Gardasil - Page 6

Gardasil: The Controversy Continues

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You have an 11 year old son or daughter. You go to the doctor for a physical or broken bone and he/she recommends a shot for the human papillomavirus or HPV. The name alone sounds horrifying, but then they tell you that this virus causes genital warts and [gasp] cervical cancer. You immediately want to surrender to whatever it is that the doctor is suggesting in order to protect your child. While HPV is the virus that causes these two medical problems, they leave out the fact that there have been many serious side effects, including death, linked to the vaccine. Here are some more interesting facts that I previously reported in Gardasil, Miracle or Deadly Virus?:

  • Researchers have identified 100 different strands of the virus, the Gardasil vaccine only protects against 4.
  • Sexually active individuals have an 80-85% chance of being infected with one of the identified 100 strands of the virus in their lifetime.
  • A healthy body can fight off the infection 80% of the time.
  • With early detection, thanks to the annual pap smear test, cervical cancer can be detected and successfully treated. In 2008, the CDC reported that 12,410 women in the US were diagnosed with cervical cancer. Only 4,008 women in the US died from cervical cancer.

We all want the best for our children. Most parents here the words cancer, genital warts and immediately jump to the conclusion that this vaccine was approved so it must be safe. However, according to the Vaccine Adverse Event Reporting System (VAERS) on the Center for Disease Control (CDC), where parents and patients can report adverse effects of any vaccine, “over 25 million doses of Gardasil and there was an average of 53.9 VAERS reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination, and 6.2 percent were serious, including 32 reports of death.” The ongoing controversy of how much of these reported side effects are mere coincidence or a direct correlation can’t be measured on the self-reporting site, but consider this:

As a parent or young adult does the risk of a 6.2 percent chance of a serious side effect to protect your child or yourself from 4 out of 100 strands of a virus that the body can fight 80 percent of the time worth it? What’s more, for the 20 percent of patients that will not be able to fight it off on their own, it is usually caught during an annual pap smear test and treated before causing any major threat to the individual’s health.

Why the controversy? Mainstream media touts that the benefits outweigh the good, while alternative news sites and blogs tell of the horrific side effects that ruined or took or ruined their daughters’ lives (and now it is recommended for boys as a preventative measure as they carry the virus). How do you decide what is best? The important thing to remember is that it is your decision. Look into all the research and decide the risk factors of both getting it and not getting it. Here are some important things to look into as you investigate.

Follow The Money

The US is one of the few countries that allow pharmaceutical companies to advertise on television. The broadcasting company that is paid by advertising revenues is probably not going to disapprove of a product that one of their advertising clients is selling in between news segments. Furthermore, Merck paid doctors to promote the vaccine. Health Impact News Daily estimates that Merck legally paid approximately $2,313,942.81 to doctors to promote Gardasil. How can we trust the doctors on the news to be trustworthy and not one of Merck’s paid advertisers? Talk to doctors you trust and ask them if they were paid to promote the vaccine. Get a second opinion, or even a third.

Furthermore, the following medical associations that promote the vaccine also received funds from the vaccine makers according to the Journal of the American Medical Association:

  • The American College Health Association
  • The American Society for Colposcopy and Cervical Pathology
  • The Society of Gynecologic Oncologists

Why Is It A Law?

Some states tried to mandate the vaccine as a law. Personally, I don’t believe any vaccines should be mandated by law, but especially one that is under as much scrutiny as Gardasil. Taking a closer look at the politicians who did, let’s again follow the money trail. Texas Governor Perry passed the law to mandate the HPV shot shortly after Merck contributed $6000 dollars to his campaign (amongst other ties to Merck); in California, Merck donated $39, 500 to legislators voting yea on AB 499 according to Cal Watch Dog. For more information on whether or not it is mandated in your state, please read Is Gardasil Mandated in Your State? for more information. You can get exemptions forms for mandated vaccines here.

The Billion Dollar Question – Does It Work?

