We are in an awkward time. One topic I think about a lot lately is the extent to which engagement creates responsibility and what the limits of that responsibility are.
Here is one simple example, If I am a regular reader of blogs, am I responsible for reporting something that I clearly recognize as an adverse event that I see on that blog? I think the answer is clearly yes based on my understanding of the legal landscape. Just as it would be if I found out such information through a traditional off line channel.
But what if there is an adverse event report on the blog, but I either don't read that particular message, skim it quickly, or simply don't recognize what has been said as a potential adverse event? After all my purpose in reading widely is to learn and engage, both personally and professionally, (activities that are clearly in the public interest), not to monitor the universe of 3rd party communications for potential adverse events.
By engaging at all, have I taken on the responsibility to police all content past, present, and future that may be posted in that forum? Unfortunately, even if this is recognized as an untenable position, the innate conservatism of the pharmaceutical environment can often result in a lack of engagement at all simply because it is perceived as the safest course of all. A state of affairs that, I think everyone would agree, is not in the best interest of the public.
My personal position, and the only one that I think can make sense for companies, is that you can only be responsible for reporting what you see or hear and, even then, for what should be obvious and clear as a potential adverse event to the person reading. The FDA, and potentially congress, needs to act clearly and decisively to encourage companies to listen to these conversations, and what is being said about their products, without fear that casual and incidental issues of this kind on 3rd party blogs and communities will put them at risk.
Love to hear what people think...
As always, I have been careful to "elevate" this discussion to a more conceptual level and these thoughts are my own and do not reflect the opinions, policies, or discussions, of anyone at my company, or of my company as a whole.
It seems this issue will be a hot topic in the new Sermo community. It appears there is already research being done at Northwestern University to compare adverse events monitoring in an online community like Sermo vs. more traditional means. See http://www.sermo.com/about/partners
Posted by: msellberg | May 13, 2008 at 04:27 PM