Sunday, January 31, 2010

Philanthropy, New Media, and Tragedy in Haiti: A New Era Brings New Ways to Help

I wrote the below a few weeks ago, and am just getting around to posting it here. An earlier version is posted here. Many others are focusing on the impact of new media - here and here are two great blogs to watch on this topic.

Philanthropy, New Media, and Tragedy in Haiti: A New Era Brings New Ways to Help

It will take years to fully recover from the 7.0 magnitude earthquake that hit Haiti on January 12. Along the way, a tremendous amount of resources will be required to help heal the injured, rebuild infrastructure, and provide general relief and services. As with many natural disasters before, both large- and small-scale organizations are already on the ground, trying to create order in chaos and help restore impacted areas to functional.

What makes the response to this tragic event different is the immediate utilization of new media to help organize efforts and, perhaps even more importantly, raise funds to support the work that needs to be done. Asking for help is inevitable when tragedy strikes; new tools, however, are making it is even easier to participate.

Perhaps nothing has had as immediate an impact over the last few days as mobile text messaging. This has been a critical element of sharing information and raising funds. The use of text messaging has been employed with great success – millions have been donated to aid organizations at a pace never seen before.

This type of effort has been in existence for several years, with organizations like establishing the process for a wide array of charities to receive donations via text messaging. This disaster, however, is a turning point for text donation opportunities, and with more than 280 million Americans possessing a mobile phone, we should anticipate that this avenue for supporting a specific cause will grow exponentially in the coming year. Chances are that this will become a de facto element of future fund raising efforts.

Twitter, the popular microblogging service, has also been a tremendous source of information regarding the earthquake aftereffects. Search for the hashtag #haiti and you will find yourself in a sea of tweets from individuals organizations. The information ranges from first person accounts (including pictures), detail on relief efforts, donation details, news, reactions, and conversations on how to help.

As evidence of how mainstream media has embraced this tool, one needs to look no further than NBC News Correspondent Ann Curry (@AnnCurry). An avid user of Twitter, she actively solicited local individuals for interviews.

The above is a brief but powerful display of how technology has influenced our immediate response to world events. It also highlights the importance of these tools as a means of gathering information and a growing expectation that we should be able to find real time updates for world events as they unfold. Long after #haiti stops being a top trending topic (i.e., one of the most referenced subjects), the tag will still be a viable way to see what people are talking about, providing a rich data source for insight on ongoing developments.

Creativity combined with new media has accomplished the feat of shortening the distance between a private citizen’s desire to help and the ability to do so by leveraging familiar tools and creating mechanisms to instantly connect and support. What will be tested in the coming months is the ability to keep individuals engaged and connected to the ongoing needs of a damaged country.

There is a danger that the immediacy of text donations provides people with a sense of “I’ve done my part, and I can move on” when in reality the harder part is the long term rebuilding efforts. In an information-soaked world, organizations will have to embrace the tools of new media (and the spirit of transparency and accountability) to maintain the attention of potential supporters, reminding them of why they acted in the first place, specifics of how their participation has made an impact, and how their continued support will influence positive change.

Wednesday, January 13, 2010

Social Media and the FDA

This is a long post. The bottom line? New policy should reflect and respect the medium.

“Global, social, ubiquitous, and cheap”

With these words, Clay Shirky, a prominent voice in on the social and economic effects of Internet technologies, succinctly encapsulates the appeal of social media. Within the past five years, there has been an explosive growth in tools that allow the Internet to act as a means for anyone, anywhere, anytime, to communicate with others. The capability to engage in two-way interaction is a significant shift from traditional information and communication delivery via the Internet, and this shift is raising questions in a variety of sectors.

Health information seeking and the web have long been intertwined. Health is one of the most frequently searched topics on search engines such as Google, with the number of searches growing exponentially each year. A recent study indicated that nearly two out of three US adults look for health information online, and 41% of e-patients (health consumers who use the Internet to gather information on a medical condition) have read someone else’s commentary or experience via social media channels.

With such a captive and engaged audience, why haven’t pharmaceutical companies jumped into the fray? Based on sentiments expressed at recent FDA hearings on the use of the Internet and social media tools, the answer can be boiled down to a simple notion: uncertainty. Uncertainty regarding whether or not manufacturers would be held responsible for content created by a consumer. Uncertainty of expectations and responsibilities when dealing with social media tools that are highly constrained by space limitations (Twitter, for example, which limits content to 140 characters per entry). Uncertainty of what types of sponsored links are appropriate, and fear that the FDA will respond to these efforts with warning letters, as they did in April 2009, leading to a marked decrease in such ads being placed.

As a result, what exists today is irregular and disjointed at best. As there are currently no guidelines to clarify a single approach, companies are left to their own best judgment, which may or may not be in the consumer’s best interest. This can also create unanticipated repercussions, as witnessed by the series of warning letters mentioned above.

