Demystifying drug development, clinical research, medicine, and the role ethics plays
Great posts have been written about the “end of antibiotics” and superbugs in a variety of flavors.Yesterday, the CDC issued an alarming warning about Carbapenem-Resistant Enterobacteriaceae, aka CRE...
In part one on drug testing, we looked primarily at the accuracy of evidence supporting drug testing—how often do you get false information from the tests.
I’ve been doing a lot of traveling recently, and am increasingly disturbed by the growing surveillance society and the misplaced reassurances that are used to assuage the public, coined “security theater” by Bruce Schneier...
I had the wonderful opportunity to co-moderate two sessions at this past week’s Science Online “unconference” in Raleigh, affectionately known as #scio13.
I continue on break from the UMN Markingson story as I try to make sense—although there appears none to be had—of the tragic death of Aaron Swartz. I am haunted and infuriated by the senselessness of his death and his persecution by overzealous prosecutors...
This post is in honor of Aaron Swartz. I had long considered posting my book as open access but had hesitated in doing so, even though I have long been an enthusiast about OLPC and Creative Commons...
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...
We’ve touched on some of the many disturbing things that happened during the clinical trial on which Dan Markingson committed suicide. In my first post, I asked how a psychotic, homicidal patient who was involuntarily hospitalized in a psychiatric hospital could give an informed consent for participation in a clinical trial...
There are many disturbing things that happened during the clinical trial on which Dan Markingson committed suicide. Besides the issue of consent, or lack thereof, which I raised in my last post, one of the most disturbing aspects to me has been the lack of accountability and the apparent violations of clinical practice standards, with no consequences. Zero accountability is how I have come to understand the outcome of this CAFÉ trial. Clinical Research Standards—in TheoryDespite sensationalistic trials gone wrong, there are actually principles for “Good Clinical Practice,” and numerous guidelines for the ethical conduct of clinical trials...
The suicide of Dan Markingson, a 26 year old man participating in a psychiatric trial, has again made the news, and will serve us for a life-time of study and discussion of research ethics, along with the TeGenero and Jesse Gelsinger cases. Markingson began to show signs of paranoia and delusions in 2003, believing that he needed to murder his mother...
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