Of all the preventative treatments ever developed through science- and evidence-based medicine, vaccines have arguably saved more lives, prevented more illness and disability, and in general alleviated more suffering than any single class of treatments or preventative measures throughout history. Given the obvious and incredible success of vaccines at decreasing the incidence of infectious diseases that used to ravage populations, it seems incredible that there would be such a thing as an antivaccine movement, but there is. Indeed, when I first encountered antivaccine zealots on the Usenet newsgroup misc.health.alternative about ten or twelve years ago, as a physician I really had a hard time wrapping my head around the fact that such people existed. No doubt the same is true of many physicians, who take the scientific evidence for the safety and efficacy for vaccines for granted. However, I am a cancer surgeon, and I do not treat children; so until I discovered antivaccine rhetoric on the Internet I was blissfully ignorant that such views even existed. Other health care professionals knew better. Pediatricians, nurses, and any health care professionals who deal with children and the issue of vaccinations know better, because they face antivaccine views on a daily basis. It is because of the incredible importance of vaccination and the danger to public health the antivaccine movement represents that we at Science-Based Medicine write so frequently about vaccines and the antiscientific, pseudoscientific, and misinformation-packed fear mongering about vaccines that is so prevalent today.

The success of vaccination campaigns has recently been endangered by a number of factors, in particular the antivaccine movement. Because of various groups opposed to vaccination, either for philosophical reasons or because they incorrectly believe that vaccines cause autism, neurodevelopmental disorders, sudden infant death syndrome, and autoimmune diseases, among others, one of the most potent tools for encouraging high rates of vaccine uptake, school vaccine mandates, have come under attack. Alternatively, increasing numbers of parents have taken advantage of religious or philosophical exemptions in order to avoid the requirement to have their children vaccinated prior to entry to school. As a result, of late some states with lax vaccination requirements have begun to try to tighten up requirement for non-medical vaccine exemptions. The arguments used by the antivaccine movement against such legislation are highly revealing about their mindset, in particular their attitude towards issues of informed consent, which I will discuss a bit. But first, here’s a little background.

Antivaccinationism throughout history

The success of vaccination campaigns depends upon as many members of an at-risk population as possible being vaccinated in order to achieve herd immunity. Herd immunity (also known as community immunity, a lovely rhyme) been discussed on this blog many times, most prominently by Drs. Mark Crislip and Joseph Albietz. Basically, when a sufficiently large percentage of the population is vaccinated against a disease, even those not immune to the disease obtain a measure of protection against infection because the immunity of a large percentage of the population prevents the infectious agent from being readily spread from person to person. The agent thus never gets a “foothold” in the community, and the greater the proportion of the population vaccinated the less the chance of a susceptible individual coming into contact with an individual carrying the infection. Herd immunity is very important because it helps to protect population members who can’t be vaccinated for whatever reason, be it immunodeficiency or other medical reason or because they are too young to be vaccinated. Vaccines aren’t perfect. Even highly effective vaccines only protect 90 to 100% of the vaccinated population in the case of an exposure to the infectious agent vaccinated against. The precise percentage of the population that needs to be vaccinated to achieve herd/community immunity varies depending upon the efficacy of the vaccine and the infectiousness of the disease being vaccinated against, but a good, serviceable ballpark estimate is usually somwhere in the 90% range.

Herd immunity is the reason why it is so important to vaccinate as large a percentage of the at-risk population as possible. To this end, public health officials have at times tried a number of strategies, ranging from cajoling to compulsory vaccination. Legislating compulsory vaccination, in particular, has traditionally been problematic, for almost immediately after vaccines were invented and public health officials started looking for ways to increase vaccine uptake rates, in response have sprung up antivaccination movements. For example, in the U.K. the Vaccination Act of 1853 ordered mandatory vaccinations for infants up to three months old, with failure of parents to do so punishable by a fine or imprisonment, a requirement that was extended to age 14 by the Vaccination Act of 1867. The 1853 act immediately provoked violent riots in Ipswich, Henley, Mitford, and several other towns, and resulted in founding of the Anti-Vaccination League later that same year. Over the next few decades, in response to compulsory vaccination laws a large number of antivaccination books, journals, and tracts appeared. The titles of these books and journals, at least, were more honest than titles of similar websites today. For instance, there were the Anti-Vaccinator (founded 1869), the National Anti-Compulsory Vaccination Reporter (1874), and the Vaccination Inquirer (1879). Meanwhile, similar movements flourished elsewhere in Europe and the United States, challenging such laws as infringements on personal liberty. Ultimately, in England, the Vaccination Act was amended to allow exemptions for parents, based on conscience, which introduced the concept of “conscientious objector” into English law.

