An Urgent Message to President Biden and Members of The Biden COVID-19 Taskforce: On Cyclosporine

President Biden’s COVID-19 task force has an opportunity to recognize that the NIH’s therapeutic search response to COVID-19 has vastly underplayed the role of inflammation as COVID-19’s dominant “kill-mechanism”. At this late hour, this task force’s clarity on the role of inflammation in the thousands of American deaths daily, could balance our nation’s therapeutic approach to COVID-19 disease.

Honorable Mr. President and members of the Biden task-force,

I write this public letter to you on this November day, as yesterday our nation reached another tragic milestone during the COVID-19 pandemic: 180,000 new Americans infected in a single day!

I am writing to you as an American physician, a cellular immunologist and a public health advocate.

With this letter I am specifically informing you that our nation’s efforts against COVID-19 on the therapeutic front have been radically imbalanced away from anti-inflammatory drugs. This, despite the fact that the only partially effective therapeutic agent against COVID-19 is the anti-inflammatory drug, dexamethasone. But, as you know, even this drug was not an American contribution to COVID-19 therapy, it was a British one.

Professor Carl June at Penn is guiding a trial of cyclosporine for treatment of COVID-19 disease in hospital inpatients.

The error in strategic scientific thinking about COVID-19 disease in the United States has been the NIH’s prejudice against anti-inflammatory therapy, and in favor of anti-replication, virus neutralization and vaccine agents. Of course, I am NOT critiquing the latter focus. Anti-viral replication, neutralization and vaccination are critical components of a cogent defensive strategy against COVID-19 — but the American strategic blunder is that: NIH’s efforts to treat COVID-19 disease, as a dominantly inflammatory disease, have been dangerously anemic, at best.

Here I write you to specifically highlight the potential critical importance of immediately focusing on the inexpensive and widely available generic drug, cyclosporine — This, as a reasonably safe and very well-known therapeutic agent, whose transient use, like an “antibiotic” (i.e., a 5–7 day oral course), is highly likely to curb progression of COVID-19 hyper-inflammatory disease to critical illness.

Importantly, cyclosporine resides in a well-lubricated supply chain in the US, already funded by the prescription insurance plans of the vast majority of Americans — literally every corner CVS or Wallgreens can supply a 7 day course of this drug to ANY patient for whom it is prescribed at somewhere around $20 per regimen. What’s more, is that cyclosporine is globally scaleable.

Professor Emily Blumberg is the lead clinical PI on a clinical trial of cyclosporine at the Hospital of the University of Pennsylvania.

Sine last April, I have been engaged in a serious public health campaign to highlight the likely need for this drug to be quickly tested and deployed — using our conventional “evidence-based” and emergency mechanisms. Unfortunately, however, a combination of competition with monied drug choices in the US and professional prejudices in favor of anti-viral replication and neutralization agents has introduced resistance to progress on cyclosporine.

But, irrespective, we have managed to initiate two small clinical trials, which are now recruiting COVID-19 patients for testing of cyclosporine — one at the University of Pennsylvania, under direction of Professors Carl June and Emily Blumberg, and a second at Baylor College of Medicine, under the guidance of Professor Bryan Burt. A grand total of only FOUR, yes FOUR, patients have been enrolled in these trials since June 2020. Anemic, indeed! All four patients were discharged from the hospital within 5 days and are doing quite well now.

Professor Bryan Burt is the lead clinical PI on a trial of cyclosporine in patients with COVID-19 disease at the Baylor College of Medicine in Houston, TX.

Simply put, America is insufficiently attuned to the fact that COVID-19’s “kill-mechanism” is driven by a hyper-inflammatory response mediated by T-cells and Macrophages. The exact cell subsets whose activation can be efficiently modulated by the well known drug we call cyclosporine. A drug, which most clinicians know revolutionized the worldwide treatment of hyper-inflammatory and autoimmune diseases — and organ transplantation. This, by dampening the vigor of T-cell and Macrophage activation.

Dr. Janet Woodcock of OWS and Dr. Anthony Fauci are both aware of the potential critical importance of this drug in curbing COVID-19 hyper-immunity. However, because of monied priorities driven by corporate players in Pharma, and because of Dr. Fauci’s past success with anti-replication agents in the HIV/AIDS playbook, a major focus on anti-inflammatory agents, prominent amongst them cyclosporine, remains dangerously absent from our American strategic approach.

Dr. Janet Woodcock, a leading regulator and rheumatologist, at Operation Warp Speed has been aware of the high likelihood that cyclosporine would block progression of COVID-19 hyper-inflammatory disease since March 2020.

I write to inform you, as a cellular immunologist and clinician with experience in the use of immunomodulatory drug agents like cyclosporine, that it is more than highly likely that a combination of dexamethasone and cyclosporine will block the progression of COVID-19 disease in a large majority of patients with unremitting disease, who are moving towards critical illness daily across America.

At this late hour in the American pandemic, I ask for your urgent voice of support in engaging cyclosporine as a defensive weapon. And I can only hope that you have the clarity to see that this major defensive weapon in our generic pharmaceutical arsenal remains unacceptably siloed — as American lives begin to burn at an unprecedented rate daily.

I ask for your urgent voice of support in casting cyclosporine into the limelight of professional, public and regulatory discourse as a likely candidate for blockade of COVID-19's deadly inflammatory phase.

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

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