Thursday, September 27, 2007

A Pill, a Plan, a Profit? -- Chantix!

Slow and steady wins the race. That is the message of the new Chantix TV DTC (direct to consumer) ads that feature a race between a tortoise and a hare.

The Chantix tortoise is not related to the Comcastic "Slowsky's" shown in this YouTube video (one of my favorite TV commercials!):

BTW, the hare on the Chantix TV ad is a scrawny, reddish -- devilish, may one say? -- hare; not a cute cuddly rabbit like the Eveready bunny!

Yet, strange to say, this devilish-looking hare does NOT make it to the Chantix Web site, which features a much more ordinary and benign-looking RABBIT (see image on left, click to enlarge).

All this imagery serves a purpose -- the Chantix marketers are telling us that quitting smoking is long process requiring a steady, tortoise-like approach.

According to the Web site:

"Quitting smoking is a challenge that is not for sprinters. Our steady, step-by-step approach may help you quit smoking. And as the classic fable has taught us, a steady approach may be the wisest approach. In fact, studies show that 44% reached their quitting goal at the end of 12 weeks on CHANTIX (vs. 18% on placebo). "

According to a November, 2006 Wall Street Journal article, "Pfizer has ... adopted a measured marketing approach because it knows that older antismoking medicines like nicotine gum boomed and then busted. Sales surged as people rushed for a quick fix for their habits but fell amid disappointment resulting from 'unrealistic expectations' of success, Ian Read, president of pharmaceuticals at Pfizer, remarked in a call with analysts..."

Unrealistic Expectations
It seems these days that several drug brands are grappling with "unrealistic expectations." Alli, an OTC weight-loss, drug employs a similar approach. You can read the Alli blog post post "Unrealistic weight loss goals: who's responsible?" and learn that the"Number of pounds lost should not be the only yardstick of success." Translation: despite claims made on the discussion board sponsored by GSK -- click here -- you won't lose 110 lbs taking Alli/Xenical.

With smoking cessation products, however, you either succeed or you don't. But that kind of success is not what the Chantix marketers focus on. The only claim made is what percentage of people "quit" smoking during a 12-week period. Not much data beyond the 12 weeks is reported.

That's the Pill side of the equation. Now, add to that the Plan; ie, the GETQUIT™ 52-week support plan, which includes:
  • A step-by-step guide for preparing to quit
  • A personalized Web site with easy-to-use tools that track your progress
  • Support and advice designed to help you learn how to stay quit
  • Support for up to a full year
  • A toll-free support hotline to speak with a GETQUIT coach
I discussed this program before -- see "Chantix: Opportunity for Social Marketing Lost?" -- and I think I signed up for it.

Unfortunately, there were technical difficulties logging back into the program, so I guess *I'll have to do without the plan for now.

P.S. Do only life-style drugs like Chantix and Alli deserve a Support Plan developed by experts? According to FDA guidelines, many drugs require lifestyle changes to achieve maximum effect -- at least that's what the FDA would like drug marketers to say in their ads.

Shouldn't Pfizer include a 52-week cholesterol-lowering support plan with Lipitor? Mostly, what they offer is more information about Lipitor and cholesterol-lowering factoids -- nothing that would really qualify as a "plan developed by behavioral experts."

Wednesday, September 26, 2007

POE: DTC Forevermore

Once upon a Nightly News show dreary, while I pondered, weak and weary,

Over many a quagmire and unending war,

While I nodded, nearly napping, suddenly there came a drug ad,

As of someone violently sneezing, wheezing, or erectile poor.

"'Tis some me-too drug," I muttered, "for the erectile poor;

Only this, and nothing more."

Not THAT Poe!
It's time again for the POE awards! No, not the Edgar Allan Poe awards but the Perspectives on Excellence Awards -- a yearly event sponsored by DTC Perspectives (see "DTC Perspectives Magazine Announces Finalists for the POEs Awards").

I reviewed the POE winners of last year after the fact (see "Awards: The Good, The Bad, The Ugly"), but this year I'd like to review the contenders and give readers an opportunity to vote before the winners are announced at the DTC in the Age of Innovation Conference, which I hope to attend.
NOTE: The conference link above will take you to the conference discussion thread I set up at the Forums at Pharma Marketing Network. Within that thread, I solicit comments on the POE awards. You are welcome to comment here or there, but there is a much better social networking opportunity should you care to take advantage of it (for more about that, see "An Online Community of Our Own").
There are several POE award categories, but I'd like to focus on the "Most Innovative DTC Campaign" category. The finalists are...
  • Celebrex
  • Gardasil
  • Rozerem
  • Tamiflu
  • Vytorin
Except for Tamiflu, I have written about all of these campaigns in this blog. On that basis alone, I don't give Tamiflu much of a chance of winning. Maybe you disagree. Let me hear about it!

What does "Innovative" mean in the context of DTC advertising? I'm not sure how the POE judges define innovation, but for me innovation means more than something new -- it means a new way of doing things. It's more strategic than tactical. Using weird imagery like Abe Lincoln and a beaver jumping rope or hanging out together playing chess is just a gimmicky tactic. You really can't say it opened up a new way of thinking about DTC advertising.

