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.

1

2

3

4

5

6

7

8

9

10

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