Web 2.0: The New WILD, WILD WEST of the Internet!

I am sick and tired of excuses from pharmaceutical companies who, when caught anonymously altering Wikipedia entries about their products (see, for example, "Simply Irresistible: Abbott Tampering with Wikipedia Entries"), claim that "We’re looking into this but it’s not our policy and not what we do."

That's exactly what an Abbott spokeswoman said as reported here.

On another occasion, Wyeth defended itself for kicking plaintiffs lawyers out of a hotel by claiming:

"The hotel booking for these trials is done by a travel logistics firm. Without our knowledge, this firm took it upon themselves to ask the hotel to move the plaintiff’s team when they found out they were staying at the same hotel as our lawyers. Wyeth did NOT know they were doing this, nor did we authorize it. When our lawyers found out, they immediately put a stop to it and apologized to the plaintiff’s lawyers. This was a case of an overzealous vendor - nothing more." (Read the entire story here.)

That last bit is interesting...

Overzealous Vendors: Web 2.0 Banditos!
I have often seen it... vendors working for a pharmaceutical client and "pushing the envelope" with or without the client's knowledge. Sometimes, laws are broken as may have happened in Abbott's case when perhaps an overzealous vendor (or employee) edited out drug safety information in a Wikipedia entry. It may have also happened when my privacy rights were violated during a focus group interview (see "My Sojourn as Market Research Subject for Levitra").

Overzealous vendors are having a field day pushing the envelope on the Internet and especially in the social networking, Web 2.0 arena -- the new WILD, WILD WEST of the Internet.

Marketing Banditos are out there taking advantage of the system editing content, making comments to blogs disguised as common consumers, designing Google Adwords that flaunt FDA regulations (see Enbrel adwords shown below), etc. All done while employed by pharmaceutical companies.

These Adwords (click to enlarge) seem to violate FDA regulations that require presentation of major side effect information whenever a brand name and its approved indication are mentioned in the same ad. In addition, there are also requirements around the description of the indication. For example, "treatment for psoriasis" vs. "approved for the treatment of moderate-to-severe plaque psoriasis", the latter being the most severe type of psoriasis for which Enbrel is approved. MORE ON THIS LATER.

Self-regulation does not seem to be working. The FDA has its head buried in the digital sand (see "Where's DDMAC's Head At?"). PhRMA is quiet on guidelines for Internet marketing by drug companies (see "PhRMA Finalizes DTC Principles"). Etc., etc.

We need a new sheriff in Web 2.0 town!

Patients not Patents, Inc. founder and Executive Director, Jeffrey Light, may be just what honest folk are looking for (and maybe the last person the banditos want to see in town).

Listen to a LIVE podcast interview of Jeffrey Light next Thursday (September 6, 2007) at 2 PM Eastern. Click here for more information. After the show, you can listen to the audio archive on this Pharma Marketing Talk Channel page.

Cramer-Krasselt Sucks

Sucks up the Bissell Homecare account, that is. You know...Bissell the vacuum cleaner?

This account is worth $22 Million, according to AdAge (Cramer-Krasselt Picks Up Bissell's $22 Million Account).

You may know Cramer-Krasselt as the agency behind such campaigns as the notorious Rozerem Abe Lincoln/beaver duet (see "Takeda - Fire These Guys!").

That campaign is notorious because it has returned less money in sales than it cost Takeda to run! (See "Rozerem Ad Spending Exceeds Sales!") But -- and this is an important butt (as in butt of jokes inside the pharma industry) -- the ads have "cut through the clutter."

Guess what! Cutting through the clutter is very important for a vacuum cleaner company and that even extends to justification for hiring ad agencies:

"Cramer-Krasselt impressed us with bold ideas for our brand," said Ann Lamb, Bissell's director of communications. "They have a reputation for helping brands break through category clutter, so we're excited to explore new strategic marketing directions with them."

What a maroon!

Ann Lamb, meet Andy Hull, senior vice president of marketing at Takeda and a like-minded maroon!

P.S. Don't you think that for Bissell to survive the Swifter onslaught, that it needs to do a better job cutting through REAL clutter in homes rather than ad clutter in homeowners' minds?

My Upcoming Speaking Gigs

School's Open! Many colleges, at least!

My sons are back at Penn State and I imagine them in lecture halls looking as engaged as the students shown here. One can only hope!

Soon, pharmaceutical marketing executives also will be going back to "school," by which I mean attending the many industry conferences scheduled for this fall.

The Pharma Marketing Network Conference Calendar lists at least 10 live conferences and webinars in September. That list only includes conferences dedicated to pharmaceutical marketing and sales.

I have an interest in many of these conferences as a media sponsor, trade journalist, and/or speaker.

I will be speaking at a couple of these conferences in September and October and invite you all to attend. I don't get paid for doing this, but I do get some discounts off registration in case you are interested in attending.

If you are a good writer with some experience, I can get you a press pass in exchange for coverage of presentations for Pharma Marketing News (see "Free Passes Available to Conferences" and "We're Hiring!").

My speaking gigs in September and October include:

1. THE Pharmaceutical Marketing Event
On Wednesday, September 19, 2007, (11:30 AM) I will present my views on the trials and tribulations of pharmaceutical company use of Web 2.0 tools for marketing. The presentation is entitled "YouPharma: A Brave New World for Pharma Marketing." Here's the synopsis:

Guidelines for the Web 2.0 Era
YouPharma: A Brave New World for Pharma Marketing

It's not news to anyone that spending on DTC advertising and physician promotion is increasing, yet the return on these investments (ROI) is declining. A new approach to the way forward in pharma marketing is actively being pursued by pharmaceutical marketers and their ad agencies. This approach embraces “social networking” and other so-called “Web 2.0” technology, which is exemplified most notably in the non-pharma arena by YouTube and MySpace.