A different strategy to achieve high rates of vaccination is the use of vaccine mandates. School vaccine mandates differ from laws requiring vaccination in that no one from the state will hunt parents down to force them to vaccinate. However, if parents want to take advantage of state services, such as public schools, for their children or if they want to use services that place a lot of children together (such as day care facilities) they have to have their children vaccinated. This is a practice with very old precedent. For example, in 1827 Boston became the first city to require parents of children enrolling in public school to present evidence of vaccination against smallpox. The trend continued, as described in this review of school vaccine madates:

The Commonwealth of Massachusetts incorporated its own school vaccination law in 1855, New York in 1862, Connecticut in 1872, and Pennsylvania in 1895. Other Northeast states soon passed their own requirements. The trend toward compulsory child vaccination as a condition of school attendance eventually spread to states in the Midwest [e.g., Indiana (1881), Illinois and Wisconsin (1882), Iowa (1889)], South [e.g., Arkansas and Virginia (1882)], and West [e.g., California (1888)], though not without considerable political debate.

School vaccine mandates, although they were opposed by antivaccination leagues from the beginning, tended to provoke less virulent opposition and better compliance, making them not only politically more palatable, but more effective. However, of late, the effectiveness of school vaccine mandates has been weakened by a steady expansion of non-medical exemptions, in particular religious or philosophical exemptions. Forty-eight states currently allow religious exemptions that vary in requirements, from parents simply signing a form stating that vaccination is against their religion to allowing exemptions only to religions that have a history of opposing vaccination, such as Christian Scientists and Jehovah’s Witnesses. Twenty states currently permit philosophical exemptions, in which parents must declare a personal belief against or philosophical objection to vaccination. Usually, parents must file a form, ranging from just once to annually, with their school district stating their personal objection to vaccination. Not surprisingly, in states that allow personal belief exemptions they are the most commonly invoked reason by parents to refuse vaccinating their children. Even in states that allow only religious exemptions, however, parents are not above lying about their religion in order to obtain a vaccine exemption.

California responds to the increasing use of personal exemptions

Over the last couple of decades, the percentage of parents claiming personal exemptions to vaccination has more than doubled. In California, a state with a particularly lax personal exemption law that only requires that the parent sign a form stating that they have a personal belief against or philosophical objection to vaccination, although statewide the percentage of children with parents claiming the personal belief exemption remains low (2%), there are schools where exemption rates are as high as 58% (one kindergarten reported a 76% exemption rate) serving as incubators for outbreaks of measles and other contagious diseases. After all, unvaccinated children have a 23-fold higher risk of contracting pertussis and a 35-fold higher risk of contracting measles than vaccinated children. Unfortunately, the non-vaccinating populations tend to cluster, and their refusal of vaccines leads to there being areas with large pockets of unvaccinated children, ripe for outbreaks of vaccine-preventable diseases.

Part of the problem in California is that philosophical exemptions are so easy to obtain that they are actually easier to obtain than it is for parents to have their children vaccinated according to California requirements for school entry. It is, in effect, so easy to obtain a personal belief exemption from vaccination requirements for school entry that even parents with no strong feelings who are simply too harried to claim this exemption just to make their lives a little easier. Just sign a piece of paper. That’s it.

