This is rather a lengthy translation and perhaps not particularly good English in parts but certainly highlights our problems and some of the reasons why we have them.
If you have Fibromyalgia, ME/CFS, Polymayalgia Rheumatica, Arthritis or Neurological problems as I did, then do read on.
The Danish test for the disease Borrelia is very uncertain, says foreign experts. The doctor who has advised the Board of Health on using a particular Borrelia test at home, has developed it and make money on the sale - and he has not disclosed his conflict of interest
When we in Denmark should test for the disease Borrelia - a bacterium transmitted by ticks - doctors use the test called ELISA. It stands for clearly recommended in an article IngentaConnect from 2006, written by Chief Physician at Rigshospitalet - and leading borreliaekspert in Denmark - Klaus Hansen.
In the article writes Klaus Hansen, the ELISA test is preferable when the diagnosis of Borrelia necessities. The rival Western Blot he advises not to use. 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 is "irrelevant, " how much money it involved. Information learns that there be between 75,000 and 100,000 ELISA tests in Denmark every year and to Klaus Hansen's version of the test is about half the market. There are so sold up to 50,000 by Klaus Hansen ELISA year alone on the Danish market. Information has not been able to get the price of the test, but Statens Serum Institut is 590 kr. patient to make it.
Doctor's economic interests is not clear from either the articles 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 lucid example of disguised marketing. We are assessing the texts have not an earthly chance to deal with it, "says Inga Marie Lunde ..She particularly notes that Klaus Hansen has also written clarification report without giving any conflicts of interest:»Clarifiers report is indeed the one that underlies the Danish practice in this area - on which we all practitioners inform us after," says Inga Marie Lunde.
Also in Ugeskrift For Doctors believed that Klaus Hansen acted wrong:"He should have shown this interest in his article in Ugeskrift for Physicians," writes science editor, Jacob Rosenberg in a brief email to Information. Doubts about testELISA, as Klaus Hansen and his colleagues recommend is also uncertain, says several experts who have spoken to Information. They prefer typical Western Blot test, which Klaus Hansen fining the report advises against the use of.
Among these are medical and research director Nikolaus Ackermann from the renowned Max von Pettenkofer Institute, Ludwig Maximilians University in Munich:»Western Blot tests are 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.
Even the American doctor Daniel Cameron, leader of ILADS - International Lyme And Associated Diseases Society, an international, nonprofit, medical Borrelia organization. Daniel Cameron has worked with Borrelia in 23 years and believes that the Danish doctors oblique collateral to the ELISA test, patients come to evil:"Our frustrations with the ELISA test is that it gives too many fejldiagnosticering er. The Danish doctors rely on tests, and it is a mistake that ultimately goes beyond the fault diagnosed patient. Because if doctors get a negative response from the ELISA test, so start the no treatment of the infected patient, "says Daniel Cameron.
Consultant for the German private hospital for borreliabehandling, Borreliosis Centrum Ausburg, Karsten Nicolaus, believes that the ELISA test alone is useless to diagnose the disease:"ELISA tests are the cheapest - and it is the only incentive to use them as I see it. There is certainly no medical explanations for that user testing, and my suggestion is that you throw it away, "says Karsten Nicolaus. Also in the Statens Serum Institut believe Dr. Kari Mølbak that Western Blot is the best way to diagnose on.'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 Kari Mølbak.
Yet he believes that the Danish practice of using only the ELISA test, is fine:'ELISA test is cheaper and more convenient in a daily context, and for routine use, it will usually be fully sufficient, "says Kari Mølbak who emphasizes that he sticks to the recommendations of the Danish experts - meaning Klaus Hansen and the other authors for clarifying the 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 - and to get to know that you do not have the disease, even if you have it. The false-positive results are most common. Both are obviously dangerous - especially the false negative results which may lead to prolonged untreated illness. An untreated Lyme disease can cause severe paralysis and pain from the sick.
No evidenceKlaus Hansen denies that the Western Blot is the best way to diagnose at:"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 am not informed about it when we made the clarification report, "he said, adding:"In retrospect should have been that I had a relationship with the company concerned. But there was no ulterior motive behind it was not there. We thought about just not over it. "- How can you not think that even make money at it, you sit and recommend?
