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2 UC Davis surgeons banned from human research

July 25
20:59 2012

SACRAMENTO, CA: Two University of California, Davis neurosurgeons have been banned from performing medical research on humans after they were accused of experimenting on dying brain cancer patients without university permission, the Sacramento Bee reported.

J. Paul Muizelaa

r and Rudolph Schrot were banned from any research on humans after the university told the federal government that both surgeons took part in what the school termed “serious and continuing noncompliance” with federal regulations, the newspaper said.
Muizelaar, the department chairman at the university’s School of Medicine since 1997, was ordered last fall to “immediately cease and desist” from any research involving human subjects, according to documents obtained by The Bee.
Schrot, an assistant professor and neurosurgeon at the university, has worked under Muizelaar for the past 13 years.
The documents show the two doctors received the consent of three terminally ill patients with malignant brain tumors to introduce bacteria into their open head wounds, under the theory that postoperative infections might prolong their lives.
After an inquiry from The Bee last year, university officials launched an investigation and determined that two of the patients developed sepsis and died, according to newspaper.
In an eight-page letter to the U.S. Food and Drug Administration in October, Harris Lewin, the university’s vice chancellor for research notified the agency about the doctors’ work, claiming that they had sidestepped procedures in introducing the bacteria into live patients’ head wounds.
“We really take these matters very seriously,” Lewin told The Bee. “That’s why we self-reported” to the FDA.
Muizelaar, 65, responded to the report by telling The Bee that he and Schrot believed the FDA had given its permission for the experiments. He described the ban as an “overreaction” by the university.

Rudolph Schrot

“And I understand it,” he said. “There are people who blatantly break the rules that endanger all of their research programs. We certainly didn’t blatantly trample any rules.”
Schrot, 44, told The Bee in an email that “the determination of `serious and repeated noncompliance’ is misleading.”
Muizelaar and Schrot also told The Bee that all three patients, in consultation with their families, gave their consent for the treatments.
The documents obtained by The Bee showed that the first patient died six weeks later after the tumor progressed. The university later determined that the patient also had developed sepsis, a life-threatening illness in which the body responds severely to bacteria or germs.
The second patient who underwent the procedure in 2010, was still alive when Lewin wrote his letter to the FDA in October 2011.
That patient was described as having a reduction in the brain tumor but also suffered a wound infection and was given antibiotics 10 months after being intentionally infected.
The patient has since died, Muizelaar said.
The third patient, who underwent surgery in 2011, soon developed sepsis and meningitis and died.
Muizelaar, who remains as neurological surgery department chairman and was honored this spring at an endowment ceremony for his appointment to the Julian R. Youmans endowed chair in neurological surgery, said he and Schrot had no financial incentive or underlying motive for the research.
Alleged violations involving experimental drugs or devices can have serious consequences for institutions and doctors, with possible enforcement actions including warning letters and the disqualifying of researchers from further clinical studies.
An FDA spokeswoman said she could not comment on the UC Davis case, or whether it would trigger a federal investigation. -AP



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