To try to make sure that parents who refuse vaccines on a personal belief basis do so with full informed consent and to make it just a bit more difficult to obtain such exemptions, Assemblymember Richard Pan (D-5th District), who also happens to be a physician, introduced California bill AB 2109. (According to Liz Ditz, as of March 24, the bill is still in the Assembly Health Committee.) The bill is very simple and not a major change from California’s current lax policy. Basically, in addition to signing a personal belief exemption form, if AB 2109 is passed, parents will be required to obtain a signed form from a pediatrician stating that they have been counseled on the risks and benefits of vaccines. The law would, in essence, require that the parents make such a monumental decision only after having had a physician provide them with informed consent, so that they understand the potential consequences of not vaccinating, as well as the risk-benefit ratio for vaccination. The text of the bill can be found here.

Unfortunately, even so mild a change in the law designed to boost vaccination rates has not gone unnoticed among the antivaccine movement.

The antivaccine movement and its sympathizers react by advocating misinformed consent

I’ve discussed the concept of “misinformed consent” multiple times before. Quacks in general, particularly the “health freedom” movement proclaim their dedication to “informed consent.” “All we’re asking for,” they will say, “is informed consent.” The antivaccine movement in particular demands “informed consent” about vaccines. Be it founder of the National Vaccine Information Center (NVIC) Barbara Loe Fisher, the bloggers at the antivaccine crank blog Age of Autism, or any of a number of antivaccine warriors, demanding “informed consent” seems to be every bit as much of the antivaccine arsenal as the “toxins gambit” or ranting about “fetal cells” in vaccines. None of this is to try to say or even imply that informed consent isn’t incredibly important. It is critical to everything we do in medicine, both in clinical practice and research in the form of clinical trials. It is, quite correctly, considered a major failure when adequate informed consent is not given, and when the failure to provide informed consent is intentional or comes about through neglect it’s considered highly unethical. Medical ethics demands that patients be aware of what it is they are getting as well as what the potential benefits are relative to the potential risks, and that they have the freedom to choose to undergo or refuse the proposed therapy.

However, what the antivaccine movement means when its representatives demand “informed consent” resembles true informed consent only by coincidence–and, let’s be frank, not even then. In fact, as Todd points out, the actions of the antivaccine movement are profoundly inconsistent with a real desire for real informed consent, and California Bill AB 2109 is a golden opportunity for the luminaries of the antivaccine movement to prove that they support informed consent. As he also put it, “Parents are still free to put their children and their communities at risk of disease outbreaks based on personal opinions rather than facts. They just aren’t allowed to be quite as lazy about it any more.”

Unfortunately, the antivaccine movement has rallied not for AB 2109, but against it. Barbara Loe Fisher, all her protestations for “informed consent” notwithstanding, has issued what is in essence a call to arms to her fellow antivaccinationists to try to defeat the bill. It’s full of appeals to “personal freedom,” claims that doctors would not sign such forms, and the like:

AB2109, introduced by Assembly Member Richard Pan, who himself is a pediatrician, would impose these additional costly and time consuming burdens on parents wanting to use a personal belief exemption to:

  1. pay for an expensive appointment at a medical doctor’s office to be given vaccine risk and benefit information that is already available online for free; and
  2. jump through the bureaucratic hoops of obtaining yet additional new forms provided by the Department of Public Health which state that the health care practitioner has provided risk and benefit information to the parent; and
  3. find a health care provider actually willing to take the appointment and then sign the new forms within 6th months of starting school for the exemption to be valid.

This raises many questions legislators need to answer including:

  • How will the state pay for all these extra required office visits for families on public assistance and for the kids of state employees who have their health coverage provided by the state?
  • What happens to a parent who can’t find a provider willing to make these types of appointments and then sign the form?
  • What will stop doctors from using this law to deny access to philosophical exemptions? It is already hard enough for families to find providers who are willing to just treat children in their practice at all when they deviate from the required vaccination schedule.

Then, to hammer home the connection between quackery and antivaccine beliefs, the NVIC adds these reasons for opposing AB 2109:

  • Especially in California, many families utilize health care providers not reliant on pharmaceutical drugs and vaccines, and only practitioners part of the pharmaceutical paradigm or medicine are allowed to provide the information and sign the form under this bill.
  • AB 2109 discriminates against families utilizing complementary and alternative medicine by forcing them into paying money to a medical practitioner they wouldn’t otherwise use who is already philosophically opposed to the parent’s personal and religious convictions regarding vaccination.