That's why I wouldn't vote for Rozerem. I am obviously dismayed that Rozerem makes the list every year-- last year it came in third (Bronze). You can find all the posts I've written about the Rozerem DTC campaign by clicking here.

The new Celebrex DTC ad, on the other hand, did offer a new way of thinking about presenting side effect information and getting beyond that to the benefit message (see "Celebrex Ad: Let's Dive Deeper" and "Risk-First DTC: A Tactic to Overcome Resistance"). I think, therefore, that the Celebrex campaign should win the Gold or the Silver.

The Gardasil campaign illustrated an interesting connection between advertising and PR. When I first saw the TV ads for Gardasil, it gave me a sense that, finally, here was a product we should all get behind. At the time, there was a lot of opposition to vaccination against a sexually-transmitted disease from the religious right. I gave Merck many kudos for courageously defying that sentiment by bring young woman -- teenagers -- into the message of its ads.

What destroyed the goodwill elicited by the ad was the subsequent exposure of Merck's behind-the-scenes campaign to make vaccination mandatory (see "Does Merck Need a Vaccine for Bad PR?"). I'm not in favor of mandatory vaccination in this case.

No matter how unsavory Merck's lobbying activity was, it did not seem to hurt Gardasil sales (see "Mandatory Vaccination Controversy Did Not Hurt Gardasil Sales!").

After all is said and done, I still put the Gardasil campaign high up on my list of contenders for the prize.

Vytorin. What can I say? This campaign may be the longest running DTC campaign in history. It's getting boring and weird (see "Vytorin Ads Are Getting Old -- and Disturbing!").

Vytorin, like Rozerem, is a serial POE award contender in the "Most Innovative" category. Last year, it came in first (Gold winner). So, I don't think the Academy -- the POE judges are actually called the "Academy of Excellence"! -- will put it at the top of the heap this year.

But enough of what I think! It's time for you to vote:

Which is the most INNOVATIVE DTC campaign?

Friday, September 21, 2007

DTC Here to Stay; 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).

Two provisions -- or lack thereof -- of this law stood out to me: (1) a one- or two-year moratorium on direct-to-consumer (DTC) ads for all new drugs did not make it into the bill, and (2) a provision prohibiting the FDA from restricting the sale of turtles less than 10.2 centimeters in diameter as a pet DID make it into the bill (Title VII - Domestic Pet Turtle Market Access; Section 703).

I am not a pet turtle safety expert, but I learned from a quick blog search (here) that pet turtles can poison you!

Who am I to question how or why the turtle provision made it into a drug safety bill? It's been rumored, however, that 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 (see here).

But enough about the nation's emerging pet turtle safety problem. Let's focus on DTC and what new powers over DTC S.1082 gives to the FDA.

It's Mostly About the Money
Firstly, FDA gets new fees for reviewing DTC ads before they are aired on TV. See "PDUFA Payola!" for more about that. According to the S.1082: "There are authorized to be appropriated for fees under this section not less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 2011, and 2012..."

In a previous post ("Where's DDMAC's Head At?") I showed a chart of the number of DTC materials submitted to the FDA each year. In 2005 about 4,600 print and TV DTC pieces were submitted for review. Maybe 2,000 were TV-related. If FDA gets more money to review TV ads, this could increase to 3,000. The fee per piece (eg., storyboard for one ad) works out to about $2,000. This seems like a lot of money to review a single piece. I could do it for $1,000! If FDA were to hire me, therefore, it could pocket about $1,000 for every ad it previewed.

According to an Advertising Age article, "the legislation's main effect is to boost the number of people at the FDA who will review ads." FDA has said that the $6+ million would be used to pay an additional 27 staffers. That works out to about $231,481.48 per person per year. Where's the job application? I'll sign up today.

Secondly, it's about the fines. According to the Advertising Age article cited above, "[the legislation] also gives the FDA new authority to fine advertisers up to $250,000 a day for continuing to run any ads challenged as misleading and up to $500,000 a day for a second instance within three years."

On first reading of the above, it would seem that the drug industry did not get what it wanted; ie, a get of jail free card for ads pre-approved by the FDA. That is, the industry wanted any pre-approved ads to be exempt from fines or warning letters after the fact.

But let's dive deeper and actually read the legislation, which states:

"(B) Upon the request of the applicant to be assessed a civil penalty, the Secretary, in determining the amount of a civil penalty, shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors: Whether the applicant submitted the advertisement for prereview if required under section 505(o)(5)(D)."


"Subject to subparagraph (B), no applicant shall be required to pay a civil penalty under paragraph (1) if the applicant submitted the advertisement to the Secretary and disseminated such advertisement after incorporating any comment received from the Secretary."

Therefore, the industry DID get a "Get Out of Jail Free" card after all!

Thursday, September 20, 2007

Web 2.0 Pharma Marketing Tricks for Dummies

That's the title of the book I plan to write based on a presentation I gave yesterday to an audience of about 30 people at IIRUSA's "THE Pharmaceutical Marketing Event." See "Web 2.0 Tricks for Pharma Marketers to Be Revealed September 19 in Philadelphia" for more information about this presentation.

As a reminder, I revealed the secret to the perfect execution of the following four 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

I've written comments about these tricks in this blog many times. You can search for the relevant posts.

