The censorship surrounding the use of existing drugs to treat COVID-19 early, before an individual may need to go to the hospital, is a contentious topic acknowledged by many experts around the country. One such potential treatment is the drug Ivermectin. On January 14, 2021, citing insufficient data, the National Institutes of Health (NIH) updated its COVID-19 Treatment Guidelines recommendation for the use of Ivermectin in managing COVID-19. In doing so, the NIH removed its previous statement against recommending the drug and instead issued a non-recommendation, asserting:
“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.”
Curious how the NIH reached its recommendation to neither be for or against the use of Ivermectin in treating COVID-19, award-winning biomedical engineer and computer scientist Peter J. Yim, Ph.D., filed a complaint against the agency on March 26, 2021. Yim, a certified public high school physics teacher, held a fellowship in the Clinical Center at the NIH and was on the faculty of the Dept. of Radiology at the Robert Wood Johnson Medical School. He is the founder of Virtual Scalpel, Inc., a technology startup. UncoverDC recently spoke with Yim, who offered this quote to put into context his concern:
”A foundation for the anti-Ivermectin position has been the recommendation by the NIH that ’There is insufficient evidence 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.’ My complaint against the NIH seeks to show that the NIH position is a deception; the ’Panel’ never considered the question.”
Significance of the COVID-19 Treatment Guidelines
The COVID-19 Treatment Guidelines were introduced on April 21, 2020, to assist healthcare providers in treatment decisions in COVID-19. The NIH assembled a group of 43 medical authorities and representatives of the community to develop the Guidelines. The NIH COVID-19 Treatment Guidelines are not legally binding to physicians or patients. Still, Yim maintains the Guidelines are “regularly considered authoritative on COVID-19 therapy.” Furthermore, despite noted dissent from the Guidelines, the influence they have on clinical practice is reasonably quite significant. Illustrating further, he adds:
“The New York Times “Coronavirus 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.”
Yim explains how the NIH Guidelines are structured to provide a recommendation for each COVID-19 therapy out of four potential options, which 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 three of the four recommendation options indicating the strength or confidence of the treatment. The option that is not rated is the second one, which is the one given to Ivermectin. The Guidelines state:
“Updates to existing sections that do not affect the rated recommendations are approved by Panel co-chairs without a Panel vote.”
Low usefulness underpowered ivermectin RCT in young patients published by JAMA.
IVM arm shows:
• lower mortality
• lower disease progression
• lower hospitalization or ICU or O2 need
• faster symptom resolution
but no stat significance due to design.https://t.co/59nCtWJje3
— Covid19Crusher (@Covid19Crusher) March 5, 2021
Did the Panel Consider & Vote for Ivermectin’s Non-Recommendation?
Yim’s initial suspicion that the updated Ivermectin recommendation did not receive a vote by the Panel came from the Treatment Guidelines themselves. Realizing the Ivermectin recommendation does not have a rating, it is plausible the Guidelines were updated without the NIH holding a vote of the Panel.
The response from the NIH to a Freedom of Information Act (FOIA) request from Yim was the second indication a vote was not held to update the Guidelines on Ivermectin. When asked specifically if a vote took place, the NIH declined to answer the question in their response, pointing out that federal government agencies are not required to answer questions in response to FOIA requests.
The third indication that Ivermectin’s non-recommendation was made without consideration was Panel member Adaora Adimora’s response to an email sent by Yim asking the same question. The email reply came from an NIH administrator who also declined to answer the inquiry and offered no explanation why the agency did not answer the straightforward question.
Besides the issue of whether the NIH intentionally debated Ivermectin and then held a Panel vote, the method the agency followed for delivering Ivermectin’s updated non-recommendation is unclear. The general process for forming Treatment Guidelines recommendations described in the literature states:
“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.“
<strong>NIH: N</strong>ot enough data to say whether ivermectin can help patients with coronavirus https://t.co/vSf3jSRl3u
CNN statement "But so far, no one has shown it helps actual patients." is categorically, unequivocally, atrociously false. See NIH Treatment Guidelines.
