Spring 1999 Volume 4, Number 1		Congress holds first-ever hearing on hepatitis B vaccine safety (Washington) The controversy over hepatitis B vaccine safety showed no signs of letup in May as a congressional subcommittee held the first-ever hearing on the subject on Capitol Hill. The Subcommittee on Criminal Justice, Drug Policy and Human Resources, House Committee on Government Reform, organized the hearing after receiving reports from vaccination protest groups about illnesses allegedly caused by the vaccine. The chairman of the subcommittee, Rep. John Mica (R-FL), asked "Is it possible that the preventive measure to the disease is riskier than the disease itself? That's the question we must ask ourselves." The answer to his question was a clear "yes" from a panel of witnesses who told stories of injuries they attributed to the vaccine, including seizures, paralysis, fatigue, dizziness, joint pain, sudden infant death, and others. Some of the same witnesses had appeared on the January broadcast of ABC-TV's 20/20 program, which questioned the safety of the vaccine and the wisdom of the national hepatitis B vaccination strategy (for a detailed review of the controversy, see the Hepatitis Control Report, Winter 1998-99 issue). Michael Belkin, a financial analyst from New York, again told the story of his infant daughter's death a few hours after receiving hepatitis B vaccine. Belkin believes that her death was a vaccine complication. Dr. Burton A. Waisbren, a physician from Milwaukee, told the Subcommittee that he believes demyelinating diseases such as multiple sclerosis are caused by the vaccine. Waisbren, a familiar figure in the vaccination protest movement, has made similar arguments against both the serum-derived and recombinant hepatitis B vaccines since the early 1980s. Witnesses against the federal hepatitis B vaccination strategy showed outrage that the vaccine was required for school entry in most U.S. states. Not only is the vaccine unsafe, they said, but it lacks true efficacy in reducing the transmission of hepatitis B. Immunization and child health advocacy groups saw the hearing as the latest in a series of attacks on the nation's hepatitis B control effort, which aims to eliminate hepatitis B transmission in U.S. children by the year 2010. Pro-vaccination groups had learned of the hearing almost by accident just days before it occurred. They quickly mobilized and wrangled invitations to testify. Dr. Harold S. Margolis, Chief of CDC's Hepatitis Branch, again emphasized the risk that hepatitis B disease presents to infants and young children, pointing out that the virus infects at least 25,000 children each year, many of whom go on to chronic infection and its sequelae. Margolis argued that the vaccine is safe and repeated the conclusion of CDC, FDA, and several scientific bodies that there is no evidence linking the vaccine to sudden death in infants, to multiple sclerosis, or to any other serious adverse event. Dr. Susan S. Ellenberg, an official at FDA, said, "At present, we have well documented benefits and little in the way of verified serious risks." Dr. Samuel L. Katz, Professor Emeritus at the Duke University Department of Pediatrics and former Chairman of the Advisory Committee on Immunization Practices (ACIP), spoke on behalf of the American Academy of Pediatrics and infectious disease professional societies. He said, I wish we could find the true causes for serious, complicated, and often vexing medical conditions such as multiple sclerosis and autism. But the fact is, there are no scientifically sound studies that demonstrate current immunization recommendations are a cause of autism, diabetes, asthma, inflammatory bowel disease, SIDS, multiple sclerosis, or any number of acute or chronic diseases. Vaccination protest groups were not satisfied. Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, a leading vaccination protest group, said, "The lack of informed consent protections in mass vaccination programs is leading to fear and mistrust of the whole vaccination system. What we hear parents saying is: show us the science and give us a choice." She called for "an investigation into federal health agency licensing and policymaking standards applied to the recombinant hepatitis B vaccine."