The Myth of Adverse Event Reporting

Mini White Paper

I’ve written a fair amount about the use of social media in healthcare (here and here), particularly pharma, on this blog. And, like many other people working to try to enhance healthcare marketing by including channels such as social media, I’ve heard all the same excuses. I was reading John Mack’s post today at Pharma Marketing Blog and it inspired me to write a quick little summary about what I call “The Myth of Adverse Event Reporting.”

Before getting to that, a little setup. Let’s be clear, the reality is that many healthcare companies (or many other industries for that matter) aren’t ready to incorporate social media into the mix. The specific reasons are different for each industry, but they share some commonalities. Here are the big reasons:

  1. Afraid to give up control of the brand
  2. It doesn’t work/impossible to measure
  3. No one in my target audience uses social media
  4. Worried about bad reviews

For pharma, these same reasons persist, but they have a little different spin:

  1. Same
  2. I can’t track it like physician-level prescription data
  3. Older people use my products and they don’t use social media
  4. Adverse Event reporting 

So, let’s take a look at each of these one at a time. I’ll save the one that kills me the most, Adverse Event Reporting, for last.

1. Afraid to give up control of the brand

Surprise, you already lost control of your brand. Conversations are going on without you already. Don’t believe me? Pull up any discussion board on WebMD. It’s going on without you. Search for your company’s products and see what people are saying. They’re saying it’s great, it’s horrible, it gives me gas, it makes my teeth whiter, it made Aunt Sally turn blue. They’re also giving and receiving medical advice that only a physician should give. So, if you think that allowing people to comment or post information about your product might take control from you, you’re right. However, do you want it happening on WebMD where you have no control and can’t really respond effectively or do you want it happening on your site where you can?

2. It doesn’t work/impossible to measure (for pharma: I can’t track it like physician-level prescription data)

First, social media is no harder to track or correlate with sales than any other online program done in healthcare (or offline for that matter). It is far more difficult in pharma to track the effects of a specific promotion on sales compared to other industries. In consumer packaged goods (CPG), for example, you can do panel match studies where you know who is doing what, what messages they are exposed to, and if it had a specific lift in sales. Our company does this all the time. In pharma, you don’t have this level data and you never will. HIPPA prevents it. So, get used to that. You can’t determine if someone who saw your commercial actually went and got a prescription and filled it. You can ask them, but that’s not reliable. The fact is, you may need to use other measures to determine if the program is effective. You do many programs where the efficacy is measured in clicks or visitors (rightly or wrongly) and you can do the same in social media. In addition,  in social media, you can actually track real-time brand sentiment. Instead of being a tactic to completely change opinions, you can actually use it as the proverbial “canary in a coal mine” to see if your other activities and messages are having an impact on opinion. For example, if you put out a new TV ad (please don’t by the way), you can rest assured that someone is commenting on it right now online. What does that conversation look like?

3. No one in my target audience uses social media (for pharma: Older people use my products and they don’t use social media) 

This simply isn’t the case anymore. You should know this by now. No? Well, here’s the info one more time. Consider just one social networking site for a minute. Facebook. Its share of college age users continues to decline every month. In addition, in the US, there are over 4 million users over the age of 35.

Isn’t 4 million a lot? Sure, it’s not number of people watching American Idol each week, but it’s not a small number. That’s just Facebook. Rest assured that the number of “older” people using social media will only increase in the future.

4. Worried about bad reviews (for pharma: Adverse Event reporting)

So, this is the main reason for today’s post, but since you came all this way, I figured I’d give you a few other things first. No charge. Let’s address bad reviews first. Product reviews are the norm now in ecommerce, but they weren’t always. One of the big reasons is that companies were afraid of negative reviews. It turns out, of course, that simply having reviews can increase traffic, conversion rate, and average order value (see more detail here). In addition, negative reviews aren’t an issue so long as there aren’t only negative reviews.  Consider yourself for a minute. You’re checking out a product online and all the reviews are glowing. What do you think about that? You’d probably feel like the results might not be all that authentic. Instead, when there are negative reviews, it actually can lend credibility to the product (and site) because people know the reviews are actually genuine. Negative reviews don’t turn people off. They read them and consider whether the negative would actually bother them. For example, someone ranks a product 1-star and says “this didn’t work on my Mac.” Well, if you have a PC, you aren’t worried. Simple example, but you see how it works.

Adverse Events are nothing more than negative reviews. If you want people to genuinely talk about your brand, they are going to say negative things. But how often do posts include adverse events? Nielsen decided to take a look at this rather than simply assume it was ” a lot,” which of course is a difficult number to manage. Nielsen looked at Yahoo Health boards and took 500 postings. Of these, only 1 contained enough information to qualify as an adverse event that needed to be reported. That’s 0.2%. Why so low? Turns out that someone simply saying that your drug caused them to have a headache isn’t enough to qualify as an adverse event. Nielsen summed up the pieces of information required to report an adverse event and there are four pieces: “(i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome.” (Hat tip to Pharma 2.0 for the summary). The study showed that one or two of these pieces were often available, but not all four. In addition, they found that it would be impossible to get all four even with some effort. In fact, the FDA says, “[Without these 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.”

