Judging the scientific and medical literature: Some legal implications of changes to biomedical research and publication

Oxford Journal of Legal Studies

Volumn 28, Issue 3, 2008, Pages 523-561

  Edmond, Gary ^a,b,c  

^a UNIVERSITY OF WOLLONGONG   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c UNIVERSITY OF NEW SOUTH WALES   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 51049124508     PISSN: 01436503     EISSN: 14643820     Source Type: Journal    
DOI: 10.1093/ojls/gqn021     Document Type: Article

References (252)

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6. Ibid 2
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8. Chubin and Hackett (n 3) 8.
9. Daubert v Merrell Dow Pharmaceuticals, Inc. 509 US 579, 593 (1993) (italics added).
10. Other influential cases include McTear & Imperial Tobacco Ltd [2005] CSOH 69;
11. Seltsam Pty Ltd v McGuiness (2000) 49 NSWLR 262.
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14. A prominent example is Kozinski J in Daubert on remand: Daubert v Merrell Dow Pharmaceuticals, Inc. 43 F.3d 1311, 1318 (9th Cir. 1995).
15. See generally, G Edmond and D Mercer, 'The Invisible Branch: The Authority of Science Studies in Expert Evidence Jurisprudence' in G Edmond (ed), Expertise in Regulation and Law (Ashgate, Aldershot 2004) 197.
16. LaFollette (n 5) 2.
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28. LaFollette (n 8) 92.
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35. There are literally tens of thousands of specialized science and medical journals.
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44. C Medawar and C Hardon, Medicines Out of Control (Aksant Academic Press, Amsterdam 2004);
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49. AMA Council of Scientific Affairs, Influence of Funding Source on Outcome, Validity, and Reliability of Pharmaceutical Research (2004) 4. According to AMA research, at least 25 per cent of academic investigators receive industry funding for their biomedical research, and at least one-third have personal financial ties with industry sponsors.
50. S Krimsky, Science in the Private Interest (Rowman and Littlefield, Lanham 2003) 75-9.
51. P Mirowski and R Van Horn, 'The Contract Research Organization and Commercialization of Scientific Research' (2005) 25 Social Studies of Science 503-48, 506 (italics added);
52. M Jacobson, 'Lifting the Veil of Secrecy from Industry Funding of Nonprofit Health Organizations' (2005) 11 Int J Occup Environ Health 349-55.
53. W Wagner and D Michaels, 'Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research' (2004) 30 Am J Law Med 119-54.
54. M Angell and others, 'Is Academic Medicine for Sale?' (2000) 343 NEJM 508-10;
55. T Brennan and others, 'Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers' (2006) 295 JAMA 429-33.
56. Angell (n 29) 11 recounts startling figures about the profitability of the pharmaceutical industry. In 2002, 'The Combined Profits for the Ten Drug Companies in the Fortune 500 ($35.9 billion) were more than the Profits for all the Other 490 Businesses Put Together ($33.7 billion)'.
57. An illuminating example is provided by P Rabinow, Making PCR: A Story of Biotechnology (University of Chicago Press, Chicago 1996).
58. Angell (n 29) 263.
59. A Relman, 'Dealing with Conflicts of Interest' (1984) 310 NEJM 1182-3;
60. D Rennie, A Flanagin and R Glass, 'Conflicts of Interest in the Publication of Science' (1991) 266 JAMA 266-7;
61. D Koshland, 'Conflict of Interest Policy' (1992) 257 Science 595;
62. J Kassirer and M Angell, 'Financial Conflicts of Interest in Biomedical Research' (1993) 329 NEJM 570-1;
63. D Thompson, 'Understanding Financial Conflicts of Interest' (1993) 329 NEJM 573-6;
64. R Smith, 'Conflict of Interest and the BMJ' (1994) 308 BMJ 4-5;
65. D Korn, 'Conflicts of Interest in Biomedical Research' (2000) 282 JAMA 2234-7;
66. P Campbell, 'Declaration of Financial Interests' (2001) 412 Nature 751;
67. F Davidoff and others, 'Sponsorship, Authorship and Accountability' (2001) 345 NEJM 825-7;
68. C DeAngelis and others, 'Reporting Financial Conflicts of Interest and Relationships between Investigators and Research Sponsors' (2001) 286 JAMA 89-91;
69. J Drazen and G Curfman, 'Financial Associations of Authors' (2002) 346 NEJM 1901-2.
70. S Hilgartner, 'The Dominant View of Popularization: Conceptual Problems, Political Uses' (1990) 20 Soc Stud Sci 519-39.
