Saturday, May 4, 2013

"He wasn't doing well in the study and refused to return and was constantly hounded by the coordinator"

In January 2003, Jean Kenney was having serious trouble recruiting subjects for the CAFÉ study. Apparently, despite her hard-sell for the study, parents of potential subjects were refusing to sign up their children.  

Consider this January 17 2003 email from Kenney to Quintiles, the CRO managing the study (see page 47).  “Having trouble with Subject 002.  His sister just died, his father has terminal cancer and now the grandmother is sick,” she writes.  “Am afraid we may be losing him.”  Kenney goes to say that she “had another person show interest from inpatient and then the parent put the pressure on and said ‘NO.’ (3rd time this has happened.)”  

Kenney concludes, “So, some frustration here because we really need to get more enrollees. We’ve had none for January and that concerns me a lot.”

When I wrote about the suicide of Dan Markingson for MotherJones magazine in 2010, I found that email alarming.  Kenney and Olson had enrolled Dan over the objections of his mother, and this email suggested a pattern of high-pressure recruitment tactics. Over the past month, however, that suspicion has been reinforced still further by several comments left on the petition to investigate the university. 

Consider, for instance, this comment:

My son went through a similar episode as it appears Dan Markingson experienced. We didn't know where to turn at first either, and finally ended up at the U-Minnesota. Big mistake. From the first clinic appointment I attended with my son it was apparent that the physician, psychiatrist had only one agenda, and that was research. I didn't seem to matter to him what the family background was as far a mental health issues, it didn't seem to make any difference what I thought, he only cared about my son being enrolled into a drug trial. "It would be in his best interest," I still remember clearly those words. I called my husband from the waiting room and he screamed through the phone no way do we want our son in some experiment. Where is/was the recognized treatment, and most shocking was we hadn't even been told a diagnosis yet. I proceeded to walk myself and my son right out of the clinic and never look backed. I can certainly feel the pain Mary Weiss must still be inflicted with. 

Shame on the U-Minnesota. Our family has learned one important lesson from the University's pathetic behavior all these years, and that is you’re just as guilty for having done nothing at all than having committed the initial act. Mrs. Weiss deserves nothing less than the truth.

Comments from other signatories recount similar stories:

A relative of my husband was also being treated in the Cafe study and his interactions with the psychiatrist and study coordinator were just as bizarre in nature as Dan Markingson's were.  He wasn't doing well in the study and refused to return and was constantly hounded by the coordinator even after informing her he was now under a private doctor's care. His private doctor’s clinic had nothing but trouble trying to obtain his medical records and were often dismissed or lied to by the University as well as the study staff. I only heard about this petition last evening from a friend looking for a group to listen to Professor Elliott talk about Dan Markingson. The University's role in covering-up the Dan Markingson case is disgraceful. Sadly, Mr. Markingson wasn't alone in dealing with unethical and unprofessional behavior from the study staff. I truly hope Governor Dayton does the right thing here and order an investigation.

And this:

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.

And finally, this comment:

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.

“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.” Of course, a cornerstone of medical research is the promise that subjects will not be punished or disadvantaged in any way if they decide to drop out of a study.  If the threat of going without psychiatric care was used to keep CAFÉ subjects in the study, that would be a very serious matter.  

Of course, none of these comments can simply be taken at face value.  They need to be investigated further before any conclusions can be drawn. (I should note, however, that each comment was signed on the petition, not left anonymously.)  Given the troubled history of the CAFE study, however, they provide still more evidence that further investigation is warranted. 

Let me finish by including a comment not from a subject or family member, but from a signatory who used to work at Fairview Hospital. 

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 firsthand 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.

Please consider signing the petition to investigate psychiatric research misconduct at the U.


2 comments:

  1. Keep it up Carl. Your persistence in doing right is inspiring.

    ReplyDelete
  2. Here’s the real deal folks, despite all denials from the principal investigator of the CAFÉ’ study and the University’s IRB who are supposedly in charge of human subjects protection regulations and training, overwhelming evidence exists that the clinical trial subjects in the CAFÉ’ study often failed to understand even the most fundamental aspects of the drug study in which they participated, such as the risks of participation, how subjects were randomized into different treatment arms, and the differences between treatment and clinical research. This simple lack of understanding undermined the ethical foundation of the CAFÉ’ trial from the onset, and the real culprits for the lack of understanding were the principal investigator and his cracker-jack study coordinator.

    From reading numerous depositions in the Markingson civil lawsuit, and contrary to signed statements on the CAFÉ’ study IRB application with the UMN, as well as FDA documents, there was no formal agenda for obtaining informed consent from mentally ill subjects, it was basically whatever worked and whomever was available did the dirty deed. The principal investigator Stephen Olson claims in a sworn deposition that he informed the IRB that he, and he alone, would be securing all the legal signed consent from every subject. He went on to state in the deposition that he personally was involved with every single subject’s enrollment. Well, the CAFÉ’ study coordinator Jean Kenney makes the sworn deposition statement that Dr. Olson was there sometimes, and then sometimes not, and if he wasn’t there, she simply went ahead and enrolled subjects and had them sign the consent form if they choose. And then there’s the little issue of the FDA investigation following the death of Dan Markingson, that reveals the little tidbit that one of the co-investigators personally enrolled about 4 subjects himself and followed those same subjects. So we now have three different versions, all supposedly telling the truth, and that still doesn’t take into consideration the University’s General Counsel’s on-going denial of any misconduct with obtaining legal consent for study enrollees, or the now infamous Evaluations to Consent documents that appear to be identical from numerous different sources.

    Once it was determined that the principal investigator was capable of blatant lies in his sworn testimony, it’s pretty obvious why the University went into damage control mode and cover-up, they had to know there were more subjects that could potentially surface with the same issues that doomed Dan Markingson.

    The one glaring common denominator from the comments left is the obvious lack of knowledge from the study enrollee regarding just what was the real purpose of the CAFÉ’ study, and if they were not doing well, who’s going to help them?

    Supposedly, Informed consent is founded on the principle of respect for autonomy, which
    means that people have the capacity to govern themselves and that this capacity should be
    respected. It’s pretty obvious that neither the principal investigator nor the study coordinator had any respect for any trial subject as far actual treatment goes; it was simply to keep the cash register going cha -ching.

    On-going informed consent was especially important in the CAFÉ’ study because trial subjects put themselves at risk of harm, at least in part to benefit society, and that supposedly the study was designed to provide subjects control over whether to participate in the drug trial based on their preferences and values. Well, the tool used for that control by the study team was coercion and harassing phone calls from the study coordinator, or a total disrespect for the well-being of the mentally ill patient by the principal investigator.

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