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

Dr Bob Sears medical license on probation resulting from his anti-vaccine views

Dr Bob Sears

On 27 June 2018, Dr Robert (Bob) Sears, an anti-vaccine pediatrician, agreed to a stipulation with the California Medical Board that put his license to practice on probation and subjected him to a set of non-trivial conditions. The revocation of the medical license of Dr Bob Sears was stayed by the Medical Board – it will not become operative unless he violates the conditions – but given the specific allegations in the complaint and the fact that this was his first disciplinary action, an immediate full revocation was not likely. The sanction is non-trivial, and a clear warning against future misconduct.  Continue reading “Dr Bob Sears medical license on probation resulting from his anti-vaccine views”

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”

Bob Sears’ personal attacks on Paul Offit – anti-vaccine evidence

bob sears

On March 13, 2015 Dr. Bob Sears, a California antivaccine physician, wrote a post on Facebook attacking Dr. Paul Offit, pediatrician, vaccine inventor, scientist, vaccine advocate and educator.

Dr. Sears wrote:

A FAILED ATTEMPT TO CHANGE HIS NAME FROM DR. PROFIT TO DR. PROPHET

Everyone’s favorite infectious disease doctor tried to write a compelling argument as to why parents should not have religious freedom to decline vaccines, and the New York Times shot it down. Here’s a link to the Time’s review. So, sorry to help publicize this waste of trees, but the more people who know that this vaccine advocate doesn’t care about religious freedom in the United States the better. Enjoy!
Dr. Bob.

sears-facebook-1 Continue reading “Bob Sears’ personal attacks on Paul Offit – anti-vaccine evidence”

Index of articles by Prof. Dorit Rubinstein Reiss

Dorit Rubinstein Reiss

Editor’s note – this index of articles by Dorit Rubinstein Reiss has been updated and published here. The comments here are closed, and you can comment at the new article. 

 

Dorit Rubinstein Reiss – Professor of Law at the University of California Hastings College of the Law (San Francisco, CA) – is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines (generally, but sometimes moving to other areas of medicine), social policy and the law. Her articles usually unwind the complexities of legal issues with vaccinations and legal policies, such as mandatory vaccination and exemptions, with facts and citations. I know a lot of writers out there will link to one of her articles here as a sort of primary source to tear down a bogus antivaccine message.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination–she really is a well-published expert in this area of vaccine policy, and doesn’t stand on the pulpit with a veneer of Argument from Authority, but is actually an authority. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

Below is a list of articles that Dorit Rubinstein Reiss has written for this blog, organized into some arbitrary and somewhat broad categories for easy reference. Of course, she has written articles about vaccines and legal issues in other locations, which I intend to link here at a later date. This article will be updated as new articles from Dorit are added here.

Continue reading “Index of articles by Prof. Dorit Rubinstein Reiss”

Your one stop shop for the anti-vaccine hate debate

vaccine hate debate

I and others have written several articles on this website about the anti-vaccine hate debate – discussing the atrocious and hateful behavior of a large portion of the anti vaccination cult.

This kind of “free speech” goes beyond simple mockery, ad hominem attacks, or, though it rarely happens, arguments about the science. Ad hominem attacks are, by definition, personal attacks that are used in lieu of real evidence. So, if you lack evidence to support your side of a debate (even a fake debate like what is happening with vaccines), you attack the person, rather than the evidence.

Of course, if you do lack evidence, you will be mocked mercilessly for lacking said evidence. Cherry-picked evidence doesn’t count. Appeals to authority as evidence doesn’t count. Employing the Nirvana fallacy doesn’t count. The only evidence that matters must come from high quality sources that are repeated many times and are often rolled up into a substantial meta-review.

The vaccine hate debate on exists because they have nothing – no evidence of harm, no evidence of a lack of benefit. None. Ground zero of the Facebook anti-vaccine hate crazies is The Vaccine Resistance Movement (VRM) – read their hatred and lies. Donald Trump would be proud of them.

Continue reading “Your one stop shop for the anti-vaccine hate debate”

Antiscience Donald Trump elected President – man the science barricades

antiscience donald trump doesn't know science

I disappeared for a few days after the election of a man who espoused racism, xenophobia and misogyny as the reasons to vote for him. His actual policy proposals were threadbare and, if he really believed them, we are looking a historical dismantling of all that is special about the USA. It’s hard to choose what scares me most about this sexual predator’s policies, but the antiscience Donald Trump ranks pretty much at or near the top.

