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  The Internet has empowered consumers through blogs and social networking Websites, forcing the pharmaceutical industry to face daunting regulatory hurdles to join the conversation.

by Steven Niles

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People are talking, and the pharmaceutical industry needs to get in on the conversation. Pharmaceutical marketing is no longer a matter of simply pushing a message down to physicians and consumers. The use of social and interactive technology has put the customer in control of the message. Online communities and blogs allow the public to discuss and debate health concerns and the medicines that treat them. The industry must stop hiding behind its fear of regulatory hurdles and begin thinking about how to get involved in the interactive space.

The filters through which a marketing message must pass have changed considerably in the past 30 years, according to Kevin King, VP, interactive solutions, Edelman, New York (edelman.com). In 1975 there were three networks, three wire services, and about 50 magazines and 100 top papers. In 1995, there were four networks in addition to about 100 cable channels and 50,000 Websites. Now, the media filter has the addition of hundreds of cable channels as well as millions of Websites, blogs and forums, file sharing, and e-messaging.

"Communicators and marketers are finding it harder to connect with their audiences at the same time as their audiences are finding it easier to connect with like-minded people," Mr. King said at the Healthcare Marketing & Communications Council’s (hmc-council.org) May Industry Forum.

According to Mr. King, online communities are providing an environment where word-of-mouth communication is thriving. Internet users are online looking for advice and recommendations, making like-minded individuals the key influencers. As a result, a mass audience has been replaced by a small but relevant audience as the key to marketing success.

Mr. King believes that the key trends shaping internal and external health-care communications include: wikis, blogs, Technorati, search engines, message boards/forums/online communities, podcasts, and RSS feeds.

A major hurdle for pharmaceutical companies when approaching new, interactive media is to get past the push-marketing philosophy. With blogs, podcasts, and other interactive media, the users have much more control in when and where they receive the message. In some cases, they may even be involved in shaping the message.

People now have the ability to create, disseminate, and subscribe to content with ease. Although pharmaceutical companies are very interested in exploring the possibilities of a more interactive relationship with consumers, a great deal of apprehension exists around regulatory issues, according to Fabio Gratton, chief innovation officer, Ignite Health (ignitehealth.com).

Companies need to create policies and committees within their companies to develop solutions. The regulatory issues can be daunting, but Mr. Gratton believes that companies can find a way to participate in the interactive space in a regulatory-friendly way.

Although FDA has not developed regulations or guidelines specific to interactive technology, the same rules regarding mislabeling and misbranding that affect traditional forms of professional and DTC communication can be assumed to apply, according to Diane J. Romza-Kutz, managing partner, health and life sciences practice, Epstein Becker Green P.C. (ebglaw.com).

"To the extent a pharmaceutical, biotech, or device company chooses to get involved in these consumer discussions back and forth — whether they’re on the net or whether they’re on some talk show — they’re going to be bound by the regulations," Ms. Romza-Kutz says.

According to Ms. Romza-Kutz, in the past FDA has taken the position that there is nothing about the Internet or blogs that in any way allows a company to ignore the misbranding regulations.

Even though the agency has not created new rules, FDA recently demonstrated its understanding of the increasingly important role of electronic communication in health care with the release of a new guidance document in March 2006. This guidance is intended to describe FDA’s thinking regarding the format and methods of distribution of product information, including voluntary recall communications for FDA-regulated products or drug safety information. The agency now encourages the use of electronic communications for conveying all such important product safety information.

FDA has worked throughout the years with manufacturers and distributors to promote the use of electronic methods of communication and encourage the use of innovative technologies to disseminate safety information, particularly when doing so can provide a public health benefit. The agency acknowledges that electronic communications have a number of advantages compared with paper-based communications. E-mail and other electronic communications can be more efficient and more timely than regular or traditional mail. These types of communications also involve considerably less cost to the sender, and receipt or delivery can be automatically verified.

