300,000 Americans are infected with Lyme each year. many are unaware they are infected

Imagine waking up one morning with numbness and tingling in your legs and arms and an excruciating pain that migrates throughout your joints and muscles, settling primarily in your hips and back. Your doctor takes a basic blood panel and orders a Magnetic Resonance Imaging (MRI) of the brain, yet the results indicate that there is nothing wrong with you.

The doctor suggests that it must be stress.

The neurologist tells you that the symptoms point to multiple sclerosis or other equally frightening neurological diseases. An agonizing four weeks pass as you undergo an electroencephalogram, an electromyogram, and an MRI of the cervical spine. These tests are all negative. The rheumatologists are also puzzled and subject you to another round of twenty to thirty blood tests. Hinting at hypochondria, these doctors suggest fibromyalgia, but further inquiry reveals that this is a “catch-all” disease with no specific symptoms, no cause, and no cure. Three years have passed, and there appears to be no other choice but to live with the pain.[1]

Reality for real people

Unfortunately, this is the life of thousands of Americans.[2] “Lyme disease is the most common tickborne infection in both North America and Europe,”[3] and according to the International Lyme and Associated Diseases Society (ILADS),[4] Lyme disease is the fastest-growing infectious disease in America, and it may be “occur[ing] at a rate five times higher than the number of new AIDS cases.”[5] Lyme disease is everywhere: if you take a walk in a field or the woods, you can encounter a tick carrying Lyme disease.[6] One estimate is that 300,000 Americans are infected with Lyme each year.[7] “And a lot of researchers believe that a billion people are infected.”[8] But in reality, no one knows the actual number of infected people with Lyme disease.
This article will explain what Lyme disease is, provide a brief history of Lyme disease, and explain why there is a controversy surrounding chronic Lyme disease. In addition, this article will explain how the chronic Lyme controversy led to Connecticut’s Attorney General filing “the first-ever antitrust investigation against a medical society’s guidelines development process.”[9] Although Connecticut’s Attorney General entered into a settlement agreement with the medical society,[10] this article will examine whether antitrust laws could be applied to a medical guideline development process. This examination is worthwhile because there are more than 2,300 clinical practice guidelines currently listed on the National Guideline Clearinghouse web site,[11] and some of these guideline development processes could face antitrust investigations in the future.

Lyme Disease—A Brief History

Lyme disease got its name in the late 1970s, when a cluster of children and adults living in Lyme, Connecticut, began experiencing unusual arthritic symptoms.[12] Consequently, many people are under the misconception that Lyme disease is a new disease that was discovered in the 1970s.[13] But the first known condition associated with Lyme disease was recorded in Germany in 1883.[14] Although the disease has been around for more than a century, the bacterium that causes Lyme disease, Borrelia burgdorferi (Bb bacteria), was not discovered until 1982.[15]

The black-legged deer tick[16] is the primary vector responsible for transmitting Lyme disease,[17] but research suggests that flies, gnats, mice, and mosquitoes can also transmit the Bb bacterium.[18] All vectors become infected when they bite an animal, usually a small mammal, bird, or deer,[19] which is already infected with the Bb bacteria.[20] The Bb bacteria “travels to local nerves and lymphatic channels, penetrates the blood stream, and can rapidly invade the brain without the host even knowing.”[21] There is also evidence that the Bb bacteria can also infect unborn children by crossing the placenta.[22] For example, in one case, a doctor concluded that a former Lyme patient’s eighteen-week-old fetus, which unexpectedly died in utero, died from Lyme disease because lab tests established that the baby was chromosomally normal, but “the fetus and placenta were PCR-positive[23] for Lyme bacteria.”[24]

The early stage of Lyme disease is generally characterized by a fever and flu-like symptoms, including fatigue, headache, and a mild stiff neck, and some patients develop a bull’s-eyed shaped skin rash known as erythema migrans (EM rash).[25] But every case is different, and many patients never develop the characteristic rash.[26] If the early stage of Lyme disease is left untreated or inadequately treated, it can progress and cause patients to suffer persistent health problems, such as crippling muscle and joint pain, disabling fatigue, arthritis, neurological disorders, and cardiac disorders,[27] leading to one of the biggest controversies surrounding Lyme disease—chronic Lyme disease.[28]

