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Healthcare Privacy: Good or Bad? Discuss.

If you happened to be on the Internet, particularly Twitter, a couple weeks ago, you likely noticed the deluge of tweets about SXSW and requests from people to get you to vote for their session. Today, I wanted to share my session and spark a little debate. My session is all about why healthcare privacy will soon disappear and why we’ll all be healthier for it. More on that in a minute.

But first, in case you aren’t aware, SXSW is (now) a huge conference held each year in Austin that features interactive, music, and film portions. The sessions for this conference are in part selected by the votes and comments that the public leaves about them (they count for 30% of the selection criteria). So, you have a chance to dictate what goes on at this conference. Why should you care? Regardless of what industry you are in, I’d strongly recommend considering this conference next year. Last year was the first year that there was a strong contingent of healthcare related sessions and this year there will likely be even more. So, you can go and hear some great healthcare related talks. However, I’d recommend that you go to listen to everything else (assuming you work in healthcare everyday). Why? Well our healthcare industry could use a little outside influence from time to time just to see what’s possible and where we might be headed. If you only look at healthcare all day, you’ll never see “what’s next” until it’s too late.
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The 7 Golden Rules in Digital Relationship Marketing

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This is part two of a series on relationship marketing. Please check out the first post,  7 Biggest Mistakes in Digital Relationship Marketing, and make sure you’re not committing any of these before figuring out how to fix them. That post will also give you a bit more background on relationship marketing, but I’ll include a brief overview here as well.

[PS: If you're looking for more on my take of how relationship marketing and pharma fit together, then check out my white paper on "The Future of Digital Relationship Marketing in Pharma." It's the most downloaded white paper on Dose of Digital.]

Here’s our definition of relationship marketing (courtesy of our Chief Marketing Strategist, Bob Gilbreath):

“Relationship marketing is ongoing, direct, added-value communication.”

Ongoing: It’s a rhythm of regular, expected communication.

Direct: It doesn’t mean buying media, but owning it: You have permission to communicate, and it can be done in many forms.

Added Value: The marketing itself fills a need; usually, the greater the value to the customer, the greater the ROI.

That last one is important: “fills a need.” If you’re not doing that, then you’re probably just annoying your customers.

So, to ensure you’re not doing this, I’m going to share with you what I call the 7 Golden Rules of Digital Relationship Marketing. This is your list of “what to do.” Follow these seven rules and you’ll be well on your way to a very successful program.

One note, some people refer to relationship marketing as CRM, or customer relationship marketing (or management). For the purposes of this post, I’m saying they are the same thing.

So, here’s the list of what TO do:

7 Golden Rules in Digital Relationship Marketing

-

  1. Sharing, partnering, endorsing
  2. Perfect pitch
  3. Personalized and individualized
  4. Keep it simple, stupid
  5. Members only
  6. Personal investment
  7. It’s not about you

-

1. Sharing, partnering, endorsing

sharethisbox

If you are completely reliant on your own promotional efforts to increase enrollments in your program, then you’re missing a giant opportunity. At a bare minimum, you should include social sharing tools that make it easy for people to share your offers with others and encourage them to join your program. Incentive strategies, where you pay current members something for each new member they enroll, fit in here as well. Beyond social sharing, if your program is good enough, you can look towards industry groups and, in the case of healthcare, patient advocacy groups to grow your enrollment. If your program is valuable enough to their members, these groups will help you and will be your most effective enrollment tool. In the case of healthcare, physicians can become recruiters too if you show them how your program both benefits their patients and helps them to more easily manage these patients.

2. Perfect pitch


(Image from The Brand Builder Blog)

In order to keep people engaged over time, you have to communicate with them regularly (but not too regularly) and about things they care about at that moment. This is simple to achieve if you’re willing to do a little planning. Before building anything, plan out what you want to say and what channel you think is best to communicate it. From there figure out when it makes the most sense to communicate. For example, you probably should hold your stories about cold and flu until cold and flu season hits. Once you have these three pieces, then it’s simply a matter of laying it all out on a timeline.

