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Will Pennsylvania Proposal Sanction Improper Treatment of Lyme Disease?

JUN 16, 2017 | AMESH A. ADALJA, MD, FIDSA
When it comes to Lyme disease, nothing is simple. This tick-borne bacterial infection, which exploded onto the scene in the 1970s, has grabbed headlines, sparked protests, prompted an anti-trust lawsuit, and become politicized to a degree that many infectious disease physicians believe is disproportionate to its nature.
 
Make no mistake, Lyme disease is a major infectious disease in the United States. In Pennsylvania, my home state, the number of annually reported cases leads the nation. I am constantly queried by patients, friends, and acquaintances regarding the infection.
 
The chief driver of the politicization is the existence of a subgroup of patients who contract Lyme and despite treatment with an appropriate course of antibiotics are left with a constellation of residual symptoms such as fatigue, malaise, headaches, and pain. These patients with post–Lyme disease syndrome are understandably frustrated with their symptoms and continue to seek treatment. Many of these patients—and a subset of physicians—believe their symptoms are the result of ongoing infection with the Lyme bacteria, although there is no evidence to support this case. Multiple studies have failed to demonstrate viable Lyme bacteria are present in these patients.1 There are some data, however, that immunological alterations may be present in some cases.2 With no active bacterial infection present, there is no role for further antibiotic treatment—another question answered by several trials that found no benefit to the practice.3-5
 
With several negative antibiotic trial results, no biological evidence for persistent infection, and clinical guidance from both the Infectious Diseases Society of America (IDSA)6 and the Centers for Disease Control and Prevention7 recommending against prolonged antibiotic treatment for these patients, there should be no controversy in this regard. However, that is far from the case, as a cottage industry has sprung up comprising physicians who “specialize” in offering these patients antibiotics and other unproven therapies that range from nutritional supplements to ozone and hyperbaric oxygen. Paradoxically, as if plucked from George Orwell’s 1984, these purveyors are known as Lyme-literate doctors despite their brazen evasion of the conclusions of all the peer-reviewed literature on the topic.
 
Given the scientific data, it is no surprise that insurance companies rightly and justifiably do not believe that paying for unproven and ineffective therapies is warranted, leaving patients who desire such therapies to foot the bill. All of this is about to change in Pennsylvania as a bill being considered in the state legislature seeks to force insurance companies to pay for such therapies—against the scientific and business judgement.
 
The Lyme Disease and Related Tick-Borne Illness Diagnosis and Treatment Act (Senate Bill 100), which was co-introduced by my own state senator Scott Hutchinson (R), was clearly inspired, influenced, and likely developed by “Lyme-literate” physicians. I think it is likely that not one board-certified or fellowship-trained infectious disease physician was consulted. As such, the act employs obfuscation and the standard talking points of this group, such as the bureaucratic and arbitrary removal of the current IDSA guidelines from the National Guideline Clearinghouse, solely because they were issued in 2006, to justify government overreach into the medical and insurance industries.
 
There are many legitimate and pressing scientific questions regarding Lyme disease and the Borellia burgdorferi bacterium that causes it. One of these questions revolves around understanding the cause of the symptoms that plague the unfortunate patients who this bill is purported to help. By legislative fiat, however, the bill would codify an unscientific treatment paradigm, encourage inappropriate antibiotic use, foment antibiotic resistance, and place more patients at risk of antibiotic side effects. Equally important is the fact that this bill, by sanctioning false treatment paradigms, will divert attention from understanding the true cause of these patients’ persistent symptoms and consequently delay the discovery of appropriate treatments—vitiating the bill’s stated purpose.
 
Dr. Adalja is a board-certified infectious disease physician who practices in Pittsburgh. He blogs on infectious disease issues at www.trackingzebra.com. His Twitter handle is @AmeshAA. 
 
References
  1. Bockenstedt LK, Radolj JD. Xenodiagnosis for posttreatment Lyme disease syndrome: resolving the conundrum or adding to it. Clin Infect Dis. 2014;58:946-948.
  2. Strle K, Stupica D, Drouine EE. Elevated levels of IL-23 in a subset of patients with post-Lyme disease symptoms following erythema migrans. Clin Infect Dis. 2014;58:372-380.
  3. Klempner MS, Hu LT, Evans J, et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001;345:85-92. 
  4. Fallon BA, Keilp JG, Corbera KM, et al. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology. 2008;70:992-1003. 
  5. Krupp LB, Hyman LG, Grimson R, et al. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology. 2003;60:1923-30.
  6. Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006;43:1089-134.
  7. Centers for Disease Control and Prevention. Why does CDC only link to one set of treatment guidelines? CDC website. https://www.cdc.gov/lyme/treatment/guidelines-explanation.html. Updated December 7, 2016. Accessed June 7, 2017.
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