No response, Big shock (not)
July 26,
2000
To: Massachusetts Board of Registration
in Medicine
ATTN:
Consumer Protection Unit
10 West
Street, 3rd Floor
Boston, MA
02111
CC: Massachusetts Lyme Disease Coalition
P.O. Box
1916
Mashpee, MA
02649
Re: Allen
C. Steere, Jr., MD
From:
Kathleen M. Dickson
Southeastern CT Support Group
Facilitator
23 Garden
Street
Pawcatuck,
CT 06379
860-599-5451
I will
demonstrate that Allen Steere has a
nearly psychopathological indifference
towards patient outcomes as demonstrated
by his handling of Lyme disease
patients.
I will site
correspondence from him as well as some
journal abstracts that demonstrate this.
The
following letter was forwarded to me by
friends and occurred about a week or two
after I spoke with Victor Berardi,
Technical Director at Imugen, asking him
why they use Borelia burgdorferi (Bb)
strain FRG from Germany and G39/40 from
Guilford, CT., instead of the three CDC-
recommended strains of B31, 297, 2591
for Western Blotting (WB). I asked if
there was known antigenic variation, how
likely was it that SeCT and SwRI
patients would demonstrate strong
antibody production against OSPs from a
German strain? After much
biotechnobabble about protein
conformational folding and molecular
weight which seemed to support my point
of view, the conversation went nowhere.
However, I made the point that everyone
who is tested in their lab comes out
with a negative result.
I think it
more than coincidental that Steere and
Sikand were suddenly interested in new
strains (below) so soon after this
conversation, but they made no offer to
follow up on patients when it is known
that some strains are more virulent than
others (see abstracts below) to see if
they could identify the more valuable
strains for vaccine candidacy. Imugen is
in partnership with Corixa (see CRXA on
the NYSE for businessprofile) to
discover new vaccine candidates and
development of diagnostic test kits for
tick-borne diseases.
I argue
that it was careless of this team to not
ask patients to come back after 6 mos or
a year to determine of they had lasting
effects past the Rx'd abx regimen
offered. I also would like for you to
investigate the professional integrity
of Allen Steere as a treating physician,
researcher, paid advisor to insurance
companies and whether not his
association with LifeSpan, as an
employee constitutes a breach in medical
ethics.
Subject:
FW: CDC Lyme Disease Study
Date: 06
Jul 1999 08:17:14 -0400
From: Sssss@pfizer.com
To:
kathleen.dickson@snet.net
Kathleen:
mmmm asked
me to forward the message below to you.
ssss
______________________________ Forward
Header
Subject:
FW: CDC Lyme Disease Study
Author:
mmmm at Groton-CR
Date:
7/2/1999 3:17 PM
ssss,
Would you
be kind enough and forward this message
to Kathleen.
Thanks
mmmm
-----Original Message-----
From: MXXX,
Stacy L
Sent:
Friday, July 02, 1999 2:59 PM
To: DL-CRGRO-NC-ALL;
'#GRO_QAL_ALL'; #CR Groton 30 Day
Notices
Subject:
CDC Lyme Disease Study
This
summer, Dr. Vijay Sikand and Dr. Allen
Steere will be working on a CDC and NIH
supported Lyme Disease study for which
they are seeking patient volunteers.
This study has been approved by
Tufts/New England Medical Center's
Institutional Review Board.
They are
primarily interested in patients with
physician diagnosed erythema migrans, in
whom they will be studying pathogenesis
of disease, histopathology, molecular
and genetic diversity of Borrelia
burgdorferi isolates, cell-mediated
immune factors, and serology, in the
setting of clinical presentation. These
patients will have skin biopsy of the
lesion (small enough to be dressed with
a bandaid, no sutures) as well as
bloodwork on the day of presentation.
Lyme disease treatment will be initiated
at that time. Only one follow-up visit
is required for convalescent bloodwork,
2 to 4 weeks later. The grant
provides for a $100 payment to these
volunteers.
Since
specimens must be sent by overnight
courier to Boston, patients must be seen
no later than about 3:00 p.m.
Monday-Friday. Dr. Sikand's office is
located next door to Brooks Pharmacy at
Flanders Four Corners in East Lyme.
For more
information regarding this study, or if
you are interested in participating in
the study please contact Dr. Engelke at
X-16860.
===
If you
would like to verify with this Dr. EnXXX,
I am pretty sure the number is
860-441-XXXX, but please protect my
privacy/anonymity.
=======
========
1986 Steere
(The Early Days, before
the profitability of Vaccines and
Diagnostic tests was evident.):
Clinical
manifestations of Lyme disease.
