Recent quotes:

The Horrors of Hepatitis Research | Carl Elliott | The New York Review of Books

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.

ER patients given ketamine in clinical trials without their consent, FDA finds - STAT

Their report, obtained by Public Citizen through a public records request and shared with STAT, examined additional clinical trials beyond those initially flagged. It found that in four, the hospital IRB “did not determine that informed consent would be sought from each prospective subject” as required by law, while in another five, the IRB granted fast-track review to studies that didn’t qualify for it. At least three of the studies cited by the FDA inspectors involved people brought to the emergency room with “severe” agitation, as assessed by emergency technicians using criteria developed by the researchers. The study leaders apparently persuaded the IRB that such patients could not provide informed consent, and so could be swept into the trial unknowingly. In fact, such patients are considered “vulnerable,” said bioethicist Leigh Turner of the University of Minnesota, who signed the Public Citizen letter. According to federal law, they are supposed to receive special safeguards, such as having a family member or other representative give or decline consent. That did not happen.