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 shareable 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?”

Responses on the value of eDetails compared with in-person details differed significantly across the four practice areas covered – family medicine, oncology, cardiovascular and allergy/immunology – and suggest that biopharmaceutical companies have an opportunity to adjust the promotional mix for stronger returns.

Over the last two years, in-person visits to oncologists decreased by 14%, but eDetails for the group only increased by 4%. Allergy/Immunology docs saw a 5% decrease in rep visits, but eDetailing grew by 8%. Still, allergy/immunology docs only received 1.8 eDetails per week, on average, but would like to see 3.3 eDetails per week, according to the survey results.

In terms of perceived value, in-person reps ranked higher across the board. However, oncologists and family medicine practitioners said they were better educated by eDetails, whereas cardiologists and allergy/immunology docs said in-person reps provided a better education.

Regardless of whether a physician prefers eDetails or traditional sales calls, the kinds of material preferences included in a detail also vary by practice area. “If you go into a cardiology detail without referencing clinical trial data, they’re going to feel like something’s missing,” says Kevin Olson, CEO at Industry Standard Research, publisher of the survey. Oncologists, on the other hand, “don’t tell us the same thing” about clinical trial data, says Olson. Oncologists (39%) cited the ability to answer product-related questions as the most important aspect of a detail, followed by the inclusion of information that is “sufficiently patient focused,” at 30%. Fifty percent of cardiologists said clinical trial data is most important.

Samples remain a critical part of the in-person detail experience, according to survey results, despite the fact that many eDetailing platforms provide an easy way to request samples. Asked what is lost when in-person details go the way of the dodo bird, Olson says that distribution of samples was “one of the biggest results,” although it’s “pretty clear in our data that physicians do receive value” from the opportunity to dialogue with a human being. Asked about some of the more surprising results of the survey, Olson says one question asked about the importance of key opinion leader (KOL) content; he was surprised to learn that it did not rank highly in comparison to other aspects of the detail.

The 130-page report, titled eDetailing vs. In-person Detailing: A head-to-head comparison of Volume, Time, Value, and Outcomes, surveyed 118 practicing U.S. physicians during the fourth quarter of 2011. Participants completed a 15-minute web-based quantitative survey.

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.

Abram’s comments, made during a panel this morning at the Drug Information Association’s (DIA) annual meeting in Chicago, prompted audience members to probe Abrams, and his CBER colleague Lisa Stockbridge, branch chief of the Advertising and Promotional Labeling Branch, about specific policies governing online promotion. One audience member wondered whether unbranded, educational campaigns online could link to branded sites, or if that kind of activity would generate an enforcement letter. Abrams responded that his own question, in that instance, would be, “Why are you linking to a brand site?” if a campaign is designed specifically to educate about a disease, as opposed to a branded campaign designed to sell a product. When pressed, he said an educational or awareness campaign – which isn’t required to present risk information, since no drug is being promoted – linking to a brand site would “have to be considered on a case by case basis.” Industry has been browbeating DDMAC about issuing social media guidelines for years.

On FDA’s Bad Ad program, one audience member asked what sort of proof would be required to verify improper promotion by a sales rep, given that a discussion between a rep and a physician would likely be verbal and unrecorded. Abrams said that an extensive review of the complaint would happen before moving forward, and then a signed affidavit from the physician, testifying to what was said during a sales meeting, would most likely be required. John Kamp, executive director at the Coalition for Healthcare Communications, and moderator of the panel, wondered aloud about whether a sales rep making hundreds of calls a week would be able to recall exactly what was said during a specific detail. “Couldn’t a sales rep say, ‘I don’t remember what I said, but my training and common response in this situation would be X.’ Would that kind of [defense] fly?” asked Kamp. Abrams didn’t answer the question directly, but insisted that DDMAC was diligent in investigating complaints, and the circumstances surrounding a potentially illicit conversation.

Abrams also discussed a proposed update to Section 502(n) of the Federal Food Drug and Cosmetic Act (FDCA) dealing with “clear, conspicuous, and neutral” major statements, or legally-mandated statements on major risks associated with a given drug. The update was announced in March of last year, and deals with DTC advertising, specifically television and radio, said Abrams. One of the four proposals put forward by DDMAC would require that an “advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of a major statement.” Anyone who has seen a drug ad on television will recognize the target of this proposal; the last seconds of a DTC ad are typically used for a voiceover announcing a drug’s “major” risks, while simultaneously providing unrelated images associated with the actors or visual narrative of the commercial.