FDA has initiated several efforts to use electronic means to provide immediate and current agency updates to the public and to specific audiences. The agency provides Website updates on bioterrorism, new product approvals, labeling changes, product recalls, and medical product safety information. The agency also provides free e-mail subscription services for subscribers to receive updates on FDA-regulated products.

"FDA has embraced technology," says Will Reese, VP, strategy, Cadient (cadient.com). "The FDA Website is very accessible and adheres to the government accessibility standards. The FDA has video podcasts, which they started in the last few months on product-safety news. As well, they have four or five RSS feeds on safety news, drug updates, things of that nature. So, FDA as a whole is pretty familiar with the technology, and if you look at their warning letters, they have frequently included Websites as part of warning letters for other submittals. If there was something wrong with a print piece, they’ve also gone and checked the Web. They recognize that the marketing materials are out there."

FDA is unlikely to take a proactive stance in regulating the use of emerging technology by pharmaceutical marketers, according to Jonathan Lynn, partner, BusinessEdge Solutions (businessedge.com). The agency’s history suggests FDA will take a wait-and-watch approach to see what pharmaceutical companies do online.

"If the companies step over a perceived line, then FDA slaps the pharma company’s wrist and levy fines or citations," Mr. Lynn told Med Ad News. "But they tend not to be very directive in terms of saying this is what you can and cannot do via this channel or this medium."

Ms. Romza-Kutz cautions, however, that if FDA were to change its policy through a guidance document, the agency is not likely to become less restrictive. "If it is likely to change, it is only likely to change to become more restrictive, which is certainly not going to be a fun time," she says.

Mr. Gratton believes that FDA would applaud industry’s effort to get involved in online health-care discussions if the result was better, more complete, and more accurate information reaching the consumer.

"If there is an adverse event, wouldn’t it be beneficial to get that information recorded as soon as possible?" Mr. Gratton says. "Wouldn’t it create a better experience for the product? Couldn’t you catch things sooner? Couldn’t a Vioxx-like problem be avoided if, early on, when you’re hearing this information, you’re able to get in front of it?"

Using blogs and podcasts could be useful in a crisis situation to get word out quickly of a product recall or a concern, according to Jed S. Nitzberg, owner, Flashlight Marketing Communications (flashlightcomm.com). Blogs are a good way to monitor for problems and to alert people when those problems have been addressed.

Mr. Nitzberg warns that no company should attempt any kind of public outreach if the company’s internal products and systems are in need of work. "You cannot PR your problems away, and you can’t blog or podcast your problems away," he says. "Even if you’re out there with the latest and greatest and have interesting things to say, when people come to you as a customer and you don’t have a quality product or quality service, you’ve wasted their time and broken your value promise."

The use of emerging technologies should be restricted to situations in which there is a good strategic fit, according to Mr. Reese. "One of the things we’ve seen is that unless they have a good strategic foundation, they’re almost novelty for the sake of novelty," Mr. Reese says. "What we’ve tried to do is look at some of these technologies and filter them through audience needs and online behaviors ... Just adding some of these bells and whistles may not have a real brand impact at the end of the day."

Mr. Nitzberg says managers should remember that new technology always requires new resources to implement and a commitment to provide those resources for the long term. "If you start a blog, you have to keep it refreshed, you’ve got to keep it going," he says. "You start a podcast, you’ve got to keep it going. You don’t necessarily have to do it every day or every week, but you’ve got to be prepared to keep it going. It has to have value, it has to be easy to get to, easy to use, etc."

Given the ongoing nature of these emerging technologies, Mr. Reese recommends an internal advisory board be put in place within the pharmaceutical company to take ownership of the episodic nature of the channels. This board must determine factors including how to use the channels, what the content will be, what the tone will be, and what messages will be conveyed.

"These vehicles allow you to tell a story over time," Mr. Reese told Med Ad News. "It gives you the opportunity to educate people over time to build their level of education and not have to have a consumer or professional instantly, within a few minutes, understand everything."

