If you’ve paid any attention to anti-vaxxers, or are on the mailing list of some annoying conservative, you may have heard this one: there is a peer-reviewed study in an established science journal that shows that vaccines kill almost as many people as the pandemic. Oh no, you might say, maybe I shouldn’t get vaccinated if doing so has a significant risk of death!
Unfortunately, as I’ve said before, sometimes complete bollocks slithers through the peer-review process, and this is no exception. It’s such utter garbage that the board of the guilty journal is experiencing a wave of resignations in protest
Several reputed virologists and vaccinologists have resigned as editors of the journal Vaccines to protest its 24 June publication of a peer-reviewed article that misuses data to conclude that “for three deaths prevented by [COVID-19] vaccination, we have to accept two inflicted by vaccination.”
Since Friday, at least six scientists have resigned positions as associate or section editors with Vaccines, including Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, and Katie Ewer, an immunologist at the Jenner Institute at the University of Oxford who was on the team that developed the Oxford-AstraZeneca COVID-19 vaccine. Their resignations were first reported by Retraction Watch.
It’s a case study in how to destroy a journal’s reputation with a single stupid paper.
The paper is a case of “garbage in, garbage out,” says Helen Petousis-Harris, a vaccinologist who directs the Vaccine Datalink and Research Group at the University of Auckland and who also resigned as a Vaccines editor after reading the paper. Diane Harper, an epidemiologist at the University of Michigan, Ann Arbor, who was founding editor-in-chief of Vaccines, also resigned, as did Paul Licciardi, an immunologist at Murdoch Children’s Research Institute in Parkville, Australia, and Andrew Pekosz, a respiratory virologist at the Johns Hopkins University Bloomberg School of Public Health.
The resignations began Friday, the day after the paper was published. By early Monday, Fanny Fang, the journal’s managing editor, wrote to the editorial board members that Vaccines—a reputable open-access journal launched in 2013 by Basel, Switzerland–based publisher MDPI—had opened an investigation into the paper. “We are treating this case with the utmost seriousness and are committed to swiftly correcting the scientific record,” she wrote.
The first obvious problem is that none of the paper’s authors have any expertise in the field. Further, the reviewers who let it through are similarly bereft of experience. Despite the fact that the journal is titled Vaccine, apparently some of the editors are also lacking in relevant knowledge.
None of the paper’s authors is trained in vaccinology, virology, or epidemiology. They are: Harald Walach, a clinical psychologist and science historian by training who describes himself as a health researcher at Poznan University of Medical Sciences in Poland; Rainer Klement, a physicist who studies ketogenic diets in cancer treatment at the Leopoldina Hospital in Schweinfurt, Germany; and Wouter Aukema, an independent data scientist in Hoenderloo, Netherlands.
The three peer reviewers on the paper, two of them anonymous, did not offer any substantial criticism of the authors’ methodology in these brief reviews. One of them, Anne Ulrich, a chemist who directs the Institute of Biological Interfaces and is chair of biochemistry at the Karlsruhe Institute of Technology in Germany, wrote that the authors’ analysis “is performed responsibly … and without methodological flaws … and the results were interpreted with the necessary caveats.”
To make it worse, the authors relied on data from a Dutch study…and the authors of that study are saying that their work was misused and inappropriately interpreted.
On 25 June, the day after the paper’s publication, Lareb’s head of science and research, Eugène van Puijenbroek, sent an email to Vaccines’s editors, criticizing the paper and requesting a correction or retraction.
“A reported event that occurred after vaccination is … not necessarily being caused by the vaccination, although our data was presented as being causally related by the authors,” van Puijenbroek wrote. “Suggesting all reports with a fatal outcome to be causally related is far from truth.”
He also took the authors to task for stating in the paper that “the Dutch [registry] data, especially the fatal cases, were certified by medical specialists.”
“This point is simply incorrect,” van Puijenbroek wrote. “The authors seem to refer to [Lareb’s] policy plan. However, in this plan (in Dutch), it is nowhere mentioned that the reports are ‘certified’ by medical specialists.”
