Pfizer May Own Your Penis, But Allergan, Maker of Botox & Kybella, Owns Your Face

Allergan is beginning an aggressive sales blitz for Kybella, the first injectable treatment for what the medical industry terms “submental fat.”

The first stage of the "blitz" is focused on dermatologists, the specialist physicians most likely to profit greatly from the use of Kybella by focusing on women.

If you do an image search on "Kybella" you'll find many images like the ones shown here currently being used by dermatologists in their online marketing (click on the collage for an enlarged view).

The images are undoubtedly supplied by Allergen to its physician clients. All are of about the same size and format.

“We own the face,” said Philippe Schaison, President US Medical at Allergan (click "Read more" below). Recall that Allergan also markets Botox using happy faces of woman (see, for example, "Botox BS Piled Higher and Deeper"). Imagine if the merger deal between Allergen and Pfizer went through! What would the Viagra ads have looked like?

A New Unmet Medical Need: Excess Adipose Tissue Syndrome

As reported by FierceBiotech (here), "Bayer Healthcare touted upbeat data from a pair of late-stage studies of an investigational drug [ATX-101, a synthetic version of a human bile component] targeting chin fat, setting the stage for the giant to step into growing aesthetic treatment market. And the results provide a victory from Kythera, which licensed the injected drug to Bayer for markets outside the U.S. and Canada".

“An injectable solution for reduction of submental fat is an unmet need in aesthetic medicine," said Patricia S. Walker, M.D., Ph.D., KYTHERA’s Chief Medical Officer.

"Based on evidence-based experience, ATX-101 represents a promising candidate for the reduction of submental fat," said Dr. Kemal Malik, Bayer's head of global development.

The "evidence" includes Patient-Reported Outcomes (PRO) that were evaluated on the basis of a 7-point "Subject Satisfaction Rating Scale (SSRS), a validated 5-point Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and a Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Calipers, an objective measure of submental fat thickness, also were used to assess the reduction of submental fat."

If this drug is approved in the U.S. I envision Bayer launching an innovative, "in your face," direct-to-consumer (DTC) advertising campaign. The first stage of the campaign will be focused on disease awareness.

First, you have to invent some new medical terminology. "Chin Fat" doesn't sound serious. Plus, you just don't say the "Fat" word in public. "Double Chin" is a common name given to this condition, but it also doesn't sound serious. Doctors need serious medical terms to use if they are going to prescribe drugs to treat what some people might not see as serious conditions.

More importantly, these names cannot be trademarked for marketing purposes. And marketers love medical conditions with memorable acronyms.

Therefore, let me suggest "Excess Adipose Tissue Syndrome" or EATS for the new medical condition/syndrome that Bayer can use in its disease awareness advertising campaign. Note that this terminology will also help foster "off-label" use of ATX-101 to treat other fatty areas of the body. While Bayer may eventually seek additional approved indications beyond chin fat, off-label use may be so popular that FDA approval for such uses will not be necessary.

The ads probably won't use images of EATS sufferers like the guy depicted above. First of all, Bayer is likely to begin by focusing on women. And not just older women, who don't have as much disposal income (I don't imagine that ATX-101 will be covered by Medicare).

A hint of the image that Bayer might opt for is shown in the screen shot below, which was taken from a site that is recruiting subjects for "The Double Chin Research Study" clinical trial in the U.S.

(click on the image for a larger view)

Here you have a "typical" EATS sufferer: a young, affluent, woman who probably also uses BOTOX to smooth her frown lines. She can go to her cosmetic physician and get TWO shots: one for Botox and one for ATX-101, which is delivered via injection.

When it comes time to do branded DTC advertising, Bayer might opt to follow Allergan's BOTOX DTC strategy: i.e., stick to "reminder ads" -- A reminder ad mentions the pharmaceutical brand name but not the indication or medical condition it treats. Such ads do not need to mention any side effects, not even the dangerous side effects, if any.

But wait! Bayer HealthCare is a signatory to PhRMA's Guiding Principles for Direct-to-Consumer (DTC) advertising, which prohibits reminder ads. PhRMA's principles, however, apply only to TV and magazine (print) ads. So Bayer can use the technique on the Internet, YouTube, via social media, or in outdoor ads such as this Levita (marketed by Bayer) Reminder Ad Sighting.

