Summer Guide: New UPMC procedure doesn’t meet ethical standards

In late March, doctors at UPMC Presbyterian Hospital began searching for a trauma patient to be the first human subject to be placed in what science fiction has, for years, called “suspended animation.”

The perfect trauma patient is a gunshot or stab wound victim who had experienced 50 percent blood loss and who would have less than a 7 percent chance to survive their trauma.

Dr. Samuel Tisherman, the clinical trial’s lead doctor, calls the procedure emergency preservation and resuscitation. 

“EPR buys time because the body can’t tolerate not having blood flow for even more than just a few minutes. By cooling them, we can buy time by slowing down the processes that occur when there is no blood flow to vital organs … Hypothermia appears to have a great preserving effect,” Tisherman said in a video explanation of the procedure. 

When a trauma patient fitting the trial’s requirements arrives at the hospital, Tisherman and his team will replace the patient’s blood with a cold saline solution, which will rapidly cool the body to about 10 degrees Celsius in approximately 15 minutes.

At cooler temperatures, the body does not demand as much cellular activity and the processes that move along cell death slow down.

While the body remains in a state of halted cellular activity, or “suspended animation,” surgeons can repair the body’s structural damage and revive the patient by slowly reintroducing blood, which will warm the body and allow cellular activity to resume as normal. 

Research for this technique has been ongoing for over a decade now and, in early 2014, the Food and Drug Administration gave Tisherman and Dr. Peter Rhee, a surgeon from the University of Arizona and a key researcher in the development of EPR, the go-ahead to start a clinical trial.

As a scientist and aspiring physician, I have faith in the years of research and animal trials that have prepared EPR for human patients. But, as a prospective patient of this procedure, I am more skeptical — so I set out to investigate the legal and ethical terms that bind human experimentation.  

Tisherman, Rhee, the Department of Defense — who funded the research with hopes that EPR will save the lives of thousands of American military troops — and the FDA have agreed that the trial is legal because, according to the United States’ implied consent law, physicians are allowed to administer any necessary medical care to save an unconscious patient’s life, even if consent has not been given. 

Coincidentally, the majority of trauma patients arriving at UPMC Presbyterian cannot consciously give consent to any medical care because of severe injury, and families are often not present to give timely consent. The qualifications for patients to receive EPR include a less than 7 percent chance to live under current medical care — they most likely would not be able to give consent. 

So, according to the law, the EPR clinical trial is not breaking bounds. But that does not mean that the EPR clinical trial is not crossing the bounds of ethical considerations. 

In scientific and medical research, there is a long history of ethical guidelines regarding human experimentation that serves to protect patients and limit the scope of physicians and researchers. The EPR clinical trial violates them all.

Take the Nuremberg Code, a set of ethical guidelines regarding human experimentation that has guided and limited medical research since its implementation following World War II. The code emerged in response to the German physicians conducting medical experiments on thousands of concentration camp prisoners without their consent. Most of the patients died or suffered irreversible injuries as a result of the experimentation. 

While the ethical code does not carry legal force, it solidifies that the EPR procedure is unethical because, at the most basic level, patients are not able to give consent to an experimental procedure.

The researchers recognized this flaw in their trial and they tried to gain the consent of prospective patients via a “community consultation.” They created a website that allows patients to opt out of the procedure. 

Patients who choose to opt out are given wrist bands indicating their unwillingness to undergo the procedure. 

But not opting out is not the same as giving consent.

To determine whether Pittsburgh residents knew about opting out, I asked 35 passersby outside the main entrance of UPMC Presbyterian Hospital three questions:

Are you aware of the experimental EPR technique? If so, do you know that you have the option to opt out? And, do you think it’s ethical to subject patients to the procedure even if there was no option to opt-out? 

Of the 35 questioned, only three had minimal knowledge of the procedure and all three were aware they could opt-out but two did not know how to opt out. On top of that, 28 of those questioned believed it was unethical to subject patients to any experimental procedure without giving consent regardless of a patient’s survivorship or post-injury functional status.

Not only did the “community consultation” fail to actually gain consent of clinical trial patients, the researchers’ passive effort to educate and inform the public was ultimately a failure.  

A simple and ethical solution to the problem would be to require patients to opt in to a clinical trial rather than opt out of the trial. While this would minimize the pool of potential patients — which currently encompasses Pittsburgh’s population as well as the population of nearby cities and towns that lack Level I Trauma Centers and Emergency Departments — it will ensure voluntary patient consent and will also require physicians and researchers to spend more time educating the local community about the technique.

Yes, each new pharmaceutical, medical procedure or surgical technique requires physicians to delve into the unknown, to explore the fine line between death and life and to ultimately risk lives. Despite the life-saving potential of the EPR technique, the ends do not justify the means. 

If one clinical trial is permitted to push the bounds of ethics, then future clinical trials will outright disregard them. Going to the doctor’s office or unconsciously arriving at the emergency room should not subject you to countless experiments, further injury or even possible death. 

Write Jessica at jnc34@pitt.edu