This trend could usher in a Brave New World of pharmaceutical marketing. Indeed, it will require a brave new pharmaceutical marketer to enter these uncharted waters teeming with public opinion mine fields and regulatory shoals.

Lack of regulatory guidance specific to online marketing should not hold the industry back from dipping its toes in the water. Just as PhRMA has developed guidelines for TV and print DTC, the industry should develop a coherent road map to guide its way through the brave new “YouPharma” world. This presentation will offer some starting points towards that goal.

• Where are the Web 2.0 mine fields?
• Evaluating Risk vs. Impact of various tactics
• Rules of Engagement (e.g., "Open Healthcare Manifesto")

I've written about this topic here and in Pharma Marketing News (see "YouPharma: New Rules for Pharma Marketing and Social Media"). Since then, the industry has moved forward and there are several case studies I can talk about.

I invite you to provide input on this topic and engage in the discussion thread (click here) I have set up at the Pharma Marketing Network Forums site.

2. Digital Pharma
Web 2.0 will also be the topic of a Point/Counter Point Interactive Debate I will be having with Marc Monseau, Director of Media Relations and J&J and the brains -- as well as main blogger -- behind J&J's corporate blog, JNJ BTW.

This "debate" will take place at 2:15 PM on Wednesday, October 24, 2007. Here's a synopsis:

A Point/Counter Point Interactive Debate:
Why Pharma Should Embrace Web 2.0 vs. Why The Industry Should Play it Safe and Hold Off for Now

Join a pharmaceutical industry corporate communications manager and an industry blogger in a debate of the issues surrounding the use of Web 2.0 technology – blogs, social networks, other user-generated content sites – by the pharmaceutical industry for marketing, corporate communications, and public relations purposes.

• Taking the Point is John Mack, a well-known publisher and blogger in the Pharma Blogo sphere™, who argues that it is time for pharmaceutical companies to use the new Web 2.0 tools available to improve its marketing and public image.
• The Counter Point position is taken by Marc Monseau, Director of Media Relations at Johnson & Johnson, who will discuss the regulatory, legal and other concerns that require a cautious approach to use of Web 2.0 by Pharma.

I usually do not handle the point side of this debate because I am more comfortable talking about best practices, compliance, and privacy issues related to using technology. Marc obviously has learned to deal with the legal and regulatory issues and has, by now, a lot of real world experience running the JNJ BTW blog.

All in all, I think this will be an interesting session in which we hope to engage the audience.

I also invite you to provide input on this topic and engage in the discussion thread (click here) I have set up at the Pharma Marketing Network Forums site.

Wikis and Social Networks for Marketing & Sales Collaboration: Will It Work?

What do you think of the idea of a secure, internal CafePharma-type Web site where sales reps can share their triumphs and failures, vote on who has the best ideas, discuss issues, and get feedback from their managers that everyone can see and learn from?

What about sales reps collaborating with marketers via a wiki tool that allows the reps to edit and comment upon detail aids, talking points, and other materials that sales reps use when selling to physicians?

These ideas and more were discussed in today's Pharma Marketing Talk podcast entitled "Web 2.0 Tools for Sales Force Effectiveness" (listen to the audio archive here). In that podcast, I interview Joe Miles, Project Director, EyeforPharma Conferences. Joe is organizing a Webinar on this topic for September 19, 2007 (see "SFE: Collective Intelligence Webinar").

Let me just share some thoughts about collaboration between marketing and sales and how Web 2.0 tools may be used enhance that collaboration.

More often than not, there's no love lost between the sales and marketing departments of pharmaceutical -- and other -- companies. Marketing produces the detail aids and other materials and sales dutifully use them -- at least they say they use them. More often than not the reps toss 'em or let them rot in their garages! In many cases, the suggested sales verbiage offered by marketers does not resonate with the customer.

I wrote about this problem some time ago in Pharma Marketing News (see "Marketing’s Role in Limiting Physician Access and What to Do About It"). I that article, Gerald J. Acuff Jr., Chief Executive Officer, Delta Point, a sales agency that enhances the effectiveness of sales representatives, pointed out a couple of problems that prevent marketing from preparing the best sales aids:

1. Not truly understanding the difference between a marketing message and a sales message. The copy that accompanies sales aids, for example, is not written with an understanding of how sales are made; and
2. Providing to the field suggested sales language that “closes down” customers. Examples of verbiage that signals the wrong thing.

I won't get into the details here. You can read the article to learn more.

Another common problem caused by the siloed boundary between the field force and marketing is that sales reps deliver the same highly-scripted blanket messages to all of their physician clients. How can a siloed pharmaceutical company create an organizational structure and process where marketing and sales managers work more closely together?

You can hire experts like Mr. Acuff to correct these problems, but some pharmaceutical companies are turning to Web 2.0 tools to leverage the "wisdom of crowds," which in this case are the thousands of sales reps within the organization.

At least that is what Joe Miles and some of the experts that will speak at the eyeforpharma webinar think.

To illustrate the wisdom of crowds, Joe asked a recent conference audience to guess the number of jelly beans in a jar. I forget the exact range of the guesses -- listen to the podcast to find out -- but the average was extremely close to the actual number.

Can that type of crowd "wisdom" be applied to real world problems and specifically to the problems mentioned above?

I can imagine hundreds of reps tweaking and editing sales aid copy and voting on which version is the best, but I have a problem imagining marketing pros taking them seriously. All the social networking tools in the world cannot make up for a dysfunctional organization or overcome tradition, which says that marketing is responsible for the words, reps are responsible for sticking to the script.

But, hey! I could be wrong -- it wouldn't be the first time. I look forward, therefore, to eyeforpharma's webinar, which is supposed to feature case studies from the real world! Hope to see you there!

FDA at a Mall Near You: The Manchurian Connection

The FDA will be coming to a mall near you...again!

