I recently wrote a detailed wrap-up of the hearings (link to article at the end of this post) and in thinking back on my experience I perceived three broad themes:

1. The need for “radical simplification”
2. The potential of technology to improve the dialogue
3. The limits of pharma responsibility

The need for “radical simplification”

The current behavior for pharma when it comes to online advertising is to stuff as much disclaimer and Important Safety Information (ISI) into an ad to ensure the pharma company is “covered.” Think about it – have you ever read the entire privacy policy of a website or the terms and conditions for your credit card? Likely not. The same goes for ISI. How is it really helping patients?

Instead of just saying simplification is needed, Google presented a potential solution for search and I offered an idea for how to handle display ads. Our ideas were developed independently, but ended up in a remarkably similar place: reduce information to the most important details for consumers and then allow them to click-thru for the full information. (You can see the actual examples in my wrap-up article below.)

Quite simply, less is more.

The potential of technology to improve the dialogue

In general, pharma tends to handle the digital environment by transferring offline techniques to the online space without thinking about the unique characteristics and potential of the internet (think e-detailing, Websites that look like prints ads, and the mountain of ISI data we’ve been discussing). Some of this is due to a lack of innovation, but a good deal of it is to ensure they are complying with FDA requirements – even though none exist for the Internet (hence the hearings). Guessing leads to clunky solutions.

Yahoo presented some innovative ideas for tackling the safety issue, taking these unique characteristics into account. They suggested pop-up windows that include ISI and video solutions playable directly from search ads, giving users unlimited time to see as much information as they want which can only improve consumer comprehension.

The limits of pharma responsibility

No topic was hotter than the freedom and responsibility of the pharma industry to participate in social media conversations about its products. Several speakers presented original research prepared for the hearings to gauge consumer and HCP interest in pharma’s participation and a strong majority showed they would welcome pharma’s involvement. Of course, not everyone agreed, with one speaker suggesting pharma should even be held responsible for monitoring Wikipedia (yowza).

There was also a lot of talk regarding adverse event (AE) reporting – one of the top concerns for pharma. One speaker noted a small percentage of social media comments would actually qualify as AEs and others noted that pharma cannot possibly handle monitoring all these conversations from a resource perspective.

In my opinion, both these arguments are shortsighted. First off, software tools can scan the Web and uncover significant mention of a product and those comments can be categorized and reviewed (we do this regularly for clients).

But even more importantly, why put such a restriction on what a “qualified” AE means? It would seem critical to pharma’s business to know exactly the issues being reported so they can investigate, assess and correct. This could likely improve patient outcomes AND the opinion of pharma in the court of public opinion.

Find my full wrap-up of the hearings here.

In addition, you can access a video of my two presentations at the hearings here (PC format only) .

The following is the introduction to a new whitepaper from Heartbeat Digital:

Five years from now, people may look back the Fall of 2009 as the season that
finally changed the world of healthcare social media. That’s because of two
recent events that may disrupt the social media landscape for pharma, perhaps
permanently.

The first was Google’s introduction of Sidewiki as part of its latest toolbar
download. For the three or four people who may have missed the volley of
alarmed emails that followed the announcement, Sidewiki allows anyone using
the Google toolbar to comment on any website, without asking any permission.
The comments appear on the side of the Web page in question (thus the name).
They can be seen by anyone else who has installed the Google toolbar, and they
can’t be removed by the site owner. Call it “Social Media, Like it or Not.”

The second event is the FDA’s public hearings on November 12 and 13 on “the continually evolving nature of the internet, including Web 2.0 and social-media tools, as well as their expansion to applications such as mobile technology.” A pretty big digital grab-bag there, but from the nature of FDA’s specific questions, it seems clear that the agency is most interested in the implications of social media (note: the author has been invited to present his point-of-view at the hearings.)

