1 W. Bruce Fye, President, American College of Cardiology, The Power of Clinical Trials and Guidelines, and the Challenge of Conflicts of Interest, Presidential Address before the Mayo Clinic, Division of Cardiovascular Diseases (Apr. 16, 2003), in 41 J. AM. COLL. CARDIOLOGY 1237 (2003).

2 Gary P. Wormser 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). See also An Agreement Between the Attorney General of the State of Connecticut and the Infectious Diseases Society of America 1 (April 30, 2008), available at http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf.

3 Monique C.M. Leahy, Negligent Diagnosis and Treatment of Lyme Disease, 113 AM. JUR. TRIALS 421 (2010).

4 Id.

5 Lori Aratani, Getting Serious on Lyme, WASH. POST, June 17, 2008, at HE01.

6 Press Release, Conn. Att’y Gen.'s Office, 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.

7 Id.

8 See PAMELA WEINTRAUB, CURE UNKNOWN: INSIDE THE LYME EPIDEMIC 350 (2008).

9 WEINTRAUB, supra note 8; Press Release, Conn. Att’y Gen.'s Office, supra note 6.

10 Kathleen N. Lohr, Guidelines for Clinical Practice: What They Are and Why They Count, 23 J.L. MED. & ETHICS 49, 50 (1995).

11 See Christine W. Parker, Practice Guidelines and Private Insurers, 23 J.L. MED. & ETHICS 57, 57 (1995).

12 See generally Mark A. Hall & Carl E. Schneider, Patients as Consumers: Courts, Contracts, and the New Medical Marketplace, 106 MICH. L. REV. 643, 645, 646, 652-53, 659 (2008).

13 See id. at 652.

14 See id. at 653 (quoting THOMAS E. GETZEN, HEALTH ECONOMICS 114 (2007)) (“Unlike a person shopping for a car, a suit or a haircut, the medical patient does not know what it is they [sic] need, what it should cost, or even, once paid for, how much good the treatment really did. Instead of a clear specification of what is to be expected from both parties, the patient must trust the doctor to do what is right and to bill fairly for the necessary care.”).

15 See id. at 652, 653.

16 Learn about Lyme Disease, CTRS. FOR DISEASE CONTROL & PREVENTION, http://www.cdc.gov/ncidod/dvbid/lyme/index.htm (last visited Dec. 31, 2011).

17 WEINTRAUB, supra note 8, at 5; Aratani, supra note 5, at HE01 (noting that the number of Lyme cases in Virginia tripled from 2006 to 2007; cases also more than doubled in Maryland and nearly doubled in the District of Columbia).

18 Learn about Lyme Disease, supra note 16.

19 Id.

20 See generally Wormser et al., supra note 2.

21 See WEINTRAUB, supra note 8, at xvi.

22 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, 158-59 (2006).

23 Id. at 159; Basic Information about Lyme Disease, INT’L LYME & ASSOCIATED DISEASES SOC’Y, http://www.ilads.org/lyme_disease/about_lyme1.html (last visited Dec. 31, 2011). The International Lyme and Associated Diseases Society suggests that patients suffering from chronic Lyme disease should be treated until their symptoms are eradicated. INT’L LYME & ASSOCIATED DISEASES SOC’Y, supra. This may necessitate treatment periods as long as six months. Rusty Unger, Germ Warfare, N.Y. MAG., Feb. 28, 2000, at 22.

24 See Unger, supra note 23. Specifically, critics of chronic Lyme believe the symptoms are “a lingering set of autoimmune symptoms triggered by the original, defunct infection.” Id.

25 WEINTRAUB, supra note 8, at xv, 49.

26 Id. at 44, 49.

27 See id.

28 Id. at 49.

29 Id. at xv.

30 Id. at 50.

31 See id. at 50-51. Steere's infamous role as Lyme's initial researcher is one of several conflicts of interest to mar the disease's history. Weintraub, in particular, noted of Steere's early work that, “[t]he risk that a researcher might unwittingly impose his or her personal worldview or training on a system under study, thus biasing experiments and influencing the outcome without quite realizing it, had occurred. Not only did [Steere] view a multisystem illness through the prism of rheumatology, [he] also failed to factor in a hundred years of research from Europe … .” Id. at 53.

32 Id. at 50.

33 Id. at 80-87. By the time Burgdorfer made his discovery, the National Institutes of Health (NIH) had already decided that funding for Lyme research would come from its arthritis branch. Unger, supra note 23. Those who study Lyme as an infectious disease maintain that it is difficult to receive NIH funding for this purpose. Id.

