Baby Fae: A Breakthrough or an Aberration?

Dr. Leonard L. Bailey, the California surgeon who supervised the pioneering transplant last month of a baboon heart to the infant Baby Fac, Predicted soon after the procedure was completed that his tiny patient would lead a "long and healthy" life.

The world waited and watched for encouraging signs, and for three weeks it looked as though the prognosis from the Loma Linda Medical Center would prove as steady and true as the pulse of the first-ever human recipient of an animal heart.

Then last week, after Bailey had all but convinced Baby Fae's news-hungry fans, that all was fine and as suddenly as the story of her heart had flashed across newspapers and television screens worldwide, the infant died.

Bailey vowed to try again, not wanting to waste the lessons of what he called a "pioneering effort." But others, including many Harvard doctors familiar with transplant procedures, as well as government officials and animal-rights activists had a different response to the death Baby Fae.

Calling Bailey's transplant unethical, impractical and improper, experts at Harvard and other observers have expressed at Harvard and other observers have expressed anger over Bailey's experiment, charging that the procedure performed to replace Baby Fae's defective original heart simply could not succeed because it ignored the bounds of all current life-saving technology.

Several doctors interviewed this week suggested that Baby Fae had little chance of survival as a result of this operation and suggested several alternatives which may have saved her life. In addition to the medical controversy, an ethical dilemna has developed as a result of Baby Fae, founded on the lack of government regulation and planning previous to the operation.

You can count the number of animal-to-human transplants on one hand and they have all been totally hopeless.

"For all practical purposes there is not evidence to suggest that a xenograph [species-to-species] transplantation could be successful," Professor of Medicine Nicholas L. Tilney '58, one of several doctors to conduct the first heart transplant in New England, says after Baby Fae's death. "There is no biological evidence to suggest that the immune system could be sufficiently supressed to subdue the baby's rejection of the heart, and there must be some biological evidence before one can conduct on operation."

"You can count the number of animal-to-human transplants on one hand and they have all been totally hopeless," says Professor of Surgery Lawrence H. Cohn, another heart transplant pioneer. The implantation of a foreign organ from a different species into a human causes continuous, massive rejection even though the organs are functionally similar, he says. Doctors are barely able to repress rejection in human-to-human transplants, he added.

But Cohn did offer some positive encouragement also. He says the new wonder immune-suppressions drug, cyclosporin, which was pioneered for use with heart transplants at the Harvard-affiliated Brigham and Women's Hospital (BWH) last year, had not yet been tested in cross-species transplantation and indicated that Bailey was going to attempt the operation. However, he says that the likelihood of success even with the new drug was minimal.

"It is extremely suppressing that she survived as long as she did," says Tilney, adding however that he attributes this to the immaturity of Baby Fae's immune system and her increased tolerance for foreign organs as a neo-natal and not the success of the operation. "She couldn't recognize the difference between herself and the other and thus did not reject the heart as quickly as an adult would have."

The operation also involves much more than the theoretical potential of the transplant to extend the baby's life, it also involves presenting a true assessment of the process to the public, says Raphael H. Levey, chief of transplants surgery at BWH. "I'm not glad the operation was tried at this time. Cyclosporin is not the miracle drug it's cracked up to be and it's not good to create hype and give false hope to the public, while seeking undue publicity for an unjustified operation."

But Professor of Surgery Gilbert H. Mudge, another heart transplant specialist, looked more favorably upon the operation. He emphasized that cyclosporin had yet to be tested in xenographs and there was a possibility of such transplants being successful. "I think it was a heroic attempt to save a life which would have inevitably died, and, although the operation was not a breakthrough, it did use a new technique [cyclo-porin] and therefore was reasonable."

Although very few experts believe that the transplant stood a chance of long-term success, there remains this question of whether any alternative procedures to Bailey's xenograph operation existed.

The day after Bailey's five-hour operation, a report in the Los Angeles Times confirmed that a human heart was available at the UCLA medical school located only 50 miles from Loma Linda. In addition, other procedures, namely the so-called Norwood operation--which attempts, by surgery, to make the defective heart function normally--used extensively by Dr. Aldo R. Castenada of the Harvard-affiliated Children's Hospital, might have been employed with more success.

Bailey claimed that the drastic condition of Baby Fae before the operation led him to believe that a time-consuming search for a suitable human heart would simply cost Baby Fae her life. "We did not search for any human hearts before the operation," he says in a press statement. The Loma Linda Medical Center however has refused to make public either the data on Baby Fae herself, or the deliberation before conducting the operation. "The hospital regards all information on Baby Fae as private," says Jessical Baker, spokesperson.

"They should have actively searched for a human replacement," says Mudge. "Common sense would dictate that we should exclude all conventional methods before venturing into the relatively undocumented field of species-to-species transplants."