This is because people often don’t register or leave their personal information in a post, so there is no way for a company to follow up and fill in the blanks. Naturally, if there is something significant, every effort should be made, but on the often anonymous Internet, this is usually difficult. Suppose for a moment there were several adverse events that need to be reported. How often do they need to be reported? The FDA is pretty clear on this. For new drugs, reports need to be filed quarterly for three years. After that, it’s annually. For “serious and unexpected” events, these have to be reported within 15 days. However, there’s a pretty high threshold for an adverse event to be considered “serious and unexpected.” Every company already has these reporting channels in place, so it is simply a matter of including adverse events received from social media into the workstream. 

 

Yes, it’s a balance. The fact is adverse events should not be the reason why healthcare shies away from social media. These risks can easily be mitigated and, if done right, can actually be used in a positive way. So, don’t use adverse events as an excuse anymore. You’ve got the data. 1 in 500 posts include a reportable event. You report quarterly at most (which you’re doing anyway). How much ongoing effort do your other marketing programs require? Probably quite a bit more than this. Next time you hear this excuse, you’ve got the data to dispel the myth of adverse event reporting.

Tags: , , ,

19 Responses to “The Myth of Adverse Event Reporting”

  1. Scott January 22, 2009 at 3:55 pm #

    Wow – great post. Excellent metrics in your adverse events section. This will certainly prove useful in some upcoming client conversations. Thank you.

    Scott’s last blog post..Social Media – Filling The Void

  2. Scott January 22, 2009 at 10:55 am #

    Wow – great post. Excellent metrics in your adverse events section. This will certainly prove useful in some upcoming client conversations. Thank you.

    Scott’s last blog post..Social Media – Filling The Void

  3. Jonathan Richman January 22, 2009 at 4:04 pm #

    Thanks, Scott. I hope it’ll be useful. Please report back on what response you get. I’d imagine it’ll be a bit of disbelief. I’d bring the Nielsen article for backup.

  4. Jonathan Richman January 22, 2009 at 11:04 am #

    Thanks, Scott. I hope it’ll be useful. Please report back on what response you get. I’d imagine it’ll be a bit of disbelief. I’d bring the Nielsen article for backup.

  5. chris cullmann February 1, 2009 at 4:43 pm #

    Great metrics. In December, Ben Lorica at O’Reilly posted an article about the adoption rate of facebook: http://radar.oreilly.com/2008/12/facebook-growth-regions-and-ge.html . There is a clear trend that a more mature audience is adopting facebook.

    Additionally, what is rarely mentioned when reviewing social media applications in reference to the healthcare industry is the new generation of doctors who are entering the field. These new professionals are not likely going to abandon mediums that they had comfortably used through their education.

  6. chris cullmann February 1, 2009 at 11:43 am #

    Great metrics. In December, Ben Lorica at O’Reilly posted an article about the adoption rate of facebook: http://radar.oreilly.com/2008/12/facebook-growth-regions-and-ge.html . There is a clear trend that a more mature audience is adopting facebook.

    Additionally, what is rarely mentioned when reviewing social media applications in reference to the healthcare industry is the new generation of doctors who are entering the field. These new professionals are not likely going to abandon mediums that they had comfortably used through their education.

  7. Jonathan Richman February 2, 2009 at 3:21 pm #

    Chris,

    Great point about the next generation of doctors. Companies are going to have to get comfortable talking to them in the ways they are used to. Social media certainly would be top of the list for many of them. Hadn’t thought of it that way. Thanks for adding.

  8. Jonathan Richman February 2, 2009 at 10:21 am #

    Chris,

    Great point about the next generation of doctors. Companies are going to have to get comfortable talking to them in the ways they are used to. Social media certainly would be top of the list for many of them. Hadn’t thought of it that way. Thanks for adding.

  9. Alasdair Munn February 2, 2009 at 4:04 pm #

    Great post Jonathan. It is amazing that the phrama industry needs to be pitched at this level, but you have hit the right tone and messaging for this audience.

    With regard to point number three regarding older users, they are not only getting more Internet and Social Media savvy but in some cases their meds decisions are taken or indeed influenced by their children or carers, who are, as your figures show, users of social media.

    I look forward to more of your thinking.

  10. Alasdair Munn February 2, 2009 at 11:04 am #

    Great post Jonathan. It is amazing that the phrama industry needs to be pitched at this level, but you have hit the right tone and messaging for this audience.

    With regard to point number three regarding older users, they are not only getting more Internet and Social Media savvy but in some cases their meds decisions are taken or indeed influenced by their children or carers, who are, as your figures show, users of social media.

    I look forward to more of your thinking.

  11. Jonathan Richman February 2, 2009 at 8:55 pm #

    Alasdair,

    Great observation about the caregivers (carers). Hadn’t thought of that angle. A number of pharma companies, especially for particular drug classes, concentrate a great deal on caregivers, but they try to reach them in traditional ways. These ways might work for the people they are caring for (e.g., their parents), but not for them.

