PROBLEMS STATEMENT
Lyme disease and other tick-borne illnesses are bacterial and/or parasitic infections that cause a wide array of symptoms which, if viewed separately, may mimic other conditions, making diagnosis difficult. However, diagnosis is not difficult when it is made clinically by taking adequate time to gather a patient’s history and by listening attentively to all of the diverse physical, mental and emotional symptoms/complaints associated with tick-borne illnesses.
Reliance upon serological testing alone for diagnosis of Lyme disease is a dangerous and risky approach which is preventing many infected patients from receiving proper diagnoses. This results in either treatment of very short duration or in most cases ABSOLUTELY NO TREATMENT AT ALL for extended periods of time, sometimes years. This unconscionable delay in diagnosis and treatment allows the bacteria to continue replicating inside various systems of the patient’s body causing neurological, cognitive, musculoskeletal and sometimes cardiac abnormalities.
The study of co-infections and Borrelia burgdorferi, the bacteria which causes Lyme disease, is a progressive field with new research emerging yearly. In addition, there is research dating back to the 1990's that showed that chronic Lyme disease is caused from persistence of infection. It is requisite that government agencies, physicians, laboratories and insurance companies keep abreast of the most current research and treatment protocols and read the previous research that has already proven that short courses of antibiotics do not always eradicate the spirochete. let alone the cell-wall deficient forms of the bacterium.
A common misconception of the majority of physicians in Arizona is that, because no cases of Lyme disease have been reported as having originated in the State of Arizona, that a person cannot get bitten by a tick and contract the disease in Arizona. When questioned about this misconception, some physicians defer to the Arizona Department of Health Services as their source of information. Some patients in Arizona have contracted the disease here; however, if their physicians do not diagnose them their cases will NEVER be reported. Thus, the cycle continues.
Many patients have contracted the infections in other states or from a source other than a tick bite; these patients are also unable to obtain appropriate treatment from the majority of physicians in Arizona. This problem, along with a web of other issues, makes clear the need to promote education and awareness in government agencies, the medical community, laboratories, insurance companies and the public.
The Centers for Disease Control and Prevention (CDC) has made it clear to state and county health departments that their epidemiological case criteria is for reporting purposes ONLY and is not to be used as a guide for clinical diagnosis. However, at the same time, the CDC played a role in establishing laboratory testing criteria based upon their epidemiological five-band criteria. This means that patients with two, three or four highly-specific bands of the Borrelia burgdorferi bacteria are being discounted as negative and are unable to receive diagnosis and treatment recommendations from their physicians. To say in one breath that epidemiology criteria should not be used for diagnosing Lyme disease and then to allow diagnostic laboratory test kits that use the CDC's epidemiology criteria to be marketed and used for diagnosis is MORE THAN AN OVERSIGHT! This problem has been brought to the attention of the CDC for years, yet the CDC deliberately fails to correct it and continues to ignore the thousands of people suffering due to reliance on these particular epidemiology-based laboratory test kits!
Thousands of patients with Lyme disease and co-infections are being denied proper diagnosis and treatment due to laboratory criteria implemented at the Second National Conference on Serologic Diagnosis of Lyme Disease held in Dearborn, Michigan in 1994. This criteria was determined prior to the Lymerix vaccine clinical trials, and the developers of the Lymerix vaccine had a hand in the implementation of the clinical trial-friendly laboratory criteria. Again, in this instance, the CDC, our government agency vested with authority for the control and prevention of diseases, fails to advise the public that there were many adverse reactions from the Lymerix vaccine that resulted in litigation. Instead, they inform the public that the Lymerix vaccine was pulled from the market due to poor sales.
There is better testing available through tick-borne disease testing labs that utilizes 16 bands as compared to the 10 bands used in the epidemiology-based tests. To date, no revisions in the testing criteria have been made by the CDC or the individuals who own patents on the epidemiology-based test kits utilized by labs like Qwest Diagnostics.
Unfortunately, when positive test results from specialized tick-borne disease labs are presented to most physicians, these physicians refuse to accept the positive results unless there are five reactive bands (per the Dearborn/CDC epidemiologic criteria). This is contrary to MMWR directions to physicians that their epidemiology criteria should not be used for diagnostic purposes. Patients are forced to pay for their own tick-borne disease laboratory tests, and because most physicians refuse to validate those tests, patients must seek treatment from Lyme-literate physicians and pay for it themselves. This is an extreme hardship for patients who are so ill that they are unable to remain employed.
It is the position of L.E.A.P. Arizona that the serologic diagnostic criteria implemented at the Second National Conference on Serologic Diagnosis of Lyme Disease held in Dearborn, Michigan in 1994 is based upon a vaccine that is NO LONGER ON THE MARKET. It is a “business model” criterion that favors vaccine developers and Lyme test kit patent owners instead of patients. We publicly call upon the entities involved with implementing that criteria, namely, the Association of State and Territorial Public Health Laboratory Directors, the Centers for Disease Control and Prevention, 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, to revise this criteria IMMEDIATELY, by adding back to the diagnostic criteria the bands that were omitted to accommodate the vaccine which was subsequently pulled from the market and vaccines currently being developed. The highly-specific bands that were omitted are the OspA (31 Kda) and OspB (34Kda).
