The FDA recently issued draft guidelines that impact how pharma can communicate in social media, but leaves many in the industry underwhelmed.

The guidance addresses only off-label information. It doesn’t cover on-label promotions, which means the industry can continue to communicate using this channel.

These guidelines provide instructions for pharma on addressing unsolicited off-label questions presented within a public arena, like a forum or chat room.

What industry can do:
If a question about off-label use is stated in a public arena (i.e., within a social media forum), the company may publicly provide a response. This response should:

1. Convey that the question pertains to an unapproved use of the product, noting the approved indication and safety information, and
2. Include the contact information for medical affairs, and
3. Only link to the product’s package insert. Links to promotional websites or third-party websites are prohibited.

Lastly, the firm should record the person requesting information and any follow-up questions from the requestor.

Industry agrees that these guidelines shouldn’t prevent companies from getting involved in social media. As long as they act in the spirit of the law, communicating in social media shouldn’t be inhibited by the lack of more specific additional guidelines.

There is a parallel between Ralphie’s situation and the medical community. Some (not all) doctors and regulators believe that sharing medical knowledge and treatment information with patients is not in the best interest of the patient. At best, these physicians consider a patient’s personal medical research to be a waste of time. At worst, they think this information will be harmful to patients or reduce the stature of the medical professional.

But that’s where the parallels end. Unlike a BB gun, information and resources in the hands of patients can only help patients. Patients who research information and therapies may be told by their doctors “you’ll shoot your eye out,” but rest assured, the environment that fosters these interactions is slowly evolving.

The benefits of patient empowerment should challenge those in authority who currently do not value the patient role in medical care. Patients value physicians who work together with them in a partnership. The outcomes from these partnerships will eventually tilt the medical conversation so patients’ needs are better met.

And that leads to better outcomes for everyone involved.

From Compass, we wish you warm holiday gatherings, delicious Chinese turkeys, and for all of your holiday wishes to come true. See you in 2012!

A few companies have remained on Facebook and are committed to moderating comments. Pfizer has done a respectable job establishing parameters for comments; they don’t allow the mentioning of products, side effects, or being vulgar or “off topic.” (Pharma Facebook page owners still have the right to remove comments on a case-by-case basis.) They have also responded timely to posts, proving that pharma can interact with patients in a safe way.

Other examples of companies that have maintained their Facebook pages include:

• Sanofi-aventis U.S. Diabetes
• AstraZeneca U.S. Community Connections
• Changing Possibilities in Hemophilia (Novo Nordisk)

These are in addition to a disease page that has always allowed comments—Janssen’s (an ex-U.S. page) [link to Psoriasis 360. Crohn’s & Me, a UCB page that previously allowed comments, was removed recently, perhaps in a review of Facebook pages.

Other disease education/awareness pages sponsored by pharma have gone by the wayside, proving that for some, Facebook is not worth the commitment to moderate comments. Here are a few examples:

• Drive for COPD (Boehringer Ingelheim)
• ADHD Moms (J&J)
• Epilepsy Advocate (UCB)

The comment disabling policy does not impact branded pages or disease pages where there is only one FDA-approved treatment. An example can be found at the sparsely populated Lunesta Facebook page.

Only about one in seven patients will visit a brand site when researching health information.  While this may be a disheartening statistic to a brand manager, this shouldn’t be seen as a death knell for the brand site.  This represents a key missed opportunity for brand managers to interact with and support a captive patient and caregiver audience.  Shifting the approach of the brand site and evolving best practices are paramount to make brand sites relevant.

Research tells us the effort will pay off.  Patients and caregivers who visit brand sites are more likely to have unaided and aided awareness.  They are more likely to discuss treatments with their physician, mention the product and request it.   They are more likely, if already on treatment, to adhere to their medication.

Evolving the Brand Site

Making the site primarily an informational experience – not overly promotional experience – is the first step as patients have come to expect tools and lifestyle information – not just promotional content.  Providing valuable, relevant content is a key step in establishing, or re-establishing, credibility with your audience.

Leveraging the informational gap in the health care system is another way for brand sites to reengage audiences.  Patients report not getting the education they need from physicians – comprehensive information about disease management, follow-up, medication information and lifestyle tools.  This is a key opportunity, especially for patients with chronic illnesses where misinformation could limit adherence.

Changing the dialogue from one-way to two-way communication is an important mind shift that needs to take place.  Typically, the patient experience is one-way communication, not interacting with the pharma company or other patients.  This doesn’t have to be the case.  A good example of brand site that has started to explore this idea is www.ampyra.com.  The site provides a way for patients to recommend questions/resources that others may find helpful.  It does so without opening the company to receive adverse events or other information, thereby reducing risk.  While not revolutionary in approach, it provides a safe way for patients and caregivers to interact.

(The Facebook “like” button is also a tool where patients and caregivers to interact with the brand, outside of the brand site, but that will be covered in a separate post.)

Videos are an excellent channel to provide interactive content and a relatable patient story.  We are in a time where video is ubiquitous – having it on your brand site is becoming a “must-have” for audiences who’ve now come to expect it.  Seven out of 10 health searchers are interested in watching-related health videos online.  Nearly half of users report that online health videos are a top resource when searching for medical conditions and prescription drug information.

It also makes sense for your brand – video viewers are more motivated and active; 93% take action after viewing health information in video form.  Nearly 70% are more likely to conduct more research after watching health videos online.  (A tip for brand managers: keeping the video embedded on a page with related content is a quick win.) After watching a video, 60% speak with their doctor.