71. K Rothman, 'Conflict of Interest: The New McCarthyism in Science' (1993) 269 JAMA 2782-4.
72. International Committee of Medical Journal Editors, 'Statement: Conflict of interest' (1993) 118 Ann Intern Med 646-7.
73. Mirowski and Van Horn (n 33) 518 (italics added).
74. 'Meta-analyses' are studies that combine the results of a number of studies in order to increase the statistical power.
75. J Bekelman, Y Li and C Gross, 'Scope and Impact of Financial Conflict of Interest in Biomedical Research (2003) 289 JAMA 454-65, 463 (italics added).
76. Ibid 456, 459: 'The Summary OR for All 8 Articles, which Together Evaluated 1140 Original Articles, was 3.60 (95% CI, 2.63-4.91).' RCT stands for randomized controlled trials. Reproduced with the permission of the JAMA.
77. J Lexchin and others, 'Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review' (2003) 326 BMJ 1167-76, 1169.
78. N Azimi and G Welch, 'The Effectiveness of Cost-Effectiveness Analysis in Containing Costs' (1998) 13 J Gen Intern Med 664-9;
79. C Bell and others, 'Bias in Published Cost Effectiveness Studies: Systematic Review' (2006) 332 BMJ 699-703.
80. L Kjaergard and B Als-Nielsen, 'Association Between Competing Interests and Authors' Conclusions: Epidemiological Study of Randomized Clinical Trials Published in the BMJ' (2002) 325 BMJ 249-53.
81. R Davidson, 'Source of Funding and Outcome of Clinical Trials' (1986) 1 J Gen Intern Med 155-8.
82. G Browman, 'Standards of Proof, Standards of Practice, and Proof of Standards: A Tale of Two Trials' (2005) 23 J Clin Oncol 2583-5, 2585;
83. Kassirer (n 29). Pharmaceutical companies tend to promote new drugs - often minor variations on existing products, or new applications - as older patent protections expire.
84. F vom Saal and C Hughes, 'An Extensive New Literature Concerning Low-Level Dose Effects of Bisphenol A Shows the Need for a New Risk Assessment' (2005) 113 Environ Health Perspect 926-33.
85. L Friedman and E Richter, 'Relationship Between Conflicts of Interest and Research Results' (2004) 19 J Gen Intern Med 51-6, 54.
86. M Friedberg and others, 'Evaluation of Conflict of Interest in Economic Analyses of New Drugs used in Oncology' (1999) 282 JAMA 1453-7.
87. H Stelfox and others, 'Conflict of Interest in the Debate Over Calcium-Channel Antagonists' (1998) 338 NEJM 101-6;
88. P Rochon and others, 'A Study of Manufacturer-supported Trials of Nonsteroidal Anti-inflammatory Drugs in the Treatment of Arthritis' (1994) 154 Archives Intern Med 157-63;
89. A Chan and D Altman, 'Identifying Outcome Reporting Bias in Randomized Trials on PubMed: Review of Publications and Survey of Authors' (2005) 330 BMJ 753-6;
90. D Rennie, 'Thyroid Storm' (1997) 277 JAMA 1238-43.
91. M Bhanari and others, 'Association Between Industry Funding and Statistically Significant Pro-industry Findings in Medical and Surgical Randomized Trials' (2004) 170 Canadian Med Assoc J 477-80;
92. B Als-Nielsen and others, 'Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Event?' (2003) 290 JAMA 921-8;
93. C Baker and others, 'Quantitative Analysis of Sponsorship Bias in Economic Studies of Anti-depressants' (2003) 183 Brit J Psych 498-506;
94. J Lexchin, 'Implications of Pharmaceutical Industry Funding on Clinical Research' (2005) 39 Ann Pharmacother 194-7.
95. S Krimsky and others, 'Financial Interest of Authors in Scientific Journals: A Pilot Study of 14 Publications' (1996) 2 Sci Eng Ethic 395-410;
96. S Krimsky and L Rothenberg, 'Financial Interest and its Disclosure in Scientific Publications' (1998) 280 JAMA 225-6.
