Monday, February 25, 2013

Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe or Imbibe Any New Drug for First Seven Years After FDA Approval

At the recent Selling Sickness conference in Washington, DC. Sydney Wolfe, MD (Public Citizen), gave a rousing keynote presentation. As I reported last week, Wolfe declared war on the medical-pharma-industrial complex (see here).

One of the main "weapons" Wolfe proposed to help win the war against what he sees as the dangers of FDA-approved drugs is his "Seven-year Rule for Safer Prescribing - No prescribing or imbibing any new drug, except true breakthrough drugs, for the first 7 years after approval." Here's the rule described in Australian Prescriber:
"You should wait at least seven years from the date of release to take any new drug unless it is one of those rare ‘breakthrough’ drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labelling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release."
And here's an auto snippet of Wolfe's presentation that includes the 7-year Rule and other "solutions":


A few observations:

  1. If this rule were scrupulously followed, it wouldn't solve the "problem" because there would be no new safety data to analyze (no one would be taking the drug). Of course, the rule would never be followed by all the people all the time. It will be followed only by some of the people, some of the time. It's usually good advice not to use new technology before it has been on the market for awhile. But, who can wait SEVEN years to try a new drug if there may be a chance it will work?
  2. The Rule allows an exception for "breakthrough" drugs. Of course, pharma marketers always describe the drugs they advertised as "breakthrough" more or less. But I agree that new drugs should be tested against older proven drugs. Unfortunately, the FDA does not require that for approval.
  3. Of course, no new drug would ever be developed by a pharma company if it was boycotted for seven years! By the end of that time, the patent will have expired and there goes the profit!
"People Before Profits" was the underlying theme of the Selling Sickness conference. Wolfe's 7-Year Rule would certainly kill profits, but it may also kill people (or keep them sick).

P.S. In a comment to this post, Medskep asks: "Please provide some examples of new Rxs that proved to be so effective that lives were clearly saved in the first seven years." I don't have specific data about that. It's difficult to prove that drugs save lives. It is easier to prove that Wolfe's argument has some merit in that many of the drugs his organization petitioned FDA to remove from the market have subsequently been removed -- mostly within 7 years of Wolfe's petition. Wolfe demonstrated this in the following table taken from his presentation (find the his presentation attached here):

(Click on image for an enlarged view)

Friday, February 22, 2013

Selling Sickness: The War Against the Medical-Industrial Complex

I am a fish out of water here at the 2013 Selling Sickness conference in Washington, D.C. Although the theme of the conference -- "People Before Profits" -- resonates with a lot of public relations rhetoric of big pharma companies (e.g., "Merck. Where patients come first"; see here), the speakers and attendees at this conference REALLY mean it!

I'm an outsider here because I am a pharma "insider" in their view. And, as keynote speaker Sidney Wolfe, MD (Public Citizen) said: "we [they] are at war with the pharmaceutical industry." Or maybe he said the "medical-industrial complex," which was how a number of speakers characterized the relationship between the drug industry, medical professionals, and the FDA. Here's Wolfe and other keynote speakers, Jeanne Lenzer (immediate right to Wolfe) and Shannon Brownlee (journalists):


I am not sure if Leonore Tiefer and Kim Witczak (@woodymatters), the conference organizers, invited any pharma representatives to speak or attend this conference. That would have been interesting if there were any pharma guy or gal brave enough to accept. But, I don't want to cast this in too much of an "us vs. them" light because pharma should try to open up a dialogue with the patient advocates, caregivers, doctors, nurses, public health people, and academics who attend this meeting. It will give them a new sense of what "patient empowerment" really means.

Many attendees I met were caregivers with close relatives who they believe have been victims of the "medical-industrial" complex. Kim Witczak's husband Woody, for example, died of a "Zoloft-induced suicide" at age 37 (see here). Ginger Taylor (@GingerTaylor), VP of the Canary Party, has a son -- Chandler -- who "regressed into autism following his 18 month vaccinations." I put these claims in quotes because as "we" all know, there is no proof that drugs and vaccines cause such harm.

