'Round the Sphere: PDUFA, DTC and Pet Turtles Too!

The Food and Drug Administration Revitalization Act (S.1082) has been approved by Congress (see "Congress Expands FDA's Oversight On Drug Safety") and will soon be signed into law (you can read the entire bill here).

While Ed Silverman over at Pharmalot makes a big deal out the intense lobbying by advertising agencies and broadcasters to make sure the bill had no restrictions on DTC (see "Why Tougher DTC Restrictions Were Killed"), he overlooked the murky-water lobbyists who worked hard to ensure there were also no restrictions on the marketing and sales of pet turtles.

I refer, of course, to Title VII of the bill, which states that the FDA is prohibited from restricting the sale of turtles less than 10.2 centimeters in diameter.

The pet turtle industry feared a "turtle moratorium," however the Pet Turtle Advertising Council of America (PTACA) lobbied hard and long to have Title VII inserted into the bill. It would have been unseemly for turtle farmers, wholesalers, or other commercial retail sellers of pet turtles to do so directly.

For more on that, see "DTC Here to Stay; Pet Turtles Too!" over at Pharma Marketing Blog.

The WSJ Health Blog also covered this story (about the DTC advertisers' lobby, not the pet turtle lobby) -- see "Advertising Allies Turn Tide for Pharma."

PhRMA -- the US drug industry trade association -- was ecstatic about the bill's provision regarding the preview of broadcast TV ads, but was mysteriously silent about the turtles:

"...the legislation will enable FDA to hire additional employees to review broadcast drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated. It also will create strong incentives for companies to submit such advertisements to the agency before airing them, in accordance with PhRMA's Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs." (See "PhRMA Statement on Congressional Passage of PDUFA".)

NRx, of course, had more pressing news to report: ie, "Getting high on a can of Coke."

Hundreds of people every year are poisoned by pet turtles and we're talking about getting high from Coke?!!! Something's not right.

Finally, Mark Senak over at Eye On FDA, began his post ominously:

"As we all wait anxiously for Congress to do its job and actually produce legislation for signature, and as many FDA employees see their jobs hanging in the balance while awaiting PDUFA IV, some may wonder what it is all about and what is at stake."

Clearly, Mark is more worried about those poor FDA employees -- whom I calculate will be paid $231,481.48 per year to preview TV DTC ads (see my math here) -- than about those pet turtle owners who might have been denied licking the backs of their reptiles to get high!

Highlights from Pharma Marketing Blog

Web 2.0 Pharma Marketing Tricks for Dummies

An Innovative System for Communicating Drug Risks to Patients

Anyone who has tried reading a drug label knows how difficult it is to understand. It is especially difficult for consumers and patients to understand and evaluate the potential risks associated with the use of Rx drugs.

A new study in the September 10 issue of the Archives of Internal Medicine found multiple problems with drug labels. The authors suggest that one way to improve readability and patient understanding of labels is for FDA to initiate a national standard for their format and content -- much like it did with the "Nutrition Facts" labels required on food packaging.

In fact, the FDA recently invited food companies, trade groups, watchdog organizations, medical experts and its overseas counterparts to share how front-label symbols, like the "traffic light" system used in Britain, can improve public health. Shouldn't the FDA champion a similar system to rate risks on drug labels?

It may be a cold day in Hell before the FDA gets around to even suggesting such a system for Rx drug labels.

Thankfully, however, the private sector is jumping in to fill the void!

iGuard, an organization initially funded by Quintiles Transnational, a contract research organization that manages clinical trials for drug companies, has developed a color-coded drug risk rating system.

For more on this, see this post to Pharma Marketing Blog.

Do Pharma Marketers Need a Thick Skin or Will a Thick Skull Suffice?

Every Friday, I look forward to receiving "DTC In Perspective," Bob Ehrlich's weekly opinion piece.

Last Friday, Bob gave his "guidelines" for reviewing DTC (direct-to-consumer) marketing tactics and ads in an article called "DTC Critics." He suggested that because there will be many critics out there, including some who call for the firing of specific marketers, that "It takes a thicker skin to be a good marketer."

I respond to some of Bob' points, especially regarding DTC marketing ROI and whether or not DTC critics should include ROI estimates in their analysis.

Personally, I feel that some DTC marketers heads get too big in response to all the talk about how "creative" they are. This just might lead to skull thickening, which is known to squeeze your brains and not allow any NEW ideas in! I can understand developing a thick skin, but I have no patience with thick skulls.

For more on this, see this post to Pharma Marketing Blog.

Meet Dr. Andree Bates, Marketing ROI Expert

Dr. Andree K. Bates, President, Eularis, is a leading expert in pharmaceutical marketing analytics. Her career has encompassed academic, clinical and pharmaceutical positions around the globe, and she has gained worldwide recognition within the healthcare industry for ROI and marketing effectiveness measures.

