NIH COVID-19 Panel member received massive windfall from ivermectin non-recommendation

NIH COVID-19 Panel member received massive windfall from ivermectin recommendation

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.

Responses

  1. Thanks for your continued pressure on the NIH. These institutions are so far gone, I’m afraid they all need to be blown-up and restarted from scratch. I don’t think we have legal mechanisms to do that, though.

  2. Laudable investigative journalism, BUT poorly titled and written, with the IDENTITIES of the massively conflicted panel member, Susanna Naggie and Duke University, are deeply buried in the story.

    The title should be corrected to “Anti-ivermectin  recommendation”. The article should begin with the identities of the conflicted panel members which the NIH improperlyrefused to disclose.

    Naggie is identified elsewhere as “DCRI infectious disease expert” and “vice dean for clinical research for the Duke University School of Medicine, of which the DCRI is part” (who will initially receive $155 million).

    It strains credulity to believe that, Ms. Naggie’s own “Duke University was the only institution in the country that met the criteria for the study, according to the NIH”.

    Readers often don’t read beyond the title and the first few paragraphs, which need to clearly summarize the story.

  3. Thank you so much for this article Peter. Medicine-For-Profit has now become the medical standard for the so-called health care agencies overseeing drug and medical procedure approvals. Uncovering Susanna Naggie’s conflict of interest is, sadly, no longer shocking to me. What can be done? How do we, as private citizens, combat this lack of accountability? There are good and decent people working in the health agencies but are likely shackled by the fear of losing their positions or jobs. That is a valid concern. As a retired older women, I can speak openly but not everyone has this luxury.

    1. Ivermectin is already tested, approved and licensed.

      It does not need any EUA. We already know it works for covid-19.

      Covid kills. The standard rules for balancing risk/benefit apply. Wait for another trial? To test what? And how? Is medical curiosity sufficient to allow thousands/millions more to die? It is unethical, knowing what we know, to conduct an RCT with a placebo, allowing people to suffer and potentially die. Then there are the design limits of the study, which often restrict the level and frequency of dosing to a range that is not optimal for the patient’s wellbeing. Studies are oft designed, not to refine our understanding and science, but to fail and create illusions of uncertainty of efficacy and/or safety.

      Doctors have a right to prescribe ivermectin now.
      Doctors have a responsibility to prescribe ivermectin now.
      The studies on this to date are more than sufficient to inform a doctor.
      Doctors that do not keep up with the evolving science are derelict, especially in a pandemic.
      Doctors that fails to offer effective treatment are committing malpractice, should be sanctioned and sued to the fullest extent of the law. Big Pharma might have immunity on their vaccines but doctors do not have immunity for their negligence. Denial and/or ignorance of the science is not a valid excuse, not a valid defense.

    2. It is possible the FDA would still require the ACTIV-6 trial in spite of NIH recommendation of ivermectin, but the trial would be impractical. In an earlier trial on ivermectin, since the government had recommended its use, deception of subjects was required to recruit subjects to the study ( https://trialsitenews.com/jama-ivermectin-study-deception-of-study-participants-is-publicly-confirmed/ ). A similar situation arose in a trial of hydroxychloroquine. The trial was started following the government endorsement of that treatment option. In that case, the investigator denies the use of deception in recruiting study subjects but there is evidence that that is the case ( https://trialsitenews.com/how-did-together-recruit-to-a-trial-of-hydroxychloroquine-amidst-widespread-use/ ).

  4. @Ms.Pitre If someone on the NIH or another regulatory panel holds stock in a pharma company which benefits from a recommendation by the panel then that would be a conflict of interest, which may or may not be legal – but possibly influential and unethical.

    Not saying that this occurred – only trying to show what you may be missing.

    1. Thanks for your reply – it was the original headline that was confusing. It has now been fixed to read, “non recommendation.”

      I think that a few others commented on the headline too – the association with the word “recommendation” is that it is positive or an endorsement.

  5. With all due respect, the headline is confusing. When I first saw it on Twitter, it sounded like someone benefitted from recommending ivermectin. In fact, the researcher potentially benefitted by agreeing only to a neutral stance. Am I missing something?

    1. The researchers are getting millions. If they accepted the evidence that was presented and admitted ivermectin was useful, it would negate the need for yet another study on it.

      1. Thanks for your reply – it was the headline itself that tripped me up. It has now been rectified read “non recommendation.” This is important, as when it was posted elsewhere, the headline was the only part showing. If someone only read headlines, they would have been misled.

    2. It was a sole source award to a specific institution that employed this woman.
      The only thing missing is the requested vote on the issues.

      “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.”