Health Activists And Social MediaFDA Questions 1,2,3 and 5

Presented to the FDA’s Public Hearing “Promotion of Food and Drug Administration-Regulated

Medical Products Using the Internet and Social Media Tools”

November 12 and 13, 2009

This special Annotated & Expanded Version of the presentation includes additional data and commentary not presented at the hearings, and uses purple boxes like this one to share speaker notes.

WEGO Health Activists Are The New Opinion Leaders

Social Media Creators & Editors are

Health Activists

On average, they create content for an audience of 10,000+ every month*

Jakob Nielsen, Participation Inequality, 2006

*Source: WEGO Health Activist Benchmark Survey 2008/9

WEGO Health is a social network specifically for Health Activists – that 10% of social media power users who are most passionate about helping others with health issues and about using social media technology for health.

InfluenceWEGO Health

Activist

EllenAudience of

~50,000 people per

month

Featured blogger for Invisible Illness Week

Active member of Yahoo! Migraine Group

Featured in Headache Blog Carnival

Active member of care4dystonia.org

Active member of BioMedCentral

Active member of CafeMom

WEGO Health Activists Are Social Media Power Users

WEGO Health Activists are most often active several times per day, on multiple social media sites and communities.

“Companies are largely missing from the supportive, real-life conversations going on in health discussion groups, on social networks, and such…

I’ve been at this long enough to know they have regulations that get in the way, but everyone would benefit if (companies) could be at the table with us…”

--- Ellen, WEGO Health Activist

WEGO Health conducted a survey of over 160 Health Activists like Ellen, health social media leaders, to ask their opinions on the questions FDA addressed in these hearings. Their comments – like this one – will help bring to life our survey findings.

Health Activist Perspective – Survey Results SUMMARY

• Social media is an important tool for health communication, and Health Care Company participation provides value to the community

• But Health Care Companies have an obligation to the community to correct misinformation about their products, and to follow regulations

• Companies, web sites and the FDA should monitor adverse events, and provide simple means of reporting

• Regulation of Health Care Companies in social media is challenging, and the FDA should work to tailor regulations to the practical realities of social media

Source: WEGO Health Activist Social Media Survey, October 2009, 162 participants

Social media is an important tool for health communication

Each key point of our findings is explored and illustrated in the following slides.

How useful are each of these social media tools in helping people to understand important health issues?

Discussion Forums and Message Boards

Dedicated Health Social Networks

Social Media “Coverage of Health Events

Blogs Q & A Site General Social Networks

Health Activists clearly value social media tools, especially those that offer real opportunity for interaction, and dedicated health sites.

“It’s the people who seem to be the most interested in the topics and have done the most personal research and will tell personal stories…that’s what discussion forums are filled with… I think they’re wonderful, and you get such a variety of information…”

--- Bill, WEGO Health Activist

Strategic Implication: FDA and Health Care Companies must embrace social media to communicate effectively with consumers

Health Care Company participation provides value to the community

Health Activists told us that Health Care Company participation provides value to the community. These health social media thought leaders believe that companies do have valuable information, data, and expertise to bring to the table. Health Activists have a great deal of respect for expertise, because they themselves are experts.

Does the use of social media by Health Care Companies help people to understand important health issues?

brings accurate information into conversations about drugs or devices

provides important updates on products or services

addresses frequently asked questions about products or services

adds valuable professional expertise to the conversation

AGREE Health Care Companies’ use of social media tools…

A strong majority of Health Activists appreciate the expertise that companies could bring to social media conversations – they understand the context of company participation and expect full transparency.

How should Health Care Companies disclose their participation in social media sites?

And transparency, in the eyes of Health Activists, should be clear and visible. Most favored Company links, logos or other indicators – and felt third parties acting for the Company should be held to the same standards.

“I kind of see (company participation) as a little biased, but I do like it when you have a forum going on - and actual drug facts, what it’s used for, what the side effects are - when a company brings that into the picture, that’s excellent, either by providing links or listing everything right there…”

--- David, WEGO Health Activist

Strategic Implication: Health Care Companies should participate in social media - IF they bring valuable information

Health Care Companies have an obligation to correct misinformation about their products

While Health Activists do welcome industry involvement in their communities, they also feel that companies have obligations to be stewards of their products.

How should Health Care Companies get involved in monitoring and correcting misconceptions or misinformation about their products on other Web sites beyond their control? AGREE Health Care Companies…

Almost all agreed Companies should get involved when the information may be harmful to people using the product, or when the Company feels it has information helpful to the community. Health Activists do have high expectations – 63% agreed Companies should get involved in monitoring and correcting misinformation about their product anywhere on the Internet.

