Gardasil vaccineThe human papillomavirus (HPV) vaccines have been in the news frequently for the last several years.  Young girls are encouraged and sometimes required to have the series of three vaccinations, and now, the HPV vaccines are even recommended for young boys.  The governmental pressure to vaccinate, through mandates, school requirements, and criticizing parents who question the vaccines is growing, especially in the US, but also around the world.

I decided to do some research into the controversy when I read about a 2012 report in the British Journal of the Royal Society of Medicine of a study that evaluated the HPV vaccine marketing push in India by The Program for Appropriate Technology in Health (PATH), an organization with close ties to the Gates Foundation.  The problems the study uncovered intrigued me to look into this further.  I found a wealth of information and it turned out to be more complicated, more interesting, and more frightening than I expected.  Here’s what I found.

What is the human papillomavirus (HPV)?

The human papillomavirus is the most common sexually transmitted infection in the world.  The virus affects the “skin and mucous membranes, where they cause benign lesions, some of which have the potential to progress to invasive cancer.”  More than 80% of American women will have been infected by at least one strain of HPV by age fifty.  HPV infection causes almost all cases of cervical cancer.  There are at least 16 types of HPV that cause cancer, and two of those (HPV-16 and HPV-18) “cause 70% of cervical cancers, 80% of anal cancers, 60% of vaginal cancers, and 40% of vulvar cancers.”  An additional two types of HPV (HPV-6 and HPV-11) cause 90% of genital warts.  There are over 100 types of HPV and more than 40 types are sexually transmitted.

What are the vaccines and what do they do?

Gardasil (Merck) and Cervarix (GlaxoSmithKline) are the brand names of the two currently available HPV vaccines. Both protect against HPV-16 and HPV-18 and have been shown to prevent potentially precancerous lesions of the cervix.  Although no long-term study has been conducted to determine if the vaccines actually prevent cancer, it is assumed that they will protect against HPV induced cancers because they prevent HPV lesions.  The Merck vaccine, Gardasil, also protects against the types HPV-6 and HPV-11, which cause most genital warts.  The vaccinations can be quite expensive–the series of three vaccines can cost between $400 and $1,000.  The cost to a pediatrician is more than $300, and pediatricians often charge hundreds over cost.

How prevalent is HPV?

Although HPV is common, it is not widely prevalent due to its normally short duration–about 90% of infections clear within 2 years without any remaining effects.  According to one study, “At a given time, the overall prevalence of high-risk (cancer causing) HPV types was 15% of female participants; the prevalence of the types covered by the vaccine were 1.5% (HPV-16) and 0.8% (HPV-18).  The overall prevalence of low-risk (wart causing) types was 18%.  The two types covered by the vaccine were found in 1.3% (HPV-6) and 0.1% (HPV-11) of the population.  Overall, the types prevented by the vaccine were found in 3.4% of female participants.” The study’s conclusion: “the prevalence of HPV vaccine types was relatively low.” [emphasis added]  About 85% of cervical cancers and 80% of deaths from cervical cancers occur in developing countries, and most of those are in women who haven’t had a Pap smear in five years.

Are there potential benefits of the vaccine for women?

The vaccines are almost 100% effective against the two HPV types included in the vaccines; they prevent HPV infection, the cervical cancer precursors, and the genital lesions associated with those types.  The high effectiveness rate was only valid when analysis was restricted to those women who had never been infected with those types of HPV.  The vaccines cannot cure existing cases of HPV.  Since the vaccine is effective against only two types of cancer-causing HPV, and 30% of cervical cancer is caused by other types, it is recommended that vaccinated women continue to have regular Pap smear tests.

Both vaccines also protect against cervical dysplasia caused by HPV types 16 and 18, a condition that can lead to cancer, but rarely does, and can also be painful and costly to treat.  Up to 70% of cases of dysplasia return to normal without treatment, but the “greater the abnormality, the higher the risk for developing cervical cancer.”  Most cases of dysplasia can be detected with a Pap smear test and can be cured with treatment; survival rate is over 90%.

Are there any benefits for males?

The vaccine is now also recommended for boys, so are there benefits?  It seems that the primary reason for males to be vaccinated against HPV is to protect the women who will be their sexual partners, especially where vaccination rates for females are low.  The Advisory Committee on Immunization Practices of the CDC recommends the vaccine for boys of 11 and 12 to protect against anal and throat cancers.  In fact, based on the Committee’s recommendation, it would appear to be more cost effective to vaccinate only homosexual boys because the risk for cancer is higher for them.

