I must admit that last week, when I saw the study that I’m about to discuss, I basically laughed it off and decided to let it go. It was just that ridiculous. Over the years, I’ve read a whole lot of vaccine studies, some excellent, some good, and a whole lot of truly awful. Naturally, invariably the last of those categories, the truly execrable studies, the ones I like to refer to as “dumpster diving,” the ones people like Mary Holland, Christopher Shaw, Christopher Exley, or Mark and David Geier (and more others than I can remember) or cited by antivaccine activists like Kelly Brogan, Robert F. Kennedy, Jr., or J.B. Handley. To give you an idea, I’ve seen lots of vaccine studies seeking to demonize vaccine involving animals, such as monkeys, mice, and rats. I’ve never one that used sheep. It’s almost enough to make me want to yell, “Wake up, sheeple!”
Then I saw that antivaccine pediatrician Dr. Bob Sears had picked up on Robert F. Kennedy, Jr.’s credulous promotion of this study on his Children’s Health Defense website:
In fairness, “Dr. Bob” seemed a bit puzzled by the study and unsure of it. The same can’t be said of Celeste McGovern’s treatment of it on RFK Jr.’s website, entitled Vaccines Induce Bizarre Anti-Social Behaviour in Sheep:
Just seven injections of vaccines or the aluminum salt added to vaccines caused alarming behavioral changes linked to a fatal nervous system disorder in sheep, a new study from Spanish veterinary researchers shows.
Vaccinated lambs and lambs that received injections of aluminum that is used in human vaccines as well, began aggressively biting the wool from other sheep, pacing restlessly and overeating, according to the study published this week in the journal Pharmacological Research.
Upon reading this paper, the first question that popped into my mind was “WTF?” The second question was: Why sheep, and what were these scientists trying to prove? Before I get into that, however, who are these scientists? They’re a bunch of animal scientists from the University of Zaragoza, Spain. It’s a university that I’ve never heard of. Who they are matters less than the quality of the science, which is not that great.
So let’s move on. First of all, you need to know what the ASIA syndrome is. ASIA stands for Autoimmune/inflammatory Syndrome Induced by Adjuvants, and it’s a basically nonexistent syndrome peddled by an Israeli immunologist named Yehuda Shoenfeld (who’s been known to have papers retracted). Its definition is so vague that it can mean almost anything antivaxers want it to be. It’s described in the introduction to this paper after a recounting of how, after vaccination against bluetongue (BT), a serious viral disease of sheep, a previously undescribed syndrome was reported involving severe neurological symptoms with lesions of sterile meningitis, followed by a chronic phase that involved extreme weight loss and neurodegenerative changes in the spinal court.
All known ovine diseases were ruled out as a cause of the syndrome, and it was concluded that the process was associated with the use of Al-adjuvant containing vaccines, and has been included under the umbrella of the Autoimmune/inflammatory Syndrome Induced by Adjuvants (ASIA syndrome) [21,22]. In the chronic phase, sheep exhibited a variety of behavioral changes including periods of depression (i. e., lack of response to stimuli, stupor) and lethargy intermixed with periods of excitement, restlessness, polyphagia, and increased aggressiveness, especially compulsive wool biting between animals. Some of those behavioral changes were reproduced in a small cohort of repeatedly vaccinated lambs, but they were not fully characterized . Similar behavioral changes have been observed in experimental laboratory animals that were inoculated with Al adjuvants .
I have no idea if these scientists are antivaxers, but they do clearly believe in the existence of ASIA, even though the evidence is overwhelming that the syndrome, whether it exists or not, has nothing to do with vaccines. Indeed, the existence of ASIA is not accepted by the vast majority of scientists and regulatory agencies for good reason. There are large studies that have failed to link aluminum adjuvants with autoimmune syndromes. Of course, these are veterinary scientists; so maybe there is such a syndrome in sheep. Whether it has anything to do with humans is pretty darned unlikely, though, given that we already have large epidemiological studies. Still, let’s see what the antivaccine propaganda version of the story is:
The experiment was part of a research effort to understand a mysterious new disease that had decimated the Spanish sheep industry between 2008 and 2010 following a government-mandated bluetongue vaccine campaign.
Prof. Luján was approached by farmers at the time who were losing entire flocks to the disease. Animals were affected in two phases: in the first acute phase, only a few animals in a flock became nearly unresponsive with an acute meningoencephalitis, and a second chronic phase, sometimes months later and frequently triggered by an exposure to cold weather, affected up to 100 percent of flocks. The sheep became restless and anxious, then showed extreme weight loss and neurological damage. Eventually, all four limbs were paralyzed and they dropped to their front quarters, comatose, and died.
The disease was reproduced experimentally by repetitive vaccination of sheep. Post mortem exams revealed the animals’ nervous tissue was riddled with the toxic metal aluminum.
