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Pharmaceutical ExecutivePharmaceutical Executive-09-01-2009
Volume 0
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Big Pharma navigates a regulatory minefield to reach social media consumers. It's anything but 'business as usual.'

Big Pharma is slowly moving into the communications equivalent of the black hole: social media. While some companies are dabbling in blogs, others are posting videos to YouTube, and an intrepid few are writing text message–length posts on Twitter or Facebook. Will this scattershot approach add up to a coherent strategy that delivers measurable results from both a commercial and reputational point of view? Pharm Exec surveyed the field and found a range of modest programs that should eventually create big advantages for the companies that choose to engage in social media.

But to really "socialize" means having a two-way conversation—something that pharma has generally been wary of. After all, companies face a high-risk regulatory conundrum in responding to customer inquiries regarding adverse reactions, off-label usage, or even general conversations in the blogosphere. The challenge is finding ways to engage customers without crossing the FDA. "It doesn't have to be as scary as companies think, because there are a lot of ways to control the message," says Google's Healthcare Marketing Manager Neha Patel. "As long as [pharma companies] are controlling the information they put out, they can play in that arena."

So how can pharma make sense of it all? There are two schools of thought: throw everything against the wall and see what sticks, or wait and see what works and then create a "me too" version.

Sounds like business as usual in pharma.

Pfizer: Time to Change

The speed and scope of communication on today's Internet is truly amazing. For example, about a year ago, the keyboard player of a seminal folk-rock band The New Bohemians, was killed after he harassed a neighbor while taking Pfizer's smoking cessation drug Chantix—along with other, illegal drugs and alcohol, a mixture that is warned against on Chantix's label. The neighbor panicked and shot the keyboard player through the door.

Within days, dozens of posts began springing up on blogs and discussion forums about Chantix causing depression and suicidal behavior. Whether or not it was true, a few vocal citizens were changing public opinion. But Pfizer chose to not address the issues as they surfaced on the Internet, focusing instead on the traditional press. In fact until recently, pharma has seemed at a loss about how to interact with consumers who communicate in real time through online social networks. But finally, that's begun to change.

"We looked at social media a year ago and noticed that the conversation was happening with or without us," says Ray Kerins, vice president, worldwide communications at Pfizer. "I don't think there's a question any more as to whether or not we have to get involved in this space. We have no choice."

Kerins, who wasn't heading up Pfizer media relations during the Chantix crisis, says that the company is rolling out its social media in stages, and doesn't want to overstate its position. The first order of business is a new Twitter feed that's being used to push out corporate communications, including information about the pending Wyeth acquisition as well as its US discount drug program.

However, Pfizer remains cautious about jumping on board with a new technology that might not even be around in a few months. In recent years, industry buffs have seen a number of major social media players whither and/or die. Friendster gave way to MySpace, which paved the way for the current giant Facebook. But who knows if Facebook will be around in a year or if it will be crushed under the weight of the "Next Big Thing?"

"We need to be smart, and track technology as it goes. Instead of playing catch-up—which is where we are—it's important to figure out how we can be involved in a medium before it becomes a huge deal," Kerins says. "We want to have a real dialogue, and we want to do it in a way that is not us pushing, but listening and taking feedback and adjusting."

The problem is that right now there is no structured two-way dialogue between pharma and its consumers. In truth, there is no real social media being done in the pharmaceutical industry. Almost every initiative, from YouTube to Facebook, is being done with the commenting component either turned off or heavily moderated. In an era where all forms of communication are seen as tools for pushing pills, there is a built in bias against experimenting with new technologies that are not specifically regulated – there is a high level of risk in the simple unknown.

"One of the biggest challenges right now is changing the corporate mind set of Big Pharma," explains Ignite Health CEO Fabio Gratton. "Social media require a top-down shift in philosophy, as well as changes in the ground rules by which health and product information is disseminated. Individuals within these organizations are using new social media technologies with more frequency, but that doesn't mean the entire organization is ready to embrace these technologies and use them effectively.

"Companies like J&J, with its blog and Facebook ADHD program, are slowly opening up the channel and doing the right thing by taking small learnings and turning them into company wide insights. This allows other brands to see new possibilities and adopt those types of processes into their own marketing plan," Gratton says.

Start Slow, Build Big

Some experts feel Johnson & Johnson has a natural knack for patient dialogue because of its massive consumer division. In the past few years, the pharma giant has launched a handful of popular blogs, as well as YouTube and Facebook networks that seem to be catching on better than most pharma social media initiatives. Its head of communications thinks the answer lies in the support of senior management.

"We saw a growth in consumer-generated content, and we realized that we needed to get our heads around [social media]," explains Marc Monseau, director, corporate media relations at J&J.

