Monday, May 24, 2010

ePharma Summit Recap

Thanks to all the presenters who braved "Snowmaggedon" to present at this year's ePharma Summit in Pennsylvania.

There were a lot of interesting presentations including some highlights from @skypen on his recent FDA interview with DDMAC's Dr. Jean-Ah Kang.

Of particular interest to me, since we are actively involved in developing guidelines and training, was the presentation from Mel Halkyard, who discussed the process she manages at Eli Lilly to implement social media guidelines and practices.

When talking about her learnings from the process, which is almost complete, Mel highlighted several themes:

  • 1. K.I.S.S. (Keep It Simple, Stupid). When talking about personnel guidelines, it is important that everyone understands what is needed and required.
  • 2. It's important to ensure that your social media guidelines are in sync with the rest of the personnel policies and procedures you already have in place.
  • 3. It s a good idea to assign ownership so that there is a clear decision tree, and decisions can be made when needed. Ideally, a single point of contact, possibly a Social Media Czar, or an Interdisciplinary Social Media Steering Committee. Also needed is the sponsorship of senior leadership; preferably from someone who also sees the value proposition.

It's important to bear in mind during this process that it is a living document. Because of the rapidly changing communications landscape and the tools that go along with it, new situations will develop which may require that your guidelines change.

When using social media in particular, it's necessary to distinguish between the blurry lines of personal and corporate communications and to make it clear for staff what is acceptable from the company's perspective. Once you have your guidelines in place, it is then necessary to educate staff on the most productive uses and implementation of social media.

Does your company offer social media training or do you have guidelines or policies in place?

Originally published on Full Spectrum Blog Feb 17th 2010

Crowdsourcing for a Cause

I just read an excellent article about crowdsourcing health care solutions by Eliot Van Buskirk atWired. The article, titled "Harvard-Based Crowdsource Project Seeks New Diabetes Answers," describes in great detail a new initiative to crowd source diabetes information with an end goal of curing Type I diabetes. (Almost 2.4 million people in the US suffer from Type I diabetes.) "Using federal stimulus funding from the National Institutes of Health, Harvard Catalyst has teamed up with InnoCentive to explore whether open innovation and crowd-sourcing can spark new directions, collaborations and research in the healthcare community."

Congratulations to the National Institutes of Health for funding this and to Harvard's medical research department for developing this crowdsourced medical initiative sure to help those with Type I diabetes.

What's particularly interesting about the first phase of this project is the goal of ideation. The project's initial objective is not to identify a specific cure, but to start with the basic premises that there are questions or criteria that may not have been considered before now.

The study is awarding prizes ranging from $2,500 to $10,000 to anyone from experts to informed people who contribute the best answers. Should this be successful, it will continue with a new model for preliminary medical ideation and join a fine list of sites like patientslikeme.com and curetogether.com that are crowd sourcing medical innovations. Every day, the benefits the collective holds becomes clearer in everything from medical ideation to proxy clinical trials. (For a sound discussion of the merits of crowd sourcing, please see the following "How the Netflix Prize Was Won," also by Eliot Van Buskirk)

As this NIH-funded Harvard project moves forward with a potential second phase in crowdsourcing diabetes Type I treatment results, how great would it be for the project to talk to some of the sites who are already active in this area on a more clinical basis?

Originally published on Full Spectrum Blog Feb 16 2010


The FDA Spends $72 million to Speed Up Detection of Monitored Product Problems

As reported by CQ Healthbeat News, the FDA has awarded a contract to speed up the detection of product hazards. In a nutshell, the FDA awards $72 million over five years to Harvard Pilgrim Health Care Inc to develop a scaled down version of the Sentinel System. The system meets the requirements of a 2007 law intended to strengthen FDA drug safety oversight.

Forget for a moment the Orwellian program name "the Sentinel System", it's great to see the FDA moving up the timeline in their desire to learn sooner about Adverse Events. However, I find it surprising that they stopped three quarters of the way and didn't go right to the source.

