Health and Science

The Evidence on Gardasil: Modern Miracle or Dangerous Scam?

Originally published September 26, 2013, on www.thinkingmomsrevolution.com

If you’ve been following us for any length of time, you’ve probably noticed that we frequently point out the dangers of vaccination, because every single one of us knows countless children (and adults) that were injured by vaccines, some of them permanently.  In fact, we cover this subject so often that we are listed (page 39) in UNICEF’s report on “anti-vaccination influencers” in Eastern Europe.

Can I get a “Huzzah!”? Eastern Europe! Who knew we even had readers in Eastern Europe, much less that we were influencing them?

But the truth is that none of us started out “anti-vaccination.” We got there after a lot of investigation. And one thing we noticed toward the beginning of our investigations is that all vaccines are not created equal. All vaccines have risks – they’re not classified by the federal government as “unavoidably unsafe” for nothing. So it stands to reason that the more vaccines you receive, the greater your risk of injury. If you are not yet like us — pretty well convinced that you will never let anyone come near you or your child with a vaccine-filled syringe again in your lifetime — it is probably at least intuitively obvious that for optimum health you should want to keep your overall vaccine load as low as possible, however you would define that for yourself.

With that idea in mind, we have done blogs on some of the “vaccines we love to hate”:  the hepatitis B vaccine (especially the birth dose) and the yearly flu shot. The blogs give lots of reasons why we consider those vaccines particularly problematic, but the main reason is that both have a very poor risk-to-benefit ratio for the average person. The risks are significant, while the potential benefits are exceptionally low.

The risks are particularly high for those two, because one is given to newborns (hepatitis B), the category at highest risk of permanent neurological damage, and most versions of the other (flu shot) contain mercury, a potent neurotoxin. In addition, the flu shot is recommended by the CDC for nearly everyone yearly — including pregnant women.

The benefits are particularly low for the hepatitis B vaccine, because very few children in this country are at risk of contracting hepatitis B in the first place, it is easy to test for those who are, and any “protection” afforded by the shot is likely to wear off before a child begins what could be termed “risky behavior.” The benefits of the flu vaccine are also likely to be low, as the flu is not likely to be dangerous in most people who get it, on average 100 doses of the vaccine have to be given to prevent a single case of the flu, and approximately 1% of the people who get the vaccine will have a reaction that includes headache, myalgia (aches and pains), and fever and renders them incapable of going about their daily activities. In other words, they feel like they have the flu. So you are just about as likely to feel like you got the flu from the flu shot as you are to have it prevent you from getting the flu.

There is one other category of vaccine that we haven’t discussed much yet that is definitely high on our “hit list”:  Human Papillomavirus (HPV) vaccines, i.e. Gardasil and Cervarix. Both vaccines are designed to prevent HPV infection, a sexually transmitted condition, which that may lead to other health problems, most often cervical cancer or genital warts. 

Awesome! What could be bad about that? A vaccine for cancer! Isn’t that what we were waiting for? At first it sounds terrific, doesn’t it? But as soon as you begin to investigate things get a lot murkier.

gardisil shot

There are 30-40 types of HPV that can affect the genitals. Gardasil, approved for use in 2006 for girls 9-26 and later approved for boys as well, “protects” against four of them (Types 6, 11, 16, and 18). Cervarix, approved for girls in 2009, covers only two types of HPV (Types 16 and 18). Types 16 and 18 cause approximately 70% of cervical cancers, while types 6 and 11 cause approximately 90% of genital warts. Every year there are approximately six million new cases of genital infection with HPV in the U.S.In fact, HPV infection is so common that the majority of sexually active people will have it at some time in their lives. For 70% of those people, the HPV will clear on its own with no symptoms of any kind. The figure rises to 90% within two years. Of the remaining 10%, only half will have cellular changes in the cervix or elsewhere that can lead to cancer, particularly cervical cancer.