"If I could not find a human heart to serve as a replacement, I probably would have let the baby die in peace rather than subject her to unprecedented [for neo-natals] experimentation," added Mudge.

In addition, Dr. Castenada has used a modified version of the Norwood procedure on about 40 children with about a 40 percent mortality rate. Xenographic transplants in history have a 100 percent mortality rate; Baby Fae outlived all other recipients of an animal heart by two and a half weeks.

Baby Fae's condition could possibly have been corrected by the Norwood operation, says Castenada. He emphasized that unless Bailey had developed some novel technique for supressing the immune system after the transplant he would be critical of the doctor for ignoring other methods.

Bailey, who prior to this operation was not a leader in the organ transplant field, has not published any information on xenographs or on transplants in general for that matter, according to the press office.

"I certainly would have used the Norwood methods," says Levey, a colleague of Castenada.

In addition to raising questions of the appropriateness of species-to-species transplants, the Baby Fae case has brought some long-avoided issues of medical ethics into the public realm. Once again, however, more questions than answer have been brought up.

Animal-rights activists across the nation have come out in droves to denounce the operation as "useless" and "goulish tinkering." Also, several doctors and government officials have called for increased regulation of new procedures given the suddenness and uncensured nature of Bailey's operation.

"We were very displeased with the whole situation at Loma Linda," says Aaron Medlock, executive director of the New England Anti-Vivesectionist Society. "We feel a great deal for Baby Fae because she was used, just as the sacrificed baboon, as an animal in an experiment. The public just doesn't understand that the operation did not take place for the benefit of Baby Fae, but for the benefit of researchers."

"She probably wouldn't have lived any longer without the baboon heart but now they're both dead," he says. He added that very rarely does a doctor have to make a life or death decision based on killing an animal for the sake of a human being. "Seventy million animals die every year in experiments and almost none of these deaths save the life of a human."

In addition, he says that if the medical profession devoted more of its time to reforming the system for donor organs from humans (increasing the number who pledge their organs upon death) then the need to kill animals would be minimized.

Medical researchers, however, have convincing arguments for the need to use animals. "You can't name a significant medical advance in the last fifty years which hasn't used animals in experimentation to a certain extent," Tilney explains. He says that sacrifices are necessary for the continued progress of medical science.

"We all have dogs at home," but medicine has always relied on animals for experimentation, the alternative being people, says Mudge.

Cohn agreed however that significant reform in the human donor process would help to solve the reliance on other methods of saving lives including the use of animals. "Thousands of people die everyday with perfectly good organs," he says.

Yet another question arises around the self selection of physicians to perform the controversial transplants. Several transplant specialists--many doctors at Harvard affiliated hospitals among them--have questioned whether doctors like Bailey, who are relatively unknown and unpublished, should be allowed to conduct such dangerous and widely-publicized operation on a child.

Bailey says he had consulted the parents of Baby Fae and "completely informed them of all other possibilities to save their child's life." And the Loma Linda Ethics Board, made-up of citizens and doctors, reviewed and gave approval to the operation, says spokesperson Baker.

State medical regulators, however, criticize these informal processes as archaic. "Bailey is in the forefront on technology but he is 30 years behind on guidelines," says Jogan M. Georga, special assistant for medical planning in the Massachusetts State Health Department.

If the operation were to take place in this state, Bailey would have had to apply for a certificate of need (CON), she says. "We would have asked: will the operation take money and time away from patients who stand a much better chance of survival? Is it too expensive? What would be the quality of life afterwards? What would all the drugs do to her tiny body?"

Georga says to her knowledge no such forum took place at Loma Linda. "No such novel operation should happen in a suprise manner as it did there," she says.

A Boston University professor goes further in calling for special guidelines for transplants on children. Professor of Health Law George T. Annas, who headed up a task force earlier this month which set the guidelines for heart transplants in Massachusetts, advocated a more widespread use of the Nuremberg code of ethics for human experimentation. "There should be absolutely no risky experiments performed on children until the same experiments have been successfully applied to adults," he says.

The medical ethics expert lebels Bailey's work on Baby Fae "child abuse."

Annas added that unreasonable operations should be strictly forbidden. "Everyone gave up, on xenograph transplants ten years ago, and I have found no new literature to suggest any improvement in the technique."

He added that Bailey's peers haven't had the chance to review his work, a process vital to good medical practice. "Bailey's work boarders on the reckless-he won't tell us anything and we suspect the worst."

But Dr. Joseph Vicanti, assistant professor of medicine and administrator of transplant operations at Children's believes that doctors are out to do their best for the community. "I am not in favor of further regulation because it layers things and stifles creativity. In situational review is enough."