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Volume: 1
Issue: 12
Date: 03-Jun-93


Table of Contents:

NEWS: Upstate NY County Declared Endemic
ANNOUNCEMENT: Support Group in Montgomery County, PA
HARTFORD COURANT: Victim of Lyme disease settles malpractice suit
SPECIAL SECTION: LDF Conference Summary - part 1
(with Consensus Diagnostic Categories and Treatment Guidelines)


Newsletter:

*****************************************************************************
*                  Lyme Disease Electronic Mail Network                     *
*                          LymeNet Newsletter                               *
*****************************************************************************
                     Volume 1 - Number 12 - 6/03/93


I.   Introduction
II.  Announcements
III. News from the wires
IV.  ** Special ** LDF Conference Summary
V.   Jargon Index
VI.  How to Subscribe, Contribute and Get Back Issues



I. ***** INTRODUCTION *****

In this issue, Dr. Lloyd Miller reports from the 6th Annual Lyme Disease
Scientific Conference that took place last month in Atlantic City, NJ.
He has compiled a series of notes that provide us with a synopsis of the
information presented at the conference.  Thanks to Dr. Miller for submitting
this information for publication.


Dr. Miller also informs us that Albany County, NY, has been declared endemic.
Such declarations are important, as they warn residents of the risks and add
credibility to patients who are seeking treatment for LD.


A new support group has formed in Montgomery County, PA -- details are
printed below.


Finally, we learn of Connecticut's first publicly announced malpractice
settlement against a doctor who failed to recognize LD.  I'm keeping a
close eye on the legal ramifications of LD as they may have an effect on
how doctors treat (or fail to treat) patients.


-Marc.

II. ***** ANNOUNCEMENTS *****

Sender: "Lloyd E. Miller,DVM" <71053.2727@compuserve.com>
Subject: Upstate NY County Declared Endemic
Date: May 26, 1993


Albany County, New York has been declared *endemic* for Lyme disease.
The New York State Health Department has identified infected ticks in the
county.  Many of us up here have felt there have been infected ticks here
for a long time.  This is a very important announcement because it validates
what we have been observing -- that the ticks and the disease have been
spreading into upstate New York State.  Dr. Dennis White, the Director of the
Tick-Borne Disease Institute, in his statement emphasized that although
they have only identified infected ticks in Albany County, so far, that all
residents of the area and surrounding counties must take notice because
it is likely infected ticks already are present.


The listed reference although a couple of years old is excellent and highly
recommended to New York State residents. An update of the article would prove
very interesting.  

  White DJ,Chang H et al: The geographic spread and temporal increase of the
Lyme disease epidemic. Journal of the American Medical Society
1991;266(9):1230-1236.


=====*=====

A new support group has formed in south-eastern Pennsylvania.  This SG meets
at the Holy Trinity Lutheran Church in Abington (Montgomery County) on a
monthly basis.  For more information, contact:
   Phil Rudolph   215-721-9424 (W)   215-659-0718 (H)
 Barbara Caruso   215-991-8534 (W)   215-627-8135 (H)  



III. ***** NEWS FROM THE WIRES *****

SOURCE: The Hartford Courant [Connecticut]
DATE: May 18, 1993, A Edition
HEADLINE: Victim of Lyme disease settles malpractice suit;
Victim of Lyme disease settles suit
BYLINE: LYNNE TUOHY; Courant Staff Writer


An Old Saybrook woman has secured what may be the state's first medical
malpractice settlement against doctors for misdiagnosis of Lyme disease,
which has left the 30-year-old almost totally disabled.


Deborah Heiney suffers chronic pain from neurological damage caused by the
disease and will receive $350,000 from the insurance company representing
Dr. Richard O. Gritzmacher and the late Dr. Donald E. Cook, Heiney's lawyer
said Monday.


Emmet L. Cosgrove of New London filed a lawsuit on Heiney's behalf three
years ago in Middlesex Superior Court, alleging she is permanently disabled
from complications of late-stage Lyme disease because of the negligence of
the Old Saybrook doctors.


Laura Frankel, a lawyer with Updike, Kelly Spellacy, the firm representing
the doctors and their insurance company, confirmed that a settlement had
been reached, but declined to discuss any of its provisions.


