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GOVERNMENT, POLITICS, AND LAW |
At the time of writing, Annamaria Baba was with the Department of Clinical Pharmacy at the University of California, San Francisco. Daniel M. Cook is with the Center for Tobacco Control Research and Education at the University of California, San Francisco. Thomas O. McGarity is at the University of Texas School of Law, Austin. Lisa A. Bero is at the Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California, San Francisco.
Correspondence: Request for reprints should be sent to Lisa A. Bero, PhD, Department of Clinical Pharmacy and Health Policy, University of California, San Francisco, 3333 California Street, Suite 420, Box 0613, San Francisco, CA 94143 (e-mail: bero{at}medicine.ucsf.edu).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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In the late 1990s, in an effort to dispute the link between secondhand smoke and lung cancer, Philip Morris initiated a campaign to legislate "sound science." The campaign involved enacting data access and data quality laws to obtain previously confidential research data in order to reanalyze it based on industry-generated data quality standards. Philip Morris worked with other corporate interests to form coalitions and workgroups, develop a "data integrity" outreach program, sponsor symposia on "research integrity," and draft language for the new acts.
The tobacco industry played a role in establishing laws that increase corporate influence on public health and regulatory policy decisions.
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INTRODUCTION |
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).2
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).4 Although the public had an opportunity to comment on implementing the regulations, these amendments were initially passed and adopted without a legislative hearing, committee review, or debate.5 The scientific, academic research, and public health communities voiced concerns during the public comment period about potential problems with confidentiality of medical information, discouragement of research subjects, misinterpretation of incomplete or prematurely released data sets, delay of research, protection of national security information, and administrative and financial burdens.6 The research community was also concerned that these measures were supported by industry groups seeking to contest environmental and other regulations.2 Together, the data access and data quality acts provide a mechanism for challenging the scientific merit of data outside of scientific journals and other channels of scientific review.7,8 Internal tobacco industry documents that have been made available through litigation give us the opportunity to analyze one industry’s involvement in a broader industry strategy to secure enactment of the data access and data quality provisions. These documents provide unprecedented insight into the industry’s motives, strategies, and tactics9 to challenge the scientific basis for public health policies.10–12 In the 1990s Philip Morris implemented a 10-year "sound science" public relations campaign to create controversy regarding evidence that environmental toxins cause disease.13 Our article describes the tobacco industry’s later campaign to advance the "sound science" concept via legislation.
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METHODS |
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Initial searches yielded hundreds of documents including letters, memorandums, and reports. The documents were read, and all of those relevant to the data access and data quality acts were selected, yielding 100 documents. We assembled the documents chronologically, and the extent of tobacco industry association with "sound science" legislation emerged. For reliability of interpretation, the documents were read and analyzed separately by all four authors. The grouping of the documents in this report was discussed by all of the authors.
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RESULTS |
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Asking researchers: "the scientific cultural method" of obtaining data. In its quest to discredit the Environmental Protection Agency risk assessment of secondhand smoke, Philip Morris made repeated requests to Dr Elizabeth Fontham for her research data.14,15 Fontham published studies in 1991 and 1994 demonstrating that exposure to secondhand smoke during adult life increases risk of lung cancer in lifetime nonsmokers.16,17
In collaboration with Philip Morris, consultant Jim Tozzi wrote letters to Elizabeth Fontham asking her to release her data.14,18 According to Tozzi, "a complete reevaluation of the published Fontham data by [his firm] Multinational Business Services leads to the strong conclusion that the Fontham results are more likely to be the result of various analytical and statistical errors and bias rather than demonstrating a significant positive correlation. For this reason, we remain convinced of the importance of releasing the underlying Fontham data so that such data may be subject to objective scientific analysis."19
Dr Fontham refused to comply with these requests, explaining that "the investigators of her study are concerned that these data be used solely for furthering science and that they not be distorted by the economic interests of other parties who analyze them."20 Philip Morris referred to the initial contact letter with Dr Fontham as the "first of a series of very graduated steps to obtain the so-called Fontham data by the scientific cultural method."21 In other words, they hoped to rely on the norm among scientists of requesting data from each other.