I am very pleased that Dr. Bates was my guest on a recent Pharma Marketing Talk podcast:

You Want Marketing ROI? You're Not Ready to Measure ROI!
If You Can't Define It, You Can't Measure It!
Listen to the audio archive here

For more on this, see this post to Pharma Marketing Blog.

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, blame "overzealous vendors."

Overzealous vendors or not, pharmaceutical marketers 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.

For more on this, see this post to Pharma Marketing Blog.

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

Desperate times call for desperate measures.

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 are a couple of problems with this campaign..

For more on this, see this post to Pharma Marketing Blog.

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."

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.

For more on this, see this post to Pharma Marketing Blog.

Blogs Bob Ehrlich Reads

Who is Bob Ehrlich and why do I care what blogs he reads?

Ehrlich is Chairman of DTC Perspectives, which publishes the trade publication, DTC Perspectives Magazine, and is host to several DTC industry conferences. Ehrlich also writes a weekly OpEd email piece called DTC in Perspective.

Back in May, Bob was a guest on my Pharma Marketing Talk podcast where the subject was "Blogs vs. DTC: What's Best for Consumers?" You can listen to the audio archive of that podcast here.

Of course, Bob and I have had our differences (see, for example, "Mack and Meyer Clash with Publisher Over "Journalistic Integrity""), but we've agreed to disagree and remain cordial and frequently exchange opinions by private email.

Whatever our differences are, we are avid readers of each others' work and this week Bob reveals that my blog, Pharma Marketing Blog, is one of the three pharmaceutical blogs that he reads on a regular basis. The three are:

1. Pharma Marketing Blog
2. Pharmalot
3. Peter Rost (not sure if he reads Question Authority or NRx)

I note with interest that Ed Silverman (Pharmalot) and Peter Rost (NRx) will be the star blogger panelists at the DTC in the Age of Innovation Conference (October 24-25, 2007) hosted by Ehrlich's company.

Ehrlich had this to say of me and my blog:

"I am always interested to know what John Mack has to say. His Pharma Marketing blog is usually fun to read even when it annoys me. John always likes to ruffle feathers but I usually appreciate his humor, even when the feathers he ruffles are mine, which he does frequently. He will review controversial DTC ads or new tactics used by marketers. Few will get a good review but he is worth listening to because he could just right sometimes."

Thanks for the kind comments, Bob!

One thing regarding my review of DTC ads; ie, "Few will get a good review ..."

As I have said before (eg, "I'm Non-Objective and Proud of It" and "Trade Publications Must Be More than Drug Industry Cheerleaders!"), the field is crowded with publishers and pharma marketing experts that never have a NEGATIVE thing to say about DTC or other types of pharmaceutical marketing. Their reviews are ALWAYS good!

I believe that there is a great unmet need out there for constructive criticism, which is what I strive for over at Pharma Marketing Blog.

You can read Bob's weekly e-Column OpEd piece here.

While I enjoy Bob's weekly commentary, I find it difficult to cite. The commentary is sent via opt-in e-mail, but the Web site that I linked to above is not updated for several days afterward. I wish that Bob would start a blog instead. That way, he can join the conversation here in the Pharma Blogosphere!

Health Populi: Welcome to the Pharma Blogosphere!

My friend Jane Sarasohn-Kahn, a health economist and management consultant, has just started a new blog called Health Populi.

That's Jane on the left, also shown with her mom in 1961!

Here's the mission statement for Health Populi:

"Welcome to Health Populi. As a health economist, I believe that health is a person’s most valuable asset. My mother and father taught me that fundamental value. My mother, Polly, was diagnosed with Hodgkin’s lymphoma in 1971. There was no Internet to consult; there was a doctor, who fortuitously was just the sort to partner with a patient and be open to the latest clinical research. There was also a librarian, a close friend of Polly’s, who helped her dig up health information via the good old Dewey Decimal System, microfiche, and the unwieldy tomes of Index Medicus. Two nutrition books informed Polly’s approach to personal health management: Adele Davis’s Let’s Eat Right to Keep Fit and Let’s Get Well. Empowered by knowledge, trust in a good doctor, and buoyed by the abundant love of family and friends, my mother beat a six-month death sentence and lived an additional 7 years beyond the doctors’ original prognosis.

After her death, I made the personal, professional, and studied health economics at the University of Michigan. I’ve spent the last two decades advising with the vast array of health care stakeholders in the U.S. and Europe – providers, payers, technology companies, pharmaceutical manufacturers, financial services, and other players in the health care market.

