Monday, June 29, 2009

What Pharma Should NOT Learn from P&G and Pringles

My fellow blogger Jonathan Richman suggested that pharmaceutical marketers should follow the lead of P&G to create banner ads similar to the award-winning Pringles ad that Jonathan's agency created (see "What Pharma Can Learn from Pringles").

Jon, Congrats on the Pringle banner ad award! (See and play with the ad here.)

Jon suggests this ad could be a model for pharma:

"Imagine that Pringles was a pharma product for a minute. There’s no fair balance here, but it wouldn’t require it. The brand name is mentioned (if you click a few times), but nowhere does it include the 'indication:' potato crisps. I guess this makes this banner a reminder ad then.

"We pharma people love and hate reminder ads. We love them because we can promote the brand without the clutter of fair balance, but we hate them because we can’t get in any key messages. Regardless, pharma spends a lot of money on these. My point? If Pringles were pharma, this ad would be regulatory compliant. Just saying."

Pharma should not "love" drug reminder ads, at least those pharmaceutical companies that have signed on to PhRMA's guidelines for DTC (direct-to-consumer) advertising, which banned them on TV (but not, alas, in print or on the Internet). PhRMA says: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." Shouldn't that be best practice on the Internet as well? After all, DTC advertising is supposed to be educational according to PhrMA.

Guidelines or not, I would say no to this kind of banner ad for branded drugs simply because of my general distaste for drug reminder ads. Reminder ads may be fine for brands as well-recognized as Pringles and Viagra, which have nothing really new to say about themselves. But for a new drug, or a complicated drug, or a drug with a new indication, etc., how can you justify such an ad?

I would remind readers, BTW, that P&G claimed in an UK court that Pringles was NOT a "potato crisp" but a "savory snack." That's because it is only 40% potato! Maybe that's why it has resorted to a reminder ad! Just saying.

Does Novo's Editing Suck the Life Out of Charlie Kimball? Yes, by Some Objective Measures.

Last week I compared the personal Twitter account of racecar driver and diabetes patient Charlie Kimball (@charliekimball) with Novo Nordisk's Levemir-branded Race with Insulin Twitter account (@racewithinsulin), which supposedly features tweets made by Charlie. In that post, I noted that the latter account is a distorted mirror of the former. In fact, it appears that Novo Nordisk is rewriting a select number of Tweets from @charliekimball to create the Race With Insulin account (see "Novo Nordisk Selectively Copies & Edits Kimball's Tweets").

It's no surprise that Novo Nordisk would edit Charlie's Tweets. After all, Novo is a regulated drug company and is responsible for the post made on its Twitter account.

But is Novo sucking the life out of Charlie's Tweets? A few of Charlie's more personal Tweets, for example, never make it over to Race With Insulin. These include: "In Denver airport on my way home. No one has ABC and the race on. It's all golf! Bleh." and "Just had a great mountain bike ride. 1 hr. 40mins. 20 miles. 1850 feet ascended. Lots of fun!"

What we are left with is a string of Tweets about Charlie arriving at airports, cleaning his suit, and taking his Levemir. Novo's editing, in other words, doesn't leave much that would make us interested in following Charlie on @racewithinsulin.

Is this a case of marketing "sucking the life" out of a person? (see "Was Nalty's Fart Video the Straw that Broke Merck's Back or was it Some Other Video?").

That's my personal opinion based on my qualitative analysis. There is, however, another more quantitative analysis available. The site TwitChuck.com, which bills itself as "an intelligent way of looking at spam and following on Twitter," uses "use a collection of metrics ranging from social interaction, to friends and followers, spam rules" to score each Twitter account you feed into it.

I decided to compare the TwitChuck scores of @cahrliekimball and @racewithinsulin to see if there were any significant difference between them. Here's what I found this morning (click on the image for an enlarged view):

Another quantitative Twitter tool is Twitalyzer.com, which evaluates the activity of any Twitter user and reports on relative influence, signal-to-noise ratio, generosity, velocity, clout, and other useful measures of success in social media. The Twitalyzer scores for @charliekimball and @racewithinsulin are shown below (click on image for an enlarged view):

The two main reasons why @racewithinsulin scores lower than @charliekimball is that the the former is decidedly less social than the latter. Novo allows @racewithinsulin to follow no one, does not allow direct messages from any one, and does not communicate with any one. It is, as TwitChuck says, "using Twitter as a one way information stream." Obviously, this is a safe way to use Twitter's advantages without having to deal with handling adverse event reports or off-label comments from followers.

@racewithinsulin is evolving. For one thing it is adding new followers, although many of them appear to be PR and marketing professionals rather than diabetes patients. On the basis of this alone, I expect its socres to increase over time.

However, if Novo Nordisk wishes @racewithinsulin to evolve into a inspiring resource for diabetes patients, it will need to rethink its editing policy to allow more interesting Tweets through from Charlie. I won't even get into the two-way conversation thing! It may just be too big a regulatory nut for Novo or any other pharma company to crack.

Friday, June 26, 2009

Acromegaly Answers Blog Raises Interesting Regulatory Question

My friend @skypen just Tweeted me this request: "John, interesting social media initiative by Tercica for niche patient community. Would love your thoughts." See his summary post "Compass launches blog and webinars for niche community."

I'll focus on the Acromegaly Answers Blog, which "posts blogs from patients, caregivers, patient service specialists, nurses, doctors and others who live with and manage acromegaly every day." Ipsen, a global pharmaceutical "Group" based in France, sponsors this blog.


According to MedAdNews, "Comments are approved by the med legal team and is moderated in collaboration between Compass and Ipsen regularly and checked at least once every 24 hours, usually every 12 hours, so that if there is any adverse events they can be reported in the appropriate timeframe."

I applaud that commitment to handling AEs that may be discovered via this blog. However, I believe that the blog's disclaimers about who is responsible for the content will raise some issues with the FDA.

At the bottom of the blog page is included these disclaimers:
"Comments that appear on this blog are the opinion of the poster, not Ipsen, and may or may not be accurate."

and

"This blog is moderated. Your inputs may therefore not be posted. Still, you remain responsible for the content of your inputs."
These disclaimers -- especially the first one -- contradict what I heard Preeti Pinto, Executive Director, Promotional Regulatory Affairs at AstraZeneca, tell the audience yesterday at CBI’s 2nd Annual Bio/Pharmaceutical Emerging Media Optimization for Consumer-Focused Marketing conference.

Pinto essentially said "If you sponsor it, you are responsible for the content" as far as the FDA is concerned. She also said, I believe, that when you moderate comments submitted and post those comments, you are also responsible for the content.

What do you think?

Is Ipsen responsible for content on its sponsored Acromegaly Answers Blog?
Yes
No
Maybe
I have no idea!

My First Tweetup! A Good Idea for Pharma Media Relations People

Several stars of Pharma Twitterdom tweeted away continuously during yesterday's Emerging Media Conference hosted by CBI (see tweets: #Pharmedia).

In attendance were @askmanny, @swoodruff, @jonmrich, @philbaumann, @sixuntilme, and me (@pharmaguy).

I arrived a wee bit late and could not get a seat at the Twitter stars' table, which was equipped with a power outlet! I sat way off to the side where I could plug my notebook into a nearby wall socket to recharge my PowerBook's battery.

Someday, I will get a seat at the table with the big Pharma Twitter guys and gals. At least, however, I attended a Tweetup with a few of them after the meeting at McGillin's Olde Ale House, Philadelphia's oldest continuously operating tavern, where I poured Farmhouse Ale for the gang (see photo courtesy of @woodruff's new iPhone aided by Photoshop image enhancement).