34 WEINTRAUB, supra note 8, at 91.

35 Id.

36 Id.

37 Id.

38 Id. at 92.

39 Id.

40 Allen C. Steere et al., Treatment of the Early Manifestations of Lyme Disease, 99 ANNALS OF INTERNAL MED. 22, 26 (1983).

41 WEINTRAUB, supra note 8, at 89-90.

42 Id.

43 Id. at 90, 93, 101.

44 Id. at 82, 89-90, 95, 104.

45 Id. at 102-04.

46 The IDSA, for instance, has issued practice guidelines on topics ranging from pneumonia, Lionell A. Mandell et al., Infectious Diseases Society of America / American Thorasic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults, 44 CLINICAL INFECTIOUS DISEASES S27 (Supp. 2007), to diabetic foot infections, Benjamin A. Lipsky et al., Diagnosis and Treatment of Diabetic Foot Infections, 39 CLINICAL INFECTIOUS DISEASES 885 (2004).

47 Press Release, Conn. Att’y Gen.'s Office, supra note 6.

48 Lohr, supra note 10, at 49. Although practice guidelines go by many names, for instance the American Medical Association refers to them as practice parameters, all such titles refer to a standardized way of treating patients. Id.

49 Lars Noah, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 ARIZ. L. REV. 373, 417 (2002).

50 Id. at 416-18.

51 See id. at 418-19.

52 Lohr, supra note 10, at 51.

53 See id. at 51-52.

54 See id. at 51.

55 See id.

56 Kathleen N. Lohr, RTI INT’L, http://www.rti.org/page.cfm?objectid=0D1A2769-6C25-4022-8A52EFBBD642F288 (last visited Dec. 31, 2011).

57 Lohr, supra note 10, at 51.

58 Ronan Avraham, Clinical Practice Guidelines: The Warped Incentives in the U.S. Healthcare System, 37 AM. J.L. & MED. 7, 30 (2011). Avraham notes that certain incentives, such as cost containment and avoidance of liability, are inappropriate in guideline development. Id. When such incentives are the driving force behind guidelines, then the guidelines themselves are not “optimal,” and therefore physicians who use them are not providing optimal care. Id.

59 Lohr, supra note 10, at 51-52.

60 Robert L. Kane, Creating Practice Guidelines: The Dangers of Over-Reliance on Expert Judgment, 23 J.L. MED. & ETHICS 62, 63 (1995).

61 Lohr, supra note 10, at 49-50.

62 See Evidence-Based Healthcare and Systematic Reviews, THE COCHRANE COLLABORATION, http://www.cochrane.org/about-us/evidence-based-health-care (last visited Dec. 31, 2011); Eugene R. Waclawski & Ira Maden, Editorial in the Current Era of Evidence-Based Guidelines, Do Consent Based Guidelines Still Have a Place?, 55 OCCUPATIONAL MED. 344, 344 (2005). The Cochrane Collaboration strives to assist healthcare providers with their practices by providing treatment guidelines that reflect evidence acquired through research. See About Us, THE COCHRANE COLLABORATION, http://www.cochrane.org/about-us (last visited Dec. 31, 2011). The Cochrane Collaboration describes its practice of guideline promulgation as a “conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” Evidence-Based Healthcare and Systematic Reviews, supra. The Cochrane Collaboration's processes are contrasted by guidelines that result from consensuses reached by panels of experts. See Waclawski & Maden, supra.

63 Matthew K. Wynia, The Role of Professionalism and Self-Regulation in Detecting Impaired or Incompetent Physicians, 304 JAMA 210, 210 (2010).

64 See generally Kane, supra note 60.

65 See Noah, supra note 49, at 385 (noting that a recent study found that heart catheterization for purposes of monitoring a patient during surgery, a practice which had become routine over the past thirty years, has no actual benefit and may even be harmful).

66 See Parker, supra note 11, at 60.

67 Kane, supra note 60, at 63-64.

68 Jodi Halpern, Can the Development of Practice Guidelines Safeguard Patient Values?, 23 J.L. MED. & ETHICS 75, 75 (1995). Halpern suggests that certain treatments, such as hysterectomies for abnormal uterine bleeding and cataract surgeries for people with dementia, are examples of this. While these procedures might not be medically necessary, patients may see them as beneficial. See also Lohr, supra note 10, at 51 (noting that the Institute of Medicine has suggested that having nonphysicians or patient representatives on guideline panels would likely benefit the process by providing different perspectives). Those suffering from chronic Lyme disease have felt that their values in particular have been disregarded. Patients who sought to be involved in the IDSA's guideline process were explicitly prevented from doing so. Lorraine Johnson & Raphael B. Stricker, Attorney General Forces Infectious Diseases Society of America to Redo Lyme Guidelines Due to Flawed Development Process, 35 J. MED. ETHICS 283, 284 (2009).

