Welcome to the Free Online Scholarship Newsletter
August 23, 2001
Introducing the Guide to the FOS Movement
I'm very pleased to announce that I've finished the first draft of my Guide
to the FOS Movement. This is a guide to the terminology, acronyms,
initiatives, standards, technologies, and players in the movement to
publish scholarly literature on the internet and make it available to
readers free of charge.
Now that it's online, I can revise, enlarge, and update it, which will be
much easier than writing the present draft. I welcome your suggestions. I
have about 30 entries waiting to include, but don't hesitate to report
omissions. I also welcome corrections and comments of any kind.
The guide has many purposes. It should help you find background on
unexplained terms or names you encounter in research on any FOS-related
topic. For the same reason, it will allow me to use terms and names here
in the newsletter without explaining each one every time. Above all, it
should make it easier for specialists from one sector (e.g. research,
libraries, publishing) to understand the contributions to this movement
made by specialists from other sectors. This movement isn't only
multi-disciplinary, encompassing all the academic disciplines, but also
multi-industrial, drawing on libraries and universities and such varied
economic sectors beyond the academy as publishing, telecommunications,
software engineering, philanthropy, and government. It is also
multi-national, building on the work of individuals and organizations from
around the world. Without special study one cannot appreciate the
contributions of all these players to the FOS movement. I hope the guide
brings recognition to the contributors and understanding to those hoping to
see the big picture.
Guide to the FOS Movement
http://www.earlham.edu/~peters/fos/guide.htm
--
The Ellen Roche story
Ellen 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?
http://www.infotoday.com/newsbreaks/nb010806-1.htm
Report of FDA investigation
http://www.fda.gov/ora/frequent/483s/JohnHopkins483.html
Report of Johns Hopkins internal investigation
http://www.hopkinsmedicine.org/press/2001/JULY/r
