Shots in the Dark

Who should decide which vaccinations children receive?

Lyla Rose Belkin was an alert and lively baby at five weeks old. Her parents, Michael and Lorna Belkin, say she had never been sick until she received a mandatory hepatitis B shot on September 16, 1998. "That night she became agitated and feisty," her father recalls. "Then she fell asleep and never woke up." Doctors told the Belkins that Lyla must have died from Sudden Infant Death Syndrome, a catchall diagnosis.

For weeks, Michael and Lorna agonized over what could have caused their daughter's death. They wondered if the hepatitis B vaccination might have had something to do with it. Most doctors scoffed at their question and assured them the vaccine was safe. That's when they began investigating their baby's risk of contracting hepatitis B.

After much research, Michael Belkin says: "It's ridiculous to give this vaccine to a newborn. How is a baby possibly going to get hepatitis B?" Unlike diseases that are transmitted via air and casual contact, hepatitis B is transmitted by direct contact with blood and other body fluids. Those at risk include intravenous drug users, sexually active individuals, blood transfusion recipients, health care workers, and babies born to infected mothers.

Why, then, are government officials making hepatitis B vaccination mandatory for attending day care? Why have 42 states added the vaccine to their lists of immunizations required for attending school?

Since public health officials have failed to reach the high-risk populations, they are making hepatitis B vaccination compulsory for all children, even infants who clearly are not at risk. What better time to force medical care on people than during their first weeks of life, when they are too young to refuse the shots or to complain about side effects? The director of the U.S. Centers for Disease Control and Prevention's Immunization Program has publicly acknowledged that "infants are considered the easiest to immunize."

But what makes sense to the CDC doesn't necessarily make sense to a parent. Michael Belkin, who studied statistics and econometrics at the University of California at Berkeley and consults for some of the largest financial institutions on Wall Street, understands risk-benefit analysis. "Vaccination can be a lifesaver if an epidemic is raging," he says, "but in this case the risk of vaccination outweighs the risk of infants getting the disease. I believe the mandatory policy for hepatitis B vaccination should be completely revoked."

He's not alone. Across the country, parents are discovering that a vaccine of dubious benefit and unknown risk is being foisted on their children without debate. With hundreds of new vaccines under development, the fate of the hepatitis B vaccine is being closely watched. If it is successfully mandated for children in all 50 states, a precedent will be set for other vaccines against diseases that are not highly contagious and that can easily be prevented by abstaining from high-risk behavior.

Vaccine side effects, by contrast, are unpredictable. In January, ABC's 20/20 aired a segment about adults and children who suffered debilitating symptoms after receiving the hepatitis B vaccine. ABC reported that since the federal government began urging routine hepatitis B shots for infants in 1991, at least 274 newborns had died after receiving the vaccination. An additional 2,600 infants had suffered serious medical problems.

It is well established that a small percentage of children will suffer adverse reactions or die from routine childhood vaccines. That's why the federal government established the National Vaccine Injury Compensation Program in 1986. By 1997, the program had awarded nearly $1 billion to more than 1,000 families whose children suffered catastrophic reactions to government-mandated vaccines. For deaths, the awards are capped at $250,000 per death, plus attorney's fees and costs.

The risks specific to hepatitis B vaccination remain uncertain. Before the vaccine was approved by the Food and Drug Administration, researchers tested it in some 650 healthy infants and children up to 10 years old. After monitoring the subjects for five days following vaccination, the researchers concluded that "no serious adverse reactions attributable to the vaccine have been reported." But they conceded that, "as with any vaccine, there is the possibility that broad use…could reveal adverse reactions not observed in clinical trials." The insert in the vaccine package--which parents rarely see--lists a host of serious side effects that have been reported (in less than 1 percent of injections) since then, including arthritis, Guillain-Barre Syndrome, lupus, and multiple sclerosis.

Bonnie Dunbar, a cellular biologist at Baylor College of Medicine, began researching hepatitis B vaccine reactions after her brother developed autoimmune and neurological dysfunction following vaccination. She is investigating whether the vaccine tricks the immune systems of genetically susceptible people into attacking their own bodies. "I have worked in autoimmunity and vaccine development for over 20 years," she says. "After carrying out extensive literature research on this vaccine, it is apparent that the serious adverse side effects may be much more significant than generally known. Because it is not clear that adequate long-term follow-up information was collected in the clinical trial data, many of these effects might not have been observed."

