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| Dr. Kornfeld hosts the first Zoom meeting |
This is the story about how the FLCCC Alliance was formed—and how, at the start of the pandemic, the team quickly began to develop protocols to successfully treat patients. Their first protocol was the MATH+ Hospital Treatment Protocol that was used to save critically ill patients and to prevent them from having to rely on ventilators to breathe.
Subsequently, as COVID-19 cases surged, they urgently researched ways to offload the hospitals and reduce case counts and deaths. The team developed the I-MASK+ Prevention & Early Outpatient Treatment Protocol—centered around the drug ivermectin—which is effective for every phase of COVID-19 disease… from prevention through late phase illness.
The following is a brief history of how the FLCCC Alliance came together during the time that the Coronavirus Pandemic was rapidly spreading from China and Europe to the United States in early 2020. It is also the story of how things have evolved for us and for the recognition of the MATH+ protocol to date.
For the scientific background of our work we refer to the sections MATH+ Protocol and our scientific rationale MATH+ protocol for the treatment of SARS-CoV-2 infection.
December, 2019. COVID-19, an illness characterized by pneumonia associated with the new coronavirus SARS-CoV-2 (COVID-19), emerges in Wuhan, China.
January, 2020. Dr. Paul E. Marik, Professor of Medicine and Chief of the Division of Pulmonary and Critical Care Medicine at the Eastern Virginia Medical School in Norfolk, Virginia, creates a COVID-19 hospital treatment protocol for the medical school. Called the EVMS protocol, it is based on Dr. Marik’s safe, effective treatment protocol for sepsis — the famous “Marik Cocktail” of intravenous Hydrocortisone, Ascorbic Acid, and Thiamine (HAT).
- CITRIS-ALI, a large double-blind placebo controlled trial of high dose ascorbic acid (AA) in Acute Respiratory Distress Syndrome (ARDS) found that mortality decreased and ICU length-of-stay were markedly reduced in the treatment group.
- The reasons for the lack of immediate adoption of this therapy in ARDS can only be explained by the fact that the original primary outcome analysis failed to account for all the early excess deaths in the control group, where no Sequential Organ Failure Assessment (SOFA) score was assigned to the patients who died. A subsequent letter to the editor demanded an analysis accounting for the early deaths. The study authors complied, and reported the primary outcome of SOFA score to be statistically significantly decreased at 96 hours. Thus CITRIS-ALI, although inexplicably initially portrayed as a negative trial, was later found to be profoundly positive in terms of achieving its primary outcome and important secondary outcomes.
January/February, 2020. Dr. Marik discusses the EVMS protocol with Dr. Pierre Kory, then Associate Professor of Medicine and Chief of Pulmonary and Critical Care at the University of Wisconsin School of Medicine & Public Health in Madison, Wisconsin. Dr. Kory shares his interest in the research and treatment of intravenous AA in septic shock and ARDS with the hopes of finding a reduced need for fluids, vasopressor support, and intubation in COVID patients. Their discussions lead to a decision on a more aggressive dosing strategy for both AA and anticoagulation, to optimally counteract the hyper-inflammation and hyper-coagulability they and others have seen at the bedside and from the COVID outbreaks in China and Italy. The decision on anti-coagulation type and dosing is also heavily influenced by early investigations done using sophisticated clotting assays by Dr. Kory and his group of seasoned critical care doctors and expert hematologists.
March 13, 2020. The United States declares a national emergency in response to the pandemic. New York City becomes the first major “hot spot” in the country, where 20% of hospitalized cases develop acute respiratory failure (ARF) requiring ICU admission. Based on the assumption that COVID-19 represents a viral pneumonia and no anti-coronaviral therapy exists, nearly all national and international health care societies advocate a primary focus on supportive care, avoiding therapies outside of randomized controlled trials, with specific recommendations to avoid the use of corticosteroids. This recommendation stands in opposition to the EVMS protocol which includes hydrocortisone. Inexplicably high mortality rates are reported, with frequent prolonged durations of mechanical ventilation (MV), even from centers expert in supportive care strategies.