What's a Tweetup? It's simply a real world meeting of people who use Twitter. It's a good opportunity to meet the people you follow or who follow you on Twitter.

This particular Tweetup was open to anyone in the Philadelphia area who heard about it through Twitter or wherever one hears about these things (I'm sure there's an app for that on the iPhone). One of the organizers was Neal Wiser, a digital marketing professional (@nealwiser).

At first, I was a bit wary of going to a Tweetup in an Irish pub, especially one billed as "Olde." Where I grew up -- in NYC -- geeks and Irish drinking establishments did not mix!

As us geeks walked down the seamy alleys parallel to and behind Broad Street looking for McGillin's, I wondered if my first Tweetup would be my last. Luckily, however, McGillin's and the Tweetup organizers had the foresight to isolate us on the second floor, away from the regular pub patrons!

Most of the attendees were younger than us pharma Tweeters. Surprisingly, there were as many women in attendance as men. It was then that I realized that Tweetups like this were good places where single (or married) men and women could meet for purposes other than sharing Twitter stories! Of course, that was NOT our interest! We appropriately sat at our own table and behaved.

It occurs to me that my colleagues who work for pharmaceutical companies and who use Twitter should attend Tweetups in their area. Better still, they should organize their own Tweetups.

Marc Monseau, Director, Media Relations at Johnson & Johnson, often invites bloggers to dinner at fancy restaurants (see "Thank You Johnson & Johnson for Dinner"). It's an expensive proposition that is perhaps a bit too formal.

Media relations people want relations with media people -- reporters and bloggers. What if, instead of inviting these people to dinner, Marc (and other pharma media relations people) organize their own Tweetups? Most Tweetups are held at restaurants or pubs that have separate rooms or areas that can be set aside for the group. You wouldn't do this at trendy places, but at places that need and welcome the patronage. Pubs and Taverns are perfect venues, especially for reporters.

One thing that would be a problem is who pays? Each of us at last night's Tweetup paid for our own food and drinks -- a grand total of $13 (including tip) for each of us (you can get a half-pound hamburger and chips at McGillin's for $4.99)!

Now that Marc has conditioned us bloggers to expect fine food and drink on J&J's tab, it may be difficult to get us to pay our own tabs at a Tweetup. Even the most destitute blogger, however, can pay his/her own way if we're talking about a tab under $20. Perhaps door prizes can be used as an incentive to attend.

All I know is that for $13 out of pocket, I had a great time at last night's Tweetup even though I did not win anything or walk out with a new BFF.

Wednesday, June 24, 2009

Marketing Mix of Leading Pharma Advertisers in 2008

Fourteen (14) pharmaceutical companies made it into AdAge's 2009 list of Top 100 National Advertisers (based on 2008 ad spending data). They are, in descending order of total ad spending:
  1. Johnson & Johnson
  2. GlaxoSmithKline
  3. Pfizer
  4. Bristol-Myers Squibb Co.
  5. Eli Lilly & Co.
  6. Bayer
  7. Schering-Plough Corp.
  8. Merck & Co.
  9. Wyeth
  10. AstraZeneca
  11. Novartis
  12. Boehringer Ingelheim
  13. Abbott Laboratories
  14. Sanofi-Aventis
The list is based on "measured media" spending across 19 media and includes estimates of "unmeasured media," which includes direct marketing, product placement, and most notably, paid Internet search, which some analysts estimate is about 40% of the total Internet ad spend of companies in general.

NOTE: P&G, which is primarily a packaged goods company and one of the biggest ad spenders in the US, is not included on this list even though it may market a few pharma products. It was also not included in last year's analysis (see "Marketing Mix of Leading Pharma Advertisers").

The total spend for these 14 pharma companies in 2008 was $6,993,000,000 measured vs. an estimated $5,697,500,000 unmeasured. That represents 12.4% of the total spending in 2008 of the entire group of AdAge's TOP 100 National Advertisers. NOTE: Not all of this represents direct-to-consumer (DTC) advertising. Magazines, for example, include B-2-B publications (ie, medical journals focused on physicians).

I plotted the media mix for pharma advertisers vs. non-pharma companies in the list and came up with this (click on the image for a larger view):


Compare this to last year's data (see "Marketing Mix of Leading Pharma Advertisers") and weep:

Internet display ad spending still represents a very small portion of pharma's measured media spending (2.4% in 2008 vs. 3.1% in 2007). Non-pharma companies allocate twice as much of their budgets to the Internet than do pharma companies.

Two pharma companies -- Abbott and AstraZeneca -- stand out from the pack in terms of the percent of their budgets allocated to Internet advertising in 2008 (see figure below; click for an enlarged view).

Tuesday, June 23, 2009

Do Pharma Marketers Encourage Consumers to Self-Diagnose?

Fellow blogger Rich Meyer over at World of DTC Marketing Blog has some good advice for pharmaceutical marketers based upon a survey of physicians (see "Physicians: We're concerned that too many people are self diagnosing").
"Doctors," said Rich, "were annoyed at drug company sites that offer patients a survey to determine if they need the medication. 'My patients think that answering a few questions is the final word and they then want the medication even though more tests are often needed.'"
Rich suggested, among other things, "If 10 people take a health survey on your product website and more than 50% get a recommendation to talk to their doctor about the medication than your survey is probably too general and needs to redone."

I've pointed out this problem in previous posts (see, for example, "You Must Score Better than 84% on Viagra's Sexual Health Quiz to NOT Have Signs of ED").

In that post I wondered "What is the scientific basis for this self-assessment?" Are the questions and rating structure something that Viagra marketers have just dreamed up? Or is the quiz based on an independent, medically-approved source?

That leads right to another of Rich's recommendations: "Drug companies should provide, on websites and consumers brochures, recommendations for sources of credible health information such as AMA, ADA, Mayo Clinic, Harvard Health."

Pfizer, however, does not reveal the source of it's ED rating system. Therefore, site visitors can't judge whether or not to trust the results. Yet they may believe the results are science-based and walk into their physician's office with an ED "self-diagnosis" based on this quiz.

Rich's first recommendation is: "Clearly state that the information on product websites is for information/education and that no website can diagnose a patient. It has to be done based on recommendations from the physician including the possibility of more tests."

While a statement to this effect is routinely included in every drug website, it is not sufficient on its own to absolve the drug company from certifying the scientific merit of self-diagnosis questionnaires (often called "Questions to Ask Your Physician").

Despite the fact that many drug website self-assessments are not supported by cited scientific evidence, many proponents of direct-to-consumer (DTC) promotion -- online and off -- claim that information provided by drug companies counteract "bad" information that consumers get from other sources. IMHO, self-assessment "quizzes" found on most drug websites are part of the problem, not the solution.

Monday, June 22, 2009

Novo Nordisk Selectively Copies & Edits Kimball's Tweets

Diabetes patient and racecar driver Charlie Kimball is sponsored by Novo Nordisk's Levemir insulin injection. I've written about the Race with Insulin Twitter account, which supposedly features tweets made by Charlie, in previous posts to this blog (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!" and "Pharma Marketers Should Stop Blaming the FDA for Their Dysfunctional Social Media Marketing Efforts").

In response to a post I made about a branded Levemir tweet made by Charlie via his Race with Insulin account, I received this email message from a personal friend of Charlie's: "I happen to know Charlie ... I think he is a good guy and hate to see him hurt by this incident. I wonder if someone at Novo is adding in the marketing messages ... Charlie made a mistake by letting it go out."

