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Different hats, same needs:
Marketing compliance from
doctor’s office to boardroom
        Jonathan M. Sackier
            May 4, 2011
   2011 Pharma Marketing Summit
“Nothing political is correct”
Are you paying attention?
“When teachers are speaking, only 11% are
  paying attention, 23% are thinking about
  personal issues and 66% are having a
  sexual fantasy.” (Rod Machado)

If this holds true, regardless of what I say at
   least 2/3 of us will be having fun!
Goals for today
Understand why Good Promotional
Practices serve all constituencies and….
Structure
Establish my bona fides and viewpoint
What do I, representing different
constituencies, want and need?
Provide four groups of suggestions
I need your help…
no longer elbow-deep-in-gore,
but still need timely, focused &
accurate product information
 Teach at UVA
 Supervise research
 Lecture and write
 AOPA Medical Counsel
Healthcare philanthropy/social activism

 First Star
 Montel Williams MS Foundation
 Foundation for Surgical Fellowship
 Board of the American College of Surgeons
 Foundation
 Presidents Council of AOPA
….all involve interaction with the
 pharmaceutical, biotechnology & medtech
 sectors
Consumer – they used to call us
          patients
Entrepreneurial recidivist
Board member/advisor
“you don’t need to know that Jonathan…”
       Adenosine Therapeutics - sale to CLDA/Forest



                Drug discovery and safety

                IP identification/market intelligence



          Enabling the paralyzed to walk again




         Support Good Promotional Practices
A bumper crop ……. of settlements
      in promotional wrongdoing
 Forest - $313m
 Novartis - $422.5m

“…prosecuting pharma executives for
  misdemeanors is on the cards” (Eric
  Blumberg, FDA Deputy Chief for
  Litigation)
  Allergan $600m (I can’t go for that no can
  do)
Tell ‘em….
Compliance is the new dirty word, real dirty
I come at this from several perspectives
Lay of the land
Four solutions:

Turning your sales reps into information
concierges;
Use of content management systems;
Good Promotional Practices ;
Form & support product information exchanges
Lay of the land




What do doctors want?
What do companies want?
What do directors want?
What do doctors want?
Reliable, digestible information delivered in a
sensitive, timely & efficient manner
Make their patients happy
Treated with respect
Partnership with integrity
Balance the books
Get some time back
Avoid aggravation
What do companies want?
Sales to…
…generate profits…
….to create jobs, reward investors and
fund future products
New compounds; IP span; trial;
compliance; retention…..
Avoid aggravation
What do directors want?
Intellectual success while having….
…fun and if that pans out then…
…financial rewards
Avoid aggravation….
So given these alignments,
              why…
…is there so much aggravation?
“God, grant me the serenity to
accept the things I cannot
change, the courage to change
the things I can and the wisdom
to know the difference.”
(Reinhold Niebuhr)
The things I cannot change (probably)
Patent life
New blockbuster
compound
Doctor’s working day
The competition
Human behavior
The regulations
The things I can change
          (possibly)
Conflict of interest & Good Promotional
Practices debate
How physicians view your company
How you present yourself to physicians
What you present to physicians
The relationships you fashion
The attention to detail for good
promotional practice
The wisdom to know the
           difference
The facts speak for themselves:
 Pens and paper, meals and trips
 CME
 Conflict of interest
 Price controls
 Fair balance
…..and on, and on

Good Promotional Practices are the
solution!
The wisdom to know the difference: an
          aviation parallel
                       Digital fuel gauge
                       Backup digital fuel
                       gauge
                       Analog fuel gauge
                       Backup analog fuel
                       gauge
                       On-board computer
                       Look in the tanks!!
Four actionable strategies
Turning your sales reps into
information concierges;
Use of content management systems;
Good Promotional Practices ;
Form & support product information
exchanges
1. Transform your sales reps into
        information concierge




