British Drug Trial Leaves Two in Critical Condition
Two men who volunteered in a clinical drug trial suffered severe reactions and are in intensive care in a British Hospital, according to a
"There are several possibilities as to what might have gone wrong," said MHRA Chief Executive Officer Kent Woods to BBC radio. "We've had inspectors on site since yesterday trying to clarify what exactly the event was that caused this disaster. Has there been some manufacturing problem? Has there been some issue of contamination? Has there been a dosing error or is this indeed some completely unanticipated side effect of the drug in humans, which is specific to humans?"
Ley commented that conducting clinical trials simultaneously in different parts of the world was now quite common, and noted that "tens of thousands of people, if not more" participated in clinical trials in Britain annually.
Parexel described the incident as "unfortunate and unusual," according to Reuters, and assumed the volunteers' reactions were adverse reaction to the drug. The head of Parexel International Clinical Pharmacology, Professor Herman Scholtz, said, "Such an adverse drug reaction occurs extremely rarely," according to Reuters
As soon as the men became ill, the MHRA stopped the trial and notified other European regulatory organizations about the event.
Source: British drug trial goes wrong, two critically ill, Reuters Health, March 15, 2006.
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