June 18, 1997
New trauma drug may save patients from shock-related death
A promising new drug called Hu23F2G that may save the lives of severely injured patients is now being tested by University of Washington (UW) physicians based at Harborview Medical Center. Hu23F2G works by temporarily stopping the action of white blood cells, which frequently overreact to trauma by attacking the body’s own organs, causing damage to the heart, lungs, kidneys, liver and other organs.
“Injury is one of the leading causes of death in children and adults,” explains Dr. Nicholas Vedder, UW associate professor of surgery, and principal investigator of the Hu23F2G study. “In cases of severe blood loss and shock after major injury, there’s about a 50 percent chance of dying with standard treatment. To date, we have been encouraged with the outcome in the people we have treated with Hu23F2G.”
Because Hu23F2G acts on white blood cells, a possible side effect is an increased risk of infection. Antibiotics may be given to patients to minimize this potential risk. “In the patients treated thus far, the risk of infection does not appear to be significantly increased,” Vedder says.
It is believed that to be effective, the drug must be administered shortly after injury. Most of the severely injured patients admitted to the medical center are unconscious, and their family members may not be immediately available, making it difficult to obtain informed consent for using the drug. The U.S. Food and Drug Administration (FDA) allows waiver of informed consent requirements in emergency situations when the patient is at high risk of dying and consent is not obtainable from either the patient or family members. An independent UW group has carefully reviewed and approved the Hu23F2G study with waiver of informed consent after every attempt has been made to reach a family member within the required period of time.
A recent survey of over 500 King County residents found that a substantial majority approves of this research. The survey was conducted by Hebert Research, Inc. between April 11 and May 5, 1997.
Key findings include:
71 percent of respondents would want Hu23F2G administered without their written consent if they had a 25-50 percent chance of dying with standard treatment, knowing that it might improve their chance of survival but that there is a risk of infection.
76 percent believe that the exception to written consent is justified and in the best interests of patients and the community.
“After studying this drug in patients for over a year, it has become clear that it will be very difficult to study enough patients if we can only treat patients whose families arrive in time to give consent,” explains Vedder. “We believe a waiver of informed consent is justified in order to fully study the effects of Hu23F2G in the severely injured population, where there is currently no other treatment available to prevent organ damage.”
Harborview Medical Center and the University of Washington welcome public comment on the Hu23F2G study. Comments may be addressed to: Nicole Klotz, Hebert Research, 13629 N.E. Bel-Red Road, Bellevue, WA 98005, or call (425) 643-1337, ext. 123