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As many of you know, we are fast approaching SXSW Interactive. As I’ve mentioned in an earlier post, we will have our 5th Annual PreCommerce Summit on the Thursday before SXSW (March 12). Leading up to that event, I’ve asked a number of our speakers to do brief Q&A blog posts. The questions vary depending on the speaker but you will start to see a common theme emerge.

Scheduled contributors include:

There will be several others that we add to the mix but as you can see, we will work hard to make your brain hurt leading up to our events.

If there are any of our speakers in particular that you would like to see an interview with, just let me know in the comments section or tweet me at @aaronstrout.

Rare Disease Day 2015

As a W2O company, BrewLife undoubtedly has adopted the commitment to a true network of care, healthcare that is. While we certainly serve a breadth of clients, we pride ourselves on supporting the biotechnology, pharmaceutical and medical device industries. It is these industries and our clients that make days like February 28, 2015 all the more special. To many it is just another day, but to us, Rare Disease Day® is an opportunity to show our solidarity and support to the network we directly effect.

Rare Disease Day raises awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives. Launched by EURORDIS and its Council of National Alliances in 2008, the campaign has become a progressive phenomenon recognized by as many as 84 countries.

Rare Disease Day LogoJoin us and become a friend of Rare Disease Day by completing the form here and utilizing your social channels and/or website to raise awareness. There are no costs involved, just your time and effort. #MakeItHappen by using the hashtag #RareDisease and take a look at three ways you can get involved:

  1. Post Your Event – Whether you’re an individual or an organization viewing this post you can get involved. Post your event using this form on the Rare Disease Day official website.
  2. Raise and Join Hands – This symbolic gesture can be done before the Day or on it to show solidarity with rare disease patients around the world. Record the action and upload it to the Rare Disease Day website here.
  3. Tell Your Story – Whether you are living with rare disease or caring for a loved one or friend who has one, we want to know your story. Upload a photo, video or written story here.

Pledge your support and make your mark on Rare Disease Day, February 28, 2015. For more information, visit www.rarediseaseday.org. Together we can put rare diseases in the spotlight!

Trending Healthcare News

Concluding another successful year, the 2015 JP Morgan Healthcare Conference has seen its share of announcements, discoveries and unveiling of things to come. Following is a look at some highlights as the conference comes to an end:

–        Bloomberg reported that Pfizer is nixing efforts to get its experimental drugs approved for melanoma, instead focusing its attention on drugs that use the immune system to fight tumors.

–        FierceBiotech compiled a target list of ripe biotechnology companies primed for a merger or acquisition in 2015.

–        Jim Cramer of CNBC’s Mad Money spoke with Halozyme CEO Dr. Helen Torley about the company’s efforts in pancreatic cancer and partnerships the company has forged with Big Pharma.

–        Roche announced that it is partnering with genome pioneer J. Craig Venter in a multi-year deal to sequence and analyze tens of thousands of genomes for the company’s Genentech unit with the goal of identifying new drug targets and biomarkers.

–        The Wall Street Journal reported that NIH Director Dr. Francis Collins expressed concern that U.S. funding in innovation is on a dangerous downward trajectory and, if continued, may erode U.S. leadership in drug development.

 

After four days of the conference, we’ve seen more than 14,000 tweets using #JPM15. TG Therapeutics’ and Bluebird Bio topped the cashtag counts on Wednesday and Thursday, producing 46 tweets each with their cashtags $TGTX and $BLUE.

Some of the most retweeted tweets included:

The shared sentiment of JPMorgan attendees as summarized by John Carroll of FierceBiotech…

JPM15_FierceBiotech_Tweet

Link to full story: http://bit.ly/1C4Vwvh

 

 

 

 

Pharma execs’ thoughts on how and what technologies will be instrumental in transforming medicine via Meg Tirrell…

JPM15_MegTirell_Tweet

 

 

 

 

 

 

 

 

 

TheStreet columnist Adam Feuerstein’s light humor…

JPM15_AdamFeuerstein_Tweet

JP Morgan Healthcare Conference Logo

It has been only two days at the J.P. Morgan Healthcare Conference, yet so much has already happened! Here is a look at some of the highlights to date:

– In an exclusive interview today on the FOX Business Network, J.P. Morgan Chase Chief Executive Jamie Dimon said the U.S. economy will continue to improve after the Federal Reserve hikes interest rates.
– Shire acquired U.S. biotech NPS Pharmaceuticals for $5.2 billion.
– The Wall Street Journal reported that Genomic Health Inc. plans to develop a line of liquid biopsy tests that can detect genetic evidence of cancer in a vial of blood.
– Medical Devices & Diagnostic Industry emphasized the growing importance of partnership in the shift to value-based healthcare.
– Bloomberg reported that 2015 would be the “pivot point” for oncology and immunotherapy with promising results coming from trials by Merck & Co. and Bristol-Myers.
– Reuters reported that the FDA approved Duopa, AbbVie Inc’s treatment for Parkinson’s disease, which works four times longer than current treatments.

