Two University of California, Davis doctors have been banned from performing human experiments after they allegedly experimented on three patients without university permission last fall.
The Huffington Post reports that the two neurosurgeons were ordered by the university to “immediately cease and desist” from any research involving humans last fall after they introduced bacteria into the open head wounds of three terminally ill patients, believing that the bacteria would help save their lives.
While documents acquired by The Sacramento Bee show that the surgeons obtained consent from the patients before they introduced the bacteria, the university did not give them permission to proceed. As a result of the experiment, two of the patients developed sepsis and died.
The doctors involved were J. Paul Muizelaar, 65 and Rudolph Schrot, 44. Muizelaar is the university’s chair of the Department of Neurological Surgery, while Schrot has worked under Muizelaar as an assistant professor and neurosurgeon for 13 years. Despite the university’s decision, Muizelaar doesn’t believe he did anything wrong. He stated:
“And I understand it…there are people who blatantly break the rules that endanger all of their research programs. We certainly didn’t blatantly trample any rules.”
Patricia Backlar, an Oregon bioethicist who served on former President Bill Clinton’s national bioethics advisory commission, stated that the doctors’ unauthorized experiments were “really distressing.” Barklar went on to say:
“UC Davis is a very respectable school, but even the best places have trouble…These men have put that school in jeopardy.”
After learning more about the doctors’ unusual work, UC Davis officials moved swiftly to launch an internal investigation, which lasted six months. The university’s vice-chancellor for research notified the FDA of “serious and continuing noncompliance” by both surgeons in an eight-page letter, which included 195 pages of exhibits. The vice-chancellor, Harris A. Lewin, claimed that both Muizelaar and Schrot sidestepped procedures in their mission to introduce bacteria into the head wounds of live patients.
Lewin explained his decision to self-report to the FDA, saying:
“We really take these matters very seriously. We pursued this very aggressively and very vigilantly to ensure that we were complying with all regulations, so that we can continue to put protection of human subjects as paramount. You can understand why. Because if you don’t do so, all your funding for federal research can be in jeopardy.”
Mercury News reports that the first patient in the unauthorized human experiment died six weeks later after the tumor progressed and the patient contracted sepsis. The second patient was still alive when Lewin wrote his letter to the FDA, but suffered a wound infection and was given antibiotics after being intentionally infected (this patient has also since died). The third patient developed sepsis and meningitis soon after surgery and infection and died.
A FDA spokesman declined to comment about any investigation with UC Davis involving J. Paul Muizelaar and Rudolph Schrot.