What are supportive oligonucleotide therapies? A doctor questions their actual effectiveness

Supportive oligonucleotide therapy (SOT) clinics are springing up across the country. They promise benefits for conditions notoriously difficult to treat, such as Lyme disease and some cancers. As usual, a surge in media attention is fueling the trend and obscuring the truth.

SOT does not have FDA approval, nor is there data to validate the clinics’ claims.

It should be noted that oligonucleotide therapies have FDA approval for the treatment of some conditions, such as Duchenne’s muscular dystrophy, spinal muscular atrophy, and some rare diseases. They earned FDA approval through the efforts of many scientists using rigorous research methods, compiling data that demonstrated the treatments’ effectiveness.

What is SOT?

Oligonucleotides are short strands of DNA and RNA that can affect gene expression. They work by manipulating the production of proteins in disease-causing cells, causing cell death. Among the oligonucleotides approved by the FDA are two that are used most often: antisense oligonucleotide (ASO) and short, interfering RNA (siRNA).

What are the claims about SOT?

Forum Health is one “brand” of clinics offering SOT. The clinic has a YouTube video in which a physician claims, “it’s almost magical.” The video goes on to purport that SOT kills viruses, bacteria, and Lyme disease organisms.

There are only two research papers on SOT in PubMed, a kind of clearinghouse for journal articles, reports, and research results that can be trusted. It isn’t foolproof, however. Both papers describing the use of SOT were generated by a team of Greek scientists whose research was supported by the company that manufactures and distributes most of the oligonucleotides used in the world for SOT. There is an obvious potential conflict of interest, although the authors deny having a conflict of interest.

According to the video, patients first have blood drawn. The specimen is sent to the Greek manufacturer’s lab, where the individual’s ailment is determined. The lab then prepares the SOT to target genes involved in the replication and expression of the diseased genetic material. The individualized SOT is administered intravenously.

The physician narrating the video says, “The overall effects can be astonishing.” She cites a case in which a man with Parkinson’s disease was able to play his violin for the first time in six years.

SOT is usually well-tolerated, but like any treatment, it can have side-effects. Some of the common side-effects include headaches, fatigue, and flu-like symptoms such as body aches, mild fever, and malaise. These side effects typically resolve within 24 to 48 hours.

Clayton Bell, MD, who works at a Forum Health clinic, has received 10 infusions of SOT for symptoms of tickborne bacterial infection. He said the treatment helped him.

Bell says he understands skepticism about the value of SOT because there are no rigorous double-blind, placebo-controlled trials. He also explains that FDA approval is not required because the product is regulated as human cells and tissue (like the regulation of PRP — platelet-rich plasma).

“I’ve found it clinically to work,” Bell said in a recent report by MedPage Today. “Not every time, but no medicine does. But when you use it judiciously, in the correct context with the right patient and the right support, I have found it to be very effective in a high percentage of cases.”

That statement is too vague to be of any use, except as a good example of how little information, guidance, or proof of effectiveness are available.

Ioannis Papasotiriou, MD, PhD, is the founder of the Research Genetic Cancer Center (RGCC), where the SOT is made and then shipped to the U.S. for administration. It advertises “personalized cancer testing” on its website.

Papasotiriou authored the only two papers on SOT found in PubMed. The first, published in March 2022, is a preliminary study of 95 patients with cancer who received SOT. It reports that most patients had a “positive” response to treatment, based on a composite of follow-up assessments for tumor response, but there was no control group.

The second paper, published in December 2022, concluded that SOT reduced the amount of DNA of Borrelia burgdorferi, a bacteria that causes Lyme disease, and other viruses in the blood of 115 patients. It is not clear exactly what type of oligonucleotide was made for the therapy.

Also, administering the product is a challenge because oligonucleotides can be rapidly destroyed by the immune system. They may be eliminated before they can get where they need to go. It does seem that if these therapies showed promise in this context, scientists would be eager to conduct appropriate preclinical and clinical trials.

The take-home message from all this is simple: Users, be aware.