Woopsie. The paper has since been retracted, and the journal is doing an in-house investigation of how this screwup occurred, but it looks to me like a whole lot of the people competent to carry out such an investigation have up and quit altogether. And the damage has been done. The anti-vaxxers will continue to cite the paper — they still think Andrew Wakefield’s work was credible — and they’ll scream “Cover up!” at the retraction.
It always bothers me when people resign in protest rather than just vocally protesting something. If all the good, smart, knowledgeable people on their editorial board resign, who’s left to police/protest future fuck-ups like this? It feels like ceding the field to the know-nothings instead of using one’s position to fight back in more effective ways. At the very least, make them fire you for refusing to cooperate with ignorance.
Rebecca Watson just did a video on bad science paper published by MDPI about artificial sweeteners. It seems MDPI has a strategy of spamming researchers to review papers outside their field in order to speed up the review process and collect publishing fees.
From Wikipedia, it says MDPI was responsible for some famously bad papers: “helixes explain everything” about evolution and the cosmos, glyphosphate causes every disease known to man, watching porn causes erectile disfunction, scientists are covering up harm caused by cell phones, and a few papers promoting scientific racism.
Harald Walach is a German pseudo-scientist.
Here’s some info on his exploits (in German):
https://www.psiram.com/de/index.php/Harald_Walach
It’s hard not to.
They are dying by the tens of thousands in the USA as we watch, of Covid-19 virus infections.
99% of the people now dying of Covid019 virus are unvaccinated and most of these are antivaxxers.
At the same time, we are throwing out large numbers of vaccine doses that are outdated and we can’t even literally give away.
These antivaxxers are just Plague Rats.
We are now seeing outbreaks of Covid-19 virus in the USA. Again.
In the areas with high numbers of antivaxxers of course.
These are mostly areas in Red states with high numbers of white fundie xians.
We will have localized outbreaks of Covid-19 virus well into the fall and winter in parts of the USA.
Ridana@1–
It’s often a difficult question whether to resign in protest or try to stick around to repair the damage, but in this case I would have absolutely no hesitation in resigning if I were one of the editors.
From reading lots of case reports and from personal experience (not just scientific journals, but generally), if a failure comes from board/governance level then the damage can never be fixed until important people resign in protest. Also remember that the people resigning have their own reputations to think of. Why should they sacrifice their hard-won credibility and professional values to restore the standing of the editorial bastards and/or incompetents who let this paper through? Also note that one of the resigning editors has made it clear that she will consider returning if this is handled well by the journal.
It’s a problem that academic editors and peer reviewers aren’t paid. It’s hard to find people to do it. I’m an editor for a well-known journal, and I constantly get requests to handle papers that are outside my expertise. I turn them down but obviously not everyone does.
From the Nature article: ‘The three authors submitted a rebuttal to Vaccines’s expression of concern on 29 June. In it, they write that they interpreted Lareb’s public statements “to mean that those reports that are obviously without any foundation are taken out such that the final data-base is at least reliable to some degree.”’
Lareb is the Dutch national post-marketing surveillance system for pharmaceuticals. Their protocol is designed to scoop as many reports as possible to look for possible data signals rather than determine causality — which is intrinsically impossible for them to estabish. And Lareb explains this on their website: “Healthcare providers and people who have been vaccinated can report (suspected) side effects. Based on analysis of reports, any new side effects can be detected.” And even more clearly: “In the Netherlands there are reports of death after corona vaccination. Death after vaccination does not mean that the death was caused by the vaccination.” And indeed the reported deaths include breast cancer, fracture, urinary infection, and Alzheimer’s disease — unlikely to be related to the COVID vaccine.
Lareb makes very clear that the data cannot be taken as causal.
