Clinical Trial Exposed Some Subjects to Substandard Care for Life-Threatening Prolonged Seizures Without Informed Consent

WASHINGTON, D.C. — A National Institute of Health (NIH)-funded clinical trial involving patients with life-threatening prolonged seizures was deeply flawed and must be immediately investigated, Public Citizen said today in a letter to the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) following an analysis of the trial.

For the Established Status Epilepticus Treatment Trial (ESETT), researchers in emergency departments at 58 hospitals across the U.S. enrolled 462 children and adults suffering an episode of status epilepticus — a seizure lasting longer than five minutes — that had not resolved after standard initial treatment with a benzodiazepine and randomly assigned them to receive one of three FDA-approved seizure medications intravenously: levetiracetam, fosphenytoin, or valproate. The goal was to determine which of the three drugs would result in better seizure resolution and responsiveness within 60 minutes after initiation of the assigned drug.

“The troubling flaws in ESETT’s design exposed some of the subjects to unacceptable and avoidable risks and thus violated regulatory and ethical norms for human research,” said Michael Carome, director of Public Citizen’s Health Research Group and author of the letter. “These lapses are even more disturbing in light of the fact that subjects were enrolled without providing informed consent.”