New England Journal of Medicine: Baden et al
This post, a twin to the New England Journal of Misinformation post, has been created for its hyperlink. It does however play into the current post about cholecystitis following vaccination – in this case with the Moderna vaccine – which features in Tales of an Unexpected Gallbladder.
It also seems to show that NEJM are simply not doing science and are shameless about it. Longo’s way of putting things is jaw-dropping.
RIAT Expression of Concern:
lack of data shared from Moderna Covid-19 vaccine trial
We are writing an expression of concern regarding Moderna’s Covid-19 vaccine phase 3 study (NCT04470427).1,2
The Data Sharing Statement states that the data collected for the study will not be made available to others, but, confusingly, also states that “Access to patient-level data and supporting clinical documents with qualified external researchers may be available upon request once the trial is complete.”1
This statement provides no guarantee that underlying trial data for this global public health intervention will ever be publicly accessible. Even if access becomes available “once the trial is complete,” this may not occur until October 27, 2022, the estimated study completion date according to ClinicalTrials.gov, nearly two years after mass vaccination commenced.3 Since these data underlie the Food and Drug Administration’s Emergency Use Authorization4 in December 2020, data availability is urgent to ensure the transparency, integrity, verifiability, and reproducibility of the trial’s reported results.
We request the authors make the trial data available immediately and adjust the data sharing statement of the publication accordingly through an erratum.
Authors
Anisa Rowhani-Farid, Kyungwan Hong, Peter Doshi
References
- Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med 2021;384(5):403–16.
- Drazen JM. Believe the data. N. Engl. J. Med. 2012;367(12):1152–3.
- A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 [Internet]. [cited 2021 Feb 11];Available from: https://clinicaltrials.gov/ct2/show/NCT04470427
- Office of the Commissioner. FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine [Internet]. 2020 [cited 2021 Feb 11];Available from: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid.
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From: NEJM Letter <onbehalfof@manuscriptcentral.com>
Date: Friday, February 26, 2021 at 3:07 PM
To: Rowhani-Farid, Anisa arowhani@rx.umaryland.edu
Subject: New England Journal of Medicine 21-02760
Dear Dr. Rowhani-Farid,
I am sorry that we will not be able to publish your recent letter to the editor regarding the El Sahly article of 04-Feb-2021. The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received. Many worthwhile communications must be declined for lack of space.
Thank you for your interest in the Journal.
Sincerely,
Dan L. Longo, M.D.
Deputy Editor
New England Journal of Medicine
From: Rowhani-Farid, Anisa <arowhani@rx.umaryland.edu>
Date: Tuesday, June 1, 2021 at 10:44 AM
To: letter@nejm.org letter@nejm.org
Cc: Hong, Kyungwan <hong.kyungwan@umaryland.edu>, Doshi, Peter <pdoshi@rx.umaryland.edu>
Subject: Re: New England Journal of Medicine 21-02760
Dear Dr. Longo,
We are sorry to hear that you will not publish our letter. Apart from our letter itself, the far more important issue is the problems we wrote about. Will the NEJM ask Baden et al. to respond to the points we raised (https://www.nejm.org/doi/full/10.1056/NEJMoa2035389) ? Our letter documented how the article’s data sharing statement says the authors will not share data from their trial, but then seems to contradict that statement by indicating that data “may be available.” This leads readers with no clarity regarding whether Moderna’s Covid-19 vaccine will ever be publicly accessible. We believe public health is safeguarded when data are available for independent scrutiny, and conversely, data secrecy undermines public health, and science.
Best regards,
Anisa Rowhani-Farid, Kyungwang Hong and Peter Doshi
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From: Longo, M.D., Dan dlongo@nejm.org
Date: Tuesday, June 1, 2021 at 4:37 PM
To: arowhani@rx.umaryland.edu arowhani@rx.umaryland.edu
Cc: hong.kyungwan@umaryland.edu <hong.kyungwan@umaryland.edu>, pdoshi@rx.umaryland.edu <pdoshi@rx.umaryland.edu>, Letter <letter@nejm.org>
Subject: data sharing by Baden et al
Our policy mandates that the authors’ data sharing policy be disclosed, not that their data must be shared. The authors of this paper stated their data sharing policy. My interpretation of the “may be available” statement is that interested investigators should contact the authors directly for any requests. It is unfortunate that you find this confusing. I suggest you contact the authors directly.