But what we "know" may need to be revisited. When I tweeted a stat Wolfe dropped during his presentation that "adverse drug deaths is 3rd leading cause of death in US," Adam Jacobs (@dianthusmed) responded: "Hasn't that "3rd leading cause" statistic been debunked many times over?" And when I told Ginger that the study linking autism to vaccination was a fraud, she responded with several other studies that "prove" a link, studies that she says the media do not mention.

Any way, I have to go. The second day here at Selling Sickness is about to start. I have embedded the #sellingsickness Twitter chat stream below. Hopefully it works and you can follow the conversation.

Wednesday, February 20, 2013

The First Ever "Dear Doctor" Letter Regarding a Mobile Medical App Recall

When I wrote the Pharma Marketing News article "Some Unregulated Physician Smartphone Apps May Be Buggy" back in January 2012, I reported that Pfizer "recalled" its Rheumatology Calculator app because of "a bug in the app ... gives wrong results."

Considering that the "recalled" Pfizer app was the most downloaded app tracked by POCKET.MD at the time, there must be many many users (physicians) out there who still have the app on their phones. At the time, I asked "Did Pfizer send these physicians a 'Dear Doctor' letter informing them of the problem and advising them to remove the app from their phones?" My best guesstimate answer at was: "Probably not."

It turns out, however, that Pfizer UK DID send out a "Dear Doctor" letter in October 2011, warning doctors that:
“the Apple iPhone application gives on average a 15-20% higher score for DAS28-ESR compared to a score calculated using the published DAS28-ESR formula (with higher or lower incorrect scores in certain cases). It gives on average a 10-15% lower score for DAS28-CRP compared to a score calculated using the published DAS28-CRP formula2. Incorrect values are also obtained for the ASDAS-CRP score (scores are on average 15-25% lower) and for the PASI score (scores are up to 50% lower). There may also be minor errors in the Framingham scores.”
You can access a copy of that letter here and see a screen capture of the first  page below. I believe this is the first ever "Dear Doctor" letter regarding a mobile medical app recall.  Many physicians and consumers may believe that mobile health apps developed by pharmaceutical companies are accurate and reliable, but as this case demonstrates, that may not be so.

Shouldn't the pharma industry develop best practices for mobile apps to assure that they are rigorously tested before they are made available to doctors and consumers? This is a topic discussed in this Pharma Marketing News article, published today: "Reigning in the 'Wild West' of Mobile Health Apps" (subscription required). The articles reviews the results of the Regulation of Pharma Health Apps Survey.


The first ever "Dear Doctor" letter regarding the recall of a mobile medical app (click to enlarge).

Monday, February 18, 2013

Novartis Preserves Vasella in Aspic

Daniel Vasella, chairman and chief executive of Novartis, should not have accepted a $78m payment, according to th Financial Times (here).

Mr Vasella “has agreed to continue to make available his knowhow to Novartis and to refrain from activities that compete with any business of Novartis for a multiyear period.” That reads like a sweeping gag order, says the FT.

"The loser, though, is the pharmaceutical industry," says FT. "After 17 years in charge, there is little more he can offer Novartis. His wealth of experience would be better employed advising start-ups and on new drug development. Instead, it will be preserved in aspic inside Novartis."

I thought the "preserved in aspic" comment deserved a visual rendering:


I'm not sure what the shelf-life of foods preserved in aspic is, but Vasella's shelf-life deal runs for 6 years.

Update: The shelf-life turned out to be less than 1 day! See "Novartis Board of Directors and Dr. Daniel Vasella agree to cancel the non-compete agreement and all related compensation" (here). The decision, Novartis said, was taken "to address concerns of stakeholders." But I think the image of Vasella preserved in Aspic is what did the deal in. Talk about an image worth a thousand words... the above image may have been worth $78 million!

