Connecticut’s Antitrust Action against IDSA’s Lyme Guidelines: Medical Guideline Development Demands Scientific Procedures

        Lyme disease is the fastest-growing infectious disease in the U.S.[1] However, the bacteria that causes the disease was only discovered in 1982,[2] and Lyme specialists still disagree over how to diagnose and treat the disease.[3] The Infectious Diseases Society of America’s (IDSA) Lyme guidelines deepens the controversy by completely rejecting the use of clinical discretion to diagnose patients and the use of long-term treatment.[4] While IDSA refers to its guidelines as “voluntary,” major insurers use them to deny coverage for long term antibiotic therapy.[5] Consequently, patients frequently have extreme difficulty obtaining long term treatment.[6] Responding to complaints by patient groups who supported long-term treatment and were excluded from the guideline writing process, Connecticut’s Attorney General Richard Blumenthal conducted an antitrust investigation into IDSA’s guidelines.[7] In May 2008, Blumenthal concluded the investigation and announced flaws in the guidelines’ development, including: panelists’ connections to insurance and vaccine companies in violation of antitrust principles, failure to review potential conflicts of interest, bias in the selection committee, exclusion of dissenting panelists, failure to significantly evaluate contradictory evidence., misrepresentation of the guideline authors’ views as independent and misrepresentation of the guidelines as voluntary.[8] The Attorney General’s antitrust action resulted in a settlement, which required that the guidelines be reviewed by a completely new panel that is free of conflicts of interest and represents a range of views.[9] Patient advocates criticize the resulting review panel because its chairperson was a former IDSA president, it excluded panel candidates who supported long-term treatment, and it failed to vote on the scientific basis for IDSA’s diagnostic requirements.[10] The review panel’s final report decided: (1) the guidelines should be updated to give doctors discretion in diagnosing patients who have a high probability of Lyme but only equivocal tests; and (2) antibiotics are not recommended to treat patients beyond a short 28 day treatment.[11] Analysis confirms the Attorney General’s antitrust findings, so he should modify the review panel to ensure the settlement’s requirements for an unbiased, scientific review.

  1.         Background

        With 35,198 new cases reported to the U.S. Centers for Disease Control (CDC) in 2008,[12] “Lyme disease accounts for 90% of all vector-borne infections” in the U.S.[13] In fact, CDC estimates the number of actual cases to be 6-12 times higher than reported.[14] The carriers or “vectors” of Lyme disease are Ixodes Scapularis and the western black-legged tick Ixodes Pacificus.[15] The disease is caused by Borrelia burgdorferi, a spirochetal bacteria like syphilis.[16] Early signs of Lyme include fever, headache, fatigue, and an “erythema migrans” (EM) rash.[17] Late-stage Lyme can cause “severe permanent physical complications”[18] involving the joint, heart, eye, and nervous systems.[19] 

  1.         Disagreeing Guidelines

        Two different sets of Lyme treatment guidelines exist: those of the IDSA’s and those of the International Lyme and Associated Diseases Society (ILADS).[20] While IDSA is a private professional organization,[21] it enjoys government preference.[22] CDC links to IDSA’s guidelines instead of ILADS’ guidelines.[23]

        IDSA’s guidelines state: “Clinical findings are sufficient for the diagnosis of erythema migrans, but clinical findings alone are not sufficient” to diagnosis other signs of Lyme.[24] Patients without an EM rash must have 2 positive tests “using the 2-tier testing algorithm recommended by… CDC.”[25] The requirement that patients have an EM rash or positive 2-tier test matches the CDC’s surveillance definition, which states: “This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis.”[26] CDC epidemiologist Paul Mead explains: “Whereas physicians appropriately err on the side of over-diagnosis, thereby assuring they don’t miss a case, surveillance case definitions appropriately err on the side of specificity, thereby assuring that they do not inadvertently capture illnesses due to other conditions.”[27] CDC reports that only 68% of Lyme patients meeting its surveillance definition have EM rashes.[28] Its 2-tier test requires positive ELISA and Western Blot tests for a diagnosis.[29] In developing its criteria, CDC relied on studies showing this 2-tier approach had sensitivities of 33% and 57% for early and late stage Lyme respectively.[30] This scheme leaves untreated 22% of patients with early stage Lyme and 43% of late stage Lyme patients, since standard EM rashes vanish after early stage Lyme.[31] Critics complain that the guidelines treat tests as infallible and ignore clinical judgment.[32]

        IDSA guidelines recommend only 10-28 days of antibiotics, even for late-stage neurological Lyme.[33] They say: “there is no convincing biologic evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment... Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic (> 6 months) subjective symptoms after administration of recommended” 10-28 day treatment.[34] Panelists elsewhere said Lyme’s successful yield rate for blood cultures is below 10%,[35] yet the guidelines call cultures the “gold standard” for the bacteria’s viability unless fully proven by other methods.[36] The guidelines rejected a study that used a new method to culture the bacteria in 97% of 47 guideline-treated patients because the germ was found with microscopes, not DNA tests, and because two other studies with 22 guideline-treated patients couldn’t culture it.[37] The guidelines admit that mice can have positive cultures after guideline treatments, but say there is “no evidence” that surviving Lyme bacteria can cause the disease.[38] The lack of a test to see if a patient is cured, and the illness’s occasional quiescence compound the disagreement.[39] 

Instead of chronic Lyme, IDSA’s guidelines say chronically ill patients suffer from post-Lyme syndrome, which they define as “unexplained chronic subjective symptoms following treatment with recommended antibiotic regimens”[40] Proponents of long-term treatment point out there is no “specific biologic marker for ‘post-Lyme syndrome’… It is more likely that ‘post-Lyme syndrome’ represents a failure of restricted antibiotic therapy to clear the infection.”[41]

In contrast to IDSA’s guidelines, ILADS’ guidelines, advocate using both tests and clinical judgment to diagnose Lyme, instead of using fallible testing criteria to exclude patients from treatment.[42]  ILADS doctors say clinical judgment is important to see if treatment is working or if changes are needed.[43] They add together symptoms ranging from headaches, joint and muscle pain and weakness, light sensitivity and fatigue because the spirochete infects multiple organs.[44] They point out that reliance on clinical data is common in diagnosing other illnesses.[45]ILADS guidelines recognize that Lyme can persist despite 28 days of antibiotics, so the duration of treatment could extend beyond 28 days, depending on the patient’s clinical responsiveness.[46] Unlike IDSA’s guidelines, ILADS’ guidelines add that some patients require higher dosages of antibiotics or combination antibiotic therapy.[47]

  1.         The Connecticut Attorney General’s Investigation

Behind the backdrop of the scientific debate about the guidelines, the Attorney General discovered that “IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel… Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest.”[48] Blumenthal pointed to the panelists’ financial interests “in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies.”[49] 

