The Critical Importance of Molecular Biomarkers and Imaging in the Study of Electrohypersensitivity. A Scientific Consensus International Report.

Clinical research aiming at objectively identifying and characterizing diseases via clinical observations and biological and radiological findings is a critical initial research step when establishing objective diagnostic criteria and treatments. Failure to first define such diagnostic criteria may lead research on pathogenesis and etiology to serious confounding biases and erroneous medical interpretations. This is particularly the case for electrohypersensitivity (EHS) and more particularly for the so-called "provocation tests", which do not investigate the causal origin of EHS but rather the EHS-associated particular environmental intolerance state with hypersensitivity to man-made electromagnetic fields (EMF). However, because those tests depend on multiple EMF-associated physical and biological parameters and have been conducted in patients without having first defined EHS objectively and/or endpoints adequately, they cannot presently be considered to be valid pathogenesis research methodologies. Consequently, the negative results obtained by these tests do not preclude a role of EMF exposure as a symptomatic trigger in EHS patients. Moreover, there is no proof that EHS symptoms or EHS itself are caused by psychosomatic or nocebo effects. This international consensus report pleads for the acknowledgement of EHS as a distinct neuropathological disorder and for its inclusion in the WHO International Classification of Diseases.

The inadequacies of pre-market chemical risk assessment's toxicity studies-the implications.

Industry provides essentially all the data for most (pre-market) chemical risk assessments (RA); academics study a chemical once it is marketed. For two randomly-chosen high production chemicals, despite new European Union mandates to evaluate all data, just 13% of the herbicide bentazon and 15% of the flame-retardant hexabromocyclododecane's published toxicity studies were found in their pre-market RA, and a systematic review on bentazon concludes it has greater hazards than indicated in its RA. More important, for both, academia's toxicity studies were designated as lower quality than industries were, despite showing hazards at lower doses. The accuracy of industry's test methods is analyzed and found to be replicable but insensitive, thus inaccurate. The synthetic pharmaceutical industry originated them, and by 1983 the Organization for Economic Cooperation & Development mandated their test guidelines (TG) methods be accepted for any new study for pre-market RA. For existing studies, industry's "Klimisch" criterion is universally used to evaluate quality, but it only states that TG studies produce the best data. However, no TG can answer the realistic exposure effect hypotheses of academics; therefore, crucially in pre-market RA, tens of thousands of published experimental findings (increasingly at low dose) are ignored to determine the safe dose. Few appreciate this, so scientific debate on the most accurate elements of toxicity tests is urgently indicated. Copyright © 2016 John Wiley & Sons, Ltd.

Risk assessment's insensitive toxicity testing may cause it to fail.

BACKGROUND: Risk assessment of chemicals and other agents must be accurate to protect health. We analyse the determinants of a sensitive chronic toxicity study, risk assessment's most important test. Manufacturers originally generate data on the properties of a molecule, and if government approval is needed to market it, laws globally require toxicity data to be generated using Test Guidelines (TG), i.e. test methods of the Organisation for Economic Cooperation and Development (OECD), or their equivalent. TGs have advantages, but they test close-to-poisonous doses for chronic exposures and have other insensitivities, such as not testing disease latency. This and the fact that academic investigators will not be constrained by such artificial methods, created a de facto total ban of academia's diverse and sensitive toxicity tests from most risk assessment. OBJECTIVE: To start and sustain a dialogue between regulatory agencies and academic scientists (secondarily, industry and NGOs) whose goals would be to (1) agree on the determinants of accurate toxicity tests and (2) implement them (via the OECD). DISCUSSION: We analyse the quality of the data produced by these incompatible paradigms: regulatory and academic toxicology; analyse the criteria used to designate data quality in risk assessment; and discuss accurate chronic toxicity test methods. CONCLUSION: There are abundant modern experimental methods (and rigorous epidemiology), and an existing systematic review system, to at long last allow academia's toxicity studies to be used in most risk assessments.