You previously may have seen FDA interviewers following a "mall-intercept" protocol, interrupting the shopping of about 1,800 "self-identified, moderately overweight" shoppers at malls to survey them on the content and format of the brief summary in direct-to-consumer (DTC) print ads (see "FDA Coming to a Mall Near You?").

Now, the FDA plans to do a new study: "consumer evaluations of variations in in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements." (See notice here.)

The FDA is trying to determine whether the use of competing, "compelling" visual information about potential drug benefits interferes with the viewers' processing and comprehension of risk information about drugs in DTC advertising or with their cognitive representations of the drugs.

Take the Nasonex, anti-allergy TV ads, for example. You know, the one with the talking, French bee.

A study reported by Ruth Daly of Duke University, and summarized at an FDA hearing in November, 2005 (see "FDA DTC Hearings: Snippets from Day 1"), discovered that the bee beat its wings furiously when risk information was being presented but was still when benefit information was presented. Day claimed that the beating wings divert viewers’ attention from the risk information.

How devious DTC advertisers are! I never thought they were clever enough to employ such nefarious devices to subvert the fair balance guidelines of the FDA, which never dreamt of looking at such visual devices! Until now, that is.

Notwithstanding the credibility of her studies, Day’s main point was this: In TV and print DTC ads "risk information is physically present but functionally absent."

The proposed FDA study seems designed to determine if there is any merit to Day's accusation.

Since the FDA is seeking comments on the methodology of the proposed study, I will offer my comments.

The protocol calls for FDA screeners to look for consumers over the age of 40 -- which shouldn't be too hard to find in malls -- as long as they speak English, but don't read Chinese.

Whaa?!

What's reading Chinese have to do with DTC TV ads? Do these ads include subliminal Chinese characters with coded messaging for the Chinese-reading citizens of this country?

Turns out that the protocol will use the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads' imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. (See "A Misattribution Approach to Implicit Attitudes").

Attention K-Mart Shoppers (aka, FDA mall-intercept study participants):

"We will be showing you pairs of pictures flashed one after the other. The first picture is a photograph. You should do nothing with the photograph; it is simply a warning signal that the second image is about to appear. The second image is a Chinese character. Your job is to judge the pleasantness of each Chinese character."

Here's an example of how this might work:


Now I understand why the FDA does not want Chinese people as participants in this study.

They might read the character following Bush's image and understand that it says "One who tries to deny health insurance for children" whereas the character following the Nasonex bee might translate as "Nice pet to have around the house while you do household chores." [I understand that Chinese characters pack a lot of meaning!]

Are Chinese Characters Neutral These Days?
But these days -- what with lead paint in toys imported from China, tainted toothpaste made in China, and counterfeit drugs manufactured in China -- ALL Chinese characters might elicit "unpleasant" feelings in most English-speaking Americans over 40!

I suggest, therefore, that the Chinese characters be replaced with Mayan hieroglyphics! Here's some the FDA can use:
After all, how many Mayans are likely to be found in malls? Like, zero! Of course, you'll have to eliminate the glyphs that show penises or hearts been ripped out of teenage girls!

How About Measuring Saccadic Eye Motion?
I can't help wonder what Lee Weinblatt, Founder and Chief Executive Officer of the PreTesting Company, thinks of AMP.

What PreTesting measures is Saccadic Eye Motion. You cannot see without this motion. Humans and other animals do not look at a scene in a steady way. Instead, the eyes move around, locating interesting parts of the scene and building up a mental 'map' corresponding to the scene.

"After years of debate," reports the Newark Star Ledger (see "Measuring Drug-ad Interest: The Eyes have It!"), "some researchers now think saccadic eye motion provides a kind of window into subliminal thoughts. Passive eye monitoring, Weinblatt said, is a more accurate way of gauging a subject's response than diaries or focus groups, which depend on the honesty of participants or their willingness to push buttons."

I interviewed Weinblatt in a Pharma Marketing Talk podcast back in July (see details here; listen to an audio archive here; read the article here). He's a very interesting and lively person. You'll be entertained and more knowledgeable about measuring DTC ad effectiveness after hearing what Lee has to say!

August Issue of Pharma Marketing News: Wasting Money on DTC, Time to Rethink How to Engage Physicians, Whistleblower Novels

The summer (August 2007) issue of Pharma Marketing News -- an independent and provocative monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives -- is coming Tuesday, August 21!

Don't miss it! Subscribe here. It's free!

Here's the preview:

• Merck Rejiggers Its Marketing Mix: Will Other Pharma Companies Follow?
  Adam Schechter, President of Merck US Human Health, made this statement not long ago at a Goldman Sachs healthcare conference: "Industry must embrace new ways of engaging physicians on their terms." Clearly, physicians are not embracing pharma on THEIR terms. Schechter laid out some details of Merck's 2007-2010 goals.
  

• Stop Wasting $Millions on Ineffective DTC Ads! Testing Technology Can Help Improve Ads and Engage Viewers
  You're wasting hundreds of millions of dollars on ads that aren't delivering your key messages! And it has nothing to do with FDA rules. That’s the opinion of Lee Weinblatt, Founder and Chief Executive Officer of the PreTesting Company. Weinblatt’s company has been measuring the effectiveness of drug ads since 1974. Of course, at that time there were only print ads aimed at physicians in medical journals. Today, the pharmaceutical industry spends in excess of $5 billion per year on direct to consumer (DTC) advertising and billions more on physician ads. This article highlights PreTesting's ad measurement technology and Mr. Weinblatt reveals interesting insights about the major mistakes that pharmaceutical advertisers make with regard to measuring the effectiveness of their ads. The article also presents 17 key findings on How to Create an Effective Drug Ad.
  

