Social Media Wiki

FDA Public Hearing on Social Media Agenda and Speaker List Released

As most of you know, in a couple of weeks (November 12-13), the FDA is holding a public hearing on the use of social media by pharma and medical device companies (and others). Officially, the title of the hearing is: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (Document ID FDA-2009-N-0441-0001).

Catchy, right?

In any event, since this is a public hearing, people were allowed to request both a seat to attend the meeting and also to speak at the meeting. If you haven’t already applied for a spot, forget it, as the deadline has passed and all the seats are gone. Apparently, there were more than 800 requests for the 300 or so seats (John Mack has a nice recap of all this). We also knew that around 60 people would be speaking over the two days.

The meeting has been broken up into two parts. November 12 and the afternoon of November 13 will tackle the first four questions in the FDA’s announcement. The fifth question in the announcement deals with the handling of adverse events (AEs), which even the FDA recognizes as the major stumbling block for companies in dealing with social media. The morning of November 13 will deal exclusively with the AE question, so there is a great deal of attention being paid to it. Those requesting to speak (or who were invited) could request to speak on any of the questions. Those who wanted to cover question five and another question (and who were accepted as speakers) were given two speaking spots.

The speaking times have been limited to between 5-15 minutes, but it appears that most are around 10 minutes. How do I know all of this? I have the privilege of being one of the speakers and I will be one of the people who covers question five and another (question 3), so you’ll get to hear me twice. For those who can’t attend, the FDA has set up a webcast to watch it live.

So, you probably want to know who’s speaking. Here’s the list with a link at the end to download a PDF copy of the draft agenda. This agenda is subject to change (according to FDA) based on speaker confirmation and availability, but this is this first release of names and tentative times. I’ve removed the times from my list below, but they are included in the PDF at the end of the list. You’ll see a company name and then a person(s) representing the company here. Again, some names you’ll see twice because they are speaking twice and covering different issues.

November 12

Pew Prescription Project/The Pew Charitable Trusts-Alan Coukell

Coalition for Healthcare Communication-John Kamp

Eli Lilly and Company-Michele Sharp

AdvaMed Advertising and Promotion Working Group-Tony Blank

Center for Medicine in the Public Interest-Peter J. Pitts

Ogilvy 360 Digital Influence-Rohit Bhargava

PhRMA-Jeffrey K. Francer

Pharma Marketing News-John Mack

The Advertising Coalition-James H. Davidson

Arnold I. Friede & Associates-Arnold I. Friede

Integrated Media Solutions/The Sandino Group/Caleco Pharma Corp-James A. Sandino

Interactive Advertising Bureau-David G. Adams

National Research Center for Women & Families-Diana Zuckerman

VuMedi, Inc.-Robert Winder

WebMD-Wayne Gattinella

WEGO Health-Jack Barrette, Bob Brooks, and Marie Connelly

Consensus Interactive

Global Prairie Integrated Marketing-Alex Vandevere

sanofi-aventis-Craig M. Audet

Social Media Working Group-Mark Gaydos

Yahoo!-David Zinman

Waterfront Media Inc.-Ben Wolin

Johnson & Johnson Family of Companies-Philomena McArthur and Elizabeth Forminard

Manhattan Research-Mark Bard

Acsys Interactive-Stan Valencis

comScore-John Mangano

Envision Solutions, LLC-Fard Johnmar

MISI Company-Kathleen Fourte, Alejandra Diaz, and Jerilyn MacLaren-Hall

Compass Healthcare Communications-Peter Nalen and Maureen Miller

Euro RSCG Life 4D-Lawrence Mickelberg

McCann Healthcare Worldwide-W. John Reeves

Google-Mary Ann Belliveau and Amy Cowan

November 13

(morning session on AEs)

