The Ivermectin recommendation was a deception

The Ivermectin recommendation was a deception

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.

Responses

  1. The proper NIH guideline would have read, "Currently there is tentative evidence of moderate strength to suggest that ivermectin may prevent the acquisition of Covid-19 among treated health care workers, shorten the time to viral clearance and clinical recovery, shorten hospital stay, and reduce mortality. These outcomes are not firmly established at this time, and several additional randomized trials of larger size are expected to be completed within the next two months that could change the expert panel’s conclusion. At this time the panel is split about whether to recommend this medication."

  2. Correction to my previous comment (no edit feature available):
    Neither the NIH nor CDC approves pharmaceuticals and while these agency’s recommendations may be persuasive, they have no force of law.

    1. This is technically correct but it doesn’t paint the whole picture. In the US, most physicians are bound by employment contracts to follow Guideline therapy. This is true of almost all inpatient physicians but also of most medical groups too. Therefore, the NIH Treatment Guidelines have an indirect result in forcing most physicians to comply under contract law.

      1. Mr. Elkins:
        Generally, my practice doesn’t include representing physicians or their adversaries, so you may be the more informed of us on this issue. However, I have practiced a fair amount of employment and contract law, and to my knowledge, very few, if any, contracts between providers and their employers, partners or contracting parties, express specific requirements as to which off-label medications are permitted for physician prescription.
        By example: colchicine, approved by the FDA for the treatment of gout, is also prescribed off-label by practically every cardiologist for the treatment of Post-STEMI Pericarditis (aka, "Dressler’s Syndrome.") See, https://reference.medscape.com/drug/colcrys-mitigare-colchicine-342812 But, the NIH has nothing whatsoever to say about the issue. It’s prescribed simply because it works.
        So, when I read or hear that Ivermectin is somehow subject to a different set of standards, my "legal radar" starts searching for the reason why this is so. My opinion at this point is that something is missing from the discussion. I don’t know what that something is, but rather than my engaging in "finger pointing," I prefer to ask questions, seek answers and encourage action — the latter being the usual reason why things in the real world, don’t get done.
        In conclusion, I’ve just checked the NIH website, and I notice the following edit: "We are currently updating the Ivermectin section of the Guidelines. Pending release of the updates, please see the COVID-19 Treatment Guidelines Panel’s Statement on the Use of Ivermectin for the Treatment of COVID-19."
        So, perhaps some action is about to be taken. Stay tuned….

  3. Dissent:

    Neither the NIH nor CDC approves pharmaceuticals and while these agency’s recommendations may be persuasive have any force of law.
    Only the FDA approves pharmaceuticals for lawful use, and the FDA formally recognizes "off-label" use of approved pharmaceuticals. See, https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label And, in the USA, one in five prescriptions are written for off-label use. See, https://www.ahrq.gov/patients-consumers/patient-involvement/off-label-drug-usage.html
    Based on the foregoing, there is no legal prohibition against prescribing Ivermectin – an FDA-approved medication – off-label to treat COVID-19. The prohibition is in the collective minds of the medical community, alone.
    "Finger pointing" is a common means of deflecting responsibility. Physicians are highly trained and compensated for their expertise. If anyone is to blame for the failure to use Ivermectin in the treatment of COVID-19, then it is the physicians who refuse to prescribe its use. This, of course, assumes that Ivermectin is effective in treating COVID-19 – a question which could have been answered by now were the medical community to "open its wallet" and conduct a randomized controlled trial, rather than waiting for a government agency to approve and pay.

    Note: It seems to me that some wealthy philanthropist could be motivated to pay for such a trial. I wonder why no one seems to have tried that route? Rich people love attention.

  4. The following statement in the article is misleading to a layperson reading it:
    "Federal government agencies are not required to answer questions in response to FOIA requests."
    It makes it sound like the NIH did not comply to the FOIA and that the FOIA doesn’t apply to them. Please update the article to make it clear that the specifics of the FOIA does not require the answering of questions, it specifically relates to request of documents, as they state in their reply:
    "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."
    On reporting on this we must be extremely careful to not misrepresent anything. In fighting against this crime against humanity we cannot make any misleading claims or the mainstream media will make all of us out as conspiracy theorists and flat earthers.

