Kelly Hills (@rocza) was kind enough to call my attention to the guest post on SciAmMind by Jeffrey Lieberman, incoming president of the American Psychiatric Association (APA).   Frankly, I’m appalled by Lieberman’s post, especially as it was invited. Although masquerading as a reasoned critique, it is anything but that. Rather, the piece is [...]

This weekend, the proverbial s**t hit the fan over the Food & Drug Administration’s (FDA) decision to require an Investigational New Drug (IND) application for stool transplants—formally known as “fecal microbiota transplants (FMT)”—for the treatment of C. difficile colitis. “C. diff,” as it is known, is a severe inflammation of the bowel complicating treatment of [...]

  On Mother’s Day, May 12, ethics Professor Carl Elliott had an Op-Ed published by the Minneapolis Star Tribune, “The University of Minnesota Research Case Needs Scrutiny.”   The Star Tribune began to post comments, the first being: Minnesoda73 May. 12, 13 6:10 PM The University of Minnesota has investigated itself and found itself innocent. [...]

This research ethics series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues [...]

All that is necessary for the triumph of evil is that good men do nothing. -Edmund Burke One month ago, Mike Howard, family friend of Dan Markingson, who committed suicide while participating in a clinical trial at the UMN, launched a petition requesting that Governor Mark Dayton launch an independent investigation of research misconduct in [...]

  This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues of [...]

My message: Ask the hard questions. The Association of Health Care Journalists annual conference (#ahcj13) covered a variety of topics, with lectures and panels followed by question and answer sessions. As with many conferences, it was tough to choose between competing sessions. I learned a great deal about health care, databases, and resources to help [...]

This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotics at the University of Minnesota, his ultimate suicide while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, we’ve looked at issues of “good clinical [...]

I had the wonderful opportunity to co-moderate two sessions at this past week’s Science Online “unconference” in Raleigh, affectionately known as #scio13. Sessions are proposed and moderated by volunteers, and there is a broad range of attendees, leading to rich discussion…and lots of fun.   There were three sessions devoted to different aspects of Citizen [...]

In earlier posts, we’ve looked at issues of consent, investigator responsibilities, and conflicts of interest on the case of Dan Markingson’s suicide while participating in a clinical trial of anti-psychotics at the University of Minnesota. This time, we turn to the University’s response. Not surprisingly, the University has claimed it has no responsibility for any [...]