That made me think that perhaps all the Tweets on Race with Insulin were written by Novo Nordisk or their agents. So, I did some research and found out that Charlie has another Twitter account (@charliekimball).

When you compare @charliekimball to @racewithinsulin, you discover a strange parallel universe.
  • @charliekimball has 163 followers (I am one) and follows 31 people
  • @racewithinsulin has 169 followers and follows 0 people
This tells me that the latter account is at best a mirror of the first. In fact, you'll find an almost one-to-one mapping of Tweets between the two. But there are slight differences. Here are some examples:
@charliekimball: "Finished 7th. Made contact with Pippa Mann halfway through after she was a lap or two off the lead. Happy with the result and the points!"
Becomes:
@racewithinsulin: "Finished 7th. Very pleased with the result. It was great racing under the lights! Headed back home to California tomorrow."
-------
@charliekimball: "Getting ready for qualifying. Still really warm and sunny." and "Qualified 8th. Was a good job for my first time here. Racing at dusk tonight-8CST. 115 lap race- watch it live at http://bit.ly/tU67v"
Becomes:
@racewithinsulin: "Qualified 8th. Solid effort for my first time here. It will be a long fun 115 lap race tonight at 8CST."
A few of the @charliekimball tweets never make it over to @racewithinsulin.

These include: "In Denver airport on my way home. No one has ABC and the race on. It's all golf! Bleh." and "Just had a great mountain bike ride. 1 hr. 40mins. 20 miles. 1850 feet ascended. Lots of fun!"

More importantly, some tweets made @racewithinsulin never appeared @charliekmball. The most famous one being the branded Levemir ad: "Headed for Iowa Speedway. Just took Levemir®. For Levemir® (insulin detemir [rDNA origin] injection) prescribing info: http://is.gd/15uIl"

That was posted 1:54 PM Jun 18th. A few minutes earlier, at 12:47 PM Jun 18th @charliekimball posted "At LAX headed for Iowa. Ready for the race weekend." No mention of Levemir.

It appears that someone is selecting a sample of Charlie's authentic tweets made @charliekimball, editing them, and adding branded messages to them when necessary.

Is this any way for a pharma brand to carry on an authentic conversation?

Nasonex Bee May Usher In a Whole New Way to do FDA-friendly Pharma Tweets

Diabetes patient/racecar driver Charlie Kimball -- or his Novo Nordisk marketing handler(s) -- made the first ever pharma drug branded Tweet, which was offered up as a "model" for others to follow. I disagree (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!").

Whether or not Kimball's Tweet was "sleazy," "spam," "uninspiring," or something else, it will surely be followed by others. Hopefully, these others will learn from Novo Nordisk's experience.

However, there are other ways that pharmaceutical companies can leverage their brands' assets via Twitter. Rumor has it, for example, that the Nasonex bee character will start Tweeting like a little bird!

The beloved bee -- whose voiceover is said to be provided by actor Antonio Banderas -- is arguably the longest-lived drug brandname character/icon. Viewers of TV commercials such as the one below instantly associate the bee with Nasonex in focus groups.



If the bee rumor is true, it would represent a unique way of marketing Rx drugs via Twitter.

Instead of using real world highly-paid celebrities or patient advocates, who may stray from the script (see Andy Behrman, Now an Anti-BMS Spokesperson, Says "Ask Your Doctor If Abilify is Wrong for You"), using a drug icon like the bee avoids all this. Plus, there is no need to mention the drug name in Tweets made by the bee's agents (obviously, the mental link between the bee and the drug name is very strong).

Here are few of the topics that the Nasonex bee will Tweet about:
  • Updates on pollen counts with links to the "Pollen & Weather Forecast" on the Nasonex website,
  • Reviews of movies like The Secret Life of Bees,
  • Replies to Tweets made by Ronnie Nose -- another, lesser known and beloved, character -- with links to the "Don't Blow It!" game on the Nasonex site,
  • Humorous Tweets about the bee's love/hate relationships with pollen-coated flowers,
  • Bee trivia such as "How many bees does it take to make 1 pound of honey?" replies encouraged, and
  • Much, much, more...
Many drugs are likely to use the bee's Twitter account as a model for their own Twitter efforts -- even drugs that use real actors as characters in their DTC ads.

Abbott's anti-cholesterol drug Trilipix, for example, uses an actor who is a fashion photographer in its new DTC TV ads. This actor looks amazingly like the French actor Vincent Lindon (see "OMG! Worst Print Ad Ever! Plus: Is that French Actor Vincent Lindon?"). Having the character portrayed in the ad Tweet under a fictitious name -- eg, Vincent Trip, the fashion photographer -- would be very interesting. Vince can talk about his trade just as well as real-life Charlie Kimball does about his. Being totally ghost-written by Abbott agents, the Tweets can focus on cholesterol-lowering topics like what Vince had for breakfast that morning as he awoke next to the model he photographed the day before.

Unfortunately, Pfizer would not have much luck launching a Twitter account "written" by its latest Lipitor TV character "Steve" whose pathetic attempt at pathos and real life experience appears to be of little appeal or interest to viewers. Besides, Steve is a real person and as such cannot be trusted by Pfizer (or any other pharma company) to carry on a real conversation with consumers via social media.

Sunday, June 21, 2009

Pharma Marketers Should Stop Blaming the FDA for Their Dysfunctional Social Media Marketing Efforts

Last week I suggested that a Tweet supposedly made by diabetes patient/racecar driver Charlie Kimball was at best a "sleazy" reminder ad and, at worst, "spam' (meaning a product promotional message I never asked to receive). See "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!".

In a comment made to that post, Ross Fetterolf, VP Digital Strategy at Ignite Health, said "Yes, the post itself is a bit awkward, but it's hard to stay colloquial when a regulatory cloud surrounds this kind of communication; inclusion of the generic name and link to the PI were necessary for the tweet to even be possible." See comments to the post cited above.

Ross was not the first person to tell me how hard it is to create "colloquial" social media communications that aren't "awkward" because of FDA regulations.

Scott Docherty, from Procter & Gamble Pharmaceuticals, also defended his company's Asacol community for UC patients by invoking big bad FDA regulations: "With regard to the Community section, due to restrictions impacting the entire pharma industry for branded websites, we face challenges achieving the vision we have for this Asacol Community website." See comments to post "Proctor and Gamble's Dysfunctional Asacol Community for UC Patient."

In both cases, more blame can placed on the marketers themselves than on FDA.

In the Ascol community situation, I never raised one single issue that had anything whatsoever to do with FDA regulations. I cited a dysfunctional website that was giving users conflicting instructions of how to submit stories, having a voting system that did not count votes, and not allowing users to respond to stories submitted by others and carry on a conversation. The FDA does not care a fig about any of these things. P&G, I suspect is just concerned about receiving adverse event reports that it MAY have to submit to the FDA. That "regulatory problem" may already have by solved by UCB pharmaceuticals (see "Finally, a Drug Company Embraces Social Media, AEs Included!").

The Levemir Tweet, to me, just seems like a sleazy way of getting around FDA regulations just for the sake of mentioning the product name! It's not enough that the name is all over Kimball's race suit and car, he also has to mention it every once in a while in his Tweets?

This Tweet seems to have embarrassed at least one of Kimball's friends, who wrote this in personal communications to me:
"I happen to know Charlie ... I think he is a good guy and hate to see him hurt by this incident. I wonder if someone at Novo is adding in the marketing messages ... Charlie made a mistake by letting it go out. I just hope that the heat is directed at Novo instead of him."
You know something is wrong when you get unsolicited comments like that.