The actual number of Lyme-infected people is unknown for many reasons. First, many cases are never diagnosed because “laboratory tests have demonstrated serious limitations in reliability and accuracy.”[29] Moreover, many patients never know that an infected tick has bitten them because, unless engorged with blood, the deer tick is about “the size of a period at the end of [a] sentence.”[30] Second, the signs and symptoms of Lyme disease can be diverse, nonspecific, and often mimic those of many other diseases because the bacteria appear to activate the entire immune system, “resulting in a clinical presentation that looks exactly like lupus or rheumatoid arthritis (RA), and many other autoimmune diseases, including sarcoidosis, multiple sclerosis, Parkinson’s, ALS,[31] and lupus.”[32] Third, physicians have been reluctant to treat or diagnose patients suffering from Lyme disease because many physicians who have reported a large number of Lyme cases or who have treated patients with long-term antibiotics have been the “targets of State health department investigations.”[33] For example, in 2001, only eleven doctors in New York State were willing to use long-term antibiotics to treat patients with chronic Lyme disease. And of these eleven doctors, at least three were under investigation.[34] Although the identity of the complainants was kept secret by law, many people, including Assemblyman Joel M. Miller of Poughkeepsie, were convinced that the complaints “c[a]me from the insurance industry.”[35] Fourth, many states no longer require doctors to report confirmed Lyme disease cases.[36] Consequently, the actual number of Lyme-infected people is unknown, but is it probably more prevalent than reported or thought.

Infectious Diseases Society of America Guidelines

The Infectious Diseases Society of America (IDSA) is a nonprofit corporation[37] that “represents over 8,000 physicians, scientists, and other health care professionals who specialize in infectious disease.” [38] The IDSA panel members have always believed that Lyme disease can be easily treated, and cured, with short-term antibiotics.[39] And physicians who treat chronic Lyme patients have, for years, complained about members of the IDSA panel and their proposed treatment plans.[40] In 2000, the IDSA issued its first set of Lyme treatment guidelines,[41] and doctors who treat Lyme patients, the Lyme Disease Association (LDA), and two of LDA’s affiliates[42] spoke out against the IDSA guidelines, complaining that the guidelines were too restrictive to properly treat and diagnose chronic Lyme patients.[43] These complaints have had dire consequences. From 1997 to 2000, “about 50 physicians in New York, New Jersey, Connecticut, Michigan, Oregon, Rhode Island and Texas had been investigated, disciplined or had had their licenses removed”[44] because these physicians used long-term antibiotic therapy instead of the short course recommended by the IDSA guidelines.[45] One such physician, John Bleiseiss, eventually committed suicide after the New Jersey Board of Medical Examiners charged him with inappropriate diagnosis and treatment of Lyme disease.[46]

In 1993, Dr. Joseph Burrascano, Jr., an internationally known infectious disease specialist,[47] made the following statements at a hearing before the Senate Committee on Labor & Human Resources, which was the first Lyme hearing:

There is in this country a core group of university-based Lyme disease researchers and physicians whose opinions carry a great deal of weight.

Unfortunately, many of them act unscientifically and unethically. They adhere to outdated, self-serving views and attempt to personally discredit those whose opinions differ from their own. They exert strong, ethically questionable influence on medical journals, which enables them to publish and promote articles that are badly flawed. They work with Government agencies to bias the agenda of consensus meetings and have worked to exclude from these meetings and scientific seminars those with ultimate opinions.

They behave this way for reasons of personal or professional gain and are involved in obvious conflicts of interest.

. . . [T]hese individuals who promote this so-called “post Lyme syndrome” as a form of arthritis depend on funding from arthritis groups and agencies to earn their livelihood. Some of them are known to have received large consulting fees from insurance companies to advise the companies to curtail coverage for any additional therapy beyond the arbitrary 30-day course.[48]

Two months after Dr. Burrascano’s testimony, New York’s Office of Professional Medical Conduct (OPMC) began an intensive seven-year investigation of Dr. Burrascano because he treated chronic Lyme patients with long-term antibiotics.[49] Eventually, the OPMC hearing panel cleared him of any wrongdoing relating to his treatment of Lyme patients.[50]

Because the IDSA’s 2000 Guidelines were too restrictive and did not even address chronic Lyme disease, Lyme patients were unable to get properly diagnosed and treated.[51] Consequently, in mid 2006, the LDA and two of its affiliates[52] appealed to Connecticut Attorney General Richard Blumenthal (AG Blumenthal), explaining that Lyme patients were being denied insurance coverage and doctors who treated Lyme patients were being investigated and prosecuted because their treatments did not conform to the 2000 IDSA Guidelines.[53]

