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SOCIAL
SOCIAL MEDIA & MOBILE APPS AS SOURCES FOR PATIENT REPORTED INFORMATION
Nabarun Dasgupta
Epidemico
April 24, 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.
Slides available @epidemico
Typhoid cases in Mufulira have
reached 2, 227 with health authorities
calling for increased efforts to prevent
new infections in Mupambe Township.
2, 227
#
Typhoid Mufulira
Mupambe Township
Medicine Use
Negative Reaction
Suspected Problem
Require medical attention
Life threatening
Reported
Verified
Patients don't report bad reactions because they don't know they should.
We can amplify their voices by meeting patients where they are at and filtering out noise.
Patients are speakingShouldn’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 03Meet patients
where they’re
at
Protect their
privacy
Give them
easy-to-use
tools
Data flow for detecting adverse drug reactions in
social media data.
7
DATA PROCESSING
Acquire
Filter
Curate
Causation
Describe
Collect social
media data
Detect Proto-
AEs, translate
vernacular
Reduce false
positives
Descriptive
statistics
Synthesis
of
information
Analyzing social media relies on machine- and
human-dependent processes.
8
WORK SEGMENTATION
SOFTWARE AUTOMATION HUMAN SKILL COMMUNITY
Define questions that matterTake a systematic approach to selectively analyze
data for drugs and disease where there is a lack of
understanding.
Improve data tools for efficiencyNatural language processing (NLP) and machine
learning tools can assist in reducing human
burden.
CAUSATIONDESCRIBECURATEACQUIRE FILTER
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.
9
AUTOMATED FILTERING
68%
Research-ready data available
daily.
PRECISION[+ predictive
value]
88%
RECALL[sensitivity]
Spelling VariationsCombined or invented wordsImplied phrasesInternet Vernacular Translation
lost their eyesight
seeing weird colorseeing weird colour
doublevision
couldn’t seedouble vision
blindgoogley eyed
blurry vision
changes in visioncross eyedseeing weird
vision changeblindness
cross visionvisual snow
googly eyedseeing double
making me eat like a mouseanorexic
lost appetite
#notevenhungryappetite is nonexistent
apetite surpressed
didn’t get hungry
dont want to eat
killed my apetite
miss feeling hungry
killed my appetitecan’t eatlost apetite
lost my appetiteno appetitey
lack of apetitestomach small
lost teh appetite
never hungrynever want to eat
cant eat
couldnt seecrosseyed
blurry
apetite surpressed
killed my apetitelost apetite
lack of apetite
lost teh appetite
Typos
seeing weird colorseeing weird colour
googley eyed
googly eyed
#notevenhungry
no appetitey
making me eat like a mouse
never want to eat
Visual impairment
MedDRA 10047571
Visual impairment
SNOMED 397540003
Decreased appetite
MedDRA 10061428
Loss of appetite
SNOMED 79890006
making me eat like a mouseanorexic
lost appetite
#notevenhungryappetite is nonexistent
apetite surpressed
didn’t get hungry
dont want to eat
miss feeling hungry
killed my appetitecan’t eatlost apetite
lost my appetiteno appetitey
lack of apetitestomach small
lost teh appetite
never hungrynever want to eat
cant eat
lost their eyesight
seeing weird colorseeing weird colour
doublevision
couldn’t seedouble vision
blindgoogley eyed
blurry vision
changes in visioncross eyedseeing weird
vision changeblindness
cross visionvisual snow
googly eyedseeing double
couldnt seecrosseyed
blurry
killed my apetite
1067
0
0
118
448
15
0
37
2
1
44
4
PROS
0
0
3972
387
356
12
0
15
0
1
55
5
CONS
0
0
47
0
0
1
0
0
27
1
0
PROS
0
0
115
4
0
4
0
0
113
6
0
CONS
XanaxXanax andHydrocodoneand HydrocodoneXanax and HydrocodoneHydrocodone isand Hydrocodone isHydrocodone is like blackouta blackouthaving a blackoutblackout withouta blackout withoutblackout without thedrinkingthe drinkingwithout the drinkingdrinking andthe drinking anddrinking and thehangoverthe hangoverand the hangover
Xanax Hydrocodone blackouthangover
and is likehavinga withoutthedrinkingandthe
PRO CONCOMPOSITE
SCORE
0.8208
Xanax Hydrocodone blackouthangover
and is likehavinga withoutthedrinkingandthe
•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)
15
• DESCRIPTIVE METHODS
Relevant events in Victoza® (liraglutide) history and current analysis
16
VICTOZA TIMELINE
2009
2010
2013
2014
UK APPROVAL
June 30
SOCIAL MEDIA DATA
COLLECTION BEGINS January 1
2015
STUDY ENDMarch 9
EARLIEST MHRA
MENTION?March 21
2001//
OBSERVATIONAL
STUDY
PUBLISHEDApril 8
US
APPROVALJanuary 25
FAERS DATA
AVAILABLEOctober 1
2012
10,458
All public mentions
of Victoza or
liraglutide in
Facebook or Twitter,
arising from 7,150
unique posts
ACQUIRE
368
Total number of
posts resembling
adverse events
(Proto-AEs) after
curation.
