Thursday, March 12, 2015

For the Record: Dr. Judy Stone - What A Scathing External Report On Protections In Research Missed -- Or Ignored

Link to original piece by Dr. Judy Stone

In Part 1 about the review of clinical research protections at the UMN, I focused on the critical findings of the AAHRPP reviewers. Today I explain on what is missing from their report.

What the AAHRPP missed

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. For example, Fox 9’s Jeff Baillon reported on a patient, “Robert,” who participated in a Bifupronex trial he felt coerced into participating on. 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.

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. I’ve never worked in a unit where medicines weren’t charted. Again, it also makes monitoring for adverse events, critical to any study, impossible.

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. Is this still occurring?

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? Or does their silence on this, and other questions, reflect on their cozy relationship with the UMN? After all, the UMN pays AHHRPP for accreditation, and these shocking ethical breaches were never picked up by AAHRPP.

Note: The AAHRPP was asked to respond to these concerns and have declined to do so.*

The University’s response

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.

Kaler’s claim is a bit misleading. It is unclear that the UMN was actually “cleared” of illegal activity—specifically, the report notes: “University policy and IRB protocols reflect inconsistencies and, in some cases, appear to be at odds with Minnesota law…the prohibition against research consent by a legal guardian without a  specific court order does not appear to be applied consistently.”

While Brian Herman, Vice President for Research just announced to me and the Faculty Senate, “We will be transparent about our actions – sharing information about our progress, neither his office, that of President Kaler, IRB chairs, nor the AAHRPP reviewers would return my calls nor answer any of my written questions. They have yet to respond to many of the other important issues raised by Dr. Elliott either.

The other dubious claim from Herman was “Now, we will be accountable for taking action.” Does that mean that the VP for Research didn’t believe he was accountable for ensuring the safety of research subjects before? That’s a pretty appalling admission.

Kaler and Herman were asked for comment and declined to respond to my questions.

Looking forward

President Kaler has reiterated that the UMN must be forward looking.

To do so, I would suggest the following initial steps:

Appoint external people to the panel to implement the AAHRPP report recommendations. The people named thus far do not have credibility, since many of the problems occurred on their watch. I might suggest asking Trudo Lemmens (U. Toronto), Susan Reverby (Wellesley professor who uncovered the unethical Guatemalan syphilis experiments) for suggestions from his co-authors and almost 200 academics who called for an investigation of the UMN.

Transparency would be important and go further than talking points. That no one answered my, or others’ questions, gives the impression that nothing will change at the UMN.

Stifling of dissent by monitoring faculty and intimidating staff has to be addressed.

A Truth and Reconciliation Commission might be helpful. It is certainly warranted. In the meantime, in my opinion, the UMN must formally extend apologies to Mary Weiss, Mike Howard, “Robert” and all the others harmed in their studies. Notably, this should include Carl Elliott, who has been particularly harassed when he should, instead, be applauded for his courage, decency, and ethics.

*Correction: Anne Donahue was not contacted prior to publication. Melissa Frumkin responded to my questions, I thought for the panel of AAHRPP reviewers, with “our presence at the March 6 public forum with the UMN faculty senate concluded our involvement with this matter. We believe our report speaks for itself and have decided that we will not be available for further comment.” Donahue has since been asked to comment. If she does, the post will be updated to reflect that.

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