Who is being targeted for the vaccination?

Since the vast majority of cases of cancer and cancer deaths from HPV are in developing countries, it would seem that administering the vaccine in those areas would yield the greatest health benefits; however, “Unfortunately for Merck, that is not where the money is.”  In the US and other developed countries, the primary beneficiaries of vaccinations, especially mandatory ones, appear to be Merck and GlaxoSmithKline.  On the other hand, providing unlimited vaccinations to developing countries who don’t even have clean water, sanitation, and enough nutritious food is also problematic. Here’s the response of one visitor to a remote village in Africa that had been given Gates Foundation vaccines: “I don’t care who you are or what side of the vaccine philosophy you fall under, there is no logic in the world that can explain going into a remote village with children who only eat one meal a day and have never had clean drinking water … and giving them a vaccine. Seriously?”

Since both Gardasil and Cervarix are preventive vaccines, they do not treat or cure active HPV infections.  To be effective, they must be administered before infection occurs.  The highest prevalence of HPV was among women aged 20 to 24.  The current recommendation is to vaccinate females from 9 to 25 years and to vaccinate males from 11 to 12 years.

What are the risks from the vaccines?

One possible risk would be the creation of a false sense of security.  The vaccines don’t protect against at least 14 types of HPV that cause 30% of cervical cancers, and women may not realize that they should continue regular Pap tests after vaccination.  Drug trials lasted about three years, so we don’t know how long the benefit will last or if there are long-term risks associated with the vaccinations.  I myself have seen a comment by a young woman who said she would prefer getting vaccinated to having to submit to a regular Pap smear.  She apparently didn’t know that the vaccinations don’t cover all types of cancer causing HPV and that she would continue to need the Pap test.  How many others believe like she did?

Some conservative groups in the US have opposed making the HPV vaccine mandatory for young girls due to concern for parental rights and from fear that it would lead to early sexual experimentation because of a false sense of immunity to sexually transmitted disease.

However, the most significant risks from the HPV vaccines are the serious adverse effects.  First, we’ll look at the official CDC lists of side effects.

Officially reported side effects of Gardasil:

The official CDC list of commonly reported side effects of Gardasil is similar to those from other vaccinations and include pain at the injection site (80%),  headache (33%), redness or swelling (25%), and fever (14%).  Other sources include Gardasil side effects of nausea (7%), dizziness (4%), and diarrhea (3%).  Slightly less common (more than 1%) side effects include vomiting, cough, toothache, joint pain, insomnia, sore throat, muscle pain, and dizziness.  More serious side effects that have been reported are very high fever; weakness, tingling, or paralysis (possibly signs of Guillain-Barré syndrome); and allergic reactions.  Rare side effects that have been reported include appendicitis, pelvic inflammatory disease (PID), airway spasms, blood clots in the legs or lungs, seizures, and Guillain-Barré syndrome.

Death and serious health problems such as stroke and blood clots are reported more frequently for Gardasil vaccination than for those receiving meningococcal vaccination.  Another source reports that although the rate of adverse side effects from Gardasil is similar to those seen in other vaccines, there has been a higher incidence of fainting and blood clots.

Officially reported side effects of Cervarix:

The official CDC list of commonly reported side effects of Cervarix is also similar to those from other vaccinations and include pain at the injection site (90%); redness or swelling (50%); headache and fatigue (50%); muscle or joint pain (50%); nausea, vomiting, diarrhea, or abdominal pain (25%); and fever (12%),   Although infrequent, some serious side effects have been reported, including high fever, behavior changes, seizures, fainting, and allergic reactions. Other sources report rare side effects including gastroenteritis, appendicitis, pelvic inflammatory disease (PID), airway spasms, blood clots, seizures, and Guillain-Barré syndrome.