The guidelines only reported conflicts of interests for five panelists: Dr. Gary Wormser, the panel chair, received funds “from Baxter and… Immunetics, and… is a founder of Diaspex,” R.J. Dattwyler, “a speaker for Pfizer and… part owner of Biopeptides,” J.J. Halperin, an expert witness on behalf of Lymerix (GlaxoSmithKline), A.C. Steere, a consultant for Baxter, and P.J. Krause, a developer of a diagnostic procedure for a coinfection of Lyme.[50] Elsewhere, Wormser disclosed receiving “grants related to Lyme disease from Bio-Rad… Biopeptides… Merck and AstraZeneca…, owning equity in Abbott…, and being retained in… medical-malpractice cases involving Lyme disease,” Dattwyler elsewhere disclosed a financial connection to Baxter and serving as an expert witness in medical malpractice actions, and Steere disclosed a financial connection to GlaxoSmithKline and Viramed.[51] A sixth panelist, Eugene Shapiro, elsewhere admitted to receiving grants for Lyme vaccines, testifying in Lyme-related medical malpractice actions, and reviewing Lyme disability claims for Metropolitan Life insurance. [52]

Some panelists ran trials for the first Lyme vaccine, which was withdrawn after patients reported serious arthritic side effects.[53] Conflicts of interest are problematic because panelists may consider commercial interests over patient interests in setting guidelines.[54] Restrictive diagnosis guidelines favor vaccine companies because they make vaccinated patients appear less susceptible to re-infection.[55] 2-tier test requirements favor test manufacturers, while guidelines denying chronic Lyme favor insurers because they can deny payment for long-term treatment.[56] 

After the investigation, IDSA president Anne Gershon claimed that panelists’ development of vaccines was irrelevant because they weren’t developed at the same time as the guidelines.[57] Despite this claim, panelists could still have kept in mind the interests of vaccines they had developed or planned to develop while writing the guidelines. Gershon tried to justify panelists’ testimony as expert witnesses against doctors who treated outside the guidelines, portraying the testimony as an acceptable “professional activity” where “compensation is relatively modest.”[58]

The Attorney General found “improper links” between IDSA’s and the American Academy of Neurology’s (AAN) Lyme panels.[59] The “panels shared key members, including the respective panel chairmen and were working on both sets of guidelines at the same time -- a violation of IDSA's conflicts of interest policy… When IDSA learned of the improper links… it aggressively sought AAN’s endorsement.”[60] Their guidelines used “strikingly similar language” to conclude chronic Lyme didn’t exist and defined symptoms persisting after treatment as “Post-Lyme Syndrome” in the same way.[61] IDSA portrayed AAN’s guidelines as independent corroboration and tried using them to defeat legislation supporting long-term Lyme treatment.[62]

The Attorney General also found that “IDSA failed to follow its own procedures for appointing” panelists.[63] IDSA’s procedures say guideline panels should have “a range of experts that is sufficiently broad enough to adequately explore the topic,” and “are strongly encouraged to include members of relevant professional societies and to work toward consensus.”[64] Yet the Attorney General found that the 2006 Lyme panel’s chairman, “who held a bias regarding the existence of chronic Lyme,” handpicked a likeminded panel without the IDSA oversight committee’s approval.[65] When a dissenting member of IDSA’s 2000 Lyme guidelines panel argued that chronic Lyme exists, the panel pressured him to conform, and removed him when he refused.[66] In 2002, the New England Governors’ Conference passed a resolution recognizing: “consensus guidelines for diagnosis and treatment of long-term Lyme disease have yet to be developed.”[67] When scientists with divergent views on chronic Lyme sought to join the 2006 panel, IDSA told them it was fully staffed, although the panel was later expanded.[68] 

The biased 2000 and 2006 Lyme panels then proceeded to write the guidelines in a flawed manner. The Attorney General found they excluded “divergent medical evidence and opinion” and “refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease.”[69] IDSA categorizes its evidence as: Level I randomized controlled trials, Level II nonrandomized clinical trials, and Level III “Evidence from opinions of respected authorities.”[70] 38 of 71 Lyme panel recommendations were based only on the weakest kind of level III evidence, the panelists’ “expert opinion.”[71] IDSA’s rules on writing guidelines say that "The basis on which expert opinion was formed should be specified."[72] The Lyme guidelines’ list of “not recommended” treatments relies on Level III evidence, with the generalized explanation that they lack “plausibility,” “efficacy,” or “supporting data,” or could harm patients.[73] The guidelines give no citations or further explanations about many treatments on the “not recommended” list like metronidazole.[74] Studies show metronidazole to be more effective in fighting the Lyme bacteria’s defensive “cyst” form than more traditional medicines.[75] The guidelines flatly rejected Lyme doctors’ “open label studies” (Level II evidence) because: the disease has “no objective findings,” antibiotics’ anti-inflammatory properties could have reduced inflammation (an objective finding), and “many of” the studies didn’t use 2-tier testing.[76]

Gershon later denied that the panel was limited to researchers “known to have a bias” on Lyme and claimed that it surveyed all the Lyme research but rejected studies lacking “scientific rigor.”[77] Yet IDSA’s critics pointed out that 40% of the research cited in the guidelines was authored by the panelists themselves.[78] Gershon denied that any studies in “peer-reviewed medical literature proved the benefits of long-term treatment outweighed its risks.” [79] But in fact some peer-reviewed, published studies showed significant benefit from long-term treatment.[80] The U.S. Food and Drug Administration found antibiotic therapy, including long-term oral antibiotics for Lyme, to be generally safe and physically well tolerated.[81]

IDSA’s guideline-writing principles state: “Practice guidelines . . . are never a substitute for clinical judgment. Clinical discretion is of the utmost importance in the application of a guideline to individual patients, because no guideline can ever be specific enough to be applied in all situations.”[82] This principle is correct, because to disregard clinical judgment is to disregard the doctor’s past clinical experiences, the patient’s history, course of treatment, and responsiveness to treatment.[83] Yet IDSA’s Lyme guidelines state that clinical judgments besides observance of an EM-rash are insufficient to diagnose Lyme, and they oppose treatment beyond 28 days regardless of clinical judgment.[84] Should the guidelines’ non-clinical recommendations fail, they leave the doctor and patient without treatment options.[85]

The Attorney General found that the flawed guidelines “have sweeping and significant impacts on Lyme disease medical care.”[86] His report considered the situation “unusual” because:

IDSA included in its Lyme guidelines a statement calling them "voluntary" with "the ultimate determination of their application to be made by the physician in light of each patient's individual circumstances." In fact, United Healthcare, Health Net, Blue Cross of California, Kaiser Foundation Health Plan and other insurers have used the guidelines as justification to deny reimbursement for long-term antibiotic treatment.[87]

He added that the guidelines “strongly influence physician treatment decisions” and are “widely cited for conclusions that chronic Lyme is nonexistent.”[88]

Insurance companies naturally seek to implement guidelines that restrict costs.[89] For example, Dr. David Eddy, senior adviser to insurance provider Kaiser Permanente, states that “whoever controls practice policies controls Medicine,” and “the fight to control health care costs” must address doctors’ treatment decisions.[90] While they could be accountable for violating a standard of care, insurers are not held accountable for following a standard set by the flawed guidelines of a specialty association like IDSA.[91] Further, when Independent Review Organizations (IROs) review claims against insurance companies and family doctors who are outside insurance networks, the IROs rely on specialty societies’ guidelines for their decisions.[92] 

