Constitutionality of mandatory vaccinations – Robert F Kennedy Jr. is wrong

If you’re a regular reader of this blog or are just generally aware of current issues regarding vaccinations, you know that Governor Jerry Brown of California signed SB 277 into law. The law removes so-called “personal belief exemptions” for vaccinating children before they enter schools.

Personal belief exemptions were used (and frequently abused) by parents in California to exempt their children from vaccinations using religious beliefs (hardly any mainstream religion is opposed to vaccinations) or the “I don’t like vaccines” belief statement. So many California children were not fully vaccinated, especially when they were clustered in certain areas of the state, lead to several outbreaks of measles, whooping cough, and other infectious diseases.

Thus, the California Senate, led by Senator and Dr. Richard Pan, voted for SB 277, which sailed through the California Senate and Assembly, subsequently becoming law. Its sole purpose was to protect the children of California, the country’s most populous and wealthiest state, from ravages of diseases that were once on the verge of extinction.

Despite the overwhelming support from the legislature and citizens of the state, some groups remain steadfastly opposed. One trope being pushed is doubts about the constitutionality of mandatory vaccinations for children.

Even a group of lawyers wrote a letter to the California legislature, “Statement of Lawyers Opposed to California SB 277,” that tries to deny the constitutionality of mandatory vaccinations for children. The letter concludes:

…we strongly urge you to decline the temptation to tamper with California’s legislative scheme that works to achieve public health objectives while protecting the rights of individuals to make conscientious medical decisions regarding their own health.

Please take the responsible course by rejecting SB 277 and avoiding the legal, educational, and health decision-making chaos that would follow from enactment of this legislation.

The letter is signed by over 150 attorneys but appeared to be written by one Robert F. Kennedy, Jr, a famous attorney with a long history of playing “fast and loose” with the science regarding vaccines. Last month, this blog’s good friend, Dorit Rubinstein Reiss, who spends most of her time (as far as I can tell) writing about legal issues with vaccines, replied to Kennedy’s letter with real science, real constitutional law, and real facts.

Continue reading “Constitutionality of mandatory vaccinations – Robert F Kennedy Jr. is wrong”

Vaccine coverage in USA remains high, but refusal has increased

vaccine coverage

Annually, the US Centers for Disease Control and Prevention publishes reports on vaccine coverage in the country. This year, they produced two reports – one describing vaccine coverage for children 19-35 months old, and a second one discussing vaccination coverage for children entering kindergarten.

Although vaccine coverage remains quite high across most vaccines and hasn’t changed much over the past few years, there is a bit of troubling news. A tiny, but increasing number of children in the country are not getting some or all of their recommended vaccines as a result of parental refusal to vaccinate their children. In fact, the percentage of children under 2 years old who have received none of the recommended vaccines has quadrupled since 2001.

Vaccine coverage – 19-35 months old

The first study by Holly A Hill, MD Ph.D. et al., published in the Morbidity and Mortality Weekly Report, examine vaccine coverage for Advisory Committee on Immunization Practices (ACIP) recommended vaccines in children born in 2015.

For some of the vaccines, the vaccination coverage exceeded 90%:

Unfortunately, for some ACIP-recommended vaccines, the coverage lagged:

There are a few key observations about this data. First, despite the false claims about the MMR vaccine being linked to autism, the vaccine coverage for MMR remains at historically high levels. On the other hand, hepatitis B vaccine coverage, especially at birth, is too low, despite that the fact that these vaccines are important for cancer prevention.

Vaccine coverage by state also showed some interesting information – Massachusetts has the highest vaccination rates for children born in 2015 of all states. The City of New York, considered a “state” for the purposes of this study, had the lowest rate.

However, it is troubling that, even though the proportion of children who received no vaccines by age 24 months, it has increased from 0.3% for children born in 2001 to 0.9% for children born in 2011 to 1.3% for children born in 2015. This works out to be over 100,000 children born in 2015 who aren’t vaccinated against 14 dangerous and deadly diseases. This is worrisome.