Steere AC,
Bartenhagen NH, Craft JE, Hutchinson GJ,
Newman JH, Pachner AR, Rahn DW, Sigal LH,
Taylor E, Malawista SE
Zentralbl
Bakteriol Mikrobiol Hyg [A] 1986 Dec
263:1-2 201-5
Abstract
Lyme
disease typically begins with a unique
skin lesion, erythema chronicum migrans
(ECM) (stage 1). Patients with this
lesion may also have headache, meningeal
irritation, mild encephalopathy,
multiple annular secondary lesions,
malar or urticarial rash, generalized
lymphadenopathy and splenomegaly,
migratory musculoskeletal pain,
hepatitis, sore throat, non-productive
cough, conjunctivitis, periorbital
edema, or testicular swelling.
After a few weeks to months (stage 2),
about 15% of patients develop frank
neurologic abnormalities, including
meningitis, encephalitis, cranial
neuritis (including bilateral facial
palsy), motor or sensory
radiculoneuritis, mononeuritis
multiplex, or myelitis. At this time,
about 8% of patients develop cardiac
involvement--AV block, acute
myopericarditis, cardiomegaly, or
pancarditis. Throughout this stage, many
patients continue to experience
migratory musculoskeletal pain in
joints, tendons, bursae, muscle, or
bone. Months to years after disease
onset (stage 3), about 60% of patients
develop frank arthritis, which may be
intermittent or chronic. Recently
evidence suggests that Lyme disease may
also be associated with chronic
neurologic or skin involvement. Thus,
Lyme disease occurs in stages with
different clinical manifestations at
each stage, but the course of the
illness in each patient is highly
variable.
1994 Steere
(This report is
inconsistent with the next):
N Engl J
Med 1994 Jan 27;330(4):229-34
Detection
of Borrelia burgdorferi DNA by
polymerase chain reaction in synovial
fluid from patients with Lyme arthritis.
Nocton JJ,
Dressler F, Rutledge BJ, Rys PN, Persing
DH, Steere AC
Division of
Rheumatology/Immunology, New England
Medical Center, Boston, MA 02111.
BACKGROUND.
Borrelia burgdorferi is difficult to
detect in synovial fluid, which limits
our understanding of the pathogenesis of
Lyme arthritis, particularly when
arthritis persists despite antibiotic
therapy.
METHODS.
Using the polymerase chain reaction (PCR),
we attempted to detect B. burgdorferi
DNA in joint-fluid samples obtained over
a 17-year period. The samples were
tested in two separate laboratories with
four sets of primers and probes, three
of which target plasmid DNA that encodes
outer-surface protein A (OspA).
RESULTS.
B. burgdorferi DNA was detected in 75 of
88 patients with Lyme arthritis (85
percent) and in none of 64 control
patients. Each of the three OspA
primer-probe sets was sensitive, and the
results were moderately concordant in
the two laboratories (kappa = 0.54 to
0.73). Of 73 patients with Lyme
arthritis that was untreated or treated
with only short courses of oral
antibiotics, 70 (96 percent) had
positive PCR results. In contrast, of 19
patients who received either parenteral
antibiotics or long courses of oral
antibiotics (> or = 1 month), only 7 (37
percent) had positive tests (P < 0.001).
None of these seven patients had
received more than two months of oral
antibiotic treatment or more than three
weeks of intravenous antibiotic
treatment. Of 10 patients with chronic
arthritis (continuous joint inflammation
for one year or more) despite multiple
courses of antibiotics, 7 had
consistently negative tests in samples
obtained three months to two years after
treatment.
CONCLUSIONS. PCR testing can detect B.
burgdorferi DNA in synovial fluid. This
test may be able to show whether Lyme
arthritis that persists after antibiotic
treatment is due to persistence of the
spirochete.
1999
Steere:
Arthritis
Rheum 1999 Dec;42(12):2705-9
Lack of
Borrelia burgdorferi DNA in synovial
samples from patients with antibiotic
treatment-resistant Lyme arthritis.
Carlson D,
Hernandez J, Bloom BJ, Coburn J, Aversa
JM, Steere AC
Tufts
University School of Medicine, New
England Medical Center, Tupper Research
Institute, Boston, Massachusetts 02111,
USA.
OBJECTIVE:
To determine whether Borrelia
burgdorferi DNA may be detected in
synovial tissue from patients with Lyme
arthritis who have persistent synovial
inflammation after antibiotic treatment.
METHODS:
Synovial specimens obtained at
synovectomy from 26patients with
antibiotic treatment-resistant Lyme
arthritis and from 10 control subjects
were tested for B burgdorferi DNA using
3 primer-probe sets that target genes
encoding outer surface proteins A or B
or a flagellar protein (P41) of the
spirochete. RESULTS: The 26 patients
with Lyme arthritis, who had received
antibiotic therapy for a mean total
duration of 8 weeks prior to synovectomy,
and the 10 control subjects each had
negative polymerase chain reaction (PCR)
results in synovial samples. When the
samples were spiked with approximately
1-10 B burgdorferi, all but 1 had
positive PCR results, suggesting that
spirochetal DNA could have been detected
in most of the unspiked samples if it
had been present.
