LOMA LINDA, Calif. — Loma Linda University Medical Center on Friday released its long-awaited "protocol" on how it would use brain-dead babies as organ donors--conceding as it did so that the guidelines may be too ambiguous to work.
The protocol provides medical, legal and ethical guidelines under which a baby born with a fatal defect called anencephaly could be sustained with a respirator so that its vital organs would not deteriorate and therefore could be donated.
Without life-sustaining equipment, anencephalic babies usually die within a few days after birth.
Center of Controversy
The approach is controversial because some physicians and ethicists say it is unethical and inhumane to artificially keep an anencephalic baby alive in order to harvest its organs, even with parental consent.
Physicians also are unsure whether anencephalic babies, who are missing most of their brain, can experience pain.
To address this controversy, Loma Linda stated that it will administer a painkiller, Demerol, if such an infant shows any signs of discomfort or distress while it is on a respirator.
But the effects of a painkiller would make it even more difficult to reach a determination of brain death because the drug could induce or mimic some of the very indicators of brain death, said Dr. Alan Shewmon, a UCLA pediatric neurologist.
"You cannot diagnose brain death in the presence of suppressant drugs," added Dr. David L. Coulter, a pediatric neurologist at Boston University School of Medicine.
Loma Linda physicians said such concerns would not be a problem because they would administer another drug, narcan, to counter the effects of the painkiller. This is a highly unusual procedure when physicians are attempting to diagnose brain death.
Loma Linda's protocol also states that it would not remove any organs until an anencephalic baby is determined to be brain dead. To avoid any conflict of interest, two Loma Linda physicians unaffiliated with the transplantation team will determine brain death, officials said. Loma Linda officials added that in the event of problems or questions, an outside consultant would be called.
The guidelines state that such a baby would be artificially supported for only seven days.
During this period, the guidelines further state, doctors would check every 12 hours to see if the baby is brain dead. At the end of the seven days, a baby which is not brain dead would have its life-support discontinued and be allowed to die.
The guidelines were issued as a result of the requests from parents of anencephalic babies wishing to have the babies' organs donated.
First Use of Protocol
A week ago, Loma Linda agreed to implement the protocol for the first time involving an Arcadia couple, Brenda and Michael Winner, who are about to become the parents of an anencephalic infant.
Their child was expected to be born as early as last Saturday, but still has not arrived.
Still another uncertainty is whether the respirator could prevent brain death from occurring, according to Shewmon and others. Loma Linda concedes this point.
"It is an unanswered question," said Dr. Stephen Ashwal, a child neurologist at Loma Linda and one of the authors of the protocol. "That will be one of the most important pieces of medical knowledge to come out of this."
Shewmon criticized that approach. "What concerns me most is that they are just kind of going out on this limb without any backup or consensus in the neurologic community on something like this," he said. "For one thing, determining brain death in a newborn infant is . . . uncharted territory."
But Loma Linda officials took a different view.
"This represents two years of struggling with the issues and problems," said Dr. Joyce Peabody, chief of the neonatology division at Loma Linda, "But we are at a stage where the questions that remain cannot be answered without a trial of the modified medical management."
Louis Sahagun reported from Loma Linda and Robert Steinbrook from Los Angeles.