Foreword: Sarbanes-Oxley for science

Law and Contemporary Problems

Volumn 69, Issue 3, 2006, Pages 1-20

  Michaels, David ^a  

^a GEORGE WASHINGTON UNIVERSITY   (United States)

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[No Author keywords available]

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EID: 33750134077     PISSN: 00239186     EISSN: 00239186     Source Type: Journal    
DOI: None     Document Type: Editorial

References (139)

1. See, e.g., A Duty to Publish, 4 Nature Med. 1089, 1089 (1998) (listing recent instances in which drug companies tried to suppress the unfavorable results of studies they helped to fund, but the researchers, "acting in the interests of the public," resisted the pressure and published their findings).
2. Id.
3. See generally Stanton A. Glanz et al., The Cigarette Papers 235-87 (1996).
4. See, e.g., Lisa Bero et al., Lawyer Control of the Tobacco Industry's External Research Program: The Brown and Williamson Documents, 274 JAMA 241-47 (1995);
5. Stanton A Glantz et al., Looking Through a Keyhole at the Tobacco Industry: The Brown and Williamson Documents, 274 JAMA 219-24 (1995);
6. Peter Hanauer et al., Lawyer Control of Internal Scientific Research to Protect Against Products Liability Lawsuits: The Brown and Williamson Documents, 274 JAMA. 234-40 (1995).
7. See also Glanz, supra note 3, at 235-87.
8. Press Release, International Labour Organization (ILO) & World Health Organization (WHO), Number of Work Related Accidents and Illnesses Continues to Increase: ILO and WHO Join in Call for Prevention Strategies (Apr. 28, 2005), available at http://www.ilo.org/public/ english/bureau/inf/pr/2005/21.htm.
9. See also Barry I. Castleman, Asbestos: Medical and Legal Aspects 41-132 (2005).
10. See Wendy Wagner & David Michaels, Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research, 30 Am. J.L. & Med. 119, 121-28 (2004).
11. See, e.g., D. Blumenthal et al., Withholding Research Results in Academic Life Science: Evidence from a National Survey of Faculty, 277 JAMA 1224-28 (1997);
12. B. Psaty & D. Rennie, Stopping Medical Research to Save Money: A Broken Pact with Researchers and Patients, 289 JAMA 2128, 2128-31 (2003);
13. D. Rennie, Thyroid Storm, 277 JAMA 1238-43 (1997);
14. S.A. Rosenberg, Secrecy in Medical Research, 334 N. Eng. J. Med. 392, 392-94 (1996).
15. SKAPP, based at the George Washington University School of Public Health, engages scientists in examinations of the nature of science and how it is used and misused in government decisionmaking and legal proceedings. Through empirical research, discussions among scholars, and publications, SKAPP aims to enhance understanding of how knowledge is generated and interpreted. Major funding for SKAPP, and support for this symposium, is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation. The funding is unrestricted; we do not provide our funders the opportunity to review or approve our activities. For more information, see the SKAPP website at http://www.DefendingScience.org.
16. The first Coronado Conference hosted by SKAPP, Scientific Evidence and Public Policy, was held in March 2003. At the conference, the distinguished group of participants examined the use and misuse of scientific evidence in public policy and the implications of the 1993 Supreme Court decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The participants focused on how these issues are worked out in the legal and regulatory arena, with topics that included the meaning of causation, how scientists reach judgments, and whether there is a scientific method. Additional information is available at http://www.DefendingScience.org. In addition, the papers and commentaries presented at the 2003 Coronado Conference have been published in a special supplement to the American Journal of Public Health and are available for downloading from the SKAPP website.
17. See 95 Am. J. Pub. Health 4 (2005).
18. In the public health arena, the Toxic Substances Control Act, 15 U.S.C. §§ 2601-2671 (1976),
19. and the Pure Food and Drug Act, Pub. L. No. 59-384, 34 Stat. § 768 (1906) (codified as amended at 21 U.S.C. 1-15 (1934)), are good examples of these types of legal incentives to create knowledge.
20. Pub. L. No. 107-204, 116 Stat. 745 (2002) (codified as amended in scattered sections of 15 U.S.C.).
21. Sheila Jasanoff, Transparency in Public Science: Purposes, Reasons, Limits, 69 Law & Contemp. Probs. 21 (Summer 2006).
