In academic medicine, as with Confederate statuary, the mighty are starting to fall. The names of physicians once celebrated for ethically questionable research are finally being removed from medical school buildings, awards, and lectureships. In 2008 the University of Pittsburgh discontinued a lecture series named for John Cutler, one of the principal researchers in the Tuskegee syphilis study from 1932 to 1972 and the Guatemala syphilis study of the mid-1940s. Ten years later it removed the name of Thomas Parran, another Tuskegee researcher, from a building in its School of Public Health. In 2021 the University of Pennsylvania took similar measures with Albert Kligman, the dermatologist responsible for decades of barbarous experiments at Holmesburg Prison in Philadelphia, renaming the Kligman Professorship and phasing out a lectureship named after him. A movement is now underway at the University of Cincinnati to honor those who died in the Pentagon-funded radiation experiments conducted there in the 1960s and early 1970s by Eugene Saenger, a radiologist honored by the university with the Daniel Drake Medal, the College of Medicine’s highest honor.
Of all the infamous research scandals that emerged in the 1960s and 1970s, however, none is more contested than the one over the Willowbrook hepatitis study. Between 1956 and 1972 a team of researchers from New York University led (beginning in 1958) by Saul Krugman deliberately infected institutionalized, mentally disabled children at the Willowbrook State School on Staten Island with the hepatitis virus. Along with the Tuskegee syphilis study and the 1963 cancer study at the Jewish Chronic Disease Hospital in Brooklyn, Willowbrook is part of what the historian Susan Reverby calls the bioethics “holy trinity” of research horror stories. Yet Krugman was widely celebrated among his peers. The year the study ended, he was elected president of the American Pediatric Society. Later he was honored with some of medicine’s most prestigious prizes, including the Robert Koch Gold Medal (1978), the John Howland Award (1981), and the Mary Woodard Lasker Public Service Award (1983). Even today Krugman has defenders. The Oxford Textbook of Clinical Research Ethics argues that misguided criticism of the Willowbrook study has “cast a restrictive ethical pall” over pediatric research.1
Like most scholars in bioethics, I was taught that the Willowbrook hepatitis program first became a matter of public controversy in 1966 when one of the studies was singled out in “Ethics and Clinical Research,” Henry Beecher’s famous broadside in The New England Journal of Medicine. Beecher, a prominent anesthesiologist at Harvard Medical School, named twenty-two examples of medical research that he thought were ethically indefensible. Example 16 was one of Krugman’s hepatitis studies at Willowbrook. In Beecher’s account, researchers had intentionally infected “mentally defective” children with the hepatitis virus in an institution where hepatitis was endemic. “There is no right to risk an injury to one person for the benefit of others,” he wrote.
Accounts of the Willowbrook study in many bioethics textbooks and articles present it as a difficult ethical problem with sound arguments on both sides.2 The most inflammatory issue, of course, was the deliberate infection of disabled children. There was no reason the research couldn’t have been done on consenting adults. Critics also charged that the parents had given consent for their children’s participation in the study under duress. The Willowbrook State School was so crowded that the only way many families could gain admission for children was to enroll them in the hepatitis program.
Krugman mounted a strong defense, arguing that hepatitis was such an enormous problem at Willowbrook that the children there would have contracted it anyway, regardless of whether they participated in his study. He also wrote that hepatitis is usually mild in young children and that all the subjects in the study were housed in a special, well-staffed unit where they were protected against other infectious diseases.3 A person reading many accounts of the Willowbrook program today could conclude that the moral outrage over it in the 1960s and 1970s had been overblown.