Although I do not want to give credit to the anti-vaccine religion for causing this troubling increase in vaccine refusal. The internet is filled with ignorant and scientifically inaccurate information about vaccines. Quora, where individuals can ask questions about almost anything, is filled with individuals asking questions about vaccines in good faith. Although 95% of the answers are scientifically and medically accurate, there are many individuals who use misinformation, ignorance, and outright lies to scare people about vaccines.

Eventually, this can lead to the point, where the overall vaccine coverage will drop below the level to maintain the herd effect. At that point, there are insufficient numbers of immunized people to block the spread of an outbreak or epidemic of these vaccine-preventable diseases.

On the other hand, the study points out that part of the lack of vaccination may be a result of an ongoing issue with the USA – the lack of universal health insurance, especially for the poor. This study showed that 17.2% of unvaccinated children were uninsured compared to 2.8% of all children. Looking at the data from another direction, over 7% of uninsured children were unvaccinated compared to only 1.0% of children on Medicaid and 0.8% of children on private health insurance.

This is one of the great moral failings of the country. However, there really are no reasons why any child in the USA is denied vaccines. The Vaccines for Children Program provides free vaccines for all children in the USA who otherwise have no insurance coverage. The program has saved hundreds of thousands of lives over the past 20 years.

Vaccine coverage – kindergartners

A second report, by Jenelle L Mellerson et al. and published in the Morbidity and Mortality Weekly Report, examined vaccine coverage for children entering kindergarten in 2017. The good news is that, despite somewhat lower vaccination rates in states like DC, Idaho, and Colorado, the overall vaccine coverage for the major vaccines is well over 90% for kindergartners.

The researchers found that the exemption rate was low, about 2.2%. Unfortunately, it was the third consecutive school year that a slight increase noted. The 2.2% exemption rate during the 2017-18 school year was up from 2.0% in 2016-17, and 1.9% in 2015-16.

The study does not provide a breakdown between medical (where there is a valid medical reason to not vaccinate a child with one or more vaccines) and non-medical exemptions. The non-medical exemptions, often called “personal belief” exemptions are simply refusing to vaccinate a child because of a variety of reasons – religious (no religion is opposed to vaccines) or because “we don’t like vaccines.” Most exemptions are of the non-medical variety.

Only a few states disallow these personal belief exemptions – California, Mississippi, and West Virginia. Unsurprisingly, California and Mississippi have the lowest non-medical exemption rates in the USA, at less than 0.1%. Unfortunately, California has an issue where unethical physicians are giving out (or even selling) non-medical exemptions for parents who want to put their children in danger of vaccine-preventable diseases.

Summary

These two studies show us two dangerous trends – first, too many very young children are going unvaccinated because of parental ignorance or lack of health insurance. And second, too many parents are putting their children at risk of vaccine-preventable diseases by requesting non-medical exemptions.

However, despite the pseudoscientific lies of the hysterical anti-vaccine religion, nearly 95% of children are vaccinated before they enter school. Unlike the anti-vaccine zealots, who seem to dismiss a few thousand cases of cancer or deaths from measles as unimportant or trivial, most of us on the pro-science side of vaccines want all children protected from dangerous and deadly diseases. That’s why we fight to make sure every single child is vaccinated.

Why aren’t you making sure that your children are protected from vaccine-preventable diseases?

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Medical exemption abuse – hurting California’s vaccine uptake

Medical exemption abuse

Since the enactment of California’s SB277, which prevents parents from using religious or personal beliefs to excuse their children from vaccinations, has lead to much higher vaccine uptake rates in California schools. The law still allows medical exemptions, which are medically-related reasons for not vaccinating, such as allergies to ingredients in the vaccine. Unfortunately, this had led to medical exemption abuse in many schools in California.

