Saturday, July 28, 2012

2 UC Davis neurosurgeons accused of experimental surgery are banned from human research


sacbee | A prominent UC Davis neurosurgeon was banned from performing medical research on humans after he and an underling were accused of experimenting on dying brain cancer patients without university permission, The Bee has learned.

Dr. J. Paul Muizelaar, who earns more than $800,000 a year as chairman of the department of neurological surgery, was ordered last fall to "immediately cease and desist" from any research involving human subjects, according to documents obtained by The Bee.

Also banned was the colleague, Dr. Rudolph J. Schrot, an assistant professor and neurosurgeon who has worked under Muizelaar the past 13 years.

The university has admitted to the federal government that the surgeons' actions amounted to "serious and continuing noncompliance" with federal regulations.

Documents show the surgeons got 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. Two of the patients developed sepsis and died, the university later determined.

The actions – described by two prominent bioethicists as "astonishing," and a "major penalty" for the school – threaten both the doctors' professional careers and the university's reputation and federal-funding status.

"This is really distressing" said Patricia Backlar, an Oregon bioethicist who served on former President Bill Clinton's national bioethics advisory commission.

"UC Davis is a very respectable school, but even the best places have trouble," Backlar said. " … These men have put that school in jeopardy."

Research on both humans and animals is tightly controlled in the United States and, according to federal regulations and university policy, must undergo a rigorous approval process to ensure that subjects are protected.

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