GARDASIL: The Selling of a Drug and a Disease

Comm473: Kelly McNulty and Christiana Pluta

Situational Analysis:

Merck and Co. Inc, established in the United States in 1891, describes themselves as “a global research-driven pharmaceutical company dedicated to putting patients first (http://www.merck.com).”According to their mission statement, they are committed to the highest standards of ethics and integrity and commit their research to improving human and animal health and the quality of life. They also discover, develop, market and manufacture vaccines and medicines to address unmet medical needs and devote efforts to increase people’s access to medicines. They were the first company to develop a vaccine for cervical cancer in the summer of 2006. Cervical cancer is defined by the National Cancer Institute as “cancer that forms in tissues of the cervix, the organ connecting the uterus and vagina. Cervical cancer is usually a slow-growing cancer that may not have symptoms but can be found with regular Pap tests (http://www.cancer.gov/cancertopics/types/cervical).” But according to the National Cervical Cancer Coalition (NCCC), about 10,000 women in the United States are diagnosed with cervical cancer each year and about 3,700 women die each year from the disease. In the majority of developing countries, cervical cancer remains the number-one cause of cancer-related deaths among women. The virus HPV, or Human Papillomavirus, is a factor in the development in nearly all cases of cervical cancer. More than 100 types of HPV are known to exist, with some being low–risk types, but even those may cause cancer (NCCC). The vaccine developed by Merck called GARDASIL prevents HPV types 16 and 18 that relate to 70% of cervical cancer cases, and types 6 and 11 that cause genital warts. GARDASIL was approved for girls and young women ages nine to twenty-six.

Research Conducted: According to the Food and Drug Administration’s (FDA) Web site on June 8, 2006, a total of six studies were conducted to show how well GARDASIL worked in women. Four of the studies were conducted with women between the ages of sixteen and twenty-six, and two were conducted with girls ages nine to fifteen. In the older group, 21,000 women were either given the vaccine or a placebo. The results showed that GARDASIL was almost one hundred percent effective in preventing “precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed,” in women who had not already been infected. The prevention of those lesions was believed to be highly likely to result in the prevention of those cancers, although the study period was not long enough for cervical cancer to develop. The results also showed the vaccine was only effective when given prior to an infection, and not helpful to women already infected with HPV types included in the vaccine. In the two studies given to girls, ages nine to fifteen, their immune response was equal to that found in the sixteen to twenty-six year olds, indicating that the vaccines effects should be similar. The vaccines safety was evaluated in approximately 11,000 subjects. Most of the adverse reactions experienced were pain and tenderness at the injection site. Also according to the Web site, the manufacturer (Merck) agreed to conduct several studies after the license was approved in other to evaluate the general safety of the vaccine and its long-term effectiveness. Merck also agreed to monitor the pregnancy outcomes of women who received the vaccine while not knowing they were pregnant, and to evaluate the safety and effectiveness of GARDASIL in males (FDA).

Execution and Evaluation:

The GARDASIL vaccine was approved by the FDA in June 2006, but prior to unveiling its national “One Less” advertising campaign for GARDASIL, Merck funded other campaigns which included the Make the Connection campaign in 2005. This campaign centered around the Make the Connection bead, a part of a make-it-yourself bracelet kit that would help raise cervical cancer awareness. This eventually evolved into the Make the Commitment Fund, where women were challenged to sign a pledge on the Web site that stated; I, (name) am making the commitment to talk with my healthcare professional in January about ways that I can prevent cervical cancer, including getting regular cervical cancer screenings (http://www.bio-medicine.org/medicine-news).” Giving women the opportunity to not only sign but read and understand the pledge on the Make the Connection Web site ensured that doctors would be receiving questions about cervical cancer, ones they could answer by bringing up GARDASIL once it was available. After these “pre-campaign” campaigns were completed, the “One Less” campaign began. The television, print and online advertisements featured the slogan “One Less,” with girls and young women saying they wanted to be one less woman battling cervical cancer. According to Bev Lybrand, vice president and general manager of the Merck Vaccine Division, "The full public health benefit of reducing the burden of cervical cancer and HPV disease may be achieved through broad public awareness and vaccination with GARDASIL, which is the driving force behind One Less (http://www.medicalnewstoday.com).” The campaign focused on a positive message to encourage women and inform them about GARDASIL and the risks of cervical cancer. While empowering them to become “One Less,” the campaign not only encouraged young women to get the vaccine, but also to continue to see their doctor for regular health screenings (http://www.youtube.com/watch?v=hJ8x3KR75fA). While GARDASIL continues to be promoted through this campaign, another brand of commercials are also being played. In these “I Chose” commercials, both adult women and young girls are shown saying things like “I chose to get my daughter vaccinated because I want her to be one less woman affected by cervical cancer” and “I chose to get vaccinated after my doctor told me GARDASIL does more than help prevent cervical cancer(http://www.youtube.com/watch?v=gd4ypCXusrI).” Both the “One Less” campaign and the “I Chose” commercials play into the vaccines target market, which is both young women and their mothers. By using slogans of empowerment, Merck is able to reach the target market they want to receive the vaccine. By having mothers speak in the “I Chose” commercials, it plays into mothers instincts to protect their children, as well as gives a voice for the younger girls who need a parent’s consent in order to be vaccinated.

