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Two critical care physicians at the National Institute of Health (NIH) are being prevented by agency leadership from speaking to government investigators, who are exploring concerns around a large NIH-funded clinical trial, according to a report yesterday in The Wall Street Journal. The two physicians had raised concerns that the trial, which is testing treatments for the life-threatening blood infection sepsis, was putting patients at risk.
Last year, the watchdog group Public Citizen in Washington, D.C., sent a letter raising concerns about the sepsis trial to the Office for Human Research Protections (OHRP) within the Department of Health and Human Services, NIH’s parent agency. Public Citizen stated that it had sought expert advice from the two NIH physicians, Charles Natanson and Peter Eichacker, in assessing the trial, and had concluded it posed “unacceptable risks” based on that assessment. In particular, Public Citizen charged that the study, Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS), which began to recruit patients last year to test two novel sepsis treatments, didn’t include a control arm for the usual standard of care, putting participants at heightened risk of harm.
Wall - Street - Journal - Reports - OHRP
The Wall Street Journal reports that OHRP then “launched...
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