In California, medical exemptions require a form signed by their doctor stating a valid medical reason for any child to not receive vaccines. Generally, less than 2-3% of children would have medical reasons to not be vaccinated. Moreover, most of these children would only be exempt from a few vaccines, not all of them. Continue reading “Medical exemption abuse – hurting California’s vaccine uptake”

Vaccine legislation in the USA – a state by state analysis

vaccine legislation

One of the most successful pieces of vaccine legislation in recent years has been SB277 in California, which eliminated personal belief exemptions (PBE), that allowed a parent to exclude a child from immunization requirements for school based on the parent’s personal beliefs, including religious objections.  These PBEs had been used and abused by anti-vaccine parents to exempt their school-aged children from most, if not all, vaccines.

Other than California, only West Virginia and Mississippi have such strict prohibitions on these PBEs that they are effectively not allowed as a method to refuse vaccines before a child enters school. But many other states are considering vaccine legislation that could improve vaccine uptake. Unfortunately, there are also states on the other side of the equation that are considering laws that reduce restrictions on personal belief exemptions.

The National Vaccine Information Center (NVIC), which seems to conflate “information” with misinformation about vaccines, claims that there are 134 vaccine bills being considered in 35 states. I wish!

I thought we would could take a look at current vaccine legislation being considered by various states that could potentially increase vaccine uptake in those states. Then we’ll take a look at those states pushing legislation that might decrease vaccine uptake. This should provide real information about what’s going on with these laws, instead of the alternative facts from the vaccine deniers at NVIC.

Continue reading “Vaccine legislation in the USA – a state by state analysis”

California SB277 expected to drop vaccine preventable disease rates

California sb277

California SB277 makes immunization mandatory for children attending schools in the state by removing personal belief exemptions for vaccination. These personal belief exemptions were abused by parents in pockets of California, causing immunization rates in some communities to fall precipitously. California SB277 should correct that abuse. The new vaccine requirements should increase the vaccination rate, as long as someone doesn’t find some loophole to abuse the system, because anti-vaccine parents tend to be a resourceful group.

California joined two other states, West Virginia and Mississippi, with the most stringent requirements for vaccination for children before they can enter school. West Virginia State Law does not allow for non-medical exemptions to immunization requirements. Mississippi only allows medical exemptions (as does California), which allows parents to request an exemption for their child if there is a medical condition that contraindicates a vaccine. All three states require physician certification of medical exemptions.

Interestingly, West Virginia legislators strengthened vaccination laws in 2015 by extending vaccination requirements to preschoolers. And it created the position of state Immunization Officer, who is responsible for ruling on the validity of requested medical exemptions in an unbiased manner. Maybe California could implement such a position.

The results of these strict enforcement of exemptions are significant reduction in incidence of diseases. For example, Mississippi has not had a case of measles since 1992, and West Virginia since 2009. On the other hand, there was a relatively large measles outbreak at Disneyland in 2015, where 134 individuals (mostly Californians, though residents of six other states and two countries) were infected with the disease.

The drop in disease rates in California will be much more apparent in California, which has 9 million children in school, compared to 737 thousand in Mississippi and 382 thousand in West Virginia. Diseases like chickenpox and measles are highly infectious, so high immunization rates should block any spread of the disease

California SB277 became effective on July 1, 2016, so this is the first school year where the mandatory vaccine requirements were in place. Unfortunately, because of that prior abuse of personal belief exemptions in California, there are still communities at risk for vaccine preventable diseases.

A measles outbreak in the Orthodox Jewish community in parts of Los Angeles struck 20 individuals. And when county health officers started tracking down the 2000 people who were in contact with measles patients, they found that over 10% of them were not vaccinated.

A recent mumps outbreak in Los Angeles has stricken seven adult males who lacked vaccination to the disease (usually from the MMR vaccine). And last month, there was an outbreak of mumps amongst college students in Southern California. Hopefully, as we increase the vaccine uptake in California, the risk of these type of outbreaks will become lower and lower.

Unfortunately, there is a loophole (I told you) in the California SB277 – the medical exemption only requires a letter from a physician, and it’s not further scrutinized as is done in West Virginia. And because there are numerous anti-vaccine doctors who ignore real science for their beliefs, there appears to be a growing cottage industry forming to make medical exemptions somewhat easily available.