Barbara says that as though prodding parents who take their children to quacks to take them to a real doctor for just one visit is a bad thing. Of course, it’s “health care providers not reliant on pharmaceutical drugs and vaccines” who tend to promote antivaccine beliefs. Of course, I expect such nonsense from someone like Fisher. I don’t expect such nonsense from a physician. In fact, call me naive, way too optimistic, or just someone who falls into the occasional temptation to defend his tribe too much, but I don’t expect nonsense this ridiculous even from someone like Dr. Jay Gordon.

Or Dr. Robert Sears.

Unfortunately, I was quite wrong. Dr. Sears has joined Barbara Loe Fisher’s voice against AB 2109 by writing an editorial that was published first on that other wretched hive of scum and antivaccine quackery, Mothering.com, entitled California Bill AB2109 Threatens Vaccine Freedom of Choice. Not surprisingly, two days later Dr. Sears crossposted the very same article on the original wretched hives of scum and quackery, The Huffington Post. His reasons for being opposed to AB 2109 are virtually indistinguishable from the reasons posted at the NVIC website, right down to Dr. Sears claiming that doctors won’t sign the form:

However, what gravely concerns me is that some doctors will refuse to sign this form. I know how doctors think. Many doctors strongly believe that vaccines should be mandatory, and that parents should not have the right to decline vaccines. Some doctors are willing to provide care to unvaccinated kids, despite this difference in philosophy. But now the power over this decision will be put directly into doctors’ hands. He or she can simply refuse to sign the form. Doctors who oppose vaccine freedom of choice have been frustrated for years over this issue. Finally, they will have the power to impose their beliefs on their patients. Patients will be forced to find another doctor to sign the form, submit to vaccines, or get kicked out of public school.

And, of course, there’s the question of liability fears, which leads Dr. Sears to state that he knows for an “absolute fact” that some doctors will not sign the form “out of principle or fears of liability.” How he knows this “for an absolute fact” he doesn’t say. The only part where Dr. Sears makes a modicum of sense is that some doctors might be reluctant to sign the form for a child based on a single visit, particularly when it’s obvious that that’s the only reason the parents brought the child in to be seen and evaluated. That might be so for some doctors, but how many doctors do sports physicals, insurance physicals, physical exams for workers’ compensation, and the like, even though they know that the patient probably won’t come back to see them again? How many physicians in California, for that matter, refuse to sign medical exemption forms for vaccination? Not very many.

If you don’t believe me that Dr. Sears is cribbing from the NVIC playbook, though, read this passage:

Natural and alternative health care providers can NOT sign the form; it must be a “regular” medical professional. Some families only see naturopathic or holistic health care practitioners instead of pediatricians. These families will have a difficult time getting the form signed.

Again, Dr. Sears, you say this as though that were a bad thing. Also note how his language is almost indistinguishable from that of the NVIC. Getting kids whose parents are using quacks for their primary care physicians brought in, even just once, to see a real doctor can only be a good thing. Here’s a hint for Dr. Sears: It’s not a good thing when passages of your blog post look as though they’ve been directly cribbed from an NVIC position statement! If you don’t want to be perceived as antivaccine, then don’t use NVIC arguments in language that could fit right in on the NVIC website without raising a single eyebrow of Fisher’s fans. Besides, there are plenty of antivaccine-sympathetic (or even antivaccine-friendly) doctors like yourself, Dr. Janet Levitan (who, it should be recalled, is perfectly happy to encourage parents to lie about their religious beliefs in order to obtain religious exemptions from vaccination for their children), or Dr. Jay Gordon out there, who will probably be more than happy to sign such forms after having provided a generous portion of misinformed consent to the patient’s parents.