An advisory board will help deliver a product with more credibility, according to Mr. Reese. Good use of emerging technology can translate into a relationship marketing program that can last months or years.

On the professional side, nontraditional media and cutting-edge technology extend the reach and frequency of traditional marketing, according to Joe DeBelle, senior director, marketing, Lathian (lathian.com). These new marketing techniques can help overcome the obstacles in the marketplace, such as sales representatives’ limited face-time with physicians and the decrease in live-meeting attendance.

"Some of the old tried-and-true methods are being minimized in terms of being able to get the message out," Mr. DeBelle says. "The cutting-edge technologies allow pharma marketers to pursue a new venue, and the smart pharma marketers will take advantage of that to try to beat their competition to get their message out."

Physicians are increasingly making use of the Internet in their practice. Manhattan Research analysts say 579,000 U.S. physicians report having high-speed Internet access at their home or office in 2006. In fact, 142,000 physicians report they are using the Internet during patient consultations. Manhattan Research analysts found that 610,000 U.S. physicians use search engines to find medical information online.

Despite a relatively stagnant market for electronic detailing, physicians still voice a strong demand for electronic interaction and online customer service with pharmaceutical companies, according to Manhattan Research (manhattanresearch.com). In fact, 481,000 physicians report they have used or are interested in using a customer-service portal from a pharmaceutical company.

Blogs

Some companies have already realized that sponsoring blogs dedicated to particular disease states is a good way to reach consumers. Amgen Inc., for example, promotes its own disease-education Website, chemotherapy.com, with a sponsored link on thecancerblog.com. Amgen (amgen.com) is the marketer of Neupogen SingleJect, indicated for the prevention of neutropenia associated with cancer chemotherapy.

Pheedo Inc. (pheedo.com) is one business offering a service that enables companies to buy ads across a blog or RSS feed network.

The next step, however, is for pharmaceutical companies to host or sponsor dedicated blogs directly. Mr. Gratton believes that a blog used to discuss the appropriate use of a product and answer questions would be no different than the 1-800 numbers for information that appear on all packaging. "This is just a different way to be able to collect information and have a healthy dialogue with the people who are using your product," he says.

To find the appropriate resources to put toward managing a blog, companies should extrapolate from their current structure, according to Patricia Pesanello, chief knowledge officer, BusinessEdge. The same areas of the business that address 1-800 calls could moderate and manage a company’s blog.

"If a call comes in, and it’s dialogue that happens to be conducted over the phone line, more often than not the group responsible for that call is somewhere in the medical area," Ms. Pesanello says. "If you extrapolate from current structure, a blog is more likely to be mediated heavily by the medical area."

The medical communications department is trained to take the calls and is prepared with certain template responses. If an adverse event is reported during the call, the call can appropriately and properly be recorded. The process could work similarly in a blog environment.

Establishing a dialogue between consumers and a company’s medical experts creates an opportunity for the industry to dispel some of the mistrust that has built up in the public’s perception.

"It’s much harder to distrust a person than it is to distrust a corporation," says Greg Page, Ph.D., FDA life-sciences practice leader for the national life-sciences and health-care regulatory practice of Deloitte (deloitte.com). "If you’ve got a physician or a medical director with credibility and credentials who answers these questions ... that translates back to the company."

Ignite is working with a client to help establish policies and guidelines for employees who access blogs after hours or on weekends. The company is trying to address what can and cannot be said by employees and how issues of full disclosure and transparency can be addressed.

"Every pharma company should be creating those policies right now, because people are talking about their products," Mr. Gratton says. "Until those policies are in place and approved by their legal and regulatory committees internally, I don’t think companies will ever turn to this space because they see it as too much of a risk."

For a pharmaceutical manufacturer, hosting a blog can present regulatory challenges, according to Mr. DeBelle. Pharmaceutical marketers have responsibility to provide fair balance in conjunction with any form of product information, which can be difficult in a free-flowing environment like a blog. The company would be responsible for anything posted on a company-sponsored blog, even items posted by visitors to the site from outside the company.