“The Allergan corporation jumped on our Dystonia forum, it was surprising, because we were talking about Botox and marketing, basically complaining about it, and they came onto the site and left a comment about it, and it was good.

It made it seem like we aren’t just yelling into the air, someone actually is paying attention to what we’re saying and our concerns, and listening. And it seemed like they couldn’t say much, but they said enough to say, ‘we are listening to what you are saying, and we care.’”

--- Jennifer, WEGO Health Activist

Strategic Implication: Health Activists welcome fully transparent corrections by companies – and trust companies who make the effort

Online content …can be altered from its original state by people who don’t work for the company

Agree Health Care Companies should be responsible for policing any unauthorized versions of their content

64%

Agree Health Care Companies cannot reasonably keep up with the monitoring of all mentions of their content

60%“Online content created by Health Care Companies, and regulated by the FDA, can be altered from its original state by people who don’t work for the company. This unauthorized, altered content can be posted or distributed. Indicate your perspective.”

While they favor Company policing, Health Activists acknowledge that monitoring the entire Internet is an impossible expectation.

“It’s paradoxical, really. It’s a good thing if (companies) could do it, but I can’t imagine how they could be everywhere. It’s sort of unreasonable.

I would tell them to hire people for that purpose. It’s important, it’s just important.”

--- Debra, WEGO Health Activist

Strategic Implication: Health Care Companies must monitor proactively, while FDA – and Health Activists – need to define “best effort”

Health Care Companies have an obligation to follow regulations

When do you feel a Health Care Company’s participation in Internet and social media technologies should be regulated?

When Health Care Companies…

Health Activists agree strongly that Companies should be regulated when they pay for or sponsor content. Comments, however, were seen as the domain of the consumer, and fewer Health Activists felt comments should be regulated.

“Health Care Companies have the most direct information about their own studies that they’ve conducted and their products, and we’ll lose that whole side of the conversation…

I think we need to balance that conversation with the negative perception of Health Care Companies . They should have their opportunity to present their side as well, we should have a real dialogue.”

--- Lauren, WEGO Health Activist

Strategic Implication: Health Activists want regulation – but not at the expense of Health Care Companies’ participation

Regulation of Health Care Companies in social media is challenging, and the FDA should work to tailor regulations to the practical realities of social media

What are appropriate ways for Health Care Companies to fulfill regulatory requirements in their Internet and social media activities…?

“ What are appropriate ways for Health Care Companies to fulfill regulatory requirements in their Internet and social media activities, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., micro-blogging platforms like Twitter, and mobile technology)?”

...should be required to make all regulatory-required information available one click away from their social media communications

...participating in social media should include a link to their product website in every communication

...should be allowed to present a shorter version of regulatory-required information when social media tools do not allow adequate space

...using real-time communications should be required to restate regulatory-required information in all their messages

...should not be allowed to participate in Internet and social media tools that don’t allow space for regulatory-required information

...should not be required to include regulatory-required information on social media platforms that cannot accommodate it

AGREE Health Care Companies…

NOTE: Fully visible data from this slide follows this annotated slide.

Health Activists voted strongly for a solution: nearly 72% wanted regulatory-required information available one click away from Company social media communications; 71% want companies to include a link to their product website in every social media communication.

Less than 18% were willing to say Companies need not be required to include regulatory-required information on social media platforms that cannot accommodate it. Fewer Health Activists felt comments should be regulated.

What are appropriate ways for Health Care Companies to fulfill regulatory requirements in their Internet and social media activities…?

“ What are appropriate ways for Health Care Companies to fulfill regulatory requirements in their Internet and social media activities, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., micro-blogging platforms like Twitter, and mobile technology)?”

...should be required to make all regulatory-required information available one click away from their social media communications

...participating in social media should include a link to their product website in every communication

...should be allowed to present a shorter version of regulatory-required information when social media tools do not allow adequate space

...using real-time communications should be required to restate regulatory-required information in all their messages

...should not be allowed to participate in Internet and social media tools that don’t allow space for regulatory-required information

...should not be required to include regulatory-required information on social media platforms that cannot accommodate it

AGREE Health Care Companies…

“On Hulu(.com), they do the Yaz commercial. So they do the one-click away link, and they do the regulation thing in the end of the video.

