Gardasil: “One Less” Terrible Decision

Amy Evans wrote the ‘Sustained Argument Essay below’ for a college course chronicling her adverse reactions after receiving the Gardasil vaccination for HPV.  As she explains it “I am interested in educating the public on the dangers of the Gardasil vaccine.  My goal for my readers is for them to become more aware of the risks this vaccine has, and for them to do their research before receiving or not receiving the vaccine.  I would like to bring awareness to the fact that consumers need to do their research and not believe everything they are told.

“My working thesis at this point is as follows: The Gardasil vaccine was viewed as a huge benefit to our society when it was first introduced, however further research has shown there are still various issues that need to be worked out.  Throughout this essay we will journey around these issues and the ways this vaccine in particular is harmful to those who choose to receive it.”

This is a brief overview of Amy’s history.

On July 20, 2009 – Amy at age 18,  received the 1st shot of Gardasil and she also received the Menactra vaccine (Meningococcal Meningitis). On the same day Amy received a prescription for birth control pills. Amy took her first birth control pill on July 26, 2009. Amy was vaccinated during the paramenstrum – the premenstrual phase and time of her period – when her immunity was at its lowest.

On September 24, 2009 – Amy received her second shot in the Gardasil series – and on Friday January 15, 2010 – she received the final shot in the series AND she had a EEG done for her sleepwalking episode. On the following Sunday, Amy was admitted to a clinic for a sleep-seizure study.

This is her story.

Amy Evans
Prof. Macklin
EN 201-2: Middle Draft
April 15, 2011

“One Less” Terrible Decision

Amy EvansThe typical college freshman does not “sleepwalk” into their resident advisor’s room on their first night at college. I am not your typical college freshman. On my first night of college I sleepwalked (I thought it was sleepwalking at the time) into my resident advisor’s room. My RA thought I had been drinking that night so she proceeded to call the head RA, which led to her calling the resident director, and then the RD (Resident Director) proceeded to call Campus Security. After being questioned many times from everyone as to whether or not I had been drinking that night, they came to the conclusion that I had not been, and that I had sleepwalked to my RA’s (Resident Advisor) room. They allowed me to go back to bed and I emailed my mother the following morning that I had a funny story to tell her about my first night at college. Good thing she didn’t think it was as funny of a story as I did. I was then required to have an MRI of my brain so I could run cross-country for the college, and nothing unusual was found. About three months later I had another “sleepwalking” episode the night before going home for Thanksgiving break. One of my fellow hall-mates found me in the bathroom and again it was assumed I had been drinking. I wouldn’t have even known I had an episode had I not found my flip-flop in the locked bathroom stall the next day. Near as I can figure, I had a seizure in the stall and crawled under the door to get out, and that is where my hall-mate found me. I again told my mother of this event and we just assumed it was sleepwalking and that maybe I was overly excited to go to college and then to come home for break. Then during Christmas break in Myrtle Beach, my family witnessed me seizing on the bathroom floor of our hotel room. The paramedics in Myrtle Beach were called and came to check the situation out. They asked me a few questions to get me to come to; they tested my blood sugar, and proceeded to leave shortly after. We already had a sleep and seizure study scheduled for when we got back from our vacation. Sometime after doctors’ visits, several electroencephalograms (EEG), a sleep study and blood work done, we reported to the Vaccine Adverse Event Reporting System, and they contacted me. VAERS informed me that I had a serious adverse reaction to the Gardasil vaccine, which I received prior to going to college. I was diagnosed with a nocturnal seizure disorder, and I am now taking Keppra, an anti-seizure drug, twice daily and I do not know what the long-term effects of this vaccine will be. As of now I will need to continue taking Keppra for at least the next two years, when my doctor will consider gradually decreasing my dosage until I am off the medication.