After two days of the conference, we saw more than 8,500 tweets using #jpm15. BioMarin’s presentation topped the hashtag count on Monday, producing 66 tweets with its cashtag $BMRN.Runners up included Sarepta Therapeutics, BlueBird Bio, Clovis and Merck.

Some of the most retweeted tweets included:
Genentech’s comments on partnership…

Genentch tweet

 

https://t.co/uKYLWiK9BD

 

 

 

 

Lisa Jarvis, biotech and pharma reporter for Chemical and Engineering News…

Jarvis tweet

 

 

 

More news to come as the conference continues!

 

Missing the forest for the trees

This is a question that we healthcare communicators have been fielding from clients (and, frankly, discussing among ourselves) since the advent of social media as we try to engage with healthcare professionals.

Some have maintained that physicians’ level of tech-savvy rivals the quality of their handwriting – not so great. Forced to be connected only by the mandate of electronic health records, physicians aren’t active online due to packed appointment schedules, privacy concerns or the desire to remain unbiased as related to their health system or practice.

A new report by my colleague Greg Matthews, called “Missing the Forest For the Trees”, lays this old stereotype to bed. According to a 2012 study by the Journal of Medical Internet Research, cited by Matthews, 61% of physicians scan social media for medical information weekly, while another 46% contribute to that information on a weekly basis. In addition, online social channels are having an impact on clinical decisions – according to a Manhattan Research study also cited in the book, 39% of doctors say that the information they receive from social channels is influential to very influential on their clinical decisions.

I don’t want to give away too much of “Missing the Forest For the Trees” – it’s a quick, worthwhile read – but all these stats point to our need, as healthcare companies and communicators, to be online learning from and engaging with doctors. Physician-directed content strategy for platforms such as Twitter and LinkedIn, will be seen by physicians, and sponsored ads make it easier than ever to target the right ones. Matthews makes another critical point – there is a tremendous opportunity for companies to harness the power of online physician advocates, engaging them to spread the word about our therapy, device or awareness building effort. Physicians are our “citizen” journalists.

Matthews has led the development of MDigitalLife, a database that has indexed the digital footprints of nearly a half-million physicians around the world. This data can be harnessed by healthcare companies in a myriad of ways including influencer identification and conversation analysis. MDigitalLife is also a great source for research about physician online activity with a treasure trove of free resources on its website.

Social media is not new, but this way of thinking about physicians on social media is, and healthcare companies who engage physicians through social media very well may find a new partner in spreading the word.

For a free copy of “Missing the Forest For the Trees” please visit http://bit.ly/missingtheforest. And, to learn more about MDigitalLife, go to MDigitalLife.com.

Idenix discovers and develops drugs for the treatment of human viral diseases. BrewLife worked with Idenix over the past 6 months to energize the company’s brand as it pushes forward with the clinical development of its HCV drug therapy. This included braving a Boston snowstorm to conduct a brand workshop in mid-December, developing strategic positioning, a new logo, refreshed corporate identity, creative campaign, a new website and their annual report.

Idenix logoThe “X” in the logo Trevor designed with the orange diamond in the center was designed to reflect the targeted nature of the company’s drug delivery capabilities and was then used as an iconic graphic design element across the identity system and all marketing materials.

Idenix Annual Report We officially debuted the brand with the launch of the website in April. A mere two months later, Merck decided to acquire Idenix with the transaction expected to be completed later this month. Coincidence? We think not.

Today we received a package of Idenix goodies, including the annual report and lots of fun schwag. Margot and Ben showed some of it off for the camera before all-out Frisbee war erupted.

In the five years since the open public meeting on social media, the FDA has occasionally shared their thinking via letters and draft guidance. They provided more clarity on June 17, 2014 by simultaneously issuing draft guidance on two separate topics: “Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”

It’s important to note that both refer specifically to prescription drugs (human and animal) and medical devices. Let’s start with the first document, which I’m nicknaming “The Twitter/Paid Search Guidance.”

