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The Financial Implications of a Well-Hidden and Ignored Chronic Lyme Disease Pandemic

Posted By: CrystalRiver
Date: Wednesday, 12-Sep-2018 08:45:50

The Financial Implications of a Well-Hidden and Ignored Chronic Lyme Disease Pandemic

Marcus Davidsson
Author information ► Article notes ► Copyright and License information ► Disclaimer
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Abstract
1 million people are predicted to get infected with Lyme disease in the USA in 2018. Given the same incidence rate of Lyme disease in Europe as in the USA, then 2.4 million people will get infected with Lyme disease in Europe in 2018. In the USA by 2050, 55.7 million people (12% of the population) will have been infected with Lyme disease. In Europe by 2050, 134.9 million people (17% of the population) will have been infected with Lyme disease. Most of these infections will, unfortunately, become chronic. The estimated treatment cost for acute and chronic Lyme disease for 2018 for the USA is somewhere between 4.8 billion USD and 9.6 billion USD and for Europe somewhere between 10.1 billion EUR and 20.1 billion EUR. If governments do not finance IV treatment with antibiotics for chronic Lyme disease, then the estimated government cost for chronic Lyme disease for 2018 for the USA is 10.1 billion USD and in Europe 20.1 billion EUR. If governments in the USA and Europe want to minimize future costs and maximize future revenues, then they should pay for IV antibiotic treatment up to a year even if the estimated cure rate is as low as 25%. The cost for governments of having chronic Lyme patients sick in perpetuity is very large.

Keywords: Borrelia, Lyme disease, chronic Lyme disease, ILADS, incidence rate, cost chronic Lyme disease, CDC
Go to:
1. Introduction
The objectives of this article are to investigate the incidence rate of Lyme disease in the USA and Europe, to investigate the financial cost of chronic Lyme disease and to find the most cost-efficient way for the governments to solve the current chronic Lyme disease pandemic [1]. Very few studies exist that calculate the economic impact of chronic Lyme disease [2]. According to the European Centre for Disease Prevention and Control (ECDC), Lyme disease—also known as Borreliosis—is caused by a spirochete bacteria called Borrelia burgdorferi [3]. An early stage Borrelia infection is known as acute Lyme disease and a late stage Borrelia infection is known as chronic Lyme disease. A Lyme disease “war” has been going for a long time [4,5] between two doctors’ associations regarding the most appropriate way to diagnose and treat Lyme disease. The two doctors associations are the Infectious Diseases Society of America (IDSA) [6] and International Lyme and Associated Diseases Society (ILADS) [7]. IDSA represents infectious disease doctors that firmly believe that all Lyme disease infections, regardless of whether the infection is acute or chronic, can successfully and easily be treated with three weeks of oral antibiotic [8] despite the fact that no scientific studies currently exist that support the claim that three weeks of oral antibiotics can always cure acute or chronic Lyme disease [9] and there exist many scientific studies that have shown that the Borrelia bacteria can survive three weeks of oral antibiotics in vitro [10,11] and in vivo, in mice [12,13,14,15], dogs [16], horses [17], monkeys [18] and in humans [19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36]. The in vivo references have mostly been extracted from [37,38,39]. Alive Borrelia bacteria has been found in 7 out of 8 patients with chronic Lyme disease [40]. The immune system by itself can never eradicate a Borrelia infection [41,42,43,44] and no scientific studies exist that show that bacterial infections can simply disappear. Approximately 63% [45,46] of people today that are infected with Borrelia, unfortunately, develop chronic Lyme disease. Most Lyme disease patients today either do not receive any antibiotic treatment at all or they receive an insufficient amount of antibiotic treatment. The IDSA does not recognize chronic Lyme disease, nor do they recommend antibiotic treatment for chronic Lyme disease. The IDSA calls chronic Lyme disease post-treatment Lyme disease syndrome (PTLDS) [47] but it has been suggested that this term is a misnomer and should not be used [48]. Because chronic Lyme disease is classified as a syndrome instead of an infection, the IDSA therefore does not recommend antibiotic treatment for chronic Lyme disease.

