The transplant of a baboon heart into a California infant has kicked up a controversy partly because, unlike much trailblazing human experimentation, it never fell into the national warning net that the medical profession and government have created to consider such things in advance.
Normally, a research project of the magnitude of the Baby Fae case would receive considerable advance scrutiny before it is attempted.
If it had been conducted with federal funds, as is much of the nation's biomedical research, the transplant would have been reviewed by government officials and independent panels of scientific experts at the National Institutes of Health.
If it had involved experimental drugs or new devices -- such as the artificial heart implanted in dying dentist Barney B. Clark -- it would have been subject to advance review by the Food and Drug Administration.
If the preliminary animal research had been presented at scientific meetings or in scientific journals, it would have been widely discussed in research circles.
Instead, the transplant of a baboon heart into a human baby was entirely a local decision by officials at the little-known Loma Linda University Medical Center about 60 miles east of Los Angeles.
The Baby Fae transplant and earlier animal experiments by Dr. Leonard L. Bailey and his team were conducted with private contributions made to a research fund from doctors' fees at the medical center, and therefore were not subject to outside review.
And although Bailey said his team conducted years of animal research, he was almost unknown among transplant experts and had published little of his research. Publication in scientific journals is subject to independent scientific review and generally alerts other scientists to new areas of research activity.
The after-the-fact announcement that the transplant had been done pushed the institution into international prominence. But, despite universal sympathy for the baby, it stimulated debate about the circumstances under which the procedure was attempted.
Although Loma Linda appears to have followed the rules, specialists yesterday questioned the way information was released and whether the rules are sufficient.
"This experiment shows us the inadequacy of regulation and review where surgical innovation and research is involved," said Arthur Caplan, an expert on medical ethics at the Hastings Center in New York. He said surgical and medical procedures should receive as much scrutiny as new drugs and devices. "There is no single body that collects information on innovative surgical and medical procedures."
Many in the medical profession are concerned that further federal rules would stifle innovative research.
"It's a close public policy call," said Barbara Mishkin, a Washington lawyer who has been a top member on several government ethics commissions over the past decade. "You don't want the feds interfering in the practice of medicine," she said, and yet, "you want to make sure that the researchers don't let their enthusiasm for the research overcome concern about the protection of human subjects."
By government policy and later by congressional mandate, most medical institutions that receive federal money are required to set up local review boards to rule on each proposed experiment involving human subjects. These institutional review boards are supposed to be composed of a diversity of medical experts, and have input from laymen in the community.
In general, they oversee informed consent procedures to certify that patients and their families are fully informed of the risks of the experiments and other options.
Dr. Charles R. Mac Kay, deputy director of the National Institutes of Health's Office for Protection from Research Risks, said yesterday that since 1972, Loma Linda has filed a plan with his office for the protection of research subjects.
Although the researchers who performed the Baby Fae transplant have not received federal funds, Loma Linda has received NIH funds for other projects and "made a commitment to follow the same policies and procedures at that institution no matter what the source of funding was," said Mac Kay. "In other words, they didn't have a double standard."
Mac Kay said that after the transplant was announced, the chief of surgery at Loma Linda, Dr. Bruce Branson, had consulted with the NIH office "at his initiative." Mac Kay said that he understood that over a 14-month period before the transplant, that it was reviewed at Loma Linda by the institutional review board and by several other in-house panels.
Asked whether experiments such as this should receive more than local review, Mac Kay replied, "That's a good question. That would be well worth discussion in a larger forum." But, he said, "from what they have told us, we feel they have procedurally done what is required and exceeded what is required."
Mac Kay said, however, that his office was not given copies of the informed-consent form signed by the parents nor of the research protocol itself, neither of which have been publicly released by Loma Linda.
University officials have repeatedly turned down requests for the consent form, on grounds of protecting patient confidentiality, even though reporters have suggested that they simply remove identifying information about the family.
Because of conflicting statements from university doctors, questions have been raised about whether the parents of Baby Fae were fully informed about possible alternatives to the baboon heart, including human heart transplants or a surgical repair procedure being done in Philadelphia and Boston.
"If they failed to inform them of alternatives then the consent they gave was not an informed consent," said Mishkin.
"They certainly have an obligation to protect patients' privacy," Caplan said. "At the same time, they must make clear the rationale for what they're doing and allow the public to educate itself."