22. See, e.g., Sheila Jasanoff, The Fifth Branch: Science Advisors As Policymakers (1990);
23. Sheila Jasanoff, Science at the Bar: Law, Science and Technology In America (1995). Jasanoff is the Pforzheimer Professor of Science and Technology Studies at the John F. Kennedy School of Government of Harvard University.
24. Jasanoff, supra note 12, at 20.
25. Id. at 29.
26. Id. at 40. Jasanoff further explains reasons for and methods to ensure such safeguards: [S]ome common pathologies of science-based decisionmaking [are] imperfect accountability, asymmetric standards, and excessive transparency.... All three affect the production of reliable scientific knowledge, but all reflect at bottom procedural deficiencies: withholding access from, or in some cases granting it to, the wrong people, at the wrong times, for the wrong purposes.
27. Id.
28. Id. at 42.
29. Susan Haack, Scientific Secrecy and "Spin". The Sad, Sleazy Saga of the Trials of Remune, 69 Law & Contemp. Probs. 47 (Summer 2006);
30. Scott M. Lassman, Transparency and Innuendo: An Alternative to Reactive Over-Disclosure, 69 Law & Contemp. Probs. 69 (Summer 2006);
31. Peter Lurie & Allison Zieve, Sometimes the Silence Can Be Like the Thunder: Access to Pharmaceutical Data at FDA, 69 Law & Contemp. Probs. 85 (Summer 2006).
32. Haack was included in Peter J. King, 100 Philosophers: The Life and Work of the World's Greatest Thinkers 180 (2004). She is the Cooper Senior Scholar in Arts and Science and Professor of Philosophy and Law at the University of Miami.
33. Haack, supra note 18, at 52-60.
34. Id.
35. Id. at 59.
36. Id. at 60.
37. See id. (noting that this pressure "damages the fragile social mechanisms that sustain the scientific ethos of honest investigation and encourage free exchange of ideas and information").
38. See id. at 47 (referencing the works of several commentators that discuss the potential problems of commercially sponsored scientific research).
39. 35 U.S.C. §§ 200-212 (1980). This legislation allows small businesses and universities to elect ownership of patents over inventions created with federal funding and to become directly involved in the process of commercialization; it has the "policy and objective" of "promot[ing] collaboration between commercial concerns and nonprofit organizations, including universities."
40. Id. at § 200.
41. Sheldon Krimsky, Science in the Private Interest: Has the Lure of Profits Corrupted the Virtue of Biomedical Research? (2003).
42. See Haack, supra note 18, at 60-61.
43. Frank Davidoff et al., Sponsorship, Authorship and Accountability, 286 JAMA 1232, 1233 (2001). The statement was jointly issued by the editors of thirteen leading journals.
44. Id.
45. See Complaint, State v. GlaxoSmithKline (N.Y. Sup. Ct. June 2, 2004), available at http://files.findlaw.com/news.findlaw.com/cnn/docs/glaxo/ nyagglaxo60204cmp.pdf.
46. See, e.g., Eliot Marshall, Buried Data Can Be Hazardous to a Company's Health, 304 Science 1576, 1576-77 (2004);
47. Editorial, Is GSK guilty of fraud?, 363 Lancet 1919, 1919 (2004).
48. See Press Release, Office of New York State Attorney General Eliot Spitzer, Statement Regarding Decision by GlaxoSmithKline to Post Summaries of Clinical Trial Result (June 18, 2004) (on file with author). Spitzer stated that it was "unacceptable for companies like GSK to divulge favorable results while hiding negative data when the health of patients is at stake." Id.
49. Press Release, Office of New York State Attorney General Eliot Spitzer, Forest Labs to Establish Clinical Trials Registry (Sept. 7, 2004)(on file with author).