Doing this accomplishes three things. First, it ensures that you’re covering your main points of communication and what your customers care about over a set time period. Second, it also serves as a commitment and motivation tool for you. Once you have it down in your timeline, you’re far more likely to actually do the work to launch the piece on time. It makes it far more tangible. Finally, having a quality timeline will help you make budget decisions should you receive more funding or (more likely) have some cut. You’ll be able to tell where you have additional capacity or where you can use some more.

3. Personalized and individualized

I’ve written about this before and spelled out what I think the difference is between these two terms (yes, there is a difference).

Personalization means adding some personally identifying information to your communications. This usually means putting someone’s name on the top of an email or direct mail piece. It’s remarkably simple to do with digital media and has become very simple (and cost effective) in print as well. Adding someone’s name to an email, for example, is much better than sending an email with “Dear Person” or “Dear Cancer Person.” I only joke because I have seen these before. I assume they were mistakes, but I saw them.

Individualization is something different. For our purposes, individualization means creating communications that are tailored for each and every individual person. The test to see if you’re sending out individualized messages is simple: does someone read what you sent and think, “Wow. They wrote this just for me.” If not, then it’s not individualized. This too can be really simple and more and more companies are embracing it. Here’s a great example that my colleague, Bob Gilbreath, wrote about on his Marketing with Meaning blog:

Delta Individualization Example

First, Delta included his name. Good. That’s personalization. However, then they go on and apologize for sticking him in a middle seat on his last flight and offer him some miles to say sorry. Interesting point to note, Bob didn’t ask for this or complain to Delta. They just did it. Delta knew the situation and sent an individualized response. Question: if Bob got this email and the 500 miles or another email that simply gave him 500 miles without the individualized touch, which would have more impact? Each results in the same value for him, 500 miles. But clearly the one that talks about his specific situation makes a lasting impression. So, you can’t just give away stuff and expect that to be enough. You have to make the extra effort to make it meaningful.

If you invest the time and effort to know what your customers are doing and what will be meaningful to them, then your communications will become more and more relevant to them. As they pass over hundreds of other emails they receive, but can’t remember why, yours will be the one that stands out.

4. Keep it simple, stupid

We marketers like to complicate stuff. One of these things I mentioned in the 7 Biggest Mistakes in Digital Relationship Marketing. It was number 4: Make it hard. Basically, if you make your enrollment process really difficult or make it a hugely daunting task to get any sort of individualized information, people just aren’t going to do it. So, you have to make it easy…simple, that is. Of course, our programs can be highly complex and necessitate a knowing a bunch of information in order to give good information back. That’s all right.

If your program requires a complex or lengthy process to yield the best information in return, you can’t just start with this. You need to start with a “light” version of your process to get people interested and engaged. Later on, you can add in something more complex once people are committed to your program and want to do even more with it.

For ConAgra Foods’ program Start Making Choices, our company (Bridge Worldwide), created two different ways to get individualized information. The first consists of just five questions on a simple slider bar design:

Start Making Choices Basic Survey

If people wanted the most individualized information (likely after seeing the quality information they received from the “light” survey) and their personal Balanced Life Index (BLI), then they are presented with a 23 question, multiple choice, survey. However, instead of making this question after question of text (or worse, 23 pages with one question each), we created an engaging design in which people swiftly entered all the relevant information. They did this because the questions were simple, but also the design kept them clicking and onto the next question, which kept dropout rates at a very low level.

Start Making Choices Full BLI Survey

5. Members only

Everyone likes being part of an exclusive club. They like the special perks that come along with membership and they like the prestige that comes with being a member. They like knowing that they’re getting something that everyone else can’t get. That’s just human nature. Do you belong to any clubs like this? Better question: do you wish you did?

Neiman Marcus InCircle

Take Neiman Marcus’ InCircle program. On the surface, it’s basically a rewards program. Spend this much, we give you this much. However, because it’s Neiman Marcus, they are also dealing with people who are members of a lot exclusive programs and for whom a $100 gift card isn’t that meaningful. Neiman Marcus needs to provide them much more. So, when you get to the President’s Circle (just spend $75,000 or more in a year), you get special offers that others don’t such as exclusive off-hour shopping events.

