UC Davis chancellor orders review of university doctors' actions

07/25/2012 12:00 AM

10/08/2014 10:37 AM

UC Davis Chancellor Linda P.B. Katehi has ordered a top campus official to conduct a "comprehensive review" of accusations that two university neurosurgeons conducted unauthorized research on dying brain cancer patients, as reported in Sunday's Bee.

Ralph J. Hexter, the provost and executive vice chancellor, will lead another investigation into the actions of Dr. J. Paul Muizelaar, the longtime chairman of the department of neurological surgery, and his colleague, Dr. Rudolph J. Schrot, according to a university spokesman.

The Bee reported Sunday that both doctors were banned last fall from performing any medical research on humans. A six-month internal investigation by a campus-wide oversight board determined that the surgeons had performed experimental procedures on terminally ill brain cancer patients without university permission.

The doctors did get the consent of the patients, documents show.

"It's clear there are issues that need to be looked at rigorously," UC Davis spokesman Barry Shiller said Tuesday.

The surgeons introduced bacteria into open head wounds of three patients with malignant brain tumors, testing a theory that postoperative infections might prolong their lives. Two of the patients developed sepsis and died, the university's oversight committee ultimately determined.

Both surgeons told The Bee last week they believed they were performing innovative treatments, not research. They also said they believed they had been given the go-ahead.

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

Alleged violations could trigger an audit by the U.S. Food and Drug Administration – and also place federal research money in jeopardy.

Historically, other major academic institutions have had millions of dollars in federal research funding suspended over accusations of ethical misconduct involving human research subjects.

Shiller said Tuesday that Provost Hexter has direct authority over all campus academic affairs, the equivalent of a chief operating officer.

Dr. Claire Pomeroy, dean of the UC Davis School of Medicine, where the neurosurgeons work, reports to the provost.

Shiller said that Chancellor Katehi, who is out of the country, asked the provost to launch another investigation upon "recognizing the scope of the issues that are on the table."

"She's charging him with doing a comprehensive review of what happened," he said.

Shiller said he expects the review to be under way "very quickly" and that it is not expected to drag on for months.

Muizelaar has headed the department of neurological surgery since 1997. Schrot, an assistant professor, has worked for Muizelaar the past 13 years.

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