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Doubt Is Their Product References: Chapter Twelve
 

1. Angell M. The Truth about the Drug Companies: How They Deceive Us and What to Do about It. New York: Random House, 2004.

2. Abramson J. Overdosed America: The Broken Promise of American Medicine. New York: HarperCollins, 2004.

3. Goozner M. The $800 Million Pill: The Truth behind the Cost of New Drugs. Los Angeles, CA: University of California Press, 2004.

4. Avorn J. Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. New York: Knopf, 2004.

5. Kassirer JP. On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health. New York: Oxford University Press, 2005.

6. Krimsky S. Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? Lanham, MD: Rowman and Littlefield, 2003.

7. Krimsky S. The funding effect in science and its implications for the judiciary. J Law Policy. 2005;13(1):46–68.

8. Rochon PA, Gurwitz JH, Simms RW et al. A study of manufacturer supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med. 1994;154(2):157–63.

9. Stelfox HT, Chua G, O’Rourke K et al. Conflict of interest in the debate over calcium-channel antagonists. NEJM. 1998;338(2):101– 06.

10. Vandenbroucke JP, Helmerhorst FM, Rosendaal FR. Competing interests and controversy about third generation oral contraceptives: BMJ readers should know whose words they read. BMJ. 2000;320(7231):381–82.

11. Montgomery JH, Byerly M, Carmody T et al. An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia. Control Clin Trials. 2004;25(6):598–612.

12. Koepp R, Miles SH. Meta-analysis of tacrine for Alzheimer disease: The influence of industry sponsors. JAMA. 1999;281(24):2287–88.

13. Knox KS, Adams JR, Djulbegovic B et al. Reporting and dissemination of industry versus non-profit sponsored economic analyses of six novel drugs used in oncology. Ann Oncol. 2000;11(12):1591–95.

14. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289(4):454–65.

15. Lexchin J, Bero LA, Djulbegovic B et al. Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ. 2003;326(7400):1167–70.

16. Mandelkern M. Manufacturer support and outcome. J Clin Psychiatry. 1999;60(2):122–23.

17. Yaphe J, Edman R, Knishkowy B et al. The association between funding by commercial interests and study outcome in randomized controlled drug trials. Fam Pract. 2001;18(6):565–68.

18. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005;2(5):0364–66.

19. Rochon PA, Berger PB, Gordon M. The evolution of clinical trials: Inclusion and representation. CMAJ. 1998;159(11):1373–74.

20. Wolfe SM, Sasich LD (Public Citizen’s Health Research Group). Letter to Jefferys D (director, Licensing Division, Medicines Control Agency, United Kingdom). August 27, 1998. HRG publication no. 1454. Available at: http://www.citizen.org/publications/release.cfm?ID=6652. Accessed in June 2007.

21. Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. NEJM. 2000;343(21):1520–28.

22. Mukherjee D, Nissen SE, Topol EJ. Lack of cardioprotective effect of naproxen. Arch Intern Med. 2002;162(22):2637; author reply 2638–39.

23. Villalba ML. Statistical reviewing briefing document for the Advisory Committee. 2000. Available at: http://www.fda.gov/OHRMS/DOCKETS/ac/01/briefing/3677b2_04_stats.pdf. Accessed in June 2007.

24. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001;286(8):954–59.

25. Waxman HA (Ranking member, U.S. House Committee on Governmental Reform, minority staff ). Memorandum to Democratic members of Congress. Re: the marketing of Vioxx to physicians. May 5, 2005. Available at: http://www.democrats.reform.house.gov/Documents/20050505114932–41272.pdf. Accessed in June 2007.

26. Singh G. Testimony before the Senate Finance Commitee. November 18, 2004. Available at: http://www.senate.gov/~finance/hearings/testimony/2004test/111804GStest.pdf. Accessed in June 2007.

27. Matthews AW, Martinez B. Warning signs: Emails suggest Merck knew Vioxx’s dangers at early stage; as heart-risk evidence rose, officials played hardball; internal message: ‘‘DODGE!’’; company says ‘‘out of context.’’ Wall Street Journal. November 1, 2004:A1.

28. Bresalier RS, Sandler RS, Quan H et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. NEJM. 2005;352(11):1092–1102.

29. Graham DJ, Campen D, Hui R et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet. 2005;365(9458):475–81.

30. Graham DJ. Testimony before the Senate Finance Committee. November18, 2004. Available at: http://www.senate.gov/~finance/hearings/testimony/2004test/111804dgtest.pdf. Accessed in June 2007.

31. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., ‘‘Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.’’ NEJM. 2000;343:1520–28. NEJM. 2005;353(26):2813–14.

32. Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. NEJM. 2006;354(11):1193.

33. Lagakos SW. Time-to-event analyses for long-term treatments: The APPROVe Trial. NEJM. 2006;355(2):113–17.

34. Tesoriero HW. New Vioxx study may cast doubt on Merck claims. Wall Street Journal. July 3, 2007:D2.

35. Levesque LE, Brophy JM, Zhang B. Time variations in risk of myocardial infarction among elderly users of COX-2 inhibitors. CMAJ. 2006;174(11):1563–69.

36. Psaty BM. Testimony before the Senate Finance Committee. November 18, 2004. Available at: http://www.senate.gov/~finance/hearings/testimony/2004test/111804bptest.pdf. Accessed in June 2007.

37. Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care. 1996;12(2):209–37.

38. Sackett DL, Oxman AD. HARLOT plc: An amalgamation of the world’s two oldest professions. BMJ. 2003;327(7429):1442–45.

39. Bodenheimer T. Uneasy alliance: Clinical investigators and the pharmaceutical industry. NEJM. 2000;342(20):1539–44.

40. Safer DJ. Design and reporting modifications in industry-sponsored comparative psychopharmacology trials. J Nerv Ment Dis. 2002;190(9):583–92.

41. Johansen HK, Gotzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA. 1999;282(18):1752–59.

42. Psaty BM, Weiss NS, Furberg CD. Recent trials in hypertension: Compelling science or commercial speech? JAMA. 2006;295(14):1704–06.

43. Tramer MR, Reynolds DJ, Moore RA et al. Impact of covert duplicate publication on meta-analysis: A case study. BMJ. 1997;315(7109):635–40.

44. Silverstein FE, Faich G, Goldstein JL et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: The CLASS Study: A randomized control trial. JAMA. 2000;284(10):1247–55.

45. Lichtenstein DR, Wolfe MM. COX-2-selective NSAIDs: New and improved? JAMA. 2000;284(10):1297–99.

46. Okie S. Missing data on Celebrex: Full study altered picture of drug. Washington Post. August 5, 2001:A11.

47. Liebeskind DS, Kidwell CS, Sayre JW et al. Evidence of publication bias in reporting acute stroke clinical trials. Neurology. 2006;67(6):973–79.

48. Mitka M. Critics bash HIV vaccine trial analysis. JAMA. 2003;289(12):1491.

49. VaxGen Inc. Press release: VaxGen announces results of its Phase III HIV vaccine trial in Thailand: Vaccine fails to meet endpoints. Issued November 12, 2003. Available at: http://www.secinfo.com/d13Wqv.26C5.d.htm#1stPage. Accessed in June 2007.

50. Lipton E. U.S. cancels order for 75 million doses of anthrax vaccine. New York Times. December 20, 2006.

51. Herper M. FDA Fix no. 1: Pay up. Forbes. January 12, 2005.

52. Institute of Medicine. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: National Academies Press, 2006.

53. U.S. Government Accountability Office. Drug safety: Improvements needed in FDA’s postmarket decision-making and oversight process. March 2006. Report no. GAO-06–402.

54. Carpenter D, Bowers J, Grimmer J et al. Deadline effect in regulatory drug review: a methodological and empirical analysis. Paper prepared for ‘‘Strengthening the FDA’’ workshop of the Project on Scientific Knowledge and Public Policy (SKAPP) at the George Washington University, Washington, DC. March 2007. Available at: http://www.defendingscience.org/newsroom/upload/Carpenter_FDA_Deadlines-2.pdf. Accessed in June 2007.

55. Psaty BM, Burke SP. Protecting the health of the public: Institute of Medicine recommendations on drug safety. NEJM. 2006;355(17):1753–55.

56. Gale EA. Lessons from the glitazones: A story of drug development. Lancet. 2001;357(9271):1870–75.

57. Pope C, Rauber P. Strategic Ignorance: Why the Bush Administration Is Recklessly Destroying a Century of Environmental Progress. San Francisco: Sierra Club Books, 2004.

58. Willman D. The new FDA: Case study: Rezulin. Los Angeles Times. December 20, 2000. Available at: http://www.pulitzer.org/year/2001/investigativereporting/works/rezulin.html. Accessed in June 2007.

59. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Nonprescription Drugs Advisory Committee. Transcript: Meeting on safety issues of phenylpropanolamine (PPA) in over-the-counter drug products. October 19, 2000. Available at: http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3647t1.doc. Accessed in June 2007.

