A paper claiming that myocarditis cases spiked after teenagers began receiving COVID-19 vaccines has earned a “temporary removal” — without any explanation from the publisher.
[Please see an update on this post.]
The article, “A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” was published in Current Problems in Cardiology, an Elsevier journal, on October 1.
It was co-authored by Jessica Rose and Peter McCullough, whose affiliations are listed as the Public Health Policy Initiative at the Institute of Pure and Applied Knowledge — a group that has been critical of vaccines and of the response to COVID-19 and has funded one study that was retracted earlier this year — and Texas A&M’s Baylor Dallas campus. [See update at the end of the post.]
Last month, Baylor Scott & White obtained a restraining order against McCullough — whom Medscape says “has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines” — for continuing to refer to an affiliation with the health care institution despite a separation agreement. “Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed McCullough from their faculties,” Medscape reported at the time.
Here are some highlights of the now temporarily retracted paper’s claims:
Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males.
While several studies have used the VAERS database and other similar datasets around the world to estimate rates of side effects from COVID-19 vaccines, the approach has been roundly criticized and has led to at least one retraction. VAERS itself includes caution against doing so. (Another paper about myocarditis cases linked to COVID-19 vaccines has been retracted for a serious math error.)
Here’s the notice:
The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.
The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.
Rose, the corresponding author of the paper, told Retraction Watch that the publisher had “applied the ‘temporary withdrawal’ label to the paper without informing us.” The publisher, Rose said, “claimed that since ‘it wasn’t an invited paper’ that they were reconsidering publishing it and hence the ‘temporary withdrawal.’”
She said the move was “unheard of” and that Elsevier was “breaching the contract we signed – all fees have been paid for gorgeous color graphics.”
Elsevier has temporarily removed more than 100 papers since 2005, by our count. The papers are often reinstated without any mention of why the paper was removed.
Hector Ventura, the editor of the journal, did not immediately respond to a request for comment.
Update, 10/17/21, 1850 UTC: Rose tells us that the correct affiliations — now noted on the temporarily retracted version — are the Institute of Pure and Applied Knowledge’s Public Health Policy Initiative (PHPI) for her, and the Truth for Health Foundation in Tucson, Arizona for McCullough. The foundation describes its mission as:
To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.
To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.
The paper was submitted before McCullough’s departure from Baylor, Rose said.
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The Medscape article mentions McCullough’s “Truth for Health Foundation” affiliation, though without going into detail about its “faith-based integrated approaches to medical treatment” (maybe he’ll pray for patients).
Regarding this line: “The paper was submitted before McCullough’s departure from Baylor, Rose said.” – how can that be so? McCullough left Baylor in February 2021. The paper was submitted in either August or September. (one reference in their paper cites another paper published in August 2021, long after McCullough’s departure)
Perhaps the manuscript was revised after review and before final acceptance, thereby incorporating intervening publications?
That’s how very recent papers can be cited, even though they were published after the original submission date of the manuscript.
If the authors had seized an opportunity to update the References then they also had an opportunity to update their affiliations.
Affiliations are not normally updated. They are usually as of the submission date… Your comment seems petty.
Affiliations are not usually falsified and in breach of a court restraining order.
While terminating a contract w such an experienced and well-credentialed clinician as Peter McCollough, MD certainly exerts influence on what can and cannot be included in a truly scientific discourse, we should all be horrified that undue institutional influences could in any way suppress raw data that is appropriate for attention of a spectrum of professional communities.
Retraction Watch readers here need to find a way to deal with their cognitive dissonance in response to information that one would rather not have to consider.
Hackneyed media headlines nor intellectually torpid, myriad, assumptions simply do not constitute clear analyses, much less knowledgeable understanding.
Even a basic scientific curiosity, or taking note of ones assumptions, would be superior to speculative tangential comment – clearly aiming to undermine otherwise properly performed work through highly-credentialed medical academic clinicians.
The focus on quotes alluding to IRS rules (of all things) of some presumed legal case is certainly dubious coverage of medical academic journal veracity. Here it not only obviously creates a dismissive effect of the authors and their careers, but moreover appears to be a red herring for diversion from safety concerns – which in an ethical scientific medical community need to be unassailable.
The journal needs to clarify why it had been taken it down, especially given the amount of attention it had already received.
Otherwise, this feeds the claims that it was simply taken down based on its viewpoint, which just further exacerbates the divisiveness in society.
As long as it went through proper peer review and there are no other demonstrable irregularities with the work, the paper should be allowed to stand.
