Pharma Lurking in Social Media

1. BIG PHARMALURKINGIN SOCIALMEDIAWednesday, April 20, 2011

2. Presented atMass Torts Made PerfectApril 14 & 15, 2011Wynn LasVegas, NevadaByGabriel F. Zambranowww.RecallAttorneys.comhttp://www.linkedin.com/in/gabrielfzambranoWednesday, April 20, 2011

3. Introduction ToLurking•Merriam Webster’s Definition:•to lie in wait in a place ofconcealment esp. for an evil intent•to be concealed but capable of beingdiscovered•to constitute a latent threatWednesday, April 20, 2011

4. Frontier Like Conditions010101010101010101010101010011010341234803298492309482094823730948723498723084972134623987462398746237846283462387462387462873642837648273642387641010101001010111101010110101000100234234234234232430100100101001010101110923428340219842310101010101010101010100010010101010101001010101010101010101010100101010101083423429342343423423426785657422990909746426264262464226421001Circa 2011Wednesday, April 20, 2011

5. Web 1.0•Static•Search Driven•Google/YahooDominated•Slow•Dial Up & WaitWednesday, April 20, 2011

6. Web 2.0•Engaging•Fast•No longerpure search•Video•Blogs•InteractingWednesday, April 20, 2011

7. Tobacco & Pharma•Masters of Deception & PublicRelation Campaigns•History Repeats Itself•Predatory Behavior•Contemporary Media and Mediums•TV, Print, Radio, .www, Blogs/Bloggers, SM, Apps, SMS, MMS•.www used as ‘Web of Entrapment’via digital buzz techniques•Targeting of GenerationsWednesday, April 20, 2011

8. Tobacco & Pharma•Major PR Campaigns•“Total Coverage” through bombardmentand digital access•TV,Radio,.www,MMS,SMS,Digital Media•Celebrity Endorsements•Generation gaps being filled andexploited in every medium to reachand penetrate markets for BlockbusterresultsWednesday, April 20, 2011

9. Citizens Commission onHuman RightsWednesday, April 20, 2011

10. Allan M. BrandtThe Cigarette CenturyWednesday, April 20, 2011

11. Suspend YourDisbelief.We are surroundedby their DIGITALMATRIX.........Wednesday, April 20, 2011

12. What is Social Media?• Social Media (“SM”)• Facebook• YouTube• Twitter - 140 Character Micro-Blog• Blogs/Bloggers• LinkedIn (100 Million users/IPO 2011)Wednesday, April 20, 2011

13. World Wide Web• Paradigm Shifts Continue• .www• .com• .net• .org• .info• .co (Summer 2010)Wednesday, April 20, 2011

14. Villages & Communities• Small interconnected like minded people across theweb with mobile access• Cloud Based for Everyone• Cross Platform Accessibility• PC• MAC• iPhone• Blackberry• AndroidWednesday, April 20, 2011

15. Applications (“Apps”)• Access from Mobile Devices• Downloaded• iTunes• Blackberry• Droid• Send & Receive InformationWednesday, April 20, 2011

16. Cultural Norm• “There is an App for that”• Open Door to interaction with Pharmaproduct or reliance on ‘their’ message• Part of Consumer Experience andEnvironment• Pharma Converting Net Gen Consumer• Expectation and Customization• M.D.’s in training/residency are targets forbrand awareness, becoming advocates orKey Opinion Leaders (KOL)Wednesday, April 20, 2011

17. Social Media:Land Ruled byThe AvatarGraphical representation of user or alter ego.Not J. Cameron’s Avatar Nation.Wednesday, April 20, 2011

18. Pollination of Generations• Baby Boomer Generation (1946-1964)• Generation X (1965-1976)• Baby Bust• The Net Generation (1977-1997)• GenerationY or The Millenials• Generation Next (1998-Present)Grown Up Digital by Dan TapscottWednesday, April 20, 2011

19. Where is the FDA• FDA Guidance on SM• Repeatedly Delayed• Arguments on Delay• Media Changing Too Fast• Need Perceived as Limited• Resources Already at Limit• Signiﬁcance Discounted• FDA utilizing and ﬁnding ‘Voice’Wednesday, April 20, 2011

20. FDA is Evolving• FDA utilizing and ﬁnding “Voice”• Invited comments• Streamlining itself in recent years to“act” faster• Has actually embraced and is usingSocial Media• FDA is plugged into contemporarySocial Media usesWednesday, April 20, 2011

21. FDA Guidance• Read Between the Lines of FDA WarningLetters• Legal Defense Teams for Pharma arereading, analyzing and advising based uponprior, or recent, action in form of Letters• Wild West but• Historical Precedent in Ghosts ofYearsPast• Read the OmensWednesday, April 20, 2011

22. Big Brother is Watching• There were hearings and contributions• FDA Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet &Social Media Tools, 74 Fed. Reg. 48, 083, 48, 085(September 21, 2009)• Internet on the Radar in mid 1990’s• Notice of Public Meeting, 61 Fed. Reg. 48,707(September 16, 1996)Wednesday, April 20, 2011

