Carnitine: An FDA Approved Natural Substance Therapy for Children Shows Promise for Patients with Pulmonary Hypertension (A Patient History Following the Moderna booster shot)

(A Patient History Following the Moderna Covid booster shot)
Stephen L. DeFelice, M.D.

It all began in late 2021 after Patricia Anne Connell, the woman whom I love, received the Moderna Covid vaccine  booster shot. What followed were chronic devastating, painful  attacks on her multiple body systems so much so that she, over a year and a half later, has been, with the exception of periodic short stays at home, hospitalized or in a physical therapy facility. Three times her medical team strongly recommended to her the Hospice option  which I would not permit simply because there were promising options. Because of her extremely complicated case, I was by her side every day, making sure that she received the proper care. Only her powerful will to live allowed her to endure such persistent physically painful and mental suffering.

After consultation with a few old-time experienced physician colleagues as well as untold hours on the internet, I made the diagnosis of a pan-autoimmune response to the vaccine where antibodies, in addition to attacking the Covid virus, also attacked and damaged multiple organ systems causing extensive systemic inflammation.  

Though she experienced a wide variety of clinical symptoms, her three main diagnoses are a) Central nervous system involvement accompanied by mental confusion coupled with extremely painful peripheral neuropathies  b) kidney failure, and she now requires renal dialysis and c) life- threatening pulmonary hypertension. It was the latter that caused me to discover the clinical effectiveness of carnitine for this disease.

The main cause of death of this condition is cardiac failure of the right ventricle of the heart. Deoxygenated blood from the veins returns to the right ventricle to be pumped through the pulmonary artery to deliver the blood to the lungs in order to be re-oxygenated. When, for some reason, the pulmonary artery becomes narrow or constricted, the right ventricle must work harder to pump the blood through the artery to reach the lungs. This disease is called pulmonary hypertension. Over time, the right ventricle becomes enlarged and weakened causing irreversible heart failure and death. It’s a disease that’s tough to treat where standard heart drugs are not very effective.

Now to carnitine: As a young doctor, I brought carnitine into the United States and conducted its first clinical trial where I discovered that it might protect the heart in patients with angina pectoris or myocardial ischemia due to blocked coronary arteries which leads to a lack of oxygen supply to the heart cells. Over the years, I guided it through our complicated regulatory system, and it was finally approved by the FDA for the rare and fatal disease in children, Primary Carnitine Deficiency, where death is due to heart failure. It’s a genetic disease which prevents carnitine from transporting fatty acids across mitochondrial membranes of the heart to produce energy. Though the causes are different, the biological effect, i.e., lack of transport of fatty acids across mitochondrial membranes, is exactly what occurs in myocardial ischemia.

How does carnitine work? The heart uses fatty acids instead of sugar or glucose as its main source of energy. The reason is that the heart is a high energy requiring organ and requires fat or fatty acids as its primary fuel because fats have twice as much energy as sugar per molecule. Carnitine transports fatty acids into the mitochondria, the furnaces of the heart cells, where it is metabolized to produce energy or ATP.  When myocardial ischemia occurs, carnitine leaks out of the cells and the heart turns to sugar for energy, which is a poor energy source for the heart. As a result of myocardial ischemia, heart arrythmias,  heart attacks and heart failure follow.  A clinical study in patients with myocardial ischemia demonstrated that the stressed  ischemic heart loses carnitine confirming laboratory findings. 

There are a number of laboratory and clinical published studies demonstrating that carnitine either prevents or reverses myocardial ischemia including in patients with chronic heart failure where the administration of intravenous carnitine significantly improved cardiac function. Also, the patients could walk greater distances particularly in those with higher blood carnitine levels. 

I, along with distinguished and dynamic cardiovascular pharmacologist, Major James Vick, conducted the initial carnitine laboratory studies at WRAIR, the Walter Reed Army Institute of Research, which confirmed and expanded carnitine’s cardiovascular activity. For example, In addition to its anti-ischemic properties, we discovered that carnitine blocks the fatal septic shock caused by the bacterium, E. coli., a fatal disease in hospitalized patients and the cardiotoxicity of Adriamycin, a powerful anti-cancer drug.  I then participated in the first clinical study led by cardiologist James Thomsen, at the University of Wisconsin in patients with coronary heart disease which confirmed carnitine’s anti-ischemic effect. It was published in the distinguished journal, the American Journal of Cardiology.

After Patricia’s diagnosis of pulmonary hypertension was made, the first  thought that jumped to mind was that her entire heart, both right and left, was weakened due to myocardial ischemia – carnitine deficiency combination. Her right ventricle was both enlarged and in heart failure because of her partially blocked pulmonary artery was not pumping enough blood to the lung to be oxygenated which the heart itself needed.  Because of her weakened heart, her lungs were beginning to be filled with fluid and being partially collapsed dramatically reducing the availability of lung tissue to be oxygenated, and her legs were substantially edematous or swollen. 

I tried to contact her expert cardiologists, pulmonologists and nephrologists at the hospital regarding her desperate need for carnitine, but I found it difficult to contact them which taught me how the new health system puts pressure on doctors to see a certain number of patients, a kind of quota system. No doubt the system is superb regarding uncomplicated cases, but for complicated ones, such as Patricia’s, it requires time to learn about it. In addition, carnitine is not well known which adds to the complexity of her case. Also, post Covid vaccine adverse effects had not yet been reported in the literature.

