1. | Lexchin J., , “Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review,” BMJ 326, no. 31 (2003): 1167–1170; Steinman M. A., , “Characteristics and Impact of Drug Detailing for Gabapentin,” PLoS Medicine 4, no. 4 (2007): 743–751; Hill K. P., , “The ADVANTAGE Seeding Trial: A Review of Internal Documents,” Annals of Internal Medicine 149, no. 4 (2008): 251–258; Ross J. S., , “Guest Authorship and Ghostwriting in Publications Related to Rofecoxib,” JAMA 299, no. 15 (2008): 1800–1812; Sismondo S., “How Pharmaceutical Industry Funding Affects Trial Outcomes: Causal Structures and Responses,” Social Science & Medicine 66, no. 9 (2008): 1909–1914; Spurling G., , “Information from Pharmaceutical Companies and the Quality, Quantity and Cost of Physicians' Prescribing: A Systemiatic Review,” PLoS Medicine 7, no. 10 (2010): E1000352; Lexchin J., “Those
Who Have the Gold Make the Evidence: How the Pharmaceutical Industry
Biases the Outcomes of Clinical Trials of Medications,” Science and Engineering Ethics 18, no. 2 (2012): 247–261; Vedula S., Li T., Dickersin K., “Differences
in Reporting of Analyses in Internal Comany Documents Versus Published
Trial Reports: Comparisions in Industry-Sponsored Trials in Off-Label
Uses of Gabapentin,” PLoS Medicine 10, no. 1 (2013): E1001378. Google Scholar Crossref, Medline |
2. | Thompson D., “Two Concepts of Corruption,” in Working Papers (Safra Edmond J. Center for Ethics: Harvard University, 2010); Lessig L., Republic, Lost: How Money Corrupts Congress - and a Plan to Stop It (New York: Twelve/Hachette, 2011); Thompson D., Ethics in Congress: From Individual to Institutional Corruption (Washington, D.C.: Brookings Institution, 1984); see also Lessig L., “Institutional Corruptions,” in Research in Action Working Papers, Safra Edmond J. Center for Ethics (Cambridge, MA: Research in Action Working Papers, Safra Edmond J. Center for Ethics, Harvard University, 2013). Quotations are from Republic, Lost. Google Scholar |
3. | See Republic, Lost, supra note 2, at 285. Google Scholar |
4. | Light D. W., “Strengthening the Theory of Institutional Corruptions: Broadening, Clarifying, Measuring,” in Research in Action Working Paper, Lessig L., Somos M., eds. (Safra Edmond J. Center for Ethics: Harvard University, 2013). Google Scholar Crossref |
5. | Salter M., “Lawful but Corrupt: Gaming and the Problem of Institutional Corruption in the Private Sector,” in Harvard Business School Working Papers (Boston: Harvard Business School, 2009). Google Scholar |
6. | Beauchamp T., Childress J., Principles of Bioethical Ethics, 5th ed. (New York: Oxford University Press, 2001); Gillon R., “Medical Ethics: Four Principles Plus Attention to Scope,” BMJ 309, no. 6948 (1994): 184. Google Scholar |
7. | See Purposeful Identity, “Merck & Company,” available at <http://www.purposefulidentity.com/values-mission-value-drivers-vision/mission-statement-2011/Merck-Healthcare-Support-Services-industry-104.html> (last visited June 20, 2013). Missions of Pfizer and other companies can be found at the website as well. Google Scholar |
8. | JFor a discussion of the misalignment between market incentives and public health goals, and ways to address that problem, see Gagnon M.-A., “Corruption of Pharmaceutical Markets: Addressing the Misalignment of Financial Incentives and Public Health,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 571–580. See also in JLME 41, no. 3 (2013): Rodwin M., “Five Un-Easy Pieces to Pharmaceutical Policy Reform,” 581–589, and Sismondo S., “Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will and Won't Cast Light On,” 635–643. Google Scholar Link |
9. | See Republic, Lost, supra note 2, at 107–116. Google Scholar |
10. | King M., Bearman P., “Conflict of Interest Policies and the Diffusion of Stimulant, Antidepressant, and Antipsychotic Medications,” in American Sociological Association (New York City: Yale University School of Management, 2013). Google Scholar |
11. | Young J. H., The Toadstool Millionaires: A Social History of Patent Medicines in America before Federal Regulation (Princeton, NJ: Princeton University Press, 1961); Hilts P. J., Protecting America's Health: The FDA, Business and One Hundred Years of Regulation (New York: Alfred A. Knopf, 2003). Google Scholar |
12. | See Hilts, supra note 11; Zelenay J., “The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?” Food and Drug Law Journal 60, no. 2 (2005): 261–338. Google Scholar Medline |
