1.
Different hats, same needs:Marketing compliance fromdoctor’s office to boardroom Jonathan M. Sackier May 4, 2011 2011 Pharma Marketing Summit

2.
“Nothing political is correct”

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 todayUnderstand why Good PromotionalPractices serve all constituencies and….

5.
StructureEstablish my bona fides and viewpointWhat do I, representing differentconstituencies, 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

9.
Entrepreneurial recidivist

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 dirtyI come at this from several perspectivesLay of the landFour solutions:Turning your sales reps into informationconcierges;Use of content management systems;Good Promotional Practices ;Form & support product information exchanges

13.
Lay of the landWhat do doctors want?What do companies want?What do directors want?

14.
What do doctors want?Reliable, digestible information delivered in asensitive, timely & efficient mannerMake their patients happyTreated with respectPartnership with integrityBalance the booksGet some time backAvoid aggravation

15.
What do companies want?Sales to……generate profits…….to create jobs, reward investors andfund future productsNew 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 rewardsAvoid aggravation….

17.
So given these alignments, why……is there so much aggravation?

18.
“God, grant me the serenity toaccept the things I cannotchange, the courage to changethe things I can and the wisdomto know the difference.”(Reinhold Niebuhr)

19.
The things I cannot change (probably)Patent lifeNew blockbustercompoundDoctor’s working dayThe competitionHuman behaviorThe regulations

20.
The things I can change (possibly)Conflict of interest & Good PromotionalPractices debateHow physicians view your companyHow you present yourself to physiciansWhat you present to physiciansThe relationships you fashionThe attention to detail for goodpromotional practice

21.
The wisdom to know the differenceThe facts speak for themselves: Pens and paper, meals and trips CME Conflict of interest Price controls Fair balance…..and on, and onGood Promotional Practices are thesolution!

22.
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!!

23.
Four actionable strategiesTurning your sales reps intoinformation concierges;Use of content management systems;Good Promotional Practices ;Form & support product informationexchanges

24.
1. Transform your sales reps into information conciergeThere when you want themSituation-appropriate & compliant materialMake things happenNo lies, no alibisWho are your reps talking to?

25.
Not your father’s doctor…More are female180,000 are FMG’s (1/4) and growingIncreasing debt on graduationAverage first year income (age 33) is$120K, but…….Golf?Secretarial assistance?Fancy lifestyle?

26.
“I feel like the frog in the pan. The temperature on the stove hasbeen turned up degree by degree. And being the over-achiever Iam, I have accommodated to each escalation to the point oflooking around to see the water boiling all around me. Thedemands for menial record-keeping mandates keeping me fromwhat I am better qualified and prepared to do, and the gate-keeping milieu has clipped my capacity to soar to where I havehad adequate flight training!”

27.
Rep behaviorBest use of time?What defines prescribing habits?Who specifically is your target audience?What do your reps know about themedical literature?What do the doctors know?

28.
Target audienceDevices vs pharma?DNA with PAPTypical pharma adPersonalize your materialand presentationGood reprint practices

29.
What do your reps know?Medical literature how toread and useThe content of theliterature is complexThe structure of medicalliterature is becomingmore complexYour reps time withdoctors is ever morevaluableThe rules are changing……..the more theyunderstand, the moreconfident they will be inyour job.

30.
How do physicians read the medical literature?OsmosisScan titles, names,institutionsRead abstractsCompass rose

31.
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 significantdegree (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 "44consecutive 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

32.
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 - 1461Objectives To determine whether parachutes areeffective in preventing major trauma related togravitational challenge. Design Systematic review of randomised controlledtrials.Data sources: Medline, Web of Science, Embase,Cochrane Library databases; appropriate websites &citation lists.Study selection: Studies showing the effects of using aparachute during free fall.Main outcome measure Death or major trauma, definedas an injury severity score > 15.Results We were unable to identify any randomisedcontrolled trials of parachute intervention.Conclusions As with many interventions intended toprevent ill health, the effectiveness of parachutes has notbeen subjected to rigorous evaluation of randomisedcontrolled trials. Advocates of evidence based medicinehave criticised the adoption of interventions evaluated byusing only observational data. Everyone might benefit ifthe most radical protagonists of evidence based medicineorganised and participated in a double blind, randomised,placebo controlled, crossover trial of the parachute.

33.
Solutions:Publication & presentation strategy – thinkit through. Curealldiseaseallol – plan, plan,plan some more. And planning does notstop with launch….Train reps how to read & use the literatureto suit yours and doctor’s needsInternal journal clubChallenge conventional wisdom onreprints

34.
Four actionable strategiesTurning your sales reps into informationconcierges;Use of content management systems;Good Promotional Practices;Form & support product informationexchanges

35.
2. Use content management systemsA day in the life of a doctorThe round fileCompliance rules are complex and gettingmore soInternational standards – highest shouldapplyBelt and braces – use everything thatmight help

36.
Strategies: DataData acquisition for regulatory approvalinsufficient for payor approval. EBM is the order ofthe dayWhere you do your studies: best marketsWho does your studies – it really does matter whoyou know …. and who they know!Where and when you publish/present. And follow– on publicationsLook at NICE, HTA, iTAPP

37.
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!

38.
Four actionable strategiesTurning your sales reps into informationconcierges;Use of content management systems;Good Promotional Practices;Form & support product informationexchanges

39.
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

40.
Other actions?Check outwww.goodpromotionalpractices.comNo, on second thoughts, contribute towww.goodpromotionalpractices.com

41.
Four actionable strategiesTurning your sales reps into informationconcierges;Use of content management systems;Good Promotional Practices;Form & support product informationexchanges

42.
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” MarkHandforst

43.
Ethics & good promotional practicesI 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.

44.
Primum non nocereMaybe Good Promotional Practices could become the Declaration of Geneva or Hippocratic oath for healthcare marketing?

45.
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

46.
“Do the right thing”“Everything is for thepatient”“Ready, fire, aim!”

47.
Good Promotional Practices: The culture of intentThe times they are a’changinCompliance is an opportunity as well as athreatWhen the going gets tough, the tough goshoppingAccept that the medical landscape ischanging and stay ahead of the curveGood Promotional Practices are not only thewise thing to do, they are the right thing to do!

48.
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 thats clear- I will choose Free Will.

49.
Thank youJonathan M. Sackierjonathan@pshcconsulting.comP: (434) 245 8801F: (434) 245 8804C: (434) 566 3061