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Last week, I and a few hundred other SM-aniacs, spent  2-days in the #FDASM [1] 'bunker' [1] http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm

By Ellen Hoenig Carlson on Nov 16, 2009

Last week, I and a few hundred other SM-aniacs, spent  2-days in the #FDASM 'bunker'

-so nick-named for its lack of windows and web/cell phone coverage. (Many more also attended via a free webcast and live twitter.)  

Shortly after the program began, I heard a faint voice in the back of my mind. At first I couldn't place the voice or make out the words.  But it grew louder with each presentation. On the train home, I recognized the voice as JFK's, and the words as his inaugural speech "Ask Not What Your Country Can Do".

If you haven't read JFK's short but powerful speech, do yourself a favor and read now.  I think you may be struck by the parallels between the challenges he faced and the vision he articulated to meet them, and the challenges we must rise to as pharmaceutical and social media professionals trying to keep up with empowered e-patients in a web 2.0 world, soon to be web 3.0.   

Here are some of the challenges JFK articulated in his speech that seem particularly relevant to our challenges of engaging and educating patients and doctors using rapidly evolving technologies and strategies. I'll also do my best to link back to the many speakers and presentations from #fdasm.

"The world is very different now..."

• Fact after fact, presentation after presentation, reinforced the exponential growth of the web as a critical information source for healthcare education and community building...Some of my favorite factoids:
  
  
  
  • Google pointed out that during just the last 3 months of 2007 there were 4.6 billion searches using healthcare terms made by 111 million people and that healthcare searches are growing exponentially. They also provided examples of how access to information on the Internet can be a public health plus (Read Senak's eyeonfda blog)
  
  
  • Pew's survey reports that 61% of Americans look online for health information-these are the e-Patients of today. And 37% of adults- or 60% of e-patients- have accessed user-generated health information.
  
  
  • Manhattan Research: 35% of adults use social media for medical information which equates to 80 million health 2.0 consumers. Mark Bard also presented data on physician web 2.0 use
  
  
  • In addition to the sheer volume of online health activity, consumers are searching and interacting with one another in highly specific targeted ways. For example, Health Central's quick review of various social media sources last month, found: there are more than 100,000 people on Facebook diabetes groups, there were recently nearly 500 posts on ADHD in a 24- hour period on Twitter, and more than 201,000 searches on "Concerta" in September on Google, more than 40,500 searches for "Cymbalta side effects" in September on Google etc
  
  
  • However, I hope this means that Pharma can now put all the 'web selling' and 'can you top this fact' finding behind us in favor of identifying and exploring solutions to more effectively engage web 2.0 platforms.


• Web 2.0 and social media platforms have engendered new consumer expectations. 'Selling' is not always welcome in the web 2.0 and 3.0 world. Patients are looking for value-added knowledge- when and howthey want it-notwhen and how the pharma co. (or FDA)wants topresentit. To many e-Patients, selling clearly comes after information and value exchange, but pharmacos should be part of the conversations. Jack Barrette of WEGO Health presented survey data from their patient advocates to this effect. (Q1,2, 3, Q5) (I also suggest reading Patient DC's blog for another e-patient perspective.) Interestingly, physicians also demand a different voice and engagement when they are using social media sites, as presented by both Sermo and Pfizer's Freda Lewis-Hall.


• New information sources, including wikipedia, blogs, chat rooms, and sites like WEGO are establishing new influencers and thought leaders that Pharma and FDA need to consider and engage. However, while Wikipedia is a vastsource of information for consumers, its contentis not 'controlled' by FDA or pharma. Nor are the many e-patient/caregiver blogs and community sites. This means that user generated content (UGC) is inconsistent at best and often incorrect or biased. Importantly, however, the patient advocates at WEGO Health reported that they expect pharma to make their best effort' to monitor and correct incorrect or biased' third party UGC and to monitor adverse events, despite their rational knowledge that monitoring the entire web is impossible.

"But neither can two great and powerful groups take comfort from our present course - both sides overburdened..."

• Neither Pharma/device marketers or the FDA can move forward without developing guidelines or 'guard rails' to enable faster and more effective uptake of social media platforms and tools. (Michele Sharp of Lilly) However, many speakers, including Liz Forminard and Philomena McArthurx at J&J made the case that guidelines must remain flexible. (Read Marc Monseau's blog at JNJBTW)


• Moreover, current communications are often burdened with so much technical and legal language that the average consumer cannot understand or be sufficiently motivated to make the effort to read and comprehend risk and safety information. Cadient highlighted the fact that 30 million Americans are health illiterate. Research has shown that education levels required to understand and comprehend the average ISI and PI is some college education and post-graduate education, respectively.


