New Lyme guidelines from Infectuous Disease Society of America

[musicgirl]

I subscribe to a free daily email called "Physician's First Watch", and the following press release appeared in the 10/4/06 email:
Public release date: 2-Oct-2006
[ Print Article | E-mail Article | Close Window ]


Shelbi Ladd
312-558-1770
sladd@pcipr.com

Ann Geppert
312-558-1770
ageppert@pcipr.com

Updated guidelines on diagnosis, treatment of Lyme disease
Released by the Infectious Diseases Society of America
Alexandria, Va., Oct. 2 -- In response to growing concern and confusion about Lyme disease, the Infectious Diseases Society of America (IDSA) has updated its Clinical Practice Guidelines on the disease, in order to provide guidance to physicians and patients based on the latest scientific evidence. The guidelines were originally published in 2000.

The most significant changes in the updated version include:

The addition of information on human granulocytic anaplasmosis (HGA) and babesiosis, two diseases transmitted by the same tick that transmits Lyme disease;
Recommendations of a single dose of an antibiotic for certain high-risk patients who have been bitten by a tick but do not have symptoms of Lyme disease;
Expanded discussion and definition of so-called "chronic" or post-Lyme syndromes.
The Guidelines, developed by an expert panel according to widely accepted criteria for evidence-based medicine, contain updated information on the epidemiology, clinical features and diagnosis of Lyme disease, according to Gary P. Wormser, Chief, Division of Infectious Diseases and Vice Chairman of the Department of Medicine, New York Medical College. Dr. Wormser is lead author of IDSA's 2006 Lyme disease guidelines and chair of the expert panel that developed the guidelines.

At a Glance


The Infectious Diseases Society of America has updated Guidelines to help physicians and patients in the diagnosis and treatment of Lyme disease.
95 percent of cases of Lyme disease are cured with 10 – 28 days of oral antibiotics.
Long-term antibiotic treatment is not proven to be effective and may be dangerous.
To be certain they get the proper medical care, patients who have lingering symptoms after proper treatment (those with so-called "chronic" Lyme disease) should ask their doctors if the diagnosis was accurate or if they may have a different or new illness.

http://www.journals.uchicago.edu/CID/journal/issues/v43n9/40897/40897.html?erFrom=-6184613732337124553Guest

Musicgirl (member of Braintalk since March 2004).

[lymebytes]

I have seen these guidelines, and I think they are ludicrous! Everyone who has Lyme disease should write to the authors and protest this ignorance.

[Bubbi]

I have seen these guidelines, and I think they are ludicrous! Everyone who has Lyme disease should write to the authors and protest this ignorance.

can I find these guidelines--please.
Debbie
Lymie since 2001

[lymebytes]

Hi Debbie. Here is one place to access them: http://www.docguide.com/news/content.nsf/news/852571020057CCF6852571FB00569D15

[Bubbi]

Thanks! I will read through it and give my thougts :)

[blimeyitslymie]

New IDSA Guidelines Forbid Doctors From Using Clinical Discretion in Diagnosing Lyme Disease

JACKSON, NJ Oct. 10 ─ The national non-profit Lyme Disease Association (LDA), representing more Lyme disease patients than any organization in the United States, objects strenuously and with great alarm, to the restrictive new Clinical Practice Guidelines published this October by the Infectious Diseases Society of America (IDSA.) The new guidelines make it far more likely that Lyme disease will be missed in the early stages, when it is easier to treat. As a result, the guidelines set the stage for creation of a new generation of chronic Lyme disease patients, individuals with Lyme disease diagnosed and treated so late that they may never be cured.

In a nutshell, the reckless new IDSA guidelines forbid doctors from using clinical discretion in determining whether or not patients have Lyme disease. Instead, they require that doctors either see a characteristic rash known to occur in about half the patients, or that patients register positive on the two tests recommended by the Centers for Disease Control & Prevention (CDC) ─ tests known to miss up to half the patients. At any stage of disease, as many as half the patients may remain undiagnosed.

Lyme disease diagnosed late and allowed to disseminate for months or years without treatment causes severe disease that may never completely resolve. Late stage patients suffer more sequelae ─ continued symptoms ─after treatment and are far more likely to fail treatment than patients diagnosed in a timely fashion, with early Lyme disease. Late-stage patients suffering chronic symptoms are frequently very sick and in great pain, often as impaired as those with congestive heart failure and sicker than people with type two diabetes.

Despite the basic math and the documented sequelae of late-diagnosed and late-treated Lyme disease, the new IDSA Guidelines state (without offering evidence or any supporting citations) that most Lyme patients are diagnosed early. This defies the experience of the LDA and of the patient community. It is also flies in the face of a study, now in press at the Journal of Evaluation in Clinical Practice, which has found that when patients fail treatment, the reason is overwhelmingly because they were diagnosed and treated late.

The IDSA guidelines also deny that chronic persistent infection exists, arbitrarily dismissing all studies documenting persistent infection after short-term therapy and ignoring mounting evidence that more treatment is beneficial in chronic cases.

Finally, the IDSA guidelines fail to even mention another set of diagnostic and treatment guidelines published by the International Lyme and Associated Diseases Society (ILADS) listed with the National Guideline Clearinghouse,
which offer an alternative view of Lyme disease diagnosis and treatment.

LDA understands that the debate over the cause of chronic Lyme disease continues to be contentious and to divide those treating and studying the disease. There continue to be two standards of care. But the need to diagnose Lyme disease early enough to obtain the best treatment outcome and most favorable prognosis has never been controversial. Despite this, the IDSA guidelines are so draconian they stand poised to let many patients slip through the cracks and elude diagnosis until they are suffering late-stage, difficult-to-treat Lyme disease. As the voice of the Lyme disease patient community, LDA challenges these guidelines on humanitarian grounds.

