Controversial Clinics Claim to Treat Cancer and Lyme Disease with Unsupported Oligonucleotide Therapy
The Debate Over Supportive Oligonucleotide Therapy (SOT)
Clinics around the United States claim to treat a variety of illnesses including cancer, Lyme disease, and other bacterial and viral infections using supportive oligonucleotide therapy, or SOT. While the name suggests a treatment supported by scientific data, the reality is quite different.
There is no FDA approval or research supporting the use of SOT. Although those in favor of the treatment claim it has had remarkable results treating difficult-to-fix conditions, mainstream medical professionals and organizations are warning against its use.
The Mechanics of SOT
SOT relies on oligonucleotides, short strands of RNA or DNA used for the regulation of gene expression. Two FDA-approved oligonucleotide treatments are antisense oligonucleotides (ASOs) and short interfering RNAs (siRNAs). ASOs and siRNAs work by binding to messenger RNA to increase or shut off proteins.
Although some supporters of SOT claim that it is effective, there is no scientific evidence to back up these claims. The Greek research team that has been identified as a possible supplier of SOT has only published two small papers on SOT, describing a preliminary study of ninety-five cancer patients and a Lyme disease trial for one hundred and fifteen patients. These small studies both lack the scientific methodology that clinical trials require. Furthermore, the molecules included in the preparation are not official FDA-approved medications.
The Concerns of Medical Professionals and Mainstream Organizations
While proponents of SOT argue that the personalized therapy has excellent results, medical professionals and organizations warn that SOT is unsupported and could have dangerous side effects. Dr. Mark Kay, a professor of genetics and pediatrics at Stanford University, recently called SOT a “scam,” pointing out the risks associated with using untested and unsupported treatments on patients.
In addition to the claims of those promoting SOTs, some users have reported success with their treatments. However, the lack of scientific evidence behind SOT has many medical professionals deeply concerned. The fact that SOT clinics are making promising yet unsupported claims about SOT further demonstrates the need for caution and research on SOT.
The Requirement for FDA Approval
As of now, there is no FDA approval for supportive oligonucleotide therapy. This raises serious concerns about the efficacy and safety of SOT. Many medical professionals and leaders are calling for any oligonucleotide therapy to be regulated by the FDA as a drug product. This designation would require clinical trials and substantial evidence to support its use.
The Role of Stem Cell Clinics
There is a significant parallel to the use of SOTs and the FDA’s ongoing effort to regulate stem cell clinics. Stem cell products given out in clinics across the United States have been linked to infections and severe adverse events, leading to the FDA’s recent decision to classify them as drug products. Many believe that oligonucleotide therapy should be treated in the same way.
Conclusion
While SOTs promise personalized treatment for difficult-to-fix conditions, the lack of scientific evidence supporting the use of SOT has many medical professionals worried about the risks. The role of the FDA in regulating any oligonucleotide therapy, including SOTs, must carefully be considered to ensure the safety of patients. For now, the medical community suggests caution in using SOTs due to the risks it poses.
Keywords: supportive oligonucleotide therapy, SOT, FDA approval, antisense oligonucleotides, short interfering RNAs, ASOs, siRNAs, cancer, Lyme disease, risk, personalized therapy, data, research, stem cell clinics, drug products.
Originally Post From https://www.medpagetoday.com/special-reports/exclusives/110966
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