Non-Medical Vaccine Exemptions: Balancing Parental Rights and Public Health

U.S. Religious and Philosophical Vaccine Exemptions 

Philosophical and religious vaccine exemptions have been a hot topic lately with California's AB 2109 Bill which would require parents who wish to opt out of vaccination obtain an approved healthcare providers' signature that the parents have been advised of the risks of not vaccinating.  And Washington State's recent passing of the same type of bill has anti-vaxx groups in a collective apoplexy.  New Jersey is also discussing tightening their religious exemptions and a new bill S1759 has been submitted to the state Senate for a vote.  New Jersey has no philosophical exemption so its religious exemption has been easily used for parents to opt out of vaccines.

I like others have a problem with just religious exemptions for the reason that there are no recognised religious organisations that oppose vaccines and they also exclude secular beliefs.  In fact, there is no constitutional right or protection requiring religious exemptions to be provided.  There are no constitutional protections from compulsory vaccination for philosophical reasons either in spite of vapid assertions to the contrary.

An Equal Protection challenge to vaccination regulations was denied in Zucht v. King as the U.S. Supreme Court ruled that vaccination laws do not discriminate against schoolchildren to the exclusion of others similarly situated (i.e., children not enrolled in school). (221)  In the case of Adams v. Milwaukee, Justice Brandeis reaffirmed Jacobson's holding that states may delegate the power to order vaccinations to local municipalities, and that broad discretion must be granted in the application and enforcement of the resulting public health regulations. (222)  In Prince v. Massachusetts, the Supreme Court held that the First Amendment's Free Exercise Clause does not allow for the right to expose the community or one's children to harm from disease. (223)  An Arkansas court later affirmed that school vaccination requirements do not deprive individuals of liberty and property interests without due process of the law. (224) Moreover, even where a parent objects to compulsory vaccination, a child does not have an absolute right to enter school to receive an education. (225)  Clearly then, the rights of individuals to be free from unwanted government interference in the form of compulsory vaccinations have been severely limited by the courts where public health is at stake.

But what about the constitutionality of compulsory vaccinations where no exemptions at all are provided--i.e., neither for philosophical nor religious reasons?  Again, the judiciary has held that individual rights may be restricted in the name of the public welfare without violating the Constitution.

States that do offer religious exemptions place themselves in a more precarious position legally.

Some state courts have held that parents must be members of a "nationally recognized and established church or religious denomination" in order to claim an exemption, (229) but others have found that similar regulations violate the Equal Protection Clause of the Constitution by giving preference to certain religions over other. (230)  Moreover, some courts have gone as far as to say that providing any religious exemption violates the Equal Protection Clause because it "discriminate[s] against the great majority of children whose parents have no such religious convictions." (231)

As it stands now, 48 U.S. states allow religious exemptions and 20 allow philosophical exemptions.   Some retrospective analyses of Arkansas, which allowed philosophical vaccine exemptions beginning the 2003-2004 school year have revealed a startling trend which has been observed in other states as well.

Total exemptions numbered 529 in Year 1; 651 in Year 2; 764 in Year 3; and 1145 in Year 4. Between Years 1 and 2, the total number of exemptions granted rose by 23%. After philosophical exemptions were allowed in Year 3, total exemptions granted increased by 17% over the previous year, and by 50% more from Year 3 to 4 (Figure 1).

In Year 3, nonmedical exemptions (including religious and philosophical options) were 1.37-fold higher than nonmedical exemptions in Year 2 (139 versus 64) and 1.67-fold higher than nonmedical exemptions in Year 1 (110 versus 64), when religion was the only option for nonmedical exemptions. In Year 4, nonmedical exemptions (62) were 2.12-fold higher than in Year 2 and 2.58-fold higher than in Year 1. In Years 3 and 4, the majority of the nonmedical exemptions (58% [403 of 700] and 67% [721 of 1083], respectively) were based on philosophical rather than religious (297 and 362, respectively) reasons.

Medical exemptions constituted 21% of all exemptions in both Years 1 and 2. However, with the introduction of philosophical exemptions, the absolute number of medical exemptions dropped by more than half (from 139 in Year 2 to 64 in Year 3 and 62 in Year 4). Thus, medical exemptions accounted for only 8% of Year 3 and 5% of Year 4 exemptions.

Emphasis added.  This is a concerning statistic as it would appear "vaccine-friendly" physicians may have been issuing medical exemptions where they weren't medically-indicated.  This seems to be an unintended finding that should be addressed by public health officials in concert with state medical regulators.

A more recent study conducted by Safi et al. (2012) and includes additional years of data sets has confirmed the previous finding by Thompson et al. (2007).  However Safi et al. included some additional statistics which reveal a number of interesting findings:

Analysis of exemptions by vaccine type revealed that in the 2009 –2010 school year, 70.8% (1922) of exemptions were requested for all vaccines, 9.2% (249) were requested for two or more vaccines, and 20% (543) were requested for a single vaccine. A similar pattern also was seen for previous years. More than 92.8% of single-vaccine exemptions requested were for the measles, mumps, and rubella (MMR) vaccine and 4.6% were for both hepatitis B and varicella. Of 504 single MMR vaccine exemptions, 436 (86.5%) were requested for college students. MMR vaccine is the only required immunization for college enrollment in Arkansas.

The prevalence of children in home schools, not involved in any public school activities, who are undervaccinated is not known, nor of foreign children residing in Arkansas. Even though vaccine exemption–associated outbreaks have not yet been identified during this study period (2001–2010), the increasing trend of exemption in specific colleges in Arkansas raises particular concern because of previous links of infected (symptomatic or asymptomatic) exempted students with mumps and measles outbreaks. ^{[4], [9], [10], [11] and [12]}

Private schools are not included in the collection of these statistics and given the date of the incident, Safi et al. were unaware of this recent Arkansas boarding school measles outbreak. It has also become well-known that Waldorf Schools have become hotbeds for high vaccine exemptions and thus pertussis and measles outbreaks.  The MMR triple jab had the highest number of exemptions for school age and university students which appears to be a shameful repercussion of Wakefield et al.'s fraudulent and retracted Lancet paper even over a decade after the fact.

