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Thursday, 21 September 2017 13:03

Lyme testing discouraged based on a biased science

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The article 'To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis' by Dessau et al. was published on September 5, 2017. It admits something that chronic Lyme patients have known for decades: the current serological tests are invalid. However, instead of relying upon clinical diagnosis because of these poor quality tests, or using many of the more sensitive testing options that are available, the 15 authors rush to draw an odd conclusion: “Let’s limit the use of the very inaccurate tests only to those people who show the few symptoms found under the surveillance case definition for Lyme borreliosis."

New PubMed comment by dr. Sin Hang Lee

A new comment on the article was just published and summarises: “this narrative review by Dessau and colleagues contains serious scientific biases and should not be used as materials to influence public health policy decisions or as guidelines to direct clinical practice.”

Dr. Lee is the scientist who has recently sued the CDC for $ 57 million for violation of ant-trust law and the promotion of their own newly patented indirect Lyme test. In his comment he challenges the validity of the science supporting the claim to stop testing (and thus treating) patients. Here it is:

The narrative review titled “To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis” by Dessau and colleagues is a position paper of the authors. It is not a systematic review. A systemic review typically involves a detailed and comprehensive plan and search strategy derived a priori, with the goal of reducing bias by identifying, appraising, and synthesizing all relevant studies on a particular topic.

The gross biases in this position paper are: 1. Dessau and colleagues recognized “Lyme borreliosis (LB) is a tick-borne infection caused by Borrelia burgdorferi sensu lato.”, namely a bacterial infectious disease. However, the authors proposed using objective signs of clinical presentations to diagnose borreliosis, but failed to mention that the European Centre for Disease Prevention and Control requires detection of the pathogen’s nucleic acid in a clinical specimen and confirmation by DNA sequencing for diagnosis of any emerging infectious diseases, such as Ebola. According to an official publication of the United States Centers for Disease Control and Prevention, the state of the art in diagnosing infectious diseases is by molecular approaches, in particular by 16S rRNA gene analysis for bacterial infectious diseases, such as anthrax.

2. Dessau and colleagues stated that “clinicians are advised to avoid serological testing whenever the clinical symptoms are not indicative of LB according to the case definitions”. However, the case definitions which were written by some of the authors of the current position paper are “for reliable epidemiological studies and are of great value in clinical management”, not for reliable diagnosis of Lyme borreliosis. In fact, in another recent review, two of the co-authors (Strle and Hovius) of the current narrative review stated on record that “Demonstration of borrelial infection by laboratory testing is required for reliable diagnosis of Lyme borreliosis, with the exception of erythema migrans.” Therefore, at least two of the co-authors of this position paper are advancing an agenda of managing clinical patients of Lyme borreliosis, an infectious disease, without a reliable diagnosis against their own beliefs.

3. The statement “Laboratory testing for antibodies to B. burgdorferi in serum is necessary for diagnosing suspected manifestations of LB such as Lyme carditis, borrelial lymphocytoma, Lyme arthritis, acrodermatitis chronica atrophicans and possibly other rare LB manifestations” while omitting direct DNA testing of blood for the diagnosis of spirochetemia is biased. At least two of the co-authors of this position paper knew and stated that the early stage of Lyme borreliosis infections “can be treated successfully with a 10–14 day course of antibiotics”, “serodiagnostic tests are insensitive during the first several weeks of infection” and if untreated “within days to weeks, the strains of B. burgdorferi in the United States commonly disseminate from the site of the tick bite to other regions of the body.” Sensitive 16S rRNA gene analysis for the detection of Lyme borreliae in blood samples has been known since 1992. Continued suppression of using direct DNA testing for the diagnosis of early Lyme borreliosis infections is no longer acceptable.

4. The authors of this position paper emphasized “an immune response with clinical findings, such as skin lesions, neurological signs, cardiac involvement (e.g. AV block), or arthritis involving the large joints”, but avoided mentioning that cardiac involvements may be due to myocarditis caused by spirochetes invading the myocardium. The authors focused on management of the immune response in the cases of chronic Lyme neuroborreliosis because “there is no convincing evidence that B. burgdorferi produces any toxin.” It is well known that Treponema pallidum, the spirochetes causing neurosyphilis, also lacks a lipopolysaccharide endotoxin. However, it possesses abundant lipoproteins which induce inflammatory processes. Would these authors recommend not to treat patients suffering from neurosyphilis with antibiotics?

In summary, this narrative review by Dessau and colleagues contains serious scientific biases and should not be used as materials to influence public health policy decisions or as guidelines to direct clinical practice.

References can be found below the PubMed comment. Conflicts of Interest: Sin Hang Lee, MD is the director of Milford Molecular Diagnostics Laboratory specialized in developing DNA sequencing-based diagnostic tests. 

Improved version of “To test or not to test?" by Gotcha F

A group of anonymous authors who call themselves ‘Gotcha F’ - "Scientists United Against Anti-Science Shills" - improved the original article by making it more honest. You can find it here.

A letter to the CDC

Dr. Lee recently also wrote a letter to the new director of the CDC about this global public health concern. This letter will be published soon. 


Read 2950 times Last modified on Thursday, 10 October 2019 18:29

Huib Kraaijeveld

Initiator On Lyme Foundation