One of the first questions Ignite receives from its clients is in regard to FDA’s stance on consumer generated media, specifically blogs.

"The reality is, just like FDA has not issued any guidelines on Internet promotion overall, they have not issued any guidelines on consumer-generated media," Mr. Gratton told Med Ad News. "The tendency is that the same rules that apply to any promotion also apply to consumer-generated media."

There could be a case to be made that the regulations need to catch up with technology, according to Mr. Nitzberg. "But companies have been sponsoring Websites around social and quality of life issues and chat rooms for a few years now without problems, but again, they’re heavily regulated," he says.

Beyond regulatory concerns, pharmaceutical companies interested in opening a dialogue with consumers through a blog may be concerned about a lack of control over what visitors to the site can say. Mr. Nitzberg wonders if pharmaceutical executives are prepared for the give and take that goes on in the blogging world. A marketer used to pushing a message out in one direction may not be prepared to deal with the negative responses that could develop during a back-and-forth dialogue with customers.

"A lot of folks get used to one-way communication," Mr. Nitzberg says. "We’re used to saying, ‘Here’s something about our product. Take it in and be attracted to it, consumer.’ What do we do when these people are writing back and saying our product is terrible?"

On the other hand, Mr. Nitzberg notes that various blogger surveys have revealed that bloggers have more respect for companies that engage. "If there is a debate going on [about a blog], and a company participates by saying, ‘Here’s our position and here’s our data, so tell us what you think,’ and engages that give and take, supposedly they get kudos for that."

There are steps companies could take to vet comments, according to Robb Hecht, business brand blogger, Media 2.0 (prmachine.blogspot.com). A site moderator could enforce a set of guidelines for commenting. Such guidelines are not unusual, particularly in corporate blogs. According to Mr. Hecht, guidelines can prevent intellectual copyrights from being infringed upon by a comment from a consumer. The guidelines could state that all comments would have to be on topic, must be inoffensive, and may not promote any particular drug or product.

Strategem Healthcare Communications has been recommending the use of interactive technologies to its clients. Blogs are a way for a company to position itself as an expert in a category, according to Janet D. Vennari, account group director, Strategem (stratagem-hc.com).

"For a client that doesn’t have the lead market share in a category, it’s a way for them to position themselves as a leader and be able to portray themselves as luminaries in the field both to professionals and to consumers," Ms. Vennari says. About 15% to 20% of Strategem’s overall work is directed to the consumer, and 80% to 85% of its business is focused on the health-care professional.

Looking at nontraditional media can be an asset for smaller companies that do not have the big-pharma budgets. "Nontraditional is a supplement to the traditional media, and in that sense, it’s like a guerrilla tactic," Ms. Vennari told Med Ad News. "In so doing, they have an integrated campaign for far less money than they could otherwise. It’s like a whole other world opened up to some companies that can do more with less."

Despite the growing interest in interactive technology, the static Website is not dead, according to Mr. Hecht. "Especially in the health-care industry, because of the apprehension and the fear of doing something wrong, a lot of people that use the Internet for health-care information are sticking with Web 1.0 properties still," Mr. Hecht says.

Strategem is working to make sure its clients are getting their current Web pages to work as hard for the company as they can. "We want to make sure they’re capturing e-mails from people who are visiting the site, so if people want to opt-in, then they can capture their names and use those for promotional purposes," Ms. Vennari says. "We have to watch what the HIPAA requirements are around the kind of information they collect and then how they use it. But some opt-in for more information about these products and discount coupons or events in the area is basic."

Podcasts

The use of mobile devices, such as a PDA, smartphone with PDA, or a pen tablet, was reported by 333,000 U.S. physicians, according to Manhattan Research analysts. Slightly less than 40% report using an iPod or portable digital music player. These analysts found that 487,000 physicians can be classified as users of new media, such as streaming video, downloadable audio content, or blogs.

Lathian is a provider of online promotional and educational solutions for life-sciences companies. Lathian has long been producing videos for e-detailing and e-learning initiatives.

