Sheep vaccine study – aluminum adjuvants alter their behavior

sheep vaccine study

Over the past 20 years or so, I’ve read a lot of vaccine research studies. Most, published in top journals by real scientists, are worthy of respect. And they provide powerful evidence that vaccines are safe and effective. Of course, there are a handful of studies that are pseudoscientific garbage. Or retracted. But today, I think I’ve seen it all – a Spanish animal research team published a sheep vaccine study that they claim shows that the aluminum adjuvants in the vaccine altered their behavior. And you just know that the anti-vaccine religion will jump all over it as “proof” that vaccines are dangerous. Yawn.

In case you missed it, yes, this is a sheep vaccine study.

To be fair, I have no idea whether these researchers are part of the anti-vaccine religion – it’s possible that they think they’ve found something, but they do rely upon some discredited anti-vaccine tropes and falsehoods as the premise of their studies. Moreover, this article furthers the false narrative about aluminum in vaccines. And we’ll keep seeing it repeated on anti-vaccine Twitter and Facebook posts because the anti-vaccine zealots have nothing else.

The sheep vaccine study by Javier Asìn et al., published in Pharmacological Research, investigated cognitive and behavioral changes in lambs that had received repeated vaccination with aluminum-containing vaccines.

Let’s take a critical look.

Sheep vaccine study results

I’m not going to spend much time with the results, because I find it very troubling that the author’s conclusions are based on a total study of 21 animals, seven in each group. I laugh at clinical trials in humans that don’t contain 1,000 or more patients or epidemiological studies that don’t include a sample population over 100,000. An animal study that includes 21 lambs ranks near at the bottom half of the hierarchy of biomedical research.

The researchers put those 21 sheep into three equal groups:

A. Control group

B. Adjuvant only group

C. Vaccine with adjuvant group

I will get to a criticism below, but based on the small experiment, the authors concluded that:

Animals in groups B and C exhibited behavioral changes: affiliative interactions were significantly reduced and aggressive interactions and stereotypies increased significantly. They also exhibited a significant increase in excitatory behavior and compulsive eating. In general, changes were more pronounced in the Vaccine group than they were in the Adjuvant-only group. Some changes were already significant in summer, after seven inoculations only. This study is the first to describe behavioral changes in sheep after having received repetitive injections of Al-containing products, explaining some of the clinical signs observed in ovine ASIA syndrome.

Aluminum in vaccines

For those of you who are unfamiliar with aluminum in vaccines, aluminum adjuvants are added to vaccines to stimulate the immune response to the vaccine’s antigen – however, they do not induce any immunity to anything by themselves.

Aluminum adjuvants have been used for over 70 years in vaccines without any evidence that they cause harm. Unfortunately, these adjuvants have only become an issue for the anti-vaccine world because they keep running out of real science to support their beliefs about the safety of vaccines.

There are a few key points to be made about aluminum adjuvants:

  1. The amount of aluminum in vaccines (and remember, only a few vaccines have aluminum) is measured in micrograms. The maximum allowable amount of aluminum in a vaccine is 125 µg.  Based on the recommended schedule of vaccines, the maximum amount of aluminum an infant could be exposed to over the first year of life would be 4225 µg (or 4.225 mg). Let’s put this into context – a newborn baby averages body burden of about 384 µg of aluminum. In addition, typical concentrations of aluminum in breast milk (10-49 µg/L), soy-based infant formula (460-930 µg/L), and milk-based infant formula (58-150 µg/L) mean that the dose of aluminum from these sources far exceed the dose of vaccines in just a few weeks. A baby also inhales several thousand micrograms of aluminum per day, unless they live in some bubble with ultra-pure air.
  2. As I constantly mention, the dose makes the poison. And these doses of environmental and vaccine aluminum are far below the minimum risk level for the body burden of aluminum.
  3. Only if you assume that the body cannot clear aluminum (usually only in the case of kidney failure), the cumulative dose of the metal doesn’t actually matter.
  4. There is a trope, pushed by the anti-vaccine world, that somehow injecting aluminum is much different than consuming or inhaling it. This is simply not based on any science known to the biomedical world. The kidneys filter out most of the aluminum salts way before it accumulates. Furthermore, inhaled and ingested aluminum occurs every single day unless your baby doesn’t eat or breathe, whereas the tiny dose of injected aluminum occurs infrequently.

