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Volume: 4
Issue: 11
Date: 05-Aug-96


Table of Contents:

I.    INFECTION: Physician Preferences in the Diagnosis and
      Treatment of Lyme Disease in the United States
II.   NIAID: NIAID Awards Contract for Post-Lyme Disease Syndrome
      Studies
III.  NIAID: Questions and Answers About NIAID's Chronic Lyme
      Disease Study
IV.   AP:  N.J. Gov. Has Lyme Symptoms
V.    About The LymeNet Newsletter


Newsletter:

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*                  The National Lyme Disease Network                  *
*                         LymeNet Newsletter                          *
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IDX#                Volume 4 - Number 11 - 8/05/96
IDX#                            INDEX
IDX#
IDX#  I.    INFECTION: Physician Preferences in the Diagnosis and
IDX#        Treatment of Lyme Disease in the United States
IDX#  II.   NIAID: NIAID Awards Contract for Post-Lyme Disease Syndrome
IDX#        Studies
IDX#  III.  NIAID: Questions and Answers About NIAID's Chronic Lyme
IDX#        Disease Study
IDX#  IV.   AP:  N.J. Gov. Has Lyme Symptoms
IDX#  V.    About The LymeNet Newsletter
IDX#



QUOTE OF THE WEEK:

       "Scientific thought is not an accompaniment or
        condition of human progress, but human progress
        itself."


        William Kingdon Clifford, 1945-1879


I.    INFECTION: Physician Preferences in the Diagnosis and Treatment
     of Lyme Disease in the United States
---------------------------------------------------------------------
AUTHORS:  M. H. Ziska, S. T. Donta, F. C. Demarest
REFERENCE: Infection 24 (1996) No. 2, 182-186
ABSTRACT:


To assess physician preferences in the diagnosis and treatment of Lyme
disease, questionnaires were sent to physicians in various Lyme
disease endemic areas in the U.S.  Seventy-eight responses were
analyzed.  Both ELISA and Western blot were ordered by 86% of
responders.  Fifty percent of responders believed that 25% or more of
patients who have Lyme disease were seronegative.  The treatment was
influenced by physician specialty.  Antibiotic treatment for tick
bite was prescribed by 20% of responders.  Erythema migrans rash was
treated by all responders without serologic confirmation.  The median
treatment duration of erythema migrans was 4 weeks.  For
post-erythema migrans Lyme disease, 43% of responders treat 3 months
or more; for chronic Lyme disease, 57% of responders treat 3 months
or more.  Our survey documents significant differences between
published recommendations and actual practices.  Physician education
and clinical trials are needed to clarify the reasons for these
differences.



=====*=====


II.   NIAID: NIAID Awards Contract for Post-Lyme Disease Syndrome
     Studies
-----------------------------------------------------------------
Sender: John Bowersox <Bowersox@nih.gov>
Office of Communications
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda,  MD
Friday, June 28, 1996                             (301) 402-1663


The National Institute of Allergy and Infectious Diseases (NIAID)
has awarded a five-year contract to the New England Medical Center
(NEMC) in Boston, Mass., to study the pathogenesis and treatment of
post-Lyme disease syndrome (PLDS).  Mark Klempner, M.D., is the
principal investigator of the $4.2 million study.


"This research will help us answer important questions regarding the
nature of Lyme disease sequelae and the most effective treatment for
individuals affected by this syndrome," says NIAID Director Anthony
S. Fauci, M.D.


Lyme disease is caused by infection with the tick-borne spirochete
Borrelia burgdorferi.  Since 1982, when the organism was first
identified by NIAID scientists, more than 50,000 cases of Lyme disease
have been reported in the United States.  Patients usually are treated
successfully in the early stages of the disease with a two- to four-
week course of oral antibiotics.  Additional treatment with
intravenous antibiotics may be required in some cases.  Several
months after patients with the initial symptoms of Lyme disease have
been treated, some of them develop PLDS, a condition also known as
chronic Lyme disease and characterized by persistent musculoskeletal
and peripheral nerve pain, fatigue and memory impairment.