50. See An-Wen Chan et al., Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles. 291 JAMA 2457, 2457-65 (2004) ("The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols."). This research arose out of the uproar around incomplete reporting of clinical trial results, which led investigators to study the conduct and reporting of research itself. One of the challenges in conducting this research was to identify either a representative or complete sample of clinical trials that have been initiated in order to see when and how the results were provided to the public. An ingenious group of European researchers was able to take this on, utilizing the records of the Scientific-Ethical Committees for Copenhagen and Frederiksberg, Denmark, the Institutional Review Board (IRB) through which all clinical trials conducted in that region must be registered and approved. There were 102 trials approved in 1994-1995 that eventually were completed and published, resulting in 122 journal articles. The researchers found that half the efficacy outcomes and sixty-five percent of harm outcomes were incompletely reported. More than sixty percent of the trials had at least one primary outcome that was changed, introduced after the protocol was approved, or omitted. Eighty-six percent of survey responders (forty-two out of forty-nine) denied the existence of unreported outcomes despite clear evidence to the contrary.
51. Id. at 2457.
52. See, e.g., Marcia Angell, The Truth About Drug Companies (2004);
53. Jerome P. Kassirer, On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health (2005);
54. Richard Smith, Medical Journals are an Extension of the Marketing Arm of Pharmaceutical Companies, 2 Pub. Libr. Sci. Med. 364, 364-66 (2005).
55. See C. DeAngelis et al., Is this Clinical Trial Fully Registered? A Statement from the International Committee of Medical Journal Editors, 352 N. Eng. J. Med. 2436, 2436-38 (2005) "In September 2004, the members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials." The members of the ICMJE will consider a trial for publication only if it is registered for the purpose of providing a "comprehensive, publicly available database of clinical trials."
56. See C. Rowland, Drug Firms Lagging on Openness, Boston Globe, Jan. 9, 2005, at A1. Despite increased levels of voluntary disclosure by drug firms, "[a] Globe review of websites indicates that the voluntary approach has produced limited disclosures thus far."
57. Id.
58. Press Release, Food and Drug Administration, New Drug Safety Initiative (May 5, 2005), available at http://www.fda.gov/cder/drugSafety.htm.
59. Draft Guidance for the Industry on the Food and Drug Administration's "Drug Watch" for Emerging Drug Safety Information; Availability, 70 Fed. Reg. 24,606 (May 10, 2005).
60. Lassman, supra note 18, at 69. Lassman is Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA).
61. Id.
62. Id.
63. See also Scott Lassman & Alan Goldhammer, RE: Docket No. 2005D-0062, FDA Request for Comments on the Draft Guidance entitled, "FDA's 'Drug Watch' for Emerging Drug Safety Information," 70 Fed. Reg. 24,606 (May 10, 2005), (PhrMA), Aug. 8, 2005, available at http://www.fda.gov/ohrms/ dockets/dockets/05d0062/05d-0062-c000013-vol1. pdf.
64. See John S. Applegate, The Perils of Unreasonable Risk: Information, Regulatory Policy, and Toxic Substances Control, 91 Colum. L. Rev. 261 (1991);
65. Mary Lyndon, Information Economics and Chemical Toxicity: Designing Laws to Produce and Use Data, 87 Mich. L. Rev. 1795 (1989);
66. David Roe, Barking up the Right Tree: Recent Progress in Focusing the Toxics Issue, 13 Colum. J. Envtl. L. 275 (1988).
67. Id.
68. Id.
69. Lassman, supra note 18, at 76-78.
70. See Gardiner Harris, F.D.A. Official Admits 'Lapses' on Vioxx, N.Y. Times, Mar. 2, 2005, at A15 (quoting an FDA official that the agency "[doesn't] have the authority to tell a company, 'this is how your label has to look'.... We have to negotiate with the company the specific language of how things should be worked, the placement, those kinds of things, after talking to them."). This statement came in testimony at a 2004 U.S. Senate hearing investigating FDA's approval of Vioxx (rofecoxib), a situation that illustrates the public health consequences of FDA's inability to specify the content of warning labels. It took more than a year for information about the cardiovascular risks of Vioxx identified by an FDA advisory panel to be added to the drug's label. According to at least one account, FDA and Merck "battled over the label."
71. Anna Wilde Mathews, Did FDA Staff Minimize Vioxx's Red Flags?, Wall St. J., Nov. 10, 2004, at B1.
72. See also Anna Wilde Mathews & Barbara Martinez, E-mails Suggest Merck Knew Vioxx's Dangers at Early Stage, Wall St. J., Nov. 1, 2004, at A1.
