When Lyme Is Not Lyme: CDC and FDA Policies and Medical Practice Must Be Refined to Embrace Complexities For the Good of the Patient

August 11, 2025

https://popularrationalism.substack.com/p/when-lyme-is-not-lyme-cdc-and-fda?

When Lyme Is Not Lyme: CDC and FDA Policies and Medical Practice Must Be Refined to Embrace Complexities For the Good of the Patient

Here I propose a decision-tree based differential diagnosis of Lyme and Not Lyme. It’s a start.

James Lyons-Weiler, PhD
Aug 07, 2025

In the realm of infectious disease, simplicity is seductive. It promises clear diagnoses, standardized protocols, and neat narratives. But Lyme disease—a condition with protean manifestations, shifting microbial profiles, and diagnostic challenges at every stage—refuses to conform. It insists on complexity. And in response, our institutions—particularly the CDC and FDA—have built a regime of policies that actively deny it.

The result? A generation of patients misdiagnosed, underdiagnosed, or dismissed entirely—not because they lack illness, but because the illness they carry doesn’t fit the model. The model is wrong.

This article argues that regulatory science has reached a breaking point in Lyme disease policy. The failure to recognize nuanced diagnostic tools—especially direct detection technologies like PCR and sequencing—and the overreliance on antibody-based serologic paradigms are not only outdated, they are dangerous. The bucket-labeling of chronic illness under the guise of “post-treatment Lyme disease syndrome” or “functional somatic disorder” is not science. It is avoidance. It is bureaucracy masquerading as epidemiology.

We can—and must—do better.

The Tidy Algorithm That Misses the Patient

The CDC continues to recommend a two-tier serologic testing algorithm for Lyme disease diagnosis: an initial ELISA (enzyme-linked immunosorbent assay) or IFA (indirect fluorescent antibody), followed by a Western blot. But this cascade is built around the immune system’s delayed humoral response—one that may take weeks to develop and varies wildly across individuals.

Early localized Lyme disease—the phase where diagnosis and treatment are most crucial—often produces negative antibody tests despite active spirochetemia. The immune system hasn’t had time to respond, or responds atypically. Yet this window is precisely when patients present with acute symptoms—rash, fatigue, fever, malaise—and need confirmation.

Instead, they are sent home with instructions to “wait for antibodies to develop.” It is a ritual of deferred care masquerading as prudence.

Meanwhile, molecular techniques—such as PCR amplification of bacterial chromosomal DNA followed by Sanger sequencing—can detect Borrelia burgdorferi spirochetes in the blood of these patients with precision, even at very low organismal loads. A 2024 study confirmed the utility of the flaB gene as a sensitive target for direct molecular detection. And yet, CDC officials such as Dr. Christina Nelson continue to state—without qualification—that PCR is “not useful” in the diagnosis of Lyme disease, a systemic infectious disease. This “policy statement” on Lyme diagnosis contradicts CDC’s own established protocols for infectious diseases. For example, the CDC’s diagnostic protocol for SARS-CoV-1 in 2003 recommended using three specific primers to perform heminested PCR to amplify a 348-bp genomic cDNA for sequencing “to verify the authenticity of the amplified product” The CDC scientists also used Sanger sequencing of the nested PCR products to help diagnose the first SARS-CoV-2 case in this country.

The CDC does not recommend the Widal (serologic) test for diagnosing typhoid fever, a classic bacterial systemic infectious disease, which is usually diagnosed by blood cultures.

This is not simply a matter of differing interpretations. It is institutional self-contradiction, plain and harmful. On one hand, CDC acknowledges the superiority of molecular methods in select studies. On the other, its public guidance to clinicians categorically dismisses them. The result is diagnostic nihilism, not progress.

The Adjudicated Endpoint Mirage

This failure to adopt precise diagnostics bleeds into vaccine trials—most recently, those for Pfizer and Valneva’s VLA15, a candidate Lyme vaccine. The protocol allows for adjudication committees—not direct evidence—to determine whether a patient “truly” had Lyme disease based on serologic conversion.

