Pharma Lurking in Social Media

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

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

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

Frontier Like Conditions
01010101010101010101010101001101034123480329849
230948209482373094872349872308497213
46239874623987462378462834623874623
874628736428376482736423876410101010010
101111010101101010001002342342342342324301001
00101001010101110923428340219842310101010101010
1010101000100101010101010010101010101010101010101001
01010101083423429342343423423426785657
422990909746426264262464226421001
Circa 2011

Web 1.0
•Static
•Search Driven
•Google/Yahoo
Dominated
•Slow
•Dial Up & Wait

Web 2.0
•Engaging
•Fast
•No longer
pure search
•Video
•Blogs
•Interacting

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

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

Citizens Commission on
Human Rights

Allan M. Brandt
The Cigarette Century

Suspend Your
Disbelief.
We are surrounded
by their DIGITAL
MATRIX.........

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

World Wide Web
• Paradigm Shifts Continue
• .www
• .com
• .net
• .org
• .info
• .co (Summer 2010)

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

Applications (“Apps”)
• Access from Mobile Devices
• Downloaded
• iTunes
• Blackberry
• Droid
• Send & Receive Information

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)

Social Media:
Land Ruled by
The Avatar
Graphical representation of user or alter ego.
Not J. Cameron’s Avatar Nation.

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

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’

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

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

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)

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

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

AstraZeneca
Filling theVoid - Exploiting the
Matrix of Opportunity

Multiple Portals & Rabbit Holes -
A Message for Every Nation

Sales Representatives are Still Central to Messaging
to Learned Intermediary
3/30/11
Survey
8 of 10
“useful
sources”

Messaging The Consumer in Cyberspace

Thought Leaders
vs.
Opportunist
Self Policing
Prophecy
12/1/10

April 2011
www.yaz-us.com

ENBREL - Safe Harbor in SM

Every Story Needs a Hero

Notice the Support for Recouping Costs

Omitted to Tell
• ENBREL (etanercept)
• REMS - Risk Evaluation and Mitigation Strategy
• GOOGLE results do not mention REMS either
• Actionable or Not ?

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

Twitter

Charlie Kimball INDYCAR Series

Following
0
Followers
132
www.novo
no

Social Media Triumph:
K-V & MAKENA -
A 2011
Web 2.0 Nightmare for
Pharma

Apps Available
FREE

NOVARTIS - TASIGNA
• Facebook Share
Widget
• Efﬁcacy
represented w/o
any risks
• Implied
superiority
• Misbranding
• Not submitted to
FDA prior to use

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

Meanwhile Across the
Pond on 4.1.11

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

Is the FDA Keeping Up?

• 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

FDA in APRIL 2011
Pro-Consumer User Friendly

FDA is ADOPTING SM

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

•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

Gabriel F. Zambrano
www.RecallAttorneys.co
@RecallAttorneys

Gabriel F. Zambrano
www.GabrielFZambrano.com
@gfzambrano

Contact Information
Gabriel F. Zambrano
www.RecallAttorneys.co
www.linkedin.com/in/gabrielfzambrano

Pharma Lurking in Social Media

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