Antibiotic maximalism: legislative assaults on the evidence-based treatment of Lyme disease.

• Author: Franklin, Joseph B.

INTRODUCTION

Antibiotics, and the deadly pathogens that have evolved to resist them, are one of the major public health concerns of our time. The introduction of penicillin in the early 1940s signaled a new era--not only for the treatment of devastating infections, (1) but also for the out-witting of antibiotics by fast-evolving bacteria. (2) If the middle of the twentieth century saw the era of antibiotic innovation, (3) the past several years might be labeled the era of antibiotic resistance, when untreatable infections have become a modern scourge. (4) Methicillin-resistant Staphylococcus aureus (MRSA) is the most notorious antibiotic resistant "superbug"; (5) this antibiotic-resistent pathogen has emerged as an endemic problem in hospital and long-term care settings. (6) In 2011, bills were introduced in both houses of Congress (7) to encourage the development of new antibiotics to replace those that have become ineffective. (8) Yet, unless or until a truly "miracle" antibiotic (i.e., one which may not be resisted by bacteria) is someday developed, the only solution to antibiotic resistance is to reduce the use of antibiotics. (9)

Surprisingly, amidst public-health efforts to prevent antibiotic-resistant pathogens by reining in excessive antibiotic use, (10) several states have passed laws that legitimize intensive antibiotic regimens even when those regimens contradict the best available medical evidence. (11) Although this unprecedented legislative activity has occurred in the context of a controversial medical diagnosis, chronic Lyme disease, the legal and political repercussions threaten the established role of state medical licensing boards in promoting evidence-based standardization of medical practice. The most intrusive of these statutes (12) prevents state licensing boards from disciplining physicians who prescribe regimens of long-term antibiotic therapy that are specifically proscribed by mainstream clinical practice guidelines (CPGs) on Lyme disease treatment. (13) Such laws promote the view of non-standard practitioners (14) who favor the intensive, maximalist (15) use of antibiotics for a condition that mainstream physicians dispute even exists. (16) In an attempt to protect unnecessary antibiotic regimens, recent legislation legitimizes a treatment paradigm that poses an undue risk of harm to individual patients (17) and to the public health. (18)

By enacting laws that protect and legitimize repudiated treatments, state legislatures have responded to a movement of non-standard "Lyme literate medical doctors" (LLMDs) (19)--a movement that has been described as an "antiscience" and "parallel universe of pseudoscientific practitioners" by mainstream practitioners. (20) In addition, by interfering with the legal authority of state medical boards to enforce evidence-based standards on antibiotic use, states have also sided with a fringe movement of physicians (21) who oppose the "encroachment" of third-parties, (22) including the government, upon the physician-patient relationship. (23) These advocates decry the influence of evidence-based clinical guidelines and state medical licensing boards on the medical practice. (24) Removing the power of state regulators to discipline physicians for dangerous, nonstandard Lyme disease treatment is perceived as an opening salvo in the attack on the legitimacy of state medical oversight. (25) infra Part I.B.3.

Part I of this Note describes clinical practice guidelines generally, including their legal implications, before describing the conflict between two competing Lyme disease treatment guidelines. Part II examines the political and legal debates that have led to state discipline-preemption statutes. Part III analyzes how new state laws in this area (hereinafter LLMD-protection laws) promote the maximalist use of antibiotics championed by non-standard practitioners. Part IV is a discussion of the ramifications of LLMD-protection laws. Though such legislation has mostly been limited to the geographic regions most affected by Lyme disease, (26) similar laws have been advocated in other states (27) as nonstandard Lyme disease practice becomes a nationwide phenomenon. (28) These statutes demonstrate the irrational policies that may result from the politicization of medical science. By repudiating evidence-based clinical practice guidelines, states have put patients at risk of receiving dangerous and unnecessary treatment. Furthermore, by precluding state regulators from disciplining certain maximalist uses of antibiotics, LLMD-protection laws undermine a potentially important tool in the fight against antibiotic resistance. Part V offers a few concluding remarks.

