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Volume: 3
Issue: 13
Date: 11-Aug-95


Table of Contents:

I.    LDF: A Call For Action
II.   LDF: LDF Announces Chronic Lyme Disease Therapeutic Trials
III.  About The LymeNet Newsletter


Newsletter:

***********************************************************************
*                  The National Lyme Disease Network                  *
*                         LymeNet Newsletter                          *
***********************************************************************


IDX#                Volume 3 - Number 13 - 8/11/95
IDX#                            INDEX
IDX#                SPECIAL LDF INFORMATIONAL ISSUE
IDX#
IDX#  I.    LDF: A Call For Action
IDX#  II.   LDF: LDF Announces Chronic Lyme Disease Therapeutic Trials
IDX#  III.  About The LymeNet Newsletter
IDX#




I.    LDF: A Call For Action
------------------------------------------------------
Sender: The Lyme Disease Foundation <lyme_fnd@aol.com>


Please join us Saturday, August 19 at the Sheraton Stamford Hotel in
Stamford, Connecticut to discuss important topics that are currently
affecting the Lyme disease community.  The meeting will take place
from 10:30 am until 12 noon in the America Room.  We need your input.
Only together will our voices be heard!


MEETING AGENDA

10:30 am   Welcome Address & Current Status of Lyme Disease (LD)
          Thomas Forschner, MBA, CPA, Executive Director, Lyme
            Disease Foundation


10:40 am   Topic: Obstacles Faced By Physicians Who Treat LD Victims
          Dr. Leslie Fein and/or Dr. David Fein of West Caldwell, NJ


10:55 am   Topic: Lyme Disease Legislation, Legal Issues & Insurance
          Ira Maurer JD, Elkind, Flynn & Maurer, NY, NY
          Karen Vanderhoof-Forschner, MBA, CPCU, CLU, Chair, Board of
            Directors, Lyme Disease Foundation


11:10 am   Topic: Getting The Word Out: Community Outreach & The Media
          Douglas S. Dodge, Writer, Guilford, CT


11:25 am   Topic: Fundraising
          Thomas Forschner, MBA, CPA, Executive Director, Lyme
            Disease Foundation
          Linda Stevens, Volunteer, Lyme Disease Foundation


11:40 am   Topic: The Urgent Need For LD Research
          Martina Ziska, MD, Medical Director, Lyme Disease Foundation


11:55 am   Closing Statements
          Thomas Forschner, MBA, CPA, Executive Director, Lyme
            Disease Foundation


Please call 203-525-2000 to RSVP by August 16 so an informational
packet will be reserved in your name.



=====*=====


II.   LDF: LDF Announces Chronic Lyme Disease Therapeutic Trials  
----------------------------------------------------------------
Sender: The Lyme Disease Foundation <lyme_fnd@aol.com>


Call for Financial Support !

There are no other treatment trials for chronic Lyme disease in the
world and none are planned within the next two years! This is the only
study that will focus on the issue that is at the center of the
international Lyme disease debate. The good health of all chronic Lyme
disease patients depends on the results of this study ... Please
encourage everyone you know to donate to make this project a reality!


OVERVIEW OF THE STUDY

  The Lyme Disease Foundation is pleased to announce the preparation
of clinical trials to evaluate the efficacy of antibiotics for chronic
Lyme disease (LD). This will be done in a prospective randomized
double-blinded placebo-controlled multi-site study.


  The subject of the study will be:
  1. Comparison of the efficacy of long duration (3-4 months) vs.
     short duration (1 month) therapy
  2. Comparison of the efficacy of IV antibiotics (e.g. ceftriaxone)
     vs. oral therapy (e.g. Doxycycline)


SIGNIFICANCE OF THE STUDY

  There is great controversy surrounding the persistency of signs and
symptoms in patients with Lyme disease. Some physicians believe that
the continuing problems are a result of a patient's immune system
being overactive and therefore the extended antibiotic treatment is
not justified. A second group of physicians and researchers, pointing
to the numerous published articles on the persistency of Bb despite 4
-6 weeks of antibiotic treatment, argue that the continuing symptoms
are due to persistency of infection - requiring longer courses of
antibiotics to kill all of the bacteria and return the patients to
prior-good health.


