American Journal of Law & Medicine

Cure Unwanted? Exploring the Chronic Lyme Disease Controversy and Why Conflicts of Interest in Practice Guidelines May Be Guiding Us Down the Wrong Path

"We can't treat conflicts of interest like some family secret no one talks about. We must become more comfortable asking and answering pertinent questions about the sources and substance of industry funding that might influence individuals, institutions, and organizations." (1)


In 2006, the Infectious Diseases Society of America (IDSA) published practice guidelines for the assessment, treatment, and prevention of Lyme disease. (2) The guidelines purported to refute the existence of "chronic Lyme disease," (3) a condition that some believe results from persistent Lyme infection even after standard courses of antibiotic treatment. (4) The guidelines, which garnered national attention, (5) were in turn used by physicians and insurers alike as a justification for refusing treatment for chronic Lyme disease. (6) Two years after the IDSA published its guidelines, Richard Blumenthal, the Connecticut Attorney General, ordered an investigation into potential conflicts of interest on the part of the panelists who developed the IDSA's Lyme disease practice guidelines. (7) The findings of the investigation were deeply troubling.

Patients and physicians were startled to learn of the pervasive conflicts of interest that came to play in the promulgation of the IDSA guidelines regarding chronic Lyme disease. As Pamela Weintraub noted in her book, Cure Unknown, the very people who wrote the IDSA guidelines were those who stood to profit from them. (8) The authors of the guidelines not only had significant connections to drug companies, related patents, and Lyme diagnostic tests, several were also being paid by insurance companies to corroborate treatment plans that denied treatment for chronic Lyme disease. (9) With so many players from the IDSA standing to gain from the group's narrow definition of Lyme disease, it might not have been the case that a potential cure for chronic Lyme disease was unknown--it may have been unwanted.

Practice guidelines, such as those developed by the IDSA, are omnipresent in the healthcare industry. Developed by both public and private sector groups, guidelines are used to achieve many goals, such as standardization of practice, reduction of malpractice claims, and cost savings. (10) These guidelines are often created by panels of experts and can have significant effects on healthcare, particularly when used by insurance companies. (11) While practice guidelines can provide benefits to the medical community, the process of developing guidelines can be riddled with problems that detract from the guidelines' potential value. Conflict of interest issues, in particular, have come to the forefront of discussions about practice guidelines.

The healthcare industry comprises many overlapping parts: physicians, research institutions, drug companies, and medical device manufacturers are just a few of the industry's main players. Because of the pervasive connections that exist between all these actors, it can be difficult to achieve independent and unbiased opinions on medical issues. Often, practice guidelines reflect the industry's interwoven relationships rather than the best available medical knowledge. This is an especially problematic reality in the healthcare industry where information asymmetries rule the day. (12) Healthcare is structured around agency relationships, particularly the relationship that exists between healthcare providers and patients. (13) Healthcare providers have highly specialized knowledge that most patients lack. As a result, most patients are ill-equipped to navigate their way through the healthcare system. (14) As a result of this lack of patient knowledge, healthcare providers have most of the control over patients' decisions. (15) While patients may want to believe that healthcare providers always have their best interests at heart, conflicts of interest can make this an unrealistic expectation. Because practice guidelines often take on the force of law and increasingly represent biased and undisclosed relationships in the medical community, rules against conflicts of interest should be put in place to protect healthcare consumers.

Part II of this Note provides an introduction to the chronic Lyme disease controversy. Part III provides general information on practice guidelines. Part IV examines conflicts of interest in practice guidelines generally as well as the conflicts of interest that came to light under the Connecticut Attorney General's investigation into the IDSA's Lyme disease guidelines. Part V examines recent developments in the legal framework in place for managing conflicts of interest in practice guidelines. Finally, Part VI concludes that further reform is needed in order to prevent conflicts of interest from adversely affecting the use of practice guidelines.