I also note that the methodology in the retracted paper was appalling. They openly state that they chose the Dutch data because it showed the most adverse events of all European centres. Not joking. Here is the direct quote: “While the European average is 127 individual case safety reports (ICSRs), i.e., cases with side effect reports, per 100,000 vaccinations, the Dutch authorities have registered 701 reports per 100,000 vaccinations, while Poland has registered only 15 ISCRs per 100,000 vaccinations. Assuming that this difference is not due to differential national susceptibility to vaccination side effects, but due to different national reporting standards, we decided to use the data of the Dutch national register (https://www.lareb.nl/coronameldingen; accessed on 29 May 2021) to gauge the number of severe and fatal side effects per 100,000 vaccinations.” I don’t believe they intended to data mine, because there’s no way they would have admitted it so brazenly. I just think they don’t understand enough about research principles to see why this is completely wrong.
They also chose, of the available effectiveness studies, one from Israel, which has thus far had much fewer COVID deaths than most European countries (710 deaths per million cf. UK 1923, France 1657, Italy 2114, etc. — out of all Europe, only Denmark and Norway and Finland have relatively light death rates due to their proactive infection control model). Obviously if a country has fewer cases per million, any preventive activity will show fewer benefits. And anyone with even basic understanding of study design knows you can’t just pull the numerator and denominator from different studies, let alone different data types in different populations.
Finally, I note that the NNT they calculated was based on data collected up to 4 weeks post-vaccination. But for population-based vaccine trials the NNT will improve the longer you follow participants because most of your participants will not have been exposed to infection in your study’s 4-week window. As most people aren’t expected to die of COVID within the given 4 week period, this leads to a massive underestimate of the NNT. It is essentially a meaningless number at 4 weeks post-vaccination. Studies instead report vaccine effectiveness and/or efficacy. Please never repeat this as a serious calculation, I’m only writing this to illustrate the point, but 4 weeks is about 1000th of an average lifespan, so that NNT of 16,000 after 4 weeks is roughly an equivalent lifetime NNT of 16. This is obviously not meant to be an accurate estimate, but I hope the point is clear that calculating NNTs based on tiny fractional windows of total benefit duration is woefully ignorant.
cervantes@7–
I hope this was just a case of people doing their best outside their expertise because of limited resources, but this looks to me like an inside stitch-up where the paper was farmed out to known sympathisers. After all, one might be tempted to go a bit outside one’s expertise, but what in Om’s name is a biochemist doing refereeing an epidemiology paper? Why did none of the referees identify any of the myriad poor methodologies? We’re not talking about one or two subtle but important oversights here, we’re talking favourable reports on the hull integrity of the Titanic while sinking.
I hesitate to ask, but what was the most out-of-field refereeing request you remember?
BTW, I’m all in favour of paying referees. Given Reed Elsevier’s >$1 billion annual profit off publicly funded research, it’s the least they can do. I’m also against referee anonymity.
well mission accomplished science has been discredited again.
Meanwhile, thousands and thousands of women and others who menstruate have reported shifts in their monthly cycle after receiving the vaccine and are told that it’s probably their nerves.
Yes you heard that. Instead of being taken serious, we’re patted on the head and told not to worry our pretty little heads off.
@ 12 Giliel
Meanwhile, thousands and thousands of women and others who menstruate have reported shifts in their monthly cycle after receiving the vaccine and are told that it’s probably their nerves.
Refs?
@Giliell — Yes, stress can affect the menstrual cycle. The vaccine isn’t doing it.
@jkrideau
They didn’t track menstrual cycles in the original vaccine studies. This is a response to people voluntarily reporting it (myself including) to vaccine tracking information afterwards. It’s something that’s not generally tracked at all by studies, even when they choose to include enough uterus-barers in the study.
And I’ve had a period for a good 30 years now- I can tell you if it’s “stress” effecting it or an outside source. It came early (from being regular for the last 5 years that I’ve tracked it on an app) and was heavier than usual. It is very irritating to be told “It’s just stress”.
antigone10–
Uterus-barers or uterus-bearers?
Several points:
First, I think it’s unacceptable and evidence of sexist disparities in health care and research when menstrual cycles aren’t followed as a part of clinical trials.
