TrialSite has also covered the original poster's David Scheim rebuttal of the Brazil JAMA paper:

 

https://trialsitenews.com/did-the-lopez-medina-study-in-cali-colombia-ivermectin-trial-include-protocol-deviations-and-38-switched-ivermectin-and-placebo-doses/

Did the López-Medina Study in Cali Colombia Ivermectin Trial Include Protocol Deviations and 38 Switched Ivermectin and Placebo Doses? By TrialSite Staff  March 11, 2021

Many TrialSite Network members have sent in numerous questions, issues and concerns about the recent Cali Colombia ivermectin study led by Eduardo López-Medina, MD, MSc, and published by JAMA. Why did the mainstream media (e.g. CNN and New York Times) also pounce so fast on the story when so many positive trials have gone by without any interest? Critics of the positive result studies involving ivermectin have tossed indiscriminate criticism involving study design and study quality. Not surprisingly, none of the issues or concerns, including potential conflict of interest with direct pharmaceutical industry payments during the study raise even a word. And what about protocol violations in the study, including 38 switched ivermectin and placebo doses, failure of blinding and other considerations, such as the fact that there are widespread over the counter (OTC) ivermectin sales in the same city where the trial site is located. With nearly identical adverse events in both the ivermectin and control groups, just a number of questions mount. Why aren’t the experts out there critiquing this study? Is the Ivermectin finding in this case serving some underlying pecuniary interest?

The study, known as “López-Medina et al., Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial” published in JAMA, 2021 was recently taken by authors David Scheim, Jennifer A. Hibberd and Juan Chamie-Quintero. 

Follow the link to learn more. If the authors are correct, with actual protocol violations, 38 switched protocol violations and, more how could the JAMA reviewers not have caught this? Where is the news media shouting about design quality? Read the entire piece and determine yourself what is the situation.

permalink

Abstract

A randomized controlled trial for treatment of mild cases of COVID-19 conducted in Cali, Colombia reported no statistically significant differences in outcomes for its ivermectin (IVM) and placebo arms. A striking anomaly, however, was that certain adverse events (AEs) that are distinctive for the study’s high-dose IVM use occurred at nearly identical rates in its IVM and placebo arms. The backdrop for these indicators of IVM use in study controls was widespread sales of IVM for COVID-19 in the Cali area during the study period, with 1.6 IVM doses sold over the counter for each case of COVID-19. The study compounded these risks of contamination of the control arm with critical errors in blinding and segregation of IVM v. placebo doses. A labeling error substituted IVM for placebo doses of 38 patients. Also, 5% dextrose solution was used for several weeks as a placebo, easily distinguishable from bitter tasting IVM. Given widespread availability and sales of IVM in Cali, lapses in segregation and blinding of IVM and control doses, and IVM-characteristic AEs in controls, the integrity of the study’s control arm was violated. Some useful information can nevertheless be salvaged from outcomes of this study’s IVM treatment arm, which had 0 deaths and generally mild symptoms, with AEs typical for high-dose IVM (replicated in the control group) that were generally mild and transient.

Preprint DOI

10.31219/osf.io/u7ewz

permalink