Perspectives On Medical Research

Volume 2, 1990

Baby Fae: The Unlearned Lesson

Kenneth P. Stoller, MD.

On October 26, 1984, Dr. Leonard L Bailey placed the heart of a baboon into the chest of Baby Fae, an infant born with a severe heart defect known as left hypoplastic heart. Baby Fae seemed to do well for a few days; then her body mounted a massive immunological attack on the foreign tissue and rejected the graft. Baby Fae's death came as no surprise to scientists and physicians familiar with the human immune system and with the scientific realities that preclude successful cross-species transplants.

Before the Baby Fae incident, Bailey, a surgeon at Loma Linda University Medical Center, spent almost a decade vainly pursuing research grants. His work in xenografts, largely unknown and unrcviewed by other professionals, had not appeared in journals and was funded by Bailey himself and his colleagues.^1,2 During the seven years preceding the Baby Fae baboon transplant, he performed some 160 cross-species transplants, mostly on sheep and goats, none of whom survived more than 6 months. Although warned by a colleague at a medical conference that his research was too incomplete to risk using human subjects,³ Bailey went ahead.

Baby Fae was not the first human to receive a primate xenograft. In a review of xenografts,⁴ the Council of Scientific Affairs of the American Medical Association noted a rapid rejection of all baboon transplants to humans. Nevertheless, Bailey claimed that the problems of rejection could be overcome by the "immature" state of an infant's immune system. After the operation, immunologists from around the world pointed out that the part of the immune system that rejects unmatched transplants is fully mature at birth, Furthermore, there is no way to match baboon hearts to human recipients, because baboons have no antigens in common with human tissue.⁵ Bailey has always maintained that Baby Fae's death was unrelated to the species of the organ "donor." An editorial in the Journal of the American Medical Association called Bailey's claim "wishful thinking."⁵

Bailey's use of baboons was somewhat surprising, given their relatively distant evolutionary relationship to humans compared to other primates. The reason came to light when the Times of London published an interview between Bailey and an Australian radio crew. The reporters had been forbidden to ask direct questions about the operation, so they queried Bailey on the issue of why he had chosen a baboon in view of the baboon's evolutionary distance from humans. Bailey replied, "Er, I find that difficult to answer. You see, I don't believe in evolution."⁶ It is shocking that Bailey ignored basic biological concepts in formulating a life-threatening human experiment.

Often, ambitious surgeons wish to perform new, perhaps dangerous, experimental operations. In an effort to safeguard patients, institutional review boards must first give permission for any human experiment. In an unconscionable lapse of ethics, the review board of Loma Linda Medical Center failed to live up to its obligations -- they gave Bailey permission for five baboon-to-human transplant experiments, having no reports documenting that even heart allotransplantation in infancy is successful.⁵ Furthermore, highly experimental procedures on children, such as a xenograft, require special permission from the Secretary of Health and Human Services.⁷

In addition to these institutional and federal safeguards that should have protected Baby Fae, California's Protection of Human Subjects in Medical Experimentation Act (PHSMEA) requires that if informed consent is given in behalf of another person, the experimental procedure must meet certain criteria. California's Health and Safety Code ~24175, subsection (e) states, "Informed consent given by a person other than the human subject shall only be for medical experiments related to maintaining or improving the health of the human subject or related to obtaining information about a pathological condition of the human subject."

Because Bailey did not look for a human heart donor and did not refer Baby Fae elsewhere for attempted surgical repair, the highly experimental transplant was both unethical and unlawful. Dr. William Norwood at the Children's Hospital in Boston has been repairing left hypoplastic hearts since 1979. The survival rate of the Norwood procedure is now as high as 75 percent Nevertheless, Baby Fae's consent form read, "Temporizing operation to extend the lives of babies like yours by a few months have generally been unsuccessful. We believe heart transplantation may offer hope of life for your baby. Laboratory research at Loma Linda University over the past seven years, including over 150 heart transplants in newborn animals, suggest that long term survival with appropriate growth and development may be possible following heart transplantation during the first week of life."

Following considerable controversy over the Baby Fae transplant, the National Institutes of Health (NIH) appointed a special committee charged with reviewing the procedures used by the university to assure that Baby Fae's relatives gave proper informed consent. The committee did not deal with the scientific basis for transplanting a baboon heart into a human. The committee found several weaknesses in the consent procedure. Specifically, the committee concluded that possibility of "long term survival" had been overstated and the protocol did not include searching for or transplanting a human heart. The committee's report did not address why Loma Linda had not sought permission for this unprecedented experiment from the Secretary of Health and Human Services. Furthermore, it did not address the California law that should have prevented the experiment. (Perhaps the NIH committee was unaware of PHSMEA.)

Why hasn't Bailey been prosecuted? The San Bernandino District Attorney's office has officially stated that there are insufficient facts to support a felony prosecution. Unofficially, I was told that the highly technical nature of the case would likely overwhelm the court with conflicting medical opinions and therefore make a conviction unlikely. Furthermore, Bailey is considered a local hero. The office of the California State Attorney General, John K. Van de Kamp, has also maintained that Sufficient facts are available to establish that a crime occurred.

The facts, however, suggest that Baby Fae was sacrificed to Leonard Bailey's career. Given the state of current medical knowledge, there was no doubt that Baby Fae would reject the baboon heart. Rules and laws designed to protect her were violated by those entrusted to uphold them. Professional ethics were considered to be of less importance than widespread publicity. The institutional review boards and law enforcement agencies responsible for protecting human subjects have virtually no accountability to the public, much less to the experimental subjects themselves.

References

1. Anon: Next please. PCRM Update, July-August, 1985.

2. Roe BR, Glaser RH: The lessons of the Baby Fae Case (letter). The Wall Street Journal Dec 24, 1984.

3. Mathews J: Colleague warned doctor before Baby Fae implant. Washington Post, 1984.

4. American Medical Association Council on Scientific Affairs: Xenografts: Review of the literature and curreut status. JAMA l985;254:3353-3357,

5. Jonasson O, Hardy MA: The case of Baby Fae (letter). JAMA 1985;254:3358-3359.

6. Gould SJ: The heart of erminology What has an abstruse debate over evolutionary logic got to do with Baby Fat? Natural History 1988;97:24.

7. Department of Health and Human Services: Final regulations amending basic HIHS policy for the protection of human research subject. Federal Register 1981;465:8366-8392.

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