According to the garrulous Orac, it seems that medical exemptions are for sale. Orac mentions a Dr. Tara Zandvliet, who charges $120 per child for medical exemptions for vaccines. She describes what constitutes a valid, in her opinion, medical exemption for vaccines:

Hyper immune conditions
Including, but not limited to:

  • Asthma
  • Allergies to food, bee stings, medicines that include hives/swelling/wheezing (hay fever does not count)
  • Eczema
  • Hives

Autoimmune Conditions
Including, but not limited to:

  • Celiac
  • Crohn’s
  • Ulcerative Colitis
  • Lupus
  • Sjogrens
  • Scleroderma
  • Mixed connective tissue
  • Hashimoto or Graves thyroid (not regular low thyroid)
  • Psoriasis
  • Vitiligo
  • Vasculitis
  • Antiphospholipid antibody
  • Multiple Sclerosis
  • Rheumatoid arthritis (not old age or overuse arthritis)
  • Wegeners
  • Type 1 diabetes (child type)
  • Eosinophilic esophagitis
  • Documented autoimmune only – not suspected autoimmune such as fibromyalgia, chronic fatigue, Lyme or endometriosis. Those will not qualify.

Immune Cancers
Including, but not limited to:

  • Lymphoma
  • Leukemia
  • Multiple myeloma

Immune deficiencies
Including, but not limited to:

  • SCID
  • Agammaglobulinemia
  • Documented diseases only. Not “getting sick a lot”.

Genetic conditions associated with worse outcomes

  • Studies are still pending, but include MTHFR, Some HLA subtypes.

Vaccine reactions

  • Vaccine reactions must be related to the vaccine within about a week, and must be immediate and not caused by anything else. These reactions include but are not limited to:
  • Seizure
  • Anaphylaxis
  • Leg swelling causing hospitalization
  • Difficulty breathing
  • Encephalitis, including high-pitched cry and developmental regression
  • Coma
  • Severe lethargy
  • Fevers over 103
  • Bad reactions do NOT include fevers under 103, sore leg, cranky, getting sick a lot after, getting asthma after, having allergies after vaccination.

This is a ridiculous list. Children with type 1 diabetes, for example, are more susceptible to and more at risk of complications from vaccine preventable diseases. If Dr. Zandvliet had any idea about diabetes, she would be strongly recommending vaccines for those children. Ironically, the only treatment for type 1 diabetes is 3-4 times daily injections of insulin, whose package insert (pdf) would make any anti-vaxxer faint – vaccines should be a walk in the park for any child with diabetes. And should be  required.

Dr. Zandvliet also states that MTHFR gene mutation is a risk factor for vaccines. But that’s simply not true, and no reliable source says that this gene mutation is a serious contraindication for vaccines.

Furthermore, her list of vaccine reactions actually may or may not be related to vaccines. The whole list is dependent upon parental memory and post hoc logical fallacies.

Finally, as Orac points out, the actual list of real contraindications for vaccines is rather limited – severe allergic reaction to the vaccine or its components, which will be obvious to anyone, is the major one. But I suppose, to get the vaccine medical exemption, people will try to make that claim. And because California relies upon the word of the physician rather than an independent, unbiased party, like West Virginia’s Immunization officer, there will be no way to dismiss this problem.

But there is some good news. Late last year, the California Medical Board started actions to pull the license of Dr. Robert Sears, a notorious anti-vaccine physician, who wrote a medical exemption for a 2 year old child. In a post in CityWatch, Bob Gelfand wrote:

The charges against Sears cannot help but create a stultifying effect on pediatricians who have been merchandising themselves as anti-vaccine practitioners, and on those who have been considering doing so. They are all thinking things through very carefully at the moment. The upside to writing slightly spurious vaccine exemptions is to build one’s medical practice and to gain the gratitude of anti-vaccine parents. The downside is the possible loss of one’s career.