"During the last five-and-a-half years, e-detailing, which is one of our flagship products, has changed significantly," says Scott Burkette, senior director of content development, Lathian. "It used to be quick little advertorials, almost entirely promotional in nature. Nowadays, it’s very different. They’re much longer."

Lathian’s e-details have become much more educational. Lathian typically videotapes key opinion leaders or other prominent physicians for e-detail presentations. According to Mr. Burkette, offering that video in a broadcast format such as a podcast would be a natural extension.

There are three different kinds of podcasts: audio, enhanced audio — which ties images to certain time points in the audio — and video podcasts.

In a survey of psychiatrists, oncologists, nephrologists, neurologists, pediatricians, cardiologists, and general practitioners, Lathian found almost 60% of participants prefer e-details with streaming video and audio content, especially those featuring key opinion leaders. The survey found 87% of respondents consider key opinion leaders that appear in e-detail videos to be knowledgeable and credible, and 71% said that key opinion leaders add significant value to the e-detail experience.

"I did this survey to help us find out if we should continue exploring and evolving and pushing the limits of this area," Mr. Burkette told Med Ad News. "I came away thinking absolutely, we should devote even more time and money to developing our video production capabilities, and video podcasting is right there. All the statistics I’ve seen on the ubiquity of iPods are very compelling. Being a discretionary dollar type of item, physicians exceed the general population in iPod ownership."

Mr. Burkette has been battling the misconception in the marketplace that an iPod is required to participate in a podcast. Although an iPod makes the podcast portable, participation is not directly tied to the device. All that is needed is iTunes or similar free software that can run on a laptop or desktop computer.

Mr. Burkette considers podcasting to be a broadcast medium. To make podcasting effective, the content must be made available in serial form. To encourage a physician to subscribe to a podcast series, the sponsor company must provide value that will draw the physician back again and again.

"The way I like our clients to undertake this is to identify a handful of key opinion leaders, set up some panel discussions on relevant topics, and film them all in a marathon session to keep the costs and everybody’s time efficient," Mr. Burkette says. "Then we would release them over a serial schedule, even offering something like a TV Guide, where you can see what’s going to be released when. That will keep the broadcast fresh and make the whole concept of a subscription serial worthwhile and interesting."

Podcasting could be ideal for continuing medical education as well. Already physicians are participating in continuing medical education by using audio tapes.

"It is an older, archaic format, where they buy the cassette tapes, and they can listen to them in the car," Mr. Burkette says. "Then they go online to fill out a test afterward to get their credit. But podcasting can be a very effective way to distribute CME material. When we do online CME, we offer it as a podcast after the fact for people who could not make it to any of the live broadcasts."

Mr. Burkette believes that podcasting is a good fit for patient education as well. He notes that the iTunes music store and other outlets for podcasts receive massive traffic. Making available a relevant, consumer-facing podcast for patient education is very compelling for pharmaceutical marketers

"You could get many thousands of views very easily," Mr. Burkette says. "If one of our clients had a leading drug in a category and raising awareness of a certain disease state or therapeutic class or just general education would benefit them, it makes perfect sense for them to be the initiator of that education."

Ms. Vennari has recommended the use of podcasts to a client of Strategem offering a smoking cessation program. The program already uses the Internet and the telephone, and Ms. Vennari believes that offering an educational reinforcement or motivational podcast would be a natural fit.

"Podcasting is the absolute antithesis of mass marketing," Ms. Vennari says. "You’re getting down to an individual level, which is a fabulous thing. If you can go to a group of physicians in diabetes or cardiology and give them whatever the information might be, that’s about as direct as you can get. And it’s got to be cheaper than sending a sales rep out who gets 30 seconds with him anyway."

One of the great strengths of a podcast is its ability to be syndicated through popular Websites such as Google Video, Yahoo!, or iTunes, according to Mr. Gratton. By subscribing to a particular podcast, users can be automatically informed when a new installment is available.