"There is much uncertainty about the pathogenesis of PLDS.  We don't
know if it is caused by ongoing active infection with B. burgdorferi
or another tick-borne pathogen, or if PLDS symptoms result from
reinfection," says John R. La Montagne, Ph.D., director of NIAID's
Division of Microbiology and Infectious Diseases.  "Inflammatory or
autoimmune responses occurring during early infection, prior to
treatment with antibiotics, may also play a role in PLDS.  We also
have a lot to learn about its clinical manifestations.  This contract
will allow us to define this syndrome more precisely and develop
rational strategies for treating it."


As contractor, NEMC researchers will work closely with NIAID staff,
and collaborate with scientists at New York Medical College, the
University of Minnesota School of Medicine, and Tufts University
School of Medicine.  Studies on the cause or causes of PLDS and the
evaluation of potential therapies for patients with PLDS are planned.
Treatment success will be measured with a variety of tests that
assess symptoms, signs and laboratory manifestations of PLDS.


This contract award to NEMC follows a rigorous objective review
process, during which all proposals received under an NIAID
solicitation were evaluated and scored by non-government Lyme
disease experts.  The new study further expands NIAID's growing
portfolio of Lyme disease research projects.  NIAID currently supports
a variety of  investigator-initiated studies of the pathogenesis,
diagnosis and treatment of Lyme disease.  In addition, intramural
scientists from NIAID and other institutes at the National Institutes
of Health (NIH) are collaborating on Lyme disease studies.


According to NIAID's Phillip Baker, Ph.D., the project officer for the
study, the NEMC researchers will work closely with NIH intramural
investigators.


"Although these new studies will not supply all the answers with
regard to the etiology and treatment of PLDS," says Dr. Baker,
"they should provide meaningful information that can help us move
toward the development of effective solutions to this problem."



=====*=====


III.  NIAID: Questions and Answers About NIAID's Chronic Lyme Disease
     Study
---------------------------------------------------------------------
Sender: Judy Murphy <JMURPHY@flash.niaid.nih.gov>
Office of Communications
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892
June 1996
   
The National Institute of Allergy and Infectious Diseases (NIAID)
recently announced the award of a five-year contract to the New
England Medical Center (NEMC) to study the pathogenesis and treatment
of post-Lyme disease syndrome (PLDS).  Many people have called NIAID
to ask questions about this contract and to voice their opinions.  
The question-and-answer document below is designed to respond to these
concerns to the extent possible at this time.  


It is important to keep in mind that this is a research study,
designed to help scientists better understand Lyme disease and to
develop better ways of treating this disease.  The research carried
out under NIAID's direction as a part of this contract will increase
our knowledge of this disease and provide the foundation for new and
potentially more effective approaches to be explored in future
studies.  The ultimate goal will be to improve the diagnosis and
treatment of people with PLDS.



Q. Why is NIAID funding this study?

A. Although scientists have identified Borrelia burgdorferi as the
  bacterium that causes Lyme disease, we need to know much more about
  the pathology associated with this disease.  Scientists have many
  questions about the chronic manifestations of Lyme disease.  The
  issue is not whether such a syndrome exists; rather, it is how B.
  burgdorferi is able to elicit such a broad range of long-term
  problems in some people.  


  We don't know whether the symptoms associated with PLDS are caused
  by one or more of the following: an ongoing (persistent) infection
  with B. burgdorferi or another tick-borne pathogen; reinfection
  with B. burgdorferi; an autoimmune or inflammatory response
  associated with the initial infection; or some other yet-to-be-
  defined mechanism.  For this reason, NIAID is using the term
  PLDS, rather than chronic Lyme disease.  The latter implies that
  the symptoms observed are the result of persistent infection by
  B. burgdorferi.  Although that indeed may be the case, in most
  instances direct evidence of persistent infection is lacking.


