https://johncatanzaro.substack.com/p/n-of-1-trials-the-only-hope-for-long?
N-of-1 Trials: The Only Hope for Long COVID, Spike Protein Complications, and Vaccine-Injured Patients
Signal-Based Medicine | N-of-1 Trials
The Current Dilemma
The current medical system is failing those suffering from Long COVID and vaccine injuries—patients are gaslit, dismissed, and left to deteriorate without real solutions. The reason? Our healthcare model is built around randomized controlled trials (RCTs), which were never designed for individualized treatment.
What Is an N-of-1 Trial?
An N-of-1 trial is a personalized, single-patient clinical study that aligns treatment based on the individual’s unique biomolecular response. Instead of relying on population-based statistics, this method uses real-time molecular surveillance, patient-specific peptide therapeutics, and adaptive treatment adjustments to achieve true precision medicine.
Unlike traditional one-size-fits-all drug development, N-of-1 trials are built around the patient—tracking their unique exome, transcriptome, and proteome to correct faulty molecular signaling at the source.
We do not have time to wait for mass-scale trials designed for bureaucratic approval pipelines rather than real-world recovery. Lives are deteriorating daily, careers are lost, and families are crumbling. The answer is clear: we need a personalized, adaptive medical model that responds to the patient in real-time—not a slow-moving, industry-driven system.
A Stark Illustration:
Recent breakthroughs in gene-based therapies have demonstrated impressive success in conditions like spinal muscular atrophy, sparking renewed hope for addressing complex neurogenetic diseases. However, many of these interventions are designed to target specific genetic variations, and the rigid structure of traditional clinical trials has created a severe bottleneck in innovation.
Economic and bureaucratic barriers ensure that commercial development is prioritized only for high-prevalence druggable genetic variants— those deemed profitable and feasible for large-scale trials. As a result, countless patients with rare or individualized molecular disruptions are left without viable treatment options, reinforcing the urgent need for N-of-1 trials that bypass these restrictive models and deliver precision-driven solutions in real-time.
Unfortunately, this progress has not extended to Long COVID and vaccine-related injuries, where patients are suffering from Spike-protein-induced immune dysregulation, severe cardiac damage, neuroinflammation, and persistent spike-related organ damage with no viable path to treatment.
The reason is clear: traditional clinical trial models prioritize druggable conditions with large, commercially profitable patient populations while existing N-of-1 trials are still shackled by the same flawed system, failing to deliver the personalized, compassionate care that patients with complex, individualized needs urgently require. The solution is simple: individualized N-of-1 trials must operate independently, untainted by the dysfunction of the current medical research model.
The Catastrophic Failure of RCTs in Chronic Disease
RCTs were designed for standardized drug testing, not complex, multi-systemic conditions like Long COVID and vaccine injuries. These illnesses vary drastically between individuals, yet the medical system continues to force them into rigid study parameters that discard individualized responses.
Why the System Is Broken:
• Deliberate Exclusion of the Suffering – Long COVID and vaccine-injured patients don’t fit neatly into RCT parameters, so they are ignored.
• Slow, Bureaucratic Approval Processes – Years-long trials mean patients deteriorate while waiting for an answer.
• Generalized Data Over Personalized Care – RCTs focus on “majority response,” discarding those who don’t fit the mold.
This isn’t science—it’s systemic neglect.
A System Rigged Against Individualized Care
We don’t see this approach in mainstream medicine because it threatens the financial strength of the pharmaceutical industry.
• Precision-targeted treatments mean fewer mass-produced drugs—which cuts into Big Pharma’s profit margins.
• A truly individualized medical system means fewer hospitalizations, fewer unnecessary interventions, and fewer chronic patients dependent on expensive lifelong medications.
• RCT-based gatekeeping ensures only patented, billion-dollar drugs get approval—while peptide and precision small molecule therapeutics remain buried under regulatory red tape.
This system is not designed to heal people—it is designed to sustain an industry. We Can’t Afford to Wait—Patients Are Deteriorating Now (See link for article)
Further reading:
- https://www.nature.com/articles/s41591-021-01519-y
- https://jamanetwork.com/journals/jamaneurology/fullarticle/2829260?guestAccessKey=37236d8c-7c7d-4581-b9a3-a0bc7166de92&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamaneurology&utm_content=olf&utm_term=012725&adv=004812881201
- https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2425
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**Comment**
I was struck with how this article directly pertains to many of the problems in Lymeland. RCTs have been the bane of research for Lyme/MSIDS. Because mainstream medicine denies this complex illness can be chronic with persistent pathogen infection, and the inclusion of numerous coinfections, RCTs only include those who test positive on a test that misses nearly 90% of cases, and have a rash that is highly variable. Maternal-fetal transmission was identified in 1985, but it took 27 years to recognize and investigate. While ‘the powers that be’ acknowledge it can be transmitted congenitally, they still claim it’s rare. Due to this stance, doctors continue to fail to acknowledge and treat it.
Everything’s rare, until it isn’t.
The sickest patients are not represented in the research.
Madison Area Lyme Support Group 