The Drug That Cracked COVID (Part 1)
From This Buffalo Hospital Room, a Grandmother Led the Global Fight for the Drug That Could Save Her Life and End the Pandemic
On the morning of December 18, 2020, as the newscaster announced a grim New York record for COVID-19 deaths and the weatherman predicted a white Christmas for Buffalo, Judy Smentkiewicz drove home from a house cleaning job, excited about the holiday. But her back hurt bad, and she was unusually exhausted. “I thought it was my age, being eighty years old, working every day,” she said. “I never thought about COVID.”
Judy’s small house in Cheektowaga, just east of Buffalo, was all set for Christmas. Daughter Michelle, who lives a few miles away and talks to her mother five times a day, put up the tree and the decorations and the snowman on the front lawn of grandma’s house with her daughter until it looked like a scene from It’s a Wonderful Life. Son Michael came up from Florida with his wife Haley to help his sister cook the family Christmas Eve dinner, usually for twenty-five, but now just immediate family with “COVID shaping everything,” Michael said. Michael, fifty-seven, hasn’t lived in Buffalo for close to thirty years, and relishes the trip home.
But now he was worried. Mom was sleeping twelve hours a day. She couldn’t eat. She couldn’t lift the phone. “I’m fine, I’m just tired,” she kept saying. But Judy was always up with the sun. After raising two children as a single mother, working thirty-five years as an office manager for Metropolitan Life Insurance Company, she was still cleaning houses five mornings a week with her girlfriends to “keep busy.” On December 22, three days before Christmas, Judy tested positive for COVID-19.
“We were devastated,” Michael said. The family Christmas Eve dinner was cancelled, Judy spent Christmas in quarantine in her house, four days after Christmas she was taken by ambulance to Millard Fillmore Suburban Hospital, and on New Year’s Eve Michael and Michelle got a call from the hospital that their mother was being admitted to the ICU. It all happened so fast. “We can’t be with her,” Michael said. “We can’t hold her hand, we can’t sleep in the room with her.” He started keeping notes to make sense of it all. “Hearing her voice crack on the phone as she agreed to go on the ventilator was HEART-BREAKING,” he wrote.
His mother was sedated and unresponsive, as if she were in a coma, as a ventilator mechanically breathed for her. The doctors said there was little more they could do, and her chances of survival were bleak. Judy was getting the global standard of COVID-19 care recommended by the World Health Organization, the National Institutes of Health, and all major public health agencies. It was called “supportive care.” Judy was told to stay at home since there was nothing the doctor could do for her anyway, it was best to keep patients away from doctors and everyone else, until she had trouble breathing in week two. That was the sign the disease had entered its potentially fatal stage and it was time to go to the hospital where doctors couldn’t do much but more supportive care. In other words, Judy would have to save herself.
“Hearing her voice crack on the phone as she agreed to go on the ventilator was HEART-BREAKING,” he wrote.
“There is no antiviral drug proven to be effective against the virus,” The New York Times said on March 17, 2020, under the headline “Hundreds of Scientists Scramble to Find a Coronavirus Treatment.” It was day seven of the pandemic, when the global death toll was 7,138. “When people get infected,” the Times said, “the best that doctors can offer is supportive care—the patient is getting enough oxygen, managing fever and using a ventilator to push air into the lungs, if needed—to give the immune system time to fight the infection.” The global death toll was more than 3.3 million as this story went to press, and scientists are still scrambling. The NIH and WHO are still recommending Tylenol and water in 2021. There is still no approved treatment for all stages of COVID-19.
Even with the rollout of vaccines, they are “not the whole answer,” Dr. Francis Collins, director of the NIH, said recently on 60 Minutes, with variants that threaten to defeat vaccines in rich countries constantly sweeping the Earth after mutating in that majority of poor 7.9 billion humans who won’t get a big pharma jab any time soon. According to The Wall Street Journal, global deaths in 2021 will soon exceed 2020, and millions more are expected to die. “People are going to continue to get sick,” Collins said. “We need treatments for those people.”
