different hats, same needs: marketing compliance from doctor’s office to boardroom

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

Jonathan M. SackierJonathan M. Sackier

May 4, 2011May 4, 2011

2011 Pharma Marketing Summit2011 Pharma Marketing Summit

““Nothing political is correct” Nothing political is correct”

Are you paying attention?Are you paying attention?

““When teachers are speaking, only 11% are When teachers are speaking, only 11% are paying attention, 23% are thinking about paying attention, 23% are thinking about personal issues and 66% are having a personal issues and 66% are having a sexual fantasy.” (Rod Machado)sexual fantasy.” (Rod Machado)

If this holds true, regardless of what I say at If this holds true, regardless of what I say at least 2/3 of us will be having fun!least 2/3 of us will be having fun!

Goals for todayGoals for today

Understand why Good Promotional Understand why Good Promotional Practices serve all constituencies and….Practices serve all constituencies and….

StructureStructureEstablish my bona fides and viewpointEstablish my bona fides and viewpoint

What do I, representing different What do I, representing different constituencies, want and need?constituencies, want and need?

Provide four groups of suggestions Provide four groups of suggestions

I need your help…I need your help…

no longer elbow-deep-in-gore, no longer elbow-deep-in-gore, but still need timely, focused & but still need timely, focused & accurate product informationaccurate product information

Teach at UVA Teach at UVA

Supervise researchSupervise research

Lecture and writeLecture and write

AOPA Medical CounselAOPA Medical Counsel

Healthcare philanthropy/social activismHealthcare philanthropy/social activism

First StarFirst StarMontel Williams MS FoundationMontel Williams MS FoundationFoundation for Surgical FellowshipFoundation for Surgical FellowshipBoard of the American College of Surgeons Board of the American College of Surgeons FoundationFoundationPresidents Council of AOPAPresidents Council of AOPA

…….all involve interaction with the .all involve interaction with the pharmaceutical, biotechnology & medtech pharmaceutical, biotechnology & medtech sectorssectors

Consumer – Consumer – they used to call us they used to call us patientspatients

Entrepreneurial recidivist Entrepreneurial recidivist

Board member/advisorBoard member/advisor“you don’t need to know that Jonathan…”“you don’t need to know that Jonathan…”

Adenosine Therapeutics - sale to CLDA/ForestAdenosine Therapeutics - sale to CLDA/Forest

Drug discovery and safetyDrug discovery and safety

IP identification/market intelligence IP identification/market intelligence

Enabling the paralyzed to walk againEnabling the paralyzed to walk again

Support Good Promotional Practices Support Good Promotional Practices

A bumper crop ……. of A bumper crop ……. of settlementssettlementsin promotional wrongdoingin promotional wrongdoing

Forest - $313mForest - $313m

Novartis - $422.5mNovartis - $422.5m

“…“…prosecuting pharma executives for prosecuting pharma executives for misdemeanors is on the cards” (Eric misdemeanors is on the cards” (Eric Blumberg, FDA Deputy Chief for Litigation)Blumberg, FDA Deputy Chief for Litigation)

Allergan $600m (I can’t go for that no can Allergan $600m (I can’t go for that no can do)do)

Tell ‘em….Tell ‘em….Compliance is the new dirty word, real dirtyCompliance is the new dirty word, real dirty

I come at this from several perspectivesI come at this from several perspectives

Lay of the landLay of the land

Four solutions: Four solutions:

1.1. Turning your sales reps into information Turning your sales reps into information concierges;concierges;

2.2. Use of content management systems;Use of content management systems;

3.3. Good Promotional Practices ;Good Promotional Practices ;

4.4. Form & support product information exchangesForm & support product information exchanges

Lay of the landLay of the land

What do doctors want?What do doctors want?What do companies want?What do companies want?What do directors want?What do directors want?

What do doctors want?What do doctors want?Reliable, digestible information delivered in a Reliable, digestible information delivered in a sensitive, timely & efficient mannersensitive, timely & efficient manner

Make their patients happyMake their patients happy

Treated with respectTreated with respect

Partnership with integrityPartnership with integrity

Balance the booksBalance the books

Get some time backGet some time back

Avoid aggravationAvoid aggravation

What do companies want?What do companies want?