In 2011, Dr. Diane Harper, lead developer of the Gardasil vaccine came out in a press release stating,

“The best way to prevent cervical cancer is with routine Pap screening starting at age 21 years. Vaccination cannot prevent as many cervical cancers as can Pap screening. Pap screening with vaccination does NOT lower your chances of cervical cancer – Pap screening and vaccination lowers your chances of an abnormal Pap test. Gardasil® is associated with GBS [Guillian-Barre Syndrome] that has resulted in deaths. Pap screening using a speculum and taking cells from the cervix is not a procedure that results in death. Gardasil® can be offered along with Cervarix® as an option to prevent abnormal Pap test results in those women who can make an informed decision about how much they value this benefit compared to the rare risk of GBS. If a woman has no access to Pap screening, receiving HPV vaccines may help reduce cervical cancer IF the vaccines last long enough. At this time, Gardasil® is proven to last for at least 5 years, and Cervarix® for at least 8.5 years. Health policy analyses show that there will be no reduction in cervical cancer unless the vaccine lasts at least 15 years.”

Not good press for either Merck or GlaxoKlineSmith, the maker of the HPV vaccine Cervarix. Currently, there are not booster shots of either vaccine, and the shot is highly recommended for children 9-12 because they are less likely to already have been exposed to the virus. Doing a little math, that means the vaccine will wear off around the ages of 14-20.5 (depending on which brand was administered) very likely prior to sexual activity! What’s worse is that prior to approval Merck informed the FDA that  if a person has already been exposed to HPV 16 or 18 prior to injection, then Gardasil increases the risk of precancerous lesions, or worse, by 44.6 percent.

The War Wages On

Conventional media and Merck sponsored doctors continue to promote this vaccine, while individuals and alternative news sites continue to warn the public against it. For mothers like Tracy Andrews, the war will never end. Her daughter is one of the unfortunate victims of the Gardasil shot who is permanently disabled because of it. Tracy and her daughter, Alexis, passionately advocate to parents and young adults not to get this vaccine. Together, they also fight to have this vaccine banned. Their story was featured on Lucine and they will also be featured in the upcoming documentary “One More Girl.” This documentary by ThinkExist Productions, plays on Gardasil’s advertising slogan “One less.” The documentary title means “one more girl affected by Gardasil,” while the Gardasil campaign means “one less person affected by HPV.”  The documentary is scheduled to be released in the spring 2013. A preview can be viewed here.

To Vaccinate Or Not To Vaccinate, That Is The Question

In the end, you should discuss the pros and cons with your medical professional and decide for yourself and your family what is best. Arm yourself with as much information as you can so you won’t be intimidated by scary words like “cancer” and “genital warts” and can make an informed decision.

Hormones Matter is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

 

By Jan Christian @ www.ambrotosphotography.com  Gardasil_vaccine_and_box.jpg: Jan Christian @ www.ambrotosphotography.com derivative work: Photohound [CC-BY-SA-2.0 (http://creativecommons.org/licenses/by-sa/2.0), CC-BY-SA-2.0 (http://creativecommons.org/licenses/by-sa/2.0) or CC-BY-SA-2.0 (http://creativecommons.org/licenses/by-sa/2.0)], via Wikimedia Commons

Wal-Mart to Offer HPV Vaccine

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Now, in addition to low priced groceries and other goods, your local Wal-Mart will offer nurse kiosks ready to inject you or your child with a variety of vaccines. Wal-Mart is joining other stores, like Walgreens and CVS, in offering walk-through health clinics. According to recent reports, Wal-Mart will be the first to offer the controversial HPV vaccines Gardasil and Cervarix.

At Hormones MatterTM, we have written a lot about Gardasil and the HPV vaccine questioning its safety. Gardasil: Miracle or Deadly Vaccine?, Is Gardasil Mandated in Your State?, What About the Pap Smear?. For a very heartbreaking story at the dangerous side effects of this story please read A Ruined Life from Gardasil. HPV is a very common virus that many experts believe the body can fight off by itself; with annual pap smear tests a doctor can easily catch and remove any abnormal cells before they become cancer.

