Government suspends human subject
A School of Medicine review committee investigating the
death of a research volunteer has concluded that although
the precise cause of death is "likely to remain uncertain,"
it believes her death resulted from exposure to inhaled
hexamethonium. Committee members based their conclusion on
"the timing between hexamethonium inhalation and the
development of pulmonary symptoms" and other factors.
The committee report, submitted July 16 to
the federal Office of Human Research Protection, said the
autopsy on the volunteer, Ellen Roche, showed widespread
lung damage but "provided no specific etiologic diagnosis."
Nevertheless, the committee report said, "the death was as
the result of participation in the hexamethonium phase of
Hopkins' response to OHRP suspension of
In what Johns Hopkins believes to be an unwarranted,
unnecessary, paralyzing and precipitous action, the Office
of Human Research Protection today suspended all federally
supported medical research projects involving human subjects
at almost all of our institutions. We strongly believe that
this action was taken in utter disregard of patients' health
and potentially of life. Even a temporary interruption in
therapeutic clinical trials, such as those involving cancer
patients, could be devastating. In addition, the OHRP letter
forbids us from enrolling new, sick patients in these
President visits Hopkins to deliver
On Friday, July 13, President George W. Bush visited the
JHMI campus to give an address promoting his Medicare reform
plans. Bush had unveiled his new drug discount plan for
Medicare beneficiaries the previous day at a ceremony in the
White House's Rose Garden.
Bush, making his first public appearance
in Baltimore since taking office, was accompanied by Tommy
Thompson, secretary of health and human services.
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