Three hundred people who consider themselves to have Lyme disease will file a criminal complaint in early January 2018. They are notably asking for the withdrawal of ELISA screening tests, which they say are unreliable. An assertion contrary to all French and international scientific data.
They are 300, who are said to be suffering from Lyme disease, to come together for a collective complaint unprecedented in France. The conflict is based on the non-recognition of their disease as such by medicine on the grounds that the ELISA and Western-Blot tests do not diagnose the disease they claim to have.
At the beginning of January 2018, they will attack, in criminal proceedings, the State, the National Agency for the Safety of Medicines and Health Products (ANSM) and the National Reference Center (CNR) of Strasbourg, reveals RMC.
A grouped complaint for influence peddling, abuse of corporate assets and concealment of abuse of corporate assets, endangering the lives of others, violation of the principle of independence of experts and of the principle of absence of conflict of interest.
Questioning validated tests
For these patients, screening tests for this bacterial disease, caused by a tick bite, are unreliable. In France, there is only one validated test, the ELISA test. If positive, it is confirmed by another test, the “Western-Blot”. In the event of negativity, it is not controlled because its sensitivity is sufficient at the stage of the state of the disease, to such an extent that its negativity in the event of arthritis for example, must call into question the diagnosis.
The problem, according to these people, is that the ELISA test only detects “three to five bacteria that can cause disease when in reality there are more than a dozen.” An assertion which is based on a real diversity of borrelia species in Europe, but the disease is really only caused by a small number of them.
The ELISA test is based on an immunoenzymatic reaction which makes it possible to find in the serum of patients the antibodies they have produced against the antigen of the bacteria. While in the past there have been variations in the performance of the various tests offered, all the work of the CNR has consisted in harmonizing these tests and, since 2013, only validating tests with sufficient sensitivity and specificity.
A variable geometry diagnosis
Faced with certain persistent non-specific symptoms, some patients consider themselves to be suffering from “chronic Lyme disease”, a condition which is not recognized by French medicine, nor internationally. In order to be sure they have the disease, some people go so far as to do veterinary tests, deemed “more accurate”, or go to other countries. In Germany, for example, where other tests are more easily accessible.
According to Maitre Julien Fouray, one of the lawyers of the plaintiffs, there would therefore be, currently, sick people who are still not diagnosed and they would be tens of thousands, currently in France. However, any isolated test is nothing: it must be interpreted with regard to the clinical picture to make a diagnosis of Lyme, with clinical signs which are quite characteristic. This is not the case with “chronic Lyme” where the history and clinical signs are not suggestive of borrelia infection and where the Elisa test is very often negative.
The problem is that French medicine is no exception in the world and that the consensuses of French, Belgian, Swiss, American and even German learned societies are consistent with each other. ELISA is the universal screening technique and Western Blot is a good confirmatory technique. There are other tests of course, but which are not validated by studies having all the guarantees of seriousness. This has nevertheless led to a profitable trade for the biology laboratories which lend themselves to it, in particular in Germany indeed.
Winning a Law Against Science
The 300 plaintiffs are claiming 500,000 euros in damages per patient in therapeutic wandering, and the withdrawal of these ELISA tests. With this legal action, the patients seek to highlight a possible conflict of interest between the National Reference Center (CNR) in Strasbourg and the laboratories that manufacture the tests. In the center, the director of the Strasbourg CNR, expert mandated by the State and the ANSM: “He collaborates with the laboratories which manufacture these tests”. The complainants have doubts about its independence.
At the heart of the problem, the diagnosis of Lyme disease, which is not medically validated in many people since the clinical picture they complain about is not evocative (diffuse pain, fatigue, cognitive problems, etc.) and the ELISA test is negative for them.
If we used another test, more often positive but less specific, it would cause many more “Lyme diseases” in France. So far, the French scientific authorities, including the CNR, consider that these other tests are neither specific for Lyme, nor scientifically validated. Refusing these tests, they stand in the way of recognition of Lyme disease in these patients. Note that France is consistent with what is happening in other countries.
Behind the fake Lyme, real diseases
The cause of Lyme disease is a tick bite in a forest or park, in spring or fall. A few weeks later, the sick person most often sees a lesion of the skin at the site of the bite, chronic erythema, then may appear later joint, cardiac, neurological disorders if the disease is not treated. . Arthritis, muscle pain, facial paralysis, heart problems, fever… The symptoms of Lyme disease are certainly diverse, but very characteristic, even specific, like chronic erythema migrans.
If the Lyme is treated correctly, according to the protocols, and from the disease of the skin, the bacteria are eradicated and do not reappear, except in the case of a 2nd bite by another tick (having been infected once does not protect against a 2nd infection).
There is no proven scientific evidence for the persistence of the bacteria in the body after successful antibiotic treatment. However, there are many examples of serious illnesses that have been mistaken for Lyme disease and treated too late.
It is for example tuberculosis, leukemia and lymphomas, even other more complex autoimmune diseases … There are also chronic pain syndromes, some of which are linked to “damage to small terminal nerve fibers. ”And which would be accessible to treatment in a third of cases. There are others of which we do not yet know the cause, but which will be one day, if the patients are not locked in a “chronic Lyme disease” box.
Chronic Lyme disease is not recognized by science, neither in France, nor in other countries. The Elisa test is the test validated in all European countries and the work carried out by the CNR has made it possible to correct certain imperfections that existed before 2013. On the other hand, the delay in diagnosing other diseases poses a risk of loss. luck for the sick.
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