Approximately 12,000 women per year are diagnosed with cervical cancer. Almost 4,000 women will die from it every year. Cervical cancer used to be the leading cause of cancer death for women in the U.S., but routine screening in the form of Pap tests and HPV tests have cut the numbers significantly. Cervical cancers tend to be slow growing, taking many years to become deadly. Because the HPV vaccines only cover two or four of the 30-40 strains of HPV, and it’s not clear yet how well it does that, routine Pap exams are still required to ensure continued good health. Unfortunately, a lot of people seem to be under the impression that they no longer need Pap tests once they have received an HPV vaccine. This is absolutely untrue and a very dangerous misconception. If the majority of women did not continue with regular Pap tests, we would actually see the rate of cervical cancer rise with the advent of Gardasil and Cervarix.

A recent government-sponsored study was written up in the June edition of the Journal of Infectious Diseases that claims that overall incidence of HPV infection in sexually active girls 14-19 years old dropped from a pre-vaccine 53.1% to 42.9% (a decline of 19.2%) between 2007 and 2010, indicating high effectiveness for HPV vaccines, despite the fact that only 35% of the study subjects completed the full three-shot series. As Sharlene Bidini, RD, CSO, has pointed out in an article in The Onc, a journal for oncology nurses, there is a huge problem with this conclusion, however; when the numbers are broken down into vaccinated and unvaccinated populations, it becomes clear that the largest drop was in the unvaccinated population. The rate among unvaccinated girls dropped to 38.6% (a decline of 27.3%), while the rate among vaccinated girls only dropped to 50% (a decline of 5.8%), which means that you cannot attribute the decline in incidence to vaccination. In addition, the prevalence of high-risk non-vaccine type HPV infection also declined in similar proportions, making it even more clear that the overall decline in HPV infection was not due to vaccination.

As HPV-related cancers tend to be so slow growing in general, the median age for diagnosis of cervical cancer is 49. Since most of the people getting the vaccines are preteens and teenagers, who are unlikely to develop the disease even without vaccination, there is no data yet to show that use of HPV vaccines will lower the rate of death from cervical cancer, or even the rate of cervical cancer at all. Dr. Diane Harper, one of the lead researchers on the Gardasil trials and an expert on HPV, said, “The combination of HPV vaccine and (Pap) screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level.” Meaning that for a population that uses Pap tests for cervical cancer screening, the incidence of cervical cancer will not be lowered  significantly by the addition of HPV vaccinations.

This point is elaborated in a 2003 study conducted at Stanford University on the cost effectiveness of HPV vaccines. The study assumed 70% of all 12-year-old girls in the country were vaccinated and re-vaccinated every 10 years. (It’s still not clear how long the effects of the vaccines would last. One study claims that after receiving the three-shot Gardasil series antibodies for Type 16, the most virulent type, last for an average of 8.5 years, but Dr. Harper says it’s more like 5 years and that is only for Type 16. If that is the case, many 11 and 12-year-old girls’ immunity would be waning just as they are becoming sexually active.)

The study also assumed an efficacy rate of 75% for the vaccine. That’s a pretty good rate for a vaccine. Some, the flu vaccine for instance, are not that effective, while others, measles for one, are considered to be higher. After approximately 60 years of vaccinating, the study projected that 1,300 lives would be saved and 3,300 cases of cervical cancer would be prevented. Remember, 12,000 women are diagnosed with cervical cancer every year, and approximately 4,000 die from it. Over 60 years, assuming no change in the incidence for other reasons, 240,000 women would die of cervical cancer. Sixty years of vaccinating every 12-year-old we can get our hands on, and only 1,300 of those lives would be saved?  That’s a death rate reduction of only 0.5%.  This is pretty much a “best case scenario” for the vaccine, and that’s the best it can do?

The Stanford study argues that it would be “cost effective” to use the vaccines in this way, but one cost the study doesn’t consider is the possibility of adverse effects of the vaccine, particularly serious adverse effects. It’s a cost you must consider, though, when deciding whether to give your daughter (or son, whose chance of getting or dying from a cancer caused by HPV is significantly lower than your daughter’s) an HPV vaccine.

Merck sponsored a study at Kaiser Permanente that claimed serious adverse events in the form of autoimmune illnesses are no more prevalent in the population vaccinated with Gardasil than the unvaccinated population. Dr. Harper has directly contradicted that:

Neurologists at the American Neurological Association have indeed concluded that Gardasil is temporally associated with autoimmune attacks on the neurologic system. The range of neurologic disorders is unknown.”