Saturday, February 16, 2013

ED Drug Advertisers "Cockblocked" PhRMA's DTC Guiding Principle #13

The pharmaceutical industry's efforts to self-regulate its direct-to-consumer (DTC) advertising are "an industry-sponsored ruse," intended to deflect criticism and collectively block new Federal regulation, a study released today in the Journal of Health Politics, Policy and Law found. The paper, "The Politics and Strategy of Industry Self-Regulation: The Pharmaceutical Industry's Principles for Ethical Direct-to-Consumer Advertising as a Deceptive Blocking Strategy," which you can find here, was written by Denis Arnold, Associate Professor of Management and Surtman Distinguished Scholar in Business Ethics in the Belk College of Business at UNC Charlotte, with Jim Oakley, Associate Professor of Marketing at Montana State University.

Arnold and Oakley studied the marketing campaigns for erectile dysfunction (ED) drugs -- Viagra (Pfizer), Cialis (Eli Lilly), and Levitra (Bayer Healthcare, GlaxoSmithKline and Merck) -- over a four-year period, 2006 to 2010. They found that a substantial percentage of TV ads for these products violated Principle 13 (audience composition) in the original 2006 “PhRMA Guiding Principles”, which requires that audience composition be 80 percent adult (eighteen years and older) for advertisements with adult-oriented content. This principle was in effect from January 1, 2006, to March 1, 2009. Here's a chart from the study:


According to PhRMA's revised guidelines, it is now expected that 90 percent of the audience for these advertisements will be eighteen years or older. "At no point have the three brands in this category successfully complied with this guideline at a rate better than 50 percent for the total category," contend the authors of the study.

According to some experts, self-regulatory guidelines such as PhRMA's DTC guidelines represent a "bridging" strategy in which firms take the proactive internal measures necessary to meet external expectations. "This might be accomplished by meeting and exceeding regulatory requirements or by voluntarily implementing self-regulatory standards within an industry," note the authors of the study.

Self-Regulation as a Collective Blocking Strategy
The authors of this study, however, characterize what ED drug advertisers are doing as a "blocking" strategy, which "occurs when a firm publicly characterizes itself as engaged in bridging activity but is in reality engaged in activity that blocks unwanted external constraints on its activities. When a firm engages in a blocking strategy, it represents itself as responding proactively to social expectations about firm behavior in a manner consistent with a bridging strategy but does not implement the internal measures necessary to ensure that the bridging strategy is implemented."

The authors go even further, accusing the industry of engaging in a deceptive collective "blocking" strategy, which has the following components:

  1. it is facilitated by an industry trade group via an industry-wide code of conduct, 
  2. it is a response to the perceived threat of additional regulatory oversight, 
  3. the code of conduct is routinely violated by companies that have agreed to follow the code, and 
  4. the code of conduct is not enforced by the trade group.
I can vouch for #3 and #4, having posted several instances where drug advertisers have violated PhRMA's DTC Guiding Principles with nary a word from PhRMA's "Office of Accountability," which was created to receive and process public comments about company compliance with the principles.

Speaking of PhRMA's "Office of Accountability," the authors attempted to file comments with that office for each erectile dysfunction pharmaceutical brand:
"We submitted comments by mail on March 22, 2010. After six weeks and no response, we resubmitted our comments by mail and obtained confirmation of delivery on May 6, 2010, by the US Postal Service. We also made repeated efforts to submit comment forms by facsimile beginning in May 2010, but the incoming calls at the number provided by PhRMA were not picked up by a facsimile machine on different days and at different times. We continued this effort until July 23, 2010, when on the eleventh attempt a facsimile was confirmed as delivered. In the meantime, comments were again mailed to the PhRMA Office of Accountability on July 13, 2010. No response to any of these comments was ever received from PhRMA or from Bayer Healthcare, Eli Lilly, GlaxoSmithKline, Schering Plough, Merck, or Pfizer as of December 27, 2012."
They should have known this would happen after my own attempts to submit comments to PhRMA resulted in a strange delayed response from the famed "PhRMA Intern" (see "PhRMA's Response - PRwise, it Stinks!"). Recall the envelope that the response came in:


PhRMA's "Office of Accountability" is the ultimate "cockblocker" for complaints about violations of it DTC Guiding Principles.

