Resignation in protest, Frontiers in Pharmacology Topic Editors, “Treating COVID-19
With Currently Available Drugs”

To: Frontiers Chief Executive Editor, Manager | Frederick Fenter
Frontiers in Pharmacology, Respiratory Pharmacology Chief Editor, Prof. Paolo Montuschi
Frontiers Director of Publishing Operations | Judyta Sorokowska-Yammin
Frontiers Head of Research Integrity, London Office | Elena Vicario, PhD
Topic Authors

From: Guest Editors:
Prof. Maria Cristina Albertini
General Pathology (MED04)
Department of Biomolecular Sciences (DISB)
University of Urbino Carlo Bo
Via Sffi 2, 61029 URBINO (PU)

Prof. Piero Sestili
Pharmacology
Department of Biomolecular Sciences (DISB)
University of Urbino Carlo Bo
Via “I Maggetti” 26, 61029 URBINO (PU)

Dr. Robert Malone, MD, MS
Principal Consultant
RW Malone MD LLC
Madison, VA 22727 USA

Dr. Howard Haimes, PhD.
Preclinical Scientist – Pharmacology & Toxicology

Subject Matter Expert A&AS

Support to DTRA, SAIC

 

23rd April 2021

Dear Dr. Fenter, Ms. Sorokowska-Yammin, Dr. Vicario, Prof. Montuschi, Topic Authors,

It is with sincere regret that we write at this time to resign from our roles as founding topic
editors for the Frontiers in Pharmacology Research Topic “Treating COVID-19 With Currently
Available Drugs”. Since developing this topic and associated justification documents and
applying to and receiving permission to proceed with this special topic volume from “Frontiers
in Pharmacology“ for publication under the “Frontiers in Pharmacology (Respiratory
Pharmacology)” we have invested many hundreds of volunteer hours in soliciting manuscript
submissions, identifying reviewers for submitted manuscripts, and managing the peer review
process. We took this action not for any commercial gain, but rather to address an unmet need.
This has been done in full and careful compliance with all “Frontiers” criteria, and with approval
by “Frontiers”.

The Topic had been created with the aim to contribute to identification of better and more
effective pharmacological treatments during the COVID-19 pandemic by suggesting repurposed
drugs. Our goal has been to reduce the barriers to publishing earlier stage clinical research
regarding repurposed drugs, and in this way help reduce the terrible burden of global death
due to COVID-19. While awaiting development of herd immunity (during vaccination), we
wanted to contribute in COVID-19 therapy. In proposing the guest topic, we noted that
Frontiers purports to provide rapid review, and explicitly allows publication of earlier stage
clinical research findings including case series reports. CVs of each guest editor and the Topic
proposal were accepted after evaluation and Mr. Nathan Watkins was assigned by the Frontiers
organization to support the guest editors.

The recent extraordinary and unprecedented actions by Frontiers in the rejection of the review
manuscript “REVIEW OF THE EMERGING EVIDENCE DEMONSTRATING THE EFFICACY OF
IVERMECTIN IN THE PROPHYLAXIS AND TREATMENT OF COVID-19” and the original research
manuscript “HOSPITALIZED COVID-19 PATIENTS TREATED WITH CELECOXIB AND HIGH DOSE
FAMOTIDINE ADJUVANT THERAPY SHOW SIGNIFICANT CLINICAL RESPONSES” after review and
acceptance of each manuscript by four/five well qualified peer reviewers (during final
validation) is what has prompted our collective resignation.

To place this into context of the Frontiers review process, the papers have been rejected during
the final validation phase, having previously passed the evaluation (peer review) phase. In
general, the Frontiers review process consists of the following steps: initial validation, editorial
assignment, independent review, interactive review, review finalized (acceptance/rejection),
final validation (this last step is the final editorial review decision prior to invoicing and finalizing
manuscript proofs before actual publication). The initial validation step performed by Frontiers
is independent of the Guest Editors’ evaluation and is performed prior to editorial assignment
to Guest Editors. Guest Editors are then asked to look for reviewers for independent review
and manage interactive review. Review is finalized by guest Editors but the final validation
depends on Frontiers decision.

Since approval of the special topic, Mr. Watkins stopped communicating with the guest editors.
After some time and multiple inquiries, we were told that he had left Frontiers, and that no
replacement had been assigned. Since Nathan Watkins disappeared, as Guest Editors, we have
had to go “on strike” to receive an answer to emails sent or telephone messages left for
requests of information. After a couple of weeks we finally had the possibility to interact with
Frontiers Chief Executive Editor (Manager) Dr. Frederick Fenter (and subsequently with Judyta
Sorokowska-Yammin).

