What made January extraordinary for drugmakers was not merely the speed with which the FDA acted (at least two were approved well ahead of the agency’s deadlines), but the fact that the highest-profile of the major approvals came in so-called orphan diseases, which affect less than 200,000 patients and can afford developers additional market exclusivity.

The trend of serving smaller patient populations with more targeted drugs is almost certainly going to increase, thanks to better technology and an better-understood business model for serving smaller groups. The best evidence for this the number of drugs for which orphan designation was granted. For years, this number hovered in the double-digits. Then, in 2004, 133 drugs were given orphan status. Last year, 199 made the cut. If the trend holds, we’ll top 200 in 2012. (See chart.)

And this is a leading indicator: many of these drugs are years from getting an FDA nod. But the number of approvals is rising, too. A record number of orphan indications — 26 — got FDA approval last year, and it’s not a stretch to think that that number will rise, too.

The race to explore orphan indications marks a fundamental shift in the way breakthrough therapies are introduced. The number of drugs that are aimed at populations of millions and millions are shrinking. And while we won’t see the end of primary-care-driven blockbusters, they will certainly become more rare. That’s going to mean a move for those in communication to get closer to the smaller patient and provider populations: less flashy celebs, fewer DTC ads, more emphasis on trade publications and narrow online communities.

It’s always dangerous to make large conclusions out of a few data points. Regression to the mean means that it will get cold again. And the FDA isn’t likely to have many weeks where they sign off on three new drugs. But the surging number of orphan designations means that — over the long term — the orphan drug climate is likely to stay hot, no matter what the groundhog says.

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“Twitter is like a cocktail party … you don’t just want to talk about medical things all the time.”

- Dr. Jennifer Dyer

Dr. Jennifer Dyer loves working with kids – and she maintains a childlike curiosity and passion for learning in everything she does.  All it takes is one look at her twitter profile – @endogoddess – to know that she’s no stuffed-shirt, dull clinician.  At any given time, you might see tweets about fashion, food, New York – or yes, health and medicine.  Trained as a pediatric endocrinologist at the University of Texas – San Antonio, she always just found the kids to be more “fun and funny” to be around.  She has always been motivated by getting to know her patients well, and building a truly personal relationship with them.  And she’s found that maintaining a basis of fun, funny and factual is the key to good health information and healthy practices.

After medical school, Jen moved to Columbus, Ohio to take a combined clinical and research role with the Ohio State University (she says it more like, “THE Ohio State University”).  While at OSU, she had a chance to work on a Masters program in Public Health, and it was a revelation to her.  She found that she was able to understand the healthcare system from a completely different perspective – and realized how important it was for doctors to be able to understand the context that wraps around every doctor-patient relationship.  She also found that she was able to exercise her creativity in ways that she hadn’t been able to do in a traditional clinical/research setting.

It was also during her MPH coursework that she began to dive deep into the concept of health literacy, and to understand how critical it was to develop deeper health literacy in the US.  Jen, like many other doctors, was beginning to realize that her patients wanted and needed more access to quality information.  They were willing to search and conduct their own (primarily online) research, but it was hard to find information that was really trustworthy.

In the course of conducting a study on health literacy in early 2009, Jen went to a conference in Santa Fe, NM – a conference that was focused on healthcare communications, and the then-new phenomenon of social media.  At that conference, she ran into an old Texas acquaintance, Dr. Bryan Vartabedian.  He was talking about the ways that physicians could use twitter to connect more effectively with each other and with their patients.  As a born explorer, Jen signed up on the spot.  She was able to grasp its potential immediately – but also feared that using it effectively could be a significant time drain.  In order to stay motivated, she’d need for her twitter account to be about more than just clinical medicine.  And thus, @endogoddess was born.  Her twitter account, even three years later, is a perfect mix of her personal and professional interests – though rarely if ever a vehicle to convey personal/private information.

“My mission is to provide patients with evidence-based, medical facts.  That’s what people ask of me and expect from me – and it’s something that every doctor can provide.”

Dr. Jennifer Dyer

 

The more connected Jen became, the more she felt she was able to help her patients.  She became incredibly tuned-in to health-related programs in Columbus, and was able to use her presence in social media (in addition to her practice) to share that information with the people who’d benefit from it.  She’s found twitter to be a great place to communicate with that broader health audience – people who are interested, broadly speaking in learning more about diabetes, pediatrics and endocrinology.  Like most doctors, she’s regularly pinged by her friends and family about medical questions – the kind of data, information and insights they were having trouble finding on their own.  Armed with that solid understanding of her audience’s needs, she’s been able to provide content online that links her audience with the information they need.  Twitter allows her to do that with an audience that includes – but extends well beyond – that core group of family and friends.  And she has a rule – whenever she’s asked a question on twitter, she responds.  That response often points people either to an existing online resource, or encourages a dialog with their physician (it never strays into sharing private information or medical advice per se) – but the point is that she always responds.

She was quick to point out that, if she met someone in the supermarket who asked whether they should be taking aspirin or tylenol, she couldn’t possibly answer that question.  She doesn’t know them, their medical history or their needs.  But she can often help that person to ask the right questions of their personal physician so they can find the answer to their question.  And twitter works in pretty much the same way.

The last year has been marked by some pretty radical changes in Jen’s professional life.  Through the course of another study at OSU, Jen was really interested in how she might be able to use digital and social media to stay connected with patients – particularly diabetes patients for whom treatment adherence has especially important consequences – between appointments.  Her study was beautifully simple.  She created an SMS-based communication protocol with her patients.  Over a three-month period, she would text-message a group of patients on a weekly basis.  The nature of the communication was as follows:

- standard greeting

- personal question based on their individual relationship (e.g., an icebreaker that re-establishes Jen as someone whom they know and trust)

- a quick question or two about their proactive diabetes management and their results. “How are your sugars?”  “How often are you testing?”

This simple approach resulted in measurable improvements in patient outcomes – and led to her drawing significant attention both locally and nationally. She started getting regular media coverage and speaking at conferences.  And she’s now decided to take her findings and to use them to help more diabetes patients – to scale her approach exponentially.  Jen has now started a business – Duet Health – with a local Columbus developer, and is in the business of developing mobile health applications.  Her first, the EndoGoddess app, made it into the iTunes store this past fall, and is doing well.  It stands out from other diabetes apps (which tend to be limited to journaling) by embedding the motivational model developed by Stanford professor and researcher BJ Fogg.  The EndoGoddess app, targeted for younger diabetics, also includes a rewards-and-incentives program that is really interesting.  By complying with their treatment, patients are awarded points that can be redeemed for iTunes credit … and that credit is funded by their families, friends, or anyone who has a vested interest in their adherence to treatment.  Through Duet Health, she has also started to create content modules for hospitals that are designed to be “prescribed” (literally – the modules are listed on prescription pads) by doctors as patients are released from the hospital.

Today those modules cover topics such as physical therapy, orthopedics, and pregnancy, although there are over 20 modules either in production or on the roadmap. The hospital and its staff of health care professionals are thrilled … for the first time, they feel as though they’re able to have a more lasting impact with their patients by creating a mechanism for interaction (through trusted content) between appointments.  And it’s dead simple for the docs and nurses.  There are no instruction manuals required; just a simple, pre-written “prescription” for content in the patient’s release packet.

The future is looking bright for Duet Health, which has effectively tapped into the wealth of  young talent gathered around OSU.  They’re now working on more sophisticated apps that are designed to be a portal with properties similar to personal health records, but with embedded social media functionality and focused on helping users to connect with other users who are in a similar stage of their patient journey.  And it’s her feeling that in October, when hospitals start to be penalized for readmissions, there is going to be a significant uptick in the need for the work that she and her colleagues are doing.

Jen has spoken at the mHealth summit for the past three years. In her words, the mHealth space has evolved tremendously during that time – from “Is this going to work?” to “This is going to work – but what’s the business model?”  For my money, Dr. Dyer is well on her way to nailing that one.

