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From the LymeLight Newsletter of
the Lyme Disease Foundation

The controversies surrounding Lyme Disease diagnosis and treatment and why it is not uncommon for patients to experience persistent symptoms despite receiving conventional" (short-term) antibiotic therapy for Lyme disease.

"Randomized controlled studies of treatment of patients who remain unwell after standard courses of antibiotic therapy for Lyme disease are in progress. To date, there are no convincing published data that repeated or prolonged courses of either oral or iv antimicrobial therapy are affective for such patients. The consensus of the Infectious Disease Society of America (IDSA) expert-panel members is that there is insufficient evidence to regard "chronic Lyme disease" as a separate diagnostic entity."

So reads the most disturbing statement in the latest Lyme disease diagnostic and treatment protocol, formulated by the Infectious Disease Society of America (IDSA) and published in the September issue of Clinical and Infectious Diseases (2000; 31:1-14). Not surprisingly, the protocol dismisses the existence of chronic Lyme and provides clinicians with a virtual "four weeks cures all" protocol. The LDF expected the contents of the protocol after it discovered internal National Institutes of Health (NIH) documents that confirm the IDSA protocol was coordinated with a CDC-funded protocol to ensure they were identical. Another unsurprising aspect of the protocol is that it does not disclose IDSA committee members' conflicts-of-interest, as some committee members consult for insurance companies and Health Maintenance Organizations.

The IDSA's chronic Lyme disease (LD) statement is especially troubling because it comes during a time when physicians who recognize and aggressively treat late-stage LD are being charged by state licensing boards with overdiagnosis and overtreatment of the disease. For such doctors the protocol adds another "authoritative" document dictating "appropriate management" of a disease in which treatment failure can occur in any stage and no test can definitively diagnose or distinguish active from past infection. Adding further confusion to doctors trying to responsibly help patients is that no consensus has been reached about the clinical spectrum of LD, which the Centers for Disease Prevention and Control (CDC) states is a clinical diagnosis not to be ruled out based on negative tests.

"The implications of the guidelines are chilling," said Kenneth Liegner, M.D., a LD specialist from Armonk, NY, an area hyperendemic for Lyme disease. "They place physicians who treat beyond [IDSA] parameters in an extremely defensive position." Sam Donta, MD a Boston University Hospital infectious disease specialist, has already experienced the impact IDSA's statement is having on other clinicians. "Patients have already told me doctors are telling them there is no such thing as chronic Lyme disease," he said.

Donta, who like Liegner treats late-stage LD patients from around the country with longer-term antibiotic therapy, said he too was stunned that the Society could come to such a conclusion, especially since the National Institutes of Health (NIH) believes in chronic LD enough to study it.

Many physicians and researchers voice displeasure that since Lyme was supposedly "identified" in and around Lyme, Connecticut in 1975 by rheumatologist and IDSA committee member Allen Steere (a medical/insurance consultant), he and a few of his colleagues have become crowned "leading authorities" on LD. They say the approach they and the CDC take studying the disease continues today: minimize medical costs associated with the disease by downplaying its seriousness and defining it in the narrowest terms possible. Such an approach limits patient access to tests, reduces the official number of patients reported to have the disease, and reduces treatment costs, they say.

Initially Steere believed LD was a viral arthritis that affected only children, its symptoms were limited to arthritic conditions, and the disease eventually went away on its own. Southeastern Connecticut shoreline towns were thought to be the only place in the country where one was at-risk for the disease. It was also believed neurological manifestations of LD, common in Europe, did not occur with US strains of the LD bacterium, Borrelia burgdorferi, (Bb).

As science evolved, Steere and his colleagues, most of which continue to receive large government grants to study the disease, were slow to acknowledge Lyme is often a multisystemic disease. As it became apparent that symptoms often did not disappear on their own, they acknowledged antibiotic treatment was sometimes necessary to eradicate the Lyme bacteria. They steadfastly maintain, however, that short-course antibiotic therapy is highly curative, seronegative disease is rare, and patients who remain symptomatic after treatment suffer from misdiagnosis or "post Lyme syndrome", which attributes persisting symptoms to past, not active infection.

While initial conclusions about the disease have been modified, their narrow definition of the disease allows the most conservative conclusions relative to diagnosis and treatment to be made. Patients in late disease with severe neurologic symptoms, which are the most problematic to diagnose and difficult to cure, rarely meet the narrow CDC surveillance criteria (e.g. swollen joint(s) and positive two-tier tests) used as inclusion criteria for research studies. As a result, a large void in Lyme research exists.