The recent moves by various states to tighten the ability to acquire non-medical vaccine exemptions are laudable but rather futile efforts that are easily overcome by determined anti-vaxx groups whether it be through convincing credulous politicians to ignore experts in Vermont, lobbying California to include naturopaths as an approved healthcare practitioner to provide vaccine exemption counselling for AB2109 (which is as good as a rubber stamp) and challenging states over the constitutionality of tightening existing religious exemptions such as New Jersey.  Parents who hold these beliefs will not be swayed by a brief meeting with a "healthcare practitioner" who will be undoubtedly shopped for in order to provide a signature needed to be on their way as quickly as possible.  These measures will not increase vaccination rates in any appreciable way.  Political-correctness and pseudo-scientific grandstanding have no business in public health policy, only solid scientific evidence does.

What can States do About Balancing Parental Rights with Public Health?

It's rather easy, in theory at least but would provide parents and public health with the fairest way to balance their respective interests bearing in mind that public health policies are measures to create benefit and protection for the majority of a population.

• Eliminate all religious exemptions and have just philosophical exemptions

States would eliminate, or more realistically reduce the number of legal challenges that can be made by simply providing philosophical exemptions.  There are secular reasons for seeking vaccine exemptions and no religious belief should be deemed superior to another in the matter of exemption from vaccines.

• Enact philosophical exemptions for particular vaccines and all vaccines

Track specific vaccine exemptions rather than make them "all or nothing".  States such as California and Colorado are already doing this (more or less).  This provides more accurate data regarding vaccine uptake and provides schools requisite information to manage outbreaks more fairly and effectively.  As it stands now, any student with a vaccine exemption is required to stay home from school in the event of an outbreak which can mean several weeks out during the school year.  This may be rightfully deserved according to some but ultimately, the children suffer for the parents' actions and tutors are provided by schools at taxpayer expense if a certain number of consecutive days are missed.

Allowing selective exemptions would prevent unnecessary exclusions from school.  For example, a student with an exemption for hepatitis b would be allowed to remain in school in the event of a measles outbreak.  Parents who have an "all vaccines" exemption on file for their children would of course be required to stay home in the event of an outbreak of any VPD.  Outbreak control measures may include requiring students stay out of school for an outbreak of a VPD anywhere in the school district rather than just at the school of enrolment given disease transmission dynamics and incubation periods.

• Standardise criteria for state vaccine mandates

Rigorous criteria for determining which vaccine antigens should be mandated by a state is currently being used in the State of Washington as reported by Lantos et al. (2010):

Washington became one of the first states to develop explicit criteria when its Board of Health convened an Immunization Advisory Committee in 2005 to provide recommendations for how to determine whether a new antigen should be part of the State's required immunizations for entry into school or child care.⁵¹ The Washington State Board of Health realized, in part, that rigorous criteria were needed as it became clear that several vaccines in development were likely to be recommended for children and adolescents and proponents were likely to propose mandates. Indeed, in 2005, the quadrivalent conjugate meningococcal vaccine was licensed, followed by the first human papillomavirus (HPV) vaccine and the first rotavirus vaccine in 2006.

Washington State's 9 criteria are grouped into 3 categories: vaccine effectiveness, public health disease burden, and implementation.⁵² These criteria are meant to sufficiently address the different layers involved in public policy decisions. There are 4 criteria of vaccine-effectiveness; (1) the vaccine containing the antigen has been recommended by Advisory Committee on Immunization Practices; (2) its effectiveness has been established by immunogenicity; (3) it is cost-effective from a society perspective; and (4) it is safe with an acceptable level of adverse effects. The 2 public health burden criteria are (1) that the vaccine containing the antigen prevents a disease that has significant morbidity and/or mortality; and (2) that vaccinating children and adolescents reduces transmission of the disease. The last 3 criteria reflect implementation of the vaccination program: the vaccine must be acceptable to the medical community and the public, the administrative burdens of delivering the vaccine must be acceptable, and the burden of compliance for vaccination is considered reasonable for the parent.

The process for evaluating an antigen for inclusion in school mandates in Washington State involves 3 steps. The Board of Health first does a preliminary review of the antigen of interest to determine whether there is enough information about the antigen for the 9 criteria to be used. Second, a group of representatives from public health, primary care, epidemiology, ethics, and others (such as parents and school administrators) is appointed by the Board. Finally, these appointees review the antigen in question using the 9 criteria and provide a recommendation to the Board. Although these criteria and the process in which an antigen is evaluated against them require some clarifications, they offer a deliberate and informed approach to determining which vaccines should, and should not, be required for school entry.⁵¹ Washington State's Board of Health used these criteria to include the meningococcal vaccine as part of the require immunizations for school entry in 2005. Washington State does not include the HPV or rotavirus vaccines in its school immunization laws.

Other states have come to different decisions. As of June 2009, school mandates exist in 18 states for the meningococcal vaccine,⁵³ and in 2 states (District of Columbia and Virginia) for the HPV vaccine.⁵⁴ No state has a school mandate for the rotavirus vaccines.

Such a process will ensure that an evidence-based approach will be implemented to decide which vaccines should be part of school vaccine mandates.  Such an evidence-based and transparent method may also serve to address some parental fears about vaccinating by addressing individual state's VPD epidemiology.

• Require private and parochial schools to adopt and record the same mandatory vaccines and/or exemptions as public schools

The State of West Virginia (which only has a medical vaccine exemption) requires this already.  Many or most U.S. private and parochial schools do not require vaccines for school entry and/or attract anti-vaxx parents with easy opt outs for vaccines.  Some of these schools have exemption rates of over 80%, particularly Waldorf Schools.  Since schools are the primary sources of disease transmission, there is simply no justification for allowing private and/or parochial schools different standards for vaccine requirements.

