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Inspector General Must Investigate NIH’s Obstruction of a Probe of Unethical, Reckless Sepsis Trial

Public Citizen Demands Answers Following Bombshell Wall Street Journal Report

WASHINGTON, D.C. – The federal government must investigate a news report documenting that the National Institutes of Health (NIH) prevented its employees from helping with a federal ethics probe into a clinical trial involving seriously ill sepsis patients, Public Citizen said today.

The U.S. Department of Health and Human Services (HHS) Office of Inspector General must investigate the actions taken by NIH senior officials to muzzle the agency’s own scientific experts, thereby effectively interfering with the HHS Office for Human Research Protections’ (OHRP’s) compliance oversight evaluation of alleged ethical and regulatory lapses involving a major ongoing NIH-funded sepsis clinical trial, Public Citizen said in a letter (PDF) to the federal watchdog.

The letter follows Sunday’s report by The Wall Street Journal that senior NIH officials, including Principal Deputy Director Lawrence A. Tabak, the top deputy to NIH Director Francis Collins, explicitly forbade Dr. Charles Natanson and Dr. Peter Eichacker, two senior scientists at the agency’s Clinical Center, from communicating with the OHRP about the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial, despite a direct request from the OHRP to speak to these scientists about the trial.

Public Citizen filed a complaint with the OHRP in August 2018, with publicly disclosed input from the two scientists, who are internationally recognized sepsis and critical care medicine experts, demanding that federal regulators halt the unethical sepsis trial.

In the CLOVERS trial, patients are being given one of two risky experimental treatments for sepsis, neither of which is therefore considered standard treatment. Because no other group of patients in the trial is receiving the usual treatment for sepsis, researchers are unable to ensure that the experiment isn’t causing increased deaths and organ failure. Sepsis is a life-threatening condition caused by serious infections that leads to shock and organ failure.

“The reported actions by senior NIH officials constitute gross misconduct and corruption at the highest levels of the NIH, tantamount to an obstruction of ethical justice for the subjects of the trial,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “To avoid blatant conflicts of interest as the funder of the trial, NIH must have no role in determining with whom OHRP staff speak when investigating the research.”

The Wall Street Journal reported that the OHRP has “launched a federal review of the conduct of the [CLOVERS] trial and sought to interview Drs. Natanson and Eichacker.” Tabak confirmed to the newspaper that “he prohibited the two doctors from answering questions from OHRP investigators” and that “Dr. Collins was aware of [this] decision.” The newspaper also noted that the Council of the Assembly of Scientists, an internal NIH committee of 24 doctors and researchers representing the scientists on the NIH campus, wrote a memo to Tabak telling him “that they were ‘extremely concerned’ that the two doctors ‘have been forbidden by NIH leadership to respond to OHRP, either as an official duty activity or an outside activity.’”

“These actions of the NIH leadership undermine the protections for human subjects who are enrolled in NIH-funded research and, ultimately, erode public trust in NIH,” said Carome. “Restoring that trust will necessitate a change in leadership at NIH.”