  We also need to document what constitutes PLDS because the clinical
  characteristics of this syndrome have not been described precisely.  
  In addition, physicians are uncertain about which treatment
  strategies would be most effective.  For example:
    * What types of antibiotics should be used?  
    * How long should they be taken?  
    * If beneficial effects occur, how long do they last?
    * Should drugs other than antibiotics be tested?
    * What outcomes can be used to determine that a given course of
      antibiotic treatment is indeed effective?  


  Research under this contract will examine many of these questions
  in a step-wise and systematic manner.  This will involve conducting
  preliminary studies to more fully characterize PLDS.  The study
  will determine the therapeutic approaches, outcomes and monitoring
  techniques likely to give the most useful information and help
  doctors who are treating people with PLDS.



Q. Who are the investigators working on this contract?

A. Dr. Mark Klempner of the New England Medical Center is the
  principal investigator.  Together with the NIAID project officer,
  Dr. Klempner is responsible for the overall design and conduct of
  the studies performed under the contract.  Dr. Arthur Weinstein will
  coordinate all aspects of the study at Westchester County Medical
  Center/New York Medical College.  Dr. Gary Wormser, also at New
  York Medical College, will oversee the administration of study
  medications.  In this role, he will work closely with the nursing
  staff to minimize any adverse reactions to antibiotics, as well as
  bacterial infections sometimes associated with prolonged
  intravenous therapy.  He also will be responsible for the culture of
  spinal fluid samples to detect the presence of viable B.
  burgdorferi.  Dr. Jesse Goodman, University of Minnesota School of
  Medicine, will conduct all laboratory tests for the detection of
  possible co-infecting agents (ehrlichia and babesia).  Dr. Allen
  Steere of Tufts University will oversee blinded serologic assays on

  patient blood samples.  All of these investigators are experts in
  their fields.  Because the studies will be blinded (see below), any
  possible bias of investigators will be avoided.



Q. How were the contract proposals reviewed and evaluated?

A. A panel of scientists reviews and evaluates contract proposals,
  ranking them according to scientific merit, which is one of the
  chief factors considered in a contract award.  Other factors
  include the projected cost of carrying out the work required by
  the contract.  The contract proposal provides evidence that the
  investigators can meet the scientific objectives established by
  the Institute for carrying out the type of studies to be done
  under the contract.
 
  Thus, the proposal provides a means for the review panel to evaluate
  both the scientific expertise and the soundness of the experimental
  design devised by the offerors.  Although the sample protocol may
  contain elements that are eventually adopted into the final
  protocol, its primary purpose is to provide a means for the
  scientific reviewers to assess the capability and approach of the
  offerors.  In contrast to staff involvement with investigators
  given a research grant, the Institute staff work with investigators

  under contract at every step to refine the design of the treatment
  protocol to ensure that the studies to be performed will achieve
  NIAID's ultimate objectives.



Q. Will clinical trials be part of this contract?

A. Yes.  Phase III clinical studies are a major component.  These will
  be multicentered studies conducted in collaboration with scientists
  in the intramural research program of the NIAID and elsewhere.  
  The goal of the studies is to further characterize PLDS so that
  rational and more effective therapeutic approaches can be devised
  for use in larger populations of patients.


  These studies will be double-blind and placebo-controlled.  This
  means that all specimens to be tested will be coded so that
  neither the investigators nor the patients will know who is getting
  antibiotic and who is receiving placebo.  Only after the study has
  been completed and all specimens have been analyzed will the codes
  be broken so that the effectiveness of treatment can be evaluated.  
  Such an approach is designed to ensure objectivity and rule out
  any possible influence of bias or preconceived ideas about any
  aspect of the studies.


  Protocol details still being worked out include:
    * the antibiotics to be tested -- which ones, in what sequence and
      for how long;
    * numbers of patients, which will be determined by the protocol
      design and biostatistical considerations.