Dan L. Longo, M.D., M.A.C.P.
Deputy Editor, New England Journal of Medicine
Professor of Medicine, Harvard Medical School
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From: Rubin, Eric erubin@nejm.org
Date: Tuesday, June 1, 2021 at 4:38 PM
To: Longo, M.D., Dan <dlongo@nejm.org>, Rowhani-Farid, Anisa arowhani@rx.umaryland.edu
Cc: Hong, Kyungwan <hong.kyungwan@umaryland.edu>, Doshi, Peter <pdoshi@rx.umaryland.edu>, Letter <letter@nejm.org>
Subject: Re: data sharing by Baden et al
That works – thanks.
Eric
From: Doshi, Peter pdoshi@rx.umaryland.edu
Date: Tuesday, June 1, 2021 at 9:42 PM
To: Rubin, Eric erubin@nejm.org
Cc: Longo, M.D., Dan <dlongo@nejm.org>, Rowhani-Farid, Anisa <arowhani@rx.umaryland.edu>, Hong, Kyungwan <hong.kyungwan@umaryland.edu>, Letter <letter@nejm.org>
Subject: Re: data sharing by Baden et al
Dear Drs. Rubin and Longo,
Many thanks for the quick response and your attention to this matter.
The problem we are trying to convey is that the Data Sharing Statement makes contradictory statements. It both states “No” in response the question “Will the data collected for your study be made available to others?” and also that data “may be” available. We can’t see how the answer can simultaneously be both “no” and “maybe”.
We appreciate your suggestion to contact the authors, and will do so.
Separately, isn’t the lack of public data availability a matter of great concern, considering that many millions of people are using this product? Publishing our letter–or even better, a statement from the NEJM editors expressing concern about this–would help put this issue of data inaccessibility on the map, and might actually compel better practice.
Best,
Peter
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From: Longo, M.D., Dan dlongo@nejm.org
Date: Tuesday, June 1, 2021 at 9:58 PM
To: Doshi, Peter <pdoshi@rx.umaryland.edu>, Rubin, Eric erubin@nejm.org
Cc: Rowhani-Farid, Anisa <arowhani@rx.umaryland.edu>, Hong, Kyungwan <hong.kyungwan@umaryland.edu>, Letter <letter@nejm.org>
Subject: Re: data sharing by Baden et al
I am not sure what limits your ability to understand that the company that owns the data has no plan to release it publicly but is willing to share data with legitimate investigators who have a question they would like to address collaboratively. The statements do not seem contradictory to me. My interpretation is that qualified individuals are invited to approach the company and propose collaborations using the company’s data.
Data sharing seems like a good idea. We have limited capacity to force a private commercial entity to make their proprietary data publicly available. They have made a substantial amount of data public in the form of the published paper. Do you think we erred in publishing the results of a life-saving vaccine because the authors do not wish to share the data they paid to generate? These data belong to them and, at the moment, they are free to decide what to publish and what not to publish.
Dan L. Longo, M.D., M.A.C.P.
Deputy Editor, New England Journal of Medicine
Professor of Medicine, Harvard Medical School
From: Doshi, Peter pdoshi@rx.umaryland.edu
Date: Tuesday, June 1, 2021 at 10:43 PM
To: Longo, M.D., Dan dlongo@nejm.org
Cc: Rubin, Eric <erubin@nejm.org>, Rowhani-Farid, Anisa <arowhani@rx.umaryland.edu>, Hong, Kyungwan <hong.kyungwan@umaryland.edu>, Letter <letter@nejm.org>
Subject: Re: data sharing by Baden et al
Dear Dr. Longo,
With respect to the Data Sharing Statement, I did not assume that the first question referred to publicly releasing data, and I did not assume the second question was limited to collaborations with the company. Both of those would be unusual for industry, which typically does not publicly release data but instead makes it available upon request to researchers through a portal without any requirement of collaboration. Perhaps your interpretation is correct, but I can’t conclude that based on what is printed. Anyways, I have asked the authors to clarify, as per your suggestion.
You ask: “Do you think we erred in publishing the results of a life-saving vaccine because the authors do not wish to share the data they paid to generate?”
I agree with the idea of publishing trials irrespective of the direction of their results. In my opinion, the important question is not one of whether to publish, but whether the publication is trustworthy. I can’t answer that question without having access to the data. If the editors, peer reviewers, and readers don’t have any access to the data to verify what was published, how can we know whether what was published was in error or not?