69 Lohr, supra note 10, at 50.

70 See id. There are thousands of guidelines in existence today, promulgated by various entities. Id. It is of no surprise then that different groups may often reach different results and have different success rates when developing guidelines on a particular subject matter. See Waclawski & Maden, supra note 62.

71 See U.S. Health Care Costs: Background Brief, KAISEREDU.ORG, http://www.kaiseredu.org/Issue-Modules/US-Health-Care-Costs/Background-Brief.aspx (last visited Dec. 31, 2011)

72 Id.

73 See Parker, supra note 11.

74 See id.

75 See id. at 57 (noting that in 1991, Medicare paid for a large number of tests that at that time were considered to be without medical merit by the College of American Pathologists). Contra id. (noting that medical procedures that are not covered by insurance but which may be medically necessary, for instance neonatal care or immunizations, are often not performed in underinsured areas).

76 Parker, supra note 11, at 57-58.

77 Wynia, supra note 63, at 210.

78 Id. It is well documented that peer review does not function efficiently. See Editorial, Can Physicians Regulate Themselves?, 172 CANADIAN MED. ASS’N J. 717, 717 (2005); Ronald L. Goldman, The Reliability of Peer Assessments of Quality Care, 267 JAMA 958, 958-59 (1992); Bruce E. Landon et al., Physician Clinical Performance Assessment, 290 JAMA 1118, 1119 (2003); Maureen A. Smith et al., Peer Review of the Quality of Care Reliability and Sources of Variability for Outcome and Process Assessments, 278 JAMA 1573, 1573, 1577-78 (1997). See generally Fred MacD. Richardson, Peer Review of Medical Care, 10 MED. CARE 29 (1972).

79 See Wynia, supra note 63, at 210-11.

80 See id.

81 See id.

82 See Johnson & Stricker, supra note 68, at 285.

83 CONGRESSIONAL BUDGET OFFICE, Limiting Tort Liability for Medical Malpractice (Jan. 8, 2004), available at http://www.cbo.gov/ftpdocs/49xx/doc4968/01-08-MedicalMalpractice.pdf.

84 Id.

85 Troyen A. Brennan, Practice Guidelines and Malpractice Litigation: Collision or Cohesion?, 16 J. HEALTH POL. POL’Y & L. 67, 68 (1991).

86 See id. at 73. There may be confusion over a standard of care for multiple reasons. Courts may find that competing guidelines conflict with one another or they may simply feel unable to make informed decisions due to a lack of in-depth knowledge on the medical subject matter. See Avraham, Clinical Practice Guidelines, supra note 58, at 14; Steven Woolf et al., Potential Benefits, Limitations, and Harms of Clinical Guidelines, 318 BRIT. MED. J. 527, 530 (2009).

87 Avraham, Clinical Practice Guidelines, supra note 58, at 14.

88 Id.

89 Id. at 14-15.

90 See Brennan, supra note 85, at 73.

91 See Kane, supra note 60.

92 Parker, supra note 11. See also Press Release, Conn. Att’y Gen.'s Office, supra note 6 (noting that several healthcare insurers used guidelines to refuse reimbursement for certain treatments).

93 McClellan v. Health Maint. Org., 660 A.2d 97 (Pa. Super. Ct. 1995); Dukes v. U.S. Healthcare, Inc., 57 F.3d 350 (3d Cir. 1995).

94 See Parker, supra note 11.

95 Id. at 58.

96 See Avraham, Clinical Practice Guidelines, supra note 58, at 8-9.

97 See Parker, supra note 11.

98 Id. at 58. At least one author has expressed discomfort with using guidelines as a means to track and evaluate physicians, noting that “because guidelines are designed to function as patient care guides and not as physician performance measures, many have expressed concern about the appropriateness of using guidelines for this purpose.” Alisa M. Shea et al., Use and Perceptions of Clinical Practice Guidelines, 22 AM. J. MED. QUALITY 170, 170 (2007).

99 Avraham, Clinical Practice Guidelines, supra note 58, at 28.

100 Lohr, supra note 10, at 51.

101 Id. at 52.

102 Id. at 53 (noting that about four percent of all health services scientific evidence is strong).

103 Id.

104 Id.

105 Pierluigi Tricoci et al., Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines, 301 JAMA 831, 837 (2009). It is especially common to find differing guidelines on subjects for which there is limited or conflicted information. Id.

106 Lohr, supra note 10, at 53

107 Terrence M. Shaneyfelt & Robert M. Centor, Reassessment of Clinical Practice Guidelines: Go Gently into that Good Night, 301 JAMA 868, 868 (2009).

