Hepatitis Study Concern

Beecher’s article sent ripples of concern through both the medical world and the general public as news of the article spread through the mass media. This public concern translated into pressure on Congress and on the U.S. Public Health Service (PHS), at the time the nation’s major funder of medical research. To demonstrate to Congress that it could handle the problem itself and to keep public concern from turning into budget cuts, the PHS in 1966 published guidelines for protecting human subjects in medical research.

The Willowbrook Hepatitis Study Concern about medical research was fur- ther heightened when the Willowbrook hepatitis story and the Tuskegee syphilis study burst into the news in the early 1970s. Willowbrook State School, run by the state of New York, was an institution for mentally retarded children. Conditions in Willowbrook were horrendous, with children routinely left naked, hungry, and lying in urine and excrement. As a result, hepatitis, a highly contagious, debilitat- ing, and sometimes deadly disease, ran rampant among the children and, to a lesser extent, the hospital staff.

In 1956, to document the natural history of hepatitis and to test vaccinations and treatments, two pediatrics professors from New York University School of Medicine began purposely infecting children with the disease. In addition, to test the effectiveness of different dosages of gamma globulin, which the researchers knew offered some protection against hepatitis, they injected some children with gamma globulin but left others unvaccinated for comparison. The children’s par- ents had consented to this research but had received only vague descriptions of its nature and potential risks.