How to connect with Dr. Dyer:

Her Company: Duet Health

Her blog: http://endogoddess.blogspot.com/

Twitter: http://twitter.com/endogoddess

Slideshare: http://www.slideshare.net/EndoGoddess

LinkedIn: http://www.linkedin.com/in/jennifershinedyer

YouTube: http://www.youtube.com/user/drjenshinedyer/videos

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Jennifer Dyer’s Recommended Network of “MDigitals”:

Dr. Mike Sevilla: https://twitter.com/#!/drmikesevilla

Dr. Bryan Vartabedian: https://twitter.com/#!/doctor_v

Dr. Wendy Sue Swanson: https://twitter.com/#!/seattlemamadoc

Dr. Kevin Pho: https://twitter.com/#!/kevinmd

In total, he spent 44 words discussing perhaps the most far-reaching legislation passed during his tenure, health care reform. The initial reaction was that the president was backing away from his signature achievement. But examining one number from one speech doesn’t tell the whole story. Here are a few more numbers that put the 44th president’s 44 words into context:

• 7: The number of words dedicated to health care in the Republican response, delivered by Mitch Daniels. If Obama was avoiding the topic out of fear of political fallout, the Republicans didn’t call him on it.
• 15: The number of words George Bush used to discuss health information technology in his 2004 State of the Union address. That was enough to launch a multi-billion dollar federal effort, complete with its own “czar.”
• 48. The sum total of Lyndon Johnson’s references to Medicare in his 1967 State of the Union speech, two years after the Social Security Act of 1965 created Medicare. The brevity certainly didn’t dampen the impact of the law.
• 270. The amount of Richard Nixon’s 1974 State of the Union address dedicated to his plan for comprehensive health care coverage. That bests Obama’s total for the last two years, combined. And we all know how much traction Nixoncare generated.
• 34,053: The word count from the administration’s brief to the Supreme Court on the legal challenge to the Patient Protection and Affordable Care Act. With three days of oral arguments before the Court in March and a decision around mid-year, there will be plenty said about health reform, even if it was absent from this year’s speech.

It’s clear that there is no obvious distinction between time spent on a topic and the attention it gets from policymakers, which explains why we don’t have hydrogen cars (116 words in 2003). Millions of words will be spilled on the topic of health reform as the legal argument (and decision) come and go this year. And millions more will be spilled during an election season in which all of the leading candidates have put stakes in the ground about health reform.

That’s not to say that paltry attention to health care in the State of the Union doesn’t matter. But — like so much else in life — the really important stuff can often go unsaid.

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When I started using twitter in 2008, I was amazed at how easy it was to connect with other folks who were beginning to think about the intersection of healthcare and social media.  I’m happy to say that I am still in touch with many of those folks – Mark Hawker, John Moore, Bob Coffield, Marty Trussell, Holly Potter and Dana Lewis, to name a few.  One of those twitter pioneers – and one of my first online friends – is a doctor who has inspired thousands with his groundbreaking work – Dr. Bertalan Mesko (more commonly known on the social web as “Berci”).  Every doctor in this program has the opportunity to choose the medium for their interview – and Berci chose a Q&A format.  So without further ado, meet one of the world’s leading thinkers on digital medicine.

Berci graduated from the University of Debrecen, Medical School and Health Science center in 2009 and started PhD in the field of clinical genomics. He is the managing director and founder of Webicina.com LLC, the first free medical social media guidance service for patients and medical professionals. He speaks at prestigious conferences; covers online international events and is a health 2.0 consultant for pharma and medical companies. Healthspottr.com included him in the Future Health Top 100 list.

He is the author of the award-winning medical blog, Scienceroll.com and the educator of the Medicine and Web 2.0 university credit course which is the first of its kind worldwide.

He is often sought out by the media for his expertise, and has been featured in publications as diverse as Nature Medicine, the New York Times, Al Jazeera, British Medical Journal and Wired Science, among others. He is a member of the Kairos Society.

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Greg: When you use social media, who’s your audience and what’s your purpose?

Berci: I have different audiences in different channels. On my blog, Scienceroll.com, my audience consists of medical professionals, students and nurses. On Twitter, I talk to everyone from e-patients to doctors. On Webicina.com, we create curated selections of social media resources focusing on different medical conditions or specialties for patients and professionals as well. Whenever I post something online, I choose the language, wording, links, etc. in order to fit the needs of my audience. Twitter requires fast interaction with pieces of information; Facebook is more about slow interaction, while a blog is like a public CV.

Greg: What’s your most effective method/channel for reaching that audience?

Berci: Even if I make the most contacts and have the more interactions on Twitter these days; I still believe my blog is my major platform. Whenever someone makes a search for my name, they will find my blog in the first place which I’m glad of as I control the information being published about me online. But to properly reach my audience, I need to use several tools such as Friendfeed, Facebook, Twitter, blogs, Youtube, Google+, etc. And I have to pay attention to avoiding the overlap of the content I publish in these channels.

Greg: What is the biggest danger facing physicians using social media?

Berci: I always tell my students whatever content they publish online will hunt you down. When I publish as a doctor online, I ask myself a question: Do I mind if this content is seen by millions of people? So to sum it up, the biggest concern is privacy. Doctors must learn how they can interact with their patients online. If I don’t want to share photos from my vacation with my patient at the grocery store, why I would do the same on Facebook by making my photos public? I help medical students know more about these issues in my course at the university which I will make globally public this February.

Bertalan Mesko Medicine 2.0 Promo – Rough from Larry Chu on Vimeo.

Greg: Are there any absolute do’s and don’ts you’d like to share?

Berci: We just published an open access social media guide for and about pharma in which we included a list of suggestions regarding what medical professionals should and should not do in social media.

Greg: What do you want the doctors of the future to know about the future of doctoring?

Berci: Recently, I published 7 features of the new generation of physicians in which I described the main points about these young students and doctors. In a nutshell, they are fast, mobile, technophile, balances, and online.

Greg: What communication devices do you use?

Berci: I have an Android smartphone and a Samsung Galaxy Tab.

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A huge thanks to Berci for his participation.  Make sure to follow his work:

My company: http://www.webicina.com/

My blog: http://scienceroll.com/

My Twitter: http://twitter.com/#!/Berci

And a sample from his reading list:

With WCG’s experience in the healthcare industry, we work with companies that provide treatments, devices and other products indicated for hundreds of health conditions each year. But it’s still humbling to learn about a condition like SWSD that affects so many people, and yet so few know they suffer from it.

For greater context, individuals suffering from SWSD typically work rotating shifts, the night shift or on irregular schedules (in other words, not 9 a.m. – 5 p.m.), often resulting in excessive sleepiness, difficulty concentrating, headaches and lack of energy. These can develop into more serious conditions such as insomnia or depression, or even result in serious accidents on the job.

To help shine a light on this issue, SharecareNow, powered by WCG published the SharecareNow 10: Shift Work Sleep Disorder, identifying the most prominent online influencers addressing SWSD and other sleep disorders within shift work industries:

1. Dr. Michael J. Breus, TheInsomniaBlog.com
2. Brandon Peters, M.D.,  About.com – Sleep
3. American Academy of Sleep Medicine, Sleep Education Blog
4. Lisa Shives, Sleep Better Blog
5. Cleveland Clinic, ClevelandClinic.org
6. National Sleep Foundation, SleepFoundation.org
7. Deborah Kotz, Boston.com – Daily Dose
8. Anahad O’Connor, New York Times – The Well Blog
9. Dr. Steven Y. Park, DoctorStevenPark.com
10. Dr. Catherine Darley, Naturopathic Sleep Medicine Blog

These experts and organizations expose a shift in how patients are seeking resources and information on how to treat their health conditions. In addition to relying on primary care or specialist physicians, patients are increasingly taking an active role in their treatment, seeking out numerous sources of information. And, in the case of chronic or long-term conditions, they’re following regular sources of relevant content like blogs, forums, news and Q&A platforms, and ultimately becoming a more informed patient.

So whether those suffering from SWSD read an article from Anahad O’Connor, or follow Dr. Breus’s blog, or research the condition on ClevelandClinic.org, these influencers have the ability to help patients find the right information, learn how to apply it, and finally receive the support they need.

With the SharecareNow 10 series of influencer lists, the focus is on sharing insights in a way that the average person can benefit and improve their health in a meaningful way. This is how health will be transformed.

Bob Pearson & Adam Pedowitz

Disclaimer: WCG works with a number of pharmaceutical companies, including some that provide treatments for shift work sleep disorder. These clients have not participated in this analysis.

About 8,000 people officially attended the J.P. Morgan Healthcare Conference, the biotech-investment marked by crowded hallways, expensive drinks and general excess. But a much larger audience, including me, watched the meeting from afar via new media, from a hundreds of webcasts to thousands of tweets.

I wanted to capture what the meeting looked like for those viewing it through the lens of social media, and four charts tell the story.

Two years ago, when online discussion of J.P. Morgan hit the mainstream, there were a few hundred tweets. A blog post at the time said the #JPM10 hashtag was “widely used.” A year later, the number of tweets had almost doubled. And we’ll nearly quadruple last year’s number. The online aspect of the meeting has exploded.

But it’s not fair to say that the in-person aspects of the meeting took a back seat to Twitter. A look at tweets in the two weeks leading up to the meeting shows that those on Twitter were interested in connecting in real life, not cyberspace. The most often-used word? RSVP.

So what companies garnered the buzz on Twitter? If you were a newsmaking biotech, that helped. So did presenting earlier in the week. And having Adam Feuerstein of The Street take a special interest in a company helped boost tweets. On this map (complete map also available), bigger circles mean more tweets and retweets including the ticker symbol. And thicker lines means more attention from a given tweeter.

