Yes, I did attend the hearings and had the opportunity to speak twice; once on adverse event related issues and once on how pharma can engage in various social media platforms. [You can get copies of these presentations and my speaking notes here: http://www.doseofdigital.com/2009/11/sneak-preview-fda-social-media-hearing-testimony/]
There were 60+ other speakers as well with a majority representing agency service companies, but also a handful of pharma companies and a few groups representing the consumer. These ranged in quality and content from outstanding to confusing and frustrating, but I remain impressed that FDA was able to pull this off in a relatively short period of time.
Two themes emerged for me while I was there upon some reflection afterwards. While I didn’t go into the meeting with specific expectations, I was hoping to learn a few things and see some innovative thinking on how to tackle this problem. So, what came out for me was a handful of things that I learned at the meeting and hadn’t heard before and a bunch more that I had heard plenty of times before. There was a final category that I can now describe as those things that I wish I had learned. These are the few nagging questions that I still have even after the hearing and that I’m not completely confident will ever be answered.
So, first, what I learned. I’ll cover each of these in detail in a bit, but here are the main themes. There are a few more that I’ll write about at a later time, but these are the main ones.
Here’s what I didn’t learn...more on these in a moment...
First, let’s look at each of the things I did learn
First off, while we give the FDA a hard time for being conservative and complain that they don’t know anything about the latest technologies, let’s not forget that they’re using more social technology platforms than almost every pharma company. Sure, they have a few less regulations to deal with, but to think they don’t know anything about this area is naïve.
Despite this massiveness of this understatement, the FDA hits on the big social media platforms here. They don’t name them by name, but rather capability and this is smart. I’ll show you why in a bit.
Even the questions and sub-questions they asked in their announcement of this public hearing and that the speakers addressed, show that they know where they need to focus and where the ambiguity lies. [You can get the announcement and full list of questions from FDA here (note: PDF): http://edocket.access.gpo.gov/2009/pdf/E9-22618.pdf]
MedWatch was, of course, created to allow physicians and consumers a way to submit adverse experiences to the FDA so that they can be tracked and, presumably, evaluated for patterns or major deviations from what’s been shown in clinical trials. In the past, the vast majority of events were reported by physicians, but now consumers report the bulk of adverse events. However, very few are ever actually reported despite some new requirements and company policies that make the MedWatch information available on a number of differenet promotional efforts.
A number of presenters mentioned improving MedWatch especially as it relates to making it simpler to use. Here’s an example of a widget prototype created by Ignite Health [found here: http://www.ignitelabs.com/fdawidget/]. Basically, you can embed this widget in your brand.com site and allow people to report the event right from your site. This raises two questions for me. First, why should you care if people aren’t reporting adverse events? Well, of people aren’t using MedWatch, then no one is reporting AEs. This leaves the impetus back on pharma who has shown more than a little reluctance to monitor for AEs.
The second question deals with the motivation for reporting AEs. People don’t go online and search for their drug to figure out how to report an adverse event they’ve had with it, they search to see if what they have is normal and/or what to do about it. Reporting it is the last thing on their mind. It’s like seeing your hot water heater leaking water and running to call the company to complain. First thing you do is shut off the water or call a plumber (read: doctor).Consumers have no motivation. However, there are some sites that get people to share all sorts of information about their treatments including the good, the bad, and the ugly. One great example is Patients Like Me. The reason why people share their information is because they get something in return. They get to compare themselves with others and to see if what they have is “normal.” Why doesn’t MedWatch allow you to see what others have reported about the drug you’re taking and if what you have is “normal”? Why not just partner with companies like Patients Like Me and do a statistical sampling instead of dealing with the entire MedWatch system?
It turns out according to data presented by WEGO Health. WEGO Health, among other things, works with Health Activists, essentially the “power users” among online patients. They surveyed these patients to get their take on pharma’s involvement in social media and there’s some good news. [Read bullets] It turns out that patients actually want our participation when we do it the right way. [The WEGO Health data can be found here: http://www.healthcentral.com/about/wp-content/uploads/2009/10/WEGO-Health-FDA-Question-5_FINAL.pdf and http://www.slideshare.net/WEGO_Health/wego-health-fda-social-media-presentation-questions-13]
Here’s a case in point, they know that we can provide better advice than this and in many ways, they expect it. This is where the bad news comes in.
If pharma’s going to play in social media, they’ve got to call “all in” because that’s what patients are demanding. They’re happy to let pharma into the party, but we’d better bring some beer and be ready to clean up afterwards also.
In short...to whom much is given, much is expected.