In the summer of 1987, Heiney sought treatment from Gritzmacher and Cook for
severe headaches, muscle aches and flu-like symptoms.  Cosgrove said the
doctors first diagnosed her as having the flu and prescribed pain medication.
They later concluded she had post-viral encephalitis and gave her an anti-
inflammatory drug, Cosgrove said.


Her condition did not improve, and Heiney consulted an orthopedic specialist
in July 1988 -- 13 months after her first visit to Gritzmacher and Cook.
Tests done by the specialist revealed the Lyme disease, concentrated in her
spinal fluid.  Intravenous antibiotic therapy failed to eradicate the
damage done by the disease, which had migrated to her brain, Cosgrove said.


The disease impaired Heiney's memory and now causes chronic pain that
often forces her to use a wheelchair.  She is unable to work, Cosgrove said.


"There is always a high degree of pain, but there are times when it becomes
debilitating," Cosgrove said.  "It is intermittent in that sense, but not in
the sense that there are days she feels great.


"It's very frightening.  It can happen pretty quickly," Cosgrove said of the
permanent damage that Lyme disease can cause.  "If it's not picked up, there
can be very serious consequences."


Cosgrove said Heiney's doctors could not be faulted for their first
misdiagnosis of her symptoms in June 1987, but should have suspected Lyme
disease when her symptoms, which Cosgrove called "classic," persisted.  She
was a prime candidate for the disease,  living as she did then on the edge
of a salt marsh, owning several pets that could have been carriers of the
bacteria -- laden deer ticks that transmit the disease to humans, and
exhibiting her symptoms at the height of the Lyme disease season, Cosgrove
said.


In addition, the state Department of Health Services sent notices to all
Connecticut doctors in June 1987 requiring them to report any new cases of
Lyme disease within 24 hours.  The notices should have heightened awareness,
Cosgrove said.


Lyme disease was first identified by a Yale University physician in 1975
in Lyme and Old  Lyme.  Cosgrove said Heiney did not experience the "bull's
eye" rash that characterizes the onset of the disease in more than half of
Lyme disease sufferers, but she had virtually all the other symptoms,
including the persistent muscle ache and other flu-like symptoms.


   Cosgrove said he could find no other Lyme disease malpractice settlement
on record in the state.



IV. ***** SPECIAL LDF CONFERENCE SUMMARY ******

Sender: "Lloyd E. Miller,DVM" <71053.2727@compuserve.com>
Subject: 6th Annual Lyme Disease Scientific Conference


NOTES AND OTHER INFORMATION FROM THE 6th ANNUAL LYME DISEASE SCIENTIFIC
CONFERENCE  --  ATLANTIC CITY, NEW JERSEY  --  MAY 5th - 6th, 1993


Every effort has been made to be accurate as possible -- corrections,
additions, clarifications and comments on anything in the notes are welcome.


Items bracketed by >*< are my own comments - LEM  >*<

The title of the paper is given first followed by the primary authors name
followed by excerpts from the authors abstract and notes taken during his
presentation.


Lloyd E. Miller,DVM  May 1993
------------------------------------------------------------------------------


1993 LYME DISEASE DIAGNOSTIC CATEGORIES

Consensus opinion of 50 physician panel in association with the Lyme Disease
Foundation - Tolland, Connecticut


EARLY LOCALIZED

 Single Erythema Migrans rash per bite and no other symptoms, with no signs
or symptoms that disseminated disease could be present.


DISSEMINATED DISEASE
 A. EARLY DISSEMINATED
   *  General - Fever, flu-like symptoms, lymphadenopathy.
   *  Neurologic - severe headache, meningitis (aseptic), cranial neuritis,  
      radiculitis, meningioradiculitis (Bannwarth's), stroke.
   *  Dermatologic - Multiple lesions per bite, lymphocytomas.
   *  Muscular - Myalgias.
   *  Skeletal - Arthralgias.
   *  Ophthalomologic - conjunctivitis, ocular keratitis, uveitis,          
      chorioiditis, exudative retinal detachments, pars planitis,
      diplopia, neuroretinitis, optic neuritis.
 B. LATE DISSEMINATED
   *  General - Profound fatigue.
   *  Neurologic - Chronic encephalomyelitis, demyelinating-like syndromes,
      axonal polyneuropathies, cognitive and behavioral changes.
   *  Psychiatric
   *  Ophthalmologic - Optic atrophy
   *  Dermatologic - Acrodermatitis Chronica Atrophans
   *  Cardiac - Heart block, myocarditis, vasculitis
   *  Skeletal - Arthritis, asymmetric, pauciarticular, intermittent or      
      chronic