There when you want them
Situation-appropriate & compliant material
Make things happen
No lies, no alibis
Who are your reps talking to?
Not your father’s doctor…
More are female
180,000 are FMG’s (1/4) and growing
Increasing debt on graduation
Average first year income (age 33) is
$120K, but…….
Golf?
Secretarial assistance?
Fancy lifestyle?
“I feel like the frog in the pan. The temperature on the stove has
been turned up degree by degree. And being the over-achiever I
am, I have accommodated to each escalation to the point of
looking around to see the water boiling all around me. The
demands for menial record-keeping mandates keeping me from
what I am better qualified and prepared to do, and the gate-
keeping milieu has clipped my capacity to soar to where I have
had adequate flight training!”
Rep behavior

Best use of time?
What defines prescribing habits?
Who specifically is your target audience?
What do your reps know about the
medical literature?
What do the doctors know?
Target audience
Devices vs pharma?
DNA with PAP
Typical pharma ad
Personalize your material
and presentation
Good reprint practices
What do your reps know?
Medical literature how to
read and use
The content of the
literature is complex
The structure of medical
literature is becoming
more complex
Your reps time with
doctors is ever more
valuable
The rules are changing…
…..the more they
understand, the more
confident they will be in
your job.
How do physicians read the
      medical literature?

Osmosis
Scan titles, names,
institutions
Read abstracts
Compass rose
Data in abstracts of published
           research articles
           .

• Abstract most likely part of article read, so it must reflect the article
• Random 44 articles 7/1/96 – 6/30/97: Ann Int Med, BMJ, JAMA, Lancet, &
NEJM & 44 articles 7/1/96 – 8/15/97: CMAJ
• Proportion of deficient abstracts varied 18%-68%. Statistically significant
degree (P<.001) among the 6 journals studied.
• Deficiency either lack of concordance, omission of data or both
• Abstract: “population consisted of 42 consecutive patients" Body "44
consecutive patients of which 42 agreed to participate."
• Abstract: “estimated 15-year survival 48%” Body: “58%.”
Pitkin RM, Branagan A, Burmeister LF JAMA. 1999;281:1110-1111
Parachute use to prevent death and major trauma related to
     gravitational challenge: systematic review of randomised
                          controlled trials
                     Smith GCS, Jill P Pell JP
                     BMJ 2003; 327:1459 - 1461
Objectives To determine whether parachutes are
effective in preventing major trauma related to
gravitational challenge.
 Design Systematic review of randomised controlled
trials.
Data sources: Medline, Web of Science, Embase,
Cochrane Library databases; appropriate websites &
citation lists.
Study selection: Studies showing the effects of using a
parachute during free fall.
Main outcome measure Death or major trauma, defined
as an injury severity score > 15.
Results We were unable to identify any randomised
controlled trials of parachute intervention.
Conclusions As with many interventions intended to
prevent ill health, the effectiveness of parachutes has not
been subjected to rigorous evaluation of randomised
controlled trials. Advocates of evidence based medicine
have criticised the adoption of interventions evaluated by
using only observational data. Everyone might benefit if
the most radical protagonists of evidence based medicine
organised and participated in a double blind, randomised,
placebo controlled, crossover trial of the parachute.
Solutions:
Publication & presentation strategy – think
it through. Curealldiseaseallol – plan, plan,
plan some more. And planning does not
stop with launch….
Train reps how to read & use the literature
to suit yours and doctor’s needs
Internal journal club
Challenge conventional wisdom on
reprints
Four actionable strategies
Turning your sales reps into information
concierges;
Use of content management systems;
Good Promotional Practices;
Form & support product information
exchanges
2. Use content management systems

A day in the life of a doctor
The round file
Compliance rules are complex and getting
more so
International standards – highest should
apply
Belt and braces – use everything that
might help
Strategies: Data

Data acquisition for regulatory approval
insufficient for payor approval. EBM is the order of
the day
Where you do your studies: best markets
Who does your studies – it really does matter who
you know …. and who they know!
Where and when you publish/present. And follow
– on publications
Look at NICE, HTA, iTAPP
Rep support
 Getting in the door is step 1
 Before (database assets)
 During (presentation assets)
 After (permission-based marketing, GPP)