[blimeyitslymie]

http://www.capecodonline.com/archives/7days/mon/letts.htm

Cape Cod Times
Hyannis MA
October 9, 2006

New Lyme guidelines ill-serve sufferers

The Infectious Disease Society of America (IDSA) has issued new
guidelines for the diagnosis and treatment of Lyme disease. The
guidelines are torturously and unnecessarily complex, and
unquestioningly will lead to the continuing undertreatment and
nontreatment of Lyme.

This, after 25 years of ''a bull's-eye rash and swollen knees''
as the diagnostic standard, when it in fact accounted for less than
10 percent of initial presentations. Coupled with a blood test, the
ELISA, shown to be little better than chance, we are left here on
the Cape and Islands with hundreds of people with chronic Lyme and
other debilitating syndromes of ''mysterious'' origin, such as
chronic fatigue syndrome and fibromyalgia.

The IDSA further eschews long-term antibiotic treatment as
useful with chronic Lyme. This is based entirely on one flawed study
where antibiotic treatment was over a relatively short term, and the
experimental group was biased by a shared genetic profile.

Many of us in the Lyme patient community can testify to the
efficacy of long-term antibiotic treatment.

In a Lyme-endemic area, the public deserves far better than
what the IDSA has given us.

Harold Roy
Brewster

****
Letters to the Editor (online form):
http://www.capecodonline.com/cctimes/edits/sendaletter.htm

[blimeyitslymie]

From Phyllis Mervine, of CALDA (California Lyme Disease Association) www.lymedisease.org


1) Has anyone read the new guidelines? How do you like them? Are they worse than the old ones? How do you feel about them? Do you think your doctor will pay attention to them? Will other GPs follow them? Do you think they will they affect healthcare for people with TBDs? Do you want to do something about the situation? What do you want to do? What do you think the community should do about them (if anything)?
Phyllis



2) LDA is looking for evidence of Infectious Disease doctors putting pressure on other doctors or pharmacists to prevent treatment. Personal accounts of what they do with a patient is not what they are looking for. Send the information privately to Pat Smith, President of LDA (Lyme Disease Association) LYMELITER@aol.com. Please be as specific as possible. Name of ID doc, where and when this took place who was present (can be specific names or generic group e.g. other hospital doctors), what was said, any supporting documentation.

3) People, please contact your newspapers and see if you can get them to carry this article. IDSA meeting is this week and no doubt the newswires will carry their PR very soon. This is a chance for us to get our story out. The new guidelines are very bad, make no bones about it. We need to challenge them. Please share on this group any efforts you make and name the papers so we will have an idea of who is doing what. I will contact papers in Lake and Mendocino Counties in California. To find emails and websites and contact info about papers in the US, go to http://www.usnpl.com/ and click on your state. Papers usually prefer receiving articles in the body of an email rather than as attachments. You can cut and paste press release below.

3) FYI, a pdf of the complete guidelines can be obtained at http://www.journals.uchicago.edu/CID/journal/issues/v43n9/40897/40897.web.pdf



Lyme Disease Association, Inc.
PO Box 1438, Jackson, New Jersey 08527
888-366-6611 Lymeliter@aol.com 732-938-7215 (Fax)

LymeDiseaseAssociation.org

For Immediate Release:
Contact: Vicky Jaffe, MS&L

(617) 937-2578, Vicky.jaffe@mslpr.com


The national non-profit Lyme Disease Association (LDA), representing more Lyme disease patients than any organization in the United States, objects strenuously and with great alarm to the restrictive new Clinical Practice Guidelines published this October by the Infectious Diseases Society of America (IDSA.) The new guidelines make it far more likely that Lyme disease will be missed in the early stages, when it is easier to treat. As a result, the guidelines set the stage for creation of a new generation of chronic Lyme disease patients, individuals with Lyme disease diagnosed and treated so late that they may never be cured.

In a nutshell, the reckless new IDSA guidelines forbid doctors from using clinical discretion in determining whether or not patients have Lyme disease. Instead, they require that doctors either see a characteristic rash known to occur in about half the patients, or that patients register positive on the two tests recommended by the Centers for Disease Control & Prevention (CDC) - tests known to miss up to half the patients. At any stage of disease, as many as half the patients may remain undiagnosed.

Lyme disease diagnosed late and allowed to disseminate for months or years without treatment causes severe disease that may never completely resolve. Late stage patients suffer more sequelae - continuing symptoms - after treatment and are far more likely to fail treatment than patients diagnosed in a timely fashion, with early Lyme disease. Late-stage patients suffering chronic symptoms are frequently very sick and in great pain, often as impaired as those with congestive heart failure and sicker than people with type two diabetes.

Despite the basic math and the documented sequelae of late-diagnosed and late-treated Lyme disease, the new IDSA Guidelines state (without offering evidence or any supporting citations) that most Lyme patients are diagnosed early. This defies the experience of the LDA and of the patient community. It is also flies in the face of a study, now in press at the Journal of Evaluation in Clinical Practice, which has found that when patients fail treatment, the reason is overwhelmingly because they were diagnosed and treated late.

The IDSA guidelines also deny that chronic persistent infection exists, arbitrarily dismissing all studies documenting persistent infection after short-term therapy and ignoring mounting evidence that more treatment is beneficial in chronic cases.

Finally, the IDSA guidelines fail to even mention another set of diagnostic and treatment guidelines published by the International Lyme and Associated Diseases Society (ILADS) listed with the National Guideline Clearinghouse, which offer an alternative view of Lyme disease diagnosis and treatment.

LDA understands that the debate over the cause of chronic Lyme disease continues to be contentious and to divide those treating and studying the disease. There continue to be two standards of care. But the need to diagnose Lyme disease early enough to obtain the best treatment outcome and most favorable prognosis has never been controversial. Despite this, the IDSA guidelines are so draconian they stand poised to let many patients slip through the cracks and elude diagnosis until they are suffering late-stage, difficult-to-treat Lyme disease. As the voice of the Lyme disease patient community, LDA challenges these guidelines on humanitarian grounds.

