Transparency in Grants and Gifts

1
Transparency in Grants and Gifts

• Pfizer Approach
• Cathryn Clary, MD
• VP, US External Medical Affairs

2
Evolving Environment
2002

• PhRMA Code on Interaction with Health Care
  Professionals

2003

• OIG HHS Compliance Program Guide for
  Pharmaceutical Manufacturers
• AdvaMed Code of Ethics on Interactions with
  Health Care Professionals

2004

• ACCME Updated Standards for Commercial Support
• Conjoint Committee CME Task Force Recommendations

2006

• Pfizer created Medical Education Grants Group in
  Medical
• ACCME Revised Accreditation Standards

2007

• Senate Finance Committee Report on Use of
  Educational Grants by Pharmaceutical Manufacturers

3
Accelerating Pace of Scrutiny
2008

• 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

4
Industry 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)

5
Opportunities 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

6
Pfizer Transparency Efforts

• Pfizer begins publicly reporting its U.S.
  political contributions.
• Pfizer begins registering trials on
  clinicaltrials.gov (gt 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.

2002
2004
2006
April 2007
June 2007
May 14, 2008
7
Web 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

8
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

9
Illustrative Key Contributions1Q 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

10
Response 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 Pfizers 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

11
Whats 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

12
Questions?