That would be a mistake. Anyone tempted to dismiss criticism of the hepatitis program should see the documentary film Willowbrook: The Last Great Disgrace (1972), an investigation into conditions at the school. It is like seeing the body cam footage from a police shooting after years of only reading police reports. Howls and moans come from poorly lit rooms. Naked children smeared with their own feces rock back and forth on concrete floors. Some are in straitjackets, while others are curled up on the floor crying. Many appear malnourished and have visible physical deformities. At mealtimes attendants use large spoons to shovel white paste into the children’s mouths. Michael Wilkins, a physician fired for organizing Willowbrook parents to demand better conditions, speaks softly about what the children endure: “Their life is just hours and hours of endless nothing to do, no one to talk to, no expectations—just an endless life of misery and filth.”
I don’t know what I imagined when I first read the clinical accounts of the Willowbrook hepatitis study, but it didn’t include disabled children lying naked in puddles of their own urine. A high school study guide produced by the Department of Bioethics at the National Institutes of Health says that “specialized facilities with expert services were often seen as the best places for mentally disabled children, and parents were eager to get their children into them, including Willowbrook.”4 The NIH does not mention the stench of filthy bathrooms, the mayhem of screaming children on unattended wards, or the allegations of sexual abuse. How someone visiting Willowbrook for the first time could have seen it as a research opportunity rather than a moral atrocity is hard to fathom.
Yet these gruesome conditions are not all that is absent from standard accounts of the study. For decades no one questioned Krugman’s crucial claim that virtually every child at Willowbrook would invariably contract hepatitis within six to twelve months. Over time, however, it has become clear that infection with hepatitis at Willowbrook was far from inevitable. Nearly twenty years ago, using Krugman’s published data, Joel Howell and Rodney Hayward at the University of Michigan showed that the likelihood of infection at Willowbrook outside of Krugman’s study was actually somewhere between 30 and 53 percent.5 Those figures make Krugman’s study look far more harmful. Yet many bioethics textbooks still repeat his claim. Even those that use the corrected figures often give Krugman the benefit of the doubt, assuming that he genuinely believed that the children were certain to be infected with hepatitis in any case.
Even more alarming is another omission from the standard account. In most textbooks, the debate about Willowbrook centers on the infection of children with hepatitis A, or what was known in the 1950s as “infectious hepatitis.” Hepatitis A is an unpleasant but often relatively mild disease that results in jaundice and fatigue as well as abdominal symptoms such as nausea, pain, loss of appetite, and diarrhea. It is transmitted by the so-called fecal-oral route and is often associated with food poisoning and unsanitary conditions. During World War II researchers had shown that infectious hepatitis was distinct from “serum hepatitis,” what is now known as hepatitis B, a much more dangerous disease transmitted through the exchange of blood or bodily fluids.
Some bioethics texts, such as the guide distributed by the National Institutes of Health, specifically identify the Willowbrook program as a study of hepatitis A. Others simply say “hepatitis,” leaving readers to assume hepatitis A from the context.6 Yet Krugman also deliberately infected children with the hepatitis B virus. This required an injection rather than the “fecal milkshake” used to transmit hepatitis A. The dire risks of hepatitis B were not unknown in Krugman’s time; other hepatitis researchers had injected subjects with it and seen them die. Nor could Krugman defend himself with the claim that his subjects would have gotten hepatitis B anyway. It was not endemic at Willowbrook. Krugman wrote in 1986, “During the course of our epidemiologic survey in 1955, all of the evidence indicated that the endemic disease was so-called infectious or type A hepatitis, an infection that spread via the fecal-oral route.”
Deliberately infecting institutionalized, disabled children with the hepatitis B virus is an abuse of stunning proportions. Hepatitis B infection can lead to chronic hepatitis, resulting in cirrhosis, liver cancer, and death. It is even more dangerous in children than it is in adults. According to the Department of Health and Human Services, 2–6 percent of adults infected with hepatitis B will go on to develop chronic hepatitis, while for children under the age of nineteen the likelihood of chronic infection is 30 percent. In addition, unlike those infected with hepatitis A, between 6 and 10 percent of young adults infected with hepatitis B become carriers capable of passing the potentially lethal virus on to others. This became an issue for some parents who took their infected children out of Willowbrook and tried to enroll them in public schools, only to be informed by school authorities that they were a risk to other children.