Michael was calling the doctors and nurses constantly, but “we heard nothing but bad, bad news. Mom wasn’t getting any better. It’s going to be a long haul, she’s in bad shape, prepare yourself.” The doctors and nurses said they had exhausted all treatment options, and like so many others Judy was highly likely to die. When an eighty-year-old COVID-19 patient goes on a ventilator, they said, it’s a highly likely death sentence—eighty percent of them don’t survive. The prolonged critical illness was typically about a month with little or no change until, surrounded by helpless doctors and nurses and goodbyes and cries of loved ones echoing from a Zoom call, they turned blue and suffocated to death.
But as Judy lay dying in the small hospital eight miles northeast of Buffalo, almost six hundred miles south in Norfolk, Virginia, Dr. Paul Marik, sixty-three, the endowed professor at the Eastern Virginia Medical School and a world-renowned clinician-researcher, was unknowingly preparing to save her life with a “wonder drug” that obliterates COVID-19. Discovering the drug was one thing, but getting it to Judy’s doctors in time to save her, getting it to the many thousands of people who needed it, would be a harrowing journey to rival the Iditarod mushers’ 1925 serum run of 675 miles through ice and snow to Nome, Alaska so Dr. Curtis Welch could stop the diphtheria epidemic. But this “Great Race of Mercy” had far less chance of success, for the obstacles were not in nature but in the minds and hearts of other men.
Marik was accustomed to beating the odds. The legendary professor, a 6-foot, 230-pound, balding, barrel-chested, bear of a man with a crisp native South African accent touched with the South after thirty years, is the second most published critical care doctor in the history of medicine, with more than 500 peer-reviewed papers and books, 43,000 scholarly citations of his work, and a research “H” rating higher than many Nobel Prize winners. Marik is world famous as creator of the “Marik Cocktail,” a revolutionary cocktail of cheap, safe, generic, FDA-approved drugs that dramatically reduces death rates from sepsis by 20 to 50 percent anywhere in the world—whether you’re in a hospital in Zurich or Zimbabwe, Chicago or Chengdu—down to near zero, when given soon after presentation to hospitals.
Since he published what he calls the “HAT Therapy” (Hydrocortisone, Ascorbic Acid [intravenous Vitamin C] and Thiamine) in 2016 in the most prestigious peer-reviewed journal in the field, Marik has received worldwide publicity, is celebrated in James Bond Internet memes with the “Marik Cocktail” shaken, not stirred, and is seen in ICUs around the globe as a historic figure in medicine for improving care of sepsis, which last year passed cancer and heart disease as the world’s number one killer, according to Lancet. Marik, known as a quirky genius and an exceptionally kind-hearted doctor (his most published peer in the annals of medicine doesn't see patients), has been searching for an effective treatment for COVID-19 since it began.
Now, while Judy’s doctors were stumped, he was spending long days and nights at the Sentara Norfolk General Hospital, a large, 563-bed teaching hospital on the EVMS campus, where Marik, head of pulmonology and critical care, was treating hundreds of critically ill COVID-19 patients, many referred to him from all over the 1.8-million population Hampton Roads region.
The pandemic had pushed him to nights doing Zoom grand rounds and making YouTube videos instructing doctors and hospitals all over the world on treating COVID-19, sending out a daily EVMS COVID-19 Management Protocol online for doctors worldwide, and hunting the literature for the “wonder drug” that would save Judy Smentkiewicz and bring the pandemic to an end.