• The Changing Landscape of Physician Interactions: Strategies to Improve Interactions with Key Physicians
  Pharmaceutical companies are under increasing pressure to reduce costs, speed the time-to-market for new products and ensure that physicians are informed and educated about their products. Traditional interaction methods, however, are becoming less effective as the quality of interactions between physicians and pharmaceutical representatives have decreased. Brand marketing managers are looking to augment traditional offerings with non-personal selling technologies to reach new segments or healthcare professionals. MERGE Rx recognizes these changes and offers a new generation of Web-enabled software that helps pharmaceutical companies manage physician interactions—including key opinion leader (KOL) management, phaseIV trials, and eDetailing—from a single, secure and scalable access point.
  
  
• A Tale of Two Pharma Whistleblower Novels: Big Pharma and Killer Drug
  My summer reading included two novels about the pharmaceutical industry that featured industry whistleblowers and/or were written by whistleblowers. The first novel I read was Big Pharma, The Novel, written by John Prieve, a former pharmaceutical executive. The second novel, Killer Drug, is the second by Peter Rost, a well-known whistleblower and former Pfizer executive. Although whistleblowing figures prominently in both novels, the two are as different as night and day. Killer Drug is the night – very dark and lacking depth – whereas Big Pharma is the day – shedding light on real-world pharmaceutical marketing and sales practices. This article is a review of both novels and includes insights from several bloggers and other experts, including Jane Chin.

Don't miss it! Subscribe here. It's free!

DTC Tsunami: Duh!

A "new" study published in the NEJM concluded that "spending on direct-to-consumer [DTC] advertising has continued to increase recently in absolute terms and as a percentage of pharmaceutical sales in spite of pressure on manufacturers to curtail such advertising" (See "A Decade of Direct-to-Consumer Advertising of Prescription Drugs").

[In the interest of furthering "medical science," no subscription is required to access the full text of this article. However, if you want to read up on "A Genetic Risk Factor for Periodic Limb Movements in Sleep," you'll have to pay a fee. Sorry, GSK!]

This study has already been covered by several bloggers. So, instead of rehashing everything someone else thought important, I'll merely quote a couple of pundits and then add something new (ie, more data and a prediction):

Ed Silverman over at Pharmalot pointed out that "Ultimately, the study authors offered a tepid and rather obvious conclusion: 'Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it. Our findings suggest that calls for a moratorium on such advertising for new drugs would represent a dramatic departure from current practices.'"

That's one reason for the "Duh!" in the title of this post. Another is a reaction to a post made by "Insider" at PharmaGossip entitled "DTC - an advertising tsunami":

"An eyebrow-raising report from the NEJM reveals that spending growth in direct-to-consumer advertising by US drug companies has entered exponential mode...Growth in DTC activity over the ten year period has averaged 14% per year and will this year hit $4.2 billion (€3.12bn; £2.11bn)."

Actually, the growth in DTC ad spending averaged 14.2% from years 2002 to 2005, not over the entire 10-year period. [Check the facts as presented in the NEJM article.] NOTE: The rate of "increase" in DTC spending between 1997 and 2005 ranges from -3.7% (a decrease!) to 38.9%. It is quite easy, therefore, to cherry pick whatever % increase between those extremes that fits the purpose.

The NEJM authors seem surprised that DTC ad spending would rise at such a rate DESPITE criticisms and pressure on pharma to reduce spending. I say the spending increased precisely BECAUSE of this pressure, especially from Congress.

Pharma marketers have always lived by the rule "spend it or lose it." In the current political climate, the rule is "spend it while you can."

In fact, back in March, 2007, I suggested that "the drug industry is on a spending spree in anticipation of the spending drought to come," by which I meant a moratorium on DTC imposed by Congress (see "Spend, Spend, Spend Before the End, End, End").

Now that the threat of a DTC moratorium has faded and drug companies are laying people off and cutting back on their budgets, the rate of increase in DTC ad spending is likely to decrease. That is, I predict that you won't see a 14.2% in DTC spending this year vs. last year.

What's interesting, however, is DTC spending may soon surpass DTPhysician promo spending (detailing + journal advertising), perhaps as soon as 2011 or 2012 (see chart below).
To create this chart, I used the same numbers that the NEJM authors used (which come from a GAO report, which picked up the numbers from IMS et al).

I use 11.5% as the average rate of increase in DTC spending -- this is the average rate from 2000 through 2005; the NEJM authors obviously wanted a higher number and that's why they threw out the "lean" years of 2001 and 2002; the near future also promises to be lean and, therefore, I believe 14.2% is too high a number to use for predictive purposes; it's fine, however, for the political purposes of the NEJM!.

I also have adjusted the GAO numbers and used different figures for DTC spending in 2005 and 2006. Whereas the GAO uses $4.2 billion for 2005, I use $4.89 billion. This is based on numbers reported in Med Ad News Advance (May 2007), which states "Direct-to-consumer expenditure for pharmaceutical advertising totaled $5.61 billion during 2006, a 15.4% increase compared to 2005." Then, I plugged in the $5.61 billion number for 2006 and projected out from there based on an 11.5% increase per year. For the increase in DTPhysician spending, I used 5.42% as the average annual increase between 2000 and 2005 (based on the GAO report).

Rozerem's Cheapskate Sweepstakes Violates Children's Online Privacy Protection Act

Desperate times call for desperate measures.

No, I'm not talking about the "War on Terror." I am talking about about Takeda's war to win market share for its beleaguered sleep aid, Rozerem.

Regular readers of this blog know that I have criticized the Rozerem DTC campaign as ineffective and operating in negative ROI (return on investment) mode (see "Rozerem Ad Spending Exceeds Sales!").

But I am not the only one to see problems with the current Rozerem ad campaign. Recently, I spoke with Lee Weinblatt, Founder and Chief Executive Officer of the PreTesting Company, which tests the effectiveness of DTC and other ads (listen to this Pharma Marketing Talk podcast interview with Lee).