Reminder Ads OK in EU But Not in US. Huh?

The Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expanded its practice code to cover all interactions with health-care professionals, medical institutions and patient organizations, including a ban on doctors from receiving payments to attend conferences (see "Big Bad Pharma, Bribery and the New EU Industry Code").

According to the above cited source (WSJ's "Corruption Currents" blog) this was a bit like closing the barn door after the cows have left:

"This comes at a time when the association’s members are trying to drum up business in developing countries, some of which have state-run health systems. Employees of such systems, including doctors and nurses, can be considered foreign officials under the U.S. Foreign Corrupt Practices Act, a 1977 law that bars bribing foreign officials for business purposes.

"To that end, the Securities and Exchange Commission and the Justice Department are in the midst of a sweep of the industry. In April 2011, Johnson & Johnson agreed to pay $70 million to resolve violations, and The Wall Street Journal reported in November 2011 that Pfizer Inc. will pay more than $60 million when its settlement gets finalized.

"Both companies, the Journal reported, ratted on their competitors.

"Those competitors included AstraZeneca, Merck & Co., Bristol-Myers Squibb Co., GlaxoSmithKline PLC and others that have disclosed investigations for possible FCPA breaches. Eli Lilly & Co. was in advanced talks in April 2011 with the Justice Department, and the company said Feb. 24 in its annual results it’s at the same level with the SEC.

"Letters of inquiry to several of the companies, dating back more than a year, laid out several types of of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals."

Any way, I decided to download the new "IFPMA Code of Practice" to see if there was anything interesting or actually new (you can find it attached to the post here). The code is intended to cover "interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products."

This section popped out at me:

5.2 Reminder Advertisements

A “reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For “reminder” advertisements, “abbreviated prescribing information” referred to in Article 5.1 above may be omitted. 

The "abbreviated prescribing information" include "an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications, precautions, and side-effects."

In other words, it is perfectly OK to promote drugs to healthcare professionals and patient organizations using reminder ads that do not include safety information. Note: these ads must be print ads in professional publications because no such ads would be allowed on mass media such as TV, which reaches consumer audiences. Promotions  of Rx drugs to consumers is not allowed in the EU, reminder ads included.

The U.S. pharma industry does not have a "practice code" for advertising or "marketing" to healthcare professionals, medical institutions and patient organizations. It does, however, have "Guiding Principles" for direct-to-consumer (DTC) advertising, published by PhRMA (the U.S. industry trade association) in December, 2008. Principle 13 states "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." I.e., NO REMINDER ADS!

Of course, PhRMA's principles leave open the door for running DTC PRINT ads, although I haven't seen many of these in the consumer publications I read. The exception is BOTOX, marketed by Allergan, which has NOT signed on to PhRMA's principles (see "PhRMA Intern vs. BOTOX!").

So, why does the IFPMA Code of Practice specifically carve out an allowance for "reminder ads?" Is that a technique often used in the EU to win over the hearts and minds of healthcare professionals? I don't get it.

Allergan "Badly Let Down" by Employee Tweet

The Prescription Medicines Code of Practice Authority (PMCPA) ruled that Allergan breached UK pharma's self-regulatory Code of Practice because an employee accidentally tweeted publicly about Botox (read the details here "Brits Versus Botox Tweet").

Basically, an employee sent a public tweet to a friend in which he/she mentioned Botox and said "... we could do something around stroke rehab..." That was considered advertising to the public, a no-no in the UK and the rest of the world outside the U.S.

But PMCPA showed compassion saying that it noted that Allergan had a policy that clearly stated "no Allergan employee might comment in a social media forum about Allergan products or business activity."

PMCA added "The Panel considered that Allergan had been badly let down by its employee."

I sure would like to see Allergan's "Global Social Media Policy." I wonder if it is similar to Pfizer's infamous "social media playbook?" (see here).

Maybe Elya Zarra, who is currently part of Legal Department - Regulatory Affairs/Compliance at Allergan would send me a copy. Part of her duties include "Development and implementation of internal policies and strategies, including a global social media policy" (see her LinkedIn profile). I can't send her a direct message through LinkedIn because she requires contact only through her LinkedIn friends. And she doesn't have a Twitter account that I can find. Perhaps it's against policy for her to have one.