"We’ve seen companies going into podcasting more than anything else — more than blogs, more than RSS — because at least they understand that it’s a communication that they can control and that can be subscribed to through something as popular as iTunes," Mr. Gratton says. "Several companies have started publishing their podcasts on iTunes."

For example, Eli Lilly and Co. (lilly.com) makes available on iTunes a podcast series on pancreatic cancer, featuring interviews with medical experts in the field. Lilly markets Gemzar, which is FDA approved as first-line treatment for patients with locally advanced or metastatic cancer of the pancreas. Novo Nordisk AS (novonordisk.com) offers a podcast series providing instructions on the proper use of the company’s Flexpen diabetes product.

Mr. Gratton’s own Incendia Health Studios has produced an animated series on HIV available as a podcast. Mr. Gratton is president and CEO of Incendia (incendiahealth.com), a media company focused on chronic disease education. The animated series, called "Live With It," follows fictional characters in a serial, reality-based story line designed to elevate the dialog about life with HIV.

Gilead Sciences Inc. (gilead.com), manufacturer of the HIV drug Truvada, was one of the site’s first sponsors. "Live With It" is available for viewing at livewithit.com and is also available as a podcast download for portable devices such as iPods and PlayStation portable. Two of the largest HIV-related Websites — The Body (thebody.com) and AEGIS (aegis.org) — have partnered with "Live With It" to distribute and promote the series. The animated serial drama extends the story line with blogs created for each character on MySpace.com.

"Creating original content is key, because if it’s original, then there’s nowhere else they can get it but this company," Mr. Gratton says. "Second of all, have a strategy that goes beyond one podcast … People are used to the concept of new, updated information, and if you’re not prepared to deliver on it, you’re going to be a one-hit wonder, and you’re demonstrating a lack of commitment to your cause."

Companies need to have a strategy in place for how content is going to be rolled out. "The rise of all this new technology forces people to start thinking about dialogues, not in terms of just one-way, one-time communication," Mr. Gratton says. "It has to be two-way, it has to be consistent, and it has to be ongoing. Then you start to demonstrate to people that you are committed to educating or supporting a specific disease or product."

Incendia is also developing the Website HepB.tv, which is designed to be the first online television network dedicated to fighting hepatitis B. HepB.tv will feature programming from around the world to educate viewers about the disease.

"We’ve aggregated all the educational videos on hepatitis in the world from every organization, and we’re re-disseminating them out through RSS, through podcasts, and making them available to people on a variety of channels," Mr. Gratton told Med Ad News. "The beauty of MySpace and Google Video is they’re starting to centralize information, and people can go to one or two spots and quickly and easily have access to a variety of educational support tools about their disease."

Mr. Reese agrees that having serialized content is vital for a successful podcast. In the absence of serial content, however, the use of audio and video can still provide the personal feeling a consumer or professional is looking for.

"Because we don’t have the serial, episodic content, we’re doing one really nice rich-media high technology piece, versus something that’s going to have to have an enduring content story," Mr. Reese told Med Ad News.

Cadient assisted with the design of several Websites incorporating this strategy, using technology and community-building elements within a pharmaceutical marketing program. The site adderallxr.com, for example, incorporates video and audio to deliver personal context within condition awareness. The site features a video of Ty Pennington, host of ABC’s Extreme Makeover: Home Edition, discussing his personal experience with attention-deficit hyperactivity disorder. Shire US Inc. (shire.com) markets Adderall XR for the treatment of attention-deficit hyperactivity disorder.

RSS feeds

RSS Web feeds provide Web content or summaries of Web content along with links to the full versions of the content. Web feeds allow information from a Website to be syndicated to other sites and allow frequent readers to track updates on the site using an aggregator.

An RSS aggregator will check for new content every hour, day, week, etc., depending on the settings. A pharmaceutical marketer with the desire to make an RSS feed available to the public would need to find a way to make a subscription to the feed compelling for the potential user. Thinking about this type of outreach requires a change of mind set.