The Adventures of PhRMA Intern!



Stay tuned for the further adventures of PhRMA Intern!

Friday, February 15, 2013

When It Comes to Privacy, Purdue Is as Old-fashioned as an Incandescent Light Bulb!

"Recognizing the power of DTC to drive scripts, Purdue has seen the light," notes MM&M commentator Deborah Dick-Rath. "Or light bulb, I should say, since they are using a friendly, animated old-fashioned light bulb as their key brand icon."

I haven't seen the 90-second TV ad yet, but as I mentioned previously (here), I received Intermezzo spam e-mails. Here's part of one e-mail message that I received:


The light bulb may be sad because it knows its days are numbered. Production of the 100-watt and 75-watt versions of incandescent light bulbs is already at an end. "Next January, the 40- and 60-watt incandescent bulbs will go, and after store supplies sell out, that will be the end of your grandfather's type of bulb in the U.S. forever," notes the Savvy Consumer (here).

From the looks of it, the Intermezzo bulb looks like a 25-watter. Are they still available? In any case, the lifespan of the Intermezzo bulb may be several years! Obviously, the incandescent bulb will be an icon that will live on, especially in the minds of older folk who likely to wake up in the middle night from nightmares about pending Medicare cuts.

Back to the Intermezzo e-mail campaign. I received 3 separate e-mails, two of which called me "Mike." Not a very well-targeted campaign. Obviously, these were unsolicited e-mails; i.e., spam, and I quickly attempted to "unsubscribe" by clicking on what looked to be the "unsubscribe" link (i.e., "unsubscribe here" in this section of the email):



But the link did not work; in fact, it wasn't a link at all.

So I called Purdue and tried to talk to someone who could help me find out why I got these emails, explain why the unsubscribe link doesn't work, and to get off the mailing list. Surprisingly, there is no privacy office at Purdue that you can call about such matters. In that regard, Purdue -- like the Intermezzo brand icon -- is your grandfather's type of pharma company.

The only person at Purdue who offered to help me was a pharmacist in the medical services department. Keep in mind that these people are there to answer questions from healthcare professionals about Purdue products. Nevertheless, she contacted the marketing people and confirmed later that I was no longer on the mailing list.

It appears that I am the only person who called to complain about the unsubscribe problem, which the Purdue marketing people said is "now working."

Although I reached someone who was very helpful dealing with my problem,  I feel the need to talk to someone in the legal department who is responsible for their privacy policies and procedures. I'm waiting for that person to call me back.

An Anti-DTC Crossword Puzzle: What's Next?

One of my daily routines is to solve 2 or 3 crossword puzzles using the "Crosswords" app on my iPad. I'm not among the TOP 100 solvers in the "Leaderboard," but I just do it for fun and to exercise the brain. I've heard that this sort of thing can help prevent Alzheimer's disease.

Speaking about health, the theme of today's Newsday crossword puzzle was "HEAL THYSELF?" "Ah ha!," said I, "I should be able to solve this one quickly and be among the top ten!" But the clues were a bit tricky and I wasn't able to get it 100% correct without some hints.

But I was able to solve the theme message of the puzzle, which was a three-part quip. It turns out that this was an anti TV drug ad quip as shown in the screen shot of the puzzle below:


The quip is highlighted in blue: "ASK YOUR DOCTOR IF TAKING MEDICAL ADVICE FROM A TV AD IS RIGHT FOR YOU"

Of course, this quip is a takeoff of the call to action of every direct-to-consumer (DTC) TV ad: "Ask Your Doctor if [INSERT BRAND NAME DRUG HERE] is right for you."