The trend of selling direct-to-consumer vaccines, like that of selling over-the-counter medications is time-saving and logical on the one hand, but is troubling on the other, especially with vaccines and medications that have less than stellar safety profiles. Any product sold direct-to-consumer comes with the false presumption that it is entirely safe. Indeed, we have consumer protection agencies to ensure that this is the case with most products. Consumers often mistakenly assume that over-the-counter medications are safe because there is a consumer protection agency protecting their well-being, otherwise the product would not be on the market. Unlike a toy with a choking hazard or a product batch with a chemical contaminant, where the cause and effect are obvious and easily remedied with recall, the direct side-effects or adverse reactions of medications or vaccines are difficult to recognize and more difficult to prove, even under the most regulated of circumstances. When medications or vaccines are sold over-the-counter, it is nearly impossible.

The over-the-counter vaccines effectively remove any ability for physicians, researchers or patients identify side-effects. Selling over-the-counter vaccines is a boon to the pharmaceutical industry, however. With this single move the industry can sell more vaccines, the vaccines become safe in the eyes of the consumer while the industry removes the ability to prove otherwise, and a brilliant, albeit less than ethical, corporate strategy is pushed on consumers.

What do you think, should vaccines be available at the local pharmacy?

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

A Ruined Life from Gardasil

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This was submitted by Tracy Wolf, the mother of Alexis who has suffered severe side effects from the Gardasil vaccine, this is her story. We thank Tracy for sharing.

In the spring of 2007, Alexis was a happy, shy, and well-adjusted 13-year-old, young lady. She had been diagnosed with type 1 diabetes in January of 2006, but responded to this in the most positive way. Her doctors were so impressed with how well she dealt with it that they recommended she be put on the insulin pump. Through all of this she worked hard, made the honor roll at school and was educating her fellow students about Type 1 diabetes. Her grandparents wanted her to visit them in Germany, but we were reluctant to do this because of the diabetes. Her doctor felt that she was so responsible and mature compared to other kids her age with Type 1, that she should be allowed to go.

In March of 2007, I took Alexis to see her pediatrician for a wellness check up before her trip to Germany and she received her first Gardasil injection. Alexis asked for it to be given in her leg. We did not notice any side effects at that point. In June, we returned to the doctor’s office right before Alexis left on her trip for the 2nd of 3 injections for Gardasil. Again there were no immediate side effects. A couple weeks later she left for Germany. While she was in Germany most everything went well. Her grandparents said she did act a little strange and out of character for her, but nothing they thought to be too serious.

When Alexis arrived back home from her trip, I noticed that she did not experience jet lag like we all had the last time we all went to Germany. Also, I thought it was odd that she didn’t (or couldn’t) cry when she was told that our 12-year-old dog had passed away while she was gone because she had always been a very sensitive child. As time went on more and more strange behavior, very unlike Alexis, started. She was getting in trouble at school and was unable to concentrate or retain anything she learned. I was taking her to every kind of doctor I could think of, but every test came back normal. Things progressively got worse. At this point her personality had changed 100%. She would go through bits of rage and she would scream at me and call me names and tell me how much she hated our family and me. She said she wanted to be taken to an orphanage and be adopted by another family. At this point doctors and school staff were telling me that Alexis was acting out and testing her boundaries. I argued with all of them. I knew there had to be something medical going on, although doctors and the school were not listening to me. She started having massive panic attacks where her heart would pound so hard you could see her chest moving. Sound and movements bothered her. She would talk about “things looking funny or strange.” she said that peoples faces made her sick to her stomach including people on TV and everyone around her. Often, she would look around as if she didn’t know where she was.

Soon I realized that she was not sleeping at all. She stayed up in her room writing notes all night. The notes were nonsense. She became obsessed with food and would eat anything she could get her hands on while we were asleep. I didn’t realize this at first because she was still being pretty responsible with her diabetes and giving herself the insulin she needed to correct for the food she was eating. One day she stuck her tongue out at me and I noticed a huge bump on the side of her tongue. She had no memory of how the bump got there and it was so big it looked like she had bit off a chunk. Looking back now, I think this is when the seizures started in her sleep.