A few months after the LDA and its affiliates appealed to AG Blumenthal, the IDSA issued a new set of guidelines, the 2006 IDSA Guidelines,[54] which were even more restrictive.[55] Shortly thereafter, AG Blumenthal served the IDSA with a Civil Investigative Demand (CID) because he was concerned that the 2006 IDSA Guidelines violated antitrust laws by restraining “doctor and patient choices for treatment of the disease,”[56] and preventing physicians’ clinical judgment.[57]

AG Blumenthal never filed an antitrust lawsuit against the IDSA because both parties entered into a settlement agreement on April 30, 2008.[58] The settlement required the IDSA to “implement an Action Plan”[59] and convene a new and independent panel[60] to assess whether its “2006 Lyme disease Guidelines should be revised or updated.”[61] In addition, the settlement agreement required the panel to “conduct an open scientific hearing . . . [to] hear scientific and medical presentations from interested parties”[62] and decide if “each recommendation in the IDSA’s 2006 Lyme disease guidelines . . . is supported by the scientific evidence.”[63] If seventy-five percent of the panel members do not vote to sustain a recommendation, the recommendation must be revised.[64] The agreement also stipulated that the 2006 IDSA Guidelines would remain in place unless the new panel determines that the guidelines should be modified or replaced.[65] On July 30, 2009, the new IDSA panel[66] held a one-day hearing in Washington, D.C., and heard testimony from eighteen speakers, including patients, physicians, and research scientists.[67] According to AG Blumenthal, the “hearing accomplished a key goal—compelling a fair and full discussion, free of conflicts of interest by panelists, so that all scientific facts and perspectives are considered before medical guidelines are established.”[68]

The new panel did not release its report until April 22, 2010.[69] According to the Review Panel, “the 2006 Lyme Guidelines were based on the highest-quality medical/scientific evidence available at the time and are supported by evidence that has been published in more recent years.”[70] In addition, the Review Panel found “that the authors of the 2006 Lyme Guidelines had [not] failed to consider or cite relevant data and references that would have altered the published recommendations.”[71] Therefore, based on the Review Panel’s findings, the 2006 IDSA Guidelines will remain in place, for now.[72] Although this is not the outcome that Lyme sufferers had hoped for, the Final Report’s conclusion did provide one statement that could be helpful to Lyme sufferers and the doctors who treat them:

· “Guidelines are not intended to be (and cannot be) rigid dicta, inflexible rules, or requirements of practice.”[73]

Because the Final Report stated that guidelines cannot be “inflexible rules or requirements of practice,” state medical boards should not be able to use the 2006 Guidelines to investigate doctors whose treatment plans do not conform to the Guidelines. As such, perhaps more doctors will be willing to use long-term antibiotics to treat patients suffering from chronic Lyme disease.

Although AG Blumenthal never filed an antitrust lawsuit against the IDSA, it is still worth examining if antitrust laws could be applied to the IDSA’s guideline development process. There are more than 2,300 clinical practice guidelines currently listed on the National Guideline Clearinghouse Website,[74] and if antitrust laws could be applied to the IDSA’s guideline development processes, some of these other medical societies could face antitrust investigations in the future.

Applying Antitrust Principles to the IDSA’s Guideline-
Development Process

The Chronic Lyme Disease Controversy

As stated earlier, the IDSA developed two sets of Lyme treatment guidelines—the 2000 and the 2006 IDSA Guidelines.[75] Before one can understand whether antitrust principles could be applied to the IDSA’s Lyme guideline development process, it is important to understand the chronic Lyme disease controversy and why the 2006 IDSA Guidelines are problematic for Lyme sufferers and the doctors who treat them. Although both guidelines have had significant impacts on Lyme disease medical care and have been used to investigate and sanction doctors who fail to follow the IDSA-suggested treatment,[76] the remainder of this article will concentrate on the information contained in the 2006 IDSA Guidelines because it is the version that is currently endorsed by the IDSA.[77]

According to the National Guideline Clearinghouse, “[c]linical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”[78] The IDSA claims that the main objective of its 2006 IDSA Guidelines is “[t]o provide clinicians and other health care practitioners with recommendations for the management of patients in the United States with suspected or established Lyme disease.”[79] Because medical guidelines are intended to assist practitioners and patients about appropriate health care, they should be based on all available scientific evidence. But when the IDSA developed its Lyme treatment Guidelines, it “refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease.”[80]

