A Master Class in Medical Ethics in the age of COVID19 from my 95-year-old Dad
The other day, I was speaking with my father about my work on the Communications and Education team for the Frontline COVID19 Critical Care Alliance (FLCCC). (My dad, Jack Kamen, is a 95-year-old retired Anesthesiology/Critical Care professor and Chief of Intensive Care who spent his career at St. Mary Mercy Medical Center in northwest Indiana and at Northwestern University Hospital in Chicago.) During our conversation at his home, where he still lives independently, I was telling Dad about how months ago, the FLCCC doctors developed an effective hospital treatment protocol called “MATH+” for critically ill COVID19 patients. (MATH+ is Methylprednisolone, Ascorbic Acid, Thiamine, Heparin, plus several additional co-interventions.) I told Dad that in March, the FLCCC doctors urgently reported to health authorities that the protocol was saving lives — if given to patients when they first experience shortness of breath from COVID19. At the time, most hospitals were reporting that their COVID19 mortality rates were anywhere from 30%-75% — with some even higher. But the hospitals of our physicians where MATH+ was being used had a 6% average mortality rate.
Dad was listening intently. I explained to him that neither mainstream medicine nor mainstream media would listen to these super-brilliant physicians, who were urging doctors treating COVID19 patients around the country to immediately adopt the MATH+ protocol to save the tens of thousands of people who were dying. The replies to their pleas pretty much went something like this: “Where are your double-blind randomized controlled trials (RCTs)?” “We need data.” “Your protocol calls for steroids that the World Health Organization (WHO) is strongly recommending against.” “You have ascorbic acid (Vitamin C) in MATH+? Thiamine too? Melatonin? Vitamin D? Zinc? Magnesium? Are you serious?” “Do an RCT and we’ll consider writing the story.”
“Well, they are actually right,” said Dad, who was a long-time reviewer for the medical journal Chest — one of the most prestigious journals in the field. “Double-blind studies is just how medicine works. It has to. In order for something to become widely accepted therapeutic practice, you need to prove your protocol by publishing a peer-reviewed study.”
“But, dad, there ARE several peer reviewed studies that we provided the journalists and other physicians to show that COVID19 is a steroid-responsive disease. Our physicians knew that their MATH+ protocol bucked all the major national and international health care societies that they believed had badly misinterpreted the medical literature. We shared with them that one of our physicians, Dr. G. Umberto Meduri, published the landmark paper which pointed out the errors the societies had made in recommending against the use of corticosteroids, and despite its publication in a journal of the Society of Critical Care Medicine, which then disseminated it to all of its members, there was little change in treatment approaches. And because of that, it is more than likely that thousands of patients who died after becoming critically ill with Covid19 and who were suffering from massive inflammation may have been saved if Methylprednisolone (a safe yet powerful anti-inflammatory medicine) had been provided to them.
“And Dad, another of our physicians, Dr. Paul Marik, worked with all the FLCCC doctors to adapt his groundbreaking 2018 peer-reviewed study on the treatment of sepsis for the treatment of COVID19. His “HAT” therapy (Hydrocortisone, Ascorbic Acid and Thiamine) is the basis of what eventually became MATH+ for critically ill COVID19 patients.
Dad thought for a moment. “Joyce, that’s all fine. But those studies did not specifically examine the MATH+ protocol itself. And that is why you keep hitting brick walls.”
“OK, dad,” I said, wanting desperately to win him over to my side of the argument. “Let me read you something that I wrote to a producer from CNN last week, trying to explain to her why she should interview one of our physicians about MATH+ — even though we did not have the RCT that she really wanted to see.”
Dad listened as I read an excerpt from the email I wrote to that CNN producer:
“…Here were some of the most highly respected and highly published Critical Care doctors in the country…in the midst of a killer pandemic, and they were being asked to randomize some of their patients to supportive care, knowing that if they did, they would be sending those patients to their deaths. That’s essentially why…an RCT has not been published by our group. The Recovery trial [on the use of dexamethasone in COVID19] had to be stopped because the researchers at Oxford quickly learned that the patients they randomized to placebo were dying. But our doctors knew all of this months ago…and wanted to get the word out there to save lives…which is the sole goal of the FLCCC Alliance.”