Consequently, insurance companies often refuse to reimburse treatments that extend beyond restrictive guidelines.[93] Other insurance companies require the second opinion of an “infectious disease” specialist for those treatments.[94] In one case, Dianita Thomas-Wilson could not afford to pay for her Lyme therapy when Keystone Health Plan refused to cover the treatment.[95] She could not afford treatment so her condition worsened for 4 months while she experienced severe neck pain, back pain, and emotional problems, requiring a personal caretaker.[96] Keystone only approved payment after she met its added requirements of an EEG, an X-Ray, and a specialist’s confirmation of her diagnosis.[97]

In an insurance-dominated environment, guidelines serve to expand the influence of specialty societies.[98] Insurance companies and hospitals use economic profiling to pressure their doctors to conform to cost parameters or restrictive guidelines in providing treatment.[99] Since the livelihoods of specialty societies’ members depend on their guidelines’ acceptance by insurance companies, specialty societies are particularly aware of insurers’ goals.[100]

Consequently, IDSA provides second opinions to support insurers’ denials of care for long-term treatment, and testifies at unprofessional conduct hearings against doctors who don’t obey its guidelines.[101] Meanwhile, it controls the debate through positions on editorial boards, peer-review journals, and medical conferences.[102] For example, IDSA publishes the Journal of Infectious Diseases, “the premier publication in the Western Hemisphere for… research on… infectious diseases” and Clinical Infectious Diseases, “one of the most heavily cited journals in the fields of infectious diseases.”[103] AAN, whose Lyme panel included IDSA panelists and wrote matching guidelines, publishes Neurology Journal, “the most widely read and highly cited peer-reviewed neurology journal.”[104] Insurers, hospitals, government agencies, and medical boards uncritically adopt their views on Lyme.[105] In fact, a federal law signed in 2002 expresses “distress” that CDC’s restrictive surveillance definition of Lyme, which matches the guidelines’ diagnosis requirement, is “misused as a standard of care for healthcare reimbursement, product development, [and] medical licensing hearings.”[106] Patients with insurance who seek treatment outside the guidelines must pay for treatment on their own or go untreated.[107]

Gershon responded to criticisms by saying: "guidelines are simply that, guidelines, and by their very nature do not “exclude” patients, nor “deny” them treatment."[108] But regardless of whether guidelines claim to be voluntary, they have a mandatory effect when hospitals use them to deny patients care.[109] Thus, when Gershon said that IDSA’s critics had conflicts of interest because they could gain financially from treating patients long-term, critics could point to a significant difference in their positions.[110] Patients unhappy with long-term treatment can leave their doctors, who are accountable for the care.[111] But when a dominant medical society’s guidelines set the rules for their care, patients have no recourse when those rules fail.[112] 

Doctors fear medical board investigations and censure if they treat outside the guidelines, which are seen as “mainstream.”[113] The complaints are investigated by insurance companies. [114]  Charles M. Cutler, chief medical officer of the American Association of Health Plans, explains their view that:"Many patients aren't being appropriately diagnosed. When they are sent to medical centers with broad experience, it turns out they don’t meet the criteria [i.e. the guidelines]... When something is amiss, plans have filed complaints with medical boards.”[115] 

According to attorney Michael Schoppmann, who represented over 40 doctors at board hearings, "It's almost certain that if a physician treats a significant number of patients with Lyme for an extended period, he'll be investigated by health plans and licensing authorities.”[116] One of Schoppmann’s clients, Dr. Joseph Burrascano, who is ILADS’ vice-president, “treated more than 7,000 Lyme patients from around the world over the past 15 years.”[117] In 2000, New York’s Office of Professional Conduct issued 39 charges against Burrascano for treating patients with long-term antibiotics.[118] 400 patients attended a rally in the doctor’s favor, some of whom “complained that their medical files had been used by the state without their knowledge.”[119] In 2002, New York's Administrative Review Board for Professional Medical Conduct rejected nearly all charges, but still placed Dr. Burrascano on 2 years’ probation, primarily for giving patients what it considered “unwarranted treatment” for Lyme.[120] The ARB’s decision affirmed an earlier finding of NY’s Board of Professional Medical Conduct, which rejected the charges of fraud and incompetence and recognized that IDSA’s guidelines should not have the legal force of government regulations.[121]

California’s Medical Board charged Dr. Therese Yang with gross negligence and incompetence.[122] Yang is one of only ten doctors in California who treat chronic Lyme, out of forty who treat Lyme there.[123] Unlike Yang, who treats over 600 Lyme patients, the Medical Board does not recognize the existence of chronic Lyme.[124] It described one of the patients in the complaint, Angel Vipond, as having a “severe psychiatric illness” instead of Lyme.[125] Vipond, whom four other doctors diagnosed with Lyme, says Yang “is really getting knocked on. That is really, really wrong."[126] Fighting the charges will cost Yang about $140,000.[127]

A few states recognize these obstacles and passed protective statutes. In 2004, Rhode Island passed a law stating: “No physician is subject to disciplinary action… solely for prescribing, administering or dispensing long-term antibiotic therapy for… Lyme”,[128] and another law requiring insurance companies to cover long-term Lyme treatment.[129] That year, Connecticut also passed a law requiring insurers to cover long-term treatment under certain conditions.[130] In 2005, California amended its statute protecting doctors who provide alternative medicine to explicitly include treatment for persistent Lyme.[131] 

As a result of doctors’ fear to treat outside the guidelines, patients incur extreme difficulty and expense in finding doctors who treat persistent Lyme.[132] The few California doctors who provide long-term treatment have waiting lists 500 patients long.[133] Other patients are commonly misdiagnosed with conditions besides Lyme.[134] In an environment where IDSA teaches that Lyme is a rare disease,[135] it is no surprise that CDC finds that Lyme is underreported by about 200,000 cases a year.[136] An Iowa study blames lack of providers’ awareness of Lyme for the underreporting.[137] 

  1.         Legal Basis for the Antitrust Action

According to the Sherman Antitrust Act, “Every contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce among the several States... is declared to be illegal.”[138] While the Attorney General did not release the confidential details of its legal analysis of the investigation, it finds support in antitrust principles and precedents.[139] That is because “private standard-setting associations have traditionally been objects of antitrust scrutiny.” As the U.S. Supreme Court explains, their standards are implicit agreements not to perform certain types of commerce and thus “have a serious potential for anticompetitive harm.”[140]

