Inhaled hexamethonium, the drug implicated in the recent death of Ellen Roche, a previously healthy 24 year old woman who volunteered in an asthma study at Johns Hopkins University, Baltimore, Maryland (BMJ 2001;322:1565), may have made subjects ill in experiments 23 years ago.
Researchers at the University of California in San Francisco are re-examining data from a 1978 study on the basic physiology of asthma in the wake of Ms Roche's death.
Dr Alkis Togias, the principal investigator and designer of the Johns Hopkins study, reportedly relied in part on earlier work done at the University of California in San Francisco in arguing the safety of inhaled hexamethonium. Like his study, the earlier study used inhaled hexamethonium to induce bronchoconstriction and simulate asthma.
Two of five test subjects in the Californian study became ill during the experiment, but their illnesses were not ascribed at the time to the inhaled irritant and therefore went unreported.
According to the university, one participant in the study presented to the university hospital's emergency department four days after inhaling hexamethonium with complaints of dyspnoea and tightness in the chest. The patient described his participation in the research experiment to the examining physician, but his symptoms were diagnosed as compatible with viral pneumonia.
The second participant complained of headache and malaise and withdrew from the study. Neither of the participants died. The side effects, though easily overlooked, were similar to those of volunteers in Dr Togias's asthma study at the Johns Hopkins University.
▪ The Office for Human Research Protections has agreed research involving humans may go ahead at Johns Hopkins University if it is in the “best interests” of the subjects involved. Researchers have to submit a summary of their project's protocol and justify its continuation. Any new research involving humans must meet strict criteria.