After Dr. Fenter unilaterally rejected the ivermectin review manuscript after it has completed
peer review, all of the pending manuscripts associated with the special topic were placed on
hold with executive “quality” review. Most were eventually released and allowed to proceed
through the review and publication process. In the case of the celecoxib and high dose
famotidine case series (which had also completed peer review), the hold was continued and
then the manuscript unilaterally rejected by the specialty editor for the Respiratory section of
Frontiers in Pharmacology (Prof. Paolo Montuschi). The authors appealed this unilateral
rejection. Since Dr. Fenter perceived an abnormal evaluation process, he agreed with us to
reactivate the review of the manuscript (11/03/2021) and tried his best to interact with guest
editors to find a final positive conclusion. After different calls, additional review by external
reviewers (added to the previous ones), and determination that the rationale for rejection by
Prof. Montuschi was without merit, we were informed that the specialty Chief Editor had again
insisted that the paper not be published. Frontiers senior management then informed us that
to have the paper published we had to submit it in another section of Frontiers Journal
(maintaining all the reviewers positive evaluation). Finally, in another Frontiers section, the
paper could be accepted. This is inconceivable! We believe in our scientific integrity, and would
like to protect scientific integrity of each authors who submitted (or are submitting) their
papers. This process described above took nearly 5 months (and was stopped in the “review
finalized” stage for nearly 2 months!). At this point, we decided to close the topic if any solution
was not found before 16/04/2021 (another ultimatum we had to apply to receive an answer) to
have the paper published in the topic. On 15/04/2021 the paper has been formally rejected .
Dr. Fenter formally evidenced that the paper could only be published in another section of the
journal indicating that for our topic the different Frontiers’ policies are applied and ethical
science is not respected. Soon after (16/04/2021), Dr. Fenter informed Prof. Maria Cristina
Albertini (part of the Review Editor board in the section “Experimental Pharmacology and Drug
Discovery “) that the “term as Review Editor in the section Experimental Pharmacology and
Drug Discovery will end on May 16, in accordance with our Terms and Conditions” since it has
become apparent that we do not agree on editorial procedures and need for quality control
for published articles, accordingly to Frontiers’ policies. Prof. Maria Cristina Albertini never
had problems with editorial procedures in “Experimental Pharmacology and Drug Discovery “
section.

Are Frontiers policies applied differently in the different sections? Why could the paper be
published in a section different from “Respiratory pharmacology”?
To provide additional detail, in the instance of the second rejection of the original manuscript,
after three months in peer review, and again gaining acceptance by four well qualified peer
reviewers, the journal elected to Prof. Paolo Montuschi (Specialty Chief Editor, Frontiers). The
review of that special reviewer was final; not subject to appeal or response by the authors.

The rationale provided for rejection was stated as follows:

“The manuscript could not be sufficiently revised by the authors to address the concerns
raised by the reviewers or editor during the review process.
This manuscript deals with very preliminary clinical data, it is essentially a case series
report, yet it is presented as original research. The patients in this case series all
received vitamin C and zinc which is not the standard of care, therefore we are unable
to untangle any effect of famotidine and celecoxib from that of vitamin C and zinc. The
paper then goes on to suggest that famotidine and celecoxib are beneficial in COVID-19,
given the fact that patients were taking vitamin C and zinc, plus the lack of controls,
such generalized statements have no place in this article. Therefore we must proceed to
reject this manuscript. We do not exclude that celecoxib or famotidine or both can be
efficacious in COVID-19 treatment, but the present study do not provide sufficient
evidence for that.”

The journal elected to implement an ad-hoc and arbitrary final “super review” by a reviewer
with no specialty experience or training relevant to the manuscript scope. In this case, the
assertions were demonstrably false or incorrect. 1) Each of the four peer reviewers accepted
the manuscript for publication. The independent journal appointed editor Giuseppa Pistritto
never corresponded with the authors in any form about any topic. 2) The manuscript was
clearly and explicitly described as a case series, and this clinical evaluation (case series) is
explicitly allowed for publication both as a general category for this journal and in this special
topic volume. 3) Administration of Vitamin C and Zinc are, in fact, standard of care in many US
hospitals for treatment of COVID-19, and specifically is standard of care at Beloit Memorial
Hospital where this case series arises. 4) Regarding controls, this manuscript describes a
retrospective case series. Case series do not include internal controls. Reference laboratory
bioassays widely accepted and previously published which correlate with typical outcomes
were explicitly provided for all patients in this case series. 5) The principal conclusion was not as
the reviewer states, but rather that these data provide justification for initiation of randomized
clinical trials to assess this combination of agents – which trials are either currently enrolling or
have been funded and are in late stage planning. We note that the language used in the
rejection rationale provided by Prof. Paolo Montuschi to Drs. Tomera, Malone and Kiddah
mirrors that of the rejection letter provided to Dr. Kory and colleagues, which appears to
suggest that Prof. Montuschi was adapting and paraphraising language provided to him by the
journal for a pre-planned rejection rationale.