This was a taxpayer funded trial of a global public health intervention, and I think the argument for data secrecy is a weak one. But I was not aiming to suggest that NEJM can force data sharing. I am only suggesting that you have a powerful ability to shine a spotlight on problems in the information architecture here.
Best,
Peter
From: Rubin, Eric erubin@nejm.org
Date: Wednesday, June 2, 2021 at 6:54 AM
To: Doshi, Peter <pdoshi@rx.umaryland.edu>, Longo, M.D., Dan dlongo@nejm.org
Cc: Rowhani-Farid, Anisa <arowhani@rx.umaryland.edu>, Hong, Kyungwan <hong.kyungwan@umaryland.edu>, Letter <letter@nejm.org>
Subject: Re: data sharing by Baden et al
Dear Dr. Doshi,
As you know, ICMJE policy is to encourage but not require data sharing. We ensure that authors to report their data sharing plan but don’t have any enforcement powers beyond that.
In a perfect world, other qualified researchers would have access to deidentified data, a situation which is the norm in the basic science world where my lab operates. But getting there will require the cooperation of researchers and funders and we’re not there yet. For now, it’s the responsibility of the trialists to choose if and when they will share their underlying data.
Eric
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This really does stand out
“Do you think we erred in publishing the results of a life-saving vaccine because the authors do not wish to share the data they paid to generate?”
I am sorry that we will not be able to publish your recent letter to the editor regarding the El Sahly article of 04-Feb-2021. The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received. Many worthwhile communications must be declined for lack of space.
Thank you for your interest in the Journal.
Repeat after me
Dear Mrs. Dressen:
I am sorry that we will not be able to publish your recent letter to the editor. The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received. Many worthwhile communications must be declined for lack of space.
“I am not sure what limits your ability to understand …..
Covid-19 vaccines: In the rush for regulatory approval, do we need more data?
https://www.bmj.com/content/373/bmj.n1244
Our Censored Journals
David Healy, MD, FRCPPsych*
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC3190554/
Questions That This Paper Raises
1. Why are journals apparently unwilling to ensure that publications relating to pharmaceutical products conform to the norms of science in making data available?
2. Why are academic meetings unwilling to ensure that presentations of pharmaceutical company data conform to the norms of science by making data available?
3. Do our medical publications still deserve the sobriquet journals or should they be renamed periodicals?
4. Is it time to rebrand our academic meetings as trade fairs? Even if not entirely given over to marketing, the presence of non-company presentations and material at such meetings helps generate an impression of science that is useful for marketers.
5. Would the marketing departments of pharmaceutical companies prefer the public at large to think that the real issues center on undeclared conflicts of interest or on the failures of journal editors and academic meeting organizers to ensure that journals and meetings are in fact scientific?
Dr. Eric Rubin
“We are never going to learn how safe this vaccine is unless we start giving it.”
Longo’s way of putting things is jaw-dropping …
It’s a Small World https://www.youtube.com/watch?v=7jiaU0xbOKs
Why does Dan Longi refer to the Baden et al report as “the El Sahly article of 04-Feb-2021”?
Could this be to deflect attention from Lindsey R. Baden, MD? Linsey Baden is the first-named author of this report. Lindsey not only works alongside Dan at Brigham and Women’s Hospital in Boston but is also a Deputy Editor at the New England Journal of Medicine.
Dan Longi states (above):
“My interpretation of the “may be available” statement is that interested investigators should contact the authors directly for any requests. It is unfortunate that you find this confusing. I suggest you contact the authors directly”
It is unfortunate that Dan can’t have a word with Lindsey – who as an author of the article presumably has access to the raw data – to find a solution. Otherwise Lindsey Baden’s role in the NEJM might seem an unsurmountable conflict of interest.
To quote Dan again (my parenthesis):
In a perfect [yet small] world, other qualified researchers would have access to deidentified data, a situation which is the norm in the basic science world where my lab operates. But getting there will require the cooperation of researchers and funders and we’re not there yet.”
Can’t he get his colleague to cooperate?
Well spotted. Why El-Sahly? Baden is the first author. This truly is weird. Maybe Long and Baden aren’t on speaking terms and it would stick in his craw to even write the name, even though they both seem Handmaidens (is there a male version of this – perhaps just servants) of Pharma.
