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Report on Clinical Trial Volunteer's Death
16 July 2001 7:00 pm
BALTIMORE, MARYLAND--Seven weeks ago, a young lab technician at Johns Hopkins University in Baltimore died after volunteering to participate in a clinical study of asthma (ScienceNOW, 19 June). Today the university gave out a 32-page internal report on the case and answered a barrage of questions from the press. "We will never know the exact cause of her death," said Edward Miller, the CEO of Johns Hopkins Medicine and dean of the medical faculty. But he added: "We accept full institutional responsibility" for the tragedy.
The inquiry concluded that Ellen Roche's fatal reaction was probably triggered by a chemical used in the trial called hexamethonium bromide, which is not approved for clinical use by the Food and Drug Administration (FDA). She was only the third volunteer at Hopkins to inhale this chemical; the first volunteer developed a short-lived dry cough, and the second reported no problems. But Roche responded differently. Miller said the alveolar sacs of her lungs, which transfer oxygen into the blood, were irreversibly damaged. She was slowly asphyxiated between 4 May, when she inhaled hexamethonium, and 2 June, when she suffered multiple organ failure.
The report points to a distinctive aspect of Roche's exposure: Her dose of hexamethonium was delivered by a more powerful spray mechanism than used for the first two volunteers, to shorten the procedure. This might have delivered a higher concentration, the report says. The inquiry panel examined whether lead researcher Alkis Togias and the university's Institutional Review Board (IRB) had done an adequate job of researching the hazards. The panel found that Togias's literature review was "standard," although it failed to turn up reports of lung toxicity from 1953-70 among seriously ill patients who had taken hexamethonium intravenously. But the panel faulted the IRB for not being more demanding in its review of the proposed trial.
The panel found no evidence that Roche or other volunteers had been coerced into participating. But it disclosed that eight of the nine volunteers who signed up were employees of the Hopkins Asthma Center, which conducted the trial. When asked if employees were expected to volunteer as part of their work, Lewis Becker, chair of the inquiry panel, responded firmly that they were not.
Miller announced that Hopkins intends to add a third IRB to the two it already maintains. Plans are also under way for a stem-to-stern review of clinical operations. And all trials run by Togias as well as 16 others employing chemicals not approved by FDA for clinical use, have been suspended. "We will have to raise the bar [for clinical research] even higher," Miller said.