An Urgent National Security Message to US Senator Chuck Grassley: On Treatment of COVID-19 Disease Before Critical Illness Sets In.

United States Senator Chuck Grassley (R-OH) has tested positive for COVID-19. By virtue of the age group to which he belongs, he is at extremely high risk of developing severe or critical COVID-19 disease or dying. It is my sincere hope that the senator is able to see that one of our most likely effective generic prescription drugs has been locked away in an artificial market silo by monied interests in Pharma — as America burns.

Honorable Senator Grassley,

I write this urgent letter to you in friendship, and in defense on the United States — and I write it in my capacity as an American physician, cellular immunologist and public health advocate.

I was extremely concerned, this morning, to read in the WSJ that you have contracted the COVID-19 infection.

As you know, because of your age, in the next several days you are at extremely high risk of becoming severely ill and hospitalized — your risk of mortality is unfortunately high. You have all of my prayers for a good recovery.

I feel obliged and compelled to inform you of a therapy that is not only highly likely to save your life, but is also very likely to protect a significant proportion of Americans, who are almost certainly scheduled to die from COVID-19 disease in the next several months.

I am writing to inform you that the mechanism through which COVID-19 disease causes severe illness is a hyper-inflammatory immune response, caused by cells in your immune system known as T-cells and Macrophages.

I would like you to know, and to specifically consider, that we have access to a highly specific generic drug that is well-known to safely and effectively dampen activation of these cell populations. This generic prescription drug is cyclosporine.

Cyclosporine is a generic, which over the past 40 years revolutionized the treatment of a a variety of hyperimmune/autoimmune diseases and transplantation — specifically by dampening the activation of the exact cell types, which are hyperactive in COVID-19 disease: T-cells and Macrophages.

Dr. Janet Woodcock, a leading member of OWS, has been aware of the possibility that cyclosporine is highly likely to be an effective therapy against COVID-19 inflammation. Despite her awareness and best attempts, OWS has failed to place sufficient priority on this drug because of its status as a generic.

But, despite having all these key pieces of information, the NIH and OWS have not acted to focus on this vastly available and generic drug in their discovery and development process thus far. As an immunologist, I know that this dangerous omission has been a serious national security blunder on the part of the NIH and OWS leaderships — caused specifically by the fact that no monied corporate Pharma interests stood to capitalize on this generic drug. As you know, our economics does, indeed, have significant sway over our government’s activities. In the case of generic drugs for treatment of COVID-19 disease, this economic sway is a disastrous problem that has restricted nimble and feasible moves to help save lives in the United States robustly over the past 9 months — specifically using the well known generics in our pharmacological arsenal.

Sadly, it is because cyclosporine is a generic prescription drug that it does enjoy the same level of attention as some “sexy and expensive” TradeMarked drugs, despite the clear fact that it is almost certainly “on target” with COVID-19 disease.

Nonetheless, despite some serious resistance to focusing on this immunomodulatory generic at the level of the NIH and OWS, two successful clinical trials of this drug were launched at The Hospital of the University of Pennsylvania, by Professor Carl June, and Baylor College of Medicine, by Professor Bryan Burt. These trials are currently enrolling and have been slowed by competition from some monied drugs with a far less robust rationale for use — and a few academics with too narrow a vision on cellular immunological principles.

As you, personally, are now highly likely to become symptomatic with COVID-19 disease within the next few days, and are also at a far higher risk of mortality from COVID-19 hyper-inflammation, I want to respectfully recommend that you consider taking cyclosporine within a week of your symptoms starting — and especially if your symptoms are non-remitting.

Professor Carl June at Penn initiated a clinical trial of cyclosporine for treatment of COVID-19.

Certainly, if you are hospitalized with worsening COVID-19 disease compromising your respiratory tract, I would recommend that you immediately begin a regimen of dexamethasone, Remdesivir and cyclosporine - This, in order to dampen hyperimmunity and inhibit the virus’ replication. This regimen is the one being used successfully by Professor Carl June’s clinical trial at Penn.

Senator Grassley, the Regeneron antibodies may be your first thought as an experimental therapy. But I’d like you to consider that these antibodies will only serve to effectively neutralize the SARS-CoV-2 virus, if used very early in the course of infection.

Senator Grassley, I cannot emphasize enough how much of a market and regulatory failure cyclosporine’s blockade from the mainstream of OWS’ COVID-19 therapeutic effort has been. But it is not too late. This generic prescription drug not only exists in a well-lubricated supply chain available to the vast majority of Americans inexpensively, on a daily basis, it is also very literally a “lock-and-key” fit with COVID-19 pathology.

Professor Bryan Burt at the Baylor College of Medicine started a clinical trial of cyclosporine for treatment of COVID-19 disease.

I do believe that this generic prescription drug deserves your immediate urgent attention — both personally as a susceptible infected citizen, and as a government leader whose voice will very certainly free some of our most promising generic drugs from their artificial man-made economic silos. The market failure to do so spontaneously in the current national emergency is simply a travesty against the United States — from within!

Here, I urge you to immediately communicate with Professor Carl June, or professor Bryan Burt, about their clinical trials of cyclosporine at The University of Pennsylvania and Baylor. I also want you to know that I would personally be more than happy to discuss this drug with you myself — and to even it prescribe it for off-label use.

I do wish you health and a fast recovery from COVID-19 disease.

Yours with respect, in friendship and in defense of the United States and global public health,

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