In 2006, the IDSA treatment guidelines development process was subjected to an antitrust investigation by the Connecticut Attorney General [49], which found that many IDSA treatment panel members had conflicts of interest [50]. In November 2017, another antitrust lawsuit (Civil Action No 17-cv-190) [51,52] was directed at the IDSA along with several large insurance companies in the USA and several IDSA medical doctors, in a federal court in Texarkana, Texas in the USA. The allegations concern violations of the Racketeer Influenced and Corrupt Organizations (RICO) Act and the Sherman Antitrust Act. According to the Agency for Healthcare Research and Quality (AHRQ), which is part of the U.S. Department of Health and Human Services, 86% of health care costs in 2010 in the USA came from patients with one or more chronic conditions [53]. The concern is that because Intravenous (IV) antibiotic treatment for people with chronic Lyme disease costs so much money, insurance companies in the USA may gain by colluding with the IDSA to ensure chronic Lyme disease is not classified as a real disease caused by bacteria, so that IV antibiotic treatment can be denied.

The scientific process fails if it can be controlled by a group or groups with a particular agenda [54]. The IDSA’s treatment guidelines for Lyme disease are problematic in the following ways: (A) They do not follow The National Academies of Sciences, Engineering and Medicine recommendations on how to develop treatment guidelines [55] because the IDSA treatment guideline panel did not consist of a diversified and balanced group of doctors nor did the panel include patient representatives; (B) More than 50% of IDSAs treatment guidelines are based only on “expert opinion” [56]; (C) The IDSA’s treatment guidelines for Lyme disease do reflect the fact that, according to the CDC, Lyme disease can lead to death if not treated with antibiotics [57]. The CDC has, however, significantly underestimated the number of deaths caused by chronic Lyme disease. One study estimates that chronic Lyme disease and associated diseases could be the cause of over 1200 suicides per year in the USA [58].

The International Lyme and Associated Diseases Society (ILADS) represents Lyme Literate Medical Doctors (LLMDs) from around the world who recognize that chronic Lyme disease is a real and serious disease that must be treated with long-term antibiotics [59]. ILADS’ treatment guidelines for Lyme disease can be found on the National Guidelines Clearinghouse (NGC) web page [60]. According to ILADS, Lyme disease is a clinical diagnosis that is based on the symptoms a patient presents. LLMDs prefer to treat chronic Lyme disease patients with IV antibiotics because IV antibiotics are more effective than oral antibiotics [61]. However, oral antibiotics are much easier to administer, and they are not as expensive as IV antibiotics. Hence, in a situation where a patient cannot afford IV antibiotics, or if a patient has difficulties finding someone to administer IV antibiotics, then oral antibiotics are always preferred over no antibiotics. LLMDs can, if necessary, treat a patient with chronic Lyme disease with oral antibiotics for the rest of the patient’s life. Thus, similarities exist between chronic Lyme disease and the Human Immunodeficiency Virus (HIV) that also cannot be eradicated with oral medication.

Up until December 2017, the Centers for Disease Control and Prevention (CDC) in the USA officially endorsed the IDSA treatment guidelines for Lyme disease. What the CDC’s view on treatment for chronic Lyme disease is today is unclear [62]. The CDC still uses the IDSA terminology ‘post-treatment Lyme disease syndrome’ (PTLDS) [63]. It is unlikely that the IDSA’s lack of medical ethics when it comes to Lyme disease [64] was the reason why the CDC stopped officially endorsing IDSA treatment guidelines for Lyme disease, because in 2016 an anonymous whistleblower group of scientists from within the CDC, calling themselves CDC Scientists Preserving Integrity, Diligence and Ethics in Research (CDC SPIDER), raised concerns about the CDC’s lack of independence and ethics [65], stating, “We are a group of scientists at CDC that are very concerned about the current state of ethics at our agency. It appears that our mission is being influenced and shaped by outside parties and rogue interests”. The CDC therefore most likely stopped endorsing the IDSA treatment guidelines because legal and public pressure was building up. Today people are becoming more aware of chronic Lyme disease. The conflict over what the best ways are to diagnose and treat Lyme disease have gone so far that a Tick-Borne Disease Working Group was created when the 21st-century cures act became law in the USA in December 2016 [66]. The objective of the working group is to review the scientific literature, regarding for example causes, prevention, diagnosis, duration, surveillance and treatment for Lyme disease and associated diseases.

