Two neurosurgeons at the University of California, Davis, (UCD) have been suspended from human preclinical research for carrying out experiments on terminal brain cancer patients that were unauthorized by the university and by the US Food and Drug Administration (FDA).
J. Paul Muizelaar, chair of the UCD Health System's Department of Neurosurgery, and assistant professor Rudolph Schrot treated the open brain wounds of three patients with malignant gliomas with a culture of the gram negative Enterobacter aerogenes bacteria in the hopes that the postoperative infection would jumpstart an immune reaction that would fight off the cancer and extend the survival of the patients.
The researchers first considered pursuing the experimental treatment in a terminally ill patient in 2008, but were denied approval by the FDA, which stated that animal studies were necessary "prior to entering into the clinic with your proposed therapy," according to a letter sent to the FDA by a university official in October 2011 detailing the researchers’ actions. Despite this denial, the researchers went ahead with the experimental procedure on three terminally ill patients between October 2010 and March 2011.
The third patient died of sepsis shortly after the procedure, prompting the university’s institutional review board (IRB) to order the researchers to stop their experimental probiotic treatments, , and to launch a 6-month investigation into the matter, The Sacramento Bee reported. Both researchers have since been ordered to stop enrolling new subjects in any research in which they serve as principal or co-principal investigators.