False Claims Act à Allen Steere’s 1993 blood testing standard for Lyme is completely bogus.
Therefore, all the US grants that were paid out upon that bogus standard, such as Klempner’s chronic Lyme “study,” were also false claims. The validity of the Yale Lyme vaccine qualification was a false claim, and they obviously knew it, since this is their earlier VALID diagnostic test.
The CDC's claim that they have a valid test for Lyme is 100% FALSE.
http://en.wikipedia.org/wiki/False_Claims_Act <--- False Claims Act
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27 Oct 2005
AAG John Tucker
860-808-5590
55 Elm, Hartford, 06106
VALIDATION OF YALE’S LYME
TEST
Dear Mr. Tucker-
Please take this to your
staff patent attorneys to confirm.
Verify independently that
this is the text of the Yale patent US
# 5, 618, 533
===========
This means they have the
ability to diagnose Lyme (borreliosis)
accurately and early but they chose
not to because they chose to make more
money on a bogus vaccine instead.
The "CLAIM" of the patent,
if you look at it, is a fragment of
DNA code, which means no one can use
this unless licensed by Yale- which
means they have a monopoly on
testing and they prefer we don't
have it available to us.
Yale’s own validation is
written within the claim of this
patent 5, 618,533 and is
well-described.
UCONN’s Henry Feder tested
the OspA vaccine on children in Europe
when he knew that would do them no
good and in fact, was harmful.
This vaccine never should have
gone to human trials.
Yale has an early and
accurate test for Lyme, but did not
use it, when all agree that early
treatment gives better patient
results.
This is CT’s disease.
We have children in CT.
Lyme borreliae can infect
the brain and does in 2/3 of the cases
(Dattwyler published data).
It kind of makes sense to
detect Lyme as early as possible to
prevent this infection from reaching
the brain and causing brain damage to
children.
The State’s resistance to
this concept is unforgivably
incompetent, abusive, and technically
is child abuse and medical neglect.
-
- -
The Yale Flagellin Patent
Validation is right in the text of
the patent:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/
netahtml/srchnum.htm&r=1&f=G&l=50&s1=5618533.WKU.&OS=PN/5618533&RS=PN/5618533
“The sera we used for these
studies were obtained from Lyme
disease patients, most of whom were
seen at the Lyme disease clinic of the
Department of Rheumatology, Yale
University School of Medicine. All
patients tested serologically positive
on a standard ELISA test using whole
sonicated B. burgdorferi as antigen.
In FIG. 3, patients 5, 8, 16 and 17
had ECM. Patients 2, 4-8, and 10-11
had chronic arthritis of greater than
6 months duration, patient 14 had
peripheral neuritis, patient 16 had
Bell's Palsey, patient 17 had severe
headache and patient 18 had
encephalopathy. Patients 1, 3, 9,
12-13 and 15 had arthritis.
As can be seen from FIG. 3,
a homogeneous response was observed
for most patient sera. Overlapping
fragments A and B and fragment D
define regions of generally low
reactivity. In contrast, seventeen of
18 patient's sera react strongly to
the overlapping fragments E, F, and G.
Fragments F and G are bound to
approximately the same
extent in all patients, and fragment H
is much more weakly bound.
Sera from two healthy
individuals (which also tested
negative for B. burgdorferi infection
in an ELISA) failed to react with any
of the fragments. Moreover, we
screened 10 additional control sera
for 41 kDA and fragment E reactivity
and all were negative (data not
shown.).
Fragments E, F, and G
define a region (amino acids 197-241)
that is highly reactive with anti-B.
burgdorferi antibodies in patient
sera, but which does not share
significant sequence homology to the
flagellins of Escherichia coli,
Salmonella typhimurium, Salmonella
rubislaw, Roseburia cecicola or
Serratia marcescens (except for four
of seven identical amino acids within
a short stretch defined by amino acids
209 to 215). Similarly, this region
contains only a short segment of
homology (four of 6 amino acids
identical between amino acids 211-216)
with the flagellin protein sequence of
Treponema pallidum [C. I. Champion et
al., "Cloning, Sequencing, And
Expression Of Two Class B
Endoflagellar Genes Of Treponema
pallidum subsp. pallidum Encoding The
34.5 And 31.0-Kilodalton Proteins",
Infect. Immun., 58, pp. 1697-1704
(1990)].
Accordingly, fragments E, F and
G should not show substantial
reactivity with antibodies directed
against other bacteria or treponemes,
and thus should represent
immunodominant regions that are useful
in the flagellin polypeptides of this
invention.
To confirm these findings,
we performed an immunoblot of
fragments A-K using sera from 11
patients with Treponema pallidum, the
agent of syphilis. The serum samples
were obtained from the Connecticut
State Laboratory. All the sera had
VDRL titers ranging from 1:4 to 1:128
and all were positive by specific
fluorescent antibody assay
(FTA). We chose syphilitic sera
because B. burgdorferi is closely
related to Treponema pallidum and
syphilis is the most common
spirochetal infection of humans in the
United States.
