UC Davis neurosurgeon department chair steps down pending investigation into his research
07/28/2012 12:00 AM
10/08/2014 10:37 AM
A UC Davis neurosurgeon accused of performing unauthorized research on humans has "temporarily relinquished" his position as chairman of the department of neurological surgery, the university confirmed Friday.
Dr. J. Paul Muizelaar, who was hired for the top post in 1997, is the subject of a new university investigation into surgical procedures he and a colleague performed on terminally ill brain cancer patients.
Dr. James E. Boggan will step in as acting chairman of the department of neurological surgery pending the outcome of the investigation.
Muizelaar and an underling, Dr. Rudolph J. Schrot, were banned last fall from performing research on humans after the university determined they had proceeded without official permission.
As reported in Sunday's Bee, the doctors obtained the consent of three patients with malignant brain tumors to open their skulls and insert bacteria, theorizing an infection might prolong their lives. Two of the patients developed sepsis and died, the university determined. Muizelaar told The Bee the other patient lived for months but has since died.
University documents show that the bacteria introduced into the live patients were restricted to use on rats, not human beings.
Muizelaar and Schrot continue to see patients, even though both have been ordered to halt all research work involving human subjects.
"I welcome a thorough review so that all the facts can be known," Muizelaar said Friday in a prepared statement.
A spokeswoman for UC Davis Health System said "there will be no further system statement on this or other personnel actions."
Both Muizelaar and Schrot previously told The Bee they were providing "innovative treatment" to their dying patients – not conducting research – and that they believed they had been given the go-ahead.
Muizelaar was moved out of his leadership role just days after UC Davis Chancellor Linda P.B. Katehi called for a new top-level investigation into the controversy. That "comprehensive" review is being led by Ralph J. Hexter, the university's provost and executive vice chancellor.
The provost's investigation follows a six-month probe last year by the university's Institutional Review Board, or IRB. The board, which includes members of the public, is made up of three committees charged with protecting the rights and welfare of human research subjects.
Last year's internal investigation – which began in March 2011 when the IRB learned that the doctors wanted to infect up to five more patients – concluded that Muizelaar and Schrot had engaged in "serious and continuing noncompliance."
In a detailed letter last October to the U.S. Food and Drug Administration, Harris A. Lewin, the university's vice chancellor for research, admitted to the "potentially unauthorized use" of the bacteria. The eight-page letter, along with 195 pages of supporting documents, laid out the sequence of events that led to the doctors' research ban.
One advocate for ethical human subjects research questioned the university's decision to keep the matter in-house instead of seeking outside review.
"The time is long gone for another internal investigation," said Elizabeth Woeckner, founder and director of Citizens for Responsible Care and Research, or CIRCARE. The nonprofit group works to improve protections for human subjects in research.
Woeckner called the doctors' work on the patients – intentionally infecting them with bacteria restricted to use in lab rats only – as "the worst thing I've seen in my 12 years with CIRCARE."
This is not the first time Muizelaar has stirred controversy within university ranks.
In 2008, a neurosurgeon who has since left UC Davis sued Muizelaar, three other doctors and the university in federal court for allegedly retaliating against him after he complained about Muizelaar's ethics and competency as a surgeon.
Dr. Dongwoo John Chang, who was hired by UC Davis in 2004 as an assistant professor of neurological surgery, claimed he was getting positive performance reviews at work – until spring 2006, when he began complaining about Muizelaar's alleged "unethical and illegal activities."
Chang was suspended from the UC Davis medical staff in March 2008 for alleged "concerns raised about his patient care," court papers show. He resigned from the medical staff in July 2008.
In the lawsuit, Chang challenged Muizelaar's honesty and medical skills, citing cases in which Muizelaar allegedly failed to get proper patient consent, falsified medical records, engaged in "unethical clinical research practices" and performed unnecessary or improper surgeries.
The lawsuit shows that Chang was upset that Muizelaar did not have a California medical license. Instead he holds a "special faculty permit" – a restricted license that Chang accused his boss of abusing.
In California, only 15 doctors currently hold such special faculty permits, issued by the state medical board. The permit allows a foreign doctor who is recognized as "academically eminent" to practice medicine in California – but only at a sponsoring California medical school and its formally affiliated hospitals.
The California Business and Professions Code defines an affiliated institution as one "in which the permitholder is providing instruction."
Muizelaar, a native of the Netherlands, recently told The Bee he has seen no need to obtain a California medical license because he is "world famous" and the time-consuming process is "not necessary" for him.
In the lawsuit, Chang alleged that Muizelaar was earning thousands of dollars in extra income by serving as an on-call neurosurgeon with Mercy hospitals, which had contracted with UC Davis for neurological services.
Chang contended that Mercy hospitals did not meet the legal definition of an affiliated institution.
Bonnie Hyatt, spokeswoman for UC Davis Health System, said that Muizelaar's work at Mercy hospitals was investigated in 2008 by two outside agencies and closed that year, with no finding of wrongdoing, she said.
Muizelaar no longer works within the Mercy system, Hyatt said.
Chang, who has since joined the Illinois Neurological Institute in Rockford, did not respond to Bee requests for an interview.
In its response to the lawsuit, the university denied that Chang had been harassed or retaliated against.
Chang dropped his lawsuit last year, after he had relocated to Illinois. Court papers show he was legally representing himself at the time and having trouble scheduling visits to Sacramento for court proceedings.
In dismissing the case in February 2011, a federal magistrate judge ordered both parties to bear their own attorneys' fees and costs.
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