March 16–21, 2020. New York City internist Keith Berkowitz searches for a way to treat his patients who contract COVID. He finds the EVMS protocol and calls Dr. Marik, who suggests he also talk to Dr. Kory. Convinced of the benefits of intravenous AA, Dr. Berkowitz wants to get word of the new treatment protocol to government officials and the media. He calls his longtime patient, former CBS News Correspondent Betsy Ashton, for advice. Newly locked down in New York City, Betsy is eager to help him reach out to major media in an effort to potentially save thousands of lives. Dr. Berkowitz urges Drs. Marik and Kory to recruit more critical-care experts to the cause.
March 22–28, 2020. Dr. Howard Kornfeld, a board-certified emergency medicine specialist best known for his Recovery Without Walls pain control clinic in Mill Valley, California, also independently researches and finds the EVMS protocol. He contacts Dr. Marik. Dr. Kornfeld is certain that the protocol, with its enormous potential for saving lives, needs to reach governors and the media. He contacts writer Joyce Kamen, who heads the Kamen Creative Public Relations firm in Cincinnati, Ohio. Kamen’s husband, Dr. Fred Wagshul, is a Pulmonologist and Medical Director of the Lung Center of America, and is also a clinical instructor at the Wright State University School of Medicine in Dayton, Ohio. Both Joyce Kamen and Dr. Wagshul join to help spread the word of the highly promising protocol. Dr. Marik invites Dr. G. Umberto Meduri, Professor of Medicine, Div. of Pulmonary, Critical Care and Sleep Medicine, at the University of Tennessee Health Science Center in Memphis, Tennessee; Dr. Joseph Varon, Chief of Staff & Chief of Critical Care at United Memorial Medical Center in Houston, Texas; and Dr. José Iglesias, Associate Professor of Medicine, Hackensack Meridien School of Medicine at Seton Hall, Department of Nephrology & Critical Care, Community Medical Center, Department of Nephrology, Jersey Shore University Medical Center, Neptune, New Jersey, to join the group. All three, like himself, are leading ascorbic acid experts and are eager to help Dr. Marik create an effective treatment for the challenging new disease that threatens millions around the globe.
March 31, 2020. Betsy Ashton writes the first press release about the new treatment entitled “Hospitals use IV’s of Vitamin C and other low-cost, readily available drugs to cut the death rate for COVID-19 and the need for ventilators.” She reports that Dr. Paul Marik has treated four seriously ill COVID patients, including an 86-year old man suffering heart disease, who was admitted to the hospital on 100% oxygen — a patient not likely to survive. All four survived. Dr. Joe Varon’s sixteen COVID patients had gotten off ventilators in 24 hours instead of 10–21 days. Joyce Kamen pens and publishes a similar article on medium.com the next day.
April 5, 2020. Dr. Kornfeld hosts the first Zoom meeting (see photo), allowing all eight doctors, plus the two media experts, to meet each other and plot the best way to get word of the safe, inexpensive, readily available, and seemingly effective treatment out to the world. The five critical care experts begin sharing many papers a day on a multitude of pathophysiologic and therapeutic topics, while also regularly discussing clinical insights and experiences with their wide network of intensivist colleagues from New York, Italy, and even China. Many deliberations over drugs and dosages follow, deciding whether to use all or limit some of the components in the EVMS protocol, and particularly focus on which corticosteroid to use. Dr. Meduri’s expertise in and rationale for the use of methylprednisolone wins the steroid argument. Needing a name for their group, they decide to call themselves the Front Line Covid-19 Critical Care Consortium.
April 6, 2020. Betsy Ashton writes, and Joyce Kamen designs, the first press releases of the newly formed FLCCC group. The releases urge immediate adoption of the early intervention protocol to reduce the need for ventilators and prevent mortality from COVID-19 disease. They report that Dr. Paul Marik has treated seven seriously ill COVID patients in his Norfolk, Virginia, hospital, and Dr. Joe Varon has treated twenty-four at United Memorial Medical Center in Houston, Texas. Both doctors used the new formula and all patients survived. Joyce Kamen then sets up Facebook and Twitter accounts for the group and posts the releases online. Dr. Keith Berkowitz, through one of a large circle of high-profile contacts, sends the protocol to the White House COVID-19 response team headed at the time by Jared Kushner. This would be the first of four instances where high profile members of the medical, political, and media community would send the protocol to the White House for consideration.
