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.

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.

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).

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.

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.

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):

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!

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.)

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").

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.

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!

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?"


[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."

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!

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."

Weight Loss Drug Alli on Life Support. GSK Picks New Agency to Oversee Its Eventual Death

A new ad agency -- TBWA -- won GSK's weight loss alli account last week according to a recent Advertising Age article (“Side Effects of TBWA Win Include Unpleasant Alli Account”). If its efforts to save alli via a new advertising campaign fails, alli could be on “life support within 12 months,” says a marketing executive quoted in the article.

But alli is already on life support! It's more likely to be dead in a couple of months.

The first sign of trouble was when the alli blog (alliconnect) went silent back in September, 2008 (see "Has the alliconnect Blog Been Abandoned?"). Just prior to that Steve Burton -- who is credited with launching alliconnect -- was replaced by Karen Scollick as Vice President for US Weight Control at GSK (see "New Image for alliconnect Blog: Skinny Women"). These warning signs predated the reported review in February by GSK of Havas' Arnold, the agency that was handling the alli account at that time.

US sales of alli were down 53% in 2008 to $131 million according to AdAge. It’s market share for weight-control tablets is down 7% in the most recent 52 weeks compared to the year before.

AdAdge also reported that GSK spent $95.6 million in measured media spending in 2008. That does not include the alli blog and search engine marketing (SEM), which could be as much as 40% of all ad spending. That means GSK could have spent $159 million to advertise and market alli in 2008 to achieve that $131 million in sales – a negative ROI. In comparison, 2007 was a much better year: GSK spent $88.6 million in measured media ads ($147.6 million, if you include the blog plus SEM), while sales of alli were $247.2 million.

Bad marketing, however, is not to blame according to the AdAge article. "Keri Gans, a registered dietitian and spokeswoman for the American Dietetic Association, which partners with GSK to promote healthful eating and working with a registered dietitian, doesn't fault the marketing," says AdAge. It's the consumer's fault for not following the healthy living directions included in the marketing. Perhaps the marketing was TOO effective in that regard: it may be that people followed the advice about healthy living, stopped paying through the nose for alli, and lost weight; ie, you can lose the weight WITHOUT alli! That could explain why sales in 2008 tanked after a good initial year in 2007.

Let's Make it a Threesome: One Other Social Media Activity Pharma Can Do Now!

Two other pharma "wise men," ie, my Twitter and Blogger friends Jonathan Richman (Dose of Digital) and Fard Johnmar (HealthcareVox), have suggested ways that pharmaceutical companies should be using social/digital media today.

Jonathan suggested 10 marketing tactics ("Ten Digital Marketing Ideas Pharma Companies Will Never Try (But Should)") and Fard suggested 4 strategies rather than tactics ("A Counterproposal: Four Digital Activities Pharma Companies MUST Engage In Now Or Next Year"). Both have some excellent ideas.

In the spirit of Twitter, ie, "less is more," I would like to suggest one specific social media activity/tactic that can be part of Fard's second strategy, which is:

"Decide whether using a specific social technology is worth the effort – i.e., is it truly a good fit for the company? And, if the answer is yes, commit to building relationships with stakeholders using these tools over the long term rather than on a year-to-year basis."

Note that this strategy is NOT applicable to brand silos within pharmaceutical companies. Brand managers are NOT long-term thinkers. They care FIRST about what's good for the brand and SECOND about what's good for the company. That is, they are not thinking "how can I increase my company's awareness among consumers and investors?"

Also, each brand has different stakeholders -- not all patients and physicians are alike in what they need from a brand. Do they even want a "relationship" with a brand? I, for one, have no need for a relationship with Lipitor! I want a relationship with a company, which consists of people. To me, a brand is not people.

Since social media is all about people, it may not be appropriate for brands to use social media to build relationships through those channels. But, a company can!

On the one hand, at least one pharma corporate blog -- JNJBTW -- has been around for a long time (ie, on a "year-to-year" basis).

