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Saturday, December 7th 2013

Novel Treatments

The history and evolution of novel clinical research is interesting. The old ideal, “Don’t think; try is, perhaps rightly tempered by the new ideal of not just the informed and consented patient but protected patient. Such is interesting considering our move, otherwise, away from paternalism.

The development of the smallpox vaccine or the first artificial heart would have never happened today as is. Of course, neither would these horrific syphillis experiments hopefully.

Not to argue that IRBs and government agencies have made clinical research too burdensome and are hampering progress.

It’s just that a focus and regulations beyond guaranteeing informed consent seems counter to the way the rest of medicine is moving.

I’m not sure many are arguing three glioblastoma multiforme patients of Drs. Muizelaar and Schrot were at UC-Davis were ill informed. But the treatments they undertook for those patients, without approval, have cost both men their jobs. Dr. Muizelaar was in fact chairman of Neurosurgery at UC Davis prior to this scandal bringing him down.

I’ve covered this previously. But with both men resigning earlier this year its worth bringing up again now that we have some resolution.

Two UC Davis neurosurgeons who intentionally infected three brain-cancer patients with bowel bacteria have resigned their posts after the university found they had “deliberately circumvented” internal policies, “defied directives” from top leaders and sidestepped federal regulations, according to newly released university documents.


The most contentious issue between the doctors and the university – and even within the university – was this: Were the surgeons performing research? Or were they providing “innovative care?”

Research on humans is tightly controlled in the United States and, according to federal regulations and university policy, must undergo a rigorous approval process to ensure that participants are protected from harm. Innovative treatment, more commonly known as compassionate care, gives a doctor more latitude in offering nonstandard care to a single patient where evidence of safety or success is limited.


Muizelaar and Schrot called their novel approach “probiotic intracranial therapy,” or the introduction of live bowel bacteria, Enterobacter aerogenes, directly into their patients’ brains or bone flaps. The doctors theorized that an infection might stimulate the patients’ immune systems and prolong their lives.

The first patient lived about 5 1/2 weeks. The second survived another year, an outcome that buoyed the doctors and seemed to bolster their theory, they said.

The institutional trouble began in March 2011, when a newly diagnosed third patient developed sepsis, became unresponsive and died two weeks after being deliberately infected. The university’s first internal investigation soon followed.

What they did was highly unethical and dangerous.

But I have trouble with this paternalism later in the article,

“I think sometimes surgeons and doctors can get caught up in the enthusiasm for what they really believe is going to work,” said Caplan, head of medical ethics at New York University’s Langone Medical Center. “That is exactly why we have FDA oversight and approval and the research ethics requirement we do.

“Every time somebody dies or is injured or we have to recall a product, what we find ourselves saying is, there is no short-cut to innovation,” he said. “Finding the truth is a long, slow, arduous process.”

Informed consent for novel treatments can be difficult. “Informed” consent for proven standard of care is difficult. But maybe the focus should be on that and not necessarily on impeding access to even highly dangerous and unproven treatments.