Pharma Marketing News Vol. 15, No. 4 - Pharma Marketing Network

Pharma Marketing News

Vol. 15, No. 4: September 2016

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here seems to be an epidemic of fear among the U.S. electorate. Pharma marketers may be tapping into that fear by creating dark and ominous “disease awareness” ads, the goal of which is to instill fear in the viewing public and motivate them to see the doctor. I was quoted in a recent Ad Age story (see http://sco.lt/8kIIhF) about the recent spate of scary drug ads seen on TV and in print. The title of the article—“Halloween Already? Big Pharma Marketers Try Terror Tactics to Scare Up Sales”—was bit over the top but, hey, that’s how you sell content. The article quoted me as saying “a trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine.” Aka “Unbranded” Ads As you may already know, according to the FDA, disease awareness (aka “unbranded”) ads are communications “disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.” (see http://bit.ly/2buY1DD).

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Some marketers will only engage in disease awareness marketing if their product is the only one on the market approved for the treatment of the disease. That’s because a common goal of all disease awareness ads is to motivate consumers to take action such as visiting the sponsor’s website or visiting the doctor and asking about an available treatment—hopefully one that’s marketed by the sponsor. One downside is that disease awareness campaigns may help improve the sales of competing products as well; i.e., a rising tide of consumer interest floats all products’ boats! No Risk, No Foul? When unbranded ads mention the benefits of “drug treatments,” should they also mention risks of these treatments and/or life-style changes like branded ads are required to do? Some critics say yes, but the drug industry consensus is that the major statement of risks required in TV ads is often too long and “may result in… therapeutic noncompliance due to fear of side effects.’ “Omission” or “minimization” of risk information is by far the most commonly-cited violation cited by FDA with regard to branded drug ads. This is evident from data compiled from FDA warning letters by EyeOnFDA (see Figure 1).

FDA believes that disease awareness communications can provide important health information to consumers and health care practitioners, and can encourage consumers to seek, and health care practitioners to provide, appropriate treatment. This is particularly important for under-diagnosed, undertreated health conditions, such as depression, hyperlipidemia, hypertension, osteoporosis, and diabetes. Traditional Disease Awareness Marketing Traditionally, pharma marketers have opted to run disease awareness campaigns if their products have serious side effects and/or black box warnings. That’s because, unlike branded drug advertising, disease awareness communications are not subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act and FDA regulations; specifically, the FDA does not require these ads to mention any treatment side effects, except when it does (see page 2). Disease awareness ads have also been favored by companies that expect to market a drug for the disease, especially if the company is new to the therapeutic area. Physicians may be the preferred target audience, especially during the pre-market phase of drug development. © 2016 Pharma Marketing Network. All rights reserved. Pharma Marketing News

Figure 1. EyeOnFDA Analysis of Violations Cited in FDA Letters (2004 through 2013). Source: http://bit.ly/pmn140103p

Other violations cited in FDA letters include: • Superiority claims • Overstatement of efficacy • Unsubstantiated claim • Broadening of indication • Promotion of an unapproved use • Promotion of an unapproved compound Continues…

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As mentioned above, some academics and drug advertising critics believe that disease awareness ads that mention benefits of treatments, also should mention risks. Dr. Aaron Kesselheim, Assistant Professor of Medicine, Brigham and Women's Hospital, for example, recommended this approach in an interview with Alan Schwarz, a National Correspondent who wrote a scathing Exposé of ADHD Drug Marketing in the New York Times. Specifically, Dr. Kesselheim cited an ADHD disease awareness video as a case study. That video cited American Academy pediatric guidelines that recommends “stimulant medications” to treat ADHD and also mentioned that these medications were safe. No mention, however, was made of the side effects of such medications. Listen to a snippet of that conversation here: http://bit.ly/1gA1jQk Stealthy Product Promotions Perhaps many pharma marketers don’t realize that the FDA is on record for stating it will treat certain disease awareness ads as “labeling” and subject to its regulation. If, for example, FDA determines that “a supposed disease awareness communication impliedly identifies a particular drug or device, which may be the case when a communication relates to a drug or device that is the only drug or device in its diagnostic or therapeutic class or the only product manufactured by a company, then the agency may treat the communication as labeling or advertising under the [federal food & drug] act.” In fact, in 2010, FDA issued a warning letter to GSK about a medical journal print ad that promoted a “NEW Treatment Option for Refractory Chronic Lymphocytic Leukemia (CLL)” without mentioning the name of that option or its potential side effects. In the letter, FDA said: “The characteristics of the product promoted in the ad can only describe Arzerra. Not only is Arzerra the only recently approved drug marketed by GSK for © 2016 Pharma Marketing Network. All rights reserved. Pharma Marketing News

