“Sermo Mobile allows members quick and easy access to the knowledge and expertise of leading PCPs and specialists throughout the country, anytime, anywhere,” says Daniel Palestrant, M.D., founder and CEO of Sermo. “Turning the concept of real-time medicine into reality has been our vision for some time, and this technology allows physicians to immediately impact patient care.”

Using iConsult, physicians can take or add a photograph of a physical finding, x-ray or laboratory result, choose a suitable question from the list available and then immediately send it to relevant specialists in the Sermo network. Members can view and respond in real time, offering unparalleled access to shared medical expertise. Sermo is the largest online physician community in the United States, with more than 120,000 physicians spanning 68 specialties.

Other features of Sermo Mobile include fast, easy access to Sermo discussions about clinical cases, practice management, healthcare reform and more; anytime, anywhere access to the Sermo community to ask questions or share opinions; ability to author and track posts directly from a mobile phone; and notifications that keep members informed of the most recent developments in medicine

Working in close collaboration with physicians across the country, Sermo identified an increase in mobile use in clinical settings, and the need for a mobile app to complement its online service. Sermo Mobile is available for the iPhone, iPod Touch and iPad. A partner of Janssen Global Services, LLC, Sermo will continue to develop and deliver additional real-time services that will help physicians provide more efficient and enhanced care to their patients.

(See the August issue of Med Ad News for information about another technology initiative Sermo has launched, aimed at oncologists.)

“Facebook’s recent policy change really sparked a ripple of concern from marketers and communicators in the industry,” says Faruk Capan, CEO, Intouch Solutions. “But we believe, in many instances, pharma companies can and should continue to engage with Facebook members. The key is to combine a moderation tool like PharmaWall with monitoring services, so conversations are relevant to the Facebook community yet safe for the regulated environment. We’re happy we can leverage technology to help companies engage while minimizing exposure and risk.”

According to Wendy Blackburn, executive VP at Intouch Solutions, PharmaWall allows companies to take control of the conversation and still allow Facebook comments.

“It gives you a filtering ability that Facebook kind of let you used to have, but now they’ve taken that away, essentially,” she says.

If a Facebook member posts on the Wall, or comments on a post, they get an automatically generated message that thanks them for their post and lets the know that their post is in moderation and will be responded to as quickly as possible. Ms. Blackburn says the client can customize the outgoing message to their liking.

Clients are recommended to set up a system in which they can review these posts “almost near real time,” Ms. Blackburn says, but the function does take into account that companies are usually not able to spare people to monitor a Facebook page 24 hours a day, seven days a week. PharmaWall gives companies the chance to consider whether a post is benign and can be put up right away, or potentially violative, or mentions an adverse event or an off-label use.

“If it’s something that’s never going to get posted, we recommend contacting the person and letting them know why,” Ms. Blackburn says.

Although Facebook does allow comments to be deleted retroactively, “It makes you look bad and it requires almost 24-7 monitoring of that page, which very few companies are set up to do,” Ms. Blackburn says.

As well as all posts, PharmaWall retained copies of decisions to approve, revise or decline are documented for later review.

PharmaWall has gotten a great deal of interest, not only from Intouch’s clients, but from other healthcare advertising agencies as well, who want to offer the tool to their clients, Ms. Blackburn says.

Ms. Blackburn says if FDA ever does come out with a guidance that says pharma companies are not responsible for user-generated content on their social media sites, the need for tools such as PharmaWall would ease. But until such a guidance comes out – if it ever does – pharma will assume that it is responsible for user-generated content and will take steps to control it.

The license for PharmaWall is about $1,000 a month, Ms. Blackburn say, relatively inexpensive compared with a monitoring service. But a company can still choose to hire Intouch to monitor the Facebook page.

About 15,000 physicians from 22 specialty areas responded to the online survey, which was fielded in February, to better understand physician compensation and productivity trends. Medscape has published the Physician Compensation Report for 2011, which includes the full survey and feature coverage, on its Web site.