The litigation strategy. Philip Morris then initiated discovery requests in ongoing lawsuits to gain access to the Fontham data through litigation.22.23 In May 1995, Philip Morris executives commented that "based on previous experiences in attempting to obtain raw data from federally funded epidemiology studies, this will be a very difficult task."24 In a memo to Philip Morris executives, Tozzi expressed concerns that "the judicial fate of the Fontham data is questionable" and that a member of Congress "should ask the Secretary of Health and Human Services to release the data underlying Fontham."25 The litigation strategy met with limited success, as the courts often denied the requests, only limited pieces of the data were released, and papers based on the re-analysis of such data proved difficult to publish.26,27
The legislative strategy: data access and data quality.
Table 2 lists the key events in Philip Morris’ role in the data access and quality acts. A Philip Morris strategy meeting held on March 15, 1996, assigned to Richard Carchman, Director of Scientific Affairs for Philip Morris Incorporated, the task of "prepar[ing] model data disclosure language for the instances of contested interpretation of underlying data in published studies."28 The notes from a May 1996 meeting show that Philip Morris executives discussed how "the acquisition of data is a major goal" for the company, developed a position statement on data sharing, and identified company executives to take the lead on a policy strategy for data disclosure.29
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The document additionally explains that in order for this strategy to succeed, the tobacco industry needs to take the necessary precautions to remain in the background of the public debate and ultimately develop epidemiological criteria to evaluate the quality of research data.30 Thus, this 1997 planning document also lays the groundwork for the data quality act.
As shown in Table 3, the Philip Morris planning document also shows "best and worst case scenarios" for the industry in the event that the data access and data quality acts pass. A 1997 Philip Morris document entitled "sound science project" also lists the industry’s dual objective as the following: (1) to gain passage of federal law on criteria/standards for epidemiological studies; and (2) to legislate public access to epidemiological data used in support of federal laws and regulations.31 The document explained that "our plans must always include developing the right criteria that will favorably evaluate and be applicable to ETS."30
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Implementing the Legislative Strategy–Data Access
The Philip Morris draft "sound science project" identifies team leaders who are assigned specific roles for carrying out the project’s objectives. Table 4 lists potential strategies for legislating data access and data quality provisions.31,33 Although Philip Morris planned for an active role, its documents emphasize that this role should remain hidden from the public.30
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In November 1997, Philip Morris executives held meetings with the Center for Regulatory Effectiveness (CRE) to discuss draft language for the data access act. CRE is an advocacy group established in 1996 that monitors the federal regulatory process. CRE prepared a document exploring the link between data integrity and data sharing, identifying legislative precedents on which to build the new policy and outlining criteria for assuring high quality data.35
By March of 1998, a document in Philip Morris files marked "confidential" listed a summary of data disclosure messages that could be used to support data access laws.36 The document identified potential supporters and opponents of data disclosure in the food, health, pharmaceutical, chemical, energy, transportation, insurance, and waste products industries.
