CORMAN-DROSTEN REVIEW REPORT

CORMAN-DROSTEN REVIEW REPORT

CURATED BY AN INTERNATIONAL CONSORTIUM OF SCIENTISTS IN LIFE SCIENCES (ICSLS)

Retraction Request Letter to Eurosurveillance Editorial Board

With commentaries by Robert Gorter, MD, PhD.

November 28th, 2020

 

Robert Gorter:

Here follows the text of the request to retract the article by Corman & Drosten et al. because of all its scientific flaws (at least 10 identified) but the publishers named (the “Eurosurveillance”) refused with the main argument that at the time of the publication there were many facts unknown yet and that from the point of Drosten and his co-authors it was reasonable to come with their reasoning. This is new in science that wrong data are not corrected later on. This is (in my opinion) a clear act of protection of other interests than publishing the Truth.

One could compare this attitude with Science of the 1600’s when the generally accepted believe (“science”) was that the earth is flat and hat the sun orbits the earth. If the Eurosurveillance stands by Coman & Drosten’s publication with this argument then the Eurosurveillance must also support the science that the earth is flat.

Since 1995, Eurosurveillance has tried to provide the European public health community with an open-access platform to exchange relevant findings on communicable disease surveillance, prevention and control. A weekly, electronic, peer-reviewed publication, Eurosurveillance aims to provide timely facts and guidance for public health professionals and decision-makers in the field of infectious disease to facilitate the implementation of effective prevention and control measures.

This is the retraction-request letter sent to Eurosurveillance by the main & co-author’s, written by Dr. Peter Borger, enclosed to the extended Review Report submission via the Eurosurveillance online-submission portal. Submission date was 27th of November, 2020.

Nov 26th 2020,

To: Editorial Board Eurosurveillance / European Centre for Disease Prevention and Control (ECDC) / Gustav III:s Boulevard 40 / 16973 Solna / Sweden

Subject: External Review and request to retract the paper of Corman et al, published in Eurosurveillance January 23, 2020.

Dear editorial board Eurosurveillance,

We, an international consortium of life-science scientists, write this letter in response to the article “Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR” published in Eurosurveillance (January 23rd, 2020) and co-authored by Victor M Corman , Olfert Landt , Marco Kaiser , Richard Molenkamp, Adam Meijer, Daniel KW Chu, Tobias Bleicker , Sebastian Brünink, Julia Schneider , Marie Luisa Schmidt , Daphne GJC Mulders , Bart L Haagmans , Bas van der Veer , Sharon van den Brink, Lisa Wijsman, Gabriel Goderski, Jean-Louis Romette, Joanna Ellis, Maria Zambon, Malik Peiris, Herman Goossens, Chantal Reusken, Marion PG Koopmans, and Christian Drosten.

This paper (hereafter referred to as “Corman-Drosten paper”), published by “Eurosurveillance” on 23 January 2020, describes an RT-PCR method to detect the novel Corona virus (also known as SARS-CoV2). After careful consideration, our international consortium of Life Science scientists found the Corman-Drosten paper is severely flawed with respect to its biomolecular and methodological design. A detailed scientific argumentation can be found in our review “External peer review of the RTPCR test to detect SARS-CoV2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results”, which we herewith submit for publication in Eurosurveillance.

Further, the submission date and acceptance date of this paper are January 21st and January 22nd, respectively. Considering the severe errors in design and methodology of the RT-PCR test published by “Eurosurveillance”, this raises the concern whether the paper was subjected to peer-review at all.

A previous request from our side (Dr. P. Borger; email 26/10/2020) to the editors of “Eurosurveillance” to provide the peer review report of the Corman-Drosten paper has not been complied with. We have enclosed your email reply (dated 18/11/2020) indicating that you do not wish to disclose important information to solve this conundrum.

We are confident that you will take our scientific objections seriously and recognize that there is no alternative but to accept our request to retract the Corman-Drosten paper.

