The parents of Baby Fae were appropriately informed of the risks and the experimental nature of the baboon heart transplant the infant received last October at Loma Linda University Medical Center, a federal report made public on Thursday has concluded.
The report, made by a committee appointed by the National Institutes of Health, is the first official appraisal of the ethics surrounding the historic surgical procedure that continues to stir much controversy in medical circles. Loma Linda received the report in mid-February.
The committee was charged only with reviewing the procedures used by the university to assure that Baby Fae's relatives gave proper informed consent for the operation. It did not deal with the scientific basis for transplanting a baboon heart into a human infant, according to F. William Dommel, a National Institutes of Health official who chaired the committee.
Although the report said the committee "was impressed with (the university's) extensive reviews of the . . . protocol," it singled out several weaknesses in the consent procedure that should be corrected in the future.
The committee said, for example, that the expected benefits of the transplant "appear to (have been) overstated" because the informed consent form indicated only that "long-term survival is an expected possibility."
Baby Fae, who was 14 days old when she received the baboon heart on Oct. 26, died 20 days after the operation.
The committee also criticized the Loma Linda physicians and officials for failing to include in their plans the possibility of searching for a human heart to transplant into the infant.
The informed consent form stated that "since size-matched human hearts are not available, we recommend the use of an immature primate donor heart."
"Although it is true that infant human hearts are generally not available," the report said, "the protocol did not include the possibility of searching for a human heart, or of performing a human heart transplant at (Loma Linda) hospital or elsewhere had one been available.
"(We) believe that the document should have clearly stated whether a search for a human heart suitable for transplant into the infant would be made and, if there was to be such a search, the arrangements and chances of success for a human heart transplant. If a search would not be made, the reasons should be stated."
Nevertheless, the investigators concluded that they "believe that as a result of the consent process, the parents of Baby Fae fully understood the alternatives available as well as the risks and reasonably expected benefits of the transplant.
"The informed consent document appropriately explained the experimental nature of the transplant, the extent to which confidentiality would be maintained, whom to contact for answers to questions about the research and a description of what procedures would be followed and what to expect," the committee said.
The committee conducted its inquiry into the Loma Linda facility in December.
Dommel, the chairman, is an attorney who is assistant director of the office for protection from research risks at the National Institutes of Health in Bethesda, Md. Other members of the panel were Robert Lanman, a legal adviser in the U.S. Department of Health and Human Services; Richard A. McCormick, a Jesuit ethicist at the Kennedy Institute of Bioethics in Washington; Dr. Glenn Rosenquist, scientific director of Children's Hospital National Medical Center in Washington, and Alan L. Sandler, a compliance officer for the office for protection from research risks.
A Feb. 27 letter to Dommel by Dr. Harrison S. Evans, vice president of medical affairs at Loma Linda, said the university will follow the committee's recommendation concerning the need to search for a human heart in the future, as well as its recommendations on the part of the informed consent form dealing with long-term survival.
The committee report said its members had been assured by university officials that a second transplant will not be performed until "all the information that can reasonably be learned from the first transplant has been collected and carefully considered."
No report by the surgical team, dealing with the scientific findings of the Baby Fae experiment, has yet to appear in medical literature. A university spokesman said, however, that Dr. Leonard Bailey, the transplant surgeon, has submitted a report to the Journal of the American Medical Assn. for publication.
Cause of Death
At the time of Baby Fae's death, Bailey had said the cause of death was rejection of the baboon heart. But the federal investigators said that at the time of their visit, they were told that the autopsy reports were incomplete and that a definitive cause of death had not been established.
In February, Dr. Jack Provonsha, director of the university's Center for Christian Bioethics, told an Oregon audience that the baby's death probably was caused by a toxic dose of the drugs used to prevent rejection, not by rejection. The university, a private facility 60 miles east of Los Angeles, has declined to confirm or deny that report.
Many immunologists have expressed skepticism at Bailey's contention that a heart from a non-human species stands a good chance of not being rejected when implanted in an infant. They also have questioned Bailey's assumption that the favorable findings he had obtained in preliminary studies transplanting sheep hearts to goats will also hold true for transplants between baboon and man.