In Allied Tube & Conduit Corp. v. Indian Head, Inc., the Supreme Court found that the Sherman Act prohibits decision-makers who share an “economic interest in restraining competition” from biasing an industry’s standard-setting process by stacking a “private standard-setting body.”[141] There, the Supreme Court affirmed a Second Circuit decision, which found that stacking an association’s meeting is “inconsistent with the concept of ‘consensus’ standard-making."[142] In that case, a PVC pipe manufacturer sued a steel pipe manufacturer for preventing PVC pipes from inclusion in industry standards.[143] The steel producer had packed the National Fire Protection Association’s annual meeting with members whom the steel manufacturer recruited to defeat the National Electrical Code’s approval of PVC pipes.[144] While the NFPA was a private, voluntary organization, the Supreme Court found that the adoption of its Code by state governments and insurers had an anticompetitive effect.[145] The Supreme Court found it did not matter that the NFPA’s internal rules were not violated or that the steel producer had a genuine belief that PVC pipes were unsafe.[146] In a balancing test called the “Rule of Reason,” the Court held that the anticompetitive effects of the steel producer’s action “outweighed any pro-competitive benefits of standard setting.”[147] It added that such pro-competitive benefits could only exist if the procedures were unbiased.[148]

Like the NFPA in Allied Tube, IDSA’s Lyme panel was packed with members who worked for vaccine, diagnostic, and insurance companies with an economic interest in restraining long-term Lyme care.[149] Had IDSA’s procedures followed its internal rules, packing the panel with biased members would still violate “consensus standard-setting.”[150] Similarly, under the Rule of Reason, the anti-competitive effect of guidelines opposing alternative Lyme treatments outweighs the pro-competitive benefits, which the biased procedures obviate.

Courts hold that antitrust principles apply to professional medical associations.[151] In Wilk v American Medical Ass’n, the seventh circuit found that the American Medical Association violated the Sherman Antitrust Act by labeling chiropractors as “unscientific practitioners” with whom doctors “should not” associate.[152] The court found that the AMA intended to eliminate chiropractics and that it had enough market power to restrain trade because its members were a majority of doctors.[153] Since there were no alleged improprieties in the AMA’s rulemaking process, the court considered that its rule could have pro-competitive benefits when applying the “Rule of Reason.”[154] Such benefits could only exist if the AMA showed that its primary motive for the rule was an “objectively reasonable” concern for patients’ treatment that could not be less restrictively satisfied.[155] However, the court found that there was scientific evidence both for and against chiropractics, and that the AMA didn’t show an educational approach to be less effective than a prohibitive rule.[156] Likewise, even if IDSA’s procedures were unbiased, the guidelines would still lack pro-competitive benefits because the scientific evidence about chronic Lyme is at least mixed, if not confirmatory of its existence.[157] Alternately, if the science really did support IDSA’s position, a less restrictive, educational approach would be more effective in persuading the public than IDSA’s absolutist rule against all long-term treatment. Instead, thousands of patients disbelieve the guidelines and seek treatment for chronic Lyme.[158]

As the Attorney General explains, “Laws protecting competition apply to medical society treatment guidelines… The process producing those guidelines must be fair, inclusive and scientific - untainted, for example, by improper and potentially illegal anticompetitive influence from health insurers and pharmaceutical companies.”[159] The Federal Trade Commission and the Department of Justice say that patient treatment standards are not protected from antitrust actions if insurers collectively refuse to deal with customers whose treatment plans don’t match insurers’ plans.[160] The Attorney General’s investigation revealed that the most powerful insurance companies use IDSA’s guidelines to consistently reject long-term treatment regimens.[161]

Gershon responded to the Attorney General’s conclusions by saying that "no ‘antitrust laws’ were broken… IDSA does not have nor seek monopoly power. We do not work with insurers on any guidelines, nor do we develop our guidelines for the sake of insurers." [162] However, in Allied Tube, the court pointed out “There is no doubt that the members of such associations often have economic incentives to restrain competition.”[163] The stacked members’ economic interests determined the Court’s decision, not any would-be admission that NFPA members opposed PVC pipes for the steel manufacturers’ sake.

While insisting that the guidelines are voluntary, Gershon responded that doctors should not “be allowed to provide unproven therapies to patients for an unproven disease,” and that IDSA’s own recommendations relied “on scientifically rigorous, evidence-based medicine.”[164] Two Georgetown law professors wrote an article criticizing the Attorney General’s action in the Journal of the American Medical Association that took IDSA at its word.[165] They assumed that there is an “absence of benefit from… longterm treatment,” and that “the weight of scientific evidence” favored IDSA.[166] Rather than discuss whether IDSA’s Lyme panel was packed with biased panelists, the authors mistakenly declared that “when a professional organization bases its work on the weight of science there can be no improper restraint of trade.”[167]

However, while the Supreme Court in Allied Tube accepted that the NFPA’s biased members had “a scientific basis for concern” that PVC pipes were unsafe,[168] it affirmed the Second Circuit’s opinion stating: “The ‘objective validity’ of a restraint has never been a defense to an antitrust charge.”[169] Indeed, the Attorney General said: “Our investigation was always about IDSA's guidelines process -- not the science.”[170] A non-biased process using a broad range of evidence and expert consensus is the only method to achieve credible, scientific results.[171]

  1.         The IDSA LYME GUIDELINES REVIEW PANEL

As a result of the investigation, the Attorney General and IDSA agreed that the IDSA would convene a new, unbiased panel to review its Lyme guidelines.[172] The agreement said that Standards and Practice Guidelines Committee (SPGC) would pick a panel chairperson “without any beneficial or financial interest related to Lyme disease, any financial relationship with an entity that has an interest in Lyme disease,” or a published “viewpoint on Lyme disease diagnosis or treatment.”[173] However, the chairperson chosen was former President[174] and current Fellow of IDSA Carol Baker,[175] who served on a “Committee on Infectious Diseases” that published a policy statement:

…the risk of developing late Lyme disease from a recognized deer tick bite that... was not followed by the appearance of erythema migrans is extremely low… Although some physicians obtain a serum sample… for antibody testing to provide reassurance in the absence of erythema migrans and antibiotic therapy, this practice usually is unnecessary… There is a high probability of a false-positive serologic test result for Lyme disease when the probability of the presence of Lyme disease is low.[176]

Another requirement was that the SPGC and chairperson would choose the other panelists, “who [shall], as a group, reflect a balanced variety of perspectives.”[177] However, patient groups complained that IDSA excluded candidates with opposing views, doctors who treated chronic Lyme,[178] and doctors who didn’t treat it, but “were known to have a more open mind.”[179]

  1.         THE REVIEW PANEL’S REPORT

According to the agreement, the panel would conduct a comprehensive review of the scientific literature and public input.[180] The agreement explains:

The principle function of the Review Panel shall be to make an individual determination whether each of the recommendations in the 2006 Lyme guidelines is medically/scientifically justified in light of all of the evidence and information provided… based on its weighing of evidence, the review panel shall recommend one of the following three options… i. That no changes… are necessary. ii. That there is a need for sectional revision… [and] shall make proposals… iii. That a complete rewriting is required.[181] 

Thus, for the panel to recommend an option, it must weigh the evidence, and as part of weighing the evidence, it must vote on the scientific basis.[182] However, the review panel conducted an inconclusive vote on the need to revise the statement “clinical findings alone are not sufficient for diagnosis of extracutaneous manifestations of Lyme… Diagnostic testing… is required for confirmation of extracutaneous Lyme” without voting on this requirement’s scientific basis.[183] Consequently, Attorney General Blumenthal wrote to IDSA in February 2008, objecting to the absence of a vote.[184] Blumenthal added that in its vote on whether to revise the diagnostic requirement panelists were incorrectly given a fourth option: “no change was required with comment.”[185] Indeed, the entire final report was replete with comments and suggested changes, despite its conclusion that “no changes… [were] required.”[186]