On the other hand, we've seen at least 2 pharma blogs that have gone dark in the past year or so: AlliConnect and CNTO411. These were not corporate blogs; the former was product-specific and the latter was therapeutic-specific. (BTW, CNTO411 might just be reborn as a true corporate blog.)

I predict that by the end of 2010, practically every major pharmaceutical company will have a corporate blog and practically none of them will have a drug brand blog.

So the one strategy I recommend for every pharmaceutical company is to launch a corporate blog whose goal is to build a relationship with people (aka, "stakeholders") and improve that relationship over time.

One specific idea came to mind during a recent conversation with a senior director in charge of his company's wellness initiative. One of his goals is to help any patient or physician find patient assistance programs whether the program is offered by his company, by a coalition of companies or by a competitor company. He also keeps track of health reform issues, laws, etc, in the news and publishes an internal newsletter in which he summarizes the news he believes is most important for his company to learn about.

I suggested that this director start up a blog where he publishes his summaries of health reform news and also highlights various aspects of his company's wellness program. The two are tied: readers of his health reform news aggregation/commentary may submit comments asking about how they can get help obtaining free or discounted medicines. In replies, he can guide people to the appropriate areas of the wellness website he also maintains.

All pharmaceutical companies that have Patient Assistance Programs (PAPs) should start up blogs like the one I suggest. It's all well and good to send out a press release announcing your assistance program, but it is necessary to follow-up with a long-term commitment, especially when we are in the midst of a long-term recession. Your stakeholders are going to want to know what you are doing now, not what you have announced last week.

P.S. This represents my further thoughts on the subject of corporate blogs. Previously, I suggested that "Corporate Blog" is an Oxymoron and I cited CNTO411 as the prime example. I still believe a blog must have a personal voice rather than a corporate voice. CNTO411 had such a voice, but since it was focused on one therapeutic area, there was no long-term strategy when the brand related to that therapy took on a different leadership or whatever. A blog like JNJBTW also has a personal voice (Marc Monseau), but it obviously was built with a long-term strategy in mind and will survive when Marc eventually moves on to other things.

The type of blog I suggested above should also have a personal voice -- the person who is most passionate about the subject and who is charged with helping patients. But it also follows Fard's wise advice: it's a good fit for the company and there is a long-term commitment.

The DTC Media Machine is Struggling

I asked Dale Taylor, the President and CEO of AbelsonTaylor, the "world’s largest independent medical advertising agency," the following question via Med Ad News's Ask the Expert page:

“The majority of respondents to my ‘Future of DTC Advertising’ survey expect DTC ad spending to decrease in 2009 compared to 2008, which saw an 18% decrease compared to 2007. What do you think and why? What brands or categories do you think will show an increase in DTC spend in 2009?"

In his response, Dale said:

"Somewhere we got the idea that aggregating the opinions of people who don’t know what the future holds can provide a clear picture of what the future holds... I don’t really know what difference it makes anyway except, maybe to Rupert Murdock."

Well, the publisher of Med Ad News is no Rupert Murdock, but opinions of people do seem to make a difference to that publication, which made a big deal out of a survey of 104 of its subscribers in the lead article of this month's issue ("Traditional media is alive and well (for now)").

Unfortunately, although Med Ad News said the study showed an "increased number of marketing professionals [who] indicated that their DTC budget for 2009 has decreased," they gave no details such as percentage of the 104 who said that nor how much their budgets decreased.

Meanwhile, the following chart (click for an enlarged view) shows the results so far of the survey of Pharma Marketing News/Blog readers (N=65):

Of course, this is not a scientific study and the respondents probably do not include many product managers who would know something about actual budgets, but there's a certain amount of wisdom in this crowd, despite what Dale Taylor thinks. (You can take the survey and add your wisdom here.)

IN FACT, there's QUITE a bit of wisdom in this crowd. According to a study by Cegedim Dendrite, the percentage of marketers who say they will decrease their DTC spending rose to 58% in 2009, up from 28% in 2008. If you add up the percentages in my survey chart the result is 59%, which is about as close to Dendrite's 58% as you can get!