The data access act was passed in September 1998 and implemented a year later, on October 8, 1999. During this year, Philip Morris hired Jim Tozzi to coordinate industry efforts to ensure that OMB implemented the new law consistently with industry interests.37 A contract dated December 24, 1998, shows that Philip Morris Worldwide Regulatory Affairs hired Tozzi to "work with federal agencies to encourage implementation of the recently enacted data access and data quality provisions." Philip Morris planned to compensate Jim Tozzi with a monthly retainer of $65,000.38,39 Shortly after Congress enacted the data access act, Tozzi met with OMB to develop a strategy for implementing both data access and data quality provisions.40,41 In December 1998, 3 months after the data access act became law, he submitted a workplan on data access and data quality to Matt Winokur of Philip Morris. Winokur was director of Philip Morris Worldwide Regulatory Affairs and a member of the five-person "sound science issues team."42 The workplan included plans to do the following: (1) solicit views of federal agency officials and draft prototype regulations on data access and quality; (2) present and market draft regulations for data access and data quality to various federal agencies; (3) keep congressional committees (appropriations, science, commerce, etc.) updated on data access and data quality developments; (4) brief congressional committee members and staff on the proposed regulations and elicit support; (5) identify supportive states, brief these states on developments involving the law, and elicit support for the proposed regulations before OMB and the federal agencies; and (6) advance the proposed regulations by building a coalition on data access and data quality issues with the Center for Regulatory Effectiveness, trade associations, and interested stakeholder groups.43,44
The CRE, with Jim Tozzi as the lead advisory board member, made plans to create a workgroup to address data access and data quality. In a memo to Matt Winokur, Tozzi commented that his firm had made recommendations for data access and data quality to OMB. His firm would be meeting with "approximately a dozen major industrial firms and trade associations to discuss the possibility of forming a work group under the auspices of the CRE to address this issue."45
Tozzi invited the Chemical Manufacturers Association to a meeting to discuss member participation in specific work groups targeting issues of interest to the industry.46 The work group’s goal was to "ensure that OMB meets its September 30, 1999 deadline for issuing guidance that will require agencies to: (a) provide the regulated community with access to ‘underlying’ or ‘raw’ data; and (b) ensure the accuracy of information used by agencies in decision-making."46 The memo explained that the work group would also "ensure that: (a) substantive provisions of importance to the Work Group are included in the final guidance document; and (b) key rulemaking agencies, such as EPA and FDA, issue agency-specific guidance implementing the OMB guidance."46
Another Tozzi-affiliated advocacy group, Federal Focus, Inc, worked with Philip Morris to implement the data access and data quality amendments. Federal Focus, Inc,47 has a prior history of working on the Philip Morris "sound science" campaign.13 In an internal tobacco industry document, Federal Focus, Inc, discussed "current and planned activities which Federal Focus would undertake to advance and build popular support for data access/data integrity measures."48 Federal Focus drafted strategies for influencing data access and data quality guidelines 48 and planned to involve other business groups including the automotive, telecommunications, pulp and paper, financial, and food and beverage industries in this effort.48
Federal Focus sponsored seminars, including a joint symposium with the American Association for the Advancement of Science to encourage discussion of the data initiatives. A memo from Jim Tozzi to Matthew Winokur at Philip Morris states that "cooperation with AAAS [American Association for the Advancement of Science], as represented by the symposium will offer considerable credibility to our overall effort."49,50 The symposium was held on February 26, 1999, with the briefings prepared by Federal Focus.51
Implementing the Legislative Strategy–Data Quality
Three months after the data access act was implemented, Jim Tozzi focused his efforts on getting OMB to promulgate data quality guidelines. In a letter dated January 17, 2000, Tozzi informed OMB official John Spotila that CRE had drafted a model Notice of Proposed Rule-making on Data Quality (NPRM). Tozzi claimed that "Congress had already instructed OMB to promulgate a data quality regulation by the end of [the 1999] fiscal year."52 According to Tozzi, since OMB had not yet complied with this mandate, CRE took the initiative in developing model data quality guidelines for OMB to follow.
