UC Davis Chancellor Linda P.B. Katehi has directed the university's provost to conduct a comprehensive review of the events that led to a research ban for the head of the neurological surgery department. But so far Dr. J. Paul Muizelaar retains his position as department chairman. Why?
As The Bee's Marjie Lundstrom reported on Sunday, after a six-month internal investigation last year, a university panel concluded that Muizelaar, a prominent neurosurgeon, had conducted experimental treatments on terminally ill brain cancer patients without proper authorization.
According to investigators, what Muizelaar and colleague Dr. Rudolph Schrot did "constituted serious and continuing noncompliance" with university and federal research protocols.
So serious was the breach, both physicians have been ordered to "halt all research activities except as necessary to protect the safety and welfare of research participants " and to "immediately halt new enrollment on any human research on which either serves as an investigator."
In a letter to the U.S. Food and Drug Administration last October, Harris A. Lewin, the university's vice chancellor for research, outlined in great detail the ethical and regulatory missteps that led to the research ban.
The two physicians deliberately introduced bacteria into the open head wounds of brain cancer patients. Muizelaar theorized that bacteria would attack the tumors and prolong life.
In fact, all three patients treated died. In a further violation of research protocols, the bacteria used in these experimental treatments was approved for animal research only, specifically for rats. It was not approved for use in humans.
At no time were the experimental treatments formally authorized by the university's institutional review board, the panel that is supposed to sign off on all experiments involving human or animal test subjects.
Experimentation on terminal patients requires a specific set of protections for good reason. People who are, quite literally, on death's doorstep are extremely vulnerable, and therefore not always able to give informed consent.
The physicians' misconduct did not just endanger patients, it puts the university's research funding at risk.
The National Institutes of Health awarded UC Davis more than $130 million in funding last year. In the past, the NIH has withheld funding from institutions for violating research rules designed to protect patients.
University officials say none of Muizelaar's research involved state or federal grants and they don't believe any funding is in jeopardy.
In their defense, Muizelaar and Schrot told The Bee that they never considered their procedures experimental. Rather, they believed they were using "innovative treatments."
The doctors told university investigators that "at all times they believed they were acting in the best interests of their patients and that they never intended to violate any rules," Lewin wrote to the FDA.
University officials conceded that "systemic issues" within the medical center may have contributed to errors made and that "additional measures designed to avoid future confusion" have been put in place.
Nonetheless, the research ban for both remains in effect. Curiously, even after it was imposed last fall, the university named Muizelaar to fill its new Julian R. Youmans endowed chair in neurological surgery. The donor specified, university officials explained, that the chair be filled with the head of the department, a fact that begs the question: Why is Muizelaar still chairman of the department?
University officials say so far the investigations have not "impugned" his ability to fulfill his many functions as department chairman.
But they have shaken public trust in the university. That alone justifies removing Muizelaar from the chairmanship, at least until all investigations are completed.