Buy off on GPP? Buy off on Rep v2.0. This
 truth is self-evident!
Four actionable strategies
Turning your sales reps into information
concierges;
Use of content management systems;
Good Promotional Practices;
Form & support product information
exchanges
3. Good Promotional Practices
               Where has all the trust gone?”
               “Where have all the ethics
“              gone?”
               This new world of compliance
               presents you with
               opportunities as well as
               threats
               If you engage with GPP now,
               you help define the space.
               The “flexible” marketing
               budget
               Jollying along reps
               “I didn’t know…..”
               Don’t be silent, speak up
Other actions?
Check out
www.goodpromotionalpractices.com
No, on second thoughts, contribute to
www.goodpromotionalpractices.com
Four actionable strategies
Turning your sales reps into information
concierges;
Use of content management systems;
Good Promotional Practices;
Form & support product information
exchanges
4. Form & support initiatives to bridge
         the information gap
                    Journal ads? DTC TV
                    ads?
                    We know about CME,
                    what about UME, GME?
                    Own media landscape?
                    Episodic bombardment?
                    No, become the trusted
                    purveyor, the concierge
                    motivated by good
                    promotional practices
“Consortium” Mark
Handforst
Ethics & good promotional
               practices
I have heard it said that human beings are
   inherently corrupt so sadly you need
   systems to remind and prevent them from
   doing wrong. It is you who will pay the
   fines/settlements. Or go to prison.

Let us systematically institutionalize the
  culture of intent – good promotional
  practices protect all constituencies.
Primum non nocere




Maybe Good Promotional Practices could
 become the Declaration of Geneva or
 Hippocratic oath for healthcare marketing?
Pharmaceutical industry
  Employs: over 600,000 people and supports 3m
  Advances science & invests: > $60B
  Contributes to tax base & exports: $23B NJ
  alone
  Saves lives…..mine included, so thank you.

Lets stop apologizing for our industry and proudly
  proclaim our value….while dealing swiftly and
  transparently with miscreants
“Do the right thing”
“Everything is for the
patient”
“Ready, fire, aim!”
Good Promotional Practices: The
       culture of intent
The times they are a’changin
Compliance is an opportunity as well as a
threat
When the going gets tough, the tough go
shopping
Accept that the medical landscape is
changing and stay ahead of the curve
Good Promotional Practices are not only the
wise thing to do, they are the right thing to do!
The world according to Rush (not
         Limbaugh)…
                   You can choose a ready
                  guide in some celestial
                  voice.
                  If you choose not to
                  decide, you still have
                  made a choice.
                  You can choose from
                  phantom fears and
                  kindness that can kill;
                  I will choose a path that's
                  clear-
                  I will choose Free Will.
Thank you
Jonathan M. Sackier
jonathan@pshcconsulting.com
P: (434) 245 8801
F: (434) 245 8804
C: (434) 566 3061

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Different hats, same needs: Marketing compliance from doctor’s office to boardroom