Not every program is like InCircle, but the concept is the same. You need to reward your customers who are part of your programs lavishly and regularly. They are your best customers, the ones that spend the most, and who talk about your products to others. They’re the most engaged, as evidenced by them joining your program in the first place. Keeping them your customer is an important priority. One note of caution, simply giving people incentives without changing their underlying attitude is one of the 7 Biggest Mistakes in Digital Relationship Marketing (number 5, Dollars don’t change everything).

Giving gifts to people in the healthcare space is pretty much prohibited either by company or government policy in most countries, so this makes it a bit more challenging. You have to think beyond gifts and consider things like access. This could be access to industry experts like, say, the leading physician in lung cancer treatment. If your patients are fighting lung cancer, they want to hear what this person has to say. Limiting it to members provides a special reward to those who have given you something (their business and trust) and also makes it possible to do more. You can do more because instead of spending $5 on a hundred thousand people to give them some tiny gift, you can spend the same amount and conduct a series of powerful programs (and even travel to where patients are). That’s just one example, but the point is clear. You can provide member benefits in any industry regardless of the specific regulations.

6. Personal investment

If people aren’t personally invested in your program, it’ll be a failure. Their investment is almost always their time (but can also be financial in the case of membership fees). Time is very valuable to people especially people who are fighting a disease. They don’t have time to invest on every website about their disease. They have to focus on one or two for the long-term and everything else is likely to be ignored.

People must invest their own time in order to be engaged with your program over time . There is only one way to get people to invest their time: give them something of value in exchange for their time. This doesn’t mean offering them rewards for coming back to your site or buying things. It means that your program should become more valuable to them for each minute they invest. A great example of this is Patients Like Me.

Patients Like Me Profile

The more information you provide about your disease (including tracking your progress and compliance with treatments everyday), the more you’ll learn about your disease. You’ll be able to track your progress against “the norm” and receive information on how to improve your situation. If you’re not willing to input this information up-front and over time, you won’t get much out of the site. However, if you are willing to do this, you receive a hugely valuable item in return: information on how to improve your health.

7. It’s not about you

This is a common sin committed by us marketers. I’ve talked about this before in the context of how to appropriately participate in social media. The same idea applies here. People inherently don’t care about your brand. Actually, they don’t care about your brand as much as you do. Because of this, creating a program that only features your brand is sure to be a failure. Instead, you need to balance your program with a mix of information about your brand and related information from which your customers are likely to get additional value.

P&G EverydaySolutions

P&G maintains one of the largest consumer databases in the world and is among the biggest users of relationship marketing. Our company works on Everyday Solutions, which is the central program for all of P&G’s products. It’s a single stop for brand offers and new product announcements, but there’s much more. There is also relevant content that matches with what each consumer has either said is an area or interest or whose behavior (pages visited, coupon offers redeemed, etc.) indicates that they are likely interested. In other words, people come to the site (or open emails or direct mail) not just for product offers and discounts, but also for other information. Those who initially come for offers see that there’s more to it than just a couple dollars off a certain purchase. This encourages them to return or to sign up for the program.

To be sure, the brands are prominently featured and are the focus of the program, but it’s not just one brand message after another. Every marketer wants to get in every core message at each customer “touch,” but that’s not necessarily a winning long-term strategy. There will be time for your messages if you can show people that your program is more than just a commercial.

Those are the 7 Golden Rules of Digital Relationship Marketing. Follow these and your program will be head and shoulders above nearly everything else out there. In case you missed them, be sure to check out the 7 Biggest Mistakes in Digital Relationship Marketing so you know what to avoid.

If you’d like a POWERPoint version of this, you’re in luck. You can download a copy of The 7 Golden Rules in Digital Relationship Marketing (811 downloads) right here. One request: if you do download it, how about sending out a tweet?

