Thursday, October 30, 2008

Alice, 35, is Not a Real Ambien CR Patient.

You've GOT to check out the new Ambien CR web site to witness what has to be a new low for "authentic" pharmaceutical marketing: patient testimonials from people who are "not actual patients" and not real people at all!

Take Alice, for example. That's her on the left in the above image, which is a collage of two iterations of an animation of a rotating Ambien CR pill with what appear to be real Ambien CR users telling us why they are "sticking" with Ambien CR. Brian, shown on the right, was "tired of over-the-counter sleep aids leaving me groggy the next day." Alice, on the left, says she "wasn't treating my sleeping problem."

You can click on Alice and get more information, including a detailed testimonial as shown in the screen image below:

Click on the image to enlarge it and see what Alice has to say.

Obviously, actors are used in direct-to-consumer (DTC) Rx drug ads all the time. Sometimes, we are lead to believe that actors playing doctors in TV ads are real doctors or actually rowing when they are not (see "Jarvik: A Modern DTC Tragedy"). On TV we also see actors portraying patients. Sometimes they even speak and say how the drug helped them. Most often, however, these "patients" don't really say anything. They certainly are not identified by name and age as are the Ambien CR "patients" depicted above.

This new online Ambien CR promotion was no doubt developed in response to a print ad by Lunesta, which compared a wide-awake woman who took Ambien to a pleasantly-asleep woman who took Lunesta:

The Lunesta ad is a bit unfair in that it is "comparing apples to oranges." The more relevant comparison would be between Lunesta and Ambien CR, which, like Lunesta, is approved to help people stay asleep all night.

Consumers may not realize the difference between Ambien and Ambien CR when presented in this context, hence the new Ambien CR promotion, which tries to highlight the difference even if it has to rob Peter to pay Paul (ie, take shots Ambien -- one of those "over-the-counter" sleep aids that may be leaving Brian groggy).

[Note: Mark Tosh, Editor-in-Chief of DTC Perspectives, commenting on this ad in DTC Insights said "This new approach from Lunesta seems to be moving in a direction that could draw more scrutiny from critics and regulators who want to impose limitations on DTC."]

Although there is a disclaimer stating that the person depicted on the Ambien CR screen is "not a real patient," the Ambien CR promotion on the Web site resembles a social networking post made by a real person claiming to be an Ambien CR user. It appears to me that Sanofi is trying to capitalize on the fact that testimonials by real -- or seemingly real -- people are one of the most important kinds of information that consumers rely upon to make decisions. The only problem is, however, it could not get these testimonials from real people or it didn't feel it had to spend the money to do that. It's just another example of how pharmaceutical companies do not wish to engage with their customers for fear that they may hear more about adverse events than about product benefits.

Personally, I don't think it's acceptable to put quotes around the product promotion to make it look like this is something a real person, other than a real marketing person, has said. The disclaimer says "not a real patient." What it should say is "Alice" is "not a real person and did not actually say what is written on the screen and enclosed in quotes."

P.S. How did they get all those people to stand on a tiny pill? Wendy Blackburn over at ePharma Rx Blog has the answer.

Tuesday, October 28, 2008

Allergan's Secret Plan to Thwart Homeland Security and the FDA Approval Process

I read with interest Jim Edwards' recent story about how "Allergan’s Eyelash Enhancer Makes Your Blue Eyes Brown."

It appears that Allergan's strategy for expanding the market for Lumigan -- its anti-glacoma drug -- is to capitalize on one of the drug's side effects: patients’ eyelashes become longer when using it!

Of course, many women love long eyelashes and spend a lot of money on cosmetics and even permanent tattooing to make their lashes longer or seem longer. In fact, according to Edwards, doctors are already using Lumigan eye drops off-label for vanity purposes (more on that below).

But there's another side effect of Lumigan that may make it useful to terrorists and other criminals who seek to fool security systems that depend on iris recognition technology -- Lumigan can change the color of your eyes (eg, make blue eyes brown). Of course, this side effect would only be useful for blue-eyed terrorists and, as we all know, most terrorists throughout history -- excepting Nazis, of course -- have been dark-eyed.

Jim noted this problem and mentioned that one of his "cosmetic dermatologist sources said upon learning of the effect, 'I must tell my mafia clients!'"

Mafia. How quaint! Does the FBI still go after the "mafia"? And, let's not forget that most mafia types are of the dark-eyed genotype.

In any case, if you are like thousands of Med Ad News readers who think that Allergan is a pharma company to be admired (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway"), then you probably admire Allergan for its creativity in attempting to turn a sow's ear of a drug into a silk purse! ["Lipstick on a pig" may be the more appropriate, but less politically-correct, metaphor!]

Not that there's anything wrong with that -- many drug companies have benefited from exploiting side effects of drugs meant for other purposes (eg, Pfizer and Viagra) -- but Allergan often does not play by the rules as I pointed out in the blog post I cited in the previous paragraph.

I suspect, however, that Allergan's strategy is NOT to seek FDA approval of Lumigan for eyelash enhancement. For one thing, it is too ridiculus to waste FDA's precious time reviewing such a trivial indication for a drug. But the main reason I say this is because Allergan has a history of relying on off-label use and avoiding marketing rules.

