The Chronicle of Higher Education. August 26, 2013. Two prominent neurosurgeons at the University of California at Davis whointentionally infected three brain-cancer patients with bowel bacteria have resigned their posts after university investigations found they had “deliberately circumvented” internal policies and sidestepped federal regulations, The Sacramento Bee reported.
Both of the neurosurgeons—J. Paul Muizelaar and Rudolph J. Schrot—have sharply criticized the findings, characterizing the university’s investigations as biased and incomplete. They told the Bee that they had opted not to appeal the findings because they believed an appeal would be fruitless.
The surgeons maintain they were acting in the best interests of the three patients, who suffered from a highly malignant brain tumor, known as glioblastoma, for which the median survival time is less than 15 months. Dr. Muizelaar and Dr. Schrot introduced live bowel bacteria directly into the patients’ brains or bone flap, theorizing that an infection might stimulate the patients’ immune systems and prolong their lives. All three patients had consented to the procedures, which were performed in 2010 and 2011. Two of the patients died within weeks of their surgeries, while the other survived more than a year after being infected.
The doctors also maintain that they were not conducting research but providing “innovative care,” which is not subject to the same strict standards that research involving human subjects must meet. Still, the patient deaths triggered an investigation by the university’s internal review board, which in September 2011 concluded that they had conducted improper research on human subjects without obtaining the approvals required by university policy and federal regulations. At the time, both were banned from performing further medical research involving human subjects.
Davis’s chancellor, Linda P.B. Katehi, ordered additional investigations after theBee first published a report about the surgeons’ controversial work, in July 2012. Since then, the doctors’ conduct and the safety and quality of patient care at the university’s medical center have been the subject of at least eight internal and external investigations.
The university recently released to the Bee nearly 1,000 pages of documents detailing its internal probes. According to those documents, the university concluded that Dr. Muizelaar and Dr. Schrot had stepped well outside of regulatory and ethical bounds and had violated the faculty code of conduct.
The findings also identified lapses by staff members and administrators, saying that compliance problems may extend beyond the neurosurgeons’ case. In a letter this month to Chancellor Katehi, the university’s provost concluded that “additional safeguards must be developed and implemented to further protect research subjects and patients.”