13. | Angell M., The Truth About the Drug Companies: How They Deceive Us and What to Do About It (New York: Random House, 2004); Avorn J., Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (New York: Knopf, 2004); Goozner M., The $800 Million Pill: The Truth Behind the Cost of New Drugs (Berkeley: University of California Press, 2004). Google Scholar |
14. | Light D., Lexchin J., “Pharmaceutical R&D - What Do We Get for All That Money?” BMJ 344, no. 7869 (2012): e4348. Google Scholar Crossref |
15. | Light D. W., Lexchin J., “Foreign Free Riders and the High Price of US Medicines,” BMJ 331, no. 7522 (2005): 958–960; National Science Foundation, “Research and Development in Industry: 1999” (Arlington: March 2002). Google Scholar Crossref |
16. | Gagnon M.-A., Lexchin J., “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” PLoS Medicine 8, no. 1 (2008): 1–5. Google Scholar Crossref |
17. | Prescrire Editorial Staff, “Drugs in 2001: A Number of Ruses Unveiled,” Prescrire International 11, no. 58 (2002): 58–60. Google Scholar Medline |
18. | Prescrire Editorial Staff, “New Drugs and Indications in 2011,” Prescrire International 21, no. 126 (2012): 106–110. Google Scholar Medline |
19. | Lexchin J., “International Comparison of Assessments of Pharmaceutical Innovation,” Health Policy 105, nos. 2–3 (2012): 221–225. Google Scholar Crossref, Medline |
20. | See Light, Lexchin, supra note 14. Google Scholar |
21. | O'Reilly E., “IND Preparation and Maintenance,” Duke Translational Medicine Institute, available at <http://tracs.unc.edu/docs/regulatory/IND_Presentation-IND_Preparation_and_Maintenance-Best_Practices.ppt> (last visited June 20, 2013); Schmid E., Smith D., “Is Declining Innovation in the Pharmaceutical Industry a Myth?” Drug Discovery Today 10, no. 15 (2005): 1031–1039. Google Scholar |
22. | Steinman M. A., , “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,” Annals of Internal Medicine 145, no. 4 (2006): 284–293; Hoffman M., “Pharmaceutical Detailing Is Not for Everyone,” Journal of Legal Medicine 33, no. 3 (2012): 381–397; Spurling G., , “Information from Pharmaceutical Companies and the Quality, Quantity and Cost of Physicians' Prescribing: A Systemiatic Review,” PLoS Medicine 7, no. 10 (2010): e1000352; see also Sah S., Fugh-Berman A., “Physicians under the Influence: Social Psychology and Industry Marketing Strategies,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 665–672. Google Scholar Crossref, Medline |
23. | See Avorn, supra note 13, at Chapter 13; Morgan S. G., , “‘Breakthrough’ Drugs and Growth in Expenditure on Prescription Drugs in Canada,” BMJ 331, no. 7520 (2005): 815–816. Google Scholar Crossref, Medline |
24. | See Light, Lexchin, supra note 14. Google Scholar |
25. | See Avorn, supra note 13, at 205, 197–216. Google Scholar |
26. | Lazarou J., Pomeranz B. H., Corey P. N., “Incidence of Adverse Drug Reactions in Hospitalized Patients,” Journal of American Medical Association 279, no. 15 (1998): 1200–1205. Google Scholar Crossref |
27. | Other recent studies find similar rates of harm. van der Hooft C., , “Adverse Drug Reaction Related Hospitalizations,” Drug Safety 29, no. 2 (2006): 161–168; Pirmohamed M., , “Adverse Drug Reactions as Cause of Admission to Hospital: Prospecive Analysis of 18,820 Patients,” BMJ 329, no. 7456 (2004): 15–19. Google Scholar Crossref, Medline |
28. | ISMP, “QuarterWatch,” Moore T. J., Cohen M. R., Furberg C. D., eds. (Horsham, PA: Institute for Safe Medication Practices, 2012). Google Scholar |
29. | Lexchin J., “New Drugs and Safety: What Happened to New Active Substances Approved in Canada between 1995 and 2010?” Archives of Internal Medicine 172, no. 21 (2012): 1680–1681. Google Scholar Crossref, Medline |
30. | Kaiser Family Foundation, Prescription Drug Trends, 2010. Google Scholar |
31. | Moore T., Prescription for Disaster (New York: Simon & Schuster, 1998); Goodnough A., Zezima K., “Drivers on Prescription Drugs: Dangerous, but Hard to Convict,” New York Times, July 25, 2010. Google Scholar |
32. | See Avorn, supra note 13. Google Scholar |
33. | Gagnon M.-A., Lexchin J., “The Cost of Pushing Pills: A New Estimate of pharmaceutical promotion expenditures in the United States,” PLoS Medicine 5, no. 1 (2008); Applbaum K., “Getting to Yes: Corporate Power and the Creation of a Psychopharmaceutical Blockbuster,” Culture, Medicine and Psychiatry 33, no. 2 (2009): 185–215; Applbaum K., “Is Marketing the Enemy of Pharmaceutical Innovation?” Hastings Center Report 39, no. 4 (2009): 13–17.
