At the Activate Networks Summit in Boston on Tuesday, a mix of social network scientists, pharmaceutical executives, academics and others convened to discuss the power of social influence, online and offline (but mostly offline). The key insight for pharma brand marketers, repeated by many speakers throughout the day, was that relationships of influence, not individual physicians, are where the big opportunities lie for changing behaviors. But how are those relationships identified and targeted?

By understanding the patient, or more specifically, who treats her/him. Instead of the timeworn tactic of purchasing a list of high-decile prescribers and spending a majority of the available resources targeting them, it’s better to start with de-identified patient claims data to determine “patient flow,” or which physicians have patients in common. From there, quantifying the level of influence between physicians based on how a patient is treated in toto leads to the identification of connections between physicians. “One physician may not write as many prescriptions, but if he’s the nexus of a network [between many other docs], that’s incredibly important,” said David Moore, senior group manager, marketing science at Genentech.

Colorful dot graphs abounded at the summit; Moore’s presentation featured a network graph of cardiologists, endocrinologists and primary care physicians, and the web of influence each physician spins. Smaller nodes or clusters of connected physicians (in terms of their relationship to each other in a social network) will often behave in very similar ways. For example, primary care docs are “reticent to change a therapy initiated by a specialist…they reinforce that regimen,” said Moore. By targeting the physicians with the most connections and influence, marketers can move the needle on a groups of physicians, without the need to use up resources on each individual. Homophily, or in other words, birds of a feather flock together, is common to all social networks.

There are many ways to gauge influence, and Activate Networks didn’t give out all of the secrets of its algorithms; influence is fluid and goes both ways, and harnessing the science of social networks means continuously looking at how physicians are treating patients over time, and how they interact with peers and colleagues. Pete DeWan, co-founder, chief scientific officer and VP analytics at Activate Networks told PharmExec that in addition to patient claims data, other criteria are also used to identify the strength of influence between one physician and another. But, he said, surveys prove that the insights gleaned from the company’s sociometric profiles of physicians are on the money, 80 percent of the time.

“Trust is a powerful tool for convincing someone to do something different,” said John Eichert, Principal at Rivermark, a marketing strategy firm servicing pharma and biotech companies. Without knowing who trusts whom within a given social network of physicians, companies won’t identify the right leaders, which means wasted dollars. Sales reps, for example, often choose the speakers and attendees for physician meetings, despite the fact that reps are “a poor judge of trust and leadership,” said Eichert. They get it right about half the time, he said. “Customers should identify speakers, not sales reps.”

The prevailing consensus of the summit was that social factors influence behavior, to a larger degree than most people recognize. By identifying the structures of social influence among physicians, and targeting the most influential docs, brand marketers can do more with fewer sales reps.

“Traditional market research about advertising is often wrong,” said Yadav, noting that his experience as an ethnographer put the fundamental tool of social science – self-reporting – into question. “I’d spend a lot of time with someone, and then give them a survey, and [on the survey] they were not the same person,” said Yadav. “People don’t have the ability to express emotion…if I ask how you feel, the response is how you think you feel.”

To bypass the speech/articulation process, Australia-based Neuro Insight uses steady-state topography (SST), which records electrical impulses in the scalp via a sensor-bedecked visor worn by test subjects. Put in front of a television and shown advertisements, subjects’ brain waves register their levels of “approach” or “withdrawal” from a given ad, which lets marketers predict the ad’s effectiveness, or adjust the content to prevent a dive into withdrawal. Neuro Insight has pharma clients – GSK is listed on the company website – but the case studies were limited to consumer brands, an unfortunate but familiar trend at digital pharma gatherings.

Moving from brain waves to search results, Steve Rotter, VP marketing at Brightcove, a web video hosting and service provider, cited data from Forrester proclaiming that “videos are 53 times more likely than text pages to appear on the first page of search results.” But the written word isn’t completely dead; Rotter said adding a transcript of a video to a webpage dramatically improves SEO and helps visitors find what they’re looking for more quickly. Brightcove has clients including AstraZeneca, Abbott, Genzyme, Roche and GSK, and is currently working on a platform for videos that senses which specific device is being used by the target consumer or patient, and optimizes or renders the video based on that device, said Rotter.