These days, you never know where you are going to run into anti DTC sentiment. First, it's a former pharma president (see "Drop TV Ads, Says John LaMattina, Former Pfizer President of R&D"). Now it's a crossword puzzle author. Where will we see it next? Congress? Time will tell.

Thursday, February 14, 2013

Fish Psyched Out on Drugs!

"Traces of human medicines could be damaging the ecology of streams and rivers, according to a Swedish study," reported FT Science (here). Specifically, fish exposed to "relatively low concentrations" of oxazepam -- a frequently prescribed drug used to treat anxiety -- changed the fish’s behaviour, making them "bolder and less sociable." Fish in the experiment had amounts of oxazepam in their flesh similar to wild perch in Sweden’s River Fyris.

“While alone, fish that were exposed to oxazepam dared to leave a safe refuge and enter novel, potentially dangerous areas,” said Tomas Brodin, the study leader.

I was able to obtain an artist's rendering of one such fish:



“In contrast," said Brodin, "unexposed fish stayed hidden in their refuge."

Although researchers said oxazepam exposure might be harmful to the fish in the wild, they also admitted that the exposed fish "seemed much less stressed and scared," which could be a good thing, especially if you want to knock down those underwater structures built by the CATS!

But all seriousness aside, this is a problem that should be dealt with. Either you can stop overmedicating people with drugs like oxazepam, or you can get your Congressman to support Obama's infrastructure plan and develop sewage treatment plants that can capture environmentally hazardous drugs. Ha! Neither are likely to happen any time soon here in the U.S. Sweden? Maybe they'll do the latter.

Tuesday, February 12, 2013

Middle-of-the-Night Insomnia: Purdue's Subjective Symptom Quiz v. My Quantified Self

I just received an email ad from Purdue Pharma entitled "Learn about a prescription treatment specifically for middle-of-the-night insomnia." It's an ad for Intermezzo, "the first and only prescription sleep aid approved by the FDA for use as needed to help treat adults with insomnia when they have difficulty falling back to sleep after waking up in the middle of the night."

That last part, which I italicized, is a mouthful. So Purdue came up with "Middle-of-the-Night Insomnia," a new name that makes it sound like an "official" medical condition.

In case you don't know if you suffer from "Middle-of-the-Night Insomnia," Purdue included a little "symptom quiz" in the email:


(click to enlarge)

As with most such quizzes, practically everyone will end up discovering they "may" have the condition (see, for example, "Do Pharma Marketers Encourage Consumers to Self-Diagnose?"). Of course, Purdue was careful to assure me that this is NOT a diagnostic tool.

These days, however, any law-abiding citizen such as myself can get access to a diagnostic tool that will answer all Purdue's questions UNEQUIVOCALLY! It's called UP by Jawbone. UP is "a uniquely trendy wrist-worn pedometer" that communicates with my iPhone. It resembles a black Livestrong-style bracelet -- except it's not tainted by doping controversy. Here's what it looks like on my wrist:


When I sync the UP bracelet with the associated app on my iPhone, I get data and charts about my daily activities, including my sleeping habits. The night before last, for example, UP recorded this:


I wasn't feeling too good (see my comment), so I went to bed rather early (8:43 PM) that night. It appears that I fell asleep rather quickly, but not on my own -- I took some NyQuil. I went in and out of deep sleep all night because of a sore throat and I even woke up at one point -- probably to blow my nose. It appears, however, that I was able to get back to sleep, but I am not sure this chart indicates I had "trouble" doing so.

For me, UP replaces an app called "Sleep Cycle" that I once used to measure my sleep patterns (see here). Wearing a bracelet is better because I don't have to place my iPhone on the bed or start up an app to start recording. Also, the bracelet measures what I do personally, not what anyone else in the bed is doing, which was a problem with Sleep Cycle.

