social media and the future of adverse event reporting
DESCRIPTION
This is the presentation I will make at the Drug Safety Congress on Thurs, April 22, 2010: http://bit.ly/9Bmo5MTRANSCRIPT
SocialMediaandtheFutureofAdverseEventRepor8ng
John MackPublisher, Pharma marketing News &Pharma Marketing Blog@pharmaguy on [email protected]
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Agenda
Pharma’scurrentuseofsocialmedia
Whoaretheleaders?
NeedforFDAguidelines
Solvingtheadverseeventproblem
TheAEredherring
Whoseproblemisitanyway?
Socialmediaisthesolu8on,nottheproblem
Conclusion
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Pharma’sUseofSocialMedia*
PharmaandHealthcareSocialMediaWiki
55TwiNerAccounts(excludingpersonalpharmappl)
45FacebookSites
35YouTubeSites
31Brand‐SponsoredPa8entCommuni8es
19Blogs
You are not likely to find any adverse events mentioned on any ofthese sites, except perhaps for sponsored communities. Most havecomments turned off or review comments before they are posted.
*Not all are specifically sites owned and operated by FDA-regulated companies.
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DosieAwardsFinalists
TwiNerAccountsAFStat(sanofi‐aven8s)
JNJComm(J&J’sMarcMonseau)
RacewithInsulin(NovoNordisk)
Roche
Xpresskindness(Allergan)
Most pharma Twitter accounts are focused on company news.Recently, however, non-branded campaigns focused on disease-awareness or cause marketing have been launched.
We’reS8llFriends
I called this tweet
“Sleazy Twitter Spam”
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DosieAwardsFinalists
BestBrand‐SponsoredPa8entCommuni8esAccu‐CheckDiabetesLink(Roche)
ChildrenwithDiabetes(J&JLifescan)
DiabetesHandprint(J&JLifescan)
Crohn’sandMe(UCB)
VoicesofDiabetes(NovoNordisk)
“Real Stories” onsome sites may beauthentic, but notuser-generatedcontent, which isthe hallmark ofsocial media.
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DosieAwardsFinalists
PharmaYouTubeChannelsGoinsulin(sanofi‐aven8s)
Johnson&JohnsonHealthChannel
PfizerEurope
PfizerUK(theratvideo!)
Most pharma YouTube channels are disease information sites. Somehave patient story videos that have been professionally produced, notuser-generated. Most channels have comments turned off.
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DosieAwardsFinalists
PharmaBlogsMoreThanMedicine(GSK)
JNJBTW(J&J)
ThinkScienceNow(Pfizer)
AZHealthConnec8ons
There are very few pharma blogs. A couple of disease or product-related blogs have gone defunct after the person responsible has leftthe company (eg, Centocor 411, alli blog). Those that are left mainlyfocus on corporate news and views. You won’t find any AEs here.
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DosieAwardsFinalists
FacebookPagesChangingPossibili8esinHemophilia(novonordisk)
TheCoali8ontoPreventDeepVeinThrombosis
(snaofi‐aven8s)
Gardasil(GSK)
Johnson&Johnson
VOICES(sanofi‐aven8s)
This is what happens when youdon’t implement a policy for handlinguser-generated content.
S‐A’sVOICES:FirstCaseof“AE”Mishandling
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AERs&Regula8onofPharmaSocialMedia
FDAPublicHearing
AERepor8ngRequirementsaMajorConcern
PMNSurveyResults
IndustryCommentstoFDA
IsItaRedHerring?
NielsenData
Pa8entsLikeMeData
TwiNerStudy
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FDAPublicHearing/Docket
14NOVLeNersRegardingPaidSearchEngineAdsIssued
March,2009LeadstoCallforPublicHearing/Guidance
Part15HearingheldNov13‐13,2009:“Promo8onofFood
andDrugAdministra8on‐RegulatedMedicalProductsUsing
theInternetandSocialMediaTools”
DocketNo.FDA‐2009‐N‐0441openforcommentsthrough
February28,2010
DraoGuidanceExpectedbyEndof2010
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Issues
Accountability
FulfillingRegulatoryRequirements
Pos8ngCorrec8veInforma8on
Links
AdverseEventRepor8ngWhatTechniquesareUsedbyPharmatoMonitorAdverseEventsonSocialMediaSites?
HowisAdverseEventInforma8onfromSocialMediaSourcesProcessedbyPharmacos?