While 10 of the 11 sera
bound fragment 41-B, which contains 65
NH.sub.2 -terminal amino acids of
flagellin and thus represents a
conservative figure for the level of
binding one would expect to see for
the full-length flagellin antigen,
only two of the sera demonstrated
detectable binding to fragment 41G,
and that binding was very weak. After
prolonged exposure, weak binding to
the other fragments was detected.
We also tested the
diagnostic effectiveness of the
flagellin polypeptides of this
invention by ELISA. We coated
microtitration plates with 200
microliters per well of recombinant
41-G fusion protein (1 microgram/ml)
suspended in 0.05M sodium carbonate,
pH 9.6. We also used whole, sonicated
B. burgdorferi strain
297 as a coating antigen as
previously described [J. R. Craft et
al., "Antibody Response In Lyme
Disease: Evaluation Of Diagnostic
Tests", J. Inf. Dis., 149, pp. 789-95
(1984)]. We incubated the plates at
4.degree. C. overnight, then washed
with PBS containing 0.05% Tween-20 (PBST).
The patient sera we used were
diluted 1:100 in PBST and
applied in triplicate to each
antigen-coated plate at 200 micrograms
per well. Plates were then incubated
at room temperature for 75 minutes. We
then washed the plates three times
with PBST. For detection of bound
antibody, goat anti-human mu chain
alkaline phosphatase conjugate (Sigma)
was diluted 1:1000 in PBST and applied
at 200 microliters per well to the
appropriate plates. We then incubated
the plates at room temperature for 45
minutes. After three washes in PBST,
p-nitrophenyl phosphate was added to
each
well. The production of p-nitrophenyl
was monitored at 405 nm and the
reaction stopped with 3M NaOH when the
appropriate positive control wells
reached an optical density (A405
value) of 1.0 to 1.5. We calculated
the numerical values of the antibody
response of patients' sera to each
antigen by comparison to standard
curves established on each antigen
using known positive Lyme disease sera
as previously described (J. R. Craft
et al. supra).
Briefly, we established
standard curves, using serial 2-fold
dilutions of known IgM and IgG
positive Lyme disease sera, for each
antigen, with patients' sera applied
to the same plates. In addition, eight
known normal sera were run on the same
plate, each at a 1:100 dilution; the
mean A405 value of these eight sera
was set as the cut-off A405 value. The
first serial dilution of the standard
positive sample that exceeded this
cut-off value was assigned a value of
100 antibody units, and a curve
relating A405 value to antibody units
was established on this basis. The
average A405 value for each patient
serum was then compared to the
standard curve and a value of antibody
units was assigned to each serum on
the basis of this comparison. A
negative titer was <100 units,
and titers of 200 to 400
represent reactivity compared to
control, positive serum at subsequent
2-fold dilutions. We tested some of
the serum samples a minimum of 2 times
on separate occasions and in each
instance there was never more than a
2-fold difference in the measured
antibody levels.
Of the eleven syphilitic
serum samples, three (having VDRL
titers of 1:8, 1:32 and 1:128) showed
weak reactivity with B. burgdorferi,
yet none showed reactivity with the
41-G fragment.
Thus, a flagellin
polypeptide comprising an
immunodominant region corresponding to
fragment 41G is highly specific and
highly sensitive as well.
In other ELISAs to detect
the presence of anti-B. burgdorferi
antibodies, we found a high
correlation in test results using
whole spirochete extract or 41-G as
the substrate. However, in a small
number of patients, some discrepancies
in results yielded by various
substrates were noted. Over half of
the "discrepant" results occurred with
values just above the positive
cut-off. Accordingly, as with any
diagnostic assay, the sensitivity of
diagnostic assays utilizing the
flagellin polypeptides of this
invention should be rigorously
standardized….”
What that means is that
there is no arguing the validity of my
claim that Yale committed a crime.
This is their own patent claim
and validation.
You should
be investigating and prosecuting this
and not me.
LymeRIX was scientific fraud.
I have already given several of
the State’s Attorneys this data. I gave AAG Tom Ryan
the Dearborn booklet and the old CDC
published standard in the summer of
2003.
I have been in communication
with you before. I believe it was over
my complaint against the State to the
CT Commission on Human Rights in
Waterbury.
False Claims Act
à Allen Steere’s 1993
blood testing standard for Lyme.
All the US grants that were
paid out upon that bogus standard,
such as Klempner’s chronic Lyme
“study” were also false claims.
The validity of the Yale Lyme
vaccine qualification was a false
claim, and they obviously knew it,
since this is their earlier VALID
diagnostic test.
http://whistleblowerlaws.com/protection.htm
I give the State the data,
the State is not supposed to harass
and abuse us, in response.
The potential claims against
Yale are huge.
Yale cannot say the above is
not a validation:
It is Accurate, Specific, Early
and tested empirically in the field.
KMDickson
CC:
Gonzales, Chertoff, Goss, Mueller,
Rendell, Sheller, Blumenthal,
Milstein, McGuigan, Spitzer, Droney,
Dorsey, Chatigny, Torres, Fitzgerald