Testimony by IDSA committee member/insurance consultant Raymond Dattwyler, MD during a 1994 Food and Drug Administration (FDA) meeting on the Lyme vaccine reveal enough gray areas in scientists' understanding of the disease to suggest standardization of diagnosis and treatment of LD is not yet possible. Nationally-based treatment trials of erythema migrans, Dattwyler said, may suggest regional differences in patients' symptoms and response to antibiotic therapy due to many different strains of Bb found throughout the U.S. Dattwyler also testified that patients who mount a weak immune response to the disease tend to have worse disease and a greater chance of treatment failure than do those who mount a vigorous immune response.

In addition, Dr. Dattwyler echoed the consensus among experts concerning the relationship between the LD bacteria and how it affects humans. "I don't think we have fully delineated all the various clinical manifestations associated with this infection," he said. Several times throughout his testimony Dattwyler repeated that sentiment.

Dr. Liegner has concerns that suggest IDSA bias against the existence of chronic LD. "It's amazing that the Committee ignored piles of published case studies detailing chronic Lyme because they're not double-blinded peer-reviewed studies," he said. Liegner went on to echo the consensus among he and his colleagues: In lieu of the absence of such research and disagreement among experts over the etiology and clinical spectrum of the disease, there are no "evidence-based" experts qualified to determine appropriate standards of care for LD. Therefore, Liegner said, empirical treatment, or treatment based on patient response, should be the standard of care.

Dr. Liegner also expressed concern that out of 99 studies cited in the protocol, only two examines chronic LD. One cited study by Dr. Steere, "Chronic neurologic manifestations of Lyme disease" (N Engl J Med 1990; 323:1438-44) evaluated the outcomes of patients with late neurological LD symptoms when treated with iv ceftriaxone (2 grams daily for two weeks). Of 27 adult patients, 17 (63%) of patients had "uncomplicated improvement." 6 (22%) had improvement and then relapsed and 4 (15%) had no change in their condition. Regardless of this study's 66% "uncomplicated improvement" rate, IDSA recommends treating late neuroborreliosis with 2-4 weeks of ceftriaxone. Guidelines state "response to treatment may be slow and incomplete." Unless relapse is shown by "reliable, objective measures" repeat therapy is not recommended.

An abstract presented by IDSA committee member Dr. Dattwyler at the VII International Congress on Lyme Borreliosis in 1996 revealed similar statistics. That study evaluated the effectiveness of intravenous orintramuscular injections of ceftriaxone, 2 grams daily, for 2 versus 4 weeks. Patients in the study had to have objective evidence of a usculoskeletal, neurologic or dermatologic disorder compatible with the diagnosis of LD and positive ELISA and Western blot tests.

The abstract reported clinical cure rates of 76% for patients treated for 14-days and 70% for those treated with 28-days. While the 28-day group had a lower efficacy rate, patients in this group were "more severely ill" than those treated for two-weeks. (No data concerning patients' specific immune response was included.)

TO READ THE REST OF THIS INTERESTING POSITION PLEASE LINK TO THE LYME DISEASE FOUNDATION SITE AT: www.lyme.org/lymelight/trtcontrov.html

They have been very aggressive in listening to thousands of patients who feel their terse antibiotic treatment was not a successful treatment. They appear to be very good at listening, education and legislation for full treatment of Lyme Disease and other co-infections.

Some samples of their work is listed below:

The LDF has conducted 20 scientific conferences to date, including 16 International Scientific Conferences. These medically-accredited multi-day conferences unite healthcare professionals and researchers from a variety of disciplines to discuss the latest findings and patient management techniques. The programs provide a forum where multiple disciplines engage in vigorous debate and new collaborations are forged. These symposia have speakers presenting the latest research, poster presenters, networking receptions, exhibitor displays, and a conference compendium. Yearly attendance is several hundred people from around the world, with about 80% being healthcare professionals. Interaction with patients and the public helps researchers better understand how their work can improve the public health. Conference participants include officials from government agencies (e.g. National Institutes of Health, Centers for Disease Control & Prevention, Food & Drug Administration, Armed Forces), state health departments (e.g. TX, IL, CT, NY, NJ), prestigious medical schools (e.g. Columbia Univ., Boston Univ., Univ. of California, Yale, New England Medical Center) and research facilities (e.g. Brookhaven National Labs, Tulane Primate Center). These presenters, key players in tick-borne research, will one day provide permanent solutions to tick-borne disorders.

CME Internet Conference Summaries

Several LDF's International Scientific Conference presentation summaries have been available for continuing medical education (CME) credits on Medscape's website. These presentations receive about 150,000 page views each year (60% medical, 40% consumers) and have awarded 1,000 additional continuing medical education credits.

