Two Reasonable And Specific Therapies for COVID-19 Disease Are Being Blocked From The American Public: Cyclosporine & Fluvoxamine.
I ask the reader to please read this article in full — and to pass this information on to any persons who might be suffering from worsening COVID-19 disease, outside the hospital setting in the United States.
As cases of COVID-19 begin to surge across the United States this Fall and Winter, the fact is that the American public does not have access to any reasonable therapy to block disease progression in the outpatient setting.
This is because of a failure of our healthcare leadership to focus on blocking the inflammatory phase of COVID-19 disease, which is what lands patients in the hospital and in ICUs.
Additionally, the dominant pre-COVID-19 approach of the Pharma industry aimed at mining money from drugs has been catastrophically slow in testing reasonable drugs that can be accessible by millions of Americans — and globally.
These are both intellectual and moral failures on the part of our American healthcare system.
To compound the problem, the vast majority of individual physicians, who have beneficent intent, operate in a fear-based and liability driven bubble, where they need to have the protection of institutional “evidence-based” methodologies.
But, these pre-COVID-19, “evidence-based” methods are far too slow for the speed of this pandemic — and, worse, these methods are commandeered dominantly by money and professional ego interests, to America’s peril.
The fact is that COVID-19 disease is an inflammatory disease, mediated at its onset by T-cells and Macrophages, which are inflammatory cells.
Therefore, if activation of these immune cells is “slowed” or “reduced” using reasonable drugs as the disease starts to accelerate out of control in some, it is highly likely that we will be able block progression of COVID-19 illness to a critical state.
Here, I write to inform the American public about two generic, inexpensive and reasonably safe drugs that are hidden in plain sight. These two drugs available to most Americans at every retail pharmacy in the nation, and covered by every health insurer in America. But most importantly, these two drugs are reasonably or highly likely to block progression of COVID-19 inflammation and illness.
These drugs are the vastly available and reasonably safe, cyclosporine and fluvoxamine.
Cyclosporine is an immunomodulatory drug that is routinely used to dampen autoimmune and hyperimmune reactions in a variety of outpatient diseases involving inflammation. There are 40 years of clinical experience with the use of this drug and some prominent immunologists have been advocating for its use against COVID-19 disease.
Additionally, most major specialty groups have recommended that patients who take cyclosporine for maintenance of their outpatient disease, continue doing so during the COVID-19 pandemic. This is because most experts do not believe that there is a catastrophic risk of harm from the drug, if these patients are infected with the COVID-19 virus. Bottom line is that cyclosporine is a reasonably safe outpatient drug to be used in the setting of COVID-19 disease.
In fact, currently two clinical trials of cyclosporine are set up to gather the traditional pre-COVID-19 “evidence-based” data needed to prove cyclosporine’s efficacy in patients with moderate COVID-19 disease. The patients treated in these trials so far have experienced no adverse outcomes. But these trials are small, inaccessible to the vast majority of Americans and VERY slow to perform.
Additionally, a large observational study from Spain, recently published by The Lancet, demonstrated that cyclosporine affords a major survival advantage to COVID-19 patients (You may read this article HERE). This is an efficacy signal against COVID-19, which we cannot afford to ignore.
To be clear, the Spanish are using cyclosporine to treat COVID-19 disease. America lags behind.
Fluvoxamine is an anti-depressant drug, in common use as an outpatient generic also. It’s use to block progression of COVID-19 disease might sound surprising - and certainly from a scientific and clinical perspective, there is no precedent for its use as an anti-inflammatory agent. But, recently an observational study followed by a small Randomized Control Trial (RCT) of 150 patients showed that it may block progression of COVID-19 hospitalizations from 9% to ZERO in the 150 patients studied. So, we ought not ignore this drug, because it too is an easily available generic.
Let me be blunt to you, the reader.
Is it highly likely that as the COVID-19 pandemic ravages America and our hospital systems around the nation this year, most affected Americans will languish without any real options as outpatients — and some will progress to critical illness and death.
Therefore, because the slope of rise in COVID-19 cases is far out matching the slope of progress in developing proven therapies using our traditional pre-COVID “evidence-based” systems, we must revert to reasonable but unconventional methods to protect the outpatient population at risk of disease.
Specifically, it is my duty, as a physician and public health advocate, to inform you that both cyclosporine and fluvoxamine can be prescribed “off-label” to patients with COVID-19 disease, who wish to exercise their right to try reasonable safe, potentially effective, but unproven drugs to prevent progression of their COVID-19 disease.
Your autonomy to choose an available therapy as an informed patient, during this pandemic, is being blocked by our pre-COVID processes and by institutional paternalism in healthcare.
I write this article fully cognizant that I am proposing a non-traditional approach to therapy, which will be critiqued harshly by many of my medical colleagues who operate with an institutional or pre-COVID lens — my position will be criticized from both an ethical and safety perspective.
But, I write because I know that both these generic agents can be reasonably safe in appropriately COVID-19 candidates — and that both have a potential likelihood of being effective at blocking disease progression.
As an immunologist with a knowledge of cyclosporine’s utility in scientific and clinical settings, my personal prejudice is that cyclosporine will exert a more dominant effect on COVID-19 disease and block its progression. But, I also find myself unable to dismiss the potential efficacy of Fluvoxamine, based on the limited data we have.
In summary, I want the reader to take stock of the fact that currently NO “standard” therapy exists for treatment of COVID-19 disease in the outpatient setting before the disease becomes critical— but that two reasonably safe and likely effective and available generics are being blocked from the public by our healthcare system’s inability to quickly shift out of its pre-COVID thinking, and by fears of liability on the part of the average American physician.
Both cyclosporine and fluvoxamine are reasonably safe outpatient drugs — AND both reside in an active and easily deployable supply chain at your local pharmacy.
These two drugs ought to be deployed against COVID-19 disease with all possible speed and using all available mechanism. And most specifically, using the “off-label” approach.
At this late hour, a failure of our federal government to act comprehensively and the failure of our healthcare institutions to relinquish money interests in favor of balanced immunological science, is forcing only one option: “Off-label” use in reasonable outpatient candidates.
If you or a loved one has been suffering with COVID-19 disease for over 5 days without improving, and if you wish to have a conversation about either of these two generic “off-label” treatments, please contact me at Hooman@patientrights.org.
I write in friendship to you and in defense of the United States and global public health.
Hooman Noorchashm MD, PhD (For Amy and the others).