Now that I am part of the "Quantified Self" movement, which refers to people who incorporate technology to capture data about their daily activities, I don't have to rely on Purdue's subjective little symptom quiz to help me talk to my doctor about my sleep patterns -- I can just show her the charts on my iPhone!

I need to make a couple of other points about Purdue's email marketing message.

In marketing, one always hears advice to deliver "the right message to the right person at the right time." Purdue got two of them right -- the right message was delivered to me at the right time. Unfortunately, the email was addressed to "Mike." There's no "Mike" here.

I also hear "reach and frequency" mentioned in marketing circles. I don't know how many people Purdue "reached" with this email ad, but I do know that I received THREE identical messages within one hour. I think that's not an effective implementation of the frequency principle.

Since the message was not personalized and since I am receiving multiple messages, I can classify this campaign as SPAM - unsolicited, frequent email. Although the message includes the required opt-out statement -- "If you no longer wish to receive e-mails from myIntermezzo.com, unsubscribe here." -- there is no active link and clicking on "unsubscribe" or "here" does nothing.

Purdue's privacy policy says my information is stored for the "lifetime of the database unless you request that it be removed." The only recourse I have, it seems, is to call them by phone. I will leave THAT for another day and another post to this blog.

Monday, February 11, 2013

GSK: The Claes Oldenburg of Pharma

I should be in Philadelphia today attending CBI's iPharma conference, but I think I have the flu despite getting the flu vaccine, which I recently learned is only 62% "effective" (see here). Well, "effective" means it will keep me from seeking medical treatment, but unfortunately, it won't keep me from missing this conference.

If I were in Philadelphia, however, I may pass by the famous Claes Oldenburg Clothespin outdoor sculpture in front of cit hall on my way to the conference. You've probably seen it yourself:



Cleveland City Hall is also "graced" with an Oldenburg sculpture; i.e., a FREE ink stamp:



"Many of Oldenburg's large-scale sculptures of mundane objects elicited public ridicule before being embraced as whimsical, insightful, and fun additions to public outdoor art," according to a Wikipedia entry.

GSK recently launched a recycling program that includes an "Oldenburg-esque" large-scale sculpture of a mundane object -- a metered dose inhaler! Here is a photo of the sculpture in Victoria Station, London:


"Today sees the launch of the first ever UK-wide inhaler recycling and recovery scheme – Complete the Cycle," announced GSK on Facebook. "The scheme encourages all inhaler users to return old devices to a participating pharmacy rather than send the devices to landfill."

"Our inhalers produce 5.2 million tonnes of CO2 emissions, and are the second biggest contributor to our global footprint - just after the transportation aspects involved in making and supplying our products around the world," says GSK (here).

The sculpture seems like it is capturing minimal attention from Victoria Station visitors of which there are 1.5 million per week! The photo shows one person eying the sculpture wondering what the hell it is?

But it's not the inhaler itself that contributes to GSK's global carbon footprints. 95% of the footprint produced by these inhalers is a result of the propellant it releases into the atmosphere. Even Claes Oldenburg would be challenged to sculpt propellant!

P.S. Why green? I think the actual inhalers come only in beige like old-style personal PCs. Claes would not approve!

Monday, February 04, 2013

Baby Boomers Living Longer, But Less Healthy Lives!

I just read some surprising results of a study published in Arch Intern Med. (2013;173(2):1-2) regarding the overall health status of aging baby boomers compared with the previous generation. The authors analyzed data from the National Health and Nutrition Examination Survey (NHANES), including NHANES III (1988-1994) (for previous generation) and the NHANES for 2007 to 2010 (for baby boomers), focusing on respondents who were aged 46 to 64 years during either period. "The 2 cohorts were compared with regard to health status, functional and work disability, healthy lifestyle characteristics, and presence of chronic disease."