Of course, for those of us in the communication game, it’s always interesting to see who managed to generate the most retweets. This sprawling map (complete PDF copy also available) shows every RT or mention about #JPM12 over the past three weeks — all 2,000 of them. As ever, the big drivers were journalists, with Adam Feuerstein — again — coming up as far-and-away the most-engaged guyon Twitter.

If you’d like more information on the flow of social information at a future meeting, please let me — or your WCG contact — know.

“Doctors are beginning to realize that Google is the new CV.”

- Dr. Bryan Vartabedian, on changes in physicians’ attitudes towards social media

Bryan Vartabedian was standing in front of about a hundred of his peers at America’s largest pediatric hospital –  Texas Children’s … some of the toughest critics around.  Pediatric Grand Rounds.  And he was about to talk to them about the ethics of physicians in Social Media.

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Anyone who works in healthcare seems to be imbued with the notion that doctors have no interest in social media.  Three years ago, they’d have largely been right.  And today?  Things are changing fast.  Manhattan Research tells us that doctors’ internet use increased almost 400% between 2002 and 2009, and anecdotal evidence would tell is that those numbers have been dwarfed in the last two years. There are now thousands of doctors who are using blogs, twitter, Facebook and YouTube to communicate every day – with each other, with other parts of the health system, and yes – with their patients.

Dr. Vartabedian, a pediatric gastroenterologist who studied at the University of Massachusetts, has over the last three years become one of the leading thinkers on the the role of social media in medicine.  But it happened more or less by accident.  Dr. Vartabedian (known to his patients as “Dr. V” and to his online audience as “@doctor_v“) originally had a much more traditional reason for establishing a social media presence – and it had little to do with doctoring.

In 2006, he wrote his first book, “Colic Solved: The Essential Guide to Infant Reflux and the Care of Your Crying, Difficult-to- Soothe Baby.”  One of his editors told him that any author needed to have a blog in order to help sell books … so he started Parenting Solved … a blog for parents focused on diet, nutrition and digestion for your kids (side note: wish I’d known about it sooner!).  The blog wound up becoming a quiet success, engaging an audience of parents and a way to amplify the point of view he’d espoused in the book.  It also provided an early “Eureka” moment: In 2006, when Novartis began the process of selling its Gerber (baby food) unit, Dr. Vartabedian wrote a post called, simply, Gerber for Sale. The post drew the interest of the European financial press, who subsequently interviewed him on the subject.  It was to be the first of many times that Dr. V would be sought out by the press based on his blog.  According to Dr. V, “It turns out that when you’re an early adopter of anything – in this case social media – everybody wants to talk to you.”  And when you’re selling a book, or growing a private practice, that can be a very good thing.

After a few years of blogging at Parenting Solved, Dr. V admits that he started “getting burned out with the ‘reassuring voice of authority’ for parents.”  And his interest online had begun to shift.  AMA News had asked him what doctors should be doing if they were approached by their patients on facebook, and so he wrapped his philosophy on the subject into a 9-step answer that eventually turned into a post on his new blog, 33 Charts: “9 Things to Consider when Patients Contact You via Social Media.”  The piece, written in 2009, is still being circulated as a social media primer for doctors today.  And 33 Charts, “the intersection of medicine, social media and technology,” is still going strong.  In fact, it’s become the center of Dr. V’s online community.  While he is active on facebook and twitter (where I met him nearly three years ago through the #hcsm tweetchat), the blog is where most of the action is happening for Dr. V and the doctors with whom he’s discussing the future of medicine.

Dr. V has often been quoted telling today’s medical students that when they retire, “the practice of medicine will look nothing like the doctoring of today.”  And while many young doctors are leading the charge, Dr. V believes that medical schools need to take a long, hard look at their model – which largely hasn’t changed since being introduced by Dr. Abraham Flexner in 1910.  Flexner’s ideas represented a radical departure from prior medical training – and Dr. V believes that a similar revolution is beginning now.  Vanderbilt University, featured in the New York Times’ WellBlog in December (Dr. Pauline Chen’s “A Medical School More Like Hogwarts“), has generated significant controversy in the medical community – but what they’re doing is just the beginning.  And certainly there are few if any med schools what have begun to train future doctors on digital communications.  They’ve been left to figure it out for themselves – or learn it from pioneers like Dr. V.  And the cultural change is significant for people who can be sued for millions if they ever make a mistake – and often when they don’t.

Dr. V noted that, “there is a real fear [for doctors] of declaring themselves or saying what they believe in a public forum …it comes form this history we have of keeping this therapeutic distance between us and our patients.”  But the same doctors who thought he was crazy when he started blogging and tweeting are now some of the same folks who are asking for his advice today.

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As he faced down the Pediatric Grand Rounds at Texas Children’s, there’s no doubt that Dr. V was feeling a little nervous about the talk that he was preparing to give.  Though he speaks and writes about controversial subjects on a regular basis, it’s never without wondering what his peers and mentors – those whom he admires and respects – will think.  He went on to give a talk that was meant to touch on the heart of doctors’ primary reason for being in social media:

“As physicians we have an obligation to be a part of this [online] conversation.  We need to be creating content.”  There is a lot of bad (or at least biased) health content online … and people are desperate to find support from a system that’s increasingly unable to give it – especially in an 18-minute appointment with their physician.  Dr. V knows that it isn’t surprising that people are looking to interact with their doctors online … as a pediactric gastroenterologist, the patients he interacts with have young moms who essentially live on facebook – so why wouldn’t they jump at the chance to hear from their doctors there?  And although there are plenty of doctors who aren’t well-equipped to create original content, “there is a role that ANY doctor can play, and that is to curate content.  It makes a TON of sense.”

The presentation at Pediatric Grand Rounds was a success.  He knows that there were some folks out there who will never really “get it.”  But there were many more who did … who stayed afterward to talk and ask questions, who are now reading his blog, and likely following Dr. V’s twitter account as well.  While 33 Charts may not always be focused on doctors and social media, it will continue to focus on the future of medicine – the place where Dr. V and innovators like him continue to lead us.

To see the content that Dr. V presented at Pediatric Grand Rounds (and you really should), check out “Physicians, Risk and Opportunity in the Digital Age.”

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Follow Dr. V on the following channels:

33 Charts (Blog): http://33charts.com

Twitter (@doctor_v): http://twitter.com/doctor_v

Facebook (33 Charts): http://www.facebook.com/pages/33-charts/113590062029306

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ODDS and ENDS

The tools in Doctor V’s Digital Tool Belt:

• iPhone/iPad
• MacBook Air
• Evernote (as a self-described “addict” – as am I: I count at least 8 posts where it’s mentioned)
• ePocrates (iPhone app) pill identifier
• Dr. V will frequently “prescribe” additional online resources to parents

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A sample from Dr. V’s physician reading list (going beyond the “CelebriDocs”):

#MDigitalLife is a WCG program designed to learn from and to showcase physicians who are blazing new trails in the digital world – changing the way that medicine is practiced and better health is realized.  The series intro is here.

As a result — in a fitting reflection of how starved people are for rules governing the use of new media technology – the document has been widely referred to as the FDA’s “social media guidance.” AdAge’s headline called them “Social-Media ‘Guidelines” in a widely cited piece. Slate’s headline used “Draft Guidance on Social Media.” FiercePharma’s headline talked about “sharing in social media.”

Though the excitement is forgivable, the headlines are not quite right. None of the larger philosophical questions about social media were addressed. None of the impacts of FDA inaction I wrote about last month have been ameliorated. It’s hard to imagine any large-scale changes in approach based on this document. Indeed, to the extent that the new guidance is helpful, it is in codifying a set of policies that are already in place.

What the FDA published last week is not social media guidance. It is merely guidance that mentions social media, or — in FDA’s parlance — “emerging electronic media.” It uses the words “YouTube” (once) and “Twitter” (once) and “blog” (once). The lack of ambition was skewered by former Merck policy guru Ian Spatz, who called the document “a belated lump of coal” on Twitter.

But even if the guidance doesn’t change the rules on social media, there is reason for optimism. The FDA is clearly conversant in digital media strategies and the new rules suggest an understanding of the way that companies are operating in the online space. When it comes to the narrow topic of unsolicited off-label communication, the agency did a thoughtful job of including a broad range of potential communication scenarios, from YouTube contests to public medical meetings. If all future guidance is as inclusive, we’ll begin to see the outlines of a coherent communications framework. Eventually.

Of course, the alternative is that the FDA could pull back the curtain on that framework even faster. Now that would be headline-worthy.

** WCG clients: We’ve done a brief analysis of the implications of the new guidance for both real-world and on-line communications. Please talk to your client partner if you’d like to learn more.