CONCLUSION:
These results indicate that synovial
inflammation may persist in some
patients with Lyme arthritis after the
apparent eradication of the spirochete
from the joint with antibiotic therapy.
So, which is it? 37% or
none?
1999 Ben Luft, et al,
identify strain variation playing a role
in antigenicity and pathology:
Genetics
1999 Jan;151(1):15-30
Genetic
diversity of ospC in a local population
of Borrelia burgdorferi sensu stricto.
Wang IN,
Dykhuizen DE, Qiu W, Dunn JJ, Bosler EM,
Luft BJ
Department
of Ecology and Evolution, State
University of New York, Stony Brook, New
York 11794-5245, USA.
The outer
surface protein, OspC, is highly
variable in Borrelia burgdorferi sensu
stricto, the agent of Lyme disease. We
have shown that even within a single
population OspC is highly variable. The
variation of ospA and ospC in the 40
infected deer ticks collected from a
single site on Shelter Island, New York,
was determined using PCR-SSCP. There is
very strong apparent linkage
disequilibrium between ospA and ospC
alleles, even though they are located on
separate plasmids. Thirteen discernible
SSCP mobility classes for ospC were
identified and the DNA sequence for each
was determined. These sequences,
combined with 40 GenBank sequences,
allow us to define 19 major ospC groups.
Sequences within a major ospC group are,
on average, <1% different from each
other, while sequences between major
ospC groups are, on average,
approximately 20% different. The tick
sample contains 11 major ospC groups,
GenBank contains 16 groups, with 8
groups found in both samples. Thus, the
ospC variation within a local population
is almost as great as the variation of a
similar-sized sample of the entire
species. The Ewens-Watterson-Slatkin
test of allele frequency showed
significant deviation from the neutral
expectation, indicating balancing
selection for these major ospC groups.
The variation represented by major ospC
groups needs to be considered if the
OspC protein is to be used as a
serodiagnostic antigen or a vaccine.
1999 (July) Ray
Dattwyler, et al Demonstrate that strain
variation plays a role in antigenicity
and pathology:
Infect
Immun 1999 Jul;67(7):3518-24
Four clones
of Borrelia burgdorferi sensu stricto
cause invasive infection in humans.
Seinost G,
Dykhuizen DE, Dattwyler RJ, Golde WT,
Dunn JJ, Wang IN, Wormser GP, Schriefer
ME, Luft BJ
Department
of Medicine, State University of New
York at Stony Brook, Stony Brook, New
York 11794, USA.
Lyme
disease begins at the site of a tick
bite, producing a primary infection with
spread of the organism to secondary
sites occurring early in the course of
infection. A major outer surface protein
expressed by the spirochete early in
infection is outer surface protein C
(OspC). In Borrelia burgdorferi sensu
stricto, OspC is highly variable. Based
on sequence divergence, alleles of ospC
can be divided into 21 major groups. To
assess whether strain differences
defined by ospC group are linked to
invasiveness and pathogenicity, we
compared the frequency distributions of
major ospC groups from ticks, from the
primary erythema migrans skin lesion,
and from secondary sites, principally
from blood and spinal fluid. The
frequency distribution of ospC groups
from ticks is significantly different
from that from primary sites, which in
turn is significantly different from
that from secondary sites. The major
groups A, B, I, and K had higher
frequencies in the primary sites than in
ticks and were the only groups found in
secondary sites. We define three
categories of major ospC groups: one
that is common in ticks but very rarely
if ever causes human disease, a second
that causes only local infection at the
tick bite site, and a third that causes
systemic disease. The finding that all
systemic B. burgdorferi sensu stricto
infections are associated with four ospC
groups has importance in the diagnosis,
treatment, and prevention of Lyme
disease.
=====
I checked for nucleotide
sequence similarity of major OSPs in
B31, 297, 2591 and FRG and/or G39/40 in
the Pasteur Institute Molecular Genetics
Server for Bb and did not find these
latter two strains listed.
I think there is enough
evidence to say that identification of
new strains (DNA patent) and a follow up
on patient outcomes past the 2-4 week
serological look (test kit) would have
been prudent and that this statement
reflects a broad and general attitude of
intended negligence.
Berardi:
Persistent Lyme Athritis is due to
persistent infection.
Ann Intern
Med 1986 Jun;104(6):798-800
Borrelia
burgdorferi in joint fluid in chronic
Lyme arthritis.
Snydman DR,
Schenkein DP, Berardi VP, Lastavica CC,
Pariser KM
Although
indirect evidence suggests that chronic
Lyme arthritis is caused by persistent
infection with Borrelia burgdorferi,
direct visualization has been lacking.