Sincerely,

Dr. Pieter Borger (MSc, PhD), Molecular Genetics, W+W Research Associate, Lörrach, Germany

Prof. Dr. Ulrike Kämmerer, specialist in Virology / Immunology / Human Biology / Cell Biology, University Hospital Würzburg, Germany

Prof. Dr. Klaus Steger, Department of Urology, Pediatric Urology and Andrology, Molecular Andrology, Biomedical Research Center of the Justus Liebig University, Giessen, Germany

Prof. Dr. Makoto Ohashi, Professor emeritus, PhD in Microbiology and Immunology, Tokushima University, Japan

Prof. Dr. med. Henrik Ullrich, specialist Diagnostic Radiology, Chief Medical Doctor at the Center for Radiology of Collm Oschatz-Hospital, Germany

Rajesh K. Malhotra (Artist Alias: Bobby Rajesh Malhotra), Former 3D Artist / Scientific Visualizations at CeMM – Center for Molecular Medicine of the Austrian Academy of Sciences (2019-2020), University for Applied Arts – Department for Digital Arts Vienna, Austria

Dr. Michael Yeadon BSs (Hons) Biochem Tox U Surrey, PhD Pharmacology U Surrey. Managing Director, Yeadon Consulting Ltd, former Pfizer Chief Scientist, United Kingdom

Dr. Kevin P. Corbett, MSc Nursing (Kings College London) PhD (London South Bank) Social Sciences (Science & Technology Studies) London, England, UK

Dr. Clare Craig MA, (Cantab) BM, BCh (Oxon), FRCPath, United Kingdom

Kevin McKernan, BS Emory University, Chief Scientific Officer, founder Medical Genomics, engineered the sequencing pipeline at WIBR/MIT for the Human Genome Project, Invented and developed the SOLiD sequencer, awarded patents related to PCR, DNA Isolation and Sequencing, USA

Dr. Lidiya Angelova, MSc in Biology, PhD in Microbiology, Former researcher at the National Institute of Allergy and Infectious Diseases (NIAID), Maryland, USA

Dr. Fabio Franchi, Former Dirigente Medico (M.D) in an Infectious Disease Ward, specialized in “Infectious Diseases” and “Hygiene and Preventive Medicine”, Società Scientifica per il Principio di Precauzione (SSPP), Italy

Dr. med. Thomas Binder, Internist and Cardiologist (FMH), Switzerland

Dr. Stefano Scoglio, B.Sc. Ph.D., Microbiologist, Nutritionist, Italy

Dr. Paul McSheehy (BSc, PhD), Biochemist & Industry Pharmacologist, Loerrach, Germany

Dr. Marjolein Doesburg-van Kleffens, (MSc, PhD), specialist in Laboratory Medicine (clinical chemistry), Maasziekenhuis Pantein, Beugen, the Netherlands

Dr. Dorothea Gilbert (MSc, PhD), PhD Environmental Chemistry and Toxicology. DGI Consulting Services, Oslo, Norway

Dr. Rainer Klement, PhD. Department of Radiation Oncology, Leopoldina Hospital Schweinfurt, Germany

Dr. Ruth Schrüfer, PhD, human genetics/ immunology, Munich, Germany,

Dra. Berber W. Pieksma, General Practitioner, The Netherlands,

Drs. Jan Bonte (GJ), Consultant Neurologist, the Netherlands, Dr. Bruno

  1. Dalle Carbonare (Molecular biologist), IP specialist, BDC Basel,

Switzerland

 

The consequences of false positives

Guest-Article by Howard Steen & Saji Hameed

Part 1 – Background (Howard Steen)

It seemed in January 2020 that the world was facing an impending epidemic caused by a deadly new virus and that a swift response based on inevitably limited data was of the utmost importance to avert a potential global catastrophe. One of the most important tools in this fight to detect, isolate and suppress the virus is the PCR test. The Charité Institute of Berlin led by Prof. Drosten was quick to recognize the extreme seriousness of the situation and developed the first PCR test protocol to detect the SARS-CoV-2 virus in record time. This was simultaneously selected and recommended by the WHO and became the global first line of defense.

