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Volume: 2
Issue: 04
Date: 21-Mar-94

Table of Contents:

I.    ANALYSIS: Dr. Lloyd Miller on the PCR Study by Nocton et al
II.   ANNOUNCEMENT: LDF Medical Advisor Seeks Patient Input
III.  NIH RFA: Intravenous Antibiotics for Rheumatoid Arthritis
IV.   Q&A: Roxithromycin and Lyme (A)
V.    Q&A: Neuroreport article on Alzheimer's and LD (Q)
VI.   Q&A: Roxithromycin and Lyme (A)
VII.  Q&A: Pulse Therapy (Q)
VIII. Q&A: Alternative Treatments? (Q)
IX.   How to Subscribe, Contribute, and Get Back Issues


*                  The National Lyme Disease Network                  *
*                         LymeNet Newsletter                          *

IDX#                Volume 2 - Number 04 - 3/21/94
IDX#                            INDEX
IDX#  I.    ANALYSIS: Dr. Lloyd Miller on the PCR Study by Nocton et al
IDX#  II.   ANNOUNCEMENT: LDF Medical Advisor Seeks Patient Input
IDX#  III.  NIH RFA: Intravenous Antibiotics for Rheumatoid Arthritis
IDX#  IV.   Q&A: Roxithromycin and Lyme (A)
IDX#  V.    Q&A: Neuroreport article on Alzheimer's and LD (Q)
IDX#  VI.   Q&A: Roxithromycin and Lyme (A)
IDX#  VII.  Q&A: Pulse Therapy (Q)
IDX#  VIII. Q&A: Alternative Treatments? (Q)
IDX#  IX.   How to Subscribe, Contribute, and Get Back Issues


    "The main concern at this time is to see why there is
     a group of individuals who are going after the doctors
     who aggressively treat Lyme disease.  Why is there a
     strong influence to investigate the doctors and suspend
     their licenses?  Finally, why has there been an effort to
     publish incomplete or misleading patient data to illustrate
     that Lyme has been over-diagnosed and over-treated?"

  -- Dr. Craig Cleveland (see section II)


From the first issue, LymeNet Newsletter has always given editorial
priority to reader contributions.  This week, that policy is put to
the test as we publish the longest issue of the Newsletter ever.  
Despite the high volume of information, I hope each reader will take
the time to examine each article and respond when appropriate.

Many who read the recent Nocton retrospective study on PCR analysis
were puzzled by the conclusions announced by the researchers.  Some
felt the conclusions did not match the data, and the mass media were
fed misinformation.  In this issue, Dr. Lloyd Miller provides us with
his perspective on the study.

Next, Dr. Craig Cleveland asks patients to send him information
regarding their treatments and experiences.  He is seeking to compile
this information for analysis by a panel of physicians at the Lyme
Disease Foundation Conference next month.

Subsequently, we learn the NIH is interested in the effects of IV
antibiotics on RA patients.  We have heard many rumors about this
impending Request for Applications in the past few months, so we felt
it necessary to publish the information as soon as possible.

The remaining features are Questions and Answers.  Once again, your
contributions are important.  Send them via e-mail to
[email protected]  or by FAX to 908-789-0028.



I.    ANALYSIS: Dr. Lloyd Miller on the PCR Study by Nocton et al.
Sender: Lloyd E. Miller, DVM <[email protected]>

Nocton JJ, Dressler F, Rutledge BJ, Rys PN, Persing DH, Steere AC:
Detection of Borrelia burgdorferi DNA By Polymerase Chain Reaction In
Synovial Fluid From Patients With Lyme Arthritis. N Engl J Med

This article points out how important a research tool PCR testing can
be in investigating Lyme disease.  At the same time it shows that
negative PCR tests can not be used to completely rule out a diagnosis
of Lyme arthritis.  In their PCR testing it took four primer-probe
sets to detect Bb DNA in 75 (85%) of 88 patients.  Based on the
authors' assumptions, there should have been no false positive test
results since all patients (by their criteria) had Lyme arthritis.
The authors show that great care was taken to avoid contamination of
samples and false positives test results.  Interestingly, 13 (15%) of
the tests were then falsely negative in that they didn't detect Bb
DNA by any of the primer-probe sets.  Had the authors not used four
primer-probe sets the most they would have detected using the best
results of set 3 was 75% (25% false negative results).