108 Ronan Avraham, Private and Competitive Regulation of Medicine, 6 ECONOMIST VOICE 1, 2 (2009). Research has shown that it can take up to seventeen years for quality medical research to have an effective voice through practice guidelines. Avraham, Clinical Practice Guidelines, supra note 58, at 15. Because of this delay, and changing medical knowledge and science, guidelines may be completely obsolete by the time they reach the public domain. Id. at 29.

109 See Shaneyfelt & Centor, supra note 107.

110 Avraham, Clinical Practice Guidelines, supra note 58, at 29.

111 Id.

112 Tricoci et al., supra note 105, at 835.

113 See Johnson & Stricker, supra note 68, at 286 (noting that the IDSA's Lyme guidelines were treated with the force of law by medical boards and insurers).

114 The IDSA itself notes:

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to the guidelines listed below to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.

Standards, Practice Guidelines, and Statements Developed and / or Endorsed by IDSA, INFECTIOUS DISEASES SOC’Y OF AM., http://www.idsociety.org/Guidelines_Patient_Care/ (last visited Feb. 20, 2011).

115 Shaneyfelt & Centor, supra note 107, at 869.

116 Shea et al., supra note 98, at 170.

117 See Press Release, Conn. Att’y Gen.'s Office, supra note 6.

118 Fye, supra note 1.

119 Id.

120 WEINTRAUB, supra note 8, at 199.

121 Id.

122 Id.; see Proceedings of the Second National Conference on Serologic Diagnosis of Lyme Disease (Oct. 27-29, 1994), available at http://viralab.us/Dearborn-2nd%20Nat.%20Conf.%20on%20Serologic%20Diagnosis%20of%20Lyme%20Recommendations.pdf; see also ILADS’ Position Paper on the CDC's Statement Regarding Lyme Disease, INT’L LYME & ASSOCIATED DISEASES SOC’Y, http://www.ilads.org/about_ILADS/position_papers3.html (last visited Dec. 31, 2011).

123 Proceedings of the Second National Conference on Serologic Diagnosis of Lyme Disease, supra note 122.

124 See Elizabeth L. Maloney, Serologic Testing in Lyme Disease, MINN. LYME ASS’N, http://mnlyme.com/files/Serologic_Testing_in_Lyme_Disease2.pdf (last visited Dec. 31, 2011).

125 See Unger, supra note 23.

126 Frank Dressler et al., Western Blotting in the Serodiagnosis of Lyme Disease, 167 J. INFECTIOUS DISEASES 392, 392 (1993). Interestingly enough, Steere was the only author listed who failed to disclose any affiliations. Id.

127 WEINTRAUB, supra note 8, at 200.

128 Id.

129 Id.

130 Id.

131 Id. at 201.

132 Id.

133 Id.

134 Id.

135 Patients who were immunized with these Lyme vaccines would test positive for OspA—a fact relied upon by Dearborn scientists as justification for refusing to include OspA in diagnostic tests. See Maloney, supra note 124. Positive OspA results in individuals who had not been vaccinated, however, is “highly indicative of exposure” to Lyme. Id. Both vaccines have since been pulled from the market due to their tendency to cause debilitating side effects in those who received them. Johnson & Stricker, supra note 68. See generally, WEINTRAUB, supra note 8, at 309-19. After completing his vaccination trials, Steere at one point acknowledged the possibility that OspA caused chronic Lyme. This did not prevent his endorsement of the vaccine, nor did it prevent the FDA from approving the vaccine for use. WEINTRAUB, supra note 8, at 311-12.

136 WEINTRAUB, supra note 8, at 309-10.

137 Id. at 310.

138 Id. at 311.

139 Id. at 315.

140 Id. Steere and the other individuals involved with the vaccine were not the only ones who stood to profit. Several government agencies, including the CDC and the NIH, owned rights to revenue for more than one-third of the U.S. patents that were relevant to Lyme vaccines and tests. Id.

141 Johnson & Stricker, supra note 68, at 283. Time for Lyme is a Connecticut-based group. Id.

142 WEINTRAUB, supra note 8, at 350.

143 Jerome P. Kassirer, Why Should We Swallow What These Studies Say?, WASH. POST, Aug. 1, 2004, at B03.

144 Id.

145 Cholesterol Recommendations Questioned, CTR. FOR SCI. PUB. INT. (Sept. 23, 2004), http://www.cspinet.org/new/200409231.html.

146 Id.

147 Kassirer, supra note 143. In fact, the conflicts of interest in these guidelines ran deep. Scientists working for the NIH, the organization that funded the NCEP studies, had been granted exemptions from the NIH's normal rules against receiving funding from industry. Other NIH directors also had financial conflicts that could have potentially biased them. Id.

