A medical watchdog group is calling on the National Institutes of Health to immediately stop the enrollment of patients in a clinical trial of sepsis treatment and launch an investigation of how the study received approval, arguing that it puts patients at risk of serious harm, including death.
The group, Public Citizen, says in a letter dated Tuesday that the study’s protocol is also so “fundamentally flawed” that it will not produce reliable findings.
The problems with the “CLOVERS” study are so serious that “it is difficult to imagine any reasonable person agreeing to enroll … if he or she were fully informed of [its] true nature and risks,” wrote Dr. Sidney Wolfe and Dr. Michael Carome of Public Citizen’s Health Research Group. They contended that patients in the trial are “unwitting guinea pigs in a physiology experiment that will not advance medical care for sepsis,” and that other lapses are “stunning in their breadth and scope.”
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