Social Media & Mobile Apps as Sources for Patient Reported Information

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  1. 1. 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
  2. 2. 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
  3. 3. 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.
  4. 4. Patients are speaking Shouldnt 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 theyre at Protect their privacy Give them easy-to-use tools
  5. 5. 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
  6. 6. Analyzing social media relies on machine- and human-dependent processes. 8 WORK SEGMENTATION SOFTWARE AUTOMATION HUMAN SKILL COMMUNITY Define questions that matter Take a systematic approach to selectively analyze data for drugs and disease where there is a lack of understanding. Improve data tools for efficiency Natural language processing (NLP) and machine learning tools can assist in reducing human burden. CAUSATIONDESCRIBECURATEACQUIRE FILTER
  7. 7. 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]
  8. 8. Vernacular-to-Regulatory Translation 10
  9. 9. Spelling VariationsCombined or invented wordsImplied phrasesInternet Vernacular Translation lost their eyesight seeing weird color seeing weird colour doublevision uldnt 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 didnt get hungry dont want to eat killed my apetite miss feeling hung killed my appetite cant 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
  10. 10. 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 didnt get hungry dont want to eat miss feeling hung killed my appetite cant 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 uldnt 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
  11. 11. 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 and Hydrocodoneand HydrocodoneXanax and HydrocodoneHydrocodone isand Hydrocodone isHydrocodone is like blackouta blackouthaving a blackoutblackout withouta blackout withoutblackout without the drinkingthe drinkingwithout the drinkingdrinking andthe drinking anddrinking and the hangoverthe hangoverand the hangover Xanax Hydrocodone blackout hangover and is like having a without the drinking and the
  12. 12. PRO CON COMPOSITE SCORE 0.8208 Xanax Hydrocodone blackout hangover and is like having a without the drinking and the
  13. 13. 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
  14. 14. 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 END March 9 EARLIEST MHRA MENTION? March 21 2001 // OBSERVATIONAL STUDY PUBLISHED April 8 US APPROVAL January 25 FAERS DATA AVAILABLE October 1 2012
  15. 15. Victoza only 17 Descriptive Analysis
  16. 16. 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
  17. 17. 19 MENTIONS & PROTO-AEs 6360 4098 29 411 TWITTER All mentions FACEBOOK All mentions TWITTER Proto-AEs FACEBOOK Proto-AEs 01 02 03 04
  18. 18. 20 SOC Comparison UK & US Spontaneous Reports
  19. 19. 21 QUANTIFYING EVENTS
  20. 20. 2 4 2 10 1 2 3 4 5 Pancreatitis Hypersensitivity Angioedema Haemorrhage The EMAs 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
  21. 21. 23 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
  22. 22. 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
  23. 23. 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
  24. 24. 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
  25. 25. 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
  26. 26. 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
  27. 27. 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
  28. 28. 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
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 32. 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 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
  33. 33. 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
  34. 34. 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.
  35. 35. 37
  36. 36. 38 LIMITATIONS OF SOCIAL MEDIA CAUSALITY Patients may not correctly assess causality. Define methods to measure probability of real world significance. VOLUME Volume of reports likely to be large. Reduce false positives and create automated tools to triage information. SIGNAL DETECTION Very limited statistical methods to detect problems. Collaborate with academia, industry and regulators to refine methods. PRIVACY Patient privacy expectations and fear of government oversight. Use publicly available data only. REGULATION UNCLEAR When is there an obligation to monitor or report? Work with regulators and industry to clarify guidance. 01 02 03 04 05
  37. 37. 39 QUESTIONS? web-radr.eu @WEBRADR epidemico.com @epidemico demo.medwatcher.org @med_watcher nabarun@epidemico.com