• Limit the number of philosophical vaccine exemptions

Given the alarming numbers of philosophical and religious exemptions that some state school districts and counties are issuing, it has become necessary to cap the number of non-medical exemptions for any given school.  These exemptions are based upon pseudo-scientific information that is easily available to credulous parents concerned with vaccine adverse effects; there is no reason to continue to entertain these fallacious beliefs and extraordinary senses of entitlement in the form of high numbers of vaccine exemptions that erode herd immunity.

Herd immunity assumes the equal distribution of susceptible people; this very crucial aspect of herd immunity is compromised by high numbers of non-vaccinated geographically-clustered, particularly at a school level.  In order to achieve herd immunity threshold, the minimum percentage of people vaccinated for a disease is based upon vaccine effectiveness, disease transmissibility or infectiousness (for example measles is far more transmissible than hepatitis b so a higher percentage of people need to be vaccinated for the former than the latter), population mixing and vaccine failure.  For example, measles vaccination uptake to achieve herd immunity threshold is estimated to be 90-93% due to the extremely high infectiousness of measles and an estimated 5% primary vaccine failure rate.  And again, that is also assuming an equal distribution of susceptible people in a large population.

There are several school districts and/or counties throughout the U.S. that do not reach this threshold, California being a glaring example.  Using measles again as an example of how to cap philosophical exemptions and hypothetical school A with a student population of 1000 students, the upper limit for the number of unvaccinated children must be lower than 7% to account for clustering of susceptible children, let's arbitrarily say 4% which would be 40 students.  Medical exemptions would be provided first, next allow selective vaccinators in order of one and two vaccines refused and if the 4% exemption for measles vaccination hasn't been met then full vaccine exemptions can be provided for the remainder.  A higher number of exemptions could be allowed for say, hepatitis a and b but a lower number for pertussis.  Such a system would "reward" those who have their children vaccinated the most according to state mandates and encourage at least some vaccination.

Implementation of philosophical exemptions could be done by lottery and monitoring of medical exemptions which would have the potential for abuse should be considered.

• Requirement of an informed consent statement for philosophical exemptions

This is in line with what Washington State has already enacted and what California may be next in doing.  With all due respect to these state's public health officials, higher standards of informed consent with greater efficiency need to be implemented.  Instead of requiring a signature from a "healthcare provider" which can mean naturopaths who are notoriously anti-vaccine or one of Dr. Bob Sears "vaccine-friendly" doctors, hold public seminars for potential philosophical exemption-seekers with qualified professional scientists and/or physicians.  Said professional scientists and/or physicians would be very familiar with anti-vaccine arguments, websites and purveyors of vaccine misinformation in order to more adequately address parental concerns and objections to vaccines.  A single speaker could reach hundreds of parents at a time taking the burden off of individual providers, disseminate much more relevant information, while dismantling anti-vaccine myths and provide statements of informed consent at the end of the seminar.

Some may ask why even bother to have philosophical exemptions but I feel as though our society can withstand a certain amount of individual freedoms without infringing on the safety of others.  However, there are some areas of the U.S. that appear to have a disproportionate number of parents who feel as though their own entitlements supersede those of the community to the point that once-eliminated or lowly endemic vaccine-preventable diseases are creating outbreaks with their direct actions.

Although philosophical and religious vaccine exemptions are a politically-charged issue, medical science must be the basis for public health decisions and not emotive, politically-motivated ones.  Contrary to popular belief, we do not have a constitutional right to philosophical nor religious vaccine exemptions; the courts have been clear on that.  Such exemptions are a privilege and unfortunately, a privilege which is being abused to the point of endangering society and must be adapted to protect the larger society while maintaining some ability for individual freedoms.

Buy this Book Before Big Bad Pharma has it Pulled off the market

Here's Ben Goldacre holding the first copy of his new book "Bad Pharma" (I will hold mine tonight, squee):

Those of you who have followed the story of "Bad Science" will know that the first edition was missing a chapter, because the dangerous quack discussed in that story was suing Dr. Goldacre. The chapter appeared online after the law suit and was added to the second edition of the book.

Now Ben might be facetious when he asks his readers to buy the book before it gets pulled, but it is not an unrealistic worry given his previous experience and industry practise. What can you expect? Luckily, Ben Goldacre generously shares the whole Introduction here:

So to be clear, this whole book is about meticulously defending every assertion in the paragraph that follows.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies doesn’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in its life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most part, they have failed; so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.

In short - the book that everyone should read and that could be the beginning of something amazingly beautiful: evidence-based medicine.

For those of you in the US - ask a European friend to send you the book or bridge the time until January 2013 with reading Ben's excellent blog.

NOTE: I linked to Amazon.co.uk and Amazon.com up there, but if you have a chance, support your local book store and buy it there.

Edited to add: David Colquhoun, the excellent pharmacologist and skeptic has weighed in. I have changed the book link to a store which pays taxes in the UK following his example.

Speaking of Potential Outbreaks - New SARS-Like Virus Detected in UK

The British Health Protection Agency warns today:

The Health Protection Agency (HPA) can confirm the diagnosis of one laboratory confirmed case of severe respiratory illness associated with a new type of coronavirus. The patient, who is from the Middle East and recently arrived in the UK, is receiving intensive care treatment in a London hospital.


In recent months, this new human coronavirus was also identified in a patient with acute respiratory illness in Saudi Arabia, who subsequently died.

This comes after the death of a man from the same virus in Saudi Arabia. With the Hajj starting in a month from now, the risk of an outbreak is very real and health personnel is being advised how to deal with patients with respiratory illnesses accordingly.

Update: what the WHO says.

Holy Bear Turd - Get in Line, Epis...

Mountain Laurel Waldorf School stands good chances of doubling the US' measles cases:

The school has just over 130 students enrolled. .../... According to NYS Health Commissioner Shah, nearly half of the students have not been immunized for measles.

Wow.

Students and staff who have not been immunized have been excluded from the school until the danger of infection passes. While measles immunization is a requirement in New York State, private schools have the authority to make exceptions. The concern in New Paltz is for anyone who may have attended or visited the school after September 10.