Okay, so now onto what I didn’t hear at the meeting, but wish I had...
Number one, how is the FDA going to keep up with changing promotional platforms? Sure, and assuming they do it in a reasonable timeframe, we’ll have some guidelines for how to handle the social media platforms mentioned in the FDA’s questions. But how long are these questions relevant? This is picture is of what is widely recognized as the world’s first advertisement. I’ll carved into the street in Ephesus, Greece and dates to around the year 0. Is said to be an advertisement for a brothel with the footprint pointing the way. We’ve come a long way since then, but our advertising has changed quite a bit and the acceleration of the change has become greater and greater.
This is the world’s first banner ad from 15 years ago as it appeared on HotWired.com. Believe it or not, this is an ad for AT&T. I have no idea what it means, but there it is.
When the FDA met back in 1996 to discuss some Internet-related issues. Before last week, this was the first hearing related to Internet based promotion. Back then, there was social media...sort of. GeoCities was super popular with people making their own little “communities” and SixDegrees was launched with roughly the same concept as Facebook or MySpace, but it simply didn’t make sense to people. So, if we had a hearing back then, we might have some rules for promotion on SixDegrees, which wouldn’t do us much good today since the site folded in 2000.
Where MySpace was once the hottest property, it’s now Facebook, but Twitter is closing fast. Which one of these is going to be in my “remember when?” presentation thirteen years from now?
So, the reality is that if we wait 13 years between each meeting, the guidance is almost instantly obsolete and fraught with numerous issues.
Here’s the location of the next FDA technology-related hearing. We can all show up in our flying cars to talk about how we handle the “Semantic Web”...whatever that is. What is needed is some sort of ongoing committee to review the programs and platforms to make sure they don’t get out of date. This committee needs to include people from FDA, pharma industry, and a few choice industry service companies. This group will be able to highlight emerging technology issues and also make basic recommendations for addressing them.
By now, we’ve all seen this slide a hundred times, so I’m not going to explain it again. The gist is that most discussion group or blog posts don’t have all of the four elements required for an adverse event to be “reportable.” The rate is 1 in 500 or 0.2%.
I can also tell you from Nielsen BuzzMetrics, the same company that did the previous analysis, tracks more than 1350 sites, blogs, forums, and discussion groups. On average, there are about 83,000 new discussions per day. That’s quite a bit of volume. When you apply the 0.2% rate for reportable events, what you’re left with is 166 adverse events per day divided across the entire industry. Doesn’t that seem like a manageable number? I just wrote about this and to me, this should put to bed the entire AE reporting issues. [My post on this topic is here: http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-read-herring/]
Okay, great news, we can cross off the red herring that is adverse event reporting. What’s that you say? There are others? Just from casually talking with folks, these other areas of concern came to the surface. I wonder at what point will all of these concerns be answered. The reality is that they’re never likely to be answered, so companies will have to evaluate for themselves.
So, just when I thought that I’d made this guy extinct...here he is again...
This is my final one and really is the biggest question I have and one that I felt was totally unanswered. The question is simple. Given free reign, what is it that pharma, all of you that is, wants to do with social media? I didn’t like what I saw at the meeting. There were a number of suggestions about banner ads and how to account for fair balance (namely, how to have less of it). So, do you just want guidance so you and do more ads?
Google presented data that showed clickthrough rates on paid search ads plummeted after the FDA warning letters earlier in the year, as companies created more generic sounding ads that weren’t interesting or compelling enough for people to click on them. Google even proposed a new ad unit that includes an uneditable, direct link to more safety information. What you see here is a sponsored link for Yaz found during a search for “birth control” on Google. They’re already using the new ad unit, which includes the safety related “More info” link. Industry trade group PhRMA recommended the FDA add its logo to ads including paid search to increase public confidence that this is a legitimate information source. The biggest plank in PhRMA’s position and request to FDA dealt with paid search. Basically, looking for a way that the FDA can help increase the clickthrough rates of our ads. Google’s asking the same. News flash: FDA doesn’t care if people click on your pad search ads. To think they’ll sanction the use of their logo or something related that they’ll have to own is a bit of a stretch. So, was all this protest about no guidelines all about getting permission to do more with paid search ads?
Many people talked about simplifying safety information. This isn’t what the FDA asked. They asked about how pharma can use space constrained platforms (like Twitter’s 140 character limit) and still effectively communicate product risk information. Many took this as an opportunity to suggest places to cut out safety information or dramatically abridge what’s already there. Not that you want to remove all of the safety information, but you’d welcome the chance to reduce it substantially.