The 7 Biggest Mistakes in Digital Relationship Marketing

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For those of you who have heard me talk about my company, Bridge Worldwide, you know that I always say that we’re a digital AND relationship marketing agency. We’ve always been the latter, going back to 1979 (and the former for almost that long). It’s an important distinction to me. Digital agencies make a lot of cool stuff, but many lack the fundamental skills that are required to build lasting relationships with customers.  Of course, we can make cool stuff too (and win the biggest awards in the process), but we pride ourselves on being able to deliver the relationship marketing piece.

So, with that, I thought I’d share what I know and have learned about relationship marketing from working with some super talented people over the past few years and from the experience we’ve gathered from managing programs that now have more than 30 million total members. I should pause for a minute and, of course, mention that we think relationship marketing is evolving to something better called Marketing with Meaning. However, the basics of what makes relationship marketing REALLY work is embedded into Marketing with Meaning.

PS: If you’re looking for more on my take of how relationship marketing and pharma fit together, then check out my white paper on “The Future of Digital Relationship Marketing in Pharma.” It’s the most downloaded white paper on Dose of Digital.

To get started, relationship marketing isn’t this:

Just because you ask someone’s permission before bombarding them with ads, doesn’t mean you’re not still bombarding them (of course, no one is asked to”opt in” in Minority Report, where the clip above comes from). That’s not real relationship marketing. Here’s our definition of relationship marketing (courtesy of our Chief Marketing Strategist, Bob Gilbreath):

“Relationship marketing is ongoing, direct, added-value communication.”

Ongoing: It’s a rhythm of regular, expected communication.

Direct: It doesn’t mean buying media, but owning it: You have permission to communicate, and it can be done in many forms.

Added Value: The marketing itself fills a need; usually, the greater the value to the customer, the greater the ROI.

That last one is important: “fills a need.” If you’re not doing that, then you’re probably just annoying your customers.

So, to ensure you’re not doing this, I’m going to share with you what I consider the 7 Biggest Mistakes in Digital Relationship Marketing. If you’re doing any of these, stop now. Seriously…now. In a later post, I’ll share my 7 Golden Rules in Digital Relationship Marketing. That’ll be the list of “what TO do.”

One note, some people refer to relationship marketing as CRM, or customer relationship marketing (or management). For the purposes of this post, I’m saying they are the same thing.

So, here’s the list of what NOT to do:

7 Biggest Mistakes in Digital Relationship Marketing

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  1. No enrollment
  2. Program lapses
  3. Loss of interest
  4. Make it hard
  5. Dollars don’t solve everything
  6. No customer ownership
  7. All about the brand

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1.  No enrollment

Zero Enrollment

If your metrics for your program look like this, well, you can imagine that your program isn’t likely to be a success. While having more enrollments in your program doesn’t mean that your program is better than one with less, low enrollment numbers (i.e., well below your target) does indicate a larger problem. This problem can be a number of things, but it usually points to a lack of commitment in the program by some function within the organization. Presumably, you set your targets based on solid estimates and extrapolations. Perhaps it was a certain percentage of people who visited your website. Well, if “corporate” pulls funding for all the traffic drivers to your website, then you aren’t going to hit your target for enrollments either in this example. If you have a bunch of enrollments followed by a bunch of opt-outs, then your program just might be bad (or commit a number of the sins below).

Figure out why and fix it.

2. Program lapses

Nothing annoys me more than this one. I enroll in your program and one of two things happen. Either you send me a welcome email or direct mail right away and then I don’t hear from you for months or you don’t send me anything initially and three months later send me the first correspondence. If you’re doing this, then don’t even bother continuing. Put yourself in your customers’ position. They probably get a lot of email that appears to be junk everyday. If an email for a program they signed up for three months ago and have long forgotten shows up, how do they react? <DELETE>. And that’s your best case. Worst case, they’ve literally completely forgotten about signing up for this program and think that your message is unsolicited spam. They report that spam to, say, Google (via their Gmail account) and before you know it, Google thinks you’re a spammer. Not good.

3. Loss of interest

This is somewhat related to number two above, but has an entire other component as well. If you never send me anything, I’m going to forget why I spent the time signing up in the first place. I’ve moved on. I probably signed up for your competitors’ programs too and if one of them is taking care of me and I’m using their products too.