Tozzi explained that CRE would publish the model data quality document on the internet as an "interactive public docket" where the public could submit comments regarding the new guidelines. CRE would then prepare a summary of the comments, make revisions to the model guidelines based on the comments, and transmit the finalized draft to OMB.52
Shortly after sending this letter to OMB, Tozzi contacted Robert Elves of Philip Morris to tell him that CRE could "use an experienced hand as it proceeds down the data quality road" and that he looked "forward to Philip Morris’s continued involvement in this endeavor."53 In a later letter to Elves, Tozzi outlined a schedule of events on data quality for Philip Morris to review. This included plans for discussions with industry stakeholder groups on the draft OMB regulation for data quality, discussions on draft regulation with federal agencies and the administration, and presentation of the draft OMB regulation to the administration.54 Furthermore, the outline specified that if OMB did not adopt the data quality regulations by July 1, 2001, CRE would initiate judicial action.54
A series of memos between Philip Morris and CRE indicate that Philip Morris contributed to the content and language of the model data quality guidelines that Jim Tozzi sent to OMB.55–59 Philip Morris executives reached consensus on the language of the data quality act on April 14, 2000, and sent their final comments to CRE on June 26, 2000.56,60
Congress enacted the data quality act shortly thereafter as a two-paragraph provision buried in the Fiscal Year 2001 Treasury and General Government Appropriation Act. It is similar to the model draft created by CRE and stipulates that OMB must develop guidelines to "provide policy and procedural guidance to federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information disseminated by federal agencies" (Table 1). The data quality act directs federal agencies to issue their own conforming data quality guidelines using OMB guidelines as a model.4 "Influential data" as defined in Table 1 must be reproducible upon reanalysis.4 This requirement only applies to federally funded and not privately sponsored research. The scientific community has typically relied on peer review, not government standards, to ensure data quality.
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DISCUSSION |
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However, as scientists, legal experts, and environmentalists have pointed out, the data access and data quality riders have the potential to block agencies from using emerging science and slow the regulatory process.62–64 The laws could shift the scientific standards of data used for policy purposes. Although the tobacco industry intended to hide its involvement in the data access and quality acts, our analysis of the internal industry documents reveals that these policies were driven by corporate interests.
Opponents of the data access and data quality acts predicted that industry groups would use the new procedures to delay dissemination of or retract information that can be used to regulate their industry. Corporate interests have initiated the vast majority of data quality act challenges. Corporate advocacy groups including the CRE, the Competitive Enterprise Institute, the US Chamber of Commerce, the Salt Institute, and others have filed petitions challenging the data upon which health-related regulations are based.65–69
More recently, OMB proposed new guidelines for peer review standards to be used by federal agencies as "part of an ongoing effort to improve the quality, objectivity, utility, and integrity of information disseminated by the federal government to the public."70 CRE submitted comments to OMB in support of the revisions and explained that the proposed changes in peer review are necessary in order for OMB to meet its legal responsibilities under the data quality act.71 Scientists, public health professionals, and health organizations have expressed concerns about the new requirements. They point out that the language politicizes science by giving the White House unregulated power to expedite or delay the release of scientific information.64
Our analysis of the tobacco industry’s role in the data access and quality acts provides a window into the collaboration among corporate interests. The petitions challenging national public health studies and environmental risk assessments that followed demonstrate the potentially broad application of these policies. All of these challenges, if successful, would lead to weaker public health protections and less corporate oversight. The peer review revisions recently proposed are an indication of continued corporate involvement in public health research policies.
To combat corporate obstruction of public health policies, scientists can actively support regulatory agencies that are the targets of abusive data quality act challenges by filing critiques of such challenges with the relevant agencies. Agencies are required to consider such critiques. Finally, the scientific community should support efforts by public interest groups to induce companies to make privately sponsored health and safety testing data available to scientists for interpretation and analysis. The decision by several drug companies to register all company-sponsored studies on the Internet should be expanded to include the raw data underlying those studies.72 The scope of these efforts should be expanded to include all company data relevant to the health and safety of toxic chemicals that are released into workplaces and the environment.
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Acknowledgments |
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We thank the University of California San Francisco Institute for Health Policy Studies writing seminar participants for valuable comments on this paper.
Human Participant Protection
This study analyzes publicly available documents and was exempt from institutional review board approval.
