June 13, 2001
MEDIA CONTACT: Joann Rodgers
Johns Hopkins officials report, with deep regret, the recent death of a volunteer research subject. The exact cause of death has not been determined.
The study for which this person volunteered was funded under an NIH Grant with the title "Lung Inflation and Airways Hyperresponsiveness." The study was a baseline physiological test using inhaled hexamethonium to find out how an important function of the lung, that protects the airways from narrowing, works. This function plays a critical role in the development of asthma. A pool of volunteers participates regularly in research studies such as this one.
Johns Hopkins, whose institutional review boards approve all studies using human subjects, including this one, suspended the study after this event was reported. Hopkins also notified the Office of Human Research Protections, the U.S. Food and Drug Administration and the National Institutes of Health of the occurrence of this event.
Hexamethonium, a drug that lowers blood pressure, was long used to treat hypertension and decrease bleeding during surgery. The drug also has been used in several clinical research studies at leading academic medical centers looking at lung physiology without any reported unexpected adverse events.