Statement of Concern and Request for Retraction: Clinical Infectious Disease’s Acceptance of “Roman et al.”

Statement of Concern and Request for Retraction: Clinical Infectious Disease’s Acceptance of “Roman et al.”

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

We have sent an Open Letter to the Editor-in-Chief of the journal “Clinical Infectious Disease” to recommend an investigation and consequent retraction of a highly problematic meta-analysis titled “Ivermectin for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials” Re: Roman Y M, Burela P A, Paspuleti V, Piscoya A, Vidal J E and Hernandez A V (“Roman et al.). There are a number of identified, material concerns associated with this study that merit the imminent escalation to the journal’s leadership.

An “Accepted Manuscript” in Clinical Infectious Diseases, Roman et al. does not meet the standards of accuracy and integrity that any learned journal should demand. In asserting Conclusions that are not defensible on the evidence presented, it makes no contribution to science or medicine. In its present form, it should be retracted.

Unscrupulous Campaign Against Mounting Ivermectin Evidence

The irony in the authors’ point of view cannot be ignored while they declared:

“in the context of a misinformation infodemic, the dissemination of these results caused confusion for patients, clinicians (in particular those without training in critical reading of the scientific literature) and decision-makers, who may manipulate the information with political interests.”

Yet Roman et al is not the first review of the efficacy of Ivermectin in Covid-19. Other systematic reviews and meta-analyses are available in the public domain. The conclusions of this latest review should mirror those of previous reviews when additional trials are added.

Not Acceptable in Respected Journal

With misreporting of source data, highly selective study inclusion, “cherry picking” of data within included studies, and conclusions that do not follow from the evidence, this article amounts to disinformation.

Disinformation should not be associated with any learned journal of repute. Publication of this article as it stands does a grave disservice to Clinical Infectious Diseases and the good name of Oxford University Press.

Signatories

Signatories to this letter include:

  • Edmund J Fordham MA PhD(Cantab) CPhys CEng FInstP EurIng, EBMC Squared, Northgate House, Upper Borough Walls, Bath BA1 1RG
  • Theresa A Lawrie MB BCh PhD, EBMC Squared, Northgate House, Upper Borough Walls, Bath BA1 1RG
  • Andrew Bryant MSc, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, NE2 4AX

Further signatories to this open letter include:

Disclaimer: these indicate the personal opinions of the signatories and there is no intention to associate their institutions with them.

  1. Dr. Darrell Hamm BTh BSc MD CCFP ASTMH, CANADA
  2. Dr William Ralph, MICGP 
  3. Dr Nyjon Karl Eccles, UK
  4. Dr Liesel Marcela Holler Sotomayor, MD, MRCA, UK 
  5. Dr Tony Hinton MB ChB, FRCS, Consultant Surgeon, UK
  6. Dr. Ira Bernstein, Family physician, lecturer, CANADA
  7. Prof. Hector Carvallo, Professor of Internal Medicine, ARGENTINA
  8. Dr. Dan Macias Flores, CHILE
  9. Dr. Francesco Anello MD, ITALY
  10. Dr Christina Peers MBBS.DRCOG.DFSRH.FFSRH, UK
  11. Dr. Stephen Malthouse, MD, CANADA
  12. Prof. Howard C. Tenenbaum DDS, Dip. Perio., PhD, FRCD(C), CANADA/ISRAEL 
  13. Prof. Andrea G Stramezzi MD DDS PhD, ITALY
  14. Prof. Eleftherios Gkioulekas, PhD, USA
  15. Dr. Barbara Powell, MD, CANADA
  16. Dr. Ernesto de Bernardis, MD, Clinical Pharmacologist, ITALY
  17. Dr. Roberta Lacerda Almeida de Miranda Dantas, Infectious Diseases Specialist, RQE, BRAZIL
  18. Dr. Robert Banner MD, CANADA
  19. Dr. Patrick Phillips, MD, CCFP, Family and ER Physician, CANADA
  20. Agnes Pinnel, MSc., Former CEO Clinical Research, HUNGARY
  21. Dr Sarah Hill, UK 
  22. Paul E. Marik MD, FCCP, FCCM, Pulmonary and Critical Care Medicine, USA
  23. Dr. Marc G. Wathelet, Ph.D., BELGIUM
  24. Dr. Scott Mitchell MBChB MRCS, UK
  25. Prof. Morimasa Yagisawa, PhD, Visiting Professor, Omura Satoshi Memorial Institute, JAPAN
  26. Geoffrey Taylor, prof. (retd), AUSTRALIA.
  27. Prof. Colleen Aldous, Professor of Medical Research, SOUTH AFRICA
  28. Dr Shashikanth Manikappa, MBBS,MD, DNB, FANZCA, FCA, PG Dip Echo, Specialis Cardiac Anaesthesia and Perioperative Medicine, AUSTRALIA
  29. Prof. Femi Babalola, MD, NIGERIA
  30. Dr Haleema Sheikh, MD, UK
  31. Prof. Thomas Borody, MD, AUSTRALIA
  32. Dr. Veronica A Mcburnie, MD, UK 
  33. Dr. John McCarthy BSc(Hons), PhD MBChB UK
  34. Dr. David E. Scheim, PhD, US Public Health Service, USA
  35. Ellen Guimarães, M.D, cardiologist, BRAZIL
  36. Flavio A. Cadegiani, MD, MSc, PhD, PI of the AndroCoV trials, BRAZIL
  37. Dr Manjul Medhi, Mbchb mrcp dtm+h, Consultant in Infectious Diseases and General Medicine, UK
  38. Dr Rosamond Jones, retired consultant paediatrician, UK
  39. Dr Jon Rogers MBChB,  UK
  40. Prof. Matjaž Zwitter, MD, PhD. SLOVENIA 

Call to Action: Follow the link to read the full letter.

Responses

    1. The author of those posts argument is, “HCQ was bad, so that means IVM must be too.” That’s a little like saying “Attempts at heavier-than-air-flights failed before so that means the Wright brothers must fail to.”

      There are literally dozens of positive reports on ivermectin, and maybe 1 or 2 showing no effect. It is simply unreasonable to suppose they are all showing positive effects by just coincidence:

      https://pubmed.ncbi.nlm.nih.gov/?term=(Ivermectin%20COVID-19)%20AND%20(Therapy%2FBroad%5Bfilter%5D)&sort=date

      Robert Clark

  1. The authors state that they have no conflicts of interest on the MedRxiv. However, Dr. Paspuleti’s affiliation is Cello Health. From their website (https://cellohealth.com/) Cello provides services such as “Brand and portfolio commercial strategy for biotech and pharma”. Their clients are “… 24 of the top 25 pharmaceutical companies …”. That support is the definition of conflict of interest. Dr. Paspuleti needs to disclose exactly who funded his time and effort on this project.