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Bizarre Episode Raises Questions About Research Ethics

Posted Aug 06 2012 2:13pm

Two prominent neurosurgeons at UC Davis Medical Center reportedly performed a bizarre experiment on three terminally ill patients last fall. According to an ABC News article from July 27, 2012 (cited below), Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot injected live bacteria into the head wounds of three patients. Each was suffering from glioblastoma, a malignant tumor of the supportive tissues of the brain.

The surgeons believed that infections arising from the bacteria would somehow attack the patients’ tumors, allowing them to live longer. All three patients gave their consent, though the research was performed without university authorization. Two patients died of sepsis shortly after the treatment was administered. The university has ordered the surgeons to cease and desist, and has barred them from any further human research endeavors.

In an interview with the Sacramento Bee, one of the doctors said, “We certainly didn’t blatantly trample any rules.” The surgeons insisted that the procedure was simply an unusual treatment, not actual research. The university believes otherwise. A review is underway, which could lead to problems with future research funding by the Food and Drug Administration.

A few comments:

1) There is sometimes a fine line between unusual or innovative treatments and research. A truly innovative treatment for cancer should be approved by a hospital or university Institutional Review Board (IRB). This protects vulnerable research subjects, such as the patients in this case.

2) The lack of IRB review in this case means such research may forever be tainted. What if the surgeons’ idea had actually worked? The fact that it was done without oversight casts doubt on any results, successful or not.

3) It is difficult to obtain truly informed consent from terminal cancer patients. They may be so desperate for a “cure” that they may consent to inappropriate or dangerous treatments. Think, for example, of the ongoing popularity of travel to Mexico for the treatment of various cancers with laetrile, despite its toxicity and lack of benefit.

The primary mandate of medical ethics still holds true: first of all, do no harm.

 

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