MDigitalLife exists to showcase how forward-thinking physicians are using digital communication channels to change the way that they practice medicine.

While doctors have been spending more and more time online for the last several years (Manhattan Research tells us that their professional online time increased from 2.5 to 8 hours per week between 2002 and 2009#), we’ve noticed an unprecedented explosion of online activity in the past 12 months.

The goal of this series is to learn from these “doctors of the future” and to share their thinking with a broader audience in the healthcare space … we believe that they’ll inspire other physicians, hospitals, nurses, health insurance and pharmaceutical companies to be more transparent and more inclined to dialog for the benefit of all.

The truth is that these doctors are still very much trailblazers. There has been little if any guidance from the medical establishment (e.g., academic institutions, physician’s associations, etc.) on how and why physicians can improve their own practices and possibly even the health of their patients by using online tools and resources. There are certainly some notable exceptions (e.g., the Mayo Clinic’s Center for Social Media), and we’ll take the time to learn from those folks as well.

But the focus here is clearly on the doctors. Their online activities are frequently misunderstood by their peers (if their peers are aware of them at all), but we hope to join them in changing that. Look for an interview here on WCG’s Common Sense blog every Wednesday morning … beginning with a leading light in the space – and a friend – Dr. Bryan Vartabedian.

View the LiveFromStubbs interview with Doug Ulman here.

The 3rd edition of the LiveFromStubbs podcast was a special one for me for more than one reason.  First, it was my first on-camera episode – and I’m always happy to share a stage with regular hostsAaron Strout and Kyle Flaherty.  But more importantly, the subject of our interview was Doug Ulman, the CEO of the Livestrong Foundation.  This is a big deal for me not only because of who Doug is – the CEO of one of America’s most remarkable and forward-thinking non-profits, and the man Fast Company has called “The Most Savvy Health Care Leader in Social Media” – but also because of how we came to be where he is.

A 3-time cancer survivor, Doug was forced to a difficult realization at a young age:

“[After being diagnosed with cancer,] All I wanted to do was connect with other individuals who’d been down the same path … I could not find them.  I thought I was the only one.  I felt all alone.  I knew all the statistics but I could not easily access other people.”

- Doug Ulman, CEO of the Livestrong Foundation at Social Health 2010 (SxSH.org)

Livestrong has dedicated itself to improving the lives of people affected by cancer worldwide.  And a big part of their strategy involves connecting cancer patients and their families with the resources they need … which often means helping to connect them to people like themselves – people who “have been down that road before,” as Doug puts it.  Over the last two years, Facebook and twitter have become the largest source of referrals of survivors to Livestrong.

One of the really unique ways that Livestrong helps people who approach them is to offer the services of a “Navigator” – a person who can help point them directly to the resources they need (and 90% of whom use twitter to interact with participants).  Increasingly, those resources either leverage the principles of social media (the groundswell vs. top-down, corporate hierarchy) or are literally built on social media platforms.  LiveStrong has positioned itself not as a be-all, end-all source for information or a lone behemoth, but as a “catalyst and convener” of all those who share an interest in living with (and ultimately beating) cancer.  Just a few weeks before our interview, Doug and his team hosted an event in Austin called the LiveStrong Young Adult Alliance – more than 200 organizations focused on helping young adults dealing with cancer.  That kind of crowdsourcing is a natural way to ensure that the best ideas bubble to the top, and that the right people are in the right place to make those ideas real.  And it’s use of Facebook has been particularly remarkable – operating separate communities that focus not only on different geographic regions, but also different types of cancer … whatever can deliver the most value to the audience it’s there to serve.

With that kind of thinking, it’s easy to see why Livestrong has made the transition from being a cause into a movement. Enjoy the video, follow Doug on Twitter, and be sure to check out the great work that Livestrong continues to do.  For more LiveFromStubbs podcasts, click here and subscribe!

The single biggest reason why 2012 predictions are wrong: they describe trends that are already happening, or — in some cases — have already passed. That’s the tricky thing about predicting the future in the new millennium: more often than not, the future has already happened.

Still, in leafing through dozens of lists, I’ve found five predictions that are indeed likely to define the communications industry over the next 12 months.

1. Credibility Becomes King. Or, at the least, prince. Writing for the Nieman Journalism Lab, Robert Hernandez said that content creation is so easy, and the supply of content so great, that what really matters is not the ability to reach the masses, but to have the masses believe you:

“With technology empowering everyone with the ability to create and to distribute, I predict — and wish — that in 2012 the new dominating factor will be Credibility. Actually, earned Credibility.”

Bookmark this. In a world where attention is limited, this is huge.

2. Brand Journalism Goes Mainstream: Penned by Derek DeVries, this was number 10 on PRSA’s inconsistent list of 12 public relations trends for 2012. Brand journalism is the idea companies can create content just as easily as media companies, and the smartest companies will drop the corporate-speak and start bringing their consumers/readers smart, pithy, valuable content. We’re seeing the trailblazers do that already. But the barriers to adopting this sort of mindset should fall even further next year. Will people take “brand journalism” seriously? They will if brands keep in mind Trend 1, above.

3. Big (Health) Data Becomes Bigger: Electronic medical records vendor Practice Fusion put out their own list, which included Circle Square‘s Michael Lake predicting that the growing amount of data stored in EMRs will prompt a boom in analysis of this kind of health data. While predicting a dramatic increase health IT penetration has been a sucker’s bet for the last decade, I’m confident that the increasing amount of data will shape how we understand and talk about medicine.

4. Influencer Rating Companies Lose Influence. Inkhouse says that the “influence bubble” will deflate in 2012, suggesting that narcissism-driven services like Klout will be exposed as something less than useful. That doesn’t mean that the need to understand influence will grow any less important. It just means that we’ll have to get smarter about how we define our terms. Real influence tends to work its magic in small, poorly defined groups, and those that develop the tools to enter and engage those groups will have an advantage over those that simply invent metrics.

5. “Conversations” Becomes the Killer App for Journalists: Joy Mayer, writing for Nieman, makes this plain: “In 2012, the divide will grow between journalists who are intently aware of and responsive to the needs of their communities and those who continue to make decisions based on long-ago-learned fortress mentalities.”

The sentiment here isn’t new. The wonderful Columbia Journalism Review article “The Newspaper that Almost Seized the Future” makes it clear that the idea of using electronic community to cement relationships between journalism and reader predates even the web browser. But we now have all the tools to make this real. A year from now, reporters who refuses to engage (on Twitter, in comments, on Facebook) will court irrelevance, no matter how big their news outlet.

Please use the comments to highlight other great predictions that I may have missed, and I look forward to seeing you in the New Year.

For half a million people, December through February is the peak time for a specific type of depression: seasonal affective disorder (SAD). Today, those suffering from SAD and other forms of depression can access valuable information, support and resources online. But with the volumes of information available online, where would one even begin to look?

Coinciding with Seasonal Depression Awareness Month, SharecareNow, powered by WCG identified the most prominent online influencers (see video) affecting the lives of millions of Americans who suffer from depression. The “SharecareNow 10: Depression” list is a strong mix of practitioners, authors and patients, who are are passionate about increasing awareness and support for those affected by depression:

1. Julie de Azevedo Hanks, MSW, LCSW, BCD, JulieHanks.com
2. Natasha Tracy, Breaking Bipolar
3. Therese J. Borchard, World of Psychology
4. Chato B. Stewart, Mental Health Humor
5. Nancy Schimelpfening, About.com – Depression
6. Daniel J. Tomasulo, PhD, TEP, MFA, Psychology Today
7. Marcia Purse, About.com – Bipolar Disorder
8. Rick Nauert, PhD, Psych Central
9. Jack Smith, Coping With Depression
10. Michael Friedman, LMSW, The Huffington Post

In the U.S. alone, an estimated 1 in 10 American adults report that they experience some degree of depression. Equally as alarming, while the average age onset of depression is 32, the group most affected by depression is ages 45-64.

We believe that in order to truly revolutionize treatment for depression and other conditions, we must find ways to unlock the power of collective knowledge – especially that of physicians, therapists, patients, and educators in health and wellness. Think about this: if you have an in-person conversation with your physician, it can be very productive, informative, have very little misinterpretation, and you can take positive action. Then, when you go online to interact with your therapist, other professionals and patients, the conversation should stay that simple, honest and clear.

We’re seeing that web platforms, blogs, forums and other social sites are facilitating open and honest conversations across numerous health and wellness categories. And in every category, a passionate, influential group of individuals is working to further that discussion and knowledge sharing. The “SharecareNow 10: Depression” list can be a tool for those suffering from depression and related conditions to start learning more about their situation, connecting with those who can offer support, and furthering their own conversation about treatments.

The ultimate goal, what we’re all working toward, is facilitating better health.