Doug Seifert, president and CEO at Syandus, an “experiential learning” company, demoed a COPD simulation game targeted to physicians. Created for Pfizer and Boehringer Ingelheim (the companies co-market the blockbuster COPD drug Spiriva), the demo was one of the most impressive displays at the conference. The game allows physicians to adjust variables and see how patients with different levels of severity or disease-state would respond. A doctor can make a patient smoke cigarettes and climb stairs, and then watch what happens in the body, for example. Seifert said simulations work because “humans are pattern recognition machines,” and “pattern recognition creates behavior change.” Besides, “endorphins are released” when people play games, a word Seifert defined as “a series of interesting choices.”

The conference ended on a somewhat hypocritical note, in that Facebook – “a distribution platform that promotes authentic sharing” – struck all sharing of its presentation from the record. Conference emcee Ritesh Patel, Chandler Chicco’s digital and social media lead, asked that all remarks from Facebook’s John Patten be kept within the walls of the Alexandria Center’s conference room, given the company’s upcoming IPO. As a result, the tweeters in the room (conference tweets can be found at #CCCDigital) were silenced for the duration.

By challenging physicians to be The SmartestDoc, MDLinx and the Cleveland Clinic are using competition to promote education.

Stephen Smith

On Tuesday, M3 USA’s MDLinx, a pharma advertising supported informational website for physicians, launched a new quiz – The SmartestDoc – for internal medicine and family physicians. In collaboration with MDLinx, the Cleveland Clinic is providing educational materials from its Center for Continuing Education to be used in the quiz, which tests a physician’s knowledge of recent medical literature, practice-related issues, and other med ed topics. While the quiz itself isn’t new, the Cleveland Clinic’s participation and provision of materials will bring new physicians into the competition.

The five-question quiz, which hopes to reach roughly 200,000 US docs in the first 90 days, allows registered physicians to quiz themselves once a day, and then see how their scores shape up against other physicians regionally and nationally. Anyone can take the daily quiz, and revisit past quizzes for review, but only verified physicians are included in the leaderboard. Each month, the doc with the most points will receive a certificate deeming him or her the “Smartest Family Physician.” Physicians can also form teams of five and compete against other teams. Quizzes are ranked by difficulty, and physicians can evaluate their strengths according to different practice areas. “There are performance pages – private to the physician – that measure expertise levels, and how they stack up against the community,” says Stephen Smith, chief marketing officer at M3, owner of MDLinx.

Smith says that content contributions from the Cleveland Clinic augment the quiz by giving it “a better blend…in addition to the new medical literature, there’s now enduring educational materials. It’s the mix of material that provides a robust learning environment.” Staff editors at MDLinx convert the materials received from the Cleveland Clinic into quiz questions.

As of now, the quizzes don’t offer CME credits, but Smith says he hopes to add this capability in the future. MDLinx has had preliminary discussions about integrating the quiz into live meetings as well as a certification review course, according to Smith.

A couple of years ago I spoke at a Life Sciences Forum organized by Oracle. The audience was 100-percent life science and IT professionals, but I spoke about the magazine business. Why? Cynics say because I don’t know enough about science or IT, but really it was more to do with the changes that the magazine market was facing and their relevance to the pharma market.

I won’t get into the woes of magazine publishers here. If you really want to know more read The Chaos Scenario by Advertising Age writer Bob Garfield, or if you don’t have time watch the You Tube video promotion of the book. Both book and video do a great job of describing the implosion of centralized mass media, the rise of digital alternatives and the growing importance of listening to what your customers want.

I only bring my presentation and Mr Garfield up because I was reminded of them by title of the keynote at the iPharmaConnect conference to be held in Philadelphia later this month. Pozen EVP Liz Cermak will be talking about Pharma’s very own Chaos Scenario: the revolution of the traditional pharma commercial model and how “the old model just won’t cut it.”

Liz Cermak says that pharma’s attempts to get brand’s in front of HCPs in any meaningful way, is becoming “highly unlikely” and “unappealing” to customers. Like Bob Garfield talking to dead-tree publishers, she calls on Pharma to “get with the program” and “fish where the fish are.”