For example, Edwards reminds us that Allergan is under investigation by the Department of Justice for alleged off-label promotion of Botox for headache (see "The Allergan-Medicis Vanity Pharma Death Match Is About to Get Complicated").

And, for what it's worth -- and according to several reader comments it's not worth much -- neither Allergan nor Medicis is a signatory of PhRMA's new guidelines for interactions with healthcare professionals. Both companies are free to wine and dine dermatologists and convince them to use their products off-label.

The clincher, however, comes from Allergan itself. If you look for any clinical trials for the use of Lumigan for eyelash enhancement on the Allergan site, you'll find bupkis, nada, zilch. On Allergan's Medical Aesthetics ongoing clinical trial web page you'll find "No studies currently recruiting at this time."

No trials are necessary either for certain dermatologists who are pretty upfront about using Lumigan off-label. Here's the pitch one dermatologist makes on her Web site: "Achieve Luxurious Lashes with Lumigan®. Only available through physicians this miracle solution stimulates your own eyelashes to grow longer and thicker. Easy to use at home with only a once daily application." The following photos are offered as evidence of Lumigan's effectiveness in enhancing lashes:

P.S. The dermatologist mentioned above is Lorrie Klein, M.D., who claims to be one of the "Top 10 Botox & Juvederm Injectors in United States!"

OMG! She must get lots of perks from Allergan AND Medicis! No doubt she's shooting to achieve Top 10 status among "Lumigan Droppers" too!

Monday, October 27, 2008

Chantix + Viagra = ChanGra-La for Pfizer?

A time-honored strategy pharmaceutical companies use to keep brands alive after patent expiry is to combine one brand with another to create a combination pill. Pfizer, for example, has combined Lipitor and Norvasc to create Caduet.

I suggest that Pfizer start thinking about its Viagra erectile dysfunction (ED) franchise. Viagra will go off patent as early as 2011.

One specific suggestion I have is to combine Viagra with Chantix (indicated for smoking cessation). I call this combination "ChanGra-La," which is pronounced virtually the same as Shangri-La, the mystical, harmonious, earthly paradise and utopia described in the novel Lost Horizon.

"What," you may ask, "could justify such a combination?"

Glad you asked!

According to an Italian study mentioned in a BMJ news item ("Erectile dysfunction may be an early sign of heart disease, suggests new research"), of 860 middle aged men, 40% of men who had erectile dysfunction (ED) smoked heavily, compared with 4% in the control group. Another study provided a link between ED and heart disease: "A pilot study by Greek researchers evaluated the incidence of asymptomatic coronary artery disease in 26 men with erectile dysfunction and found that nearly a quarter (23%) had coronary artery disease confirmed by angiography," reported BMJ.

In other words, if a pill like ChanGra-La can simultaneously help middle-aged men quit smoking AND obtain an erection, that therapy would have an extra-added benefit of preventing future heart attacks. A virtual "Shangri-La" for Pfizer!

There would be added benefits as well. Chantix, for example, has some notable "side effects," such as vivid "dreams" or hallucinations that may heighten a man's sexual experience. In fact, many dreams associated with Chantix are sexual in nature (see "Chantix Californication Dreamin': Viagra II"). This should not surprise anyone who knows that Chantix works by competing with nicotine to stimulate the brain's pleasure center.

One problem I foresee is that both Viagra and Chantix are not approved to be taken in daily doses or for a long period of time. Pfizer, however, should easily be able to find a work-around. After all, there is now a daily dosage form for Cialis, which competes with Viagra.

The Chantix portion of ChanGra-La is a bigger problem. It is recommended that Chantix be taken for only 12 weeks, whereas ChanGra-La would have to be taken indefinitely to be effective. I'm not sure how to get around this -- maybe have an alternating 12-week cycle of ChanGra-La with Chantix followed by a cycle of Chantix replaced by a placebo compound (eg, sugar), etc.

Obviously, such a regimen would require not just a pill, but also a support "program." Pfizer already has some related experience from its Chantix "GETQUIT Support Program." For ChanGra-La, I suggest a "GETHARD Support Program."

"But hasn't Pfizer recently announced it would no longer invest in cardiovascular drug research?," you might ask.

Yes it has. But the beauty of the ChanGra-La strategy is that it requires virtually no R&D, just a little trial at worst.

Approval by FDA should be a cinch. There's probably no middle-aged man out there who would not like to take ChanGra-La and since most FDA advisory committee members and reviewers are closed!

Friday, October 24, 2008

While Real Doctors Prescribe Placebos, Fake Docs on TV Prescribe Drugs Off-Label

Results of a survey published in the British Medical Journal (BMJ) indicate that "about half of the surveyed internists and rheumatologists reported prescribing placebo treatments on a regular basis." Most often they prescribe harmless vitamins and over the counter analgesics.

"Furthermore," say the researchers, "physicians who use placebo treatments most commonly describe them to patients as a potentially beneficial medicine or treatment not typically used for their condition; only rarely do they explicitly describe them as placebos" (see "Prescribing 'placebo treatments': results of national survey of US internists and rheumatologists").

In contrast, fake doctors on TV, like Gregory House, the protagonist of the hit TV medical drama House, was caught prescribing Lupron off-label for hypogonadism, according to a Pharma Marketing Executive magazine insert article entitled "Drug product placements on TV shows: The Next DTC."

