Last updated on April 5th, 2018 at 02:12 pm
This year I got a special birthday gift; someone sent me a piece about vaccine aluminum toxicity written by the noted anti-vaccine activist, J B Handley. In part, it reads:
While you were (hopefully) enjoying the winter holidays, a study was published in the Journal of Inorganic Biochemistry (it went online on December 27th) that could change the autism debate permanently.
I’d actually already been alerted to the paper, which is linked here. Some blogs of which I am a fan do a tl;dr (too long; didn’t read) summary at the end. I’m going to break with this and do it at the start.
This paper by several authors, including the anti-vaccine Christopher Exley and Romain K Gherardi, published in the Journal of Inorganic Biochemistry (which has been a subject of this blog before) has one of the worst introductions I have ever read. The first paragraph is basically copy/pasted from others and then twisted to fulfill the anti-vaccine tone of the paper. From there on in it doesn’t get any better.
Many of the references don’t say what the authors want you to think they do. Genuinely, the authors introduce papers which conclude that there is a lack of evidence for causality, but the authors act as if they conclude the opposite.
Many other references are items by the authors – the self reference is rampant. They, apparently and willfully, misrepresent the current state of play regarding the EMA and certain members of the Nordic Cochrane group –it is almost unbelievably poor.
Time to take a look at this paper in detail.
About that aluminum toxicity paper – first sentence
Since, according to Handley, this is a paper of such import I thought I’d go through it carefully. I thought, that since it was my birthday, I’d indulge my own idiosyncratic approach and start with the introduction and check the references as I went along. I realise (see Note 1) this isn’t the way most people tackle a paper, but I find it a useful way to gauge the general timbre of a piece.
So I started…
The first sentence struck me, even on my first reading, as bizarre. I realise the paper itself was originally written in French, and that scientific papers aren’t always known for their polished style, but surely this seems odd?
Vaccination helped with the eradication of smallpox, a 99% decline in poliomyelitis between 1988 and 2003, and a 40% decrease in measles cases between 1999 and 2003 worldwide, as well as a decrease in cases of mumps of 859 to 9 per 100,000 inhabitants between 1986 and 2013 in France [1].
“Vaccination helped”? With the eradication of smallpox; that’s damning with faint praise? Then the figures for polio and measles only up to 2003? Why not use more recent figures? The polio decline is now >99% and measles cases for 2016 were down to 89,780 (the first year global deaths fell below 100,000) which is an almost 90% reduction from 1999. Also the sudden jump to specific French incidence figures for mumps?
To be honest I wasn’t sure how the sentence came to be constructed in such a way. So I checked the reference. It’s a webpage in French, and roughly translated it reads:
According to the World Health Organization, vaccinations save the lives of 2 million people every year worldwide. International campaigns have led to the eradication of smallpox, a 99% decrease in polio cases between 1988 and 2003, a 40% decrease in measles cases between 1999 and 2003. In France, thanks to the vaccine, the incidence mumps decreased from 859 to 9 cases per 100,000 population between 1986 and 2013.
There’s using a reference and there’s straight up copy/pasting and adding a certain slant?
About that aluminum toxicity paper – second sentence
That first sentence wasn’t getting me off to a good start. The second sentence, likewise, seemed very clunky. Referring to observed resurgences of pertussis and rubella, but not giving any context.
The maintenance of a good vaccination coverage, i.e. a high rate of vaccinated person in the population, is necessary to avoid the resurgence of other infectious diseases as was observed for pertussis or rubella, with a double benefit, both individually and collectively, by reducing the number of people who can transmit infectious disease [1].
Again, looking at reference [1] provided an explanation:
But diseases continue to rage around the world while vaccines exist: Pertussis has resurfaced in the United States, especially in California, since 2011. Rubella is prevalent in Eastern Europe, particularly in Poland and Romania. since 2012. Between 2008 and 2013, measles has reappeared in force in Western Europe, particularly in Germany and eastern France. Only the maintenance of good immunization coverage, that is to say a high rate of vaccinated people in the population, makes it possible to keep these diseases at bay…
To say that I detect a faint hint of bias in the way they’re framing the situation would be an understatement.
