Thursday, September 6, 2012

Feds initiate probe of UC Davis brain cancer cases - Sacramento Bee

Federal officials have initiated an investigation into the care provided to three University of California, Davis brain cancer patients who died after receiving experimental treatment.

The university confirmed to the Sacramento Bee (http://sacb.ee/OSh0BZ) this week that the federal Centers for Medicare and Medicaid Services has asked the state to investigate the cases. The state Department of Public Health is expected to release its findings in about a month.

The university has accused two neurosurgeons, J. Paul Muizelaar and Rudolph Schrot, of failing to get proper university and federal government approval before introducing bacteria into open head wounds on the patients in 2010 and 2011. The doctors were trying to see if infections would stimulate an immune response against the cancer.

According to university documents reviewed by the newspaper: One patient died of sepsis, a severe reaction to bacteria and germs, six weeks after the treatment; another patient who underwent surgery in 2011 died soon after developing sepsis and meningitis; a third suffered a wound infection and died more than a year later.

A university official told the U.S. Food and Drug Administration that the researchers sidestepped the necessary procedures for such treatment.

The case shocked some bioethicists.

""The most important thing here is, you cannot treat people with a completely unapproved drug," R. Alto Charo, bioethics professor at the University of Wisconsin, told the newspaper.

Muizelaar and Schrot did not immediately respond to email messages from The Associated Press seeking comment.

They told the Sacramento Bee in June that university claims about their compliance with research rules were exaggerated. Muizelaar told the newspaper he hopes to see further research on the bacterial therapy.

"We certainly didn't blatantly trample any rules," he said.

State and federal officials told the Sacramento Bee they could not comment on the probe because the investigation was ongoing. It was not immediately clear whether the FDA is investigating the case.

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