Using the worst results of primer-probe set 4 (not detecting OspA DNA)
there would have been 52% false negative results.  Primer-probe sets 2
and 3 looked for the same OspA gene segments using different probes.
Results show that probes used also influence test outcomes. There were
11 more positive tests with set 3 than set 2.  Put another way, set 2
resulted in 11 more false negative results than set 3.  Apparently
certain substances in synovial fluid can inhibit the PCR and when
present in synovial fluid can result in false negative tests.  In 2 of
the 15 negative samples PCR inhibitors were detected.  What substance
inhibited these samples is not speculated.  Their data also demonstrate
interlaboratory variability.  Results between two laboratories using
the same primer-probe sets had 22% of their results discordant.

It appears that the PCR test is well suited for investigational
studies of Lyme disease if one takes into account all the possible
variables.  False positive tests are certainly possible in laboratories
not paying attention to strict laboratory procedure.  It is obvious
from the data presented that the false negative rate even under the
best of conditions can be high (15%).  It is also clear that the choice
of primer sets and probes is important in development of accurate PCR
tests.  One of the drawbacks I see with the PCR test is that Bb DNA
can not be found in the same tissue or fluid in every patient.
Unless the Bb containing fluid or tissue is tested the diagnosis will
be missed if only the PCR test is relied upon.

Soon after this article was published the public press reported that
the test used in this study was the new test we have been looking for
to diagnose Lyme disease.  In order for this test to become important
in the widespread commercial diagnosis of Lyme disease it would appear
that multiple primer-probe sets will need to be used in laboratories
using meticulous laboratory technique.  In the research laboratory
this would seem to be possible but is it in the busy commercial
laboratory setting?

The authors offer several possible reasons for the presence of Bb OspA
DNA in synovial fluid and then make the following statement:
       "Thus, it seems likely that the detection of OspA
        DNA in joint fluid indicates the presence of viable

If the above statement proves to be correct then the information
presented demonstrates persistence of Bb in both untreated and treated
patients.  Serial samples from 12 untreated patients taken from months
to years following initial diagnosis during episodes of arthritis were
positive for Bb DNA.  It would be interesting to know if during the
quiescent periods Bb DNA could have been detected.  Twelve patients
sampled 2 to 4 months after short course antibiotic treatment were all
(100%) positive.  Of 19 patients tested following longer courses of
antibiotic treatment 7 (37%) were still positive 1 day to 17 months
following treatment.  Of twelve patients treated even longer all were
negative (100%) 1 day to 4 years following treatment.  Of 10 patients
with chronic arthritis despite multiple courses of antibiotic 7 had
consistently negative tests but 3 (30%) were positive.  It is unclear
if any of the patients in this group are included in the 12 patients of
the longer treatment group that were negative following treatment.

The group of 19 were treated for median course lengths of 37 (20-56)
days orally or 14 (14-21) days IV.  The group of 12 treated even longer
were treated for median lengths of 48 (21-120) days orally or 30 (7-44)
days IV.  The authors state that statistically there is no difference
between the two groups based on the length of treatment; however there
certainly seems to be a clinical difference.  Based on these numbers
it would appear that initial treatment with longer uninterrupted courses
of antibiotic would be preferred.  The authors state that PCR was
usually negative after antibiotic treatment but their data do not show
this.  Of 43 patients tested following treatment 19 (44%) tested
positive following treatment.  This seems like an unacceptably high
percent to me.