Further, the review panel failed to determine that the diagnostic requirement needed no change, because its vote was evenly split and each determination required a supermajority.[187] Blumenthal wrote that the “reasonable conclusion is that half… found that this provision was not supported by the medical/scientific evidence.”[188] Based on its unaccounted-for weighing of the evidence, the panel “suggested” that the guidelines should explicitly deal with patients with “a high prior probability of Lyme disease but equivocal” test results.”[189] The panel reasoned that patients with classic Lyme symptoms in epidemic locations, and for whom alternate diagnoses are unlikely might be an exception to the guidelines’ diagnostic requirement.[190]

Next, the panel voted 7-1 that the guidelines were scientifically justified in stating "there is no convincing biologic evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment regimens."[191] The panel’s only explanation was that the bacteria’s non-active drug-resistant cyst form was not shown to correlate with symptoms.[192] This explanation doesn’t consider whether bacteria could survive in their normal form, say, in organs less penetrable by antibiotics.

The panel also accepted the recommendation that "Antibiotic therapy has not proven to be useful and is not recommended for patients... after recommended treatment regimens for Lyme."[193] The panel used strikingly similar language and reasoning in rejecting controlled studies, saying: "Statistically significant improvements in treatment groups were not demonstrated across studies [ie. different studies have different results], were nonspecific [ie. as the Review panel said: "Symptoms that are commonly attributed to chronic or persistent Lyme, ... are seen in many other clinical conditions and are, in fact, common in the general population."], were of unclear clinical importance…"[194] 

The panel continued: "This conclusion was reached despite the large volume of case reports, case series, anecdotes, and patient testimonials reviewed that attested to perceived clinical improvement during antibiotic therapy. Such evidence is by its nature uncontrolled and highly subject to selection and reporting biases.”[195] Rather than delve into the “comprehensive review” promised in the agreement, the review panel rejected “large volumes of… evidence” because it was level II evidence- like much of the guidelines’ own evidence.[196]  The panel asserted that “prospective, controlled clinical trials for extended antibiotic treatment of Lyme disease have demonstrated considerable risk of harm,” yet it mentioned only "minor adverse events" like diarrhea for oral antibiotics, a common Lyme treatment.[197]  In the face of “the large volume of… evidence” favoring long-term treatment and the panel’s implied admission that the science is mixed ("Statistically significant improvements in treatment groups were not demonstrated across studies”), Wilk holds that IDSA as a professional medical association should not make a rule against long-term treatment.[198]

The Review Panel’s vote on the overall guidelines was particularly strange. The Attorney General related that a vote "on whether... a revision was necessary" to the diagnostic requirement was four to four.[199] Yet "[b]ased on its review of all the evidence and information provided, the Review Panel determined that no changes to the 2006 Lyme disease guideline are necessary at this time (8-0)... Formal recommendations about the utility and appropriate use of alternative tests should be added, with accompanying discussion and references. Such alternative tests should include the following: ...PCR of blood, CSF, and synovial fluid...  Inclusion of the VIsE band in the IgG Western blot…[etc.]"[200] Apparently the review panel believes that the IDSA "should" make significant changes that it considers not "necessary." The vote also means that the one panelist who believes there is “convincing evidence for chronic Lyme” thinks the guidelines do not need to be changed.[201] 

Lyme patients will want to know why panelists voted for guidelines they believe are scientifically unjustified. In a press release, the Lyme Disease Ass’n. “and its 35 associated organizations publicly expressed their concerns about bias in the panel selection” and about the panel’s exclusion of large volumes of research and doctors’ experience.[202] LDA concluded: “The ratification of these guidelines by IDSA becomes another nail in the coffin for those afflicted with Lyme disease.”[203]

Under the agreement, IDSA accepted Connecticut’s jurisdiction over disputes regarding the settlement and that the Attorney General could enforce the agreement as he determines “in his sole discretion is proper and necessary.”[204] Consequently, LDA, Connecticut-based Time for Lyme, the California Lyme Disease Association, and other groups are relying on the Attorney General’s office to enforce the agreement.[205] They ask that members of the public contact the legislators and Attorney Generals of their own states to send letters to IDSA and the CT Attorney General expressing concern and urging compliance with the agreement.[206]

  1.         Conclusion

A disagreement exists in the medical community over Lyme disease.[207] IDSA’s guidelines require an EM rash or positive 2-tier test for diagnosis[208] and deny that Lyme can persist after a 28-day antibiotic treatment.[209] Dissenting doctors accept clinical diagnoses and longer treatments.[210] IDSA’s guidelines are enforced by medical boards and insurers, and adopted by associations like AAN.[211] IDSA’s guidelines are particularly powerful because nearly all neurologists and infectious disease specialists belong to those two associations,[212] just as the AMA’s rules had restraining power in Wilk because the association covered most doctors.[213]

This restraining power is enough for an antitrust action under the “Rule of Reason” in Wilk because either (A) the scientific research is at least mixed, if not confirmatory of the dissenters’ beliefs, or (B) advocates of IDSA’s position have alternatives to setting an absolutist standard that are no less effective.[214] An antitrust action need not rely on Wilk, because procedural biases deprive private associations’ standards of any pro-competitive benefits under Allied Tube, regardless of scientific evidence or alternatives.[215] The Attorney General discovered conflicts of interest among guideline panelists, exclusion of dissenters, and disregard of scientific research.[216] 

IDSA’s review panel suggested clinical discretion for diagnosing Lyme in at-risk areas.[217] But the review panel included panelists with published views on Lyme, excluded candidates with opposing views, rejected large volumes of opposing research, and voted unanimously to accept all the guidelines, despite some panelists’ belief that sections were scientifically unjustified.[218] The Attorney General must demand that IDSA perform an independent, scientific review of its guidelines according to the agreement. He must keep up the same courage and resolve in enforcing the agreement as he has throughout the antitrust action.


[1] Taking Steps toward a Cure for Lyme Disease, Westport News, http://www.westport-news.com/default/article/Taking-steps-toward-a-cure-for-Lyme-disease-447617.php (last visited Apr. 20, 2010).

[2] Robert W. Bradford & Henry W. Allen, Biochemistry of Lyme Disease, Townsend Letter (2006), available at http://www.townsendletter.com/FebMar2006/lyme0206.htm.

[3]Susan Ronn, In the Lymelight: Law and Clinical Practice Guidelines, 102 S. Med. J. 626 (2009).

[4] Id. at 627.

