… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Wednesday, March 13, 2013
Online petition requesting Governor Dayton
to investigate Markingson case
at the University of Minnesota
Some Background: The Markingson Case at the University of Minnesota - Follow the Money
Mike Howard has posted an online petition to Governor Mark Dayton asking him to investigate possible psychiatric research misconduct at the University of Minnesota.
[Update, March 29: 1570 people have now signed the petition. Anyone who has not done so should give a signature serious consideration.]
Those who signed the petition were asked to give some reasons for signing. What follows are selected responses:
I have a Ph.D. from the U. and regularly conduct research in the US and internationally. This type of activity is not only a potentially a gross violation of the rights of the victim, here, it also sends the message that the U of MN, Minnesota, and people associated with either come from a place where we don't hold our researchers to bare minimum ethical and legal standards.
As a faculty member at the University of Minnesota and a citizen of Minnesota I think this it is important to learn what went wrong and how we can ensure it does not happen in the future.
I was trained as a lawyer at the U of M and have practiced as a psychotherapist. I am simply appalled at this story and I want the Governor to get to the bottom of it.
The U of M has lost its way. It has come loose from its moorings in being a highly respected research institution. It is time for the citizens of Minnesota to guide it back to its former glory.
This petition is important for more reasons than space will allow to list. Having known another participant in the Cafe study and how he and his family were treated by the researcher and the coordinator is disgusting. It was stay in the study at all costs, no recommendation for a second opinion, and no referral for any psychiatric help if he didn't stay in the study. For the University of Minnesota to have conducted this charade for so long that they were not responsible is incomprehensible. If Governor Dayton will not listen then this petition needs to go to Washington DC.
As a U of Minn faculty member, I want a a thorough investigation by experts from outside the university.
I am a proud UM alumna (PhD 2004). The actions of a few can do seemingly irreparable harm to an institution that otherwise has made and continues to make honorable and significant contributions to the state and beyond. Please do not allow a powerful few at UM commit violations of BASIC ethics and academic standards unchecked! Please do not allow this harm to the reputation of our university, as has the Board of Trustees and other powerful players allowed at Penn State.
The University's behavior in this case calls into question its ability to ethically and responsibly manage any human subject research. Not only is this a personal tragedy crying out for accountability, it is shameful, unforgivable and a bruising black eye on the integrity of the U of MN. If this is what counts for oversight at the U of MN, if injured parties will be subjected in response to their efforts to get answers and seek relief, it is clearly necessary and imperative for the governor and state legislature to step in on behalf of all Minnesota citizens who may be future subjects of research.
I earned my master's degree at the University's School of Public Health. I will not give money to this institution unless and until they investigate this potential misconduct.
As an alum, I am concerned about the U's whitewash on this issue.
I am a clinical social worker with 18yrs experience. This is an appalling incidence of psychological abuse and neglect perpetrated by mental health professionals. It must be investigated. Minnesota is better than this.
This is an absolute outrage! I heard about it years ago and am completely flabbergasted that it still has not been investigated. Governor Dayton, it's up to you to hold the U of M researchers accountable for their actions.
Trying to get an adult child the mental health care they need is already difficult for parents, and in this case, the actions of the U of M are egregious. As a U of M alumni, as well as a parent who has had to deal with behaviorial health issues with family and friends, I urge Gov. Dayton to please appoint the independent committee and spare other families the grief Dan Markingson's family has experienced. The University's legal team should also be ashamed of their behavior in further victimizing this family.
Dan Markingson was a vulnerable patient made more vulnerable by this drug trial. Significant concerns raised have not been adequately addressed by the University. A number of issues were newly identified in a recent corrective action by the State Board of Social Work, which concluded that Dan Markingson's (already disputed) informed consent (functionally coerced consent?), was also subsequently invalidated (http://www.socialwork.state.mn.us/Portals/0/SO-ACA/ACA_Kenney-13622-11082012.pdf). This also implies a failure in the IRB system concerning adequate monitoring in this case. While signing in my private capacity I direct the Program in Human Rights and Health at the University of Minnesota the concern of which is vulnerable patient populations.
As a faculty member at the University of Minnesota who teaches mental health, I am ashamed my University has not investigated. We expect more.
There appears to have been a clear breach of the duty of clinical care here for the sake of making money for the department of psychiatry - the exercise involved does not deserve the name study.