Negative tests, especially in symptomatic patients, could mean that
there was not enough DNA to detect or that Bb are in the synovial
tissue and not the fluid or that they are true negative results and
the symptoms are due, as the authors state, to another mechanism.
We must be cautious about drawing conclusions about Lyme disease based
on the data presented.  The authors were working with a very small
population of patients.  They are using retrospective data and
information developed over 17 years.  They are investigating only one
aspect of Lyme -- arthritis.

This study makes some important contributions to the knowledge base of
Lyme disease.  There is a need for prospective studies of this nature
to be done for patients exhibiting all the diverse manifestations of
Lyme disease in which various body fluids and tissues are sampled.
And yet, without a "gold standard test" interpretation of the study
results remain somewhat uncertain.


II.   ANNOUNCEMENT: LDF Medical Advisor Seeks Patient Input
Sender: Craig Cleveland, M.D. <[email protected]>

I am working with a group of physicians to gather information about the
experiences of Lyme disease patients.

First, we are looking for information regarding insurance companies and
their treatment of the patients with Lyme Disease.  We are looking for
patients who had been diagnosed with Lyme, and had their therapy paid
for by the insurance companies, and for those who had their therapy cut
off by the insurance companies.  We need specific names of the
patients, their addresses (mail or e-mail), the insurance company, the
doctor's name, and any brief note concerning their treatment.

Second, we are looking specifically for patients thought to have Lyme,
but whose diagnosis was denied by a university or medical center, or
who were declared "cured" due to their 3-4 week course of meds.  Any
patients treated by short term treating physicians (i.e. Dr. Allen
Steere and his colleagues) would be great to contact.

I would like to mention one thing of great importance concerning the
request about the insurance companies.  There is a great deal of
pressure coming down on the doctors treating Lyme for more than 4
weeks.  There are threats to their licenses and one doctor has had his
license to practice pulled for treating Lyme.  Unless there is a
monumental effort by the Lyme community (i.e. patients and families),
doctors will possibly be pulling out of the treatment arena.
As practicing physicians, we cannot risk our licenses over a small
group of patients, no matter how great their need is.  If the ability
to practice medicine is taken away, we have all lost.  The patients
and their families must come forward and help to protect the right of
doctors to treat this disease.

The main concern at this time is to see why there is a group of
individuals who are going after the doctors who aggressively treat Lyme
disease.  Why is there a strong influence to investigate the doctors
and suspend their licenses?  Finally, why has there been an effort to
publish incomplete or misleading patient data to illustrate that Lyme
has been over-diagnosed and over-treated?

I will be the only one to have access to all the information.  I will
compile the information without using the patient's names, but if
necessary, the patients will be contacted prior to any use of the
information they have submitted.  We are very sensitive to the need to
isolate the patients and to protect the good physicians and the good
insurance companies.

I am hoping to have this information well before the 1994 Lyme Disease
Conference on April 22-23.  The Lyme Disease Foundation and the
supporting/advising doctors will be getting together during that time to
determine the approaches we need to make.  I can assure you that the
doctors involved are the ones who have been helping the patients the

The responses can be sent to me
via Compuserve
or via the Internet
   [email protected]
or to the office address.
   Dr. Craig Cleveland
   3330 Erie Ave.
   Cincinnati, OH 45208

Craig Cleveland, M.D., is one of the medical advisors to the Lyme
Disease Foundation.


III.  NIH RFA: Intravenous Antibiotics for Rheumatoid Arthritis
Source: NIH gopher server <>

94.02.25 RFP-RFA
NIH GUIDE, Volume 23, Number 8, February 25, 1994
RFA AVAILABLE:  AR-94-006   P.T. 34

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  April 15, 1994
Application Receipt Date:  July 13, 1994



The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) requests applications to initiate a pilot clinical
study designed to test the hypothesis that intravenous antibiotic
therapy is an effective and safe treatment for rheumatoid arthritis.
The budget appropriation report language for the National Institute
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) indicated
that funds were provided to "...initiate a pilot clinical trial to
study the efficacy of intravenous antibiotic therapy in treating
rheumatoid arthritis.  This study should include measures of disease
activity and, pending the outcome, be considered the initial step in
developing a multicenter clinical trial."


