Live from DC – It’s the FDA Open Forum on Internet and Social Media

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*UPDATED: Day 1 & 2 Hearing Summaries and Resources

The next 2 days (NOV 12-13) marks a VERY significant occasion in the history of social media in pharma. By that, of course, I mean that it’s the kick off to the FDA Open Hearing on Internet and Social Media — the first of it’s kind since 1996! Of course, it was just “Internet” back then — social media didn’t exist as we know it today.

The biggest irony of this meeting on INTERNET and SOCIAL MEDIA is that there’s no wifi connection or cell phone reception (the meeting room is 2 floors underground), so no one there will be able to live tweet/blog the meeting, but at least it’s an open forum. Whatever the case, those of us watching the live webcast will be live-tweeting (because we have wifi! :) ) using the hashtag #FDASM, so look out for those.

Click image for live webcast on NOV 12-13

There’s already been bevy of write-ups and resources surrounding this, so rather than write my take on it, I’m going to point to several of these so that you can get a variety of viewpoints and information…


First and foremost, if you have only one resource to turn to, then you must go to — a site put together by Fabio Gratton (Ignite Health), which aggregates a lot of key information around the event, including: speakers, panelists, agenda, links to the webcast, a live tweet-stream, and (most importantly) a list of logos from supporting groups/people, which there are plenty! In addition to that, here are some links to great information surrounding this historic event:
UPDATE (Nov 12th, 2009): Day 1 Summaries and New Links/Resources…
UPDATE (Nov 13th, 2009): Day 2 or Overall Hearing  Summaries/Links/Resources…

Wordle: #fdasm FDA & Social Media Twitter Stream Nov 12-13

Astra Zeneca Launches Corporate Blog: AZ Health Connections

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If you haven’t heard yet, Astra Zeneca US launched a new corporate blog last week, called “AZ Health Connections“; thus being the third (active) corporate pharma blog online that I know of… and GSK’s More Than Medicine, being the other two.

There’s been a number of blog “reviews” and comments about the launch of this new AZ blog and, while you would have expected lots of congratulatory remarks towards taking another step in the world of social media (they also have a Twitter feed: AstraZenecaUS), it turns out that some comments are not exactly positive so far. You can read a summary of some early commentary in Jim Edwards’ BNET article and here are some additional quotes from various sources:

BNET: AstraZeneca’s New Blog Is Slammed by Critics
The criticisms are harsh given that AZ blog editor Earl Whipple has still got his training wheels on… However, the haters do have a point when it comes to pharma company blogs generally: Firms shy away from controversy but controversy is the blogosphere’s raison d’être. unable to overcome that central contradiction, pharma blogs are often pallid affairs.’s First Corporate Blog Falls Flat
So far there have been no comments on the AZ blog. Besides the introductory post, the blog offers only company-line stances on FDA social media regulation and healthcare reform. If content can’t generate the type of product discourse pharma companies are looking for, perhaps a new approach to social media is needed to educate customers in an ethical and productive way.

EyeOnFDA: AstraZeneca Joins List of Corporate Bloggers
AZ indicates it is their desire to engage with the blog, but the early postings leave little upon which to engage.  For example, their posting on the Part 15 Social Media Meeting is purely informational about the meeting, but doesn’t provide a point of view of what AstraZeneca would say to FDA, either at the meeting or in comments posted to the docket.  Without that kind of substance, it is hard to engage.

So, as you can see, there are some doubts as to the “authentic” nature of the AZ blog, but I really like what Mark Senak (EyeOnFDA blog) wrote overall, as it’s more constructive than critical. In particular, I like what was written in the last sentence of his blog post: “But it is early yet, and this blog, like all blogs, needs time to find a voice and identify its parameters“.

IMHO, I think we are often too quick to judge and point out the negatives, usually to the detriment of any organization that is at least trying to take a step forward in this space. Many “experts” and opinionated individuals  often berate the pharma industry for not jumping-in and engaging in social media; yet when they try, they are often criticized for only taking baby steps and not doing the cannon ball straight into the deep end.

Personally, I think AZ’s blog is a great start. In fact, ANY start is a great start. I believe that with every initiative, there is an opportunity to learn, adapt, and evolve. Particularly with this industry, I’ve always said that it’s better to have dipped a toe and tested the waters, than jump right in and get shocked. From what I’ve seen in the past (especially on Twitter), many companies are only able to start out within a comfort-zone, but then over time, they slowly adapt and evolve as they (and their legal, regulatory, etc. colleagues) get more comfortable and more experience. Yes, it’s a bit of a “tortoise approach”, but remember — the tortoise wins the race :-) !

