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EVERYBODY PANIC! Overcoming Cultures of Fear in the Age of the Attention Economy

Prior to joining WPP, I had the experience of working at an agency that was in the midst of trying to change from a traditional mindset to one more focused on digital and emerging technologies. What was fascinating to me was not how resistant our clients were to this change, but how flummoxed the internal culture was by these deviations from the ‘norm’. In ways that I could have never anticipated, I watched people react irrationally and illogically to the pending ‘threat’ of change, oftentimes based on assumptions that were never based in reality.

Pharma has this same issue. It’s terrified of change. I mean mortally terrified. And that presents a problem because, as we all know, change is inevitable. In ways you may not realize, the inherent terror that pervades the industry may be the reason why innovations fail to take root on a consistent basis.

Think about it. All innovations have change as the underlying common denominator. Since most people working in the digital, social or the technology fields are often asked to be agents-of-change, we deal with the results of fear-based risk-assessment all the time. Too often in that process, discussions will drift to analyzing the consequences of sometimes wildly speculative assumptions in order to determine what the worst-case scenario may be. When conversations head down the fear path, they are rarely productive.

So as innovators how do we overcome these sometimes-irrational responses? Are there better ways to evangelize new ideas? Will more data or facts help correct the problem? Hopefully better understanding the causes will better arm us all to more effectively drive change.

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Lies, Damn Lies, and Pharma Social Media Statistics

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Somewhere along the way, I began to notice that I developed a really low tolerance for the abuse of legitimate research and statistics in an effort to garner a great headline. When I see these headlines, I’m usually among the first to dig into the “research” and figure out the real story. What’s missing? What methods were used? Do the actual conclusions match the headlines? A favorite of mine is the chart at the top of this post (courtesy of the P.A.P. Blog). Not every headline purported to be backed by statistics makes sense even if it appears to on the surface. This one appears to show that increasing the number of lemons imported to the US from Mexico reduces highway fatalities.
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Monitoring Adverse Events in Social Media for Pharma’s Biggest Brands: Hopeless Task or Simple Project?

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Hopeless Task?

Today’s post was co-written with Melissa Davies, Healthcare Research Director at Nielsen in the Online Division.

Key Points Summary (detailed post follows)

  • Reportable adverse events are far less common than most people suspect. There are only approximately 166 reportable adverse events per day recorded across the entire pharma industry.
  • Even for the biggest pharma brands, there are very few discussion happening online that include a mention about the brand. Only 36 per day for the biggest selling drug in the world, Lipitor.
  • When you consider the number of discussions that might have a reportable adverse event, it would take a long time to find one for most brands. For example, you can expect one reportable adverse event every 2 weeks for Lipitor (for the site monitored in this study).
  • For many pharma companies, it would be difficult, but not impossible to do this monitoring in house, as some automatic filtering could simplify things. Using call center employees, who are already trained in how to handle these discussions makes sense.
  • There are three categories of discussions that need to be screened: those you could skim past relatively quickly, those that might give pause for thought but could probably be filed away or handled with pre-approved response language, and those that may require escalation depending on the company’s social media and customer response policies. The time required to screen all discussions depends on the mix of these categories.
  • Companies need to determine what and why they are monitoring. This means determining if you’ll monitor only your sites or which 3rd party sites as well. Finding adverse events isn’t the only reason. Correcting misinformation, understanding patient needs, and engaging in dialogue (e.g., answering questions) are also reasons.
  • If companies are only monitoring their properties, expect a very low number of discussions and even few discussions that might be considered reportable adverse events.

Detailed Post

In a first for Dose of Digital, today’s post was co-written with Melissa Davies, Healthcare Research Director at Nielsen in the Online Division. Not familiar with Melissa, you say? I bet you’re familiar with her work especially if you’re  a regular reader of this blog. Melissa was the lead author for the now famous “1 in 500″ white paper about the incidence of adverse events (AEs) in social media. This is the report that showed the Internet isn’t chock full of reportable adverse events just waiting for the first unsuspecting pharma company to happen by and be crushed by the deluge. Rather, Melissa and her team’s work showed that only 1 in 500 (0.2%) randomly selected discussions (blogs, comments, forum posts, etc.) contained all four criteria required by the FDA to be considered a reportable adverse event. If you want more detail on this then check out my post The Myth of Adverse Event Reporting and definitely get the original paper (PDF) from Nielsen now as well.