According to findings reported in a research letter, the overall health status was lower among baby boomers with 13.2 percent reporting “excellent” health compared with 32 percent of individuals in the previous generation. Obesity was more common among baby boomers (38.7 percent obese vs. 29.4 percent) and more than half of the baby boomers reported no regular physical activity (52.2 percent vs. 17.4 percent).

Here's a chart that shows the proportion of each cohort (baby boomers and previous generation at age 46-64 years) with hypertension, hypercholesterolemia, diabetes, or obesity:


It seems that hypercholesterolemia ("high cholesterol") is the medical condition du jour of us baby boomers. According to the authors, "among baby boomers, hypercholesterolemia was more common (73.5% vs 33.8%; P .001), and medication use for hypercholesterolemia was more than 10 times greater (25.9% vs 1.5%; P .001)."

In other words, we all have high cholesterol! Of course, the line that separates "normal" from "high" cholesterol has moved significantly downward from one generation to the next, thanks in part to the push by the drug industry to sell more cholesterol-lowering drugs.

Coincidently (?), baby boomers were also more likely to have diabetes. I inserted a ? there because I recall a New York Times OpEd piece by a well-known cardiologist who said Americans are being "over-dosed" with statins to treat high cholesterol: "It is only with the more potent statins -- Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) -- particularly at higher doses, that the risk of diabetes shows up," said Dr. Topol. "The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes." I'm weening myself off statins because of a history of diabetes in my family (see "Bad News for Potent Cholesterol Drug Users, but Not Me!").

The data from this study suggests to me that too many baby boomers are taking statins to treat what they call "high cholesterol" and not getting the benefit.

“Despite their longer life expectancy over previous generations, U.S. baby boomers have higher rates of chronic disease, more disability and lower self-rated health than members of the previous generation at the same age," say the study authors. "On a positive note, baby boomers are less likely to smoke cigarettes and experience lower rates of emphysema and myocardial infarction than the previous generation."

I'm so glad I quit smoking! Now to get more serious about exercising: regular exercise was significantly less frequent (35.0% vs 49.9% exercise ) and more than half of baby boomers reported no regular physical activity (52.2% vs 17.4%).

Sunday, February 03, 2013

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.

Saturday, February 02, 2013

“SMAC” – A New Buzzword for Pharma in 2013

No, I’m not talking about the Salsa Music Appreciation Club or the Students’ Museum Advisory Council of the Utah Museum of Fine Arts. I’m talking about the intersection of Social, Mobile, Analytics, and Cloud. Although it would be a stretch to say that the pharmaceutical industry will become proficient in all FOUR of these technologies in 2013, I will go out on a limb and predict that SMAC will be popping up this year as a buzzword at many industry conferences and in vendor white papers.

I first heard about SMAC from Philippe Kirby, EUCAN MCM IT Director, MSD (Europe) Inc. during a January 16, 2013, Pharma Marketing Talk interview, where we discussed the near future of pharma digital marketing especially regarding use of the iPad, social media, and analytics in physician detailing. The following is an edited excerpt from that conversation. You can listen to the entire interview here: http://bit.ly/PMTalk187

The logo included in this post is from the SMAC LinkedIn group, which I joined to learn more about this trend. The group was established by Jithesh Sathyan, Technology Architect and Pre Sales Solution Manager, Mobility Practice at Infosys.

The current discussion topics of this group include:
  • Forrester Research: "The Future of Mobile Application Development" - Forrester urges an omni-channel approach in which software services and applications work everywhere. Netflix, which works on tablets, mobile devices, TVs, laptops and game consoles was cited as an example.
  • #SMAC becoming a priority for CIOs - CIOs need to be just as strong at strategic planning and execution as they are at technology. Many are quickly prioritizing analytics, cloud and mobile strategies to stay in step with their rapidly changing customer bases.
  • SMAC News Weekly - the latest news and numbers relating to SMAC
Most of this is too technical for me and probably most pharmaceutical marketers. However, that should not hinder the proliferation of presentations at drug industry marketing conferences that drop "SMAC" into the mix of acronyms.

