Introduction Government's Expanding Role Is Your Child Worth More Than $250,000? New Mandatory Vaccine for Hepatitis B Conclusion Introduction Since the late nineteenth century, public health officials have recommended and enforced vaccines for a small number of highly infectious and communicable diseases. Today, however, there are more than 200 new vaccines in the research pipeline, including one for HIV. Federal health officials (U.S. Centers for Disease Control) commonly recommend new vaccines as soon as they receive FDA approval and are placed on the market. State health departments then routinely add new vaccines to the list of compulsory vaccines required for school entry. In most states, this occurs through the regulatory process without a vote by the legislature, although most states have religious, philosophical, and medical exemptions. Currently, the majority of American children are given 33 doses of 10 different vaccines by the time they reach age five. But before this trend goes any farther, lawmakers and parents should question the long-term effects of these vaccines on children's health and consider the proper role of government in this area. Government's Expanding Role Why the trend toward new mandatory vaccines? For one thing, Congress placed price controls on routine childhood vaccines in 1993. But the price controls did not apply to new vaccines. Thus, manufacturers have had an incentive to develop and enforce new vaccines for children, since the new products are exempt from price controls. Conventional wisdom maintains that children are healthier and are living longer because of mandatory vaccine policies. However, a book edited by Philip R. Lee, former Assistant Secretary of Health and Human Services, explains that during the early part of the nineteenth century, mortality for the childhood diseases whooping cough, measles, and scarlet fever had fallen to a low level before effective immunization became available. The figure below shows that the rate of death attributed to measles in Massachusetts between 1860 and 1970 had dropped long before the measles vaccine was introduced in 1963, according to government data. Decreased mortality in the nineteenth century is primarily attributed to improved basic hygienic measures, including purification of water, efficient sewage disposal, and improved food hygiene.   Massachusetts Deaths Caused by Measles: 1860 to 1970 Figure 1 Vaccine manufacturers, health-care providers, and public health officials are correct to point out that since the introduction of the measles vaccine, the rate of disease has declined. But they neglect to mention that the number of deaths caused by measles was declining long before the vaccine was mandated. Given this lack of historical information, parents and state legislators rarely question whether or not a new vaccine should be mandatory. Instead, they routinely endorse federal recommendations based on the scientific evidence that shows a vaccine is associated with decreased childhood mortality. It is not until a child suffers a serious side-effect or death before most parents examine historical data and begin questioning government vaccine policies. Is Your Child Worth More Than $250,000? Although states have police power to mandate new vaccines, the federal government is in charge of compensating children and their families for any serious vaccine-related injuries or death. Scientists agree that all medical products, including vaccines, have risks. For many years, vaccine risks went unnoticed and unreported. However, during the 1980s, a national television program publicized the serious side-effects caused by the mandatory DPT vaccine (diphtheria, pertussis, and tetanus). Consequently, a national grassroots movement was established and parents began questioning the benefits and risks of vaccines. Parents of injured children also began suing vaccine manufacturers. Not surprisingly, vaccine manufacturers began threatening to stop producing vaccines because their liability insurance premiums skyrocketed. In an attempt to improve vaccine safety and minimize manufacturers' liability, Congress enacted the 'National Childhood Vaccine Injury Act of 1986' (PL 99-660). This law created a Vaccine Injury Compensation Program (VICP) which is administered jointly by the U.S. Federal Claims Court, the Department of Health and Human Services (HHS), and the Department of Justice (DOJ). The compensation program serves as a no-fault alternative to the tort system for resolving claims resulting from adverse reactions to mandatory childhood vaccines, whether administered in the private or public sector. As a result, all parents must first apply to the federal government for compensation if they feel their child has suffered from a mandatory vaccine. If a claim for compensation is rejected by the federal government, or if parents believe the compensation offered is too inadequate to provide for their child's lifelong care, then parents can then file a vaccine injury lawsuit against the vaccine manufacturer. The federal government caps the amount it pays for vaccine damages. The maximum amount a parent may receive for a vaccine-related death of a child is $250,000 plus expenses. By 1997, the federal government had awarded nearly $1 billion dollars to more than 1,000 families whose children suffered catastrophic reactions to mandated vaccines. Yet, according to the National Vaccine Information Center (NVIC), it is extremely difficult to get an award from the federal compensation program and few parents have the emotional energy to pursue a lawsuit after battling the federal legal establishment. The NVIC also notes that: "Since the National Childhood Vaccine Injury Act was passed in 1986, HHS