The genus Borrelia was named in honor of the French bacteriologist Amédée Borrel in 1907 [67]. The name Lyme comes from the name of the town in Connecticut in the USA where the disease was ”first” observed in 1977 [68] this despite the fact that the German physician Alfred Buchwald published the first case of atrophy of the skin already in 1883 [69]. In 1902 Herxheimer and Hartmann named such atrophy of the skin Acrodermatitis Chronica Atrophicans (ACA) [70] which is why ACA, which is dermatological disorder mostly associated with chronic Lyme disease in Europe [71], sometimes is called Herxheimer disease. ACA presents its self as a red-bluish discoloration of the extremities [72]. The link between Lyme disease and the bacteria that cause it was first discovered by the medical entomologist Dr. Willy Burgdorfer in 1982 [73]. The bacteria, therefore, took the name after its discoverer Borrelia Burgdorferi. It was first in 1929 when the serendipitous discovery of penicillin was made by scientist Alexander Fleming [74] that treatment for Lyme disease became available. Penicillin was originally produced from mold. Naturally occurring antibiotics can also be produced by fermentation, an old technique that can be traced back almost 8000 years [75]. The genes that convey antibiotic resistance to bacteria have been around for at least 30,000 years [76], which means that antibiotic resistance to a large part has not been developed during the last 88 years humankind has known about antibiotics which is a fact that we rarely hear about though.

One of the first people to treat chronic Lyme, or more specifically ACA, with penicillin in 1949 was Nils Thyresson [77] who was a Swedish medical doctor and professor of Dermatology and Venereology. The first human believed to have been infected with Lyme disease was Ötzi the Iceman [78]. This 5300 years old naturally preserved mummy was discovered in 1991 in the Ötztal Alps on the border between Austria and Italy. Spirochete bacteria are believed to be much older this though. Spirochetes similar to Borrelia has been found in a 15 million years old tick preserved in amber in the Dominican Republic [79] which means that the spirochete bacteria that causes Lyme disease is much older than humankind. The complete Borrelia genome was first sequenced in 1997 [80]. The Borrelia bacteria has the most complex genomic architecture among known prokaryotes [81]. Borrelia bacteria are also very genetically diversified [82,83]. Different Borrelia strains have different antigens [84] which means that different Borrelia strains will produce different immune system responses in the form of antibodies in an infected host. A blood test that only test for one specific antibody cannot detect antibodies from different Borrelia strains. A person that is infected with one type of Borrelia strain will also have different symptoms compared to a person that is infected with a different Borrelia strain [85]. For example, arthritis is usually not seen in European Lyme disease patients [86] due to the different Borrelia strains that exist in Europe compared to the USA which means that the lack of arthritis in a patient should not be interpreted as the patient not having Lyme disease. Lyme disease diagnosis and treatment are further complicated by the fact that Borrelia also has many different co-infections [87] such as Babesia, Bartonella, Ehrlichia, etc. It is believed that a vector such as a tick can spread at least 237 different types of bacteria [88] and many types of viruses [89] which means that many chronic Lyme patients might be infected with many different types of microbes at the same time.

In the Lyme disease documentary Under Our Skin, Dr. Burgdorfer says: “The controversy in the Lyme disease research is a shameful affair and I say this because the whole thing is politically tainted. Money goes to the same people who have for the last thirty years produced the same thing. Nothing”. [90]. The Borrelia bacteria has at least three different morphological forms. (1) A spirochete form [91]. (2) A round body form that is also known as cyst form [92]. (3) A biofilm form [93]. The Borrelia bacteria evade the immune system by for example changing morphology [94] and by changing its outer surface proteins (Osp) also known as antigens [95,96,97,98]. When the bacteria change its antigens all the time, the specific antibodies that are produced by the immune system to try to eradicate the infection becomes useless. The DNA structure that is believed to be responsible for the bacteria’s antigenic variation ability is called G-quadruplex (G4) [99]. Immune system evasion by other diseases such as Amyotrophic Lateral Sclerosis (ALS) [100] and cancer [101] is also believed to be connected to G4. Exciting research is being done that is trying to find medications that block G4 for the Borrelia bacteria [102]. If the researchers are successful, it could mean an end to chronic Lyme disease but also to other diseases. If the immune system in combination with some drug could eradicate the Borrelia bacteria that would be a superior solution compared to a possible lifetime of oral antibiotics. The bacteria evade being killed by broad-spectrum antibiotics by changing morphology [103]. Note that the bacteria ability to evade broad-spectrum antibiotics should not be interpreted as antibiotic resistant. Metronidazole/Tinidazole forces the bacteria to take a spirochete form [104,105] where other broad-spectrum antibiotics such as Azithromycin can kill it off. When chronic Lyme patients are treated with a macrolide antibiotic such as Azithromycin in combination with Metronidazole/Tinidazole, then the physician can also give Plaquenil which is an anti-malaria medication. Plaquenil raises the PH level in cells so that macrolide antibiotics can work more effectively [106]. Unfortunately, Plaquenil does not work for tetracycline antibiotics [107]. It is, however, important to note that Plaquenil can cause eye problems [108] which means that not all patients can tolerate this medication.

