Wednesday, May 27, 2015

For the Record: How others see us. Recent comments in NYT about #umn

Carl Elliot has recently written a piece in the New York Times. (link)

Here are some comments on the piece:
(not #umn proud ...)

Thank you Dr. Elliott for blowing the whistle loudly and clearly. This mistreatment of the participants in these drug studies is appalling, if not criminal. As a person who conducts research with human subjects, I consider the treatment of each individual to be sacrosanct and if there are researchers who are mistreating their subjects they should be banned from conducting research. 

It's sad that at the same time the university officials were hiding the internal investigation, they were piously preaching the principles of academic honesty to their undergraduates and threatening them with expulsion. What a sham! 

Dr. Elliot appears to be calling for greater power for IRBs to regulate, or a greater role within the institution, but I fear his concerns may be applicable only to the University of Minnesota, which by his description, is seriously flawed. Any researcher (Principal Investigator or Co-I) who broke IRB rules where I've worked was fined, placed on administrative leave, or fired. My experience is that IRBs exist less to protect subjects and more to protect the institutions with which researchers are affiliated. Maybe the issue isn't the lack of power within the IRB, but the lack of will at Univ. of Minn to confront the culture within the department of Psychiatry within the college of Medicine. Its easy to blame a body with oversight duties for the failings of a research culture that reside within the college of medicine.

As taxpayer contribution to biomedical research dwindle (NIH budget adjusted for inflation keeps coming down year after year) universities and medical schools are depending more and more from pharmaceuticals and biotech companies to keep research going. There is an obvious conflict of interest between reporting unbiased scientific facts and a company need to hype their products. Thus, an increase in cases of unethical or questionable research is to be expected. At the end you get what you pay for and the companies that fund research certainly want something in return.

IRBs have the right to monitor research and the consent process. They have the right to impose restrictions and suspend research protocols. The fact that the UM IRB did not perform its duties is not a reason to do away with the IRB system; it is a call for the UM IRB to function as it is supposed to function. Unfortunately, institutional support is essential to the proper functioning of an IRB. Clearly that institutional support was completely missing here.

It is quite possible to have adequate review and protection using the IRB model, IF the university's administration is willing to support the IRB's efforts, administratively and financially. At the institution where I chaired the IRB we had a major scandal, not unlike what occurred at Minnesota. It did serve as a wake-up call for the school. The President and the deans provided facilities and funds for an infrastructure that not only enhanced initial review but follow-up reviews and announced and unannounced audits of the studies.

This is a remarkable article. Those of us who have been medical practitioners know how rare it is and how risky for a reputable clinician to come forward, stating that scandalous behavior by physicians both persists and is minimized by a University administration. "Go along to get along" has been an expectation among physicians. Consider that there are students within the University of Minnesota Department of Psychiatry, residents fellows. Their training there may now raise some eyebrows, to be sure, but what about their attitudes and values, learned from the behavior of their mentors?

Wow, I bet the author is about as welcome as a case of hives around the Center for Bioethics these days. I adore people who can and will speak courageously and with little regard for their own security.

Several questions come to mind: Have there been, or will there be, any criminal charges filed against any of the "researchers," particularly in the case of the young man's death? And how will the University punish you, Dr. Elliott, for your unusual honesty? Never mind the ethics code; you have broken the code of silence.

I am ashamed of my specialty of psychiatry. All too often, our leaders prostitute themselves to Big Pharma. Even our diagnostic manual (the "DSM") is influenced by the pharmaceutical industry, which promotes the lie that psychiatric illnesses are purely "brain diseases," along with downplaying the important psychological dimensions of these illnesses.
Clinical Professor of Psychiatry, Georgetown University School of Medicine

I applaud the bravery of Dr. Elliot for writing this piece. Ethics in research is becoming a scarce commodity. Simultaneously, more and more professionals of every stripe are parroting the phrase "evidence-based," which is truly meaningless in the way it is being used. It will take more people like Dr. Elliot, willing to stand up and speak the truth, because we can no longer rely on self-regulation.

It is important is to find better ways to distinguish the risk level of different studies. I have submitted studies at my current and other R1 universities. IRBs vary, but I have found an extraordinary amount of scrutiny for voluntary survey research on healthy, non-incarcerated adults (e.g. low risk). Every line of a recruitment email is scrutinized and it can take months for a very simple study to be approved. If similar rigor is applied to high risk studies (e.g. where a substance is ingested, or medical procedure, or a high risk population), it is shocking to me that the studies described here were approved.

At the U, there have been other whistle-blowers, including a dear friend whose career was all but destroyed because she chose to speak up. While Carl Elliot's remarks are most welcome and so necessary, they are too long in coming.

