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Volume: 7
Issue: 12
Date: 20-Dec-99

Table of Contents:

I.    LYMENET: SmithKline Sued Over Lyme Vaccine
II.   LYMENET: Scientific Highlights of the 1999 Bard College Lyme
III.  ARTHRITIS RHEUM: Association of antibiotic treatment-resistant
      Lyme arthritis with T cell responses to dominant epitopes of
      outer surface protein A of Borrelia burgdorferi.


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

                  Volume 7 / Number 12 / 20-DEC-1999

I.    LYMENET: SmithKline Sued Over Lyme Vaccine
II.   LYMENET: Scientific Highlights of the 1999 Bard College Lyme
III.  ARTHRITIS RHEUM: Association of antibiotic treatment-resistant
     Lyme arthritis with T cell responses to dominant epitopes of
     outer surface protein A of Borrelia burgdorferi.


I.    LYMENET: SmithKline Sued Over Lyme Vaccine
Date: December 14, 1999

A class action lawsuit filed in Pennsylvania claims the vaccine that
prevents Lyme Disease causes an incurable form of autoimmune
arthritis and, for some, could produce symptoms far worse than those
brought on by the illness.

The complaint, filed in Chester County Court of Common Pleas,
alleges SmithKline Beecham, manufacturers of the widely touted
LYMErix vaccine, failed to warn doctors and the general public that
nearly 30 percent of the population was pre-disposed to a degenerative
autoimmune syndrome, which the lawsuit says is triggered by contents
of the inoculation.

"Once this autoimmune reaction is triggered, it cannot be cured and
can only be treated symptomatically for the remainder of the vaccine
recipient's life," the complaint says.

According to the class action, SmithKline used high concentrations
of a surface protein called OspA as the foundation for its vaccine.
When bitten by a Lyme infected parasite, humans are not exposed to
OspA protein. The levels of OspA that enter the bloodstream
at any phase of the three-dose LYMErix vaccine, however, place
patients classified by genetic type HLA-DR4+ at risk of developing a
condition referred to as "treatment-resistant" Lyme Arthritis, the
lawsuit says.

Despite this "well documented relationship" between OspA and
treatment-resistant Lyme Arthritis, SmithKline neglected to include
the information in its widely disseminated promotional literature
and insisted LYMErix was safe and generally well tolerated, the
class action says.

About one-third of the general population is HLA-DR4+ and risks
contracting the arthritic condition when exposed to the vaccine,
according to the complaint. The HLA-DR4+ trait is easily detected
by a routine blood test; however, SmithKline never recommended
that doctors screen for the trait before administering the
vaccine, the lawsuit alleges.

The complaint further alleges that patients who are infected with
Lyme bacteria when they receive LYMErix -- whether asymptomatic or
in the early stages of infection -- could suffer symptoms more
progressive and enhanced than if they had not received the vaccine.

SmithKline, the class action says, also neglected to inform doctors
and the general public that periodic booster shots beyond the series
of three vaccinations would be necessary to maintain immunity to the

The class action includes counts of negligence, unfair trade
practices and a bid for medical monitoring of those who are placed
at risk of developing autoimmune arthritis but have not yet been
diagnosed with the condition.

The class action complaint was filed by Stephen A. Sheller and
Albert J. Brooks Jr. of Sheller, Ludwig & Badey in Philadelphia.

Sheller said that in the wake of filing the class action, he expects
to file claims on behalf of individuals who received the LYMErix
vaccine and are now suffering from the autoimmune arthritis. He is
seeking vaccine recipients (both symptomatic and asymptomatic),
particularly from New Jersey.  For more information, call


II.   LYMENET: Scientific Highlights of the 1999 Bard College Lyme
Sender: Nancy Berntsen, RN, BSN <[email protected]>
Date: November 22, 1999

This conference shed so much light on Lyme, too much for even the most
fastidious note-taker to record. Fortunately, videos and a
science-rich syllabus of the event will be available at a later date.
Below are some highlights of several of the panelists' presentations.

