ΣΛβ Sigma Alpha Beta (Self Ass-Biters Society)
The
Weinstein Rule- Only 6 ton elephants may be diagnosed as elephants.
Nevermind pesky details like SPECIFIC trunks, ears, feet, and skin...
Arthur Weinstein's VaLiDaTiOns. This guy is the
methodological garbage generator of all
time. The
vaccine trials should never have been
carried out until the blot-reading
problem was resolved (3, below).
1)
Western Blot for Lyme, according to the
Weinstein VaLiDaTiOn CrItErIa:
Arthritis Rheum 1994
Aug;37(8):1206-11
Western blot band
intensity analysis. Application to the
diagnosis of Lyme arthritis.
Kowal K, Weinstein A.
New York Medical College,
Valhalla 10595.
OBJECTIVE. To determine the usefulness
of quantitative band-intensity analysis
of Western blots for the diagnosis of
Lyme arthritis. METHODS. IgG Western
blots for antibodies to Borrelia
burgdorferi were performed on sera from
39 patients with Lyme arthritis, 30
patients with syphilis, 50 patients with
connective tissue diseases, and 10
healthy individuals. Band positions and
band intensities were calculated using a
computerized image analysis system.
RESULTS. Lyme arthritis patients had
more bands and higher-intensity bands
than did non-Lyme patients. The presence
of at least 2 bands of moderate to high
intensity (> 40 optical units) or at
least 5 bands of lower intensity (> 20
optical units) was over 90% sensitive
and 100% specific for the diagnosis of
Lyme arthritis. A 60-kd band was present
in all Lyme arthritis patients. The
presence of an 83-, 39-, 21-, or 18-kd
band was highly specific for Lyme
arthritis. CONCLUSION. Band intensity
analysis increases the objectivity and
accuracy of Western blot interpretation
for the diagnosis of Lyme arthritis.
PMID: 8053960 [PubMed - indexed for
MEDLINE]
This
is the opposite of normal analytical
methods development criteria. He
is saying, that high antibody
concentration is a valid way to diagnose
Lyme disease. He is saying, the
higher the concentration of antibodies,
the more valid the test. The
opposite is the normal course of
analytical methods development.
The criteria for the USP is Sensitivity
(limit of detection, that means, "What
is the LOWEST concentration of analyte
that this method is good for?"),
Specificity (refers to only the analyte
in question), linearity (recovers
analyte predictably in and out of
matrix), Ruggedness (reproducible).
Lyme
arthritis is a different disease than
regular Lyme infection. Lyme
arthritis happens in those genetically
predisposed to reactive arthritis, and
Steere, in Rahn and Evans (Lyme
disease, Key Diseases Series, ACP, 1998),
states that seropositve Lyme, or Lyme
arthritis is part of the disease
process.
Steere and Immune
complexes
In Steere
and Dressler's prospective study, the
Dressler/Steere IgG criteria found
Steere's Lyme disease (LYMErix disease)
72% of the time, from those with
arthritis, and not from those with
Neuroborreliosis or the meningitis.
The data was this: 39/54.
So, this
Western Blot method is not even
especially accurate for persons who have
Steere's disease, or this Lyme
arthritis. 72%. That means
"back to the drawing board", in method
development. This method just
plain stinks, but it wasn't intended to
be valid. The VACCINES were
intended to be valid. They were
not. They were just one molecule
that is less often expressed in ticks
feeding on ~37º
C blood. OspC is upregulated at 37º C.
2)
The Fibromyalgia Impact Questionaire, as
"valid" for Lyme, according to the
Weinstein VaLiDaTiOn CrItErIa:
Arthritis Care Res 1999
Feb;12(1):42-7
The Fibromyalgia
Impact Questionnaire: a useful tool in
evaluating patients with post-Lyme
disease syndrome.
Fallon J, Bujak DI, Guardino S,
Weinstein A.
Leinhard School of Nursing, Pace
University, Pleasantville, New York,
USA.
