Social Media and the Future of Adverse Event Reporting

Social Media and the Future of Adverse Event Repor8ng John Mack Publisher, Pharma marketing News & Pharma Marketing Blog @pharmaguy on Twitter johnmack@virsci.com

2 Agenda  Pharma’s current use of social media Who are the leaders? Need for FDA guidelines  Solving the adverse event problem The AE red herring Whose problem is it anyway? Social media is the solu8on, not the problem  Conclusion

3 Pharma’s Use of Social Media*  Pharma and Healthcare Social Media Wiki 55 TwiNer Accounts (excluding personal pharma ppl) 45 Facebook Sites 35 YouTube Sites 31 Brand‐Sponsored Pa8ent Communi8es 19 Blogs You are not likely to find any adverse events mentioned on any of these sites, except perhaps for sponsored communities. Most have comments turned off or review comments before they are posted. *Not all are specifically sites owned and operated by FDA-regulated companies.

4 Dosie Awards Finalists TwiNer Accounts AF Stat (sanoﬁ‐aven8s) JNJComm (J&J’s Marc Monseau) Race with Insulin (Novo Nordisk) 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’re S8ll Friends I called this tweet “Sleazy Twitter Spam”

7 Dosie Awards Finalists Best Brand‐Sponsored Pa8ent Communi8es Accu‐Check Diabetes Link (Roche) Children with Diabetes (J&J Lifescan) Diabetes Handprint (J&J Lifescan) Crohn’s and Me (UCB) Voices of Diabetes (Novo Nordisk)

“Real Stories” on some sites may be authentic, but not user-generated content, which is the hallmark of social media.

9 Dosie Awards Finalists Pharma YouTube Channels Goinsulin (sanofi‐aven8s) Johnson & Johnson Health Channel Pfizer Europe Pfizer UK (the rat video!) Most pharma YouTube channels are disease information sites. Some have patient story videos that have been professionally produced, not user-generated. Most channels have comments turned off.

10 Dosie Awards Finalists Pharma Blogs More Than Medicine (GSK) JNJBTW (J&J) Think Science Now (Pﬁzer) AZ HealthConnec8ons There are very few pharma blogs. A couple of disease or product- related blogs have gone defunct after the person responsible has left the company (eg, Centocor 411, alli blog). Those that are left mainly focus on corporate news and views. You won’t find any AEs here.

11 Dosie Awards Finalists Facebook Pages Changing Possibili8es in Hemophilia (novo nordisk) The Coali8on to Prevent Deep Vein Thrombosis (snaoﬁ‐aven8s) Gardasil (GSK) Johnson & Johnson VOICES (sanoﬁ‐aven8s)

S‐A’s VOICES: First Case of “AE” Mishandling This is what happens when you don’t implement a policy for handling user-generated content.

13 AERs & Regula8on of Pharma Social Media  FDA Public Hearing  AE Repor8ng Requirements a Major Concern PMN Survey Results Industry Comments to FDA  Is It a Red Herring? Nielsen Data Pa8entsLikeMe Data TwiNer Study

14 FDA Public Hearing/Docket  14 NOV LeNers Regarding Paid Search Engine Ads Issued March, 2009 Leads to Call for Public Hearing/Guidance  Part 15 Hearing held Nov 13 ‐ 13, 2009: “Promo8on of Food and Drug Administra8on‐Regulated Medical Products Using the Internet and Social Media Tools”  Docket No. FDA‐2009‐N‐0441 open for comments through February 28, 2010  Drao Guidance Expected by End of 2010

15 Issues Accountability Fulﬁlling Regulatory Requirements Pos8ng Correc8ve Informa8on Links Adverse Event Repor8ng  What Techniques are Used by Pharma to Monitor Adverse Events on Social Media Sites?  How is Adverse Event Informa8on from Social Media Sources Processed by Pharmacos?  Challenges Handling Adverse Events Found on SM Sites  Uncertain8es Regarding Repor8ng Adverse Events Found on Social Media Sites

16 Pharma Marke8ng News Survey Overview  Online from 9/20/2009 through 2/25/2010  Included All 19 ques8ons from FDA  Tallied votes on speciﬁc answers/solu8ons  Plus comments  SubmiNed Results to Docket  274 Respondents  731  comments

17 Social Media AE Uncertain8es Adverse Event Reporting What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?  Uncertainty regarding the true iden8ty of the reporter (anonymous source)  Uncertainty regarding the true iden8ty of the pa8ent (no pa8ent named)  Uncertainty regarding the iden8ty of the drug (eg, reporter refers to "sleep pill" rather than brand name of drug)  Uncertainty regarding the seriousness of the event reported

18 Social Media AE Challenges Adverse Event Reporting What challenges are presented in handling adverse event information from these sources?  The amount of informa8on from these sources is poten8ally too vast to be processed economically (lack of resources)  Finding adverse event informa8on from these sources is like ﬁnding a needle in a haystack (too daun8ng)  The informa8on is usually incomplete and does not meet the requirements for submirng a meaningful AER (not ac8onable)  There are many poten8al issues that won't fully be known un8l the prac8ce of monitoring social media for AEs is more prevalent (unknown issues)

19 Industry Comments re: Privacy Issues  PhRMA raised privacy issue: FDA should not force manufacturers to seek personal health informa8on from pa8ents or reporters in a public forum  Lilly also cited privacy issues and said “Na8onal and interna8onal privacy laws …may preclude sponsors from aNemp8ng to obtain follow‐up informa8on… any aNempts to request personal informa8on create signiﬁcant mistrust in any company or other en8ty aNemp8ng to obtain that informa8on”

20 Industry Comments  Novar8s suggested that FDA redeﬁne “iden8ﬁable reporter” as “privately contactable” (e‐mail address w/o name, phone number is not suitable)  AstraZeneca suggested e‐mail address or Facebook contact alone is suitable  J&J proposed that the technology of the Internet be used to assist in rou8ng poten8al adverse events to the FDA  AbboN  suggested FDA make available a user‐friendly system through which web users can report events directly to FDA  as was suggested by speakers at the public hearing

21 AE Repor8ng Widget “One‐Click” Access to FDA and/or Pharmaco AE Repor=ng System Pharmaceu8cal companies could post FDA approved widgets on their drug.com Web and social networking sites.