In my response to Fetterolf's comment regarding the Levemir Tweet, I said:
"Charlie Kimball's Tweets would be much more interesting if he stopped posting about cleaning his race suit, taking Levemir, etc, and told us a little bit about how he FEELs being a race car driver with diabetes, how he deals with the unique problems his medical condition gives him, etc. THAT would truly be inspirational!

"The real challenge for pharma marketers is to make a personal connections via social media, not to figure out how to get around regulations to promote brand name drugs.

"So my advice ... is to put away the branded hammer and take out the unbranded silk gloves."
There are a million ways you can use social media to promote your product and educate people about staying healthy without getting letters from the FDA (for a few ideas see "50 Ways to Use Social Media"). But seriously, if you need help and are not getting this from your current agency of record, you can give me a call at 215-504-4164 or drop me an email at johnmack@virsci.com and I will help you find another agency.

These three cases remind me of the Three Little Pigs children's story, which I adapted to create the following (click on the image to enlarge it):

The Three Big Pharma Companies & Social Media

Friday, June 19, 2009

Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!

Ross Fetterolf, VP Digital Strategy at Ignite Health, said yesterday was an "Historic Day" because "diabetes patient/racecar driver Charlie Kimball produced the first branded tweet on his Race With Insulin Twitter page (@racewithinsulin, http://twitter.com/racewithinsulin)" (see "A Historic Day: The First Branded Pharma Tweet").

Here's how the branded Tweet looks on Kimball's Twitter Web page:

(Click image for an enlarged, readable view.)

In this context -- the racewithinsulin Twitter Web page -- the branded Tweet appears on the same page that mentions the indication -- diabetes -- as well as the side effect, fair balance information; although the latter is written using a mouse-sized, barely readable text font.

However, most Twitter users -- about 67% according to my estimates -- do not use the Web to post or view Tweets. Most of us use third-party applications like Tweetie, TweetDeck, Nambu, and Twitterfeed to view and organize Tweets. The variety of ways by which Twitter can be accessed other than through the Web and cell phones is why the Iranian government has not been able to stop Iranians from using Twitter to reach out to the world.

None of these alternative Twitter access channels includes the background information found on the racewithinsulin Twitter profile page. On the right is what Kimball's branded Tweet looks like using TweetDeck.

Ross hopes this Tweet represents a "'safe' (and hopefully FDA friendly) approach." This prompted me to take a FDA inspector's view of the Tweet.

On first glance, this looks similar to the Google Adwords cited by FDA in the infamous 14 letters it sent to pharmaceutical companies back in April (see "The 14 Letters. Who at the FDA Knew What and When?").

The difference, however, is that this Tweet does not mention any benefits -- it's essentially what's called a reminder ad, which is not required to include side effect information because it does not mention any benefits. The FDA does not regulate reminder ads, and it is not likely to cite this Tweet as violative.

However, PhRMA's DTC Advertising Guiding Principles preclude this kind of ad on TV: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised."

Unfortunately, like the FDA, PhRMA has not gotten around to developing Guiding Principles for Social Media DTC Advertising.

A reminder ad of any sort -- whether in print, TV, Web, or Twitter -- is, IMHO, a form of spam. I consider, therefore, Kimball's unabashed product endorsement Tweet a particularly sleazy example of Twitter spam. We certainly do NOT want to see more Tweets like this and I disagree with Ross; I sincerely hope that this Tweet is NOT used as a "model" for other drug companies who want to adopt Twitter as a marketing vehicle.

P.S. Aside from the sleaze aspect, this promo missed an opportunity to educate readers about Levemir. Instead of linking to the product Web site, where you can find some useful information, it links directly to the PDF version of the package insert (PI), a technical document suitable for physicians but not for consumers, which comprise most of Kimball's "huge" audience of 128 followers, none of whom is likely to read the Tweet or the PI it links to!

Thursday, June 18, 2009

Procter and Gamble's Dysfunctional Asacol Community for UC Patients

Lately, my Twitter friends have alerted me to all sorts of examples of pharmaceutical companies delving into social media for marketing and corporate communications. I'd like to focus on just one example here: the Asacol Community for UC Patients. UC stands for ulcerative colitis - a form of inflammatory bowel disease. Asacol is a product marketed by Procter & Gamble (P&G) for the treatment of UC.

"In the Asacol Community, consumers are encouraged to provide stories or to ask questions," notes Ellen Hoenig Carlson in the AdvanceMarketWorx Blog (see "Pharma Marketers: Think You Can't Do Moderated Chat?"). "Content is carefully moderated per the guidelines, but consumers can rate and vote on story content and answers."

The Asacol Community reminds me of other efforts of pharmaceutical marketers to build "communities" within their product or disease awareness websites, YouTube, or FaceBook pages. They all share one thing in common: they are FAUX communities that have practically none of the characteristics of a REAL community. Although Ellen calls this a "chat," there is NO chatting going on. You can submit a story and that's about it.

Here's why this is NOT a real community and NOT a real chat:
  • You CANNOT submit a comment in response to a story,
  • Your "vote" as to whether or not the story was useful is NOT counted. No matter how many times I voted "No", the counter still said "28 of 32 people found this story helpful" (probably a made-up statistic), and
  • When I submitted a story, I was notified "If your story follows submission guidelines, it will be posted to the site within 3 business days." That turnaround time is not conducive to community-building.
Perhaps because of these reasons, there are only two (2) stories on the site that appear to have been submitted by visitors. But I suspect that these stories were plants written by P&G agents and not real people. In a real community or chat (see below), I could carry on a conversation with the person and find out if he or she is real or not.

A Dysfunctional Community
Not only can't I carry on a conversation with people posting stories to the Asacol UC Community, I cannot even have a meaningful conversation with P&G or Asacol via the "community."

When I submit a story, for example, I am not asked for my email address so that I can be notified if my story was accepted or not. That's just a common courtesy.

In fact, P&G is sending confusing messages regarding submission of email addresses. Does it want to collect email addresses or doesn't it?

The guidelines for story submission says "you shall not submit any content...that includes information that references...email addresses," among other things. Interestingly, however, the Terms & Conditions suggest that you can submit your email address with a story: "By submitting your email address in connection with your story, you agree that Asacol and its third party service providers may use your email address to contact you about the status of your story and other administrative purposes."

I'm totally confused by all this! Luckily, most consumers never read guidelines or Terms and Conditions as carefully as I do, otherwise they would realize how dysfunctional the Asacol Community for UC Patients really is.

A More Serious Problem
Aside from all this, I notice a peculiar problem with the story submission process, which is apparently provided by "Bazaarvoice, a company who provides a framework for capturing, managing, marketing and leveraging authentic user-generated content so that brands can capture and leverage their customer 'word of mouth' asset," according to Ellen.

When you submit a story, you can click on a "Helpful Tips" link next to the subject line. I am the sort of person who needs all the help he can get, so I clicked on it. The screen capture below reveals what I found.

(Click on image for an enlarged view.)

Although P&G's guidelines for submitting stories expressly prohibits mentioning product names, let alone benefits, the help message contradicts that warning and says that you have a better chance of getting your story published if you "Use the product before writing about it" and "Focus on the product's features and be specific."

This is obviously some kind of bizaare glitch in Bazaarvoice's software, which was obviously NOT modified appropriately for pharmaceutical company use.

P&G should thank me Profusely & Gratefully for pointing this out (I used to be a software tester and documentation expert; hire me next time before you launch a website!).

