1. Legislating “Sound Science”: The Data Access and Data Quality Laws Annamaria Baba, MPH Daniel Cook, PhD Tom McGarity, JD Lisa Bero, PhD

2. Background –Data Access Act 1998 Freedom of Information of Act (FOIA) applies to data produced under a federally funded grant - formerly only data possessed by federal agency. Freedom of Information of Act (FOIA) applies to data produced under a federally funded grant - formerly only data possessed by federal agency. Federal agency funding the study is required to obtain the raw data from the grantee if a request is made. Federal agency funding the study is required to obtain the raw data from the grantee if a request is made.

3. Background – Data Access Act 1998 Major scientific and academic research groups voiced concerns (NAS, AAAS) Major scientific and academic research groups voiced concerns (NAS, AAAS)  Confidentiality of medical information.  Discouragement of research subjects.  Misinterpretation of incomplete or prematurely released data sets.  Delay of research and policies.

4. Data Quality Act 2000 Information disseminated by federal agencies must meet standards for: Information disseminated by federal agencies must meet standards for:  Objectivity  Utility  Integrity  Influential data – “scientific, financial, statistical information that will have or does have a clear and substantial impact on public policies must be reproducible”.  Peer review insufficient.

5. Background- Data Quality Act 2000 Individual federal agencies are to: Individual federal agencies are to:  Follow guidelines from OMB.  Establish mechanism for correction of information.  Report to the government the number and nature of complaints received.

6. Data Access and Data Quality Introduced as a couple of paragraphs each at the last minute as amendments into Omnibus Appropriations Acts. Introduced as a couple of paragraphs each at the last minute as amendments into Omnibus Appropriations Acts.  Requires OMB to guide federal agencies. No legislative hearing, committee review, or debate. No legislative hearing, committee review, or debate. Industry driven efforts that have the potential for misuse. Industry driven efforts that have the potential for misuse.

7. Tobacco and Data Access May, 1996 – Philip Morris meeting notes. May, 1996 – Philip Morris meeting notes. “Acquisition of data is a major goal for Philip Morris”. Strategies used to obtain data: Strategies used to obtain data:  Direct requests to researchers for data.

9. Tobacco and Data Access May, 1996 – Philip Morris meeting notes. May, 1996 – Philip Morris meeting notes. “Acquisition of data is a major goal for Philip Morris”. Strategies used to obtain data: Strategies used to obtain data:  Direct requests to researchers for data.  Subpoena researchers for data.  Legislate data access and data quality laws to promote “sound science”.

10. Tobacco and Data Access / Quality Motive Motive  Obtain data and reanalyze or challenge.  Repeal smoking restrictions. Strategy Strategy  EPA outdoor air regulations.  Hide industry involvement.

11. Force Field Analysis - 1997 “The broad base concern regarding EPA’s new outdoor air regulations provides us with a unique and unprecedented opportunity to advance our science policy objectives” “The broad base concern regarding EPA’s new outdoor air regulations provides us with a unique and unprecedented opportunity to advance our science policy objectives”

12. Force Field Analysis “despite requests from Congress and the EPA, the researchers of one of the disputed epidemiological studies on air pollution have refused to make public the underlying data from their study. This is remarkably similar to the ETS issue where the tobacco industry has not been able to get the supporting data from the Fontham study …” “despite requests from Congress and the EPA, the researchers of one of the disputed epidemiological studies on air pollution have refused to make public the underlying data from their study. This is remarkably similar to the ETS issue where the tobacco industry has not been able to get the supporting data from the Fontham study …”

13. Force Field Analysis “Because of the parallels between the ETS issue and the new clean air regulations, we have an opportunity to direct the established political and business coalitions to focus on meeting our objectives.” “Because of the parallels between the ETS issue and the new clean air regulations, we have an opportunity to direct the established political and business coalitions to focus on meeting our objectives.” “If successful, the plan could ultimately minimize the scientific basis for smoking bans and result in reasonable smoking restriction policies.” “If successful, the plan could ultimately minimize the scientific basis for smoking bans and result in reasonable smoking restriction policies.”

