The Hexamethonium asthma study ^(1,2)

In 2001, Ellen Roche, a healthy volunteer, died from progressive decline in lung function after inhaling hexamethonium in a study conducted at John Hopkins University. The drug was used to test the mechanisms of asthma through the inducement of mild asthma symptoms in non-asthmatics.

Her death inquiry revealed several shortcomings that led to suspension of this study as well as many other studies conducted by the university.

Among the findings were that the investigator and the institution’s research ethics committee:

• Failed to identify literature that documented the detrimental effects of inhaling hexamethonium. These publications were readily found through web searches, but the investigator only conducted a Pubmed search which unfortunately did not cover records from the 1950s.
• Were not critical about the four previous trials that were cited as safety evidence for hexamethonium – these studies only had 20 subjects altogether, hence too small to pick up any side effects reliably.
• Failed to realise that the research would require prior approval from the drug control authority (U.S. Food and Drug Administration (FDA)), since hexamethonium had never been approved to be given via an inhalation route.

Savulescu and Spriggs described this case in their paper ‘The hexamethonium asthma study and the death of a normal volunteer in research’ (2002).