"Talking about dreams means nothing to older people who cannot sleep through the night," says Weinblatt. "They may keep looking at the beaver, but wondering what Rozerem has to do with dreams."

Weinblatt concedes that the Rozerem ads enjoy high recall, but he questions if that is enough to sell product.

"Recall by itself means very little to consumers," says Weinblatt. "They can recall many products, but if you do not make it emotionally important to them—especially when you asking them to call up a doctor, make an appointment, pay a co-pay, and admit to having a problem—you are really going down the wrong path."

What Rozerem needs is a better DTC campaign that emphasizes the benefits of Rozerem. One such benefit, according to details you can only get by digging deeper on the rozerem.com web site, is that it is non-habit forming.

Only in one Rozerem commercial – "Catch the Bus" – is this advantage espoused by the beaver! But that line goes so fast that if you had taken another bite of snack food you would have missed it!

Cheapskate Sweepstakes!
Maybe that advantage, however, is not enough to emotionally bond with consumers. Takeda needs to find another selling point that it can promote and now has turned to some old-fashioned market research to find the answers.

Hence, the Rozerem Sweepstakes, where you can win "cool prizes" -- NO PURCHASE NECESSARY!

But there's a catch:

"Just tell us a little about yourself and you'll be entered for a chance to win a Grand Prize or one of 5 second prizes in the Rozerem Sweepstakes!"

The prizes are: Mattress and luxury bedding ensemble -- you pick the size -- either queen, king, or California king and a 4GB MP3 Player.

An astounding 6 people will win one of these prizes! Total value $4,000 - $5,000, TOPS! This is so cheesy! A company that shamelessly spends about $100 million a year on beaver commercials can only shell out $5,000 in prizes in order to collect vital marketing research data?

The Violation
Well, I couldn't resist entering the sweepstakes. But, first, I decided to do a little test. The form asked for my date of birth. I entered 02/06/1997, which would make me 10 years old.

As expected, the form picked up that I was too young to enter and told me exactly how old I needed to be to enter (see figure below; click to enlarge and read).

As any red-blooded American ten-year old boy who yearned for an iPod would do, I re-entered my date of birth so that the form would accept my data. No problem. It was accepted immediately without question.

This way of handling age entry violates FTC guidelines on collecting personal information from children on the Internet and may be against the law -- specifically, the Children's Online Privacy Protection Act or COPPA. Whoops!

According to the FTC, "For sites that choose to age-screen, age information should be asked in a way that does not invite falsification" and "In addition, we recommend using a temporary or a permanent cookie to prevent children from back-buttoning to enter a different age." (See COPPA FAQ's.)

Takeda might face a stiff fine from the FTC if that agency ever caught wind of this. Hmmm... maybe there's an intern working at the FTC to whom I could complain.

The sweepstakes form goes on to ask the typical kinds of questions:

1. When you are having difficulty sleeping (falling asleep), which of the following do you usually do? [FUN ANSWER NOT INCLUDED: Count beavers; wink, wink, nod, nod.]
2. How often do you have trouble sleeping?
3. What do you think is the cause of your sleep problems? [FUN ANSWER NOT INCLUDED: laying awake wondering what's with the guy in the space and/or deep-sea diving suit.]
4. What interests you about Rozerem? [FUN ANSWER NOT INCLUDED: How it can continue to do so poorly after so much money has been spent promoting it!]

The last question is the money question. Here's what Takeda wants to know:

• It has shown no potential for abuse or dependence in clinical studies
• It works with my body's normal sleep-wake cycle
• It won't make me groggy the next day
• Its side-effects profile
• I can take it when I need it and stop when I don't

Now how would consumers know these things? Certainly, they are not highlighted in the ads. I guess this is less about actual research and more about planting benefit statements in the minds of respondents.

P.S. Good luck with that!

State Sponsored Pharma Ads: It Could Happen!

The more magazine ads smokers see for the nicotine patch and other quit-smoking aids, the more likely they are to try to quit smoking and be successful -- even without buying the products, finds a new Cornell study.

"We think that the reason may be that important 'spillover effects' from advertising may be occurring, which has important implications for advertising for a wide range of health products," said Alan Mathios, professor of policy analysis and management at Cornell and a co-author of the study

Mathios also thinks this applies to pharmaceutical ads for other products like statins, maybe even dopamine agonists (eg, Requip) that prevent twitchy legs. OK, he didn't include the latter, but he did say some pretty outlandish things.

Take this, for example: "Ironically," says Mathios, "ads for prescription smoking-cessation products are more heavily regulated than cigarette ads because of mandatory risk disclosures."

Whoa! I've never heard of the FDA requiring, for example, that DEATH be mentioned as a side effect of smoking-cessation products. Death, however, IS prominently mentioned in Surgeon General warnings appended to cigarette ads.

Note: the one time that a pharmaceutical DTC ad mentioned death as a side effect -- the 150-second Celebrex TV ad -- all the pundits laughed and wondered what the hell Pfizer was thinking (see, for example, "Celebrex Ad: Let's Dive Deeper").

Not only that, in a radio interview ("On the Media," a NPR show aired on New York Public Radio), Mathios stated that "if the pharmaceutical industry spent an extra 10% per year in anti-smoking product advertising in magazines, that would cause an additional 80,000 people to quit smoking."

Of course, that additional spending may not help sales of the products and that is why Mathios seriously suggested that the government give pharmaceutical companies money to do more DTC advertising!

"Given the public service these advertisements are providing," suggested Brooke Gladstone, the radio hostess, "maybe the government should be subsidizing the ads, especially if they work against, in some cases, the actual profitability of the company." Nice setup, Ms. Gladstone!

"That's actually a reasonable conclusion to make," said Mathios [BROOKE LAUGHS]. "If many people are actually quitting without the use of these products, the ads are generating benefits to society that's not being incorporated into [the advertiser's] profit. And so in some sense, these ads are doing exactly what the public health authorities try to do in their advertising, in their big campaigns to get people to quit."

