Posted on 05/27/2007 11:53:09 AM PDT by xtinct
Ethicists Disagree On Experimenting During Crises
The federal government is undertaking the most ambitious set of studies ever mounted under a controversial arrangement that allows researchers to conduct some kinds of medical experiments without first getting patients' permission.
The $50 million, five-year project, which will involve more than 20,000 patients in 11 sites in the United States and Canada, is designed to improve treatment after car accidents, shootings, cardiac arrest and other emergencies.
The three studies, organizers say, offer an unprecedented opportunity to find better ways to resuscitate people whose hearts suddenly stop, to stabilize patients who go into shock and to minimize damage from head injuries. Because such patients are usually unconscious at a time when every minute counts, it is often impossible to get consent from them or their families, the organizers say.
The project has been endorsed by many trauma experts and some bioethicists. Others question it. The harshest critics say the research violates fundamental ethical principles.
(Excerpt) Read more at washingtonpost.com ...
If only we could use trial lawyers instead of accident victims.
Government healthcare anyone?
Entirely too many nitwits to name them all...
“Most patients who receive the current treatments do not survive.”
As a former team leader for the “Dr.Heart” team, AKA code blue, or resuscitation team, I can assure you that the above statement is quite correct. Researchers need to find more successful ways to resuscitate a stopped or fibrillating heart.
It would be impossible to do so any other way than without permission. Impossible.
If you think it’s more ethical to continue with our enormously high fatality rate, than to improve it through experimentation (already tried on animals, BTW), then you need to reexamine your own mores.
OK. Code blue. Shall we try something new, that’s shown on animal experimentation to work better? Or just continue with the same failed methods? Quick, the patient’s dying, time is muscle, what is your decision?
They just haven't even thought two steps ahead, that's all.
I’ve been around the block a bit myself, and I agree with you.
Here’s what the folks behind this have to say about it, and I find myself in agreement with them, too:
Hypertonic Saline
This is a proposal for two multicenter trials of hypertonic resuscitation in two populations of trauma patients to be conducted simultaneously using the same intervention and infrastructure. Study 1 seeks to determine the impact of hypertonic resuscitation on survival for blunt or penetrating trauma patients in hypovolemic shock. Study 2 seeks to determine the impact of hypertonic resuscitation on long term (6 month) neurologic outcome for blunt trauma patients with severe traumatic brain injury. Both studies will be three arm, randomized, blinded intervention trials comparing hypertonic saline/ dextran (7.5% saline/6% dextran 70, HSD), hypertonic saline alone (7.5% saline, HS), and normal saline (NS) as the initial resuscitation fluid administered to these patients in the prehospital setting.
ROC PRIMED
(Prehospital Resuscitation using an IMpedance valve and Early vs Delayed analysis)
Little is known about how to optimize resuscitation for patients with out-of-hospital cardiac arrest. This is evident from the very low survival rates that are currently reported. The advent of automatic external defibrillators (AEDs) and their potential for wide-spread use by less trained emergency medical service (EMS) providers and lay persons has not resulted in the substantial increased survival rates anticipated. This has led to speculation that more and sooner circulation of oxygenated blood to the brain and heart may be important. Resuscitation Outcomes Consortium
(ROC) Investigators propose a large clinical trial, using a factorial design, to test two strategies to increase blood flow. One strategy involves the impedance threshold device (ITD), which enhances venous return and cardiac output by increasing the degree of negative intrathoracic pressure during decompression. The second involves initiating resuscitation with a three minute period of manual compressions and ventilations before rhythm analysis (Analyze Later), rather than at least 50 manual compressions (approximately 30 seconds) before rhythm analysis (Analyze Early). The standard of care for analyzing the patient rhythm for the last 15 years has been to analyze early the rationale being the only effective therapy for ventricular fibrillation is defibrillation. Over the last 5 years, the concept of doing some amount of CPR prior to analyzing and shocking the patient has gained more acceptance. Both strategies are currently being used in EMS agencies with the early analysis still predominating.
https://roc.uwctc.org/tiki/current-studies
That's defined as "free resuscitation if you are still able to pay taxes".
ROC Professional Brochure (United States)
https://roc.uwctc.org/tiki/tiki-download_file.php?fileId=1396
for lay level people:
https://roc.uwctc.org/tiki/tiki-download_file.php?fileId=1071
Yeah, freaking right. Why does this make me nervous?
Agreed. The spin against permission in this article is ridiculous.
