By Amy Standen
As reported initially by the Sacramento Bee, Paul J. Muizelaar, who chairs the UC Davis Department of Neurological Surgery, and Rudolph J. Schrot, performed an experimental treatment on three patients between 2010 and 2011.
An internal letter (PDF) from UC Davis’s Vice Chancellor for Research to the Food and Drug Administration reports that the work was done without going through UC Davis’s Institutional Review Board, which oversees the university’s experimental treatments and research.
The treatment involved applying bacteria to open head wounds on patients, in the hope of provoking the body's natural immune response. Cancer researchers have been cautiously optimistic that such a procedure might prolong life in patients suffering from glioblastoma, an aggressive brain tumor.
All three patients died, at least one of them from a blood infection brought on by the infection.
The case poses some tough questions, according to Jeffrey Burack, who teaches ethics at UC Berkeley's School of Public Health.
In all three cases, the patients were dying, and under the care of Muizelaar and Scrot. They and their families knew the treatment was experimental, and at least one patient had specifically requested it.
In explaining their plans to the university, Muizelaar and Scrot maintained that the treatment qualified as “innovative care,” “not associated with research aims,” according to the Vice Chancellor’s letter.
But the line between treatment and experimentation is not always so clear, says Burack.
In cases where a therapy is considered emergency and potentially life-saving, Burack says, doctors have more latitude to perform procedures without undergoing extensive review processes.
But when the treatment also happens to be a research interest of the doctor, says Burack, “that puts the patient in a particularly vulnerable position.”
Researchers, Burack says, want to experiment. They want to know whether a treatment works.
That zeal, says Burack, may cloud a physician’s ability to objectively explain the risks to his or her patients.
This, says Burack, is why institutional review boards exist, to provide a third party that can review the case more objectively and advise a course of action that’s best for the patient.
“Part of an [institutional review board]'s charge,” he says, “isn't just to say ‘is the consent ok?’ but also ‘Is there good enough evidence?’ ‘Does the expected benefit to the patient seem balanced?’ ‘Is everything reasonable being done?’”
According to the University’s report, Muizelaar and Schrot acted independently, without oversight of the review board.
A spokeswoman from the FDA declined to comment on whether the agency will take punitive action against the University. According to an National Institutes of Health spokesperson, Muizelaar and Schrot did not use NIH funding to perform the research, and that any external investigation would therefore fall to the FDA.