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.
Have you stopped to consider the countless lives Dr. Bailey saved? How about the first infant human to human heart transplant? He also maintains a relationship with Baby Faes mother! He also saved my sons life and repaired his heart. Why hasnt Bailey been prosecuted? Instead of that question I thank God he wasnt. My son has a chance at life because of our local hero.
XENO HISTORY:
1628: Sheep blood transfused to humans in Padua, Italy.
1682: Bones from dog’s skull transplanted into head of wounded soldier.
1800’s: Sheep blood injected into wayward husbands and troublemakers in England to make them calm, or at least sick. Skin cut from living frogs and put on human burns and ulcers. Size of graft was determined by the wriggling of the frogs trying to escape.
1906: Princteau’s failed attempts to transplant rabbit kidney sections into humans.
1910: Ernst Unger puts monkey kidneys into a human. They failed, as did his transplanting a kidney from a stillborn baby into a Baboon.145
1913: Serge Voronoff transplants chimp thyroid into boy aged 14. Failed.
1914: Sheep’s blood transfused to wounded soldiers.
1914: Bone transplant from animal to wounded soldier in France by Russian surgeon Serge Voronoff.146
1920-1923: Serge Voronoff does a series of testicle transplants from monkeys and chimpanzees to elderly men who reported renewed vigour.147 His achievement was celebrated on ashtrays engraved with little jokes about improved performance.
1923: Neuhof transplanted a sheep kidney into a human patient who died nine days later.
1958: First successful heart transplant, from one dog to another, by Norman Shumway in the United States. Shumway was a superior surgeon to Christiann Barnard and had more concern for his human patients. He was capable of beating Barnard to the first human heart transplant but knew that organ rejection would kill the recipient and was reluctant to proceed until that problem was more understood.
1963: Keith Reemtsma of the United States transplanted a chimpanzee kidney into a human patient who lasted 63 days. Another one lived nine months with the kidney operating for six.
1964: Dr James Hardy of Mississippi did the first heart transplant from a chimpanzee into a human. The hospital allowed the consenting relatives to believe the new heart would be from a human. You can imagine the surprise when they discovered their child got a chimp’s heart. The kid died during surgery.148
1965: Tom Starzl, aka Tom FrankenStarzl, did six baboon-to-human kidney transplants. All kidneys survived hyperacute rejection but were destroyed within two months from human immune system attacks. One set of kidneys produced fifty litres of urine in 24 hours, which killed the patient.149
1966 to 1973: Tom Starzl transplanted three livers from chimpanzees to children. All died within fourteen days.
1968: Denton Cooley in Houston, Texas transplanted a sheep’s heart into a human patient. Donald Ross in London, England transplanted a pig’s heart into another human. Both hearts were attacked within minutes by the patient’s immune systems and they died.
1977: Christiaan Barnard transplanted two chimpanzee and baboon hearts to humans as auxiliaries until their own hearts could recover. The chimpanzee heart was rejected after four days. The baboon heart wasn’t big enough to support circulation. Both patients died when their own hearts failed to recover.
1984: Dr Leonard L. Bailey, of Loma Linda Seventh-day Adventist Hospital in California, put a Baboon heart into a baby girl called Fae. The kid lasted twenty days. Dr Bailey said it gave him good practice. The hospital got 75 complaints about cruelty to Fae and 13,000 for the Baboon. Leonard Bailey was advised to wear a bulletproof vest. It was ironical that a church specialising in vegetarianism would be a leader in human and xeno transplanting.
1992: Pig heart to human performed in Sosnowiec, Poland. It failed and the patient died.
1993: Leonard Makowka put a pig liver into a human. It failed.
1992 and 1993: Tom Starzl did two baboon to human liver transplants. Both patients died. One lived seventy days. Protesters picketed his house calling him Tom FrankenStarzl. The name stuck.
1996: Pig heart transplanted into a human in India. Patient died and the surgeon was jailed. When he got out he said he was going to do more.
Many of the facts in this are wrong or skewed so that it will support your position. For instance in 1984 the Norwood Procedure was very unsuccessful. Today it’s quite successful, however, this was not the case in 1984. A human heart was not sought because there was no viable way to get an infant heart for transplant in 1984 (an infant heart transplant had never been done before). Thanks in large part to Baby Fae organ donations have gone up and procurement agencies are much better.
Thank you for the info. Corrections and additions always accepted warmly. Appreciate it!
My sons life was saved by Dr.Bailey and his team 15 years ago. He had several heart defects and was in cardiac arrest at 10 days old from these anomalies. I see a lot of judgement on these comments but I wonder if any are from a mother or father who have held their dying child in their arms? I watched the life fade from my childs face and body and remember almost hitting the floor when a nurse picked me up and carried me outside. He was gone for a second or more~ enough to let me know I would never see him breath again. Luckily, GOD himself handed him back to us through Dr. Baileys hands. I think until you have personally held your own dying child, your opinions should be kept to yourself. I am truly a God fearing and loveing Christian woman and I beleive that all knowledge is God given. How else would this MAN hold life in his hands as he does everyday?
Seeing this list of failed attempts with human and animal lives, I wonder which SICK motives does a doctor has when suggesting this xeno-transplantation. This baby Fae incident should never happened. But I guess doctor thing themselves gods. I cannot believe that a church supported this. Well religious people have already lost their minds.
I can’t believe that doctor’s would do an inter-species transplant knowing it does not work. Crazy. Poor Roberta, I’m guessing they did not stick a baboon heart in her kid because the child’s life was saved. If they had stuck a baboon heart in her kid, the child would have died and Roberta probably would have written something else. Also, you don’t need to hold your dying child to have an opinion. Roberta did, so she believes that her and her alone has an entitlement to opinion on the matter. I think I’ll agree with all the other doctor’s of the world who simply understand the inter-species heart transplants where one side is human just does not work. So don’t do it. Hind sight is 20/20. In the end, they will say…”Oh yeah, what were we thinking, we should have tried transplanting a human heart instead of a baboon’s. That might have worked better since monkey hearts don’t work in humans.”
It also must be nice believing God gave you back your child. Now you are validated by having the Host of Host’s stop his busy schedule to save your child that day, but not the thousand’s of other children that died that very same day.
I’ve never held a dying child, nor would I allow a doctor to put a baboon heart in my child. I also think that the people involved in this, doctors and media, as well as the people like Roberta, are all crazy. Some big mass hysteria that has taken over and allowed people to act with out any reason. I’m so glad my parents did not let doctor’s try that crap with me when I was a child and unable to speak up for myself.
Came across your post. I suggest you do some more research on the status of transplantation research at that time. While you knock Leonard Bailey, he was running state-of-the-art HLA typing (maybe MHC would be better). There was current research suggesting the infant immune system would be naive and subsequent research supported him. In truth, there were published opinions both ways. I won’t compile a complete set of references but here’s one part of the controversy. http://www.nejm.org/doi/full/10.1056/NEJM200103153441102
Of course immunology has advanced greatly in the last 20 years but with some of the modern tolerance inducing drugs xenobiotic transplants may even make a comeback.
I am a close relative to “Baby Fae”. I totally agree with this article written by Kenneth Stoller MD. Tragic indeed. Our family never left the hospital. We camped out in the hospital waiting room. No question he used her as an opportunity to conduct his own experiment which the article clearly conveys.
I cannot believe all the negative comments being said about Dr. Leonard L Bailey. I’m another one of his patients, and everyday I thank him for volunteering to perform my surgery. Without him, my life would have been shortened by more then half. He’s a beautiful caring man whose saved many lives.
Shame on any of you calling him a monster!