The keynote speaker was none other than Willy Burdorfer, Ph. D, a
brilliant, spry, blue eyed, white-haired man who identified the
bacteria that causes Lyme disease in the early 1980's. Using excellent
slides to depict the forms of spirochetes, he spoke on the history of
spirochetal illness and complexity of vector-borne spirochetes.

Dr. Charles Ray Jones strongly advocated prophylactic treatment of
tick bites for children and long term treatment basically two months
past cessation of all Lyme symptoms. He spoke favorably of culturing
for Lyme bacteria. He presented his recently released video, "The
Children of Lyme" that brought tears to the eyes of many viewers.

Michael C. Caldwell, MD, MPH, Commission of Health, Dutchess County
Health Department spoke about an increased awareness of Lyme disease
in his county where 80% of the ticks carry Lyme bacteria. He
attributes more reported cases of Lyme disease to this awareness and
showed several local newspapers with headlines regarding prevalence of
Lyme disease and ticks in Dutchess county. He and his community
participated in vaccine studies and was a "human guinea pig"
himself. He was favorable about the SmithKline vaccine thus far,
though he said more time is needed to evaluate it fully. He is very
interested in means of preventing tick-borne illnesses including
means of controlling ticks and hopes to add a full time
entomologist to the area in light of West Nile virus, which should
in turn help with tbi and tick research in general in his area.

Dr. Kenneth Liegner & his nurse practitioner, Janice Kochevar did a
study that strongly indicates other family members of those with Lyme
disease should be evaluated for possible infection. They also presented
a protocol for the nurse practitioner in accessing for Lyme disease.

Ms. Kochevar along with M. Lynne Canon and Sandra Berenbaum
specifically discussed adolescents and neuropsychiatric Lyme disease.

There was a general concern over lack of standardization amongst the
labs. Much time was spent explaining ELISA and Western Blot testing and
shortcomings too. Dr. L. advises sending bloodwork to 2 or 3 reputable
labs as results can vary just from slight temperature changes.

Regarding babesiosis & ehrlichiosis, more than one speaker indicated
that these are under-reported and there is concern that they may end up
underestimated as Lyme disease is as they are not tested enough. Also,
the "southern" type babesiosis is not limited to the south, and
babesiosis is spreading by birds to non-coastal areas.

There is some suggestion that as alarm over the West Nile virus
increases, ticks will be under more surveillance so this could help in
prevention of Lyme disease. There was some discussion about reducing the
number of ticks, too.

One doctor said we don't know enough about the tick itself, and that
the tick may very well carry a lot of other viruses and infections that
are currently unidentified. Several doctors pointed out how harmful
the three major tick-borne illnesses are in regard to causing
immuno-deficiency and that this was cause for concern over persistent
infection, allergies and auto-immunity.

Dr. David Dorward, a co-worker of Dr. Burdorfer of Rocky Mountain
Laboratories, spoke on the pathology of Lyme diseases. He continued
with projections of excellent visual slides of spirochetes, including
an actual microscopic movie of living spirochetes in vitro. He displayed
a spirochete with a whitish stain entering a dead lymphocyte and exiting
coated with the bright stain of the lymphocyte, inferring it was
sheathed and disguised as a lymphocyte. In addition, he had two 3D
slides of spirochetes that brought these microbes right in your face!
It was truly incredible.

Paul Duray, M.D. of National Institutes of Health, department of
pathology early on stated that, regarding Lyme disease, "absence of
evidence is not evidence of absence." He spoke very favorably of
obtaining biopsies which often show unusual clusters of T & B cells
characteristic of Lyme infection. The cost of such is quite reasonable.
He disclosed the vast number of body organs and parts that Borrelia
burdorferi (Bb) infects. He pointed out that Lyme disease is an
inflammatory disease, so we should expect to see inflammation.