OBJECTIVE: To determine the reliability
and validity of a modified version of
the Fibromyalgia Impact Questionnaire (FIQ)
in evaluating patients with post-Lyme
disease syndrome (PLDS). METHODS: In
this cross-sectional analysis 13 PLDS,
18 fibromyalgia (FM), and 16 healthy
controls (n = 47) completed a modified
FIQ containing items to evaluate
physical impairment, symptom severity,
and global well-being. Comparisons
between groups were done using analysis
of variance with a significance level
set at 0.05. RESULTS: PLDS patients
demonstrated statistically significantly
greater levels of impairment than
controls in physical functioning, FIQ
total score, global well-being, joint
pain, fatigue, depression, ability to
perform activities of daily living, and
memory/concentration. FM patients
demonstrated a statistically
significantly greater level of
impairment than the control group in all
categories, and the scores were
significantly higher than the PLDS group
in the measurement of physical
impairment, FIQ total score, muscle
pain, and joint pain. Overall, the
instrument possesses good reliability
and validity, although adequacy of this
instrument to measure impairment in the
male PLDS population needs further
elucidation. CONCLUSION: The results of
this study suggest that the modified FIQ
may be a useful tool in evaluating PLDS
patients. ***The findings suggest that
there may be some differences in the
etiopathology of the symptoms
experienced by PLDS and FM patients. ***
PMID: 10513489 [PubMed - indexed for
MEDLINE]
If
the validation shows a difference, it's
not valid, because it is not specific,
Specificity being a requirement of an
analytical method validation. The test can't test for something else,
otherwise it is not a specific test.
Besides, these guys came up with plenty of
markers of real disease on their own.
3)
Weinstein was in charge of Data
Integrity for the Connaught Vaccine
Trial. 'Head of the Data Safety
Monitoring. That would mean, he is
reponsible for data monitoring, while
Sigal ran this
trial of Barbour's Connaught vaccine.
The blots were not readable, according
to Sigal:
fter the conclusion
of the vaccine trials, one of the trial
adminstrators, Lenny Sigal, published that the data, the
results, the Western Blots used to
qualify the vaccines, the MarDx blots,
were actually unreadable:
http://www.journals.uchicago.edu/CID/journal/issues/v31n1/991200/991200.html
Detection of Multiple
Reactive Protein
Species by Immunoblotting
after Recombinant
Outer Surface
Protein A Lyme
Disease Vaccination
Philip J. Molloy,1,2
Victor P. Berardi,2
David H. Persing,2,3,a and Leonard H. Sigal4
1Rheumatology Associates of Southeastern
Massachusetts, Plymouth,
and 2IMUGEN, Norwood,
Massachusetts;
3Department of Laboratory Medicine
and Pathology,
Mayo Clinic, Rochester,
Minnesota; and 4Division
of Rheumatology,
Robert Wood Johnson
Medical School,
University of
Medicine and Dentistry
of New Jersey,
New Brunswick , Received 31 August 1999; revised 3
December 1999; electronically published
17 July 2000.
"...The
challenge then will be to determine which bands result
from recombinant OspA Lyme
disease vaccination and which
bands result from evolving
B. burgdorferi infection. In the
case of the FDA-approved
immunoblot test kit, the
identification of discrete bands
at molecular weights >30
kDa is often unreliable or impossible because of
the
homogeneous staining in this
area, compromising the ability of this test to
diagnose Lyme disease in
vaccinated study subjects. The manufacturer of the only
currently FDA-approved (and released) recombinant OspA Lyme
disease vaccine has suggested that
vaccination does not interfere with serological evaluation
of Lyme disease in vaccine recipients
a statement that is not supported by
the data
presented here."
Exactly how do you monitor data safety,
when you don't know what you are looking
at, and two years later, the leaders in
Blot development, Persing, Molloy and
Berardi (and Imugen and Steere and CT AG
Station, Magnarelli, etc.) publish that
after two YEARS, since the end of
the vaccine trials, they still don't
know what they are looking at?
What
could have been Weinstein's conclusions?
