Innovative or Experimental? Brain Surgeon Tests Rumored Treatment on Three Patients

Under what circumstances is it acceptable for doctors to treat a patient, particularly one with a very poor prognosis, with an untested or experimental treatment? Dr. Paul Muizelaar confronted this problem firsthand a few years ago, when he performed three surgeries based on a long-lasting hospital rumor.  The rumor was that for a certain type of brain tumor, called glioblatoma multiforme, an infection of the wound site during surgery could actually extend a patient’s life significantly. A few studies on the method led to divergent results.  At present, there is no scientific consensus on the procedure’s effectiveness.

Despite this lack of data and previous failure to secure funding for animal research on the topic, Dr. Muizelaar first tested this treatment on a friend of his who was diagnosed with the deadly tumor and had exhausted all standard treatments. The treatment would include surgery on the tumor, during which Muizelaar would intentionally infect the brain with a type of bacteria found in fecal matter. Muizelaar had been given limited approval to conduct the surgery from the hospital’s review board, as it could probably be classified as “innovative treatment” rather than human research. The outcome was just enough to give some hope, and so Muizelaar quickly wanted to try it on another patient. This led to a second surgery, on another patient who had already exhausted the usual treatment options.  The hospital’s administration was much more hesitant about this second surgery. Muizelaar was told that if he planned to do any more of these surgeries he should submit a formal application to the FDA and hospital. However, Muizelaar performed one more surgery. He said that at the time it didn’t even occur to him that he wasn’t following those instructions, and he was just trying to treat the patient. This last patient was newly diagnosed, hadn’t had any standard treatments yet, and ended up passing away within a few weeks of the surgery.

Muizelaar was widely scrutinized for these surgeries and was eventually forced to retire from his high-ranking position at the hospital. Did Dr. Muizelaar go too far? He claims that his goal was only to help patients and that these patients had almost no other hope for survival. Any formal research progress in this area would have taken many years after these patients’ deaths. Should doctors be able to test ideas on patients without following the usual protocols for human research? Is this type of regulation stifling innovation or protecting patients from dangerous experimentation?

Source: http://www.newyorker.com/magazine/2015/12/07/bacteria-on-the-brain?intcid=mod-most-popular

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