TWITTER/PAID SEARCH GUIDANCE SUMMARY

The draft guidance recommends how to include risk/benefit information on sp ecific channels with character limits (e.g. Twitter and paid search).

No matter what the space limitations, companies must post both the benefits and main risks associated with a product within the same message or tweet, with a hyperlink taking the reader directly to a more detailed list of risks (and not simply the homepage of the promotional site). They provide specific examples that include the use of URL shorteners, as well as common and scientific abbreviations. For paid search media advertising (e.g. Google and Yahoo!), this guidance outlines how companies can make use of multiple links within each ad to satisfy fair balance requirements.

Takeaways

  • Clear direction on how branded promotional tweets and paid search advertisements are possible.
  • Stresses that for products with complex indications or serious risks, it may not be appropriate to use digital platforms that have character limitations as a communications vehicle.
  • Other social media platforms with longer form textual opportunities are not in scope of this guidance; until further clarification, standard FDA promotional guidelines would still apply.

This FDA draft guidance offers new possibilities for brands.

Key actions

1)      Evaluate paid search advertising campaigns: Review any current brand promotional ads utilizing vanity URLs that redirect to the brand site. Consider creating new branded, promotional ads based on this guidance. We recommend performing tests to compare which type of paid search brand ads are more effective.  This draft guidance provides new options for promotional Paid Search ads that may prove valuable for brands—although it will need thorough testing to determine success.

2)      Consider if Twitter is right for the brand: In some cases, branded promotional Twitter accounts may support the brand goals. However, after the benefit/risk information and link to risk is included in a tweet there will be very few remaining characters left for additional messages or links. These instructions will likely make it very difficult for a brand to implement in practice. Reminder ads can still be used. In addition, the severity and complexity of the product or device (and the length of the brand/established names) may preclude the channel. Moving forward, it will be interesting to see how many brands are willing and able to utilize Twitter as a promotional vehicle.

CORRECTING MISINFORMATION GUIDANCE SUMMARY

The draft guidance recommends how companies may choose to correct misinformation (both positive and negative) related to their own product.

The FDA focus on “misinformation” defined as: Positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular.

Firms may choose to correct misinformation. This still holds true if the misinformation occurs in the context of User Generated Content (UGC), regardless of whether the firm owns or operates the platform (or not) on which the communication appears.

The corrective information does not need the full balancing of risks and benefits that are normally required, as long as the following criteria are met: be relevant/responsive, limited and tailored to misinformation, non-promotional in nature/tone, accurate, consistent with FDA label, be supported by data, post in the same area as the misinformation and provide full disclosure that the poster is affiliated with the company. A subtle (but important) recommendation is that a firm may choose to provide contact information, giving the example of the company’s Medical Affairs Department.  A strong suggestion that the corrective information has FDA-required labeling included or provided in a readily accessible format (e.g. PDF).

Companies do not have to correct each piece of misinformation in an entire forum, but should clearly identify what misinformation is being corrected, with as much specificity as possible. However, do not cherry pick and leave other more “positive” misinformation.

Also, in the unlikely case that a reportable Adverse Event is seen, follow the normal process.

Outside of scope:

  • Once the company corrects misinformation, company is not expected to continue to monitor.
  • If a company asks an author to correct misinformation, the company is not responsible if this does not occur.
  • A company does not need to submit corrective info to FDA, but should keep detailed records of all corrections and interactions.

Takeaways: 

  • Companies can correct fully independent third-party online misinformation without specifically exerting the full scope of fair balance.
  • Given limited resources of companies and the disparate levels of impact of different online platforms, it will be important to prioritize the platforms/forums before addressing misinformation (e.g. prioritize according to reach and relevance)

Key actions

1)      Analyze the popular online third-party information on your brand: If you don’t know already, determine where there is misinformation and how egregious it is. Then rate the sites for reach and relevance to your target audiences. This will help you analyze whether it is worth correcting misinformation and, if so, prioritize the sites. For example, if Wikipedia has misinformation on your product page, this would be worth the effort to correct as Wikipedia is an extremely popular destination for both HCPs and patients. We can provide the analytics data and work with clients to ethically and appropriately share information with Wikipedia.

2)      Ensure clear internal guidelines around how to correct misinformation:  Review current employee guidelines to ensure that they specifically address the issue. Make sure these include very clear instructions for employees about what to do if they come across misinformation (e.g. forward to Communications team); ensure there is clarity about who is allowed to make changes (e.g. Medical Affairs team) and how they must do it (e.g. full disclosure and requires approval). Roll out revised guidelines (and relevant training) in targeted manner to make sure all affected stakeholders (including partners/agencies) are aware and aligned.