[You can read the transcript here.]

This kind of thinking takes my breath away!

Here we have a study surely to be embraced by the pharma industry in support of its long-standing argument that DTC performs a public service. They will definitely cite the study to make the case that DTC advertising should not be hobbled in any way by the government -- not even by imposing a temporary, product-selective moratorium.

In fact, I imagine pharma ad execs testifying before Congress in much the same vein as Nick Naylor did in the movie "Thank You for Smoking." I don't have the exact quote, but you know what I mean -- something about how smoking actually has a beneficial effect on some people and how Vermont cheese can cause high cholesterol and kill people. "That's ludicrous," said Senator Ortolan Finistirre, "The great state of Vermont will not apologize for its cheese!"



P.S. Despite repeated email requests to Dr. Mathios, he was not able to get me a review copy of the published study. Perhaps someone out there who has access to the Journal of Political Economy, which published the study, can send me a copy. I'm not holding my breath for that to happen!

J&J Lawyers Go Wild; PR on Vacation!

J&J's recent announcement that it is filing a civil suit against the American Red Cross (ARC) has been likened by some in the blogger world to "kicking babies" (see "Trademark Law Gone Mad"). At issue is J&J's claim of "unauthorized" licensing of the famous symbol by ARC to third-party, for-profit organizations selling products like baby mitts, nail clippers, combs, toothbrushes and humidifiers

Criticism of J&J's action is also rampant in the Pharma Blogosphere (see "Blogger Brouhaha Over the Cross"):

"About the most foolish PR move by any drug company this year..Or is it the worst move in a decade???," said Peter Rost (NRx Blog).

"This can't be a good public relations move," said Ed Silverman at Pharmalot.

"There are times when even the most fertile imagination would have trouble concocting fiction stranger than business reality," according to Scott Hensley at WSJ Health Blog.

"...will bring plenty of short-term odium," said Steve Woodruff over at Impactiviti blog.

The sad fact is, no matter what the legal basis for this action is, J&J has allowed its legal department to outweigh its good public relations by acting independently and seemingly catching the J&J corporate communications department off-guard and on vacation.

"Our small media relations group was reduced even further by summer vacations," claimed Ray Jordan, pinch-hit blogger over at J&J's JNJ BTW blog. He is filling in for Marc Monseau, Director of Media Relations, who is on vacation.

"Lawyers gone wild" is the only way to explain why this suit would be announced when key PR people are out of the loop!

We may see more lawyers going wild in pharmaceutical companies in the future. Lawyers are ascending the corporate ladders of many big pharma companies: This July, Merck announced the promotion of corporate counsel Kenneth Frazier to succeed Peter Loescher as president, global human health, "effectively making him the company's chief operating officer," according the "Industry Veteran" over at The Health Care Blog (see "Time to get Shakespearean at big Pharma?")

"Given Pfizer's earlier decision to make their corporate counsel, Jeffrey Kindler, the CEO there, Frazier's promotion means two Big Pharma companies within the past year have elevated lawyers to key, strategic positions. The moves in both cases indicate the unwillingness of the respective companies to cleanly break from the unsavory and dysfunctional practices of their recent past."

Lawyers have long been involved in writing those "brief summaries" that befuddle consumers trying to read up about the drugs they are taking (see "Future of Drug Print Ads").

Can J&J Regain Lost Goodwill?
Pharmaceutical companies need to protect its assets like patents and trademarks. But these tangible assets need to be balanced against intangible assets like goodwill and its employees.

I can only imagine how much goodwill J&J has lost over this issue.

Johnson & Johnson has had a lock on first place for corporate reputation in the Wall Street Journal/Harris Interactive corporate reputation study since the survey began in 1999. Every year, J&J successfully "dodged the bullets fired at other pharmaceutical companies. It scored well for the quality of its products and for emotional appeal because of people's warm feelings about its baby-products business. It also received the highest scores for being ethical and trustworthy. J&J 'is as American as Mom and apple pie,' one respondent commented," according to the WSJ.

My mom, rest her soul, would NEVER have sued the American Red Cross!

I am sure many employees at J&J are also thinking the same thing. J&J's action has minimized their employees generous donations to this charity. So, not only do the J&J PR people have to deal with us bloggers and journalists, they also need to work with their employees. My advice, as always, is to give your employees a voice in your blog. Let us hear their honest comments about this issue.

Disclaimer: I have had a number of unofficial conversations with Marc Monseau about his blog and the company's social media communications strategy, but none on this subject.

Point-Counter Point: Monseau vs. Mack!
Marc Monseau and I will be debating the use of Web 2.0 technology (eg, blogging) by pharmaceutical companies at the Digital Pharma Conference on October 24, 2007 in Princeton, NJ.

Here are the particulars:

Why Pharma Should Embrace Web 2.0 vs. Why The Industry Should Play it Safe and Hold Off for Now

Join a pharmaceutical industry corporate communications manager and an industry blogger in a debate of the issues surrounding the use of Web 2.0 technology -- blogs, social networks, other user-generated content sites -- by the pharmaceutical industry for marketing, corporate communications, and public relations purposes.

• Taking the Point is John Mack, a well-known publisher and blogger in the Pharma Blogosphere™, who argues that it is time for pharmaceutical companies to use the new Web 2.0 tools available to improve its marketing and public image.
• The Counter Point position is taken by Marc Monseau, Director of Media Relations at Johnson & Johnson, who will discuss the regulatory, legal and other concerns that require a cautious approach to use of Web 2.0 by Pharma.

Takeda Plots New Rozerem Campaign?

MM&M reports that "The whimsical consumer campaign for Takeda's insomnia drug Rozerem has generated lots of buzz, just not the kind of recognition that leads to new patient starts."

