Sundheds- og Ældreudvalget 2015-16
B 25 Bilag 8
Offentligt
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Problematikken omkring patienter med flåtbårne infektioner
Opfølgning på foretræde for Folketingets Sundheds- og Ældreudvalg d. 12/1-2016
Vi vil gerne takke udvalgets medlemmer for Jeres tid samt Jeres interesse i patienternes
problemer. Til både de tilstedeværende medlemmer, og til dem som ikke kunne være
tilstede, har vi opsummeret på tre sider vores vigtigste punkter:
1.
Imod de gældende retningslinjer for diagnostik af flåtbårne infektioner foretages der ofte
ikke et lægefagligt skøn af patienter, der får symptomer efter en flåtbid. Er der mistanke
om borrelia, må der ifølge retningslinjerne udelukkende bruges en serologisk ELISA
(enzyme-linked
immunosorbent assay)
test, der i den lægevidenskabelige faglitteratur
(se ‘Henvisninger’ på side 4) er kendt for, at den kun fanger ca. 50% af infektionerne og
dette også efter infektionens akutte fase.
Allerede i 2002 anerkender Sundhedsstyrelsen i et brev (Bilag 1) til Flemming Bo
Andersen, at denne test ikke er tilfredsstillende. Over tretten år senere – og efter, at
tusindvis af personer er blevet nægtet behandling og er blevet kronisk syge efter et falsk
negativt ELISA testresultat – har Sundhedsstyrelsen ikke godkendt nogle alternativer til
ELISA testen.
2.
Uden et positivt testresultat fra en ELISA test får man som regel ingen behandling. De
hundredevis af patienter, der får et falsk negativt resultat, får derfor en fejldiagnose (ofte
psykisk) og efterlades uden hjælp fra sundhedssystemet. Patienter, der ikke bliver raske
efter den tilladte behandling (én eller i ekstreme tilfælde to kur med bredspektrede
antibiotika i 10-15 dage), bliver ligeledes sendt hjem med en fejldiagnose. Da disse to
grupper af patienter hermed forsvinder fra sundhedssystemets radar, usynliggøres
problemets omfang. Men omkostningerne – både menneskelige og økonomiske –
forsvinder ikke.
Under den 1. behandling i Folketinget af Beslutningsforslag B25 den 11/12-2015 blev der
spurgt, hvor meget en ny strategi for behandling af patienter med flåtbårne sygdomme
ville koste. Men i stedet kan man faktisk spørge, hvor meget samfundet kan spare.
Prisen på en medicinal behandling er forholdsvis lav, prisen på en kronisk invaliderende
sygdom derimod meget høj.
Koster hver patient med en ubehandlet invaliderende flåtbåren sygdom samfundet
200.000 Kr. om året (konservativt skøn), og har hver patient en gennemsnitlig forventet
levetid på 35 år med sygdommen, vil de samlede omkostninger for samfundet over disse
patienters levetid være 7 milliarder Kroner per 1000 patienter.
4.
Ifølge Statens Serum Institut er bid fra skovflåter hvert år skyld i, at ”mindst 20.000
mennesker i Skandinavien bliver ramt af infektioner. ”
http://www.ssi.dk/Aktuelt/Forskningsnyt/2015/2015_09%2065%20millioner%20kroner%2
0til%20forskning%20i%20sygdomme%20fra%20skovflater.aspx
Ud fra en gennemsnitsberegning af indbyggertal, så svarer det til, at 5.500 personer i
Danmark testes positiv via ELISA (den eneste anerkendte test i Skandinavien) for en
flåtbåren infektion hvert år. Idet den ELISA test er kendt for kun at fange ca. 50% af
infektionerne, kunne det være, at op til 5.500 personer om året i Danmark får falske
negative resultater og bliver derfor fejldiagnosticeret med fysiske tilstand som fx
3.
Problematikken om patienter med flåtbårne infektioner
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sklerose, fibromyalgi, ME (myalgic
encephalopathy),
CFS (chronic
fatigue syndrome)
eller psykiske tilstand som fx såkaldte funktionelle lidelser.
5.
I de internationale lægevidenskabelige tidsskrifter ser man selvfølgelig forskningsartikler,
der underbygger dele af de danske eksperters klaringsrapport om borrelia infektioner.
Men der findes uden overdrivelse hundredevis af artikler i de samme tidsskrifter, der
modsiger direkte centrale elementer i eksperternes position (se ‘Henvisninger’ på side
4).
Som ramme for behandling af patienter med persisterende flåtbårne infektioner
anbefaler vi Verdenslægeforeningens Helsinki Deklaration, seneste udgave fra 2013,
Artikel 37:
I forbindelse med behandling af en patient, hvor der ikke eksisterer
dokumenterede profylaktiske, diagnostiske og terapeutiske metoder, eller
hvor andre kendte metoder har vist sig at være resultatløse, har lægen efter
at have hentet råd fra eksperter og med informeret samtykke fra patienten
eller patientens værge ret til at benytte udokumenterede eller nye
profylaktiske, diagnostiske og terapeutiske metoder, hvis de efter lægens
skøn giver håb om at redde liv, genopbygge helbredet eller lette lidelser. Hvis
det er muligt, skal der forskes i disse metoder med henblik på at evaluere,
hvor sikre de er, og hvor godt de virker. I alle tilfælde skal ny information
journaliseres og, hvis det er hensigtsmæssigt, offentliggøres.
