lyme.kaiserpapers.info
June 1, 2003Barbara
Johnson, Chief, Molecular Biology Section Centers for
Disease Control and Prevention Division of Vector-Borne
Infectious Diseases Bacterial Zoonoses Branch PO
Box 2087 Fort Collins, CO 80522 Re: HMO abuse of
Lyme disease surveillance case
definition Dear Dr. Johnson,
Early
last year, the U.S. Senate issued a
directive that the Centers
for Disease Control develop standards for Lyme disease in order to
prevent
the abuse of restrictive surveillance criteria for (non) diagnosis. I
wish
to bring your attention that Kaiser Permanente appears to have
repeatedly
abused surveillance criteria to deny diagnoses of Lyme disease.
Previously,
I had written David Lawrence, the former CEO of Kaiser Permanente to
make
him aware of the problem and offered to bring a number of patients to
meet
with him. Mr. Lawrence never responded to my offer.
I
am relating my experience to provide an example
to help the CDC in
formulating new standards. My experience is only one of many with this
HMO. If it would be helpful to you, I can provide many more detailed
accounts
of Lyme disease victims who were denied a diagnosis and care by Kaiser
Permanente. In my case, I believe the
refusal to diagnose was
deliberate and made
possible by inappropriate use of CDC guidelines. To illustrate the
lengths
to which clinicians at this HMO will go to deny a diagnosis, I am
enclosing
documentation pertinent to my own case. It should be noted that when I
told my former primary care physician that I suspected I had Lyme
disease,
he refused to give me an appointment despite many documented attempts
over
many weeks. The main facts are summarized below; - A “Chronology of
Symptoms” was constructed by me, primarily from information
in my medical records, and was a listing of new and unusual symptoms
following
my tick bite. The vast majority of these symptoms were consistent with
Lyme disease as stated in CDC/NIH criteria as well as other more
comprehensive
sources. My symptoms started after returning from a trip to Northern
California
in 1994, an area the CDC considers as one of three areas with the
highest
incidence of Lyme disease in the United States. My dog who came with me
on this trip was also infected and had many of the same symptoms, with
more severe arthritic complications, and eventually had to be
euthanized.
- This information was provided to the
infectious disease clinician who met
with me in June, 2000. The medical report written by this clinician
stated
that these symptoms, in his opinion, were not consistent with Lyme
disease.
In particular, he dismissed the erythema migrans that the NIH considers
to be the “hallmark” symptom of Lyme disease. He
also told me that an erythema
migrans could be caused by “many, many, many
diseases.” Three times I asked
him to name even one of these diseases. Three times he refused to
provide
an answer. He also refused any differential diagnosis. In brief, he
refused
to provide any help in any way. He supported his opinion by a negative
ELISA test from Kaiser’s laboratory.
- To
damage my credibility, he falsely wrote
in his medical report that I
stated I believed in Lyme “conspiracists,” his
non-word. The inspiration
for this lie came from the fact that I had provided him with a copy of
Dr. Joseph Burrascano’s then newly released treatment
guidelines. You may
recall that Dr. Burrascano gave a speech before the U.S. House of
Representatives
titled “The Lyme Conspiracy.” There was no
discussion of any kind concerning
conspiracies or anything of any remote resemblance during my encounter
with this clinician.
- In 2001, a neurologist at
Kaiser tried to
help me by ordering Western Blot
IgG and IgM tests and bypassing ELISA. He understood that the ELISA was
not an appropriate test for late-stage Lyme disease. I told him that I
had questions on the reliability of Kaiser’s contracted
laboratory, American
Medical Laboratories in Chantilly, VA, and would prefer to have the
test
performed at a reference laboratory experienced in tick-borne
infections.
He agreed to order the Western Blot tests from both labs as long as I
paid
for my lab of choice. He also wanted to do a side-by-side comparison of
the results from the two labs. At my request and expense, an IgG was
ordered
from the reference laboratory. A Western Blot IgG and IgM was ordered
through
Kaiser’s lab. His nurse read me the order that was entered
and it was exactly
as he stated, an ELISA was not ordered. When I went to have the blood
drawn,
this doctor’s orders were apparently blocked. I could have
the Kaiser Western
Blot tests only if the ELISA was positive. This is a surveillance
criterion
for cases of new infection. (The ELISA was, of course, once again
negative).
- The Western Blot IgG showed the presence
of
4 bands of positive intensity
and one band of equivocal intensity. One of the bands was OspA
according
to CDC criteria. The CDC surveillance criteria require 5 bands of
positive
intensity to meet the case definition. You must certainly be familiar
with
the trials done for the vaccine study showing that only 22% of proven
Lyme
cases are able to meet the 5 band IgG criteria. The neurologist who
challenged
the non-specific negative ELISA result with the IgG results was forced
to defer to the infectious disease clinicians. The same infectious
disease
clinician who denied my diagnosis, and a cohort, also dismissed the
Western
Blot IgG as significant stating that the results do not increase the
probability
that “he has active chronic Lyme disease in any organ
system.” They supported
this comment by the second negative ELISA test which was done by
Kaiser’s
contracted lab although the Western Blot is specific and more reliable.
This denial was in contradiction to the recommendation by the NIH that
the most appropriate serologic test for prior infection with Borrelia
burgdorferi,
the spirochete that causes Lyme disease, is the IgG western blot assay.
