Transparency in Grants and Gifts

Pfizer Approach

Cathryn Clary, MD VP, US External Medical Affairs

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Evolving EnvironmentEvolving Environment

PhRMA Code on Interaction with Health Care Professionals2002

OIG HHS Compliance Program Guide for Pharmaceutical Manufacturers

AdvaMed Code of Ethics on Interactions with Health Care Professionals

2003

ACCME Updated Standards for Commercial Support

Conjoint Committee CME Task Force Recommendations2004

Pfizer created Medical Education Grants Group in Medical

ACCME Revised Accreditation Standards2006

Senate Finance Committee Report on Use of Educational Grants by Pharmaceutical Manufacturers2007

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Accelerating Pace of ScrutinyAccelerating Pace of Scrutiny

Macy Foundation Recommendations on Continuing Education in the Health Professions

Senate Finance Committee association inquiry letter

Senator Grassley letter to major pharmaceutical companies (Feb 26, 2008)

AAMC Task Force reports on industry support of education

CEJA AMA report

IOM conflict of interest report anticipated

Sunshine Act legislation introduced in Congress

2008

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Industry Response to Move Towards Greater TransparencyIndustry Response to Move Towards Greater Transparency

Now established: FDA financial disclosure (longstanding) Clinical trial registration (FDAAA expanded remit) Clinical trial results (FDAAA drastically expanded remit) Compound pipelines

Emerging: Post-marketing commitments (Pfizer) Greater transparency about safety information Payments for continuing medical education and to

patient associations and medical groups (Eli Lilly, Pfizer, others following shortly)

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Opportunities Are Inherent in Greater TransparencyOpportunities Are Inherent in Greater Transparency

Enhance understanding of pharmaceutical industry commitment and responsiveness

Broaden visibility of industry partnerships and collaborations with other healthcare groups to advance health

Promote trust

Mediate skepticism and cynical perception of industry

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Pfizer Transparency Efforts Pfizer Transparency Efforts

Pfizer begins publicly reporting its U.S. political contributions.

Pfizer begins registering trials on clinicaltrials.gov (> 800 trials registered to date).

Pfizer begins publicly posting clinical trial results on clinicalstudyresults.org. As of 2005, results of all patient studies (Phase I and beyond) are posted.

Pfizer begins disclosing information on its drug development pipeline on Pfizer.com.

Pfizer begins reporting its U.S. post marketing commitments on Pfizer.com.

Pfizer announces intention to disclose its grants & charitable contributions.

Pfizer begins reporting its grants & charitable contributions on Pfizer.com.

20022002

20042004

20062006

April 2007April 2007

May 14, 2008 May 14, 2008

June 2007June 2007

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Web Page: Under ‘Responsibility’ Tab on Pfizer.comWeb Page: Under ‘Responsibility’ Tab on Pfizer.com

Description of grants: Name of recipient

organization Project description / title Amount of payment

Data published quarterly

Explanatory text: Home Page, describing scope

of data and commitment to transparency

Descriptions of Funding Types and Recipient Organizations

Frequently Asked Questions Statement on Transparency in

Grants

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What Are We Disclosing?What Are We Disclosing?

Grants ≥$500 to U.S. medical, scientific and patient organizations

Charitable contributions ≥$500

Examples include: Medical Education Group grants Fellowship/scholarship support to institutions (not

individuals) Grants/contributions to patient organizations Grants/contributions to medical & scientific associations Grants/contributions to academic and other medical

centers Link to Pfizer Foundation IRS 990 filings

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Illustrative Key Contributions:1Q 2008Illustrative Key Contributions:1Q 2008

‘CS2day’ (Medical Education) 3-year HCP education initiative to reduce smoking and improve

public health $3.4 million to California Academy of Family Physicians and 8

partner organizations nationwide

Malaria patient education and treatment $500,000 to Family Health International

Clinical Investigator Training Program with MIT and Beth Israel Deaconess Medical Center $237,500 to Massachusetts Institute of Technology

New York Hispanic/Latino Outreach Program $100,000 to Patient Advocate Foundation

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Response to Publication of Grant and Gift DisclosureResponse to Publication of Grant and Gift Disclosure

Media: Coverage by Bloomberg, industry media, and blogs generally

positive“The Pfizer transparency initiative should be a model for industry.”

– Mark Senak, Eye on FDA blog

Recipient Organizations: 100% supportive response after notification of ~750 recipient

organizations“You have all done a tremendous job putting this together,

congratulations. We look forward to working with you all on this issue.” – National Health Council

“Thank you for the opportunity to publicly endorse Pfizer’s new transparency policy and grant activity posting. You, your colleagues and organization are to be commended.” – Easter Seals

Within Pfizer:“Detailing these grants and charitable contributions is an important part

of our ongoing transparency drive.”

– Jeffrey Kindler, Chairman & CEO

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What’s Next?What’s Next?

Operationalizing process and securing resources to sustain the effort

Considering standardized customer-facing websites to facilitate grant and contribution applications

Discussing potential expansions in scope of project: Grants and charitable contributions to non-patient, non-

medical, non-scientific organizations U.S. initiative establishes momentum for Pfizer ex-U.S.

transparency efforts

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Questions?