Neurosurgeons banned from human research for giving infectious bacteria to brain tumor patientsS

UC Davis neurosurgeons J. Paul Muizelaar and Rudolph J. Schrot have been barred from performing human medical research, after being accused of experimenting on terminally ill brain cancer patients without University permission. But the researchers continue to insist that the accusations are misleading.

According to the Sacramento Bee:

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 postoperative infections might prolong their lives. Two of the patients developed sepsis and died, the university later determined.

The actions – described by two prominent bioethicists as "astonishing," and a "major penalty" for the school – threaten both the doctors' professional careers and the university's reputation and federal-funding status.

"This is really distressing" said Patricia Backlar, an Oregon bioethicist who served on former President Bill Clinton's national bioethics advisory commission.

Muizelaar has since described the research ban as an "overreaction" on the university's part, telling the Bee last week that he and Schrot were under the impression that the FDA had given them permission to conduct any treatments they thought would be "beneficial to the patients."

Be that as it may, Muizelaar says he understands why the ban was instituted. "There are people who blatantly break the rules that endanger all of their research programs. We certainly didn't blatantly trample any rules."

The situation has raised important questions surrounding medical ethics and the bureaucratic intricacies of conducting cutting edge research. The policies and regulations that Muizelaar and Schrot have been accused of circumventing are in place to protect research subjects, and their violation can trigger audits from the US FDA that can cost research institutions tens of millions of dollars. The FDA has yet to comment on the case (which was self-reported by the University last year), or whether it would ultimately give rise to such an audit. In the meantime, Muizelaar remains the "Julian R. Youmans endowed chairman" of the University's neurological surgery department — a position he was honored with this spring, after he was ordered to "immediately cease and disist" from any research involving human subjects. It all causes you to wonder: Just how serious this infringement, really?

You'll find extensive coverage of the case in yesterday's edition of the Sacramento Bee.

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