Best,

Bob Pearson & Adam Pedowitz

Bill Evans, EVP & Chief Digital Officer at Team Chemistry/WPP hosted and presented some interesting thoughts on pharma and social media:

• Pharma companies want to be innovative, but they don’t want to be first.
• In the world of pharma marketing online, “new” often equals “no” when it comes to legal and regulatory departments. Data doesn’t solve this problem. It takes education.
• The bandwagon effect: “I just saw that so-and-so company is using Google+ now. Why aren’t we?”
• The fallacy of scale: Bigger doesn’t necessarily mean better. Or the myth, “We can’t use this new media tool, because it doesn’t work for everyone.” Brochures don’t work for everyone, but we still use them.
• Skeuomorphs: I know … I didn’t know the term either. A skeuomorph is a legacy element to an object that is in there because it’s always been there but serves no real purpose (maple syrup bottle handles, spokes on hubcaps, using a floppy disk icon for “Save As”). Many people at organizations like to keep these legacy processes simply because … they’ve always been there.
• Be sure you’re considering to socialize everything rather than coming up with a social media program.
• It’s okay for pharma companies to have real-time conversations with consumers. They do it all the time. It’s called the telephone.

Eileen O’Brien of Siren Interactive and founder of the Twitter chat #socpharm stressed the point of creating “shareworthy” information. When you create content, think to yourself, “Would I share this?” Next up was a panel of patient advocates who told some pretty gripping stories on what they face on a daily basis, living with a chronic disease (or two or three). From their discussion emerged one telling statement as to how they wish to be treated. “I’m not my disease, but if you haven’t met my disease, you haven’t met me.”

I have to say that my favorite of the day was David Thompson, U.S. Social Media Strategist for Boehringer Ingelheim Pharmaceuticals, Inc. His charming English wit was accented by an honest and no-nonsense approach to social media strategy for internal comms. He even managed to pull off a metaphor of Old MacDonald’s farm to represent internal social media policy. Healthy Women & Mom Central Consulting have been doing some interesting work together to reach moms via a network of influential mom bloggers about health topics and products, without being overly commercial in their outreach.

Overall, it was refreshing to see that over half the audience worked at one pharma company or another. Pharma is taking more interest in how social media affects their company and their brands.

Looking back, the lack of guidance might have had as big an impact as actual FDA action would have. There are 5 major consequences of the FDA decision not to move ahead:

1. Branded promotion has been stunted. Branded promotion online exists, but it has yet to flower, for the simple reason that the risk of being accused of improper marketing far outstrips the benefit of educating doctors and patients. The lack of guidance only inflates this perception of risk and stems the flow of creative ideas.
2. Unbranded promotion has been delayed. There are some excellent examples of pharmaceutical companies doing great, creative work online that is providing clear and obvious benefit to the health care system (including some great work by our clients), but these pilot efforts could have been blooming two (or more!) years ago. Instead, fear and uncertainly slowed their trajectory. Now that industry has figured it out on their own, guidance might not have a huge impact.
3. The public health has (probably) been harmed. While pharma companies — which arguable have more expertise in certain arenas of health care than any other organization — have been shackled on social media, there continues a rising tide of pseudo-science and fearmongering online. The best way to fight lousy information is with good information. Restricting the ability of industry to join this conversation has been a net benefit to those who with an anti-science agenda. (This was at the heart of an analysis that my WCG colleagues presented to the FDA more than 2 years ago.)
4. Basic questions remain unanswered. No one expected comprehensive guidance, but there has always been hope that the FDA would weigh in on some specific questions, such as whether — in a character-limited environment (Twitter, AdWords, etc.) — pharma companies were required to include or link to an entire package insert. Companies have made their best guesses, but, after years of study, only the FDA knows for sure what the rules are.
5. The agency has opened itself to charges of hypocrisy. The FDA has itself become increasingly skilled with its use of social media tools, even as they refused to push out guidance. It creates an unusual and ironic playing field: the FDA has great latitude to use modern communication tools to inform the public through a variety of channels, but it has stymied the industry’s ability to follow suit.

Though I have long been a skeptic that FDA guidance would be a magic elixir for industry, there’s no question that it has caused some damage, and that some of that damage can’t be undone. Still, the optimist in me wonders if this could still be the year. It is too much to hope for the FDA as social media Santa this year?

The publication, by MIT’s Damon Centola, recruited people into one of two identical online social networks dedicated to fitness. Participants in both networks had about a half-dozen connections, but in one group, those connections were random. In the other group, the connections were made to increase the chance you’d be linked to someone like you (age, sex, body-mass index).

The researchers then invited certain non-obese participants to try out a “health diary.” If the participant adopted the diary, his or her six friends would also have the opportunity. The question: would health diaries spread quicker through the random network, or the one where people were grouped by their demographic similarities, a phenomenon called homophily.

The answer wasn’t clear before the study: while we tend to take cues from people like us, changing our immediate community, behaviors have a way of not jumping easily from community to community. Sure, the healthier part of the network might get on board, but would grouping healthier people together make it tougher for the idea to spread to obese participants?

As it turns out, the answer was “no”: obese participants actually benefited the most, even though they were the most distant from where the diary concept was introduced. In the other group, with random connections, fewer obese participants adopted the diary, even though they may have been closer, network-wise, to where the diary was introduced. Being surrounded by similar individuals boosts the odds of changing a behavior.

A year ago, Centola published a related study that found that networks built around small communities, rather than varied and distant connections, adopted health behaviors faster.

Taken together, the studies show that it’s not who is in a network that counts, but how individuals arranged in that network. The obvious implication is for new health networks built around mutual support.

But there are huge consequences for communications, too. Digital communication means that information no longer always flows in a hierarchical way, from media outlet to consumer. Instead, information flows through a network that looks a lot more like Centola’s models. Understanding network relations will be as much a core competency for communications and integrated marketing as media relations was a generation ago. Centola’s work is the first step in teasing apart what nodes and vertexes mean in the real world.

That means the focus is on not only “what you know” and “who you know,” but — increasingly — “where you know”: where people and information fall in the myriads of networks that now define us.

Imagine your next visit to your doctor, whether it is for a routine check-up or to discuss a specific health condition.  We know that everyone involved, from doctors to nurses to pharmacists, will focus on how to provide you with precise care and the next steps to improve your health. 

We’ve always been impressed by the commitment and care that healthcare provider’s exhibit day in and day out. 

But then you leave the office.  And that’s when the issues emerge.

Patients need to learn more about what they just heard.  Since few of us have gone to medical school ourselves, we actually need time to read, absorb and process what it means.  And as we go online, we have to fight through another issue – the fact that approximately 85% of all healthcare blog posts are spam.   What and who can we trust to learn about our health?

Whether you are proactively managing your own health or visiting your physician, or taking care of someone else, you are likely to only have a handful of interactions with medical professionals each year.   Yet, our health is part of our daily life – it’s part of who we are and what we care deeply about — and, as a result, we think about how to improve it each and every day, ranging from whether we should eat a certain food to how we avoid cavities to stopping smoking to looking for a clinical trial for breast cancer. 

 What we do know is that in our search for the right information, the answer is not another website.  It is not a mobile app.  It is not a social media channel.  It is not more advertising.  It is not many things. 

What we need is rather simple. 

We need to empower the world’s experts to share the best information with you directly. 

Working together, as one healthcare ecosystem, we will learn together every day of the year.  Physicians can learn from each other.  Healthcare providers can do the same.  And patients can know that they can depend on receiving the best available information, often directly from their physician, hospital or manufacturer of a brand, device or application. 

When we all work together to “share care”, we create the ability to transform health.   When we combine our collective IQ, we can provide the most helpful content in the form of Q&As, images, videos, mobile apps and more.  We can provide you with many ways to learn and make it more efficient to do so.  We can provide content that you can trust. 

Dr. Oz, who is the inspiring voice of Sharecare, provides the perfect example of what we will accomplish as a team.  He wants to help us transform our health, as individuals, today.  Not tomorrow, today.  And at the same time, Dr. Oz is pushing all of us to find new and better ways to improve our health via education, application and information for the long-term.  When we combine forces with healthcare providers and influencers who know a specific disease or condition inside and out, we have the right ingredients for success. 

We’ll now be providing a new level of insight for our Sharecare partners so they can provide people – provide you — with the best possible information, applications and care online.    Called Sharecare Now, powered by WCG, partners will be able to identify the exact influencers, sources, language, content and syndication network to reach the people who will benefit the most, whether we are focusing on Anaheim or America.    It is an important step towards getting the right health and wellness content to the right people in real-time. 

We hope you join us on this journey to partner and focus on how we can all become smarter about healthcare and become more precise in how we share information and deliver the best possible care every day of the year.