The premise is this: pharmaceutical marketers are dummies/babes in the woods/etc. when it comes to pulling the wool over our eyes using Web 2.0 technologies like blogs, wikis, and discussion forums. They need, therefore, someone like me to explain to them step-by-step how to do these tricks without messing them up and getting caught by the FDA, bloggers like me, or the press.

The truth of the matter is that anyone can perform these tricks in broad virtual daylight and get away with it. There's really nothing "illegal" about it. It's just harmless fun.

Although the audience was small -- about 35 people -- I was a bit nervous because most of them worked for pharmaceutical companies and some for companies that I would be talking about. I should have performed my "shoe" trick to start off and lighten the mood (the trick involves guessing where someone in the audience got their shoes -- want me to guess where you got the shoes your wearing?).

Google "BAdwords"
Let's revisit the Google "BAdwords" Trick, which got the most feedback from the audience yesterday.

I first presented the story behind this trick in the classic posts "The Girl from Google" and "Lunesta, Google, and BAdwords."

Here's the "BAdwords" trick I presented:

What consumers online see (click it to enlarge and read):

This ad, IMHO, is "tricky" for several reasons:
  1. Improper indication: Enbrel is specifically approved for the treatment of “moderate-to-severe plaque psoriasis,” which is much more specific than "psoriasis”
  2. Lacks fair balance
  3. No generic name (etanercept); merely a technical violation
The real "trick" is getting away with broadening the approved indication of the drug by implying that it is approved for all forms of psoriasis. The other points are really moot since the FDA has never cited other Google adwords that used these "tricks."

But the ultimate trick is making sure the FDA does not see the tricky version of the ad, but another, more acceptable, version.

What the FDA sees (if it were looking):

This ad is less "tricky" and probably will pass muster with the FDA because:
  1. Proper indication is given
  2. Still Lacks fair balance, but the argument can be made that this ad is part of a larger piece of information (product web site accessible in one click via link) that is NOT separate from the ad (the infamous “one-click rule” attributable to the FDA)
  3. Still has no generic name: But that can be forgiven in a URL
The Secret to Performing This Trick
It is quite easy to add, delete, or edit Google adwords instantly and never leave a trail! Well, there might be a trail, but only Google will have that information and it would probably take a court order to get it.

All you -- or any low-paid summer intern that you hire -- have to do is create 2 groups of adwords: one that is "violative" (ie, the trick ad) and one that is not. If your trick ad is outed by a blogger or reported to the FDA, instantly switch to the legit adword group! No one, least of all FDA, will be the wiser!

This trick requires some attention, but as I said, any summer intern can handle it! It's CHEAP TOO!

Why be a "Mister Nice Guy" when you can be a "Mean Hombre?" Learn the secrets to the perfect execution of these Web 2.0 tricks, which will be revealed in an article in the upcoming September issue of Pharma Marketing News

You can get this issue by subscribing. It's simple, just click here to subscribe. The FREE subscription is made possible by email ads.

You can also buy the reprint after publication here.

Tuesday, September 18, 2007

Risk-First DTC: A Tactic to Overcome Resistance

First there was Risk-Free DTC (see "DTC without the Risk"). Now there is Risk-First DTC!

Before I get into that, there's a related story I'd like to review about how risk is communicated in the US vs. the UK.

Just when I thought the UK can do no wrong when it comes to regulating prescription drugs, I learn that its regulatory agency -- the Medicines and Healthcare products Regulatory Agency (MHRA) -- may be doing a worse job than the FDA warning citizens about emerging drug risks (see article here).
The issue of reporting drug risks in the US will be the subject of a Pharma Marketing Talk podcast this Thursday (see "An Innovative System for Communicating Drug Risks to Patients").
"The concern is that, after such high-profile controversies as Vioxx and Avandia, the UK watchdog lacks initiative in encouraging doctors to file adverse event reports and most of its budget is earmarked for reviewing drugs (if this sounds familiar to American ears, well…)," says Ed Silverman over at Pharmalot.

The example cited in the article involves Avandia, which, after review by the FDA, will soon carry a black box warning that it could cause cardiovascular problems.

In the UK, on the other hand, "the only response of our drug watchdog," claims the article, "has been to say that leaflets that come with the drug already contain warnings about heart problems."

On the surface, this sounds that the US FDA is more proactive than the UK drug agency. But only if the FDA-required "black box" warning really is an effective warning system.

The black box certainly is not seen by consumers. I mean, when was the last time you got the package insert (official FDA drug label) when you picked up your prescription?

Yes, physicians see it, if THEY read the label. But if physicians in the UK read their Avandia label, they would get the same information as US physicians.

Besides, what with aggressive detailing of physicians by Avandia salespeople, I am sure the black box is a mere pea under the extra-firm sales mattress -- hardly noticeable to the rank and file physician!

What's needed is Direct-to-Consumer drug warnings.

This is more important, IMHO, than warnings issued to physicians who may. let us say, have certain conflicts of interest that may unduly influence their prescribing habits.

It's interesting that Patrick Clinton, Editor of Pharmaceutical Executive Magazine, picked up on this topic in a recent editorial entitled "What Do You Say?" "I'm thinking of how companies and FDA should react to what we might as well call the 'Vioxx [or Avandia] moment'," says Patrick. "What should we say, what should we do, when the Vioxx moment comes to call?"