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CLL, but no other product approved for the treatment of CLL has an indication that is limited to this specific population… Consequently, this presentation is a product-specific prescription drug ad for Arzerra” and is subject to disclosure of common adverse reactions (read “GSK Awareness Ad for Arzerra a ‘Stealth Product Promotion,’ Says FDA”; http://sco.lt/6mjvXd). Going Dark & Scary As mentioned in the beginning of this article, lately many disease awareness ads have taken a distinctly dark approach and, in some cases, placed blame on parents and grandparents. An example of the latter approach is GSK’s current “Big Bad Cough” multimedia campaign that focuses on a grandma putting her baby grandchild in danger of catching whooping cough from her: “Understand the Danger Your New Grandchild Faces.” See Figure 2, below, for a copy of a print ad that appeared in a recent Parade magazine.

Figure 2. “Grandma, What a Big Whooping Cough You Have.”

According to GSK: “Adults have historically low vaccination rates. For Tdap, the combined diphtheria, tetanus and pertussis vaccine for grownups, only 17% of adults over age 19 are up-to-date, according to recent CDC [Centers for Disease Control] data. GSK said grandparent vaccination rates are even lower, coming in at below 10%.” Perhaps it’s OK to portray new grandmas as wolves in grannie clothes, but what about wolves? As one Continues… 2



commenter to Pharma Marketing Blog noted: “This campaign … needlessly vilifies wolves. It is totally depressing for people who have worked for years to bring this endangered species back to ecological health to find the same stupid and anti-educational stereotypes being employed again. They really couldn't come up with some viable contemporary campaign to educate about pertussis without antiscientific depiction of wildlife? Makes me sick!” The Mom & Dad Blame Game Fear tactics seem to be the choice marketing strategy for many vaccines. Another example—this time from Merck—is an HPV awareness TV campaign that puts the blame on parents for not vaccinating their children who go on in later life to develop cancer! Back in 2008, when I thought the vaccine business would not be profitable for pharma (silly me! Read “Vaccines Are Path to Better Revenue Growth for Some Pharma Companies”; page 4), I lauded Merck’s Gardasil DTC campaign. “It was effective for me,” I said. “And I am sure that word of mouth will spread quickly. For me, the launch of Gardasil sent the message that Merck is a leader in the area of disease prevention, which puts people first” (read “Merck on a Roll”; http://bit.ly/2cimye9). These days, when Gardasil sales are lower than expected and with competing products on the market, Merck's HPV awareness ads have become darker and, as mentioned above, put the blame on parents who don’t get their children vaccinated (read “Merck Ad Blames Parents & Asks: ‘Mom, Dad, Did You Know’”; http://sco.lt/4wtOs5). A Merck spokeswoman said the awareness campaign is needed because in its own survey of 858 parents “about 85% were familiar with HPV, but only about 50% knew about the link between the virus and cancer” (see http://sco.lt/4wtOs5). Gambling in the Social Media Age Putting pressure on moms and dads may be a smart move for Merck, especially when pediatricians are reporting that more parents are refusing vaccination for their kids primarily because they believe vaccines are not necessary. And Merck can afford to “float all boats” viz-a-viz HPV vaccine sales because it is the market leader and will benefit the most from HPV disease awareness ads like this.

