Just on Wednesday, the National Institutes of Health (NIH) invited the Front Line COVID-19 Critical Care Alliance (FLCCC) to present to this apex national research agency’s COVID-19 Treatment Guidelines Panel. The most influential of any such group worldwide, the NIH’s Treatment Guidelines Panel now is taking the time to review the unfolding ivermectin situation. A key question: does the accumulation of data to date in connection with ivermectin COVID-19 randomized controlled trials indicate sufficient evidence for institute action? TrialSite commends the NIH for now reviewing this important and unfolding situation. Of course, such a meeting wouldn’t be possible if it were not for the dedicated, committed and relentless efforts of the physician/researchers’ embrace of an unfolding story TrialSite had been chronicling since April. The FLCCC, led by Dr. Pierre Kory and Dr. Paul Marik, along with prominent British researcher, Dr. Andrew Hill, affiliated with the University of Liverpool in the UK, presented their respective meta-analysis findings to date. The NIH’s powerful Panel indicated their Guidelines should be updated by February.
TrialSite works closely with the FLCCC and was able to catch up with Dr. Pierre Kory. What follows is a brief introduction to this Panel, the Guidelines and a breakdown of this situation for the TrialSite Network.
Again, the physician/researchers representing the FLCCC were joined with Dr. Andrew Hill, the senior research associate affiliated with the University of Liverpool to share the status of their research thus far, as well as an opportunity to articulate their professional and scientific opinions on the unfolding data associated with randomized controlled trials around the world.
The NIH invited the FLCCC members along with Dr. Hill to the panel to present the four months of data on Ivermectin that has emerged since the NIH last issued guidelines on August 27. During this meeting, the FLCCC and Dr. Hill initiated discussion with the panel concerning the numerous clinical trial data accumulated to date—that data that is captured in the team’s unfolding meta-analyses—representing what is now 18 randomized, controlled trials that covers over 2,100 patients. The research points to benefits of ivermectin in prophylaxis, early treatment and even late stage advantages. The physician/researchers suggest to this powerfully influential panel that in the aggregate, there is sufficient data to “substantiate enough to reliably assess clinical efficacy.”
What are the COVID-19 Treatment Guidelines Panel members?
The Treatment Guidelines Panel Member leadership includes Roy M. Gulick, MD, from Weill Cornell Medicine, MD MPH, Clifford H. Lane, MD and Henry Masur, MD with the NIH, as well as dozens of prominent physicians and principal investigators/researchers from the nation’s most prominent academic medical centers. Full membership can be viewed here.
What is the importance of the NIH’s COVID-19 Treatment Guidelines Panel?
Frankly, this group wields the power to influence how patients are treated worldwide. Each and every update to the Guidelines are watched by all relevant research authorities. Thus, this is the most influential group in the world when it comes to evaluating and either approving or rejecting a particular approach when dealing with COVID-19. That’s how significant this meeting was on Wednesday.
A critically important initiative, the NIH established the COVID-19 Treatment Guidelines to inform clinicians how to care for COVID-19 patients. They had to take this approach due to the fact that SARS-CoV-2 was a new disease—no researcher or physician knew how to treat the virus.
They are operating in a very dynamic situation. An unfolding story with new data and potential evidence emerging, pandemic conditions introduce a difficult decision making challenge. On the one hand, speed is of the essence as in the USA over 370,000 people have died due to this horrific virus—that figure approaches 2 million worldwide. On the other hand, desperate situations cannot force compromised decision making. The Panel must make informed decisions based on solid scientific evidence—and this can and does take time.
On the group’s website, they note that they seek to update the Guidelines frequently as their working members review published data and other authoritative information, such as the visit that just occurred.
How does the Panel make recommendations?
The NIH’s Guidelines are based on scientific evidence and expert opinion. In each recommendation, the Panel includes two ratings including a letter (A, B, or C) and a corresponding Roman numeral (I, II or III). The letter rating indicates the strength of the recommendation and the Roman numeral points to the quality of the evidence that supports the recommendation. This information is taken from the NIH’s website and can be reviewed here.
The NIH’s COVID-19 Treatment Guidelines Panel has organized working groups of Panel members that are continuously reviewing unfolding data in what is a dynamic and complex situation associated with the pandemic.
These working groups are responsible for the development of any new Guideline sections as well as recommendations and any updates to the existing Guidelines sections. A majority of the Panel members must endorse a recommendation before any change to the Guidelines.
TrialSite also includes the NIH Panel’s Recommendation Rating Scheme below.
|Strength of Recommendation||Quality of Evidence for Recommendation|
|A. Strong recommendation for the statement||I. One or more randomized trials with clinical outcomes and/or validated laboratory endpoints|
|B. Moderate recommendation for the statement||II. One or more well-designed nonrandomized or observational cohort studies|
|C. Optional recommendation for the statement||III. Expert opinion|
How does the panel review Ivermectin today?
Last updated in August, the NIH’s COVID-19 Treatment Guidelines currently recommend against the use of ivermectin for the treatment of COVID-19, except in a clinical trial. They give it a ranking of “AIII.” So on the one hand, Ivermectin has the highest rating based on the Panel’s “strength of Recommendation” yet the lowest score based on the “Quality of Evidence for Recommendation.”
Interestingly, to date, the Panel hasn’t included any of the clinical trials covered in the meta-analyses authored by both the FLCCC and the UK’s Dr. Hill. However, the fact that the Panel invited the experts to come and present their findings is a huge step.
What has the FLCCC found thus far?
Based on the data analyzed from 18 randomized controlled trials and 2,100 patients. the team articulated that the results demonstrated that ivermectin produces faster viral clearance, faster time to hospital discharge, faster time to clinical recovery, and a 75% reduction in mortality rates.
Following the hearing Dr. Pierre Kory, FLCCC’s president stated, “In order to be safe thousands who will die while waiting for their turn to receive the vaccine, it is imperative that treatment guidelines issued by the NIH over four months ago be updated to reflect the strength of the data for ivermectin in prophylaxis, early treatment, and late-stage disease.”
What are the results of this meeting?
The NIH panel signaled to the FLCCC their intention to consider the data and they anticipate an update to the current recommendations by early February.
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