By the way, continuing a narrative that bothers me about the anti-vaccine movement, it feels like only white privileged types are going to be able to get these “for sale” medical exemptions. Dr. Sears practices in a swanky part of Southern California, and caters to wealthy parents. Of course, Dr. Zandvliet charges $120 for her “services” in providing medical exemptions. I’ve seen numerous other “ads” from physicians in the expensive areas of California saying that they’ll consider writing medical exemptions for children.

The problem with this industry is that it has a negative impact on the California SB277 – the law may not be as effective as we want, although I’ve got a feeling that a lot of people who used personal belief exemptions are not going to be bothered by trying to find a pediatrician to write an exemption, once their own physician says, “NO!”

As long as California SB277 increases the uptake rate for childhood vaccines, despite the exemption industry, the overall effect should be strongly positive. But we all await data from California on the exemption rate and vaccination rate – as I always say, it’s the evidence that matters, and hopefully we’ll get some good evidence soon.

 

Attacking SB277 with another lawsuit –Torrey-Love v. State of California

On 21 November 2016, a new lawsuit attacking SB277, the state’s statute removing the personal belief exemption from immunization requirements, was filed with a federal district court in Riverside (Central District of California, Eastern Division), assigned to Judge Dolly M. Dee. The complaint, like previous lawsuits, faces serious hurdles.

Continue reading “Attacking SB277 with another lawsuit –Torrey-Love v. State of California”

California SB277 lawsuit – state’s demurrer to Buck v Smith sustained

SB277 lawsuit

In 2015, California enacted into law a measure, SB277, that eliminated all non-medical vaccine exemptions to required school-entry vaccines. There were a number of factions in opposition to this law.  One faction, “Revolt, Revoke, Restore”, hired an attorney, T. Matthew Phillips, who eventually filed an SB277 lawsuit to stop the implementation of law. (Previous coverage of litigation  filed by Phillips can be found here.)

This SB277 lawsuit is called Buck v. Smith, or Buck v. California. Tamara Buck is the first of the seven plaintiffs; Karen Smith is the Director of the California Department of Public Health. The suit was first filed in July, 2016, and has been amended three times. In response, the state filed a demurrer. A demurrer is a written response to a complaint filed in a lawsuit which, in effect, pleads for dismissal on the grounds that even if the facts alleged in the complaint were true, there is no legal basis for a lawsuit. In this case, Basically, the court is saying “you have to show it’s unconstitutional to mandate vaccines for school before we ask if vaccines cause harm.”

On 21 October 2016, California superior court judge Gregory Alarcon in LA County sustained – accepted – the demurrer of the state and dismissed the SB277 lawsuit filed by Tamara Buck and seven other plaintiffs without leave to amend. What this means is that even after being amended three times, the complaint at the basis of the lawsuit had been found not to make a valid legal claim, and/or not to have enough facts to support a valid legal claim, or “cause of action.” Unless the trial court’s ruling is overturned on appeal, the Buck lawsuit is now dismissed and will not go forward.

There were two main reasons the complaint failed to meet the standard. First, some of the claims simply go against established jurisprudence; this is a problem any challenge to SB277 will face. Second, in this case, the complaint was not well written or argued. Continue reading “California SB277 lawsuit – state’s demurrer to Buck v Smith sustained”

California SB277 lawsuit analysis – anything there?

California SB277 lawsuit analysis

California enacted SB277 on 1 July 2015. This new law removed the “personal belief exemption” (PBE) to vaccines required for school entry.  The law went into effect 1 July 2016.  One group filed a suit against SB277 in California courts in May; I discussed that complaint in previous article. This California SB277 lawsuit analysis is about new litigation against SB277 filed in the state. (Note, there is an update to this case, California SB277 vaccination law – litigation update 1.”)

This second lawsuit, with a different group of plaintiffs, including Ana Whitlow, was filed in a federal district court on 1 July 2016. The suit was brought by several individual plaintiffs and a number of organizational plaintiffs. It contained both state and federal claims, claims on constitutional grounds, and claims that focused on implementation of the act.