How bioethicists could have misunderstood the Willowbrook hepatitis research for so long is a mystery. The controversy over it helped establish bioethics as an academic field. It was considered in a 1969 issue of the journal Daedalus, “Ethical Aspects of Experimentation with Human Subjects.” It was one of the scandals that triggered the 1974 National Research Act, which established the current system of protecting human research subjects. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research discussed Willowbrook in its 1978 report “Research Involving Those Institutionalized as Mentally Infirm.” Yet none of these publications mentions the true horrors of the Willowbrook story.7
In her chilling book, Dangerous Medicine: The Story Behind Human Experiments with Hepatitis, Sydney Halpern shows that Willowbrook was only one piece of a much larger and more sinister research program. For thirty years American researchers conducted hepatitis “challenge studies,” deliberately infecting a variety of vulnerable subjects with hepatitis A, hepatitis B, and even (unknowingly) hepatitis C. Mentally disabled children were not the only victims. The researchers also infected psychiatric patients, prison inmates, and draft objectors. More than 3,700 subjects, all of them living in institutional settings, were enrolled in the hepatitis experiments. More than eight hundred of them were children. As many as 25 percent were African American. “I know of no series of problematic infectious disease studies that involved a wider array of devalued and stigmatized groups,” Halpern writes. She estimates that the researchers transmitted blood-borne hepatitis to more than one thousand people.
The hepatitis research program had its origins in World War II. The US military was hit by an enormous hepatitis B outbreak within four months of the Pearl Harbor bombing. By the summer of 1942 approximately 28,000 members of the military had contracted hepatitis and sixty-two of them had died. The speed at which the virus spread shocked military commanders. By the end of 1942 the number of infected personnel had grown to more than 300,000. An investigation soon revealed the cause: soldiers were being given a contaminated yellow fever vaccine. Military officials tried to cover up the mistake, but news of so many deaths and illnesses proved impossible to suppress. “How did it happen that wholesale inoculations were undertaken with a vaccine which quite obviously had not been thoroughly tested in advance?” asked an editorial in the Chicago Tribune in July 1942, noting that the number of vaccine victims was over twenty times the number of soldiers wounded in the war.
One might imagine that government physicians would be chastened by a disaster of this scale. But neither the mistake nor the public criticism of it prevented researchers from launching a research program into hepatitis transmission. They had plenty of contaminated yellow fever vaccine, and the war gave them the excuse of urgency. Halpern writes that it was “a scientific opportunity too promising to forgo.” Soon the researchers were using their contaminated vaccine to make subjects sick, hoping to learn more about how hepatitis was transmitted.
They started with mentally disabled patients in Virginia. In 1942 the Virginia State Colony for Epileptics and Feebleminded housed roughly two thousand inmates. The Lynchburg Colony, as it is commonly known, eventually became notorious for its eugenics program, in which over eight thousand were involuntarily sterilized. But Halpern also shows that a Public Health Service (PHS) research team led by John Oliphant gave contaminated yellow fever vaccines to 303 Lynchburg Colony inmates, sickening forty-four of them with hepatitis B. In publications about the research, Oliphant failed to mention that his subjects were mentally disabled. He called them “volunteers.”
The Lynchburg Colony experiments were the first in a systematic federal research program into hepatitis. Two federal offices managed most of the contracts: the Office of Scientific Research and Development and the Armed Forces Epidemiology Board (AFEB). The researchers were a combination of PHS physicians, federally funded university researchers, and medical officers in the military. Military concerns shaped the conduct of the research. When asked to balance the risks and benefits of a study, researchers typically placed national security interests well above the rights and welfare of their subjects.
