MAY 24, 2017 | PAT SMITH
Is the Medical Community Behind the Times When It Comes to Treating Lyme?
Many physicians solely rely on the two-tiered indirect Lyme tests recommended by the CDC and the outdated guidelines.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,5 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.
Additionally, there is no test for active Lyme disease infection, and test interpretation, especially the use of specific bands in the WB (IgM 2/3; IgG 5/10), developed at the 1994 CDC/Association of State and Territorial Public Health Laboratory Directors Dearborn meeting,6 is problematic. Some doctors and researchers believe those bands were selected only to protect the then-in-development Lyme disease vaccine (subsequently licensed and withdrawn over 4 years). Furthermore, the Lyme ELISA used for screening may not react with serum antibodies if at least a month has not elapsed between the tick bite and the test. If antibodies do develop, research in the Journal of the American Medical Association7 has shown that the antigen and the antibody produced by the patient can form a complex. Current commercial tests can only test for a free antibody, not an antibody in a complex, so patients can remain undiagnosed despite having produced antibodies.
Perhaps most noteworthy is that FDA-cleared commercial serological tests are based on one strain of Borrelia burgdorferi bacteria in contrast, for example, to a 2-strain Lyme test developed by one independent Clinical Laboratory Improvement Amendments-approved lab. The recent discovery by Mayo Clinic/CDC of the Borrelia mayonii species in the Midwest, which can also cause Lyme, and the acknowledgement that Borrelia miyamotoi, a spirochete closely related to the relapsing fever bacteria and more distantly related to the Lyme bacteria, causes a Lyme-like disease in the United States, means Ixodes scapularis ticks transmit all three of those bacteria, further clouding the diagnostic picture.
There has been considerable research over the past several years supporting the existence of chronic Lyme, including the discovery at Northeastern University that persister cells are formed by B. burgdorferi.8 These cells go dormant when treated with antibiotics, but can grow again after treatment stops. Persisters are found in other diseases as well. Work at Johns Hopkins has also been done on persisters: research in Emerging Microbes & Infections,9 “…identified 165 agents approved for use in other disease conditions that had more activity than doxycycline and amoxicillin against B. burgdorferi persisters. The top 27 drug candidates from the 165 hits were confirmed to have higher persister activity than the current frontline antibiotics.” Additionally, work on biofilms in Lyme, by researchers from the University of New Haven, and published in European Journal of Microbiology & Immunology,10 demonstrated for the first time “…the presence of Borrelia biofilm in human infected skin tissue.”
The results of several animal studies have shown that the Lyme spirochete survives antibiotic treatment for Lyme disease, including a University of California mouse study,11 a Tulane monkey study,12 a Cornell dog study,13 and a National Institutes of Health human xenodiagnosis study.14
As new research continues to unlock persistence mechanisms used by B. burgdorferi, the medical community needs to avail itself of those scientific findings by attending continuing medical education conferences and grand rounds and partaking in preceptorships that foster divergent views. The medical community needs to support further research on why some individuals remain sick. It is imperative that healthcare professionals learn how to change that outcome rather than relying on outdated methodologies that have not benefited patient health.