“Medscape’s first annual physician compensation survey highlights the significant compensation gap between specialties, with pediatrics and adult primary care on the lowest rung of the income ladder,” says Dr. Steven Zatz, executive VP, WebMD Professional Services. “Responses from WebMD’s physician community also highlight that a gender gap still exists in medicine. However, regardless of the disparities in compensation, the results also highlight that nearly 70% of physicians surveyed said they would choose medicine as a career if they had it to do over again.”

While the demand for primary care doctors continues to grow, specialists still earn the most money. Primary care physicians earn less than other specialties with average annual incomes of $159,000. The disparity is most evident when primary care compensation is compared to the top three earning specialties: orthopedic surgeons and radiologists both at $350,000 and anesthesiologists at $325,000.

Among the 15,000 physicians surveyed, men earned more than women across all specialties. For all physicians, females earned a median of $160,000 while males earned a median of $225,000. The same held true among primary care doctors, where female physicians earned $140,000 compared to their male counterparts who earned $170,000. The wage gap is likely a result of a variety of factors, but the survey revealed that the number of hours worked and the chosen specialty contributed to the lower pay. Female physicians spend fewer hours per week seeing patients than male physicians; by a two to one margin, women are more likely to spend less than 30 hours a week seeing patients. In addition, fewer women are represented in higher-earning specialties.

Physicians working in larger practices with 100 or more physicians earned a median of $167,000, when compared with solo physicians who earned the least, at a median income of $144,000.

Physicians not only spend time with their patients, but also spend a good part of their work week on other professional activities. Our survey finds that most doctors devote hours to paperwork, clinical reading, administrative and supervisory work, and other professional activities each week. Looking at primary care physicians in private practice, 31% work from 10 to 14 hours per week on non-patient activities, while 22% of employed doctors put in that much time on non-patient work.

So it was no surprise to see the results of a survey forwarded to me by Wendy Blackburn, VP at InTouch Solutions Inc. InTouch, via The Harrison Group, had surveyed physicians in March on how they preferred to receive product information and found that:

• More than one third had received an iPad detail from a pharma sales representative

• Of those that had received an iPad detail, 68% reported being extremely satisfied or very satisfied with the format

• 8 in 10 rated digital detailing (iPad, iPhone, iTouch, Tablet, etc.) as the same or better than previous methods such as paper-based visual aids

• Significantly more physicians who had been in practice 20 years or less believed digital detailing was better than previous methods such as paper-based visual aids.

• The opposite was true for physicians in practice more than 20 years, who were more comfortable with paper-based details.

So yes, iPads are on whole welcomed by most doctors. But it seems that the iPad or whatever digital detail platform is used still needs a real human being presenting it. In the most recent edition of Med Ad News’ DotPharma e-newsletter, new research indicates that doctors are seeking a combination of digital and face-to-face detailing.

This research, conducted by Knowledge Networks using the Physicians Consulting Network, shows that doctors are seeking a combination of digital and in-person marketing. Although specialists and primary care doctors are increasingly relying on smartphones and tablets to check email, research medications and conditions, and take online surveys, they still prefer in-person visits with drug sales reps over electronic pharma marketing, or e-detailing, by a factor of 3-to-1.

Drawing on responses from 5,490 doctors, the 2011 Digital MD Marketing research shows that:

• 67% of PCPs and 61% of specialists now have a smartphone (64% of doctors overall)
• 27% of PCPs and specialists alike have tablet computers (such as iPads) – about 5 times the level in the general population
• Shopping and survey taking via mobile devices have grown significantly since 2010, but “e-detailing” grew less dramatically and is less common
• Reference applications, such as Epocrates and WebMD, are the most popular mobile medical “apps” – while apps from pharmaceutical manufacturers receive minimal use

Additionally:

• 79% of primary care doctors and 74% of specialists prefer in-person dialogue with reps; physicians ages 55 and over skewed higher on this answer by 12 percentage points, compared to those under 40
• 23% of primary care doctors and 28% of specialists prefer computer-based e-detailing; physicians over age 55 viewed this method only slightly less favorably than did younger physicians

Something hopeful also showed up in this research:  61% of primary care doctors and 50% of specialists still maintain an open-door policy when it comes to sales rep visits – compared with those doctors who insist that sales reps make appointments or who do not see reps at all.

