Comment from Vinu Arumugham
AnonymousOpposeIndividual
Summary: The commenter argues that gene therapy is fundamentally flawed because the immune system will recognize the introduced "good genes" as foreign neoantigens, leading to immune rejection and potentially severe autoimmunity. They contend that the FDA lacks an understanding of these basic immunological concepts and that gene therapy will be largely ineffective or harmful.
Due to molecular mimicry, the thousands of proteins that are contained in vaccines, induce autoimmunity against every part of the human body. That includes processes involved in maintaining genetic integrity.
https://pdmj.org/papers/epitope_analysis
So genetic defects themselves can be iatrogenic.
DNA mutations can alter proteins produced by a cell. Such altered proteins (neoantigens) are targeted by the immune system. Cancer immunosurveillance by the immune system will detect and kill all these cells. Gene editing is indistinguishable from natural DNA mutation. So gene therapy is basically artificial DNA mutation that is indistinguishable from cancer. Same for organ transplants. Transplanted organs are slightly different from self and are indistinguishable from cancer. Thus they are all attacked and rejected. So gene edited cells will be killed by the immune system and gene therapy will be defeated. Worse? The autoimmunity induced (neoantigen molecular mimicry to self antigen, defective protein molecular mimicry to protein corrected by gene editing) may even kill normal/untreated cells due to cross reaction. The "cure" can become worse than the disease.
https://pmc.ncbi.nlm.nih.gov/articles/PMC81135/
Dr. Robert Malone explains in (https://www.malone.news/p/when-is-mrna-not-really-mrna?s=r):
"2) What about the immune system? Well, this was one of my breakthroughs way back in the late 1980s. What Ted (Friedman) originally envisioned was the simple idea that if a child had a genetic birth defect causing the body to produce a defective or not produce a critical protein (such as Lesch-Nyhan syndrome or Adenosine Deaminase Deficiency), this could be simply corrected by providing the “good gene” to complement the defect. What was not appreciated was that the immune systems of these children were “educated” during development to either recognize the “bad protein” as normal/self, or to not recognize the absent protein as normal/self. So, introduction of the “good gene” into a person’s body would cause production of what was essentially a “foreign protein”, resulting in immunologic attack and killing of the cells which now have the ‘good gene”."
If the FDA cannot understand such basic concepts, how can you regulate gene therapy? Your only mention of immunosuppression is in the context of DILI. But every gene therapy will need immunosuppression to "work". So in most cases gene therapy would be useless.