Aside from these "user-generated" stories, the Asacol site includes "Success Stories," which are obviously well-crafted stories written by P&G or its agents about seemingly real people. Links to these stories appear next to the link for "Shar[ing] Your Story," thereby giving visitors the impression that the "success stories" were submitted by people like them. Could be, I don't know. But have these people been compensated by P&G for use of their stories and images? From the Terms I guess that there is no compensation: "For any content that you submit, you grant Asacol a perpetual, irrevocable, royalty-free, transferable right and license to use, copy, modify, delete in its entirety, adapt, publish, translate, create derivative works from and/or sell and/or distribute such content and/or incorporate such content into any form, medium or technology throughout the world without compensation to you."

All these "stories," whether actually submitted by real people or not, contribute to a feeling of community on the site, but it is a faux and dysfunctional community at best. NOTE: I've written about faux pharma social media before (see "Faux Social Marketing: Have Your Cake and Eat It Too!").

What should a REAL UC Community look like?

I found one on the HealingWell.com site (see screen capture below). This is obviously a real, vibrant, and up-to-date community of people suffering from UC. There are hundreds of topics being discussed and also products by name. That, however, did not discourage Shire from advertising Lialda, its UC product, prominently on the site (although when you click on the ad, you are directed to a survey instead of the promised free trial!). I am sure that Shire gets much better ROI out of that one ad than P&G gets out of its UC "Community!"

(Click on image for an enlarged view.)

Wednesday, June 17, 2009

Should the Tax Deduction for DTC Advertising Expenses be Eliminated?

Rahm Emanuel, president Obama's Chief of Staff, warned advertising industry leaders some time ago that the business-tax deduction for DTC (direct-to-consumer) spending could be taken away in 2009 tax legislation (see "Obama, Democrat Win Could Cause Ad Industry 'Pain'").

Yesterday, Bloomberg.com quoted House Ways and Means Committee Chairman Charles Rangel as saying "one thing that's not off the table is you can pick up $37 billion knocking out the deduction for advertising" for prescription drugs (see "House Considering $37 Billion Drug Tax, Rangel Says"). He was suggesting this as one way to help pay for the pay for a health-care overhaul.

Where did Rangel come up with that $36 billion number? The US drug industry spends about $4.7 billion per year on DTC advertising. How can eliminating the business tax deduction on that expense yield an amount 7-8 TIMES that? I'm no accountant, so I need some help here.

UPDATE: A partial explanation was presented in a followup AdAge article:

"Mr. O'Brien [exec VP-director of government regulations for the American Association of Advertising Agencies] said the $37 billion would be spread out over the 10 years of funding the health-care reform bill, but still questioned the number. 'It comes out to $3.7 billion in taxes a year on advertising spending of about $5 billion a year -- that's steep even by Swedish standards.'" [See "Industry Mobilizes to Fight Off Congress' $37 Billion Ad Tax".]

The proposal is not to levy a NEW tax, but eliminate a tax break, a distinction that may be minor to many. Paying $3.7 bn on $5 bn of added income does seem very high and one wonders how even that number was calculated. I am sure the drug industry is NOT in the 75% tax bracket! Maybe 25% might be a better estimate. Therefore, by eliminating the tax break on $5 bn, the government is likely to gain only $1.25 bn per year or $12.5 bn over 10 years.

Meanwhile, 69% of respondents to the Pharma Marketing News Future of DTC Survey said "yes" (39%) or "maybe, it depends" (30%) when asked if the DTC business tax deduction should be eliminated (see chart). You can take this survey here and give you opinion about this and other issues that will have an imp[act on the future of DTC. Afterward, you can view a summary of the latest, de-identified results.

Finally, a Drug Company Embraces Social Media, AEs Included!

Adverse events! Adverse events! Adverse events!

How many times have you heard that tiresome phrase from pharmaceutical companies as an excuse for NOT embracing social media marketing?

Practically every social media endeavor that drug companies have engaged in has been a traditional one-sided affair: the drug company talks to the visitor, the visitor never talks to the drug company.

Even in so-called online "communities" sponsored by drug companies, there is very little community at all. A case in point is the UCB-sponsored Crohn's & Me website, which has been described as a "faux community" (see "Faux Social Marketing: Have Your Cake and Eat It Too!").

Crohn's & Me lacks the benefits of open-ended social networking.

The excuse, of course, is that onerous FDA adverse-event (AE) reporting requirements make it impossible for drug companies to sponsor or create truly open-ended social networking communities, even if they are not product related.

Social media advocates have long suggested that it is possible to handle any adverse events reported on pharma-sponsored sites, but no drug company was brave enough to be the first to try it -- until now!

Biopharma company UCB and PatientsLikeMe, an online community for people with life-changing conditions, yesterday announced a strategic partnership to create an online, open epilepsy community that captures real-world experiences of people living with epilepsy in the U.S.

According to the press release, this "platform," which is scheduled to launch in early 2010, is designed to collect, analyze and reflect information received from people with epilepsy, regardless of their diagnosis, prognosis or treatment regimen. That information specifically INCLUDES adverse events!

"PatientsLikeMe.com is working with UCB to create a pharmacovigilance platform that will monitor the site for adverse events," says MM&M (here), "utilizing 'a unique patient identifier,' and is looking to hire a full-time pharmacovigilance manager... Adverse events will be reported directly to the FDA...Only adverse events associated with UCB products will be reported to FDA, according to a UCB spokesperson."

Want to be a Pharmacovigilance Manager for an online community? Here are the responsibilities as posted by patientslikeme (see here):
  • Implement, and eventually direct the company’s pharmacovigilance processes, ensuring that SOPs, policies, guidelines, and working practices are current and reflective of current process, procedures and regulatory/legal obligations.
  • Learn and document the SOPs of our partner organizations and develop a portfolio of reporting levels for PatientsLikeMe
  • Ensure audit readiness in collaboration with partners, to include:
  • Support and assistance during regulatory/key customer inspections,
  • Consultancy assistance with inspection observation responses, and
  • Monitoring and follow-up closure of regulatory inspection/key customer corrective actions
  • Implement and oversee the company’s records management program for safety data.
  • Continue to upgrade our platform’s existing AE system to ensure reports are complete with minimal burden to our users.
  • Plan and execute the expansion of the Pharmacovigilance group including policies, staff selection, and training.
All it takes is money and one FTE to get around the adverse event reporting boogey man! (See "Report from CBI's eMarketing Forum: Taking on the AE Boogey Man").

Tuesday, June 16, 2009

OMG! Worst Print Ad Ever! Plus: Is that French Actor Vincent Lindon?

I just found this whole page ad for Trilipix in the June 22, 2009 issue of Newsweek magazine. It's got to be the worst DTC print ad I've ever seen! Here. Look at it! Don't you agree?

(Click image for an enlarged view.)

Abbott surely has gone overboard to make sure to balance benefit information with risk information.

I don't think the FDA had this in mind when it suggested in recent guidance that "As a general matter, risk and benefit information should be comparably noticeable or conspicuous in promotional pieces, and audiences should be able to read both risk and benefit information with similar ease" (see "Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance").

What we have here (in the Trilipix ad) is a failure to communicate anything at all! It's not that the risks aren't as EASY to read as the benefits; both the risk AND the benefits are DIFFICULT to read!

The only statement that stands out is "I didn't realize there was more to the picture than just bad cholesterol."

Speaking of "pictures," doesn't the grizzled and disheveled character in the ad look like the French actor Vincent Lindon who starred in the movie La Moustache, which I just saw on cable TV?!

That's Lindon on the left. Tell me that's not him also on the right (ie, guy in ad)!

Maybe this ad catches the attention of French movie buffs like me, but to Americans who don't know Lindon from Depardieu, I'm sure they pass it right by.

GSK, Sharing Miracles, Celebrities: Where's the Transparency?

