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.
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.
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:
**Documents show the surgeons got the consent of three terminally ill patients with malignant brain tumors to introduce bacteria into their
open head wounds, under the theory that postoperative infections might
prolong their lives. Two of the patients developed sepsis and died,
the university later determined.**
How dare a doctor and patient agree to use a technique that has not been hallowed and sanctified? Next thing you know they'll want to start treating patients as if they were actual human beings. Patients have no right to information or consent, it just makes the poor childish louts unhappy.
I'm kidding! Please don't withhold my prescriptions! I was just kidding!
"the surgeons involved really seem to think they were doing the right thing for their patients".
Yeah, plenty of pinheaded surgeons that will always think that, hence the phrase "the operation was a success, but the patient died". The smart guys will measure twice, cut once, or even not at all.
Their Institutional Review Board was well aware of the dire prospects of the patient/subjects. There was no excuse for trying to bypass the review board.
Yeah, screw what patients want. They should never get to decide on their own whether a surgeon's ideas are worth trying - it's clear only a restrictive and hidebound bureaucracy devoted to maintaining a monopoly on medicine should have such powers.
So which patient should they try this on next? Or should they maybe see if they can get it to work in rats first?
Well maybe the terminally ill patients who willingly volunteer to cooperate with the surgeons, like the previous ones did?
But you can't trust them. They aren't doctors, and thus have no right to choose what to do with their last hours.
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.
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.
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.
Well, there's also a third way to read it.
Perhaps the patients had IQs above 50, and thus knew they were dying a painful, hideous and unavoidable death. Perhaps they wanted something meaningful to come of their inevitable suffering and decided that by agreeing to participate in a medical experiment that was quite likely to end horribly, they could try to contribute some knowledge to the rest of humanity and the human world they were bound to leave.
But as I've already said, we should never let regular people make their own decisions - the ignorant fools might make a mistake. Or even be misinformed. Only an unwieldy, prestige-driven bureaucracy composed of hereditary elite physican castes should be able to decide if a dying person may sacrifice themselves for the advancement of science. Anything else would just be all higgledy-piggledy and clearly must be sanctioned harshly, perhaps by the cutting off of hands.
Edit: I'm not trying to mock you, I think you raised good points. My mockery is reserved for the medical authorities in this case.
Where does "do no harm" come from? It's no part of the Hippocratic Oath (which is mainly concerned with protecting the medical profession's secrets from outsiders) and it's certainly not part of today's medical practice.
I think you've watched too much "House" and are assuming that the surgeons who did this must have been brilliant and on the right path, and review boards must be filled with stodgy traditionalists. Really smart people in research sometimes go down the wrong pathway. Entire fields of practice often do the wrong thing because leadership in the field led them them the wrong way (HRT, stress is the cause of stomach ulcers, lobotomies, etc.) It's entirely possible, for some unforseen reason, that this protocol won't work with the conditions that were tried, and if there were 100 people in the study, all 100 would die a quick, painful end. What if the review board had a member with a body of knowledge or an insight that would have made the treatment protocol successful? There are myriad last ditch treatment regimens that have differing amounts of data that are also promising, but fall well short of gold standard. Where those presented as options, or was this given as the only alternative to death? Even if these doctors are smart, there are plenty of successful docs who aren't, but have devoted adherents. ex: http://en.wikipedia.org/wiki/Mehmet_Oz
Is it ok if they're allowed to do these kind of experiments, with just a signed consent form from consenting patients?
I've worked in research, I've volunteered as a test subject in studies, including one that involved being injected with isotope. It's important that research get done, but it's damned foolishness to not have oversight.
I don't know 'House' - I haven't watched much TV lately. But I am familiar with bureaucracies and their tendencies.
Speaking seriously, I don't think oversight should mean punishing physicians for failing to maximally extend the lifespans of suffering, doomed patients who willingly took part in experiments. If anything, the margin of error for oversight should extend in the other direction, so that a few physicians who may have misinformed terminally ill patients might conceivably get off with a minor reprimand instead of having license to practice revoked. Your remarks about the benefits of ideal oversight (which I've personally never encountered, and suspect is vanishingly rare) are insightful, though.
And I freely admit that I think experimenting on terminally ill human volunteers is vastly more ethical than experimenting on any other sort of sentient animal, so my view is clearly not mainstream.
Dammit, you have tricked me into replying seriously with your reasonable and informative manner. Curse you, Snarkslayer Snig!
Props by the way, for the "Avatar" avatar.
Props to @Kimmo who made it for me!
"The patients were terminally ill and could make up their own minds" is not a valid excuse for this.
Plenty of desperate people will turn to all sorts of quackery in the hopes that it will save them. That does not mean that those who push the quackery on them are in the right.
The doctors had only a hunch that maybe in some weird way it could possibly work. This is not nearly enough to scientifically justify a decision on, and ego almost certainly played a role in this.
"Isn't it better to try some idea, even if only a tenuous hypothesis?" Maybe, but there are millions upon millions of half-baked tenuous hypotheses, many of them involving magnets or quantum effects or something, and there is a process involved in pushing them from "half-baked tenuous hypotheses" to "actual possibilities that are worth experimenting on people."
There is also the issue of informed consent. It's a difficult one, because adults can make their own decisions, and that is very important, it's true. But when you're dying and some brilliant surgeon tells you he might have an experimental procedure no ones ever tried before, but he sure it will work, the balance of power starts having a tricky effect on "informed consent." Not to mention that it sounded like in this situation the patients weren't even fully understanding the details.
It's great that people try new hypotheses, but things like IRBs exist for a reason, and that's to prevent people from being experimented on without oversight and scientific backing.
You just made up all that stuff about these people not being informed or the surgeons promising it would work.
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