Eleven months into the pandemic we have now learned much more about the virus and the multitude of PCR test variants made possible by the Corman-Drosten protocol. Flaws in the test protocol have become increasingly clear and our review report addresses these tremendous concerns.

Additionally alarming, and especially pertinent to this argument, as the PCR test has impacted all levels of global society as perhaps no test has ever done before, are the unforeseen consequences caused by the rise in PCR cases. Over one hundred governments have used these results to apply unprecedented measures to control transmission; such as lockdowns which have irreparably impacted millions of lives and livelihoods and direct attacks on people’s basic rights and personal freedoms, further resulting in catastrophic damages for entire economies.

Part 2 – Consequences (Saji Hameed)

In the literature of PCR testing, it is known that there are many dangers, such as operational false positives that can lead to misinterpretation of the test results. For this reason it is recommended by Kurkela et al. [1] that PCR should only ever be used in tandem with a clinical diagnosis of infection based on symptoms. Finally, there are documented occurrences of misinterpretation that have led to phantom pandemics, e..g. the 2004-2006 Respiratory illness outbreak mistakenly attributed to Pertussis via use of PCR testing [2].

Note that these dangers are multiplied by the promoted industrial scale use of PCR for whole population screening. To put this in perspective, the CD paper describes how 4 out of 310 tests returned false positives (i.e. a rate of 1.2%) in the controlled and first class expert laboratory facilities of the Chariteé Institute.  Applied on the recent status in the USA (Nov 21, 2020 CDC report with total tests performed at 178.1 million) this equates to falsely labelling at least 2.3 million people as ‘infected with Covid-19’ with all the ensuing consequences. But in light of the errors presented in the previous section, the actual false positive rate is unknown and therefore 2.3 million must be considered a minimum estimate; so the distressing reality is likely to be much greater.

  1. The amount of PCR testing increases every day with consequent record numbers of PCR positives. Governments and news organizations cite these daily and use them to justify their individual policies. Some of the consequences of these policies are listed below: Misdiagnosis of PCR positives as infections has a history of causing ‘Casedemics’ which are typically characterized by an incongruity between positive PCR test results and deaths. A fairly recent example was the Swine flu outbreak of 2009 [3];
  2. Blanket Lockdowns have been universally implemented and in many cases extended indefinitely by governments without prior due diligence cost / benefit analysis. The wide ranging and disastrous impacts of these non-evidence based measures are now becoming only too clear: Human impacts, to name just a few include; a) impacts on mental health including an increase in suicides [4]; b) cancelled or delayed essential hospital treatment (e.g. cancer, heart disease, diabetes etc), c) deaths among the elderly due to separation from loved ones, d) inhumane confinement and isolation of the elderly at a stage in their life when they need family contact most, increase in stillborn deaths.

Economic impacts are no less devastating;

  1. a) Lockdowns have created an initial financial disaster already assessed as being of 3-4 times greater impact than the 2008 financial crisis while longer term effects are unknown [5];
  2. b) Loss of future opportunities for the young generation has been highlighted by UNICEF [6];
  3. c) The Word Bank has stated that due to the pandemic measures 88-115 million people will be forced into extreme poverty in 2020 with the total rising to 150 million by 2021 [7];
  4. The use of lockdowns and belief in unproven NPIs coupled with the appearance of the ‘casedemic’ phenomena enabled by PCR testing has encouraged governments worldwide to intimidate their populations into compliance with increasingly bizarre and illogical restrictions. Use of psychological techniques to enforce these includes; a) the deliberate ramping up of fear tactics via the media to ensure compliance, b) excessive use of police and military force to instill an atmosphere of imminent threat to life, c) suggestions of dire consequences of non-compliance to instill fear even including suggestions to children that they might infect and kill their granny, d) The UN has warned of the tendency of some governments to use the emergency declarations as a cover for repressive action [8];
  5. Loss of democracy and human rights: Many human rights as enshrined in Articles of the 1948 UN Universal Declaration [9] of Human Rights are being eroded or simply ignored as a direct result of new lockdown measures justified by PCR test results. The list includes; a) freedoms to protest, b) freedom of thought and speech (Article 18) e.g. prominent scientists censored for expressing opinions and ideas, c) freedom of the press, d) freedom to socialize, e) right to conduct economic business, f) denial of consumer choice, g) limitations on access to education, h) limitations on access to medical treatment / choice, Inhumane treatment (Article 5) e.g. elderly being abandoned and left to alone to die in care institutions.

