Jon D. Kaiser, MD, has been treating patients with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome), HIV/AIDS, cancer and other immune system disorders for more than 25 years. He is a Clinical Associate at the San Francisco Medical School and previous Medical Director of K-PAX Pharmaceuticals.
Dr. Kaiser has written two books on improving immune system health, Immune Power and Healing HIV, and has given many lectures on optimizing immune function. He was also the principle investigator of a study published in the Journal of AIDS in 2006 showing that broad-spectrum micronutrient therapy can strengthen the immune systems of people with immune deficiency disorders.
His proof-of-concept study investigating a mitochondrial support strategy for patients with chronic fatigue syndrome was published in the International Journal of Clinical and Experimental Medicine in 2015.
Dr. Kaiser’s approach to care utilizes an integration of natural and standard medical treatments.
An Interview with Jon D. Kaiser, MD
ProHealth (PH): How did you get involved with ME/CFS?
Dr. Kaiser: After several grueling years of medical training and working in emergency rooms, my health started to fail. Within a one-year period, I developed full-blown CFS. The disease caused me to quit working in emergency medicine and open up a private practice where I could set my own hours, with enough time to rest in-between patients. That change allowed me to begin working toward finding a way out of this devastating disease.
With a combination of rest, pacing, micronutrient therapy, physical therapy, plus an aggressive stress-reduction program, I began to climb out of “the dark pit” that is ME/CFS. It took five years to get to a place where I was no longer tired and in pain the majority of the time. However, for many years I experienced relatively severe relapses that often lasted from days to weeks.
Currently, after many years of doing everything I could to support my health, I feel that my ME/CFS condition is in remission. However, I know that there is always a chance that it might recur if I don’t stay focused on caring for my health.
During this time I also began caring for people with ME/CFS. Over the past twenty years I have cared for several hundred patients with this illness. I’m pleased to say that I’ve seen many patients improve and even completely recover from this disease.
PH: What do you feel is the central mechanism driving ME/CFS symptoms?
Dr. Kaiser: Many CFS researchers are working hard to answer this question. There have been clearly demonstrated abnormalities in the nervous, immune, and endocrine systems. There is also a subgroup of patients who exhibit significant GI (gastrointestinal) symptoms. The focus of my recent work has been on identifying and describing mitochondrial abnormalities in patients with ME/CFS.
One of the main criteria for a “mitochondrial disease” is that patients exhibit symptoms spanning multiple bodily systems (domains). This is clearly the case with ME/CFS as it affects the nervous, endocrine, immune, muscular, and GI systems. In addition, imaging studies have identified a deficiency of glutathione in the brains of patients with this disease. Glutathione is a key antioxidant required for healthy mitochondrial functioning.
The treatment I have been developing supplies a precursor to glutathione (N-acetyl-cysteine), as well as many other important mitochondrial nutrients, to support healthy brain function and energy metabolism. I believe this avenue of investigation can ultimately help provide improvement in fatigue symptoms, as well as alertness and concentration difficulties, in patients with ME/CFS.
PH: How did you become interested in treating mitochondrial dysfunction and ultimately develop the K-PAX formula?
Dr. Kaiser: At the beginning of the AIDS epidemic, several of the early antiviral drugs were shown to directly cause toxicity to the mitochondria ultimately leading to fatigue, immune dysfunction, dementia, and many other serious side effects. My primary goal in developing the K-PAX micronutrient formula was to identify an antidote to this horrible toxicity to the mitochondria of my AIDS patients.
With initial funding from the pharmaceutical giant Bristol-Myers Squibb, I was able to demonstrate extremely positive effects of this mitochondrial support nutrient formula on the nervous and immune systems of AIDS patients who were experiencing mitochondrial toxicity. The results of this double-blind, placebo-controlled trial were published in the Journal of AIDS in 2006.
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When Bristol-Myers Squibb elected not to continue supporting the development of an inexpensive, natural product that could protect patients from their drug’s side effects, K-PAX Pharmaceuticals was founded in order to continue its development.
