Wednesday, October 29, 2008

HPV case study

HPV Campaign: “One Less” To Battle Cervical Cancer
Situation Analysis

In the 1950’s, cervical cancer was the leading cause of deaths from cancer among women. Although advancements in screening and pap tests have helped 70% of women who would have died from cervical cancer, approximately 10,000 women in the US are diagnosed with cervical cancer every year and approximately 3,500 women die from it. Cervical cancer is especially a problem in developing countries where about 200,000 women die each year. A virus called the Human Papillomavirus, or HPV, is the cause for almost all cases of cervical cancer. The most common cancer causing types of the virus are 16 and 18 which is responsible for causing 70% of all cervical cancer. Both women and men become infected with HPV through sexual intercourse and sexual contact and may never know if they have it because there are no signs or symptoms of HPV. Most women will be exposed to HPV in their lifetime and in most cases the virus goes away by itself, but in some it can eventually turn into cervical cancer. Early detection and prevention of the HPV virus from turning cells in the cervix into cancer cells is the only way to prevent cervical cancer.
Merck &Co., Inc., a global research pharmaceutical company, developed the world’s first cervical cancer vaccine in 2006 called Gardasil. The vaccine prevents HPV types 16, 18 that relate to 70% of cervical cancer cases, and types 6 and 11 that cause genital warts. The vaccine was FDA approved on June 8, 2006 for woman ages 9 to 26. By November 2006 Merck announced its national print, television and online advertising for the Gardasil campaign. Along with Merck’s educational efforts about cervical cancer and HPV, the campaign called One Less encourages females who are eligible for the vaccine to start the three shot series and see a doctor regularly for screenings and check-ups. The one less campaign is designed to inform and empower girls and women to become “one less” person to develop cervical cancer. Merck is committed to the public awareness of HPV and education of the disease through the Tell Someone and Connection multi-lingual disease awareness programs to broaden the education of the HPV virus and its connection to cervical cancer. Merck also works towards making Gardasil available in developing countries where cervical cancer is a most important woman’s health issue killing about 200,000 women each year. Around the world there are at least 500,000 new cases that are diagnosed annually and 80% of them are in developing countries.
Merck made attempts in making the series of Gardasil shots mandatory for young women and there were considerations for these requirements in some states such as, Texas and Minnesota (Childs, 1). Mandates that Merck was attempting to instill in some states was rejected because it was thought, especially by parents, that since Gardasil is aimed at girls as young as nine years old, it would encourage promiscuity. Since HPV is a sexually transmitted virus, it could give young girls a wrong impression that they are protected from diseases if they are sexually active, which is not the image Merck wanted to give to young girls about Gardasil. In an article titled, “Political Intrigue in Merck's HPV Vaccine Push” from 2007, Mary Elizabeth Blake the senior director of public affairs for the Merck vaccine division, made a response to this through e mail. She stated, "We … do not want any misperception about Merck's role to distract from the ultimate goal of fighting cervical cancer, so Merck has re-evaluated its approach at the state level and we will not lobby for school requirements for Gardasil," (Childs, 1). Merck retracted its efforts in making mandatory vaccinations for young girls to go through in some states because it distracted from the original effort to educate women of various ages of the HPV virus and how it can form into cervical cancer. Merck realized that they may have pushed too hard too fast making mandates for the vaccine because the public needed time to realize that the vaccine worked before they can make it mandatory for young girls, and potentially hurt them. Though the vaccine is a positive effort for all girls to participate in, a new product such as this cannot be pushed onto them before they feel safe. Merck made a very good decision to pull away from its push to make the vaccine mandatory and recognizing that although they know the vaccine will help in reducing the number of deaths from cervical cancer, they needed the public to believe this on their own and continue their efforts in educating the public about HPV before they can issue mandates on the vaccine.