DDMAC is in the process of being elevated from a division to an office, a process that is “slow even by government standards,” joked Abrams. The new office will be separated into two divisions, healthcare professional and consumer, he said.

According to Contextweb, an advertising technology firm, marketers are remiss in assuming that consumers are only interested in clicking on a pharma banner when it’s on a medical or health site. By understanding what kinds of non-health sites – and categories of sites – that individuals visit (individuals that click on a pharma ad, that is), marketers can take advantage of cheap inventory served up in other content categories, like travel or sports, says Tanayia Washington, author of the report.

“We’re not advocating that [marketers] step away from health content, as a pharmaceutical advertiser. We’re advocating that you go beyond it…you can expand your buy,” says Washington. “The assumption is that if individuals are consuming a lot of this [non-health] content, they’re really interested in that content. If we can find them where their interest is, it’s a perfect fit for the advertiser.”

The report found that WebMD and Everyday Health reached 16.9% and 17.8%, respectively, of online consumers searching for information on a treatment for an ailment or condition, while the comparable reach figure for the long tail was 69.9%. Similar figures were seen with users who “bought a prescription for an ailment or condition.”

Washington said that placing pharma ads on a non-health site provided brand lift, although health sites offered the most brand lift.

Scaling up on the long tail is easily done, once a target group’s web behavior can be extrapolated, but safety is a big concern; advertisers don’t want their ads mixed up with inappropriate content. “As a pharma advertiser, you’re very concerned about safe environments, so you need to make sure that partners can provide that environment, and scale it, at the page level,” said Washington.

Of the 70 brands assessed in the report, well over half were classified as “challenged” or “feeble” with respect to online and mobile prowess. The lone “genius” of the group was Johnson & Johnson’s Concerta, which provides HCPs with access to Concerta’s formulary status with top insurers, customized patient education materials, and an ADHD diagnostic tool, among other things.

In contrast with L2’s online direct-to-consumer index released last year – which bestowed genius or gifted status on 19 of 51 brands – this year’s report found that just seven brands were above average, in terms of usefulness for physicians. After Concerta, Bristol-Myers Squibb/Otsuka’s Abilify had the highest digital IQ, followed by AstraZeneca’s Symbicort, Merck’s Januvia, AZ’s Seroquel XR, and Novo Nordisk’s Victoza and Novolog, in decending order. The rest of the 63 brands were rated average or worse. The most bipolar brand was Bayer’s Yaz, which earned a “gifted” IQ score of 131 for consumer efforts in last year’s report, but received a doltish IQ rating of nine for HCP efforts. Anything less than 70 is considered feeble by the report’s measure.

According to the methodology, functionality and content on a brand’s HCP-facing website accounted for 30% of the assessment, followed by digital marketing (i.e. off-site brand presence, visibility on search engines, and innovative presentation) at 30%, social media (presence on Sermo or Medscape) at 20%, and mobile usage (including app creation, mobile web compatibility, iPad integration, and utilization of Epocrates) at 20%.

Authors of the report wondered why most brands aren’t purchasing HCP-targeted search terms, investing in mobile, engaging in email marketing, or investing in display advertising. Only a fifth of the brands assessed provide online sampling. Additionally, 75% of the brands assessed did not advertise on highly-trafficked physician portal sites, despite four out of five doctors visiting those sites, and spending nearly half of their online time there, the report said. That’s compared to brand websites for HCPs, which reach 50% of physicians, but only keep them there for two percent of their online time. Just 28% of brand sites for HCPs offer e-detailing.

For brands that do advertise on physician portals like WebMD’s Medscape, nine of which use sponsored microsites within the Medscape network, marketers miss a key opportunity by not providing a link to the brand’s own HCP site, the report said. After all, physicians that use professional social networks write, on average, 24 more prescriptions per week than those who don’t, the report said, citing a Manhattan Research study from January 2009.

With respect to search engine marketing, Google and DTC sites are the largest traffic drivers to HCP sites. However, only half of the brands assessed returned professional site results – in paid or organic results – when searching for a drug by brand name. Eisai and J&J’s Aciphex was the only brand that returned paid professional ads when searching for both the drug name and the condition, according to the report. Other search standouts include AZ’s Symbicort, the only brand with a professional site ranked at the top of organic search results when searching by brand name. Novo’s Victoza was the only brand to purchasing professional and consumer ads against the phrase “type 2 diabetes mellitus.”

