Falling back to the Dark Ages – EMEA’s statement concerning the new German guideline on “tiredness”

In Germany, a revised guideline on "tiredness” has been issued in January 2012: the notorious Leitlinie Müdigkeit. The Deutsche Gesellschaft für Allgemeinmedizin (DEGAM) corresponds to the British NICE and is in charge of issuing medical guidelines. These revised Leitlinie Müdigkeit also includes ME/CFS (Myalgische Enzephalomyelitis/Chronic Fatigue Syndrome), a disease which is classified in ICD-10 as disease of the nervous system (chapter VI) as G93.3.

However, in violation of the WHO classification ME/CFS is described throughout the guideline as mental and behavioural disorder according to chapter V of ICD-10. The authors of the revised guideline on „tiredness“ ignore the fact that ME/CFS is not a mental or behavioural disorder but a severe neuro-immunological multisystem disease of as yet unknown origin.

Ignorance and denial of the state of the art

The guideline completely ignores the extensive body of medical evidence on the characteristic biomedical abnormalities even though patient groups submitted lots of studies proving these abnormalities. They ignore, for instance, studies like that of the Norwegian oncologists Fluge and Mella who showed that at least 50% of their ME/CFS patients greatly improved with the immunomodulatory drug Rituximab.

Instead the guideline exclusively reflects the Wessely school’s “biopsychosocial model“. The German guideline draws all its conclusions regarding diagnosis and treatment from the contested British NICE guideline where even its principal investigator Michael Sharpe conceded that it is not a study on ME/CFS but on idiopathic states of fatigue.

Accordingly, also the treatment recommendations are pervaded by the ideas of the biopsychosocial model. The German guideline stipulates that further diagnostics have to be avoided because they allegedly had an “iatrogenic pathogenic potential” and would only strengthen the false illness beliefs of the patient, thus likewise “somatisising” patient and doctor.

The only recommended treatment options are cognitive behavioural therapy and graded exercise therapy (CBT and GET). Even though the authors state that in doing GET „patients should avoid overexertion“ the authors negligently ignore the vast body of literature giving evidence of the dangers of physical exertion and its proven detrimental effect on people with ME/CFS. They ignore the manifold studies showing that physical training fuels the disease mechanisms, the immunological and neuroendocrine abnormalities in this disease.

Even though the German guideline mentions the Canadian Consensus Criteria they never draw any conclusions from it with regard to diagnosis and treatment. On the contrary, they grossly distort the message of the CCC and, by false translation, maintain that the CCC would describe a state of “tiredness”.

The guideline causes harm to people with ME/CFS

The false description of ME/CFS has profoundly damaging effects on patients.

The guideline is an instruction for systematically misdiagnosing ME/CFS as a depression or another mental disorder. If a physician follows the instructions of that guideline he will inevitably misdiagnose ME/CFS and not realise that it is an organic disorder. Consequently the patients will be referred to psychiatrists and will be forced to undergo “activation therapy” in psychosomatic clinics, leading to further damage.

As a consequence of this „blaming the patient“-strategy patients will be denied social benefits. The guidelines support the unsubstantiated prejudice that patients have a self-inflicted behavioural disorder. Illness is redefined as deviance and physical activation is declared as the magic bullet. Patients who are not able to follow the treatment regime are blamed for the persistence of their disease.

The patients’ plight is perpetuated

Thus, the „new“ German guideline will greatly contribute to the perpetuation of the plight of ME/CFS patients in Germany. Instead of providing information on the devastating effects of this disease it is depicted and belittled as an extreme state of “tiredness”. Instead of providing guidance for an appropriate diagnosis and management of ME/CFS both physicians and their patients are misled. Instead of reflecting the state of the art the guidelines spread the unsubstantiated myths of the Wessely school. Instead of differentiating between states of fatigue and the distinct disease entity ME/CFS they mix everything together, in an attempt to make the disease disappear. Instead of following the example of the Norwegian health minister who recently officially apologized to the ME/CFS patients for decades of neglect and mistreatment and who retracted the respective guideline, the authors of the German guideline chose to perpetuate this very neglect and mistreatment.

