This is a webinar version of a talk I originally gave at a DIA event in Wash DC. I've used different examples from my original talk but the theme is the same.
1. Here’s an
example
comment
bubble
Hello and thanks for viewing my presentation. I usually create my
presentations to complement my speaking, and I’m aware they may
not make as much sense to people viewing them without my
discussion.
For this presentation I’ve tried to set the stage by include some
explanatory comments so that when you view this it might make a
little more sense to you.
I did this by including yellow comment bubbles that attempt to give
you some more context. See an example below.
If you have any questions about the presentation or wish to discuss
any of the points, please feel free to contact me.
Thanks!
Michael Ibara
http://www.linkedin.com/in/ibara
2. “All progress depends on the unreasonable man”
Why A Lack of Vision Will Keep Us from Using
Social Media to Improve Safety
Michael A. Ibara
3. DISCLAIMER
Pfizer supports and funded ASTER and continues to
invest in the concepts and goals involved in this work.
During this talk, any opinions, suggestions or crazy
statements are entirely my own.
5. “All progress depends on the unreasonable man”
Why A Lack of Vision Will Keep Us from Using
Social Media to Improve Safety
Michael A. Ibara
I originally
presented
this here
6. “All progress depends on the unreasonable man”
Why A Lack of Vision Will Keep Us from Using
Social Media to Improve Safety
Michael A. Ibara
My first
presentation
used these 4
concepts.
In the webinar I
dumped these
concepts and
went for
something else…
7. “The reasonable man
adapts himself to the
world; the
unreasonable one
persists in trying to
adapt the world to
himself. Therefore all
progress depends on
the unreasonable
man.”
George Bernard Shaw (1856 - 1950), Man and Superman
(1903) "Maxims for Revolutionists"
8. My current views are based on ideas I’ve been working on
since 2006 which lead in 2009 to the “ASTER” study,
demonstrating direct and automated capture of adverse events
directly from an electronic health record.
Since then I’ve seen
the promise of new ideas
in safety realized at a
dramatically slower rate
than ideas in healthcare
at large
9. Enough time has passed since the first
introduction of new ideas based on
social media for anyone (who takes the
time) to see these new concepts
present fundamental challenges to our
current paradigm of safety.
But social media is a symptom, not a
cause, of what's wrong with safety
today.
The digitization of healthcare data combined with the
internet creates scenarios unimaginable 10 years ago.
And yet, we continue to try and shoehorn these new
sources of data and new business models into concepts
that are over 20 years old.
10. If we do not rise to the challenges and
opportunities presented to us by this
epochal change in healthcare,
the current
pharma safety
Industry
will go
down in history
As 'those other guys'.
11. I’m taking the long view here…
There are technology efforts, research projects, and even
recent efforts in the industry that show progress, and
we’re having some success in interpreting current
regulations and applying them
to situations created by
Digitized healthcare
data and social
media…
15. The concepts that make up our current
business model – upon which our
current regulations and practices are
built – do not allow us to take
advantage of the new technologies and
possible working models that exist now
and are evolving every day
16. We can continue to adapt
our practices in the face of
new technologies and
models but ultimately
there is no smooth
evolution from our
current concepts and
model to the future
We are here
We need to
be here
17. So I’m a short-term optimist…
But I’m a long-term pessimist
18. Short-term we can see the
promise of technologies and
even some regulatory efforts…
But long-term we will not
realize the potential of digital
healthcare for safety unless we
make radical changes to our
business model, and therefore
our regulations
20. LDKIT (limited duration key issue team)
Goal: To facilitate FDA guidance on pharmacovigilance
issues in social media
Drafted a Q&A document coordination with Legal FDA
Focus Group which prioritized important issues of
uncertainty around pharmacovigilance for social media
– created a list of questions and proposed answers.
Met with FDA to discuss document.
21. Q: Does the International Conference on Harmonization (ICH)
E2D guidance still apply with respect to the adverse event
screening and reporting requirements of IND sponsors and
NDA/BLA applicants (referred to in this document as
“companies”)?
Q: Under ICH E2D, companies “are not expected to screen
external websites for ADR information. However, if [a company]
becomes aware of an adverse reaction on a website that it does
not control, the [company] should review the adverse reaction
and determine whether it should be reported.” Does the FDA
continue to support the recommendation in the ICH guidance
regarding the responsibility of companies for screening external
websites for potential adverse event information?
Q: Are companies expected to screen web sites and media that
they control to find potential adverse event information?
Example questions…
22. A: Yes, consistent with the ICH standard discussed above, the FDA
does not require companies to review the content and process
safety information on third-party web sites that companies do
not control. FDA understands that it is impossible for companies
to monitor all web sites and social media.
If a company chooses to view non-company sponsored sites, the
viewed pages should be monitored for adverse events for the
period of viewing. For example, if a company project plan
specifies that the company will view user-generated content for
three days, then it is expected that the company will monitor for
adverse events for the duration of the three days.” Companies
should develop policies and procedures under which employees
or agents who encounter potentially reportable safety
information on the Internet while working for the company
would report such information to company pharmacovigilance
staff for analysis.
Example answer…
23. PV Working Subteam
To develop a globally applicable set of recommendations
for standard practices and policies to optimize the value
of, and minimize the risks posed by the information
contained in social media
Develop white paper
Develop real-life scenarios
Meet with FDA
Study…?
24. Work underway now…
Survey of current regulations related to social media
Excellent suggestions, solutions
Meetings, etc. TBD
25.
26. In spite of our best efforts and the
reassuring guidance from certain
groups, we don’t know
how to take advantage
of the models that are
emerging at the interface
of social media and healthcare
28. A network of oncology patients have patients
who are as expert as most doctors in their
particular form of cancer. These patients can
provide deep insight into adverse events and are
regularly sharing insightful clinical information
that is far more detailed than a typical AE report,
but they want to be active participants in their
disease – including the AEs.
How do we make them active partners vs dumb
AE reporting terminals?
29. A medical network in the Southeast has
automated reporting of AEs from their doctors,
but the reports are sent completely blinded to
drug companies with no information except an
email address from the medical center.
A company is receiving 50 reports a week from
this email address. Are they valid? How do they
validate them?
30. A company would like to develop a baseline of
searches and tweets for their drugs so that they
can monitor changes in baseline searching and
tweeting. These changes in baseline could be
possible AE signals.
The company declines to pursue this because
they will be forced to review, follow up on and
report many potential AE reports and this
workload would completely overwhelm their
pharmacovigilance department.
31. Each of these scenarios points to fundamental
changes in our concepts of:
- Reports from pts vs HCPs and hard separation
from patients as reporters;
- Verifying identify of a
reporter and the “four
elements”
- The binary distinctions of
reportable vs onreportable
or serious vs nonserious
32. “Neither a wise man nor a brave man lies
down on the tracks of history to wait for
the train of the future to run over him.“
Dwight D. Eisenhower
Flickr: Ruud Welton
33. No amount of re-interpreting the current
regulations or messing around the edges of
our current systems will fix this problem.
We need to recognize that we are being
given a chance to make history, or fight
against it.
34. The implications are scary but clear: we
need to rethink the regulations; we need to
envision new ways to collect data; we need
to move away from an assembly-line model
and ivory tower mentality toward an
interactive, transparent approach.
And we are the ones to do this - we have
the accumulated knowledge of safety and
the expertise and wisdom to address it.
35. In asking us to make
these deep and
jarring changes, I am
clearly an
unreasonable man…
But that’s not a
reason to stop…
Michael
Ibara’s
picture
goes here