3.5% of mentions
are Proto-AEs
FILTER
158
False positive posts
removed by manual
curation
30%
CURATE
699
Drug-event pairs at
the MedDRA
preferred term level
DESCRIBE
18
OVERALL RESULTS
19
MENTIONS & PROTO-AEs
6360
4098
29 411
TWITTERAll mentions
FACEBOOKAll mentions
TWITTERProto-AEs
FACEBOOKProto-AEs
01
02
03
04
0
1
2
3
4
5
2 4 2 1
The EMA’s list of Important Medical Events (IME)
can be used to identify posts of greatest medical
consequence
22
IMPORTANT MEDICAL EVENTS
2.0%Posts with IME
23
KNOWN FREQUENCY ADVERSE EVENTS
1:10k+1:1000 1:10k1:1001:10
10
100
1k
VERY COMMONdecreased blood sugar
levels, diarrhoea,
nausea
COMMONbronchitis, 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
UNCOMMONdehydration, malaise,
itching, kidney
problems, urticaria
RARE / VERY RAREanaphylaxis, angioedema, GI
problems; pancreatitis,
hypersensitivity
10k
SOURCEemc+ Medicine Guide, Jan 16, 2015, Datapharm
medicines.org.uk
Medicine GuidePreferred terms appearing in social media and not appearing
24
7.7%Posts with HSI
“I've been on Victoza for a total of 17 days now for pre-diabetes. After the 5th day the nausea hit and it's horrible. I'm afraid to eat anything and the smell of fried foods kill me. I started on 0.6 for 7 days and now I'm up to 1.2.....when does it get better? My Dr recommended that I go back to 0.6 for a couple weeks to see if it helps. I feel nauseous, bloated, stomach hurts, dizzy at times......I have lost weight (which for me is a good thing ) but it's not good enough to keep feeling so horrible. Anyone have any suggestions for the nausea and bloatng?”
Facebook, January 23, 2015
HEALTH SYSETM INTERACTION
25
IN THEIR OWN WORDS
Typical
Proto-AEs
& Patient Benefits
@user I just restarted taking victoza which made me so sick to my stomach till my body got used to it.
Aside from the nausea (worse today) and occasional bouts of hypoglycemia (better today), four days on Victoza and down 5.3 lbs! Amazing!
Twitter, May 3, 2014
Facebook, December 9, 2014
26
IN THEIR OWN WORDS
Product
Quality
Issues
Anyone else having issues with plugger jamming on their flex pen of victoza? The only difference I see is the new needles . I had to stick myself 4 times today to get almost a full dose. Frustration. Doesn't seem related to where I am into pen, first dose, midway , last. Third pen this has happened on in a row
Facebook, December 9, 2014
27
IN THEIR OWN WORDS
Product
Tampering
I was curious and wanted to see how much of Victoza was left in the [device] after was gone. I had taken a syringe and extracted out the last amount of it. I took out 20 unites out of the pen remaining. That is well over one more dosage that could be used before throwing the pen away. The money we pay, feels like we are wasting a shot that should be there.
Facebook, March 1, 2015
28
IN THEIR OWN WORDS
Diversion &
Re-Sale
I have 2 boxes of victoza insulin pens if interested inbox for more information
Facebook, February 3, 2015
Please, if anybody is on Victoza for diabetes or insulin resistance < i ordered too much stock and it is non returnable being a fridge item > please pop in at [redacted] pharmacy .....will organise a good price to compensate for my blunder.
Facebook, February 27, 2015
29
IN THEIR OWN WORDS
Product
Pricing
Just bought 4 Victoza pens from my pharmacy (CVS). $800 out of pocket. Uggg. :(
Facebook, February 6, 2015
30
IN THEIR OWN WORDS
Off-label
Use
Had my first injection of Victoza. So if it doesn't kill me from one of side effects my sugar should stabilize. One side effect is puzzling. "For type 2 Diabetics only. Not intended for type 1 diabetics". I'm the poster child for type 1 Diabetics.
