Shire Gets Warning Letter for YouTube Video

by shwen No Comments »


A little delayed on my part, but thanks to Mark Senak of EyeOnFDA for the tweet-alert that notified me of Shire’s Warning Letter (PDF file) from DDMAC last Friday (SEP 26th — my birthday!), regarding their promotion of a YouTube video for Adderall XR. Here’s an excerpt of what was stated in the letter:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a webpage and a video testimonial featuring Ty Pennington posted on youtube.com by Shire Development Inc. (Shire) for Adderall XR® Capsules (Adderall XR). Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use. Additionally, the webpage broadens the indication for Adderall XR by suggesting uses that have not been approved by FDA… The webpage and video raise significant public health and safety concerns through their overstatement of efficacy and omission of important safety information.

This is the first case of a DDMAC Warning Letter that I know of which specifically targets a video on YouTube, indicating that the the FDA is definitely paying close attention to these new and emerging distribution channels. However, while this case does specifically reference YouTube, it is important to note that it’s NOT YouTube itself or the medium/channel that is the issue, but rather the content. In other words, the online video comes under the same standard of regulation and scrutiny as traditional mediums, such as print or DTC television ads. Mark Senak very succinctly sums it up in the following sentence: “Again, the lesson here is that it is the message, not the medium, that trips the regulatory tripwire“.

You can read more commentary about this case here or, additionally, John Mack — over at Pharma Marketing Blog — also has an interesting interpretation of this case, as usual. Here’s a quote:

By the time the FDA issues a warning letter about a DTC ad that violates FDA regulations — as it did on September 25, 2008, for a video testimonial featuring Ty Pennington posted on youtube.com by Shire — the cow has long left the barn… The Ty Pennington Adderall XR video can no longer be found on YouTube, which proves that Web 2.0 Tricks work! (see “Web 2.0 Pharma Marketing Tricks for Dummies“).

With the rise of pharma related YouTube channels, this should be an interesting space to watch. And whatever the case, if you’re thinking about launching healthcare related videos online (e.g. via YouTube or other video sharing sites), I don’t think this Warning Letter should be a deterrent for using the medium whatsoever.  As stated so eloquently by Mark Senak:

Companies still leery of the use of video should perhaps start with unbranded messages that are about disease awareness. But the existence of a warning letter aimed at a YouTube promotion should not influence the use of YouTube any more than a warning letter for a print ad that simply does not address regulatory parameters would stop print ads.

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Online Video Growing in Popularity Among Physicians

by shwen 1 Comment »

Last week was really busy for me, not least because I was catching up with work after being away at Web 2.0 Expo @ NYC the previous week, but also because I had out-of-town relatives visiting, etc. So, I’m playing catch up once again…


Image from Plugging Into Physicians white paper from Manhattan Research

Anyway, not too long ago, I blogged about the rise of YouTube channels among pharma, as a means for engaging consumers. In terms of new and emerging media channels, I’ve noticed that over the last couple of years, online video consumption also appears to be a growing trend among physicians as well.

In every market research report and/or segmentation study that I encountered in the last 2-3 years, it appeared that online videos were clearly growing as one of the fastest of all communication channels with physicians, while more traditional channels — such as teleconferences and dinner meetings — seemed to be on the decline.

So, a couple of weeks ago, Manhattan Research (MR) released a SEP 15th press release from their ePharma Physicians v8.0 study, reporting that there is also a growing interest among physicians for live video details from sales reps. Here’s a brief excerpt from the report…

Physician interest in live video detail from sales reps is growing… Currently, about 45,000 U.S. physicians meet via online video with their sales reps, and over 300,000 more show interest in interacting with sales or other company representatives online.

Physicians already engaged in video detailing with sales reps are, for the most part, highly satisfied with their experience, according to the study. This sentiment may explain why these physicians are consistent users – physicians already participating in live video detailing sessions do so with an average of seven reps per month…

"Incorporating live video details in the physician-sales rep relationship can be a win-win for both groups,” said Meredith Abreu Ressi, Vice President of Research at Manhattan Research. "…Pharma companies should pay close attention to rep call centers that give healthcare professionals access to company representatives via telephone or web chat at any time, as many physicians express interest in this type of service".

