“To find out, scientists led by Dr. Alkis Togias of Johns Hopkins University had Roche and other healthy volunteers inhale a drug called hexamethonium.”
“The consent form that Roche signed states nowhere that hexamethonium is not approved by the FDA (the form describes it as a "medication") and didn't warn about possible lung toxicity.”
“After a three-day inspection last week, OHRP concluded that the Hopkins scientists failed to get information on the link between hexamethonium and lung toxicity, even though data were available via "routine" Internet searches and in textbooks.”
“The review board, OHRP charges, never asked for data on the safety of inhaled hexamethonium in people.”
“Institutional Review Boards (IRBs) that may be In 2001, Ellen Roche, a volunteer in a phase I easily generalized to other settings: study at Johns Hopkins University, died after an experimental inhalation of hexamethonium. 21 Two Membership - Who should sit on an ethics com - major ethical lapses have been suggested.”
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