"Reasonable" $600 MILLION Fine for Misbranding BOTOX: I Guess Allergan's Suit Against FDA Paid Off!

Allergan -- the company that markets Botox legally for wrinkles and illegally for other things -- agreed to pay $600 million in fines, including $375 million to the government as part of a Botox “misbranding” charge. Allergan admitted that its marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy. Read the media stories and press releases here.

Considering that Eli Lilly paid $1.41 billion to settle charges that it had improperly marketed  Zyprexa for elderly patients with dementia and that Pfizer paid $2.3 billion to settle charges that it had illegally marketed the painkiller Bextra, the $600 million Allergan has to pay seems "reasonable," which is exactly how  Larry Biegelsen, an analyst at Wells Fargo Securities in New York, described it: “The $600 million settlement amount appears reasonable based on industry standards.”

Why such a "reasonable" settlement for a drug company that, IMHO, is an unethical marketer and the the drug industry poster boy for off-label promotion? Allergan, for example, has refused to abide by PhRMA's DTC Guidelines as well as PhRMA's Guidelines for Interactions with Healthcare Professionals (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway"). Allergan has also been cited by the FDA for other violations such as a misleading Latisse Web site (see "FDA Reads My Blog: Declares Latisse Web Site Misleading").

You must read a bit further down in the media articles about this to learn that Allergan "is required as part of the agreement to drop the lawsuit it filed against the FDA in October challenging a government rule that prohibits marketing drugs for unapproved uses."

There's a lot to ponder when reading that statement.

I ponder, for example, whether Allergan got off much easier because it agreed to drop its suit? Which was probably frivolous to begin with!

BTW, I've written about Allergan's off-label migraine shenanigans previously. See Allergan's "Eye-popping" Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

Allergan is currently seeking FDA approval of Botox for the treatment of migraine. In the above post I reviewed a clinical study that Allergan is doing to support its case. The drug was so ineffectual that the researchers admitted they “have searched for patient characteristics that may predict a favorable treatment response.” Of course, they ultimately were successful in winnowing down the migraine population that is responsive to treatment: ie, those people who suffer from "imploding" or "eye-popping" headaches but NOT "exploding" headaches.

This would all be a joke if Botox was not such a dangerous drug, which includes a black box warning on its label. But I won't get into that -- you can read what other people have to say about the dangers of Botox here.

P.S. As part of the agreement with the Justice Department, Allergan also will be required to publish information about its payments to doctors. I am not anticipating that Allergan's physician payment information will be easy to analyze considering that much more ethical drug companies have failed to be transparent in this regard (see "Transparency Vs. Translucency in Reporting Physician Payments").

Allergan's "Eye-popping" Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

"A preliminary study suggests the same type of botulinum injection used for cosmetic purposes -- Botox -- may be associated with reduced frequency of migraine headaches that are described as crushing, vicelike or eye-popping (ocular), but not pain that is experienced as a buildup of pressure inside the head, according to a report in the February issue of Archives of Dermatology, one of the JAMA/Archives journals" (see press release here).

This caught my attention because (1) this study was supported in part by a grant from Allergan Inc., the company that markets Botox, (2) co-author Dr. Burstein serves as a consultant to Allergan Inc. and receives honoraria for lectures and grants for clinical and animal research, and (3) the authors admit how difficult it is to demonstrate that Botox is more effective than placebo for treatment of migraine headaches.

Regarding the latter point, the authors write: “The initial promise of a new prophylactic [preventive] therapy for migraines was met by the challenge of replication of these results,” as subsequent studies have failed to demonstrate botulinum was more effective than placebo.

Sounds like the end of the road for Botox as a treatment for migraine. But wait! The authors acknowledge that “researchers have searched for patient characteristics that may predict a favorable treatment response.” In other words, let's find some migraine patients for whom Botox works.

According to this study, Botox may be effective in the treatment of "imploding" or "eye-popping" headaches but NOT "exploding" headaches. Among all participants who responded to treatment, patients with exploding headaches experienced an average reduction in migraine frequency of 11.4 to 9.4 days per month (ie, not much improvement), whereas frequency in participants with imploding or ocular headaches reduced from an average of 7.1 days per month to 0.6 days per month.