[blimeyitslymie]

(this was too long to post in one thread, so split into three parts)

October 25, 2006
Sherwood Gorbach, M.D., Editor
Clinical Infectious Diseases
Tufts University School of Medicine
200 Harrison Avenue
Boston, Massachusetts 02111

Subject: Retraction of "The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical practice guidelines by the Infectious Diseases
Society of America."

Dear Dr. Gorbach:

On behalf of the membership of the International Lyme and Associated Diseases Society (ILADS), I am submitting a formal request for retraction of the article, "The clinical assessment, treatment, and
prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: Clinical practice guidelines by the Infectious Diseases Society of America¡ (hereafter referred to as the "Lyme guidelines article"), which has been published electronically in your journal (1).

ILADS is requesting retraction of the Lyme guidelines article because the authors of the article employed exclusionary data selection that substantially biased the resulting diagnosis and treatment recommendations while ignoring opposing or dissenting views about these recommendations. As with research articles tainted by data selection, the Lyme guidelines article threatens to harm patients and patient care due to the biased methodology used by the authors, and this threat can only be avoided by formal retraction of the article.

The attached analysis of key points in the Lyme guidelines article demonstrates that the authors of the article made statements that either reflected significant selection bias of published data or ignored
published evidence that conflicted with their opinions. Nowhere is this more apparent than in Dr. Klempner's analysis of the three NIH-funded Lyme treatment studies, which elevates and relies on the findings of his own study while dismissing the results of two other studies that conflict with his findings. Other statements about the erythema migrans (EM) rash, Lyme testing methodology, antibiotic treatment of chronic Lyme disease, Lyme disease in pregnancy and Lyme disease in Southern states all reflect a biased view of Lyme disease that is either unsubstantiated or refuted by available peer-reviewed published literature.

It is disturbing that ten of the central recommendations in the guidelines are supported by evidence ranked E-III; that is, very strong recommendations based on the weakest level of evidence opinion. In light of the controversy surrounding Lyme disease diagnosis and treatment and our evolving understanding of the
disease, it is inappropriate to dictate medical care based on such weak evidence. The panel of authors was selected to exclude divergent points of view from patients, from treating physicians in other medical societies, and even from physicians within IDSA itself. The failure of the authors to disclose dissenting views presents a false sense of consensus on an issue that is in fact highly controversial, misinforming
patients and physicians alike about available treatment options and denying the exercise of clinical discretion and individualized medical decision-making that is central to any complex illness.

Although the Lyme guidelines article boasts 405 references, many of the dissenting references are either glossed over or ignored in the text. In addition, as of the date of publication of the Lyme guidelines article
there were 18,537 articles about tick-borne diseases listed on Medline, so the referenced articles represent only 2% of the available literature. The remaining 98% of these articles often present opposing or conflicting views of Lyme disease, and thus the data selection by the authors is even more striking.

We are aware that retraction of medical publications is generally reserved for research articles that violate principles of scientific integrity (2). Scientific integrity has been defined as commitment to truthfulness, to personal accountability and to vigorous adherence to standards of professional conduct (eg, accuracy, fairness, collegiality, transparency) (3). Clinical guidelines from societies as powerful as IDSA are generally accepted as accurate, fair, collegial and transparent, and they rapidly become the standard of medical care in our country. It is wholly inappropriate and dangerous for guidelines to be formulated using exclusionary tactics, flagrant data selection, biased opinions and sweepingly strong recommendations based on the
weakest category III evidence. We feel that the same principles of scientific integrity that apply to medical research should also apply to practice guidelines. In our opinion, the Lyme guidelines article does
not reflect accuracy, fairness, collegiality or transparency and should be retracted.

We propose the following:
1. Immediate retraction of the published Lyme guidelines article.

2. Formal notification of the CDC and other medical societies that the guidelines article has been retracted.

3. Formation of a widely diversified Lyme guidelines committee that bases its recommendations on the strength of the underlying evidence.

4. Reformulation of the Lyme guidelines article to reflect a more balanced view of tick-borne diseases, taking into account the existing evidence-based ILADS guidelines article listed by the National
Guidelines Clearinghouse (4).

5. Submission of the reformulated guidelines article for outside peer review to a medical journal that is independent of IDSA.

Sincerely,

Raphael Stricker, MD
President, ILADS

References

1. Wormser GP, Dattwyler RJ, Shapiro ED, Halperin JJ, Steere AC, Klempner MS, Krause PJ, Bakken JS, Strle F, Stanek G, Bockenstedt L, Fish D, Dumler JS,

Nadelman RB. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006 Nov 1;43(9):1089-134. Epub 2006 Oct 2.

2. Warner TD, Roberts LW. Scientific integrity, fidelity and conflicts of interest in research. Curr Opin Psychiatry. 2004;17:381-5.

3. Institute of Medicine National Research Council of the National Academies. Integrity in scientific research. Washington, DC: The National Academies Press, 2002.

4. The ILADS Working Group. Evidence-based guidelines for the management of Lyme disease. Expert Rev Anti-Infect Ther 2004;2:S1-S13.

[blimeyitslymie]

ISDA claims in italics
ILADS response in bold

Infectious Disease Society of America (IDSA) Claims Fact
Lyme Disease Diagnosis and Treatment Critique of IDSA 2006 Guidelines

LYME DISEASE IS HARD TO CATCH, EASY TO CURE

Lyme disease is rare and occurs in limited locations

The disease is easy to diagnose

Lyme testing is reliable

Treatment rarely fails

Chronic Lyme disease does not exist


ILADS Position Overview:

LYME DISEASE AND COINFECTIONS RESULT IN A COMPLEX ILLNESS THAT REQUIRES CLINICAL JUDGEMENT TO DIAGNOSE AND TREAT

Lyme disease and other tick-borne coinfections are spreading

Tick-borne coinfections make treatment of Lyme disease more difficult

Lyme testing is unreliable

Borrelia burgdorferi is difficult to eradicate, and treatment failure is more common than we think

Prolonged antibiotic therapy appears to be useful and appropriate in persistent Lyme disease

The IDSA's one-size fits all approach to Lyme diagnosis and treatment will result in the misdiagnosis and denial of care of many thousands of patients a year, creating a public health burden as many of these patients become chronically ill and disabled.

