Jun 09 2009

Chronic Lyme Disease

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Comments: 14

Yesterday I wrote about a bill that has recently passed the CT state House and Senate that will exempt physicians who prescribe antibiotics for chronic Lyme disease (CLD) from being held to the standard of care. In my opinion this bill (likely soon to be law) represents an arrogant and counterproductive intrusion by the legislature into a complex area of medicine.

This bill is not an isolated case. There is already a similar law in Rhode Island, and there have been similar bills proposed in Pennsylvania, Massachusetts, and New York, and a bill in Maryland that would compel insurance companies to pay for antibiotic treatment for CLD.   This is part of a coordinated effort by individuals and organizations who hold an ideological opinion regarding the cause and treatment of CLD. They wish to use the political process to win a victory for their view that they have been unable to win in the arena of science (sound familiar).

Today I will summarize the current scientific and medical issues surrounding the concept of CLD, which in my opinion will highlight the folly of trying to capture this complex and rapidly evolving scientific question with a snapshot of political opinion.

The problem begins with the fact that Chronic Lyme Disease is not a discrete entity. The term has been used to refer to at least four different clinical situations, as outlined by Adriana Marques in her recent review:

Category 1 – symptoms of unknown cause, with no evidence of Borrelia burgdorferi infection
Category 2 – a well-defined illness unrelated to B. burgdorferi infection
Category 3 – symptoms of unknown cause, with antibodies against B. burgdorferi but no history of objective clinical findings that are consistent with Lyme disease
Category 4 – post-Lyme disease syndrome

In all of these types of cases there are patients who believe they are chronically infected with the Lyme spirochete, but they do not meet proven and accepted criteria for such a diagnosis. But it increases confusion to lump all four categories together, as the CT bill does.

What is not controversial is that Lyme disease is a tick-born infection with the spirochete bacteria Borrelia burgdorferi (in the US, while two other Borrelia species are common in Europe). The infection has an early  phase, characterized by a rash, often referred to as a targeted rash called erythema migrans, as well as fever, headache, and fatigue.There is also a late phase with arthritis, carditis (inflammation of the heart), and meningoencephalitis (inflammation of the brain and meninges). A common manifestation of the latter is Bell’s Palsy or facial weakness.

It is also not controversial that the spirochete usually responds to antibiotics. Rapid treatment in the early phase with doxycycline or other antibiotics know to be active against B. burgdorferi usually prevents development of late stage symptoms, and the late stage can also be treated, although usually IV antibiotics, such as ceftriaxone need to be used for 4-6 weeks.

The controversy lies with those who believe they have chronic infection with Lyme spirochetes despite adequate antibiotic therapy, or who never had clear evidence of Lyme infection in the first place.

The current consensus of scientific opinion on this matter is reflected by two recent reviews, that of Marques cited above and another by Phillip Baker:

Marques concludes:

At this point, the overwhelming evidence shows that prolonged antibiotic therapy, as tested in the clinical trials, does not offer lasting or substantive benefit in treating patients who have post-Lyme disease syndrome. Therefore, it is time to move forward to test other approaches that may help these patients. Unfortunately, no prospective studies of other treatment modalitiesfor patients who have post-Lyme disease syndrome have been performed.

And Baker:

The results of NIH-supported studies acknowledge that some patients with “chronic Lyme  disease/ posttreatment Lyme disease syndrome” indeed have deficits with respect to their physical health status. No doubt such patients experience significant pain and therefore require appropriate medical attention and care. However, because there is no evidence to indicate that their symptoms are caused by a persistent Borrelia burgdorferi infection, other options must be considered to determine their cause and how such patients might be treated to relieve their symptoms. Without direct evidence for a persistent infection, it is clear that extended antibiotic therapy is not the answer; it remains an unproven and unsafe therapeutic approach that is neither justified nor in the best interest of the public health. This is in accord with the views expressed by many outstanding experts in infectious disease.

To summarize these points, and emphasize my own experience and interpretation – at present there is insufficient evidence to support the conclusion that patients in any of the four categories above have chronic Lyme infection. The clinical evidence that we have for category 4 – CLD, is, on the balance, negative. There are significant risks to using long term antibiotics, and these risks far outweigh the unproven benefits – even if we accept the mild and equivocal improvements in some trials.

Further, the political and popular controversy surrounding the question of antibiotics has distracted Lyme care and research away from other avenues that may be more fruitful.