Friday, February 01, 2013

Novo Nordisk's "Bait-and-Switch" Super Bowl Diabetes Marketing

Novo Nordisk's diabetes drug marketers are hitching on to the Super Bowl bandwagon. This morning, for example, I received an e-mail from Novo Nordisk's "Cornerstone4Care" program with the subject line "Delicious Big Game snacking for those with diabetes." I must have signed up for this e-mail list when I reviewed the "Diabetes and You" iBook published by Novo (see "Pharma 'eBooks': Imagining what COULD be, not what IS").

"The traditional Big Game party is usually a down-to-earth, unpretentious affair, with everyone rooting for their favorite team and enjoying snacks that are easy to serve and eat," said Novo in the e-mail message. "Of course, many of those snacks are unhealthy for everybody, let alone for the many people like my patients who live with diabetes."

The banner above this sensible message, however, piqued my interest: "Why this year's Big Game party needn't cramp your (diet) style." Which led me to believe I would find some low-carb, low-fat TRADITIONAL Super Bowl recipes if I clicked through to the site. So I did. This is the image that greeted me on the site's home screen:


Those BBQ nuggets and dip looked very tempting, so I took the "BAIT" and clicked on the little "+" sign expecting to find the anticipated lo-cal, lo-fat recipe for this traditional-looking Super Bowl dish. Instead, I found this, which I believe is called the "SWITCH" in marketing "Bait-and-Switch" scams:


Despite the photo of juicy BBQs wings on this screen, there was no recipe for that, just for fish -- and NOT the breaded, deep-fried variety as in fish and chips. I'm talking about healthy fish dishes such as Light canned tuna, salmon, Atlantic and Pacific mackerel, herring, and -- no kidding -- anchovies!

OK, fool me once, shame on you! But Novo fooled me twice! An annoying feature of this site is the pop-up when you accidentally mouse over the "Related Novo Nordisk Sites" option at the top of the screen:


All of a sudden, what was an educational, unbranded disease awareness site, is now shown to be a pitch for Novo's branded diabetes products. I'm OK with that little "switch," but I was really annoyed when I realized how difficult it was to close that pop-up and get back to the unbranded stuff without seeing ads for products. Novo is using some kind of technology -- probably Adobe Flash -- to make this pop-up have a life of its own and difficult to get rid of. Grrrrr!!!

Interestingly, the "Non-Insulin Therapy" option opens a screen about Victoza, the therapy having the famous southern chef Paula Deen as the spokesperson (see, for example, "Novo Nordisk Defends Choice of Paula Deen Over Anthony Bourdain (for example) as Celebrity Chef Spokesperson"). I was curious as to what Super Bowl recipes from Paula I would find on the Victoza site. Unfortunately, the Victoza marketing team is still focused on New Year's recipes and not Super Bowl recipes.

But I was sure that Deen's alter ego (i.e., non-Victoza spokesperson for her "Cooking with Paula" franchise; see here) would have plenty of Super Bowl recipes. Sure enough, there was no "Bait-and-Switch" here:


Paula offers more "traditional" Super Bowl recipes as in:
  • Beefy Beany Cheesy Dip
  • Garlic Shrimp Crostini
  • Sloppy Joe Meatballs
  • Tuna Kebabs with Wasabi Sauce
  • Grilled Sausage and Onion Kebabs
  • Baked Potato Skins
  • Mini Bacon Cheeseburger Sliders
  • Roasted Peppers and Onion Dip
  • Roasted Red Pepper Roll-Ups
  • Peanut Butter Mousse Cups
  • Orange Pistachio Brownies
Obviously, these recipes are not for people with diabetes, who must be satisfied with steamed fish on Sunday instead!