Johns Hopkins Takes Blame for Death
July 16 -- When lab worker Ellen Roche, 24, offered herself as a test subject for an asthma study, she couldn't have known it would kill her.
Today, Johns Hopkins University took responsibility for her death, tentatively attributed to exposure to a drug she inhaled as part of the study.
A preliminary report by the Baltimore-based university said Roche's death resulted from her participation in the study, conducted by researchers at Johns Hopkins Hospital, recently named the top U.S. hospital by U.S. News and World Report.
"The precise cause is likely to remain uncertain," said medical school Dean Edward Miller today, announcing the report. He said the university accepts "full institutional responsibility for her death." The study was funded under a National Institutes of Health grant.
On May 4, Roche inhaled the drug — which restricts airways — as part of her participation in the study. Five days later she was admitted to Johns Hopkins Bayview Medical Center in Baltimore, experiencing a dry cough and breathing problems. Her condition deteriorated and Roche died June 2 of multiple organ failure.
The study, by inducing asthmatic symptoms in healthy lungs, was intended to help doctors learn how the body fights asthma. Hexamethonium was used to induce the symptoms to investigate a specific function of the lungs.
Roche worked as a lab technician in the Johns Hopkins Asthma andAllergy Center.
Johns Hopkins' Alkis Togias, head researcher of the study, has been suspended from doing other studies.
A report by the Food and Drug Administration earlier this month said Togias "failed to report an unanticipated adverse event," a persistent cough, in another volunteer.
Further, Togias didn't initially ask the FDA for permission to have volunteers inhale drugs that would trigger asthma-like reactions in their lungs, and changed how volunteers received the drug during the study without notifying anyone, the report said.
The university today said the dangers of the inhalant "should have been included" in the consent form given to research participants. The dangers of hexamethonium were not included in the consent form that Roche and others signed.
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