It is interesting that in response to the opinions expressed above, the typical response (I give as evidence various comments to my blog entry from yesterday) is to accuse doctors and scientists of not believing or not caring for patient who believe they have CLD. But read the opinions above – these researchers accept that this population of patient is suffering with symptoms. Their only goal is to understand their true medical situation so as to effectively treat it. They are against the use of antibiotics not because of some defect of empathy, but because the science simply does not support it.

But as we have seen with many grassroots popular campaigns against the scientific medical consensus – having a meaningful conversation between the public and the medical community is all but impossible as the voices that dominate in the public are accusatory bordering on paranoid, distort the scientific opinion, and demonize the medical profession and all who oppose their views.

This replicates the situation seen with the anti-vaccination movement, as well as chelation doctors who claim, despite decades of evidence to the contrary, that chelation therapy can treat heart disease and a long list of other conditions.

In addition to the science being strongly against the belief that there are large numbers of patients suffering from chronic Lyme infection despite antibiotic use, we can begin to see the true complexity of this medical question. The four categories of patients above do not even capture the full range of individual patients that fit into this broad syndrome.

For example, there are patients who come to believe they have CLD because of misinformation they have received on the internet or by others. This then becomes the focus of their attention and their efforts to find help for their symptoms. Meanwhile, the true underlying diagnosis is being missed. Some of these patients may have multiple sclerosis, some other autoimmune disease, a primary sleep disorder, chronic fatigue syndrome, infection with some other agent such as a virus – the list of alternatives is long. Focusing on Lyme disease, in an atmosphere of distrust for the medical profession, is counterproductive in these cases to say the least.

At the other end of the spectrum are the category 4 patients who actually had Lyme disease, maybe even late stage Lyme disease, and now have chronic symptoms (such as fatigue and difficulty concentrating) after being treated. This is a genuine medical mystery at the moment – we do not know why such symptoms persist in a small percentage (maybe 5%) of Lyme patients. It is possible that these are symptoms of cellular damage done by the infection. It is also possible that the infection has triggered a post-infectious immune disorder. It is also possible that a secondary infection that is not sensitive to the antibiotics may be at work.

And there is the possibility that a minority of cases are infected with resistant Lyme. This possibility has not been dismissed or ignored, as is often charged. Rather it has been studied – the results were just negative. Therefore it is prudent to move onto the other hypothesis and study them.

What about patients who believe they have been helped by antibiotics? Most readers will guess my first answer – the well known placebo effect. Also, many of the symptoms of CLD tend to have a natural variation over time in some patients, who will then seek treatment when their symptoms are at their greatest and then credit the inevitable decrease in symptoms on the treatment.

But there are other intriguing possibilities. Baker points out that many antibiotics used to treat Lyme disease also have pharmacological effects, such as anti-inflammatory effects or effects similar to drugs used to treat chronic neurological conditions. This may produce an actual symptomatic benefit in some patients. If this is true, then we can more effectively target CLD symptoms with better and safer anti-inflammatory and neuropathic medications. So far, trials have not been done with these approaches.

There are many other points to be made, but this is sufficient to capture the meat of the issue, and to set up my next point. Individual physicians treating patients with CLD with chronic antibiotics could fall along a very long spectrum. They could have different criteria for who qualifies for treatment. Some may only treat category 3, and only continue treatment if there is an objective response. While others may treatment anybody who thinks they may have CLD with no criteria for monitoring treatment.

With the current system of regulation, each individual practitioner could be judged according to their practice, and individual decisions could be rendered. Having a minority opinion is not sufficient to be disciplined for substandard care, and so some physicians may have looser criteria for prescribing antibiotics and not be targeted for discipline. While there may also be those physicians who are recklessly and dangerously prescribing antibiotics for patients who likely have another specific diagnosis, and truly deserve to have their practice restricted.

Under the proposed law, all such distinctions are wiped away, and there will be blanket protection for anyone prescribing antibiotics for CLD, not matter how they define it and what criteria they use. This is the core absurdity of imposing a simple law upon a complex scientific medical issue.

And as I stated yesterday – this is a rapidly moving target. There are questions that are still being asked, and further research is likely to clarify the situation even further. If the science moves farther and farther away from the use of antibiotics, there is unlikely to be a grassroots lobby to reverse this unwise law. We will be stuck with it, and the state will have lost an important mechanism to protect the public against possibly dangerous quacks who can then exploit this special exemption.