Sales to…Sales to…

……generate profits…generate profits…

…….to create jobs, reward investors and .to create jobs, reward investors and fund future productsfund future products

New compounds; IP span; trial; New compounds; IP span; trial; compliance; retention…..compliance; retention…..

Avoid aggravationAvoid aggravation

What do directors want?What do directors want?

Intellectual success while having….Intellectual success while having….

……fun and if that pans out then…fun and if that pans out then…

……financial rewardsfinancial rewards

Avoid aggravation….Avoid aggravation….

So given these alignments, So given these alignments, why…why…

……is there so much aggravation?is there so much aggravation?

““God, grant me the serenity to God, grant me the serenity to accept the things I cannot accept the things I cannot change, the courage to change change, the courage to change the things I can and the wisdom the things I can and the wisdom to know the difference.” to know the difference.” (Reinhold Niebuhr)(Reinhold Niebuhr)

The things I cannot change (probably)The things I cannot change (probably)

Patent lifePatent life

New blockbuster New blockbuster compound compound

Doctor’s working dayDoctor’s working day

The competitionThe competition

Human behaviorHuman behavior

The regulationsThe regulations

The things I can change The things I can change (possibly)(possibly)

Conflict of interest & Good Promotional Conflict of interest & Good Promotional Practices debatePractices debate

How physicians view your companyHow physicians view your company

How you present yourself to physiciansHow you present yourself to physicians

What you present to physiciansWhat you present to physicians

The relationships you fashionThe relationships you fashion

The attention to detail for good The attention to detail for good promotional practicepromotional practice

The wisdom to know the The wisdom to know the differencedifference

The facts speak for themselves:The facts speak for themselves:Pens and paper, meals and tripsPens and paper, meals and tripsCMECMEConflict of interestConflict of interestPrice controlsPrice controlsFair balanceFair balance

……..and on, and on ..and on, and on

Good Promotional Practices are the Good Promotional Practices are the solution!solution!

The wisdom to know the difference: an The wisdom to know the difference: an aviation parallelaviation parallel

Digital fuel gaugeDigital fuel gauge

Backup digital fuel Backup digital fuel gaugegauge

Analog fuel gaugeAnalog fuel gauge

Backup analog fuel Backup analog fuel gaugegauge

On-board computerOn-board computer

Look in the tanks!!Look in the tanks!!

Four actionable strategiesFour actionable strategies

1.1. Turning your sales reps into Turning your sales reps into information concierges;information concierges;

2.2. Use of content management systems;Use of content management systems;

3.3. Good Promotional Practices ;Good Promotional Practices ;

4.4. Form & support product information Form & support product information exchangesexchanges

1. Transform your sales reps into 1. Transform your sales reps into information conciergeinformation concierge

There when you want themThere when you want themSituation-appropriate & compliant materialSituation-appropriate & compliant materialMake things happenMake things happenNo lies, no alibisNo lies, no alibisWho are your reps talking to?Who are your reps talking to?

Not your father’s doctor…Not your father’s doctor…

More are femaleMore are female

180,000 are FMG’s (1/4) and growing180,000 are FMG’s (1/4) and growing

Increasing debt on graduation Increasing debt on graduation

Average first year income (age 33) is Average first year income (age 33) is $120K, but……. $120K, but…….

Golf?Golf?

Secretarial assistance?Secretarial assistance?

Fancy lifestyle?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 behaviorRep behavior

Best use of time?Best use of time?What defines prescribing habits?What defines prescribing habits?Who Who specificallyspecifically is your target audience? is your target audience?What do your reps know about the medical What do your reps know about the medical literature?literature?What do the doctors know?What do the doctors know?

Target audienceTarget audienceDevices vs pharma? Devices vs pharma?

DNA with PAPDNA with PAP

Typical pharma adTypical pharma ad

Personalize your material Personalize your material and presentationand presentation

Good reprint practicesGood reprint practices

What do your reps know?What do your reps know?Medical literature how to Medical literature how to read and useread and useThe content of the The content of the literature is complexliterature is complexThe The structurestructure of medical of medical literature is becoming literature is becoming more complexmore complexYour reps time with Your reps time with doctors is ever more doctors is ever more valuablevaluableThe rules are changing…The rules are changing………..the more they ..the more they understand, the more understand, the more confident they will be in confident they will be in your job. your job.

