Thursday, May 2, 2013

The CAFE study numbers don't add up. Is there a reason for that?

Was Dan Markingson the only psychiatric research subject harmed at the University of Minnesota?

One pressing reason for a thorough, impartial investigation is the possibility that Dan was not alone. The worry that other subjects may have been harmed or mistreated was reinforced by the extensive wrongdoing documented in the “corrective action” against Jean Kenney, the CAFÉ study coordinator, issued by the Board of Social Work last fall. Yet despite this accumulating body of evidence, the university has diligently stonewalled every effort I have made to uncover information about other CAFÉ study subjects.

One important question: exactly how many subjects were enrolled in the CAFÉ study? You might think that this would be an easy question to answer, but with the CAFÉ study, nothing is easy. Consider this exchange from the page 40 of the deposition of Jean Kenney, the study coordinator.

Q. All right. Do you recall how many patients you recruited for the CAFÉ Study, or how many patients were recruited at the University of Minnesota site for this CAFÉ Study?

A. I do not remember the exact number. I know it was in the twenties.

 “In the twenties,” says Kenney. Yet when the FDA conducted an inspection in 2005, Olson reported only 17 subjects. That figure is also the one that Olson used in 2006, when he gave a presentation on the CAFÉ study at an International Congress of Schizophrenia satellite session. And both of these figures appear to be contradicted by a 2005 document from Quintiles that lists payments to the university for 18 subjects.

Seventeen, eighteen and twenty-something: these are serious discrepancies. It is possible there is a benign explanation for these different numbers -- memory lapses, billing mistakes, sloppy paperwork, misinterpretations of the questions being asked -- although by this point, benign explanations for problems in the CAFÉ study are becoming increasingly hard to credit. The other possibility, of course, is that the numbers are being intentionally misreported. The question is: why?

I can speculate, although before I do that, let me emphasize that these are speculations, not allegations. I simply want to explain why I believe that an investigation is warranted. I can think of at least three reasons why Olson -- or university officials -- might misreport the number of subjects in a trial.

One reason might be connected to the disputed “evaluation to consent” and HIPAA forms. If CAFÉ study staff failed to get signed HIPAA authorizations from some subjects, or used photocopied “evaluation to consent” forms, then claiming that only 17 subjects were enrolled rather than a number “in the twenties” could be a way of preventing anyone from seeing the additional study records.  (According to CAFE study protocol, all subjects who were screened for the study were asked to sign consent forms, even if they were dropped after being screened.)

A second reason, at least for Olson, could be to make the data from the University of Minnesota site look better. If some subjects enrolled at the Minnesota site did poorly in the trial, hiding their participation could produce better results.

 A third reason, related to the second, could be more sinister. If a subject died or was injured in the trial, then excluding that subject could be a way of hiding that death or injury from external scrutiny.

Of course, there may also be another, more benign explanation, and if the university had a legitimate, impartial avenue for examining questions such as these, I would request an investigation. Unfortunately, my previous requests for investigation have simply been turned over to the Office of the General Counsel, which cannot exactly be considered impartial.

2 comments:

  1. Well, let's see. Jean Kenney tells the truth in her deposition regarding the number of enrolled subjects, the Principal Investigator Stephen Olson cites a different number, and the mouth-piece of the University attorney Mark Rotenberg comes up with an entirely different number. Now folks, this is science at it's best at the University of Minnesota. If you try and guess who's right...you have a one-in-three chance of being right...or scientifically speaking 33 1/3%. I personally don't like those odds. The problem is, the disciplined study coordinator who has the least to lose is probably the most correct. Mark Rotenberg has steadfastly stated as an example that Dan Markingson was not considered enrolled until he was actually given a study drug. Pay no attention to the fact that he was being weened off his standard treatment and actually attending CAFE' study visits and being "paid" for those visits...according to Rotenberg he wasn't enrolled yet...gee'z now I'm wondering if the University will file a claim against Dan's estate wanting the CAFE' study payments back since Rotenberg claims he wasn't enrolled. This whole crap with the UMN and the CAFE' study is a sick as it can be, there is nothing that they have done right, and everything that they continue to cover-up and deny. It's beyond pathetic and shameful.

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  2. I probably should add that my previous comment wasn't an allegation.....it's the cold hard facts, and if anyone thinks differently, well, I'm sure the UMN has a study for you. Just remember your'e not enrolled until Mark Rotenberg says you are, you can't cash those study visits checks because your'e not actually enrolled, and if Stevie Olson happens to be your principal investigator your'e already in a whole hell of a lot of trouble. Good luck with all that though.

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