Once research on mitochondrial dysfunction in ME/CFS patients began to be published, I decided to shift my focus from working with AIDS patients to helping people with ME/CFS.
PH: What is the K-PAX formula? And how does it work?
Dr. Kaiser: The K-PAX formula contains a key combination of micronutrients that, based on research and clinical experience, helps to improve the health and energy production of the body’s mitochondria. This key combination includes nutrients that are not often found in your average multivitamin but are critically important to optimal mitochondrial functioning.
For example, acetyl-L-carnitine, which is present in food, helps to naturally stimulate the mitochondria to generate energy from fat molecules. Since fat molecules possess twice the energy generating capacity per gram as sugar molecules, supplementing with this nutrient can stimulate the mitochondrial to generate more energy. However, a key point is that when the mitochondria are stimulated in this fashion, they can also create more oxidative stress compounds (such as hydrogen peroxide). Therefore, in order to keep the reaction healthy and balanced, one needs to counter this increased oxidative stress with potent antioxidants such as alpha lipoic acid and N-acetyl-cysteine.
The dosages of most of the key ingredients in this formula are administered at pharmacologic dosages. This means that they are not being supplemented to treat vitamin deficiencies but instead are being delivered at levels designed to produce a positive physiologic effect in their own right.
Since there is a growing body of evidence that people with ME/CFS have some degree of mitochondrial dysfunction, providing them with a potent and clinically-tested mitochondrial support supplement makes a good deal of sense. Furthermore, our recently published proof-of-concept study showed that, when this particular supplement is simultaneously taken with a low dosage stimulant drug, a significant decrease in CFS symptoms can occur
PH: Have you tested the K-PAX formula on ME/CFS patients? If so, what was the result?
Dr. Kaiser: This mitochondrial support supplement (plus a low dose stimulant) has been tested in three different groups of ME/CFS patients. The initial testing was performed in my clinic. Upon seeing patients who had been at a plateau with their ME/CFS symptoms for many years experience rapid improvement in a matter of a few months, I felt there was ample reason to move it into clinical trials.
The second group of patients was those studied in the recently published proof-of-concept study. This was a prospective study, meaning that patients who had never taken this treatment before were provided it as a single intervention.
After 12-weeks on treatment, 87% of the study patients experienced at least a 25% reduction in both overall CFS symptoms and concentration difficulties. The treatment was also very well tolerated.
The third group of patients to receive this treatment were those in a recently completed double-blind, placebo controlled trial known as the Synergy Trial. The patients who got the treatment experienced an almost 20% reduction in their overall CFS symptoms. The treatment was also well tolerated in this study.
One of the most interesting findings in this trial was that the group of patients with the most severe symptoms at the beginning of the trial had the most impressive response. While there was also a strong positive response in the placebo group, we feel that the results of this trial provide very important information about things like safety, dosage, and study design that justify moving forward with performing an even larger study of this treatment.
PH: When will the K-PAX formula be made available to the public?
Dr. Kaiser: The K-PAX mitochondrial support formula that was used in the recently published journal article is currently available as “K-PAX Immune Formula.” It contains all of the micronutrients necessary for optimal mitochondrial functioning, including acetyl-L-carnitine, alpha lipoic acid, N-acetyl-cysteine, B-vitamins, and many others. It now also contains coenzyme Q-10 and methyl-folate. It is manufactured using pharmaceutical-grade raw materials and adheres to strict quality control practices.
It is envisioned that a single pill containing the proper ratio of stimulant drug with mitochondrial support nutrients will be submitted to the FDA for approval. This can only occur when a sufficient number of clinical trials are performed substantiating it as safe and effective for the treatment of ME/CFS. This is our ultimate goal.
ProHealth wishes to extend a thank you to Dr. Kaiser for his time and dedication to the ME/CFS community.
This article was first published on ProHealth.com on October 1, 2015 and was updated on February 25, 2021.