Like so many magazine readers, HCPs have gone digital and the internet, not sales people, is their number one source for information.  And it’s obvious why — they can get information when they want it, where they want it and how they want it. Patients too.

No one is denying that the challenges in the digital pharma space are enormous, not least the lack of clear regulatory guidance. The good news is that, unlike a couple of years ago, when I was speaking to Oracle’s audience,  some major pharma brands are developing their digital IQ and are some real success stories out there for everyone to learn from.

Cernak sees the potential not just the problems. Putting her money where her mouth is, she has formed a digital advisory board at Pozen to bring in ideas from non-pharma brands like Pepsi and Walmart and from digital superstars like Marc Monseau formerly of J&J and Daniel Palestrant of Sermo.

The iPharmaconnect conference takes place in Philadelphia March 26th through 28th.

Peter Houston.

Aligning humanistic objectives with business incentives is often the sine qua non of effective community activism. This year’s Rare Disease Day – hosted in the US by the National Organization for Rare Disorders (NORD) – attempts to do just that. Some 630 patient organizations, government agencies, research centers and corporations have signed up to be Rare Disease Day Partners this year, and both the NIH and the FDA are serving as venues for events on February 29 and March 1, respectively, under the banner of solidarity.

A symposium for patients and researchers at the NIH will “focus on things that are really new and cutting edge in rare disease research,” says David Eckstein, senior health scientist administrator at NIH’s Office of Rare Disease Research. Topics include the utilization of stem cells and next-generation gene sequencing, and what that will mean for rare disease research. “We’ll also be talking about new research paradigms,” says Eckstein. “People have always talked about ‘bench to bedside,’ but it’s really bench to bedside and back; there’s a lot of information that flows from what’s learned in the clinic, back to the laboratory.” Topics will be targeted to a lay audience, to encourage patients and their families to attend.

During an extended lunch period, NIH hopes attendees will visit table exhibits and posters, and to interact with researchers and pharmaceutical companies. “We’ve opened up the ability of all these patient groups to advertise their existence and make others aware of who they are and what they’re doing,” says Eckstein. For the NIH Rare Disease Day agenda, click here (events and presentations will be streamed live here).

FDA, for its part, is hosting a Patient Advocacy Day on March 1. Dr. Gayatri Rao, acting director for the Office of Orphan Products Development (OOPD) at FDA, emphasizes the importance of collaboration – and solidarity – across stakeholder groups, as a means to solve the challenges posed by rare diseases. “Patient Advocacy Day will bring together patients and the different centers and offices within FDA that regulate products for rare diseases…with the goals of engaging the patient community, increasing awareness about translating research into therapies, and providing education on the roles and responsibilities of the FDA in the development process,” says Rao. For the FDA agenda, click here.

Outside of Washington DC, a slew of research institutions, community centers, local government groups and pharmaceutical companies are hosting their own events, from wine-tastings, film screenings and a marshmallow roast, to marathons, concerts and a virtual “Handprints on the Hill” campaign, sponsored by NORD, that will encourage participants to sign a letter to President Obama and members of Congress that supports rare disease awareness. To bring attention to specific cases of rare disease, every signatory can personalize the letter. In Europe, where Rare Disease Day originated in 2008, the European Organization for Rare Diseases (EURORDIS) will host and facilitate numerous events across many countries.

Pharmaceutical companies like Genzyme, Lundbeck and Biomarin have planned special events around Rare Disease Day. Mary Dunkle, NORD’s VP of communications, points to Genzyme’s “mini-marathon” scheduled for February 29. “Genzyme has a team of employees who run the Boston Marathon every year, to raise money to donate to NORD on behalf of all rare disease patients,” says Dunkle. “This year, they’re doing a mini-marathon…they’re going to be running some very significant distances at four different Genzyme facilities, and each facility will host a small program.” NORD will be on hand to distribute literature, and to speak on the Rare Disease Day theme of solidarity.