What really bothers me, is when “purists” and “antagonists” start criticizing new efforts for playing it safe (e.g. turning off comments for YouTube videos or reviewing blog comments before posting)…  As it is, an initiative like a corporate blog takes a lot of time, effort, planning, and approval before it can launch, never mind the need to justify it’s existence and purpose (“what’s the ROI for that???“). To then have a slew of negative comments/publicity hit you at your very first step, can only hinder progress or even scare some into shutting down altogether, thereby taking steps backward (the once-bitten feeling).

Instead, it would be helpful to have constructive advice like those that Mark provided in his blog — he blogs about what they did right:

In setting up their blog, AZ has done a few smart things.  They have a very detailed comments policy that was obviously put together by a fleet of lawyers.  They state that they reserve the right to edit or not publish some comments.  They also state that this blog is not the place for discussion of specific product issues.  But the smartest thing they did in my mind is to provide referrals for people if they do want to report a problem with a prescription product.  That is smart because at some point in the future, companies are going to be compelled to be more aggressive and proactive in adverse event reporting – so why not start now?  It is also smart because it reinforces the message that the blog is a platform for other discussion.  There is also an elaborate “Legal” tab.

And he also blogs about areas to improve upon (which may not be obvious to the authors):

A visible indication of possible multiple authors is the fact that the postings each have different fonts and spacing, indicating that they were drafted in Word somewhere and cut and pasted into the blog without stylizing consistently first.

Whatever the case, I hope that AZ (and any other current or future corporate blogs) will learn, adapt, and evolve through the feedback they receive and not shy away — the journey of a thousand miles (with plenty of hurdles along the way) :) .

I like that AZ has already responded to some of this negativity with a statement on their blog, showing that they are — at least — listening and responding:

AZ Health Connections: Pharma Blogs Face Unique Challenges
We are presented with some unique challenges  when it comes to mentioning specific products or disease states on our blog, but despite the critical headline, it’s also wrong for anyone to assume that this is how we want things to be… Can more be done to help provide accurate, balanced and timely information about our products, especially through social media channels? Yes, of course. But what the PharmaExec blog post labels as “close corporate scrutiny,” I see as responsibility.  While adding any extra level of “scrutiny” to the comments we receive may mean it will take longer for us to respond to a comment, this is how we will operate for now.

In the end, I leave you with a quote from my friend, Marc Monseau — the well respected editor of, which is probably the longest running and probably the most admired industry blog —  which I believe aptly sums up my thoughts on how this industry can move forward with social media… one step at a time:

JNJBTW: Healthcare Comapnies and theSocial Web (October, 2009)
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.

A Week (or 2) of Industry Launches: YouTube,Web 2.0, MedPedia, and Twitter…

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Over the last 2 weeks or so — including the time I was away at ePharma Summit — there were quite a few interesting launches and developments that I haven’t gotten around to blogging about yet, so in the spirit of catching up, I thought I’d summarize them here…

AZ and Sanofi Aventis launch YouTube channels


As mentioned in a previous post, YouTube seems to be the “channel of choice” (pardon the pun) when it comes to pharma adoption of new media. So I guess it should come as no surprise that two more big pharma’s launched YouTube Channels last week…

Firstly, AstraZeneca launched the My Asthma Story YouTube Channel, which complements it’s Symibcort-focused My Asthma Story Website and encourages people who have been “diagnosed with asthma, and prescribed SYMBICORT” to submit a video clip of their asthma story (see submission guidelines) — “Everyone with asthma has a story to tell. We’d like to hear yours“.

Also, Sanofi Aventis launched the Go Insulin YouTube Channel, to complement their Website, which features “insulin success stories” (video clips). Unlike AZ however, Sanofi doesn’t mention/promote any products on the page (just the company logo) and doesn’t asking for patient submissions at this time. Compared to the AZ site, Sanofi has also done a really nice job in designing the YouTube and websites – great visual appeal, IMHO.

The interesting thing about these two launches is that they both took a similar approach of using a traditional website to complement a YouTube channel and drive their audiences bi-directionally between the two; almost like the YouTube channel was just an extension of their video-filled website, but obviously with much greater mass appeal and reach. But what’s even more interesting to me is that (to my knowledge) MyAstmaStory is the first pharma YouTube channel to carry a product brand (Symbicort), which in my mind, indicates that pharma is getting more comfortable with this medium as a promotional channel, including their legal and regulatory teams.

With online video being the fastest growing medium for consumer consumption for several years in a row, and Google’s smart moves to enable YouTube channel administrators to control some of the “social features” (e.g. comments, embedding, etc.) , I’m not at all surprised to see more and more pharma companies jump on the YouTube bandwagon… In fact, I only expect to see more.