  5. At this point in the pandemic, I don’t know if the response by our health care ‘authorities’ is tragic or farcical. Although the NIH disavows any responsibility by stating that their Covid-19 Treatment Guidelines are "not a mandate," they damn well know that the vast majority of ‘physicians’ in the US follow them to a tee.
    I work with ‘doctors’ and have ‘doctors’ in my family. Their response to this pandemic has been a real eye-opener for me. The vast majority of them simply do not want to think. They want to be told by Fauci and NIH what to do. The vast majority of them won’t even look into the evidence for ivermectin for Covid-19. If it’s not in the NIH guidelines, they won’t bother. They would rather do nothing, and watch patients get hospitalized and die, than to exercise their own judgment and look into a drug like ivermectin. Their fear of being different in any respect from peers is all-consuming and stultifying. It’s perfectly ok in their minds to be wrong, and to do wrong, as long as all of their peers are wrong in the same way.
    If ivermectin finally gets adopted as a solution to the pandemic, as it should, it will be in no part due to the so-called medical profession in the so-called advanced economies. The so-called medical profession in the so-called advanced economies no longer produces physicians for the most part, with rare exceptions like Dr. Kory, Dr. Marik and the others in the FLCCC. It produces unthinking, cowardly, sanctioned-protocol followers.
    If ivermectin finally gets adopted worldwide as a solution to this pandemic, it will have been a gift from the doctors in the low- and middle-income countries, and the indefatigable effort of Dr. Kory, Dr. Marik and the FLCCC. The trial results from these low- and middle-income countries have finally gotten the attention of the WHO, and I do expect that the WHO will at some point do the right thing and recommend ivermectin for Covid-19. It remains to be seen whether the NIH and our other health care ‘authorities’ can be shamed into doing the same.
    After all, the availability of a cheap, effective prophylaxis and treatment will put a lot of vaccine sales at risk, not to mention those for remdesivir and the monoclonal antibodies. And our health care ‘authorities’ in the US have demonstrated by their response to this pandemic that they are cheerleaders for industry, above all else.

  6. At this point in the pandemic, I don’t know if the response by our health care ‘authorities’ is tragic or farcical. Although the NIH disavows any responsibility by stating that their Covid-19 Treatment Guidelines are "not a mandate," they damn well know that the vast majority of ‘physicians’ in the US follow them to a tee.
    I work with ‘doctors’ and have ‘doctors’ in my family. Their response to this pandemic has been a real eye-opener for me. The vast majority of them simply do not want to think. They want to be told by Fauci and NIH what to do. The vast majority of them won’t even look into the evidence for ivermectin for Covid-19. If it’s not in the NIH guidelines, they won’t bother. They would rather do nothing, and watch patients get hospitalized and die, than to exercise their own judgment and look into a drug like ivermectin. Their fear of being different in any respect from peers is all-consuming and stultifying. It’s perfectly ok in their minds to be wrong, and to do wrong, as long as all of their peers are wrong in the same way.
    If ivermectin finally gets adopted as a solution to the pandemic, as it should, it will be in no part due to the so-called medical profession in the so-called advanced economies. The so-called medical profession in the so-called advanced economies no longer produces physicians for the most part, with rare exceptions like Dr. Kory, Dr. Marik and the others in the FLCCC. It produces unthinking, cowardly, sanctioned-protocol followers.
    If ivermectin finally gets adopted worldwide as a solution to this pandemic, it will have been a gift from the doctors in the low- and middle-income countries, and the indefatigable effort of Dr. Kory, Dr. Marik and the FLCCC. The trial results from these low- and middle-income countries have finally gotten the attention of the WHO, and I do expect that the WHO will at some point do the right thing and recommend ivermectin for Covid-19. It remains to be seen whether the NIH and our other health care ‘authorities’ can be shamed into doing the same.
    After all, the availability of a cheap, effective prophylaxis and treatment will put a lot of vaccine sales at risk, not to mention those for remdesivir and the monoclonal antibodies. And our health care ‘authorities’ in the US have demonstrated by their response to this pandemic that they are cheerleaders for industry, above all else.

    1. Exactly, however a lot of doctors are rebelling, but their voices are suppressed to make it look like there is a consensus among healthcare practitioners. In many places of the world large amounts of doctors have publicly and officially supported the approval of/legalization of Ivermectin by open undersigned letters.
      These doctors face discrimination and very real threats to their livelihood for speaking up against the powers that be, but their names are not redacted. They are acting in private capacity, but their names are not redacted.
      How is it possible that names of doctors working in a public capacity making public policy decisions can be kept private? Are these names redacted because they have extreme conflicts of interest? Probably, they probably found 2 doctors with minimal conflict of interest to keep unredacted.
      The real professionals that’s been largely quiet, or at least I have not heard their voices, are those from the medical research community. It makes sense though, they are further removed from the death and suffering and they are closer to the money/funding from the pharmaceuticals. They are also more interested in new shiny toys, than old drugs that somebody else already got the nobel prize for.

    2. Well said Harold Kang.
      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.”The "providers" who are making the decisions are actually the "corporate interests" who regulate the options for docs. They can "stick to the program" or be or fired.
      Dr. Kory was way too outspoken for those "corporate interests". They didn’t feel they could control him so they told him to fall in line or be fired. As I understand it, he chose not to accept those terms and was fired.
      With the continuing consolidation of Medical care in the USA there is little or no room for doctors who want to actually practice medicine vs administering the Faustian/corporate deal.

    3. Well said Harold Kang.
      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.”The "providers" who are making the decisions are actually the "corporate interests" who regulate the options for docs. They can "stick to the program" or be or fired.
      Dr. Kory was way too outspoken for those "corporate interests". They didn’t feel they could control him so they told him to fall in line or be fired. As I understand it, he chose not to accept those terms and was fired.
      With the continuing consolidation of Medical care in the USA there is little or no room for doctors who want to actually practice medicine vs administering the Faustian/corporate deal.