This was a relatively small study, with two parts. The first part involved only 64 sheep selected and 23 flocks either before or after the compulsory vaccination against bluetongue in 2008 in which the authors reported that the “ASIA syndrom” acute phase was observed in 25% of the flocks they examined and affected only 0.5% of the animals in a given flock. The The second part involved a ridiculously small number of animals, three in each experimental group, with the vaccinated group receiving a ridiculously high number of vaccinations, a total of 1 in 198 days with 4 mg aluminum adjuvant per vaccine. The statistics were dubious. The animals were reported to have behavioral issues, but it sure sounded ot me as though investigators were fishing for results in the postmortem examination and histological examination of the tissues. Nothing impressive was reported.
So what about the current study? Here’s what the investigators did:
The study was carried out at the experimental research farm of the University of Zaragoza. Twenty-one unvaccinated, neutered, male purebred Rasa Aragonesa lambs were selected at 3 months of age from a pedigree flock of certified good health and assigned to one of three groups of seven animals each. Group A (Control) was inoculated with PBS, Group B (Adjuvant-only) was inoculated with the adjuvant only, and Group C (Vaccine) was inoculated with commercial vaccines that contained Al as adjuvant. The experiment ran from Feb 2015 to Feb 2016 (349 days), which included a full summer and a winter period.
Now here’s the rub:
Lambs underwent an accelerated vaccination schedule, designed to inoculate -within an acceptable experimental time frame- an Al load equivalent to that a sheep under local management field conditions usually receives along 6-7 years. Animals in Group C (Vaccine) were inoculated with commercial vaccines against main ovine diseases (Table 1, Fig. 1), receiving 16 vaccine doses within 12 months and a total of 70.861 mg of Al. The recommended application procedures for each product were always followed. Animals in Group B (Adjuvant-only) were inoculated with Al-hydroxide only (Alhydrogel®, CZ Veterinaria, Spain), at concentrations that were identical to those of the corresponding commercial vaccine, measured by inductively coupled plasma atomic emission spectrometry (Table 1). Group A was inoculated with an identical volume of PBS. All inoculations were performed in the subcutaneous tissue of the area encompassing scapula and ribs, using individual, sterile disposable syringe and needle for each injection.
The animals were subjected to behavioral assessments, including a T-maze, open field test, and the novel object test. They were also subjected to other behavioral tests designed to demonstrate social behaviors. It’s not critical to know exactly how these tests are carried out, but in each case videotapes of the animals undergoing the test were evaluated by observers blinded to experimental group. And there was a hell of a lot of video to examine, many hours of recordings.
Here are the results: There were no real differences in the cognitive tests, including the T-maze, open field test, and novel object test carried out in summer and winter. For example:
In the OFT in winter, Group B lambs spent significantly (pW = 0.043) more time exploring than they did in summer and Group C lambs spent significantly (pt = 0.003) less time trying to escape (Fig. 2). In the NOT, in winter, Group B lambs were significantly (pW = 0.043) farther from the novel object in the second exposure than they were in the first exposure (Supplementary Tables S12 – S19).
What does this even mean? There’s no consistency. Remember, group B is the adjuvant-only group, and group C is the vaccine group. So in one test the group B sheep were barely statistically significantly different in while in another test the group C sheep spent more time trying to escape. As far as behavioral tests, the authors reported that sheep in groups B and C spent less time lying down and were more prone to restless pacing and random repetitive behaviors compared to controls. The authors concluded that this is an indication of stress but also that the animals were not housed in stressful conditions, meaning that it must be the adjuvant or vaccines causing these behavioral changes.
Overall, there are a lot of problems with this study. First, it’s not randomized, something that would really be needed to try to prevent any systematic difference in group assignments for sheep. A huge problem, again, is that the authors intentionally tried to accelerate the vaccine schedule for sheep, compressing seven years’ worth of vaccines into a year. Also, although the investigators making the behavioral measurements were blinded, the study was not double-blinded, and the authors relied on observations of the sheep’s behavior with a large subjective component. Given how small the number of animals was, I find it hard to take the results seriously at all. Although some tests use ANOVA and appropriate correction for multiple comparisons, others appear not to, and I have a hard time telling which tests did and did not undergo appropriate statistical analysis. There are also a bunch of t-test comparisons between groups and multiple measures datewise comparisons, but no mention of how many tests turned out to be statistically insignificant. Indeed, as a rule of thumb, if your number of outcomes assessed is greater than the number of subjects in each experimental group, your experiment is poorly designed and statistically dubious.
That’s not all. Prof. Lluís Luján has co-authored at least one paper with Yehuda Shoenfeld on ASIA. Even worse, Christopher Exley, who is, as I like to say, a rising star in the antivaccine movement due to his obsession with aluminum as the cause of autism and other neurological conditions, co-authored one of Luján’s sheep papers.
So, basically, what we have here is yet another in a string of animal models for ASIA in which animals are subjected to treatments that have no resemblance to reality and possibly overdosed on aluminum, lots of comparisons are made on small numbers, and conclusions not justified by the results trumpeted by the authors and picked up by antivaccine sycophantic groups like RFK Jr.’s Children’s Health Defense as evidence of how dangerous vaccines are. Same as it ever was. Crap science begets bogus conclusions.