For excellent overviews of how dependency corruption compromises the
medical profession's duty to make patients as healthy as they can be,
see Rodwin M., “Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform,” Journal of Law, Medicine & Ethics 40, no. 3 (2012): 511–522; Rodwin M., “Reforming Pharmaceutical Industry-Physician Financial Relationships: Lessons from the United States, France, and Japan,” Journal of Law, Medicine & Ethics 39, no. 4 (2011): 662–670. Google Scholar Crossref |
34. | See Young, supra note 11; Hilts, supra note 11. Google Scholar |
35. | See Hilts, supra note 11, at 79–90. Google Scholar |
36. | Id., at 151–156. Google Scholar |
37. | Salter, supra note 5; Salter M., Short-Termism at Its Worst, Safra Edmond J. Center for Ethics Working Paper No. 5, 2013, available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2247545> (last visited June 20, 2013); Salter M., Innovation Corrupted: The Origins and Legacy of Enron's Collapse (Cambridge, MA: Harvard University Press, 2008); Carpenter D., Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton: Princeton University Press, 2010). Google Scholar |
38. | See Hilts, supra note 11, at Chap. 8. This is about what Prescrire has found since 1981 (Figure 1). Google Scholar |
39. | See Republic, Lost, supra note 2, at 107–116. Google Scholar |
40. | See Hilts, supra note 11, at Chap. 11. Google Scholar |
41. | Food and Drug Administration, “Guidance for FDA Staff and Industry:
Marketed Unapproved Drugs: Compliance Policy Guide,” September 19, 2011, at 3, 10–11. Google Scholar |
42. | See Hilts, supra note 11; Carpenter, supra note 37. Google Scholar |
43. | Id. (Hilts); Abraham J., Science, Politics and the Pharmaceutical Industry (London: Routledge, 1995); Rodwin M., “Independent Clinical Trials to Test Drugs: The Neglected Reform,” St. Louis Law Review 6, no. 113 (2012): 113–166. Google Scholar |
44. | U.S. Government Accounting Office, “New Drug Approvals: FDA Needs to
Enhance its Oversight of Drugs Approved on the Basis of Surrogate
Endpoints,” Washington, D.C., 2009; Avorn J., “Approval of a Tuberculosis Drug Based on a Paradoxical Surrogate Measure,” JAMA 309, no. 13 (2013): 1349–1350. Google Scholar |
45. | Garattini S., Bertele V., “Non-Inferiority Trials Are Unethical Because They Disregard Patients' Interests,” The Lancet 370, no. 9602 (2007): 1875–1877. Google Scholar Crossref, Medline |
46. | Garattini S., Bertele V., “Efficacy, Safety, and Cost of New Anticancer Drugs,” BMJ 325, no. 7358 (2002): 269–271; Garattini S., Bertele V., “Ethics in Clinical Research,” Journal of Hepatology 51, no. 4 (2009): 792–797; Garattini S., Bertele V., “Europe's Opportunity to Open Up Drug Regulation,” BMJ 340, no. 30 (2010): 842–843; Fisher J. A., Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (New Brunswick: Rutgers University Press, 2009); Fisher J. A., “United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study,” PLoS Medicine 9, no. 7 (2012): E1001271; McGoey L., “On the Will to Ignorance in Bureaucracy,” Economy and Society 36, no. 2 (2007): 212–235. Google Scholar Crossref |
47. | Zimmerman M., Mattia J., Posternak M. A., “Are Subjects in Pharmacologocal Treatment Trials of Depression Representative of Patients in Routine Clinical Practice,” American Journal of Psychiatry 159, no. 3 (2002): 469–473; Travers J., , “External Validity of Randomised Controlled Trials in Asthma: To Whom Do the Resuls of the Trials Apply?” Thorax 62, no. 3 (2007): 219–223. Google Scholar Crossref, Medline |
48. | Applbaum K., “Is Marketing the Enemy of Pharmaceutical Innovation?” The Hasting Center Report 39, no. 4 (2009): 13–17; Sismondo S., “Ghost Management,” PLoS Medicine 4, no. 9 (2007): 1429–1433; see Sismondo, supra note 8; Hart B., Lundh A., Bero L., “Effect of Reporting Bias on Meta-Analyses of Drug Trials: Reanalysis of Meta-Analyses,” BMJ 344, no. 7838 (2012): d7202; Lexchin (2012), supra note 1. Google Scholar Crossref, Medline |
