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.
The Wall Street Journal reports that OHRP then “launched a federal review of the conduct of the clinical trial, and sought to interview Drs. Natanson and Eichacker. NIH Director [Francis] Collins’s top assistant, Principal Deputy Director Lawrence A. Tabak, confirmed he prohibited the two doctors from answering questions from OHRP investigators.” (Neither physician is involved in the trial.)
Natanson has long spoken out against large clinical trials funded by his employer that recruit critically ill patients—sometimes in conjunction with his colleague Eichacker. Natanson’s targets have included a study of ventilator use that was suspended by OHRP in 2003 before being allowed to resume; a study of oxygen support in babies, which OHRP also investigated and against which Natanson testified; and more recently, an NIH trial to treat more than 3000 heart attack patients called the Myocardial Ischemia and Transfusion trial. In all of these cases, as in the CLOVERS trial, Natanson has argued that the trial’s design puts patients at a too-high risk, or otherwise comes with serious flaws.
It is not clear when OHRP will conclude its review of the CLOVERS trial. In the meantime, recruitment of patients continues, with a goal of more than 2000 people.
In a statement, NIH said the agency “has management discretion to assign employees to particular tasks based on their assigned, official duties, and will immediately assign appropriate staff to work with OHRP if OHRP seeks NIH expertise on this matter."
Update, 30 April 2019, 9:34 a.m.: This story has been updated to include a statement from NIH.