Indeed.

Update: This morning the actual numbers appeared:

Eighty of the private grade school's 145 students were sent home, said Ulster County Health Commissioner Carol Smith. Since the weekend, 27 children have been vaccinated and allowed to return to school, Smith said Monday.

I found this statement of one of the parents of the vaccinated children interesting:

One Mountain Laurel parent, John Ascione, has two children attending the school; both have been vaccinated. He characterized opposition to vaccination as a result of skepticism by some parents of children attending an alternative-minded school to what he called the "corporate influence" in such institutions as the Food and Drug Administration and the CDC.

I wonder whether he and the other parents are fully aware of the Steiner philosophy and that it is not just a squishy, nacheral, crunchy alternative to teh ebil FDA/CDC run world.

In Yet Other News, Bears Still Crap in the Woods

and measles prefer the crunchy (unvaccinated) Waldorf/Steiner pupils, especially those who travel. The Dutchess County Department of Health wrote Friday:

The Dutchess County Department of Health announced today a confirmed case of measles in a student at the Mountain Laurel Waldorf School in New Paltz, NY.  Anyone who has visited this school since September 10th or has had any contact with anyone from this school should immediately make sure that they are up to date with their measles vaccinations.  All medical practices and laboratories in the area should be on high alert that there may be a number of other children and families who have been exposed and could be communicable.

We have learned that a number of students at this school were not vaccinated and may become ill and put other children and families at risk for contracting measles.

Mountain Laurel Waldorf School has no alert on their website, but if the student attended the school for several days before being diagnosed, it may be too late anyway. A potential feast for epidemiologists (and bloggers), coming at high risk for the children involved.

On the other hand, Waldorf-minded parents might be delighted. In the Steiner philosophy, measles (and other rashy diseases) help the kids mature:

At the higher emotional and mental levels, negative forces such as greed and selfishness have also been expelled. So a child who has measles is afterwards less self-centered and more openhearted, and often more able to express his or her individuality. The personality becomes rounder and fuller, and more joyful and contented, as a step towards maturity and adulthood.

And don't worry about complications or death, since

Serious complications in childhood illness which produce permanent damage or even death are probably deeply founded in the destiny of the person concerned.

Yes, totally out there, but so is the entire cult (see Melanie Byng's excellent three part series on DC's Improbable Science blog). Steiner Kindies and schools and anthroposophically minded doctors have therefore been doing a great job in keeping measles circulating and racking up impressive case numbers, like the 174 within 3 weeks at a 300 pupil Steiner school in Salzburg in 2008 or the 400+ cases in the practice of one doctor in the 1999/2000 measles outbreak in Coburg Bavaria.

Hopefully, this new outbreak will end with as few cases as the recent outbreak at Ozark Adventist Academy.

The Toxin Gambit Part 2: Polysorbate 80 and a Maths Fail

Previously we posted The Toxin Gambit 1: Formaldehyde which was an in-depth examination of what formaldehyde is, actual toxic doses and the amount in vaccines.  We feel these examinations are important for parents who have been frightened into believing that vaccine excipients are harmful when they are, in fact not, particularly in the amounts contained within vaccines.  A blogger who goes by the name of Amanda is one such person attempting to either justify her own fears of polysorbate-80 and/or trying to frighten others.  In either case she is demonstrably wrong with her interpretation of information and is a case study in why you should pay attention in maths classes.

I recently saw a woman on facebook complaining about teh ebil sodium chloride in vaccines, claiming "Sodium chloride: Raises blood pressure and inhibits muscle contraction and growth", channelling Natural News (the Nazi reference was missing from her post though). Did you know that vaccines contain up to 9mg/ml sodium chloride? Yes, that would be .9%, also known as "physiological salt solution" or "normal saline" - the stuff you can get intravenously in half litre amounts (BTDT) and that doesn't even sting when you clean wounds with it. Scientific illiteracy is rife among the anti-vaccine minded and I was just pointed to another example - this time, polysorbate 80 is the evil vaccine ingredient - the Blog "Blinded by the Light" comes up with a malware warning, so be careful when you click the link, I will copy and paste the best bits here, so you don't have to go (here is a pdf as downloaded Saturday morning). Amanda, the blog author, has a "holistic and spiritual paradigm" - maths and sciences are lacking from her approach though, so I am not sure she can claim the "holistic". She has several concerns about the use of Polysorbate 80 in vaccines:

According to the Material Safety Data Sheet (MSDS) for PolySorbate 80 there is no information available regarding carcinogenic, mutagenic, teratogenic, or developmental toxicity effects. [1]

There is information on toxicity though - the LD50 (dose at which half of the experimental animals die) is 34500 µl (microliter) per kilogram body weight - this is the equivalent of 24 teaspoons (or 36.6 grams, see below) full of pure Polysorbate 80 for a 3.5 kilogram newborn baby. A huge amount. Vaccines contain a maximum of 100µg per dose (that is threehundredandsixtyfivethousandsevenhundred [365'700] times less than the LD50 for a newborn, we ingest 1000x that (100mg) per day, since Polysorbate 80 is used as an emulsifier in many foods (for example ice cream, yumm). 

Amanda continues (her bolds and italics and underlines):

Reproductive Issues

I’m as apprehensive as the next guy when it comes to animal studies and results given. If you give a rat (or any animal for that matter) large doses of any chemical I’m sure cancer and health issues will ensue. However, this study is interesting.

A research group in 1993 studied the effects on the reproductive organs of rats with very small doses of polysorbate 80 which resulted in infertility. Specifically, they found that Polysorbate 80 accelerated the maturation of the female rats, damaged the vagina and womb lining, caused significant hormonal changes, severe ovary deformities and ultimately rendered the young female rats infertile. [3] 

To give you an idea by what I mean by very small. The dose given to the rats was 0.1 mcg. Compare this to the three-stage injection of the HPV vaccine Gardasil that would contain 50 mcg each injection. [3] [4]

If we assume the baby rats weighed 6 ounces (which  baby rats do normally weigh between 5-6 ounces), to be equivalent, the prepubescent teenage girl would have to weigh approximately 300 lbs.

