J. D. Heyes
September 6, 2013
Sometimes, things happen that are so shocking that not only do they defy belief, but they defy explanation. For instance, why a pair of neurosurgeons with decades of education and training would throw it all away on a goofy, if not novel, medical procedure that had no prior track record.
According to CBS Sacramento, the two California neurosurgeons infected brain-cancer patients with bowel bacteria “in an effort to save their lives.” In light of the treatment revelations, the two surgeons – Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot – have since resigned their posts at the University of California-Davis “after officials concluded their actions violated the school’s code of conduct.”
More from The Associated Press:
[The surgeons] had the permission of the three patients to try the injections, but university officials concluded they failed to get the required prior approval from either the school or the federal Food and Drug Administration for such an experimental treatment that had not been tested on animals.
Investigations, then came resignations
All three of the patients – a middle-aged man and two middle-aged women – had been diagnosed with glioblastoma, which is a potent, highly malignant brain tumor. The surgeons said they had hoped that injecting the patients with some live bowel bacteria would stimulate their immune systems and perhaps prolong their lives.
But that didn’t happen. The first patient developed sepsis – illness caused by serious infection – and died within two weeks. The second died within a month; the third lived for more than a year, which gave the surgeons hope that perhaps the treatment was working.
After the first patient died, the university launched an investigation. When the Sacramento Bee newspaper reported on the treatments in July 2012, a second investigation was launched, and it resulted in the surgeons’ resignations.
University officials and investigators came to the conclusion that Muizelaar and Schrot “deliberately circumvented” the schools’ internal ethics policies, “defied directives” from top leaders and dodged federal rules.
“Investigators I appointed heard from some witnesses that there is perception that compliance with university policies and external regulatory requirements is not a universally held value,” said Ralph J. Hexter, the school’s provost and executive vice chancellor.
As a result of the investigation, Dr. Claire Pomeroy, dean of the university’s school of medicine, also resigned. She left her post last June.
‘I would do this for myself’
More from the AP:
Muizelaar, who headed the university’s neurosurgery department, also left in June. Schrot plans to leave at the end of the month.
The doctors told the Bee they weren’t trying to do unapproved research or create a treatment they could profit from. They said they only wanted to give their patients a last-ditch chance at survival, Muizelaar adding that the treatment had been suggested by a colleague.
Said Muizelaar: “I was simply thinking that I could help patients. My whole medical practice is guided by actually only one principle, namely: What would I do for my mother, my son, myself?”
Despite the patients’ giving their permission, two of the families sued.
From the Bee:
Two of the families later settled claims against the university for $150,000 and $675,000, creating a new tangle in the controversy that has raised complex questions about the nature of consent, what constitutes research – and how to safeguard vulnerable patients.
The two doctors said that the internal investigations into their conduct were both biased and incomplete.
“I lost confidence, if you will, in the ability of the university administration to fairly handle it,” Schrot told the paper.
The California Department of Health has also piled on. It has fined the university $50,000 for the surgeons’ work.