148 CTR. FOR SCI. PUB. INT., supra note 145.

149 Id.

150 Id.

151 Johnson & Stricker, supra note 68, at 283.

152 See Noah, supra note 49, at 420.

153 See id. at 420, 422.

154 Id. at 420.

155 Lohr, supra note 10, at 53.

156 Id. at 52; see Noah, supra note 49, at 423 (noting that antitrust issues are more likely to arise when guidelines are promulgated by insurance companies, who have a clear conflict of interest, versus when they are developed by respected medical organizations).

157 John Abramsom & Barbara Starfield, The Effect of Conflict of Interest on Biomedical Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?, 18 J. AM. BD. FAM. MED. 414, 414 (2005).

158 Jeanne Lenzer, Alteplase for Stroke: Money and Optimistic Claims Buttress the “Brain Attack” Campaign, 324 BRIT. MED. J. 723, 726 (2002).

159 Id.

160 Id.

161 Id.

162 Id. at 725; Kassirer, supra note 143.

163 Johnson & Stricker, supra note 68, at 284. One article in the Journal of the American Medical Association noted that “[a]ll guideline committees begin with implicit biases and values, which affects the recommendations they make.” Shaneyfelt & Centor, supra note 107, at 868.

164 See Timothy Stoltzfus Jost, Oversight of Marketing Relationships Between Physicians and the Drug and Device Industry: A Comparative Study, 36 AM. J.L. & MED. 326, 333 (2010).

165 Tricoci et al., supra note 105, at 837.

166 Shaneyfelt & Centor, supra note 107, at 868.

167 Lohr, supra note 10, at 52.

168 See Katy Butler, What Broke My Father's Heart, N.Y. TIMES SUNDAY MAG., June 20, 2010, at MM38.

169 Id.

170 Id.

171 Id.

172 Niteesh K. Choudhry et al., Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry, 287 JAMA 612, 614-15 (2002).

173 Id. at 614.

174 Id.

175 Id.

176 Id. at 615.

177 Id.

178 Id.

179 Id.

180 Johnson & Stricker, supra note 68, at 285.

181 Jost, supra note 164, at 327.

182 Id. at 332. Continuing medical education may be required for continued licensure. Id.

183 Id. at 331.

184 Id. at 333.

185 Id. at 332, 332 n.27.

186 Abramsom & Starfield, supra note 157, at 416.

187 Noah, supra note 49, at 397.

188 See id. at 408-09; Richard Smith, Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies, 2 PLOS. MED. 0364, 0365 (2005) (“[P]eer review [is] a process that research has anyway been shown to be an ineffective lottery prone to bias and abuse.”).

189 Noah, supra note 49, at 398.

190 Id. at 406.

191 Id. at 406-07.

192 Jost, supra note 164, at 332.

193 Id.

194 Noah, supra note 49, at 411.

195 Id.

196 See id.

197 See id. at 408. Even those researching the existence of conflicts of interest in the guideline process are not impervious to such conflicts. Authors of a 2002 study noted that they had attended events funded or sponsored by the pharmaceutical industry. Avraham, Clinical Practice Guidelines, supra note 58, at 29 n.137.

198 Noah, supra note 49, at 407.

199 See id. at 408.

200 See id. at 409.

201 Id.

202 Id. at 399-400.

203 Id. at 406; see also Johnson & Stricker, supra note 68, at 284 (noting that panelists for a particular study conducted on hypertension drugs had financial interests in the drug companies who produced the recommended medicine and therefore stood to gain from the guidelines).

204 Noah, supra note 49, at 407.

205 Abramsom & Starfield, supra note 157, at 414.

206 Smith, supra note 188, at 0365.

207 See id.

208 Id.

209 Id.

210 Id. at 0365-66

211 See Noah, supra note 49, at 412; Abramsom & Starfield, supra note 157.

212 See Noah, supra note 49, at 405.

213 See Johnson & Stricker, supra note 68.

214 See id. at 285.

215 Lisa Cosgrove et al., Developing Unbiased Diagnostic and Treatment Guidelines in Psychiatry, 360 NEW ENG. J. MED. 2035, 2035-36 (2009).

216 Id. at 2036.

217 See Robert Steinbrook, Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees, 353 NEW ENG. J. MED. 116, 116 (2005).

218 See id. Other guidelines issued by the American College of Rheumatology were based on the same studies used by the FDA and also endorsed use of the drugs until the drugs were withdrawn from the market. All four authors of the American College of Rheumatology's guidelines had financial ties to the drug manufacturers. See Abramsom & Starfield, supra note 157, at 416.