    I think this is a whole new post. Thanks.

  12. Jonathan Richman February 2, 2009 at 3:55 pm #

    Alasdair,

    Great observation about the caregivers (carers). Hadn’t thought of that angle. A number of pharma companies, especially for particular drug classes, concentrate a great deal on caregivers, but they try to reach them in traditional ways. These ways might work for the people they are caring for (e.g., their parents), but not for them.

    I think this is a whole new post. Thanks.

  13. Arthur Alston February 25, 2009 at 3:59 am #

    Hi Jonathan

    I read this article a while ago and like the commentators above, think its another very good posting from you.

    I reread it today because I am meeting with some senior marketeers next week to talk with them about a social marketing project I want to embark on. I will be using the following (age old) approach in the talk: current reality, future reality and how do we bridge the gap (of course my solution is to bridge the gap with a social media project – but you already knew that.)

    I will be using the four points you made above as the current reality.

    Good job. This blog is developing in to a very useful resource. Keep it up.

    Arthur Alston’s last blog post..Elegant example of technology making something complex very simple

  14. Arthur Alston February 24, 2009 at 10:59 pm #

    Hi Jonathan

    I read this article a while ago and like the commentators above, think its another very good posting from you.

    I reread it today because I am meeting with some senior marketeers next week to talk with them about a social marketing project I want to embark on. I will be using the following (age old) approach in the talk: current reality, future reality and how do we bridge the gap (of course my solution is to bridge the gap with a social media project – but you already knew that.)

    I will be using the four points you made above as the current reality.

    Good job. This blog is developing in to a very useful resource. Keep it up.

    Arthur Alston’s last blog post..Elegant example of technology making something complex very simple

  15. cheryl June 2, 2009 at 3:47 pm #

    I truly enjoy your posts, although I work in a slightly different area, an agency for clinical trial patient recruitment. What do you think is the application for using social media to support clinical trials considering:

    1) EVERYTHING the public sees about a specific study must go through an independent review board for review/approval, including a response to a comment (it usually takes a few days for approval).
    2) Enrollment for clinical trials varies considerably, but generally around 6-12 months (so we don’t have a long term opportunity)
    3) Very few people participate let alone understand the clinical trial process http://www.ciscrp.org/information/facts.asp. This can lead to lots of negativity and misinformation…but to respond will take IRB review (delays)

    There are other variables, but wanted to get your thoughts.

    I hope you’re ok with me commenting/inquiring here. Thanks!

    • Jonathan Richman June 4, 2009 at 3:19 pm #

      Great questions, Cheryl. Why I think there’s a place for social media in recruitment, as I see it, is because there are so many condition specific communities out there with very active members who are constantly looking for the newest, latest thing (check out some communities here: http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/). Essentially, you have your entire targeted patient population in one place. So, versus, say, a TV or print ad about your trial, you know that everyone who sees your “ad” on the social networking site is your target. The question is how you “advertise” on these sites. I think you have to become a valuable and trusted part of the community first and then put out information about your trial. If people find it to be quality information and an important study, you can count on them to share it even further.

  16. cheryl June 2, 2009 at 11:47 am #

    I truly enjoy your posts, although I work in a slightly different area, an agency for clinical trial patient recruitment. What do you think is the application for using social media to support clinical trials considering:

    1) EVERYTHING the public sees about a specific study must go through an independent review board for review/approval, including a response to a comment (it usually takes a few days for approval).
    2) Enrollment for clinical trials varies considerably, but generally around 6-12 months (so we don’t have a long term opportunity)
    3) Very few people participate let alone understand the clinical trial process http://www.ciscrp.org/information/facts.asp. This can lead to lots of negativity and misinformation…but to respond will take IRB review (delays)

    There are other variables, but wanted to get your thoughts.

    I hope you’re ok with me commenting/inquiring here. Thanks!

    • Jonathan Richman June 4, 2009 at 11:19 am #

      Great questions, Cheryl. Why I think there’s a place for social media in recruitment, as I see it, is because there are so many condition specific communities out there with very active members who are constantly looking for the newest, latest thing (check out some communities here: http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/). Essentially, you have your entire targeted patient population in one place. So, versus, say, a TV or print ad about your trial, you know that everyone who sees your “ad” on the social networking site is your target. The question is how you “advertise” on these sites. I think you have to become a valuable and trusted part of the community first and then put out information about your trial. If people find it to be quality information and an important study, you can count on them to share it even further.

  17. Richard December 13, 2010 at 1:30 pm #

    Point 2 always baffled me. It’s easier to track anything online than it is offline because everything you do online is logged in one form or another. Once you are aware of the tools available, everything down to the last tweet or Facebook message can be back-tracked.

    Phone calls are more open to interpretation than any of the forms of social media that need to be monitored.

    The biggest myth that needs dispelling is how many believe that social media should work by just spending a few minutes on Twitter and posting a few links, and then they dismiss it as not working.