In this blog, I will share my multi-faceted perspectives on health care. In the new wave of transparency in American health care, I seek to shed light. I want to help move along the dialogue that Americans – not just politicians and pundits, but the bulk of Americans living and working outside of legislatures -- must have regarding how to honestly, openly and boldly confront the challenges facing U.S. health care."

Jane, I wish you luck!

First Ever Perfect Execution of YouTube "User-Generated" Video Trick!

Novartis is sponsoring a contest -- FluFlix Video Contest -- that entices young people (over 18 years of age) to submit videos to YouTube that show how they "feel about influenza, commonly known as the flu, and how it can affect [their] everyday [lives]."

I reported on this last week and noted how this was an attempt to perform a perfect execution of the YouTube "User-Generated" Video Trick (see "Novartis Attempts Perfect Execution of Web 2.0 Trick!").

At that time, the "Official Contest Rules" were not available and I speculated that that contestants would be required to sign over their rights to their videos to Novartis who would then incorporate some of them (or clips from the videos) into branded TV commercials for Fluvirin, Novratis' flu vaccine.

Now the Contest Rules are available and they vindicate both parts of my prediction.

Read more about this over at Pharma Marketing Blog: "My Prediction Vindicated: FluFlix Contest Entrants Will Sign Over Rights to Their Videos to Novartis for Use in Product Commercials".

Learn about more Web 2.0 Pharma Marketing Tricks here.

Hmmm...Ah! I Love the Smell of Pharma Blogosphere in the Morning!

"What do you know about surfing major? You're from goddamn New Jersey!"

We former New Yorkers living in the Philly area get a kick out locals who brag about "going down the shore," by which they mean the New Jersey shore. When we say the beaches in New York are better than those in Jersey, they stare at us blankly and exclaim, "New York has beaches?" Duh!

New York or New Jersey, surfing there sucks!

But I love surfing here in the Pharma Blogosphere, especially in the morning!

First, I look over there in the right hand to see what's going on at Pharma Marketing Blog and Pharma Marketing podcastville.

At Pharma Marketing Blog, for example, you can Meet Dr. Andree Bates, Marketing ROI Expert. Dr. Bates' glamour shot appears on the left.

Then I try CafePharma's Pharmagather, which tells who has posted what most recently. Sometimes, however, this unnerves me because I get the urge to respond to the first item on the list although it may not be the best.

That's when I switch to PharmaCentral PageFlake, where I can browse through many posts on a blog-by-blog basis rather than on a FILO basis the way Pharmagather is set up.

My personal favorite blogs are arranged alphabetically in the Inner Planet list on the right. I go to that list when I want to check up on a specific blog.

Anyway, that's my morning routine in case you were interested!

'Round the Sphere: New Media Tricks, Old Media Mystery, News Media Morons

It's all about the media this week 'round the old Pharma Blogosphere! At least on my narrow radar screen.

I started out with a post here about Web 2.0 Tricks for Pharma Marketers that I plan to reveal at THE Pharma Marketing Event on September 19 at the fabulous Park Hyatt at the Bellevue in Center City Philadelphia, PA (more info about that conference can be found here).

Peter Rost over at NRx graciously picked this up in his post "How to use the web to fool the FDA." I should note -- and I'm sure Peter is well aware of this -- that it is very easy to "fool" the FDA these days, especially when they are not even looking! Any hand can be quicker than the FDA's eyes! No magic there!

I also picked up from another of Rost's posts Novartis' attempt at a perfect execution of the YouTube "User-Generated" Video Trick (see "Novartis Attempts Perfect Execution of Web 2.0 Trick!"). Suffice it to say that this involves a contest. Both Rost and I, however, could not access the Official Rules (go ahead, click it and see what you get -- the dreaded "404" error).

I called Novartis and they were not aware of the contest..."Flu what-did-you-say?" They promised to investigate and get back to me, but I'm not holding my breath.

Meanwhile, in my post, I surmise that Novartis will purchase the copyright to winning videos and incorporate them into TV DTC ads for Fluvirin, its flu vaccine.

My friend Fard Johnmar over at HealthcareVOX says "You Can Run, But You Can't Hide" when it comes to performing tricks in the Web 2.0 WILD WILD WEST. He cited Abbott getting caught attempting the Wikipedia Sleight-of-Hand Edit Trick. However, if pharmaceutical marketers were to follow my directions, I am sure they can run AND hide! Come hear my presentation and learn how to flawlessly execute this trick is all I am saying.

Fard also was kind enough to send me a New Social Media Marketing Framework White Paper he co-authored with TNS Media Intelligence/Cymfony.

"Pharmaceutical companies are missing a tremendous learning and consumer engagement opportunity with social media because they are uncertain about the FDA's position on this type of marketing," said TNS Media Intelligence/Cymfony Chief Marketing Officer Jim Nail. "Our framework gives their marketing, legal and regulatory groups a common ground to design a social media strategy."