Here's his answer:
"I wouldn't want to see us go to the Canadian system of "pull it from the market first and ask questions later." But the current system is obviously not aggressive enough. I suspect the answer will include both a standard format for reporting safety signals to the public—one that assesses the validity of the evidence and provides a realistic estimate of how long it will take to get more—and perhaps even some sort of informed-consent procedure. That would be a burden to physicians, patients, and pharma alike. It would certainly frighten some patients out of taking their drugs and some doctors out of prescribing them. But that may turn out to be the price of trust.

The execution may prove difficult, but the goal is simplicity itself. No patient should ever be able to say of a risky drug, 'You knew, and you didn't tell me.' For everyone's sake, that must be utterly nonnegotiable."
In other words, TELL THE PATIENT!

Rule: If Black Box, No DTC
It's interesting to note that whenever FDA slaps a "black box" warning on a drug label, that's usually the end of direct-to-consumer communication (aka, advertising). The drug company goes dark on the subject of its drug as far as the public is concerned.

The FDA was going to launch a website where consumers could find emerging drug risk information, but it nixed that idea in the bud (see "Drug Safety - A Mere Asterisk to the FDA").

Risk-First DTC
There was one notable exception to the "If Black Box, No DTC" rule of thumb: the recent 150-second Celebrex DTC TV ad (see "The New Celebrex TV Ad: What Did You Learn?" and "Celebrex Ad: Let's Dive Deeper").

Although this ad has been criticised for mentioning "death" several times, an article in PE Magazine suggested that this "risk-first DTC" appears to be a new tactic -- "to persuade the public about a drug's usefulness ... acknowledging the negative allows the product to gain credibility, mitigates resistance and counterarguing, and permits information that would normally 'hit a brick wall' to be viewed in a credible context."

Sigh! In other words, communicating risk to consumers in DTC is really a tactic to overcome resistance and get to the core benefit message.

Thursday, September 13, 2007

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 (see "FDA Considers Color Code for Food Labels, But Not for 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 (see image at left; click to enlarge).

iGuard's Risk Rating system assigns color-coded risk labels to drugs to communicate the risk of developing serious side effects. This system is not intended for drug labels, however. It is an online solution that patients can customize for their own use depending on the drugs they are taking.

Dr. Hugo Stephenson, Founder and President of iGuard and the person responsible for the overall vision of the iGuard service and business, will be my guest next week on my weekly Pharma Marketing Talk LIVE podcast:

I invite you to listen in to my conversation with Dr. Hugo Stephenson at next Thursday's
Pharma Marketing Talk Podcast

(listen live or the the audio archive here):

An Innovative System for Communicating Drug Risks to Patients
A Color-coded Risk Rating System That Delivers Personal Safety Alerts
Airs LIVE, Thursday, September 20, at 2 PM Eastern US time.
See more information here.


Before the show, I'd like to get comments and questions from readers that I can convey to Dr. Stephenson during my conversation with him. You can submit your comments here on this blog, or you can participate in the discussion thread I have set up over at the Forums at Pharma Marketing Network. Hope to see you there!

Here are some comments I have already received to my previous post on the topic of color-coded drug risk labels:

The Continuity Police said...

The issue that I see with your traffic light system for pharma is that there is no constant for a given chemical's safety within a particular person's extant chemistry. Which is to say, there are few to no 'green light' across the board cases.

Just as a quick example, I imagine that Aspirin might rate a green light - only my wife is allergic and that green light med would cause her great consternation or even grave illness. Similarly many medications are reactive, produce compound effects within the body, or otherwise alter the chemistry of a body in ways that are more complex than any green-yellow-red system could convey accurately.

I see that the idea is to help people understand risk better, but I think the method you posit introduces risk of a far mroe insidious variety. Better to just promote literacy and ask that people try to - you know - pay attention to what they put in their bodies. Try asking a doctor or reading a book, it's much more informative than a misleading EZ-chart.

Cary said...

I think it is a great idea, and like you said, Obviously, if consumers need help understanding food labels, they need much more help understanding drug labels.

The previous commenter made the point that "no constant for a given chemical's safety within a particular person's extant chemistry. Which is to say, there are few to no 'green light' across the board cases." -This is true, but is just a general guideline much like the system the FDA has implemented for food labels. It is a warning that would alert users in which a large group who has suffered adverse events. It may or may not affect or pertain to the individual, but it will at least urge them to ask there doctor and investigate the matter.

Tuesday, September 11, 2007

My Prediction Vindicated: FluFlix Contest Entrants Will Sign Over Rights to Their Videos to Novartis for Use in Product Commercials

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.

Part of the Official Rules are shown at the left (click to enlarge and read). They are simply too long to reproduce in their entirety here. You can see all the rules on the FluSource web site.