Those are some pretty strong credentials to help me out with a follow up to my recent post 166 Reportable Adverse Events Equals One Red Herring. To create that post, I asked Melissa to supply some more information about the original Nielsen study. The reason for this is because in discussions with many people from the pharma industry, I discovered that many knew the “1 in 500″ stat, but remained concerned about the volume of AEs out there. Their rationale was simple: 0.2% of, say, 50 billion is still a pretty big number. Without knowing the number of total discussions, the 0.2% number doesn’t mean much. That meant figuring out how many new discussions are generated each day (and it’s not 50 billion).

The answer came from Melissa, who dug a bit into Nielsen’s database to answer a seemingly simple question: how many new pieces of healthcare-related content are generated each day online? Nielsen monitors 1,350 sites that it considers to be healthcare-specific (and millions of non-healthcare sites too). Looking at these 1,350 sites over time showed that, on average, there are more than 83,000 new pieces of content generated each day on these healthcare-specific sites. So, at least we know it’s not 50 billion.

That was the inspiration for my post. 0.2% X 83,000 = 166. There are 166 reportable adverse events generated each day for the entire pharma industry to handle. 166 isn’t a lot to me when you divide the work to manage these events across all the companies out there. Yes, larger companies are likely to have more and controversial products might also have more, but 166 for everyone to share is a pretty manageable number.

Almost immediately after this post went live, I was contacted by several pharma companies looking for some more information. Specifically, many weren’t convinced that it was quite this simple. That is, it may be one thing for Nielsen to scan through 500 messages and come up with 0.2% and to show the total volume, but it’s quite another for a pharma company to screen the more than 83,000 new pieces of content by hand themselves each day. How could one company possibly screen every single one of these pieces of content each day to find the few bits that refer to their products? What time commitment would be required to find these needles in all these virtual haystacks? When it comes to a particular brand, should they expect to find a few adverse events? Dozens? Hundreds?

I saw another objection to social media igniting before my eyes, so I decided to stomp out the flames before they got out of control.

I went back to Melissa and asked if they’d be interested in doing some more detailed analysis to show that the volume of drug mentions for any brand is quite manageable. They agreed and the result is this post. As I mentioned already, quite a few companies asked me after my “166″ post for the volume of discussions for their products. However, as this is how the folks at Nielsen make a living, we weren’t able to do with this. Instead, we decided to do a random selection of three companies from the top ten US pharma companies. The winners of this little lottery were Lilly, GSK, and Pfizer.

For each company, Nielsen looked at the top-selling products for this analysis. From their dataset of healthcare-specific websites, Nielsen BuzzMetrics collected, on average, more than 83,000 new discussions per day for the first half of 2009. Within this, there are a number of discussions about theses top-selling products. So, without further fanfare, here’s a look at the average number of discussions per day for the top five brands from each of the selected companies:

[Click on the image for a larger view]

Average Brand Buzz Per Day for Select Top Pharma Brands

Across these 15 brands, there are an average of 45.4 online discussions per day incorporating a brand mention. The volume of discussion can vary widely by brand. One interesting revelation: top sellers are not necessarily the most-buzzed brands. Lipitor and Advair, for example, are the two best-selling drugs among the 15 brands in the US (in dollar sales) and yet fall squarely in the middle of the pack for mentions. The top-mentioned product was Lyrica, which came in at number 8 of 15 in product sales.

Of course, there are many factors that can affect conversation volume, including disease state. It is interesting to see that some of the products you might expect to have a lot of volume based on their “controversial” nature don’t rise to the top. Cialis and Celebrex immediately come to mind. For the former, you might expect more off-color discussions cropping up, which would drive volume, but keep in mind, Nielsen only reviewed healthcare-specific sites for this analysis (so, any mention of Cialis on, say, PerezHilton.com, isn’t going to show up). In addition, mentions that included obvious spam terms such as “buy online” were excluded. For Celebrex, you might expect more volume based on the product’s past controversies. This doesn’t appear to be the case. However, volume can also change suddenly – when there is news about a brand (bad or good), a new market entrant, a public event related to the condition (Breast Cancer Awareness Month), etc.