Transmitted to humans by the bite of an infected blacklegged tick, (16) Lyme disease is one of the fastest growing infectious diseases in the United States. (17) Once infected, patients typically experience a wide range of symptoms, including fever, headache, fatigue, and skin rash. (18) In the event that the infection goes untreated, the disease may spread to the joints, heart, and the nervous system. (19) Certain groups in the healthcare industry, including the Centers for Disease Control (CDC) and the IDSA, believe that Lyme disease can always be effectively treated and eradicated with fourteen to twenty-eight days of antibiotics. (20)

However, other groups believe that this short treatment can be inadequate if the infection is not caught early. These groups believe that if left untreated, Lyme disease can develop into "chronic Lyme disease"--a persistent infection that can cause near-crippling exhaustion, nerve pain, memory loss, confusion, and dementia. (21) In such circumstances, treatment for fourteen to twenty-eight days, as recommended by the IDSA, is simply not long enough to eradicate the disease. (22) Rather, chronic Lyme supporters insist that the infection can require much longer treatment. (23) For their part, the IDSA and the CDC believe that chronic Lyme disease does not exist. These groups contend that any symptoms that remain after treatment are simply remnants of a treated infection that will eventually disperse. (24) Disagreement over chronic Lyme disease and whether it exists has been fierce and contentious.

The battle over chronic Lyme disease had been raging for more than thirty years when the IDSA released its guidelines for treatment in 2006. The origins of the disagreement and, more importantly, the conflicts of interest that are so prevalent in the Lyme community can be traced back to the initial description and definition of the disease in the Northeastern United States by Yale University-affiliated rheumatologist, Allen Steere. (25) In the early 1970s, the Connecticut Department of Health became concerned about the prevalence of what appeared to be junior rheumatoid arthritis (JRA) in a number of young adults living in the same town in Connecticut. (26) JRA, a disease of which clinical prevalence is one to ten per 100,000 people, had been identified in thirty-seven patients, several of whom lived on the same street. (27) At the behest of Connecticut residents and physicians, the Connecticut Department of Health encouraged Steere to look into the matter and identify the problem. (28)

Steere first identified what later became known as Lyme disease in 1977. (29) Although earlier European research had documented a disease with similar characteristics, Steere believed that Lyme disease was the result of a viral infection, unlike its alleged European counterpart, which was bacterial. His reasons for this conclusion were twofold. Steere's own studies had failed to show that all symptoms were eradicated after a very short course of antibiotics, which would have been standard treatment for a bacterial infection. Additionally, due to the fact that several of Lyme's symptoms were not identified in the earlier European research, Steere believed that he was dealing with a different infection entirely. (30) Because Steere believed that the disease was not bacterial, he declined to treat patients with antibiotics and instead offered aspirin and steroids to treat his patients' symptoms. (31) Steere eventually characterized Lyme as an infection that targeted the joints and could result in neurological or cardiac abnormalities. (32)

Steere's hypothesis of Lyme as a viral infection was finally proved false in the 1980s when Willy Burgdorfer discovered the bacteria Borrelia burgdorferi (later named in his honor) responsible for causing Lyme disease. (33) The discovery, of course, meant that Steere's refusal to treat patients with antibiotics no longer made sense. (34) In 1983, Steere released new data in the July issue of the Annals of Internal Medicine recommending a short ten-day course of antibiotic treatment to eradicate any infection. (35)

Upon close examination, Steere's guidelines appeared questionable. Steere had conducted studies in which he had treated patients with one of three antibiotics for ten days to see which antibiotic provided the best curative results. (36) Yet, the data in Steere's study showed that the number of Steere's patients who remained "sick" after a course of antibiotic treatment remained largely consistent with the numbers Steere had seen in previous studies before he had begun treatment with antibiotics. (37) The new results were attributable to a change in methodology; in the fine print of Steere's study, he noted that he had changed the definition of being "cured" of Lyme disease. (38) Instead of encompassing symptoms that were affecting Lyme patients in increasing numbers, the new treatment guidelines limited the symptoms of Lyme disease to joint infections and headaches. Everything else, Steere suggested, was simply an autoimmune reaction to the infection, or, more likely, had nothing to do with Lyme at all. (39) Perhaps unsurprisingly, Steere's research for this new study was funded in part by the Arthritis Foundation, (40) an unlikely organization to fund a study related to bacterial infection.

