Saturday, February 21, 2009

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.

12 comments:

Michael said...

"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."

I do agree with the idea that Merck was fulfilling some sort of public service by making such a potentially-lifesaving product available. However, I do think that any pharmaceutical company’s true motive is to make money. In a ‘capitalist’ country like ours, it’s almost to be expected now that the big drug companies will try to sell you things you don’t need. Next thing you know, Merck will be trying to convince men that they can get cervical cancer, or that they should also be vaccinated to HPV because they could otherwise transmit the virus to women.

The biggest ‘issue’ with selling a product like the HPV vaccine is that each customer will only need it once. According to an article on medicalnewstoday.com, through a joint venture with Sanofi Pasteur MSD (a European vaccine distributor), Merck has been marketing GARDASIL to 25 European countries for last 2 years. I do think it was a wise move for them to also cover some African countries, especially when they have incredibly high fertility rates (and thus a growing youth) in comparison with the US and most European countries.

All in all, I don’t take much issue with Merck trying to blanket a wider age range than perhaps they should. I am a bit more concerned that Merck seems to be stating that HPV is THE cause of cervical cancer. I don’t think that HPV being a “factor in nearly all cases” is enough to make a claim of pure causation.

PSU PR student said...

Lauren Rothbardt

My biggest concern is with Merck’s advertising shift. Why are they shifting their marketing away from the younger end of the demographic in an effort to focus more on nineteen to twenty-six years old if the results of their studies showed that the vaccine was only effective when given prior to infection and not helpful to women who are already infected with HPV?

In an article published on MSNBC.com on Nov. 14, 1008, it states that more than 10, 000 teenage girls and young women participated in an anonymous survey on Tyrashow.com and the results show that the average age girls are losing their virginity is 15 years old. Why wouldn’t Merck focus on girls 15 and younger so they can be educated on HPV and GARDASIL before they engage in sexual encounters? The goal of Merck should be to target girls before they have sex so they can get the vaccine first and therefore use it to its’ full effectiveness

Laura said...

Merck has a monopoly on HPV vaccines with their product Gardasil. I was unaware that Merck has shifted their target audience until I read your case study. I find this to be unethical for a scientific company that is marketing a product that has killed young girls to start selling to an older demographic that has no clear benefits to gain from getting the vaccine. Corporations are always trying to make a profit, but if Merck is doing this at the expense of people’s health this will turn into a public relations problem for the company. A story on CBSnews.com from Feb. 9, 2009 titled New Worries About Gardasil Safety talk about the adverse affects the vaccine has had on young people. A private vaccine safety group compared the adverse events to the Meningitis vaccine also given to young people. Gardasil had up to 30 times higher number of events.
The Merck commercials “One less” were catchy and made people think this was going to keep them from getting cancer and that is not the case the vaccine is meant to prevent certain strains of the HPV virus linked to cervical cancer. I think this campaign was genius and Gardasil become one of Merck’s top-selling drugs, but when looked at more closely Merck might be more interested in profits than in helping young women. The campaign is misleading especially for young women and girls who are the main audience and the secondary audience their mothers.
In one of the other comments Michael said “Next thing you know, Merck will be trying to convince men that they can get cervical cancer, or that they should also be vaccinated to HPV because they could otherwise transmit the virus to women.” Merck asked federal regulators to allow the vaccine for use in males to prevent boys from spreading the virus to girls. According to the CBSnews.com article Cervical Cancer Vaccine – For Boys? Jan. 6, 2009 this was always in Merck’s long-term plan for the vaccine to increase the market for the vaccine.
Merck has caused soci-political issues with it’s vaccine drug companies face public relations crisis because their products can kill people, Tylenol and the cyanide crisis in the 80s is often an example in crisis management. Vaccines are not covered by the media in the same way as a tragic death caused by a drug poisoning a person. Vaccines always have complications and adverse reactions just listen to a Claritin commercial or any other drug commercial. Some are minor, but Gardisal is still new and Merck’s aggressive marketing tactics might cause them problems in the future for now though the controversy over the vaccine gives them free exposure.

PSU PR student said...
This comment has been removed by the author.
Melanie Loomis said...

