Asthma Research Death at Johns Hopkins Under Investigation
HHS' Office for Human Research Protections, which "oversees the safety of federally funded research studies," launched an investigation last week into the death of a Johns Hopkins School of Medicine lab technician who died earlier this month while participating in an asthma study, the Baltimore Sun reports. Ellen Roche, age 24, died June 2 after "taking part in an experiment" sponsored by the NIH which was "designed to help doctors understand a healthy person's natural defenses against asthma." The medical school has now suspended the experiment (Pelton et al., Baltimore Sun, 6/16). Previously healthy, Roche developed a fever, flu-like symptoms and inflammation in the right lung two days after taking the drug hexamethonium, a medication once used to treat high blood pressure and reduce bleeding during surgery but "is no longer used in therapy." The Sun reports that it is unclear whether this drug "triggered" her death. Two other study subjects were given hexamethonium -- one reported coughing that "soon cleared up," while the other reported no side effects (Bor et al., Baltimore Sun, 6/15).
On Saturday, Hopkins released a "detailed description" of the study and the consent form given to volunteers before they were accepted. The form did not warn of any "life-threatening" side effects and said a "doctor would be present to treat the patient if problems arose." Regarding hexamethonium, the medical school said that the drug could reduce blood pressure or cause dizziness, and that "[a]s a safeguard, volunteers would be hooked up to a heart monitor and have their blood pressure monitored" (Baltimore Sun, 6/16). The New York Times reports that a spokesperson for hexamethonium maker Fluka, a Swiss subsidiary of the St. Louis-based Sigma-Aldrich Corporation, said that the drug "was not generally intended for human use and that he could not immediately find any record that Johns Hopkins had been provided human-grade material." But Joann Rodgers, a spokeswoman for Johns Hopkins, called it "'standard practice' to use chemicals labeled not intended for human use if they had received FDA approval for experimental testing, as was the case for hexamethonium" (Altman, New York Times, 6/16). The Sun reports that the Office for Human Research Protections has a "range of options" in an investigation, including "suspend[ing] ... an entire research program until corrections are made" (Baltimore Sun, 6/15).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.