73. Notwithstanding Lassman's conclusions, the recent history of the marketing and withdrawal of Vioxx (rofecoidb), discussed infra in Part III, is an illustration of the problems associated with that type of reliance on the interpretation of data by scientists with financial conflicts of interest.
74. For more information about Public Citizen's Health Research Group, see http://www.citizen.org/hrg.
75. Id.
76. Sidney Wolfe, Is the FDA Adequately Assuring Drug Safety?, Power Point Presentation at the Food and Drug Law Institute (FDLI) 48th Annual Conference, Preparing for the Next Century of Drug Regulation, April 7, 2005.
77. Of the drugs implicated in the twenty-seven petitions, eighteen (sixty-seven percent) were eventually withdrawn from the market, and the use of an additional four (fifteen percent) has been severely limited. Id.
78. Lurie & Zieve, supra note 18, at 87-95. Lurie is a physician and Deputy Director of HRG; Zieve is Senior Attorney of HRG.
79. U.S.C. § 552 (2000). FOIA requires that, upon request by any person, an agency must disclose documents that do not fall into one of nine specific exemptions from disclosure. Id.
80. U.S.C. App. II § § 1-15 (2000).
81. Federal advisory committees constituted under FACA are subject to disclosure requirements, including an advance notice of upcoming meetings and opportunities for public attendance and input. Id. at § 10.
82. Kenneth I. Kaitin, et al., FDA Advisory Committees and the New Drug Approval Process, 29 J. Clinical Pharmacology 886 (1989).
83. Lurie & Zieve, supra note 18, at 90.
84. Id. at 93.
85. Sidney A. Shapiro & Rena I. Steinzor, The People's Agent: Executive Branch Secrecy and Accountability in an Age of Terrorism, 69 Law & Contemp. Probs. 99, (Summer 2006). Shapiro is Distinguished Chair in Law at Wake Forest University, and Steinzor is Professor of Law at University of Maryland School of Law. Both authors are among the founders of the Center for Progressive Reform, a nonprofit research and educational organization that focuses on the government's role in protecting health, safety, and the environment.
86. Id. at 97.
87. Id. at 99.
88. See id. at 126. ("Presumably acting under [Rumsfeld's and Cheney's] advice, President Ford vetoed amendments expanding the FOIA, only to have his veto overridden by Congress.").
89. U.S.C. § 131 (2002).
90. Shapiro & Steinzor, supra note 61, at 99.
91. Id.
92. Daniel J. Givelbeŕ & Anthony Robbins, Public Health vs. Court-sponsored Secrecy, 69 Law & Contempt. Probs. 131 (Summer 2006).
93. Id. at 131.
94. Id. at 129.
95. See Arthur R. Miller, Confidentiality, Protective Orders, and Public Access to the Courts, 105 Harv. L. Rev. 427, 490-501 (1991).
96. One important rationale often made for confidentiality agreements is efficiency; there is debate over a feared "chilling" impact of forced transparency on the willingness of parties to settle cases before trial. Some years ago, Arthur R. Miller wrote that restrictions on the use of mechanisms that sequester information uncovered in the course of litigation would discourage settlements and result in further burdening the court system. Id.
97. These restrictions are unnecessary, because judges currently have the discretion to ensure that information important to public welfare is provided to appropriate government agencies. Id.
98. In response, James E. Rooks Jr. has recently pointed out that there is no empirical evidence of an increase in trial rates in jurisdictions imposing limits on secrecy in litigation. James E. Rooks Jr., Settlements and Secrets: Is the Sunshine Chilly?, 55 S.C. L. Rev. 859, 870-75 (2004).
99. See Jack B. Weinstein, Symposium: Panel II: Secrecy and the Civil Justice System, Secrecy in Civil Trials: Some Tentative Views, 9 J. Law & Pol'y 53, 65 (2000) (maintaining that while "each case is different," generally, "where there is doubt, secrecy [orders in litigation] should be rejected").
100. See Joseph S. Anderson, Hidden from the Public by Order of the Court: The Case Against Government-Enforced Secrecy, 55 S.C. L. Rev. 711, 716-50 (2004) (discussing the actions taken in such cases by the judges of the U.S. District Court for the District of South Carolina).