officials and Justice Department lawyers have systematically gutted the law by passing federal regulations that narrow the criteria that special masters employed by the U.S. Claims Court may use to make awards to vaccine-injured children." New Mandatory Vaccine for Hepatitis B In addition to routine childhood vaccines, federal health officials have recommended that all infants and children ages 11-12 get vaccinated for Hepatitis B. But unlike other communicable diseases that are easily transmitted via air and casual contact, Hepatitis B is transmitted by direct contact with blood and body fluids. Those at risk for contracting the disease include intravenous drug users, sexually active individuals, blood transfusion recipients, health care workers, and babies born to high-risk mothers. Why then, if those are the groups most at risk, is the government pushing for all children to be vaccinated against Hepatitis B? Why are parents' children being kicked out of public school for refusing the Hepatitis B vaccine? Why are newborns of healthy mothers being injected before leaving the hospital; and why don't hospitals screen expectant mothers to find out if they are carrying the Hepatitis B virus, instead of vaccinating all newborns? Currently, only 15 states have laws requiring screening of pregnant women for Hepatitis B infection. As recently reported in a Regulation article, the government's public health officials could not effectively vaccinate intravenous drug users and prostitutes. Therefore they are forcing all children -- even those not at risk -- to be vaccinated against Hepatitis B. The CDC's web site explains: "While most HBV [Hepatitis B virus] infections occur among older adolescents and young adults, vaccination of persons in high-risk groups has generally not been a successful public health strategy." In other words, the government could not force adults in the high-risk behavior groups to accept the Hepatitis B vaccine, so they are going after newborns and young children - the groups least likely to contract or transmit the disease. Currently, Hepatitis B vaccine is required for children in 35 states, with medical exemptions in all states, religious exemptions in all but two states, and philosophical exemptions in 16 states. Public health advocates argue the benefits outweigh the risks, so parents should vaccinate their children. However, civil libertarians and those in favor of a free market raise an important question. Who should be making this decision in the first place? Why should Johnny be vaccinated against his will if he is not at risk for contracting or transmitting Hepatitis B? And why should Johnny's parents be forced (by state law) to vaccinate their child for Hepatitis B, if Johnny poses no threat to himself or to other students? Some parents have refused to have their children vaccinated for fear of unknown long-term side effects. The CDC's web site assures Americans that the Hepatitis B vaccine has been shown to be very safe when given to infants, children, and adults. Yet, the Physicians Desk Reference (PDR) tells another story. The PDR lists a host of serious side effects that occur with less than one percent of injections. This number sounds small, but when one considers there are more than 70 million American children, that means nearly 700 thousand children could suffer serious adverse reactions. That is more than the approximately 30 thousand infants and children the CDC claims were infected each year before routine Hepatitis B immunization began. Individuals worldwide are challenging the Hepatitis B vaccine policy. In March 1998, an Illinois student testified before a Springfield Board of Health public hearing on vaccinations. He explained he was kicked out of college during the middle of the semester because he refused the vaccine. In France, the Ministry of Health suspended Hepatitis B vaccinations in French schools because of the public's concern about long-term side effects. Meanwhile, concerned parents in Canada recently went to court asking the government to stop Hepatitis B vaccinations for up to 18 thousand fourth-grade students across Manitoba. Despite public resistance to the Hepatitis B vaccine, the World Health Organization (WHO) strongly encourages all countries already using the Hepatitis B vaccine as a routine vaccine to continue its usage. WHO also urges countries not yet using the vaccine to begin as soon as possible. Conclusion Americans in general and legislators in particular need to remember that the role of our government is to protect individual rights; not to run individual lives. Our country was founded on the principle of individual liberty, not state control. Times change, technologies change, and we see new health care advances every day. But one thing remains the same: Americans have an inherent desire for freedom of choice. The United States should set the world standard for liberty by giving parents the freedom to decide whether or not to vaccinate their children for Hepatitis B. If parents are not even allowed to reject questionable vaccines for preventable diseases, such as Hepatitis B, then what will be forced upon their children in the future? Where do we draw the line for vaccinating children? Government certainly has a legitimate role in making sure all parents understand the risks and benefits of vaccines. But in the end, parents should be the ones making important health care decisions for their children.   Note: This information is not intended as medical advice. Consult a physician for medical advice. By Sue Blevins. This article was originally published as a book chapter in the Legislator's Guide to Children's Issues: 1999, published by the Pacific Research Institute in San Francisco, CA.