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Following the death of a healthy 24-year-old research volunteer, federal regulators forced Johns Hopkins University in Baltimore to halt all research on human subjects. The university was allowed to resume its research under strict oversight, but many questions remain about the oversight process that allowed the volunteer’s death.
A Johns Hopkins internal review committee chaired by Lewis Becker, MD, reported that Alkis Togias, MD, had not submitted an Investigational New Drug application to the Food and Drug Administration (FDA) for using hexamethonium as an inhalant. Once used as an intravenous antihypertensive, hexamethonium is no longer on the FDA’s list of approved drugs.
The Johns Hopkins committee points out that hexamethonium has been used as an inhalant in several lung function studies without incident, but it concluded that the Institutional Review Board (IRB) should have asked Togias for an opinion from the FDA about the use of the drug. The death of the young, healthy woman has led to a barrage of criticism against Johns Hopkins’ oversight of its physicians and their research.
Ellen Roche died after taking part in an asthma study in which she inhaled hexamethonium to assess its effect on the lungs. Within a month, she died of progressive hypotension and multi-organ failure. The FDA already has cited Togias for what it says was a failure to disclose the woman’s adverse reaction. In addition, the FDA cited Togias for failing to seek the agency’s approval prior to conducting the clinical trial, as well as changing the study protocol without permission from the IRB. Togias did not return a call seeking comment.
Furthermore, the Hopkins committee says the volunteer was not fully informed of the risks involved in the study. The committee concludes that the informed consent form signed by Roche and other healthy volunteers was "inadequate" and "should not have been approved" by the IRB.