Which is worse?

I think pharmaceutical marketers would prefer the fake doctor's approach, which may explain why PE Mag thinks drug product placements on TV shows are on the rise. It may also be part of a growing trend in what New York magazine calls "product integration -- the latest fad in TV economics, the killer app meant to save TV from TiVo" (see "What Tina Fey Would Do for a SoyJoy").

BTW, before you dismiss product integration as a less effective form of DTC advertising than regular ads, consider this. According to two new studies released by the Kaiser Family Foundation, many television viewers are being educated about important health issues, while being entertained.

The studies found that:
  • Seventeen percent of regular Grey's Anatomy viewers — or about three million people nationwide — said that they had tried to “find more information” about a health issue or “spoken with a doctor or other healthcare professional” because of something they saw on the show.
  • About three in 10 (29 percent) regular Grey’s viewers say they think the medical information on the show is ‘very’ accurate, while another 58 percent say it’s ‘somewhat’ accurate.
  • Health storylines are much more likely to focus on symptoms (65 percent), treatment (59 percent) and diagnosis (50 percent) than prevention (10 percent).
I'll bet if regular 60-second DTC advertisements achieved these kinds of soft metrics, they would be considered very successful. And product placement is so much less expensive -- no advertising agency production fees, for example!

Thursday, October 23, 2008

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.

Wednesday, October 22, 2008

Free Samples: The Drug Rep's Last Great Hope

According to some sales reps, after January 1, 2009 -- when new PhRMA Guidelines for Interaction with Healthcare Professionals (see PMN Reprint #77-01) go into effect -- samples may be the only real form of in-office marketing left.

The drug industry hands out $11.5 billion in free drug samples to physicians every year (2003 number). Although the industry touts free drug samples as a means by which drugs can be made affordable to some needy patients, drug companies must crunch the numbers and pay attention to higher volume physicians with larger managed care opportunities. Samples, for example, can be a strategy to fight certain managed care practices like "step therapy" where a physician is required to first try drugs on formulary and if they fail, then other, non-formulary, drugs may be prescribed. A brand drug strategy for sampling could be to convince physicians that patients will fail on the formulary drugs and when that happens samples of the brand are readily available.

Back to in-office marketing... Samples will not be the only arrow in the sales rep quiver after January 1, 2009. There will still be plenty of allowed activities including free lunch.

A New Loophole for Distributing Free Pens to Physicians
BTW, I have a way in which samples can help drug companies distribute free pens to docs and still abide by PhRMA's guidelines.

Samples are often supplied in starter kits that include all sorts of booklets and other information meant for patients. Often there is just a single pill and the rest is all fluff (ie, patient education materials).

There is no law or PhRMA guideline that prevents pharma companies from distributing starter kits to physicians. No one, I'm sure, looks inside these kits to see that everything is on the up and up. What if these kits included pens and pads with brand logos meant for patients to write themselves adherence messages?

Physicians can simply "redistribute the wealth" by relieving the kits of these "tchotckes" for their own use. After all, many physicians are already using samples for their own use or for use by their friends or staff and their families. Patients won't even know the pens were included in the kits and I'm sure the physicians and their staffs would not rat out the pharma company and expose this clever "loophole."

Cutback in Prescriptions is a Sign of Pharma Recession

In the latest sign that the US pharmaceutical industry is in a recession, the New York Times reports that "through August of this year, the number of all prescriptions dispensed in the United States was lower than in the first eight months of last year, according to a recent analysis of data from IMS Health, a research firm that tracks prescriptions" (see "Some Cut Back on Prescription Drugs in Sour Economy").

Even Lipitor, the best-selling drug in the world, is not exempt: United States sales of that drug were down 13 percent in the third quarter of this year according to Pfizer.

The main reason for this drop in Rx's, according the Times article, is the economy -- to which may I add "duh!" or "stupid!"?

Of course, this hasn't hurt the profits of some companies like Pfizer who have already implemented cost-cutting programs (ie, laid off workers), benefited from a weaker dollar, and decided to focus on much more profitable biologics and/or generics (see "Chantix and Lipitor Sales Fall, But Pfizer's Earnings Rise", "Pfizer plans big push into generics", and "Pfizer exits heart R&D in major overhaul").

The Times article worries that "if enough people try to save money by forgoing drugs controllable conditions could escalate into major medical problems. That could eventually raise the nation's total health care bill and lower the nation's standard of living."

This assumes that there are no alternatives to high-priced brand name drugs like Lipitor. Yo, Times reporter, heard of generics? I've been taking generic pravachol -- NO copay -- for over a year now and though I yearn for the status of taking Lipitor -- the market leader -- I'm not faced with the choice between gas and drugs!

"Yes, I've heard of generics," I imagine the Times reporter responding. "Already, a migration to generic drugs means that 60 percent of prescriptions over all are filled by off-brand versions of drugs [I heard 70% at an industry conference yesterday]. But with money tight, even cheaper generic drugs may not always be affordable drugs."

I can't see how you can get any cheaper than $0. Of course, not everyone has health insurance or a plan that has $0 for generic drug copay like mine. If you are one of those people, I hope you vote for the right person on November 4 is all I can say.