So why does Merck’s study claim no increase in autoimmune illness with vaccination? I always look for the obvious holes in a study’s design or logic, especially one that is sponsored by a corporation that stands to make a hell of a lot of money from the results, and this is the statement that has me wondering: “Overall, there were 1,014 new-onset cases of an autoimmune disorder, of which 719 were eligible for case review, and 31 (40%) were confirmed as new onset (i.e. emerged after vaccination).” Out of 1,014 “new-onset” cases of autoimmune disorders, 31 were “confirmed” as new? The cynic in me wonders why 97% of the cases that someone obviously considered “new-onset” were thrown out of consideration in this study. If even 100 of those cases were truly post-vaccination events that would drastically change the results of the study, woudn’t it? Also, it can take several years to diagnose autoimmune conditions, and these young women were tracked for a mere six months following vaccination.

Why am I so cynical? Because it seems that every day I read of another young life tragically altered or ended after the first, second, or third dose of Gardasil. (Since Gardasil was approved first and is given in larger numbers, most of our information on HPV vaccines pertains specifically to Gardasil.) Lives like that of Maddie, daughter of Tracie Toler Moorman, who went from being a happy, healthy 15-year-old to one who was so ill she could not attend school and was on high doses of anti-depressants to deal with the resulting depression. Mystified doctors finally confessed, off the record of course, that they believed Maddie was suffering from vaccine injury as they could find no other explanation for the sudden onset of her debilitating illness. When Maddie was treated for vaccine injury, she started to get better. As Maddie’s mother indicates, a cursory Google search is all it takes to show that Maddie is by no means alone.

Stories like Maddie’s are horrible enough, but even worse are the stories of young girls and women who died suddenly after receiving Gardasil inoculations. Annabelle Morin was a healthy 14-year-old who died suddenly two weeks after her second Gardasil shot. It’s easy to dismiss all these reports as “coincidence,” but in reality how often does a healthy teenage girl die suddenly for no apparent reason? It’s very, very rare.

Annabelle Morin

Israel is considering canceling their plans to administer HPV vaccine to young girls  because of a recent study  published in the July 13 edition of the American Journal of Reproductive Immunology, focusing on three young girls who had adverse reactions to HPV vaccines. All three ceased having menstrual periods after the vaccinations, and hormonal treatment did not help. The diagnosis: primary ovarian failure. The authors documented the “evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.”

Another case of primary ovarian failure was written up in the British Medical Journal,  this time a healthy 16-year-old Australian girl. The authors wanted to know if there was any available data on the effect of Gardasil on ovaries, particularly in rats. They did a Freedom of Information request and found that there was no data on Gardasil’s effect on ovaries, but there was data of the effect on testes. How can it be that a vaccine designed to affect young girls’ reproductive systems was not tested for its effects on ovaries?

Japan also stopped recommending Gardasil in June of this year, because of a high number of serious adverse reactions among the 8.29 million people who have already received the vaccine. There were 106 serious adverse events that sound suspiciously like the advent of autoimmune disease. That corresponds to a rate of 12.8 serious adverse events per million people. (The article says inoculations, but that doesn’t add up, since each person gets 3 inoculations. Something is off.) 

According to Dr. Harper, the incidence of serious adverse effects is actually considerably higher, at least here in the U.S., at 3.4 per 100,000 doses distributed. Since the vaccine series is three injections, that would be approximately 10.2 per 100,000 people vaccinated, or 102 per million people. The rate of cervical cancer in this country is 7 per 100,000, or 70 per million women.  Therefore, according to Dr. Harper, a lead researcher on the Gardasil trials, your chance of having a serious adverse reaction to the Gardasil vaccine is higher than your risk of cervical cancer! Something is wrong with this picture. 

As Lucija Tomljenovic and Christopher A. Shaw asked in a March 2013 paper in Annals of Medicine, are HPV vaccine policy and evidence-based medicine at odds? Given the exceptionally poor risk-to-benefit ratio of the HPV vaccines, in my opinion, the policy of encouraging all 11 or 12-year-old girls and boys, especially those with autoimmune illness in their family histories, is not only “at odds” with “evidence-based medicine,” it’s using every weapon in the federal government’s arsenal to obliterate it!

One Less

Think about it, and do what you can to make sure that your daughter (or son) is “one less” – vaccine injury, that is.