In the mobile realm, perhaps the most surprising data point was that 90% of the brands assessed had no brand-specific mobile presence whatsoever. Just seven brands have mobile sites, although companies have sponsored apps ranging from diagnostic and dosage tools to patient assessment and education. Unbranded HCP apps miss an opportunity to promote individual brands, the report said.

To download the full report, for free, click here. L2’s digital IQ index on DTC efforts from last year can be found here.

There’s no question, of course, that pharma is still being hesitant when it comes to actually engaging with social media, regardless of the desire to do so. Faceoff participant Bruce Grant, SVP, Strategic Services, Digitas Health, advises that it’s helpful “for us as marketers to think of social media not as a channel but as a conversation.” But, he adds “a conversation is not a natural instinct for a marketer, it’s learned behavior.” Currently, it seems pharma marketers main hesitancy stems from uncertainty of operating in a world where “marketers are no longer in sole control of the conversation.”

So will the FDA smooth the way with more guidance on social media? Jennifer A. Colapietro, Partner, Pharmaceutical and Life Sciences Advisory, Pricewaterhouse Coopers, doesn’t think so.  FDA hearings are only likely to result in guidelines and perameters and provisions, she says, “but the rubber really hits the road in your individual interpretations, and operationalizing those within your organization.”

So what can pharma do? One thing is to gain a proper understanding of what social media is. “There’s a common misconception that social media is just the triumvirate of Facebook, Twitter and YouTube. That’s not what social media is,” says Colapietro. “There needs to be some awareness and education about what it is, what the risks are and how you can use it.” Tune in here to find out more!

The first of this new Pharma Faceoff series is already generating some positive responses from industry. Steve Woodruff, President of Impactiviti, says on his blog: “Kudos to Pharm Exec for taking it on… let’s face it – video is where it’s at for on-line communications, and this is a great way to hash out some issues and gain needed exposure.”

Watch this space for more Faceoffs to come.

I was at the 2nd European DigiPharm conference in London last week. I didn’t manage the whole two days, but what I did see left me a little concerned that pharma is still struggling with digital marketing.

This is not a criticism of DigiPharm organizers. Intermitent Wifi woes notwithstanding, the  event was executed with surgical precision. It’s not a criticism of the presenters I saw, they delivered their messages with style and offered good solid advice. And it’s certainly not a criticism of the enthusiastic audience: DigiPharm was packed, row after row of eager marketing execs, laptops, iPads and smartphones at the ready, eagerly tweeting nuggets out to those less fortunate and unable to attend.

My concern centres on the obvious disconnect between the conference speakers, the people in the room and their bosses, or maybe their bosses’ bosses. Some of the questions and comments from the floor were from people genuinely nervous of breaking out of the digital marketing 101 mindset. My least favorite one-liner of the day was this: “If you’re not in digital marketing within five years you’ll not be in marketing.” It strikes me that this was true in other commercial sectors five years ago. So what, all the analog marketers moved to pharma?

There are great digital marketing initiatives and great digital marketing people out there in Pharmaland. But whether its lack of regulation, fast-moving technology, big-company bureaucracy, risk aversion, whatever, the excuses are running out.

I came away feeling sorry for attendees who got all fired up at this conference, only to go back to the digital desert of their home offices. My big takeaway from Digipham 2010? Never mind engaging with patients and HCPs, pharma CEOs need to start engaging with their own marketing people, listening to their strategies and their concerns, and give them the support they need to execute innovative digital campaigns and ongoing social media programs.

I’m not saying it will be easy, but for an industry that’s headline objective is to cure cancer, it shouldn’t be impossible.

Jacky Law

Sex and drugs and rock ‘n’ roll are infiltrating pharma. Jacky Law reflects on the benefits of the digital world.

Epiphany moments come when you least expect them. I had the taste of one recently when I heard a senior pharma sales manager on video describing his previous life as a rock journalist. The jolt came not so much from a ‘sex, drugs and rock ‘n’ roll’ experience infiltrating the industry, but that the career move should have seemed so effortless. Far from there being no apology for not having slaved it out as a sales rep for years, a whole new world was to be glimpsed in the simple confession that the transition had been perfectly natural: same work, just pharmaceuticals instead of drugs.

Suddenly, there was greater insight into the sheer scale of development in the e-world and why people who can prefix their job-title with an ‘e’ are so sought after right now.  I could see for the first time that just as one can never be too rich, too thin or too young, right now one can also never be too digital.

You don’t have to look far for reasons as someone has to take on the task of integrating this mounting wave of new collective and collaborative thinking into pharma’s famously conservative structures and processes. As a rule, the pharma mindset, at least at the marketing end of the business, has always believed that control of the message was not only possible but also desirable.

