Private economic interests behind Danish Borrelia diagnostic test
Written by: Kristian Villesen, Sofie Tholen (original source in danish: http://www.information.dk/231920)The Danish test for the disease Borrelia is very uncertain,
says foreign experts. The doctor who as advised the Board of Health to use
a particular Borrelia test in Denmark has developed it and earns money
on the sale - and he has not
disclosed his conflict of interest.
When
doctors in Denmark test for the disease caused by Borrelia - a bacterium
transmitted by ticks - they use an ELISA test. The test is clearly
recommended in an article in IngentaConnect from 2006, written by Chief
Physician at Rigshospitalet - and leading borrelia expert in Denmark -
Klaus Hansen.
In the article, Klaus Hansen writes that the ELISA test
is preferable to make a diagnosis of Borrelia. He advises against using the
rival Western Blot test. A similar conclusion appears in the
clarification report from 2006, which underlies the Board of Health
recommendations.
The report has Klaus Hansen as co-author. Klaus Hansen
has even developed the version of the ELISA test that is most widespread in
Denmark - and he makes money on sales.
According to Klaus Hansen, how
much money it involved is "irrelevant" . Information has learned that
there are between 75,000 and 100,000 ELISA tests in Denmark every year and
about half the market uses Klaus Hansen's version of the
test. Up to
50,000 of Klaus Hansen's ELISA tests are sold every year on the Danish
market.
Information has not been able to get the price of the test, but
Statens Serum Institut charges 590 kr. patient to carry it out.
The
doctor's economic interest is not clear from either the article or
clarification report from 2006.
"It is a clear example of the
problems that arise when doctors have conflicts of interest," says Inga
Marie Lunde from Doctors Without Sponsor, a network of physicians that
promotes independence from commercial interests:
"It is a clear
example of disguised marketing. We are assessing the data so that we can
deal with it," says Inga Marie Lunde.
She particularly notes that
Klaus Hansen has also written a clarification report without revealing
any conflicts of interest:
"The clarification report is indeed the
one that underlies the Danish practice in this area - which all
practitioners follow," says Inga Marie Lunde.
Also Weekly News For
Doctors believed that Klaus Hansen acted wrong:
"He should have declared
this conflict of interest in his article in Weekly News for Doctors,"
writes Scientific Editor, Jacob Rosenberg in a brief email to
Information.
Doubts about test
The ELISA that Klaus Hansen and his
colleagues recommend is unreliable, says several experts who have spoken
to Information. They prefer typical Western Blot test, which Klaus Hansen
advises against using.
Among these are medical and research director
Nikolaus Ackermann from the renowned Max von Pettenkofer Institute,
Ludwig Maximilians University in Munich:
"Western Blot test is
clearly better than the ELISA test. It is more precise. It has been
recognized in Germany, where it becomes more and more common to use the
Western Blot. The optimum is to use both tests, so you can compare the
results, "says Dr. Nikolaus Ackermann.
The American doctor Daniel
Cameron, leader of ILADS - International Lyme And Associated Diseases
Society, an international, nonprofit, medical Borrelia organization, agrees.
Daniel Cameron has worked with Borrelia for 23 years and
believe that
Danish doctors reliance on the ELISA test harms patients:
"Our
frustration with the ELISA test is that it gives too many false-negative
results. The Danish doctors rely on these tests, and it is a mistake
that ultimately goes beyond the bad test. Because if doctors get a
negative result from ELISA test,
they fail to initiate treatment of the
infected patient, "says Daniel Cameron.
Consultant for the German
private hospital for borrelia treatment, Borreliosis Centrum Ausburg,
Karsten Nicolaus, believes that the ELISA test alone is useless to
diagnose the disease:
"The ELISA test is the cheapest, which is the
only incentive to use the test as I see it. There is certainly no
medical reason for relying on that test, and my suggestion is that you throw
it away," says Karsten Nicolaus. Also in the Statens Serum Institut
believe Dr. Kaare Mølbak that Western Blot is the best way to
diagnose.
'The great strength of the Western Blot is that it can
exclude other bacteria that resembles Borrelia. "
- Which Lyme test
is best?
"The Western Blot," says Kaare Mølbak.
