Social media and Pharmacovigilance
Click here to load reader
-
Upload
michael-ibara -
Category
Health & Medicine
-
view
2.629 -
download
3
Transcript of Social media and Pharmacovigilance
The evolving role of social media and web based AE reporting in pharmacovigilance; is it the
future?
World Drug Safety Congress
Michael A. Ibara
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.
Social media and web based AE reporting in pharmacovigilance; is it the future?
YES
Should we apply the current laws and regulations to AEs in social media?
NO
Everything else to follow is an attempt to provide some perspective…
“The strange thing about living through a revolution is that it's very difficult to see what's going on...
…Only with the benefit of hindsight will we get a clear idea of what was going on. But the clarity that hindsight bestows is also misleading, because it understates how confusing things appeared to people at the time…
“…So it is with us now. We're living through a radical transformation of our communications environment. Since we don't have the benefit of hindsight, we don't really know where it's taking us. And one thing we've learned from the history of communications technology is that people tend to overestimate the short-term impact of new technologies — and to underestimate their long-term implications.”
Naughton, John “The internet: Everything you ever need to know”guardian.co.uk | The ObserverSunday 20 June 2010 Web 14Sep2010http://www.guardian.co.uk/technology/2010/jun/20/internet-everything-need-to-know
Naughton, John “The internet: Everything you ever need to know”guardian.co.uk | The ObserverSunday 20 June 2010 Web 14Sep2010http://www.guardian.co.uk/technology/2010/jun/20/internet-everything-need-to-know
“Social Media”Social media is media designed to be disseminated through social interaction, created using highly accessible and scalable publishing techniques. ...en.wikipedia.org/wiki/Social_media
media that is created to be shared freelyen.wiktionary.org/wiki/social_media
Social media are primarily Internet- and mobile-based tools for sharing and discussing information among human beings.[1] The term most often refers to activities that integrate technology, telecommunications and social interaction, and the construction of words, pictures, videos and audio. ...www.creativemediafarm.com/information/glossary
Social media are works of user-created video, audio, text or multimedia that are published and shared in a social environment, such as a blog, wiki or video hosting site.www.capilanou.ca/help/login-page/active-cms/glossary.html
Any website or w
eb service that utilize
s a 'social' o
r
'Web 2.0' philosophy. This in
cludes blogs, s
ocial
networks, social news, w
ikis, etc.
webtrends.a
bout.com/od/web20/a/web20-glossa
ry_2.
htm
Software tools that allow groups to generate
content and engage in peer-to-peer
conversations and exchange of content
(examples are YouTube, Flickr, Facebook,
MySpace etc)
www.bottlepr.co.uk/glossary.html
The term social media describes media that is
posed by the user and can take many different
forms. Some types of social media are forums,
message boards, blogs, wikis and podcasts.
Social media applications include Google,
Facebook and YouTube.
www.searchenginepartner.com/SEO-glossary.h
tml
Social m
edia is any form
of online publica
tion
or presence th
at allows end users t
o engage in
multi-directional co
nversations in
or around
the content o
n the website
.
www.onlinematters.com/glossa
ry.htm
A million different definitions from a million different people. But over at Duct Tape Marketing they say “[s]ocial media is the use of technology combined with social interaction to create or co-create value.”www.no2pen.com/blog/2010/01/social-media-dictionary-for-small-businesses/
A category of sites that is based on user participation and user-generated content. They include social networking sites like LinkedIn or Facebook, social bookmarking sites like Del.icio.us, social news sites like Digg or Reddit, and other sites that are centered on user interaction.searchenginewatch.com/define
“Social Media”• Web sites• Social networking (e.g., Facebook, MySpace, LinkedIn)
• Wikis (Wikipedia)
• Blogs (web logs)
• Customer forums• Micro Blogs (e.g., Twitter)
• Social bookmarking (e.g., digg)
• Location-based services (e.g., Foursquare)
• Virtual Worlds (e.g., Second Life)
• Patient Networking (e.g., PatientsLikeMe)
by example…
How to make sense of this..?
