Asthma Study Leads to Death

The Associated Press reports on July 20, 2001 that after an improperly administered asthma study at Johns Hopkins University in Baltimore, MD caused the death of a healthy, 24 year-old participant, all human research at the school has been suspended by the U.S. Office of Human Research Protection(OHRP). The research ban was lifted on July 23, 2001 after weekend meetings resolved the OHRPs concerns.

Study participant Ellen Roche, 24, died on June 2, 2001 after inhaling the drug hexamethonium, which was being used to induce asthma attacks in healthy people so doctors could learn how the body fights asthma attacks. Hexamethonium was widely used in the 1940s and 1950s in tablet form for the treatment of hypertension but the U.S. Food and Drug Administration (FDA) later pulled its approval of the drug. Hexamethonium was never approved by the FDA to be used as an inhalant.

In a letter to the school that outlined the reasons for the suspension, the OHRP says that researchers did not sufficiently warn participants in the asthma study of the dangers and "continued to expose additional subjects to inhaled hexamethonium before the symptoms in the first subject were resolved and before reporting the event" to a university review board.

The University's own internal review of the incident stopped short of blaming the lead researcher, Dr. Alkis Togias, who remains on staff and faces no other disciplinary action. The same review went on to conclude that the experiment was "well-supervised". By way of commentary, we feel that Ellen Roche would likely disagree with that conclusion.