As a professor of bioethics with a pragmatic and fundamentally positive outlook on biomedical research, I am appalled at the University authorities arrogant and obstinately irresponsible handling of this tragedy.
As a medical social scientist and as an alum of the U-Minn (1972), I am concerned about the appropriate protection of research subjects as well as supporting the integrity of colleagues who raise serious questions about possible ethical lapses in research.
As former Health Ombudsman in New Zealand (Health and Disability Commissioner, 2000-10) I am deeply disturbed to read of unethical behaviour by researchers and psychiatrists who enrolled Dan Markinson in a trial of antipsychotic drugs, when he was not competent to consent. It appears that evidence about potential harmful side effects of the prescribed drugs was suppressed. Dan's suicide may well be linked to the effect of the drugs he was prescribed, yet no one listened to his mother's cries for help to prevent the harm that ultimately ensued. It is now too late for Dan, but the University of Minnesota owes it to him and his mother to investigate what happened and put safeguards in places to prevent a similar tragedy happening again.
As an ethicist and University of Minnesota Faculty member, I believe it is important that my institution holds itself to the highest ethical standards. It does not seem like those standards were met in this case, with tragic results.
Because when I was obtaining the clinical experience a bioethicist needs, I spent a lot of time with people who were mentally challenged, and I learned that their vulnerabilities need to be redressed, not exploited.
And because I have two graduate degrees from the University of Minnesota, I would like to be proud of the institution that granted those degrees.
As a Senior Associate Dean for Academic Affairs at a Big Ten medical school and a practicing physician, I think medical researchers and their sponsoring institutions should be held to a high standard of ethical behavior and transparency.
If there is a question of ethics among those who work with some of the most vulnerable, then it is well worth a close look. Please support this petition.
Whilst research misconduct is unacceptable, the behaviours of this institution & its representatives is even more deplorable. Their actions effectively reduce the rights of research participants to a status lower than the commercial & self-interests of those involved. An absolute disgrace!
As the leading institution for higher learning in the state, the University of Minnesota can, and should, do better.
When a tragedy this horrific is not investigated, but rather minimized and covered up by psychiatrists and a university which should know better, you have another tragedy.
Allegations have been raised by responsible people; they should be followed up.
I am troubled by the conflicts of interest between the drug industry and medical researchers and the harm it can do. And I am equally troubled by the University of Minnesota's apparent lack of willingness to investigate evidence of wrong-doing on the part of its researchers.
The coverage of this case in the Minneapolis Star-Tribune and elsewhere generates reason to be deeply worried about possible research misconduct at the University of Minnesota. The potential misconduct appears to be serious enough that an independent investigation, located outside the university, is necessary.
As a clinical researcher I am deeply troubled by this case. An investigation is needed to shed further light on what transpired, so that safety of future research partners can be assured.
Because I have worked in Psychiatric Research for close to 30 years and I find the response from UM and the sponsor to be unacceptable.
I have followed this particular case since it piqued my interested back a few years ago with an article in the Pioneer Press from St Paul. I have tried to keep an open mind and understand the University's denials of any wrongdoing. From everything I have been able to gather researching this I've come to the same conclusion over and over again. The UMN is wrong and they know it. Their repeated steps to block any type of independent investigation is disgusting. The University is acting exactly like the pharmaceutical company, if we can control the data then we can control the outcome. As I see it, Governor Dayton has no option but to order an investigation.
I teach biomedical ethics, and every student ever to take my class could tell you why this study design was profoundly immoral.
As someone with a keen interest in research ethics this appears to be a horrible case of ongoing Ostrich like behaviour from the institution involved. The treatment of Mary Weiss has been disgraceful, and at the minimum an external investigation is warranted. A well administered institution would be requesting one themselves to demonstrate that they had nothing to hide.
An investigation into these allegations is a matter of integrity, not just for clinical trial data, but for the integrity of U of M, its leadership, and the very structure of research protections in the US. Please do the right thing and investigate.
I am a graduate (CLA, 1981) and ashamed of the way the University continues to handle this tragic case. According to the Board of Regents, Minnesota is committed “to the advancement of learning and the search for truth...." Let the whole story about Dan Markingson and the clinical trial come to light. The protection of research subjects is a matter of great public import that demands public accountability.