Is there a common characteristic to all this that will help us sort out how to view it vis a vis pharmacovigilance?I submit it is not some common characteristic in social mediaRather, it is a characteristic that goes deeper (or wider or longer) than social media We can use this to anchor our discussion
Current post marketing safety reporting model in U.S. is built on vertical organizations having the resources to find, collect and process safety information
Manufacturers have been the de facto owners of safety information and responsible for it (focus of regulations) because they were the only organizations able to afford the transaction costs
Two developments allow for a dramatic lowering of the ‘transaction cost’ of finding, collecting and reporting safety information- Healthcare data is moving toward greater digitization- There are established and evolving standards for exchanging safety information
Once transaction costs drop, new business models will be possible
The Hypothesis
Current post marketing safety reporting model in U.S. is built on vertical organizations having the resources to find, collect and process safety information
Manufacturers have been the de facto owners of safety information and responsible for it (focus of regulations) because they were the only organizations able to afford the transaction costs
Two developments allow for a dramatic lowering of the ‘transaction cost’ of finding, collecting and reporting safety information- Healthcare data is moving toward greater digitization- There are established and evolving standards for exchanging safety information
Once transaction costs drop, new business models will be possible
The Hypothesis
…dramatic lowering of the transaction costs of finding, collecting, reporting safety data…
Examples?
ADE Spontaneous Triggered Electronic Reports
David Westfall Bates, MD, M.Sc.Chief of the Division of General Internal Medicine at the Brigham and Women's Hospital; Professor of Medicine at Harvard Medical School and Professor of Health Policy and Management at the Harvard School of Public Health (Co-Director of the Program in Clinical Effectiveness)
Jeffrey A. Linder, MD, MPH, FACP - PI of *ASTERAssistant Professor of Medicine, Harvard Medical SchoolDivision of General Medicine and Primary Care, Brigham and Women's Hospital, Boston MA
ASTER at Brigham and Women’s
Patient Physician
EHR
Ambulatory Clinics
Service Provider
Regulator
MAH *AE Report- EHR pt data- Physician Assessment- Coding & Bus Rule Results- Electronic Wrapper
*CodingBus Rules
*
*”Triggered” Adverse Event Reports
CDISC/IHE RFD
"Overall ASTER was well-accepted by the participating physicians, who felt it was unobtrusive and who saw the public health potential.
“The clinicians, most of whom submitted no reports in the prior year - submitted over 200 reports in 3 months."
Jeffrey A. Linder, MD, MPH, FACPBrigham and Women’s Hospital / Partners Healthcare
PI on ASTER Study
• Paper or separate site
• 36 minutes
• Several days or more
• 0 reports per physician
• 1 page of information
• At point of care
• 60 seconds
• 20 minutes (triaged)
• 5 reports per physician
• 7 pages of information
Traditional ASTER
Online Drug Safety
James Allen Heywood
Extrapolating Comparision Data of Forum Posts
Forum Posts Reviewed:• Randomly selected 500 posts from
over 360,000 • Identified 35 times the number found
by Nielsen Online with identifiable patient, drug, reaction and reporter.
Extrapolating for our current number of Forum Posts we calculate:
• 1,080,000 X .07 = 75,000 potential AE
Patient
Drug
Reaction
Reporter
Drug Safety Platform: Free-text data (excluding Forum)
Free-text assessed for current clients:
• 9977 entries of free-text data• For all drugs in our database 1500
entries contained an identifiable patient, drug, reaction and reporter
Extrapolating to our current content:• There are currently over 200,000
free-text entries (Bios, Comments, Advice/Tips)
• 200,000 x 0.15 = 30,000 potential AE
Patient
Drug
Reaction
Reporter
Total AERS DataNumber of reports in FDA AERS by reporter since 2000
Potential AE Numbers from Forum Posts at 1 Million Members
Number of Forum Posts
March 2009 June 2010
Proceedings of the 2010 Workshop on Biomedical Natural Language ProcessingACL 2010, pages 117-125, Uppsala Sweden, 15 July 2010
“…we propose and evaluate automatically extracting relationships between drugs and adverse reactions in user posts to health-related social network websites.”
• Used DailyStrength health-related social network• Automated web-crawler (‘scraped the data from the
raw HTML)• Lexicon created from four resources (UMLS, COSTART,
SIDER, MedEffect)• Annotated comments• Used NLP techniques
“…we propose and evaluate automatically extracting relationships between drugs and adverse reactions in user posts to health-related social network websites.”