Digital, meanwhile, is more of a language. It can, and is, being used to try to control the message but new ways of working are being explored that use the medium’s connective and collaborative nature to maybe better effect. Knowing what to measure, how to measure, where to measure, are all up for grabs as teams become increasingly adept at integrating the powers of search and curiosity into the marketing mix.

A glimmer of the kinds of things that are possible came in an extension of the epiphany moment I described earlier when listening to Paul Wicks, R&D Director of PatientsLikeMe. Talking at the DigiPharm 2010 conference last week in London, Wicks described how patients, pharma’s real stakeholders, are gradually starting to demonstrate their power through sites like his and the changes they can produce in how their conditions are perceived and presented.

Sites like PatientsLikeMe, FaceBook, LinkedIn, YouTube, the ones that have become hugely popular because that is where everyone is, exert an influence and a power that is still being appreciated by e-illiterates like myself. My epiphany moments have been about a sense of the potential that is opening up as the practice of medicine evolves at a faster rate and in more dimensions than anyone – pharma, regulatory bodies, healthcare professionals, patients – previously realised. It really is very exciting.

Meanwhile, the PatientsLikeMe business — among others — presses on and produces, for example, its own validated real-time patient-reported research. The site is concentrating resources in a few communities — multiple sclerosis, HIV, fibromyalgia, organ transplants and epilepsy — and is actively seeking pharma companies to suggest how data in other disease areas might be used. Wick’s talk was called, ‘Maximizing data-driven partnerships between social media and pharma’, which means ‘Let us help you make sense of, and profit from, what patients are saying about their conditions, how they take their medicine, if they take their medicine, and a whole lot else that may become more important as the patient voice becomes louder still.

PatientsLikeMe is transformational because it makes it possible for patients to see new things as well as old things in new ways. They can see how they perform compared to other people with their condition, for example, or they can see what happens when patients like them take a ‘treatment holiday’. The most crucial thing, however, is that they have been given a real collective voice.

This voice, emanating from a digital way of interacting, could hardly be more different from the traditional pharma mindset and its engrained ‘control-the-message-at-all-costs’ instincts. But it is without doubt the voice of the future along with all those rock journalists and other geeks who not only get what is happening but are also in a position to help shape it.

Jacky Law

Social networking is no longer something people (patients, healthcare providers, physicians) are merely talking about, or something that’s part of our future. It’s something people are participating in today — right now — as you read this.

A recent report from ROI Research, Inc. — “S-Net (The Impact of Social Media)” — highlights the behavior of 3,000 social media users across 11 consumer categories, including healthcare/pharmaceutical, benchmarking how buyers use social networking websites to get advice on what to purchase, give advice on companies/products, and post content specific to various industries.

The information was collected via a 30-minute online survey from US respondents who access at least one social network regularly. The objective of the study was to determine how various segments of users participate with social networks in their daily lives, specifically with regard to the purchase process for different types of products and in relation to other media channels.

Of the 3,000 survey respondents, 1,888 made a healthcare/pharma purchase in the six months prior to taking the survey. Of those, 441 completed the healthcare pharma section of the survey. The following data, results, and percentages are based on those 441 participants.

Of those 441 participants, 12 percent of respondents follow at least one healthcare/pharma company on either Facebook or Twitter. 12 percent said they discuss pharma/healthcare on social networking sites less than once a month and only 5 percent said they discuss those issues once a week or more. Nearly half (47 percent) of respondents, when they do discuss pharma/healthcare issues, are seeking advice on what to purchase. Other popular reasons for pharma-related talk on social media sites include price comparison (34 percent), current products/releases (32 percent), giving advice (32 percent), and talking about sales or specials (31 percent). Surprisingly, connecting with customer service was the least popular reason for discussing pharma/healthcare online, with only 15 percent of those surveyed citing this as their reason.

Of those who responded to the pharma section of the survey, 33 percent said they are interested in receiving printable coupons from healthcare providers, pharma brands or retailers through social networking sites; 25 percent would like notification of sales or special deals; 23 percent would like information about contests or sweepstakes, and 21 percent would be interested in new product announcements.

However, 43 percent of respondents indicated that they would like to be contacted once a month or less, while only 4 percent would like to be contacted once a day.

Clearly, consumers want healthcare to be part of their online world — but on their own terms, in a manner and frequency they determine, and with participation remaining primarily consumer-driven.