I don’t know how I missed this one, but thanks to the Pharma 2.0 blog and someone I follow on Twitter (sorry — I don’t remember who) for alerting me to a recently published (August 2008) EXCELLENT white paper by Nielsen Online on:

“Listening to Consumers in a Highly Regulated Environment — How Pharmaceutical Manufacturers Can Leverage Consumer-Generated Media” (registration required).

Melissa Davies (Nielsen Analyst and author of the article. Nice blog, too!) does a great job providing an overview of some fundamental issues that pharma struggles with when it comes to Social Media and UGC (user generated content). Chief among those is, of course, the issue of Adverse Event (AE) reporting, which is a key focus of this paper and is nicely called out with some great information.

She also goes on to provide many examples on how and where pharma can start with social media; all of which I completely agree with and some which are very similar to the suggestions I made in my presentation on Can Pharma Make a Business Case for Social Media.

Here are some excerpts from the whitepaper…

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…

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…

Most online discussion communities discourage the use of personally identifi able information. This is especially true within healthcare communities, where personal privacy is even more carefully guarded… 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 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.

Source: Nielsen Online Healthcare Whitepaper (2008)

After the discussion on regulatory concerns and AE reporting, Davies goes on to present some great suggestions for “The Benefits of Listening” and some great ideas for “Getting Started”. Here are some of the subject headers for those ideas…

Listen to the Conversation

• Head online to a discussion board and start reading
• Conduct an online search on the brand
• Visit Wikipedia and see what information has been posted about the brand
• Check for consumer-created videos about the brand

Facilitate the Conversation

• Go where the audience is
• Provide materials that will help patients better understand their condition and its treatment
• Share condition information or how-to’s for treatment
• Incorporate the voices of actual patients through personal stories on the brand site
• Allow and encourage patients to link to these resources from other sites

Join the Conversation

• Consider starting a blog
• Appoint someone from the brand team to take an active role in online discussion

As you can see, many of these concepts/ideas are similar to what I presented in my slides as well, which is really great, since it shows that we are in agreement and share the same vision for where Pharma needs to head with Social Media.

Well, this one is definitely getting filed as a MUST READ. Great article, Melissa Davies!!! Looking forward to seeing more Social Media in Pharma articles.

It took me a while to clean up the slides, not so much in terms of the actual content, but more on the visuals, numbers, and attributions. Here’s a list of the major changes from the original presentation:

• Edited images that were blur and/or would not display on PC
• Replaced images that were NOT covered by a Creative Commons license
• Removed embedded videos
• Added some details to MS Academy Mobile case in place of video
• Added resource links and contact details at end of presentation

As you can see, none of the changes significantly affected the main content that was presented, so it’s pretty much the same deck with a few minor adjustments for “public release”. The sections/topics I cover in this presentation are still the following:

1. What is Social Media?
2. What are the main hurdles?
3. Why is it important?
4. Where does it fit in?
5. How do I get started?
6. What strategies can we use?
7. How about regulatory concerns?
8. What about ROI?
9. Final Thoughts

Over the next few weeks, I hope to cover each of the sections in more detail via this blog, so do keep a look out. In the mean time, feel free to send an email or tweet (@shwen) with any questions or leave me a comment about them. Would love to hear your feedback!

Also, if you attended the Digital Pharma conference and/or are thinking about attending Digital Pharma 2009, please send me your thoughts, ideas, feedback on what value and opportunities you would like to experience at this conference. Since I am chairing it next year, I hope to really bring the voice of the participants into the development of the conference program!

NOTE: I have decided to cover the presentaiton under a Creative Commons Attribution and Share Alike license.

The issue of convincing upper management seems to be a BIG issue here at the EyeForPharma eCommunications and Online Marketing Summit – lots of questions from audience about this.

Coincidentally, just last week, I spoke at Digital Pharma 2008 about making a business case for social media in pharma and how to get buy-in. As part of my “opening argument”, I presented the construct that the issues we face in pharma are actually (mostly) shared among all corporate/ enterprise organizations and the only unique hurdle is really the regulatory and legal issues that the industry is held to.

So, as I am still cleaning up the slides from my talk (issues with some images I used) before I post them here on the blog, I thought I would point you to a post by Laura Finton (aka Pistachio — a fellow Bostonian) who brings up some really good ideas for how to get buy-in from upper management in general. Not pharma specific, but don’t forget — most of these issues we share with other enterprises and also, it’s always good to look outside to bring ideas in.

You can read the post on the Pistachio Blog, but here are some highlights:

It’s time to start teaching others how to “fish” and derive value using social media. Social media can create value throughout the enterprise in many different practice areas…

Step off your enthusiasm about how “cool” all this stuff is and cut straight to the value. Speak their language and address their needs and pains. Demonstrate how core business processes and challenges can be done better…

Get laser focused on management’s existing business problems and pains. Apply the tools and opportunities you know about to the priorities they know they already have…

Don’t forget folks, this stuff can be really SCARY. That’s okay. Encourage them to take a flexible stance, to start dipping their toes in, and to remain learning-focused whether or not they are ready to jump in whole hog. Some of my social media agency colleagues may disagree with this, but I think it’s okay for a company to engage in an extended listening period, where they dive deep into social media listening without necessarily responding.

Let’s face it – at this stage, many of these corporate efforts – particularly in the healthcare field — don’t quite match what you or I do when we use Facebook or Twitter or engage with others online… While I would argue that what is being done is a good start, it nonetheless begs the question – why not more?

Take the case of what we had to think through as we developed THIS little ‘ole blog.

In addition to our well-known consumer products, Johnson & Johnson also sells prescription medicines and medical devices — which are highly regulated products. That’s where things become complex. Among the many considerations we had to take into account as we tried to move from simply broadcasting messages to engaging in conversations, we had to sort out how we would handle comments that could include reports of adverse events (which legally must be reported to the FDA — something we routinely do) – and could include a discussion of so-called “off-label” or unapproved uses of our products, which we do not support or encourage.

Ultimately, the decision was reached, right or wrong, to create a comments policy that would encourage comments that would be “on topic” – as well as to not allow comments that could get us into legal or regulatory trouble…

Clearly there need to be some measures put into place to mitigate the risk of legal or regulatory liability. However, the more hurdles that are put into place, the less credible, useful or open those online efforts become, and in the end you may be left with something that could be criticized as being more akin to a traditional, one-way communications effort.

And so what we have ended up doing in many cases is take some small steps to get more comfortable with getting involved. We are also making sure we have processes in place to handle adverse event reports and that we have responsible people involved who can respond quickly to questions.

At the same time, projects like JNJBTW and the Johnson & Johnson health channel on YouTube are giving us some great experience.

I think Marc has really said it perfectly, in terms of where we are today with the adoption of social media in the healthcare industry (you can read my response to Marc at the bottom of the post here).

It’s a real conflict of interest, as this industry tries to engage in a conversation with it’s customers — both consumer and professional — without overstepping the gray boundaries that it is regulated by. But as more and more companies in the industry start to push forward with new social media initiatives (such as YouTube, Facebook, and Twitter), the momentum will build, we’ll get more, and ultimately establish better boundaries and processes for operating in this space.

As for right now, like Marc says, we’ll take small steps and get great experience — the most important thing, is that we need to at least try!