So to answer the initial question, to iPad or not to iPad, the answer is a “yes” – so long as the physician is younger and there is a trusted sales rep to engage the conversation.

So, if the leading and most competitive technology companies can find productive and transparent protocols to collaborate, why can’t the same principles apply to professional medical education? This is the question posed by Frank Britt, president and CEO, M|C Holding Corp., the owner of Pri-Med. Pri-Med is a leading provider of professional education solutions to a community of more than 235,000 primary care clinicians.

Toward that end, yesterday Pri-Med launched a new initiative called the Pri-Med Open Network designed to spur industry-wide innovation in all aspects of professional medical education and continuing professional development. The goal of the Pri-Med Open Network is to enhance the learning process by establishing a new, more decentralized network of clinical educators and content experts, and a highly engaged, collaborative community of physician learners across channels and geographies.

Through the initiative, Pri-Med will work with partners throughout the medical education provider and healthcare system to develop new approaches for sourcing and creating course content. In addition, Pri-Med will expand the models it currently uses for funding education to include new models that draw on an array of potential supporters, including non-profits, academics, government agencies, and professional organizations.

Mr. Britt sees medical education undergoing a similar paradigm shift as the one taking place within the realm of higher education, which has moved beyond the traditional walls of academic institutions.

“The demand for flexibility and cost-efficiency combined with the onset of new technology vehicles has ushered in a new era of higher education that is both peer-produced and open sourced,” Mr. Britt told Med Ad News. “As a result, virtual and online learning models now play a much larger role in the higher education landscape. We see these trends influencing medical education as well, and we want to help lead these changes in a way which capitalizes on the convergence of live, online, and virtual learning in medical education, and the rapid rise of online social networks for physicians.”

Pri-Med believes that these trends will accelerate in the years ahead, driven by several converging imperatives. These imperatives include evolving physician learning needs requiring innovation and expansion of engagement platforms; enabling better dialogue between and among front-line physicians, both in the United States and globally; recognizing the emergence of team-focused care delivery and cross disciplinary collaboration that extend to patients’ in-home care; sourcing and creating content to meet the diverse needs of today’s physicians, drawing upon the depth and breadth of resources and knowledge across the healthcare spectrum in order to provide comprehensive, relevant and measurable educational offerings; expanding the range of appropriate funding models and sources to reflect a range of stakeholders including government, managed care, and employers; and redoubling efforts and expanding third party involvement in addressing and monitoring the appearance of conflict and the call for best practices in regulatory adherence and transparency

In regard to that latter imperative, Pri-Med recognizes that there is a perceived bias associated with industry-supported CME. “However, the fact is that there continues to be concerns about ‘perception’ and ‘potential’ impact of financial relationships on the conduct and delivery of CME without evidence of any such negative impact,” Mr. Britt says. “In fact, the peer-reviewed literature demonstrates the exact opposite – the benefit of CME without commercial influence. We believe this is a narrow, but important issue, and we should, no doubt, continue to re-double efforts and expand third party involvement in order to address and monitor the appearance of conflict. However, we need to focus on moving forward in driving innovations in CME in its many formats, iterations, topics, and clinical gaps to better meet the needs of primary care physicians and their patients.”

The first components of the Pri-Med Open Network are already under way with initial content partners, including specialty medical societies seeking to expand their reach into primary care, regional academic centers seeking to broaden the reach of their educational efforts, and other organizations that have information to share and would like to connect with clinicians.

As future business leaders, today’s children are primed to work and collaborate in a real-time, 3D virtual setting. ProtonMedia is laying the groundwork for that future as the developer of ProtoSphere, a virtual social environment in which users’ computer avatars can meet for online teaming and collaboration. ProtonMedia’s customers include such life sciences companies as AstraZeneca, Johnson & Johnson, and Merck.