THE LYME BULLSEYE RASH IS ALL IMPORTANT

The great majority of persons with B. burgdorferi infection present with erythema migrans.[bullseye rash]

Extracutaneous [non-rash] manifestations are less commonly seen.

The more indolent forms of neurologic Lyme disease are quite rare.


LYME IS FREQUENTLY A NEUROLOGICAL DISEASE, NOT A SKIN DISEASE

Only 35-68% of Lyme patients present with a bullseye rash, [1][2] but up to 40% develop neurologic involvement of either the peripheral or central nervous system.[3] The IDSA overemphasis on the rash and denial of many common neuropsychiatric symptoms will result in missed diagnoses and a future epidemic of late stage disease.

Many IDSA-cited studies are flawed because of selection bias for those subjects presenting with a bullseye rash. The exclusion of Lyme disease patients with no rash leads to an artificially high estimate of the incidence of the rash among patients infected with B. burgdorferi. Furthermore, IDSA guidelines make no reference to the large body of Lyme-related psychiatric literature, and there were no psychiatrists on the guidelines panel.


TESTING IS RELIABLE AND MANDATORY

Clinical findings alone are not sufficient for diagnosis of extracutaneous [non-rash] manifestations of Lyme disease* Diagnostic testing* is required for confirmation.


CLINICAL JUDGMENT IS ESSENTIAL, BECAUSE TESTS MAY MISS OVER HALF OF POSITIVE CASES

Diagnosis should be based on clinical signs, symptoms, history, exposure, risk, and course of illness. When laboratory tests are not a gold standard (at least 95% sensitive), clinical discretion is essential. In the case of Lyme disease, the FDA-approved kits are 36-70% sensitive.[7] Diagnosis should be based on clinical signs, symptoms, history, exposure risk, and course of illness, with tests playing a supportive role. Since early treatment is essential for a favorable outcome, why is the IDSA supporting an overly restrictive diagnostic protocol that results in a high percentage of non-rash patients becoming chronically ill?

NIH: Until better tests are available, the diagnosis of Lyme disease must be based on characteristic clinical findings in which the results of laboratory tests play a supportive role.[4]

FDA: A patient with active Lyme disease may have a negative test result.[5]

The sensitivity and specificity of the currently used tests for Lyme disease are not adequate to meet the two-tier test approach being recommended. Ideally, a screening test should have a high degree of sensitivity (95%).[6]

ELISA: Sensitivities of 3 commercial ELISAs ranged from 36.8% to 70.5%[7]

WESTERN BLOT: The sensitivities of the IgM and IgG immunoblot for detecting patients who were seropositive into the study period were 58.5 and 54.6% [8] Luger and Krause found up to a 56% false-negative rate.
[9]

IDSA-recommended tests are antibody tests, and only 70% of the documented Lyme patients in these 2 studies had a significant antibody response.[10][11]


CDC SURVEILLANCE CRITERIA SHOULD BE USED FOR DIAGNOSIS
Serum samples should be tested using the 2-tier testing algorithm recommended by the Centers for Disease Control and Prevention.


USING OVERLY STRICT CDC CRITERIA MISSES UP TO 75% OF POSITIVE CASES

The CDC explicitly states that this definition is intended for surveillance purposes only, and is "not intended to be used in clinical diagnosis." [12][13]

College of American Pathologists (CAP): ELISA assays for Lyme Disease do not have adequate sensitivity to be part of the two-tiered approach of the CDC/ASPHLD[6]

Johns Hopkins 2-yr study (2005): The CDC 2-tiered testing procedure misses 75% of positive Lyme cases[14]

NY Dept. of Health Letter (1996): CDC 2-tiered testing procedure misses 81% of positive Lyme cases.[15]


14-28 DAYS OF ANTIBIOTICS WILL CURE LYME

There is no convincing biological evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease.


THIS SLOW-GROWING, EVASIVE SPIROCHETE OFTEN REQUIRES LONGER ANTIBIOTIC COURSES

Substantial treatment failures occur using standard protocols. Longer term treatment may be necessary. B. burgdorferi may persist in humans and animals for months or years despite a robust immune response and
standard antibiotic treatment, particularly when treatment is delayed and dissemination is widespread. Numerous studies have demonstrated persistence of infection despite antibiotic therapy.

If the IDSA treatment limits are automatically adopted by insurance companies as they have been in the past, thousands of chronically ill Lyme patients will be forced to pay for expensive, possibly life-saving
treatments out of pocket, risking the loss of their life savings and their good health. Quality of care will be compromised because the most needy patients will be denied care based on these IDSA one-size-fits-all guidelines.

Treatment for 14-21 days results in a 26-50% failure rate. [16]

Persistence of B burgdorferi despite antibiotic treatment demonstrated by post-treatment isolation of the bacteria. [17]


ANTIBIOTICS DON'T HELP CHRONIC LYME PATIENTS

Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (6 months) subjective symptoms after recommended treatment regimens for Lyme disease. In many patients, posttreatment symptoms appear to be more related to the aches and pains of daily living rather than to either Lyme disease or a tickborne coinfection.


MOST CHRONIC PATIENTS IMPROVE WITH TREATMENT

Clinical and research evidence shows that long-term antibiotics can significantly improve the quality of life for patients with chronic Lyme disease. The potential harm in letting a persistent Lyme infection go
untreated far outweighs the potential side-effects of long-term antibiotic use. If long-term oral antibiotic therapy is considered safe enough for acne patients, its use is certainly justified for chronic Lyme patients. Intravenous therapy is justified for serious, refractory cases or those with clear central nervous system involvement. Risks are minimized by skilled clinicians who take appropriate precautions.

Two NIH-funded double-blind studies support retreatment of those failing short-term approaches. Recently completed trial (not yet published) at Columbia University showed the efficacy of at least 10 weeks of IV
treatment.[18] Krupp showed efficacy of retreatment in terms of fatigue.[19] Five uncontrolled studies support longer treatment approaches.[20-24]


PREGNANT WOMEN SHOULDN'T WORRY ABOUT HAVING LYME DISEASE

There is little evidence that a congenital Lyme disease syndrome occurs.