14. “Best Case” Scenario “Federal legislation passes including both criteria for epidemiological studies and a requirement for data sharing.” “Federal legislation passes including both criteria for epidemiological studies and a requirement for data sharing.” “We get data from the Fontham study and prove it does not show any association between ETS and disease.” “We get data from the Fontham study and prove it does not show any association between ETS and disease.” “As a result, smoking ban efforts are either preempted or no longer passed.” “As a result, smoking ban efforts are either preempted or no longer passed.”

15. “Worst Case” Scenario “Data sharing passes and we get access to the Fontham data. However, without established criteria to evaluate our analysis of the data the EPA and other groups discredits our evaluation and our results are ignored.” “Data sharing passes and we get access to the Fontham data. However, without established criteria to evaluate our analysis of the data the EPA and other groups discredits our evaluation and our results are ignored.”

16. “Worst Case” continued … “We do the re-analysis of the Fontham data and an association remains.” “We do the re-analysis of the Fontham data and an association remains.” “Our interest in the EPA rule and our legislative objectives become public knowledge which could prevent / diminish the effectiveness of the legislation.” “Our interest in the EPA rule and our legislative objectives become public knowledge which could prevent / diminish the effectiveness of the legislation.”

17. Help organize coalitions for other epidemiology issues coming up soon (e.g., fishing industry, mercury, Methyline Chloride)

18. Implementation December, 1998 - Jim Tozzi contract with Philip Morris to work on data legislation. December, 1998 - Jim Tozzi contract with Philip Morris to work on data legislation.  Multinational Business Services (MBS).  Center for Regulatory Effectiveness (CRE).

19. MBS Workplan Data Access and Quality December, 1998 December, 1998  Solicit views of federal agency officials.  Draft prototype regulations.  Present and market the drafts to federal agencies.

20. MBS Workplan (cont.):  Brief congressional committee members and staff on MBS’s proposed regulations and elicit their support.  Identify states supportive of MBS’s views and elicit their support.  Build a coalition on data access and data quality with the Center for Regulatory Effectiveness.

22. Implementation December 1998- Federal Focus, Inc. develops “Outreach Program on Data Integrity”. December 1998- Federal Focus, Inc. develops “Outreach Program on Data Integrity”.  Draft language.  Contact organizations in the industry.  Solicit funding from organizations.  Sponsor symposiums and conferences.

24. Implementation – Data Quality January, 2000 – letter from Jim Tozzi to OMB – draft data quality guidelines. January, 2000 – letter from Jim Tozzi to OMB – draft data quality guidelines. February, 2000 – Jim Tozzi sends PM a “schedule of events” for data quality. February, 2000 – Jim Tozzi sends PM a “schedule of events” for data quality.  Discussion with industry stakeholders on the draft.  Discussions with federal agencies.

25. Data Quality- Implementation  “Interactive Docket”.  Presentation of draft regulation to the Administration.  Adoption of data quality regulations by OMB or initiation of judicial action.

26. Using the Data Quality Act Petitions filed challenging data used to create policies and regulations. Petitions filed challenging data used to create policies and regulations.  National Assessment on Climate Change.  Dietary guidelines issued by the WHO.  NIH report regarding sodium consumption and blood pressure.  Fact sheet on smokeless tobacco.

27. What’s next? OMB used Data Quality Act as the basis for developing revised peer review standards. OMB used Data Quality Act as the basis for developing revised peer review standards. Peer review revisions are “part of an ongoing effort to improve the quality, objectivity, utility, and integrity of information disseminated to the public”. Peer review revisions are “part of an ongoing effort to improve the quality, objectivity, utility, and integrity of information disseminated to the public”.

28. Conclusion Need for more transparency about the involvement of industry in legislative and regulatory activities. Need for more transparency about the involvement of industry in legislative and regulatory activities.  Intent of the legislation or regulation.  Role in drafting language.  Role in gathering and providing commentary.