Although Ms. Kittrel acknowledged that as of now, interest in the possibilities of virtual collaboration far outstrips actual adoption, as her examples demonstrate, for the next generation of life sciences CEOs, researchers, and sales people, a second life will be second nature.

Microsoft’s Sam Batterman, who goes by the title “business intelligence evangelist,” spoke today about how these virtual collaboration environments function as far more than just the “N” drive on a company’s network. For example, in addition to document and application sharing, ProtoSphere provides the tools teams need to collaborate socially online, including holographic virtual spaces with interactive avatars and bots, VoIP audio conferencing, text chat, presence awareness, video streaming, blogs, wikis, feeds, role-playing simulations, content workflow, and enterprise social networking. For the life sciences industry, Mr.  Batterman suggests uses such as constructing virtual data rooms, a chemistry plaza, or innovation and ideation networks.

The big question is, why do all this in a virtual environment? Why transform the collaboration companies do every day into a massively multiplayer online role-playing corporation? The answer, according to panelist and ProtonMedia CEO Ronald J. Burns, is that in a virtual collaboration environment, it’s not just the charts and graphs and documents housed in the online environment that have value; the avatars themselves have value. The skills and expertise held by the real-world personalities behind the avatars are available and accessible.

But that’s not the only reason, according to panelist Tony O’Driscoll, a professor of the Practice of Business Administration at Duke University. He believes that virtual collaboration online represents the third generation of the Web, the point where the user is enveloped within the content.

The author of Learning in 3D: Adding a New Dimension to Enterprise Learning and Collaboration, Mr. O’Driscoll highlights the value of learning in 3D environments with the equation I x I = E. That is, Interactivity times Immersion equals Engagement. His research has found that bringing people together in virtual learning environments can have a positive impact on the learner’s engagement with the material. According to Mr. O’Driscoll, learning leadership is not only possible in the virtual environment, it’s an ideal venue in which to do so.

In the gaming world, roles change quickly and decisions must be made rapidly, on the fly. Gamers must assimilate numerous sources of input to develop strategies and put plays into action. The gamer must then quickly develop new skills in order to advance through the game. The same principles of learning, advancement, and reward can be transferred to the business world, according to the proponents of virtual 3D collaboration technology.

Before virtual collaborations can gain traction in the business world, however, a critical mass will need to be reached of senior leaders ready to adapt to new technology, according to panelist Tom Kaney, managing partner, MKP Partners.

It may just be a matter of time. Today’s 13-year-old 7^th level mage fighting orcs in Azeroth is tomorrow’s pharmaceutical sales rep or oncology researcher. She’ll be ready to bring the power of virtual collaboration to the workplace, if companies like ProtonMedia don’t succeed in getting there first.

“You reach a critical mass in the market where market leaders are using autoinjector technology, so new entrants to the market have to come up with at least equivalent – if not better – technologies to allow them to compete in the marketplace,” Mr. Reynolds says.

In April, Centocor Ortho Biotech Inc.’s Simponi received FDA approval as the first once-monthly anti-TNF for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The drug was the first subcutaneous anti-TNF to launch with three rheumatic indications simultaneously and with the novel SmartJect Autoinjector.

The Simponi SmartJect is a novel autoinjector designed to meet the needs of arthritis patients that has received the Ease-of-Use Commendation by the Arthritis Foundation.

In 2006, Abbott Laboratories launched the Humira Pen to help make self-injecting simpler and less painful for patients. Humira is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. The product is also used to treat Crohn’s disease after other drugs have been tried without successful treatment of symptoms.

Drug companies are beginning to consider the use of autoinjectors earlier in the drug-development process than before. Companies are beginning to have the intent to launch the product with the autoinjector, which means that they have to start the evaluation and the development work very early in the drug cycle, typically in Phase II development of that drug. This is important because there is a critical connection between the autoinjector or the delivery device and the drug container. The drug container in most autoinjectors is a prefillable syringe that has to be compatible with the autoinjector and has to function effectively to be able to give the dose every time repeatedly without any adverse effect on the drug or the device.