While Gardasil is beneficial to many women and teens, and most people have a low number of adverse reactions, this clearly isn’t the case for an alarming number of American women each year. Adverse reactions that are not considered life threatening include pain or swelling at the injection site, fainting, headache, nausea and fever. However a serious adverse reaction that is considered life threatening and may consist of hospitalization, permanent disability, life-threatening illness, or death (Gardasil side effects, 2006). Gardasil was introduced as a vaccine to prevent Human Papilloma Virus and Cervical Cancer. The Center for Disease Control and Prevention states that, “As of February 14, 2011, approximately 33 million doses of Gardasil were distributed in the U.S. Since then, VAERS received a total of 18,354 reports of adverse events following Gardasil vaccination in the U.S.  Of these reports, 92% were reports considered to be non-serious, and 8% were reports of events considered serious” (CDC, 2011). Aside from the 8% of females who have had serious adverse reactions, the vaccine is beneficial to the other 92% of the girls. The Gardasil vaccine was viewed as a huge benefit to our society when it was first introduced; however, further research has shown there are still various issues that need to be worked out. These issues consist of the reactions patients are having to the vaccine, doctors not telling their patients the details about the vaccine, and patients not reporting if they’ve had a reaction to the Gardasil vaccine. Another issue is that patients need to research the effects the vaccine can have on them.  

The Center for Disease Control states, “There have been fifty-one VAERS reports of deaths among females who have received the Gardasil vaccine. Thirty-two reports have been confirmed while the other twenty-nine remain unconfirmed.” While this is a low number of deaths considering the number of people who have received this vaccine, keep in mind that this is only one reporting agency’s death count. The list of serious adverse reactions has increased since it was launched into society. Those adverse reactions consist of “bleeding or bruising more easily than normal, bad stomach ache, seizures, muscle weakness, aching muscles, chest pain, shortness of breath, leg pain, generally feeling unwell, chills, unusual tiredness, weakness or confusion, joint pain, and swollen glands” (Gardasil, 2010). This list of serious adverse reactions was roughly half its length only a year ago, and seizures were not listed as a serious adverse reaction to the vaccine at the time. This vaccine should have had a longer trial period before it was released full swing into society.

Looking back on when the vaccine first came out to present day, the advertisements about the vaccine have all but disappeared. An example of this would be the mercks-2011-gardasil-advertising-campaignadvertisement “One Less” created by Merck, the manufacturer of the Gardasil vaccine, which promotes getting vaccinated. The commercial shows girls participating in different activities and sports, saying they want to be one less girl with cervical cancer and they can accomplish this by getting the vaccine. When the vaccine first came out in 2006 this advertisement was all over the media. Now ads for Gardasil are rarely aired on television or seen anywhere else in the media. This advertisement not being aired anymore is one example of how the government is withdrawing due to the fact that there is something seriously wrong with this vaccine. Though the medical field is still recommending it, the media is not pressuring people to get vaccinated as much as they were when the vaccine was first introduced.

In “Do boys need the vaccine too?” Pediatrician James Sears states that if a patient does not have insurance the vaccine costs seven hundred dollars out of pocket and the price is the only downfall of the vaccine. The manufacturers of the vaccine are aware of the cost so the vaccine would be a moneymaker for them and for anyone else in the medical field. Merck also recommends getting a booster shot about five years after the first series of three shots. Getting a booster shot would require making another payment, which would again go to Merck. If money is being made off a popular vaccine, such as this one, the government or anyone else involved wouldn’t speak up if they saw an issue with the vaccine itself. However with the government knowing there are some issues with the vaccine they figure maybe if it is not advertised it as much, people won’t think they are being pressured into getting vaccinated. This would lead to the medical field not telling the consumers of the side effects because they are making money off of it. This leads consumers to believe people in the medical field, and not research for themselves the harm of what they are potentially putting into their bodies.

This vaccine has a noticeable amount of problems that need to be worked out. If this is the case, why would the medical field introduce it to men and boys also? The medical field’s side to this argument is that though men won’t get cervical cancer, they are carriers of HPV, so by vaccinating men they are also helping women have a lesser chance of coming in contact with the virus. Why would they want to harm both genders when there is already a definite problem with the amount of women who have already been vaccinated?

In a general blog titled “Brother and sister stricken down by Gardasil HPV vaccine” found on Sanevax, a mother discusses the story of her daughter and son, both of whom received the Gardasil and Meningitis vaccine at the same time. The blog talks about when the daughter, Danielle, was first vaccinated she fell off the couch and had a Grand Mal seizure, but the doctors flat out told her parents it was not related to the Gardasil vaccine. Danielle had never done drugs or alcohol, and was not on any new medication, the only new thing in her body was the Gardasil vaccine. The family had to be questioned an agent from Child and Family services and an abuse case was opened on Danielle because the injuries from falling off the couch were so bad. Meanwhile, the son Chad, had also been vaccinated, and he was experiencing Grand Mal seizures as well. “A friend did some research on the internet, looking for unexplained seizures in teenage girls. She called me and asked if Danielle had ever been vaccinated with Gardasil.” The medical field denies Gardasil and seizures have anything in common; but if the seizures are not related to the vaccine what are they related to? Someone such as Danielle and Chad were both living a normal healthy life before this vaccine, and now they have days were they don’t even want to get out of bed; but there is no way it is related to the Gardasil vaccine right? The information is out there about the side effects, it just needs to be found and researched.