AdvaMed Advertising and Promotion Working Group-Tony Blank

Individual Consumer-Kim Witczak

Consumers Union-Steven Findlay

LehmanMillet-David A. Saggio

HealthCentral-Christopher M. Schroeder

Semantelli Corporation-Shaleen Gupta

PhRMA-Jeffrey K. Francer

Ogilvy 360 Digital Influence-Rohit Bhargava

The Advertising Coalition-James H. Davidson

Arnold I. Friede & Associates-Arnold I. Friede

GolinHarris-Rick Wion

Heartbeat Digital-Bill Drummy and MK Tantum

National Research Center for Women & Families-Diana Zuckerman

PatientsLikeMe-James Allen Heywood

Pharma Marketing News-John Mack

Sermo-Daniel Palestrant

TGaS Advisors-Donna Wray

VeoMed-Aaron Krinsky and Kay Metis

v-Fluence Interactive-Jay Byrne

WCI Consulting Ltd.-Tara M. Churik

WEGO Health-Jack Barrette, Bob Brooks, and Marie Connelly

Word of Mouth Marketing Association-John Bell and Melissa Davies

Bridge Worldwide/Dose of Digital-Jonathan Richman

Accelerated Medical Ventures-Zen Chu

(afternoon session, non-AE related questions)

Individual Consumer-Kim Witczak

Consumers Union-Steven Findlay

PatientsLikeMe-James Allen Heywood

Bulletin News/Custom Briefings-Paul Roellig

ORC Guideline, Inc.-Morris Whitcup

HealthCentral-Christopher M. Schroeder

LehmanMillet-David A. Saggio

Heartbeat Digital-Bill Drummy and MK Tantum

Semantelli Corporation-Shaleen Gupta

Sermo-Daniel Palestrant

TGaS Advisors-Donna Wray

VeoMed-Aaron Krinsky and Kay Metis

Bridge Worldwide/Dose of Digital-Jonathan Richman

Ignite Health-Fabio Gratton

imc2 health and wellness-Hensley Evans

RAPP-Robert Grammatica

Rosetta-Jamie Peck

W2 Group, Inc.-Larry Weber

Word of Mouth Marketing Association-John Bell and Melissa Davies

Digitas Health-Bruce Grant

Cadient Group-Jim Walker

Intouch Solutions-Wendy Blackburn

Pfizer-Freda C. Lewis-Hall and Clifford Thumma

Here is the PDF with the times: Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools Draft Agenda (1327 downloads)

Remember, you can still submit your comments until February, so do it if you’ve got something to say. I’ll be sharing my slides for the meeting sometime next week (you get a sneak preview). Of course, I’ll be tweeting like crazy from the meeting and will do a full recap afterwards, but do tune into the webcast if you can.

Pharma Marketing with Meaning Pecha Kucha

A few months ago, I innocently agreed to speak at the E-Patient Connections 2009 Conference. I say “innocently” because I didn’t know what I was getting into. It turns out that I somehow agreed to do a Pecha Kucha presentation. How hard could that be? Well, it was one of the most difficult presentations I’ve ever had to prepare. This is despite the fact that a Pecha Kucha presentation is only 6 minutes and 40 seconds. Minor detail though, you get only 20 slides and each slide is on screen for 20 seconds. After that, it advances automatically. No mercy. You don’t get to control it. If you want to see more about this format and see some great examples, check out the website dedicated to Pecha Kucha.

My topic was Marketing with Meaning as it applies to pharma, which I’ve talked about here before in a three part post ( 1, 2, 3). After much preparation, I felt I was finally ready. I was the last to go and, because it would have been too easy otherwise, there was a major glitch with my slides. Instead of seeing the slides I supplied them and checked the day before, I saw “slightly” edited slides that had all the titles cut off or otherwise misformatted. Sometimes this resulted in nonsensical statements and, at other times,  the results were quite amusing. Either way, I had to improv my way through not just this difficult format, but also the additional challenge of a little mystery every time a new slide appeared.

If you want a copy of the ACTUAL slides, as they were supposed to appear, you can download them here. You’ll see the titles and, therefore, slides make a lot more sense this way. This also includes my speaker notes as well..

Pharma Marketing with Meaning Pecha Kucha (914 downloads)


Without further adieu, here’s my presentation:

In the end, it worked out fine and I was told my presentation was even better because I had to fight through the slide format issue. Of course, I think I should be insulted by this because no one saw my presentation the “right” way so they couldn’t actually make this comparison. But, hey, I’ll take it.

You can dig through the Twitter hashtag feed for the conference to see everything discussed and you can find the feedback that I received as well (I’m afraid to look). The hashtag was #epatcon and I’m @jonmrich.

Here are a few photos from my talk as well. (Photo credit to E-Patient Connections/Kru Research)

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Here’s the presentation on SlideShare. Click through to see the notes for each slide.