60. Horwitz RI, Brass LM, Kernan WN et al. Phenylpropanolamine and risk of hemorrhagic stroke: Final report of the Hemorrhagic Stroke Project. May 10, 2000.

61. Kernan WN, Viscoli CM, Brass LM et al. Phenylpropanolamine and the risk of hemorrhagic stroke. NEJM. 2000;343(25):1826–32.

62. Kirton W (Bayer US). Email to Glass T, Hammes C, Kosio R, Dex T, Shook C, Schumm R. Subject: CHPA Yale study meeting, 1/21/99. 2000. Available at: http://www.latimes.com/media/acrobat/2004–03/11953872.pdf. Accessed in June 2007.

63. Mundy A, Sack K. A dose of denial: How drug makers sought to keep popular cold and diet remedies on store shelves after their own study. Los Angeles Times. March 28, 2004.

64. Michaels D. Doubt is their product. Sci Am. 2005;292(6):96–101.

65. Giles J. Drug trials: Stacking the deck. Nature Medicine. 2006;440(7082):270–72.

66. Stone MB, Jones ML. Clinical review: Relationship between antidepressant drugs and suicidality in adults. November 17, 2006. Available at: http://www.fda.gov/OHRMS/DOCKETS/AC/06/briefing/2006-4272b1-01-FDA.pdf. Accessed in October 2007.

67. Levenson M, Holland C (Statistical reviewers, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Science, Office of Biostatistics). Statistical evaluation of suicidality in adults treated with antidepressants. November 17, 2006. Available at: http://www.fda.gov/OHRMS/DOCKETS/AC/06/briefing/2006-4272b1-01-FDA.pdf. Accessed in October 2007.

68. U.S. Food and Drug Administration. Public health advisory: Suicidality in children and adolescents being treated with antidepressant medications. Issued October 15, 2004. Available at: http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm. Accessed in June 2007.

69. Saldanha C. Daubert and suicide risk of antidepressants in children. J Am Acad Psych Law. 2005;33(1):123–25.

70. Josefson D. Jury finds drug 80% responsible for killings. BMJ. 2001;322(7300):1446.

71. Cato J. U.S. Jury finds that antidepressant did not cause boy to kill his grandparents. BMJ. 2005;330(7489):438.

72. Chan A, Hrobjartsson A, Haahr MT et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291(20):2457–65.

73. American Medical Association. Press release: AMA recommends that DHHS establish a registry for all U.S. clinical trials. Issued June 15, 2004.

74. DeAngelis CD, Drazen JM, Frizelle F et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. NEJM. 2005;352(23):2436–38.

75. Drazen JM, Wood AJ. Trial registration report card. NEJM. 2005;353(26):2809–11.

76. Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. NEJM. 2005;353(26):2779–87.

77. Chalmers I. From optimism to disillusion about commitment to transparency in the medico-industrial complex. J R Soc Med. 2006;99(7):337–41.

78. Rennie D. Thyroid storm. JAMA. 1997;277(15):1238–43.

79. Kahn JO, Cherng DW, Mayer K et al. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10(6)/L CD4 cell counts: A randomized controlled trial. JAMA. 2000;284(17):2193–2202.

80. Blumenthal D, Campbell EG, Anderson MS et al. Withholding research results in academic life science: Evidence from a national survey of faculty. JAMA. 1997;277(15):1224–28.

81. Davidoff F, DeAngelis CD, Drazen JM et al. Sponsorship, authorship, and accountability. NEJM. 2001;345(11):825–26; discussion 826–27.

82. Brownlee S. Doctors without borders: Why you can’t trust medical journals anymore. Washington Monthly. April 2004.

83. Jones PB, Barnes TR, Davies L et al. Randomized controlled trial of the effect on quality of life of second- vs first-generation antipsychotic drugs in schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1). Arch Gen Psychiatry. 2006;63(10):1079–87.

84. Rosenheck RA. Outcomes, costs, and policy caution. A commentary on the Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1). Arch Gen Psychiatry. 2006;63(10):1074–76.

85. Lurie P. Selling new drugs using smoke and mirrors. Worst Pills, Best Pills News. March 2003:18–70.

86. Meier B. Results of drug trials can mystify doctors through omission. New York Times. July 21, 2004:C1.

87. Harris G. FDA official admits ‘‘lapses’’ on Vioxx. New York Times. March 2, 2005:A15.