The way Gardasil was advertised was that it protects against cervical cancer, and most consumers viewed it that way. However when looking at the fine print and fully reading the information on the vaccine, one would realize that the vaccine does not protect against cervical cancer, and that it only protects against four types of Human Papilloma Virus that can later lead to cervical cancer. Those are types 6,11, 16 and 18, but there are many, many more types that Gardasil does not protect against. (Gardasil Side, 2006). So even if patients think they are preventing themselves against cervical cancer or helping to prevent HPV they are not because the vaccine only protects against four types. When Gardasil was first introduced it was the great new thing and most teen girls received the vaccine. What doctors did not tell their patients were the harms it could cause them. Patients were only told of the minor side effects that are caused by this vaccine, but as more consumers got the vaccine, more people started having adverse reactions to it.

3 Shots at PreventionThere is a problem with the number of girls who are having serious adverse reactions to the vaccine. HPV is a sexually transmitted disease, so if a consumer is not sexually active, the chances of getting HPV are slim to none; therefore they wouldn’t need the Gardasil vaccine. Many girls have received the vaccine even though they are not sexually active. As stated by Robert Aronowitz in a chapter from the novel The HPV vaccine and the politics of medicine’s simple solutions “…Infection by one of these HPV types… do not lead itself to cancer. HPV infection is common; cervical cancer is rare” (Aronowitz 2010, p.23). Only 10% of women with HPV end up with cervical cancer. If cervical cancer runs in the family of the consumer, that is a reason to get the vaccine, but if it does not and the consumer is not sexually active they are only harming themselves by getting vaccinated against HPV. Without knowing HPV is a sexually transmitted disease the girls are only increasing their chances of a serious adverse reaction, and not knowing if the vaccine will prevent them from getting HPV when they do become sexually active in the future. If consumers looked into these things before getting the vaccine, many girls would have saved themselves from going through what they might have gone through post-vaccination. But these girls are not the only ones at fault here.

It is a doctor’s responsibility to inform their patients of the side effects of the vaccine. Doctors do not tell their patients that they should not get vaccinated with Gardasil at the same time as another vaccine. In a Sanevax article titled Brother and sister stricken down by Gardasil HPV vaccine, the mother states “I questioned the nurse about the safety of getting both shots at the same time, and she said it was totally fine.” The mother was then handed a sheet of side effects that was last updated in October of 2007. Even if doctors are saying there is no harm in giving this vaccine with another, don’t give the patient an outdated side effect sheet, because as we have seen, more side effects have surfaced since the first round of vaccinations. Doctors deny the fact that there can be and may be greater side effects than those listed when Gardasil first came out. When asked if the reaction a patient has may be linked to the Gardasil vaccine, doctors simply brush it off as nothing. Consumers need to take action for themselves and do their own research, as doctors are obviously not fully aware of the risks. Consumers depend on people in the medical field to inform them of the dangers that they may face by getting vaccines of any type because consumers are not as knowledgeable as doctors are on these topics. However, the truth is that one needs to look out for his or her own well-being because no one else is going to. This is why consumers need to research all of the side effects of the vaccine, and what the life-threatening aspects of this vaccine are. The long-term effects this vaccine may have on a consumer or the serious adverse reactions one may have from the vaccine are still unknown.

Jared Diamond, an evolutionary biologist is best known for his big, best-selling books on the evolution of human societies. In one of his books, “Why do Some Societies Make Disastrous Decisions?,” Diamond talks about what societies are doing and how they are harming themselves and they don’t even realize it. An excerpt from the book will help to explain, “First of all, a group may fail to anticipate a problem before the problem actually arrives. Second, when the problem does arrive, the group may fail to perceive it. Then, after they perceive it, they may fail even to try to solve it. Finally, they may try to solve it but may not succeed.” (Diamond 2005, p.393). In relation to the Gardasil vaccine, the group that has failed to anticipate a problem would be Merck, the manufacturer of Gardasil. The problem is that Gardasil has more serious side effects than they anticipated. Due to the fact that this vaccine wasn’t tested over a long period of time, Merck didn’t have any idea of the long-term side effects; they still don’t know what those side effects may be in the future, such as sterility, paralysis, hair loss and other long-term side effects. For Diamond’s second part “when the problem arrives, the group may fail to perceive it,” the medical field refuses to take the blame for the problems Gardasil has caused, and doesn’t want to believe there could be something wrong with the vaccine. “Then after they perceive it, they may fail even to try to solve it,” (Diamond, 2005 p.393) even if these doctors and people at Merck realized there is in fact a problem they have done nothing about it. They are still ignoring the fact that this vaccine has done harm to so many girls. As for Diamond’s last theory of trying to solve the problem but not succeeding, the problems this vaccine has caused have not been fully studied.