"You have to take my word that I have not thought about it. Today I can see that I should have done. And had anyone told me back in 2006, then I should have said 'yes, of course, should we write it', "says Klaus Hansen.
In fining the report is right now - in April 2010 was added to Klaus Hansen has a conflict of interest. Initially, wrote the group behind the report conflicts of interest in, without writing there was a new and updated version. Clarification report named so still '1. edition 2006 '. It is so in other words, as if the conflict of interest had always been included. Only when information again addressed, it will be entered, that there is a new version from April 2010. It was because the group behind the report a "bug, which has now been corrected.
Klaus Hansen wants despite several invitations not 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.
Borrelia infection, also known as Lyme Borreliosis, is a bacterium transmitted to humans by ticks, a blood-sucking mite.The first danger signals: A growing red spot around the place where the tick bed. The red stain is typically one to four weeks after the bite and the tick is usually gone. Spot becomes progressively larger and larger. Symptoms: fatigue, headache, mild fever and joint pain.
Exacerbations: Approximately one in ten develop so-called neuroborreliose (borreliosis of the nervous system). Symptoms often start with pain typically between the shoulder blades and neck. You may get nerve paralysis, most commonly of the facial nerves. Can also appear as meningitis (meningitis) .
Uncertainty about Danish Borrelia diagnoses
Many Danish patients consider that they have Lyme disease even though they repeatedly tested negative in the Danish test. They fail something else believes Danish experts. In Norway, you are more open to that patients have Lyme disease, although they tested negative
Many Danes believe themselves that they have Lyme disease, although they have been tested negative for the disease at home. But that information today can tell, is the Danish ELISA insecure, and hence we can not exclude that patients are actually sick. When the tests can give a so-called false negative results, due, among other things, that some people are very slow to form the antibodies to test for and therefore will be tested early. A penicillinkur early may mean that the antibodies are hard to find. Foreign researchers also believe that some people never form the antibodies, even if they are sick - but this is a controversial phenomenon - and most experts accept that it is possible. Among them is Dr. Klaus Hansen from Copenhagen University Hospital: "It is true that the test can give false negative results. But only in the first week of the disease. Within three months, all antibodies and therefore be tested positive with an ELISA test, if the infection is active and thus require treatment, "says Klaus Hansen, who is co-author of the Danish decanting report that underlie the Danish practice in this area . It is called the phenomenon of 'occult chronic Borrelia infections. "Klaus Hansen's interpretation is backed up by most of Borrelia-experts, but in eg Norway are beginning to have a more open attitude towards the possibility that you may have chronic Borrelia although it does not produce antibodies. In the Norwegian equivalent of the Danish clarification report that guides practitioners in the diagnosis and treatment of Lyme disease, it encourages an open attitude in this area.
The report provides further that there is much that medical science still does not know about Lyme disease, which doctors must have in mind - especially to those patients who might have a condition, "which later may prove to be overlooked by current health system . 'The report also recommends that you make a scientific study of the phenomenon. Stress or depression At Statens Serum Institut is Dr. Kari Mølbak one of the experts who relate open to the possibility and consequences of developments: "It may be that we in a few years will have a different view of Borrelia. The science is evolving and this is one of the questions that are not scientific consensus, "says Kari Mølbak. In Denmark it is the widespread perception that a negative ELISA test means that you have not Borrelia. Typically patients receive diagnoses stress, chronic fatigue syndrome or depression. Patients myself believe that it is because the ELISA test can not be used to identify their illness.
Patients feel they are faced with great arrogance in the Danish health system.
Information has also spoken with a number of Danes who have made a negative ELISA test in Denmark, but has since been found positive abroad when their own cost, have undergone a second type of test. Health Lawyer Karen Vanderhoof-Forschne r, founder of the Lyme Disease Foundation (Borrelia Fund), deals with many cases of misdiagnosis: "Fault Diagnosis and false negative tests may lead to persistent pain, blindness, dementia, disability - and these are the psychological consequences. Private one can lose his job, a wife or husband and being deprived of education or his social life, "she says.
Practitioner Claus Hancke is one of Danish doctors who send patients abroad to be investigated because he did not think we are good enough to make the diagnosis at home: "I have had many patients who tested negative in Denmark, and then you have closed the possibility of a treatment. But they may well be sick anyway, and we do not recognize. But the longer you go in the Danish system, the more you become incapacitated, the disease attacks the unyielding, "he says. Precisely therefore invites Claus Hancke his patients to be diagnosed abroad: "Many of my patients are tested positive abroad. And when they receive treatment with large amounts of intravenous antibiotics, they are immediately better, "says Claus Hancke.