There simply is no robust, peer-reviewed evidence that the amount of aluminum salts in vaccines are in any way harmful. But that never stops the anti-vaccine religion from making unfounded claims.

ASIA, not the continent

Asin et al. start out their paper by stating that autoimmune syndrome induced by adjuvants (ASIA) is an adverse reaction of vaccines. ASIA is a belief, pushed by Israeli immunologist Yehuda Shoenfeld, that certain autoimmune conditions are caused by aluminum adjuvants in vaccines.

However, ASIA has been thoroughly dismissed by most scientists and regulatory agencies. Numerous large case-control and cohort studies, both near the top of the hierarchy of biomedical research, have found no evidence of a relationship between vaccines, especially the HPV vaccine, and ASIA. For example, researchers looked at nearly 300,000 vaccinated and unvaccinated women (reviewed here) and found no link to ASIA. There are many more studies that show a similar lack of causal links.

Thus, before we even start critiquing this paper, the authors start with a bogus hypothesis that is unsupported by real scientific investigations. Unless, of course, you subscribe to anti-vaccine lies, memes, and tropes. Then you probably are a true believer.

Sheep vaccine study critique

Despite the fact that the paper has a couple of discredited claims, about aluminum and ASIA, there are other significant issues with the paper. Let’s review:

  1. The researchers only looked at a total of 21 sheep in 3 groups. Important clinical and epidemiological studies have thousands or even millions of data points. It is difficult, if not impossible, to determine a causal link with such a tiny sample size.
  2. The animals in the two experimental groups, one vaccinated with the typical vaccines given to sheep and the other with just aluminum adjuvant. The animals received 16 vaccine doses within 12 months for a total of 70.861 mg of aluminum. These are the number of doses that a sheep receive over 6-7 years! Furthermore, if you’re prone to comparing sheep to humans, that’s 20X more aluminum adjuvant than a human receives over a year – of course, human infants are smaller. Nevertheless, even though I dismiss any link between injected aluminum and neurological issues, giving 6-7 years of vaccines over 12 months biases the results. In addition, I’m skeptical of the behavioral observations, but it is possible that the serum aluminum levels are so high that it exceeds the safe limit for aluminum.
  3. The study was not randomized or blinded (or they failed to mention it in the methods section). You might think that randomization on matters with humans, but the researchers could have biased the results by the way they treated the sheep.
  4. This study relied upon subjective observations of the sheep’s “behavior” post-vaccination. These are the type of issues that hinder many behavioral and neurological studies – a subjective analysis of change in behavior is almost impossible to quantify. And when there are just 21 animals, it’s almost impossible.
  5. Sheep are social animals and the process of vaccination itself, especially so many over a short period of time, may induce behavioral changes irrespective of any contents of the vaccine, although the control group did receive a placebo injection.
  6. This sheep vaccine study is a primary research article – that means it lacks any supporting data anywhere else. It’s like the old vaccines cause autism canard – one retracted study supported it. On the other hand, literally hundreds of clinical and epidemiological studies along with meta-reviews have debunked that claimed link. That’s why most real biomedical researchers ignore primary animal studies – they pique interest, but rarely form the foundations of science-based medicine. Since we have dozens of studies that show no behavioral changes post vaccination, how much does a very small, very poorly designed sheep study tell us? Next to nothing.
  7. In a 2013 study by the same research group, they observed that around 0.5-1.0 % of animals of a flock exhibit the type of behavioral symptoms, irrespective of vaccination, described in the newer paper – yet they conveniently ignore it. Given the tiny sample size, the lack of randomization or blinding, and other issues, it’s impossible to tell if this is background noise.

I’m done here

The anti-vaccine religion has pounced on this study, which doesn’t surprise me or any other pro-science person out there. Dr. Bob Sears (the California pediatrician on probation for some issues about vaccine exemptions) and the crackpot science denier Robert F Kennedy Jr have tried to abuse this pathetic study to further their pro-disease for children beliefs.

