Pharma Lurking in Social Media

1. BIG PHARMA LURKING IN SOCIAL MEDIA Wednesday, April 20, 2011

2. Presented at Mass Torts Made Perfect April 14 & 15, 2011 Wynn LasVegas, Nevada By Gabriel F. Zambrano www.RecallAttorneys.com http://www.linkedin.com/in/gabrielfzambrano Wednesday, April 20, 2011

3. Introduction To Lurking •Merriam Webster’s Definition: •to lie in wait in a place of concealment esp. for an evil intent •to be concealed but capable of being discovered •to constitute a latent threat Wednesday, April 20, 2011

4. Frontier Like Conditions 01010101010101010101010101001101034123480329849 230948209482373094872349872308497213 46239874623987462378462834623874623 874628736428376482736423876410101010010 101111010101101010001002342342342342324301001 00101001010101110923428340219842310101010101010 1010101000100101010101010010101010101010101010101001 01010101083423429342343423423426785657 422990909746426264262464226421001 Circa 2011 Wednesday, April 20, 2011

5. Web 1.0 •Static •Search Driven •Google/Yahoo Dominated •Slow •Dial Up & Wait Wednesday, April 20, 2011

6. Web 2.0 •Engaging •Fast •No longer pure search •Video •Blogs •Interacting Wednesday, April 20, 2011

7. Tobacco & Pharma •Masters of Deception & Public Relation 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 Generations Wednesday, April 20, 2011

8. Tobacco & Pharma •Major PR Campaigns •“Total Coverage” through bombardment and digital access •TV,Radio,.www,MMS,SMS,Digital Media •Celebrity Endorsements •Generation gaps being filled and exploited in every medium to reach and penetrate markets for Blockbuster results Wednesday, April 20, 2011

9. Citizens Commission on Human Rights Wednesday, April 20, 2011

10. Allan M. Brandt The Cigarette Century Wednesday, April 20, 2011

11. Suspend Your Disbelief. We are surrounded by their DIGITAL MATRIX......... 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 the web with mobile access • Cloud Based for Everyone • Cross Platform Accessibility • PC • MAC • iPhone • Blackberry • Android Wednesday, April 20, 2011

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

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

17. Social Media: Land Ruled by The Avatar Graphical 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 Tapscott Wednesday, 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 using Social Media • FDA is plugged into contemporary Social Media uses Wednesday, April 20, 2011

21. FDA Guidance • Read Between the Lines of FDA Warning Letters • Legal Defense Teams for Pharma are reading, analyzing and advising based upon prior, or recent, action in form of Letters • Wild West but • Historical Precedent in Ghosts ofYears Past • Read the Omens Wednesday, 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 from conference based statements Wednesday, April 20, 2011

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

25. AstraZeneca Filling theVoid - Exploiting the Matrix of Opportunity Wednesday, April 20, 2011

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

27. Wednesday, April 20, 2011

28. Sales Representatives are Still Central to Messaging to Learned Intermediary 3/30/11 Survey 8 of 10 “useful sources” Wednesday, April 20, 2011

29. Messaging The Consumer in Cyberspace Wednesday, April 20, 2011

32. Thought Leaders vs. Opportunist Self Policing Prophecy 12/1/10 Wednesday, April 20, 2011

37. April 2011 www.yaz-us.com Wednesday, April 20, 2011

38. ENBREL - Safe Harbor in SM Wednesday, April 20, 2011

39. Every Story Needs a Hero Wednesday, April 20, 2011

40. Notice the Support for Recouping Costs Wednesday, 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 Social Media • Failures are public - Charlie Sheen - Twitter • Success becomes viral - Charlie Sheen - Torpedo of Truth Tour Wednesday, April 20, 2011

48. Twitter Wednesday, April 20, 2011

49. Charlie Kimball INDYCAR Series Wednesday, April 20, 2011

52. Following 0 Followers 132 www.novo no Wednesday, April 20, 2011

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

63. Apps Available FREE Wednesday, April 20, 2011

68. NOVARTIS - TASIGNA • Facebook Share Widget • Efﬁcacy represented w/o any risks • Implied superiority • Misbranding • Not submitted to FDA prior to use Wednesday, April 20, 2011

69. NOVARTIS - TASIGNA • Indicated for treatment of treatment of chronic phase/ accelerated Philadelphia chromosome positive Ph+ chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib Wednesday, April 20, 2011

70. Meanwhile Across the Pond on 4.1.11 Wednesday, 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 providing guidance based upon Letters and Action • Self Policing will not work • Government Funding Meltdown will lead to Crisis Management Wednesday, 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 emerging Wednesday, April 20, 2011

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

75. FDA is ADOPTING SM Wednesday, April 20, 2011

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

77. •FDA is part of the Presidential Administration not and independent agency like SEC or FTC •All Testimony before Congress is reviewed and approved by White House Office of Managment & Budget •Pharma PR Machine is capitalizing on ability to create, manipulate and change via digital buzz •Plenty of work for FDA and Consumer Advocates •“Personal Choice” •“Customization” by Net Generation •David & Goliath Battles Remain Wednesday, April 20, 2011

78. Gabriel F. Zambrano www.RecallAttorneys.co @RecallAttorneys Wednesday, April 20, 2011

79. Gabriel F. Zambrano www.GabrielFZambrano.com @gfzambrano Wednesday, April 20, 2011

80. Contact Information Gabriel F. Zambrano www.RecallAttorneys.co www.linkedin.com/in/gabrielfzambrano Wednesday, April 20, 2011

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Pharma Lurking in Social Media

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