UCSF 1978 Study Didn’t Report Outcomes in Research Similar to Johns Hopkins Asthma Study
Researchers who conducted a 1978 University of California-San Francisco study involving the drug hexamethonium -- the same substance that caused the June death of a participant in a Johns Hopkins University asthma study -- did not report that two volunteers in the study became ill, one "seriously," after inhaling the substance, UCSF officials announced yesterday. The New York Times reports that the 1978 study was cited by the lead researcher in the Hopkins study, Dr. Alkis Togias as the "principal evidence that hexamethonium was safe to inhale in large doses," and yesterday's "revelations raise the question of whether" the death of Ellen Roche "could have been avoided if the earlier problems had been reported." UCSF officials said that the events at Hopkins, which led to the Office of Human Research Protections ordering a temporary suspension last week of all human research at the university, created "doubts" about the conclusions of the researchers involved in the 1978 study, who determined that the problems suffered by the study participants were not related to hexamethonium. According to a statement released by UCSF yesterday, three of five members on the research team inhaled the substance "with no ill effects." Six volunteers then received the drug: one suffered a headache and withdrew from the study, but the researchers concluded that it was "probably caused by a different drug in the study;" a second volunteer suffered chest tightness and shortness of breath and went to the emergency room. The Times reports that "eventually doctors outside the study concluded that the volunteer was probably suffering from viral pneumonia," and he was treated with an antibiotic and his condition "gradually improved."
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Zach Hall, executive vice chancellor of UCSF, said that the
university has organized a review of the study and will
"pull together all the information that we can find about this and will make some judgment about what the interpretation of those events might be in hindsight." Dr. Homer Boushey, a UCSF researcher who helped conduct the 1978 study, said that regulations at that time did not mandate the reporting of adverse events and that doctors' reports had "convinced him" that hexamethonium had not caused the illness. He added, however, "I
still actually do not know if what transpired in 1978 was a
reaction to hexamethonium." Togias' attorney, Daniel Kracov, pointing to his clients' use of the UCSF study in determining the safety of the substance, said, "If in fact a very serious adverse lung event that required hospitalization occurred and was reported in the  study, it is unlikely that any of the researchers in the later hexamethonium studies, including the study at Johns Hopkins, would have undertaken their research"
(Glanz, New York Times, 7/26).