But Klaus Hansen from Rigshospitalet believe it if necessary may be a placebo response that is to say that the patient feels that the medicine works, although in reality it has no power: "Placebo effect is an important factor when it comes to this kind of problem," says Klaus Hansen, referring to a study published in The New England Journal of Medicine in 2001. It is carried out among 129 patients who claimed to have Lyme disease but was antibody negative. Half got antibiotics and the other half received placebo, but 40 percent of both treatment groups were better. He also stresses that many of the foreign borreliaklinikker are private and make money on the patients: "It's not impossible to imagine that these clinics are interested in interpreting test results as positive. And it is very inappropriate. This results in the possibility of misdiagnosis, so you do not find the real disease - and an unreasonable over treatment for a suspected and in my view dubious Lyme disease, "says Klaus Hansen.
Claus Hancke believe that the clear rejection of that abroad can be better than in Denmark, is dangerous: "At home you do not let the possibility of Borrelia open, if the ELISA test is negative. In my opinion a mistake. And we do not believe that there can be no overseas are better than us. It would be good with a little humility, 'says Klaus Hanke.
CommentsChristian Frismodt says: Klaus Hansen unenlightened economic interests in a test involving the package insert says that it can not stand alone - and that some patients do not develop antibodies. Yet he maintains again and again that the test can stand alone - and that everyone develops antibodies before or since?! Several patients - and even doctors - have tried to illustrate that KH was on the wrong track regarding. ELISA test grades. But nobody has met professional curiosity - just a wall of defense (a right unlucky constellation when it is now published that KH receives royalties from the test, he blindly defends). An example: We have both U.S. and German video-recorded Spirochaete activity in patients who were positive with Immuno only test - and negative in the ELISA test. KH will not even watch these videos, because "you can not see the infection in the blood," he says. While he says: "We are working after all evidence-based" ! dear Klaus Hansen 1st infection can be seen in dark field microscopy in sufficient magnification. We can see Spirochaete activity - and the proportionality of the symptoms. This, coupled with immuno Blot, can identify which patients actually false negative! To see - and maybe learn - of filming, you have refused! (USAGE - and without basis). So you can actually keep the truth about Lyme full depth and breadth of life for years, when your views are narrow-minded, without professional curiosity and always protective of the ELISA test. 2nd In your own decanting report included an article describing the discovery of seronegative Borrelia for 10 year old skin changes (in the report manipulated this to be "acute skin lesion" instead. So it fits it's also more into the part - and to test). Uh, "evidence-based work," whom? You? Precisely this fact contradicts yours staunch assertion that all develop antibodies after max. 3 months!? 3.Du exclude evidence based research that has just mdsiger your claims and illustrate the ELISA weaknesses (Ex. Oksi JCM 1995, ... as found that> 50% late dyrkningsverificere de borreliosis pt, were seronegative, and Strle CID 2006, which found that> 70% late (> 6 months) dyrkningsverificere de NEURO-borreliosis caused by B. afzelii were seronegative . Do you work only evidence-based, when conclusions are to the benefit of your ELISA test?
Klaus Hansen, the consequence of your practice is that there are a large number of patients currently living with measly life with injuries from undiagnosed Lyme disease. Denmark need for new legislation (no economic interests of doctors in diagnostic tools. Especially not when they themselves simultaneously vejlleder on electoral test tool). And, Denmark needs, so, to revisit the Lyme diagnosis and treatment! Will our new Health Minister to make sure it qua the malpractices detected now?
3 May 2010, at. 02:11
Christian Frismodt says: It is also fantastic that Klaus Hansen, with his economic inflamed background, quotes the following: He also stresses that "many of the foreign borreliaklinikker are private and earn money from patients. It's not impossible to imagine that these clinics are interested in interpreting test results as positive. It's an almost divine lack of self-criticism, one must say! The new documentation, KH refers to come from doctors and researchers who have had the infection from close quarters (even in a family or circle) - and then vigorously sought the truth about Lyme disease - and THEN have opened clinics to help others searching for help! (For which help is available if diagnosed in time). But at home it is KH himself - and his students, who must respond to research on, for example. the weakness of its own tests. Who believes in incentives for this? - And thus a responsible and careful safeguarding of patients' interests?
