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Terminally ill patients used in radical experiments

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Jul 23, 2012, 11:36:23 PM7/23/12
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Terminally ill patients used in radical experiments
July 24, 2012 12:00AM
A PROMINENT neurosurgeon at the University of California, Davis has
been banned from performing medical research on humans after he and a
colleague were accused of experimenting on dying brain cancer patients
without university permission.
Dr J Paul Muizelaar, who earns more than $800,000 a year as chairman
of the UC, Davis's department of neurological surgery, was ordered
last to ``immediately cease and desist'' from any research involving
human subjects, according to documents obtained by local newspaper The
Sacramento Bee.
Also banned was Dr Rudolph J Schrot, an assistant professor and
neurosurgeon who has worked under Muizelaar the past 13 years.
Documents show the surgeons got the consent of three terminally ill
patients with malignant brain tumors to introduce bacteria into their
open head wounds, under the theory that post-operative infections
might prolong their lives. Two of the patients developed sepsis and
died, the university later determined.
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Research on humans and animals is tightly controlled in the US and
must undergo a rigorous approval process to ensure that subjects are
protected.
The National Institutes of Health also plays a role in protecting
human subjects by potentially withholding coveted research money from
individuals or institutions. Among medical schools, UC Davis ranks
36th in the nation in NIH funding for medical research at more than
$130 million in 2011.
Muizelaar, 65, who has been a department chairman at the School of
Medicine since 1997, said last week that he and Schrot believed the
FDA gave its permission early on, if the doctors thought the treatment
was ``beneficial to the patients.'' He described the research ban as
an ``overreaction'' by the university.
``There are people who blatantly break the rules that endanger all of
their research programs. We certainly didn't blatantly trample any
rules,'' he said.
Schrot said: ``the determination of 'serious and repeated
noncompliance' is misleading.''
Despite the disciplinary action imposed almost a year ago, Muizelaar
was honored this year with an additional academic role at UC Davis. He
was named the first holder of the Julian R. Youmans endowed chair in
the department of neurological surgery.
He said he plans to funnel endowment dollars into further research on
the procedure that led to the ban.
``If I come down with a glioblastoma, I will demand that it be done on
myself,'' Muizelaar s aid.
The divergent views illustrate the tension that exists at research
institutions between protecting human subjects and developing cutting-
edge cures.
The controversy erupted over a project known as Probiotic Intracranial
Therapy for Malignant Glioma.
The surgeons were intrigued by clinical trials showing promising but
unproven results in patients suffering from glioblastoma, the most
common and most deadly type of malign ant brain tumor. For these
patients, median survival is only about 15 months from diagnosis.
However, Muizelaar and Schrot were aware of medical literature that
``seems to suggest'' that patients who had post operative infections
lived longer. Muizelaar said he ``inherited'' two glioblastoma
patients who had unintended infections who went on to live 15 and even
20 years with the deadly disease.
In 2008, the doctors proposed treating a glioblastoma patient with
bacteria applied to an open wound to ``attack the tumour,'' then later
withholding antibiotics and letting the bacteria do its work.
Schrot contacted the FDA but ultimately was told that animal studies
were needed first. So the doctors continued with preclinical work,
arranging for a rat study.
From October 2010 to March 2011, the physicians did three procedures
on humans with malignant brain tumors, surgically introducing
probiotics into their open head wounds.
University documents show that the physicians believed they had been
given the go-ahead for all three surgeries, but officials later
determined that they had been misinformed or were misunderstood by the
doctors.
Muizelaar and Schrot stressed that all three patients, in consultation
with their families, gave their consent.
The patients' outcomes varied dramatically.
Patient 1 died six weeks later after the tumour progressed. The
university later determined that the patient also had developed
sepsis, a life-threatening illness in which the body responds severely
to bacteria or germs.
Patient 2, who underwent t he procedure in 2010, was still alive in
October 2011. The patient was described as having a reduction in the
brain tumor but also suffered a wound infection and was given
antibiotics 10 months after being intentionally infected. The patient
has since died.
Patient who underwent surgery in 2011, soon developed sepsis and
meningitis and died.
The same day Patient 3 ``suddenly and precipitously deteriorated''
Muizelaar and Schrot were seeking per mission from an ethics committee
to infect five more patients.

Arthur Caplan, director of medical ethics at New York University's
Langone Medical Centre, said that desperate people are especially
vulnerable and need added protections.
``If you're dying, you're kind of like reaching out to anything that
anybody throws in front of you,'' said Caplan.
``They're not able to think straight because they're at death's
door.''
Schrot said he now realises that federal regulations are complex, and
that ` `all the appropriate regulatory processes were not followed''.
Muizelaar said he and Schrot had no financial incentive or underlying
motive for the research.
``This treatment - we did it purely to save some patients,'' he said.
``This is not something we can take a patent on. We won't get a dime
for it.''



http://m.theaustralian.com.au/higher-education/terminally-ill-patients-used-in-radical-experiments/story-e6frgcjx-1226432743081
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