Wow! That is horrible! Horribly wrong that is. Let me take you through this. We'll start with some basic measurements.

1 ml (milliliter = 1/1000th of a liter) of water weighs 1 g (gram)

1 ml = 1000 µl/mcl (microliter = 1/1'000'000th of a liter)

1 ml of Polysorbate 80 weighs 1.06-1.09 g, so it is a bit denser/heavier than water - I will calculate with 1.06 from here on.

An ounce is 28.35 g - 6 ounces are 170 g, about the weight of a full baby bottle.

300 lbs are about 137 kilograms (that is one big preteen).

Now let's see what the paper actually states:

So, neonatal female rats were injected with 0.1 ml of 1% or 5% or 10% Tween 80 (that is the same thing as Polysorbate 80, just a trade name) on 4 consecutive days. They were injected IP into the peritoneal cavity, which is in direct contact with the uterus. Now Amanda claims the amount given to the rat pups was 0.1mcg (=microgram) and calculates from there. That is wrong.

Remember, 1 ml weighs 1g (1 ml of Polysorbate 80 weighs 1.06 g, so I am going to go with that in the per rat calculations). Pups were applied 0.1ml = 0.1 gram. 0.1 gram is 100 milligram or 100'000 microgram. 1% of that is 1000 microgram (but since it was 1% of Polysorbate 80, 1060 microgram in 100 microliter). Pups were injected 4x with 1%, 5% or 10%, so they received:

1%: 4x1060 microgramm = 4240 microgramm (roughly forty two thousand times more than Amanda claims) 

5%: 4x5300 microgram = 21200 microgram

10%: 4x10600 microgramm = 42400 microgramm (or 42 mg)

What does a newborn rat weigh? Amanda sounds very authoritative when she states "5 to 6 ounces", but that is about as wrong as the rest – newborn rats pups up to the age of about 5 days are called "pinkies". This is why: they are the size and shape of a pinky and weigh about 8 g (less than a third of an ounce). When they are 7 days old, they are "fuzzies" – and weigh about 15 g (half an ounce). 

6 ounce baby bottle    -   3 day old rat pups    -     7 day old rat pups:

Notice how delicate their skin is and remember that the injection these pups have received did not go into the muscle (IM) or under the skin (ID) as vaccine, but IP, into the tummy essentially right next to the uterus.

We go on with an average weight of 12 gram per pup. Your 1% group will have gotten 353'333 microgram (or 353 mg) per kilogram bodyweight (1000/12 x 4240 µg). In order to apply the equivalent amount to a 50 kilo preteen (to stay with the Gardasil example), you would have to apply 17'667'000 microgram, or nearly 18 grams of pure Polysorbate 80 (that is 3.5 heaped tea spoons full - good luck getting that into three 0.5ml syringes).

Your three shots of Gardasil contain 150 microgram of polysorbate 80. In order to expose your preteen to the same amount of Polysorbate 80 that those pups (in the 1% group) got, she should weigh about 0.42 g or about the 12th of a teaspoon full (or 326'000 times less than Amanda claimed).

The wild speculation continues under the heading "Immunocontraceptive". Amanda cites a patent application for a vaccine intended to sterilise animals by vaccinating them with zona pellucida glycoprotein. The inventors explicitly propose to use Polysorbate 80 as an emulsifier, not an active ingredient and at the concentrations in the patent (0.2% in 0.5ml injected intramuscular) it is not going to do anything with the fertility of the recipient without the active ingredient.

Amanda's next worry is disruption of the blood brain barrier - according to her reference 10, not found in the citation list, already observed "at intrevenous systemic doses as low as 3 mg". That may or may not be true (since she doesn't reference the paper she refers to, it could be that those 3 mg were applied to 20 g mice), however, 3 mg are 3000 µg, vaccines contain between 25 and 100 µg of Polysorbate and are not given systemically (despite the "directly into the blood stream" canard that the anti-vaccine minded like to use).

Edited on 24 Sept 2012 to add: Amanda has very kindly come up with reference 10, which in turn cites this 1985 paper for the actual experiment. 25-35g mice (young adult females) were intravenously injected with 3 milligram per kilogram of polysorbate 80 together with methotrexate. If you upscale this to your 50 kilo preteen (3mg/kg), she'll need 150 mg (150'000 microgram) IV to be able to expect an effect on the blood brain barrier. However, vaccines contain 1500 to 6000 times less polysorbate 80 than that and are given into the muscle and not into the blood stream. -end edit-

It is sad that Amanda went out, equipped with very little understanding of maths, immunology, chemistry, or animal experiments, seemingly with the intention to be scared (and to scare)? 

Chalkboard is the New Comic Sans

It seems that Chalkboard is replacing Comic sans as the font of choice for woo. This image is popping up on all sorts of Facebook pages:

Not once? Nope, every time a new vaccine is licensed, it is tested against the current schedule (and the old vaccine against the same disease, if there was one). We had previously addressed this anti-vaccine lie - here is the list, by no means exhaustive, as a reminder:

Hexavac with Hepatitis A

Hexavalent vaccine with Rotateq

DTaP with Hib

PCV-13 with all infant vaccines

MMR and Varicella

PCV-7 with MMR, Hib and Varicella

Pediarix with Hib and Infanrix-hexa

New Hib with all infant vaccines

MMR with Varicella

MMR-V with Hib-HepB

MMR-V with all infant vaccines

Meningococcal-C with Hep B and Pentacel

Pentacel with PCV-7

Lies do not become "truer" when you use chalkboard - take the course if you don't believe us.

ETA: ohh look, the Skeptical Raptor has expanded on the links, so you don't have to click on every one of them.

