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Developments in Medical Big Data Research: United States and China ISPOR 20 th Annual International Meeting May 19, 2015

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Page 1: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

Developments in Medical Big Data Research: United States and China

ISPOR 20th Annual International Meeting

May 19, 2015

Page 2: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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.

Page 3: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

Page 3

Mobile Apps and Social Media Impacts on AE ReportingDrug 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.”

Page 4: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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

Page 5: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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

Page 6: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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]

Page 7: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

Vernacular-to-Regulatory Translation

7

Page 8: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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

Page 9: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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

Page 10: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

•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

Page 11: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

11

MENTIONS & PROTO-AEs

6360

4098

29 411

TWITTERAll mentions

FACEBOOKAll mentions

TWITTERProto-AEs

FACEBOOKProto-AEs

01

02

03

04

Page 12: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

12

SOC Comparison to UK & US Spontaneous Reports

Page 13: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

13

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

Page 14: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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 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

Page 15: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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

Page 16: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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

Page 17: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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

Page 18: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA
Page 19: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

Mobile App vs. Traditional PharmacovigialnceComparison of Essure mobile app submissions with WHO-UMC database

Average Time for SubmissionApp users submitted in 8.5

minutes (104 words average) compared to 40 minutes via

traditional forms

Average VigiGrade ScoreMobile app submissions were

more complete than the global average in VigiBase.

“Well-documented” ReportsReports 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%overa

ll

Page 20: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

Essure Reports per Month

7 per month

FDA MAUDE132 months marketing

authorisation

103 per month

MedWatcher Mobile App19 months collaboration with patient

community

Page 21: Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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