1. CLINICAL PRACTICE GUIDELINES AND THE CONTROVERSY OVER LYME DISEASE TREATMENT

   Before proceeding, it is important to acknowledge that neither the legal nor the scientific discussions of Lyme disease are grounded in absolutes. Clinical practice guidelines (CPGs) are not definitive statements of the standard of care required of physicians, but rather voluntary recommendations that are, ideally, based in the best-available evidence. (29) Meanwhile, state medical licensing statutes provide that physicians may be disciplined for vaguely defined offenses such as "unprofessional conduct." (30) And, as in any medical field, our scientific understanding of Lyme disease will continue to evolve.

   Nevertheless, statutes that legitimize diagnoses and treatments that are repudiated by evidence-based medical guidelines challenge the assumption that evidence-based medicine can withstand the pressures of the democratic process. This is a significant revelation, as evidence-based medicine is a cornerstone of modern proposals to reform the healthcare system. (31)

   The political and legal controversies surrounding Lyme disease treatment are rooted in an intraprofessional disagreement between mainstream and non-standard clinicians over the proper use of antibiotics to treat Lyme disease. In no small part, this disagreement is a product of a movement among some physicians and their patients who, for a variety of reasons, resist the modern drive toward standardization in medical practice, particularly by CPGs. (32) This Part first provides an overview of CPGs and their legal significance. Next, this Part examines two conflicting CPGs for Lyme disease treatment, from the mainstream and non-standard physician communities, respectively. Though it is a simplification to portray the Lyme treatment controversy as a binary one, the competing Lyme disease CPGs have become a significant point of contention among advocates and politicians in states that have passed legislation favoring non-standard practitioners.

   1. Clinical Practice Guidelines Generally

      Standardization of medical practice has been a goal throughout the modern era, aimed at ameliorating variability in medical practice. (33) A key vehicle for standardization in modern practice is the CPG, (34) which is designed to summarize the best available evidence and recommend courses of action to practicing physicians. (35) Modern CPGs, such as the IDSA Guidelines on Lyme disease treatment, (36) are "consensus statements" of the appropriate therapy or medical response to a particular set of symptoms. (37) Intended to summarize the best available evidence for the clinician, CPGs provide "an evaluation of the quality of the relevant scientific literature and an assessment of the likely benefits and harms of a particular treatment." (38) CPGs are developed by a diverse array of parties, including professional medical societies, health insurance companies, and the government. (39) CPGs promulgated by professional societies, in particular, "are regarded as highly authoritative." (40)

      CPGs are voluntary by nature. (41) In general, the real effect of CPGs on physician behavior has been questioned by some commentators. (42) The application of CPGs by certain third parties, however, may bolster the impact of CPGs on clinical decision-making. In particular, CPGs may be used (1) by health insurers (to determine whether a therapy will be reimbursed by health insurance); (43) (2) by the courts, as evidence of the "standard of care" (applied to physicians in malpractice suits and to health insurers when a plaintiff challenges a denial of insurance coverage); (44) and (3) by state licensing boards when they enforce professional standards prescribed by statute. (45)

      First, the most important impact of CPGs may be on the reimbursement policies of health insurers. When health insurers or managed-care providers use guidelines to decide whether to reimburse patients for a particular intervention, such decisions undoubtedly affect clinical practice. (46) The controversy over Lyme disease itself reflects the impact of CPGs on insurance reimbursements. As is explored in more detail, infra, the perceived impact of CPGs on insurance reimbursement decisions (47) has fueled legal and political action against the authors of the mainstream Lyme disease CPG, who have been accused of colluding with insurance companies. (48)

      Second, CPGs may impact medical decision-making when they are used to establish the legal standard of care, either in the physician malpractice or insurance coverage setting. The status of CPGs as evidence in malpractice and insurance coverage cases is still evolving. (49) Several considerations suggest that a CPG alone will be unlikely to provide the standard of care applied in a malpractice trial. For a court to apply a CPG directly to the legal standard would likely require legislation, as it would depart substantially from the traditional standard based in professional custom. (50) However, CPGs may be used indirectly to establish professional standards; guidelines may be the basis of expert testimony establishing "what the relevant custom is in a particular set of circumstances" (i.e. the legal standard for malpractice). (51)

      Commentators have argued against the use of...