FDA Faults Johns Hopkins Researchers
July 5, 2001
According to the Food and Drug Administration (FDA), a young woman who died in a Johns Hopkins University clinical trial was not informed of the experimental nature of the medication she was given. In addition, FDA investigators cited the study's organizers for failing to report a previous adverse reaction to the medication. The study was conducted to determine how the human body reacts to inhaled irritants.
The otherwise healthy victim became ill shortly after participating in the trial. Hospital officials said that the woman initially suffered from flu-like symptoms such as dry cough, difficulty breathing, muscle aches, and high fever. Her condition continued to deteriorate and her blood oxygen level fell precariously low.
Study participants were given methacholine and hexamethonium, two substances known to restrict airways. Researchers then examined how the participants reacted to the chemical agents. The FDA considers hexamethonium an "investigational drug" as it has not been proven effective. As such, any clinical trial in which hexamethonium is used must be approved by the agency. FDA officials claim that Hopkins researchers never sought the agency's approval.
The FDA also faulted Hopkins researchers for failing to report a similar, though less severe, adverse reaction that occurred several days before the woman's death. In addition, the agency found that researchers did not follow the study protocol, which was approved by an institutional review board in order to protect the health of the participants. The protocol called for the participants to inhale hexamethonium, however, at least two participants received the drug in other forms.
-- Article Courtesy of InjuryBoard.com
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