49. | Lundh A., , “Industry Sponsorship and Research Outcome (Review),” Cochrane Database of Systematic Reviews no. 12 (2012). Google Scholar Crossref, Medline |
50. | Rennie D., “When Evidence Isn't: Trials, Drug Companies and the FDA,” Journal of Law and Policy 15, no. 3 (2007): 991–1012; Prakash S., “Did Merck Try to Censor Vioxx Critics?” National Public Radio, June 9, 2005; Prakash S., “Conflicted Safety Panel Let Vioxx Study Continue,” National Public Radio, June 8, 2006; Goldacre B., Bad Pharma: How Drug Companies Mislead Doctors and Harm (London: Faber & Faber, 2012). Google Scholar |
51. | See Rennie, supra note 50, at 1001. Google Scholar |
52. | See Zelenay, supra note 12. Google Scholar |
53. | Munos B., “Lessons from 60 Years of Pharmaceutical Innovation,” Nature Reviews Drug Discovery 8, no. 12 (2009): 959–968. Google Scholar Crossref, Medline |
54. | Olson M. K., “Are Novel Drugs More Risky for Patients Than Less Novel Drugs?” Journal of Health Economics 23, no. 6 (2004): 1135–1158. Google Scholar Crossref, Medline |
55. | Carpenter D., “Corrosive Culture? The Dueling Forces of Autonomy and Industry Influence in FDA Pharmaceutical Regulation,” in Preventing Regulatory Capture: Social Influence and How to Limit It, Carpenter D., Moss D., eds., (New York: Cambridge University Press, 2013): At Chap. 6; Hamburg M., “Innovation, Regulation, and the FDA,” New England Journal of Medicine 363, no. 23 (2010): 2228–2232. For telling details, see Rodwin, supra note 43, and Rodwin M., “Drug Advertising, Continuing Medical Education, and Physician Prescribing: An Historical Review and Reform Proposal,” Journal of Law, Medicine & Ethics 38, no. 4 (2010): 807–815. Google Scholar Crossref |
56. | Carpenter D., , “The Complication of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety,” American Journal of Political Science 56, no. 1 (2012): 98–114. Google Scholar Crossref, Medline |
57. | U.S. Office of the Inspector General, FDA's Review Process for New Drug Applications: A Management Review, 2003. Google Scholar |
58. | See Carpenter, supra note 56, at 99. Google Scholar |
59. | Wood A., Stein C. M., Woosley R., “Making Medicines Safer - The Need for an Independent Drug Safety Board,” New England Journal of Medicine 339, no. 25 (1998): 1851–1854; see also Hilts, supra note 11; Moore T., Deadly Medicine: Why Tens of Thousands of Heart Patients Died in America's Worst Drug Disaster (New York: Simon & Schuster, 1995). Google Scholar Crossref |
60. | See Zelenay, supra note 12. Google Scholar |
61. | On REMS, see Walker S., “Maximizing REMS Potential,” Drug Topics 156, no. 9 (2012). On the Sentinel system, see Racoosin J., , “FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals,” in Strom B. L., Kimmel S. E., Hennessy S., eds., Pharmacoepidemiology (New York: Wiley Online Library, 2012); Savage N., “Digging for Drug Facts,” Communications of the ACM 55, no. 10 (2010). On AERS, see Weiss-Smith S., “The FDA Drug Safety Surveillance Program: Adverse Event Reporting Trends,” Archives of Internal Medicine 171, no. 6 (2011): 591–593. Google Scholar |
62. | See 21 U.S.C. § 379h(b)(1)(A) (2013). Google Scholar |
63. | See Lexchin, supra
note 29. The poorer safety record for priority drugs cannot be
explained by the importance of the diseases they treat or the mechanisms
by which they work. Google Scholar |
64. | Prescrire Editorial Staff, supra note 18. Google Scholar |
65. | Weissman R., “From FDA, a Warning,” Boston Globe, March 16, 2013, at B5. Google Scholar |
66. | See Zelenay, supra note 12. Google Scholar |
67. | Angell M., “Taking Back the FDA,” Boston Globe, February 26, 2007. Google Scholar |