And to illustrate why it’s so simple to lose interest in your program, I’d like to show you a random day from my Gmail inbox. I chose July 16 because right now I miss the summer. Here’s what it looked like:

My Cluttered Gmail Inbox

Almost all of the emails I got that day were for programs I have signed up for at some point. You’ll also notice that I didn’t open a single one of the emails. That’s what I mean by “loss of interest.” Why did I lose interest? Simple: if your offers and correspondence are always the same, people forget why they signed up in the first place. Something interested them. Something sparked a touch of excitement. That’s long gone and they aren’t even opening your emails anymore.

4. Make it hard

There’s no better way to kill your program than to make the enrollment process a pain. Someone sent a screenshot to me of this form a while back (they can’t recall where they found it, so if it’s yours, speak up and I’ll give you the credit).

Worst program enrollment form?

It’s a perfect example of what I like to call an “are you kidding me?” form (usually I put an expletive in there as well). An “are you kidding me?” form is one that a person takes one look at, says, “are you kidding me?” and clicks onto a different site. If your enrollment process makes someone say “are you kidding me?” then change it immediately. Keep in mind that you don’t need to know everything about the person at the beginning. Think about it as though it’s a first date. If you asked all the questions you ask on your “are you kidding me?” form, then you wouldn’t have many second dates. Instead, get the basics now and later on collect more information. Remind people that the more they tell you, the more tailored your offers will be (they will be tailored, right?). Then deliver this. The more the customer sees this, the more information they’ll share. And, by the way, you don’t get a pass by making your two thousand, initial profile questions “optional.” Just the sight of them or the thought that one day they’ll HAVE to answer them to get anything useful from this program, is enough to turn people off.

5. Dollars don’t change everything

Hold onto your hats, this one’s a bit technical. For those psychology experts out there, you’ll love this one. The main idea here is that simply “bribing” your customers via more and more offers or discounts over time isn’t likely to be a winning long-term strategy. The reason for this is simple. First, you have to keep increasing the offers to keep these people interested, which will eventually bankrupt you. If it doesn’t bankrupt you, it’s because you’ve withdrawn the best offers and likely lost a ton of very unhappy customers.

So, why, you might ask yourself, do people who previously have been given so much instantly desert me when I stop the offers? This is simple and, ironically, it turns out that those who are offered less, will likely be the ones who stay with you forever even when you take away their small offers. It’s a classic case of cognitive dissonance at work. In this case, your loss of customers is explained because you never changed their attitude towards your products. You only changed their behavior because of the money (or other offers) you gave them. When you take away the incentive, you’re left with the same attitude they’ve always had, which means they go back to the original behavior (i.e., not buying your products). This phenomenon is called the Point of Minimum Justification (which is explained really well in one of my favorite business books: Universal Principles of Design). It’s illustrated like this:

Point of minimum justification

As you increase incentives, you change behavior (red line). This is the idea behind “everyone has their price.” That is, for the right amount of money, people will do almost anything. The blue line shows how attitude changes with increasing incentives. It too increases at first with increasing incentives, but eventually disappears. Attitude here is your attitude to the product or service (or situation). An increase in attitude on this chart symbolizes a positive change and you want people with a higher, positive attitude towards your product.

Why does this graph look like it does? Simple. When you give people a lot of money to do something, they justify doing it because of the money and NOT because they think what they are doing is a good or enjoyable thing. On the other hand, if you give people very little incentive to do something and they start doing it, they justify the reason for doing it because they believe that what they are doing is a good or enjoyable thing. It’s all because of cognitive dissonance. In the case of a product being marketed through relationship marketing, increasing your incentives will get people to use your product because they are simply taking advantage of your incentives. When the incentives are gone, so are they. On the other hand, having just the right incentives causes people to truly consider why they are using your product. They become more invested and perhaps learn more about what makes it so great and even become advocates. Since they aren’t justifying using your product because of incentives, they justify it in other ways.