We report the demonstration of B.
burgdorferi from synovial fluid
aspirated from the right knee of a
31-year-old man with Lyme arthritis for
more than 1 year. After 6 days, culture
medium inoculated with synovial fluid
showed one motile and several nonmotile
spirochetes. Direct immunofluorescence
staining showed reactivity with anti-B.
burgdorferi serum. Spirochetes were not
seen in subcultured material. The
patient's arthritis improved with
high-dose intravenous penicillin.
Identification of B. burgdorferi from
the joint fluid of a patient with
long-standing arthritis supports the
concept that the arthritis is due to
persistent infection.
More
Berardi, no abstract available:
Zentralbl
Bakteriol Mikrobiol Hyg [A] 1986
Dec;263(1-2):288
Demonstration of Borrelia burgdorferi in
a patient with chronic Lyme arthritis.
Lastavica
CC, Snydman DR, Schenkein DP, **Berardi
VP**, Pariser KM
PMID:
3554842, UI: 87208551
Berardi and
Steere: Degree of cross-reactivity with
antibody-capture method.
J Infect
Dis 1988 Oct;158(4):754-60
Serodiagnosis of early Lyme disease:
analysis of IgM and IgG antibody
responses by using an antibody-capture
enzyme immunoassay.
Berardi VP,
Weeks KE, Steere AC , Department
of Virology, Center for Disease Control,
Boston, Massachusetts 02130.
We used an
antibody-capture enzyme immunoassay (EIA)
to evaluate the early antibody responses
to Borrelia burgdorferi in paired sera
from 30 patients with erythema chronicum
migrans. During acute disease, 20 (67%)
patients had elevated specific IgM
responses, and by convalescence (one to
four weeks after treatment), 28 (93%)
patients had increased IgM or IgG
responses. In acute specimens, elevated
IgM responses correlated with
disseminated infection; however, by
convalescence, most patients with either
localized or disseminated disease had
positive tests. Among 133 control
subjects, IgM cross-reactivity was
observed in 4 of 37 patients with either
Epstein-Barr virus or rickettsial
infections, and false-positive IgG tests
were seen in 8 of 28 patients with
syphilis. With antibody-capture EIA, the
diagnosis of Lyme disease can be
confirmed in the majority of acutely ill
patients and in almost all patients by
convalescence.
Steere and
Berardi: Observing but not treating
patients in the USSR.
J Infect
Dis 1988 Oct;158(4):748-53
Lyme
borreliosis in the Soviet Union: a
cooperative US-USSR report.
Dekonenko
EJ, Steere AC, Berardi VP, Kravchuk LN
Poliomyelitis Institute, Moscow, Union
of Soviet Socialist Republics.
We
identified 90 patients with tick-borne
erythema migrans in the Union of Soviet
Socialist Republics (USSR) in areas from
the western Baltic Republics to the
Maritime Territory on the Pacific Ocean.
Symptoms associated with the erythema
included fever, malaise and fatigue,
headache, myalgias, arthralgias, or
regional lymphadenopathy. Within two
weeks to four months, 58 (64%) of the
patients developed neurological
abnormalities, particularly radicular
pain, cranial neuritis, or lymphocytic
meningitis, and four (4%) patients
developed monoarticular or
oligoarticular arthritis. We tested the
sera from 35 Soviet patients by using an
isolate from the United States. The
serological data showed elevated IgM
and/or IgG antibody titers to Borrelia
burgdorferi in 2 of 10 patients with
erythema migrans, 15 of 21 with
neurological abnormalities, and 2 of 4
with arthritis. Our observations suggest
that Lyme borreliosis occurs in diverse
areas of the USSR.
They brought their own
Borrelia, and it looks like they only
observed and did not treat patients.
This demonstrated the accuracy of using
US strains in the USSR. It is not an
accurate test.] We would like you to
investigate whether Allen Steere is
using the CDC-recommended strains fo
Borreia in his curtrent 4.5 million
dollar grant study of Chronic Lyme
Disease.
More
Berardi:
N Engl J
Med 1989 Jan 19;320(3):133-7
Rapid
emergence of a focal epidemic of Lyme
disease in coastal Massachusetts.
Lastavica
CC, Wilson ML, Berardi VP, Spielman A,
Deblinger RD
Department
of Community Health, Tufts University
School of Medicine, Boston, MA 02111.
We describe
a focal epidemic of Lyme disease, which
spread from a nature preserve and
affected an adjacent community of
permanent residents in coastal
Massachusetts. The attack rate from 1980
through 1987 was 35 percent among 190
residents living within 5 km of the
nature preserve and was greatest (66
percent) among those living closest to
the preserve. The risk of infection bore
little relation to sex or age. Late Lyme
disease, which clustered near the
preserve, occurred mainly in residents
infected early in the epidemic who did
not have a history of erythema migrans
and did not receive antibiotic therapy.