This sheep vaccine study barely rises to the level of bad evidence – it provides us with nothing useful about the discussion regarding aluminum in vaccines. Moreover, there is overwhelming evidence, as shown in so many powerful peer-reviewed studies, that there simply is no link between aluminum adjuvants and anything.

Why do the anti-vaccine use this terrible sheep vaccine study to support their claims? Because they’ve got nothing else. Nada. Squat. Zilch.

Citations

Aluminum adjuvants in vaccines – another attempt for something, anything

aluminum adjuvants

Here we go again, another attempt to link aluminum adjuvants in vaccines to something, despite the lack of real evidence for anything. Recently, an attempt by the disreputable pair of anti-vaccine researchers to show a link between aluminum adjuvants and autism was retracted by the journal.

Several researchers have proposed a systematic review (which are considered to be the pinnacle of the hierarchy of biomedical research) to determine if there are any links between aluminum adjuvants in vaccines to some medical condition. Read that carefully – this paper does not provide any new evidence, it is merely a description of their reasons for looking at aluminum along with the meta-review protocol.

Mostly, I’d ignore these type of papers, because they aren’t providing us with any new information about vaccines. But in this case, I wanted to point out a bunch of flaws in their reasoning, which seems to indicate a high degree of bias. Therein is the problem – systematic reviews are powerful tools in science-based medicine, but many of these systematic reviews are filled with a large amount of bias. And this study is starting from a very biased point of view. Continue reading “Aluminum adjuvants in vaccines – another attempt for something, anything”

Anti-vaccine paper retracted – Shaw and Tomljenovic lose again

Anti-vaccine paper retracted

A few weeks ago, I wrote a critical analysis of a paper by Christopher Shaw and Lucija Tomljenovic published in Inorganic Biochemistry that tried to convince us that aluminum adjuvants in vaccines caused autism. Predictably, it’s another anti-vaccine paper retracted by another journal.

Shaw and Tomljenovic have quite a history in retracted anti-vaccine articles. Last year, they wrote an article about aluminum adjuvants in the HPV vaccine – it was retracted, and eventually republished almost word-for-word in an inferior journal.

According to Retraction Watch, Inorganic Biochemistry’s editor, John Dawson of the University of South Carolina, stated that:

The paper by Shaw and co-workers is being retracted jointly by the authors and the editor.

Yup, another anti-vaccine paper retracted. Of course, the article was roundly criticized in numerous posts across the skeptical universe soon after it was published. For example, the piercing Orac wrote in his blog,

given Shaw and Tomljenovic’s history, it is not unreasonable to be suspicious of this study as well…

At best, what we have here are researchers with little or no expertise in very basic molecular biology techniques using old methodology that isn’t very accurate overinterpreting the differences in gene and protein levels that they found. At worst, what we have are antivaccine “researchers” who are not out for scientific accuracy but who actually want to promote the idea that vaccines cause autism….If this were a first offense, I’d give Shaw and Tomljenovic the benefit of the doubt, but this is far from their first offense.

Orac called the paper, “antivaccine pseudoscience.” Not that anti-vaccine is anything but pseudoscience.

Other bloggers, like The Mad Virologist, who is also an expert on DNA analysis, and the Blood Brain Barrier Scientist, who writes about the blood-brain barrier and heavy metal music, jointly analyzed the paper by Shaw and Tomljenovic. They did a masterful job in looking at some of the technical errors and other issues with the paper. I won’t pretend to summarize what they write, so I’ll use their own summary:

Based on the methods that were used in this paper, Shaw et al. went too far in declaring that aluminum adjuvants cause autism. But there are six other key points that limit what conclusions can be drawn from this paper:
1) They selected genes based on old literature and ignored newer publications.
2) The method for PCR quantification is imprecise and cannot be used as an absolute quantification of expression of the selected genes.
3) They used inappropriate statistical tests that are more prone to giving significant results which is possibly why they were selected.
4) Their dosing regime for the mice makes assumptions on the development of mice that are not correct.
5) They gave the mice far more aluminum sooner than the vaccine schedule exposes children to.
6) There are irregularities in both the semi-quantitative RT-PCR and Western blot data that strongly suggests that these images were fabricated. This is probably the most damning thing about the paper. If the data were manipulated and images fabricated, then the paper needs to be retracted and UBC needs to do an investigation into research misconduct by the Shaw lab.

