Johns Hopkins troubles raise trial questions

Hopkins University has resumed under severe restrictions imposed by the US Office of Human Research Protection (OHRP). The disciplinary actions came after the death in June of an otherwise healthy volunteer who participated in an asthma study. Meanwhile, the University of California at San Francisco (UCSF) will reexamine a 1978 study in which two research volunteers became sick after inhaling the same drug that presumably led to the death of the Johns Hopkins volunteer, 24 year old Ellen Roche. At the time of the UCSF study, lead investigators did not report the volunteers' illnesses because they did not believe they were linked to the drug. " The committee on human research is now looking at the study to see if there is anything that we can learn from it retrospectively. I do not know how long that will take, " says Alice Trinkl, spokesperson for UCSF. The drug used in both studies is hexamethonium, which blocks a class of receptors on sympathetic ganglion neurons. The drug was used as a high blood pressure medication in the 1950s and 1960s, but was taken off the market in 1972. A number of articles published in the 1950s reported that the drug could induce severe lung toxicity and even death in some patients. Alkis Togias, lead investigator of the study at Johns Hopkins, planned to administer hexamethonium to healthy volunteers to block certain bronchial nerve ganglia and thereby investigate the neuronal mechanisms that protect the lungs of healthy individuals from asthma attacks. A university review committee that investigated the study concluded that volunteer Ellen Roche most likely died from adult respiratory distress syndrome as a result of exposure to the drug. The committee criticised the internal review board (IRB) that approved the study for not requiring more evidence of safety in the use of hexamethonium (both Togias and the IRB apparently failed to look up the 1950s articles warning of lung damage). According to the committee's report the consent form signed by the research volunteers was 'inadequate in the description of the research risks.' In addition, committee members said that Dr. Togias should have promptly reported to the IRB that a previous volunteer in the study had Death on trial: Johns Hopkins University is the latest center to suffer major problems in the running of a drugs trial amongst healthy volunteers. The death is leading to concerns about the procedures established to oversee …