The Ellen Roche story
Free Online Scholarship (FOS) Newsletter
August 23, 2001
by Peter SuberEllen Roche was a healthy 24 year old lab technician at the Johns Hopkins (JH) Asthma Center. She volunteered to take part in an experiment to understand the natural defenses of healthy people against asthma. Roche was part of a group that inhaled hexamethonium, a drug which induced a mild asthma attack. Physicians stood by in case of complications and to measure how the subjects responded to the asthma attack. Within 24 hours of inhaling the drug, Roche had lost one-third of her lung capacity. Within a month she was dead.
The consent form she signed warned of coughing, dizziness, and tightness in the chest, but not death. It called hexamethonium a "medication" although its approval by the FDA (as a treatment for high blood pressure) had been withdrawn in 1972.
Here's the FOS connection: Dr. Alkis Togias, the director of the experiment, apparently limited his hexamethonium research to one contemporary textbook and PubMed.
The use of hexamethonium in the 1950's to treat high blood pressure created an evidentiary trail revealing some disturbing risks. Several articles published in print journals during the 1950's showed that hexamethonium could cause fatal lung inflammation. Unfortunately, PubMed's coverage starts in the mid-1960's. When the FDA withdrew its approval of hexamethonium in 1972, it cited the drug's "substantial potential toxicity". Unfortunately, PubMed covers medical research, not FDA rulings.
The JH internal investigation found literature on the dangers of hexamethonium in Google and Yahoo. Medical librarians who subscribe to the MedLib listserv found relevant information in online sources other than PubMed.
At least one expert witness has already zeroed in on the sloppiness of the research. Quoting Dr. Frederick Wolff, professor emeritus at the George Washington School of Medicine: "This is just laziness. What happened is not just an indictment of one researcher, but of a system in which people don't bother to research the literature anymore."
Ellen Roche died on June 2, and the Roche family has apparently not yet filed a lawsuit. However, JH still faced a serious sanction. On July 19 the federal Office for Human Research Protection (OHRP) suspended all JH research on human subjects. This halted 2,400+ ongoing experiments with 15,000+ human subjects. The disruption was administratively chaotic, devastating to research, and potentially grave for patients participating in experiments who suddenly found their medication withheld. Perhaps for this reason the OHRP lifted the suspension three days later, though with the requirement that experiments meet new safeguards.
What does this case imply about PubMed and FOS generally in high-stakes research? See the next item below for some comments.
Eva Perkins, Johns Hopkins' Tragedy: Could Librarians Have Prevented a Death?
Report of FDA investigation
Report of Johns Hopkins internal investigation
MedLib listserv postings on searching online for hexamethonium risks
PubMed
In writing this report, I also relied on these stories from the Baltimore Sun:
[Thanks to Denise A. Troll for bringing this case to my attention.]
* Postscript. JH is not out of the woods yet on the ethics of experimenting on human subjects. The Maryland Court of Appeals has just ruled that JH researchers violated informed consent rules when they deliberately exposed healthy children from low-income families to lead. The result was a measurable increase in the level of lead in their blood. The experiment was approved before the Roche case erupted, but the court ruling was delivered only last week.
Dan Curry, State Court Denounces Johns Hopkins-Approved Study That Exposed Children to Lead Dust
Maryland Court of Appeals decision (August 16, 2001)
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Newsletter, archived back issues
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Conferences Related to the Open Access Movement
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Timeline of the Open Access Movement
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Open Access Overview
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Peter Suber
http://www.earlham.edu/~peters
peter.suber@earlham.edu
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