- In
response to a request asking what other
diseases could cause an erythema
migrans, the Chief of Infectious Diseases for this Kaiser Permanente
facility
wrote me a letter stating that my symptoms were likely due to other
health
problems and the erythema migrans I had was a self-limiting episode of
Lyme disease. I wrote a letter in response questioning how he have
concluded
that it was self-limiting, given my progression of symptoms and
positive
response to antibiotic treatment. Also, in the copies of the two
complaints
that were given to him, it was documented that I received a diagnosis
of
6th cranial nerve palsy from a Kaiser opthalmologist, yet another
symptom
consistent with Lyme disease indicating the infection had spread to my
central nervous system. I also attached a copy of a recent Western Blot
IgM that, in fact, exceeded CDC criteria in terms of the number of
bands
and specific bands.
- Both of my complaints were
dismissed with
no explanation. I received no
further response from Kaiser other than from the manager of the
infectious
diseases department essentially stating that my time to file additional
complaints or grievances through Kaiser had expired. I am informed that
one strategy employed by Kaiser is to delay and postpone until the
member’s
allowed time for complaints, grievances and arbitration have expired.
Patients
with late-stage Lyme disease are simply unable to file timely
grievances
because they are too sick to do so.
Kaiser’s refusal to correct my medical records
continues to
affect my health
care. There are others who have been through far worse than my
experience.
Some having to spend considerable sums to get tests and treatment that
should have been covered by Kaiser Permanente. This situation must be
corrected
and the CDC must do its part to prevent these abuses.
I would
like to bring your attention to a study
cited in CDC references.
It was a study apparently performed by Kaiser showing that of 117 cases
of suspected Lyme disease by both physicians and patients, only one
ELISA
test came back positive. The lab that was being used at the time of the
study was American Medical Laboratories in Virginia. This is the same
lab
where my samples were sent. The study samples were from a California
facility.
This skewed result may have been due to flawed specimen handling and
testing
rather than the strong implication that Lyme disease is
“rare” in California.
The latter conclusion is highly misleading as evidenced by recent
studies
on rates of nymphal tick infection which rival areas of the East Coast
in which Lyme disease is hyperendemic. Dr. Robert Lane of U.C.
– Berkeley
did these studies.
You might want to
reconsider the use of this
Kaiser study as a reference
in CDC information. And you may want to investigate why this laboratory
generated only one positive result out of 117 samples of suspected Lyme
disease. These samples were sent across the country, a practice
criticized
by the Infectious Diseases Society of America because of the high risk
of sample degradation. In fact, my samples were analyzed five or more
days
after being drawn compared to the laboratory specification of two days.
There appears to be a strong bias against
diagnosis for Lyme disease
at this institution. To summarize; - My primary care physician absolutely
refused to see me when I told him
I suspected I had Lyme disease.
- In issuing his
denial, the infectious
disease clinician I saw lied to me
and lied about me on my medical report. Differential diagnosis was
refused.
- The neurologist who tried to help me was
not allowed to bypass the CDC
ELISA surveillance requirement and order the Western Blot through
Kaiser’s
contracted laboratory.
- The presence of five bands
on Western Blot
IgG (paid by me) was dismissed
as evidence of Lyme disease. CDC/NIH diagnostic recommendations were
ignored.
- After all of the ongoing clinical and
serologic evidence and positive response
to antibiotic treatment, the Chief of Infectious Diseases at this
facility
suggested that my episode of Lyme disease may have been self-limiting.
He claimed he could not find my Western Blot IgG.
- My
complaints were dismissed without
explanation. CDC positive results
on Western Blot IgM were ignored.
Bias against diagnosing Lyme
disease is putting patients at additional
risk since it provides a basis for ignoring other tick-borne
infections.
The grievance procedures and binding arbitration requirements of this
HMO
have not been favorable to Lyme disease victims. You should know that
patients
enrolled in this HMO do not have the option of seeking help from an
outside
doctor unless they pay for it themselves or they are able to enroll in
another health plan. It has been suggested that an indictment be
prepared
against Kaiser regarding Lyme disease and signed by currently known
victims.
The true numbers of patients with Lyme disease that have been
undiagnosed
or misdiagnosed by Kaiser are not known. CDC criteria should
not be used as a platform for
deceit and denial
of medical care. Kaiser Permanente claims to have 11,000 physicians,
medical
expertise in all specialties, has a clinician on a CDC Lyme disease
committee,
and has an ex-CDC Director on the Board of Directors. Ignorance cannot
be claimed as an excuse. Unless the CDC heeds the
recommendation of the
U.S. Senate and takes
a more active stance in discouraging the use of the surveillance case
definition
for diagnosis, it is implicitly condoning the kind of behavior I have
outlined
in this letter. I cannot believe that this was the intention of the
CDC. Very Truly Yours,
Miguel A. Perez-Lizano
Cc;
Julie Gerberding, Director – Centers for
Disease Control and Prevention
Phillip Baker, Lyme Disease Program Officer – National
Institutes of
Health
George Halvorson, CEO, Kaiser Foundation Health Plan
Denise Honzel, Kaiser Permanente Northwest
Other interested parties
Enc;
Excerpts from Public Law 107-116 Signed by
President Bush 1/10/02
Chronology of Symptoms
Kaiser Permanente medical report dated 6/05/2000 (but submitted much
later)
Western Blot IgG
Comment of infectious disease clinicians regarding Western Blot IgG
dated 4/16/2001
Letter from KPNW Chief of Infectious Diseases dated 12/13/2001
Letter to KPNW Chief of Infectious Diseases dated 7/17/2002
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