“These preliminary data are intriguing, and our results provide support for the hypothesis that patients with migraine that is characterized by imploding and ocular headaches are more responsive to botulinum toxin type A than those with migraine characterized by exploding headaches,” the authors write. “Our findings invite consideration of using botulinum toxin type A injections to prevent migraine headaches and may promote the role of the dermatologist in the treatment of patients with migraine. However, well-controlled trials need to be conducted to confirm these findings.”

The article estimates that 28 million Americans suffer from migraine headaches. It does not specify how many suffer "imploding" vs "exploding" headaches. It does say that 10 of the 18 patients studied experienced the former type. From that, one might assume that 15-16 million Americans suffering from migraines could be helped by Botox -- AND smooth out those wrinkles at the same time!

I am sure that Allergan will be packaging reprints of this study to hand out to physicians even though Botox is not approved for the treatment of migraines. The Allergan reps may even use my faulty analysis to claim that there are 15-16 million potential migraine patients out there that dermatologists can tap into.

New FDA guidelines permit this kind of off-label promotion -- I mean "freedom of speech," also known as "freedom of expression" in Botox ads like the one on the left, which I modified to show how it might look after FDA approves Botox for "eye-popping" migraine relief.

Allergan is the the drug industry poster boy for off-label promotion; it is currently suing the FDA "seeking a ruling that would allow [it] to proactively share truthful and relevant information with the medical community to assist physicians in evaluating the risks and benefits of BOTOX" (see press release).

Hallelujah! The Recession is Over! Sales of "Lifestyle" Drugs Like Botox & Cialis On the Rebound.

As reported over at minyanville.com ("Sign of the Times? Cosmetic Surgery Is Back"):

According to a survey done by MEDACorp, plastic surgery and cosmetic procedures were up during the fourth quarter [of 2009] for the first time since the downturn began in 2007.

The survey encompassed facial injectibles, breast implants, laser procedures, and Latisse for eyelash growth. The results of the survey indicated that procedures for botulinum toxins like Allergan’s (AGN) Botox and facial fillers like Medicis Pharmaceutical’s (MRX) Restylane increased the most year-over-year in the fourth quarter of 2009, each up 8.1%. Procedures for breast implants increased 3.5% and laser work was up 1.6%.

Cialis is also having a good year, reported the IndyStar (see "Lilly's Cialis meets with success, challenges"):

"Lilly has been able to double the price of the drug since its launch in 2003, to about $16 a pill. Last year alone, during a recession, Lilly increased the price of Cialis twice. Competitors, including Pfizer (maker of Viagra) and GlaxoSmithKline (maker of Levitra), also raised prices."

It seems that you can never have too few wrinkles or be too erect even if it means sacrificing the necessities of life like a new Lexus (Toyota) or season football tickets.

New Regulatory Wrinkle: Cosmetic Doctor Gets FDA Warning Letter! Who Snitched?

In what has been called a "first," the FDA "has cracked down on one of the most widely quoted cosmetic doctors, sending shudders through the ranks of opinion leaders in fashion publishing and vanity medicine," according to the New York Times (see here).

"The F.D.A. recently sent a warning letter to Dr. Leslie Baumann, a well-known dermatologist and clinical researcher in Miami Beach, citing the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved," said the New York Times.

FDA, in its letter, cited statements made by Dr. Baumann in newspapers and television that "clearly suggested that Dysport was safe and effective before it was approved, and that it was in fact superior to the approved product Botox because it lasts longer and starts working faster than Botox."

Baumann was hired as a Phase III clinical investigator by Medicis Pharmaceutical, which hopes to market Dysport in the United States. FDA says that Baumann "became involved as an investigator in the research trials for Dysport in July 2006" and she made the statements while she was involved as an investigator for Dysport.

According to FDA’s regulations at 21 CFR 312.7(a), “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug” (emphasis added).

The FDA begins its letter: "As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has become aware..." of the promotional comments made by Baumann.

Now, how do you suppose the FDA "became aware" of these comments? Could it have been a "personal communication" from Allergan, the marketer of Botox, which was dissed by Baumann? "Reloxin, the new Botox, will likely come out later this year," said Baumann. "Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market—the Botox people (Allergan) raised their price another 8 percent this year!"