Similarly, an earlier press release (AUG 13th) from the same study reported that "physicians expect to shift more time to online professional resources in the coming years"…

This year’s survey found that physicians desire to receive the majority of their pharmaceutical and device product information through online and other electronic sources. Currently, physicians conduct 41% of their pharmaceutical research online, but expect to increase that percentage to over 50% in the near future.

"This trend could prove to be an opportunity for smaller and targeted specialty pharmaceutical and biotech companies to gain ground on larger competitors in physician reach and market share through cost effective digital sales and marketing support strategies," says Mark Bard, Manhattan Research President. "Digital channels have leveled the playing field in many industries, giving sales and marketing groups the chance to make a big impact even with limited – yet targeted – resources."

Online journals and virtual conferences are two other professional resources that should see spikes in physician traffic in the coming years. The study found that physicians expect to shift time spent with print journals and live conferences to those online counterparts.

I guess all this should come as no surprise, as physicians start taking charge of their own consumption of media (just like consumers are doing), especially in this day and age, where there are so many hospitals that turn reps away and so many competing healthcare events for a physicians time. Furthermore, the online channel not only provides an on demand service that has almost limitless resources, but it’s also convenient in that it can be consumed in the office, at home, or any number of connected mobile devices; whenever the physician has some down time.

For a brief overview of their ePharma Physician v8.0 study findings and more, check out the following resources from Manhattan Research:
- First of a four-part podcast series providing an overview of the study (3 mins / MP3 file)
- White paper on "Plugging into Physicians"
- Their regular podcast series on eHealth Trends (usually <10mins each)
- Watch their webcasts (note: registration/request required)

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Pfizer Taking Big Strides in Social Media: Twitter, Facebook, Micro (Health) Finance

by shwen No Comments »

A few weeks ago, a good friend sent me a link to a short article from New Media Age (via Therapeutics Daily) about Pfizer’s roll out of “…a pan-European digital campaign encouraging people to stop smoking” using viral marketing (read: social media). According to the article…

The Serious Quitters’ Arcade marks the brand’s first venture into viral marketing. The games site is being pushed through Twitter activity, video seeding and a Facebook app based on arcade game Pac-Man.

Pfizer has appointed viral agency GoViral for the push, and Belgium-based digital agency Emakina for the site that will feature games and information on quitting.

Visitors will be encouraged to add the games from the arcade on their blogs. Chris Venn, European brand manager at Pfizer, said, “We need to be able to demonstrate that our campaigns have a certain reach and are worth doing and online lets us be accountable.”

It’s interesting to see that Pfizer is trying to engage it’s audience through the use of social media channels where their audience is (i.e. Twitter and Facebook). This makes even more sense in Europe, where smoking is probably more prevalent and more acceptable, especially among younger folk.

However, if the plan is to use these tools simply as a method to “re-direct” people to the arcade website, I’m not sure if that will work quite as well. Perhaps why they called it “viral marketing” instead of social media.

IMHO, a big difference between traditional marketing and social media is that the former really doesn’t take as much effort after the launch of the campaign, other than to monitor and analyze; whereas with social media, the big effort really starts at the launch, as the tools are designed to facilitate interaction and engagement in order to develop an ongoing relationship with the customer. And like with any kind of relationship, it takes effort, empathy, and regular communication in order for it to blossom and grow. A one time effort with no continuing engagement will lose the interest of the social media audience very quickly, especially if it’s just marketing/advertising in disguise.

OK, getting off my soapbox now… So, in addition to the use use of social media, I recently came across an article that announced Pfizer’s “…novel partnership [with Garmeem Bank] to explore sustainable healthcare delivery models for the developing world“. Here’s an excerpt from the article:

Pfizer Inc and Grameen Health, an affiliate of Grameen Bank, the pioneering micro-financing organization in Bangladesh that shared the Nobel Peace Prize in 2006 for its work to alleviate poverty, today announced that they will work together to identify sustainable models for healthcare delivery in the developing world.