The last time the FDA issued any guidance on how the Internet could be used as a mechanism for advertising and communication was in 1997. At that time, the agency contended its current regulations were sufficient, arguing that print media was similar enough to online media that no new guidance was required. This position immediately generated controversy. Given the tremendous development in technology and the advent of social media – much of which has made it abundantly clear that the online world is quite different than traditional media – both consumer advocates and the pharmaceutical industry felt the issuance of new guidelines was long overdue.

It is with this as a backdrop that the FDA released a notice of a public hearing and request for comments on this topic. This meeting took place on November 12-13, 2009, with public commentary still open and written comments being accepted until February 28, 2010.

The organizing efforts of interested parties leading up to this event were a valuable illustration into how social media has taken hold. Initially, bloggers with particular interest in the pharmaceutical industry reported on the hearing, providing their thoughts on what to expect. Soon, the conversation was broadened using Twitter, with the hash tag of #fdasm. This brought in a much wider audience, allowing for anyone using this to follow along the conversation in real time.

As the date grew closer and details for the hearing itself were being released (speakers, presentations, logistics for the meeting), one individual created a website devoted to this topic and invite others to contribute. The page, which still exists, contains an in depth array of documents and press coverage related to the hearing itself, a constantly updated Twitter feed for any tweets with the hash tag of #fdasm, and lists supporters of the site (which anyone can join). This is a robust example of how social media can be harnessed to create a collaborative environment creating transparency and the opportunity for participation.

Over the course of two days, more than sixty testimonies ranging from marketing and communications agencies, research companies, health and medical Web sites, major search players, pharmaceutical companies, and consumer groups, were heard to explain the current use of social media for health related purposes, as well as thoughts on how to guide policy and regulation. Conversation focused largely on advertising limitations, accountability for communications, how to incorporate detailed drug information into restricted space allowances, and adverse event reporting.

Given limited individual consumer involvement at the hearings, it is unclear whether the topics discussed reflect the full spectrum of opinions and insight. While public comment is still open for individuals or organizations to submit their thoughts, it would be prudent for the FDA to arrange a second hearing with consumer representatives to ensure that this is not overlooked.

In considering what policy might be warranted, different perspectives must be accounted for. From the pharmaceutical perspective, there is concern over what regulations may be placed upon the ability to advertise directly to consumers, a subject that was discussed at length by the speakers.

From the patient perspective, however, the primary interest is less focused on advertising, and more on being able to get the information they need at the time it is needed. At its core, social media policy within the FDA needs to take into consideration what is at the heart of social media – the consumer. It is consumer driven, participatory, and two way.

Policy should reflect and respect the medium.

Given this, a key question being posed is whether pharmaceutical content can be interpreted as information or advertising. The former would fit into the social media world, while the latter could be considered Direct to Consumer (DTC) advertising. In creating policy guidelines to help clarify communication and responsibilities of pharmaceutical companies, the FDA needs to take into consideration the differences between traditional media and social media. By creating guidelines that reflect the realities of social media, the FDA can balance their core mission of protecting and promoting the public’s health while providing guidance to industry groups.

This fundamental difference between traditional regulated media content and newer forms of communication facilitated by online mechanisms is new territory for the FDA, but territory they will certainly need to address as policy is determined. Perhaps the most striking difference in the social media/traditional media juxtaposition is that traditional media can be classified as “push” while social media is more “pull.” In the former, there is control over the message, while in the latter communication is open to anyone. In the former, a message is carefully crafted, signed off by internal parties, approved by a number of individuals tasked with the responsibility of owning the content. In the online world of social media, many consumers are more interested in immediate access to information, delivered in a way they can understand, using tools that are convenient, regardless of what time of day they go searching for it.

Social media involves listening to what others are saying, and observing how a product or idea is being discussed. Content is user driven, and thus less centralized. FDA policy needs to reflect this new world of communication.

People are increasingly sharing their personal experience and information online. In doing this, individuals are empowered to take more responsibility in managing their own health. However, most consumers do not check sources to see whether this information is accurate. This is not to say that what is posted is false or misleading – it is entirely possible that someone could have a more effective treatment, or very real side effect, that simply has not been studied in a more formal setting. With all of this in mind, however, there is a clear space for pharmaceutical companies to take initiative and provide a substantial amount of expertise on drugs that they produce, and the health conditions for which they are approved. The question it poses is where this insight should be made available.