All the residents with serologic
evidence of infection had early or late
clinical manifestations of Lyme
disease, or both, during the period of
study. The seasonal risk of infection
was bimodal--greatest in June, with a
secondary peak in October--and
corresponded to periods of increased
transmission. In the nature preserve,
the density of the vector tick, Ixodes
dammini, exceeded that in other New
England sites. The zoonosis rapidly
became endemic, and the severity of its
impact correlated with the abundance of
deer. This epidemic of Lyme disease
demonstrated that outbreaks can be focal
and can spread rapidly within a
community of permanent residents.
[This does
not mean that patients with early or
late clinical manifestations of Lyme
disease were seropositive, just that the
seropositive patients had clinical
signs. There is an important difference:
Seronegative Lyme exists. See Next:]
"Seronegative Lyme disease. Dissociation
of specific T- and B-lymphocyte
responses to Borrelia burgdorferi [see
comments]
*Dattwyler
RJ*, Volkman DJ, Luft BJ, Halperin JJ,
Thomas J, Golightly MG N Engl J Med 1988
Dec 1 319:22 1441-6
ABSTRACT:
The diagnosis of Lyme disease often
depends on the measurement of serum
antibodies to Borrelia burgdorferi, the
spirochete that causes this disorder.
Although prompt treatment with
antibiotics may abrogate the antibody
response to the infection, symptoms
persist in some patients. We studied 17
patients who had presented with acute
Lyme disease and received prompt
treatment with oral antibiotics, but in
whom chronic Lyme disease subsequently
developed. Although these patients had
clinically active disease, none had
diagnostic levels of antibodies to B.
burgdorferi on either a standard
enzyme-linked immunosorbent assay or
immunofluorescence assay. On Western
blot analysis, the level of
immunoglobulin reactivity against B.
burgdorferi in serum from these patients
was no greater than that in serum from
normal controls. The patients had a
vigorous T-cell proliferative response
to whole B. burgdorferi, with a mean (
+/- SEM) stimulation index of 17.8 +/-
3.3, similar to that (15.8 +/- 3.2) in
18 patients with chronic Lyme disease
who had detectable antibodies. The
T-cell response of both groups was
greater than that of a control group of
healthy subjects (3.1 +/- 0.5; P less
than 0.001).
We conclude
that the presence of chronic Lyme
disease cannot be excluded by the
absence of antibodies against B.
burgdorferi and that a specific T-cell
blastogenic response to B. burgdorferi
is evidence of infection in seronegative
patients with clinical indications of
chronic Lyme disease."
1990 Steere
in West Germany
[Half the US patients had no intrathecal
antibody response. This study have been
the source of FRG- Berardi may have been
there]
J Infect
Dis 1990 Jun;161(6):1203-9
Evaluation
of the intrathecal antibody response to
Borrelia burgdorferi as a diagnostic
test for Lyme neuroborreliosis.
Steere AC,
Berardi VP, Weeks KE, Logigian EL,
Ackermann R
Division of
Rheumatology/Immunology, New England
Medical Center, Tufts University School
of Medicine, Boston, MA 02111.
The
intrathecal antibody response to
Borrelia burgdorferi was evaluated in
American and West German patients with
Lyme neuroborreliosis. By an antibody
capture enzyme immunoassay, 12 (92%) of
13 patients from the USA with Lyme
meningitis were found to have
intrathecal antibody production to B.
burgdorferi, usually of multiple
isotypes, most commonly IgA. Of 12
patients with putative late central
nervous system manifestations of Lyme
disease, 5 (42%) had local production of
IgG or IgA spirochetal antibody, but
cerebrospinal fluid (CSF) abnormalities
could not be demonstrated in 6 patients
with late peripheral nervous system
manifestations of the disorder. Compared
with American patients, 30 European
patients with neuroborreliosis had
significantly higher CSF:serum ratios of
specific antibody both early and late in
the illness. Intrathecal antibody
determinations are the most specific
diagnostic test currently available for
Lyme neuroborreliosis, but local
antibody production in CSF is an
inconsistent finding in American
patients with late neurologic
manifestations of the disorder.
1996
Berardi on Labs NO ABSTRACT
Arch Pathol
Lab Med 1996 Apr;120(4):323-5
Proficiency
testing program for Lyme disease.
Seder RH,
Berardi VP
Publication
Types: Comment Letter
Comment on:
Arch Pathol Lab Med 1994
May;118(5):501-5
[The
comment is not available.]
Long term
Outcome Study Number 1 of 2
Conflicting
results.
Ann Intern
Med 1994 Oct 15;121(8):560-
The
long-term clinical outcomes of Lyme
disease. A population-based
retrospective cohort study.
