A California hospital's attempt to save a dying infant with a transplanted baboon heart, widely criticized last year as too painful and too risky, met federal standards for protecting human patients, the National Institutes of Health has concluded.
A seven-page report, written after an NIH team visited the Loma Linda University Medical Center in December, said doctors overstated the expected benefits of the controversial operation on Baby Fae, as the infant was called, and did not make clear why they did not look for a human heart donor.
But the report concluded that a university board's review of the plans for the Oct. 26 operation was "appropriate" and in accord with federal regulations.
"The parents of Baby Fae fully understood the alternatives available as well as the risks and reasonably expected benefits of the transplant," said the report signed by a six-member NIH team. "The institution accepted responsibility for the . . . procedure and allowed it to proceed only after appropriate issues and concerns had been explored, discussed and resolved."
The university released a copy of the report today, along with a copy of the consent form, signed by Baby Fae's parents, previously withheld from reporters.
In a Feb. 27 response, Dr. Harrison S. Evans, university vice president for medical affairs, called the report "fair, balanced and constructive." He indicated that the university would implement NIH recommendations for improving the consent form.
Baby Fae, born with a severe deformity called hypoplastic left heart syndrome, lived nearly 21 days with her baboon heart, five times as long as any human had survived with an animal heart. She appeared to have died from the effects of rejection of the alien tissue and of drugs used to prevent rejection.
Some medical ethicists and editorial writers criticized Dr. Leonard Bailey, who led the operation, as having operated on a human without enough research on animals and as not giving sufficient consideration to a human heart transplant or an alternative procedure designed to correct the deformity.
Bailey argued that there were far too few infant donors to give the more than 300 babies born each year with hypoplastic left heart syndrome a chance to live. He said the corrective procedure, developed by doctors in Boston and Philadelphia, had not been proved to assure survival beyond childhood, or any chance of a normal life, despite some initial successes.
The informed-consent form released today is a single page, far shorter than those used in other experimental operations such as the first permanent artificial-heart transplant. It devotes one sentence to the corrective procedure, saying that it has "generally been unsuccessful." It notes the possible adverse effects of drugs on the baby and calls the baboon heart transplant "very uncertain and highly experimental."
The NIH team applauded Bailey and the hospital staff for their "informed-consent process," including long meetings with the parents that described alternative procedures and detailed results of animal experiments.
The team noted, however, that the consent form did not discuss compensation in case of injury, explain a claim of "long-term survival" from the operation, or explain why a human donor was not sought.
The Baby Fae operation did not involve federal funds, but the university previously had agreed to abide by federal regulations that require researchers to minimize risks, to pick patients equitably and to seek informed consent from patients or their guardians.
The NIH team said it endorsed the university's intention to put off a second baboon-to-human transplant until the Baby Fae operation "has been thoroughly evaluated."