Nick Harris, Ph. D., president and CEO of IgeneX presented the
controversy of diagnosis using a two step protocol. He provided an
excellent discussion of the lab tests for Lyme disease, how they work
and their shortcomings. He also discussed the difficulty of culturing
from biopsy though he conceded it's value. His presentation was
followed by another representative of IgeneX, Jyotsna Shah, Ph. D.,
director of research and development. The discussion concluded with
information about the PCR (polymer chain reaction) test and FISH
(fluorescent in-situ hybridization) test.

Carmine Sorbera, director of cardiac electrophysiology. His discussion
involved heart problems caused by Lyme disease including myocarditis
and autonomic dysfunction, explaining the mechanism of "POTS" which
causes a type of shock and lowering of the blood pressure noted by both
tachycardia and bradycardia. He discussed use of a tilt table to
evaluate for this condition and variations that can affect the results
of a tilt test.

Brian Fallon, M.D. presented a most interesting presentation of the
psychiatric manifestations of Lyme disease in children and adults.
Through the years, he's fine-tuned the art and skill of deciphering
intertwined diagnoses of somatic and hypochondriac illnesses with
affects caused by Lyme disease. For instance, panic attacks that last
only a few minutes are not like those of Lyme disease which can last
one to three hours. People with non-Lyme anxiety do not have memory
problems. He provided a printout on psychoneurological aspects of Lyme
disease in adolescents, noting that ADD, autistic behaviors, PMS,
oppositional defiance behavior and numerous other symptoms can be
caused or worsened by Lyme disease.

Dr. Marylynn Botsford Barkley, section of Neurology, Physiology &
Behavior, Univ. of CA at Davis, Davis, CA. presented some very
interesting correlations. Of particular interest to females was a
discussion of two studies regarding the menstrual cycle & Lyme disease.
One doctor did extensive documentation of her cycle in relation to
night sweats & severity of such. They peaked around the first day of
her menses for many, many months and only diminished with antibiotic
use. This suggested that there is a "immune reaction" phase of the
menstrual cycle that corresponds with dropping progesterone levels.
The other study regarded a noteworthy increase in Lyme symptoms peaking
at the onset of menses.

Louis Magnarelli, Ph. D.. of the Department of Entomology, Connecticut
Agricultural Experiment Station discussed reported cases of the three
most prevalent tick borne illnesses in Connecticut, stating figures
were likely only 20% of the actual cases. He mentioned chipmunks as
perhaps more responsible in spreading tbi than mice. He also referred
to horses and dogs as carriers. He dispelled a common misconception
that HGE and HME are regionalized. He stressed that edges of woods
are where risk of tick exposure is greatest in yards. He could not
comment whether West Nile Virus can be carried by ticks in the U.S.
but that it is in Europe.

Richard I. Horowitz, M.D. emphasized that Lyme disease, babesiosis and
ehrlichiosis are all immunosuppressive diseases. He has found that
sweats an chills are indicative of co-infection. Fever of 102°F may
decrease infection. He discussed medications for these tbi and noted
findings of Dr. Brorson of Scandinavia regarding the effects of Flagyl
on the cystic form of Borrelia (Lyme) infection, stating that Flagyl
prevented cyst formation and degraded and ruptured cysts. He continued
in discussion of use of various antibiotics and their effects, eluding
to lack of response to Plaquinol being linked to possibly a stealth
virus. He recommended heat treatment, vitamins and a yeast free diet
in conjunction with aggressive antibiotic measures.

Joseph Burrascano, M.D. of East Hampton, NY was the final speaker. He
spoke of untreated and undertreated Lyme disease as cause of permanent
neurological damage including paraplegia, dementia, hearing and sight
loss. He stated that 1 month of amoxicillin (4-6 grams if needed) for
people with Lyme disease less than one year may be adequate but others
may find that they are not better six months to a year later. He stated
more than once that blood levels of antibiotics should be monitored to
make sure they are at therapeutic levels. He also stated that multiple
bites either at once or over a long period of time (undetected or
untreated) usually require more treatment than a single infectious
bite does. He spent the most time of all presenters on treatment
protocol, including vitamins and other supplements to boost
the immune system and exercise as tolerated. He recommended treatment
until the disease is no longer active, stating that rarely patients
need open-ended maintenance therapy.

