I spoke to an officer in the infectious diseases section at the CDC on May 25,
2005. I inquired as to what steps the CDC has taken to correct the misuse of the
surveillance case definition, per Public Law 107-116 signed by President Bush on
January 10, 2002. The officer informed me that the CDC has received many calls
related to this issue, but the Law is merely a “recommendation” and not
required; therefore, the CDC has not done anything with regard to this issue. In
addition, in an email from this same officer on May 25, 2005, she referred me to
the state health department and the state medical board for physicians’
inappropriate misuse of the surveillance case definition.
As you will see by the Committee Report for Public Law 107-116 below, responsibility for alerting physicians regarding the misuse of the case surveillance definition falls squarely upon the shoulders of the CDC. This issue is directly affecting my life and the lives of thousands of other Lyme disease patients.
From the Congressional Report related to Public Law 107-116:
“The Committee is distressed in hearing of the
widespread misuse of the current Lyme disease surveillance case definition.
While the CDC does state that “this surveillance case definition was developed
for national reporting of Lyme disease: it is NOT appropriate for clinical
diagnosis,” the definition is reportedly misused as a standard of care for
healthcare reimbursement, product (test) development, medical licensing
hearings, and other legal cases. The CDC is encouraged to aggressively pursue
and correct the misuse of this definition. This includes issuing an alert to the
public and physicians, as well as actively issuing letters to places misusing
this definition.”
“The Committee recognizes that the current state of laboratory testing for Lyme
disease is very poor. The situation has led many people to be misdiagnosed and
delayed proper treatment. The vaccine clinical trial has documented that more
than one-third (36 percent) of the people with Lyme disease did not test
positive on the most sophisticated tests available. The ramifications of this
deficit in terms of unnecessary pain, suffering and cost is staggering. The
committee directs CDC to work closely with the Food and Drug
Administration to develop an unequivocal test for Lyme disease.”
In addition, according to the CDC Morbidity and Mortality Weekly Report from
August 11, 1995 / 44(31);590-591, which includes the Recommendations for Test
Performance and Interpretation from the Second National Conference on Serologic
Diagnosis of Lyme Disease, the diagnostic criteria implemented at that
conference is still being utilized by laboratories across the nation today
(except for the progressive highly-specialized tick-borne disease labs). At this
conference, the CDC, along with the other agencies listed in the Report,
eliminated from the Western Blot test two Borrelia burgdorferi bacteria
proteins, outer surface protein A (OspA – 31 kDa) and outer surface protein B (OspB
– 34kDa). It is my understanding that the OspA was the protein from which the
Lymerix vaccine (pulled from the market) was made, and the OspB was the intended
component of next-generation vaccines. This made sense for the vaccine trials,
but has had detrimental effect upon the chronically-ill Lyme disease patients
which no longer meet this vaccine-oriented diagnostic standard. This diagnostic
criteria is still being utilized by laboratories across the nation today,
THIRTEEN YEARS LATER!
Due to the mistaken practice of physicians relying strictly
upon blood tests for diagnosis, patients such as myself are excluded from diagnosis due to the
vaccine-oriented diagnostic criteria. As a result, we are excluded from treatment as well.
The results from my tests at IGeneX Lab in California show that on the Western
Blot IgM and IgG, I tested equivocal for OspA (31kDa) and low positive for OspB
(34kDa), along with other positive bands. My lab results from Sonora Quest-Quest Diagnostics in California show
that this lab only tests for the ten CDC-required bands, as compared with
sixteen bands at IGeneX. The Sonora Quest-Quest Diagnostics Western Blot did not
test me for OspA (31kDa) or OspB (34kDa). The Sonora Quest-Quest Diagnostics
test used the vaccine-oriented diagnostic criteria implemented at the Second
National Conference on Serologic Diagnosis of Lyme Disease. Which is the more
comprehensive test? In my opinion, IGeneX provides the most comprehensive
testing. However, physicians and health
departments refuse to accept as valid testing performed by IGeneX. IGeneX is a lab
that holds several certifications in several states including certification from Medicare.
The CDC, along with the Association of State and Territorial Public Health
Laboratory Directors, the Food and Drug Administration, the National Institutes
of Health, the Council of State and Territorial Epidemiologists, and the
National Committee for Clinical Laboratory Standards, REMOVED the OspA (31kDa)
and OspB (34kDa) from the diagnostic testing criteria at the Second National
Conference on Serologic Diagnosis of Lyme Disease held in October of 1994. It is
my belief that the decision to remove these two highly-specific bands of Borrelia burgdorferi were done to accommodate the Lymerix vaccine WHICH HAS
SUBSEQUENTLY BEEN REMOVED FROM THE MARKET! In addition, these highly
specific bands will not be put back into the laboratory testing criteria,
because these two bands are being utilized to create vaccines currently being
developed by pharmaceutical companies.
Several of the individuals who REPEATEDLY play key roles in establishing the testing criteria and the Lyme Disease Treatment and Practice Guidelines set forth by the Infectious Diseases Society of America (IDSA) are patent-holding, financial-interest-bearing individuals associated with the CDC, the NIH, Yale University, IDSA, certain biotechnology companies who provide supplies to aid in the development of vaccines, certain pharmaceutical companies developing vaccines, and companies who manufacture Lyme disease test kits based upon the biased testing criteria set forth at the Dearborn Conference.