Conclusion

The new CT bill, when passed into law as it almost certainly will be, is a grave mistake. It is legislative arrogance and naivete at the same time. Yet there is likely to be similar efforts in other states. Advocates of ideology tend to be more relentless and motivated than the defenders of reason.

This also reflects a broader syndrome – minority or discredited medical ideas that persist in a cult-like fashion after they have failed the test of scientific evidence. The emotions and thought processes that sustain these movements are remarkably similar across a wide range of issues. What is also distressingly similar is the use (I would argue abuse) of the political process to rig the game of science – to secure political victories to rectify scientific failures. This represents a harmful intrusion of politics into science, and the public suffers.

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14 responses so far

14 Responses to “Chronic Lyme Disease”

  1. stompsfrogson 09 Jun 2009 at 11:16 am

    ha ha, you’ve attracted this ad from google:

    http://www-lymedisease.com/?gclid=CJmih8e8_ZoCFURM5Qod0zwNfA

  2. Karl Withakayon 09 Jun 2009 at 11:55 am

    One problem regarding enacting laws to set specific standards of care is the problems it could cause with research studies. If a standard of care is established by law, (without scientific support for said standard) to what extend does that “legal” standard of medical care apply? Are researchers required by the Helsinki Declaration, to consider that standard of care in research?

    If a law was enacted to say that long term antibiotic therapy shall be the standard of care for conditions conforming to the commonly accepted definition of chronic Lyme disease, does it become unethical to run a study of patients diagnosed with CLD in which one group does not receive long term antibiotics?

    Another problem is that CT is establish a standard of care for a condition they are not really defining.

    The CT bill is essentially a blank check for any licensed physician to treat any patient with long term antibiotic therapy so long as they diagnose the patient with CLD.

    FROM SECTION 1:
    “Lyme disease includes an infection that meets the surveillance criteria set forth by the National Centers for Disease Control and Prevention, and other acute and chronic manifestations of such an infection as determined by a physician, licensed in accordance with the provisions of chapter 370 of the general statutes, pursuant to a clinical diagnosis that is based on knowledge obtained through medical history and physical examination alone, or in conjunction with testing that provides supportive data for such clinical diagnosis. ”

    The bill establishes Chronic Lyme Disease as a legally recognized medical condition (in CT), and sets the minimum criteria for CLD diagnosis as being “as determined by a physician…based on knowledge obtained through medical history and physical examination alone”, not even as determined by a physician in accordance with or subject to accepted medial diagnostic criteria.

    It is interesting to note that the bill, as far as I can tell, provides legal protection for prescription of long term antibiotic therapy for CLD diagnosed patients, but does not specifically provide legal protection for the making the diagnoses of CLD.

  3. Dr J In Trainingon 09 Jun 2009 at 12:11 pm

    So I could set up shop in CT, charge an outrageous out-of-pocket fee to see a patient, then charge their insurance for any antibiotic I feel is appropriate (Zyvox!! PICC lines for all!). And I am legally protected from censure by my medical society?

    Best. Law. Ever.

  4. Steven Novellaon 09 Jun 2009 at 12:11 pm

    Karl,

    The law does not establish a standard of care, it just exempts practitioners from being held to the standard of care when prescribing antibiotics for CLD.

  5. Steven Novellaon 09 Jun 2009 at 12:27 pm

    Dr. J – your comment is likely tounge-in-cheek, but you better believe that is exactly how every unethical charlatan will react to this law. If you build a haven for quackery, the quacks will come.

  6. Karl Withakayon 09 Jun 2009 at 1:33 pm

    Steven,
    I realize that this law does not legally establish a standard of care, the first part of my comment was mostly a hypothetical question regarding potential future legislation carrying the idea a step farther.

    The CT law does, however, legally establish legal recognition in CT of Chronic Lyme Disease, (don’t think the CLD community won’t latch onto that as validation of CLD) and establish a legal diagnostic criteria for CLD as “as determined by a physician…based on knowledge obtained through medical history and physical examination alone”

  7. Elisheva Levinon 09 Jun 2009 at 2:26 pm

    Steven, you are right in citing the same kind of politics for cure claims in autism, and for other health issues.