The point at which you can provide the smallest incentive with the greatest change in behavior AND attitude is the point of minimum justification. It’s what you want to shoot for in your program. In the case of pharma, I see too many new adherence programs relying soley incentives to keep people on the drug. This isn’t a winning strategy. For people to truly want to continue their treatment, they need to understand why they are taking it and the risks and benefits. If they’re just taking it to collect your incentives, then they aren’t doing this. You’re not changing attitude, which won’t be effective over time.

For more on where this concept was born, check out the Wikipedia article explaining Festinger and Carlsmith’s classic experiment back in 1959.

6. No customer ownership

If I have nothing invested in your program, then I’m not going to continue with it. My investment is usually my time and if I haven’t given you this, then I’m not going to be a part of your program for long. However, be careful that you don’t create this investment while you commit sin #4, Make it hard. Don’t create work for people just so they waste their time. That’ll get them to quit your program really quickly. Instead, find ways to ensure people’s time investment yields them something of value. Consider the time people invest in tracking their runs via Nike+. It would be hard for another competitor to come along and steal away any regular user of this program simply because they have so much invested. They’d have to start from scratch and they’d lose all the “credit” for all the runs they’ve done, lose all connections to people they’ve challenged, plus having to learn a new system. Nike+, of course, gives great information back in exchange, so people feel that their time investment is worthwhile and at the same time, they make it harder and harder for themselves to leave the program each day.

AOL enrollment CD

Remember these things? They were everywhere for a long time. What made this so effective is that AOL realized the more free time they give, the more likely you are to stay with them when you run out of free time. Why? Simple. You’ve invested so much time into it by the time 1,000 hours (or 45 days) rolls around. You’ve got an email address you’ve shared with others, a profile that took a long time to get just right, friends who you IM…you’re not leaving all of that. AOL used this concept perfectly and became the largest ISP almost overnight. Of course, if your service stinks, then no amount of investment will keep people forever.

7. All about the brand

People don’t inherently care about your brand. The sooner you recognize that, the better. Certainly, this is true for most pharma brands. And, while some brands might have an almost cult following (Apple, Harley, etc.), most brands don’t have this luxury. Because of this, your program has to offer more than just a connection with your brand. There are already so many other programs out there connected to specific brands and stores that people lose track. Instead of getting overwhelmed, they just drop everyone. Does your stack of loyalty cards look like this?

loyalty cards

Do you think any of these stand out from any other? Is it any wonder why people never have their card when the cashier asks?

To stand out, you program has to offer more. It has to be more than just the product. Nike+ isn’t all about Nike’s products. It comes with a valuable service that makes me (all right, makes other people) better runners and, in turn, healthier.

So, those are the 7 Biggest Mistakes in Digital Relationship Marketing. Steer clear from these and your program is already far ahead of most that are out there. Coming soon, I’ll share the 7 Golden Rules in Digital Relationship Marketing, which will highlight what you SHOULD be doing to make your program a success.

If you’d like a POWERPoint version of today’s post, you’re in luck. You can download a copy of The 7 Biggest Mistakes in Digital Relationship Marketing (783 downloads) right here. One request: if you do download it, how about sending out a tweet?

166 Reportable Adverse Events Equals One Red Herring

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With just a few days until the long awaited FDA hearings on pharma’s use of social media, the buzz in our little community has certainly picked up. Heck, there’s even a site to track it all courtesy of Fabio Gratton. If you want the latest about these hearings, this site is a pretty good place to start. You can get a bunch of logistics information, see the Twitter buzz, and even download the presentations of those people who have made them available (you can get mine here).

It’s all great. We’re finally going to have some guidelines around social media, which we all have been clamoring about for a long time.

Enter the cynic part of me. I’m not so sure that most people are going to be happy with the results of this meeting. I was talking with a client yesterday who asked if I expected the guidelines to be vague/ambiguous or specific. Presumably, the latter being preferable to marketers. Of course, the guidelines can’t really be specific. For example, they can’t say, “Do this, this and this on Twitter, but not this and that.” The guidelines HAVE to be vague otherwise they’ll be outdated next year as the technology changes. I wouldn’t have it any other way. Ultra-specific and highly directive guidelines is not what you want…trust me. Don’t you already have that with everything else? Have you seen a pharma print ad recently?

