Jon VanZile
Thursday, March 22, 2007

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In February when Texas governor Rick Perry touched off a national controversy after signing an order mandating that all middle-school-aged girls in Texas get the HPV vaccine before entering school, he set off a larger debate about the public policy of government require vaccines.

Today, vaccination is routine as dental cleaning. Fully 82 percent of all children in the United States have already received 11 doses of vaccines against 6 diseases before entering kindergarten, while 76 percent have received the full recommendation of 14 doses against 8 diseases. Vaccine policies differ from state to state.

At first blush vaccine policies appear to be good ones. For example, the HPV vaccine protects against four strains of the human papillomavirus, which is sexually transmitted. These four strains of HPV are responsible for about 70 percent of cervical cancers and 90 percent of genital warts.

Not everyone was happy with Perry's order.. Family groups such as the Traditional Values Coalition, the Family Research Council, and the Concerned Women for America rapidly denounced forced vaccination of young girls with the HPV vaccine.

They argued that forcing vaccination against a sexually transmitted disease, as opposed to an infectious agent like measles, is not an appropriate decision for schools and state public health departments. Rather, it is a decision better left to parents.

Other critics noted Perry's ties to Merck, which produced the HPV vaccine. According to press reports, Merck donated $5,000 to Perry's reelection, while his former chief of staff is now a paid lobbyist for the drug giant. And Perry was not alone as a target for Merck—the company pursued a muscular lobbying effort to fast-track approval of the vaccine at the Food and Drug Administration (FDA), secure a universal use recommendation from the CDC and lobby individual states to mandate the vaccine. Currently, dozens of states are considering mandating the HPV vaccine.

However, a growing number of critics wonder if vaccines such as the HPV are really necessary and potentially dangerous.

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Question Authority

The HPV vaccine rebellion marks the first time that large numbers of parents have questioned the wisdom of a new vaccine. Before the HPV vaccine, new vaccines were regularly introduced and quietly mandated by states across the country. These mandates were enthusiastically supported by public health organizations including the FDA, the CDC, the American Academy of Family Physicians, and the American Academy of Pediatrics.

The CDC today recommends an aggressive immunization schedule beginning at birth with vaccination against hepatitis B. Over the next 12 years, children are supposed to receive a constellation of more than 50 vaccine doses to immunize them against 15 diseases, including HPV.

"In the last 25 years, we've gone from 23 doses of 7 vaccines to more than 50 doses of 15 vaccines by age 12," says vaccine-safety activist Barbara Loe Fisher, founder of the non-profit National Vaccine Information Center. "At the same time, we have seen an explosion in allergies, asthma and autism. Something has happened. I can't say it's all due to vaccines, but I think it's a question that needs to be answered."

So far, that's easier said than done. Until recently, even asking question about the long-term safety of vaccines was enough to destroy a physician's career.

"Vaccination is considered a sacrament of modern medicine," says Dr. Richard Moskowitz, Ph.D., M.D., a Harvard-trained doctor who has written extensively on the possible connection between vaccines and chronic diseases. "It's considered beyond the pale to question the concept of vaccination. You might question the validity of this or that vaccine, but you can't question the concept."

There is no doubt that vaccines work to prevent disease. Victories over polio and smallpox, terrible diseases that affected up to 50,000 children per year before the age of vaccination, are among the greatest triumphs of modern medicine.

Risk-Benefit Analysis

However, today's vaccine arsenal protects kids from diseases that were once common and, in most cases, caused no long-term harm, including chicken pox.

Among vaccine-safety advocates, there is the nearly uniform opinion that the risks of forced, mass immunization programs outweigh the benefits, and America's children may be suffering from a massive epidemic of disease because of it.

According to vaccine-safety advocates, the danger of vaccines comes from loading a child's developing system with viral material that provokes a strong immune system response, in addition to the various preservatives used in vaccines. Just like adults react differently to prescription drugs, they argue that children react individually to vaccines, and some children may have genetic or biological factors that put them at risk from vaccination.

In calling for better data, vaccine safety advocates are striking at the heart of America's mass immunization program. In fact, no well-designed, large scientific study has ever compared the long-term health outcomes of children who receive multiple vaccines versus children who receive few or no vaccines.

"They'll never do these studies," Loe says. "Because they already know the answer. Kids who are not highly vaccinated hardly get sick. They're immune systems are so incredibly responsive. These children today are tremendously compromised. . . . We're taking away the ability for the developing child to experience the environment as previous generations experienced it. We don't know if it's smart to do that."

But a head-to-head vaccine safety study in the United States would be impossible because all states mandate vaccination before children can enter school. "The purpose of vaccinating children is not to experiment on children, but to help them," says Daniel Salmon, Ph.D., a researcher with the Johns Hopkins Bloomberg School of Public Health who has extensively studied vaccine safety in the United States. "When a vaccine is licensed, you have a fairly good level of confidence in its safety."

However, when public health advocates point to studies proclaiming that vaccines are safe — that they are not linked to autism, asthma, allergies, childhood rheumatoid arthritis or any other of the diseases that are on the rise — they are usually using population or short-term safety studies used during the drug-approval process

"We've never been against vaccines," Loe says of her group. "We're for safe and effective vaccines for anyone who wants to use them, and we're opposed to forced vaccinations. It may be that we should select a few vaccines for a few of the deadliest diseases."

Pressure to Mass Vaccinate

Voluntary vaccination, however, runs against the concept of "herd immunization." This means that enough people receive vaccine that outbreaks are impossible. Generally, the goal of any vaccination program is 100 percent compliance, which explains why public health authorities strongly support mandatory vaccination.

It's highly unlikely that the United States will change its vaccination policy absent widespread and vocal protests, in part because of the political and financial pressure driving vaccination. Overall, the vaccine industry in the United States generates about $10 billion in annual revenue. Because of increased infant and flu vaccination, the industry has almost doubled in the last five years.

Before a vaccine gets to market, it must first be approved by the FDA, which evaluates its safety profile and its ability to establish immunity. It is then evaluated by the Advisory Committee on Immunization Practices, which makes a recommendation to the CDC. If the CDC recommends a vaccine for universal use, state health boards usually mandate the vaccine for all school-age children.

This process, however, can be manipulated both by drug companies that stand to make billions of dollars from national vaccine programs and by physicians, who may believe in vaccines as an article of faith and also have a financial interest in promoting vaccines.

Rep. Dan Burton, R-Ind., explored this issue in a series of Congressional hearings focused on whether mercury used as a preservative in some vaccines contributed to autism.

"These advisory committees and panels consist of people who may have a vested interest in getting the vaccine into the marketplace," Burton says. "The FDA has never turned down an advisory committee recommendation on vaccines. I think we ought to make sure the FDA properly reviews the advisory committee recommendations and reviews financial disclosure forms from the people on these panels."