    Even if the Lyme Disease science were “settled” (as it were!), what is a state legislature doing passing laws about how doctors should treat patients. Treatment is not a matter of law (except in the case of obvious malpractice that infringes on the life and well-being of the patient). Legislators are not physicians nor are they medical researchers, and they ought not to be enshrining any treatment–even the most simple–into law.

    Currently, many of us who live with or care for family members who have chronic illnesses must deal with insurance company bean counters approving or disallowing certain treatments based on issues other than the cutting edge science.
    In CT, the legislature is setting itself up to enshrine a practice into law that is already changing, as you pointed out.

    How much worse will it be when we have Congress doing the same thing as part of a Nationalized Health Care system. It’s coming. And dealing with my state’s DMV for my handicapped sticker, I am not looking forward to the national version of the DMV handling my medical care.

  8. RickKon 09 Jun 2009 at 2:30 pm

    This is an inappropriate response to the Lyme issue, but it’s still a nasty little disease. The woodlands of the Northeast, being free of just about critters that are poisonous or physically dangerous is a wonderful place for kids to play and learn about nature.

    Except for the damned ticks.

    I know a score of people who’ve had mild lyme, and a couple that got to the Bell’s palsy stage. But even worse is the fact that Lyme is making people afraid of nature (or more afraid than they already were).

    Instead of kids running around the woods, we have neighbors insisting their kids stay on permethrin-coated lawns. Piles of fall leaves, once a source of wonderful childhood entertainment, are now treated like toxic waste.

    We don’t spray our lawns – I just can’t stand the idea of killing every insect, frog and snake in our yard. But we do use permethrin spray on shoes and pants, and every summer night we go through the ritual of the “tick check”. I motivate each of my girls with rich cash rewards for every tick picked off her sister.

    Whatever happened to the vaccine? I had two of the three courses before they pulled it from the shelves. Given the affluence of many of the Lyme-infected areas, I’d think an effective vaccine would be profitable even if it only applies to a limited population.

  9. tnkrbellon 10 Jun 2009 at 3:38 am

    Steven,
    Perhaps there is more to this situation then you are aware of considering that the CT Attorney General was forced to intervene here. They did just finish an investigation into wrong-doings with respect to ISDA guidelines for Lyme disease. That entire panel was found to be implicated in wrong doings including monetary dealings with insurance companies and a whole lot more. The whole panel was fired, allowing for new unbiased guidelines to be created (hopefully it will be unbiased anyway).The link for that press release is: http://www.ct.gov/ag/cwp/view.asp?A=2341&Q=414290

    This whole “American “ISDA/antibiotic situation has put a real damper on research and treatment in the US and Canada. Fortunately there is lots of research going on elsewhere where a totally different view of this disease exists.

    Here’s a bit of background on the bacteria responsible for Lyme disease (necessary info when making an informed opinion):
    The spirochete is the form of Bb (the Lyme disease pathogen) that we are all used to hearing about but there are still 3 other forms of Bb. The latter 3 include cystic (L-form), cell wall deficient (CWD) and bleb form (which I am still learning about). Many of today’s antibiotics work by destroying a bacteria’s protective cell wall. When these types of antibiotics are administered during Bb infection, the Bb spirochete quickly transforms into an alternate form and becomes dormant thus causing a clear reduction in and possibly even elimination of symptoms. This behavior actually occurs when any unfavorable conditions for the Bb occur within the human body. Once antibiotics are stopped, these bacteria will revert back into spirochete form and resume their attack on the body. It is unclear at this point (when looking through current research papers) how long these alternate forms can survive without changing back to spirochete form. Perhaps with extended antibiotic regimes it is possible to wait out that survival period [1], [2], [3], [4], [5].

    Long term antibiotic regimes are used for many other illnesses such as urinary infection, leprosy, tuberculosis and even acne and what about antibiotics that are freely and routinely fed to our livestock etc? No-one is making a fuss about this.

    As for the four categories, this list appears to be more indicative of a lack of a “gold standard” test then an admission of guilt. The current test methods were actually created only for epidemiology studies and were never intended for use in patient diagnosis. There are reports of test accuracy being anywhere from 35% to 70% depending on who you ask. Gold standards are at least 95% accurate. That is a far cry from the max of 70%. So basically what this means is that even if a person has Lyme disease there is a pretty big chance they won’t get a positive test result [6].