SOCIAL MEDIA: Key Pathways to Success

But J&J also started with baby steps. Its first blog was the Kilmer House History blog, put together by Margaret Gurowitz, a communications employee who was fascinated with the company's history. "Part of the reason we are able to do what we do today is because she managed to work very closely with our colleagues in the regulatory and legal departments to understand what the concerns were," Monseau says.

As in most pharma companies, the major concerns of the J&J legal department were how to handle consumers making comments into an open-field text box, how to manage adverse event reports, and personal accounts concerning off-label use.

"[Gurowitz] constructed a policy and process by which to manage [those issues]," Monseau says. "That sent us down a road where we could experiment with all the blogs we have today, as well as our YouTube, Facebook, and Twitter sites."

In addition to legal concerns, there are still questions about how much value a pharmaceutical company can provide online. But at the end of the day, traditional advertising and marketing isn't going to draw a virtual crowd.

"The initiatives that seem to provide value are where we are providing content that isn't branded, but is moving us toward giving people content they can use," Monseau says.

For example, J&J has created a health network on YouTube to provide users with a bevy of unbranded health information. On Facebook, the company has created unbranded ADHD sites for adults to view information from experts, take self-assessment forms, and learn more about the disease.

"The degree of uncertainty and lack of clarity prevents the prescription-based industry from doing a lot of things that a consumer product organization could do," Monseau says. "It causes a lot of apprehension in terms of how to create a campaign."

Epic Fail

That apprehension came to a head in April when FDA sent 14 warning letters to various pharma companies citing inappropriate online text/link advertisements. According to the complaints, pharma companies could not include a brand name in the same ad with a disease state without including risk/benefit information. The problem is that it's next-to-impossible to include a risk statement in an ad that's just three lines long. The assumption was that as long as the link led to a page with the risk info, the pharma company was in the clear. But FDA made it clear that pharma can't assume anything when it comes to social media.

This was not an issue about social media, but actual marketing. However, if FDA is going to get testy over simple link ads, imagine how it will react to conversations about adverse reactions on Facebook.

When approached about participating in a social media forum, FDA declined to reply. Rather, the agency issued Pharm Exec a vague e-mail about how it monitors the Internet for improper promotions. This suggests that FDA may not be ready with a strategy to address overlaps within the regulatory space and create a pathway for oversight of social media initiatives by the prescription industry.

"Regarding whether specific proposed pieces comply with the regulations, we have a process in place that allows companies to submit their draft proposals for our advisory comments," FDA spokesperson Karen Mahoney states. "This allows them to receive our advisory opinion on the piece, and correct any regulatory issues with the piece before public dissemination."

Alexandra von Plato, chief creative officer at Digitas Health, suggests that FDA should tackle the uncertainty head-on by creating a public forum or developing guidelines for social media. By allowing the public to interact with pharma and FDA, the agency could help foster understanding of the kinds of information pharma should be providing in the social media space.

"Companies are experimenting with [social media], but it's like wading into unfamiliar waters," von Plato says. "You take a risk-averse, conservative industry and put them into a situation like that, and you're not going to get a lot of really meaningful conversations. The demand is there, but there is a barrier."

The question is: How can pharma engage in social media in a meaningful way that conforms to the regulatory confines set forth by the FDA?

"People need to have cooler heads," Kerins says. "Instead of complaining that FDA isn't giving [industry] guidance, there must be a level conversation. I've talked to the communications folks at FDA who say they are very interested in looking at this issue to create more certainty around what is legally appropriate and what is not. I can imagine that FDA is in a similar spot as us." In short, all parties stand to benefit from establishing some basic ground rules.

Google has had discussions with FDA to create pharma-specific ad formats that will satisfy the concerns about fair balance and ensuring that the public is not misled. "Search advertisements drive the bulk of traffic across different search engines to company Web sites so they are still incentivized to working with us," Patel says. "If you build a site and you don't drive traffic there, then it's just going to sit there, and no one is going to find it."

Listen to This

Rather than bury their heads in the sand or stick to only the safest forms of social media, a few companies are actually evolving their communications strategies to better employ these new tools. While everyone is playing the Facebook game, three pharma companies in particular are taking social media to the next level—and they're doing it through some pretty interesting methods.

While pharma might not be able to reach out to consumers directly, it can use the Web to listen to patient conversations in order to gain insight into how people are dealing with diagnoses, and identify the support they need. Companies can then enhance existing programs or build new solutions based on what they discover.

"We used to mostly talk about the drug, and now we help our clients talk about what people need to know about their diseases or how to find more information," von Plato says.

Digitas is trying to make its clients stop thinking of the Internet as a promotional tool to sell products and messages, and to start using it as an opportunity to engage patients and use the technology for customer service strategies. The company told Pharm Exec that it has created a tool that automates the information gathering process. In layman's terms, Digitas uses manpower to find out where particular groups are residing online, and then uses a series of algorithms to automatically feed pertinent data into its own database.