D
Memories
Data scientists = research parasites?
https://www.aei.org/articles/data-scientists-research-parasites/
Vinay K. Prasad, MD, a noted hematologist-oncologist, was one outspoken critic of Drazen’s editorial. In an interview with Medscape Medical News, Dr. Prasad pilloried the editorial as being “probably the worst editorial written this year in any journal.”
https://www.biopharmadive.com/news/nejm-editor-drazen-hit-with-big-backlash-over-research-parasites-comments/412784/
Dr. Prasad argued that testing another researcher’s data is not a threat. Rather it is what science needs to move forward. He cites the reanalysis of the data from Genentech’s Tamiflu trials which eventually demonstrated Tamiflu is only marginally effective.
Drazen quickly authored a second editorial which noticeably watered down his criticism of researchers who use data collected by others. “In the process of formulating our policy, we spoke to clinical trialists around the world…Some of them spoke pejoratively in describing data scientists who analyze the data of others…In our view, however, researchers who analyze data collected by others can substantially improve human health,” Drazen wrote.
Priggish NEJM Editorial on Data-sharing Misses the Point it Almost Made
https://science.thewire.in/science/priggish-nejm-editorial-on-data-sharing-misses-the-point-it-almost-made/
However, by saying that the ‘parasites’ may “use the data to try to disprove what the original investigators had posited”, NEJM has crawled into an unwise hole of infallibility of its own making.
Are Made Of This…
The main medical journals are another group of organizations that have crossed the Rubicon. No longer are they performing the function for which they were created. Former editor Richard Smith of the BMJ felt frustrated enough that after he retired he wrote an article about it. [1] Having a large part of their income coming from the pharma industrial complex, they only allow the fringes of skeptical debates to appear on their pages now. So realistically, I think it would be unwise to waist too much time communicating with them, if such time could be better spent elsewhere.
Before getting to Moderna I’ll take a step back. Early in 2020, I watched a live podcast by virologist James Lyons-Weiler discussing with another virologist the surprising number of new mutations the SARS CoV-2 virus had. This lead James to be one of the first to suggest that it had been genetically engineered (built bit by bit) but had changed his mind after finding these sequences already on the Wuhan data base (when it could still be accessed). The main snippet of information I found interesting at the time, was that of all the viral proteins they could have chosen to make a vaccine from, they choose the most pathogenic. This spike protein also had the potential to create problems like autoimmunity and ADE further down the line. [2] As other virologists had also warned about the danger of ADE, I quite expected a lively debate but as soon as the vaccines rolled out, mention of this was only rarely mentioned in the main medical journals and even that was only by a few readers emailing in comments to articles.
Being something of a beginner in virology I wanted to start at the beginning and understand the problems Professor Bengt Fadeel could foresee back in 2012 about this nano delivery technology and the many hurdles which would have to be overcome before it could be used therapeutically. [3] He is a full Professor of Medical Inflammation Research at Karolinska Institutet in Stockholm, and Head of the Molecular Toxicology Unit at the Institute of Environmental Medicine, therefore seemed a good source. In the absence of any ‘authoritative’ discussion of this in any of the main journals I had to dive deeper into google scholar and medRxiv.
This lead to a tin foil hat moment when I found a that a patent expert Dr. David Martin PhD was piecing together together what was already sitting uncomfortably at the back of my mind and being posited by others outside of the MSM and main medical journals. He sounded very convincing and over the last year others have been taking note. This brings us back to Moderna. This and other pharmaceutical companies that use the same licenced nano-lipid technology are all inter connected by other patents too and in a worrying way.