    The western blot test involves looking fragments of the spirochete proteins. The other 3 forms of the Bb bacteria do not shed the same proteins and thus may not be detected in these tests. Further, there are several different strains of Bb. The only sure way to know whether Bb is residing in your body is to culture your blood/tissue using specialized methods within extended periods of time. These cultures would then need to be viewed using either dark – field microscopy, ESM, or TEM. Then they would actually be seen floating around (costs lots of $$).

    In one study 47 patients were tested using western blot and ELISA. Of these 47 patients only 55% were considered to have a positive result by the CDC criteria. However, when these samples were viewed through microscopy and MAB, all were proven to be positive [6].

    There is so much more to this disease than what meets the eye. Recent research discoveries have shed light on much of the confusion regarding chronic lyme disease and treatment regimes.

    And by the way Multiple Sclerosis has been implicated with Lyme disease on many an occasion [7], [8], [9], [10]

    [1] “Position paper. Spirochete round bodies, Syphilis, Lyme disease & AIDS: Resurgence of “the great imitator”?”, L. Margulis, A. Maniotis, J. MacAllister, J. Scythes, O. Brorson, J. Hall, W. E. Krumbein, and M. J. Chapman. Symbiosis (2009) 47, 51-58

    [2] “Persisting atypical and cystic forms of Borrelia burgdorferi and local inflammation in Lyme neuroborreliosis” J Miklossy, S Kasas, A Zurn, S McCall, S Yu, P L McGeer. Journal of Neuroinflammation (2008) 5:40 doi:10.1186/1742-2094-5-40

    [3] “Morphological Variation: Survival Strategy of Spirochetes” (A Compilation of Research Based Evidence)

    [4] “Cell-Wall-Deficient Bacteria” TSJ Elliot, PA Lambert, The Lancet (2001)Vol 357 Issue 9271 p 1185 doi:10.1016/S0140-6736(00)04991-6

    [5] “A life cycle for Borrelia spirochetes?” MacDonald AB, Med Hypothesis (2006)

    [6] “A Proposal for the Reliable Culture of Borrelia burgdorferi from Patients with Chronic Lyme Disease, Even from Those Previously Aggressively Treated” S. E. Phillips, L. H. Mattman, D. Hulinska, H. Moayad, Infection 26 (1998) 364-367

    [7] “ Association between multiple sclerosis and cystic structures in cerebrospinal fluid”
    Brorson O, Dept. of Microbiology, Vestfold Sentralsykehus, Tonsberg, Norway, Infection 2001 Dec;29(6):315-9

    [8] *”Lyme Borreliosis and Multiple Sclerosis: Any Connection? A Seroepidemic” Jolanta Chmielewska-Badora, Ewa Cisak, Jacek Dutkiewicz, Ann Agric Environ Med 200;7(2):141-3

    [9] “Spirochetal cyst forms in Neurodegenerative disorders, …hiding in plain sight”, Alan B. MacDonald, MD, St. Catherine of Siena Medical Center, Department of Pathology

    [10] “New aspects of the pathogenesis of lyme disease”, Zajkowska JM, Hermanowska-Szpakowicz T, Przegl Epidemiol. 2002;Suppl 1:57-67

  10. [...] response to my post yesterday on Chronic Lyme Disease, commenter “tnkrbell” raised some new points that will take more than a brief comment to [...]

  11. AnnotatedSnarkon 10 Jun 2009 at 12:10 pm

    The link the first commenter mentioned is (typically) amusing yet disturbing (http://www-lymedisease.com/).

    For $39 this guy’ll sell you the secret of how to cure your Lyme disease by consuming four simple ingredients from your local supermarket!

    I dread to think how many quackery websites out there have already evolved beyond being so easily recognized as such simply by looking at the font choices and the page arrangement (even before reading a word of the mind-boggling bullshit).

    Notice, if you will, under the graphic images of bull’s-eye rashes, the inspiring proclamation “Take Action Today – And You Could Be Free From Lyme Disease Symptoms By undefined”. It might be my particular ad-blocking settings that prevent the guy’s Javascript from replacing “undefined” with a date 72 hours from today, or maybe my screen doesn’t support the display of ploys beyond a certain resolution of cheesiness…

    Dr. Novella – how can you sleep at night and ignore an avenue of research that _guarantees_ a symptom-free life for only $2.92 per 3 days (before the credit crunch, I assume)?

    Ever generous, the guy even divulges that two of the four ingredients are salt and vitamin C. We can safely assume the third is Love – any ideas about the fourth?