Jeff Arnold                                                          Bob Pearson

Founder & Chief Architect/Sharecare     Chief Technology & Media Officer/WCG

Note: Video of Sharecare Now discussion available here

The workshop group and the following discussion on twitter concluded that medical education should:

• address an actual educational gap, and not reinvent the wheel
• define and refine clinical practice
• be ongoing, have varied formats, and be cross-speciality
• revisit a message regularly and consistently across channels
• address the different learning styles of the audience
• be field-tested and use tools to better measure quality and outcomes

Here at WCG we believe in integrated communications and apply the ‘pre-commerce’ model of evaluating outcomes not just outputs across all our activities for clients, including medical communications. We believe that educational outcomes can be measured as further message dissemination as this demonstrates ongoing assessment of data and individual ambassadorship.  We also feel that digital technology enables personalization of learning to different learning styles and assessment of quality and outcomes. Our ‘education through interaction’ approach also leverages clients’ cross-functional data and insights, and focuses on doctor-patient interaction and interaction between healthcare professional roles (e.g. nurses and GPs; primary and secondary care professionals; different specialisms).

Visualizing networks — to so-called social graph — this way exposes one of the great and underappreciated truths of the digital revolution: while the influx of new tools that have driven the cost of publication close to zero has empowered Joe Public (and spawned terabytes of “consumer-generated content”), the most significant impact of the digital publication revolution has been not on individuals but on organizations: non-profits, professional associations, advocacy groups and the like.

We’ve looked at several health related “ecosystems” and found that — perhaps unsurprisingly — that the glue that holds these communities together is associations. Examine heart disease on Twitter, for instance, and it becomes instantly clear that the American Heart Association and the American College of Cardiology are connected to all of the important voices in the area.

These organizations aren’t necessarily spawning trending topics or collecting hundreds of thousands of followers. Instead, they are quietly serving as the hub of a web of influencers, providing authoritative perspective on topics narrowly tailored to their own ecosystem. And the impact is clear. At the last two mammoth medical congresses — the American Society for Clinical Oncology annual meeting and the European Society of Cardiology meeting — the most influential tweeters by any measures have not been journalists or physician opinion leaders. It’s been the organizations themselves.

And the power of these kinds of groups will only grow as they build out editorial capabilities. The Mayo Clinic — another hub group in health ecosystems — is sending blogger and arthritis advocate Kelly Young (RA Warrior) to next month’s American College of Rheumatology meeting as a member of the press. It’s probably not too early to wager Mayo and Young (along with ACR itself) will dominate the information ecosystem of that meeting.

This all means that communications pros have to continue to expand their vision of “reporter” (or “influencer”) to included these kinds of groups, and re-tool their engagement strategies to account for the reach and authority of these sources of information. This requires a new skill set, one that’s different from traditional media relations and more complex than simple “blogger/Twitter outreach.” But acquiring that skill is crucial to the future of communication.

Lets look at doctors, for example.  Physicians have the power to teach both patients and students of medicine.  One body of pupils learns to treat the needs of others while the patient learns to treat the needs of the self.  On the Internet, a physician’s ability to share his or her rare knowledge is unparalleled.  Both med students and patients are turning to the Internet for answers.

Our world is changed.  The permutation of analog data and digital access is absolute; in a short time there will be few who recall an inability to draw from an infinite well of opinion and fact at the moment an impulse draws their focus.  We won’t remember a time when we couldn’t Facebook a question and get a ‘like’ or two.  Our reliance on our network to consider the problems we face is primeval.  Even cavemen had tribal council.  But never before has it been so easy to ask.  Never has the wisdom of the crowds been so present in interpreting even the most banal pontifications.  Dinner selection: Yelp.  Movie selection: Rotten Tomatoes.  Lasik surgery selection: Farmville Ads.  We now forge our decisions through social pondering.

8 Bit Dr. House

Websites like WikiAnswers and Sharecare (client), and features like Linked In Answers and Facebook Questions are popping up all over the Internet.  For some people, entering vague keywords into Google and WebMD is an unrewarding process.  The search results can be unwieldy and the answers can come from just about anywhere.  On Linked In, you can see who is answering your questions, and if they’re in your network, there is a higher probability that you’ll trust their answer over something you read through Yahoo answers or on Wikipedia.  This is truer with health related questions.  Sharecare will sometimes even give you answers from licensed medical professionals, who dispense their advice with caveats for your protection.

Pharmaceutical and beauty companies alike are employing physicians’ world-over to answer questions on online forums, advise tweet-chats, and write expert opinions in blog posts.  Physicians need to be aware that not only are their patients getting information about their health needs on the internet, they’re starting to expect medical advice via social networks.  If I can find everything else I’ve ever wanted to know about the world around me through questioning my social networks and the tools that expand them, why can’t I learn what to take for this lump?  Well, there are many reasons why I can’t, but the fact that I’m even asking represents a change in the way I think about learning.

This trend isn’t going away, because if you haven’t realized, asking the network is a behavior we were born with.  Instead of neglecting the digital clamor, purveyors of answers would do better to listen—even if they intend to never respond.  Doctors: people will listen to your caution, but only if you warn them.  Make sure people know it takes testing and observation to make a diagnosis.  Make sure patients aren’t trampling on the sensitivity of your consideration by taking the articles they encounter online to heart.  People will always ask questions.  Better for you to be there to answer them than not.

Following initial hiccups in uptake of the CDF due to understanding and navigation of the application system, Professor Mike Richards – the UK’s Cancer Tzar – reported that over 90% of applications to date had been approved, many related directly to the management and treatment of rarer cancers (this being those outside of the top 4: breast, lung, colon and prostate).

Cancer52 welcomed this news but did caution that there were still some areas in the UK where clinicians still seemed unaware or unsure of how to access the CDF.

One of the greatest challenges facing those with less common cancers is awareness,early diagnosis and prompt access to effective management. Professor Richards felt that the Awareness and Early Diagnosis Initiative set up following the Government’s health policy agenda would identify ways to improve this through the identification and sharing of good practice across the UK.

A number of attendees called on the need for further research into genetic markers, similar to those already being used in the NHS that would help to ensure that treatments are given to those that will see greatest benefit, eg use of K-RAS testing.

This approach will allow stratified medicine to become a reality and outcomes to be significantly improved AND make better use of NHS resources. Testing such as this is a priority for the NHS.

Professor Richards stated that the greater sharing of information across specialists treating patients with different cancers would increase local knowledge and improve management and he called for increased creation and usage of MDTs (multi-disciplinary teams) across the NHS.

Cancer52 represents rarer and less common cancers that account for over 52% of all cancer deaths.

 Genentech/Roche’s blockbuster monoclonal antibody rituximab, for example, loses patent protection in February 2012, and there are already 6 biosimilars hot on its heels, in a race featuring Sandoz, Spectrum and Teva.

Forecasts suggest annual sales of a rituximab biosimilar will reach $500 million in the EU alone.

 But what are the market access challenges facing drug companies developing biosimilars, and how can Pharma companies look to overcome them?

These topics were discussed recently at a PM Society event attended by WCG, ‘Understanding the Impact and Critical Elements of Market Access for Biosimilars in Europe’, held at the Royal Society of Medicine in London. The panelists included Dr Rakesh Virma (Senior VP at Prescient Life Sciences), Paul Tredwell (Head of Biopharmaceuticals at Sandoz UK) and Dr Anthony Grosso (Principal Pharmacist at University College London Hospitals).

 The panelists gave their perspectives on the impact regulatory changes will have / are having on the biosimilars market, and offered interesting insights into the future for biosimilars.

 The EU is still the leading light for biosimilars – 14 biosimilars have already been approved here and, interestingly, uptake seems to be regional, with Yorkshire in the UK ranking highest for biosimilar use.

In the US, guidelines are still being developed; the FDA this year requested $124 million of the 2012 budget to develop a ‘biosimilars pathway’. This could, however, prove to be a pathway to nowhere, with payers arguing that more data are needed to prescribe than the FDA had planned to request.  

One thing the panelists all agreed on was that once regulations do finally settle in the US, (predicted at the end of 2011, although the latest reports suggest that the top-line details could come out any day now) this will have a huge impact on the EU space, adding pricing pressures as global companies enter the market.

 Globally, before a biosimilar can be presented for approval, it must demonstrate equal safety and similar efficacy in clinical trials; however, despite this, we are still seeing resistance, particularly from clinicians.

According to Dr Grosso there are four key drivers for this resistance: Clinicians feel there is a lack of information around biosimilars data, misinformation on how a biosimilar is developed, and a key concern over how using biosimilars might affect their relationships with originator drug companies.

 So how can Pharma ensure clinicians are buying into biosimilars?