Mid-April, 2020. Throughout April, the doctors read and share studies, modify the dosages, and care for more patients. Dr. Kornfeld sets up the covid19criticalcare.com website for the group hosted by Malik Soomar of webconsuls.com. Joyce Kamen interviews and edits videos of the doctors talking about the new protocol for the website, and for social media platforms. During the group’s second Zoom meeting, Joyce talks about the benefits of naming the protocol with an easy to remember acronym. During that meeting, Fred Wagshul scribbles out the names of the key medicines (see photo), and MATH+ is born — the letters standing for components Methylprednisolone, Ascorbic acid, Thiamin, and Heparin, with the “+” indicating a few other medicines, such as melatonin, zinc, and vitamin D3 to be added based on the high safety, low cost, and emerging scientific data suggesting efficacy.
April 24, 2020. A press release announcing the MATH+ treatment formula is sent out under the new group name of FLCCC Working Group after they are advised that they are too loosely organized to be a “consortium.”
May, 2020. May starts with Dr. Kory testifying on MATH+ as a lead witness before the U.S. Senate Homeland Security & Governmental Affairs Committee. Two new physicians, Dr. Eivind Vinjevoll, Senior Consultant Anesthesiologist, Intensive Care, Emergency Medicine, & Anesthesia, of Volda, Norway; and Dr. Scott Mitchell, Associate Specialist, Emergency Department, Princess Elizabeth Hospital, States of Guernsey, Great Britain, are invited to join as Clinical Advisors to the core group. Media begin discovering the doctors, especially Drs. Kory and Varon. Dr. Varon allows reporters to film inside the COVID unit of his Houston hospital. As a result, many local Houston media, as well as the Los Angeles Times film there. Amanda Hurdelbrink joins to help Joyce keep up with the dozens of comments received daily on social media.
June, 2020. A post-Memorial Day weekend surge of COVID cases floods Texas hospitals, and media from all over the world film in Dr. Varon’s United Memorial Medical Center in Houston. Sky News, the BBC, and CNN all film there and interview him, although the focus of most reports is on the surge of cases rather than the MATH+ treatment protocol he uses. The head of the New York Cancer Resource Alliance hears about the group and offers to help spread word of the MATH+ treatment protocol to the many physicians who support their alliance. Berlin communication designer Frank Benno Junghanns (raumfisch.de/sign) reaches out to and joins the group with his proposals to improve the outreach of the MATH+ Protocol. He proposes this be done by translating it into the most common languages, by revising the corporate design and the website in order to appeal more directly to the medical community, and later with the idea of creating a broader basis for the dissemination of the MATH+ Protocol by reforming the “Working Group” into an “Alliance.” Translations of the MATH+ protocol are posted on the website in six languages and FLCCC doctors are invited and give online talks explaining the protocol to doctors in India, Bolivia, and Argentina.
July–September, 2020. Tens of thousands of people view FLCCC’s posts on social media, and many ask where they can they go for COVID treatment to be assured of getting the MATH+ protocol. In view of the need to respond and grow, FLCCC changes the name of the group to “FLCCC Alliance” and invites other doctors and hospitals who use the protocol to join. Those who use all, or even part, of the MATH+ protocol are urged to join the growing FLCCC Alliance and in August their names are posted on the newly redesigned website. An extensive scientific review of the pathophysiologic and clinical evidence supporting the use of each medicine in MATH+ is added to the website, written over the preceding months by Drs. Kory, Meduri, Iglesias, Varon and Marik.
FLCCC Alliance doctors continue to have a remarkably low — less than 6.1% — rate of mortality after treating nearly 450 patients with MATH+ within six hours of presentation to their hospitals. Those few that don’t survive, the doctors report, either succumb to co-morbidities or had presented in an advanced stage — waited too long before seeking treatment at a hospital.