  • 1. Different hats, same needs: Marketing compliance from doctor’s office to boardroom Jonathan M. Sackier May 4, 2011 2011 Pharma Marketing Summit
  • 3. Are you paying attention? “When teachers are speaking, only 11% are paying attention, 23% are thinking about personal issues and 66% are having a sexual fantasy.” (Rod Machado) If this holds true, regardless of what I say at least 2/3 of us will be having fun!
  • 4. Goals for today Understand why Good Promotional Practices serve all constituencies and….
  • 5. Structure Establish my bona fides and viewpoint What do I, representing different constituencies, want and need? Provide four groups of suggestions
  • 6. I need your help… no longer elbow-deep-in-gore, but still need timely, focused & accurate product information Teach at UVA Supervise research Lecture and write AOPA Medical Counsel
  • 7. Healthcare philanthropy/social activism First Star Montel Williams MS Foundation Foundation for Surgical Fellowship Board of the American College of Surgeons Foundation Presidents Council of AOPA ….all involve interaction with the pharmaceutical, biotechnology & medtech sectors
  • 8. Consumer – they used to call us patients
  • 10. Board member/advisor “you don’t need to know that Jonathan…” Adenosine Therapeutics - sale to CLDA/Forest Drug discovery and safety IP identification/market intelligence Enabling the paralyzed to walk again Support Good Promotional Practices
  • 11. A bumper crop ……. of settlements in promotional wrongdoing Forest - $313m Novartis - $422.5m “…prosecuting pharma executives for misdemeanors is on the cards” (Eric Blumberg, FDA Deputy Chief for Litigation) Allergan $600m (I can’t go for that no can do)
  • 12. Tell ‘em…. Compliance is the new dirty word, real dirty I come at this from several perspectives Lay of the land Four solutions: Turning your sales reps into information concierges; Use of content management systems; Good Promotional Practices ; Form & support product information exchanges
  • 13. Lay of the land What do doctors want? What do companies want? What do directors want?
  • 14. What do doctors want? Reliable, digestible information delivered in a sensitive, timely & efficient manner Make their patients happy Treated with respect Partnership with integrity Balance the books Get some time back Avoid aggravation
  • 15. What do companies want? Sales to… …generate profits… ….to create jobs, reward investors and fund future products New compounds; IP span; trial; compliance; retention….. Avoid aggravation
  • 16. What do directors want? Intellectual success while having…. …fun and if that pans out then… …financial rewards Avoid aggravation….
  • 17. So given these alignments, why… …is there so much aggravation?
  • 18. “God, grant me the serenity to accept the things I cannot change, the courage to change the things I can and the wisdom to know the difference.” (Reinhold Niebuhr)
  • 19. The things I cannot change (probably) Patent life New blockbuster compound Doctor’s working day The competition Human behavior The regulations
  • 20. The things I can change (possibly) Conflict of interest & Good Promotional Practices debate How physicians view your company How you present yourself to physicians What you present to physicians The relationships you fashion The attention to detail for good promotional practice
  • 21. The wisdom to know the difference The facts speak for themselves: Pens and paper, meals and trips CME Conflict of interest Price controls Fair balance …..and on, and on Good Promotional Practices are the solution!
  • 22.
  • 23. The wisdom to know the difference: an aviation parallel Digital fuel gauge Backup digital fuel gauge Analog fuel gauge Backup analog fuel gauge On-board computer Look in the tanks!!
  • 24. Four actionable strategies Turning your sales reps into information concierges; Use of content management systems; Good Promotional Practices ; Form & support product information exchanges
  • 25. 1. Transform your sales reps into information concierge There when you want them Situation-appropriate & compliant material Make things happen No lies, no alibis Who are your reps talking to?
  • 26. Not your father’s doctor… More are female 180,000 are FMG’s (1/4) and growing Increasing debt on graduation Average first year income (age 33) is $120K, but……. Golf? Secretarial assistance? Fancy lifestyle?
  • 27. “I feel like the frog in the pan. The temperature on the stove has been turned up degree by degree. And being the over-achiever I am, I have accommodated to each escalation to the point of looking around to see the water boiling all around me. The demands for menial record-keeping mandates keeping me from what I am better qualified and prepared to do, and the gate- keeping milieu has clipped my capacity to soar to where I have had adequate flight training!”
  • 28. Rep behavior Best use of time? What defines prescribing habits? Who specifically is your target audience? What do your reps know about the medical literature? What do the doctors know?
  • 29. Target audience Devices vs pharma? DNA with PAP Typical pharma ad Personalize your material and presentation Good reprint practices
  • 30. What do your reps know? Medical literature how to read and use The content of the literature is complex The structure of medical literature is becoming more complex Your reps time with doctors is ever more valuable The rules are changing… …..the more they understand, the more confident they will be in your job.
  • 31. How do physicians read the medical literature? Osmosis Scan titles, names, institutions Read abstracts Compass rose
