Vaccine Safety Questions Rise.(hepatitis B vaccine)

ON MAY 18, 1999, REPRESENTATIVE John Mica (R-FL) chaired a congressional hearing on the hepatitis B vaccine, a hearing precipitated by parents' phone calls. "Hepatitis B Vaccine: Helping or Hurting Public Policy" was heard by the subcommittee on Criminal Justice, Drug Policy, and Human Resources. Controversy erupted as scientists, doctors, hepatitis B vaccine-injured children, and adults urged the US House subcommittee to block forced vaccination policies.

Government health officials, members of the FDA and Centers for Disease Control (CDC), and others defended the safety and necessity of the hepatitis B vaccine.

During the five-hour, packed hearing, Chairman Mica asked, "Is it possible that the preventative measure for this disease is riskier than the disease itself?" He chided government officials for their evasiveness on the adverse reaction statistics and for discounting reactions as "coincidental, by chance and association in time."

Both hearing and press conference witnesses shared grim stories following hepatitis B vaccination: autism, multiple sclerosis, paralysis, arthritis, mental confusion, exhaustion, and death.

Milwaukee immunologist Burton Waisbren, MD, called universal hepatitis B vaccination an experiment and cited numerous peer-reviewed articles about autoimmune diseases after hepatitis B vaccination.

Bonnie Dunbar, PhD, a cellular biologist at Baylor College of Medicine, stated that many of the adverse reactions to the vaccine are similar to those of the virus. Barthelow Classen, MD, claimed a 60 percent increase in diabetes in New Zealand following massive hepatitis B vaccinations. In this case, diabetes did not occur for three to four years.

Michael Belkin, New York, whose two-month-old Rose died shortly after a hepatitis B vaccination, demanded safety-proof vaccines for newborns. Belkin, a Wall Street financial advisor, challenged the government's inflated disease statistics. He emphasized, "They are passing off estimated, hypothetical numbers as actual cases. This is statistical fraud. In the financial world such misrepresentations would lead to criminal charges." Belkin reported that the US government database shows 1,080 hepatitis B vaccine adverse reaction reports with 47 reported deaths in infants under one year of age. These statistics outnumber the 54 actual hepatitis cases 20 to one for the same period.

Congressman Mica kept open the comment period for 30 days to allow for more written testimony. He promised additional subcommittee attention to vaccines, especially the National Vaccine Injury Compensation Program. He said that the hearing "raised more questions than it did answers."

Less than two months after the congressional hearing, some responses are forthcoming. The Association of American Physicians and Surgeons (AAPS) is calling for an immediate moratorium on mandatory hepatitis B vaccines for schoolchildren pending further research about dangerous side effects.

"Children younger than 14 are three times more likely to die or suffer adverse reactions after receiving hepatitis B vaccines than to catch the disease," states Jane M. Orient, MD, executive director of AAPS.

"It is one thing to bar a student from school if he is carrying an infectious disease ... but to require a questionable medical treatment as a condition of attendance crosses over the line to practicing medicine."

At the same time, a joint statement by the US Public Health Service (USPHS) and the American Academy of Pediatrics (AAP) calls for a roll back of the universal recommendation that all newborn infants receive hepatitis B vaccine at birth and for a delay in vaccination of premature or underweight infants.

The statement also calls for the elimination of mercury content in hepatitis B vaccine and other childhood vaccines. The cumulative effect of mercury can cause brain damage. Thimerosol, a mercury compound, is used as a preservative in hepatitis B, diphtheria, pertussis and accelular pertussis, tetanus, and HiB vaccines.

Thimerosol has been used as an additive to biologics and vaccines since the 1930s because it is effective in killing bacteria and in preventing bacterial contamination.

The Food and Drug Administration (FDA) Modernization Act of 1997 called for the FDA to review and assess the risk of all mercury-containing food and drugs. The FDA asked US vaccine manufacturers to provide more detailed information about the thimerosol content of their preparations.

In June of 1999, the government notified vaccine experts that if infants younger than six months receive a number of thimerosol-containing vaccines at the same doctor's appointment, the thimerosal levels could add up enough that small babies might temporarily hit the EPA's precautionary limit on mercury exposure.

On July 15, 1999, the Centers for Disease Control and Prevention (CDC) postponed the use of the rotavirus vaccine for infants. An estimated 1.5 million doses of rotavirus vaccine have been administered to infants since it was licensed on August 31, 1998. As of July 7, 1999, the Vaccine Adverse Event Reporting System (VAERS) has received 15 reports of bowel obstruction (intussusception). Symptoms include persistent vomiting, bloody stools, black stools, abdominal bleeding, or severe colic pain.

Some critics of the vaccine point out that rotavirus is highly treatable with rehydration therapy in the US and does not cause widespread death among US children. The CDC estimates that 20 to 40 deaths are associated with rotavirus infection every year in the US.

RotaShield, an oral vaccine, is a genetically engineered human-monkey hybrid strain of rotavirus. The vaccine's efficacy rate ranges from 48 to 91 percent. It was recommended for universal use by the CDC's Advisory Committee on Immunization Practices (ACIP) six months before the vaccine was licensed by the FDA on August 31, 1998. The three-dose series of RotaShield is priced at $240.