About that aluminum toxicity paper – more
But let’s move on… The next sentence acknowledges the success of ‘many vaccines’ but then leads straight to claims of a “growing public distrust of vaccination in recent years”? This isn’t referenced? I think we are all aware of the existence of some public distrust, but how much it has grown and how recently this has been a phenomenon is possibly worth evidencing if you’re going to make such a claim?
They then segue into the scale of the global dollar value of the vaccine market. Which seems a bit of a non-sequitur? I’m glad that there are new vaccines being researched, and that the WHO is supporting global vaccination programmes. They quote several figures in one sentence here:
- More than 120 vaccines being developed
- An annual growth of 20%
- Turnover (see Note 2) increased from 5 to 43 billion dollars between 2000 and 2016
- Turnover >100 billion in 2025
These numbers are referenced in [2], which is a 2012 WHO document (pdf). The 120 products in the pipeline and the >$100 billion figures are indeed on slide 15.
I found reference to the growth of 10-15%, but not 20%. The figures from a 2012 document unsurprisingly don’t encompass 2016 figures either. Perhaps they used a different source for these latter figures? I am still not certain what purpose they serve in the context.
That’s the first couple of paragraphs. The next one again frames the situation, declaring vaccines to be “a major societal issue” and then listing several factors contributing to “mistrust of vaccination”. These factors are all referenced as quoted directly from reference [3], which is this website.
Reading the page, which reports on Alain Fischer’s consultation in 2016, firstly we identify the source of the claim of “growing public distrust”, as these words come straight from here: “In spite of unanimity of the juries of citizens and experts which stress the importance of vaccination as a tool for the prevention of infectious diseases, the report underlines a growing mistrust of the population with regard to vaccination.”
It should be noted that this distrust is framed as being counter to the opinion of experts and also that it is a distrust due to several issues which are specific to France. The paper then presents the list of “factors”, including ‘Mediator, contaminated blood, etc.”.
I hate to admit to such ignorance, but prior to reading this paper, I was unaware of the Mediator drug scandal. I was aware of the contaminated blood scandal, but only vaguely. The way the list is presented in this paper is strange when the paper is taken in context as one to be read by an international audience.
Are we to assume the paper itself relates solely to concerns about vaccines specific to France? Is it just…lazy? It’s also removing the context of the list to quote it in full without mentioning in the conclusion of Fischer’s report, which was that: “in the current context of mistrust, he advocates instead to expand, temporarily, the list of mandatory vaccines for the child. This measure should be accompanied by full coverage of the cost of purchasing vaccines by health insurance.”
I would add here that the extent of copy-pasting so far in this paper is, in my opinion, excessive.
The paper then confidently asserts that a “key question” in the debate on vaccine safety concerns adjuvants. The issues of adjuvants are indeed raised by Fischer, but is one of several. The reference given for this claim is in fact reference [4], Bégué et al. By now I was clearly going to check what Bégué et al’s position on adjuvants actually was; they conclude:
The detailed analysis of the conditions required to provoke an autoimmune disease provides no evidence to date to incriminate vaccines or adjuvants. Any moratorium on the non-use of aluminum adjuvants would make impossible, without any convincing argument, the majority of vaccinations. The resurgence of diseases prevented by these vaccines would, on the other hand, certainly lead to a morbidity much higher than that, hypothetically, of autoimmune or neurological diseases attributed to vaccination.
So they are citing a report which concludes that there is no evidence adjuvants cause autoimmune disease. This as evidence of a “controversy”?
The next reference is to a book published in 1926, somewhat reluctantly I am going to take them at their words that it “empirically introduces” aluminium (see Note 1) salts as adjuvants.
Onwards, as they say, and upwards. The next sentence begins:
“It [presumably ‘the controversy’] has resulted in various actions being brought by patients associations…”
Here they provide links to two websites as their references, [6] and [7].
Now then, I’m not French so I asked for a one-sentence impression of these sites from a scientist friend whose first language is French.
From the first website:
Vous visitez ce site pour en savoir plus sur notre maladie ? Nous espérons vous apporter les informations que vous attendez et peut-être vous donner l’envie de rejoindre le combat que nous menons. Avec cette précision : nous n’agissons pas CONTRE LA VACCINATION, mais POUR DES VACCINS SANS ALUMINIUM.