Problems with MedWatch  Garbage In, Garbage Out Unknown to many pa8ents Complicated form Fails to capture important AEs Doctors “downgrade symptoms” and fail to document AEs in fear of being sued Passive vs. Ac8ve System Social media tools and networks may help overcome some of these problems. First, let’s see what pharma companies are doing to handle AEs on how frequently AEs are encountered on social networks.

23 Monitoring & Processing AEs  In terms of processing AEs on company‐owned social media sites, Sanofi‐ Aven8s recommends the following monitoring "parameters:" 1. Development of search terms (product/disease specific) and 8meframes 2. Development of process for iden8fying and transferring poten8al adverse events to the company's Pharmacovigilance department 3. Training monitoring staff (in‐house and/or vendor) on the aforemen8oned process 4. Training vendors on company standard opera8ng procedures (SOPs) for adverse event repor8ng 5. Internal/vendor audits to assess compliance How many pharma companies have such parameters in place in not known. 46% of pharma respondents to the PMN Survey did not know or said their companies had no SOPs.

Are J&J Agents Trolling for Adverse Events on the Internet? I am a member of BzzAgent, an online networking site that offers free trials or products to people 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 about their products. It was all couched in terminology implying that I would only be doing this as a representative of J&J, and only because it was "required by law" for all J&J employees to report any and all "adverse events" associated with use of J&J products. It mentioned that I would be under obligation to report anything I heard, even if on the internet, including contact information for the person stating the problem. Nothing about getting their permission to relay that 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 the requirements for reportable AEs are met. Therefore, J&J is asking these consumers to scoop up and report everything, which makes it necessary for J&J to sift through these "trolled" reports to find any that meet the requirements for reporting to the FDA. No wonder many pharmacos find this too daunting a task and give up on getting involved in social media.

25 AEs Found on Social Media Sites  BuzzMetrics/Nielsen Study  It was feared that spontaneous consumer feedback might contain high rates of AEs as consumers candidly, and some8mes anonymously, share their experiences online  An analysis of 500 healthcare‐related messages posted online across mul8ple disease categories found only one message that incorporated the informa8on needed to meet all four of the FDA’s AE repor8ng requirements Mostly because comments were anonymous. No attempt made to identify reporter.

26 AEs Found on TwiNer  “Dissemina8on of health informa8on through social networks: TwiNer & an8bio8cs  971 TwiNer status updates (“tweets”) that men8oned “an8bio8c” or “an8bio8cs” were analyzed  113 (12%) were categorized as “side eﬀects/nega8ve reac8ons”  Authors say that social networks can “poten8ally be used to gather real‐8me health data”

27 Pa8entsLikeMe  An online community of pa8ents (registered users)  Randomly selected 500 forum posts from among 364,000 in 2009  7% (35) of these incorporated all four elements necessary for reportable AEs  “Given our current membership of approximately 55,000 pa8ents represen8ng only 15 diseases among hundreds that we plan to build, the contribu8on to drug safety and public health could be substan8al.”  if pa8ents were given the right tools that facilitate access to their personal medical data, the 8me required to report an AE to the FDA could be reduced by as much as 44% (from 36 minutes down to 20 minutes).

UCB‐Sponsored PLM Epilepsy Community  Goal: Generate pa8ent‐reported outcomes that may help UCB beNer understand how pa8ents live with epilepsy and help advance epilepsy care.  Provides disease tracking tools  Deployed a system for repor8ng adverse events to FDA “UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.” -- Peter Verdru, MD, UCB’s Vice President of Clinical Research

If Pa8ents Know Best…  Dr. Ethan Basch, Memorial Sloan‐KeNering Cancer Center, is developing an electronic pa8ent‐reported system for monitoring and repor8ng symptoma8c AEs that pa8ents may experience during treatment Expense to implement on a large scale across many diﬀerent treatments Social Networks like PLM are FREE electronic systems that can be used for capturing adverse events Dr. Basch might do well to get his survey out to pa8ents who are already self‐organized around treatments on social media sites

Reporter “Noise” PhRMA contends that the “potential value of safety information taken from third party web sites contributing to a benefit-risk assessment of a medicine is likely to be low when compared with other sources of data including randomized controlled trials, observational data and spontaneous data.” This may be another example of the drug industry being out of synch with patients and physicians.

31 Resources  Pharma Marke8ng News − Monthly electronic newsleNer − 7,300 opt‐in subscribers − Ninth consecu8ve year of publica8on − www.news.pharma‐mk8ng.com  Pharma Marke8ng Blog – 25,000 visitors per month – pharmamk8ng.blogspot.com/  PharmaGuy TwiNer Account – 5,600 Followers – TwiNer.com/pharmaguy

32 Contact Informa8on John Mack Follow me on Twitter: http://twitter.com/pharmaguy Facebook page: http://www.facebook.com/pharmaguy www.news.pharma-mkting.com www.pharmamkting.blogspot.com johnmack@virsci.com 215-504-4164 215-504-5739 (Fax)

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Social Media and the Future of Adverse Event Reporting

by Pharmaguy on Apr 20, 2010

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Social Media and the Future of Adverse Event Reporting — Presentation Transcript