It turns out that I was absolutely correct about who will own the rights to these videos. In fact, not only will Novartis own the rights to the winning videos, it will own the rights to ALL videos submitted for consideration! Here's the relevant language in the "Rules":

RULE 12: Effect of Uploading an Entry: By uploading an Entry, each Entrant irrevocably: (a) grants Sponsor and its parents, subsidiaries, affiliates, legal representatives, assigns, agents, contractors and licensees (collectively, the "Promotion Parties") the unconditional, perpetual and irrevocable right and license to reproduce, encode, edit, store, record, distribute, make derivative works of, merchandise, license, sublicense, adapt and/or modify, copy, transmit, publish, post, broadcast, display, publicly perform, exhibit, and/or otherwise use or reuse (without limitation as to when or to the number of times used), the Entry and any part thereof, including, without limitation, the recording and the performances contained therein (in each case, as submitted or as edited/modified in any way by Sponsor, in its sole discretion), as well as to use the Entrant's name, Likeness, and/or statements regarding his or her participation in the Contest (with or without using the Entrant's name) in any and all media without limitation as to time or territory, and without compensation or approval from the Entrant or any other party, and (b) agrees not to grant any license to use any of his or her Entries (in whole or in part) or any component thereof for the benefit of any of Sponsor's competitors, as determined by Sponsor in its sole discretion. Each Entrant waives and renounces all intellectual property rights, privacy/publicity rights or other legal or moral rights that might preclude Sponsor's use of the Entry, and agrees not to sue or assert any claim against Sponsor for the use of the Entrant's Entry or Likeness or statements.
In addition to that, according to RULE #15, each entrant must "participate in interviews with Sponsor; permit Sponsor to use the Entrant's winning Entry, name, Likeness, hometown, voice, biographical information and excerpts from the interviews conducted with the Entrant...for purposes of advertising, promotion and publicity of Sponsor and its products."

This confirms the second part of my prediction that these videos may be used in product advertising, which, if done, would close the circle on the first-ever perfect execution of the YouTube "User-Generated" Video Trick!

For more Web 2.0 pharma marketing tricks that you too can master, see "Web 2.0 Tricks for Pharma Marketers to Be Revealed September 19 in Philadelphia."

FDA Considers Color Code for Food Labels, But Not for Drug Labels

The "Food" part of the Food and Drug Administration (aka, FDA) lately seems more interested in promoting public health and safety than the "Drug" part.

According to an AP story, "On Monday, the Food and Drug Administration [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" (see "FDA Asks Groups to Consider Food Labels").

The "Traffic Light" system adopted by the UK Food Standards Agency that the FDA is talking about is illustrated on the left.

Of course, nothing may come of this, just as nothing came of FDA's promise in 2004 for a "Drug Watch" site that would make it easier for consumers to find emerging safety information about the drugs they are consuming (read FDA's promise here: "FDA Drug Watch Site Guidelines"; then read about its promise reneged here: "Drug Safety - A Mere Asterisk to the FDA").

After the FDA's initial promise, when it asked the public for comments (that it promptly ignored, except for the comments against the idea from the drug industry and its lobbying/PR minions), I submitted a proposal that is very similar to the "Traffic Light" system the UK uses for food labels (see "Proposal for a Drug Risk Advisory System").

My system was based on the Homeland Security color-coded risk system, which was popular back then (see image at right).

I think such a color-coded system would be helpful in communicating drug risk information to the public. It gives a high-level summary of risk that even health jargon "illiterate" consumers can understand at a glance. Unlike other proposed symbols for drug risk, ie, the black triangle, a color-coded scheme allows some nuance about the level of risk.

If you are interested, you can read more about my idea and see my comments to the FDA here: "Proposal for a Drug Risk Advisory System."

Obviously, if consumers need help understanding food labels, they need much more help understanding drug labels!

Therefore, it would be nice if the "Drug" part of the FDA "invited" drug companies, medical experts, consumer advocacy groups and watchdogs (woof!) to consider my color-coded drug risk alert system or a system modeled after the UK "Traffic Light" scheme for drugs.

Yeah, that could happen! I guess we are stuck with the antiquated "Black Box."

Monday, September 10, 2007

A Better Viva Viagra Ad

Peter Rost challenged me -- and other readers of his NRx blog -- this morning to come up with a "better pharmaceutical ad" than the one he showcased (see "Have you ever seen a better pharmaceutical ad?").

Did you see this one Peter?

I found this ad out west plastered on the wall of the men's room at the bookstore in Colorado's Monument Park. Don't worry, I didn't see any one in the stalls giving me a hand signal!

NOTE: This is not the only time that Rx ads have appeared in men's rooms. See, for example, "Proximity Marketing: From Urinals to Doctors' Offices, Track Your 'Target'"

According to the official Web site:

"Colorado National Monument is a little-known treasure full of surprises, and offers an interesting array of activities for visitors of all abilities and interests. Hiking, sightseeing and bicycling are just a few of the exciting choices awaiting visitors."

I wonder if any other blogger out there has come across other pharmaceutical ads that are not boring?

P.S. In case you didn't realize it, this is a joke. As far as I know, there is no such ad in the men's room at Monument Park or anywhere else.

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. You can access a recent iteration of Bob's OpEd online here.

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."

Of course, this drew my attention for two reasons: (1) I was one of those (unnamed by Bob) critics that suggested somebody be fired, and (2) the "thick-skin" quote suggested the subject of a post that I could write in response to Bob's piece.

Unfortunately, Bob's piece is not online yet, so I will quote it in its entirety here (dark-red quoted text) and insert my comments.
Bob said: "What used to be reserved for movies and books is now in vogue for DTC marketing tactics. I am speaking of reviewers. Whether you asked for it or not, there are numerous DTC ad critics out there who are anxious to give their opinion on the quality of your work. I am one of those reviewers. There are many others from other trade magazines and blogs who will gladly give their opinion on your latest commercial."
I have seen very few articles in trade magazines that had anything critical to say of specific DTC ads. I have written about this before (see "Trade Publications Must Be More than Drug Industry Cheerleaders!"), so I won't get into that again here.