I took her back to see her endocrinologist and at that point her doctor suggested that we see the in office psychologist thinking that maybe she was having issues being a diabetic. I told her that I really didn’t think it had anything to do with her diabetes, but she wanted us to try. On the second visit with her psychologist, the doctor came to the conclusion that Alexis had been sexually molested while she was in Germany. I was so upset and asked her why she thought this. She said that Alexis talked about seeing nudity in Germany (hello, have you ever been to Europe?) Nudity is everywhere in Germany and I talked to Alexis about this for many hours and on different occasions. Alexis swore to me that nothing like that happened in Germany. I spoke to her grandparents about it and they said that nothing like that happened. Seemed like the only one that believed that really happened was the psychologist (months later she apologized for being wrong, but at that point every doctor after that was subjected to her notes. I was labeled as a “mother in denial”). We were sent to other psychologist and psychiatrist. The only thing they knew what to do was throw anti-psychotic medications at her. Nothing worked, she only got worse. She started throwing up everything she ate, and then couldn’t wait to eat more.

By January 2008, I had taken her in to see her pediatrician again and she was given the 3rd shot in the Gardasil series. Things got much worse after that. Two weeks later we were back at her pediatrician’s office because she had lost five pounds in a week, was throwing up a lot, and not sleeping at all. The doctor sent us to the hospital. Alexis was admitted and spent the next four days getting blood tests, MRIs and a CT scan. Everything came back normal. I was told, once again, that nothing medical was wrong with my daughter. They sent her to Kaseman Behavioral Unit. There she was treated like an animal. They put her on many more anti-psychotic medications, none of which helped her sleep or stopped the vomiting. They told her that if she threw up her food she would not get anything else to eat. They seemed to have no idea how to deal with her diabetes and I had to constantly show them how to deal with it. She was not allowed to be around any of the other children and was told she could only be in her room or walk up and down a short hall. They gave her a bucket for the vomit and on the fourth day two nurses witnessed her eating her vomit from the bucket. After five days of being admitted, they said she was stable and sent Alexis home. That day she was not able to keep any food down and she did not sleep at all that night. The notes were lined up on the banister the next morning when I woke up.

The next day, we were told to take her to a new psychiatrist. We did and the doctor was almost in tears. She had no idea why we were sent to her. She could see right off the bat that she would not be able to help Alexis. She told us that she thought we were getting the run around. We went home and called her pediatrician and begged her to help us. She was reluctant but said she would make some calls and get back to us. We were able to get her into the Children’s Psychiatric Hospital at the University of New Mexico Hospital. This was on a Friday night and their psychiatrist would not be in until Monday so they just tried to focus on getting Alexis to sleep. They gave her high doses of Trazadone and she still didn’t sleep. The next morning I went to see her and she was sitting in a chair in the front room and she was slumped over and drooling and moaning. When I walked in, she slowly raised her head and almost in slow motion said, “Hi mommy.” I got her up and took her to her room and tried to get her to lie down and try to sleep. She started dozing off and I thought Yeah, she is going to sleep! But within five minutes her face clenched as if she were in pain, her eyes twitched, and her mouth filled up with saliva. They noticed right away that Alexis was not going through behavioral issues. When the doctor showed on Monday morning I told her exactly what was happening and while I was telling her, Alexis had another “spell.” The psychiatrist noticed right away that she was most likely having seizures. An EEG was done and they found out she was in fact having seizures that were all concentrated in her frontal lobe, the part of our brain that control our personality. She had been having seizures some time and no one noticed, until just then!