Other reports of serious adverse effects from HPV vaccines:

Official reports of vaccine side effects are maintained in the Vaccine Adverse Event Reporting System (VAERS).  Unfortunately there is an insufficient investigation of the reported side effects (and many are not even reported by doctors) to determine the cause; therefore, much of our evidence is anecdotal–stories of young women who appear to have been harmed by the HPV vaccines.  One such case, a young woman named Amanda, may bear more weight than some others.  Her doctors were so concerned by her illnesses that they questioned giving the vaccine to their own daughters.  Amanda had a reaction after her first dose.  It began with soreness at the injection site and “eventually travelled [sic] down her arm, her legs, and led to a horrible autoimmune myofasciitis that is so painful Amanda had to go on morphine for the pain.”  She had been a high school varsity athlete before being vaccinated but now must take “a handful of pills a day just to keep her illness tolerable.  When she goes off the medicine, the excruciating pain and other debilitating symptoms return.”

A class action lawsuit is being brought against Gardasil manufacturer Merck in Australia led by Naomi Snell, a 28-year old woman who suffers from autoimmune and neurological complications after receiving the Gardasil vaccine.   After the first dose of Gardasil, she had convulsions, severe back and neck pain, and lost her ability to walk.  Unfortunately, at first her symptoms were diagnosed as multiple sclerosis (MS), so she continued with the second and third doses of the vaccine.  Her doctors eventually retracted the initial diagnosis and labeled her condition as a neurological reaction to the vaccine.  Others with similar complaints may join the lawsuit. [It’s important to mention here that although a lawsuit is possible in Australia, in the US, manufacturers of vaccines are shielded from liability by the National Childhood Vaccine Injury Act enacted by the US government in 1986.  The US Supreme Court upheld that shield with a decision on February 22, 2011, ruling that plaintiffs must go through the US compensation plan to seek damages, which are capped at $250,000.]

MS-like symptoms have been reported multiple times after HPV vaccinations. A 2009 study found that five cases of patients who had such symptoms within 21 days of receiving Gardasil “may be explained by the potent immuno-stimulatory properties of HPV virus-like particles which comprise the vaccine.”

Documents obtained from the FDA by Judicial Watch provide information about reports of deaths and serious injury filed in the VAERS database as Gardasil reaction events.  There were 16 deaths reported between May 2009 and September 2010 and 26 deaths reported between September 2010 and September 2011.  During the May 2009 to September 2010 time period there were 789 reports of serious effects, including 213 cases of permanent disability and 25 diagnoses of Guillain-Barré syndrome.

Is the HPV vaccination worth the risk and cost?

Here’s a summary of what we know about HPV and the vaccines.  Although Gardasil is very effective against the two HPV types, HPV-16 and HPV-18, the prevalence in the US of those types is very low, 1.5% and 0.8%, respectively.  Up to 90% of HPV infections resolve without any treatment within two years, and about 70% resolve within one year. Over 80% of HPV-caused cancers and cancer deaths are in developing countries, and most cancers occur in women who have not had a Pap smear within the previous five years.  Having the vaccination does not eliminate the cost and inconvenience of regular Pap smear tests and has not been proven to prevent cancer.  Even the Advisory Committee on Immunization Practices of the CDC is becoming “concerned about the cost effectiveness of vaccines, since the newest vaccines tend to be very expensive while protecting against diseases that affect fewer people.”

I found many studies and reports that evaluated the risks versus the benefits of the HPV vaccine.  Here are a few highlights from those that had concerns:

The British study that first caught my attention concluded that “the rate of cervical cancer [in India] is not high enough to justify the cost and risks associated with Gardasil and Cervarix vaccines.  Further, the authors noted that the rate of cervical cancer in India has dropped dramatically in a little more than 20 years, from 43 cases per 100,000 in 1982-83 down to 22 per 100,000 in 2004-05. . . . In the US and UK, the cervical cancer rate is less than half that found in India. This analysis found that giving the HPV vaccine makes no sense in light of both its cost and harmful effects. This doesn’t even consider the fact that no cause-and-effect connection between HPV and cancer has ever been shown, so there is nothing to demonstrate that the very expensive HPV vaccines even accomplish what they claim.” [emphasis mine]  The series of three vaccines can be very expensive, and the cost of medical treatment does matter because, if we spend limited resources on one disease or condition, we may not have enough resources for something much more serious.  If cervical cancer is rare and the cure rate is already very high, does it make sense to promote the HPV vaccine at such high cost and with such devastating adverse effects?

A study from the University of British Columbia found that “while the world’s leading medical authorities state that HPV vaccines are an important cervical cancer prevention tool, clinical trials show no evidence that HPV vaccination can protect against cervical cancer. Similarly, contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries. In the Western world cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination.” [emphasis added]  This study found that participants were not fully informed of the potential risks of the HPV vaccination.