The FDA said "we are not aware of any adequate and well-controlled head-to-head trials that compare Dysport to Botox to determine whether Dysport lasts longer or starts working faster than Botox."

I don't suppose Allergan liked that Baumann dissed their product and I'm willing to bet they snitched on Baumann to the FDA.

Let the era of pharma-on-pharma snitching commence! Maybe there will be a "STOP Snitching" movement in the pharmahood!

Botox: Pharma's Answer to Duct Tape

“We see it as a molecule that keeps on giving. As we understand it more, it gives us new ideas of how to use it,” says Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker (see NYT: "So Botox Isn’t Just Skin Deep").

"In the hunt to discover the next blockbuster medical use for Botox, doctors have injected it experimentally into muscles and glands all over the body, making it medicine’s answer to duct tape," says the New York Times. "According to recent medical journals, physicians have used it to treat chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures and pain from missing limbs."

Of course, these are all off-label uses of Botox, meaning that the FDA has not approved the marketing of Botox for these purposes.

But now, with the poor economy, and sales of Botox for approved cosmetic uses down, off-label uses of Botox "are poised to outstrip the cosmetic treatment in both revenue and prominence."

No wonder that Allergan has not signed on to PhRMA's DTC advertising guidelines and continues to run "reminder ads" (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway").

BTW, it isn't likely that Allergan will EVER want to get official FDA approval for ANY of the above-mentioned uses of Botox. Can you imagine what the reminder DTC ads might look like for "drooling" and "anal fissures?" Wait..hair loss. That one MAY be possible!

Botox v. Reloxin: Market Share Battle May Revive DTC Spending Late in 2009

If you thought the DTC advertising sleep aid (Lunesta v. AmbienCR v. Rozerem) advertising war was excessive, wait until Reloxin is approved for marketing by the FDA, which may happen during the second half of this year according to Bloomberg.com (see "Medicis's Reloxin May Vie With Botox in U.S. to Clear Wrinkles").

“The results of the study [published in the March/April issue of Archives of Facial Plastic Surgery] show that it’s as good as Botox," Ronald Moy, the lead author of the study and a professor in the medical school at the University of California, Los Angeles, in a March 13 telephone interview. "The side effects are the same as Botox."

So...how's Medicis going to capture 25 percent to 30 percent of market share from Botox as one analyst claims it will? And how will Allergan, which markets Botox respond?

Advertising of course!

"It's important that people just recognize that these are different products," said a spokeswoman for Allergan.

And to make people "recognize" the difference you'll need lots and lots of advertising! And I don't mean the reminder DTC ad crap that Allergan has been getting away with for years (see "Botox BS Piled Higher and Deeper" and "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway").

But there's going to be those nasty side effects to deal with and include in any "above-the-board" DTC ad. "The researchers found that 804 of the 2,838 adverse events reported by patients were probably or possibly related to the treatment."

According to Moy "Many of our patients liked it [Reloxin] even better." Maybe Medicis can stick with reminder ads and use "You'll like it even better!™" as a tag line? I think I'll trademark that!

P.S. As pointed out in a comment to this post, Johnson & Johnson has agreed to acquire breast-implant maker Mentor for $1.07 billion. The deal could also give Allergan a big rival in the wrinkle-fighting space, as Mentor awaits FDA approval for a Botox competitor. So there could be THREE anti-wrinkle meds out there soon vying for market share!

Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway

Allergan, the specialty pharma company BEST known for its marketing of BOTOX, was voted the "Most Admired Specialty Company" in the Eighth Annual Med Ad News Most Admired Companies contest/poll/popularity contest.

Allergan achieved this distinction among Med Ad News readers who were polled by the publication despite the fact that the company does not abide by PhRMA's DTC Guidelines that prohibit "reminder ads." Reminder ads mention the pharmaceutical brand name but not the indication or medical condition it treats (see definition here).

ALL BOTOX direct-to-consumer print and TV ads are reminder ads, which are free to imply outlandish benefits -- such as "freedom of expression" (see "Botox BS Piled Higher and Deeper") -- without any counterbalancing risk information as required by FDA regulations simply because FDA is not empowered or inclined to regulate reminder ads.

Most of the rest of the drug industry have ceased to run reminder ads.