There have been plenty of criticisms of DTC ads in blogs -- including this blog -- and on YouTube. Some of these criticisms have been scathing and, I imagine, require thick skins of the marketers whose ads are being criticized.

But let's not shed any crocodile tears over the plight of DTC marketers. I'm sure they get PAID WELL for what they do, whether or not their ads are successful! They can afford a truckload of skin softening creams to ease their pain! Or, they can just hug the awards they've received from trade publications.

Guideline #1: Do Not Evaluate DTC ROI
That's Bob's first principle:
Bob: "I am sure if we say good things about your work then numerous copies are made and passed up the line citing our analytical brilliance. On the other hand if we do not like what you produce, then we are likely misinformed about your objectives and strategies. I have some guidelines I use when I review your ads.

"First, I do not pretend to know whether it has a positive ROI. I do not do research on your ad and have no special data bank to use when evaluating it. So if I do not like it, I may be dead wrong from an ROI perspective.

"Second, I know most, if not all of you, quantitatively test your ads. Therefore you have an ad that is at least average for DTC or you would not have run it. So it is likely that your ad, no matter what critics say, is not going to be a disaster.

"Third, a much as we would like to make advertising a science, it is not. Critics may hate or love your ad for the wrong reasons. Some may want to see edgy copy; others may like a clear presentation of facts. The real measure is did it sell more product and help grow your brand value. Only you know that."
I, among many other journalists and bloggers, have famously criticized certain DTC ad campaigns for staying the course, despite obviously negative returns on investment ("In the first quarter of this year [2007]," reports the Chicago Tribune, "Takeda spent more than $40 million on Rozerem ads, TNS Media Intelligence figures show, and the company reported $26 million in sales during the same period." See "Rozerem Ad Spending Exceeds Sales!").

This must be a new principle for Bob because I know he likes to quote positive ROI data when defending DTC advertising in general. He must have meant to say, "I don't pretend to know if it [DTC ad campaign] has a NEGATIVE ROI."

In a June 20, 2003, OpEd piece entitled "Does DTC Deliver Strong ROI?", Bob said: "Perhaps the average ROI is $2.00 for every $1 invested. This is pretty good considering government bonds pay only $1.03 for every $1 invested."

In a more recent, August 11, 2006 piece entitled "Waste in DTC Advertising", Bob said: "Why is there a problem in setting objectives and measurement? It is largely because none of us really want to firmly set measurable objectives. We all like to believe that we are successful, and therefore, we like wiggle room in evaluating results. No agency will ever agree that they aired a bad commercial, yet we all can cite bad ads. No client wants to say that their DTC program failed, yet we know many have negative ROI. Human nature, therefore, is the biggest reason we have waste."

In other words, positive DTC ROI is good and pharmaceutical companies get better returns investing in DTC advertising than if they invested in Uncle Sam! Bob obviously knows that "many [DTC programs] have negative ROI." I am perplexed, therefore, why he will no longer consider ROI when commenting on DTC.

As I see it, DTC ads with negative ROI are another example of the waste in DTC advertising that Bob talked about.

Measuring DTC ROI and making sure it is POSITIVE is important not only from a business perspective, but also from a political perspective. Critics in Congress and elsewhere claim that DTC spending adds to the cost of drugs. That is one of the main arguments they have for limiting or banning DTC advertising. If the ads have negative ROI to boot, then that's money being wasted that has to be made up by keeping prices high or even increasing prices!

BTW, if you want to learn more about measuring DTC ROI, I invite you to listen to Dr. Andree Bates, a marketing ROI expert, who will be a guest on this Wednesday's
Pharma Marketing Talk Podcast

(listen live or the the audio archive here):

You Want Marketing ROI? You're Not Ready to Measure ROI!
If You Can't Define It, You Can't Measure It!
Airs LIVE, Wednesday, September 12, at 2 PM Eastern US time.
See more information here.


Some critics -- myself included -- want to see the industry do better (see "The Drug Industry Needs Constructive Criticism, Not Pugilistic Put Downs"). Attention to honest criticism is one way the industry can do better. If you are a critic of DTC advertising and you DO NOT take ROI into consideration, then you are not doing the industry any favors, IMHO.
Bob: "Some critics love to call you names, or say how incompetent you are. Some want you fired if they think your work is poor. I never do that because I know what it is like to try to create ads in the pharmaceutical environment. As I said, I trust that you always have more information than me and there must be a reason for your ad, even if I dislike it. That does not mean the critics are wrong, as more information is not always a guide to making great ads."
I admit it. I have called some people names and even suggested that they be fired. For example, I called Andy Hull, senior vice president of marketing at Takeda and the person responsible for the negative ROI of Rozerem DTC ads, a "maroon." Unless you are a fan of Looney Tunes, you might not even recognize that as an insult!

Listen. These people -- especially senior VPs -- get paid BIG bucks! I don't know how much but in the high 6 figures. (Peter Rost, infamous drug industry whistleblower and former Pfizer marketing VP had a salary of about $600,000 before he was fired!).

