Are a few animal studies and a handful of human case reports enough to let physicians skirt institutional review boards?
Two neurosurgeons in California did just that when they used Enterobacter aerogenes to infect the surgical wounds of three terminally ill glioblastoma patients. Two of the patients died from the infections.
Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot of the University of California, Davis, said their attempt to stimulate their patients’ immune response was not research but “a one-time procedure” – exempt from review, according to a report in the Sacramento Bee.
Now both are banned from human research projects and the institutional review board is the subject of its own investigation.
For an account of the scientific thinking behind the deployment of bacteria in these patients and of ongoing efforts to develop immunotherapies against cancer, see the journal Nature (2012 July 27 [doi:10.1038/nature.2012.11080]).