"QUACK" says the Quack, the Board says "NEIGH" - it's quiet now, what do you say?

with apologies to Sandra Boynton

On 22 August 2012, the Maryland State Board of Physicians revoked Mark R. Geier's license to practise Medicine (dare I say "finally"?). This follows almost a year of legal proceedings (covered very well by Todd W. at Harpocrates Speaks, here, and here and by Kathleen Seidel at Neurodiversity.com, here and here) - visually:

On September 15, 2011, the Board charged Mark R. Geier, M.D., with numerous violations of the Medical Practice Act, including: (1) unprofessional conduct in the practice of medicine; (2) willfully making or filing a false report or record in the practice of medicine; (3) willfully failing to file or record any medical report as required under law; (4) practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine; (5) grossly overutilizing health care services; (6) failing to meet appropriate standards for the provision of quality medical care; and (7) failing to keep adequate medical records, under Md. Health Occ. Code Ann. § 14-404(a) (3) (ii), (11), (12), (18), (19), (22), (40), respectively. 

A five-day evidentiary hearing was held before an Administrative Law Judge ("ALJ") ofthe Office of Administrative Hearings in December of 2011. On March 13, 2012, the ALJ issued a Proposed Decision finding that Dr. Geier had violated numerous provisions of the Medical Practice Act and recommending that his license be revoked. Exceptions and responses were filed by both parties. An oral exceptions hearing was held before the full Board on May 23, 2012. This Final Decision and Order is the Board's final administrative decision in this case.

Carole J. Catalfo, the Executive Director of the Maryland State Board of Physicians has had it. Her ruling leaves nothing open to interpretations - she finds (footnotes removed):

(1) Dr. Geier failed to meet basic medical standards for evaluating patients and conducting medical examinations and keeping adequate records of treatments and diagnoses. He failed to conduct an adequate initial evaluation of any of these patients and failed to make an adequate record of an examination for any of these patients. He began treatment often without sufficient information about the patients' physical condition. In many cases, [Dr. Geier] had no information at all about the Patients' physical condition.,

This is consistent with the details that came out in the case of Dr Geier's son David Geier practising Medicine without a license (Justthevax passim). She further finds:

(2) Dr. Geier treated patients with Lupron, a medication that is not approved by the FDA in the absence of precocious puberty. He did not, however, perform an adequate examination to determine whether these patients had precocious puberty, or the cause of these patients' symptoms. ../.
(3) Based on his theory that Lupron therapy is appropriate in certain situations in which its administration is not approved by the FDA or the American Academy of Pediatrics, Dr. Geier purported to treat patients who met his profile with Lupron. With the exception of Patient E, however, none of these patients met even Dr. Geier's profile for Lupron therapy.

This abhorrent practise to "diagnose" any child with "precocious puberty" irrespective of age and physical evidence to be able to prescribe Lupron, a strong hormone modulator, which essentially equals chemical castration is part of Team Geier's proprietary theory. They postulate (I paraphrase - see père et fils Geier here) that excessive testosterone binds mercury from vaccines in the body/brain, and that the administration of Lupron will release the mercury which can than be chelated. That is complete gobbledygook of course, but unfortunately, far too many parents believed them (read Kathleen Seidel's outstanding series on "The Lupron Protocol") - the Geiers claimed to have treated more than fifty children already in 2006. Consequently, following Lupron prescription:

(4) Dr. Geier prescribed chelation therapy to patients who failed to display the need for chelation. He began this therapy without documenting a reason for the treatment and without adequate documented informed consent. He violated the standard of quality care by so doing. He also violated the standard of quality care by prescribing for patients the drug DMPS, a drug not approved for any use in the United States.

(5) Dr. Geier provided a consent form to the parent of Patient I that named an FDAapproved drug and which falsely stated that it was to be used in the chelation treatment when another drug, DMPS, which was not FDA-approved, was to be used (and in fact was used) in the chelation treatment. 

It gets worse:

(6) After prescribing these treatments without an adequate previous medical examination and without adequate informed consent, Dr. Geier then failed to adequately monitor whether these treatments were working.

"Experimental" treatments on human patients will have to undergo review by an institutional review board, which is supposed to advise and control the physicians. The Geiers' review board was made up of family and friends:

(7) Dr. Geier provided drug therapy to Patient I according to a protocol not approved by the FDA after telling the parent that his protocol was approved by an Institutional Review Board, when in fact the Institutional Review Board consisted entirely of persons affiliated with his practice and did not meet the requirements of federal or state law.

The court further finds that Dr Geier had parents sign an "informed consent" form that named the wrong drug (FDA licensed) to be applied, while an unlicensed drug ended up being used on their children (8). He inflated his credentials, claiming an American Board of Medical Specialties certification he did not have (9). The Board also finds that the record keeping of Dr. Geier was too poor to even be suitable for assessing patient progress. Nevertheless, he made decisions to continue or alter medication (10). Dr. Geier falsely made a diagnosis of precocious puberty in patients who did not have this condition and he did not perform the necessary medical examinations to be able to make this diagnosis (11). 

It appears that Mark Geier had objections to Dr. Grossman as an expert witness, saying that she was not a "true peer". Given her impressive list of qualifications, I would almost tend to agree with that notion - the court states:

Dr. Grossman is board certified in pediatrics and developmental-behavioral pediatrics and has been an Associate Professor of Pediatrics, the Director of the Behavioral and Developmental Pediatrics Fellowship Program at the University of Maryland School of Medicine and the head of the Division of Behavioral and Developmental Pediatrics at that institution. She has also held many other positions of great responsibility in her 35-year career in pediatrics. She testified knowledgeably about the standard of care applicable to pediatric patients in general and to these patients in particular. The Board is satisfied that she was appropriately admitted as an expert in this case.

I felt like hugging Carole Catalfo for the following statement:

The fact that she may not have been familiar with the details of some of Dr. Geier's idiosyncratic theories, theories that appear to be supported in large part by literature that he or his son created and which have been rejected to some extent by the Institutes of Medicine of the National Academy of Science, does not detract from the weight of her testimony about the quality of the actual medical treatment provided to these patients, in the Board's opinion.