Boniva Readers' Digest July 2009

That’s 40% ad and 60% fair balance. Do you need more rules like this?

My point is here is that slightly ambiguous rules, will allow many marketers to continue to justify their lack of participation in social media. Sure, nevermind that their peers are already doing quite a lot (see it all on the Pharma Social Media Wiki). Doesn’t matter. They’ve always had one objection and they’ll continue to have it.

That’s right, you guessed it: “adverse events.”

I’ll say this, if I never hear the words “adverse events” from another brand marketer, I’ll live my life out a much happier and less stressed person. When I was a brand manager and social media really wasn’t all the rage as it is today, I don’t think I ever said “adverse event” one time in three years in the context of reporting. It was something that happened and we had a whole team just to handle them, but I didn’t concern myself too much with them as a marketer (thankfully, on a product with very, very few reported adverse events).I relied on more classic “rationale” when I didn’t want to do something…you know, things like “no budget,” “regulatory,” and “ROI.”

But now, that there’s social media, it’s a whole new set of “rationale.” Of course, the one that rises to the top is adverse events. To figure out a bit more about this, I informally asked some pharma marketing people about what they thought “adverse events,” specifically “reportable adverse events,” really were and was pretty surprised by the results. None of the five I asked knew the completely accurate answer. I realized that this might be part of the problem.

It became clear to me and I crafted this analogy: Being afraid of “adverse events” in social media is like being afraid of swimming right after you eat.

Someone always told you that if you went swimming right after you ate that you’d cramp up and sink like a stone and drown a horrible, if sated, death. Except you won’t. No one knows where this “old wives tale” came from or certainly the scientific proof for it, but yet it persists. There’s probably a hint of science in there…maybe you’re body is spending resources digesting the food that would ordinarily be used to help you swim, so therefore…well, you can see how these things happen. Same thing with adverse event reporting…someone heard that one time someone posted an adverse event on a website and a pharma employee saw it and didn’t report it. This employee was subsequently tarred and feathered, fired, spent 12 months in real prison (no white collar stuff) and the company was fined $1 billion.

Ah, urban legends.

So, knowing that there’s a bit of a misunderstanding about adverse event reporting, I’m going to clear it up with some good old-fashioned numbers that I know your average marketer (myself included) can relate to. When the guidelines come back from the FDA and you don’t like them, you won’t have the whole adverse event issue to hide behind anymore. If you still want that security blanket, then stop reading now.

[Important safety tip: I am not an attorney, much less your attorney, so this should not be considered legal advice.]

By now, everyone has seen Nielsen’s report on the incidence of reportable adverse events on health-related sites. If you haven’t, get the paper now. In summary, Nielsen pulled out 500 random posts from the massive amount that they monitor (more on that in a minute). They then analyzed these to see if any of them had a “reportable adverse event.” What do you need to have a “reportable adverse event”? Simple. You need four things: an identifiable patient, an identifiable reporter, a specific drug or biologic involved in the event, and an adverse event or fatal outcome. If you don’t have all four, don’t bother submitting it because the FDA won’t accept it. In their words, “[Without these four pieces] a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances.” [ital. added]

Of the 500 posts Nielsen reviewed, only one (yes, 1) had all four criteria. That’s 0.2% for those scoring at home. So, 0.2% of all posts, should contain a reportable adverse event. Impossible you say? Here’s why it’s so low: the rate-limiting factor here isn’t what many people think. It’s not that the, say, identifiable patient piece is difficult because of the anonymity of the Internet, for example. It’s much simpler than that. Most of what you might think is an “event” is not required to be reported.