As my French friend said, “that last sentence? It’s like people who say, ‘I’m not a racist, but…'”
Of the second one, they were even more damning, “you can say this association is kind of the NVIC for HepB….”
Exley, Gherardi et al. next cite a couple of books, one by (and this may become a bit of theme) none other than Gherardi, titled “Toxic Story“. Next, they refer to “scientific blogs”, but I think they’ve actually got an issue with their references here as reference [10] is actually Vaccine Papers.
I jest; but genuinely? Including the Vaccine Papers website as a reference, other than as an example of a rampantly anti-vaccine website?
Next up they cite some “institutional technical reports”. The first being reference [4], which as we have already seen concluded that there was no evidence that adjuvants cause autoimmune disease. Then there are references [11-15]. These are again in French, again I have friends who speak French as their first language whose impressions I have sought, but don’t yet have in full (I am actually proud of my Huguenot heritage, but it doesn’t stretch to reading French technical reports). I would, were I peer reviewing this article, note that the use of French language references can be less than helpful for an international audience.
All about aluminum toxicity
But moving on… The authors of the paper then contend that “the exact degree of safety of aluminium-containing vaccines has remained the subject of persistent disagreement”. Really? Just from reading their references from this introduction I’d say that isn’t a fair description. But they then wish to expand; and claim that “The occurrence of myalgia and arthralgia, chronic fatigue, and neurological disorders following multiple injections of aluminium-containing vaccines against hepatitis B, tetanus and human papillomavirus (HPV) has been reported on many countries.” (See Note 3)
Which is actually where my real issues with this paper start (bearing in mind we have found that they basically plagiarised and “anti-vaxxed up” their first paragraph and have utterly misrepresented Bégué…).
So, they cite seventeen references to support this claim. Shall we have a look at some of them? Remember they wish to concentrate on the aluminium-containing aspect of the vaccines.
First up is reference number [16]. This is Richards on the subject of complex regional pain syndrome (CRPS). And what does the actual Richards et al paper say? They propose that “…it is the process of a needle penetrating the skin that is the trigger, rather than a particular vaccine antigen or adjuvant being causally related.” (See Note 4)
So, an interesting choice for their first reference.
Next up is reference [17]. This is the report of a working group set up to look at a possible relationship between HepB and CFS. What did they conclude?
Members of the working group felt that there was no evidence linking hepatitis B vaccine administration with the appearance of CFS.
That research group provided a list of arguments; arguments against any causative link. I’m not asking you to trust me on this. The references are available. The first two that they cite indicate no causative link.
Clearly, after this rather astounding start, things were going to get a little less exciting and the next reference is [18]. This is a funny little paper, describing four cases of CRPS linked to HepB vaccine. We’ve already seen that Richards et al. reckon CRPS and vaccination are probably if linked at all, linked due to the very local trauma rather than adjuvants. But it’s nonetheless a fascinating little case series if it can be called that. I was especially impressed with the notion that CRPS can resolve within hours or days? I’m no expert on CRPS, perhaps someone reading this who is might have some feedback?
Moving ever onwards, though, the next two references are to the work of L. Brinth. Now, if you read onwards you’ll see that dedicate much of page 5 to the activities of certain individuals associated with the Nordic Cochrane group.
I suppose it’s fair for me to interject some details about that here. Back in 2015, the EMA published a report, which considered the evidence for a causative link between HPV vaccines and postural orthostatic tachycardia syndrome (POTS) or CRPS (See Note 5).
Exley, Gherardi et al. cite this as their reference [36]. The report considered several studies mentioned this paper by Exley, Gherardi et al. (including Brinth’s), and also clinical trial data. On page five of this paper, the authors are highly dismissive of the EMA report, for example regarding the clinical trial data analysis. In the clinical trials various controls were used, several of which contained aluminium adjuvants.
The authors of this paper declare that “despite this major bias” [35, Exley self-citation, natch] “European Medicines Agency (EMA) issued a negative opinion on an association between HPV and increasing of adverse effects”. Well, yes they did. They have been challenged about their approach to this data, and are confident in defending their position including when this was discussed with the European Ombudsman (see below).
