COVID-19 and the Opening of America: Intravenous, High Dose L- Carnitine with Fatty Acids Clinical Study Treatment Proposal and Rationale for Pre-Ventilator Patients Which Can be Immediately Implemented and Help Re-0pen Our Country
Stephen L. DeFelice, M.D., Chairman
Private Industry and government resources have dramatically responded to the COVID-19 pandemic by initiating numerous clinical trials.
Also, they are being swamped by reviewing multiple other proposed clinical approaches, straining such resources.
At a recent Senate Hearing attended by Dr. Anthony Fauci, NIH infectious disease expert, FDA Commissioner, Dr. Stephen Hahn, and other authorities, it was made clear that effective therapies will not be available on the near horizon. For these reasons and for reasons of the critical importance of speed, FIM has reluctantly decided to publish outside of the normal channels a unique clinical approach based on a substantial number of published laboratory and clinical studies for interested parties to evaluate both here and abroad. If successful, it will open the door for accelerating the opening of America.
Rationale and Clinical Study Outline
Aimee Cunningham, a highly respected medical journalist, wrote a review article in Science News, April 11, entitled, WHY COVID-19 is bad for the heart. Bottom line is that hypertensive, diabetic and other cardiovascular disease COVID-19 patients are at higher risks than others. She mentions that the protein, ACE2, the virus receptor, is, in addition to the lungs, also on heart cells and the linings of blood vessels. It was also proposed that, generally speaking, respiratory infections can increase cardiac workload.
Now to L- carnitine: I, as a physician, brought carnitine into the U.S. in 1965 and over the years managed to guide it to obtain FDA Orphan Drug approval for Primary Carnitine Deficiency, a fatal disease in children with cardiomyopathy due to decreased cardiac carnitine levels, and also for renal dialysis patients who have general carnitine deficiency.
It’s important to note that it’s extremely safe and given to many thousands of patients of all ages both here and abroad.
Its primary mode of action is to transport long chain fatty acids into the mitochondria to generate ATP or energy. It protects the heart during a number of ischemic and other cardiac states. Major James Vick and I conducted a number of studies ranging from isolated Langendorff heart to in vivo models at WRAIR, the Walter Reed Army Institute of Research, including septic/toxic shock ones. Fatal doses of E.coli toxin, Russell’s viper venom, palytoxin, a South Sea coral toxin, and the anti-cancer drug, doxorubicin, were dramatically reversed by L-carnitine administration. Previous to these studies, L-carnitine was shown to reduce mortality in guinea pigs caused by diphtheria toxin. At WRAIR and other academic research laboratories, L-carnitine reversed cardiac failure and arrhythmias.
Regarding onset of action– carnitine acts quickly not only in laboratory but also in clinical studies. For example, there are three published clinical pharmacological studies such as atrial pacing in patients with coronary artery disease, which reported L- carnitine’s acute anti-ischemic effect.
For the aforementioned reasons, it’s proposed that, as adjunctive therapy in conjunction with standard therapies, the administration of the combination of high dose intravenous L-carnitine and fatty acid infusions can improve cardiac performance as well as protecting other body organs against ischemia/hypoxia including the lung. With respect to the latter, L-carnitine does reach the lungs. For example, it significantly reduced lung damage in biliary obstructed Wistar-Albino rats.
It’s encouraging to note that water-soluble substances such as carnitine, that are efficacious in many research models, have a reasonable probability of success in clinical conditions such as with COVID-19.
Regarding the clinical study, I would propose as treatment, an open treatment protocol in both cardiac and non-cardiac risk pre-ventilator hospitalized patients given both high dose intravenous L-carnitine along with intravenous fatty acid containing infusions. The objective would be to detect an impressive acute/subacute effect. If encouraging, the combination can be administered to all hospitalized patients significantly diminishing the mortality rate which will significantly help in the opening of our country. It will not help, however, in non-hospitalized patients where such treatment is not available.
It’s also encouraging to note that both formulations are in the pharmacy immediately available for the study eliminating the problem of time loss in gearing up for production.
Additional comments: I mentioned the following not as sufficient support in themselves for initiating the clinical study but only to report such studies for overall consideration. Because of L-carnitine’s ubiquitous distribution in most body cells, there are numerous promising but limited studies in a variety of different specialties and conditions. For example, there are data reporting that L-carnitine reduces inflammatory mediators in intestinal and coronary artery diseases. Also, it’s reported that it inactivates the Hepatitis C virus, which like COVID-19, is an RNA virus. Regarding fatty acids, it’s been reported that fatty acids inactivate envelope type viruses. Also, certain viruses thrive on glucose and the combination may force them into a fatty acid environment.