[5] Press Release, Office of Attorney General of Conn., Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter (May 1, 2008), available at http://www.ct.gov/AG/cwp/view.asp?a=2795&q=414284 [hereinafter AG Press Release]

[6] Lorraine Johnson & Ray Stricker, Attorney General Forces Infectious Diseases Society of America to Redo Lyme Guidelines Due to Flawed Development Process, 35 J. Med. Ethics 283–88 (2009); LYME POLICY WONK: CALDA Survey Results Are in!, http://www.lymedisease.org/news/lymepolicywonk/198.html (last visited Jan. 5, 2010).

[7] Johnson, supra note 6.

[8] AG Press Release, supra note 5.

[9] Office of Attorney General of Conn., An Agreement between the Attorney General of the State of Connecticut and the Infectious Diseases Society of America (April 30, 2008), available at http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf [hereinafter Agreement].

[10] Press Release, Lyme Disease Ass’n, Statement of the National Non Profit Lyme Disease Association, Inc. on the IDSA Guidelines Panel Decision (Apr. 22, 2010), available at http://lymediseaseassociation.net/index.php?option=com_content&view=article&id=616:idsa-guidelines-panel-decision-4-22-10&catid=7:conflict-report&Itemid=398. [hereinafter LDA Press Release on Review Report]

[11] Final Report of the Lyme Disease Review Panel of IDSA, IDSA, (Apr. 2010), available at http://www.idsociety.org/Content.aspx?id=16520. [hereinafter IDSA Final Report]

[12] Notice to Readers: Final 2008 Reports of Nationally Notifiable Infectious Diseases, 58 Morbidity & Mortality Wkly. Rep. 856-857; 859-869 (2009), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5831a5.htm.

[13] A.R. 55, 212th Leg., Reg. Sess. (Nj. 2006) (enacted).

[14] Lyme Disease - United States, 2001–2002, 56 Morbidity & Mortality Wkly. Rep. 365–369 (2004), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5317a4.htm [hereinafter Lyme Disease 2004].

[15] DVBID: Transmission | CDC Lyme Disease, http://www.cdc.gov/ncidod/dvbid/LYME/ld_transmission.htm (last visited November 22, 2009).

[16] Bradford, supra note 2.

[17] Lyme Disease - United States, 2003-2005, 56 Morbidity & Mortality Wkly. Rep. 573-576 (2007), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5623a1.htm.

[18] S.B. 1115, 1999 Cal A.L.S. 668 (Ca. 1999) (enacted).

[19] Id; A.R. 55.

[20] Ronn, supra note 3.

[21] Forming the Society: A Look at IDSA’s Foundation, https://www.idsociety.org/Content.aspx?id=9956 (last visited November 22, 2009).

[22] Ronn, supra note 3.

[23] DVBID: Treatment | CDC Lyme Disease, http://www.cdc.gov/ncidod/dvbid/LYME/ld_humandisease_treatment.htm (last visited November 22, 2009).

[24] Wormser G.P., 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. 43 Clinical Infectious Diseases 1089 (2006).

[25] Id. at 1101. A positive DNA (“PCR”) test for the bacteria could alone provide strong evidence of the disease, but the guidelines fail to acknowledge it. Id. at 1110. (“Positive PCR results for a joint fluid specimen from a seronegative patient… should be regarded with skepticism”)

[26] Case Definitions for Infectious Conditions under Public Health Surveillance, 46 Morbidity & Mortality Wkly. Rep. 1-55 (1997), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00047449.htm; UNDER OUR SKIN Blog » Lyme cases spike 77% from 2006 to 2008, http://underourskin.com/blog/?p=337 (last visited November 22, 2009).

[27] Hearing on CDC’s Lyme Disease Prevention and Control Activities before the Conn. Dep’t. of Public Health and the CT AG’s Office (2004) (statement of Paul Mead, CDC Epidemiologist) available at http://www.hhs.gov/asl/testify/t040129.html.

[28] Lyme Disease 2004, supra note 14.

[29] Wormser, supra note 24, at 1101. Its Western Blot criteria requires a positive 5-band IgG test (out of 10 bands) for late-stage Lyme, and a positive 5-band IgG or positive 2-band IgM (out of 3 bands) for early Lyme.

[30] Elizabeth L. Maloney, The Need for Clinical Judgment in the Diagnosis and Treatment of Lyme Disease, 14 J. Am. Physicians & Surgeons, Fall 2009, at 82-83. [hereinafter Maloney, The Need for Clinical Judgment].

[31] Id.

[32] Id.

[33] Wormser, supra note 24, at 1106.

[34] Id. at 1120-1121.

[35] Ira Schwartz et al., Diagnosis of Early Lyme Disease by Polymerase Chain Reaction Amplification and Culture of Skin Biopsies from Erythma Migrans Lesions, 30 J. Clinical Microbiology 3082 (1992).

[36] Wormser, supra note 24, at 1119.

[37] Id. at 1117.        

[38] Id. at 1119 (citing LK Bockenstedt  et al., Detection of Attenuated, Noninfectious Spirochetes in Burgdorferi-infected Mice after Antibiotic Treatment, 15 J. Infectious Diseases 1430 (2002)). They added that the treated, immunosuppressed mice lacked inflammation, yet never said Lyme causes inflammation during immunosuppresion.

[39] Maloney, The Need for Clinical Judgment, supra note 30, at 86.

[40]Wormser, supra note 24, at 1114.

[41] Raphael Stricker & Lorraine Johnson, IDSA Lyme Guidelines: Response to Dr. Gershon’s Letter, 102 S. Med. J. 1089 (2009). [hereinafter Stricker, Response to Gershon]

[42] Evidence-based Guidelines for the Management of Lyme disease. 2 Expert Rev. Anti-Infective Therapy S1, S7 (Supp. I 2004), available at http://www.ilads.org/files/ILADS_Guidelines.pdf. [hereinafter ILADS Guidelines]

[43] Maloney, The Need for Clinical Judgment, supra note 30, at 84, 86.

[44] Id.

[45] Maloney, The Need for Clinical Judgment, supra note 30, at 83.

[46] ILADS Guidelines, supra note 42, at S10.

[47] Id. at S8-S9; Wormser, supra note 24, at 1107.

[48] AG Press Release, supra note 5.

[49] Id.

[50] Wormser, supra note 24, at 1125; Johnson, supra note 6, at 284. (Immunetics, Bio-Rad, Biopeptides, Diaspex, Abbott, Baxter, and Viramed research or produce Lyme diagnostic tests. Baxter, AstraZeneca, Biopeptides, Sanofi-Aventis, GlaxoSmithKline develop Lyme vaccines).

[51] H.M. Feder et al., A Critical Appraisal of ‘‘Chronic Lyme Disease’’, 357 New Eng. J. Med. 1422, 1429 (2007); Johnson, supra note 6, at 284.

[52] Feder, supra note 51; Johnson, supra note 6, at 284.

[53] Johnson, supra note 6, at 284.

[54] Id.

[55] Id.

[56] Id.

[57] Anne Gershon, Unproven Therapies Don't Belong in Lyme Disease Guidelines, 102 S. Med. J. 1088 (2009).

[58] Id.

[59] AG Press Release, supra note 5.

[60] Id.

[61] Id.

[62] Id.

[63] Id.