In this economy, drug companies will need to follow Pfizer's lead and re-invent themselves to stay profitable: essentially giving up the fight against generics and cutting back on research into drugs that will eventually become generics. Biologics are much more difficult to "genericize," thus a safer investment.

But that's a long-term solution and until recently investors were not interested in such solutions. Not any longer. See "Investors turn to pharma for yields." While the authors of that article claim the reason investors are turning to pharma is because pharma is traditionally "recession proof," it's more than that. Economists are predicting a very long recession and this time pharma may come out of the recession sooner than other industries.

BTW, have you taken my "Is the Pharma Industry in a Recession Poll?"

Is the Pharma Industry in a Recession?
Not sure
Not yet, but soon
May not be a recession, but it's hurting!

Monday, October 20, 2008

Merck's Goal: "One Less" Gardasil Marketing Problem

Merck is trying to market its cervical cancer vaccine Gardasil to women who may not benefit from it after U.S. sales shrank in July and August, according to a Bloomberg article (see "Merck Aims Gardasil to Women Least Likely to Benefit").

This is in response to a 33% decline in sales.

As pointed out by Jim Edwards over at Bnet "Merck is simply adjusting its strategy to the inevitable grind of numbers: As more girls get the shot, its remaining market declines — and thus Merck must target increasingly marginally profitable populations" (see "At Merck, Desperation Sets in Over Gardasil").

Merck clearly is trying to market Gardasil like a drug for long-term medical conditions such as high cholesterol. In fact, according to the Bloomber article:
Merck "is counting on Gardasil to help offset declining sales of cholesterol pills Vytorin and Zetia after a January study found they may work no better at unclogging arteries than a cheaper medicine. Sales of the asthma treatment Singulair, Merck's top-selling drug, have also slowed over safety concerns."
"Gardasil needs to be doing better," said Barclays Capital analyst Tony Butler in New York, in a telephone interview. The vaccine "has become increasingly more important from a profit standpoint because of the concerns over Singulair and Vytorin and Zetia."
Even though 75% of the most effective market for Gardasil (teenage girls from 13 to 17 years old) has not received a dose of Gardasil, Merck would rather focus on women ages 19 to 26, who have been less likely to get the shots than try to go after teenagers.
"We see tremendous opportunity," said Bev Lybrand, Merck's senior vice president of vaccines. "We have a number of programs under way to get after these women." [My emphasis.]
Gardasil's Marketing Problems
Gardasil has difficulties that marketing must overcome. These include price, effectiveness, and possible dangerous side effects (the CDC said it has received reports of 21 deaths and almost 10,000 side effects in women following vaccination). The latter is an especially difficult hurdle if you have to target mothers of teenage girls rather than the girls themselves -- it's taboo and even illegal in some cases to market to minors under the age of 18. For example, Merck cannot do direct mail or email marketing to teenagers by collecting names and postal/email addresses. That needs parental permissions.

Previously, Merck tried to avoid marketing Gardasil altogether by bribing state legislatures to make HPV vaccination mandatory for school girls. That backfired spectacularly (see "Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question").

It's much easier to market to women older than the age of consent. With these women the biggest obstacle is price. This age group is prone to lack medical insurance to cover the price of drugs. And, as mentioned above, public health experts feel it is not cost-effective to treat women in that age group. Merck will try to convince doctors otherwise. I predict, however, that Merck marketers will have a hard row to hoe with the 19-26 age group.

Obviously, Merck also feels the same way. "Merck," reports Bloomberg, "is seeking Food and Drug Administration approval to market Gardasil to women through age 45." Now we're talking about marketing's sweet spot!

Thursday, October 16, 2008

eMarketers Make a Comeback Inside Pharma

Since the Internet bubble burst sometime around 2000-2002, eMarketers inside pharmaceutical companies have been systematically purged -- either they have been "integrated" into brand teams and effectively stymied or they have been laid off or forced into early retirement. It became very difficult to find anyone inside pharma with "e" in their job titles. In fact, having such a title was considered detrimental to your career within pharma.

I have pointed out that recently several friends inside pharma who have lead eMarketing campaigns have left their positions (see "Friends in the Pharma Industry are Losing Their Jobs"), which I attributed to the current recession within the industry (76% of respondents to my poll -- see left sidebar -- agree that the drug industry is in a recession).

Yesterday, however, my pessimism about eMarketers inside pharma was tempered somewhat when I met several members of this dying breed at exl Pharma's 2nd Annual Digital Pharma conference in Princeton, NJ. Some are even hiring!

The audience was chock full of pharma people, which is rare at industry conferences these days. That is, most often vendors far outnumber pharma people.

Many people recognized me from my photo on this blog and came up to me to say hello and how much they enjoyed reading this blog. Most were pharma people and a couple of them admitted that one or two things I said here caused quite a discussion among their team members. They meant it as a compliment and I am gratified to learn that I am helping bring forward important issues that deserve discussion within pharma.

I'll have more to say about the Digital Pharma conference later. Meanwhile, I am heading off today to moderate a roundtable discussion of ROI and Closed Loop Marketing at the Pharma Force conference in Philadelphia. If you are attending that conference, I hope to meet you there!