I also don't blame Merck for targeting to a larger audience than it maybe should be because of the scientific debate of the effectiveness of the vaccine. If a business wants to stay in business, targeting to a broader segment in this case is necessary.
Statistically, it may not help every single person in the older age range but if it even saves one life- then Merck has done its job. Merck never claimed to be miracle workers. They are simply doing thier job and selling pharmacutical drugs that will enhance peoples' quality of life. In a capitalist market, the consumer has to take some responsibilty before investing in a vaccine. If not, then Merck has every right to make money (and perhaps save one's life) of someone who doesn't feel like doing the research prior to putting something in their body.



My question to the presenters is whether this marketing strategy did infact make up for the decline in sales in July/August of 2008.

Olivia said...

Merck clearly has its focus on the profit it can gain over the self-interests of its drug consumers. This profit-seeking motive explains their reasoning for starting to target older women who would not benefit from the drug. According to the CBSNews article “New Worries About Gardasil Safety,” there have been 29 deaths reported that are linked to the Gardasil vaccine. I was actually surprised by this because of the positive commercials and “talk” about the Gardasil shots. I feel as though there has been a lot more positive coverage of the Gardasil drug compared to the negative events surrounding it. The CBSNews article also recognized how Merck is now trying to have Gardasil approved for males. Again, this will give Merck another avenue for profit. While, I think that Merck is now looking for ways to increase profit with Gardasil, initially their idea to create Gardasil reflects their desire to help tackle this increasing health problem. Therefore I will give them credit for creating the vaccine, but I think their present motives are leaning more towards profit over public service.

In looking at Gardasil’s “One less” campaign, I applaud them. I think the campaign was very successful and convincing of the drug’s abilities to “cure” you from cervical cancer. While the campaign could be considered misleading because of its portrayal of Gardasil as a complete cure from cervical cancer, it was still effective. I have not received the vaccine, but to be honest, after seeing those commercials, it definitely made me want to learn more about the vaccine. After learning more about the company and the vaccine from the case study and the article, it made me realize how affective their campaign was because up to this point I have had only positive feelings regarding the vaccine. Looking at Merck and Gardasil from an advertising/pr view I think they did a fantastic job of marketing their product and shaping a positive image for it. However, ethically and scientifically they need to reevaluate their initial reasons for creating the vaccine and its audiences and acknowledge the effects and fatality stories that relate to the drug. While the company stands by its statement that Gardasil’s benefits outweigh its risks, it needs to focus on how serious the risk might be and communicate this to its publics.

allison said...

The health care side of public relations is one which must use the highest ethical standards. Because GARDASIL is marketed as the “cervical cancer vaccine,” and this has the possibility of tricking young women into thinking that they are immune from cervical cancer, it makes the company appear to be deceptive. All corporations need to make a profit but when research states that the vaccine is not effective in older women it should not be marketed to that population.
I have seen many of the GARDASIL commercials and think that they have done a great job at making their messages "sticky." The simplicity of their message makes it easy to remember and the fact that they exploit the mother-daughter relationship appeals to my emotions as a member of their target audience. However, Merck must pay close attention to medical studies about its products and be sure to keep up to date on the research to make sure they are not using unethical marketing techniques.

Jess said...

While the development of the GARDASIL vaccine was a great service to young women, the marketing of it is not. There is a very fine line in terms of ethics with pharmaceutical companies, and Merck may cross it at times with this campaign. Yes, the "one less" message is sticky. However, Merck uses that to exploit older women to get the vaccine when it may not even benefit them. The campaign can be misleading to consumers, as the vaccine is marketed as THE cervical cancer prevention. It gives rise to the idea that if a woman gets the vaccine, then she will not get cervical cancer. Merck hasn't done anything to dispel this myth.

Melanie Loomis said...
This comment has been removed by the author.
PSU PR Student said...

(7 posting recorded at 10 a.m. 2/23/09. All others -20 points) Nichols

Anonymous said...

This text is invaluable. Where can I find out more?
My site: free teen porn

Anonymous said...

I am regular visitor, how are you everybody?

This paragraph posted at this site is actually fastidious.
Also visit my site - free sex