The “Raise Your Hand to Fight Rare Diseases” campaign, happening for the third year in a row, asks interested parties to visit NORD’s website and “Raise Your Hand” by clicking on an icon. For every click, Lundbeck Worldwide, the underwriter of the campaign, will donate $1 (up to $10,000) to NORD’s general research fund. Last year’s $10,000 donation went toward a research grant for systemic sclerosis, a rare autoimmune disorder affecting an estimated 49,000 people in the U.S. Silvia Laura Bosello is leading the study on systemic sclerosis, which is aimed at improving the identification of abnormal B-cells and administering medications that are known to positively affect the production of B-cells. Siren Interactive, a marketing firm specializing in rare diseases, is asking a network of clients, colleagues and friends to visit crumblymorsels.com and build a cookie to share online. For every cookie shared through Facebook, Twitter, Linkedin or Google+, Siren will donate $1 (up to $1,000) to EURORDIS and NORD.

Increases in the number and activity level of patient organizations in recent years have helped to spotlight the business opportunities for pharmaceutical companies. “I spoke with PhRMA recently, and they said that there are now about 460 rare diseases being worked on by the collective membership of PhRMA, which is the biggest number they’d had, ever,” says Peter Saltonstall, NORD’s president. “More and more of the large companies who have never been in the rare disease space are now making a commitment.” Eckstein says pharma has become more interested in creating niche areas for business. Quite a few [pharmaceutical companies] are realizing that it can be profitable to get into the rare disease market,” says Eckstein. “We’re doing as much as we can to encourage that, and to encourage patient groups to work with pharma, to ensure that clinical trials are well-enrolled, so that trials can be done quickly, which saves everybody money and gets things through the FDA faster.”

The Rare Disease Day theme of solidarity this year speaks to the importance – and benefits – of collaboration between patients and pharma. “If you take all of those rare diseases and total up all of the populations, there are about 30 million Americans that are affected by rare diseases,” says Craig Kephart, president of Centric Health Resources, a direct-distribution company focused on specialty pharma and orphan diseases. “By joining together these 30 million Americans, they make up a large group of people that need to be heard. We need to address effective and meaningful ways of helping them lead better lives.”

All-told the Mayo Clinic’s recent pilot study on clinical trial patient recruitment using social media and online networks not only helped researchers assemble large and demographically diverse patient groups more quickly, but also less expensively than they could through other means.

“This study is a prime example of patient-initiated research that could be used by other health care professionals and institutions,” conclude the authors of the Mayo report.

But can the Mayo Clinic’s pilot study really be used “by other health care professionals and institutions”? Was the success of their social media recruitment so easily translatable? Or was their pilot study the result of a perfect storm—a series of factors coming together to make it just the right opportunity for social media recruitment, and anything but commonplace?

What made it a Perfect Storm?
In an article in Digital Strategy & Patient Recruitment for Clinical Trials, Rahlyn Gossen examines key patient recruitment factors that resulted in the Mayo’s pilot study’s success and a perfect social media fit. A former clinical research coordinator who now has her own firm, Rebar Interactive, Gossen lists these six factors:

• Research focusing on a rare disease
• Concentrated and organized patient population
• Patient-initiated research and ownership for success
• Favorable demographics for patient recruitment via social media
• Widespread positive brand awareness (Mayo Clinic)
• Lack of geographic constraints

“In some cases, clinical research professionals can mimic the factors contributing to Mayo’s success,” says Gossen. “But in most cases, the possibility for successful social media recruitment will largely be the result of static factors like therapeutic indication, patient population, study design, and geography.”

“Before undertaking a social media campaign for patient recruitment, it’s imperative that clinical research professionals identify pertinent variables and determine whether those variables are well-aligned with a social media recruitment campaign,” says Gossen.

It is also imperative that whomever is behind the effort is equipped with the social media skills enjoyed by the Mayo Clinic (you only have to go to their website for a glimpse of their media expertise and sense of design). They must also be motivated by more than just a desire to sell a social media service.

“The reality is that, in many cases, patient recruitment via social media will be an uphill battle,” says Gossen. “But all is not lost. You can still recruit patients who frequent social media sites with advertising on those sites, thereby eliminating the challenges of patient recruitment on social media websites.”

Gossen told Applied Clinical Trials that it is important to distinguish between social media and advertising on social media platforms. “Social media is by nature a dialogue and requires a very different strategy and skill set than online advertising, which is more of a one-way broadcasting medium. An example of this distinction in practice is the difference between, say, putting up a Facebook page and conversing with those who are commenting versus putting up ads on Facebook. This distinction, I’ve noticed, is unclear regarding terminology.”