Taken together, we cannot trust Shaw’s work here and if we were the people funding this work, we’d be incredibly ticked off because they just threw away money that could have done some good but was instead wasted frivolously. Maybe there’s a benign explanation for the irregularities that we’ve observed, but until these concerns are addressed this paper cannot be trusted.

Also, a lot of criticism occurred on PubPeer, a website devoted to a kind of extended peer review of published papers. The commenters were harsh. Oneclaimed that there was a “clear and deliberate” removal of control results in the paper. And many others either hinted or outright stated that DNA gel bands were duplicated, photoshopped or taken from a 2014 paper by Shaw and Tomljenovic (and published in a journal that’s not even indexed on PubMed).

Added to all of this is that the primary author has left the University of British Columbia, where Shaw and Tomljenovic do their “research,” taking all of the data with her. I don’t mean to be cynical, but I will be – yeah right.

As an aside, I don’t know why the University of British Columbia continues to house Shaw and Tomljenovic. They have had their “research” utterly discredited by the World Health Organization. They have had papers retracted. And when they do publish, they’re in low ranked, low impact factor journals. Finally, their “research” is supported by some of the most profoundly anti-vaccine sponsors in the world.  Frankly, the only good Shaw and Tomljenovic do for the anti-vaccine world is to allow those of us who are pro-science/pro-vaccine lots of fodder in embarrassing the anti-vaccine world.

So there we go. Another Shaw and Tomljenovic anti-vaccine paper retracted, and will probably be republished in the Journal of Homeopathy Vaccines (no, it doesn’t exist). By the way, I won the betting pool on when it would be retracted. Hopefully, the shills pay me for winning.

Citations



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H1N1 flu vaccine – highly efficacious in preventing influenza in children

H1N1 flu vaccine

The influenza A subtype H1N1 was responsible for the 2009 flu pandemic, the last flu pandemic to strike the planet. It was estimated to have killed 477 children in the USA alone. In response to the 2009 pandemic, the H1N1 flu vaccine was first released to be used in an attempt to contain the pandemic.

The vaccine was introduced in 2009, and it has been part of many flu vaccines since that time. There has been some discussion about the effectiveness of the vaccine, but most studies showed it to be very efficacious.

A systematic review, considered the pinnacle of the hierarchy of scientific evidence, was recently published in the journal Vaccine, included well designed studies to examine the effectiveness of the H1N1 flu vaccine in both children and adults. The investigators identified 38 studies published between June 2011 and April 2016 that met the inclusion criteria for this meta-analysis – that is, any paper that focused on the H1N1 vaccine effectiveness during the 2009 pandemic. The data included data from over 7.6 million patient records derived from several different study designs.

This review also examined the differences between adjuvanted, that is, those vaccines that contain an adjuvant to boost the immune response to the flu antigens, and unadjuvanted (no adjuvants) versions of the H1N1 flu vaccine. The children’s version of the vaccine only included adjuvanted version.

The results of the study were clear. The pooled adjuvanted H1N1 flu vaccine efficacy in 1126 children was around 86% – this is an impressive number. In the pooled data for the adjuvanted and unadjuvanted versions of the vaccine, results showed that there was moderate protection of around 49% efficacy in people older than 18 years. Similarly, in individuals older than 50 years, the data showed the vaccine efficacy for the adjuvanted vaccines was approximately 46%.

This lower efficacy in older adults has been observed in other flu vaccine studies. Although there’s no conclusive reason why there is a lower efficacy, there have been several hypotheses offered including a less fit immune system for individuals, or that the population of older adults may have already have some immunity to H1N1 through previous pandemics or circulating H1N1 subtypes.

The authors concluded the following:

We further explained the overall inverse gradient between effectiveness and age by comparing adjuvanted versus unadjuvanted vaccines in each age band. Our results show that adjuvanted vaccines were significantly more effective in children than unadjuvanted vaccines in preventing laboratory confirmed influenza illness by almost a twofold difference in effectiveness. A similar pattern was also seen for hospitalization.

