LymeNet Newsletter Volume 3 Issue 13

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 <[email protected]>

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.

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II. LDF: LDF Announces Chronic Lyme Disease Therapeutic Trials ---------------------------------------------------------------- Sender: The Lyme Disease Foundation <[email protected]>

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.

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