SACRAMENTO, Calif. -- 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.
What You Should Know About Comments on Sacbee.com
Sacbee.com is happy to provide a forum for reader interaction, discussion, feedback and reaction to our stories. However, we reserve the right to delete inappropriate comments or ban users who can't play nice. (See our full terms of service here.)
Here are some rules of the road:
â¢ Keep your comments civil. Don't insult one another or the subjects of our articles. If you think a comment violates our guidelines click the "Report Abuse" link to notify the moderators. Responding to the comment will only encourage bad behavior.
â¢ Don't use profanities, vulgarities or hate speech. This is a general interest news site. Sometimes, there are children present. Don't say anything in a way you wouldn't want your own child to hear.
â¢ Do not attack other users; focus your comments on issues, not individuals.
â¢ Stay on topic. Only post comments relevant to the article at hand.
â¢ Do not copy and paste outside material into the comment box.
â¢ Don't repeat the same comment over and over. We heard you the first time.
â¢ Do not use the commenting system for advertising. That's spam and it isn't allowed.
â¢ Don't use all capital letters. That's akin to yelling and not appreciated by the audience.
â¢ Don't flag other users' comments just because you don't agree with their point of view. Please only flag comments that violate these guidelines.
You should also know that The Sacramento Bee does not screen comments before they are posted. You are more likely to see inappropriate comments before our staff does, so we ask that you click the "Report Abuse" link to submit those comments for moderator review. You also may notify us via email at email@example.com. Note the headline on which the comment is made and tell us the profile name of the user who made the comment. Remember, comment moderation is subjective. You may find some material objectionable that we won't and vice versa.
If you submit a comment, the user name of your account will appear along with it. Users cannot remove their own comments once they have submitted them.