Author: Jon Merz
Date: 05-24-07 10:02
Drug study on kids won't need consent; Seizure medications can be
given without telling parents USA TODAY May 24, 2007 Thursday
Copyright 2007 Gannett Company, Inc.
All Rights Reserved
USA TODAY
May 24, 2007 Thursday
FIRST EDITION
SECTION: LIFE; Pg. 5D
LENGTH: 428 words
HEADLINE: Drug study on kids won't need consent;
Seizure medications can be given without telling parents
BYLINE: Robert Davis
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.
The condition, status epilepticus, affects 50,000 to 60,000 children
and adults in the USA each year. Four to eight children per every
1,000 will experience status epilepticus by age 15.
"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."
The trial is expected to see how 240 children respond to two
anti-seizure drugs, diazepam and lorazepam. A computer will randomly
select which drug they are given. Lorazepam is often used "off
label," meaning it has not been approved by the Food and Drug
Administration for use in children.
The FDA requires that there be public meetings in the targeted cities
to inform residents about the study. Parents can opt in advance to
keep their children out of the study, a decision that will be
recorded in the emergency room where the study is being conducted.
"We consulted a wide range of ethicists and community leaders," says
Jill Baren, an emergency physician at Children's Hospital of
Philadelphia and the other principal investigator on the study.
Parents of children who have epilepsy are among the study advisers.
But Arthur Caplan, director of the Center for Bioethics at the
University of Pennsylvania in Philadelphia, says emergency physicians
and researchers may face "skepticism if not outright hostility" when
parents learn that "something was done without consent."
In addition to the Philadelphia and Washington hospitals, tests will
be conducted at these centers:
*Ann Arbor, Mich.: U. of Michigan Health System.
*Baltimore: U. of Maryland Hospital for Children.
*Boston: Children's Hospital.
*Buffalo: Women and Children's Hospital.
*Davis, Calif.: U. of California Medical Center.
*Detroit: Children's Hospital of Michigan.
*Milwaukee: Children's Hospital of Wisconsin.
*Rochester, N.Y.: U. of Rochester Medical Center.
*Salt Lake City: Primary Children's Hospital.
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