Applications may be submitted by domestic and foreign for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Applications from minority individuals and women are encouraged.


A sum of $500,000 (total cost) is available for this RFA.  One award
is anticipated. Of this amount, $50,000 is reserved for the operation
of a Data and Safety Monitoring Committee.



The role of infectious agents in the pathogenesis of rheumatoid
arthritis is uncertain.  In 1971 a small clinical trial of low dose
tetracycline treatment for rheumatoid arthritis demonstrated no
beneficial effect (Skinner et al., Arthritis Rheum 1971;14:727-35).
In two small open trials oral minocycline appeared to improve outcome
in rheumatoid patients (Breedveld et al., J Rheumatol 1990;17:43-6;
Langevitz et al., J Rheumatol 1992;19:1502-4).  In April 1991, the
NIAMS initiated a double-blind, placebo-controlled clinical trial of
oral minocycline.  The results of this trial, as well as the results
of a similar trial in the Netherlands, were presented at the 57th
Annual Meeting of the American College of Rheumatology in San
Antonio, Texas, on November 8, 1993 (Tilley et al., Arthritis Rheum
1993;36:s46 and Kloppenburg et al., Arthritis Rheum 1993;36:s47).
The American study showed modest benefit and low toxicity, while the
European study showed little benefit and moderate toxicity.

For many years the Senate Appropriations Committee has expressed an
interest in the infectious theory of rheumatoid arthritis, especially
the possibility that mycoplasma organisms cause rheumatoid arthritis.
In its 1994 Appropriations Report, the Committee directed "that
NIAMS, within the funds provided, initiate a pilot clinical trial to
study the efficacy of intravenous antibiotic therapy in treating
rheumatoid arthritis.  The study should include measures of disease
activity... "  The NIAMS now solicits applications to fulfill this

Goals and Scope

The goal of this RFA, accordingly, is to encourage development of a
pilot clinical research project designed to test the hypothesis that
intravenous antibiotic therapy is a potentially effective and safe
therapy for RA.


Prospective applicants are asked to submit, by June 1, 1994, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of subsequent applications, the information that it contains allows
NIAMS staff to estimate the potential review workload and to avoid
conflict of interest in the review.  The letter of intent is to be
sent to Dr. Susana A.S. Sztein at the address listed under INQUIRIES.


Written and telephone requests for the RFA are encouraged.  The
opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct requests for the RFA, inquiries regarding programmatic issues
and requests for guidelines for the DSMC to:

Dr. Susana A.S. Sztein
Rheumatic Diseases Branch,
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD  20892
Telephone:  (301) 594-9953
FAX:  (301) 594-9673

Direct inquiries regarding fiscal matters to:

Mrs. Diane M. Watson
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 732A
Bethesda, MD  20892
Telephone:  (301) 594-9965
FAX:  (301) 594-9950


This program is described in the Catalog of Federal Domestic
Assistance No. 93.846, Arthritis and Musculoskeletal and Skin
Diseases Research.  Awards are made under authorization of the Public
Health Service Act, Title IV, Part A (Public Law 78-410, as amended
by Public Law 99-158, 42 USC 241 and 285) and administered under PHS
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency


