Table of Contents
Research Publication Retractions During the COVID-19 Pandemic
Early Treatment Medicine Retractions
On May 22, 2020, a paper was published in the Lancet by researchers from Surgisphere Corporation. Titled 'Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis', it retrospectively analyzed data of hospitalized COVID-19 patients from a registry that included 671 hospitals across 6 continents. Because of this significant coverage, 96,032 patients met the study's inclusion criteria - hospitalized with COVID-19 between Dec 2019 and April 2020, and treated with a chloroquine or hydroxychloroquine (HCQ) regimen (14, 188) or in the control no treatment group (81,144). The study found that all treatment regimens examined (HCQ alone or with macrolide, chloroquine alone or with macrolide) was independently associated with increased death in hospital. The study noted that the use of early-treatment regimens including HCQ or chloroquine since March 2020 had thus far been based on small, low-powered studies. The Surgisphere study was the first large multi-national registry-based study to show a significant negative effect of early-treatment regimens using HCQ.
The response to the study was swift. In a day or two, major public health authorities, including the World Health Organization ordered clinical trials of HCQ to cease. This included the Solidarity Trial (https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-hydroxychloroquine). Several nations ordered its use to stop.
But many had questions. Who was Surgisphere? How did their researchers acquire access to such a large-multinational registry? Who were the participating hospitals? Where was the raw data, and why didn't the data align with national records of COVID-cases for those dates? On May 28, 2020, an open letter was sent to the lead authors and Lancet editor with 201 signatories from 6 continents (https://zenodo.org/record/3871094). The letter raised serious concerns about the authenticity of the study and its findings, and questioning its peer review process.
On June 5, 2020, the paper was retracted by Lancet and the authors, as was another published in the New England Journal of Medicine that found that the use of ACE-2 inhibitors did not increase risk of COVID hospital-deaths. The WHO reinstated the Solidarity HCQ trial following the retraction, and then officially halted it on June 19, 2020.
After the Lancet paper was retracted, on June 18, 2020 another paper was published in the New England Journal of Medicine by three of the same authors of the Lancet study and two others (Mandeep R. Mehra, M.D., Sapan S. Desai, M.D., Ph.D., SreyRam Kuy, M.D., M.H.S., Timothy D. Henry, M.D., and Amit N. Patel, M.D.). The study, Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19, relied on the data from the Surgisphere data set. The conclusions of this study countered previous findings of a potential harmful association of ACE inhibitors or ARBs with in-hospital CoVid-19 deaths.
This second study using Surgisphere data was retracted by the authors on June 25, 2020, just one week following its publication. The retraction reads: “Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.”1 We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.”
SARS COV-2 Origin Retractions
On Jan 30, 2020, a controversial pre-print was released on BioRxiv by a team of researchers from New Delhi, India (https://www.biorxiv.org/content/10.1101/2020.01.30.927871v1). The researchers compared the genetic sequence of SARS COV-2, the virus responsible for COVID-19, to SARS-CoV, which had caused the SARS pandemic of 2003. They found 4 insertions in the SARS COV-2 viral genome that was not present in any other coronavirus. Instead, further analysis suggested that three of the translated inserts shared similarity with HIV gp120, a glycoprotein on the surface of HIV that attaches to the target cell plasma membrane, while the fourth mapped to HIV-Gag protein, which is the main structural protein of HIV-1 and all other retroviruses (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3251841/).
Over many days of its release, the article amassed much criticism from all angles and was widely panned for what critics said were shortcomings in their technical approach and interpretation of results. The preprint amassed several hundred comments. Soon thereafter, the authors withdrew the preprint, writing that they “intend to revise it in response to comments received from the research community on their technical approach and their interpretation of the results”.
Vaccine Research Retractions
In December 2020, the University of Queensland in Australia decided to withdraw further trials on Australia's much touted vaccine candidate, UQ Covid-19 vaccine, a protein subunit vaccine, due to the generation of HIV antibodies in trial participants that resulted in weak HIV-+ results (https://www.uq.edu.au/news/article/2020/12/update-uq-covid-19-vaccine).
The UQ vaccine used a registered trademark 'molecular clamp technology'. The clamp is used to keep the spike protein in its 'pre-fusion' form, which is the version of the protein to which the most effective antibodies have been known to be generated. The UQ clamp consists of a fusion subunit of HIV gp41 protein, a transmembrane HIV-1 protein (https://www.sciencedirect.com/topics/immunology-and-microbiology/gp41). To produce the clamp, they took the spike protein sequence and generated versions of the protein that would be most stable with the clamp (https://www.nature.com/articles/d42473-020-00504-2?source=globalbiodefense).
Due to the weak HIV-+ results, the trials were withdrawn.