If someone you loved — a family member, a friend, a colleague, a classmate, or someone you admired — died from complications of Covid19, then what I am about to tell you will (rightly) make you angry.
It is quite possible that your “someone” did not have to die.
Truth. Here’s WHAT you need to know. But WHY you need to know this is just as important.
Before Covid19 landed upon American shores and began to spread rapidly throughout the country — a small group of highly published, leading Critical Care physician-scholars began collaborating about the treatment protocols that should be given to patients entering the hyper-inflammatory phase of the disease. (The phase that kills.) Their goal, of course, was to save as many people as possible.
Dr. G. Umberto Meduri, a member of the group (which was soon named “The Frontline Covid19 Critical Care Working Group” (FLCCC) ) is the world’s expert on corticosteroids in Acute Respiratory Distress Syndrome (ARDS) and critical illness. He is the first author on multiple placebo controlled Randomized Controlled Trials (RCT) on corticosteroids — which have shown mortality benefits in a variety of conditions. Dr. Meduri, along with several expert colleagues, published a paper in the Society of Critical Care Medicine publication a few months ago. It was disseminated to its immense international membership and showed that after analyzing data from the prior pandemics, they found that corticosteroids were life-saving. This was in direct contradiction to the recommendations of the World Health Organization, (WHO) the Centers for Disease Control (CDC), the American College of Chest Physicians (ACCP) and other allied medical organizations. The paper showed that in over 7,000 patients from the two largest trials of corticosteroids in SARS/MERS/H1N1, steroids demonstrated dramatic mortality benefits in anyone beyond mild illness (i.e. almost all patients in the hospital).
Here’s what that means and why it is important: To the FLCCC — but NOT to the WHO/CDC/ACCP — the use of steroids in a protocol to control hyper-inflammation was already a proven FACT. So when members of the FLCCC reached out to alert health authorities about the treatment protocol they developed and why they knew it would help save lives, no one would listen. No one. (The protocol also included Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1) and Heparin, components of the “HAT” protocol for sepsis pioneered and published by Dr. Paul Marik, another FLCCC physician and the second most highly impactful published intensivist in the world.)
The doors that were slammed shut in the face of the pleadings of the Critical Care physicians of the FLCCC remained impenetrable because the protocol, called “MATH+” (Methylprednisolone, Ascorbic Acid, Thiamine and Heparin, plus several additional co-interventions) had not yet been proven with an RCT. So the healthcare authorities were, in essence, telling the FLCCC that in order for them to be taken seriously, they must randomize patients entering the critical phase of Covid19 to a group who did not get a corticosteroid.
The FLCCC physicians were stunned — and desperately (and repeatedly) tried to communicate to health authorities (and several media outlets) that asking for an RCT in the midst of a pandemic was highly unethical. They were in the business of saving their patients — not knowingly sending them off to what they believed would be a grim fate. They pointed to the long-standing Article 37 of the Helsinki articles stipulating the ethics of conducting medical research:
HELSINKI ARTICLE 37: “Unproven Interventions in Clinical Practice”
“In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy.
So here, the entire country was facing a pandemic; and would very soon have patients who were going to be flooding American hospitals with severe illness from Covid19. These patients had highly elevated chances of dying and the FLCCC had a therapy at hand. Their experience and deep knowledge of the existing medical literature told them that their protocol had the very strong likelihood of benefiting/saving these patients. They explained to authorities that their decades of experience in treating ARDS in the ICU with repeated mortality benefits were the result not only of the original investigations; but also from the more recent, and definitive DEXA-ARDS trial published in February in Lancet which was a large, prospective, double blind, multi-center RCT. It showed enormous mortality benefits and other positive patient-centered outcomes with corticosteroids in ARDS.
