clearing the smoke: a collaboration between academia and a pharmaceutical company steven schroeder,...
TRANSCRIPT
Clearing the Smoke: A collaboration between academia
and a pharmaceutical company
Steven Schroeder, MDCatherine Saucedo
Brian ClarkTrevor Jensen, MD
Presentation Sequence• Background of relations between Pfizer and SCLC—
Schroeder• Early Partnership with Pfizer—Saucedo• Grant proposal review process—Clark• Results of RFP—Jensen• Summary and Q&A--All
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
Annals Article
Schroeder SA. Editorial. Ann Intern Med. 2006;145(10):784-785
SCLC and Pfizer• Regular Contacts• SCLC Partners get Funding (e.g. AAFP)• SAS to Brief Pfizer Staff, but…
EARLY PARTNERSHIP WITH PFIZERCatherine Saucedo
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
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 one—individual institutions and professional associations
--Category two—compliance with Joint Commission core measures
--Category three—state-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
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)
Reviewer Withdraws• Initial expert panel member declined to participate noting
Pfizer Corp’s 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
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)
GRANT PROPOSAL REVIEW PROCESSBrian Clark
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
LOI Review
Score 0-35Reconciled scoring disc. of ≥5 points
RFP Review
Score 0-100
Master Review Sheet
DQRFP
1st ReviewerRFP
2nd Reviewer 1st Score 2nd ScoreAverage
Score Grant ID Organization Name State Program Title Requested Amount LOI Category Category notes
Pfizer Conflict of Interest & Eligibility Notes - for review panel information only.
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5
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RESULTS OF RFPTrevor Jensen
RFP Results• 201 Letters of Intent (LOI)• 42 states, one US territory, one foreign country
Applications Submitted and Funded by State
< 15%
15-20%
20-25%
> 25%
* Numbers indicate applications submitted / funded * Smoking Prevalence from 2008 CDC data
Smoking PrevalenceColor
4 / 1
7 / 2
17 / 5
2 / 1
2 / 1
1 / 1
4 / 1
12 / 2
5 / 2
7 / 1
1 /1
1 / 1
2 /2
9 /2
4 / 1
5 / 1
7 / 3
5 / 1
15 / 3
11 / 3
12 / 1
2 / 1
4 /1
1 / 1
1 / -
3 / 1
5 / -
10 / -
3 / -
5 /-
5 /-
1 /-
1 / -
1 /-
3 /- 1 / -
2 /-
1 /-1 /-
1 /-
D.C. 6 / 1
Puerto Rico 1 / -
India 1 / -
1 / -
1 / -
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
The Joint Commission’s 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
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
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)
Funded Grantees• Of 194 LOIs, 56 chosen to submit full proposals• 39 selected for funding (from 24 different states)
--Category 1—17 grantees (up to $200,000)
--Category 2—10 grantees (up to $50,000)
--Category 3—12 grantees (up to $100,000)• Funding increased from initial commitment of $2 million to
> $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
Table 1: Pfizer Letters of Intent and Funded Programs According to Grant Category 1
Table 1 Category 1 ~ Existing Training Programs LOIs Grants Applications 123 17
States 35 13 Applicant type
Academic hospital 33% 47% Other hospital 27% 35% Guild/Association 13% 18% Non profit 27% --
Targeted providers
Patie
nt
pop
Setti
ng
Physicians 29% 41% Multiple providers 38% 41% Other 33% 18%
Targeted patients
Trai
ning
Primary care 19% 18% Mental health 9% 18% Other/combination 72% 64%
Intervention setting
Inte
rven
tion
Inpatient 13% 41% Outpatient 42% 29.5% Other/multiple 45% 29.5%
Training type3
Established training 62 9 New training 39 7 In person 86 10 Electronic/web 52 14
Program components3
Counseling 53 12 Cessation classes 16 2 Quitline integration 18 4 EMR1 upgrade 21 5 CME2 18 3 Clinic systems upgrade 21 5
1. EMR = electronic medical record2. CME = continuing medical education3. Applications may have more than one training type and program components
Table 2: Pfizer Letters of Intent and Funded Programs According to Grant Category 2
Table 2
Category 2 ~ Joint Commission Quality Measure
LOIs Grants Applications 26 10
States 18 9 Applicant type
Academic 19% 30% Non academic 81% 70% Single hospital 65% 40% Hospital network 35% 60%
Targeted patients
General inpatient 69% 90% Mental health 8% -- Other 23% 10%
Targeted criteria
1 6 3 2 14 5 3 10 3 4 11 5 All 3 2 Unclear 2 --
Program components1
Counseling 20 7 Staff training 14 8 EMR upgrade 11 8 Phone follow up 8 2 Quitline integration 8 5
New tobacco staff 9 3
1. Applications may have more than one program component
Table 3: Pfizer Letters of Intent and Funded Programs According to Grant Category 3
1. SA = Substance Abuse2. EMR = electronic medical record3. CME = continuing medical education4. Applications may have more than one training type and program components
Table 3 Category 3 ~ State-wide Training Programs
LOIs Grants
Applications 45 12 States 25 11
Applicant type
Academic hospital 31% 58% Other hospital 4% -- Guild/association 40% 25% Non profit 24% 17%
Targeted providers
Physicians 13% 17% Multiple providers 36% 75% Other/not specified 51% 8%
Targeted patients
Primary care 9% 8% Mental health / SA1 40% 58% Other / many 51% 34%
Intervention setting
Clinic 33% 50% Mental health facility 4% 17% Other/not specified 63% 33%
Training type4
Inte
rven
tions
Established training 29 10 New training 12 2 In person 38 12 Electronic/web 13 3
Program components4
Counseling 29 12 Cessation classes 16 2 Quitline integration 13 5 EMR2 upgrade 2 2 CME3 6 4 Clinic systems upgrade 5 1
Q and A