Generally, the Republican party is quite antiscience. Republicans deny climate change. Republicans deny evolution, while Trump’s running mate, Mike Pence, is hypercritical of evolution. And of course, Republicans have shown themselves to be vaccine deniers. There’s a lot more, but many of us consider those topics to be in the top 5 list of science denial. Frankly, if someone said that Trump believed in alien visitations and Sasquatch, and he was sending tax money to investigate them thoroughly, I wouldn’t be surprised.

On a broader level, a Trump administration will probably gut science research by cutting funding to National Institutes of Health and NASA programs in basic scientific research. There are probably areas, where Trump will appoint directors who are opposed to the years of science that form a basis of policy.

Despite the press tacitly being in bed with Trump, never really investigating him, Hillary Clinton won the election based on the popular vote, with a several hundred thousand vote lead over Trump. I think most Americans wanted a President who supported science. Sadly, Trump won the election because the USA uses an antiquated and anachronistic method to actually choose the president. A method that is based on needs of 250 years ago and on the negotiations required to get slave holding states to agree to the new Union. But, I’m not a political scientist, and the arguments for and against the Electoral College system of voting would be far beyond what are topics for this website.

Let’s just look at the antiscience Donald Trump, sticking to the key issues of climate change, evolution, and vaccines.

Continue reading “Antiscience Donald Trump elected President – man the science barricades”

Vaccines and autism – conflicts of interest in research

Conflicts of interest in research is one of the fundamental tropes of people who seek to diminish the value of biomedical research, even if the research is peer-reviewed and is published in a highly respected journal.

The vaccine deniers try to dismiss all medical research that has even the appearance of conflict of interest.

From my point of view – yes, we should examine research with a conflict of interest, especially in medical research, more carefully. But, as I’ve said a hundred times, it’s not one article that matters, it’s the body of work. Science is based on evidence that is analyzed, critiqued and, most importantly, repeated – repeatedly.

In the world of vaccines (including that annoying and loud anti-vaccine fringe group), one of the recurrent themes is that immunizations cause autism, and any research that disputes that belief is biased and/or supported by Big Pharma. That is the definition of conflicts of interest in research – this is repeated so often, sometimes I believe it.

But then I get back to reality and know that the scientific consensus, repeatedly repeated, supports the fact that there is no evidence that autism is related to vaccines or is caused by vaccines.  Continue reading “Vaccines and autism – conflicts of interest in research”

Anti Semitic hate speech of the antivaccine cult

I think I’ve said this close to a million times (give or take a few hundred thousand) – the only thing in science that matters is evidence. That’s it.

It’s been clear to me for a long time once those one the anti-science side realize they lack evidence, they go for the ad hominem attacks, in all kinds of forms from accusing people of being shills for whatever company to going full-Godwin, that is, if you wait long enough while in an internet discussion, someone will claim something or someone is a Nazi.

Well, the anti vaccine cult has reached a new high (or is it low) for breaching Godwin’s Law, bypassing a lame relationship between vaccines and Nazis, and going straight for anti Semitic hate speech and bigotry.

Continue reading “Anti Semitic hate speech of the antivaccine cult”

Abuse of California’s vaccine personal belief exemptions

If you have been following the news, or even this blog, you probably are aware of SB 277, a bill sailing through the California legislature which, upon enactment, will essentially eliminate the California vaccine personal belief exemptions (PBE) to vaccinations of children entering in public schools or day care centers.

One of the favorite tools of the vaccine deniers is a personal belief exemption that allows them to essentially refuse to vaccinate one’s child based something other than a valid medical contraindication to vaccinate a particular child. These exemptions, at least in California, can be for almost anything, including the nonsense “religious exemption.” Ironically, it’s difficult to find a real mainstream or even non-mainstream religion that is opposed to vaccinations.

Court case after court case has supported vaccination of children and has generally rejected many attempts at using religious exemptions to refuse vaccinations. So California, which has experienced some measles outbreaks because of unvaccinated children, has decided to get tougher on vaccinating their children, and eliminate California.

Continue reading “Abuse of California’s vaccine personal belief exemptions”