As the complaint states, California has had a personal belief exemption from its school immunization requirements since at least the 1960s. The complaint does not note that between 1996-2010, California’s exemption rate increased 380%, from 0.5-2.3%.  The increase continued until at least 2014.

While the number never went over 3%, the exemption rate was not evenly distributed: some areas and some schools had much higher rates of PBEs than others, making them hot spots for outbreaks. In 2010, California experienced a dramatic outbreak of pertussis in which ten babies died. Pertussis has continued to circulate at a higher rate than in the past.  While the pertussis outbreak was partly the fault of a less effective vaccine, studies repeatedly found that areas with high rates of exemptions were more vulnerable to outbreaks.

In 2014, California had the highest rate of measles since 1994, and the famous 2015 measles outbreak caused even higher numbers. This background led the California Legislature to reconsider its immunization policy – already tightened once, in 2012 – and to decide to remove the personal belief exemption.

Understandably, those influenced by anti-vaccine claims were distressed by the new legislation. These parents evidently feel trapped, caught between a reluctance to vaccinate their children and their desire for their children to access educational opportunities, now closed to them by the new law’s provisions. Hence the lawsuit.

This complaint does not suffer from the lack of professionalism and the severe problems of the previous claim, filed by a different attorney in state court.

Nevertheless, while you can never be certain how a court will decide, my best assessment is that the plaintiffs’ constitutional claims have very low chances of success. While some of the statutory issues call for interpretation, they won’t lead to the law being struck down. And several of their implementation claims suffer from serious procedural problems.

Note that the discussion here refers both to the content of the complaint itself and the content of the memorandum submitted in support of the Temporary Restraining Order – both together present the plaintiffs’ arguments.

The complaint also tries to reframe the narrative drawing on anti-vaccine factual claims that are either misleading or downright incorrect. My focus in this post is on the legal claims, but I will touch on a few of the counter-factual assertions. Continue reading “California SB277 lawsuit analysis – anything there?”

Update: Gov. Brown signs California vaccine exemption bill

The California vaccine exemption bill – SB 277, which essentially eliminates all vaccine personal belief exemptions for children to be vaccines prior to attending schools in the state – was signed into law today by Governor Jerry Brown (D).

The SB 277 vaccine exemption bill was sponsored by California Senator Richard Pan MD and by Ben Allen, of Santa Monica. The bill was introduced after a outbreak of measles in December at Disneyland sickened 136 Californians. It passed quickly through both houses of the California Legislature.

The law applies to students attending any public or private school in the state, so parents who choose not to vaccinate children for non-medical reasons would need to make other arrangements for their child’s education. Now, only valid medical exemptions, such as known allergies and other medical conditions, approved by a physician, will be allowed an exemption to vaccination.

Governor Brown also reiterated, while signing the bill, that “while requiring that school children be vaccinated, the law explicitly provides an exception when a physician believes that circumstances – in the judgment and sound discretion of the physician – so warrant.”

There is some evidence that the medical exemption has been abused by parents who do not want their children vaccinated with cooperation of like minded physicians. This does worry me, since there are pediatricians who “advertise” their services in signing these forms.

Notwithstanding my concern, this makes California one of the three toughest states for vaccinations, along with Mississippi and West Virginia. And that is good news indeed.

 

Update: SB 277 vaccine bill sent to Gov. Brown

he California SB 277 vaccine bill, which essentially eliminates all vaccine personal belief exemptions for children in schools in the state, has passed it’s last hurdle in the California legislature and has been sent to Governor Jerry Brown for his signature.

The SB 277 vaccine bill was sponsored by California Senator Richard Pan MD and by Ben Allen, of Santa Monica. The bill was introduced after a outbreak of measles in December at Disneyland sickened 136 Californians, and it passed 25-10 after the two senators agreed earlier to compromises aimed at easing its passage.

This makes California one of the three toughest states for vaccinations, along with Mississippi and West Virginia. Now, only valid medical exemptions, such as known allergies and other medical conditions, will be allowed an exemption to vaccination. Continue reading “Update: SB 277 vaccine bill sent to Gov. Brown”