Experiment vs. innovative treatment in bacterial transplants

By Nicholson Price

There’s a fascinating and tragic story coming to its conclusion at UC Davis, which points at the fine line between clinical innovation and experimental treatment.  Two neurosurgeons just resigned, following the resignation of the med school’s dean last year.  The neurosurgeons, going off anecdotal evidence that some patients with deadly glioblastomas lived significantly longer when they accidentally acquired post-surgery infections, had deliberately infected three patients with live Enterobacter aerogenes, a bowel bacterium, and withheld antibiotics.  All three patients died, two of untreated sepsis.  It seems quite clear that the doctors were trying to do their best to help the patients; but they also appear to have circumvented procedures and rules to do so.  The consent form was only 300 words, though it included language that “[t]here is no proof that such treatment (for brain cancer) might be beneficial, nor are there animal data to support it” and that resulting harms might include “paralysis, inability to speak or understand speech, inability to swallow, vegetative state, coma or death.”  The Sacramento Bee has an excellent series of articles here.

One does wonder: if it had worked, would the reaction have been the same, or would the surgeons have been hailed as innovators and heroes?  In a similar case also involving bowel bacteria, fecal transplantation to treat Clostridium difficile is becoming much more accepted (see paywalled NEJM article or free Scientific American summary).  But as far as I can tell, the impetus for systematic experimental study of fecal transplants came from a long series of successful case studies in the course of treatment, not clinical trials, and I can’t see evidence that most or all of those case studies involved governmental or IRB approval.  Once reports of fecal transplants became more widespread (especially once that NEJM article came out on the topic), FDA decided it would regulate the transplants under Investigational New Drug requirements.  But the agency has since backed off its stance, and doctors are currently free to perform fecal transplants so long as they acquire informed consent.  So this type of bacterial transplant remains innovative treatment, not experimentation requiring FDA or IRB approval.

I’m not an expert on experimental treatment.  But the strong juxtaposition between the two treatments, one of which received tremendous censure and the other of which is accepted as a promising new treatment, is striking.  What do you think?  Am I missing some big difference-in-kind between these two situations, or is just differences in degree (less consent, less transparency, riskier)?  Or maybe success vs. failure is the most important thing – which would be an unfortunate if not particularly surprising conclusion.

W. Nicholson Price

Nicholson Price is an Assistant Professor of Law at the University of Michigan Law School. Previously, he taught law at the University of New Hampshire. He holds a PhD in Biological Sciences and a JD, both from Columbia, and an AB from Harvard. He clerked for Judge Carlos T. Bea on the Ninth Circuit, and was then appointed as an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. Nicholson teaches patents and health law and studies life science innovation, including big data and artificial intelligence in medicine. He recommends reading Bujold, Jemisin, and Older. His work has appeared in Nature, Science, Nature Biotechnology, the Michigan Law Review, and elsewhere. Nicholson is cofounder of Regulation and Innovation in the Biosciences, co-chair of the Junior IP Scholars Association, and a Core Partner at the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law.

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