The FLCCC doctors also discovered that their MATH+ Protocol needed to be started much earlier in the disease course. The onset of the critical phase of Covid19 (when a patient becomes short of breath) was, in their opinion, a “hospitalist’s” disease and not an “intensivist’s” disease, because the time for intervention was BEFORE the patient needed to enter the ICU. MATH+ is not designed for the ICU — but for the hospitalized patient EARLY in the course.
And still — there was silence.
The MATH+ Protocol was walked over to the White House by emissaries on four separate occasions, only to be met with silence and inaction. In Congressional testimony on May 6, 2020 before the Senate Committee on Homeland Security and Governmental Affairs, FLCCC physician Dr. Pierre Kory testified to senators that in such a case as the Covid19 pandemic, research is always secondary to saving lives. And they WERE saving lives. Lots of them.
And then yesterday came the news that the physicians of the FLCCC had known for months: Researchers at Oxford University in England reported a common steroid drug as a “breakthrough” treatment — dexamethasone — for the most severe cases of coronavirus — based on findings from a large, randomized controlled trial in the U.K. The FLCCC was extremely pleased at the professed results of the “RECOVERY” trial because it will have worldwide impacts. The physicians involved in that trial, unlike the FLCCC, had “true clinical equipoise” (an assumption that there was not a ‘better’ intervention present). It is likely that they held the opinion of the WHO/CDC — that steroids were just as likely to be harmful (based on their interpretation of prior pandemic literature) as they were helpful (based on supportive ARDS literature). But the Oxford researchers ended their trial early due to “excess deaths in the control group” — those not receiving steroids. This is undeniable evidence as to why the FLCCC would never have agreed to conduct such an RCT. They knew it would harm the control group. This report now essentially mandates that placebo controlled RCT’s on corticosteroids in Covid-19 should never be done again.
The new study notwithstanding, the FLCCC says that larger and more dramatic impacts on survival can be achieved with the drug and dosing strategy incorporated into MATH+ — rather than the dexamethasone that was the focus of the trial steroid. FLCCC physicians say that Methylprednisolone in the MATH+ protocol reaches higher concentrations in lung tissue; and the recommended dose has been shown to be the most highly effective dose based on prior pandemics and ARDS trials.
Throughout the last several months — as the death toll from the pandemic continued to rise — the physicians of the FLCCC persisted with their pleas to the media and health authorities to let the world know that their protocol could save countless lives. All along, they worked in ICUs — and used MATH+ in their ERs and in the wards. What can be reported now about MATH+ is this: At FLCCC physician Dr. Joseph Varon’s hospital in Houston, Texas, there was a reported a 1% hospital mortality rate among over 100 patients admitted. And in Dr. Marik’s Norfolk, Virginia hospital, there has been a 7% hospital mortality in over 100 Covid19 patients admitted. (Manuscripts under preparation). Contrast this with the 25–26% reported in New York hospitals so far. But for patients who end up on ventilators in the ICU, the mortality rate is MUCH higher — between 30% and 70% — or more. And that’s the urgency the FLCCC physicians have over this media and mainstream medicine blackout: If MATH+ can be started in the Emergency Room within 6 hours of a patient’s arrival, the ICU and the need for mechanical ventilation can most always be avoided.
So, if mainstream media, mainstream medicine and elected officials (with whom they also pleaded) had just listened to the FLCCC physicians, it is quite possible (even probable) that thousands upon thousands of Americans who died from the ravages of Covid19 would be home with their families right now.
The news in that new study, which had mainstream medicine, the mainstream media, elected officials and seemingly the whole world jumping for joy yesterday, was the very same news that was given to health officials and the news media months ago by the FLCCC doctors — some of the most greatly respected and eminently published leaders and scholars in the field of Critical Care medicine.
And people had to die unnecessarily because these courageous physicians could not, under any circumstance, obey the edict from the Ivory Towers that they conduct RCTs, which would have forced them to send some of their patients off to die in an unethical drug trial when they knew they could save most all of them.
So you see, perhaps your “someone” did not have to die.
I am angry as hell.