Wednesday, October 15, 2008

Results are In: Pharma Favors Obama

It's official! If the presidential election were held today, 55 percent of employees of pharmaceutical companies said they would vote for Mr. Obama and 28 percent said they would vote for Mr. McCain.

These are the latest results (results as of October 9, 2008) from the Pharma Marketing News "Who's Better for Pharma: Obama or McCain?" online survey, which is the only survey that is specifically targeted to a broad range of professionals working within and for the pharmaceutical industry.

You can read a summary of the results to date from the survey in the October, 2008 issue of Pharma Marketing News (download the article at no charge here: The survey is still available here and you can access the latest results -- minus identities of respondents and their open-ended comments -- up to election night here.

Obama is also favored by a majority of vendor/agency employees (57%) and consumers (60%) as shown in the chart on the left.

Breaking the results down according to level of support for the pharmaceutical industry, Obama is the favorite among both the supportive and unsupportive/neutral camps (see Figure 4 in article).

Obama also leads McCain 48% to 43% among respondents who claimed to be “very supportive” of the drug industry.

The latest New York Times/CBS News poll of probable US voters found that if the election were held today, 53 percent of voters said they would vote for Mr. Obama and 39 percent said they would vote for Mr. McCain (see "Poll Says McCain Hurts His Bid by Using Attacks"). This is consistent with the overall results of the Pharma Marketing News survey, where 57% of US respondents said they plan to vote for Obama and 32% for McCain.

Thursday, October 09, 2008

Bottom Drops Out of Market: Buy! Buy!

FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?

As reported in today's AdAge, "Bayer Healthcare Pharmaceuticals is pulling a 60-second ad for birth-control pill Yaz. The move comes after the U.S. Food and Drug Administration expressed concerns that two ads for the drug go too far in suggesting the drug could help overcome PMS and acne" (see "Bayer to Pull Yaz Ad After FDA Warning").

The FDA criticized the ad, 'Balloons,' which is still in rotation and can be seen on the YAZ product website (see image above; click for enlarged view). "The warning letter said that while Yaz had been approved as a contraceptive and a treatment for PMDD (premenstrual dysphoric disorder) and in some cases for acne, the TV ads could be viewed as suggesting the drug also remedied PMS and broader conditions of acne."

This broadcast DTC (direct-to-consumer) ad has been around for quite some time and I'm sure everyone that Bayer wished to reach by the ad has seen it at least once, maybe several times. So, this warning letter is just another example of the FDA closing the barn door after the cow has left (see, for example, "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!").

But, more importantly, the FDA clearly reviewed the storyboards for this ad long BEFORE it was aired. In fact, FDA offers the storyboards as evidence along with the warning letter on its website. I've captured part of the storyboard that shows the balloons:

My question is this: If the FDA is going to preview broadcast DTC ads AND get paid to do it, why didn't the agency stop the YAZ ad from being produced or aired after seeing this storyboard? Is FDA THAT slow in issuing warning letters? Or is it in cahoots with drug companies to help them avoid complying with regulations? Who needs a regulatory agency that regulates AFTER the fact and not before?

This can only get WORSE when drug companies routinely pay for FDA to preview their ads.

Wednesday, October 08, 2008

Pharma PAC Donations to McCain Increasing Faster Than Donations to Obama

Back in September, I noted that Pharma PAC contributions to Obama was growing faster than contributions to Obama (contributions to Obama grew by 6.1% between August and September, whereas contributions to McCain grew by 4.6% during the same period (see "Pharma Money Continues to Pour Into Obama's Coffers").

Now, however, the pharma PACs seem to be trying to play catchup. For the period between September 29 and September 2, PAC contributions to McCain increased 14.1%, whereas contributions to Obama increased only 13.2%. That's not much of a differential, but it's a reversal of trend that may signal a shift toward McCain by pharma folk?

Is Obama better for pharma? What do YOU think? Who do you intend to vote for?

If you haven't given me your opinion on Obama vs. McCain yet, please take 2 minutes to respond to the survey, which you can find here. If you have already taken the survey and wish to change your response (especially if you were undecided before and have now made up your mind who to vote for), you can go back and change your response as long as you are using the same computer and have not deleted cookies.

As always, you can remain anonymous or you can identify yourself if you wish to be quoted in a Pharma Marketing News article I plan to write for the October, 2008 issue. I keep all comments confidential and, if I quote someone, I always let them review it before publication.

The Erectile Projectile: A New Form of Outdoor Advertising

"You don't tug on Superman's cape," says Jim Croce, and you don't mess around with Pfizer! That's a lesson some guys from West Babylon, NY (ie, Long Island) learned when they parked a missile emblazoned with the Viva Viagra logo in front of the Pfizer headquarters in NYC (see Pharmalot for the story about the lawsuit Pfizer has initiated against the West Babylon guys).

The "guys from West Babylon" actually have a company called JetAngel, which intends to put logos on a number of different types of military ordinance. JetAngel's concept “takes the target marketing capabilities of mobile billboards and adds an experience for consumers to achieve the ultimate viewer captivation. It is a new, non-traditional outdoor medium that has no competition. We can capture the consumer’s attention and engage them one-on-one with an advertising message that has proven to provide a positive reaction.”

The company's quaint website is chock full of images of military projectiles parked in a West Babylon backyard. But you won't find the Viva Viagra missile among them.