True that! The deconstruction of Mark Geier continues, as Dr Catalfo observes:

Dr. Geier, however, is not a "trained clinician." He completed only a one-year residency in obstetrics and gynecology, has no formal specialized training in the treatment of autism, and is not Board certified in any medical specialty.

The board also had few good words about the statements of Dr. Jerry Kartzinel (if the name rings a bell that is because you have seen him on this with Andy Wakefield):

The Board also notes that Dr. Kartzinel's testimony on the adequacy of Dr. Geier's physical examinations of these patients was particularly unpersuasive. ../..

He testified that a physical examination of the patients is highly overrated (Tr. 200) and that the physician "generally ... can bide by his eye" (Tr. 148-49) and just try to "get a gestalt," and that it is not even necessary for the physician to document that "gestalt" in the medical record. (Tr. 182) It is sufficient for the physician then to "step back and say, did I get a clinical response that everybody is thrilled with, or was it a swing and a miss," according to Dr. Kartzinel. (Tr. 155) In the Board's opinion, what Dr. Kartzinel describes as an acceptable medical examination and mode of treatment is not acceptable at all, and it is questionable as to whether this conduct can even be described as "medical."

Traurige Gestalt* is more like it. The hubris that those phrases reveal is not untypical amongst the "brave maverick doctors".

In their ruling, the State Medical Board do not speak to the allegation that Dr. Mark Geier let his unqualified son, David, practise Medicine. The Board state that this is being dealt with elsewhere (it has been) and that:

The Board will not make a decision in this case on this same factual issue based upon the less complete record made in this case. In light of the egregious violations of the standard of quality care and the deliberate unprofessional conduct set out in the numbered facts recited above, a decision as to whether Dr. Mark Geier also allowed Mr. David Geier to practice medicine without a license would have no effect on the sanction that the Board would impose on Dr. Mark Geier.

Read the Sanction in full, very slowly, word by word to understand that these proceedings dealt with a high number of unambiguous violations and there is really no room for a "misunderstanding" of what happened:

The ALJ commented that Dr. Geier abused the trust that these patients' families placed in him. "By dissembling, misrepresenting, failing to see his patients for months and years before treating them, applying a protocol-based treatment to children who do not fit the protocol, using non-FDA-approved drugs without fully informed consent, and for all of the other violations found and discussed in this Proposed Decision, he abused that trust. I agree with the State that these actions betray the relationship of a physician to a vulnerable child and his desperate parents."
The Board agrees.
The ALJ proposed that the Board revoke Dr. Geier's license. Dr. Geier has displayed in this case an almost total disregard of basic medical and ethical standards by treating patients without properly examining or diagnosing them, continuing treatment without properly evaluating its effectiveness, and providing "informed consent" forms that were misleading and in at least one case blatantly false. He provided treatments supposedly according to an investigational protocol, but the investigation was approved only by a sham Institutional Review Board, and he applied protocols to patients who did not fit his own profile. He provided treatment by a drug not approved for use in this country while informing parents that a different drug would be used. His actions toward his patients were not those of an honest and competent physician, nor do they appear to be those of an objective and ethical researcher. Dr. Geier made little use of those methodologies that distinguish the practice of medicine as a profession. At the same time, he profited greatly from the minimal efforts he made for these patients. In plain words, Dr. Geier exploited these patients under the guise of providing competent medical treatment. Such a use of a medical license is anathema to the Board. The Board has no hesitation in revoking his medical license.

Which they do:

What do I say? For the moment, I remain very quiet and listen to the weeeeeee sound that the Geiers' descent makes - they have been falling for a while and they have not hit rock bottom yet. It is likely that the repeated practising Medicine without a license and the number of other behaviours that led to this license revocation will have further consequences (like fines or even jail time). I also think that some insurance companies might want to have another look at the diagnosis and prescription practise of Dr Geier. Some parents (especially if they had to pay out of pocket) might want their money back.

Most of all though, as a parent, I am relieved that vulnerable children are safe from unlicensed drugs in uncontrolled treatment of undiagnosed conditions based on untrue hypotheses. My hope is that those who were treated with Lupron will not have sustained permanent damage and will find trained specialists to take care of their (hormonal and other) needs.

*sad figure

Hat tip to Stephen Barrett, MD

ETA: now also very nicely covered by Todd W. on Harpocrates Speaks

Back to school for unvaccinated pupils after measles in Arkansas

Well, colour me surprised - pleasantly surprised. After two pupils came down with measles in Ozark Adventist Academy (Justthevax passim), the other (8?) unvaccinated pupils had to be sent home. After confirmation of those cases, I already had the headline for a blog about subsequent cases written in my head (it had something to do with bears and woods), but herd immunity and quarantine are miraculous things and apparently, no more cases have been reported (see Arkansas Department of Health), so OAA calls their pupils back to school from Monday:

Measles Update
September 13

The measles outbreak has been contained to the original family. All vaccine-exempt students may return to school September 17 if they have their annual filing for vaccine exemption up to date as required by the Arkansas Department of Health.

I am very pleased (it would even be better if those students kept at home had decided to catch up on their MMRs).

Chicken pox vaccination policy in the UK - did it cost Elana's life?

The UK is often cited in discussions about the chicken pox vaccine. After all, they are a perfectly developed country, they even speak (vaguely) the same language as the US and the NHS's chicken pox policy spells out what (US) vaccine critics have known all along: the disease is harmless in children and vaccinating against it will increase the incidence of shingles in the older population.

The chickenpox vaccine is not part of the UK childhood vaccination programme, because experts think that introducing a chickenpox vaccination for children could increase the risk of shingles in older people. ...

Chickenpox is usually a mild illness, particularly in children. 

This view has been repeatedly challenged. The BBC claimed cost as one major reason the NHS doesn't provide the varicella vaccine and cited Dr David Elliman, immunisation expert at the the Royal College of Paediatrics and Child Health (RCPCH), stating that MMR fears need to be overcome in the UK before a further live viral vaccine could be successfully introduced (more suffering due to the Wakefield/MMR/autism manufactuversy):

"The chickenpox vaccine is definitely desirable, and I think it it will happen, but unfortunately I don't think we are ready for the debate yet - not until we get MMR rates back where they need to be. We need to win that one first."

