Steven Schroeder, MD

1
Clearing the Smoke A collaboration between
academia and a pharmaceutical company

• Steven Schroeder, MD
• Catherine Saucedo
• Brian Clark
• Trevor Jensen, MD

2
Presentation Sequence

• Background of relations between Pfizer and
  SCLCSchroeder
• Early Partnership with PfizerSaucedo
• Grant proposal review processClark
• Results of RFPJensen
• Summary and QA--All

3
Tobacco Control and Big Pharma

• Tension between Public Health and Smoking
  Cessation Camps
• Bad Behavior/Undue Influence of Pharma
• Pharma Now Supporting Much Clinical Research
• Annals Editorial on Varenicline

4
Annals Article
Schroeder SA. Editorial. Ann Intern Med.
2006145(10)784-785
5
SCLC and Pfizer

• Regular Contacts
• SCLC Partners get Funding (e.g. AAFP)
• SAS to Brief Pfizer Staff, but

6
Early partnership with Pfizer

• Catherine Saucedo

7
Importance of Champions

• Pfizer
• Collin Watson, Associate Director, Neuroscience
  RMRS
• Jackie Mayhew, Director of Medical Education
  Grants/Independent Grant Learning Center (IGLC)
• Interest in SCLC partnership model
• Pfizer and SCLC create the fundamentals
• short turn around from concept to funding

8
Terms of Engagement

• Pfizer
• Legal department to review agreement
• One Pfizer representative on review committee
• SCLC
• Develop RFP
• 3 categories over 1-2 years
• --Category oneindividual institutions and
  professional associations
• --Category twocompliance with Joint Commission
  core measures
• --Category threestate-based behavioral health
  efforts
• Designate size of grants within each category
• Design and administer evaluation
• Select review committee
• Create system for evaluation
• Receive no compensation from Pfizer
• SCLC Funders must agree

9
Review Committee

• SCLC identified potential reviewers
• Members could not have a current Pfizer grant
• None of the final members, excepting Pfizer,
  received compensation
• Steve Bernstein, MD (Emergency Medicine
  Professor, Yale)
• Ken Duckworth, MD (Medical Director of National
  Alliance of Mental Illness)
• Karen Hudmon, Pharm D (Professor of Pharmacy at
  Purdue College of Pharmacy)
• Geoffrey Makinson, PhD (Medical Affairs Director
  at Pfizer)
• Catherine Saucedo (Deputy Director, SCLC)
• Steve Schroeder, MD (Director, SCLC)

10
Reviewer Withdraws

• Initial expert panel member declined to
  participate noting Pfizer Corps prior support of
  Heartland Institute
• Heartland Institute promoted skepticism about
  man-made climate change and the linkage between
  smoking and poor health
• Pfizer IGLC team was unaware of corporate
  involvement
• No oil company execs on Pfizer Corp board
• Resulted in Pfizer indicating they will make no
  2013 contribution to Heartland

11
Collaboration Continues

• SCLC has volunteered to serve as technical
  assistance advisors for the 39 grantees
• Regular one-on-one calls with PI and grant
  project team
• Networking opportunities for each category
• Group conference calls
• Dedicated web page
• Specialty topic areas for grantees to join
• Midpoint and final project survey data to be
  collected
• Fall 2013 conference SCLC to lead designation of
  conference organizer (300,000)

12
Grant proposal review process

• Brian Clark

13
Grant Proposal Review Process

• Freedom re review process
• Utilization of Dropbox as storage for review
  scores and proposals
• Excel to live-update review scores
• Primary/Secondary Reviewers, Reconciliation
• Selection

14
LOI Review
Score 0-35 Reconciled scoring disc. of 5 points
15
RFP Review
Score 0-100
16
Master Review Sheet
17
Results of RFp

• Trevor Jensen

18
RFP Results

• 201 Letters of Intent (LOI)
• 42 states, one US territory, one foreign country

19
Applications Submitted and Funded by State
20
Category 1 (Institutions and Societies)

• Most applicants (123 out of 201)
• Most planned to use previously established
  training programs (FFS, Rx for Change)
• Patient counseling most common component of
  training proposals
• Clinic systems improvement, quitline integration,
  and electronic medical record upgrades

21
The Joint Commissions Smoking Cessation
Performance Measures

• TOB-1 Tobacco Use Screening
• TOB-2 Tobacco Use Treatment Provided or Offered
• TOB-2a Tobacco Use Treatment
• TOB-3 Tobacco Use Treatment Provided or Offered
  at Discharge
• TOB-3a Tobacco Use Treatment at Discharge
• TOB-4 Tobacco Use Assessing Status after
  Discharge

22
Category 2 (Joint Commission)

• Fewest applicants (26)
• Most non-academic single-site hospitals
• General inpatient populations
• Joint Commission quality improvement
• Inpatient treatment (criterion 2) most cited
• Screening (criterion 1) proposed least often
• Staff training, direct patient counseling, and
  electronic medical record upgrades

23
Category 3 (Behavioral Health)

• Majority of applicants medical associations
• Most planned to use established training programs
  for provider cessation counseling or cessation
  courses at multiple sites
• Most engage multiple patient populations
• Multiple programs attempted to integrate existing
  phone quitlines and upgrade electronic medical
  records/clinic systems (also many offered CME
  component)

24
Funded Grantees

• Of 194 LOIs, 56 chosen to submit full proposals
• 39 selected for funding (from 24 different
  states)
• --Category 117 grantees (up to 200,000)
• --Category 210 grantees (up to 50,000)
• --Category 312 grantees (up to 100,000)
• Funding increased from initial commitment of 2
  million to gt 4.5 million due to high volume of
  quality proposals
• Categories 1 3 estimated to train over 6000
  and 2500 providers respectively
• Category 2 equip over 50 hospitals with JC
  quality measure compliant programs

25
Table 1 Pfizer Letters of Intent and Funded
Programs According to Grant Category 1
1. EMR electronic medical record 2. CME
continuing medical education 3. Applications may
have more than one training type and program
components
26
Table 2 Pfizer Letters of Intent and Funded
Programs According to Grant Category 2
1. Applications may have more than one program
component
27
Table 3 Pfizer Letters of Intent and Funded
Programs According to Grant Category 3
1. SA Substance Abuse 2. EMR electronic
medical record 3. CME continuing medical
education 4. Applications may have more than one
training type and program components
28
Q and A