medical Examiner’s Office, February 14, 2008.
  65. Office of the Inspector General, U.S. Department of Health and Human Services, Institutional Review Boards: A Time for Reform, June, 1998.
  66. Office of the Legislative Auditor, State of Minnesota, A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case, March 19, 2015.
  67. Paul Tosto and Jeremy Olson, "The death of subject 13." Pioneer Press (St. Paul), May 18, 2008.
  68. Peter Aldous, “Why Are Dope-Addicted, Disgraced Doctors Running Our Drug Trials?” Matter, July 28, 2014.
  69. Public Citizen, Health Research Group, Public letter to President Eric Kaler, June 16, 2014.
  70. Richard Smith, “Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies,” PloS Medicine, May 17, 2005.
  71. Robert Klitzman, The Ethics Police: The Struggle to Make Human Research Safe (Oxford University Press, 2015), p. 79-80.
  72. Roberto Abadie, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Duke University Press, 2010.)
  73. Sabriya Rice, “Policing the ethics police: Research review boards face scrutiny as feds propose new rules,” Modern Healthcare, December 12, 2015.
  74. Sharon Matson. FDA Establishment Inspection Report, Stephen Olson MD. Report no. FEI 3004927371. July 22, 2005.
  75. Shirley Wang and Avery Johnson, “AstraZeneca Papers Raise Seroquel Issues,” Wall Street Journal, February 27, 2009.
  76. State of Minnesota Board of Social Work, Agreement for Corrective Action in the Matter of Jean M. Kenney, November 8, 2012.
  77. Susan Perry, “U of M Suspends Enrollment in Psychiatric Drug Trials in the Wake of Scathing Report on Markingson Case,” MinnPost, March 20, 2015.
  78. Susan Perry, “U of M Suspends Enrollment in Psychiatric Drug Trials in the Wake of Scathing Report on Markingson Case,” MinnPost, March 20, 2015.
  79. Trudo Lemmens and Paul Miller, “The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives,” Journal of Law, Medicine and Ethics Fall 2003; 31: 3, pp. 398-418.
  80. U.S. Department of Health and Human Services, Office for Human Research Protections, Institutional Review Board Guidebook, Cognitively Impaired Persons, Chapter 6(D), 1993.
  81. William Heisel, “The Markingson Files: Conflicts of interest in clinical trials should be transparent,” Reporting on Health, June 06, 2011.
  82. Zachary Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Johns Hopkins University Press, 2010).

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