Par 3 – Conclusion (Howard Steen)

The PCR test on its own is able to find a needle in a haystack by just finding a part of the needle. However, it is important to recognize its limitations: it is useless as a diagnostic test for use in public health laboratory settings.

How will we protect the lives of millions of people at stake here? Is it not our responsibility that we make the right choices even if that means correcting early mis-steps?

This seems to be a pivotal moment and the eyes of history are upon us. Does it not behoove us to face this time with humility and to be conscious of the legacy we leave behind?

In light of our re-examination of the test protocol to identify SARS-CoV-2 described in the Corman-Drosten paper we have identified concerning errors. How can the continuing use of the test protocol be justified after these findings? Furthermore, with knowledge of the misuse and misinterpretation of test results on a global arena, should we not be mindful of this test’s contribution to these terrifying consequences?

The decision as to which test protocols are published and made widely available lies squarely in the hands of Eurosurveillance. A decision to recognize the errors apparent in the CD paper has the benefit to greatly minimize human cost and suffering going forward. Is it not in the best interest of Eurosurveillance to retract this paper?

 

References

[1] Kurkela, Satu, and David WG Brown. “Molecular-diagnostic techniques.” Medicine 38.10 (2009): 535-540.

[2] Outbreaks of Respiratory Illness Mistakenly Attributed to Pertussis — New Hampshire, Massachusetts, and Tennessee, 2004–2006

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5633a1.htm

[3] 2009 press Releases. Health Protection Agency (UK). 24th December 2009. Archive: https://web.archive.org/web/20091224065403/http://www.hpa.org.uk/HPA/NewsCentre/NationalPressReleases/2009PressReleases/

[4] BBC, COVID-19: Lockdown had Major Impact on ‘Mental Health’:

https://www.bbc.com/news/health-54616688

[5] Economic Consequences of COVID-19: https://www.copenhageneconomics.com/dyn/resources/Publication/publicationPDF/0/530/1585835646/copenhagen-economics_economic-consequences-covid-19.pdf

[6] Coronavirus: UNICEF warns of ‘lost generation’ as virus hits children’s services: https://www.dw.com/en/coronavirus-unicef-warns-of-lost-generation-as-virus-hits-childrens-services/a-55657691

[7] COVID-19 to Add as Many as 150 Million Extreme Poor by 2021: https://www.worldbank.org/en/news/press-release/2020/10/07/covid-19-to-add-as-many-as-150-million-extreme-poor-by-2021

[8] COVID-19: States should not abuse emergency measures to suppress human rights – UN experts:

https://www.ohchr.org/EN/NewsEvents/Pages/DisplayNews.aspx?NewsID=25722

[9] Universal Declaration of Human Rights:

https://www.un.org/en/universal-declaration-human-rights/

 

Response to retraction request and allegations of misconduct and scientific flaws

On 27 November 2020, the Eurosurveillance editorial office was made aware of concerns and a request to retract the article ‘Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR’ by Corman et al., published on 23 January 2020.

