Trauma Drug Is A Lifesaver -- Fda Approval Sought For Emergency Use
Seattle Times Staff Reporter
A pleasant evening on Memorial Day weekend nearly turned fatal for Jennifer Vaughn and a friend, Melissa Russell.
In the afternoon they were two Arlington High School seniors on their way to meet friends. At 7 p.m. they were the victims of a car accident.
Russell was thrown from the car, breaking several bones.
Vaughn, who was driving, became the passenger in a helicopter bound for Harborview Medical Center's trauma unit. She suffered major internal and head injuries and her body would soon swell like a balloon - a common reaction for trauma victims.
Her chances of surviving were no better than 50-50.
Her desperate father, Jim Vaughn, signed a consent form allowing her to receive an experimental drug. It may have saved her life. Today, despite some scars, Vaughn said she has fully recovered.
Vaughn is one of about 20 people who have been treated with a new drug called Hu23F2G that physicians say could save many people who now die from traumatic injury.
"It is really the most potent anti-inflammatory that we know of," said Dr. Nicholas Vedder, a University of Washington associate professor of surgery and a principal investigator in the Hu23F2G study under way at Harborview.
But the intravenous drug has been difficult to test so far because of the unusual circumstances of trauma injury and the need for patient or family consent.
"I think (the drug) is promising but still investigational," said Dr. John Harlan, a UW professor of medicine. "There can always be unexpected surprises."
Within a few months, a UW board will review the Harborview testing and seek a waiver from the U.S. Food and Drug Administration to let doctors use Hu23F2G without families' permission in life-threatening situations.
According to doctors, the intravenous drug - called "the trauma vaccine" by some - protects the body from overactive white blood cells.
In trauma victims, who have suffered severe shock, the white blood cells often overreact and attack the body's own organs, damaging the heart, lungs, kidneys, liver and other organs.
The trauma drug acts as an antibody, preventing the white blood cells from attaching to blood-vessel-lining cells, where they can damage the blood vessels and impair organ function.
"It is like the Velcro that doesn't work anymore," said Vedder.
But there is a catch. For the drug to work effectively, it must be administered within four hours of injury, before trauma symptoms become too advanced. And consent is required to administer the medication.
That's where the problem lies, doctors say. Trauma patients often are unconscious and their families are difficult to contact in a short time.
As a result, Dr. Thomas St. John of Icos Corp., a Bothell-based pharmaceutical company which produces the drug, said that of about 300 trauma patients who have been eligible for it since clinical trials began 18 months ago, only about 20 have actually been treated.
"There are a bunch of treatments that are life-saving that are falling by the wayside because we can't get the consent," Vedder said.
To obtain a waiver of consent for administering the drug, the FDA requirements include evidence of community support, which the investigators are seeking.
Hebert Research, Inc., of Bellevue surveyed 501 King County residents and said 71 percent approved of administering the drug without a written consent under life-threatening situations, and 76 percent believed that the exception to written consent was justified.
If it is approved by the FDA, doctors eventually hope to use the drug to treat victims of strokes, heart attacks, vascular diseases and multiple sclerosis, as well as trauma.
-------------- Public comment --------------
Harborview Medical Center and the UW encourage public comments. They can be sent to Nicole Klotz, Hebert Research, 13629 N.E. Bel-Red Road, Bellevue, WA 98005. Or call 425-643-1337, Ext. 123.
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