deadly side effects of HPV vaccine

Gardasil Research versus Marketing: The Reality of One Less

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Back in 2006 when the Gardasil commercial first aired, the marketing mavens at Merck had us all humming along about how we wanted to be ‘one less.’ Now – 7 years and a myriad of articles, claims and additional research later, the question remains; what does it mean to be ‘one less’ and is it worth the price?

What is Gardasil? Gardasil is a vaccine approved by the FDA and recommended by the CDC as a preventative measure against four strains of HPV that are known to cause 70% of cervical cancer cases and 90% of genital warts. The vaccine must be administered over the course of a year via several injections. It is recommended for those who are not yet sexually active (i.e. younger girls, aged 9-12).

What is HPV and how is it related to Cervical Cancer? There are over 100 strains of HPV (Human papilloma virus) with approximately 30 of them being sexually transmitted. Research has found that, in rare cases, approximately 10 of those 30 strains can lead to cervical cancer. Most women are diagnosed with HPV via an abnormal Pap test. There is no cure for HPV and in most cases the infection goes away and the virus remains dormant within the body.

It is estimated that at least 20 million people in the US already have HPV; with about 50 percent of sexually active men and women at risk for acquiring a genital HPV infection during their lifetime. According to the CDC every year in the United States, about 10,000 women develop cervical cancer, and 3,700 die from it. Although cervical cancer is the second-leading cause of cancer deaths among women around the world, it ranks between 15th – 17th for cancer death in developed nations such as the US and Australia.

What do we know about the effectiveness of Gardasil? Unfortunately, the answer is not much. Despite information put forth by the US CDC, Health Canada, Australian TGA, and the UK MHRA, the efficacy of Gardasil in preventing cervical cancer has not been demonstrated. According to an article published in the Annals of Medicine, the longest follow-up data from phase II trials for Gardasil are on average 8 years. However, invasive cervical cancer takes up to 20 – 40 years after initial infection to develop into cervical cancer.  Currently the death rate in the US from cervical cancer, according to World Health Organization (WHO) data (1.7/100,000), is 2.5 times lower than the rate of serious adverse reactions from Gardasil as reported by the Vaccine Adverse Event Reporting System (VAERS) (4.3 per 100,000 doses)

Since the vaccine is so new, and follow-up trials less than a decade old, the long-term health risks of Gardasil are still widely unknown. Adverse side effects have included death, convulsions, syncope, paraesthesia, paralysis, Guillain–Barré syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and pancreatitis.

Is it worth the cost? The vaccine only works against 4 HPV strains and annual pap screens are still needed to detect cervical cancer.  The full injection sequence costs an approximate 400 USD, which is more than the cost of a pap screen. This nullifies any cost savings from the vaccine. In countries where cervical cancer deaths are the highest (Uganda, Nigeria, Ghana), the cost of Gardasil makes it an nonviable option. Current research suggests that by targeting other risk factors such as smoking, the use of oral contraceptives and chronic inflammation in conjunction with the already recommended and proven effective annual Pap test, global minimization of cervical cancer is likely – at equivalent or higher rates than those hypothesized for Gardasil.

For now, until more is known on the effectiveness and risks of Gardasil it may be better to be one more who goes for their annual exam and partakes in safe sexual practices than being an undetermined ‘one less.’

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.

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

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.