U disputes claim of 'rubber-stamping' patients into drug research

  • Article by: Jeremy Olson , Star Tribune
  • Updated: March 20, 2013 - 11:38 PM

Officials say mentally ill research subjects were screened carefully.

  • 6
  • Comments

  • Results per page:
  • 1 - 6 of 6
sleestakMar. 21, 13 9:00 AM

To my knowledge the only thing the University of Minnesota rubber stamps is contracts for terrible coaches and $700,000 checks to U leadership alma maters...

4
1
drjudystoneMar. 21, 13 9:34 AM

Thank you for efforts towards a balanced report. I would add a couple of details, in part from my long experience conducting clinical research: --Prof. Elliott raises many questions that deserve better answers. The UMN could answer the question re the forms, by providing redacted copies of the evaluation to consent forms--and should do so not only for the CAFE trial, but for all of the studies involving that investigator and social worker/study coordinator. This includes the CATIE trial. --The Minnesota Board of Social Work found significant fault with the coordinator’s behavior and record keeping, including the coordinator’s failures of documentation and her signing forms with the investigator’s initials. I address this in my Scientific American series of posts, A Clinical Trial and Suicide Leave Many Questions: Part 2: Investigator Responsibilities (Dec 13, 2012). --The investigation by the FDA was remarkably superficial and limited in scope. I explain in SciAm Part 4: The UMN’s Response (Jan 8, 2013 post). --The University was dismissed from the suit on a technicality—that it had sovereign immunity, not that there was no foundation to the Markingson family claims. --The University has been somewhat less than forthcoming with me in response to questions I have posed. I will write about this in an upcoming post. --At this point, questions are being framed by the UMN as “allegations” against them and are all fielded by the Office of the General Counsel. While perhaps understandable from their perspective, this creates a climate of intimidation, chilling other faculty dissent. It also defeats any claim they have of transparency. Because of these concerns, I support Dr. Elliott’s call that there needs to be an impartial and independent investigation. Judy Stone, MD "Molecules to Medicine" blog on Scientific American

6
0
mchristiMar. 21, 1310:52 AM

Missing in many of the articles on this case is both detailed descriptions of the study and how participation of the study supposedly contributed to the suicide of Dan Markingson. What I've read about the CAFE study, it was designed to compare the effectiveness of already approved drugs used in standard practice. It didn't involve not treating certain patients or giving them placebos. Further, the study's findings showed very little difference in the outcomes or the rates of cessation of treatment among the various drugs studied. This makes it rather hard to see how participation in the study, regardless of any issues of properly obtained consent, contributed to Mr. Markingson's death when he was being treated for an illness with a markedly increased risk for suicide. There are many unanswered questions regarding the basic premise of these concerns that this and other articles leave untouched.

2
1
drjudystoneMar. 21, 1311:20 AM

to mchristi: There is a huge difference, even though the drugs were otherwise available. Normally, if someone is not responding well to Rx, the patient is changed to another medication or additional meds are added to their regimen. This was not done with Markingson, specifically because it was prohibited by the protocol. And he was continued despite various notations (in the deposition) that he was not doing all that well and despite his mother's pleading warning that he was at risk of suicide--a warning that the University did not respond to in any timely fashion. Hope that clarifies why the study participation is relevant. More detail in my continuing series. Judy Stone, MD "Molecules to Medicine" blog on Scientific American

3
0
kismet35Mar. 21, 1311:36 AM

From following this tragedy for years now and reading the different accounts that have become available, I'm more convinced than ever that the University has something to hide or has simply made the decision that no matter what comes out they've determined that no fault can ever be found. How would they ever explain that? In the article the University's attorney is quoted as saying if there are different forms out there that people should bring them in and let the University have a look at them. That's one of the most ludicrous statements I think I've ever heard. Does he really think people would trust him or the University at this point? It's a whole lot of the Fox-guarding the hen-house.

2
0
mchristiMar. 21, 1311:52 AM

Judy Stone, then the problem isn't participation in the study but rather the study protocols. Not adjusting the medication of a patient that needs to have their medication changed is a problem, and here would appear to undermine the purpose of the study. The consent form issue raised by Carl Elliott may not be unimportant in general, but given your comment above, it is a distraction from the central ethical issue of placing study protocol above treatment needs for a patient.

3
1
  • 1 - 6 of 6

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

question of the day

Poll: Who wins tonight's Game 4?

Weekly Question

ADVERTISEMENT