In fact, it wouldn’t surprise me at all if one result of this law would be the creation of a cottage industry of antivaccine-sympathetic pediatricians advertising their willingness to sign philosophical exemption informed consent forms in California with only the most perfunctory of visits. It could be quite the little cash cow. Unfortunately, requiring that parents see a real pediatrician for real informed consent is no guarantee that they will actually get real informed consent based on science, but it makes it more likely. Certainly it’s far more likely that parents will get something resembling informed consent if they go to a real pediatrician than if they go to a chiropractor, naturopath, or homeopath. Moreover, chances are that insurance will pay for most, if not all, of any visit required to obtain a vaccine exemption informed consent form from a physician. It’s largely a win-win situation, although Dr. Sears doesn’t see it that way. In fact, he doesn’t even seem to agree with the purpose of the bill, namely to try to increase vaccination rates:

The sponsors of this bill may have some good intentions, as their primary “public” reason for the bill is to make sure that parents who don’t vaccinate their children are making an informed medical decision under the guidance of their doctor. But it isn’t difficult to see the REAL reason for the bill: to increase vaccination rates in our state by making it more difficult for parents to claim the exemption.

Again, Dr. Sears, you say that as though that were a bad thing. Or, to put it another way, why don’t you think it’s a good thing to try to increase vaccination rates? Certainly that seems to be the implication of your argument, that the real “hidden” reason for AB 2109 (hidden presumably because it’s so nefarious) is to increase vaccination rates and decrease the number of pockets where there are schools in which 50-70% of the children aren’t vaccinated because their parents claimed personal belief exemptions. Except that the reason isn’t exactly hidden; the sponsors and supporters of AB 2109 are quite explicit that the goal is to increase vaccine uptake rates. They’re intentionally trying to make it a little more difficult to get a philosophical exemption approved. Hard core antivaccinationists will take that extra step; those who are more lazy than actually committed to not vaccinating their children will probably not. In any case, the real reason that Barbara Loe Fisher, Dr. Sears, and the rest of the antivaccine movement don’t like AB 2109 is exactly because it makes it a little harder to get a philosophical exemption. More importantly, it will require some parents to take their children to a physician and have a talk about vaccines and maybe—just maybe—get a science-based perspective and something approximating real informed consent. Dr. Sears points out that by the time a parent has made up her mind to get an exemption that talking to a physician about it will probably not change her mind. That’s probably true, but the current state of affairs in California is that it’s so easy to get a philosophical exemption that it’s much easier than actually bothering to get one’s children vaccinated.

Personal belief exemptions from vaccination in the 21st century

A strictly public health standpoint results in the conclusion that non-medical exemptions do nothing other than decrease vaccination rates and degrade herd immunity. Thus, from a strictly scientific standpoint, eliminating all non-medical exemptions to school vaccine mandates would be the most effective means of making sure that children who attend public school are fully vaccinated. Moreover, there is no Constitutional issue involved in doing so, either. We do not, however, live in a world where only scientific considerations prevail. As various SBM bloggers have pointed out on numerous occasions, science-based medicine is based in science, but it is not, strictly speaking, pure science. Science informs and guides what we recommend as treatments, but sometimes other factors play a role. School vaccine mandates, I believe, are just such a situation when other factors cannot be avoided, at least in most states. We must accept that we live in the real world, and in the real world religious and philosophical exemptions to vaccination are not going away.

The reason is that, in the U.S. at least, there is a long history of being wary of government mandates, particularly in health care. Compulsory “anything” laws tend to be very politically unpopular, as has been so thoroughly demonstrated by the political resistance to the Patient Protection and Affordable Care Act (or, as its opponents sneeringly refer to it, Obamacare), for example. Vaccine mandates that go too far politically, as scientifically justified as they may be, have the potential to provoke major backlashes against vaccine programs, as compulsory vaccination laws for all children did in the 1800s in England, Europe, and the U.S. Going too far, even for public health, risks a very real backlash, and even supporters of mass vaccination campaigns (myself included) worry about government overreach and intrusion into personal medical issues. That is probably why only two states do not allow for either religious or philosophical exemptions, and in at least one of those states (West Virginia) there is a movement to allow such exemptions. It is also why it is unlikely that religious and personal belief exemptions will ever be eliminated. We can and should, however, decrease greatly the ease with which such exemptions can be obtained, as California is trying to do through AB 2109.