I also notice that Allergan is not a signatory to PhRMA's new Guidelines for Interactions with Healthcare Professionals (see PMN Reprint #77-01). Allergan sales reps, therefore, are likely flooding dermatologists' offices with logoed pens, pads, and other "tchotckes."

All this while Solstice Neurosciences, the company that markets Myobloc, a BOTOX competitor, is playing by PhRMA rules.

But I'm not only complaining that Allergan is admired for its audacity to side-step industry best practices. What startled me when reading the glowing 2-and-one-half page spread dedicated to Allergan in the October 2008 issue of Med Ad News was that BOTOX was mentioned only briefly, in a short paragraph, and not in bold text as were other products that were discussed at length. There was no mention of any problems with FDA (see below) and no sales trend data for Botox. Every other product Allergan EVER made and marketed or has in the pipeline WAS mentioned in great detail! Keep in mind that BOTOX accounts for about one-third of Allergan's 2007 $3.9 billion in sales and Allergan is currently seeking approval for a new BOTOX indication (migraine).

"Joe the Investor" is Misled
BOTOX sales performance has recently taken a "hit" due to FDA investigations and competition.

In February 2008, the FDA issued an "Early Communication" about BOTOX safety issues and began investigating reported deaths attributed to BOTOX use (see "Early Communication about an Ongoing Safety Review Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)"). That hurt sales and Allergan's stock performance.

Obviously, this story did NOT get included in Med Ad News' glowing account of Allergan. Instead, the story focused on Allergan's 2007 sales and stock performance. I suspect, in fact, that the Med Ad News article was written by Allergan itself -- there's no byline indicating the author as in other articles in the publication.

Considering the dismal performance of Allergan's stock over the past year, the Med Ad News article does a disservice to "Joe the investor" by presenting a biased view of a company with low marketing standards. If it was written by Allergan, shouldn't the SEC required disclaimer be included?

Tomorrow, I hope, Chris Truelove will provide the Med Ad News side of the story in her Pharma Blog Review blog.

---

UPDATE: Christine Truelove responds...

"John Mack at the Pharma Marketing Blog had some complaints about Med Ad News‘ writeup of Allergan as Most Admired Specialty Company. Well, Mr. Mack, here’s the explanation. Med Ad News didn’t pick Allergan as Most Admired Specialty Company — our readers did, in online polling. But Allergan didn’t supply the writeup; Managing Editor Andrew Humphreys did, from examining Allergan’s own press releases and reports. Since the readers picked Allergan as the most admired among the top 25 specialty drug companies by revenue, he had to write about why they might have done so. Yes, we know about the falling sales of Botox and FDA investigations; I believe our readers do as well. Yet, they still picked Allergan, which meant we had to focus on the things that may have spurred their decision. As Mr. Humphreys put it to me, “My job is not to point out the problems for the companies that are voted as winners, because all companies have issues in one way or another. This story was about what makes them admirable. We have other forums to discuss issues such as drug advertising regulation.” By the way, I doubt “Joe the Investor” is reading us; our circulation is to the pharma and marketing industries and some academics. But your criticisms are being taken constructively; they’ve given me some ideas as to change the format of these writeups for next year.

Stay tuned ..."

Thanks for your response, Chris. I'm happy that you are taking this as constructive criticism regarding future writeups of your survey winners -- and, yes, I know Med Ad News readers voted on this and not the editors, a fact that I specifically mentioned in the second paragraph of my post.

I am surprised, however, that you don't consider "Joe the Investor" as a reader. Many people working in the pharma and marketing industries -- your core readers as you say -- also invest in the drug industry. Drug company "Joe" and "Jane" employees get stock options or buy their company's stock as part of their 401K plans. Many people may also diversify their holdings by buying stock in drug companies other than their own. Then there are all the Med Ad News readers that work for companies that service the pharmaceutical industry. I am sure many of them are also interested in investing in the industry.

Maybe Allergan's employees willingly drink the Allergan corporate Koolaid that appears in the press releases that your editor copies, but other pharma and service industry employee/investor readers of your magazine deserve a more balanced view.

Botox BS Piled Higher and Deeper

Have you seen the latest ads for Botox? The tag line is "freedom of expression..." The ads go on to say "Don't hold back! Express it all!" The copy writers certainly don't hold back on the exclamation points!!