Research
In researching which types of the HPV virus the Gardasil vaccine would work to prevent, Merck ran a series of tests using their target audience. An article from 2007 titled, “HUMAN PAPILLOMAVIRUS; Research from Merck & Company, Inc., Department of Health has provided new information about human papillomavirus”, stated that Merck’s study populations consisted of women from the United States, ages 16-23, having zero to five lifetime sexual partners, never having been pregnant, and never before have had an abnormal pap. test. These women underwent DNA tests every six months for a 48 month duration that tested HPV types 6, 11, 16, and 18. After two clean swab samples that were negative to any types of HPV infections, the duration of swab samples were tested for exposure to the four types of HPV Gardasil prevents. In conclusion to the researchers study, the tests showed that HPV 16 and 18 durations were twice as much as HPV types 6 and 11. The statistic that HPV types 16 and 18 account for 70 percent of all cervical cancer cases was proved to be true here in the study because it showed up twice as much as the other two types of HPV viruses that was tested.
With studies conducted by Merck that compared women, ages 24 to 45, who have had the vaccine to prevent HPV types 16, 18.6, and 11 to women who were given placebos instead of the vaccine. Results showed that Gardasil prevented, “91 percent of cases of persistent infection, low-grade cervical abnormalities, and pre-cancers, and external genital lesions caused by HPV types 6, 11, 16 and 18 compared with placebo in women aged 24 through 45” (Cancer Vaccines, 1756). This study in 2007 helped Merck provide information to present to the FDA for approval in expanding the Gardasil vaccine to women up to age 45. The results from these various tests indicate that women have potential to be infected with the HPV virus throughout their lifetime and the vaccine can help prevent these threats at various ages. Referenced in the same article titled, “CANCER VACCINES; New Data Presented on GARDASIL(R), Merck's Cervical Cancer Vaccine, in Women Through Age 45”, from 2007, is data from the International Multi-Center study, which is designed to examine Gardasil and involved more than 3,800 women in its study. It found that women who did not have any HPV infections remained that way throughout the series of vaccines and at the end of the third vaccine. It showed that there were 41 cases of infection in the placebo group and only 4 cases in the group who received the vaccine having a 91 percent reduction, and Gardasil also reduced abnormal Pap tests showing HPV types 16 and 18 by 94 percent. During these studies, the only undesirable experiences were those at the injection site consisting of, “erythema, pain, pruritus, swelling and warmth” (Cancer Vaccines, 1756), which were higher in the vaccine group than the placebo group.
Merck researched the vaccine before FDA approval in 2006 and continued to expand its research so the vaccine could be used to its full capability in many age groups from young girls to women. Currently, there has been some research done to expand the vaccine to men as well as women. Because the HPV virus is sexually transmitted, the vaccine given to men can further help to prevent the spread of the virus even before it is presented in women. An article titled, “Gardasil vaccine now offered to boys, young men”, states that by 2009 boys will have the option to also take Gardasil to further prevent cervical cancer. Arguments for the issue of the vaccine for boys are that not only will it help prevent cervical cancer, but will also prevent genital warts for boys. Some of the same arguments against issuing this vaccine for boys is the same issues for young girls. The same risk of increased promiscuity can be seen here, now boys will have the reassurance that they are safe from spreading genital warts and HPV to girls through sexual intercourse. It could make the desire to have safe sex more desirable at a younger age. Even though the use of condoms helps prevent other sexually transmitted disease, HPV can be transferred from skin to skin contact and condoms do not cover the entire genital area. If Merck would like to issue the vaccine eventually for boys, they will have to go through the same precautions as they did when issuing it to young girls and have a tactic that will talk to parents of boys as well who may be unfavorable in submitting their sons to a vaccine meant to prevent cervical cancer.