Q. Who will oversee the work done under this contract?

A. The NIAID Project Officer will have final approval of all studies
  that will be undertaken.  As with all Phase III clinical studies,
  an independent Data and Safety Monitoring Board (DSMB) -- appointed
  by the National Institutes of Health (NIH) -- will regularly
  evaluate the results obtained.  In addition, NIAID is establishing
  an advisory body made up of research scientists, medical experts
  and members of Lyme disease patient advocacy groups to assist in
  defining the issues to be addressed and in resolving any problems
  that may arise during the course of these studies.



Q. How will studies conducted under this contract relate to the NIH
  intramural clinical trial?


A. NEMC researchers will work closely with NIH intramural
  investigators, although the patient populations selected for each
  study will differ.  In the contract studies, patients will have had
  a documented case of acute Lyme disease, will have received
  treatment and recovered, but they will subsequently have developed
  all of the signs and symptoms associated with PLDS.  By contrast,
  patients to be enrolled in the intramural studies will have a
  higher probability of being actively infected based on the results
  of a variety of laboratory tests.  Although the contract studies
  will have a placebo arm, all patients enrolled in the intramural
  studies who fill certain criteria specified in the protocol will
  receive antibiotic.


  Investigators in both studies will collaborate to determine whether
  the immunologic and diagnostic assays used to monitor the
  effectiveness of antibiotic therapy prove useful for both groups of
  patients.  New assays not currently available to physicians will be
  used, and NIAID staff hope that these tests will provide valuable
  insights into PLDS and will prove useful in evaluating the
  effectiveness of antibiotic treatment.



Q. The intramural studies require a positive antibody test and Western
  blot.  Will the contract studies also require such tests, even
  though some people with symptoms of PLDS are seronegative?


A. These antibody tests are used in the initial diagnosis of acute
  Lyme disease.  Although the patients in the intramural studies must
  have positive ELISA and Western blot tests, the contract study
  patients may or may not be antibody positive if they have been
  treated in the past with antibiotics.  



Q. When will final details of any protocols be complete?

A. We plan to be enrolling and treating patients with PLDS by early
  fall.  The intramural study is already open to accrual.  As soon as
  information about the studies becomes available, NIAID will post it
  on our home page on the World Wide Web (www.niaid.nih.gov) and alert
  the newsletters on our mailing list.  NEMC will also publicize new
  developments.



=====*=====


IV.   AP:  N.J. Gov. Has Lyme Symptoms
--------------------------------------
DATE: July 23, 1996
DATELINE: TRENTON, N.J.


Gov. Christie Whitman has shown symptoms of a tick-borne blood
infection that could be Lyme disease, but she is feeling well and
maintaining her work schedule, her spokeswoman said Tuesday.


Whitman is on an antibiotic that is expected to clear up the
infection without further illness, spokeswoman Becky Taylor said.
She said the governor would probably have a blood test Tuesday in
hopes of getting a definite diagnosis.


Whitman, 49, canceled her public schedule last Wednesday because she
was not feeling well.  Her office at the time said she had flulike
symptoms.


The first-term Republican, a prominent moderate, has repeatedly said
she is not interested in the party's vice presidential nomination.
She had attributed fatigue and an aching elbow to her busy schedule
and recurrent tendinitis and did not seek medical treatment until last
week when she got a high fever and increasing body aches, the
Asbury Park Press reported Tuesday.


Whitman told the newspaper Monday that her doctor suspected she got
one of three illnesses spread by deer tick bites: Lyme disease,
Rocky Mountain spotted fever or HGE, a bacterial infection identified
last year.


The governor and her husband, John, have a farm in an area with a
relatively high incidence of Lyme disease.


She said she does not recall being bitten by a tick.  John Whitman
recently had the bull's-eye rash associated with Lyme disease,
although he did not show any other Lyme symptoms, the newspaper said.


Medical attention for Lyme disease is important, one expert said.

"It's important to make a diagnosis and get treatment.  The symptoms
that do not receive adequate treatment may recur," said Dr. David
Alcid, chief of infectious diseases at St. Peter's Medical Center,
New Brunswick.
             


=====*=====


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