With all of the technology available to be on the bleeding edge of potential Adverse Events (AEs) being discussed by e-patients, the FDA has decided to spend $72 million on examining historical data. For the historians among you, my definition of historical is anything that is not a part of today's conversation.

Now I'm all for data analysis and recognize the importance of this analysis in predicting future trends and being able to highlight the potential for Adverse Events. I further recognize that it is likely the FDA will now be in a position to encounter Adverse Events slightly ahead of where they are now.

However, would it not be much more helpful for the FDA to be in a position to interact directly with the patient and with their explicit permission to learn about potential AEs maybe even before they are reported to HCPs or even submitted for Insurance reimbursement?

The FDA does such a great job relying on crowdsourcing for outreach and dissemination and even data visualization of their recall information. Why does the FDA not recognize the value this same crowd sourcing brings in post market surveillance?

Isn't it time that the FDA truly gets on the cutting edge of these Adverse Events and out in front of where patients go to doctors or file medical insurance claims.

Social Media allows us to conduct post-market surveillance in a real-time setting. We can spot potential problems at the initial mention where individuals are discussing product issues with friends and peers. Was the FDA not listening at its own most recent Part 15 hearing? There were a number of presenters talking about the tools that exists today to discover in real time, that's up to the nanosecond, people who might be experiencing an Adverse Event or just recently experienced one.

For pre and post-market surveillance the crowd of e-patients is ready to assist the FDA in their gargantuan task of protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, and products that give off radiation.

Do you know any Digital or Social Media monitoring vendors that would like to demonstrate the power of these tools in post market surveillance?



Orginally published on Full Spectrum Blog Jan 21 2010

Imagine the Power of a Proactive FDA

At the most recent Health2.0 conference in San Francisco we heard from Sanjay Koyani who is charged with web design and usability efforts at the FDA. Prior to joining the FDA Sanjay was in similar roles at both the HHS and the National Cancer Institute. The FDA has been making a lot of news recently for many things. Among the most recent newsworthy events involving the FDA, which monitors both food and drug safety issues was a peanut butter recall. Sanjay's team did a remarkable job with the dissemination of information to consumers and professionals around the peanut butter recall and the affected products.
Sanjay's team has become prolific users of Twitter and other social media tools to communicate directly with professionals and the general public. This has resulted in remarkable results both in terms of the speed with which information is disseminated and that at which the public is educated on an issue. Equally notable was the effort on the part of many citizens to aid in the dissemination of this information and to "pick up the torch' on behalf of the FDA in informing and educating citizens. Social media shows again how it can work at its best for another worthy goal.
I would like to commend Sanjay and the FDA in wholeheartedly embracing the power of Digital to accomplish their outreach and educational goals in a much more timely fashion that ultimately results in professionals and citizens who are more quickly informed and better educated. Sanjay was quick to point out that the direction of Aneesh Chopra has been instrumental in encouraging government agencies to do so.
At the same time as we head towards the FDA's DDMAC hearings this 12th of November I wonder if it is time for the FDA to do more and go the extra step for the benefit of the professionals, citizens and corporations that fall under its purview.
With the advent of digital technology and crowdsourcing it is now possible for the FDA to play a proactive role in the recognition of drug and food issues. Imagine a world where we the public could know at the same time as manufacturers - maybe even before - about issues with foods or drugs. Imagine an FDA that is better informed and able to deal with these issues as they are gestating. This is now a reality.
As the FDA begins to consider questions about pharmaceutical companies and how they will be allowed to engage in the digital space, I would like to suggest that the FDA seriously consider how it too could become a more proactive agency on behalf of all its constituents by becoming more involved in the cloud.
Building on their fine experience in distributing important information, the FDA could begin to actively engage in the dialogue and the collection of relevant data on a much larger scale. Reviewing crowd sourcing tools such as Flutrackr and Google's health, it is hard not to imagine a world where our Federal agencies could become proactive in managing and averting public dangers.
For years we have heard about "chatter" mostly from our intelligence and military organizations. Chatter could very well be used to make us more intelligent about matters of public health regarding both drug and food safety. Using the cloud to both anticipate and collect data on potential public dangers.
I can imagine the benefits of this more proactive, more informed FDA, can you?