Second, I don’t really understand the minimization of stress generally. Stress causes and contributes to a number of acute and chronic conditions, and can totally interfere with periods. No one, and especially not medical professionals, should use phrases like “just stress” or “only stress.” We’re collectively dealing with a massive amount of baseline stress during the pandemic (some far more than others), and getting vaccinated – even if it’s something we’re happy about and excited for – is still stressful.
Third, I don’t see any reason the vaccination itself wouldn’t cause these disruptions. I was knocked out for 24 hours by the second dose – I’m not sure why it wouldn’t be expected to have a variety of physiological effects. (I do think it’s odd that I’ve only seen this discussed in the context of people who menstruate, like no one else has hormones…)
Finally, and I recognize this could be coming from a place of bitterness, I’m open to explanations but I’m not sure I understand why this is such a big deal.
You try being post-menopausal or being on hormone therapy for gender dysphoria for years and getting rid of all your menstrual supplies and suddenly bleeding on your underwear. Being a menstruating person with unpredictable cycles means carrying a purse, always, so you have supplies just in case. It means having headaches, cramps, diarrhea, clumsiness, irrational anger or weepiness, and/or unpredictable blood on your underwear. It means having three days every so often when you need to take 2 aleve (not advil) every 4-8 hours (or 3-4 aleve every 12 hours) and sleep with a heating pad just to make it through. It means buying pantyliners and four types of tampons. Between the tampons and the painkillers and replacing the mug you dropped because your hand-eye coordination is off, it’s expensive. You have to prepare, to organize your life so you’re not taken unawares and have to wrap toilet paper around your underwear so you don’t get blood on your clothes.
It’s a big deal because menstruating unexpectedly has a huge impact on mental health and social function, and because it’s logistically (and sometimes economically) complicated.
signe @ #18, my previous post was probably not explicit enough when I said “I recognize this could be coming from a place of bitterness.” Like, the longest this could have been a post-vaccine problem for people right now is two or three months. Many, many people know what it’s like to experience these things for years if not decades. If this is still a post-vaccine issue for people several months from now or if there’s a reproductive problem demonstrably linked to vaccines, then I’d of course recognize the seriousness.
A lot of the supposed worry about vaccination side-effects is due to conflating correlation and causation. Sure, people have got sick or even died after getting a vaccine, but people also have have got sick or even died after eating a meal or sleeping in a bed.
So I could write a book about the systemic discrimination against menstruating people and particularly those with difficult periods. Obviously, people in war zones, shelters, refugee camps,… have it the worst, but it’s a problem everywhere. So far, vaccines seem fairly irrelevant.
It has been observed and related since spring 2020 that covid-19 itself altered or correlated with menstrual cycle changes in some of those infected (the reasons are not clear, but sex hormones registered no similar change) and that these effects appeared to be temporary, much like those associated with the vaccine itself. As has been discussed here, stress could also be a factor. Covid-19 and vaccinations are novel; aggravating postmenopausal bleeding from stress is not. So we’re back to pretending the cure is somehow worse or indistinguishable from the ailment and from reality itself.
@19
Sorry, I didn’t make my point clearly.
If you’re cisgender and irregularities happen before menopause, it will be scary but manageable because you probably have the supplies to deal with it.
But if you’re post-menopausal it can be a big problem, partly because you don’t keep supplies on hand and partly because it’s very scary – that level of hormonal disruption happens very rarely, and when it does, standard advice is to see your gyn and get screened for cancer.
And if you’re trans and have successfully avoided having to think about having a female body for years, it can be seriously traumatic from a mental health standpoint as well – both the bleeding and the having to buy and use supplies.
It’s something that’s important to warn people about so they can be prepared – and therefore it’s something that should be tracked in the studies and trials.
Ridana @ 1
As noted in the final two paragraphs from the article PZ linked to above, least one of the board members has said she would be glad to return if Nature embarks on a full reckoning here. That’s the precise outcome one is angling for when they protest-resign like this. Resignations work. They are a great tool in making authorities and employers accountable. Kudos to the board.
signe @ #23, the comments to which I was responding referred to people experiencing “shifts in their monthly cycle” and a period that “came early…and was heavier than usual.” What you describe – people who are post-menopausal or on hormone therapy for years suddenly experiencing bleeding or full periods – is much more extreme, but definitely important to discuss.