Originalteksten på engelsk findes på World Medical Association
s hjemmeside:
http://www.wma.net/en/30publications/10policies/b3/
En udgave af deklarationen vedtaget i 2000 på Verdenslægeforeningens Edinburgh
Konference ligger i officiel dansk oversættelse på den danske Lægeforeningens
hjemmeside:
http://www.laeger.dk/portal/page/portal/LAEGERDK/Laegerdk/R%C3%A5dgivning%20o
g%20regler/ETIK/WMA_DEKLARATIONER/HELSINKI_DEKLARATIONEN
7.
Der er eksperter i udlandet med årtiers erfaring inden for behandling af flåtbårne
sygdomme, som er uenige med de danske eksperter, og regeringer på verdensplan
begynder nu at lytte til dem. På dette link:
https://youtu.be/SXxWxMuUh8w
kan man se den amerikanske ekspert Doctor Richard Horowitz’s præsentation til den
belgiske senat. Horowitz har også givet præsentationer til franske og japanske
parlamentariker. Han har måske hellere ikke monopol på sandheden, men han er
ekspert i behandling af borreliapatienter, han opnår bedre resultater, end man opnår i
Danmark, og han modsiger markant de danske eksperter på nogle kritiske punkter. Vi
mener, at man i Danmark burde høre, hvad Horowitz og andre eksperter har at sige, ikke
mindst i forbindelse med ekspertmødet, som Sundhedsstyrelsen nu forventes at holde i
løbet af 2016.
8.
En ekspert kan ikke være bedre end den viden, som er tilgængelig på den pågældende
tidspunkt. For eksempel: før 1982 var det ifølge eksperterne kvaksalveri at give
antibiotika til en patient for at behandle en mavesår. Det kunne en læge faktisk miste sin
autorisation på. Men siden offentliggørelsen af Marshall og Warrens forskning om
6.
Problematikken om patienter med flåtbårne infektioner
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Helikobakter pylori er antibiotika blevet en anbefalet behandlingsform for mange typer
mavesår.
Er den videnskabelige kortlægning af et område mangelfuld, kan det ikke undgås, at
ekspertviden på området også vil være mangelfuld.
9.
Ifølge Sundhedsstyrelsen læner Danmark sig op ad de amerikanske eksperter og
retningslinjer på området. Men der er delte meninger blandt eksperterne i USA. Danmark
læner sig kun op ad ekspertgruppen tilknyttet til det medicinske selskab IDSA (Infectious
Diseases Society of America) til trods for, at ekspertgruppen tilknyttet til det medicinske
selskab ILADS (International Lyme and Associated Diseases Society) har i de seneste år
udarbejdet retningslinjer, der er evidensbaserede. Disse retningslinjer er i virkelighed
bedre dokumenterede end IDSA retningslinjerne, da de i modsætning til IDSA
retningslinjerne lever op til de seneste IOM (Institute of Medicine) kvalitetskrav. Siden
september 2015 er ILADS retningslinjer godkendt og offentliggjort af den statslige NGC
(National Guidelines Clearinghouse) i USA på lige fod med IDSA retningslinjerne:
https://www.guideline.gov/search/search.aspx?term=lyme
CDC (Centers for Disease Control and Prevention) i USA og Sundhedsstyrelsen i
Danmark anerkender udelukkende IDSA retningslinjerne, men ifølge en undersøgelse
foretaget af CDC i 2013 behandler i virkelighed under 50% af de amerikanske læger
efter IDSA retningslinjerne:
http://www.poughkeepsiejournal.com/article/20130915/NEWS01/309150044/Doctors-
bucking-Lyme-protocols
I CDC undersøgelsen svarede 56% af patienterne, at deres læge afveg fra IDSA
retningslinjerne.
10. Vi er ikke trygge ved, at den danske sundhedspolitik og patienternes skæbne på dette
problematiske område overlades til en gruppe nedsat af tre
foreninger / private
foreninger
(Dansk Selskab for Klinisk Mikrobiologi, Dansk Selskab for Infektionsmedicin
og Dansk Neurologisk Selskab), som det fremgår af det Centrale Virksomhedsregister.
Interessekonflikten i denne gruppe er nu velkendt:
http://www.information.dk/231920
Det må som et minimum anses for problematisk, at gruppen anerkender udelukkende
ELISA som diagnostisk test for borrelia samtidigt med, at én af gruppens medlemmer har
en økonomisk interesse i salget af netop denne test.
11. Vi ser positivt på Sundhedsstyrelsens plan om at holde et ekspertmøde i løbet af 2016,
hvor bla. patientrepræsentanter vil blive inviteret. Vi ønsker at deltage i ekspertmødet.
