The Vioxx story: Would it have ended differently in the European Union?

American Journal of Law and Medicine

Volumn 32, Issue 2-3, 2006, Pages 365-380

  Thomas, W John ^a,b,c  

^a QUINNIPIAC UNIVERSITY   (United States)

^b UNIVERSITY OF ARIZONA   (United States)

^c YALE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTIINFECTIVE AGENT; CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; NONSTEROID ANTIINFLAMMATORY AGENT; ROFECOXIB; SULFANILAMIDE;

CARDIOVASCULAR DISEASE; CLINICAL TRIAL; DRUG APPROVAL; DRUG EFFECT; DRUG SAFETY; EUROPEAN UNION; FEVER; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; INFECTION; OSTEOARTHRITIS; PAIN; REVIEW; STOMACH HEMORRHAGE; STOMACH PAIN;

EID: 33748117580     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880603200210     Document Type: Review

References (160)

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4. Id.
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23. Curfman et al., supra note 21, at 26.
24. Vioxx Case Leads to Hung Jury, supra note 20.
25. Id. "This respected journal issuing a critique of Merck's behavior is especially important to a jury who now sees Merck as a company that doctors studies." Id.
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28. Id.
29. Id.
30. Id.
31. Id.
32. Id.
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50. Id.
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53. Id.
54. Id. (quoting Daniel Solomon, Assistant Professor of Medicine, Harvard Medical School, lead author on the Circulation study).
55. Merck: Officials Ignored Conclusion about Death in Vioxx Trial, 10 AM. HEALTH LINE (The Advisory Board Company, Washington, D.C.) April 25, 2005. In a May 1, 2005 letter to New York Times editor, Kenneth C. Frazier, Merck's Senior V.P. and General Counsel, questioned the import of selected, internal email messages "Internal discussions plucked from selected e-mail messages provided by 'a person working with plaintiffs' involved in lawsuits against Merck should in no way detract from the fact that the F.D.A. analyzed the relevant information in its decision on the Vioxx label. Merck's actions were diligent and responsible." Kenneth C. Frazier, Letter to the Editor, N.Y. TIMES, May 1, 2005, at D13.
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58. Id.
59. See id.
60. See id.;
61. Jeffrey R. Lisse et al., Gastrointestinal Tolerability and Effectiveness of Rofecoxib Versus Naproxen in the Treatment of Osteoarthritis - A Randomized, Controlled Trial, 139 ANN. INTERN. MED. 539 (2003).
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66. Expression of Concern, supra note 21.
67. Id.
68. See id;
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75. See id.
76. See id.
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82. See id.
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91. Id.
92. Id.
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94. See Gardiner Harris & Alex Berenson, 10 Voters on Panel Backing Pain Pills Had Industry Ties, N.Y. TIMES, Feb. 25, 2005, at A1.
95. Id.
96. Id. "If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return." Id.
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101. Id.
102. Id. at 854.
103. The Maastricht Treaty, which became effective on November 1, 1993, created the "European Union." Richard F. Kingham, Peter W.L. Bogaert & Pamela Eddy, The New European Medicines Agency, 49 FOOD & DRUG L.J. 301, 301 (1994) (citing, TREATY ON EUROPEAN UNION TOGETHER WITH THE COMPLETE TEXT OF THE TREATY ESTABLISHING THE EUROPEAN COMMUNITY, 1992 O.J. (No. C 224) 1 and the FINAL ACT AND DECLARATIONS ADOPTED BY THE INTERGOVERNMENTAL CONFERENCES IN MAASTRICHT, 1992 O.J. (No. C 191) 1, 95, 109 (Feb. 7, 1992)).
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119. See generally Matthews & Wilson, supra note 109.
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121. Id.
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125. 119 Id.
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137. Id.
138. Gardiner Harris, Official Quits on Pill Delay at the F.D.A., N.Y. TIMES, Sept. 1, 2005, at A12.
139. James Kanter, Free-for-all over generic drugs in Europe Bitter pills/Why Europeans pay what they pay, INT'L HERALD TRIB., Nov. 15, 2005, § Finance, at 3. "The companies that produce branded pharmaceuticals are rich and powerful. They have united with patients seeking access to their drugs and have helped finance groups that lobby for patients' rights." Id.
140. Permanand & Mossialos, supra note 127, at 35.
141. Id. at 19.
142. Id. at 38.
143. See supra text accompanying note 1.
144. Matthews & Wilson, supra note 109, at 424.
145. Id.
146. Id.
147. See, e.g., Catherine T. Struve, The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation, YALE J. HEALTH POL'Y L. & ETHICS 587 (2005) (discussing the FDA's various enforcement powers).
148. See supra text accompanying notes 108-114.
149. Permanand & Massiolos, supra note 127, at 23.
150. See id.
151. Id. at 23-24.
152. See supra text accompanying note 129.
153. U.S. Food & Drug Admin. FDA's Mission Statement, http://www.fda.gov/ opacom/morechoices/mission.html (last visited February 27, 2006).
154. Permanand & Massiolos, supra note 127, at 4.
155. Orzack, Kaitin & Lasagna, supra note 94, at 863.
156. See discussion supra Part V.
157. Philip Gailey, Can't Take the Politics out of Elections, Even for Judges, ST. PETERSBURG TIMES, August 18, 2002 (quoting a "Georgia legislator"), available at http://www.sptimes.com/2002/08/18/Columns/ Can_t_take_the_politi.shtml.
158. See discussion supra pp. 10-11.
159. Senators Chuck Grassley (Republican, Iowa) and Chris Dodd (Democrat, Conn.). S. 930, to Amend the Federal Food, Drug, and Cosmetic Act with Respect to Drug Safety, and for Other Purposes, 109th CONGRESS, 1st Session.
160. Id.