The bottom line is this: The CDC, the FDA and the NIH are catering to an elite group of patent-holding, financial-interest-bearing individuals and the biotechnology and pharmaceutical companies they are associated with to develop vaccines for monetary gain. In addition, under the guise of standardizing laboratory testing criteria, these agencies have merely standardized the laboratory testing criteria to aid the marketing of standardized test kits for monetary gain. The actions of these agencies and individuals are detrimental to the health of patients suffering from chronic Lyme disease and co-infections. It is my opinion that these agencies should place the health of patients first instead of the development of vaccines, vaccines which will not improve the health of patients currently suffering with these chronic bacterial infections!
The CDC is not ignorant of the problem of Lyme disease and other tick-borne
infections ravaging patients in this country today. The CDC has a responsibility
to take positive action, action which will be beneficial to LYME PATIENTS
instead of patent-holding, financial-interest-bearing individuals, some of whom have very close associations with the CDC. The
day has come for the CDC to begin acting in a manner which shows that they can
place the health of Lyme patients above the special interests of the elite group
of individuals they have been catering to for so many years!
I DO NOT accept the stance that the above-referenced instructions in Public Law
107-116 are
“recommendations,” and therefore, the CDC does not need to act upon those
instructions. The CDC has been encouraged to act upon information provided to
them regarding a devastating, debilitating disease, namely Lyme disease
(including co-infections), that is afflicting people in this nation. The agency
is called the Centers for Disease Control and Prevention. I believe that the CDC
is obligated to make sure that it lives up to its name for the sake of the
people of this nation who are entrusted in its care. The CDC’s perception of its
role in CONTROLLING this disease is evident in the way in which they are
CONTROLLING the laboratory testing criteria and the inadequate IDSA Treatment
Guidelines they support. The only PREVENTION is that of diagnosis and treatment. Having cases reported
to the CDC for epidemiological purposes isn’t enough when it comes to the issue
of the health of the nation! Failure to properly diagnose and provide treatment
to chronically-ill patients creates increased costs in long-term health care,
lost productivity and government assistance.
L.E.A.P. Arizona again calls upon the CDC to send an alert to ALL physicians. “The
Committee recommends that the CDC strongly support the re-examination and
broadening of the Lyme disease surveillance case definition by the Council of
State and Territorial Epidemiologists. Voluntary and patient groups should have
input into this process. Currently there is just one definition (“confirmed
case”) of seven possible categories. By developing other categories while
leaving the current category intact, the true number of cases being diagnosed
and treated will be more accurately counted, lending to improved public health
planning for finding solution to the infection” (emphasis added).
Please note that voluntary and patient groups should have input into this
process. Please consider this webpage as documented, pertinent patient input.
Also from the Committee Report:
“National Institutes of Health – Office of the Director Lyme Disease
The NIH is encouraged to include a broad range of scientific viewpoints in the
process of planning and executing these efforts, including community-based
clinicians with extensive experience in treating these patients, voluntary agencies who have advocacy in their mission, and patient
advocates.”
I challenge the NIH and CDC to work amiably with community-based clinicians with
extensive experience in Lyme disease treatment from ALL areas and groups, not
just patent-holding, financial-interest-bearing individuals. The CDC must utilize information
from ALL diagnostic
and treatment views to prevent bias against Lyme patients and to provide
Informed Consent by providing information about both STANDARDS OF CARE that
exist in Lyme disease treatment.
In addition, it is very distressing to read the study entitled “Inaccurate Information About Lyme Disease on the Internet",
which is posted on the CDC Lyme Disease homepage. The results
of this evaluation show that, among just a few others, only the CDC and FDA
websites contain accurate information on Lyme disease. It totally disregards
what Lyme disease patients and Lyme-experienced physicians are saying about Lyme
disease. This does NOT help the problem at hand.
This is a problem because many physicians refer to the CDC for information. What message is the CDC sending to physicians nationwide? They are setting up people afflicted with painful, debilitating Lyme and co-infections for failure in obtaining diagnosis and treatment. If a physician reads that “scientific” article and a patient who believes they have Lyme disease presents to the office with information from the Internet, the physician will automatically dismiss that information as invalid. What is the CDC really trying to prevent? To this Lyme disease patient and many others, it looks like they’re trying to prevent diagnosis and treatment.
If I had relied upon the CDC website for a list of symptoms and treatment
information when I was so extremely ill, I probably wouldn’t be
here today. Instead, I relied upon information from Dr. Joseph Burrascano's
Advanced Topics in Lyme Disease and info from the
International Lyme
and Associated Diseases Society (ILADS). The CDC should not flatter itself in presenting
to the public that it is the all-knowing expert when it comes to Lyme disease. The CDC has a
lot to glean from the Lyme-experienced physicians associated with ILADS, but
first it needs to stop catering to the small group of individuals who have been
and who are still controlling the diagnosis and treatment of Lyme disease
patients.
It appears
from the CDC’s stance that the agency is in the ring to fight, not as an ally,
but as a contender with chronic Lyme patients nationwide. As such,
and taking into account that there is growing number of people who have died
from complications related to chronic Borrelia infection, the CDC has blood on
its hands and should be held legally accountable.
The CDC could have approved accurate testing that was presented to them a long
time ago;
instead, they chose to stay with the two-tier testing approach which is known to
be inaccurate and unreliable. In addition, the CDC is complacent with issuing vaccine-oriented
diagnostic criteria to laboratories and state health departments which are of no
help to the millions suffering with chronic infections. They also provide
misleading information by posting
ludicrous studies of Internet websites, studies of which invalidate information
from patients and Lyme-experienced physicians and researchers.
It has been more than five years since Public Law 107-116 was signed by
President Bush. On behalf of all Lyme patients suffering from lack of or delayed
diagnosis and treatment, I publicly demand an accountability for detrimental actions taken
by the CDC and others, which will directly assist Lyme
patients in obtaining diagnosis and treatment.