REFRACTORY DISEASE
 A. Persisting signs and symptoms responsive to additional therapy.
    Patient is responsive to additional antibiotic therapy and improves,
    the patient has a J-H reaction to additional therapy, or the patient's
    condition degenerates upon discontinuing antibiotic therapy.  Varying
    the antibiotic or method of administration may help.
 B. Persisting signs and symptoms not responsive to additional therapy.
    The patients signs and symptoms are in no way affected by use (despite
    varying antibiotic choice or method of administration) or lack of use
    of antibiotics.  Discontinue antibiotic use and move to supportive
    therapies.


>*< These classifications make more sense to me than the stage 1-2-3
descriptions of the past for they more closely describe what is happening.
They help validate for those patients with refractory disease their situation
-- no they really aren't crazy after all!!! >*<
-----------------------------------------------------------------------------


1993 LYME DISEASE TREATMENT CATEGORIES

Consensus opinion of 50 physician panel in association with the Lyme Disease
Foundation -- Tolland, Connecticut


EARLY LOCALIZED  (30 - 45 days)
 * Amoxicillin 1000 mg plus probenecid 500mg TID
 * Doxycycline 100 mg BID (not in pregnancy or children)
 * Minocin 1.5 mg per kg per day (not in pregnancy or children)
 * Ceftin 500 mg BID


DISSEMINATED DISEASE
 A. EARLY DISSEMINATED ( minimum of 6 weeks)
    * Amoxicillin 1000 mg plus probenecid 500 mg TID
    * Doxycycline 200 - 400 mg per day (not in pregnancy or children)
    * Minocin 200 - 400 mg per day  (not in pregnancy or children)
    * Azithromycin 250 - 500 mg per day
    * Clarithromycin 500 - 1000 mg per day
    * Ceftin 1500 mg per day
    * Use IV therapy if oral not producing a satisfactory response
 B. LATE DISSEMINATED (minimum of 6 - 8 weeks with option to extend)
   * Claforan 6 grams per day (2 grams TID)
   * Rocephin 2 grams daily
   * Penicillin G  20 - 25 million units per day
   * Ampicillin 4 - 6 grams per day (divided 4 times per day)


REFRACTORY DISEASE
 A. Persisting signs and symptoms responsive to antibiotic
   * Increase duration of treatment
   * Increase doses of antibiotics
   * Check peak and trough blood levels of antibiotic adjust dose
     accordingly
   * Change to different antibiotic
   * Change from oral to IV antibiotic
   * Consider continuous IV infusion of antibiotic
   * Consider combining antibiotics - use antibiotics from different
     classes
 B. Persisting signs and symptoms not responsive to antibiotic
   * Reassess patient
   * Supportive treatment based on symptoms - physical therapy, non-        
     steroidal anti-inflammatory drugs, muscle relaxants, antidepressants,        
     tricyclics, plaquenil, immunoglobins, synovectomy
   * Psychiatric support and evaluation
   * Continue testing as newer tests become available
   * Adjunctive treatment - B-vitamins, acidophilus - no alcohol
   * Consider retreatment if conditions change


NOTES:
   * Patients on long term oral antibiotic treatment should have monthly    
     follow-ups and laboratory tests.
   * Patients on long term IV antibiotics should have weekly laboratory    
     tests.
   * Laboratory tests to include as a minimum SMA 12 (including liver        
     function tests). Lytes, CBC with differential


>*< Note that this is a consensus opinion -- several antibiotics which have
been used in the past are not mentioned (e.g. Suprax) -- much longer term
antibiotic treatment is still practiced by many of the physicians on the panel
-- it is still important that treatment of each patient be individualized and
be a decision made by the patient and physician working together  -- no
combination therapies are mentioned in the consensus but it was clear from
comments made that several of the physicians do prescribe combination therapy
if he feels that the case warrants such treatment >*<
------------------------------------------------------------------------------