3)      Education and training: In light of the guidance and the ever evolving landscape of digital communications, it will be critical to educate employees (and external partners, agencies, etc.) and ensure that they understand these documents and know explicitly how to proceed should they find misinformation.

Next Steps

Talk to your medical, legal and regulatory teams: Have a discussion around these new guidelines to learn their point of view. This is the POV that counts the most. We are available to help clients with this discussion.

Listening and analytics: It remains extremely important to have a finger on the pulse of the ongoing conversation around healthcare and social media. Monitoring brands online and the dialogue around them will help shed light on what is currently being discussed and how people are engaging—or hope to engage—with brands.

We understand that many questions still remain as the FDA will continue to evolve their recommendations, and we look forward to working with our clients to explore these new opportunities.

While my name is on this blog post as author, the thinking behind it came from a team of people including Colin Foster, Erin Bittner and Carissa O’Brien. One final note: I do commend the FDA for releasing this 3 weeks before the July 9 deadline – I was expecting it on July 3rd!

Patients are the #1 reason I’m passionate about my job. Listening to and being given the honor to share their stories of perseverance, strength and courage provides me daily inspiration, and collaborating with my clients who are fiercely focused on improving lives is both intellectually stimulating and emotionally satisfying. That’s why I think today is such an important day.

Today, February 28, is Rare Disease Day! The National Organization for Rare Disorders (NORD) and its supporters have again organized a Goliath-style day of awareness for the millions of patients and their families who alone are facing rare and often unknown diseases, but who together are strong. 

In support of NORD’s mission to help elevate rare diseases into the public spotlight as a global public health concern, I encourage you to share this blog and all of the great content NORD has created.

 NORD-Who-Does-Rare-Disease-Affect_DRAFT-2.19.14-e1393025442778

Our W2O Group hosted a webinar today (full link at bottom of this post) featuring a panel of our regulatory, corporate communications and social media experts to discuss an overview and potential implications of the FDA’s long-awaited draft social media guidance. Hopefully, this is the first step toward having more comprehensive guidelines to help pharma navigate the rules of the road for social media. To date, given the lack of definitive guidance, we have had to rely primarily on warning letters and employ common sense to help us cautiously steer the course and build engagement.

The FDA has described this guidance as pertaining to “Interactive Promotional Media” that aim to help healthcare companies determine if electronic communications using social technologies are subject to FDA’s post-marketing submission requirements. This is most impactful for branded, promotional communications.

Key Takeaways:
1. Be accountable for YOUR content
: This means not only content that your company produces, but also covers content generated by employees, agencies, KOLs, brand ambassadors, contracted sales reps, etc.


FDA_Guidance_Cover2.
The guidance gives brands more clarity on what is and isn’t within FDA’s promotional jurisdiction: For example, if a company provides only financial support, but doesn’t control or influence content, the company is not responsible for what goes there. However, companies still must share anything that they submit to a third-party if it’s posted on digital platform.

3. User generated content (UGC) is primarily the user’s responsibility: The guidelines also take pains to clarify a company’s responsibility toward content from independent third parties — even if it happens on a brand’s own Facebook page, blog or forum. A company generally is not responsible for UGC content, and FDA won’t ordinarily view UGC on company-owned or company-controlled venues such as blogs, message boards and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the company and the company had no influence on the UGC. 

4. Brands can (cautiously) practice real-time social media: When brands engage online, they don’t have to submit content for FDA review before it is disseminated through their channels. This further opens up the opportunity for brands to do real-time engagement (e.g. respond to Facebook posts, comment on a blog). The FDA makes it clear, however, that companies must collate all content they have developed and submit for review on a monthly basis.

5. So, what does this mean for your company’s social media properties? Our guidance is that, for now, we should continue running social media properties with a “business as usual” attitude, which is rigorous and vigilant in terms of review process, particularly with ambassadors, KOLs or other partners.

More definitive guidelines from the FDA are expected in July, but FDA has historically had shifting timelines, particularly around social media guidance.

One question that’s still outstanding is what will be necessary from a safety standpoint/fair balance in branded social media posts, especially when using a platform like Twitter that limits you from including that safety information. According to John Mack of Pharma Marketing Blog, this guidance is expected later this year. 

Webinar_screenFDA Social Media Draft Guidelines Webinar: Friday, January 24, 2014
https://w2ogroup.webex.com/w2ogroup/lsr.phpAT=pb&SP=MC&rID=40406592&rKey=8997212f3ded6151