97. S Krimsky and L Rothenberg, 'Conflict of Interest in Science and Medical Journals: Editorial Practices and Author Disclosures' (2001) 7 Sci Eng Ethics 205-18.
98. Krimsky (n 32) 7, 75-9;
99. P Lurie and others, 'Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings' (2006) 295 JAMA 1921-8;
100. B Shamsaunder and L Bero, 'Financial Ties and Conflicts of Interest between Pharmaceutical and Tobacco Companies' (2002) 288 JAMA 738-44.
101. R Steinbrook, 'Gag Clauses in Clinical-trial Agreements' (2005) 352 NEJM 2160-2;
102. S Rosenberg, 'Secrecy in Medical Research' (1996) 334 NEJM 392-4;
103. K Dickersin and others, 'Factors Influencing Publication of Research Results' (1992) 267 JAMA 374-8;
104. A Chan and others, 'Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles' (2004) 291 JAMA 2457-65;
105. G Antes and I Chalmers, 'Under-reporting of Clinical Trials is Unethical' (2003) 361 Lancet 978-9;
106. R Horton, 'The Less Acceptable Face of Bias' (2000) 356 Lancet 959-60.
107. P Gøtzsche and others, 'Constraints on Publication Rights in Industry-initiated Clinical Trials' (2006) 295 JAMA 1645-6, 1646.
108. S Krimsky, 'Publication Bias, Data Ownership, and the Funding Effect in Science: Threats to the Integrity of Biomedical Research' in W Wagner and R Steinzor (eds) Rescuing Science from Politics: Regulation and the Distortion of Scientific Research (CUP, Cambridge 2006) 60, 69.
109. Dong's contract with Flint Laboratories (subsequently acquired by Knoll) for research on Synthroid specified details of experimental design and data analysis and contained the following clause: 'All Information contained in this Protocol is Confidential and is to be used by the Investigator only for the Conduct of this Study. Data Obtained by the Investigator while Carrying out this Study is also Considered Confidential and is not to be Published or Otherwise Released Without Written Consent from Flint Laboratories.' See also, D Nathan and D Weatherall, 'Academic Freedom in Clinical Research' (2002) 347 NEJM 1368-71.
110. H Melander and others, 'Evidence B(i)ased Medicine - Selective Reporting from Studies Sponsored by Pharmaceutical Industry: Review of Studies in New Drug Applications' (2003) 326 BMJ 1171-3.
111. J Hetherington and others, 'Retrospective and Prospective Identification of Unpublished Controlled Trials: Lessons from a Survey of Obstetricians and Pediatricians' (1989) 84 Pediatrics 374-80.
112. A Chan and others, 'Outcome Reporting Bias in Randomized Trials Funded by the Canadian Institutes of Health Research' (2004) 171 Canadian Med Assoc J 735-40.
113. D Rennie, 'Trial Registration: A Great Idea Switches from Ignored to Irresistible' (2004) 292 JAMA 1359-62;
114. J Stern and J Simes, 'Publication Bias: Evidence of Delayed Publication in a Cohort Study of Clinical Research Projects' (1997) 315 BMJ 640-5.
115. AMA Council of Scientific Affairs (n 31).
116. Hetherington and others, Retrospective and Prospective (n 68) 378.
117. Wagner and Michaels (n 34) 129.
118. E Huth, 'Guidelines on Authorship of Medical Papers' (1986) 104 Ann Intern Med 269-74;
119. R Epstein, 'Six Authors in Search of a Citation: Villains or Victims of the Vancouver Convention?' (1993) 306 BMJ 765-7;
120. D Rennie and A Flanagin, 'Authorship! Authorship! Guests, Ghosts, Grafters, and the Two-Sided Coin' (1994) 271 JAMA 469-71;
121. M Biagioli and P Galison (eds), Scientific Authorship: Credit and Intellectual Property in Science (Routledge, New York 2002).
122. S Rampton and J Stauber, Trust Us, We're Experts (J P Tarcher, New York 2001);
123. S Rankin Bohme, J Zorabedian and D Egilman, 'Maximizing Profit and Endangering health: Corporate Strategies to Avoid Litigation and Regulation' (2005) 11 Int J Occup Environ Health 338-48, 346;
124. D Healy and D Cattell, 'Interface Between Authorship, Industry and Science in the Domain of Therapeutics' (2005) 183 Brit J Psych 2813-4.