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Footnotes |
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Contributors
L. A. Bero conceived and designed the study, advised on the search, read and analyzed documents, and edited the article. A. Baba conducted the document search, read and analyzed the documents, and drafted the article. D. M. Cook and T. O. McGarity read and analyzed documents, and edited the paper.
Accepted for publication November 16, 2004.
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References |
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2. Zacaroli A. BNA Daily Environment Report. Budget Provision in Spending Law Opens Access to Data Underlying Federally Funded Studies. 30 Oct 1998. Philip Morris. Bates No. 2065231101/1103. http://legacy.library.ucsf.edu/tid/lbn83c00. Accessed June 28, 2004.
3. Executive Office of the President, Office of Management and Budget, OMB Circular a-110. "Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other NonProfit Organizations." In: 64 Fed. Reg. 54926; 1999.
4. OMB Watch. Background on Data Quality Guidelines. May 28, 2002. http://www.ombwatch.org/article/articleprint/773/-1/1. Accessed May 3, 2004.
5. Renner R. Little Law Could Block Major Government Decisions. Nov. 7, 2002. http://www.pubs.acs.org/subscribe/journals/esthag-w/2002/nov/policy/rr_epaguidelines.html. Accessed May 2, 2004.
6. American Association for the Advancement of Science. Strong Response for Proposed Circular Change. June 1999. http://www.aaas.org/spp/cstc/pne/pubs/stc/bulletin/articles/6-99/OMBA-110. Accessed May 2, 2004.
7. McGarity TO. Our science is sound science and their science is junk science: science-based strategies for avoiding accountability and responsibility for risk-producing products and activities. The University of Kansas Law Review 2004;52(4):897–937.
8. Kaiser J. Researchers and lawmakers clash over access to data. Science. 1997;277(5325):467.
9. Bero L. Implications of the tobacco industry documents for public health and policy. Annu Rev Public Health. 2003;24:267–288.[CrossRef][ISI][Medline]
10. Montini T, Mangurian C, Bero LA. Assessing the evidence submitted in the development of a workplace smoking regulation: the case of Maryland. Public Health Rep. 2002;117(3):291–298.[CrossRef][ISI][Medline]
11. Schotland MS, Bero LA. Evaluating public commentary and scientific evidence submitted in the development of a risk assessment. Risk Anal. 2002; 22(1):131–140.[CrossRef][ISI][Medline]
12. Bero LA, Montini T, Bryan-Jones K, Mangurian C. Science in regulatory policy making: case studies in the development of workplace smoking restrictions. Tob Control. 2001;10(4):329–336.
13. Ong EK, Glantz SA. Constructing "sound science" and "good epidemiology": tobacco, lawyers, and public relations firms. Am J Public Health. 2001; 91(11):1749–1757.
14. Carchman R. Philip Morris. Letter to Fontham. 12 Nov 1996. Philip Morris. Bates No. 2060567119/7123. http://legacy.library.ucsf.edu/tid/sxc13e00. Accessed May 4, 2004.
15. Philip Morris. Letter. 1996. Philip Morris. Bates No. 2063778548/8551. http://legacy.library.ucsf.edu/tid/vdi05c00. Accessed June 28, 2004.
16. Fontham ET, Correa P, WuWilliams A, et al. Lung cancer in nonsmoking women: a multicenter case-control study. Cancer Epidemiol Biomarkers Prev. 1991;1(1):35–43.[Abstract]
17. Fontham ET, Correa P, Reynolds P, et al. Environmental tobacco smoke and lung cancer in nonsmoking women. a multicenter study. JAMA. 1994; 271(22):1752–1759.[Abstract]
18. Tozzi J. 10 Sep 1996. Philip Morris. Bates No. 2063640314/0315. http://legacy.library.ucsf.edu/tid/kdi67e00. Accessed May 4, 2004.
19. Tozzi J. Multinational Business Services. Analysis of Fontham Data. 10 Sep 1996. Philip Morris. Bates No. 2063640313. http://legacy.library.ucsf.edu/tid/jdi67e00. Accessed May 4, 2004.