© 2016 Pharma Marketing Network. All rights reserved. Pharma Marketing News

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Take a Lesson from Mylan But when you blame the caregiver—especially moms—you are opening yourself up to some powerful backlash via social media. “I respect parents who get mad about the [ads], but they should take that pissed-off feeling and ask their doctors about vaccinating their children,” said the chairman of the American Cancer Society’s HPV Vaccination Roundtable in response to the social media backlash against the “Mom, Dad, Did You Know” campaign. It has been said that moms “harnessed the power of social media” to challenge Mylan after it increased the price of life-saving EpiPens 600% and aired a “fear-mongering ‘Face Your Risk’ disease awareness ad. At first, response via social media was positive but then ‘soured’ as Mylan was accused of ‘price gouging’ by moms” (read, for example, “How Parents Harnessed the Power of Social Media to Challenge EpiPen Prices”; http://nyti.ms/2c4apcb and “Big Pharma just poked the wrong group: Moms”; http://bit.ly/2bLEAkp).

Figure 3. Images from Mylan’s “Face Your Risk” Anaphylaxis Shock Ad. The women on the left covered with red blotches (not from “cupping”) is suffering from anaphylaxis shock after eating cookies made with peanut butter by the woman on the right. Text added to this montage is not part of the ad. The woman on the right is actually saying “Oh, no, I forgot! I’m so sorry!”

Even Branded Vaccine Ads Are Dark When a STATnews reporter asked me what’s behind ominous unbranded “disease awareness” ads these days, I opined that if you’re a drug maker, “you don’t want to attach a dark image to the brand—so you’re attaching this dark imagery to a medical condition instead,” which leaves room for a branded ad that shows “the bright side: that there’s this product that can save the day” (Read “#Pharma ‘Disease Awareness’ Ads: Are They ‘Stealthy’ Fear Mongering Set Pieces?”; http://sco.lt/7WBvg9). That “conventional wisdom” or “rule”—if it is one— obviously does NOT apply to many ads for vaccines, especially lately. Take, for example, the TV ad for Trumenba - Pfizer's Meningitis B vaccine (see Figure 4, page 4). Continues… 3



Vaccines Are Path to Better Revenue Growth for Some Pharma Companies (Curated from http://bit.ly/2bW4jvq)

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Meningitis B. The source of the infection is traced back to a party where the teenager shared food, drinks and a kiss with friends. Trumenba offers a vaccine to prevent future spread of the disease.” Bummer! Teens can’t even enjoy an innocent kiss without fearing for their lives! This is obviously a “dark” and scary ad aimed at the parents of teens for whom this vaccine is indicated (up to age 25). Is It Motivational? My comments quoted in the Ad Age piece mentioned at the beginning of this article hit a nerve with Bob Ehrlich, Chairman of DTC Perspectives. In a DTC in Perspective Blog post titled “Ad Age Article Cites Rx Fear Mongering,” Ehrlich wrote:

The revenue growth opportunity in vaccines looks far more promising when compared to the overall market for pharmaceuticals. Revenues earned by vaccines manufacturers worldwide reached $27.6 billion in 2015 according to Kalorama Information, up 11% from $24.7 billion in 2014, as sales in all segments expanded. This is, by Kalorama’s estimate, at least five to ten times the revenue growth rate of the overall pharmaceutical market in recent years. The world vaccines market is predicted to increase at a compound annual rate of 7.6% during 2013–2022, reaching $45.1 billion in 2022 as new product introductions continue and usage of current products expands further. The world vaccines market is dominated by four major competitors: Sanofi Pasteur, GlaxoSmithKline, Merck & Co., and Pfizer. Pfizer and Merck hold 45% of the market. As the market leader in 2015, Pfizer’s vaccine sales exceeded $6.4 billion on strong growth of its Prevnar family, giving the company 23.3% of the market. Merck had $5.9 billion iin sales.

