The Fight to Allow Doctors to “Doctor” Heads to a Virginia Court

Paul Marik, MD, one of the most highly published critical care physicians in the world and the Director of the ICU at Sentara Norfolk General Hospital, was recently prohibited by Sentara Healthcare from administering a range of highly effective COVID-19 treatments to critically ill patients—the same treatments he has successfully used to reduce COVID deaths in the ICU by as much as 50%. The result of the prohibition has been a sharp increase in patient mortality. Because Dr. Marik can no longer stand by while patients needlessly die without proper treatment, he has filed a lawsuit to allow him and his colleagues to administer the combination of FDA-approved drugs and other therapies that has saved thousands of critically ill COVID-19 patients in the last 18 months.

The Complaint—filed November 9 in the Circuit Court for the City of Norfolk, Virginia—states that Sentara Healthcare is “preventing terminally ill COVID patients from exercising their right to choose and to receive safe, potentially life-saving treatment determined to be appropriate for them by their attending physician.”

Dr. Marik is the co-founder of the non-profit organization, the Front Line COVID-19 Critical Care Alliance (FLCCC), formed in March 2020.  The sole mission of the FLCCC is to develop the most effective COVID-19 treatment protocols in the world. To date, FLCCC has developed treatment protocols for prevention, early treatment, hospital treatment, and long haul COVID syndrome.

Dr. Marik’s co-founders consist of a group of acclaimed clinical experts—including Dr. Pierre Kory and Dr. Joseph Varon who speak about their colleague, Dr. Marik, and the lawsuit below.

DR. KORY: Dr. Marik is an extraordinary clinician, possessed of stellar medical and academic credentials, and an exceptional breadth and depth of experience as a physician. More specifically, I believe that the COVID treatment protocols that he has developed and prescribed work and have saved patients’ lives.

Dr. Marik, an attending physician with widely recognized excellence and expertise, has been prevented by hospital administration at Sentara Healthcare System from using those protocols and their components and advising his patients of their safety and efficacy in accordance with his seasoned medical judgment in order to alleviate the suffering of his patients and avoid unnecessary deaths from COVID.

My own real-world experience over the past 20 months in dealing with the COVID pandemic makes it certain that the use of the MATH+ Protocol devised by Dr. Paul Marik and the FLCCC is effective. I have observed repeated changes in disease trajectories such that patients improve without need for invasive mechanical ventilation, and are thus discharged from the ICU earlier.

I have also seen patients on mechanical ventilation begin to improve with many able to be weaned off mechanical ventilation. Based on my assessment of outcomes for the roughly 150 ICU COVID patients I have treated with the MATH+ Protocol since April, 2020, use of this Protocol leads to lower rates of mechanical ventilation and death from COVID, with earlier and more frequent discharges from the ICU. These results are consistent with those experienced by my physician colleagues at FLCCC—in particular by Dr. Joseph Varon.

DR. VARON: My position at the hospitals where I have privileges has fortunately enabled me to employ any, and all effective treatments to cure COVID-19 and its effects at every stage of the disease but, most particularly, at the critical care stage when patients are admitted to hospital and/or the Intensive Care Unit (ICU).  As a result of the remarkable success our hospitals have enjoyed with such patients over the past 18 months since March 19, 2020, we have exclusively applied the MATH+ protocol, with small variations as appropriate to every COVID patient entering our hospitals and ICUs.

Over the past 18 months of our hospitals' use during the COVID pandemic, I can testify that the MATH+ protocol saves lives, and saves them in substantial numbers.  I know this first, and foremost, from my own experience in our hospital, where we were able to lower our mortality for COVID-19 patients (both critically ill and those on regular wards) beginning in March 2020 (when we began utilizing the MATH+ protocol) to 4.4% as of August 2020-- a dramatic improvement  over the national average of 22% over the same time period.

Reported mortality averages across the globe have varied widely, but our hospitals' results have successfully maintained far lower patient mortality rate—between 4.4% and 7%—to the present day. Multiple studies report much higher national mortality averages, including one such study that I participated in and published in June 2021 in the Journal of Community Medicine and Public Health Reports. That study, reviewing some 85 hospital studies worldwide, establishes an average 28-day hospital mortality rate among  COVID-19 patients of 20% nationwide, and 21% globally.  Moreover, as the study points out, because a large percentage of patients remain hospitalized after Day 28, the real average mortality rate is likely much higher. To this day—even with the advent of the "Delta variant" of COVID-19, our mortality rate has not risen above 7%.  Bottom line: our hospitals' use of the MATH+ protocol has reduced mortality of hospitalized COVID-19 patients by at least 50% below the national average.

Our experience of substantially lowering the mortality rate using MATH+ protocols is made all the more remarkable by the fact that our hospital now routinely admits severely ill patients referred by other hospitals and ICUs that for whatever reason are not administering the MATH+ protocol.  These patients, in many cases, are those that the referring hospital/physician has determined will not likely survive.  As our success has become increasingly known among treating physicians in the Houston area, and beyond, those referrals have risen to account for approximately 10-15% of our admitted COVID-19 patients.  While we have been able to cure the vast majority of those  patients using MATH+, in my opinion, the advanced stage of the disease we see in the referred patients likely accounts for some of the increase in our mortality rate for COVID patients.  Nevertheless, we are currently experiencing a mortality rate in our hospitals of just 5%.