Although Merck is a credible pharmaceutical company, they are the only company to have this vaccine, and because it is the only vaccine that prevents any strain of HPV that causes cervical cancer it gives Merck an advantage on both fronts. They are fulfilling their social responsibility by making GARDASIL available in order to help combat cervical cancer, but since they are also the only company with a vaccine of this type, they are able to make a lot of money from it. GARDASIL is being marketed as the “cervical cancer vaccine,” and young women who receive it may not know there is still a chance of them getting cervical cancer. The vaccine was targeted to prevent HPV, a cause of cervical cancer, but not the cancer itself. This concept may be confusing to young women, who may not realize that even with the vaccine they can still get cervical cancer. Also, according to financial site Bloomberg.com, Merck is now targeting GARDASIL to women who may not benefit from the vaccine in order to compensate for a decline in sales in July and August 2008. Although women ages nine to twenty-six were always the target market, Merck has shifted its marketing away from the younger end of the demographic in order to focus on nineteen to twenty-six year olds, the part of the demographic they insist will benefit from the vaccine although they are having difficulty trying to get this age group to receive the shot. Researchers at Harvard University concluded in an August 2008 study that the vaccine is not effective in the older age group. Those findings correlate with the recommendations of the American Cancer Society (http://www.forums.pharma-mkting.com/showthread.php?p=8547). As more girls get the shot, the market for those who need it declines, which is why Merck is trying to market towards another demographic, but marketing GARDASIL to women who will not benefit from it in order to turn a profit will not help their campaign. According to a study done by researchers at Harvard and published in August 2008 by The New England Journal of Medicine, giving GARDASIL to women through their mid-twenties might not be worth the price (http://content.nejm.org/cgi/content/full/359/8/821). The three-dose vaccine costs approximately $360, but according to the Department of Health and Human Services Centers for Disease Control and Prevention, it is cost-effective for women ages nine to twenty-six, including women who are sexually active, because few of those women are actually infected with the four HPV types the vaccine covers. As a result, they would still be protected by getting the vaccine (http://www.cdc.gov/std/Hpv/STDFact-HPV-vaccine.htm).

Professional Interview:

For our case study, GARDASIL: The selling of a Drug and a Disease, we interviewed Michael F. Doble, accredited in public relations (APR), a certified functional continuity professional (CFCP), and the director of strategic communications for the Raytheon Company in Arlington, Va. Raytheon describes their company as “a technology and innovation leader specializing in defense, homeland security and other government markets throughout the world (http://www.raytheon.com/ourcompany/).” Although Mr. Doble’s expertise are not in pharmaceuticals and he is not overly familiar with Merck’s campaign for GARDASIL, he was willing to do some of his own research about it, in order to answer any questions we may have had. We asked for some of his thoughts about how he believed the campaign was handled from a public relations standpoint. As stated,

“Here are a few impressions after reading a little on this: While the campaign was very good at illuminating the issue, I believe that Merck went beyond what science told them by targeting older women for the vaccine. To the uninitiated they appeared greedy and more concerned about sales than science: a PR blunder that will haunt them. I've been around long enough to know that you can find an "scientific expert" to support almost any point of view, there are clearly enough credible experts arrayed against extending the vaccinations to older women to make it a net minus instead of a net plus. Also, the whole "make vaccination mandatory" lobbying effort looked like a thinly veiled pitch for additional business (Doble).”

After listening Mr. Doble’s opinions about the issue, it was apparent that although he believed the campaign illustrated the risk of cervical cancer in young women, Merck may have surpassed justifiable limits. Furthermore, by trying to target older women with the vaccine, Merck gave the impression of being more concerned with sales than with the social well-being of their customers. The most interesting opinion in Mr. Doble’s interview was how he believed there were enough “credible experts” to go against Merck’s idea of giving older women vaccinations. While this might be the opposite of what Merck desires, they may have to move away from their goal of giving GARDASIL vaccines to older women if there are, in fact, enough experts against it.

Overall, Mr. Doble was able to give us his perspective on Merck’s GARDASIL campaign and while he was not involved in the campaign or with Merck, his public relations expertise allowed him to give an insightful analysis of the campaign Merck implemented.