Originally published on Full Spectrum Blog Nov 5 2009

Tuesday, May 18, 2010

The Art of Listening: The Importance of Social Media Monitoring

In order to effectively take advantage of the goldmine of information available online, you need to be plugged in and listening. In today's digital-driven world, companies and brands have to be sponges for the knowledge being dispersed through online and social media outlets in order to engage with key audiences.

The first step in any online or social media initiative is listening. Just as companies embark on market research before engaging in advertising campaigns, social media requires the same reconnaissance. While online initiatives can sometimes be more cost-effective marketing platforms, this does not automatically mean social media is an easier or simpler medium free of sound, strategic thinking. Social media is a two-way conversation and as any good conversationalist recognizes, listening to your counterparts is just as important as what you have to say.

Companies are already well-versed in monitoring traditional media outlets for mentions of their brand. An article in The Wall Street Journal or a mention on CNBC is closely monitored and catalogued. While print publications and broadcast outlets still carry significant credibility, so do the millions of individual brand ambassadors who discuss companies, brands, products and services through social media channels such as blogs, forums, Facebook, YouTube, Twitter, Foursquare, etc. The blog of a key opinion leader that is regularly read by the most influential people in your target audience is just as powerful as that mention in The Wall Street Journal. What are you doing to ensure that you have your finger on the pulse of the online community?

Through listening, a wide variety of things are capable – market research, crisis surveillance, tonality measurement, employee relations, etc. Listening prepares companies to better address their communications needs. As communications professionals, we may think we inherently understand our audiences and feel we might be able to skip listening as a first step and jump straight to the engagement level, where ROI is better analyzed. Those who do this, though, do so at their own peril, as they risk running ineffective campaigns which do not resonate with target audiences.
So how do we listen and what exactly are we listening for? Listening can be achieved through a variety of platforms – the simplest being through the use of Google Alerts and blog search engines like Technorati. More in-depth listening is also available with listening products. Before initiating your listening program it is important to determine what it is you are listening for? Are you interested in competitor intelligence on the other players in your industry? What does your audience think of your product or service? Are you looking for focus groups on your industries direction? These are a couple of the many uses for the social data available via existing communities.

With a system in place for listening, you can begin to monitor the online community for any mention of your brand, product, competitors and/or industry. Variables that are important to identify include praise, criticism, complaints, competition, potential crises, and influencer's. Armed with this knowledge and therefore a clear picture of your audience, you will be better positioned to run successful communications campaigns.

One of the most infamous examples of the value of listening is the “Motrin Moms” case study. In the fall of 2008, during the inaugural International Baby Wearing Week, Motrin unveiled an online ad on its Web site aimed at “baby wearing moms” that used the tagline “We feel your pain.” Launched on Friday, November 14 and read by a 20-something female, the ad said:
“Wearing your baby seems to be in fashion. I mean, in theory it’s a great idea. There’s the front baby carrier, sling, schwing, wrap, pouch. And who knows what else they’ve come up with. Wear your baby on your side, your front, go hands free. Supposedly, it’s a real bonding experience. They say that babies carried close to the body tend to cry less than others. But what about me? Do moms that wear their babies cry more than those who don’t. I sure do! These things put a ton of strain on your back, your neck, your shoulders. Did I mention your back? I mean, I’ll put up with the pain because it’s a good kind of pain; it’s for my kid. Plus, it totally makes me look like an official mom. And so if I look tired and crazy, people will understand why.”