Throughout these months, the medical establishment and many science writers and editors refuse to acknowledge the group’s collective expertise, rationale, and early treatment success. They refuse to report information about the protocol, demanding instead that the results must first be reported within a randomized controlled trial. Meanwhile, several accomplished educators take notice. Dr. Mobeen Syed, better known as “Dr. Been” to one million medical professionals and students in 182 countries who follow his instructional videos on Facebook and YouTube, uploads four separate videos on the MATH+ treatment protocol. New York Times bestselling author Michael Capuzzo, who is currently writing on a book about the work of our group, recently asked Dr. Syed if he thought MATH+ was the best COVID treatment at this moment? Dr. Syed replied:
“I believe that MATH+ with an aggressive early intervention is the most comprehensive and the best choice available to the medical community… MATH+ is the most important core management approach to save thousands of lives. Not only that, it lends itself to be extended based on individual patient’s body habitus, co-morbidities, etc. If it was up to me, I will (sic) make MATH+ a mandatory protocol for COVID-19 management.”
Asked by Capuzzo what he thinks of the apparent refusal of medical and media authorities to take MATH+ seriously because it has not reached the “gold standard” of a randomized controlled trial, Dr. Syed stated that
“It is true that the community is looking for RCTs, so that desire has […] kept MATH+ at bay. I also think that the people with the interest in earning from this situation will not allow protocols that are simple, inexpensive, and obvious to get enough visibility. Companies that are trying to position their orphan drugs as silver bullets and build their brands take more media time. These companies have more resources to propagate their message compared to a small group.
A majority of the doctors are also not keen on trying anything outside of the guidelines given by health authorities. The issue is that health authorities are also mired with political stancing. I agree that the virus is a new strain, however, the management approaches are tried and tested for decades and MATH+ should be backed at all levels.”
October, 2020. President Donald Trump and much of his White House staff contract COVID-19 a few days after he holds a large gathering at the White House to announce his nominee for Associate Justice on the U.S. Supreme Court. The President gets three days of experimental treatment with monoclonal antibodies and remdesivir along with supplemental oxygen at Walter Reed National Military Medical Center. He also receives several of the medicines in the MATH+ treatment protocol. He recovers quickly, however the media focuses almost solely on the two newer drugs — they never mention the vitamins or zinc from the MATH+ protocol. They continue to ignore the FLCCC Alliance team’s notices about continued success with MATH+ in their Houston and Norfolk hospitals, despite rising case loads and mortality rates from COVID-19 across the country, especially in the Upper Midwest and Mountain states where Trump resumes campaigning in front of large crowds of people not wearing masks or social distancing. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases warns of a catastrophic “second wave” of COVID cases due to hit in the colder winter months if people refuse to wear masks and keep at least six feet apart.
On a more positive note, the Internal Revenue Service grants the FLCCC Alliance 501(c)(3) nonprofit status for the charitable purpose of educating medical professionals and the public in safe and effective ways to prevent and treat COVID-19. This enables the doctors, who continually donate their time and expertise to the cause, to raise money through donations to cover the ongoing costs of the small team of web designers, writer/editors, and social media experts needed to keep the website, social media sites, and lists of scientific studies and new alliance members updated, fact-checked, and put before medical authorities, governments, and world media. Unfortunately, those powers continue to ignore news of our team’s continued success in treating hospitalized patients with the MATH+ treatment protocol. Dr. Pierre Kory and the team of core physicians work many hours on an expanded scientific review of COVID-19 and MATH+, which has now been accepted for publication in the Journal of Intensive Care Medicine.
Meanwhile, Dr. Paul Marik informs the group of many new studies showing ivermectin (IVM) to be a safe, effective, and inexpensive antiviral and anti-inflammatory drug that could be given once a week with zinc + vitamin C + vitamin D to provide prophylactic protection from SARS-CoV-2. Three RCTs favor its use against the virus. Dr. Marik claims ivermectin plus wearing masks may protect better than a vaccine. Available without prescriptions for veterinary use, ivermectin costs only $13/dose for humans by prescription. Off-patent, Merck provides ivermectin free to many poor countries to fight parasitic diseases. The group then performs a comprehensive review of the published and posted clinical trial evidence in support of ivermectin and, after extensive discussion, reaches a consensus to develop a prophylaxis and early treatment protocol centered around the potent drug ivermectin. This becomes the new I-MASK+ prophylaxis and at-home treatment protocol for COVID-19 which, given the evidence showing a drastic reduction in transmission of the virus with use, promises to avoid future lockdowns!
To be continued…
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