20. Alterman T, Austin DF, Boyd P, et al. LA State University Medical Center. 11 Mar 1997. Philip Morris. Bates No. 2063778589/8591. http://legacy.library.ucsf.edu/tid/bfi05c00. Accessed May 4, 2004.
21. Seeman J. 17 May 1996. Philip Morris. Bates No. 2061685659. http://legacy.library.ucsf.edu/tid/rio67d00. Accessed May 4, 2004.
22. Mulderig J. Philip Morris. Wolpin v. Philip Morris Incorporated and Discovery of Fontham Full Data Set. 17 Sep 1998. Philip Morris. Bates No. 2063611048. http://legacy.library.ucsf.edu/tid/gur52d00. Accessed June 28, 2004.
23. Byer R, Davidson B, Groh R, et al. US Magistrate, USC. Wolpin v. Philip Morris, Inc Civil Minutes General Proceedings: Defendant’s Motion to Compel Production of Documents in Response to Subpoena Duces Tecum. Case No. Cv 98 3027 Rap (Jgx) (S.D. Florida Case No. 96 1781 Civ King). 9 Sep 1998. Philip Morris. Bates No. 2063611049/1050. http://legacy.library.ucsf.edu/tid/rkl67e00. Accessed June 28, 2004.
24. Philip Morris. Summary of Analysis of Fontham Study Results. 10 May 1995. Philip Morris. Bates No. 2050761128/1129. http://legacy.library.ucsf.edu/tid/jrl79e00. Accessed May 4, 2004.
25. Tozzi J. Multinational Legal Services. 24 Jul 1995. Philip Morris. Bates No. 2073266990. http://legacy.library.ucsf.edu/tid/bbq42c00. Accessed May 4, 2004.
26. Enstrom J. Environmental Tobacco Smoke and Lung Cancer in Nonsmoking Women: A Reanalysis. 24 Apr 1996. RJ Reynolds. Bates No. 515638686/8686. http://legacy.library.ucsf.edu/tid/bpi30d00. Accessed May 4, 2004.
27. Bero L, Glantz SA, Hong M. The limits of competing interest disclosures. Tobacco Control. 2005;14:118–126
28. Philip Morris. N484. 15 Mar 1996. Philip Morris. Bates No. 2048256867. http://legacy.library.ucsf.edu/tid/xwg57d00. Accessed June 17, 2004.
29. Philip Morris. Report. 14 May 1996. Philip Morris. Bates No. 2064229275/9276. http://legacy.library.ucsf.edu/tid/byv93c00. Accessed June 29, 2004.
30. Philip Morris. Force Field Analysis. May 1997. Philip Morris. Bates No. 2081324814/4818. http://legacy.library.ucsf.edu/tid/adx65c00. Accessed June 4, 2004.
31. SRIC Innovation. Sound Science Project. May 1997. Philip Morris. Bates No. 2081324784/4788. http://legacy.library.ucsf.edu/tid/xcx65c00. Accessed June 4, 2004.
32. Borell, Morris P. Sound Science Legislation. 30 Oct 1998. Philip Morris. Bates No. 2065231097/1098. http://legacy.library.ucsf.edu/tid/dbn83c00. Accessed May 4, 2004.
33. Philip Morris. Legislative Strategy. 6 May 1997. Philip Morris. Bates No. 2081324782/4783. http://legacy.library.ucsf.edu/tid/wcx65c00. Accessed June 4, 2004.
34. Philip Morris. Questions for Data Disclosure. 6 Oct 1997. Philip Morris. Bates No. 2081324590/4592. http://legacy.library.ucsf.edu/tid/mbx65c00. Accessed May, 4 2004.
35. Memorandum. Draft Outline for Legislation on Integrity and Dissemination of Federal Information. 12 Nov 1997. Philip Morris. Bates No. 2065341525/1531. http://legacy.library.ucsf.edu/tid/iet63c00. Accessed May, 4 2004.