Patients protest in the strongest terms against the German „Leitlinie Müdigkeit“

On being presented with the new German guidelines the European ME Alliance protests in the strongest terms against the revised German Leitlinie Müdigkeit. The guideline grossly neglects the obligation to exercise medical diligence, to an extent that might even be indictable according to German law. The guideline’s treatment recommendations for ME/CFS are an instigation to deliberate and grossly negligent physical injury. The guideline violates in many respects the code of medical ethics which stipulates the obligation for advanced vocational training, the obligation to care for patients with appropriate diagnostic and treatment approaches, and which forbids unreasonable promises of cure.

We ask the persons and institutions in charge to immediately withdraw this “Leitlinie Müdigkeit” and to issue guidelines for ME/CFS which reflect the state of medical art. Further we ask that they drop the unreasonable myths of the Wessely school, and the "biopsychosocial model”, which even the Wessely school itself now state are not appropriate for ME/CFS. And we ask them to take into consideration the vast body of medical evidence with regard to the physical abnormalities in this debilitating disease.

References

·         Die „neuen“ Leitlinien Müdigkeit über „CFS“ – ein Zerrbild medizinischer Wissenschaft und Verantwortung? Regina Clos http://www.cfs-aktuell.de/februar12_1.htm

·         DEGAM-Leitlinie Nr. 2: Müdigkeit - Update 2011 http://leitlinien.degam.de/index.php?id=72

·         German version of ICD-10: ICD-10-GM Version 2012Internationale statistische Klassifikation der Krankheiten und verwandter Gesundheitsprobleme, 10. Revision, German Modification, Version 2012 http://www.dimdi.de/static/de/klassi/diagnosen/icd10/htmlgm2012/index.htm#VI

·         Studies and articles on the effect of physical activity in ME/CFS and related pathophysiology: http://www.cfs-aktuell.de/Studien%20zu%20GET.pdf

·         Surveys on the effectiveness of CBT/GET in ME/CFS: http://www.cfs-aktuell.de/Umfragen%20zu%20GET.pdf

·         Magical Medicine: How to Make a Disease Disappear, Malcom Hooper http://www.investinme.org/Documents/Library/magical-medicine.pdf

·         Documented involvement of viruses in ME/CFS, Margaret Williams http://www.investinme.org/Article-365%20Documented%20involvement%20of%20viruses%20in%20ME%20CFS.htm

·         Margaret Williams: Comments on the NICE guidelines http://www.meactionuk.org.uk/Comments_on_the_NICE_Guidelines.htm  German version: http://www.cfs-aktuell.de/februar12_3.htm

·         Quotable Quotes about ME/CFS, Margaret Williams  http://www.meactionuk.org.uk/Quotable_Quotes_Updated.pdf  Excerpts in German: http://www.cfs-aktuell.de/februar12_2.htm

·         Questions for Professors Frank J M van Kuppeveld and Jos W M van der Meer, Margaret Williams http://www.meactionuk.org.uk/Question-for-Professors-van-Kuppeveld-and-van-der-Meer.htm German version:  http://www.cfs-aktuell.de/februar12_6.htm

·         Defending the Indefensible, Margaret Williams, http://www.meactionuk.org.uk/Defending-the-indefensible.htm  German version: http://www.cfs-aktuell.de/februar12_4.htm

·         Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study, Fluge/ Mella http://www.plosone.org/article/info:doi/10.1371/journal.pone.0026358

·         Immunological abnormalities as potential biomarkers in Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis Journal of Translational Medicine 2011, 9:81 doi:10.1186/1479-5876-9-81 Ekua W Brenu, Mieke L van Driel, Don R Staines, Kevin J Ashton, Sandra B Ramos, James Keane, Nancy G Klimas, Sonya M Marshall-Gradisnik  http://www.translational-medicine.com/content/9/1/81    

·         Myalgic Encephalomyelitis/Chronic Fatigue Syndrome A Clinical Case Definition and Guidelines for Medical Practitioners http://sacfs.asn.au/download/consensus_overview_me_cfs.pdf  German version: http://www.cfs-aktuell.de/Konsensdokument.pdf