Alexis spent the next six months at UNMH. They did every medical test on her that they could come up with: EEGs, CT scans, MRI’s, 2 spinal taps, muscle biopsy, blood tests were sent out all over the United States, plasmapheresis, IVIG, and then some. Everything came back normal. They determined that she was exposed to a virus and her body made antibodies to attack the virus. However, she had not been sick and had not shown any symptoms of having a virus or even the sniffles. The only virus she had been exposed to was the Gardasil shots. They also determined that she suffered brain damage because of the seizures. She now is testing at a 4th grade level and still to this day is unable to attend school. She has seizure activity every day and night, almost constantly. She is in constant pain and no medication seems to help. Every day more symptoms pop up. She has numbness in her arms and legs, headaches, horrible pain, loss of bladder control (now she has to wear adult diapers), constipation (and when she is able to have a BM they are the size of a grapefruit and plug the toilet every time), vision problems, memory loss, brain fog, chronic fatigue, leg cramps, back pain, dizziness, she repeats the same things over and over again with no memory of having said it a million times, she is unable to retain anything that is said to her or that she sees, rapid heart rate, high blood pressure, and more

In 2009, she spent four days in the local Presbyterian hospital for high heart rate and super high blood pressure. All the tests came back normal. In November, I took her to Barrows Neuro in Phoenix. She spent six days attached to an EEG machine and under went another MRI. All the doctors were baffled and don’t know what to do. Her neurologist is very experienced and has never seen anything like what Alexis is going through.

We are all heart broken that a girl who showed so much promise three years ago, had her life as we knew it taken away. She will never be the same. We are pretty much out of options and our next step is getting an adult neurologist to look over her case to see if she would be a candidate for Vagus Nerve Stimulation or VNS therapy. This would mean having surgery to implant a device in her chest that would send impulses to her nerve endings in the base of her skull to try to stop the seizures. Alexis is scared and does not want to have this done, but I feel we have no other choice because none of the anticonvulsants are working.

Lawyers have refused to include Alexis in their class action lawsuits against Gardasil because her first symptoms were more “behavioral”. We now know that her behavior change was due to seizures. I spend most of my time trying to get Alexis special services that our government provides to people who have traumatic brain injuries, but I was told Alexis is on a waiting list of over 47,000 people in New Mexico and it could take up to 10 years for her to receive any benefits because there is no money to support the people in need. This is such a horrible nightmare that I wish we could all wake up from, but unfortunately this is real, very real.

Thank you for taking the time to read Alexis’ story. Some of these things are very hard to talk about and probably hard to read as well, but we all need to know what is happening to our children and be able to make educated decisions.

Alexis will be featured in the upcoming documentary One More Girl.

To read an update on Alexis’ condition: A Day in the Life of Alexis Wolf: Six Years After Gardasil.

Participate in Research

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey.

To take one of our other Real Women. Real Data.TM surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

Alexis after receiving the vaccine

 

 

 

 

 

 

 

 

 

 

Is Gardasil Mandated in Your State?

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Last week I reported on the controversy of the Gardasil Vaccine produced by Merck (it is important to note that GlaxoSmithKline also makes an HPV vaccine called Cervarix). Many women left comments which confirmed my statements and research with personal stories of their once healthy daughters who are now sick and disabled from this vaccine. This week I will look at which states are mandating that school children get the vaccine and one state that passed legislation for the vaccine to be given to children as young as 12 years old without parental consent.

As I stated in my op-ed piece on the Affordable Health Care Act, I am a libertarian. One of my main concerns about the government controlling our health care is mandated vaccines. To those who think that this could never happen, the simple fact is it’s already happening in our schools and in our military. While I’m a proud Marine, I’m ashamed of the fact that the government has been known to conduct ethically questionable experiments on our troops. In my opinion, vaccines are one of those experiments and rather than do they protect the patient, they ask will the people blindly take them?