Unconcious people can not give permission. My understanding is the law allows treatment in such instances. Tracking data in these cases seems perfectly reasonable. It WILL save lives. Guaranteed. To do anything less is both stupid and unethical.
That “permission” advocates are intervening to stop this is the real scandal of this story. That a newspaper reporter has spun this bizarre news peg is a scandal as well.
Later read/ping.
Why should this make us nervous?
1) If the *good* outcome is still so bad that many cardiologists wear “do not resuscitate” tags themselves, perhaps “just living” isn’t enough.
2) In past, the medical community under government auspices have given unknowing people radiological poisons to see what would happen; conducted “The Tuskegee Study of Untreated Syphilis in the Negro Male”; engaged in eugenics and forced sterilization of “undesirables”; still perform vast numbers of unnecessary surgeries; knew but withheld a simple cure for pellagra from blacks, but not whites.
But it’s okay. Now we’re “Ethical”(tm).
3) If these experimental treatments work, they would have been tested in animals, and would *already* be authorized for use in humans. So I suspect that this experiment is being done simply to protect these hospitals from *litigation*, until enough statistics can be gained so that this experimental treatment can be defended in court.
That is, right now, if you survive, most likely you will be only a fraction of the person you know. While these techniques might keep a little bit more of you from dying, you still won’t be anything like you are now.
GOTO 1)
“If the *good* outcome is still so bad that many cardiologists wear “do not resuscitate” tags themselves...”
Did you make that up yourself, or just fall for it?
Not my problem. Since most drugs, and most techniques don't work the first time, it's likely that overall the odds of something new working are lower than what we have.
So, get the consent ahead of time (like donor cards) so that people who are willing take the risk are part of the trial. Folks with small kids to raise might not want to take the risk. Others might.
Or are you arguing that public good simply overrides individual rights in this case?
“If the *good* outcome is still so bad that many cardiologists wear “do not resuscitate” tags...”
That would adequately describe the current state of resuscitation outcomes.
We should encourage this study, in the hope that it will drastically improve future outcomes.
There is very little to lose, unless you consider a 95% mortality rate too risky to challenge?
95% mortality is the present outcome, and the 5% survival rate often includes serious brain injury, short life spans, and those only with intensive and usually invasive interventions.
You are arguing against trying to find a way to improve this?
“...get the consent ahead of time (like donor cards) so that people who are willing take the risk are part of the trial.”
Just a couple of tiny problems with that.
Not enough people will sign up for it, and not because they don’t like the idea, but because it’s just too much bother.
Identifying the volunteers would take valuable seconds away from the treatment.
The EMT’s would have to carry both the old and the new med kits to the scene. They have enough to carry already.
The study would never get done, due to the difficulties involved with the massive red tape of registering volunteers.
It would also, just by the way, cost a fortune, money better spent on the study just as it is.
Lawsuits from those who received the “old” or “new” treatment would ruin the study.
That is, "I've got an experimental drug that might help people regrow amputated limbs. So I'd like to chop one of your legs off to see if it works. You can't say 'no', and you can't sue if it doesn't work."
You see, that's the point. Lots of people have strokes and heart attacks every year. And lots of them know that they are high risk for that. So how hard is it to ask them ahead of time if they come into the ER, if we can try an experimental treatment on them?
Why do they even feel a need to do it to people involuntarily? Why was that even proposed in the first place, other than convenience?
I'm concerned that there is a general failure of medical ethics all over the country. More and more, there *is* no point at which what Dr. Frankenstein might do is unacceptable. Here is an interesting example:
http://tinyurl.com/ypredz
"If you marked "organ donation" on your driver's license, you may have given consent for something you can't imagine.
Over the past year, KIRO Team 7 Investigators have repeatedly exposed how the King County Medical Examiner’s Office traded hundreds of human brains to a research lab, collecting $1.5 million along the way. Dozens of families say King County failed to get proper consent. Four sued...
...A King County judge has just ruled that "heart-mark" allows your organs not just to be transplanted into a living person, but also your corpse donated to science. your family can't do anything to stop it..." ***********
This is on top of existing federal law that once you surrender any part of your body, including tissue, fluids, DNA, etc., to others, you retain no rights to its use or misuse.
Elsewhere, not in the US yet, thankfully, organ donation is no longer being considered voluntary.
In Britain, doctors are now denying surgery to smokers and the obese, and deciding for couples if their children can survive or be starved to death if they are crippled.
In short, there is a crisis in ethics in medicine, and until they decide to have an ethical sense, doctors no more deserve liberties with the public than do violent criminals.
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