How Pharma Overcomplicates Social Media

I just finished a few days at Digital Pharma this week and it was a great conference. One of the trailblazers in pharma social media, Shwen Gwee, was the chair for the conference and, as an advisor, I got to watch him push for the best of the best content and format. It worked. If you want a great recap of what happened, head off to Twitter and pour through the stream for the conference’s hashtag, #digpharm.

I had seen and heard a lot of what was discussed at this meeting before simply because I get to spend a lot of my time thinking about it. For others that have a different focus in their day-to-day jobs, I’m sure they took away even more than I did. For me, the best part of the conference was the informal, “unconference” discussion that took place for the last two hours of the final day and was lead by Brad Pendergraph from Novartis. There was no stage, no slides, no official speakers, just a bunch of people really interested in digital pharma marketing talking to each other. It’s perhaps not surprising that the conversation almost exclusively focused on social media, as it seems like THE thing to talk about right now (and has for a while). The upcoming FDA hearings on this topic naturally make it more relevant and top of mind (PS: I’ve been invited to speak at the hearing and can’t wait to get in my two cents).

The participants of this final discussion were a good mix of pharma employees and agency/consultant types like me. I mostly listened to the conversation and took a few notes. At some point, I heard one of those simple statements that suddenly helps it all make sense. The “ah-ha” moment.

With constant debate of can we?/can’t we? in pharma companies when it comes to social media, I’ve been saying for a long time that we’re making it too complicated. While there are a lot of objections and concerns within pharma companies when it comes to social media, the one I hear most often and that really bugs me is about the internal regulatory/legal process. There are a lot of other objections that come up, but this one seems to particularly bother me. Here’s what I’m talking about. Let’s say your company starts a corporate blog and (imagine this) allows people to comment. Sure, moderate the comments if you’d like. No problem, just let through the legitimate ones.

Now, here’s where I get frustrated. Let’s say one of the comments is something of a question…something like this: “Great point, but don’t you think that [insert whatever ending you want]?” Clearly, it’s something that the person would like an answer to. They want to engage with you and have a discussion. It’s a great opportunity, right? You know that, so you decide to respond…and that’s when the wheels come off.

Since you’re going to create a response to publish, you have to send it through your review process. It takes a solid two weeks to do that using your normal channels. Or, maybe you’re lucky, you have an expedited process for this type of thing and you can get something out in a couple of days. Of course, by this time, the commenter probably has forgotten all about you. You likely missed a chance to make a major, positive impression. But why? Why did your response have to go through your whole process? “Well,” you say, “you know the answer to that Jonathan. If we post something online, then it has to through our regulatory process. Same rules as if we created a printed piece. What’s wrong with you…have you forgotten everything you learned working at a pharma company?” Okay, so maybe you’d leave out the last part, but you’d say the first part pretty much exactly as I wrote it.

“But, why?” I ask again. I have actually struggled to come up with a simple response to why you could justify NOT putting something like this through your official review process, but hadn’t come up with something yet. As pharma expands its social media efforts, at some point, this becomes a major issue. Are you going to review every tweet, every Facebook status update, and every “Hi, welcome to our forum” comment? You must either really love those regulatory meetings or you really have way too much spare time. Clearly, this isn’t going to be practical. At some point, you have to trust that people will do the right thing and follow the rules without reviewing every single thing they say before they say it.

Crazy…I know. Or is it? As I said, I struggled for a way to simply explain why this isn’t pure madness. It came to me while in the discussion at the conference. My epiphany came courtesy of Brad, who I mentioned earlier. He had the perfect analogy. I’m going to paraphrase just a bit, but here’s the gist:

When someone calls your company’s call center with a question about your product, do your representatives answer the question or do they tell the person that you’ll get back with them in 2-3 weeks?

Not to be outdone, Steve Woodruff, added to this (again paraphrasing):

When your reps are talking to a doctor and the doctor asks a question about your drug, does the rep have to pre-clear a response and get back with the doctor 2-3 weeks later?

Think about both of those statements for a minute. Obviously, we don’t make our call center representatives or sales reps wait for our regulatory process to review their answers before responding to a customer’s question, so why would we have to do this to respond to a customer question on our company blog? Do we trust our sales reps more than the person responsible for our blog? Do call center people get a special set of rules?