101. Jack B. Weinstein & Catherine Wimberly, Secrecy in Law and Science, 23 Cardozo L. Rev. 1, 11 (2001). Judge Jack Weinstein is Senior Judge of the U.S. District Court for the Eastern District of New York and has presided over mass torts cases involving, among other toxins, asbestos, and agent orange.
102. Givelber & Robbins, supra note 67, at 136.
103. James W. Conrad, Jr., Open Secrets: The Widespread Availability of Information about the Health & Environmental Effects of Chemicals, 69 Law & Contemp. Probs. 141 (Summer 2006). Conrad is Assistant General Counsel of the American Chemistry Council, the trade association of U.S. chemical manufacturing companies.
104. U.S.C. § § 2601-2692 (2000).
105. U.S.C. § § 136-136y (2000).
106. Pub. L. No. 107-204, 116 Stat. 745 (2002) (codified as amended in scattered sections of 15 U.S.C.).
107. Conrad, supra note 75, at 163.
108. Id. at 140-55.
109. U.S. Gen. Accounting Office, Rep. 05-458, Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage its Chemical Review Program 5 (2005). TSCA generally prohibits disclosing to nonfederal officials trade secrets and privileged or confidential information protected under the Freedom of Information Act. In addition, TSCA authorizes chemical companies to claim data as confidential business information. According to EPA officials, about 95 percent of the premanufacture notices for new chemicals submitted by chemical companies contain some information that is claimed as confidential.... While TSCA confidential business information can be provided to federal officials and contractors, it generally cannot be provided to other organizations responsible for assessing chemical risks, enforcing chemical control laws, and performing other environmental activities, including state regulatory agencies and foreign governments.
110. See id. ("While EPA has the authority to evaluate the appropriateness of confidentiality claims and can deny companies' claims of confidentiality if they are found to be illegitimate, these efforts are time[-] and resource-intensive, and the agency does not have the resources to challenge a significant[ly] large number of claims."). See ("While EPA has the authority to evaluate the appropriateness of confidentiality claims and can deny companies' claims of confidentiality if they are found to be illegitimate, these efforts are time[-] and resource-intensive, and the agency does not have the resources to challenge a significant[ly] large number of claims.")
111. See Wendy Wagner & David Michaels, Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research, 30 Am. J.L. & Med. 119, 130 (2004) ("Under most existing regulations, the CBI claims require no substantiation - a manufacturer has only to stamp the documents "confidential" for the privilege to apply."). In fact, no official from the company need take responsibility for asserting the claim; there are no penalties for asserting the claim when it is facially frivolous; and the firm is presumed to waive the privilege, or at least must justify it later, if they do not stamp this information as confidential when first submitting it to the agency. Once the information is publicly disseminated, the company loses its right to claim misappropriation of a trade secret. Based on this regulatory structure, firms openly concede that it is more cost-effective for them to routinely stamp much internal information as CBI when no substantiation is required.
112. Studies show that firms take full advantage of this generous approach to trade secrets and make the claim for information even when doing so is clearly without merit. In 1990, for example, EPA reviewed CBI claims under the Toxic Substances Control Act and challenged some nonmeritorious claims. By 1992, "industry had voluntarily amended and withdrawn over 600 claims after EPA's inquiries." CBI claims drop substantially (by as much as 50-60%) when EPA does require upfront substantiation of the nature of the trade secret protections, which it is legislatively required to do in other programs. Id. at 130-34. Studies show that firms take full advantage of this generous approach to trade secrets and make the claim for information even when doing so is clearly without merit. In 1990, for example, EPA reviewed CBI claims under the Toxic Substances Control Act and challenged some nonmeritorious claims. By 1992, "industry had voluntarily amended and withdrawn over 600 claims after EPA's inquiries." CBI claims drop substantially (by as much as 50-60%) when EPA does require upfront substantiation of the nature of the trade secret protections, which it is legislatively required to do in other programs
113. Conrad, supra note 75, at 160-62.
114. Id.
115. Sheldon Krimsky, Science in the Private Interest: Has the Lure of Profits Corrupted the Virtue of Biomedical Research? (2003).