As an academic psychiatrist and a director of a psychiatry residency program, I am appalled by the circumstances surrounding this case. While I was deeply concerned about the recruitment and management of this particular study and the death of this patient, I am perhaps even more alarmed by the attempts to avoid and/or distort an appropriate and objective inquiry. When there is morbidity and mortality associated with any clinical interaction, we are obligated to make sure that we do anything and everything to make sure it doesn't happen again. Many times this means asking for help and accepting constructive criticism. I urge the University of Minnesota to do the right thing: appoint an external panel to conduct a thorough, independent and transparent investigation.
I am an academic in a medical ethics center. Dan Markington's recruitment and retention in this study appears to have violated the most basic principles of research ethics. There must be an independent investigation.
The UMN handling of this whole affair from day one has been nothing short of appalling. Having a family member dealing with similar issues that plagued Mr. Markingson we have followed the course of this case since first hearing about it a number of years back. My wife and I were actually sitting in the conference room at the Capital the morning that Mary Weiss and Professor Elliott gave comments on what became Dan's Law and so sickened by what happened to this young man and the apparent lack of respect and callous disregard shown by the University. We were just as appalled by the testimony of Minnesota NAMI, it was as if their goal wasn't family oriented, but instead preferred to be look out for their financial partner the UMN psychiatry department. This petition is so long overdue.
The basic facts in this case and the concerns of bioethicists at the University of Minnesota warrant a serious independent investigation into this matter.
My condolences to this man's mother. We have mental illness in our family and no one should ever be treated this way. This case is appalling and the university should be taking steps to prevent its re-occurrence.
Earlier investigations into this case dismissed it on technicalities. I believe it is crucial to investigate the actual issues at stake in this case, especially as increasing numbers of people are being asked to participate in a wide range of clinical trials, thereby blurring boundaries between treatment and research. [U of M faculty]
As a journalist who has reported for national consumer magazines on the problems in clinical trials of pharmaceuticals, conflicts of interest in clinical trials, and the special problems in the research on atypical antipsychotics, I find the unwillingness of the University to investigate the circumstances in this case to be unprofessional and unbecoming of an academic institution. As a citizen of Minnesota I find the administration's intransigence a blight on our state.
As a bioethicist, I am deeply concerned about the failure in this case to investigate a failure to protect the most vulnerable among us.
Quite a number of members of my family rely on psychiatric medications to help their daily functioning. As a parent who has had to assist both of our children through neurological issues that arose as they grew up, I find the lack of oversight in how the study at U of MN was conducted appalling. This has to stop.
Misconduct in science can lead to horrible results. Being a scientist myself, I must (just like the bioethicists at the U of Minnesota) insist on a full investigation of this case.
I have just retired as a Professor of English at Furman in Greenville, SC. Matters such as this should be the concern of faculty members everywhere.
Having a family member suffering from schizophrenia and made the regrettable decision to seek treatment at the University of Minnesota. He was viewed as nothing more than a lab-rat by the principal investigator who left no doubt as to where his pay check was coming from, the drug sponsor. This behavior from the University is nothing new, it's just taken the courage and determination of a select few patriots to say never again.
Being a UMN grad and having worked at Riverside years ago I have very vivid recall on how patients were being recruited for clinical studies no matter what their current situation was or diagnosis. I witnessed first hand what so-called psychiatric research was all about. There is no way that the data collected in some of those studies had any scientific validity. From what I've heard and read about the Markingson case it was business as usual at the UMN department of psychiatry.
Attended U of MN Medical School. then U of MN Psychiatry Residency - ashamed of the Psychiatry Department - have been in private practice since 1977 - Have seen first hand the hijacking of Psychiatry by BigPharma.
As an alumnus of the University of Minnesota and a former Student Representative to the Board of Regents, I believe strongly that the University has an obligation to conduct itself in the most ethical way possible. My own investigations into the matter of the Markingson case and the CAFE trial indicate that there were serious ethical lapses on the part of the University and especially the Department of Psychiatry. Further documentation by my friend Carl Elliott, one of the premier bioethicists in America, have convinced me that an outside investigation is necessary to remedy serious structural problems with the relationship between the University and industry in conducting scientific research. A man has died; a mother grieves; and I cannot sit idly by and do nothing as a community I care about - the University of Minnesota - does nothing to make this right. I urge Governor Dayton to launch and investigation to help bring this matter to an ethical conclusion.