The 2006 IDSA Guidelines are also problematic because they actually “promote the idea that Lyme is a simple, rare illness that is easy to avoid, difficult to acquire, simple to diagnose, and easily treated and cured with 30 days of antibiotics.”[81] This is simply not true. Lyme disease “often goes undiagnosed for months, years, or even forever in some patients, and [it] can render the patient chronically ill and even totally disabled.”[82] In addition, Lyme patients are often misdiagnosed because Lyme disease can manifest itself in many different ways.[83] Lyme patients have been misdiagnosed with numerous conditions, including chronic fatigue syndrome, fibromyalgia, amyotrophic lateral sclerosis,[84] multiple sclerosis, heart disease, and numerous neurological and psychological conditions,[85] such as autism, strokes, and bipolar disorder.[86]

The IDSA and its 2006 Guidelines are emphatic that antibiotics should not be used for more than a month.[87] But even when Lyme patients receive the IDSA-recommended treatment, many patients do not respond to this treatment and continue to have symptoms for years,[88] suggesting that a chronic form of the disease exists.[89] This, in turn, has led to the most controversial and problematic issue with the 2006 IDSA Guidelines—chronic Lyme disease.

Even though there are “more than 19,000 scientific studies on tick-borne diseases” that suggest chronic Lyme disease exists,[90] doctors and researchers who follow the IDSA guidelines dismiss the notion that a Lyme infection can persist after a thirty-day dose of oral antibiotics and condemn the use of long-term antibiotics,[91] claiming they are useless and potentially harmful.[92] But the ILADS has a divergent view: persistent and recurring symptoms demonstrate a continuing and chronic infection,[93] which does not always respond to the IDSA’s limited duration of two to four weeks of antibiotic treatment.[94] And despite all of the evidence concerning chronic Lyme disease, the 2006 IDSA Guidelines actually dismiss chronic Lyme disease as nothing more than “the aches and pains of daily living.”[95] The IDSA’s dismissal of the existence of chronic Lyme is problematic because the 2006 ISDA Guidelines have been “widely cited [by many doctors and insurance companies] for conclusions that chronic Lyme disease is nonexistent.”[96]

The opposing view, which is held by the ILADS and the doctors who treat chronic Lyme patients, is that the IDSA’s 30-day treatment course is “arbitrary.” [97] This opposing view is supported by a substantial body of scientific evidence that demonstrates that many chronic Lyme patients have obtained relief from their pain and suffering, and some have been cured by the use of long-term antibiotics, including intravenous antibiotics.[98] The doctors who treat chronic Lyme patients have further condemned standardized guidelines, such as the 2006 IDSA Guidelines, arguing that these guidelines prevent them from using their own clinical judgment in diagnosing and treating Lyme disease.[99]

Besides persistent health problems, such as crippling muscle and joint pain, disabling fatigue, arthritis, neurological disorders, and cardiac disorders,[100] when the Lyme bacteria invade the brain, many chronic Lyme patients also suffer from depression, thoughts of suicide, “brain fog,” [101] “headache, . . . weakness, memory or concentration difficulties, . . . clumsiness, bladder or bowel dysfunction, . . . [and] visual loss.”[102] Because many antibiotics do not effectively penetrate the blood-brain barrier, these antibiotics are not transported to the brain.[103] Consequently, these patients must be treated with intravenous antibiotics because when the antibiotics are “delivered directly into the blood, they bypass the digestive system where some of the medication is lost.”[104] And even though chronic Lyme sufferers often respond to intravenous antibiotic therapy,[105] the 2006 IDSA Guidelines do not recommend intravenous antibiotic treatment for any Lyme patients.[106]

[1]. Interview with Lyme Disease Sufferer, in Auburn Hills, Mich. (Mar. 2, 2009).

[2]. See Examining the Adequacy of Current Diagnostic Measures and Research Activities in the Prevention and Treatment of Lyme Disease: Hearing Before the S. Comm. on Labor & Human Res., 103d Cong. 54, 56 (1993) [hereinafter 1993 Hearing] (statement of Dr. Joseph Burrascano, Jr., Physician) (stating that some patients have seen more than 40 “different physicians over several years before being properly diagnosed”); Stephen Smith, Diagnosis: Controversy More Than Two Decades Since the Threat of Lyme Disease was Recognized, Doctors and Patients are Still Warring over how to Identify and Treat it, Bos. Globe, June 25, 2007, http://www.boston.com/news/globe/health_science/articles/2007/06/25/diagnosis_controversy/. Dr. Raphael Stricker, past-president of the International Lyme and Associated Diseases Society (ILADS), states that most patients have “been to 10 to 20 doctors who can’t diagnose them.” Id.