We believe that those highly-specific bands should still be utilized in the serologic criteria, as they were prior to the Lymerix vaccine being approved and then pulled from the market. In addition, the five-or-more-reactive-band laboratory criteria should be changed so as not to reflect the CDC epidemiologic criteria, which is to be utilized only for tracking cases not for diagnosing them.
We publicly state that the Centers for Disease Control and Prevention should take seriously any and all “recommendations” set forth in Public Law 107-116 signed by President Bush on January 10, 2002, and any and all subsequent legislation passed, by acting upon those “recommendations” and not ignoring their responsibility in educating state health departments, the medical community and the public (including insurance companies) of the TWO STANDARDS OF CARE that have been established by treating physicians across the United States.
Many patients are denied diagnosis and treatment by physicians on their health plans, and consequently, the health plans deny treatment altogether. This is a crime against a large and growing group of patients in Arizona and nationwide. This causes patients needless pain and suffering physically, emotionally and financially for extended periods of time. It also ultimately increases the cost of these infections by increasing long-term health care costs, lost productivity and increased costs in government assistance.
Insurance companies are basing their coverage benefits for Lyme disease treatment upon the Guidelines authored by the Infectious Diseases Society of America (IDSA). The IDSA Guidelines recommend absurdly short courses of antibiotics for Borrelia burgdorferi (Bb), the bacterium that causes Lyme disease, despite the fact that research from the CDC has proven that Bb SEQUESTERS ITSELF INSIDE OF NERVE CELLS AND EVADES THE IMMUNE SYSTEM!
What is even more problematic is that the IDSA Guidelines DO NOT acknowledge the existence of chronic infection. They instead refer to to it as "Post Lyme Syndrome," some vague condition of unknown etiology. The IDSA claims to be science-based organization. Unfortunately, they are blatantly ignoring published research conducted by their own IDSA Lyme Disease Treatment Guideline authors, such as Allen C. Steere and Raymond J. Dattwyler, in which they say that short courses of antibiotics fail to eradicate Borrelia burgdorferi. The CDC posts only the IDSA guidelines on their Lyme disease website, despite the fact that their own researchers, Jill A. Livengood and Robert C. Gilmore, Jr. published the research referred to in the previous paragraph.
IMPORTANT NOTE: In November of 2006, Connecticut Attorney General Richard Blumenthal began a Civil Investigative Demand of the IDSA for possible antitrust violations in the formulation of their Lyme disease Treatment Guidelines. The final determination has not yet been made as of this writing. (June 18, 2007)
In Arizona, we have several species of ticks feeding off hosts such as deer, rabbits, mice, lizards and birds. Not all ticks carry the Lyme disease bacteria and co-infections and not every tick is infected. However, there are several species of ticks in Arizona, not just the Ixodes pacificus (Western blacklegged tick), that are possible carriers of a variety of infections, such as Babesiosis, Erlichiosis, Relapsing Fever, Tularemia and Rocky Mountain Spotted Fever. In addition, it is now thought that bird migration, mosquitos, fleas, gnats and mites may be playing a role in the spread of these infections throughout our country. Borrelia burgdorferi has been isolated in male and female body fluids, tears and breast milk. Although transmission via intimate contact, in utero or nursing has not actually been proven, it is common sense that these modes of transmission may exist.
If our government agencies fail to utilize research funds to prove the existence of these modes of transmission, the seriousness of this spreading infection will continue to be downplayed. In addition, the Borrelia burgdorferi bacterium has survived while frozen in the national blood supply, and the blood supply is not tested for this devastating bacterium. Is it not common sense that the infection could be transmitted via blood transfusion?
It is the position of L.E.A.P. Arizona that a concerted effort by all entities and parties involved with this dilemma needs to be implemented. We publicly urge The Centers for Disease Control and Prevention, the National Institutes of Health, the Arizona Department of Health Services, all physicians, laboratories, insurance companies, other health care providers and the public to take responsibility for ensuring that patients suffering from Lyme disease and co-infections are treated with respect and courtesy by validating the patients’ symptoms/complaints and by the entities repositioning themselves in a more open-minded stance with regard to diagnosis and treatment protocols.
It is wrong for doctors to turn away patients who may be infected with this biowarfare agent, Borrelia burgdorferi. It is the position of L.E.A.P. Arizona that physicians have the responsibility to abide by the Hippocratic Oath they took by making every attempt to correctly diagnose tick-borne illnesses in their patients. This is an emerging infectious disease of epidemic proportions in this country and infected patients are not receiving the antibiotics that they need.
There are currently TWO evidence-based, peer-reviewed, published Treatment Guidelines, one from The International Lyme and Associated Diseases Society (ILADS at www.ilads.org) and the other from the Infectious Diseases Society of America (IDSA at www.idsociety.org). As mentioned before, the IDSA Guidelines are currently under investigation by the Connecticut Attorney General’s Office for possible antitrust violations.
However, mainstream physicians, government agencies and insurance companies are only utilizing the IDSA Guidelines which recommend short-term therapy and deny the existence of chronic infection. L.E.A.P. Arizona urges the entities above to take responsibility by acting upon the most current information available and initiating an educational campaign which encompasses BOTH evidence-based, peer-reviewed, published Treatment Guidelines.
This is called INFORMED CONSENT.
L.E.A.P. Arizona will amicably assist and work with any of the entities above to carry out this goal.
We have been complacent while patients are suffering without diagnoses and treatment; let us resolve to be complacent no longer.