125. A Flanagin and others, 'Prevalence of Articles with Honorary Authors and Ghost Authors in Peer-reviewed Medical Journals' (1998) 280 JAMA 222-4;
126. G Mowatt and others, 'Prevalence of Honorary and Ghost Authorship in Cochrane Review' (2002) 287 JAMA 2769-71;
127. D Rennie, V Yank and L Emanuel, 'When Authorship Fails: A Proposal to make Contributors Accountable' (1997) 278 JAMA 579-85;
128. R Bhopal and others, 'The Vexed Question of Authorship: Views of Researchers in a British Medical Faculty' (1997) 314 BMJ 1009-12;
129. D Shapiro, N Wenger and M Shapiro, 'The Contributions of Authors of Multiauthored Biomedical Research Papers' (1994) 271 JAMA 438-42.
130. D Healy, 'Shaping the Intimate: Influences on the Experience of Everyday Nerves' (2004) 34 Soc Stud Sci 219-45, 231-2.
131. Wagner and Michaels (n 34) 120-2;
132. D Michaels and C Monforton, 'Scientific Evidence in the Regulatory System: Manufacturing Uncertainty and the Demise of the Formal Regulatory System' (2005) 13 J Law Pol 17-41.
133. L Bero and others, 'Lawyer Control of the Tobacco Industry's External Research Program' (1995) 274 JAMA 241-7.
134. T Bodenheimer, 'Uneasy Alliance - Clinical Investigators and the Pharmaceutical Industry' (2000) 342 NEJM 1539-44;
135. L Bero and D Rennie, 'Influences on the Quality of Published Drug Studies' (1996) 12 Int J Technol Assess Healthcare 209-37;
136. B Djulbegovic and others, 'The Uncertainty Principle and Industry Sponsored Research' (2000) 356 Lancet 635-8.
137. H Johanesen and P Gotzsche, 'Problems in the Design and Reporting of Trials of Antifungal Agents Encountered during Meta-analysis' (1999) 282 JAMA 1752-9;
138. G Swaen and J Meijers, 'Influence of Design Characteristics on the Outcome of Retrospective Cohort Studies' (1988) 45 Brit J Indus Med 624-9.
139. Bekelman, Li and Gross (n 45) 458;
140. K Huwiler-Müntener and others, 'Quality of Reporting of Randomized Trials as a Measure of Methodologic Quality' (2002) 287 JAMA 2801-4.
141. AMA Council of Scientific Affairs (n 31) 3 (italics added).
142. Angell (n 29).
143. D Safer, 'Design and Reporting Modifications in Industry-sponsored Comparative Psychopharmacology Trials' (2002) 190 J Ment Disord 583-92;
144. S Epstein, Impure Science (University of California Press, Berkeley 1996).
145. Krimsky provides an example of the journal Transplantation and Dialysis rejecting a favourably reviewed submission - which questioned the benefits of a pharmaceutical - because of concerns expressed by the journal's marketing department. S Krimsky, 'Publication Bias, Data Ownership, and the Funding Effect in Science: Threats to the Integrity of Biomedical Research' in W Wagner and R Steinzor (eds) Rescuing Science from Politics: Regulation and the Distortion of Scientific Research (CUP, Cambridge 2006) 72.
146. D Rier, 'The Versatile "Caveat" Section of an Epidemiological Paper' (1999) 21 Sci Commun 3-37.
147. Ibid 17.
148. G Myers, 'Texts as Knowledge Claims: The Social Construction of Two Biological Articles' (1985) 15 Soc Stud Sci 593-630;
149. K Hyland, 'Talking to the Academy: Forms of Hedging in Science Research Articles' (1996) 13 Written Commun 251-81, 275;
150. K Knorr-Cetina, The Manufacture of Knowledge (Pergamon, Oxford 1981) 102;
151. B Latour and S Woolgar, Laboratory Life (Sage, Beverley Hills 1979).
152. N Ashford, 'Disclosure of Interests: A time for clarity' (1995) 28 Am J Indus Med 611-2.
153. G Edmond, 'The Law-Set: The legal-scientific Production of Medical Propriety' (2001) 26 Sci, Tech Human Val 191-226.