While in the Marine Corps, I was vaccinated against every possible disease that there is a vaccine for not once, but twice, sometimes even three times (somehow my shot records never made it to my medical records, which I understand is common in the service). This includes the HPV vaccine, Gardasil. When I say it was mandated, I do in fact mean that I was forced to get these vaccines. Per the Uniform Code of Military Justice (UCMJ) my body was property of the US Government when I was in the service. You probably think I’m kidding; I’m not. During safety briefs before summer holiday weekends we were told to wear sunscreen (check out the dangers of sunscreen here) because if we got a sunburn while off-duty we could be charged with destruction to government property. Now, that was a little extreme and I don’t know anyone who was actually charged over a sunburn (although it wouldn’t surprise me), it was still true – we were government property. I tried to avoid the Smallpox vaccine and successfully did until we were at the airport terminal boarding the plane for Iraq, I was informed by our unit’s corpsman administering it, “If you don’t get this shot you can’t deploy.”

I sarcastically replied, “Okay,” only to turn around and see the Executive Officer (XO) standing behind me.

Not amused by my sarcasm, he said, “If you don’t get the shot I will charge you with disobeying orders Lieutenant.” He was dead serious.

Thankfully, I have not had any major complications (although the more research that I do, I think I have some ongoing side effects from the Gardasil vaccine).

State Mandates

According to the National Conference of State Legislatures (NCSL) school vaccine requirements are determined by individual states, a right which might be revoked now that states are mandated to enforce individuals to purchase insurance per the Federal government.

In 2006, the Michigan Senate was the first to introduce legislation (S.B.1416) requiring girls entering sixth grade to have the vaccine. The bill was not enacted. According to NCSL, “Since 2006, legislators in at least 41 states and D.C. have introduced legislation to require the vaccine, fund or educate the public about the HPV Vaccine and at least 21 states have enacted legislation, including Colorado, Indiana, Iowa, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, Nevada, New Mexico, New York, North Carolina, North Dakota, Rhode Island, South Dakota, Texas, Utah, Virginia and Washington.”

In February 2007, Texas Governor bypassed state legislation and made an executive order that all females going into the sixth grade had to get vaccinated with Gardasil. In May 2007, state legislators introduced and passed the bill H.B. 1098 to override the executive order. 

The Virginia legislature also passed a school vaccine requirement for Gardasil in 2007. To see what legislation related to the HPV vaccines and information has been introduced to your state, see NCSL’s chart here.

No Parental Consent Necessary

Can it get worse than mandating parents to give their kids a vaccine that causes severe side effects and does nothing more than an annual pap can do to prevent cervical cancer? Of course it can. On January 1, 2012, California’s Governor Jerry Brown signed the bill AB 499 into law. It states:

“Existing law authorizes a minor who is 12 years of age or older to consent to medical care related to the diagnosis or treatment of an infectious, contagious, or communicable disease if it is related to a sexually transmitted disease. This bill would additionally authorize a minor who is 12 years of age or older to consent to medical care related to the prevention of a sexually transmitted disease.  Time-critical preventive services for sexually transmitted diseases include the hepatitis B vaccine, post-exposure prophylactic (PEP) HIV medication (which must be administered within 72 hours of exposure), and the human papillomavirus (HPV) vaccine, which, if given prior to exposure, may significantly reduce the risk of certain cancers.”

How did we get here?

This is the easy part. Look at who is benefiting the most -follow the money. In this case, the makers of the vaccines are obviously going to benefit if their product is mandated by use of all children the age of 12-26 years old. Similar to when Texas Governor Perry passed the law to mandate the HPV shot shortly after Merck contributed $6000 dollars to his campaign (amongst other ties to Merck); in California, Merck donated $39, 500 to legislators voting yea on AB 499 according to Cal Watch Dog.

The cost of one shot is $120 and the vaccine is a series of three given over the course of a year. That’s $360 for every girl and boy who gets the vaccine. In most states insurance is mandated to cover this vaccine and there are numerous state and federal programs for those who do not have insurance. With all the side effects and even deaths from this shot, why wouldn’t politicians put those tax dollars to use providing un/under-insured women access to pap smears, a screening test that can catch HPV before it develops into cancer far enough in advance that fairly simple steps can be taken to stop cancer before it even develops? Why, because Merck and GlaxoKlineSmith can’t profit from preventing cancer that way. And how much has Merck made from the Gardasil vaccine? According to CNN Money, Gardasil grossed over $1.1 billion in the first nine months on the market. Unfortunately for Merck, the initial sales momentum has flattened out and is declining. The American public are obviously not buying this vaccine, so Merck and others are going to legislators and to have it mandated instead.