Paul Tredwell of Sandoz UK has worked in originator and generic/biosimilar markets, and said “Clinical trials must be more transparent. Sandoz invests heavily in clinical trials and clinical access, and biosimilars require much more investment than generics (but less than originators.) We spend $75-$250million on development over 7-8 years before bringing a biosimilar to market.”

 Paul also recalled Sandoz meeting with the NHS “hundreds of times” to educate staff on biosimilars, and how they are developed.

 The panel agreed that the market for biosimilars is complex, and there are different concerns in each disease area.

While clinicians and patient groups are focused on safety and efficacy, payers are also looking for health economic data, tenders and dose equivalence, and market price.

With this in mind, Paul suggested Pharma companies need to take a more branded approach to marketing biosimilars in order to access complex products and disease areas, explaining that each brand must behave differently in each market

 What about cost? Are we going to see prices slashed versus originator drugs, due to less investment for companies, reduced time to market, and fewer patients needed in clinical trials?

The improved affordability of healthcare that could result from the use of biosimilar medicines is very real.

As an example, the EPO biosimilar introduction in Germany resulted in €60m annual savings in the first year, and it is predicted that biosimilars in Germany alone could contribute to €1 billion annual savings from 2017.

 Tredwell claimed that although cost is not the driving factor in manufacturing biosimilars for Sandoz (patient access is…), they are committed to marketing biosimilars at a 20-25% discount versus originator products.

 As 2013, and the first approved monoclonal antibody biosimilar approach, along with an imminent announcement from the FDA, we are set to see the future for biosimilars more clearly – watch this space!

And it’s not just celebs that have been able to build themselves into experts: advocates and advocacy groups armed with nothing more than a Twitter handle or a Facebook account can easily organize dedicated groups of meaningful size. Most of these groups are welcome additions to the marketplace of ideas, but some peddle false hope or stoke misdirected anger.

But in the cacophony, one set of voices remains under-represented: those of doctors and other public health experts. This isn’t entirely surprising: the medical hierarchy is built on commitment to patients, research and medicine, not to social-media volume. Doing hand-to-hand online combat with former Playboy bunnies or pseudonymous  voices is time consuming, and success hard to define. Perhaps that’s the reason why — when professionals fight back — they usually do it in the traditional way: a book, some interviews, a TV appearance or two.

Take Paul Offit, the University of Pennsylvania vaccinologist who has emerged as the best, most sane voice in the vaccination debate. He’s written two fantastic books.  He’s had op-eds in the New York Times, been reviewed by NPR and even had a head-to-head with the Mike Wallace of our time, Stephen Colbert. But he has no blog and he has used his Twitter account, dormant since May, only 33 times. Jenny McCarthy has tweeted 33 times in the last 48 hours (including a half-dozen autism-related posts).  On paper, there is no doubt who should wield more authority. But this battle isn’t being fought on paper. It’s being fought online.

Still, nowhere is it written that health care authorities can’t provide strong leadership online, and there are at least three models to consider:

• Dr. Leonard Lichtenfeld: The American Cancer Society’s “Dr. Len” has a blog and an active Twitter account. But it’s not just that he has the new media tools — it’s a rare organization that doesn’t — what sets Lichtenfeld apart is how he uses the tools at his disposal. His posts are topical, and he is a participant on Twitter, carrying on conversations with advocates and media. ACS has a number of tools for getting their message out, but none seem as authentic or authoritative as their online efforts.
• Dr. Harlan Krumholtz: Building a social media audience from scratch can be difficult, but Krumholtz, one of the leaders in cardiology, has leveraged existing networks to ensure his voice can get out to the public, unfiltered. He is plugged into the Forbes.com as a contributor, giving him the ability to reach a broad audience, and he works with the publisher of the New England Journal of Medicine to edit CardioExchange, a cardiology-specific social network.
• Dr. Howard Luks: And for brute force on Twitter, it’s hard to top Luks, an orthopedist in New York, who has generated nearly 15,000 tweets on the intersection of technology and medicine. While he has a blog (and quick, effective videos and a Posterous account), it’s clear he’s focused most of his energy on Twitter, and the payoff is obvious.

These aren’t the only docs who have successfully leverage social media, but the strategies these three have employed could be templates. And we need templates. Social media isn’t a toy or a distraction. It is, for better or worse, a tool that helps define how millions view medicine. Right now, that tool is not being used most effectively by the people that we most need to hear from.

[ADDENDUM: If there are docs out there that want to build their digital footprint but aren't entirely certain how to get started, please drop us a line and we'll point you in the right direction. Increasingly, there are excellent tools to amplify expertise that don't require the care and feeding of a full-fledged blog. One of these options is Sharecare (disclosure: Sharecare is a WCG client), which has built an expert-driven Q-and-A site for health questions.]

On the same day, Rockoff’s colleague, Ron Winslow, published an account of how a group of patients with spontaneous coronary artery dissection, or SCAD, found each other and — working together — pushed researchers to tap into their cases through a formal study. The end result is expected to be an expansion of what science knows about SCAD, a disease heretofore too small to generate interest in the research community.

The implications of these two pieces are clear: the march of science is slicing patients into smaller and smaller groups, and the information needs of those patients is getting larger even as the population of people in the same boat shrinks. The result is that, even in this era of informational surplus, small groups of patients may find the specific facts they need remain elusive.

Fortunately, the counter-trend is equally powerful, and the success of SCAD patients — along with other patient groups such as patientslikeme.com or the ACOR.org forums — are providing new and important information-sharing outlets for these narrow groups. But these groups are only work when people can find them. To truly unleash the power of online health, we in health communications need to do three things better:

1. Patient support resources should be as much a part of what we provide to the media as press releases, disease-specific material and other background documents. From the outside, it can be difficult to establish the go-to locations online for specific groups of patients or caregivers, and raising the profile of such groups provides an enormous service to patients. (An example of where we are falling short: The WSJ SCAD story, while detailing a triumph, did little to point would-be participants to the very resources it discussed. For more information on the study, please see this page from the Mayo Clinic.)
2. There must be an active effort to help make patients more web-literate, specifically in the area of health. My local hospital is running three dozen different classes and events in the month of September — everything from childbirth classes to cooking classes to relaxation/breathing classes — and not one of them is focused on teaching people to be e-patients.
3. Communicators, especially those who work with industry, must come up with ground rules around direct interaction with these emergent communities. There is a great deal of opportunity to bring expertise and resources into the dialogue, but it’s important that “outsiders” adhere to strict standards of transparency. (Shameless plug: this topic is the subject of a SXSW panel that I’ve proposed: “Friending Pharma.” If you haven’t checked it out and voted, please take a look.)

The move to define diseases into smaller and smaller groups isn’t new, but it will have a profound impact on everything from study design to media coverage. And the sooner institutions and industries adapt to that reality, the quicker we can get to that future.

* Disclosure: WCG works with Pfizer, but WCG does not work on Xalkori.

The concerns raised by the Times piece exposes a chink in what was supposed to be one of the Internet’s great strengths: the ability to shift power away from old-school experts — academics, magazine writers, and the like –  to the online multitudes, who could (the argument went) give better, deeper and more accurate snapshots of products and services. Except that the wisdom of the crowds has been less valuable than advertised, in part because of the issues raised by the Times and in part because the opinion of amateurs is simply less valuable.

This isn’t just an issue for rating sites. Edelman’s annual Trust Barometer shows old-fashioned subject-matter experts are back in vogue and that the trust in “people like yourself” is slipping, even as the ability to solicit the opinion of friends has grown easier.

In health care — my area of focus — the shift could have a profound impact on how information gets communicated. Review sites for everything from doctors to medications have been slow to take off, and growing concerns about the accuracy of such reviews could suffocate the nascent industry. As communicators, there are three specific ways we can adapt to this shifting reality:

1. Providers of health care products and services — from pharmacists to pharma — should prospectively announce that they do not and will not interfere with ratings sites by encouraging or discouraging any specific type of review. The hospitality industry loses credibility every time an accusation of payola is leveled against a restaurant or hotel. Those in health care can’t afford that kind of reputational hit.
2. Ratings and rankings will remain popular, even if consumer reviews lose their luster. People want data when they are making choices, and if data from reviews isn’t reliable, they’ll look elsewhere. Right now, leading news outlets are building and refining tools that allow consumers to crunch all sorts of hospital quality and outcome data. And this is only the first step in a world in which everything from FDA adverse event reports to disciplinary records come online. Ignoring these “data journalism” efforts is just as dangerous as ignoring consumer reviews.
3. If subject-matter experts are again growing in credibility, models of influence should be altered to reflect that fact. While it’s not clear precisely how that is playing out, it could be that medical information sites that tout outside review by vetted doctors (such as WebMD or A.D.A.M.) will grow in influence, while patient and provider blogs wane. Though this isn’t a zero-sum game with one winner, even a small shift in information consumption could have profound effects.