  • 32. Data in abstracts of published research articles . • Abstract most likely part of article read, so it must reflect the article • Random 44 articles 7/1/96 – 6/30/97: Ann Int Med, BMJ, JAMA, Lancet, & NEJM & 44 articles 7/1/96 – 8/15/97: CMAJ • Proportion of deficient abstracts varied 18%-68%. Statistically significant degree (P<.001) among the 6 journals studied. • Deficiency either lack of concordance, omission of data or both • Abstract: “population consisted of 42 consecutive patients" Body "44 consecutive patients of which 42 agreed to participate." • Abstract: “estimated 15-year survival 48%” Body: “58%.” Pitkin RM, Branagan A, Burmeister LF JAMA. 1999;281:1110-1111
  • 33. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials Smith GCS, Jill P Pell JP BMJ 2003; 327:1459 - 1461 Objectives To determine whether parachutes are effective in preventing major trauma related to gravitational challenge. Design Systematic review of randomised controlled trials. Data sources: Medline, Web of Science, Embase, Cochrane Library databases; appropriate websites & citation lists. Study selection: Studies showing the effects of using a parachute during free fall. Main outcome measure Death or major trauma, defined as an injury severity score > 15. Results We were unable to identify any randomised controlled trials of parachute intervention. Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation of randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. Everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.
  • 34. Solutions: Publication & presentation strategy – think it through. Curealldiseaseallol – plan, plan, plan some more. And planning does not stop with launch…. Train reps how to read & use the literature to suit yours and doctor’s needs Internal journal club Challenge conventional wisdom on reprints
  • 35. Four actionable strategies Turning your sales reps into information concierges; Use of content management systems; Good Promotional Practices; Form & support product information exchanges
  • 36. 2. Use content management systems A day in the life of a doctor The round file Compliance rules are complex and getting more so International standards – highest should apply Belt and braces – use everything that might help
  • 37. Strategies: Data Data acquisition for regulatory approval insufficient for payor approval. EBM is the order of the day Where you do your studies: best markets Who does your studies – it really does matter who you know …. and who they know! Where and when you publish/present. And follow – on publications Look at NICE, HTA, iTAPP
  • 38. Rep support Getting in the door is step 1 Before (database assets) During (presentation assets) After (permission-based marketing, GPP) Buy off on GPP? Buy off on Rep v2.0. This truth is self-evident!
  • 39. Four actionable strategies Turning your sales reps into information concierges; Use of content management systems; Good Promotional Practices; Form & support product information exchanges
  • 40. 3. Good Promotional Practices Where has all the trust gone?” “Where have all the ethics “ gone?” This new world of compliance presents you with opportunities as well as threats If you engage with GPP now, you help define the space. The “flexible” marketing budget Jollying along reps “I didn’t know…..” Don’t be silent, speak up
  • 41. Other actions? Check out www.goodpromotionalpractices.com No, on second thoughts, contribute to www.goodpromotionalpractices.com
  • 42.
  • 43. Four actionable strategies Turning your sales reps into information concierges; Use of content management systems; Good Promotional Practices; Form & support product information exchanges
  • 44. 4. Form & support initiatives to bridge the information gap Journal ads? DTC TV ads? We know about CME, what about UME, GME? Own media landscape? Episodic bombardment? No, become the trusted purveyor, the concierge motivated by good promotional practices “Consortium” Mark Handforst
  • 45. Ethics & good promotional practices I have heard it said that human beings are inherently corrupt so sadly you need systems to remind and prevent them from doing wrong. It is you who will pay the fines/settlements. Or go to prison. Let us systematically institutionalize the culture of intent – good promotional practices protect all constituencies.
  • 46. Primum non nocere Maybe Good Promotional Practices could become the Declaration of Geneva or Hippocratic oath for healthcare marketing?
  • 47. Pharmaceutical industry Employs: over 600,000 people and supports 3m Advances science & invests: > $60B Contributes to tax base & exports: $23B NJ alone Saves lives…..mine included, so thank you. Lets stop apologizing for our industry and proudly proclaim our value….while dealing swiftly and transparently with miscreants
  • 48. “Do the right thing” “Everything is for the patient” “Ready, fire, aim!”
  • 49. Good Promotional Practices: The culture of intent The times they are a’changin Compliance is an opportunity as well as a threat When the going gets tough, the tough go shopping Accept that the medical landscape is changing and stay ahead of the curve Good Promotional Practices are not only the wise thing to do, they are the right thing to do!
  • 50. The world according to Rush (not Limbaugh)… You can choose a ready guide in some celestial voice. If you choose not to decide, you still have made a choice. You can choose from phantom fears and kindness that can kill; I will choose a path that's clear- I will choose Free Will.
  • 51. Thank you Jonathan M. Sackier jonathan@pshcconsulting.com P: (434) 245 8801 F: (434) 245 8804 C: (434) 566 3061