Neurosurgeons at UC Davis censured after trying out probiotic treatments on brain cancer patients

The Sacramento Bee is reporting on a complicated story about last-ditch treatments and the ethics of human experimentation.

Glioblastomas are incredibly deadly brain cancers that usually kill the people diagnosed with them within 15 months. Two neurosurgeons at UC Davis ran across anecdotal evidence suggesting that glioblastoma patients who accidentally picked up infections after surgery sometimes lived much longer — one of the surgeons claims that a patient he knew of survived another 20 years.

Eventually, the two surgeons tried infecting three glioblastoma patients intentionally, withholding antibiotics in the hopes that the body's immune system would attack both the infection and the tumor and lead to a longer life. In order to do this, they classified their work as a "treatment" rather than an "experiment", a decision that allowed them to operate without FDA approval or oversight from the ethics review board at UC Davis. All three patients died, two of them from untreated sepsis — that is, a severe infection that's spread to the whole body. Now, while the neurosurgeons say they had patient approval to try the procedures, UC Davis officials say that approval was poorly done — that the patients had misunderstood the surgeons and vice versa — leading to a situation where the volunteers can't really be said to be truly volunteering.

This is interesting to me because the surgeons involved really seem to think they were doing the right thing for their patients. One of them told the Bee he'd want the procedure done to himself if he were ever diagnosed with a glioblastoma. But, at the same time, they seem to have made some serious ethics violations in their pursuit of something they thought was good. To say the least, it's a bit of a heartbreaking mess.

Read the full Sacramento Bee report on the case

Notable Replies

  1. Credit for trying. Those people were under a death sentence. If the approval was better performed and the patients knew what they were in for, then all would have been pioneering medicine.

  2. Sorry, but blatantly going against GCP (good clinical practices) and your IRB is never justified.

    The fallout from this will be that any theories around the disgraced docs' theory will now be pretty much defacto discredited, and any REAL research will be greatly hindered.

    UC Davis, btw, is one of the core sites receiving funding for cancer research from the NCI/NIH. These docs' stupid actions put that at risk as well for ALL UC Davis cancer studies and programs.

    Nice job going rogue, guys. Not.

  3. snig says:

    First do no harm. If they died more painfully or faster than they would have otherwise, then certainly not good medicine. Sometimes genius can be hampered by committee decisions, but if you're talking experimentation on humans, I think oversight is not something you get to skip.
    I'm not sure probiotic is the correct term, as I think that implies a non-pathological strain. Here's an old school Nobel prize winning example of something similar:

  4. snig says:

    The review board is also staffed by doctors and ethicists. Doctors as a rule mean well, but, as I said up top, first do no harm. Doctors who are involved in research often have irrational convictions that their avenue of research is the right one. This is coupled with potential financial gain if their research bears fruit.
    Doctors are human, and may be motivated (subconsciously or overtly) by financial gain vs. sound research.
    Example:
    http://www.worklossdatainstitute.verioiponly.com/odgtwc/low_back_files/Deyo_NEJM_2004.pdf

    Painful septic death might well be more miserable than the death they'd otherwise have. It likely shortened their lifespan. I don't blame the patients at all. These kind of studies can and should happen, but nobody gets to cut corners. The doctors should have known better.

  5. I'm all in favour of patient choice, but I think I would like to feel I was fully informed about the BRAN (benefits, risks, alternatives and what happens if by contrast you do Nothing) of the technique from an impartial source, and not from a doctor desperate to experiment. So desperate indeed that they circumvented the normal procedures. It can be read two ways - that they were so anxious to offer the best chance to their patients that they were willing to bend the rules, or that they were so careless of the consequences to the patient that they bent the rules. Who knows? The reason that nearly all medical systems have checks and balances in places to monitor experiments performed on the public is because a doctor may surely be as fallible as anyone else.

    Someone under a death sentence from an incurable illness may not be best placed to make objective decisions about their treatment, especially when doctors can present the same treatment from very difficult angles and give an entirely different impression of the risks and benefits. I don't think seeing this as a challenge to patient autonomy is a particularly helpful way to view it.

Continue the discussion bbs.boingboing.net

17 more replies

Participants