That the Rozerem "whimsical" DTC emperor has no clothes has been apparent to many observers for a long time (see, for example, "Rozerem Ad Spending Exceeds Sales!").

New Rozerem ads -- "Catch the Bus" and "Off to Work" -— are said to feature stronger brand mentions. "Brand linkage metrics, consumer awareness numbers have all steadily progressed over the life of the product," says Chris Benecchi, director of Rozerem marketing for Takeda Pharmaceuticals North America. "In the very beginning, you find yourself as being, in the mind of the consumer, 'You're the product...with Abe Lincoln and the beaver.' Now 'Rozerem' is coming through much more strongly," says Benecchi.

I am having a problem parsing all this marketing-speak. But it seems that Benecchi is relying on the wrong measure of DTC success according to Lee Weinblatt, Founder and Chief Executive Officer of the PreTesting Company. I interviewed Lee in a recent Pharma Marketing Talk podcast.

"Recall by itself means very little to consumers," says Weinblatt. "They can recall many products, but if you do not make it emotionally important to them -- especially when you asking them to call up a doctor, make an appointment, pay a co-pay, and admit to having a problem -- you are really going down the wrong path."

The two new Rozerem ads do not seem to build any more of an emotional bond with consumers than the previous ads, unless you really like blue unicorns.

Ad spending for insomnia drugs lead the DTC ad spend pack: In 2006, Sepracor spent $316 million for Lunesta DTC advertising, Sanofi-Aventis spent about $180 million on Ambien and Ambien CR DTC, and Takeda spent about $110 million on Rozerem ads.

"We are promoting at a level that we feel is really the right spending point for us to go and have an effect," said Benecchi.

"One has to wonder whether the firm is growing impatient with the promotional effort, whose ROI in terms of revenue has been lackluster," reports MM&M. "Through June of this year, market share hovered at 3%, according to Verispan, compared to Lunesta's 18%, and the 66% share owned by Ambien CR and Ambien. Datamonitor predicts Lunesta, Rozerem's closest competitor, will cross the $1-billion sales threshold next year and increase its market share to 22%"

No matter what Takeda spends on Rozerem DTC advertising, it won't increase Rozerem's market share without making major changes to its DTC campaign. Ads featuring beavers on bus stops and blue unicorns in the office are merely "tweaks," not real changes. The buzz is wearing thin. It's time to do something entirely different.

As I said many times before, Takeda should "Fire These Guys" and disengage itself from agencies and marketing directors that measure DTC ROI in terms of "buzz" rather than new scrips written, IMHO.

Brandweek Hires Peter Rost, Moves to the Dark Side!

The pharmaceutical industry often complains that the "media" are unfriendly and biased against the industry. And at least one blog that shills for the industry -- DrugWonks run by PR agency Manning, Selvage and Lee's Peter Pitts -- is devoted to counteracting negative industry stories in the press.

Until recently, I didn't buy their arguments. I've seen as many stories in the press touting pharmaceutical products and practices as I have seen criticizing them (see, for example, "Am I Dreaming, or Is This [News Story] a Rozerem Ad?"). But the recent hiring by Brandweek of Peter Rost -- unabashedly a drug industry foe (he is, after all, a whistleblower and built a business on whistleblowing) -- to take over for Jim Edwards at BrandweekNRX blog has jaded my opinion of the media.

As I pointed out over at Pharma Blogosphere^TM, "Rost as BrandweekNRX blogger makes perfect sense... if you intend to flush your blog down the drain as far as pharmaceutical industry readers are concerned -- except for their lawyers, that is." (See "It's Official. Rost Takes Over BrandweekNRX!")

I say this based upon two bits of research I have done:

1. Pharma Blogosphere Survey: The First Ever Survey of Readers About Pharma Blog Credibility, Readability, Usefulness, and Bias (see Summary here).
2. Pharma Marketing Blog Reader Survey (see a interactive Summary here)

Looking at the results from readers of this blog -- 41% of whom are employed in the pharmaceutical industry -- I find that whereas 24% of survey respondents read BrandweekNRX on a regular basis, only 17% read Peter Rost's Question Authority blog on a regular basis. This suggests, as far as my survey is representative of pharma blog readers on the whole, that BrandweekNRX's readership will drop (perhaps after an initial transient uptick attributable to curiosity).

The Pharma Blogosphere reader survey is more revealing as the following charts show.

Rost is considered MUCH more biased against the industry than is BrandweekNRX:

The bars show the % of respondents selecting the bottom 2 boxes ("very/somewhat" critical of the industry) vs. top 2 boxes ("very/somewhat" supportive of industry). Red arrow points to Rost's data, blue arrow to BrandweekNRX's. Please click on image to enlarge and read.

BrandweekNRX ranks very high in Overall Honors, whereas Rost is just average:

Only blogs are included for which data from 14 or more readers were available. That is, if less than 14 people answered this question, their responses were not included in the analysis. Red arrow points to Rost's data, blue arrow to BrandweekNRX's. Please click on image to enlarge and read.

Among pharma industry readers, BrandweekNRX won top honors in usefulness and credibility, whereas Rost didn't make top honors in any category:

This analysis excludes responses from respondents that rarely or never read the blog; plus more than 5 responses were necessary for a blog to be included in the analysis. BrandweekNRX highlighted in blue. Please click on image to enlarge and read.

There's a saying us Brooklynites have to live with all our lives, no matter where we end up calling home:

"You can take the girl [boy] out of Brooklyn, but you can't take Brooklyn out of the girl [boy]."

Which means, you can always recognize someone from Brooklyn by their accent and bias for their place of birth.

Applying this to Rost at BrandweekNRX, you could say that "You can take Rost out of Question Authority [where he is anti-industry], but you can't all of a sudden expect him to be an unbiased journalist."

IMHO, Brandweek should seriously consider the data I have presented above, because it signals that BrandweekNRX may lose some of its credibility and usefulness, especially among its most important audience: pharmaceutical executives.