However, in adults there were fewer apparent differences between the performance of adjuvanted and unadjuvanted vaccines for both outcomes. The higher effectiveness in children of adjuvanted vaccines compared to unadjuvanted vaccines noted here has also been seen in efficacy studies of seasonal trivalent influenza vaccines (TIV) in young children up to 72 months of age, in whom efficacy against PCR-confirmed influenza was 92% for adjuvanted vaccines versus 45% for unadjuvanted vaccines.

The authors also asserted that this data is important for public health policy with respect to the H1N1 flu:

Evidence from modeling studies suggests that children are a credible target group for pandemic vaccination, along with patients who have high-risk conditions.

Once again, this is robust and exciting evidence of the effectiveness of the H1N1 flu vaccine against that flu subtype. The flu vaccine is often the ignored vaccine for children, probably because of enduring myths that the flu isn’t that dangerous or that the flu vaccine isn’t very effective. The H1N1 flu is dangerous, and it can be effectively prevented by the vaccine. So please, protect your children (and yourselves) with this vaccine.

 

Citations

Vaccine injury compensation and autoimmune syndromes

Vaccine injury compensation and autoimmune syndromes

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the second of two claims (see first one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on vaccine injury compensation and autoimmune syndromes.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

The NVICP (commonly called the Vaccine Court) is a no-fault program created by Congress to serve two goals: to protect the vaccine supply by offering limited liability protections to vaccine manufacturers and providers and to help those injured by vaccines – or even those who may have been so injured – be compensated more easily than in the regular courts.

As I addressed in the past, NVICP provides petitioners – as claimants are called – with substantial breaks compared to the regular courts. Petitioners do not have to prove a product defect or any kind of fault; the requirements for proving causation are relaxed; evidentiary rules are relaxed, allowing the introduction of evidence and experts that would not be allowed in a regular court.

NVICP is not, however, a benefits program. Its goal is not providing any parent with a child with a problem support. The United States certainly needs to offer more support to families of children with disabilities, but NVICP’s aim is different: it focuses on compensating injuries that may, at least, have been caused by vaccines.

To be compensated by an NVICP decision a petitioner does need to meet minimal standards suggesting a possible connection between a vaccine and an injury (a settlement does not require similar proof; parties settle for all kinds of reasons, including a view that the case isn’t worth litigating). At the very least a petitioner needs to show an injury, and provide expert testimony (expert testimony is generally needed when someone claims medical causation in the courts as well – that a medical act, device, drug etc. caused harm – with very narrow exceptions).

Continue reading “Vaccine injury compensation and autoimmune syndromes”

Nine vaccine questions from an anti-vaccine activist

vaccine questions

Some of you may remember the nine vaccine questions from anti vaccine activists answered so capably by Dr. Mark Crislip. Apparently, anti-vaccine activist Lowell Hubbs (who spends a lot of time trolling the comments section of this website) came up with his own set of nine new vaccine questions – which have no more validity than the original nine. In a post titled “9 Questions For The Pro-Vaxers” – to which I would rather not link here, but if you come across it, you will recognize it (we decided that few the thousand readers of this post shouldn’t have any incentive to click on a link to his website).

Let’s take a look at Hubbs’ nine vaccine questions, and provide the appropriate answers.

Continue reading “Nine vaccine questions from an anti-vaccine activist”

Aluminum adjuvant in vaccines – let’s go cherry picking

Aluminum adjuvant

With the success of California’s vaccination law, SB277, there appears to be a trend to increase vaccination uptake among school-aged children. And it’s a great thing that we protect our children from vaccine preventable diseases. Yet, the anti-vaccine crowd is still looking for lame excuses to not vaccinate – today, it’s the aluminum adjuvant in vaccines.

The anti-vaccine crowd has a tendency to ignore the vast and powerful scientific consensus on vaccines. Instead, they prefer to cherry pick research, often from biased “scientists” who publish in the lowest quality journals. That cherry picking is a form of confirmation bias – the individual seeks evidence that supports their a priori conclusions rather than letting the robust body of evidence point them to a conclusion.