The University uses the FDA investigation in 2005 as a primary reason to reject another investigation. But in 2012 the Minnesota Board of Social Work took corrective action against the social worker who was the study coordinator.Perhaps the most damning finding was that "there were critical omissions in [the social worker's] documentation that were relevant to suicide prevention." See Corrective Action at http://ptable.blogspot.com/2012/11/corrective-action-in-markingson-trial.html#links.The response from the U of M General Counsel was that the social worker is no longer an employee of the University. This is the response of an institution that places the protection of its reputation ahead of protection of the patient. [U of M alum]
An independent investiagation has now become absolutely necessary. The scandal is shameful. The response of the administration of the University of Minnesota has been even more shameful. By the way, I did my postdoctoral fellowship in bioethics at the University of Minnesota.
As a faculty member at a University (Penn State) now notorious for failing to investigate abuses, I find the refusal of the University of Minnesota to confront this scandal sadly familiar. Granted that the abuses that occurred here were of a very different nature unfolding in very different circumstances, our experience should nonetheless be evidence enough for any institution that the only way forward when abuses have occurred is a thorough, transparent investigation conducted by an independent authority.
I'm saddened to say that I've lost faith in the University of Minnesota hospital system. Stories of physician conflict of interest impacting patient care, physician negligence, corrupt clinical trials, and nonexistent accountability for unjust practices make me nervous whenever I hear that someone I care about is or will be seeking critical medical care at the UofM. Quite certainly, not every physician or clinic at the UofM is guilty of immoral and illegal practices. But something needs to be done to convince patients that we will receive the best care possible at the UofM if we seek medical attention there. Patients need to be able to trust their physicians, not worry as to whether our lives are in greater jeopardy seeking medical care from them than elsewhere. What if Dan hadn’t first been turned away from another full hospital before going to the UofM? I suspect that he would be alive and well today. It’s important to me that the UofM's Department of Psychiatry is investigated because, speaking as a patient, an ethicist, and an advocate of patients’ rights, it is beyond frightening that what happened to Dan was and continues to be dismissed and discarded by an institution that should be fighting for patients and their families, not against them.
I am a professional bioethicist and expert on research ethics, and am deeply concerned by the apparent misconduct, and the failure to investigate appropriately.
As a mental health consumer, I find this unethical research appalling.
My Dad was a mental health professional who spent his life helping those in the most need. And the idea of taking advantage of a mentally ill person is, obviously, reprehensible. So let's investigate, open our eyes, and see what happened here.
I am against psychiatric coercion in all its forms, I am against the pharmaceutical industry's culture of greed, and I am against any institution that decides the best practice involves circling the wagons.There are clear grounds for an investigation here. Conducting an independent investigation is both prudent and moral.
I'm a University of Minnesota alum and I'm outraged by the school's response to this scandal. UMN researchers effectively forced a mentally ill and dangerous young man into a clinical trial -- over his mother's objections -- and he then killed himself, just as his mother had warned. There is substantial evidence of multiple forms of misconduct, some of which are felonies. The trial's coordinator has been censured. The Minnesota legislature passed a law to avoid some of these exploitative practices in the future. Yet when called upon to investigate the conduct of its own employees, the University's response amounts to "Why would we do that? We've already gotten away with this!"
Published reports regarding the Markingson case are very disturbing. This is not how we should care for vulnerable people suffering from mental illness.
As a bioethics and law professor, I have been profoundly disappointed and dismayed by the lack of serious investigation by the University of Minnesota and various US agencies mandated to protect human research subjects into what happened in the Dan Markingson case and in other cases of alleged breaches of research ethics and research subject protection standards at the University of Minnesota. There clearly are sufficient indicia to warrant a full fledged investigation, yet the University and other agencies seem to be hiding behind formal procedural rules to avoid any further inquiry. This is unacceptable for any academic institution, let alone a publicly funded institution.
As a bioethicist who teaches research ethics, I constantly preach the importance of protecting vulnerable research subjects. In the face of possible misconduct, it is critical that there is full transparency and accountability.
To call this merely shameful would be wholly inadequate. There must be a thorough and independent investigation of the University's treatment of Dan Markingson, its conduct in related litigation, and its attempts to intimidate critics into silence.
The academic community must practice what its preaches: transparency, integrity, and respect for the rights of all. I urge other ethicists to join me calling for the university to investigate the Markingson case and to review its procedures for protecting research subjects.