Over the years, I followed the carnitine clinical and scientific publications quite closely and hadn’t come across a single article regarding carnitine and pulmonary hypertension. But, to make sure,  I  gave it a try.  And, Wow!, I could have kicked myself in the ass for my delay. I leapt for joy to discover that there are laboratory and clinical studies which unequivocally support the promise of carnitine’s clinical effectiveness in the treatment of pulmonary hypertension. In laboratory studies carnitine improved right sided heart function and increased the metabolism of fatty acids. A clinical study with high dose intravenous carnitine (5 grams) administered  for only seven days significantly improved WHO class cardiac function, elevated blood pressures and improved short- term exercise. I was disappointed that the study didn’t last more than 7 days.

Then it happened. Patricia finally entered the end- stage of heart failure. Her lungs were both more filled with fluid and partially collapsed, her legs swollen, and she was markedly short of breath even though high volume oxygen was being administered intranasally. Her doctor advised her to immediately prepare for Hospice. I ruled against it and, let’s say “passionately” insisted that the doctor  with authority to give that order that she immediately receive intravenous carnitine at the doses reported in the clinical studies. I also emphasized that it is an extremely safe natural substance supported by the FDA package insert. Evidently, I convinced someone with authority for suddenly an intern or resident appeared who told me he was responsible for administering carnitine to Patricia.  He, after reading my carnitine information, decided on a dose that was much too low to be effective. After very heated discussions, he agreed on the higher dose which was immediately administered during that day. For the record, he prescribed a creative dosing schedule which impressed me.

I told Patricia the “good news”, and while her body was saturated with multiple catheters placed  in multiple blood vessels along with that constant nasal oxygenator going full force, she still had enough energy to manage her beautiful smile. Boy, that smile sent me to the local Catholic Church where I made a deal with God. He, for the record, drove a hard bargain.

The next morning, as I was about to leave for the hospital, the phone rang, and it was from Patricia. I held my breath for I didn’t know if it would be bad news, good news, or no news. Her first joy-laden  words were, “Steve, I really feel much, much better. Your carnitine worked.” Her clinical response was unequivocally dramatic and the lilt in her voice confirmed it.

Despite her long battle with her other multiple disease states, Patricia’s cardiac status continued to improve with carnitine though there was no definitive carnitine-administration program.  I, however,  did manage to make it constantly available to her either orally or intravenously with the help of   sympathetic doctors and wonderful nurses. Interestingly enough, I guided the entire dosage regimen. 

But let’s get back to the Moderna booster shot when her journey of multiple disease states almost immediately  began— and continues. The following is a short list of  the events that transpired: a) four Emergency Squad visits at my home where the first one brought her to the hospital Emergency Unit due acute onset of mental confusion which was diagnosed as a possible stroke b) Emergency Squad visit at the dialysis center where I personally along with the staff observed Patricia suddenly turn lobster-red accompanied by significant mental confusion which was initially  diagnosed as possible stroke in the hospital, but, instead, was due to profound hypoglycemia or low blood sugar which was so low that it could not be measured. The doctors had never seen such a case  c) extremely painful  small fiber neuropathy  of both legs where she could not stand and had to be gently lifted by the Squad personnel to be placed in the ambulance c)  two major falls due to her general weakness with head injuries.

 She also experienced a) periodic auditory and visual hallucinations b) visual acuity problems c) significant loss of hearing d) probable Capillary Leak Syndrome with swollen extremely painful areas of the legs with heavily weeping skin lesions which required lengthy treatments at a wound center and e) and the visceral obesity syndrome where substantial amounts of fat accumulates on the body organs under the belly giving the impression that it is ascites or abdominal fluid. There are other events such as periodic chills and nausea and large amounts of nasal mucous causing strenuous bouts of coughing and regurgitation of food.

Not too long ago Patricia experienced what appeared to be another untreatable fatal condition. She required renal dialysis to survive, but her blood pressure during the procedure became so low that it would be fatal if they continued. A group of health personnel including a kidney doctor along with Patricia’s son, James, and I met in her room to prepare her for their Hospice presentation. She was very weak and weary in the initial stages of fatal renal failure being  inclined to accept her rendezvous with death. But James and I surprisingly and  independently came up with a therapeutic solution where the medications would be administered differently to avoid the severe hypotension. He delivered a persuasive presentation to the doubting group and Patricia, with renewed hope and energy, agreed to try the new approach. It worked superbly during the first and subsequent dialysis sessions up to this day.  

It’s been over 18 months since whatever is the actual single cause of her general devastating body attacks began, and there is a rational hope that it may be coming to an end. If it was due to a general antibody response to the Moderna booster-her Covid tests were consistently negative- perhaps the antibodies, as they do with the Covid virus antibodies themselves, are fading away. For the record, there is no other known disease that could be the etiology or cause of all that she experienced.

But the good news is that Patricia’s travails  may have led to the discovery of carnitine as a lifesaving natural safe substance for patients with life-threatening pulmonary hypertension. Clinical studies are certainly indicated. If designed properly, they can be brief and definitive. But in the meantime, doctors should consider carnitine as an option in treating existing patients.

The other good news is that her general condition has stabilized, and she is now at my home undergoing physical therapy in order to learn to walk again-and doing well! And she is now being treated by highly competent  physicians who have time to care for her. Included in this group is a superb cardiologist who both understands carnitine and how the heart uniquely behaves in patients with pulmonary hypertension.