gardasil research Archives - Hormones Matter

Gardasil Cervarix Online Study Continues – Participate Now

Published on July 18, 2013

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Controversy surrounds the HPV vaccines, Gardasil and Cervarix. Since their release, the vaccine industry, the media and medical societies have touted the safety and success of the vaccines in preventing or reducing HPV viral infections and thus, in preventing cervical cancer. Patient groups, mom’s of vaccine injured girls and anti-vaccine groups on the other hand, argue loudly that the rate and severity of serious adverse events are seriously under-reported by industry and the proof that these vaccines prevent or reduce cervical cancer is lacking. Even one of the lead developers of the vaccine, Diane Harper has come out against it.

Somewhere in the middle is the Vaccine Adverse Event Registry (VAERS), where only 1-10% of a very limited range adverse events are reported. Even with the limited reporting to VAERS, the severity and frequency of adverse events is growing and should not be ignored. Data collected from VAERS indicates a serious adverse event rate 4.3 per 100,000 doses of Gardasil. Serious adverse events are those that cause death or are life threatening, require hospitalization, cause persistent disability or incapacity and/or require medical treatment to prevent permanent impairment or damage. This is compared to a risk of cervical cancer of 7.9 per 100,000 and death from cervical cancer at 2.4 per 100,0000 cases in the US.

Considering the severity of the reported adverse reactions and the noted adverse events reporting rate of less than 10% of all cases, having more credible and complete data about true severity and prevalence of said reactions as well as more detailed data about who is at risk for those adverse events is critical.

As a parent, a researcher and the founder of Hormones Matter^TM, I decided to do something about the lack of data in this and other areas of women’s health. As part of the Real Women, Real Data series, The Gardasil Cervarix HPV Vaccine Survey was launched In May of 2013. It is a comprehensive, online study of Gardasil and Cervarix side-effects and adverse events. The study will run until a study sample of 1000 is reached. The goal is to provide a more accurate and unbiased look at the rate, range and severity of side-effects and adverse events associated with the HPV vaccines, Gardasil and Cervarix.

Take a survey. Share a survey. Suggest a survey.

We need your help to gather these data. Please take this survey, if have had either vaccine – whether you experienced any side-effects or not. Understanding who is at risk and who is not, is very important. Share the survey link with your friends, sisters, colleagues and anyone you know who has been given the HPV vaccine. Please post it on your Facebook pages and share on Twitter, Linkedin, Reddit and other social media. Write about and re-post this link on your blogs. Anything you can do to spread the word is appreciated. We will need at least a thousand women to find the connections.

It is up to us to protect our daughters. Understanding this vaccine is one way to do that.

Purpose the Gardasil – Cervarix Survey

Women and their physicians need more data about the side-effects of the HPV vaccines, Gardasil and Cervarix. There is a lack of data about who is at risk for adverse events and whether certain pre-existing conditions increase one’s risk for an adverse event. There is also a lack of data about the long term health effects of these vaccines. The purpose of this survey is to fill that data void; to learn more about the risks for and nature of adverse events associated with each of the HPV vaccines, Gardasil and Cervarix.

Who Should Take the Gardasil Cervarix HPV Vaccine Survey?

Girls or women who have been given either vaccine or the parents or other family members of young girls given the vaccine.

We are not currently collecting data on the adverse reactions for men and boys, but intend to launch a separate survey to tackle that population.

How Long Does the Gardasil Cervarix HPV Vaccine Survey Take?

This is a long survey. We felt it was important to assess the full depth, breadth, onset and severity of adverse reactions in order to give parents and women the data they need to make informed medical decisions. This necessitated a longer than desired survey. We estimate it will take approximately 20-30 minutes to complete the survey. We hope, given what is at risk, survey respondents will take the time to complete the entire survey.

Is the Survey Anonymous and Secure?

Yes. We do not collect personal identifying information and the survey is hosted with SSL encryption using a verisign certificate Version 3, 128 bit encryption.

How Will the Data be Used?

To inform future research and women’s health decision-making.

Who is Conducting this Research?

Researchers from Lucine^TM, Hormones Matter^TM. For more information on Lucine, click here. For more information about Hormones Matter^TM , click here.

What Can I Do To Help?

Our organization is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. Get involved and help us prove that hormones matter and that women’s health data matter. Become an advocate, spread the word about our site, our research and our mission. Join our team. Write for us, partner with us, help us grow. For more information contact us at: info@hormonesmatter.com.

To take the Gardasil Cervarix HPV Vaccine Survey, click here.

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.

Thank you in advance for your help.

Gardasil Research versus Marketing: The Reality of One Less

by Jordan Davidson

Published on March 11, 2013

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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 Matter^TM 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.

Is Gardasil Mandated in Your State?

by Lisbeth Prifogle, MFA

Published on July 30, 2012

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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 Matter^TM 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?