In conclusion, the aforementioned and other data clearly support initiating an acute/subacute clinical trial of the combination not only to treat patients but to help open America and elsewhere.
Stephen L. DeFelice, M.D.
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October 23, 2002 commentary by Stephen L. DeFelice, M.D.
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July 4, 2002 commentary by Stephen L. DeFelice, M.D.
The Moral Dilemma of Embryonic Stem and Fetal Cell research: A Proposed Solution
June 2002 commentary by Stephen L. DeFelice, M.D.
The Nature of the Nutraceutical Revolution in the Year 2000
January 1, 2000 commentary by Stephen L. DeFelice, M.D.
The Dietary Supplements, Special Foods and Diets Dilemma
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January 7, 2000
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October 12, 1999 commentary by Stephen L. DeFelice, M.D.
Bill H.R.3001 – The Nutraceutical Research and Education Act
Oct. 1, 1999 (introduced to Congress)
This bill is to amend the Federal Food, Drug, and Cosmetic Act to promote clinical research and development on dietary supplements and foods for their health benefits; to establish a new legal classification for dietary supplements and foods with health benefits, and for other purposes.
FIM Rationale And Proposed Guidelines For The Nutraceutical Research & Education Act – NREA
Nov. 10, 2002
By Stephen L. DeFelice, M.D.
Presented at FIM’s 10th Nutraceutical Conference: Nutraceuticals & Pharmaceuticals Taken Together: A New Health Sector. Plus: A New FIM Congressional Proposal: The Nutraceutical Research & Education Act – NREA
Oct. 30, 2002
FDA announced it intends to seize cholesterol lowering Benecol margarine and ban it as a dietary supplement.
- FIM’s Principles for Sufficient Evidence for Nutraceutical (Medical-Health) Claims
Because of the absence of guidelines regarding what is sufficient evidence for making claims FIM has proposed principles which are acceptable to most authorities and should be adopted by corporations as a guideline to making claims. Dr. DeFelice believes there is little or no difference between a health and medical claim.
- FIM’s Response to the FDA Advanced Notice of Proposed Rulemaking (ANPR) on Medical Foods
- April 10, 1997
In a letter to Dr. Yetley of the FDA Dr. DeFelice applauds certain aspects of the ANPR but also strongly warns that certain proposals contained therein will have a powerful negative impact on nutraceutical research.
- FIM’s Response to the Draft Document of the President’s Commission on Dietary Supplement Labels Regarding Dietary Supplements (DSHEA)
July 24, 1997
In a letter to Dr. Fisher, Executive Director, Commission on Dietary Supplement Labels, Dr. DeFelice proposes ways in which to improve DSHEA which involve two issues — a. the need to correctly disseminate truthful medical – health claims and b. the need to encourage research to generate the data to support the medical – health claims.
- The Need For a Research-Intensive Nutraceutical Industry:
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(The Claims-Research Connection)
A FIM Proposal – July 1996
The cardinal principle of FIM is that nutraceutical research can only thrive if our system reasonably permits institutions, particularly corporations, to make medical-health claims based on preclinical – clinical research.
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What Is the Nature & Size of the U.S. Nutraceutical Market?
A press release dated March 1994
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- Nutraceuticals – Opportunities In An Emerging Market
Stephen L. DeFelice, M.D., Scrip Magazine, September 1992
Dr. DeFelice believed and still believes that the first prototype nutraceutical company has not yet been born. In this article he discusses the nature of the market and ways to approach it.
- Conference Summary
The Nutraceutical Revolution: Where Do We Go From Here?
In this conference it was concluded that there was an urgent need to modify our system in order to encourage nutraceutical research.
- Proceedings of the Symposium:
A Comparison of the U.S., European & Japanese Nutraceutical Health and Medical Claim Rules
Published in Regulatory Affairs, Vol. 5, Summer 1993
- The NutraCeutical Revolution: Fueling a Powerful, New International Market
Stephen L. DeFelice, M.D.
Presented at the Harvard University Advanced Program in Biomedical Research Management and Development in Italy, jointly organized by Harvard University Biomedical Management Faculty and Farmindustria, Associazione Nazionale dell’Industtia Farmaceutica, with the collaboration of The Foundation for Innovation in Medicine, March 1989, at Villa Olmo, Como, Italy.
- The Promise and Problems of Natural Substances in Medicine
- This volume represents the findings of a symposium held at Columbia University on May 17, 1983. It is the first of a series of symposia which will dealt with the state of the innovative process in medicine.