PREGNANT WOMEN SHOULD BE FULLY INFORMED OF THE RISKS OF TICK-BORNE DISEASES

Lyme disease, as well as other tick-borne infections, can be transmitted from an infected mother to fetus through the placenta during pregnancy, possibly resulting in complications or stillbirth.[25-26]

46 cases of adverse outcomes of gestational Lyme borreliosis were found, including miscarriage, stillbirth, perinatal death, congenital anomalies, systemic illness, early-onset fulminant or mild sepsis and later-onset chronic progressive infection.[27]

Transmission to the fetus demonstrated in murine model.[28]

B burgdorferi DNA has been detected in human breast milk.[29]


THERE IS NO LYME DISEASE IN THE SOUTH

The panel is unaware of a proven case of B. burgdorferi infection acquired indigenously in any state south of Maryland or Virginia.


THERE ARE NUMEROUS DOCUMENTED CASES OF INDIGENOUS LYME DISEASE IN THE SOUTH

Indigenous Lyme disease has been documented by clinicians, military bases, and health departments across the southern states. With early treatment being essential for a favorable outcome, it behooves southern
physicians and epidemiologists to remain open-minded about Lyme disease as a differential diagnosis, especially with the ease by which it can be acquired while traveling out of state. If front-line physicians are told Lyme is rare, based on opinion only, it could result in missed diagnoses and a future epidemic of late stage disease.

From 1984 C1989, 104 indigenous cases of Lyme disease were reported in North Carolina. [30-31]

[blimeyitslymie]

From 1997-2000, there were 44 cases of Lyme disease on Navy and Marine bases in North Carolina. [32]

The U.S. Army conducts regular Lyme Disease Risk Assessments (LDRAs) at military installations and has determined that these southern states have been designated as HIGH RISK for Lyme (AR, CA); MODERATE RISK (NC, SC, CA, FL, KY) and SOME RISK (FL, GA, LA, MO, OK). [33]

In 2005, the CDC reported 313 cases of Lyme disease in states south of Virginia.[34]

NIH, National Institute of Health; CDC, Centers for Disease Control & Prevention; FDA, Food & Drug Administration; ELISA, enzyme-linked immunosorbent assay


References

1. Stricker RB et al: Lyme disease without erythema migrans: cause for concern? Am J Med 2003; 115:72.

2. Centers for Disease Control and Prevention (CDC). Lyme Disease C USA, 2001 C2002. Morb Mortal Wkly Rep 2004;53(17):365¨C369.

3. Fallon BA, Nields JA. Lyme disease: a neuropsychiatric illness. Am J Psychiatry 1994;151:1571-1583

4. National Institute of Allergies and Infectious Diseases (National Institute of Health). How Lyme Disease Is Diagnosed.1999. Available from: http://www.niaid.nih.gov/dmid/lyme/diagnosis.htm

5. Food & Drug Administration. Lyme disease test kits: potential for misdiagnosis. FDA Medical Bulletin, 1999, Summer, Final Issue. http://www.fda.gov/medbull/summer99/Lyme.html

6. Bakken LL, Callister SM, Wand PJ, Schell RF. Interlaboratory comparison of test results for detection of Lyme disease by 516 participants in the Wisconsin State Laboratory of Hygiene/College of
American Pathologists Proficiency Testing Program. J Clin Microbiol 1997; 35(3):537-43.

7. Marangoni A, Sparacino M, Cavrini F, Storni E, Mondardini V, Sambri V, Cevenini R. Comparative evaluation of three different ELISA methods for the diagnosis of early culture-confirmed Lyme disease in
Italy. J Med Microbiol 2005;54:361-367

9. Engstrom SM, Shoop E, Johnson RC. Immunoblot interpretation criteria for serodiagnosis of early Lyme disease. J Clin Microbiol 1995;33(2):419-27.

8. Luger SW, Krauss PJ. Serologic tests for Lyme disease: interlaboratory variability. Arch Intern Med 1990;150:761-763.

10. Aguero-Rosenfeld ME, Nowakowski J, McKenna DF, Carbonaro CA, Wormser GP. Serodiagnosis in early Lyme disease. J Clin Microbiol 1993;31:3090-3095.

11. Aguero-Rosenfeld ME, Nowakowski J, McKenna DF, Carbonaro CA, Wormser GP. Evolution of the serologic response to Borrelia burgdorferi in treated patients with culture-confirmed erythema migrans. J Clin
Microbiol 1996;34:1-9.

12. Lyme Disease (Borrelia burgdorferi): 1996 Case Definition. CDC Case Definitions for Infectious Conditions under Public Health Surveillance.

13. CDC Testimony before the Connecticut Department of Health and Attorney General's Office. CDC's Lyme Prevention and Control Activities. http://www.hhs.gov/asl/testify/t040129.html

14. Coulter P, Lema C, Flayhart D, Linhardt AS, Aucott JN, Auwaerter PG, Dumler JS. Two-Year Evaluation of Borrelia burgdorferi Culture and Supplemental Tests for Definitive Diagnosis of Lyme Disease. J Clin.
Microbiol 2005;43:5080-5084

15. Letter from B. DeBuono of NY Dept. of Health to C. Fritz of CDC. April 15, 1996.

16. Wahlberg P, Granlund H, Nyman D, Panelius J, Seppala I. Treatment of late Lyme borreliosis. J Infect 1994;29(3):255-61.

17. Oksi J, Marjamaki M, Nikoskelainen J, Viljanen M. Borrelia burgdorferi detected by culture and PCR in clinical relapse of disseminated Lyme borreliosis. Ann Med 1999; 31(3): 225-32.

18. Fallon BA. Laboratory findings in chronic Lyme disease and results of the controlled treatment study. Lyme & Other Tick-Borne Diseases:Technology Leading the Way Conference; 2004 October 22, 2004;
Rye Town, NY.

