REPEAT/FDA Invites PICK President Susan E. Sheridan to Testify at Upcoming Advisory Committee Meeting on Hyperbilirubinemia.

News Editors/Health/Medical Writers

REPEATING...

WASHINGTON--(BUSINESS WIRE)--June 5, 2003

The U.S. Food and Drug Administration (FDA) has invited Susan E. Sheridan, President of Parents of Infants and Children with Kernicterus (PICK) to testify at an Advisory Committee meeting on the current epidemiology and therapeutic interventions relevant to hyperbilirubinemia in the term and near-term newborn on Wednesday, June 11, 2003.

Hyperbilirubinemia can cause kernicterus, a preventable brain injury that involves permanent brain damage and other complications that may include cerebral palsy, auditory neuropathy, gaze abnormalities, and dental enamel hypoplasia. Early detection and treatment of hyperbilirubinemia is critical for prevention of kernicterus.

Mrs. Sheridan, mother of an 8-year old with kernicterus, said "The Federal Government has intervened to protect our children from household, pharmaceutical and other toxins. Yet it has failed to protect infants from a naturally occurring neurotoxin, bilirubin, which causes the jaundice that afflicts 60% of all the babies born in this country."

All babies produce bilirubin and are at some risk for bilirubin toxicity if not well monitored and managed. Some babies are more susceptible to developing jaundice due to a variety of factors including ethnicity, genetic disorders, and perinatal circumstances. Babies of East Asian and Mediterranean descent have an increased vulnerability to jaundice, as do families with a history of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. Babies that have signs of jaundice in the first 24 hours of life, bruising from delivery, undetected hemolysis or blood incompatibility, infection, and non-optimal sucking may also be at increased risk for severe jaundice.

Kernicterus was common in the United States in the 1950's. At that time, it was the second leading cause of cerebral palsy. Kernicterus was believed to have been eliminated by the 1970's, although it continued to occur outside the U.S., principally in underdeveloped countries. Since the 1990's, with the rise in managed care and changes in guidelines for treating neonatal jaundice, kernicterus has reemerged in the U.S.

Many leading public health and patient safety experts will be testifying at the FDA meeting, including:

Marshalyn Yeargin-Allsop, M.D., Medical Epidemiologist, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention 

Vinod K. Bhutani, M.D., Clinical Professor of Pediatrics, University of Pennsylvania School of Medicine, Pennsylvania Hospital

Martin J. Hatlie, J.D., President, Partnership for Patient Safety

The CDC's National Center on Birth Defects and Developmental Disabilities has been particularly vigilant in its efforts to prevent kernicterus. Earlier this year, the NCBDDD awarded funds for two cooperative agreements for research and prevention of kernicterus. The recipients were Pennsylvania Hospital in collaboration with PICK and Saint Peter's University Hospital, UMDNJ-Robert Wood Johnson Medical School.

The FDA meeting will be held on June 11, 2003 from 8:30 a.m. to 5 p.m. and is open to the public:

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PICK (www.pickonline.org) is an educational, advocacy and support group founded in 2000 by a group of mothers of children with severe cerebral palsy resulting from kernicterus. The mothers, realizing that their children's injuries were not as rare as the medical and public health communities estimated, mobilized to create awareness about kernicterus and strategies for eradicating this preventable brain injury.