That money should provide Andy with as thick of a skin as he needs to protect himself against the puny barbs I throw at him.

Should he be fired? If he's not doing the job that he gets paid big bucks for, then, yes, he should be fired. Of course, only Takeda can make that assessment and decision.

Maybe Andy Hull should fire his current Rozerem ad agency -- as I also recommended -- and hire a new one. That just might save his job!
Bob: "In this new web environment where publishing criticisms is easy, it takes a thicker skin to be a good marketer. It also takes more courage to stretch the creative envelope because you know critics are ready to pounce. Some of those criticisms may get to your boss and cause you some grief trying to defend them. Unfortunately today's marketers just have to accept that main media, trade magazines and bloggers need to fill a lot of newly created web space. So if in the future I write about your ad, at least you can understand that it is never personal and I recognize the hard work that got you there. I do ask that you consider the possibility that some of the criticisms are valid and an open mind may help you improve your ROI."
Yes, some of the criticisms are "valid" and it's NOT just about "filling a lot of newly created web space" although I am not sure what Bob means by that. It's not as if I create Web space and then have to find something, anything to fill it.

My advice to DTC marketers: Don't let your head get too big about how "creative" you are. It 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.

Friday, September 07, 2007

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.

Dr. Bates has spoken at more than 45 international conferences in the past five years, and is currently working with pharmaceutical marketing programs in the ROI field at two universities. She has authored many articles in peer-reviewed journals and several chapters in books on this topic.

I am very pleased that Dr. Bates will be my guest on next week's 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!
Airs LIVE, Wednesday, September 12, at 2 PM Eastern US time.

Pharmaceutical marketers used to be mainly concerned with effectively delivering their messages, and ensuring the value of the individual programs. Now, pharmaceutical marketers are being asked to more thoroughly prove the effectiveness of their programs by quantifying exactly which messages impact prescribing the most, what the return on each sales and marketing program is, and what optimal combination of programs (and budgets) will deliver maximum prescribing (market share) results.

Unfortunately, many pharmaceutical marketers are more enamored by creativity than attaining a positive ROI (see, for example, "Rozerem Ad Spending Exceeds Sales!").

It's possible that these marketers can't handle the analytics -- aka math -- involved. Or they just don't know what to measure.

Well, Dr. Bates CAN handle the math and in this podcast she will tell you why your ROI analysis sucks! Specifically, she will address the following questions:
  1. What is ROI anyway?
  2. What are you measuring?
  3. Why is good ROI a paradox?
  4. So, you got a good ROI, now what?
  5. Forget R-O-I! What do you really want?
I know what YOU really want! You want this to be a video podcast, don't you? Then you can see Dr. Bates' charts and figures while the math zooms way over your head! Sorry, Charlie. This is an audio podcast, so you won't be distracted by any visuals. ;-)

Thursday, September 06, 2007

What's Up with the Veramyst "Brief Summary" Print Ad?

Veramyst is GSK's answer to Flonase going off patent.
"When Flonase went off patent, GlaxoSmithKline lost one of it's major money-makers," notes Pharmacy Mike, blogger over at Retail Pharmacy, Life, and General Lunacy. "Their response... Veramyst! Flonase is Fluticasone Propionate. Veramyst is the vastly improved fluticasone furoate."
You may have seen the new direct-to-consumer (DTC) ads for Veramyst on TV. I have. The one piece of information my wife and I took away from that ad was "may cause cataracts"!

Very Strange Print Ad
Maybe that's why GSK is running a very strange Veramyst print ad that is merely the "brief summary' -- which is neither brief, nor a summary -- aka, patient package insert (PPI). The image above shows the ad just as it appears in the September 10, 2007, issue of Time Magazine. It's prominently placed on a right-hand page within an editorial piece about John Edwards where you can't miss it!
Note: Pfizer ran a "Viva Viagra!" print ad within the same article. This is your typical drug print ad (see image below). On the reverse side of the Viagra ad is the brief summary, which is in large font and easy to read (not shown in the image below).

Usually, in print ads, the PPI appears on the back side of the display ad (see my analysis of print ads: "Print DTC: How Does It Measure Up?"). Nobody usually reads the PPI precisely because it's on the back of print ads and printed in dreadfully small font size -- just like the Veramyst PPI depicted above.

When I first saw the very strange Veramyst print ad in Newsweek, I thought the printer messed up and forgot to print the display portion of the ad -- you know, the nice big photo of a happy user of the product, big product shot, big benefit statement, some balance about side effects, like the Viva Viagra! ad.

But when I saw the ad again in Time Magazine, I knew it could NOT be a fluke.

Then, I thought perhaps the display ad was printed somewhere else in the magazine. But no! It is nowhere to be found!

I am only left with one conclusion: GSK purposely ran this "Brief Summary ad" for reasons that totally escape me.

If anyone knows the logic behind this, please let me and the readers of this blog know.

Wednesday, September 05, 2007

Novartis Attempts Perfect Execution of Web 2.0 Trick!