Politicians rages over doctors 'forgotten conflicts'Information could yesterday reveal that the doctor who advises Danish physicians in the diagnosis of Borrelia even earn money on the test, he recommends. Politicians now want better oversight of doctors' conflicts of interest
Danish politicians want more transparency when doctors should recommend products to diagnose and treat diseases, such recommendations are not at the background of the individual physician's economic interest. Doctor Klaus Hansen is one of the doctors who advise all practitioners Danish doctors from using the ELISA test to diagnose the infection Borrelia. But what he forgot to say was that he even makes money on the test. It could INFORMATION yesterday show. Klaus Hansen advised the same time around Danish doctors to use the competing tests, Western Blot.In the so-called decanting report in which practitioners find information about treatment and diagnosis, there was until April 2010 is not abandoned, to Klaus Hansen himself has economic interests in the product.
Sophie Hæstorp Andersen, Health Committee of the Social Democrats believe that to be kept a watchful eye on the doctors' conflicts of interest:"There is probably a great many doctors who want to help with inventions and research and then take out a patent on them and thus have a conflict of interest. It is a natural consequence, but it is very problematic when it is notified to the public and practitioners, "says Sophie Hæstorp Andersen.
Must have consequences
Also, Jonas Dahl, who is health rapporteur for SF considers shameful example of the Danish health:"If doctors themselves can not figure out how to give up what is in accordance with the truth, so we must look at how to impose them a penalty. It is direct fraud. One possibility prospectively is to simply ignore the doctors here in Danish research, "says Jonas Dahl from SF.
SF will ask Health Minister's written questions in the proceedings"It is totally unacceptable that this can take place. We will beat SF very tough on it, as it ultimately may have important health implications for patients who do not get the best possible diagnosis, "says Jonas Dahl.
Danish People's Party health spokesman Liselott Blixt, will also further to the Information Ministry articles ask questions about the lack of transparency in the area:"I simply get so indignant about the fact that we constantly see overlap between medical recommendations and economic interests. For it goes beyond individuals, with the lack of transparency, "says Liselott Blixt from DF.S also believes that the example should trigger a debate in this area"It is beneath contempt - we'll have to ask the Board of Health on how it can go to Klaus Hansen did not record those interests here. If they sit there and sleep in hours, it is very problematic, "says Sophie Hæstorp Andersen, who nevertheless believes that the ultimate responsibility in this area rests with the health minister.
The Liberal Party's health spokesman Birgitte Josefsen, disagree in. She shoots the ball forward to the Board of Health, which she believes holds the ultimate responsibility:"It is a matter which the Board of Health must take care of. There are very strict rules that doctors must disclose their conflicts of interest. Therefore, they must intervene in this matter, "says Birgitte Josefsen.
-Has the Minister and the Government is not the ultimate responsibility in this area?"It is absolutely sovereign Board of Health's commitment. It is not the minister, because it is a technical agency, and this is a technical discussion. The rules are crystal clear - we're all about the National Board of Health must up a gear, "she says.
Vivi Kier from the Conservative opposition is just as concerned about the overlap between economic interests and recommendations, but generally confident that Denmark leads a sensible practices:"I will still ask the Ministry of Health, why we use the test here in Denmark. Whether it is because of price, or what it is about, "says Vivi Kier from Conservatives.
Like the S, SF, and DF Conservatives will not yet do anything about the situation than to ask the Department questions.
Health Protection Agency does not wish to participate in this article as decanting the report was released for IngentaConnect and not at their level. According to the Health Protection Agency itself, Klaus Hansen used not as an expert and therefore the Board did not consider his legal capacity problems.
Fact: The case brief
The Danish physician Klaus Hansen, Denmark's leading borreliaekspert, in collaboration with a handful of other doctors prepared a guidance paper for the diagnosis and treatment of Lyme back in 2006. In this regard, said Klaus Hansen, that he even makes money on the test, the ELISA test, he recommends Danish doctors to use.
Information has been in contact with a number of foreign experts, who recommend the competing Western Blot test, which they consider more accurate diagnoses. Klaus Hansen advises in the report back in 2006 Danish physicians to use this particular test.