What can you do?

As I always say, GET INVOLVED. Get educated. Complacency, apathy and ignorance are how we got to this point (and Citizens United).  Be wary of a bill that puts a private company’s profits above the safety and well-being of the individual, especially one that involves the health of your child. It is incumbent upon all of us to assess the safety and risks of any medication or vaccine before taking it.

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

Further Reading:
Gardasil: Miracle or Deadly Vaccine?
What about the Pap?

Gardasil: Miracle or Deadly Vaccine?

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I normally don’t speak for a larger population because we are all unique individuals; however, I think in this case I can speak for all women. Dread is the only emotion that is drudged up when you get the friendly reminder card in the mail that it’s time for your annual appointment. Stripping down and wearing a stiff hospital gown with your feet up in cold metal stirrups while a doctor sticks a cold, duck-lip looking contraption up your nether regions for a Papanicolaou (pap) test. I don’t think there is a single woman on earth who enjoys this necessary torture, but it is the primary way to detect diseases and/or conditions including cervical cancer.

That is until 2008, when Merck released a vaccine that is advertised to protect against the strands of the Human Papillomavirus (HPV) that cause cervical cancer and genital warts. The shot is being administered to young girls and boys (who can carry the disease, but do not suffer from any health conditions because of it). The shot is administered to girls ages 11-26 years-old and boys age 9-26 years old, but do the pros outweigh the cons? I’ve heard of doctors tell parents, I wouldn’t give this shot to my own child, how can I recommend it to my patients. And I’ve heard doctors say, it’s the greatest vaccine we have that actually protects against cancer.

Let’s look at whether or not prevention outweighs the serious side effects and risks.

HPV

Carolyn Vachani, RN, MSN, AOCN writes that, The Human Papilloma Virus (HPV) is one of the most common sexually transmitted infections (STI) in the world. It is estimated that 5.5 million people worldwide are infected annually. Sexually active individuals have an 80 to 85% chance of being infected at some time in their life.” It’s not just a sexually transmitted infection; the virus invades the epithelial cells (type of skin cell) on other parts of the body including the oral mucosa, esophagus, larynx, trachea, and conjunctiva of the eye. Further more Vachani writes, “Researchers have identified 100 different strains of HPV, 40 of which can infect the anal and genital areas.”

On Merck’s Gardasil website it boasts, “GARDASIL is the only human papillomavirus (HPV) vaccine that helps protect against 4 types of HPV.” So, what about the other 96 strands, 36 of which infect the anal and genital areas?

Like HIV, there is no cure for HPV; but unlike HIV, the body can fight HPV and win 80% of the time. For the 20% whose body cannot fight off HPV there is a risk that cervical cancer can develop. If it is a strand that causes genital warts there are various methods to treat and get rid of the warts until the body is able to fight off the infection on its own.

Cervical Cancer

In spite of the high odds the body can fight off an HPV infection, cervical cancer is the second most common cancer in women worldwide. Forty years ago, cervical cancer was the leading cause of death of women in the US, but thanks to the availability of the pap test that has decreased 75% over the past 50 years. With annual pap tests, precancerous cells can be detected and removed from the cervix rather simply. According to the CDC, in 2008:

  • 12,410      women in the United States were diagnosed with cervical cancer.
  • 4,008      women in the United States died from cervical cancer.

Those numbers are low compared to developing countries. Out of the approximately 500,000 new cases of cervical cancer annually, 83% are in developing countries. The annual death rate of cervical cancer worldwide is approximately 273,000, of which developing countries account for 75% of the deaths.

There are no symptoms of cervical cancer and no way to detect it except a pap test, which isn’t available in most developing countries explaining the higher mortality rates. A vaccine that protects against the most common strands of the virus is better than nothing, right? Well, let’s take a closer look and see what the controversy is all about.