In a final chapter of this unfortunate history, Prof. Albertini and Sestili were able to obtain
agreement with Frontiers leadership for a final Zoom meeting to discuss what has taken place
and seek some sort of mutually agreeable accommodation which might salvage the situation.
This final Zoom meeting took place on April 19 between Prof. Albertini, Dr. Fenter, Dr. Johnson
Prof. Sestili and Dr. Sorokowska in which we unsuccessfully tried to find a solution. Prof. Sestili
wrote to Prof. Montuschi (after he had been invited many times by us to discuss the above
problems) communicating that the Guest Editors were nearly to resign and again – but this time
as a simple colleague – asked for an explanation of the entire story. As Italian citizens, both Prof.
Albertini and Sestili are embarrassed by the enduring silence and avoidance of confrontation of
Prof. Montuschi. The Guest Editors suggest that this repeated very unpolite behavior calls into
question the scientific authoritativeness, impartiality and credibility of Dr. Montuschi as the
lead editor for the respiratory branch of Frontiers in Pharmacology, and consequently that of
the Frontiers organization.

Upon reviewing these events, some might conclude that the journal is practicing extraordinary
and unprecedented censorship of fully peer reviewed manuscripts. The rationale for doing so is
speculative, and the journal has communicated that these actions are justified by the following
considerations:

  • 1) “The papers considered for publication in this Research Topic will require more specific
    oversight, as the subject and aim of the collection has an important involvement with
    the ongoing public health crisis. Frontiers aims for editorial independence while also
    being ultimately responsible for all article publications. We need to anticipate potential
    impact on the population and maintain standards of rigour for our Journals and the
    scientific record overall.

 

  • 2) “Moving forward, the Editorial Office will continue to monitor submissions to this topic.
    Articles will be screened at submission, with the support of our Specialty Chief Editor, to
    ensure that all articles submitted are valid, and fulfil our acceptance criteria. We ask
    that, as you continue to act as Handling Editors for articles, you remain vigilant and
    ensure that any serious recommendations for rejection are addressed swiftly. These
    steps, combined with increased awareness and participation from all parties involved,
    will help ensure the recent situation around the ivermectin paper is not repeated. We
    hope that you understand the rationale behind these additional measures, which are in
    place in the interest of maintaining scientific integrity, both for your collection, and
    Frontiers in Pharmacology as a journal.”

 

The Guest editors reject any assertion that scientific integrity was compromised or breached
during the review process for either of these submissions, or that this special edition has not
been managed with full integrity, except in the case of the unethical breach of the journal itself
and its senior management in performing an extraordinary, arbitrary and capricious post-peer
review process.

At this point, based on these many actions, we are unable to assure scientific integrity of the
peer review process on the part of the journal for this special topic. Our time and that of the
peer reviewers has been donated to the journal, and our reputations used without
compensation. We ask to be removed from association with this special topic area, that an
apology be issued to ourselves and our respective institutions for the actions of the journal in
this matter, and that the special topic (which we had developed with full approval by the
journal) be discontinued effective immediately. Having communicated to Frontiers that this
would be our collective action if corrections were not made to this extraordinary re-review
process, Frontiers has elected to expel each of the guest editors from any ongoing or future role
as editors, and to close down and wipe all electronic evidence that the special topic had ever
even been approved or had manuscripts submitted under the topic approved. This decision
was disclosed in email communications with all corresponding authors of published, approved,
or pending manuscripts, but not with the guest editors who had created the topic and solicited
and managed review of the manuscripts.

The scientific process requires fair, open, and transparent peer review to proceed effectively
and efficiently – particularly at this time and for this topic. The actions of “Frontiers” in this
matter clearly violate well established norms and processes for peer review and publication of
scientific works and intellectual contributions, and instead have substituted a unilateral,
arbitrary, and capricious process. On behalf of our peers, our institutions, and our scientific and
medical colleagues we cannot allow this precedent to remain unchallenged. In our opinion,
these unfortunate events constitute gross editorial misconduct by “Frontiers”.

Best regards,

Prof. Maria Cristina Albertini

Prof. Piero Sestili

Dr. Robert Malone, MD, MS Dr.

Howard Haimes, PhD.

Comments

0 Comments

Submit a Comment