We can, however, apply a rule to religious and philosophical exemptions by twin approaches. First, vaccination should be free. Parents who cannot afford it or who are uninsured should be eligible for state-funded vaccination. This is true to varying degrees in many states, but it should be universal. Second, I support a general principle described by Douglas S. Diekema, MD, MPH, at the University of Washington, published in a recent issue of the New England Journal of Medicine:

Although eliminating exemptions for religious and personal beliefs may seem logical, such efforts would encounter substantial resistance and probably increase antivaccinationist fervor. Some states might improve immunization rates by addressing the ease of obtaining exemptions and enforcing school-entry requirements. The exemption process should not be easier or less costly than the vaccination process. Obtaining a religious or personal-belief exemption should at least require a visit to the physician’s office, including counseling on the risks posed by remaining unvaccinated; insurance should pay for such visits. States could also require that exemption requests be signed by both parents (if both possess legal decision-making authority). Although such measures wouldn’t change the stance of the most resistant parents, they would eliminate many exemptions sought because of convenience rather than conviction. Finally, lax enforcement of school-entry requirements sends the message that vaccination is merely a bureaucratic requirement, rather than a prerequisite for school attendance and a mechanism for ensuring students’ safety.

One notes that Dr. Diekema’s philosophy is actually not as strict than what was recommended by the Pediatric Infectious Disease Society in 2011. Here is an excerpt from the PIDS position statement regarding personal belief exemption from immunization mandates:

It is recognized that in some states, failure to pass personal belief exemption legislation or regulation could result in public backlash that will erode support for immunization mandates. If legislation or regulation is being considered in this situation, it should contain the following provisions, which are intended to minimize use of exemptions as the “path of least resistance” for children who are behind on immunizations (whereby it would be easier to obtain an exemption than to catch-up the child’s immunizations):

  • The personal belief against immunization must be sincere and firmly held.
  • Before a child is granted an exemption, the parents or guardians must receive state-approved counseling that delineates the personal and public health importance of immunization, the scientific basis for safety of vaccines, and the consequences of exemption for their child as well as other children in the community who are vulnerable to disease and cannot otherwise be protected.
  • Before a child is granted an exemption, the parents or guardians must sign a statement that delineates the basis, strength, and duration of their belief; their understanding of the risks that refusal to immunize has on their child’s health and the health of others (including the potential for serious illness or death); and their acknowledgement that they are making the decision not to vaccinate on behalf of their child.
  • Parents and guardians who claim exemptions should be required to revisit the decision annually with a state-approved counselor and should be required to sign a statement each year to renew the exemption.
  • Children should be barred from school attendance and other group activities if there is an outbreak of a disease that is preventable by a vaccination from which they have been exempted. Parents and guardians who claim exemptions for their children should acknowledge in writing their understanding that this will occur.

The decision not to vaccinate one’s children is every bit as much a medical decision as the decision to vaccinated, and it needs to be made with adequate informed consent. Moreover, although any competent adult has the right to choose or decline any treatment he chooses, society has an interest in protecting children. Contrary to what some seem to believe, parents do not have an unrestricted right to decide medical treatments for their children, particularly if their decisions are very likely to cause harm compared to alternatives. The least that can be asked of parents refusing vaccination for their children is that they listen to a science-based assessment of the potential consequences of that decision.

The real reason antivaccinationists are so opposed to AB 2109 is because they fear informed consent, As I’ve pointed out on more than one occasion, both here and at my not-so-super-secret other blog, the antivaccine version of “informed consent,” like the “alternative” medicine version of informed consent, is a parody of real informed consent. It is, as I have characterized it many times before, in reality misinformed consent, in which the risks of vaccination are hugely exaggerated while the benefits downplayed to the point that any rational person, if she accepted such “risk-benefit” analyses at face value would decide not to vaccinate her child. Unfortunately, the average person doesn’t have the background knowledge and understanding to see through the misinformation at the heart of misinformed consent. They have a hard time knowing that the claims of people like Barbara Loe Fisher that vaccines cause autism, neurodevelopmental disorders, autoimmune diseases, and so many other ills that they attribute to vaccines are without a basis in science, epidemiology, or clinical evidence. A pediatrician can help them do that by providing them with genuine informed, rather than misinformed, consent.

And that’s exactly what the antivaccine movement fears.


Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.