Advanced Machine Learning for Business Professionals
Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA
1. Developments in Medical Big Data Research:
United States and China
ISPOR 20th Annual International Meeting
May 19, 2015
2. Page 2
Mobile Apps and Social Media Impacts on Adverse
Event Reporting to the FDA
Nabarun Dasgupta, Ph.D.
Epidemico
May 19, 2015
The WEB-RADR project is supported by the Innovative Medicines Initiative Joint Undertaking
(IMI JU) under grant agreement n° 115632, resources of which are composed of financial
contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and
EFPIA companies’ in kind contribution.
3. Page 3
Mobile Apps and Social Media Impacts on AE Reporting
Drug Interactions May Be Difficult to Capture
May 19, 2015
Source: Larry Risen at BioTrak
“It’s just temporary.
Next time, don’t take your Rogaine and Viagra at the same time.”
4. Patients are speaking
Shouldn’t we be listening?
Beyond informing the public about the
importance of adverse event reporting, we
can take steps to encourage patients to
report.
01 02 03
Meet patients
where they’re at
Protect their
privacy
Give them
easy-to-use
tools
5. Data flow for detecting adverse drug reactions in
social media data.
5
DATA PROCESSING
Acquire
Filter
Curate
Causation
Describe
Collect social
media data
Detect Proto-
AEs, translate
vernacular
Reduce false
positives
Descriptive
statistics
Synthesis
of
information
6. Bayesian classifier
identifies posts with
resemblance to adverse
events
Dictionary translates
vernacular to
MedDRA
Multiple copies of
posts are consolidated
and PII removed
01
02
03
50 million posts that mention a medical product
have been collected. The classifier has been
trained with 360,000 manually coded posts.
6
AUTOMATED FILTERING
68%
Research-ready data available
daily.
PRECISION
[+ predictive value]
88%
RECALL
[sensitivity]
8. Spelling VariationsCombined or invented wordsImplied phrasesInternet Vernacular Translation
lost their eyesight
seeing weird color
seeing weird colour
doublevision
uldn’t see
double vision
blind
googley eyed
blurry vision
changes in viscross eyed
seeing weird
vision change
blindness
cross visionvisual snow
googly eyed
seeing doub
making me eat like a mouse
anorexic
st appetite
#notevenhungry
appetite is nonexistent
apetite surpressed
didn’t get hungry
dont want to eat
killed my apetite
miss feeling hung
killed my appetite
can’t eat
lost apetite
lost my appetite
no appetitey
lack of apetite
stomach small
lost teh appetite
never hnever want to eat
cant eat
coucrosseyed
blurry
apetite surpressed
killed my apetite
lost apetite
lack of apetite
lost teh appetite
Typos
seeing weird color
seeing weird colour
googley eyed
googly eyed
#notevenhungry
no appetitey
making me eat like a mouse
never want to eat
9. Visual impairment
MedDRA 10047571
Visual impairment
SNOMED 397540003
Decreased appetite
MedDRA 10061428
Loss of appetite
SNOMED 79890006
making me eat like a mouse
anorexic
st appetite
#notevenhungry
appetite is nonexistent
apetite surpressed
didn’t get hungry
dont want to eat
miss feeling hung
killed my appetite
can’t eat
lost apetite
lost my appetite
no appetitey
lack of apetite
stomach small
lost teh appetite
never hnever want to eat
cant eat
lost their eyesight
seeing weird color
seeing weird colour
doublevision
uldn’t see
double vision
blind
googley eyed
blurry vision
changes in viscross eyed
seeing weird
vision change
blindness
cross visionvisual snow
googly eyed
seeing doub
coucrosseyed
blurry
killed my apetite
10. • Victoza® - liraglutide [rDNA origin] injection
• Diabetes indication
• (Does not include Dec 2014 US approval for Saxenda® for chronic obesity)
• UK, US, IN, CN, EU, JP, DE, DK, NL, IE, SE, FR, MY, SG
• UK approval: 30 Jun 2009
• Public Social Media (FB & Twitter): Jan 1, 2014 to March 9, 2015
• English language only
• MHRA Drug Analysis Print & FDA FAERS (county-limited, non-duplicated)
10
• DESCRIPTIVE METHODS
13. 13
KNOWN FREQUENCY ADVERSE EVENTS
1:10k+1:1000 1:10k1:1001:10
10
10
0
1k
VERY COMMON
decreased blood sugar
levels, diarrhoea,
nausea
COMMON
bronchitis, constipation,
abdominal distension,
faster heart rate, feeling
dizzy, flatulence,
gastritis, gastro-
oesophageal reflux,
headaches, indigestion,
inflammation of
nose/throat, injection
site problems, loss of
appetite, antibodies to
Victoza, skin rash,
stomach pain, tiredness,
toothache, vomiting
UNCOMMON
dehydration, malaise,
itching, kidney
problems, urticaria
RARE / VERY RARE
anaphylaxis, angioedema, GI
problems; pancreatitis,
hypersensitivity
10
k
SOURCE
emc+ Medicine Guide, Jan 16, 2015, Datapharm
medicines.org.uk
Medicine Guide
Preferred terms appearing in social media and not appearing
14. 2
23
21
158
TWITTER
MHRA spontaneous reports
FDA spontaneous reports (w/o multiplicate reduction)
FACEBOOK
14
REPORTING BURDEN PER MONTH
?
True Incidence Rate?
How does social media volume
for Victoza (liraglutide)
compare to traditional pharmacovigilance?
Can patterns be detected sooner?
What does social media contribute?
Twitter & Facebook: Jan ‘14 – Mar ’15
MHRA Drug Analysis Print: Jun ‘09 – Mar ‘15
FDA FAERS: Oct ‘12 – Mar ‘14
15. Why do Patients Report Adverse Drug Reactions?
Data from The Netherlands Jan 2008 – Mar 2009, Top 4 responses, N=999
33%Not mentioned in patient information leaflet
The adverse drug reaction was severe
I wanted to share my experiences
The possibility for reporting just exists
54%
48%
35%
Van Hunsel, F 2010. Eur J Clin Pharmacol
16. Essure
• Implantable, permanent birth control for women
• Coils made of polyester fibers, nickel-titanium and
stainless steel, implanted into fallopian tubes
• US FDA approved 2002
• 5-year fail rate: 0.27%
• 750,000 implanted
• Potential market
20% of married women
using birth control
Copyright Conceptus, credit Wikipedia
17. Methods
• Outreach to Facebook group “Essure
Problems”
– 15,000 members
• Work with group administrators to promote
AE reporting via mobile app
– Krystal Donahue & Melanie Goshgarian
• 1,349 ICSRs analyzed from publicly redacted
versions at medwatcher.org
• WHO-UMC VigiGrade completeness scores
18.
19. Mobile App vs. Traditional PharmacovigialnceComparison of Essure mobile app submissions with WHO-UMC database
Average Time for Submission
App users submitted in 8.5 minutes
(104 words average) compared to 40
minutes via traditional forms
Average VigiGrade Score
Mobile app submissions were more
complete than the global average in
VigiBase.
“Well-documented” Reports
Reports from mobile app were
considered “well-documented” 3x more
often than global average in VigiBase
40 min
0.45
Bergvall T 2013 Drug Safety
8.5 min 0.80 56%
24%
HCP
13%
overall
20. Essure Reports per Month
7 per month
FDA MAUDE
132 months marketing
authorisation
103 per month
MedWatcher Mobile App
19 months collaboration with patient
community