1978 Study Had Troubles Like a Fatal Hopkins TestJul 25, 2001
Two healthy volunteers in a 1978 asthma study at the University of California at San Francisco fell sick, one seriously enough to be treated at a hospital, after inhaling the drug that led to the death of a young woman in a similar research project at Johns Hopkins University last month.
In a statement released today, officials at the University of California in San Francisco said the problems had not been reported in the published description of the experiment because the researchers had strong reasons to believe that the problems were unrelated to the drug, hexamethonium.
The earlier study was used as evidence by the researcher in the Hopkins experiment that inhaling doses of hexamethonium was safe.
Because of the death of the Hopkins volunteer, Ellen Roche, officials at the San Francisco university said doubts had arisen among researchers in the original study as to whether the problems had been caused by hexamethonium. As a result, the officials said, they have opened a new review of the earlier work.
"We 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," said Zach Hall, executive vice chancellor for the San Francisco university.
Dr. Homer A. Boushey, a researcher at the university who was involved in the earlier study, said three of the five members of the original research team inhaled hexamethonium themselves, with no ill effects, before giving it to half a dozen volunteers.
One of those volunteers complained of a headache and general malaise and withdrew from the study, today's statement said, but researchers concluded the reaction was probably caused by a different drug in the study. But after completing the study, another volunteer reported to an emergency room with chest tightness and shortness of breath.
Eventually, doctors outside the study concluded the second volunteer was probably suffering from viral pneumonia. He was treated with a common antibiotic and his condition gradually improved.
Dr. Boushey said that regulations at the time did not require reporting such events, and that in any case, the doctors' reports had convinced him that the reaction was unrelated to hexamethonium. But today, he said the death at Hopkins had sown new doubt in his mind.
Despite the new review in San Francisco, Dr. Boushey said, "I still actually do not know if what transpired in 1978 was a reaction to hexamethonium."
"I do not," he repeated.
The revelations raise the question of whether Ms. Roche's death could have been avoided if the earlier problems had been reported. The researcher who designed the asthma study in which Ms. Roche died on June 2, Dr. Alkis Togias, used Dr. Boushey's paper as his principal evidence that hexamethonium was safe to inhale in large doses - about one gram in both studies.
"If in fact a very serious adverse lung event that required hospitalization occurred and was reported in the 1979 study," said Daniel Kracov, a lawyer for Dr. Togias, "it is unlikely that any of the researchers in the later hexamethonium studies, including the study at Johns Hopkins, would have undertaken their research."
In the wake of the death, the federal government last week suspended all federally financed medical research involving human subjects at Johns Hopkins Medical Institutes. It lifted the suspension this week, but required that nearly all of the research be intensively reviewed again.