Organ recovery procedure may erode public trust

Line between life and death is unclear, some argue

When and how does death actually occur? Should it be hastened in any way if another patient may benefit? These thorny questions are at the heart of an escalating debate over one particular method of organ recovery and are threatening to damage the public’s trust in all transplant efforts.

Non-heartbeating organ recovery is practiced in a limited number of donor hospitals across the country. Some of these hospitals have developed an institutional protocol for retrieving organs from a patient whose heart has stopped but who does not meet the traditional criteria for brain death. Other donor hospitals use a protocol established by their local organ procurement organization.

Media coverage scares off donors

In late April, CBS' "60 Minutes" aired a story on non-heartbeating donors that called one hospital’s protocol an "intent to kill." The searing report focused on programs in Cleveland and in Madison, WI, that authorize the administration of two drugs prior to withdrawal of artificial life support. (The Cleveland Clinic protocol was written but never implemented.) The dilemma is whether one of the drugs, regetine, actually hastens the patient’s death, and if so, whether this is justifiable.

The "60 Minutes" report was preceded by a story in the local Cleveland newspaper. For six days after that newspaper report was published, the Cleveland Organ Procurement Organization (OPO), Lifebanc, received no calls regarding a potential organ donor, says Debbie May-Johnson, public affairs director. Donations for the month of April dropped from 29 in 1996 to 14 in 1997. Johnson says there is no doubt that the dramatic decrease was caused by the adverse media reports.

Patient autonomy

Organs recovered for transplant are retrieved after the recovery team has obtained the consent of the next of kin, says Joel Newman, director of communication for the United Network for Organ Sharing in Richmond, VA. This includes all non-heartbeating donations, he stresses. This raises the question of whether the surrogate decision maker can consent to organ donation through a non-heartbeating protocol when a patient suffers severe brain damage but is not brain dead.

In addition, can the drug regetine, which vasodilates the organs and increases the chance for a successful transplant of some organs, be administered to a patient in this situation even though most medical experts agree that it hastens death by a few minutes? Those who question non-heartbeating protocols say that this fine line is too dangerous to cross.

"This drug is clearly contraindicated in patients with an intracranial bleed," says Ronald E. Cranford, MD, associate professor of neurology at Hennepin County Medical Center in Minneapolis.

Even when regetine is not administered, Cranford says retrieving organs from non- heartbeating donors is ethically troublesome. "The crux of the problem is how can you tell when the patient is clearly dead?" he asks.

Many experts in the field of bioethics, including Cranford, say the current controversy points to a need for strict, uniform criteria for recovering organs from non-heartbeating patients.

"The only way we can respond to this is to have uniform guidelines that everyone can agree on," admits George Agich, PhD, F.J. O’Neill chair of the department of bioethics at The Cleveland Clinic. "Right now, it will be difficult for any donor hospital to move ahead, because their efforts will be tarred with the same brush as ours."

Agich says the Cleveland Clinic developed its non-heartbeating donor protocol after Lifebanc asked it to be the site for a pilot project in the Cleveland area. The hospital’s staff neurointensivist played a significant role in ethics committee discussions of the protocol that was modified from the University of Pittsburgh Medical Center’s (UPMC) protocol. (See story on Pittsburgh protocol and other NHBD protocols, Medical Ethics Advisor, April 1995.)

The hospital decided to modify the "Pittsburgh Protocol" by adding the second drug, regitine. UPMC decided it would not use regetine because "it is harming the patient by hastening their death and it is not medically necessary," says Michael DeVita, MD, assistant professor of anesthesiology and critical care medicine. DeVita chairs the UPMC ethics committee.

He says what is needed is not a national standard but what such a standard would surely mandate — auditability for the practice. UPMC has published the results of its non-heartbeating donor program widely. "Often it is perceived — not just real — abuses that generate these calls for a uniform medical standard," he says.