Time to get tough? States increasingly offer ways to opt out of vaccine mandates
■ Too many exemptions have been seen as a risk to public health. But a push to crack down might do more harm than good.
By Kevin B. O'Reilly amednews correspondent — Posted Sept. 8, 2008
Measles are coming back. The Centers for Disease Control and Prevention reported that measles outbreaks have reached a peak not seen since 1996. By late August, 131 cases had been confirmed in 16 states.
Almost half of the cases occurred in children who had not been vaccinated because their parents claimed religious or personal exemptions to vaccine mandates.
"This measles outbreak may be a warning shot," said Paul A. Offit, MD, chief of the infectious diseases division at the Children's Hospital of Philadelphia. "We now have communities that have a lack of herd immunity. That puts children at risk."
Other physicians and public health experts are echoing Dr. Offit's concern. They say states are making it too easy for parents to exempt their children from the vaccines required for school entry. As scientifically unfounded information about vaccine risks swirls around the Internet and among parents, experts say the exemption rate is bound to grow.
But others worry that toughening the opt-out process, or just talking about mandates, could lead to an even greater loss of public trust in the immunization system.
National immunization rates are high, ranging from 85% to 93%, depending on the vaccine, the CDC said. But in states such as Minnesota and Colorado, the nonmedical opt-out rates exceed 5%. And research shows that the easier the exemption process, the more likely parents are to use it.
The 28 states that have religious-only exemptions saw their opt-out rates remain stable between 1991 and 2004, according to an Oct. 11, 2006, study in the Journal of the American Medical Association. But the 20 states that also allow personal-belief opt outs saw exemptions grow by 61%, to 2.54%, during the same period. Meanwhile, the 15 states with the easiest exemption process -- one parent's signature -- saw their rate jump 48%, to 2.51%, during that time.
These exemptions were not without consequences, according to the study. The religious-only opt-out states had rates of pertussis two times lower than did states that also granted personal-belief exemptions. The hassle-free exemption states had pertussis rates 90% higher than the states where opt outs are the hardest to obtain.
Exemptions: Too many, too easy?
Francesco "Chek" Beuf, MD, is a pediatrician in Boulder, Colo., where vaccination rates are on the decline. Only 62% of 2-year-olds in Boulder County received the pertussis vaccine in 2005, according to health officials, and there have been 510 pertussis cases since 1999.
A Dec. 27, 2000, JAMA study found that exempted children in Colorado -- where signing a form is all it takes for exemption -- were 22 times more likely to contract measles and about six times more likely to get pertussis.
Colorado's anything-goes exemption system "stinks," Dr. Beuf said. "It means that people don't feel social pressure to get their kids vaccinated. ... It's given too many people a blank check to just dither around the subject."
Dr. Beuf favors getting rid of the state's philosophical exemption altogether. A more modest Boulder County Medical Society resolution would limit the number of personal-belief exemptions allowed statewide each year, though it does not specify a cap. The resolution will be considered at the Colorado Medical Society meeting in September.
Other states make it tougher for parents who refuse vaccines. New York allows religious exemptions and authorizes school officials to question parents about their beliefs before letting children enter school unvaccinated.
Last year, Ron and Rita Palma of Bayport, N.Y., were forced to vaccinate their two sons following a two-hour interview with a lawyer for the local school. The Bayport-Blue Point Board of Education judged the Palmas to be insincere in professing a religious opposition to vaccines.
"How can anyone judge another person's belief in God?" Rita Palma said in a news release issued by My Kids, My Choice, the vaccine-refusal organization she heads.
A New York State Assembly bill that would add a philosophical exemption to the state's vaccine mandate law is stuck in committee. The American Medical Association has policy opposing religious or philosophical exemptions from school-entry immunization mandates. Only two states, Mississippi and West Virginia, do not permit either exemption.
Model law: Can both interests be met?
Some physicians are promoting another approach they believe successfully balances the public health imperative with respect for religious minorities and vaccine skeptics.
A model school-immunization law to allow religious and personal-belief exemptions has been drafted by physicians and public health and legal experts from the Arkansas Medical Society, the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health, and the Centers for the Law and the Public's Health at Johns Hopkins and Georgetown Universities.
Under the plan, parents would have to obtain a signature from a licensed physician or health department official to prove they received counseling about the risks and benefits of vaccines. They also would be required to present a signed, personal statement demonstrating how long they have held their beliefs and that they understand the risks and benefits of vaccines.
A parent's decision to opt out "should be based on deeply held beliefs, not just a little doubt or uncertainty or the easiest path," said Neal A. Halsey, MD, director of the Institute for Vaccine Safety, which helped draft the model law.
"If somebody really doesn't want to immunize their child against the measles, we want to make sure they're fully educated about the consequences. They should have to go through a rigorous process," Dr. Halsey said.
Many pediatricians, infectious disease experts and ethicists said the model law is fair and should be adopted in one or two states to gauge its effect on opt-out rates. Arkansas enacted a more lenient version of the proposal in 2004.
One of the model's supporters is Douglas S. Diekema, MD, MPH, director of education at the Treuman Katz Center for Pediatric Bioethics at the Children's Hospital and Regional Medical Center in Seattle. Washington allows religious and philosophical exemptions and requires parents to sign a form.
The measure would "achieve improved vaccination rates and still allow people who believe strongly to opt out," Dr. Diekema said. "The bottom line is that by opting out, you're putting other people at risk, and you shouldn't be able to do that so easily."
But critics of vaccination are also critical of requiring face-to-face counseling with a physician or public health official.
"I don't like the idea of making doctors the gatekeepers," said Barbara Loe Fisher, president of the Vienna, Va.-based National Vaccine Information Center, which opposes mandatory immunization. "In the end, it should be the parent's decision. It should not be subject to approval by doctors sitting in a position of authority."
Mandates: How many, how strict?
Some experts draw distinctions between the types of vaccines that states mandate. For diseases such as polio or measles that are highly infectious in a school setting and could be epidemic, mandates -- with no religious or personal exemptions -- are ethically and legally justified, said Sigrid Fry-Revere, PhD, president of the Center for Ethical Solutions, a bioethics think tank in Waterford, Va.
But Fry-Revere said other vaccine-preventable diseases, such as hepatitis B or the human papillomavirus, do not meet that standard because they are not transmitted through casual contact.
"Either the mandate is justified or not. And if it is justified, why create exceptions?" she said. "The exemptions are deceptive."
Dr. Diekema agreed that states should be more careful when choosing which vaccines to mandate, and distinguish between immunizations that have value as preventive medicine and those aimed at diseases easily spread in schools. "There's nothing about going to school that inherently puts people at risk of contracting HPV."
The huge public backlash last year against Merck & Co.'s lobbying effort to persuade states to mandate its HPV vaccine, Gardasil, has left many gun-shy on mandates.
Pediatrician Dr. Beuf said restricting exemptions could backfire. "Tougher mandates might improve the number of immunized kids, but they also could get so many people angry that it would be a difficult situation."
Educational efforts are under way. In late May, 15 organizations, including the American Academy of Pediatrics and the AMA, met and agreed to join together to promote the benefits of vaccines. The coalition, known as the Immunization Alliance, is preparing materials for distribution in the fall.
"The biggest issue is education," Dr. Beuf said. "We need to turn [immunization] into a socially positive issue rather than a socially negative issue."