[64] Mary Ann Kish, Guide to Development of Practice Guidelines, 32 Clinical Infectious Diseases 851 (2001).

[65] AG Press Release, supra note 5.

[66] Id.

[67] Res. 166, New England Governors' Conf. (2002), available at http://www.vermontlyme.org/res166.htm.

[68] AG Press Release, supra note 5.

[69] Id.

[70] Wormser, supra note 24, at 1090.

The U.S. Preventive Services Task Force’s principles for writing its own guidelines say “Recommendations are not based largely on opinion, such as expert opinion.” Agency for Healthcare Research and Quality, Department of Health & Human Services, Pub. No. 08-05118-EF, U.S. Preventive Services Task Force Procedure Manual 51 (2008).

[71] Stricker, Response to Gershon, supra note 41.

[72] Kish, supra note 64, at 853.

[73] Maloney, The Need for Clinical Judgment, supra note 30, at 87.

[74] Wormser, supra note 24, at 1089-1134.

[75] Elizabeth Maloney, Challenge to the Recommendation Restricting Specific Therapeutic

Options in the Treatment of Lyme Disease, http://www.ilads.org/lyme_disease/written_testimony/8%20Maloney-Specific%20Therapeutic%20Options.pdf (last visited February 24, 2010).

[76] Wormser, supra note 24, at 1120.

[77] Gershon, supra note 57.

[78] Stricker, Response to Gershon, supra note 41.

[79] Gershon, supra note 57.

[80] Daniel J. Cameron, Generalizability in Two Clinical Trials of Lyme Disease. 3 Epidemiologic Perspectives & Innovations 12–18 (2006), available at http://www.epi-perspectives.com/content/3/1/12.

[81] Id; Chuck Cooper, Safety of Long-term Therapy with Penicillin and Penicillin Derivatives U.S. Food and Drug Admin. (2009), available at http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm072755.htm.

[82] Kish, supra note 64.

[83] Johnson, supra note 6 at 286.

[84] Wormser, supra note 24, at 1089, 1107.

[85] Johnson, supra note 6 at 286.

[86] AG Press Release, supra note 5.

[87] Id.

[88] Id.

[89] Johnson, supra note 6 at 285.

[90] Id.

[91] Id.

[92] Id. at 285-86.

[93] Id.

[94] Id. at 285.

[95] Thomas-Wilson v. Keystone Health Plan, 1997 WL 27097 (E.D. Pa. Jan. 23, 1997).

[96] Id.

[97] Id.

[98] Johnson, supra note 6, at 285.

[99] Id. at 285-86.

[100] Id. at 285.

[101] Id. at 283.

[102] Id.

[103] Journal of Infectious Diseases, http://www.idsociety.org/Content.aspx?id=9460 (last visited Feb. 26, 2010); Clinical Infectious Diseases, http://www.idsociety.org/Content.aspx?id=9464 (last visited Feb. 26, 2010).

[104] Resources - The American Academy of Neurology, http://patients.aan.com/go/resources (last visited Feb. 26, 2010).

[105] Johnson, supra note 6, at 283.

[106] Departments of Labor, Health, and Human Services, and Education, and Related Agencies Appropriations Act of 2002, Pub. L. No. 107-116, S.1536 (2002).

[107] Ronn, supra note 3, at 628.

[108] Gershon, supra note 57.

[109] Raphael Stricker & Lorraine Johnson, The Infectious Diseases Society of America Lyme Guidelines: Poster Child for Guidelines Reform, 102 S. Med. J. 565 (2009).

[110] Gershon, supra note 57.

[111] Stricker, Response to Gershon, supra note 41.

[112] Id.

[113] Ronn, supra note 3, at 628.

[114] Mark Crane, Doctor Discipline or “Medical McCarthyism”, 78 Med. Econ. 51 (2001)

[115] Id.

[116] Id.

[117] Id; Susan Williams, World Renowned Lyme Disease Doctor Joseph James Burrascano, Jr. Retires, http://www.publichealthalert.org/Articles/susanwilliams/world%20renowned%20doctor%20retires.html (last visited February 25, 2010).

[118] New York State Lyme Disease Controversy, http://www.canlyme.com/nycontroversy.html (last visited February 25, 2010).

[119] Id.

[120] Joseph Burrascano, Admin. Rev. Board Determination & Order No. 01-265 (2002), available at http://www.casewatch.org/board/med/burrascano/order.shtml.

[121] Joseph Burrascano, Off. Prof. Conduct Rev., Determination & Order No. 01-265 (2002), available at http://w3.health.state.ny.us/opmc/factions.nsf/58220x%20%20%20%20a7f9eeaafab85256b180058c032/7f57f08d61de929c85256a4a0047c6da/$FILE/ATTIDOPD/lc145623.pdf.

[122] Anne Krueger, Santee's Dr. Yang: Saint or Sinner?, San Diego Union Trib., Apr. 2, 2005, available at http://www.signonsandiego.com/uniontrib/20050402/news_1m2yang.html.

[123] Id.

[124] Justin J. Simpson, Chapter 304: Broadening the Scope of Alternative and Complementary Medicine to Include Treatment of Persistent Lyme Disease, 37 McGeorge L. Rev. 157, 159 (2006);

[125] Krueger, supra note 122; IDSA’s guidelines admit that Lyme can have neurological symptoms. Wormser, supra note 24, at 1089-1134.

[126] Krueger, supra note 122.

[127] Id.

[128] R.I. Gen Laws § 5-37.5-4.

[129] R.I. Gen Laws § §27-18-62.

[130] Conn. Gen. Stat. §§ 38a-492h (2004). The law requires coverage of 60 days of oral antibiotics and coverage of further treatments prescribed by an “infectious disease specialist,” rheumatologist, or neurologist.

[131] 2005 Cal. Bus & Prof. Code 2005 § 2234.1.

[132] Simpson, supra note 124.

[133] Id. at 160.

[134] Id.

[135] Raphael Stricker & Lorraine Johnson, Chronic Lyme Disease and the "Axis of Evil" 3 Future Microbiology 621-624 (2008). (citing Alan Steere et al., The Overdiagnosis of Lyme Disease 269 J. Am. Med. Ass’n. 1812-1816 (1993)).

[136] A Lyme Disease Warning From The CDC - CBS Evening News, http://www.cbsnews.com/stories/2007/06/17/eveningnews/main2940639.shtml (last visited February 26, 2010).

[137] Tick-Borne Illnesses Underreported, Lack of Provider Awareness Blamed, Med. Utilization Mgmt. June 10, 1999 (citing the CDC as saying that with a weak vaccine in common use, vaccinated patients would be unlikely to report symptoms, further adding to underreporting).

[138] 15 U.S.C.A. § 1 (2006).

[139] See AG Press Release, supra note 5.

[140] Allied Tube & Conduit Corp. v. Indian Head, Inc., 486 U.S. 492, 500 (1988).

[141] Id. at 511.

[142] Indian Head v Allied Tube & Conduit, 817 F.2d 938, 947 (2d Cir. 1987).

[143] Allied Tube, 486 U.S. at 492.

[144] Id.

[145] Id. at 492, 496.