219 Kassirer, supra note 143.

220 Press Release, Conn. Att’y Gen.'s Office, supra note 6.

221 See id.

222 Id. Unsurprisingly, insurance companies support characterizations of Lyme disease that require only two to four weeks of antibiotic treatment. By diminishing treatment time, companies save large sums of money. See Unger, supra note 23.

223 See WEINTRAUB, supra note 8, at 213.

224 See id.

225 Press Release, Conn. Att’y Gen.'s Office, supra note 6.

226 Id.

227 Id.

228 See id.

229 Johnson & Stricker, supra note 68, at 283.

230 Id.

231 Press Release, Conn. Att’y Gen.'s Office, supra note 6. The 2000 IDSA panel likewise included conflicts of interest. Eleven out of the twelve panelists had economic interests in the Lyme vaccines that were in development at the time. The eleven panelists had additionally received funding from industry and stood to gain from potential patents and the development of particular diagnostic tests. WEINTRAUB, supra note 8, at 315.

232 Press Release, Conn. Att’y Gen.'s Office, supra note 6.

233 Id.

234 Id.

235 Id.

236 Id.

237 Id.

238 Id.

239 Id.

240 Special Review Panel Unanimously Upholds Lyme Disease Treatment Guidelines, INFECTIOUS DISEASES SOC’Y OF AM. (April 22, 2010), http://www.idsociety.org/Lyme_Review_Panel_News_Release/.

241 Id. The IDSA report stated that, “there has yet to be a single high quality clinical study that demonstrates comparable benefit to prolonging antibiotic therapy beyond one month.” INFECTIOUS DISEASES SOC’Y OF AM., FINAL REPORT OF THE LYME DISEASE REVIEW PANEL (2010), available at http://www.idsociety.org/uploadedFiles/IDSA/Topics_of_Interest/Lyme_Disease/IDSALymeDiseaseFinalReport.pdf. The panel stated that its conclusion was “medically/scientifically justified in light of all the evidence and information provided.” Id.

242 Johnson & Stricker, supra note 68, at 286.

243 Simpson, supra note 22, at 159-60.

244 See, e.g., Joshua A. Boyce et al., Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NAID-Sponsored Expert Panel, 126 J. ALLERGY CLINICAL IMMUNOLOGY S1 (2010), available at http://download.journals.elsevierhealth.com/pdfs/journals/0091-6749/PIIS0091674910015666.pdf; NAT’L HEART LUNG & BLOOD INST., EXECUTIVE SUMMARY: DETECTION, EVALUATION, AND TREATMENT OF HIGH BLOOD CHOLESTEROL IN ADULTS (ADULT TREATMENT PANEL III) (2001), available at http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3xsum.pdf; NAT’L HEART LUNG & BLOOD INST., EVIDENCE REPORT: CLINICAL GUIDELINES ON THE IDENTIFICATION, EVALUATION, AND TREATMENT OF OVERWEIGHT AND OBESITY IN ADULTS (1998), available at http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf; PANEL ON ANTIRETROVIRAL THERAPY & MED. MGMT. OF HIV-INFECTED CHILDREN, GUIDELINES FOR THE USE OF ANTIRETROVIRAL AGENTS IN PEDIATRIC HIV INFECTION (2011), available at http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf.

245 See, e.g., NAT’L CANCER INST., Mission, NAT’L INSTS. OF HEALTH, http://www.nih.gov/about/almanac/organization/NCI.htm (last reviewed Dec. 31, 2011) (“As the leader of the National Cancer Program, NCI provides vision and leadership to the global cancer community.”); NAT’L INST. OF NEUROLOGICAL DISORDERS & STROKE, Mission, NAT’L INSTS. OF HEALTH, http://www.nih.gov/about/almanac/organization/NINDS.htm (last reviewed Dec. 31, 2011) (“[T]he National Institute of Neurological Disorders and Stroke … has occupied a central position in the world of neuroscience for nearly 60 years.”).

246 Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Services Funding is Sought and Responsible Prospective Contractors, 76 Fed. Reg. 53,256 (Aug. 25, 2011) (to be codified at 540 C.F.R. pt. 50).

247 Id.

248 Id.

249 The regulation excludes Phase I Small Business Innovation Research and Small Business Technology Transfer applicants or awards. Id.

250 Id. at 53,259.

251 In the event that the institution does not have an Internet presence, the regulation dictates that institutions must make their policies available upon request. Id. at 53,285.

252 Investigators are defined as “the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.” Id. at 53,284.

253 Significant financial interests are defined to include generally any interest in excess of $5000 in either a publicly traded or non-publicly traded entity or intellectual property rights. The definition also includes the occurrence of reimbursed travel expenses related to an investigator's institutional responsibilities. Id. at 53,284, 53,289.

