June 20,2001 BALTIMORE (AP) - Two federal agencies have warned hundreds of research institutes nationwide about the drug tested on a volunteer who died in a Johns Hopkins asthma study.
The National Heart, Lung and Blood Institute, which is part of the National Institutes of Health, sent e-mail letters on Monday to nearly 200 grantees and also sent a hard copy to them on Tuesday.
"The word has been getting out to other scientists around the country," NHLBI spokeswoman Diane Striar said.
On Thursday, the Office for Human Research Protections, part of the U.S. Department of Health and Human Services, began investigating the June 2 death of Ellen Roche, a Johns Hopkins Asthma and Allergy Center technician. Johns Hopkins officials did not make her death public until last week and informed the OHRP of the death in a June 6 letter. Autopsy results are pending.
The study volunteer, who had been healthy before participating, died one month after inhaling hexamethonium, a blood pressure medication known to restrict airways.
HHS spokesman Bill Hall said that the federal agency sent an e-mail to about 100 research institutions on Thursday, asking them "to sort of canvass their portfolio of research." The agency also posted a short warning on their Web site.
"(Institutional Review Boards) should reassess protocols involving inhalation of hexamethonium and, if necessary, consider temporarily suspending the research in light of this event."
The Bayview Institutional Review Board, which approved the drug for Hopkins, discussed the death at a June 4 meeting and planned to review the study.
Hopkins spokeswoman Joanne Rodgers has refused to comment, citing a request by Roche's family.
A Roche family spokesman and attorney, Craig Schoenfeld, said Tuesday night that "the family has no immediate comment."
Dr. Solbert Permutt, a pulmonary specialist, was the principal investigator in a series of federally funded experiments at the Johns Hopkins Asthma and Allergy Center.
He sent a letter to more than 100 asthma specialists on Friday, alerting them to Roche's death and advising them to reconsider using hexamethonium on test subjects.
Study volunteers were warned that they could experience symptoms of a mild asthma attack and received up to $365 for their participation.
Volunteers were also told that hexamethonium could lower blood pressure and make them feel dizzy.
Copyright 2001 The Associated Press. All rights reserved.