"The decrease in spending would be due to budget cuts and a shift to more targeted direct-to-patient efforts," says eMarketer (see Drug Marketing Drops).

Dale agrees: "I am, however, confident that many brands will be doing a lot more with a little less when they start making their DTC communications more targeted, more insightful, more creative, and less dull. Relentless pressure to improve ROI will make this inevitable."

What's the goal of DTC spending anyway?

I only ask that question because of a disturbing remark made by an expert quoted in the Med Ad News article I mentioned above: "A critical mass of new patients is obviously needed to keep the media machine going. If a media budget is too low, or target audience too small, it may be extremely challenging to keep the media wheels greased."

To this person, DTC budgets are just grease for the wheels of the marketing machine. Marketing for marketing's sake!

This is what happens when there's too much focus on dollars and cents ROI.

Thank You Johnson & Johnson for Dinner

Yes, despite my past misgivings about Bloggers Dining at Pharma's Table, I accepted an invitation from Rob Halper (responsible for JNJHealth, J&J's YouTube page) and Marc Monseau (blogger at JNJBTW Blog) to dinner at Piano Due in NYC.

The purpose of this dinner was to discuss the shifting landscape of healthcare 2.0, an informal discussion about social media and the healthcare industry.

Thank you J&J for a great dinner! I enjoyed meeting up with "old" friends and making new friends as well.

I think my end of the table had the best discussion going! ;-) Although Marc and Rob strategically placed themselves midstream, I'm afraid they may not have been able to hear and take in any learnings available from either end. So let me summarize our discussion:

(1) Some of my physician friends at the table were very concerned about misinformation that consumers/patients may post on SM sites (eg, discussion boards). And how small, vocal groups, can come to dominate Google searches making their views seem to have more appeal than their numbers warrant. That's the problem with "wisdom of crowds" -- depends on how you define crowd (see, for example, "The Problem with Social Networks: Where's the Wisdom in 1% of a Crowd?")

(2) For patients, the best, safest, and most accurate health information is available through social media (eg, discussion boards, blogs) that are populated by a variety of stakeholders: patients, physicians, caregivers, etc. I would add to that pharma companies as well, but we did not discuss how this could happen.

On my way home accompanied by Andrew (another J&J employee), I suggested that if he were to start a blog the best way to promote what he is doing is via direct response to comments submitted; ie, speak up only when asked.

This would work with discussions not involving specific products (Andrew's content concerns health reform issues and wellness/patient assistance programs).

(3) Google is the online equivalent to Oprah Winfrey! This brings me back to (1). Oprah is just one person, yet her views influence millions. If it's OK for TV -- and maybe it's not (see "Who's the Quackadoo? Oprah or Dr. Oz?") -- then it's OK for online as well; "same rules apply" as the FDA would say.

Full disclosure: I do not do any consulting or other paid work for J&J. J&J paid for the dinner, but I paid all my travel expenses to get there.

Marc, please name a charity that is important to J&J employees and I will donate $50 to it. I know it may not cover the entire cost of my dinner, but it's all I can afford right now. Seeing from your blog what some J&J people volunteer to do makes me ashamed of not giving enough myself to charitable causes. Thanks for the opportunity.

P.S. The photo displayed in this post was NOT taken at last night's dinner! It's a pic from some other (non J&J) dinner that I did not attend.

Pristiq DTC Campaign Challenged to Concisely Communicate Risk

Almost one-half of Wyeth's new Pristiq print DTC ad creative, which I cut out from this week's Newsweek magazine (see left), is devoted to presenting risk information, including a black box warning about suicide risk that FDA now requires for all antidepressant drugs (see here).

The TV ad debuted last night during the depressing show Earth 2100 on ABC (see here). I would estimate that 30 seconds of the 60-second TV ad is also devoted to presenting risk information (find the TV ad on the Pristiq website here).

Now I could write about the wind-up doll analogy, but that would just be a cheap shot. Like, whoever remembers such antiques?