ChallengesHandlingAdverseEventsFoundonSMSites
Uncertain8esRegardingRepor8ngAdverseEventsFoundonSocialMediaSites
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PharmaMarke8ngNewsSurveyOverview
Onlinefrom9/20/2009through2/25/2010
IncludedAll19ques8onsfromFDA
Talliedvotesonspecificanswers/solu8ons
Pluscomments
SubmiNedResultstoDocket
274Respondents
731comments
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SocialMediaAEUncertain8es
What uncertainties are there regarding what should be reported from these sources to meet FDAadverse event reporting obligations?
Uncertaintyregardingthetrueiden8tyofthereporter(anonymoussource)
Uncertaintyregardingthetrueiden8tyofthepa8ent(nopa8entnamed)
Uncertaintyregardingtheiden8tyofthedrug(eg,reporterrefersto"sleeppill"ratherthanbrandnameofdrug)
Uncertaintyregardingtheseriousnessoftheeventreported
Adverse Event Reporting
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SocialMediaAEChallenges
What challenges are presented in handling adverse event information from these sources?
Theamountofinforma8onfromthesesourcesispoten8allytoovasttobeprocessedeconomically(lackofresources)
Findingadverseeventinforma8onfromthesesourcesislikefindinganeedleinahaystack(toodaun8ng)
Theinforma8onisusuallyincompleteanddoesnotmeettherequirementsforsubmirngameaningfulAER(notac8onable)
Therearemanypoten8alissuesthatwon'tfullybeknownun8ltheprac8ceofmonitoringsocialmediaforAEsismoreprevalent(unknownissues)
Adverse Event Reporting
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IndustryCommentsre:PrivacyIssues
PhRMAraisedprivacyissue:FDAshouldnotforcemanufacturersto
seekpersonalhealthinforma8onfrompa8entsorreportersina
publicforum
Lillyalsocitedprivacyissuesandsaid“Na8onalandinterna8onal
privacylaws…mayprecludesponsorsfromaNemp8ngtoobtain
follow‐upinforma8on…anyaNemptstorequestpersonal
informa8oncreatesignificantmistrustinanycompanyorother
en8tyaNemp8ngtoobtainthatinforma8on”
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IndustryComments
Novar8ssuggestedthatFDAredefine“iden8fiablereporter”as
“privatelycontactable”(e‐mailaddressw/oname,phonenumberis
notsuitable)
AstraZenecasuggestede‐mailaddressorFacebookcontactaloneis
suitable
J&JproposedthatthetechnologyoftheInternetbeusedtoassistin
rou8ngpoten8aladverseeventstotheFDA
AbboNsuggestedFDAmakeavailableauser‐friendlysystem
throughwhichwebuserscanreporteventsdirectlytoFDAaswas
suggestedbyspeakersatthepublichearing
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AERepor8ngWidget“One‐Click”AccesstoFDAand/orPharmacoAERepor=ngSystem
Pharmaceu8calcompaniescouldpostFDAapprovedwidgetsontheirdrug.comWebandsocialnetworkingsites.
ProblemswithMedWatch
GarbageIn,GarbageOut
Unknowntomanypa8ents
Complicatedform
FailstocaptureimportantAEs
Doctors“downgradesymptoms”andfailtodocumentAEsinfear
ofbeingsued
Passivevs.Ac8veSystem
Social media tools and networks may help overcome someof these problems. First, let’s see what pharma companiesare doing to handle AEs on how frequently AEs areencountered on social networks.
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Monitoring&ProcessingAEs
IntermsofprocessingAEsoncompany‐ownedsocialmediasites,Sanofi‐Aven8srecommendsthefollowingmonitoring"parameters:"
1. Developmentofsearchterms(product/diseasespecific)and8meframes
2. Developmentofprocessforiden8fyingandtransferringpoten8aladverseeventstothecompany'sPharmacovigilancedepartment
3. Trainingmonitoringstaff(in‐houseand/orvendor)ontheaforemen8onedprocess
4. Trainingvendorsoncompanystandardopera8ngprocedures(SOPs)foradverseeventrepor8ng
5. Internal/vendorauditstoassesscompliance
How many pharma companies have such parameters inplace in not known. 46% of pharma respondents to the PMNSurvey did not know or said their companies had no SOPs.
AreJ&JAgentsTrollingforAdverseEventsontheInternet?
I am a member of BzzAgent, an online networking site that offers free trials or products topeople as a means of marketing.
I just took a survey through BzzAgent for Johnson & Johnson, which basically was more of a"contract" where if chosen, I agreed to notify J&J if I became aware of any negative talk abouttheir products. It was all couched in terminology implying that I would only be doing this as arepresentative of J&J, and only because it was "required by law" for all J&J employees to reportany and all "adverse events" associated with use of J&J products. It mentioned that I would beunder obligation to report anything I heard, even if on the internet, including contactinformation for the person stating the problem. Nothing about getting their permission to relaythat information, which stuck out given the detailed, "legal” approach of the survey.