For more details on the two launches, read the EyeOnFDA Blog by Mark Senak, who stays abreast of health and pharma YouTube activities and even aggregates these health/pharma related YouTube videos on his own EyeOnFDA YouTube Channel.

Feds Also Adopting Social Media

Not to be outdone by all the pharma activity on YouTube, it looks like federal agencies — like HHS, CDC, FDA — are also starting to get on the new/social media train. Firstly, according to

The federal government is on the verge of reaching an agreement with YouTube that would allow agencies to make official use of the popular video-sharing service. A coalition of federal agencies led by the General Service Administration’s Office of Citizen Services has been negotiating… on new terms that would allow agencies to establish their own channels on the site.

For some interesting commentary on this, read this EyeOnFDA blog post — here’s a quote:

Adding YouTube to the communications menu of the federal government has a number of ramifications. First, one hopes that they do it right. CDC and FDA are examples of two agencies who are there, but their channels are irregular and the editorial framework is unclear. FDA, in particular, has a bunch of channels and it is difficult to know what will be posted where.

And if you think that’s as progressive as the Feds get, then think again… As it turns out, they’ve been involved with Web 2.0 and Social Media for a while now. For example, the HHS/CDC had a booth at the Podcast and New Media Expo in 2007, the CDC had an open discussion focusing on Social Networks, Blogs and other Web 2.0 Apps in 2008, and Miguel Goemz and Fred Smith from HHS even spoke at the 2008 New Media Expo about their use of Web 2.0 for (see interview at bottom of post here).

More recently however, it seems like the Feds have become even more active in the social media space, with the launch of a Twitter account for FDA recalls (@FDArecalls) and even an active Twitter representative in the form of Andrew P. Wilson (@AndrewPWilson), who is a “Member of HHS social media team” (according to his profile). Who knew the HHS had a social media team??? Anyway, despite all that, nothing could have prepared me for this… the Social Media Tools for Consumers and Partners – a webpage that describes all their scoial media activities, including blogs, email subscriptions, Health e-cards, mobile info, and online video. Wow!

For a great take on the whole Feds and social media thing, read Jonathan Richman‘s Dose of Digital blog post (and follow the links to previous stuff he’s written). He’s got great insight and commentary on the entire situation.

Medpedia Launches

Earlier this week, Medpedia — a new medical wiki — was launched with the support of its founding partners: Havard Medical School, Stanford Medical School, University of California Berkely School of Public Health, and University of Michigan Medical School. According to the website…

The Medpedia Project is a long-term, worldwide project to evolve a new model for sharing and advancing knowledge about health, medicine and the body among medical professionals and the general public. This model is founded on providing a free online technology platform that is collaborative, interdisciplinary and transparent. Read more about the model.

Users of the platform include physicians, consumers, medical and scientific journals, medical schools, research institutes, medical associations, hospitals, for-profit and non-profit organizations, expert patients, policy makers, students, non-professionals taking care of loved ones, individual medical professionals, scientists, etc.

If Wikipedia is any inidcation of how powerful and successful a well designed and maintained wiki can be, then I have to agree with Mark Senak’s post about the importance of Medpedia in the future, where it may become tops in organic Google search for medical and health related terms, just as we seem to see now with many Wikipedia definitions

The question is: Will the right people be engaged and willing enough to spend time “maintaining the Medpedia garden” in order for it to become the dominant medical/health reference of the future? Perhaps… I think it definitely stands a chance just looking at the number of Health Professional articles on Google’s Knol and videos on YouTube. Read EyeOnFDA’s report on this which also has a great audio interview with the founder and head of Medpedia, James Currier.

Pharma’s Tweeting…

Twitter has been growing like Jack’s beanstalk lately. In fact, it grew by 752% in 2008. So it’s probably no surprise that a lot of companies are also jumping on board, including pharma and biotech. Up till recently, the only two pharma’s I knew of that use Twitter as official communications channel are @novartis and @Boehringer. I also recently discovered that AstraZeneca (US) has a Twitter account (@AstraZenecaUS), though their udpates seem to be pretty sparse at the time of writing. In addition to all that, J&J also recently launched an official account, @JNJcomm, just last week. Previously, Marc Monseau (Editor of had a personal twitter account, so it was not an official channel.

While there’s not as much control on Twitter account settings as YouTube has for it’s channels, I can only imagine that more pharma companies are going to be jumping on board the Twitter-train sooner rather than later. How they use it to engage, on the other hand, is going to vary greatly from company to company. At the very least, I see companies setting up accounts as “listening posts”, but others may choose to engage, like @boehringer does in an informal manner. Whatever the case, Twitter is fast becoming the new dominant space for listening and/or engaging with the community.