Shadick NA,
Phillips CB, Logigian EL, Steere AC,
Kaplan RF, Berardi VP, Duray PH, Larson
MG, Wright EA, Ginsburg KS, et al
Department
of Rheumatology-Immunology, Brigham &
Women's Hospital, Boston, MA 02115.
OBJECTIVE:
To ascertain the prevalence of and risk
factors for long-term sequelae from
acute Lyme disease.
DESIGN:
Population-based, retrospective cohort
study.
SETTING: A
coastal region endemic for Lyme disease.
PARTICIPANTS: Patients with a history of
Lyme disease who were previously treated
with antibiotics were compared with
randomly selected controls.
MEASUREMENTS: A standardized physical
examination, health status measure
(Short Form 36), psychometric test
battery, and serologic analysis.
RESULTS:
Compared with the control group (n =
43), the Lyme group (n = 38; mean
duration from disease onset to study
evaluation, 6.2 years) had more
arthralgias (61% compared with 16%; P <
0.0001); distal paresthesias (16%
compared with 2%; P = 0.03);
concentration difficulties (16% compared
with 2%; P = 0.03); and fatigue (26%
compared with 9%; P = 0.04), and they
had poorer global health status scores
(P = 0.04). The Lyme group also had more
abnormal joints (P = 0.02) and more
verbal memory deficits (P = 0.01) than
did the control group. Overall, 13
patients (34%; 95% CI, 19% to 49%) had
long-term sequelae from Lyme disease
(arthritis or recurrent arthralgias [n =
6], neurocognitive impairment [n = 4],
and neuropathy or myelopathy [n = 3]).
Compared with controls, patients who had
long-term sequelae had higher IgG
antibody titers to the spirochete (P =
0.03) and received treatment later (34.5
months compared with 2.7 months; P <
0.0001).
CONCLUSIONS: Persons with a history of
Lyme disease have more musculoskeletal
impairment and a higher prevalence of
verbal memory impairment when compared
with those without a history of Lyme
disease. Our findings suggest that
disseminated Lyme disease may be
associated with long-term morbidity.
Comments:
Comment in:
Ann Intern Med 1995 Jun
15;122(12):960-1; discussion 961-2
Comment in:
Ann Intern Med 1995 Jun 15;122(12):961;
discussion 961-2
Long Term
Outcome Study Numbr 2 of 2
Ann Intern
Med 1999 Dec 21;131(12):919-26
Musculoskeletal and neurologic outcomes
in patients with previously treated Lyme
disease.
Shadick NA,
Phillips CB, Sangha O, Logigian EL,
Kaplan RF, Wright EA, Fossel AH, Fossel
K, Berardi V, Lew RA, Liang MH
Harvard
Medical School and Brigham and Women's
Hospital, Boston, Massachusetts 02115,
USA.
BACKGROUND:
Previous follow-up studies of patients
with Lyme disease suggest that
disseminated infection may be associated
with long-term neurologic and
musculoskeletal were treated for Lyme
disease in the late 1980s. DESIGN:
Population-based, retrospective cohort
study. SETTING: Nantucket Island,
Massachusetts. PARTICIPANTS: 186
persons who had a history of Lyme
disease (case-patients) and 167 persons
who did not (controls).
MEASUREMENTS: Standardized medical
history, physical examination,
functional status measure (Medical
Outcomes Study 36-item Short Form Health
Survey [SF-36]), mood state assessment
(Profile of Mood States), neurocognitive
tests, and serologic examination.
RESULTS: The prevalence of Lyme disease
among adults on Nantucket Island was
estimated to be 14.3% (95% CI, 9.3% to
19.1%). In multivariate analyses,
persons with previous Lyme disease (mean
time from infection to study evaluation,
6.0 years) had more joint pain (odds
ratio for having joint pain in any
joint, 2.1 [CI, 1.2 to 3.5]; P = 0.007),
more symptoms of memory impairment (odds
ratio for having any memory problem, 1.9
[CI, 1.1 to 3.5]; P = 0.003), and poorer
functional status due to pain (odds
ratio for 1 point on the SF-36 scale,
1.02 [CI, 1.01 to 1.03]; P < 0.001)
than persons without previous Lyme
disease. However, on physical
examination, case-patients and controls
did not differ in musculoskeletal
abnormalities, neurologic abnormalities,
or neurocognitive performance. Persons
with previous Lyme disease who had
persistent symptoms after receiving
treatment (n = 67) were more likely than
those who had completely recovered to
have had fever, headache,
photosensitivity, or neck stiffness
during their acute illness (87% compared
with 13%; odds ratio, 2.4 [CI, 1.0 to
5.5]; P = 0.045); however, the
performance of the two groups on
neurocognitive tests did not
significantly differ.
CONCLUSIONS: Because persons with
previous Lyme disease exhibited no
sequelae on physical examination and
neurocognitive tests a mean of 6.0 years
after infection, musculoskeletal and
neurocognitive outcomes seem to be
favorable. However, long-term impairment
of functional status can occur.