DR. KORY: It is my strongly held belief – based on my experience as a clinician for almost twenty years generally, and my real-world experience with the therapeutic protocols at issue here in particular – that the hospital’s prohibition of Dr. Marik’s use of his MATH+ Protocol in treating his patients will not help them, but will in many cases increase their suffering, advance their disease, and result in deaths which could have been avoided had Dr. Marik been permitted to use the Protocol.

Barring Dr. Marik from using the medicines he believes will help his patients recover is unconscionable, contrary to reason and science, and violative of the doctor/patient relationship – a relationship that has been recognized for centuries as one rooted in near sacred trust. It is the attending physician, the doctor at the bedside – the one who knows not only the fullest extent of patient details possible, but who watches and cares for the patient day-to-day, and makes needed adjustments to therapeutic approaches based on improvements and/or deteriorations, and who possesses the knowledge, experience and hands-on involvement that are the keys to the most effective treatment possible – who is ultimately responsible for the patient and who customarily is, and must be, the decisionmaker for and with each patient, having fully informed and consulted with the patient regarding the treatment alternatives.

The role of hospital administrators in such decisions, if they have any role at all, has historically been minimal. The blanket, one-size-fits-all Prohibition involved here is, in my medical opinion, without justification and contrary to good medical practice. Hospital administrators’ judgments should not be substituted for the judgments of experienced attending physicians who have expertise in the relevant areas of medicine and specific knowledge of the particular patients under their care.

DR. VARON: My experience with the success of the MATH+ protocol has been confirmed by fellow FLCCC-physicians and other colleagues around the world. The success is also documented in over 30 randomized controlled trials reporting substantial improvements in a number of important outcomes associated with the various elements of the protocol. Peer-reviewed articles both in journals and on the National Institute of Health website attest to its efficacy And well-documented reports from India, Mexico and some 80 countries around the world show dramatic improvement in the treatment and prevention of COVID using MATH+ protocols (or variations thereof) —-including an early treatment and prevention protocol FLCCC physicians have created and known as I-MASK+.

I wholeheartedly believe that the MATH+ protocol, as administered on an individualized basis by competent physicians, saves lives, and saves them in significant numbers over and above other treatments currently in widespread use, as evidenced by the data.  Moreover, the protocol is extraordinarily safe. In short, there is no reason at all not, at minimum, to fully inform patients of its availability, risks and benefits, and to administer it upon their informed consent.

DR. KORY: It is highly unusual for a hospital or hospital administrators to interfere in or countermand an attending physician’s treatment decisions concerning his or her patients. This kind of intervention was virtually unheard of before COVID. It is my view that such intervention should be undertaken in only the rarest of circumstances, and even then only on the basis of specific and compelling medical reasons relevant to a particular case or situation.

To deny these therapies to patients who are suffering from the dreadful disease of COVID – and who are in many instances facing the prospect of death as a result of the swift progress of that disease if left unchecked – is in my opinion just plain wrong, and is not in accordance with the duty and care owed to our patients.

Pierre Kory M.D., M.P.H.

Dr. Kory graduated with an MD degree from St. George’s University and completed his residency and fellowship training in critical care and pulmonary medicine. In addition, he did clinical rotations at the Weill Cornell School of Medicine. He is board certified in Internal Medicine, Pulmonary Diseases, and Critical Care Medicine. Dr. Kory practiced for seven years at Beth Israel Medical Center in New York City as an ICU and pulmonary outpatient physician. At the University of Wisconsin in Madison, he served as Medical Director of the Trauma and Life Support Center, as the critical care service chief, and was an attending physician in the outpatient pulmonary medical clinic. He is a recognized expert in critical care ultrasonography; and received the British Medical Association’s President’s Choice award for his work in producing the medical textbook Point of Care Ultrasound.

Dr. Paul Marik

Dr. Marik received his medical degree from the University of the Witwatersrand, Johannesburg, South Africa, followed by a Master of Medicine Degree, Bachelor of Science Degree in Pharmacology, Diploma in Anesthesia, as well as a Diploma in Tropical Medicine and Hygiene. Dr. Marik did a Critical Care Fellowship in London, Ontario, Canada, during which time he was admitted as a Fellow to the Royal College of Physicians and Surgeon of Canada. Dr. Marik has worked in various teaching hospitals in the US since 1992. He is board certified in Internal Medicine, Critical Care Medicine, Neurocritical Care and Nutrition Science. Dr. Marik is currently a Professor of Medicine. He has authored over 500 peer reviewed journal articles, 80 book chapters, and four critical care books. He has been cited over 44,000 times in peer-reviewed publications and has an H-index of 98, a score that indicates exceptional productivity and scientific impact. Dr. Marik has delivered over 350 lectures at international conferences and visiting professorships. He has been an invited member of numerous society guideline development committees.

Joseph Varon, M.D., FACP, FCCP, FCCM, FRSM

Dr. Joseph Varon has been practicing medicine continually since 1987 and is Board certified in Internal Medicine, Critical Care Medicine and Pulmonary Disease.  He is the author of 12 textbooks, 15 dozen book chapters and more than 830 peer-reviewed articles on those and other medical subjects. He is the Associate Dean of the Caribbean Medical University and I also holds active professorships in various fields of medicine and surgery in over 12 international medical schools, the Universite Claude Bernard, Lyon, France, and The University of Houston School of Medicine and Baylor College of Medicine, in Houston, Texas.

The hearing on the complaint will be heard on Thursday, November 18, 2021 in the courtroom of Judge David Lannetti in the Circuit Court for the City of Norfolk, Virginia.