“What that means is that a pharmaceutical company or a biotech company should be thinking in Phase II studies if they’re going to go to an autoinjector they need to be evaluating the compatibility of the syringe or the autoinjector at an early stage,” Mr. Reynolds says.

For a device to be successful, patient needs with regard to training tools and support must be met. The needs of the end-user will determine the size of a device, how it should look, and how it should feel. This kind of information provides marketers and their partners with good information to train individuals and give support in using the device.

Many pharmaceutical provide online support for patients after the launch of a product. Pharmaceutical companies, their vendors, and advertising agencies are working much closer now than before, and some industry experts believe there is a lot of opportunity for more collaboration between the device manufacturer, the drug manufacturer, the patient population, and the branding people who position the product.

“In an ideal world you’d have a strong collaboration with all the aspects right back from the device manufacturer or the drug manufacturer or the marketers and more importantly, the patient, to figure out how we can all help them to make the injection experience much more compliant, but also easier,” Mr. Reynolds says.

SimponiOne Support is an online support solution developed for people receiving treatment with Simponi and for healthcare professionals. Patients have access to cost support, nurse support, and safe returns for the proper disposal of used SmartJect autoinjectors. Medical practices trying to figure out insurance billing for Simponi can use AccessOne, an integrated service for Simponi benefits.

Abbott’s My Humira provides patient support for the Humira Pen and prefilled syringe. At the Website, patients have access to injection instructions and a video, a kit to get started, the ability to talk to a nurse, information about Humira Pen and syringe disposal, medication reminders, and tips from the myHUMIRA Panel comprising of individuals living with autoimmune conditions. The company provides detailed transcripts and visual guidelines throughout the site, such as this Humira Pen diagram below.

Autoinjector and prefillable syringe technology continues to evolve. West Pharmaceuticals has developed ConfiDose, a disposable autoinjector designed for prefillable syringes, which can be glass or plastic. A patient carries out three steps with ConfiDose, which requires them to first remove the cap, then twist the device to release the safety mechanism, and then place it on their body in the appropriate point of injection and hit the button. During the process, the needle is inserted, the dose delivered, and at the end of the dose the needle retracts.

“The needle is completely hidden both before and after injection, which we find to be a key factor when you’re talking about needle phobia and pain of the patient and also safety in terms of encapsulating the needle after use,” Mr. Reynolds says.

West’s Confidose technology allows more novel high-viscosity drugs to be injected in a reasonable period of time, without the risk of damaging the syringe or incomplete dosing. The drug is prepackaged in the device, which is a barrier to counterfeiting.

Editor’s Note: Watch for the January issue of Med Ad News to read more about marketing and branding in the therapeutic area of autoimmune diseases, and check out the February issue of Pharmaceutical and Medical Packaging News to read more news about the use of autoinjectors in other therapeutic categories.

My full conversation with John Kamp follows.

Med Ad News: What was your assessment of the industry’s performance Thursday and Friday?

John Kamp: I thought it was pretty good. The regulated companies and their trade associations actually stepped up. Several companies – Pfizer, J&J, Sanofi-Aventis, Lilly – all had pretty good testimony. I was particularly pleased that PhRMA was able to put a specific proposal on the table, and it received a lot of discussion. They were essentially trying, as we were, to get some discussion around ways to get the FDA regulated communication more easily available to consumers and others, and I thought it was a positive step to make that proposal. AdvaMed was also there, very serious about their matters. The media were there. So, I think it was pretty important. One of my colleagues [Peter Pitts, of the Center for Medicine in the Public Interest] called it the Super Bowl of Part 15 Hearings, and I think that might be right.

Med Ad News: Do you think it was a generally fairly unified voice, or were there dissenting opinions?

John Kamp: Unified voice? No. We’d all be suspicious if that were the case. But not so much dissent. People had different ideas. The industry and even the consumer groups did coalesce around some basic ideas, and one of those would be that FDA must enable companies to more aggressively operate in this space. That FDA shouldn’t expect that individual drug, device, and bio companies can control everything on the Net, particularly what goes on in the social media space. That instead it ought to be that if you’ve got control, then you’ve got responsibility, and you must take that control when you’ve got it. But if you don’t have that control, you don’t have responsibility. There were quite a few ideas about how to, in effect, develop a one-click away or a solution that more effectively enables companies to do the best they can to get people to read the contraindication information. So, there was a lot of agreement, I think.