I don’t know the answers. I really don’t. You might argue (especially if you’re a lawyer), that the blog response  is “on paper” and therefore, more discoverable while the two analogies are just conversations that aren’t recorded. I suppose it would be harder to “get in trouble” if they aren’t recorded. Of course, this doesn’t put too much faith in your representatives to follow the rules and, the last time I checked, we had these things called voice recorders. If someone really wanted to get you in trouble, they could. Does anyone know the answer to this? I’m not saying that you should let every Tom, Dick, and Harry at your company respond to blog comments, but shouldn’t someone be allowed to do this without having everything approved before they say it?

One final comment that was said around this discussion came from Xavier Petit from Shire. His point related to the fact that we simply can’t ignore that people want to talk to us, so, basically, we have to respond when they come to us. We can’t just ignore them. His analogy was something like this (again, paraphrasing because I can’t write fast enough):

When we realized that people were going to call us on the phone when we gave out our number, did we suddenly decide to cut all the phone lines?

Of course not, but isn’t that what we’re doing when we don’t respond when someone asks us something via a social media channel? We create places for people to comment, but when we realize that they’ll actually do it, we cut off the communication. Actually, it’s exactly the same thing.

So, why are you still here? Shouldn’t you be calling your IT group and telling them to turn off the Internet?

The Only Way Pharma Can Improve Compliance: Fun

[Quick disclaimer: I'm using "compliance" and "adherence" a bit interchangeably in this post. I know they're different, but I'm going to spare a big debate. Just go with it. Thanks.]

I’ve been involved in a few discussions lately about how pharma can  improve compliance to their medications. Of course, this isn’t the first time I’ve had these discussions and, likely, it won’t be the last. Part of my last job at AstraZeneca was managing our compliance program for their breast cancer products. If you’re in pharma, you know that this debate has been going on for years. Within the last five years or so, interest has really picked up in this area likely because someone really started crunching the numbers. As pharma sales growth has slowed, they’ve needed to look at different ways to sell more of their products. A seemingly obvious place to start is compliance. If you do some quick math, you figure out that if you can get people to stay on treatment, you can put hundreds of millions, if not billions, of dollars to the company bottom line. Seems simple enough…

Somewhere around a third to a half (or more) of patients don’t take their medications as prescribed. If you want to see a ton of stats about this covering a bunch of different diseases, check out the ultimate in compliance resources, AlignMap. Oh, and by the way, maybe you’re thinking that those patients who are non-compliant are those with less serious diseases. You’re wrong. From AlignMap citing multiple sources…

  • Approximately half of the patients who chose to undergo the pain, risk, and emotional trauma of a kidney transplant do not adequately follow their medication regimen prescribed to prevent rejection, and 25% regularly miss doses of prescribed medications.
  • In one study, 58% of patients with glaucoma who were told that failure to use their medication would result in blindness were noncompliant; 42% of patients who had already lost sight in one eye after they failed to comply with their medications persisted in their noncompliance.
  • Another study estimated that half of those surveyed had missed doses in the two weeks prior to the survey, although they believed the medication to be effective and potentially life-saving.

That’s a problem.

It’s a problem we’ve tried to fix for a long, long time. And, we’ve tried a lot. Here’s a list of the most common compliance interventions out there (again, credit to AlignMap, take the hint and check it out):

  • One on one counseling
  • Educational videos, brochures, and tapes
  • Court mandated and monitored treatment
  • Promotions of self-reliance and self-efficacy
  • Improved patient-clinician communications
  • Directly observed therapy
  • Mechanical or electronic reminders
  • Adherence programs provided by a pharmaceutical manufacturer
  • Automated or personal phone calls or email
  • Disease management programs
  • Celebrity endorsements
  • Public Service Announcements
  • Simplification or alteration of regimes
  • Assistance to increase accessibility

So, how many of these have you tried at your company? How many have made a big impact? The reality is that very few interventions make a significant difference in compliance rates. We haven’t figured out the magic bullet. If we had, we wouldn’t still be having this conversation. For my part, I believe the reason we haven’t made an impact is because we test and use one intervention at a time. That is, you create a text message reminder program to improve compliance. But what if I don’t use text messages? What we need to offer is a wide choice of different compliance programs with each individual enrolled in the programs that are going to impact them. Of course, this might not be completely practical, as it would require you to create twenty (or more) different compliance programs (see the above list) so that each person had enough choice. That could get pricey. Sorry to say, but likely that’s what’s going to be the thing that significantly impacts compliance when the first company decides to take the plunge and create a comprehensive platform like this.

