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

Legislating “Sound Science”: The Data Access and Data

Quality Laws

Annamaria Baba, MPHAnnamaria Baba, MPH

Daniel Cook, PhDDaniel Cook, PhD

Tom McGarity, JDTom McGarity, JD

Lisa Bero, PhDLisa Bero, PhD

Background –Data Access Act 1998

Freedom of Information of Act (FOIA) Freedom of Information of Act (FOIA) applies to data produced under a federally applies to data produced under a federally funded grant - formerly only data possessed funded grant - formerly only data possessed by federal agency.by federal agency.

Federal agency funding the study is Federal agency funding the study is required to obtain the raw data from the required to obtain the raw data from the grantee if a request is made.grantee if a request is made.

Background – Data Access Act 1998

Major scientific and academic research Major scientific and academic research groups voiced concerns (NAS, AAAS)groups voiced concerns (NAS, AAAS) Confidentiality of medical information.Confidentiality of medical information. Discouragement of research subjects.Discouragement of research subjects. Misinterpretation of incomplete or Misinterpretation of incomplete or

prematurely released data sets.prematurely released data sets. Delay of research and policies.Delay of research and policies.

Data Quality Act 2000

Information disseminated by federal agencies must Information disseminated by federal agencies must meet standards for:meet standards for: ObjectivityObjectivity UtilityUtility Integrity Integrity Influential data – “scientific, financial, statistical Influential data – “scientific, financial, statistical

information that will have or does have a clear information that will have or does have a clear and substantial impact on public policies must be and substantial impact on public policies must be reproducible”. reproducible”.

Peer review insufficient.Peer review insufficient.

Background- Data Quality Act 2000

Individual federal agencies are to:Individual federal agencies are to: Follow guidelines from OMB.Follow guidelines from OMB. Establish mechanism for correction of Establish mechanism for correction of

information.information. Report to the government the number and Report to the government the number and

nature of complaints received.nature of complaints received.

Data Access and Data Quality

Introduced as a couple of paragraphs each at the Introduced as a couple of paragraphs each at the last minute as amendments into Omnibus last minute as amendments into Omnibus Appropriations Acts.Appropriations Acts. Requires OMB to guide federal agencies.Requires OMB to guide federal agencies.

No legislative hearing, committee review, or No legislative hearing, committee review, or debate.debate.

Industry driven efforts that have the potential for Industry driven efforts that have the potential for misuse.misuse.

Tobacco and Data Access May, 1996 – Philip Morris meeting notes.May, 1996 – Philip Morris meeting notes.

““Acquisition of data is a major goal for Acquisition of data is a major goal for Philip Morris”.Philip Morris”.

Strategies used to obtain data:Strategies used to obtain data: Direct requests to researchers for data. Direct requests to researchers for data.

Tobacco and Data Access May, 1996 – Philip Morris meeting notes.May, 1996 – Philip Morris meeting notes.

““Acquisition of data is a major goal for Acquisition of data is a major goal for Philip Morris”.Philip Morris”.

Strategies used to obtain data:Strategies used to obtain data: Direct requests to researchers for data. Direct requests to researchers for data. Subpoena researchers for data.Subpoena researchers for data. Legislate data access and data quality Legislate data access and data quality

laws to promote “sound science”.laws to promote “sound science”.

Tobacco and Data Access / Quality MotiveMotive

Obtain data and reanalyze or challenge.Obtain data and reanalyze or challenge. Repeal smoking restrictions. Repeal smoking restrictions.

StrategyStrategy EPA outdoor air regulations.EPA outdoor air regulations. Hide industry involvement.Hide industry involvement.

Force Field Analysis - 1997

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

Force Field Analysis

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

Force Field Analysis

““Because of the parallels between the ETS issue Because of the parallels between the ETS issue and the new clean air regulations, we have an and the new clean air regulations, we have an opportunity to direct the established political opportunity to direct the established political and business coalitions to focus on meeting our and business coalitions to focus on meeting our objectives.”objectives.”

““If successful, the plan could ultimately If successful, the plan could ultimately minimize the scientific basis for smoking bans minimize the scientific basis for smoking bans and result in reasonable smoking restriction and result in reasonable smoking restriction policies.”policies.”

“Best Case” Scenario

““Federal legislation passes including both Federal legislation passes including both criteria for epidemiological studies and a criteria for epidemiological studies and a requirement for data sharing.” requirement for data sharing.”

““We get data from the Fontham study and We get data from the Fontham study and prove it does not show any association prove it does not show any association between ETS and disease.”between ETS and disease.”

““As a result, smoking ban efforts are either As a result, smoking ban efforts are either preempted or no longer passed.”preempted or no longer passed.”

“Worst Case” Scenario

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

“Worst Case” continued …

““We do the re-analysis of the Fontham data We do the re-analysis of the Fontham data and an association remains.”and an association remains.”

““Our interest in the EPA rule and our Our interest in the EPA rule and our legislative objectives become public legislative objectives become public knowledge which could prevent / diminish knowledge which could prevent / diminish the effectiveness of the legislation.”the effectiveness of the legislation.”

Help organize coalitions for otherepidemiology issues coming up soon(e.g., fishing industry, mercury, MethylineChloride)

Implementation

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

(CRE).(CRE).

MBS Workplan Data Access and Quality December, 1998December, 1998

Solicit views of federal agency officials.Solicit views of federal agency officials.

Draft prototype regulations.Draft prototype regulations.

Present and market the drafts to federal Present and market the drafts to federal agencies.agencies.

MBS Workplan (cont.): Brief congressional committee members and Brief congressional committee members and

staff on MBS’s proposed regulations and elicit staff on MBS’s proposed regulations and elicit their support.their support.

Identify states supportive of MBS’s views and Identify states supportive of MBS’s views and elicit their support.elicit their support.

Build a coalition on data access and data quality Build a coalition on data access and data quality with the Center for Regulatory Effectiveness.with the Center for Regulatory Effectiveness.

Implementation

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

Implementation – Data Quality

January, 2000 – letter from Jim Tozzi to January, 2000 – letter from Jim Tozzi to OMB – draft data quality guidelines.OMB – draft data quality guidelines.

February, 2000 – Jim Tozzi sends PM a February, 2000 – Jim Tozzi sends PM a “schedule of events” for data quality.“schedule of events” for data quality.

Discussion with industry stakeholders on Discussion with industry stakeholders on the draft.the draft.

Discussions with federal agencies. Discussions with federal agencies.

Data Quality- Implementation

““Interactive Docket”.Interactive Docket”. Presentation of draft regulation to the Presentation of draft regulation to the

Administration.Administration. Adoption of data quality regulations by Adoption of data quality regulations by

OMB OMB oror initiation of judicial action. initiation of judicial action.

Using the Data Quality Act

Petitions filed challenging data used to Petitions filed challenging data used to create policies and regulations.create policies and regulations. National Assessment on Climate Change.National Assessment on Climate Change. Dietary guidelines issued by the WHO.Dietary guidelines issued by the WHO. NIH report regarding sodium NIH report regarding sodium

consumption and blood pressure.consumption and blood pressure. Fact sheet on smokeless tobacco.Fact sheet on smokeless tobacco.

What’s next?

OMB used Data Quality Act as the basis for OMB used Data Quality Act as the basis for developing revised peer review standards.developing revised peer review standards.

Peer review revisions are “part of an Peer review revisions are “part of an ongoing effort to improve the quality, ongoing effort to improve the quality, objectivity, utility, and integrity of objectivity, utility, and integrity of information disseminated to the public”.information disseminated to the public”.

Conclusion

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

commentary.commentary.