This is particularly cynical since more patients are dying of chicken pox in England and Wales every year than from pertussis, mumps, measles and hib combined.

Mortality from chickenpox is not negligible. During
1995/­7, 81 deaths were recorded by the Office for
National Statistics. However, we received 119 certifi-­
cates that mentioned chickenpox or varicella. After
detailed inquiries, we estimated that at least 75 were
genuine cases of chickenpox. This suggests at least 25
deaths from chickenpox annually. In 1996/­7 there were
seven certified deaths from whooping cough, mumps,
measles, and Haemophilus influenzae type b (Hib) men-­
ingitis in England and Wales compared with 67 from
chickenpox.

In the meantime, children are either protected by a varicella vaccine purchased privately from a travel clinic (if parents are 1. aware of the option and 2. tenacious enough to find a clinic 3. well off enough to afford this), or they have to suffer through chicken pox. Elana had to have chicken pox and while her brother, who had them first, had a mild case, Elana developed pox in her lungs and died. Just like that:

Elana was three years old when she came out in spots on Easter Sunday 2009. She was fit and healthy and, as her brother had fended off a fairly mild dose of chickenpox the week before, I wasn’t worried. What was to follow has changed my family’s lives forever.

That evening, Elana was a bit tired and wanted to curl up in front of the television but she didn’t seem particularly ill – her spots were not even particularly itchy. But as the week progressed, she seemed to get more lethargic and her condition worsened.

By Thursday, the spots had started to crust over and I thought she should have been getting better but there was no improvement. On Friday night I called the emergency GP and went to a community health centre to have her looked at. The doctor diagnosed Elana with possible pneumonia and recommended that we take her straight to the hospital.

By 11pm on the Friday night we were in hospital and Elana was very unwell. At 6.04am on Saturday morning she suffered a cardiac arrest. Elana was pronounced dead at 7am.

The UK Department of Health touted the party line:

We wrote to the UK government but the Department of Health says severe cases of chickenpox infection are rare and occur mostly in immuno-compromised children. However, I can say from witnessing it first-hand that my daughter was fit and healthy before she picked up the virus. In fact, Elana only ever needed to see a doctor when she was having routine immunisations. I know some other parents who have had the same experience.  

Elana's mum is now spreading awareness of the potential dangers of chicken pox and the availability of the vaccine. It is striking that in the UK, the vaccine is such a well-kept secret that even she, as a nurse, was not aware of it. So: help her - don't let the death of her precious daughter have been wasted. Talk about the vaccine as a real option, tell your neighbours, your GP, your MP, post it on Mumsnet and other fora.

Oh, Pout, *I* Was Going to Tackle This One Next and Orac Scooped Me

I was going to pitch it under the "concern troll" heading, but Orac saved me the work - please go and read

Respecting parental concerns versus pandering to antivaccine fears

It summarises my thoughts on "anti-vaccine wolf" in "concerned citizen sheep" skin just beautifully :)

much ado about timing of measles shot

A newspaper snippet is making the round on the interwebz...

Timing of measles vaccine questioned Quebec had a large outbreak of measles in 2011, with more than 700 cases reported. Surprisingly, a number of the teenagers infected had received the recommended two doses of vaccine. A study De Serres did last year showed those who got their first shot at 12 months of age were three times more likely to get infected than those who got their first shot at 15 months of age; his new study put the risk at six times more likely.

We know what will become of this in the claws hands of anti-vaccine vaccine-critical folk. "An outbreak in Quebec where 700 vaccinated teens got measles proves that current vaccination schedule makes teens six times more likely to contract measles". So let's look at the actual study: It analyses measles cases in one high school in Quebec with 1306 students. The index case was a teacher, who imported the measles. This teacher had been vaccinated once. Passive and active surveillance identified 110 students with measles in the following outbreak - I'll bold the notable passage:

Of the 110 student cases identified, 98 were therefore classical (23 laboratory confirmed) and 12 were attenuated (Table 2). Attenuated cases were only found in 2-dose recipients, none of whom had been revaccinated as part of outbreak control.

So out of 1306 pupils, 110 got sick, 12 of them mildly. Mild cases had been vaccinated twice. Have a look at this handy little table:

The overall attack rate among unvaccinated students was 82%,
the overall attack rate among vaccinated students was 4.8%.

Vaccine efficiency was 95.9% for one dose of MMR. It was 95.5% against classical measles and 94.1% against any measles in the 2x vaccinated group. The authors then analysed the 2x vaccinated students to see whether vaccine protection waned with age. That was not the case. Instead they found that for students who were vaccinated at 12 months, vaccine efficiency was 93%, whereas in students who had had their first MMR, it was 97.5%. When you compared those two groups with each other, the relative risk of the 12-months-at-first-vaccination to contract measles compared to the 15 monthers was about 4.35x higher, which was borderline significant (p=0.04). That bit made the news. The fact that measles vaccination offered highly significant protection against measles somehow didn't. Well, now you know.

5 Minutes with Ben Goldacre on what is "bad science" and what is "good science"

Those of you who don't know Dr. Ben Goldacre - go and buy and read his book "Bad Science", now. It may be a bit Britain focussed for the non-Brits out there, but it is a great introduction on how the media and snake oil salesmen and -women take advantage of us and reading the book and understanding its principles will protect you, your health and your wallet. Ben Goldacre takes on the great manufactroversies, like the one about MMR on his blog, his book, in talks he gives, in wonderful short films on health (for example placebo) and in testimony to the British Parliament, and so his debunking work is directly linked to public health (and vaccines). The BBC have interviewed Ben Goldacre in their "5 Minutes with... series" - have a look at the author (and go get the book if you haven't).

Oh, and should you be tempted to comment "pharma shill" or something the like, read one of the below (paperback out on 27 September 2012) on an empty stomach and call me in the morning...