Clinical trials: chasing recruits

Ann Silversides

doi:10.1503/cmaj.090063

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Factual error
Michel Bilodeau

Posted on: 25 February 2009

Posted on: (25 February 2009)
Page navigation anchor for Factual error
Factual error
Michel Bilodeau
Ann Silversides writing about the 2002 accidental overdose death of Ryan Lucio at our institution (CMAJ, February 17th) states "Some tragedies have become public, thanks to the US Food and Drug Administration (FDA) or a measure of investigative reporting. ...... His (Ryan's) death became public because of an FDA inspection, the results of which were posted on the agency's website."
This statement is not based on...
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Ann Silversides writing about the 2002 accidental overdose death of Ryan Lucio at our institution (CMAJ, February 17th) states "Some tragedies have become public, thanks to the US Food and Drug Administration (FDA) or a measure of investigative reporting. ...... His (Ryan's) death became public because of an FDA inspection, the results of which were posted on the agency's website."
This statement is not based on facts.
While the FDA inspection took place in early 2003, our error was reported to Canadian and American federal agencies on the day it was detected and to the public the day after (Child dies at CHEO after accidental overdose: Hospital miscalculated dosage of experimental drug; Siri Agrell. The Ottawa Citizen, Oct 8, 2002).
Ryan's death was a devastation for the Lucio family. It rocked our Hospital as well, leading not only to an extensive systematic review and a revamping of our procedures in clinical trials but considerable anguish and soul searching. To compound this tragedy by suggesting there was a cover up is simply incorrect and questionable reportage.
The Children’s Hospital of Eastern Ontario
Michel Bilodeau President and CEO Michael Leonard Chief of the Medical Staff
Conflict of Interest:
None declared
Editor's Note:
CMAJ regrets this error and apologizes for any inconvenience that it may have caused.
Barbara Sibbald
Deputy Editor, News and Humanities
CMAJ
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Competing Interests: None declared.