They went into some detail about why they felt specifically that CRPS and POTS were not causatively linked to the HPV vaccine. This detail included commentary on Brinth’s papers. Their comments here resulted in a response from Brinth which the author herself suggested many might find “strange, maybe even ridiculous”:
As the Exley & Gherardi article under discussion here describes it “Cochrane Nordic” (see explanation below) also responded and later lodged a complaint against the EMA with the European Ombudsman. I put “Cochrane Nordic” in quotes for a reason, the complaint has a disclaimer to the effect that it is from the authors, and not of any organisation:
So what of this complaint, made back in October 2016? The Exley & Ghererdi article I’m discussing here was revised in December 2017. Surely that was time enough for them to add a note about the outcome of the European Ombudsman’s investigation into the complaint? The decision came in October 2017 and was:
There was no maladministration by the European Medicines Agency in the handling of the referral procedure on the HPV vaccines.
It can be found here, and is mercifully succinct.
The way this entire scenario is represented in the paper is at best disingenuous and at worst deliberately misleading. The EMA found there to be no causative link between the HPV vaccine and CRPS and POTS. Some individuals, some of whom were affiliated with the Nordic Cochrane, took issue with this. The conclusion from the EMA stands, and the Ombudsman found the EMA not to be guilty of any maladministration.
Some of this palaver was described in this piece.
The piece above pre-dates the Ombudsman complaint and decision but refers to the situation leading up to it. To cut a long and complex story short – I am not going into Brinth’s papers, instead, I’d suggest reading the EMA report.
Next up is reference number [21], which is a self-reference from Gherardi. Reference [22] likewise is by Gherardi.
Perhaps at this point returning to the jumping off point of this, which was, of course, Hundley’s piece, is useful. He also says in his article that:
At great potential cost to their careers, it appears that six scientists — none American — have stepped forward to sound the alarm loudly about the extreme danger of aluminum, and perhaps initiate a reckoning of the true cause of the autism epidemic once and for all. Dr. Chris Exley of Keele University; Drs. Romain Gherardi and Guillemette Crepea of Université Paris Est Créteil; Drs. Christopher Shaw and Lucija Tomljenovic of the University of British Columbia; and Dr. Yehuda Shoenfeld of Tel Aviv University…
Now it’s Exley, Gherardi, and Crépeaux (I am not sure why Hundley truncated Crépeaux?). Perhaps he panicked when he couldn’t generate an acute accent?) are all co-authors of this paper. So that half of his “Big Six” right here. If this paper is indicative of the sort of quality of work they’re presenting then I for one am unconvinced.
Next up, aluminum toxicity causes diseases
Reference [23] isn’t by Gherardi. But it’s a paper which aims to determine the presence of oxidative stress in patients with macrophagic myofasciitis (MMF, see Note 6). The authors go on to describe MMF as an “unusual” inflammatory myopathy that was first described by Groupe d’études et de recherche sur les maladies musculaires acquises et dysimmunitaires (GERMMAD) and cites three papers in support of this unusual condition’s existence. You can probably guess the name of the key author of those three references. To give you a clue, it starts with G and the second letter is h…
Anyone curious about the validity of MMF as a condition might do well to check out the WHO/GACVS pages on the topic. To quote: “There is no evidence to suggest that MMF is a specific illness..”
But we will persist. At least a little further.
Reference [24] is another self-reference, this time an Exley paper. It’s one heck of a weird paper. Worth checking out, to be honest. It’s from Medical Hypotheses (see Note 7). It’s about a man with “aluminium overload” and seems to be part of an opportunity to promote some sort of “detox” mineral water. What it’s supposed to add to the general picture I am at a loss. Having now read a few Exley papers I do wonder if they do quality audits of the labs he works in – send some known control samples in for processing to see what levels of aluminium is found in them? It’s just a thought.
Reference [25] is one worth relishing for criticism. It’s a correspondence, and it outlines the onset of symptoms in the subject eleven (11) years post vaccination. Can I just repeat that? Eleven years. The references for this one are also pretty special, the first three being to Gherardi publications.
And so it continues.
Remember these are the references the authors of this piece picked. They had absolute freedom to pick whatever references they felt best supported their argument, their case. And they picked these?