"The word subscribe is important because e-detailing and traditional marketing efforts are tactical," Mr. Burkette says. "You create a piece, you get it in front of physicians, and you measure the impact on behavior and education. RSS feeds and podcasts imply regular broadcast. It doesn’t make sense to me to do a podcast or to do an RSS feed in which you’ve got two or three things to say total."

Mr. Burkette believes that some pharmaceutical companies do have a need to broadcast important information at frequent intervals. "There are important news flashes," he says. "A lot of our clients have many drugs in the pipeline, and physicians are interested in the progress of those drugs in terms of getting them approved and tested and making sure they’re safe and efficacious."

Mr. Gratton believes that RSS feeds have applications for the industry beyond just distributing news. In addition to as yet undiscovered opportunities, they could function as a means of channeling the most up-to-date product and label information from pharmaceutical companies to various health-information portals. "Companies still haven’t quite understood the power of things like RSS," Mr. Gratton says.

Online communities

Pharmaceutical companies are already sponsoring online communities around specific disease states. Lilly, for example, hosts adhd.com, which provides information, tools, and support for people affected by attention-deficit hyperactivity disorder. Lilly markets the attention-deficit hyperactivity disorder drug Strattera.

Cadient assisted with the design and strategy behind the Website hemophiliamoms.com, which uses peer-to-peer communication to deliver condition education and to bring personality to information delivery. The site promotes the hemophilia drug Helixate FS, which is marketed by ZLB Behring LLC (zlbbehring.com). On the site, mothers of children with hemophilia share their personal stories of dealing with the disease.

"We’ve tried to do a lot of programs that have people talking to people," Mr. Reese says. "It’s not technology or a brand talking to somebody. It’s a peer talking to them. We’ve been very successful in doing that."

According to Mr. Reese, Cadient’s clients recognize that virtual communities have an impact on people’s lives and change people’s ideas about therapy and the way they manage their therapy. "They want to see how they can catch up to some of the other industries with the emerging technology and figure out a way to leverage that appropriately for pharma in a way that is on label, within regulation, and has impact relative to the consumers," Mr. Reese says.

Online communities around particular disease states are now being generated within popular social networking sites, such as MySpace.com. This presents another opportunity for pharmaceutical manufacturers to become involved in an area where people are gathering.

"You’ve got to go where the people are," Mr. Burkette says. "And right now, podcasts, iTunes music store, and MySpace are definitely where the eyes are going."

According to Dr. Page, participation in online communities presents opportunities for the industry to present itself in a more human, more humane, and even a more charitable light.

Mr. Gratton agrees that pharmaceutical companies have an incredible opportunity in getting involved with online communities. He acknowledges, however, that the industry will likely be slow to do so. "This is still a slow-turning ship, as we all know," Mr. Gratton says. "They’re the last to adopt new technologies. They’re the most afraid of what could potentially happen and what the risks are. This is taking a long time for companies to be comfortable with the idea of participating in these dialogues."

Just watch

The simplest way to take advantage of the consumer empowerment trend is to simply monitor and gather information from these public forms of Internet communication, according to Jill Rogers, director, marketing research services, AllPoints Research (allpoints.biz). Companies do not need to participate in the conversations but merely monitor what people are talking about and watch for misinformation that is coming out about a product. The company can use the information gathered to construct a new perspective of the target audience.

"The company may also consider employing structured marketing research as a result of something they may have heard to validate whether the tidbit garnered from the Web has weight, positive or negative, which they can leverage or negate, as the case may be," Ms. Rogers says.

The industry needs to understand that even if the companies are not actively participating in blogs, people are blogging about them, according to Mr. Nitzberg.

"If nothing else, they have to be monitoring just as an early warning system to know what people are saying," Mr. Nitzberg told Med Ad News. "At minimum, what marketers need to be doing is monitoring these things, because people are going to talk about you. Get out there and use them for attitude research."

