I’ve just posted copies of Mike Howard’s 2010 complaint to the University of Minnesota’s Board of Regents about Stephen Olson, as well as the reply (nearly a year later) from Mark Rotenberg, the General Counsel for the university. Both documents are worth re-reading in light of the recent “corrective action” against Jean Kenney, Olson’s study coordinator, issued by the Minnesota Board of Social Work. There is a lot to comment on here, but let me just point out one striking disagreement between Rotenberg and the Board of Social Work.
In his complaint, Mike Howard argues that Olson had Kenney dispense prescription drugs and assess their side effects even though she had no medical training. According to the Board of Social Work, which responded to a similar complaint, Howard was absolutely right. The Board states that Kenney was unqualified to dispense prescription drugs, monitor side-effects or handle adverse events. In fact, her actions were in violation of the university's own policy. Yet Rotenberg claims that for Olson to delegate these medical responsibilities to Kenney was completely appropriate and “entirely within IRB and Good Clinical Practice guidelines.”
Something’s not right here.
You can look at the documents for yourself – there is a lot more to see -- but here is a summary of this particular disagreement.
In his complaint, Howard writes:
Dr. Olson delegated the dispensing of very powerful antipsychotic drugs to a study coordinator not licensed to dispense drugs, who had received no prior training nor education regarding how these drugs are taken, the severe side effects that an enrollee might experience, consequences for stopping the drug unexpectedly and the experience to monitor whether the study drugs are appropriate for the symptoms being treated and are having the desired effect.
Here is what Rotenberg wrote in reply to Howard:
Dr. Olson was assisted in the CAFE Study by a research coordinator who had a bachelor's degree in psychology and a master's degree in social work. As the study coordinator, this person worked under the close supervision of Dr. Olson as the principal investigator.
Throughout the study, Dr. Olson was responsible for "dispensing" the medication in his capacity as principal investigator. Under Dr. Olson's supervision, the study coordinator merely gave the pre-packaged and marked bottles of pills to Mr. Markingson. Mr. Markingson, upon returning to Theo House, the half-way house where he resided, would then give the bottle of medication to the Theo House staff who oversaw the delivery of the medication to him on a daily basis, and helped assure that he was taking the right doses at the right time.
Dr. Olson was responsible for the prescription of the medication under study protocol. He discussed the medication side-effects with Mr. Markingson. He also discussed these medications with the study coordinator and closely supervised her activity. This is standard procedure in out-patient clinical trials and was conducted entirely within IRB and Good Clinical Practice guidelines. Neither the IRB nor the FDA had any questions that proper procedures were followed for dispensing of study drug.
But the Board of Social Work had very different response:
Although Licensee had no formal medical training or experience with respect to obtaining medical histories or handling adverse drug events, Licensee regularly completed forms, gathered information, and performed tasks that were beyond Licensee's competence and scope of practice as a clinical social worker. Licensee also made numerous documentation errors in the performance of these tasks.
Licensee dispensed legend prescription drugs without authorization and in violation of the University's policy.
Between November 24, 2003 and April 28, 2004, Licensee completed forms assessing the Barnes Rating Scale for drug-induced akathisia, as well as weight, vital signs, and waistlhip/height measurements. Licensee also completed the Simpson-Angus Abbreviated Examination of gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, and tremor.
On nine occasions, beginning on December 5, 2003, Licensee completed the Adverse Event/Medical Diagnosis form, which called for a "clinician rating of severity" for orthostatic faintness, dry mouth, constipation, sialorrhea, gynecomastia, galactorrhea, sex drive, sexual arousal, sexual orgasm, incontinence/nocturia, urinary hesitancy, skin rash, hypersomnia, weight gain, akathisia, and akinesia. On two additional occasions, Licensee delegated the task of completing this form to a social work intern, who Licensee was supervising.
It is no surprise that Rotenberg did not comment on these findings in his statement to the press about the corrective action against Kenney. I hope to post more on Rotenberg’s response to other aspects of Howard’s complaint very soon.