I reminded Dad that it was only last week that the WHO finally reversed its stance and recommended the use of steroids for COVID19.
Dad looked at me and gave a slight shoulder shrug as if to say, “I already told you what I think.” But I could see he was trying to work it all out in his mind.
So I came at it a different way.
“OK, dad, let’s look at it like this. Say you’re the doctor in your old ICU in Gary, Indiana as a pandemic is raging across the country. You’re giving your critically ill patients the MATH+ protocol because you know from previous studies done on the components and your clinical expertise in the ICU that this cocktail will save their lives. Sure enough, mostly all of your patients recover, while thousands are dying in other hospitals. Now, the doctors in these other hospitals know or have heard about MATH+, but they won’t use it without RCTs. They say the WHO strongly recommends against using steroids. They think Ascorbic Acid and the other natural interventions in the protocol are junk science. So they are giving their patients supportive care instead, but their patients are dying at an alarming rate.
“And so you are told that the only way to convince the world that MATH+ saves lives is to do a double blind study and randomize some of your own critically ill patients to placebo…when you know that if you do, most of those you place on placebo will probably die. Will you agree to do the study?”
He thought for a long moment. Then he spoke. “Yes,” he said. “I would do the study, but not exactly as you describe.”
“WHAT???” I could hardly believe what I was hearing. I had always considered my dad to be the most ethically principled physician in the world.
“Wait,” he said. “Just listen. What I would do, of course, is continue to give all of my patients who required MATH+ the treatment cocktail, just as I had been doing. Then, I would tell the health authorities to compare my institutional clinical data with the clinical data of patients in other hospitals NOT receiving MATH+. The collection of the data would have to meticulously measure apples to apples…considering things like age, gender, co-morbidities, lifestyle, symptoms, length of symptoms, severity of symptoms, full clinical history; with day by day comparisons highlighting medicines used, dosages, days used, and subsequent treatment outcomes and so on. That’s the RCT that can be done. Randomized NOT by the doctors — but by organized medicine within the United States.”
Whoa. Just whoa. Could the randomized clinical trials we’ve been asked to produce already be underway by federal health authorities such as the Centers for Disease Control (CDC), the National Institutes of Health (NIH), the WHO or even the Department of Health and Human Services (HHS) and national health insurance providers who should all have access to this data? If not, why not? (It could not possibly be because the components of MATH+ are off-patent, globally available, safe and inexpensive…right? I mean, I only bring it up because the “treatments” we do hear about are those of large pharmaceutical companies, which are touted about in every national news cycle with minimal data about their efficacy; and oh, by the way, they cost a lot of money…)
I sat back and watched my dad silently staring past me. I sensed he was still thinking about his answer and imagining himself still in the tiny 6-bed ICU he opened in the 1960s (the first in Indiana). Those were his glory days. Working long, long hours…called out as many as three times a night…always learning, reading, teaching, probing, trying anything and everything to save every patient that came through the double doors of his ICU. Of course Dad would not randomize any of his patients to a placebo when he knew he could save them. I knew that.
I was still thinking about the conversation I had with my dad as my husband Fred and I drove home.
“At 95, Dad is still teaching, isn’t he Fred?”
Fred, who is a pulmonologist, replied, “Talking with your dad about medicine is like taking a master class in filmmaking with Stephen Spielberg.”
Dad never wanted to leave that ICU — or medicine — but the vagaries of old age had other plans for him. Thanks for your brilliance and your unfailing humanity, Dad. I’ll get back to you soon about the RCT for MATH+. I feel certain that if you were still fighting today on the frontlines of this pandemic, you’d be COVID19’s most formidable foe. I just know it.