“Unusual Care”: Groupthink and Willful Blindness in the SUPPORT Study

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Taylor & Francis




The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. Citation2013) attack the study’s methodology itself in this issue, arguing that even on its own terms SUPPORT was fatally flawed (Macklin and Natanson Citation2020). Specifically, they argue that one arm of the study (the low oxygen arm) was not followed anywhere and could not be reasonably considered “standard care,” but was rather “unusual” and therefore experimental care (Cortes-Puch et al. Citation2016; Macklin and Natanson Citation2020). They also make useful suggestions about how to prevent future mischaracterizations of “usual care.”

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