And I was impressed that FDA – although this is a Part 15 hearing where they can’t telescope or make policy –asked some awfully good questions. They were listening, but it was active listening. And I was impressed by both the care with which they listened, the kind of questions they asked. These lead me to believe that they’re paying attention. They know they can do better, and they are going to.

Med Ad News: That’s an interesting point you raise, because like you said, they weren’t there to talk, they were there to listen. But in terms of the questions they were asking, can you give me a sense of the issues that seemed to be important to them or that registered with them enough to question?

John Kamp: Well, we can just use the PhRMA proposal that there be some kind of device on banner ads that enable people to immediately go to the contraindication information. They asked a lot of questions about it. My guess from it is that although the idea of doing this was one they thought was interesting, the idea of making it an FDA related icon is a non-starter. But doing something like that, I think they’re taking it into serious consideration or they wouldn’t be asking the questions.

Med Ad News: So, in general, a productive couple of days?

John Kamp: Yeah. I think FDA is likely to make some things clear. None of us expect, as one of the speakers put it, to see a package to industry under the Christmas tree with a new policy in it. Things like that don’t happen in the government. But there were a couple of things that the people asked for that the FDA has already been pretty clear about, and I think they can continue to be pretty clear about that.

One of them is this whole idea that, although there is a lot of concern in the industry that they might be held responsible for things they don’t control. I’ve never heard the FDA say that. And I expect them to say that that’s not the case in public speeches. The adverse-event reporting stuff is not an issue of DDMAC for the most part. It’s being driven by company lawyers. But for FDA to be real straightforward about that there’s no expectation that companies be responsible for things that clearly the responsibility of the individual people on the Net who are using their browser or that they somehow stop things from being put on the Net by third parties; they’ve never expected that. For them to say that straightforwardly, I would expect to hear very soon.

Med Ad News: Even prior to some kind of official guidance?

John Kamp: Yeah, I think they’ll be more straightforward. Not so much DDMAC staff, but Bob Temple, who is very important in these areas, has been talking very openly and straightforwardly about the adverse-event reporting stuff and telling companies, “Stop telling us all this information that’s not useful.

Med Ad News: Why do you think FDA did this now, as opposed to years ago? Is it just because they’ve finally caught up, or does it have to do with the change of administration?

John Kamp: There is a growing realization that the Net is a different medium and needs specific focus and understanding. I think for the most part this was probably considered and planned well before the election, frankly. Did everybody check with their new bosses before they went forward? Yeah. People do that. But I think it’s just a growing realization that they need to pay attention.

Med Ad News: The time had come.

John Kamp: Yeah. And maybe we wish it had happened earlier, but it didn’t. But now that it’s here, let’s embrace it.

I recently had an opportunity to speak with brand strategy consultant Rob Frankel, and he offered an interesting perspective on the pharma industry’s approach to branding and how a different mindset could help protect brands even after generic competition hits the market. The key is to create well-managed online communities to build loyalty, trust, and investment in the pharmaceutical brand.

You may have seen Mr. Frankel on the NBC Nightly News with Brian Williams, Neil Cavuto on FOX, CNN, FOX Business Channel, or CNBC. He’s also the author of The Revenge of Brand X: How to Build a Big Time Brand on the Web or Anywhere Else and the founder of i-legions a division that takes businesses’ user bases and monetizes them into revenue-generating “Branded Communities.”

According to Mr. Frankel, the pharma industry’s approach to branding is all wrong. From the minute a drug hits the market, companies are playing beat the clock before the product’s patent expires. Little thought is put into building brand loyalty with the consumer.