A tactical advertisement on Facebook, however, can be targeted among the site’s hundreds of millions of users. Its offerings for advertisers also can be highly targeted to specific geographic areas. And with such a large population, Facebook can reach a high percentage of potential patients across all levels of income and education. Traditional media can’t even touch those results.

Nevertheless, the uphill battle in social media recruitment was confirmed last spring by a survey conducted by Blue Chip Patient Recruitment. The study found:  Of 179 adults who were queried through postings in online health communities, 84 percent have never participated in a trial. Twenty-two percent would enroll if a drug offered a cure and 21 percent if they could help find a cure.

Online or offline, safety also presented an issue to the survey participants:

• 41 percent reported that trial safety is a primary concern
• 36 percent cited the credibility of the trial information found online
• 88 percent would prefer receiving clinical trial info online from a doctor

And when asked where they would first go to learn more about a trial:

• 46 percent pointed to doctors
• 24 percent said search engines
• 70 percent were comfortable receiving clinical trial messages from a healthcare association rep—the example offered was the American Diabetes Association
• 53 percent were comfortable hearing from an online support group
• 36 percent cited a live online chat
• 32 percent cited a website message board

For those invested heavily in the favorite social media sites:

• Fewer than 20 percent were most comfortable receiving clinical trial messages by way of a Facebook wall or a Twitter profile. Meanwhile,
• Only 30 percent were aware of key clinical trial websites, and
• Only 18 percent were specifically alert to ClinicalTrials.gov

In the end, using social media for patient recruitment is perhaps not so much an uphill battle as an exercise in strategy, discernment, and selection. It can work, it can even be an ideal method (as seen in the Mayo Clinic pilot study), but the particular conditions of the study must fit the social media opportunity, and not the other way around.

Those issues (adverse events, off-label discussions, fair balance presentation, no meaningful FDA guidance) hardly need rehashing here, and despite the barriers, progress has been made on the digital front, as evidenced by – if nothing else – pharma’s willingness to invest in smaller-scale social media efforts not directly tied to product sales. In the digital sphere, ROI means “hitting the primary endpoint,” and that endpoint could be data collection, engagement with widgets or functionalities on a page or within an app, or the number of visitors (or likes) on a Facebook page. “The ROI of social media is that your business will still exist in five years,” a quote from Socialnomics author Erik Qualman that surfaced in one of the presentations, speaks to the accepted necessity – in some quarters – of social media participation and customer engagement.

“Advertising has already largely shifted to what people say about your brand,” as opposed to the magazine, television and radio ads that people consume, said Martin Husar, customer strategy and innovation at Sanofi Canada. In Canada, DTC isn’t allowed, but last October Sanofi tapped the Toronto-based agency MediResource for an interactive Facebook campaign around atrial fibrillation (A-fib). The business objective, said Husar, was to “own the primary venues for Canadian patients and caregivers to learn about AFib.” By his measure, the company’s Afib at Heart | La fibrillation auriculaire à coeur Facebook campaign has been a success – one need not “like” the page to access the content, and thousands have clicked on tabs like “Ask the Expert,” or “Don’t Skip a Beat,” a Simon-inspired memory game.

A Janssen Canada educational campaign around psoriasis goes a step further, offering a list of available treatments, and a dermatology locator that returns only those dermatologists who “agree that they will use biologics” – Janssen markets Stelara, an immunomodulating biologic – and who have voluntarily signed up to be listed on Janssen’s Living Well With Psoriasis website, according to Spilios Asimakopoulos, director of marketing technology, Janssen Pharmaceuticals Canada. The site also offers a psoriasis “severity calculator,” which is available online or as an app for download.