154. P Huston and D Moher, 'Redundancy, Disaggregation, and the Integrity of Medical Research' (1996) 347 Lancet 1024-6;
155. P Gotzsche, 'Multiple Publication of Reports of Drug Trials' (1989) 36 Euro J Clin Pharmacol 429-32;
156. E von Elm and others, 'Different Patterns of Duplicate Publication: An Analysis of Articles used in Systematic Reviews' (2004) 291 JAMA 974-80.
157. D Rennie, 'Fair Conduct and Fair Reporting of Clinical Trials' (1999) 282 JAMA 1766-8;
158. M Tramér and others, 'Impact of Covert Duplicate Publication on Meta-Analysis: A Case Study' (1997) 315 BMJ 635-40;
159. J Kassirer and M Angell, 'Redundant Publication: A Reminder' (1995) 333 NEJM 449-431.
160. Gøtzsche (n 88).
161. R Simes, 'Publication Bias: The Case for an International Registry of Clinical Trials' (1986) 4 J Clin Oncol 1529-41;
162. Johanesen and Gøtzsche (n 77) 1756, 1758;
163. C Olson and others, 'Publication Bias in Editorial Decision Making' (2002) 287 JAMA 2825-8;
164. A Herxheimer, 'Open Access to Industry's Clinically Relevant Data' (2004) 329 BMJ 64-5.
165. M Pfeiffer and G Snodgrass, 'The Continued Use of Retracted, Invalid Scientific Literature' (1990) 263 JAMA 1420-3;
166. P Friedman, 'Correcting the Literature following Fraudulent Publication' (1990) 263 JAMA 1416-9;
167. H Sox and D Rennie, 'Research Misconduct, Retraction and Cleansing the Medical Literature: Lessons from the Poehlman Case' (2006) 144 Ann Int Med 609-13.
168. R Smith, 'Maintaining the Integrity of the Scientific Record: Editors make a Move' (2001) 323 BMJ 588.
169. The Uniform Requirements also detail policies on 'Corrections, Retractions and "Expressions of Concern"', 'Redundant Publication', 'Advertising', 'Supplements, Theme Issues and Special Series'.
170. International Committee of Medical Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication I§I.D (2005) (italics added) (www.ICMJE.org visited 19 December 2006).
171. S Krimsky, 'Small Gifts, Conflicts of Interest, and the zero-Tolerance Threshold in Medicine' (2003) 3 Am J Bioethics 50-2.
172. C DeAngelis, 'The Influence of Money on Medical Science' (2006) 296 JAMA 996-8, 997.
173. A Flanagin, P Fontanarosa and C DeAngelis, 'Update on JAMA's Conflict of Interest Policy' (2006) 296 JAMA 220-1.
174. R Horton and R Smith, 'Time to Register Randomized Trials' (1999) 354 Lancet 1138-9;
175. K Dickersin, 'Why Register Clinical Trials: Revisited' (1992) 13 Cont Clin Trials 170-7;
176. A Maynard and K Bloor, 'Regulating the Pharmaceutical Industry' (1997) 315 BMJ 200-1, 201.
177. ICMJE, Uniform Requirements, III.J.
178. Ibid;
179. C DeAngelis and others, 'Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors' (2004) 351 NEJM 1250-1.
180. See also, C DeAngelis and others, 'Is this Clinical Trial Fully Registered? A Statement from the International Committee of Medical Journal Editors' (2005) 293 JAMA 2927-9, 2928;
181. Rennie (n 66) 1361. See also, the Consolidated Standards for Reporting of Trial Group (Consort) and the Cochrane Collaboration.
182. R Kelch, 'Maintaining the Public Trust in Clinical Research' (2002) 346 NEJM 285-7.
183. D Egilman and S Rankin Bohme, 'Over a Barrel: Corporate Corruption of Science and its Effects on Workers and the Environment' (2005) 11 Int J Occup Environ Health 331-7.
184. J Abraham, 'Making Regulation Responsive to Commercial Interests: Streamlining Drug Industry Watchdogs' (2002) 325 BMJ 1164-9.
