An Urgent Letter to America’s Press Leaders: Operation Warp Speed’s Critical Blunder In Confronting COVID-19.

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Leaders of the American free press are aware of a deadly strategic blunder on the part of Operation Warp speed and its leadership: The anemic focus on COVID-19’s “kill-mechanism” — hyperinflammation.

Friends to the public,

I am writing to you for your record, as leaders of America’s free press, to inform you about what is highly likely to be the gravest strategic blunder by Operation Warp Speed’s (OWS) therapeutic response to the COVID-19 pandemic. The consequence of the herein described error, and its continuation to date, has been and will be the continued deaths of thousands more American citizens and residents over the next several months to year, from COVID-19 disease.

The OWS blunder is simply this: that despite quite clear emerging clinical and scientific evidence regarding the inflammatory “kill-mechanism” activated by SARS-CoV-2, as early as March 2020, OWS’ strategic approach, functionally and fundamentally, ignored COVID-19 inflammation as a dominant target of therapeutic development and intervention. This is OWS’ single catastrophic strategic error that is continuing to compromise America’s health and national economic security during this pandemic.

Instead, our nation’s top health experts and leaders focused OWS’ firepower on developing vaccines, expensive and non-scaleable neutralizing monoclonal antibodies and trademarked anti-replication agents — while almost entirely ignoring COVID-19’s inflammatory “kill-mechanism”, with a response that at best can be characterized as anemic.

Of course, you all now know that the anti-replication agents (e.g., Remdesivir and Kaletra) are proving less than effective. You also know that the neutralizing agents like Regenron’s mAb cocktail is not rapidly scaleable in any meaningful way — nor do we even know if it is effective in treating COVID-19 disease or when it may be most effective to use it.

Of course, the OWS’ vaccine effort with corporate partners like Pfizer, Moderna and AstraZeneca is likely to be the most effective dimension of the agency’s efforts. Certainly the rapid development of the vaccine is a dramatic feat of our modern technology and science — and I do believe that eventually these vaccines will protect lives.

But, in truth, you all know that, even now, a generally available vaccine is at least months away — as thousands of Americans, and many more globally, perish daily.

The COVID-19 vaccine is simply NOT ready for the pandemic’s primetime, even though it is now primetime in America. The slope of the pandemic’s rise in our nation has simply decimated the speed of vaccine development — such that in Nov 2020, as COVID-19 cases begin to surge massively, the vaccine is still only an emerging point of optimism: Literally, a mirage on the horizon, in a desert that is killing thousands of people as I write this letter to you in November 2020.

Please understand that I am not critical of what OWS and its leaders have accomplished with vaccines, neutralizing agents or anti-replication drugs— this has been a valorous effort in the midst of unprecedented public health disaster. BUT, I am stating emphatically on this record to you, that OWS’ anemic focus on SARS-CoV-2’s inflammatory “kill mechanism”, has been and continues to be a deadly blunder — one, which will cost thousands of more American lives.

I would again highlight for you the fact that the only real, but just partially effective, therapeutic agent for treatment of COVID-19 disease is the generic steroid drug, dexamethasone — an anti-inflammatory agent! And this drug was not even an American discovery — it was a British one.

America is NOT focused on COVID-19’s inflammatory dimension, which is its dominant pathological mechanism and is the Achilles heel of the hundreds of thousands of our countrymen, who have fallen to COVID-19 disease so far.

Fundamentally, I am certain that this OWS error is a result of the leadership’s prejudiced scientific tunnel visioned focus away from COVID-19 inflammation. A subconscious prejudice that is acted on by the OWS leadership, because the successful experience with the HIV/AIDS pandemic guided Dr. Fauci’s team, dominantly, towards anti-replication agents, neutralizing antibodies and vaccines — away from the inflammatory component of COVID-19 disease, which is what kills patients.

It should be sobering to you that none of America’s current OWS developed arsenal — not the anti-replication agents, not the neutralizing mAbs, not the vaccines — are helping America in any real way on this November day, 9 months after the pandemic started to ravage our nation — and as we stand poised to be shaken by many more losses in the aftermath of our Thanksgiving and Christmas holidays.

Yet, since March 2020 it has been quite clear from an immunological clinical perspective that COVID-19 disease is a hyper-inflammatory disease, which involves dominant activation of T-cells and macrophages in patients with unremitting or worsening COVID-19 disease. It was clear then, that anti-inflammatory agents would almost certainly be critical to successful therapy. AND, it was clear, from a scientific and clinical perspective, that the well-known generic drug, cyclosporine, is highly likely to provide a “lock-and-key” fit for the type of deadly inflammatory pathology SARS-CoV-2 sets off in the infected patient.

Here, for the record, it is my prognostication that use of the generic drug, cyclosporine, in unremitting or worsening outpatient COVID-19 disease - and a combination of cyclosporine and dexamethasone in unremitting moderate/severe inpatient COVID-19 disease — will effectively block disease progression in a large proportion, if not the majority of COVID-19 patients.

Many of you and your colleagues in the press are aware of the efforts to highlight and trial cyclosporine, nationally and internationally, and to guide OWS focus onto inflammation as the target of COVID-19 therapy. You are also aware that so far, these efforts have been muted and anemically received by OWS, most academic leaders and the press — challenged with astonishing efficacy by monied drugs, professional prejudices and ego interests.

But at this juncture, the press has a choice to make.

Will the press remain conservative, traditional and establishment bound — only to report from the safe rear-view mirror of events transpired, and tragedies consumed? Or will the press see its role in projecting, to our democracy and our professions, this terrible strategic blunder being currently committed by our nation’s top COVID-19 czars in real time?

OWS, Dr. Fauci, and others have almost entirely and functionally ignored COVID-19’s inflammatory “kill-mechanism” for the past 9 months — on an assumption that anti-replication agents and neutralizing antibodies would be superior treatment AND with the hope that our technology in vaccine development would outpace the virus. This approach has proven incorrect and suboptimal as you are bearing witness — and it is a strategic public health blunder that will cost thousands more lives now.

My respectful suggestion and request to you, as leaders of the free press, is to focus immediately and squarely on the need for urgent national action on generic anti-inflammatory therapeutics, and especially those with mechanistic specificity for treatment of COVID-19’s immunological pathology. As you know, chief among these is the well-known, safe, effective, mechanistically specific, and broadly available and inexpensive generic drug, cyclosporine.

As our economy stands poised to take a second, perhaps irreversible, hit from COVID-19, America does not have more time to waste ignoring COVID-19’s inflammatory “kill-mechanism”.

I write to you and your colleagues in the press in friendship and in defense of the United States and global public health,

Hooman Noorchashm MD, PhD (For Amy, our children and the others).

e-mail: noorchashm@gmail.com

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.

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