Social Media and the Future of Adverse Event Reporting
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This is the presentation I will make at the Drug Safety Congress on Thurs, April 22, 2010: http://bit.ly/9Bmo5M

This is the presentation I will make at the Drug Safety Congress on Thurs, April 22, 2010: http://bit.ly/9Bmo5M

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Social Media and the Future of Adverse Event Reporting Presentation Transcript

  • 1. Social
Media
and
the
Future
of Adverse
Event
Repor8ng John Mack Publisher, Pharma marketing News & Pharma Marketing Blog @pharmaguy on Twitter johnmack@virsci.com
  • 2. 2 Agenda  Pharma’s
current
use
of
social
media Who
are
the
leaders? Need
for
FDA
guidelines  Solving
the
adverse
event
problem The
AE
red
herring Whose
problem
is
it
anyway? Social
media
is
the
solu8on,
not
the
problem  Conclusion
  • 3. 3 Pharma’s
Use
of
Social
Media*  Pharma
and
Healthcare
Social
Media
Wiki 55
TwiNer
Accounts
(excluding
personal
pharma
ppl) 45
Facebook
Sites 35
YouTube
Sites 31
Brand‐Sponsored
Pa8ent
Communi8es 19
Blogs You are not likely to find any adverse events mentioned on any of these sites, except perhaps for sponsored communities. Most have comments turned off or review comments before they are posted. *Not all are specifically sites owned and operated by FDA-regulated companies.
  • 4. 4 Dosie
Awards
Finalists TwiNer
Accounts AF
Stat
(sanofi‐aven8s) JNJComm
(J&J’s
Marc
Monseau) Race
with
Insulin
(Novo
Nordisk) Roche Xpresskindness
(Allergan) Most pharma Twitter accounts are focused on company news. Recently, however, non-branded campaigns focused on disease- awareness or cause marketing have been launched.
  • 5. We’re
S8ll
Friends I called this tweet “Sleazy Twitter Spam”
  • 6. 7 Dosie
Awards
Finalists Best
Brand‐Sponsored
Pa8ent
Communi8es Accu‐Check
Diabetes
Link
(Roche) Children
with
Diabetes
(J&J
Lifescan) Diabetes
Handprint
(J&J
Lifescan) Crohn’s
and
Me
(UCB) Voices
of
Diabetes
(Novo
Nordisk)
  • 7. “Real Stories” on some sites may be authentic, but not user-generated content, which is the hallmark of social media.
  • 8. 9 Dosie
Awards
Finalists Pharma
YouTube
Channels Goinsulin
(sanofi‐aven8s) Johnson
&
Johnson
Health
Channel Pfizer
Europe Pfizer
UK
(the
rat
video!) Most pharma YouTube channels are disease information sites. Some have patient story videos that have been professionally produced, not user-generated. Most channels have comments turned off.
  • 9. 10 Dosie
Awards
Finalists Pharma
Blogs More
Than
Medicine
(GSK) JNJBTW
(J&J) Think
Science
Now
(Pfizer) AZ
HealthConnec8ons There are very few pharma blogs. A couple of disease or product- related blogs have gone defunct after the person responsible has left the company (eg, Centocor 411, alli blog). Those that are left mainly focus on corporate news and views. You won’t find any AEs here.
  • 10. 11 Dosie
Awards
Finalists Facebook
Pages Changing
Possibili8es
in
Hemophilia
(novo
nordisk) The
Coali8on
to
Prevent
Deep
Vein
Thrombosis (snaofi‐aven8s) Gardasil
(GSK) Johnson
&
Johnson VOICES
(sanofi‐aven8s)
  • 11. S‐A’s
VOICES:
First
Case of
“AE”
Mishandling This is what happens when you don’t implement a policy for handling user-generated content.
  • 12. 13 AERs
&
Regula8on
of
Pharma
Social
Media  FDA
Public
Hearing  AE
Repor8ng
Requirements
a
Major
Concern PMN
Survey
Results Industry
Comments
to
FDA  Is
It
a
Red
Herring? Nielsen
Data Pa8entsLikeMe
Data TwiNer
Study
  • 13. 14 FDA
Public
Hearing/Docket  14
NOV
LeNers
Regarding
Paid
Search
Engine
Ads
Issued March,
2009
Leads
to
Call
for
Public
Hearing/Guidance  Part
15
Hearing
held
Nov
13
‐
13,
2009:
“Promo8on
of
Food and
Drug
Administra8on‐Regulated
Medical
Products
Using the
Internet
and
Social
Media
Tools”  Docket
No.
FDA‐2009‐N‐0441
open
for
comments
through February
28,
2010  Drao
Guidance
Expected
by
End
of
2010
  • 14. 15 Issues Accountability Fulfilling
Regulatory
Requirements Pos8ng
Correc8ve
Informa8on Links Adverse
Event
Repor8ng  What
Techniques
are
Used
by
Pharma
to
Monitor
Adverse
Events on
Social
Media
Sites?  How
is
Adverse
Event
Informa8on
from
Social
Media
Sources Processed
by
Pharmacos?  Challenges
Handling
Adverse
Events
Found
on
SM
Sites  Uncertain8es
Regarding
Repor8ng
Adverse
Events
Found
on
Social Media
Sites
  • 15. 16 Pharma
Marke8ng
News
Survey
Overview  Online
from
9/20/2009
through
2/25/2010  Included
All
19
ques8ons
from
FDA 
Tallied
votes
on
specific
answers/solu8ons 
Plus
comments  SubmiNed
Results
to
Docket 
274
Respondents 
731