This might sound a little Orwellian, but Digitas insists it's a great way for pharma companies to sort through all the conversations and find information pertaining to adverse reactions, questions about treatment, or a particular disease state. "We've pulled out a good number of insights from these listening exercises, and the information filters back into RM programs and helps refine the language in email campaigns," says Sarah Larcker, senior manager of strategy analysis at Digitas. "For example, moms with children with asthma refer to inhalers as puffers. We want to talk to moms in their language, such that our messaging and the support we provide resonate with them."

Third Party Tweets

Novo Nordisk found an ingenious way to engage its audience on the social network site Twitter without having to rely on internal staff to constantly update the messages (or tweets). The company used its existing spokesperson, race car driver Charlie Kimball to send branded and unbranded messages about its diabetes drug Levemir (insulin detemir) along with his usual chattering about racing.

"Not having any guidance to work from, we just wanted to make sure we did it in a way that was acceptable to the FDA," explains Ambre Morley, associate director of product communications at Novo Nordisk.

Kimball was trained to never blend tweet with the brand name and the disease state, and all posts include a link to the brief summary. "Even though it's a stand-alone brand name in the tweet, we have to be compliant because it's associated with a page about diabetes," Morley says. "When Charlie tweets about a branded drug, it's because he just took his treatment—not because we are directing him to mention the brands."

Morley says she would love to be able to design the user page to track statistics and gauge return on investment. But Kimball's Twitter is a one-way communication; followers can't respond to his posts or send any sort of information back to Novo Nordisk. Morley explains that this is not because of regulations, but more because Kimball is a celebrity and just can't respond back to all his fans.

The biggest hurdle, according to Morely, was getting approval from Novo Nordisk's legal division to launch the site. "I asked everybody, 'Do you see any flaws or gaps in the program?' We definitely tried to do it right. Is it perfect? No. But as time passes, there will be more guidance from FDA."

Building a Better Forum

Of all the recent moves into social media, biopharmaceutical firm UCB appears to have found the perfect balance between social interaction and pharmaceutical engagement by hiring social network architect PatientsLikeMe to reach out to epilepsy patients. Rather than creating a marketing tool that drives consumers to a drug through health information or branded marketing, UCB is going to use this Web 2.0 tool to gather data about epileptics, including whether or not they are currently on a UCB treatment.

"Drug companies get longitudinal outcomes data as well as achievements and intervention," says Benjamin Heywood, co-founder and CEO of PatientsLikeMe. "UCB wants to explore the comparative effectiveness of all the different therapeutics and interventions on the quality of life of epilepsy patients."

Think of it as a large-scale clinical study with thousands and thousands of patients. Similar to Facebook, patients in this online community will have health-centered profiles; users will answer a series of questions to measure where they are at with their illness. "In the case of epilepsy, the program will help patients understand their experiences with seizures as well as the different interventions they are trying," Heywood says.

At a time when pharma seems scared to have patients post adverse events on a public forum, this begs the question: How can UCB get around the regulatory restraints and respond to patients through social media? "We're taking it head-on," says Heywood, "By having a pharmacovigilance person in the community." In this way the company can gather much more data on adverse events and different dosages.

Heywood makes it clear that this is not a UCB community. Day-to-day control will be monitored and handled entirely by PatientsLikeMe, and that company promises a non-intrusive moderation model to encourage the community to comment freely. Transparency will also play a big part on the site. PatientsLikeMe fully discloses exactly what it does with its data, who its sponsors are, and how it turns a profit.

How Soon is Now?

All that aside, the truth is that these new marketing tools represent less than two percent of the total marketing budgets of most pharma companies. But how long will it be until a generation weaned on the Internet displaces the Baby Boomers as the key drug purchasing market? Two, maybe three decades?

"Pharma is correctly being conservative right now because social media channels are the water that people under 30 are swimming in; but people under 30 aren't your prime drug market right now," says Melanie Oates, director of undergraduate business programs for the University of the Sciences in Philadelphia. "People my age are using Facebook, but they're just now getting their fingers into it. E-mail, however is in late majority and everyone is doing search. Pharma has to decide where it should properly spend its money."

Oates compares the current trends in pharma marketing with Lilly's health education outreach for Prozac in the late 1980s. At first, consumers were fearful of treating depression with drugs. But through smart conversations, Lilly was able to change minds about the positive aspects of the treatment.

"This is where social media can be useful," Oates says. "You can put something on YouTube to raise public awareness and the kids might see it and the adults might not, but someone in the media will see it, and then it becomes buzz and gets on the nightly news—that's when grandma sees it. After that, it becomes conventional wisdom because its multigenerational."

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