254 The regulation also mandates the filing of updated disclosure forms at least annually as well as upon the incident of acquisition of new significant financial interests. Id. at 53,285.

255 Id. at 53,285-86, 53,290-91.

256 Id. at 53,286, 53,291.

257 HHS: What We Do, DEP't HEALTH & HUMAN SERVS., http://www.hhs.gov/about/whatwedo.html (last visited Dec. 31, 2011).

258 Institutes, Centers & Offices, NAT’L INSTS. OF HEALTH, http://www.nih.gov/icd/ (last reviewed on Dec. 31, 2011). For a complete listing of all NIH Institutes, see id.

259 See supra text accompanying note 244.

260 NIH Budget, NAT’L INSTS. OF HEALTH, http://www.nih.gov/about/budget.htm (last reviewed on Dec. 31, 2011).

261 See Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Services Funding is Sought and Responsible Prospective Contractors, 76 Fed. Reg. at 53,256.

262 See Jennifer A. Henderson & John J. Smith, Financial Conflicts of Interest in Medical Research: Overview and Analysis of Federal and State Controls, 57 FOOD & DRUG L.J. 445, 450 (2002).

263 See Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Services Funding is Sought and Responsible Prospective Contractors, 76 Fed. Reg. at 53,278.

264 Id.

265 U.S. DEP't HEALTH & HUMAN SERVS., GUIDANCE FOR CLINICAL INVESTIGATORS, INDUSTRY AND FDA STAFF FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS, 1-2 (2011), available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf.

266 21 C.F.R. § 54 (2011).

267 Id. § 54.1.

268 Id. § 54.2.

269 Id. § 54.1.

270 See GUIDANCE FOR CLINICAL INVESTIGATORS, supra note 265, at 2.

271 Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Services Funding is Sought and Responsible Prospective Contractors, 76 Fed. Reg. at 53,278.

272 42 U.S.C. § 1395nn (2006).

273 Stark Law FAQs, STARKLAW.ORG, http://starklaw.org/stark-law-faq.htm (last visited Dec. 31, 2011).

274 Compare About Stark Law, STARKLAW.ORG, http://starklaw.org/stark_law.htm (last visited Dec. 31, 2011) (discussing the arguments of critics of physician self-referrals, the practice prohibited by Stark), with Steven D. Wales, The Stark Law: Boon or Boondoggle? An Analysis of the Prohibition on Physician Self-Referrals, 27 L. PSYCHOL. REV. 1, 10-11, 22 (2003) (internal quotation marks omitted) (“It may not be easy to determine if a physician's practice conforms to these requirements. It is certainly not intuitive … . [I]t is the many exceptions to Stark that make it a law of truly awesome complexity … . What cannot be done is explained in one sentence. Definitions, separated into two sections, require little over two pages. Exceptions, however, fill nearly nine pages of the statute. One guidebook for doctors and lawyers uses eighteen pages and over seventy footnotes in its effort to make these exceptions clear … . Stark Law has been described in the following ways: confusing, complicated, over-reaching, too complex and intrusive … . The only thing that's clear is just how unclear the Stark laws are because of their enormous ambiguity … .”).

275 See Stark Law FAQs, supra note 273.

276 Tammy Asher, Unprecedented Antitrust Investigation into the Lyme Disease Treatment Guidelines Development Process, 46 GONZ. L. REV. 117, 124 (2011). See also Richard Wolfram, Connecticut Attorney General Investigation and Settlement Highlights Possible Applicability of Antitrust Standard Setting Law to the Development of Clinical Practice Guidelines, ANTITRUST HEALTH CARE CHRON. (Am. Bar Assoc. Antitrust Section), Nov. 2008, at 8, available at http://lyme.kaiserpapers.org/pdfs/lymeantitrust.pdf, for a similar analysis.

277 FROM THE PRESIDENT, INFECTIOUS DISEASES SOC’Y OF AM. (July 1, 2007) http://newsmanager.commpartners.com/idsa/issues/2007-07-01/16.html.

278 Id.

279 John D. Kraemer & Lawrence O. Gostin, Science, Politics and Values: The Politicization of Professional Practice Guidelines, 301 JAMA 665 (2009).

280 See generally Asher, supra note 276.

281 FTC Guide to the Antitrust Laws, FED. TRADE COMM’N, http://www.ftc.gov/bc/antitrust/index.shtm (last modified Jan. 6, 2010).

282 15 U.S.C. § 1 (2006).

283 Asher, supra note 276, at 133.

284 See id. (discussing Jung. v. Ass’n of Am. Med. Colls., 300 F. Supp. 2d 119 (D.C. Cir. 2004)). See also id. at 135 (citation omitted) (noting that “‘the development of treatment guidelines is analogous to standard-setting.’ Consequently the IDSA's Lyme treatment guidelines are similar to the ACGME's accreditation standards in Jung … .”).