Conspecifity of Ixodes scapularis and Ixodes dammini
James H. Oliver, Jr., PhD


  Significance of determination that Ixodes dammini (Ix.d.) and Ixodes
scapularis (Ix.s.) are one in the same: Data from the North can be
extrapolated to the South -- helps to refute that "Lyme doesn't exist in the
South."  Crossing Ix.d. with Ix.s. produced all fertile ticks through third
generation.  However crossing Ix. pacificus with Ix.d produced all sterile
offspring in first generation.  Therefore, these are separate species.  Under
laboratory conditions the life cycle of Ix.d. and Ix.s. are the same and
they both have the same vector competence.
------------------------------------------------------------------------------


Evaluation of a human Lyme disease vaccine for safety and immunogenicity
John P. May, PhD


 Vaccine using OspA was effective in protecting mice by challenge by
injection.  Speaker described safety trials of the vaccine in people.
*This was not an efficacy trial.*  The vaccine was administered to healthy
volunteers from a non-endemic area.  Safety profile reported "no adverse
reactions what-so-ever."  There were some local reactions at the site of
injection which all resolved within 72 hours.  Two of the 36 had a fever of
99.5F which resolved within 24 hours.  Irritability, joint pain and headache
were infrequent.  A six month follow up of the safety study is about to be
conducted.  Conclusion drawn from the study was it is a very safe vaccine.
Preliminary results of vaccine in people using IgG response to the vaccine
showed a mild immune response to the first dose of the vaccine with a strong
immune response following the second dose four weeks later.  Growth
inhibition assay done by incubating B.b. in sera and Guinea pig complement
resulted in B.b. growth inhibition in the sera of those vaccinated with

both the adjuvanted and non-adjuvanted vaccine and no inhibition in those
vaccinated with a placebo.


A question was asked if the vaccine might be effective against B.b.
strains that do not contain OspA for which there was no current answer.


 >*< There was some concern expressed by some in attendance that the outer
surface proteins my produce immune-mediated adverse responses in people and
that OspA may be a poor vaccine candidate because of this possibility. It
was also expressed by many that they felt a human vaccine was still years
away.>*<
------------------------------------------------------------------------------


Symptoms based on physician specialty and geographic distribution: Similar or
differing presentations?
Irwin T. Vanderhoof, FSA, PhD, ACAS, CFA, CLU, BS


 No regional differences in presentation of Lyme disease were found by
diagnosing specialist or geographic region; recollection of tick bite or rash
vs no recollection;  or on results of serologic tests.  Presentations
essentially followed the same patterns and involved the same body systems in
the same proportions.
------------------------------------------------------------------------------


Interactions of B. burgdorferi with skin fibroblasts
Mark S. Klempner, MD


 Experiments were conducted to examine whether fibroblasts might provide a
protective niche for the spirochete.  Can spirochetes be isolated from
co-cultures with human fibroblasts after treatment with ceftriaxone?
Ceftriaxone does not enter fibroblasts.  Cultured Bb plus fibroblasts plus
ceftriaxone at 3 times minimum inhibitory concentration (MIC) and recovered
Bb from 26 of 26 cultures.  Also demonstrated recovery of Bb from infected
fibroblast co-cultures despite treatment of the cell cultures with > 10 times
the Minimum Bacteriacidal Concentration (MBC).  He showed that protection
required viable fibroblasts.  He also demonstrated that Bb was killed in the
growth medium so recovery was from the cells not outside the cells.  The
length of protection was "considerable" -- 14 days in ceftriaxone.  He also
clearly demonstrated the presence of whole Bb organisms inside the
fibroblasts.  Bb were inside the fibroblasts within 24 hours.  He showed
that Bb binds to and invades fibroblasts.  No sugars have been found that

inhibit Bb from binding to fibroblasts.  Monoclonal Antibodies to P41 or
P39 did not inhibit binding.  Fibroblasts in vitro did protect Bb from
antibiotic.
------------------------------------------------------------------------------