Facebook, February 6, 2015
31
IN THEIR OWN WORDS
Pancreatitis
sorry it took awhile..just got out of the hospital...the new diabetes doctor that I have took me off the Victoza....I'm not sharing this to start a war or panic but listen up please: I'm an RN and I was on VICTOZA. I got deathly sick off it, and developed Pancreatitis really bad! It was the most painful thing I ever went through and will NEVER use Victoza again!! Anyone else ever had the same thing I had?
Facebook, February 6, 2015
“FDA reevaluated more than 250 toxicology
studies conducted in nearly 18,000 healthy
animals (15,480 rodents and 2475 nonrodents).
Microscopic examinations from these toxicology
studies yielded no findings of overt pancreatic
toxic effects or pancreatitis.”
“A pooled analysis of data from 14,611 patients
with type 2 diabetes from 25 clinical trials in the
sitagliptin database provided no compelling
evidence of an increased risk of pancreatitis or
pancreatic cancer.”
"Both agencies agree that assertions concerning
a causal association between incretin-based
drugs and pancreatitis or pancreatic cancer, as
expressed recently in the scientific literature and
in the media, are inconsistent with the current
data. The FDA and the EMA have not reached a
final conclusion at this time regarding such a
causal relationship. Although the totality of the
data that have been reviewed provides
reassurance, pancreatitis will continue to be
considered a risk associated with these drugs
until more data are available; both agencies
continue to investigate this safety signal."
32
INFORMATION SYNTHESIS
JAMA Internal Medicine, Vol. 173 (No. 7), Apr 8, 2013
New England Journal of Medicine, Vol. 370 (No. 9), Feb 27, 2014
33
IN THEIR OWN WORDS
Causation?
Follow-up?
I saw the Endocrinologist today and will need a biopsy on Thyroid, for one of the 3 nodules ( I will call them my triplets, lol).... Lot's of prayers and positive thoughts would be welcomed. I'm slightly nervous because I have been taking Victoza and the side effect is Thyroid Cancer.... Damn it. So hoping and wishing that it's just a big coincidence of timing.... Deep breaths and sweet dreams..... :)
Facebook, April 2, 2014
2
23
21
158
MHRA spontaneous reports
FDA spontaneous reports (w/o multiplicate reduction)
34
REPORTING BURDEN PER MONTH
?True Incidence Rate?
How does social media volumefor Victoza (liraglutide)
compare to traditional pharmacovigilance?
Can patterns be detected sooner?
What does social media contribute?
Twitter & Facebook: Jan ‘14 – Mar ’15MHRA Drug Analysis Print: Jun ‘09 – Mar ‘15FDA FAERS: Oct ‘12 – Mar ‘14
35
CLINICAL TRIAL DISCUSSION
I'm in a Pfizer double blind ######### trial and could receive the placebo up until week 16 at which point I'm guaranteed to receive the drug.
What I don't understand is that I can't be told if I was on the placebo for the first 16 weeks. I'm not seeing any positive benefit from whatever I've been taking for 8 weeks so far, and I would really like to know at week 16 if it's the drug because then I can bail from the study at that time and move on to something else…
36
CLINICAL TRIAL DISCUSSION
He started on Thursday. He told me yesterday that he tried to chew a capsule (I'm not sure why, I think he wanted to see if it had a flavor) & it was hard as a rock. I'm assuming maybe it was eneric coated or something. He took the no flavor to mean he's on the placebo, but I actually wonder if they would bother enteric coating a placebo. Probably doesn't matter & I know we're not supposed to know anyway, just wondered if anyone else's was enteric coated.
38
LIMITATIONS OF SOCIAL MEDIA
CAUSALITYPatients may not correctly
assess causality. Define
methods to measure
probability of real world
significance.
VOLUMEVolume of reports likely to
be large. Reduce false
positives and create
automated tools to triage
information.
SIGNAL DETECTIONVery limited statistical
methods to detect problems.
Collaborate with academia,
industry and regulators to
refine methods.
PRIVACYPatient privacy expectations
and fear of government
oversight. Use publicly
available data only.
REGULATION UNCLEARWhen is there an obligation
to monitor or report? Work
with regulators and industry
to clarify guidance.
01
02
03
04
05
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