"Oh just never mind that overall
darkness in the blot. It just
means the blots are more valid,
according to the Weinstein Validation
Criteria..." ???
BLOT
SMUDGING:

 |
Figure 1. Results
of Western blotting (MarBlot for detection of IgG
antibody to Borrelia burgdorferi; MarDx, Carlsbad, CA) of serum specimens from 14 recipients of the
recombinant outer surface protein A Lyme disease vaccine. Representative molecular weights (in kDa) are identified in the far left column. P, a positive control subject with PCR analysis positive
Lyme arthritis; N, a negative control subject. Study subjects 1 10:
A, baseline; B, 30 days after dose 3.
Study subjects 11 14:
A, baseline; C, 30 days after dose 2; D, 8 months after dose 3; E, 24 months
after dose 3. |
 |
Figure 2. Results
of an alternate methodology for Western blotting (WB)
of serum specimens from the same 14 study subjects in
figure 1 who received the recombinant outer
surface protein A (OspA) Lyme disease vaccine. Top
portion of the figure represents WB with use of a
conventional Borrelia burgdorferi strain (G39/40), and bottom portion represents WB with use of a B.
burgdorferi strain lacking OspA expression. Representative
molecular weights (in kDa) are identified in the far
left column. P, a positive control with PCR
analysis positive Lyme arthritis; N, a negative control. Study
subjects 1 10:
A, baseline; B, 30 days after dose 3.
Study subjects 11 14: A, baseline; C, 30 days after dose 2; D, 8 months after dose 3; E, 24 months after dose 3. |
See the link to the full text
article, above.
I can't explain this. Neither
can anyone else. Weinstein should
have to explain it, since he proclaims
himself an expert in bioassay.
Crooks publishing a procedure
http://www.nccls.org/free/M34-A.PDF
======
Too
stunningly un-brilliant to even comment:
Lyme arthritis and
post-Lyme disease syndrome.
Weinstein A, Britchkov M.
Section of Rheumatology, Washington
Hospital Center, Washington, DC 20010,
USA. arthur.weinstein@medstar.net
In the United States, intermittent or
chronic mono- or oligoarthritis,
particularly affecting the knee, is the
most common manifestation of late Lyme
disease (LD). [FALSE- It
is the LEAST COMMON]
Lyme arthritis (LA) can usually be
prevented by early treatment of acute
LD. However, the erythema migrans rash
may go undetected in children and in the
dark skin of African Americans, leading
to delayed treatment and a relatively
increased incidence in LA. Virtually all
untreated patients with LA have high
levels of serum immunoglobulin G
antibodies, and sometimes low levels of
immunoglobulin M antibodies, to Borrelia
burgdorferi (Bb) by ELISA and Western
blot. These responses may persist for
many years after antibiotic treatment,
and therefore, serologic results do not
accurately distinguish between active or
past infection. [FALSE,
persisting and changing IgM means
persisting infection.] Most
patients with LA respond well to
standard courses of antibiotic
treatment, but a small percentage have
persistent knee synovitis, in some cases
possibly related to the triggering of
intrasynovial autoimmunity.
Other patients develop a syndrome of
diffuse arthralgia, myalgia, fatigue,
and subjective cognitive difficulty
during or soon after LD, which persists
despite antibiotic treatment. Patients
with this post-treatment, post-LD
syndrome were recently studied in a
placebo-controlled double-blind
antibiotic trial. There was no evidence
of Borrelial infection in these patients
by culture or detection of Bb DNA in
blood or spinal fluid. [False, the
correct primers were not used.]
Furthermore, there was no difference
in responsiveness of these patients to a
3-month course of antibiotic compared
with placebo treatment. [False, the
FIQ was not validated.] Thus, LA
caused by active Bb infection,
post-treatment LA with persistent knee
synovitis and post-LD syndrome are
distinct and distinguishable clinical
entities.
Lyme
arthritis vs.Neuroborreliosis.
Imagine. And after only 27 years.
Rebuttal:
http://www.ilads.org/stricker.htm