According to a confidential inside source, the wind-up doll signifies what many people on depression feel like: they must go through their daily lives on “autopilot,” and at times, do not even “feel human.” The wind-up doll simulates the impact of depression on daily functioning -- particularly feelings of sadness, loss of interest in favorite activities, trouble concentrating and lack of energy. OK, I'll buy that.

I'm more interested in the fact that despite the dire warnings required, Wyeth decided to do a DTC campaign at all! A black box warning in the past spelled the death knell for DTC advertising. Literally half of the Pristiq TV media spend is going towards risk communication!

If the risk segment of the ad were creatively done to make the risks (including death) sound reasonable (as in recent Celebrex TV ads), then I would say the money was well spent. However, the Pristiq TV ad uses a conventional voiceover technique citing a laundry list of bad things that can happen to you. While the voice drones on, the video shows the patient enjoying a nice, happy, family outing. Also, the music is more lively during the voiceover.

Which makes me think: Did this ad pass muster with the FDA? I only ask that question because of the recent publication of FDA's draft "Guidance for Industry on Presenting Risk Information in Prescription Drug and Medical Device Promotion" (see "Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance").

I worry that the Wyeth marketing people did not read this FDA document carefully (actually, I'm sure the ad was created long before the document was released). I draw their attention to Example 20 on page 20 of the FDA draft Guidance:

"Example 20: A video or broadcast ad depicts a joyous or exhilarating moment, contains images of people enjoying the benefits of the product, or includes otherwise compelling or distracting non risk related images while major risks are communicated in a voiceover. The inconsistent tone or images may be too distracting for the audience to listen to or process the risks, causing the video or broadcast ad to communicate a false or misleading net impression of the product."

This describes exactly the Pristiq technique of presenting risk information and I must admit that I did not absorb it all as I was looking at all the nice people and listening to the soothing music.

I'm sure the FDA will send Wyeth a letter about this, probably next year around this time. So, you better look out Wyeth! The bad FDA has you in its sights!

This is an interesting case not just because of the way risk information is presented in the TV ad, but because there is a campaign going on to eliminate the requirement for a suicide black box warning for anti-depressants not intended for children (Pristiq is indicated only for use in adults). As I wrote about a few days ago, some mental health professionals think the FDA should change its policy regarding the safety of antidepressants (see "Unintended Consequences of FDA Warnings: Lilly-funded Antidepressant Case Study").

Again, given how long it takes the FDA to enforce or change regulations, I don't expect Pristiq to benefit from the anti-black box campaign any time soon. Wyeth, however, should modify how the risk information is presented in light of the draft guidance, IMHO.

Comments from Wyeth were not available at the time of publication of this post, but I hope to speak with a representative later today and report back.

Meanwhile, here are some comments about the Pristiq TV ad gleaned from Twitter:

"Is the best ad campaign platform for Pristiq--an antidepressant drug--really a homely woman staring blankly at an expressionless doll?" @TheNapkin

"OH on prescription anti-depressant commercial: "Pristiq is THOUGHT to work by..." What? You mean you don't know?! Frightening." @luna_x

"interesting, seeing a commercial for pristiq & they just said that "it's thought that pristiq works by..." shouldn't they know how it works?" @lbbinc

"Hey Pristiq - what's the point of being an anti-depressant if your side effects increase suicidal thoughts? ...seriously, I'm asking!" @Matticus44

"Ahhhh Pristiq commercial. Guess I'll go on that tomorrow since I'll be so depressed after this show, ha #Earth2100" @prettyannoyed

Who's the Quackadoo? Oprah or Dr. Oz?

This morning I was treated to a confluence of stories that intertwine in interesting ways -- something that always prompts me to point out the links between seemingly disparate sources of information.

I read the first story in the June 8, 2009, issue of Newsweek during breakfast this morning: "Crazy Talk. Oprah, Wacky Cures & You."

Wow Oh Wow! A critique of Oprah Winfrey! On the front cover of a national news magazine! Can you get any more cheeky than that? And I thought I got hate mail when I was critical of Sally Field for being a mouthpiece for Boniva (see "Web 2.0 Hates Sally").

