Advocacy Group Urges HHS to Halt Sepsis Trial

Public Citizen, a national consumer advocacy group, is urging the federal government to halt an ongoing clinical trial involving ill sepsis patients. The group alleges that the trial is “deeply flawed, riddled with serious regulatory and ethical lapses, and must be stopped,” according to a statement released this week.

Public Citizen claims the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial is dangerous because patients are being given one of two treatments for sepsis, both of which are risky and neither of which is considered standard treatment. No other patients in the trial are being given the usual sepsis treatment, so researchers can’t ensure the experiment isn’t causing increased deaths and organ failure.

“The design of this disturbing trial is more akin to an experiment that would be conducted on laboratory animals,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, in the release. “These human subjects are unwitting guinea pigs in a physiology experiment that will not advance medical care for sepsis and likely will harm many.”

The group is urging the U.S. Department of Health and Human Services’ Office for Human Research Protections to immediately end CLOVERS, which is being funded by the National Heart, Lung, and Blood Institute (NHLBI) through its Prevention and Early Treatment of Acute Lung Injury Network. Sixteen institutions are running the trials, including Ronald Reagan UCLA, University of Colorado Hospital, Cleveland Clinic Foundation, Beth Israel Medical Center, and Vanderbilt University Medical Center, according to the release. Other institutions are slated to be study sites. Researchers plan to enroll up to 2,320 subjects by the trial’s projected end date in March 2021, the group says.

Public Citizen says the experimental treatments expose many patients to unacceptable dangers. The usual course of care for early sepsis patients involves doctors adjusting the doses of intravenous fluids and blood pressure-raising medication based on patient needs. In CLOVERS, according to Public Citizen, half of the sepsis patients receive predominantly IV fluids and the other half will receive predominantly blood pressure-raising meds. The lack of a third group being given the usual care means researchers can’t adequately determine if either of the experimental treatments is too unsafe to continue using.