185. Healy (n 73) 238;
186. C Whittington and others, 'Selective Serotonin Reuptake Inhibitors in Childhood Depression: Systematic Review of Published versus Unpublished Data' (2004) 363 Lancet 1341-5;
187. D Roth and others, 'Depressing Research' (2004) 363 Lancet 2087;
188. C Medawar, A Hardon and A Herxheimer, 'Depressing Research' (2004) 363 Lancet 2087.
189. Psaty, Weiss and Furberg (n 2) 2624;
190. P Fontanorosa and others, 'Postmarketing Surveillance - Lack of Vigilance, Lack of Trust' (2004) 292 JAMA 2647-50;
191. E Gale, 'Lessons from the Glitazones: A Story of Drug Development' (2001) 357 Lancet 1870-5.
192. J Braithwaite and P Drahos, Global Business Regulation (CUP, Cambridge 2000) 360-98;
193. J Abraham and H LawtonSmith (eds), Regulation of the Pharmaceutical Industry (Palgrave, London 2003).
194. C Cranor, Toxic Torts: Science, Law and the Possibility of Justice (CUP, Cambridge 2006) 348.
195. W Wagner, 'Importing Daubert to Administrative Agencies through the Information Quality Act' 12 J Law Pol 589-17, 602 (2001);
196. W Wagner, 'The "Bad Science" Fiction: Reclaiming the Debate Over the Role of Science in Public Health and Environmental Regulation' (2003) 66 Law Contemp Prob 63-134.
197. C DeAngelis, 'Conflict of Interest and the Public Trust' (2000) 284 JAMA 2237-8.
198. G Edmond, 'Judicial Representations of Scientific Evidence' (2000) 63 MLR 216-51.
199. E Wagner, E Field and L Grossman, 'Good Publication Practice for Pharmaceutical Companies' (2003) 19 Cur Med Res Opin 149-54.
200. H Collins, Changing Order (University of Chicago Press, Chicago 1992).
201. I Mitroff, The Subjective Side of Science (Elsevier, Amsterdam 1974);
202. M Mulkay, 'Norms and Ideology in Science' (1979) 4 Soc Sci Inform 637-56;
203. T Ward, 'English Law's Epistemology of Expert Testimony' (2006) 33 J Law Soc 572-95, 593-4.
204. S Jasanoff, Science at the Bar (Harvard University Press, Cambridge, MA 1995);
205. D Caudill and L LaRue, No Magic Wand: The Idealization of Science in the Law (Rowman and Littlefield, Lantham 2006).
206. B Latour, Science in Action (OUP, Milton Keynes 1987);
207. S Yearley, Making Sense of Science (Sage, London 2005);
208. D Hess, Science Studies: An Advanced Introduction (NYU Press, New York 1997).
209. J Potter, Representing Reality: Discourse, Rhetoric and Social Construction (Sage, London 1996)
210. S Yearley, 'The relationship between Epistemological and Sociological Cognitive Interests: Some Ambiguities Underlying the Use of Interest Theory in the Study of Scientific Knowledge' (1982) 13 Stud Hist Phil Sci 353-88, 375;
211. S Woolgar, 'Interests and Explanation in the Social Study of Science' (1981) 11 Soc Stud Sci 365-94.
212. Krimsky (n 32) 127, 131 (2003);
213. M Angell and J Kassirer, 'Editorials and Conflicts of Interest' (1996) 335 NEJM 1055-6, 1056.
214. Rothman (n 41) 2783-4 (italics added).
215. M Biagioli, 'Aporias of Scientific Authorship: Credit and Responsibility in Contemporary Biomedicine' in M Biagioli (ed), The Science Studies Reader (Routledge, New York 1999) 12, 26
216. Mirowski and Van Horn (n 33) 520.
217. P Fontanarosa and others, 'Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies' (2005) 294 JAMA 110-1.
218. The difficulty of assessing methodological quality has led collectives, like the Cochrane Collaboration, to adopt a methodological threshold rather than attempting to rank or assess quality.
219. T Koenig and M Rustad, In Defence of Tort Law (NYU Press, New York 2001);
220. W Haltom and M McCann, Distorting the Law: Politics, Media, and the Litigation Crisis (University of Chicago Press, Chicago 2004).
221. Shovlin v University of Medicine and Dentistry 50 F.Supp.2d 297 (D.N.J. 1998);
222. Cukier v American Medical Association 259 Ill.App.3d 159, 630 NERep.2d 1198 (1994).
223. D Michaels, 'Waiting for the Body Count: Corporate Decision Making and Bladder Cancer in the U.S. Dye industry (1988) 2 Med Anthropol Quart 215-32;
224. E Rosenthal, 'Who's Afraid of National Laws? Pesticide Corporations use Trade Negotiations to avoid Bans and Undercut Public Health Protections in Central America' (2005) 11 Int J Occup Environ Health 437-43.