Aluminum toxicity and ASIA
Reference [26] does actually refer to ill-effects following vaccination attributed to the vaccine adjuvants. Indeed it refers to ASIA, or autoimmune/inflammatory syndrome induced by adjuvants (see Note 8), which was “described” by Shoenfeld. Who was, of course, one of JBH’s “big six”. Now ASIA hasn’t exactly been embraced by the international community any more than MMF. As one widely respected blogger put it: “If you look at how ASIA is defined, it’s so vague that almost any immune abnormality can be so classified, as long as somewhere, somehow, the patient had exposure to an adjuvant…”
The next reference [27] is actually a Shoenfeld paper. It includes his traditional disclaimer “Prof. Yehuda Shoenfeld has served as an expert witness in cases involving adverse vaccine reactions in the no-fault U.S. National Vaccine Injury Compensation Program”.
Reference [28] is about a group of Japanese female adolescents. The symptoms they suffer are, let us say, a bit of a mish mash? Mostly the patients suffer from CRPS but also OH, POTS and OD. If you refer to the EMA report it’s quite clear that the current evidence is against a link between CRPS and POTS.
Reference [29] again refers to ASIA. But it’s a strange paper, referring to the discovery of epipharyngitis. Which isn’t a condition usually associated with vaccination. They were, they acknowledge, encouraged in their work by one Shoenfeld.
Reference [30] is really quite special. It’s a “questionnaire based study”; which I was startled by. I am glad to see that Helen Petousis-Harris wrote to the journal pointing out that the methodology (sending questionnaires to individuals identified via “anti-vaccination websites and blogs”) sets, to quote, “a very low bar for scientific enquiry”.
Helen Petousis-Harris’ full response to this paper is worth reading.
These are the references the authors of this paper chose; heaven alone knows which ones they discarded.
Reference [31] takes us back to the MMF, and is unusual for originating from Mexico rather than France. The dates between vaccination and onset of symptoms is quite…remarkable. Anything from 3 months to 16 years. Yes, sixteen years. Perhaps, to me, most fascinating is that 19% of their cases had no actual history of vaccination?
And finally they end this set of papers, which are intended to demonstrate to their readers that “the occurrence of myalgia and arthralgia, chronic fatigue and neurological disorders following multiple injections of aluminium-containing vaccines…have been reported in many countries”, with reference [32] which is about six patients with POTS published in 2014.
This paper was one of the several considered by the EMA in its review of the HPV and POTS. Actually, several of the references were considered by the EMA. The EMA report which concluded: “Overall, available data do not provide support for the causal relationship between HPV vaccines and POTS.”
The authors of the current paper are clearly aware of the EMA report, as they go into some detail even mentioning the involvement of the European Ombudsman (though neglecting to mention their conclusion that there was no maladministration at the EMA). The EMA report also considers the Brinth papers [19&20] and Kinoshita et al. [28].
But the authors wish to present the EMA report in a poor light. They wish their readers to instead focus on the “strong dissatisfaction” of certain scientists with the EMA’s conclusions. But they don’t provide the punchline, that of the European Ombudsman’s conclusion. This part of the paper includes their references [32] to [39].
Having attempted to discredit the EMA they declare that the “question of the existence of a causal link, and thus of an authentic adjuvant syndrome [40, 41], may never be resolved by epidemiological approaches [42].” No surprises to find that the authors of those first two references are Gherardi and Shoenfeld.
Reference [42] includes in its conclusion: “While there can be no such thing as a 100% risk-free vaccine, any risks of immediate severe adverse reactions are extremely low for modern vaccines and consumers should have high confidence in the safety of available vaccines.”
Its key points being:
Existing human adjuvants have a high level of safety. The relationship between specific adjuvants and rare adverse reactions such as narcolepsy or macrophagic myofasciitis remains to be resolved. More research is needed into adjuvants and how they work.
So yes, the paper agrees more research is needed, but it also stresses the high level of safety of existing adjuvants.
So all of these references it seems leads the authors of the paper to conclude that the performance of epidemiology to establish causality is notoriously limited. They therefore conclude that “the debate can be enlightened only by establishing the existence or not of an unequivocal biological plausibility of a causal link”.
Really? Beyond the questionable grammar of that sentence, what do they mean?