Allegations concerned the scientific quality of the article, the peer review process and a conflict of interest for two of the authors, who are also editorial board members of Eurosurveillance. The authors of the article and Eurosurveillance’s editorial board were informed about these claims on 2 December and 3 December 2020, respectively. On 3 December 2020, an editorial note was published stating that the Eurosurveillance editorial team would investigate the matter following the journal’s existing procedures and in consultation with experts [1]. The two co-authors of the article in question who are associate editors on Eurosurveillance’s editorial board were excluded from all related proceedings.

An initial evaluation of the allegations was undertaken in collaboration with several board members, followed by a discussion at the annual editorial board meeting on 4 December 2020. This resulted in the decision that it was not necessary to publish an expression of concern with respect to allegations of scientific misconduct or fraud, and that there was no conflict of interest by the associate editors who co-authored the manuscript. It was further decided to involve external subject experts to assess the allegations related to the scientific content of the article.

Members of the Eurosurveillance editorial board may submit manuscripts to the journal, in keeping with the policies of many other respected scholarly journals. However, articles submitted by members of the board are not given any priority over other manuscripts. When editorial board members are authors of a submitted manuscript, they are not involved in any stage of the peer review or the editorial decision-making, nor do they have access to confidential information related to the decision-making process. Whether or not authors are members of the editorial board has no bearing on editorial consideration, nor any effect on the editorial evaluation (https://www.eurosurveillance.org/evaluation) or review (https://www.eurosurveillance.org/for-reviewers) processes, which are implemented as described on the journal’s website. These principles were followed for the article by Corman et al., which was authored by 24 virologists and laboratory experts in six different countries; additionally, the editorial board of Eurosurveillance confirmed that when these principles are applied, being a board member does not constitute a conflict of interest. The journal has rejected articles submitted by board members on many occasions.

Eurosurveillance has a confidential peer review process and a policy of double-blind peer review, in which both the authors’ and the reviewers’ identities are confidential. Peer review reports are not made publicly available and are considered internal documents intended solely to guide editorial decision-making. Sharing reviewer reports with third parties would violate the assumed confidentiality obligations for journals that apply this peer review model, as per the International Committee of Medical Journal Editors [2] and the World Association of Medical Editors [3].

Following the allegations raised, all associate editors—except for the two co-authors of the article in question who are associate editors—were given access to the full documentation of the evaluation and review process the article underwent. This enabled them to confirm that the reviews were conducted in full and by independent experts.

The article by Corman et al. was fast-tracked and was reviewed by two independent experts in the field. The editorial team decided that this submission warranted quick consideration in the context of an exceptional and rapidly evolving public health situation and a need to enable laboratories to detect the newly emerged virus. When the article was submitted, the situation in Hubei province, China, had evolved massively. Several cases of what was later named coronavirus disease (COVID-19) had been imported to other countries and China had taken unprecedented, large-scale measures to stop virus spread. Thus, after a pre-submission enquiry—a common practice for scholarly journals—we contacted potential peer reviewers who agreed to stand by to review the submission should it pass the initial screening conducted by the editorial team. The reviewers kindly picked up their assignments immediately and submitted their overall positive verdicts hours after submission. The authors were also asked to stand by, as the editors would need them to be available on short notice to reply to the reviewers’ comments and to respond to editorial queries and comments. All parties worked intensely, including outside the usual working hours, on the finalisation of the submission.

The speed of the publishing process has led to allegations via social media and email that the evaluation and review process were flawed. The Eurosurveillance editorial team has long-standing experience in expedited publishing in instances when rapid dissemination of information could potentially lead to a prompt change in an ongoing public health situation or create awareness for topics of timely relevance. In such instances, the editorial team works in close coordination with reviewers and authors. Since 2015, about 30% of rapid communications have been published less than 2 weeks following submission, including peer review. This has also been the case for a maximum of two regular articles per year. Eurosurveillance’s in-house editorial team performs most editorial and all publishing tasks, without involvement of external parties such as typesetters. This allows for great flexibility, particularly in times of emerging or evolving public health emergencies [4–6], when case numbers or other relevant information/data can be updated even hours before publication.

