On April 19, 2021, the NIH announced the ACTIV-6 trial of repurposed drugs. The NIH director, Francis S. Collins stated its purpose:
“ACTIV-6 will evaluate whether certain drugs showing promise in small trials can pass the rigor of a larger trial.”
On May 13, 2021, the trial protocol was released on ClinicalTrials.gov. The protocol specified that Ivermectin would be the subject of the study.
The study is controversial because studies have shown the effectiveness of Ivermectin in COVID-19. One meta-analysis concluded:
“… the panel agreed that ivermectin should be immediately rolled out …”
The ACTIV-6 Ivermectin trial is a placebo-controlled. Thus, the ACTIV-6 Ivermectin trial investigators will be asking volunteers to forgo treatment for COVID-19 while there is evidence for effectiveness of that treatment. Justification for conducting this trial is thus justification for withholding treatment for COVID-19.
WCG IRB reviewed and approved this protocol (although they initially claimed that they could not locate this trial in their records). However, WCG IRB has been unresponsive to a request to release the rationale for the trial. The leader of the trial Susanna Naggie provided an informal justification for the trial but declined to provide the formal rationale for the study. Ultimately, the IRB provides oversight on the ethics of the clinical trial and should be accountable to the public. Thus the request for the trial rationale is directed to the WCG IRB.
The release of the rationale is important because it will answer the following questions:
- The trial lead was aware of the study showing the effectiveness of Ivermectin in COVID-19 as reported earlier. It is more important, however, that members of the IRB were aware of that study. Did the rationale for the ACTIV-6 Ivermectin trial disclose that meta-analysis?
- A novel standard for the adoption of medical treatments was proposed by the NIH in the COVID-19 Treatment Guidelines: “Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of [ THERAPY] in the treatment of COVID-19.” This standard does not recognize the value of epidemiological or observational evidence. Was the justification of the need for this study based on this novel medical standard?
- The study lead gave the NIH assessment in an informal justification for the trial. The assessment, given in the COVID-19 Treatment Guidelines, was as follows: “There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19.” Earlier reporting suggests that the NIH did not hold a vote to endorse that statement and as such it should not be given much weight. Did the WCG IRB rely on the NIH assessment in reaching its approval for the further study of ivermectin?
To answer those questions and others, WCG IRB must release the rationale for the ACTIV-6 Ivermectin trial. If more than one version of the rationale for the trial was approved by WCG IRB it should provide all versions of the rationale.
As an ethic board, WCG IRB cannot operate in secrecy. It must provide the rationale for the ACTIV-6 Ivermectin trial.
Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite, Inc.