Dr. Diane Harper, a researcher in the development of the vaccines and a consultant to the World Health Organization, once stated that “even if we get the vaccine and continue Pap screening, we will not lower the rate of cervical cancer in the US” because the rate of cervical cancer is already so low. [emphasis added]

An article published in the Journal of the American Medical Association (JAMA) on the Risks and Benefits of the HPV Vaccinations, says “if the potential benefits are substantial, most individuals would be willing to accept the risks.  But the net benefit of the HPV vaccine to a woman is uncertain.  Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened.  So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.”  [emphasis added]  The author questions the extreme push to vaccinate huge populations: “These educational programs strongly promoting HPV vaccination began in 2006, more than a year before the trials with clinically important end points were published. How could anyone be so certain about the effect of the vaccine?” [emphasis added]  Physicians and professional medical associations were provided with “ready-made presentations, slide sets, e-mails, and letters” to help market the vaccines before the study results were even published.  Why would anyone promote any medical procedure before clinical study results had been published?  Follow the money?

A 2010 report evaluated the adverse events that were reported following vaccination with Gardasil, including 49 deaths.  The evaluation concluded that the data “suggest a dose-response and temporal relationship to Gardasil.”  The study found that the adverse symptoms reported increased with each successive dose of the vaccination.  For those who died, onset of first symptoms was within three days of the injection.  One of the deaths was immediately following the second dose of vaccine.  One of the conclusions by the authors is that those experiencing adverse effects from early doses should seriously consider stopping the HPV inoculation process.

An analysis was performed after HPV DNA was found in the blood of a young Canadian girl.  HPV is a virus that does not survive in the blood stream for long.  HPV lives only on skin and mucous membranes.  Although the subject is complicated, finding HPV DNA in the blood apparently indicated that the Gardasil vaccine given to the girl had been contaminated with “recombinant viral HPV-11 and viral HPV-18 residues, both of which firmly attached to the aluminum adjuvant.”  Recombinant DNA is artificially genetically engineered, i.e., is man-made, and is considered a biohazard.  The study found HPV DNA contaminants in all samples from 13 lots of the Gardasil vaccine.  A major concern of this finding is that recombinant DNA might trigger autoimmune disorders in those receiving the vaccinations.  At the time of approval of the vaccine, both Merck (Gardasil) and the FDA said there was no viral DNA in the vaccine.  Determining whether the vaccine contained viral DNA was important because the DNA is a known to pose a health risk.

One analysis of studies that claim to support HPV vaccination found that the researchers “cherry-picked” the data, misapplied the data, or were sponsored by patent holders or financial beneficiaries of the HPV vaccines.

When an HPV vaccine mandate was proposed in Canada, the Canadian Medical Association said that “There is no epidemic of cervical cancer in Canada to warrant the sense of urgency for a vaccination program. . .”  Deaths from cervical cancer had already declined dramatically before the vaccine was introduced, and even high-risk strains of HPV rarely cause cancer.

What should you do and what questions should you ask yourself?

When the vaccine was first introduced in 2006, I thought it was great that scientists had come up with a treatment that could prevent cancer.  Fortunately for my daughters, they were already beyond the early recommended ages, and I was not required to make a decision about whether to give them the vaccine.  I am so glad now that they weren’t given the HPV vaccine because, when I began to research information about the HPV vaccines for this post, I was really surprised by the amount of information about the adverse effects and also disturbed by the insignificance of the possible benefits.  I feel like I had been fooled by the heavy promotion of the vaccines and the implied seriousness of the government mandates.  After what I have learned, if my children were that age today, I would not allow them to be vaccinated with Gardasil or Cervarix.  To make your decision, you must do as I have done and weigh the potential benefits against the potential risks as carefully as you can, including looking for more information through the sources below and other avenues of research.  You should ask yourself is it necessary and, especially, is it worth the risk. As the JAMA article said, the potential benefit of this vaccine is small; therefore, we should only be willing to accept a small risk of harmful effects.

Update, October 31, 2012: Cervarix, Like Gardasil, Doesn’t Do What Was Claimed: Research. This is important new information demonstrating that the vaccine trials did not show that they prevented cancer.

