NOTE: this would explain why both placebo and treatment arms did multiple times better than expected by researchers - in all likelihood both arm participants were taking ivermectin.

Since ivermectin use is endemic in Colombia, and the mayor was distributing pills to the public at that time, if the public had been informed that they were participating in an ivermectin trial they may have refused - why take the risk of not getting the drug when they could get ivermectin with 100 percent surety on the street.

Thus it seems likely the researchers employed subterfuge to mask this information from the participants in order to ensure willingness to participate.

This also significantly raises the possibility that participants in both arms were taking ivermectin on their own without telling the researchers. Because ivermectin use is endemic in Colombia, and the mayor was distributing pills to the public at that time

See sections below where Dr Tess Lawrie warns about this exact problem once public knows a drug works. That makes it difficult to recruit willing participants.

Also see section below on the AZT trial during the 1989 AIDS pandemic, where study participants did drug sharing to ensure everybody got some of the drug.

 

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https://trialsitenews.com/jama-unable-to-confirm-ivermectin-study-consent-form-used-ivermectin/ JAMA unable to confirm ivermectin study consent form used “ivermectin” By Peter J. Yim, PhD  March 15, 2021

The study, of course, involved human subjects and as such the study must follow strict guidelines to ensure that the rights of the study participants are respected. One of those rights is that informed consent must be obtained from each study participant. In this study, there are growing concerns that the study subjects did not provided meaningful informed consent. As reported earlier, the title of the study protocol referred to ivermectin as “D11AX22 Molecule”. This term probably would not have been familiar to the study participants whereas “ivermectin” may have been. The study was conducted in Cali, Colombia. At the time of the study, the mayor of the city, Jorge Iván Ospina, announced a large-scale distribution of this medication.

The first two authors of the study were Eduardo López-Medina and Pío López. We contacted them by email to ask if the term “D11AX22 Molecule” was used in the consent form. Elizabeth Toro is listed as a contact for the study on its registration at clinicaltrials.gov. She was asked the same question as was the general administrative contact at Centro de Estudios en Infectología Pediátrica, the host organization of the study. There has been no response to this question. We asked the editor-in-chief of JAMA, Howard Bauchner, to comment on a draft of an article on this subject. He who offered to “alert the authors to the query.” Three days later it appears that Bauchner may have lost interest in this issue. We asked Bauchner: “Did the consent form for the study published in JAMA use the word “ivermectin”? Bauchner responded :“JAMA does not review consent forms.” We then asked : “You said you would ‘… alert the authors to the query [about the informed consent]’. Did they respond?” One day later Bauchner has not yet responded to that question. The question of whether a clinical study consent form uses the word “ivermectin” is trivially simple to answer. JAMA needs to clear this up immediately.

 

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AZT trial and participant behavior to ensure they get the drug

The participant behavior to maximize survival, to ensure they get the active drug and not placebo, is not unknown in trials. This example from the AZT trials during AIDS epidemic from the late 1980s:

https://www.spin.com/featured/aids-and-the-azt-scandal-spin-1989-feature-sins-of-omission/ AIDS and the AZT Scandal: SPIN’s 1989 Feature, ‘Sins of Omission’

The story of AZT, one of the most toxic, expensive, and controversial drugs in the history of medicine

Written by Celia Farber

Many of the patients who were in the trial admitted that they had analyzed their capsules to find out whether they were getting the drug. If they weren’t, some bought the drug on the underground market. Also, the pills were supposed to be indistinguishable by taste, but they were not. Although this was corrected early on, the damage was already done. There were also reports that patients were pooling pills out of solidarity to each other. The study was so severely flawed that its conclusions must be considered, by the most basic scientific standards, unproven.

 

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Dr Tess Lawrie on difficulty in recruiting participants to placebo if public thinks Ivermectin works

Dr Tess Lawrie has mentioned this exact problem with more RCTs going forward - researchers may not be able to recruit willing participants if they know ivermectin is being used, and they will be denied it if they happen to fall in the placebo arm after randomization. Once patient knows a drug has benefit, they will seek to maximize their survival.

https://www.reddit.com/r/ivermectin/comments/lza64t/dr_john_campbell_interviews_dr_tess_lawrie/ Dr John Campbell interviews Dr Tess Lawrie (meta-analysis and BIRD panel) - interesting because Campbell has a large viewership, and appears on Deutsche Welle TV as well (March 7, 2021)

https://www.reddit.com/r/ivermectin/comments/lza64t/dr_john_campbell_interviews_dr_tess_lawrie/gq0e33u/

at the 26:34 minute mark:

(few minutes after that)

Dr Tess Lawrie: None of the studies have looked at long covid19, but there are some studies and data coming out of Argentina, possibly Peru as well, where they have been giving ivermectin to long covid19 patients with really promising results. So I think if there is any research to be done - esp. since long covid19 has no treatment options, and so many people are suffering from long covid19 now. It would be very intersting to see a trial that is randomizing people to ivermectin for long covid19 or not. And it needn't be - the reason I say I wouldn't mind a trial in this, but I would mind a placebo-controlled trial on ivermectin for treatment, because we know it works for treatment - and I don't think that is ethical. But for long covid19 it could be ethical - because we could do it for 2 weeks and the patient would still have the option of then going on to ivermetin thereafer.

Dr. John Campbell: that is a very important point there, because if you know a treatment is efficacious, and you are deliberately withholding treatment from a group of patients by putting them in the control arm by giving them a placebo, that is .. we can only recruit people into trials if we genuinely don't know.

Dr Tess Lawrie: Yes I think this is a very important point, because there are new trials starting up, and I think any new trials starting up should have on the consent form that the existing evidence shows that ivermectin may reduce your risk of death substantially. And I think there would be very few people willing to take part in such a trial.

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