Yet he believes
that the Danish practice of using only the ELISA test is fine: 'ELISA
test is cheaper and more practical in an everyday context, and for routine
use, it will usually be fully sufficient," says Kaare Mølbak who stresses
that he follows the recommendations of the Danish experts - meaning Klaus
Hansen and the other authors of the clarification report.
"ELISA tests
can give both false positive and false negative results. This means that one
can learn that you have the disease without it - or think that you do
not have the disease, even if you have it. The false-positive results are
more common. Both are obviously dangerous - especially the false
negative results which may lead to prolonged untreated illness. An untreated
Borrelia disease can cause severe paralysis and pain from the
illness.
No evidence
Klaus Hansen denies that the Western Blot is
the best way to diagnose Borrelia:
"In our industry we are so
evidence-based. And there is no evidence that Western Blot is better,"
says Klaus Hansen.
Regarding conflicts of interest Klaus Hansen admits
that he erred:
"It's true. And I can only regret that I was not
informed about it when we made the clarification report," he said,
adding:
"In retrospect I should have said that I had a relationship
with the company concerned. But there was no ulterior motive behind not
saying it. We just didn't think about it. "
- How can you not think
about making money from the test, if you recommend it?
"You have to take
my word that I have not thought about it. Today I can see what I should have
done. And had anyone told me back in 2006, then I should have said 'yes,
of course, we should write it', "says Klaus Hansen.
In appears that
the report has been corrected - in April 2010 an update was added that Klaus
Hansen has a conflict of interest. The group behind the report noted the
conflict of interest without writing there was a new and updated
version. The clarification report is still called '1st edition 2006
', as if the conflict of interest had always been indicated. Only
when information again addressed the issue, we were told that
there is a new version from April 2010.
The group behind the report explained that there
was a "bug", which has now been corrected.
Despite several
invitations, Klaus Hansen refuses to say how much money he earns on the sale
of the ELISA tests.
"It does not matter. And this is my last word on
the matter, "says Klaus Hansen.
In another article by the same two journalists from Information title translated:
UNCERTAINTY ABOUT THE DANISH DIAGNOSIS OF BORRELIOSIS
(original source in danish http://www.information.dk/231899)
"It is true, that the test may give false negative result. But only in the first weeks of the illness. At latest 3 months (after symptom debut) every patient vill form antibodies and therefore be tested positive with an ELISA test, if the infection is active and therefore necessary to treat" says Klaus Hansen, which is co-author of the danish clearing report, which underlies the common practice in this matter.
1. 5y boy. July 1985 EM. Aug 1985 Lymphocytic meningitis. Seropositive for IgG and IgM, no antibodies in CSF. Penicillin V orally 100000 u/kg/d, 14d. [oral penicillin does not penetrate into CSF well in sufficient concentration, therefore it is not dommed appropiate to treat neuroborreliosis with oral penicillin!] Spinal-fluid showed fewer cells. September 1985 facial palsy, again pleocytosis in CSF. Doxyc. orally 2mg/kg, 10d. [In the USA the recommended dose of doxycyclin to children > 8 years is 4 mg/kg/die; doxycycline is NOT recommended to children under 8 years of age!]. Gradually CFS normalized. April 1986 relapse (7 months after treatment), Bb was isolated from CSF after 4 weeks in BSK-medium. Penicillin 200000 u/kg, 22d. August 1986 relapse/reinfection with EM and painful meningoradiculitis, Bb antibodies now negative in CFS and serum. Culture not done!
2. 49y man. EM, typical signs of LMR-Bannwarth S developed 7 weeks later. Pleocytosis and elevated protein in CSF. Both Borrelia IgM and IgG positive in serum. Penicillin i.v. 20 MU/d, 10d. Four days after therapy normal examination and no complaints, CSF declining parameters, positive Borrelia-index. Three months later CSF normal, Borrelia-index now negative, but Bb was cultured from CSF!
3.
26y
woman. Headache, radicular pain.
Normal
neurological exam. Multiple horseflie bites. CSF
pleocytosis and elevated protein.
Negative
Borrelia-ELISA in CSF and
serum.
Ceftriaxone i.v. 2g/d ,
10d. Improved.
7.5 month later recurrent episodes of radicular pain, headache,
arthralgia,
fever. Normal neurological exam.
Negative
serology. Normal CSF. Bb cultured
from CFS after 6 weeks in MKP-medium.
Cefotaxime
3 x
2g/d i.v., 14d.