19. Krupp LB, Hyman LG, Grimson R, Coyle PK, Melville P, Ahnn S,Dattwyler R, Chandler B. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology 2003;
60(12):1923-30.

20. Donta ST. Macrolide therapy of chronic Lyme Disease. Med Sci Monit 2003;9(11):136-42. PMID 14586290.

21. Donta ST. Tetracycline therapy for chronic Lyme disease. Clin Infect Dis 1997;25(Suppl 1):S52-6. PMID 9233665.

22. Wahlberg P, Granlund H, Nyman D, Panelius J, Seppala I. Treatment of late Lyme borreliosis. J Infect 1994;29(3):255-61. PMID 7884218.

23. Oksi J, Nikoskelainen J, Viljanen MK. Comparison of oral cefixime and intravenous ceftriaxone followed by oral amoxicillin in disseminated Lyme borreliosis. Eur J Clin Microbiol Infect Dis 1998;17 (10):715-9.
PMID 9865985.

24. Fallon BA, Tager F, Fein L, Liegner K, Keilp J, Weiss N, Liebowitz M. Repeated antibiotic treatment in chronic Lyme disease. J Spirochet Tick-Borne Dis 1999;6(3):94-102.

25. MacDonald AB. Gestational Lyme borreliosis. Implications for the fetus. Rheum Dis Clin North Am 1989;15(4):657-77.

26. Schlesinger PA, Duray PH, Burke BA, Steere AC, Stillman MT. Maternal-fetal transmission of the Lyme disease spirochete, Borrelia burgdorferi. Ann Intern Med 1985;103 (1): 67-8.

27. Gardner T. Lyme disease. In: Remington JS and Klein JO, editor(s). Infectious diseases of the fetus and newborn infant. Philadelphia: Saunders; 1995. p. 447-528.

28. Silver RM, Yang L, Daynes RA, Branch DW, Salafia CM, Weis JJ. Fetal outcome in murine Lyme disease. Infect Immun 1995;63(1):66-72.

29. Schmidt BL, Aberer E, Stockenhuber C, Klade H, Breier F, Luger A. Detection of Borrelia burgdorferi DNA by polymerase chain reaction in the urine and breast milk of patients with Lyme borreliosis. Diagn Microbiol Infect Dis 1995; 21(3):121-8.

30. Levine JF, Apperson CS, Spiegel RA, Nicholson WL, Staes CJ. Indigenous cases of Lyme disease diagnosed in North Carolina. South Med J 1991;84(1):27-31.

31. Pegram PS, Sessler CN, London WL. Lyme disease in North Carolina. South Med J 1983;76(6):740-2.

32. McGinnis J, Bohnker BK, Malakooti M, Mann M, Sack DM. Lyme disease reporting for Navy and Marine Corps (1997-2000). Mil Med. 2003;168(12):1011-4.

33. U.S. Army Lyme Disease Assessment Reports 1983-1996. http://members.utech.net/users/10766/lyme.htm

34. CDC. Summary of notifiable diseases, United States, 2005. Morb Mortal Wkly Rep 2005;53(53)

cc: Julie L. Gerberding, MD, MPH, Director, CDC
Michael O. Leavitt, Secretary, U.S. Department of Health and Human Services
Elias A. Zerhouni, MD, Director, NIH
Anthony S. Fauci, MD, Director, NIAID
Andrew C. von Eschenbach, MD, Director, FDA
Jesse L. Goodman, MD, Director, CBER
Jay E. Berkelhamer, MD, FAAP, President, American Academy of Pediatrics
Mary K. Crow, MD, President, American College of Rheumatology
Lynne M. Kirk, MD, FACP, President, American College of Physicians
Larry S. Fields, MD, FAAFP, President, American Academy of Family Physicians
Martin J. Blaser, MD, FIDSA, President, Infectious Diseases Society of America

[blimeyitslymie]

CALL TO ACTION

from Pat Smith, President, Lyme Disease Association, Inc. (LDA)

"Crime against Lyme"

October 9, 2006 is a sad day for humanity and, in particular, for
the Lyme community. That day, a group of people entrusted with the
lives of patients published a document which commits those same
patients to lifelong debilitation and suffering -- an action beyond
rational comprehension. For those now adversely affected, it seems
as though they have won, and we have lost. Appearances can be
deceiving.

There is a law in physics which states: for all action, there is an
opposite and equal reaction. Not recommending -- effectively banning
-- clinical discretion and classes of drugs, alternative treatments,
and even supplements for any manifestation of Lyme disease is an
action so reprehensible that it already has precipitated the plan
for that opposite and equal reaction.

Lyme leaders across the nation have been teleconferencing and
meeting almost non-stop to develop an action plan. That plan is
designed to show the world that Lyme patients are not victims, Lyme
patients are not helpless, Lyme patients are not incapable of
fighting back. The plan is predicated on the fact that justice must
be served.

We have pulled together a team of experts, and Lyme groups
nationwide have been uniting so that the actions that are taken will
be unified and focused. We have apprised appropriate constituencies
of our actions and will continue to as actions unfold

As you know, it would be inappropriate to discuss all actions
publicly at this time. We will, however, be letting you know each
time an action is needed, and many will be needed. We need
everyone's help. This is not the time to bicker amongst ourselves
about who knows what when, but it is the time to network amongst
ourselves about who can do what when. Some of the actions we
propose will require more effort on your part. When that happens,
we trust that those of you who are able will support such actions.
Other actions may require a lesser effort but might need greater
numbers. All should be able to participate to make this campaign
successful.

Because so many are ill, we ask that groups out there keep your own
group initiatives limited so that patients won't have to make a
choice. A lot of people have good ideas, but fragmented actions do
not have a large impact -- 20 small petitions, for example, do not
have the same effect as one large one. We think the choice needs to
be the nationally coordinated campaign, because the chances of
success will be greater if we are all working together.