Dr. Amiram Katz indicated a concern that researchers are not
investigating auto-immune symptoms that may be caused by Lyme disease
(not infection itself), i.e., demylenation of nerve tissue. His
presentation focused on Borrelia and it's effect on the central and
peripheral nervous systems. He outlined specific symptoms resultant of
such infection, diagnostic testing and then touched upon treatment
protocol, stating that in some cases, use of high dose steroids are
useful in conjunction with antibiotic treatment. He expressed concern
over lack of standardization for SPECT scan exposure and

About the author:
Nancy Berntsen, RN, BSN, Columbia, Connecticut. Nancy was diagnosed
with Lyme disease in 1994 having had symptoms since childhood.
She is a wife and mother of four boys, a home educator, and
coordinator of Tick-borne Illnesses Self-Help Alliance, Eastern
Connecticut, , [email protected] ,
[email protected]

Obtaining videos or a syllabus of the Conference:
The cost of a syllabus will be $20 or $25 dollars (depending on the
total amount printed), including shipping and handling (slightly more,
if being mailed outside the US.) This will probably not be available
for several months, but for those interested, please place your order
soon. Contact Sandy, [email protected] The video tapes can be
purchased for $25/set from the Lyme Disease Association of NJ,
PO Box 1438 Jackson, NJ 08527. However they will not be available for
several months. This is a subsidized price by the LDA-NJ to make it
affordable for everyone.


III.  ARTHRITIS RHEUM: Association of antibiotic treatment-resistant
     Lyme arthritis with T cell responses to dominant epitopes of
     outer surface protein A of Borrelia burgdorferi.
AUTHORS: Chen J, Field JA, Glickstein L, Molloy PJ, Huber BT, Steere AC
ORGANIZATION: Tufts University School of Medicine, Boston,
             Massachusetts, USA.
REFERENCE: Arthritis Rheum 1999 Sep;42(9):1813-22

OBJECTIVE: To explore further the association of antibiotic treatment-
resistant Lyme arthritis and T cell reactivity with outer surface
protein A (OspA) of Borrelia burgdorferi, including the
identification of T cell epitopes associated with this treatment-
resistant course.
METHODS: The responses of peripheral blood and, if available, synovial
fluid lymphocytes to B burgdorferi proteins, fragments, and synthetic
peptides, as determined by proliferation assay and interferon-gamma
production, were compared in 16 patients with treatment-responsive and
16 with treatment-resistant Lyme arthritis.
RESULTS: The maximum severity of joint swelling correlated directly
with the response to OspA. Moreover, the only significant difference
between patients with treatment-resistant and treatment-responsive
arthritis was in reactivity with N-terminal and C-terminal fragments
of OspA, OspA1 (amino acids [aa] 16-106), and OspA3 (aa 168-273).
Epitope mapping showed that 14 of the 16 patients with treatment-
resistant arthritis had responses to OspA peptides (usually 4 or

5 epitopes), whereas only 5 of the 16 patients with treatment-
responsive arthritis had reactivity with these peptides (usually 1 or
2 epitopes) (P = 0.003). Patients with HLA-DRB1 alleles associated
with treatment-resistant arthritis were more likely to react with
peptide 15 (aa 154-173) and, to a lesser degree, with peptide 21
(aa 214-233) than patients with other alleles, whereas the responses
to other epitopes were similar in both groups.
CONCLUSION: The maximum severity of joint swelling and the duration of
Lyme arthritis after antibiotic treatment are associated with T cell
responses to specific epitopes of OspA.


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