The partners will jointly evaluate ways to improve Grameen Healths existing healthcare delivery systems and primary care clinics in rural Bangladesh. At the end of one year, they will identify appropriate business models that ultimately can be replicated in other countries, addressing the needs of the 4 billion people around the world whose annual income is less than $3,000. As part of its commitment to the collaboration, Pfizer is dedicating key employees to provide technical and advisory support…

During the next year, the partnership will focus on the following areas:

  • Analyzing ways to expand and improve the current low-cost micro-health delivery and insurance programs at Grameen Healths 38 existing Kalyan clinics.
  • Reviewing operating efficiencies and scope of services (e.g., telemedicine, mobile healthcare) at Grameen Healths Kalyan clinics.

Graarmeen is well regarded in the area of micro-finance — a concept that is very “2.0″ in nature — so Pfizer’s support of this mission is very impressive and definitely goes beyond just viral and social media marketing. It’s a commitment to help improve healthcare in places that need it most. Very glad to see them jumping in on this type of endeavor as a key industry leader working towards more than making profits from Web 2.0 trends.

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CDC: Innovative Web Dialogue About Interactive Media & Health

by shwen 2 Comments »

I’m currently at the Web 2.0 Conference in NYC, but just came across this blog post by Fard Johnmar on a great opportunity to participate in an “innovative discussion with the Centers for Disease Control and Prevention on technologies for health communication and public health” — here’s what was posted about the discussion on the CDC website:



Welcome to CDC’s National Center for Health Marketing Division of eHealth Marketing Web Dialogue on Web 2.0 and Health Marketing. This online discussion will look at how interactive media applications fit into health marketing and health communication efforts. In particular, we will focus on blogs, social networks, media sharing, and other Web 2.0 tools.

Plan to share the experiences and successes you’ve had in using Web 2.0 applications so other participants can learn from your work. But we also want to hear about challenges and barriers you’ve encountered. If you’ve had little or no experience, we need to hear from you too! You’re in a great position to ask the questions that will help you better understand interactive media and how it might fit with your work. Thank you for joining in this Web Dialogue on Web 2.0 and Health Marketing.

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Pharma YouTube Channels on the Rise: JNJ, Abbott, GSK, etc.

by shwen 3 Comments »


As mentioned not too long ago, I wrote about J&J leading the pharma world in launching a YouTube channel — JNJ Health. Well, I recently discovered (thanks to EyeOnFDA blog) that since then, some other pharma (and related) organizations have followed the lead and have launched their own YouTube channels as well, including:

1. Johnson & Johnson (JNJhealth) – Just launched an ADHD series
2. Abbott Labs (Abbott1888)
3. GSK (GSKvision)
4. PhRMA (SharingMiracles) – Industry trade organization
5. Eye On FDA (EyeOnFDA) – Aggregating all the above pharma channels

Apparently Liliy also started a “LillyDiabetes” YouTube Channel, but that mysteriously dissapeared a short while after it launched. In fact, here’s what Mark Senak (EyeOnFDA) had to say about the LillyDiabetes channel before it dissapered:

I didn’t expect Lilly to enter this space so early, given the fact that they still send out their press release updates by email and not RSS Feed like most large pharmaceutical companies. (That is like using the U.S. Postal Service snail mail instead of email.) But, what they have done is brilliant in
notion, if not execution.

Lilly has started a disease-specific channel to appeal on diabetes called LillyDiabetes. This is frankly a great idea and exactly the kind of thing I’ve been preaching here. If you want to see them, go to LillyDiabetes, or join me on the Eye on FDA channel, where I’ve placed them into a special Diabetes Playlist.

It’s too bad that I didn’t get a chance to see it before it went away, but it sounds like there wasn’t much of a real effort put behind it’s promotion anyway… “The Lilly channel only has 3 subscribers, I became the 4th this morning, even though it has been open for 8 weeks“.