comments
  • 16. 17 Social
Media
AE
Uncertain8es Adverse Event Reporting What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?  Uncertainty
regarding
the
true iden8ty
of
the
reporter
(anonymous source)  Uncertainty
regarding
the
true iden8ty
of
the
pa8ent
(no
pa8ent named)  Uncertainty
regarding
the
iden8ty
of the
drug
(eg,
reporter
refers
to "sleep
pill"
rather
than
brand
name of
drug)  Uncertainty
regarding
the seriousness
of
the
event
reported
  • 17. 18 Social
Media
AE
Challenges Adverse Event Reporting What challenges are presented in handling adverse event information from these sources?  The
amount
of
informa8on
from these
sources
is
poten8ally
too
vast to
be
processed
economically
(lack of
resources)  Finding
adverse
event
informa8on from
these
sources
is
like
finding
a needle
in
a
haystack
(too
daun8ng)  The
informa8on
is
usually incomplete
and
does
not
meet
the requirements
for
submirng
a meaningful
AER
(not
ac8onable)  There
are
many
poten8al
issues
that won't
fully
be
known
un8l
the prac8ce
of
monitoring
social
media for
AEs
is
more
prevalent
(unknown issues)
  • 18. 19 Industry
Comments
re:
Privacy
Issues  PhRMA
raised
privacy
issue:
FDA
should
not
force
manufacturers
to seek
personal
health
informa8on
from
pa8ents
or
reporters
in
a public
forum  Lilly
also
cited
privacy
issues
and
said
“Na8onal
and
interna8onal privacy
laws
…may
preclude
sponsors
from
aNemp8ng
to
obtain follow‐up
informa8on…
any
aNempts
to
request
personal informa8on
create
significant
mistrust
in
any
company
or
other en8ty
aNemp8ng
to
obtain
that
informa8on”
  • 19. 20 Industry
Comments  Novar8s
suggested
that
FDA
redefine
“iden8fiable
reporter”
as “privately
contactable”
(e‐mail
address
w/o
name,
phone
number
is not
suitable)  AstraZeneca
suggested
e‐mail
address
or
Facebook
contact
alone
is suitable  J&J
proposed
that
the
technology
of
the
Internet
be
used
to
assist
in rou8ng
poten8al
adverse
events
to
the
FDA  AbboN

suggested
FDA
make
available
a
user‐friendly
system through
which
web
users
can
report
events
directly
to
FDA