“The whole brand discipline thing doesn’t even occur to them,” Mr. Frankel says. “Once it’s tested, once it’s FDA approved, screw it. Pay the check, give the millions to the ad agency. Just get them to sell it. Get the sales force out there. Let’s go back to research and see what else we can stick in the pipeline. It’s a very short-term strategy. And a lot of this stuff has reverberations all the way down to Wall Street.”

If patients can be made to become invested in the brand, fall off due to generic competition will continue, but not at nearly the rate that happens now.

The question is, how do you motivate people? How do you mobilize them? And then how do you get them to be brand loyal and eventually drive brand revenue as a result of that? But according to Mr. Frankel, these questions are completely outside the perspective of pharmaceutical marketers.

“Pharma companies are probably the most fortressed, least brand conscious, and certainly the least sophisticated when it comes to brand strategy of most of the sectors out there,” Mr. Frankel says. “When you couple that with a not-invented-here mentality, you get a real fortress type of entity that simply wants to churn out whatever they can as quickly as they can before their patents expire.”

The first thing that the pharma companies would have to do is be open to and accept the validity of brand strategy into their model. Branding is about more than identity and loyalty. Marketers need to position each brand so that it is perceived as the only solution to the prospect’s problem.

“When you brand like that from the outside in, now instead of saying, here, recommend this drug, it works, now you’re saying here’s a couple reasons why you’re not going to want to go anywhere else,” Mr. Frankel told Med Ad News. “You start engaging in a lot of two-way dialogue with what I like to call a support mechanism called ‘brand community.’”

Two types of communities are needed. One would be a closed community, for doctors. And one would be an open community, for the public.

“They would be able to say to doctors, look, all these people are having trouble with diabetes; we’re hearing them,” Mr. Frankel says. “We have an open forum for them. We have a brand community so that these people can talk to each other. These people are asking for what we’re giving them.”

This action will take the pharmaceutical marketer from being not just an authority on the product and disease state, to possessing the credibility and clarity needed to earn physicians’ trust. “The authority they have as the drug company that manufactures and researches [the product],” Mr. Frankel says. “But the credibility comes from their actions.”

Many marketers are taking forays into creating online patient communities. But Mr. Frankel doesn’t put much stock in the efforts to date. “Everybody who is attempting to do community is doing it wrong; I mean seriously wrong,” he says. “A branded community is not at all about technology. It’s about management. It’s authority, credibility, and clarity. A community has to have authority. There has to be an agenda. Somebody has to be there actively managing it. Visually managing it. And then once they have that person, that person has to know the right things to do and the wrong things to do because you’re managing a group of people. Every other community out there basically is a glorified bulletin board. Put your comment in here and then have it tracked or repeated on Twitter or Digg or whatever. That doesn’t do squat. And the reason it doesn’t is it’s not driven by a brand strategy.”

What’s the brand strategy? Eventually, it’s to bring people into the fold and drive revenue. But people don’t do that on their own, Mr. Frankel cautions. They have to be brought in, told what’s expected of them, managed, encouraged to interact, and instructed how to stay within regulatory boundaries and on topic.

“You’re going to say, look, here’s the deal, if you guys start posting stuff or having exchanges about what your dosage should be, it’s not going to get through,” Mr. Frankel says. “That’s part of that management thing, and you have to be on that. That’s what people don’t understand about branded community. Every other community is just hands free, let the servers take care of it. Totally different thing here. The difference is, as soon as you put out a branded community, all of a sudden the pharma companies get what they never had before, and that is a human heart. People start to see, wow, they’re not just pushing drugs on us, they really do care about people, and that’s why they’re putting people in touch with other people.”

The ultimate goal of a branded community is getting people investing their own human interest, their non-rational interest, their loyalties into the brand because the brand is supporting things that matter to them.

“Think about what would happen if you have patients with a chronic condition, who over those four or five years are now invested through the auspices of the pharma company with its branded product,” Mr. Frankel says. “What happens when all of a sudden the patent expires and generics start becoming available? You see a huge drop off. But not if they’ve invested time, effort, money, and their loyalties into the brand.”