Figure 4. Scenes from a Recent Trumenba TV Ad

As described by iSpot.tv (http://bit.ly/2chJtpZ) the Trumenba ad “follows the series of events that lead up to this young man being in a hospital with © 2016 Pharma Marketing Network. All rights reserved. Pharma Marketing News

“Drug ads are meant to motivate action. Showing what can happen when not vaccinated is not fear mongering. I have been reviewing DTC ads for over 20 years and there is no new trend to using scare tactics.” Good to know that scare tactics in pharma ads have been around for over 20 years! Mr. Ehrlich had some other things to say in defense of scary drug ads. “A scary disease caused by failure to get a vaccine deserves a sober assessment of the situation,” said Ehrlich. “Showing a person dealing with a life threatening allergy shows reality. Meningitis can kill, and HPV can cause cancer. Advertising deadly consequences is meant to be scary. The ads referred to as cheerful were those for conditions that were bothersome, but not deadly, such as allergy ads.” In the past, Ehrlich suggested that side effect information in DTC ads scare consumers and that “we need to be judicious how we approach patients with side effect information. I believe we need to do a better job giving patients the real odds of something happening to them” (read “Scare Balance or Scare Tactics?”; http://bit.ly/1eIdoMJ). The same could be said for the odds of becoming a victim of the scary diseases mentioned in many DTC ads. In any case, some ads are unnecessarily scary. Take, for example, GSK’s whooping cough, disease awareness ad, which I mentioned above (see page 2). The premise of this ad is that grand-parents can transmit whooping cough to their newborn grandchildren because they—the grand-parents—haven’t been vaccinated. It just so happens that GSK has a whooping cough vaccine approved ONLY for adults 65 years of age and older. Thus, GSK must market only for that use even though the CDC says that Continues… 4



expectant mothers can provide “the most protection to your baby by getting the whooping cough vaccine during pregnancy and making sure your baby gets her whooping cough vaccines on time.” In addition, a study of health care workers—e.g., nurses handling newborn infants—unrecognized pertussis infections (diagnosed by serology) were common, with an average annual rate of infection of 33%. Perhaps GSK should scare healthcare workers into asking THEIR doctor about vaccination. Fear Sells More Than Logic Santosh Upadhyay, Former Category Manager Marketing and Business Development, at Novartis Vaccines, made this comment to my post on LinkedIn (http://bit.ly/2cern3z): “These type of ads are done when the advertiser doesn't feel that the public is buying the rational behind the use of the vaccine or for that matter any other life saving drug or medicines. It is just like when a discussion happens, you raise your voice rather than strengthening your argument. This makes the person raising his voice feel he is in command but invariably loosing the logic behind why he is saying that. “One would say it is better to raise awareness among people through other patient outreach programs rather then petrifying them by fear. However the truth remains that, historically, fear, particularly in

© 2016 Pharma Marketing Network. All rights reserved. Pharma Marketing News

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vaccines, sells more than logic. It is not that there aren't any creative solutions to propagate vaccines but it is just that people want to follow the beaten path. In psychology the biggest motivator is avoidance of pain much ahead of seeking pleasure and that's what advertisers encash upon - the strategy, that people would rather be motivated to avoid the fear of loosing someone near and dear, than the pleasure of keeping the people around healthy. Though the second strategy sounds more reasonable and is also scientific, the former gets precedence and thus you see the ads you see today.” Conclusion Whether or not pandering to people’s fears is a new trend in pharmaceutical marketing to consumers is debatable. There is a fine line, however, between alerting people to a danger and “fear mongering” in order to sell more product. Marketers tend to tap into emotions and fear is one of the strongest of human emotions. But what we all need these days is less fear and more EDUCATION. At least let’s make sure that consumers understand the risks without being scared to death! For a more complete catalog of dark and scary unbranded and branded drug ads access the presentation below on Slideshare: http://bit.ly/ScaryPharmaAds Pharma Marketing News

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