  There has been no study evaluating the efficacy of antibiotic
treatment in chronic Lyme disease. The results of this study will
significantly advance the approach to the treatment of LD patients. If
a longer treatment period is more beneficial than 1 month of
treatment, then patients and doctors will have the first objective
information needed to make this a standard recommendation. However, if
patients with short-term IV treatment do better than those with long
term treatment then this study will show the impracticality and
expense involved with long-term treatment. And, if oral therapy is as
effective as IV therapy, then more expensive therapy can be avoided.


  The study design is being prepared by the planning/executive
committee, consisting of the study chairman S. Donta, M.D., (Boston
University Hospital), the study cochairman M. Ziska, M.D. (Lyme
Disease Foundation), R. C. Tilton, Ph.D. (North American Laboratory
Group), T. Strickland, M.D. (Johns Hopkins School of Public Health),
B. Fallon, M.D. (Columbia University), J. Nowakowski, M. D. (New York
College of Medicine), H. Pastrides, Ph.D. (University of Massachusetts
Biostatistical Unit) and A. Kadlec-Donta (University of Massachusetts
Biostatistical Unit). The study could potentially  lead to the first
FDA approved drugs for treatment of Lyme disease.


STUDY BACKGROUND

  There appears to be a discrepancy between what is being promoted by
some physicians as a "curative" treatment for LD and what many
practicing physicians have experienced. It is generally agreed that 2-
4 weeks of therapy are probably successful for most patients with the
earliest manifestation of Lyme disease (LD), i.e. the erythema migrans
rash. But, despite the similar recommendation by several authors of 2-
4 weeks of antibiotic therapy for later manifestations, (e.g.
arthralgias, paresthesias, cognitive dysfunction, fatigue) other
physicians claim that their experience shows that longer courses of
antibiotic therapy are needed to effect significant improvement and
symptom-free status. The only way to validate this observation is to
execute a randomized controlled study.


STUDY RATIONALE

  The major hypothesis to be tested in this study is whether or not  
long courses of therapy (i.e. 3-4 months) are more beneficial in the
treatment of chronic LD than a short (4 week) course of therapy. The
rationale for the 3-4 month duration of therapy derives from a
physician survey, and from previous observations of others that 2/3 of
patients become symptom-free with a 3-month regimen. It seems
reasonable to begin these studies using a 3-4 month course as "long"
therapy.


  The basis for this hypotheses derives from two sources:
  * One is the very long doubling time for the causative agent,
    Borrelia burgdorferi, which predicts that not all organisms will
    be susceptible to antibiotic effects over a 2-4 week period of
    time. B. burgdorferi is the slowest growing bacterium, in vitro,
    second to mycobacterium tuberculosis. By similar analogy, the
    reason that 6 months or more are needed to treat tuberculosis is
    not that the anti-tubercular agents are relatively ineffective,
    but that not all tubercle bacilli are metabolically active and
    susceptible to the antibiotics over a shorter period of time.
    Many antibiotics have excellent activity against the Lyme
    borrelia in vitro, but their activity in vivo may not parallel
    their in vitro activity, perhaps because a longer duration of
    treatment is needed.
  * The second support for this hypothesis is from uncontrolled
    observations by others, and our preliminary observations that 3

    months or more of therapy is successful, whereas lesser durations
    of therapy are not. Despite these observations and rationale,
    however, only a controlled trial will prove or disprove the
    hypothesis.


  A secondary hypothesis is that oral therapy is equally efficacious
as IV therapy, for people with non-acute disease. The rationale for
comparing an  IV antibiotic with an oral one is to address the debate
that an effective drug that crosses the blood brain barrier is more
effective for CNS symptoms than is a drug that crosses the barrier
less well. This might not be the case for chronic symptoms, where
meninges (brain covers) are likely not to be inflamed.  Some physicians
have made an observation that a longer term oral antibiotic therapy
controls the symptoms of chronic Lyme disease as well as IV regimens
do.


  The decision as to which drugs will be tested is not final at this
point. Under consideration is Doxycycline for oral regimen and a
ceftriaxone for IV regimen.


For more information about this study, contact the Lyme Disease
Foundation at 203-525-2000.



=====*=====


III.  ABOUT THE LYMENET NEWSLETTER
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