I admit that I sometimes ask tough questions that takes my pharmaceutical friends a long time to answer. One such question involves GSK, PhRMA, and celebrities. My question is: Where's the transparency? (For a partial answer, please read through to the end for a follow-up.)

I would not have asked that question if GSK had not raised the issue itself in its More Than Medicine Blog (see "Patients, Celebrities and Pharma"). In that post "Michael F" recommends the Sharing Miracles website sponsored by PhRMA's Partnership for Prescription Assistance. It's "a forum for people to relate their own stories of hope and survival," according to Michael F.

On the site, you will read inspirational stories from Mike Ditka, Dominique Wilkins, Naomi Judd, Joey Pantoliano, etc.

Michael F also mentions that "GSK has joined with several notable personalities from entertainment and sports including a few who appear on the Sharing Miracles site...But these campaigns have to be handled appropriately--with full disclosure and transparency about our involvement [my emphasis] and in a way that adequately addresses the risks and benefits of medicines--or we risk losing the trust of the very people we're trying to reach."

But, when I went to the site, I could not find any disclosures relating to whether or not any of the celebrities were paid by PhRMA or any drug company or by GSK to tell their stories.

Did I miss something? Because I was looking for "full disclosure and transparency about [GSK's] involvement" and couldn't find it.

I posted that question to GSK's More Than Medicine Blog and am awaiting an answer.



Followup: Well I didn't have to wait for an answer as long as Adlai Stevenson did during the Cuban Missile crisis! Here's the response from Michael F (see his comments here):
"Thanks John. Yes, we worked with - and compensated - Jerome Bettis and Mike Ditka in the past on GSK programs. I'm not familiar with the terms of their (or any of the other celebrities) involvement in the PhRMA/PPA site, but will contact PhRMA to learn more."
Michael F did not mention Naomi Judd. In a previous post -- Country Music Superstar Judds Corner the Pharma Celebrity Market! -- I remarked that while Naomi Judd has a deal with PhRMA to appear on the Sharing Miracles site, her daughter, Wynonna Judd signed a deal with GSK to endorse Alli, the flagging weight loss OTC drug. Is this truly a coincidence or could it be that this is a mother-daughter/PhRMA-GSK collaborative deal? Mom could have brokered the deal by agreeing to appear on the PhRMA TV show if Wynonna got the alli gig, which may help her career.

Chris McDonald over at the Business of Ethics Blog picked up this story and says:
"And (as far as I can see) the site isn't promoting any particular pharmaceutical (or even pharmaceuticals in general, really). But then again, who knows what messages are buried in there? And why would anyone spend money to produce a site like this if they didn't think it promoted their interests? You would think that, in 2009, the pharmaceutical industry would be smart enough to know that it needs to be a little more transparent in its activities."
PhRMA guidelines regarding use of celebs states: "Where a DTC [Direct-to-Consumer] television or print advertisement features a celebrity endorser, the endorsements should accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies should maintain verification of the basis of any actual or implied endorsements made by the celebrity endorser in the DTC advertisement, including whether the endorser is or has been a user of the product if applicable."

The current PhRMA guidelines do not require drug companies to reveal that celebrities are compensated for their appearance in product ads and there are no guidelines for use of celebrities in disease-awareness campaigns where no products are mentioned.

So, I would say that industry-endorsed guidelines are more about translucency than about transparency.

Regulatory Ranters Miss the Point About FDA's Position on Search Engine Ads

An article in today's Washington Post -- "Drug Firms Jockey for Space Online" -- sent EyeonFDA blogger Mark Senak on a "fantastic rant" (HT @brianreid) against FDA's "fundamental lack of understanding of how people use the Internet for healthcare and therefore does not understand how to regulate it" (see "Fact or Fiction - FDA Has a Policy on Social Media?").

The question is: Is the FDA media agnostic or not?

"If drug companies or others working on behalf of drug companies wish to promote [their products] using social media tools, FDA would evaluate the resulting messages as to whether they comply with the applicable laws and regulations." said Karen Riley, a spokeswoman for the agency. "Our laws and regulations don't restrict the channels that prescription drug companies choose to use for disseminating product promotional messages."

"That is the same line they fed me during my podcast with DDMAC in March," said Senak, "which turned out to be inaccurate when they issued the 14 untitled letters on search engine ads. They are still sticking to their story - but take a whole dose of caveat emptor if you want to rely on it."

But I contend that the 14 letters do NOT contradict the line that FDA "fed" to Senak, who apparently got hooked.

Senak asks: "Does risk information need to be included in a search engine ad that names the drug and what it is for when the placement of the risk information is no differently handled than in a print ad?" Apparently, Senak believes a search engine Adword should be treated exactly the same as a print ad -- everyone knows you have to click the adword to see the risk information just like you have to turn the print page to see the full risk information.

But Senak misses an important point: the main promotional piece of a print ad -- what you see BEFORE you turn that page -- contains a "brief statement" about risks; Adwords don't.

FDA guidance on communicating risk says this:

"For a piece to be accurate and non-misleading, risk information should be included in the main part of a piece. If the omission of risk information in any part of a piece makes that part of the piece false or misleading, the problem cannot be corrected simply by including the risk information in a separate part of the piece [my emphasis]. To be comparably prominent to benefit information, risk information should generally appear in the same parts of the piece as the benefits."

You will note that the FDA does not say "print piece" and this example, which can equally apply to Adwords or display ads ("pieces") on the Internet.

In the post "Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance," I point out that you may not like that the FDA views an Adword as the "main piece" of a promotion, but there it is.

I agree, however, that the FDA should come out with SPECIFIC guidance for Internet ads just as it has done for TV and print. If the rules are the same, point that out with examples. Don't leave it up to imaginative marketers to interpret the tea leaves from "media agnostic" guidance.

Sunday, June 14, 2009

Shared Detail Appointments Can Save Doctors' Time & Improve Product Education

In the recent issue of the AARP Bulletin, I read about doctors scheduling appointments with up to 15 patients at the same time (see "Doctors Take Sharing to a New Level—Medical Appointments"). It's called a "Shared Medical Appointment."

"SMAs allow as many as 15 patients to schedule an appointment with one doctor for a 90-minute session. The physician interacts with individual patients as needed, but usually addresses questions with the entire group."

I'm sure the typical SMA session does not last 90 minutes. Thirty minutes would be about as long as I would want to sit in a group session! Therefore, I'm also sure it saves the physician a lot of time and needless repetition of the same information.

What if physicians applied the same idea to sales reps? That is, instead of seeing Jane who sells anticholesterol product A on Wednesday and Jake who sells anticholesterol product B on Thursday, why can't the doctor invite both Jane and Jake in for a visit at the same time? Have them make their best pitch and then allow a point-counterpoint discussion of features and benefits, comparing product A to product B.

I call this a Shared Detail Appointment (SDP).

What if, instead of sales reps, it were Medical Science Liaisons (MSLs)? MSLs aren't supposed to promote products but are peers who discuss the science behind products with physicians.

Not only would SDPs encourage head-to-head comparative studies, it would be great entertainment for the doctor(s). Of course, lunch should be included!

Friday, June 12, 2009

Missing FDA Letters Found. More Questions.

Last week I wondered why 5 warning letters citing violative paid search engine drug ads went missing and surmised that the FDA purposely retracted these letters because they revealed its ignorance of the Internet (see "Missing Warning Letters Prove that FDA is an Internet Dunce!").

As of 12-June-2009, the missing letters have been found and FDA's April 2009 list of warning letters now includes all 14 letters sent on April 2, 2009. See the list here.