285 Thomas A. Piraino, Making Sense of the Rule of Reason: A New Standard for Section 1 of the Sherman Act, 47 VAND. L. REV. 1753, 1753, 1771-72; see also Asher, supra note 276, at 132.

286 Kraemer & Gostin, supra note 279, at 666.

287 Asher, supra note 276, at 137.

288 Id. (quoting GTE New Media Servs. Inc. v. Ameritech Corp., 21 F. Supp. 2d 27, 42 (D.C. Cir. 1998)) (internal quotation marks omitted).

289 Id. at 138 (quoting ABA SECTION OF ANTITRUST LAW, ANTITRUST AND ASSOCIATIONS HANDBOOK 1 (2009)) (internal quotation marks omitted).

290 Id. at 141.

291 Id. at 131-45. See also Richard Wolfram, Clinical Practice Guideline Development and Antitrust Law, 301 JAMA 2548, 2548-49 (2009), for additional support of this theory.

292 ANTITRUST DIV., Price Fixing, Bid Rigging, and Market Allocation Schemes: What They Are and What to Look For, DEP't OF JUSTICE 1, http://www.justice.gov/atr/public/guidelines/211578.pdf (last visited Dec. 31, 2011). Corporations who violate antitrust law may be subject to fines of up to $100 million. Individuals may be fined up to $1 million and may receive a prison sentence of up to ten years. Id.

293 Steven L. Schwarcz, Private Ordering, 97 NW. U. L. REV. 319, 319 (2002).

294 Participating journals include the Annals of Internal Medicine, British Medical Journal, Canadian Medical Association Journal, Chinese Medical Journal, Croatian Medical Journal, Journal of the American Medical Association, Nederlands Tijdschrift voor Geneeskunde (The Dutch Medical Journal), New England Journal of Medicine, New Zealand Medical Journal, The Lancet, The Medical Journal of Australia, Revista Médica de Chile, Tidsskrift for Den Norske Lægeforening (The Journal of the Norwegian Medical Association), and Ugeskrift for Laeger (Journal of the Danish Medical Association). About the International Committee of Medical Journals Editors, INT’L COMM. OF MED. JOURNAL EDITORS, http://www.icmje.org/about.html (last visited Dec. 31, 2011).

295 Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Conflicts of Interest, INT’L COMM. OF MED. J. EDITORS, http://www.icmje.org/ethical_4conflicts.html (last visited Dec. 31, 2011).

296 Id.

297 Id.

298 Id. The ICMJE has developed a standardized form used for reporting conflicts of interest. ICMJE Form for Disclosure of Potential Conflicts of Interest, INT’L COMM. OF MED. J. EDITORS, http://www.icmje.org/coi_disclosure.pdf (last visited Dec. 31, 2011).

299 See Uniform Requirements for Manuscripts, supra note 295.

300 ICMJE Form for Disclosure, supra note 298.

301 David Armstrong, New Conflict Rules at Medical Journals, WALL ST. J., Oct. 14, 2009, at A3.

302 See Uniform Requirements for Manuscripts, supra note 295.

303 Id.

304 Id.

305 Armstrong, supra note 301.

306 See, e.g., Michael H. Buamann et al., ACCP Evidence-Based Guideline Development: A Successful and Transparent Approach Addressing Conflict of Interest, Funding and Patient-Centered Recommendations, 132 CHEST 1015 (2007).

307 PhRMA Code on Interactions with Healthcare Professionals Reaches New Milestone with 54th Signatory Company, PHARMACEUTICAL RES. & MFRS. OF AM., (Oct. 28, 2010), http://www.phrma.org/media/releases/phrma-code-interactions-healthcare-professionals-reaches-newmilestone-54th-signatory.

308 Id.

309 Code on Interactions with Healthcare Professionals, PHARMACEUTICALS RES. & MFRS. OF AM., http://www.phrma.org/sites/default/files/369/phrma_marketing_code_2008-1.pdf (last updated Jan. 2009).

310 David M. Studdert et al., Financial Conflicts of Interest in Physicians’ Relationships with the Pharmaceutical Industry—Self Regulation in the Shadow of Federal Prosecution, 351 NEW ENG. J. MED. 1891, 1898 (2004).

311 Lohr, supra note 10, at 54.

312 Editorial, Clinical Practice Guidelines and Conflict of Interest, 173 CANADIAN MED. ASS’N J. 1297, 1297 (2005).

313 See Johnson & Stricker, supra note 68.

314 Choudhry et al., supra note 172, at 616.

315 Id.

316 Id.

317 Id.

318 Kassirer, supra note 143.