How do physicians read the How do physicians read the medical literature? medical literature?

OsmosisOsmosis

Scan titles, names, Scan titles, names, institutionsinstitutions

Read abstractsRead abstracts

Compass roseCompass rose

..

Data in abstracts of published Data in abstracts of published research articles 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 Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised gravitational challenge: systematic review of randomised

controlled trials controlled trials SmithSmith GCSGCS, , Jill P Pell JPJill P Pell JP BMJ 2003; 327:1459 - 1461BMJ 2003; 327:1459 - 1461

ObjectivesObjectives To determine whether parachutes are effective To determine whether parachutes are effective in preventing major trauma related to gravitational in preventing major trauma related to gravitational challenge. challenge.

DesignDesign Systematic review of randomised controlled trials. Systematic review of randomised controlled trials. Data sources:Data sources: Medline, Web of Science, Embase, Medline, Web of Science, Embase,

Cochrane Library databases; appropriate websites & Cochrane Library databases; appropriate websites & citation lists. citation lists.

Study selection:Study selection: Studies showing the effects of using a Studies showing the effects of using a parachute during free fall. parachute during free fall.

Main outcome measureMain outcome measure Death or major trauma, defined as Death or major trauma, defined as an injury severity score > 15. an injury severity score > 15.

ResultsResults We were unable to identify any randomised We were unable to identify any randomised controlled trials of parachute intervention. controlled trials of parachute intervention.

ConclusionsConclusions As with many interventions intended to As with many interventions intended to prevent ill health, the effectiveness of parachutes has not prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation of randomised been subjected to rigorous evaluation of randomised controlled trials. Advocates of evidence based medicine controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by have criticised the adoption of interventions evaluated by using only observational data. Everyone might benefit if the using only observational data. Everyone might benefit if the most radical protagonists of evidence based medicine most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.placebo controlled, crossover trial of the parachute.

Solutions:Solutions:

Publication & presentation strategy – think it Publication & presentation strategy – think it through. through. CurealldiseaseallolCurealldiseaseallol – plan, plan, – plan, plan, plan some more. And planning does not plan some more. And planning does not stop with launch….stop with launch….

Train reps how to read & use the literature Train reps how to read & use the literature to suit yours and doctor’s needsto suit yours and doctor’s needs

Internal journal clubInternal journal club

Challenge conventional wisdom on reprintsChallenge conventional wisdom on reprints

Four actionable strategiesFour actionable strategies

1.1. Turning your sales reps into information Turning your sales reps into information concierges;concierges;

2.2. Use of content management systems;Use of content management systems;

3.3. Good Promotional Practices;Good Promotional Practices;

4.4. Form & support product information Form & support product information exchangesexchanges

2. Use content management systems2. Use content management systems

A day in the life of a doctorA day in the life of a doctor

The round fileThe round file

Compliance rules are complex and getting Compliance rules are complex and getting more somore so

International standards – highest should International standards – highest should applyapply

Belt and braces – use everything that Belt and braces – use everything that might helpmight help

Data acquisition for regulatory approval Data acquisition for regulatory approval insufficient for payor approval. EBM is the order of insufficient for payor approval. EBM is the order of the daythe day

Where you do your studies: best marketsWhere you do your studies: best markets

Who does your studies – it really does matter who Who does your studies – it really does matter who you know …. and who they know!you know …. and who they know!

Where and when you publish/present. And follow Where and when you publish/present. And follow – on publications– on publications

Look at NICE, HTA, iTAPPLook at NICE, HTA, iTAPP

Strategies: DataStrategies: Data

Rep supportRep support

Getting in the door is step 1Getting in the door is step 1

Before (database assets)Before (database assets)

During (presentation assets)During (presentation assets)

After (permission-based marketing, GPP)After (permission-based marketing, GPP)

Buy off on GPP? Buy off on Rep v2.0. This Buy off on GPP? Buy off on Rep v2.0. This truth is self-evident! truth is self-evident!