68. | See Rennie, supra note 50, at 1006; Lemmens T., “Pharmaceutical Knowledge Governance: A Human Rights Perspective,” Journal of Law, Medicine & Ethics 41, no. 1 (2013): 163–184. Google Scholar Link |
69. | Brody H., Light D. W., “The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health,” American Journal of Public Health 101, no. 3 (2011): 399–404; Healy D., Pharmageddon (Berkeley: University of California Press, 2012); see Goldacre, supra note 50. Google Scholar Crossref |
70. | Mintzes B., , “Pharmaceutical
Sales Representatives and Patient Safety: A Comparative Prospective
Study of Information Quality in Canada, France and the United States,” Journal of General Internal Medicine (forthcoming 2013); Prescrire Editorial Staff, “15 Years of Monitoring and One Simple Conclusion: Don't Expect Sales Representatives to Help Improve Healthcare Quality,” Prescrire International 15, no. 84 (2006): 154–159. Google Scholar |
71. | U.S. Government Accounting Office, “Prescription Drugs: FDA's Oversight
of the Promotion of Drugs for Off-Label Uses,” Washington, D.C., 2008; Kiester M., “DDMAC submissions,” FDA, available at <http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM246563.pdf> (last visited June 20, 2013). Google Scholar |
72. | Nguyen D., , “Changes
in FDA Enforcement Activities Following Changes in Federal
Administration: The Case of Regulatory Letters Released to
Pharmaceutical Companies,” BMC Health Services Research 13 (2013): 27. Google Scholar Crossref, Medline |
73. | Krumholz S., Egilman D., “Study of Neurontin: Ittrate to Effect, Profile of Safety (STEPS) Trial: A Narrative Account of a Gabapentin Seeding Trial,” Archives of Internal Medicine 171, no. 12 (2011): 1100–1107. Google Scholar Crossref, Medline |
74. | Eguale T., , “Drug, Patient, and Physician Characteristics Associated with Off-Label Prescribing in Primary Care,” Archives of Internal Medicine 172, no. 10 (2012): 781–788; Radley D. C., Finkelstein S. N., Stafford R. S., “Off-Label Prescribing among Office-Based Physicians,” Archives of Internal Medicine 166, no. 9 (2006): 1021–1026. Google Scholar Crossref, Medline |
75. | For more detail, see Rodwin (2012), supra note 33, and Rodwin M. A., “Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 654–664. Google Scholar Link |
76. | Waxman H., “Prescription for Harm: The Decline in FDA Enforcement Activity,” in Special Investigations Division (Washington, D.C.: Committee on Government Reform, U.S. House of Representatives, 2006). Google Scholar |
77. | See Rennie, supra note 50; Rodwin, supra note 43. Google Scholar |
78. | Id. (Rodwin), at 130–159. Google Scholar |
79. | See Open Secrets, available at <http://www.opensecrets.org/lobby/indusclient.php?id=H04> (last visited June 20, 2013). Google Scholar |
80. | See Rodwin, supra note 43; Abraham, supra note 43; Abraham J., Davis C., “Deficits, Expectations, and Paradigms in British and American Drug Safety Assessment,” Science Technology Human Values 32, no. 4 (2007): 399–431; Abraham J., “Drug Evaluation and the Permisive Principle,” Social Studies of Science 39, no. 4 (2009): 569–598. Google Scholar Link |
81. | Warburton R., “What Do We Gain from the Sixth Coronary Heart Disease Drug?” BMJ 327, no. 7426 (2003): 1237–1238. Google Scholar Crossref, Medline |
82. | Dukes M., Lunde I., “The Regulatory Control of Non-Steroidal Anti-Inflammatory Agents,” European Journal of Clinical Pharmacology 19, no. 1 (1981): 3–10. Google Scholar Crossref, Medline |
83. | See Garattini, Bertele, supra note 45. Google Scholar |
84. | Rodwin M., Abramson J., “Clinical Trial Data as a Public Good,” JAMA 308, no. 9 (2012): 871–872; supra note 68; Duijnhaven R., , “Number of Patients Studied Prior to Approval to New Medicines: A Database Analysis,” PLoS Medicine 10, no. 3 (2013): e1001407. Google Scholar Crossref, Medline |
85. | See Republic, Lost, supra note 2, at Part IV. Google Scholar |
No comments:
Post a Comment