• Used 3,150 annotated comments• Looked for adverse effects with NLP techniques• 78.3% precision, 69.9% recall; f-measure of 73.9%• Largest source of error: Use of novel adverse reaction
phrases– “liver problem”– “burn like a lobster”– “TURNED ME INTO THE SPAWN OF SATAN”
Partial Listing of Correlations Drug Documented AEs AEs found in User Comments
Carbamazepine Dizziness, somnolence, unsteadiness, nausea, vomiting
Somnolence, dizziness, nausea
Trazodone Somnolence, headache, dizziness
Somnolence, nightmares, insomnia, addiction, headache, depression, hangover, anxiety attack, panice reaction, dizziness
Ciprofloxacin Diarrhea, vomiting, abdominal pain, headache, restlessness
Abdominal pain, malaise, nausea, allergy, somnolence, dizziness, weakness, tolerance, rash, yeast infection
…
These new business models look like they can improve the
way we do safety… they can improve public safety
made possible by
digitized healthcare data
So what’s the problem…?
The problem is…the work will kill us
Ok, but what’s the underlying problem…?
The underlying problem is that we’re using rules and regulations and concepts which were developed when data was hard to find…
…but we’re trying to use them in a world that no longer matches the one in which they were developed
hard to find
no longer matches
"A design representation suitable to a world in which the scarce factor is information may be exactly the wrong one for a world in which the scarce factor is attention.”
Herbert Simon The Sciences of the Artificial
p.144
We’ve got a safety (and regulatory) system built on sparse, hard to get safety data.
But we’re entering a world of abundant, easy to get safety data.
So what do we do?
• What we don’t do is take each case as a unique ‘one-off’ situation…– Should we monitor/collect from web sites?– Should we monitor/collect from Facebook?– Should we monitor/collect from Twitter?
• O, that way madness lies…
But…
Nielson…
?
Fallacy…• Adverse event reports are not lilies in the field…
there is not necessarily a finite number• AE reports are the product of awareness and having
a framework to observe them• One of the determinants of the number of AE
reports is how much news coverage the particular AE is getting
• So, the rate of AEs found by Nielson is not a rate set by nature, but a rate set by social interaction and awareness, and therefore subject to radical swings in frequency
A Twitter Daemon…
Script written that would post from a Twitter account …
Script uses random names, dates, drugs, AEs, and always has the 4 elements
For example…
“My uncle is 67 got terrible red rash from X”
“Mom took X lost feeling in her right arm”
Could post one tweet per minute, 24 x 7, continuously
I’m not saying we shouldn’t collect AEs in social media…
I’m saying we need to call them something different than ‘serious’ or ‘nonserious’ AEs
Maybe call them ‘Potential AE Lead Reports’ …
This data clearly could be very valuable…
…but this is where our old concepts clash with the new world
Even better.. Designate the information from social media as a ‘public good’ …
Allow searching and matching of potential adverse event ‘pointers’ by pharma, academics, others, with no attempt to apply today’s regulations on reporting
Reserve those regulations for specific programs a manufacturer runs on it’s drug …
This could address not only collection issues, but data privacy issues as well
Could law and regulation really move to this…?
1946…Mr. Causby, of Greensboro, N.C., owned 2.8 acres consituting a chicken farm and residence near an airport outside of Greensboro, North Carolina.
The flight path of planes was such that they may pass as low as 83 feet over his property.
The airport was used by United States Military bombers, transports and fighters.
They sometimes came close enough to the tops of the trees as to 'blow the old leaves off' the trees.
"As many as six to ten of their chickens were killed in one day by flying into the walls from fright."
They had to abandon their chicken business. They lost sleep and general health, becoming '...nervous and frightened...'
‘est solum ejus est usque ad coelum’
“It is ancient doctrine that at common law ownership of the land extended to the periphery of the universe…”
“…But that doctrine has no place in the modern world. The air is a public highway, as Congress has declared. Were that not true, every transcontinental flight would subject the operator to countless trespass suits. Common sense revolts at the idea. To recognize such private claims to the airspace would clog these highways, seriously interfere with their control and development in the public interest, and transfer into private ownership that to which only the public has a just claim."
“…The farmer can't make money, e.g., by charging plane who travel in his airspace - but he is entitled to compensation for damages which occurred from the invasion of his airspace, because "...the land is appropriated as directly and completely as if it were used for the runways themselves."
“…COMMON SENSE REVOLTS AT THE IDEA…”
Some suggestions
• Consider designating the social media information space a public good
• Formulate new rules to govern the use of this space• Consider new classes of reports on drug safety
– Information lead– Recurring syndrome– Well-formed adverse event– Serous adverse event
• Convene groups of informed individuals from pharma, government, academia, to start figuring out how to create the ‘Causby Solution’ for drug safety in the world of digitized healthcare