Four actionable strategiesFour actionable strategies

1.1. Turning your sales reps into information Turning your sales reps into information concierges;concierges;

2.2. Use of content management systems;Use of content management systems;

3.3. Good Promotional Practices;Good Promotional Practices;

4.4. Form & support product information Form & support product information exchangesexchanges

3. Good Promotional Practices3. Good Promotional Practices

““

Where has all the trust gone?” Where has all the trust gone?” ““Where have all the Where have all the ethicsethics gone?”gone?”This new world of compliance This new world of compliance presents you with presents you with opportunities as well as opportunities as well as threatsthreatsIf you engage with GPP now, If you engage with GPP now, you help define the space. you help define the space. The “flexible” marketing The “flexible” marketing budgetbudgetJollying along repsJollying along reps““I didn’t know…..” I didn’t know…..” Don’t be silent, speak upDon’t be silent, speak up

Other actions?Other actions?

Check out Check out www.goodpromotionalpractices.com

No, on second thoughts, No, on second thoughts, contribute contribute to to www.goodpromotionalpractices.com

Four actionable strategiesFour actionable strategies

1.1. Turning your sales reps into information Turning your sales reps into information concierges;concierges;

2.2. Use of content management systems;Use of content management systems;

3.3. Good Promotional Practices;Good Promotional Practices;

4.4. Form & support product information Form & support product information exchangesexchanges

4. Form & support initiatives to bridge 4. Form & support initiatives to bridge the information gapthe information gap

““Consortium” Mark Consortium” Mark HandforstHandforst

Journal ads? DTC TV Journal ads? DTC TV ads?ads?We know about CME, We know about CME, what about UME, GME?what about UME, GME?Own media landscape?Own media landscape?Episodic bombardment? Episodic bombardment? No, become the trusted No, become the trusted purveyor, the concierge purveyor, the concierge motivated by good motivated by good promotional practicespromotional practices

Ethics & good promotional Ethics & good promotional practicespractices

I have heard it said that human beings are I have heard it said that human beings are inherently corrupt so sadly you need inherently corrupt so sadly you need systems to remind and prevent them from systems to remind and prevent them from doing wrong. It is you who will pay the doing wrong. It is you who will pay the fines/settlements. Or go to prison.fines/settlements. Or go to prison.

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

Primum non nocerePrimum non nocere

Maybe Good Promotional Practices could Maybe Good Promotional Practices could become the Declaration of Geneva or become the Declaration of Geneva or Hippocratic oath for healthcare marketing?Hippocratic oath for healthcare marketing?

Pharmaceutical industryPharmaceutical industry

Employs: over 600,000 people and supports 3mEmploys: over 600,000 people and supports 3m

Advances science & invests: > $60B Advances science & invests: > $60B

Contributes to tax base & exports: $23B NJ Contributes to tax base & exports: $23B NJ alonealone

Saves lives…..mine included, so thank you.Saves lives…..mine included, so thank you.

Lets stop apologizing for our industry and proudly Lets stop apologizing for our industry and proudly proclaim our value….while dealing swiftly and proclaim our value….while dealing swiftly and transparently with miscreantstransparently with miscreants

““Do the right thing”Do the right thing”““Everything is for the Everything is for the patient”patient”““Ready, fire, aim!”Ready, fire, aim!”

Good Promotional Practices: The Good Promotional Practices: The culture of intentculture of intent

The times they are a’changinThe times they are a’changinCompliance is an opportunity as well as a Compliance is an opportunity as well as a threatthreatWhen the going gets tough, the tough go When the going gets tough, the tough go shoppingshoppingAccept that the medical landscape is Accept that the medical landscape is changing and stay ahead of the curvechanging and stay ahead of the curveGood Promotional Practices are not only the Good Promotional Practices are not only the wise thing to do, they are the right thing to do!wise thing to do, they are the right thing to do!

The world according to Rush (not The world according to Rush (not Limbaugh)…Limbaugh)…

You can choose a ready You can choose a ready guide in some celestial guide in some celestial voice. voice. If you choose not to If you choose not to decide, you still have decide, you still have made a choice. made a choice. You can choose from You can choose from phantom fears and phantom fears and kindness that can kill; kindness that can kill; I will choose a path that's I will choose a path that's clear- clear- I will choose Free Will. I will choose Free Will.

Thank youThank you

Jonathan M. SackierJonathan M. Sackier

jonathan@pshcconsulting.com

P: (434) 245 8801P: (434) 245 8801

F: (434) 245 8804F: (434) 245 8804

C: (434) 566 3061C: (434) 566 3061