Others followed the pattern established in the Lynchburg Colony. In the spring of 1944, for instance, Joseph Stokes of the University of Pennsylvania began virus transmission experiments with “criminally insane” inmates at Trenton Psychiatric Hospital. Aware that experimenting on institutionalized psychiatric patients would be controversial, Stokes took pains to conceal the studies, advising New Jersey officials to treat them as a war secret. Conscientious objectors to the war who served as laboratory technicians and ward attendants were deeply disturbed by what they saw and raised objections with hospital authorities in 1945. Despite their protests, the hepatitis studies continued for eight more years.
In 1947 an ethical barrier to the hepatitis program emerged. Responding to the barbarous experiments on humans carried out in Nazi concentration camps, American judges on the postwar “Doctors’ Trial” at Nuremberg of twenty-three German physicians and administrators issued a set of ethical principles known as the Nuremberg Code. Often considered the most important document in the history of biomedical research ethics, the Nuremberg Code laid the groundwork for today’s principles aimed at protecting the rights and welfare of research subjects. It should have been obvious to any American hepatitis researchers who bothered to read the code that they were violating it. Yet instead of slowing down, between 1946 and 1954 they experimented on over three times as many subjects as they had during the war.
The deadliest episode in the hepatitis program came in the early 1950s, at the beginning of the Korean War. The hepatitis B virus had contaminated the supply of blood for transfusions, and researchers were looking for a way to inactivate it. They tried sterilizing blood with ultraviolet rays, heat, and chemicals. To test whether the blood was safe, they injected it into prison inmates. It wasn’t. Large numbers of inmates contracted the disease, and three died of fulminant hepatitis. Another was comatose for a week before recovering.
For the duration of the hepatitis program, government officials refused to compensate subjects who were sickened or injured in its studies. In one case, it even barred a Quaker organization from buying health insurance for research subjects. The government usually provided medical care for subjects who became ill during the studies, but once a study was over, the subjects were on their own. If someone was killed in a study, the family received no compensation. For example, when an African American inmate at Jackson State Prison died of fulminant hepatitis, government attorneys refused to compensate his common-law wife.
Of all the studies in the thirty-year hepatitis program, only the Willowbrook experiments are widely remembered. Krugman and his associate, Joan Giles, admitted approximately forty-eight children a year into their hepatitis research unit, most of them between three and ten years of age. When children were finished as research subjects, they were moved to a regular Willowbrook ward. The Armed Forces Epidemiology Board was deeply involved in all decisions about the research. When outsiders condemned the Willowbrook studies, AFEB scientists mobilized support from academic medical leaders. Halpern writes, “In response to criticism of the Willowbrook experiments, America’s biomedical elite circled the wagons.”
For decades, circling the wagons worked. By the early 1970s, however, the public was no longer willing to accept the assurances of men in white coats with advanced degrees. Willowbrook was only one of a series of alarming research scandals that came to light between 1971 and 1973, each of them involving a powerless and easily exploited research population: military radiation experiments on low-income cancer patients at the University of Cincinnati, deep brain stimulation on psychiatric patients at Tulane University, a range of terrifying experiments on prison inmates as reported by Jessica Mitford in The Atlantic Monthly, and most notoriously the forty-year Public Health Service program in Alabama now known as the Tuskegee syphilis study, in which some four hundred African American men with syphilis were left untreated so that researchers could study the progress of the disease.
When Michael Wilkins started work as a physician at Willowbrook, it was not because he needed the job. It was because he suspected that terrible things were happening there. Wilkins had joined the Public Health Service after medical school, mainly because it looked like a good alternative to military service in Vietnam. On Staten Island he had joined a group of radical health care workers called the Fanon Collective, named after Frantz Fanon, the psychiatrist and political philosopher from Martinique who wrote The Wretched of the Earth. Another member, Bill Bronston, was a conscientious objector and activist who had been dismissed from a residency in Kansas after organizing a union.
