September 13, 2013 | Posted By John Kaplan, PhD

Today one can read the news media and regularly encounter stories about research misconduct and other questionable conduct by researchers. Having spent a career as a researcher and research ethicist I seldom see reports which shock me. There are millions of researchers making millions of research reports and these things happen. However the story of two neurosurgeons from the University of California at Davis School of Medicine was so egregious that it shocked even me.  Dr. J. Paul Muizelaar and Dr. Rudolph J. Schot so blatantly disregarded the ethical underpinnings for the conduct of research on human subjects that their only defense was that their actions did not constitute research. Much of my information on this incident comes from the excellent articles reported by Marjie Lundstrom of the Sacramento Bee as well as the insights of their editorial staff.

Drs. Muizelaar and Schot were senior academic neurosurgeons who have recently resigned from their positions at University of California at Davis School of Medicine as a result of the fallout from this incident and the subsequent investigation.  The two neurosurgeons intentionally caused infections in the brains with bowel bacteria, Enterobacter aerogenes, in patients with glioblastoma, a brain cancer which is nearly always fatal. It was their contention that these infections would stimulate the immune system which would, in turn, battle the tumor. All patients died, two within weeks while the other lasted over a year.

The medical profession operates under a rigorous of protocols designed to protect human subjects from dangerous research including research which has inadequate scientific basis. This nearly always requires that preliminary work supporting the concept be completed in animal models. These protections extend to the terminally ill who might consent to anything if their physicians suggest it could help them. All three of these patients provided consent but there are several problems here. One problem is that patients can be unduly influenced by their trusted physicians, especially under duress during seemingly hopeless situations. This has been suggested as a reason that physicians should not pursue research protocols on their own patients. Another is that these physicians had not received the necessary institutional approvals of the protocol and the consent procedures to even be allowed to ask for approval. Each institution engaging in human studies uses an Institutional review board (IRB)to review and approve such protocols.

Prior to these incidents the investigators had clearly recognized that the studies constituted research. They had sought approval from the Food and Drug Administration. Not only was their procedure not approved by the FDA but they were told not to conduct to conduct the procedures in humans without having conducted such studies in animals. The IRB had previously told these neurosurgeons not to do these procedures and was later bypassed by the investigators. They began but did not complete animal studies. They did the procedure in patients anyway. By the way, they have attempted  to patent this process they call “probiotic intracranial therapy” so financial benefits are possible.

They are now trying to defend themselves by claiming that these procedures were not research but constituted innovative patient care. It is difficult to justify what these physician physicians did. I have a hard time explaining what they did any other way than hubris, an unrestrained arrogance where they felt they knew better than everyone else, whereby they were free to bypass the safeguards designed to protect people from unethical research. I think it is difficult to classify this as anything other than assault. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

1 comments | Topics: Ethics in Clinical Trials , Research Ethics



GastonGary wrote on 11/11/13 3:05 AM

A Great review on Hubris and Biomedical Research.

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