Drug study recruiting at U of M questioned

  • Article by: JEREMY OLSON , Star Tribune
  • Updated: February 28, 2013 - 12:31 PM

Mentally ill patients’ consent is at the center of the controversy.

  • 13
  • Comments

  • Results per page:
leighturnerFeb. 26, 1310:58 PM

I’m one of Carl Elliott’s colleagues at the University of Minnesota Center for Bioethics. I support Professor Elliott’s request for an investigation of recruitment of study participants into clinical trials conducted by faculty members at the University of Minnesota. Such an investigation should address recruitment tactics and pay particular attention to the question of whether a generic, photocopied form with already completed answers was used to provide documentation that mentally ill individuals were competent to consent to participate in clinical studies. There should be a lengthy paper trail that can be examined in an effort to address this matter. If an identical photocopied form with predetermined answers was used during recruitment of some study participants, and there is reason to question whether such a form exists in Dan Markingson’s file, then the investigation should not be bound by a statute of limitations for filing of complaints but should instead be expanded to include all cases in which such a form might have been used. I do not know what such an investigation will find but there are enough unsettling questions to conclude that an investigation is required. Leigh Turner

17
1
canardbusterFeb. 27, 13 1:13 AM

It's too bad Mr. Turner wasn't interviewed for this story. His expertise might have provided some valuable perspective from someone who thinks about these issues constantly. Sadly, his response winds up getting equal billing with a callous, axe-grinding response that has no place in a thoughtful discussion about the vexing problem of finding qualified subjects for studies of this kind. There will always be those who demean the victims of heartbreaking psychological disorders, but that doesn't mean their crude voice has to be heard in this newspaper.

11
0
qbawb1Feb. 27, 13 7:00 AM

One of the biggest issues with human research at any university it that the Institutional Review Boards are comprised OVERWHELMINGLY of other researchers at the institution, who, are VERY reticent to deny grant proposals or question subject recruitment methods and/or human consent forms because they then FEAR that the same will impede THEIR research projects. There have been subjects serially recruited into studies such that when asked who their physician IS, they respond the researcher PI, NOT their actual family physician or internist. IRB's should have some clinical representation, but not make up 90% of the board.

6
2
tandabussFeb. 27, 13 7:48 AM

Thank you Leigh Turner and Carl Elliott. Shame on the U of M and all their high-priced lawyers. This is a travesty. I hope some heads roll.

9
1
drjudystoneFeb. 27, 13 8:14 AM

I couldn't agree with more with Leigh Turner. I write about clinical research and ethics for Scientific American (“Molecules to Medicine”). While I initially intended a one post mention of the UMN and the story of the death of a clinical trial participant, I rapidly became engrossed in the topic. The UMN “Markingson case” has now resulted in four posts, with more to follow, each illustrating a different aspect of research ethics and conduct—sadly, in my opinion, illustrating what not to do on a clinical trial. Frankly, I have been appalled at what I have learned and personally feel this case warrants much further investigation involving recruitment tactics, consent, conflicts of interest, seemingly inadequate oversight, apparent retaliation against free speech and dissent, shoddy record keeping, among others. There are numerous documents readily available on Scribd that support each of Dr. Elliott’s assertions. He has been meticulous in documenting his concerns—a valuable lesson in transparency. He should be applauded for his efforts. I believe there to be abundant evidence to warrant a reexamination of this case and other research practices in the Department of Psychiatry, not only by an internal UMN reevaluation, but preferably by outside agencies interested in human research protections. Judy Stone, MD Disclaimer: I do not know any of the parties involved. My concerns have arisen from my own exploration of the issues, based on published documents and depositions.

12
0
paulivsinFeb. 27, 13 7:44 PM

I will respectfully disagree with Dr Stone on this issue, despite my admiration for her very-well-written articles on the overall topic. In this case, an electronic version of a partially blank, but apparently duplicate, consent to evaluation form posted on scribd is categorically NOT support of his assertion. In this case, the original document should be produced for investigation. Duplicating this kind of consent form with pre-filled answers would constitute serious research misconduct -- probably serious enough to lead to debarment. As such, accusations of misconduct should be accompanied by actual evidence, NOT electronic copies of anonymous origin. When I suggested this to Dr Elliot on his blog, his answer -- that maybe the IRB was complicit in the misconduct -- was bizarre and clearly not helping to move the allegations towards resolution. I have no idea whether misconduct occurred with this form. If it has, there should be severe consequences. Unfortunately, it is unclear whether Elliott actually has evidence, or is simply engaged in broadcasting unsubstantiated allegations. That would not be terribly ethical behavior for a professional ethicist. I sincerely hope that the families involved step forward to share the evidence they have, so that we can begin discussing facts rather than speculation.

0
4
pinkmoonFeb. 28, 1312:21 AM

Ummm... didn't this happen in 2004? I know someone who was helped immensely by participating in this clinical trial, so I've followed its progress. I know that these sensational allegations were already dismissed by the FDA, the IRB, and the University. Maybe it's time for Carl Elliot to get a hobby.

0
6
meegwichFeb. 28, 13 4:46 AM

**paulivsin** Perhaps some clarification is in order, Mr. Elliott cannot produce original copies from anyone, and that includes Dan Markingson, all of the copies were distributed to patients as copies. Dan Markingson's was stapled to his "copied" consent form. In the Markingson/Weiss lawsuit no originals were produced through discovery by the University or the Ambulatory Research Center where most of the human subject's experiments took place. In the case of Dan Markingson, his copies don't match between the CAFE' study and the IRB's copies, I've looked at the copies more times than I care to remember. I'm pretty safe in assuming that there was "one" original form that was filled out and reused, and it's paper trail is long gone. Very same circumstances surrounds Dan's HIPAA release to even be in the study, photo copy upon photo copy and long gone.

4
0
paulivsinFeb. 28, 1310:42 AM

@meegwich: Thank you for the clarification. I'm certainly no lawyer, but I suppose that in most discovery periods, photocopies work just fine. My concern here is that the accusation is that not only the form was copied, but that pre-written answers were photocopied. If true, that's serious misconduct on the part of the trial team. Unfortunately, you can't establish the truth of the claim by producing an anonymous copy. Any patient file that contained the exact same form with the same answers needs to be publicly identified -- there is no reason to believe the source documents could not be found.

0
0
meegwichFeb. 28, 1311:29 AM

**paulivsin** Just to shed some light on the subject again, over the course of three or four years, numerous personal visits to the records office at Fairvew-Riverside, numerous visits to the Ambulatory Research Center and other offices through out the University, never failed to produce controversy over Dan Markingson's hospital and CAFE' study records, or lack of those records. Copies magically appeared years after Dan's death, and then other copies would just disappear from files or appear to have been altered after the fact. This behavior was common. Others that possess similar documents are likely going to produce them through some type of litigation, they are never going to trust the University's psychiatry department nor legal counsel to do the right thing. They never have. Covered in the "corrective action" against Jean Kenney was the little item of forging physicians initials on study documents, dispensing legend drugs without proper licensing and authority, etc etc...not so far fetched to think these other documents don't exist.

5
0

Comment on this story   |  

ADVERTISEMENT

Connect with twitterConnect with facebookConnect with Google+Connect with PinterestConnect with PinterestConnect with RssfeedConnect with email newsletters

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT