\nFarewell to “Molecules to Medicine” on SciAm<\/a><\/div>\nScientific American<\/font><\/strong><\/div>\nBy Judy Stone<\/div>\nDecember 15, 2014<\/div>\n<\/p>\n
… 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…<\/div>\n<\/blockquote>\nJudy Stone blogged at Scientific American<\/font><\/strong> 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<\/font><\/strong> in December. But she’s still at it, now writing as a contributor on Forbes<\/font><\/strong>. Wednesday, I linked to her reaction to the report from the external investigators [see done nothing wrong…<\/a>]: <\/div>\n\nUMN’s Clinical Research Practices: Far From ‘Beyond Reproach’<\/a><\/div>\nForbes<\/font><\/strong><\/div>\nby Judy Stone<\/div>\n3\/10\/2015<\/div>\n<\/blockquote>\nI 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<\/em>. She knows how things are supposed to be done, and so she has something of a unique perspective on this case. She ended with…<\/div>\n\nIt 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.<\/div>\n<\/blockquote>\nAnd she doesn’t disappoint, adding some valuable information not in the report about why this campaign has been about the whole program:<\/div>\n\nWhat A Scathing External Report On Protections In Research Missed — Or Ignored<\/a><\/div>\nForbes<\/font><\/strong><\/div>\nby Judy Stone<\/div>\n3\/11\/2015<\/div>\n<\/p>\n
"The five most critical unreported items, although the AAHRPP was informed of them, follow: <\/div>\n\n
- "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<\/a>. This incident spurred her to speak out about breaches in standard clinical trial conduct"… [see a paradigm…<\/a>].<\/li>\n
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"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"…<\/div>\n<\/li>\n- \n
"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"… <\/div>\n<\/li>\n- \n
"While some recusals from IRB review did occur [p. 25]<\/font><\/a>, leaving the IRB without a subject matter expert, certainly there were egregious conflicts of interest on the IRB<\/a>. For example, Dr. David Adson was Chair of the IRB panel that reviewed Markingson’s death on the CAF\u00c9 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 CAF\u00c9 trial.<\/a> It gets better. Adson chaired the IRB that approved the CAF\u00c9 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<\/a>, sponsor of the CAF\u00c9 trial, detailed in this Hastings Center report"…<\/div>\n<\/li>\n- \n
"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…<\/a> and intrinsically flawed, and dangerous…<\/font><\/a>] <\/div>\n<\/li>\n<\/ol>\n<\/blockquote>\nThis is not trivial stuff!<\/font><\/strong> 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<\/em>. And in a clinical trial, when I read the article about CAFE<\/a>, 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.<\/font><\/strong> 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!<\/font><\/strong> 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:
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