To read the entire Information coverage of the story go to http://www.information.dk/231920
'No one in Denmark believed in me'Sadet Daniels was in 2006 diagnosed with stress - in fact she had Lyme disease, but the Danish test was negative. In Germany, she found Borrelia, but even if she had a positive test in hand, would the Danish doctors did not recognize her disease and she had to pay for treatment. Today she is well Sadet Daniels paid a high price both medical and economical for poor Danish Borrelia Diagnosis: 'I was even diagnosed by going to Germany, and I even paid £ 35,000 for my treatment there. It has many not allow. Most would probably rely on what their doctor says. It was only because I fought against the system - and indeed the money for treatment - that today I am in good health, 'says Sadet Daniels. Easter morning in 2006 woke up Sadet Daniels with pain throughout the body and one arm felt "heavy and dead '. Shortly after she was hospitalized at Bispebjerg Hospital where she underwent several tests. Doctors could not figure out what she failed, and she was subsequently diagnosed with stress. In fact, she had Lyme disease, and doctors also found that she had all the symptoms - also fit it with the fact that she had been bitten by a tick on a holiday in France a few months earlier. But the so-called ELISA test, which you use in Denmark, gave a negative result and therefore excluded the possibility doctors: "I was told that when the test was negative, it could not be Lyme. So I'm obviously on, "says Sadet Daniels.
Over the next two years, her condition got worse and worse. She went to a psychologist for his stress: "I was recommended to take antidepressant medication. This I refused. But after two years gave me after. It helped, of course not least, "says Sadet Daniels. She has her husband and children - and work at the time as a stewardess in SAS. But Sadet Daniels might soon ill join because the disease had begun to take real hard on her: Was as stunned "It was terrible. It felt as though I had tight rubber bands on arms and legs. I had big stains on the back, where I could not feel anything, even if you stuck a needle in. And left side of my face was completely stunned, "she says.
A late night hours at the computer took Sadet Daniels realized that the ELISA test can give false negative results - so that you can have Lyme disease, although the test is negative. Since there was no help from the Danish doctors, she went to a German private hospital that specializes in Lyme. This user Mon several tests, including the so-called Western Blot test. It was positive. Yet she could not get treatment in Denmark: Rescued by German hospital 'The Danish doctors did not believe that I had Lyme disease, even though I had a positive test from Germany. 'The test is not approved in Denmark', they said. So they would not give me any treatment.
In general, doctors in Denmark was very arrogant. They talked to me as if I did not understand something - and my doctor at Bispebjerg flatly rejected the possibility that the German tests were correct, "says Sadet Daniels. Therefore, paid herself 35,000 dollars to be treated with large amounts of antibiotics in the German private hospital: "There was a completely different mood in Germany. For the first time in the entire process I felt that one took me seriously. And the treatment was extremely effective. It is the best money I ever spent in my life. I dare not even think about what had happened if I had not come into treatment, "says Sadet Daniels, who is now almost well again. "I have always been in good shape and trained a lot and I feel that my muscles will never be as they once were. But I have full feeling in the body, and the genes I have today is nothing compared to how I felt when I was sick. "
Since Sadet Daniels had gotten over his Lyme disease, she contacted the Danish doctors and told them that she was healthy: "I thought that now would you then listen to me, but they still denied that I had been sick. If treatment with antibiotics had worked, it had to be psychosomatic, said my doctor at Bispebjerg. Because I had not Borrelia when I was tested negative. " The combination of the arrogant Danish attitude and lack of knowledge about the disease and diagnosing it is very dangerous, consider Sadet Daniels: "They trust blindly in test results, but you must not - so by the U.S. and Germany '. And it is according Sadet Daniels only because she was stubborn, she is now healthy: "It was myself who found out that the Danish test is unreliable. I was even diagnosed, and I found and paid even for my treatment. There are many who do not have the opportunity. Most would probably rely on what their doctor says. It was only because I had the strength to fight the system - and indeed the money for treatment - that today I am in good health. "
Information submitted Sadet Daniels' history of the Danish Borrelia expert Klaus Hansen, but he would not comment on a specific patient case. He says, however, that when we in Denmark have not always rely on foreign test results, it is because they are performed in private hospitals and earn money on treating a patient - and who therefore have an economic interest in having many positive results.