Framewok, Shramework! Just reveal the secrets! That's what I promise to do in my presentation and soon-to-be-published "Compendium of Web 2.0 Tricks for the Pharmaceutical Marketer: Secrets of the Masters Revealed. Everything that You Can Get Away With and Nothing that You Can’t Get Away With!"

Let's not quibble about "one click" or "two clicks" as the "rule." There are NO rules except DON'T GET CAUGHT by being STUPID like Abbott!

OK, enough about New Media. What about Old Media?

Print DTC ads in magazines is something we don't write about often. It's just not very glamorous or as funny as TV DTC ads!

This week, however, I noticed a mysterious print DTC ad for GSK's Veramyst in Time Magazine (see "What's Up with the Veramyst 'Brief Summary' Print Ad?"). It's like a mystery I cannot solve! Someone please tell me what's going on!

One thing that's not a mystery are moron main stream "journalists" who repeat practically verbatim the stuff pharma PR wonks hand them. Rost pointed this out in his recent post, "Healthcare journalists are morons." [Rost is really on a Roll with his pharma-related posts lately!]

The story at the heart of this was about a Pfizer "study" that attempted to "generate the hypothesis" that you are at a higher risk of DEATH if you stop taking Pfizer's Lipitor and switched to Merck's generic Zocor!

Drat! I should have used the "hypothesis generating" weasel statement when I released the results of the Pharma Blogosphere Reader Survey! D'Oh!

Of course, I've known for a long time that health journalists were "marketers in PR clothes;" see, for example, "Marketing Disguised as PR" and "PR Marketing: Mystery Wrapped in a Riddle."

But health journalists are NOT morons. Far from it! They are part of the pharmaceutical industry's PR/Marketing team and THEY ARE UNREGULATED TO BOOT. Also, many health journalists end up working in Big Pharma corporate communications. Ray Jordan, J&J PR Veep, for example, started out as a journalist (see "Introducing Ray Jordan, J&J PR Veep, Winemaker!")

Web 2.0 Tricks for Pharma Marketers to Be Revealed September 19 in Philadelphia

After years of advising pharmaceutical marketers to avoid shady online practices, especially when using Web 2.0 tools, I have decided that my presentations, blog postings, and articles are falling on deaf ears.

What marketers really want to know is how to get away with it -- how to flawlessly perform the "Tricks of the Trade" as they say.

To satisfy that need, I am developing the

"Compendium of Web 2.0 Tricks for the Pharmaceutical Marketer: Secrets of the Masters Revealed. Everything that You Can Get Away With and Nothing that You Can’t Get Away With!"

This compendium will be available in October, 2007.

Meanwhile, I invite everyone to attend my presentation on this topic at the

THE Pharmaceutical Marketing Event
September 19, 2007 in Philadelphia, PA

This presentation will give precise instructions on how to perform the following tricks:

• Trick #1: Google "BAdwords"
• Trick #2: Posing as a Consumer on Social Networks
• Trick #3: Wikipedia Sleight-of-Hand Edit
• Trick #4: YouTube "Consumer-Generated" Video

If you cannot attend my presentation in person at 11:30 AM during the aforementioned event, you will be able to download my presentation afterward -- available only to subscribers of Pharma Marketing News. If you are not already a subscriber, SUBSCRIBE ONLINE NOW! It's FREE!

Or you can purchase the Compendium, which will include the secrets for performing these tricks and others. It will also include background collected from posts to Pharma Markerting Blog and articles published in Pharma Marketing News.

Or you can listen to the following podcast:

Gaming Web 2.0 Sites, Bad Google Adwords, Wiki Edits, Phony Meta Tags, and Other Ways to Get Around the Rules in Online Marketing.

• Guest: Jeffrey Light, Chairman, Patients not Patents, Inc.
• Live Podcast Date: Thursday, September 6, 2007, 2 PM Eastern US time
• Listen Live (or to the audio archive after the show) via the Pharma Marketing Talk Channel page.

DISCLAIMER
The "tricks of the trade" revealed in this presentation and compendium are for your entertainment only. DO NOT try these tricks at home or in your office without proper instructions!

You hereby acknowledge that any reliance upon any tricks or information herein shall be at your sole risk. The author reserves the right, at his sole discretion and without any obligation, to make improvements to, or correct any error or omissions in any portion of this presentation.

The tricks and information herein are provided by the author on an "as is" basis, and the author expressly disclaims any and all warranties, express or implied, including without limitation warranties of merchantability and fitness for a particular purpose, with respect to the tricks or the information herein. In no event shall the author be liable for any direct, indirect, incidental, punitive, or consequential damages of any kind whatsoever with respect to the “tricks” or the information herein.