Planning
Before Gardasil was approved by the FDA in 2006, Merck had the “Tell Someone” campaign already in action. The “Tell Someone” campaign focused on giving information about HPV and cervical cancer to women and stressing the importance of passing this information on to other women. Merck was able to stress the dangers of this virus and the importance of finding a way to prevent this virus from spreading to others. It was a good introduction for the need of the Gardasil vaccine and an excellent way building up anticipating a cure for the virus that women have now already learned was an important and ongoing problem for young girls and women. The “Tell Someone” campaign focused more on informing mothers and having them tell their daughters about HPV and the dangers of it turning into cervical cancer. The types of commercials that showed mothers with their daughters were often shown after shows that reflected families or mother daughter relationships such as “Gilmore Girls”. Focusing on parents to tell their children about these dangers kept the campaign on an informational level and did not pertain to the vaccine yet. This type of planning allowed Merck to focus on developing the vaccine and getting it approved while parents learned of something that was a danger to their children while waiting for a breakthrough that will help them, beyond just the efforts of just having information about the disease.
When Gardasil became approved by the FDA in 2006, by November of that year Merck launched its “One Less” campaign. In an article titled, “The Gardasil HPV Vaccine: Not the Shot in the Arm Merck Hoped for” from the PR watch. Org website, Edelman Public Relations Company, the largest independently owned PR company with 46 offices and 50 affiliates around the world, implemented the “One Less” campaign. This campaign took off of the informational campaign ideas of the “Tell Someone” campaign, but now there was something that women could do about the risk of getting an HPV infection and that was to get a three series shot of the Gardasil vaccine. The “One Less” campaign urges girls to become one less statistic of cervical cancer by taking the precaution of having the Gardasil vaccine to become one less person to struggle through cervical cancer. The commercials from this campaign featured a variety of girls from skateboarders to dancers who wanted to become “One Less” cervical cancer victim. The commercials had some information about the HPV virus and how it can later lead to cervical cancer, and encouraged girls to find out more information by consulting their doctor.
Merck then followed some of the same tactics from the “Tell Someone” campaign when they slightly changed the “One Less” tactic to the “I Chose” campaign. This issued some images of mothers who have already implemented the vaccine to their daughters saying, “I chose to get my daughter vaccinated”, and also confessions from girls saying, “I chose to get vaccinated after my doctor told me Gardasil does more than help prevent cervical cancer." Merck’s advertising plan followed the path that women were taking while Gardasil had been a product for some time. It started with providing information, then when the vaccine was approved it showed women having the desire to become one less person to fight cervical cancer, then showed women who have already taken the vaccine why they chose and why mothers have chosen to help their daughters, and in the end showing women that they have the power to choose to take the vaccine. Also, as the “Tell Someone” campaign was shown after popular women television shows, Merck bought a 60 second slot for HPV advertising before the “Sex and the City” movie in theaters. Merck’s research showed, “76 percent of young women between the ages of 19 and 26 described advertising they saw before a movie as entertaining. But here's the clincher: The same young women said they pay more attention to ads on a movie screen than on television." (Siers, 1).
In the 2008 campaign year, the department of health appointed Consolidated PR to manage the public relations campaign to continue to raise awareness of HPV and the Central Office of Information (COI) managed the pitch. In a press release titled, “Department of Health appoints Consolidated to deliver HPV Vaccine PR”, it is said that this campaign will run from May 2008 till April 2009. Liz Fay, Board Director at Consolidated who will lead the agency team said in this article, "This is a vaccination of huge significance in the war against cancer as it will save lives today and for generations to come. It's not without its complexities and challenges though so our job is keep the communications consistent, clear and open. Working closely with the other marketing disciplines, the role for PR is to keep the momentum going to ensure that girls and their mums feel informed and compelled to opt in”.
The newest set of commercials on television at the moment is commercials that go back the awareness tactic of providing important information about the HPV virus. Merck has made a much more simple commercial series that features only words on a yellow screen stating an HPV fact, and then a Merck logo comes into the corner as hpv.com is shown under the fact. The same commercial, only with different facts shown, is currently being run on television. This approach urges watchers to find out more facts about HPV by logging onto the Website where all of the facts that are randomly shown on the commercials can be seen at once and then you have the options of searching how to protect yourself and get all of the HPV information. This breaks away from the “One Less” and the “Tell Someone” campaigns because it does not issue women or girls telling others about the vaccine, but just gives a small amount of information about HPV to intrigue people to inform themselves about the virus, cervical cancer, and the vaccine that can help prevent this infection.


