Transcript Helping Clinicians Do the Right Thing Results of the first

Clearing the Smoke:
A collaboration between academia
and a pharmaceutical company
Steven Schroeder, MD
Catherine Saucedo
Brian Clark
Trevor 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 PFIZER
Catherine 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 PROCESS
Brian 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 0-35
Reconciled scoring disc. of ≥5 points
RFP Review
Score 0-100
Master Review Sheet
DQ
1
2
3
4
5
6
7
8
9
10
RFP
RFP
1st Reviewer 2nd Reviewer
1st Score
2nd Score
Average
Score
Pfizer Conflict of
Interest &
Eligibility Notes for review panel
information
only.
Grant ID
Organization Name
State
Program Title
Requested Amount LOI Category
Category notes
RESULTS OF RFP
Trevor Jensen
RFP Results
• 201 Letters of Intent (LOI)
• 42 states, one US territory, one foreign country
Applications Submitted and Funded by State
1 /-
7/2
1 /4 /1
1 /-
4/1
1/-
15 / 3
5/-
10 / 17 / 5
5/2
1 /1
11 / 3
7/
1
7/
1 /3-
3 /-
4 /1
5 /-
1 /5/1
1/-
3/1
2/1
1/1
2 /-
12 / 1
1/1
5/1
9 /2
3/-
D.C. 6 / 1
Puerto Rico 1 / -
India 1 / Color
Smoking Prevalence
2 /2
< 15%
15-20%
5 /-
2/1
20-25%
1 /1/-
12 / 2
1/1
1/> 25%
2/1
4/1
* Numbers indicate applications submitted / funded
* Smoking Prevalence from 2008 CDC data
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
Interv
entio
n
Traini
ng
Settin
g
Patie
nt
pop
Applications
States
Applicant type
Academic hospital
Other hospital
Guild/Association
Non profit
Targeted providers
Physicians
Multiple providers
Other
Targeted patients
Primary care
Mental health
Other/combination
Intervention setting
Inpatient
Outpatient
Other/multiple
3
Training type
Established training
New training
In person
Electronic/web
3
Program components
Counseling
Cessation classes
Quitline integration
1
EMR upgrade
2
CME
Clinic systems upgrade
LOIs
123
35
Grants
17
13
33%
27%
13%
27%
47%
35%
18%
--
29%
38%
33%
41%
41%
18%
19%
9%
72%
18%
18%
64%
13%
42%
45%
41%
29.5%
29.5%
62
39
86
52
9
7
10
14
53
16
18
21
18
21
12
2
4
5
3
5
1. EMR = electronic medical record
2. CME = continuing medical education
3. 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
Applications
States
Applicant type
Academic
Non academic
Single hospital
Hospital network
Targeted patients
General inpatient
Mental health
Other
Targeted criteria
1
2
3
4
All
Unclear
1
Program components
Counseling
Staff training
EMR upgrade
Phone follow up
Quitline integration
New tobacco staff
LOIs
26
18
Grants
10
9
19%
81%
65%
35%
30%
70%
40%
60%
69%
8%
23%
90%
-10%
6
14
10
11
3
2
3
5
3
5
2
--
20
14
11
8
8
7
8
8
2
5
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
Table 3
Category 3 ~ State-wide Training Programs
Interven
tions
Applications
States
Applicant type
Academic hospital
Other hospital
Guild/association
Non profit
Targeted providers
Physicians
Multiple providers
Other/not specified
Targeted patients
Primary care
1
Mental health / SA
Other / many
Intervention setting
Clinic
Mental health facility
Other/not specified
4
Training type
Established training
New training
In person
Electronic/web
4
Program components
Counseling
Cessation classes
Quitline integration
2
EMR upgrade
3
CME
Clinic systems upgrade
LOIs
45
25
Grants
12
11
31%
4%
40%
24%
58%
-25%
17%
13%
36%
51%
17%
75%
8%
9%
40%
51%
8%
58%
34%
33%
4%
63%
50%
17%
33%
29
12
38
13
10
2
12
3
29
16
13
2
6
5
12
2
5
2
4
1
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
Q and A