On January 14, 2021, the NIH COVID-19 Treatment Guidelines were updated to reflect the latest studies on ivermectin. The updated recommendation was:
“The COVID-19 Treatment Guidelines Panel (the Panel) has determined that currently there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19.”
That statement was a deception. A vote of the Panel to endorse that recommendation was never held.
The COVID-19 Treatment Guidelines were announced on April 21, 2020 to assist healthcare providers in treatment decisions in COVID-19. A group of 43 medical authorities and representatives of the community were assembled to produce the Guidelines. The NIH COVID-19 Treatment Guidelines are not legally binding to physicians or patients. As the Guidelines state:
“Finally, it is important to stress that the rated treatment recommendations in these Guidelines should not be considered mandates. The choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider.”
However, the Guidelines are generally considered authoritative on COVID-19 therapy. The New York Times “Coronavirsus Drug and Treatment Tracker” links to the Guidelines as does the Harvard Medical School “Treatments for COVID-19” website. After the release of the ivermectin recommendation, Jeffrey Klauser reported that recommendation in the Washington Post in a discussion of the use of existing drugs in COVID-19. Reuters quoted extensively from the Guidelines recommendation on ivermectin in their fact check on COVID-19. Although, there has been dissent from the Guidelines, the impact of the guidelines on clinical practice is likely very significant.
The effects of this recommendation have also been seen abroad. In South Africa, a debate has been raging over legalization of ivermectin for use in COVID-19. Until recently, ivermectin has been allowed only for veterinary use. That restriction has been loosened to allow for use in COVID-19 but only in exceptional circumstances. The NIH recommendation has been a part of that debate. That is apparent in an article by AFP Fact Check Africa clarifying the meaning of the NIH recommendation.
The Guidelines are structured to provide a recommendation for each COVID-19 therapy out of four possible options. The four options are:
- “The Panel recommends using …”
- “There are insufficient data for the Panel to recommend either for or against…”
- “The Panel recommends against … except in a clinical trial.”
- “The Panel recommends against …”
The Guidelines also provide a rating for each recommendation indicating the strength or confidence of the recommendation. The exception is the second recommendation which is the one given to ivermectin. The first sign that the updated ivermectin recommendation did not receive a vote by the Panel was from the Treatment Guidelines themselves. The Guidelines state:
“Updates to existing sections that do not affect the rated recommendations are approved by Panel co-chairs without a Panel vote.”
Since the ivermectin recommendation did not have a rating, the Guidelines could conceivably be updated without holding a vote of the Panel.
The second sign was the response from the NIH to a Freedom of Information Act request. The FOIA request was for the NIH to answer whether a vote had been held to update the Guidelines on ivermectin. The NIH declined to answer that question in their response. Federal government agencies are not required to answer questions in response to FOIA requests.
A third sign was the response to an email sent to a Panel member, Adaora Adimora, with the same question. The response to that email came from an NIH administrator who also declined to answer the question. In this case, there was no reason given for why the question was not answered.
In addition to the question of whether a vote was held on the ivermectin recommendation, there are questions about the process that was followed for producing that recommendation. The general process for producing the Treatment Guidelines recommendations is described in the Treatment Guidelines:
“Each section of the Guidelines is developed by a working group of Panel members with expertise in the area addressed in the section. Each working group is responsible for identifying relevant information and published scientific literature and for conducting a systematic, comprehensive review of that information and literature. The working groups propose updates to the Guidelines based on the latest published research findings and evolving clinical information.”
In the case of ivermectin, the working group “Team 2” was assigned to develop the recommendation. We know that they met on January 6, 2021 to consider an update to that recommendation. We also know, based on a FOIA request, that two of the group members were Adaora Adimora and Timothy M. Uyeki. The NIH provided the agenda to the January 6 meeting which included the names of those two Panel members. However, we do not know the names of the remaining members of this working group. The NIH redacted the names of the remaining members of the working group citing the need to protect members from invasion of privacy. It is not clear how disclosing the name of a Panel member who attended an NIH meeting could be an invasion of privacy. It is also not clear how it would be an invasion of privacy for some Panel members but not for others.
I have provided the co-chairs of the COVID-19 Treatment Guidelines Panel, Roy M. Gulick, H. Clifford Lane and Henry Masur with a draft of this story and asked for their comments or corrections. They have not responded.
Why won’t the NIH confirm that a vote had been held to endorse the ivermectin recommendation? The answer is obvious. There was no vote. We don’t even know who wrote the recommendation. The ivermectin recommendation was a deception.
Deception by the authorities is disturbing under any circumstances. This deception is horrifying.