This was not something many people thought possible. But while the world was living the nightmare of the COVID-19 pandemic like a Michael Crichton sci-fi horror production where the planet is facing a plague apocalypse, millions die, and doctors can do nothing as brilliant pharmaceutical scientists race to develop vaccines to save the globe in the final scene, Paul Marik had a different movie in his head. He was startled and appalled that all the national and international public health agencies recommended that the most well-trained, well-equipped doctors in history stand down and wait on big pharma’s lab scientists while the worst pandemic in a century devastated the world. “It’s therapeutic nihilism to say that doctors can do nothing,” Marik said. “Supportive care is no care at all.” What Marik did was assemble four of his closest friends, whoalso happen to be four of the top academic critical care doctors in the world. He challenged them to join him in an expert panel to continually review the literature while treating their COVID-19 patients and developing treatment protocols—low-cost generic therapies that countless black and brown and poor people all over the world would need, he saw from the beginning, or face a coming catastrophe without treatments or vaccines.
“It’s therapeutic nihilism to say that doctors can do nothing,” Dr. Marik said. “Supportive care is no care at all.”
These five doctors set out to save the world, with a better chance at it than most. Pulmonary critical care specialists often lead medical teams at hospitals in a crisis. “Lungs are the most common organ that fails in the ICU and in the context of many diseases,” says Dr. Pierre Kory, Marik’s protégé. “Pulmonary critical care physicians (are)…the most widely skilled, and the most knowledgeable and experienced in all facets of disease and all levels of severity to the extent that no other doctor comes close.” ICUs were getting hammered by the new respiratory plague all around the world, but Marik had assembled a group of intensivists with nearly 2,000 peer-reviewed papers and books and over a century of bedside experience in treating multi-organ failure and severe pneumonia-type diseases. If anyone could arrest the coronavirus in a living patient, they could.
Marik turned to his dearest colleague in medicine in Houston, professor and doctor Joseph Varon, a Mexican American with academic appointments in both his countries that have included the University of Texas Health Science Center, and research innovations including a cooling cryo-helmet he used to save his own life when he had a stroke. He then recruited his comrade-in-arms in sepsis therapies, the renowned Dr. Gianfranco Umberto Meduri, an Italian, professor at the University of Tennessee Health Science Center in Memphis, the father of noninvasive intubation and world authority on steroid treatment of ARDS (Acute Respiratory Distress Syndrome) and COVID-19. He called on his longtime boon colleague and former resident Dr. Jose Iglesias, from Cuba, a highly published associate professor of medicine at Hackensack Meridian School of Medicine in Seton Hall, New Jersey, and director of one of that state’s largest dialysis centers. At age fifty, the youngest of the group was Pierre Kory, a big, passionate doctor-scientist like Marik, and his protégé. Kory was a highly published former associate professor and critical care service chief at the University of Wisconsin-Madison and the director of the Trauma and Life Support Center at University Hospital, one of the top academic medical centers in the world. If you go by the traditional measure of lives saved by research breakthroughs or bedside care, Marik, Meduri, Varon, Iglesias, and Kory—four brilliant immigrants from South Africa, Italy, Mexico, Cuba, and one brash New Yorker—are the finest COVID-19 clinician-researchers of the pandemic.
They made their first major breakthrough in March 2020, by the third week of the pandemic when only 3,800 Americans had died. It was based on the idea that COVID-19 has one great weakness: the coronavirus doesn't kill anybody. In a mechanism so diabolical Marik believes “human beings aren’t smart enough to have figured it out,” the trillions upon trillions of coronaviruses that overwhelm and sicken the host don’t kill it. But in the second week of the disease, all the coronaviruses die, and like suicide bombers flooding out of a Trojan Horse swamp the body with a “vast viral graveyard” that triggers a friendly-fire hyper-immune response that in turn unleashes monstrous multi-organ inflammation and clotting like doctors have never seen. A body dying of COVID-19 is a complex, terrifying sight. But its weakness is simple: “As pulmonary critical care doctors we know how to treat inflammation and clotting, with corticosteroids and anticoagulants,” Marik says. “It’s first-grade science.”
From the beginning of the pandemic, the hospitals that Marik and Varon led had COVID-19 beat. They achieved remarkably high survival rates at their hospitals at a time when 40 to 80 percent of patients in the U.S. and Europe were dying from the disease. Their success was achieved with the group’s now-famous MATH+ protocol for hospitalized COVID-19 patients.