Wilkins and Bronston went to work at Willowbrook with the aim of cleaning it up. It didn’t take long to discover that no one else shared that aim—not the physicians, not the nurses, not any of the other staff. The only ones responsive to their efforts were a handful of social workers and the parents of the Willowbrook children, who were largely unaware of the horrific conditions behind the institution’s locked doors. Along with the sympathetic social workers, Wilkins and Bronston began meeting with parents to help them protest conditions there. As a result, Wilkins, along with the social worker Elizabeth Lee, was fired in January 1972.
When Wilkins lost his job he went to Geraldo Rivera, then a young civil rights lawyer turned television journalist. Wilkins and Rivera had worked together at a New York City medical clinic set up by the civil rights organization the Young Lords to treat children with lead poisoning. Wilkins told Rivera why he had been fired. “In my building there are sixty retarded kids, with only one attending to take care of them,” he said. “Most are naked and they lie in their own shit.” Rivera went to Willowbrook with Wilkins and a camera crew. The stunning footage that aired on the local news that evening became part of Willowbrook: The Last Great Disgrace. Rivera later compared the scenes to what American GIs found when they liberated Nazi concentration camps.
Rivera’s broadcast ignited a spark that eventually brought Willowbrook down. Emboldened parents began to organize. The national media picked up the story. John Lennon held a benefit concert at Madison Square Garden. When the American College of Physicians presented Saul Krugman with an award for his hepatitis research at its 1972 annual meeting in Atlantic City, demonstrators shouted protests, and some of them attempted to storm the stage. In March 1972 the New York Civil Liberties Union and Legal Aid Society filed a class action lawsuit on behalf of Willowbrook parents; in 1975 a consent decree required the state to create community placements for Willowbrook residents. In 1987 Willowbrook finally closed its doors.
Halpern finished Dangerous Medicine in the midst of the global Covid-19 pandemic. Within weeks of the pandemic’s arrival in the United States in 2020, she notes, commentators were already advocating for human challenge studies on the new virus. Their arguments invoked the same utilitarian logic and language of noble sacrifice used by Krugman and his fellow cold war hepatitis researchers. As earlier with hepatitis, the risks and long-term consequences of infection with SARS-CoV-2 were largely unknown. If the advocates of Covid-19 challenge studies were aware of the hepatitis program or its terrible costs, their arguments showed no sign of it.
How many subjects died as a result of being infected with hepatitis is impossible to know. No one was tracking their health after the studies finished, when the long-term effects of hepatitis B or C may have appeared. Nor was anyone keeping track of who the subjects may have unknowingly infected. The hepatitis researchers simply created what Halpern calls “a pool of hepatitis carriers at risk for slowly simmering, life-threatening liver diseases.”
Yet of all the crimes sanctioned by the hepatitis program, the one that seems to bother Halpern most is the refusal of the federal government to compensate the families of the research subjects it sickened or killed. This policy is difficult to defend on ethical grounds, yet it remains in place today. In fact, most American research institutions refuse to guarantee payment for the medical bills of injured subjects, even if the injury was caused by negligence, ill intent, or malpractice. This refusal sets the United States apart from every other developed country in the world. As Halpern writes, “These injuries remain uncounted and unexamined; they are the largely invisible underbelly of America’s experiments with human subjects.”
It has become a tradition for academic medicine to celebrate its triumphs and bury its crimes, only to see them exhumed decades later by an academic or a journalist with a nose for scandal. Halpern’s extraordinary achievement in Dangerous Medicine stands alongside those of Susan Reverby, the Wellesley College historian who uncovered the Guatemala syphilis study; Allen Hornblum, who documented the medical atrocities committed at Holmesburg Prison; and Eileen Welsome of The Albuquerque Tribune, who exposed the US government’s secret cold war radiation experiments. The work of those three investigators has resulted in apologies to the victims and, in the cases of the Guatemala and radiation experiments, apologies from US presidents. So far, however, Halpern’s work has been met only with silence.
English (US) · 