In other words, the gold standard is not evidence of infection, but whether enough bureaucrats agree that a positive Western blot means what they want it to mean. This is a scientific sleight-of-hand: dressing bias in the costume of consensus.

We don’t adjudicate cancer diagnoses this way. We don’t require panels to decide if a culture grows MRSA. Why do we treat Lyme disease differently?

Because the system was designed around patented serologic tools, and because acknowledging more sensitive direct tests would expose three decades of flawed public health doctrine. The regulatory apparatus has become self-protective. It resists admitting new knowledge, even when it emerges from the very labs it funds.

The Individual’s Diagnostic Pathway: A Vanishing Art

Modern medicine must reclaim a lost art: tracing the pathway of illness in the individual patient. Lyme disease—and other stealth infections—do not conform to static models. They unfold dynamically, in stages, with overlapping presentations. Co-infections with Babesia, Bartonella, Ehrlichia, or Rickettsia are common and further blur the clinical picture. Immune exhaustion, biofilm states, immune complex sequestration—none of these phenomena are accounted for in the serologic testing regime.

And yet the CDC’s official diagnostic flowchart is oblivious to all of it.

This is not a technical problem. It is a philosophical one. To see illness clearly, one must be willing to dwell in ambiguity. To build robust diagnostics, one must test them against reality—not against regulatory convenience.

When a patient walks into a clinic with chronic fatigue, joint pain, or neurological complaints, physicians now reflexively reach for either a psychiatric label or a “fibromyalgia” diagnosis if the serology is negative. This is not differential diagnosis. It is abdication. And it is rooted in federal guidance that refuses to update.

A Better Framework: Evidence, Not Adjudication

It is not difficult to build a better system. We start by acknowledging that direct detection methods—when confirmed via sequencing—constitute definitive evidence of infection. A PCR test that amplifies Borrelia DNA and confirms identity through Sanger sequencing is objective, reproducible, and not susceptible to interpretive bias. Unlike a Western blot, there is no subjectivity in band intensity or background noise.

CDC must formally revise the case definition of Lyme disease to admit these tools. It must publish updated MMWRs and notify CLIA-certified labs that sequence-confirmed molecular diagnostics are not just permitted—they are necessary. And FDA, for its part, must refuse to approve any vaccine for Lyme disease that does not use culture-positive or sequencing-positive endpoints in its efficacy trials.

The adjudication committee must go the way of the phlogiston theory. It is an epistemic relic.

The Stakes: Chronic Illness Mismanagement on a National Scale

When Lyme is misdiagnosed, the result is not just diagnostic error. It is years of compounded harm—neurological decline, systemic inflammation, misprescribed psychiatric drugs, and social marginalization. And when regulators misdefine illness, insurance companies follow suit, refusing reimbursement for testing or treatment that strays from the flawed algorithm.

Thus, a person with real infection is told they are imagining it, or “have something else.” They are sent to psychiatrists, subjected to medications they don’t need, and denied the very antibiotic or herbal therapies that could help them.

This is not merely negligence. It is institutionalized medical error.

And the cost is not just individual. It is civilizational. When truth is buried beneath layers of bureaucratic adherence, science becomes theater.

Complexity Is Not the Enemy

To fix Lyme disease policy, we must abandon the false comfort of simplicity. Illness is not simple. Infection is not static. Patients are not algorithms.

The CDC and FDA must evolve to meet the complexity of this pathogen. And physicians must be permitted—indeed encouraged—to follow the diagnostic trail wherever it leads, even if that means sequencing a pathogen the government pretends not to see or looking for autoimmunity due to pathogenic priming from aluminum-containing vaccines that mimics Lyme.

In the end, it is not Borrelia burgdorferi that threatens public health the most. It is the system that refuses to learn from its past, revise its models, or admit that sometimes… Lyme is not just Lyme.  (See link for article)

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Activism, Lyme, Testing, Treatment

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