Expecting a seizure? Plan ahead if you don’t want to be in a trial

From the USA Today (Drug study on kids won’t require consent):

Children in 11 major cities who suffer life-threatening seizures will, for the first time, be enrolled in a drug study without their parents’ consent, the National Institutes of Health announced Wednesday.

The trial, which will test how two well-established drugs work in children who have seizures that last for more than 30 minutes, is being conducted under a controversial federal rule that allows researchers to test human subjects in an emergency without consent…

“Medication must be administered within five minutes of arrival in the emergency department,” says James Chamberlain, emergency medicine chief at Children’s National Medical Center in Washington, D.C., one of the principal investigators leading the study. “We don’t have time to talk to the parents about the study during the seizure episode.”

FDA requires public meetings in the cities where the trial is being conducted and lets parents opt out if they don’t want their kids included. There have been some objections by ethicists, and an expectation that some parents will be angry. On the other hand, parents are dreaming if they think they can control what happens when their kid arrives in the ER in the midst of a seizure. (Who knows how often this combo is already being used, for example.) Let’s just hope the combination works.

The trial sites are at major children’s hospitals in Ann Arbor, Baltimore, Boston, Buffalo, Davis (CA), Detroit, Milwaukee,  Philadelphia, Rochester (NY), Salt Lake City, and Washington.

May 24, 2007

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