Instead, I found this Levitra missile appropriately displayed attached to one of the guys (see image on left). Bayer, which markets Levitra, is no Superman in the pharmaceutical pantheon and that may explain the switcheroo. Or perhaps these guys are geniuses of word-of-mouth litigation marketing!

JetAngel's "Corporate Offices"
When I first saw this and other photos on the JetAngel website, I was sure the location was somewhere on Long Island, maybe even Brooklyn, NY, where I lived as a kid. West Babylon is not that far off.

Just for fun, I located JetAngel's "Corporate Offices" using Google Earth and just as I suspected, it is located in a middle-class suburban residential neighborhood.

I wonder what JetAngel's neighbors think of all the missiles and other projectiles parked next door? The guys from West Babylon may have many more lawsuits to contend with before they make any money from their "new, non-traditional outdoor medium that has no competition."

Sung to the tune of "You Don't Mess Around With Jim":

Uptown got its hustlers
Bowery got its bums
And 42nd street got big Pfizer Pharma
It's a pill poppin' son of a gun
Ya, it's big and dumb as a drug company can come
But stronger than a suburban backhoe
And when the bad marketing folks all get together at night
You know they all call big Pfizer's ceo, just because, and they say

You don't tug on Superman's cape
You don't spit into the wind
You don't pull the mask off the old Lone Ranger
And you don't mess around with Pfizer, da do da do...

Well out of West Babyon come a suburban guy
He said, "I'm looking for a company named Pfizer
I am a pill poppin' ad boy, my name is JetAngel, the real OOH McCoy
And I'm looking for the king of 42nd street
Last week he took all my mom's money, and it may sound funny
But I've come to get her money back in advertising," and everybody said, Jack, don't you know

You don't tug on Superman's cape
You don't spit into the wind
You don't pull the mask off the old Lone Ranger
And you don't mess around with Pfizer, da do da do...

Well a hush fell over pharma land
When big Pfizer come boppin' off 42nd street
And when the cuttin' was done
The only part that wasn't bloody was the soles of JetAngel's feet
And you better believe they did NOT sing a different kind of story
When JetAngel hit the floor

You don't tug on Superman's cape
You don't spit into the wind
You don't pull the mask off the old Lone Ranger
And you don't mess around with Pfizer, da do da do...

(I changed the outcome -- the "Big Guy" wins, as in real life.)

Tuesday, October 07, 2008

Pfizer's New Focus Will Usher in a Golden Age of Pharma Social Media Marketing

Pfizer recently decided to abandon its efforts to develop medicines for heart disease and focus instead on more-profitable areas, such as cancer and Alzheimer's disease.

It was noted that this plan saves money because Pfizer could cut jobs in R&D and presumably buy the technology it needs from biotech startups.

Also at stake, however, are traditional marketing and sales jobs.

Here's how I see it.

Pfizer's new focus is on biotech and other drugs that are complicated and need to be delivered or prescribed by specialists. There are fewer of these specialists than general practitioners, which means that fewer sales reps are necessary to sell to them. Also, institutional sales will become much more important. This takes advantage of the economy of scale -- fewer reps are needed to service an institution than a individual medical practices.

Also, the number of patients for these treatments are measured in the hundreds of thousands versus tens of millions for patients taking anti-cholesterol pills -- the market is at least an order of magnitude smaller.

Which means much less broadcast DTC (direct-to-consumer) advertising is justified. After all, why waste millions to reach thousands?

All this is good news for non-traditional marketing; ie, targeted marketing, direct mail, and Internet-based marketing and especially social media marketing.

Patients, caregivers, and physicians interested in specialty drugs for cancer and Alzheimer's disease are much more active online than are Lipitor patients and general practitioners. That's why I think Pfizer will usher in a golden age for pharma social media marketers!

Discuss. First, however, you may wish to purchase the "Social Media Pharma Marketing" Supplement to Pharma Marketing News. Click here for more details -- including a table of contents and link for ordering the pdf file online. If you order it, use the discount code SMM444JM and get $17 knocked off the list price of $29.95!

Monday, October 06, 2008

As I Predicted, Drug Samples Under Attack!

First it was direct-to-consumer (DTC) advertising, then free gifts to physicians, followed by pharma-funded continuing medical education (CME). Now the distribution of free Rx drug samples to physicians by pharmaceutical companies is being attacked by physicians and reported in main stream news media. I warned of this back in August 2008 (seems like ages ago!) in the post "What's Next: Ban Free Drug Samples?"

As reported today in the New York Times (see "Study Says Drug Samples May Endanger Children"), "a new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children’s health at risk." The study was done by a Harvard Medical School researcher who analyzed an in-depth survey conducted in 2004 by the Centers for Disease Control and Prevention.

A previous study done by research at Wake Forest University Baptist Medical Center found that "physicians are over three times more likely to prescribe generic medications to uninsured patients when drug samples are not available; however, patients with comprehensive drug coverage (Medicaid) received a high proportion of generic prescriptions regardless of sample availability." (See "Drug Samples: To those that have, it shall be given. The rest pay list price!")

PhRMA is Silent -- How About You?
Both these studies are bouncing around lesser media outlets and the Pharma Blogosphere, but so far I have not heard any official comments from the pharmaceutical industry (ie, PhRMA).