Execution
Merck’s established its message through a variety of commercials and Web sites. The “Tell Someone” campaign’s main focus was to educate young women and their parents by giving them information on what HPV is and how it can change into cervical cancer. It encouraged its audience to protect the ones they love by telling them the potential dangers of being infected with an HPV virus. Their Web site is designed in this way featuring facts on HPV and surrounded with statements such as, “Tell someone…Tell your best friend, your sister, your daughter”, and “Help protect your future and the future of those you love. Ask your doctor about ways to help prevent HPV and its consequences”. In implementing a campaign focused on education the Gardasil target audience, and its intervening audiences, it enabled Merck to start the publicity needed to make the demand for the vaccine strong as soon as it was available for use.
The “One Less” campaign and the “I Chose” campaign both were geared directly to the Gardasil vaccine, and both are directed to the Gardasil Web site. The “One Less” commercials are some of the most recognized where they show a number of young women from different backgrounds becoming one less women to battle cervical cancer by taking the vaccine. The “I Chose” campaign spoke to the same group of women, but it took an angle of showing everyday mothers with their daughters and stating that they chose to get their daughter vaccinated followed by other young women saying they chose to be one less. Gardasil is shown on these spots as the only vaccine to battle cervical cancer, there is no information on the HPV virus like there was in the first informative method through the “Tell Someone” campaign.
The newest campaign through HPV.com gears women to learn more about HPV. Through the other campaigns women learned the facts about Gardasil and the types of HPV that it prevents. The HPV.com Web site gives 20 easy to remember and to the point facts about HPV and what it means for women. The new commercials show one fact at a time and encourage watchers to go to the Web site and learn more. For women who have not had the vaccine that has been advertised for two years, this gives them the knowledge of what HPV is, that it is a serious infection for women, and now there is something they can do about it. The execution of Web sites and commercials is specific to the campaigns target audience and its intervening audience, and it follows the path of information women should have about HPV, Gardasil and cervical cancer. It has been able to look at new angles through different commercials and target women that may not have taken the initiative to protect themselves from HPV and, potentially, cervical cancer.