So which is it?
Does this mean 67 out of
186 continued to have symptoms despite
being treated (30%) and two thirds of
all patients had memory impairment? This
supports the conclusion that early
severe neurological symptoms are
associated with continued symptoms, yet,
last summer Steere and Sikand did not
offer to follow up on these patients. He
is aware of strain variation affecting
severity of illness from his own West
German study. Steere has a history of
psychopathological indifference to
patient outcomes. I believe his results
do not reflect his data.
A final
tidbit-Addressing the issues of strain
variation:
Anon wrote:
Hematol
Oncol 1999 Sep;17(3):107-16
Positive
serology for lyme disease borrelias in
primary cutaneous B-cell lymphoma: a
study in 22 patients; is it a fortuitous
finding?
Jelic S,
Filipovic-Ljeskovic I Institut za
Onkologiju i Radiologiju Srbije,
Belgrade, Yugoslavia.
BACKGROUND:
The historical association of
acrodermatitis chronica atrophicans (ACA),
now known to be a late manifestation of
Lyme disease caused by Borrelia afzelii,
with cutaneous lymphoma, and several
small series of PCBCL with positive Lyme
disease borrelial serology initiated a
study of this association. Material and
methods In the last 9 years, 30 patients
with PCBCL have been observed and
followed, 22 of them were tested for
borrelial serology. The control group
consisted of 85 patients with NHL (10
cutaneous T-cell, 25 extranodal B-cell
non-PCBCL, 50 nodal B-cell), 30 patients
with breast cancer and 60 blood donors.
The screening tests were two different
ELISA tests for B. burgdorferi sensu
lato and sensu stricto, and reactive
sera were further tested with the ELISA
test for B. garinii, a Western blot (WB)
test for Swiss Borrelia strains and a WB
test for Bavarian Borrelia strains,
***since an immunoblot made with local
strains was not available***.
Studies with a differential WB test for
B. burgdorferi sensu stricto, B. garinii
and B. afzelii was performed afterwards,
as well as serological studies ruling
out cross-reactions with Leptospiras and
Treponema. RESULTS: Fifteen of 22
patients with PCBCL were positive on the
screening tests, three of them falsely.
This shows that it is
recognized that one should ue local
strains to WB patient sera.
Test-treatment strategies for patients
suspected of having Lyme disease: a
cost-effectiveness analysis.
Nichol G;
Dennis DT; Steere AC; Lightfoot R; Wells
G; Shea B; Tugwell P Ottawa Civic
Hospital, Ontario, Canada.
Ann Intern
Med 1998 Jan 1;128(1):37-48
ABSTRACT:
PURPOSE: To examine the
cost-effectiveness of test-treatment
strategies for patients suspected of
having Lyme disease. DATA SOURCES: The
medical literature was searched for
information on outcomes and costs.
Expert opinion was sought for
information on utilities.
STUDY SELECTION: Articles that described
patient population, diagnostic criteria,
dose and duration of therapy, and
criteria for assessment of outcomes.
DATA EXTRACTION: The decision analysis
evaluated the following strategies: 1)
no testing-no treatment; 2) testing with
enzyme-linked immunosorbent assay
(ELISA) followed by antibiotic treatment
of patients with positive results; 3)
two-step testing with ELISA followed by
Western blot and antibiotic treatment
for patients with positive results on
either test; and 4) empirical antibiotic
therapy. Three patient scenarios were
considered: myalgic symptoms, rash
resembling erythema migrans, and
recurrent oligoarticular inflammatory
arthritis. Results were calculated as
costs per quality- adjusted life-year
and were subjected to sensitivity
analysis. Adjustment was made for the
diagnostic value of common clinical
features of Lyme disease.
DATA SYNTHESIS: For myalgic symptoms
without other features suggestive of
Lyme disease, the no testing-no
treatment strategy was most economically
attractive (that is, had the most
favorable cost-effectiveness ratio). For
rash, empirical antibiotic therapy was
less costly and more effective than
other strategies. For oligoarticular
arthritis with a history of rash and
tick bite, two-step testing was
associated with the lowest
cost-effectiveness ratio. Testing with
ELISA and empirical antibiotic therapy
cost an additional $880,000 and $34,000
per quality-adjusted life-year,
respectively. For oligoarticular
arthritis with one or no other features
suggestive of Lyme disease, two-step
testing was most economically
attractive.
CONCLUSIONS: Neither testing nor
antibiotic treatment is cost-effective
if the pretest probability of Lyme
disease is low. Empirical antibiotic
therapy is recommended if the pretest
probability is high, and two-step
testing is recommended if the pretest
probability is intermediate.