Those that want to critique the methodology, messaging or any other aspect of the work are then free to do so.
Yes, exactly. I’m not expert in the field, but rejecting paper from accomplished experts, with some peer review *with no explanation* looks terrible.
Update: Elsevier has since said this is no longer temporary, they have completely rejected paper. The email was very short with absolutely no explanation. Basically it says “hey you signed the contract – fine print say we can reject any time for any reason – end of story”
See youtube “darkhorse” podcast 101.
Rejected for challenging orthodoxy. Not a good look for a theoretically academic journal…
Rejected for incompetence and not-even-wrongness. The initial provisional acceptance was not a good look for a theoretically academic journal.
“The journal needs to clarify why it had been taken it down, especially given the amount of attention it had already received.”
Perhaps because the posted article is an “In Press, Journal Pre-Proof” (see the link at the top of the archived article) and has now undergone final revision for publication and will be replaced by the final version at some point in the future? Like when the article is actually published in the paper version of the journal?
So in the end there is nothing really nefarious about the articles temporary removal. It has simply been revised to it’s final version and awaits publication.
Geez, everyone so quick to assume the worst. Especially when the article deals with The Covid.
Information on “In press, Journal Pre-Proof” articles:
https://service.elsevier.com/app/answers/detail/a_id/22799/supporthub/sciencedirect/
From the Elsivier web site:
Article withdrawal
Only used for Articles in Press which represent early versions of articles and sometimes contain errors, or may have been accidentally submitted twice. Occasionally, but less frequently, the articles may represent infringements of professional ethical codes, such as multiple submission, bogus claims of authorship, plagiarism, fraudulent use of data or the like. Articles in Press (articles that have been accepted for publication but which have not been formally published and will not yet have the complete volume/issue/page information) that include errors, or are discovered to be accidental duplicates of other published article(s), or are determined to violate our journal publishing ethics guidelines in the view of the editors (such as multiple submission, bogus claims of authorship, plagiarism, fraudulent use of data or the like), may be “Withdrawn” from ScienceDirect.”
From the commenter above:
“Perhaps because the posted article is an “In Press, Journal Pre-Proof” (see the link at the top of the archived article) and has now undergone final revision for publication and will be replaced by the final version at some point in the future? ”
The authors say otherwise. They’ve been told nothing, and this is not S.O.P.
It is my understanding from media reports that myocarditis resulting from covid vaccines is a real thing – I just heard it reported on public radio recently. There was a report on a professional baseball player last year. If there were a normal problem with the paper – as there are with many papers – the editor would surely be in communication with the authors. The radio silence makes it look suspicious. There is no reason why a vaccine should not have side effects – aspirin and tylenol do. So what’s with the zero dark thirty procedures?
You are quoting the text under ‘Article Withdrawal’ but this paper has a ‘Temporary Removal’ notice and ‘removal’ has a different explanation, from the Elsevier website:
Article removal: legal limitations
In an extremely limited number of cases, it may be necessary to remove an article from the online database. This will only occur where the article is clearly defamatory, or infringes others’ legal rights, or where the article is, or we have good reason to expect it will be, the subject of a court order, or where the article, if acted upon, might pose a serious health risk. In these circumstances, while the metadata (Title and Authors) will be retained, the text will be replaced with a screen indicating the article has been removed for legal reasons.
The article was not withdrawn.
From the Elsivier web site:
—–
What are journal pre-proofs?
Last updated on September 23, 2021
Journal pre-proofs are Articles in Press that have been peer reviewed and accepted for publication by the Editorial Board of this publication. They have undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but are not yet definitive versions of record. These versions will undergo additional copyediting, typesetting and review, and may not yet have full ScienceDirect functionality. For example, supplementary files may still need to be added, links to references may not resolve yet, etc. The text could still change before final publication.
Although journal pre-proofs do not have all bibliographic details available yet, they can be cited using the year of online publication and the DOI, as follows: author(s), article title, Publication (year), DOI. Please consult the journal’s reference style for the exact appearance of these elements, abbreviation of journal names, and use of punctuation.
When the final article is assigned to a volume/issue of the publication, the Article in Press version will be removed and the final version will appear in the associated published volumes/issues of the publication. The date the article was first made available online will be carried over.
—–
I suspect that this is simply a case of the article being removed temporarily as the article is now going to be published in an actual journal and that the final copy will replace the removed version once the publication has been released.