23. 2010 In Review• A Letter re use of Facebook platform• 8 PromotionalVideos Content & Format• 13 .www, webcasts, or webbased video, e-mail, SM• “Oral Statements” drew FDA Ire 2x fromconference based statementsWednesday, April 20, 2011

24. Facebook Phenomena• The Accidental Billionaires -The Founding ofFacebook:A Tale of Sex, Money, Genius & Betrayalby Benz Mezrich• Did you overlook what Facebook became?• 500 Million Users and growing• Same idea with Pharma, Apps & SM• Except they have been exploiting andincorporating into campaigns for years now• Litigators must remain vigilant and watchful oftheir uses of Social MediaWednesday, April 20, 2011

25. AstraZenecaFilling theVoid - Exploiting theMatrix of OpportunityWednesday, April 20, 2011

26. Multiple Portals & Rabbit Holes -A Message for Every NationWednesday, April 20, 2011

27. Wednesday, April 20, 2011

28. Sales Representatives are Still Central to Messagingto Learned Intermediary3/30/11Survey8 of 10“usefulsources”Wednesday, April 20, 2011

29. Messaging The Consumer in CyberspaceWednesday, April 20, 2011

32. Thought Leadersvs.OpportunistSelf PolicingProphecy12/1/10Wednesday, April 20, 2011

37. April 2011www.yaz-us.comWednesday, April 20, 2011

38. ENBREL - Safe Harbor in SMWednesday, April 20, 2011

39. Every Story Needs a HeroWednesday, April 20, 2011

40. Notice the Support for Recouping CostsWednesday, April 20, 2011

42. Omitted to Tell• ENBREL (etanercept)• REMS - Risk Evaluation and Mitigation Strategy• GOOGLE results do not mention REMS either• Actionable or Not ?Wednesday, April 20, 2011

43. YouTube• AstraZeneca efforts continue• BAYER - Tried inYAZ with counseling video• Not everyone comes out a winner using SocialMedia• Failures are public - Charlie Sheen - Twitter• Success becomes viral - Charlie Sheen - Torpedo ofTruth TourWednesday, April 20, 2011

48. TwitterWednesday, April 20, 2011

49. Charlie Kimball INDYCAR SeriesWednesday, April 20, 2011

52. Following0Followers132www.novonoWednesday, April 20, 2011

54. Social Media Triumph:K-V & MAKENA -A 2011Web 2.0 Nightmare forPharmaWednesday, April 20, 2011

63. Apps AvailableFREEWednesday, April 20, 2011

68. NOVARTIS - TASIGNA• Facebook ShareWidget• Efﬁcacyrepresented w/oany risks• Impliedsuperiority• Misbranding• Not submitted toFDA prior to useWednesday, April 20, 2011

69. NOVARTIS - TASIGNA• Indicated fortreatment oftreatment ofchronic phase/acceleratedPhiladelphiachromosomepositive Ph+chronicmyelogenousleukemia (CML) inadult patientsresistant orintolerant to priortherapy thatincluded imatinibWednesday, April 20, 2011

70. Meanwhile Across thePond on 4.1.11Wednesday, April 20, 2011

71. 2011 SM Guidance• Delayed as of March 2011• UK has April 2011• FDA Warning Letters are barometers• Pharma Defense Firms are providingguidance based upon Letters and Action• Self Policing will not work• Government Funding Meltdown will lead toCrisis ManagementWednesday, April 20, 2011

72. Is the FDA Keeping Up?Wednesday, April 20, 2011

73. • Mediums continue to emerge• Viral Potential - Charlie Sheen Phenomena- The Torpedo of Truth• Vigilance in future litigation on uses of SM,Third Party Advocates• Limited Resources in Wide Open Arena• FDA is adopting uses, experimenting,learning, probing and using SM• Proactive FDA skilled in SM emergingWednesday, April 20, 2011

74. FDA in APRIL 2011Pro-Consumer User FriendlyWednesday, April 20, 2011

75. FDA is ADOPTING SMWednesday, April 20, 2011

76. History Repeats Itself•Public Health Message Shouted Down byPharma Dollars•Darwinian Environment•Understaffed - 12, 000 Career Employees•Underfunded•FDA has Evolved and Using Social Media•Morphing of Web 2.0 Technology and usescontinuesWednesday, April 20, 2011

77. •FDA is part of the Presidential Administration notand independent agency like SEC or FTC•All Testimony before Congress is reviewed andapproved by White House Office of Managment& Budget•Pharma PR Machine is capitalizing on ability tocreate, manipulate and change via digital buzz•Plenty of work for FDA and Consumer Advocates•“Personal Choice”•“Customization” by Net Generation•David & Goliath Battles RemainWednesday, April 20, 2011

78. Gabriel F. Zambranowww.RecallAttorneys.co@RecallAttorneysWednesday, April 20, 2011

79. Gabriel F. Zambranowww.GabrielFZambrano.com@gfzambranoWednesday, April 20, 2011

80. Contact InformationGabriel F. Zambranowww.RecallAttorneys.cowww.linkedin.com/in/gabrielfzambranoWednesday, April 20, 2011