[146] Id. at 497-98.

[147] Id. at 497-98.

[148] Id. at 501.

[149] AG Press Release, supra note 5.

[150] Indian Head, 817 F.2d at 947.

[151] Arizona v. Maricopa County Med. Soc'y, 457 U.S. 332 (1982).

[152] Wilk v. AMA, 895 F2d 352, 355 (7th Cir 1990).

[153] Id. at 359.

[154] Id. at 362.

[155] Id.

[156] Id.

[157] Cameron, supra note 80.

[158] Simpson, supra note 124, at 160.

[159]Richard Blumenthal, Conflicts of Interest in Treatment Guidelines, Day, July 19, 2009, available at http://lindaslymediseasejournal.blogspot.com/2009/07/conflicts-of-interest-in-idsa-treatment.html.

[160] Fed. Trade. Comm’n & Dep't. of Justice, 4. Statement of Department of Justice and Federal Trade Commission Enforcement Policy on Providers’ Collective Provision of Non-Fee-Related Information to Purchasers of Health Care Services (1996), available at http://www.ftc.gov/bc/healthcareindustryguide/policy/statement4.htm.

[161] AG Press Release, supra note 5.

[162] Gershon, supra note 57.

[163] Allied Tube, 486 U.S. at 500.

[164] Gershon, supra note 57.

[165] John Kraemer & Lawrence Gostin, Science, Politics, and Values: The Politicization of Professional Practice Guidelines, 301 J. Am. Med. Ass'n 665-66 (2009), available at http://scholarship.law.georgetown.edu/cgi/viewcontent.cgi?article=1019&context=ois_papers.

[166] Id.

[167] Id. They used the Rule of Reason test to claim the guidelines’ “substantial” patient benefits outweighed the anti-competitive effects, but failed to mention that procedural flaws erase those benefits. Allied Tube, 486 U.S. at 501.

[168] Allied Tube, 486 U.S. at 496.

[169] Indian Head, 817 F.2d at 947.

[170] AG Press Release, supra note 5.

[171] Richard Wolfram, Connecticut Attorney General Investigation and Settlement Highlights Possible Applicability of Antitrust Standard Setting Law to the Development of Clinical Practice Guidelines, 23 Antitrust Health Care Chron. 8, 13 (2008), available at http://new.abanet.org/antitrust/Searchable%20Antitrust%20Library/Antitrust%20Health%20Care%20Chronicle-October%2020081.pdf.

[172] AG Press Release, supra note 5.

[173] Agreement, supra note 9.

[174] LDA Press Release on Review Report, supra note 10.

[175] Texas Children's Hospital, Credentials for Carol J. Baker, M.D., http://www.texaschildrens.org/findadoctor/displaybio.asp?person_id=141 (last visited Apr. 27, 2010).

[176] American Academy of Pediatrics, Prevention of Lyme Disease, 105 Pediatrics 142, 142-47 (2000), available at http://aappolicy.aappublications.org/cgi/reprint/pediatrics;105/1/142.pdf.

[177] Agreement, supra note 9.

[178] Press Release, Lyme Disease Ass’n, IDSA Violates Settlement Agreement Voting Procedures (Feb. 4, 2010), available at http://www.lymediseaseassociation.org/NewsReleases/20100204.html. [hereinafter LDA Press Release on Voting]

[179] LYMEPOLICYWONK: IDSA and Lyme Hearings: TOP 10 Count Down for the Masters of Manipulation?, http://www.lymedisease.org/news/lymepolicywonk/368.html (last visited Apr. 27, 2010).

[180] Agreement, supra note 9.

[181] Id.

[182] See Id.

[183] IDSA Final Report, supra note 11. While the diagnostic requirement was not in the “recommendations” sections, it not only recommends, but requires certain procedures. If this is not in fact a recommendation, then the guidelines lack a diagnostic recommendation-- a deficiency the review panel should have corrected.

[184] Letter from Richard Blumenthal, Ct. Attorney General, to Richard Whitley, IDSA president (Feb 1. 2009), available at http://www.lymedisease.org/news/files.php?file=Blog_attachment_IDSA_672928991.pdf.

[185] Id.

[186] IDSA Final Report, supra note 11.

[187] Agreement, supra note 9; Letter from Richard Blumenthal, supra note 184.

[188] Letter from Richard Blumenthal, supra note 184.

[189] IDSA Final Report, supra note 11.

[190] Id.

[191] Id.

[192] Id.

[193] Id.

[194] Id; Cf. Wormser, supra note 24, at 1116 (“a minority of patients with Lyme disease will be symptomatic following a recommended  course of antibiotic treatment… as a result of a variety of other factors, such as the high frequency of identical complaints in the general population.”), 1118 (discounting the “clinical significance” of cyst forms). The guidelines use the word “nonspecific” 6 times to discount persistent Lyme.

[195] IDSA Final Report, supra note 11.

[196] Id. The detailed explanation was that in “many published case reports” patients were abnormal, or weren’t subject to the guidelines’ diagnostic requirements or treatment. This simply means the studies were uncontrolled. Results could have been compared to studies where patients underwent short-term treatment, instead of disregarded.

[197] Id.

[198] Id; Wilk, 895 F2d at 362.

[199] Letter from Richard Blumenthal, supra note 184.

[200] IDSA Final Report, supra note 11.

[201] See Id.

[202] LDA Press Release on Review Report, supra note 10.

[203] Id.

[204] Agreement, supra note 9.

[205] POLITICAL ACTION: Make your voice heard with AGs across the country, http://www.lymedisease.org/news/lyme_action_alerts/337.html (last visited Apr. 20, 2010).

[206] Id; LYMEPOLICYWONK: IDSA APRIL DEADLINE, http://www.lymedisease.org/news/lymepolicywonk/390.html (last visited Apr. 20, 2010).

[207] Ronn, supra note 3.

[208] Wormser, supra note 24, at 1101.

[209] Id. at 1107.

[210] ILADS Guidelines, supra note 42, at S7, S10.

[211] Johnson, supra note 6, at 283, 286.

[212] Membership Growth - American Academy of Neurology, http://www.aan.com/go/about/statistics (last visited Mar. 12, 2010); Matthew Menken, Generalism and Specialism Revisited: The Case of Neurology, 7 Health Affairs 115, 118 (1983), available at http://content.healthaffairs.org/cgi/reprint/7/5/115.pdf; Cf. Claudia Kalb, Lyme Time in DC, The Human Condition Blog, Newsweek, http://blog.newsweek.com/blogs/thehumancondition/archive/2009/07/30/lyme-time-in-dc-unravelling-how-to-best-treat-the-disease.aspx (last visited March 12, 2010); American Board of Medicine, Candidates Certified, http://www.abim.org/pdf/data-candidates-certified/all-candidates.pdf (last visited Mar. 12, 2010).

[213] Wilk, 895 F2d at 360.

[214] Id. at 362.

[215] Allied Tube, 486 U.S. at 497-98, 501.

[216] AG Press Release, supra note 5.

[217] IDSA Final Report, supra note 11.

[218] See Id.