IV.   Q&A: Roxithromycin and Lyme (A)
Sender: Jerry Grandoni <[email protected]>

I would like to comment on Dr. Miller's question concerning selection
of antibiotic resistant variants of Borrelia by antibiotic treatment.
Many antibiotic resistance genes are carried on plasmids that are not
required for survival of the cell unless there is selection for them.
The selection comes from the antibiotic treatment.  When the treatment
is halted the plasmid becomes an energetic load on the bacterial cell
and is often discarded.  That is why it is important to rotate the use
of various antibiotics.  Treatment with roxithromycin may select for
spirochetes that contain a plasmid carrying a gene that confers
resistance to the drug.  Furthermore, if the plasmid is a conjugative
type it can be transferred directly from cell to cell so resistance can
spread quickly.  One of the major problems that clinics are facing now
is the emergence of strains containing multi-resistant plasmids.  This
is important because the genes for resistance to several antibiotics
can be carried on one plasmid.  Selection for one of these genes

causes the retention of all the resistance genes.  Formation of such
multi-resistant plasmids may take years of selective pressure and
B. burgdorferi may not have developed them yet.

Jerry Grandoni
Univ. of Med. and Dent. of NJ
School of Osteopathic Med.
Stratford, NJ  08084


V.    Q&A: Neuroreport article on Alzheimer's and LD (Q)
Sender: Jerry Grandoni <[email protected]>

In one of the back issues of the lymenet newsletter there was an
article about a paper that reported a possible connection between
Alzheimer's disease and the presence of spirochetes in the blood.
The paper is from the journal Neuroreport, July, 1993.  Has there been
any confirmation of these findings or even further studies done to
test them?

Jerry Grandoni
Univ. of Med. and Dent. of NJ
School of Osteopathic Med.
Stratford, NJ  08084

-Ed.  No follow-up reports, confirmations or analyses have come to the
attention of the editors.  Various computer searches have also failed
to yield any results.  If anyone is aware of any such publications,
please let us know.  We will report any new information as soon it
becomes available.


VI.   Q&A: Roxithromycin and Lyme (A)
Sender: SUZANNE COLTER <[email protected]>

I began doing some reading and researching into the use of
Roxithromycin in the treatment of Lyme Disease a few years ago when I
had been diagnosed and was to begin treatment for late-stage Lyme.

According to the book, "LYME DISEASE: Patient/Physician Perspectives",
Roxithromycin has shown promise in treating later stage Lyme,
especially after "traditional" antibiotic regimens have failed.  It
has also been investigated for treating Toxoplasmosis (a protozoan
infection of the brain often associated with AIDS).  This looks
promising for Lyme patients experiencing chronic infection of brain

However, Roxithromycin has proven ineffective "after" cerebral
abscesses or lesions have formed.  Consequently, Lyme patients who
have white matter lesions revealed on an MRI may not benefit from its
use.  Possibly, its failure is because this drug is unable to
adequately penetrate the lesions where the Lyme "spirochetes" can hide
out.  There are newer generation antibiotics available that better
penetrate the blood brain barrier.  One or a combination of these may
be a better choice, in this case.

Roxithromycin has been used in combinations as well for treating Lyme
Disease.  One of such combinations include the use with Bactrim,
showing good results.  However, Bactrim is not tolerated by some.
In this case, other drugs such as Dapsone (also a sulfur drug) have
been used.

In my personal search for Roxithromycin, I found it was not available
in the USA but that it was being used in other countries including
England, Germany, France, and Spain.  I contacted a good friend that
resides in Mannheim, Germany and she discussed this with her physician
there.  Her physician was willing to work with mine in making it
available for my use.

At that time, a 3 month supply of Roxithromycin, or "Rulid", could be
ordered and made available to physicians in the USA.  Persons visiting
in Europe could also bring back a 3 month supply if they had a valid
prescription from a doctor that would be monitoring its use.  During
its use, Liver enzyme levels should be checked on a regular basis,
especially upon commencing treatment.  The FDA has approved this type
of importation under the category of "compassionate uses" for people
with serious or life-threatening illnesses.