Make up your own mind about Moderna and the other vaccine makers by watching or reading the transcript of David Martin giving testimony at the German Corona Inquiry Committee. He covers so many things that it is difficult to sum it up in a sentence. The other references I have placed here is just to be thorough, so need not be read by you but I do urge you to watch David’s testimony as it serves as the main reason for writing this my post. [4]
David E. Martin testifies at the German Corona Inquiry Committee July 9th, 2021
https://www.youtube.com/watch?v=ihjNDf32_Ac
Transcript:
https://drive.google.com/file/d/19o1BeQa6z9XD58GkYE1e-qiiNbnr5wTz/view
This was in July. Since August, Moderna shares have been steadily declining (despite a $ 1 Bn share buyback starting August 2021) as if the big investors have sensed something is amiss or it could be as Moderna’s CEO says that they over estimated their sales projections but that seems some over estimate. https://www.nasdaq.com/market-activity/stocks/mrna Click for the 1Y graph top right)
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Addendum
On 21 February 2022 a research team published in Frontiers in Virology a hypothesis pointing out the unlikely match between a sequence of spike protein and Moderna’s own patent US patent 9,587003
“Conventional biostatistical analysis indicates that the probability of this sequence randomly being present in a 30,000-nucleotide viral genome is 3.21 ×10−11” they comment. [5]
I imagine getting down into this level of detail for many would be boring. However, I thought I would add this paper for those whom would like to, as Dr Mobeen Syed M.D, MS (who teaches medical students and thus explain things very clearly) has recently given his unbiased views in very easy to understand way regarding this new hypothesis concerning Moderna’s patent which predates the pandemic and its uncanny match with this ‘novel’ SARS CoV-2 virus.
Mobeen Syed. Spike Genes Have Patented DNA Sequences. This is Dangerous.
https://www.youtube.com/watch?v=zPoZTtruaB0
References:
[1] Smith R (2005) Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med 2(5): e138. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC1140949/#pmed-0020138-b1
[2] Pathogenic priming likely contributes to serious and critical illness and mortality in COVID-19 via autoimmunity
https://www.sciencedirect.com/science/article/pii/S2589909020300186?via%3Dihub#sec4
[3] Bengt Fadeel (June 2012) Clear and present danger? Engineered nanoparticles and the immune system
Swiss medical weekly: official journal of the Swiss Society of Infectious Diseases, the Swiss Society of Internal Medicine, the Swiss Society of Pneumology 142:w13609
DOI:10.4414/smw.2012.13609
https://www.researchgate.net/publication/228070910_Clear_and_present_danger_Engineered_nanoparticles_and_the_immune_system
[4] David E. Martin (July 9th, 2021) testifies at the German Corona Inquiry Committee
https://www.youtube.com/watch?v=ihjNDf32_Ac
Transcript:
https://drive.google.com/file/d/19o1BeQa6z9XD58GkYE1e-qiiNbnr5wTz/view
[5] Ambati BK, Varshney A, Lundstrom K, Palú G, Uhal BD, Uversky VN and Brufsky AM (2022) MSH3 Homology and Potential Recombination Link to SARS-CoV-2 Furin Cleavage Site. Front. Virol. 2:834808. doi: 10.3389/fviro.2022.834808
https://www.frontiersin.org/articles/10.3389/fviro.2022.834808/full
[6] Mobeen Syed. Spike Genes Have Patented DNA Sequences. This is Dangerous.
https://www.youtube.com/watch?v=zPoZTtruaB0
Over on DavidHealy, the injuries in vaccine trials post has led to a marvellous new concept that seems completely appropriate here
NEJM-GATE
NEJM-Gate
Addressing Vaccine Inequity — Covid-19 Vaccines as a Global Public Good – NEMJ Editorial 23 Feb 2022
“And a new challenge to the global vaccine supply has emerged: data from multiple in vitro and real-world studies published in the Journal have shown that antibodies to SARS-CoV-2 wane over a matter of months after vaccination, findings that underscore the need for a booster to restore high antibody levels both to reduce infection with new variants and to minimize hospitalization and death.5 In developed countries, the rapid emergence of the omicron variant has increased the urgency of these booster doses. Israel, a front-runner in providing booster doses, is now testing the efficacy of yet a fourth vaccine dose, and further boosters and redesigned vaccines are likely to be needed over time.”
Written by ALL the usual suspects
David J. Hunter, F.Med.Sci.,
Salim S. Abdool Karim, M.B., Ch.B., Ph.D.,
Lindsey R. Baden, M.D.,
Jeremy J. Farrar, M.D., Ph.D.,
Mary Beth Hamel, M.D., M.P.H.,
Dan L. Longo, M.D.,
Stephen Morrissey, Ph.D., and
Eric J. Rubin, M.D., Ph.D.
United they may stand but how can this gang claim credibility and editorial independence when they ALL have such a pro-vaccine stance. Divided they will fall; and the bigger they are, the harder they fall.
Longo, “It’s not our job to get data revealed. Simply beleeeve what we publish.”