From
Pediatric News

Hepatitis B Vaccine Grievances Aired

Miriam E. Tucker, Senior Writer

[Pediatric News 33(6):1, 6, 1999. © 1999 International Medical News Group.]

WASHINGTON -- The hepatitis B vaccine is under fire, and Congress is paying attention.

At a hearing of the House subcommittee on criminal justice, drug policy, and human resources, Rep. John L. Mica (R-Fla.) listened intently to testimony from "victims" of the hepatitis B vaccine and to individuals allied with the National Vaccine Information Center (NVIC), who demanded more state philosophical exemption laws allowing parents to opt out of having their children vaccinated against hepatitis B. (See related report, page 9.)

They also asked for expansion of the Vaccine Injury Compensation Program (VICP) to cover injuries they attribute to the hepatitis B vaccine and for better informed consent for parents prior to vaccination of their children. Several questioned the rationale for vaccinating newborns against a sexually transmitted disease.

The other side included federal officials who reiterated the public health rationale that universal immunization of infants is the only effective way to eliminate hepatitis B transmission. Among the witnesses who testified in support of the vaccine were representatives from the Centers for Disease Control and Prevention, the Food and Drug Administration, and the American Academy of Pediatrics, as well as persons with hepatitis B.

"The purpose of this hearing is not to scare parents away from vaccinating their children," subcommittee chair Mica said in his opening statement, but "I have some concerns about whether [VICP] is working the way Congress intended it."

The congressman has not sponsored any legislation as yet but is considering drafting a bill that might redirect use of the $1 billion currently in the VICP trust fund, a subcommittee staffer told PEDIATRIC NEWS.

The hearing followed by a few months a report on ABC's 20/20 focusing on NVIC's claims of adverse events, including multiple sclerosis, other autoimmune and neurologic problems, and infant deaths associated with the hepatitis B vaccine. The NVIC, formerly known as Dissatisfied Parents Together, was initially set up in opposition to the whole-cell pertussis vaccine. "It's DTP all over again," one observer noted at the hearing.

Witnesses included a 15-year-old girl who testified that her daily headaches, nausea, seizures, dizziness, fatigue, and other symptoms date back to receipt of three doses of the hepatitis B vaccine 2 years ago, a father who said his infant daughter died within 12 hours of receiving the vaccine, and a mother whose previously normal 2-year-old son had seizures after being vaccinated and is now severely developmentally delayed.

Barbara Loe Fisher, cofounder and president of NVIC, said her group wants an investigation into the federal licensing and policy-making standards applied to the recombinant hepatitis B vaccine. The group also wants congressional appropriations to fund nongovernment, nonindustry research to identify genetic and other risk factors for adverse hepatitis B vaccine reactions. They also advocate better informed consent protections in vaccine policies.

"The information sheet on hepatitis B, produced by the [CDC] in compliance with ... the National Childhood Vaccine Injury Act, does not come close to meeting the informed part of informed consent," Ms. Fisher said, noting that anaphylaxis is the only severe adverse reaction listed.

She also criticized the VICP, saying that three-quarters of filed claims are being dismissed. "We are extremely disappointed in how this program has been administered."

Vaccine supporters fought the accusations. Dr. Harold S. Margolis, chief of the CDC's hepatitis branch, said that 1.25 million Americans are chronically infected with hepatitis B, and 4,000-5,000 people die from it each year. While 59% are infected as adults, 18% are infected as newborns, 18% during childhood, and 6% during adolescence. Between 15% and 30% have no known risk factors.

Susan Ellenberg, Ph.D., director of the FDA's division of biostatistics and epidemiology, explained that the Vaccine Adverse Events Reporting System (VAERS), cited by the anti-hepatitis B vaccine contingent as evidence of the damage caused by the vaccine, cannot be used to determine causality.

Each year, the VAERS receives 11,000-12,000 reports of adverse events following vaccination. These come from physicians, patients, and manufacturers. Approximately 15% of the reports describe a "serious" event. These reports are of temporal associations, not of proved causality, Dr. Ellenberg stressed.

A thorough evaluation is always done when a pattern suggesting a potential problem arises in VAERS. In the first few years following the recommendation for universal infant hepatitis B immunization, no serious events likely to be attributable to the vaccine emerged, she testified.

Dr. Samuel L. Katz, representing the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics, addressed another accusation, that the federal vaccine policy development process is tainted because of conflicts of interest between members of the Advisory Committee on Immunization Practices of the CDC and vaccine manufacturers.

Dr. Katz, who chaired ACIP in 1991, the year the committee recommended that the hepatitis B vaccine be added to the routine infant immunization schedule, said there are no vaccine manufacturers or government officials on ACIP. Members with perceived conflicts must recuse themselves from voting on any question involving a vaccine made by a company with which they have a relationship, he said.