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7/29/2019 Request that FDA Office of Scientific Investigation to investigate "evaluation to consent" forms for CAFE study
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Center for Bioethics N504 Boynton
410 Church Street
Minneapolis MN 55455
612-624-9440
Fax: 612-624-9108
www.bioethics.umn.edu
Ms. Dana Walters
Division of Scientific Investigations (HFD-45)
Office of Compliance
Center for Drug Evaluation and Research
White Oak Campus
10903 New Hampshire Ave.
BLDG 51, Rm. 5341Silver Spring, MD 20993
March 9, 2013
Dear Ms. Walters:
I am writing to request an investigation of possible fraud in a clinical trial conducted at the
University of Minnesota: Comparison of Atypicals in First Episode of Psychosis, or CAFÉ study
(ClinicalTrials.gov Identifier: NCT00034892). An inspection was conducted in 2005, and the EIRcan be found at this link:
http://www.circare.org/dw/olson_fdaeir_20050722.pdf
Over the past few years I have filed requests for investigation of a suicide in this trial to various
federal and university bodies. However, my purpose in this letter is to notify you of a new issue
that has emerged in recent weeks. I will include hyperlinks to relevant documents in the text of
this letter. I want to make it clear that I am not making an accusation. However, I do believe
that these issues warrant investigation.
On February 1, 2013, I posted a blog entry about a curiosity in the file of Dan Markingson, who
committed suicide in the CAFÉ study. University officials have repeatedly argued that
Markingson was fully competent to give his informed consent to the study, pointing to an
“evaluation to consent” form located in his chart. According to this form, which was signed and
initialed by Jean Kenney, the CAFÉ study coordinator, Markingson had given rational, informed
answers to all of the questions he had been asked before he gave informed consent. The
7/29/2019 Request that FDA Office of Scientific Investigation to investigate "evaluation to consent" forms for CAFE study
http://slidepdf.com/reader/full/request-that-fda-office-of-scientific-investigation-to-investigate-evaluation 2/3
curiosity was that Markingson’s file actually contained two slightly different versions of the
same form (posted here and here.) I asked readers of the blog and a Facebook page
(Community Alliance for Ethics in Minnesota Psychiatry) to help me figure out what could
account for the differences.
This request produced a startling response. Within hours, several people had gotten in touchwith me, saying that the charts of their family members contained exactly the same “evaluation
to consent” form. One family agreed to let me post the form that was given to them by the
Department of Psychiatry. (You can see that form here.)
In most ways, this form looks identical to one of the forms that allegedly came from Dan
Markingson. The signature of the study coordinator, Jean Kenney appears identical; the
signature of the witness, Elizabeth Lemke, appears identical; and the rubbed-out marks located
at the top of two of the documents appear identical. Most alarming of all, the “answers”
supposedly given by the research subjects appear identical. But the new form has no date, nosubject ID, no subject initials, and no mention of Unit 12, the ward in Fairview Hospital where
Dan Markingson was hospitalized.
It seems possible that someone in the Department of Psychiatry may have been using a generic,
photocopied form with pre-determined answers as documentation that mentally ill research
subjects were competent to consent to research studies. Such forms would have been
particularly important for the CAFÉ study, because they would have allowed the enrollment of
acutely psychotic subjects without getting proxy consent from their family members. For
example, Dan Markingson was enrolled in the CAFÉ study over the objections of his mother,
Mary Weiss.
It is also worth pointing out that these “evaluation to consent” forms have been submitted to
official research oversight bodies, which have relied on them to make judgments about the
conduct of the studies. For example, in a March 2004 letter to the IRB, Dr. Stephen Olson
wrote that Dan Markingson had been given an “evaluation to consent” and had answered all
the questions satisfactorily. Also, when Sharon Matson of the FDA investigated Markingson’s
suicide in the 2005 EIR that I mentioned, she cited the “evaluation to consent” as evidence of
Markingson’s competence.
I have only seen copies of three of these “evaluation to consent” forms: the one I was sent, and
the two that appeared in the file of Dan Markingson. And although I have no reason to doubt
that the families of other research subjects who contacted me have found the same forms, I
have not seen those forms for myself. That said, I feel that the evidence so far is alarming
enough to warrant an investigation. Specifically, were these “evaluation to consent” forms used
as evidence of competence for other research subjects in the Department of Psychiatry? Were
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any of those subjects in studies subject to federal oversight, such as the CATIE (Clinical
Antipsychotic Trials of Intervention Effectiveness) study, which took place at roughly the same
time as the CAFÉ study? Did any of those subjects suffer serious injuries or death?
On February 20, 2013, I notified Dr. Frances Lawrenz, the Research Integrity Officer at the
University of Minnesota, of what I had found, and asked that she investigate. She refused, ongrounds that the statute of limitations for complaints about the study had expired.
I would be grateful if you would let me know when you have received this letter. If you need
more information, I would be happy to provide it.
Yours sincerely,
Carl ElliottProfessor, Center for Bioethics
