Wednesday, November 21, 2012

Why research subjects in the CATIE study should be alarmed

The suicide of Dan Markingson at the University of Minnesota has brought notoriety to the CAFÉ study and its site investigators, Stephen Olson and Charles Schulz.  But the “corrective action” recently issued by the Minnesota Board of Social Work against the CAFÉ study coordinator, Jean Kenney, has raised another disturbing question.  Kenney was not just the study coordinator for the CAFÉ study; she also worked on the CATIE study.  Kenney’s ethical violations in the CAFÉ study were extensive and alarming.  Did they occur in the CATIE study as well?

Like the CAFÉ study, the CATIE study compared several atypical antipsychotics in the treatment of patients with schizophrenia.  Olson was the University of Minnesota site investigator for both studies.  Unlike the CAFÉ study, however, the CATIE study has been enormously influential.  By 2011, according to Jeffrey Lieberman, it had been cited in the medical literature over 1600 times. And unlike the CAFÉ study, which was sponsored by AstraZeneca, the CATIE study was backed by federal dollars.  It was funded by the NIMH and enrolled nearly 1500 subjects. If wrongdoing were discovered in the CATIE study, the consequences could be far-reaching.

According to the Board of Social Work, Kenney had responsibility for administering prescription drugs to research subjects and assessing their side-effects – including potentially life-threatening effects such as akathisia – despite the fact that she had no medical training.  She made significant mistakes about a medical diagnosis and medication dosage, and she apparently forged the initials of a physician on the medical chart.  When Markingson’s mother, Mary Weiss, left “alarming voicemail messages” warning that her son might commit suicide, Kenney failed to respond adequately.

Perhaps most significantly, when AstraZeneca and the CAFÉ study sponsors issued a safety alert about the risks of diabetes and hyperglycemia for patients taking Seroquel, Kenney failed to inform research subjects.  In fact, the principal investigator for the University of Minnesota site, Stephen Olson, did not even ask the IRB to approve a revised consent form until May 10, 2004 – over four months after the first safety alert was issued.  As the Board of Social Work pointed out, the failure to inform a research subject of these new risks would effectively invalidate that subject’s original informed consent.

Did Kenney and Olson also fail to inform research subjects in the CATIE study of these new risks?  The safety alerts for Zyprexa and Risperdal – which, like Seroquel, were study drugs in the CATIE study – were issued in March and August 2004, respectively. The CATIE study would have still been going on during that period.

If officials at the University of Minnesota were genuinely concerned about protecting research subjects in clinical trials, it would take the Kenney “corrective action” as a reason to look into the conduct of the CATIE study.  Given their reaction to the Markingson case, there is no reason to think that will happen.  However, if you or anyone you know was a subject in the CATIE study (or the CAFÉ study) and would like to talk to someone about your concerns, please feel free to get in touch with me.

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