Evaluation
There were many studies conducted, and there are still studies being done, but all have shown that Gardasil prevents HPV types 6, 11, 16, 18. It was impossible and unethical to allow women to develop cervical, vaginal or vulvar cancers just to prove that the vaccine helped to prevent them. In an article titled, “The Value of Gardasil”, a doctor responds to false facts about Gardasil that the National Post included in its article, “Is the HPV Vaccine worth It?” Dr. Francois Bertrand, M.D., is executive director, medical research, for Merck Frosst Canada issued the response and he described Gardasil in a favorable medical matter. He explained that through many studies, some including 3,000 girls and boys ages 9 to 15, which answered three questions about the vaccine: whether the vaccine was safe, whether it worked and whether it was efficacious. In immune response studies, the vaccine created a strong immune response to fight against the virus when it appeared in the subjects. In the effectiveness studies, women from ages 16 to 26 were studied because it would not have made sense to use subjects for a sexually transmitted disease if they were never in contact with the virus because of this reason. The results from these studies showed that Gardasil helped protect females from the four types of HPV that Gardasil targets. Dr. Bertrand explains the type of medical burdens that women have to go through even with abnormal pap tests, “But the real point is that deaths from cervical cancer are just the tip of the iceberg. What about the 325,000 abnormal Pap results and the women who undergo colposcopies and biopsies because of them? Or the 36,000 cases of genital warts causing 85,000 medical consultations across the country every year? Can anyone estimate the financial and psychological burden of all this? HPV types 6 and 11 cause 90% of genital warts. Results published in The New England Journal of Medicine show that Gardasil is 99% effective in preventing those cases.”
Gardasil studies have shown that the vaccine is almost guaranteed to help prevent HPV infections of the four types it targets in subjects who have never been exposed to HPV. Some studies say it is 100% effective in preventing cancerous and precancerous cases. However, studies still show that women who are already sexual active can still benefit from the vaccine. Even if sexually active women have been exposed to HPV, it is not likely they were exposed to all of the HPV types; therefore, Gardasil will still prevent the four HPV types from occurring.
There have also been studies resulting in significant changes in abnormal pap tests. Abnormal pap tests were reduced by 43% compared to women who did not receive the Gardasil vaccine. This reduction was in tests for pre-cancerous cell changes and there was also a 16% to 35% reduction in milder pre-malignant cell changes (News medical). This study also found that Gardasil reduced cervical biopsies by 42% compared to women without the vaccine.
In my evaluation of everything I have read on Gardasil and HPV, Merck has found their niche in developing the first vaccine to battle four types of HPV. Two of which are responsible for 70% of all cervical cancer cases. The way they advertised the product through Web sites and commercials gave women the information they needed, even before the vaccine was available, to understand that infections with HPV can occur without any signs or symptoms and can potentially lead to cervical cancer. Being the only vaccine to help prevent this problem makes them the leader in the battle against cervical cancer. This also makes Gardasil prone to medical scrutiny and has had many objections to its attempts in mandating the vaccine. Merck was able to handle these problems by stepping back with its push to make the vaccine for young girls mandatory. The vaccine needs to establish its importance among parents of young girls and the commercials took a step in focusing on mothers who have chosen to get their daughters vaccinated.
In looking into adverse effects of Gardasil, I found some cases, other than the side effects that are included as a warning with the vaccine which are pain, swelling, itching, and redness at the injection site, fever, nausea, dizziness, vomiting, and fainting. There have been 11 deaths reported in 2007 that were said to be related to the Gardasil vaccine. In further looking into these reports, there was no proof that these deaths had any direct relation to the vaccine. Overall, the vaccine is the only preventative method against HPV types 6, 11, 16, and 18 and is working to expand the vaccine to help women up to the age of 45, and eventually will be extending the vaccine to men to further the attempts of lowering the number of cervical cancer cases.


Professional Interview
I was able to interview Dr. William Dickerman, my family physician who has been practicing medicine for 25 years. He has been giving the Gardasil vaccine for a little over a year now and recommends it highly. “I encourage my patients to get the vaccine. Cervical cancer is significant concern in women’s health and this is the only vaccine that prevents certain HPV’s.” When asked if any of his patients told him where they heard of Gardasil if it was not suggested by him, he said, “A lot of my younger patients said it was suggested by friends or family, and some of them already knew what HPV is and that Gardasil can help.”
Dr. Dickerman did acknowledge that there are some side effects to the vaccine serious ones can be avoided, “There are always some concerns when it comes to new medicines or vaccines, but there are certain criteria that doctors follow for each patient in checking their history and making sure there are no allergies to the substance in the vaccine.” In referencing side effects to the vaccine he also said, “I have only had one abnormal reaction to the vaccine and that was with your sister. On the first shot of the three shot series, about two minutes after the shot was given to her she fainted. It was not serious, as you know she woke a few minutes later and never had any reactions to the other two shots.” My younger sister did have a negative reaction to the first shot, but she has had a history of becoming fatigue and has fainted before when she needed a vaccine given to her.
Overall Dr. Dickerman felt that the messages given to women through commercials and on Web sites was positive. “As a doctor I highly recommend young women to get vaccinated, and I inform my patients about the risks of HPV infections. I think the efforts that Merck has put into educating women of Gardasil and what it does have been very effective and has made women want to help themselves by talking to their doctors.”

5 comments:

Peterson said...

I am hearing this "HPV" is first time.Very clear and informative article.I will recommend my friend to read this article.

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muebles aranjuez said...

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