So, that’s the raw data, the question now becomes: If a pharmaceutical brand wanted to monitor all of this discussion for things like adverse events, claim expansion, misinformation – or even just to understand what consumers are saying about the brand – can it be done in a practical manner?

To start, some filtering can be used to automate part of the process. For example, messages can be filtered for mentions of brand keywords. That’s what was done for this analysis. Nielsen filtered the more than 83,000 messages and pulled out only those messages that contained one of the 15 products selected for this analysis. It’s a very simple filter that every basic screening and monitoring tool can handle. The rationale for filtering out discussions that don’t contain a mention of a brand is that with this, you can’t have a reportable adverse event.

The next step is then sifting through all the mentions of your brand. The chart below shows how many discussions per day, on average, each brand would have to manage. For Cialis, about 17 discussions would have to be screened each day. For Lyrica, on the other hand, 132 discussions per day would have to be screened.

When you apply the “1 in 500″ statistic to these numbers, you get a better sense of how often a reportable adverse event is likely to show up.

[Click the image to enlarge]

Number of Days of Mentions to Find One Adverse Event

Translation: It takes a long time before a discussion with a reportable adverse event pops up. For example, it would take almost a month’s (29.6 days) worth of discussions to find one Geodon reportable adverse event. At the same time, you might expect to find one for Cymbalta every 5 days or so. Two things come to mind: first, that’s a lot of discussions to review without finding anything. Second, rather than being a deluge of  reportable adverse events, most brands aren’t even talked about that much making it much less likely that there are reportable AEs out there that you’re missing.

Since you might have to go through quite a few discussions to find one that requires your attention, let’s see at what the screening process might look like. First, the time required will vary greatly. Some discussions can almost instantly be determined not to have a reportable AE, while others are going to require some more time and attention.

Taking a look at some of the discussions seen for Lyrica (the most mentioned of the brands reviewed), you can basically group the discussions into one of three categories: those you could skim past relatively quickly (as they lack even the most basic information), those that might give pause for thought but could probably be filed away or handled with pre-approved response language (if you were doing actual outreach and engagement), and those that may require escalation depending on the company’s social media and customer response policies (these are the Discussions with potential reportable adverse events).

Here’s one of each from Lyrica [note: quotes are unedited]:

Skim past quickly: “i am doing much better thanks hun…i have neuropathy and use lyrica as well as ativan it does help me / lyrica helps with fibro….my very best to you and hubby…happy holidays sweetie” – from healingwell.com

Requires some thinking: “Aren’t they basically the same drug? Lyrica is just FAR more powerful than Neurontin? My Neuro explained Lyrica is 8x more powerful than Neurontin and if he up’s the Neruontin and makes an equiv. does it will be about the same response?” – from neurotalk.psychcentral.com

Might require escalation: “I am on my second try with Lyrica. I am on 75mg twice a day. I had dizzyness and blurred vision both times. The dizzyness has subsided, but the blurry vision is still there. I am on my 3rd week and so far I haven’t noticed any pain relief. Using it in combination with Nortriptylene and Lorcet for nerve pain in my ribs.” – from healingwell.com

So, the screening and coding for the 132 Lyrica discussions might only take a few minutes or could take an entire day and several people’s efforts if they are sufficiently complex. It all depends on how many of each category you have.

Beyond simply filtering for brand names, it’s possible to automate the process by looking for keywords related to known side effects, and/or keywords related to negative perception. However, this step brings up two key challenges. First is that any unknown side effects (which are the ones a brand might be most interested in discovering through this process) are the true “needles in the haystack” since they will likely not be covered by established keywords. That is, you’re not likely to find the unexpected and serious events that can really impact public health if only look for known side effects. Second is the challenge of using natural-language processing to accurately detect sentiment around healthcare messages. The nuances and unique considerations within healthcare discussion make it very tough to train a computer to digest what patients and caregivers care most about. Many monitoring companies, including Nielsen BuzzMetrics, use keywords to identify messages about a brand, and then use manual analysis to read and code messages for sentiment and topics of discussion. Manual analysis means that someone has to go through all the messages by hand at some point and determine what’s important and what’s not.

