Scientific AmericanBy Judy StoneDecember 15, 2014
… Thanks, too, to the SciAm editors for having allowed me to post on topics that I was passionate about, including the problems of rural hospitals and research ethics and, in particular, having supported my series on the ethical lapses in psychiatric trials at the University of Minnesota, aka the Markingson case…
Forbesby Judy Stone3/10/2015
It is unfortunate that, in presenting their report to the UMN Faculty senate, the AAHRPP consultants refused to make any statements critical to the UMN, undermining faculty demands for real reform. In Part 2 on the UMN review, tomorrow, I address what the AAHRPP reviewers missed – or ignored – in their reporting.
Forbesby Judy Stone3/11/2015
"The five most critical unreported items, although the AAHRPP was informed of them, follow:
- "First, nurses on the psych unit did not even know if a patient was participating in a clinical trial. Thus, they wouldn’t know if a change in the patient might be due to an adverse reaction to a med… Yet Niki Gjere, a clinical nurse specialist on that unit, said she was unaware of any clinical trials being conducted then. This incident spurred her to speak out about breaches in standard clinical trial conduct"… [see a paradigm…].
"Shockingly, experimental medicines were not documented on the MAR (med administration record) or inpatient chart. One staff nurse suspects that either the physicians administered the investigational meds when they rounded or the patients received the investigational meds when they were taken to an adjacent ambulatory center. This is unheard of in any trial I did, where drug accountability for investigational meds was akin to tracking narcotics"… "Possible HIPAA violations reportedly occurred—intake people at Fairview Hospital gave the psychiatry department information about admitting diagnoses without the patients’ consent, allowing coordinators to then approach the patient about clinical trials. This is a serious breach of patient confidentiality"… "While some recusals from IRB review did occur [p. 25], leaving the IRB without a subject matter expert, certainly there were egregious conflicts of interest on the IRB. For example, Dr. David Adson was Chair of the IRB panel that reviewed Markingson’s death on the CAFÉ trial. Adson was a colleague to Dr. Olson, the Principal Investigator on that trial, and reported to Charles Schulz, Chair of his department and coinvestigator on the CAFÉ trial. It gets better. Adson chaired the IRB that approved the CAFÉ study, and then chaired the panel that “examined” the report of Markingson’s death…nothing to see here; move along… Adson had large financial conflicts of interest as well with AstraZeneca, sponsor of the CAFÉ trial, detailed in this Hastings Center report"… "Finally, the consultant AAHRP reviewers were told by faculty about seemingly fraudulent appearing forms assessing the patient’s capability to consent. While they may claim that this was not part of the charge they received from President Kaler, did they not have a moral and ethical obligation to include an apparent illegal activity in their report?"… [see living history… and intrinsically flawed, and dangerous…]
One of the most troublesome things is the response of the UMN leadership to these findings. President Kaler cheered the AAHRPP report, exclaiming, “I am particularly gratified—but not surprised—that the panel found no legal or compliance violations, affirming numerous previous reviews and accreditations of our program.” He seems oblivious to how the UMN was skewered in a report that was, in some circles, anticipated to be another whitewash. The AAHRPP slammed the IRB for failure to engage “in a meaningful process of evaluating research risk” [p. 78], for lacking “scientific expertise necessary to review studies [p. 26] and for lacking adequate protections for vulnerable patients. They scathingly note, ““Most striking was the commonly conveyed sense of doubt in leadership’s commitment to human subjects protection,” yet Kaler is proud of the UMN’s program…
Worse, the response of the UMN Administration has been to deal with criticism with a fly-swatter, as if the critics are gnats, dedicated trouble-makers, rather than principled experts bringing up legitimate concerns obvious to any other principled experts who take a serious look. This external review commissioned with its limited scope found devastating evidence – even while leaving out the damning pieces noted by Dr. Stone. The president’s comment, "the panel found no legal or compliance violations," fits with the refrain from the last post, "we did nothing wrong." Again he’s happy to report that they aren’t criminally liable – hardly a remotely appropriate standard for a medical research enterprise. It’s form over substance at its worst, and an attitude that has no place in medical research, or for that matter, medical anything. The morality of academia is then no different from the morality of the streets.
Still appalling, but akin to the way Big Tobacco deflected criticism of smoking health risks or Big Oil deflects information about fossil fuels contributing to climate change.
A detailed and concise description of the beginning of the end of ethical standards as a corner stone for the practice of medicine –in both clinical and academic research, can be found here :
http://psychrights.org/States/Texas/e…
In the couple of hours spent reading this 86 page document, “Expert witness Report” for the Texas Attorney General’s office case against J&J- 2010, I found palpable causes for the agonizing ordeals I have witnessed in child psychiatry for the past 20 years–.
I searched for this document after reading this article by Paula J. Caplan PhD:
http://www.oa.uottawa.ca/journals/aporia/articles/2015_01/commentary.pdf
Insult to injury, courtesy of Allen Frances’ ad hominem attack on the *messenger* while appearing painfully oblivious to the evidence presented by David J. Rothmans,PhD in this now publicized document.
‘Diagnosisgate’ Deconstructed and Debunked
Very graceful article by Judy Stone! Thank you! I really like to credit for credible information.
What you don’t know about anorexia treatment
All people with anorexia need treatment. As a rule, this includes seeing a specialist and having customary advising sessions. A healing center stay is required for the individuals who are genuinely underweight or who have serious restorative issues. The objectives of treatment are to restore a solid weight and good dieting propensities.
In the event that you have a dietary problem, do whatever it takes not to oppose treatment. In spite of the fact that you may be extremely perplexed about putting on weight, attempt to consider weight pick up as an existence sparing measure. With help, you can figure out how to consume well and keep your weight at a sound level.
I am sure this is not new information to many readers, but, it comes up now, so I will note it as part of my point that illness is multidimensional.
Hmmm….fancy spam??