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Lyme Disease: Two Standards of Care

By Lorraine Johnson, JD, MBA
Executive Director, CALDA

Lyme disease: Lyme disease, which is caused by the bacterial spirochete Borrelia burgdorferi, is a public health threat of major proportions. The majority of Lyme disease cases result from bites by infected nymphal ticks that may be as small as the period at the end of this sentence.[1] Only 14-35% of patients recall a tick bite.[2] In addition to transmission of Lyme disease by ticks, some studies have a) provided evidence of gestational transmission, b)suggested transmission by other insects and blood transfusions, and c) hypothesized transmission by intimate human contact[1, 3-6]

Coinfections: Ticks have been called "sewers of infection." They feed primarily on birds, rodents, and deer and can transmit to humans many of the diseases carried by these animals. Hence, patients with Lyme disease may be infected with multiple pathogens. The most widely known co-infections acquired from ticks are babesia, bartonella, ehrlichia and Mycoplasma fermentans.[7] Not all pathogens have been identified.[8-10] Patients with coinfections may have more severe symptoms and an extended course of illness.[11]

Prevalence According to the Centers for Disease Control and Prevention (CDC), only one in ten cases of Lyme disease which meet the CDC surveillance criteria is reported, which means that the 23,763 cases national reported in 2002 reflect 237,630 actual cases which meet the CDC criteria.[1] The annual incidence of Lyme disease, which accounts for 95% of vector-borne illnesses in the United States, has increased almost 50-fold since the national surveillance began in 1982.[1, 12] In 2002, Lyme disease increased 40% over the prior year.[13] Lyme disease is hyperendemic along the East Coast, in the upper Midwest, and on the Pacific coast.[12] Lyme infected ticks may be transported from Lyme-endemic areas into non-endemic areas along the "flyways" of migratory birds.[14] Children under 15 years of age account for 25% of reported cases.[1] Many children with Lyme disease experience a dramatic drop in IQ, a decline in grade point average, and require home instruction.

Common Symptoms: Lyme disease is a complex, multi-system disease that has now been shown to involve nearly every organ and organ system in both sexes.[15] The most common symptoms in patients with early Lyme are fatigue, arthralgia , fever or chills; stiff neck and anorexia.[16] Erythema migrans, the characteristic rash that is an initial indicator of Lyme disease, is present in fewer than 50% of Lyme disease patients.[17, 18] Other common symptoms include headache, shortness of breath, cognitive impairment, and mood disorders.

Disease Progression: If it is not detected and treated early on, Lyme disease may involve the central nervous system, mimicking diseases such as multiple sclerosis (MS), neurosyphilis, meningitis, brain tumor, Alzheimer's disease, Parkinson's disease, amyotropic lateral sclerosis (ALS), autism, or psychiatric illness.[19, 20] Untreated or inadequately treated Lyme disease patients become increasingly disabled over time[21]. Patients with persistent Lyme disease suffer physical disability equivalent to that of congestive heart failure.[22] Although it is commonly believed that Lyme disease does not result in death, at least 22 research studies have documented deaths associated with Lyme disease.[18, 20, 23, 24]

Clinical Diagnosis: Because Lyme disease mimics so many other conditions, it can be difficult to diagnose. The average patient with persistent Lyme disease sees five doctors over a 21-month period to obtain an accurate diagnosis.[18] Lab tests should never be the primary basis for making a Lyme disease diagnosis. Because the commercially available lab tests used to diagnose Lyme disease are flawed, the CDC, FDA and NIAID have all stressed that Lyme disease is a clinical diagnosis (based primarily on clinical presentation and supportive history, such as exposure to environments where ticks occur) and cautioned against over-reliance on lab tests.[1, 25, 26]. The two most commonly used lab tests, the ELISA and Western blot, miss between 20-50% of patients with Lyme disease. ELISA tests miss roughly 50% of those with Lyme disease.[27] Although the Western blot is recognized by the NIAID as the most useful antibody test currently available for Lyme disease[28], it may miss 20-30% of the cases that are seronegative.[29-31] However, many insurers and HMOs deny treatment and reimbursement to patients with negative tests regardless of the clinical diagnosis.

Misuse of CDC Surveillance Definition for Diagnosis and Insurance Reimbursement. According to the CDC, surveillance case definitions are created for the purpose of standardization, not patient care[32] This is because physicians should appropriately err on the side of over-diagnosis (so they do not miss a case), while surveillance case definitions appropriately err on the side of specificity, (so they do not inadvertently capture other illnesses).[32] For purposes of surveillance only, the CDC has adopted a restricted definition of Lyme disease which includes two-tiered testing (positive ELISA followed by positive Western blot) and a narrow definition of antibody bands necessary for a positive Western blot. As noted above, the ELISA alone misses approximately 50% of confirmed Lyme cases and combining it with a Western blot that misses 20-30% of confirmed Lyme cases is a recipe for disaster in terms of diagnosis and treatment. Preliminary results on a CALDA survey indicate that more than 50% of patients with persistent Lyme disease were initially misdiagnosed for an average of 3.18 years due to misuse of the CDC surveillance criteria. According to the CDC, surveillance criteria should not be used as the sole criteria to establish a clinical diagnosis, the appropriate standard of care, or insurance reimbursement.[33] However, many HMOs and insurers misuse the CDC surveillance case definition and apply it to diagnostic and insurance reimbursement determinations.

Treatment: The central difficulties in the diagnosis and treatment of Lyme disease stem from the lack of sufficiently sensitive and reliable biological markers of the disease. Without such markers, it is difficult to determine who has the disease, the effectiveness of a course of treatment, and the end point of treatment. When diagnosed and treated early, antibiotic treatment for 3-4 weeks may be effective.[34] IV antibiotics are indicated where there is meningitis, carditis, later-stage neurologic Lyme disease, and complicated Lyme disease arthritis.[1]

Treatment of Persistent Lyme disease: Patients who are not diagnosed and treated promptly are more difficult to treat. No single antibiotic or combination of antibiotics completely eradicates the infection which may include coinfections; and treatment failures or relapses (ranging from 24-50%) are reported with all short term treatment regimens.[35-37]. Two schools of thought regarding treatment of these patients exist. Some terminate treatment after 30 days unless objective evidence of continued infection can be demonstrated on the theory that the on-going symptoms reflect an autoimmune condition, while others, recognizing the shortcomings of the currently available lab tests, continue treatment until the patient's symptoms resolve. Where treatment options exist, physicians are required to discuss material options with the patient (regardless of their cost or the extent to which the treatment options are covered by health insurance).[38, 39] Treatment choice involve trade-offs between the risks and benefits of the different treatment alternatives that only patients--who know the kinds of risks they are willing to run and the types of quality of life outcomes that matter to them--are uniquely suited to make. However, many HMOs and insurers have adopted the short- term treatment protocols and deny treatment and insurance reimbursement to those who remain ill.

For further information, please visit the national Lyme Disease Association's (LDA) website at www.LymeDiseaseAssociation.org. The president of the LDA can be reached at Lymeliter@aol.com.


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