The ethical issues here are severe, and are a public health concern, not only for citizens of Minnesota, but any citizen anywhere whose life, be it theirs, family, or friends, is touched by use of anti-depressants.
I am a University of Minnesota alum, and I am ashamed of my alma mater right now.
As a philosopher, bioethicist, and scholar I continue to be saddened by the failure to have this situation appropriately investigated. Clearly there is wrongdoing occuring here. The sources of it need to be determined and steps taken to ensure the problems do not occur again.
Correcting this flagrant disregard for the expressed wishes of the person under care and his mother cannot be tolerated. This is exactly why the Nuremberg Code was developed and why the principle of informed consent is #1 on the list of 10 standards.
I am a professional bioethicist, and to me the attitude of the university to bend any rule to forestall an investigation is appalling.
There is substantial corruption in psychiatry, which I have witnessed again and again during my own psychiatry training and career. This needs to be further investigated.
I have worked as a lab assistant according to IRB rules, obtained informed consent and cared for the patients in our clinical trials. Dan's case is preposterous and deserves investigation.
The reputation of academic research - particularly at U of Minnesota - has been irreparably tarnished by this tragic case. Not too late to do the right thing.
It is essential that clinical trial participants be protected and that investigators be accountable for their actions. Lives are at stake - not just the lives of trial participants, but also the lives of potential users of pharmaceuticals.
As an American academic residing and teaching ethics in Israel, I am concerned about the possibility of such serious miscounduct and suspected cover-up in a respected American university, especially one supported by the state!
This petition is important to my family for every single reason already stated by signers. I don't believe for a moment that the University has any idea just how many more families could put themselves in Mary Weiss's shoes. Shame on the University and shame on them for allowing the exploitation of vulnerable mentally ill people for the sake of padding the coffers of the department of psychiatry.
The CAFE study has actually been used in my classes to demonstrate how NOT to do research and provide care ethically.
Mary Weiss’ lawsuit against the University of Minnesota was dismissed on a technicality. The University used a financial threat to intimidate Weiss into giving up her right to appeal. Why would the University prevent Weiss from proceeding with this case unless it had something to hide? Threatening the victim is surely bad publicity for the University. There’s something here that doesn’t make sense. The accumulated discrepancies – unsigned and illegal HIPAA forms, duplicate consent forms -- demand an independent investigation.
This situation represents not only a violation of civil rights but total disregard for human life. As a researcher myself I appreciate the need to maintain the highest standards and most stringent safeguards protecting the well-being of research subjects. This kind of thing is a crime and a disgrace to us all.
Something is rotten in the State of Minnesota.
I am a graduate of the University of Minnesota and want to be proud of my school, but following this case has made me deeply ashamed.
Minnesota owes much more to Mary Weiss than this investigation, but for now, it's the least we can do.
Please investigate (U of MN alumna)
The UMN has had 9 years to make this right and they have taken 9 years to perfect the deniable attitude and their refusal isn't based on exonerated facts its based on the fear of the data that might become public. This University sickens me.
It's so apparent that the University cannot regulate itself nor honestly investigate any issues regarding the department of psychiatry or the out-patient psychiatry clinic. Their behavior has so tarnished their reputation. I seriously doubt it will ever recover.
As a University of Minnesota faculty member and alum, I consider this situation to be disgraceful. We must look into the matter fairly and expeditiously. And then we must assure that it never happens again.The behavior of the University of Minnesota regarding the Markingson case is disgusting and shameful.
Unethical experiments on people should cease.
It is critical to maintain the integrity of clinical trials. This case needs to be thoroughly investigated in order to insure that all precautions and protections were in place for the protection of research subjects.
I have written about this case for Scientific American ("Molecules to Medicine" blog. The University has been asked repeatedly to have an outside investigation, and have not agreed to do so.
As a clinical researcher, I believe the evidence presented about this case raises many important questions that are, as yet, unresolved.
I support this petition as a way to get answers, particularly to the new evidence that has emerged that raises more concerns not only about the CAFE trial, but about other trials involving the department and NIH research.
We need transparency to resolve these concerns, and this now requires an outside investigation.
The University may have violated the trust of the public when it took money from a drug company and signed up Minnesota's most vulnerable citizens to participate in a trial. Please investigate.
at 11:31 AM