The FDA’s decision to seek guidance is newsworthy for several reasons. First,
because the FDA has never, ever done so before when it comes to the Internet,
opting instead to answer questions as they came up from pharma companies, or
to merely have people guess what the agency’s position might be. Second, it
indicates that the FDA is taking Web 2.0 much more seriously than it had before,
perhaps – just perhaps – realizing that it represents a major advance in patient
communications about medicines and other healthcare topics.

This is potentially very good news. For without clear guidelines, pharma has
been wrapped in a social media straitjacket. The industry’s efforts so far have
been extremely constricted because they are not sure whether they will be held
accountable for rogue comments, including possible adverse events or off-label
claims.

Taken together, the invention of Sidewiki and the attention of the FDA may
fundamentally alter how drug manufacturers participate in social media
conversations. Sidewiki may force companies to finally participate; the FDA may
enable it. But what should you do about it?

(Please download and read the rest of this whitepaper here.)

It’s good news, and potentially a much broader story than most commentators have recognized so far.

While attention has focused on social media, the announcement actually refers to “Internet and social media promotion.” I’m not sure most people realize that FDA has never issued guidelines on any use of the Internet – more than ten years after the first pharma Websites were launched. Is a Website primarily informational, like a package insert? Is it primarily promotional, like a print ad or television commercial? Is it something in between? Pharma marketers have had to guess and pray they didn’t get a warning letter.

So it’s a good thing that FDA is finally stepping up; now we have to hope they do so with vision and clarity, especially when it comes to the rich possibilities of social media. In the absence of FDA guidance, pharma marketers have been pretty much paralyzed in their approach to Facebook, Twitter, and their other new media cousins.

There is nary an example of anything but non-social, social media – meaning sites have been constructed on Facebook and elsewhere with the interactive parts almost entirely neutered.

If FDA takes a stand that allows pharma marketers to interact with patients, physicians, and caregivers in a valuable, authentic way, enabling them to help improve the healthcare dialogue – without holding them responsible for the occasional wayward or wacky comment from an unleashed member of the public – it will be doing a real service to us all.

And if at the same time they finally clarify the rules about branded and non-branded Websites, FDA will be enabling pharma companies to deploy the Web’s unique power to inform the public and promote their products – safely and effectively.

It will affect health portals in a couple of ways. The limitation on search ads will force marketers to spend more on display ads, where they don’t have the same character limitations as in Google ads. So the net effect will be an increase in demand for display media units in general, which should have a positive impact on health portal revenue.

But there may be a less obvious effect as well – accelerating the movement away from branded ad units in general (whether in search ads or display) and towards disease-state content that then drives to a richer brand experience. There are a number of advantages to this approach: It requires far fewer restrictions to the content, it gains much higher response rates, and it sets up the conversation properly for the patient so that they are prepared for the branded message when it is exposed to them.

There have been two schools of thought on this question, and both, I think, have gotten it wrong so far.

Before I get to what I believe is a better way forward, some background: Facebook just surpassed 200 million members, and Twitter experienced 1,100% growth in just the last year alone –  so it’s become impossible for pharma companies to ignore the social media channel any longer.

But as companies begin to monitor social conversations, many have been flummoxed by the question of how to handle possible adverse events.

One well-publicized school of thought takes the following position:

“In most cases, social media monitoring will not result in reportable events as the
required identifiers will not be available in a verifiable manner. Postings on chat rooms or other social media outlets will typically not contain enough information to warrant an obligation or a prudent need to act further.”*

But this would be a very dangerous position for a responsible pharmaceutical company to take.  In the court of public opinion (and indeed, in a court of law) the defense that, “We knew about these things but weren’t technically required to report them,” will be, well, indefensible.

The other school of thought is what I call “the ostrich approach.” Some companies seem to be taking the position that,“If we ignore social media, maybe it will go away.” That won’t fly either, since the public (and regulators and perhaps Congress) will expect  a responsible company to pay attention to what patients, caregivers, and physicians may be saying about their products.