Extracellular components of Borrelia burgdorferi - possible role in the
pathogenesis of Lyme disease
Claude F. Garon, PhD


Hypothesis: Few spirochetes produce an enormous amount of vesicular
(extracellular) material which results in disease expression.  Bb appears
during periods of growth to shed membranous materials from its surface.
This material is found in infected ticks, human cultures, and in infected
animals.  It has not been found in uninfected ticks or animals.  This
material appears to be present wherever active growth of the organism is
taking place.  Whether this can be used to provide evidence of persistent
infection is not yet known.  It may be a useful marker for active infection
and/or treatment effectiveness.


Speculation: The vesicles on Bb become coated with antibody making it less
visible to the system: bind IgM tightly -- mechanism to avoid immune system?
The extracellular components are involved in the packaging and protection of
intact DNA molecules containing a few known and many unknown genes and gene
products.


They possess potent, non-specific mitogen activity which may cause an
inappropriate and non-effective stimulation of the immune system triggering
autoimmune disease components.


Any vaccine which contains any of these components has the potential to
produce autoimmune sequella.


Four outer surface proteins have now been identified - OspA, B, C, D
------------------------------------------------------------------------------


The immune response and its application toward diagnosis
Steven E. Schutzer, MD


As specific antibody may be found bound to an infectious agent, especially
early in the infection. the author's hypothesis was that this could be
happening in Lyme disease.  The predominance of antibody may be found bound
to the agent in an antigen-antibody or immune complex.  With current
antibody tests for a positive test there must be excess of antibody over
antigen.  Until there is an excess all antibody will be complexed.  
Serum immune complexes were isolated and dissociated from Lyme disease
patients fulfilling modified CDC criteria and controls.  Bb complexes were
found in 10 of 11 early cases, 55 of 56 symptomatic patients with Lyme
disease, 0 of 50 healthy controls, 2 of 50 with other disease including
those likely to have elevated levels of immune complexes, 13 of 13
persistently seronegative patients who had erythema migrans, 4 of 4 who
were also positive on t cell proliferation assay to Bb, and 0 of 8 patients
who had recovered.  In early acute cases complexes to IgM was the first
antibody to be detected.  The authors conclusion: this relatively simple

technique has potential to support or exclude a clinical diagnosis of
early as well as active Lyme disease.
------------------------------------------------------------------------------


Lyme disease, Abdominal pain and the gastrointestinal tract
Martin D. Fried, MD


Twelve children with clinical and laboratory evidence of Lyme disease were
evaluated.  Abdominal symptoms of Lyme disease can occur early; 6 to 12
months prior of diagnosis and antibiotic treatment.  GI symptoms may occur
before other symptoms.  Types of pain exhibited were: chest, epigastric,
periumbilical, left lower quadrant banding to the right, and vomiting.  In
these patients the disease involved 8 different organ systems and 9 of 12
had laboratory evidence of LD. An extensive rule out was conducted on these
patients. All had normal ultrasounds.


Endoscopic exam results: 9 of 12 had inflammation of either the stomach or
duodenum.  75% of the patients had gastrointestinal inflammation. 2 of 12
had spirochetes in duodenal mucosa. 1 of the 2 was seronegative.  
Lymphocytes and plasma cells were the predominant inflammatory cells.
Colonic biopsies were consistent with Crohn's disease.


Speculations of the etiology of the inflammation: excess stomach acid,
antibiotics (most patients had had no previous antibiotic treatment),
infection, histamine/prostaglandin release, immune response.


Treatment: Tagmet and Zantac were not particularly effective.  Omeprazole
(which stops stomach acid production) was administered for 2 months along
with antibiotics.  The pain improved but was not entirely eliminated.


Conclusion: gastritis and duodenitis occurs in children with Lyme disease
and abdominal pain.