I offer PhRMA and ALL readers of this blog and and my newsletter -- Pharma Marketing News -- a chance to sound off on issues relating to the distribution of free Rx drug samples by the pharmaceutical industry. You can do this by taking the Pharmaceutical Sampling Practices Survey, which asks if you agree or disagree with following statements:
  • Samples encourage physicians and patients to rely on medications that are expensive, but often not more effective than other available drugs.
  • Physicians value samples and are willing to spend time with sales representatives to get them.
  • Samples serve PRIMARILY as an enticement to prescribe new, heavily marketed and generally more expensive medications.
  • Distribution of samples to low-income or uninsured patients is of limited utility in reducing the burden of high drug costs for these patients.
  • Considering the other limitations being placed on pharmaceutical sales reps -- eg, no free gifts to physicians -- samples are the BEST way for sales reps to gain access to physicians.
  • Banning the distribution of free samples to doctors by pharmaceutical sales representatives will be detrimental to patients (eg, patients will be forced to fill a prescription for a drug that may not be tolerable or efficacious for them).
  • Samples are an essential component of physician marketing and assure market share growth for the drug. That is, without free samples, it is less likely that doctors will prescribe the drug as a first choice.
I also welcome your comments.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally. (The results of this survey will be published in the November issue of Pharma Marketing News.

After taking the survey, you will be able to review a de-identified summary of results.

Please take the Pharmaceutical Sampling Practices Survey

Friday, October 03, 2008

DTC Pundit Throws in Political Towel

Bob Ehrlich, Chairman of DTC Perspectives, admitted today in his e-mail OpEd piece that "It looks increasingly likely we will have a Democratic victory in November." (You may find the totality of Ehrlich's comments here.)

The results to date of my McCain v. Obama survey seem to confirm Bob's fears: 55% of the 229 US respondents said they would vote for Obama, whereas 34% plan on voting for McCain. Looking at only US respondents employed at pharmaceutical companies, the numbers are 54% and 30%, respectively. Among the 179 US respondents that say they are "very" or "somewhat" supportive of the pharmaceutical industry, 51% said they would vote for Obama and 40% would vote for McCain.

Of course, my survey does not meet rigorous statistical significance, and I do not know the polls upon which Bob may be basing his prediction. But it's interesting to know what my readers are thinking on this subject. So please take my survey and give me your comments.

Bob also made an interesting comment comparing the pharmaceutical industry with the investment banking industry:
"Main Street dislikes drug companies almost as much as bailed out banks. Once the political opportunities wane for attacks on financial companies we can expect drug companies to be a nice juicy target. I do not anticipate any bans on advertising. I do expect much more vigorous enforcement from the FDA on drug company marketing practices."
It's not that we need MORE regulations from the FDA (or from the SEC). What we need is proactive ENFORCEMENT of regulations already on the books. As the New York Times reports ("Agency’s ’04 Rule Let Banks Pile Up New Debt, and Risk"):
"The [Securities and Exchange Commission]’s decision [to exempt investment banks' brokerage units from an old regulation that limited the amount of debt they could take on and] effectively to outsource its oversight to the firms themselves fit squarely in the broader Washington culture of the last eight years under President Bush.

"A similar closeness to industry and laissez-faire philosophy has driven a push for deregulation throughout the government, from the Consumer Product Safety Commission and the Environmental Protection Agency to worker safety and transportation agencies."
The Times could have added FDA to that laissez-faire agency list.
“It’s a fair criticism of the Bush administration that regulators have relied on many voluntary regulatory programs,” said Roderick M. Hills, a Republican who was chairman of the S.E.C. under President Gerald R. Ford. “The problem with such voluntary programs is that, as we’ve seen throughout history, they often don’t work.” - NY Times.
I think it's also fair to say that the public has a dim view of the FDA as evidenced by the fact that the agency is hiring outside PR consultants to improve its image and in typical closed-door Bush cronyism fashion, it surreptitiously bypassed government contract procedures to hire friends of friends (see Pharmalot post).

The coming melt-down of the financial well-being of the pharmaceutical industry will not depend upon Main street's opinion of the industry. It will have more to do with weak pipelines and generic global competition -- some of the same worries that lead investment banks to seek special exemptions from regulations.

And, BTW, there are special tax breaks for R&D dependent industries (eg, pharmaceutical and high tech) in the bailout bill that just passed in the Senate. It just could be deja vu all over again!

Thursday, October 02, 2008

Pharma Dollars (Pounds, Euros) are Grassroots Seeds

I am beginning to believe that in countries like the UK, where direct-to-consumer (DTC) advertising is not permitted, pharmaceutical companies have used the bundles of dough they save by not advertising on the tellie to manipulate public opinion in other, more creative and consumer-centric ways. Such as creating and funding so-called "grassroot" patient organizations that lobby and promote on behalf of their donors.

The most recent example of this is the attacks by patient groups on the National Institute for Clinical Excellence (Nice) over decisions to restrict access to drugs on UK's National Health Service (NHS) formulary (NHS is like Medicare in the US, except it covers all UK citizens). The rising tide of protest over the refusal by the NHS to provide expensive drugs for cancer and other conditions is being funded by the pharmaceutical industry, an investigation by The Independent has revealed (see "Drug firms bankroll attacks on NHS"):
"Patient groups that have been among the most vocal in spearheading attacks on the National Institute for Clinical Excellence (Nice) over decisions to restrict access to drugs on the NHS depend for up to half of their income on drug companies, but details are often undisclosed.