Unlikely as it seems, it tuns out that the letters were somehow lost when the FDA's site was madeover/rebooted or whatever. Not only were the letters lost, they were not in the table listing all the April 2009 letters in the page cited above. Now that the letters are back and the table has been edited, you can find links to the letters and supporting documents.

Upon review of the missing letters, I do not find that the FDA mistook natural search results for paid ads as I thought might be the case. FDA may not, therefore, be as big a dunce as I thought! I apologize and am now "eating crow with hot sauce" as one commenter predicted I would. No matter, I am happy that I was instrumental in pointing out the problem to the FDA and in having the letters returned. It has also raised a few other issues I'd like to discuss.

Such as: if the site makeover was responsible for these letters going missing, what else is missing? "Too bad we [may never] know what else got lost in transition," was a comment I received from a friend.

One of the previously missing letters was sent to Sanofi-Aventis regarding a Plavix ad that appeared on Yahoo! "What's interesting," noted a Director of Search Engine Marketing at a major healthcare advertising agency, "[is] it actually talks about 'sponsored links' but references natural search engine results NOT paid search ads. Could it be a mistake since these are not sponsored ads and these results cannot be bought?"

Actually, the FDA did NOT make a mistake, whereas this search engine marketing expert DID! The ads CAN and WERE bought!

Let's look at the promotional material that the FDA included with the letter (see image below; click to enlarge; find the pdf file on the FDA site here -- I hope!).

The letter says that the materials were submitted for FDA review by sanofi-aventis U.S. LLC (Sanofi) "under cover of Form FDA-2253." FDA regulations require pharma companies to submit specimens of advertising devised for promotion of a prescription drug product at the time of initial publication of the advertisement. Sanofi, therefore, would NOT submit natural search results for review unless they were part of a paid program.

Actually, the Yahoo! Plavix ads cited by FDA are part of Yahoo’s “paid inclusion” program. According to Wikipedia: "Paid inclusion is a search engine marketing product where the search engine company charges fees related to inclusion of websites in their search index. Paid inclusion products are provided by most search engine companies, the most notable exception being Google."

If you look at the table above the ad, you'll see that Sanofi submitted what the "Pi Title Tag" should be, the keyword that triggers the ad to appear in the natural search results list, the URL the ad should link to, and the "Pi description" (what the ad should say, which violates the law according to the FDA). Thus, whenever the keyword "PAD Medication" was entered into the Yahoo! search engine, this paid ad -- exactly as Sanofi-Aventis specified -- would appear in the natural search results section.

I wrote about "paid inclusion" back in 2006 and pointed out that it is not a good search engine marketing technique for pharma to engage in, even if it passes FDA muster (see "Paid Inclusion: Too Hot for Pharma Marketing?"). Too bad, Sanofi-Aventis did not read that post.

Another interesting observation concerns the previously missing letter to Biogen Idec regarding it's paid search engine ad for Tysabri. The supporting promotional material that the FDA cited in its letter is dated "8/19/2008," seven and one-half months BEFORE the letter was sent to Biogen. Obviously, someone at the FDA was looking at these ads a long time ago. Could it be that the warning letter was delayed by Bush appointees at the FDA? I've pointed out before how top-down policy under the Bush administration was designed to delay the issuance of warning letters (see "FDA DTC Review: The House that Troy Built"). Now that there is a new administration, the warning letter floodgates are open, at least for letters already in process.

But has the process been sped up?

Although my original "missing letter" thesis -- that FDA hid the letters to cover up its ignorance of search engine marketing -- proved to be incorrect, I did learn a thing or two from this study that merits further discussion:
  1. PAID INCLUSION ADVERTISING. How frequently is it used? At least one pharmaceutical company has used "paid inclusion" to dupe consumers/physicians into believing that a paid ad was a natural search result. If this technique can fool experts, you can't blame consumers for also being fooled. This is important because many experts are defending paid search engine advertising as a way to offset other ways that consumers can be duped -- ie, by snake-oil salespeople. Do the ends justify the means? Also, how frequently is "paid inclusion" used by pharma marketers?

  2. It's taking the FDA way too long to issue warning letters. In 2007, it took the FDA an average of 6 months to issue a warning letter according to GAO. The Tysabri letter took over 7 months! That's simply too long. Any ad campaign, search engine or otherwise, would have run its course by then (see also "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!"). I believe that warning letters are being used to establish policy rather than to protect the public from false or misleading advertising. It's the latter goal that is important for protecting consumers, which is the mission of FDA. Clearly, FDA must issue these letters in a more timely fashion. And it certainly should not lose them -- even if temporarily -- once issued!

Is CME in the US Doomed? Or Just For-Profit MECC's?

"You know that CME [Continuing Medical Education] is in a bit of trouble when its longest-serving provider is hanging up its accreditation credentials and stepping out of the game," says James Chase, Editor of MM&M magazine (see "Credit where credit's due").

The "longest-serving provider" mentioned by Chase is Postgraduate Professional Services (PPS), which is a special kind of CME provider: a MECC, shorthand for Medical Education Communication Company. MECC's are independent profit-based companies many of which have been set up by advertising/marketing agencies. MECC's were a convenient way of establishing a "firewall" between the agency's promotional side and it's medical education side. OIG and ACCME demanded that pharmaceutical companies establish such "firewalls" between marketing and physician education.

MECC's are having a hard time and they blame it all on regulations such as the one I just cited.
“The CME enterprise has gotten bogged down in disputes, misconceptions and misguided regulatory initiatives,” charges Jon Bigelow, president and CEO of KnowledgePoint360, which owns PPS. “Many of pharma's critics have gone to illogical extremes that will hurt the healthcare system and patient care. In this environment, neither supporters nor providers can plan effective activities to meet the long-term needs of busy practitioners.”
Will the healthcare system in the US be "hurt" if all for-profit CME providers went out of business?

To answer that question, I accessed a survey that Chase cited in his editorial: the 2008 AAMC/SACME Harrison survey. One of the survey's conclusions was that 121 out of 145 commercially-supported (ie, pharma-supported) CME activities offered by the average medical school would not have been offered without this support. The average school offered 147 CME courses, which means that 99% (145/147) of medical school CME courses are commercially supported. In fact, 54% of the revenue for academic CME in the US comes from commercial support.

The situation is different in Canada. There, only 14% of academic CME revenue comes from commercial sources (see chart; click on it for an enlarged view).


I don't see how Canadian healthcare has been hurt by this lack of commercial revenue for academic CME.

But MECC's, which are in competition with medical schools that have their own CME departments, are being hurt. Perhaps most MECC's can go out of business and it would not affect the academic CME community much. [The mean pay for an academic Director of CME in the US is $80,000, according to survey cited above. At that salary level, academic CME departments probably would have no problem hiring out-of-work MECC personnel.]

Not too long ago, Pfizer announced that it will no longer directly fund CME courses provided by for-profit, third-party companies (ie, MECC's) although it will keep paying for courses offered by med schools, teaching hospitals and medical societies (see "Pfizer to stop funding for-profit CME").

That's when PPS's fate was sealed. According to KnowledgePoint360 Group/PPS's LinkedIn page, the company's employees are well connected to Pfizer! Maybe, too well-connected I would say.

Whether or not bypassing MECC's will eliminate bias in commercially-supported CME is open for debate. The following are some comments about Pfizer's decision received so far from the ongoing survey: "What's the Best Way for Pharma to Sponsor CME?"

What's the Best Way for Pharma to Sponsor CME?
[I invite you to take that survey here. Afterwards, you will be able to see a summary of the de-identified results to date.]