It’s wrong to suggest that we’re in the twilight of consumer-created information. There remain powerful forces pushing us toward sharing more information about our experiences with each other. But it’s also clear that, despite the technical ease of such sharing, the wisdom of the crowds won’t replace the need for traditional models of expertise. And if the credibility of the crowd is being questioned, vetted, trustworthy experts may become more valuable than ever.

One question that’s been on everyone’s mind is, “Who did what?” People have been curious to know who took their Pages down, are they allowing comments, have they implemented a policy? Jonathan Richman’s Dose of Digital created a great post that outlined which Pages stayed and which ones didn’t. We decided to take that to the next level to answer some of the above questions.

On this Google Docs spreadsheet, we’ve outlined what certain companies have done with their Facebook Pages after August 15. You’ll see that only 10 of the 62 Pages shown have actually gone away. A great sign that these companies are committed to social media! If you see that any Pages have updated in the meantime, feel free to leave a comment here, and we’ll update the spreadsheet.

Pharma Facebook Pages

We created a Page to test out this feature for the fake drug, Testaquel. Click here to view it. Here is a summary of what’s new.

• New “Safety Information” field added to any Page whose category is “Health/Medical/Pharmaceutical” (within Companies & Organizations) or “Drugs” (within Brands & Products).
• The first (approximately) 340 characters will display at the bottom of the Page with a “See More” link to show the remaining text.
• The remaining text does not seem to have a character limitation of consequence. We previously reported the ISI character lengths of the top U.S. drugs, the largest of which was 5,779 characters. For Testaquel, we tried a character length of 8,000, and all of the text displayed on the Page after hitting “See More.”
• This safety information, shown on the Page as “More Information” will be displayed at the bottom of the Page, after the Wall posts.
• This change is live now, so you can add in your drug’s ISI to this new field.

What does this mean to you? Two things, mainly.

• You can now have your ISI displayed right on your Wall. The fact that it is text (and not an image) is also important. For those Page visitors who are visually impaired, they can have the ISI read to them by their browser software.
• You will still need to consult your regulatory department to see if having a partial ISI on the Wall satisfies FDA requirements for fair balance. The fact that the user will need to click “See More” to see the full ISI may present a challenge. The fact that it will almost always be ‘below the fold’ of a Page may present another.

I do applaud Facebook for listening to the pharma industry and responding with a solution. Like much of Facebook, the Safety Information addition is simple and elegant. Whether it satisfies FDA requirements for fair balance remains to be seen.

We all agreed that access was much more than just the issue and challenge of access to a new healthcare treatment; it also embraces access to health service provision, financial and manpower resource, access to technology, information and multiple stakeholders.

Some of my colleagues have already drawn out some of these themes in previous blog posts and I wanted to expand on the concept of access to information – and more directly access of patients to information.  In the developed world there has been a significant overall shift in healthcare in the last couple of decades towards improving quality of life, with patients and populations being more demanding and wanting to see greater value from their healthcare, but do they have access to the right information that could effectively inform their individual decision-making?

The education provided to patients about a medical condition, its management and treatment varies tremendously – and the way that information is provided is also highly variable. Indeed, if we could improve the communication between a patient and their doctor, and if clinical management was based purely on evidence and cost-effectiveness there is a view that we could afford most, if not all, our necessary health needs – why? One reason put forward by economists is that we would see dramatic reductions in waste, not least because of improved patient adherence to medication, but also in terms of more effective use of healthcare resources, including manpower as well as appropriate use of new technology.

We are now in an environment where patient and doctor often access the same information through their use of Google – which is not only the number one source for patients to find out about a condition or to self-diagnose, but has also been shown to be most doctors first reference source when looking up a diagnosis and potential management options; surely this creates an environment whereby patients and doctors can access the same information and use this to create more meaningful and impactful dialogue, leading to better management and improved outcomes.

However, the challenge to all stakeholders involved in educating and communicating with patients is to work together to ensure that online education is of high quality, easily accessible and understood by the public, not just doctors and preferably produced in partnership – this means bringing together patients, patient advocacy representatives, healthcare professionals, policy makers and healthcare providers together with relevant industry partners.

Healthcare information has to stop being a lottery – the better a patient understands their situation, the better they can self-manage, make informed decisions about their healthcare provision – and then improve outcomes (which are important to the patient, not just to the doctor or the healthcare provider – what are appropriate and effective outcome measures is another theme for another discussion!).

WCG Access Roundtable

In my previous post, I mentioned what I think has to be the Holy Grail for pharmaceutical companies in an era of increasing economic pressures balanced by empowered patient action: supporting access for their products, making the most of budgets and truly delivering education and action in an inclusive and interactive way.

The recent WCG Access Roundtable brought me right back to that thought.

Expressing value beyond product for each stakeholder, including the empowered patient

We heard from Mike Sobanja that solutions for individual patients don’t always deliver the best for the whole population – i.e those making budgetary decisions often have to take a societal view of value. Defining both wellbeing and the value of healthcare is therefore key to supporting patients’ access to the best healthcare. This begs the question: with patients wanting the best for them as an individual, and payors looking at the best for many, how can we support healthcare professionals in explaining this dichotomy to a patient?

Understanding and supporting patient needs

The industry and companies like WCG have a role to help healthcare professionals understand the language patients use, and what’s really important to them. Three forces are impacting the information healthcare professionals provide to patients and the discussion that ensues: 1) there is just so much more information out there these days; 2) healthcare systems are increasing the drive for patient choice; 3) due to the current economic and human environment payors and policymakers must focus on promoting self care. So we need to support healthcare professionals in ensuring patients get the best information, with meaning for them, and are able to absorb it and act on it, without feeling let down by the system.

Inclusive and interactive education

We heard from Helen Johnston that in the UK, the role of NICE is shifting from examining individual products to look at the broader clinical / patient pathway. So, how can we support this communication of value at each stage in the pathway, for the most relevant stakeholders?

These questions are precisely why WCG’s approach to medical education aims to deliver tailored programs for each healthcare professional along the pathway the patient takes through management, and to support these professionals in the ongoing dialogue they are having with patients.

Going beyond explaining the primary data to understanding and delivering value

When discussing the inherent values of delivering scientific innovation compared with improving patient management and outcomes, Jon Sussex and Mike Sobanja hit upon another fascinating point, which was clarified by Helen Johnson when she explained that the value beyond product must be communicated to meet all the audiences’ information needs – we must make the case for patient and healthcare system value not just the main data points.

This is why WCG’s approach to product communications and medical education is founded on a cross-functional approach – working with all functions in a client’s company. There is important information to help communicate the value of a solution for patients not only sitting with the medical team from the clinical trials, but also with the original development team, market research, heath economics and outcomes research, and advocacy relations.

Working together to support access

The panel also discussed the importance of collaborations and partnerships between advocacy, industry, and health providers, which for me reinforces the need to look towards new, more rigorous and ethical forms of medical education and patient education. You’ll be hearing more on that from me soon.

But there’s one area where the unseen hand of personalization may have a more positive risk-benefit profile: health. Right now, I provide a lot of information online that could be hugely important to my health. In addition to actually search for health information, I download recipes, plan vacations, map running routes and a thousand other things that have a measurable effect on my physical and mental well being. And Google knows all about that.

With all of that data, I’m sure the cookies on my machine tell an interesting story about my health history that can be used to better customize the news and information that I receive to my specific concerns. Yes, there are privacy concerns here that are not insignificant. But if this data is going to be gathered anyway (and — unless you are both concerned and savvy about privacy — it’s being gathered right now), anything that could help better target health information is likely to be a boon.

Here’s an example: earlier this month, a large new study suggested that CT scans could cut the death rate from lung cancer, which is, far and away, the biggest cancer killer in this country, by 20 percent. Headlines screamed the good news. And the news was good, but only for certain populations: the study followed those between 55 and 74 who had a “30 pack-year” history of smoking: more than 1,000 packs over the course of a lifetime. For guys in that demographic, this is public health news of enormous proportions. For a younger, never-smoker like me that is outside of that group, information about the study is, personally, irrelevant at best and harmful at worst (if all the details aren’t made clear and I’m driven to seek screening). Scary as it seems to me at times, Google, Facebook and a dozen other sites are well-aware that I’m not a 55 to 74 year-old with a lifelong pack-a-day habit.

Better personalization might make the lung cancer study harder for me to find and other information — more applicable to my life — easier to find. The media and communications implications of this are important. While mainstream media often shy away from coverage of less-common conditions, more personalization means more demand for patient-focused content about specific diseases, therapies and issues. And that, in turn, means that publications such as CURE Today or MedPage Today will only grow in prominence. The trend toward the niche publication is only accelerating, and, short of a privacy backlash, the forces described in “The Filter Bubble” will only accelerate that.