The Willowbrook hepatitis studies

Willowbrook State School on Staten Island was a New York institution for children with intellectual disabilities. It was overcrowded, conditions were unsanitary, and hepatitis was endemic. Saul Krugman, chairman of pediatrics at New York University, led studies of the natural history and prevention of hepatitis there with Joan Giles. Krugman dated their start to 1955; other accounts give 1956, and they ran into the early 1970s. The Armed Forces Epidemiological Board, which funded the work, and NYU's executive faculty approved it.

Newly admitted children, aged 3 and older, were given material from infected patients, including processed feces and serum, and were kept in a separate research unit. Some also received gamma globulin and some did not. In 1967 Krugman, Giles and Jack Hammond reported two distinct types of infection, which they called MS-1 and MS-2. MS-1 matched classical infectious hepatitis, now hepatitis A. MS-2 matched serum hepatitis, now hepatitis B, and against the accepted view it proved moderately contagious. In 1969 the group linked MS-2 to the Australia antigen, and in 1971 they reported studies of immunization against it.

Krugman defended the work on three grounds: the children would catch hepatitis at Willowbrook anyway, the disease was milder in children, and parents gave informed consent. Critics disputed each point. In 1964 the school closed to new admissions because of overcrowding, but parents received letters offering places in the hepatitis program, and parents often gave permission because it meant admission. Henry Beecher included one of the studies among the examples in his 1966 article on unethical research in the New England Journal of Medicine. In 1971 Stephen Goldby wrote to the Lancet that it was wrong to experiment on a child when no benefit could come to that child, and the journal's editors accepted the criticism of their earlier coverage.

Krugman set out the history and his case again in a 1986 review. Later, Joel Howell and Rodney Hayward of the University of Michigan used his published data to estimate that a child's chance of infection at Willowbrook outside the study was between 30 and 53 percent. Some ethicists still defend the studies; the Oxford Textbook of Clinical Research Ethics argues that misguided criticism of them has hampered research in children.