You didn’t get enough yesterday? Here’s another gag-inducing story from Jonathan Eisen. A while back, an MD at UC Davis tried an experimental cancer treatment on three patients: to amplify the immune response to a glioma, they injected fecal bacteria into the patients’ heads.
Two UC Davis neurosurgeons were treating terminally ill brain cancer patients with an unapproved, experimental treatment that is referred to as “Probiotic Intracranial Therapy for Malignant Glioma”. The treatment involved purposefully infecting patients brains with a bacterium Enterobacter aerogenes apparently because of prior anecdotes and case reports that suggested that patients with these brain cancers who also had brain infections might live longer than those with the cancer but without the infection. According to the article, there was an investigation at UC Davis into the practices of the surgeons. It was determined by UC Davis that they did not have IRB approval to carry out the treatments and that there were some other issues with the practice going on. At the conclusion of the investigation UC Davis wrote a letter to the FDA detailing the case and has banned the two neurosurgeons from performing medical research on humans.
Notice that key statement? No IRB approval. They just skipped that whole institutional review thing and squirted something radical, untested, and backed only by anecdote into the heads of very sick people. Two died within weeks, another died a year later.
What happened to the doctors? They left UC Davis after a review found their behavior unethical.
I know what some of you are saying: Oh, no, another important researcher hounded out of science by a politically correct witch hunt. How dare they ruin his career? But don’t you worry. Once you reach those exalted levels where you get to ignore trivial ethical constraints, no amount of protest can affect you.
Dr Paul Muizelaar has a new job at Marshall University in West Virginia. The university knew all about his history.
At UC Davis, the live bowel bacteria had been purchased for study involving lab rats. But Muizelaar and the other doctor introduced the bacteria into open head wounds on a man and two women in 2010 and 2011. Each had been diagnosed with glioblastoma, a highly malignant brain tumor. Muizelaar said all three consented to the procedures, which were done with the hope that their immune systems would be stimulated.
A UC Davis statement said internal investigations found school policies were circumvented, research regulations were violated and directives made by university leaders were defied.
That’s just astonishing. Read that last paragraph again. Yet Marshall thought it was a great idea to hire this guy. I can’t say it’s a case of falling upwards — UC Davis seems to have some ethical standards, while Marshall is untroubled by them — but he’s at least flopped down into a nice soft cushion.
Reading more about this case, I encountered a post by Orac:
http://scienceblogs.com/insolence/2013/08/26/in-clinical-research-the-road-to-hell-is-paved-with-good-intentions/
Which refers back to PZ:
http://freethoughtblogs.com/pharyngula/2013/08/25/just-in-time-for-my-cancer-class/
The circle is complete.
My school hired a dean based on a program he had introduced at another school. This school was put on probation for this program and apparently some prosecutions ensued – two days before they made the hiring decision. With full knowledge that what he had done was not acceptable, they hired him for the main purpose of beginning this program at our school.
We lost my MIL 7 years ago to ovarian cancer.
We lost my mom 3 years ago to Melanoma.
My dad is currently fighting terminal Lymphoma.
I feel I can say that this:
absolves those doctors of NOTHING!
Facing “The Big C”, hope is all you got and will lead you to consent to damn near anything.
I don’t think I have the spoons to say what I’m feeling towards those two.
As long as he keeps one step ahead of the consequences of his failures, his future is assured!
Of course they did. They’re horribly ill and the doctor promises a miracle. Probably in Medicine, a language few people understand.
And in the UK, a crazy bill is being pushed through parliament by a millionaire lord and former advertising executive designed to legalise just this kind of unfettered experimentation on patients. Very dangerous.
Usernam3 @4: He has already moved on to an even better job, and our school has just begun implementing his program.
Pardonnez mon français, mais…
The doctors were merely trying to make more people like themselves. You know, shit-for-brains.
I’m probably going to get into trouble for saying this, but I understand the temptation here. GBM is a horrible disease and treatment does very little to even slow it down. This leads to the temptation to try something radical, even if there’s only minimal support for the idea. If they had gone through the proper channels and gotten their bacteria into the head idea approved by the IRB, they could have (maybe) done this experiment ethically–but the people in front of them would not have benefitted because the IRB process takes time.
That being said, the kindest thing I can think to say of someone who gave in to that temptation is “what an idiot”! IRBs and all those regulations exist for a reason. As others have pointed out, the patients are desperate and scared and ready to do anything that might help them. Which this didn’t. It’s hard to say for sure, but it sounds to me very likely that 2 of the 3 patients died prematurely because of the experiment–GBM doesn’t usually kill within weeks of diagnosis. The intent may have been beneficent, but the acts weren’t. No one can trust themselves with that kind of uncontrolled power: that’s why we have to have IRBs and regulations. Because the patients get carried away with the hope of a miracle cure and the doctors get carried away with the hope of helping the patient and getting the glory of curing a deadly cancer–and the result is two people dead unnecessarily soon.
Zenlike @1
thanks for that…I thought I remembered PZ covering this at the time!
OK, ignorance is showing on me here: I’m reminded of the early days of the AIDS crisis when there were no treatments and the FDA was dragging its feet regarding various drugs. The work of ACT-UP to cut through the bureaucracy, from what I understand, was very helpful. As many said, “You say it will take five years to approve but I’ll be dead in two.”
I get the feeling that with at least certain kinds of cancers, there is a similar situation: There is very little hope of living to see the “breakthrough” that’s coming. So how do we manage this? I also seem to recall that some of the reason for the progress we have made with childhood cancers is because of the coordinated effort to put all of these “trials” together. If I understand correctly, every child treated for cancer is part of a clinical study because our understanding of such cancers is so poor compared to others (or, at least, it was at the time the protocol was initiated). Too many doctors had no idea how to proceed because they only had no previous experience and thus were flying blind to the work of others. By coordinating efforts to get information about treatments out to others, it helped increase our understanding of what worked and what didn’t.
So my quick response is that I don’t care that it’s fecal bacteria. I do care that even the most basic concepts of consent were violated. Is it my ignorance that all the things I want about patient empowerment and trying to get treatments through trials quickly (and safely) are already there and this was just way out of line?
The law now allows for “compassionate use” of anti-cancer drugs (or early anti-AIDS drugs years ago), but those cases not in trials are ignored, no matter what the outcome except as heresay.
There’s a saying in my business. You can do it quickly, with good cGMP controls, or cheaply. Pick two out of the three options, if you are lucky.
Information on “expanded access” from the FDA. Note that many start-up companies have limited supply of their drug product, so they are reluctant to participate in such programs.
Funny Diva
I don’t ‘blame’ PZ or anything for covering this twice, this stiry deserves ‘airtime’, and these doctors deserve to have their names plastered over the internet for their lack of ethics.