Posted on June 16, 2014 at 10:17 AM
A New York Times article a few weeks ago highlighted a clinical trial that just started in Pittsburgh. The provocative title “Killing a Patient to Save His Life” summarizes the technique that will be used on patients who present in cardiac arrest from a penetrating injury (e.g. gunshot or stab wound.) It involves replacing blood with cold saline to induce hypothermia and decrease the body’s demand for oxygen. Once the patient is in a state of “suspended animation” the surgeons have time to repair whatever organs were shot or stabbed, then they can give the blood back and warm the patient up. It’s called Emergency Preservation & Resuscitation (EPR.)
A few of the ethical concerns that have been raised are the issue of informed consent, the fact that most patients who will qualify for the study are young black men, and the cognitive function of people who survive ERP is yet unknown.
The informed consent issue seems to be the biggest concern for people who have been commenting and Tweeting on this, but I think that is based on some misconceptions. Most of the interventions that occur in order to save someone’s life in a situation where they have been stabbed or shot is done under the rubric of “implied consent” using a “reasonable person” standard. Intubation, chest tubes, pericardiocentesis, thoracotomy . . . after you’ve been shot and lose your pulses, no one is explaining the risks and benefits and having you sign the bottom of a consent form before they try to save your life. So it is a mistake to think that “informed consent” in the way that most people conceptualize it is happening in these circumstances. But that is totally reasonable and ethical because as a society we accept that we will surrender some autonomy for the sake of saving our life when we are that severely injured.
Also, there is clearly therapeutic equipoise in these cases. In most ERs in the country if you arrive pulseless with a penetrating chest wound they would just pronounce you dead. In large Level 1 trauma centers they will try to save you. There isn’t really a “gold standard” that can reliably save these folks–every case is a hail Mary. I spent 5 years doing trauma surgery in one of the busiest “knife and gun club” inner city hospitals in the country, and unfortunately took care of many patients like this. Every case you may be trying something new because something else didn’t work last time, and then if it works you use that same technique the next time. If it seems to work most of the time, you review your data and try to write up your “advance.” At least in this study they are being very systematic and prospective about the data collection, which will yield much better data and the ability to extrapolate will be more robust.
So the ethical challenges initially raised about this study do not seem insurmountable. But what people have totally missed about this study is that this does not really seem to be about bringing people back to life and getting them back to the streets. This is about organ preservation for organ donation. People are dying every day waiting for an organ on the transplant list. Usually a trauma patient who dies from hemorrhagic shock from a penetrating injury goes through a prolonged period of resuscitation and warm ischemia, so they are bad donor candidates (i.e. their heart, liver, lungs, etc are no longer transplantable.) If they are cooled and preserved from the moment they hit the door, and then they never regain consciousness, then they can be declared brain dead (if they meet the criteria) or participate in donation after cardiac death. It is remarkable that no one has pointed out that the University of Pittsburgh has been a world leader in transplantation almost since the field began. A fortuitous byproduct of iced-down neurologically devastated people is the potential to salvage their organs and put them in the hands of some of the most skilled transplant surgeons in the country.
I think most of us agree that organ donation is a great lifesaving and life-changing thing and that organ recovery is extremely important to save lives. The question that needs to be answered for me is, “If the actual goal of EPR is to preserve and recover organs in order to save the lives of patients needing a transplant, is it ethically permissible?”
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