Band of Brothers

Part I in a series on Dr. Paul Marik—a magnificent doctor who was fired from his job and professorship because he successfully treated his COVID-19 patients with FDA-approved drugs and high-dose Vitamin C.

Author’s Note: The following post is from The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex, by John Leake and Peter A. McCullough. MD, MPH.

Dr. Paul Marik is to critical care medicine what Dr. McCullough is to cardio-renal medicine. The 65-year-old native of South Africa has published over 500 peer-reviewed papers and books, which made him the second most published critical care doctor in the history of medicine.

Upon meeting Dr. Marik, one is overwhelmed by the impression of his vast physical stature. His gentle manners and elegant South African accent conjure accounts of 19th century British gentleman explorers. Since the early days of his career, he’d been keenly interested in discovering how to treat sepsis—the body’s extreme, life-threatening response to an infection. Well into the 21st century, sepsis continued to be a major cause of death. According to the CDC, approximately 1.7 million American adults fall ill with sepsis every year, of which approximately 270,000 die in hospital. Globally, the sepsis burden is estimated at 15 to 19 million cases annually, with a mortality rate approaching 60% in low-income countries.

Dr. Marik knew the literature on sepsis treatment. Several studies had indicated that large doses of IV-administered Vitamin C and Vitamin B1 (thiamine) showed some benefit. Other studies indicated that hydrocortisone showed promise. Dr. Marik reasoned that combining the three into a cocktail could amplify their benefit. As had often been observed in medicine, combining agents seems to affect multiple pathways, causing an overlapping and synergistic effect.

In 2016, he and his colleagues conducted a study in which they compared 47 sepsis patients who received the cocktail to a control group of 47 patients who received sepsis standard of care at the time. The mortality rate of the treatment group was 8.5% compared to 40.4% of the control group—a stunning difference. Skeptics claimed the study was too small and nonrandomized. Nevertheless, what became known as the “Marik Cocktail” was adopted by critical care units all over the world, which reported excellent results with the therapy.

When COVID-19 struck and Dr. Marik’s critical care unit at the Sentara Norfolk General Hospital received its first patients, he observed they were suffering from an inflammatory lung reaction, and he suspected this could be treated with a corticosteroid. He contacted four other critical care specialists—Professor Joseph Varon at United Memorial Medical Center in Houston (who, in the year 2020, would work 268 days straight treating COVID-19 patients in his ICU) Professor Gianfranco Umberto Meduri at the University of Tennessee Health Science Center in Memphis, Professor Jose Iglesias at the Hackensack Meridian School of Medicine in Seton Hall, New Jersey, and Professor Pierre Kory at the University of Wisconsin-Madison. As author Michael Capuzzo pointed out in his marvelous story about these doctors, it would be hard to imagine a more experienced and scholarly team of pulmonary critical care doctors.

Together they formed the Frontline COVID-19 Critical Care Consortium (FLCCC) and got to work on a protocol for saving hospitalized patients. They started their work by focusing on the extreme inflammation they were observing. Often called “cytokine storm” after the proteins produced by the immune system, this was an extreme and maladaptive immune response that had often been observed in other viral illnesses, including virulent influenza. It was this inflammation of the lungs, kidneys, and other organs that killed the patient, and not the virus itself. Thus, the key to treating the syndrome was reducing this inflammation.

Professor Meduri was a leading expert on corticosteroid therapy in critical illness. He conducted an exhaustive review of corticosteroid use against SARS-CoV-1, MERS, and H1N1 and found significant evidence that these agents had been lifesaving in their reduction of extreme inflammation. For decades the corticosteroid methylprednisolone had been the standard medication for suppressing cytokine storm. And yet, despite this glaring fact, every US federal health agency recommended against using corticosteroids against COVID-19 from the outset of the pandemic.

Unlike these agencies, the FLCCC concluded that their best bet for tackling the disease in hospitalized patients was a combination of Methylprednisolone and the antioxidant Ascorbic acid (Vitamin C). To these they added Thiamine (Vitamin B1) to optimize cellular oxygen utilization and energy consumption, and the anticoagulant Heparin to prevent and help in dissolving blood clots that appear with high frequency.

There is nothing experimental about these drugs. Methylprednisolone and heparin had long been FDA-approved for treating inflammation and blood clotting. Vitamin C and B1 were available over the counter, though in the hospital setting they were IV-administered in high doses. The FLCCC doctors began giving this “MATH Protocol” to ICU patients and tracked their progress for a case study. By the end of April, they had treated 100. Of these, 98 survived. The two who died were in their eighties and had other advanced chronic illnesses. None of the patients had long durations on ventilators, were ventilator dependent, and or had long hospital stays.

During this period, Dr. Pierre Kory was in daily communication with ICU doctors in his native New York City, where he’d worked in multiple hospitals. His colleagues reported that they turned the tide in the ICUs as soon as they started using methylprednisolone. Other ICU doctors in hard hit New Orleans reported the same. Kory and colleagues therefore sent letters to the White House, the CDC, and the NIH, presenting their real-world evidence of the corticosteroid’s efficacy—all to no avail.

Dr. Kory’s efforts were drawn to the attention of Wisconsin Senator Ron Johnson, who was chairman of the Senate Homeland Security Committee. Since his daughter had been born with a congenital heart defect—successfully corrected by an innovative operation—Senator Johnson had believed that if citizens were faced with a life-threatening condition for which there was no proven treatment, they should have the right to try drugs or operations that seem to offer some benefit, even if these had not yet passed the conventional FDA-approval process. The alternative was to do nothing and accept the high probability of death.

Critics of the right to try claim that unless procedures and medications are carefully regulated by the FDA, unscrupulous doctors will create false hope by offering them to desperate patients, even if there is little trial data to prove their efficacy. Senator Johnson did not find this argument persuasive and he introduced his federal right to try bill in 2017. A companion bill was introduced in the House, ultimately passed in both houses, and was signed into law by President Trump in 2018.

Upon Senator Johnson’s invitation, Professor Kory addressed the Senate Homeland Security Committee on May 6, 2020. Speaking via WebEx, Kory stated the credentials of the FLCCC doctors, and then explained the rationale for using their protocol. He then reported the success they and other doctors were having with it. This was excellent news, and a naive viewer would likely assume that it would be welcomed by the entire medical profession.

And yet, despite the FLCCC’s well-founded rationale for their therapy, broad consensus for the efficacy of its components in related conditions, and their success with it, they continued to get pushback from the CDC and NIH, which refused to change their advisory against using corticosteroids to treat COVID-19. On four occasions, the FLCCC tried to notify the White House of their favorable results, but they received no reply.

Reposted from the author’s Substack