Clinical Care as Research

The effects of ubiquitous exposures cannot be studied in the late modern way. Fortunately, the groundwork of emerging methods has already been laid for causal thinking, exposure assessment, outcome definition, and study design as well as self-patterning for discovery, as noted below.

Updating Causal Thinking

The context of epidemiology and public health practice is reasonably well-developed for infectious disease and in need of development for chronic illness. The incorporation of ecological frames by Mervyn Susser with a historical perspective, revealed the complexity of useful causal thinking for this purpose, but his reliance on statistical modeling for the complex study of exposures with diverse metabolic consequences requires a body of clinical research that has ceased to develop. Computational models with one or two “main effects” and perhaps one “interaction” may work for overwhelming causal factors, such as smoking and coal mining in lung cancer, but are too simplistic to elucidate causal webs in daily life. A quick comparison between the Krebs cycle, the electron transport chain, or the life cycle of Plasmodium falciparum and the average policy-oriented either/or statistical model will reveal that the latter is far too blunt an instrument to probe the unknown in intricate, dynamic biological systems that are active from the date of conception and before. Note that even the very simplest causal model includes agent, host, and environment, each of which is too complex for any simplistic model. In sum, data cannot yield solutions when problems demand knowledge and wisdom born of carefully-observed experience in vivo and in situ in free-living populations.

Assessment of Complex and Ubiquitous Exposures

While technology continues to dazzle, the thinking behind assessment for the purposes of health studies does not, especially with regard to non-ionizing radiation. Many investigators rely on electricians and other technicians who lack knowledge of biology and do the best they can with what they have. When investigators lack comprehension of etiopathogenesis and/or fail to comprehend physics, it is no surprise that studies of electromagnetism and its health effects ignore key questions of dosages and consequences. Patients turn to the construction industry for protection, and contractors rely on products. Such solutions are decontextualized from biological reality as evolved prior to late modernity, and thus from the human body and from the as-yet barely considered body of life and its earthly substrates. A Cal Tech study on the impact of geomagnetic fields illustrates the kinds of skills needed to assess the impact of the earth on humans.

In assessing chronic exposure as a cause of chronic illness, the brief catastrophic exposure that may be recognized by doctors of occupational medicine is unlikely to be missed by them, or to account for many cases of emerging conditions. That pattern of chronic exposure and consequences—such as the failure of tolerance illustrated above, and the body of experiential learning assembled by building “biologists” and by the community at Greenbank—point to doses of radiation varying by patterns of frequency and power over time, with lifetime effects cumulating, combining, and/or interacting with other sources of poison as well as with metabolic factors.

Metabolic factors and conventional food from distant sources may have the greatest impacts on outcome, and so obscure the effects of radiation. Also important are failures of tolerance, pre-natal and early childhood exposures, microbiome effects, and the poison “cocktail,” its metabolites, and rates of absorption/production relative to rates of excretion and recovery. In sum, route, source, or other narrow exposure assessments are likely to miss effects regardless of how long or large or sophisticated the associated data collection may be. Assessment should include all routes of exposure:

• Ingestion of conventional foods that include a variety of poisons, or contaminated organic food;
• Ingestion of unclean water (e.g. poisoned well or surface water);
• Inhalation of sulfur dioxide and other pollutants, especially in combination with allergens;
• Penetration by non-ionizing radiation in the electromagnetic range; and/or
• Absorption of household or workplace chemicals through the skin or other routes.

Note that because the dissemination of poisons has made them virtually ubiquitous, there is no normal—that is, no unexposed group—for comparison in any study. Only elimination studies can be effective. Note also that recovery takes years, not days.

Outcome Definition

Cases of the emerging epidemics, especially ME/CFS (now subsumed by CAP), are notoriously difficult to count as they may present differently depending on poison cocktail, metabolism of poisons, end-organ sensitivity, and loss of tolerance. As per Ziem and McTanney, “multiple overlapping disorders” relate to a wide spectrum of poisons and a variety of process of “injury” such as: “neurogenic inflammation,” “kindling and time-dependent sensitization”, “impaired porphyrin metabolism” and “immune activation.” Given the repurposing of neurotoxic agents of biological warfare for application to crops and the widespread contamination of croplands and foods, neurotoxicity and related injury to organ function and structure begs examination. However, there is no reason to believe that cancer, obesity, cirrhosis, and other end-stage diseases are not catalyzed by chemical exposures. Self-report and clinical diagnosis with case series and N-of-1 interventions to arrest or reverse damage should be offered without delay. Note that there is no gold standard that can be used to form treatment groups for study, and there may never be one.

The Emerging N-of-1 Study Method

A deterministic study in a single patient may arrest or even, with early intervention, reverse disease. The “N-of-1” design has many, many advantages over all other prospective and retrospective designs, including the present clinical gold standard—the expensive and fallible randomized, triple-blind, placebo-controlled trial used for new pills. The advantages include:

1. No outside funding needed.
2. No wait required.
3. Responsive to learning and resilient to frame and construct changes.
4. No assumption that everyone is the same.
5. No assumption that whatever preoccupies the investigator or the medical literature, or whatever expectations may be limiting them, are relevant to the case.
6. The study subject has the perfect control subject—that is, the intervention and control subjects are one in the same person.
7. The design controls for any number of unknown factors such as genes and modifiers of gene expression—free from the limits of statistical models that may suit policy analysis but do not suit biology, medicine, or continuous and resilient learning.
8. A patient can—with enough clinical knowledge or a doctor who is free of top-down control and possessed of sensible, high-integrity curiosity—use this design over and over again until the problem is solved.
9. The patient can revise the search for causes as soon as new knowledge is gained, and begin again immediately if need be.
10. Patients can share what they learn if so inclined. However, the goal self-care and cure. There is no obligation to adhere to academic standards, or to develop the skills necessary to take care of others who may differ in cryptic ways.

In the reported self-study, a teacher of study design used this method intuitively and without the help of an expert governed by arbitrary and ill-fitting standards. A prepared clinician can help untutored patients do the same.