As Steere developed his own disease pathology for Lyme, physicians across the United States began to see more and more patients suffering from something that looked vaguely like Steere's Lyme disease. However, this new variation of Lyme that physicians saw springing up in their offices differed significantly from Steere's findings. (41) These patients did not fit the narrow definition of a viral infection that targeted the joints, consistent with Steere's findings. Rather these patients appeared to suffer from a multisystemic infection that caused debilitating results. (42) Suffering from symptoms ranging from long-lasting headaches and fatigue to blindness and deafness, these patients were sick and getting sicker, even after they had received Steere's standard ten-day treatment. (43)

Convinced partially by European research that indicated treatment success with antibiotics and otherwise by the responses they saw in their patients, doctors who refused to accept Steere's disease pathology witnessed dramatic results in their patients after extended use of antibiotic treatment. (44) These doctors began to develop their own ideas about the late stages of undiagnosed Lyme disease. (45) The stage was set for a showdown between Steere and those who believed in the existence of chronic Lyme disease.


Perhaps because of his emblematic role as the scientist who discovered Lyme disease, or perhaps due to his affiliation with Yale, Steere's guidelines were widely accepted. For others, the process of guideline promulgation is not always such a smooth road.

Recommendations for treatment, such as the duration of antibiotic intake, are just one type of practice guideline. Many individuals, groups, and government committees make practice guidelines on an extremely wide range of topics. (46) For this reason, guidelines are widespread in the healthcare industry. Their reach is so great that they affect almost all aspects of healthcare, including marketing of medical services, insurance reimbursements, and treatment practices. (47)

The Institute of Medicine defines practice guidelines as "systemically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances." (48) In particular, guidelines disseminate information from textbooks and peer-review journals (49) by providing standardized methods for physicians and other healthcare providers for use in treating patients. (50) By creating standards for treatment of different clinical conditions, doctors are able to streamline diagnosis and treatment while simultaneously guaranteeing that patients receive the best possible care according to recognized industry norms. (51)

Practice guidelines ideally reflect information that is based on the most current scientific research available. (52) Ensuring that this is the case often requires several rounds of revision and editing of the guidelines by those responsible for them. (53) This process ensures that outside parties will view the practice guidelines as coming from a legitimate source and as likely to achieve desirable outcomes in the treatment of patients. (54) If guidelines are not perceived as unbiased and useful, it is unlikely that they will be followed. (55) In this vein, Kathleen Lohr, an expert in clinical practice guidelines, (56) determined four important attributes of successful practice guidelines: reliability and reproducibility, scientific validity, clinical applicability, and clinical flexibility. (57) Others have stressed that the incentives involved in the development of guidelines matter as a measure of their usefulness. (58) "Routine maintenance" of guidelines, such as scheduled and documented review of existing guidelines, can help to assure outsiders that particular guidelines continue to be relevant and reflective of current scientific information. (59)

Practicing physicians or medical experts typically develop guidelines. (60) Most guidelines are promulgated by panels from a host of public and private sector actors, ranging from the Institute of Medicine and the National Institutes of Health (NIH) to the Harvard Community Health Plan and the RAND Corporation. (61) Guidelines are typically evidence-based, such as those developed by the Cochrane Collaboration, or consensus-based. (62) While many believe that practicing physicians are best suited to develop guidelines because they are "closer" to the practice of medicine in that they treat patients, (63) medical experts may provide insights to which physicians may not be privy. (64) Because the medical field is rapidly changing, physicians are often unable to keep abreast of changes in treatment plans. (65) Therefore, panels comprising both experts and physicians may produce guidelines that most realistically reflect current medical knowledge. (66) Additionally, while conventional wisdom has left patients out of this equation, they may be a useful tool and a source of important information in the promulgation of guidelines. (67) Inasmuch as practice guidelines restrict care to certain practices, patients may find that their values are no longer reflected when a guideline prohibits use of treatment that they find effective. (68)

Through the use of practice guidelines, healthcare providers and insurers seek to achieve several goals. While some guidelines are made for purely quality control reasons or financial gain, others seek to address problems plaguing the healthcare industry, such as high costs, varying quality of services, and the continual stream of malpractice litigation faced by healthcare providers. (69) Because so many different entities promulgate practice guidelines, some guidelines are more successful than others in achieving these goals. (70)

The issue of rising costs is particularly troublesome for the healthcare industry. In 2008 alone, the United States spent $2.3 trillion on healthcare. (71) These costs continue to grow each year. (72) Practice guidelines can help contain healthcare costs by providing specific rules about which treatments are and are not medically necessary. …

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