So, for any other (Pharma) organizations that wish to launch their own YouTube channel, Mark goes on to offer some really good suggestions on how to succeed in this space:

  • Issue an Web News Release (WNR) about the launch of the channel. If you don’t know what a WNR is, call me.
  • Do some online editorial outreach (OEO) to key bloggers in this space to let them know of the launch and offer interviews with those behind it in print or podcast form regarding the launch, the objectives and the makeup of the channel. If you don’t know how to do OEO, call me.
  • Get a linkage strategy going. Consider creating a widget with a link to your channel for putting up on key sites – like Lilly should have a Diabetes Channel Widget made up that could go onto the sites of large diabetes organizations and places where people with diabetes or at risk go for information, that would link them to the vids. If you don’t know how to do a linkage strategy or make a widget, call me.
  • Consider allowing partners to post their vids on your channel. Are you going to be a C-Span, where you just show your own vids – or a Bravo – a channel that buys programming and puts it on their channel? By combining partners, you combine appeal and following of others to your own cache. Of Lilly’s 28 vids, most of them are vids produced by other sites. Perhaps you lose control over message, but you allow consumers/patients choice and variety.
  • Put together an editorial calendar to let us know what’s coming, kind of like a TV Guide, so we can look forward to it and promote it ahead of time.
  • Mention the channel on your blog, if you have one, like Johnson & Johnson’s blog – JNJBTW.
  • Put it on your Web site (duh) prominently.
  • Open a Twitter account (see my paper on New Media and Public Affairs). Twitter about your YouTube channel. (My twitter account is followed by several media outlets and even some government outlets).
  • And oh, if you don’t know how to set up an RSS Feed for your press releases – yes, call me!
  • And oh yeah, send out a press release.

And for your additional reading pleasure…here are some of the related links (from Eye on FDA) to various pharma YouTube Channel posts:
- http://www.eyeonfda.com/eye_on_fda/2008/09/johnson-johns-1.html
- http://www.eyeonfda.com/eye_on_fda/2008/08/another-pharma.html
- http://www.eyeonfda.com/eye_on_fda/2008/08/abbott-has-yout.html
- http://www.eyeonfda.com/eye_on_fda/2008/08/eye-on-fda-open.html
- http://www.eyeonfda.com/eye_on_fda/2008/08/gsk-opens-up-ne.html
- http://www.eyeonfda.com/eye_on_fda/2008/07/johnson-johnson.html

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Marissa Mayer on Product Management and Small Teams – Interview by David Eckoff, Part II

by shwen No Comments »

Shortly after I posted the “Interview with Marissa Mayer” entry, I received a comment from my friend David Eckoff (author of the original posts), informing me that he was just about to post Part 3 of his interview. He also reminded me our lunch in California during the 2007 PNME, which made me miss In-and-Out burgers tremendously — it used to be a frequent staple when I lived in San Diego…But I digress…

Anyway, I checked out his blog and realized that he’s not only got Part 3 up, but Part 4 as well. Part 3 talks about Google’s philosophy for Product Management and Prototyping and Part 4 talks about Small Teams and Leapfroging

Once again, Marissa’s answers tied in very nicely with the previous topics on innovation and culture, reminding us of the holistic approach that drives Google’s innovation. Everything from the “top down AND bottoms up approach”, “launch early and iterate often based on feedback”, “20% time”, and “disrupter teams” are just a few examples. Here are some quotes from Part 3 and 4 of the interview…


Image by jwowens; from DavidEckoff.com

DE: Could you talk about the product management process at Google, how you go from idea to product, a high level overview?

MM: Every product has its own genesis. But we gather ideas from all over the company. Some of the ideas are top down…A lot of the ideas are bottoms up, engineers and other employees coming up with ideas and prototypes of what they’d want to build… We try to put a small team on it, sometimes a volunteer effort with what we call 20% time.

20% time is a notion we have at Google that we want employees to work on whatever they want to work on regardless of it is part of their core assignment with about 20% of their time… And then we launch it. We try to send it out to Google Labs as quickly as we can.

