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H.R. # 6140 92 31
Pt. Name: Miguel A. Perez-Lizano

PATIENT REBUTTAL for inclusion in patient’s medical record.

Date of Document: 4/16/2001

Type of Document: Staff message from Joseph Kane, M.D.

Rebuttal:

Joseph Kane, M.D. has added the following comment to my medical record as
a response to a physician’s inquiry;


"See Steve Spindel’s 6/5/2000 I.D. consultation. In view of Steve’s consultation
and repeated negative EIA testing, I do not believe that the equivocal result on
Western Blot test which we reviewed together increases the probability that
he has active chronic Lyme disease in any organ system. Thanks JK”


Selected comments:

1)  Dr. Kane is offering a second opinion. Protocols issued by the National 
Institutes of Health state that the diagnosis of Lyme disease is a clinical 
diagnosis. Dr. Kane has never met me, examined me, or spoken to me.
Dr. Kane is in not in compliance with NIH protocols.
 
2)  Dr. Kane relies on a report by Dr. Spindel to validate his opinion. Dr. Spindel’s
report is false, incompetent, and biased. A separate complaint and rebuttal has
been filed against Dr. Spindel.

3)  In March 2001, I ordered and paid for a Western Blot IgG blood test specific
for Lyme disease. The CDC developed highly restrictive criteria for the
surveillance reporting of Lyme disease. The criteria were meant to be definitive.
Ten antibodies reactive to Lyme (arthritis) disease were defined. (Dressler F,
Whalen JA, Reinhardt BN, Steere AC. Western Blotting in the serodiagnosis
of Lyme disease). The CDC considers the presence of five bands definitive.
My results were four positive bands and one band of equivocal band intensity.
Equivocal is a measure of band intensity, not an indication of probable
presence or absence of a band. An equivocal designation means the band is
present.

The CDC gives the following description concerning antigenic identity.
B. burgdorferi is made up of at least 30 different immunogenic proteins
including three major outer-surface proteins, Osp-A (30 kDa), Osp-B (34 kDa),
and Osp-C (23 kDa). The 41 kDa antigen, similar to that of other spirochetes,
is located on the flagellum. Other prominent antigens include the 18, 28, 35,
37, 39, 45, 58, 66, and 93 kDa antigens”. My results showed the presence of
the 30, 41, 45, 58, and 66 kDa antigens. Band 30 kDa was positive.


In the SmithKline Beecham clinical trials involving 11,000 patients, only 22%
of those with culture-proven Lyme disease (the “gold standard”) were able to
show the presence of five or more significant bands.


4)  For Dr. Kane to state that, in his opinion, the results of this test do not
increase the probability that I have active Lyme disease is not correct. Lyme
Western Blot IgG cannot distinguish between active and past infection. The
American Red Cross has issued guidelines that potential donors with past
or active Lyme disease or certain other tick borne diseases are prohibited
from donating blood. Dr. Kane’s statement strongly implying that I do not
have or have never had Lyme disease without ever having seen me or
ordering additional testing for tick borne diseases, for which many tests
are available, is a public health concern.


5)   Dr. Kane bases his opinion on the EIA (ELISA) test results. It is exten-
sively published in peer-reviewed literature that the ELISA is seriously flawed
as a diagnostic test for Lyme disease. In the Lyme vaccine clinical trials,
SmithKline Beecham demonstrated that 36% of the participants were culture
positive but seronegative. The Centers for Disease Control (CDC) gives the
ELISA a sensitivity of 64% using highly positive CDC banked blood speciments
(Johnson BJ, Robbins KE, Bailey RE, Cao BL, Suiat SL, Craven RB, Mayer RW,
Dennis DT; “Serodiagnosis of Lyme Disease: Accuracy of a two-step approach
using a flagella-based ELISA and immunoblotting”). A very large-scale study by
the American Pathologists Proficiency Testing Program showed that only 55%
of Lyme disease patients were correctly identified using CDC criteria for
seropositivity. Using these measures, the ELISA is 35% to 40% accurate at best.


According to Dr. Alan Barbour of the University of California at Irvine, formerly of
the NIH and regarded as a leading Lyme disease researcher, the ELISA has a
sensitivity of 20% to 60%. In addition, it is known that the ELISA is a particularly
poor test for late-stage Lyme disease. Knowledgeable clinicians and researchers
are aware of the limitations of ELISA as a test for Lyme disease.


The accuracy of Lyme ELISA testing by Kaiser’s contracted laboratory, American
Medical Laboratories (AML) in Chantilly, Virginia, could be questionable. Reference
criteria for West Coast strains differ from East Coast and European strains. The
West Coast tick is the Ixodes pacificus. The East Coast tick is the Ixodes dammini.
Comparing one against the other increases the probability of a false negative.
There is also a question whether Kaiser’s handling of blood samples from West
Coast facilities meet AML’s speciment requirements for handling and shipping.
An internal Kaiser study showed that of 117 samples sent from a California facility,
only one had a positive result.


6)  Dr. Kane uses the two-tier serodiagnosis surveillance criteria as diagnostic
criteria. This is also not compliant with NIH guidelines. The guidelines state,
“This (two-tier serodiagnostic) surveillance criteria was developed for the
national reporting of Lyme disease; it is NOT appropriate for clinical diagnosis.”
(The capital letters are directly from the NIH statement for diagnosis).


7)  The results of my Western Blot IgG test are completely opposed to and do
not support Dr. Kane’s opinion. While the Western Blot can be used to rule
out false ELISA positives, it is never used to rule out false ELISA negatives.



Patient Signature:


Miguel A. Perez-Lizano

Date:


Attachment:

Centers for Disease Control; Lyme Disease: The Bacterium

Cc:

David M. Lawrence, M.D.



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