Moms across the country were outraged at the suggestion that they carried their babies in a sling or wrap simply to be in fashion or that carrying their child was somehow a painful burden. Women were also offended by the characterization that moms are “tired” and “crazy.” On Saturday, within one day of the ad’s placement on Motrin.com, the snafu was the most tweeted about subject on Twitter, and by Sunday, there was a nine minute video uploaded to YouTube that displayed a collection of screen shots of the outraged Twitter posts interspersed with pictures of moms carrying babies. The large and vocal community of “mommy bloggers” called for boycotts of Motrin and before long, mainstream media was covering the story in full force.

The ad was eventually removed from Motrin’s Web site and Kathy Widmer, Vice President of Marketing for McNeil Consumer Healthcare, the maker of Motrin, sent an email to the angry moms who had bombarded Motrin with complaints to offer the company’s apologies.

The Motrin Moms case study easily erases any doubts about the importance of listening. It’s clear that neither McNeil nor its advertising agency were engaged with the target audience prior to the ad’s launch, otherwise both organizations would have better understood the vocal and vibrant community of women, and more specifically females, online. As social media guru Peter Shankman said at the time, “Mommy-Bloggers are not a voice to be messed with, probably because they’re one of the most clearly identifiable voices on the web.”

It’s also evident that in addition to failing to conduct any pre-campaign listening, when the ad launched and there were early rumblings of disapproval, McNeil was still not paying attention and therefore unequipped to alter the marketing strategy for Motrin. McNeil and its ad agency were wildly unprepared to launch this campaign. The New York Times reported that bloggers and Twitter users who were able to get the ad agency on the phone found that the agency “didn’t know a lot about Twitter and didn’t seem to have a clue that there was so much anger piling up online.”

The inability to understand and engage with your audience is the fastest way to sink any new communications platform. Spectrum partnered with Social Radar to demonstrate visually what this looked like for McNeil and their Motrin brand. As the following graph depicts, shortly after the ad’s unveiling, the number of online conversations related to Motrin skyrocketed.

Had McNeil or their agency been listening, it would have quickly been clear that something was afoot. Starting with the massive spike in discussions about Motrin starting the very afternoon the ad was launched. This would have been a first clue that something important was happening around the brand. For those that are in the school of “No such thing as bad publicity” it is interesting to note that in this case the Moms were so outraged they were calling for a boycott of the Motrin product and recommending competitor products such as Advil in its place.




Before the PR crisis, in the months leading up to the November 14 launch, Motrin enjoyed a relatively high positive rating with regard to sentiment (tone) in online conversations. The majority of customers were happy with the brand and product as can be seen in the following sentiment chart (below left). However, in the days that followed the ad’s launch, the sentiment turned extremely negative, as evidenced in the second chart (below right).



























If McNeil had been conducting its’ due diligence by regularly monitoring the online community, the company could have avoided having the anger of those displeased with the ad fester for days and the negative news coverage that followed. Even by reviewing a small sampling of Internet comments, executives at McNeil would have seen that the words being used alongside comments about Motrin were overwhelming negative – bad, problem, upset, hate, stupid, sad, dumb, hurt and annoying. As this chart illustrates, the sentiment trend was overwhelming negative.




McNeil’s lack of listening left the company in a less than desirable position. Motrin ultimately took too long to remove the ad from its’ Web site and what started as a campaign aimed at mothers, turned into one of social media’s biggest crashes.

While the Motrin Moms case study demonstrates some of the consequences of failing to monitor the online community, there are other examples of the power of listening that produced far more positive outcomes.

Spectrum was recently tasked with preparing the 2010 digital communications plan for RESOLVE: The National Infertility Association, a non-profit organization focused on helping men and women resolve their infertility issues.

Through a grant it received from the Department of Health and Human Services, RESOLVE was interested in promoting embryo donation as a viable family building option for those struggling to conceive. Spectrum sought to listen to the infertility community online – a massive network of women and couples communicating about their struggles through personal blogs, chat rooms, Twitter accounts, etc., in order to fully understand the issues these individuals face and how we might introduce them to embryo donation. By using Spectrum’s listening products, we learned several insights. The most surprising for everyone the client and the client team was that adoption is by far the runaway leader in family building methods discussed online and all other methods pale by comparison.