— Peter J. Yim (@PeterJYim1) January 20, 2021
Yim’s research uncovered that the working group “Team 2” was assigned to develop the recommendation for Ivermectin. The group met on January 6, 2021, to examine an update to its guidance for the drug. Based on a FOIA request, the NIH informed Yim that two members of “Team 2” were Panel members Adaora Adimora (a colleague of Ralph Baric’s at UNC) and Timothy M. Uyeki, whose names appeared on the agenda for the January 6 meeting. However, the NIH redacted the names of the remaining members of this working group, citing the need to protect members from an invasion of privacy. The agency neglected to explain why it’s an invasion of privacy to reveal the names of some Panel members but not others.
Yim’s Complaint Seeking Answers
After the NIH repeatedly ignored Yim’s FOIA request within the time defined by statute, he filed his lawsuit pro se by email. Yim’s complaint alleges that the use of Ivermectin in COVID-19 is at issue, and research on the drug therapy should not have been dismissed without careful and thorough consideration by the full COVID-19 Treatment Guidelines Panel:
“14. NIH states that there is ‘insufficient data’ to this point to recommend the use of Ivermectin in COVID-19. That view is shared by Merck, who issued a statement on February 4, 2021, about Ivermectin: ‘No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and; A concerning lack of safety data in the majority of studies.’
“15. Others disagree. The national governments of Slovakia, Czech Republic, Macedonia, Belize, Bolivia and Peru, the government of the province of Uttar Pradesh in India, and the government of Mexico City in Mexico, have all authorized the use of Ivermectin in COVID-19. The government of the state of Chiapas in Mexico conducted a mass distribution campaign of Ivermectin.
“16. Because of this controversy over the use of Ivermectin in COVID-19, Yim seeks to better understand how NIH reached the Guidelines recommendation on Ivermectin.”
On June 30, the NIH responded to Yim’s complaint, offering an exhibit and testimony concerning Yim’s request for information. NIH attorney Margaret Ann Mahoney declared the agency had responded to the FOIA request. Nonetheless, the purpose of Yim’s request was to find out if a consideration and Panel vote was held to endorse the NIH recommendation on Ivermectin. Mahoney’s response stated:
“You requested 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). All approved updates to the guidelines are posted online and can be found here. The documents posted on this website respond to your request in full.”
With the NIH still not providing a clear answer to Yim’s question, a hearing was held on August 25, 2021. The NIH appeared in a conference in Federal Court in the District of New Jersey for resolution of ‘Jin-Pyong Peter Yim v. National Institutes of Health,’ and for the scheduling of “motion practice” if necessary. Presided over by Judge Lois H. Goodman, her concluding remarks can be heard here.
The NIH Runaround & Panel Conflicts of Interest
Following the conference, Yim indicated he would accept the FOIA response given by the NIH, alluding that Ivermectin’s recommendation was endorsed by a vote of the Panel, but only if it included in a document signed by an NIH employee confirming that fact. The NIH did not accept that offer. Instead, they offered an alternative language for the FOIA response that was just as vague.
This is just the beginning for the ACTIV-6 platform trial- more repurposed drugs to be added very soon. https://t.co/safIPSq5fr
— Susanna Naggie (@snaggie1) June 16, 2021
On September 11, Yim elaborated on additional information regarding conflicts of interest with at least four members of the “Team 2” working group, which he learned had a total of nine members. Three members—Adaora Adimora, Roger Bedimo, and David V. Glidden—disclosed a financial relationship with Merck, which has campaigned against the use of Ivermectin in COVID-19. A fourth member, Susanna Naggie, had a likely “extraordinary” conflict of interest. Following the NIH’s non-recommendation, Naggie received a $155 million grant from the NIH for the study of Ivermectin. Without making any assumptions on whether Naggie was planning to apply for the grant at the time of the considerations on Ivermectin, Yim points out that “funding for the study would have been difficult to justify if the drug was recommended for use in COVID-19.”
In summary, Yim emphasizes the NIH has gone to excessive effort to avoid affirming whether the Panel held a vote to endorse the Ivermectin non-recommendation, including challenging a FOIA request in federal court. Yim declares, “a deceptive non-vote would constitute an atrocity,” adding:
“The deception and secrecy surrounding the NIH Ivermectin non-recommendation should have raised serious doubts about its integrity. The grotesque conflicts of interest of panel members should make it clear that the NIH, as the FDA with its slandering of Ivermectin as a “horse dewormer,” should not be taken seriously.”