social media & mobile apps as sources for patient reported information

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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

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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]

Vernacular-to-Regulatory Translation

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

Victoza only

17

Descriptive Analysis

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

20

SOC Comparison UK & US Spontaneous Reports

21

QUANTIFYING EVENTS

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

TWITTER

MHRA spontaneous reports

FDA spontaneous reports (w/o multiplicate reduction)

FACEBOOK

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.

37

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

39

QUESTIONS?

web-radr.eu

@WEBRADR

epidemico.com

@epidemico

demo.medwatcher.org

@med_watcher

[email protected]