In the meantime, let’s look at something different. Let’s try something not on the list…something that hasn’t been done before. It’s called fun.

Perhaps you’ve heard of it (from Merriam-Webster).

FUN, Pronunciation: \ˈfən\, Function: noun

Etymology: English dial. fun to hoax, perhaps alteration of Middle English fonnen, from fonne dupe

1 : what provides amusement or enjoyment; specifically : playful often boisterous action or speech <full of fun>

Okay, glad I could remind you. Fun. You like fun, right? Not much from that list above appears to be fun. So, what does fun have to do with drug compliance?

Maybe everything.

Watch what fun can do…

Now, if the pharma industry (myself included perhaps) was asked to increase the number of people who chose the stairs, we’d probably do it a little differently. Likely, we’d put up some signs that show the benefits of exercise on cardiovascular disease (and you know we’d use the word “cardiovascular” a lot). We’d also probably tell you about the risk of not getting enough exercise. Maybe we’d even get a celebrity that we could put on the signs (or make cutouts)…I’m thinking one of those trainers from “The Biggest Loser” would be great. And, we’d probably put in some sort of flashing light to call attention to the people who decided not to take the stairs.

Ho hum. All of those things have one thing in common…they aren’t very fun.

I was recently at a great meeting (in Iceland) where I met people from many different industries. One of the people I spent a lot of time with was Toby Barnes who is Managing Director for a company called Mudlark. This company does a lot, but in the end, they’re a company that makes games. Toby has incredible passion about gaming, but he’s not the guy who sits in front of the XBOX all day. He simply believes in the power of games to change behavior. Toby really just wants to create fun. One of the many things he told me that stuck with me was really simple. I’m going to paraphrase, but the gist was this: humans learn by playing. From the moment we’re born, through our most important developmental years, we learn by playing. The roles we play in life, how things work, what’s good and bad behavior, and how to communicate with others…all from playing. Somewhere along the way though, we stop playing and stop learning.

So, what is playing? Well, first, playing is supposed to be fun. Without that, the rest doesn’t matter much since no one will play with something that isn’t fun.

Let’s go back to the Volkswagon video. They created something fun, something people played with. People saw that taking the stairs could not only be fun, but also that it wouldn’t kill them to do so from time to time. We all know that we should take the stairs more often. It’s a simple way to improve our health that’s available to almost everyone no matter where they are. But, just like our medications, we don’t do what we’re supposed to do. By simply changing the way we encourage people to change their behavior, we can create something different, something that might just work.

Digital technology makes it really simple to create fun and engaging games–games that can teach us to change our behavior while we’re doing something we enjoy. When I mentioned earlier that I had an idea that wasn’t on the list above and hadn’t been tried before, I wasn’t being totally honest. You see, someone has taken this approach in healthcare…and it worked. I actually wrote about this a long time ago in a post called Gaming To Save Healthcare Marketing.

The greatest example of fun leading to a behavior change in healthcare is Re-Mission. This game was created to help kids fighting various cancers. It’s essentially a first-person shooter-type game, but you’re battling the disease.

Re-Mission

Well, isn’t that nice. They created a game for kids fighting cancer to help them pass the time during treatment. Right? No. This game was designed to improve outcomes. In fact, the company behind this game, Hope Lab, conducted a randomized trial to test the game’s effectiveness. Half played Re-Mission and half another video game. The results were published in the journal Pediatrics. Here are some high points:

  • “Self-efficacy and knowledge were significantly improved in the intervention group compared with the control group.”
  • “Adherence to at-home medication (trimethoprim-sulfamethoxazole and 6 mercaptopuring) was significantly improved in the intervention group compared with the control group.”

Yes, you read that right: “Adherence to at-home medication was significantly improved.” How did Re-Mission manage to do this? The game is fun and, if we follow Toby’s logic, we learn by playing. That’s just what happened here. These kids learned about their disease and its treatment by playing. Not only that, they learned by playing something they enjoyed.

Perhaps this is the real key to improving compliance. It’s not about creating fear-laced predictions. Not about creating nagging reminders. Not about creating tedious tracking tools. And not about spying on people. These are the things we do in most of our compliance programs today. They aren’t working like we need them to, so isn’t it time to find something different?

PS: There are a couple more experiments beyond the stairs that Volkswagon tried. All with the idea of fun, check out what else they managed to do:

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