Safety of Controversial Hepatitis B Vaccine at Center of Debate

By JOHN HANCHETTE, Gannett News Service

WASHINGTON - A House oversight subcommittee on federal health policy Tuesday called into question the safety of the increasingly controversial hepatitis B vaccine. "Is it possible the preventative measure for this disease is riskier than the disease itself?" asked Rep. John Mica, R-Fla., chairman of the House Subcommittee on Drug Policy and Human Resources.

Mica presided at a packed five-hour hearing that featured a parade of defensive federal health officials, researchers and doctors pro and con on the inoculation, debilitated health workers who blame the shots for their illness, and aggrieved parents who claim the "hep B" vaccine killed or severely injured their children.

Hepatitis B is a serious disease that attacks the liver and can remain silent without symptoms for years. But high-risk populations generally are defined by the federal health structure as those who engage in unprotected sex with infected partners, drug addicts who use unsterile needles, police and medical emergency workers subjected daily to body fluids, and health employees who handle blood.

Mica opened the hearing noting that the most recent official federal figures show 10,600 new cases in 1996, but only 279 of those below the age of 14. Mica cited a recent New Hampshire study he "found shocking" that showed serious reactions to the vaccine including 11 deaths - "were 16 times greater" than incidents of the disease. Many of the witnesses supported hep B shots for teens or adults, but railed about official federal health policy that newborn babies with fragile immune systems get the first inoculation before leaving the hospital.

Several - like Manhattan statistician Michael Belkin, whose 5week-old daughter Lyla died in September just hours after her second hep B vaccination - claimed there was a lack of sufficient research on the vaccine's safety before the Centers for Disease Control recommended shots eight years ago.

According to witness Belkin, "If hepatitis B vaccine was recommended in 1991 without scientific proof that it was safe in a broad sample of babies less than 48 hours old, then the CDC has been experimenting on babies at birth like guinea pigs, and this committee should suspend that universal immunization policy. Milwaukee immunologist Burton A. Waisbren, a veteran clinical investigator opposed to the infant inoculations, told the panel "an injustice is being done to the children of this country."

Dr. Waisbren labeled infant hep B vaccination "an experiment sponsored by the CDC which is designed to determine if vaccination at birth of all babies in the United States will eventually decrease the frequency of cancer of the liver" sometimes caused by hepatitisB infection. "How," he asked, -can an experiment such as universal hepatitis B vaccination be adopted nationwide without congressional involvement or approval?"

Federal health officials insisted hep B shots are both safe and efficient. Dr. Harold S. Margolis, chief of the hepatitis branch for CDC's National Center for Infectious Diseases, said public health strategists have targeted babies because "many people do not know they are infected - that is the problem of early childhood detection." Thelma Thiel, chairman of Hepatitis Foundation International, described how individuals in high-risk groups are hard to inoculate: "We really have to get to them (babies and children) when we have access to them, in hospitals or in the schools."

Margolis, under Mica's questioning, revealed that 1997 figures, for the last year CDC has available, show 95 hep B cases reported nationally for children under age 2. When Mica pressed the FDA's chief of biostatistics, Susan Ellenberg, for comparative fatal reactions in 1997 under that agency's much-criticized reporting system, she replied 43 - but insisted they were "coincidental" or "by chance" and could not be linked scientifically to the hep B or any other shot.

Margolis, Ellenberg, and other federal scientists claimed the number of reactions is relatively small. Clifford Shoemaker, a Virginia lawyer who handles vaccine reaction cases, said he has filed about 30 cases involving hep B reactions in the last couple of years before the National Vaccine Injury Compensation Program - an agency set up to recompense parents of children killed or injured by mandated vaccines. He has another 40 ready to file. "We're seeing the tip of the iceberg," he told Gannett News service.

Baylor College of Medicine molecular biologist Bonnie Dunbar, testified she has studied "hundreds of people who were perfectly healthy but are now debilitated for life" after getting the hep B shot. Dunbar said she believes the shot can cause severe reactions in certain immune systems, and warned the public reaction to all vaccines "will be doomed in the public's eye" unless the government does something about hep B inoculations.

Barbara Fisher, president of the National Vaccine Information Center, a Vienna, Va.-based parental advocacy group, testified that package insert sheets supposedly warning parents of reactions are "woefully inadequate" and don't list the more serious reactions. Mica promised further subcommittee attention to the issue. He said the hearing "raised more questions than it did answers."

Published in The Orlando Sentinel on May 19, 1999.

Tamara Lytle, Washington Bureau

WASHINGTON -- Does the hepatitis B vaccine cause severe side effects in some people?

Witnesses who testified before Congress on Tuesday offered themselves and their loved ones as evidence that it does. Experts, however, said they have no proof. And those with hepatitis B said the risks are worth taking to avoid spreading the sometimes fatal disease. About 20 million Americans have been given the vaccine, which medical experts said Tuesday has slowed the spread of hepatitis.

But some witnesses said their illnesses were caused by the vaccine itself. Federal regulators and drug companies have not done enough, they said, to study why some people have adverse reactions to the vaccine. Until more is known, they argued, states such as Florida should not require schoolchildren to be immunized. Rep. John Mica, R-Winter Park, called the witnesses before his Subcommittee on Criminal Justice, Drug Policy and Human Resources. Is the vaccine helping or hurting public health?, he asked.

Officials from the Centers for Disease Control and Prevention and the Food and Drug Administration, which approved the vaccine, said there is no proof it causes the immune diseases and other problems some patients complain about. "The disease is what puts a child at risk -- not the immunization," said Joel Alpert, head of the American Academy of Pediatrics.

Several panelists who suffer from hepatitis B said they hope others get the shots so they can avoid the disease, which attacks the liver. Hepatitis B is 100 times more contagious than the virus that causes AIDS, said Rep. Joe Moakley, D-Mass., who himself has hepatitis. Moakley, who may have contracted the disease on a congressional fact-finding trip to China, said the benefits of immunizations far outweigh the risks that other witnesses outlined.

"As sad as these stories are, they should not determine public health [policy] in this country,' Moakley said. Barbara Haun of Cincinnati, who has worked with deaf pupils, urged parents to get their children immunized because hepatitis can be spread many ways -- not just through needles and sex. "I work with your children," she said. "I didn't know I had it for 20 years." But Mica is worried about evidence that some patients have been hurt by the vaccine. "it left me with as many questions as answers," he said after the hearing.

Mica said he will look into whether parents should get more warnings about possible side effects and have the choice to refuse the vaccine for their children. He also will check into whether adequate research is being done on the vaccine's side effects. Several parents called for an end to the mandatory vaccines. Michael Belkin, a financial adviser from New York City, brought along two boxes of complaints about adverse vaccine reactions -- 17,000 of them from people who had gotten the hepatitis B shot. Belkin said his newborn daughter died a few hours after her vaccine, and his research showed a connection.

Judy Converse, a Massachusetts mother with a master's degree in public health, said her son, Benjamin, was normal at birth but began having seizures four days later after his shot. Congress should make states drop the mandate that newborns be immunized until more research is done, she said. Marilyn Kirschner of Coral Springs said her daughter was healthy just days before entering high school when she got her vaccine. Now Lindsay, 16, takes 10 medications a day to reduce dizziness enough so she can stand up. "My daughter shouldn't have to suffer like this because government officials and drug companies don't do their jobs," Kirschner said. Betty Fluck of Kokomo, Ind., who uses leg braces and arm supports, said she was healthy until she took the vaccine as a requirement for a nursing job.