Expedited review does not necessarily affect the filtering function of peer review, nor does it compromise reviewers’ ability to critically assess the content, validity and quality of a paper. The article by Corman et al. is a methodological paper describing the setup and validation of a PCR-based workflow that would enable laboratories to detect the then novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As pointed out in an accompanying editorial note on 23 January 2020 [7], the primers and probes and a brief description had already been made available in the form of a World Health Organization Interim Guidance document [8], while the article further elaborated on the details of the validation in five different international laboratories.

Of note, the 23 January 2020 issue also contained an article by Wu et al. that assessed the epidemiological characteristics of COVID-19 infections [9], for which we were able to secure an equally fast peer review.

The detailed allegations with respect to scientific flaws in the Corman et al. article were reviewed by a group of five laboratory experts. These comments were made available to the Eurosurveillance associate editors, except for those who were co-authors of the paper.

The consulted experts confirmed that the Corman et al. article was scientifically adequate for its purpose and for the limited data and material available at this early stage in the COVID-19 pandemic. Any laboratory deciding to use the primers and protocol suggested in this article would ascertain the assay for its fitness for purpose and compliance with local quality and accreditation requirements; this is what has happened worldwide since the publication of the article. With more data and evolving knowledge, laboratories have since further improved the initial method, as per usual practice.

In conclusion, after a thorough investigation in which we collected scientific advice from various sources, including several external reviewers, the editorial team—unanimously supported by its associate editors, except for those who were involved as co-authors—has decided that the criteria for a retraction of the article have not been fulfilled.

References

Eurosurveillance editorial team. Editorial note. Euro Surveill. 2020;25(48):2012031.  https://doi.org/10.2807/1560-7917.ES.2020.25.48.2012031

International Committee of Medical Journal Editors (ICMJE). Recommendations. Philadelphia: ICMJE; 2019. Available from: http://www.icmje.org/recommendations

World Association of Medical Editors (WAME). Recommendations on Publication Ethics Policies for Medical Journals: Peer Review. WAME. [Accessed: 01 Feb 2021]. Available from: http://wame.org/recommendations-on-publication-ethics-policies-for-medical-journals#Peer%20Review

Scheutz F, Nielsen EM, Frimodt-Møller J, Boisen N, Morabito S, Tozzoli R, et al. Characteristics of the enteroaggregative Shiga toxin/verotoxin-producing Escherichia coli O104:H4 strain causing the outbreak of haemolytic uraemic syndrome in Germany, May to June 2011. Euro Surveill. 2011;16(24):19889.  https://doi.org/10.2807/ese.16.24.19889-en  PMID: 21699770

Kageyama T, Fujisaki S, Takashita E, Xu H, Yamada S, Uchida Y, et al. Genetic analysis of novel avian A(H7N9) influenza viruses isolated from patients in China, February to April 2013. Euro Surveill. 2013;18(15):20453. PMID: 23594575

MacDonald E, Steens A, Stene-Johansen K, Gillesberg Lassen S, Midgley S, Lawrence J, et al. Increase in hepatitis A in tourists from Denmark, England, Germany, the Netherlands, Norway and Sweden returning from Egypt, November 2012 to March 2013. Euro Surveill. 2013;18(17):20468. PMID: 23647624

Eurosurveillance editorial team. Note from the editors: novel coronavirus (2019-nCoV). Euro Surveill. 2020; 25(3):2001231.  https://doi.org/10.2807/1560-7917.ES.2020.25.3.2001231

World Health Organization (WHO). Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases. Geneva: WHO; 2020. Available from: https://www.who.int/health-topics/coronavirus/laboratory-diagnostics-for-novel-coronavirus

Wu P, Hao X, Lau EHY, Wong JY, Leung KSM, Wu JT, et al. Real-time tentative assessment of the epidemiological characteristics of novel coronavirus infections in Wuhan, China, as at 22 January 2020. Euro Surveill. 2020;25(3):2000044.  https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000044  PMID: 31992388

 

 

 

 

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