Update, November 13, 2012: UBC Researchers Advocate HPV Vaccine Scrutiny. “New research from the University of British Columbia (UBC) has provided evidence that Gardasil, a human papillomavirus (HPV) vaccine, may cause a type of inflammation in the brain involving blood vessels (cerebral vasculitis) that can lead to death.”

Update, May 1, 2013: HPV Vaccine Linked to Rare Disease with No Known Cure. “Gardasil and Cervarix are two of the 76 FDA approved vaccines included in the VAERS (Vaccine Adverse Event Reporting System) database. Since Gardasil was approved for use in the United States, there have been 682 reports of ITP after vaccine administration. 126 of these reports occurred after HPV vaccines. If all vaccines carried equal risk, there should only be 18 reports of Idiopathic Thrombocytopenic Purpura after HPV vaccine use.”

Update, June 19, 2013: Health ministry withdraws recommendation for cervical cancer vaccine. The health ministry [Japan] decided June 14 to withdraw its recommendation for a vaccination to protect girls against cervical cancer after hundreds complained about possible side effects, including long-term pain and numbness.  According to The Healthy Home Economist: “It is important to note that it is rare for the Japanese health ministry to withdraw a recommendation for a vaccine that is used regularly by local governments and is spelled out as part of revisions to the Preventative Vaccination Law approved in April 2013.”

Update, August 5, 2013: Have the HPV vaccines Gardasil and Cervarix been proven effective? A recent study claimed there had been a significant reduction in cases of human papillomavirus (HPV) among young girls following the introduction of the HPV vaccine Gardasil in 2006. There are many flaws in the study.

Update, August 9, 2013The Hidden Connection Behind Viruses, Vaccines and Cancer The “the CDC admits that HPV has never been isolated in culture. . . . Merck, the maker of the HPV vaccine Gardasil, presented information to the Food and Drug Administration (FDA) prior to approval that their vaccine increased the risk of pre-cancerous changes by 44.6% in women exposed to HPV types 16 or 18 pre-vaccination.  How many doctors do you know who test for the presence of these strains prior to administering the HPV vaccine?  I have yet to hear of such a doctor.”  [emphasis added]

Update, August 9, 2013: Scientists Explain Why HPV Vaccines Are Unsafe “There is no evidence that Gardasil or Cervarix can prevent cancer better than a decent screening program. There is strong evidence that they can produce severe and life-threatening harm. This report by 4 scientists documents how science has been corrupted & misused to promote these life-devastating vaccines. . . .  Indeed, Gardasil appears to have failed to meet a single one of the four criteria required by the FDA for Fast Track approval.”

Related Post . . .

VaccinationHave the HPV vaccines Gardasil and Cervarix been proven effective?



Sources (many of these sources have lists of further references):

Wikipedia, HPV vaccine,
Human papillomavirus (HPV) and genital warts fact sheet,
Prevalence of HPV Infection Among Females in the United States,
Cervical Dysplasia,
Prophylactic human papillomavirus vaccines,
Vaccination Bill Mutates,
Human papillomavirus, vaccines and women’s health: questions and cautions,
Food & Water, Nope. Vaccines, Yep.:
Brit Scientists Show HPV Vaccine Is Not Justified Anywhere,
Researchers Question If HPV Vaccine Is Worth the Risk
Panel Endorses HPV Vaccine for Boys of 11,
Herd Protection: Selling Gardasil for Boys with Bad Research,
The Risks and Benefits of HPV Vaccination,
Hi. My name is Christina Richelle Tarsell, but people call me Chris,
213 Women Who Took This Suffered Permanent Disability
Gardasil in court: drug’s maker sued
CNS demyelination and quadrivalent HPV vaccination
Other Adverse Reactions Include: Seizures, Paralysis, Blindness, Pancreatitis, Speech Problems and Short Term Memory Loss,
Judicial Watch Uncovers FDA Records Detailing 16 New Deaths Tied to Gardasil,
The National Childhood Vaccine Injury Act (Wikipedia),
Supreme Court upholds vaccine liability shield,
How Many More of these “Unavoidably Unsafe” Drugs Will Become Mandatory,

There are more than 3,000 videos on YouTube about anecdotal reports of adverse reactions to Gardasil,

The movie The Greater Good documents potential dangers of vaccines,

Photo credit: Gardasil vaccine

This post is linked on Freaky Friday 8/3/12.