A study appeared in JAMA on March 4 showing that:
“Among adults with mild COVID-19, a 5-day course of ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms.”
Ivermectin has been under consideration by the National Institutes of Health (NIH) for treatment of COVID-19. The current NIH recommendation is neither for nor against the use of ivermectin in COVID-19. That recommendation is based on the NIH assessment that there are “insufficient data” to make a recommendation.
In this context, the JAMA article has thus had an immediate impact. As of this writing, the publication has been viewed over 400,000 times. The New York Times broke the news on the same day of the JAMA publication. The headline read:
“Popular Drug Does Not Alleviate Mild Covid-19 Symptoms, Study Finds”
CNN broke the news the following day. The article titled:
“FDA warns against using anti-parasitic drug for COVID-19 after reports of hospitalizations”
CNN did not refer to the JAMA article in its headline but it was one of the topics of the article.
A question has arisen about the study though: “Was it ethical?”
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.
Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.