We try to launch early and often and then change the product, iterate it based on user feedback, adding more resources as something gains strength and popularity.

DE: What kind of return on investment do you see with 20% time?

MM: We call it 20% time, that’s our slogan that provides our employees with a creative license to know they are empowered to spend 20% of their time to do whatever it is they feel most passionately about. Because we believe it is that kind passion that creates really great and beautiful products. At the end of the day it’s about building something that you think will be particularly powerful.

What we’ve found is that often supports the core and gives us a disproportionate return on investment.

DE: If you were to go to work at a company more mature in it’s lifecycle, what would be your approach to innovation and new product development?

MM: I think 20% time, letting your employees know that you trust them and that they’re empowered to work on the things that they think could have the biggest impact on the business or that they think could be most impactful for the world is an important idea and I think works largely everywhere.

And there are key elements that we look at in terms of overall metrics and trends that you want to coach the organization towards. One of them is small teams… So there’s a conscious decision to sacrifice some element of quality and polish for the sake of doing more things and having more of a breadth of efforts going on… The other nice benefit this has is it keeps the culture much more entrepreneurial and much more motivated. Because when you’re working on a smaller team you have a much greater sense of ownership…So I think by creating a culture that has those small teams, you’re much more likely to get innovation… That’s true in start ups, that’s true in large companies.

And then there’s the concept of leapfrogging. We’ve noticed that as Google has matured as a company, some teams, while they may be structured in smaller teams within them, they’re large teams…What we’ve noticed there is when we add a small disrupter team, that’s supposed to think about things in a new and different way, two bad things happen.

One, the large, experienced, mature team wants to talk with the disrupter team, and say, “I know that seems like a good idea, because it seemed like a good idea to us too. But we tried it, and it was a waste of a year. So please, don’t bother to do that”… The other thing that happens is usually that big team is successful, and they have a lot of tools and infrastructure that the disrupter team wants to draft off of. So as a result, in a big company with a large successful team, it’s difficult for the disrupter team not to get sucked into the larger team over time.

We’ve had a bunch of attempts at leapfrogs, such as in search, with a team in Kirkland trying to build a better search engine than Google itself. And I’m not allowed to talk with them [laughter]. And that’s a good thing, because I know they’re wasting time.

I know they’re doing things we tried that just don’t work [laughter]… I’d love to talk with them and I’d love to save them that effort. But that very action of me doing that would ultimate change their outcome and change how disruptive they can be. So it’s really important that I not talk to the Kirkland search leapfrog and let them do their thing.

Again, you want to keep a small team. But you also want a disrupter to be far enough away that they don’t get overly influenced or voluntarily pulled into the larger, more successful team.

Personally, I believe that this is a case of driving innovation — particularly from the bottom up — by empowering people to pursue what they are most passionate about and creating an environment that encourages disruptive innovation.

How many of us in corporate environments can’t even get an idea heard/supported or have to deal with so many internal political channels that the idea itself ends up being the least of your concerns? We spend waaay too much time in meetings, avoiding toes that we shouldn’t step on, executing questionable plans from the top down, and trying to convince people who don’t (want to) understand the benefit of what you are proposing, that we don’t have time to actually do anything about the idea.

What if you told your boss that you were going to spend 20% of your time just working on an idea that you are passionate about that might benefit the company? What about just 10%? What if you said you’re going to work on the very same thing the larger group worked on and failed, but you’re going to do it different/better? Hmmm….Somehow, I don’t think it’ll fly…But that’s exactly the kind of thinking that drives the Google’s innovation factory.

Anyway, I apologize for the amount of quoted text in this post, but David’s “Interview with Marissa Mayer” series (Part 1, 2, 3, 4 so far) is so full of concise information that is filled with so much insight that it’s difficult to leave a lot of stuff out — I highly recommend giving it a read! And in case you didn’t see it before, you might also want to read my 2006 post on
A License to Pursue Dreams: Google’s Innovation Equation.

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