Because different combinations of antibiotics have different effects on the different morphological forms of the Borrelia bacteria [109], ILADS treatment guidelines recommend combination therapy with two different types antibiotics for chronic Lyme disease [110] for example metronidazole/tinidazole in combination with azithromycin/doxycycline. The recommended treatment for chronic Lyme disease is therefore different from the recommended treatment for acute Lyme by the IDSA which is, monotherapy with one antibiotic for example doxycycline. Again, similarities exist between HIV and chronic Lyme disease because both are treated with combination therapy. The reason for combination therapy for HIV and chronic Lyme disease is however different. Combination therapy in HIV is motivated by the fact that the virus develops resistance to the medication if you only treat with one antiviral medication. For chronic Lyme disease, this is not the cases. Combination therapy for chronic Lyme disease is motivated by the fact that the Borrelia bacteria changes morphology which means that monotherapy is not an effective treatment for Lyme disease.

A common mistake is to describe the symptoms of Lyme disease as “flu-like”. A serious Lyme disease infection should not be reduced to a simple cold. A better screening symptom for Lyme disease is paresthesia. Paresthesia manifests itself as vibrating sensation under the skin. One study estimates that 53% of patients with chronic Lyme disease develop paresthesia [111]. A second study estimates that 70% of patients with chronic Lyme disease develop paresthesia [112]. The good thing is that the paresthesia stops when antibiotics have killed off the infection [113] but also during treatment with antibiotics such as Metronidazole or Tinidazole. There are three main questions that need to be answered to justify treatment for chronic Lyme disease. (1) Do chronic Lyme disease patients without treatment suffer from a low Quality of Life (QOL) than the general population? Four National Institute of Health (NIH) studies have shown that the answer to that question is yes [114]. (2) Are the symptoms of chronic Lyme disease patients reduced because of antibiotic treatment? The answer to that question is yes [115,116,117,118,119]. (3) Can an untreated chronic Lyme disease lead to premature death? The answer to that question is yes according to our previous CDC reference. There exist a few studies that show that the symptoms of chronic Lyme patients do not improve with antibiotics treatment. There exist at least two problems with these studies. (1) They usually treat chronic Lyme patients with monotherapy which again is not a recommended treatment. (2) They have used flawed statistical methods [120]. Medical doctors should be able to use their professional expertise and in consultation with their patients determine the most appropriate treatment for patients.

A European study [121] estimates the sensitivity of the Lyme disease test to 44%. Such number was found by analyzing the performance of eight different Lyme disease tests. 89 different blood samples were tested for each test manufacturer. The sample also included healthy controls. Another study [122] that conducted a meta-analysis of the American scientific literature (eight scientific articles) regarding the performance of the Lyme disease test estimates the sensitivity of the Lyme disease test to 46% and the specificity to 99%. Because the blood tests that are used today by government health agencies to detect the human body’s production of antibodies against the Borrelia bacteria’s antigens are so insensitive Lyme disease, today must be defined as a clinical diagnosis as correctly advocated by ILADS. If a patient has had a blood test that suggests a Lyme disease infection that is fine, but a positive blood test should not be a requirement for a diagnosis. A person that suspect a Lyme disease infection is today, unfortunately, better of tossing a coin and diagnosing themselves because the blood tests for Lyme disease today will miss most infections. Specific antibodies often cannot be found in patients with Lyme disease because of the bacteria ability to shift its antigens.

Testing cerebrospinal fluid instead of blood will not improve test sensitivity because the bacteria can still shift its antigens in cerebrospinal fluid which means that the probability of detecting specific antibodies in cerebrospinal fluid is not larger than in blood. Moreover, cerebrospinal fluid causes the bacteria to change its morphology from a spirochete form to a cyst from [123]. If you only diagnose Lyme disease in patients that have specific antibodies in their blood or cerebrospinal fluid, you will miss most cases. To better understand Lyme disease testing let’s look at the confusion matrix [124]. All calculations can be found in the macro-enabled excel file “Lyme disease model.xlsm”. We assume in Table 1 that the number of people in the disease and control groups are known and equal. In real life, however, we do not know the number of people in the disease and control group. We can only observe the total number of people that tested positive in both groups.

More at this link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5872223/

--------------------------------

Many Blessings,
CrystalRiver





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