not trivial stuff!…

Posted on Thursday 12 March 2015

Scientific American
By Judy Stone
December 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…
Judy Stone blogged at Scientific American under "Molecules to Medicine" from 2010 until the end of December, 2014, when they "reorganized" and that blog was discontinued. I knew of her because of her strong support for Carl Elliot’s efforts at the University of Minnesota. She is herself a Clinical Trialist in Infectious Diseases. Her blogs have been a great resource for the facts in that case and the various issues in the Dan Merkingson case. The above is her farewell blog from Scientific American in December. But she’s still at it, now writing as a contributor on Forbes. Wednesday, I linked to her reaction to the report from the external investigators [see done nothing wrong…]:
by Judy Stone
I think she was as surprised that the Report was not a "whitewash" as the rest of us  – pleasantly surprised. But one of the things that has made her contributions so valuable is that she is herself a Trialist. She knows how things are supposed to be done, and so she has something of a unique perspective on this case. She ended with…
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.
And she doesn’t disappoint, adding some valuable information not in the report about why this campaign has been about the whole program:
by Judy Stone

"The five most critical unreported items, although the AAHRPP was informed of them, follow:
  1. "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…].
  2. "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"…
  3. "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"…
  4. "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"…
  5. "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…]
This is not trivial stuff! It’s all a big deal and we’re lucky to have Dr. Stone’s keen eye to pick it up [and Elliot’s team’s perserverence to unearth it]. Medicine is rife with procedures and details which can be maddening, but mostly they’re there for a reason. It’s not all just CYA stuff. It’s the way you, the patient, is protected from the kind of mishaps that occur when medical people shoot from the hip. And in a clinical trial, when I read the article about CAFE, it doesn’t tell me the things listed here. And these are all ethical issues too. The people doing the study are ethically bound to me, the physician, to follow the rules. Fraudulent forms? Huge COI? Spotters in the Intake Office? Undocumented medication and uninformed ward nurses? All of those are an outrageous ignoring of standard operating procedures. And without those procedures, people are going to get hurt – are going to die needlessly. These are all indicators that corners are being cut so the study is neither safe nor likely to be accurate. Like I said, this is not trivial stuff! Dr. Stone goes on to point out the obvious – that even in the face of this damning report, President Kaler is still operatig as a spin-master:
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…
Our attention was called to the Markingson case because of the way Dan was recruited and managed – things that seemed directly related to his death. But this report [and the things it left out] point to a much broader problem with the University of Minnesota Clinical Research Program in general. Almost everywhere anyone finds to look, there are signs of inattention to the usual standards of medical care, of scientific rigor, and of oversight – basic things.

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.

When this case first came to attention, the question was "Will the Administration of the University of Minnesota take this death as a serious wake-up call to ‘clean up’ their program from top to bottom?" I’m afraid that the response to this report just adds to the growing evidence that they are incapable of even seeing that it needs doing, much less adopting a mindset that might accomplish the obvious task at hand…
    March 12, 2015 | 3:56 PM

    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.

    Katie Tierney Higgins RN
    March 13, 2015 | 2:35 AM

    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 :…

    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:

    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

    March 13, 2015 | 6:07 AM

    Very graceful article by Judy Stone! Thank you! I really like to credit for credible information.

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