Novartis Vaccines and Diagnostics -- a division of Novartis Pharmaceuticals -- is attempting a perfect execution of the YouTube "User-Generated" Video Trick. This is just one of the Web 2.0 "tricks" the secrets of which I will reveal in my upcoming presentation on September 19 at THE Pharmaceutical Marketing Event in Philadelphia, PA (see "Web 2.0 Tricks for Pharma Marketers to Be Revealed September 19 in Philadelphia").
Hat Tip to NRx for bringing this to my attention (see "Novartis goes viral. Gets 710,000 views on YouTube.").
Lesson Learned From Michael Moore?
This is the second attempt to execute this "trick" amongst pharmaceutical companies that I know of (see "GSK's YouTube Disease Awareness Sponsorship").

Novartis is sponsoring a 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]." Novartis markets Fluvirin, a flu vaccine, which is aggressively being stockpiled the vaccine in the US in preparation for the upcoming flu season.

I wonder if Novartis took my advice when I suggested some time ago that pharma marketers and PR people -- such as the Gardasil promoters at Merck -- can learn a lot from Michael Moore regarding cause marketing via YouTube (see "Cause Marketing via YouTube: What Pharma Can Learn from Michael Moore").
Speaking of Merck and Gardasil, Ed Silverman at Pharmalot asked, somewhat in jest, "Imagine if Merck sponsored such a contest for Gardasil?" Ed, I already imagined that back in June! See the above link.
"To enter," says the Novartis sponsorship blurb, "create a short video that shows the seriousness of getting the flu, how it spreads, and why you should talk to your doctor about getting an influenza vaccination…The winning video will be seen by adoring fans across the globe and you’ll gain street cred as a bona fide contest winning filmmaker."

All the video entries must be uploaded to YouTube. Presumably, from there, the videos will spread as quickly around the virtual world as flu spreads around the real world!

Are Vaccines Funny?
"Make it funny. Make it dramatic. Make it your own," says Novartis. But whatever you do, DON'T "disparage" the Sponsor, according to the TERMS & CONDITIONS. This is the achille's heel in Novartis' plan. The contest may generate as many unofficial "disparaging" entries as legitimate entries! That, however, seems unlikely. Flu vaccines, after all, are not funny products. RLS and ED drugs, on the other hand, ARE funny products! By which I mean, easy to poke fun at.

What About Incorporating Winning Videos into DTC Ads?
It will be interesting to see how this contest plays out. The link to the "Official Rules" ( leads to an error message, so I cannot determine who will own the copyright, for example, to the winning entries.

It's possible, for example, that in exchange for accepting the $500 cash prize, winners will have to sign over copyright to Novartis. Then, Novartis could use the videos anyway it sees fit, including incorporating them into branded TV commercials for Fluvirin!

Now, that would be the ultimate flawless execution of the YouTube Consumer-Generated Video Trick!

Tuesday, September 04, 2007

Write a Review in Exchange for a Free Pass to an Industry Conference

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Viva Lovey-Dovey Viagra!

According to a University of Wisconsin-Madison physiology professor, Meyer Jackson, Viagra and other erectile dysfunction (ED) drugs "could be doing more than just affecting erectile dysfunction." Namely, Viagra increases the release of oxytocin, a key reproductive hormone (see press release here).

Sometimes called the "love hormone" or "cuddle chemical," oxytocin plays several important roles in social interactions and reproduction, including triggering uterine contractions and lactation. It is also released during orgasm and has been linked to sexual arousal.

No, this study was NOT funded by Pfizer, GSK, or Bayer, all of which market ED drugs. It was funded by NIH.

Jackson discovered this phenom in rats, measuring oxytocin released from rat pituitaries in response to neural stimulation. When the pituitaries were treated with sildenafil, they responded to the stimulation by releasing three times as much oxytocin as they did without the drug.
Sidebar: Sing the praises of these rats sacrificed for the betterment of man (and, by "man," I mean men, not women). To measure oxytocin release, researches must cut off the heads of the rats and mash their brains. A long time ago, I worked in a brain chemistry research lab guillotining many a rat. So I know how these things are done!
Furthering the Viva Viagra Cause!
"I hope that this doesn't cause some wild orgy of inappropriate recreational use," said Jackson.

Now why would you worry about that, Dr. Jackson? Perhaps because Pfizer's latest Viva Viagra DTC campaign (see "Viva Viagra Ad is No Cure for Morte Sales") has put the issue of recreational use on the front burner once again?
"Pfizer has been an outlier in shamelessly promoting Viagra as a party drug," said Michael Weinstein, the president of AIDS Healthcare Foundation. "All those Sin City references, everything associated with Vegas, that is what they want the association to be. It's not about a medical condition, it's about performance anxiety" (see "Pfizer Sings 'Viva Viagra' to Boost Sales of Its Drug").
Regarding limp ED sales, once the buzz about this study gets going, could we see an uptick in Viagra sales? If so, will Pfizer claim that its new DTC campaign is responsible?

Importantly, the drug had little if any effect on hormone release in the absence of stimulation. Interesting. What about self-stimulation while on Viagra or Cialis? Would that increase one's oxytocin levels and thereby increase one's affection for one-self? Inquiring minds want to know.

But any increase in lovey-dovey feelings induced by Viagra may be short-lived: "instead of (oxytocin levels) coming down in a minute or two, they stay up a little longer," said Jackson.

Maybe long enough for men to utter the words "I love you" after the act. Which may or may not be a good thing if chemically induced!