In my view, the best approach to AEs is a two-part process I call, conveniently, “AE”  for Awareness and Engagement. You shouldn’t forego the value of social monitoring – it can give you an unrivaled lens onto the perceptions, unmet needs and mindspace of your key customers. And you don’t want to ignore the bad stuff either. In fact, if a patient is publicly expressing a problem with your product, isn’t it worse if you are the only company unaware of it? So awareness is crucial.

And part two – engagement  – is equally essential.  If you see what may be an AE – even if the post is not ‘technically’  an AE – you should make a good faith attempt to contact the person, identify your role as a company representative, express your concern, and give that person a discreet way to discuss the matter in private with an appropriate company representative. Will the person agree to engage? Perhaps not, but you will have certainly made a good-faith effort to act responsibly, for the good of your patient, and your reputation.

*”Connecting with Patients, Overcoming Uncertainty,”  TNS media intelligence Cymfony, Envision Solutions LLC, Seyfarth Shaw LLP, September 2007

The FDA’s recent crackdown will certainly change ‘business-as-usual’ in search marketing. But in the end we think that’s a good thing.

I will explain. The FDA’s action — requiring complete fair balance if there is anything that can be construed as a claim in a sponsored link — will effectively kill the use of claim-including sponsored links on Google and other search engines. Because Google limits search ad copy to a total of 95 characters, it will be impossible to include complete fair balance in the ad.

But the effectiveness of branded sponsored links was already so poor that we don’t think pharma marketers are really losing very much. Squeezing a claim into the ad may have made marketers think they were effectively messagining their audience, but the data showed otherwise. Branded advertisements of this sort have been woeful performers in terms of click-through rates — the key metric for a search ad. In fact, we have found that non-branded ads — addressing the disease state rather than the brand’s direct messeage — perform up to 3x better than branded messages. So it has actually been more effective (and cost effective) to use non-branded search ads to drive people to an branded website, where branded information can be delivered more completely, including a fulsome explication of fair balance.

Think of it this way — if the consumer is already familiar enough with the condition to be receptive to branded advertising, just giving them the brand name, and noting that it is FDA approved for the condition, should be enough to get them to investigage further. (And we don’t think theFDA’s new position that would prevent this.) But if the consumer is not well-versed in the condition, she is not prepared for a branded communication in the first place. That’s why non branded search ads perform so much better.

So although it was not the intention of the FDA to make pharma companies smarter search marketers, that may indeed be the effect.

No question is generating more attention (and confusion) these days than this one: “What is our social media strategy?”

More often than not, the question is coming from senior management, usually after the CEO observes his teenage children holed up in their bedrooms through weekend mealtimes on something called Facespace, or MyBook, or  …  something.

But there are serious reasons to take social media seriously. Facebook boasts 175 million active users, and is growing at the rate of 5 million new users …  a week! And it’s not just the traffic numbers that astound:  according to ComScore, Facebook users average more than 2½ hours on the site every month. Marketing nirvana, you would think.

Well, not quite. While the audience is huge, it is singularly uninterested in your advertising.  Click-through rates (CTR), a standard measure of online ad effectiveness, are gnat-like. CTR on Facebook have been reported to be 0.04% – dramatically lower than the online industry average of 0.21% listed by MarketingSherpa.

So what’s a pharma marketer to do?  Rethink your approach. When you place an ad on my page, you are seen as an intruder on a conversation to which you have not been invited. You need to respect the conventions of the social media universe and ask to participate.

Brands that have taken this approach have done well. The best pharma example is “Take a Step Against Cervical Cancer”, sponsored by Merck in support of Gardasil, its cervical cancer vaccine. This is not an ad campaign – it’s a lightly branded Facebook mini-site that encourages people to help end cervical cancer, and along the way, learn about the Merck vaccine. The site has been friended by more than 100,000 Facebookers, by far the largest community built by a pharma company in the Facebook universe.

Alas, the good examples are rare. To create the next social media success story, keep three things in mind:

1)    Social media is about engagement, not advertising
2)    The user is in control
3)    As your mother would say, be polite when you’re visiting someone else’s place