Some comments from survey respondents:
"Maybe Pfizer was working with the wrong for-profit, third-party company [JM: PPS?]. There are a lot of honest for-profit, third-party companies. I find that most pharmaceuticals reps focus on sales and are not aware of the guidelines or do not know how to set boundries. As a MECC I inform them of the guidelines and I work at keeping informed i.e. OIG, FDA, ACCME, Stark Laws etc etc etc. It's a job just trying to interpret all those requirements and then try to figure out the pharma's own internal guidelines. Does it really matter where the money goes if spot checks are not done to determine if a CME provider is including marketing with educational materials i.e. print material that are the same color as the product packaging etc. I think that ACCME should include some marketing people in there site visits."

"It's probably easier for Pfizer to use this model because the for-profit, third party companies are the gray area. However if the argument is that courses paid by the pharma industry are biased simply because they are company funded courses, then it really doesn't matter if a med school, teaching hospital or medical society provides the eduction. They would be inherently biases because of the funding. Non-profit does NOT equal unbiased."

"I don't see any evidence that med schools and societies are any less biased or less beholden to pharma dollars."

"The Pfizer response is a last resort. Medical societies and med schools are motivated by revenue streams to a significant degree and will be subject to significant influence once the magnitude of funding and competition for these unrestricted grants increases. In addition, med schools and societies are not currently capable of providing an adequate volume of CME courses/materials to satisfy the current need. It will take several years to build up capability. Once an institution makes a significant investment in staff and infrastructure, the need to continue to attract large amounts of grant money to support the CME operation will create the a real potential for programs that are not completely independent. In addition, societies and medical schools have complex relationships with pharmaceutical companies since they partner in both clinical and preclinical studies. These relationships could result in unintended influence on CME programs. Until the learner drives the financial process, truly independent CME will not be achieved. Since physicians are often reluctant to finance their own education, perhaps pharmaceutical companies could (as a group) fund a large independent foundation that could provide financial "assistance" equally to all physicians who could then individually choose (and pay for) courses and materials based on content and quality. This would encourage physicians to participate in CME programs while preserving the competition between commercial CME providers that drives innovation and quality and removes pharma funding from the provider side of the equation."

"Since MECCs are in the business of CME, they often are the most up to date on changes and have greater resources to ensure that programs are in compliance. Med Schools, etc. often have only one small office which manages hundreds of programs per year which cannot keep up with industry best practices, etc."

Thursday, June 11, 2009

Internet Advertising Has Stopped Dead in Its Tracks!

As reported by eMarketer, "according to the Interactive Advertising Bureau (IAB) and PricewaterhouseCoopers (PwC), total online advertising revenues in Q1 2009 fell to $5.48 billion, down 10% from the previous quarter and down 5% from Q1 2008" (see "Internet Advertising Revenues at $5.5 Billion in Q1 ’09" and chart below).

This downturn was a "surprise" to eMarketer, which said "many pundits thought that digital advertising would not dip into negative growth because it was less expensive and offered more measurability than traditional media channels" (see "Surprise: Online Advertising Down").

Perhaps the 2008 fourth quarter uptick caused these pundits to believe that the trend would continue into 2009. It's more likely that that increase was due to the "spend it or lose it" syndrome; ie, spend what's in the budget so that next year's budget won't be adjusted downward to reflect what was spent in the previous year. I suspect that the 2009 budgets of online advertisers have been cut back anyway and this is why there was such a sharp decline in the first quarter. It's likely the decline will continue in the second quarter and perhaps move up a bit in the 3rd and 4th, but nowhere near enough to make 2009 a better year than 2008 overall.

Why all the surprise? Didn't eMarketer report that search engine marketing was down 11.5% in the first quarter of 2009? Based in that data I said "I doubt that 2009 will see an overall increase in pharma ad spending online"(see "Online Advertising Growth Slows in 2008, Search Declines in 2009").

If you're in the business of online advertising, you don't need an eMarketer or IAB to know which way the wind is blowing. It ain't blowing at all!

Wednesday, June 10, 2009

Missing Warning Letters Prove that FDA is an Internet Dunce!

UPDATE: See "Missing FDA Letters Found. More Questions."

On April 2, 2009, FDA's DDMAC sent 14 warning letters to 14 different pharmaceutical companies regarding sponsored search engine ads that it said violated FDA regulations regarding presentation of fair balance (see "FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!").

The 14 companies receiving these letters were:
  1. Biogen Idec
  2. Cephalon
  3. Forest Laboratories
  4. GlaxoSmithKline
  5. Sanofi-Aventis US
  6. Bayer Healthcare Pharmaceuticals
  7. Johnson & Johnson Pharmaceutical Services
  8. Pfizer
  9. Novartis Pharmaceuticals
  10. Genentech
  11. Boehringer Ingelheim Pharmaceuticals
  12. Merck & Co
  13. Eli Lilly and Co
  14. Hoffman-LaRoche
Today, you will find only 9 letters on the FDA's Website (here). The letters sent to the first 5 companies on the list are gone and not to be found. It's not just that these letters were removed from the warning letter list, the letters are gone altogether.

In the post I cited above I provided a link to the Biogen Idec warning letter: ie, http://www.fda.gov/cder/warn/2009/Biogen 20Letter.pdf, which now leads to a "Page Not Found" error.

Fortunately, I saved the letter that was sent to Sanofi-Aventis US -- find it here -- plus the promo material -- find it here -- that shows the violative ad discussed in the letter.

What happened to these 2 and the other 3 missing letters?

A Director of Search Engine Marketing at a major healthcare advertising agency, in a comment posted to another blog, suggested that the Yahoo! Plavix "sponsored ads" cited by the FDA were not paid ads: "What's interesting is the FDA letter to Sanofi about Plavix. It actually talks about 'sponsored links' but references natural search engine results NOT paid search ads. Could it be a mistake since these are not sponsored ads and these results cannot be bought?"

UPDATE: See "Missing FDA Letters Found. More Questions."

P.S. Some people attribute the missing letters to recent changes FDA made to its web site; ie, to broken links (see comments). However, there are NO broken links! The links simply are no longer there within the April 2009 section of the web page, whereas they were there previously. Whole rows in the table are missing. This means that the page was edited manually to REMOVE those links. I note that the page was edited on 6/8/2009.

For the record, I captured the Warning Letters page directly from the FDA website on 11-June-2009. You can find the pdf file here.

According to Mark Senak at EyeOnFDA, "I've never seen a retracted [FDA] letter." Well, of course! You cannot see it once it's been retracted! But I know what you mean, Mark. This does not bode well for FDA's new transparency initiative!

P.P.S. Crystal Rice from the FDA's trade media office returned my call and tried to explain why the 5 letters were no longer on the FDA site. You can listen to that conversation here. Afterward, via email Ms. Rice said: "I have confirmed with DDMAC that the five company letters you inquired about were not retracted. They were inadvertently dropped off the site during the recent FDA website migration. The web team is working to repost them as soon as possible."

I understand how some files (eg, warning letters) can be inadvertently "dropped" when migrating a web site, but how does a table on an HTML page mysteriously lose 5 rows? When you "migrate" you move the whole page, you do not edit the contents of the page except perhaps for navigation links.

To believe the "migration ate the 5 letters" excuse, you would have to believe that not only did the letters (ie, PDF files) go missing, but simultaneously, the rows in the table containing the links to these letters also went missing. Seems more like a deliberate edit job than a "migration" mishap!

For now I will suspend my disbelief and wait and see if the five letters are returned.

UPDATE: See "Missing FDA Letters Found. More Questions."
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