[3]. Gary P. Wormser, et. al., Infectious Diseases Soc’y Am., The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America, 1089 (2006) [hereinafter 2006 IDSA Guidelines].

[4]. “ILADS is a nonprofit, international, multi-disciplinary medical society dedicated to the diagnosis and appropriate treatment of Lyme and its associated diseases.” ILADS, About ILADS, Int’l Lyme & Associated Diseases Soc’y, http://www.ilads.org/about_ILADS/about_us.html (last visited Oct. 10, 2010).

[5]. ILADS, ILADS Lyme Disease Treatment Guidelines Summary, Int’l Lyme & Associated Diseases Soc’y, http://www.ilads.org/lyme_disease/treatment_guidelines_summary.html (last visited Oct. 10, 2010).

[6]. See 1993 Hearing, supra note 2, at 54-55.

[7]. Press Release, Int’l Lyme & Associated Diseases Soc’y, Historic Hearings on Most Controversial Disease in U.S. (July 26, 2009), available at http://www.ilads.org/news/lyme_press_releases/60.html; see also Kenneth B. Singleton, The Lyme Disease Solution, at xxi (2008) (stating that each year, the CDC “reports more than 20,000 diagnosed cases of Lyme disease in the United States, but . . . [s]ome estimates place the actual number of cases at 10 times or more higher than reported cases”).

[8]. In Re Lyme Disease: Public Hearing Before the Conn. Dep’t of Pub. Health, 177, 179 (Conn. Jan. 29, 2004) (statement of Dr. Stephen Sinatra, Cardiologist), available at http://www.ct.gov/ag/lib/ag/health/0129lyme.pdf.

[9]. Press Release, Lyme Disease Ass’n, Settlement Announced in Landmark Investigation of Lyme Disease Diagnosis and Treatment Guidelines (May 1, 2008), available at http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=308.

[10]. See An Agreement Between the Attorney General of the State of Connecticut and the Infectious Diseases Society of America (2008) [hereinafter 2008 Settlement Agreement], available at http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf. Connecticut’s Attorney General, Richard Blumenthal, investigated the Infectious Diseases Society of America (IDSA), for anti-trust violations. Press Release, Lyme Disease Ass’n, supra note 9.

[11]. Guidelines by Topic, Nat’l Guideline Clearinghouse, http://www.guideline.gov/browse/by-topic.aspx (last visited Oct. 10, 2010). Interestingly, the 2006 IDSA Lyme Guidelines are listed on the National Guideline Clearinghouse Website, but the ILDSA Guidelines are not listed on the Website. See Guideline Summary, Nat’l Guideline Clearinghouse, http://www.guideline.gov/content.aspx?id=9537&search=lyme+guidelines (last visited Oct. 10, 2010).

[12]. A Brief History of Lyme Disease in Connecticut, Conn. Dep’t of Pub. Health, http://www.ct.gov/dph/cwp/view.asp?a=3136&q=388506 (last modified June 2, 2010); Singleton, supra note 7, at 13.

[13]. Where did Lyme Disease Come From? Is it New?, Lyme Disease Found., http://www.lyme.org/ld_history.html (last visited Oct. 10, 2010).

[14]. Id.; see also Singleton, supra note 7, at 14.

[15]. A Brief History of Lyme Disease in Connecticut, supra note 12; see also Singleton, supra note 7, at 4, 13.

[16]. The scientific name for the black-legged deer tick is Ixodesscapularis. Press Release, Infectious Diseases Soc’y Am., Updated Guidelines on Diagnosis, Treatment of Lyme Disease (Oct. 2, 2006) [hereinafter Press Release, IDSA], available at http://www.idsociety.org/Content.aspx?id=3744.

[17]. See id.

[18]. Singleton, supra note 7, at 6.

[19]. See Press Release, IDSA, supra note 16.

[20]. See Constance A. Bean with Lesley Ann Fein, Beating Lyme: Understanding and Treating This Complex and Often Misdiagnosed Disease, at xii (2008); Singleton, supra note 7, at 5.

[21]. Bean, supra note 20.

[22]. See id. at 174.

[23]. PCR is an acronym for polymerase chain reaction.

[24]. In Re Lyme Disease, supra note 8, at 57 (statement of Elise Brady, Lyme Disease Patient).

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