36. Memorandum. Data Disclosure Messages. 27 Mar 1998. Philip Morris. Bates No. 2081324583/4589. http://legacy.library.ucsf.edu/tid/lbx65c00. Accessed May, 4 2004.
37. Mooney C. Paralysis by analysis. Washington Monthly. May 2004.
38. Winokur M. WRA Contract Request Form. 24 Dec 1998. Philip Morris. Bates No. 2064779000/9001. http://legacy.library.ucsf.edu/tid/klo93c00. Accessed May 5, 2004.
39. Becker D, Tozzi J. MBS PM. Project Agreement. 1 Jan 1998. Philip Morris. Bates No. 2064779002/9003. http://legacy.library.ucsf.edu/tid/llo93c00. Accessed May 5, 2004.
40. Tozzi J. Multinational Business Services. Letter to M. Winokur. 21 Oct 1998. Philip Morris. Bates No. 2065231111. http://legacy.library.ucsf.edu/tid/pxu63c00. Accessed May 5, 2004.
41. Tozzi J. Multinational Business Services. OMB Meeting. 20 Nov 1998. Philip Morris. Bates No. 2065231059. http://legacy.library.ucsf.edu/tid/uqm83c00. Accessed May 5, 2004.
42. Philip Morris. Report. 1 Jan 1999. Philip Morris. Bates No. 2065346539/6540. http://legacy.library.ucsf.edu/tid/rku63c00. Accessed Jun 11, 2004.
43. Tozzi J. Multinational Business Services. Letter. 16 Dec 1998. Philip Morris. Bates No. 2065230945/0946. http://legacy.library.ucsf.edu/tid/fsm83c00. Accessed June 29, 2004.
44. Philip Morris. Resource Requirements Data Access Data Quality. Dec 1998. Philip Morris. Bates No. 2065230947/0953. http://legacy.library.ucsf.edu/tid/gsm83c00. Accessed May 5, 2004.
45. Tozzi J. Multinational Business Services. Letter. 2 Nov 1998. Philip Morris. Bates No. 2065231092. http://legacy.library.ucsf.edu/tid/vpm83c00. Accessed June 29, 2004.
46. Tozzi J. Center for Regulatory Effectiveness. CRE Meeting Tuesday, 981201 Goals for 990000. 6 Nov 1998. Philip Morris. Bates No. 2065231075/1077. http://legacy.library.ucsf.edu/tid/qbn83c00. Accessed May 5, 2004.
47. Federal Focus. Federal Focus, Inc Mission. 6/28/04 2004. Bates No. http://www.fedfocus.org/mission.html. Accessed May 5, 2004.
48. Federal Focus. Federal Focus Outreach Program on Data Integrity a Proposal. 14 Dec 1998. Philip Morris. Bates No. 2065230955/0975. http://legacy.library.ucsf.edu/tid/trm83c00. Accessed May 5, 2004.
49. Tozzi J. Multinational Business Services. Meeting with EPA Officials on Data Access Data Quality. 11 Jan 1999. Philip Morris. Bates No. 2065230935. http://legacy.library.ucsf.edu/tid/wsm83c00. Accessed May 5, 2004.
50. AAAS. AAAS Work Relating to OMB Public Access and Data. 1999. http://www.aaas.org/spp/sfrl/projects. Accessed May 4, 2004.
51. Federal Focus. Briefing on Data Access. 1999. http://www.fedfocus.org/events_writings/aaas/wrapup.html. Accessed June 28, 2004.
52. Tozzi J. Center for Regulatory Effectiveness. Letter. 17 Jan 2000. Philip Morris. Bates No. 2072826846/6848. http://legacy.library.ucsf.edu/tid/hzp95c00. Accessed May 5, 2004.
