Is SOT for Lyme & Tick-borne Infections a Scam?

Updated: 9/19/23 

This update includes a review of research published by the manufacturer of Lyme SOT in late 2022. Based on my review of this new science, I have retitled this article: Is SOT for Lyme & Tick-borne Infections a Scam?

Probability of Health Improvement

• My clinical experience: not enough experience to say
• MyLymeData: no research conducted
• RGCC Funded Research: biased study with inadequate data
• Placebo effect benefit of any prescription medicine: 30-40 percent

For more information about the best research-supported germ killing approaches to recover from Lyme disease see What Works? Navigating Prescription & Alternative Medicine Lyme Treatments.

Supportive Oligonucleotide Therapy Background

Supportive Oligonucleotide Therapy (SOT) is a new treatment for Lyme disease. SOT is also called Antisense Oligonucleotide Therapy (ASOT), which is the term used in medical research papers. SOT uses laboratory-derived nucleic acids (genetic code) that blocks production of disease-causing proteins or even gene expression. These pieces of genetic code are called oligonucleotides. You can think of oligonucleotides as a genetic message.

For example, in Duchenne muscular dystrophy (DMD), SOT provides oligonucleotides to direct the correct production of a protein called dystrophin. People with muscular dystrophy are born with DNA that provides the wrong genetic message for dystrophin. SOT correction to the DNA message leads to production of dystrophin. This prevents the muscle damage seen in DMD.

In Lyme disease, a currently available type of SOT produced by Research Genetic Cancer Center (RGCC) in Greece uses oligonucleotides to stop germ growth and replication. Unlike the SOT therapy for DMD, the Lyme SOT is not an FDA-approved drug. To be approved by the FDA, a therapy must have scientific evidence of safety and effectiveness.

As I explain below, SOT does not alter DNA. Instead, it provides a short-term change to how the DNA blueprint is expressed.

There are currently nine SOT drugs approved by the FDA or European regulators to treat. They are:

• Batten disease,
• cytomegalovirus retinitis,
• Duchenne muscular dystrophy (DMD),
• familial chylomicronemia syndrome,
• familial hypercholesterolemia,
• hereditary transthyretin-mediated amyloidosis, and
• spinal muscular atrophy.

According to Wikipedia, nearly 50 SOT drugs are in various levels of clinical trials. In my research, I am not able to identify one published laboratory or human trial using SOT for Lyme disease.

Lyme Disease SOT Claims—No Credible Research

In Lyme disease, these oligonucleotides are being used to interrupt and block protein production required for the germ to replicate and grow. In theory, this leads to the death of existing germs and stops the spread of new germs. The clinics currently offering SOT therapy in the U.S. are purchasing non-FDA-approved SOT drugs from RGCC.

In late 2022 RGCC published a paper claiming to show some benefit for SOT. (2) Their study showed decreased DNA copies of Lyme in individuals treated two times. However, the study was highly biased and pre-designed in a way to reach the conclusion that SOT works.  

Here are the major problems with the RGCC paper. 

1. Research Bias. The study was funded and conducted by RGCC who financially benefits by the way they interpret the data and publish the data.
2. There is No Control Group. The research does not include a control group of people given a placebo. Therfore we cannot tell what the placebo effect of benefit is in this study. 
3. PCR-Determined Germ Load in Lyme is Prone to Error. The authors claim their data show after two treatments there are decreased DNA copies of Lyme in those studied. However, they used a PCR method to detect copies of Lyme DNA. It is well known that this method misses Lyme disease 70% of the time when Lyme is present. Quantitative PCR detection of DNA copies in Lyme is not reliable. 
4. Statistical Hocus Pokus. To show positive result, the authors engage in statistical hokus pokus. They should have shared information showing actual decrease germ load for individuals treated so we can evaluate their claim. 
5. Decreased DNA Copies May Not Equal Improved Symptoms. A useful endpoint in a Lyme treatment is that a patient feels better—that their health improves. The authors did not collect or publish health data on those treated. 
6. Very Small Sample Size. We cannot make any generalizations about a treatment working based on a sample size of 28 people.

Besides the RGCC study, there is no other published research on tick-borne infections and SOT. And the RGCC study is terribly flawed. Thus, it is fair to say there is no credible research supporting SOT for Lyme or other tick-borne infections.

Profits over Science

It is worrisome that

• RGCC finally got around to conducting research to see if their therapy works years after they started profiting from their product and
• numerous clinicians are charging excessive amounts for this treatment without any credible scientific research showing that it actually works. 

More About How SOT Works: A Genetic Primer

DNA, RNA, Oligonucleotides

Our genetic code that provides the blueprint to produce proteins in the body is called DNA. The building blocks of DNA are called nucleic acids. There are five different kinds of nucleic acid: adenine, cytosine, guanine, thymine, and uracil. Thymine occurs only in DNA and uracil only in RNA. DNA is made of two strands of nucleic acids wound around each other.

The DNA message and directions for protein production are turned into RNA. RNA is a single strand of nucleic acids. DNA is found in the center of a cell. Once the RNA is made from the DNA, it moves to part of the cell where protein is made. The RNA’s directions are read in a protein production factory in the cell called a ribosome. If the RNA is readable, a specific protein coded by the RNA is made.

Oligonucleotides are short strands of nucleic acids. These strands are much shorter than RNA and DNA. Oligonucleotides are usually made of 15-20 nucleic acids.