I don’t want to watch the last two minutes of this video with all the side effects to Yaz. But if you click anywhere on the screen it takes you to the Yaz website, it’s more information than if you talk to your doctor about it. It’s very thorough, I guess all within the FDA guidelines, and they’re covering everything you could probably think of from that video…”

--- Jennifer, WEGO Health Activist

Strategic Implication: Health Activists support fair balance – if it’s presented in a way that’s tailored to the online experience

Agree regulation of Health Care Companies’ participation in Internet and social media needs to be tailored to the unique attributes of the Internet and social media

74%

Agree open Internet and social media conversation between Health Care Companies and people online is valuable, and regulations should not prevent those open conversations

64%

How do you feel about regulation of Health Care Companies’ participation in Internet and social media?

WEGO Health Activists are passionate about the power of health social media – they see it as a powerful, new way to level the playing field for Companies and Consumers, and they understand the FDA’s challenge.

“It’s not like somebody has the upper hand, as it is in the case of TV advertising, where only companies with lots and lots of money get their voice heard on TV…people don’t have to have money and that kind of influence to be able to become a voice that is listened to in social media and the online world.

Which means there are a lot more voices and things are going to get debated, which hasn’t been the case in the kinds of media that the FDA is used to.”

--- Megan, WEGO Health Activist

Strategic Implication: Let’s work together – FDA, Health Care Companies and Health Activists – to develop guidance that works for us all

Companies, web sites and the FDA should monitor for Adverse Events, and provide simple means of reporting

“As to the issue of how much (companies) can monitor misinformation or monitor what’s being said about their product… they can devote resources to have people whose job is to monitor the Internet, find out what’s being said, and see what the appropriate response is.

We’re not talking about you or me, we’re talking about companies that are big enough and wealthy enough to make sure that what’s out there is accurate.”

--- Megan, WEGO Health Activist

The WEGO Health survey tool defined adverse events for Health Activists, including the four criteria for a reportable adverse event, as context for this section.

Keeping in mind the 4 elements that must be present…how often do you feel you see reportable adverse events online?

36% “sometimes” or “often”

Only 36% of Health Activists saw AE’s “sometimes”, which means once a month, or “often”, which means once a week.

Keeping in mind that these are hyper-active online WEGO Health opinion leaders, they are most likely to encounter adverse events.

Are you aware of a way for patients to report adverse events directly to the FDA?

52% “no”

Only about half of Health Activists were aware of direct-to-FDA reporting.

Do you feel Health Care Companies should actively monitor online conversations to seek possible adverse events?

51% “yes”

51% did feel that Health Care Companies should actively monitor online conversations to seek possible AEs – but 49% did not want Company monitoring, or just didn’t know.

Health Activists truly are of two minds on the topic of AE monitoring.

AGREE: Health Care Companies should respect that person’s anonymity and no report should be required

48%

DISAGREE: Health Care Companies should make every available effort to contact that person, using all available avenues to find contact information (e.g., querying ISPs to request the person’s email address)

47%

If a Health Care Company cannot identify the “patient” describing an adverse event online, what should the company do?

The source of concern is the definition of monitoring – and where it begins to overrun privacy.

If a Health Care Company cannot identify the “patient” describing an adverse event online, what should the company do?

Health Care Companies should encourage social media sites with health areas to post a clear, persistent link to an online form for reporting adverse events

An identified Health Care Company representative should post a link (e.g., in a comment or a wall post or a tweet) to an online form for reporting the adverse event

Health Care Companies should make their best effort to contact that person using the tools available within the social media platform where the adverse event was described (e.g., by sending a private message, by commenting on a blog post)

Health Care Companies should make their best effort to contact that person using other tools to find contact information (e.g., searching for contact information associated with that person’s screen name)

WEGO Health Activists support efforts to find AE reporters in social media, but only when those efforts preserve privacy – by communicating with an unidentified reporter only through the site where the AE was originally identified.

“Contacting them thru the same platform they posted the info on is one thing, but starting to Google search them, trying to track down their contact information…people could feel very violated, especially since people use screen names online to protect their anonymity…”

--- Lauren, WEGO Health Activist

Strategic Implication: Health Activists expect vigilance on adverse events – but within the boundaries of online convention, and not at the expense of privacy

It’s WEGO Health’s belief that the first companies to proactively seek AEs – to reach out to consumers on their terms, respectful of privacy – will be rewarded with appreciation and trust by the online community.

For more information about theWEGO Health Activist Social Media Survey or the

WEGO Health Activist Network:

www.wegohealth.com/socialmediasurvey

info@wegohealth.com