"Wish Away Cancer! Get A Lunchtime Face-Lift! Eradicate Autism! Turn Back The Clock! Thin Your Thighs! Cure Menopause! Harness Positive Energy! Erase Wrinkles! Banish Obesity! Live Your Best Life Ever!" proclaims the subtitle of the Newsweek article. These are all claims made by Oprah and/or her TV guests like wacky Suzanne Somers who injects estrogen directly into her vagina (yech!) and claims her unregulated "bioidentical" hormones are risk free!

"Many people write Suzanne off as a quackadoo," says Oprah. Not Oprah. "But she just might be a pioneer." Yeah, pioneer like Jebediah Springfield in an episode of The Simpsons!

The Newsweek article goes on to recount many instances where Oprah seems to endorse wacky ideas on her show and gives the last word to individuals who have a different sense of what is and what is not science.

For example, Jenny McCarthy -- like Suzanne Somers, another erstwhile Playboy model -- was a guest in 2007. McCarthy blames the MMR vaccination for her son's autism, a claim often disputed by the CDC. While a doctor from the audience pointed out the lack of scientific evidence connecting vaccination with autism, Oprah gave McCarthy the last word, which was "My science is named Evan, and he's home. That's my science!"

Anecdotal evidence and personal experience -- especially of celebs -- is Oprah's forte. It's also the forte of celebrity endorsements paid for by the pharmaceutical industry (see, for example, "Will Latisse Turn Brooke Shields' Blue Eyes Brown?").

The other story I cam across this morning concerned Mehmet Oz MD (Dr. Oz) who makes frequent appearances on Oprah and has the line of best selling books You A User’s Manual, says J Douglas Bremner on his Before Your Take That Pill Blog (see "America’s Doctor Back Peddling More Goods: Have Some Resveratrol").

Bremner's beef with Dr. Oz is that he is a shill for the pharmaceutical industry (see "Online Age Quiz Is a Window for Drug Makers"). I have commented on this previously (see here). RealAge was also featured in a recent post by Jonathan Richman on his Dose of Digital Blog (see "RealAge, Wii Fit, and Pharma Marketing").

"It is bad enough when he [Oz] is cheering for drugs that might work sometimes, in some people," says Bremner. "But now he is blowing his bully horn for complete rubbish. Namely, resveratrol. A supplement that originally came from wine skins that is now being touted as the cause of the 'French paradox' and which can cure cancer and extend your life... America’s quack now tells us that taking resveratrol can prolong your life based on studies in animals that it extends life by 35%. 'Don’t you want to live to be 125?' he croons."

At least Somers is less grandiose in her aspirations for long life. "I know I look like some kind of freak and fanatic," she said. "But I want to be there until I'm 110, and I'm going to do what I have to do to get there." Hasn't she tried resveratrol yet? Why settle to live to just 110 when you can go all the way to 125?!

Newsweek's Oprah story also featured Dr. Oz, but mostly in a favorable light. While other Oprah guests "gush nonsense," say the authors, "Some of the many experts who cross her stage offer interesting and useful information (props to you, Dr. Oz). Oz, fit and handsome, is particularly good at connecting with Oprah's audience. He is a cardiac surgeon at Columbia University and generally sticks to the facts."

Dr. Oz, however, does not always to stand up for science and use "facts" to dispute the questionable claims made by other "experts."

"Oz isn't without his faults," say the Newsweek authors. "He sometimes keeps quiet on the show when Oprah's out-there experts are spouting their questionable theories. There seems to be an unwritten rule that one Oprah expert may not criticize or correct another, and Oz has an interest in keeping Oprah happy. She has turned his books into mega-bestsellers, and features him on her Web site and in her magazine."

So who's the biggest quackadoo? Oprah or Oz? You tell me.