A pharmaceutical company could consider doing analysis process internally. Social media messages could be automatically screened for mentions of particular brand names, and then sent to a team within the company for review and follow-up action, if warranted. Within BuzzMetrics, they typically find that an analyst can read and code about 100 messages per day. That doesn’t include any internal routing or follow-up communications with original posters that a pharma company might want its employees to do, which would take additional time. An ideal group to handle this at pharma companies are those people already staffing your call center and who deal with adverse event reports received via phone (and other product inquiries). While they aren’t on a call or otherwise have a lull in the action, each person can review a handful of messages and determine if any need action. If they do find one, then the information is already in the hands of the right people at the company. Call center reps are trained on which issues they can handle directly and which need to be escalated. They understand the chain of command. They have established scripts to use over the phone, and some of this language (or key themes from it) can translate to the online world. And, of key importance, they know how to interact one-to-one with customers – which is really what social media is all about.

Let’s also keep one thing in mind. This volume of mentions is basically for all the social media discussions on all the health-related sites on the Internet (English-speaking only). These sites range from massive (like WebMD) to personal blogs with small followings. So, if you choose to monitor everything out there, this data shows what you can expect. However, under the current regulations, you are not required nor obligated to monitor third-party sites unless you are somehow connected with the site (as a sponsor, etc.). This means that you are only required to manage the sites that you maintain, own, or otherwise control in some way. This includes assets like your brand websites, any blogs, YouTube channels, Twitter (if someone DMs or replies directly to you), Facebook pages, and unbranded disease information and community sites. If you already have any of these, you know that you aren’t going to get a huge volume of discussions whether they be blog comments or YouTube comments. Most of the pharma social media programs that I’ve seen have received only a handful of comments over their entire lifetime. Even the most ambitious and well-known properties such as J&J’s BTW blog (the best healthcare industry blog IMO) don’t get very many comments. Their last 10 posts have 13 comments combined (and 6 of these came from Marc Monseau‘s post “What’s the ROI?”). That’s 13 comments since October 27…not a lot to monitor. Of course, J&J might have gotten more comments than this and a few were removed in moderation, but based on what I know of this blog very, very few comments are not published.

The next question is: “why?” Why are you screening and scanning the entire Internet looking for adverse events? The answer might be simple. Perhaps you want to know what people are saying about your brand to help direct future communications. Maybe you’re actually going to talk back and not just listen in. You might also want to listen everywhere because of a genuine desire (whether legally required or not) to know everything you can about the safety of your product. You might be looking just to check for unexpected adverse events. Isn’t it better to find out early about a serious adverse event that keeps occurring and, yet, wasn’t seen in clinical trials? The longer you wait, the more lawsuits get lined up. Of course, more important than the legal issues, the longer you wait or the longer it takes to discover a new, serious adverse event, the more people who could be harmed or killed by the product.

Perhaps the other answer to “why?” might simply be to provide better service to customers by better understanding them. Not just to know about harmful effects, but to know about questions, misinformation, patient concerns about the medication, or about disease treatment in general. You can see from this and many other analyses that there isn’t a high volume of AEs in online conversation, so if we move past that, maybe better serving patients should be the ultimate goal of monitoring online discussions.

We’ve found that most companies actually do want to monitor everything that’s out there (before you do, read my post Why Pharma Should Forget About Social Media Monitoring), but they either lack a purpose behind their monitoring or they’re concerned about what they’ll find. The latter concern includes worrying about how to manage the volume of messages that are out there. However, this analysis shows that the volume isn’t unmanageable even for the biggest pharma brands and perhaps eliminates one more barrier to pharma and healthcare companies first observing and then participating in the discussions happening all around them.

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?