53. Tozzi J. Center for Regulatory Effectiveness. Letter. 24 Jan 2000. Philip Morris. Bates No. 2072826845. http://legacy.library.ucsf.edu/tid/gzp95c00. Accessed June 29, 2004.
54. Tozzi J. Center for Regulatory Effectiveness. Letter. 29 Feb 2000. Philip Morris. Bates No. 2072826830/6831. http://legacy.library.ucsf.edu/tid/zyp95c00. Accessed June 29, 2004.
55. Elves R. Fax: USA Data Quality Initiative. 24 Jan 2000. Philip Morris. Bates No. 2505168249. http://legacy.library.ucsf.edu/tid/pcd49c00. Accessed June 4, 2004.
56. Elves R. Review Approve CRE Data Quality Initiative. 17 Mar 2000. Philip Morris. Bates No. 2072826818. http://legacy.library.ucsf.edu/tid/uyp95c00. Accessed May 5, 2004.
57. Philip Morris. Re: Data Quality Initiative. 27 Jan 2000. Philip Morris. Bates No. 2505168207. http://legacy.library.ucsf.edu/tid/bnd49c00. Accessed June 4, 2004.
58. Elves R. Your Review: Comments on CRE Data Quality Initiative. 3 Mar 2000. Philip Morris. Bates No. 2505135934/5935. http://legacy.library.ucsf.edu/tid/lzz25c00. Accessed June 4, 2004.
59. Philip Morris. Comments On: Center for Regulatory Effectiveness (CRE) Proposed Draft OMB Data Quality Regulation: Standards for Agency Regulations Governing Data Quality, Excerpt: 2. Identification of Substantive Standards for Data Quality. 17 Apr 2000. Philip Morris. Bates No. 2078738344/8348. http://legacy.library.ucsf.edu/tid/aga82c00. Accessed May 5, 2004.
60. Walk R. Philip Morris. Comments by Philip Morris USA Worldwide Scientific Affairs on CRE Proposed Draft Quality Regulation. 26 Jun 2000. Philip Morris. Bates No. 2078738342A/8343. http://legacy.library.ucsf.edu/tid/bga82c00. Accessed May 5, 2004.
61. Brookhart S. Who Owns Your Research? Proposed Changes to OMB Circular a-110 Would Allow FOIA Access to Data. April 1999. http://www.psychologicalscience.org/observer/1999/12_4_1.html. Accessed May 2, 2004.
62. Hornstein DT. Accounting for science: The independence of public research in the new, subterranean administrative law. Law and Contemporary Problems. 2003;66(227):227–246.
63. Shapiro SA. The Information Quality Act and environmental protection: the perils of reform by appropriations rider. William and Mary Environmental Law and Policy Review. 2004;28(2):339–374.
64. Kaiser J. Science and regulation. A White House mandate for more peer review. Science. 2003;301(5638):1307.
65. OMB Watch. Data Quality Challenges. January 21, 2004 2004. http://www.ombwatch.org/article/articleview/1419. Accessed June 11, 2004.
66. OMB Watch. World Health Organization Report Faces Data Quality Challenge. Nov. 19, 2003. http://www.ombwatch.org/article/articleview/1930. Accessed May 2, 2004.
67. Reichhardt T. Concern mounts as US agencies face challenges to data quality. Nature. 2002;416:249–250.[Medline]
68. OMB Watch. Data Quality Challenge Filed against OSTP on Global Warming Info. 2003. http://www.ombwatch.org/article/articleview/1902. Accessed May 2, 2004.
69. OMB Watch. Sodium Consumption Data Quality Challenge. July 9, 2003. http://www.ombwatch.org/article/articleview/1635. Accessed May 2, 2004.
70. U.S. Office of Management and Budget. OMB Proposes Draft Peer Review Standards for Regulatory Science. 2003. http://www.whitehouse.gov/omb/inforeg/peer_review_and_info_quality.pdf. Accessed May 2, 2004.
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