Additionally, some groups may take actions inadvertently which may
endanger other actions already begun nationally. There are some
localized actions you can take, however. If you are not in a group
and none operates near you, join an online group, or you can take
most actions as an individual. If you have a group, mobilize:

-actively recruit people for your group
-update your contact lists (telephone, fax, email):
-all newspapers in your group area (include weeklies), radio, TV
-all reporters you have established a relationship with over
time
-all federal legislators in your state, both US House and US
Senate,
-your state officials in both houses, your governor,
-your group members with note in which congressional and state
districts they reside
-write letters to the editor in your local papers describing how
guidelines affect you/family

To begin, we have a petition on www.LymeDiseaseAssociation.org
website for those 18 years and older to sign. Send to your entire
address book, as I have to mine. Get family members, friends, and co-
workers, ask them to circulate it among their lists. Who would
oppose a petition asking for Lyme patients to be accorded the most
basic of human rights, given even to our enemies, the right to be
treated when sick? Names and addresses will NOT appear on the
internet but will be printed out with the petition when it is ready
to be presented to the appropriate entity. LDA never sells names or
shares them with marketers. The petition will be used in an effort
to advance our cause at the appropriate time and will be kept
private until that time. Remember, like you, LDA is all patients and
families of patients -- and all volunteer.

The Lyme treatment gatekeepers have never been really challenged.
That is about to change, and we will all be a part of that
challenge. It will require courage, compassion, intelligence,
endurance and effort on the part of our community, but I know we can
accomplish great things together. We must, because our lives and
those of our families and friends are at stake now. Five years
without treatment is not an option. We must and will prevail.

Pat Smith, President
Lyme Disease Association, Inc.
PO Box 1438
Jackson, NJ 08527
888-366-6611 information line
732 938-7215 fax
www.LymeDiseaseAssociation.org

[blimeyitslymie]

Hey all,

I sent this link to all my family and friends in my email directory. I urge you to do the same. There are over 6100 signatures at last count! Let's keep the ball rolling and let our voices be heard!


http://www.lymediseaseassociation.org/referral/Petitions/Petition.php?id=1

[blimeyitslymie]

Call to Action #3 - Pat Smith
Posted by: "Rose" toil_for_lyme@yahoo.com toil_for_lyme
Sat Nov 11, 2006 10:24 am (PST)
 From: Pat Smith

CALL TO ACTION #3

from Pat Smith, President, Lyme Disease Association, Inc. (LDA)

"Crime against Lyme"

NEW ACTIONS!

1. Important, Save the Date!

· Thursday November 30, 2006 The Lyme Rights Rally Group
(you may remember them from Hartford Rally 2006) requests that you
save that day, particularly if you live in the Northeast

· You won't want to miss this opportunity to make your voice
heard.

· More details will follow from Lyme Rights Rally Group early
next week.

ONGOING ACTIONS!

1. Continue to get signers onto the petition- We are going on
14,000, keep it up!

2. Continue contacts with your local media about Guidelines impact
on you/family/friends- You have sent dozens of letters to
newspapers and a number have been published. Mention petition
please. A number of Guidelines articles have appeared, too.


3. Continue VERY IMPORTANT STILL

Contact (phone/email) all of your FEDERAL legislators: your own US
Congressman and your two US Senators by November 15 at Washington ,
DC office only . The contact should be with current legislator, NOT
any newly elected who do not take office until new year (actions may
take this session still so need support of current legislators) .
Groups should contact all Congressmen within their range (area they
cover).


US Reps. & Senators DC contact information http://www.visi.
com/juan/ congress/

· Tell them how Guidelines impact you/family/friends.

· Tell them CDC has essentially adopted the Guidelines (on
their website)

4. Those patients already impacted by new guidelines, a form was
sent out online for you to fill out. Thanks to those who have
already responded, and if you still want to respond, please email
Lymeliter@aol. com for the form. You must have been denied services
after Oct 2, 2006 with the Guidelines used as basis.

Keep up the actions please. Thanks!

Pat Smith, President
Lyme Disease Association, Inc.
PO Box 1438
Jackson, NJ 08527
888-366-6611 information line
732 938-7215 fax
www.LymeDiseaseAsso ciation.org

[blimeyitslymie]

Letter from Lyme Rights - Lyme Rights Protest, Nov. 30 (NY)
Posted by: "Rose" toil_for_lyme@yahoo.com toil_for_lyme
Wed Nov 15, 2006 10:37 am (PST)
RoseNote: For more information, please go to the Lyme Rights website at:
http://lymenews.org/html/letter_from_lrr_group.html

INFECTIOUS DISEASES SOCIETY OF AMERICA
HAS DECLARED WAR ON LYME PATIENTS

Dear Friends,

Chronic Lyme disease has been banished as a disease! No conventional or
alternative treatments are recommended! Doctors cannot make a clinical
diagnosis anymore!

It is time for patients to fight back! Your participation is critical!
Numbers count!

Patients are already being cut off. Doctors are backing off treating.
There is no wiggle room in the new guidelines.

Guidelines impact:

* Diagnosis no longer clinical, only by CDC positive surveillance
blood test or EM rash.
* Chronic disease will increase since 50% of
Lyme cases will be missed.
* Insurance companies have basis to deny
coverage for all treatment for chronic disease.
* State medical
boards have strong basis to attack our doctors.
* Family services
have strong basis for custody cases.
* School districts have strong
basis for not addressing special needs of students with chronic Lyme.

Rule by a few, most treat little if any Lyme disease:
14 IDSA committee members created these new guidelines.
14 IDSA committee members and the IDSA Board were the only ones to vote
& approve guidelines.
Patients and treating physicians were denied input into guidelines.
This small group holds our health and lives in its hands.

Where is the accountability?
We need to make them take responsibility
We need to hold them accountable
We need to let the world know what they are doing and why

New York Medical College/Westchester Medical Center is home to three of
the committee members

We need to let them know we will not quietly tolerate them harboring
this group

We need everyone to participate in this protest rally. Numbers count.
Bring family and friends if possible. If you cannot go, try to get
someone to go to represent you.