So again, nothing possibly nefarious about the removal of the article. Just done in anticipation of publishing the final version. That is all.
Again, this paper is using VAERS, which is not a diagnostic system but an extremely sensitive (and highly non-specific) system. Using it to identify actual risks, when there are much better tools around, is misleading. Foolish at best. For details, see here; https://sciencebasedmedicine.org/dumpster-diving-in-vaers-doctors-fall-into-the-same-trap-as-antivaxxers/
I agree with your criticism of the methodology, but that is what peer review is supposed to catch.
If this is the reason, that the journal is taking the paper down because they think that the methodology or data in the paper is not appropriate, it seems like they at least owe an explanation to the authors who received a notification of acceptance and to the public, many of whom already read, discussed and in some cases cited the posted preprint on the journal website.
Yes exactly. Silent rejection of a paper from accomplished experts from prestigious journal is wasteful, as part of value of rejection is feedback.
The problems with VAERS an early warning vaccine safety reporting system in use for more that 30 years are well known but that article you quoted is by someone who sounds like a rather pompous ass who greatly overestimates his actual relevant domain expertise. On this and many other subjects. His other musings scientific in the past have not been that impressive. Long on attitude, short on actual demonstrated expertise. Based on the evidence of what was written.
When VAERS cases data is used comparatively, say influenza versus other vaccines, mathematically significant trends can be noted. When adverse response events reported to VAERS are matched with the results from clinical trials for previous vaccine candidates in the 505(b)1 approval process for example then mathematically significant conclusions regarding relative safety can be drawn.
The VAERS system is far from perfect. It has the same issues as EUdraVigalence etc set up for the same purpose. The problem is not so much the quality of the data collected, which it has, its the fact that as an early warning product safety system it seems to have such a low capture rate for short term adverse effect events and totally unsuitable for detecting any longer term adverse effect events trends. As discussed in the published literature.
Which is somewhat different from the rather facile piece in the quoted article. As someone from a serious mathematics background I am shocked, but not really surprised, at both the low quality of the understanding of the mathematics shown in most bio-science papers and just how often very basic mathematical errors invalidate the conclusions of so many papers. The data presented is often quite useful, but the data analysis and conclusions are usually on very shaky ground if not completely wrong.
Such as a mathematical assumption that is very reasonable (and valid) for a population of lab mice (exceptionally homogeneous population in a very controlled environment) for example is not going to hold true when applied to the typical (non-random, very heterogeneous, uncontrolled environment) human population found in most studies.
I understand the many limitations in medical research but unfortunately due to very dodgy math most of the papers read as basically little more than large collections of anecdotal data with some pretty graphs. Often still very useful when read as such but the problems starts when the dodgy math and its conclusions escapes to roam in the wider world.
But thats another subject.
To use VAERS comparatively, don’t you have to assume that the response rate and other systematics are comparable? That seems like a dubious assumption for COVID-19.
Then the CDC is operating illegally. In October 2020, the CDC stated that the would be monitoring the safety closely by VAERS, analysis, testing and autopsies. Where are they? Nowhere. How many deaths are required to stop this experiment? All the Vaccines are operating under an EUA meaning not all of the procedures have been done. Even the CDC is looking at Myocarditis: Here is their slide. https://1.bp.blogspot.com/-K645x-PyjY0/YXn7wwPAGpI/AAAAAAAAEGc/coTSifAHd7wTq5MopPP-OBPxZOfPWN8YwCLcBGAsYHQ/s640/Table%2B2.jpeg
Jessica Rose says in a recent podcast: “About 10 minutes ago, I got a notification by e-mail from the publisher of the journal that it will not be published”
33:00 mark: https://podcasts.apple.com/us/podcast/vaccine-researcher-jessica-rose-and-dr-peter-mccullough/id1513237951?i=1000539459117
Elsevier gave no explanation. Essentially they said “you signed the agreement, we can cancel at any point without reason”
Which is pretty unusual. A peer reviewed paper, by prestigious authors, to journal being rejected by Elsevier with no explanation. Can someone point to another example of this?
I can’t point to another example of a doctor under a restraining order to stop claiming they are affiliated with their former institution, and then doing exactly that in a published paper. If this inexplicable temporary removal is without precedent, so are the circumstances which led up to it..