What was the point of all this? Didn’t they say: “The occurrence of myalgia and arthralgia, chronic fatigue and neurological disorders following multiple injections of aluminium-containing vaccines against hepatitis B, tetanus and human papilloma virus (HPV) has been reported on many countries:”
Are they now acknowledging that these reports aren’t showing what they appear to want them to show?
In the next sentence they then refer to the “well-established neurotoxicity of aluminium”. This is unreferenced; they refer to the neurotoxicity of “aluminium”? What sort of aluminium? Some compounds of aluminium are doubtless neurotoxins, but this unreferenced statement is just meaningless. Meaningless and scaremongering, simultaneously. Paracelsus must be rotating quietly somewhere.
They quote the WHO as referring to adjuvant safety as an “important and neglected field”, that’s reference [43]. This is a direct quote, but the context is referring to novel adjuvants and dates from 2004. The WHO position regarding aluminium adjuvants is well articulated in this “topic” from 2012:
GACVS concludes that this comprehensive risk assessment further supports the clinical trial and epidemiological evidence of the safety of aluminium in vaccines. Current research on pharmacokinetics of aluminium in vaccines is ongoing and should be encouraged as a means of further validating and improving this model.
It is of course the same “topic” which damned two papers by Shaw and Tomljenovic (see Handley’s “Big Six”) as ‘seriously flawed‘.
The final reference in this introduction, before they start on the “Generality on Al Adjuvants” is sadly one of the several in French [13]. It apparently called for studies on safety to be carried out, “taking into account a set of parameters so far little studied, which can contribute to the appearance of risk”.
The summary
Which brings us rather back to the key point about this decidedly odd introduction: this “appearance of risk”. They wish to set a scene, where aluminium adjuvants have an appearance of risk. It seems odd that they have found so few papers which actually support this appearance; or at least that is the impression given when you look at what their references actually say.
I found the way they framed the situation beyond disingenuous. From the very start they underplay the benefits of vaccination, and play up (to the point of misrepresentation) the “appearance of risk”. Why, Fischer asked, is there public mistrust of vaccination? One conclusion was that health crises have “left the field open to anti-vaccination propaganda”….
I agree with Fischer, there is most certainly a risk from anti-vaccine propaganda.
I think it is the responsibility of the scientific community, as peer reviewers (be it pre or post publication) of papers like this, to call out such “anti-vaccination propaganda” when we see it.
So, j’accuse.
Author biography
The author of this article has asked to remain anonymous. The author has the letters BA and MSc after her name, due to some odd conventions at certain British universities. She does have a degree in science. She spent her career working as a laboratory-based scientist, including research and development. PCRs were a speciality.
Since having children she has become fascinated with the “Vaccine Discussion”. She has become involved in voluntary science communication work and has recently been published in a peer-reviewed journal on the subject.
For the last three years, she has been a lay member of a public patient involvement group involved with vaccine research. She is also currently a volunteer in a vaccine trial which had, to her joy, a blinded saline placebo arm.
She has given science-based talks to local groups, she especially enjoys including a practical exercise.
She now styles herself an independent researcher (yes, we all know what that means); and is rather enjoying the deep, deep peace of the sofa, after the hurly-burly of the fume cabinet.
Notes
- As was stated in the previous section, the author is British, so there will be numerous non-American spellings of words. Please grammar and spelling Nazis, take that into consideration.
- Turnover is a British word for revenue in finance. It’s not a pastry in this case.
- This relationship between vaccines and chronic fatigue syndrome (and other related conditions) nonsense has been thoroughly refuted.
- The relationship between HPV vaccine and CRPS has also been thoroughly debunked.
- There is no link.
- Macrophagic fasciitis can be best described as a fake disease, which apparently only has been found in France. It is not recognized by any medical or scientific body of any note. It’s just one of the things that the anti-vaccine world has invented to make it seem like there are serious issues with vaccines.
- Medical Hypotheses is a journal that publishes “opinion pieces” about controversial scientific ideas. These articles are rarely supported by data and evidence from the scientific method. The journal used to publish articles without peer review but has changed that policy recently. The journal has an abysmal impact factor of 1.066. It is not considered a reliable source for quality scientific evidence.
- Once again, ASIA is not a recognized condition, and its existence has been debunked by numerous scientists.