Of course, you have to balance that against all the great publicity and perhaps greater readability that Rost will bring to BrandweekNRX.

The notoriety, however, will not last long. Perhaps that's why Rost hints his stint at BrandweekNRX may only be a temporary assignment (ie, "for a while"). Maybe it's destined to last only until Brandweek sees the numbers from its own reader research!

The Drug Advertising Blame Game

In case you are wondering who and what to blame for everything evil about the pharmaceutical industry, consider the list of "10 reforms that drug advertising needs right now."

This list was compiled by Jim Edwards in his last post to BrandweekNRX, the blog associated with the venerable Brandweek print publication. Edwards is leaving to take up studying journalism at Columbia University. Surprisingly, Brandweek has hired Peter Rost -- pharma's most vehement critic -- to replace Jim (see this post to Pharma Blogosphere, which broke the story yesterday).

[Peter Rost as Journalist. I am withholding my questioning of Brandweek's wisdom to hire such an outspoken critic of the pharmaceutical industry. Although Jim Edwards wrote for both the blog and the print publication, it is not certain that Rost will do the same. Perhaps he will stick only to blogging, which I have no qualms about. It is problematic, however, for a blogger to also be a journalist (see "Journalistic Suicide or Blog Assimilation?"). Bloggers are expected to be opinionated and proud of it (see "I'm Non-Objective and Proud of It!"), whereas journalists are expected to suppress their opinion when writing articles. O well! I suppose I am being an old fuddy-duddy. When Rupert Murdock buys the Wall Street Journal, we know the writing is on the wall for unbiased journalism everywhere!]

Back to Edward's "10 reforms," which are:

1. In TV ads for drugs, the FDA should ban disjointed imagery during side-effect warnings
2. Reminder ads should be illegal
3. Product placement should be illegal, paid or unpaid
4. Drug company PR people should be properly trained to answer straight questions with straight answers
5. Pharma companies should be required by the SEC to break out their promotional costs
6. FDA should require relevant head-to-head studies for second-to-market drugs
7. FDA-mandated transparency in Continuing Medical Education
8. FDA-mandated transparency in grants and donations for non-profit groups
9. FDA mandated transparency for payments and gifts to doctors
10. FDA mandated transparency in prescription-writing habits

Whoa! FDA should do this, FDA should do that! Jim, read the law that governs the power of the FDA. It doesn't give the FDA authority to do half the things you want it to.

Not only that, only reforms #1 and #2 (and maybe #3) on your list really are about advertising. I think you should have entitled your post "10 reforms that the drug industry needs right now." Let's not blame everything wrong with the industry on advertising, which is a typical ploy of those whose agenda is anti-industry and who want to misled the public on the issues.

Don't get me wrong. I agree with a lot of what Edwards says needs to be done. I just don't think it's all about advertising and marketing. Therefore, it's a mistake to put all this in FDA's court.

Let's look at a few of the reforms that are of interest to me.

#1: Side effect warnings in DTC ads
Edwards cites a study by Ruth Day of Duke University "showing that when drug ads listed benefits, the images on the screen matched the voiceover and moved slowly. But when side effects were listed, the images often became mis-matched to the voiceover and moved much faster or were more distracting."

I remember that study very well, Jim. I was in the audience at the FDA hearing when she presented it. Where were you?

Day's methodology was, to say the least, laughable, especially when she recounted an analysis of how fast the bee's wings fluttered in the Nasonex TV ads. I have already "bitch slapped" that analysis elsewhere (see "FDA DTC Hearings: Snippets from Day 1").

DTC ads have come a long way since Day's study. When Pfizer came out with it's long Celebrex TV ad that focused almost exclusively on side effects (see "Celebrex Ad: Let's Dive Deeper").

In any case, practically all of the FDA's untitled and warning letters about DTC ads involve the lack of "fair balance" in ads. Some of these have even cited "disjointed imagery." So, in effect, the FDA already has a "ban" on this practice. What more do you want Jim?

Let's talk SERIOUS reform, shall we? The FDA, IMHO, should be given more power to sanction companies that violate its regulations -- like the power to issue fines and other penalties. The only power the FDA has now is the "nuclear option," which is to rescind a drug's marketing approval status. Not very useful as a stick for punishing minor advertising infractions!

#2: Reminder Ads
I think the boat has already sailed on this issue. Only one company I know of currently runs reminder ads -- Allergan, which runs Botox reminder ads, especially in print (see "PhRMA Intern vs. BOTOX!"). Most other companies have signed on to PhRMA's voluntary DTC guidelines, which prohibit these ads (but only on TV).

My opinion is that in cases where voluntary industry guidelines are working, there is no need for an extra layer of new government regulations. The REAL call for reform on this issue, therefore, is to call on PhRMA to add some teeth to its guidelines (eg, public disclosure of violations, fines, etc.) and to expand them to cover Internet and print advertising.

#3: Product Placement
Now we are getting away from advertising per se and into the realm of marketing/promotion. Nevertheless, I agree that this practice has to be reigned in. I don't believe, however, in making it illegal, which I suppose would take an act of Congress (ha!).

Drug product placements should be regulated, just like other DTC advertising is. For example, if a drug is promoted by a celebrity on a TV talk show and that celebrity has been paid to make the promotion, this fact should be revealed as the celebrity is speaking. You know, a little text notice at the bottom of the screen like car ads run when expert drivers are doing stunts in ads -- just in case some dope out there attempts to do the same thing.

I could go on and comment about the remaining 7 "reforms," but I do need to do some real work to earn a living. Besides, as I said in the beginning, these are reforms that are not specifically in the realm of advertising and are really reforms that the industry may need to make in its other activities. Many of these do not involve the FDA at all. So, calling upon the FDA to do all this reforming is really diverting attention away from the actual responsible parties.