JAMA to “alert the authors” of ethics concern about ivermectin study

JAMA to “alert the authors” of ethics concern about ivermectin study

On March 4, 2021 the Journal of the American Medical Association (JAMA) published results from a clinical trial on ivermectin in COVID-19. The study found no benefit of the drug in patients with mild disease for time to symptom resolution. The authors suggested that results from their study may indicate ineffectiveness of ivermectin beyond time to symptom resolution:

“…although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes.”

One controversial aspect to this study has been the title of the study protocol. The final title was “Double blind, randomized, controlled clinical trial to investigate the effectiveness of the D11AX22 molecule in adult subjects from Valle del Cauca with initial stages of infection by SARS CoV2 / COVID19.” Since the term “D11AX22 molecule” was used in the title of the study protocol it is possible that that term was also used in the consent form.

The use of ivermectin in COVID-19 in Cali, Colombia, the location of the study, was increasing at the time of the study. On July 10, 2020, the mayor of Cali, Jorge Iván Ospina, announced the distribution of 10,000 doses of ivermectin in spite of the warning from the Colombian National Institute of Food and Drug Administration (Invima) that its effectiveness and safety in COVID-19 had not been proven. Due to the coverage of the city’s distribution, it is possible that the term “ivermectin” would have been meaningful to the study subjects. The term “D11AX22 molecule”, on the other hand, is not commonly used for this drug. In the study protocol, each time “D11AX22” is used in the text, the term “ivermectin” is added in parentheses.

The question about the possible use of “DX11AX22” in place of “ivermectin” in the consent form was first posed in a review of the article. The question was also asked directly to the authors of the publication, study support staff and to administrators of Centro de Estudios en Infectología Pediátrica (CEIP) which organized the trial. None have responded. The question was also posted as a comment to the JAMA article.

JAMA editor-in-chief, Harold Bauchner, was asked about the JAMA response. His response was “We will alert the authors to the query.” This needs to be dealt with in a public manner though.

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

Responses

  1. I don’t see it as an "ethical" concern. I’m not a scientist. I’m a high school math teacher. I still believe ivermectin is highly effective against covid and that the most important "ethical" question about this article is why a study where the placebo group does so much better than expected is published in the first place.

    1. Informed consent is fairly central for the ethics of clinical research. It is impossible to claim that a study subject has given informed consent if he/she has been deliberately deceived about the treatment. I doubt there is another example of this type of clinical-trial recruitment in the modern medical literature.

  2. There’s some shifty sh*t going on here, I can’t help but wonder about drug company involvement into the outcome of these studies, remember billions of dollars are at stake here.

  3. For me the biggest hole is the alleged accidental use of ivermectin for the control group. It was only picked up months later… how can anyone be sure retrospectively which subjects received a genuine placebo? This alone is enough to disqualify the study from publication. The fact it still passed peer review is indicative of corruption.
    Also of concern is the disqualification of participants post-admission due to alleged breaches of selection criteria. This may be indicative of changes to those criteria post study, which would again invalidate the entire study.
    Is there not any form of legal redress against clearly fraudulent peer review?

  4. There are holes in this JAMA published study big enough to drive a truck through! Why JAMA chose this study of all the Ivermectin studies to publish is very eyebrow raising.