Understanding that the customer’s expectations of content has evolved is key to making brand sites more relevant for patients and caregivers.  We are moving in a direction where marketing is customer focused.  The feedback channels have vastly improved.

Observing through social media is a simple and essential step to learn from patients.  They are providing their opinions, unvarnished, about your brand.  Patients also identify key areas of unmet needs that your brand can satisfy, whether online or offline. Listening via social media is a great way to keep insights fresh.

Patients these days have choices.  The steps to having a relevant and up-to-date website are worth it to keep users engaged, fill the information gap and motivate patient behaviors.

For brands and markets with an active social community (Read: nearly all), a thorough social media analysis can provide vast information from all audiences from the casual observer to the defending brand advocate.  Patients and caregivers are communicating in blogs, commenting on articles, tweeting and participating in forums.  We can learn real-time feedback.  More importantly, it can provide real insights to business objectives.  So, why aren’t all pharma marketers listening?

• Cost (time and budget)
• Fear of social media
• They don’t know what they should or can

Looking for the “Why” and the “What’s Next”

Social media is by no means a replacement for traditional market research.  It should never replace a quantitative survey, or supplant a focus group.  It can, however, provide marketers with a solid foundation of knowledge of consumer needs, sentiment and opinion towards the disease and/or brand.  It should empower marketers to establish the information they’ve learned by using traditional market research to quickly validate hypotheses.  Thus, using more traditional market research to spend more time drilling down  (the “why”) and uncover new findings (the “what’s next”).   

Take, for example, a recent project supporting a global brand.  A thorough and detailed social media analysis informed us of the brand’s limitations (limited brand awareness against a well-entrenched competitor) and marketplace expectations (desire for greater efficacy).  Using this research, we developed a patient message platform to test in traditional market research and discovered results that most aligned with our initial assumptions, based on our social media research.  More importantly, we were able to spend more time covering the “why” – why patients and caregivers acted in particular what and what motivations were driving their behavior.

Social media observation should be a part of every brand’s activities.  For brand managers planning market research, social media is an essential tool to lay a solid foundation:

• Establish what questions need to be asked
• Determine information to validate
• Discover baseline patient and caregiver needs

Additionally, social media provides brand managers with information that may or may not be truthfully conveyed in a patient panel.  It is because participants are not being led by moderators or thinking about the expectations for responses that can make social media more revealing.  One of the products we support has a challenge in helping patients adhere to their treatment, where side effects can temporarily overcome symptom relief.  In this scenario, we have identified where patients drop-off in treatment.  We can provide specific indicators that predict if patients will stop taking their medication.  This information drives adherence programs and other relationship marketing initiatives.

Have you conducted a social media analysis of your brand?  Do you currently use social media chatter as the most informal method of market research?  If so, what have you found to be the pros and cons?

Recently the FDA has given a great deal of attention to video, and pharma companies are grappling with the best way to communicate through this medium within regulatory boundaries. DDMAC is focused on identifying videos that overstate benefits and minimize risks, with the most recent letter issued was on a patient video on Premarin.com. According to the letter, the video overstated efficacy of Premarin by suggesting that it would eliminate all hot flashes and other symptoms associated with menopause. Additionally, it minimized side effects – available on the website only in text, under the video player.

Similar circumstances led to warning letters for brands such as Eisai’s Gliadel, which included voiceover of the risk information, but lacked prominence. A video on Herceptin had a different, but no more successful approach. Risks were presented in text only prior to the start of the video, and very little risk information was integrated into the video. Patients noted “mild fatigue” and “joint pain,” hardly a thorough discussion on risk that should accompany a product with a boxed warning.

Where to Go From Here

Benefits of a product discussed in a video should be on-label, of course, when delivered by any spokesperson. Thorough preparation, detailed screening and a highly trained interviewer can go a long way in eliciting responses that are natural, yet appropriate from the FDA’s perspective. Capturing physician footage to accompany the patient story is a best practice, particularly as physicians will cover side effects more comfortably and naturally.

Online videos should follow the same approach as contemporary DTC commercials. Safety/side effects/risk information should be integrated into the content of the video itself. It should be part of the story narrative, not a before or after thought like the videos cited above.

Further, “balance” should be as consumer friendly and natural as the discussion of benefits. Accompanying any contextual balance should be the full ISI, integrated in the video itself as well as on the page. The ISI should not be minimized by distracting visuals and other competing elements.

Planning for Success

Planning for video success begins sooner than the editing suite. With proper planning and expertise the integration of risk information within video is an achievable best practice that will increase credibility, drive understanding/comprehension and share risk information in a digestible format. And make FDA happy.

With viewers “tuning in” to watch video online, the consumption of broadcast content will continue to morph dramatically. Pepsi opted to skip advertising in the the most widely-viewed sports events to focus on social media efforts. Soon, Hulu could become more of a threat to traditional television than DVRs. Some companies continue to use long-form video, such as GlaxoSmithKline and the Alli-themed documentary, but brief, serial clips may yield an advantage for continued engagement.

In pharma, the opportunity is yet to be fully seized. Nearly half of online physicians in Western Europe reported watching Web videos for professional purposes. At the FDA social media hearing, we learned physicians watched instructional videos online the night before performing an orthopedic surgical procedure. And this doesn’t change translating from professionals to consumers. Video can be extremely effective in communicating with patients and caregivers beyond simple text. Video can communicate complex ideas, such as mechanism of action, more easily than the written word. Patients telling their own stories in their own words yields greater emotional engagement. And, very often it becomes viral.

This should encourage brand managers to recognize the unique benefits of video and leverage these assets online – whether on corporate, unbranded or products sites, or shared on social media channels.