225. M Galanter, 'Why the "Haves" come out Ahead: Speculations on the Limits of Legal Change' (1974) 9 Law Soc Rev 95-160;
226. Bohme, Zorabedian and Egilman (n 71).
227. For example, S Jasanoff, 'Law's Knowledge: Science for Justice in Legal Settings' (2005) 95 Am J Pub Health S49-58.
228. G Edmond, 'Judging Facts: Managing Expert Knowledges in Legal Decision-making' in G Edmond (ed), Expertise in Regulation and Law (Ashgate, Aldershot 2004) 136.
229. J Braithwaite, 'Rules and Principles: A Theory of Legal Certainty' (2002) 27 Aus J Legal Phil 47-82.
230. This can be controversial, as in Rogers v Whitaker (1992) 175 CLR 479, 487.
231. S Timmermans and M Berg, The Gold Standard: The Challenge of Evidence-based Medicine and Standardisation in Health Care (Temple University Press, Philadelphia 2003).
232. Healy (n 73) 236.
233. See also, T Pieters, 'Marketing Medicines through Randomised Controlled Trials: The Case of Interferon' (1998) 317 BMJ 1231-3, 1233.
234. In the same way, there is a need to approach research about environmental impacts and climate change sponsored by resource companies - such as coal mining coalitions - and manufacturers - such as automobile makers - with caution.
235. Consider L Glantz and G Annas, 'The FDA, Preemption, and the Supreme Court' (2008) 358 NEJM 1883-5.
236. M Berger, 'Eliminating General Causation: Notes Towards a New Theory of Justice and Toxic Torts' (1997) 97 Columbia Law Rev 2117-52, 2131;
237. M Berger, 'Upsetting the Balance between Adverse Interests: The Impact of the Supreme Court's Trilogy on Expert Testimony in Toxic Tort Litigation' (2001) 64 Law Contemp Prob 289-326;
238. Cranor (n 107).
239. Ibid 2134.
240. S Krimsky, 'The Funding Effect in Science and its Implications for the Judiciary' (2005) 13 J Law Pol 43-68.
241. G Edmond, 'Supersizing Daubert: Science for Litigation and its Implications for Legal Practice and Scientific Research' (2007) 52 Villanova Law Rev 857-924.
242. I am not arguing that independence produces objective knowledge or even particularly reliable knowledge, nor that all reliable scientific research is independent. What I am suggesting is that in legal contexts remoteness from sponsorship, in conjunction with transparency, will help with the assessment of expert evidence and biomedical research. On average, these heuristics will be of more utility and exert greater disciplinary force than focusing on the bare fact of publication in a peer-reviewed journal. There is, however, a need to pay attention to the reliability of expert evidence even where that is not the admissibility standard. See M Redmayne, Expert evidence and criminal justice (OUP, Oxford 2001);
243. G Edmond, 'Specialised Knowledge, the Exclusionary Discretions and Reliability: Reassessing Incriminating Expert Opinion Evidence' (2008) 31 Univ NSW Law J 1-55.
244. Requiring better evidence from manufacturers in discovery and litigation may afford better protection than our existing regulatory and tort frameworks. For some of their limitations, see P Cane, 'Reforming Tort Law in Australia: A Personal Perspective' (2003) 27 Melbourne Univ Law Rev 649-6.
245. S Hilgartner, Science on Stage: Expert Advice as Public Drama (Stanford University Press, Stanford 2000).
246. These kinds of questions need to be asked of potential judges (and jurors).
247. Rampton and Stauber (n 71);
248. Abraham and LawtonSmith (n 106);
249. A Rich, Think Tanks, Public Policy and the Politics of Expertise (CUP, Cambridge 2004);
250. S Beder, Global Spin: The Corporate Assault on Environmentalism (Scribe, Melbourne 1997).
251. S Jasanoff, 'Ordering Knowledge, Ordering Society' in S Jasanoff (ed.), States of Knowledge: The Co-Production of Science and the Social Order (Routledge, New York 2004).
252. I Chalmers, 'Unbiased, Relevant, and Reliable Assessments in Healthcare' (1998) 317 BMJ 1167-8.