    Admiring how early in the morning you must wake up,
    J.

  12. birdieon 17 Jun 2009 at 11:53 am

    All of this is very frustrating. There is no middle ground. On one side you have the expressed need for antibiotics and the other side expresses the damage due to prolonged use… but nobody is discussing alternatives. One side against the other… that is a happy little arrangement for progress.

  13. Steven Novellaon 17 Jun 2009 at 1:05 pm

    Birdie – sometimes, there is no middle ground. There is no middle ground between evolution and creation, for example.

    But I disagree that nobody is discussing alternative. If you read the research, the scientists are saying that antibiotics do not seem to be the answer, so we need to investigate other approaches, and they are.

    But regarding this question – the science is what it is. We can’t settle this through compromise, we can only listen to the science.

  14. Shagbarkon 17 Feb 2013 at 8:20 pm

    There are numerous red flags about the IDSA Lyme guidelines.

    - First is the simple fact that tens of thousands of patients were diagnosed with Lyme, had the symptoms of Lyme, were treated with the prescribed course of antibiotics, got better, then relapsed and again had the same symptoms that led to being diagnosed with Lyme, and again tested positive for Lyme. The IDSA guidelines pretend that this never happens, by the simple expedient of not making reference to any of the studies showing these results.

    - If you review the literature, you’ll find that all the evidence indicates that antibiotics can make Lyme asymptomatic but cannot eradicate the infection. There have been at least 5 histological studies of Borrelia species in various animal models, and all of them that showed that a full course of antibiotics does not have any impact on the survival of Borrelia in tissue. I repeat, /no impact/, no change in the percentage of subjects with the bacteria in their tissue before and after treatment, in every tissue, in 5 studies. Most studies of Lyme patients indicate that around 15% of patients relapse after a full course of antibiotics. In numerous cases these patients have been later proven to still have Lyme via PCR or microscopy. Wormser et al. simply refuse to cite any of these studies.

    - Lyme is a spirochete. It can live inside cells where it does not generate an antibody response detectable by ELISA, and it can convert to a cyst form that is unlikely to generate an antibody response. We already know, from many studies, that using antibiotics such as doxycycline and amoxicillin (the two most-frequently prescribed for Lyme) kills mainly Borrelia that are not in the cyst form, and causes them to convert to the cyst form for the duration of treatment. Just do a pubmed search & you’ll find many references on this. There is no reason to expect an ELISA blood test followed by a Western blot to give positive results for someone with chronic Lyme.

    - All of the claims that there is no chronic Lyme come from 3 groups: Allen Steere’s group, Wormser’s group in NY, and Auwaerter’s group at Hopkins. These guys only ever refer to each others’ papers, and they have chaired all the panels on Lyme disease treatment, and kept out anyone who doesn’t agree with them. Just check the Wikipedia entry on chronic Lyme and look at the names on all the references claiming it doesn’t exist.

    - The modus operandi of all their papers is the same: Take the ridiculous CDC 2-step ELISA/Western test, claim that it is 100% accurate, and use it to argue that other tests are inaccurate because they sometimes come up positive. Auwaerter has a new paper out that looks at a cohort of patients who have symptoms of Lyme, and have been shown to have Lyme using synovial-fluid immunoblot testing (and some by PCR!), and then notes that these patients tested negative via blood immunoblot testing. Instead of arguing that the blood immunoblot doesn’t work, he argues that PCR and synovial fluid immunoblots give mysteriously-high false positive rates in patients who claim to have chronic Lyme! I am not making this up. Clinical Vaccine Immunology doi:10.1128/CVI.00383-12, “Misdiagnosis of late Lyme arthritis by inappropriate use of synovial fluid” etc.

    - The original paper that many of them now rely on to establish that ELISA testing is 100% accurate in diagnosing Lyme is Steere 2008, “Prospective study of serologic tests for Lyme disease”, http://cid.oxfordjournals.org/content/47/2/188.full.pdf . This article claims to have shown that 100% of patients with neurologic, cardiac, or arthritic symptoms can be detected with the CDC 2-tier test (table 3). But page 189 of that paper says, “A serologic result positive for > burgdorferi by ELISA and Western blog was required for case inclusion.” In other words, the paper being cited as proof that the CDC test works, proved that 100% of Lyme patients who are already known to test positive on the 2-tier test will test positive on the 2-tier test. I’m not making this up either.

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