Resolve was caught off guard by this news and surprised to learn that adoption so drastically outweighed the other family building options. The client discovered that the space they thought they were operating in – where family building options like infertility treatment and in virtro fertilization were just as popular as adoption – was in fact, significantly different.
Removing adoption from the conversation, we were able to get a clearer picture of the family building conversation.





Keeping in mind this breakdown, we were able to tailor our digital plan to reach the pockets of this population who were struggling to conceive, but still yearned for a traditional pregnancy, making embryo donation a practical solution. Our upfront listening prepared us for what the space really looked like outside of any pre conceptions we may have had. As a result our campaign has been very successful.

Another example of the merits of listening demonstrates how the campaign you start can lead to spin-off campaigns in the social media sector. In October 2009, the Meatless Monday movement received a substantial amount of media attention with the announcement that Baltimore City Public Schools would go meatless in their cafeterias on Mondays and then-CNN host Lou Dobb’s aggressive response to this news on his nightly television program. As way of background, Meatless Monday, a campaign founded by Johns Hopkins’ Bloomberg School of Public Health, encourages Americans to go meatless one day per week to help reduce the risk of chronic preventable conditions like cancer, cardiovascular disease, diabetes and obesity, and also to reduce our carbon footprints and save resources like fresh water and fossil fuel that are required to transport meat. When listening to the Meatless Monday conversation, Spectrum quickly identified a large trend – when influential bloggers, Twitter users, etc. were touting the merits of Meatless Monday, they often did so by providing recipes for meatless dishes. As you can see from the below graph, almost a quarter of all Meatless Monday conversations include mentions of recipes.

While this was not the original goal of the campaign, the most influential online ambassadors in this space were using recipes as a hook to promote healthy and sustainable lifestyles. Out of Meatless Monday’s overarching campaign, grew a community of bloggers who found each other through recipe swapping. Knowing this, it would be in Meatless Monday’s best interest to include recipes in their marketing plan and promote healthy, meatless meals for Americans to prepare and consume on Mondays.

As a final example for this article, we did an analysis of the conversation for a client interested in the hysterectomy space. Prior to the listening project the clients marketing and messaging was based on the lack of scarring from the procedure. By simply reviewing the conversation cloud and the underlying conversation taking place around hysterectomies we discovered that what was really important was the pain involved and recovery time. So by refocusing the messaging around a painless process and speedy recovery the client was in a position to resonate quickly and in a more meaningful way with their community.




An old Turkish proverb says “"If speaking is silver, then listening is gold." Remember this as you prepare to engage in online and social media marketing and communications initiatives. Listening should always be the first step in any online campaign. To best understand your audiences and be effective in your outreach to them, you first have to listen to what they want.

Friday, May 14, 2010

Advancing Clinical Trial Recruitment: Social Media, Health 2.0 and the e-Patient

One of the biggest barriers in the development of new drugs and medical treatments continues to be the challenges associated with the recruitment of clinical study participants. Would you invest in a company that was late 90% of the time in its product delivery? This is the case in the clinical trial space today. In my opinion it is a broken industry that is almost always late and the overruns cost an average of $800,000 to $5,400,000 a day.

Is it any wonder the pharmaceutical industry as a whole is at its lowest point ever in terms of Shareholder ROI?
What can we do to improve the most critical piece of this industry the pipeline?