I wonder about the peer review process for this paper. There are references cited that are extremely questionable. For example, Reference 39 “IPAK Report 2021-1. 2021. Post-vaccination Death Causality Likely Given Temporal Distribution of Deaths Following COVID19 Vaccinations. Interim results.” [note: Jessica Rose is affiliated with IPAK] is a 3 slide power point file with no sources cited: http://webcache.googleusercontent.com/search?q=cache:PS3RN6r-vPAJ:ipaknowledge.org/resources/VAERS%2520deaths%2520to%25203%252010%25202021%2520update%25203.pptx+&cd=1&hl=en&ct=clnk&gl=us
There are other examples, but these are things you might have imagined ‘Peer Review’ would have caught.
The following tells you all you need to know about the integrity of the retraction process for papers on highly sensitive topics.
“On August 27, 2014, the following excerpted statement by Dr. William Thompson (a CDC Senior Researcher) appeared on the website of Morgan Verkamp, LLC, a legal organization representing Dr. Thompson (Morgan Verkamp, 2014).“I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed…My concern has been the decision to omit relevant findings in a particular study for a particular sub group for a particular vaccine. There have always been recognized risks for vaccination and I believe it is the responsibility of the CDC to properly convey the risks associated with receipt of those vaccines.”
According to taped phone conversations between Dr. Brian Hooker and Dr. Thompson, not only were the African-American children who received the MMR vaccine at substantially greater risk for autism (as alleged by Dr. Thompson), but according to Dr. Hooker, Dr. Thompson mentioned that children of all races were shown to have an increased risk of ‘Isolated Autism’ (young children, regardless of race, who had (1) received the MMR vaccine on schedule, as recommended by the CDC, and (2) had no other factors sometimes observed to accompany autism, such as cerebral palsy, mental retardation, and birth defects.) The MMR vaccine-autism study to which Dr. Thompson referred had been performed shortly after the turn of the new millennium, and the stated results (no link between MMR vaccine and autism) had been published in the journal Pediatrics (DeStefano et al., 2004). ”
As of this morning, the article has not been retracted by Pediatrics, despite the serious allegations of intentional omission of critical data by one of its co-authors. So, a highly respected epidemiologist for the CDC blows the whistle on himself and the other CDC co-authors for omitting crucial data, and nothing happens on the retraction front. Conversely, a high quality paper on myocarditis with no apparent problems gets retracted with no explanation given, and the usual group of apologists searches under every rock for some far-fetched justification.
I would appreciate your analysis of the paper, to understand how you came to the conclusion that this is a ‘high quality paper on myocarditis with no apparent problems’.
Thanks
I don’t even know how to get the whole paper, only abstract. Do you have link?
Nor am I expert in field. I can say it was peer reviewed n approved.
I don’t see need to prove good paper. I see question of process. Why rejected post peer approval, and why no reason?
I’ve seen 2 possible reasons in comments (low quality reference, author saying associated w group). I think Elsesier needs to give rrDon whatever it is.
If you make unusual post peer approval rejections with no reason you bring suspicion.
I agree, we need things to be done out in the open. I think that I had a pdf of one of Dr. Rose’s papers.
I was interested in Kostoff’s analysis of the paper as ‘high quality’.
You can find comments on PubPeer about this paper, which shed some light on its quality:
https://pubpeer.com/publications/C9EC1C8336F615B6BCA5C724932682
There is also the enigma of References [84, 85, 86, 90, 91, 96, 97, 98, 99, 100], present in the References section but nowhere cited in the text.
To be fair, the Uncited References section is acceptable, if not too common:
https://academia.stackexchange.com/questions/56970/what-is-uncited-references
But numbered uncited references, breaking the sequence of citations, are a failure on everyone’s part.
Dr. Rose seems to have abandoned the world of science for journalism: https://jessicar.substack.com/p/a-report-on-myocarditis-adverse-events
Yikes. Thanks for the link, David. With morbid curiosity, I read the whole thing. That was painful. Suffice it to say that Elsevier made the right move here. And hopefully they permanently barred these particular peer reviewers from ever handling a manuscript again. It was that bad.
Hi, im interested what is painful (wrong) about it? I hope to learn your perspective.
So why can’t Elsevier simply give reason for retraction?
They’ve never mentioned quality of paper.
Rn you state / wrote. ,…………… “It was that bad”
Why, in your opinion it “that bad”?
You’re giving IPAK a bit of a pass here, using “a group that has been critical of vaccines and of the response to COVID-19” as code for “rabid anti-vaccinationists and COVID denialists”.
It’s James Lyons-Weiler’s outfit – the name will be very familiar to anyone who follows the clown bus of vaccine-autism claims.