In the Nielsen study, they looked for events that would need to be reported within 15 days of receipt per FDA regulations. These are the most serious events and have the strictest reporting standards. Events that must be reported within 15 days are those that are BOTH serious/life-threatening AND “unexpected.” The former is pretty simple and includes outcomes such as “death, a life-threatening…experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.” The latter, “unexpected,” is a bit trickier, but also is pretty straight forward. “Unexpected” is  “any adverse drug experience that is not listed in the current labeling for the drug product.” [Read the full code on FDA's site]

This means that if someone reports they got a headache while taking your drug, for example, and headache is listed in your labeling as a known side effect, then you do not need to report this in 15 days or any other day. If, on the other hand, they report that their hair fell out and that’s not in your label, then it might be reportable since it’s “unexpected.” However, it’s not serious or life threatenting, so it would not be required to be reported within 15 days. Events that are EITHER serious/life-threatening OR “unexpected” need to be periodically reported to FDA (hint: you’re already doing this). Drugs launched in the three previous years needs need to do quarterly updates on these types of events. Those drugs that have been around longer than three years need to do annual reports. For the purposes of this discussion, I’m really only considering the events that would fall under the 15-day rule (as did Nielsen), as these are the ones that are most labor intensive and require immediate attention. Those that fall outside this rule can use your normal channels for reporting back to FDA, which you’re doing already.

Most of the confusion I’ve seen is around this issue is around defining exactly what qualifies as an adverse event that requires action. I mentioned already that only 1 posting in the 500 Nielsen reviewed met all four criteria including the adverse event part. However, I asked Nielsen for a bit more information on this and got some great help from my colleague at Nielsen, Melissa Davies. She informed me that only 4 of the 500 posts had events that were reportable under the 15-day rule (i.e., an event that was BOTH serious/life-threatening AND “unexpected.”) . Three of these were missing one of the other criteria required for reporting, so you’re left with one in 500.  I’ve heard a bunch of debate about this study because it doesn’t consider some companies’ required due diligence around investigating reports that are missing one of the four components. For example, there might a company policy that says you must investigate to find a reporter’s name including sending them a direct message or email from the site where the event was posted. Nielsen didn’t (and shouldn’t) account for every company’s policy on this.

However, regardless of your due diligence policy, you can’t report something that didn’t happen. If there’s no adverse event, it doesn’t matter if you have the other three pieces or not. Show’s over. No need to go further. So, the way I see it, the absolute worst case scenario is that only 4 out of 500 posts are potentially reportable, which is 0.8%. That’s not a big number, of course, but how many posts are there every day? That would tell you how many potentially reportable adverse events there are in a month or year.

Nielsen shared with me a bunch of data for my FDA testimony. They shared that their BuzzMetrics product regularly scans more than 100 million sites. Around 1,350 of these are healthcare-specific and have some discussion component to them (blogs, forums, Q&A, etc.). These 1,350 generate almost 83,000 new posts each DAY.

Here comes the math:

Math problem #1: Multiply the total number of posts per day by the number of posts that contain adverse events that are both serious/life-threatening AND unexpected and have the other three criteria required for an adverse event  = adverse events generated per day that need to be reported in 15 days to the FDA.

Math problem #1 answer: 83,000 X 0.2% = 166

If you want to use the more conservative number…

Math problem #2: Multiply the total number of posts per day by the number of posts that contain adverse events that are both serious/life-threatening AND unexpected, but do not necessarily have one or more of other three criteria to have a reportable event =  the maximum number of adverse events generated per day that need to be reported in 15 days to the FDA.

Math problem #2 answer: 83,000 X 0.8% = 644

Let me put that to you another way…the ENTIRE PHARMA INDUSTRY, assuming they were responsible for EVERY SINGLE discussion online, would have to manage 166 reportable adverse events per day. Divide that out across the number of companies out and there’s not a lot of work for people to do.

Of course, you are not required to monitor everything out there and you only have to report events that are reported to you (which would include posts or comments on sites you manage or control) or events that you come across elsewhere online. Unless you’re a really fast searcher, then you’re probably not going to read through 83,000 posts a day (hint: that’s about one per second). If you only concentrate on your little neck of the woods, then you might never come across a reportable adverse event in months. How many posts or comments does your social media program get? Looking at what’s out there, not many. So, if it takes 500 posts to see one, then you might not see one in your lifetime.

The point of all this is simple. Are we really holding back everything there is to gain from properly engaging in social media because of 166 reportable events a day? Does that add up for anyone else?

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