Vaccine manufacturers and government officials deny that the hepatitis B vaccine causes debilitating diseases. They note that the vaccine has been administered safely to some 20 million children and adults nationwide. But patient advocacy groups are concerned that parents aren't being adequately informed about the possibility of severe reactions, however rare. "Without being provided with accurate and complete information about disease and vaccine risks," says Barbara Loe Fisher, president of the National Vaccine Information Center, "citizens cannot exercise informed consent, which becomes a human right when an individual considers undergoing a medical procedure that could cause injury or death." Fisher says that when parents whose children have suffered reactions challenge the public health authorities about vaccine safety, "they tell us we're only thinking of ourselves and our own children. They tell us we're selfish."

Since the late 19th century, public health officials have mandated vaccines to prevent the spread of highly contagious diseases, such as smallpox, measles, and diphtheria. In the 1905 case Jacobson v. Massachusetts, the U.S. Supreme Court confirmed the government's authority to require such vaccinations. Henning Jacobson challenged a 1902 Massachusetts law that required everyone to be vaccinated or revaccinated against smallpox in a community where the disease was known to exist. Having suffered a serious vaccine reaction as a child, Jacobson was worried about his safety and refused, arguing that his constitutional right to liberty superseded the public interest.

Writing for the Court, Justice John Harlan observed: "There is, of course, a sphere within which the individual may assert the supremacy of his own will, and rightfully dispute the authority of any human government, especially of any free government existing under a written constitution, to interfere with the exercise of that will. But it is equally true that in every well-ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand."

That argument still holds true for mandatory vaccination against diseases that are easily transmitted and therefore represent a threat to the general public. But with diseases like hepatitis B or AIDS, which are difficult to catch, carriers do not pose a clear and present danger to others. The case for mandatory vaccination becomes even weaker when the people receiving the shots are not carriers and will not pick up the disease unless they engage in high-risk behavior.

Today, U.S. vaccine policy is set by a 12-member Advisory Committee on Immunization Practices (ACIP) appointed by the secretary of health and human services. Once ACIP recommends universal vaccination for a disease, state officials routinely add it to the list of mandatory immunizations. Many states don't even allow for public debate on the risks and benefits of new vaccines. Some bypass the legislative process altogether, giving public health officials the authority to enforce ACIP's recommendations. Thus, 12 people have the power to determine which vaccines will be forced on millions of American children.

The lack of debate is especially troubling when you consider that more than 200 new vaccines are in the research pipeline, including vaccines for HIV, herpes, chlamydia--even cocaine addiction. In 1996 Peter Cohen, a researcher at the National Institute on Drug Abuse, presented a paper explaining that cocaine addiction could be viewed as an infectious disease. "A cocaine vaccine, currently under investigation by several laboratories, would be an innovative and exciting means of treating and preventing cocaine addiction," he wrote. "I propose to analogize cocaine addiction to an infectious disease which poses a major public health problem. This approach can provide an ethical and legal foundation on which we may begin to formulate a societal approach to the use of the cocaine vaccine." Given the emerging policy regarding hepatitis B, it is not hard to imagine public health officials arguing that all children should be vaccinated against cocaine addiction to protect the small minority who might one day have a problem with the drug.

People who rebel against this trend are increasingly looking for a way out. In all 50 states, children and adults with suppressed immune systems or other documented contraindications can obtain a medical exemption that allows them to enter day care, public school, or college without the usual vaccinations. All but two states (Mississippi and West Virginia) have a religious exemption, and 17 states have a philosophical exemption. The demand for "conscientious belief" exemptions is growing, with bills being considered in Texas, Illinois, and other states. But even when such exemptions are available, parents are rarely told that they can turn down vaccinations for their children without repercussions.

Some public health officials argue that parents who refuse to vaccinate their children should be held legally accountable for child neglect. The justification for mandatory vaccination, which used to be protecting the general public from disease carriers, has thus shifted to protecting children from parents who fail to take precautions recommended by the government's experts. But when it comes to guarding against diseases that children almost certainly will not get, parents should be allowed to weigh the risks and benefits.

Sue A. Blevins ([e-mail]) is president of the Institute for Health Freedom in Washington, D.C.