116. J.E. Bekelman et al., Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review, 289 JAMA. 454, 454-65 (2003);
117. Sheldon Krimsky, The Funding Effect in Science and its Implications for the Judiciary, 13 J. Law & Pol'y 43 (2005);
118. Joel Lexchin et al., Pharmaceutical Industry Sponsorship and Research Outcome and Quality, 326 Brit. Med. J. 1167 (2003);
119. Richard Smith, Medical Journals are an Extension of the Marketing Arm of Pharmaceutical Companies, 2 Pub. Libr. Sci. Med. 364, 364-66 (2005).
120. See F.S. Vom Saal & C. Hughes, An Extensive New Literature Concerning Low-dose Effects of Bisphenol A Shows the Need for a New Risk Assessment, 113 Envtl. Health Persp. 926 (2005) (discussing a possible funding effect in research on low-dose exposure to bisphenol A (BPA), an environmental estrogen used in the manufacture of polycarbonate plastic, a resin widely used in food cans and dental sealants). As recounted by the authors, exposure to BPA had been found in some studies to alter endocrine function at very low doses. In response, the American Plastics Council hired the Harvard Center for Risk Analysis (HCRA) to conduct a "weight of the evidence" review of the toxicology; the HCRA panel reviewed nineteen animal studies and reported that it found no consistent affirmative evidence of low-dose BPA effects.
121. Id. This conclusion was challenged by government-funded scientists who felt that HCRA had chosen to examine only a minority of the forty-seven studies available at the time. These scientists reviewed the 115 published studies available in December 2004 and found results that differed markedly from the HCRA analysis. They determined that ninety percent (94 of 104) of the studies paid for with government funds reported an effect associated with BPA exposure; however, not a single one of the eleven corporate-funded studies found an effect. This conclusion was challenged by government-funded scientists who felt that HCRA had chosen to examine only a minority of the forty-seven studies available at the time. These scientists reviewed the 115 published studies available in December 2004 and found results that differed markedly from the HCRA analysis. They determined that ninety percent (94 of 104) of the studies paid for with government funds reported an effect associated with BPA exposure; however, not a single one of the eleven corporate-funded studies found an effect
122. Allen L. White, Why We Need Global Standards for Corporate Disclosure, 69 Law & Contemp. Probs. 167 (Summer 2006). White is Vice President of the Tellus Institute and co-founder of the Global Reporting Initiative.
123. Id. at 167.
124. Id. at 175.
125. Id.
126. Id.
127. See Lisa M. Fairfax, Form Over Substance?: Officer Certification and Promise of Enhanced Personal Accountability under the Sarbanes-Oxley Act, 55 Rutgers L. Rev. 1, 12 (2002) (citing how several executives of Enron and WorldCom claimed to be unaware of their respective company's wrongdoing).
128. Id. at 1-4.
129. Pub. L. No. 107-204, 116 Stat. 745 (2002) (codified as amended in scattered sections of 15 U.S.C.).
130. See also Robert G. Vaughn, America's First Comprehensive Statute Protecting Corporate Whistleblowers, 57 Admin. L. Rev. 1 (2005).
131. Claire Bombardier et al., Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis, 343 N. Eng. J. Med. 1520, 1520 (2000).
132. See, e.g., Marvin A. Konstam et al., Cardiovascular Thrombotic Events in Controlled, Clinical Trials of Rofecoxib, 104 Circulation 2280, 2280-88 (2001);
133. Marvin A. Konstam & Laura A. Demopoulos, Letter to the Editor, Cardiovascular Events and COX-2 Inhibitors, 286 JAMA 2809 (2001).
134. Merck conducted a trial to determine if Vioxx inhibited the development of colon polyps; since there are no other treatments that accomplish this, the study compared Vioxx with a placebo.
135. Press Release, Food and Drug Administration, FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product (Sept. 30, 2004) available at http://www.fda.gov/bbs/topics/news/2004/ NEW01122.html;
136. see also Robert S. Bresalier, Robert S. Sandler, Hui Quan, et. al., Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial, 352 N. Eng. J. Med. 1092 (2005).
137. FDA, Merk and Vioxx: Putting Patient Safety First?: Hearing before the S. Comm. on Finance, 108th Cong. 1 (2004) (statement of David J. Graham, MD, MPH).
138. See Wendy Wagner & David Michaels, Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research, 30 Am. J.L. & Med. 119 (2004).
139. Jasanoff, supra note 12, at 22.