The not-so-subtle subliminal message is "despite what has been reported in the press and on blogs by patients (see "Botox Banality Not a Boon for TV Sitcoms"), use of Botox does not limit your range of facial expressions." To prove the point, ads like the one shown here feature a woman in several different poses, presumably showing a range of impressions.

Pretty impressive evidence, wouldn't you say?

I have tried to fathom the thoughts of the woman in the ad and put these in thought balloons superimposed on the ad (see image). I think I captured the essence of these expressions. Don't you agree? BTW, feel free to suggest your own thought balloons in comments to this post and I will create new graphics that incorporate the best.

Carefully Wrought Bullshit
These new Botox ads, aside from being reminder ads that are frowned upon by responsible pharmaceutical marketers, are examples of "carefully wrought bullshit," in the words of Harry G. Frankfurt, author of the tongue-in-cheek book entitled "On Bullshit."

According to Frankfurt, "the realms of advertising and of public relations, and the nowadays closely related realm of politics, are replete with instances of bullshit so unmitigated that they can serve among the most indisputable and classic paradigms of the concept."

I have devised a Pharma Marketing BS Meter^TM, which rates the BS level of DTC ads. On the left is the BS Meter for these Botox ads.

What's your rating of the BS level of these ads? Take my little survey and let me know. P.S. Don't forget to submit your thought balloons in the comments section. Thanks!

Compared to other DTC ads, what's the level of BS in Botox ads?
	Very High
	Somewhat High
	Average
	Somewhat Low
	Very Low

Botox Banality Not a Boon for TV Sitcoms

Despite extolling the ability to "express yourself" while under the influence of Botox in recent TV "reminder ads" -- which, BTW, go against the self-imposed industry ban on such ads -- TV studios are finding it increasingly difficult to find women actors who can express themselves, according to Wall Street Journal article ("The Backlash to Botox").

Left, Janice Dickinson (Botox Banal) in scenes from her reality show, 'The Janice Dickinson Modeling Agency'; right, Julia Louis-Dreyfus (Botox Free) in 'The New Adventures of Old Christine.'

"The rarest commodity in TV these days, say veteran casting directors: stars without Restylane-frozen faces and collagen-inflated lips."

Botox Not Comical
"Successful sitcoms," notes the WSJ, "including 'Old Christine,' typically feature actors and actresses who use a heavy arsenal of facial expressions. Failed comedies -- for example, 'Hope & Faith,' 'Listen Up' and '20 Good Years' -- often feature performers that border on cardboard caricatures. 'Frozen isn't funny,' says [Joel Thurm, who served as Aaron Spelling's casting director]."

Also not comical are some of Botox's possible side effects and adverse events, including respiratory arrest, paralysis of swallowing muscles serious enough to require the insertion of a feeding tube, arrhythmia and myocardial infarction. Some cardiovascular events associated with Botox were "fatal" according to the BOTOX package insert.

Of course, none of these have to be mentioned in the "Express Yourself" Botox ads because FDA does not require it in reminder ads, which do not mention what the product is approved to treat. Obviously, Allergan, who makes and markets Botox, would prefer NOT to mention these bad things, hence it continues to run reminder ads despite the drug industry's self-imposed ban on such ads (see "Allergan Ignores Guidelines, Wins Award Anyway" and "PhRMA Intern vs. BOTOX!").

You also won't easily find these possible side effects and adverse reactions on the Botox web site, which merely states "Do not use BOTOX Cosmetic if you:

* have an infection where BOTOX Cosmetic will be injected
* are allergic to any of the ingredients in BOTOX Cosmetic
* are pregnant or think you might be pregnant."

It then states "Ask your doctor or pharmacist for the Professional Package Insert for complete information." And if you scroll way down to the bottom of the screen, you can click on "Prescribing information" and read the package insert. If you make it to page 2, you will find the nasty stuff.

The "Express Yourself" reminder ads are an obvious reaction to the well-documented lack of expression often associated with Botox. This "side effect" of Botox, which is not listed in the package insert as a side effect, is driving US TV studios to hire British actresses who are not so medicated. According to the WSJ, this contributes to the "increasing globalization of television casting."