The Vendor Client relationship - in real world situations

Let's try a few of these and see how far we get in the real world:

Unintended Consequences of FDA Warnings: Lilly-funded Antidepressant Case Study

There's been a lot of angst over an increase in FDA enforcement letters and the effect they might have on the bottom line. Mostly, however, all the angst comes from agencies and channels that lose advertising revenue as a result. The sales and stock prices of companies receiving such letters are not much affected (see "Ramifications of FDA Regulatory Actions"; PMN Reprint #85-02).

FDA warnings of risks associated with a drug or a class of drugs, however, can have a much more dramatic effect on diagnoses and related pharmaceutical sales as a recent study regarding depression diagnoses shows. Here's how this study -- published today in the Archives of General Psychiatry -- was summarized in the LA Times this morning (see "FDA warning on antidepressants have depressed depression diagnoses"):

"After five years of steady growth, diagnoses of depression in patients of all ages dropped like a rock in 2004, the year after the Food and Drug Administration warned that the current generation of antidepressant medications increased the risk of suicide and suicidal thinking in children."

Although by 2007 "depression diagnoses had begun creeping back up.. physicians were still less inclined than they had been before the FDA's warning to diagnose a patient of any age with depression and to offer medication."

"The study is the latest to suggest that the FDA's warning -- and the media coverage surrounding the issue of SSRIs and suicide -- have set back progress in treating depression, a condition that the mental health profession believes is seriously underdiagnosed."

Considering that many people think that the "mental health profession" is practically in bed with pharmaceutical companies and is responsible for OVERdiagnosing depression -- especially in children -- this "drop like a rock" decline better be described as a "correction."

Figure 1 from the study -- shown above -- does show the dropoff in new diagnoses, but I would hardly characterize it as "dropped like a stone," which would be a more apt description of my recent 401K valuation, which makes ME very depressed.

The study authors draw two conclusions from the data:

• Observed diagnosis rates were significantly lower than history predicted based on the preadvisory trend, and
• the spillovers to adults in the general medical and specialty managed care enrollee population have persisted

The spillover to adults is one "unintended effect" of FDA's regulatory action, claim the authors.

The authors hint at another "unintended effect": an apparent increase (or lack of decrease) in suicide rates for youth aged 10 to 19 years.

The third "unintended effect" cited by the authors is the cost to society due to loss of employee productivity caused by depression -- saying it could outpace the $152 billion economic stimulus package passed in early 2008.

Meanwhile, the 10% to 15% drop in prescriptions written for for SSRI anti-depressant drugs -- an "expected consequence" -- after FDA's warnings "were smaller than reported earlier," noted the authors.

The authors end by suggesting that their study presents "evidence of substantial, persistent, and diffuse unintended effects," which the FDA should consider. In their opinion, FDA should change its policy regarding the safety of antidepressants.

Oh yeah, Drs Libby, Orton, and Valuck (study co-authors) report "unrestricted investigator-initiated research grants from Eli Lilly and Company and Forest Pharmaceuticals." Although the disclosure statement at the end of the article is no more specific than that, I assume that the grants were given specifically to conduct this study.

What ePharma Pioneers Can Teach Today’s eMarketers

I'm leading a panel discussion at an upcoming conference that will soon be announced. The panel will feature several people who I met at the first and only FDA public hearing on the issue of how to regulate drug and device promotion via the Internet. It may also include a few newbies, who I invite to contact me if they are interested in being a panel member. You can contact me via email at johnmack@virsci.com

Here's my synopsis of the panel discussion:

Been There, Done That!
Two quotes come to mind when I think of the current brouhaha over recent FDA enforcement actions regarding search engine drug ads: “Those who are ignorant of history are doomed to repeat it” and “It’s déjà vu all over again.”

Most new media marketing proponents within drug companies and agencies employed by them were not on the scene in 1996 when the FDA convened a two-day public hearing where it heard testimony from dozens of experts organized into several panels. Panelists included representatives from organizations such as the following:

* Advertising Agencies
* Consumer Advocacy Groups (eg, AARP, Public Citizen, etc.)
* Health Web Sites
* Interactive Media Agencies
* Legal Firms
* Medical Communications Companies
* Medical Journal Publishers
* Medical Journalists
* Pharmaceutical Companies
* Physician Organizations (eg, American College of Cardiology)
* State Attorneys General
* Technology Companies

This session is designed to reproduce on a smaller scale that discussion, but updated to include health and medical bloggers and others engaged in social media.