15. januar 2016 – Else Wiese, Ib Lauritsen, Martin Jack
Ønsker man dokumentation eller yderligere oplysninger, står vi gerne til disposition:
Martin Jack
[email protected]
Tlf. 21675904
Else Wiese
[email protected]
Tlf. 20731365
Ib Lauritsen
[email protected]
Tlf. 40302234
Problematikken om patienter med flåtbårne infektioner
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Henvisninger
ELISA testens ringe sensitivitet
Den lave sensitivitet af ELISA testen dokumenteres i følgende artikler:
1.
Schmitz et al. Comparison of seven commercial kits for detection of antibodies to
Borrelia burgdorferi. European Journal of Clinical Microbiology and Infectious
Diseases
12: 419-24.
Engstrom S.M. et al. Immunoblot interpretation criteria for serodiagnosis of early
Lyme disease. Journal of Clinical Microbiology
33: 419-27.
Oksi J. et al. Antibodies against Whole Sonicated Borrelia burgdorferi Spirochetes,
41-Kilodalton Flagellin, and P39 Protein in Patients with PCR- or Culture-Proven
Late Lyme Borreliosis. Journal of Clinical Microbiology 1995 33 (9): 2260–64.
Ledue T.B., Collins M.F., Craig W.Y. New laboratory guidelines for serologic
diagnosis of Lyme disease: evaluation of the two-test protocol. Journal of Clinical
Microbiology 1996: 34: 2343-50.
Trevejo R.T. et al. Evaluation of Two-Test Serodiagnostic Method for Early Lyme
Disease in Clinical Practice. Journal of Infectious Diseases
179: 931-38.
Nowakowski J. et al. Laboratory Diagnostic Techniques for Patients with Early Lyme
Disease Associated with Erythema Migrans: A Comparison of Different Techniques.
Clinical Infectious Diseases
33: 2023-27.
Bacon R.M. et al. Serodiagnosis of Lyme Disease by Kinetic Enzyme-Linked
Immunosorbent Assay Using Recombinant VlsE1 or Peptide Antigens of Borrelia
burgdorferi Compared with 2-Tiered Testing Using Whole-Cell Lysates. Journal of
Infectious Diseases
187: 1187-99.
Coulter P., Lema C. et al. Two-year evaluation of Borrelia burgdorferi culture and
supplemental tests for definitive diagnosis of Lyme disease. Journal of Clinical
Microbiology
43(10): 5080-84.
Steere A.C. et al. Prospective study of serologic tests for Lyme disease. Clinical
Infectious Diseases
47: 188-95.
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10. Binnicker M.J. et al. Evaluation of two commercial systems for the automated
processing, reading and interpretation of Lyme Western blots. Journal of Clinical
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11. Klemann W., Huismans B.D. Patienten mit Erreger- Direktnachweis bei chronischer
Lyme-Borreliose: Klinik, Labordiagnostik, Antibiotika-Therapie und
Krankheitsverlauf. Umwelt-Medizin-Gesellschaft
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12. Wojciechowska-Koszko et al. Serodiagnosis of borreliosis: indirect
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59(1):
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Persistens af Lyme borreliose
Borrelia infektionernes evne til at overleve antibiotikabehandlinger dokumenteres i følgende
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Akin E, McHugh Gl, Flavell RA, Fikrig E, Steere AC. The immunoglobulin (IgG)
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Sflndhedsstyrelsen
Flemming Bo Andersen
SnebrerhegnetT4
2670 Greve
BILAG
20. december
2002
J.nr.0-303-02-36/1/SP
2. kontor
lslands
Brygge
67
Postboks
1881
2300Ksbenhavn
S
Tefefon
Direkte
Fax
E-post
722274OO
72227807
72227414
[email protected]
www.sst.dk
Vedr. Borreliadiagnostik i Danmark II
Som svar pfl Deres brev af 16.10.02og i forlengelse af vores telefonsamtale
kan jeg oplyse f6lgende:
Det er i Danmark StatensSerum Institut og de relevante kgevidenskabelige
selskaber,der har ansvaretfor at fplge den internationale udvikling vedr. borre-
liadiagnostik. StatensSerum Institut, der er et institut under sundhedsministe-
ren, er landets centrallaboratoriumfor si vidt angir human bakteriologi, viro-
logi og serologi. StatensSerum Institut driver videnskabelig forskning, ridgi-
ver og udfgrer kontrol og referencefunktionerpi disse omrflder herunder for
borreliadiagnostik som anfprt i Sundhedsstyrelsens
svar af 2. oktober 2002.
Efter Sundhedsstyrelsens
opfattelsevaretagerStatensSerum Institut denne
funktion pfl hgjt fagligt niveau herunderogsi vurderingen af internationale
forskningsresultater.StatensSerum Institut deltager i det internationale forsk-
ningssamarbejde
vedr. borreliadiagnostik og vurderer lpbende hvilke tests, der
kan anbefales.De eksisterende
testser ikke fuldt tilfredsstillende og forhibent-
ligfgrer dansk og international forskning til en udvikling af bedre borreliatests
over nogle ir.
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