How SOT Works

SOT could work in Lyme disease in a variety of ways. Below I discuss three possibilities.

1. One way that SOT works is to provide oligonucleotides that bind to part of the RNA. This prevents the RNA from being read. These are blocking oligonucleotides that bind to a type of RNA called messenger RNA, or mRNA for short.
2. Another way some SOT works is to bind to the mRNA and then cut it up into unreadable pieces.
3. There is also a type of microRNA, called miRNA for short. This type of RNA regulates protein production or even germ replication. One type of SOT can bind the miRNA so it cannot work.

The RNA-SOT complex is eventually broken down in the cell by enzymes and replaced by new RNA. To be clear, SOT oligonucleotides do not change the DNA blueprint for the body or the DNA of germs.

Potential Problems with SOT

Correctly Identifying the Patient’s Infections

As I understand, the SOT treatment by RGCC for each patient is individualized based on testing of the patient’s blood for active infections. The testing technique is to use a PCR method to detect the DNA of the various bacteria, though this is problematic. PCR testing for Lyme infection is well-known to find Lyme only 30 percent of the time. In the case of Bartonella, the germ often does not live in the blood, so trying to detect DNA of Bartonella is often not effective either. Given this issue, I question how RGCC is developing treatments for these two infections that often are not found with PCR testing.

Knowing this issue, in an email to RGCC on April 18, 2022, I asked RGCC to provide validation studies for its PCR testing method. In a validation study, a lab tests its method on samples of blood that have and do not have the infection. They then find out if their test is effective at correctly determining which samples have the infection and which ones do not. RGCC responded that its test technique is certified and valid. However, it did not provide me any information about how the validation studies were performed or data about how effective they were at determining if someone has the infection(s) when present.

Reaching the Inner Cell

Our bodies make enzymes that break down RNA and oligonucleotides. This presents a problem because the oligonucleotides could be destroyed before they even bind to RNA. The pharmaceutical industry has developed various modifications to the sugar backbone of the oligonucleotides to make them resistant to the breakdown enzymes.

SOT oligonucleotides must cross the cell membrane, moving from outside to inside the cell, where they bind to RNA. This presents another problem for SOT. There are different ways the pharmaceutical companies are addressing this problem. For instance, some SOT is wrapped in microscopic layers of fat to increase absorption into the cells.

Safety Issues

Potential safety issues with SOT therapies are a concern. Some SOT therapies investigated by the pharmaceutical industry have been shown to accumulate in organs like the kidney, liver, and spleen, causing injury and toxicity.

Reaching Every Germ and Every Germ Type

SOT for Lyme needs to target each type of infection that is part of the person’s Lyme disease. This presents two problems. First, an SOT therapy should target Lyme germs and other infections, if present, like Bartonella and Babesia. Second, regarding Lyme, the germ hides away

• inside cells,
• in tissues with poor blood flow like tendons and scar tissue, and
• deep within biofilm communities.

Therefore, it is very doubtful one infusion of SOT will reach all germs where they hide.

Furthermore, Lyme and Bartonella germs can exist in non-growing persister forms. SOT is designed to block growth and replication. However, persisters are not growing, they are hibernating. So, it is very unlikely SOT could kill persister forms. For more information about Lyme persisters and persister treatments, see How to Treat Persister Lyme. What Works?

RGCC, SOT Clinics, and Regulation

I suspect the FDA will eventually shut down centers providing Lyme SOT that is not FDA-approved. My interpretation of FDA guidance suggests SOT oligonucleotides qualify as a drug. Drugs are subject to FDA regulation; the FDA only allows for the sale and use of approved drugs. Lyme SOT provided by RGCC is not an FDA-approved drug.

Does Lyme Disease SOT Work?

I am not sure if current SOT for Lyme disease or coinfections works. As I discuss previously, there are several obstacles for effective Lyme SOT. Given the barriers of SOT reaching every Lyme germ and likely not having activity against persister Lyme, I am doubtful SOT is an effective therapy for most people. I have seen a small number of patients in my clinic who have tried this therapy before seeing me with minimal-to-no-effect. Some of my physician colleagues who offer this therapy claim some patients have improved.

The Benefits Could Be a Placebo Effect

Keep in mind that the average drug in clinical trials has a placebo effect of 30-40 percent. This means 30-40 percent of people in clinical trials improve by taking an inert pill without an active ingredient—a so-called sugar pill. So, if some claim benefit from SOT, it may have nothing to do with the oligonucleotides of SOT; the benefits could be a placebo effect.

Collective Experience Matters

Many therapies physicians offer in Lyme disease have limited science or studies showing they work. As a result, the fact that Lyme SOT does not currently have any studies supporting its use does not stop me from considering its use. However, even though many Lyme therapies have limited science, healthcare providers share knowledge based on our experiences about whether a therapy works. When research is lacking, we can learn what may work for Lyme based on our collective shared experiences. For SOT, there currently is not enough collective experience among patients, physicians, or other healthcare providers showing if SOT is effective.

The Future of SOT

SOT therapies hold great promise for a variety of illnesses. It is possible a pharmaceutical company will find a way to address each of the concerns about safety and delivery I raise above. If it is developed correctly, Lyme SOT could change the face of Lyme disease treatment and improve patient outcomes.

I look forward to seeing research in this area as it evolves.

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