Anyway, here’s a good BBC piece on the subject – “Covid vaccine: Period changes could be a short-term side effect.” (A doctor they speak with suggests that people report unusual bleeding to their doctor. Certainly if it’s not temporary – as you seem to suggest @ #18 – people should get medical help.)
It’s interesting that you go from a full description replete with italics describing it – and I’ll note again that for many people this is the regular experience – to “it’s manageable.”
Yes, as I said @ #17.
Another good article, in Women’s Health – “Does The COVID-19 Vaccine Affect Your Menstrual Cycle? Here’s What Experts Say.”
FYI, the only verified instance in modern times of a harmful vaccine happened a decade ago in Scandinavia.
A single batch of a vaccine for the Swine flu created antibodies that accidentally matched some molecule produced by the endocrinal system, causing a few hundred to get, wossname, that disease where you fall down asleep on your feet.
It is a serious, life–alteting condition, but the odds of vaccine doing something like this is literally one in several million. When comparing this to the excess mortality from Swine flu, I still consider that vaccination program justified, even more so as It was confined to parts of Scandinavia.
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I might say the Scandinavian anti-vaxxers are the only ones to have a leg ro stand on , as distinct from the Anglo-saxon ones (the latter having been primed to see conspiracies everywhere by the likes of Murdoch and other bottom-feeders).
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Another thing that made people question vaccines was when US intelligence used a bogus vaccine team to get access to Bin Laden, causing a perfectly predictable backlash against vaccinations in the region.
Whenever we look for avoidable vaccine fuckups, it is about dumb politicians and far- right media.
Oh ffs, I don’t know any woman for whom getting the vaccine was any considerable amount of stress. Really, do you think we’re such delicate and fragile creatures that going into a vaccine clinic /doctor’s office to get a jab, something most of us have done a couple of dozen times suddenly stresses us out so much that we start bleeding incontrollably? That’s the same fucking Bullshit of the original “hysteria” hypothesis.
We’ve all been running damn stressful lives. We lived through more than a year of a pandemic. Suddenly our kids were home, even if we weren’t. If we were, we had to manage supporting our kids and working at the same time.
I’m a teacher. I was home for a few weeks with my kids, which wasn’t fun for any of us, and then I was in school with varying learning groups. And school was hell this year, because the v kids were suffering and they let it out where they felt safe with Covid restrictions not being helpful. Everyday I went in there wondering if that was the day I would finally catch Covid. Every day I had to decide between protecting my health and meeting my pupils’ needs. And I, as well as thousands of women ploughed through this. And now you’re trying to tell us that the event that meant that we would not die, that our children would not lose their mothers, was too much for our silly little nerves? Really?
@birgerjohansson
Do they hava a leg to stand on? AFAIK it is not as definitive as usually presented. The actual virus, for example, can also trigger the auto-immune response and it is not clear if the affected people were infected or not. (See https://www.statnews.com/2018/07/05/flu-vaccine-2009-pandemic-narcolepsy/)
@Giliell
I think the unstated assumption is that people reporting this are anti-vaxers who fear Covid more than vaccines (thus the stress). It doesn’t help that it is usually presented with other anti-vax claims (“shedding”).
ChrisE84
No. Enthusiastic no. The claims and research are driven by serious pro bad scientists who also happen to menstruate. Women and others afab wanting to be finally seen in research is not some stupid anti vax thing. Especially since you had to get the vaccine to notice the effect in the first place. And none of the folks I saw talking about it were suddenly against their second shots or advising others to forgo the vaccine. All they and me wanted was for the effect to b free taken serious, maybe have it researched, because hey, we could learn something, and for others to get a heads up. It’s that too much to ask so we can pack some extra hygiene products?
I’ve been told that this effect isn’t even surprising for any vaccine or viral infection.