It is utterly
preposterous for Allen Steere to have
been involved in a study in which the
hypothesis was that people have no
inherent privilege or right to choose
whether they should be evaluated and/ or
diagnosed or choose be treated. What is
an academician who "studies" the effects
of Lyme disease, here and abroad, doing
being involved in such a ridiculous,
immoral, unethical endeavor?
Was there, Is there,
some financial incentive to make such a
declaration which suggests that we, of
the ignorant non-MD masses, without the
intellectual capacity to make decisions
for ourselves need to have such a
decision made for us? A cost
effectiveness stuyd such as this was
clearly for the financial goals of
insurance companies. Was the study
sponsored by insurance companies? Please
investigate.
I point out to you that
the United States ratified the
International Human Rights Declaration.
In so doing, we U.S. citizens are
guaranteed the highest level of medical
care technology available to us.
International Covenant on Economic,
Social and Cultural Rights
http://www.unhchr.ch/html/menu3/b/a_cescr.htm
Adopted and
opened for signature, ratification and
accession by General Assembly resolution
2200A (XXI) of 16 December 1966 entry
into force 3 January 1976, in accordance
with article 27
http://www.un.org/Depts/Treaty/final/ts2/newfiles/part_boo/iv_boo/iv_3.html
ratified by
the United States of America October 5,
1977
Preamble
The States
Parties to the present Covenant,
Considering
that, in accordance with the principles
proclaimed in the Charter of the United
Nations, recognition of the inherent
dignity and of the equal and inalienable
rights of all members of the human
family is the foundation of freedom,
justice and peace in the world,
Recognizing
that these rights derive from the
inherent dignity of the human person,
Recognizing
that, in accordance with the Universal
Declaration of Human Rights, the ideal
of free human beings enjoying freedom
from fear and want can only be achieved
if conditions are created whereby
everyone may enjoy his economic, social
and cultural rights, as well as his
civil and political rights,
Article 12
1. The
States Parties to the present Covenant
recognize the right of everyone to the
enjoyment of the highest attainable
standard of physical and mental health.
It is the attitude of
Allen Steere that Lyme disease is
overdiagnosed and overtreated. In his
1993 JAMA study, he reassigns the
diagnoses of musculoskeletal and late
disseminated Lyme disease in patients
referred to him. He had no objective
proof that Lyme disease becomes and
autoimmune disease such as Fibromyalgia
or Chronic fatigue Syndrome, yet he
arbitrarily made this reclassification
and in so doing he deliberately denied
them care. We ask that you investigate
his laboratory notes and see what
strains of Borrelia he used to test
these patients.
He flip-flops in
reporting his on his long-term outcome
results.
At first, Lyme is a
serious disease, then it is not. Then he
can extract Borrelia DNA from synovial
fluid, then he can not.
He cannot be believed
regarding any statements he makes.
In a comment he made
about patients to the press it is clear
that he believes himself so superior to
patients. He was quoted in the Boston
Herald 11/3/99 as saying we are "Not
rational."
This statement is
discriminatory and is another violation
of the International Human Rights
Declaration in that it prevents Lyme
patients from having future objective
audience with medical professionals
27.
Principle 1.4 includes the following
provisions relating to improving the
cost-effectiveness of resource
allocation and health planning:
"With the
development of relatively new methods
for measuring the burden of disease on
human life that constitute potential
tools for guiding decisions for
improving the cost-effectiveness
(efficiency) of resource allocation and
health planning, it is essential that
the further refinement of these methods
be guided by the principles of equity
and non-discrimination on such grounds
as age, sex, ethnic origin, personal
status, etc., as well as efficiency, and
that countries with an interest in
applying these tools be provided with
the resources for building capacities
for undertaking these analyses in a
manner consonant with national and local
needs."
28. With
respect to applying bioethical concepts
to relevant aspects of human rights,
principle 2.1 states that:
"important
opportunities exist for applying
bioethics concept in developing the
content of human rights relating to
health, health protection, and health
care. Such rights can be clustered into
three categories, viz.:
- rights to
health care and to the benefits of
scientific progress;
- rights
relating to information, association,
and freedom of action that could empower
groups to protect and promote their
health; and
- rights
relating to self-determination and
integrity of the
person,
including rights to liberty and security
and the right to private life."
It is a
Human Rights Violation for him to
reassign our state of ill physical
health to be one of unfounded
psychiatric preoccupation. We have the
right to organize to protest his
disregard for the legitimacy of our
complaints.
You have in
your State of Massachusetts, someone
with a personality disorder that
reflects a pathological indifference to
human beings and is practicing something
other than medicine from Tufts
University. Please do investigate
whether the attitudes and practices of
Allen Steere are consistent with your
present and former interpretation of the
role of the physician in our society.
Kathleen M.
Dickson
Southeastern CT Support Group
Facilitator
23 Garden
Street
Pawcatuck,
CT 06379
860-599-5451