TGaS Advisors, a benchmarking and advisory services firm serving the pharmaceutical industry, brought together digital marketing executives at GlaxoSmithKline, Novo Nordisk, Ortho-McNeil Janssen, Sanofi-Aventis, Shire, Takeda, and other companies to develop consensus on key aspects of FDA Guidelines on social media. Their conclusions, together with benchmark information gathered from 62 brands across 18 companies, are being presented at the DDMAC hearings today, Friday, Nov. 13, by Donna Wray, who heads the Internet and Relationship Marketing Practice at TGaS Advisors.

Ms. Wray will present the group’s consensus on adverse-event reporting in the morning session and on correcting user-generated content and regulatory requirements on language in the afternoon.

Suggestions on adverse-event reporting

Adverse-event reporting requires four distinct criteria: an identifiable patient, an identifiable reporter, a suspect drug or biological product, and an adverse experience or fatal outcome suspected to be due to the suspect drug or biological product.

According to TGaS Advisors pharma industry panel, adverse-event reporting is treated as very important by the industry, but the panel believes that adverse-event reporting across the entire Internet is impossible. Most people post anonymously for one thing, and contact information is rarely available. For another thing, the quantity of posts is simply too large to even attempt to track down details for all of them.

The TGaS Advisors panel believes that when pharmaceutical companies monitor online user-generated content, they learn a great deal. They learn about misconceptions to improve their communication and about potential problems and better methods. And this learning is good for the public health. The panel believes that FDA should acknowledge this and encourage more learning.

The panel’s suggestion to FDA at today’s hearing is that the agency should continue current adverse event reporting processes, plus encourage more use of Medwatch Online Reporting Form (3500). The agency should consider general publicity promoting the form (sponsored by the FDA or by a trade organization) and allow (but not require) pharma companies and their agents to post a single line with a link to refer to the location of the Medwatch information. For example, “To report a serious medical product problem, see the FDA’s Medwatch.”

Correcting user-generated content

When it comes to the issue of correcting of user-generated content on the Internet, the TGaS Advisors panel wants FDA to realize that content not provided by the brand is never up to regulatory standards, and even doctors don’t use “fair balance.” Within a brand, time for reviewing and correcting material is a minimum of four weeks, across pharma companies and brands. And most user-generated content has no mechanism for a “correction.”

A comment posted as a correction, meanwhile, may be placed far from the original misinformation. Wikis, which are collectively edited, are notorious for “edit wars.”

What the brand doesn’t own, it can’t ensure the quality of, the TGaS Advisors panel says. Correcting of most misinformation is not advisable and gives an air of authority to content that is not authoritative. To correct one piece may imply that the content will be monitored over time and “re-corrected.”

Meanwhile, correcting all misinformation is impossible. The number of Wikis alone numbers in the millions according to wikia.com. The average product name is mentioned in more than a half-million Web pages on the Internet today, using a Google search.

The TGaS Advisors panel recommends having an official mechanism to allow people to distinguish between content subject to FDA regulations and other content. An official “seal” would appear on brand site and with other content subject to FDA guidance. The “seals” would all link to a common page explaining 1) that FDA protects the public health through guidance for marketing, 2) what high standards marketing is held to, and 3) the important role of other sources, such as recognized medical experts

Another idea the panel has is to post way signs leading to official content. An average of 10% of brand site visitors come from Wikipedia. Wikipedia, while largely useful, has a lot of content from non-experts, and the link to the brand site is near the bottom of each Wikipedia entry. The TGaS Advisors panel suggests encouraging prominent sites to post a link to official info and allow pharma companies and their agents to post a single line or link to refer to the location of the official site, as in “For information from the manufacturer, see the official Product site.”

Adhering to regulatory requirements

The TGaS Advisors panel is also offering some ideas on adhering to regulatory requirements. When it comes to ads with very limited space, such as some paid search ads, the panel recommends the ads be either reminder or unbranded advertising. When it comes to ads with somewhat limited space, such as banner advertising, they recommend 50% of important safety information appear in final frame. And when it comes to serial media, such as online video or audio content, claim and fair balance should appear in equal prominence and at close proximity.