One of the most common refrains I hear from pharma execs is that they are reluctant to participate in social media because of the potential regulatory implications. While I would never discount these concerns, I wanted to point to an excellent white paper recently published (August 2008) by Nielsen Online: Listening to Consumers in a Highly Regulated Environment: How Pharmaceutical Manufacturers Can Leverage Consumer-Generated Media. The section that most caught my attention focused on the rate of adverse events found on message boards and social networks. Think it's high? Think again. The study found that only 1 in 500 messages analyzed met all four of the FDA’s AE reporting requirements. Read the excerpt below to get more details. I think the entire paper is well worth a read and you can download it here at no charge.
Thank you to Melissa Davies, the author and research director at Nielsen, who granted permission to excerpt the section on Adverse Events from Nielsen Online's August 2008 white paper - Listening to Consumers in a Highly Regulated Environment: How Pharmaceutical Manufacturers Can Leverage Consumer-Generated Media
Social Media and Adverse Event Reporting
Any pharmaceutical company considering an entry into the social media space will naturally wonder about discussion of adverse events. Are consumers sharing information online that would indicate an adverse experience? Does social media monitoring trigger the AE reporting requirement?
At this writing, there is no FDA guideline or regulation that specifically covers the content of online discussion in a way that is different from reporting AE information derived from any other source. Current FDA guidelines give four parameters for submitting information about adverse experiences: the pharmaceutical company should have knowledge of (i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome. (From FDA’s "Guidance for Industry: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report," issued August 1997; available online at: http://www.fda.gov/cder/guidance/1830fn1.pdf.) According to the guideline: “If any of these basic elements remain unknown after being actively sought by the applicant, manufacturer, or licensed manufacturer, a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances” (emphasis added). A draft guideline for filing individual case safety reports related to OTC treatments was posted on the FDA website in October 2007; it reiterates these same four parameters and again states that the responsible person should “wait to submit a report on the incident to the FDA until the information is obtained.” This raises a key question: When adverse experiences are mentioned within consumer-generated media (CGM), do they meet the FDA’s criteria for reporting?
In a recent Nielsen analysis of 500 healthcare-related messages posted online across multiple disease categories, Nielsen’s BuzzMetrics analysts found only one message that incorporated the information needed to meet all four of the FDA’s AE reporting requirements. In this message, a caregiver whose mother was taking chemotherapy reported that her mother experienced abdominal fluid retention, noted that this was not a listed side effect of the medication, and inquired in the online community whether this fluid retention might be a sign that the medication was working.
A note on identifiable reporters: Though the FDA guideline does not specify what constitutes an identifiable reporter, the 2007 draft guideline for OTC reporting notes that in order for an AE report to be submitted to the FDA, there should be “sufficient information for the responsible person to follow-up, such as a phone number or e-mail address.”
Most online discussion communities discourage the use of personally identifiable information. This is especially true within healthcare communities, where personal privacy is even more carefully guarded. For example, WebMD’s Terms and Conditions of Use include the following: “To protect your privacy, you agree that you will not submit any media that contains Personally Identifiable Information (like name, phone number, e-mail address or web site URL) of you or of anyone else.” Other websites use similar language to caution participants against revealing personal information.
In the recent analysis of 500 messages, Nielsen’s BuzzMetrics analysts found that 56 messages (11%) contained identifying information that could be used to reach out to an individual to follow up on a possible AE report. It is important to note that all of these messages came from Yahoo! or Google groups, rather than from discussion boards. Groups use their members’ e-mail addresses as their online identification; this is a key difference from discussion boards, which use less identifiable screen names for members’ online ID. This use of e-mail addresses provides contact information that could be used to follow up with a reporter to gather the details that would be needed for an AE report.
14 messages mention both a specific medication and an identifiable reporter 4 messages mention an adverse experience and include an identifiable patient and a specific medication 1 message also includes an identifiable reporter
Among 500 messages analyzed, one message incorporated all four AE reporting criteria
It is clear that a pharmaceutical company that aggressively monitors social media may pick up the occasional AE within patient/caregiver online discussion. Nielsen Online’s experience is that this happens very rarely, with a volume that is entirely manageable within companies' broader AE monitoring programs.