According to Ms. Vennari, blogs allow companies to hear directly from consumers that they might not hear from otherwise. These customers are tuned into the Internet and tend to be educated, have a higher income, and are involved in the therapeutic category. Depending on the disease state targeted by the product, this could be a key demographic.

Technorati (technorati.com), an Internet search engine for searching blogs, can be used to give a company an impression of the level of conversation around a particular subject or product.

"Technorati gives a sense of how much are people blogging about a particular term, and is this term hot right now?" Mr. Reese says. "Is there a lot of negative on the term? Is there a lot of grassroots around the term? It gives you a very good way to set up the strategy and recognize what issues you’re going to have to deal with in the online space that may or may not be as prominent in the offline space. Certain conditions have quite a bit of stigma with them. In the online space, people have a little more comfort with those conditions, so the conversations are a little bit different, a little bit richer."

The Nielsen BuzzMetrics service, marketed by BuzzMetrics Inc., is used by the top 15 pharmaceutical companies to measure consumer-generated media and word of mouth. A recent study conducted by Nielsen BuzzMetrics found that new drugs that generated even small amounts of pre-approval online discussion among consumers experienced a comparatively large and sustained increase in discussion among relevant communities once the drugs were approved for use among the general population.

"Brands that achieve preliminary buzz in relevant online communities tend to achieve greater momentum once the drug is approved," says Lydia Worthington, VP, client services, and health-care practice leader, Nielsen BuzzMetrics (nielsenbuzzmetrics.com). "While there are many factors that ultimately influence overall buzz and engagement, pharmaceutical marketers would be wise to consider investing in pre-launch initiatives that get patients talking and consequently primed for post-approval launch and marketing activities."

Ms. Worthington notes, however, that early buzz is not risk-free. "Even small amounts of negative buzz or consumer concern can travel quickly across the Internet, where they can influence the marketplace and regulators, in some cases leading to drug-approval delays and requests for more testing," Ms. Worthington says.

For this study, Nielsen BuzzMetrics collected, measured, and analyzed thousands of word-of-mouth discussions in online patient communities about four drugs. Discussions were monitored for six months before FDA approval and four months afterward. The drugs were Abraxane and Tarceva, both cancer-fighting drugs; Tysabri, for treating multiple sclerosis — which was voluntarily suspended from the market in October 2005 to undergo further study — and Byetta, a drug that controls blood sugar levels.

Abraxane, a breast-cancer drug with fewer side effects than existing products, captured less than 2% of online buzz for one month before approval and rose to only 4% of online discussion four months after approval. Abraxane is marketed by Abraxis Oncology (abraxisoncology.com).

By comparison, Tarceva, a second or third-tier lung cancer drug for patients in whom chemotherapy has not worked, captured sustained 2% discussion levels for six months leading up to approval and jumped to 16% levels of online awareness in the four months after approval. Tarceva is jointly marketed by Genentech Inc. (gene.com) and OSI Pharmaceuticals Inc. (osip.com).

Discussion about Byetta was less than 1% in the pre-approval phase and rose to 4% of all online discussion three months after approval. Byetta is marketed by Amylin Pharmaceuticals Inc. (amylin.com).

Discussion about Tysabri, a promising multiple-sclerosis drug, jumped from 4% six months before approval to almost 15% immediately before approval. The product was on its way to 20% discussion levels post-approval before being pulled from the market. Tysabri is jointly marketed by Elan Pharmaceuticals Inc. (elan.com) and Biogen Idec Inc. (biogenidec.com). In June, FDA approved the reintroduction of the drug.

Ms. Worthington notes that buzz about the Abraxane and Byetta was overshadowed by simultaneously occurring online discussions about competing products.

According to Mr. Gratton, hiring third-party companies like BuzzMetrics to aggregate data about product discussions provides a level of protection for the pharmaceutical company. "Typically the way companies are protecting themselves is, even though a third party will potentially see or hear mentions of off-label use and adverse events, those dialogues are not reported back to the pharmaceutical company," Mr. Gratton says.



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