My physician was reluctant to pursue this endeavor due to unknown
obstacles that might occur, such as delays in receiving the drug on a
timely basis, its continued availability, etc.  He would rather wait
until the FDA approves its use in the USA (who knows how long that might

Note: (Some food for thought)  This physician from Germany questioned
as to why I specifically wanted Roxithromycin (Rulid) for the treatment
of Lyme Disease.  He stated that there were other, better drugs being
used for the treatment of this tick related spirochetal infection
(they do not refer to it as "Lyme Disease" in Germany - that is just
the given name for it here in the US) that offered much better cure
success rates.  Unfortunately, despite several attempts to learn what
these better drugs he referred to are, I have had no luck in getting
a reply!  But I later received a 1-month supply of "Rulid" that this
physician prescribed and had my friend send to me, just in case I
wanted to try it.  I never began taking it due to the fact my
physician was hesitant to get me started on it for the reasons
stated above.

In the meantime, I received IV Rocephin, sometimes accompanied with IV
Doxycycline, for several months throughout 1992.  Since then, we have
found I do well on the combination oral antibiotic regimen of Biaxin,
Vantin and Rimactane.  That is - as long as I stay on it.  Attempts to
decrease, or "wean me down", causes my Lyme symptoms to flare up.

My physician, having both a degree in Pharmacology and Internal Medicine,
is very knowledgeable in the use of combination antibiotic treatments for
his Lyme patients here in northern Missouri.  His reasoning for the use
of the drug, Rimactane, (which is usually restricted to the treatment of
TB) is that in using it allows better penetration, especially with the
blood brain barrier, of the other two antibiotics.

He has helped many of us to improve and relentlessly works in keeping our
conditions "stable".  We are VERY lucky to have him.

I want to wish you the best in your endeavors with the National LymeNet.
I commend you on all your efforts in getting it started.  It was a
wonderful idea and will benefit many.  I am looking forward to being a
part of it.

Many thanks,
Suzanne Colter, President


VII.  Q&A: Pulse Therapy (Q)
Sender: Rolf K. Taylor <[email protected]>

Keep up the good work on the LymeNet Newsletter.

I am doing some research on "Pulse Therapy" and would like to enlist
the help of fellow readers.

1) Do any readers know of physicians who are actively using "Pulse
Therapy" for Lyme Disease (See Definition below).  If so please send
the name, address and phone number of this physician so I can
contact her/him.

2) Have any readers under gone "Pulse Therapy" under the advice of
a physician?  If so please send me your name and address and phone
number so I can contact you.

3) Do any readers know of published research on "Pulse Therapy"?
My only references so far are a letter in The Lancet (By D. Hassler)
07-20-91, An article in Lyme Disease Update Nov 1991 and one other
reference from the LymeNet Newsletter about 4 issue back.

"Pulse Therapy is the deliberate interruption of antibiotic treatment
for a few days to week and then resuming treatment on a regular
schedule.  The theory is that the bacteria may not try to divide while
treatment is in progress, but that it may due so when the treatment
has stopped, and thus be more vulnerable when the therapy re-starts.

This information is needed for an article I am writing and will appear
in one of the Lyme Publications.  People who have assisted me in
collecting this information will receive a copy of the article by e-mail
along with an complete bibliography on Pulse Therapy.

Please respond by 1) E-mail, 2) Fax 216-397-0321, or 3) By US
Mail; R. K. Taylor; 14128 Superior Rd; East Cleveland, OH 44118-1103

Thank You for your assistance.


VIII. Q&A: Alternative Treatments? (Q)
Sender: Carol Gardner <[email protected]>

I have been taking antibiotics for Lyme Disease on and off for almost
a year.  The last round of IV eliminated the symptoms of Lyme, but I
started having painful digestive problems that seem to be a result of
an overgrowth of yeast.  I am now being treated for that problem, but
the Lyme symptoms are beginning to return.  My question concerns
nutrition.  Are there any particular vitamins, minerals, herbs, etc.
that help?  I'd like to get the yeast problem under control before
taking more antibiotics, but I don't want the Lyme symptoms to become
debilitating.  (My main problems are cognitive--confusion, memory loss,
trouble reading, disorientation, blurred vision, dangerous driving,
etc.)  Does anyone know of alternative treatments?
What are my options?


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