Conference History

(click on the conference for a summary (if available))

2004 - One-day Forum, The Legal Side of Lyme, Windosor, Ct.

2003 - 16th Int'l Scientific/Medical Conference, Hartford, CT

2002 - 15th Int'l Scientific/Medical Conference, Farmington, CT
2001 - 14th Int'l Scientific/Medical Conference, Farmington, CT
2000 - 13th Int'l Scientific/Medical Conference, Farmington, CT
1999 - 12th Int'l Scientific Conference, New York City, NY
1998 - 11th Int'l Scientific Conference on LD and Other Spirochetal & Tick-Borne Disorders, New York City, NY
- Medical Teleconference on LD Diagnosis & Treatment, Chicago, IL
1997 - 10th Int'l Scientific Conference on Lyme Disease & other Tick-borne Disorders: State of the Art, National Institutes of Health, Bethesda, MD
1996 - 9th Annual Int'l Conference on Lyme and other Tick-borne Disorders Chronic LD: Basic Science & Clinical Approaches, Boston, MA
1995 - 8th Int'l Scientific Conference on Lyme Borreliosis and other Spirochetal and Tick-borne Diseases: Emphasis on Mechanisms of Persistency, Vancouver, British Columbia
1994 - 7th Int'l Scientific Conference on LD: Emphasis on Neurologic Manifestations, Stamford, CT
1993 - href="http://www.lyme.org/conferences/93_abstract.html">6th Int'l Scientific Conf. on LD & other Tick-borne Diseases, Atlantic City, NJ
1992 - 5th Int'l Scientific Conference on LD: State of the Art, Stamford, CT

Lyme Disease Diagnosis and Treatment, Novi, MI
1991 - 4th Int'l Scientific Medical Conference, Los Angeles, CA
- Lyme Borreliosis Prevention: Training the Educators, Shelter Island, NY
1990 - 3rd Lyme Borreliosis Scientific Symposium, Orlando, FL
1989 - 1st LD Scientific Conference, Austin, TX
- 2nd Int'l Scientific Conference. Borreliosis West, Oakland, CA
1988 - Lyme Disease: The Leading Edge, Hartford, CT
- Multifaceted Aspects of LD, Tarrytown, NY

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This 3-hour conference, with the keynote by Willy Burgdorfer, PhD, MD (discoverer of the Lyme disease bacterium), covers the key areas of diagnosis, testing, treatment, and response of public health officials.

Mark Schmidt, Assistant Director, Illinois Department of Public Health states, "This conference should be of interest to all healthcare providers. It is clear that we will see more of this emerging infectious disease in the future because not only has B. burgdorferi has been found in Illinois, but also many residents travel to other endemic areas."

It is cosponsored by the Illinois Department of Health, Cook County Department of Health, and the Illinois Academy of Family Physicians, received continuing medical education credits from the American Academy of Family Physicians.

SCIENTIFIC EDUCATIONAL MATERIAL

To supplement its conferences, the LDF provides additional scientific material to educate healthcare professionals. This includes the LDF's Journal of Spirochetal and Tick-Borne Disorders, scientific slide shows, videos, website, and packets of scientific articles.

Clinical Infectious Disease: Chronic Lyme Disease Supplement - A special issue with scientific articles covering a variety of medical issues by presenters at a LDF Scientific Conference.

Journal of Spirochetal & Tick-Borne Diseases - Quarterly peer reviewed journal devoted to all aspects of spirochetal diseases. Published since 1994.

Scientific Conference Compendium - Bound version of presentation abstracts and articles from the latest LDF Conference.

BROCHURES, VIDEOS, SLIDES, POSTERS

LD Scientific Slide Show - Slides with script. Pictures of Bb spirochete, ticks, rashes, prevention techniques, and more.

LD Diagnostic Picture Poster Set - Scientific and general information.

Satellite Medical Conference - Video covering diagnosis, testing, treatment, and the public health department response. See above.

LD Diagnosis & Treatment - Video of physicians discussing the challenges of LD diagnosis and treatment.

Self-Help Program - Video-based program designed to help a person establish and conduct a Self-Help (support) group. Also included are an instruction manual, posters, brochure masters, and brochures.

PACKETS

LD Scientific Packet - Diagnostic poster & copies of scientific articles.

LD Chronic Packet - Copies of a variety of articles regarding chronic Lyme disease. Includes scientific Diagnostic poster.

Tick-Borne Disorder Packet - Includes brochures, medical articles, and advice for patients experiencing insurance treatment denials.



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