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HHS Ethics Office Should Suspend Sepsis Trial Until NIH Interference With Probe Ends and Inquiry Is Completed

Agency Also Should Demand Inspector General Investigation of Misconduct by Senior NIH Officials, Public Citizen Says

The U.S Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) should suspend a clinical trial involving seriously ill sepsis patients, known as the CLOVERS trial, until the National Institutes of Health (NIH) allows two scientific experts at the NIH Clinical Center to speak to OHRP staff and the ethics office has completed its compliance oversight evaluation of the trial, Public Citizen said today in a letter to the agency.

The letter follows a Wall Street Journal report that found senior NIH officials forbade the two scientific experts from communicating with the OHRP about the reckless CLOVERS trial, despite a direct request from the OHRP to speak to these scientists about the trial.

The office also must immediately demand a formal investigation by the HHS Inspector General into the conduct of the senior NIH officials involved in obstructing the federal ethics probe of the trial by muzzling the two scientists, the letter said. Public Citizen on Monday called for an HHS inspector general investigation as well.

“OHRP should have taken these actions months ago. Its lack of action represents a serious failure of leadership by the office and erodes public trust in the agency,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group.

Read the letter here.