Many people wonder why people who have reactions to the Gardasil vaccine don’t report it to VAERS or any other reporting facility. Most people don’t report if they’ve had a reaction because they cannot pinpoint it back to the Gardasil vaccine. Due to the fact that doctors don’t tell their patients of the severity of the side effects that may occur, most patients don’t even view the vaccine as an option as to why they are feeling abnormal. Many people don’t know that VAERS exists, because their doctor is supposed to fill out the reaction form. Consumers may also think that if they are having a minor reaction to the vaccine, it doesn’t matter if they report it or not because the reaction will go away over time. The truth is, it’s important to report if you are having a reaction and think it may be from the Gardasil vaccine. It is important to report a reaction so that the manufacturer can look at the statistics of people that are being affected by the vaccine and they may come to the realization that there is in fact a problem with their product.

Tell Someone In another advertisement for Merck’s Gardasil, a pamphlet titled Tell someone talks about how mothers should seriously consider getting their daughters vaccinated with Gardasil. This pamphlet gives information on the different types of HPV and how they are contracted. Merck uses scare tactics towards mothers stating “Mom, you’d want to know who she’s been talking to all day… wouldn’t you want information that could help her avoid cervical cancer in the future?” This pamphlet was from 2006 when Gardasil was first introduced. Merck is trying to use any means possible to get as many people vaccinated as they can against HPV. Nowhere in the pamphlet does it state anything about how Gardasil only protects against four types of HPV, or about how these young girls need to be having sex to get HPV, or the fact that only 10% of women with HPV actually end up getting cervical cancer later in their lives. The advertisement uses the slogan “tell someone” as a way to pass the word. Merck wants consumers to pass the word to each other about getting the vaccine and how it would “only benefit your daughter’s future.” “Telling someone,” means passing the word about getting the Gardasil vaccine, telling someone about the different types of HPV, telling someone how they can protect their daughter.

It would be beneficial to consumers if they did their research before getting vaccinated against HPV because most people think it will prevent them from getting cervical cancer in the future, which is not the case. Many doctors do not tell their patients the harmful things the vaccine can do to them, so consumers need to look out for themselves and do further investigation, even if the doctor says there is nothing to worry about. We never know when something can go wrong or even how something will react with different body types. Further research could prevent more patients from being harmed by this vaccine.

 

References

Aronowitz, R., Epstein, S., Livingston, J., Wailoo, K. (Eds.). (2010). Three shots at prevention: The HPV vaccine and the politics of medicine’s simple solutions. Baltimore MD: The Johns Hopkins University Press.

Center for Disease Control and Prevention. (2011). Retrieved April 15, 2011, from http://www.cdc.gov/vaccinesafety/Vaccines/HPV/gardasil.html

Diamond, J. (2005). Why do some societies make disastrous decisions?  In S. Greene & A. Lidinsky (Eds.), From inquiry to academic writing: A text and reader, (pp.390-405). Boston: Bedford/St. Martin’s.

Erickson, N. (2010). Gardasil/Silgard Victims from the United States. SaneVax General Blog. Retrieved from http://sanevax.org/blog/?p=922

Gardasil [Human Papillomavirus Quadrivalent (types 6,11,16 and 18) Vaccine, Recombinant]. (2010). Retrieved February 23, 2011, from http://www.gardasil.com/

Gardasil Side Effects. (2006). Retrieved February 23, 2011, from http://cervical-cancer.emedtv.com/gardasil/gardasil-side-effects.html

Masterson, L. Sears, J. (2011, March). Do boys need the HPV vaccine too?  Redbook, p. 72.

Merck. (2006). Tell someone [pamphlet].

One Less. (2006). [Commercial advertisement]. Merck.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.