The panel will include a mixture of “oldsters” who participated in the 1996 hearing plus “newbies” who are experts in today’s technology. Hopefully, the old dogs can teach the new dogs a thing or two and vice versa. Conference attendees will benefit from the dialogue no matter how old the dog!

Will Latisse Turn Brooke Shields' Blue Eyes Brown?

Long before there was a Hanna Montana there was a Wanda Nevada -- a 1979 movie starring Brooke Shields and Peter Fonda. I saw the movie yesterday.

I also saw the first TV ad for Latisse starring Brooke Shields last night during a re-run of "Desperate Housewives." Latisse is Allergan's "new" drug approved by the FDA for "hypotrichosis."

Hypotrichosis, according to a Wikipedia entry, "is the term dermatologists use to describe a condition of no hair growth. Unlike alopecia, which describes hair loss where formerly there was hair growth, hypotrichosis describes a situation where there wasn't any hair growth in the first place."

That, however, is NOT how Allergan describes the condition. According to the "Patient Information" sheet, "Hypotrichosis is another name for having inadequate or not enough eyelashes."

I imagine asking asking a woman if she has "adequate" or "enough" eyelashes is like asking a man if he has a "big" enough or "hard" enough penis. It is unlikely, therefore, that any woman wouldn't want, at least, to try this product once.

BTW, the "full prescribing information," which I am sure nary a single consumer will ever read, says "LATISSE™ (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness." Nothing about "inadequacy" or "not enough" here.

In the TV ad and Latisse Web site, Brooke explains why she was a good candidate for Latisse:

"I thought I'd be a good candidate for Latisse," says Brooke in her video diary on the Web site, "simply because over the years I've just been ripping off my false eyelashes while on Broadway and Allergan approached me and said 'this is a product, it works, it's FDA approved,' and my interest just piqued!"

I'm sure it "piqued" (or should I say "peaked") even more when Allergan told Brooke how much they were willing to pay her to shill their product! Watch her interest "peak" in the video here. You can also amuse yourself in "Brooke's Gallery," where you can see "before" and "after" photos -- over a 16-week period -- from every possible angle and zoom in and out! From the looks of it, Brooke earned every penny Allergan paid her! I wonder if the product manager got a personalized and autographed photo?

Brooke, like many users of Rx medications before her, is impressed that her medication is "FDA approved." As if that is equivalent to saying it is completely safe.

Recently, the FDA came out with some draft guidance (see "Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance") that indicates it may have a problem with patients underestimating the side effects of drugs just because FDA has approved them or approved the ads (or statements from drug companies) about them. "Consumers have preconceived ideas about the amount of scrutiny these ads undergo. Many believe FDA exercises tight regulatory control over the content of these ads and to some extent, believe that all ads have been pre-reviewed prior to airing. As a result, consumers are likely to expect that the most relevant risks have been included in the ad."

Perhaps Brooke is not aware of one the possible "relevant risk" that's mentioned in the "About Safety" page of the Latisse web site:

"Increased brown iris pigmentation has occurred when similar medications were instilled directly into the eye to treat elevated intraocular pressure/glaucoma. Although iris pigmentation was not reported in clinical studies with LATISSE™, patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent."

I have commented on this possible side effect back in October, 2008: "Allergan's Secret Plan to Thwart Homeland Security and the FDA Approval Process."

When Allergan says "similar medications," it really should have said "this medication" because Latisse is just another name for Lumigan, Allergan's anti-glacoma drug. Both are (bimatoprost ophthalmic solution) 0.03%.

Of course, application of Latisse is outside the eye, whereas Lumigan is applied to the eye. Yet, accidents happen and some Latisse can get into the eye if not carefully applied.

It would be a shame if Brooke's blue eyes turned brown.