1 Ferguson, Johanna, Note, Cure Unwanted? Exploring the Chronic Lyme Disease Controversy and Why Conflicts of Interest in Practice Guidelines May Be Guiding Us Down the Wrong Path, 38 AM. J.L. & MED. 196 (2012).Google ScholarPubMed

2 Slama, Thomas G., Letter to the Editor, 38 AM. J.L. & MED. 742 (2012).CrossRefGoogle Scholar

3 See, e.g., COMM. ON CLINICAL PRACTICE GUIDELINES, INST. OF MED., GUIDELINES FOR CLINICAL PRACTICE 16 (Marilyn J. Field & Kathleen N. Lohr eds., 1992); Parker, Christine W., Practice Guidelines and Private Insurers, 23 J.L. MED. & ETHICS 57, 57-58 (1995)CrossRefGoogle ScholarPubMed; Steinbrook, Robert, Guidance for Guidelines, 356 NEW ENG. J. MED. 331, 331 (2007)CrossRefGoogle ScholarPubMed; Jackson, Douglas W., Clinical Guidelines: Beware, What Are Suggestions Will Become Mandates, HEALIO.COM (Mar. 2010), http://www.healio.com/orthopedics/business-of-orthopedics/news/print/orthopedics-today/%7B197c651b-381f-4fe6-9b18-5150ee2d46c6%7D/clinical-guidelines-beware-what-are-suggestions-will-becomemandatesGoogle Scholar; see also, e.g., Cigna Medical Coverage Policy: Lyme Disease Treatment, CIGNA, http://www.cigna.com/assets/docs/health-care-professionals/coverage_positions/mm_0400_coveragepositioncriteria_lyme_disease_treatment.pdf (last updated Aug. 15, 2012) (discussing coverage for Lyme disease, including a reference to the IDSA's 2006 guidelines)Google Scholar; Clinical Policy Bulletin: Lyme Disease and Other Tick-Borne Diseases, AETNA, http://www.aetna.com/cpb/medical/data/200_299/0215.html (last updated May 25, 2012) (discussing coverage for Lyme disease, including a reference to the IDSA's 2006 guidelines).Google Scholar

4 See Hearing on the Lyme and Related Tick-Borne Disease Education, Prevention, and Treatment Act Before the Health & Human Servs. Comm., 2007 Leg. (Pa. 2007) (statement of Michael Buckley & John D. Goldman, Members, Infectious Disease Society of America), available at http://www.legis.state.pa.us/cfdocs/legis/TR/transcripts/2007_0227_0003_TSTMNY.pdf; GOVERNOR's TASK FORCE ON LYME DISEASE, COMMONWEALTH OF VA., FINAL REPORT 3 (2011), available at http://wolf.house.gov/uploads/Report_of_the_Virginia_Task_Force_on_Lyme_Disease_Final.pdf; Letter from Anne A. Gershon, President, Infectious Diseases Soc’y of Am., to Henry Waxman, Chairman, H. Energy & Commerce Comm. (June 25, 2009), available at http://www.idsociety.org/uploadedFiles/IDSA/Topics_of_Interest/Lyme_Disease/Policy_Documents/IDSA%20HR%201179%20Letter%20to%20US%20House%20of%20Representatives%20062509.pdf; Letter from James Hughes, President, Infectious Diseases Soc’y of Am., to Jeb Bradley, Chair, N.H. State Senate Health & Human Servs. Comm. (Apr. 5, 2011), available at http://www.idsociety.org/uploadedFiles/IDSA/Topics_of_Interest/Lyme_Disease/Policy_Documents/Lyme%20disease_Legislative_Letter_NH_Bradley_%204-05-2011.pdf; Statement for the House Foreign Affairs Committee: Africa, Global Health and Human Rights Subcommittee's Hearing on Global Challenges in Diagnosing and Managing Lyme Disease—Closing Knowledge Gaps, INFECTIOUS DISEASES SOC’Y OF AM. (July 17, 2012), http://www.idsociety.org/uploadedFiles/IDSA/Topics_of_Interest/Lyme_Disease/Policy_Documents/Lyme%20Disease%20Testimony-Global%20Health%20Subcommittee.pdf.