South of the Canadian border, others agree that the educational/disease awareness space is a good place for experimentation. John Patten, a sales rep for Facebook, told ePharma attendees that “Facebook makes sense in terms of initial support groups [for rare diseases], and locating others with the disease.” He also singled out Bayer’s Walk for Hemophilia and Sanofi Pasteur’s Voices of Meningitis as good examples of Facebook educational campaigns. “Pharma is more powerful in the unbranded, open wall pages” on Facebook, said Patten. Whitelisted brand pages, or pages with the comments function disabled, will be “de-prioritized in the news feed,” and they go against Facebook’s model, which Patten defined as “a distribution platform that promotes authentic sharing.” Perhaps as an added nudge to discourage whitelisted pages, Patten announced that by the end of February, “admins can drill down into individual commenters, and message them directly,” to help deal with “your drug turned my arm blue” adverse events comments.

A couple of hours before Patten’s presentation, however, a regulatory affairs director from a major pharmaceutical company was on a panel griping about the fact that while Facebook allows blocking of comments on the wall, “we can’t turn off sharing or commenting” on the actual brand image. Asked whether the company responds to such comments on the branded Facebook page, the panelist said no: “once you do that, where do you stop?”

Energy. An active lifestyle. Mental and emotional stability. Absence of disease. Nutrition. These are some of the words and phrases that the public used to define “health” in the 2011 Edelman Health Barometer, released in October.

“What does it mean to be healthy?” Edelman posed this open-ended question to 15,000 respondents in 12 countries and captured, verbatim, the public response. “The public is redefining ‘healthy’ as ‘How I act, what action I can take, and what actions I do take,’ rather than just ‘how I am,’” explains Nancy Mensch Turett, global chair, Health, at Edelman. And increasingly, the barometer found, this less frequently means people’s perceptions of the environment and their dealings with the healthcare system, and more often their own lifestyle and nutrition choices. “And when we asked people who influences their health—their lifestyle and nutrition—the most, second only to themselves were family and friends.”

The implications of such a statement are far-reaching. It means that regardless what standards of health or beauty we see in Hollywood, which hot new fitness personality bombards us with ads, or even how many times our doctor tells us we should really drop a few pounds, what’s really going to influence our behavior and help spread the habits that make good health communicable is each other.

“We believe there is no such thing as a non-communicable disease,” says Turett. “All diseases are communicable, whether through viruses, bacteria, behavior, or a combination of these things. A key to the future well-being of the healthcare industry, but even more importantly to society, is to understand the communicable nature of all health.” For example, the barometer found that 31 percent of respondents will spend less time with a friend because of the friend’s unhealthy behavior. Additionally, according to study results, the idea of influencing one’s peers and driving communicable good health is a bigger motivator for maintaining one’s own healthy habits than personal gain—41 percent of respondents listed “realizing that the long-term health benefit of another person would improve” as their primary trigger of action in personal health advocacy. Another 28 percent listed their primary trigger as “making a personal commitment to help others.”

Turett compares being healthy to being “green” in that, like environmental consciousness, “the sustainability of our species depends on it.” Health is “the most personal of public issues and the most public of personal issues,” she says, and so “people are very attuned to brands’ and companies’ engagement in health. And from the standpoint of the pharmaceutical industry and the healthcare industry more broadly, this means that because your business is actually a social issue—one that people feel so personally and strongly about, and is such a big public issue from an economic and societal viewpoint—people in the business of health need to attend to the social as well as the business impact of their actions.”

Much like the “green” movement, the public in fact expects government, corporations, and healthcare stakeholders to be a positive influence. And despite the bad rep we sometimes believe pharma has earned for focusing only on the bottom line, the truth is, pharma is in fact a trusted authority whose input the public values—and expects—when it comes to health issues. “In our first study we saw that the public craves engagement from the brands and companies that are involved in health,” she confirms. “The public feels that being active in health is actually an imperative for businesses across the board. People are basically saying, if you want to be relevant to me and really make a difference in my health, you need to support lifestyle and nutrition. You can’t just come to me through other channels like the healthcare system.”

This year’s health barometer confirmed those findings, showing that all businesses are expected to engage with their employees and the public as a whole on health issues, through avenues such as education communications, public policy, philanthropy, partnerships, and innovation centered on spreading and encouraging healthy behaviors.

