Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.
The NIH COVID-19 Treatment Guidelines Panel updated its recommendation on ivermectin for COVID-19 on January 14, 2021. In the update, the NIH removed its recommendation against the use of ivermectin in COVID-19. However, the Panel also declined to recommend ivermectin for use in COVID-19.
A Freedom of Information Act request was made to determine the process that was followed by the NIH in reaching its recommendation. In particular, in a FOIA request on January 25, the NIH was asked if a vote had been held on the update to the ivermectin recommendation:
“On January 6, 2021, the NIH COVID-19 Treatment Guidelines Panel met to consider updating their recommendation on the use of Ivermectin in COVID-19. Please answer the following question. As of today, has that Panel taken a vote on whether to change its recommendation? (Date Range for Record Search: From 01/06/2021 To 01/25/2021)”
The NIH declined to answer that question:
“Please be advised that the FOIA is not intended to answer questions, but rather it is meant for the public to request specifically identified and searchable Federal records that are already in existence, i.e. a record cannot be created in response to a FOIA request.”
An alternative FOIA request was formulated to answer the same question. That FOIA request was submitted on January 28, 2021:
“All updates to the Coronavirus Disease 2019 (COVID-19) Treatment Guidelines that were endorsed by a vote of the Panel. (Date Range for Record Search: From 01/01/2021 To 01/28/2021)”
The NIH was unable to respond to that request within 20 days not including weekends and federal holidays. As a result, that FOIA request is now the subject of a protracted legal confrontation in federal court. The case is ongoing but it is safe to say there was no vote on the ivermectin recommendation and that there was an intent to deceive. The NIH is not functioning as a trusted public health authority, to say the least.
At around the same time, a second FOIA request was made to the same federal agency. This FOIA request was to confirm that that meeting had been held on January 6, 2021 to consider updating the NIH recommendation on ivermectin:
“Meeting agenda, National Institutes of Health COVID-19 Treatment Guidelines Panel, January 6, 2021 (Date Range for Record Search: From 01/06/2021 To 01/06/2021)”
The NIH provided an email with the agenda. The names of two recipients of the email were given, Adaora Adimora and Timothy M. Uyeki; both Panel members. However the names of other recipients of the meeting-agenda email were redacted. According to the NIH, the names were redacted because their release “would cause a clearly unwarranted invasion of personal privacy.”
The explanation for withholding the identifies of the contributors to US national policy on ivermectin is not credible or reasonable. The US public should know who is setting the national policy on a COVID-19 treatment option. The public can then form their own opinion on the possible biases or influences on those individuals. What is the purpose of providing an extensive list of relevant financial relationships of Panel members if the identities of the relevant Panel members are not disclosed? Since those identities are not disclosed we, the public, are left to speculate.
About two months after the NIH meeting on ivermectin, the NIH announced the award NOT-TR-21–024; funding of ACTIV-6 to study the use of repurposed drugs in COVID-19. Duke University was the only institution in the country that met the criteria for the study, according to the NIH. Funding was thus distributed on a sole source basis. The “initial investment” in the trial was later announced to be $155 million. The principal investigator of the trial was not identified initially but, in a later announcement, was identified to be Susanna Naggie, who is also a member of the NIH COVID-19 Treatment Guidelines Panel.
The two positions Naggie holds clearly represent a conflict of interest. A positive recommendation on the use of the drug in COVID-19 would effectively end the clinical trial. The NIH award also raises the question of whether the prospect of the award played a role in the current recommendation on ivermectin.
The question was addressed to Naggie by email if she was the author of the NIH COVID-19 Treatment Guidelines recommendation on ivermectin. She has not responded to that question.
The review process of the NIH COVID-19 Treatment Guidelines is beyond suspicious. The NIH needs to provide the unredacted agenda to the January 6 meeting on ivermectin so that the identities of those responsible for the ivermectin recommendation are disclosed. Most importantly, we need to know if there was improper influence on the ivermectin recommendation.