Following the release of the TOGETHER Trial results to the press in August 2021, media headlines quoted that ivermectin had ’no effect whatsoever’ when used for Covid-19. This press release from TOGETHER Trial investigators influenced international health policy to withhold ivermectin for the prevention and treatment of Covid-19 despite compelling evidence from numerous independent experts, scientific papers, and real world data that mass administration of ivermectin would be effective and safe for Covid-19.
The final report of the TOGETHER Trial, published in March 2022 in the New England Journal of Medicine, has major discrepancies in the data compared with what was published by the media more than six months earlier in addition to serious methodological inconsistencies that must be brought to light. Despite numerous requests by international scientists to address these issues, none has been forthcoming by TOGETHER Trial authors.
Probable Scientific Misconduct Uncovered
A breaking development has highlighted the probability of scientific misconduct associated with this trial, when the manager of the International COVID-19 Data Alliance (ICODA) confirmed that its website, to which the TOGETHER trial has been directing inquiries for deidentified patient data since the study’s publication on March 30, never actually hosted the study’s data.
Dr. David Scheim, Dr. Edmund Fordham, and Professor Colleen Aldous have sent a letter (part of which is included below) to the TOGETHER Trial authors, the NEJM Editor-in-Chief, and others asking for the data to be made available immediately or to retract the paper.
Call for Action
This is not the first time that attempts have been made to manipulate data and scientific manuscripts to undermine the evidence that shows ivermectin is effective against Covid-19. The World Council for Health urges journalists, scientists, and civil society to focus due attention on TOGETHER Trial investigators so that they reveal what has been hidden.
The World Council for Health supports the use of ivermectin for the prevention and treatment of acute Covid-19, Long Covid, and for Covid-19 vaccine injury under the supervision of trusted health practitioners.
Letter to TOGETHER Trial authors, the NEJM Editor-in-Chief, and others:
BREAKING: The TOGETHER trial data was never at its cited ICODA repository or otherwise available
Dear coauthors of Reis et al., 2022,1 the Editor-in-Chief of the New England Journal of Medicine; and (cc’d) editors of other scientific journals, science reporters, bioethicists and other distinguished scientists:
In a breaking development yesterday, we learned that the TOGETHER trial has misdirected inquiries to a web repository that never hosted its data, thereby denying the scientific community access to the underlying data for its ivermectin arm since that study’s publication on March 30.
A manager of the ICODA data repository emailed us yesterday that its website, to which the TOGETHER trial has been directing inquiries for deidentified patient data since the study’s publication on March 30, never hosted the study’s data.
This took two months to ascertain, in part because ICODA’s listed telephone number still gives the recorded message, “you have reached a number that is not currently set up to receive calls.”
Given this flagrant breach of scientific ethics in thwarting access to data with a spurious link, the four outcome measures that scientists have repeatedly requested since April 11, comparative per protocol death and hospitalization rates, treatment vs. placebo, should be disclosed immediately. Note that these are the key outcomes of interest, since both the NIH and FDA found the study’s nonstandard primary outcome measure to be inadequate.
It is especially troubling that study co-author Dr. David Boulware evaded our May 10 request for the study’s four key outcome numbers (email thread below) by misdirecting, once again, to this spurious link to ICODA, which never hosted the TOGETHER trial’s data.
The degree of data irregularities and concealment of data here is of a scale unmatched since the Surgisphere scandal of June 2020, which resulted in retractions in the New England Journal of Medicine (NEJM, the publisher of this March 30 study) and in the Lancet.
As noted, the study coauthor cited above who replied twice in response to our May 10 letter could not furnish even the simplest accurate information about the study data, its repository location. It is therefore imperative that a study coauthor who can accurately report on this data immediately disclose to the scientific community the four numbers for comparative per protocol death and hospitalization rates as repeatedly requested since April 11. Expedited access to “complete deidentified patient data,” as the study promised beginning “immediately after publication,” on March 30, must also be provided. If these are not provided promptly, we request that the NEJM retract this study.
David E. Scheim, PhD, US Public Health Service, Commissioned Corps, Inactive Reserve, Blacksburg, Virginia, USA
Colleen Aldous, PhD, MASSAf (fellow, Academy of Science, South Africa), School of Clinical Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa
Edmund J. Fordham, PhD (Cantab) FInstP, EbMCsquared CiC, Bath, England
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