So, basically - agreeing to be a "troll"
You cannot expect a consumer hired by BzzAgent to know if all therequirements for reportable AEs are met. Therefore, J&J is asking theseconsumers to scoop up and report everything, which makes it necessary forJ&J to sift through these "trolled" reports to find any that meet therequirements for reporting to the FDA.
No wonder many pharmacos find this too daunting a task and give up ongetting involved in social media.
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AEsFoundonSocialMediaSites
BuzzMetrics/NielsenStudy
Itwasfearedthatspontaneousconsumerfeedbackmightcontain
highratesofAEsasconsumerscandidly,andsome8mes
anonymously,sharetheirexperiencesonline
Ananalysisof500healthcare‐relatedmessagespostedonline
acrossmul8plediseasecategoriesfoundonlyonemessagethat
incorporatedtheinforma8onneededtomeetallfouroftheFDA’s
AErepor8ngrequirements
Mostly because comments were anonymous. No attemptmade to identify reporter.
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AEsFoundonTwiNer
“Dissemina8onofhealthinforma8onthroughsocial
networks:TwiNer&an8bio8cs
971TwiNerstatusupdates(“tweets”)thatmen8oned“an8bio8c”or
“an8bio8cs”wereanalyzed
113(12%)werecategorizedas“sideeffects/nega8vereac8ons”
Authorssaythatsocialnetworkscan“poten8allybeusedtogather
real‐8mehealthdata”
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Pa8entsLikeMe
Anonlinecommunityofpa8ents(registeredusers)
Randomlyselected500forumpostsfromamong364,000in2009
7%(35)oftheseincorporatedallfourelementsnecessaryfor
reportableAEs
“Givenourcurrentmembershipofapproximately55,000pa8ents
represen8ngonly15diseasesamonghundredsthatweplantobuild,
thecontribu8ontodrugsafetyandpublichealthcouldbesubstan8al.”
ifpa8entsweregiventherighttoolsthatfacilitateaccesstotheir
personalmedicaldata,the8merequiredtoreportanAEtotheFDA
couldbereducedbyasmuchas44%(from36minutesdownto20
minutes).
UCB‐SponsoredPLMEpilepsyCommunity
“UCB has an ethical and legal responsibility to report adverseevents associated with our drugs. If adverse events for any UCBdrugs are mentioned on the site, UCB is required to reportthese directly to the U.S. Food and Drug Administration (FDA).Therefore, we are working to develop and deploy a solution thatwill allow us to assess and process potential adverse events,report them to the FDA, and capture them in the UCB safetydatabase.” -- Peter Verdru, MD, UCB’s Vice President of ClinicalResearch
Goal:Generatepa8ent‐reportedoutcomesthatmayhelpUCBbeNer
understandhowpa8entslivewithepilepsyandhelpadvance
epilepsycare.
Providesdiseasetrackingtools
Deployedasystemforrepor8ngadverseeventstoFDA
IfPa8entsKnowBest…
Dr.EthanBasch,MemorialSloan‐KeNeringCancerCenter,is
developinganelectronicpa8ent‐reportedsystemformonitoring
andrepor8ngsymptoma8cAEsthatpa8entsmayexperienceduring
treatment
Expensetoimplementonalargescaleacrossmanydifferent
treatments
SocialNetworkslikePLMareFREEelectronicsystemsthatcanbe
usedforcapturingadverseevents
Dr.Baschmightdowelltogethissurveyouttopa8entswhoare
alreadyself‐organizedaroundtreatmentsonsocialmediasites
Reporter“Noise”
PhRMA contends that the “potential value of safetyinformation taken from third party web sites contributingto a benefit-risk assessment of a medicine is likely to below when compared with other sources of data includingrandomized controlled trials, observational data andspontaneous data.”
This may be another example of the drug industrybeing out of synch with patients and physicians.
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Resources
PharmaMarke8ngNews
− MonthlyelectronicnewsleNer
− 7,300opt‐insubscribers
− Ninthconsecu8veyearofpublica8on
− www.news.pharma‐mk8ng.com
PharmaMarke8ngBlog
– 25,000visitorspermonth
– pharmamk8ng.blogspot.com/
PharmaGuyTwiNerAccount
– 5,600Followers
– TwiNer.com/pharmaguy
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ContactInforma8on
John Mack
Follow me on Twitter:http://twitter.com/pharmaguy
Facebook page:http://www.facebook.com/pharmaguy
www.news.pharma-mkting.comwww.pharmamkting.blogspot.com
215-504-4164215-504-5739 (Fax)