When you consider the heavy influence of peers on health today, the digital world can no longer be overlooked. Online health communities of peers—groups of patients with the same diseases and health conditions commiserating and collaborating together—are undoubtedly part of the peer influence in today’s “health 2.0” environment. And those in this multimedia space also agree that pharma has a rightful place at the table when it comes to making good health communicable. “Patients in these online communities are not cynical of pharma for the most part. I think this almost conventional wisdom that patients are skeptical or cynical of pharma companies—I don’t see that,” says Brian Loew, CEO of Inspire, which partners with nonprofit organizations to create and host online support communities for patients and caregivers in specific therapeutic areas. “You don’t see patients looking for bad guys and conspiracy theorists. You see patients who are saying, ‘I’m really grateful that I have these treatments. I’m trying to fine-tune it, I’m trying to find out what the best treatment is,’ but they’re incredibly appreciative of the therapeutic drugs that they are taking. And they overwhelmingly don’t have animosity towards the companies. I’d love it if we could debunk some of that, because I think people feel good about pharma companies.”

Catie Coman, director of communications at the National Psoriasis Foundation (NPF)—which has partnered with Inspire for a patient online community called TalkPsoriasis—agrees. “Patients look to the pharma companies and their websites for authoritative information. So, if I want to learn everything possible about what’s on the label for a psoriasis treatment, for example, I go to the manufacturer’s website. I think they look to pharma information as valuable reference material, at least based on what we see.”

Indeed, in a new study—ePharma Consumer 2011—released by pharmaceutical and healthcare market research company Manhattan Research, 42 percent of online consumers agree that pharmaceutical companies should be involved in online health communities for consumers. The study, of 6,643 U.S. residents ages 18 and over, also found that 39 percent of online U.S. adults visit pharma prescription drug websites, and 35 percent visit pharma corporate websites. Clearly, the messages pharma chooses to send matter, and in fact consumers are looking for more, not less, input from pharma. “We asked online consumers about their use of and interest in various types of online information and tools from pharma companies. The results revealed that there is considerable unmet demand for disease management support (online tools or information to help manage a condition) and consult preparation (guide or tools to help prepare for a discussion with a doctor),” Manhattan Research told Pharm Exec.

“Pharmaceutical marketers and communicators who are looking to really create communities of health, and to support not only the healing but also the prevention of unnecessary progression of disease, really should be looking at the social unit and not just the individual,” says Turett.

In 2011, the patient’s clout as a stakeholder was firmly established, as reflected in several industry conferences. What’s next for the patient in 2012?

In 2011, many healthcare organizations came around to the idea that patients should be included in discussions that had customarily taken place about them, but without their direct participation. This shift was evident at several healthcare conferences last year, and bodes well for 2012 as a year when further overtures – and partnerships – will be formed with and between patients.

Health2.0

The Health2.0 conference in San Francisco brought a deluge of innovation and shiny, new healthcare applications. Data plus IT and innovation represent the future of healthcare, and individual patients are a critical component of this equation (not just their data). This was a key theme of the Health2.0 conference. “Patient stories” have often been highlighted at conferences, and used as bookends to infuse a dose of reality to educational sessions.  What impressed me about the Health2.0 conference was the inclusion of patients and caregivers in the conversations, allowing for bi-directional exchange. Patients2.0, an offshoot of Health2.0, is a movement that aims to revolutionize healthcare delivery around the patients. The goal is to leverage the Health2.0 phenomenon and develop a hub for patients to exchange experiences through peer-to-peer networks, to obtain information, and most importantly, to have a collective voice in healthcare decision-making. By sharing stories, co-creating health data, and aggregating issues across the healthcare spectrum, the voices of Patients2.0 are empowered to be part of the larger conversation, and to exert influence on the health system by shaping future policy. Patients are the new healthcare disruption that can help transform the landscape, and using forums such as Health2.0 to involve them every step of the way is truly ahead of the curve.

Epatient Connections

The key theme at the Epatient Connections, held in Philadelphia, was that “Healthcare is Social.” Physician, medical and patient communities are forming connections through various social media channels, but there are a still a few less progressive entities a step behind as they figure out how to navigate uncharted regulatory waters. As connections are made, patients are becoming further engaged in their care as they learn from what others are doing. The key is to take those connections one-step further and bridge the various pockets of connection. There needs to be further inter-connectivity between patient voices, scientific publications, medical results and records, and medical education geared towards healthcare professionals, and these need to set the stage for a longitudinal data set. Patient engagement tools that were showcased included everything from health management tools to game-ification that integrated feedback mechanisms and incentives to an Internet enabled robotic telepresence, allowing immobile patients to interact with their healthcare community.