as
was suggested
by
speakers
at
the
public
hearing
  • 20. 21 AE
Repor8ng
Widget “One‐Click”
Access
to
FDA
and/or
Pharmaco
AE
Repor=ng
System Pharmaceu8cal
companies
could
post
FDA
approved
widgets
on
their
drug.com
Web
and
social
networking
sites.
  • 21. Problems
with
MedWatch  Garbage
In,
Garbage
Out Unknown
to
many
pa8ents Complicated
form Fails
to
capture
important
AEs Doctors
“downgrade
symptoms”
and
fail
to
document
AEs
in
fear of
being
sued Passive
vs.
Ac8ve
System Social media tools and networks may help overcome some of these problems. First, let’s see what pharma companies are doing to handle AEs on how frequently AEs are encountered on social networks.
  • 22. 23 Monitoring
&
Processing
AEs  In
terms
of
processing
AEs
on
company‐owned
social
media
sites,
Sanofi‐ Aven8s
recommends
the
following
monitoring
"parameters:" 1. Development
of
search
terms
(product/disease
specific)
and
8meframes 2. Development
of
process
for
iden8fying
and
transferring
poten8al adverse
events
to
the
company's
Pharmacovigilance
department 3. Training
monitoring
staff
(in‐house
and/or
vendor)
on
the aforemen8oned
process 4. Training
vendors
on
company
standard
opera8ng
procedures
(SOPs)
for adverse
event
repor8ng 5. Internal/vendor
audits
to
assess
compliance How many pharma companies have such parameters in place in not known. 46% of pharma respondents to the PMN Survey did not know or said their companies had no SOPs.
  • 23. Are
J&J
Agents
Trolling
for
Adverse Events
on
the
Internet? I am a member of BzzAgent, an online networking site that offers free trials or products to people as a means of marketing. I just took a survey through BzzAgent for Johnson & Johnson, which basically was more of a "contract" where if chosen, I agreed to notify J&J if I became aware of any negative talk about their products. It was all couched in terminology implying that I would only be doing this as a representative of J&J, and only because it was "required by law" for all J&J employees to report any and all "adverse events" associated with use of J&J products. It mentioned that I would be under obligation to report anything I heard, even if on the internet, including contact information for the person stating the problem. Nothing about getting their permission to relay that information, which stuck out given the detailed, "legal” approach of the survey. So, basically - agreeing to be a "troll" You cannot expect a consumer hired by BzzAgent to know if all the requirements for reportable AEs are met. Therefore, J&J is asking these consumers to scoop up and report everything, which makes it necessary for J&J to sift through these "trolled" reports to find any that meet the requirements for reporting to the FDA. No wonder many pharmacos find this too daunting a task and give up on getting involved in social media.
  • 24. 25 AEs
Found
on
Social
Media
Sites  BuzzMetrics/Nielsen
Study  It
was
feared
that
spontaneous
consumer
feedback
might
contain high
rates
of
AEs
as
consumers
candidly,
and
some8mes anonymously,
share
their
experiences
online  An
analysis
of
500
healthcare‐related
messages
posted
online across
mul8ple
disease
categories
found
only
one
message
that incorporated
the
informa8on
needed
to
meet
all
four
of
the
FDA’s AE
repor8ng
requirements Mostly because comments were anonymous. No attempt made to identify reporter.
  • 25. 26 AEs
Found
on
TwiNer  “Dissemina8on
of
health
informa8on
through
social networks:
TwiNer
&
an8bio8cs  971
TwiNer
status
updates
(“tweets”)
that
men8oned
“an8bio8c”
or “an8bio8cs”
were
analyzed  113
(12%)
were
categorized
as
“side
effects/nega8ve
reac8ons”  Authors
say
that
social
networks
can
“poten8ally
be
used
to
gather real‐8me
health
data”
  • 26. 27 Pa8entsLikeMe  An
online
community
of
pa8ents
(registered
users)  Randomly
selected
500
forum
posts
from
among
364,000
in
2009  7%
(35)
of
these
incorporated
all
four
elements
necessary
for reportable
AEs  “Given
our
current
membership
of
approximately
55,000
pa8ents represen8ng
only
15
diseases
among
hundreds
that
we
plan
to
build, the
contribu8on
to
drug
safety
and
public
health
could
be
substan8al.”  if
pa8ents
were
given
the
right
tools
that
facilitate
access
to
their personal
medical
data,
the
8me
required
to
report
an
AE
to
the
FDA could
be
reduced
by
as
much
as
44%
(from
36
minutes
down
to
20 minutes).
  • 27. UCB‐Sponsored
PLM
Epilepsy
Community  Goal:
Generate
pa8ent‐reported
outcomes
that
may
help
UCB
beNer understand
how
pa8ents
live
with
epilepsy
and
help
advance epilepsy
care.  Provides
disease
tracking
tools  Deployed
a
system
for
repor8ng
adverse
events
to
FDA “UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.” -- Peter Verdru, MD, UCB’s Vice President of Clinical Research
  • 28. If
Pa8ents
Know
Best…  Dr.
Ethan
Basch,
Memorial
Sloan‐KeNering
Cancer
Center,
is developing
an
electronic
pa8ent‐reported
system
for
monitoring and
repor8ng
symptoma8c
AEs
that
pa8ents
may
experience
during treatment Expense
to
implement
on
a
large
scale
across
many
different treatments Social
Networks
like
PLM
are
FREE
electronic
systems
that
can
be used
for
capturing
adverse
events Dr.
Basch
might
do
well
to
get
his
survey
out
to
pa8ents
who
are already
self‐organized
around
treatments
on
social
media
sites
  • 29. Reporter
“Noise” PhRMA contends that the “potential value of safety information taken from third party web sites contributing to a benefit-risk assessment of a medicine is likely to be low when compared with other sources of data including randomized controlled trials, observational data and spontaneous data.” This may be another example of the drug industry being out of synch with patients and physicians.
  • 30. 31 Resources  Pharma
Marke8ng
News − Monthly
electronic
newsleNer − 7,300
opt‐in
subscribers − Ninth
consecu8ve
year
of
publica8on − www.news.pharma‐mk8ng.com  Pharma
Marke8ng
Blog – 25,000
visitors
per
month – pharmamk8ng.blogspot.com/  PharmaGuy
TwiNer
Account – 5,600
Followers – TwiNer.com/pharmaguy
  • 31. 32 Contact
Informa8on John Mack Follow me on Twitter: http://twitter.com/pharmaguy Facebook page: http://www.facebook.com/pharmaguy www.news.pharma-mkting.com www.pharmamkting.blogspot.com johnmack@virsci.com 215-504-4164 215-504-5739 (Fax)