Lyme disease has been recognized in the United States for more than 40 years, with about 400,000 new cases occurring in 2015, according to the Centers for Disease Control and Prevention (CDC). Nineteen tick-borne diseases now affect Americans, and one tick bite can cause more than one disease. A recent CDC study uncovered that ticks that cause Lyme disease are found in 50% of continental US counties.1
In addition, according to the results of a large Johns Hopkins University study, as many as 36% to 63% of patients with Lyme disease go on to develop chronic symptoms (posttreatment Lyme disease).2
Major problems surrounding Lyme disease today include reliance upon dogma, promoting beliefs people are expected to accept without questioning or doubting, and the use of selective science by many in the medical community, the Lyme “experts,” who often blame the patient, the internet, and treating doctors with divergent opinions for their own lack of successful patient outcomes. They continue to approach Lyme with a “cookbook” approach. Patients are told the symptoms are “in their head,” that they need to stop reading the internet, or parents of patients are accused of Munchhausen by proxy syndrome (ie, making their children sick). These experts neither want to understand why their approach does not work, nor do they want to take the necessary time to understand the disease by researching and reading all the science, not just that which supports their unsuccessful treatment approach. Steeped in dogma, they ignore the fact that Lyme is meant to be a clinical diagnosis using testing as an adjunct.
Lyme clinical practice guidelines (CPGs) (eg, Infectious Diseases Society of America [IDSA] guidelines) often used by these physicians to treat Lyme are outdated and not posted on the National Guidelines Clearinghouse (NGC) These guidelines are most often used to deny treatment to patients with chronic disease, and so their current absence from the NGC is beneficial to patients who may need long-term antibiotic therapy and have been denied this through use of these guidelines. The only Lyme CPGs available on the NGC are those adhering to newly revised National Academy of Medicine, formerly Institute of Medicine, standards for guidelines− the International Lyme and Associated Diseases Society (ILADS) Lyme Guidelines,3
which address the usefulness of antibiotic prophylaxis for tick bites, the effectiveness of erythema migrans (EM) treatment, and antibiotics’ role in retreatment of persistent Lyme disease symptoms.
Many physicians solely rely on the two-tiered indirect Lyme tests recommended by the CDC and the outdated guidelines. These recommendations include a positive/equivocal enzyme-linked immunosorbent assay (ELISA) followed by western blot (WB), and the tests that are US Food and Drug Administration (FDA)-cleared (substantially equivalent to a predicate test),4
yet not necessarily approved. To date, the FDA has not been able to provide Lyme Disease Association, Inc., with any information on any FDA-approved test for Lyme, including the original predicate test. According to research in BMJ
the two-tiered system, although very specific for Lyme disease (99%)—yielding few false-positives—has a uniformly low sensitivity (56%), missing 88 of 200 patients with Lyme. The current archaic Lyme tests remain unreliable decades later. By comparison, AIDS tests have a sensitivity of 99.5%, missing only one of 200 infected patients.