Thank you very much Dr. Elliot. Some things seem never to change. More than 40 years ago I was placed in the U of M hospital after complaining about depression. As part of an experimental program, I was given a powerful anti-psychotic medication (though there were no signs of psychosis) with almost nothing in the way of explanation. Long story short, I was extremely lucky to have survived and did so only by leaving the facility against the will of the doctor conducting the study who threatened me with "commitment" for leaving the program against his wishes. It appears that someone has finally summoned the courage to stand up to the Department of Psychiatry at the University of Minnesota.

This article is a textbook example of the importance of tenure. Dr. Elliott has made a valuable contribution to cleaning up the mess of scientific research. No doubt he will pay a price for it, but if he has tenure, his job won't be at stake. And he is an example of the importance of professional ethics, and the need to teach every emerging professional about ethical professional behavior.

"A great grey mediocrity" it was call by Dean of the Institute of Technology Athelstan Spilhaus, The university has alway been a mess. I have little interest in going back there as an alum. There was much to be said for the quality of the staff and the overall experience, yet it was dumbed down by bureaucracy. Evidently not much has changed.

This is not a new problem for the department of psychiatry at Minnesota. Nearly 20 years ago as a graduate student, I reported several very serious instances of fraud and misconduct by a principal researcher, to the chair of the department. Despite the fact that I had concrete evidence (from a paper trail) all that every came of it was a severe lecture to me about the immorality of going behind said researcher's back. I was never allowed to conduct research at that department again. 

Congratulations to Dr. Elliott for his years of work in shining light on these abuses, and much more difficult, actually moving the institution to action. In the past few weeks the New England Journal of Medicine published a series of articles defending financial compensation of academic physicians by drug companies. The author asked for instances of harm stemming from such relationships. The U of Minn provides plenty, and I supplied more in a blog last week:

If you talk to doctors in the Twin Cities, you sense they believe the Minnesota medical school is in a state of decline.

Tenure protects Professor Elliott from reprisal from his institution. Another reason to reinforce that safeguard for critics. There are too few who feel safe enough to speak truth to money.

The morning I arrived for an academic urology job at the Minneapolis V.A. in the low '90's, the Chairman of Urology resigned under pressure from the student newspaper. They had found questionable accounting in the Dept. of Urology. At the same time, the Chairman of Surgery was under indictment by the FDA for selling a drug across interstate lines without FDA approval. He was acquitted. The board of trustees had approved the business plan and there was a resignation there. So, the problems at U. Minn. Dept. of Psychiatry are not new.

Aren't the University of Minnesota hospitals owned by a Corporation, Fairview Health Services? Does Fairview have a direct say in the acceptance and oversight of research studies? Do its attorneys determine how to respond to potential scandal? If yes, are Fairview attorney responses similar to that of similar non- profit Medical Centers?

The instances--especially the horrific death of Mr. Markingson--of failures in his department at the U of M are shocking to me because of the violations of trust between patients and researchers. His anger and strong language about the violations of the I.R.B.s and its "honor code" while apparently not new to others doing research are not able to rouse me to action since the control is totally within the research community and not sensitive to public pressure. If I agree to be a participant in any future studies, I will certainly ask more questions, but that seems to be all I can do.

The instances--especially the horrific death of Mr. Markingson--of failures in his department at the U of M are shocking to me because of the violations of trust between patients and researchers. His anger and strong language about the violations of the I.R.B.s and its "honor code" while apparently not new to others doing research are not able to rouse me to action since the control is totally within the research community and not sensitive to public pressure. If I agree to be a participant in any future studies, I will certainly ask more questions, but that seems to be all I can do.

Both for his book and this column, Dr. Elliot should be lauded most vigorously. His concerns are completely relevant to this situation in which Big Pharma will do most anything to get positive research-study outcomes for its new products. Starting with Vioxx, there are numerous examples of the failure of this model to account for the complexity of human physiology, where side-effects are the rule rather than the exception.

The author fails to cite the fact that the University of Minnesota was placed on the NIH "exceptional institutions" list in 1997 (not a good thing) for their failures to monitor Dr. John Najarian"s research and clinical trials on organ transplant drugs for immunosuppression. The University supposedly recruited a senior official to oversee clinical research. We can see how successful these efforts were.

as an alum of U of M, and someone who knows the byzantine waysmof university cultures, I would suggest that the only hope for change comes not from the top ranks who have denied, lied and hidden, but from the bottom up -- faculty, students, alumni and DONORS -- unified and individually demanding that the governing Boatd and the governor mandate change. Those who spent years hiding are not the ones who will now suddenly see the light and change their ways. U of M's destruction of its reputation affects all of us at the grass roots, and the taxpayers of Minnesota as well. The masses must speak.

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