The cocktail of safe, cheap, FDA-approved generic drugs—the steroid Methylprednisolone, Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and the blood thinner Heparin—was the first comprehensive treatment using aggressive corticosteroid and anti-coagulant treatments to stop COVID-19 deaths. Both were novel approaches strongly recommended against by all national and international health care agencies throughout the world, but later studies made both therapies the global standard of hospital care. In addition, Kory, Marik, et. al published the first comprehensive COVID-19 prevention and early treatment protocol (which they would eventually call I-MASK). It is centered around the drug ivermectin, which President Trump used at Walter Reed hospital, unreported by the press, though it may well have saved the president’s life while he was instead touting new big pharma drugs.
The doctors published their breakthroughs in real time on the website of their nonprofit research group, the Front Line COVID-19 Critical Care Alliance (www.flccc.net ), so doctors anywhere in the world could find them and use them immediately. Marik, Kory, Varon, Meduri, and Iglesias became heroes of the pandemic to intensivists around the globe who used their protocols to save thousands of lives, and to practitioners at many hospitals in the U.S., including the St. Francis Medical Center in Trenton, New Jersey, where Dr. Eric Osgood posted the MATH+ protocol on a private Facebook group for thousands of ICU doctors after it stopped the dying in his hospital, and talked it up with his colleagues around the nation. Marik and his colleagues receive more than five hundred emails a day from doctors and patients begging for help to beat COVID-19, and they answer all of them, comforting patients and their families, coaching other doctors, and saving lives. Emails like this (unedited):
Dear Dr Marik I am from a remote place(Muzaffarpur,Bihar) in India.people are not that rich and can’t effort costly treatment.i used your MATH PLUS protocol in TOTO to save hundreds of life at very low cost.since there is limited govt facility I have managed pts with SPO2 of even 72% at room air with home oxygen,proning and MATH PLUS.I don’t have words to thank you for this.you deserve to get Nobel Prize for your protocol.Words are not supporting me enough to thank you. Dr Vimohan Kumar
If anyone could arrest the coronavirus in a living patient, they could.
Many prominent doctors and scientists around the world believe that Marik, Kory, Meduri, Varon, and Iglesias deserve the Nobel Prize in medicine. Dr. Keith Berkowitz, director of the Center for Balanced Health on Madison Avenue in New York City and Dr. Robert Atkins’ former medical director, and Dr. Howard Kornfeld, founder of the Recovery Without Walls Clinic in Marin County, California, found Marik while looking in the literature for COVID-19 treatments for their patients, and convinced him to form the nonprofit FLCCC to get the word out to the world and save humanity.
Emmy Award-winning publicist Joyce Kamen of Cincinnati and former CBS News correspondent Betsy Ashton of New York City set aside their lives and began working tirelessly to reach every famous TV newsperson, scientist, and public health expert you know and hundreds you don’t, the handful of science writers who have won Pulitzer Prizes, the five thousand science writers on a special news wire who haven’t, every science desk from CNN to NBC News to the Atlantic magazine, every governor and member of Congress, President Trump, Dr. Anthony Fauci, and, when the time came, President-Elect Biden. Nobody responded.
Marik thought it might be a good idea if doctors who were actually saving lives with treatments that could save almost everybody could spend a few minutes on the podium sharing their knowledge with the world after Trump made his speeches and Fauci and Dr. Deborah Birx talked about flattening the curve and obeying lockdowns so millions wouldn’t die. “People are dying needlessly,” Marik said. “We’ve cracked the code of the coronavirus.” Nobody seemed to care.
Kory even testified to the Senate on May 6, 2020, his first appearance before the committee seeking COVID-19 treatments, that steroids were “critical” to saving lives and received silence and scorn. Six weeks later, the publication of the Oxford University Recovery Trial proved that the FLCCC doctors were right, and corticosteroids became the accepted worldwide standard of care, changing the trajectory of the pandemic. Now, millions of deaths later, steroids remain “the only therapy considered “proven” as a life-saving treatment in COVID-19,” he says, and only in “patients with moderate to severe illness.”