"The growing clamour over decisions by Nice to ban access to certain drugs has outraged patients and the public, and undermined confidence in the NHS.

"Protests have been launched by charities including the National Kidney Federation, the Arthritis and Musculoskeletal Alliance, the National Rheumatoid Arthritis Society, Beating Bowel Cancer, the Royal National Institute for the Blind and the Alzheimer's Society. All of these charities received sums of up to six figures from drug companies in 2007.

"The extent of the drug companies' support for the smaller charities has led to criticisms that supposedly grassroots patient organisations are puppets of the pharmaceutical industry, being used to bludgeon Nice into making the drugs available on the health service. A positive decision by Nice on a drug not only guarantees sales to the NHS but can influence global markets worth billions of pounds.

"Yet none of the charities named has criticised the high prices charged by the pharmaceutical companies for their products in their recent campaigns."
Some time ago, I pointed out that the Restless Leg Syndrome (RLS) Foundation -- a US patient organization -- has very close ties to GSK -- a UK-based company that markets ReQuip for treatment of (RLS). In fact, I believe that the RLS Foundation was established by GSK. Here are some interesting factoids that support my thesis (see "Restless Pharma Marketing", for more details):
  • GSK is a Gold Corporate Sponsor of the RLS Foundation, which means GSK has given the foundation a good chunk of change;
  • at least one member of the Foundation's Medical Advisory Board has financial ties to a pharmaceutical company (GSK) with a treatment for RLS;
  • the PR activity of the organization seems to have picked up right when that company's drug hit (ReQuip) the market;
  • the first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK;
  • Dr. Richard Allen, a member of the RLS Foundation's Medical Advisory Board, had the "pleasure" of "collaborating" with GSK to do studies supporting the data on the prevalence of RLS in the US and in Europe;
  • The color scheme of the RLS Foundation's Web site matches that of the Requip product site.
I guess pharma donations of "up to six figures" -- hundreds of thousands of dollars -- to UK or US "grassroots" patient groups are small peanuts compared to the 9-10 figure sums spent on TV DTC ads. But 6 figures here and 6 figures there, and pretty soon we're talking 7 to 8 figures, right? And six figures worth of advocacy from a targeted patient group is at least ten times more effective than the same amount wasted on DTC ads (see "Is DTC Bankrupting Pharma?").

Yet, all this is insignificant when compared to the 12 figures -- $700,000,000,000! -- that the US government is robbing from the poor to pay the rich.

P.S. Patient groups and healthcare charities whose existence and good work relies on donations from individuals and organisations have denied that they are in any way obliged to fight the pharmaceutical industry’s corner in return for financial support. (see "Charities not in the pocket of pharma").

Wednesday, October 01, 2008

Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!

By the time the FDA issues a warning letter about a DTC ad that violates FDA regulations -- as it did on September 25, 2008, for a video testimonial featuring Ty Pennington posted on by Shire -- the cow has long left the barn.

The FDA letter -- which you can find here -- said "Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use. Additionally, the webpage broadens the indication for Adderall XR by suggesting uses that have not been approved by FDA. Thus, the webpage and video misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act..." blah, blah.

This is at least the second time recently that the FDA has cited an online video ad as violative. The first was a Pfizer Viagra video (see "Violative Viva Viagra Video - Still There!"). That video was misleading, said FDA, "because it makes representations and suggestions about the use of Viagra for erectile dysfunction, but fails to disclose any risk information for the drug." After the FDA letter to Pfizer became news, you could still see the video on its website, but now it is gone.

The Ty Pennington Adderall XR video can no longer be found on YouTube, which proves that Web 2.0 Tricks work! (see "Web 2.0 Pharma Marketing Tricks for Dummies"). I did, however, find another entertaining adult ADHD YouTube video, which you can find at the end of this post.

I am not sure when the Adderall XR YouTube video was removed, but I suspect it was long ago. First, Adderall XR was replaced by Vyvanse some time back. FDA must have known about this and probably wrote the letter before that happened. That it did not send the letter until September must mean that it was tied up in FDA's controversial internal legal review (see "FDA DTC Review: The House that Troy Built"), which allows violative ads to run uninterrupted until the media budget for the ads run out.

Not only that, I also notice that Ty Pennington is no longer the spokesperson for this drug as he was back in October, 2007 (see "J&J Blog, Shire PR: The Whole Story and Nothing But the Whole Story!"). I cannot find him on the Vyvanse website.

Ty Pennington Look-alike Ad
But Shire continues to use a Ty look-alike in print ads (a ploy similar to the "PC Guy" look-alike in Microsoft "I am a PC" TV ads). I found the following full-page Vyvanse ad in a recent issue of Time Magazine.

Clearly, Shire is milking the Ty Pennington franchise for all it's worth, but no longer paying the high celebrity endorsement fees. Maybe Ty did something to fall out of favor with Shire? Like switch over to shilling for Bayer aspirin? Could this be the "Linda Lovelace" Deep Throat effect?

Here's the Adult ADHD video:
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