Gardasil

FDA approved Gardasil on June 8, 2006. As Chandler Marrs reported in Why Few Women Trust the FDA, the FDA doesn’t always have the best record in women’s health, making it difficult to believe everything they pass is safe or effective. The vaccine is a series of three shots taken over the course of a year. On the FDA website it states, “Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations.”

How many deaths and serious side effects are acceptable for the FDA? Apparently quite few; Natural Society reports, “Between May 2009 and September 2010 alone, Gardasil was linked to 3,589 harmful reactions and 16 deaths. Of the 3,589 adverse reactions, many were debilitating. Permanent disability was the result of 213 cases; 25 resulted in the diagnosis of Guillain-Barre Syndrome; and there were 789 other “serious” reports according to FDA documents.”

What does the FDA have to say? “Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of December 31, 2008, 32 deaths had been reported to VAERS [Vaccine Adverse Event Reporting System]. There was not a common pattern to the deaths that would suggest they were caused by the vaccine.”

On the website Classaction.org, where you can get legal advice on class action law suits against the makers of Gardasil if you or your child has suffered from side effects, they state, “As of Feb. 14, 2011, the CDC has reported that there have been 51 reports of deaths among females who received the HPV vaccine. A total of 32 of these death reports have been confirmed, meaning that a doctor has reviewed the report and any associated records. There have been two reports of deaths among males who were injected with Gardasil.”

That is just in America where cervical cancer can be detected early with annual pap tests. The vaccine against HPV is given worldwide to girls and boys to prevent spreading of HPV. It is now marketed as prevention against anal cancer even though only 10% of women with HPV will develop cancer and  cancer associated with HPV is only responsible for 1% of all cancer deaths.

Judicial Watch

In 2011, Judicial Watch, a conservative, non-partisan educational foundation that promotes transparency, accountability and integrity in government, politics and the law stepped in. They reported that they, “received new documents from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act (FOIA), detailing reports of adverse reactions to the vaccination for human papillomavirus (HPV), Gardasil. The adverse reaction reports detail 26 new deaths reported between September 1, 2010 and September 15, 2011 as well as incidents of seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss and Guillain-Barré Syndrome. The documents come from the FDA’s Vaccine Adverse Event Reporting System (VAERS).”

The report also states, “Not only will Gardasil not cure pre-existing HPV, it can also make symptoms worse. Women who already have the virus without knowing it could suffer massive outbreaks of genital warts or abnormal precancerous lesions, both of which require extensive treatment.” The vaccine is suggested for women who test positive for HPV in order to prevent them from contracting the other strands. (The 25 page report can be viewed here.)

Conclusion

Merck’s website advertises “You/your son or daughter could be one less person affected by HPV disease.” It is important to research all the possible side effects and the rate of occurrence, as well as your/your daughter’s ability to have annual pap tests before making this decision. We are all exposed to numerous strands of the HPV virus. Of the 100 strands, 40 are contacted through sex or genital skin contact. Of those 40, Gardasil only protects against the 4 most common strands because adding more strands to the vaccine caused even more severe side effects. In 80% of the cases of genital HPV, the body fights off the infection. With pap tests, doctors can detect cervical cancer before it becomes deadly (as long as women are getting them done annually). As much as we all hate that annual appointment, it may be a better solution to stick our legs in the stirrups for an exam rather than risk the side effects of the Gardasil vaccine. You decide.

Next week, I will look at how Gardasil was approved by the FDA, how states are mandating it for school children, and how states are passing legislation to make it legal for health professionals to administer the shot to minors without parental consent.

Additional Resources

IARC Monographs on Human Papillomavirus Virus and Studies of Cancer in Humans

Is Gardasil mandated in your state? Read more here
How does a Pap Smear Test prevent cervical cancer? Read more here.

Participate in Research

Hormones MatterTM is conducting research on the side effects and adverse events associated with Gardasil and its counterpart Cervarix. If you or your daughter has had either HPV vaccine, please take this important survey. The Gardasil Cervarix HPV Vaccine Survey. 

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