Mandatory Vaccinations Undergo a Year Under the Microscope.

From the WebMD Archives

Dec. 28, 1999 (Atlanta) -- Blind faith or abject fear. When it comes to controversy swirling around vaccinations, these are the two extremes. Somewhere in the middle, though, is where a battle approached fever pitch this year over mandatory vaccinations and the safety of those vaccinations.

"Why this year? I think it's a culmination of a reluctance by the institutions and the medical professions to deal with this problem, and it's reaching a critical mass," Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), tells WebMD.

What started in some quarters as a grassroots struggle turned into a groundswell this year in Washington, DC, and state legislatures around the country. Congressional hearings were held on the safety of vaccines. On the heels of these hearings, where citizens' groups testified to a list of ailments possibly associated with the hepatitis B vaccine, the government suspended the requirement for newborns to be immunized with the vaccine unless the mother has risk factors for that disease. The FDA has asked manufacturers to stop using mercury to protect vaccines against contamination, while proposing new regulations requiring pediatric studies of certain new drug and biological products.

And then there was the rotavirus vaccine, which was designed to fight the major cause of severe diarrhea in infants and small children worldwide. Rotashield, as it is called, was yanked from the market after reports of bowel obstructions that sickened some children, and possibly caused at least two deaths. Though an association was made between Rotashield and bowel obstruction, a final explanation is pending.

For parents already concerned about vaccine safety, this merely fanned the flames of the already raging fire. All 50 states require a battery of vaccinations before a child can enter school. But a growing number of parents are questioning that mandate -- some more vocally than others. And they have found allies among groups like the NVIC, which for nearly two decades has not only fought for more information about vaccines, but also for greater flexibility for parents to choose whether their children are immunized. At the center of this issue is a tug-of-war between individuals rights and public health.

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"I think the most important thing is to remember what vaccines are for: that the vaccine-preventable diseases are frequently quite serious with severe complications," Walter Orenstein, MD, director of the National Immunization Program for the CDC, tells WebMD.

By shining the spotlight just on safety, Orenstein says, "What often gets omitted is the benefit side, and vaccines have been so successful that [today's parents have never seen] many of these diseases. ... Some of them may never have even heard of some of them, but they're not a threat that's gone away. Except for smallpox, there is the potential for any of these disease to be resurrected."

He cites as an example the fact that, about 10 years ago, children weren't being vaccinated early enough for measles. "We had a large population of unvaccinated preschool children that were a fertile ground when there was a massive epidemic of measles," Orenstein tells WebMD. Over a 3-year period, 123 people died.

Thomas N. Saari, MD, a pediatrician who is also a member of the committee on infectious diseases for the American Academy of Pediatrics, cites the same example often to patients. He tells WebMD he tries to give his concerned patients as much information and background about the vaccinations as he can, following the rules of informed consent. But he says he also gives his patients a perspective from a time when vaccines weren't so prevalent.

"I try to give them a sense of what the world was like before we had immunizations to prevent the disease," he says. "We do get pretty complacent in this day and age because we don't see the diseases that the vaccines prevent because they do such a good job."

Saari tells his patients about the more recent measles outbreak. "It used to be said that 1 in a 1,000 children could be expected to die from measles, but here [in Wisconsin], it was 6 out of 2,000 [in the outbreak a decade ago], from a disease that was completely preventable."

And Saari also brings up the public health issue, the "community obligation" of parents. He tells WebMD, "we immunize our children as much to prevent our child from catching a disease, as much as preventing our child from giving another child disease."

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Fisher, who is a member of the FDA's Vaccines and Related Biological Products Advisory Committee, says her organization, the NVIC, is not anti-vaccine. "We have always been about reforming the system, not destroying the system," she says, pointing out that her group's "mantra" is "show us the science, and give us a choice."

According to Fisher, controversy around vaccines is a very complex issue, with many shades of gray. "We have to take a sensible, reasoned, balanced approach to vaccination and not this militaristic, one-size-fits-all, 'the policy is more important than the individual' [approach]," she says.

Fisher would like to see more scientific testing of vaccinations before they hit the market, to determine the "biological mechanism" of the drug, and perhaps how it could cause injury or death to some individuals, no matter how few. "Everybody is not going to respond the same way," she says.

She would also like to make sure that parents are educated so they can monitor their child after vaccination to look for any health problems. And, along with other advocates, she would like mandatory vaccination laws to become more "flexible."

Jane Orient, MD, director of the Association of American Physicians and Surgeons, a 4,000-member doctor group, agrees. "Most of our members think that vaccines in general are a good thing, but we're opposed to mandatory vaccines. We believe that should be between the physician and the patient, and that decision should be made on an individual basis," she tells WebMD.

What are the risks, beyond immediate adverse reactions? Fisher admits there's no proof of cause and effect with some of the claims but a "tremendous amount of anecdotal evidence" pointing to an increase in autism, attention deficit/hyperactivity disorder, asthma, juvenile arthritis, diabetes, and "chronic immune and neurological dysfunction," she says.

Mainstream medical organizations, like the American Academy of Pediatrics and the American Medical Association, back the status quo. Earlier this year, U.S. Surgeon General David Satcher, MD, acknowledged while testifying before a congressional committee that vaccines "have risks," but the government is increasing spending for research into safety and tracking. Satcher said that vaccines are, from a risk-benefit perspective, "perhaps the safest and most efficacious medical intervention of our time."

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The CDC has chosen the impact of vaccines universally recommended for children as one of the century's 10 greatest public health achievements. Orenstein tells WebMD that there are some more immediate steps being taken by the government to improve safety. He mentions the removal of the rotavirus vaccine, no longer recommending the "whole cell" pertussis vaccine, and no longer recommending the oral polio vaccine.

Instead, Orenstein says the inactivated-virus polio vaccine, which may be marginally safer, will be used to get rid of the handful of polio cases left. "That's an example of making the schedule, which was already safe -- about one case of polio in about 2.4 million doses, [and] very few programs have that margin of safety -- even safer. In essence, the federal government has been willing to pay $3 million to prevent a single case of polio, since the inactivated [vaccine] is more expensive," Orenstein tells WebMD.

"The immunization system is evolving," he says, "and as we learn more, we make changes. We make changes by perhaps adding more doses, if we find more doses of a certain vaccine are needed for efficacy, and we make changes if there are ways of increasing the safety while maintaining high levels of protection against vaccine-preventable diseases. [T]his is an ongoing process.

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