Of course, one of the complexities of social media is that there is no “one size fits all” approach. How various social media elements are utilized (videos, texting services such as Twitter, social networking sites, wikis, blogs, etc.) is highly dependent on the specific focus, strategy, and company culture. By participating in environments established by others, pharmaceutical representatives would help lend credibility to their mission in that they would show willingness to engage outside of environments they have created and that they control. For some topics and conditions, however, it may make more sense, however, to create space that is independent of an already established platform such as Facebook or

The notion of two (or more) way communications providing a more personalized experience cannot be understated when considering social media. While drug companies cannot be everywhere at all times, they can proactively create and participate in channels where an individual can share their ideas and first hand experience. This could be accomplished via the creation of monitored discussion boards, regularly scheduled webcasts, and partnerships with highly engaged e-patients when internal social media policies are being considered and/or updated.

FDA regulations need not dictate specifics of what types of tools may be used, or how any given online environment should appear; they do, however, need to provide consumers and companies with the confidence that they engage without fear of retribution. This type of regulation could be as simple as requiring transparency when a company representative elects to participate (i.e., not posing as a patient simply to promote one drug over another), and the expectation that discussion might ensue.

Given the unchartered territory encompassed by social media, FDA regulations will also need to address how companies can directly engage a consumer. This could include whether or not an industry representative, or a profile that is managed by multiple people but represents a single company, is permitted to engage in ongoing discussion, or whether they simply provide factual information and then remain silent. With initial guidance from the FDA, companies and consumers could then move to determine what their specific approach will be, knowing that the baseline rules have been set forth.

One element not raised within the November hearings but noteworthy from the consumer perspective is that current marketing rules mostly address what happens before someone takes a drug. The FDA must to also address what happens while someone is taking the drug. Within the FDA, the Division of Drug Marketing, Advertising, and Communications (DDMAC) holds responsibility for ensuring prescription drug information is “truthful, balanced and accurately communicated." One of the reasons social media has taken such a strong hold within the health sector is that one consumer can hear directly from another to get answers to questions such as what side effects have been experienced, whether or not people are complying with recommended dosage, how else the drugs are being used, if cost is the most significant barrier, and whether any alternative approaches proven more effective.

This type of information, particularly for those with a chronic condition, is an ongoing conversation that is dynamic and contextual, which is the very need that social media can satisfy.

In relation to this, the FDA would be wise to consider sponsoring research to poll consumers on how they are using the Internet, including social media, with a specific focus on prescription drugs as they approach policy decisions. In this way, they can gain more up to date information regarding how today’s consumer is using social media. Are they looking for information only? Adherence information? Side effects? Support? As the speakers at the hearing were principally industry representatives, there is still an unanswered question with respect to what the average person really doing online. Others have approached this question, including the Pew Research Center’s Internet and American Life Project and the National Cancer Institute. Space remains, however, for the FDA to get more focused information to help drive policy recommendations.

The agency should also recognize that even after initial policy is created, there will be an ongoing need for internal expertise to ensure that current policy is being followed, while looking into the future to make certain that what policy does is exist is still relevant. A number of firms already operate in this space for the private sector, and the FDA should consider creating positions, perhaps a new office, internally to monitor changes in social media. Responsibilities would include representing agency interests and providing expert council on updating policy and regulation relating to new media as needed. This position could also act as a conduit to both share and receive updates on how social media is being employed by consumers, ensuring that minimum standards are met.

As the FDA considers the above options and others not raised at the hearing, they should set an example of how to engage via social media by establishing a mechanism for any interested parties to discuss the options being considered. In this way, the FDA would gain first hand knowledge of using social media to create standards. Social media is about empowering individuals by giving them a voice – this would be a good opportunity to show that the agency is serious about making changes and protecting the consumer.

Typically the FDA takes up to two years to publish new regulations. Given the complexity of this issue, this could easily be pushed out until 2012. However, given the rapidly changing environment and increasing number of e-patients, it would be wise to prioritize this topic and create an initial set of guidelines within the next 8-12 months. These guidelines could then be modified within the next 8-12 months based upon findings from FDA-sponsored research on this topic. To expedite this process, a clear timetable should be established, with deadlines set forth on revisions and ability for the public to provide input.

Throughout the hearing, the FDA panelists asked few questions, mostly listening to the information and ideas being put forth. They provided little indication of how they would proceed, or when any regulations or policy would be issued, if at all. It cannot be denied, however, that social media is going to continue to develop in the coming years, and the FDA needs to take steps towards ensuring that consumers are reasonably protected from harm, provided with pertinent safety information regarding drugs, and that this information is within easy reach. Keeping an equal pace with private sector development is a near impossibility, given the speed of academic inquiry and the need for constituency approval for policy changes. Still, there are guiding principles that can be used to generate thoughtful and germane solutions to the concerns at hand.

There is no doubt that the number of people who use the web for everyday health decision making will increase, particularly as more people connect via broadband or handheld wireless device. With this in mind, policy needs to take shape to ensure that consumers are able to find reliable information and contribute in ways that both empower and inform. To quote Mark Smith, the CEO of the California HealthCare Foundation, "If we don't get policy right, we won't realize promise of health IT.”