The Sacramento Bee recently reported that two
UC Davis
neurosurgeons who intentionally infected three glioblastoma patients
with bowel bacteria have resigned their posts after the university found
they had "deliberately circumvented" internal policies, "defied
directives" from top leaders and sidestepped federal regulations,
according to newly released university documents.
 |
Neurosurgeon J. Paul Muizelaar, MD |
Dr. J. Paul Muizelaar, 66, the former head of the neurosurgery
department, and his colleague, Dr. Rudolph J. Schrot, violated the
university's faculty code of conduct. All three patients consented to
the procedures 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.
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy
Muizelaar and Schrot called their novel approach "probiotic intracranial therapy," or the introduction of live bowel bacteria,
Enterobacter aerogenes,
directly into their patients' brains or bone flaps. The doctors
theorized that an infection might stimulate the patients' immune systems
and prolong their lives. The first patient lived about 5 1/2
weeks. The second survived another year, an outcome that buoyed the
doctors and seemed to bolster their theory, they said. The institutional trouble began in March 2011, when a newly diagnosed
third patient developed sepsis, became unresponsive and died two weeks
after being deliberately infected. The university's first internal
investigation soon followed.
Muizelaar and Schrot did not complete a study on rats before they began
treating the three human patients, despite an FDA directive in 2008 that
"animal studies will be necessary prior to entering into the clinic
with your proposed therapy," according to an email to Schrot from an FDA
official. When asked by a compliance investigator why animal trials
were not done first, Schrot allegedly responded that such testing would
take "10 years … his entire career," one internal review states. The
investigator found Schrot's "eagerness to proceed" to be concerning and
his actions "reckless."
Muizelaar, one of the highest paid employees in the
University of California system, stepped down effective June 27. He earned more than $907,000 last year, the 33rd-highest gross pay in the
UC system. Schrot, 45, an associate professor who made about $512,000 last year, will leave his post at the end of August. Both
doctors have sharply criticized the findings, characterizing the
internal investigations as biased and incomplete. The surgeons maintain they were acting in the
best interests of their desperately ill patients, whose prognoses for
survival were poor. Both doctors opted
not to appeal the university's findings because they determined it would
be fruitless."I lost confidence, if you will, in the ability of the university
administration to fairly handle it," Schrot said Friday in the office of
his Sacramento attorney.
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy
One colleague, Dr. David Asmuth, an infectious disease specialist who
co-chaired an oversight committee for university research, called the
surgeons' procedure "the worst case of human subjects research he had
ever seen."
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy
"I
was simply thinking that I could help patients," Muizelaar said. "My
whole medical practice is guided by actually only one principle, namely:
What would I do for my mother, my son, myself?"
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy
Read more here: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html#storylink=cpy