5 See, e.g., Letter from James Hughes to Jeb Bradley, supra note 4, at 1.

6 See Slama, supra note 2.

7 See id. at 742 nn.3-4, 743 nn.6-7. See also, e.g., Auwaerter, Paul G. et al., Antiscience and Ethical Concerns Associated with Advocacy of Lyme Disease, 11 LANCET INFECTIOUS DISEASES 713 (2011) [hereinafter Auwarter et al., Antiscience]CrossRefGoogle ScholarPubMed; Auwaerter, Paul G. et al., Scientific Evidence and Best Patient Care Practices Should Guide the Ethics of Lyme Disease Activism, 37 J. MED. ETHICS 68 (2011) [hereinafter Auwaerter et al., Scientific Evidence]CrossRefGoogle ScholarPubMed; Dattwyler, Raymond J. et al., A Comparison of Two Treatment Regimens of Ceftriaxone in Late Lyme Disease, 117 WIENER KLINISCHE WOCHENSCHRIFT 393 (2005) (Austria)CrossRefGoogle ScholarPubMed; Feder, Henry M. Jr., et al., A Critical Appraisal of “Chronic Lyme Disease,” 357 NEW ENG. J. MED. 1422 (2007)CrossRefGoogle Scholar; Klempner, Mark S. et al., Two Controlled Trials of Antibiotic Treatment in Patients with Persistent Symptoms and a History of Lyme Disease, 345 NEW ENG. J. MED. 85 (2001)CrossRefGoogle Scholar; Krupp, L.B. et al., Study and Treatment of Post Lyme Disease (STOP-LD): A Randomized Double Masked Clinical Trial, 60 NEUROLOGY 1923 (2003)CrossRefGoogle ScholarPubMed; Patel, Robin et al., Brief Report, Death from Inappropriate Therapy for Lyme Disease, 31 CLINICAL INFECTIOUS DISEASES 1107 (2000)CrossRefGoogle ScholarPubMed; Wormser, Gary P. et al., Duration of Antibiotic Therapy for Early Lyme Disease: A Randomized, Double-Blind, Placebo-Controlled Trial, 138 ANNALS INTERNAL MED. 697 (2003) [hereinafter Wormser et al., Duration].CrossRefGoogle ScholarPubMed For a list of the authors of the 2006 IDSA Lyme guidelines, see Wormser, Gary 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) [hereinafter Wormser et al., The Clinical Assessment].CrossRefGoogle ScholarPubMed For information on the IDSA's Clinical Infectious Diseases publication, see Clinical Infectious Diseases, OXFORD JOURNALS http://www.oxfordjournals.org/our_journals/cid/about.html (last visited Nov. 29, 2012).

8 See Slama, supra note 2, at 743 n.6; see also Auwaerter et al., Scientific Evidence, supra note 7; Wormser et al., Duration, supra note 7.

9 See, e.g., Clinical Immunology, Allergy and Rheumatology, N.Y. MED. COLL., http://www.nymc.edu/depthome/academic/medicine/immunology.html (last visited Sept. 20, 2012) (indicating that Raymond Dattwyler, co-author of the IDSA's 2006 guidelines, has connections to Lyme diagnostic tests); Lyme Disease Test Eliminates Long Wait, READING EAGLE, Sept. 10, 2001, at A6, available at http://news.google.com/newspapers?nid=1955&dat=20010910&id=SlsxAAAAIBAJ&sjid=36IFAAAAIBAJ&pg=5097,6222671 (same). While it is true that the IDSA's 2006 Lyme Guidelines do not recommend a specific Lyme diagnostic test, the guidelines do recommend testing “using the 2-tier testing algorithm recommended by the Centers for Disease Control and Prevention.” Wormser et al., The Clinical Assessment, supra note 7, at 1101. The Centers for Disease Control and Prevention (CDC), is an organization with which the IDSA has close ties. See, e.g., Am. Thoracic Soc’y et al., Treatment of Tuberculosis, 167 AM. J. RESPIRATORY & CRITICAL CARE MED. 603 (2003)CrossRefGoogle Scholar; Dykewicz, Clare A., Summary of the Guidelines for Preventing Opportunistic Infections Among Hematopoietic Stem Cell Transplant Recipients, 33 CLINICAL INFECTIOUS DISEASES 139 (2001) (summarizing guidelines promulgated by the CDC and IDSA)CrossRefGoogle ScholarPubMed. The CDC specifically indicates that two-tiered blood testing is the recommended method for Lyme diagnosis. CTRS. FOR DISEASE CONTROL & PREVENTION, LYME DISEASE: A PUBLIC INFORMATION GUIDE (2007), available at http://www.cdc.gov/ncidod/dvbid/lyme/lyme_brochure.pdf. The New York Times reported that the CDC “recommends only these tests.” Lyme Disease: Diagnosis, N.Y. TIMES HEALTH GUIDE, http://health.nytimes.com/health/guides/disease/lyme-disease/diagnosis.html (including PreVue as a recommended test) (last reviewed Jan. 13, 2011); see also Lyme Disease and Related Tick-Borne Infections—Diagnosis, UNIV. OF MD. MED. CTR., http://www.umm.edu/patiented/articles/how_lyme_disease_diagnosed_000016_6.htm (last reviewed Feb. 11, 2009). PreVue, the test with which one member of the 2006 guideline panel was connected, complied with this system of two-tiered testing. PreVue B. Burgdorferi, CLIAWAIVED.COM, http://www.cliawaived.com/web/items/pdf/INV-63220_PreVue_B_Burgdorferi~1098file2.pdf (last visited Sept. 29, 2012) (noting that PreVue test results should be confirmed with a Western Blot). This testing structure excludes alternative testing methods which are suggested for use by organizations that oppose the IDSA's Lyme guidelines. See, e.g., Presented by Igenex, Inc., What You Should Know About Lyme Disease, INT’L LYME & ASSOCIATED DISEASES SOC’Y (July 2002), http://www.ilads.org/lyme_research/lyme_articles6.html.

10 See Stefanie Ramp & Jen Darr, Tick Tick, PHILA. CITY PAPER, (July 8-15, 1999), http://archives.citypaper.net/articles/070899/feat.cov1.shtml; see also John Gever, Activists Force Review of Lyme Disease Guidelines, MEDPAGETODAY (July 11, 2008) http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/10092.

11 See, e.g., Auwaerter et al., Antiscience, supra note 7, at 717 (disclosing conflicts such as providing expert testimony in medicolegal suits and malpractice litigation, investments in drug companies and ownership of patents in connection with Lyme disease); Wormser, Gary P. et al., The Amber Theory of Lyme Arthritis: Initial Description and Clinical Implications, 31 CLINICAL RHEUMATOLOGY 989, 993 (2012) (disclosing conflicts such as expert witness testimony and research grants).CrossRefGoogle ScholarPubMed