“About 2% of the United States population gets involved with clinical research trials each year. Among people who suffer from severe, chronic illnesses, only 6% participate. As a result, an increasing number of clinical trials are delayed because too few people...even knew they had the opportunity to get involved.”
Source: Getz, The Gift of Participation

“An overwhelming majority of people (77%), say that they would consider participating in an appropriate clinical study if asked. However, only 10% of those eligible to participate in clinical trials do so in the U.S.” Source: CISCRP, Harris Interactive

In a recent poll, 94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state that they have little to no knowledge about the clinical research enterprise and the participation process.
Source: CISCRP, CenterWatch

A 2007 survey determined that 91% of study volunteers interviewed would participate in a clinical trial again, and 85% said they would recommend a family member or friend volunteer in a study.
Source: CenterWatch

Well when you look at the research that has been done on this and there is a ton, some critical points jump clearly out. I have identified four of them above. What seems clear is that people just don’t know about clinical trials, what they are, how they can do them and where do they find them.

Combining the realistic challenges facing the drug development sector with the growing dialogue online about e-patients and the tools and networks now available to connect and inform the patients, we can combine our knowledge of the clinical trial process with our social media savvy in helping sponsors identify and connect with potential clinical study participants. The same technology platforms used to identify and help recruit participants could also be adapted to help sponsors select locations for the investigative sites or to engage with physicians -- potential new clinical investigators.

We know that patients are increasingly turning online for health information. We also know that patients are not informed about ongoing studies and so potential candidates are squandered due to lack of communication.

Insights and Approach

Social media tactics work very well alone or as part of a marketing mix. When combined with traditional methods the mix increases touch points and aids retention of study name and details. Digital tools scale well to an existing recruitment plan (involving traditional media outreach, advocacy relations, advertising, physician literature, etc.).

What can you do in the social media space for your trial?

• Digital audit of the space to determine the competitive landscape for other studies and community building efforts in the therapeutic category.
• Mapping audit of the disease category to indentify parameters and qualify the existing disease state conversations and potential trial candidates.
• Monitoring of signals and communications within the community so messages and responses can be tailored in real time. Reporting can be done regularly to inform results and the iterative process.
• Development of an awareness platform to mobilize the community and inform them about the specifics of the disease state and to pre-screen members on inclusion/exclusion; also for PI’s to direct potential participants for pre-screening
• Measurement and reporting, to quantify the existing space in terms of the size and engagement of the members. The initial benchmark serves to highlight the progress made in developing the community and funneling potential candidates. A final benchmark highlights the increase in recognition and awareness among the target population.

Clinical Trial Recruitment in Colon Cancer

We took the example here of colon cancer to show how this works. In the graph below you can see we were able to identify 33,487 people who are discussing colon cancer. This is a highly interested target population to let know about your trial. It includes potential candidates as well as motivated ambassadors who would like nothing better than to find a cure, and while waiting on that effective molecules to facilitate living with the disease. We can also tell where they are discussing this disease and know on what platforms we should message them.

In looking at the conversation cloud we can identify topics of interest to them. We can see that the conversation is about constipation and cleansing or healthy foods and better diets. Knowing what the colon cancer population is talking about helps us to talk to them. Who would run into a party and start shouting out topics of interest? This is why it’s important to take the time up front to listen to your audience, and learn from them.

When we look at the trending conversation we can see when topics of interest hit the community. For example in the case of colon cancer we know that on March 17th 2010, a spike was caused by the release of “the colonoscopy song” on March 17 2010 by Peter Yarrow of Peter, Paul and Mary fame. The video was released in partnership with CBS to deliver a serious message to viewers about the importance of colon screening. KevinMD.com gives a good write up on this here.

Colon Cancer Space

I. Breakdown by Media Type: This tells us where the conversation around colon cancer is currently taking place.

• Blogs, 66%
• Twitter (MicroMedia), 23%
• Mainstream Online News 2.6%
• Forums and Forum Replies, 5.3%
• Facebook, 1.5%
• Comments, 1%
• Videos, 0.5%
• Images, >0.1%

II. Conversation Cloud: This gives us a snapshot of the keywords in that conversation and possible messages.




















Topic Trending: This is a more in-depth look at some of the important topics in the conversation. There was one significant peak in conversation of the 33,489 posts.