• This is a case where more is not necessarily better'. More work is clearly needed to "radically simplify" risk language so that it's more consumer friendly, and to better educate the public for the need to report adverse events. Many speakers recommended the urgent need for new and simplified consumer risk language, and/or an easy to use FDA approved' patient symbol to signal quality accurate content, and/or an easier to use and more patient-friendly MedWatch initiative to insure higher levels of AE reporting, including PhRMA, Fard Johnmar, Wendy Blackburn RxRisk icon, Jonathan Richmond, John Mack, Bill Drummy, and Dr. Diana Zuckerman of the National Research Center for Women and Families. (You may also want to read my summary and presentation from the prior FDA Patient Risk Communications Advisory Meeting earlier this year.)

"So let us begin anew - remembering on both sides that civility is not a sign of weakness, and sincerity (and transparency) is always subject to proof. Let us never negotiate out of fear. (Or worse yet, adopt a strategy of avoidance out of fear) But let us never fear to negotiate."

• Transparency and the establishment of guidelines are needed to stop pharma from avoiding social media platforms out of fear of FDA. (Lilly, Global Prairie, J&J, Pfizer)


• Many expressed that the internet is a complex and different medium than TV and Print, and likewise requires unique adequate provision policy similar to how FDA approached DTC TV advertising back in 1997. Given the many different platforms and roles that the web plays, from search to advertising to 2-way interactions and UGC, specific web 2.0 guidelines need to be created and continuously updated. While for the most part, the message must stay the course across different media, there seemed to be recognition that the web's uniqueness requires some new thought and guidelines.


• New ways of looking at benefit and risk tradeoffs are required if we are to support and educate the consumer. Digitas presented research that showed that more risk information does not always result in greater risk comprehension if less consumers read it.


• On the accountability front, Oglivy 360 Digital Influence presented their 3 C's approach to help guide responsible marketing in the web 2.0 age: creation, collaboration and compensation. If the answer is yes to any of these three C's, then the pharmaco is responsible for its content.

"Let both sides explore what problems unite us instead of belaboring those problems which divide us"...

• We need to design ways to put the patient first. Both Google, Ignite Health and Intouch Solutions presented data that showed that the drop in paid search advertising has meant a huge drop in patient searches or click-thrus to higher quality FDA approved pharma.com sites and more...So while on the surface, the 14 letters may have seemed like a prudent idea, the result may be actually something less than preferred with less scrupulous and lower quality content filling the void.


• While FDA and pharmacos may differ on how they might approach the balance of benefit and risk information, they can unite behind the need to "radically" change the way that risk/benefit information is presented to improve comprehension, to provide consumers with a way to better know that risk information they are reading is accurate (many consumers don't check the source), and to encourage consumers to report AE's-as very few are ever reported.

Let both sides seek to invoke the wonders of science instead of its terrors. Together let us explore...

• There was much recognition for the continuous exploration of how to best conquer the fast evolving technology to help educate and instill more responsibility for patient health. Many speakers recommended that on-going committees be formed...


• Great quote by Peter Pitts, Center for Medicine for the Public Interest, "Social media is too important to hide in a cave. It is communication at THE speed of life." (via Roska Digital)


• Wrapping up the two-days, Tom Abrams, Presiding officer for the FDA hearing, reinforced not only the importance of the web to current and future healthcare policy, but that its complexity requires a very thoughtful exploration by FDA. (Watch Pixel and Pills exclusive interview with Thomas Abrams at the conclusion of the advisory meeting.)

And so, my fellow Pharma and Healthcare Marketers:

Ask not what Social Media can do for you - ask what your Social Media can do for patients... Ask what together we can do for the improvement of patient health...     

e-Patients of the world, ask of us the same high standards of strength and sacrifice, education and responsibility, which we ask of you...

Thoughts? Comments? Feedback?  While no meeting can solve the problems of the world, all and all, I think it was an excellent start. My sincere appreciation to all the presenters.

There are also many terrific blogs and summaries on the 2-day FDA Advisory Meeting: Shwen's Live from DC extensive list of #fdasm blogs, Pixels & Pills EXCLUSIVE Interview with Thomas Abrams at the FDA Hearing and others (Rohit Bhargava of Ogilvy PR 360, Peter Pitts, Jack Barrette of WEGO Health), A Patient Perspective by DCPatient,  John Mack, Mark Senak's EyeOnFDA, Roska Digital's numerous updates, and  Chris Truelove's wrap-up which also includes some good links-Yet more blogs and speaker presentations can be found at Fabio Gratton's fdasm.com. And for a list of good blogs leading up to the meeting, read my post: Twas the night before #fdasm.