SXSH Unconference

The SXSH Unconference also took place in Philadelphia (Sharing, Exchanging, Social Health). Todd Park, CTO, US Department of Health & Human Services opened up the conference with an introduction to the Data Liberation initiative: New Incentives+ Information Liberation= Rocket Fuel for Innovation. Medicare, Medicaid, and the Veteran’s Administration represent the largest repository of public health data in the world. Patient data liquidity and information about the public health, stripped of personal identification, is being made available so that innovators can use it to create health-maximizing options.

2012

2011 was a year where a foundation for the “patient voice” was established as a critical component of the healthcare system. 2012 will be an even more important year, as healthcare organizations empower more patients by personalizing communications for individual patients. Patients are often overwhelmed with the amount of information they must retain to successfully manage their health. How will healthcare organizations come together to simplify navigation of the healthcare system? How will different healthcare systems, records and applications that serve different purposes connect with one another to prevent redundancy? How will patient stories be further synthesized and culminated into “patient issues” that a roundtable of healthcare sectors can further troubleshoot at future conferences? If 2011 was the year of dipping toes in the waters of “patient engagement” …2012 should be the year of swimming alongside others towards a unified goal—a year of patient engagement through an open network of inter-connectivity.

Sarah Krüg is CEO/executive director of CANCER101, a patient outreach and advocacy organization. She is also president-elect of The Society for Participatory Medicine.

In response to off-label inquiries about a drug, biopharma companies can use the kind of boilerplate they’ve been inserting on social media sites for years – thanks for your comment, here’s our contact information, call us for more information – but they cannot address the question publicly, where it appears, a privilege many hoped would be included in FDA’s long-promised and long-awaited social media guidelines. Companies must also include a “mechanism for providing readily accessible current FDA-required labeling,” but cannot include a link to anything that could be construed as promotional, like a “product website, product promotional materials, firm websites, or third-party websites.” Guidance on responding to unsolicited requests for off-label information was published in the Federal Register a few days before the end of 2011.

Responding to an unsolicited off-label question/comment is only appropriate when a specific brand is named, and if the question is “broad in nature,” drug companies should “appropriately narrow the question.” FDA recognizes the fact that companies are “capable of responding to requests about their own products in a truthful, non-misleading, and accurate manner,” and that companies probably know more about their own products than other self-appointed responders:

It can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information.

Unlike other forum responders, who can comment publicly in response to any question, manufacturers must wait for the original commenter to respond to the boilerplate message with contact information, before providing “any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question,” and that communication must occur “solely between the firm and the individual who made the request…the firm should not make its detailed response with off-label information publicly available within the same forum.”

FDA’s guidance on industries’ social media interaction with patients, at least with respect to off-label inquiries, seems to be: Don’t participate publicly. According to the guidance document, this sentiment reflects a concern that publicly posted off-label information – in response to an unsolicited query – would be available for an indefinite period of time, and would also reach the eyes of readers who have not requested such information. Even if the drug information is accurate when it’s posted, it may not be accurate next month. For viewers who didn’t ask about an off-label use, but are still party to a public response, the information itself, regardless of its scientific merit, “may promote a product for a use or condition for which FDA has not approved or cleared.”

Those companies that would like to respond to an individual with a question, assuming that person has called or emailed the company in response to the provision of contact information – contact info that leads to a firm’s medical or scientific department, not a marketing department, the guidance clearly states – should include the following materials, according to the document:

• FDA—required drug label
• A prominent statement saying the product has not been FDA approved
• A prominent statement disclosing approved indications, if any
• A prominent statement of all important safety info, including box warnings, if any
• A complete list of references for all of the information disseminated in the response (firms should use peer-reviewed articles whenever possible)

Companies should also maintain the following records about off-label responses:

• The nature of the request for information, including the name, address and affiliation of the requestor
• Records regarding the information provided to the requestor
• Any follow-up inquires or questions from the requestor

The guidance is open for comment for 90 days. Here’s the Federal Register entry.