Those too far away to attend will be given other tasks (see website).
Print out and distribute attached flyers at your local doctor's
offices, grocery stores, libraries and any place that provides a
community bulletin board.

Media event notice to be sent shortly.

See you there.

Lyme Rights Protest Group
www.Lymenews.org <http://www.lymerightsrally.org/> Link to clean pdf
copy of letter ==>
<http://lymenews.org/2006-11-12Mass_e-mail_Letter.pdf>

PATIENTS WILL FIGHT BACK

[Non-text portions of this message have been removed]

[blimeyitslymie]

Time to Rally (November 30)
Posted by: "Rose" toil_for_lyme@yahoo.com toil_for_lyme

Sun Nov 26, 2006 10:33 am (PST)

The following excerpt from the IDSA guidelines should help
demonstrate to those chronically suffering from tick-borne illnesses
why we need to make our voices heard at the IDSA protest rally on
November 30: "In many patients, posttreatment symptoms appear to be
more related to the aches and pains of daily living rather than to
either Lyme disease or a tickborne coinfection. "

Your attendance is needed on Thursday to make this rally successful.

TRANSPORTATION TO RALLY:

Due to the need for a large turnout, organizers from various states
have arranged transportation. For the latest on transportation and
other protest details, please visit the protest website at
http://www.lymenews.org.

Transportation is being arranged from various points in MD, DE, NY,
NJ, MA and surrounding states. Transportation funding assistance is
available for those who would like to attend but cannot afford to.

* For transportation from MD, DE and S. NJ , cost is $25 or free.
Contact: LymePA@LymePA.org

* For transportation from MA, with possible pick-ups in states along
with way, contact Noreen: noreenflanagan@aol.com

* For a ride from Dutchess County , NY , contact Pat: Lymey2@aol.com

* For information on public transportation:

http://lymenews.org/html/public_transportation.html

* For directions, see:

http://lymenews. org/html/ directions. html

+++

To let the protest organizers know you will be attending (full name
not required):

http://kliman.org/tinc?key=F5F1Oyn3&formname=People

If you have any questions about attending, please do not respond to
this email. Instead, contact LymeRides@gmail.com or Lmmccabe@hvc.
rr.com. Thanks for your interest!

[blimeyitslymie]

CALL TO ACTION #7 (December 20)
from Pat Smith, President, Lyme Disease Association, Inc. (LDA)

Happy Holidays to All from LDA!

NEW! ACTION NEEDED
All groups: The LDA has adopted the following resolution and we ask that you adopt it at your next meeting. Change only using your group name and date in the Resolved clause. Support groups can adopt this, too. The group president, chairperson, director, or leader should put his/her name under a clean copy of the resolution you adopt and send the LDA the adopted copy by email to Lymeliter@aol. com. We will publicly use these resolutions in the national campaign to get these guidelines revoked.

RESOLUTION of the LDA

Whereas, the IDSA guidelines severely restrict clinical judgment;
Whereas, the IDSA guidelines deny the existence of chronic Lyme disease;
Whereas, the IDSA guidelines are punitive in nature and restrict the use of entire classes of antibiotics, combinations of antibiotics, long-term treatment, pulsed dosing, alternative treatments, even supplements for any manifestation of Lyme disease, thus precluding all viable treatment options for patients with chronic Lyme disease; and
Whereas, the restrictive IDSA guidelines will prevent patients from being diagnosed, treated, reimbursed for treatment, and will open treating physicians to medical board actions,
Therefore, Be It Resolved That the Board of Direction of the Lyme Disease Association, Inc. adopts this resolution at its regularly scheduled board meeting on this 13TH day of December, 2006, calling for the revocation of the Infectious Diseases Society of America (IDSA) guidelines.
Pat Smith, President


FOLLOW_UP OF LAST ACTION from Lyme Rights
Action: Those who sent Letters to the Editor to the Journal News (NY) in response to the Wormser article on the guidelines, if your letter was not published, please send a copy of your letter to Lmmccabe@hvc.rr.com from Lyme Rights with a note that it may be posted on the Lymenews.org website.

POST RALLY UPDATE & CONTINUING ACTION NEEDED
Followup: The following stations picked up the TV story we had produced on the guidelines/rally:
DISH Network (NET), Detroit (WPXD, PAX), Portland OR (KPXG, PAX), Indianapolis (WIPX, PAX), Grand Rapids-Kalamazoo- B.CR (WZPX, IND), Birmingham (Ann & Tusc) (WPHX PAX), Louisville (WBNA, PAX), Des Moines-Ames (KFPX, PAX), Cedar Rapids-WTRLO- IWC&DU (KGAN, CBS), Salisbury (WMDT, ABC).

Continuing Action: The short piece about the guidelines (produced by DWJ television for LDA, affiliates, ILADS) which includes rally clips is still available for all TV stations.
? Call your TV stations today. If they have access to new TV technology, Pathfire Digital Feed, tell them they can go to the site and plug in Lyme and they will be able to digitally access the story
? If the TV station does not have access to Pathfire, ONLY your TV station can call DWJ Television at 800 766 1711 ext. 239 (Maureen) or ext. 227 (Brian) to get a copy shipped to the TV station or to have any technical questions answered about Pathfire.


UPDATES: ONGOING ACTIONS!
LDA petition, over 20,000 signers! Keep getting more people to sign. All signatures must be entered online to be accepted. If you are entering someone's signature, they must have first physically signed a hard copy which you then send to LDA for its files with a note that you have entered it online already. We will not enter any un entered names that are mailed to us, we do not have the staff to do that unfortunately.
Those patients already impacted by new guidelines, a form was sent out online for you to fill out. Thanks to those who have already responded, and if you still want to respond, please email Lymeliter@aol.com for the form. You must have been denied services after Oct 2, 2006 with the Guidelines used as basis.

Pat Smith, President
Lyme Disease Association, Inc.
PO Box 1438
Jackson, NJ 08527
888-366-6611 information line
732 938-7215 fax
www.LymeDiseaseAssociation.org