Generally, these myths, based on cherry picking, are debunked. But the anti-vaccine cult is nothing if not creative. They just move on to a new boogeyman. This time, it’s aluminum adjuvants in vaccines. To be honest, anti-vaccine tropes are zombies, so we think we destroy those tropes, but they rise again, fed by new cherry picking. And debunking the danger of aluminum in vaccines has been an age-old discussion amongst the pro-science crowd.

Today, we’re going to look at one of those articles which was recently published. If one accepted this research, while ignoring critical analysis and the body of other science, then it would be a great one to confirm one’s own pre-conceived beliefs. But that’s not how we do science, so let’s take a look. Continue reading “Aluminum adjuvant in vaccines – let’s go cherry picking”

Antivaccine lies–peanut oil and vaccines

The lying liars who lie, also known as antivaccine websites, have one goal in mind: say anything about anything that makes it appear that vaccines are dangerous, repeat it over and over, and then hope that other websites pick it up. Eventually, some people will think it’s a fact, and when you Google this “fact,” there will be so many websites that repeat the same lie (and some innocently, without really critically analyzing it), even a somewhat impartial observer will think that it’s the TRUTH.

About as close as peanuts will come to vaccines.
About as close as peanuts will come to vaccines.

Now, they can’t make obnoxiously obvious lies, because there are lines that one can’t cross before everyone can see it’s a lie or the product of insanity. If an antivaccine website says that aliens from Klingon manufacture the vaccines so that humans will grow a ridge on their forehead, well that would be ridiculous. Cool, but ridiculous. Yes, I know there would be some small number of people who say, “I knew it!”  Continue reading “Antivaccine lies–peanut oil and vaccines”

Pandemic flu vaccine and narcolepsy–an analysis

H1N1 vaccineToday, the British Medical Journal published a retrospective study, by Elizabeth Miller, that analyzes the risk of narcolepsy in children and adolescents in England who received the 2009 A/H1N1 pandemic flu vaccine (Pandemrix) from October 2009 through mid-2010. This study followed up on the observations seen in Finland and other countries that there was some increased risk of narcolepsy in children a few months after receiving the vaccine.

As background, narcolepsy is a chronic neurological disorder caused by the brain’s inability to regulate sleep-wake cycles normally. Individuals with narcolepsy often experience daytime sleep patterns, but the disorder should not be confused with insomnia. It is not caused by a mental illness or psychological problems. It is most likely affected by a number of genetic mutations and abnormalities that affect specific biologic factors in the brain, combined with an environmental trigger during the brain’s development, such as a virus. It may also be a result of an autoimmune disorder. At this time, there is no cure for narcolepsy, but it can be successfully treated by medications and other therapies.

Roughly 70% of individuals who have narcolepsy have a comorbidity of cataplexy,  a sudden and transient episode of loss of muscle tone, often triggered by strong emotions.  Continue reading “Pandemic flu vaccine and narcolepsy–an analysis”

Logical fallacies Part 1-Anti-vaccination gang’s naturalistic fallacy

In this blog, the term “logical fallacy” is used frequently to illustrate a logical or rational failure of a particular argument. There are several definitions of what constitutes a logical fallacy:

[pullquote]❝A logical fallacy is, roughly speaking, an error of reasoning. When someone adopts a position, or tries to persuade someone else to adopt a position, based on a bad piece of reasoning, they commit a fallacy.❞–Logical Fallacies[/pullquote]

[pullquote]❝An argument that sometimes fools human reasoning, but is not logically valid.❞–Fallacious Argument[/pullquote]

[pullquote]❝In logic and rhetoric, a fallacy is usually an improper argumentation in reasoning resulting in a misconception or presumption. By accident or design, fallacies may exploit emotional triggers in the listener or interlocutor (appeal to emotion), or take advantage of social relationships between people (e.g. argument from authority). Fallacious arguments are often structured using rhetorical patterns that obscure any logical argument.❞–Wikipedia[/pullquote] Continue reading “Logical fallacies Part 1-Anti-vaccination gang’s naturalistic fallacy”