>*< This is a significant paper. For several years Dr. Dorothy Pietrucha has
been reporting abdominal pain in pediatric patients (often quite severe )
which has been blamed on (confused with) possible GI ulceration, or in
females on gynecological problems. This paper convincingly demonstrates yet
another organ system that Lyme disease affects and Bb invades.  Over the
past three years I have heard many anecdotal reports that Lyme patients have
been diagnosed with inflammatory bowel disease and/or Crohn's disease. This
report helps to validate these reports. We should hope the same
investigations will be conducted in adults. >*<
------------------------------------------------------------------------------


Pediatric cardiac involvement with Lyme disease
Michael B. Alpert, MD, FAAP, FACC


Lyme carditis: literature reports 3:1  - male : female ; the author
believes it is the reverse.
 
10% of kids with Lyme have cardiac involvement


Electocardiogram abnormalities described were: first, second, and third
degree heart block, right bundle branch block, premature ventricular
contractions (seeing more an more of this ), abnormal polarization (inverted
T wave)
 
Symptoms: chest pain, palpitations, irregular heart beat, low heart rates


Chest pain from:  (1) costochondritis which isn't very responsive to
antiinflammatory treatment but does improve with antibiotic treatment; (2)
myocarditis which can be serious and cause death; (3) unexplained


Palpatation:  (1) supraventricular tachycardia which is not well controlled
unless Lyme is treated; (2) unexplained


Irregular heart beat:  (1) premature ventricular contractions; (2)
premature atrial contractions; (3) unexplained


Slow heart rate; (1) complete heart block; (2) sinus bradycardia
------------------------------------------------------------------------------


Evidence for rapid nervous system invasion by Borrelia burgdorferi
Patricia K. Coyle


Pseudotumor Cerebri seems to be age related - seen in children

Study of 25 patients  (serum and CSF) -- 12 female/13 male -- ages 15 - 80
-- 10 had completed antibiotic treatment -- length of illness = 1 day to 3
months 68% had EM, 16% Bell's palsy, 8% recollected tick bite associated
with headache and stiff neck, 4% meningitis, 4% acute polyradiculopathy


CSF contained OspA antigen in 36% and 72% had Borrelia specific immune
complexes.  All-in-all 88% of patients had either antibody, antigen or
immune complex in their CSF; in contrast only 17% had elevated intrathecal
production, 24% had elevated protein levels and 20% increased cell count.


Authors conclusion: Findings support early central nervous system invasion
by Borrelia burgdorferi.  Headache, in particular, is a suggestive symptom.
The CSF shows frequent abnormalities with regard to B. burgdorferi antigen
and specific complexes, but not with regard to routine studies.  This is in
contrast to what has been reported from Europe, and suggests clinical
differences from American Lyme disease.
------------------------------------------------------------------------------


Eye findings in Lyme disease
Robert Lesser, MD


Eye findings in Lyme disease have been reported to include conjunctivitis,
keratitis, uveitis and neuroretinitis.  Neuro-ophthalmologic findings
include papilledema, cranial nerve palsy, pupillary abnormalities and optic
neuropathy.
------------------------------------------------------------------------------


Dermatologic manifestations of Borreliosis
Rudolph J. Scrimenti, MD


Authors comment: Annular (round) lesions although described the most are
not really the most common.


*Important tip*: To help make diagnosis of EM use a strong light and a hair
dryer -- the heat helps bring out the EM which rapidly fades.


EM lesion on face or hands in adults are not well defined - making it
difficult to make the diagnosis - EM is seldom on palms or soles but when
they are the are fleeting.



V. ***** JARGON INDEX *****

Bb - Borrelia burgdorferi - The scientific name for the LD bacterium.
CDC - Centers for Disease Control - Federal agency in charge of tracking
     diseases and programs to prevent them.
CNS - Central Nervous System.
ELISA - Enzyme-linked Immunosorbent Assays - Common antibody test
EM - Erythema Migrans - The name of the "bull's eye" rash that appears in
    ~60% of the patients early in the infection.
IFA - Indirect Fluorescent Antibody - Common antibody test.
LD - Common abbreviation for Lyme Disease.
NIH - National Institutes of Health - Federal agency that conducts medical
     research and issues grants to research interests.
PCR - Polymerase Chain Reaction - A new test that detects the DNA sequence
     of the microbe in question.  Currently being tested for use in
     detecting LD, TB, and AIDS.
Spirochete - The LD bacterium.  It's given this name due to it's spiral
     shape.
Western Blot - A more precise antibody test.



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