Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles

1. LemmensT 2004 Leopards in the temple: restoring scientific integrity to the commercialized research scene. JL Med Ethics 32 641 657

2. GøtzschePCKassirerJPWoolleyKLWagerEJacobsA 2009 What should be done to tackle ghostwriting in the medical literature? PLoS Med 6 e23 doi:10.1371/journal.pmed.1000023

3. SismondoS 2009 Ghosts in the machine: publication planning in the medical sciences. Soc Stud Sci 39 171 198

4. MathesonA 2008 Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 3 355 382

5. HealyDCattellD 2003 Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry 183 22 27

6. RossJSHillKPEgilmanDSKrumholzHM 2008 Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 299 1800 1812

7. Fugh-BermanAJ 2010 The haunting of medical journals: how ghostwriting sold ‘HRT.’ PLoS Med 7 e1000335 doi:10.1371/journal.pmed.1000023

8. JureidiniJNMcHenryLBMansfieldPR 2008 Clinical trials and drug promotion: Selective reporting of Study 329. The International Journal of Risk and Safety in Medicine 20 183 183

9. JohnsonKRLassereMND 2008 Guest authorship, mortality reporting, and integrity in rofecoxib studies. JAMA 300: 900; author reply 904-906

10. FlanaginACareyLAFontanarosaPBPhillipsSGPaceBP 1998 Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 280 222 224

11. SmithR 2005 Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med 2 e138 doi:10.1371/journal.pmed.0020138

12. MoffattBElliottC 2007 Ghost marketing: pharmaceutical companies and ghostwritten journal articles. Perspect Biol Med 50 18 31

13. GøtzschePCHróbjartssonAJohansenHKHaahrMTAltmanDG 2007 Ghost authorship in industry-initiated randomised trials. PLoS Med 4 e19 doi:10.1371/jour-nal.pmed.0040019

14. United States Senate Committee on Finance 2010 Ghostwriting in medical literature minority staff report, 111th Congress, Sen. Charles E. Grassley, Ranking Member. p

15. BiagioliM 2000 Rights or rewards? changing contexts and definitions of scientific authorship. Journal of College and University Law 27 83 108

16. EdmondG 2008 Judging the scientific and medical literature: some legal implications of changes to biomedical research and publication. Oxford Journal of Legal Studies 28 523 561

17. Daubert v. Merrell Dow Pharmaceuticals. 509 U.S. 579 1993

18. LexchinJ 2003 Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326 1167 1170

19. BekelmanJELiYGrossCP 2003 Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 289 454 465

20. SchottGPachlHLimbachUGundert-RemyU Ludwig W-D, et al. 2010 The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials. Dtsch Arztebl Int 107 279 285

21. SchottGPachlHLimbachUGundert-RemyULiebK 2010 The financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication. Dtsch Arztebl Int 107 295 301

22. CaplovitzA 2006 Turning medicine into snake oil, how pharmaceutical marketers put patients at risk. Boston and Washington (D.C.) U.S. PIRG

23. International Committee of Medical Journal 2009 Uniform requirements for manuscripts submitted to biomedical journals: ethical considerations in the conduct and reporting of research: authorship and contributorship. Available: http://www.icmje.org/ethical_1author.html. Accessed 3 Apr 2011

24. World Association of Medical 2005 Ghost writing initiated by commercial companies. Available: http://www.wame.org/resources/policies#ghost. Accessed 30 June 2011

25. Committee on Publication Ethics (COPE) 2011 COPE code of conduct. Available: http://www.publicationethics.org/files/Code_of_conduct_for_journal_editors_Mar11.pdf. Accessed 30 June 2011.

26. The PLoS Medicine 2009 Ghostwriting: the dirty little secret of medical publishing that just got bigger. PLoS Med 6 e1000156 doi:10.1371/journal.pmed.1000156

27. McHenryLBJureidiniJ 2008 Industry-sponsored ghostwriting in clinical trial reporting: a case study. Accountability in Research 15 3 152 167

28. SmithR 2006 Lapses at the New England journal of medicine. J R Soc Med 99 380 382

29. SismondoS 2007 Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 4 e286 doi:10.1371/journal.pmed.0040286

30. MoffatB 2011 Responsible authorship: why researchers must forgo honorary authorship. Account Res 18 2 76 90

31. BatyP 10 November 2009 Academic made ‘untrue’ declaration about ‘full access’ to research material, GMC finds. Times Higher Education. Available: http://www.timeshighereducation.co.uk/story.asp?storycode=409013. Accessed 3 April 2011.

32. IrvineD 2006 A short history of the General Medical Council. Medical Education 40 3 202 211 doi:10.1111/j.1365-2929.2006.02397.x

33. PicardA 19 August 2007 Does self-regulation work for the medical profession? The Globe and Mail Available: http://www.theglobeandmail.com/life/article775586.ece. Accessed 30 June 2011.

34. LacasseJRLeoJ 2011 Knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research. BMC Research Notes 4 27

35. Rakesv Life Investors Ins. Co. of America, 582 F.3d 886 (8th Cir 2009)

36. R. v. Théroux, [1993] 2 S.C.R. 5 [Canada]; Magill v. Magill, 2006 231 A.L.R. 277 (HC) [Australia]; Barlow Clowes International Ltd v Eurotrust International Ltd (2005) [United Kingdom]; Commissioner of Customs (Preventive) v. Aafloat Textiles (I) P. Ltd. 2009 (235) E.L.T. 587 (S.C.) [India]

37. EdmondG 2007 Supersizing Daubert science for litigation and its implications for legal practice and scientific research. Villanova Law Review 52 857 924

38. 31 U.S.C. § 3729

39. Strom ex rel. U.S. v. Scios, Inc., 676 F. Supp.2d 884 (N.D. Cal. 2009)

40. 18 U.S.C. § 2

41. 18 U.S.C. §§ 1961-62

42. Sedima, S.P.R.L. v. Imrex Co., 473 U.S. 479 (1985)

43. Am. Nat'l Bank & Trust Co. v. Haroco, Inc., 473 U.S. 606 (1985)

44. Holmes v. Sec. Investor Prot. Corp., 503 U.S. 258 (1992)

45. Bridge v. Phoenix Bond & Indemnity Co., 128 S. Ct. 2131 (2008)

46. R. v. Stoltz 1993 84 C.C.C. (3d) 422 (B.C.C.A.) [Canada]; S.P. Chengalvaraya Naidu v. Jagannath, [1994] 1 S.C.C. 1 [India]; McDonald v. McDonald (1965), 39 A.J.L.R. 179 (H.C.) [Australia]; Ul-Haq v. Shah [2010], 1 All E.R. 73 (C.A.) [U.K.]

47. Johnsonv Bell, 605 F.3d 333 (6th Cir 2010)

48. Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944)

49. Hatch v. Ooms, 69 F. Supp. 788 (D.D.C.1947), rev'd sub nom. Dorsey v. Kingsland, 173 F.2d 405 (D.C. Cir. 1949), rev'd, 338 U.S. 318 (1949)