Maybe you want to edit Wikipedia, as many people mentioned. How do you do it in a compliant way? Is this the best use of the new platforms that are available to people? Wikipedia? Sure, this might be one part, but it received disproportional attention at the meeting. I don’t think the greater purpose of the hearing was to get buy-in on the appropriate way to use a specific platfom like Wikipedia. I hope we were asking for far more than this.
Maybe we want to send interruptive, branded tweets like this one. But can we effectively do it without guidelines? My question: can you effectively do it guidelines or otherwise?
The FDA asked these questions, but I can boil them down to just one question...just one thing the FDA must consider...
Does allowing additional leeway for pharma to participate in social media improve or harm public health? If the answer is the latter for any new, recommended piece of guidance, the answer will be unquestionably “no”. The question we must ask ourselves is: how are we going to use these channels in a manner that improves patient health FIRST and then promotes our products? I haven’t heard a good answer to this question and we need to do that before we do anything. If we don’t know the answer, the guidelines don’t mean anything.
FDA Social Media Review From Dose Of Digital
Three Things I Learned at the FDA Hearings and Three I Wish I Had Jonathan Richman Director of Strategic Planning, Bridge Worldwide Author, Dose of Digital @jonmrich
The FDA gets it <ul><li>“ Since the 1996 public meeting, there has been a massive expansion of new tools and technologies, such as blogs, microblogs, podcasts, social network sites (‘social networks’) and online communities, video sharing, widgets, and wikis...” </li></ul>
The FDA gets it <ul><li>For what online communications is pharma accountable? </li></ul><ul><li>How can pharma follow the rules in using tools with space limitations and real-time comms? </li></ul><ul><li>What rules apply to the posting of corrective info on websites controlled by third parties? </li></ul><ul><li>When is the use of links appropriate? </li></ul><ul><li>Questions specific to Internet adverse event reporting </li></ul>
Consumers might actually want us there <ul><li>AGREE that healthcare companies’ use of social media... </li></ul><ul><li>...provides important updates on products and services – 79% </li></ul><ul><li>...brings accurate information into conversations about drugs or devices – 73% </li></ul><ul><li>...addresses frequently asked questions about products and services – 66% </li></ul><ul><li>...adds valuable professional expertise to the conversation – 62% </li></ul>Good News
Consumers might actually want us there If I double the dose, would the blisters go away faster? Double your dose and see what happens, but I wouldn’t hold my breath.
Consumers might actually want us there <ul><li>AGREE healthcare companies... </li></ul><ul><li>...should monitor and correct misperceptions or misinformation when that info can be harmful – 90% </li></ul><ul><li>...should be responsible for policing any unauthorized versions of their content – 64% </li></ul>Bad News
Consumers might actually want us there <ul><li>In short... </li></ul><ul><li>To whom much is given, much is expected. </li></ul>
What I didn’t <ul><li>FDA’s plan for keeping up </li></ul><ul><li>The end of the red herrings </li></ul><ul><li>What pharma REALLY wants to do </li></ul>
FDA’s plan for keeping up 1996 2022 2009 FDA Technology-Related Hearings Schedule
FDA’s plan for keeping up 1996 2022 2009 FDA Technology-Related Hearings Schedule
The end of red herrings Only 1 in 500 posts qualifies as a “reportable adverse event”
The end of red herrings Source: Nielsen BuzzMetrics, Personal Communications Nielsen BuzzMetrics total Healthcare discussions (~1,350 sites): 82,697 per day Percentage of posts with a reportable adverse event: 0.2% Number of reportable adverse events for the ENTIRE INDUSTRY : 166 per day
The end of red herrings <ul><li>Adverse event reporting </li></ul><ul><li>Off label discussions </li></ul><ul><li>Personal identifying information </li></ul><ul><li>Monitoring volume and resources </li></ul><ul><li>FTC regulations </li></ul><ul><li>Technology integration </li></ul><ul><li>No clear precedents </li></ul><ul><li>Lack of internal expertise </li></ul>
What pharma really wants to do <ul><li>For what online communications is pharma accountable? </li></ul><ul><li>How can pharma follow the rules in using tools with space limitations and real-time comms? </li></ul><ul><li>What rules apply to the posting of corrective info on websites controlled by third parties? </li></ul><ul><li>When is the use of links appropriate? </li></ul><ul><li>Questions specific to Internet adverse event reporting </li></ul>
What pharma really wants to do <ul><li>Does allowing additional leeway for pharma to participate in social media improve or harm public health? </li></ul>
Three Things I Learned at the FDA Hearings and Three I Wish I Had
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