Google Sidewiki is a new technology, released by Google in September 2009 that allows users to read and post comments on virtually any website. This offers a direct line of communication between company and customer that has historically happened behind closed doors, if at all. In a regulated industry, such as the biotechnology, pharmaceutical or medical device industry, this poses financial and business risks…and potentially some rewards.
How it works: Sidewiki is included in the latest version of Google Toolbar. Once installed, a user clicks on the Sidewiki button and a side panel appears to the left of the webpage. In that side panel, other users’ comments are displayed, and a user can add their own comments to the discussion. As owners of the website, companies are able to control the first entry to the Sidewiki using the Google Webmaster tool.
User base: Sidewiki’s user base is still quite small. A subset of internet users have Google Toolbar. Of the users that have the newest version of Google Toolbar, only a subset know Sidewiki is included. And of that number, only a small group will actually read and/or post Sidewiki content. Even smaller still is the group that will have interaction with a specific drug or device and decide to post commentary on the Sidewiki of that product’s website.
Implications: However small the current user base, the marketing, legal and regulatory groups in highly regulated industries are paying attention. The major implications, at least for the pharmaceutical industry, are in the areas of public relations (user responses to the success or failure of a medication), off-label usage (the practice of prescribing pharmaceuticals for an unapproved indication), and adverse event (AE) reporting (reporting of any adverse change in health or “side-effect” that occurs in a person who is taking a specific drug). While good and bad publicity can have extensive implications for pharma companies, the majority of the discussion on Sidewiki centers on off-label usage and AE reporting.
Under current FDA regulations, companies are limited in their ability to discuss off-label usage with prescribing physicians and patients. The ability for an open discussion of off-label usage linked to the manufacturer or drug’s website, even if not officially sanctioned, could be constituted as participation in the discussion. Companies also must track and report AE and serious AEs (SAEs) to the FDA. However, it is unclear whether a drug company responsible for reporting an AE/SAE posted in their Sidewiki. To date, the FDA has not commented on Sidewiki usage or provided any guidance or regulations.
Perspectives/Responses: There are already many perspectives on how Pharma should react to the availability and usage of Sidewiki. One option is simply to ignore that Sidewiki exists and, unless/until the FDA provides guidance or regulation, act as if Sidewiki functionality does not exist. While this is a possible option, there seems to be little support for this option. The majority of responses have been to actively respond to Sidewiki, by either blocking its usage through technical means or monitoring the content and engaging users either offline or directly, as part of the conversation.
Conclusion: Ultimately, I believe that life science companies will have no choice to block Sidewiki as, if Google allows a site to block it, someone else will come out with a tool that circumvents the restriction. With respect to monitoring and engaging, the philosophy of a “risk-based approach” comes to mind. Unless and until the FDA comes out with targeted guidance or regulation, companies should determine a strategy, publish a first entry to the Sidewiki noting that their corporate policy is that any content placed in the Sidewiki is “outside” the FDA reporting structure and to contact them using the appropriate methods for adverse events or questions about off-label usage.
Scott Dicks
Additional Reading:
- Sidewiki: What’s Pharma to Do? Benjamin Curtis, MicroMass
- Weekly Digital News: Sidewiki, Game Changer for Pharma Molly Hippolitus, Spectrum Science
- Sidewiki, Pharma and Forced Transparency Heather Snow, Account Director, Waggener Edstrom
Tags: IT Solutions
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