Motrin Marketing Feels the Pain and the Power of Social Media

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If you haven’t heard about the HUGE #MotrinMoms furor that erupted this past weeekend, then you must not have seen the multitude of tweets, blogs, and YouTube videos that escalated and intensified throughout Sunday (NOV 16), culminating in the website going down by Sunday evening (“Network Error” message).

In brief, J&J/McNeil Consumer Healthcare rolled out an online video on the brand website for, which over course of a day, infuriated what appeared to be hundreds, if not thousands, of people. Here’s a video that was “inspired” by all the negative comments…


I’m not sure exactly when the offensive Motrin video was launched, but it was picked up on Sunday by some “mommy bloggers”, who then spread the word through Twitter and within hours, it spread far and wide enough to generate a HUGE negative response and viral backlash towards Motrin and J&J/McNeil — some even calling for a boycott of the brand. Although the website finally went down (or got pulled???) by Sunday evening, it was already too late, as the video was uploaded to YouTube for “permanent preservation” in the halls of infamy. You can also see screenshots of the ad on the Small Dots blog.

To be perfectly honest, I’m not a parent, so I probably didn’t take as much offense to the ad as many other folks did, but I can definitely see their point of view.

I watched the whole event transpire throughout Sunday and it was probably one of the most impressive examples of the power of social media that I have seen unfold in front of my eyes…

The key source of conversation and spread was Twitter, which then lead to an escalation of negative blog postings, and then YouTube video responses (and it continues to grow). You can see the aggregation of Twitter streams using the #MotrinMoms and/or #Motrin hashtags, which by the way, was getting tweets by the hundreds every few mintues.

On the positive side, it appears that the VP of Marketing at McNeil has made an effort to reach out and apologize to some bloggers, but the damage may already have been done. Mind you, this was on a Sunday evening, though it’s probably no surprise that they got wind of the situation, as the fervor built over the course of the day, including some emails from folks I know personally to folks at McNeil.

So what’s my take on all this?

Well, I think the key take away from all this is that this is a case where NOT engaging in social media may actually have caused more harm to the brand than if one had engaged in social media, particularly among the target audience. And to now try to engage an audience that has even threatened to boycott your product, means having to climb a “barrier of trust” the size of Everest (or greater, depending on how they choose to respond).

At the very least, one could have engaged the influentials within the target audience (i.e. key mommy bloggers) and ask their opinion of the ad before it gets released to the wild… After all, almost anyone operating in this space will know the importance of mommy bloggers these days. Perhaps market research was done, but one has to remember that in traditional market research, WE are the ones asking the questions and controlling the conversation.

A key question that I was asked by a thought leader in the social media business was: …why didn’t they understand the momblogger audience better before they launched the campaign? and to that, I had to respond that it could possibly be due to “traditional pharma marketing” thinking — the marketing team is sold on an idea by their ad agency and only sees/hears what the agency tells them. Not sure if this is the case, but obviously the current breath of the outrage seems to indicate that even a small amount of social engagement/ interaction regarding the ad may have hinted to what might ensue.

Not to judge anyone at McNeil or their ad agency (apparently, Taxi NYC), but I would have thought a J&J company — if anyone — would have “got it” more than others, as J&J already has blogs, a YouTube Channel, and more. However, it’s a good wake up call to remind us that even the most seemingly harmless and well-intentioned concepts can go awry very quickly. And in this socially engaged and hyper-connected world, a negative message can spread much further and faster than you could ever imagine… Welcome to the Groundswell!

NOTE: Just before posting this, I noticed that the Motrin website is back up again, with an apology note posted in place of the video. Here’s what it says…

UPDATE  (11/18): Kathy Widmer (VP, Marketing @ McNeil) has also posted a response to all this via the J&J blog, It is a good thing that they have already been engaging people through their blog and have offered a mea culpa response (they even start with “We hear you…“), as well as a solution for the future — a lesson that we all learned from JetBlue.

More Sources of Information/Updates

How Pharma Can Leverage Consumer Generated Media – Nielsen White Paper

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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.

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.

Can Pharma Make a Business Case for Social Media? (2008 Digital Pharma Presentaiton)

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For those of you who have been patiently waiting and requesting for the slides from my recent presentation at #DigPharma08, entitled “Can Pharma Make a Business Case for Social Media”, I am happy to tell you that I have finally uploaded them to Slideshare and embedded them below.
Can Pharma Make a Business Case for Social Media
View SlideShare presentation or Upload your own. (tags: #digpharma08 pharmer)

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.

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