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Public Citizen Renews Call for Suspension of Reckless Sepsis Trial

Public Citizen News / May-June 2019

By Rhoda Feng

This article appeared in the May/June 2019 edition of Public Citizen News. Download the full edition here.

In April, Public Citizen renewed its call for termination of a deeply flawed clinical trial involving seriously ill sepsis patients. This time, the call was made after a news report revealed that the National Institutes of Health (NIH) obstructed its own employees from helping with a federal ethics probe into the major ongoing NIH-funded trial.

According to The Wall Street Journal, senior NIH officials, including Principal Deputy Director Lawrence A. Tabak, explicitly forbade two senior scientists at the agency’s Clinical Center from communicating with the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (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. After news broke that the NIH had muzzled two of its own scientists, Public Citizen called for an investigation by the HHS Inspector General into the conduct of the senior NIH officials involved in kneecapping the federal ethics probe of the trial.

A major public health challenge

Sepsis is a life-threatening condition caused by the body’s response to an infection, causing shock and organ failure. Certain people with infections have a high risk of developing sepsis, including older adults, infants, individuals who have compromised immune systems and individuals with chronic medical conditions (such as diabetes).

Sepsis is the second most common reason for hospitalization in the United States and the most expensive condition treated in hospitals, accounting for nearly $24 billion in annual hospital spending. Sepsis also kills more than 250,000 Americans every year, which is more than the number of American deaths due to breast cancer, prostate cancer and acquired immune deficiency syndrome combined.

The CLOVERS trial

In the CLOVERS trial, which began in 2018, patients are 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.

“The reported actions by senior NIH officials to muzzle its own scientific experts 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.”

As of press time, 45 institutions are running the trials, and CLOVERS researchers plan to enroll up to 2,320 subjects by the trial’s projected completion in March 2021. In addition to advocating a halt to the CLOVERS trial, Public Citizen has called for a moratorium on any other National Heart, Lung, and Blood Institute-funded clinical trials that test interventions in critically ill subjects until the multiple systemic breakdowns that permitted CLOVERS to be approved are fully understood and corrected.