No approved treatment to stop the sick from getting sicker and overloading hospitals, where they face possible death, yet exists. All the non-vaccine big pharma designer treatments for COVID-19 have largely failed to show an impact on mortality, Kory says, including Remdesivir and monoclonal antibody therapy. The Holy Grail COVID-19 treatment remains elusive. On November 11, 2020, Dr. Fauci co-authored a paper for JAMA: The Journal of the American Medical Association, “Therapy for Early COVID-19, A Critical Need,” explaining that early treatments “to prevent disease progression and longer-term complications are urgently needed.”
A month earlier, Dr. Marik had found exactly what Dr. Fauci was seeking. The discovery astounded him.
In the professor’s continual review of “the latest (and best) literature,” he picked up a surprising “data signal” in October from emerging studies in Latin America. ivermectin, a safe, cheap, FDA-approved anti-parasitic drug, was showing remarkable anti-viral and anti-inflammatory activity as a repurposed drug—the most powerful COVID-19 killer known to science.
Marik had been keeping tabs on ivermectin but hadn’t included it in his protocols. He knew the drug as a core medicine on the WHO Model List of Essential Medicines, and it is well-established in the literature as a “wonder drug” that won the 2015 Nobel Prize for its discoverer, Japanese microbiologist Satoshi Ōmura, for nearly eradicating two of the “most disfiguring and devastating diseases” in history, river blindness and elephantiasis, that had plagued millions of people in Africa countries, one of the great achievements in the history of medicine. The drug was also well known as a standard treatment for scabies and lice, from nurseries to nursing homes. A veterinary version keeps millions of family dogs and cats, farm animals, and cattle safe from worms and parasitic diseases. An over-the-counter medicine in France, ivermectin is safer than Tylenol and “one of the safest drugs ever given to humanity,” Dr. Marik said, with “3.7 billion doses administered in forty years, that’s B for billion, and only extremely rare serious side effects.”
An earlier Australian study, reported in the journal Antiviral Research, showed that ivermectin, which blocked other RNA viruses like Dengue virus, yellow fever virus, Zika virus, West Nile virus, influenza, the Avian flu, and HIV1/AIDS in vitro, decimated the coronavirus in vitro, wiping out “essentially all viral material by 48 hours.” But more research was needed in human beings.
But by October Marik’s concerns were answered. The studies were well-designed university trials that showed amazing anti-COVID-19 activity at the normal doses used to treat parasites. Though small and endlessly diverse by large, Western big pharma “one-size-fits all” random control trials, the ivermectin studies were a mosaic of hundreds of scientists and many thousands of patients in trials all over the world, all showing the same remarkable efficacy against all phases of COVID-19 no matter what dose or age or severity of the patient. “Penicillin never was randomized,” Marik says. “It just obviously worked. Ivermectin obviously works.”
Marik was astonished. “If you were to say, tell me the characteristics of a perfect drug to treat COVID-19, what would you ask for?” he said. “I think you would ask firstly for something that’s safe, that’s cheap, that’s readily available, and has anti-viral and anti-inflammatory properties. People would say, “That’s ridiculous. There could not possibly be a drug that has all of those characteristics. That’s just unreasonable. But we do have such a drug. The drug is called ivermectin.”
If it were universally distributed at a dose that costs ten American cents in India and about the cost of a Big Mac in the United States, he said, ivermectin would save countless lives, crush variants, eliminate the need for endless big pharma booster shots, and end the pandemic all over the world.
There were no effective, lifesaving, approved COVID-19 treatments that doctors had used to slow down or stop the coronavirus in the history of the pandemic, in any phase of the disease, except the one, corticosteroids, that Marik and company had discovered.
Now they had discovered another treatment, even more powerful, that could save the world.
Surely, Marik thought, the world would listen this time.